PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATED SYSTEMS AND METHODS

• US 20130317603A1
• Filed: 07/19/2013
• Published: 11/28/2013
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Foundry Newco XII, Inc. (Medtronic Plc)
• Inventors: McLean, Matt, Morriss, John, Gifford, Hanson III
• Granted Patent: US 9,034,033 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

Devices and methods for implantation at a native mitral valve having a non-circular annulus and leaflets. One embodiment of the device includes a valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets and a second region, and an anchoring member having a longitudinal dimension with a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion transverse to the longitudinal dimension between the first portion and the second portion. The anchoring member and the valve support are configured to move from a low-profile configuration to an expanded configuration in which a shape of the first region of the valve support is at least partially independent of a shape of the first portion of the anchoring member.

Claims

1. A method for replacing a native mitral heart valve having a native annulus and native leaflets with a prosthetic heart valve device having a valve support, a valve coupled to the valve support, and an anchoring member with a fixation portion having a first cross-sectional shape in a fully expanded an unbiased condition, a connection structure having an inner portion coupled to the valve support and an outer portion coupled to the fixation portion, and a transition zone from which the fixation portion extends from the outer portion of the connection structure, the method comprising:

delivering the prosthetic heart valve in a low-profile delivery configuration into a chamber of the heart through a blood vessel or through a conduit extending through a wall of the heart;

positioning the prosthetic heart valve device near the native mitral valve; and

expanding the prosthetic heart valve device to an expanded configuration in which at least a portion of the connection structure extends in a first direction transverse to a direction of blood flow through the native mitral valve and the fixation portion extends from the transition zone in a second direction different than the first direction, wherein the fixation portion engages inward-facing surface of the native leaflets.

2. The method of claim 1 wherein, in the expanded configuration, the connection structure flares outwardly toward the atrium of the human from the inner portion to the outer portion such that the valve support is spaced radially inwardly from the fixation portion and the connection portion contacts inward-facing surface of the native leaflets.

3. The method of claim 2 wherein the fixation portion deflects inwardly relative to the connection structure in the expanded configuration such that the fixation portion is inclined toward the valve support.

4. The method of claim 1 wherein:

the inner portion of the connection structure is attached to the valve support near a downstream end thereof toward the left ventricle and the outer portion of the connection structure flares outwardly from the inner portion in the expanded configuration; and

the fixation portion comprises a cylindrical fixation ring having an outwardly facing engagement surface that extends generally longitudinally relative to a longitudinal axis of the valve support in the expanded configuration.

5. The method of claim 4 wherein the fixation portion extends generally parallel to a longitudinal axis of the valve support.

6. The method of claim 4 wherein the fixation portion extends in an upstream direction at an angle tilted inwardly toward the valve support.

7. The method of claim 1 wherein the prosthetic heart valve device has a prosthetic valve mounted in an upstream portion of the valve support and the fixation portion is mechanically isolated from an upstream portion of the valve support such that prosthetic leaves of the prosthetic valve maintain sufficient contact with each other to inhibit backflow of blood through the valve support when the prosthetic heart valve device is in the expanded configuration at the native mitral valve.

8. The method of claim 7 wherein:

the inner portion of the connection structure is attached to the valve support near a downstream end thereof toward the left ventricle and the outer portion of the connection structure flares outwardly from the inner portion in the expanded configuration; and

the fixation portion comprises a cylindrical fixation ring having an outwardly facing engagement surface that extends generally longitudinally relative to a longitudinal axis of the valve support in the expanded configuration.

9. The method of claim 8 wherein the fixation portion deflects relative to the connection structure at the transition zone when the engagement surface is in contact with the native annulus.

10. The method of claim 8 further comprising creating a seal between the fixation portion and the tissue with a skirt covering an inward-facing surface of the fixation portion.

11. A method for replacing a native heart valve having an annulus and leaflet extending from the annulus, comprising:

positioning a prosthetic heart valve device at a native mitral valve location in a heart of a human, wherein the prosthetic heart valve device comprises an anchoring member and a valve support, the anchoring member includes a connection structure and a fixation portion, the connection structure includes an inner end at the valve support and an outer end, the fixation portion extends from the outer end of the connection structure, and the fixation structure includes an outwardly-facing surface configured to extend from the connection structure at a first angle in an expanded unbiased state; and

expanding the prosthetic heart valve device such that at least a portion of the connection structure flares outwardly in a transverse direction relative to blood flow through the native mitral valve, the fixation portion deflects relative to the outer end of the connection structure to extend from the connection structure at a second angle different than the first angle as the outwardly-facing surface of the fixation portion contacts tissue at or downstream of the native annulus, and an upstream portion of the valve support is spaced inwardly apart from the fixation portion.

