Corneal onlays

• US 5,713,957 A
• Filed: 05/16/1996
• Issued: 02/03/1998
• Est. Priority Date: 11/19/1993
• Status: Expired due to Term

• Current Assignee: Commonwealth Scientific & Industrial Research Organisation (Commonwealth Of Australia As Represented By Department Of Industry, Innovation, Climate Change, Science, Research And Tertiary Education), CIBA Vision Corporation (Novartis Ag)
• Original Assignee: Commonwealth of Australia Commonwealth Scientific and Industrial Research Organizaton, CIBA Vision Corporation (Novartis Ag)
• Inventors: Vannas, Antti, Holden, Brien A., O'Leary, Dan, Schindhelm, Klaus, Sweeney, Deborah, Johnson, Graham, Steele, John Gerard
• Primary Examiner(s): JONES, MARYBETH O
• Application Number:
  US08/646,287
• Time in Patent Office: 628 Days
• Field of Search: 623/5, 351/160 C
• US Class Current: 623/5.16
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2/145 Corneal inlays, onlays, or lenses for refractive correction
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

Corneal onlays for use in surgical implantation into or onto the cornea of a mammal are described. The corneal onlays according to the invention have an optical axis region with optical characteristics which provide visual acuity therethrough and are comprised of a non-biodegradable non-hydrogel ocularly biocompatible material, characterized in that the onlay has a porosity sufficient to allow passage therethrough of tissue fluid components having a molecular fluid weight greater than 10,000 daltons so as to provide for a flux of tissue fluid between cells anterior of the implanted onlay and cells posterior thereof. The porosity of the optical axis region is such that it allows the flux of tissue fluid components whilst excluding ingrowth of ocular tissue. The onlay is further characterized by being adapted for epithelial recolonization. Also described are methods for correcting the optical property of an eye or altering the appearance thereof which comprises surgically implanting into or onto the cornea a corneal onlay as described above.

Claims

1. A corneal onlay for use in surgical implantation into or onto the cornea of a mammal, said onlay having an optical axis region with optical characteristics which provide visual acuity therethrough, said onlay being comprised of a non-biodegradable non-hydrogel ocularly biocompatible material, and characterized in that said onlay has a porosity sufficient to allow passage therethrough of tissue fluid components having a molecular weight greater than 10,000 daltons, thereby providing for a flux of tissue fluid between cells anterior of the implanted onlay and cells posterior thereof, wherein the porosity of the optical axis region is such that it allows the flux of tissue fluid components whilst excluding ingrowth of ocular tissue, and wherein said onlay is adapted for epithelial recolonization.

2. A corneal onlay according to claim 1 wherein the periphery of the onlay surrounding the optical axis region defines a skirt having a porosity sufficient to permit ingrowth of ocular tissue so as to facilitate anchoring of the onlay to the cornea.

3. A corneal onlay according to claims 1 or 2 wherein the surface of the onlay is modified so as to stimulate the adhesion of cells adjacent to the implanted onlay.

4. A corneal onlay according to claim 2 wherein the onlay is coated with one or more components which promote the growth of tissue adjacent to the implanted onlay, and/or cell adhesion to the onlay.

5. A corneal onlay according to claim 1 wherein porosity of the onlay is provided by a plurality of pores having a size sufficient to allow passage through the onlay of proteinaceous tissue fluid components having a molecular weight greater than 10,000 daltons but which excludes tissue ingrowth.

6. A corneal onlay according to claim 2 wherein porosity of the visual optical axis is provided by a plurality of pores having a size sufficient to allow passage through the onlay of proteinaceous tissue fluid components having a molecular weight greater than 10,000 daltons but which excludes tissue ingrowth.

7. A corneal onlay according to claims 5 or 6 wherein said plurality of pores comprise a diameter from 15 nanometers to 0.5 micrometers.

8. A corneal onlay according to claim 7 wherein said plurality of pores comprise a diameter from 15 nanometers to 300 nanometers.

9. A corneal onlay according to claim 8 wherein said plurality of pores comprise a diameter from 20 to 150 nanometers.

10. A corneal onlay according to claim 2 wherein said porosity of the skirt is defined by a plurality of pores having a diameter of at least 20 microns so as to allow tissue ingrowth and anchorage of the onlay.

11. A corneal onlay according to claim 10 wherein the skirt is formed of a different biocompatible non-biodegradable material than the optical axis region, and wherein said skirt is either integral with the optical axis region or secured to the periphery thereof.

26. A corneal onlay as claimed in claim 1 for use in a method as claimed in claim 12.

12. A method for correcting the optical properties of an eye or altering the appearance thereof comprising surgically implanting into or onto the cornea a corneal onlay having optical characteristics which provide visual acuity therethrough, said onlay being comprised of a corneal onlay for use in surgical implantation into or onto the cornea of a mammal, said onlay having an optical axis region with optical characteristics which provide visual acuity therethrough, said onlay being comprised of a non-biodegradable non-hydrogel ocularly biocompatible material, and characterized in that said onlay has a porosity sufficient to allow passage therethrough of tissue fluid components having a molecular weight greater than 10,000 daltons, thereby providing for a flux of tissue fluid between cells anterior of the implanted onlay and cells posterior thereof, wherein the porosity of the optical axis region is such that it allows the flux of tissue fluid components whilst excluding ingrowth of ocular tissue, and wherein said onlay is adapted for epithelial recolonization.

13. A method according to claim 12 wherein the periphery of the onlay surrounding the optical axis region defines a skirt having a porosity sufficient to permit ingrowth of ocular tissue so as to facilitate anchoring of the onlay to the cornea.

14. A method according to claim 12 wherein the surface of the onlay is modified so as to stimulate the adhesion of cells adjacent to the implanted onlay.

15. A method according claim 12 wherein the onlay is coated with one or more components which promote the growth of tissue adjacent to the implanted onlay, and/or cell adhesion to the onlay.

16. A method according to claim 12 wherein porosity of the onlay is provided by a plurality of pores having a size sufficient to allow passage through the onlay of proteinaceous tissue fluid components having a molecular weight greater than 10,000 daltons but which excludes tissue ingrowth.

17. A method according to claim 13 wherein porosity of the visual optical axis is provided by a plurality of pores having a size sufficient to allow passage through the onlay of proteinaceous tissue fluid components having a molecular weight greater than 10,000 daltons but which excludes tissue ingrowth.

18. A method according to claims 16 or 17 wherein said plurality of pores comprise a diameter between 15 nanometers to 0.5 micrometers.

19. A method according to claim 18 wherein said plurality of pores comprise a diameter between 15 nanometers to 300 nanometers.

20. A method according to claim 18 wherein said plurality of pores comprise a diameter between 20 to 150 nanometers.

21. A method according to claim 13 wherein said porosity of the skirt is defined by a plurality of pores having a diameter of at least 20 microns so as to allow tissue ingrowth and anchorage of the onlay.

22. A method according to claim 13 wherein the skirt is formed of a different biocompatible non-biodegradable material than the optical axis region, and wherein said skirt is either integral with the optical axis region or secured to the periphery thereof.

23. A method according to claim 12 wherein said onlay is transplanted into the epithelium of the cornea.

24. A method according to claim 23 wherein the onlay is positioned adjacent the basement membrane of the cornea.

25. A method according to claim 13 wherein the optical axis region is coloured.