Non-thrombogenic stent jacket

• US 6,254,627 B1
• Filed: 09/17/1998
• Issued: 07/03/2001
• Est. Priority Date: 09/23/1997
• Status: Expired due to Term

• Current Assignee: Amnis Therapeutics Ltd.
• Original Assignee: Diseno Y Desarrollo Medico SA de CV
• Inventors: Freidberg, Carlos Vonderwalde
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/156,034
• Time in Patent Office: 1,020 Days
• Field of Search: 623/1, 623/1.11, 623/1.13, 623/1.14, 623/1.23, 623/1.44, 623/1.27, 623/23.72, 623/23.7, 606/153, 606/194, 606/195
• US Class Current: 623/1.11
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A jacketed stent assembly comprising a tubular, expandable stent, preferably having a metallic framework, jacketed with a cylinder of biocompatible, non-thrombogenic expandable material, such as heterologous tissue, which, in a preferred embodiment, contains a therapeutic or diagnostic agent. In a preferred embodiment, the jacket of the expandable stent is formed of bovine or porcine pericardial tissue. A delivery catheter having an expandable member on its distal extremity may be used to deliver the stent assembly to a desired region in a lumen of a patient. The jacketed stent is expanded to be seated within the body lumen. Self-expanding jacketed stents are also contemplated

Claims

1. A stent assembly for maintaining the patency of a body lumen comprising an expandable stent with a cylindrical jacket formed of biocompatible, non-thrombogenic material, the cylindrical jacket comprising a thinned layer of pericardium having a cut surface formed by removal of an outer layer of the pericardium, wherein the cylindrical jacket is serous pericardium separated from the outer layer of pericardium.

2. The stent of claim 1, wherein the pericardium is selected from the group consisting of bovine pericardium, and porcine pericardium.

3. The stent of claim 2, wherein the pericardium comprises bovine pericardium with cross-linked collagen.

4. The stent of claim 1 including at least one therapeutic or diagnostic agent releasably contained in the cylindrical jacket.

5. The stent assembly of claim 1 wherein the material is expandable.

6. The stent assembly of claim 1 wherein the stent comprises a metallic tubular member.

7. The stent assembly of claim 1 wherein the stent is disposed within the cylindrical jacket.

21. The stent assembly of claim 1, wherein the cylindrical jacket has a length less than a length of the stent.

22. The stent assembly of claim 1, wherein the cylindrical jacket has a length greater than a length of the stent, the length of the cylindrical jacket being not more than 5% greater than the length of the stent.

23. The stent assembly of claim 1, wherein the stent is expandable from an unexpanded configuration to an expanded configuration, and wherein the cylindrical jacket on the unexpanded stent has a circumference larger than a circumference of the stent in the unexpanded configuration, and about equal to a circumference of the stent in the expanded configuration.

8. A method for maintaining the patency of a body lumen comprising the steps of:

a) mounting on a delivery catheter a stent assembly comprising a tubular expandable stent with a cylindrical jacket formed of biocompatible, non-thrombogenic expandable material, the cylindrical jacket comprising a thinned layer of pericardium having a cut surface formed by removal of an outer layer of the pericardium, wherein the cylindrical jacket is serous pericardium separated from the outer layer of pericardium;

b) advancing the delivery catheter through the body lumen until the stent assembly is positioned at a desired location;

c) expanding the stent assembly to anchor it within the body lumen; and

d) withdrawing the delivery catheter.

9. A cylindrical jacket configured to fit over a portion of an intraluminal stent comprising a thinned layer of pericardium having a cut surface formed by removal of an outer layer of the pericardium, wherein the cylindrical jacket is serous pericardium separated from the outer layer of pericardium.

