1. A contact lens container for sealing within it a contact lens in a solution, and configured for use with an apparatus including a needle for penetrating the container and introducing through the needle a predetermined substance therein into contact with at least one of the contact lens and solution, and a laser for transmitting radiation onto a penetrated region of the container to thermally reseal the penetrated region and, in turn, seal the contact lens, solution, and predetermined substance within the container, the container comprising: a body defining a chamber; a contact lens and a contact lens solution received within the chamber; a substantially fluid-tight seal formed between the chamber and ambient atmosphere to seal the contact lens and solution within the chamber; a needle penetrable and laser resealable stopper located on the body in fluid communication with the chamber, wherein the stopper is penetrable by the needle to introduce the predetermined substance through the needle and into the chamber, and a penetrated region of the stopper is thermally resealable by application of radiation from the laser thereto to reseal the stopper and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

2. A contact lens container as defined in claim 1, further comprising the predetermined substance.

3. A contact lens container as defined in claim 1, wherein the needle penetrable and laser resealable stopper includes an inner layer in fluid communication with the chamber that is compatible with the contact lens, solution and the predetermined substance, and an outer layer that is needle penetrable and laser resealable.

4. A contact lens container as defined in claim 3, wherein the inner layer does not leach more than a predetermined amount of leachables into at least one of the contact lens, solution and predetermined substance.

5. A contact lens container as defined in claim 2, wherein the body includes a base surface forming a base portion of the chamber, the base surface defines at least one substantially convex portion that supports a substantially concave surface of the contact lens thereon and defines an interface therebetween, and the interface is in fluid communication with the stopper for receiving the predetermined substance therein.

6. A contact lens container as defined in claim 5, wherein the interface contains a greater concentration of the predetermined substance than the other portions of the chamber.

7. A contact lens container as defined in claim 6, wherein the concave side of the contact lens defining the interface includes a greater concentration of the predetermined substance than does the opposing convex side of the contact lens.

8. A contact lens container as defined in claim 5, wherein the base surface defines a plurality of relatively raised surface areas and relatively recessed surfaces areas between relatively raised surface areas, and the relatively recessed surface areas are in fluid communication with the stopper for receiving predetermined substance therein.

9. A contact lens container as defined in claim 8, wherein the relatively recessed surface areas are defined by substantially radially extending recesses, and the body further defines a fluid passageway in fluid communication between the recesses and the stopper for introducing the predetermined substance therethrough and into the recesses.

10. A contact lens container as defined in claim 2, wherein the predetermined substance is selected from the group consisting of a preservative; a chelating agent; an anionic component; a cationic component; a zwitterionic component; an acid; a base; an alcohol; a glycol; a polymeric agent; a reducing agent; a salt; a surfactant; an antioxidant; a cleaning agent; a disinfecting agent; a wetting agent; a hydrating agent; a coloring agent; an ultraviolet absorbing agent; a gas; a lipid; an oil; a phospholipid; a lubricant; a buffering agent; a mineral; a nutrient; a vitamin; a biological macromolecule; a small molecule; an antibiotic; a biopolymer; a protein; and a nucleic acid.

11. A contact lens container as defined in claim 1, wherein the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the penetrated region by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the penetrated region in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the stopper.

12. A contact lens container as defined in claim 1, wherein the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the needle and stopper during needle penetration thereof.

13. A contact lens container as defined in claim 1, wherein the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the penetrated region thereof by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pigment in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the penetrated region in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the needle and stopper during needle penetration thereof.

14. An assembly comprising a contact lens container as defined in claim 1; a filling apparatus comprising a needle manifold including a plurality of needles spaced relative to each other and movable relative to a container support for penetrating a plurality of containers mounted on the support within the filling apparatus, introducing the predetermined substance into the containers through the needles, and withdrawing the needles from the filled containers; and a plurality of laser optic assemblies, wherein each laser optic assembly is connectable to a source of laser radiation, and is focused substantially on a penetration spot of the respective stopper for applying laser radiation thereto and resealing the respective penetrated region.

15. A contact lens container for sealing within it a contact lens in a solution, and configured for use with an apparatus including a needle for penetrating the container and introducing through the needle a predetermined substance therein into contact with at least one of the contact lens and solution, and a laser for transmitting radiation onto a penetrated region of the container to thermally reseal the penetrated region and, in turn, seal the contact lens, solution, and predetermined substance within the container, the container comprising: first means for forming a chamber; a contact lens and a contact lens solution received within the chamber; a substantially fluid-tight seal between the chamber and ambient atmosphere to seal the contact lens and solution within the chamber; second means in fluid communication with the chamber for penetration by the needle to introduce the predetermined substance through the needle and into the chamber, and for thermal resealing by application of radiation from the laser thereto to reseal the second means and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

16. A contact lens container as defined in claim 15, wherein the first means is a body, and the second means is a needle penetrable and laser resealable stopper in fluid communication with the chamber that is penetrable by the needle to introduce the predetermined substance through the needle and into the chamber and is thermally resealable by application of radiation from the laser thereto to reseal a penetrated region of the stopper and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

17. A method of providing a contact lens container containing therein a contact lens and a solution, and adding thereto a predetermined substance, the method comprising the following steps: providing a contact lens container including a body defining a contact lens storage chamber, and a needle penetrable and laser resealable stopper in fluid communication with the chamber; introducing the contact lens and solution into the chamber, and sealing the contact lens and solution within the chamber relative to the ambient atmosphere; inserting a needle through the stopper and into fluid communication with the chamber; introducing the predetermined substance through the needle and into the chamber; withdrawing the needle from the stopper; and applying laser radiation to a penetrated region of the stopper, thermally resealing the penetrated region of the stopper and, in turn, sealing the contact lens, solution and predetermined substance within the chamber.

18. A method as defined in claim 17, further comprising the step of terminally sterilizing the contact lens container with the contact lens and solution sealed therein prior to introducing the predetermined substance into the container.

19. A method as defined in claim 18, further comprising the step of introducing the predetermined substance into an interface formed between a substantially concave surface of the contact lens and a wall of the chamber, and at least one of (i) impregnating at least a portion of the predetermined substance into the concave surface of the contact lens, and (ii) depositing at least a portion of the predetermined substance onto the concave surface of the contact lens.

20. A method as defined in claim 19, further comprising the step of applying a greater amount of the predetermined substance to the concave side of the contact lens in comparison to the opposing convex side of the contact lens.

21. A method as defined in claim 20, further comprising the step of applying the concave side of the contact lens into contact with a user’s cornea such that a greater amount of the predetermined substance is located within the interface between the concave side of the contact lens and the eye in comparison to the opposite convex side of the contact lens.
Contact Lens Description
FIELD OF THE INVENTION

The present invention relates to a contact lens storage container, also known as a blister package, having a needle penetrable and thermally resealable stopper for aseptically introducing a substance into the contact lens storage container through the stopper and thermally resealing the resulting penetration hole in the stopper, and to apparatus and methods for filling such a container.

BACKGROUND OF THE INVENTION

Referring to FIG. 1, a prior art blister package 10 includes a cavity 12 that receives a contact lens solution or “packing” solution and a contact lens within the solution. The cavity 12 is covered with a sealing flat covering layer (not shown) that is detachably sealed to a flange 14 that surrounds the cavity 12. The flange 14 of the blister package 10 defines gripping areas 16 that allow a user to grip the package and unseal the covering layer to access the contact lens stored within the cavity 12. The packing solution may have any of a variety of components, additives or other substances added thereto, such as physiologically compatible surfactants, cleaning agents, wetting agents, etc., as shown, for example, in U.S. Pat. No. 5,882,687. When manufacturing some such blister packages, the contact lens is placed within the cavity 12 together with the packing solution and any components, additives or other substances added thereto, and then the covering layer is sealed to the flange 14 to seal the contact lens, solution and any additives, etc. therein. The sealed package is then terminally sterilized, such as by the application of heat or gamma radiation thereto.

One of the drawbacks associated with such prior art blister packages and apparatus and methods for filling such packages is that the additives or other substances are introduced into the package prior to terminal sterilization. As a result, additives or other substances that can be damaged by terminal sterilization cannot be used. In other situations, terminal sterilization can negatively affect the additives or other substances and/or the solution or contact lens packaged with such additives or other substances.

Another drawback associated with prior art contact lens storage containers, and apparatus and methods for introducing additives, such as medicaments, to the containers, and/or to an eye after application of a contact lens to the eye, is that a substantial portion of the medicament or other additive is located on the external or convex surface of the contact lens. When the user blinks, the fluid within the eye, such as the tear film, can relatively rapidly flush away any such medicament or other additive located on the external or convex surface of the contact lens. The flushed medicament or other additive can flow into the lacryomo nasal duct (also referred to as the lachrymal nasal duct, i.e., a duct running between the base of the eye and the nasal passageway) which can, in turn, lead to systemic absorption of the flushed additive or other substance and, in some cases, give rise to systemic side effects.

Accordingly, it is an object of the present invention to overcome one or more of the above-described drawbacks and disadvantages of the prior art.

SUMMARY OF THE INVENTION

In accordance with a first aspect, the present invention is directed to a contact lens container for sealing within it a contact lens in a solution. The contact lens container is configured for use with an apparatus including a needle for penetrating the container and introducing through the needle a predetermined substance therein into contact with the contact lens and/or solution. A laser of the apparatus transmits radiation onto a penetrated region of the container to thermally reseal the penetrated region and, in turn, seal the contact lens, solution, and predetermined substance within the container. The container comprises a body defining a chamber; a contact lens and a contact lens solution received within the chamber; and a substantially fluid-tight seal formed between the chamber and ambient atmosphere to seal the contact lens and solution within the chamber. A needle penetrable and laser resealable stopper is located on the body in fluid communication with the chamber. The stopper is penetrable by the needle to introduce the predetermined substance through the needle and into the chamber, and a penetrated region of the stopper is thermally resealable by application of radiation from the laser thereto to reseal the stopper and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

In one embodiment of the present invention, the needle penetrable and laser resealable stopper includes an inner layer in fluid communication with the chamber that is compatible with the contact lens, solution and the predetermined substance, and an outer layer that is needle penetrable and laser resealable. In one such embodiment, the inner layer does not leach more than a predetermined amount of leachables into the contact lens, solution and/or predetermined substance.

In one embodiment of the present invention, the body includes a base surface forming a base portion of the chamber. The base surface defines at least one substantially convex portion that supports a substantially concave surface of the contact lens thereon, and defines an interface therebetween. The interface is in fluid communication with the stopper for receiving the predetermined substance therein. Preferably, the interface contains a greater concentration of the predetermined substance than do the other portions of the chamber. In one such embodiment, the concave side of the contact lens defining the interface includes a greater concentration of the predetermined substance than does the opposing convex side of the contact lens. In one such embodiment, the base surface defines a plurality of relatively raised surface areas and relatively recessed surfaces areas between relatively raised surface areas. The relatively recessed surface areas are in fluid communication with the stopper for receiving predetermined substance therein. In one such embodiment, the relatively recessed surface areas are defined by substantially radially extending recesses, and the body further defines a fluid passageway in fluid communication between the recesses and the stopper for introducing the predetermined substance therethrough and into the recesses.

In one embodiment of the present invention, the predetermined substance is selected from the group including a preservative; a chelating agent; an anionic component; a cationic component; a zwitterionic component; an acid; a base; an alcohol; a glycol; a polymeric agent; a reducing agent; a salt; a surfactant; an antioxidant; a cleaning agent; a disinfecting agent; a wetting agent; a hydrating agent; a coloring agent; an ultraviolet absorbing agent; a gas; a lipid; an oil; a phospholipid; a lubricant; a buffering agent; a mineral; a nutrient; a vitamin; a biological macromolecule; a small molecule; an antibiotic; a biopolymer; a protein; and a nucleic acid.

In one embodiment of the present invention, the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the penetrated region by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the penetrated region in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the stopper.

In one embodiment of the present invention, the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the needle and stopper during needle penetration thereof.

In one embodiment of the present invention, the stopper includes a thermoplastic elastomer that is heat resealable to hermetically seal the penetrated region thereof by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pigment in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the penetrated region in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the needle and stopper during needle penetration thereof.

In accordance with another aspect of the present invention, the contact lens container is part of an assembly including a filling apparatus comprising a needle manifold including a plurality of needles spaced relative to each other and movable relative to a container support for penetrating a plurality of containers mounted on the support within the filling apparatus, introducing the predetermined substance into the containers through the needles, and withdrawing the needles from the filled containers. The filling apparatus further includes a plurality of laser optic assemblies, wherein each laser optic assembly is connectable to a source of laser radiation, and is focused substantially on a penetration spot of a respective stopper for applying laser radiation thereto and resealing the respective penetrated region.

In accordance with another aspect, the present invention is directed to a contact lens container for sealing within it a contact lens in a solution. The container is configured for use with an apparatus including a needle for penetrating the container and introducing through the needle a predetermined substance therein into contact with the contact lens and/or solution. A laser of the apparatus transmits radiation onto a penetrated region of the container to thermally reseal the penetrated region and, in turn, seal the contact lens, solution, and predetermined substance within the container. The container comprises first means for forming a chamber; a contact lens and a contact lens solution received within the chamber; a substantially fluid-tight seal between the chamber and ambient atmosphere to seal the contact lens and solution within the chamber; and second means in fluid communication with the chamber for penetration by the needle to introduce the predetermined substance through the needle and into the chamber, and for thermal resealing by application of radiation from the laser thereto to reseal the second means and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

In a currently preferred embodiment of the present invention, the first means is a body, and the second means is a needle penetrable and laser resealable stopper in fluid communication with the chamber that is penetrable by the needle to introduce the predetermined substance through the needle and into the chamber, and is thermally resealable by application of radiation from the laser thereto to reseal a penetrated region of the stopper and, in turn, seal the contact lens, solution and predetermined substance within the chamber.

In accordance with another aspect, the present invention is directed to a method of providing a contact lens container containing therein a contact lens and a solution, and adding thereto a predetermined substance. The method comprises the following steps: (a) providing a contact lens container including a body defining a contact lens storage chamber, and a needle penetrable and laser resealable stopper in fluid communication with the chamber; (b) introducing the contact lens and solution into the chamber, and sealing the contact lens and solution within the chamber relative to the ambient atmosphere; (c) inserting a needle through the stopper and into fluid communication with the chamber; (d) introducing the predetermined substance through the needle and into the chamber; (e) withdrawing the needle from the stopper; and (f) applying laser radiation to a penetrated region of the stopper, thermally resealing the penetrated region of the stopper and, in turn, sealing the contact lens, solution and predetermined substance within the chamber.

The method preferably further comprises the step of terminally sterilizing the contact lens container with the contact lens and solution sealed therein prior to introducing the predetermined substance into the container.

In one embodiment the method further comprises the step of introducing the predetermined substance into an interface formed between a substantially concave surface of the contact lens and a wall of the chamber, and (i) impregnating at least a portion of the predetermined substance into the concave surface of the contact lens, and/or (ii) depositing at least a portion of the predetermined substance onto the concave surface of the contact lens. In one such embodiment, the method further comprises the step of applying a greater amount of the predetermined substance to the concave side of the contact lens in comparison to the opposing convex side of the contact lens.

Also in one such embodiment, the method further comprises the step of applying the concave side of the contact lens into contact with a user’s cornea such that a greater amount of the predetermined substance is located within the interface between the concave side of the contact lens and the eye in comparison to the opposite convex side of the contact lens.

One advantage of the present invention is that the predetermined substance can be aseptically introduced and sealed within the container after terminally sterilizing the contact lens and solution within the container, thus avoiding the problems encountered in the prior art in connection with introducing such predetermined substances into the container prior to terminal sterilization as described above. Yet another advantage of certain embodiments of the present invention is that a greater concentration of a predetermined substance can be introduced into and/or on the concave side of the contact lens, thus enabling a greater concentration of the substance to be sandwiched between the contact lens and the user’s eye, and thereby allowing a relatively sustained release of the substance into the eye and substantially preventing the systemic absorption of the substance and negative side effects encountered in the prior art.

Other advantages of the present invention and/or of the currently preferred embodiments thereof will become more readily apparent in view of the following detailed description of the currently preferred embodiments and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art blister package for storing a contact lens.

FIG. 2 is a top perspective view of a contact lens storage container according to an exemplary embodiment of the invention.

FIG. 3 is a bottom perspective view of the contact lens storage container of FIG. 2.

FIG. 4 is a bottom perspective view of the contact lens storage container of FIG. 2 showing a filling needle inserted into a resealable stopper of the container for introducing an additive or other substance into the container after terminal sterilization of the contact lens and packing solution therein.

FIG. 5 is a perspective cross-sectional view of the contact lens storage container and filling needle of FIG. 4.

FIG. 6 is a somewhat schematic cross-sectional view of the contact lens storage container and filling needle of FIG. 4 showing the flow of additive and/or other substance from the filling needle, through the resealable stopper, and into the interface between the concave side of the contact lens and the base wall of the storage cavity of the container.

FIG. 7 is a top perspective view of a second embodiment of a contact lens storage container according to an exemplary embodiment of the invention.

FIG. 8 is an exploded side elevational view of the contact lens storage container of FIG. 7.

FIG. 9 is another side elevational view of the contact lens storage container of FIG. 7 showing the filling needle adjacent to the resealable stopper.

FIG. 10 is a top perspective view of a third embodiment of a contact lens storage container according to an exemplary embodiment of the invention.

FIG. 11 is a schematic illustration of an exemplary embodiment of an apparatus of the present invention for molding, assembling, needle filling and laser resealing contact lens storage containers.

FIG. 12 is a perspective view of a first exemplary embodiment of a filling needle used in the apparatus of FIG. 11 for needle filling the contact lens storage containers.

FIG. 13 is a cross-sectional view of a tip portion of the needle of FIG. 12.

FIG. 14 is a perspective view of a second exemplary embodiment of a filling needle used in the apparatus of FIG. 11 for needle filling the contact lens storage containers.

FIG. 15 is a cross-sectional view of a tip portion of the needle of FIG. 14.

FIG. 16 is a perspective view of a second exemplary embodiment of a filling needle used in the apparatus of FIG. 11 for needle filling the contact lens storage containers.

FIG. 17 is a cross-sectional view of a tip portion of the needle of FIG. 16.

DETAILED DESCRIPTION OF THE CURRENTLY PREFERRED EMBODIMENTS

Referring to FIGS. 2-6, a contact lens storage container, also known as a blister package (referred to herein as a “contact lens storage container” or “container”) is indicated generally by the reference numeral 20. The container 20 includes a body 21 defining a contact lens storage recess or cavity 22. In the illustrated embodiment, the base of the cavity 22 is defined by a substantially dome-shaped wall 24. The dome-shaped base 24 defines a plurality of radially extending recesses or slits 26 that are angularly spaced relative to each other, and a central recessed portion 28 in fluid communication with the radially extending recesses 26. As shown typically in FIG. 2, the base 24 defines a plurality of inner surface portions 30 extending between the radially extending recesses 26 and together forming a substantially dome-shaped or convex surface for supporting thereon a contact lens (not shown) received within the storage cavity 22. As shown typically in FIG. 3, the base 24 further defines on outer surface 32 located on an opposite side of the base wall relative to the inner surface 30.

The body 21 further defines a substantially planar flange 31 extending about the periphery of the storage cavity 22, and a plurality of tabs 33 extending downwardly from the end portions of the flange on opposite sides of the body relative to each other. One or more of the tabs 33 and/or the flange 31 define gripping areas that allow a user to grip the body to hold the container. The flange 31 of the body 21 defines a substantially circular raised sealing surface 35 that is located on the upper surface of the flange 31 and extends about the periphery of the storage cavity 22. As shown typically in FIG. 6, the container 20 further includes a removable sealing cover 37 that is sealed to the sealing surface 35 after loading the storage cavity 22 with a contact lens and packing solution to form a fluid tight or hermetic seal between the interior and exterior of the storage cavity. In one embodiment, the sealing cover 37 is a laminated foil cover, and an adhesive is used to releasably secure and seal the foil cover to the sealing surface 35 and/or flange 31, wherein both the foil cover and adhesive are of types known to those of ordinary skill in the pertinent art. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the body 21, cover 37, and mechanism for releasably sealing the cover to the body may take any of numerous different types or configurations that are currently known, or that later become known.

As shown in FIGS. 3-6, the body 21 further defines a filling boss 34 extending outwardly from a central region of the outer surface 32 of the base wall 24. As shown in FIG. 5, the filling boss 34 defines an internal stopper recess 36 formed in the end portion of the boss, and a fluid conduit or channel 38 extending through the boss and in fluid communication with the central region 28 and radially-extending recesses 26 of the base 24 and thus in fluid communication with the storage cavity 22. A resealable stopper 40 is received within the stopper recess 36 of the filling boss 34. As indicated further below, the stopper 40 and filling boss 34 may be formed in any of numerous different ways, out of any of numerous different materials, and may take any of numerous different configurations, that are currently known, or that later become known. For example, the stopper 40 can be inserted into the boss and fixedly secured thereto, such as by a locking ring or other locking member, or by an adhesive, or the stopper may be co-molded with the body, such as by over-molding the stopper to the body.

As shown typically in FIGS. 4-6, the resealable stopper 40 is penetrable by a hypodermic or other type of filling needle or injection member 50 that is inserted through the resealable stopper 40 such that the tip of the needle is received within the fluid channel 38 in order to dispense a substance, such as a medicament, into the cavity 22 and thus into the packing solution and/or into contact with the contact lens stored therein. In the illustrated embodiment, the fluid channel 38 is sized to allow for enough space for the bevel and filling aperture(s) of the filling needle to enter the channel and introduce the substance therein. As shown typically in FIG. 6, when the substance is injected through the needle 50 and into the channel 38, the substance flows through the central region 28 of the base wall 24, and into the radially-extending recesses 26. As a result, as shown typically in FIG. 6, the substance is deposited into the interface between the contact lens and the base wall. Once the desired amount of substance is introduced into the container 20, the needle 50 is withdrawn from the stopper 40, a heat or other energy source is applied to at least the portion of the resealable stopper 40 punctured by the needle 50 to, in turn, seal the punctured portion and hermetically seal the substance within the container. Thus, the substance may be added to the container 20 after the contact lens and packing solution and/or other components are sealed within the container and terminally sterilized.

One advantage of the illustrated embodiment of the invention is that a significantly greater amount of the substance can be introduced into the interface between the contact lens and the base wall 24 to thereby provide a greater concentration of the substance on the concave or inner side of the contact lens in comparison to the convex or outer side of the contact lens. Accordingly, when the contact lens is removed from the container 20 and applied to an eye, the portion of the contact lens containing the greater concentration of substance is placed into direct contact with cornea of the eye. The cornea can be a relatively slow absorbing region of the eye as compared to other regions of the eye, and thus the residence time of the substance on the eye for the substance located on the concave surface of the contact lens can be significantly greater than the residence time of any substance located on the convex side of the lens and therefore a relatively sustained release of the substance into the eye can be achieved. In addition, the draining of substantial amounts of the substance into the nasal ducts and the associated systemic absorption of such substances as encountered in the prior art can be substantially avoided.

However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the substance be introduced into all regions of the storage cavity, can be introduced into selective regions of the storage cavity, can be substantially uniformly applied to all surfaces of the contact lens, can be applied to substantially only select surfaces of the contact lens, and/or can be selectively applied in different concentrations to different surfaces or different surface regions of the contact lens. For example, if the surface of the lens that is concave when located in an eye is normally convex when located in the storage container, a greater concentration of the substance can be applied to the convex surface of the lens when located in the storage container.

After injecting the container 20 with the substance and withdrawing the needle 50 from the stopper 40, the penetrated region of the stopper defines a needle hole along the path of the withdrawn needle. Upon withdrawing the needle, the material of the resealable stopper may be sufficiently resilient to close upon itself in the penetrated region and thereby maintain the container in a sealed condition. However, as described above, vapors, gases and/or liquid may be allowed over time to pass through the needle hole, and therefore container is passed through a sealing station, as shown and described below with reference to FIG. 11, to reseal the resulting needle hole in the stopper 40 after withdrawing the needle therefrom. When the 40 is heated by a laser or other such thermal or radiation source, and maintained at a sufficient temperature, the material of the resealable stopper fuses and reseals the needle hole. As a result, the needle hole is eliminated from the exterior region of the resealable stopper to thereby maintain a hermetic seal between the interior and exterior of the storage cavity.

Referring to FIGS. 7-9, another exemplary embodiment of a contact lens storage container of the invention is indicated generally by the reference numeral 120. The contact lens storage container 120 is substantially similar to the container 20 described above with reference to FIGS. 2-6, and therefore like reference numerals preceded by the number “1″ are used to indicate like elements. A primary difference of the container 120 in comparison to the container 20 above is that the filling boss 134 and stopper 40 are spaced laterally relative to the storage cavity 122, and the fluid channel 138 extends laterally between the inner surface of the stopper 140 and the storage cavity 122. Also in this embodiment, the interior surface 130 of the base wall 124 of the storage cavity 122 defines a substantially smooth concave shape as in certain prior art contact lens storage containers. When the substance is introduced through a needle (not shown) that penetrates the stopper, the substance flows through the channel 138 and into the cavity 122. Because the base wall 130 of the cavity is substantially convex, the substance flows into contact with the concave side of the contact lens. Accordingly, this embodiment can facilitate forming a greater concentration of the substance on the inner or concave side of the contact lens that contacts the eye as opposed to the outer or convex side of the contact lens. Another advantage of this embodiment is that the tooling used to mold and/or assemble prior art containers can be modified to form the containers of the invention.

Referring to FIG. 10, another exemplary embodiment of a contact lens storage container of the invention is indicated generally by the reference numeral 220. The contact lens storage container 220 is substantially similar to the containers 20 and 120 described above, and therefore like reference numerals preceded by the number “2″, or preceded by the numeral “2″ instead of the numeral “1″, are used to indicate like elements. A primary difference of the container 220 is that the stopper 240 is located at an edge 238 of the container. The channel 236 connects the stopper 40 in fluid communication with the cavity 222. When the substance is introduced through a needle (not shown) that penetrates the stopper, the substance flows through the channel 238 and into the cavity 222. Because the base wall 230 of the cavity is substantially convex, the substance flows into contact with the concave side of the contact lens. Accordingly, this embodiment can facilitate forming a greater concentration of the substance on the inner or concave side of the contact lens that contacts the eye as opposed to the outer or convex side of the contact lens.

The substance that is injected through the stopper 40 can be an active pharmaceutical ingredient, such as any of the following non-limiting examples: a preservative; a chelating agent, for example, EDTA; an anionic component; a cationic component; a zwitterionic component; an acid; a base; an alcohol; a glycol; a polymeric agent; a reducing agent; a salt, comprised of, for example sodium, calcium, magnesium, phosphate or chloride; a surfactant; an antioxidant; a cleaning agent; a disinfecting agent; a wetting agent; a hydrating agent; a coloring agent; an ultraviolet absorbing agent; a gas, for example, nitrogen, oxygen, or carbon dioxide; a lipid; an oil; a phospholipid; a lubricant; a buffering agent; a mineral; a nutrient; a vitamin; or a drug, for example, a biological macromolecule, a small molecule, or an antibiotic; or a biopolymer, such as a peptide, a protein, for example an enzyme, or a nucleic acid. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the substance also may be any of numerous different pharmaceutical ingredients or other substances that are currently known, or that later become known, that can be deposited onto and/or absorbed into one or more surfaces of a contact lens, or that can be introduced into the packing solution for the contact lens. In addition, the packing solution may take any the form of any of numerous different contact lens solutions that are currently known or that later become known, including with limitation saline solutions and/or cleaning solutions.

If desired, and with reference to FIG. 11, the stopper 40 can be co-molded with body 21, such as by over-molding the stopper to the body in a molding machine 68. Alternatively, the stopper 40 may be molded in the same mold as the container body 21, and at least one of the stopper and the body may be assembled within or adjacent to the mold in accordance with the teachings of commonly-assigned U.S. patent application Ser. Nos. 11/074,454 and 11/074,513 incorporated by reference below, and U.S. Provisional Patent Application Ser. No. 60/727,899 filed Oct. 17, 2005, entitled “Sterile De-Molding Apparatus And Method”, which is hereby expressly incorporated by reference as part of the present disclosure. However, as may be recognized by those of ordinary skill in the pertinent art, the stopper and body can be molded and assembled in any of numerous different ways that are currently known, or that later become known. As also shown in FIG. 11, the assembled stoppers and container bodies are fed into a transfer station 70. Preferably, the laminar flow source 72 directs a substantially laminar flow 74 of sterile air or other gases over the assembled stopper and container bodies during molding, transfer and contact lens assembly.

The transfer station 70 may include any of numerous different types of container conveying systems that are currently known or that later become known for performing the function of transporting the assembled containers 20 therethrough. For example, the conveying system may include a vibratory feed table or tray or other input device for receiving the assembled containers 20 into the transfer station 70, and one or more conveying systems operatively coupled to the input device for transporting the containers therefrom in a single file or other desired configuration. For example, the conveying system may include a vibratory feed system, a closed loop conveyor, or a rotatably driven lead screw. As may be recognized by those or ordinary skill in the pertinent art based on the teachings herein, the conveying system may take the form of any of numerous different conveying systems that are currently known or that later become known.

The contact lens and hydrating solution are added to the container 20 at a contact lens assembly station 76. In addition, the container 20 is sealed with a foil or other cover 37 (FIG. 6), as is known in the art. While these steps have been shown as occurring at one step within the contact lens assembly station, it is understood that these steps may also occur separately, at separate stations. The container 20 is then terminally sterilized, such as by exposing the assembly to heat, beta and/or gamma radiation in a manner known to those of ordinary skill in the pertinent art. After sterilizing, the exposed end of the stopper 42 may be covered with a cap and/or sealing member so that the exposed end of the stopper 42 remains sterile when the container 20 is moved from one location to another. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the containers can be terminally sterilized in any of numerous different ways that are currently known, or that later become known.

Each container 20 including the contact lens and solution aseptically sealed within the container, is then needle filled with a predetermined substance through the stopper 40 and the resulting needle hole in the stopper is thermally resealed in accordance with the teachings of any of the following patent applications and patents that are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. patent application Ser. No. 10/766,172 filed Jan. 28, 2004, entitled “Medicament Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial”, which is a continuation-in-part of similarly titled U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation of similarly titled co-pending U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional Application Ser. No. 60/182,139, filed Feb. 11, 2000; similarly titled U.S. Provisional Patent Application No. 60/443,526, filed Jan. 28, 2003; similarly titled U.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers And Methods Of Making And Filling Same”; U.S. patent application Ser. No. 10/983,178 filed Nov. 5, 2004, entitled “Adjustable Needle Filling and Laser Sealing Apparatus and Method; U.S. patent application Ser. No. 11/070,440 filed Mar. 2, 2005, entitled “Apparatus and Method for Needle Filling and Laser Resealing”; U.S. patent application Ser. No. 11/074,513 filed Mar. 7, 2005, entitled “Apparatus for Molding and Assembling Containers with Stoppers and Filling Same; and U.S. patent application Ser. No. 11/074,454 filed Mar. 7, 2005, entitled “Method for Molding and Assembling Containers with Stoppers and Filling Same”.

In accordance with such teachings, the needle filling and laser resealing station 78 comprises a needle manifold including a plurality of needles 50 spaced relative to each other and movable relative to a conveyor holding the containers 20 for penetrating a plurality of containers 20 mounted on the portion of the conveyor within the filling station, introducing the predetermined substance into the containers through the needles, and withdrawing the needles from the filled containers. The laser resealing station comprises a plurality of laser optic assemblies, and each laser optic assembly is located over a respective container position of the conveyor located within the respective laser resealing station. Each laser optic assembly is connectable to a source of laser radiation, and is focused substantially on a penetration spot on the stopper of the respective container 20 for applying laser radiation thereto and resealing the respective needle aperture. The laser resealing station may preferably further comprise a plurality of optical sensors. Each optical sensor is mounted adjacent to a respective laser optic assembly and is focused substantially on the laser resealed region of a stopper of the respective laser optic assembly, and generates signals indicative of the temperature of the laser resealed region to thereby test the integrity of the thermal seal.

As disclosed above, the needle 50 is used to inject a substance into the container 20. In particular, referring to FIGS. 12 and 13, a first embodiment of a needle 50 has a pointed, non-coring tip 52 in which an angle a of the tip 52 relative to the body of the needle 50 in cross-section is within the range of about 25.degree. to about 35.degree., preferably about 28.degree. to about 32.degree., and most preferably about 30.degree.. The smooth, sharply-pointed, gradually increasing angle of the needle tip allows for a relatively smooth, and gradual expansion of the needle hole upon penetrating the stopper. Further, the memory of the preferred thermoplastic blends of the stopper causes the needle hole to substantially close on itself upon withdrawing the needle therefrom, thus reducing the requisite area of impingement by the laser beam for resealing, and reducing cycle time. In addition, this further reduces the possibility of contaminating the interior of the container between needle filling and laser resealing. If desired, the stopper surface may be Teflon coated or otherwise coated with a low-friction material to further reduce friction, and thus the formation of particles, at the needle/stopper interface.

The needle tip further defines axially oblong flow aperture 54 on a side of the needle 50. The aperture 54 is located approximately a distance “d” from an end of the tip 52 of the needle 50. The distance “d” can range from about 0.01 inch to about 0.05 inch and in an exemplary embodiment is about 0.038 inch. The fluid in the needle 50 flows out the aperture 54 because an end of the needle 50 is blocked with a pin 62 that may be laser welded into the opening. The pin 62 allows for the needle 50 to be non-coring. In an exemplary embodiment, the needle width is about 0.016 inch diameter. A bushing 56 is welded onto the outside diameter of the needle 50 so that needle 50 can be easily mounted in a machine.

Referring to FIGS. 14 and 15, another exemplary embodiment of a needle 150 is illustrated. The needle 150 is similar to the needle 50 described above, and therefore like reference numerals preceded by the numeral “1″ are used to indicate like elements. The needle 150 has a conically-pointed, non-coring tip 152 (i.e., a “pencil point” tip), wherein the included angle a of the tip in cross-section is within the range of about 30.degree. to about 50.degree., preferably about 37.degree. to about 43.degree., and most preferably about 40.degree.. The needle tip further defines at least one axially oblong flow aperture 154 on a side of the needle 150. The aperture 154 is located approximately a distance “d” from an end of the tip 152 of the needle 150. The distance “d” can range from about 0.01 inch to about 0.05 inch and in an exemplary embodiment is about 0.030 inch.

Referring to FIGS. 16 and 17, another exemplary embodiment of a needle 250 is illustrated. The needle 250 is similar to the needles 50 and 150 described above, and therefore like reference numerals preceded by the numeral “2″ are used to indicate like elements. The needle 250 has a conically-pointed, non-coring tip 252 (i.e., a “pencil point” tip), wherein the included angle “a” of the tip in cross-section is within the range of about 33.degree. to about 63.degree., preferably about 50.degree. to about 56.degree., and most preferably about 53.degree.. The needle tip further defines at least one axially oblong flow aperture 254 on a side of the needle 250. The aperture 254 is located approximately a distance “d” from an end of the tip 252 of the needle 250. The distance “d” can range from about 0.01 inch to about 0.05 inch and in an exemplary embodiment is about 0.030 inch. The fluid in the needle 250 flows out the aperture 254 because an end of the needle 250 is blocked with a pin 262 that may be laser welded into the opening, which allows for the needle to be non-coring.

In an exemplary embodiment, the needle/stopper interface is treated to reduce the degree of friction therebetween to further reduce the formation of particles during the needle stroke. In one embodiment, the needle is tungsten carbide carbon coated. In another embodiment, the needle is electro-polished stainless steel. In another embodiment, the needle is Teflon coated. In yet another embodiment, the needle is titanium coated to reduce friction at the needle/stopper interface. In another embodiment, grooves are formed in the outer surface of the needle to vent the displaced gas from the chamber. In one such embodiment, a cylindrical sleeve surrounds the grooves to prevent the stopper material from filling or blocking the grooves (partially or otherwise) and thereby preventing the air and/or other gases within the container from venting therethrough. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the non-coring needles may be made in any of numerous different ways, and may take any of numerous different configurations that are currently known, or that later become known.

In the illustrated embodiment of the present invention, the stopper 40 is preferably made of a thermoplastic/elastomer blend, and may be the same material as those described in the co-pending patent applications and/or patents incorporated by reference above. Accordingly, in one such embodiment, the stopper 40 is a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the needle penetration region.

In one embodiment, the stopper 40 is formed of a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the stopper to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the needle and second material portion during needle penetration thereof. In one such embodiment, the stopper includes less than or equal to about 40% by weight styrene block copolymer, less than or equal to about 15% by weight olefin, less than or equal to about 60% by weight mineral oil, and less than or equal to about 3% by weight pigment and any processing additives of a type known to those of ordinary skill in the pertinent art.

