Bifurcated multicapsule intraluminal grafting system and method

• US 5,769,885 A
• Filed: 08/16/1996
• Issued: 06/23/1998
• Est. Priority Date: 04/11/1991
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Baker, Steve G., Williams, Richard S., Johansson, Peter K., Piplani, Alec A., Quiachon, Dinah B.
• Primary Examiner(s): Hafer, Robert S.
• Assistant Examiner(s): FOSSUM, LAURA J
• Application Number:
  US08/698,787
• Time in Patent Office: 676 Days
• Field of Search: 623/1, 623/12, 606/194, 606/195, 606/198
• US Class Current: 128/898
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An intraluminal grafting system having a balloon catheter assembly, a capsule catheter assembly and capsule jacket assembly is used for deploying in the vessel of an animal body a bifurcated graft having a plurality of attachment systems. The deployment catheters contain an ipsilateral capsule assembly, a contralateral capsule assembly and a distal capsule assembly, wherein the attachment systems of the bifurcated graft are disposed within the three capsule assemblies. A removable sheath of the capsule jacket assembly covers the bifurcated graft and capsule assemblies to provide a smooth transition along the length of the deployment catheters. The bifurcated graft is comprised of a main tubular member and two tubular legs, having attachment systems with wall engaging members secured to the superior end of the main tubular member and the inferior ends of the tubular legs. An inflatable membrane configured on the balloon catheter is used to firmly implant the attachment systems within the vessel. The bifurcated graft and attachment systems are configured to remain in the vessel after the deployment catheters are withdrawn. The method of use of the present intraluminal grafting system is also disclosed, for example, for deploying a bifurcated graft proximate the abdominal aortic bifurcation.

Claims

1. A method for securing a bifurcated graft in a corporeal lumen, the bifurcated graft having a superior end, an ipsilateral inferior end and a contralateral inferior end, the bifurcated graft further having a superior attachment system disposed proximate the superior end, an ipsilateral attachment system disposed proximate the ipsilateral inferior end and a contralateral attachment system disposed proximate the contralateral inferior end, said method comprising the steps of:

providing a delivery catheter assembly having three distinct capsule means including distal capsule means for containing the superior attachment system of the bifurcated graft, ipsilateral capsule means for containing the ipsilateral attachment system and contralateral capsule means for containing the ipsilateral attachment system;

positioning the delivery catheter assembly and the bifurcated graft at a desired location within a corporeal lumen;

moving the distal capsule means distally with respect to the superior end of the bifurcated graft to expose the superior attachment system;

withdrawing the contralateral capsule means from the contralateral inferior end of the bifurcated graft to expose the contralateral attachment system;

withdrawing the ipsilateral capsule means from the ipsilateral inferior end of the bifurcated graft to expose the ipsilateral attachment system; and

removing the delivery catheter from the corporeal lumen, wherein the bifurcated graft remains secured within the corporeal lumen.

2. The method of claim 1, wherein the positioning step includes placing the bifurcated graft proximate an aneurism proximate an aortic bifurcation.

3. A method for engrafting a bifurcated prosthesis into a corporeal lumen, the bifurcated prosthesis having a superior end, an ipsilateral end and a contralateral end, the bifurcated prosthesis further having a superior attachment system at the superior end, an ipsilateral attachment system at the ipsilateral end and a contralateral attachment system at the contralateral end, said method comprising the steps of:

(a) providing delivery means for positioning a bifurcated prosthesis in a corporeal lumen, wherein the delivery means comprises distal capsule means for removably retaining a superior attachment system, ipsilateral capsule means for removably retaining an ipsilateral attachment system and contralateral capsule means for removably retaining a contralateral attachment system;

(b) providing capsule jacket means for removably retaining the bifurcated prosthesis, distal capsule means, ipsilateral capsule means and contralateral capsule means;

(c) placing the superior attachment system of the bifurcated prosthesis into the distal capsule means;

(d) placing the ipsilateral attachment system of the bifurcated prosthesis into the ipsilateral capsule means;

(e) placing the contralateral attachment system of the bifurcated prosthesis into the contralateral capsule means;

(f) placing the bifurcated prosthesis and the delivery means into the capsule jacket means;

(g) creating an opening in the corporeal lumen for traversing the capsule jacket means, the delivery means and the bifurcated prosthesis therethrough;

(h) inserting the capsule jacket means, the delivery means and the bifurcated prosthesis into the opening in the corporeal lumen;

(i) urging the bifurcated prosthesis to a desired location within the corporeal lumen;

(j) withdrawing the capsule jacket means proximally to expose the distal capsule means;

(k) positioning the distal capsule means at a desired location within the corporeal lumen;

(l) activating the superior attachment system to secure the superior end of the bifurcated prosthesis within the corporeal lumen;

(m) positioning the contralateral capsule means at a desired location within the corporeal lumen;

(n) activating the contralateral attachment system to secure the contralateral end of the bifurcated prosthesis within the corporeal lumen;

(o) positioning the ipsilateral capsule means at a desired location within the corporeal lumen;

(p) activating the ipsilateral attachment system to secure the ipsilateral end of the bifurcated prosthesis within the corporeal lumen;

(q) removing the delivery means from the corporeal lumen; and

(r) closing the opening in the corporeal lumen.

