IP Library Granted Patent US 12,350,158
Granted Patent B2
US 12,350,158 · App. 17/390,769 · Granted Jul 8, 2025

Annuloplasty ring delivery catheters

Inventors: Tal Sheps (Givat Shmuel, IL); Tal Hammer (Ramat Gan, IL); Tal Reich (Moledet, IL); Amir Gross (Tel Aviv-Jaffa, IL); Yuval Zipory (Modi'in, IL); Oz Cabiri (Hod Hasharon, IL); Yosef Gross (Moshav Mazor, IL)
Assignee: Edwards Lifesciences Innovation (Israel) Ltd.
A61F2/2466A61B17/068A61B90/50A61B2017/00243A61B2017/00327A61B2017/0649A61B2017/0688A61F2/2445A61F2220/0016A61F2230/0013A61F2250/0012
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Quick Facts
Patent No.
US 12,350,158
App. No.
17/390,769
Granted
Jul 8, 2025
Kind
B2
Abstract

Apparatus is provided for repairing a cardiac valve, the apparatus including a catheter sized for delivery through vasculature of a subject and an elongated and flexible annuloplasty structure having an annuloplasty structure axis. The annuloplasty structure is sized and configured for delivery to a heart of the subject through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis. The apparatus also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within a delivery passage of the catheter. Other embodiments are also described.

Claims (69)

1. A system for repairing a cardiac valve, the system comprising:

a catheter sized for delivery through vasculature of a subject, the catheter defining a delivery passage and having a catheter axis extending therethrough;

an elongated and flexible annuloplasty structure defining an annuloplasty structure axis, and being sized and configured for delivery to a heart of the subject through the delivery passage substantially along the catheter axis while the annuloplasty structure axis is substantially parallel to the catheter axis; and

multiple anchors, each configured for independent:

introduction into a proximal end of the catheter, and

advancement, from the proximal end of the catheter, distally through the catheter toward the annuloplasty structure and the heart substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within the delivery passage of the catheter.

2. The system according to claim 1 , further comprising an elongated and flexible deployment manipulator that comprises an anchor driver sized and configured to, while at least the portion of the annuloplasty structure is within the delivery passage of the catheter, for each of the multiple anchors, independently:

introduce the anchor into the proximal end of the catheter,

advance the anchor from the proximal end of the catheter, distally through the catheter toward the annuloplasty structure and the heart substantially along the annuloplasty structure axis and the catheter axis,

advance the anchor along at least the portion of the annuloplasty structure by the anchor driver extending along the annuloplasty structure, and

anchor the annuloplasty structure to tissue of the heart by driving the anchor into the tissue.

3. The system according to claim 2 , wherein the deployment manipulator is steerable.

4. The system according to claim 2 , further comprising a first control mechanism and a second control mechanism, wherein the first and the second control mechanisms are configured to enable independent movement of the catheter and the deployment manipulator, respectively.

5. The system according to claim 4 , wherein the first control mechanism and the second control mechanism are configured to enable incremental release of the annuloplasty structure from the catheter as the multiple anchors are independently driven into the tissue.

6. The system according to claim 1 , wherein:

the catheter is an inner catheter, and

the system further comprises an outer catheter sized for delivery through the vasculature, the outer catheter defining an outer catheter lumen and having an outer catheter axis extending therethrough, wherein the outer catheter lumen is sized and configured to hold at least a portion of the inner catheter therein while the inner catheter is substantially parallel to the outer catheter axis.

7. The system according to claim 6 , wherein:

the inner catheter is steerable in a plane, and

the system is configured to assume a multi-bend formation in which:

a first bend of the formation separates a first domain of the formation from a second domain of the formation,

a second bend of the formation separates the second domain of the formation from a third domain of the formation,

the first domain comprises at least (i) part of the outer catheter and (ii) a first part of the inner catheter,

the second domain (i) comprises a second part of the inner catheter, a first part of the annuloplasty structure, and none of the outer catheter, and (ii) is disposed in the plane, and

the third domain (i) comprises a second part of the annuloplasty structure, none of the outer catheter, and none of the inner catheter, and (ii) extends out of the plane.

