Adjustable prosthetic valve implant

Abstract

A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element. The at least one adjustable element may engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient's left ventricle, when the at least one adjustable element is in the second configuration.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60 / 751,036, filed on Dec. 16, 2005, and titled “ADJUSTABLE PROSTHETIC VALVE IMPLANT,” the entirety of which is hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to methods and devices for reinforcing dysfunctional heart valves and other body structures. More specifically, embodiments of the present invention relates to using an aortic valve prosthesis to treat a diseased aortic valve annulus. [0004] 2. Description of the Related Art [0005] The circulatory system of mammals includes the heart and the interconnecting vessels throughout the body that include both veins and arteries. The human heart includes four chambers, which are the left and right atrium and the left and right ventricles. The mitral valve, which allows blood flow in one direction, is posi...

AI Technical Summary

Benefits of technology

[0011] A need, therefore, remains for improved technology, which allows a device to be transluminally introduced, advanced into the region of the cardiac valve annulus, and implanted over the pathological natural valve. In certain embodiments, the device would be able to be guided by fluoroscopy, MRI or ultrasound. Certain embodiments would further allow for adjustment in size should perivalvular or paravalvular leakage be detected. Certain embodiments would further possess the capability for adjustment, both radially inward and radially outward, using non-surgical methodology.

Problems solved by technology

If the valves of the heart do not function properly, due either to disease or congenital defects, the circulation of the blood may be compromised.

Diseased heart valves may be stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and / or incompetent, wherein the valve does not close completely.

Incompetent heart valves cause regurgitation or excessive backward flow of blood through the valve when the valve is closed.

When a heart valve annulus dilates, the valve leaflet geometry deforms and causes ineffective closure of the valve leaflets.

The ineffective closure of the valve can cause regurgitation of the blood, accumulation of blood in the heart, and other problems.

Although surgical valve replacement concerns about 200,000 patients worldwide every year, it is estimated that up to two thirds of these patients do not receive surgery due to either excessive risk factors and comorbidities or patient refusal due to fear of lifestyle changes following heavy surgery in elderly patients.

Although a number of minimally invasive techniques for replacing heart valves do exist, they are often problematic.

For example, with many minimally invasive valve replacements, paravalvular leaks can occur, with moderate to severe leakage occurring in 25% of cases.

These calcified lesions are extremely difficult to remove without fragmentation and without leaving some pieces of calcium, which may migrate and embolize.

Accurate and secure deployment of the valve prostheses will remain a significant issue for these endovascular procedures.

The resultant paravalvular leak is somewhat unpredictable at the time of the implantation.

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