CA2415976A1 - Bilateral extension prosthesis and method of delivery - Google Patents

Bilateral extension prosthesis and method of delivery Download PDF

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Publication number
CA2415976A1
CA2415976A1 CA002415976A CA2415976A CA2415976A1 CA 2415976 A1 CA2415976 A1 CA 2415976A1 CA 002415976 A CA002415976 A CA 002415976A CA 2415976 A CA2415976 A CA 2415976A CA 2415976 A1 CA2415976 A1 CA 2415976A1
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Canada
Prior art keywords
prosthesis
extension
bypass
stent
engage
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002415976A
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French (fr)
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CA2415976C (en
Inventor
Frank Butaric
William L. Howat
Robert P. Letendre
Marc Ramer
Kenneth S. Solovay
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Cordis Corp
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Cordis Corp
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Publication of CA2415976A1 publication Critical patent/CA2415976A1/en
Application granted granted Critical
Publication of CA2415976C publication Critical patent/CA2415976C/en
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Expired - Fee Related legal-status Critical Current

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2230/0028—Shapes in the form of latin or greek characters
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    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Abstract

The invention is a system, apparatus, and method for treating, and/or repairing an aneurysm, preferably an aortic aneurysm, and most preferably, an abdominal aortic aneurysm. The systems, devices, and methods of the present invention include a prosthesis assembly for establishing a fluid flow path between an upstream portion of an artery and at least one bifurcated downstream portion of the artery.

Claims (81)