In one embodiment, the stopper 40 is made of a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pigment in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the needle and second material portion during needle penetration thereof

In one embodiment, the pigment is sold under the brand name Lumogen.TM. IR 788 by BASF Aktiengesellschaft of Ludwigshafen, Germany. The Lumogen IR products are highly transparent selective near infrared absorbers designed for absorption of radiation from semi-conductor lasers with wavelengths near about 800 nm. In this embodiment, the Lumogen pigment is added to the elastomeric blend in an amount sufficient to convert the radiation to heat, and melt the stopper material, preferably to a depth equal to at least about 1/3 to about 1/2 of the depth of the needle hole, within a time period of less than or equal to about 5 seconds, preferably less than about 3 seconds, and most preferably less than about 11/2 seconds. The Lumogen IR 788 pigment is highly absorbent at about 788 nm, and therefore in connection with this embodiment, the laser preferably transmits radiation at about 788 nm (or about 800 nm). One advantage of the Lumogen IR 788 pigment is that very small amounts of this pigment can be added to the elastomeric blend to achieve laser resealing within the time periods and at the resealing depths required or otherwise desired, and therefore, if desired, the needle penetrable and laser resealable stopper may be transparent or substantially transparent. This may be a significant aesthetic advantage. In one embodiment of the invention, the Lumogen IR 788 pigment is added to the elastomeric blend in a concentration of less than about 150 ppm, is preferably within the range of about 10 ppm to about 100 ppm, and most preferably is within the range of about 20 ppm to about 80 ppm. In this embodiment, the power level of the 800 nm laser is preferably less than about 30 Watts, or within the range of about 8 Watts to about 18 Watts.

Preferably the material used to form the stopper is selected from materials (i) that are regulatory approved for use in connection with the respective contact lens, solution, and predetermined substance to be added thereto, and preferably for direct contact with each such item, and (ii) that do not leach an undesirable level of contaminants or non-regulatory approved leachables into the contact lens, solution and/or predetermined substance. Exemplary materials for the stopper 40 are selected from the group including GLS 254-071, C-Flex R70-001, Evoprene TS 2525 4213, Evoprene SG 948 4213 and Cawiton 7193, modifications of any of the foregoing, or similar thermoplastic elastomers. As may be recognized by those or ordinary skill in the pertinent art based on the teachings herein, these materials are only exemplary, and numerous other materials that are currently known, or that later become known, equally may be used.

As may be recognized by those skilled in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from its scope as defined in the appended claims. For example, the resealable stopper may be integrally molded with the body such as by co-molding (e.g., over molding the stopper to the filling boss or vice-versa) or insert molding. Alternatively, the resealable stopper may be fused or otherwise melted to the body, or the resealable stopper may be sequentially molded to the body. In addition, the resealable stopper may be made of any of numerous different materials that are currently known, or that later become known for performing the functions of the resealable stopper described herein, such as any of numerous different thermoplastic and/or elastomeric materials, including, for example, low-density polyethylene. Similarly, the stopper may be formed with plural layers, such as an inner layer that is compatible with the contact lens solution and/or predetermined substance within the container, and an outer layer that is needle penetrable and laser resealable. The inner layer of the stopper can be made of vulcanized rubber, silicon, or any of numerous other materials that are currently known, or later become known as being compatible with, or otherwise defining a stable enclosure for the particular contact lens, contact lens solution and/or predetermined substance within the container. In addition, the sealing station may employ any of numerous different types of heat sources that are currently known, or that later become known, for performing the function of the heat sources described herein, such as any of numerous different types of laser or other optical sources or conductive heat sources. Also the contact lens, the contact lens solution or the packing solution, and the predetermined substance added to the container, can be any of numerous different types of contact lenses, solutions, and/or substances that are currently known, or that later become known. Accordingly, this detailed description of the currently preferred embodiments is to be taken in an illustrative, as opposed to a limiting sense.

1. A contact lens carrying case which is discarded once the seal on a housing area that houses contact lens is broken and the contact lens is removed from the housing area, the contact lens carrying case comprising: a contact lens case main unit that includes a housing unit comprising housing areas that include concavities arranged to house contact lenses, and including at least one cover unit that seals the lenses in the housing areas when the at least one cover unit is mounted to the housing unit; and a resealing prevention feature that prevents each housing area from being resealed by the cover units, once each housing area is no longer in a sealed state, wherein the resealing prevention feature prevents each housing area from being resealed by the cover unit by irreversibly changing the configuration of the case main unit when the sealed state is lost, wherein said irreversible change in the configuration of said case main unit is caused by the rotation of a handle component integral to the contact lens carrying case, said rotation of the handle effectuated while said cover unit remains closed thereby enabling the detachment of a portion of members comprising a part of said case main unit, said irreversible change comprising at least one of, a) detachment of the members from the at least one cover unit such that a portion of the members remain in a portion of the case main unit other than the at least one cover unit; or b) detachment of the members from the housing unit such that a portion of the members remain in a portion of the case main unit other than the housing unit.

2. The contact lens carrying case according to claim 1, wherein said irreversible change in the configuration of said case main unit includes the detachment of a part of the members comprising each of said case main unit from the cover unit or/and the housing unit.

3. The contact lens carrying case according to claim 1, wherein the part of the members that detach from said at least one cover unit remains in part of the case main unit other than the at least one cover unit.

4. The contact lens carrying case according to claim 1, wherein the part of the members that detach from said housing unit remains in part of the case main unit other than the housing unit.

5. The contact lens carrying case according to claim 1, wherein both the first housing area and the second housing area are sealed using a single cover unit.

6. The contact lens carrying case according to claim 1, wherein said at least one cover unit seals the housing area by engaging with the housing unit, and said resealing prevention feature constitutes a means for preventing the resealing of the housing area via the cover unit by irreversibly changing the configuration of at least one of the cover unit and the housing unit when the cover unit and the housing unit are no longer engaged.

7. A disposable contact lens carrying case comprising: a case main unit including a cover unit and housing areas, the housing areas having concavities arranged to house contact lenses, and the cover unit arranged so that the cover unit seals the lenses in the concavities of the housing areas when the cover unit is mounted to the housing areas; a resealing prevention feature that prevents each housing area from being resealed by the cover unit once the seal of a housing area has been broken and is no longer in a sealed state, wherein the resealing prevention feature prevents each housing area from being resealed by the cover unit by irreversibly changing the configuration of the case main unit, wherein said irreversible change in the configuration of said case main unit is caused by rotation of a handle component integral to the contact lens carrying case, said rotation of the handle effectuates the detachment of a portion of members comprising a part of said case main unit while said cover unit remains closed, said irreversible change comprising at least one of, a) detachment of the members from the cover unit such that a portion of the members remain in a portion of the case main unit other than the cover unit; or b) detachment of the members from the housing area such that a portion of the members remain in a portion of the case main unit other than the housing area.

8. The contact lens carrying case according to claim 1, wherein said housing unit includes a set of contact lenses stored therein and includes a first housing area that houses a contact lens for the left eye and a second housing area that houses a contact lens for the right eye, as said housing area.
Contact Lens Description
BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a contact lens carrying case, and more particularly to a so-called disposable-type carrying case that is discarded once the contact lenses contained therein are removed.

2. Description of the Related Art

In recent years, a so-called disposable-type carrying case has been proposed as a container for housing contact lenses. With this type of disposable-type carrying case, the interior of the case is maintained in a sterile state when new, and the case is discarded after it is used for storing or cleaning the contact lenses. When this type of carrying case is used, the contact lenses are always stored in the sterile interior of the case. Consequently, the carrying case need not be cleaned each time the contact lenses are to be stored or cleaned therein, and the contact lenses can be stored and cleaned in a clean environment.

In order to reliably prevent the user from reusing this type of disposable carrying case, it must be made impossible to seal the case once it has been opened and the contact lenses removed. Accordingly, a method has been proposed in the conventional art whereby the lens housing areas of the case interior are covered by a film, which is affixed to the case main units using an adhesive. This method employs the principle that once the film is removed, the adhesive power of the adhesive weakens due to exposure to the air, thereby preventing the lens housing areas that were covered by the film from being re-sealed. (See, for example, Japanese Patent Laid-Open 2002-142838.)

However, with the conventional method in which the case is sealed using an adhesive, the adhesive can adhere to the fingers when the user attempts to remove the contact lenses, making the case difficult to handle.

A disposable-type carrying case is sometimes marketed as a product together with so-called `disposable contact lenses` intended for only one day’s use, with the lens storage solution already present in the carrying case. In this case, a process whereby the film is affixed to the case main units must be carried out during the product manufacturing stage, and during this affixation process, in order to ensure that the contact lenses remain sealed in the case, the degree of adhesion of the film (for example, the existence of areas of the film that are not adhering to the case main units) must be monitored strictly, which is inconvenient from a manufacturing standpoint.

In addition, no design has yet been proposed for a conventional disposable-type carrying case that reliably prevents the lens housing areas from being resealed using a method other than adhesion.

Accordingly, with the foregoing in view, an object of the present invention is to resolve the problems described above and to realize, via an easy-to-use construction, a disposable-type carrying case in which the lens housing areas cannot be re-closed.

SUMMARY OF THE INVENTION

The present invention is the contact lens carrying case which is discarded, once the seal on a housing area that houses contact lens is broken and the contact lens is removed from the housing area, the contact lens carrying case comprising: a case main unit that includes a housing unit in which is formed the housing area, and a cover unit that seals the housing area by being mounted to the housing unit; and a resealing prevention means that prevents each housing area from being resealed by the cover unit, once the housing area is no longer in a sealed state, wherein the resealing means constitutes means that prevents each housing area from being resealed by the cover unit by irreversibly changing the configuration of the case main unit when the sealed state is lost.

Here, an `irreversible change` means a change that cannot be undone in order to return to the previous state.

According to the contact lens carrying case described above, the configuration of the case main unit is irreversibly changed when the sealed state of the housing areas is lost. Resealing of the housing area by the cover unit is prevented by this irreversible change. Therefore, a non-reusable disposable-type carrying case can be realized via an easy-to-handle construction, and the ease of use of the carrying case can be increased while maintaining the case interior in a hygienic state.

Such an irreversible change in the configuration of the case main unit may consist of the removal of a part of the members comprising the case main unit from the cover unit or the housing unit, or a change in the configuration of the part of the members comprising the case main unit, for example. In the first example, a construction may be adopted in which a part of the members removed from the cover unit may be left on part of the case main unit other than the cover unit, or in which the part of the members removed from the housing unit may be left on part of the case main unit other than the housing unit. Either construction would prevent the removed member from being misplaced or lost.

It is preferred that the housing unit have as housing area a first housing area that houses the contact lens for the left eye and a second housing area that houses the contact lens for the right eye. Such a construction enables a pair of contact lenses to be housed in a single case, and makes the carrying case even easier to handle.

It is also preferred, from the standpoint of ease of handling of the cover, that both the first housing area and the second housing area be sealed using a single cover unit.

It is acceptable if the cover unit seals the housing area by engaging with the housing unit, and if the resealing prevention means prevents the resealing of the housing area via the cover unit by irreversibly changing the configuration of at least one of the cover unit and the housing unit when the cover unit and the housing unit are no longer engaged.

Furthermore, a clamping unit that clamps together the housing unit and the cover unit affixed to the housing unit may be adopted as means to maintain the housing area in a sealed state, and the resealing prevention means may constitute means that prevents resealing of the housing area by irreversibly changing the configuration of the clamping unit and at least one of the cover unit and the housing unit when the clamping unit is no longer in the clamped position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an explanatory drawing showing a plan view of a contact lens case 10 constituting a first embodiment of the present invention;

FIG. 2A shows a side view of the contact lens case 10 before sealing;

FIG. 2B shows a side view of the contact lens case 10 after sealing;

FIG. 3 is a perspective view showing the components disposed around the end portions 27G and 27H of the cover unit 20B that is integrally formed with a handle 12;

FIG. 4 is a perspective view showing the components by which the cover unit 20B engages with the housing unit 50;

FIG. 5 is an explanatory drawing showing an expanded inverted view of the important components in FIG. 2A;

FIG. 6 is an explanatory drawing showing an expanded view of the important components in FIG. 2B;

FIG. 7 shows the handle 12 of the case main unit 10B in the sealed state when it is rotated in the direction of the arrow P1;

FIG. 8 shows the rotation of the handle 12 while pressure is applied to the top portions 41G and 41H;

FIG. 9 shows the state in which an engaging member 40H is detached from the end portion 27H of the cover unit 20B;

FIGS. 10A and 10B each show a side view of the contact lens case 10 constituting a second embodiment of the present invention from two different directions; and

FIG. 11 is a perspective view showing the state in which the engaging member 40H is secured at two locations on the end portion 27H via two bridges, i.e., a first bridge 29H and a second bridge 28H.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In order to further clarify the construction and operation of the present invention described above, embodiments of the present invention will be described below with reference to specific examples thereof. FIG. 1 is an explanatory drawing showing a plan view of a contact lens case 10 constituting a first embodiment of the present invention, while FIG. 2A is an explanatory drawing showing a side view of the contact lens case 10. This contact lens case 10 is a so-called disposable-type carrying case wherein the cover units 20A and 20B cannot be re-closed once they are opened from the closed state.

As shown in FIG. 1, the contact lens case 10 includes a case main unit 10A that houses the contact lens for the left eye and a case main unit 10B that houses the contact lens for the right eye. The case main units 10A and 10B share a common housing unit 50. As a result, the case main unit 10A is integrally formed with the case main unit 10B.

As shown in FIGS. 1 and 2, housing concavities 54A and 54B that constitute semi-spherical bowl-shaped concavities are formed side by side in the housing unit 50. The left contact lens and right contact lens are housed in these housing concavities 54A and 54B, respectively, together with storage solution or cleaning solution.

Covers 20A and 20B are mounted to the housing unit 50 via folding strips 90A and 90B, respectively. The letters `L` and `R` are affixed to these covers 20A and 20B, respectively, to indicate that the associated contact lens is intended for the left or right eye. The folding strip 90A and cover 20A, as well as the folding strip 90B and cover unit 20B, are integrally formed with the housing unit 50.

The cover units 20A and 20B are formed such that when they are folded over along the v-v line shown in FIG. 1 and rotated approximately 180.degree. in the direction of the arrow D1 shown in FIG. 2A, they cover the housing concavities 54A and 54B, respectively. The bent areas of the folding strips 90A and 90B are thinner than the housing unit 50.

The cover units 20A and 20B that are rotated in this fashion are fastened in the closed position by fastening mechanisms SJ described below. As a result, the housing concavities 54A and 54B are sealed (hereinafter referred to as the `sealed state`) by the cover units 20A and 20B, respectively. FIG. 2B shows the case main unit 10B in the sealed state.

While the housing concavities 54A and 54B are in the sealed state, opening the cover units 20A and 20B causes this sealed state to be broken via the breaking mechanisms TJ described below. The contact lens case 10 as to which the sealed state has been broken has a non-resealable construction in order to prevent contamination of the case due to repeated use, and is discarded after the left and right contact lenses are removed from the housing concavities 54A and 54B.

FIG. 1 shows the case main unit 10B before it has ever been used (hereinafter the `unused state`) and the case main unit 10A in the sealed state. Where both the case main unit 10A and the case main unit 10B are in the unused state, the [contact lens case 10] is formed in the configuration bisected by the t-t line in FIG. 1. Consequently, the case main units 10A and 10B have essentially the same components. Therefore, in the description of the components of the case main units 10A and 10B below, in principle the case main unit 10B will be used as a representative example. Moreover, in FIGS. 1 and 2, identical symbols will be used to indicate components that are common to both the case main unit 10A and the case main unit 10B.

As shown in FIG. 1, a protrusion 53 is formed on the housing unit 50 on the side of the case main unit 10B such that it protrudes upward relative to the inner circumferential wall of the housing concavity 54B (i.e., the direction in which the closed cover unit 20B is located relative to the housing unit 50, hereinafter referred to as `upward` or the `top`) (see FIGS. 2A and 2B). A circumferential groove 52 is formed between this protrusion 53 and the surface 51 of the housing unit 50. At the same time, a cover member 25 that faces the housing concavity 54B when the cover unit 20B is closed is formed on the cover unit 20B of the case main unit 10B, as is a protrusion 24 that protrudes downward relative to the inner circumferential wall of the cover member 20B (i.e., the direction in which the housing unit 50 is located relative to the closed cover unit 20B, hereinafter referred to as `downward` or the `bottom`). A circumferential groove 23 and protrusion 22 are formed in this order between this protrusion 24 and the surface 21 of the cover unit 20B.

Beginning from the situation shown in FIG. 2A, where the case main unit 10B is in the unused state, if the cover unit 20B is closed in the direction of the arrow D1 so as to cover the housing concavity 54B, the protrusion 24 disposed on the side of the cover unit 20B enters the interior of the housing concavity 54B along the inner circumferential wall of the housing concavity 54B. As a result, the housing concavity 54B is covered by the cover member 25. When the cover unit 20B is thereafter completely shut, the protrusion 53 disposed on the side of the housing unit 50 becomes snugly engaged with the circumferential groove 23 disposed on the outer circumference of the protrusion 24, and the protrusion 22 disposed on the side of the cover unit 20B becomes snugly engaged with the circumferential groove 52 disposed on the outer circumference of the protrusion 53. The housing concavity 54B is maintained in an airtight condition by the tight fit between the protrusions and grooves described above. When the cover units 20A and 20B are thereafter closed using the fastening mechanisms SJ composed of engaging members 40G and 40H, concave areas 55G and 55H and the like, the housing concavity 54B enters the sealed state shown in FIG. 2B.

As shown in FIGS. 1 and 2, the case main unit 10B includes a handle 12 that is integrally formed with the end portions 27G and 27H of the cover unit 20B. Fastening mechanisms SJ that maintain the closed state of the cover unit 20B and breaking mechanisms TJ that break the closed state of the cover unit 20B are disposed in the regions around the handle 12 and the end portions 27G and 27H (the regions G1 and H1 shown in FIG. 1) and the regions on the side of the housing unit 50 facing the end portions 27G and 27H of the closed cover unit 20B (the regions G2 and H2 shown in FIG. 1).

The fastening mechanisms SJ and breaking mechanisms TJ are disposed at two locations, i.e., on the inside (the areas G1 and G2 in FIG. 1, on the side nearer to the other case main unit 10A) and the outside (the areas H1 and H2 in FIG. 1, on the side farther from the other case main unit 10A). In this embodiment, the constituent parts of the fastening mechanism SJ and the breaking mechanism TJ that are disposed on the former side (the inside) are indicated by the symbol `G` at the end, while the constituent parts of the fastening mechanism SJ and the breaking mechanism TJ that are disposed on the latter side (the outside) are indicated by the symbol `H` at the end. The fastening mechanisms SJ and breaking mechanisms TJ disposed at the two different locations have essentially the same constructions and functions. Therefore, in the description below, in principle the fastening mechanism SJ and breaking mechanism TJ disposed on the outside of the case main unit 10B will be described as representative examples.

The various constituent parts of the fastening mechanism SJ and the breaking mechanism TJ will be described with reference to FIGS. 3 and 4. FIG. 3 is an explanatory drawing showing a perspective view of the components disposed around the end portions 27G and 27H of the cover unit 20B with which the handle 12 is integrally formed, while FIG. 4 is an explanatory drawing showing a perspective view of the components by which the cover unit 20B is fastened to the housing unit 50. In FIG. 4, the fastening components are shown with the handle 12 of the cover unit 10B removed in order to make the construction of such components easier to understand.

As shown in FIG. 3, openings 26G and 26H are formed in the end portions 27G and 27H of the cover unit 20B, and engaging members 40G and 40H are disposed inside these openings 26G and 26H, respectively. These engaging members 40G and 40H are composed of top portions 41G and 41H and bottom portions 45G and 45H.

The top surfaces 42G and 42H of the top portions 41G and 41H protrude upward above the end portions 27G and 27H. The top surfaces 42G and 42H slant downward so as to face in the direction of the handle 12.

The top portions 41G and 41H are fixed via first bridges 29G and 29H to the inner circumferential walls of the end portions 27G and 27H in which the openings 26G and 26H are formed.

The bottom portions 45G and 45H have an external configuration that is slightly larger than that of the top portions 41G and 41H, and extend downward from the bottom surfaces of the top portions 41G and 41H. The bottom portions 45G and 45H are each divided into two members, i.e., an inner side (the side closer to the surface 21 of the cover unit 20B) and an outer side (the side farther from the surface 21 of the cover unit 20B), by slits 47G and 47H formed in the center thereof, and engaging pieces 46G and 46H are formed on the inner side members.

As shown in FIGS. 3 and 4, an outer notch 30H and an inner notch 31H are formed on the end portion 27H disposed between the engaging member 40H and the handle 12 by eliminating sections of the top surface thereof. These notches 30H and 31H are formed along an axial line parallel to the axis of rotation of the handle 12. In addition, an outer notch 30G and inner notch 31G similar to the notches described above are formed in the end portion 27G disposed between the engaging member 40G and the handle 12.

As shown in FIG. 4, concave areas 55G and 55H are disposed at positions on the housing unit 50 that face the bottom portions 45G and 45H when the cover unit 20B is closed. These concave areas 55G and 55H are large enough to house the bottom portions 45G and 45H. Furthermore, through-holes 57G and 57H that are large enough to permit engagement with the engaging pieces 46G and 46H are formed on the inner sides of the concave areas 55G and 55H (the side of each that is nearer to the other concave area 55H or 55G). In addition, slopes 59G and 59H are formed in the concave areas 55G and 55H at positions at which they face the engaging pieces 46G and 46H when the cover unit 20B is closed.

The construction of the handle 12 will now be explained with reference to FIGS. 3 and 5. FIG. 5 is an explanatory drawing showing an enlarged view of the important components Y1 in FIG. 2A rotated 180.degree. vertically. As shown in these figures, when the handle 12 is mounted to the end portions 27G and 27H, the top surfaces 13G and 13H are higher than the top surfaces 42G and 42H of the engaging members 40G and 40H. The height of these top surfaces 13G and 13H is set at the height at which the walls 14G and 14H that face the engaging members 40G and 40H come into contact with the top surfaces 42G and 42H when the handle 12 rotates in the direction of the engaging members 40G and 40H around an axis consisting of the line that connects the outer notches 30G and 30H and the inner notches 31G and 31H of the end portions 27G and 27H.

In the contact lens case 10 having the construction described above, the fastening mechanisms SJ are composed of the engaging members 40G and 40H disposed on the side of the cover unit 20B and the concave areas 55G and 55H having the through-holes 57G and 57H that are disposed on the side of the housing unit 50. In other words, when the cover unit 20B is closed, the bottom portions 45G and 45H of the engaging members 40G and 40H disposed on the side of the cover unit 20B enter the concave areas 55G and 55H on the side of the housing unit 50. When this occurs, because the engaging pieces 46G and 46H that come into contact with the slopes 59G and 59H are guided by the slanted surfaces thereof to enter the concave areas 55G and 55H, they are smoothly and reliably led toward the interior of the concave areas 55G and 55H. When the cover unit 20B is then closed, the engaging pieces 46G and 46H advance toward the bottom surfaces of the concave areas 55G and 55H while warping toward the slits 47G and 47H due to the contact with the inner walls 56G and 56H, and enter the through-holes 57G and 57H due to elastic force at the time that they reach the positions at which the through-holes 57G and 57H are formed. This causes the engaging pieces 40G and 40H on the side of the cover unit 20B to engage with the concave areas 55G and 55H on the side of the housing unit 50, maintaining the cover unit 20B in the closed state. This engaged state is shown in FIG. 6. FIG. 6 shows an enlarged view of the key components Y2 in FIG. 2B. In addition, when the cover unit 20B is in the closed state, a sufficient clearance is maintained after engagement between the bottommost parts of the bottom portions 45G and 45H and the inner bottom surfaces of the concave areas 55G and 55H.

At the same time, the breaking mechanisms TJ are composed of engaging members 40G and 40H that are engaged with the concave areas 55G and 55H, end portions 27G and 27H that are connected to these engaging members 40G and 40H via first bridges 29G and 29H, and the handle 12. The functions of these various components are explained with reference to FIGS. 6 through 9.

In the state shown in FIG. 6 (the state in which the engaging members 40G and 40H are engaged with the concave areas 55G and 55H), when the handle 12 is lifted upward in the clockwise direction, the handle 12 rotates in the direction of the arrow P1 around an axis consisting of the line that connects the outer notches 30G and 30H and the inner notches 31G and 31H of the end portions 27G and 27H, as shown in FIG. 7. As a result of this rotation of the handle 12, the first bridges 29G and 20H that link the end portions 27G and 27H with the top portions 41G and 41H of the engaging members 40G and 40H is pulled upward in the direction of rotation of the handle 12, and the walls 14G and 14H of the handle 12 come into contact with the foot areas (the bottommost portions of the downward slanting surfaces) of the top surfaces 42G and 42H of the engaging members 40G and 40H.

In FIGS. 6 through 9, because the outer notch 30G and the inner notches 31G and 31H are positioned directly behind the outer notch 30H, they are omitted from the figures. Furthermore, in FIGS. 6 through 8, the hollowed-out area formed in the outer notch 30H is indicated by diagonal lines.

In the state shown in FIG. 7 (the state in which the top surfaces 42G and 42H are in contact with the walls 14G and 14H), when the handle 12 is further lifted upward in the clockwise direction, the handle 12 rotates in the direction of the arrow P1 while pressing diagonally downward in the direction opposite from the handle 12 (in the direction of the arrow Q1 in FIG. 7) against the top portions 41G and 41H of the engaging members 40G and 40H via the walls 14G and 14H.

The rotation of the handle 12 while pressure is applied against the top portions 41G and 41H is shown in FIG. 8. As shown in FIG. 8, the diagonal downward pressure on the top portions 41G and 41H causes the engaging members 40G and 40H to move downward (in the direction of the arrow R1 in FIG. within the concave areas 55G and 55H, whereby the bottommost parts of the bottom portions 45G and 45H come into contact with the inner bottom surfaces of the concave areas 55G and 55H. As a result, the engaging members 40G and 40H can no longer move within the concave areas 55G and 55H in the direction of the arrow R1.

In addition, the diagonal downward pressure exerted on the top portions 41G and 41H causes the engaging members 40G and 40H to move horizontally within the openings 26G and 26H of the end portions 27G and 27H in the direction away from the handle 12 (in the direction of the arrow S1 in FIG. 8), whereby the top portions 41G and 41H of the engaging members 40G and 40H come into contact with the end portions 27G and 27H on the side at which the first bridges 29G and 29H are not formed. As a result, the engaging members 40G and 40H can no longer move in the direction of the arrow S1 within the openings 26G and 26H.

The rotation of the handle 12 that results in this movement of the engaging members 40G and 40H further causes the first bridges 29G and 29H to be lifted upward in the direction of rotation of the handle 12.

During the state shown in FIG. 8 (the state in which the engaging members 40G and 40H cannot move in the direction of the arrows R1 and S1), if the handle 12 is pulled upward in the clockwise direction with force, the handle 12 rotates in the direction of the arrow P2 using as a fulcrum the contact point `fu` disposed between the walls 14G and 14H and the top surfaces 42G and 42H. This rotation of the handle 12 in the direction of the arrow P2 while the engaging members 40G and 40H are fixed in position causes the end portions 27G and 27H that are integrally formed with the handle 12 to rise gradually starting with the parts close to the handle 12. As a result, the first bridges 29G and 29H connected to the parts of the end portions 27G and 27H that are close to the handle 12 are pulled with force in the direction of the arrow P2 while the connection with the top portions 41G and 41H is maintained, resulting in the application of a shearing force to the first bridges 29G and 29H. This shearing force increases in strength as the rotation of the handle 12 in the direction of the arrow P2 progresses, and within a short amount of time the first bridges 29G and 29H are sheared off from the end portions 27G and 27H.

Due to the shearing of the first bridges 29G and 29H, the cover unit 20B detaches from the engaging members 40G and 40H. As a result, the handle 12 can be further rotated in the direction of the arrow P2 and the cover unit 20B can be opened, thereby allowing the contact lenses to be removed from the housing concavities 54A and 54B.

The detachment of the engaging member 40H from the cover unit 20B is shown in FIG. 9. As shown in FIG. 9, the first bridge 29H connected to the end portion 27H of the cover unit 20B is sheared off at the region X. The engaging member 40H that is detached from the cover unit 20B due to this shearing is held on the side of the housing unit 50 while engaging with the concave area 55H. The first bridge 29H remains on the surface of this held engaging member 40H after shearing occurs. As a result of the shearing of the first bridge 29H as described above, the cover unit 20B cannot be returned to its original configuration (i.e., its configuration when the engaging member 40H was connected to the end portion 27H).

Even where the cover unit 20B is closed from the state shown in FIG. 9 (the state in which the engaging member 40H has detached from the end portion 27H of the cover unit 20B), because there is no member that keeps the cover unit 20B fastened to the housing unit 50 (i.e., the engaging member 40H), the cover unit 20B cannot be maintained in the closed state. As a result, the housing concavity 54B can no longer be resealed by the cover unit 20B.

According to the contact lens case 10 of the first embodiment described above, where the sealed state of the housing concavity 54B realized via the closing of the cover unit 20B is broken by the opening of the cover unit 20B, the engaging members 40G and 40H detach from the cover unit 20B due to the breaking of this sealed state. The resealing of the housing concavity 54B by the cover unit 20B is prevented by the detachment of the engaging members 40G and 40H. Therefore, a non-reusable disposable-type carrying case can be realized via an easier-to-handle construction, and the convenience of the carrying case can be increased while maintaining the cleanliness of the carrying case. Furthermore, because the engaging members 40G and 40H that detach from the cover unit 20B remain inside the concave areas 55G and 55H of the housing unit 50, they can be prevented from becoming separated from the contact lens case 10 after they detach.

Moreover, according to the above contact lens case 10, the contact lenses that are inserted in the user’s eyes can be stored in a safer condition. In other words, first, using the contact lens case 10 described above, the fastening mechanisms SJ disposed on the case main unit 10B are lost due to the opening of the cover unit 20B from the closed state. As a result, the user can readily determine from the state of the case main unit 10B after the cover unit 20B is opened (specifically, the state in which the cover unit 20B cannot be maintained in a closed state after it is opened) that the cover unit 10B cannot be reused. Therefore, a situation in which the case is mistakenly reused and the contact lenses are contaminated by microbes or the like can be reliably prevented.

Second, using the above contact lens case 10, it can be clearly seen based on the appearance of the case main unit 10B that the cover main unit 20B has been opened from the closed state. This is because due to the opening of the cover unit 10B from the closed state, the configuration of [the case main unit 10B] changes as a result of the detachment of the engaging members 40G and 40H from the cover unit 20B, thereby preventing the case main unit 10B from being returned to its state prior to the opening of the cover 20B. Therefore, the intentional insertion of foreign matter into the case main unit 10B in which the contact lens is housed can be prevented.

A different construction that combines cleanliness, convenience and safety as described above will be described below as a second embodiment. FIG. 10A is an explanatory drawing showing the side view of a contact lens case 110 constituting a second embodiment of the present invention. The contact lens case 110 shown in FIG. 10 includes essentially the same components as the contact lens case 10 of the first embodiment described above. In FIG. 10, these common components are indicated using in the tens and ones columns the same numbers and letters used in connection with the first embodiment above.

FIG. 10A is a side view equivalent to FIG. 2B, and shows case main units 110A and 110B in the state in which housing concavities 154A and 154B are sealed by cover units 120A and 120B that are bent via folding strips 190A and 190B. Because the folding strip 190A, cover unit 120A, housing concavity 154A and case main unit 110A are disposed behind the folding strip 190B, cover unit 120B, housing concavity 154B and case main unit 110B, they are not shown in the drawing. FIG. 10B is a side view of the folding strip 190B of the case main unit 110B shown in FIG. 10A as seen from the direction of the arrow W.

The contact lens case 110 of the second embodiment has, as in the first embodiment, fastening mechanisms SJ comprising the engaging members 140G and 140H that are disposed on the side of the cover unit 120B and engage inside the concavities 155G and 155H that are disposed on the side of the housing unit 50, such fastening mechanisms SH holding the cover unit 120B in the closed position. At the same time, the contact lens case 110 differs from the contact lens case 10 of the first embodiment in that the breaking mechanisms TJ that break the closed state of the cover units 120A and 120B are disposed on the folding strips 190A and 190B. In other words, as shown in FIG. 10B, a cutaway area 191 formed by notches on either side, as well as a pull tab 192 that is connected to this cutaway area 191 and is exposed to the outside of the case main unit 110B, are formed on the folding strip 190B of the case main unit 110B.

A V-shaped cutout 195B is cut out from the surface of the cover unit 120B near the engaging members 140G and 140H. This cutout 195B is cut out to form an obtuse angle such that its sides are parallel with the line connecting the engaging member 140G and the engaging member 140H, and is formed along the entire outer surface of the cover unit 120B. Similarly, a cutaway area, pull tab and cutout similar to those in the case main unit 110B are also formed in the folding strip 190A of the case main unit 110A and the cover unit 120A.

In the contact lens case 110 having the above construction, the cover units 120A and 120B are not opened from the side of the fastening mechanisms SJ, but from the side of the folding strips 190A and 190B. In other words, by pulling the pull tab 192 along the notches of the cutaway area 191, the cutaway area 191 is torn away from the folding strip 190B, causing the pull tab 192 and the cutaway area 191 to detach from the folding strip 190B. This permits the cover unit 120B to be opened in the direction of the arrow K1 shown in FIG. 10A using the cutout 195B as a rotational axis, allowing the contact lens to be removed from the housing concavity 154B.

In addition, the detachment of the pull tab 192 and the cutaway area 191 prevents the folding strip 190B from returning to its original configuration. Therefore, even where the cover unit 120B is closed after the detachment of the pull tab 192 and the cutaway area 191, the cover unit 120B cannot be maintained in the closed state, and consequently the housing concavity 154B cannot be resealed by the cover unit 120B.

According to the contact lens case 110 of the second embodiment described above, when the sealed state of the housing concavity 154B achieved via the closing of the cover unit 120B is broken, the pull tab 192 and the cutaway area 191 detach from the folding strip 190B as a result thereof. The detachment of the cutaway area 191 prevents the resealing of the housing concavity 154B by the cover unit 120B. Therefore, a non-reusable disposable-type carrying case can be realized using a construction that is easier to handle, and the convenience of the carrying case can be increased while maintaining the cleanliness thereof. Furthermore, as with the contact lens case 10 of the first embodiment described above, the contact lenses that are inserted in the user’s eyes can be stored in a safer condition.

In the second embodiment described above, a construction having no handles 112 may be adopted, and it is acceptable if a different construction for the fastening mechanisms SJ is used.

While the present invention was explained with reference to embodiments, the present invention is not limited thereby, and may be implemented in any fashion within the essential scope of the invention. For example, the first embodiment used the construction in which the engaging members 40G and 40H remain in the concave areas 55G and 55H after detachment, but a construction in which the engaging members 40G and 40H do not remain in the case main units 10A and 10B after detachment may be adopted instead.

In the above embodiments, the engaging members 40G and 40H were secured to the end portions 27G and 27H of the cover units 20A and 20B at a single location via the first bridges 29G and 29H, but they may be secured at two or more locations. An example in which the engaging member 40H is secured to the end portion 27H at two locations via a first bridge 29H and a second bridge 28H is shown in FIG. 11.

In the above embodiments, the engaging members 40G and 40H were disposed on the side of the cover units 20A and 20B, while the concave areas 55G and 55H were disposed on the side of the housing unit 50, but a construction may be adopted instead wherein the engaging members 40G and 40H are disposed on the side of the housing unit 50, while the housing concavities 54A and 54B are disposed on the side of the cover units 20A and 20B.

In the above embodiments, the case main unit 10A including the housing concavity 54A was integrally formed with the case main unit 10A including the housing concavity 54B, and the right and left contact lenses were housed as a pair in the contact lens case 10, but it is acceptable if a construction is adopted wherein the case main units 10A and 10B are separate, and the right and left contact lenses are housed in separate cases.

In the above embodiments, the housing concavities 54A and 54B were covered by two separate cover units 20A and 20B, but a construction may be adopted wherein both housing concavities 54A and 54B are covered by a single cover unit.

Furthermore, while the cover units 20A and 20B are integrally formed with the housing unit 50 in the above embodiments, a construction may be used wherein the cover units 20A and 20B are separate from the housing unit 50 and are mounted thereon in an interlocking fashion.

