Stent graft delivery system and methods of use

• US 5,824,055 A
• Filed: 03/25/1997
• Issued: 10/20/1998
• Est. Priority Date: 03/25/1997
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Spiridigliozzi, John, Khosravi, Farhad, Abolfathi, Amir, Ross, Michael R.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/824,012
• Time in Patent Office: 574 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A stent-graft delivery system and methods for use are provided for use in treating aneurysms occurring in single and bifurcated lumen hollow-body organs or vessels and for treating arterio-venous fistulas. A graft delivery component provides a clinician with complete control over the location of a graft at any time prior to implantation of stents, even when the graft is deployed from its introducer catheter. The graft delivery component includes a plurality of radially expandable fingers that releasably engage the graft, while the stent delivery component includes a small diameter introducer catheter and permits a wide range of conventional stent designs to be used to permanently fix the graft in position.

Claims

1. A method of implanting a graft in a hollow-body organ or vessel, the method comprising steps of:

providing a graft, an introducer catheter and a graft delivery component having a plurality of fingers, each of the fingers including a retention wire that releasably engages the graft, the fingers and the graft retained in a contracted state by the introducer catheter;

inserting the graft delivery component and introducer catheter transluminally to deliver the graft to a desired position in the hollow-body organ or vessel; and

retracting the introducer catheter to allow the fingers to resiliently deploy to an expanded state in which the graft is held in apposition to an interior wall of the hollow-body vessel or organ.

2. The method as defined in claim 1 further comprising steps of:

providing a stent delivery component for delivering a stent;

inserting the stent delivery component transluminally to a position adjacent the graft; and

while retaining the graft in apposition to the interior wall of the hollow-body organ or vessel with the graft delivery component, deploying a first stent from the stent delivery component to affix a first end of the graft to the interior wall of the hollow-body organ or vessel.

3. The method as defined in claim 2 further comprising steps of:

while retaining the graft in apposition to the interior wall of the hollow-body organ or vessel with the graft delivery component, deploying a second stent from the stent delivery component to affix a second end of the graft to the interior wall of the hollow-body organ or vessel.

4. The method as defined in claim 1 further comprising a step of retracting the retention wires to release the graft from the graft delivery component.

5. The method as defined in claim 2 wherein the hollow-body organ is an abdominal aorta that communicates with first and second iliac arteries and a brachial/carotid artery, the step of inserting the graft delivery component and introducer catheter transluminally to deliver the graft comprising inserting the graft delivery component and introducer catheter through a first iliac artery, and the step of inserting the stent delivery component transluminally to a position adjacent the graft comprises inserting the stent delivery component through one of the arteries in a group consisting of the first iliac artery, the second iliac artery and the brachial/carotid artery.

6. The method as defined in claim 1 wherein the graft delivery component further comprises a support tube, the step of inserting the graft delivery component and introducer catheter transluminally to deliver the graft to a desired position further comprising a step of moving the support tube in proximal and distal directions to adjust positioning of the graft.

7. The method as defined in claim 1 further comprising a step, after the step of moving the graft to a desired position, of retracting the graft within the introducer catheter to retrieve the graft.

8. The method as defined in claim 2 wherein the stent delivery component comprises an outer sheath and a balloon member, the stent disposed in a contracted state within the outer sheath, the step of deploying a first stent from the stent delivery component further comprising steps of:

disposing the stent delivery component so that the first stent, when deployed, partially overlaps the first end of the graft;

while retaining the stent delivery component in a desired position, retracting the outer sheath to permit the first stent to be at least partially deployed; and

inserting the balloon member within the first stent and inflating the balloon member to lock the first stent in place.

