SYSTEMS AND METHODS FOR PLACING A COAPTING MEMBER BETWEEN VALVULAR LEAFLETS
First Claim
1. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:
- advancing a ventricular anchor on the distal end of a flexible rail from above the native tricuspid annulus into the right ventricle;
anchoring the ventricular anchor within the right ventricle;
advancing a coaptation member on a distal end of a delivery catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets;
adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve;
locking the position of the delivery catheter relative to the flexible rail by clamping a locking collet carried by the catheter onto the flexible rail; and
subcutaneously securing the locking collet outside the subclavian vein.
1 Assignment
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Accused Products
Abstract
The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.
268 Citations
21 Claims
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1. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:
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advancing a ventricular anchor on the distal end of a flexible rail from above the native tricuspid annulus into the right ventricle; anchoring the ventricular anchor within the right ventricle; advancing a coaptation member on a distal end of a delivery catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets; adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve; locking the position of the delivery catheter relative to the flexible rail by clamping a locking collet carried by the catheter onto the flexible rail; and subcutaneously securing the locking collet outside the subclavian vein. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:
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advancing a ventricular anchor on the distal end of a flexible rail from above the native tricuspid annulus into the right ventricle; advancing a catheter having a balloon thereon over the flexible rail until the balloon is positioned substantially within the tricuspid heart valve leaflets; inflating the balloon on the accessory catheter to center the flexible rail within the tricuspid annulus; further advancing the flexible rail until the ventricular anchor is located approximately at the apex of the right ventricle, and anchoring the ventricular anchor within the right ventricle; advancing a coaptation member on a catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets; adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve; and locking the position of the coaptation member relative to the flexible rail. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15)
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16. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:
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advancing a ventricular anchor on the distal end of a flexible rail from above the native tricuspid annulus into the right ventricle; anchoring the ventricular anchor within the right ventricle; advancing a coaptation member on a distal end of a delivery catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets; securing the coaptation member on the delivery catheter to a point above the tricuspid annulus and within a direct line to the tricuspid annulus; adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve; and locking the position of the delivery catheter relative to the flexible rail. - View Dependent Claims (17, 18, 19, 20, 21)
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Specification