In the above embodiments, a handle 12 was used as means to break the fastening of the cover units 20A and 20B to the housing unit 50, but a construction may be adopted that does not use handles 12, but wherein the fastening of the cover units 20A and 20B is broken using a finger or nail. For example, in the case of the first embodiment described above, if a finger is inserted between the cover units 20A and 20B and the housing unit 50 of the contact lens case 10 during the closed state, and the end portions 27G and 27H of the cover units 20A and 20B are lifted upward, the engaging members 40G and 40H become detached from the cover units 20A and 20B and the cover units 20A and 20B can be opened.

In the above embodiments, non-resealable contact lens cases 10 and 110 were realized via the detachment of the engaging members 40G and 40H or the cutaway area 191, but a different type of irreversible change other than detachment may be used instead. For example, a construction may be adopted wherein the opening of the cover units 20A and 20B from the sealed state over the case main units 10A and 10B causes part of the case main units 10A and 10B to deform into a configuration that prevents resealing.

In the above embodiments, non-resealable contact lens cases 10 and 110 were realized via an irreversible change in the configuration of the cover units 20A and 20B or the folding strips 190A and 190B, but a non-resealable contact lens case may also be achieved via an irreversible change in the configuration of a part of the case main units 10A and 10B other than the cover units 20A and 20B or the folding strips 190A and 190B.

For example, in the first embodiment, it is acceptable if a construction is used for the fastening mechanisms SJ wherein, instead of the engaging members 40G and 40H and the concave areas 55G and 55H, engaging members belonging to the handles 12 become engaged with the housing unit 50 to keep the cover units 20A and 20B in the closed state, such that the engaging members of the handles 12 become detached from the handles 12 when the cover units 20A and 20B are opened.

In addition, it is also acceptable if a construction is used for the fastening mechanisms SJ wherein, instead of the engaging members 40G and 40H and the concave areas 55G and 55H, clamping units that clamp the housing unit 50 and the cover units 20A and 20B together are used to keep the cover units 20A and 20B in the closed state, such that when the clamping by the clamping units is eliminated, the configuration of the housing unit 50 or of the cover units 20A and 20B, which were clamped by the clamping units, changes due to partial detachment or deformation, thereby disabling re-clamping by the clamping units.

1. A contact lens package, comprising a base member comprising a hydrophobic material and having a bottom surface and a sidewall contacting the bottom surface to form a cavity; a liquid medium located in the cavity; and a silicone hydrogel contact lens without a surface treatment, having an advancing contact angle of less than 66.degree. and located in the liquid medium, the silicone hydrogel contact lens comprising a material effective in reducing the tendency for the lens to stick to the bottom surface of the cavity without requiring an anti-attachment agent selected from the group consisting of a surfactant, a surface modification of the bottom surface, and a combination of a surfactant and a surface modification of the bottom surface, to reduce the tendency of the lens to stick to the bottom surface.

2. The package of claim 1, wherein the hydrophobic material comprises a polyolefin polymeric material.

3. The package of claim 1, wherein the hydrophobic material comprises a polypropylene material.

4. The package of claim 1, wherein the base member is a molded polypropylene element.

5. The package of claim 1, wherein the base member further comprises a flange extending from the cavity.

6. The package of claim 1, wherein the sidewall comprises at least one planar surface and at least one curved surface, each surface substantially perpendicularly oriented to the bottom surface of the cavity.

7. The package of claim 1, wherein the sidewall is oriented at a non-perpendicular angle to the bottom surface.

8. The package of claim 1, wherein the bottom surface is devoid of a ridge or a groove.

9. The package of claim 1, wherein the bottom surface has a planar surface topography.

10. The package of claim 1, wherein the liquid medium comprises saline.

11. The package of claim 1, wherein the liquid medium comprises a phosphate buffer.

12. The package of claim 1, wherein the liquid medium is free of surfactant.

13. The package of claim 1, wherein the liquid medium comprises an amount of a surfactant effective in enhancing the wettability of the contact lens.

14. The package of claim 1, further comprising a seal attached to the base member to maintain the liquid medium in a sterile condition.

15. The package of claim 1, wherein the silicone hydrogel contact lens has an advancing contact angle of less than 60.degree..

16. The package of claim 1, wherein the silicone hydrogel contact lens has a hysteresis less than about 18.degree..

17. The package of claim 1, wherein the silicone hydrogel contact lens has a hysteresis less than about 15.degree..

18. The package of claim 1, wherein the silicone hydrogel contact lens has a hysteresis less than about 10.degree..

19. The package of claim 1, wherein the silicone hydrogel contact lens has a hysteresis about 5.degree. or less.
Contact Lens Description
The present invention relates to contact lenses and more specifically relates to packages, such as blister packs, for containing at least one contact lens.

BACKGROUND

The packaging of hydrophilic contact lenses in a sterile aqueous solution is well known in the contact lens manufacturing technology. In particular, such packaging arrangements generally consist of so-called blister packages which are employed for the storage and dispensing of hydrophilic contact lenses by a medical practitioner or a consumer who intends to wear the contact lenses. Generally, such hydrophilic contact lenses, which may be disposable after a single wear or short-term use, are manufactured from suitable hydrophilic polymeric materials, such as hydroxyethyl methacrylate (HEMA). Generally, such contact lenses must be stored in a sterile aqueous solution, usually in isotonic saline solution in order to prevent dehydration and to maintain the lenses in a ready-to-wear condition.

Heretofore, contact lens manufacturers normally utilized stoppered glass bottles containing sterile saline solutions in which the hydrophilic contact lenses were immersed. Each bottle was sealed with a suitable silicone stopper and provided with a metal closure as a safety seal in the configuration of an overcap. When the contact lens was intended to be removed from the bottle for use by a patient, the metal closure safety seal was required to be initially torn off the bottle, thereafter the stopper withdrawn and the lens lifted out from the bottle through the intermediary by a suitable tweezer or by pouring the contents from the bottle. This entailed the implementation of an extremely complicated procedure, since the contact lens was difficult to grasp and remove from the saline solution contained in the bottle due to the transparent nature of the contact lens which rendered it practically invisible to the human eye.

More recently, containments in the form of blister packages have been developed for hydrophilic contact lenses, and which enable the storage and shipping of the hydrophilic contact lenses in a simple and inexpensive expedient manner, while concurrently facilitating the removal of the contact lens by a practitioner or a patient.

For instance, a blister package which is adapted to provide a sterile sealed storage environment for a disposable or single-use hydrophilic contact lens, wherein the lens is immersed in a sterile aqueous solution, for example, such as in an isotonic saline solution, is described in Martinez, U.S. Pat. No. 4,691,820. Additional contact lens packages are disclosed in U.S. Pat. Nos. 4,691,820; 5,054,610; 5,337,888; 5,375,698; 5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,620,088; 5,695,049; 5,697,495; 5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327; 5,704,468; 5,983,608; 6,029,808; 6,044,966; and 6,401,915.

Contact lens packages are typically formed from hydrophobic packaging materials, such as polypropylene, polyethylene, nylons, olefin co-polymers, acrylics, rubbers, urethanes, polycarbonates, and fluorocarbons.

Silicone hydrogel contact lenses (i.e., contact lenses which comprise a silicone hydrogel material or a hydrophilic silicon containing polymer) can be stored in packages formed of hydrophobic packaging materials. However, since silicone hydrogel contact lenses are typically made of hydrophobic materials, the contact lens will often stick or adhere to the packaging material when a surface of the contact lens and a surface of the packaging material contact. The sticking of the silicone hydrogel contact lens to the package causes many problems, including an increased chance that the lens will tear when removed from the package.

To attempt to reduce the tendency for silicone hydrogel contact lenses to stick to hydrophobic packaging materials, surfactants have been added to the contact lens packaging solution, see U.S. Patent Pub. No. 2005/0171232. Not all surfactants achieve the desired reduced tendency to stick, and some surfactants do not dissolve completely in the lens packaging solution and/or distort certain properties of the lenses.

Another attempt at reducing the tendency for silicone hydrogel contact lenses to stick to hydrophobic packaging materials is to physically or structurally alter the bottom surface of the package cavity. For example, certain packages have been produced that comprise one or more ridges or one or more grooves on the bottom surface of the cavity.

Thus, there remains a need for improved contact lens packages, particularly, contact lens packages that are suitable for storage of lenses, for example, silicon-containing polymeric contact lenses.

SUMMARY OF THE INVENTION

The present invention addresses this need. It has been discovered that the present contact lenses and contact lens packages which comprise a hydrophobic material have a reduced tendency to stick together relative to other silicone hydrogel contact lenses in similar hydrophobic packaging materials. In particular, the present packages and silicone hydrogel contact lenses do not require a surfactant or a surface modification to reduce the tendency of the lens to stick to a surface of the package. Thus, the present packages provide multiple benefits compared to existing packages, such as reduced manufacturing efforts by eliminating the need to provide surface contours on the bottom surface of the contact lens package cavity, and the potential for reduced amounts of surfactant present in the liquid medium containing the contact lens.

In one embodiment, a contact lens package comprises a base member; a liquid medium; and a silicone hydrogel contact lens. In this embodiment, the base member comprises a hydrophobic material and has a bottom surface and a sidewall contacting the bottom surface to form a cavity. The liquid medium is located in the cavity. The silicone hydrogel contact lens is located in the liquid medium. The silicone hydrogel contact lens comprises a material effective in reducing the tendency for the lens to stick to the bottom surface of the cavity without requiring an anti-attachment agent selected from the group consisting of a surfactant, a surface modification of the bottom surface, and a combination thereof, to reduce the tendency of the lens to stick to the bottom surface. The lens and package can be formed from a variety of materials as desired, and the package may have additional elements, as disclosed herein.

In another embodiment, a holder for a contact lens is provided. The holder generally comprises a base member comprising a cavity having an opening and sized to contain a contact lens in contact with, for example immersed in, a liquid medium, for example a sterile solution. The base member further comprises a flange region including a first flange surface at least partially surrounding the opening of the cavity and a substantially opposing second flange surface. The base member further comprises a grip region spaced apart from the cavity opening and including a first grip surface and a substantially opposing second grip surface.

In one such embodiment, the first grip surface extends away from the cavity opening at an angle, for example, to define a continuous curved angle away from the cavity opening. Preferably, the first grip surface extends away from the cavity opening at an angle of greater than 0.degree. and less than 90.degree. relative to a plane containing the cavity opening. Even more preferably, the first grip surface extends away from the flange region at an angle of between about 10.degree. or about 20.degree. or about 30.degree. and about 60.degree., or about 70.degree. of about 80.degree. relative to a plane containing the cavity opening. For example, the first grip surface extends away from the cavity opening at an angle of about 45.degree. relative to a plane containing the cavity opening.

The first grip surface may be a curved surface. For example, the first grip surface may be concave along a major portion of the surface. In some embodiments, the first flange surface is substantially flat and the first grip surface is a curved surface substantially directly adjacent the first flange surface. The first grip surface is located in a recessed position with respect to the first flange surface. The first grip surface may have a contoured shape substantially complementary to the shape of a surface of a human thumb, for example a surface of a tip portion of an adult human thumb. For example, the first grip surface is at least partially defined by a generally spherical surface region. In some embodiments, the first grip surface is defined substantially entirely by a curved surface, for example a surface that is curved in two directions. The first grip surface may be a concave surface.

In some embodiments, the grip region further comprises a second grip surface substantially opposing the first grip surface. Preferably the second grip surface is curved, for example, is convex.

The second grip surface may include a contoured shape substantially complementary to and/or conforming to the first grip surface.

The grip region may further comprise at least one ridge raised from the first grip surface and having a curved length. The grip region may further comprise at least one ridge raised from the second grip surface and having a curved length. The raised ridge of the first grip surface may substantially oppose the raised ridge of the second grip surface.

In one embodiment, the holder is structured and shaped to facilitate comfortable, natural, firm gripping of the holder by a thumb and forefinger of a contact lens wearer. In this embodiment, the first grip surface, which is located on a top side of the grip region, is defined by a concavely curved surface shaped to comfortably accommodate a tip region of a thumb of a human hand. The first grip surface includes embossed or raised portions, for example, one or more ridges, for facilitating manual gripping of the holder. The second grip surface, which is located on an underside of the grip region, opposite the first grip surface, is defined by a convexly curved surface shaped to comfortably accommodate a surface of a crooked or curved forefinger of the same human hand. In this embodiment, the second grip surface is spaced apart from the second surface of the cavity so as to allow sufficient area for placement of the curved human forefinger therebetween. The second grip surface also includes embossed or raised portions, for example, one or more ridges, for facilitating gripping. The raised surfaces on the first grip surface and the raised surfaces on the second grip surface may comprise raised segments having curved lengths.

The base member further comprises a peripheral ridge located at an outer edge of the flange region. The peripheral ridge extends substantially perpendicular to the first flange surface.

In some embodiments, the cavity includes a substantially flat or planar bottom surface which is circumscribed by a curved side surface. The curved side surface may be defined by a generally spherical surface region. In one aspect of the invention, the cavity is contoured to enable a contact lens wearer to remove a contact lens from the cavity by means of the wearer’s fingertip, for example, when the cavity is approached from substantially any rotational angle. For example, the curved region is defined by a uniformly sloped, generally frusto spherical, surface region. For example, the cavity may be somewhat dome shaped, with a flattened bottom surface. Preferably, the curved side surface is defined by a substantially uniform radius of curvature about the generally planar surface region. The cavity is preferably substantially entirely defined by the generally planar region and a generally frusto spherical surface region.

In some embodiments, at least a portion of the cavity surface is textured. The texture is effective to inhibit adherence of the contact lens to the surface of the generally planar region. For example, in one embodiment, the curved side surface of the cavity is smooth relative to the bottom surface of the cavity which is textured. In some embodiments, the planar bottom surface includes a finely ridged or grooved, for example, striated textured surface. As discussed herein, these features may not be required in silicone hydrogel contact lenses that are formed of a material that is effective in reducing the tendency of the silicone hydrogel lens to stick to the surface of the cavity.

The present packages further provide such a holder as described elsewhere herein which includes a contact lens immersed in liquid medium, and a cover assembly secured to the flange region to sealingly close the cavity having the contact lens and liquid medium therein. In some embodiments, the cover assembly comprises a first member sealingly enclosing the cavity and a second member secured to the base member and at least partially covering the first member. For example, in one embodiment, the cover assembly includes a first member sealingly covering the cavity but not the first grip surface and a second member covering the first member and at least a portion of the first grip surface, for example, the entirety of the first grip surface.

In another aspect, the cavity is sized and shaped to accommodate a single contact lens immersed in solution, and is sized and shaped to facilitate removal of the contact lens from the cavity. The cavity is preferably structured to accommodate a lens in a free floating position within the cavity and solution. By “free floating” is meant that the contact lens moves freely in the solution without significantly adhering to surfaces of the cavity.

In yet another aspect, the cover assembly comprises a first member sealingly enclosing the cavity. In another embodiment, the cover assembly comprises the first member sealingly enclosing the cavity and a second member secured to the base member and at least partially covering the first member. The second member may be removably attached to the base member so as to provide a protective, sanitary cover over both the grip surface region and the first member in order to maintain sterility of these features of the invention. In some embodiments, the first cover member is smaller in size than the second cover member. For example, while the first cover member is sized to overlay and seal the cavity opening, the second cover member is sized to overlay and seal the entire upper surface of the base member, including the cavity, the peripheral region and the grip surface region.

Each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present invention provided that the features included in such a combination are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded from any embodiment of the present invention.

These and other aspects of the present invention are apparent in the following detailed description and additional disclosure, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a contact lens package comprising a base member and a sealing assembly, in accordance with an embodiment of the present invention.

FIG. 2 is a perspective view of the contact lens package shown in FIG. 1, the package now being shown with the sealing assembly removed from the base member.

FIG. 3 is a cross sectional view of the base member shown in FIG. 2 taken along lines 3-3.

FIG. 3A is a perspective view of the contact lens package shown in FIG. 2, the package shown being gripped between a tip of a human thumb and a crooked forefinger.

FIG. 3B is a perspective view of a prior art contact lens package.

FIG. 4 shows the contact lens package shown in FIG. 1, the package now being shown with a portion of a second element of the sealing assembly cut away from the base member, thereby revealing an underlying first element of the sealing assembly.

FIG. 5 is a perspective view of another prior art contact lens package.

FIG. 6 is a perspective view of a contact lens package including a silicone hydrogel contact lens in a cavity of the lens package body, in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION

Turning now to FIG. 1, a contact lens package, in accordance with the present invention, is shown generally at 10.

The package generally comprises a base member 12 and a cover assembly 14. The invention will be more clearly understood and appreciated with reference to FIG. 2 which shows the package 10 shown in FIG. 1 with the cover assembly 14 removed from the base member 12. As shown, the base member 12 includes a cavity 18 for containing a contact lens (not shown) immersed in an amount of a solution. The term “contact lens” as used herein is intended to embrace an ophthalmic lens which, after its removal from a mold assembly in which it is made, is of a structure, size, shape and power that it can be worn on or in the eye of an individual. The base member 12 further includes a peripherally located flange region 20 at least partially surrounding an opening of the cavity 18, and a grip region 22 which is recessed with respect to the flange region 20. The cover assembly 12 sealingly encloses the contact lens and solution within the cavity 18.

The base member 12 is preferably formed of a plastic material which can be formed by injection molding or thermoforming. The plastic material used to make the base member is preferably polypropylene, but can comprise other similar plastic materials, such as, other polyalkylenes, e.g. polyethylene, and polybutylene; polyesters, e.g. PET; polycarbonates; or other thermoplastic materials. In certain embodiments, one or more portions of the base material, particularly in the cavity 18, has a vapor transmission of less than 10 grams/100 square inches/24 hours at 70.degree. F. and 50 percent relative humidity.

One material for forming the base member 12 is a polypropylene homopolymer, for example Polypropylene PPH 10042, which is a nucleated antistatic homopolymer with a high melt flow index of 35 g/10 min. Polypropylene PPH 10042 is marketed by and available through Atofina Petrochemicals or Total Petrochemicals. Thus, the present contact lens packages may comprise a base member 12 formed of a hydrophobic material, such as polypropylene. In certain embodiment, the base member 12 comprises a polypropylene homopolymer having a melt flow index of about 35 g/10 min, a tensile strength at yield of 35 Mpa, an elongation at yield of about 8.5%, and/or a tensile modulus of about 1700 mPA, as determined using the ISO 527-2 method. The present material may also have a flexural modulus of about 1600 mPA as determined using the ISO 178 method, an Izod impact strength (notched) at 23.degree. C. of about 3 kJ/m.sup.2 using the ISO 180 method, a Charpy impact strength at 23.degree. C. (notched) of about 3.5 kJ/m.sup.2 using the ISO 179 method, and/or a Rockwell hardness (R-scale) of about 98 using the ISO-2039-2 method. The present materials may also have a melting point of about 165.degree. C. using the ISO 3146 method, a density of about 0.905 g/cm.sup.3, and/or bulk density of about 0.525 g/cm.sup.3 using the ISO 1183 method.

The flange region 20 is preferably contiguous to the circumference of the cavity 18. The flange region 20 preferably extends about 5 mm from the opening of the cavity 18 to the grip region 22. In the embodiment shown, the overall dimensions of the package 10 are approximately 30 mm wide, about 47 mm long and about 10 mm high. It should be appreciated, however, that the package 10 can have any size and/or shape as long as the aspects disclosed elsewhere herein are met.

The cavity 18 holds in a fluid tight manner, a contact lens and solution. The cavity 18 is bounded by a seal area 25 which is part of the flange region 20. The cover assembly 14 is preferably attached to the base member 12 by heat-sealing in the seal area 25; however, induction-sealing, sonic welding or another bonding system can be used to attach the cover assembly 14 to the base member 12. The total interior volume defined by the cavity 18 and the sealing assembly 12 is about 2.2 ml.

The present invention also provides a contact lens package which includes a contact lens and an amount of solution sealed within the cavity.

In certain embodiments of the present packages, such as the embodiment illustrated in FIG. 1, the contact lenses are hydrophilic lenses. Such hydrophilic lenses may be constructed from one or more monomeric unit components, i.e., monomeric components. For example, and without limitation, the monomeric unit component may comprise hydrophilic monomers which provide –OH, –COOH, –NCO(CH.sub.2).sub.3 (e.g., pyrrolidone) and the like groups. Examples of useful hydrophilic monomeric components include, without limitation, hydroxyalkyl methacrylates, such as hydroxyethyl methacrylate, methacrylic acid N-vinylpyrrolidone, acrylamide, alkyl acrylamides, vinyl alcohol, monomers, such as hydrophilic(meth)acrylates and the like and mixtures thereof, useful for inclusion in hydrophilic silicone polymeric materials, e.g., silicone hydrogels, silicone-containing monomers for polymerization into hydrophilic silicone polymers, siloxanes, such as organosiloxanes and the like and mixtures thereof, silicone-containing acrylates, silicone-containing methacrylates, and the like and mixtures thereof. Preferably, the lens is a hydrogel-containing lens, more preferably a silicone hydrogel-containing lens.

Ophthalmic lenses included in the packages of the present invention may include ophthalmic lenses made from biocompatible, non-hydrogel materials or components. Examples of non-hydrogel materials include, and are not limited to, acrylic polymers, polyolefins, fluoropolymers, silicones, styrenic polymers, vinyl polymers, polyesters, polyurethanes, polycarbonates, cellulosics, proteins including collagen-based materials and the like and mixtures thereof.

The fluid medium or solution contained in the cavity 18 can be any known solution useful for storing contact lenses including water, saline solutions, or buffered aqueous solutions. The contact lens and solution will preferably fill at least 50 percent, more preferably at least 70 percent, and most preferably at least 80 percent of the total volume defined by the cavity 18 and the cover assembly 14.

Referring now specifically to FIGS. 2 and 3, the base member 12 further comprises a rim portion 28 including an upwardly extending ridge 28a substantially surrounding the flange region 20. The rim portion 28 does not entirely circumscribe the holder 12. Referring now specifically to FIG. 2, the rim portion 28 tapers at opposing peripheral edges of the grip region 22 to define terminus 28t adjacent one side of the grip region 22 another opposing terminus 28t adjacent another side of the grip region 22.

In some embodiments of the present packages, the ridge 28a is structured to provide a barrier to contain overflow of solution, for example overflow of solution which can occur when the contact lens is being removed from the cavity 18. The rim portion 28 may further include a downwardly extending ridge 28b. As shown most clearly in FIG. 3, the downwardly extending ridge 28b downwardly extends a distance less that the depth of the cavity 18.

The grip region 22 is at least partially defined by a curved surface between the opposing peripheral edges of the grip region 22. The grip region 22 includes a first grip surface 22a and a substantially opposing second grip surface 22b (shown in FIG. 3). Similarly, the flange region 20 includes a first flange surface 20a and an opposing second flange surface 20b (shown in FIG. 3). The flange surfaces 20a and 20b are substantially planar and both of first grip surface 22a and second grip surface 22b are curved in shape.

In one embodiment, the first grip surface 22a extends away from the first flange surface 20a as a contiguous curve or slope such as shown. Preferably, the first grip surface 22a extends away from the first flange surface 20a at an angle of greater than 0.degree. and less than 90.degree. relative to the first flange surface 20a, (meaning a geometrical plane containing the first flange surface 20a). Even more preferably, the first grip surface extends away from the flange region at an angle of between about 30.degree. and about 60.degree., for example, at an angle of about 45.degree. relative to a plane containing the first flange surface 20a.

The first grip surface 22a may be substantially entirely concavely curved in form while the second grip surface 22b is substantially entirely convex in form.

In this embodiment, the first grip surface 22a is contoured in the form of a concavely curved “thumb grip” for facilitating manipulation of the package by a consumer. Importantly, in this embodiment, in conjunction with the concave curve of the first grip surface 22a for accommodating at least a portion of a human thumb, the second grip surface 22b is convexly curved, particularly at an inner surface portion 22c as shown in FIG. 3, to accommodate a curved or crooked forefinger of a human hand, such that the grip region 22 is easily, naturally and comfortably grippable by a consumer.

These aspects of the invention will be more clearly understood with reference to FIG. 3A, which shows an adult human thumb and forefinger gripping the contact lens holder 10 in a manner that feels comfortable and secure and greatly facilitates opening of the package 10 by the consumer. As shown, the holder 10 is structured to be held by the consumer manually gripping the base 12 as shown in FIG. 3A, for example, with the left hand, while the consumer removes the sealing assembly (not shown in FIG. 3A) with the right hand.

This can be contrasted with a prior art contact lens package 201, shown in FIG. 3B including a well 203 for holding a lens in a fluid medium, and a tab area 205. Tab area 205 is typically gripped between a tip of a thumb and a tip of a forefinger, for example in a “pinching” fashion. This prior art package 201 can not be firmly or even comfortably gripped in the relatively more secure manner of which package 10 is designed to be gripped.

As shown, the grip region 22 is recessed sufficiently deep so that a base surface 30 of the grip region 22 is located generally level with a base surface 32 of the cavity 18. This structure also facilitates handling of the package 10. For example, the stability provided by this design reduces the chance of the contact lens or solution being spilled from the cavity after opening of the cavity 18. For example, it can be appreciated upon referring to FIG. 3 that when the package 10 is placed in an upright position on the tabletop or other level surface, the base 30 of the grip region 22 and the base 32 of the cavity 18 rest against the tabletop surface and maintain the cavity 18 in a level position. In addition, if desired, the package 10 can be opened by placing the package on a tabletop or other surface, and stabilized by pressing the grip region 22 firmly against the tabletop surface, for example using a thumb or finger. Upon so stabilizing the package, the user can then open the cavity 18 by peeling away the sealing assembly 14, for example, in a direction generally away from the grip region 22.

Still referring to FIG. 3, in a related aspect, the grip region 22 comprises raised portion 34 including at least one ridge 34a raised from the first grip surface 22a and having a curved length (see FIG. 4). The grip region 22 further comprises at least one ridge 34 raised from the second grip surface 22b and having a curved length. In the embodiment shown, raised portion 34 includes three ridges 34a raised from first grip surface 22a and three opposing ridges 34b raised from second grip surface 22b. The raised portion 34 facilitates manual gripping of the grip region 22 by a user. The ridges 34a and 34b define curved spaced apart segments of radially concentric circles, for example substantially uniformly spaced apart segments, such as shown most clearly in FIGS. 2 and 4.

In another aspect, the cavity 18 is sized and shaped to accommodate a single contact lens immersed in solution, and is sized and shaped to facilitate removal of a contact lens from the cavity 18. The cavity 18 is preferably structured to accommodate a lens in a free floating position within the cavity and solution. By “free floating” is meant that the contact lens moves freely in the solution without adhering, in any significant degree, to surfaces of the cavity 18.

Referring to FIGS. 2 and 3, the cavity 18 is preferably defined by at least one curved region 36. The cavity 18 may be substantially entirely defined by a generally planar bottom region 38 and the curved side region 36 circumscribing the planar region 38. The generally planar region 38 may include a textured surface (texture not shown), for example a finely grooved or ridged surface, for example a striated surface, effective to reduce the possibility of the contact lens adhering to surfaces of the cavity.

In some embodiments of the invention the texture of the textured surface is visually nearly imperceptible to a naked eye of a person having substantially normal vision capabilities. In other words, the textured surface may appear smooth to a person having substantially normal vision capabilities even though the surface is textured to a significant degree in that, when compared to a relatively smoother surface, the surface will substantially inhibit adherence of the contact lens thereto.

In accordance with another aspect shown most clearly in FIGS. 2 and 3, the cavity 18 is contoured to enable a contact lens wearer to remove a contact lens from the cavity by means of the wearer’s fingertip, for example, when the cavity 18 is approached from substantially any rotational angle. For example, in a preferred embodiment of the invention, the curved side region 36 has a flattened upside down dome shape, for example an inner surface 36a defined by a uniformly sloped, generally frusto spherical surface having a substantially uniform radius of curvature circumscribing an inner surface 38a of the generally planar bottom region 38. The cavity 18 is preferably substantially entirely defined by the generally planar region 38 and the generally frusto spherical surface region 36. In some embodiments of the invention, the inner surface 36a of the curved side region 36 is texturally smooth relative to the inner surface of the bottom region 38.

Referring now to FIGS. 1 and 4, the cover assembly 14 is illustrated as comprising at least two elements, for example at least two different, separate layers of material. For example, in the embodiment of the invention shown, the cover assembly 14 preferably comprises a first member, i.e. first layer 52, and a second member, i.e. second layer 54 overlaying the first member 52. FIG. 4 shows the package 10 with a major portion of the second member 54 removed therefrom in order to more clearly reveal the first member 52 disposed beneath the second member 54. The first member 52 may be made of a laminate material that is heat sealed to the seal region 25 of the base member 12. The second member 54 preferably comprises a foil material, sealed to the rim portion 28 of the base member 12.

The second member 54 may comprise and at least one, for example two, polymer layers, e.g. polypropylene, coating the foil. The foil may comprise aluminum. The polymer coating material on the heat seal side of the foil may be polypropylene. Examples of useful cover layers are described in U.S. Pat. No. 4,691,820 incorporated herein in its entirety by this reference. The second member 54 may be sealed to the base member 12 along an entire circumference of the base member 12 as shown in FIG. 1, so as to provide a sanitary or sterile covering, for example by means of a hermetic seal, over both the first grip surface 22a and the first member 52.

The present packages described hereinabove can be structured to be substantially easier to use than prior art contact lens packages. In use, for example, a user removes the second member 54 by peeling the second member 54 away from the grip region 22. This may be facilitated by tab 54a (FIG. 1). The user then grips the package 10 between thumb and curved forefinger, as shown in FIG. 3A, for example, with the left hand. While the package is so secured, the user then carefully peels away the first member 52 facilitated by tab 52a (FIG. 4), using the right hand, thereby revealing the cavity 18 and the contents therein. The contact lens can then be easily removed from the cavity 18 with a fingertip.

FIG. 5 illustrates another prior art contact lens package 301. Package 301 is a polypropylene blister pack that is used to contain a polyHEMA contact lens in a sterile solution in the cavity 103.

FIG. 6 illustrates a contact lens package in accordance with another embodiment of the present invention. In this embodiment, the contact lens package 110 comprises a body member 112 with a cavity 118. A flange region 120 is shown extending from the cavity 118. A silicone hydrogel contact lens is shown at 113 and is provided in a liquid medium (not shown) in the cavity 118.

The contact lens package 110 is similar to the package illustrated in FIG. 5. However, the contact lens package is formed of a different grade of polypropylene than that of FIG. 5. For example, the contact lens package 110 can be formed from the polypropylene homopolymer PPH10042, disclosed hereinabove. In addition, the contact lens 113 located in the cavity 118 of the contact lens package 110 is a silicone hydrogel contact lens, and not a polyHEMA contact lens which is used in the package shown in FIG. 5.

As discussed in U.S. Patent Pub. No. 2005/0171232, it has been established that silicone hydrogel contact lenses stick to hydrophobic packaging materials, such as polypropylene-based blister packs and the like, unless a surfactant is present in the storage solution containing the silicone hydrogel contact lens. In addition, others have formed grooves or ridges on the bottom surface of the cavity of the packages to reduce the tendency for silicone hydrogel contact lenses to stick to the bottom surface of the cavity.

In contrast, it has been discovered that the present combination of hydrophobic material-based contact lens packages, such as polypropylene-based contact lens packages, and the silicone hydrogel contact lenses disclosed herein have a reduced tendency to stick or adhere to a surface forming the cavity of the present packages without requiring a surfactant or a ridge or a groove in the bottom surface of the cavity. Furthermore, the present lenses do not require a surface modification or surface treatment to make the surfaces of the lenses wettable.

Without wishing to be bound by any particular theory or mechanism of action, it is believed that the present reduced adherence is related to the enhanced wettability of the surfaces of the present lenses relative to existing silicone hydrogel contact lenses. The wettability of a contact lens surface can be related to the advancing contact angle and/or the difference between the advancing contact angle and receding contact angle (e.g., hysteresis). The present contact lenses, even without a surface treatment, have an advancing contact angle less than existing silicone hydrogel contact lenses. For example, the present lenses have an advancing contact angle less than 66.degree.. In certain embodiments, the advancing contact angle is less than about 60.degree., for example, the advancing contact angle may be about 55.degree. or less. In contrast, existing silicone hydrogel contact lenses have an advancing contact angle greater than 66.degree.. In addition, the present contact lenses can have a hysteresis less than about 18.degree.. In certain embodiments, the hysteresis is less than about 15.degree., such as less than about 10.degree.. In certain embodiments, the hysteresis of the present contact lenses is about 5.0.degree. or less. These values can be measured using the captive bubble method in phosphate buffered saline.

Thus, a mechanism for the reduced adherence of the present lenses can be attributed to the enhanced wettability of the surfaces of the present contact lenses relative to the wettability of the surfaces of other different silicone hydrogel contact lenses that are made of different materials and/or in different contact lens molds. For example, the present contact lenses may have a reduced advancing contact angle and/or hysteresis relative to existing silicone hydrogel contact lenses.

Therefore, in accordance with another embodiment of the present packages, it can be understood that a contact lens package comprises a base member having a cavity, a liquid medium located in the cavity, and a silicone hydrogel contact lens located in the liquid medium.

In this embodiment, such as shown in FIG. 6, the base member comprises a hydrophobic material. The base member has a bottom surface 138 and a sidewall 136 contacting the bottom surface 138 to form a cavity 118.

In the illustrated embodiment, the hydrophobic material comprises a polyolefin polymeric material. For example, the hydrophobic material of the base member may be a polypropylene polymer. Thus, the base member can be understood to be a molded polypropylene element.

In certain embodiments, such as the package 110, the bottom surface 138 is devoid of a ridge or a groove. In additional embodiments, the bottom surface 138 has a planar surface topography. Thus, it can be understood that the bottom surface 138 is smooth, and may cause other silicone hydrogel contact lenses to stick to the surface in the absence of any surface modification or the presence of a surfactant.

A liquid medium, such as a sterile packaging solution, is contained in the cavity. The liquid medium can include saline, a buffer, and other suitable components, including wettability enhancing agents and the like. In certain embodiments, the liquid medium is free of a surfactant, such as a surfactant-free medium. In other embodiments, the liquid medium comprises an amount of a surfactant effective to enhance the wettability of the silicone hydrogel contact lens contained in the liquid medium. This amount may be understood to be a wettability enhancing amount of the surfactant, and this amount can be different than the amount used to reduce the tendency of the silicone hydrogel contact lens to stick to the package.

Thus, in one embodiment, the liquid medium of the present packages comprises saline. The liquid medium may also comprise a phosphate buffer. For example, the liquid medium may be a phosphate buffered saline.

The silicone hydrogel contact lenses in this embodiment comprise a material effective in reducing the tendency for the lens to stick to the bottom surface of the cavity without requiring an anti-attachment agent selected from the group consisting of a surfactant, a surface modification of the bottom surface, and a combination thereof, to reduce the tendency of the lens to stick to the bottom surface. Thus, the present silicone hydrogel contact lenses can comprise a material that is different than existing silicone hydrogel contact lenses, such as those materials disclosed in U.S. Pat. Pub. No. 2005/0171232. The reduced tendency to stick associated with the present lenses may be relative to the tendency to stick for different silicone hydrogel contact lenses formed of different materials.

In certain embodiments, the silicone hydrogel contact lens of the present packages has an advancing contact angle of less than about 66.degree., or less than about 60.degree., or less than about 55.degree., and/or a hysteresis less than about 18.degree., or less than about 10.degree., or less than about 5.degree., as described herein. It is believed that the enhanced wettability of the present contact lenses compared to other different silicone hydrogel contact lenses may contribute to the reduced tendency of the silicone hydrogel contact lens to stick to a surface of the cavity of the present packages. In certain embodiments, the present contact lenses comprise contact lens forming materials, as disclosed in U.S. Application No. 60/604,961, filed Aug. 27, 2004 and U.S. Application No. 60/621,525, filed Oct. 22, 2004. For example, some of the present silicone hydrogel contact lenses comprise a plurality of silicon-containing macromers. In certain lenses, the lenses comprise a combination of a polymethylsiloxane methacrylate derivative and a polysiloxanyl dimethacrylate. The lenses may also comprise other components useful in forming silicone hydrogel contact lenses, including without limitation, sulfosuccinates, isocyantes, pyrrolidonones, methacrylates, and acetamides. Silicone hydrogel contact lenses that comprise materials with a reduced tendency to stick to a hydrophobic packaging material without requiring a surfactant or surface modification of a surface of the cavity, can be produced using materials suitable for silicone hydrogel contact lenses and routinely tested for sticking by placing the lenses in the present packages and liquid media. In addition, such lenses can be selected based on the desired advancing contact angle and/or hysteresis, as described herein.

