Synthetic structure for soft tissue repair

• US 9,820,847 B2
• Filed: 08/17/2007
• Issued: 11/21/2017
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Synthasome, Inc.
• Original Assignee: Synthasome, Inc.
• Inventors: Ratcliffe, Anthony, Kern, Andreas
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US11/893,802
• Publication Number:
  US 20080051888A1
• Time in Patent Office: 3,749 Days
• Field of Search: 623 1311- 132, 623 1318, 623 2372- 2375
• 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 repair of a rotator cuff comprising a polymeric fibrillar structure having a length and a width and having uniform fibrillar distribution, a stiffness of about 10 to about 500 Newtons per millimeter (N/mm) along the length and along the width, and at least one fiber having a diameter ranging from about 10 microns to about 200 microns, wherein the fibrillar structure is a planar woven structure, the planar woven structure exhibiting mechanical properties of human rotator cuff tendon.

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

3. The synthetic structure of claim 2, wherein the polymeric 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, polymers and copolymers thereof, collagen, hyaluronic acids, alginates, and combinations thereof.

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

5. The synthetic structure of claim 4, wherein the polymeric fibrillar structure is fabricated from at least a member of the group consisting of polypropylene, polyethylene, polyamide, polyalkylene terephthalate, polyvinylidene fluoride, polytetrafluoroethylene and blends and copolymers thereof.

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

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

8. The synthetic structure of claim 1, wherein the polymeric fibrillar structure exhibits a tensile strength of at least about 220 Newtons.

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

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

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

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

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

14. 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.

15. 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.

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

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

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

19. The synthetic structure of claim 18 wherein the bioactive agent is selected from the group consisting of extracellular matrix molecules, growth factors and hyaluronic acid.

20. A synthetic structure for repair of a rotator cuff comprising a polymeric fibrillar structure, wherein the fibrillar structure comprises two planar woven layers having the same mechanical properties, the fibrillar structure exhibiting a stiffness of about 10 to about 500 Newtons per millimeter (N/mm), a tensile strength of about 20 to about 2000 Newtons and a failure strain at 105% to about 150% of original length.

21. A synthetic structure comprising:

a rectangular, bioabsorbable polymeric fibrillar structure configured for human rotator cuff tendon repair and having two planar woven layers, each of the two planar woven layers having the same mechanical properties and a uniform fibrillar distribution.