Granted Patent B2

US 12,414,772 · App. 17/827,646 · Granted Sep 16, 2025

Inventors: Yaron Herman (Givat Ada, IL); Yuval Zipory (Modi'in, IL); Slava Starobinsky (Netanya, IL); Tal Reich (Moledet, IL); Ehud Aviv (Costa Mesa, CA); Alexei Koifman (Melbourne, AU)

Assignee: Edwards Lifesciences Innovation (Israel) Ltd.

A61B17/12009A61B17/0401A61B2017/00477A61B2017/00681A61B2017/0409A61B2017/0411A61B2017/0441A61B2017/0464A61B2017/0496A61B2017/2937A61F2/2445

Abstract

Claims (58)

1. A system for use with a tissue of a subject, the system comprising:

a tissue anchor, comprising:

an engaging head, comprising a coupling eyelet that defines an eyelet plane, and

a tissue-coupling element that defines a helix that is reversibly screwable into the tissue, and that has a central helix axis that lies on the eyelet plane; and

an anchor driver, having a distal portion that is transluminally advanceable toward the tissue, and comprising:

a casing that defines a slot, the slot:

defining a slot plane, and

having a fixed dimension for receiving at least part of the eyelet therein in a manner in which the eyelet plane is coplanar with the slot plane;

a detent, actuatable to move with respect to the casing to become disposed through the eyelet in the slot in a manner that reversibly inhibits exiting of the eyelet from the slot; and

the anchor driver being configured to screw the tissue anchor into the tissue by rotating the tissue anchor about the central helix axis by applying a rotational force to the eyelet.

2. The system according to claim 1 , wherein the slot is dimensioned to receive the at least part of the eyelet snugly.

3. The system according to claim 1 , wherein the anchor driver further comprises a controller, configured to move the detent between (i) a closed state in which the at least part of the eyelet is inhibited from exiting the slot, and (ii) an open state in which the at least part of the eyelet is slidable out of the slot.

4. A system according to claim 3 , wherein:

the casing defines a recess,

at least part of the detent moves into the recess when the detent moves into the open state thereof, and

the controller comprises a rod, configured to move the detent into the closed state thereof by the rod being slid into at least part of the recess.

5. The system according to claim 1 , further comprising an anchor-retrieval tool, transluminally advanceable independently of the anchor driver, wherein the anchor-retrieval tool comprises:

an anchor-engaging element comprising one or more arms, configured to be coupled to the engaging head,

a housing that defines a compartment therein, and

a retrieval-tool controller, comprising an adjuster configured to move at least part of the anchor-engaging element into and out of the compartment.

6. The system according to claim 1 , further comprising an anchor-retrieval tool, transluminally advanceable independently of the anchor driver, wherein the anchor-retrieval tool:

comprises, at a distal portion thereof, an anchor-engaging element comprising a curved arm, configured to be coupled to the tissue anchor by moving through the eyelet, and

is configured, while the anchor-engaging element is coupled to the tissue anchor, to apply a rotational de-anchoring force to the tissue anchor.

7. The system according to claim 6 , wherein the curved arm is generally helical, and is configured to be coupled to the eyelet by being rotated with respect to the eyelet.

8. The system according to claim 7 , wherein the tissue-coupling element has a handedness, and the curved arm has a handedness that is opposite to the handedness of the tissue-coupling element.

9. The system according to claim 6 , wherein the anchor-engaging element is configured to be coupled to the tissue anchor by being rotated with respect to the tissue anchor, and the anchor-retrieval tool is configured to apply the rotational de-anchoring force to the tissue anchor by at least part of the anchor-engaging element being rotated with respect to the tissue anchor.

10. The system according to claim 1 , wherein the detent is configured to transition between (i) a closed state in which the at least part of the eyelet is inhibited from exiting the slot, and (ii) an open state in which the at least part of the eyelet is slidable out of the slot.

11. The system according to claim 1 , wherein:

the casing further defines a recess in communication with the slot, and

the detent is actuatable to move with respect to the casing to become disposed through the eyelet in the slot by being actuatable to move out of the recess and into the slot to become disposed through the eyelet in the slot.

12. A system for use with a tissue of a subject, the system comprising:

(i) a tissue anchor, comprising:

an engaging head, comprising a coupling eyelet that defines an eyelet plane, and

a helical tissue-coupling element, reversibly anchorable to the tissue, and having a central helix axis that lies on the eyelet plane;

(ii) an anchor driver, configured to anchor the tissue anchor to the tissue by rotating the tissue anchor about the central helix axis by applying a rotational force to the eyelet, the anchor driver comprising:

a casing that defines a slot, the slot defining a slot plane, and dimensioned to receive at least part of the eyelet therein in a manner in which the eyelet plane is coplanar with the slot plane, and

a detent, configured to reversibly inhibit movement of the eyelet with respect to the slot; and

(iii) an anchor-retrieval tool, transluminally advanceable independently of the anchor driver, the anchor-retrieval tool comprising:

at a distal portion, an anchor-engaging-element actuator, and an anchor-engaging element comprising a curved arm, and configured to be coupled to the tissue anchor by moving through the eyelet, and

at a proximal portion of the anchor-retrieval tool, a retrieval-tool controller configured to control the anchor-engaging-element actuator,

wherein:

the system has at least two states:

(1) an uncoupled state in which the anchor-engaging element is not in contact with the tissue anchor, and

(2) an articulatably-coupled state in which:

the engaging head at least in part inhibits movement of the anchor-engaging element away from the tissue anchor, and

the distal portion is deflectable with respect to the tissue anchor;

the anchor-engaging-element actuator is configured to facilitate transition of the system from the uncoupled state to the articulatably-coupled state; and

in at least one of the at least two states, the anchor-retrieval tool is configured, while coupled to the tissue anchor, to apply a rotational de-anchoring force to the tissue anchor.

13. The system according to claim 12 , wherein in the articulatably-coupled state, the distal portion of the anchor-retrieval tool is rotatable with respect to the tissue anchor.

14. The system according to claim 13 , wherein the anchor-retrieval tool is configured to rotate the tissue anchor by applying the de-anchoring force to the tissue anchor.

15. The system according to claim 12 , wherein the at least two states further comprise a rigidly-coupled state in which the distal portion of the anchor-retrieval tool is inhibited from articulating with respect to the tissue anchor.

16. The system according to claim 15 , wherein the anchor-retrieval tool is configured to apply the de-anchoring force to the tissue anchor while the system is in the rigidly-coupled state.

17. The system according to claim 15 , wherein the anchor-engaging-element actuator is configured to transition the system from the articulatably-coupled state to the rigidly-coupled state by sliding, with respect to the anchor-engaging element, along a longitudinal axis of the distal portion of the tool.

18. The system according to claim 12 , wherein the anchor-engaging element comprises at least a first arm and a second arm, a curve of each of the arms defining a respective concavity, and the arms positioned such that the concavity of the first arm faces the concavity of the second arm.

19. The system according to claim 18 , wherein the anchor-engaging element further comprises a housing that defines a compartment therein, and an adjuster that is configured to move at least part of each of the arms into and out of the compartment.

20. The system according to claim 19 , wherein,

when the anchor-engaging element is coupled to the tissue anchor, the anchor-retrieval tool is configured to move at least part of the eyelet into the compartment by the at least part of each of the arms moving into the compartment, and

the housing is configured to apply the rotational de-anchoring force to the tissue anchor by the housing being rotated while the at least part of the eyelet is disposed within the compartment.

Assignments (3)

Continuity (7)

References Cited (400)