Prosthetic mitral valve, and methods and devices for deploying the prosthetic mitral valve

• US 10,500,038 B1
• Filed: 05/20/2012
• Issued: 12/10/2019
• Est. Priority Date: 05/20/2011
• Status: Active Grant

• Current Assignee: Tel Hashomer Medical Research Infrastructure And Services Ltd.
• Original Assignee: Tel Hashomer Medical Research Infrastructure And Services Ltd.
• Inventors: Orlov, Boris, Raanani, Ehud
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US13/475,994
• Time in Patent Office: 2,760 Days
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

According to an aspect of some embodiments of the invention, there is provided a method of deploying an expandable prosthetic mitral valve in a subject, the method comprising: deploying a first component of the prosthetic mitral valve in a left atrium; deploying a second component of the prosthetic mitral valve in a left ventricle; and approximating the first and the second components so that leaflets of a native mitral valve are trapped between the first and the second components.

Claims

1. A method of deploying an expandable prosthetic mitral valve device in a subject, said method comprising:

deploying a first component of said prosthetic mitral valve device in a left atrium, the first component including an annulus part;

deploying a second component of said prosthetic mitral valve in a left ventricle, the second component including a ventricle part; and

approximating said first and said second components so that one or more leaflets of a native mitral valve are trapped between said first and said second components,

the method being performed using apparatus comprising;

the prosthetic mitral valve device for fitted insertion to a native mitral valve annulus of a heart of the subject, the prosthetic mitral valve comprising the annulus part and the ventricle part; and

a deployment device for deployment of the prosthetic mitral valve device, the deployment device comprising;

a delivery housing configured to house the annulus part and the ventricle part of the prosthetic mitral valve device in radially-compact configurations, wherein;

the annulus part and the ventricle part are each configured to be radially expandable subsequent to release from the delivery housing, and

the expanded ventricle part and the expanded annulus part are shaped to mate in a deployed mating configuration, such that there is a gap between the ventricle part and the annulus part, the gap being configured to accommodate one or more leaflets of the native mitral valve; and

an approximator that is configured, while attached to both the annulus part and the ventricle part;

to force each of the annulus part and the ventricle part toward the other from initially separated positions into the mating configuration, such that the one or more leaflets of the native mitral valve are held within the gap between the ventricle part and the annulus part; and

to secure the annulus part and the ventricle part in the mating configuration.

2. A method according to claim 1, wherein said approximating comprises approximating by pulling a wire connecting said first and second elements.

3. A method according to claim 1, further comprising joining said first and second elements to maintain an approximated position.

4. A method according to claim 1, wherein said approximating comprises tightly trapping said native mitral valve leaflets.

5. A method according to claim 1, further comprising piercing said leaflets by at least one of said first or said second components.

6. A method according to claim 1, further comprising piercing tissues surrounding said leaflets by at least one of said first or said second components.

7. A valve deployment system comprising:

a prosthetic mitral valve device for fitted insertion to a native mitral valve annulus of a heart, the prosthetic mitral valve comprising an annulus part and a ventricle part; and

a deployment device for deployment of the prosthetic mitral valve device, the deployment device comprising;

a delivery housing configured to house the annulus part and the ventricle part of the prosthetic mitral valve device in radially-compact configurations, wherein;

the annulus part and the ventricle part are each configured to be radially expandable subsequent to release from the delivery housing, and

the expanded ventricle part and the expanded annulus part are shaped to mate in a deployed mating configuration, such that there is a gap between the ventricle part and the annulus part, the gap being configured to accommodate one or more leaflets of the native mitral valve; and

an approximator that is configured, while attached to both the annulus part and the ventricle part;

to force each of the annulus part and the ventricle part toward the other from initially separated positions into the mating configuration, such that the one or more leaflets of the native mitral valve are held within the gap between the ventricle part and the annulus part; and

to secure the annulus part and the ventricle part in the mating configuration.

8. The valve deployment system of claim 7, wherein said annulus part includes a valve mechanism suitable for functioning as a prosthetic mitral valve.

9. The valve deployment system of claim 7, further comprising an annulus-part expansion assembly, configured to apply a radially outwards force to an inner surface of said annulus part subsequent to release from said delivery housing to radially expand said annulus part from the radially-compact configuration.

