Methods for modifying vascular vessel walls

• US 7,905,826 B2
• Filed: 12/07/2005
• Issued: 03/15/2011
• Est. Priority Date: 11/03/2004
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Flagle, Jacob A., Hiles, Michael C., Case, Brian C., Patel, Umesh H., Obermiller, F. Joseph
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/295,866
• Publication Number:
  US 20070004961A1
• Time in Patent Office: 1,924 Days
• Field of Search: 600/29, 600 36- 37, 128897-899, 623/1.1, 623/1.24, 623/1.25, 623/1.27, 623/1.28, 623/1.38, 623 144- 154, 424/93.1, 424/93.7
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• 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 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60

Abstract

This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Claims

1. A method of treating a patient to modify a vascular vessel having a defect, the method comprising:

accessing a treatment site proximate to a defect in a vascular vessel; and

introducing a remodelable biomaterial into a vessel wall or externally of a vessel wall at the treatment site;

wherein the remodelable biomaterial is effective to shrink as a result of remodeling so as to reshape the vascular vessel.

2. The method of claim 1 wherein the defect is an aneurysm.

3. The method of claim 1 wherein said accessing comprises inserting a cannulated delivery device intra-lumenally through the vascular vessel.

4. The method of claim 1 wherein said remodelable biomaterial is angiogenic.

5. The method of claim 3 wherein said introducing comprises injecting the remodelable biomaterial through the cannulated delivery device into the vessel wall.

6. The method of claim 3 comprising extending the cannulated delivery device through the vessel wall adjacent the treatment site to deliver the remodelable biomaterial to an external surface of the vessel wall.

7. The method of claim 1 wherein said accessing comprises inserting a cannulated delivery device exo-lumenally to the treatment site.

8. The method of claim 7 comprising injecting the remodelable biomaterial through the cannulated delivery device into the vessel wall.

9. The method of claim 7 comprising delivering the remodelable biomaterial to an external surface of the vessel wall.

10. The method of claim 1 comprising injecting the remodelable biomaterial into two or more sites spaced circumferentially about the vascular vessel.

11. The method of claim 1 wherein said introducing comprises wrapping a sheet of the remodelable biomaterial in contact with the external connective tissue of the vascular vessel.

12. The method of claim 11 wherein the remodelable biomaterial is a laminate comprising two or more sheets of a collagenous material.

13. The method of claim 11 comprising attaching the sheet of remodelable biomaterial to itself to form a band about the external connective tissue of the vascular vessel.

14. The method of claim 1 wherein said introducing comprises delivering an effective amount of the remodelable biomaterial externally of the vascular vessel to reinforce the vascular vessel wall.

15. The method of claim 1 wherein the remodelable biomaterial is a laminate comprising two or more sheets of a collagenous material.

16. The method of claim 1 wherein the remodelable biomaterial comprises an extracellular matrix material.

17. The method of claim 1 wherein the remodelable biomaterial comprises submucosa tissue.

18. The method of claim 1 wherein the remodelable biomaterial comprises collagen.

19. The method of claim 17, wherein said submucosa is porcine, bovine, or ovine submucosa.

20. The method of claim 1 wherein the remodelable biomaterial comprises a bioactive substance.

21. The method of claim 1 wherein the remodelable biomaterial comprises a population of viable cells.

22. The method of claim 21 wherein the cells comprise autologous cells.

23. A method of treating a patient with a vascular defect, said method comprising:

introducing a delivery device through the patient'"'"'s vasculature to a treatment site proximate to the vascular defect; and

delivering a remodelable biomaterial into or externally of a wall of the vessel at the treatment site;

wherein the remodelable biomaterial is effective to shrink as a result of remodeling so as to reshape the vascular vessel.

24. The method of claim 23 wherein the defect is an aneurysm.

25. The method of claim 23 wherein the defect is a fistula.

26. The method of claim 23 wherein said introducing comprises introducing a delivery device through a vein.

27. The method of claim 23 wherein said introducing comprises introducing a delivery device through an artery.

28. The method of claim 23 wherein said introducing comprises injecting the remodelable biomaterial through the delivery device into the vessel wall.

29. The method of claim 23 comprising extending the delivery device through the vessel wall to deliver the remodelable biomaterial to an external surface of the vessel wall.

30. The method of claim 23 wherein said delivering comprises delivering an effective amount of the remodelable biomaterial externally of the vascular vessel to reinforce the vascular vessel wall.

31. The method of claim 23 wherein the remodelable biomaterial comprises an extracellular matrix material.

32. The method of claim 23 wherein the remodelable biomaterial comprises submucosa tissue.

33. The method of claim 23 wherein the remodelable biomaterial comprises collagen.

34. The method of claim 33, wherein said submucosa is porcine, bovine, or ovine submucosa.

35. The method of claim 23 wherein the remodelable biomaterial comprises a bioactive substance.

36. The method of claim 23 wherein the remodelable biomaterial comprises a population of viable cells.

37. The method of claim 36 wherein the cells comprise autologous cells.

38. A method for treating a vascular vessel in a patient comprising introducing a remodelable biomaterial into or externally of a wall of the vessel in a region proximate to an aneurysm or other wall defect, wherein the remodelable biomaterial is effective to shrink as a result of remodeling so as to reshape the vascular vessel.

39. The method of claim 38 wherein said remodelable biomaterial has a flowable state, and said introducing comprises injecting the remodelable biomaterial while in said flowable state.

40. The method of claim 39 wherein the remodelable biomaterial also has a hardened state, and wherein said method also comprises allowing or causing the remodelable biomaterial to change from said flowable state to said hardened state after said injecting.

41. The method of claim 40 wherein said remodelable biomaterial is effective to be thermally induced to change from said flowable state to said hardened state.

42. The method of claim 39 comprising injecting the remodelable biomaterial into two or more sites spaced circumferentially about the vascular vessel.

43. The method of claim 39 wherein said injecting comprises injecting the remodelable biomaterial so as to substantially surround the vascular vessel.

44. The method of claim 38 wherein the remodelable biomaterial comprises a fluidized extracellular matrix material.

45. The method of claim 38 wherein the remodelable biomaterial comprises at least one extracellular matrix material selected from the group consisting of pericardium, submucosa, liver basement membrane, dura mater, peritoneum, serosa, and renal capsule.

46. The method of claim 38, also comprising introducing a population of viable cells with the remodelable biomaterial.

47. The method of claim 46 wherein the cells comprise autologous cells.

48. The method of claim 38 wherein the remodelable biomaterial comprises a bioactive agent.

49. The method of claim 38 wherein said introducing an amount of the remodelable biomaterial sufficient to reinforce the vessel wall.