Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Patent
1995-06-02
1996-10-08
Shay, Randy C.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
623 12, 606195, 606198, A61F 206
Patent
active
055627242
DESCRIPTION:
BRIEF SUMMARY
The invention relates to 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 extending 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.
In particular, the invention is concerned with the repair of an aneurysm in the vicinity of the aortic bifurcation, but it may also be applied to other parts of the arterial system where a principal upstream arteria bifurcates into two branch arteries.
In order to prevent an aortic aneurysm, in particular in the lower part of the aorta close to the aortic bifurcation from causing a dangerous rupture of the aortic wall it is known to deploy a graft prosthesis in the region of the vessel affected by such an aneurysm.
An aortic aneurysm may develop as a result of a reduction of the strength of the aortic wall whereby the diameter of the affected part of the aorta may increase to more than 5 cm. Such expansions may result in flow irregularities and promotion of deposits of coagulated blood in the affected region. At increased expansion the remaining strength of the aortic wall will naturally decrease and may ultimately result in rupture of the vessel with an inherent danger of acute bleeding.
With conventional prior art endovascular prosthesis for aortic implantation surgical opening of the actual vascular section will be necessary for deployment of the prosthesis. For this purpose a partial cut is made in the wall of the aneurysm to introduce the prosthesis formed as an integral unit of a plastic material and secure it by sewing.
From EP-A-0508473 and EP-A-0539237 bifurcated graft prosthesis are known which may be transluminarly implanted for the repair of an aneurysm at or in the vicinity of the aortic bifurcation. In both cases the bifurcated prosthesis is made as an integral unit with a main body and two tubular legs joining the main body in a bifurcation. Due to this design the implantation operation becomes relatively complicated since the integral unit must be introduced through one of the iliac arteries with one of the legs in a fold-over condition until the graft is disposed proximal of the aortic bifurcation following which the proximal extremity of the prosthesis must be secured upstream of the actual vascular section and the folded overleg must be pulled down into the other iliac arteria.
It is the object of the invention to provide an endovascular graft prosthesis of the kind set forth for transluminal implantation at the aortic bifurcation by a considerably simpler implantation operation than the above-mentioned prior art solutions.
In order to achieve this an endovascular graft prosthesis according to the invention is characterized in that the main body is substantially bag-shaped with an open proximal upstream end and a distal downstream bottom region in which two outlet openings are provided, said main body being radially expandable and attachable in a radially expanded condition to the inner side of said upstream arteria upstream of the bifurcation by fixation means, said legs being made as separate resilient and radially expandable leg stent devices adapted for introduction in a collapsed condition through said branch arteries and into said outlet openings, each of said stent devices being engageable in its radially expanded condition against the rim of the corresponding outlet opening to provide a leakage-free bifurcated graft prosthesis.
By making up the prosthesis from a number of separate components which may be sequentially introduced in the arterial system by percutaneous operations through small openings with a punctual diameter up to 5 mm the components may be endovascularly assembled to a complete prosthesis after deployment in the actual vascular section. Thereby, the prosthesis acco
Gunther Rolf W.
Schmitz-Rode Thomas
Vorwerk Dierk
Godlewski Richard J.
Shay Randy C.
William Cook Europe A/S
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