Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
2001-12-20
2003-11-04
Truong, Kevin T. (Department: 3731)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
Reexamination Certificate
active
06641606
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a delivery system and method for deploying an endovascular prosthesis.
BACKGROUND OF THE INVENTION
Vascular aneurysms, which result from abnormal dilation of a blood vessel, can occur in any blood vessel. For instance, vascular aneurysms can occur in the aorta and peripheral arteries of the aorta. The majority of aortic aneurysms occur in the abdominal aorta below the renal arteries. Often the abdominal aortic aneurysm extends into areas of bifurcation (e.g., the inferior end of the aorta where it bifurcates into the iliac arteries) or segments of the aorta from which small branch arteries extend.
Techniques have been developed for repairing abdominal aortic aneurysms by intraluminally delivering an endovascular graft to the aneurysm site through the use of a catheter-based delivery system. The endovascular grafts typically comprise a tube of pliable material (e.g., expanded polytetrafluoroethylene (ePTFE) or woven polyester) in combination with a graft anchoring component, which operates to hold the tubular graft in its intended position within the aorta. Most commonly, the graft anchoring component is formed of a stent or frame that is radially expandable to exert outwardly directing radial pressure against the surrounding blood vessel wall. The stent or frame can be either attached to or incorporated into the body of the tubular graft or provided separate from the graft and deployed within the graft.
Unfortunately, not all patients diagnosed with abdominal aortic aneurysms are considered to be candidates for endovascular grafting. Most endovascular grafts, which have been designed for treating abdominal aortic aneurysms, require the patient being treated have a proximal aortic neck inferior the renal arteries of at least 1 cm in length and a distal iliac neck less than 2.0 cm in diameter.
Additionally, the deployment of endovascular grafts within regions of the aorta from which the renal, superior mesenteric, celiac, intercostal, and/or subclavian arteries extend present additional technical challenges because, in those cases, it is advantageous to design, implant, and maintain, the endovascular graft in a manner which does not impair the flow of blood into these arteries.
SUMMARY OF THE INVENTION
The present invention relates to an apparatus for delivering an endovascular prosthesis within a blood vessel. The apparatus includes a sheath with a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen for receiving a guide wire. The inner lumen extends along a central axis between the first end and the second end. The outer lumen is radially spaced from the inner lumen and extends along an outer axis between the ends.
Another aspect of the present invention relates to a delivery system for placing an endovascular prosthesis within a blood vessel. The delivery system comprises a sheath and a nosecone. The sheath has a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen for receiving a guide wire. The inner lumen extends along a central axis between a first opening in the first end and a second opening in the second end. The outer lumen extends along an outer axis between the first end and the second end. The outer lumen is radially spaced from the inner lumen and extends parallel to the inner lumen. The nosecone has a proximal end, a distal end, and a guide wire lumen extending between the proximal end and the distal end. The proximal end of the nosecone is connectable to the first end of the sheath allowing the guide wire lumen of the nosecone to communicate with the outer lumen of the sheath.
The present invention also provides a method of deploying an endovascular prosthesis, which is expandable from a collapsed condition to an expanded condition, within a vasculature. In the method, a guide wire having a distal end and proximal end is provided. The distal end of the guide wire extends within the vasculature. A delivery system is also provided. The delivery system includes a sheath. The sheath has a first end, a second end, an inner lumen for receiving the endovascular prosthesis in a collapsed condition, and an outer lumen for receiving the guide wire. The inner lumen extends along a central axis between a first opening in the first end and a second opening in the second end. The outer lumen extends along an outer axis between the first end and the second end of the sheath. The outer lumen is radially spaced from the inner lumen and extends parallel to the inner lumen.
The endovascular prosthesis is loaded in collapsed condition into the inner lumen of the sheath. The proximal end of the guide wire is inserted through the outer lumen of the sheath. The sheath, with the loaded endovascular prosthesis, is advanced over the guide wire within the vasculature. The endovascular prosthesis is maneuvered from the inner lumen of the sheath.
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Clair Daniel G.
Ouriel Kenneth
Bui Vy Q.
Cleveland Clinic Foundation
Tarolli, Sundheim Covell & Tummino L.L.P.
Truong Kevin T.
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