Method of correcting vision using corneal onlays

• US 9,125,735 B2
• Filed: 10/04/2010
• Issued: 09/08/2015
• Est. Priority Date: 04/04/2008
• Status: Expired due to Fees

• Current Assignee: Forsight Labs, LLC
• Original Assignee: Forsight Labs, LLC
• Inventors: de Juan, Eugene Jr., Reich, Cary J., Boyd, Stephen, Sierra, David, Alejandro, Jose D.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US12/897,131
• Publication Number:
  US 20110208300A1
• Time in Patent Office: 1,800 Days
• Field of Search: 623 511- 516, 623/4.1, 606/107
• US Class Current: 1/1
• 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 2/1451 Inlays or onlays
• CPC Class Codes: A61F 2/1453 Corneal lenses connected to distinct attachment means
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery

Abstract

A corneal onlay is configured to adhere to the cornea so as to inhibit epithelial growth under the onlay. Structures can be provided on the onlay to adhere the onlay to the eye. At least one of an epithelial layer or the water inhibiting layer can be provided on or over the onlay, for example a natural epithelial layer or water inhibiting layer that inhibits, for example minimizes, water penetration into the onlay, so as to adhere the onlay to the eye with pumping of the endothelium. The water inhibiting layer may comprise a therapeutic covering positioned over the onlay to inhibit swelling of the cornea. The posterior surface of the onlay may be shaped so as to fit the anterior exposed surface of the cornea.

Claims

1. A method of correcting vision comprising:

(a) obtaining an onlay configured to correct vision of an eye of a human and a separate therapeutic covering;

(b) placing the onlay on the cornea of an eye of a patient so as to correct vision of the eye; and

subsequently

(c) placing the covering on the cornea so that it covers and extends around the onlay, thereby promoting regeneration of epithelium between the covering and the onlay;

wherein the therapeutic covering is a solid covering device that comprises a water inhibiting layer, thereby configuring the covering to adhere to the cornea by endothelial cell suction.

2. The method of claim 1 wherein the onlay is positioned in an epithelial pocket with epithelium disposed between the onlay and the covering.

3. The method of claim 1 wherein the epithelium is debrided to expose the Bowman'"'"'s membrane and the onlay positioned on the Bowman'"'"'s membrane.

4. The method of claim 1,

further comprising:

(d) removing the covering once epithelium has regenerated between the covering and the onlay so as to at least partly cover the onlay.

5. The method of claim 4 wherein the covering when the covering is removed after about 4 days.

6. The method of claim 4, wherein removing the covering comprises administering water to the eye so as to loosen the covering from the epithelium of the eye.

7. The method of claim 1 wherein the covering is permeable to oxygen.

8. The method of claim 1 further comprising:

measuring the cornea; and

selecting the covering from among a plurality of coverings in accordance with data obtained from the measuring such that the seal is formed when the covering is placed on the cornea.

9. The method of claim 1, wherein the covering comprises a hydrophobic material facing the cornea.

10. The method of claim 1, wherein the covering comprises a hydrophilic outer surface.

11. The method of claim 1, wherein the covering is shaped to conform to irregularities of the epithelium, thereby adhering the covering and to adhere to the first portion and the onlay to the cornea.

12. The method of claim 1, wherein the covering comprises a thickness within a range from about 25 to about 100 microns and an oxygen Dk parameter of at least about 80.

13. The method of claim 1, wherein the covering comprises an outer portion configured to conform to the cornea so as to seal the covering over the cornea, and an non-conforming inner portion configured to retain an optical shape and smooth the cornea for vision.

14. The method of claim 1, wherein the covering conforms with one or more irregularities on the Bowman'"'"'s membrane and/or stromal tissue of the eye.

15. The method of claim 1, wherein the covering comprises a homogeneous material, wherein the outer portion comprises a thickness configured to conform with the cornea, and the inner portion comprises thickness configured to retain an optical shape.

16. The method of claim 1, wherein the covering comprises an inner portion and an outer portion, wherein the outer portion has a thickness of no more than about 100 microns tapering at the boundary with the inner portion to about 5 microns at the periphery of the outer portion.

