Systems and methods for heart valve therapy

• US 10,265,166 B2
• Filed: 12/29/2016
• Issued: 04/23/2019
• Est. Priority Date: 12/30/2015
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Schweich, Jr., Cyril J., Ganesan, Kavitha, Iyer, Ramji, Martz, Erik O., Schneider, Lucas T., Mortier, Todd J.
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/393,704
• Publication Number:
  US 20170189177A1
• Time in Patent Office: 845 Days
• Field of Search: 623 11- 31
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. Some embodiments of prosthetic mitral valves described herein include an anchor portion that couples the prosthetic mitral valve to the anatomy near the native mitral valve, and a valve portion that is mateable with the anchor portion.

Claims

1. A prosthetic mitral valve system comprising:

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

an anchor assembly comprising an expandable anchor frame that defines a longitudinal axis, the anchor assembly configured to selectively couple with the valve assembly; and

a control wire slidably engaged with the expandable anchor frame at a plurality of engagement locations at a mid-body region along the longitudinal axis of the expandable anchor frame, the control wire being manipulable to increase and decrease a diameter of the expandable anchor frame during implantation of the anchor assembly.

2. The prosthetic mitral valve system of claim 1, wherein the expandable anchor frame comprises:

a centrally located hub;

a first elongate element extending from the hub, the first elongate element including a first foot;

a second elongate element extending from the hub, the second elongate element including a second foot;

a third elongate element extending from the first elongate element, the third elongate element including a third foot; and

a fourth elongate element extending from the second elongate element, the fourth elongate element including a fourth foot.

3. The prosthetic mitral valve system of claim 2, wherein tensioning the control wire draws each of the first foot, second foot, third foot, and fourth foot radially inwards towards the longitudinal axis, and wherein slackening the control wire allows each of the first foot, second foot, third foot, and fourth foot to expand radially outwards away from the longitudinal axis.

4. The prosthetic mitral valve system of claim 1, wherein the control wire is a first control wire, and further comprising a second control wire slidably engaged with the expandable anchor frame at a proximal end region of the expandable anchor frame.

5. The prosthetic mitral valve system of claim 4, wherein the proximal end region of the expandable anchor frame comprises a plurality of arched atrial holding features, and wherein the second control wire is manipulable such that tensioning the second control wire draws the plurality of arched atrial holding features radially inwards towards the longitudinal axis and slackening the second control wire allows the plurality of arched atrial holding features to extend transversely outward in relation to the longitudinal axis.

6. The prosthetic mitral valve system of claim 1, wherein:

the expandable valve frame comprises three valve frame lobes disposed on a proximal end portion of the expandable valve frame;

the expandable anchor frame comprises three anchor frame lobes disposed on a proximal end portion of the expandable anchor frame; and

wherein, while the valve assembly and the anchor assembly are coupled, each valve frame lobe of the three valve frame lobes is aligned with a respective anchor frame lobe of the three anchor frame lobes.

7. The prosthetic mitral valve system of claim 5, wherein:

the expandable valve frame comprises three valve frame lobes disposed on a proximal end portion of the expandable valve frame;

the expandable anchor frame comprises three anchor frame lobes disposed on a proximal end portion of the expandable anchor frame; and

wherein, while the valve assembly and the anchor assembly are coupled, each valve frame lobe of the three valve frame lobes is aligned with a respective anchor frame lobe of the three anchor frame lobes.

8. The prosthetic mitral valve system of claim 7, wherein the plurality of arched atrial holding features comprises three arched atrial holding features.

9. The prosthetic mitral valve system of claim 5, wherein the plurality of arched atrial holding features comprises three arched atrial holding features.

10. The prosthetic mitral valve system of claim 2, wherein the expandable anchor frame further comprises a systolic anterior motion containment member that is configured to be at least partially disposed behind an anterior leaflet of the native mitral valve while the anchor assembly is coupled to the native mitral valve.

11. The prosthetic mitral valve system of claim 10, wherein the systolic anterior motion containment member extends from the first elongate element and the second elongate element.

12. The prosthetic mitral valve system of claim 2, wherein the hub is located at a distal end of the expandable anchor frame.

13. The prosthetic mitral valve system of claim 12, wherein the hub is threaded for releasable attachment with a delivery device.

14. The prosthetic mitral valve system of claim 1, wherein the valve assembly comprises:

the expandable valve frame comprising an expandable metallic structure, an outer covering material along an exterior of the expandable metallic structure, and the occluder attached to the expandable metallic structure.

15. The prosthetic mitral valve system of claim 1, wherein the anchor assembly is configured to selectively couple with the valve assembly by expansion of the valve assembly within the anchor assembly subsequent to implantation of the anchor assembly.

