IP Library Granted Patent US 11,602,434
Granted Patent B2
US 11,602,434 · App. 16/701,054 · Granted Mar 14, 2023

Systems and methods for tissue adjustment

Inventors: Eran Miller (Moshav Beit Elazari, IL); Uriel Aba Pomerantz (Kfar Sava, IL); Oz Cabiri (Hod Hasharon, IL); Yaron Herman (Givat Ada, IL); Yoseph Weitzman (Tel Aviv-Jaffa, IL); Yosef Gross (Moshav Mazor, IL)
Assignee: Edwards Lifesciences Innovation (Israel) Ltd.
A61F2/2466A61B17/0401A61B17/0469A61F2/2427A61F2/2457A61B2017/00243A61B2017/044A61B2017/048A61B2017/0409A61B2017/0414A61B2017/0441A61B2017/0464
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Quick Facts
Patent No.
US 11,602,434
App. No.
16/701,054
Granted
Mar 14, 2023
Kind
B2
Abstract

Apparatus is provided, including an implant including a tissue-adjusting member including a longitudinal member, and a tissue anchor coupled to the tissue-adjusting member and configured to be anchored into the tissue of the patient. A tissue-coupling element is coupled to the longitudinal member. A delivery tool is reversibly couplable to the implant and is configured to deliver the implant to the tissue of the patient. The delivery tool includes an elongate shaft, a tissue-coupling-element holder coupled to a portion of the elongate shaft, the tissue-coupling-element holder being configured to hold the tissue-coupling element during delivery of the implant to the tissue of the patient, and an actuating element configured to rotate the tissue anchor so as to facilitate anchoring of the tissue anchor into the tissue of the patient while not rotating the tissue-coupling-element holder with respect to the shaft.

Claims (36)

1. Apparatus, comprising:

an implant comprising:

a tissue-adjusting member configured to be coupled to cardiovascular tissue of a patient, the tissue-adjusting member comprising a longitudinal member; and

a tissue anchor coupled to the tissue-adjusting member, wherein the tissue anchor comprises a helical shape configured to be screwed into the cardiovascular tissue of the patient;

a tissue-coupling element coupled to the longitudinal member; and

a delivery tool reversibly couplable to the implant, the delivery tool being configured to cardiovascular deliver the implant to the cardiovascular tissue of the patient, the delivery tool comprising:

a handle;

an elongate shaft, extending distally away from the handle;

a tissue-coupling-element holder coupled to a portion of the elongate shaft distal from the handle, the delivery tool being configured to deliver the implant endovascularly to the cardiovascular tissue while the handle is outside the patient and the tissue-coupling-element holder, disposed proximally from the tissue anchor, holds the tissue coupling element; and

an actuating element configured to screw the tissue anchor into the cardiovascular tissue by rotating the tissue anchor about an axis of rotation that is along a longitudinal axis of the delivery tool while not rotating the tissue-coupling-element holder with respect to the shaft.

2. The apparatus according to claim 1 , wherein the tissue-adjusting member comprises one or more artificial chordae tendineae.

3. The apparatus according to claim 1 , wherein the tissue-coupling-element holder surrounds the portion of the elongate shaft.

4. The apparatus according to claim 1 , wherein the tissue-coupling-element holder is coupled to the portion of the elongate shaft in a manner in which pulling the tissue-coupling-element holder proximally facilitates pulling of the elongate shaft proximally.

5. The apparatus according to claim 1 , wherein the tissue-coupling-element holder is shaped so as to define a planar element.

6. The apparatus according to claim 1 , where the tissue-coupling element comprises a needle, and wherein the tissue-coupling-element holder is shaped so as to define a slit for reversibly coupling the tissue-coupling element to the tissue-coupling-element holder.

7. The apparatus according to claim 1 , wherein the elongate shaft comprises a multi-lumen elongate shaft, and wherein, during the delivery of the implant to the cardiovascular tissue of the patient, the longitudinal member is disposed within a secondary lumen of the multi-lumen elongate shaft.

8. The apparatus according to claim 7 , wherein the secondary lumen is shaped so as to define a slit that runs parallel to a longitudinal axis of the delivery tool, and wherein the longitudinal member is pullable away from the longitudinal axis of the delivery tool via the slit in order to remove the longitudinal member from within the elongate shaft.

