Modular graft assembly

• US 5,948,017 A
• Filed: 10/12/1997
• Issued: 09/07/1999
• Est. Priority Date: 10/12/1997
• Status: Expired due to Fees

• Current Assignee: Taheri Enterprises, LLC
• Original Assignee: Syde A. Taheri
• Inventors: Taheri, Syde A.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US08/946,748
• Time in Patent Office: 695 Days
• Field of Search: 623/1, 623/2, 623/11, 623/12, 606/194, 606/195, 606/198, 606/200
• US Class Current: 623/1.14
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

An apparatus for engrafting a blood vessel comprising: a plurality of strings, a tubular graft having a central lumen, wherein the plurality of strings are removably attached to the tubular graft, the graft is removably positioned at least partially within a restraining means, such as a sheath introducer, a guide wire with an attachment means for attachment of the plurality of strings, one or more stents for deployment within the graft, and a means for deploying the stents within the graft.

Claims

1. An assembly for positioning a graft within a vasculature, which comprises:

a) a guide wire having proximal and distal ends and a first attachment portions wherein the guide wire has a length between the ends sufficient to extend from an entry opening into the vasculature, past a treatment zone and out an exit opening from the vasculature;

b) a graft having a central lumen extending to proximal and distal graft ends; and

c) at least one string extending from each of the proximal and distal graft ends, wherein the at least one string extending from the distal graft end is connectable to the first attachment portion of the guide wire so that when the guide wire extends through the vasculature with the proximal end thereof extending out the entry opening and with the first attachment portion accessible from outside the vasculature adjacent to the entry opening, the at least one string extending from the distal graft end is connectable to the first attachment portion so that the guide wire is manipulatable to move the graft through the vasculature until the at least one string extending from the distal graft end and connected to the first attachment portion of the guide wire extends out the exit opening and the at least one string extending from the proximal graft end extends out the entry opening, and wherein the at least one string extending from the distal draft end is disconnectable from the first attachment portion of the guide wire to remove the guide wire from connection with the graft so that the graft is positionable to span the treatment zone by manipulation of the at least one string connected to each of the proximal and distal graft ends.

2. The assembly of claim 1 further including:

(a) a catheter having proximal and distal ends and an expandable balloon provided at a distal portion of the catheter; and

(b) an expandable stent mounted on the expandable balloon of the catheter, wherein the catheter is movable along the vasculature from either the entry opening or the exit opening to a position at least partially inside the lumen of the graft so that when the expandable balloon is expanded, the expandable stent secures the graft to an inner wall of the vasculature.

3. The assembly of claim 2 wherein the expandable catheter is manipulatable to secure the graft to the inner wall of the vasculature on either side of the treatment zone.

4. The assembly of claim 2 wherein the graft is initially provided in a radially reduced state until such time as the stent secures the graft to the inner wall of the vasculature.

5. The assembly of claim 1 wherein the graft has at least one second attachment portion provided at each of the proximal and distal ends thereof.

6. The assembly of claim 5 wherein at least one string is connectable to the second attachment portion at both the proximal and distal graft ends to provide at least one string extending from the proximal and distal graft ends.

7. The assembly of claim 5 wherein the second attachment portions provided at the proximal and distal graft ends are graft loops-and wherein the at least one string is connectable to the second attachment portion by moving the string through the loop and doubling the string back upon itself.

8. The assembly of claim 1 wherein when the guide wire extends through the vasculature with the proximal end thereof extending out the entry opening and with the first attachment portion accessible from outside the vasculature adjacent to the entry opening, the distal end of the guide wire extends out the exit opening from the vasculature.

9. The assembly of claim 1 further including a restraining device positioned on and about the craft as the graft is positionable to span the treatment zone.

10. The assembly of claim 9 wherein the restraining device is a cylindrically-shaped sheath introducer provided along and about the graft as the graft is positionable to span the treatment zone.