9. The method as defined in claim 1 wherein the hollow-body organ or vessel includes a bifurcation having first and second branches and the graft is a bifurcated graft having a common lumen and first and second legs, the common lumen and first leg of the graft engaged with the graft delivery component, the method further comprising, prior to the step of inserting the graft delivery component and introducer catheter transluminally, steps of:

providing a snare catheter and guide catheter carrying a guidewire;

inserting the guide catheter and guidewire transluminally into the hollow-body organ or vessel through the first branch, the guidewire extending from the guide catheter;

manipulating the guide catheter to direct an end of the guidewire toward the second branch;

transluminally inserting the snare catheter through the second branch;

capturing the end of the guidewire with the snare catheter;

pulling the end of the guidewire through the second branch, so that the guidewire spans a bifurcation between the first branch and the second branch; and

coupling the guidewire to the second leg of the graft.

10. The method as defined in claim 1 wherein the hollow-body organ or vessel includes a bifurcation having first and second branches and the graft is a bifurcated graft having a common lumen and first and second legs, the common lumen and first leg of the graft engaged with the graft delivery component, the method further comprising, after the step of retracting the introducer catheter, steps of:

providing a snare catheter, a positioning catheter, and guide catheter carrying a guidewire;

inserting the guide catheter and guidewire through the introducer catheter, the first leg, and into the common lumen of the graft;

manipulating the guide catheter to direct an end of the guidewire through the second leg;

transluminally inserting the snare catheter through the second branch;

capturing the end of the guidewire with the snare catheter;

pulling the end of the guidewire through the second branch, so that the guidewire spans a bifurcation between the first branch and the second branch;

inserting the positioning catheter through the second branch along the guidewire; and

manipulating the positioning catheter to engage and position the second leg of the graft in the second branch.

11. The method as defined in claim 1 wherein the hollow-body organ or vessel includes a bifurcation having first and second branches and the graft is a bifurcated graft having a common lumen and first and second legs, the common lumen and first leg of the graft engaged with the graft delivery component, the graft delivery component releasably holding a guidewire that extends into the second leg, the method further comprising, after the step of retracting the introducer catheter, steps of:

providing a snare catheter and a positioning catheter;

transluminally inserting the snare catheter through the second branch;

capturing the end of the guidewire with the snare catheter;

pulling the guidewire with the snare catheter to free the guidewire from the graft delivery component;

pulling the end of the guidewire through the second branch, so that the guidewire spans a bifurcation between the first branch and the second branch;

inserting the positioning catheter through the second branch along the guidewire; and

manipulating the positioning catheter to engage and position the second leg of the graft in the second branch.

12. A graft delivery system for implanting a tubular graft in a hollow-body organ or vessel comprising:

a support tube having a circumference;

a plurality of resilient fingers disposed about the circumference of the support tube, each of the resilient fingers having a tip, the resilient fingers movable between a compressed state in which the resilient fingers are compressively stressed so that the tips are disposed adjacent to the support tube and a deployed state in which the resilient fingers are in an unstressed state and the tips are deployed radially outward from support tube, each of the resilient fingers including retention means for releasably engaging a tubular graft; and

an introducer catheter having a passageway, the introducer catheter being movable from a first position in which the plurality of resilient fingers are disposed within the passageway so that the introducer catheter compresses the resilient fingers to the compressed state and a second position in which the introducer catheter is retracted so that the plurality of resilient fingers are in the deployed state.

13. The graft delivery system as defined in claim 12 wherein the plurality of resilient fingers are arranged in proximal and distal groups on the support tube.

14. The graft delivery system as defined in claim 13 wherein each of the proximal and distal groups comprises three resilient fingers.

15. The graft delivery system as defined in claim 12 wherein the plurality of resilient fingers are disposed equidistant apart around the circumference of the support tube.

16. The graft delivery system as defined in claim 12 wherein each of the resilient fingers includes a portion defining a lumen, the retention means comprising:

an aperture disposed in a lateral face of each finger adjacent the tip, the aperture communicating with the lumen; and

a retention wire having a distal end, the retention wire disposed in the lumen and movable from a first position in which the distal end is disposed distally of the aperture and a second position in which the distal end is disposed proximally of the aperture, the retention wire releasably engaging a portion of the graft extending into the aperture in the first position.