12. The method of claim 11 wherein, upon expansion, the valve support is spaced inwardly apart from the fixation portion.

13. The method of claim 11 wherein, upon expansion, the valve support has a substantially cylindrical shape.

14. The method of claim 11 wherein the prosthetic heart valve device further comprises prosthetic leaflets coupled to the valve support, and the prosthetic leaflets contact each other sufficiently to inhibit backflow through the prosthetic valve during ventricular systole while the fixation portion of the anchoring member contacts the native annulus of the native mitral valve.

15. The method of claim 14 wherein, the prosthetic leaflets are coupled to an upstream portion of the valve support and the upstream portion of the valve support is mechanically isolated from the fixation portion such that prosthetic leaflets contact each other sufficiently to inhibit backflow through the prosthetic valve during ventricular systole when the fixation portion is deformed in a non-circular shape.

16. The method of claim 11 wherein, upon expansion, the fixation portion has a non-circular shape while the valve support has a substantially cylindrical shape.

17. The method of claim 11 wherein, upon expansion, the outwardly-facing surface of the fixation portion extends generally parallel relative to a direction of blood flow through the native valve.

18. The method of claim 11 wherein, upon expansion, the anchoring member has a longitudinal axis, and the outwardly-facing surface of the fixation portion extends generally parallel to the longitudinal axis of the anchoring member.

19. The method of claim 11 wherein, upon expansion, the outwardly-facing surface of the fixation portion tapers inwardly in an upstream direction.

20. The method of claim 11 wherein the connection structure has a flared intermediate portion between the inner end and the outer end, and upon expansion the flared intermediate portion of the connection structure is disposed entirely downstream of the native annulus.

21. The method of claim 11 wherein, upon expansion, the outer end of the connection structure is an upstream end positioned downstream of the native annulus after the anchoring member has been secured to the native annulus.

22. The method of claim 11 wherein the connection structure has a flared intermediate portion between the inner end and the outer end, and upon expansion the outwardly-facing surface of the fixation portion contacts tissue at or downstream of the native annulus while the flared intermediate portion of the connection structure is disposed entirely downstream of the native annulus.

23. The method of claim 11 wherein, upon expansion, the anchoring member adequately secures the prosthetic heart valve device in the native annulus against the forces during ventricular systole.

24. The method of claim 11 wherein the connection structure comprises metal struts that drive the outwardly-facing surface of the fixation portion against the tissue when the left ventricle is pressurized during ventricular systole.

25. The method of claim 24 wherein the connection structure further comprises a flexible cover attached to the metal struts, and following expansion tissue grows onto the flexible cover.

26. The method of claim 11 wherein the connection structure comprises a flexible web and, following expansion, tissue grows onto the flexible web.

27. A method for replacement of a native heart valve having an annulus and leaflets coupled to the annulus, the method comprising:

positioning a prosthetic heart valve device including an anchoring member and a valve support at a native mitral valve location in a heart of the patient, wherein the anchoring member has a first portion and a second portion, and the valve support has a first region and a second region; and

expanding the anchoring member and the valve support while the second portion of the anchoring member is coupled to the second region of the valve support such that the first portion of the anchoring member engages tissue at or downstream of the annulus and at least partially adapts to a shape of the annulus at the native mitral valve location;

wherein, upon expansion, the first region of the valve support is spaced inwardly apart from the first portion of the anchoring member and the first region of the valve support holds a prosthetic valve having prosthetic leaflets such that the prosthetic leaflets contact each other sufficiently to inhibit backflow through the prosthetic valve after the first portion of the anchoring member has adapted to the shape of the annulus of the native mitral valve.

28. The method of claim 27 wherein the anchoring member further comprises a fixation portion having an engagement surface and, upon expansion, the engagement surface faces outwardly and contacts tissue at an implant site on or below a native annulus of the native heart valve.

29. The method of claim 27 wherein:

the anchoring member further comprises a connecting structure having an outer end coupled to the fixation portion, an inner end coupled to the valve support, and an intermediate portion between the outer end and the inner end; and

upon expansion the engagement surface of the fixation portion contacts tissue at or downstream of the native annulus, and the intermediate portion of the connection structure has a flared portion disposed entirely downstream of the native annulus.

30. The method of claim 27 wherein, upon expansion, the anchoring member adequately secures the prosthetic heart valve device in the native annulus against the forces during ventricular systole.