ADJUSTABLE TETHER AND EPICARDIAL PAD SYSTEM FOR PROSTHETIC HEART VALVE

• US 20150223934A1
• Filed: 02/11/2015
• Published: 08/13/2015
• Est. Priority Date: 02/11/2014
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: VIDLUND, Robert M., EKVALL, Craig A.
• Granted Patent: US 9,986,993 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Apparatus and methods are described herein for repositioning a tether attached to a prosthetic heart valve. In some embodiments, a method includes inserting a distal end portion of a snare device through an incision at a first location in a ventricular wall of a heart and within the left ventricle of the heart. A tether extending from a prosthetic mitral valve, through the left ventricle and out an incision at a second location on the ventricular wall of the heart is snared with the snare device. The tether is pulled with the snare device such that a proximal end of the tether is moved back through the incision at the second location on the ventricular wall and into the left ventricle. The snare device is pulled proximally such that the tether is pulled proximally through the incision at the first location in the ventricular wall of the heart.

Claims

1. A method, comprising:

inserting a distal end portion of a snare device through an incision at a first location in a ventricular wall of a heart of a patient and positioning a distal end of the snare device in the left ventricle of the heart;

snaring with the snare device a tether at least partially disposed within the left ventricle, the tether exiting the heart at an incision at a second location on the ventricular wall of the heart and extending from a prosthetic mitral valve implanted within a mitral annulus of the heart;

pulling the tether with the snare device such that a proximal end of the tether is moved back through the incision at the second location on the ventricular wall and into the left ventricle; and

pulling the snare device proximally, such that the snared tether is pulled proximally through the incision at the first location in the ventricular wall of the heart.

2. The method of claim 1, further comprising:

after the pulling the snare device, securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

3. The method of claim 1, further comprising:

after the pulling the snare device, adjusting a tension on the tether extending through the incision at the first location on the ventricular wall of the heart.

4. The method of claim 1, further comprising:

after the pulling the snare device, adjusting a tension on the tether extending through the incision at the first location on the ventricular wall of the heart; and

securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

5. The method of claim 1, further comprising:

prior to inserting the distal end portion of the snare device, inserting a catheter through an incision in the skin of the patient;

positioning a distal end portion of the catheter proximate to the first location on the ventricular wall of the heart; and

inserting the snare device through a lumen of the catheter until a distal end of the snare device exits a distal end of the catheter proximate to the first location on the ventricular wall of the heart.

6. The method of claim 1, further comprising:

prior to inserting the distal end portion of the snare device through the incision at the first location, inserting a delivery device through the incision at the second location in the ventricular wall, the delivery device including the prosthetic mitral valve coupled thereto; and

deploying the prosthetic mitral valve in the mitral annulus of the heart such that the tether extends from the prosthetic mitral valve and out through the incision at the second location in the ventricular wall of the heart.

7. A method, comprising:

inserting a distal end portion of a catheter through an incision at a first location in a ventricular wall of a heart, through a left ventricle of the heart and through an incision at a second location in the ventricular wall while a proximal end of the catheter remains outside the incision at the first location and such that a distal end portion of the catheter is disposed at least partially parallel to a tether extending through the incision at the second location in the ventricular wall, the tether coupled at a distal end to a prosthetic mitral valve implanted within the heart;

threading at least a proximal end portion of the tether through a lumen defined by the catheter until a proximal end of the tether extends out of a proximal end of the catheter outside of the heart; and

pulling the catheter proximally such that the distal end portion of the catheter extends within the left ventricle of the heart with the tether extending through the lumen of the catheter outside of the heart; and

adjusting a tension on the tether between the prosthetic mitral valve and the incision at the first location in the ventricular wall of the heart.

8. The method of claim 7, wherein:

the threading the tether includes moving a snare device distally through the lumen of the catheter until a distal end of the snare device exits the distal end of the catheter outside of the heart,

snaring with the snare device a portion of the tether extending outside of the heart; and

pulling the tether with the snare device into the lumen of the catheter and out a proximal end of the catheter outside of the heart.

