Implant for heart valve

• US 10,226,341 B2
• Filed: 06/29/2016
• Issued: 03/12/2019
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval, Reich, Tal, Kutzik, Meir, Neeman, Rotem
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/197,069
• Publication Number:
  US 20160310274A1
• Time in Patent Office: 986 Days
• Field of Search: 623 21- 119
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/0071 : breakable or frangible

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

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.

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.

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.