17. The method of claim 1, wherein the covering has a hydrophobic layer or surface comprising silicone.

18. The method of claim 1, wherein the covering has a hydrophobic layer or surface comprising elastomer, silicone elastomer or polyurethane.

19. The method of claim 17, wherein the silicone has a water content within a range from about 0.1% to about 10%.

20. The method of claim 1, wherein the covering is molded with an outer material and an inner material, wherein the outer material has a hardness selected to conform with the cornea, and the inner portion has a hardness selected to retain an optical shape.

21. The method of claim 20, wherein the outer material has a Shore A durometer parameter between about 20 to about 40.

22. The method of claim 20, wherein the inner material has a hardness Shore A durometer parameter between about 40 to about 70.

23. The method of claim 1, wherein the covering comprises a rigid central portion of about 6 to 9 mm in diameter that confers an optical power when placed on the eye.

24. The method of claim 1, wherein the covering has an annular structure sized to an outer perimeter of the onlay so as to fit the onlay and the epithelium to inhibit epithelial growth under the onlay.

25. The method of claim 24, wherein the annular structure extends downward from the lower surface of the covering to fit the onlay and the epithelium.

26. The method of claim 1, wherein the onlay comprises a degradable material so that the onlay degrades within about one week of placement on the cornea.

27. The method of claim 26, wherein the degradable material comprises a material selected from the group consisting of poly-lactic acid (PLA), poly-glycolic acid (PGA) and PLA/PGA copolymer.

28. The method of claim 1, wherein the onlay comprises an anterior water inhibiting layer, and a posterior water permeable layer with a posterior surface shaped to fit an anteriorly exposed surface of the cornea.

29. The method of claim 1, wherein the covering is configured to detach from the onlay once the epithelium of the eye has regenerated between the onlay and the covering.

30. The method of claim 1, wherein the covering has a thickness of no more than about 200 microns and a width of at least about 5 mm to conform to the cornea and the onlay.

31. The method of claim 1, wherein the covering has a thickness within a range from about 25 to about 100 microns.

32. The method of claim 1, wherein the covering has an oxygen Dk parameter of at least about 80 Barrer.

33. A method of placing an onlay in an eye of a patient in need thereof, comprising:

(a) obtaining an onlay that is selected to improve vision of the eye;

(b) obtaining a separate therapeutic covering that comprises a water inhibiting layer that is sized and shaped to cover and surround the onlay when the onlay is placed in the eye;

(c) placing the onlay directly onto an anterior surface of the cornea;

then

(d) placing the therapeutic covering over the onlay such that the covering covers the onlay and the water inhibiting layer seals the covering to the cornea by suction, thereby promoting regeneration of epithelium between the covering and the onlay; and

subsequently

(e) removing the covering from the eye once epithelium has sufficiently regenerated over the onlay such that the onlay adheres to the surface without the covering.

34. The method of claim 33, wherein step (c) comprises placing the onlay under a flap surgically created in the cornea of the eye.

35. The method of claim 33, wherein step (c) comprises placing the onlay into a pocket made in the epithelium.

36. The method of claim 33, wherein step (c) comprises placing the onlay onto an area of the Bowman'"'"'s membrane of the eye that has been debrided of epithelium.

37. The method of claim 33, wherein the therapeutic covering comprises an annular structure sized to fit the onlay and the epithelium and configured to press downwards on the onlay near the periphery.

38. The method of claim 33, wherein the therapeutic covering comprises an inner portion and an outer portion with an annular structure disposed therebetween that corresponds to the diameter of the onlay.

39. The method of claim 33, wherein the therapeutic covering has a thickness that is less than the epithelium of the eye.

40. The method of claim 33, wherein the therapeutic covering comprises an outer portion configured to conform to the cornea so as to seal the covering over the corneal, and a non-conforming inner portion configured to retain an optical shape and to smooth the cornea for vision.

41. The method of claim 33, wherein the therapeutic covering comprises an outer hydrophilic surface and an inner hydrophobic surface.

42. The method of claim 33, whereby the therapeutic covering is removed after about 4 days.