17. The graft delivery system as defined in claim 16 further comprising means manipulable by a user to retract the retention wires to the second position.

18. The graft delivery system as defined in claim 12 wherein the graft is a bifurcated graft having a common lumen and first and second legs, the support tube further comprising means for releasably engaging a guidewire so that the guidewire passes through the first leg and into the common lumen, and extends into the second leg.

19. The graft delivery system as defined in claim 12 further comprising a guide catheter having a steerable distal end.

20. The graft delivery system as defined in claim 12 further comprising a snare catheter including a snare loop.

21. The graft delivery system as defined in claim 12 further comprising a positioning catheter, the positioning catheter comprising:

a support tube;

a plurality of resiliently outwardly expanding fingers; and

a sheath slidably disposed on the support tube for moving the plurality of resiliently outwardly expanding fingers from a transit position to a deployed position.

22. A stent-graft delivery system comprising:

a graft delivery component including;

a plurality of resilient fingers, each of the resilient fingers having a tip, the resilient fingers movable between a compressed state in which the resilient fingers are compressively stressed so that the tips are disposed adjacent one another and a deployed state in which the resilient fingers are in an unstressed state and the tips are deployed radially outward from one another;

each of the resilient fingers including retention means for releasably engaging a tubular graft; and

an introducer catheter movable from a first position in which the plurality of resilient fingers are retained in the compressed state and a second position in which the introducer catheter is retracted so that the plurality of resilient fingers are in the deployed state; and

a stent delivery component, the stent delivery component carrying a stent for affixing the graft to a wall of a hollow-body organ or vessel.

23. The stent-graft delivery system as defined in claim 22 wherein the plurality of resilient fingers are arranged in proximal and distal groups.

24. The stent-graft delivery system as defined in claim 23 wherein each of the proximal and distal groups comprises three resilient fingers spaced equidistant apart.

25. The stent-graft delivery system as defined in claim 22 wherein each one of the resilient fingers includes a portion defining a lumen, the retention means comprising:

an aperture disposed in a lateral face of each finger adjacent the tip, the aperture communicating with the lumen;

a retention wire having a distal end, the retention wire disposed in the lumen and movable from a first position in which the distal end is disposed distally of the aperture and a second position in which the distal end is disposed proximally of the aperture, the retention wire releasably engaging a portion of the graft extending into the aperture in the first position.

26. The stent-graft delivery system as defined in claim 22 wherein the stent delivery component comprises:

an outer sheath having a transit position for transluminal insertion and a retracted position;

a core member disposed within the outer sheath, the core member carrying a nose cone at a distal end and a retaining member disposed on the core member spaced apart from the nose cone, the core member configured to accept a stent in a contracted state between the nose cone and the retaining member, the outer sheath retaining the stent in the contracted state when in the transit position.

27. The stent-graft system as defined in claim 26 wherein the stent delivery component further comprises a balloon member, wherein the core member includes a lumen for inflating the balloon member.

28. The graft delivery system as defined in claim 22 wherein the graft is a bifurcated graft having a common lumen and first and second legs, the support tube further comprising:

means for releasably engaging a guidewire so that the guidewire passes through the first leg and into the common lumen, and extends into the second leg; and

a snare catheter including a snare loop for engaging the guidewire extending into the second leg.

29. The graft delivery system as defined in claim 22 further comprising:

a guide catheter having a steerable distal end; and

a snare catheter including a snare loop.

30. The graft delivery system as defined in claim 22 further comprising a positioning catheter, the positioning catheter comprising:

a support tube;

a plurality of resiliently outwardly expanding fingers; and

a sheath slidably disposed on the support tube for moving the plurality of resiliently outwardly expanding fingers from a transit position to a deployed position.