Modular graft assembly

• US 6,106,549 A
• Filed: 05/07/1999
• Issued: 08/22/2000
• Est. Priority Date: 10/12/1997
• Status: Expired due to Term

• Current Assignee: Syde A. Taheri
• Original Assignee: Syde A. Taheri
• Inventors: Taheri, Syde A.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/307,314
• Time in Patent Office: 473 Days
• Field of Search: 623/1.23, 623/1.11, 623/1.13, 606/108, 606/158, 606/194, 606/195, 606/198, 606/200
• US Class Current: 623/1.23
• 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

A method for positioning a graft within a vasculature is described. The method comprises positioning a guide wire extending from an entry opening past a treatment zone to an exit opening. The guide wire has an attachment portion that is connected to a first string extending from a distal end of the graft. The guide wire is manipulated to move the string through the vasculature until the first string extends out the exit opening with a second string connected to the proximal end of the graft extending out the entry opening. The first string is disconnected from the guide wire and the first and second strings are manipulated to position the graft at the treatment zone.

Claims

1. A method for positioning a graft within a vasculature, comprising the steps of:

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

c) providing at least one string extending from each of the proximal and distal graft ends;

d) connecting the at least one string extending from the distal graft end 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 of the guide wire;

e) manipulating the guide wire 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;

f) disconnecting the at least one string extending from the distal graft end from the first attachment portion of the guide wire to remove the guide wire from connection with the graft; and

g) positioning the graft 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 method of claim 1 further including:

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

b) mounting an expandable stent 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; and

c) expanding the balloon to cause the expandable stent to secure the graft to an inner wall of the vasculature.

3. The method of claim 2 including providing the catheter having 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.

4. The method of claim 2 including manipulating the expandable balloon to secure the graft to the inner wall of the vasculature on either side of the treatment zone.

5. The method 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.

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

7. The method of claim 6 wherein the second attachment portions provided at the proximal and distal graft ends are comprised of one or more graft loops.

8. The method of claim 6 including connecting at least one string 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.

9. The method of claim 6 wherein the second attachment portions provided at the proximal and distal graft ends are graft loops and including connecting the at least one string to the second attachment portion by moving the string through the loop and doubling the string back upon itself.

10. The method 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.

11. The method of claim 1 including verifying the location of the graft in the vasculature using an image amplifier.

12. The method of claim 1 including positioning a restraining device on and about the graft as the graft is positioned to span the treatment zone.

13. The method of claim 12 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.

14. The method of claim 1 including positioning a restraining device 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.

15. The method of claim 14 wherein the end cap is cone shaped.

16. The method of claim 14 wherein the end cap is comprised of a cap ring.

17. The method of claim 1 including providing 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.

18. The method of claim 1 including providing an entry sheath for maintaining the patency of the entry opening and the exit opening.

19. The method of claim 1 including providing the guide wire comprised of a middle portion, and wherein the first attachment portion is comprised of a ring located at the middle portion of the guide wire.

20. The method of claim 1 including providing the first attachment portion as a ring positioned at the distal end of the guide wire.

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

22. A method for repairing an aneurysm within a vasculature, comprising the steps of:

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

c) providing at least one string extending from each of the proximal and distal ends of the engrafting device;

d) connecting the at least one string extending from the distal end of the engrafting device 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 of the guide wire;

e) manipulating the guide wire 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;

f) disconnecting the at least one string extending from the distal end of the engrafting device from the first attachment portion of the guide wire to remove the guide wire from connection with the engrafting device; and

g) positioning the engrafting device 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. A method for positioning a stent within a vasculature, comprising the steps of:

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

c) providing at least one string extending from each of the proximal and distal ends of the stent;

d) connecting the at least one string extending from the distal end of the stent 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 of the guide wire;

e) manipulating the guide wire 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;

f) disconnecting the at least one string extending from the distal end of the stent from the first attachment portion of the guide wire to remove the guide wire from connection with the stent; and

g) positioning the stent 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.