Percutaneous mitral valve replacement and sealing

• US 9,387,078 B2
• Filed: 08/05/2012
• Issued: 07/12/2016
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval, Reich, Tal, Kutzik, Meir, Neeman, Rotem
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US14/237,258
• Publication Number:
  US 20140257475A1
• Time in Patent Office: 1,437 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• 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

Apparatus is provided for use with a prosthetic valve for implantation at a native valve of a subject, the native valve including at least one native leaflet, the apparatus including (1) a prosthetic valve support, including (a) an upstream support portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening that is configured to receive the prosthetic valve, and (b) at least one clip (i) comprising at least two clip arms and a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and (ii) being configured to be coupled to a native leaflet of the native valve; and (2) at least one clip controller, reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip. Other embodiments are also described.

Claims

1. Apparatus for use with a prosthetic valve for implantation at a native valve of a subject, the native valve including at least one native leaflet, the apparatus comprising:

a prosthetic valve support, comprising;

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

at least one clip;

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

being configured to be coupled to a native leaflet of the native valve; and

at least one clip controller, reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip,

wherein the clip is flexibly coupled to the upstream support portion via a flexible connector, the flexible connector having a length from the upstream support portion to the clip, and wherein the length of the flexible connector is variable.

2. The apparatus according to claim 1, wherein the at least two clip arms comprise a first clip arm, configured to be disposed against an upstream surface of the leaflet, and a second clip arm, configured to be disposed against a downstream surface of the leaflet.

3. 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 expansion of the prosthetic valve support.

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 second clip is openable and closeable independently of the first clip.

5. 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.

6. The apparatus according to claim 1, wherein the at least one clip is configured to be coupled to a single native leaflet of the native valve.

7. The apparatus according to claim 1, wherein the at least one clip comprises a locking element, configured to lock the first clip arm with respect to the second clip arm.

8. The apparatus according to claim 1, wherein the apparatus is for use with the prosthetic valve for implantation at the native valve of the subject, the native valve including at least a first native leaflet and a second native leaflet, and wherein:

the at least one clip comprises at least a first clip and a second clip, the first clip being configured to be coupled to the first leaflet, and the second clip being configured to be coupled to the second leaflet, and

the prosthetic valve support is configured such that, when (1) the upstream support portion is disposed against the upstream side of the native valve, (2) the first clip is coupled to the first leaflet, and (3) the second clip is coupled to the second leaflet, the first clip moves toward the second clip during ventricular systole of the subject, and moves away from the second clip during ventricular diastole of the subject.

9. The apparatus according to claim 1, wherein the upstream support portion is generally flat.

10. 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.

11. The apparatus according to claim 1, wherein the upstream support portion has a free inner edge, and wherein the free inner edge defines the inner perimeter.

12. The apparatus according to claim 1, wherein the inner perimeter defines an opening that has a diameter, and wherein the upstream support portion has a diameter that is at least 10 percent greater than the diameter of the opening.

13. The apparatus according to claim 1, wherein no part of the prosthetic valve support that circumscribes a space that has a perimeter greater than 60 mm has a height of more than 20 mm.

14. The apparatus according to claim 5, wherein the first clip is configured to be intracorporeally decoupled from the second clip.

15. The apparatus according to claim 5, wherein:

the prosthetic valve support is configured to be transluminally advanced to the native valve while the first clip is fixedly coupled to the second clip, and

the first and second clips are configured to be coupled to respective native leaflets of the at least one native leaflet while the first clip is fixedly coupled to the second clip.

16. Apparatus for use at a native valve of a heart of a subject, the native valve including one or more leaflets, the apparatus comprising:

an upstream support portion;

having a delivery state in which the upstream support portion is dimensioned to be transluminally advanced to the heart, and

having an expanded state in which the upstream support portion is annular and configured to be disposed against an annulus of the native valve;

at least two connectors;

at least two clips, each of the clips;

coupled to the upstream support portion via a respective one of the connectors,

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

configured to be coupled to one of the leaflets by clamping the leaflet between the clip arms; and

a clip controller, reversibly couplable to the clip-controller interface of at least one of the clips, and configured to facilitate opening and closing of the at least one of the clips,

wherein the apparatus is configured such that the coupling of the clips to the leaflets secures the upstream support portion against an upstream side of the native valve.

17. The apparatus according to claim 16, wherein the connectors are flexible.

18. The apparatus according to claim 16, wherein the connectors comprise a fabric.

19. The apparatus according to claim 16, wherein the at least one of the clips is openable and closeable by the clip controller while the upstream support portion is in the delivery state.

