Sterilization of intraocular lenses
View Patent ↗A packaged, sterilized intraocular lens prepared by a process comprising providing a hydrophobic acrylic, or low water acrylic, intraocular lens and positioning the acrylic lens in a lens enclosure with an aqueous solution to provide a lens package. The lens package is then heated to a temperature sufficient for sterilization, however, the heating of the lens package must begin before the acrylic lens reaches an equilibrated, hydrated state following contact of the lens with the aqueous solution. The resulting sterilized acrylic intraocular lens will have less than sixty percent of total volume of disc-like features, or less than forty percent of total volume of water vacuoles, after 60 days following sterilization compared to an acrylic lens of the same composition, which was sterilized under the same conditions, but in an equilibrated, hydrated state.
1. A sterilized intraocular lens prepared by a process comprising:
providing a hydrophobic acrylic, or low water acrylic, intraocular lens and positioning the acrylic lens in a lens enclosure with an aqueous solution to provide a lens package; and
heating the lens package to a temperature sufficient for sterilization, wherein the heating of the lens package must begin before the acrylic lens reaches an equilibrated, hydrated state following contact of the lens with the aqueous solution, said sterilized intraocular lens to have less than sixty percent of total volume of disc-like features after 60 days following sterilization compared to an acrylic lens of the same composition that was sterilized under the same conditions, but in an equilibrated, hydrated state.
2. The sterilized lens of claim 1 wherein the acrylic lens comprises acrylate or methacrylate monomeric units with aromatic functionality.
3. The sterilized lens of claim 1 wherein the acrylic lens comprises silicon monomeric units.
4. The sterilized lens of claim 1 wherein the providing of the acrylic intraocular lens includes extracting the acrylic intraocular lens with a low-expanding organic solvent to remove unwanted polymerization products or non-reacted monomer from the lens.
5. The sterilized lens of claim 4 wherein the providing of the acrylic intraocular lens includes drying a solvent-extracted lens under vacuum at temperatures from 40° C. to 110° C. for at least thirty minutes.
6. The sterilized lens of claim 1 wherein said sterilized intraocular lens has less than thirty percent of total volume of disc-like features after 60 days following sterilization compared to the lens of the same composition that was sterilized under the same conditions, but in an equilibrated, hydrated form.
7. The sterilized lens of claim 1 wherein the lens package is sealed prior to heating.
8. The sterilized lens of claim 1 wherein the heating of the lens package begins within six hours of contacting the acrylic lens with the aqueous solution.
9. The sterilized lens of claim 8 wherein the heating of the lens package begins within two hours of contacting the acrylic lens with the aqueous solution.
10. The sterilized lens of claim 1 wherein the acrylic lens comprises acrylate or methacrylate monomeric units of formula III
wherein R is either hydrogen or CH 3 , R 1 is hydrogen, C 3 -C 12 alkyl with optional oxygen functionality selected from carboxy and monohydric or polyhydric alcohols.
11. A sterilized intraocular lens prepared by a process comprising:
providing a hydrophobic acrylic, or low water acrylic, intraocular lens and positioning the acrylic lens in a lens enclosure with an aqueous solution to provide a lens package; and
heating the lens package to a temperature sufficient for sterilization, wherein the heating of the lens package must begin before the acrylic lens reaches an equilibrated, hydrated state following contact of the lens with the aqueous solution, said sterilized intraocular lens to have less than forty percent of total volume of water vacuoles 60 days following sterilization compared to an acrylic lens of the same composition that was sterilized under the same conditions, but in an equilibrated, hydrated state.
12. The sterilized lens of claim 11 wherein the acrylic lens comprises acrylate or methacrylate monomeric units with aromatic functionality.
13. The sterilized lens of claim 11 wherein the hydrophobic intraocular lens comprises silicon monomeric units.
14. The sterilized lens of claim 11 wherein the heating of the lens package begins within six hours of contacting the acrylic lens with the aqueous solution.
15. The sterilized lens of claim 11 wherein the heating of the lens package begins within two hours of contacting the acrylic lens with the aqueous solution.
16. The sterilized lens of claim 11 wherein the acrylic lens comprises acrylate or methacrylate monomeric units of formula III
wherein R is either hydrogen or CH 3 , R 1 is hydrogen, C 3 -C 12 alkyl with optional oxygen functionality selected from carboxy and monohydric or polyhydric alcohols.
17. A hydrated, sterilized intraocular lens with less than sixty percent of total volume of disc-like features, the total volume of disc-like features determined 60 days following sterilization, the sterilization conducted in an aqueous solution and with the lens in a non-equilbrated hydrated state, compared to a lens of the same composition that was sterilized in the same aqueous solution, but in an equilibrated, hydrated state.
18. The sterilized lens of claim 17 wherein the sterilization conducted with the lens in a non-equilbrated hydrated state begins within six hours of contacting the acrylic lens with the aqueous solution.
19. A hydrated, sterilized intraocular lens with less than forty percent of total volume of water vacuoles, the total volume of water vacuoles determined 60 days following sterilization, the sterilization conducted in an aqueous solution and with the lens in a non-equilbrated hydrated state, compared to a lens of the same composition that was sterilized in the same aqueous solution, but in an equilibrated, hydrated state.
20. The sterilized lens of claim 19 wherein the sterilization conducted with the lens in a non-equilbrated hydrated state begins within six hours of contacting the acrylic lens with the aqueous solution.