Composite Implant for Surgical Repair

• US 20090018655A1
• Filed: 07/13/2007
• Published: 01/15/2009
• Est. Priority Date: 07/13/2007
• Status: Abandoned Application

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Inventors: Siegel, Joshua, Brunelle, John, Yantzer, Brenda, Nguyen, Christine, Sander, Thomas
• Application Number:
  US11/777,733
• Publication Number:
  US 20090018655A1
• Time in Patent Office: Days
• US Class Current: 623/13.190
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/1128 of nerves
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• 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
• CPC Class Codes: A61L 27/24 Collagen

Abstract

Disclosed are biocompatible implants that combine a scaffold material for supporting long term repair of a soft tissue with an elongated member such as a suture for aiding in placement of the scaffold during a surgical procedure as well as for immediate mechanical reinforcement of a repair site. The components of an implant are combined such that a longitudinal load placed upon a composite structure can be borne primarily by the elongated member and the scaffold material is isolated from the longitudinal load. Thus, the scaffold material of a composite can be protected from damage due to applied loads and stresses during and following a surgical procedure.

Claims

1. A biocompatible implant comprising:

a scaffold that allows cellular ingrowth thereto; and

an elongated member affixed to the scaffold;

wherein

the scaffold and the elongated member are held in contact with one another along a length of the scaffold and the elongated member extends from a surface of the scaffold.

2. The biocompatible implant of claim 1, wherein the elongated member has a tensile strength greater than that of the scaffold.

3. The biocompatible implant of claim 1, wherein a longitudinal load placed upon the implant along the axis of the elongated member is primarily borne by the elongated member.

4. The biocompatible implant of claim 1, wherein the scaffold comprises collagen.

5. The biocompatible implant of claim 4, wherein the scaffold comprises crosslinked collagen.

6. The biocompatible implant of claim 5, wherein the crosslinked collagen-containing scaffold is a non-glutaraldehyde processed collagen-containing scaffold.

7. The biocompatible implant of claim 4, wherein the scaffold comprises crosslinked reconstituted collagen.

8. The biocompatible implant of claim 1, wherein the elongated member is suture.

9. The biocompatible implant of claim 1, wherein the biocompatible implant comprises two or more scaffolds.

10. The biocompatible implant of claim 9, wherein the two or more scaffolds are twisted or braided together.

11. The biocompatible implant of claim 1, wherein the biocompatible implant comprises a plurality of elongated members.

12. The biocompatible implant of claim 1, wherein the elongated member is derived from a natural tissue.

13. The biocompatible implant of claim 1, wherein the elongated member comprises a woven fabric.

14. The biocompatible implant of claim 13, wherein the woven fabric covers the entire surface area of the scaffold.

15. The biocompatible implant of claim 1, wherein the implant has an aspect ratio of about 1.

16. The biocompatible implant of claim 1, wherein the elongated member is non-pliable.

17. The biocompatible implant of claim 1, wherein the elongated member is woven through the scaffold.

18. The biocompatible implant of claim 1, wherein the elongated member is stitched to the scaffold.

19. The biocompatible implant of claim 18, the stitching comprising a locking stitch.

20. The biocompatible implant of claim 1, wherein the implant is sterile.

21. The biocompatible implant of claim 1, further comprising a reinforcement material covering at least a portion of the surface area of the scaffold.

22. The biocompatible implant of claim 21, wherein the reinforcement material comprises a fabric.

23. The biocompatible implant of claim 1, further comprising a biologically active agent incorporated in or on the implant.

24. A method of forming a biocompatible implant comprising:

applying an elongated member to a scaffold that allows cellular ingrowth thereto such that the elongated member and the scaffold are held in contact along a length of the scaffold; and

affixing the elongated member to the scaffold such that at least one portion of the elongated member extends from the scaffold.

25. The method according to claim 24, wherein the step of affixing the elongated member to the scaffold comprises weaving the elongated member through the scaffold.

26. The method according to claim 24, wherein the step of affixing the elongated member to the scaffold comprises stitching the elongated member to the scaffold.

27. The method according to claim 26, wherein the stitching comprises forming a locking stitch.

28. The method according to claim 24, wherein the elongated member is affixed to the scaffold by use of a bioadhesive.

29. The method according to claim 24, further comprising braiding or twisting a plurality of scaffold to one another.

30. The method according to claim 24, the method further comprising forming the scaffold to a desired shape.

31. The method according to claim 24, the method further comprising forming a plurality of fenestrations or perforations in the scaffold at predetermined positions.

32. The method according to claim 24, wherein the elongated member is a length of suture.

33. The method according to claim 24, the method further comprising affixing a reinforcement material to at least a portion of the scaffold.

34. The method according to claim 33, wherein the reinforcement material is stitched to the scaffold.

35. A method of delivering a biocompatible implant to a tissue comprising

applying a longitudinal force to an elongated member of an implant to manipulate the implant, the implant comprising the elongated member affixed to a scaffold that allows cellular ingrowth thereto, the scaffold and the elongated member being held in contact with one another along a length of the scaffold, the longitudinal force being applied to a portion of the elongated member that extends beyond a surface of the scaffold;

and

attaching the biological implant to surrounding tissue.

36. The method of claim 35, wherein the scaffold is mechanically isolated from the longitudinal force applied to the elongated member.

37. The method of claim 35, wherein the elongated member is a suture.

38. The method of claim 35, wherein the tissue is soft tissue.

39. The method of claim 38, wherein the soft tissue is a ligament.

40. The method of claim 38, wherein the soft tissue is a tendon.

41. The method of claim 35, wherein the tissue is human soft tissue.