20. The apparatus according to claim 16, wherein the one or more leaflets include a first leaflet and a second leaflet, the at least two clips comprise at least a first clip and a second clip, the first clip is couplable to the first leaflet, and the second clip is couplable to the second leaflet.

21. The apparatus according to claim 20, wherein the apparatus is configured such that, when the first clip is coupled to the first leaflet and the second clip is coupled to the second leaflet, the clips arrange the leaflets to define two orifices, each orifice (a) defined by a respective portion of the first leaflet and a respective portion of the second leaflet, and (b) configured to function as a check-valve.

22. The apparatus according to claim 20, wherein the second clip is openable and closeable independently of the first clip.

23. The apparatus according to claim 20, wherein the first clip is fixedly coupled to the second clip.

24. The apparatus according to claim 23, wherein the first clip is configured to be intracorporeally decoupled from the second clip.

25. The apparatus according to claim 16, wherein the apparatus is configured not to eliminate check-valve functionality of the native valve when the clips are coupled to the leaflets and the upstream support portion is secured against the upstream side of the native valve.

26. The apparatus according to claim 16, wherein each connector has a length between the upstream support portion and the respective clip, and is configured such that the length is variable.

27. The apparatus according to claim 26, wherein each connector is elastic.

28. The apparatus according to claim 26, wherein each connector is configured such that the length is manually and intracorporeally adjustable.

29. A method, comprising:

transluminally advancing an upstream support portion, in a delivery state thereof, to a heart of a subject;

placing the upstream support portion, in an annular expanded state thereof, against an annulus of a native valve of the heart; and

using at least one clip controller;

coupling a first clip to a first leaflet of the native valve, the at least one clip controller being reversibly coupled to a clip-controller interface of the first clip; and

coupling a second clip to a second leaflet of the native valve, the at least one clip controller being reversibly coupled to a clip-controller interface of the second clip,

each of the clips being coupled to the upstream support portion via a respective flexible connector.

30. The method according to claim 29, wherein transluminally advancing comprises advancing the upstream support portion transfemorally to the heart and transseptally into the left atrium.

31. Apparatus for use with a prosthetic valve for implantation at a native valve of a subject, the native valve including at least one native leaflet, the apparatus comprising:

a prosthetic valve support, comprising;

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

at least one clip;

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

being configured to be coupled to a native leaflet of the native valve; and

at least one clip controller, reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip,

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.

32. Apparatus for use at a native valve of a heart of a subject, the native valve including one or more leaflets, the apparatus comprising:

an upstream support portion;

having a delivery state in which the upstream support portion is dimensioned to be transluminally advanced to the heart, and

having an expanded state in which the upstream support portion is annular and configured to be disposed against an annulus of the native valve;

at least two connectors;

at least two cops, each of the clips;

coupled to the upstream support portion via a respective one of the connectors,

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

configured to be coupled to one of the leaflets by clamping the leaflet between the clip arms; and

a clip controller, reversibly couplable to the clip-controller interface of at least one of the cups, and configured to facilitate opening and closing of the at least one of the caps,

wherein the one or more leaflets include a first leaflet and a second leaflet, the at least two cups comprise at least a first clip and a second clip, the first clip is couplable to the first leaflet, and the second clip is couplable to the second leaflet.

33. The apparatus according to claim 32, wherein the apparatus is configured such that, when the first clip is coupled to the first leaflet and the second clip is coupled to the second leaflet, the clips arrange the leaflets to define two orifices, each orifice (a) defined by a respective portion of the first leaflet and a respective portion of the second leaflet, and (b) configured to function as a check-valve.

34. The apparatus according to claim 32, wherein the second clip is openable and closeable independently of the first clip.

35. The apparatus according to claim 32, wherein the first clip is fixedly coupled to the second clip.

36. Apparatus for use at a native valve of a heart of a subject, the native valve including one or more leaflets, the apparatus comprising:

an upstream support portion;

having a delivery state in which the upstream support portion is dimensioned to be transluminally advanced to the heart, and

having an expanded state hi which the upstream support portion is annular and configured to be disposed against an annulus of the native valve;

at least two connectors;

at least two clips, each of the clips;

coupled to the upstream support portion via a respective one of the connectors,

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

configured to be coupled to one of the leaflets by clamping the leaflet between the clip arms; and

a clip controller, reversibly couplable to the clip-controller interface of at least one of the clips, and configured to facilitate opening and closing of the at least one of the clips,

wherein each connector has a length between the upstream support portion and the respective clip, and is configured such that the length is variable.

37. The apparatus according to claim 36, wherein each connector is elastic.

38. The apparatus according to claim 36, wherein each connector is configured such that the length is manually and intracorporeally adjustable.