One-piece minicapsulorhexis valve

• US 20040098122A1
• Filed: 11/18/2002
• Published: 05/20/2004
• Est. Priority Date: 11/18/2002
• Status: Active Grant

• Current Assignee: Brien Holden Vision Institute
• Original Assignee: The Institute For Eye Research
• Inventors: Ho, Arthur, Lee, William, Parel, Jean-Marie, Fernandez, Viviana
• Granted Patent: US 7,001,426 B2
• Time in Patent Office: Days
• US Class Current: 623/4.1
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery

Abstract

A one-piece capsulorhexis device is presented comprising a membrane having a curved, flexible substantially discoid flap-valve member shaped to align with an ocular lens capsular bag inner surface, and at least one integral, flexible retainer shaped to align with an ocular lens capsular bag outer surface.

Claims

1. A one-piece capsulorhexis device comprising:

a unitary flexible discoid section; and

an integral retainer having proximal and distal end, said distal end extending radially outward from the discoid portion.

2. The device according to claim 1, wherein the discoid portion is dimensionally in a shape selected from the group consisting of:

curved, flat, and circular.

3. The device according to claim 1, wherein the discoid portion is non-circular.

4. The device according to claim 1, wherein the device comprises a plurality of retainers integral with the discoid portion, each retainer extending radially outward from the discoid section.

5. The device according to claim 1, wherein the discoid portion has a diameter of from about 1.0 to about 6.0 mm.

6. The device according to claim 1, wherein the discoid portion comprises a peripheral region and a central region, wherein the thickness of the peripheral region is greater than the thickness of the central region.

7. The device according to claim 1, wherein distal end has a width of from about 0.3 to about 1.5 mm.

8. The device according to claim 1, wherein the retainer has a length of from about 2.0 to about 4.0 mm.

9. The device according to claim 1, wherein the retainer further comprises an aperture in the distal end.

10. The device according to claim 9, wherein the aperture is substantially circular.

11. The device according to claim 9, wherein the aperture is a substantially rectangular slit.

12. The device according to claim 1, wherein the device has a thickness of from about 0.010 mm to about 0.150 mm.

13. The device according to claim 1, wherein the device has a curvature that is substantially similar to the curvature of an inner surface of an ocular lens capsular bag.

14. The device according to claim 1, wherein the device is sufficiently flexible to conform to the shape of a surface to which it is applied.

15. The device according to claim 1, wherein the device is made from a biocompatible elastomer.

16. The device according to claim 1, wherein the device is made from a synthetic polymer.

17. The device according to claim 1, wherein the device is made from an organic polymer.

18. The device according to claim 1, wherein the device is made from a sterilizable material.

19. The device according to claim 1, wherein the device is impregnated with a therapeutic agent.

20. The device according to claim 19, wherein the therapeutic agent is dispersed from the device.

21. The device according to claim 19, wherein the therapeutic agent is time-released.

22. The device according to claim 19, wherein the therapeutic agent is released by photo-activation.

23. The device according to claim 15, wherein the biocompatible elastomer is selected from the group consisting of:

urethanes, silicones, cross-linkable polydimethylsiloxanes, cross-linkable dimethyldiphenylsiloxanes, polyacrylamides, poly-N-vinylpyrrolidones, hydroxyalkylacrylates, hydroxyethylmethacrylate, poly-tetrafluoroethylene, polyethylene, and polyethyleneglycol diacrylate.

24. The device according to claim 15, wherein the biocompatible elastomer comprises a biodegradable material capable of biodegradation upon photoactivation.

25. The device according to claim 15, wherein the biocompatible elastomer is selected from the group consisting of collagen, collagen derivatives, processed amniotic membrane material, cross-linked sodium hyaluronate, cross-linked polysaccharides and mixtures thereof.

26. The device according to claim 15, wherein the biocompatible elastomer comprises a 10 to 80 Shore A durometer medical grade crosslinkable trimethyl polydimethylsiloxane.

27. The device according to claim 15, wherein the elastomer is transparent to radiation of a wavelength of from about 300 nm to about 1100 nm.

28. The device according to claim 15, wherein the elastomer is transparent to radiation of a wavelength of from about 300 nm to about 400 nm.

29. The device according to claim 15, wherein the elastomer is transparent to radiation of a wavelength of from about 400 nm to about 700 nm.

30. The device according to claim 15, wherein the elastomer is transparent to radiation of a wavelength of from about 700 nm to about 1100 nm.

31. The device according to claim 1, wherein the discoid portion has a central region and a peripheral flange.

32. The device according to claim 31, wherein the peripheral flange has a greater thickness than the central region.

33. The device according to claim 31, wherein the central region has a greater thickness than the peripheral flange.

34. The device according to claim 1, wherein the device is implantable in mammals.

35. The device according to claim 34, wherein the device is removable after implantation.

36. The device according to claim 1, wherein the device further comprises an alignment indicia.

37. A unitary capsulorhexis valve device comprising:

a membrane made from a material transparent to radiation, said membrane having a wavelength transmission of from about 300 nm to about 1100 nm, said material made from a biocompatible elastomer selected from the group consisting of urethanes, silicones, cross-linkable polydimethylsiloxanes, cross-linkable dimethyldiphenylsiloxanes, poly-acrylamides, poly-N-vinylpyrrolidones, hydroxyalkylacrylates, hydroxyethylmethacrylate, poly-tetrafluoroethylene, polyethylene, poly-ethyleneglycol diacrylate, collagen, collagen derivatives and mixtures thereof, said membrane having a discoid portion and at least one integral retainer, said retainer extending radially outward from the discoid portion.

38. A method of accessing an ocular lens comprising the steps of:

making a limbus incision to open an anterior chamber of an eye;

filling the anterior chamber with a viscoelastic solution;

creating an anterior capsulorhexis opening in a lens capsule; and

inserting into the opening a unitary flexible capsulorhexis valve device comprising a discoid portion having a periphery, and at least one integral flexible retainer such that the periphery of the device is positioned along an interior surface of the lens capsule and said flexible retainer is positioned along an outer surface of the lens capsule, positioning a wall of the lens capsule therebetween.

39. A method of accessing an ocular lens comprising the steps of:

making a limbus incision to open an anterior chamber of an eye;

filling the anterior chamber with a viscoelastic solution;

creating an anterior capsulorhexis opening in a lens capsule;

inserting into the opening a unitary flexible capsulorhexis valve device comprising a discoid portion having a periphery, and at least one integral flexible retainer such that the periphery of the device is positioned along an interior surface of the lens capsule and said flexible retainer is positioned along an outer surface of the lens capsule, positioning a wall of the lens capsule therebetween, said device impregnated with a therapeutic agent; and

dispersing the therapeutic agent from the device to the eye.