IP Library Granted Patent US 10,226,341
Granted Patent B2
US 10,226,341 · App. 15/197,069 · Granted Mar 12, 2019

Implant for heart valve

Inventors: Yossi Gross (Moshav Mazor, IL); Gil Hacohen (Ramat Gan, IL); Eran Miller (Moshav Beit Elazari, IL); Yuval Zipory (Modi'in, IL); Tal Reich (Moshav Moledet, IL); Meir Kutzik (Holon, IL); Rotem Neeman (Yeshuv Nirit, IL)
Assignee: CARDIOVALVE LTD.
A61F2/2442A61F2/2409A61F2/2418A61F2/2436A61F2/2439A61F2/2454A61F2/2466A61F2/2445A61F2/848A61F2220/0016A61F2220/0025A61F2220/0091A61F2230/0006A61F2230/0013A61F2250/006A61F2250/0015A61F2250/0069A61F2250/0071
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Quick Facts
Patent No.
US 10,226,341
App. No.
15/197,069
Filed
Jun 29, 2016
Granted
Mar 12, 2019
Kind
B2
Art Unit
3774
USPC
623/2.11
Abstract

For some applications, apparatus is provided for facilitating implantation of a prosthetic valve at a native heart valve of a subject, the apparatus comprising a prosthetic valve support, the prosthetic valve support (a) being configured to be transluminally-deliverable to the native valve and to be deployable at the native valve, and (b) comprising one or more tissue-engaging elements, configured to couple the prosthetic valve support to leaflets of the native valve without eliminating check valve functionality of the native valve. Other embodiments are also described.

Claims (52)

1. Apparatus for use at a native valve of a subject, the native valve including at least a first native leaflet and a second native leaflet, the apparatus comprising:

an implant, comprising:

an annular portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening, and

at least one leaflet clip:

(i) coupled to the annular portion,

(ii) comprising:

at least two clip arms, movable with respect to each other to open and close the clip; and

a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and

(iii) configured:

to be coupled to a portion of the first native leaflet by the clip arms being brought together to close around the first native leaflet,

to be coupled to a portion of the second native leaflet by the clip arms being brought together to close around the second native leaflet, and

to hold together the portion of the first leaflet and the portion of the second leaflet; and

a delivery apparatus, configured to deliver the implant to the native valve, and comprising at least one clip controller, the at least one clip controller being reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip, and the delivery apparatus being intracorporeally decouplable from the implant.

2. The apparatus according to claim 1 , wherein the clip controller is configured to facilitate opening and closing of the clip irrespective of a state of deployment of the implant.

3. The apparatus according to claim 1 , wherein the at least one clip comprises at least a first clip and a second clip, and wherein the second clip is openable and closeable independently of the first clip.

4. The apparatus according to claim 1 , wherein the at least one clip comprises at least a first clip and a second clip, and wherein the first clip is fixedly coupled to the second clip, and is configured to be intracorporeally decoupled from the second clip.

5. The apparatus according to claim 1 , wherein the at least one clip is configured to be lockable such that the first clip arm is locked with respect to the second clip arm.

6. The apparatus according to claim 1 , wherein the clip is flexibly coupled to the annular portion.

7. The apparatus according to claim 6 , wherein the clip is coupled to the annular portion via a flexible connector, the flexible connector having a length from the annular portion to the clip, and wherein the length of the flexible connector is variable.

8. The apparatus according to claim 1 , wherein the inner perimeter defines the opening, such that the opening has a depth and a width, and wherein the width of the opening is more than four times greater than the depth of the opening.

9. Apparatus for use at a native heart valve of a subject, the native heart valve including a native annulus and a plurality of native leaflets that provide check valve functionality, the apparatus comprising an implant configured to be transluminally-delivered to the native valve and to be deployed at the native valve, the implant comprising:

one or more tissue-engaging elements, configured to be coupled to the native leaflets, and to couple the implant to the native leaflets without eliminating the check valve functionality, by holding together a portion of one of the native leaflets and a portion of another of the native leaflets such that the one leaflet and the other leaflet become arranged to define two orifices between the one leaflet and the other leaflet, each orifice configured to function as a respective check-valve; and

an annular portion, configured to be secured against an upstream side of the native valve by the coupling of the one or more tissue-engaging elements to the native leaflets.

10. The apparatus according to claim 9 , wherein the tissue-engaging elements comprise at least a first tissue-engaging element and a second tissue-engaging element, and wherein the first tissue-engaging element is transluminally controllable independently of the second tissue-engaging element.

11. The apparatus according to claim 9 , wherein the implant comprises one or more flexible connectors, and wherein each tissue-engaging element is flexibly coupled to the annular portion by a respective flexible connector.

12. The apparatus according to claim 11 , wherein each flexible connector has a length, and is configured such that the length is variable while the tissue-engaging elements are coupled to the native leaflets.

