Sealable attachment of endovascular stent to graft

• US 20040230289A1
• Filed: 05/15/2003
• Published: 11/18/2004
• Est. Priority Date: 05/15/2003
• Status: Abandoned Application

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Spiridigliozzi, John, DiMatteo, Kristian, Thistle, Robert C.
• Application Number:
  US10/438,409
• Publication Number:
  US 20040230289A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An endovascular prosthesis of the present invention includes an expandable stent and a means for sealably attaching a tubular graft to the stent within the stent'"'"'s lumen. The means of sealably attaching a graft includes membranes, foams, polymeric materials and combinations thereof. Additionally, the present invention includes methods of forming an endovascular prosthesis and methods of implanting an endovascular prosthesis within a vessel to provide sealable securement of a tubular graft within the stent'"'"'s lumen.

Claims

1. An endovascular prosthesis comprising:

(a) an expandable stent having a distal end, a proximal end and an inner lumen; and

(b) a membrane supported by said stent and extending across said lumen, said membrane including a graft receiving member for sealably receiving at least one tubular graft therethrough.

2. An endovascular prosthesis of claim 1, wherein said graft receiving member comprises a slit.

3. An endovascular prosthesis of claim 2, wherein said graft receiving member is electrostatically spun material.

4. An endovascular prosthesis of claim 1, wherein said graft receiving member comprises a valve.

5. An endovascular prosthesis of claim 1, wherein said graft receiving member comprises a weakened section.

6. An endovascular prosthesis of claim 1, wherein said graft receiving member comprises a penetrable material.

7. An endovascular prosthesis of claim 1, further comprising a second graft receiving member.

8. In combination, an endovascular prosthesis of claim 1, and a tubular graft extending sealably through said graft receiving member.

9. The combination of claim 8, wherein said tubular graft has an interior surface and exterior surface, and an expandable foam on said exterior surface, said foam being expandable within said graft receiving member, sealably securing said tubular graft to said graft receiving member.

10. An endovascular prosthesis of claim 8, further comprising a polymeric material sealably securing said tubular graft to said membrane.

11. A method of forming an endovascular prosthesis comprising the steps of:

a. providing an expandable stent defining a lumen therein comprising distal end and a proximal end;

b. providing a membrane including a graft receiving member for sealably receiving at least one tubular graft therethrough; and

c. attaching said membrane to said stent, wherein said membrane extends across said lumen and is supported thereby.

12. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, a radially expandable stent having a distal end, a proximal end and an inner lumen; and

a membrane supported by said stent and extending across said lumen, said membrane including a graft receiving member for sealably receiving at least one tubular graft therethrough;

b. delivering said stent within a vessel to an area of implantation; and

c. permitting said stent to radially expand to a second diameter; and

thereby engage a vessel wall.

13. A bifurcated endovascular prosthesis comprising:

(a) a first prosthetic component comprising;

(i) an expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a membrane extending transversely across said inner lumen and attached to said stent, said membrane having an opening; and

(b) a second prosthetic component extending into said opening in a substantially fluid tight seal, said second component comprising a branched graft.

14. A bifurcated endovascular prosthesis of claim 13, wherein said membrane has a first opening and a second opening.

15. A bifurcated endovascular prosthesis of claim 14, wherein said branched graft comprises a first graft extending into said first opening, and a second graft extending into said second opening in a substantially fluid-tight seal.

16. A bifurcated endovascular prosthesis of claim 15, wherein said membrane comprises polyurethane, polyethylene, polytetrafluoroethylene, and combinations thereof.

17. A bifurcated endovascular prosthesis of claim 15, wherein said first opening and second opening each comprises a valve.

18. A bifurcated endovascular prosthesis of claim 15, wherein said first prosthetic component is adapted to reside in an aortic artery, and said first graft and second graft are each adapted to respectively reside in separate iliac arteries.

