MANUFACTURE OF AN ORGAN IMPLANT

• US 20100119696A1
• Filed: 11/17/2009
• Published: 05/13/2010
• Est. Priority Date: 06/30/2006
• Status: Abandoned Application

• Current Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Original Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Inventors: Yu, Dao-Yi, Trip, Roelof, Mufson, Daniel, Mantri, Surag, McCrea, James, Yang, Ying, Cringle, Stephen, Anderson, Cory, Nguyen, Hoang Van, Su, Er-Ning, Tan, Colin
• Application Number:
  US12/620,557
• Publication Number:
  US 20100119696A1
• Time in Patent Office: Days
• US Class Current: 427/2.250
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61L 31/045 Gelatin
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

Methods, system and apparatus for relieving pressure in an organ such as, but not limited to, the eye are disclosed. The method includes implanting a bioabsorbable channel into the selected area of the organ using a delivery apparatus.

Claims

1. A method, of making an ocular implantable drainage channel, comprising:

providing a gelatin solution with a viscosity of from approximately 200 cP to approximately 500 cP;

coating an outer surface of a support with gelatin from the gelatin solution, the outer surface having an outer diameter of from approximately 50 microns to approximately 250 microns;

curing the gelatin on the support for at least one hour;

treating the gelatin, after curing the gelatin, with a cross-linking agent;

curing the cross-linked gelatin; and

removing said cross-linked gelatin channel from the support after curing the cross-linked gelatin.

2. The method of claim 1, wherein the gelatin solution is maintained, during the coating, at a temperature of from approximately 40°

to approximately 60°

C.

3. The method of claim 1, wherein said gelatin solution comprises approximately 40%, by weight, of gelatin dissolved in water.

4. The method of claim 1, wherein said cylindrical support comprises a stainless steel wire coated with a biocompatible material.

5. The method of claim 1, wherein the coating comprises dipping said support into a bath comprising the gelatin solution.

6. The method of claim 1, wherein the coating comprises spraying a gelatin solution onto a rotating support.

7. The method of claim 1, wherein the gelatin solution viscosity is from approximately 260 cP to approximately 410 cP.

8. The method of claim 1, wherein the gelatin is cured for from approximately 10 hours to approximately 24 hours.

9. The method of claim 1, wherein the gelatin is cured at a temperature of approximately 20°

C. to approximately 25°

C. and at a relative humidity of from approximately 30% to approximately 40%.

10. The method of claim 1, wherein the cross-linking agent comprises a solution of glutaraldehyde.

11. The method of claim 10, wherein the treating comprises dipping the cured gelatin in a 25% glutaraldehyde solution.

12. The method of claim 11, wherein the glutaraldehyde solution has a pH of approximately 7.35-7.44.

13. The method of claim 11, wherein the cured gelatin is dipped in the glutaraldehyde solution for at least 4 hours.

14. The method of claim 11, wherein the cured gelatin is dipped in the glutaraldehyde solution for between approximately 10 hours and approximately 36 hours.

15. The method of claim 1, wherein the cross-linked gelatin is cured for approximately 48 hours to approximately 96 hours.

16. The method of claim 1, wherein said cross-linking agent comprises 1-ethyl-3-[e-(dimethylamino)propyl]carbodiimide.

17. A method, of making an ocular implantable drainage channel, comprising:

providing a gelatin solution with a viscosity of from approximately 200 cP to approximately 500 cP;

coating an outer surface of a support with gelatin from the gelatin solution, the outer surface having an outer diameter of from approximately 50 microns to approximately 250 microns;

curing the gelatin on the support for at least one hour;

cross-linking the cured gelatin on the support;

curing the cross-linked gelatin; and

removing said cross-linked gelatin channel from the support after curing the cross-linked gelatin.

18. The method of claim 17, wherein the gelatin solution is maintained, during the coating, at a temperature of from approximately 40°

to approximately 60°

C.

19. The method of claim 17, wherein said gelatin solution comprises approximately 40%, by weight, of gelatin dissolved in water.

20. The method of claim 17, wherein the coating comprises dipping said support into a bath comprising the gelatin solution.

21. The method of claim 17, wherein the coating comprises spraying a gelatin solution onto a rotating support.

22. The method of claim 17, wherein the gelatin solution viscosity is from approximately 260 cP to approximately 410 cP.

23. The method of claim 17, wherein the gelatin is cured at a temperature of approximately 20°

C. to approximately 25°

C. and at a relative humidity of from approximately 30% to approximately 40%.

24. The method of claim 17, wherein cross-linking the gelatin comprises dipping the cured gelatin in a cross-linking agent.

25. The method of claim 17, wherein the treating comprises dipping the cured gelatin in a 25% glutaraldehyde solution.

26. The method of claim 17, wherein cross-linking the gelatin comprises exposing the gelatin to radiation.

27. The method of claim 26, wherein the radiation is selected from the group consisting of gamma and electron beam radiation.

28. The method of claim 17, wherein the cross-linked gelatin is cured for approximately 48 hours to approximately 96 hours.

29. A method, of making an implantable drainage channel, comprising:

providing a gelatin solution having a ratio of solid gelatin to water of from approximately 10%-50% gelatin by weight to 50%-90% water by weight;

coating an outer surface of a support with gelatin from the gelatin solution, the outer surface having an outer diameter of from approximately 50 microns to approximately 250 microns;

curing the gelatin on the support for at least one hour; and

cross-linking the cured gelatin on the support.

30. The method of claim 29, wherein the gelatin solution comprises a viscosity of from approximately 200 cP to approximately 500 cP.

31. The method of claim 29, wherein the gelatin solution is maintained, during the coating, at a temperature of from approximately 40°

to approximately 60°

C.

32. The method of claim 29, wherein said gelatin solution comprises approximately 40%, by weight, of gelatin dissolved in water.

33. The method of claim 29, wherein the coating comprises dipping said support into a bath comprising the gelatin solution.

34. The method of claim 29, wherein the coating comprises spraying a gelatin solution onto a rotating support.

35. The method of claim 29, wherein the gelatin is cured at a temperature of approximately 20°

C. to approximately 25°

C. and at a relative humidity of from approximately 30% to approximately 40%.

36. The method of claim 29, wherein cross-linking the gelatin comprises dipping the cured gelatin in a cross-linking agent.

37. The method of claim 29, wherein cross-linking the gelatin comprises exposing the gelatin to radiation.