Kit and method in eye surgery

• US 20040039399A1
• Filed: 05/15/2003
• Published: 02/26/2004
• Est. Priority Date: 05/16/2002
• Status: Active Grant

• Current Assignee: Amo Groningen B.V (Johnson & Johnson)
• Original Assignee: Amo Groningen B.V (Johnson & Johnson)
• Inventors: Norrby, Sverker, Bergman, Rolf, Hillborn, Jons
• Granted Patent: US 7,811,267 B2
• Time in Patent Office: Days
• US Class Current: 606/107
• CPC Class Codes: A61F 2/1616 Pseudo-accommodative, e.g. multifocal or enabling monovision
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/046 Fibrin; Fibrinogen
• CPC Class Codes: C09J 189/00 Adhesives based on proteins; Adhesives based on derivatives thereof

Abstract

A kit is provided, which comprises a) a collagen patch and b) an adhesive composition comprising (i) fibrin, fibrinogen or a combination thereof, and (ii) a biocompatible polymer capable of forming a viscous aqueous solution.

Also provided is use of the kit for the preparation of a sealing device for use in ophthalmic surgery to replace a natural lens which has been removed, in which sealing device the collagen patch of the kit is adapted to seal an opening in a capsular bag of an eye while admitting the entrance of an injection device through the opening for injection of a lens-forming material into the capsule; and in which sealing device the adhesive composition of the kit is adapted to be applied to the collagen patch so as to enable adhesion of the collagen patch to the capsular bag.

Also provided are methods for sealing an opening in a capsular bag of an eye, in which methods the kit is employed.

Claims

1. Kit comprising a) a collagen patch and b) an adhesive composition comprising (i) fibrin, fibrinogen or a combination thereof, and (ii) a biocompatible polymer capable of forming a viscous aqueous solution.

2. Kit according to claim 1, wherein said collagen patch is provided with a removable adjusting means connected to the collagen patch and capable of positioning said collagen patch to a desired location.

3. Kit according to claim 2, wherein the removable adjusting means is at least one flexible thread attached to the collagen patch.

4. Kit according to claim 3, wherein the at least one thread protrudes from the collagen patch.

5. Kit according to any one of the preceding claims, wherein the collagen patch is adapted to function as a septum to admit passage of an injection device through the patch.

6. Kit according to any one of claims 1-4, wherein the collagen patch has a cut adapted to admit passage of an injection device through the cut.

7. Kit according to claim 6, wherein the cut is provided with an overlapping part adapted to seal the cut when injection is completed.

8. Kit according to any one of the preceding claims, wherein the collagen patch has a thickness of 5-250 μ

m.

9. Kit according to any one of the preceding claims, wherein the collagen patch essentially has the form of a disc.

10. Kit according to claim 9, wherein the collagen disc has a diameter of 0.5-3 mm.

11. Kit according to any one of the preceding claims, wherein said adhesive composition further comprises factor XIII and thrombin.

12. Kit according to any one of the preceding claims, wherein the adhesive composition comprises said biocompatible polymer in an amount such that an aqueous solution formed from said composition has a viscosity of from 500 to 1 000 000 cP.

13. Kit according to any one of the preceding claims, wherein the biocompatible polymer capable of forming a viscous aqueous solution is a polysaccharide or proteoglycan which does not interfere with the fibrin clotting-process.

14. Kit according to claim 13, wherein the biocompatible polymer is selected from the group consisting of xanthan, dextran, cellulose and glycosaminoglycans, and salts and derivatives thereof.

15. Kit according to claim 14, wherein the biocompatible polymer is hyaluronic acid or a salt or derivative thereof.

16. Kit according to any one of the preceding claims for use in ophthalmic surgery.

17. Use of a kit according to claim 1 for the preparation of a sealing device for use in ophthalmic surgery to replace a natural lens which has been removed, in which sealing device the collagen patch of the kit is adapted to seal an opening in a capsular bag of an eye while admitting the entrance of an injection device through the opening for injection of a lens-forming material into the capsule;

and in which sealing device the adhesive composition of the kit is adapted to be applied to the collagen patch so as to enable adhesion of the collagen patch to the capsular bag.

