Tubular prosthesis for external agent delivery

• US 20030074048A1
• Filed: 10/16/2001
• Published: 04/17/2003
• Est. Priority Date: 10/16/2001
• Status: Active Grant

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Sherry, John E.
• Granted Patent: US 7,033,389 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

A tubular prosthesis, which may be an endovascular prothesis, is provided which includes a tubular member (stent or stent/graft combination) and an outer covering having portions sealed to the tubular member. The tubular member is impervious to a pre-determined fluid, particularly an occluding fluid, while the outer cover is pervious to the pre-determined fluid. In one aspect of the present invention, the implantation of the prosthesis allows for occluding fluid to weep from the prosthesis and into a sac of an aneurysm to cause occlusion thereof without introducing the occluding fluid into the blood stream. In this manner, a Type II failure of the prosthesis may be avoided. In other aspects of the invention, therapeutic agents may be delivered and/or a seal may be formed about the prosthesis to prevent a Type I failure.

Claims

1. A tubular prosthesis comprising:

a tubular member having a wall with an inner surface and an outer surface, said wall being impervious to transmission therethrough of a pre-determined fluid; and

an outer covering having portions sealed to said outer surface of said tubular member, said outer cover being pervious to transmission therethrough of said pre-determined fluid.

2. As prosthesis as in claim 1, wherein said tubular member is formed of a polymeric material.

3. A prosthesis as in claim 1, wherein said tubular member is formed of a textile material.

4. A prosthesis as in claim 1, wherein said tubular member includes a polymeric material and a textile material.

5. A prosthesis as in claim 1, wherein said outer covering is generally coextensive with said tubular member.

6. A prosthesis as in claim 1, wherein said tubular member has a first opening, said outer covering being sealed to said tubular member in proximity to said first opening.

7. A prosthesis as in claim 1, wherein said tubular member is cylindrical.

8. A prosthesis as in claim 1, wherein said tubular member is generally Y-shaped with a single lumen being in fluid communication with two minor lumens.

9. A prosthesis as in claim 1, wherein said outer covering is a porous material.

10. A prosthesis as in claim 1, wherein cut apertures are formed in said outer covering.

11. A prosthesis as in claim 10, wherein said cut apertures are each generally equal in size.

12. A prosthesis as in claim 10, wherein said cut apertures are of various sizes.

13. A prosthesis is as in claim 10, wherein said cut apertures are unevenly dispersed.

14. A prosthesis as in claim 1, further comprising a fluid conduit having an end communicating with space defined between said tubular member and said outer cover, said fluid conduit formed to convey said pre-determined fluid to said space.

15. A prosthesis as in claim 14, wherein said end of said fluid conduit directly communicates with said space with said end being located in said space.

16. A prosthesis as in claim 14, wherein said end indirectly communicates with said space via a valve.

17. A prosthesis as in claim 14, wherein said outer covering is increasingly pervious to transmission therethrough of said predetermined fluid at locations increasingly further from said end of said fluid conduit.

18. A prosthesis as in claim 17, wherein cut apertures are formed in said outer covering, said cut apertures being increasingly larger as located increasingly further located from said end of said fluid conduit.

19. A prosthesis as in claim 17, wherein cut apertures are formed in said outer covering, the density of said cut apertures increasing with distance from said end of said fluid conduit.

20. A prosthesis as in claim 17, wherein said outer covering is increasingly porous at locations increasingly further from said end of said fluid conduit.

21. A prosthesis as in claim 1, wherein said pre-determined fluid is an occluding fluid.

22. A prosthesis as in claim 21, wherein said occluding fluid is an embolic liquid selected from the group consisting of algenates, hyleronic acid, cyanoacrylates, and admixtures thereof.

23. A prosthesis as in claim 21, wherein said occluding fluid is selected from the group consisting of sclerosing agents, polyurethanes, silicones, and admixtures thereof.

24. A prosthesis as in claim 21, wherein said occluding fluid includes thrombin.

25. A prosthesis as in claim 21, wherein said occluding fluid includes an autologous clot.

26. A prosthesis as in claim 1, wherein said tubular member is a graft.

27. A prosthesis as in claim 1, wherein said tubular member is a stent/graft combination.

28. A prosthesis as in claim 27, wherein said stent is expandable.

29. A prosthesis as in claim 28, wherein said stent is self-expanding.

30. A prosthesis as in claim 1, wherein said sealed portions of said outer covering at least partially bound a pocket for receiving said pre-determined fluid.

