Synthetic structure for soft tissue repair

• US 20080051888A1
• Filed: 08/17/2007
• Published: 02/28/2008
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Synthasome, Inc.
• Original Assignee: Synthasome, Inc.
• Inventors: Ratcliffe, Anthony, Kern, Andreas
• Granted Patent: US 9,820,847 B2
• Time in Patent Office: Days
• US Class Current: 623/13.18
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Synthetic structures for fibrous soft tissue repair include a polymeric fibrillar structure that exhibits mechanical properties of the human fibrous soft tissue.

Claims

1. ) A synthetic structure for human soft fibrous tissue support and/or repair comprising a polymeric fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of the human fibrous soft tissue.

2. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits mechanical properties of human tendon or ligament.

3. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure is bioabsorbable.

4. ) The synthetic structure of claim 3, wherein the polymeric fibrillar structure is fabricated from at least a member selected from the group consisting of glycolide, lactide, trimethylene carbonate, dioxanone, caprolactone, alklene oxides, ortho esters, polymers and copolymers thereof, collagen, hyaluronic acids, alginates, and combinations thereof.

5. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure is non-bioabsorbable.

6. ) The synthetic structure of claim 5, wherein the polymeric fibrillar structure is fabricated from at least a member of the group consisting of polypropylene, polyethylene, polyamide, polyalkylene therephalate, polyvinylidene fluoride, polytetrafluoroethylene and blends and copolymers thereof.

7. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits the mechanical properties of a human tendon.

8. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits a stiffness of about 10 to about 500 Newtons per millimeter (N/mm).

9. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits a tensile strength of about 20 to about 2000 Newtons.

10. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits a failure strain at 105% to about 150% of original length.

11. ) The synthetic structure of claim 1 wherein the polymeric fibrillar structure exhibits mechanical properties of a human ligament.

15. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure has about 10 to about 150 warp fibers per inch.

16. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure has about 30 to about 100 warp fibers per inch.

17. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure has about 50 to about 75 warp fibers per inch.

18. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure is knitted.

19. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure is woven.

20. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure is non-woven.

21. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure comprises at least one fiber having a diameter ranging from about 10 microns to about 200 microns.

22. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure comprises at least one fiber having a diameter ranging from about 30 microns to about 100 microns.

23. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure comprises at least one fiber having a diameter ranging from about 50 microns to about 80 microns.

24. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure comprises at least two fibers of different diameters.

25. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure has at least two layers.

26. ) The synthetic structure of claim 1, wherein the polymeric fibrillar structure includes a bioactive agent thereon.

27. ) The synthetic structure of claim 26 wherein the bioactive agent is selected from the group consisting of extracellular matrix molecules, growth factors and hyaluronic acid.

12. ) The synthetic structure of claim 12, wherein the polymeric fibrillar structure exhibits a stiffness of about 10 to about 500 Newtons per millimeter (N/mm).

13. ) The synthetic structure of claim 12, wherein the polymeric fibrillar structure exhibits a tensile strength of about 20 to about 2000 Newtons.

14. ) The synthetic structure of claim 12, wherein the polymeric fibrous structure exhibits a failure strain at 105% to about 150% of original length.

28. ) A method of providing functional support for a human tendon comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of a human tendon; and

affixing the fibrillar structure to the human tendon or fragments thereof.

29. ) A method of replacing the function of a human tendon comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of a human tendon; and

affixing the fibrillar structure to a member of the group selected from the group consisting of muscle, bone, ligament, tendon, and fragments thereof.

30. ) A method of providing functional support for a human ligament comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of a human ligament; and

affixing the fibrillar structure to the human ligament or fragments thereof.

31. ) A method of replacing the function of a human ligament comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of a human ligament; and

affixing the fibrillar structure to a member of the group selected from the group consisting of muscle, bone, ligament, tendon, and fragments thereof.

32. ) A method of providing functional support for a human tendon comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits mechanical properties of a human tendon in combination with a member selected from the group consisting of;

small intestine submucosa (SIS) biologic graft materials;

acellular dermal tissue matrices; and

cross-linked pericardium xenografts that has been subjected to an anticalcification process; and

affixing the combination to the human tendon or fragments thereof.

33. ) A method of providing functional support for a human ligament comprising:

providing a fibrillar structure, wherein the fibrillar structure exhibits

mechanical properties of a human ligament in combination with a member selected from the group consisting of;

small intestine submucosa (SIS) biologic graft materials;

acellular dermal tissue matrices; and

cross-linked pericardium xenografts that has been subjected to an anticalcification process; and

affixing the combination to the human ligament or fragments thereof.