As shown in FIG. 6, the base member 112 of the present packages 110 can comprise a flange 120 extending from the cavity. The flange can be held by a person when removing the contact lens from the package.

The present packages 110 may also comprise a seal similar to that described for the other embodiments herein. The seal can be a cover assembly such as that described in FIGS. 1 and 4 herein. The seal is attached to the base member to maintain the contact lens in a sterile environment until ready for use by a person.

The present packages may comprise a cavity defined by a sidewall that has at least one planar surface 137a and at least one curved surface 137b, each of which is substantially perpendicularly oriented to the bottom surface 138 of the cavity 118. Alternatively, the present packages may comprise a sidewall that is oriented at a non-perpendicular angle to the bottom surface 138, such as the curved surface 36 shown in FIG. 3.

In view of the disclosure herein, the present silicone hydrogel contact lenses can be understood to have a reduced tendency to become attached to the bottom surface of the package body or cavity relative to different silicone hydrogel contact lenses formed of different materials, wherein the reduced tendency is substantially unaffected by the presence of a surfactant in the liquid medium.

The base members of the present packages can be formed using conventional techniques of forming contact lens packages. For example, the base members can be formed using injection molding or thermomolding techniques. In certain situations, the base members will be formed in a strip of two or more base members attached to each other. In one embodiment, the three base members are attached along an edge to form a strip of three blister packs. The cavity in each base member is filled with a liquid medium suitable for storing contact lenses, such as silicone hydrogel contact lenses, in a sterile condition. In certain embodiments, the medium is a surfactant-free medium. In other embodiments, the medium comprises a wettability enhancing amount of a surfactant. After inspecting and placing a contact lens in the liquid medium of a cavity, the base member is sealed, and may be labeled for distribution, storage, and the like.

The contact lenses may be removed from the package by removing the seal and taking the lens out of the liquid medium and placing the lens on or in an eye of an individual.

Certain aspects and advantages of the present invention may be more clearly understood and/or appreciated with reference to the following commonly owned United States Patent Applications, filed on even date herewith, the disclosure of each of which is being incorporated herein in its entirety by this specific reference: U.S. patent application Ser. No. 11/200,848, entitled “Contact Lens Molds and Systems and Methods for Producing Same”; U.S. patent application Ser. No. 11/200,648, entitled “Contact Lens Mold Assemblies and Systems and Methods of Producing Same”; U.S. patent application Ser. No. 11/200,644, entitled “Systems and Methods for Producing Contact Lenses from a Polymerizable Composition”; U.S. patent application Ser. No. 11/201,410, entitled “Systems and Methods for Removing Lenses from Lens Molds”; U.S. patent application Ser. No. 11/200,863, entitled “Contact Lens Extraction/Hydration Systems and Methods of Reprocessing Fluids Used Therein”; U.S. Patent Application No. 60/707,029, entitled “Compositions and Methods for Producing Silicone Hydrogel Contact Lenses”; and U.S. patent application Ser. No. 11/201,409, entitled “Systems and Methods for Producing Silicone Hydrogel Contact Lenses”.

While this invention has been described with respect to various specific examples and embodiments, it is to be understood that the invention is not limited thereto and that it can be variously practiced within the scope of the following claims.

1. A contact lens having a top, a bottom, a rotational axis, a front surface and a base surface, the front surface including a plurality of zones, comprising: an optical zone having a lower edge, including: a distance vision zone having a curvature range that provides distance vision correction and having a first area that is sufficient to overlay a substantial portion of a pupil of a user and disposed in a first position within the optical zone so that the user’s pupil is substantially subtended by the distance vision zone when the user is gazing at a substantially horizontal point in primary gaze; a near vision zone, extending radially outward from the distance vision zone, having a second curvature range that provides near vision correction and having a second area that is sufficient to overlay a substantial portion of a pupil of a user and disposed in a second position within the optical zone so that the user’s pupil is substantially subtended by the near vision zone when the user is gazing at a near vision point below the substantially horizontal point in down-gaze; and a ledge zone disposed below the optical zone, that includes an undercut portion extending outwardly from the base surface to the front surface to enable engagement with a lower eyelid of a user and thereby provide vertical translation support for the contact lens when being worn by the user.

2. The lens of claim 1, further comprising a transition zone extending from the lower edge of the optical zone to the upper edge of the ledge zone that provides a smooth transition from the ledge zone to the optical zone.

3. The lens of claim 1, further comprising a bevel zone, extending radially outward that tapers to a narrow end.

4. The contact lens of claim 1, wherein the distance vision zone has a center that is offset from the rotational axis of the contact lens.

5. The contact lens of claim 1, wherein the distance vision zone has an oval shape.

6. The contact lens of claim 1, wherein said lens has a thickness profile that increases along the vertical meridian.

7. The lens of claim 6, wherein said lens has a thickness profile that is symmetric about the vertical meridian.

8. The lens of claim 1, wherein the height of said ledge is between about 300-um and about 1200-um along the inferior vertical meridian.

9. The lens of claim 1, wherein the height of said ledge is about 700-um.

10. The lens of claim 1, wherein the ledge has an angular range between about 25 degrees and about 70 degrees measured from the vertical.

11. The lens of claim 1, wherein the angle of the ledge is about 50 degrees to the vertical.

12. The contact lens of claim 3, wherein the distance vision zone has an oval shape.

13. The contact lens of claim 1, wherein the near vision zone is substantially concentric with the rotational axis and extends radially outward from the distance vision zone.

14. The lens of claim 1, wherein said lens is capable of large amplitude translation in the range of about 2 mm to about 5 mm.

15. The lens of claim 1, wherein said lens is capable of large amplitude translation in the range of about 3 mm to about 5 mm.

16. The contact lens of claim 1, wherein the contact lens is comprised of soft contact lens material.

17. The contact lens of claim 16, wherein the soft contact lens material comprises a silicon hydro-gel.

18. The contact lens of claim 16, wherein the soft contact lens material comprises HEMA.

19. A mold capable of creating a lens wherein said created contact lens has a top, a bottom, a rotational axis, a front surface and a base curve, the front surface including a plurality of zones, comprising: an optical zone having a lower edge, including: a distance vision zone having a curvature range that provides distance vision correction and having a first area that is sufficient to overlay a substantial portion of a pupil of a user and disposed in a first position within the optical zone so that the user’s pupil is substantially subtended by the distance vision zone when the user is gazing at a substantially horizontal point in primary gaze; a near vision zone, extending radially outward from the distance vision zone having a second curvature range that provides near vision correction and having a second area that is sufficient to overlay a substantial portion of a pupil of a user and disposed in a second position within the optical zone so that the user’s pupil is substantially subtended by the near vision zone when the user is gazing at a near vision point below the substantially horizontal point in down-gaze; and a ledge zone disposed below the optical zone, that includes an undercut portion extending outwardly from the base curve to the front surface to enable engagement with a lower eyelid of a user and thereby provide vertical translation support for the contact lens when being worn by the user.

20. A method of making a lens capable of large amplitude translation comprising the steps of: cutting a first surface in lens material, wherein said first surface comprises a base curve, including an undercut, wherein said undercut is designed to be engaged by a lower eyelid; supporting said undercut; transferring said lens material; and cutting a second surface, wherein said second surface comprises a front surface; wherein the undercut extends outwardly from the base curve to the front surface.

21. The method of claim 20, wherein said supporting step further comprises adding blocking material behind the base curve and undercut.

22. The method of claim 20, wherein said second cut removes material from the superior boundary of the lens to produce an oblong lens shape.

23. A method of making a lens mold capable of creating a lens with large amplitude translation comprising the steps of: cutting a first surface in lens mold material, wherein said first surface comprises a male mold, including an undercut; supporting said undercut; transferring said lens mold material; and cutting a second surface, wherein said second surface comprises a female mold; wherein the undercut extends outwardly from the first surface to the second surface.
Contact Lens Description
The present invention is directed to a contact lens design where the optics position relative to the pupil is controlled by the lens relationship to the lower lid. More specifically, the present invention provides a lens design that allows large amplitude translation on the eye through use of an undercut ledge.

BACKGROUND OF THE INVENTION

Contact lenses are widely used for many different types of vision deficiencies. These include defects such as near-sightedness and far-sightedness (myopia and hypermetropia, respectively), and defects in near range vision usually associated with aging (presbyopia). Current opinion holds that presbyopia occurs as a person ages when the lens of eye begins to crystallize and lose its elasticity, eventually resulting in the eye losing the ability to focus on nearby objects.

Some presbyopic persons have both near vision and far vision defects, requiring bifocal lenses to properly correct their vision. Many people prefer wearing contact lenses to correct their vision rather than bifocal eye glasses.

A typical single vision contact lens has a focus, which is the point on which parallel rays of light focus when the lens is placed perpendicular to the parallel rays, and an optical axis, which is an imaginary line drawn from the focus to the center of the lens. A posterior surface fits against the cornea and an opposite anterior surface has a vision surface that focuses light to correct the eye’s vision. In the case of a typical spherical lens, the vision surface has a single radius of curvature that is the distance from any point on the vision surface to a point on the optical axis referred to as the center of curvature. A bifocal lens has at least two vision surfaces on the anterior surface of the lens: a distance vision surface, for gazing at far off objects, and a near vision surface, for gazing at close objects (e.g., while reading).

Effective use of a bifocal contact lens requires translation of the eye between vision surfaces when the eye changes from gazing at an object at a distance to gazing at a nearby object. In such a situation, the pupil must move from being subtended by the distance vision surface to being subtended by the near vision surface.

In designing a lens, translation is of particular importance. Most lenses have difficulty translating across the surface of the eye when the visual direction of the eye changes from horizontal gaze distance vision to down gaze near vision. This is due to the ability of a soft contact lens to conform closely to the shape of the cornea. For this reason, soft translating bifocal contact lenses are uncommon. Thus, users who desire bifocal contact lenses are usually limited to using the more uncomfortable hard lenses, while those who wish to wear soft contact lenses are usually limited to wearing mono-focal lenses.

Therefore, there is a need for a soft bifocal contact lens that supports translation across the surface of the eye when the eye changes position from distance vision to near vision. Lenses with a translation “ridge” on the front surface have been produced; however, if the ridge feature does not have an undercut, the lid may not engage the lens and hence, the lens translation amplitude may be insufficient, resulting in poor bifocal performance.

If the ridge is located close to the edge, on a steeper position of the lens, the lid tends to roll over the ridge feature and the lens does not translate. If the ridge is positioned nearer to the center of the lid, where the lid can engage the ridge, the lower lid may not provide enough movement for effective amplitude of the lens translation.

An undercut features currently require slides in the mold bases during the injection molding process, which prevents use of high volume mold manufacture.

SUMMARY OF THE INVENTION

The present invention includes a method for manufacturing a translating lens as well as a design for translating lens. The contact lens of the present invention preferably has a top, a bottom, a rotational axis, a front surface and a base surface. The front surface includes a plurality of zones, one of which is an optical zone having a lower edge with a distance vision zone having a curvature range that provides distance vision correction and having a first area that is sufficient to overlay a substantial portion of a pupil of a user and disposed in a first position within the optical zone so that the user’s pupil is substantially subtended by the distance vision zone when the user is gazing at a substantially horizontal point in primary gaze. In another embodiment, the distance vision zone may have a center that is offset from the rotational axis of the contact lens. In a related embodiment, the distance vision zone may be in the shape of an oval.

The front surface also has an optical zone with a near vision zone, extending radially outward from the distance vision zone, having a second curvature range that provides near vision correction and having a second area that is sufficient to overlay a substantial portion of a pupil of a user. This near vision zone is preferably disposed in a second position within the optical zone so that the user’s pupil is substantially subtended by the near vision zone when the user is gazing at a near vision point below the substantially horizontal point in down-gaze. In a related embodiment, the near vision zone may be substantially concentric with the rotational axis and may extend radially outward from the distance vision zone.

A ledge zone is preferably disposed below the optical zone and includes an undercut portion extending outwardly from the base surface to the front surface to enable engagement with a lower eyelid of a user to provide vertical translation support for the contact lens when being worn by the user. In one embodiment of the present invention, the height of the ledge may be between about 300-um and about 1200-um along the inferior vertical meridian. In a more preferred embodiment, the height of the ledge may be 700-um. In a related embodiment, the ledge may have an angular range from about 25 degrees to 70 degrees as measured from the vertical. In a preferred embodiment, the angle of the ledge is about 50 degrees from the vertical.

In one embodiment of the present invention, the lens may also have a transition zone that extends from the lower edge of the optical zone to the upper edge of the ledge zone and provides a smooth transition from the ledge zone to the optical zone. In a related embodiment the lens has a bevel zone that preferably extends radially outward and tapers to a narrow end. In still another embodiment, a lens of the present invention may have a thickness profile that increases along a vertical meridian. In a related embodiment, the lens may have a thickness profile that is substantially symmetric about the vertical meridian.

Lenses of the present invention may be made of a silicon hydrogel or HEMA. Lenses of the present invention are preferably capable of large amplitude translation. In one embodiment, the lens is capable of translating about 2 mm to about 5 mm. In a preferred embodiment, the lens is capable of translating about 3 mm to about 5 mm.

The present invention also includes a mold that is capable of creating the lens of the present invention. Additionally, the present invention includes a method of making a lens capable of large amplitude translation. This method includes cutting a first surface in lens material, the first surface including a base curve with an undercut designed to be engaged by a lower eyelid; supporting the undercut; transferring the cut lens material; and cutting a second front surface. In another embodiment, the supporting step may include adding blocking material behind the first cut surface. In still another embodiment, the second cut may remove material from the superior boundary of the lens to produce an oblong lens shape.

The present invention also includes a method of making a lens mold capable of creating a lens with large amplitude translation. This method includes cutting a first surface in lens mold material, the first surface including a male mold with an undercut; supporting the undercut feature of the mold; and; and cutting a second front surface, which is a female mold.

These and other aspects of the invention will become apparent from the following description of the preferred embodiments taken in conjunction with the following drawings. As would be obvious to one skilled in the art, many variations and modifications of the invention may be effected without departing from the spirit and scope of the novel concepts of the disclosure.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a front elevational view of one embodiment of the invention.

FIG. 1B is a cross-sectional view, exaggerated along the horizontal axis, of the embodiment shown in FIG. 1A, taken along line 1B-1B.

FIG. 1C is a detail portion of FIG. 1B.

FIG. 2A is a side elevational view of an uncut button of lens material mounted on a spindle.

FIG. 2B is a side elevational view of the button of FIG. 2A after a first surface has been cut.

DETAILED DESCRIPTION OF THE INVENTION

Reference now will be made in detail to the embodiments of the invention. It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment, can be used on another embodiment to yield a still further embodiment. Thus, it is intended that the present invention cover such modifications and variations as come within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are obvious from the following detailed description. It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention.

A preferred embodiment of the invention is now described in detail. Referring to the drawings, like numbers indicate like parts throughout the views. As used in the description herein and throughout the claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise: the meaning of “a,” “an,” and “the” includes plural reference, the meaning of “in” includes “in” and “on.”

As shown in FIGS. 1A-1C, one embodiment of the invention is a contact lens 100 having top 108, a bottom 109, a rotational axis 102, an posterior surface 104 and an opposite anterior surface 106. The anterior surface 106 may include an optical zone 110, a transition zone 140, a ledge 150 and an undercut 158. The optical zone 110 has a lower edge 114 and includes a distance vision zone 120 and a near vision zone 130. The base (posterior) surface of the lens may have a circular boundary edge, from which, a ledge protrusion is extended from the inferior half of the lens. The base surface, less the ledge feature, may be rotationally symmetrical or may include a toric or biconic optical surface that is blended into a rotationally symmetrical base surface outer portion.

The distance vision zone 120 has a first curvature range that provides distance vision correction for the user. The area of the distance vision zone 120 is sufficient to overlay a substantial portion of a pupil 106a of a user (i.e. cover at least 50% of the pupil). The distance vision zone 120 is disposed so that the user’s pupil is substantially subtended by the distance vision zone 120 when the user is gazing at a substantially horizontal point in primary gaze. Typically, the distance vision zone 120 will be offset from the rotational axis 102. This is so that the pupil 106 will be substantially subtended by the near vision zone 130 when the eye 107 is viewing in downgaze (e.g., when the eye 107 is engaged in reading). The distance a from the center 102 to the bottom of the distance vision zone 120 should be the minimum distance that allows the pupil 106a to be substantially subtended by the distance vision zone 120 when gazing at the horizon. This may result in the distance vision zone 120 having an oval shape. The distance zone 120 preferably provides vertical coma during downward gaze, when the lens translates inferiorly.

A blend zone preferably exists between the distance zone 120 and the near vision zone 130. This blend zone preferably includes surface inflection and a high relative curvature as compared to the curvature of the optical zone. Because optical power is proportional to curvature, light refracted by the blend zone is refracted away from the fovea.

A vertical meridian extends from the top of the lens 108 to the bottom of the lens 109. In the present invention, the optical zone is preferably located along the vertical meridian, which is preferably greater than about 9 mm in length. In a more preferred embodiment, the length of the optical zone is about 10.5 mm. As shown in FIG. 1B, the lens has a thickness profile. In a preferred embodiment, the thickness profile increases from the top of the lens 108 to the bottom of the lens 109, resulting in greater lens thickness towards the bottom of the lens. The lens also has a horizontal meridian that extends from the left side of the lens to the right side of the lens. In a preferred embodiment, the thickness profile along the horizontal meridian is substantially symmetric.

The near vision zone 130 may be substantially concentric with the rotational axis 102 and extends radially outward from the distance vision zone 120. The near vision zone 130 has a second curvature range that provides near vision correction for the user. The area of the near vision zone 130 is sufficient to overlay a substantial portion of the pupil 106b. The near vision zone 130 is disposed so that the user’s pupil 106b is substantially subtended by the near vision zone 130 when the user is gazing at a near vision point below the substantially horizontal point in down-gaze (e.g., while reading). Both the distance vision zone 120 and near vision zone 130 may be placed either on the posterior surface 104 or the anterior surface 106 of the lens 100.

Referring to FIGS. 1A and 1B, the ledge 150 provides vertical translation support for the lens 100. Such support may allow the lens to translate in the range of about 2 mm to about 5 mm, preferably in the range of about 3 mm to 5 mm. The ledge 150 has a front portion 156 and an undercut lower edge 158. The ledge 150 is located below the optical zone 110. Undercut lower edge 158 extends between the front surface and base curve of the lens and is situated at an angle to front portion 156. Undercut lower edge 158 enables engagement with the user’s lower eyelid 105. Thus, when the eye 107 moves in a downward direction, the ledge, specifically, undercut lower edge 158, engages the lower eyelid 105 and supports the lens 100, thereby allowing translation of the lens 100 across the surface of the eye 107.

The height of the ledge, measured as the thickness along the inferior vertical meridian at the edge, is preferably between about 300 um and about 1200 um. In a preferred embodiment, the height of the lens is about 700-um. The angle of the ledge from the vertical may range from about 25 to about 70 degrees. In preferred embodiment, the height of the ledge, to vertical, is about 50 degrees.

The transition zone 140 provides a smooth transition from the ledge 150 to the optical zone 110. The transition zone 140 extends from the lower edge 114 of the optical zone 110 to the upper edge of the ledge 156. This “surface blending,” just above the ledge, may be concave (if the maximum thickness is at the edge) to flat, along the inferior vertical meridian.

The lens may also include other features normally associated with contact lenses. For example, the prism of the lens will typically be about 200 um from top to bottom

For added comfort, the lens 100 may also include a bevel 170. Bevel 170 may be a variable reverse bevel on the base curve or fully tangent surface. The lens may also have an offset progressive to add intermediate vision in primary gaze. Virtually any optics may be used in conjunction with the present lens design. For example, one embodiment of the present invention may have an inferior offset progressive zone. Another embodiment may include optics that are created with a combined coma-like aberration and progressive profile. In still other embodiment, the lens design may include astigmatic correction on either the front surface or the base surface of the lens. In another embodiment, the lens may have greater than one diopters of negative spherical aberration, for a 6 mm pupil, on the distance zone.

The present lens design is designed such that the lens, tools, or molds can be fabricated via an ophthalmic lathe or its equivalent.

A lens 100 according to the invention typically would be made from a soft contact lens material, such as a silicon hydrogel or HEMA. Although, it will be understood that any lens described above comprising any soft contact lens material would fall within the scope of the invention.

A contact lens according to the invention could be constructed using a conventional contact lens molding process or can be cut on a lathe. In an embodiment using a molding process, the mold or the mold tools may be formed on a conventional computer-controlled cutter in conjunction with a lathe, of the type conventionally used in making master casts of contact lenses. Irrespective of whether the lens, the lens mold, or the mold tools are lathed, the lathing process may be similar as described herein for a lens. As such, the discussion below is exemplary only and should not be limited solely to the manufacture of a lens; rather, the following process may be used for a lens, a lens mold, or a mold tool.

As shown in FIG. 2A, a material 200 is mounted on a spindle 220 and is rotated around a rotational axis 202 in a pre-selected direction A. Specifically, the material may be in the shape of a button and clamped or otherwise attached to a pin. Initially, as shown in FIG. 2B, at least one first surface 210 is cut onto the outer surface 206 of the blank or button 200. The first surface 210 is preferably the posterior surface or base curve, which preferably includes the undercut feature of the lens of the present invention (ledge zone). During this process, a shoulder clamp is preferably used to block off the edges of the button. Additionally, wax, or another blocking material that does not scratch the surfaces of lenses, lens molds, or mold tools may be used to block the cut base curve during transfer. The blocking material may also provide support for the undercut feature. After the first surface is cut, the partially formed lens is transferred such that the second side, or anterior surface, may be cut. During the transfer the blocking material remains in place to prevent damage to the first cut surface. Additionally, keys or slots may be used to ensure that the lens remains in proper orientation relative to the spindle. This is particularly important in lenses that are aspherical. The front surface is cut in the same general manner as the back surface, except that the optical zone, the transition zone, and the bevel zone may be cut on the front surface. In an alternative embodiment, these zones may be cut on the back surface. The various vision surfaces may be cut in the lens, lens mold, or mold material by controlling the depth of the cutting instrument (as with a conventional computer control mechanism) as the material rotates.

During the second cut to the front surface, the diameter of the lens, lens mold and/or mold tools, may be cut to produce a pronounced undercut resulting in an oblong shape. Removing some of the diameter of the lens may provide better stability and increased translation. The boundary of the inferior half of the lens may vary with azimuthal angle such that the boundary is not circular and the edge does not lie in a plane. In a preferred embodiment, the boundary of the lens in the superior half is symmetrical and lies in the same plane. In another embodiment, the lens may have an edge round that varies as a sinusoid around, at least, the superior half of the lens. In an embodiment of the present invention in which a mold is created, the mold is preferably created such that lenses created by the mold may have an edge round that varies as a sinusoid around, at least, the superior half of the lens.

The above described embodiments are given as illustrative examples only. It will be readily appreciated that many deviations may be made from the specific embodiments disclosed in this specification without departing from the invention. Accordingly, the scope of the invention is to be determined by the claims below rather than being limited to the specifically described embodiments above.

1. A contact lens, comprising: a non-opaque pupil section; an iris section surrounding the pupil section; and a colored opaque intermittent pattern overlying about 20% of the iris section, wherein the colored opaque intermittent pattern comprises an outermost starburst portion comprising dots of a first shade; an outer starburst portion comprising dots of a second shade and overlapping at least a portion of the outermost starburst portion, wherein the first and second shades are different from one another; and an inner starburst portion comprising dots of a third shade and overlapping at least a portion of the outer starburst portion, wherein the overlapping of the dots of the outer starburst portion and the inner starburst portion blend together to produce a fourth shade, wherein the overlapping of the dots of the outermost starburst and the outer starburst and the overlapping of the dots of the outer starburst and the inner starburst are indiscernible to an ordinary person, and wherein the contact lens is capable of changing the apparent color of the iris of the wearer of the lens while imparting a natural appearance.

2. The contact lens of claim 1, wherein the dots are at least one of round, square, hexagonal, or elongated dots.

3. The contact lens of claim 1, wherein the colored, opaque intermittent pattern further includes a plurality of interstices between the dots, wherein the interstices are non-opaque.

4. The contact lens of claim 3, wherein the non-opaque interstices are translucently colored.

5. The contact lens of claim 3, wherein the non-opaque interstices are uncolored.

6. The contact lens of claim 1, wherein the first and third shades are the same color.

7. A contact lens, comprising: a non-opaque pupil section; an iris section surrounding the pupil section; and a colored opaque intermittent pattern overlying no more than about 30% of the iris section, wherein the colored opaque intermittent pattern comprises an outermost starburst portion comprising dots of a first shade, wherein the first shade includes the darkest color of the pattern; an outer starburst portion comprising dots of a second shade and overlapping at least a portion of the outermost starburst portion, wherein the first and second shades are different from one another; and an inner starburst portion comprising dots of a third shade and overlapping at least a portion of the outer starburst portion, wherein the overlapping of the dots of the outer starburst portion and the inner starburst portion blend together to produce a fourth shade, wherein the overlapping of the dots of the outermost starburst and the outer starburst and the overlapping of the dots of the outer starburst and the inner starburst are indiscernible to an ordinary person, and wherein the contact lens is capable of changing the apparent color of the iris of the wearer of the lens while imparting a natural appearance.

8. The contact lens of claim 7, further comprising an uneven border between each portion.

9. The contact lens of claim 7, wherein the shade of the outermost starburst portion is at least one of black, gray, dark brown, and dark blue.

10. The contact lens of claim 7, wherein the shade of the outer starburst portion is at least one of blue, gray brown, light blue, turquoise, violet, blue violet, aqua, yellow, and green.

11. A contact lens, comprising: a non-opaque pupil section; an iris section surrounding the pupil section; and a colored opaque intermittent pattern overlying no more than about 30% of the iris section, wherein the colored opaque intermittent pattern comprises an outermost starburst portion comprising dots of a first shade; an outer starburst portion comprising dots of a second shade and overlapping at least a portion of the outermost starburst portion, wherein the first and second shades are different from one another; and an inner starburst portion comprising dots of a third shade and overlapping at least a portion of the outer starburst portion, wherein the overlapping of the dots of the outer starburst portion and the inner starburst portion blend together to produce a fourth shade, wherein the overlapping of the dots of the outermost starburst and the outer starburst and the overlapping of the dots of the outer starburst and the inner starburst are indiscernible to an ordinary person, wherein the contact lens is capable of changing the apparent color of the iris of the wearer of the lens while imparting a natural appearance, and wherein the shade of the inner starburst portion is at least one of hazel, yellow, yellow green, brown, yellow brown, gold, and orange.

12. The contact lens of claim 11, wherein the dots of the outermost starburst portion extend to a periphery of the lens.
Contact Lens Description
TECHNICAL FIELD

The present invention relates to colored contact lenses and in particular to such lenses having multiple opaque colored portions that form a pattern that can change the apparent color of the iris while imparting a very natural appearance.

BACKGROUND OF THE INVENTION

Early attempts to modify or enhance the color of one’s eyes utilized colored contact lenses with a simple solidly colored area that covered the iris portion of the eye. However, contact lenses with this type of opaque coloring imparted a very unnatural appearance. Other types of colored contact lenses were developed, such as Wichterle, U.S. Pat. No. 3,679,504, which discloses an opaque lens having an iris of more than a single color artistically drawn or photographically reproduced. However, such lenses did not look natural and as such never achieved commercial success. Other attempts to produce an opaque lens with a natural appearance are disclosed in. U.S. Pat. No. 3,536,386, (Spivak); U.S. Pat. No. 3,712,718 (LeGrand), U.S. Pat. No. 4,460,523 (Neefe), U.S. Pat. No. 4,719,657 (Bawa), U.S. Pat. No. 4,744,647 (Meshel et al.), U.S. Pat. No. 4,634,449 (Jenkins); European Patent Publication No. 0 309 154 (Allergan) and U.K Patent Application No. 2 202 540 A (IGEL).

Commercial success was achieved by the colored contact lens described in Knapp (in U.S. Pat. No. 4,582,402) which discloses a contact lens having, in its preferred embodiment, colored, opaque dots. The Knapp lens provides a natural appearance with a lens that is simple and inexpensive to produce, using a simple one-color printed dot pattern. Although the intermittent pattern of dots does not fully cover the iris, it provides a sufficient density of dots that a masking effect gives the appearance of a continuous color when viewed by an ordinary observer. Knapp also discloses that the printing step may be repeated one or more-times using different patterns in different colors, since upon close examination the iris is found to contain more than one color. The printed pattern need not be absolutely uniform, allowing for enhancement of the fine structure of the iris. The one-color Knapp lenses currently achieving commercial success have their dots arranged in an irregular pattern to enhance the structure of the iris. However, neither the Knapp commercial lenses, nor the Knapp patent disclose or suggest how one would arrange a pattern of dots having more than one color to achieve a more natural appearance.

Various efforts have been made to improve on the Knapp lens. U.S. Pat. No. 5,414,477 to Jahnke discloses the application of the intermittent ink pattern in two or more portions of distinct shades of colorant to provide a more natural appearance.

Other attempts to create a more natural appearing lens include U.S. Pat. No. 5,120,121 to Rawlings, which discloses a cluster of interconnecting lines radiating from the periphery of the pupil portion to the periphery of the iris portion. Further, European Patent No. 0 472 496 A2 shows a contact lens having a pattern of lines that attempts to replicate the lines found in the iris.

Despite these efforts, the contact lens industry continues to seek a low-cost, colored lens that can enhance or modify the eye color, while providing the depth and texture that is inherent in the human iris.

SUMMARY OF THE INVENTION

The present invention is based on the surprising discovery that a pattern having multiple-color opaque portions can achieve a more natural appearing iris if configured properly. The improvement in appearance over the one-color Knapp lenses and the multiple-color Jahnke lenses is startling. Like the one and two color lenses, the lenses of this invention are able to cause a fundamental change in the apparent color of the wearer’s iris, e.g. from dark brown to light blue or green. Although a preferred embodiment of the invention is a three color lens wherein different colors overlap, more than three colors are contemplated, and lenses wherein all three (or more) of the different colors overlap are also contemplated.

One objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section. The elements of the pattern are indiscernible to the ordinary viewer and are made up of a first portion of the elements of the pattern, which is a first shade, and a second portion of the elements of the pattern, which is a second shade different from said first shade, and a third portion of the elements of the pattern, which is a third shade different from said second shade and either different or the same as the first shade. Each of the three portions contain overlapping, mixing and blending elements consisting of or making up, uniform and non-uniform dots, islands of colors, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and/or streaks, in combination or separately. Further, each of the overlapping portions may or may not extend from one end of the non-opaque pupil section to the periphery of the iris section. The blending of these various portions creates a lens capable of changing the apparent color of the iris of a person wearing the lens, while imparting a very natural appearance.

Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section. The elements of the pattern are indiscernible to the ordinary viewer and are made up of a first portion of the elements of the pattern, or the outermost starburst, which is a first shade, and a second portion of the elements of the pattern, or the outer starburst, which is a second shade different from said first shade, and a third portion of the elements of the pattern, or the inner starburst, which is a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements located generally outside the inner starburst. A first uneven border differentiates the outermost and outer starbursts, although there is overlap of the outermost and outer starbursts. A second uneven border differentiates the outer and inner starbursts, although there is overlap between the outer and inner starbursts. Thus, a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided.

Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern covers at least about 25 percent of the area of the iris section. The elements of the pattern are indiscernible to the ordinary viewer. A first portion of the elements of the pattern, or the outermost starburst, is of a first shade, and a second portion of the elements of the pattern, or the outer starburst, is of a second shade different from said first shade, and a third portion of the elements of the pattern, or the inner starburst, is of a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements located generally outside of the inner starburst. A first uneven border differentiates the outermost and outer starbursts although the outermost and outer starbursts overlap, and a second uneven border differentiates the outer and inner starbursts although the outer and inner starbursts overlap. The minimum distance of the first uneven border from the outer perimeter of said iris section is from about 5% to about 60% of the radial width of said iris section. The maximum distance of the first uneven border from the outer perimeter of said iris section is from about 25% to about 95% of the radial width of the iris section. The minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 75% of the radial width of the iris section, and the maximum distance of said second uneven border from the outer perimeter of the iris section is from about 50% to about 95% of the radial width of the iris section. Thus, a contact lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided.

Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern covers at least about 25 percent of the area of the iris section. The elements of the pattern are indiscernible to the ordinary viewer. A first portion of the elements of the pattern, or the outermost starburst, is of a first shade, and a second portion of the elements of the pattern, or the outer starburst, is of a second shade different from said first shade, and a third portion of the elements of the pattern, or the inner starburst, is of a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements located generally on the outside of the inner starburst. A first uneven border differentiates the outermost and outer starbursts although the outermost and outer starbursts overlap, and a second uneven border differentiates the outer and inner starbursts although the outer and inner starbursts overlap. The minimum distance of the first uneven border from the outer perimeter of said iris section is from about 15% to about 50% of the radial width of said iris section. The maximum distance of the first uneven border from the outer perimeter of said iris section is from about 45% to about 95% of the radial width of the iris section. The minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 65% of the radial width of the iris section, and the maximum distance of said second uneven border from the outer perimeter of the iris section is from about 60% to about 95% of the radial width of the iris section. Thus, a contact lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided.

Yet another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of multiple portions, each of which is a different shade from the other portion. These portions may or may not overlap each other at multiple points. At least one of the multiple portions is a design that contains either uniform or non-uniform dots, islands of color, worms, starbursts, spokes, spikes, striations, radial stripes, zigzags and/or streaks, or some other design that, along with the other portions, provides a lens capable of changing the apparent color of the iris of the person wearing the lens, while imparting a very natural appearance.

Yet another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern, which is made up of elements, covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of multiple portions, each of which is a different shade from the other portion. Further, one of these portions is the darkest shade, one of these portions is the lightest shade, and the pattern is configured so that the darkest shaded portion has the greatest concentration of elements located generally outside the other portions. This design provides a lens capable of changing the apparent color of the iris of the person wearing the lens, while imparting a very natural appearance.

Yet another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern, which is made up of elements, covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of at least three portions, each of which is a different shade from each other portion. Each of the portions overlap the other portion at multiple points. These overlapping portions blend, mix or commingle together, or appear to blend, mix or commingle together, producing unique textures, colors and patterns that make the eye look natural when the contact lens is placed on the eye. To obtain the commingling or blending of the portions, in some instances the different shades will be printed in the same location or close enough that the difference in location is not discernible. This design provides a lens capable of changing the apparent color of the iris of a person wearing the lens, while imparting a very natural appearance.

It can be easily understood that other colored lenses having patterns with multiple portions (having different shades or colors) can be designed and still fall within the scope of the present invention.

The term “non-opaque” as used herein is intended to describe a part of the lens that is uncolored or colored with translucent coloring.

The term “second shade different from said first shade” (or some similar language) as used herein is intended to mean that both shades are of totally different colors, such as blue and hazel; or that both shades are the same basic color, but having different intensities such as light blue and dark blue.

The term “ordinary viewer” is intended to mean a person having normal 20-20 vision standing about 5 feet from a person wearing the lenses of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a contact lens pattern in accordance with the present invention;

FIG. 2 illustrates a contact lens pattern indicating an outermost starburst in accordance with the present invention;

FIG. 3 illustrates a contact lens pattern indicating an outer starburst in accordance with the present invention;

FIG. 4 illustrates a contact lens pattern indicating an inner starburst in accordance with the present invention;

FIGS. 5A-5C illustrate three contact lens patterns in accordance with the present invention;

FIG. 6 illustrates a contact lens design based on the combination of FIGS. 5A-5C in accordance with the present invention;

FIG. 7 illustrates a contact lens pattern with elements removed from the periphery of the pattern in accordance with the present invention;

FIG. 8 illustrates a contact lens pattern that is not substantially continuous in accordance with the present invention;

FIG. 9 illustrates three contact lens patterns, one of which is not substantially continuous in accordance with the present invention;

FIG. 10 illustrates three contact lens patterns in accordance with the present invention;

FIG. 11 illustrates three contact lens patterns in accordance with the present invention;

FIG. 12 illustrates three contact lens patterns and the combined contact lens design in accordance with the present invention;

FIG. 13 illustrates three contact lens patterns and the combined contact lens design in accordance with the present invention;

FIG. 14 illustrates three contact lens patterns and the combined contact lens design in accordance with the present invention;

FIG. 15 illustrates a three-pattern contact lens design in accordance with the present invention;

FIG. 16 illustrates a three-pattern contact lens design in accordance with the present invention;

FIG. 17 illustrates a three-pattern contact lens design in accordance with the present invention;

FIG. 18 illustrates a three-pattern contact lens design in accordance with the present invention;

FIG. 19 illustrates a four-pattern contact lens design in accordance with the present invention;

FIG. 20 illustrates a three-pattern contact lens design in accordance with the present invention;

FIG. 21 illustrates a four-pattern contact lens design in accordance with the present invention; and

FIG. 22 illustrates a four-pattern contact lens design in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a contact lens 10 in accordance with the present invention. It has a non-opaque pupil section 20 in the center of lens, and an annular iris section 22 surrounding the pupil section. For hydrophilic lenses a peripheral section (not shown) surrounds iris section 22. A colored, opaque, intermittent pattern is located over the iris section 22, as show in FIG. 1. The pattern leaves a substantial portion of the iris section within the interstices of the pattern non-opaque. The non-opaque areas of the iris section 22 appear white in FIG. 1.

