Endovascular apparatus

• US 5,871,537 A
• Filed: 02/13/1996
• Issued: 02/16/1999
• Est. Priority Date: 02/13/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Holman, Thomas J., Buscemi, Paul J., Donabedian, David H., Thometz, Darlene A., Bilge, Fertac
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/600,834
• Time in Patent Office: 1,099 Days
• Field of Search: 623/1, 623/11, 623/12, 604/96, 604/97, 604/104, 604/106, 604/107, 606/191, 606/194, 606/195, 606/198
• US Class Current: 623/1.23
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• 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 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Percutaneous treatment of aortic aneurysms and like vascular anomalies by an apparatus and method wherein the apparatus is delivered via catheter and comprises a sleeve with at least one peripheral conduit which is caused to assume an expanded, rigid configuration by the introduction of a chemical or mechanical hardening means, whereby the sleeve is caused to assume an open cylindrical configuration for fluid flow therethrough.

Claims

1. A vascular graft apparatus comprising:

a) a flexible, tubular sleeve having at least one axis therethrough and further comprising a first end, at least one opposite end located opposite said first end, and an exterior portion;

b) at least one exterior conduit surrounding the exterior portion of said sleeve, each said at least one exterior conduit having an inlet port, the at least one exterior conduit being adjacent to the exterior portion of the sleeve, but not coextensive with the sleeve;

c) delivery means removably connected to the at least one exterior conduit at its inlet port, said delivery means being in association with a hardening means;

whereby when the sleeve is delivered to an implant site at an area of a vessel having an aneurysm such that the apparatus is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one exterior conduit to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

2. The apparatus of claim 1 further comprising at least one additional conduit surrounding the sleeve, said at least one additional conduit being located at the first end of the sleeve.

11. The apparatus of claim 1 further comprising a plurality of exterior conduits surrounding the sleeve, said exterior conduits being located between the first end and an opposite end of the sleeve.

12. The apparatus of claim 1 further comprising an enclosure over the exterior portion of the sleeve between the first end and an opposite end thereof.

3. A vascular graft apparatus comprising:

a) a flexible, tubular sleeve having at least one axis therethrough and further comprising a first end, at least one opposite end located opposite said first end, and an exterior portion;

b) at lease one exterior conduit surrounding said sleeve, each said at least one exterior conduit having an inlet port;

c) delivery means removably connected to the at least one exterior conduit at its inlet port, said delivery means being in association with a hardening means, said hardening means comprising an activatable hardening material selected from the group consisting of one-part polymer systems, two-part polymer systems and self-expanding monomers which, upon polymerization, fill said at least one exterior conduit, the apparatus further comprising a source of hardening material in association with the delivery means;

whereby when the sleeve is delivered to an implant site at an area of a vessel having an aneurysm such that the apparatus is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one exterior conduit to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

4. The apparatus of claim 3 herein the hardening means further comprises at least one receptacle containing the activatable hardening material.

7. The apparatus of claim 3 wherein each said at least one exterior conduit has an outlet port, whereby when the sleeve is delivered to an area of an artery having an aneurysm such that the apparatus is positioned at the aneurysm and hardening means is introduced, each said at least one exterior conduit is substantially filled with hardening means and is thereby caused to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

8. The apparatus of claim 7 comprising at least two exterior conduits surrounding the sleeve, one of said at least two exterior conduits being located proximal to the first end of the sleeve, and a second of said at least two conduits being located between the first end and an opposite end of the sleeve.

5. A vascular graft apparatus comprising:

a) a flexible, tubular sleeve having at least one axis therethrough and further comprising a first end, at least one opposite end located opposite said first end, and an exterior portion;

b) at least one exterior conduit surrounding said sleeve, each said at least one exterior conduit having an inlet port;

c) delivery means removably connected to the at least one exterior conduit at its inlet port, d) hardening means in association with the delivery means, said hardening means comprising an activatable hardening material selected from the group consisting of one-part polymer systems, two-part polymer systems and self-expanding monomers, said hardening means further comprising at least one receptacle containing the activatable hardening material, the apparatus further comprising a plurality of microspheres wherein the activatable hardening material is carried, said plurality of microspheres being located within said at least one receptacle and further being constructed and arranged to release the activatable hardening material upon disruption of the plurality of microspheres, thereby allowing the activatable hardening material to harden, said apparatus further comprising a source of hardening material in association with the delivery means;

whereby when the sleeve is delivered to an implant site at an area of a vessel having an aneurysm such that the apparatus is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one exterior conduit to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

6. A vascular graft apparatus comprising:

a) a flexible, tubular sleeve having at least one axis therethrough and further comprising a first end, at least one opposite end located opposite said first end, and an exterior portion;

b) at least one exterior conduit surrounding said sleeve, each said at least one exterior conduit having an inlet port;

c) delivery means removably connected to the at least one exterior conduit at its inlet port,

d) hardening means in association with the delivery means, said hardening means comprising an activatable hardening material selected from the group consisting of one-part polymer systems, two-part polymer systems and self-expanding monomers, said hardening means further comprising at least one receptacle containing the activatable hardening material, the apparatus further comprising a plurality of microspheres and wherein the activatable hardening material comprises a first component and a second component, said first component and second component being isolated from each other by said plurality of microspheres and carried in said plurality of microspheres, said plurality of microspheres being constructed and arranged to release said first component and second component upon disruption of the plurality of microspheres, thereby allowing the first component and second component to react and harden, said apparatus further comprising a source of hardening material in association with the delivery means;

whereby when the sleeve is delivered to an implant site at an area of a vessel having an aneurysm such that the apparatus is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one exterior conduit to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

9. A vascular graft apparatus comprising:

a) a flexible tubular sleeve having at least one axis therethrough and further comprising a first end, at least one second end, an interior portion and an exterior portion;

b) an exterior conduit surrounding the exterior portion of the sleeve at the first end and each said at least one second end, each said exterior conduit having at least one entrance port, said exterior conduit being adjacent to the exterior portion of sleeve, but not coextensive with the sleeve; and

c) introduction means in communication with the at least one entrance port of each exterior conduit for introduction of a hardening means;

whereby when the sleeve is delivered to an area of an artery having an aneurysm such that the sleeve is positioned at the aneurysm, and hardening means is introduced, each said exterior conduit is caused to assume an expanded, rigid configuration which fits securely into the artery and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.

10. A vascular graft apparatus comprising:

a) a flexible, tubular sleeve having at least one axis therethrough and further comprising a first end, at least two opposite ends located opposite said first end, and an exterior portion;

b) at least one exterior conduit surrounding the exterior portion of said sleeve, each said at least one exterior conduit having an inlet port, said at least one exterior conduit being adjacent to the exterior portion of the sleeve, but not coextensive with the sleeve;

c) delivery means removably connected to the at least one exterior conduit at its inlet port,said delivery means being in association with a hardening means;

whereby when the sleeve is delivered to an implant site at an area of a vessel having an aneurysm such that the apparatus is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one exterior conduit to assume an expanded, rigid configuration which fits securely into the vessel and is anchored thereto by pressure, causing the sleeve to be supported in an open condition for fluid flow therethrough.