1. A system for bypassing an aneurysm comprising at least one bypass prosthesis and at feast one extension prosthesis, said bypass prosthesis comprising an extension receptacle in a distal portion thereof, said extension prosthesis having a proximal portion adapted to engage the extension receptacle.
2. The system of claim 1 further comprising an extension receptacle having a first portion adapted to receive a first extension prosthesis and a second portion adapted to receive a second extension prosthesis; said system further comprising a first extension prosthesis having a proximal portion configured to engage the first portion of the extension receptacle, and a second extension prosthesis having a proximal portion configured to engage the second portion of the extension receptacle.
3. The system of claim 1 wherein the bypass prosthesis comprises a stent and a graft material communicating with the stent.
4. The system of claim 3 wherein said stent and graft material defines a fluid flow path through the prosthesis.
5. The system of claim 1 wherein the extension prosthesis comprises a stent and a graft material communicating with the stent.
6. The system of claim 5 wherein said stent and graft material defines a fluid flow path through the prosthesis.
7. The system of claim 1 wherein a distal portion of the bypass prosthesis is adapted to engage a proximal portion of the extension prosthesis.
8. The system of claim 7 wherein the distal portion of the bypass prosthesis comprises at least one anchor.
9. The system of claim 8 wherein the anchor is configured to engage a complementary structure on the proximal portion of the extension prosthesis.
10. The system of claim 9 wherein the anchor is further adapted to engage a complementary structure on a delivery device.
11. The system of claim 1 wherein the extension receptacle comprises at least one aperture configured to receive a proximal portion of the extension prosthesis.
12. The system of claim 11 wherein the extension receptacle comprises two apertures, each aperture configured to receive a proximal portion of an extension prosthesis.
13. The system of claim 11 wherein the extension receptacle further comprises a gasket for sealingly receiving a proximal portion of the extension prosthesis.
14. The system of claim 12 wherein the extension receptacle further comprises a gasket for sealingly receiving a proximal portion of the extension prosthesis.
15. The system of claim 1 wherein the extension receptacle is shaped to seal a distal end of the bypass prosthesis.
16. The system of claim 11 wherein the extension receptacle is shaped to seal a distal end of the bypass prosthesis.
17. The system of claim 13 wherein the gasket is shaped to seal a distal end of the bypass prosthesis.
18. The system of claim 5 wherein the stent is a self-expanding stent.
19. The system of claim 18 wherein the stent is formed from at least one metal.
20. The system of claim 18 wherein the stent is formed from a nickel titanium alloy.
21. The system of claim 19 wherein the stent is formed from nitinol.
22. The system of claim 5 wherein the stent comprises a matrix of interconnected struts.
23. The system of claim 18 wherein the stent comprises a matrix of interconnected struts.
24. The system of claim 23 wherein the matrix comprises at feast one geometric shape.
25. The system of claim 23 wherein the interconnected struts form at least one geometric shape.
26. The system of claim 24 wherein the matrix comprises a plurality of geometric shapes.
27. The system of claim 26 wherein the plurality of geometric shapes is positioned in an intermediate portion of said stent between the proximal end and the distal end of the stent.
28. The system of claim 24 wherein the geometric shape is a diamond.
29. The system of claim 24 wherein the matrix is formed of at least one hoop.
30. The system of claim 29 wherein the matrix is formed of a distal hoop, a proximal hoop, and at least one intermediate hoop interposed between the distal hoop and the proximal hoop.
31. The system of claim 30 wherein the distal hoop is stiffer than the intermediate hoop.
32. The system of claim 30 wherein the proximal hoop is stiffer than the intermediate hoop.
33. The system of claim 30 wherein the distal hoop and the proximal hoop are stiffer than the intermediate hoop.
34. The system of claim 30 wherein the intermediate hoop is more flexible than the proximal hoop.
35. The system of claim 34 wherein the intermediate hoop is more flexible than the distal hoop.
36. The system of claim 5 wherein the graft material engages an inner surface of the stent, an outer surface of the stent, or combinations thereof.
37. The system of claim 36 wherein the graft material is connected to the stent.
38. The system of claim 5 further comprising at least one connector for attaching the graft material to the stent.
39. The system of claim 38 wherein the connector is a staple or suture.
40. The system of claim 39 wherein the connector comprises at least one end configured into a nub.
41. The system of claim 40 wherein the connector comprises two ends, each of the two ends being configured into a nub.
42. The system of claim 5 wherein the graft material is formed from a polyester, a fluoroethylene, a polyurethane, a polyethylene terephthlate, a silicone, or combinations thereof.
43. The system of claim 42 wherein the graft material is formed from a polyethylene terephthlate, a polytetrafluoroethylene, or combinations thereof.
44. The system of claim 5 wherein the graft material is pleated.
45. The system of claim 43 wherein the graft material is pleated.
46. The system of claim 23 wherein the matrix comprises at least one ring.
47. The system of claim 29 wherein the matrix comprises at feast one ring.
48. The system of claim 47 wherein the matrix comprises at least one ring interposed between two hoops.
49. The system of claim 46 wherein the ring is formed from the ends of a plurality of interconnected struts.
50. The system of claim 1 wherein the proximal portion of the extension prosthesis further comprises a gasket for sealingly engaging the bypass prosthesis.
51. The system of claim 1 wherein the proximal portion of the extension prosthesis further comprises a gasket for sealingly engaging the extension receptacle.
52. The system of claim 1 wherein the extension prosthesis further comprises a distal portion configured to engage an artery.
53. The system of claim 52 wherein the distal portion of the bypass prosthesis comprises at least one anchor.
54. The system of claim 53 wherein the anchor is further adapted to engage a complementary structure on a delivery device.
55. The system of claim 1 further comprising a first prosthesis adapted to engage a proximal portion of said bypass prosthesis.
56. The system of claim 55 wherein the first prosthesis comprises a stent and a gasket material communicating with the stent.
57. The system of claim 55 further comprising one or more connectors for matingly engaging the first prosthesis with the bypass prosthesis, said at least one connector comprising a connector having two ends, each of the two ends being configured into a nub.
58. The system of claim 55 wherein the first prosthesis is adapted to engage a portion of an artery upstream of an aneurysm.
59. The system of claim 58 wherein the first prosthesis comprises at least one distally extending flange.
60. The system of claim 59 wherein the flange comprises an anchor on a distal end.
61. The system of claim 60 wherein said anchor is further adapted to engage a complementary structure on a delivery device.
62. The system of claim 55 wherein a proximal portion of the first prosthesis is adapted to engage a proximal portion of the bypass prosthesis.
63. The system of claim 62 wherein the proximal portion of the first prosthesis is adapted to engage a proximal portion of two bypass prostheses.
64. The system of claim 1 further comprising at least one marker positioned on the bypass prosthesis, the extension prosthesis, or combinations thereof.
65. The system of claim 64 wherein at least one marker is positioned on a proximal portion of the bypass prosthesis.
66. The system of claim 64 wherein at least one marker is positioned on a distal portion of the bypass prosthesis.
67. The system of claim 66 wherein at least one marker is positioned on a distal portion of the bypass prosthesis.
68. The system of claim 64 wherein at least one marker is positioned on a proximal portion of the extension prosthesis.
69. The system of claim 64 wherein at least one marker is positioned on a distal portion of the extension prosthesis.
70. The system of claim 69 wherein at least one marker is positioned on a distal portion of the extension prosthesis.
71. The system of claim 55 wherein at least one marker is positioned on a proximal portion of the first prosthesis.
72. The system of claim 55 wherein at least one marker is positioned on a distal portion of the first prosthesis.
73. The system of claim 1 wherein the aneurysm is located in an artery.
74. The system of claim 73 wherein the artery is an abdominal aorta.
75. The system of claim 73 wherein the bypass prosthesis is adapted to engage an abdominal aorta.
76. The system of claim 73 wherein a proximal portion of the extension prosthesis is adapted to engage the proximal portion of the distal end of the bypass prosthesis.
77. The system of claim 73 wherein a distal portion of the extension prosthesis is adapted to engage an iliac artery.
78. The system of claim 76 wherein a distal portion of the extension prosthesis is adapted to engage an iliac artery.
79. A system for establishing a fluid flow path from one portion of an artery into a branched portion of a downstream portion of an arterial network comprising a bypass prosthesis communicating with an upstream segment of an artery, said bypass prosthesis having a distal end; a first extension prosthesis configured to engage a portion of the distal end of the bypass prosthesis, said first extension extending into a first branched portion of a downstream artery; and a second extension prosthesis configured to engage a portion of the distal end of the bypass prosthesis, said second extension extending into a second branched portion of a downstream artery.
80. A method for bypassing a portion of an artery between a single proximal portion and a bifurcated distal portion comprising providing a bypass prosthesis, and sealingly engaging at least one extension prosthesis in a distal portion of said bypass prosthesis, said extension prosthesis extending into a bifurcated portion of said artery.
81. A delivery method for positioning a prosthesis in an iliac artery comprising passing a guidewire through a bypass prosthesis proximally to distally and into the internal iliac artery; delivering an extension prosthesis over said guidewire distally to proximally, and into the internal iliac artery; and deploying the extension prosthesis with a trailing end of the extension prosthesis matingly engaging a distal portion of the bypass prosthesis.
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