16. The prosthetic mitral valve system of claim 15, wherein the valve assembly is deliverable to the anchor assembly after the anchor assembly is expanded and secured at an implantation site.

17. The prosthetic mitral valve system of claim 1, wherein the control wire is manipulable to increase and decrease the diameter of the expandable anchor frame during implantation of the anchor assembly prior to selectively coupling with the valve assembly with the anchor assembly.

18. The prosthetic mitral valve system of claim 17, wherein the control wire is removable from all of said plurality of engagement locations at the mid-body region of the expandable anchor frame to expand the anchor frame while the valve assembly is decoupled from the anchor assembly.

19. The prosthetic mitral valve system of claim 18, wherein the control wire is removable from all of said plurality of engagement locations at the mid-body region of the expandable anchor frame to expand the anchor frame while the valve assembly remains in a collapsed configuration.

20. The prosthetic mitral valve system of claim 1, wherein said control wire is removably and slidably engaged with at least two engagement locations at the mid-body region of the expandable anchor frame.

21. The prosthetic mitral valve system of claim 20, wherein said control wire is looped through at least four of engagement locations at the mid-body region of the expandable anchor frame.

22. The prosthetic mitral valve system of claim 1, wherein said control wire is movable to individually and exclusively control said decrease of the diameter of the expandable anchor frame during implantation of the anchor assembly.

23. The prosthetic mitral valve system of claim 4, wherein said second control wire is removably and slidably engaged with at least two engagement locations at the proximal end region of the expandable anchor frame, the second end wire being removable from the expandable anchor frame independently and separately from the first control wire.

24. The prosthetic mitral valve system of claim 4, further comprising a valve expansion control wire to slidably and removably connect with the expandable valve frame to control a diameter of the valve assembly independently from expansion of the anchor assembly.

25. The prosthetic mitral valve system of claim 24, wherein the valve expansion control wire is removable from the expandable valve frame independently and separately from removal of the first and second control wires from the expandable anchor frame.

26. A prosthetic mitral valve system comprising:

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

an anchor assembly comprising an expandable anchor frame that defines a longitudinal axis, the anchor assembly configured to selectively couple with the valve assembly; and

a control wire slidably engaged with the expandable anchor frame at a plurality of engagement locations at a mid-body region along the longitudinal axis of the expandable anchor frame, the control wire being manipulable to increase and decrease a diameter of the expandable anchor frame during implantation of the anchor assembly;

wherein the control wire is a first control wire, and further comprising a second control wire slidably engaged with the expandable anchor frame at a proximal end region of the expandable anchor frame;

wherein the proximal end region of the expandable anchor frame comprises a plurality of arched atrial holding features, and wherein the second control wire is manipulable such that tensioning the second control wire draws the plurality of arched atrial holding features radially inwards towards the longitudinal axis and slackening the second control wire allows the plurality of arched atrial holding features to extend transversely outward in relation to the longitudinal axis;

wherein;

the expandable valve frame comprises three valve frame lobes disposed on a proximal end portion of the expandable valve frame;

the expandable anchor frame comprises three anchor frame lobes disposed on a proximal end portion of the expandable anchor frame; and

wherein, while the valve assembly and the anchor assembly are coupled, each valve frame lobe of the three valve frame lobes is aligned with a respective anchor frame lobe of the three anchor frame lobes;

wherein the plurality of arched atrial holding features comprises three arched atrial holding features; and

wherein each arched atrial holding feature of the three arched atrial holding features is aligned with a corresponding valve frame lobe of the three valve frame lobes and with a corresponding anchor frame lobe of the three anchor frame lobes.

27. The prosthetic mitral valve system of claim 26, wherein the valve assembly comprises:

the expandable valve frame comprising an expandable metallic structure, an outer covering material along an exterior of the expandable metallic structure, and the occluder attached to the expandable metallic structure.

28. The prosthetic mitral valve system of claim 26, wherein the anchor assembly is configured to selectively couple with the valve assembly by expansion of the valve assembly within the anchor assembly subsequent to implantation of the anchor assembly.

29. The prosthetic mitral valve system of claim 26, wherein said control wire is manipulable to increase and decrease the diameter of the expandable anchor frame during implantation of the anchor assembly prior to selectively coupling with the valve assembly with the anchor assembly.

30. The prosthetic mitral valve system of claim 26, wherein the expandable anchor frame further comprises a systolic anterior motion containment member that is configured to be at least partially disposed behind an anterior leaflet of the native mitral valve while the anchor assembly is coupled to the native mitral valve.