Device for soft tissue repair or replacement

• US 9,387,280 B2
• Filed: 09/05/2008
• Issued: 07/12/2016
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Synovis Orthopedic and Woundcare Incorporated (Baxter International Inc.)
• Inventors: Brunelle, John, Weinstein, Al
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US12/205,260
• Publication Number:
  US 20100063599A1
• Time in Patent Office: 2,867 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Disclosed are composite implantable tissue attachment devices comprising a mechanical reinforcing component and a cellular scaffold component. Disclosed devices include a wide, relatively flat portion for supporting long term repair of tissue. Disclosed devices can include a tapered portion at the end of the wide portions that can lead into a narrower elongated extension for aiding in placement of the device during a surgical procedure. The wide portion of the device can provide tensile strength along the longitudinal axis of the device as well as porosity. The wide devices can cover a larger surface area of a delivery site than standard suture. Disclosed materials can be utilized in, e.g., soft tissue repair such as tendon and ligament reconstruction and repair.

Claims

1. A composite implantable tissue attachment device comprising:

a) a mechanical reinforcing component made of woven fibers, consisting of;

i. a central portion defining a length, a first width, and a depth, wherein the first width is at least about 1 millimeter along at least a portion of the length and the depth is less than the first width, at least a portion of the central portion defining a porosity; and

ii. a single first terminal portion and a single second terminal portion; and

b) a first planar cellular scaffold component that overlays the central portion but not the first and second terminal portions of the mechanical reinforcing component; and

c) a second planar cellular scaffold component that overlays the central portion but not the first and second terminal portions of the mechanical reinforcing component;

wherein the first and second cellular scaffold components are shaped to match the shape of the central portion of the mechanical reinforcing component, the first and second cellular scaffold components are secured to a portion of a periphery of the reinforcing component by stitching such that the portion of periphery of the reinforcing component is stitched to a periphery of the first and second cellular scaffold components and the first and second cellular scaffold components are discrete and layered directly upon opposite sites of the mechanical reinforcing component.

2. The composite implantable tissue attachment device of claim 1, wherein the first terminal portion of the mechanical reinforcing component defines a second width, wherein the second width is less than the first width.

3. The composite implantable tissue attachment device of claim 2, wherein the first width of the mechanical reinforcing component tapers in transition to the second width.

4. The composite implantable tissue attachment device of claim 1, wherein the second terminal portion of the mechanical reinforcing component defines a second width that is less than the first width.

5. The composite implantable tissue attachment device of claim 1, wherein the first and second terminal portions of the mechanical reinforcing component define a round cross section.

6. The composite implantable tissue attachment device of claim 1, wherein the mechanical reinforcing component comprises multiple lengths of said central portion, wherein the multiple lengths are separated from one another by lengths of a neck.

7. The composite implantable tissue attachment device of claim 1, wherein the first and second cellular scaffold components are collagen scaffolds.

8. The composite implantable tissue attachment device of claim 7, wherein the collagen scaffolds comprise crosslinked collagen.

9. The composite implantable tissue attachment device of claim 8, wherein the crosslinked collagen scaffolds are non-glutaraldehyde processed collagen scaffolds.

10. The composite implantable tissue attachment device of claim 8, wherein the collagen scaffolds comprise crosslinked reconstituted collagen.

11. The composite implantable tissue attachment device of claim 1, wherein the first and second cellular scaffold components comprise a hydrogel.

12. The composite implantable tissue attachment device of claim 1, wherein the first and second cellular scaffold components overlay the entire length of the central portion of the mechanical reinforcing component.

13. The composite implantable tissue attachment device of claim 1, wherein the first and second cellular scaffold components overlay a portion of the length of the central portion of the mechanical reinforcing component.

14. The composite implantable tissue attachment device of claim 1, wherein the fibers of the mechanical reinforcing component are polymeric fibers.

15. The composite implantable tissue attachment device of claim 14, wherein the polymeric fibers comprise polyetheretherketone.

