Methods for treating valve-associated regions of vascular vessels

• US 7,387,604 B2
• Filed: 11/03/2005
• Issued: 06/17/2008
• Est. Priority Date: 11/03/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Flagle, Jacob A, Case, Brian C., Patel, Umesh H., Obermiller, F. Joseph, Hiles, Michael C.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/266,166
• Publication Number:
  US 20060116548A1
• Time in Patent Office: 957 Days
• Field of Search: 600/19, 600/29, 600 36- 37, 623/1.1, 623/1.24, 623/1.25, 623/1.27, 623/1.28, 623/1.38, 623 144- 154, 623/14, 424/93.1, 424/93.7, 128897-899
• 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 27/3839 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 valve-associated region 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 for treating a vein in a patient, said method comprising:

accessing a treatment site proximate to a valve in the vein,

introducing a remodelable biomaterial into, or in contact with an exterior surface of, a wall of the vein at the treatment site, and

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

2. The method of claim 1 wherein the valve is an insufficient valve.

3. The method of claim 1 wherein said introducing includes introducing the remodelable biomaterial external of a wall of the vein.

4. The method of claim 1 wherein said introducing includes introducing the remodelable biomaterial into a wall of the vein.

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

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

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

8. The method of claim 6, wherein said submucosa is porcine, bovine, or ovine submucosa.

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

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

11. The method of claim 10 wherein the cells comprise autologous cells.

12. 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 vein proximate to leaflet bases of the valve.

13. The method of claim 12 comprising bonding the sheet of remodelable biomaterial to itself to form a band about the external connective tissue of the vein.

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

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

16. A method of treating a vein of a patient, said method comprising:

accessing a treatment site along the vein, said treatment site proximate to a valve within the vein; and

introducing a flowable mass of biocompatible material in contact with an exterior surface of a wall of the vein at said treatment site.

17. The method of claim 16 wherein the biocompatible material is a collagen-containing material.

18. The method of claim 16, wherein said flowable mass of biocompatible material is effective to re-shape the vein.

19. The method of claim 16, wherein said flowable mass of biocompatible material is effective to reinforce the vein.

20. The method of claim 16 wherein the biocompatible material comprises a remodelable biomaterial effective to retract upon remodeling so as to re-shape the vein.

21. The method of claim 20 wherein the remodelable biomaterial comprises an extracellular matrix material.

22. The method of claim 21 wherein the remodelable biomaterial comprises submucosa.

23. The method of claim 21, wherein the remodelable biomaterial comprises a fluidized extracellular matrix material.

24. The method of claim 21, wherein the remodelable biomaterial comprises a particulate extracellular matrix material.

25. The method of claim 16 wherein the biocompatible material comprises a population of viable cells.

26. The method of claim 25, wherein said cells comprise autologous cells.

27. A method for treating a vascular vessel in a patient, comprising introducing a remodelable biomaterial into, or in contact with an exterior surface of, a wall of the vessel in a region proximate to a vascular valve in the vessel, wherein said remodelable biomaterial is effective to shrink as a result of remodeling so as to re-shape the vessel.

28. The method of claim 27 wherein said remodelable biomaterial has a flowable state, and said introducing comprises injecting the remodelable biomaterial while in said flowable state.

29. The method of claim 28 wherein said injecting includes injecting the remodelable biomaterial into a site downstream of leaflet bases of the valve.

30. The method of claim 28 wherein said injecting includes injecting the remodelable biomaterial into a site upstream of leaflet bases of the valve.

31. The method of claim 28, wherein said injecting includes injecting the remodelable biomaterial so as to contact an exterior surface of the vascular vessel in a region corresponding to leaflet bases of the valve.

32. The method of claim 28 wherein said injecting includes injecting the remodelable biomaterial into external connective tissue of the vascular vessel.

33. The method of claim 28 wherein said injecting includes injecting the remodelable biomaterial into a middle muscular layer of the vascular vessel.

34. The method of claim 28 wherein said injecting comprises injecting the remodelable biomaterial so as to substantially surround the vascular vessel.

35. The method of claim 27 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.

36. The method of claim 27, also comprising introducing a population of viable cells with the remodelable biomaterial.

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

38. The method of claim 28 comprising injecting the remodelable biomaterial into two or more sites spaced circumferentially about the vascular vessel.

39. The method of claim 28 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.

40. The method of claim 39 wherein said remodelable biomaterial is effective to be thermally induced to change from said flowable state to said hardened state.

41. The method of claim 40, wherein said remodelable biomaterial exhibits said flowable state at a temperature below the body temperature of the patient, and said hardened state at the body temperature of the patient.

42. The method of claim 28 wherein the remodelable biomaterial comprises a radiopaque substance.

43. A method for treating a patient having an insufficient vascular valve, said method comprising:

establishing percutaneous access to a vascular vessel of a patient;

treating a native vascular valve and/or introducing an artificial vascular valve in a vascular vessel of the patient through the percutaneous access; and

reinforcing the vascular vessel in a region proximate to said native vascular valve or artificial vascular valve by implanting a biocompatible material into a wall of the vessel or in contact with an exterior surface of a wall of the vessel.

44. The method of claim 43 wherein the vascular vessel is a vein.

45. The method of claim 43 wherein said reinforcing comprises introducing a flowable biocompatible material in contact with exterior surface of a wall of said vascular vessel.

46. The method of claim 45 wherein the flowable biocompatible material promotes tissue growth in the patient.

47. The method of claim 46 wherein the flowable biocompatible material comprises a remodelable material.

48. The method of claim 47 wherein the flowable biocompatible material comprises an extracellular matrix material.

49. The method of claim 45 wherein the flowable biocompatible material comprises a population of viable cells.

50. The method of claim 49 wherein the cells comprise autologous cells.