10. The valve deployment system of claim 9, wherein said annulus part and said annulus-part expansion assembly are together configured so that said expanded annulus part conforms to an atrial contour near a native mitral valve of said mitral valve annulus.

11. The valve deployment system of claim 7, wherein said annulus part is self-expanding from the radially-compact configuration subsequent to release from said delivery housing.

12. The valve deployment system of claim 11, wherein said expanded annulus part is configured to dynamically conform to an atrial contour near a native mitral valve of said mitral valve annulus.

13. The valve deployment system of claim 7, further comprising a ventricle-part expansion assembly, configured to apply a radially outwards force to an inner surface of said ventricle part subsequent to release from said delivery housing to radially expand said ventricle part from the radially-compact configuration.

14. The valve deployment system of claim 7, wherein said ventricle part is self-expanding from the radially-compact configuration subsequent to release from said delivery housing.

15. The valve deployment system of claim 7, wherein the approximator comprises at least one elongated tether having a distal end functionally associated with said annulus part and a proximal end configured for securing in proximity of an apex of said heart, so that a force applied to said proximal end of said tether is at least partially transferred by said annulus part to an atrial surface near said native mitral valve annulus.

16. The valve deployment system of claim 7, wherein the approximator comprises at least one elongated tether having a distal end functionally associated with said ventricle part and a proximal end configured for securing in proximity of an apex of said heart, wherein a portion of said tether passes through said annulus part so that force applied to said proximal end of said tether pulls said ventricle part towards said annulus part, and is at least partially transferred by said annulus part to an atrial surface near said native mitral valve annulus.

17. The valve deployment system of claim 7, further comprising an annulus-part placement component functionally associated with said annulus part, configured to assist in properly positioning said annulus part in said native mitral valve annulus.

18. The valve deployment system of claim 17, said annulus-part placement component being configured to also function as a deployable tether.

19. The valve deployment system of claim 7, wherein at least one of said annulus part and said ventricle part include bending mating features, configured to be bent when said annulus part and said ventricle part are mated, and wherein said approximator is configured to bend said bending mating features.

20. The valve deployment system of claim 7, wherein said approximator is further configured to function as a ventricle-part release component.

21. The valve deployment system of claim 7, wherein said approximator is further configured to function as an annulus-part placement component.

22. The valve deployment system of claim 7, wherein said approximator is further configured to function as a deployable tether.

23. The valve deployment system of claim 7, wherein:

the expanded ventricle part and the expanded annulus part are shaped to mate in the deployed mating configuration, such that the ventricle part radially encircles the annulus part around a circumference of the annulus part surrounding and defining an annulus; and

said radial encircling is at a position at which the annulus part and the ventricle part are configured to hold the one or more leaflets of said native mitral valve annulus within the gap between said ventricle part and said annulus part when the valve is deployed with the annulus and ventricle parts in the mating configuration.

24. The valve deployment system of claim 7, wherein the expanded annulus part and the expanded ventricle part each narrow from wider to narrower between their respective distal and proximal portions, the proximal portions being configured to be positioned further in a direction toward the ventricle in the deployed configurations of the annulus and ventricle parts, and the ventricle part is configured to radially encircle the proximal portion of said annulus part in the deployed configurations of the annulus and ventricle parts.

25. The valve deployment system of claim 7, wherein the approximator operates to pull the ventricle part toward the annulus part to a position on a ventricular side of the prosthetic mitral valve, such that the ventricle part, at said position, is configured to at least partially encircle both a proximal portion of the annulus part and the one or more leaflets of the native mitral valve.

26. The valve deployment system of claim 7, wherein the deployment device is operable to deploy the prosthetic mitral valve device using at least one of a transapical approach, or a vascular approach.

27. The valve deployment system of claim 7, wherein the deployment device is operable to deploy the prosthetic mitral valve via a transseptal approach.

28. The valve deployment system of claim 7, wherein the approximator comprises a plurality of filaments each of which extends from the deployment device at one filament end to another filament end that is secured to the ventricle part, each of the filaments contacting a region of slidable association with the annulus part between the filament ends.

29. The valve deployment system of claim 28, wherein said approximator is configured to be releasably secured to said ventricle part.

30. The valve deployment system of claim 28, wherein said approximator is configured to be fixedly secured to said ventricle part.