31. A prosthesis as in claim 30, wherein said pocket is generally coextensive with said tubular member.

32. A prosthesis as in claim 1, wherein said pre-determined fluid is a therapeutic agent.

33. A prosthesis as in claim 1, wherein the prosthesis is an endovascular prosthesis.

34. A method of occluding a sac of an aneurysm, the method comprising the steps of:

implanting endovascularly an endovascular prosthesis which by-passes the aneurysm, said endovascular prosthesis including a tubular member having a wall, said wall being impervious to transmission therethrough of an occluding fluid, and an outer covering having portions sealed to said tubular member, said outer covering being pervious to transmission therethrough of said occluding fluid; and

conveying a dose of occluding fluid into a pocket at least partially defined between said tubular member and said outer covering, said dose being an effective amount to at least partially occlude the sac of the aneurysm, whereby said occluding fluid transmits through said outer covering to at least partially occlude the sac of the aneurysm.

35. A method as in claim 34 further comprising the step of placing a fluid conduit into fluid communication with said pocket.

36. A method as in claim 35, wherein the step of conveying a dose of occluding fluid includes conveying said occluding fluid via said fluid conduit.

37. A method as in claim 35, wherein the step of placing a fluid conduit is performed before the step of implanting endovascularly.

38. A method as in claim 37, further comprising the step of detaching said fluid conduit from said endovascular prosthesis after the step of conveying a dose of occluding fluid.

39. A method as in claim 34, wherein said occluding fluid is an embolic liquid selected from the group consisting of algenates, hyleronic acid, cyanoacrylates, and admixtures thereof.

40. A method as in claim 34, wherein said occluding fluid is selected from the group consisting of sclerosing agents, polyurethanes, silicones, and admixtures thereof.

41. A method as in claim 34, wherein said occluding fluid includes thrombin.

42. A method as in claim 34, wherein said occluding fluid includes an autologous clot.

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

providing a tubular member which includes a wall, said wall being impervious to transmission therethrough of a pre-determined fluid; and

sealing portions of an outer covering to said tubular member, said outer covering being pervious to transmission therethrough of said predetermined fluid.

44. A method as in claim 43, further comprising the step of placing a fluid conduit in direct fluid communication with a pocket at least partially defined between said tubular member and said outer covering.

45. A method as in claim 43, further comprising the step of placing a fluid conduit in indirect fluid communication with a pocket at least partially defined between said tubular member and said outer covering.

46. A method as in claim 45, wherein the step of placing a fluid conduit includes mounting a valve in fluid communication with said pocket, and connecting said fluid conduit to said valve.

47. A method as in claim 43, further comprising the step of making said outer covering be pervious to transmission therethrough of said pre-determined fluid.

48. A method as in claim 47, wherein the step of making includes cutting apertures in said outer covering.

49. A method as in claim 47, wherein the step of making includes forming said outer covering with porosity.

50. A method as in claim 43, wherein the step of sealing includes fusing portions of said outer covering to said tubular member.

51. A method as in claim 43, wherein the step of sealing includes bonding portions of said outer covering to said tubular member.

52. A method of administering a therapeutic agent, the method comprising the steps of:

implanting a tubular prosthesis, said prosthesis including a tubular member having a wall, said wall being impervious to transmission therethrough of a pre-determined therapeutic agent, and an outer covering having portions sealed to said tubular member, said outer covering being pervious to transmission therethrough of said pre-determined therapeutic agent; and

conveying a dose of said pre-determined therapeutic agent into a pocket at least partially defined between said tubular member and said outer covering.

53. A method as in claim 52, further comprising the step of placing a fluid conduit into fluid communication with said pocket.

54. A method as in claim 53, wherein the step of conveying a dose of pre-determined therapeutic agent includes conveying said predetermined therapeutic agent via said fluid conduit.

55. A method as in claim 53, wherein the step of placing a fluid conduit is performed before the step of implanting endovascularly.

56. A method as in claim 55, further comprising the step of detaching said fluid conduit from said prosthesis after the step of conveying a dose of pre-determined therapeutic agent.

57. A method of at least partially forming a seal between a tubular prosthesis and a bodily passageway, the method comprising the steps of:

implanting a tubular prosthesis into a bodily passageway, said prosthesis including a tubular member having a wall, said wall being impervious to transmission therethrough of an occluding fluid, and an outer covering having portions sealed to said tubular member, said outer covering being pervious to transmission therethrough of said occluding fluid; and

conveying a dose of occluding fluid into a pocket at least partially defined between said tubular member and said outer covering, said dose being an effective amount to at least partially occlude an area about said tubular member so as to at least partially form a seal between said prosthesis and portions of the bodily passageway.

58. A method as in claim 57, wherein said occluding fluid is an embolic liquid selected from the group consisting of algenates, hyleronic acid, cyanoacrylates, and admixtures thereof.

59. A method as in claim 57, wherein said occluding fluid is selected from the group consisting of sclerosing agents, polyurethanes, silicones, and admixtures thereof.

60. A method as in claim 57, wherein said occluding fluid includes thrombin.

61. A method as in claim 57, wherein said occluding fluid includes an autologous clot.