The elements of the pattern are preferably dots, and especially preferred are dots, some of which run together, as shown in FIG. 1. Certain portions of the iris section 22 are less densely covered with dots than other portions.

The opaque pattern or patterns can be made up of dots having regular or irregular, uniform or non-uniform shapes, for example, round, square, hexagonal, elongated, or other dot shapes. Further, the elements of the pattern may have a shape other than dots, so long as the elements are undescrinable to the ordinary viewer, cover between 10 and 30 percent, preferably about 20 percent of the iris, and leave a substantial portion of the iris section within the interstices of the pattern non-opaque. The patterns that make up the portions of the iris can be islands of color or worms, corkscrews, starbursts, spokes, spikes, striations, radial stripes, zig-zags and streaks. In certain cases, a single color background is used to complement the multi-pattern design. These patterns blend with each other to provide a colored contact lens that enhances the structure of the iris of a person wearing the lens.

The improvement of this invention is a multiple color pattern that greatly improves the natural appearance of the wearer’s iris, even over that of one and two color lenses. To produce this improvement, three (or more) colored patterns are printed in three or more portions. A first portion of the elements are of a first shade and generally have a greatest concentration of dots or other elements located generally on the outside of, but within, the iris section, i.e. at or near the outer perimeter of the annular iris section. This section may be referred to as the outermost starburst. A preferable first outside portion pattern or outermost starburst is shown in FIG. 2. Black, or some other dark color such as gray, dark-brown or dark blue, is most often used as the color of the outermost starburst.

A second portion (the outer starburst) of the elements are a second shade, which is different from the first shade, and has elements with a greatest concentration located generally on the inside of the outermost starburst, and generally, although not always, surrounded by the outermost starburst portion. A preferable second portion or outer starburst appears in FIG. 3. The outer starburst can be many colors, for example, blue, gray, brown, light blue, turquoise, violet, blue-violet, aqua, yellow or green.

A third portion (the inner starburst) of the elements are of a third shade, which is different from the second shade and either the same or different from the first shade. This third portion has a greatest concentration of elements located generally, but not always, on the inside of the other two portions. Generally, the greatest concentration of elements of the third portion is surrounded by the concentration of elements of the other two portions. A preferable third inside portion pattern or inner starburst appears in FIG. 4. A preferred color for the inner starburst is hazel, but other colors to be used include yellow, yellow-green, brown, yellow-brown, gold and orange. FIG. 1, a preferred embodiment of the present invention, shows a combination of FIGS. 2, 3 and 4.

In a preferred embodiment, a first uneven border differentiates the outermost starburst and the outer starburst portions of the pattern elements, however, the elements of the outermost and outer starbursts overlap, mix and blend together, either in actuality or merely in perception, to create the desired effect. A second uneven border differentiates the outer starburst and the inner starburst portions of the pattern. The elements of the outer and inner starbursts overlap, mix and blend together, either in actuality or in perception. If the patterns of FIGS. 2, 3 and 4 are merged to form a three color lens, the uneven edge of the pattern shown in FIG. 2 will merge and overlap with the pattern shown in FIG. 3 to form the first uneven border between the outermost and outer starbursts. Further, the uneven edge of the pattern shown in FIG. 4 will merge and overlap with the pattern shown in FIG. 3 to form the second uneven border between the outer and inner starbursts.

In certain patterns, the outer starburst may contain pattern that extends further toward the periphery of the lens than the pattern of the outermost starburst. In other patterns, the outer starburst may contain pattern that extends further toward the pupil section of the lens than the pattern of the inner starburst.

Alternative embodiments of the present invention include minimum and maximum distances of the uneven borders from the outer perimeter of the iris section. For example in one alternative embodiment, the minimum distance of the first uneven border from the outer perimeter of the iris section is from about 5% to about 60% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 25% to about 95% of the radial width of the iris section, and the minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 75% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 50% to about 95% of the radial width of the iris section.

In another embodiment, the minimum distance of the first uneven border from the outer perimeter of the iris section is from about 15% to about 50% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 45% to about 95% of the radial width of the iris section, and the minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 65% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 60% to about 95% of the radial width of the iris section.

In yet another alternative embodiment, the outer starburst pattern may extend to the periphery of the iris section of the contact lens, such that some elements that make up the outer starburst are outside of all of the elements that make up the outermost starburst pattern, and/or the elements that make up the outer starburst pattern extend closer to the pupil section such that some of those elements are inside all of the elements of the inner starburst pattern.

In yet another alternative embodiment, the inner starburst pattern creates an interdigitation configuration with either the outermost starburst pattern or the outer starburst pattern or both patterns. Further, the outermost starburst pattern may create an interdigitation configuration with the outer starburst pattern. In an interdigitation configuration, one pattern intersects another similar to the fingers on one hand placed between the fingers on the other hand in a planar fashion.

Another embodiment is made up of a pattern in which at least one of the portions, and preferably more than one, is made up of a pattern or design which consists of elements which are or create uniform and non-uniform dots, islands of color, worms, corkscrews, starbursts, spokes, spikes, striations, radial stripes, zig-zags and/or streaks (see the examples in FIGS. 5-22). Also, a single color may be used as a background in conjunction with the multi-pattern design (see FIGS. 21 and 22). In these designs the portions may be the same, as in FIGS. 15 and 16, or different, as in FIGS. 19, 20 and 21. For example, if the outermost starburst is the same as that of FIG. 2, and the outer starburst is the one shown in FIG. 3, then the inner starburst may be a design in which radial stripes begin at the inner portion of the iris and travel in a radial direction toward the outer periphery of the iris. In this particular embodiment, the remaining multiple portions, whether there are two or more, are made up of a plurality of elements, which may be similar in design to the foregoing portion, combine to leave a substantial portion within the interstices of the pattern non-opaque.

Alternative embodiments include patterns designed such that the greatest concentration of elements having the darkest color or shaded portion are located generally on the outside of the concentration of the elements of the other portions. In particular, the darkest shaded portion has a greater concentration of elements generally located outside the portions with the lighter shaded portions. Another embodiment places the different portions having different shades such that the darkest portion has the greatest concentration of elements generally located on the outside of the other portions, and the next darkest portion has the greatest concentration of elements generally located outside the remaining portions’ elements. This design continues until the lightest shaded portion has the greatest concentration of elements generally located inside all of the other portions.

Another embodiment includes patterns that are not continuous or concentric. In other words, these patterns, which may be of the type listed above, have noticeable non-opaque areas such that when viewed without the other patterns, the non-opaque areas are clearly visible. However, when these patterns are combined with other patterns, the overlapping, blending and mixing of these patterns creates a design that is able to change the apparent color of the iris, while imparting a very natural appearance.

Producing the opaque portions of the iris section is preferably accomplished by printing the lens three times using the known printing process of Knapp’s U.S. Pat. No. 4,582,402, incorporated herein by reference, and the known printing process of Rawlings’ U.S. Pat. Nos. 5,034,166 and 5,116,112, incorporated herein by reference. Generally, a plate or cliche having depressions in the desired pattern is smeared with ink of the desired shade. Excess ink is removed by scrapping the surface of the plate with a doctor blade leaving the depression filled with ink. A silicon rubber pad is pressed against the plate to pick up the ink from the depressions and then is pressed against a surface of the lens to transfer the pattern to the lens. The printed pattern is then cured to render it unremovable from the lens. Of course, either the anterior or posterior surfaces of the lens may be printed, but printing the anterior surface is presently preferred.

Preferred lenses and ink ingredients used to practice this invention are known and described in Loshaek’s U.S. Pat. No. 4,668,240, incorporated herein by reference. The specific ingredients and target weights are described in detail below. Very briefly, a lens constructured of polymer having –COOH, –OH, or –NH.sub.2 groups is printed with ink containing binding polymer having the same functional groups, opaque coloring substance, and a diisocyanate compound. First a solution of binding polymer and solvent is prepared and this solution is mixed with paste containing the coloring substance to form an ink. A preferred binding polymer solutions have a viscosity of about 35,000 CPS for blue, gray, brown and black, and 50,000 CPS for green. The opaque ink is printed and cured on the lens surface.

Ink pastes and pigments that can be utilized in the present invention can be made in a number of different ways using the ingredients and percentages (by weight) as described below in the ink color charts. For example, a hazel ink paste can be made using 63.49 percent binder solution (by weight), 30.00 percent ethyl lactate, 0.61 percent titanium dioxide, 0.06 percent PCN blue, 4.30 percent iron oxide yellow, and 1.54 percent iron oxide red. Although these colors are used for the preferred embodiments, other colors or variations of the weight percentage of ingredients may be used. The charts below are merely a representative example of the possible inks and pigment levels, and is not a complete list. One of ordinary skill in the art could develop other inks and pigment levels that would provide an enhancing effect to the iris of a person wearing the contact lens.

TABLE-US-00001 INK PASTE COLOR CODE BLUE GRAY Total Wt. (g) 600 3000 600 3000 Weight Target Target Weight Target Target Ingredient Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.55 183.30 916.50 30.75 184.50 922.50 Binder Soln 61.15 366.90 1834.50 59.84 359.10 1795.50 PCN Blue 1.21 7.26 36.30 PCN Green 0.23 1.38 6.90 TiO.sub.2 7.09 42.54 212.70 7.34 44.04 220.20 IO Black 1.83 10.98 54.90 Grinding 600 3000 600 3000 Media

TABLE-US-00002 INK PASTE COLOR BROWN HAZEL Total Wt. (g) 651 3000 651 3000 Weight Target Target Weight Target Target Ingredient Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.00 180.00 900.00 30.00 180.00 900.00 Binder Soln 55.10 330.60 1653.00 63.49 380.94 1904.70 PCN Blue 0.06 0.36 1.80 TiO.sub.2 0.61 3.65 18.3 IO Black 5.70 34.20 171.00 IO Red 3.45 20.70 103.50 1.54 9.25 46.20 IO Yellow 4.30 25.80 129.00 IO Brown 5.75 34.50 172.50 Grinding 600 3000 600 3000 Media

TABLE-US-00003 INK PASTE COLOR GREEN BLACK Total Wt. (g) 651 3000 651 3000 Weight Target Target Weight Target Target Ingredient Percent Weight Weight Percent Weight Weight Ethyl Lactate 28.53 185.73 855.90 23.98 156.11 719.40 Binder Soln 63.85 415.66 1915.50 64.04 416.90 1921.20 PCN Blue 0.03 0.20 0.90 IO Black 11.98 77.99 359.4 Cr.sub.2O.sub.3 7.59 49.41 227.70 Grinding 850 4298 850 4298 Media

TABLE-US-00004 INK PASTE COLOR TURQUOISE ORANGE Total Wt. (g) 600 3000 600 3000 Weight Target Target Weight Target Target Ingredient Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.00 180.00 900.00 30.00 180.00 900.00 Binder Soln 58.16 348.96 1744.80 58.00 348.00 1740.00 PCN Blue 0.63 3.78 18.90 PCN Green 2.25 13.50 67.50 TiO.sub.2 8.88 53.28 266.40 IO Red 6.00 36.00 180.00 Carbazole 0.08 0.48 2.40 Violet Hydrophobic 6.00 36.00 180.00 IO Grinding 600.00 5000.00 850.00 4298.00 Media

Of course, alternative ways to form colored opaque elements of the lens may be used. For example, selected portions of the iris section of a wetted hydrophilic lens may be impregnated with a solution of a first substance, such as barium chloride. Then the lens may be immersed in a solution of a second substance, such as sulfuric acid, that forms an opaque, water-insoluble precipitate with the first substance, for example barium sulfate. Thus an opaque precipitate forms within the lens in a predetermined pattern in the iris section. Next all or at least the opaque pattern of the iris section is colored opaque pattern in accordance with the invention. If the entire iris is colored with translucent tint, then the interstices within the pattern will be translucently colored, but still non-opaque and in accordance with a preferred embodiment of the present invention. Optionally, the pupil section of the lens may be colored by a non-opaque tint, because such tint is not visible when the lens is against the dark pupil present in the eye of the wearer. Other alternative opaquing methods include use of a laser (U.S. Pat. No. 4,744,647) and finely ground particles U.S. Pat. No. 4,460,523.

The process of the present invention for making colored contact lenses is as follows. A transparent contact lens comprising at least a pupil section and an iris section surrounding the pupil section is provided.

If the lens is constructed of a hydrophilic material, it also has a peripheral section surrounding iris section. For hydrophilic material, the steps described below are performed with the material in an unhydrated state. Preferred hydrophilic materials are disclosed by Loshaek in U.S. Pat. No. 4,405,773, incorporated herein by reference.

The colored pattern may be deposited onto iris section of the lens in any manner. A currently preferred method is by offset pad printing, described below in some detail.

A plate as (not shown) is prepared having a flat surface and circular depressions corresponding to the desired dot pattern. To make the pattern shown in FIGS. 2, 3 and 4, each depression should have a diameter of approximately 0.1 mm, and a depth of approximately 0.013 mm. The depressions are arranged to cover an annular shape corresponding to that of the iris section of the lens.

The plate may be made by a technique that is well known for making integrated analog or digital circuits. First, a pattern about 20 times as large as the desired pattern is prepared. Next, the pattern is reduced using well-known photographic techniques to a pattern of the exact desired size having the portion to be colored darker than the remaining area. A flat surface is covered by a photo resist material that becomes water insoluble when exposed to light. The photo resist material is covered with the pattern and exposed to light. The portion of the photo resist pattern is removed by washing with water and the resulting plate is etched to the required depth. Then the remainder of the photo resist material is mechanically removed.

Colorant, comprising a pigment and binder or carrier for the pigment is deposited on the flat surface of the plate and scraped across the pattern with a doctor blade. This causes the depressions to be filled with ink while removing excess ink from flat surface. The colorant may be more or less opaque depending on the degree of color change desired. The opacity may be varied by modifying the proportion of pigment to binder in the colorant. A desired affect may be obtained using a highly opaque colorant or by having a somewhat less opaque colorant and covering a greater portion of the iris section surface.

A pad made of silicon rubber, impregnated with silicon oil for easy release, is pressed against the pattern, removing ink from the depressions. The ink on the pad is allowed to dry slightly to improve tackiness, then pressed against the front surface of the contact lens, which deposits the ink in the desired pattern over the iris section. The pad should have enough flexibility to deform to fit over the convex front surface of the lens. For a more natural effect, the printing step may be repeated one or more times using different patterns in different colors, since upon close examination, the iris’s of many persons are found to contain more than one color. The printed pattern need not be absolutely uniform, allowing for enhancement of the fine structure of the iris.

Next the deposited pattern is treated to render it resistant to removal from the lens under exposure to the ocular fluids that the lens will encounter when placed in the eye. The exact method of preventing removal depends on the material of construction of the lens and the pattern. Mere air drying or heating the lens may suffice. For hydrophilic lenses, the techniques for coating the opaque pattern described in Wichterle, U.S. Pat. No. 3,679,504 (incorporated herein by reference), may be used.

The method for manufacturing a colored contact lens generally includes the steps of applying three portions of colorant to the surface of a transparent contact lens and rendering the colorant resistant to removal from ocular fluids. The printed contact lens has a non-opaque pupil section and an iris section surrounding said pupil section with the three portions of colorant. The first portion of colorant, or outermost starburst, is of a first shade, the second portion of colorant, the outer starburst, is a second shade which is different from the first shade, and the third portion of the colorant, or the inner starburst, is a third shade which is different from the second shade and may or may not be the same as the first shade. The outermost starburst may be located such that the greatest concentration of elements of the outermost starburst are located generally on the outside of, but still within, the iris section, and generally on the outside of the concentration of elements of the outer starburst. The greatest concentration of elements of the outer starburst is located generally on the outside of the greatest concentration of elements of the inner starburst, and a first uneven border differentiates the outermost starburst and the outer starburst, although the outermost starburst and the outer starburst potions will overlap. A second uneven border differentiates the outer starburst and the inner starburst, although the outer and inner starbursts overlap. Thus, a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided.

The steps used to deposit the intermittent pattern on the lens surface include using a first plate having depressions corresponding to the first portion or outermost starburst and filling the depressions with colorant of the first shade, preferably black. The next step is pressing a first flexible pad against the first plate and subsequently pressing the first flexible pad against the surface of the lens (either side) thereby printing the first portion of the elements.

The next step involves using a second plate having depressions corresponding to the second portion or outer starburst and filling in the depressions with colorant of the second shade which is different from the first shade, preferably blue, green, gray or brown. The next step is pressing the second flexible pad against a second plate and pressing the second flexible pad against the surface of the lens (either the same or the opposite surface) thereby printing the second portion of the elements.

The final step involves using a third plate having depressions corresponding to the third portion or inner starburst and filling the depressions with colorant of the third shade which is different from the second shade and is either the same or different from the first shade, preferably hazel. Pressing a third flexible pad against the third plate and pressing the third flexible pad against said surface of the lens (either side) thereby printing the third portion of the elements.

Although the steps listed above place an order to the printing of the portions on the lens, the order of printing is not important to the present invention and any other order of printing would be covered by the present invention. Further, the process described above may include the maximum and minimum distances, creating the uneven borders, previously listed in the alternative embodiments.

An alternative embodiment for printing the different layers on the iris section of the contact lens provides for ink-jet printing instead of pad printing of each layer. Ink-jet printing is accomplished without the need of pads or plates and can be administered at a higher resolution than pad printing, thereby providing for greater detail of each colored layer and a more natural final pattern on the iris section of the contact lens.

Using ink-jet printing also reduces the number of devices that make contact either with the contact lens or with other devices. For example, a silicon pad must make contact with a plate or cliche initially and then with the contact lens itself. Contact between the parts tends to wear down the parts, which will then require replacements. During the ink-jet process, the micro-nozzles do not physically make contact with the contact lens, nor with any other device. The chance of the micro-nozzle wearing out is thereby reduced.

Further, the ink-jet printer is electronically controlled such that changing from one color layer to a different color layer can be done easily, by computer control. Thus, once a contact lens design is determined and separated into its multiple colored layers, each layer can be applied to the colored contact lens using an ink-jet process, thereby creating a colored contact lens capable of changing the apparent color of the wearer’s iris.

It can be seen that the present invention provides lenses capable of changing the appearance of the wearer’s iris, while allowing visualization of the fine structure thereof. Various changes may be made in the function and arrangement of parts: equivalent means may be substituted for those illustrated and described; and certain features may be used independently from others without departing from the spirit and scope of the invention as defined in the following claims.

1. An ophthalmic fundus contact lens device for delivering laser photocoagulation energy comprising: (a) a body and anterior surface for positioning the device proximate to the eye of a patient, (b) a disc mounted with central and peripheral reflecting mirrors/prisms to redirect laser energy, (c) a micromotor designed to connect and translate rotational force to the central mirror of said disc, (d) a plurality of mirrors or prisms installed internally in an annular fashion within said body, (e) a lens encased for viewing the posterior segment of the ocular anatomy, (f) a control apparatus to coordinate the sequential firing of the laser with the rotation of the central mirror, whereby said assembly will function to deliver laser energy to the eye fundus.

2. The fundus contact lens in claim 1 wherein said body is a truncated cone.

3. The fundus contact lens in claim 1 wherein said plurality of posterior mirrors/prisms circumscribing a circle are eight in number and contiguous.

4. The fundus contact lens in claim 1 wherein said body contains a posterior flange to facilitate insertion and stabilization under the eyelids.

5. The fundus contact lens in claim 1 wherein the posterior end of said body has a radius of curvature approximating the human cornea.

6. The fundus contact lens in claim 1 wherein said body is composed of plastic.

7. The fundus contact lens in claim 1 wherein said said lens for viewing the posterior segment is concave.

8. The fundus contact lens in claim 1 wherein the micromotor is positioned below the central rotating mirror.

9. The fundus contact lens in claim 1 wherein the micromotor is positioned lateral to the mounted central mirror.

10. The fundus contact lens in claim 1 wherein the mounted disc platform is moveable.

11. The fundus contact lens in claim 1 wherein the micromotor is regulated by a control box.
Contact Lens Description
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to application Ser. No. 11/024,308, filed Dec. 28, 2004 by one of the present inventors and Ser. No. 11/193,735, filed Jul. 29, 2005 and Ser. No. 11/523,437, filed Sep. 19, 2006 by both of the current inventors.

FEDERALLY SPONSORED RESEARCH

Not applicable

SEQUENCE LISTING OR PROGRAM

Not applicable

BACKGROUND OF THE INVENTION–FIELD OF THE INVENTION

The present invention relates to ophthalmic devices which assist in delivering laser therapy to the eye.

BACKGROUND OF THE INVENTION–PRIOR ART

The worldwide diabetic epidemic is a common cause of visual loss. In the United States prevalence estimates among patients with diabetes reveal approximately 40% show some degree of retinopathy. For severe diabetic retinopathy the incidence is at least 8% and probably higher. Diabetic retinopathy leads the way in causing legal blindness for adults 20-74 years of age. Annually there are 12,000-24,000 new cases diagnosed. Furthermore, the degree and severity of retinal disease usually increases with time. From a global standpoint there are currently at least 171,000,000 patients with diabetes. In 2030 it is projected that 366,000,000 will carry the diagnosis.

Both Type I and Type II diabetes put patients at risk for debilitating retinal problems leading to visual loss. Although Type II is about 20 time more prevalent than Type I severe retinopathy appears in both forms. Significant loss of vision is often due to the proliferative manifestation of the illness. In this scenario abnormal new blood vessels, neovascularization, grow on the retinal or vitreous surface of the eye. Subsequent bleeding, leakage, and traction from these aberrant vascular channels damages the retinal tissue resulting in visual loss.

In the 1970′s a large, randomized multicenter controlled trial demonstrated that the proliferative form (severe–stage 5) of diabetic retinopathy was ameliorated by laser therapy. The Diabetic Retinopathy Study (DRS) became the gold standard showing that panretinal laser photocoagulation could reduce visual loss 50-60% in the neovascular form of the disease. This type of treatment is also used in other eye conditions where abnormal vascular proliferation is evident. They would include neovascular glaucoma, central retinal vein occlusion, and branch retinal vein occlusion. In addition, physicians are given the latitude to treat severe non-proliferative diabetic retinopathy with panretinal laser photocoagulation (PRP) in special circumstances.

The three delivery methods currently used to deliver this treatment all require a high degree of operator dexterity. The slit lamp system requires an operator to manually hold a fundus contact lens on the patient’s anesthetized eye, aim an attenuated laser beam shot by shot, and repetitively depress a foot pedal to activate the energy delivery. The indirect ophthalmoscopic format forces the treating surgeon to hand hold a condensing lens in front of the treated eye, align and tilt a headpiece used to direct the laser beam, and fire the spots via a foot switch. Finally, the endoprobe methodology requires an operating room setting and completion of a vitrectomy. In addition, the surgeon must hold the probe in the internal eye and aim it using an operating microscope with an attendant contact lens. While this modality does have a repeat mode for automated laser firing it still necessitates expert user coordination and an operating theatre.

Regardless of the delivery format a full complement of laser treatment (PRP) usually includes 1500-2000 applications placed in a modified checkerboard pattern inside the eye. Multiple patient visits are the norm for completing this treatment. Not uncommonly a full course of therapy will require 60 minutes of patient and physician time. Upon completion of the procedure a ring or donut configuration of laser treatment spots will cause chorio-retinal scarring that improves the clinical course of proliferative retinopathy.

The slit lamp biomicroscope is the most widely used modality for delivering panretinal laser photocoagulation. Mechanically, a laser emitting source is connected via a fiber optic cable to a biomicroscope. The examiner then places an external fundus contact lens on the patient’s eye after topical anesthetic is applied. Using a micromanipulator on the slit lamp the surgeon can focus an attenuated laser on the patient’s retinal surface. After setting the beam size, power, wavelength, and treatment duration the laser can be fired by activating a foot switch. Typically 500 micron diameter laser spots are placed on the retina–one at a time. Primary absorption of the laser energy is by the retinal pigment epithelial cells and the mechanism of action is by thermal heat transfer. Despite over 35 years of applying treatments in this fashion the exact cellular or chemical reaction that mediates the salutary clinical effect is unknown.

The current methods of performing panretinal laser photocoagulation have a number of disadvantages. First, the procedure is time consuming. It usually requires at least two and more often three office visits to complete a full course of therapy. Not uncommonly a full hour of physician and patient time is spent performing the operation. Second, it requires a significant degree of physician coordination and attention to expertly administer treatment. In most cases the examiner must not only carefully focus, aim, and manually trigger the laser but he/she must fire the shots one at a time. Outside of one expensive laser platform currently on the market there is little automation in the procedure. Third, on a regular basis the laser burns cause patient pain. This can necessitate stopping treatments frequently to let the patient rest, it can necessitate administering retrobulbar anesthesia (injecting a numbing agent through the lid behind the globe of the eye), and it can necessitate stabilizing the patient’s eyelids or head to prevent untoward movements during therapy. Finally, the operation has a number of complications. Some of these, such as operator aiming errors, are related to fatigue in either the physician or patient.

A device that would speed up the procedure or reduce the heavy burden of user coordination would be desirable. Furthermore, an invention that would reduce patient pain would be most welcome for all parties. Prior inventions have attempted solving some of these objectives but most have either failed or become oppressively expensive. U.S. Pat. Nos. 6,066,128 and 5,921,981 to Bahmanyar et al. (2000) (1999) address the time burden issue of administering panretinal photocoagulation. Using an optical device to effectuate splitting a single laser into four beams the authors propose a multispot application of laser with each triggering shot. It follows that 500 applications of treatment might produce 2000 spots at the chorioretinal interface. While this methodology may have some merit in reducing treatment times it fails to address problems of user coordination, aiming errors, patient pain, and treatment complications. Their device would still need to be aimed and triggered one shot at a time. Their device might be more painful delivering four simultaneous applications instead of one. And, their device does not lessen the manual dexterity required to provide a full complement of treatment. Finally, panretinal laser complications such as visual field contraction, nyctalopia, and central visual loss are not addressed by their invention.

In another attempt to cut laser treatment times a California corporation, OptiMedica, has employed a pattern-scanning laser system. Named PASCAL, this method cuts treatment times by placing grids or arrays of burns on the patient’s retina with a single triggered application. A twenty five or fifty six spot array can be chosen employing a semi-automated pattern generation display. The shots are delivered in sequence with short 532 nm laser pulses. While laudably cutting conventional treatment times this laser and software package is not likely to find ubiquitous world wide usage. The platform is expensive, large in size, and not easily mobile. It is expected to cost over $75,000/unit.

In U.S. patent application Ser. No. 11/193/735 Eisenberg and Partono (2005) addressed issues of diminishing treatment times, reducing complications, minimizing operator errors, and improving procedure comfort. Their invention acts as a laser beam diverter so that treatment light is placed in a circumferential pattern. The process of panretinal photocoagulation is not only automated by their invention but the cheaper cost of the device will allow for worldwide distribution. With U.S. patent application Ser. No. 11/523,437 the same inventors (Eisenberg and Partono) refined their approach to automating panretinal laser photocoagulation by advancing a device that was even cheaper to build and worked on a different mechanical principle. Interposed between the hardware of a laser delivery device and the patient’s eye their instrument reflects and diverts laser energy by a system of mirrors or prisms. The net effect is to reduce patient therapy times, reduce operators aiming errors, reduce complications of treatment, and reduce patient pain. Furthermore, the invention is mobile, small, adaptable to most conventional laser machines, and relatively inexpensive. Nothing in the current application reduces the efficacy and the viability of the author’s prior devices. However, in the current invention the process is further simplified, the manufacturing cost is reduced, and a new mechanical mechanism is introduced.

BACKGROUND OF THE INVENTION–OBJECTS AND ADVANTAGES

Thus, several objects and advantages of our invention are; a) to provide a device that is highly mobile and portable; b) to provide an instrument that makes the process of panretinal laser photocoagulation faster; c) to provide a method of performing treatment which decreases operator aiming errors; d) to provide an instrument that reduces the pain of PRP; e) to provide a method that minimizes the complications of laser therapy; f) to provide an article of manufacture that reduces the user coordination required to perform laser surgery; g) to provide an adaptation that increases the safety of the procedure; h) to provide an article of manufacture that automates the delivery of panretinal laser photocoagulation.

Further objects and advantages of our invention will become apparent from a consideration of the drawings and ensuing description.

SUMMARY

The current invention is a fundus contact lens device that will assist in automating panretinal laser photocoagulation. It consists of a body or external housing that is designed to be placed on an anesthetized eye. Internally, a disc with holes is mounted with highly reflective peripheral mirrors or prisms to redirect the pathway of laser treatment light. The center of the disc contains a moveable mirror controlled by a micromotor. Rotation of the central reflecting device diverts light to peripheral mirrors which subsequently redirect the treatment beams. A ring of aligned mirrors or prisms at the bottom of the instrument captures the redirected laser energy and deflects it into the internal eye. The invention is regulated via a cable or remotely by a control box.

DRAWINGS–FIGURES

FIG. 1 shows an exploded view of the device from a lateral view. A ring of mirrors and a special lens are seen at the bottom of the instrument.

FIG. 2 shows the top of the fundus contact in side view with laser light redirected by the central mirror and subsequently diverted again by peripheral mirrors.

FIG. 3 shows the fenestrated disc mounted with mirrors or prisms and a micromotor.

FIG. 4 shows the device connected to a control box.

DRAWINGS–REFERENCE NUMBERS

10 external device casing

12 fenestrated disc

14 micromotor

16 holes associated with peripheral mirrors

18 mounted central reflecting mirror/prism

20 peripheral reflecting mirror/prisms

22 external contact lens housing

24 ring of mirrors for internal reflection

26 concave lens and hole

28 entering laser beam

30 control box

32 attachment cable

DETAILED DESCRIPTION–PREFERRED EMBODIMENT–FIGS. 1-4

The preferred embodiment of the invention is shown in FIGS. 1-4. The external housings 10 and 22 of the device are seen in a lateral exploded view in FIG. 1. Laser light 28 from a source is depicted entering the top of the invention. Initially the highly focused energy strikes the angled central mirror or prism that is mounted on a fenestrated disc 12. After reflection the light strikes one of the peripheral mirrors. Again diversion takes place and the energy is redirected to the ring of peripheral mirrors 24 arranged circumferentially toward the base of the instrument. Redirection of the beams ensues and the light passes through a lens 26 and a hole at the bottom of the fundus contact lens into the internal eye. FIG. 2 depicts the top of the invention in a lateral view with more detail. When the laser beam 28 strikes the central mirror 18 it is noted that micromotor 14 lies near the central reflecting surface. It gives the central mirror/prism rotary capacity such that beam diversion will strike each of the peripheral mirrors 20 arranged and mounted circumferentially on a disc 12. A fenestration 16 immediately adjacent to each peripheral mirror allows the energy to pass through the system unimpeded. FIG. 3 shows an enlarged side view of the central disc 12, holes 16, mirrors 18 and 20, micromotor 14 lying below the central mirror along with laser beam 28 passing through the system. FIG. 4 shows the entire fundus contact lens connected to a control box.

Operation–Preferred Embodiment–FIGS. 1,3,4

The method of using the device to perform panretinal laser photocoagulation (PRP) is consistent with known operator techniques in the current art. It is anticipated that a slit lamp biomicroscope and a laser will be used in conjunction with this delivery system. In this scenario the patient’s cornea is usually anesthetized with topical drops. A coupling agent such as methylcellulose is then applied to the base of the fundus contact lens. The lens is then steadied and placed on the subject’s eye. In the preferred embodiment the base of the fundus contact will have an arrangement of circumferential mirrors as delineated by Eisenberg (2004) in U.S. patent application Ser. No. 11/024,308. At that juncture the treating surgeon sets variable laser parameters such as power, spot size, pulse duration, and wavelength. In addition the physician will choose, via a control box 30 (FIG. 4), the speed of central mirror rotation located within the panretinal laser fundus contact lens. It is anticipated that in the preferred manifestation a large diameter laser beam will be employed. Nothing, however, inhibits the device from being used with a varying range of beam sizes. Furthermore, nothing prevents the instrument from being utilized with laser wavelengths outside the conventional (400-700 nm) range.

With the preferred embodiment an examiner will be able to temporarily rotate the central disc 12 (FIG. 1) of the invention to prevent it from blocking the physician’s view of the internal eye. Once the fundus contact is present on the patient’s eye the posterior lens in the device allows the examiner to center the patient’s macula in the primary position. Thereafter, the peripheral mirrors 24 (FIG. 1) in a ring configuration located in the posterior aspect of the instrument can serve to image and focus the peripheral retina. At that juncture the disc 12 (FIG. 1) mounted with mirrors/prisms can be returned to its functional position so that treatment can be started. Activating a trigger switch will then send laser pulses to the central mirror 18 (FIG. 3) close to micromotor 14 (FIG. 3) The laser beam will then be redirected to a peripheral mirror 20 (FIG. 3). After striking this mirror it will again undergo reflection and a directional change. The light will exit the disc through a fenestration 16 (FIG. 3) located beneath each peripheral reflecting device. Upon leaving the disc platform bundles of laser energy will then hit the corresponding mirrors 24 (FIG. 1) within the ring system at the bottom of the fundus contact. Subsequently, they will exit the device through a lens and hole 26 (FIG. 1) at the base of the invention. At that point the energy will be directed to its final target in the internal eye (retinal/choroid). The entire process from the incident beam to the exit beam will be repeated in an automated fashion. Micromotor 14 (FIG. 3) will serve to rotate the mounted central mirror 18. As the central reflecting device moves it will send laser energy to a different peripheral mirror arranged on disc 12 (FIG. 1). Thus, the light will subsequently be diverted to a different mirror at the bottom of the device. Hence, the anatomical target in the retina will change with each fixed, angular rotation of the central mirror. In this fashion a ring of laser applications will be automatically placed within the eye without manually aiming each application. This methodology will not only speed the process of panretinal photocoagulation it will reduce operator errors. In addition, it will reduce the coordination necessary to perform treatment. If a broad laser beam diameter is used for the treatment a complete course of therapy might be reduced to seconds.

Description–Alternative Embodiments

A number of possibilities exist for alternative embodiments of this invention. First, the shape of the external housing of the device in the preferred embodiment is a truncated cone. This is in conformity with most of the current fundus contacts that are commercially available at the present time. However, nothing prevents the device from taking another conformation. It could, for example, easily fit inside a cylindrical body. Second, the mechanism to move the central disc with mounted mirrors so as to allow an examiner to focus on the posterior segment of the eye, has a number of possibilities. In the preferred model the disc is connected to a rod or a wheel that allows the treating surgeon to manually rotate the platform of mirrors. However, this could be achieved electronically without deviating from the spirit of the invention. Furthermore, the internal disc suspending the reflective elements could be hinged to the fundus contact body and swing in and out of place, manually or electronically, at the command of the treating surgeon. Third, the circumferential mirror system at the base of the invention (the last reflective element in the invention prior to the laser light entering the eye) could have a variable number of mirrors/prisms. While the preferred embodiment is drawn with eight the invention could be made six, twelve, or any other number. In addition, the shape of these reflective elements is variable. They might be made as rectangular, semicircular, truncated cones, or triangular. The specific shape of the mirrors is not central to the thesis of the device. Fourth, the regulation of the instrument is depicted with a cable connection to a control box. However, a wireless control might easily be used. Or the electrical circuitry of the laser and biomicroscope might be integrated so as to control the invention. Fifth, one skilled in the art might construct an instrument mimicking the current invention by arranging multiple barrels of laser beams designed to discharge in successive fashion. If the tubes were arranged in a circular fashion and the mirrors of the fundus contact were designed to receive the laser delivery the net result would be analogous to the current device. The successive firing of each laser source or the simultaneous discharges from all would produce a ring of photocoagulation consistent with the current invention. Finally, the position of the micromotor in the device is optional. While the current embodiment is depicted with the micromotor lying below the central reflecting mirror it can easily lie elsewhere. For example, the small motor might occupy a space lateral to the central mirror. It could protrude from the body of the contact lens in an alternative embodiment. In this arrangement it would be connected to the central mirror via a tube or gearing system that would enable it to rotate the central reflecting device. Simultaneously, an examiner might be able to rotate the micromotor and effectuate a repositioning of the central disc with mounted mirrors. From the foregoing discussion it is evident that the exact placement of the micromotor in the device is not critical to the operating principle of the instrument.

