Synthetic structure for soft tissue repair

• US 9,597,430 B2
• Filed: 07/31/2009
• Issued: 03/21/2017
• Est. Priority Date: 07/31/2009
• Status: Active Grant

• Current Assignee: Synthasome, Inc.
• Original Assignee: Synthasome, Inc.
• Inventors: Ratcliffe, Anthony, Kern, Andreas, Sotoudeh, Mohammad, Ratcliffe, Fatemeh
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/533,473
• Publication Number:
  US 20110029078A1
• Time in Patent Office: 2,790 Days
• Field of Search: 623/11.11, 623/13.11, 623 1317- 1318
• US Class Current: 1/1
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Synthetic structures for soft tissue repair include a multi-layer planar fibrillar structure having layers which are intermittently secured to each other and which approximates mechanical properties comparable to those of soft tissue. In embodiments, the fibrillar structure possesses an intermittently secured edge portion secured by intermittent welds. In embodiments, the multi layer planar fibrillar structure includes a bioactive agent.

Claims

1. An implant comprising:

a multi-layer planar fibrillar structure wherein the layers of said fibrillar structure are intermittently secured to each other by a series of discrete points of attachment to provide a discontinuous length of attachment on at least one edge portion.

2. The implant of claim 1, wherein the multi-layer planar fibrillar structure approximates mechanical properties of soft tissue.

3. The implant of claim 2, wherein the multi-layer planar fibrillar structure is adapted to approximate the mechanical properties of soft tissue selected from the group consisting of a human tendon and a human ligament.

4. The implant of claim 3, wherein the multi-layer planar fibrillar structure exhibits a stiffness of from about 10 to about 500 Newtons per millimeter.

5. The implant of claim 3, wherein the multi-layer planar fibrillar structure exhibits a tensile strength of from about 20 to about 2000 Newtons.

6. The implant of claim 3, wherein the multi-layer planar fibrillar structure exhibits a failure strain at from about 105% to about 160% of its original length.

7. The implant of claim 2, wherein the multi-layer planar fibrillar structure exhibits a suture pullout strength of about 180 N per centimeter of multi-layer planar fibrillar structure width.

8. The implant of claim 1, wherein the multi-layer planar fibrillar structure comprises two layers.

9. The implant of claim 1, wherein said edge portion is intermittently secured by intermittent ultrasonic welds.

10. The implant of claim 1, wherein two opposing edge portions are intermittently secured.

11. The implant of claim 1, wherein the multi-layer planar implant further comprises two unsecured opposing edge portions.

12. The implant of claim 11, wherein two secured edge portions form a throughhole between the unsecured edge portions.

13. The implant of claim 1, wherein the multi-layer planar fibrillar structure is bioabsorbable.

14. The implant of claim 13, wherein the multi-layer planar fibrillar structure is fabricated from at least a member selected from the group consisting of glycolide, lactide, trimethylene carbonate, dioxanone, caprolactone, alkylene oxides, ortho esters, collagen, hyaluronic acids, alginates, and combinations thereof.

15. The implant of claim 1, wherein the multi-layer planar fibrillar structure is non-bioabsorbable.

16. The implant of claim 15 wherein the multi-layer planar fibrillar structure is fabricated from at least a member of the group consisting of polypropylene, polyethylene, polyamide, polyalkylene therephalate, polyvinylidene fluoride, polytetrafluoroethylene and combinations thereof.

17. The implant of claim 1, wherein at least one layer of the multi-layer planar fibrillar structure has from about 10 to about 200 warp fibers per inch.

18. The implant of claim 1, wherein at least one layer of the multi-layer planar fibrillar structure is knitted.

19. The implant of claim 1, wherein at least one layer of the multi-layer planar fibrillar structure is woven.

20. The implant of claim 1, wherein at least one layer of the multi-layer planar fibrillar structure is non-woven.

21. The implant of claim 1, wherein at least one layer of the multi-layer planar fibrillar structure is felt.

22. The implant of claim 1, wherein the multi-layer planar fibrillar structure comprises at least one fiber having a diameter from about 10 microns to about 200 microns.

23. The implant of claim 1, wherein the multi-layer planar fibrillar structure comprises at least two fibers of different diameters.

24. The implant of claim 1, wherein the planar fibrillar structure includes a bioactive agent.

25. The implant of claim 1, wherein the planar fibrillar structure includes a bioactive agent within at least one secured edge portion.

26. The implant of claim 1, further comprising a middle layer containing a bioactive agent.

27. The implant of claim 26, wherein the middle layer is intermittently secured between layers.

28. The implant of claim 26, wherein the middle layer is not secured.

29. The implant of claim 26, wherein the middle layer comprises a material selected from the group consisting of non-woven, woven, knit, hydrogel and combinations thereof.

30. The implant of claim 26, wherein the middle layer is felt.

31. The implant of claim 26, wherein the bioactive agent is selected from the group consisting of platelet-rich plasma, bone marrow, growth factor and combinations thereof.

32. The implant of claim 26 wherein the multi-layer planar fibrillar structure comprises a first woven layer;

a felt middle layer containing a bioactive agent; and

a second woven layer;

wherein said first woven layer and said second woven layer are intermittently secured on at least one edge portion.

33. The implant of claim 32, wherein the felt middle layer comprises a bioactive agent selected from the group consisting of platelet-rich plasma, bone marrow, growth factor, and combinations thereof.

34. The implant of claim 32 wherein the first woven layer, the felt middle layer and the second woven layer are intermittently secured to each other.

35. The implant of claim 1, wherein the discrete points of attachment are arranged linearly in one or more lines.

36. The implant of claim 1, wherein the discrete points of attachment are arranged in a staggered pattern.

37. An implant comprising:

a planar fibrillar structure comprising a first layer defining an upper surface of the planar fibrillar structure and a second layer defining a lower surface of the planar fibrillar structure;

a flexible edge portion including intermittent points of attachment of the first layer directly to the second layer to provide a discontinuous length of attachment of the first and second layers; and

an unsecured edge portion including a throughhole therebetween.

38. A mesh comprising fibrillar layers which are intermittently secured to each other on at least one edge portion to provide a discontinuous length of attachment of the fibrillar layers and form an unsecured edge portion.