10. The cylindrical jacket of claim 9 having a length of about 4 to about 200 mm.

11. The cylindrical jacket of claim 9 having a length of about 10 to about 50 mm.

12. The cylindrical jacket of claim 9 having a diameter of about 1.5 to about 60 mm.

13. The cylindrical jacket of claim 12 having a diameter of not greater than about 6 mm.

14. The cylindrical jacket of claim 9 having a diameter of about 2.5 to about 5 mm.

15. The cylindrical jacket of claim 9 having a thickness of about 0.05 mm to about 0.20 mm.

16. The cylindrical jacket of claim 9 having a thickness of about 0.1 mm to about 0.15 mm.

17. The cylindrical jacket of claim 9 configured to fit over an outer portion of the intraluminal stent.

18. The cylindrical jacket of claim 9 configured to cover an inner portion of the intraluminal stent.

31. The method of claim 10 including before (a) removing an outer layer of tissue from the pericardium to form the thinned layer of pericardium.

19. An expandable jacketed stent comprising a metallic tubular member configured to expand from a first circumference to a second circumference, and a jacket formed of heterologous tissue on an outer surface of the stert in a folded configuration configured to unfold as the stent expands to the second circumference, wherein the jacket has a circumference on the unexpanded stent larger than the first circumference of the stent, and a circumference on the expanded stent about equal to the second circumference of the stent.

24. The jacketed stent of claim 19 wherein the jacket in the folded configuration on the unexpanded stent has at least one wing configured to unfold upon expansion of the stent to the second circumference.

25. The jacketed stent of claim 24 wherein the jacket has wings on opposite sides of and folded about the unexpanded stent.

26. The jacketed stent of claim 25 wherein the wings are folded in the same direction into an S-shaped configuration.

27. The jacketed stent of claim 25 wherein the wings are folded in opposite directions into a U-shaped configuration.

28. The jacketed stent of claim 24 including at least one securing member releasably fixing the wing prior to expansion of the stent.

29. The jacket stent of claim 19, wherein the jacket is a thinned layer of tissue having a thickness of about 0.05 mm to about 0.20 mm.

20. A method of treating a patient, comprising:

a) providing an elongated delivery catheter having an expandable member on a distal extremity thereof;

b) mounting onto the expandable member on the distal extremity of the delivery catheter an expandable stent configured to expand from a first circumference to a second expanded circumference and having a cylindrical jacket formed of biocompatible, non-thrombogenic expandable material on an outer surface of the stent in a folded configuration having at least one wing configured to unfold as the stent expands to the second circumference, wherein the jacket has a circumference on the unexpanded stent larger than the first circumference of the stent, and a circumference on the expanded stent about equal to the second expanded circumference of the stent;

c) advancing at least the distal extremity of the catheter within a body lumen of the patient until the jacketed stent is disposed at a desired location within the body lumen;

d) expanding the expandable member on the distal extremity of the catheter to expand the jacketed stent mounted thereon and unfold the jacket wing as the stent expands to the second circumference, and fix the expanded jacketed stent within the body lumen; and

e) contracting the expanded expandable member so the elongated delivery catheter can be removed from the patient.

30. The method of claim 20 including removing fluid out of the jacket after (b) and prior to (c).

32. A method of treating a patient, comprising:

a) providing an elongated delivery catheter having an expandable member on a distal extremity thereof;

b) mounting onto the expandable member on the distal extremity of the delivery catheter an expandable stent configured to expand from a first circumference to a second expanded circumference and having a cylindrical jacket formed of biocompatible, non-thrombogenic expandable material on an outer surface of the stent, wherein the jacket on the unexpanded stent has a circumference larger than the first circumference of the stent, and about equal to the second expanded circumference of the stent;

c) removing fluid out of the jacket after (b), and thereafter advancing at least the distal extremity of the catheter within a body lumen of the patient until the jacketed stent is disposed at a desired location within the body lumen;

d) expanding the expandable member on the distal extremity of the catheter to expand the jacketed stent mounted thereon and fix the expanded jacketed stent within the body lumen; and

e) contracting the expanded expandable member so the elongated delivery catheter can be removed from the patient.