Endovascular graft prosthesis and an implantation method for such a prosthesis

• US 5,562,724 A
• Filed: 06/02/1995
• Issued: 10/08/1996
• Est. Priority Date: 12/15/1993
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: William Cook Europe ApS (Cook Group Incorporated)
• Inventors: Vorwerk, Dierk, Schmitz-Rode, Thomas, Gunther, Rolf W.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/446,761
• Time in Patent Office: 494 Days
• Field of Search: 623/1, 623/11, 623/12, 606/108, 606/191, 606/194, 606/195, 606/198, 604/96, 604/104, 604/281
• US Class Current: 623/1.13
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An endovascular graft prosthesis for arrangement at or in the vicinity of a bifurcation in the arterial system of a patient, e.g. for the purpose of repairing an aneurysm or the aortic bifurcation comprises a substantially tubular main body for location in the principal upstream arteria above the bifurcation such as th aorta and substantially tubular legs joining said main body in a bifurcation and extending into each of two branch arteries such as the iliac arteries. The main body (8) is substantially bag-shaped with an open proximal upstream end and a distal downstream bottom region in which two outlet openings (9, 10) are provided and is attachable to the inner side of the principal arteria (2) by means of an expandable stent device (11). The legs are made as separate expandable leg stent devices (15, 16) which may be introduced in a collapsed condition through the branch arteries and into the outlet openings (9,10) of the main body by means of guide wires (13,14) to engage against the rim of the corresponding outlet opening to provide a leakage-free bifurcated graft prosthesis.

Claims

1. An endovascular graft prosthesis for arrangement at or in the vicinity of a bifurcation in the arterial system of a patient and comprising a substantially tubular main body for location in an upstream arteria above the bifurcation and substantially tubular legs joining said main body and adapted to extend via the bifurcation into each of two downstream branch arteries, said main body being made of a flexible microporous and surgically implantable woven material unpenetratable to blood, wherein the main body (8) is substantially bag-shaped with an open proximal upstream end having fixation means attached thereto and a distal downstream bottom region in which two outlet openings (9, 10) are provided, said main body being radially expandable and attachable in a radially expanded condition to the inner side of said upstream arteria (2) upstream of the bifurcation by said fixation means (11), said legs being separate resilient and radially expandable leg stent devices (15, 16) adapted for introduction in a collapsed condition through said branch arteries and into said outlet openings (9, 10) of said main body, each of said stent devices (15, 16) being engageable in its radially expanded condition against a rim of the corresponding outlet opening to provide a leakage-free bifurcated graft prosthesis.

2. An endovascular graft prosthesis as claimed in claim 1, wherein said fixation means comprises a main stent device (11) and is attached to the bag-shaped main body (8) with a downstream distal end of the main stent device (11) overlapped by the upstream proximal end of the main body (8).

3. An endovascular graft prosthesis as claimed in claim 2, wherein said main stent device (11) and leg stent devices (15, 16) include expandable metal stents.

4. An endovascular graft prosthesis as claimed in claim 3, wherein each outlet opening (9, 10) is positioned in the downstream direction.

5. An endovascular graft prosthesis as claimed in claim 4, wherein the maximum external diameter of each of the leg stent devices (15, 16) is 2-4 mm greater than the minimum rim diameter of each outlet opening (9, 10).

6. An endovascular graft prosthesis as claimed in claim 2, wherein each outlet opening (9, 10) is positioned in the downstream direction.

7. An endovascular graft prosthesis as claimed in claim 6, wherein the maximum external diameter of each of the leg stent devices (15, 16) is 2-4 mm greater than the minimum rim diameter of each outlet opening (9, 10).

8. An endovascular graft prosthesis as claimed in claim 1, wherein each outlet opening (9, 10) is positioned in the downstream direction.

9. An endovascular graft prosthesis as claimed in claim 8, wherein the maximum external diameter of each of the leg stent devices (15, 16) is 2-4 mm greater than the minimum rim diameter of each outlet opening (9, 10).

10. A method for implanting an endovascular graft prosthesis at or in the vicinity of a bifurcation in the arterial system of a patient and associated branch arteries, comprising the steps of:

introducing through a first branch arteria (5) in an upstream direction via a first guide wire (12) a separate, radially expandable and substantially bag shaped main body (8) into an upstream arteria to extend into a region thereof above the bifurcation, said main body having an open proximal upstream end with associated fixation means and a distal downstream bottom region in which two outlet openings (9,

     10) are provided;

expanding said main body radially in said upstream arteria such that said proximal end becomes attached to the wall thereof; and

introducing via other wires (12, 13, or

     14) a radially expandable leg stent device (15,

     16) through each of the branch arteries (5,

     6) into each of said outlet openings.

11. An implantation method as claimed in claim 10, further comprising introducing a catheter through each of the branch arteries over each end of said first guide wire prior to the removal thereof, said catheters being subsequently used for introduction of said other guide wires.