Device for delivery of antifibrotic agents & method

• US 20090124955A1
• Filed: 11/24/2008
• Published: 05/14/2009
• Est. Priority Date: 05/25/2006
• Status: Active Grant

• Current Assignee: Elutimed, LLC
• Original Assignee: Ramesh S. Ayyala
• Inventors: Ayyala, Ramesh S.
• Granted Patent: US 8,337,447 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

An ophthalmological device comprises an implant member carrying an antifibrotic agent that is released slowly over a prolonged period when inserted into a wound in an eye produced by surgery. The member is placed in the vicinity of a wound created during the surgery to inhibit inflammatory cell proliferation, thereby preventing the growth of fibrous tissue after the eye surgery.

Claims

1. An ophthalmological device comprising a member carrying an antifibrotic agent, said antifibrotic agent being released slowly over a prolonged period when inserted into a wound in an eye produced by surgery.

2. The ophthalmological device of claim 1 where said prolonged period is in excess of 1 week.

3. The ophthalmological device of claim 1 where the member comprises a porous polymeric material.

4. The ophthalmological device of claim 3 where the porous polymeric material is P-HEMA.

5. The ophthalmological device of claim 1 where the member comprises a bio-degradable material.

6. The ophthalmological device of claim 5 where the bio-degradable material is selected from the group consisting of collagen, chitosan, polysaccharides, and proteins, polylactides and a polylactide and glycolic acid copolymer, polyanhydrides, and polyesters.

7. The ophthalmological device of claim 1 comprising a distribution plate including the porous polymeric member.

8. The ophthalmological device of claim 7 including a tube extending from the distribution plate and having a free end adapted to be inserted into the intraocular chamber of the eye.

9. The ophthalmological device of claim 1 comprising a pressure responsive valve including a tube extending from the valve and having a free end adapted to be inserted into the intraocular chamber of the eye.

10. The ophthalmological device of claim 1 comprising a stent configured to be inserted into the Schlemm'"'"'s canal of the eye.

11. The ophthalmological device of claim 1 where the antifibrotic agent is selected from the group consisting of Mitomycin-C, 5-Flurouracil, Rapamycin, a transforming growth factor (TGF) antibody, a form of corticosteroid, an immunesuppresive agent, and heparin.

12. The ophthalmological device of claim 11 where the transforming growth factor (TGF) antibody is selected from the group consisting of TGF-B2 monoclonal antibody, Interlukin 1 or 6 antibody, and a cytokine antibody.

13. The ophthalmological device of claim 11 where the form of corticosteroid is dexamethasone.

14. The ophthalmological device of claim 11 where the immunesuppresive agent is selected from the group consisting of cyclosporin and FK57.

15. An ophthalmological device comprising an implant member having a surface coated with an antifibrotic agent that is released slowly over a prolonged period in excess of 1 week when inserted into a wound in an eye produced by surgery.

16. The ophthalmological device of claim 15 comprising a distribution plate including the porous polymeric member.

17. The ophthalmological device of claim 16 including a tube extending from the distribution plate and having a free end adapted to be inserted into the intraocular chamber of the eye.

18. The ophthalmological device of claim 15 comprising a pressure responsive valve including a tube extending from the valve and having a free end adapted to be inserted into the intraocular chamber of the eye.

19. The ophthalmological device of claim 15 comprising a stent configured to be inserted into the Schlemm'"'"'s canal of the eye.

20. The ophthalmological device of claim 15 where the implant member comprises a P-HEMA matrix.

21. The ophthalmological device of claim 15 where the antifibrotic agent is released at a rate of substantially from 0.03 to 0.09 milligrams per hour.

22. The ophthalmological device of claim 15 where the implant member has a width substantially from 4 mm to 15 mm, a length substantially from 4 mm to 15 mm, and a thickness substantially from 0.25 mm to 0.50 mm.

23. A method of inhibiting inflammatory cell proliferation to prevent fibrous tissue formation and prevent growth of fibrous tissue after eye surgery comprising placing in the vicinity of a wound created during the surgery an implant member carrying an antifibrotic agent that releases into the wound slowly over a prolonged period in excess of a week.

24. The method of claim 23 where the antifibrotic agent is released at a rate of substantially from 0.03 to 0.09 milligrams per hour.

25. The method of claim 23 where the eye surgery comprises implanting an ophthalmological device into the eye that includes said member.

26. The method of claim 25 where the ophthalmological device includes a tube extending from the distribution plate that has a free end inserted into an intraocular chamber of the eye during surgery.

27. The method of claim 25 where the ophthalmological device comprises a pressure responsive valve including a tube extending from the valve and having a free end that is inserted into an intraocular chamber of the eye during surgery.

28. The method of claim 25 where the ophthalmological device comprises a stent configured to be inserted into the Schlemm'"'"'s canal of the eye.

29. The method of claim 25 where the eye surgery is a trabeculectomy.

30. The method of claim 23 where the member comprises a bio-degradable material.

31. The method of claim 30 where the bio-degradable material is selected from the group consisting of collagen, chitosan, polysaccharides, and proteins, polylactides and a polylactide and glycolic acid copolymer, polyanhydrides, and polyesters.

32. The method of claim 23 where the member is inserted locally in a limbal pocket of the eye to inhibit limbal scar tissue from obstructing the eye'"'"'s deep scleral pocket or canulostomy opening in deep sclerectomy/viscocanulostomy eye operations.

33. An ophthalmological device comprising a member carrying an antifibrotic agent, said antifibrotic agent being released slowly over a prolonged period in excess of one week when inserted into a wound in an eye produced by surgery, said member comprising a porous polymeric material containing said agent and releasing said agent at a rate of substantially from 0.03 to 0.09 milligrams per hour, said agent being present in a sufficient amount so said agent is released over a period of time in excess of one week

34. The ophthalmological device of claim 33 where the porous polymeric material is P-HEMA.

35. The ophthalmological device of claim 33 comprising a distribution plate including the porous polymeric member.

36. The ophthalmological device of claim 35 including a tube extending from the distribution plate and having a free end adapted to be inserted into the intraocular chamber of the eye.

37. The ophthalmological device of claim 33 comprising a pressure responsive valve including a tube extending from the valve and having a free end adapted to be inserted into the intraocular chamber of the eye.

38. The ophthalmological device of claim 33 comprising a stent configured to be inserted into the Schlemm'"'"'s canal of the eye.