Barrier layer for implantable tendons and ligaments

• US 4,894,063 A
• Filed: 05/24/1983
• Issued: 01/16/1990
• Est. Priority Date: 05/24/1983
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Nashef, Aws S.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/497,490
• Time in Patent Office: 2,429 Days
• Field of Search: 3/1, 3/1.4, 3/1.5, 3/1.9, 128/92 C, 128/334 R
• US Class Current: 623/13.17
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04

Abstract

Disclosed is a method of interfacing a ligament substitute within a channel of resected bone with a sleeve of soft biological tissue. The sleeve of tissue has overall external dimension sufficient to extend through at least a portion of the resected bone channel and internal dimensions sufficient to receive a ligament substitute therein.

Claims

1. A method of interfacing a tendon or ligament within a channel of resected bone, comprising:

inserting a substantially cylindrical sleeve having an outer surface of soft biological tissue through a channel of resected bone such that the biological tissue is in contact with said resected bone and a barrier is formed between said resected bone and a tendon or ligament inserted therethrough;

said sleeve having a first and second open end portion, a longitudinal passage extending between said first and second end portions, wherein said longitudinal passage has internal dimensions sufficient to receive a tendon or ligament therethrough, and overall external dimensions sufficient to extend through at least a portion of the resected bone channel.

2. The method of claim 1 wherein the sleeve is naturally occurring biological tissue fixed with glutaraldehyde.

3. The method of claim 2 wherein the biological tissue is epithelial or fibrous connective tissue.

4. The method of claim 2 wherein the biological tissue is selected from the group consisting of pericardial tissue, dura mater, fascialata, or amnion.

5. The method of claim 2 wherein the biological tissue is a vein or an artery.

6. The method of claim 2 wherein the tissue is substantially resistant to calcification.

7. The method of claim 6 wherein the sleeve is made of pericardial tissue sewn together in a tube-like structure having its fibrous surface on the exterior of the sleeve.

8. The method of claim 1 wherein the sleeve is inserted into the ends of said channel such that the interior surface of the resected bone at the external edge portion is covered by said sleeve.

9. The method of claim 1 wherein the sleeve has a length sufficient to cover the entire interior surface of the resected bone channel.

10. The method of claim 9 wherein the sleeve has a length sufficient to extend beyond the edge of said resected bone channel.

11. The method of claim 10 wherein the sleeve is naturally occurring biological tissue fixed with glutaraldehyde.

12. The method of claim 11 wherein the biological tissue is epithelial or fibrous connective tissue.

13. The method of claim 11 wherein the biological tissue is selected from the group consisting of pericardial tissue, dura mater, fascilialata, or amnion.

14. The method of claim 11 wherein the biological tissue is a vein or an artery.

15. The method of claim 11 wherein the biological tissue is substantially resistant to calcification.

16. The method of claim 15 wherein the sleeve is made of pericardial tissue sewn together in a tube-like structure having its fibrous surface on the exterior of the sleeve.

17. A substantially cylindrical sleeve of soft biological tissue having a first and second open end portion, a longitudinal passage extending between said first and second end portions, wherein said longitudinal passage has internal dimensions sufficient to receive a tendon or ligament there through, and a length sufficient both to cover the entire interior surface of a resected bone channel, and to extend beyond the edge of said resected bone channel, such that said sleeve can be inserted through a channel of resected bone in accordance with claim 10, wherein the first and second end portions of the sleeve are outwardly flared.

18. The sleeve of claim 17 wherein the tissue is naturally occurring biological tissue fixed with glutaraldehyde.

19. The sleeve of claim 18 wherein the biological tissue is epithelial or fibrous connective tissue.

20. The sleeve of claim 19 wherein the biological tissue is selected from the group consisting of pericardial tissue, dura mater, fascilialata, or amnion.

21. The sleeve of claim 19 wherein the biological tissue is a vein or an artery.

22. The sleeve of claim 19 wherein the biological tissue is substantially resistant to calcification.

23. The sleeve of claim 22 wherein the sleeve is made of pericardial tissue sewn together in a tube-like structure having its fibrous surface on the exterior of the sleeve.

24. A surgical implant kit having component parts capable of being assembled in the operating theatre for repairing or replacing tendons or ligaments, wherein said tendons or ligaments are in close proximity to resected bone, the kit comprising the combination of:

a prosthetic or naturally occurring tendon or ligament adapted to be affixed to the resected bone; and

a substantially cylindrical sleeve having an outer surface of soft biological tissue such that the biological tissue is in contact with said resected bone when implanted;

said sleeve having a first and second open end portion, a longitudinal passage extending between said first and second portions, wherein said longitudinal passage has internal dimensions sufficient to receive a tendon or ligament therethrough; and

external dimensions sufficient to extend through at least a portion of the resected bone channel;

such that said biological tissue provides a barrier to said tendon or ligament from irregular edges of said resected bone.

25. The surgical kit of claim 24 wherein the sleeve is naturally occuring biological tissue fixed with glutaraldehyde.

26. The surgical kit of claim 25 wherein the biological tissue is epithelial or fibrous connective tissue.

27. The surgical kit of claim 25 wherein the sleeve is made of pericardial tissue sewn together in a tube-like structure having its fibrous surface on the exterior surface of the sleeve.

28. The surgical kit of claim 24 wherein the biological tissue is substantially resistant to calcification.

29. The surgical kit of claim 24 wherein the naturally occurring tendon or ligament is fixed with glutaraldehyde.

30. The surgical kit of claim 24 wherein the tendon or ligament is a synthetic prosthesis.