Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis
Reexamination Certificate
2000-11-20
2003-11-25
Prebilic, Paul B. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
C623S001390, C623S001110, C623S001230
Reexamination Certificate
active
06652567
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to vascular grafts and prostheses for repair of damaged or aneurismal blood vessels. More particularly, it relates to a fenestrated endovascular graft for repair of blood vessels with tributary vessels or sidebranches and methods for placing the endovascular graft in the vessel and for making a fluid connection or anastomosis with one or more of the sidebranches.
BACKGROUND OF THE INVENTION
Vascular grafts or vascular prostheses are commonly used for repair of damaged or aneurismal blood vessels. Standard technique involves implanting a vascular graft into a patient to repair or replace a damaged or diseased section of the blood vessel using open surgical methods. The ends of the vascular graft are typically anastomosed to the blood vessel using sutures, surgical staples or clips. The native vessel may be removed or left in situ, depending on the surgical technique used and the nature of the damage or disease to the vessel. In recent years, techniques have been developed for implanting a vascular graft using minimally-invasive techniques in order to reduce the trauma of surgery. Typically, such vascular grafts are delivered transluminally and implanted within the lumen of the native blood vessel, hence they are often referred to as endovascular grafts, endoluminal grafts or endovascular prostheses. The ends of the endovascular graft are typically held in place by hooks, surgical staples or clips. Sometimes the ends of the endovascular graft and/or the body of the graft are supported by a stent or other reinforcement. A stent is a metallic and/or polymeric scaffold that holds the ends and/or the body of the graft in an open position. These grafts are typically referred to as stent-grafts or reinforced grafts. The stent or reinforcement may be self-expanding or an inflatable balloon or other expandable dilator may be used to expand the stent and/or the graft. The stent may also include anchoring hooks or clips to hold the stent-graft in place within the vessel. A common application for endovascular grafts of this sort is for repair of abdominal aortic aneurysms or AAA's. Depending on the location and extent of the disease, endovascular grafts for repair of abdominal aortic aneurysms may be straight for use in the abdominal descending aorta or they may be bifurcated for connecting from the descending aorta to the iliac or femoral arteries.
The following U.S. patents disclose bifurcated and nonbifurcated endovascular grafts for repair of abdominal aortic aneurysms and the like. These patents and all of the patents referred to therein are hereby incorporated by reference: U.S. Pat. No. 5,957,973 Multicapsule intraluminal grafting system and method; U.S. Pat. No. 5,935,122 Dual valve, flexible expandable sheath and method; U.S. Pat. No. 5,910,144 Prosthesis gripping system and method; U.S. Pat. No. 5,824,044 Bifurcated multicapsule intraluminal grafting system; U.S. Pat. No. 5,824,039 Endovascular graft having bifurcation and apparatus and method for deploying the same; U.S. Pat. No. 5,800,518 Method for deploying an endovascular graft having a bifurcation; U.S. Pat. No. 5,782,909 Multicapsule intraluminal grafting system and method; U.S. Pat. No. 5,769,885 Bifurcated multicapsule intraluminal grafting system and method; U.S. Pat. No. 5,749,920 Multicapsule intraluminal grafting system and method; U.S. Pat. No. 5,693,083 Thoracic graft and delivery catheter; U.S. Pat. No. 5,669,936 Endovascular grafting system and method for use therewith; U.S. Pat. No. 5,662,700 Artificial graft and implantation method; U.S. Pat. No. 5,653,697 Dual valve reinforced sheath and method; U.S. Pat. No. 5,628,783 Bifurcated multicapsule intraluminal grafting system and method; U.S. Pat. No. 5,609,625 Endovascular graft having bifurcation and apparatus and method for deploying the same; U.S. Pat. No. 5,489,295 Endovascular graft having bifurcation and apparatus and method for deploying the same; U.S. Pat. No. 5,484,418 Dual valve reinforced sheath and method; U.S. Pat. No. 5,419,324 Radiological marker board with movable indicators; U.S. Pat. No. 5,397,345 Artificial graft and implantation method; U.S. Pat. No. 5,395,349 Dual valve reinforced sheath and method; U.S. Pat. No. 5,256,150 Large-diameter expandable sheath and method; U.S. Pat. No. 5,209,731 Hand-held gun for inflating and aspirating large volume balloons; and U.S. Pat. No. 5,104,399 Artificial graft and implantation method.
While such endovascular grafts represent a significant step forward in the treatment of vascular disease, there remain technical and clinical challenges that the current graft technology does not address. In specific, known vascular grafts and endovascular grafts are not well adapted for implantation into vessels, such as the aorta, having tributary vessels or sidebranches along the section of the blood vessel to be repaired without occluding or obscuring the sidebranches. The present invention provides a technical solution for this previously unsolved clinical challenge.
SUMMARY OF THE INVENTION
In keeping with the foregoing discussion, the present invention takes the form of a vascular graft for repair of diseased, damaged or aneurismal blood vessels. In a particularly preferred embodiment, the vascular graft is in the form of an endovascular graft configured to be delivered transluminally and implanted within the lumen of a native blood vessel using catheter-based minimally-invasive surgical techniques. Preferably, the vascular graft is fenestrated or perforated to facilitate making a fluid connection or anastomosis with one or more of the sidebranches of the vessel into which it is implanted. Thus, the vascular graft of the present invention is adapted for implantation into blood vessels, such as the aorta, having tributary vessels or sidebranches along the section of the blood vessel to be repaired without occluding or obscuring the sidebranches.
Methods are described for implanting the vascular graft into a patient's aorta for repairing thoracic or abdominal aortic aneurysms and for making a fluid connection or anastomosis with the tributary vessels or sidebranches of the aorta, such as the renal, hepatic and mesenteric arteries.
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Leary James J.
Prebilic Paul B.
Titus Carol D.
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