13. The apparatus according to claim 9 , wherein the tissue-engaging elements comprise clips, each clip comprising a plurality of clip arms, comprising at least a first clip arm and a second clip arm, and configured to couple at least a portion of one of the native leaflets between the first and second clip arms.

14. The apparatus according to claim 13 , further comprising a clip controller, configured to be advanced transluminally to the native valve, wherein each clip comprises a clip-controller interface, configured to be reversibly coupled to the clip controller, and to facilitate extracorporeal control of the clips independently of deployment of the implant.

15. The apparatus according to claim 14 , wherein each clip is configured such that movement of at least a portion of the clip-controller interface by a first distance, changes a distance between a portion of the first clip arm and a portion of the second clip arm by a second distance that is more than 1.5 times greater than the first distance.

16. A method, comprising:

using a delivery apparatus, transluminally advancing an implant to a native heart valve of a subject, the native valve including at least a first native leaflet and a second native leaflet, the implant including:

an annular portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening, and

at least one leaflet clip:

(i) coupled to the annular portion,

(ii) comprising:

at least two clip arms, movable with respect to each other to open and close the clip; and

a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and

(iii) configured:

to be coupled to a portion of the first native leaflet by the clip arms being brought together to close around the first native leaflet,

to be coupled to a portion of the second native leaflet by the clip arms being brought together to close around the second native leaflet, and

to hold together the portion of the first leaflet and the portion of the second leaflet; and

placing the annular portion of the implant against the upstream surface of the native heart valve;

using a clip controller of the delivery apparatus, securing the annular portion against the upstream surface by coupling the at least one leaflet clip to the portion of the first native leaflet and to the portion of the second native leaflet such that the at least one leaflet clip holds together the portion of the first native leaflet and the portion of the second native leaflet, the clip controller being reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip; and

subsequently, intracorporeally decoupling the delivery apparatus from the implant.

17. The method according to claim 16 , wherein coupling the at least one leaflet clip to the portion of the first native leaflet and to the portion of the second native leaflet comprises using the at least one leaflet clip to arrange the first native leaflet and the second native leaflet to define two orifices between the first native leaflet and the second native leaflet, each orifice configured to function as a respective check-valve.

18. The apparatus according to claim 1 , wherein the clip is configured such that opening and closing of the clip comprises changing a relative angular disposition between the clip arms.

19. The apparatus according to claim 1 , wherein:

the annular portion has a compressed configuration and an expanded configuration,

while the annular portion is in the compressed configuration, the implant is transluminally deliverable, by the delivery apparatus, into the subject, and

the annular portion is configured to automatically expand into an expanded configuration upon intracorporeal deployment of the annular portion from the delivery apparatus.

20. The apparatus according to claim 1 , wherein each leaflet clip further comprises a tissue-engaging portion articulatably coupled to one of the clip arms of the leaflet clip, and facing another one of the clip arms of the leaflet clip.

21. The apparatus according to claim 1 , wherein the annular portion is generally flat.

Assignments (3)
SECURITY INTEREST Recorded Jun 10, 2021
From: CARDIOVALVE LTD.
To: BEST, LAWRENCE C.; OXO CAPITAL VALVE VENTURES LLC; PEREGRINE VC INVESTMENTS IV (IL) L.P.; PEREGRINE VC INVESTMENTS IV (US INVESTORS) L.P; PEREGRINE VC INVESTMENTS IV (OTHER INVESTORS) L.P.; NGN BIOMED OPPORTUNITY II, L.P.; IF A PE FUND II, LP; IF A PE FUND II US, LP
Reel/Frame 056539/0833 →
CHANGE OF NAME Recorded Oct 18, 2018
From: MITRALTECH LTD.
To: CARDIOVALVE LTD.
Reel/Frame 047208/0108 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 19, 2016
From: GROSS, YOSSI; ZIPORY, YUVAL; HACOHEN, GIL; REICH, TAL; MILLER, ERAN; KUTZIK, MEIR; NEEMAN, ROTEM
To: MITRALTECH LTD.
Reel/Frame 039782/0421 →
Continuity (8)
Continuation 14237258
Continuation In Part 13412814 · Mar 6, 2012
Provisional Application 61588892 · Jan 20, 2012
Provisional Application 61555160 · Nov 3, 2011
Provisional Application 61537276 · Sep 21, 2011
Provisional Application 61525281 · Aug 19, 2011
Provisional Application 61515372 · Aug 5, 2011
Related Publication 20160310274A1 · Oct 27, 2016
Cited By (11)
US 12,213,879 US 12,232,958 US 12,310,575 US 12,357,459 US 12,396,848 US 12,396,851 US 12,414,855 US 12,458,493 US 12,569,335 US 12,611,305 US 12,714,563