Expandable transluminal graft prosthesis for repair of aneurysm and method for implanting

• US 5,562,726 A
• Filed: 12/22/1993
• Issued: 10/08/1996
• Est. Priority Date: 10/25/1991
• Status: Expired due to Term

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Chuter, Timothy A.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/173,148
• Time in Patent Office: 1,021 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 604/7, 604/8, 604/96
• US Class Current: 623/1.35
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A transluminal grafting system for grafting a prosthesis to the wall of a lumen includes a tubular graft provided with spring assemblies and anchoring barbs. The prosthesis is mounted on an apertured tubular carrier and a central control means is inserted into the bore of the apertured carrier. Mooring loops are attached to the prosthesis, pass through the apertures of the tubular carrier, and engage the central control means. An introducer sheath covers the system for smooth insertion into a lumen. When the graft has been positioned, the central control means maintains the axial position of the prosthesis. When the introducer sheath is pulled, the prosthesis is exposed and the spring assemblies return to an expanded state and anchor the graft against the internal wall of the lumen.

Claims

1. A self-expanding prosthesis for repairing an aneurysm, comprising:

a bifurcated endovascular graft having a main body and first and second limbs extending therefrom, said main body including a main bore extending longitudinally therein and having a cranial orifice, said first limb including a first bore extending longitudinally therein, communicating with said main bore, and having a first caudal orifice, said second limb including a second bore extending longitudinally therein, communicating with said main bore, and having a second caudal orifice;

a first radio-opaque, imageable marker extending longitudinally along said first limb;

a second radio-opaque, imageable marker extending longitudinally along said first limb and spaced at least a predetermined distance away from said first marker;

a self-expanding stent positioned in said main bore about said cranial orifice;

a tubular introducer sheath having a single wall and a sheath bore of a constant diameter extending longitudinally therethrough; and

a central carrier coaxially positionable within said sheath bore of said sheath, said central carrier including a vascular dilator head region having a fixed shape, a portion mating with and approximating said constant diameter of said sheath bore, a shaft region approximating said constant diameter of said sheath bore, and a stem region positioned between said head and shaft regions and being smaller than said constant diameter of said sheath bore for positioning coaxially said self-expanding cranial stent, said main body and at least one of said first and said second limbs of said graft therearound and in said sheath bore.

2. The prosthesis of claim 1 wherein said self-expanding cranial stent includes at least one barb.

3. The prosthesis of claim 1 further comprising a first caudal stent positionable in said first bore.

4. The prosthesis of claim 3 wherein said first caudal stent includes at least one barb.

5. The prosthesis of claim 3 further comprising a second caudal stent positionable in said second bore.

6. The prosthesis of claim 5 wherein said second caudal stent includes at least one barb.

7. The prosthesis of claim 1 further comprising a third radio-opaque, imageable marker positioned about said second caudal orifice of said second limb.

8. The prosthesis of claim 7 further comprising a fourth radio-opaque, imageable marker positioned about said second caudal orifice of said second limb and positioned a predetermined distance away from said third imageable marker.

9. Method of inserting a self-expanding, bifurcated prosthesis in an aneurysm utilizing a prosthesis delivery system, comprising the steps of:

providing a bifurcated endovascular prosthesis having a main body and first and second limbs extending therefrom, said main body including a main bore extending longitudinally therein and having a cranial orifice, said first limb including a first bore extending longitudinally therein, communicating with said main bore, and having a first caudal orifice, said second limb including a second bore extending longitudinally therein, communicating with said main bore, and having a second caudal orifice;

providing a self-expanding stent positioned in said main bore about said cranial orifice;

providing a first radio-opaque, imageable marker extending longitudinally along said first limb;

providing a second radio-opaque, imageable marker extending longitudinally along said first limb and spaced at least a predetermined distance away from said first marker;

providing a prosthesis delivery system including a tubular introducer sheath having a single wall, a sheath bore of a constant diameter extending longitudinally therethrough and a central carrier coaxially positionable within said sheath bore of said sheath, said central carrier including a vascular dilator head region having a fixed shape, a portion mating with and approximating said constant diameter of said sheath bore, a shaft region having a dimension approximating said constant diameter of said sheath bore, and a stem region positioned between said head and shaft regions and being smaller than said constant diameter of said sheath bore for positioning coaxially said self-expanding cranial stent said main body and at least one of said first and said second limbs of said prosthesis therearound and in said sheath bore;

percutaneously obtaining cross access with a first guide between femoral arteries positioned caudal to said aneurysm;

percutaneously obtaining access to a lumen of said aneurysm with a second guide;

positioning said prosthesis in said aneurysm and one limb thereof in one of said femoral arteries with said prosthesis delivery system and said second guide;

positioning an other limb of said prosthesis in the other of said femoral arteries with said first guide; and

releasing said prosthesis from said delivery system when said prosthesis is positioned in said aneurysm.