11. The assembly of claim 1 wherein the location of the graft in the vasculature is verifiable by an image amplifier.

12. The assembly of claim 1 further including a restraining device positioned on the at least one string extending from the distal end of the graft to the first attachment portion of the guide wire, wherein the restraining device is an end cap provided adjacent to the distal end of the graft.

13. The assembly of claim 12 wherein the end cap is cone shaped.

14. The assembly of claim 12 wherein the end cap is comprised of a cap ring.

15. The assembly of claim 1 wherein the graft further comprises a plurality of second attachment portions at both the proximal and distal graft ends to provide a plurality of strings extending from both the proximal and distal graft ends.

16. The assembly of claim 11 further comprising a catheter and a plunger movably positioned within a lumen of the catheter for securing the graft to the inner wall of the vasculature with the stent moved into position by the catheter.

17. The assembly of claim 1 further comprising an entry sheath for maintaining the patency of the entry opening and the exit opening.

18. The assembly of claim 1 wherein the guide wire is comprised of a middle portion, and the first attachment portion is comprised of a ring located at the middle portion of the guide wire.

19. The assembly of claim 1 wherein the first attachment portion is a ring positioned at the distal end of the guide wire.

20. The assembly of claim 1 wherein the guide wire is less than 0.38 millimeters in diameter.

21. The assembly of claim 5 wherein the second attachment portions provided at the proximal and distal graft ends are comprised of one or more graft loops.

22. An assembly for repairing an aneurysm within a vasculature, which comprises:

a) a guide wire having proximal and distal ends and a first attachment portion, wherein the guide wire has a length between the ends sufficient to extend from an entry opening into the vasculature, past a treatment zone and out an exit opening from the vasculature;

b) an engrafting device having a central lumen extending to proximal and distal ends thereof; and

c) at least one string extending from each of the proximal and distal ends of the engrafting device, wherein the at least one string extending from the distal end of the engrafting device is connectable to the first attachment portion of the guide wire so that when the guide wire extends through the vasculature with the proximal end thereof extending out the entry opening and with the first attachment portion accessible from outside the vasculature adjacent to the entry opening, the at least one string extending from the distal end of the engrafting device is connectable to the first attachment portion so that the guide wire is manipulable to move the engrafting device through the vasculature until the at least one string extending from the distal end of the engrafting device and connected to the first attachment portion of the guide wire extends out the exit opening and the at least one string extending from the proximal end of the engrafting device extends out the entry opening, and wherein the at least one string extending from the distal end of the engrafting device is disconnectable from the first attachment portion of the guide wire to remove the guide wire from connection with the engrafting device so that the engrafting device is positionable to span the aneurysm by manipulation of the at least one sting connected to each of the proximal and distal ends of the engrafting device.

23. An assembly for positioning a stent within a vasculature, which comprises:

a) a guide wire having proximal and distal ends and a first attachment portion, wherein the guide wire has a length between the ends sufficient to extend from an entry opening into the vasculature, past a treatment zone and out an exit opening from the vasculature;

b) a stent having a central lumen extending to proximal and distal ends thereof; and

c) at least one string extending from each of the proximal and distal ends of the stent, wherein the at least one string extending from the distal end of the stent is connectable to the first attachment portion of the guide wire so that when the guide wire extends through the vasculature with the proximal end thereof extending out the entry opening and with the first attachment portion accessible from outside the vasculature adjacent to the entry opening, the at least one string extending from the distal end of the stent is connectable to the first attachment portion so that the guide wire is manipulable to move the stent through the vasculature until the at least one string extending from the distal end of the stent and connected to the first attachment portion of the guide wire extends out the exit opening and the at least one string extending from the proximal end of the stent extends out the entry opening, and wherein the at least one string extending from the distal end of the stent is disconnectable from the first attachment portion of the guide wire to remove the guide wire from connection with the stent so that the stent is positionable in the vasculature at a desired location by manipulation of the at least one string connected to each of the proximal and distal ends of the stent.