Endovascular apparatus

• US 20030220684A1
• Filed: 06/03/2003
• Published: 11/27/2003
• Est. Priority Date: 02/13/1996
• Status: Abandoned Application

• Current Assignee: Scimed Life Systems Incorporated (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
• Application Number:
  US10/454,896
• Publication Number:
  US 20030220684A1
• Time in Patent Office: Days
• US Class Current: 623/1.21
• 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 device comprising:

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

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

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

whereby when the device is delivered to an area of a vessel having an aneurysm such that the device is positioned at the aneurysm and the hardening means is delivered, the hardening means causes the at least one peripheral 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 device of claim 1 further comprising at least one additional conduit surrounding the sleeve, said additional conduit being located at the first end of the sleeve.

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

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

5. The apparatus of claim 1 wherein the hardening means comprises an activatable hardening material selected from the group consisting of one-part polymer systems, two-part polymer systems and self-expanding monomers, the apparatus further comprising a source of hardening material in association with the delivery means.

6. The apparatus of claim 5 wherein the hardening means further comprises at least one receptacle containing the activatable hardening material.

7. The apparatus of claim 6 further comprising a plurality of microspheres wherein the activatable hardening material is carried, said microspheres being located within the receptacle and further being constructed and arranged to release the activatable hardening material upon disruption, thereby allowing the activatable hardening material to harden.

8. The apparatus of claim 6 wherein the activatable hardening material comprises a first component and a second component isolated from each other by and carried in said microspheres, said microspheres being constructed and arranged to release said first and second components upon disruption, thereby allowing the components to react and harden.

9. The device of claim 1 wherein each said at least one peripheral conduit has an outlet port, whereby when the device is delivered to an area of an artery having an aneurysm such that the device is positioned at the aneurysm and hardening means is introduced, the peripheral conduits are substantially filled with hardening means and are 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.

10. The device of claim 9 further comprising at least one additional conduit surrounding the sleeve, said additional conduit being located between the first end and an opposite end of the sleeve.

11. A vascular graft device comprising:

a) a flexible tubular sleeve configuration 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) a peripheral conduit surrounding each of said ends, each peripheral conduit having at least one entrance port; and

c) introduction means in communication with the port of each end tube for introduction of a hardening means;

whereby when the device 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, the peripheral conduits are 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.

12. An apparatus for repairing an arterial aneurysm, the apparatus comprising:

a) a catheter delivery means; and

b) an arterial graft device comprising;

i) a flexible, tubular sleeve configuration having at least one axis therethrough and further comprising a first end, at least one opposite end, and exterior and interior portions;

ii) a peripheral conduit surrounding the sleeve and having at least one port;

iii) introduction means associated with the catheter delivery means and being in communication with each at least one port; and

iv) hardening means delivered through said introduction means for causing the arterial graft device to assume a rigid cylindrical configuration;

whereby when the apparatus 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, the conduits are caused to assume a rigid, expanded 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, and causing the aneurysm to be repaired.

13. The apparatus of claim 12 wherein the sleeve is made of a nonbiodegradable, biocompatible polymeric material.

14. The apparatus of claim 13 wherein the polymeric material is selected from the group consisting of thermosetting polymers, thermoplastic polymers, thermoplastic elastomers, elastomers, composites, pseudo-thermoplastics, carbohydrates, proteins, and mixtures thereof.

15. The apparatus of claim 12 wherein the sleeve is made of a material selected from the group consisting of Dacron®

or PTFE.

16. The apparatus of claim 12 wherein the sleeve is made of a woven or braided material.

17. The apparatus of claim 12 wherein the sleeve is made of a material selected from the group consisting of polyamides, nylon 6, nylon 6,6, polyesters, PET, polyethers, fluorinated polymers, polytetrafluoroethylene, biodegradable or nonbiodegradable fibers derived from natural sources such as carbohydrates, collagens, and proteins, and mixtures thereof.

18. The apparatus of claim 17 wherein the sleeve is biodegradable.

19. The apparatus of claim 12 wherein:

a) the hardening means comprises at least one wire for insertion into and extension through the introduction means into a peripheral conduit.

20. The apparatus of claim 19 wherein the wire is made of a material selected from the group consisting of stainless steel, spring steel, memory shape metals, and metal alloys.

21. The apparatus of claim 20 wherein the wire is made of nitinol.

22. The apparatus of claim 20 wherein the wire is made of titanium.

23. The apparatus of claim 12 wherein the peripheral conduit has an inlet port and an exhaust port and wherein the hardening means is a polymeric material.

24. The apparatus of claim 23 wherein the polymeric material is introduced through the introduction means via an external source.

25. The apparatus of claim 23 wherein the external source is a syringe.

26. The apparatus of claim 23 wherein the external source is a catheter.

27. The apparatus of claim 13 wherein the hardening means comprises an activatable hardening material selected from the group consisting of one-part polymer systems, two-part polymer systems and self-expanding monomers.

28. The apparatus of claim 27 wherein the hardening means further comprises a plurality of microspheres wherein the activatable hardening material is carried, said microspheres being constructed and arranged to release the activatable hardening material upon disruption, thereby allowing the activatable hardening material to harden.

29. The apparatus of claim 28 wherein the activatable hardening material comprises a first component and a second component isolated from each other by and carried in said microspheres, said microspheres being constructed and arranged to release said first and second components upon disruption, thereby allowing the components to react and harden.