IMPLANTABLE GRAFT MATERIAL

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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 provides a flow chart depicting one embodiment of the present invention for treating a patient.

FIG. 2A provides a perspective view of one prosthesis-forming device of the present invention.

FIG. 2B provides a front view of the device of FIG. 2A along the view line 2-2 shown in FIG. 2A.

FIG. 3A provides a perspective view of another prosthesis-forming device of the present invention.

FIG. 3B provides a front view of the device of FIG. 3A along the view line 3-3 shown in FIG. 3A.

FIG. 4A provides a perspective view of a graft-forming device of the present invention.

FIG. 4B provides a front view of the device of FIG. 4A along the view line 4-4 shown in FIG. 4A.

FIG. 5A provides a perspective view of one prosthetic valve of the present invention.

FIG. 5B provides a perspective view of the valve of FIG. 5A implanted within a body passageway, the valve in a generally open configuration.

FIG. 5C provides a perspective view of the valve of FIG. 5A implanted within a body passageway, the valve in a generally closed configuration.

FIG. 6A provides a perspective view of another prosthesis-forming device of the present invention.

FIG. 6B provides a front view of the device of FIG. 6A along the view line 6-6 shown in FIG. 6A.

FIG. 7A provides a perspective view of another prosthesis-forming device of the present invention.

FIG. 7B provides a front view of the device of FIG. 7A along the view line 7-7 shown in FIG. 7A.

FIG. 8 provides a top view of a medical product of the present invention.

FIG. 9 provides a perspective view of a graft device of the invention.

FIG. 10 provides a partial cut-away perspective view of another graft device of the invention.

Claims

1. A graft material suitable for implantation comprising an isolated tissue material remodeled in a body cavity.

2. The graft material of claim 1, wherein said isolated tissue material comprises mesothelial cells.

3. The graft material of claim 1, wherein said isolated tissue material comprises myofibroblasts.

4. The graft material of claim 1 in a decellularized state.

5. The graft material of claim 1 adapted for implantation within the vascular system.

6. The graft material of claim 1 adapted for implantation within the venous system.

7. The graft material of claim 1 in sheet form.

8. The graft material of claim 1 in tubular form.

9. The graft material of claim 1 adapted to provide a hollow tube.

10. The graft material of claim 1 configured as one or more valve leaflets.

11. The graft material of claim 10 in combination with a frame element.

12. The graft material of claim 11, wherein said frame element is biodegradable.

13. The graft material of claim 1 adapted to augment or restore soft tissue.

14. The graft material of claim 1 adapted to provide a prosthetic ligament.

15. The graft material of claim 1, further comprising cells seeded on the isolated tissue material.

16. The graft material of claim 15, wherein the cells include at least one of endothelial cells, muscle cells and fibroblast cells.

17. An isolated graft material suitable for implantation, said material prepared by a process comprising removing from a body cavity of a host a previously inserted amount of remodelable material.

18. The graft material of claim 17, wherein said remodelable material comprises a collagenous material.

19. The graft material of claim 17, wherein said remodelable material comprises a remodelable extracellular matrix material.

20. The graft material of claim 19, wherein said remodelable extracellular matrix material comprises submucosa.

21. The graft material of claim 19, wherein said remodelable extracellular matrix material comprises porcine submucosa.

22. The graft material of claim 21, wherein said porcine submucosa comprises small intestine submucosa, urinary bladder submucosa, or stomach submucosa.

23. The graft material of claim 17 in a substantially sterile condition.

24. The graft material of claim 17, wherein said process further comprises adding one or more cell populations to said amount remodelable material before inserting the remodelable material into the body cavity.

25. The graft device of claim 17, wherein said amount of remodelable material comprises two or more layers of remodelable material.

26. The graft device of claim 25, wherein said two or more layers of remodelable material are bonded to one another.

27. A prosthetic device suitable for implantation, the device comprising isolated tissue material remodeled in a body cavity.

28. The device of claim 27, comprising a valve.

29. The device of claim 28, wherein said valve is configured as a vascular valve.

30. The device of claim 29, wherein said vascular valve is configured as a heart valve.

31. The device of claim 29, wherein said vascular valve is configured as a venous valve.

32. The device of claim 28, wherein said valve is frameless.

33. The device of claim 27, further comprising a stent.

34. The device of claim 33, wherein said stent is expandable.

35. The device of claim 33, wherein at least a portion of said stent is embedded within said isolated tissue material.

36. The device of claim 27, further comprising a plurality of discrete, spaced stents, wherein said stents are interconnected to one another by said isolated tissue material.

37. The device of claim 27 adapted for implantation in a joint.

38. A medical product, comprising: an amount of graft material suitable for implantation, the graft material comprising an isolated tissue material remodeled in a body cavity; anda sealed package containing said amount of graft material.

39. A method of forming an isolated graft material suitable for implantation comprising removing from a body cavity a previously inserted amount of remodelable material.

40. The method of claim 39, wherein the amount of material is removed from the body cavity at least 15 days after being inserted therein.

41. The method of claim 39, wherein the amount of material is removed from the body cavity no later than 45 days after being inserted therein.

42. The method of claim 39, wherein the amount of material is removed from the body cavity at least 25 days after being inserted therein.

43. The method of claim 39, wherein the amount of material is removed from and/or inserted into the body cavity laparoscopically.

44. The method of claim 39, wherein said body cavity is that of a vertebrate.

45. The method of claim 39, wherein said body cavity is that of a bovine, equine, ovine, or porcine.

46. The method of claim 39, wherein said body cavity is that of a human.

47. The method of claim 39, wherein said body cavity is a peritoneal cavity.

48. The method of claim 39, wherein said body cavity is a thoracic cavity, scrotum, brain, joint, or pericardial cavity.

49. The method of claim 39, wherein said amount of remodelable material is associated with a shaping element in the body cavity.

50. The method of claim 49, wherein said shaping element is separated from said isolated graft material before the graft material is implanted in a patient.

51. The method of claim 39, wherein said amount of remodelable material is associated with one or more stents in the body cavity.

52. The method of claim 51, wherein said isolated graft material remains associated with said one or more stents for implantation in a patient.

53. A method of treatment comprising implanting a prosthetic device in a patient, the device comprising an isolated tissue material remodeled in a body cavity.

54. A prosthetic valve suitable for implantation, the valve comprising isolated tissue material remodeled in a body cavity.