Advantages

From the previous description a number of the advantages of our invention become evident: a) The time to complete panretinal laser photocoagulation will be shortened. A rotating laser beam will help automate the treatment process. b) The device will reduce the user coordination involved with the current treatment strategy since the operator will not have to manually aim and trigger each individual application. c) This fundus contact lens will be relatively small and easily portable. Thus, automating a treatment will not require a large hardware platform of heavy and expensive equipment. d) Aiming errors by the treating surgeon will be diminished. The invention will promote the automatic delivery of laser energy to the interior eye without the manual use of a micromanipulator. e) This treatment adaptation will reduce the patient pain associated with panretinal laser therapy. If used either in conjunction with a broad beam laser or with decreased pulse durations the net energy delivered to the retina will be less. This, along with faster delivery times, will minimize patient discomfort. f) Enhanced safety will result from the instrument. Speeding and automating the process of panretinal laser treatment will result in less fatigue for the patient and the surgeon. Furthermore, it will cut the incidence of misdirected laser energy due to operator errors. g) The complications of panretinal laser surgery will be reduced. If less energy is delivered to the eye the side effects of current treatments should be less. This would include untoward results such as visual field contraction, contrast sensitivity reduction, and nyctalopia. It is even possible macular edema might be lessened by our invention. h) The apparatus will assist in automating a process which is heavily burdened with manual input.

CONCLUSIONS, RAMIFICATIONS, SCOPE

Thus, the reader will see that a specialized fundus contact lens can be used to provide a faster and safer method for performing panretinal laser photocoagulation. This is accomplished by diverting laser light energy within an instrument that is held on the eye during treatment. By mechanically rotating a central mirror that receives laser energy the light can be redirected to mounted peripheral mirrors/prisms which divert the energy in a circular configuration. In this fashion an annular ring of photocoagulation can be delivered to the internal eye. The effects of the invention will be to speed the process of treatment, to reduce patient pain, to reduce operator fatigue, to minimize aiming errors, and to minimize the complications of the procedure.

The above description contains many specificities and these should not be construed as limitations on the scope of the invention. Instead they should be seen as exemplifications of the preferred embodiment. Many variations are possible aside from the ones previously discussed. For example, a rod or cylindrical attachment might extend from the body of the contact lens and connect to the mirror mounted disc. This might facilitate rotating or moving the reflective platform so that the examiner could use the posterior lens in the contact to view the internal eye. Alternatively, the plate of mirrors might exist in a configuration that allows it to be removed entirely from the interior of the fundus contact. Then subsequent reinsertion, after checking the patient’s eye position, would allow therapy to proceed.

It is apparent that the scope of the invention should be determined by the appended claims and their equivalents.

1. A soft contact lens comprising: a disc-shaped body having a central portion selectively providing visual correction when worn by a person; a fluid reservoir having an opening and holding a fluid, said fluid reservoir being collapsible and being formed in said body away from said central portion and positioned to be selectively pressurized and depressurized by the person’s eye lid as the person gazes downward and forward, causing said fluid reservoir to collapse when pressurized causing the fluid to exit through said opening, said fluid returning to said fluid reservoir when said fluid reservoir is depressurized; and a chamber with a micro-channel disposed in said central region and being in communication with said fluid reservoir through said opening, said chamber being selectively filled with said fluid as said fluid reservoir collapses, said micro-channel being arranged and constructed to change the optical characteristics of the lens by changing the curvature of said central region in response to changes in the pressure of said reservoir.

2. The lens of claim 1 wherein said lens body is changed by said micro-channel between said first and second shape by selectively steepening or unsteepening said shape.

3. The lens of claim 1 wherein said liquid has the same index of refraction as the lens body.

4. The lens of claim 1 wherein said liquid has an index of refraction different from that of the lens body.

5. The lens of claim 1 wherein said lens body is adapted to change shape in response to a squeezing action from the eyelids of a wearer.

6. The lens of claim 1 further comprising a diaphragm positioned to transmit pressure between said reservoir and said chamber.

7. A soft contact lens comprising: a round lens body having a central zone defining a visual axis through which a wearer is gazing when the lens body is disposed in an eye, and a lower portion; a reservoir formed within the lower portion to hold a fluid; and a chamber disposed in said central zone and including at least one microchannel in fluid communication with said reservoir, said reservoir and said chamber cooperating with said lens body to provide the lens with one of a first optical characteristic and a second characteristic along said visual axis, based on the relative amount of fluid in said reservoir and said chamber; wherein said body is made of a soft material causing said reservoir to collapse when the wearer gazes downward caused by the eye lid applying an inward pressure on the reservoir causing some of said liquid to flow from said reservoir to said chamber.

8. The soft contact lens of claim 7 wherein said chamber is adapted to selectively steepen or unsteepen the curvature of the lens as said fluid is transferred between said chamber and said reservoir.

9. The soft contact lens of claim 8 wherein said fluid has the same index of refraction as said lens body.

10. The soft contact lens of claim 7 wherein said fluid has a different index of refraction then said lens body.

11. The soft contact lens of claim 10 wherein said visual axis passes through said first section and wherein when said first section is filled with liquid, said lens body and said reservoir cooperate to form a multi-lens path along said visual axis including a back portion of said lens body, said first section and a front portion of said lens body.

12. The soft contact lens of claim 10 wherein said visual axis passes through said first section and wherein when said first section is filled with liquid, said lens has an optical power that is primarily dependent on the optical characteristics of said fluid.

13. The lens of claim 7 wherein said lens body is adapted to respond to a wiping action of the wearer eyelids, said wiping action providing pressure on said lens body to cause liquid to shift between said reservoir and said central zone.

14. The lens of claim 7 wherein said lens has a front and a back surface and said microchannel has a first surface and a second surface, said first surface being disposed closer to said front then to said back surface, said first surface being inflated by said fluid to cause a portion of said front surface corresponding to said central zone to bulge outwardly to increase the diopter of said lens.

15. The lens of claim 14 further comprising a plurality of microchannels, said microchannels being inflated by said fluid to change the diopter of said lens.

16. The lens of claim 15 wherein said microchannels are arranged in parallel to each other.
Contact Lens Description
RELATED APPLICATIONS

This application is related to copending U.S. application Ser. No. 11/326,261 filed Jan. 5, 2006 entitled Hydrodynamically Operated Multifocal Contact Lens, now pending; and to copending U.S. application Ser. No. 11/689,595 filed on Mar. 22, 2007 entitled “Manufacturing Techniques for Production of Hydrodynamic Multifocal Contact Lenses”, now pending, all incorporated herein by reference.

BACKGROUND OF THE INVENTION

a. Field of the Invention

This invention deals with the art of vision correction through the application of a soft contact lens to the human eye. More particularly, this invention details a novel method to dynamically alter the optical characteristics of a soft contact lens by changing the shape of the lens using a fluid disposed therein.

b. Description of the Prior Art

The human eye contains two main tissues or elements that act to focus light onto the retina. The cornea, which is the clear, watch crystal-like tissue on the outside of the eye, focuses light coming from distant objects. The ability to see distant objects is referred to herein as distance vision.

The other tissue or element is the crystalline lens on the inside of the eye (i.e., disposed radially inwardly from the cornea) that performs the Afocusing necessary to clearly image objects closer than approximately 20 feet, hereinafter referred to as near objects or near vision. The lens consists of concentric layers of protein arranged like an onion. In many people, and typically as a person ages, the lens gradually thickens and becomes less pliable. By the age of around 40, many people experience a condition known as presbyopia, which is characterized as a decreased ability to focus on near objects resulting from this thickening of the lens.

Historically, presbyopia has been addressed by prescribing spectacle lenses or glasses. These glasses are available in two forms: as reading lenses and, for people who have additional vision deficiencies such as myopia, as multifocal lenses. Reading glasses are appropriate to correct near vision. Their disadvantage is that a wearer must remove them in order to see clearly at distance. Glasses with multifocal lenses, including bifocal and progressive lenses, address both distance and near vision. These types of lenses provide correction by having lens portions with different focal points. Generally, an upper portion of the lens is adapted to correct for distance vision while a bottom portion is adapted for near vision. The person wearing the glasses adjusts their head so that they can gaze through the top portion to see far objects. In order to see near, they would keep their head as if they were looking at a distance then rotate their eyes downward so that they can gaze through the bottom portion in order to clearly focus on near objects. By changing the position of the eyes in the eye sockets, the wearers align their optical axes with different portions of the lenses. Multifocal lenses, including trifocals and progressives, may have additional portions to provide accurate focusing for objects at various intermediate distances from a wearer.

Some forty years ago, contact lenses (or contacts) started to be used as a common alternative to glasses to address both distance and near blurred vision. Two types of contact lenses are presently in use: Rigid Gas Permeable or hard contact lenses, and soft contact lenses. Hard contact lenses to correct distance vision generally are fit to partially rest under the upper lid and move with the lid during the blink. Translating bifocal hard contact lenses provide for correction for both distance and near vision, but work somewhat differently in that the lower edge of the contact rests against the lower lid so that as the wearer’s gaze changes from a distant to a near object, the lens stays stationary at the lower lid while the eye rotates downward and gazes through the near vision portion of the contact. As a result, similar to glasses, as wearers move their eyes downward, they align their optical axes with different portions of the corrective hard contact lenses.

Soft contact lenses on the other hand drape on the cornea like a wet tee shirt and therefore remain essentially in the same location with respect to the optical axis of the eye, even during the blink. As a result, even as an eye moves, the contact lens effectively moves with it; therefore it effectively remains fixed relative to the eye’s optical axis. This constant positioning insures that the optical axes of the contact lens and the natural lens of the eye coincide.

Such an approach presents a problem when one wants to create a bifocal soft contact lens because, no matter the direction of gaze, the visual axis of the eye always passes through the same portion of the lens. This problem is currently addressed by a contact lens that contains multiple refractive surfaces disposed directly along the visual axis. Examples of designs used for this purpose include aspheric, diffractive, concentric power rings, and refractive islands. All of these designs focus light coming from different distances onto the retina simultaneously. However, these designs all can result in “double or triple exposures” on the retina and can significantly degrade the quality of the retinal image, making such lenses unattractive to portions of the population. Therefore there is a need for an effective and user friendly multifocal contact lens.

SUMMARY OF THE INVENTION

As discussed above, as the eyeball moves, the optical axis of a soft contact lens and the natural lens remain substantially coincident. Therefore, providing a contact lens having different refractive powers along different optical axes (as is the case with multifocal glasses) does not provide a solution to the problem of most patients. The present invention provides a solution to this problem by providing a lens that changes its optical characteristics (e.g., magnification power, its focal length, and/or refractive power) dynamically and in situ. In particular, a soft contact lens is disclosed that includes a cavity with one or more flexible internal chambers arranged at or near the optical axis of the eye, and one reservoir initially filled with a fluid. Movement of the eye causes the fluid to selectively move between the reservoir and the cavity in a manner designed to provide in situ changes to the optical characteristics of the soft contact lens. Preferably, the fluid is selected so that it has the same characteristics as the material of the lens to avoid any internal reflections. Typically, the fluid may be a silicone oil or saline solution.

According to one embodiment of this invention a contact lens includes a reservoir filled with fluid. For distance viewing, the bulk of the fluid generally remains outside the wearer’s optical axis. The reservoir is constructed and arranged so that it undergoes compression by the natural force of apposition of the lid applied to the eye itself during downward gaze. This compression forces fluid to move from the reservoir and into the internal chambers, thereby dynamically changing the shape of the lens, and thereby dynamically altering the optical characteristics of the contact lens. Conversely, when the wearer looks up the lens rides up from behind the lower lid thereby releasing the compression forces from the lid, allowing the fluid to return to the reservoir, thereby allowing the lens to return to its natural shape which is configured for distance vision. Thus, as described above, advantageously, in the present invention it is the position of gaze that determines the contact lens’s optical characteristics in the field of vision. More specifically, the further the eye is in downward gaze the greater the change in the characteristics. Preferably, a downward gaze gradually changes the lenses focal point from the eye’s distance vision to the eye’s near vision. In effect this creates a continuous variable multifocal contact lens. This can be accomplished through using fluid pressure to reshape; squeeze the lens; or a combination of the above.

These principles may be used to provide other optical configurations as well. More specifically, the lens is constructed so that this wiping action of the lids causes a fluid within the reservoirs to shift toward or away from a subject’s axis of gaze, thereby causing a corresponding change in the optical characteristics of the lens relative to the wearer’s gaze. The movement of the fluid, or reshaping of the cavity, changes the optical characteristics of the lens, adjusting for the correction required for the user.

The use of a plurality of chambers, which can change shape through associated fluid movement responsive to nominal eyelid pressure, permits substantial changes in the optical characteristics of the lens. The dimensional changes occurring to the contact lens have designed features that would allow maximum refractive changes under minimum lid pressure while maintaining lens position and comfort. These features increase the range of patients able to gain benefit from reservoir lenses, especially considering that the pressure of lid apposition to the eye decreases with age. This invention also broadens the population of potential beneficiaries to include emmetropic presbyopes (individuals who only need correction for reading and not for distance) but whose eyelid pressure is insufficient for the reservoir lenses in the prior art as seen in Hydrodynamically Operated Multifocal Contact Lens. This invention is beneficial to this population because current products diminish the clarity at distance, which makes those designs unacceptable to individuals who otherwise have clear distance vision.

In another embodiment, the contact lens includes an internal cavity made up of a single reservoir combined with multiple chambers, or micro-channels or micro-tubes to allow for multiple small base cure changes instead of one large base curve change, thereby easing pressure required for fluid movement. Fluid exchange can be avoided completely by creating a diaphragm covering the base of the micro-channels leading into the optic zone. The diaphragm allows fluid pressure to be exchange between the peripheral reservoir and the central micro-channel optic zones without any fluid exchange, thereby eliminating contamination risks.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the placement of a lens constructed in accordance with this invention over an eye;

FIG. 2A shows a first embodiment of the lens;

FIGS. 2B and 2C show a cross-sectional view of the lens of FIG. 2A in a deflated condition;

FIGS. 2D and 2E show a cross-sectional view of the lens of FIG. 2A in an inflated condition;

FIG. 2F shows a second embodiment of the lens;

FIGS. 2G and 2H show a cross-sectional view of the lens of FIG. 2F in a deflated condition;

FIGS. 2I and 2J show a cross-sectional view of the lens of FIG. 2F in an inflated condition;

FIG. 2K show comparative side sectional views of the lens in FIGS. 2H and 2J;

FIG. 3A shows a side view of an eye gazing forward with the lens of FIGS. 2F-2I;

FIG. 3B shows the eye of FIG. 3A glancing downward

FIG. 4A shows a side view of a lens conforming to a fourth embodiment of the invention;

FIG. 4B shows a cross-sectional view of the lens of FIG. 4A with the micro-channel deflated;

FIG. 4C shows a front view of the lens of FIG. 4B;

FIG. 4D shows a view similar to the one in FIG. 4A with the eye gazing downward;

FIG. 4E shows a cross-section of the lens of FIG. 4B with the micro-channel inflated;

FIG. 4F shows a front view of the lens of FIGS. 4D and 4E.

DETAILED DESCRIPTION OF THE INVENTION

Once a traditional soft contact lens is appropriately placed into the eye, it will maintain its position and stay aligned in relation to various optical elements, including the cornea, pupil and crystalline lens, no matter in which direction a person gazes. In other words, as a wearer looks, up, down or sideways, the optical axis of the contact lens will stay aligned relative to the optical axis of the eye. This constant positioning allows for the coupling of the power of the contact lens with the power of the visual axis of the eye. This in turn allows the contact lens to neutralize the excess or deficiency in refractive power of the eye. This is the basis for distance vision corrective contacts. Unfortunately it only addresses a single focal distance. For individuals, over the age of 40, who have lost the dynamic focusing power the crystalline lens, this type of contact lens is no longer sufficient.

This present invention takes advantage of this central positioning phenomenon by providing a multifocal lens having selectively changing optical characteristics along the same optical axis. More specifically, a soft contact lens is disclosed that changes its optical characteristics dynamically in response to gaze dependent pressure fluctuations induced by the eyelids relative to one or more reservoirs of fluid contained inside the contact lens. The following examples illustrate the various embodiments of the invention.

An eye 30 is shown in FIG. 1, with pupil 32 and two eye lids (with only the lower lid 34 being shown for the sake of clarity). The active region of the eye, e.g., the region through which a person sees, is denoted by the circle 18. A contact lens 10 constructed in accordance with this invention is disposed on the eye.

As shown in FIGS. 1 and 2A the contact lens 10 has an upper section 12 that has the same optical characteristics as a traditional soft contact lens, which may or may not optically correct for distance, and a lower section 14 that is formed with a reservoir 16. This reservoir 16 is shaped somewhat like the letter D facing downward. The reservoir 16 is connected to an upwardly extending circular chamber 20 projecting over the center of the contact lens and region 18. The reservoir 16 is filled with a fluid 22. When a person wearing contact lens 10 looks down, the eyelid 34 presses on the reservoir 16 causing some of the fluid 22 to flow upward into chamber 20 thereby inflating the chamber.

FIGS. 2B and 2D show the cross section of the lens through the chamber 16, with the chamber 16 being deflated and inflated, respectively. FIGS. 2C and 2E show a lens equivalent to each of the configurations of FIGS. 2B and 2D. As can be seen in these figures, as a result of the inflation, the physical characteristics and curvature of the equivalent lenses increases dramatically when the chamber 20 is inflated.

A second embodiment of the invention is shown in FIGS. 2F-2K. In this embodiment, the chamber 20 consists of a plurality of linear micro-channels 21 that extend across a substantial portion of section 18 of the eye and are in communication with the reservoir 16. When the contact lens 10 is placed into an eye 30, the reservoir 16 is disposed below the visual axis that passes the pupil 32. The reservoir 16 is filled with fluid, such as saline solution, contact lens lubricant, artificial tears or other non-toxic material such as liquid silicone or even an un-polymerized contact lens monomer. This fluid can be chosen to have refractive indices similar to, higher, or lower than the contact lens polymer, in order to effect the optical properties selected to provide near vision correction. Upon insertion, the weight of the reservoir causes the lens to take the position shown in the figures, i.e., with the reservoir disposed at the bottom portion of the lens.

When a wearer gazes straight forward for distance vision, he is looking along an optical axis X-X that passes through chamber 20. In this position, the fluid is primarily disposed in the reservoir 16 as shown in FIGS. 2F and 3A. In this position, the micro-channels 21 are non-pressurized or deflated as shown in FIGS. 2G and 2H. As a result, the portion of the lens 10 through which the wearer is gazing is configured either to provide distant vision correction or provides no optical effect.

To adjust to near vision, the wearer lowers his eye so that the axis of vision X-X is now disposed at a downward angle relative to the horizontal plane. As the eye ball rotates to this position, the eye lid 34 applies an upward pressure to the fluid 22 in the reservoir 16 causing the fluid to rise, thereby filling and expanding the micro-channels 21 of chamber 20, as shown in FIGS. 2I and 2J. The micro-channels 21 are sized and shaped to cause the lens 10 to become more convex thereby generating steeper base curve and causing a gradual shift in the optical characteristics of the contact lens. (The term `steepen` is a term of the art and it relates to a distortion of a lens that causes the lens to become more convex.)

In other words, as shown in FIG. 2K, the lens 10 changes from a configuration shown on the right as having a low curvature to a configuration with a much higher curvature.

Advantageously, the process produces a gradual, rather than a sudden shift between far and near sight correction by changing the curvature of the lens 10.

To return to distance vision focus, the wearer looks up, thereby removing the pressure of apposition from the lid 34 on the reservoir 16, allowing the fluid 22 from each micro-channel 21 to flow down and return to the reservoir 16. This action is further assisted by the upper lid (not shown), which acts as a squeegee on the micro-channels 21 (utilizing the same “force of apposition” during a blink), causing the upper section of the reservoir to empty back into the lower portion of the reservoir. This action re-flattens the distended outer surface base curve in the optical section 18 of the contact lens 10 thereby returning the contact lens to distance vision.

In the embodiments of FIGS. 2A-2K, the lens shell formed of sections 12 and 14 and the liquid in the reservoir may have the same index of refraction, e.g., 1.4. Therefore even when the liquid is squeezed upward into chamber 20, the various elements of the contact lens 10 cooperate effectively to form a single lens along axis 18.

Alternatively, a fluid having an alternate index is used to further enhance the refractive change of the lens, thereby providing further multifocal capability. That is, depending the depth of gaze, the overall index changes from a combination composed mostly of the contact lens section 12 and a little refractive fluid in the chamber 20 to a combination formed of the contact lens and more refractive fluid in chamber 20. In this arrangement, the lens changes gradually from a configuration having optical characteristics dominantly for myopia (or other non-presbyoptic) correction to a configuration dominantly for presbyoptic correction while concurrently providing gradual change in myopic or other non-presbyoptic correction. This in turn creates a gaze dependent multifocal contact lens via in situ alteration of the refractive index (or the contact lens’ optical characteristics).

In a third embodiment of the invention, the micro-tubules 21 are not in direct communication with the reservoir 16 but are sealed like many small linear balloons with a flexible ends or diaphragms 24 (shown in FIGS. 3A, 3B) and contain a liquid 22A. These diaphragms are made of the same material that the micro-tubules are made of and are arranged so that when the wearer is gazing forward, the diaphragms are either relaxed (e.g. flat) or they bulge slightly downward to allow the micro-tubules 21 to flatten. When the wearer gazes downward, some of the fluid 22 flows upward causing the diaphragm to bulge upward and expand the micro-tubles 21 as shown in FIG. 2I. This embodiment is advantageous because the liquid from the reservoir 16 is separated from the liquid in the micro-tubules 21 thereby preventing cross-contamination which may cause optical hazing and therefore blurred vision. Moreover, the fluid in the chamber 20 and its micro-channels 21 could have a different index of refraction then the liquid in reservoir 16.

FIGS. 4A-4F show a fourth embodiment of the invention. This embodiment also includes a reservoir 16 disposed at the bottom of contact lens 10 and having about the same size and shape as in the previous embodiments. However, the upper chamber 20 includes one or more annular micro-channels 11 encircling a sealed optic zone 19. The optic zone 19 is filled with a liquid, a gel, or a flexible solid and can exchange fluid or fluid pressure (through an appropriate diaphragm) from the reservoir 16 in the manner described for the other embodiments. When a wearer gazes forward for distance vision, the wearer looks along an optical axis that passes through section 19. In this position, the fluid in the surrounding ring 11 is primarily or totally disposed in the lower portion of the reservoir 16 as shown in FIGS. 4A and 4C causing the circumferential ring to be in a non-expanded or deflated state. In this configuration, the portion of the lens 19 through which the wearer is looking is configured to provide either no optical effect on the wearer’s vision or to provide distant vision.

In order to change the contact lens to near vision correction, the eye is lowered, and the pressure of the lower lid 34 on the contact lens 10 causes the fluid in the reservoir 16 to rise, thereby filling and expanding the micro-channels 11 surrounding section 19, as shown in FIGS. 4D-4F. In other words, the lower lid 34, which normally applies pressure directly to the eyeball during downward gaze, now is used to compress the reservoir and force the fluid up into the circumferential micro-channel or ring 11. As a result, central optic zone 19 is inwardly compressed and deformed to a steeper base curve or a more convex lens surface causing a shift in the optical characteristics of the contact lens (see FIGS. 4D-4F). Advantageously, the depth of downward gaze defines the optical characteristic of the contact lens and will therefore dictate the progression of optical change in relation to that of the downward gaze. This creates a gaze dependent multifocal contact lens via in situ alteration of the base curve.

To return to distance vision focus, the wearer looks up, moving the contact lens up away from the lower lid 34, thereby releasing the pressure on the lower reservoir and allowing the fluid from the micro-channels 11 to flow back down into the peripheral reservoir 16. This action removes any deforming pressure on the central optic zone 19. This action is further assisted by the upper lid 36 which acts as a squeegee (utilizing the same “force of apposition” during a blink). This flattens the distended center optic zone 19 returning the focus to distance.

The preceding sections are a general description of how hydrodynamic forces can be employed to alter the refractive nature of a contact lens. It is not meant to be an exhaustive or limiting only instructive on the general implementation of fluid dynamics to induce refractive changes in a contact lens. To anyone skilled in the art many variations or combinations can easily be envisioned or applied to this invention without departing from its scope as defined in the appended claims.

1. A contact lens blister package, comprising: a thermosplastic base member comprising a light collimation cavity having a liquid and a contact lens present in the light collimation cavity, and a flange extending outwardly from the light collimation cavity, the flange including a sealing area to which a sealing member can be attached to seal the contact lens and the liquid in the cavity; wherein the light collimation cavity comprises a bottom surface having a bottom surface perimeter, and an upwardly extending cavity sidewall surface extending form the bottom surface perimeter to an upper perimeter cavity edge defining a light collimation cavity perimeter, and wherein the light collimation cavity perimeter is greater than the bottom surface perimeter; and wherein the light collimation cavity bottom surface has a radius of curvature at least 200% larger than a base curve of the contact lens.

2. The package of claim 1, wherein the cavity sidewall extends from the planar flange region toward a central region of the light collimation cavity at an angle from about 80.degree. to less than 90.degree..

3. The package of claim 2, wherein the base member further comprises a proximal end region having a thumb grip region, an opposing distal end region substantially opposing the proximal end region, a first side region extending from the proximal end region to the opposing distal end region, and an opposing second side region extending from the proximal end region to the opposing distal end region and substantially opposing the first side region, wherein the light collimation cavity is located between the proximal end region and the opposing distal end region, and between the first side region and the opposing second side region.

4. The package of claim 3, wherein the base member has a length extending form the proximal end region to the opposing distal end region, and a width extending from the first side region to the opposing second side region, and the light collimation cavity has a cavity length parallel to the base member length and has a cavity width parallel to the base member width, wherein the cavity length is greater than the cavity width.

5. The package of claim 4, wherein the cavity sidewall has a proximal sidewall portion positioned closer to the proximal end region of the base member than to the opposing distal end region of the base member, the proximal sidewall portion having a shallower slope compared to a more distal portion of the cavity sidewall.

6. The package of the claim 5, wherein the light collimation cavity perimeter is substantially egg-shaped with the narrowest portion of the perimeter being located closer to the proximal end region of the base member than to the opposing distal end region of the base member.

7. The package of claim 1, wherein the contact lens is fully immersed in the liquid.

8. The package of claim 1, wherein the liquid is a buffered saline solution.

9. The package of claim 1, wherein the contact lens is a silicone hydrogel contact lens.

10. The package of claim 1, wherein the contact lens is a daily disposable contact lens.

11. The package of claim 1, wherein the contact lens remains substantially centered in the cavity when the package is placed on a horizontal surface with the cavity opening facing up.

12. The package of claim 1, wherein the liquid includes a surfactant.

13. The package of claim 1, further comprising a sealing member removable attached to the sealing area of the flange thereby forming a sealed enclosure containing the liquid and contact lens.

14. The package of claim 1, wherein the base member is an injection molded polyolefin material.

15. The package of claim 1 coupled to tat least one other identical package to form an array of lens packages.

16. A contact lens blister package, comprising: a thermosplastic base member comprising a liquid and a contact lens located in a light collimation cavity defined by a bottom wall surface having a perimeter, and a sidewall surface extending from the bottom wall surface perimeter upwardly toward a flange extending outwardly from the cavity, wherein the cavity has a maximum length of about 25 mm and a maximum width of about 20 mm, and the bottom wall surface has a radius of curvature of at least 200% larger than a base curve of the contact lens.

17. The package of claim 16, wherein the bottom wall surface is a surface of a cavity bottom wall, and the cavity bottom wall has a thickness less than 1 mm.

18. The package of claim 17, wherein the cavity bottom wall thickness is about 0.8 mm.

19. The package of claim 16, wherein the cavity has a maximum depth of about 7.0 mm.

20. The package of claim 16, wherein the sidewall surface comprises a proximal sidewall portion, a distal sidewall portion, a first lateral sidewall portion, and a second lateral sidewall portion opposing the first lateral sidewall portion, at least one of the distal sidewall portion, the first lateral sidewall portion, and the second lateral sidewall portion is oriented at an angle of about 5 degrees from a straight line extending from, the bottom wall surface and perpendicular to a top surface of the flange.

21. The package of claim 16, wherein the base member further comprises a proximal end region grippable by fingers of a person, the proximal end region comprising a first surface continuous with a top surface of the flange, and a plurality of raised bumps extending form the first surface.

22. The package of claim 21, wherein the proximal end region further comprises a gate recess projecting from the first surface.

23. The package of claim 21, wherein the proximal end region further comprises indicia selected from the group consisting of numbers, letters, graphics, and combinations thereof.

24. The package of claim 16, wherein, the flange has a maximum width of about 3 mm.

25. The package of claim 16, wherein the base member has a maximum width of about 27 mm, and a maximum length of about 46 mm.

26. The package of claim 16, wherein the contact lens is fully immersed in the liquid.

27. The package of claim 26, wherein the liquid is a buffered saline solution.

28. The package of claim 26, wherein the liquid comprises a surfactant.

29. The package of claim 26, wherein the contact lens is a silicone hydrogel contact lens.

30. The package of claim 16, wherein the contact lens is a silicone hydrogel contact lens.

31. The package of claim 16, wherein the contact lens is a daily disposable contact lens.

32. The package of claim 16, wherein the contact lens comprises a polymer of hydroxyethyl methacrylate and a phosphoryl choline derivative.

33. The package of claim 16, further comprising a removable sealing member coupled to the flange.

34. The package of claim 16 coupled to at least one identical package to form an array of lens packages.

35. The package of claim 34 which is present in an array of three lens packages.

36. The package of claim 34 which is present in an array of the five lens packages.

37. A contact lens blister package, comprising a thermoplastic base member having a length and a width, the base member comprising: only one cavity to retain a liquid composition, the only one cavity being noncircular, having a bottom wall surface and a sidewall surface extending perimetrically from the bottom wall surface; a liquid and a contact lens in the cavity; and a flange outwardly extending from the only one cavity, wherein the bottom wall surface has a radius of curvature from about 15 mm to about 26 mm along the length of the base member and along the width of the base member, and wherein the radius of curvature is about 200% greater than a base curve of the contact lens, and the bottom wall surface is configured to collimate light.

38. The contact lens blister package of claim 37, wherein the bottom wall surface is a surface of a bottom wall having a thickness of about 0.8 mm.

39. The contact lens blister package of claim 38, wherein the radius of curvature is from about 25 mm to about 26 mm.

40. The contact lens blister package of claim 38, wherein the cavity has a maximum depth of about 7 mm.

41. The contact lens blister package of claim 38, further comprising a proximal finger grippable region, and wherein the cavity comprises a proximal end in proximity of the proximal finger grippable region, and an opposing distal end, the proximal end having a width that is less than a width of the distal end.

42. The contact lens blister package of claim 37, wherein the contact lens is a silicone hydrogel contact lens.

43. The contact lens blister package 37, further comprising a support rib depending from the flange and spaced apart from the cavity.

44. A method of inspecting a hydrated contact lens, comprising: providing a contact lens in a liquid present in a light collimation cavity of a contact lens blister package, wherein the light collimation cavity has a bottom wall surface having a radius of curvature from about 15 mm to about 26 mm along a length of the cavity and along a width of the cavity; directing partially collimated light through the light collimation cavity, and liquid and contact lens provided therein, to produce fully collimated light; and obtaining a bright field image of the contact lens using a camera receiving the fully collimated light.

45. The method of claim 44, wherein the method is simultaneously performed on a plurality of contact lens packages.

46. The package of claim 37, further comprising a removable sealing member coupled to the flange.
Contact Lens Description
FIELD

The embodiments described herein relate to contact lens blister packages and methods of inspecting hydrated contact lenses using the blister packages.

BACKGROUND

The manufacture of ophthalmic lenses, such as contact lenses, includes inspecting lenses for defects and packaging the lenses in packages, among other things. In the production of large amounts of ophthalmic lenses, such as contact lenses, it is desirable to continue to develop new manufacturing components, systems, methods, and the like to reduce production time, to reduce production costs, and to increase productivity, among other things.

SUMMARY

A contact lens blister package, or a thermoplastic base member of a contact lens blister package, comprises a cavity dimensioned to accommodate a hydrated contact lens, and a flange outwardly extending from the cavity. When the package or base member is used to hold a hydrated contact lens during a lens inspection procedure, the cavity can be understood to be a light collimation cavity. Methods of inspecting contact lenses comprise using the blister packages or the thermoplastic base members.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an array of sealed contact lens packages.

FIG. 2 is a perspective view of a single sealed package of the array of FIG. 1.

FIG. 3 is a perspective view of the package of FIG. 2 with the sealing member partially removed.

FIG. 4 is a perspective view of an array of unsealed contact lens packages.

FIG. 5 is a top plan view of one unsealed contact lens package.

FIG. 6 is a sectional view of the package of FIG. 5 along line 6-6.

FIG. 7 is a sectional view of the package of FIG. 5 along line 7-7.

FIG. 8 is a side plan view of the package of FIG. 5.

FIG. 9 is an illustration of a portion of an ophthalmic lens inspection system including the present packages.

FIG. 10 is an illustration of a portion of an ophthalmic lens inspection system in which partially collimated light is collimated by the bottom wall of the package cavity, the ophthalmic lens, and the liquid present in the cavity.

FIG. 11 is a side plan view of another contact lens package.

DETAILED DESCRIPTION

Referring to FIG. 1, an array 70 of a plurality of contact lens packages 10 is illustrated. The illustrated array 70 consists of four contact lens packages 10. Another array may consist of two contact lens packages. Another array may consist of three contact lens packages. Another array may consist of five contact lens packages. Additional arrays of packages may comprise more than five contact lens packages.

In the array 70, a contact lens package 10 is positioned adjacent at least one other contact lens package 10. For example, contact lens package 10a is adjacent one contact lens package 10b. In addition, contact lens package 10b and contact lens package 10c each are adjacent two contact lens packages. Contact lens package 10d is adjacent only one contact lens package 10c.

The present packages 10 are configured to contain contact lenses. Examples of contact lenses suitable for the present packages are hydrogel contact lenses. The hydrogel contact lenses can be silicone hydrogel contact lenses or non-silicone hydrogel contact lenses. A silicone hydrogel contact lens is a hydrogel contact lens that comprises a silicone component. Examples of silicone hydrogel contact lenses that can be packaged in the present packages include silicone hydrogel contact lenses having the following U.S. Adopted Names (USANs): lotrafilcon A, lotrafilcon B, balafilcon A, galyfilcon A, senofilcon A, and comfilcon A. A non-silicone hydrogel contact lens is a hydrogel contact lens that is free of a silicone component. Examples of non-silicone hydrogel contact lenses that can be packaged in the present packages include hydrogel contact lenses having the following USANs: omafilcon A, ocufilcon A, ocufilcon B, ocufilcon C, ocufilcon D, ocufilcon E, methafilcon A, methafilcon B, among others. Some of the contact lenses, either silicone hydrogel contact lenses or non-silicone hydrogel contact lenses, provided in the present packages include one or more comfort agents. Examples of comfort agents include wettability enhancing agents that enhance the wettability of the contact lenses so that the contact lenses remain comfortable to a lens wearer, even at the end of the day, such as after about 14 hours of continuously wearing the contact lenses. One example of a comfort agent is a surfactant. Examples of surfactants include poloxamers and poloxamines, among others. Another example of a comfort agent is a phosphoryl choline derivative (PC), such as methacrylate phosphoryl choline (MPC), 2-methacryloyloxyethyl phosphoryl choline (HEMA-PC), and the like, and combinations thereof. One example of contact lenses that include a phosphoryl choline derivative is available from CooperVision under the tradename Proclear. One example of a contact lens that is present in the present packages comprises a polymer comprising units of hydroxyethyl methacrylate, and a phosphoryl choline derivative.

Each of the contact lens packages 10 of the array of packages 70 comprises a base member 12 and a sealing member 14. Individual contact lens packages 10 are described below. In the array 70, each sealing member 14 can be understood to be a component of a sealing layer 72. The illustrated sealing layer 72 spans the entire array of contact lens packages 70. Individual packages 10 can be separated from the array 70 along the weakening lines 74. The weakening lines 74 are provided in proximity to the juxtaposition of two contact lens packages 10. The weakening lines 74 can be understood to be perforations in the sealing layer 72. In other embodiments, the weakening lines 74 may be formed without perforations, such as by providing a thinner portion, for example a relatively thinner continuous strip, of the sealing layer 72 in the desired location.

