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1. (WO2018145055) SYSTEMS AND METHODS FOR HEART VALVE THERAPY
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WHAT IS CLAIMED IS:

1. A prosthetic mitral valve system comprising:

an anchor assembly comprising an expandable anchor frame and a prosthetic element attached to the expandable anchor frame, the anchor assembly coupleable with a native mitral valve having an anterior leaflet and a posterior leaflet that cycle between an open valve orientation and a closed valve orientation in which free edges of the anterior and posterior leaflets oppose each other to define a coaptation line, wherein while the anchor assembly is coupled with the native mitral valve: (i) the anterior and posterior leaflets continue to cycle and (ii) at least a portion of the prosthetic element is positioned along the coaptation line between the free edges of the anterior and posterior leaflets while the anterior and posterior leaflets are in the closed valve orientation; and

a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame, the valve assembly selectively coupleable with the anchor assembly.

2. The prosthetic mitral valve system of claim 1, wherein the prosthetic element is configured to function as a prosthetic posterior leaflet while the anchor assembly is coupled with the native mitral valve.

3. The prosthetic mitral valve system of claim 2, wherein the prosthetic element comprises a single, continuous member.

4. The prosthetic mitral valve system of claim 2, wherein the prosthetic element comprises multiple members that are not directly connected to each other.

5. The prosthetic mitral valve system of claim 2, wherein the prosthetic element comprises three members that are not directly connected to each other.

6. The prosthetic mitral valve system of claim 1, wherein the prosthetic element comprises flexible, sheet-like material.

7. The prosthetic mitral valve system of claim 1 , wherein the prosthetic element is attached to a portion of the expandable anchor frame that is positioned superior to an annulus of the native mitral valve while the anchor assembly is coupled with the native mitral valve.

8. The prosthetic mitral valve system of claim 7, further comprising one or more tethers attached to the prosthetic element and to a portion of the expandable anchor frame that is positioned inferior to the annulus of the native mitral valve while the anchor assembly is coupled with the native mitral valve.

9. The prosthetic mitral valve system of claim 1, wherein the prosthetic element comprises two or more separate members that are attached to the anchor assembly in a fully-circumferential arrangement.

10. The prosthetic mitral valve system of claim 9, wherein the prosthetic element comprises:

a first prosthetic element configured to function as a prosthetic posterior leaflet while the anchor assembly is coupled with the native mitral valve; and

a second prosthetic element configured to function as a prosthetic anterior leaflet while the anchor assembly is coupled with the native mitral valve.

11. The prosthetic mitral valve system of claim 9, wherein the prosthetic element comprises three separate prosthetic elements.

12. A prosthetic mitral valve and deployment system, comprising:

the prosthetic mitral valve comprising:

an anchor assembly comprising an expandable anchor frame coupleable with a native mitral valve having an anterior leaflet and a posterior leaflet that cycle between an open valve orientation and a closed valve orientation in which free edges of the anterior and posterior leaflets oppose each other to define a coaptation line, wherein while the anchor assembly is coupled with the native mitral valve the anterior and posterior leaflets continue to cycle: and

a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame, the valve assembly selectively coupleable with the anchor assembly; and

the deployment system comprising multiple catheters configured to deliver the prosthetic mitral valve, wherein at least some of the catheters are slidably engageable with each other and are releasably coupleable to the prosthetic mitral valve,

wherein a first catheter of the multiple catheters is releasably coupleable to the anchor assembly and includes an expandable element that is positioned along the coaptation line between the free edges of the anterior and posterior leaflets while: (i) the first catheter is coupled to the anchor assembly, (ii) the anchor assembly is coupled to the native mitral valve, and (iii) the anterior and posterior leaflets are in the closed valve orientation.

13. The system of claim 12, wherein the expandable element comprises a selectively expandable balloon.

14. The system of claim 12, wherein the expandable element comprises a self-expanding wireframe and a covering material attached thereto.

15. The system of claim 12, wherein the expandable element comprises a passively-expandable, flexible sock member.

16. The system of claim 12, wherein the anchor assembly comprises a hub that is positioned inferior to the annulus of the native mitral valve while the anchor assembly is coupled with the native mitral valve, and wherein the first catheter is releasably coupleable to the hub.

