System for fixation of leaflets of a heart valve

Patent metadata

Field	Value
Publication number	US-10743876-B2
Application number	US-201916540285-A
Country	US
Kind code	B2
Filing date	Aug 14, 2019
Priority date	Sep 13, 2011
Publication date	Aug 18, 2020
Grant date	Aug 18, 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 fixation of leaflets of a heart valve comprising:
an implantable fixation device comprising
a first arm and a second arm,
a first proximal element moveable relative to the first arm between a first position and a second position, and
a second proximal element moveable relative to the second arm between a first position and a second position; and

a delivery device comprising
a delivery catheter having a proximal end portion and a distal end portion, the delivery catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element line extending through the at least one lumen, the first proximal element line releasably coupled to the first proximal element and actuatable to move the first proximal element between the first position and the second position,
a second proximal element line extending through the at least one lumen, the second proximal element line releasably coupled to the second proximal element and actuatable to move the second proximal element between the first position and the second position, and
a handle having
a first proximal element line handle coupled to and actuatable to deploy the first proximal element line to move the first proximal element between the first position and the second position, and
a second proximal line handle coupled to and actuatable to deploy the second proximal element line to move the second proximal element between the first position and the second position;

wherein the first and second proximal element line handles are adjacent each other and aligned in parallel and configured to be gripped independently or jointly to move the first proximal element and the second proximal element independently or simultaneously.

2. The fixation system of claim 1 , wherein the handle further comprises a first stop to limit a distance in which each of the first proximal element line handle and the second proximal element line handle can be moved in a first direction.

3. The fixation system of claim 2 , wherein the handle further comprises a second stop to limit a distance in which each of the first proximal element line handle and the second proximal element line handle can move in a second direction.

4. The fixation system of claim 1 , wherein the at least one lumen includes at least a first proximal element line lumen and a second proximal element line lumen.

5. The fixation system of claim 1 , wherein the first proximal element line comprises one of suture, wire, nitinol wire, rod, cable, and polymeric line.

6. The fixation system of claim 5 , wherein the second proximal element line comprises one of suture, wire, nitinol wire, rod, cable, and polymeric line.

7. The fixation system of claim 1 , wherein the first proximal element line comprises a first end portion, a second end portion, and an intermediate portion between the first end portion and the second end portion, and wherein the first proximal element line is coupled to the first proximal element at the intermediate portion of the first proximal element line.

8. The fixation system of claim 7 , wherein the second proximal element line comprises a first end portion, a second end portion, and an intermediate portion between the first end portion and the second end portion, and wherein the second proximal element line is coupled to the second proximal element at the intermediate portion of the second proximal element line.

9. The fixation system of claim 1 , wherein the first proximal element comprises nitinol and the second proximal element comprises nitinol.

10. The fixation system of claim 1 , wherein the first proximal element is biased toward the first arm; and the second proximal element is biased toward the second arm.

11. The fixation system of claim 1 , wherein the delivery device further comprises a first guide catheter having a proximal end portion and a distal end portion, the first guide catheter defining at least one lumen extending between the proximal end portion and the distal end portion, and wherein the delivery catheter extends within the lumen of the first guide catheter.

12. The fixation system of claim 11 , wherein the delivery device further comprises a second guide catheter having a proximal end portion and a distal end portion, the second guide catheter defining at least one lumen extending between the proximal end portion and the distal end portion, and wherein the first guide catheter extends within the lumen of the second guide catheter.

13. The fixation system of claim 12 , wherein the first guide catheter is a steerable guide catheter.

14. The fixation system of claim 13 , wherein the first guide catheter comprises a first guide catheter handle coupled to the proximal end portion of the first guide catheter and actuatable to deflect the distal end portion of the first guide catheter.

15. The fixation system of claim 14 , wherein the first guide catheter handle comprises at least one first guide catheter steering knob, wherein the first guide catheter handle is actuated by rotating the at least one first guide catheter steering knob.

16. The fixation system of claim 12 , wherein the second guide catheter is a steerable guide catheter.

17. The fixation system of claim 16 , wherein the second guide catheter comprises a second guide catheter handle coupled to the proximal end portion of the second guide catheter and actuatable to deflect the distal end portion of the second guide catheter.

18. The fixation system of claim 17 , wherein the second guide catheter handle comprises at least one second guide catheter steering knob, wherein the second guide catheter handle is actuated by rotating the at least one second guide catheter steering knob.

19. The fixation system of claim 12 , wherein the first guide catheter and the second guide catheter form a guiding catheter system.

20. The fixation system of claim 12 , wherein the distal end portion of the second guide catheter has an outer diameter of less than about 0.500 in.

21. The fixation system of claim 1 , wherein the first proximal element line handle includes a first finger grip and the second proximal element line handle includes a second finger grip.

22. The fixation system of claim 21 , wherein the first finger grip comprises a first contoured surface and the second finger grip comprises a second contoured surface.

23. The fixation system of claim 21 , where the first finger grip comprises a first plurality of ridges and the second finger grip comprises a second plurality of ridges.

24. The fixation system of claim 1 , wherein the first proximal element line handle and the second proximal element line handle are disposed on a first side of the handle.

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

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · 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

• A61B17/083 Primary

  Clips, e.g. resilient · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/2454

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