Method and apparatus for repairing a heart valve
Inventors
Miller, Eran • Cabiri, Oz • Gross, Yosef • GROSS, AMIR • Reich, Tal
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12350149-B2
Publication Date
2025-07-08
Expiration Date
2029-05-04
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Abstract
An implantable prosthetic device for repairing a native valve includes a first clip, a second clip, a first cord, and a second cord. The first clip has a first arm and a second arm and is moveable between an open position and a closed position. The second clip has a third arm and a fourth arm and is moveable between an open position and a closed position. The first cord is operatively coupled to the first clip for moving the first clip between the open and closed position. The second cord is operatively coupled to the second clip for moving the second clip between the open and closed position. The device is configured to clamp a first leaflet of the native mitral valve between the first arm and the second arm and to clamp a second leaflet of the native mitral valve between the third arm and the fourth arm.
Core Innovation
The invention provides an implantable prosthetic device for repairing a native valve, specifically the native mitral valve, of a heart. The device includes two clips, each having two arms pivotably coupled and movable between an open and closed position. Each clip is operatively coupled to a respective cord that moves the clip between these positions. The device is designed to clamp a first leaflet of the native mitral valve between the first and second arms of the first clip and a second leaflet between the third and fourth arms of the second clip.
The clips engage the leaflets on respective atrial and ventricular sides, thus securely connecting to portions of the leaflets while allowing relative movement between the portions of the leaflets to which the clips are connected during the natural cardiac cycle. This configuration enables the device to repair the valve by holding the leaflets in appropriate positions, improving valve function without impeding natural leaflet motion.
The problem being solved arises from mitral regurgitation caused by ischemic heart disease, which leads to dilation of the mitral valve annulus and displacement of papillary muscles, resulting in improper coaptation of the valve leaflets. This condition causes regurgitation of blood and weakens the left ventricle due to volume and pressure overloads. The invention addresses the need for a device that can repair native valve leaflets by clamping them securely while accommodating their natural motion, thereby overcoming issues associated with the annulus dilation and leaflet malcoaptation.
Claims Coverage
The patent includes multiple independent claims that cover the implantable prosthetic device for native mitral valve repair, with inventive features related to the structure and function of the clips and their cords, and their interaction with valve leaflets.
Dual clip system for mitral valve leaflet clamping
An implantable device comprising a first and second clip, each having pivotably coupled arms and moveable between open and closed positions, configured to clamp first and second native mitral valve leaflets between respective arms.
Operative cords controlling clip movement
First and second cords operatively coupled to the first and second clips, respectively, for moving each clip between the open and closed positions, enabling controlled clamping of the leaflets.
Asymmetric engagement of leaflets by clip arms
Each clip's arms are configured such that one arm engages the atrial side and the other engages the ventricular side of a respective mitral valve leaflet to clamp the leaflet securely.
Relative movement allowance between connected leaflets
The first and second clips are moveable with respect to one another allowing the portions of the first and second leaflets connected to the clips to move relative to each other during the natural cardiac cycle.
Clip features enhancing leaflet engagement
The first clip includes at least one coupling protrusion on one or both arms that may puncture the leaflet to enhance secure attachment, and the clip is biased toward the closed position, with movement from closed to open controlled by tension on the cord.
Spacer for clip support and leaflet spacing
An optional spacer positioned between the first and second leaflets supporting the first and second clips, enabling proper spacing and function.
Clip placement distinct from valve annulus
The first clip is spaced apart from the annulus of the native mitral valve when connected to the leaflet, allowing repair without interference at the annulus.
Clip connection to leaflet free edge
The first clip is connected to a free end of the first mitral valve leaflet, facilitating effective leaflet clamping.
The independent claims collectively cover an implantable device featuring two pivotable clips each controlled by cords to clamp respective mitral valve leaflets asymmetrically on atrial and ventricular sides, permitting natural leaflet motion, featuring securing protrusions, biasing toward closure, optional spacers, and specific positioning relative to the valve anatomy.
Stated Advantages
Enables secure clamping of mitral valve leaflets to restore valve function while permitting natural leaflet movement during the cardiac cycle.
Allows relative movement of the leaflets connected by the device, preserving physiological valve dynamics.
Provides adjustable control over clip opening and closing via cords to facilitate implantation and adjustment.
Spacing clips apart from the valve annulus avoids interference with annular structures.
Utilizes protrusions to enhance secure leaflet attachment, reducing risk of device displacement.
Documented Applications
Repair of native mitral valve leaflets affected by mitral regurgitation to restore coaptation and improve valve function.
Implantation in a patient's heart to clamp first and second leaflets of the native mitral valve during open-heart, minimally invasive, or transcatheter procedures.
Use in heart valve repair to address issues arising from ischemic heart disease, left ventricular dilatation, and leaflet malposition.
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