In the illustrated embodiment of FIG. 1, the individual packages 10 of the array 70 are attached to each other. For example, the packages 10 can include an attachment portion between two of the packages. The attachment portion can be an integral component of the array of packages, or it can be an additional securing element connecting two or more of the packages 10.

In the illustrated embodiment of FIG. 1, the base members 12 of the plurality of packages 10 are coupled together and are further coupled together by the single sealing layer 72. In other embodiments, the packages 10 may be coupled together only at the base members 12 and not by the sealing layer 72, or the packages 10 may be coupled together only by the sealing layer 72 and not by the base members 12.

A sealed single contact lens package 10 is illustrated in FIG. 2. The contact lens package 10 comprises a base member 12 and a sealing member 14 coupled to the base member 12. FIG. 3 illustrates the contact lens package 10 of FIG. 2 with the sealing member 14 being partially removed. Thus, it can be understood that the sealing member 14 is a removable sealing member.

The sealing member 14 is coupled to a portion of the base member 12 to seal a contact lens in a cavity of the base member, as discussed herein. The sealing member 14, and also the sealing layer 72, can be formed from a variety of materials suitable for packaging of materials. Suitable materials should be able to be attached to a portion of the base member to maintain a contact lens contained in the cavity in a sterile condition. For example, the sealing member material should be able to be exposed to sterilizing conditions, such as autoclaving, gamma radiation, ultraviolet radiation, and the like without compromising the properties of the sealing member. The sealing member 14 may comprise one or more layers of materials, such as foils, plastics, and the like. The sealing member 14 may also include indicia, such as letters, numbers, graphics, and combinations thereof. In the illustrated embodiment of the present packages and arrays, the sealing member 14 is heat sealed to the base member 12. In other embodiments, adhesives or other suitable coupling mechanisms may be used to couple the sealing member 14 to the base member 12. Thus, the sealing member 14 provides a fluid impervious seal as well as a seal which prevents contamination of the sterilized contact lens and packaging liquid contained in the sealed cavity.

The base member 12, and also the contact lens package 10, comprise a proximal end region 18 and a distal end 20. The proximal end region 18 includes a grippable portion which can be held between two fingers of a person, such as a thumb and forefinger. For convenience, the proximal end region 18 can be understood to include a thumb grip. As shown in FIG. 3, the sealing member 14 can be removed by peeling the proximal portion of the sealing member 14 from the proximal end portion 18 of the base member 12. In the illustrated embodiment, the sealing member 14 is manually peeled by a person from the proximal end portion 18 towards the distal end 20 of the base member 12.

As shown in FIG. 3, the base member 12 comprises a first lateral side region 22 and an opposing second lateral side region 24. The first and second lateral side regions 22 and 24, respectively, extend from the proximal end region 18 towards the distal end 20 of the base member. The first and second lateral side regions, 22 and 24, respectively, can be parallel to each other, or can taper, such as by converging or diverging, towards the distal end 20.

An array 70 of contact lens packages 10 with the sealing layer 72 removed is illustrated in FIG. 4. For convenience, only one of the packages 10 of the array 70 of FIG. 4 is provided with reference numbers. It will be understood that the other packages 10 of the illustrated array 70 are identically structured. Each contact lens package 10 of the array 70 of FIG. 4 comprises a base member 12. The base member 12 comprises a cavity 16. The cavity 16 is located between proximal end region 18 and distal end 20. The base member 12 comprises a flange 26 extending outwardly from the cavity 16. The flange 26 comprises a flange top surface 28 and a flange bottom surface 30 (see FIG. 6).

In the illustrated embodiments presented herein, the flange 26 surrounds the perimeter of the cavity 26 and extends outwardly therefrom. The flange 26 includes a sealing area 40 to which the sealing member 14 can be attached to seal the cavity 16. The flange 26 can be understood to be a portion of the base member 12 extending outwardly from the cavity 16 to provide an attachment region for the sealing member 14. Near the proximal end of the cavity 16, the proximal portion of the flange 26 blends with the proximal end region 18 of the base member 12. The flange can have a width from about 1 mm to about 10 mm, for example, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. Therefore, the sealing area 40 to which the sealing member 14 is attached can be understood to be a region from about 1 mm to about 10 mm extending from the edge of the cavity 16. Beyond the sealing area 40, the sealing member 14 is not attached or coupled to the base member 12. The sealing member 14 can then be grasped by a person at this non-attached region or regions and removed from the base member 12.

An individual unsealed contact lens package 10 is illustrated in FIG. 5. FIG. 6 is a sectional view along line 6-6 of FIG. 5, and FIG. 7 is a sectional view along line 7-7 of FIG. 5.

The cavity 16 of the base member 12 of the contact lens package 10 is defined by a bottom wall surface 34 and a cavity sidewall surface 35. As shown in FIG. 6, the bottom wall surface 34 is a surface of a cavity bottom wall 32. The bottom wall 32 can be understood to comprise a first bottom wall surface 34 (e.g., defining the bottom surface of the cavity 16) and a second opposing bottom wall surface 36. The bottom wall 32 has a thickness defined as the distance between the first bottom wall surface 34 and the second opposing bottom wall surface 36. The bottom wall surface 34 is surrounded by a bottom wall surface perimeter 37.

The base member 12 also includes a cavity sidewall 38. The cavity sidewall 38 includes the cavity sidewall surface 35 that helps define the cavity 16. The base member 12 can be understood to comprise a cavity 16 defined by a proximal sidewall portion 38a, a distal sidewall portion 38b, a first lateral sidewall portion 38c, and a second opposing lateral sidewall portion 38d (see FIGS. 6 and 7). The cavity 16 is surrounded by a cavity perimeter 39. The cavity perimeter 39 can be understood to be located at the junction of the upper end of the cavity sidewall surface 35 and the flange 26.

The cavity 16 comprises a distal cavity portion 42 and a proximal cavity portion 44, as shown in FIGS. 5 and 6. The distal cavity portion 42 comprises a spherical component, and the proximal cavity portion 44 comprises an aspherical component. For example, the bottom wall surface 34 of the distal cavity portion 42 can be a portion of a spherical surface, and the bottom wall surface of the proximal cavity portion 44 can be an aspherical surface.

As shown in FIG. 8, the proximal end portion 18 of the base member 12 comprises a first surface 46 and an opposing second surface 48. The first surface 46 is contiguous with the flange top surface 28. A plurality of bumps 50 are illustrated extending from the first surface 46. A recess or depression 52 is shown extending from the first surface 46 toward the second surface 48 (see FIGS. 5 and 8). The proximal portion 18 also comprises a proximal stabilizing portion 54 that in conjunction with bottom surface 36 stabilizes the base member 12 on a flat surface, such as a horizontal surface. A support rib 56 is illustrated in FIG. 8 extending downwardly from the flange top surface 28 and surrounding portions of the lateral sides and the distal end of the base member.

The base members of the present packages can be formed from a variety of materials. In certain embodiments, including the illustrated embodiments, the base members are plastic members. The base members can be made by any conventional technique. In the illustrated embodiment, the base members are injection molded elements. In other embodiments, the base members may be thermoformed. Thus, the present base members can be understood to comprise, consist essentially of, or consist entirely of, a thermoplastic material. In one embodiment, the base member is made of a polyolefin resin material, such as polypropylene.

When the base members of the present packages are used in a lens inspection method the base member material can transmit light such that a contact lens located in the base member cavity can be illuminated and an image of the lens can be obtained for inspection.

An illustration of an ophthalmic lens inspection system 100 is shown in FIG. 9. The lens inspection system 100 comprises an illumination source 102, a lens 104, and a camera 106. A base member 12 of the present packages is located between the lens 104 and the camera 106. The base member 12 comprises a liquid 60 in the cavity and an ophthalmic lens 62 in the liquid. As described herein, the ophthalmic lens 62 can be a contact lens, such as a hydrogel contact lens.

As shown in FIG. 10, the illumination source 102 provides diffuse light 110 that is directed toward lens 104. In the illustrated embodiment, the illumination source 102 is a light emitting diode (LED). The diffuse light 110 is partially collimated by lens 104. Therefore, lens 104 can be understood to be a light collimating lens that is effective in converting diffuse light 110 to partially collimated light 112. The partially collimated light 112 is directed to the base member 12 of the contact lens package 10. The combination of the cavity bottom wall 34, the ophthalmic lens 62, and the liquid 60 cooperate to fully collimate the light as the light is directed towards the camera 106. Thus, the camera 106 receives parallel rays of light 114 and is able to obtain and produce a uniform bright field image of the ophthalmic lens. The image of the ophthalmic lens can be inspected for defects. If no defects are detected, the sealing member can be sealed to the base member. The sealed contact lens package can then be sterilized and distributed from the lens manufacturer.

In view of the present disclosure, an embodiment of the present contact lens blister packages comprises a thermoplastic base member. The thermoplastic base member comprises a light collimation cavity. The light collimation cavity can be understood to be a cavity that cooperates with liquid present in the cavity and a contact lens in the liquid to collimate partially collimated light to provide a uniform bright field image of the contact lens during an inspection procedure. The light collimation cavity is dimensioned, such as sized and shaped, to accommodate a hydrated contact lens in a liquid composition present in the cavity. The base member also comprises a flange extending outwardly from the light collimation cavity. The flange includes a sealing area to which a sealing member can be attached to seal the contact lens and liquid composition in the cavity.

The light collimation cavity of these embodiments may comprise a curved bottom surface having a bottom surface perimeter, as described herein. The cavity may also comprise an upwardly extending cavity sidewall surface extending from the bottom surface perimeter to an upper perimeter cavity edge. The upper perimeter cavity edge can be understood to define a light collimation cavity perimeter. The light collimation cavity perimeter is greater than the bottom surface perimeter. In other embodiments, the light collimation cavity perimeter is equal to the bottom surface perimeter.

In certain embodiments, the curved light collimation cavity bottom surface has a radius of curvature at least twice as large as the base curve of a hydrated contact lens that is to be placed in the cavity. For example, the radius of curvature can be at least 200% larger, at least 300% larger, or at least 400% larger than the base curve of the hydrated contact lens. For example, if a hydrated contact lens has a base curve of about 8 mm, the radius of curvature of the cavity bottom surface can be at least 16 mm, at least 24 mm, or at least 32 mm. In certain embodiments, the radius of curvature of the cavity bottom surface is from about 15 mm to about 26 mm. The radius of curvature can be identical along the length and along the width of the cavity, or they can be different. For example, in at least one embodiment, the cavity bottom surface has a radius of curvature from about 25 mm to about 26 mm along the length of the bottom surface, and an identical radius of curvature along the width of the bottom surface.

Some embodiments of the present contact lens blister packages comprise a cavity sidewall that extends from the planar flange region toward a central region of the light collimation cavity at an angle from about 80.degree. to about 90.degree.. In certain embodiments, the angle is less than 90.degree.. Orienting the sidewall or a portion thereof at these angles can be useful to provide sufficient space to accommodate a hydrated contact lens. It can be understood that the entire sidewall does not need to be oriented between about 80.degree. and about 90.degree.. For example, along the proximal portion of the cavity, as discussed herein, the sidewall can have a more shallow slope, which may be useful in facilitating removal of the contact lens from the cavity.

The base member of the present blister packages may also comprise a proximal end region having a thumb grip region, an opposing distal end region, a first side region extending from the proximal end region to the opposing distal end region, and an opposing second side region extending from the proximal end region to the opposing distal end region and substantially opposing the first side region. The light collimation cavity is located between the proximal end region and the distal end region and between the first and second side regions.

As shown in FIG. 6 and FIG. 7, the base member can have a length L extending from the proximal end region to the opposing distal end region. The base member can also have a width W extending from the first side region to the opposing second side region. The light collimation cavity has a cavity length that is parallel to the base member length, and has a cavity width that is parallel to the base member width. In certain embodiments, including the illustrated embodiments, the cavity length is greater than the cavity width. For example, the cavity width can be from about 60% to about 90% of the cavity length. In certain embodiments, the maximum cavity width is about 80% of the maximum cavity length.

As described herein, the sidewall surface of the cavity can vary in slope. For example, the illustrated embodiments of the present packages comprise a cavity having a cavity sidewall that has a proximal sidewall portion that has a shallower slope compared to a more distal portion of the cavity sidewall. The configuration of the cavity including the shape of the bottom surface and sidewall surface can be useful in maintaining the lens in a desired position within the cavity, such as during inspection, and can be useful in facilitating removal of the contact lens from the cavity onto a person’s finger. In view of the disclosure herein, some embodiments of the present light collimation cavities can be understood to have a cavity perimeter that is substantially egg-shaped with the narrowest portion of the perimeter being located closer to the proximal end region of the base member than to the opposing distal end of the base member. Other embodiments may include other shaped perimeters, including elliptical, ovoid, tear shaped, and even circular, if desired. In certain embodiments, the contact lenses remain substantially centered in the cavity when the package is placed on a horizontal surface with the cavity opening facing up.

Depending on the state of the present blister packages, certain embodiments comprise a liquid located in the light collimation cavity and a contact lens fully immersed in the liquid. For example, if the blister package is at a lens inspection station of a manufacturing line, at a sealing station of a manufacturing line, at a sterilization station of a manufacturing line, or at a distribution center or other storage location, including physician’s offices or lens wearer’s residences, the blister package comprises a liquid in the cavity and a contact lens in the liquid. The liquid can be understood to be a contact lens packaging solution. Examples of contact lens packaging solutions include saline solutions, such as buffered saline solutions. Some specific examples include borate buffered solutions, phosphate buffered solutions, bicarbonate buffered solutions, and the like. In certain embodiments, the liquid in the cavity includes a surfactant, such as non-ionic surfactants. Examples of surfactants that may included in the present packaging liquids include poloxamers, publicly available as Pluronics, and poloxamines, publicly available as Tetronics. Other surfactants include polysorbates, such as TWEENS, including TWEEN-80. The amount of surfactant can range from about 0.005 weight percent to about 2.0 weight percent. The liquid can additionally or alternatively include other agents, such as polyvinyl alcohol; polyvinyl pyrrolidone; cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, methyl cellulose, and methyl ether cellulose; and polyethylene glycol.

Another embodiment of a contact lens blister package comprises a thermoplastic base member that comprises a light collimation cavity defined by a bottom wall surface. The bottom wall surface has a perimeter, and the cavity is further defined by a sidewall surface extending from the bottom wall surface perimeter upwardly toward a flange extending outwardly from the cavity. In this embodiment, the cavity has a maximum length of about 25 mm and a maximum width of about 20 mm, and the bottom wall surface has a radius of curvature from about 15 mm to about 26 mm.

The bottom wall surface of this embodiment may be a surface of a cavity bottom wall, as described herein. In certain embodiments, the cavity bottom wall has a thickness less than 1 mm. In further embodiments, the thickness of the bottom wall is about 0.8 mm. The thickness of the bottom wall is substantially constant across the entire bottom wall in certain embodiments. For example, the thickness of the bottom wall may vary from 0.75 mm to 0.85 mm.

The cavities of the present packages are dimensioned to accommodate a hydrated contact lens. Thus, a cavity can have a maximum depth so that a hydrated contact lens can be fully immersed in a liquid composition present in the cavity. In certain embodiments, the cavity has a maximum depth less than 9 mm. For example, the cavity can have a maximum depth of about 6 mm, about 7 mm, about 8 mm, or about 9 mm. In at least one embodiment, the cavity has a maximum depth of about 7.0 mm.

Certain embodiments of the blister package comprise a cavity having a sidewall surface that comprises a proximal sidewall portion, a distal sidewall portion, a first lateral sidewall portion, and a second lateral sidewall portion opposing the first lateral sidewall portion. One or more of the distal sidewall portion, the first lateral sidewall portion, and the second lateral sidewall portion is oriented at an angle of about 5 degrees from a straight line extending from the bottom wall surface and perpendicular to a top surface of the flange.

The base member of the present packages may also comprise a proximal end region that is grippable by fingers of a person, such as a thumb grip region as described herein. In certain embodiments, the proximal end region comprises a first surface that is continuous with a top surface of the flange, and a plurality of raised bumps extending from the first surface. In certain embodiments, such as the illustrated embodiments, the proximal end region may comprise a gate recess projecting from the first surface. In additional embodiments, the proximal end region may comprise indicia, such as numbers, letters, graphics, and combinations thereof. For example, a thumb grip region may include the tradename of the contact lens located in the cavity. The indicia can be provided as ink on the thumb grip region, or can be raised structures similar to the raised bumps and produced during the manufacture of the base member.

In certain embodiments, the flange of the base member has a maximum width of about 3 mm. The base member may also have a maximum width of about 27 mm, a maximum length of about 46 mm.

Another embodiment presented herein is a thermoplastic base member of a contact lens blister package. The base member has a length and a width, as described herein. The base member comprises a cavity having a bottom wall surface and a sidewall surface extending perimetrically from the bottom wall surface. The base member also comprises a flange outwardly extending from the cavity. The bottom wall surface of the cavity has a radius of curvature from about 15 mm to about 26 mm along the length of the base member and along the width of the base member. In other words, the radius of curvature of the bottom wall surface is equal in both directions (e.g., along the length and along the width of the base member). In certain embodiments, the bottom wall surface is a surface of a bottom wall having a thickness of about 0.8 mm. In additional embodiments, the radius of curvature is from about 25 mm to about 26 mm. In further embodiments, the cavity has a maximum depth of about 7 mm. The base member may comprise a proximal finger grippable region, and the cavity has a proximal end with a width that is less than the distal end width of the cavity. For example, the cavity can have the configuration as shown in FIG. 5. In addition, the base member can further comprise a support rib depending from the flange and spaced apart from the cavity, as described herein.

In addition, the contact lenses that may be present in the cavity liquid include silicone hydrogel contact lenses and non-silicone hydrogel contact lenses, as described herein. In certain embodiments, the present packages comprise a daily disposable contact lens, such as a contact lens that is intended to be worn for about 10-16 hours and then discarded.

The present packages may also comprise a sealing member that is removably attached to the sealing area of the flange. The attached sealing member forms a sealed enclosure containing the liquid and contact lens. In certain embodiments, the sealing member is attached to the base member after a lens inspection procedure. Thus, such embodiments may be understood to be post-inspected contact lens blister packages.

As described herein, the base members of the present packages can be made from a variety of thermoplastic materials. In certain embodiments, the base member is an injection molded polyolefin material. For example, some of the base members, including the illustrated base members, are formed from polypropylene.

As shown in the drawings, the present blister packages can be coupled together to form an array of contact lens blister packages. The present arrays can consist of two, three, four, five, six, or more blister packages arranged in a strip, as described herein.

One specific example of a contact lens blister package comprises an injection molded polypropylene base member comprising a cavity and an outwardly extending flange. The cavity has an oblong configuration when viewed from the top, as shown in FIG. 5. The cavity has a maximum length of about 25 mm to about 26 mm, a maximum width of about 20 mm, and a maximum depth of about 7 mm. The bottom surface of the cavity has a single radius of curvature between about 25 mm and about 26 mm in both the X and Y directions (e.g. along the length and width of the cavity). The wall thickness of the base member is about 0.80 mm. The total length of the base member is about 46 mm, and the total width is about 26 to about 27 mm. The sealing area width around the cavity is about 3.0 mm. The proximal end region of the base member comprises a thumb grip with a plurality of raised bumps and a gate recess formed from an injection molding procedure. The proximal portion of the cavity has a sloped sidewall oriented at an angle of about 30.degree. relative to the top surface of the flange.

The present packages and arrays of packages can be made using conventional methods known to persons of ordinary skill in the art. For example, the base members of the packages and packages arrays can be injection molded from thermoplastic resin materials in an injection molding machine. A liquid, such as a contact lens packaging solution, can be dispensed in the cavity of the base member, and a contact lens can be inserted into the liquid. Alternatively, a contact lens can be placed into the cavity, and a liquid can then be dispensed in the cavity. The sealing member can then be applied to the sealing area of the base member to seal the liquid and contact lens in the cavity. The sealed package containing the hydrated contact lens can then be sterilized and prepared for distribution.

Typically, before the sealing member is applied to the base member, the lens located in the cavity can be inspected. The inspection can be manual or automated. Automated inspection methods are beneficial in the production of large amounts of contact lenses. Thus, a method of inspecting a hydrated contact lens comprises providing a contact lens in a liquid present in a cavity of the packages described herein. Partially collimated light is directed through the cavity, the liquid, and the contact lens to produce fully collimated light. A bright field image of the contact lens is obtained using a camera that receives the fully collimated light. The image can then be transferred to a computer for processing, such as by running one or more lens inspection algorithms using the image. The methods can be practiced serially or in parallel. For example, in certain embodiments, such as when arrays of blister packages are used in the production of contact lenses, the method is performed simultaneously on a plurality of packages. By producing uniform illumination of the contact lens based on the unique bottom surface configuration of the cavity, the lens edge and lens defects can be high-lighted by the collimated light.

Various additional features of the blister packages and base members can be provided. For example, embodiments of the present packages and base members may comprise a cavity having a non-planar proximal sidewall portion. A single package or base member may be understood to comprise only one cavity, for example, a single package may comprise a base member that consists of a cavity, a flange, and a thumbgrip region. The package may be free of markings that indicate the diameter of the contact lens contained therein. The package or base member may be free of lateral opposing indentations for grasping between a thumb and index finger. The cavity of the package or base member can be free of raised ribs extending into the cavity from a cavity bottom surface. In addition, the radius of curvature of the bottom surface of the cavity can be much greater than 12 mm, as described herein. The cavity can be understood to be free of an inwardly extending contact lens retaining lip extending from the flange region towards the center of the cavity. In addition, the cavity can be understood to be a single chamber for storing the contact lens. The cavity bottom wall can be understood to be non-invertible. In certain embodiments, the present packages and base members comprise a non-semi-circular cavity, a non-rectangular flange, or both. Embodiments of the present packages are free of grooves to receive peripheral portions of the flexible cover sheet. Some embodiments of the present packages and base members can be understood to be free of a plurality of interlockable or interengageable legs. The cavities of the packages and base members can be understood to be free of a convex mold portion extending upwardly from the bottom surface of the cavity. As discussed herein, embodiments of the present packages and base members can have a cavity with a bottom wall thickness greater than 0.75 mm. In addition, embodiments can have cavities that contain more than 0.75 ml of a packaging solution.

Although the disclosure herein refers to certain specific embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation. Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. In addition, any feature or combination of features may be specifically excluded from any embodiment disclosed herein. The intent of the foregoing detailed description, although discussing exemplary embodiments, is to be construed to cover all modifications, alternatives, and equivalents of the embodiments described in the present description and claims.

1. A liquid diagnostic contact lens, comprising: a main body having a concave lens; a heavy fluid disposed on a top surface of the concave lens; a transparent plate airtightly attached to an upper surface of the main body, and forming an airtight encapsulating room between the top surface of the concave lens and the upper surface of the main body; and a supporting element disposed at a bottom of the main body; wherein the heavy fluid is received in the encapsulating room.

2. The liquid diagnostic contact lens according to claim 1, wherein the concave lens is integrally formed with the main body.

3. The liquid diagnostic contact lens according to claim 1, wherein the encapsulating room further comprises at least another fluid having a specific gravity different from the heavy fluid received therein and mixed with the heavy fluid.

4. The liquid diagnostic contact lens according to claim 3, wherein the another fluid is oil.

5. The liquid diagnostic contact lens according to claim 1, wherein the supporting element comprises an annular wall and a cone shaped supporting base extended from a bottom of the annular wall, and a lower portion of the main body is tightly fitted into an inside of the annular wall.

6. The liquid diagnostic contact lens according to claim 1, wherein the supporting element is cone shaped, integrally formed with the main body and directly extended from a lower portion of the main body.
Contact Lens Description
BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a magnification device for ophthalmic examination and surgery.

2. The Prior Arts

When conducting a diagnostic examination or a therapeutic procedure to an eye, an ophthalmologist often needs to use opthalmoscope, diagnostic contact lens, slit lamp, or ultrasound device, etc. to diagnose the eye condition and then treat thereby.

A conventional diagnostic contact lens is a flat lens, a concave lens, or a prism. A flat lens is often used for examining a posterior pole of the eye. However, in viewing a peripheral retina, various prisms of different diopters are often required. The ophthalmologist directly places the prism onto the eye. The prism is turned or replaced with another one having a different diopter according to the position to be examined. It is inconvenient to use and may even accidentally cause eye injuries.

SUMMARY OF THE INVENTION

A primary objective of the present invention is to provide a liquid diagnostic contact lens for ophthalmic diagnostic examination or a therapeutic procedure. The liquid diagnostic contact lens can be directly placed on a surface of an eye. Moreover, the liquid diagnostic contact lens can be adjusted to view a wide range of the eye, such as from the posterior pole to the peripheral retina, without turning or replacing with another liquid diagnostic contact lens. The operation of the liquid diagnostic contact lens not only saves a lot of time, but also drastically eliminates the risk of accidental injury to the eye.

The liquid diagnostic contact lens is a magnifying lens specifically adapted for ophthalmic inspections or operations. According to an embodiment of the present invention, the liquid diagnostic contact lens includes a main body having a concave lens configured thereto, and a supporting element configured at a lower portion of the main body. The concave lens has a top surface, on which a heavy fluid is adaptively placed. A transparent plate is employed over the top surface of the concave lens so as to define an encapsulating room and encapsulate the heavy fluid therein. In operation, an ophthalmologist may place the supporting element onto the eye, and views various interior spots of the eye by adaptively adjusting the eye. The liquid diagnostic contact lens is tilted along with the eye. The top surface of the heavy fluid is kept in a horizontal level due to gravity so the heavy fluid is formed as a flat lens or a prism having adjustable diopters.

According to the present invention, the main body itself can be a concave lens, or otherwise includes a concave lens equipped thereto.

According to another embodiment of the present invention, in addition to the heavy fluid, the encapsulating room may further have at least another fluid with specific gravity different from the heavy fluid, such as oil, received therein, so as to modify the optical refraction characteristics of the liquid diagnostic contact lens.

According to still another embodiment of the present invention, the supporting element can be either integrally formed with the main body, or individually formed and later equipped at a lower portion of the main body. In the case that the supporting element is individually formed, the supporting element has an annular wall, whose bottom includes a cone shaped supporting base extended therefrom. The lower portion of the main body is fitted into the annular wall of the supporting element.

The liquid diagnostic contact lens according to the present invention is kept on a fixed position of the eye without turning or replacing diagnostic contact lens, and can examine the eye simply by adjusting the position and angle of the eye. In such a way, the operation is simple, convenient, and will not injure the eye.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be apparent to those skilled in the art by reading the following detailed description of preferred embodiments thereof, with reference to the attached drawings, in which:

FIG. 1 is an exploded view showing a liquid diagnostic contact lens according to an embodiment of the present invention;

FIG. 2 is an exploded cross-sectional view illustrating the liquid diagnostic contact lens shown in FIG. 1;

FIG. 3 is a cross-sectional view showing the liquid diagnostic contact lens of FIG. 2 after being assembled;

FIG. 4 is a cross-sectional view illustrating a liquid diagnostic contact lens according to another embodiment of the present invention; and

FIG. 5 is a schematic view illustrating a practical operation of the liquid diagnostic contact lens according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

FIGS. 1 to 3 illustrate a liquid diagnostic contact lens adapted for ophthalmic inspections or operations according to a first embodiment of the present invention. The liquid diagnostic contact lens includes a main body 1, a transparent plate 2, a supporting element 3, and a suitable heavy fluid 4. The main body 1 includes a concave lens 11 configured integrally at a center thereof, and a lower portion 12 configured integrally at a bottom thereof. The lower portion 12 is adapted for engaging with the supporting element 3. The concave lens 11 has a top surface and a bottom surface. The top surface of the concave lens 11 is a concave surface having a certain curvature which is not restricted by the present invention. A space is defined between the top surface of the concave lens 11 and an upper surface of the main body 1. The heavy fluid 4 is received in the space, and encapsulated by the transparent plated 2 disposed on the upper surface of the main body 1. The transparent plate 2 can be fixed onto the upper surface of the main body 1 by high frequency sealing, or be adhered to the upper surface of the main body 1 with adhesive. Therefore, the space between the top surface of the concave lens 11 and the transparent plate 2 is formed as an airtight encapsulating room which encapsulates the heavy fluid 4 therein. Instead of the integrally-formed concave lens 11 and main body 1, the concave lens 11 and the cylindrical main body 1 may be two separated pieces (not shown in Figures). The concave lens 11 is tightly fitted into the inside of the main body 1.

The heavy fluid 4 is a fluid having a specific gravity greater than that of water. The heavy fluid 4 is a medium for cooperating with the concave lens 11 to determine the optical refraction characteristics. As such, according to another embodiment of the present invention, at least another fluid having a specific gravity different from the heavy fluid 4 is further introduced into the encapsulating room. In such a way, the encapsulating room has a mixture of the heavy fluid 4 and at least another fluid received therein. For example, the another fluid can be oil, which has a smaller specific gravity than the heavy fluid 4. When received in the encapsulating room, the heavy fluid 4 stays under the another fluid, because of its greater specific gravity. For example, when the encapsulating room has a mixture of the heavy fluid 4 and three another fluids received therein, there are four layers of fluids received in the encapsulating room.

The supporting element 3 is made of a hypoallergenic material, such as silicone or the like. The supporting element 3 includes an annular wall 31, and a cone shaped supporting base 32 extended from a bottom of the annular wall 31. The lower portion 12 of the main body 1 is fitted into an inside of the annular wall 31 of the supporting element 3. The supporting base 32 configures a part of a cone whose diameter enlarges as the supporting base 32 extends, thereby preventing the supporting base 32 from blocking the view in operation.

The bottom surface of the concave lens 11 is also a concave surface. The curvature of the bottom surface of the concave lens 11 is designed to adapt to a general shape of a human eye.

Referring to FIG. 4, the supporting base 32 according to still another embodiment of the present invention is made of silicone or other materials which won’t cause allergic reaction to human body, and is integrally formed with the main body 1.

FIG. 5 is a schematic view illustrating the liquid diagnostic contact lens according to the present invention on an examined eye. In practical operation, an ophthalmologist places the liquid diagnostic contact lens directly onto the eye, and adaptively adjusts a position or an angle of the eye. Associating with the adjustment of the eye, the main body 1 is correspondingly tilted. Even though the main body 1 is tilted in accordance with the adjustment made to the eye, a top surface of the heavy fluid 4 is maintained horizontal due to the gravity. As such, corresponding to different position of the concave lens 11, the heavy fluid 4 is featured with different thickness, so as to configure a liquid prism. In facilitation with such a liquid prism and the concave lens 11, the ophthalmologist can get a better view to the interior of the eye. The operation of the liquid diagnostic contact lens on the eye can be achieved simply by adjusting the position and the angle of the eye and does not need to turn or replace the diagnostic contact lens. In such a way, the operation is simple, convenient, and won’t injure the eye.

Although the present invention has been described with reference to the preferred embodiments thereof, it is apparent to those skilled in the art that a variety of modifications and changes may be made without departing from the scope of the present invention which is intended to be defined by the appended claims.

1. An apparatus for manipulation and cleaning of a contact lens, said apparatus comprising an at least one eyepiece, an at least one body, and a cleaning housing, said at least one eyepiece when attached to said at least one body defining an opening into said at least one body and said at least one eyepiece comprising: (i) a head for engaging a contact lens; and (ii) an eyelid opening means, said at least one body containing a contact lens manipulation means comprising an elongate arm defining a longitudinal axis and an arm movement means communicating with said arm, said arm movement means effecting movement of said arm between a retracted position and an extended position; said apparatus arranged such that when said at least one eyepiece is attached to said at least one body and the face of a user is in contact with said at least one eyepiece, an eyeball and upper and lower eyelids of said user being positioned over said opening, said eyelid opening means is engageable with said upper and lower eyelids to retain them open, said arm being engaged with said head and being extendable to contact said eyeball of said user and effect insertion and removal of a contact lens into and from said eye; said cleaning housing comprising contact lens cleaning means and being engageable with said at least one eyepiece, such that when said at least one eyepiece and said cleaning housing are engaged, said contact lens cleaning means can effect cleaning of a contact lens engaged with said head of said at least one eyepiece.

2. An apparatus according to claim 1, said apparatus comprising two eyepieces, a body and a cleaning housing, said eyepieces being removeably attachable to said body and said cleaning housing being engageable with said eyepieces, such that when at least one eyepiece is engaged with said cleaning housing, said contact lens cleaning means can effect cleaning of any contact lens engaged with said head of said eyepiece.

3. An apparatus according to claim 2, wherein only one of said eyepieces is attachable to said body at a time.

4. An apparatus according to claim 1 wherein said arm is capable of releasably engaging said head.

5. An apparatus according to claim 1 wherein said arm extends through said opening to engage said head.

6. An apparatus according to claim 1 wherein said arm movement means effects movement of said arm between a retracted position in which said arm is contained within said body of said apparatus, and an extended position in which said arm extends through said opening.

7. An apparatus according to claim 1 wherein said arm is attached to said head.

8. An apparatus according to claim 1, wherein said eyelid opening means comprises a plurality of arms, each of said arms being movable within a guide track positioned within said eyepiece, wherein said arms, responsive to contact against said upper and lower eyelids, move along said guide tracks engaging and retaining said upper and lower eyelids in an open position.

9. An apparatus according to claim 1 wherein said contact lens manipulation means comprises a rack associated with said arm, said rack engaging with a worm associated with said arm movement means.

10. An apparatus according to claim 1 wherein said contact lens manipulation means comprises an electric motor to effect movement of said arm between said extended and retracted positions.

11. An apparatus according to claim 1 wherein said head is resiliently deformable between a first extended state and a second contracted state, wherein said head is capable of gripping a contact lens when said head is in said contracted state.

12. An apparatus according to claim 1, said contact lens manipulation means additionally comprising a head manipulating means to effect gripping of said contact lens by said head.

13. An apparatus according to claim 12 wherein said head manipulating means comprises a longitudinally elongate sleeve positioned coaxial with and radially extended from said arm and defining first and second ends, said arm being positioned radially inwards of said sleeve and defining a head-contacting end, said first end of said sleeve terminating adjacent to said head-contacting end of said arm, wherein said head and arm are movable relative to said sleeve along said longitudinal axis between a first position in which said head does not engage said sleeve and is in said first extended state, and a second position in which said head engages said sleeve and is deformed into said second contracted state, thereby effecting gripping of said contact lens.

14. An apparatus according to claim 13, wherein said head manipulating means further comprises a coupling control means, said coupling control means being capable of coupling and uncoupling said sleeve and said arm between coupled and uncoupled states, wherein in said coupled state said arm moves in conjunction with said sleeve, and in said uncoupled state said arm moves independently of said sleeve.

15. A method of inserting or removing at least one contact lens into or from an eye of a user using an apparatus for manipulation of a contact lens, said apparatus comprising an at least one eyepiece, a cleaning housing and an at least one body, said at least one eyepiece when attached to said at least one body defining an opening into said at least one body and said at least one eyepiece comprising: (i) a head for engaging a contact lens; and (ii) an eyelid opening means, said at least one body containing a contact lens manipulation means comprising an elongate arm defining a longitudinal axis and an arm movement means communicating with said arm, said arm movement means effecting movement of said arm between a retracted position and an extended position; said apparatus arranged such that when said at least one eyepiece is attached to said at least one body and the face of a user is in contact with said at least one eyepiece, an eyeball and upper and lower eyelids of said user being positioned over said opening, said eyelid opening means is engageable with said upper and lower eyelids to retain them open, said arm being engaged with said head and being extendable to contact said eyeball of said user and effect insertion and removal of a contact lens into and from said eye; said method comprising the steps of: (i) contacting the face of a user with said at least one eyepiece, an eyeball and upper and lower eyelids of the user being positioned over said opening; (ii) operating said apparatus so as to engage said upper and lower eyelids and retain them open and extend said arm engaged with said head to contact said eyeball of said user and effect insertion or removal of a contact lens into or from said eye; (iii) engaging said cleaning housing with said at least one eyepiece having a contact lens engaged with said head; and (iv) operating said apparatus so as to effect cleaning of a contact lens engaged with said head of said eyepiece; said cleaning housing comprising contact lens cleaning means and being engageable with said eyepiece, such that when said at least one eyepiece and cleaning housing are engaged, said contact lens cleaning means can effect cleaning of a contact lens engaged with said head of said eyepiece.
Contact Lens Description
TECHNICAL FIELD

This invention relates to an apparatus for hygienic insertion, positioning and removal of contact lenses from a person’s eyes.

