Implantable graft material

• US 7,815,923 B2
• Filed: 12/26/2006
• Issued: 10/19/2010
• Est. Priority Date: 12/29/2005
• Status: Expired due to Fees

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Hiles, Michael C., Johnson, Chad E.
• Primary Examiner(s): Davis; Ruth A
• Application Number:
  US11/616,159
• Publication Number:
  US 20070154515A1
• Time in Patent Office: 1,393 Days
• Field of Search: 424/400, 424/422
• US Class Current: 424/400
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/3603 implanted without ablation of the whole natural femoral head endoprosthetic cartilage A61F2/30756
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30245 Partial spheres
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30649 Ball-and-socket joints
• CPC Class Codes: A61F 2002/30754 Implants for interposition between two natural articular surfaces
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4007 : implanted without ablation of the whole natural humeral head
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 : Connective tissue
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3804 : characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3843 : Connective tissue
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof

Abstract

Described are graft materials suitable for implantation within a patient including isolated tissue material remodeled in a body cavity. Also described are methods of treating a patient that include implanting these materials and prosthetic devices comprising these materials within the patient'"'"'s body.

Claims

1. An isolated graft material retaining a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, said isolated graft material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said graft material to retain said valve cusp shape.

2. The isolated graft material of claim 1, wherein said remodelable extracellular matrix material retains bioactive components native to a source tissue for the extracellular matrix material.

3. The isolated graft material of claim 2, wherein said remodelable extracellular matrix material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

4. The isolated graft material of claim 2, wherein the bioactive components comprise growth factors.

5. The isolated graft material of claim 1, wherein said remodelable extracellular matrix material includes a section that is held in tension against a surface of said implanted shaping element in said body cavity.

6. The isolated graft material of claim 1 coupled to an implantable valve frame.

7. The isolated graft material of claim 1 further providing a generally hollow, tubular graft which incorporates said valve cusp within said tubular graft.

8. The isolated graft material of claim 1, wherein said remodelable extracellular matrix material is further associated with a frame element in said body cavity.

9. A method of forming an isolated graft material suitable for implantation in the body of a patient, the method comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

10. The method of claim 9, wherein the tissue material is removed from the body cavity at least 15 days after being inserted therein.

11. The method of claim 9, wherein the tissue material is removed from the body cavity no later than 45 days after being inserted therein.

12. The method of claim 9, wherein the tissue material is removed from the body cavity at least 25 days after being inserted therein.

13. The method of claim 9, wherein said remodelable extracellular matrix material retains bioactive components native to a source tissue for the extracellular matrix material.

14. The method of claim 13, wherein said remodelable extracellular matrix material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

15. A method of forming an isolated, decellularized tissue material, the method comprising:

removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue; and

decellularizing the tissue material following removal from said body cavity.

16. The method of claim 15, wherein said tissue material is in the form of a sheet.

17. The method of claim 15, wherein said tissue material is in the form of a tube.

18. The method of claim 17, wherein said tube is hollow.

19. The method of claim 15, wherein said tissue material provides one or more valve leaflets.

20. The method of claim 15, wherein said tissue material is in the form of a prosthetic ligament or tendon.

21. The method of claim 15, wherein said remodelable extracellular matrix material was seeded with one or more cell populations prior to being inserted in said body cavity.

22. The method of claim 15, wherein said remodelable extracellular matrix material is associated with a frame element in said body cavity.

23. The method of claim 22, wherein said frame element comprises one or more stents.

24. The method of claim 23, wherein said one or more stents includes a plurality of discrete, spaced stents which are embedded within and interconnected to one another by said tissue material.

25. The method of claim 15, wherein said isolated, decellularized tissue material is adapted for implantation in a joint.

26. The method of claim 15, wherein said body cavity is that of a vertebrate.

27. The method of claim 26, wherein said body cavity is that of a bovine, equine, ovine, or porcine.

28. The method of claim 26, wherein said body cavity is that of a human.

29. The method of claim 15, wherein said body cavity is a peritoneal cavity.

30. The method of claim 15, wherein said body cavity is a thoracic cavity, scrotum, brain, joint, or pericardial cavity.

31. The method of claim 15, wherein said remodelable extracellular matrix material is associated with an implanted shaping element in the body cavity.

32. The method of claim 31, wherein said implanted shaping element is biodegradable.

33. The method of claim 31 further comprising separating said shaping element from said graft material after said graft material is removed from said body cavity.

34. The method of claim 31, wherein said isolated, decellularized tissue material retains a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway.

35. The method of claim 15, wherein said remodelable extracellular matrix material is located inside a shaping mold in said body cavity.

36. The graft material of claim 35, wherein a wall of said shaping mold is perforated to allow fluid access through said wall.

37. The method of claim 35, wherein said shaping mold comprises a hollow tubular mold.

38. The method of claim 37, wherein said remodelable extracellular matrix material is received within and fills said hollow tubular mold.

39. The method of claim 15, wherein said isolated, decellularized graft material provides an elongate graft body having a generally solid cross section for providing a prosthetic ligament or tendon.

40. The method of claim 15, wherein said remodelable extracellular matrix material comprises a sheet of remodelable extracellular matrix material obtained in sheet form from a collagenous tissue source.

41. The method of claim 40, wherein said remodelable extracellular matrix sheet material retains bioactive components native to a source tissue for the extracellular matrix sheet material.

42. The method of claim 41, wherein said remodelable extracellular matrix sheet material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

43. The method of claim 40, wherein said remodelable extracellular matrix sheet material includes a section that is held in tension against a surface of an implanted shaping element in said body cavity.

44. The method of claim 43, wherein said surface is generally cylindrical.

45. The method of claim 43, wherein said surface is generally planar.

46. The method of claim 43, wherein said section, when held in tension against said surface of said implanted shaping element, takes the shape of a valve cusp.

47. The method of claim 46, wherein said valve cusp shape is maintained during remodeling of the remodelable extracellular matrix material such that said valve cusp shape is generally retained by said section after removal from the body cavity.

48. An isolated tissue material suitable for implantation in the body of a patient, said isolated tissue material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

49. The isolated tissue material of claim 48, wherein said remodelable extracellular matrix material comprises serosa, pericardium, submucosa, dura mater, peritoneum, or dermal collagen.

50. The isolated tissue material of claim 48, wherein said tissue material comprises said remodelable extracellular matrix material remodeled in said body cavity.

51. The isolated tissue material of claim 48 further comprising mesothelial cells from said body cavity.

52. The isolated tissue material of claim 48 further comprising myofibroblasts from said body cavity.

53. The isolated tissue material of claim 48 provided in a decellularized state.