Single puncture bifurcation graft deployment system

• US 6,261,316 B1
• Filed: 03/11/1999
• Issued: 07/17/2001
• Est. Priority Date: 03/11/1999
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Shaolian, Samuel M., Madrid, Gilbert, Nguyen, Thanh Van, Pham, To Van, Pham, Trinh Van
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): King, Anthony S.
• Application Number:
  US09/266,661
• Time in Patent Office: 859 Days
• Field of Search: 623/1.11, 623/1.23, 623/1, 606/194, 606/195, 606/198, 604/284, 604/280, 604/281, 604/283
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An endoluminal repair of abdominal aortic aneurysms at the aortic and iliac bifurcation. In particular, a deployment system and graft are disclosed for deploying the bifurcated graft within both iliac branches, as well as the aortic trunk, from a single vascular access. The disclosed deployment system includes a delivery catheter having a releasable restraint for the main body section of the graft and separate releasable restraints for each of the first and second branch sections of the graft.

Claims

1. A single puncture bifurcation graft deployment system, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end, said catheter body having a user manipulating portion at said proximal end;

a main vessel graft restraint, for restraining a main vessel portion of a bifurcated graft;

a first branch vessel graft restraint, for restraining a first branch vessel portion of the graft, wherein the first branch vessel graft restraint is separate from and oriented proximal to the main vessel graft restraint with respect to the catheter; and

a second branch vessel graft actuator, separate from the main vessel graft restraint and the first branch vessel graft restraint, for actuating a second branch vessel portion of the graft;

wherein each of the main vessel graft restraint, first branch vessel graft restraint, and the second branch vessel graft actuator are operable such that the bifurcated graft is implantable by way of a single vascular access site.

2. A deployment system as in claim 1, wherein the second branch vessel actuator comprises an elongate, flexible, axially moveable release element extending along a length of the catheter body.

3. A deployment system as in claim 2, further comprising a removable second branch vessel graft restraint attached to the release element.

4. A deployment system as in claim 3, wherein the second branch vessel graft restraint comprises a peelable cover.

5. A deployment system as in claim 1, wherein the main vessel graft restraint comprises a tubular sleeve.

6. A deployment system as in claim 1, wherein the first branch vessel graft restraint comprises a tubular sleeve.

7. A deployment system as in claim 1, wherein the second branch vessel actuator comprises an elongate, flexible, axially moveable release element extending along a length of the catheter body.

8. A deployment system for deploying a bifurcated prosthesis at the junction of a main vessel and first and second branch vessels, comprising:

a delivery catheter having proximal and distal ends and an inner core connected to a tubular housing, the inner core being slidably engaged within a middle core with proximal and distal ends, wherein at least the distal end of the middle core comprises a tubular sheath, the middle core being slidably engaged within an outer sheath;

a bifurcated prosthesis having a main body section with proximal and distal ends, and first and second branch sections at the proximal end of the main body section, relative to the delivery catheter, wherein the main body section is held in a radially compressed state within the tubular housing of the inner core, the first branch section is held in a radially compressed state within the tubular sheath of the middle core, and the second branch section is disposed within the outer sheath in a radially compressed state; and

a second branch section actuator for expanding the second branch section of the prosthesis.

9. The deployment system of claim 8, wherein the second branch section actuator comprises a restraining wire.

10. The deployment system of claim 8, wherein the second branch section actuator comprises a slideable sheath and a release wire attached to the slideable sheath.

11. The deployment system of claim 8, wherein the second branch section actuator comprises a water-soluble adhesive.

12. The deployment system of claim 8, wherein the second branch section comprises a memory metal and the second branch section actuator comprises an electrical conductor in contact with the memory metal and coupled to a power supply or generator.

13. A deployment system for deploying a bifurcated prosthesis at the junction of a main vessel and first and second branch vessels, comprising:

a delivery catheter having an inner core connected to a tubular housing, the inner core being slidably engaged within a middle core with proximal and distal ends, wherein at least the distal end of the middle core comprises a tubular sheath, the middle core being slidably engaged within an outer sheath; and

a bifurcated prosthesis having a main body section with proximal and distal ends, and first and second branch sections at the proximal end of the main body section, wherein the main body section is held in a radially compressed state within the tubular housing of the inner core, the first branch section is held in a radially compressed state within the tubular sheath of the middle core, and the second branch section is disposed within the outer sheath in a radially compressed state,

wherein the bifurcated prosthesis further comprises an expansion spring having an apex and first and second leg portions, wherein the leg portions are connected to respective first and second branch sections.

14. A single puncture bifurcation graft deployment system, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end, said catheter body having a user manipulating portion at said proximal end;

a main graft restraint for restraining a main portion of a bifurcated graft;

a first branch graft restraint separate from the main graft restraint, for restraining an ipsilateral branch portion of the graft;

a peelable sleeve separate from the main graft restraint and the first branch graft restraint, for restraining a second branch portion of the graft; and

an axially moveable release wire attached to the peelable sleeve;

wherein each of the main graft restraint, first branch graft restraint, and the peelable sleeve are operable through the catheter body so that the catheter can be used to implant a bifurcation graft by way of a single vascular access site.