Percutaneous valve prosthesis and system and method for implanting same

Abstract

A heart valve prosthesis includes a cylindrical valve cage stent constructed to be implanted percutaneously in the planar axis of a native valve annulus, an elastic and compressible, multi-leaflet valve insertable percutaneously into the body, and an attachment mechanism for attaching the valve to the superior rim of the valve cage stent. The valve can be of a bi-leaflet or a tri-leaflet type and includes a valve frame made from a memory metal and a tissue cover attached to the valve frame. The valve cage stent is self-expanding or balloon expandable, made respectively from memory metal or stainless steel but otherwise structurally the same.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present patent application is based on, and claims priority from, U.S. provisional Application No. 60 / 833,791, filed Jul. 28, 2006, which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to heart valve prostheses, preferably to aortic valve prostheses. More specifically, the invention relates to heart valve prostheses that can be implanted percutaneously by means of a catheter from a remote Location without opening the chest cavity.[0004]2. Related Art[0005]Heart valve surgery is used to repair or replace diseased heart valves. Valve surgery is an open-heart procedure conducted under general anesthesia. An incision is made through the patient's sternum (sternotomy), and the patient's heart is stopped while blood flow is rerouted through a heart-lung bypass machine.[0006]Valve replacement may be indicated when there is a narrowing of the na...

AI Technical Summary

Benefits of technology

[0026]It is another object of this invention to provide maximal valve area to the out flow tract of the left ventricle, t

Problems solved by technology

Mechanical valves require lifelong anticoagulant medication to prevent clot formation around the valve, which can lead to thromboembolic complications and catastrophic valve failure.

Valve replacement surgery is a highly invasive operation with significant concomitant risk.

Risks include bleeding, infection, stroke, heart attack, arrhythmia, renal failure, and adverse reactions to the anesthesia medications, as well as sudden death.

PVT's device suffers from several drawbacks.

Deployment of PVT's stent has several drawbacks, including that there is very little control over its deployment.

This lack of control can endanger the coronary ostea above the aortic valve and the anterior leaflet of the mitral valve below the aortic valve.

Another drawback of the PVT device is its relatively large cross-sectional delivery profile.

Considering they have to be durable, the materials for the valve and the stent are very bulky, thus increasing the profile of the device.

The PVT system's stent/valve combination is mounted onto a delivery balloon, making retrograde delivery through the aorta challenging.

An antegrade transseptal approach may therefore be needed, requiring puncture of the septum and routing through the mitral valve, which significantly increases complexity and risk of the procedure.

Very few cardiologists are currently trained in performing a transseptal puncture, which is a challenging procedure by itself.

Another drawback of the PVT device is its lack of fixation provision.

For this to work, sufficient dilatation of the valve area has to be achieved; but this amount of dilation can cause damage to the annulus.

Also, due to its inability to have an active fixation mechanism, the PVT device cannot be used to treat aortic regurgitation.

Another drawback to this system is that it does not address the leakage of blood around the implant, after its implantation.

Standard self-expanding systems have very poor accuracy in deployment, however.

It is therefore often impossible to know where the ends of the s

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