APPARATUS AND METHOD FOR HEART VALVE REPAIR

• US 20140114403A1
• Filed: 03/08/2013
• Published: 04/24/2014
• Est. Priority Date: 10/19/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories), St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Dale, Theodore Paul, Olson, Richard J., Morris, Benjamin E., Miser, John, Nadein, Aleksandr I.
• Granted Patent: US 9,066,710 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00353 one mechanical instrument performing multiple functions, e.g. cutting and grasping
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A device for transcatheter gathering of tissue of a heart valve leaflet may include an elongated tube, 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, and 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 clamping member may have a flattened clamping portion and a C-shaped portion that defines a pocket therein. An open side of the C-shaped portion may face the tissue support. The capture tool and the clamping member may be operable to gather and clamp tissue between the tissue support and the clamping member, such that the clamped tissue has a gathered configuration. The device may also include a releasable clip adapted to hold the clamped tissue in the gathered configuration.

Claims

1. 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 clamping member having a flattened clamping portion and a C-shaped portion that defines a pocket therein, an open side of the C-shaped portion facing 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; and

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.

2. The device of claim 1, wherein a distal portion of the clamping member has a fork shape.

3. The device of claim 2, wherein the distal portion of the clamping member has two tines having respective ends that are spaced apart from one another by an internal gap.

4. The device of claim 1, further comprising an operating handle having an actuating member adapted to control pivoting of the clamping member between the open and closed positions.

5. The device of claim 1, wherein the device includes two releasable clips adapted to be applied to the clamped tissue for holding the clamped tissue in the gathered configuration, and wherein each clip is biased from an open condition to a clamping condition, the retaining arm in the distal position holds the clips in the open condition, and the retaining arm in the proximal position releases the clips for application to the clamped tissue.

6. The device of claim 5, wherein the tissue support includes first, second, and third bodies spaced apart in the longitudinal direction, and wherein, when the clips are held in the open condition by the retaining arm, a first one of the clips is located between the first and second bodies, and a second one of the clips is located between the second and third bodies.

7. The device of claim 5, wherein movement of the retaining arm from the distal position to an intermediate position releases a first one of the clips, and wherein movement of the retaining arm from the intermediate position to the proximal position releases a second one of the clips.

8. The device of claim 1, further comprising an operating handle having an actuating member adapted to control movement of the retaining arm between the distal position and the proximal position.

9. The device of claim 8, wherein the device includes two releasable clips adapted to be applied to the clamped tissue for holding the clamped tissue in the gathered configuration, and wherein a first actuation of the actuating member moves the actuating member from the distal position to an intermediate position to release a first one of the clips, and a second actuation of the actuating member moves the actuating member from the intermediate position to the proximal position to release a second one of the clips.

10. The device of claim 1, wherein the capture tool includes a grasping wire slidably disposed in a containment tube, and wherein a distal portion of the grasping wire is adapted to change from a linear shape to a hook shape when the distal portion of the grasping wire is extended out from the containment tube.

11. 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.

12. The device of claim 11, wherein the operating handle has an actuating member movable between a first position and a second position, the proximal portion of the operating handle being rotationally locked to the distal portion of the operating handle when the actuating member is in the first position, and the proximal portion of the operating handle being released for rotation relative to the distal portion of the operating handle when the actuating member is in the second position.

13. The device of claim 12, wherein the actuating member includes a spring element that biases the actuating member to the first position.

14. The device of claim 11, wherein the device includes two releasable clips adapted to be applied to the clamped tissue for holding the clamped tissue in the gathered configuration, and wherein movement of the retaining arm from the distal position to an intermediate position releases a first one of the clips, and wherein movement of the retaining arm from the intermediate position to the proximal position releases a second one of the clips.

15. 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.

16. The method of claim 15, wherein each clip is biased from an open condition to a clamping condition and the retaining arm holds the clips in the open condition, and wherein the step of moving the retaining arm from the distal position to the proximal position releases the clips for movement to the clamping condition.

17. The method of claim 15, wherein the operating handle having an actuating member moveable in opposite directions, and wherein the step of pivoting the clamping member from the closed position to the open position includes moving the actuating member in a first one of the opposite directions.

18. 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.

19. The method of claim 18, wherein the catheter assembly further includes an operating handle having an actuating member actuatable in a first direction, wherein the step of moving the retaining arm from the distal position to the intermediate position is performed by actuating the actuating member a first time, and wherein the step of moving the retaining arm from the intermediate position to the proximal position is performed by actuating the actuating member a second time.

20. The method of claim 18, wherein the capture tool includes a grasping wire slidably disposed in a containment tube, the method further comprising sliding a distal portion of the grasping wire out from the containment tube so that the distal portion of the grasping wire changes from a linear shape to a hook shape.