Gripper pusher mechanism for tissue apposition systems

Patent metadata

Field	Value
Publication number	US-10624640-B2
Application number	US-201414575024-A
Country	US
Kind code	B2
Filing date	Dec 18, 2014
Priority date	Sep 13, 2011
Publication date	Apr 21, 2020
Grant date	Apr 21, 2020

Abstract

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

First claim

What is claimed is:

1. A system for fixing the relative position of at least two heart valve leaflets, said system comprising:
a catheter having a proximal end and a distal end;
a shaft extending from the distal end of the catheter;
an implantable leaflet fixation device removeably attached to a distal end of the shaft, the implantable leaflet fixation device comprising a pair of fixation elements each having a first end, a second end opposite the first end, and an engagement surface therebetween for engaging leaflets, the fixation device further comprising a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture at least a part of the leaflet therebetween; and
a gripper pusher adjacent the pair of gripping elements, the gripper pusher having an expanded configuration and a collapsed configuration, wherein by expansion of the gripper pusher towards the expanded configuration, the gripper pusher engages the pair of gripping elements and advances the pair of gripping elements toward the engagement surfaces of the fixation elements, and wherein in the collapsed configuration the gripper pusher has a reduced radial profile relative to the gripper pusher radial profile in the expanded configuration thereby allowing the pair of gripping elements to move away from the engagement surfaces of the fixation elements.

2. The system of claim 1 , wherein the first ends are movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to an inverted position wherein the engagement surfaces face away from each other.

3. The system of claim 2 , further comprising an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position.

4. The system of claim 1 , wherein each fixation element is at least partially concave such that each gripping element is separated from an opposing engagement surface in an undeployed configuration, and each gripping element is at least partially recessed within the fixation element in a deployed configuration.

5. The system of claim 2 , wherein the fixation elements are further moveable to an open position between the closed position and the inverted position.

6. The system of claim 1 , wherein the gripping elements are movable independently of the fixation elements.

7. The system of claim 1 , wherein the gripping elements are biased toward the engagement surfaces.

8. The system of claim 1 , wherein the gripping elements are approximately parallel to each other in an undeployed configuration.

9. The system of claim 1 , wherein the gripper pusher comprises a spring element that moves from the collapsed configuration to the expanded configuration when a compressive force is applied thereto.

10. The system of claim 9 , wherein the spring element comprises a longitudinal axis, and the compressive force is applied in a direction substantially parallel thereto.

11. The system of claim 9 , wherein the spring element is resiliently biased to return to the collapsed configuration when the compressive force is released.

12. The system of claim 9 , wherein the gripper pusher comprises two spring elements.

13. The system of claim 1 , wherein the gripper pusher comprises an elongate deflectable arm.

14. The system of claim 13 , wherein the deflectable arm is biased to return to the expanded configuration.

15. The system of claim 14 , wherein proximal retraction of the proximal elements collapses the deflectable arm from the expanded configuration to the collapsed configuration.

16. The system of claim 1 , wherein the gripper pusher comprises an attachment mechanism for releasably attaching a distal portion of the gripper pusher to the implantable fixation device.

17. The system of claim 16 , wherein the attachment mechanism comprises a notched region on the distal portion of the gripper pusher, and a boss adjacent a proximal end of the implantable fixation device, wherein the notched region is sized to accept the boss.

18. The system of claim 1 , wherein the gripper pusher having a pair of straight regions each connected to one of bowed regions, the bowed regions are configured to deflect radially outward to contact a corresponding gripping element in the expanded configuration and are released from the contact in the collapsed configuration.

19. The system of claim 18 , wherein the gripper pusher comprises an attachment ring coupled to a proximal portion thereof, the attachment ring slidably disposed over the delivery shaft.

20. The system of claim 1 , further comprising a coupling member for detachably coupling the fixation device to the shaft.

21. The system of claim 1 , further comprising a covering on the fixation elements adapted for promoting tissue growth.

22. The system of claim 1 , further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

23. The system of claim 1 , wherein the gripper pusher is configured to be expanded into the expanded configuration from the collapsed configuration by sliding a proximal portion of the gripper pusher distally relative to the shaft while a distal portion of the gripper pusher is fixed relative to the shaft.

24. A system for fixing the relative position of at least two heart valve leaflets, said system comprising:
a catheter having a proximal end and a distal end;
a shaft extending from the distal end of the catheter;
an implantable leaflet fixation device removeably attached to a distal end of the shaft, the implantable leaflet fixation device comprising a pair of fixation elements each having a first end, a second end opposite the first end, and an engagement surface therebetween for engaging leaflets, the fixation device further comprising a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture at least a part of the leaflet therebetween; and
a gripper pusher adjacent the pair of gripping elements, the gripper pusher having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the gripper pusher directly engages the pair of gripping elements and advances the pair of gripping elements toward the engagement surfaces of the fixation elements, and wherein in the collapsed configuration the gripper pusher has a reduced radial profile relative to the gripper pusher radial profile in the expanded configuration thereby allowing the pair of gripping elements to move away from the engagement surfaces of the fixation elements.

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Dell Kent
• Ketai Theodore
• Mishra Tanmay
• Jones Stephanie
• Greenberg Jacob
• Hong Michael
• Hale Daniel
• Valencia Francisco
• Tyler Steven

Classifications

• A61B2017/00243

  cardiac · CPC title

• A61F2/2454

  Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title

• A61B17/10

  for applying or removing wound clamps {, e.g. containing only one clamp or staple (A61B17/076 takes precedence; containing multiple wound clamps A61B17/068)}; Wound clamp magazines · CPC title

• A61B17/08 Primary

  Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound} · CPC title