16. The composite implantable tissue attachment device of claim 14, wherein the polymeric fibers comprise an absorbable polymer.

17. The composite implantable tissue attachment device of claim 1, wherein the fibers are monofilament fibers.

18. The composite implantable tissue attachment device of claim 1, wherein the fibers are multifilament fibers.

19. The composite implantable tissue attachment device of claim 1, the mechanical reinforcing component comprising a plurality of different fibers.

20. The composite implantable tissue attachment device of claim 1, at least a portion of the mechanical reinforcing component defining a porosity less than about 1000 micrometers.

21. The composite implantable tissue attachment device of claim 1, wherein the at least a portion of the length of the mechanical reinforcing component defining the first width has an average pore size of less than about 100 micrometers.

22. The composite implantable tissue attachment device of claim 1, wherein the mechanical reinforcing component is a knit.

23. The composite implantable tissue attachment device of claim 1, wherein the mechanical reinforcing component comprises a braided component.

24. The composite implantable tissue attachment device of claim 1, where the tensile strength of said composite implantable tissue attachment device is greater than about 20 N.

25. The composite implantable tissue attachment device of claim 1, where the tensile strength of said composite implantable tissue attachment device is between about 100 N and about 5000 N.

26. The composite implantable tissue attachment device of claim 1, wherein the device is sterile.

27. A method of repairing a tissue comprising:

passing a first length of a composite implantable tissue attachment device through a first tissue, the composite implantable tissue device comprising;

a) a mechanical reinforcing component made of woven fibers, consisting of;

i. a central portion defining a length, a first width, and a depth, wherein the first width is at least about 1 millimeter along at least a portion of the length and the depth is less than the first width, at least a portion of the central portion defining a porosity; and

ii, a single first terminal portion and a single second terminal portion; and

b) a first planar cellular scaffold component that overlays the central portion but not the first and second terminal portions of the mechanical reinforcing component, and

c) a second planar cellular scaffold component that overlays the central portion but not the first and second terminal portions of the mechanical reinforcing component;

wherein the first and second cellular scaffolds components are shaped to match the shape of the central portion of the mechanical reinforcing component, the first and second cellular scaffold components are secured to a portion of a periphery of the reinforcing component by stitching such that the portion of the periphery of the reinforcing component is stitched to a periphery of the first and second cellular scaffold components and the first and second cellular scaffold components are discrete and layered directly upon opposite sites of the mechanical reinforcing component; and

attaching the composite implantable tissue attachment device to a second tissue.

28. The method according to claim 27, wherein the first tissue and the second tissue are different tissues.

29. The method according to claim 27, wherein the first tissue and the second tissue are different areas of the same tissue.

30. The method according to claim 27, wherein at least one of the first tissue and the second tissue is a soft tissue.

31. The method according to claim 30, wherein the soft tissue is human soft tissue.

32. The method according to claim 27, wherein the first tissue is a ligament or a tendon.

33. The method according to claim 27, wherein the first tissue is bone.

34. The method according to claim 27, wherein the first tissue is cartilage.

35. The method according to claim 27, wherein the composite implantable tissue attachment device is attached to the second tissue such that the first or second cellular scaffold component is in contact with at least one of the first tissue and the second tissue.

37. A method according to claim 27, wherein the repair comprises increasing contact area between the first tissue and the second tissue.

38. A method according to claim 27, wherein the repair comprises increasing pressure between the first tissue and the second tissue.

39. A method according to claim 27, wherein the repair comprises the delivery of a cellular scaffold.

40. A method according to claim 27, wherein the cellular scaffold comprises collagen.

41. A method according to claim 27, wherein the repair comprises increasing vascularity.

42. A method according to claim 27, wherein the composite implantable tissue attachment device is utilized to deliver at least one of protein rich plasma, bone marrow aspirate and growth factors.

36. A method according to claim caini 27, wherein the repair comprises restoring a soft tissue to bone insertion site.