Systems and Methods For Placement of Valve Prosthesis System

Abstract

Valve prosthesis systems and methods / systems for placement of such valve prostheses are provided that facilitate efficient, reliable and minimally invasive delivery modalities. The placement systems and methods permit remote manipulation and positioning of the valve prosthesis such that desirable placement relative to anatomical structures, e.g., the heart annulus, may be achieved. The valve prosthesis includes a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. The delivery system includes a first elongate element that terminates at the valve prosthesis and is manipulable by an operator to remotely rotate the positioning elements relative to the flexible ring. A second elongate element terminates at the valve prosthesis and is manipulable by an operator to remotely advance the valve prosthesis downward into an anatomical annulus. The second elongate element may be manipulated to remotely advance the valve prosthesis into the anatomical annulus to assume a position for supporting post-implantation function of the valve prosthesis in situ. The first elongate element may be further manipulated to remotely rotate the positioning element relative to the flexible ring to cause the positioning element to engage tissue associated with the anatomical annulus and to thereby maintain the post-implantation position of the valve prosthesis in situ. Methods for valve prosthesis deployment are also provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims the benefit of co-pending provisional patent application entitled “Valve Prosthesis System” that was filed on Feb. 23, 2007 and assigned Ser. No. 60 / 902,988. The entire contents of the foregoing provisional application are incorporated herein by reference.BACKGROUND[0002]1. Technical Field[0003]The present disclosure is directed to advantageous valve prosthesis systems and associated methods / systems for placement of a heart valve prosthesis and, more particularly, to deployment systems and methods for placement of a mitral valve prosthesis relative to a heart annulus.[0004]2. Background Art[0005]Heart valve regurgitation occurs when the heart valve does not close completely as a result of disease or injury. Mitral regurgitation due to ischemic and degenerative (prolapse) disease has been shown to contribute to left ventricular dilation and dysfunction due to remodeling, and is associated with increased rates...

AI Technical Summary

Benefits of technology

[0015]Valve prosthesis systems and methods / systems for placement of such valve prostheses are disclosed herein. Exemplary deployment systems and methods for placement of a mitral valve prosthesis relative to a heart annulus are disclosed that facilitate efficient, reliable and minimally invasive delivery modalities. The disclosed systems and methods permit remote manipulation and positioning of the valve prosthesis such that desirable placement relative to anatomical structures, e.g., the heart annulus, may be achieved.

[0024]Exemplary embodiments of the present disclosure further provide a tool for facilitating percutaneous delivery of a valve prosthesis to an anatomical location. Exemplary tools include a body defining a longitudinal axis, a distal end disposed on the longitudinal axis, and a proximal end disposed on the longitudinal axis opposite the distal end A first actuator may be mounted with respect to the body at one of the distal end thereof and the proximal end thereof The first actuator is generally configured to receive and engage a first elongate element manipulable to remotely rotate a positioning element associated with a valve prosthesis. The first actuator is also generally reciprocally actuatable with respect to the body for manipulating the first elongate element by causing the first elongate element to translate with respect to a delivery tube along the longitudinal axis.

Problems solved by technology

Mitral regurgitation due to ischemic and degenerative (prolapse) disease has been shown to contribute to left ventricular dilation and dysfunction due to remodeling, and is associated with increased rates of cardiac events and death.

Currently, malfunctioning heart valves may be replaced with biologic or mechanical prostheses through open-heart surgery with the attendant significant risk of death, stroke, infection, bleeding, and complications due to the use of general anesthesia and cardiopulmonary bypass.

Such a design is not amenable to placement of the heart valve prosthesis at the location of the biologic valve.

It is also difficult to position these designs as one has to inflate a balloon in a moving column of blood while the heart is beating and one only gets one chance to accurately deploy it.

An additional difficulty occurs when deploying a stented heart valve in an annulus that is not thickened by calcium.

However, when calcium is not present, as in other causes of aortic valve disease and in the mitral position, the stent may be difficult to anchor on the relatively thin annulus.

Furthermore, the nature by which the stent folds on a balloon and then expands with plastic deformability limits the ratio of its initial to final size such that it will, by necessity, have a fairly large profile making percutaneous insertion via catheter more difficult in a valve annulus with a large diameter that has not been reduced by calcium deposition.

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