Granted Patent B2

US 12,251,307 · App. 18/166,757 · Granted Mar 18, 2025

Inventors: Tal Reich (Moledet, IL); Eran Miller (Moshav Beit Elazari, IL)

Assignee: Edwards Lifesciences Innovation (Israel) Ltd.

A61F2/2427A61B17/0401A61B17/3209A61F2/2457A61F2/2466A61B2017/00243A61B2017/00247A61B2017/0409A61B2017/044A61B2017/0441A61B2017/0443A61B2017/0464A61B2017/22042A61B2017/22047A61B2017/3488A61M25/04A61M25/09A61M2025/09183

Abstract

Claims (63)

1. Apparatus, for use at tissue of a heart of a subject, the apparatus comprising:

an anchor, shaped to define a tissue-penetrating helix;

a guidewire coupled to the anchor;

an implant:

transluminally advanceable along the guidewire toward the anchor, and

intracardially couplable to the anchor to become secured to the tissue by the anchor; and

a deployment tool, reversibly coupled to the anchor, comprising a lance, and configured to:

transluminally advance the implant and the anchor to the heart,

stabilize the anchor at the tissue by driving the lance into the tissue,

anchor the anchor to the tissue by driving the tissue-penetrating helix into the tissue while the anchor remains stabilized at the tissue by the lance in the tissue, and

subsequently, retract the lance from the tissue while leaving the implant secured to the tissue by the anchor anchored to the tissue.

2. The apparatus according to claim 1 , wherein the tissue is tissue of a ventricle of the heart, and wherein the deployment tool is configured to transluminally advance the anchor to the ventricle.

3. The apparatus according to claim 1 , wherein the deployment tool is configured to retract the lance from the tissue by retracting the lance through the anchor.

4. The apparatus according to claim 1 , wherein the deployment tool is configured to transluminally advance the anchor to the heart with the lance extended beyond the tissue-penetrating helix.

5. The apparatus according to claim 1 , wherein the anchor is shaped to define a hole through which the lance is slidable.

6. The apparatus according to claim 1 , wherein the deployment tool is configured to intracardially extend the lance beyond the tissue-penetrating helix prior to driving the lance into the tissue.

7. The apparatus according to claim 6 , wherein the deployment tool is configured to intracardially extend the lance beyond the tissue-penetrating helix by intracardially sliding the lance through the anchor.

8. The apparatus according to claim 1 , further comprising a guide member that is percutaneously deliverable to the heart, wherein:

the guide member comprises:

a distal chord-engaging element that is configured to be reversibly slidably coupled to a chorda tendinea of the heart; and

a longitudinal element leading to the distal chord-engaging element, and

the deployment tool is configured to advance the anchor toward the tissue by sliding along the longitudinal element toward the chord-engaging element.

9. The apparatus according to claim 8 , further comprising a housing that is percutaneously deliverable to the heart, wherein:

the housing is shaped to define an opening, and

the chord-engaging element is intracardially extendable out of the opening.

10. The apparatus according to claim 9 , wherein the chord-engaging element is configured to be slidably coupled to the chorda tendinea by helically wrapping around the chorda tendinea.

11. The apparatus according to claim 10 , wherein:

the chord-engaging element is percutaneously deliverable to the heart while the chord-engaging element is constrained inside the housing, and

the chord-engaging element is configured to curl into a helical shape upon being extended out of the opening.

12. The apparatus according to claim 9 , further comprising a guidewire, configured to be transluminally advanced to a vicinity of the chorda tendinea.

13. The apparatus according to claim 12 , wherein the housing is shaped to define a channel therethrough, the housing being slidable along the guidewire by the guidewire being slidable through the channel.

14. The apparatus according to claim 9 , wherein the housing is configured to be decoupled from the guide member prior to the deployment tool sliding along the longitudinal element toward the chord-engaging element.

15. A method for use at a tissue of a heart of a subject, the method comprising:

to the heart, transluminally advancing an anchor coupled to a guidewire and to a deployment tool, the deployment tool including a lance;

advancing an implant along the guidewire toward the anchor;

stabilizing the anchor at the tissue by driving the lance into the tissue;

securing the implant to the tissue by intracardially coupling the implant to the anchor;

while the anchor remains stabilized at the tissue by the lance in the tissue, anchoring the anchor to the tissue by driving a tissue-penetrating helix of the anchor into the tissue, and

subsequently, retracting the lance from the tissue while leaving the implant secured to the tissue by the anchor anchored to the tissue.

16. The method according to claim 15 , wherein retracting the lance from the tissue comprises retracting the lance through the anchor.

17. The method according to claim 15 , wherein the tissue is tissue of a ventricle of the heart, and wherein transluminally advancing the anchor to the heart comprises transluminally advancing the anchor to the ventricle.

18. The method according to claim 15 , wherein driving the lance into the tissue comprises sliding the lance through the anchor.

19. The method according to claim 15 , wherein retracting the lance from the tissue comprises sliding the lance through the anchor.

20. A method for use at a tissue of a heart of a subject, the method comprising:

to the heart, transluminally advancing a guide member, including a longitudinal element leading to a distal chord-engaging element;

coupling the distal chord-engaging element to a chorda tendinea of the heart;

sliding the distal chord-engaging element along the chorda tendinea toward the tissue;

advancing an anchor toward the tissue by sliding a deployment tool, coupled to the anchor, along the longitudinal element toward the chord-engaging element;

stabilizing the anchor at the tissue by driving a lance of the deployment tool into the tissue;

anchoring the anchor to the tissue by driving a tissue-penetrating helix of the anchor into the tissue while the anchor remains stabilized at the tissue by the lance in the tissue; and

subsequently, while leaving the anchor anchored to the tissue, retracting the lance from the tissue and decoupling the distal chord-engaging element from the chorda tendinea.

21. The method according to claim 20 , wherein:

the guide member is housed in a housing that is percutaneously deliverable to the heart, and

sliding the distal chord-engaging element along the chorda tendinea toward the tissue comprises intracardially sliding the distal chord-engaging element through an opening in the housing, and extending the chord-engaging element out of the opening.

22. The method according to claim 21 , wherein sliding the distal chord-engaging element along the chorda tendinea toward the tissue slidably couples the chord-engaging element to the chorda tendinea by helically wrapping around the chorda tendinea.

23. The method according to claim 21 , comprising:

percutaneously delivering the chord-engaging element to the heart while the chord-engaging element is constrained inside the housing, and

wherein extending the chord-engaging element out of the opening comprises extending the chord-engaging element out of the opening in a manner that the chord-engaging element curls into a helical shape around the chorda tendinea.

24. The method according to claim 21 , further comprising a step of transluminally advancing a guidewire to a vicinity of the chorda tendinea.

25. The method according to claim 24 , wherein the housing is shaped to define a channel therethrough, and transluminally advancing the guidewire to a vicinity of the chorda tendinea comprises sliding the guidewire through the channel.

26. The method according to claim 21 , further comprising a step of decoupling the housing from the guide member prior to sliding the deployment tool along the longitudinal element toward the chord-engaging element.

27. The method according to claim 20 , further comprising a step of coupling a guidewire to the anchor.

28. The method according to claim 27 , further comprising transluminally advancing an implant along the guidewire toward the anchor, and intracardially coupling the implant to the anchor in a manner that the implant is configured to be secured to the tissue by the anchor.

Assignments (3)

Continuity (5)

References Cited (400)