19. A method of forming a bifurcated endovascular prosthesis comprising the steps of:

a. providing a first prosthetic component comprising;

(i) an expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a membrane extending transversely across said inner lumen and attached to said stent, said membrane having an opening;

b. providing a second prosthetic component comprising a branched graft; and

c. extending said second prosthetic component into said opening of said membrane, wherein said membrane forms a substantially fluid tight seal with said second component.

20. A method of implanting a bifurcated endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, a first prosthetic component comprising an expandable stent having a distal end, a proximal end and an inner lumen; and

a membrane extending transversely across said inner lumen and attached to said stent, said membrane having an opening;

b. providing a second prosthetic component comprising a branched graft;

c. delivering said first prosthetic component within a vessel to an area of implantation;

d. permitting said first prosthetic component to radially expand to a second diameter; and

thereby engage a vessel wall; and

e. delivering said second prosthetic component within said opening of said stent forming a substantially fluid tight seal between said membrane and said second prosthetic component.

21. A method of forming a bifurcated endovascular prosthesis comprising the steps of:

a. providing a prosthetic component comprising;

(i) an expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a membrane extending transversely across said inner lumen and attached to said stent, said membrane having a first opening and a second opening;

b. providing a first graft having a first inner surface, a first outer surface defining a first interior lumen;

c. providing a second graft having a second inner surface, a second outer surface defining a second interior lumen;

d. extending said first graft into said first opening of said membrane, wherein said membrane forms a substantially fluid tight seal between said prosthetic component and said first graft; and

e. extending said second graft into said second opening of said membrane, wherein said membrane forms a substantially fluid tight seal between said prosthetic component and said second graft.

22. A method of implanting a bifurcated endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, a prosthetic component comprising an expandable stent having a distal end, a proximal end and an inner lumen; and

a membrane extending transversely across said inner lumen and attached to said stent, said membrane having an opening;

b. providing a first graft having a first inner surface, a first outer surface defining a first interior lumen;

c. providing a second graft having a second inner surface, a second outer surface defining a second interior lumen;

d. delivering said prosthetic component within a vessel to an area of implantation;

e. permitting said prosthetic component to radially expand to a second diameter; and

thereby engage a vessel wall;

f. delivering said first graft within said opening of said stent forming a substantially fluid tight seal between said membrane and said first graft; and

g. delivering said second graft within said opening of said stent forming a substantially fluid tight seal between said membrane and said second graft.

23. An endovascular prosthesis comprising:

(a) an expandable stent having an inner lumen, a first end and a second end; and

(b) a membrane attached to said stent extending transversely across said lumen, said membrane comprising electrostatically spun material having a graft receiving opening for sealably receiving at least one tubular graft therethrough.

24. In combination, an endovascular prosthesis of claim 23, and at least one tubular prosthesis extending through said graft receiving opening and sealably supporting said at least one tubular prosthesis.

25. A method of forming an endovascular prosthesis comprising the steps of:

a. providing an expandable stent having an inner lumen, a first end and a second end;

b. providing a membrane comprising electrostatically spun material having a graft receiving opening for sealably receiving at least one tubular graft therethrough; and

c. attaching said membrane to said stent, wherein said membrane extends transversely across said lumen and is supported thereby.

26. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, an expandable stent having a first end, a second end and an inner lumen; and

a membrane comprising electrostatically spun material supported by said stent and extending across said lumen, said membrane including a graft receiving opening for sealably receiving at least one tubular graft therethrough;

b. delivering said stent within a vessel to an area of implantation; and

c. permitting said stent to radially expand to a second diameter; and

thereby engage a vessel wall.

27. A multi-component endovascular prosthetic system comprising:

(a) a first expandable prosthesis comprising;

(i) a first expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a first membrane extending transversely across said inner lumen and attached to said first stent, said first membrane having a first graft receiving opening;

(b) a second expandable prosthesis spaced from said first prosthesis comprising;

(i) a second expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a second membrane extending transversely across said inner lumen and attached to said second stent, said second membrane having a second graft receiving opening; and

(c) a tubular graft extending sealably through said first graft receiving opening and said second graft receiving opening for directing fluid through said tubular graft.