8. The system according to claim 6 , further comprising an inner catheter control mechanism and an outer catheter control mechanism configured to enable independent movement of the inner catheter and the outer catheter.

9. The system according to claim 6 , further comprising a first locking mechanism located at a distal region of the inner catheter and a second locking mechanism located at a proximal region of the inner catheter, wherein the first and the second locking mechanisms are configured to inhibit rotation of the inner catheter with respect to the outer catheter.

10. The system according to claim 9 , wherein the first locking mechanism comprises a detent.

11. The system according to claim 10 , wherein the first and the second locking mechanisms are configured to lock substantially simultaneously.

12. The system according to claim 1 , wherein the annuloplasty structure has an elongate lumen, and wherein each of the multiple anchors is deliverable along the elongate lumen, and is configured to, from within the elongate lumen, penetrate and pass through material of the annuloplasty structure.

13. A method for repairing a valve of a heart of a subject, the valve being disposed between an atrium and a ventricle of the heart, and the method comprising:

transluminally advancing a catheter to the atrium, the catheter defining a delivery passage and having a catheter axis extending therethrough;

delivering an elongated and flexible annuloplasty structure defining an annuloplasty structure axis to the atrium through the delivery passage substantially along the catheter axis while the annuloplasty structure axis is substantially parallel to the catheter axis; and

anchoring the annuloplasty structure to an annulus of the valve by sequentially, for each of multiple anchors independently:

introducing the anchor into a proximal end of the catheter,

advancing the anchor from the proximal end of the catheter, distally through the catheter toward the annuloplasty structure and the heart along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within the delivery passage of the catheter, and

from within the atrium, driving the anchor into the annulus.

14. The method according to claim 13 , further comprising, for each of the multiple anchors independently sequentially, engaging the anchor with an anchor driver, wherein advancing the anchor comprises advancing the anchor by advancing the anchor driver, engaged with the anchor, distally through the catheter toward the annuloplasty structure and the heart substantially along the catheter axis while at least the portion of the annuloplasty structure is within the delivery passage of the catheter.

15. The method according to claim 13 , wherein the annuloplasty structure has an elongate lumen, and wherein anchoring the annuloplasty structure to the annulus comprises, from within the elongate lumen, penetrating and passing each of the multiple anchors though material of the annuloplasty structure.

16. The method according to claim 13 , wherein:

the catheter is an inner catheter, and is steerable in a plane;

delivering the annuloplasty structure to the atrium comprises delivering the annuloplasty structure to the atrium substantially along the catheter axis while (i) the annuloplasty structure is substantially parallel to the catheter axis, and (ii) the inner catheter extends distally through and out of an outer catheter;

for at least one of the multiple anchors, driving the anchor into the annulus comprises driving the anchor into the annulus while the outer catheter, the inner catheter, and the annuloplasty structure are collectively in a multi-bend formation in which:

a first bend of the formation separates a first domain of the formation from a second domain of the formation,

a second bend of the formation separates the second domain of the formation from a third domain of the formation,

the first domain comprises at least (i) part of the outer catheter and (ii) a first part of the inner catheter,

the second domain (i) comprises a second part of the inner catheter, a first part of the annuloplasty structure, and none of the outer catheter, and (ii) is disposed in the plane, and

the third domain (i) comprises a second part of the annuloplasty structure, none of the outer catheter, and none of the inner catheter, and (ii) extends out of the plane.

17. The method according to claim 13 , wherein:

the catheter has a distal opening at a distal end of the catheter;

the method further comprises exposing a first portion of the annuloplasty structure out of the distal opening at the valve;

the step of anchoring comprises sequentially, for each of the multiple anchors independently, using the anchor to anchor the annuloplasty structure to the annulus while (i) the first portion of the annuloplasty structure remains exposed out of the distal opening at the valve, and (ii) a second portion of the annuloplasty structure remains within the delivery passage of the catheter.