18. Use according to claim 17, in which said kit is as defined in any one of claims 2-15.

19. Use according to any one of claims 17-18, in which the collagen patch is adapted to cover the entire opening.

20. Use according to any one of claims 17-19, in which the collagen patch is adapted to be placed inside of the capsular bag.

21. Use according to any one of claims 17-19, in which the collagen patch is adapted to be placed on the outside of the capsular bag.

22. Use according to any one of claims 17-21, in which the collagen patch is adapted to cover an opening of about 1 mm in diameter.

23. Use according to any one of claims 17-22, in which the opening is situated off the optical axis of the eye.

24. Use according to any one of claims 17-23, in which the collagen patch is thin enough to follow the accommodation movements of the capsular bag.

25. Use according to any one of claims 17-24, in which said collagen patch is provided with a removable adjusting means in the form of at least one flexible thread, said at least one thread being of such a length that it protrudes outside of the eye and can be manipulated from outside the eye when the collagen patch is positioned to seal the opening.

26. Use according to any one of claims 17-25, in which said sealing device is biodegradable, such that it is degraded within three weeks of being placed in or on a lens capsule.

27. Use according to claim 26, in which said sealing device is biodegradable, such that it is degraded within one week of being placed in or on a lens capsule.

28. Use according to any one of claims 26-27, in which said sealing device is biodegradable, such that it is degraded after completion of lens formation.

32. Method according to any one of claims 29-31, in which said collagen patch is as defined in any one of claims 2-10, 19-22 and 24-25.

33. Method according to any one of claims 29-32, in which said adhesive composition is as defined in any one of claims 11-15.

29. Method for sealing of an opening in a capsular bag of an eye in connection with ophthalmic surgery to replace a natural lens with a lens-forming composition, through injection thereof into the lens capsule through the opening, which method comprises:

introducing a collagen patch into the lens capsule through the opening, said collagen patch being adapted to seal the opening from the inside of the capsular bag;

adjusting the location of the collagen patch with an adjusting means operable from the outside of the capsular bag, so that the collagen patch at least partly covers the opening in the capsular bag;

displacing and/or deforming the collagen patch to admit passage into the capsular bag of the lens-forming composition;

repositioning the collagen patch so that it seals the opening in such a way that displacement of a lens-forming composition to the outside of the capsule is prevented;

applying an adhesive composition, comprising (i) fibrin, fibrinogen or a combination thereof and (ii) a biocompatible polymer capable of forming a viscous aqueous solution, to the collagen patch and/or the capsular bag to provide adhesion of the collagen patch to the capsular bag, thereby ensuring sealing of the opening.

30. Method for sealing of an opening in a capsular bag of an eye in connection with ophthalmic surgery to replace a natural lens with a lens-forming composition, through injection thereof into the lens capsule through the opening, which method comprises:

introducing a collagen patch into the lens capsule through the opening, said collagen patch being adapted to cover the opening from the inside of the capsular bag and to function as a septum for injection of a lens-forming composition therethrough;

adjusting the location of the collagen patch with an adjusting means operable from the outside of the capsular bag, so that the collagen patch covers the opening in the capsular bag;

applying an adhesive composition, comprising (i) fibrin, fibrinogen or a combination thereof and (ii) a biocompatible polymer capable of forming a viscous aqueous solution, to the collagen patch and/or the capsular bag to provide adhesion of the collagen patch to the capsular bag, thereby ensuring sealing of the opening.

31. Method for sealing of an opening in a capsular bag of an eye in connection with ophthalmic surgery, which method comprises:

covering the opening with a collagen patch, the collagen patch being applied from the outside of the capsular bag;

applying an adhesive composition, comprising (i) fibrin, fibrinogen or a combination thereof and (ii) a biocompatible polymer capable of forming a viscous aqueous solution, to the collagen patch and/or the capsular bag to provide adhesion of the collagen patch to the capsular bag, thereby ensuring sealing of the opening.