Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Patent
1993-02-24
1995-04-11
Green, Randall L.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
623 12, A61F 206, A61F 204
Patent
active
054053790
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a self expanding vascular endoprosthesis for aneurysms and to apparatus and a method for introducing such an endoprosthesis into an artery.
BACKGROUND ART
An Aneurysm is the focal abnormal dilation of an artery. The complications which arise from aneurysms are specifically rupture, embolisation, fistularisation and symptoms related to pressure on surrounding structures. Aneurysms are commonly found in the abdominal aorta, being that part of the aorta which extends from the diaphragm to the point at which the aorta bifurcates into the common iliac arteries. These abdominal aortic aneurysms typically occur between the point at which the renal arteries branch from the aorta and the bifurcation of the aorta.
The standard treatment for aneurysms is to resect them by opening the aneurysm directly and inserting an inlaid graft made of a biocompatible material such as Dacron. The operation in most cases is large entailing considerable blood loss, at least 10 days in hospital and a mortality rate of about 5% in elective cases. This mortality rate is normally related to associated vascular problems such as myocardial infarction. Many patients cannot be subjected to such a large procedure because of intercurrent disease and therefore die of the aneurysm or the complications thereof.
It has been proposed by Balka etal. (Journal of Surgical Research 40 305-309 (1986)) to treat abdominal aortic aneurysms by the insertion of an intraluminal prosthesis, which approximates the diameter of the aorta above and below the aneurysm, into the aorta through the common femoral artery. In this case the prosthesis comprised a polyurethane tube with a nitinol and/or stainless steel frame which was designed in such a configuration that it can be compressed inside a catheter and then regain its original shape after being discharged into the aorta. This proposal does not appear to have been adopted for the treatment of humans due to difficulty in ensuring that the prosthesis will expand sufficiently to form a seal with the aorta above and below the aneurysm. The present inventor has developed a prosthesis which provides an alternative to that proposed by Balka et al.
In a first aspect the present invention consists in a self expanding vascular endoprosthesis adapted to bridge across an aneurysm in an artery, the endoprosthesis comprising a substantially imperforate sheet of a resiliently flexible biocompatible material, the sheet being rolled upon itself about one of its longitudinal edges, the material from which the sheet is formed being such that resiliently expand of its own volition to press firmly against the internal wall of the artery to bridge across the aneurysm and to fluid isolate it from blood flowing in the artery, and will be a compliance mismatch between the endoprosthesis and the wall of the artery to induce sufficient cellular proliferation in that wall adjacent the ends of an implanted endoprosthesis to cause the endoprosthesis to be adhered to the arterial wall.
In a second aspect the present invention consists in apparatus for introducing a self expanding vascular endoprosthesis for aneurysms into an artery, comprising an elongate tubular catheter, a self expanding vascular prosthesis for aneurysms according to the present invention disposed within the catheter and means for ejecting the endoprosthesis from the catheter.
In a third aspect the present invention consists in a method for treating an aneurysm in an artery by introducing a self expanding endoprosthesis into the artery, the method comprising the steps of:
inserting one end of a catheter containing a self expanding vascular endoprosthesis according to any one of claims 1 to 5 into an artery communicating with the artery having the aneurysm,
moving the catheter along the patient's vascular system until the end of the catheter is adjacent the aneurysm,
ejecting the endoprosthesis from one end of the catheter such that it bridges across the aneurysm and expands firmly into contact with the wall of th
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R. J. Lane. "The treatment of abdominal aortic . . . " Project report submitted as part of requirement for degree in Master of Biomedical Engineering, University of South Wales, 1993. Whole thesis.
Brittingham Debra S.
Green Randall L.
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