BACKGROUND INFORMATION

It is estimated that more than 150 million people in the USA use corrective eye wear for refractive errors (Prevent Blindness America, 2002). Contact lenses represent an increasingly popular and convenient solution to correct defective vision such that the contact lens market has a growth of approximately 20% year over year, and sales have grown from $16 million in 1998 to an expected $184 million in 2003. Contact lenses by their very nature are small, delicate and easily damaged, and this leads to problems associated with handling and insertion for a great many users. Installation and removal of contact lenses can be physically cumbersome and time consuming, and the majority of users are known to experience difficulties when they first start wearing contact lenses.

Many people go on to find the insertion and removal of contact lenses a natural thing to do, but a significant proportion of people are believed to have continuing difficulties/problems associated with contact lens insertion/removal. It is widely perceived within the industry that there is a requirement for a solution to overcome the problems associated with manipulation, insertion and removal of contact lenses.

Hygiene can also pose a problem with regard to the wearing of contact lenses-in the event that a contact lens is dropped during insertion into or removal from the eye it may become contaminated with particulate matter (e.g. dirt) or micro-organisms (e.g. bacteria), which can cause infections, discomfort, and damage to the eye. There is also a risk that a contact lens may become contaminated through contact with the skin of a finger or the palm of the hand. A variety of microorganisms are involved in causing eye infections, but the most commonly isolated organisms are Serratia, Pseudomonas and Acinetobacter (from contaminated sterilizing and washing solutions) and staphylococci (from direct handling of contact lenses). In order to maintain good ocular hygiene it is important that a contact lens user washes their hands prior to insertion/removal of a contact lens, and that the contact lenses are cleaned properly in accordance with the manufacturers instructions.

Indeed, deviation from recommended wear and care procedures are the prime factors involved in contraction of Acanthamoeba keratitis, a serious and painful condition which may cause long-term damage to the eye. Cleaning and disinfection of contact lenses can thus be time consuming and impractical, particularly when a user does not have a ready means available to clean their hands prior to handling their contact lenses e.g. whilst travelling. Survey evidence suggests that 75% of existing contact lens users reported that they would use an apparatus which would not only insert/remove their lenses but also clean and store them.

Prior art contact lens insertion and removal devices include U.S. Pat. No. 4,201,408, U.S. Pat. No. 4,427,226, and WO 99/21519. U.S. Pat. No. 4,201,408 discloses a device having a cup to receive a contact lens, the cup having a hole connected to a tube. The tube serves to apply negative pressure to the contact lens in order to pick it up, and positive pressure to facilitate discharge of the contact lens onto the eyeball. The tube also provides a light source, visualized as a bright spot of light which can serve as a target by a user, thereby making the process of contact lens insertion/removal easier. A means is provided to distort the cup and the contact lens which aids removal of a contact lens from the eye.

U.S. Pat. No. 4,427,226 discloses a device combining a means to position or remove a contact lens combined with a means to keep the upper and lower eyelids open. Using one hand, the eyelids are retained open using eyelid engaging means, and the contact lens is positioned or removed using the other hand and a pair of flexible tweezers.

WO 99/21519 discloses a package containing a contact lens stored in saline solution. The package comprises an applicator for applying the contact lens to the eye, thereby circumventing the requirement for a user to physically pick up the contact lens and place it on their palm prior to insertion onto the eyeball. By removing contact between fingers and the contact lens, the chances of contaminating the contact lens by a user are thereby considerably reduced, and good ocular hygiene is maintained.

Prior art devices are primarily used for the insertion and/or removal of contact lenses from the eye. The devices, although minimizing contact with skin and therefore the risks of contamination of a contact lens, still require the use of both hands, typically with one hand holding open the eyelids, and the other hand inserting the contact lens through the use of an applicator or tweezers. The application step, although facilitated through the use of tweezers or an applicator, can still be problematic since it invariably requires a degree of skill and dexterity by the user-a good aim and appropriate use of force is required to position a contact lens on the eyeball. Importantly, none of the prior art devices are designed for cleaning contact lenses–the contact lenses may be removed and stored using the prior art devices, but cleaning of a contact lens prior to storage invariably involves manual (i.e. fingertip) “scouring” or “scrubbing” of the contact lens with a cleaning solution typically comprising a detergent followed by rinsing with a sterile saline solution.

SUMMARY

It is an object of the present invention to overcome the prior art disadvantages by providing an apparatus for use with a contact lens which comprises automatic contact lens installation, insertion, removal, manipulation, cleaning, and storage steps, without the need for a user to physically manipulate or clean the contact lens themselves.

According to a first aspect of the present invention there is provided an apparatus for manipulation and cleaning of a contact lens, said apparatus comprising an at least one eyepiece, an at least one body, and a cleaning housing, said at least one eyepiece when attached to said at least one body defining an opening into said at least one body and said at least one eyepiece comprising: (i) a head for engaging a contact lens; and (ii) an eyelid opening means,

said at least one body containing a contact lens manipulation means comprising an elongate arm defining a longitudinal axis and an arm movement means communicating with said arm, said arm movement means effecting movement of said arm between a retracted position and an extended position;

said apparatus arranged such that when said at least one eyepiece is attached to said at least one body and the face of a user is in contact with said at least one eyepiece, an eyeball and upper and lower eyelids of said user being positioned over said opening, said eyelid opening means is engageable with said upper and lower eyelids to retain them open, said arm being engaged with said head and being extendable to contact said eyeball of said user and effect insertion and removal of a contact lens into and from said eye;

said cleaning housing comprising contact lens cleaning means and being engageable with said at least one eyepiece, such that when said at least one eyepiece and said cleaning housing are engaged, said contact lens cleaning means can effect cleaning of a contact lens engaged with said head of said at least one eyepiece.

The at least one eyepiece may be removeably attachable to the at least one body.

Alternatively the at least one eyepiece may be permanently engaged with the at least one body.

Thus, the apparatus may comprise one eyepiece attached to one body, and a cleaning housing which is engageable with the eyepiece.

The at least one eyepiece may define an opening into the body and an eyehole. A user may position their eye over the eyehole and look into the eyehole.

The at least one eyepiece may be adapted such that when the face of a user is in contact with the eyepiece, external light is not visible to the user, e.g. is prevented from entering between the face of the user and the eyepiece, thus being prevented from entering the volume defined by the person’s face, the eyepiece and the body. The at least one eyepiece may extend around the eyelid opening means, thereby protecting it from damage. The at least one eyepiece may be sprung such that when it is pressed against the face of a user, it retracts towards the body of the apparatus and the eyelids of the user contact the eyelid opening means. The arms may be spaced so as to not contact the eyeball of a user.

The eyepiece or body may comprise a light source such that when a user looks through the eyepiece into the opening of the device, the user sees a small focussed spot of light, thereby preventing the user from seeing the arm and the head of the device. The inability of the user to see the components of the device, both in a static or moving state, minimizes flinching by the user and facilitates insertion and removal of contact lenses. The spot of light may be colored to indicate either normal function or to prompt the user to change the batteries of the device, or their contact lenses. The light may also be used to signal other information to a user.

The apparatus (for example the body) may comprise a control (e.g. a button or switch), for use by a user to control the contact lens manipulation means. By actuating the control, a user can thus install or remove a contact lens into their eye, or remove a contact lens from its packaging and install it into the apparatus. All the functions of the apparatus may be controlled through the use of the control.

The apparatus may comprise two eyepieces, two bodies, and a cleaning housing, each eyepiece being attached to a body, the cleaning housing being engageable with the eyepieces. Each eyepiece may define an opening into the body, and may comprise a head for engaging a contact lens and an eyelid opening means. The body may comprise a contact lens manipulation means, wherein when the face of a user is in contact with the eyepiece, an eyeball and upper and lower eyelids of the user being positioned over the opening, the eyelid opening means is engageable with the upper and lower eyelids to retain them open, the contact lens manipulation means comprising an elongate arm defining a longitudinal axis and an arm movement means communicating with the arm, the arm movement means effecting movement of the arm between a retracted position and an extended position;

wherein when the at least one eyepiece is attached to the at least one body and the face of a user is in contact with the at least one eyepiece, an eyeball and upper and lower eyelids of the user being positioned over the opening, the eyelid opening means can engage the upper and lower eyelids and retain them open, the arm engaged with the head extending to contact the eyeball of the user and effect insertion and removal of a contact lens into and from the eye;

the cleaning housing comprising contact lens cleaning means and being engageable with the at least one eyepiece, such that when the at least one eyepiece and the cleaning housing are engaged, the contact lens cleaning means can effect cleaning of a contact lens engaged with the head of the at least one eyepiece.

The apparatus may comprise two eyepieces, one body and a cleaning housing, the eyepieces being removeably attachable to the body and the cleaning housing being engageable with the eyepieces, such that when at least one eyepiece is engaged with the cleaning housing, the contact lens cleaning means can effect cleaning of any contact lens engaged with the head of the eyepiece.

The apparatus may be formed such that only one of the two eyepieces is attachable to the body at any given time.

The arm may be capable of releasably engaging the head.

The arm may extend through the opening to engage the head.

The arm movement means may effect movement of the arm between a retracted position in which the arm is contained within the body of the apparatus, and an extended position in which the arm extends through the opening.

The arm may be attached to the head. The eyepieces may each hold a contact lens, the prescription of which corresponds to a particular eye. The eyepieces may be formed so that one eyepiece has a shape adapted for use with the left eye of a user, and the other eyepiece has a shape adapted for use with the right eye. The shape of an eyepiece may be such that if it is attempted for use with the incorrect eye, an incorrect fit is made which is noticeable to the user. This prevents insertion into the eye of a contact lens of the wrong shape or prescription.

The eyelid opening means may comprise a plurality of arms, each of the arms being movable within a guide track positioned within the eyepiece, wherein the arms, responsive to contact against the upper and lower eyelids of a user, move along the guide tracks engaging and retaining the upper and lower eyelids in an open position.

The contact lens manipulation means may comprise a rack associated with the arm, the rack engaging with a worm associated with the arm movement means. Movement of the rack is responsive to rotational movement of the worm about it’s longitudinal axis. The use of rack and worm gears will be well known to a person skilled in the art. The contact lens manipulation means may comprise an electric motor to effect movement of the arm between extended and retracted states. Movement of the arm is not limited to the use of a rack and worm-indeed, other ways of moving the arm are envisaged and will be well known to a person skilled in the art. In particular, the arm movement means may comprise apparatus described in EP 0784252 (also known in the art as “SMAC” devices/technology), effecting actuation of the arm and in particular to effecting a “soft landing” of the head (and thus of a contact lens when engaged with the head) on the eye of a user. Actuators, spring arrangements and other devices described in EP 0635786 and EP 0778656 may also be used.

The apparatus, particularly the eyepiece, may be provided with a fluid drainage arrangement in order to allow fluid such as contact lens cleaning fluid to be drained from the eyepiece, preventing its damaging the apparatus contained in the body. For example, the at least one eyepiece may be provided with fluid drainage means. In addition, seal means may be provided (for example incorporated into the at least one eyepiece and/or into the at least one body) preventing the transmission of fluid from the at least one eyepiece into the at least one body. This can allow movement of the arm without allowing the transmission of fluid.

The head may be resiliently deformable, defining a first extended position, and a second contracted position, wherein the head is capable of gripping a contact lens when the head is in the second position. The head of the eyepiece may be shaped to complement the shape of a contact lens (e.g. cup shaped), and/or it may comprise a plurality of gripping arms e.g. two, three or four arms. The head may be manufactured from a resiliently deformable material, e.g. a low shore factor thermoplastic elastomer (TPE). The head and gripping arms may be moulded to facilitate gripping or pinching of a contact lens when the head is in the second (contracted) position.

The contact lens manipulation means may comprise a head manipulating means to effect gripping of a contact lens by the head of the eyepiece, to facilitate removal of a contact lens from the eye or its packaging.

The head manipulating means may comprise a longitudinally elongate sleeve positioned coaxial with and radially extended from the arm and defining first and second ends, the arm being positioned radially inwards of the sleeve and defining a head-contacting end, the first end of the sleeve terminating adjacent to the head-contacting end of the arm, wherein the head and arm are movable relative to the sleeve along the longitudinal axis between a first position in which the head does not engage the sleeve and is in the first extended state, and a second position in which the head engages the sleeve and is deformed into the second contracted state, thereby effecting gripping of the contact lens.

The sleeve and the arm may be reversibly coupled to one another. The head manipulating means may comprise a coupling control means, the coupling control means being capable of coupling and uncoupling the sleeve and the arm between coupled and uncoupled states.

In the coupled state the arm moves in conjunction with the sleeve, and in the uncoupled state the arm moves independently of the sleeve.

The coupling control means may be electronic or electromagnetic (for example a solenoid).

The coupling control means may be preferably operatively linked to the arm movement means, and controlled such that the sleeve and arm are automatically uncoupled when the head of the arm contacts a contact lens placed in position on the eyeball, prior to retraction of the arm and gripping of the contact lens. Retraction of the arm through the sleeve need only be a short distance, for example between 0.3-2.0 cm. Retraction of the arm may be controlled in order to avoid the head and contact lens being pulled through the first end of the sleeve and damaged.

The contact lens cleaning means may comprise an at least one cleaning arm defining a cleaning head capable of contacting a contact lens, and a cleaning arm movement means communicating with the cleaning arm, the cleaning arm movement means effecting movement of the cleaning head for cleaning a contact lens. The contact lens cleaning means may comprise two cleaning arms, each arm being capable of cleaning a contact lens contained within an eyepiece.

The cleaning arm movement means may comprise an electric motor to effect rotational movement of the cleaning arm about it’s longitudinal axis, and may be provided with an off centre gear which provides a vertically oscillating movement.

The contact lens cleaning means may comprise an ultrasonic cleaning means, for example an ultrasonic probe. Ultrasonic cleaning devices are well known to a person skilled in the art.

The contact lens cleaning means may be turned on or off or otherwise controlled by way of a control (e.g. a switch or button) located on the cleaning housing, and a user can thus clean contact lenses contained within the eyepieces by actuating the control.

The apparatus (for example the cleaning housing) may comprise a compartment for storage of contact lens cleaning solutions and/or other components. The body and cleaning housing may comprise a compartment in which batteries may be stored, the batteries being used to power the apparatus.

The present invention in its various aspects also provides the opportunity to incorporate medical testing equipment for testing at least one eye of a patient. For example the apparatus may incorporate equipment to test a patient for glaucoma. Visual field test means may be incorporated into the apparatus, enabling a visual field test to be performed using it. For example, at least part of the visual field test means may be incorporated into the body of the apparatus. The visual field test means could be provided in the form of equipment for operation by a qualified optician or physician, or could be in the form of equipment for home use and which in the case of an adverse result being obtained can advise a user to seek medical advice to determine whether they are suffering from glaucoma. Other testing equipment is well known in the art and can be incorporated with the apparatus of the present invention. In particular, the present invention is well suited to testing equipment which requires clear access to at least one eye of a patient.

The apparatus can also provide convenient means for advising a user regarding the changing of contact lenses. For example, the apparatus may be adapted such that after a pre-defined number of insertions and removals of a given contact lens the user is advised (for example by the displaying of a message or lighting up of a warning light) that the contact lens needs replacing. As discussed below, messages may be displayed to a user (for example by way of a colored light) during use of the apparatus. Alternatively, instead of determining whether a pre-defined number of insertions and removals has been performed, a message may be displayed when a certain period of use (e.g. one week or one month) of a lens has elapsed. The apparatus may be provided with data input means to allow the setting and re-setting of necessary information, for example the start date of use of a lens or the number of uses of a lens. The apparatus may additionally be adapted such that for example in the case where multiple heads are to be used with one body, each head can be distinguished by the body and messages appropriate to that head issued. Alternatively, a head may contain within it the means for determining its use and issuing messages etc.

According to a second aspect of the present invention there is provided a method of inserting or removing at least one contact lens into or from an eye of a user using an apparatus for manipulation of a contact lens, said apparatus comprising an at least one eyepiece and an at least one body, said at least one eyepiece when attached to said at least one body defining an opening into said at least one body and said at least one eyepiece comprising: (i) a head for engaging a contact lens; and (ii) an eyelid opening means,

said at least one body containing a contact lens manipulation means comprising an elongate arm defining a longitudinal axis and an arm movement means communicating with said arm, said arm movement means effecting movement of said arm between a retracted position and an extended position;

said apparatus arranged such that when said at least one eyepiece is attached to said at least one body and the face of a user is in contact with said at least one eyepiece, an eyeball and upper and lower eyelids of said user being positioned over said opening, said eyelid opening means is engageable with said upper and lower eyelids to retain them open, said arm being engaged with said head and being extendable to contact said eyeball of said user and effect insertion and removal of a contact lens into and from said eye;

said method comprising the steps of: (i) contacting the face of a user with said at least one eyepiece, an eyeball and upper and lower eyelids of the user being positioned over said opening; (ii) operating said apparatus so as to engage said upper and lower eyelids and retain them open and extend said arm engaged with said head to contact said eyeball of said user and effect insertion or removal of a contact lens into or from said eye.

Also provided is a method of inserting or removing at least one contact lens according to the second aspect of the present invention, the apparatus additionally comprising a cleaning housing comprising contact lens cleaning means and being engageable with the eyepiece, such that when the at least one eyepiece and cleaning housing are engaged, the contact lens cleaning means can effect cleaning of a contact lens engaged with the head of the eyepiece, the method additionally comprising the steps of: (i) engaging the cleaning housing with the at least one eyepiece having a contact lens engaged with the head; (ii) operating the apparatus so as to effect cleaning of a contact lens engaged with the head of the eyepiece.

The various aspects and features of the apparatus of the present invention equally apply to the methods of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by way of example only with reference to the accompanying drawings in which:

FIG. 1 shows a shows a sectional view of the apparatus according to the present invention;

FIG. 2 shows a sectional view of the eyelid opening means contained within the eyepiece of the apparatus, (a) prior to contact with the eyelids of a user, (b) contacting the eyelids of a user, and (c) retaining the eyelids of a user in an open position;

FIG. 3 shows a plan view of the contact lens manipulation means of the apparatus with the arm contacting the head of the eyepiece;

FIG. 4 shows a side view of the stages in the removal of a contact lens from an eye, (a) at the moment when the head of the eyepiece contacts the contact lens, (b) retraction of the arm/sleeve and uncoupling of the sleeve and arm, (c) retraction of the arm relative to the sleeve causing deformation of the head and effecting gripping of the contact lens by the head, and (d) coupling of the arm and sleeve and retraction of the coupled arm/sleeve into the body;

FIG. 5 shows a side view of the stages in the cleaning of a contact lens contained within the apparatus according to the present invention, (a) prior to addition of cleaning solution, (b) after addition of cleaning solution, and (c) during cleaning of the contact lens by the contact lens cleaning means; and

FIG. 6 shows an alternative embodiment to that shown in FIG. 1, with an alternative arm movement means.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In a first embodiment of the invention, the apparatus 10 comprises two eyepieces 50 which are removeably attachable to a body 40 (FIG. 1). Only one of the eyepieces 50 may be attached to the body 40 at any given time. The eyepieces 50 are also releasably engageable with a cleaning housing 20 (FIG. 5C). Each eyepiece 50, when attached to the body 40, defines an opening 60 into the body 40 of the apparatus 10.

In a second embodiment of the invention, the apparatus 10 comprises two eyepieces 50, two bodies 40 and a cleaning housing 20, wherein each of the eyepieces 50 is attached to a body 40. The eyepieces 50 are also releasably engageable with a cleaning housing 20.

Each eyepiece 50 defines an opening 60 into the body 40 of the apparatus 10.

The eyepieces 50 each comprise an eyelid opening means 70 and a head 120 for engaging a contact lens 130 (FIG. 2). The eyelid opening means 70 comprises a plurality of eyelid opening arms 80, each of the eyelid opening arms 80 being movable within a guide track 150 positioned within the eyepieces 50, wherein the eyelid opening arms 80, responsive to contact against the upper and lower eyelids 95 of a user (FIG. 2A), move along the guide tracks 150 (FIG. 2B) engaging and retaining the upper and lower eyelids 95 in an open position (FIG. 2C). The eyepieces 50 of the apparatus 10 extend around the eyelid opening means 70, thereby protecting it from damage. The eyepiece 50 is sprung such that when it is pressed against the face of a user, the eyepiece 50 retracts towards the body 40 of the apparatus 10 and the eyelids 95 of the user contact the eyelid opening means 70.

Arms 80 are spaced so as to not contact the eyeball 160 of a user. The eyelid opening means 70 serves to prevent blinking during insertion and removal of a contact lens 130.

The head 120 of the eyepiece 50 can engage a contact lens 130.

With the face of a user in contact with eyepiece 50, the user is prevented from seeing external light (i.e. light is prevented from entering between the face of the user and the eyepiece).

The body 40 comprises a contact lens manipulation means 90 (FIG. 3) comprising an elongate arm 100 defining a longitudinal axis and an arm movement means 110, communicating with the arm 100. The arm 100 can engage with the head 120 contained within the eyepiece 50. The arm movement means 110 is capable of effecting movement of the arm 100 between a retracted position, wherein the arm 100 is contained within the body 40 and an extended position, wherein the arm 100 extends through the opening 60, engages with the head 120 contained in the eyepiece 50, and causes the head 120 to contact the eyeball 160 of the user and effect insertion and removal of a contact lens 130 into and from an eye (FIG. 3).

Each eyepiece 50 or body 40 comprises a light source (not shown) such that when a user looks through the eyepiece 50 into the opening 60 of the apparatus 10, the user sees a small focussed spot of light, thereby preventing the user from seeing the arm 100 and the head 120 of the apparatus 10. The inability of the user to see the components of the apparatus 10, both in a static or moving state minimizes flinching by the user and facilitates insertion and removal of contact lenses. The spot of light can be colored to indicate either normal function or to prompt the user to change the batteries of the device, or their contact lenses.

The contact lens manipulation means 90 comprises a rack 170 associated with the arm 100, the rack 170 engaging with a worm 180 associated with the arm movement means 110.

The contact lens manipulation 90 means comprises an electric motor 190 to effect movement of the arm 100 between extended and retracted states. A plurality of gears 195 are provided to improve the control of the arm 100 and the range of speed available for extension and retraction of the arm 100.

The arm 100 travels along the worm 180 in either direction responsive to rotation of the worm 180 about it’s longitudinal axis in one or other direction. Movement of the arm 100 along the worm 180 in one direction corresponds to extension of the arm 100 such that the head 120 extends through the opening 60, and movement of the arm 100 in the other direction along the worm 180 corresponds to retraction of the arm 100, such that it is fully contained within the body 40 of the apparatus 10. The worm 180 is provided with a stop 200 at one or both ends to limit movement of the arm 100. The arm 100 may be extended and retracted through the opening 60 of the apparatus 10 by traveling along the worm 180, and the extension and retraction can be controlled by a user. In one embodiment of the invention (see FIG. 3), the head 120 of each eyepiece 50 comprises a laser reader 205 which accurately measures the distance between the eyeball 160 (i.e. the point of contact) and the head 120 of the eyepiece 50. The apparatus 10 is fitted with a chip 208 located on a circuit board 209 which controls movement of the arm 100 in response to this measured distance approaching a set parameter. At this point the apparatus 10 moves the arm 100 in a tightly controlled and precise way, thereby inserting the contact lens 130 into the eye in an extremely accurate and safe manner. Movement of the arm 100 along the worm 180 is in response to operation of the apparatus 10 by a user. Apparatus 10 comprises a button 310 (FIG. 1) located on the body 40 to be depressed by a user in order activate movement of the arm 100.

The same apparatus 10 fitted with a laser reader 205, which measures the distance between the eyeball 160 and the head 120 of the eyepiece 50 in real time, is useable by a multitude of users, for example, all the members of a family who wear contact lenses. In one embodiment of the invention, the apparatus 10 is fitted with a chip 208 which contains the precise measurements for extension of the arm 100, as determined by e.g. an optician, such that the apparatus 10 can quickly and safely insert a contact lens 130 into the eye of a user, and that user can have the utmost confidence that the apparatus 10 can insert a contact lens 130 safely, since the apparatus 10 is tailored to insert a contact lens 130 in accordance with precise measurements of their facial and eye anatomy.

The head 120 of each eyepiece 50 is resiliently deformable, defining first extended, and second contracted positions, wherein the head 120 is capable of gripping a contact lens 130 when the head 120 is in the second position. The head 120 of each eyepiece 50 is cup shaped to complement the shape of a contact lens 130 or comprises a plurality of gripping arms 140 e.g. two, three or four. Head 120 is manufactured from a resiliently deformable material such as a low shore factor thermoplastic elastomer (TPE). The head 120 and gripping arms 140 are moulded to facilitate gripping or pinching of a contact lens 130 when the head 120 is in the second (contracted) position.

The contact lens manipulation means 90 comprises a head manipulating means 210 to effect gripping of a contact lens 130 by the head 120 of an eyepiece 50, to facilitate removal of a contact lens 130 from the eye or its packaging. The head manipulating means 210 comprises a longitudinally elongate sleeve 215 positioned coaxial with and radially extended from the arm 100. The sleeve 215 defines first and second ends 220,230, the arm 100 being positioned radially inwards of the sleeve 215 and defining a head-contacting end 217, the first end 220 of the sleeve 215 terminating adjacent to the head-contacting end 217 of the arm 120. The head 120 and arm 100 are movable relative to the sleeve 215 along the longitudinal axis between a first position in which the head 120 does not engage the sleeve 215 and is in the first extended state (FIGS. 4A and 4B), and a second position in which the head 120 engages the sleeve 215 and is deformed into the second contracted state, thereby effecting gripping of a contact lens 130 (FIGS. 4C and 4D).

The sleeve 215 and the arm 100 are reversibly coupled to one another and the head manipulating means 210 comprises a coupling control means 240 which is capable of coupling and uncoupling the sleeve 215 and the arm 100 between coupled and uncoupled states. In the coupled state the arm 100 moves in conjunction with the sleeve 215, and in the uncoupled state the arm 100 moves independently of the sleeve 215. When the head 120 contacts the eyeball 160, the sleeve 215 and the arm 100 become uncoupled (FIG. 4B) such that the arm 100 can retract independently of the sleeve 215. Upon retraction of the arm 100, the head 120 contacts the first end 220 of the sleeve 215, and further retraction of the arm 100 causes the first end 220 of the sleeve 215 to deform the head 120 from the first position to the second position and thereby effect gripping of a contact lens 130 (FIG. 4C).

The coupling control means 240 is electronic or electromagnetic. Coupling control means 240 is operatively linked to arm movement means 110 such that sleeve 215 and arm 100 are automatically uncoupled when head 120 contacts a contact lens 130 placed in position on the eyeball 160, prior to retraction of arm 100 and gripping of contact lens 130.

Retraction of arm 100 through sleeve 215 is only a short distance, between 0.3-2.0 cm.

Retraction of arm 100 is controlled so as to prevent head 120 and contact lens 130 being pulled through first end 220 of sleeve 215 and preventing damage. The distance of retraction of arm 100 is sufficient to deform head 120 from a first position to a second position such that contact lens 130 is gripped by head 120, then sleeve 215 and arm 100 are coupled together again, prior to full retraction of coupled arm 100 and sleeve 215 back into body 40 of apparatus 10.

As the coupled arm 100 and sleeve 215 retract into the body 40, the arm 100 disengages from the head 120 leaving it in the eyepiece 50, thereby allowing the head 120 to revert from the second (contracted) position where the contact lens 130 is gripped or pinched, to the first (extended) position, where the contact lens 130 is merely supported by the head 120.

In a second embodiment of the invention, the arm does not disengage from the head. To release the grip on the contact lens, the sleeve 215 is automatically uncoupled from the arm, and the arm 100 extends independently of the sleeve 215 until the head 120 returns from the second (contracted) position, in which the contact lens 130 is gripped, to the first (extended) position, in which the contact lens 130 rests on and is supported by the head 120.

The apparatus comprises a three way micro switch 330 which controls the three modes of action-namely, (i) insertion/removal of a contact lens into or from an eye of a user, (ii) installation of a contact lens into an eyepiece 50, and (iii) removal of a contact lens from an eyepiece 50.

In a first embodiment of the invention, the micro switch 330 is activated by attaching an eyepiece 50 onto the body 40, and securing it in position with clips provided (not shown).

The body 40 can distinguish which eyepiece 50 is being used, where one eyepiece 50 contains a contact lens 130 designed for use with the right eye, and the other eyepiece 50 contains a contact lens 130 designed for use with the left eye. A light or audible signal is relayed to the user to inform them which eye they need to position over the eyepiece 50 in order to install/remove the correct contact lens.

In a second embodiment of the invention, where the eyepieces 50 are each attached to a separate body 40, the micro switch 330 for each body 40 is activated through the use of an external switch positioned on each body 40.

A button 310 is positioned on the external surface of the body 40, for use by a user to control the contact lens manipulation means 90. By depressing the button, a user can thus use the body 40 to e.g. install a contact lens 130 into their eye, or remove a contact lens 130 from its packaging and install it into an eyepiece 50.

The cleaning housing 20 (FIG. 5C) of the apparatus 10 comprises a contact lens cleaning means 250, comprising an at least one cleaning arm 260 defining a cleaning head 270, and a cleaning arm movement means (not shown) communicating with the cleaning arm 260.

The cleaning housing 20 is engageable with eyepieces 50, such that when the cleaning housing 20 is engaged with an eyepiece 50, the contact lens cleaning means 250 can effect cleaning of the contact lens 130 contained within either of the eyepieces 50. The cleaning arm movement means comprises an electric motor (not shown) which is capable of effecting rotational movement of the cleaning head 270 for cleaning a contact lens 130, by effecting rotational movement of the cleaning arm 260 about it’s longitudinal axis, and is provided with an off centre gear (not shown) which provides a vertically oscillating movement. Contact lens cleaning means 250 is controlled by switch or button (not shown) located on the cleaning housing 20, and a user can thus clean contact lenses contained within the eyepieces 50 by flicking the switch or pressing the button.

Cleaning housing 20 comprises a compartment for storage of contact lens cleaning solutions and components. The body 40 and cleaning housing 20 comprise a compartment in which batteries may be stored, the batteries being used to power electric motors contained within the apparatus 10.

The body 40, eyepieces 50, and/or cleaning housing 20 of the apparatus 10 comprise at least one compartment for storage of spare contact lenses and cleaning solutions and components. The body 40, eyepieces 50 and cleaning housing 20 are manufactured from injection moulded plastic.

As is shown in FIG. 6, in another embodiment of the present invention the contact lens manipulation means 90 comprises an arm movement means 400 comprising an actuator/drive according to EP 0784252, EP 0534786 and EP0778656 which facilitates movement of the arm and the measurement of forces felt against the arm 100 in real time, such that a contact lens 130 may be manipulated with a high degree of precision, and regulated force. When the arm 100 meets a predefined level of resistance, i.e. as it contacts the eyeball 160, it stops quickly and accurately such that there is no risk of the apparatus 10 damaging the eye of a user, thereby enhancing user confidence with the apparatus 10.

EXAMPLES

The following examples detail the various functions that the apparatus 10 according to the present invention can perform.

Removal of Contact Lenses from their Packaging and Installation of Contact Lenses into the Apparatus.

A contact lens 130, immersed within an appropriate storage solution within its packaging can be installed into an eyepiece 50 by pressing the button 310 located on the body 40. A single extended press of the button 310 by a user will trigger the cycle of movements which enable a contact lens 130 to be installed into an eyepiece 50 of the apparatus 10.

The first stage in this cycle is an extension of the arm 100 of the contact lens manipulation means 90 through the opening 60 until the arm 100 engages the head 120 within the eyepiece 50. The arm 100 continues to extend until the head 120 contacts the contact lens 130, at which the point the extension of the arm 100 will precisely stop. Next, the sleeve 215 is automatically uncoupled from the arm, and the arm 100 retracts independently of the sleeve 215 until the head 120 is deformed from the first (extended) position to the second (contracted) position, thereby effecting gripping of the contact lens 130. Then, the arm 100 and the sleeve 215 are automatically coupled, and the arm 100 and sleeve 215 retract until the head 120 disengages from the arm 100, leaving it in the eyepiece 50.

When the head 120 disengages from the coupled arm/sleeve, the head 120 returns from the second (contracted) position (in which the contact lens 130 is gripped) to the first (extended) position, in which the contact lens 130 rests on and is supported by the head 120. The coupled arm/sleeve continues to retract until it is fully contained within the body 40.

Retention of Eye Lids

The eyelid opening means 70 is activated when a user, looking into the opening 60 of the eyepiece 50, contacts the eyepiece 50 against their eyelids 95. The eyepiece 50 is sprung so that it retracts when pressed against the eyelids 95, and as it retracts the arms of the eyelid opening means 70 can contact the eyelids 95. As the eyepiece 50 fully retracts, the arms of the eyelid opening means 70 move along paths defined by guide tracks 150 such that the eyelids 95 are gently moved into an open position, and retained in that position prior to insertion and removal of a contact lens 130 into or from the eye. The pressure is controlled by the user, helping them feel as though they are in control.

Insertion of Contact Lenses into an Eye

A contact lens 130, immersed within an appropriate storage or cleaning solution within an eyepiece 50 and being positioned on the head 120 of the eyepiece 50 may be inserted into the eye by pressing the button 310 located on the body 40. The user looks into the opening 60 of the eyepiece 50 and the eyelid opening means 70 retains the eyelids 95 in an open position. A single press of the button 310 will trigger the cycle of events which leads to insertion of the contact lens 130 into the eye of the user. The first step is an extension of the arm 100 through the opening 60 until the arm 100 engages the head 120 of the eyepiece 50. The arm 100 extends further until the contact lens 130 contacts the eyeball 160. The extension of the arm 100 is controlled and stopped when the contact lens 130 touches the eyeball 160. Upon contact with the eyeball 160, the contact lens 130 is sucked onto the eyeball 160 through capillary action of the solution on the contact lens 130. After insertion of the contact lens 130, the arm 100 is automatically retracted, disengaging from the head 120, and retracted further until it is fully contained within body 40 of the apparatus 10.

Removal of Contact Lenses from an Eye

Following insertion of a contact lens 130 into an eye, a single press of the button 310 located on the body 40 will trigger the cycle of events which leads to removal of the contact lens 130 from the eye of the user. The user looks into the opening 60 of the eyepiece 50 and the eyelid opening means 70 retains the eyelids 95 in an open position.

Following the pressing of the button, in the first step, the arm 100 and sleeve 215 are automatically coupled, and the coupled arm/sleeve extends through the opening 60 until the arm 100 engages the head 120. The coupled arm/sleeve continues to extend until it contacts the contact lens 130 positioned on the eyeball 160. The extension of the arm 100 is controlled and stopped when the head 120 encounters a programmed amount of resistance as it touches the contact lens 130 positioned on the eyeball 160. The arm/sleeve retracts a short distance, and then the arm 100 and sleeve 215 are uncoupled. The arm 100 then retracts a set distance until the head 120 is deformed from the first (extended) position to the second (contracted) position, thereby gripping the contact lens 130. As the contact lens has been in the eye for a day the moisture content has lowered, resulting in the contact lens 130 becoming tacky to the touch and thereby facilitating the removal process. The arm 100 and the sleeve 215 are then coupled together and they retract until the head 120 is contained within the eyepiece 50, and then the arm 100 continues to retract until it is contained within the body 40, leaving the head 120 (and the contact lens 130) in the eyepiece 50.

Cleaning of Contact Lenses

Cleaning solution is applied to a contact lens 130 contained within an eyepiece 50. The cleaning solutions are held within the cleaning housing 20. The contact lens 130 can be cleaned by engaging the cleaning housing 20 with an eyepiece 50 or eyepieces 50. The eyepiece 50 does not have to be attached to the body 40, although cleaning can be performed if the eyepiece 50 is attached to the body 40. Engaging the cleaning housing 20 with one or more eyepieces 50 or eyepieces 50 creates a seal which prevents the contact lens 130 being exposed to dust or micro-organisms. By pressing the button (not shown) located on the cleaning housing 20, a user activates an electric motor (not shown) which is attached to an off centre gear which causes both rotation of the cleaning heads 270 and a vertically oscillating movement. The cleaning last for approximately 30 seconds, after which the contact lens 130 is clean. The solution is automatically drained out of the eyepiece 50, leaving the contact lens 130 substantially solution free to be inserted into an eye.

Storage of Contact Lenses

Contact lenses may be stored in the eyepiece 50 either before or after cleaning by adding a storage solution (e.g. sterile saline) to the eyepiece 50 to keep the contact lens 130 wet. Prior to insertion into an eye, the contact lenses may be cleaned.