4. The method of claim 3, said method further comprising the steps of:

(s) withdrawing the capsule jacket means proximally to expose the bifurcated prosthesis, contralateral capsule means and at least a portion of the ipsilateral capsule means after performing step (i) and prior to performing step (k);

(t) removing the superior attachment system from the distal capsule means after performing step (k) and prior to performing step (l);

(u) removing the contralateral attachment system from the contralateral capsule means after performing step (m) and prior to performing step (n); and

(v) removing the ipsilateral attachment system from the ipsilateral capsule means after performing step (o) and prior to performing step (p).

8. The method of claim 3, said method further comprising the steps of:

(s) withdrawing the capsule jacket proximally to expose the bifurcated prosthesis, contralateral capsule and at least a portion of the ipsilateral capsule after performing step (i) and prior to performing step (k);

(t) removing the superior attachment system from the distal capsule after performing step (k) and prior to performing step (l);

(u) removing the contralateral attachment system from the contralateral capsule after performing step (m) and prior to performing step (n); and

(v) removing the ipsilateral attachment system from the ipsilateral capsule after performing step (o) and prior to performing step (p).

5. A method for securing a bifurcated graft in a corporeal lumen, the bifurcated graft having a superior end, an ipsilateral inferior end and a contralateral inferior end, the bifurcated graft further having a superior attachment system disposed proximate the superior end, an ipsilateral attachment system disposed proximate the ipsilateral inferior end and a contralateral attachment system disposed proximate the contralateral inferior end, said method comprising the steps of:

providing a delivery catheter assembly having three distinct capsules including a distal capsule that contains the superior attachment system of the bifurcated graft, an ipsilateral capsule that contains the ipsilateral attachment system and a contralateral capsule that contains the ipsilateral attachment system;

positioning the delivery catheter assembly and the bifurcated graft at a desired location within a corporeal lumen;

moving the distal capsule distally with respect to the superior end of the bifurcated graft to expose the superior attachment system;

withdrawing the contralateral capsule from the contralateral inferior end of the bifurcated graft to expose the contralateral attachment system;

withdrawing the ipsilateral capsule from the ipsilateral inferior end of the bifurcated graft to expose the ipsilateral attachment system; and

removing the delivery catheter from the corporeal lumen, wherein the bifurcated graft remains secured within the corporeal lumen.

6. The method of claim 5, wherein the positioning step includes placing the bifurcated graft proximate an aneurism proximate an aortic bifurcation.

7. A method for engrafting a bifurcated prosthesis into a corporeal lumen, the bifurcated prosthesis having a superior end, an ipsilateral end and a contralateral end, the bifurcated prosthesis further having a superior attachment system at the superior end, an ipsilateral attachment system at the ipsilateral end and a contralateral attachment system at the contralateral end, said method comprising the steps of:

(a) providing a delivery system which positions a bifurcated prosthesis in a corporeal lumen, wherein the delivery system comprises a distal capsule that removably retains a superior attachment system, an ipsilateral capsule that removably retains an ipsilateral attachment system and a contralateral capsule that removably retains a contralateral attachment system;

(b) providing a capsule jacket that removably retains the bifurcated prosthesis, distal capsule, ipsilateral capsule and contralateral capsule;

(c) placing the superior attachment system of the bifurcated prosthesis into the distal capsule;

(d) placing the ipsilateral attachment system of the bifurcated prosthesis into the ipsilateral capsule;

(e) placing the contralateral attachment system of the bifurcated prosthesis into the contralateral capsule;

(f) placing the bifurcated prosthesis and the delivery means into the capsule jacket;

(g) creating an opening in the corporeal lumen for traversing the capsule jacket, the delivery system and the bifurcated prosthesis therethrough;

(h) inserting the capsule jacket, the delivery system and the bifurcated prosthesis into the opening in the corporeal lumen;

(i) urging the bifurcated prosthesis to a desired location within the corporeal lumen;

(j) withdrawing the capsule jacket proximally to expose the distal capsule;

(k) positioning the distal capsule at a desired location within the corporeal lumen;

(l) activating the superior attachment system to secure the superior end of the bifurcated prosthesis within the corporeal lumen;

(m) positioning the contralateral capsule at a desired location within the corporeal lumen;

(n) activating the contralateral attachment system to secure the contralateral end of the bifurcated prosthesis within the corporeal lumen;

(o) positioning the ipsilateral capsule at a desired location within the corporeal lumen;

(p) activating the ipsilateral attachment system to secure the ipsilateral end of the bifurcated prosthesis within the corporeal lumen;

(q) removing the delivery system from the corporeal lumen; and

(r) closing the opening in the corporeal lumen.