IP Library › Granted Patent US 12,364,606
Granted Patent B2
US 12,364,606 · App. 17/549,194 · Granted Jul 22, 2025

Fluoroscopic visualization of heart valve anatomy

Inventors: Eran Hoffer (Yahud, IL); Sarit Avivi (Givat Shmuel, IL); Yaron Herman (Givat Ada, IL); Tal Sheps (Givat Shmuel, IL); Ehud Aviv (Costa Mesa, CA); Boaz Manash (Givat Ada, IL); Meir Kutzik (Kafir Saba, IL); Or Cohen (Modi'in, IL)
Assignee: Edwards Lifesciences Innovation (Israel) Ltd.
A61F2/2496A61B90/39A61F2/2445A61F2/2466A61B2017/0649A61B2090/3966A61F2250/0098
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Quick Facts
Patent No.
US 12,364,606
App. No.
17/549,194
Granted
Jul 22, 2025
Kind
B2
Abstract

A radiopaque frame is transluminally advanced to an atrium of a heart of a subject. The frame is expanded within a valve adjacent the atrium such that part of the frame remains disposed in the atrium. While the frame remains expanded within the valve, progressive portions of an annuloplasty structure are progressively positioned and anchored around the annulus using multiple anchors by, for each of the anchors sequentially (i) while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and (ii) driving the anchor into the annulus laterally from the frame. Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus. Other embodiments are also described.

Claims (29)

1. A method for use at a valve disposed between an atrium and a ventricle of a heart of a subject, the valve having an annulus, and the method comprising:

transluminally advancing a radiopaque frame to the atrium;

expanding the frame within the valve such that part of the frame remains disposed in the atrium;

while the frame remains expanded within the valve with the part of the frame disposed in the atrium, progressively positioning and anchoring progressive portions of an annuloplasty structure around the annulus using multiple anchors by, for each of the multiple anchors sequentially:

while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and

while the distal end of the delivery tool remains disposed between the frame and the wall of the atrium, driving the anchor into the annulus laterally from the frame; and

subsequently, contracting the frame and withdrawing the frame from the subject while leaving the annuloplasty structure anchored around the annulus.

2. The method according to claim 1 , wherein expanding the frame comprises expanding the frame such that a rail of the frame extends along the annulus.

3. The method according to claim 2 , wherein positioning the distal end of the delivery tool between the frame and the wall of the atrium facilitated by mechanical guidance from the frame comprises positioning the distal end of the delivery tool between the frame and the wall of the atrium facilitated by mechanical guidance from the rail.

4. The method according to claim 1 , wherein:

the frame includes a mesh, and

expanding the frame comprises expanding the frame such that the mesh defines a bulging ledge portion disposed against the valve, and a sloped upstream portion, tapering away from the bulging ledge portion into the atrium.

5. The method according to claim 4 , wherein positioning the distal end of the delivery tool between the frame and the wall of the atrium facilitated by mechanical guidance from the frame comprises sliding the distal end of the delivery tool along the sloped upstream portion.

6. The method according to claim 4 , wherein expanding the frame comprises expanding the frame such that the mesh further defines a trumpet portion within the ventricle.

7. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a bulbous shape.

8. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally umbrella shape.

9. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally spherical shape.

10. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally partially spherical shape.

11. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally ovoid shape.

12. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally teardrop shape.

13. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a generally conical shape.

14. The method according to claim 1 , wherein expanding the frame comprises expanding the frame into a pear shape.

15. The method according to claim 1 , wherein the frame includes a braided mesh, and wherein expanding the frame comprises expanding the braided mesh.

16. The method according to claim 1 , wherein the frame defines a conical stent, and wherein expanding the frame comprises expanding the conical stent.

17. The method according to claim 1 , wherein expanding the frame comprises expanding the frame by inflating a balloon disposed within the frame.

18. The method according to claim 1 , wherein positioning the distal end of the delivery tool comprises positioning the distal end of the delivery tool facilitated by fluoroscopic identification of bending of the frame caused by pressing of the frame against tissue of the heart.

19. The method according to claim 1 , wherein the frame has leaflets connected thereto, and wherein progressively positioning and anchoring progressive portions of the annuloplasty structure around the annulus while the frame remains expanded within the valve with the part of the frame disposed in the atrium comprises progressively positioning and anchoring progressive portions of the annuloplasty structure around the annulus while the frame remains expanded within the valve with the part of the frame disposed in the atrium and the leaflets regulate blood flow through the valve.

20. The method according to claim 1 , wherein the valve is a mitral valve of the heart, and wherein expanding the frame comprises expanding the frame such that an asymmetrical portion of the frame, in which the frame is shorter, is oriented toward an aortic valve of the heart.

21. The method according to claim 1 , wherein positioning the distal end of the delivery tool between the frame and the wall of the atrium facilitated by mechanical guidance from the frame comprises positioning the distal end of the delivery tool between the frame and the wall of the atrium facilitated by tactile feedback from contact between the delivery tool and the frame.

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 29, 2022
From: SHEPS, TAL; AVIV, EHUD; HERMAN, YARON; SHARON, ASSAF; MANASH, BOAZ; CHAPPEL-RAM, SHLOMIT; HOFFER, ERAN; COHEN, OR; GORDON, VADIM; HABERMAN BROWNS, BEZALEL; REICH, TAL; BENSHAHAR, TAL; PEER, AMIT; TENNENBAUM, GAD; HAROOSH, LIOR; KUTZIK, MEIR; KASHER, YUVAL; HADAD CHERNIN, OR; DE LA CRUZ ROMITO, EVA ADRIANA; AVIVI, SARIT
To: VALTECH CARDIO LTD.
Reel/Frame 059543/0162 →
Continuity (4)
Continuation PCTIL2020050807 · Jul 22, 2020
Provisional Application 62988322 · Mar 11, 2020
Provisional Application 62877785 · Jul 23, 2019
Related Publication 20220233316A1 · Jul 28, 2022
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