18. The method according to claim 13 , wherein:

the catheter has a distal opening at a distal end of the catheter;

the multiple anchors comprise a first anchor and multiple other anchors; and

the step of anchoring comprises:

introducing the first anchor into the proximal end of the catheter,

advancing the first anchor from the proximal end of the catheter, distally through the catheter toward the annuloplasty structure and the heart along the annuloplasty structure axis and the catheter axis,

from within the atrium, anchoring a first portion of the annuloplasty structure to the annulus by driving the first anchor into the annulus while at a second portion of the annuloplasty structure is within the delivery passage of the catheter, and

while (i) the first portion of the annuloplasty structure remains anchored at the valve, and (ii) the second portion of the annuloplasty structure remains within the delivery passage of the catheter, sequentially advancing the multiple other anchors from the proximal end of the catheter toward the annuloplasty structure and the heart substantially along the annuloplasty structure axis and the catheter axis.

19. A system for repairing a valve of a heart of a subject, the system comprising:

a catheter sized for delivery through vasculature of the subject, the catheter defining a delivery passage and having (i) a catheter axis extending therethrough, and (ii) a distal opening at a distal end of the catheter;

an elongated and flexible annuloplasty structure defining an annuloplasty structure axis, and being sized and configured for delivery to the heart through the delivery passage substantially along the catheter axis while the annuloplasty structure axis is substantially parallel to the catheter axis; and

multiple anchors, each anchor configured for independent delivery into a proximal end of the catheter and through the catheter, toward the annuloplasty structure and the heart substantially along the annuloplasty structure axis and the catheter axis while (i) a first portion of the annuloplasty structure is exposed out of the distal opening at the valve, and (ii) a second portion of the annuloplasty structure remains within the delivery passage of the catheter.

20. A system for repairing a valve of a heart of a subject, the system comprising:

a catheter sized for delivery through vasculature of the subject, the catheter defining a delivery passage and having (i) a catheter axis extending therethrough, and (ii) a distal opening at a distal end of the catheter;

an elongated and flexible annuloplasty structure defining an annuloplasty structure axis, and being sized and configured for delivery to the heart through the delivery passage substantially along the catheter axis while the annuloplasty structure axis is substantially parallel to the catheter axis;

a first anchor, configured for delivery distally through the catheter, to anchor a first portion of the annuloplasty structure at the valve, and

multiple other anchors, each of the other anchors configured for independent delivery into a proximal end of the catheter and through the catheter, toward the annuloplasty structure and the heart substantially along the annuloplasty structure axis and the catheter axis while (i) the first portion of the annuloplasty structure remains anchored at the valve, and (ii) a second portion of the annuloplasty structure remains within the delivery passage of the catheter.

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 May 12, 2022
From: SHEPS, TAL; HAMMER, TAL; REICH, TAL; GROSS, AMIR; ZIPORY, YUVAL; CABIRI, OZ; GROSS, YOSSI
To: VALTECH CARDIO LTD.
Reel/Frame 059985/0740 →
Continuity (15)
Continuation 15977271 · May 11, 2018
Continuation 14273155 · May 8, 2014
Continuation In Part 13319030
Continuation In Part 12435291 · May 4, 2009
Continuation In Part 12437103 · May 7, 2009
Continuation In Part 12548991 · Aug 27, 2009
Continuation In Part 12689635 · Jan 19, 2010
Continuation In Part 12689693 · Jan 19, 2010
Continuation In Part 14242151 · Apr 1, 2014
Continuation 12437103 · May 7, 2009
Continuation In Part PCTIL2012050451 · Nov 8, 2012
Continuation In Part 14357040
Provisional Application 61557082 · Nov 8, 2011
Provisional Application 61820979 · May 8, 2013
Related Publication 20210353420A1 · Nov 18, 2021
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