9. The apparatus according to claim 1 , wherein during the anchoring of the cardiovascular tissue anchor into the tissue of the patient, the tissue-coupling-element holder is configured to be accessible from outside of a body of the patient.

10. A method, comprising:

using a delivery tool, advancing an implant endovascularly to cardiovascular tissue and delivering the implant to cardiovascular tissue, the implant including (1) a tissue-adjusting member including a longitudinal member, and (2) a tissue anchor coupled to the tissue-adjusting member, the tissue anchor comprising a helical shape configured to be screwed into the cardiovascular tissue, the tissue-adjusting member being coupled to a tissue-coupling element, the delivery tool including:

a handle;

an elongate shaft, extending distally away from the handle;

a tissue-coupling-element holder coupled to a distal portion of the elongate shaft, the tissue-coupling-element holder being configured to hold the tissue-coupling element during the delivering of the implant to the cardiovascular tissue; and

an actuating element configured to rotate the tissue anchor about an axis of rotation that is along a longitudinal axis of the delivery tool

screwing the tissue anchor into the cardiovascular tissue by rotating the tissue anchor about the axis of rotation by rotating the actuating element of the delivery tool while not rotating the tissue-coupling-element holder with respect to the shaft.

11. The method according to claim 10 , wherein the tissue-adjusting member includes one or more artificial chordae tendineae.

12. The method according to claim 10 , wherein the tissue-coupling-element holder surrounds the portion of the elongate shaft.

13. The method according to claim 10 , further comprising pulling of the elongate shaft proximally by pulling the tissue-coupling-element holder proximally.

14. The method according to claim 10 , wherein during the anchoring of the tissue anchor into the cardiovascular tissue, the tissue-coupling-element holder is configured to be accessible from outside of a body of a patient, and wherein the method comprises accessing the tissue-coupling-element holder from outside the body of the patient.

15. The method according to claim 10 , further comprising:

subsequently to the anchoring of the tissue anchor into the cardiovascular tissue, suturing the longitudinal member to the cardiovascular tissue using the tissue-coupling element; and

subsequently to the suturing, clipping the longitudinal member and removing from a body of a patient (a) excess portions of the longitudinal member, and (b) the tissue-coupling element.

16. The method according to claim 10 , where the tissue-coupling element includes a needle, wherein the tissue-coupling-element holder is shaped so as to define a slit for reversibly coupling the tissue-coupling element to the tissue-coupling-element holder, and wherein the method further comprises decoupling the needle from the slit of the tissue-coupling-element holder subsequently to the delivering of the implant.

17. The method according to claim 16 , further comprising, subsequently to the decoupling of the needle from the slit, suturing the longitudinal member to the cardiovascular tissue using the needle.

18. The method according to claim 10 , wherein the elongate shaft comprises a multi-lumen elongate shaft, and wherein, during the delivering of the implant to the cardiovascular tissue, the longitudinal member is disposed within a secondary lumen of the multi-lumen elongate shaft.

19. The method according to claim 18 , wherein the secondary lumen is shaped so as to define a slit that runs parallel to a longitudinal axis of the delivery tool, and wherein the method further comprises removing the longitudinal member from within the elongate shaft by pulling the longitudinal member away from the longitudinal axis of the delivery tool via the slit.

Assignments (2)
CHANGE OF NAME Recorded Sep 30, 2022
From: VALTECH CARDIO LTD.
To: EDWARDS LIFESCIENCES INNOVATION (ISRAEL) LTD.
Reel/Frame 061587/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2020
From: WEITZMAN, YOSEPH; MILLER, ERAN; POMERANTZ, URIEL ABA; CABIRI, OZ; HERMAN, YARON; GROSS, YOSSI
To: VALTECH CARDIO, LTD.
Reel/Frame 051984/0414 →
Continuity (5)
Continuation 15463656 · Mar 20, 2017
Continuation 14246417 · Apr 7, 2014
Continuation 12926673 · Dec 2, 2010
Provisional Application 61265936 · Dec 2, 2009
Related Publication 20200100899A1 · Apr 2, 2020