9. The method of claim 7, wherein:

the threading the tether includes manually inserting the proximal end of the tether into the lumen of the catheter and threading the tether through the lumen of the catheter until the proximal end of the tether extends out the proximal end of the catheter outside of the heart.

10. The method of claim 7, further comprising:

securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

11. The method of claim 7, further comprising:

prior to the adjusting the tension on the tether, removing the catheter from the heart leaving the tether extending through the incision at the first location in the ventricular wall of the heart.

12. The method of claim 7, further comprising:

after the adjusting the tension on the tether, removing the catheter from the heart leaving the tether extending through the incision at the first location in the ventricular wall of the heart.

13. The method of claim 7, wherein the catheter is flexible such that the catheter can bend to extend between the incision at the first location in the ventricular wall of the heart and the incision at the second location in the ventricular wall of the heart.

14. The method of claim 7, wherein the catheter includes a bend formed in the catheter such that the catheter can extend between the incision at the first location in the ventricular wall of the heart and the incision at the second location in the ventricular wall of the heart.

15. A method, comprising:

inserting a distal end of a catheter through an incision at a first location in a ventricular wall of a heart, through a left ventricle of the heart and through the ventricular septum of the heart such that the distal end of the catheter is disposed within the right ventricle, a portion of the catheter extending through the incision at the first location with the proximal end of the catheter disposed outside the heart;

moving a snare device distally within a lumen of the catheter until a distal end of the snare device is disposed within the right ventricle;

snaring with the snare device a portion of a tether disposed within the right ventricle, the tether extending from a prosthetic tricuspid valve implanted within the heart, the tether extending through an incision at a second location in the ventricular wall of the heart with a proximal end of the tether disposed outside of the heart; and

pulling the tether with the snare device through the lumen of the catheter such that the proximal end of the tether is pulled out the proximal end of the catheter outside of the heart.

16. The method of claim 15, further comprising:

after the pulling the tether, adjusting a tension on the tether between the prosthetic tricuspid valve and the incision at the first location in the ventricular wall of the heart.

17. The method of claim 15, further comprising:

after the pulling the tether, removing the catheter from the heart leaving the tether extending through the incision at the first location in the ventricular wall of the heart.

18. The method of claim 15, further comprising:

after the pulling the tether, adjusting a tension on the tether between the prosthetic tricuspid valve and the incision at the first location in the ventricular wall of the heart; and

after the adjusting, removing the catheter from the heart leaving the tether extending through the incision at the first location in the ventricular wall of the heart.

19. The method of claim 15, further comprising:

securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

20. The method of claim 15, further comprising:

after the pulling the tether, adjusting a tension on the tether between the prosthetic tricuspid valve and the incision at the first location in the ventricular wall of the heart; and

securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

21. A method, comprising:

inserting a distal end portion of a catheter through an incision at a first location in a ventricular wall of a heart such that a distal end portion is disposed within a left ventricle of the heart;

inserting a snare device through an incision at a second location in the ventricular wall of the heart such that a distal end portion of the snare device is disposed with the left ventricle of the heart, a tether extending from a prosthetic mitral valve, extend through the left ventricle out through the incision at the second location in the ventricular wall of the heart;

snaring the distal end portion of the catheter with the snare device;

pulling the snare device with the snared distal end portion of the catheter through the incision at the second location in the ventricular wall while a proximal end of the catheter remains outside the incision at the first location;

threading a distal end of the tether through a distal opening defined by the catheter, through a lumen defined by the catheter and out a proximal opening defined by the catheter;

removing the catheter leaving the tether extending through the incision at the first location in the ventricular wall of the heart; and

adjusting a tension on the tether between the prosthetic mitral valve and the incision at the first location in the ventricular wall of the heart.

22. The method of claim 21, further comprising:

securing the tether at the first location on the ventricular wall of the heart with an epicardial pad device.

23. The method of claim 21, wherein the catheter is flexible such that the catheter can bend to extend between the incision at the first location in the ventricular wall of the heart and the incision at the second location in the ventricular wall of the heart.

24. The method of claim 21, wherein the catheter includes a bend formed in the catheter such that the catheter can extend between the incision at the first location in the ventricular wall of the heart and the incision at the second location in the ventricular wall of the heart.