Apparatus and method for heart valve repair

A device for transcatheter gathering of tissue of a heart valve leaflet, the device comprising:

• an elongated tube extending in a longitudinal direction;
• a capture tool moveable in the tube between a retracted position and an extended position;
• a tissue support located within a distal portion of the tube;
• a clamping member pivotable in the tube between an open position spaced from the tissue support and a closed position adjacent the tissue support, the capture tool and the clamping member being operable to gather and clamp tissue of the heart valve leaflet between the tissue support and the clamping member, such that the clamped tissue has a gathered configuration;
• a releasable clip adapted to be applied to the clamped tissue for holding the clamped tissue in the gathered configuration;
• a retaining arm moveable between a distal position for retaining the clip and a proximal position for releasing the clip for application to the clamped tissue;
• and
• an operating handle having a distal portion that is affixed to the elongated tube and a proximal portion that is rotatable relative to the distal portion about a longitudinal axis of the handle.

A transcatheter method of gathering tissue of first and second heart valve leaflets, the method comprising:

• inserting an elongated catheter assembly to a position adjacent the first heart valve leaflet, the catheter assembly extending from an operating handle in a longitudinal direction and including a capture tool moveable between a retracted position and an extended position, a tissue support, a clamping member pivotable between an open position spaced from the tissue support and a closed position adjacent the tissue support, and a retaining arm moveable between a distal position for retaining two clips and a proximal position for releasing the clips, the operating handle having a distal portion that is affixed to the catheter assembly and a proximal portion that is rotatable relative to the distal portion about a longitudinal axis of the handle;
• moving the capture tool from the retracted position to the extended position;
• pivoting the clamping member from the closed position to the open position adjacent the first heart valve leaflet, such that a distal portion of the clamping member moves laterally away from the tissue support in a direction transverse to the longitudinal direction;
• manipulating the catheter assembly so that tissue of the first heart valve leaflet is positioned between the tissue support and the clamping member;
• partially retracting the capture tool from the extended position toward the retracted position to gather an additional amount of tissue of the first heart valve leaflet between the tissue support and the clamping member;
• pivoting the clamping member from the open position toward the closed position so as to clamp a substantial portion of the gathered tissue of the first heart valve leaflet between the tissue support and the clamping member, such that the distal portion of the clamping member moves laterally toward the tissue support in the direction transverse to the longitudinal direction, the clamped tissue having a gathered configuration;
• moving the retaining arm from the distal position to an intermediate position to apply a first one of the clips from the catheter assembly to the clamped tissue so as to hold the clamped tissue substantially in the gathered configuration;
• rotating the catheter assembly and the distal portion of the operating handle relative to the proximal portion of the operating handle;
• and
• moving the retaining arm from the intermediate position to the proximal position to apply a second one of the clips from the catheter assembly to the tissue of the second heart valve leaflet.

A transcatheter method of gathering tissue of a heart valve leaflet, the method comprising:

• inserting an elongated catheter assembly to a position adjacent the heart valve leaflet, the catheter assembly extending in a longitudinal direction and including a capture tool moveable between a retracted position and an extended position, a tissue support, a clamping member pivotable between an open position spaced from the tissue support and a closed position adjacent the tissue support, and a retaining arm moveable between a distal position for retaining two clips and a proximal position for releasing the clips;
• moving the capture tool from the retracted position to the extended position;
• pivoting the clamping member from the closed position to the open position adjacent the heart valve leaflet, such that a distal portion of the clamping member moves laterally away from the tissue support in a direction transverse to the longitudinal direction;
• manipulating the catheter assembly so that tissue of the heart valve leaflet is positioned between the tissue support and the clamping member;
• partially retracting the capture tool from the extended position toward the retracted position to gather an additional amount of tissue of the heart valve leaflet between the tissue support and the clamping member;
• pivoting the clamping member from the open position toward the closed position so as to clamp a substantial portion of the gathered tissue of the heart valve leaflet between the tissue support and the clamping member, such that the distal portion of the clamping member moves laterally toward the tissue support in the direction transverse to the longitudinal direction, the clamped tissue having a gathered configuration;
• moving the retaining arm from the distal position to an intermediate position to apply a first one of the clips from the catheter assembly to the clamped tissue so as to hold the clamped tissue substantially in the gathered configuration;
• and
• moving the retaining arm from the intermediate position to the proximal position to apply a second one of the clips from the catheter assembly to the clamped tissue.