Endovascular prosthetic heart valve replacement
First Claim
1. A method for implanting a prosthetic aortic valve in a native aortic valve annulus location, said method comprising:
- providing a replacement aortic prosthetic valve having;
a lower base portion comprising an inner tubular wall having a first height and comprising a balloon-expandable metal support scaffold covered with a material that inhibits paravalvular leakage and an outer tubular wall having a second height and comprising a self-expandable metal support scaffold covered with a material that inhibits paravalvular leakage, wherein the first height is greater than the second height and at least a portion of the inner tubular wall is disposed within the outer tubular wall and a separate upper valve portion comprising a lower engagement region and a balloon-expandable upper leaflet structure and wherein the outer tubular wall of the lower base portion is adapted to be expanded within a heart valve annulus and conform to the irregularities of shape of the heart valve annulus and the inner tubular wall is adapted to maintain a circular orientation after expansion;
positioning the replacement aortic prosthetic valve in the native aortic valve location so that the lower base portion is located within the native aortic valve annulus and the lower engagement region of the upper valve portion is located within the inner tubular wall of the lower base portion such that the upper valve portion is located within or above the native aortic valve annulus; and
simultaneously expanding the lower engagement region of the upper valve portion and the inner tubular wall such that the lower engagement region securely engages the inner tubular wall and expanding the upper leaflet structure such that the expanded upper leaflet structure assumes an increased cross-sectional area relative to the lower base portion.
3 Assignments
0 Petitions
Accused Products
Abstract
A prosthetic aortic valve intended for native or valve-in-valve within bioprostheses includes an expandable support scaffold and valve leaflets disposed within an upper leaflet portion of the support scaffold. The valve leaflets within the upper portion may be located within the annulus (intravalvular), above the annulus, or above the native or prosthetic leaflets (supravalvular). The valve within a previously implanted degenerated heart valve such that a base or lower portion of the replacement valve is within the previously implanted valve and the upper portion is expanded within the aorta, the internal area of the valve can be increased and the hemodynamics of the valve improved. Alternatively, the valve may include separate upper and lower portions allowing the portions to be implanted sequentially if needed and the length and other characteristics of the valve to be adjusted based on patient anatomy and condition.
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Citations
12 Claims
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1. A method for implanting a prosthetic aortic valve in a native aortic valve annulus location, said method comprising:
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providing a replacement aortic prosthetic valve having; a lower base portion comprising an inner tubular wall having a first height and comprising a balloon-expandable metal support scaffold covered with a material that inhibits paravalvular leakage and an outer tubular wall having a second height and comprising a self-expandable metal support scaffold covered with a material that inhibits paravalvular leakage, wherein the first height is greater than the second height and at least a portion of the inner tubular wall is disposed within the outer tubular wall and a separate upper valve portion comprising a lower engagement region and a balloon-expandable upper leaflet structure and wherein the outer tubular wall of the lower base portion is adapted to be expanded within a heart valve annulus and conform to the irregularities of shape of the heart valve annulus and the inner tubular wall is adapted to maintain a circular orientation after expansion; positioning the replacement aortic prosthetic valve in the native aortic valve location so that the lower base portion is located within the native aortic valve annulus and the lower engagement region of the upper valve portion is located within the inner tubular wall of the lower base portion such that the upper valve portion is located within or above the native aortic valve annulus; and simultaneously expanding the lower engagement region of the upper valve portion and the inner tubular wall such that the lower engagement region securely engages the inner tubular wall and expanding the upper leaflet structure such that the expanded upper leaflet structure assumes an increased cross-sectional area relative to the lower base portion. - View Dependent Claims (2, 3, 4)
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5. A prosthetic aortic heart valve comprising:
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an expandable lower base portion comprising a balloon-expandable inner tubular wall having a first height and comprising an expandable metal support scaffold covered with a material that inhibits paravalvular leakage and a self-expandable outer tubular wall having a second height and comprising an expandable metal support scaffold covered with a material that inhibits paravalvular leakage, wherein the first height is greater than the second height and at least a portion of the inner tubular wall is disposed within the outer tubular wall, and a separate upper valve portion comprising a lower engagement region and a balloon-expandable upper leaflet structure; wherein the outer tubular wall of the lower base portion is adapted to be expanded within a heart valve annulus and conform to the irregularities of shape of the heart valve annulus and the inner tubular wall is adapted to maintain a generally circular orientation after expansion, the lower engagement region of the upper valve portion is adapted to be expanded within the inner tubular wall of the lower base portion such that the lower engagement region securely engages the inner tubular wall and the upper leaflet structure is located above or within the heart valve annulus and such that the expanded upper leaflet structure may assume an increased cross-sectional area relative to the lower base portion. - View Dependent Claims (6, 7, 8, 9, 10, 11)
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12. A method for replacing a prosthetic aortic valve located in an aortic valve annulus, wherein the prosthetic aortic valve comprises a lower base portion comprising a balloon-expandable inner tubular wall having a first height and comprising an expandable metal support scaffold covered with a material that inhibits paravalvular leakage and a self-expandable outer tubular wall having a second height and comprising an expandable metal support scaffold covered with a material that inhibits paravalvular leakage, wherein the first height is greater than the second height and at least a portion of the inner tubular wall is disposed within the outer tubular wall and a separate upper valve portion comprising a lower engagement region and an upper leaflet structure, said method comprising:
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removing the upper valve portion from the lower base portion; positioning a replacement upper valve portion comprising a lower engagement region which is adapted to be expanded within the inner tubular wall of the lower base portion such that a lower engagement region of the replacement upper valve portion is located within the inner tubular wall of the lower base portion and securely engages the inner tubular wall and such that an upper leaflet structure of the replacement upper valve portion is located within or above the valve annulus and expanding the upper valve portion of the replacement aortic prosthetic valve so that the upper leaflet structure of the upper valve portion may be enlarged relative to the lower base portion.
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Specification