17. The system of claim 16, wherein a second catheter of the multiple catheters is slidably engaged over the first catheter and slidably engageable over the expandable element.

18. The system of claim 17, wherein the second catheter is releasably coupleable to the valve assembly.

19. The system of claim 12, wherein the expandable element comprises a selectively expandable balloon that is non-spherical when expanded.

20. The system of claim 12, wherein the expandable element comprises a first balloon and a second balloon, wherein the first balloon and the second balloon are each selectively expandable.

21. The system of claim 20, wherein the first balloon and the second balloon are each selectively expandable longitudinally and transversely in relation to the first catheter.

22. The system of claim 20, further comprising a manifold comprising a first nozzle and a second nozzle, wherein the first balloon is coupled to the first nozzle and the second balloon is coupled to the second nozzle.

23. The system of claim 22, wherein an axis of the first nozzle and an axis of the second nozzle are non-linear to one another.

24. The system of claim 23, wherein an angle between the axis of the first nozzle and the axis of the second nozzle is between 70 degrees and 110 degrees.

25. The system of claim 23, wherein the axis of the first nozzle and the axis of the second nozzle each extend radially from the first catheter.

26. A method for deploying a prosthetic mitral valve system within a native mitral valve having an anterior leaflet and a posterior leaflet that cycle between an open valve orientation and a closed valve orientation in which free edges of the anterior and posterior leaflets oppose each other to define a coaptation line, the method comprising:

navigating a delivery sheath of a prosthetic mitral valve delivery system through a vasculature of the patient such that a distal end of the delivery sheath is positioned adjacent the native mitral valve;

expressing an anchor assembly of the prosthetic mitral valve system from the distal end of the delivery sheath such that the anchor assembly at least partially expands, the anchor assembly configured to selectively mate with a valve assembly of the prosthetic mitral valve system, the anchor assembly comprising an expandable anchor frame and a prosthetic element attached to the expandable anchor frame; coupling the anchor assembly with the native mitral valve, wherein while the anchor assembly is coupled with the native mitral valve: (i) the anterior and posterior leaflets continue to cycle and (ii) at least a portion of the prosthetic element is positioned along the coaptation line between the free edges of the anterior and posterior leaflets while the anterior and posterior leaflets are in the closed valve orientation; and

mating the valve assembly with the anchor assembly, wherein the valve assembly comprises an expandable valve frame and an occluder attached to the expandable valve frame.

27. A method for using a catheter deployment system to deploy a prosthetic mitral valve system within a native mitral valve having an anterior leaflet and a posterior leaflet that cycle between an open valve orientation and a closed valve orientation in which free edges of the anterior and posterior leaflets oppose each other to define a coaptation line, the method comprising:

navigating a delivery sheath of the catheter deployment system through a vasculature of the patient such that a distal end of the delivery sheath is positioned adjacent the native mitral valve;

expressing an anchor assembly of the prosthetic mitral valve system from the distal end of the delivery sheath by extending a catheter distally in relation to the delivery sheath, the catheter releasably coupled to the anchor assembly, the anchor assembly configured to selectively mate with a valve assembly of the prosthetic mitral valve system, the anchor assembly comprising an expandable anchor frame, the catheter including an expandable element;

coupling the anchor assembly with the native mitral valve;

while the catheter is coupled to the anchor assembly and the anchor assembly is coupled with the native mitral valve, expanding the expandable element such that the expandable element is positioned along the coaptation line between the free edges of the anterior and posterior leaflets; and

mating the valve assembly with the anchor assembly.

28. A mitral valve system for deployment within a native mitral valve, comprising: valve means; and

means for anchoring the valve means within the native mitral valve annulus, the means for anchoring the valve means including an element for temporarily occluding regurgitation of blood flow from a left ventricle to a left atrium prior to receiving the valve means.

29. A transcatheter mitral valve replacement system comprising:

a valve assembly comprising an expandable valve frame and a set of occluder leaflets attached to the expandable valve frame; and

an anchor assembly comprising an expandable anchor frame and a prosthetic valve sealing element attached to the expandable anchor frame, the anchor assembly configured to anchor to a native mitral valve and to receivingly mate with the valve assembly.