28. A multi-component endovascular prosthetic system of claim 27, wherein said tubular graft has a porous portion disposed between said first expandable prosthesis and said second expandable prosthesis to allow for fluid flow through said porous portion.

29. A multi-component endovascular prosthetic system of claim 28, wherein said porous portion comprises a stent.

30. A multi-component endovascular prosthetic system of claim 28, wherein said porous portion comprises slits.

31. A multi-component endovascular prosthetic system of claim 28, wherein said porous portion comprises fluid permeable material.

32. A multi-component endovascular prosthetic system of claim 27, wherein said first membrane has a pair of first graft receiving openings, said graft receiving openings each receiving a tubular graft therethrough.

33. A multi-component endovascular prosthetic system of claim 32, wherein said first membrane has a fluid flow opening.

34. A multi-component endovascular prosthetic system of claim 33, wherein said second membrane has a pair of second graft receiving openings, said second graft receiving openings each receiving a tubular graft therethrough.

35. A method of forming a multi-component endovascular prosthesis comprising the steps of:

a. providing a first expandable prosthesis comprising;

(i) a first expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a first membrane extending transversely across said inner lumen and attached to said first stent, said first membrane having a first graft receiving opening;

b. providing a second expandable prosthesis spaced from said first prosthesis comprising;

(i) a second expandable stent having a distal end, a proximal end and an inner lumen; and

(ii) a second membrane extending transversely across said inner lumen and attached to said second stent, said second membrane having a second graft receiving opening; and

c. providing a tubular graft having an outer surface, and an inner surface defining an inner lumen; and

d. extending said tubular graft through said first graft receiving opening and said second graft receiving opening for directing fluid through.

36. A method of implanting a multi-component endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, a first expandable prosthesis comprising a first expandable stent having a distal end, a proximal end and an inner lumen; and

a first membrane extending transversely across said inner lumen and attached to said first stent, said first membrane having a first receiving opening;

b. providing, in a compressed second diameter, a second expandable prosthesis comprising a second expandable stent having a distal end, a proximal end and an inner lumen; and

a second membrane extending transversely across said inner lumen and attached to said second stent, said second membrane having a second receiving opening;

c. providing a tubular graft having an outer surface, and an inner surface defining a graft inner lumen;

d. delivering said first expandable prosthesis within a vessel to an area of implantation;

e. permitting said first expandable prosthesis to radially expand to a third diameter; and

thereby engage a vessel wall;

f. delivering said second expandable prosthesis spaced from said first expandable prosthesis within a vessel to an area of implantation;

g. permitting said second expandable prosthesis to radially expand to a fourth diameter; and

thereby engage a vessel wall;

h. delivering said tubular graft within said first receiving opening and said second receiving opening forming a substantially fluid tight seal between said first membrane and said tubular graft, and said second membrane and said tubular graft.

37. An endovascular prosthesis comprising:

(a) a stent having an inner lumen, a distal end and a proximal end, said distal end having an opening, and said proximal end having two openings opposing said distal opening; and

(b) a puncturable membrane extending across each of said proximal end openings.

38. In combination, an endovascular prosthesis of claim 37, and at least one tubular graft extending through said distal end opening and puncturably through one of said membranes at said proximal end, thereby forming a fluid seal between said tubular graft and said stent at said proximal end.

39. The combination of claim 38, further comprising a pair of tubular grafts extending through said distal end, with one tubular graft extending puncturably through each membrane at said proximal end of said stent to thereby form a fluid seal between said tubular graft and said stent at said proximal end.

40. A method of forming an endovascular prosthesis comprising the steps of:

a. providing an expandable stent having an inner lumen, a distal end and a proximal end, wherein said distal end having an opening and said proximal end having two openings opposing said distal opening;

b. providing a puncturable membrane; and

c. attaching said membrane to said stent transversely across each of said proximal end openings.

41. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, an expandable stent having a distal end, a proximal end and an inner lumen, wherein said distal end having an opening and said proximal end having two openings opposing said distal opening; and

a puncturable membrane supported by said stent and extending across said lumen;

b. delivering said stent within a vessel to an area of implantation; and

c. permitting said stent to radially expand to a second diameter; and

thereby engage a vessel wall.

42. An endovascular prosthesis comprising:

(a) an expandable stent having a distal end, a proximal end, and an opening extending therethrough;

(b) a first graft attached to said distal end of said stent within said opening, and having an inner lumen extending therethrough;

(c) a second graft attached to said proximal end of said stent within said opening and spaced from said first graft, said second graft having at least two inner lumens extending therethrough; and

(d) a membrane extending transversely across each of said inner lumens of said second graft.

43. In combination, an endovascular prosthesis of claim 42, and at least two tubular prosthesis, one of such prosthesis extending puncturably through each of said respective membranes.

44. A method of forming an endovascular prosthesis comprising the steps of:

a. providing an expandable stent having a distal end and a proximal end, and an opening extending therethrough;

b. providing a first graft having an inner lumen extending therethrough;

c. providing a second graft having at least two inner lumens extending therethrough;

d. providing a membrane;

e. attaching said first graft to said distal end of said stent within said opening;

f. attaching said second graft to said proximal end of said stent within said opening and spaced from said first graft; and

g. attaching said membrane transversely across each of said inner lumens of said second graft.

45. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, an expandable stent having a distal end, a proximal end and an opening therethrough, said stent comprising a first graft attached to said distal end of said stent within said opening, and having an inner lumen extending therethrough;

a second graft attached to said proximal end of said stent within said opening and spaced from said first graft, said second graft having at least two inner lumens extending therethrough; and

a membrane extending transversely across each of said inner lumens of said second graft;

b. delivering said stent within a vessel to an area of implantation; and

c. permitting said stent to radially expand to a second diameter; and

thereby engage a vessel wall.

46. An endovascular prosthetic assembly comprising:

(a) an expandable stent having a distal end, a proximal end and an inner lumen having an inner surface and an outer surface;

(b) a tubular graft inserted within said inner lumen, said tubular graft having an interior surface and exterior surface; and

(c) an expanded foam attached to said exterior surface of said graft, said expanded foam sealably securing said tubular graft to said stent.

47. An endovascular prosthesis of claim 46, wherein said expanded foam is adhesively bonded to said exterior surface of said graft.

48. An endovascular prosthesis of claim 46, wherein said expanded foam is mechanically fastened to said exterior surface of said graft.

49. An endovascular prosthesis of claim 46, further comprising a second tubular graft inserted within said inner lumen, said second tubular graft having a second interior surface and a second exterior surface, and a second expanded foam bonded to said second exterior surface, said second expanded foam sealably securing said second tubular graft to said stent.

50. A kit of parts for assembly into an endovascular prosthetic system, comprising:

(a) an expandable stent having a distal end, a proximal end and an inner lumen for insertion into a body endovascularly;

(b) a tubular graft adapted to be inserted within said inner lumen, said tubular graft having an interior surface for body fluid flow and an exterior surface; and

(c) an expandable foam on said exterior surface of said tubular graft, said expandable foam adapted to expand within said stent to sealably secure said tubular graft to said stent.

51. A method of forming an endovascular prosthesis comprising the steps of:

a. providing an expandable stent having a distal end, a proximal end and an inner lumen having an inner surface and an outer surface;

b. providing a tubular graft having an interior surface and exterior surface;

c. providing an expandable foam;

d. attaching said expandable foam to said exterior surface of said graft;

e. inserting said tubular graft within said inner lumen of said stent, wherein said expandable foam is in a compressed state; and

f. allowing said expandable foam to expand within said stent and sealably securing said tubular graft within said stent.

52. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, an expandable stent having a distal end, a proximal end, an inner surface, an outer surface and an inner lumen;

b. providing a tubular graft having an interior surface and an exterior surface, said tubular graft having, in a compressed second diameter, an expandable foam attached to said exterior surface of said graft;

c. delivering said stent within a vessel to an area of implantation;

d. permitting said stent to radially expand to a third diameter; and

thereby engage a vessel wall;

e. delivering said graft within said inner lumen of said stent; and

f. permitting said foam of said graft to expand to a fourth diameter, thereby sealably securing said graft to said stent.

53. An endovascular prosthetic assembly comprising:

(a) a stent having an inner surface and an outer surface;

(b) a tubular graft extending within said inner lumen, said tubular graft having an interior surface and an exterior surface, and an opening therethrough; and

(c) a polymeric material sealably supporting said tubular graft to said stent.

54. An endovascular prosthetic assembly of claim 53 wherein said polymeric material is a hydrogel.

55. An endovascular prosthesis of claim 53, further comprising a second tubular graft extending within said inner lumen, said second tubular graft having an interior surface and an exterior surface, and an opening therethrough;

and said polymeric material sealably supporting said second tubular graft to said stent.

56. A kit of parts for assembly into an endovascular prosthetic system comprising:

(a) a stent having an inner surface, an outer surface and an inner lumen, a primary reactive material being disposed on said inner surface;

(b) a tubular graft adapted to extend within said inner lumen, said graft having an interior surface and an exterior surface, said primary material being disposed on said exterior surface; and

(c) a secondary material reactive with said primary material and adapted to be applied to said primary material upon insertion of said graft within said inner lumen, said secondary material being reactive with said primary material to form a seal between said graft and said stent.

57. A method of forming an endovascular prosthesis comprising the steps of:

a. providing a stent having an inner surface, an outer surface and an inner lumen;

b. providing a tubular graft having an interior surface and an exterior surface, and an opening therethrough;

c. providing a primary material;

d. providing a secondary material reactive with said primary material;

b. disposing said primary material on said inner surface of said stent;

e. disposing said primary material on said exterior surface of said tubular graft;

f. inserting said tubular graft within said inner lumen of said stent; and

g. introducing said secondary material into said inner lumen of said stent, wherein said secondary material react with said primary material defining a polymeric material sealably supporting said tubular graft to said stent.

58. A method of implanting an endovascular prosthesis within a vessel comprising:

a. providing, in a compressed first diameter, an expandable stent having an inner surface, an outer surface and an inner lumen therethrough, said inner surface of said stent having a primary material disposed about said surface;

b. providing a tubular graft having an interior surface and an exterior surface, said exterior surface of said graft having a primary material disposed about said surface;

c. providing a secondary material reactive with said primary material;

d. delivering said stent within a vessel to an area of implantation;

e. permitting said stent to radially expand to a second diameter; and

thereby engage a vessel wall;

f. delivering said graft within said inner lumen of said stent;

g. delivering said second material into said inner lumen of said stent; and

h. permitting said secondary material to react with said primary material defining a polymeric material sealably supporting said tubular graft to said stent.

59. An endovascular prosthesis comprising:

(a) an expandable stent having a distal end, a proximal end and an inner lumen; and

(b) means for sealably attaching a tubular graft to said stent within said lumen.

60. An endovascular prosthesis of claim 59, wherein said means comprises a membrane supported by said stent and extending across said lumen, said membrane including a graft receiving member for sealably receiving at least one tubular graft therethrough.

61. An endovascular prosthesis of claim 59, wherein said means comprises an expandable foam bonded to said tubular graft.

62. An endovascular prosthesis of claim 59, wherein said means comprises a polymeric material, said polymeric material comprising the reaction product of a primary material on said inner lumen of said stent and on said tubular graft, and a secondary material thereby forming a sealed attachment between said tubular graft and said stent.