DEVICE FOR SOFT TISSUE REPAIR OR REPLACEMENT

• US 20100063599A1
• Filed: 09/05/2008
• Published: 03/11/2010
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Pegasus Biologics, Inc. (Baxter International Inc.)
• Inventors: Weinstein, Al, Brunelle, John
• Granted Patent: US 9,387,280 B2
• Time in Patent Office: Days
• US Class Current: 623/23.720
• 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 mechanical reinforcing component defining a length, a width, and a depth, wherein the width is at least about 1 millimeter along at least a portion of the length and the depth is less than the width, at least a portion of the mechanical reinforcing component defining a porosity; and

a cellular scaffold component attached to the mechanical reinforcing component.

2. The composite implantable tissue attachment device of claim 1, a portion of the mechanical reinforcing component defining 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 length of the mechanical reinforcing component defining the second width is a terminal portion of the device.

4. The composite implantable tissue attachment device of claim 3, further comprising a second terminal portion of the mechanical reinforcing component defining the second width.

5. The composite implantable tissue attachment device of claim 4, wherein the terminal portions of the mechanical reinforcing component define a round cross section.

6. 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.

7. The composite implantable tissue attachment device of claim 1, the mechanical reinforcing component comprising multiple lengths defining the width, wherein the multiple lengths defining the width are separated from one another by lengths of the device defining widths that are less than the first width.

8. The composite implantable tissue attachment device of claim 1, wherein the cellular scaffold is a collagen scaffold.

9. The composite implantable tissue attachment device of claim 8, wherein the scaffold comprises crosslinked collagen.

10. The composite implantable tissue attachment device of claim 9, wherein the crosslinked collagen scaffold is a non-glutaraldehyde processed collagen scaffold.

11. The composite implantable tissue attachment device of claim 9, wherein the scaffold comprises crosslinked reconstituted collagen.

12. The composite implantable tissue attachment device of claim 1, wherein the cellular scaffold comprises a hydrogel.

13. The composite implantable tissue attachment device of claim 1, wherein the cellular scaffold overlays the entire length of the mechanical reinforcing component.

14. The composite implantable tissue attachment device of claim 1, wherein the cellular scaffold overlays a portion of the length of the mechanical reinforcing component.

15. The composite implantable tissue attachment device of claim 1, wherein the mechanical reinforcing component comprises fibers.

16. The composite implantable tissue attachment device of claim 15, wherein the fibers of the mechanical reinforcing component are polymeric fibers.

17. The composite implantable tissue attachment device of claim 16, wherein the polymeric fibers comprise polyetheretherketone.

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

19. The composite implantable tissue attachment device of claim 15, wherein the fibers are monofilament fibers.

20. The composite implantable tissue attachment device of claim 15, wherein the fibers are multifilament fibers.

21. The composite implantable tissue attachment device of claim 15, the mechanical reinforcing component comprising a plurality of different fibers.

22. 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.

23. 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 width has an average pore size of less than about 100 micrometers.

24. The composite implantable tissue attachment device of claim 1, wherein the mechanical reinforcing component is woven.

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

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

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

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

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

30. A method for forming a composite implantable tissue attachment device comprising:

forming a mechanical reinforcing component by attaching a plurality of fibers to one another to form the component defining a length, width and a depth, wherein at least a portion of the length of the component defines a width of at least about 1 millimeter and the depth is less than the width, at least a portion of the mechanical reinforcing component defining a porosity; and

attaching a cellular scaffold to at least a portion of the mechanical reinforcing component.

31. The method according to claim 30, wherein the step of attaching the fibers to one another comprises weaving or knitting the fibers together.

32. The method according to claim 30, wherein the fibers are multifilament fibers.

33. The method according to claim 30, wherein the cellular scaffold is attached to at least a portion of the mechanical reinforcing component with suture.

34. The method according to claim 30, wherein the cellular scaffold is attached to a first side of the mechanical reinforcing component, the method further including attaching a second cellular scaffold to a second side of the mechanical reinforcing component.

35. The method according to claim 30, further comprising tapering the width to a second width that is less than the first width, such that a portion of the length of the device defines the second width.

36. The method according to claim 30, further comprising tapering the width to a second width at both ends of the portion of the device that defines the width such that two portions of the length of the device define the second width.

37. The method according to claim 30, further comprising sterilizing the device.

38. 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 mechanical reinforcing component defining a length, a width, and a depth, wherein the width is at least about 1 millimeter along at least a portion of the length and the depth is less than the width, the mechanical reinforcing component defining a tensile strength and porosity, the composite implantable tissue device also comprising a cellular scaffold component attached to the mechanical reinforcing component;

and

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

39. The method according to claim 38, wherein the first tissue and the second tissue are different tissues.

40. The method according to claim 38, wherein the first tissue and the second tissue are different areas of the same tissue.

41. The method according to claim 38, wherein at least one of the first tissue and the second tissue is a soft tissue.

42. The method according to claim 41, wherein the soft tissue is human soft tissue.

43. The method according to claim 38, wherein the first tissue is a ligament or a tendon.

44. The method according to claim 38, wherein the first tissue is bone.

45. The method according to claim 38, wherein the first tissue is cartilage.

46. The method according to claim 38, wherein the composite implantable tissue attachment device is attached to the second tissue such that the cellular scaffold is in contact with at least one of the first tissue and the second tissue.

47. A method according to claim 38, wherein the repair comprises restoring a soft tissue to bone insertion site.

48. A method according to claim 38, wherein the repair comprises increasing contact area between the first tissue and the second tissue.

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

50. A method according to claim 38, wherein the repair comprises the delivery of a cellular scaffold.

51. A method according to claim 38, wherein the cellular scaffold comprises collagen.

52. A method according to claim 38, wherein the repair comprises increasing vascularity.

53. A method according to claim 38, wherein the composite implantable tissue attachment device is utilized to deliver protein rich plasma.

54. A method according to claim 38, wherein the composite implantable tissue attachment device is utilized to deliver bone marrow aspirate.

55. A method according to claim 38, wherein the composite implantable tissue attachment device is utilized to deliver growth factors.