Biological stent-graft

• US 6,926,743 B1
• Filed: 05/20/2003
• Issued: 08/09/2005
• Est. Priority Date: 05/21/2002
• Status: Expired due to Fees

• Current Assignee: Timothy A.M. Chuter
• Original Assignee: Timothy A.M. Chuter
• Inventors: Chuter, Timothy A. M.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US10/441,956
• Time in Patent Office: 812 Days
• Field of Search: 623/1.13, 623/1.27, 623/1.28, 623/1.29, 623 138- 148
• US Class Current: 623/1.41
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining

Abstract

A biological stent-graft and a method of making the same wherein a stent is surgically implanted in the lumen of an artery of a mammal, harvesting the stent-graft precursor after the stent has been incorporated into artery wall, fixing the harvested stent-graft precursor, and washing the same to yield a biological stent-graft.

Claims

1. A method of making a biological stent-graft comprising the following steps:

a stent is surgically implanted in the lumen of a blood vessel of a living animal;

the stent is left in place for a sufficient time for the vessel wall to incorporate the stent through tissue ingrowth to yield a stented vessel;

the stented vessel is surgically harvested to yield a biological stent-graft precursor;

the biological stent-graft precursor is washed and cleaned; and

the washed and cleaned biological stent-graft precursor is fixed with a fixation agent; and

after fixation, the fixed biological stent-graft is washed with a sterile solution to remove substantially all of the fixation agent to yield the biological stent-graft.

2. The method according to claim 1 wherein the stent is surgically implanted in the lumen of an artery.

3. The method according to claim 1 wherein the stent is surgically implanted in the lumen of an artery of a mammal.

4. The method according to claim 1 wherein the stent is a metal stent.

5. The method according to claim 1 wherein the stent is a polymeric stent.

6. The method according to claim 1 wherein the living animal is a bovine.

7. The method according to claim 1 wherein the animal is a canine.

8. The method according to claim 1 wherein the animal is a porcine.

9. The method according to claim 1 wherein the stent is surgically implanted by endoscopic means.

10. The method according to claim 1 wherein the stent-graft is surgically implanted by endovascular means.

11. The method according to claim 1 wherein the stent is surgically implanted into the arterial vessels of a young calf or a young pig four to six months prior to the animal'"'"'s scheduled slaughter.

12. The method according to claim 11 wherein the formed biological stent-graft precursor is harvested from the slaughtered calf or pig.

13. The method according to claim 1 wherein the stent is made of a biologically acceptable material that is suitable for implantation and ingrowth by the vessel wall.

14. The method according to claim 1 wherein the stent is partially expanded when implanted into the vessel wall to secure the stent in the vessel and to enhance tissue incorporation of the stent by the vessel wall.

15. The method according to claim 1 wherein unwanted branches extending from the biological stent-graft precursor are ligated after harvesting of the biological stent-graft precursor.

16. The method according to claim 1 wherein after harvesting, and fixing, the biological stent-graft precursor is washed with sterile solution and stored in a sterile solution.

17. The method according to claim 1 wherein the harvested biological stent-graft precursor is fixed with a solution of glutaraldehyde.

18. The method according to claim 17 wherein after fixation, the biological stent-graft is thoroughly washed with a sterile solution to remove all fixation agent.

19. The method according to claim 1 wherein the harvested biological stent-graft precursor is fixed with a solution of gycerol triglycidyl ether solutions.

20. The method according to claim 19 wherein after fixation, the biological stent-graft is thoroughly washed with a sterile solution to remove all fixation agent.

21. A biological stent-graft made by the process of:

surgically implanting a stent in the lumen of a blood vessel of a living animal;

the stent is left in place for a sufficient time for the vessel wall to incorporate the stent through tissue ingrowth to yield a stented vessel;

the stented vessel is surgically harvested to yield a biological stent-graft precursor;

the biological stent-graft precursor is washed and cleaned; and

the washed and cleaned biological stent-graft precursor is fixed with a fixation agent; and

after fixation, the biological stent-graft is washed with a sterile solution to remove substantially all of the fixation agent to yield the biological stent-graft.

22. The biological stent-graft according to claim 21 wherein the stent is surgically implanted in the lumen of an artery.

23. The biological stent-graft according to claim 21 wherein the stent is surgically implanted in the lumen of an artery of a mammal.

24. The biological stent-graft according to claim 21 wherein the stent is a metal stent.

25. The biological stent-graft according to claim 21 wherein the IS stent is a polymeric stent.

26. The biological stent-graft according to claim 21 wherein the living animal is a bovine.

27. The biological stent-graft according to claim 21 wherein the animal is a canine.

28. The biological stent-graft according to claim 21 wherein the animal is a porcine.

29. The biological stent-graft according to claim 21 wherein the stent is surgically implanted by endoscopic means.

30. The biological stent-graft according to claim 21 wherein the stent-graft is surgically implanted by endovascular means.

31. The biological stent-graft according to claim 21 wherein the stent is surgically implanted into the arterial vessels of a young calf or a young pig four to six months prior to the animal'"'"'s scheduled slaughter.

32. The biological stent-graft according to claim 31 wherein the formed biological stent-graft precursor is harvested from the slaughtered calf or pig.

33. The biological stent-graft according to claim 21 wherein the stent is made of a biologically acceptable material that is suitable for implantation and ingrowth by the vessel wall.

34. The biological stent-graft according to claim 21 wherein the stent is partially expanded when implanted into the vessel wall to secure the stent in the vessel and to enhance tissue incorporation of the stent by the vessel wall.

35. The biological stent-graft according to claim 21 wherein unwanted branches extending from the biological stent-graft precursor are ligated after harvesting of the biological stent-graft precursor.

36. The biological stent-graft according to claim 21 wherein after harvesting, and fixing, the biological stent-graft precursor is washed with sterile solution and stored in a sterile solution.

37. The biological stent-graft according to claim 21 wherein the harvested biological stent-graft precursor is fixed with a solution of glutaraldehyde.

38. The biological stent-graft according to claim 37 wherein after fixation, the biological stent-graft is thoroughly washed with a sterile solution to remove all fixation agent.

39. The biological stent-graft according to claim 21 wherein the harvested biological stent-graft precursor is fixed with a solution of gycerol triglycidyl ether solutions.

40. The biological stent-graft according to claim 39 wherein after fixation, the biological stent-graft is thoroughly washed with a sterile solution to remove all fixation agent.