Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Annuloplasty device
Reexamination Certificate
1997-12-17
2001-12-25
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Annuloplasty device
C623S002410, C623S002100
Reexamination Certificate
active
06332893
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention pertains generally to the field of heart valve repair. More specifically, the present invention pertains to a device and method for the reduction of myocardial wall tension and the repair of mitral valve insufficiency.
Dilated cardiomyopathy is often accompanied by mitral valve insufficiency. There are several reasons for the presence of mitral valve insufficiency associated with a dilated heart. First, chamber dilation and associated high wall stresses increase the diameter of the mitral valve annulus. Additionally, as the heart dilates, the positioning of the papillary muscles is altered. Papillary muscles and chordae in a dilated heart will have moved both radially away and down from the mitral valve. This rearrangement of the vascular apparatus and enlargement of the annulus prevent the valve from closing properly.
Currently mitral valve insufficiency is treated by either repairing or replacing the valve. Surgical procedures used to repair the valve including ring posterior annuloplasty which consists of sewing a C or D-shaped ring around the posterior leaflet of the mitral valve and drawing in the annulus, reducing its previously enlarged diameter. Another method is to approximate the anterior and posterior mitral leaflets (Alfieri repair) by placing one suture through the center of both leaflets. This gives the valve a figure 8-shaped appearance when the valve is opened. When the mitral valve is replaced, the original leaflets are removed and the chordae are cut. An artificial valve consists of mechanical or tissue leaflets suspended on struts attached to a metal stent, and is sutured into place on the mitral annulus.
It has been argued that valve repair is preferable to valve replacement if the leaflet-chordae-papillary connections can be maintained. Heart wall stress will increase if the chordae are cut during valve replacement. It has been shown that by severing the chordae there can be 30 percent (30%) reduction in chamber function. Mitral valve replacement has high mortality in very sick, chronic heart failure patients.
SUMMARY OF THE INVENTION
The present invention pertains to a device and method for mitral valve repair. The mitral valve is generally defined as its leaflets or cusps, but in reality, it actually consists of the entire left ventricle chamber. By creating an improved chamber geometry, both chamber and valve function will be improved. The device of the present invention and method for valve repair/replacement can include treatment for chronic heart failure by reducing left ventricular wall tension.
In one embodiment of the present invention, the valve repair device includes an elongate tension member having a first end and second end. The basal anchor is disposed at the first end and the secondary anchor is disposed at the second end.
The basal anchor could include a pad and annuloplasty ring or the like. Alternately an artificial heart valve could serve as the basal anchor.
Tension members can be substantially rigid or substantially flexible. The secondary anchor can include a hook-shaped papillary muscle tissue loop, screw-shaped tissue anchor or transmural anchor pad.
The method of the present invention providing a tension member having a first end and a second end. The tension member has a basal anchor at the first end and a secondary anchor at the second end. The basal anchor is anchored proximate to the valve such that the tension member is disposed in the chamber. The secondary anchor is anchored to a portion of the heart spaced from the basal anchor such that the tension member is under tension and the geometry of the chamber has been altered by placement of the tension member.
The basal anchor can include an artificial heart valve, annuloplasty ring or the like. The secondary anchor can be anchored to a papillary muscle or transmurally anchored.
More than one tension member can be used. Additionally, a transverse tension member can be placed across the chamber generally perpendicular to the other tension members to further alter the geometry of the heart, reducing wall stress and improving chamber performance.
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Mortier Todd J.
Schweich, Jr. Cyril J.
Finnegan Henderson Farabow Garrett & Dunner LLP
Myocor, Inc.
Willse David H.
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