Methods and systems for heart valve therapy

• US 10,736,736 B2
• Filed: 10/03/2018
• Issued: 08/11/2020
• Est. Priority Date: 10/23/2013
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Schweich, Jr., Cyril J., Mortier, Todd J.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US16/150,822
• Publication Number:
  US 20190029814A1
• Time in Patent Office: 678 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

Systems and methods for medical interventional procedures, including approaches to valve implantation. In one aspect, the methods and systems involve a modular approach to mitral valve therapy.

Claims

1. A trans-catheter mitral valve replacement system for implantation at a native mitral valve between a left atrium and a left ventricle of a heart, the native mitral valve including native mitral valve leaflets connected to the left ventricle via chordae, the trans-catheter mitral valve replacement system comprising:

an anchor assembly expandable from a trans-catheter delivery configuration to an anchored configuration for engagement with a native mitral valve annulus and with a sub-annular gutter adjacent to where the native mitral valve leaflets remain attached to the annulus, the anchor assembly having a first expandable frame at least partially covered by a fabric material and comprising;

at least three sub-annular anchor feet, a supra-annular structure positionable in the left atrium while the at least three sub-annular anchor feet are positioned in the sub-annular gutter, and wire arms that extend between the supra-annular structure and the sub-annular anchor feet and that are spaced apart relative to one another such that two adjacent wire arms of the wire arms each extend through a respective commis sure of the native mitral valve leaflets; and

an artificial valve assembly comprising a second expandable frame and pericardial tissue material, the artificial valve assembly being positionable in a compressed condition radially inward of the anchor assembly and being expandable from the compressed condition to an operative condition in which the artificial valve assembly is mechanically attached with the anchor assembly,

wherein the first expandable frame of the anchor assembly comprises a sub-annular hub coupled by support arms to the at least three sub-annular anchor feet.

2. The system of claim 1, wherein the supra-annular structure is positionable in the left atrium while the support arms extend downwardly away from the at least three sub-annular anchor feet toward the sub-annular hub.

3. The system of claim 2, wherein the anchor assembly in anchored configuration provides engagement with the annulus and with the sub-annular gutter while the native mitral valve leaflets remain attached to the annulus.

4. The system of claim 1, wherein the sub-annular hub of the anchor assembly is positioned radially inward from the sub-annular anchor feet and the supra-annular apron structure, and positioned entirely inferior of the sub-annular anchor feet at a sub-annular end portion of the expandable frame opposite of the supra-annular structure while the sub-annular anchor feet are positioned in the sub-annular gutter.

5. The system of claim 4, wherein the sub-annular hub of the anchor assembly defines a releasable connector for a delivery instrument.

6. A trans-catheter mitral valve replacement system for implantation at a native mitral valve between a left atrium and a left ventricle of a heart, the native mitral valve including native mitral valve leaflets connected to the left ventricle via chordae, the trans-catheter mitral valve replacement system comprising:

an anchor assembly expandable from a trans-catheter delivery configuration to an anchored configuration for engagement with a native mitral valve annulus and with a sub-annular gutter adjacent to where the native mitral valve leaflets remain attached to the annulus, the anchor assembly having a first expandable frame at least partially covered by a fabric material and comprising;

at least three sub-annular anchor feet, a supra-annular structure positionable in the left atrium while the at least three sub-annular anchor feet are positioned in the sub-annular gutter, and wire arms that extend between the supra-annular structure and the sub-annular anchor feet and that are spaced apart relative to one another such that two adjacent wire arms of the wire arms each extend through a respective commis sure of the native mitral valve leaflets; and

an artificial valve assembly comprising a second expandable frame and pericardial tissue material, the artificial valve assembly being positionable in a compressed condition radially inward of the anchor assembly and being expandable from the compressed condition to an operative condition in which the artificial valve assembly is mechanically attached with the anchor assembly,

wherein the at least three sub-annular anchor feet of the anchor assembly are spaced apart so that the anchor assembly is configured to avoid disrupting the chordae and native mitral valve when positioned in the anchored configuration.

7. The system of claim 6, wherein the anchor assembly defines four sub-annular anchor feet spaced relative to one another to deploy in the sub-annular gutter.

8. The system of claim 7, wherein the four sub-annular anchor feet are each defined by a metallic loop structure having a terminal end and a fabric covering configured to engage in the sub-annular gutter.

9. The system of claim 8, wherein a first pair of the four sub-annular anchor feet is spaced apart by a first distance of 30 mm to 40 mm.

10. The system of claim 9, wherein the first pair of the four sub-annular anchor feet is spaced apart from a second pair of the four sub-annular anchor feet by a second distance of 20 mm to 33 mm.

11. The system of claim 7, wherein the four sub-annular anchor feet of the anchor assembly are spaced apart so that the anchor assembly is configured to avoid disrupting the chordae and native mitral valve when positioned in the anchored configuration.

12. The system of claim 6, wherein the first expandable frame of the anchor assembly comprises a first nickel titanium alloy wire construction that is movable between the trans-catheter delivery configuration and the anchored configuration, and wherein the second expandable frame of the artificial valve assembly comprises a second nickel titanium alloy wire construction that is expandable independently from the first nickel titanium alloy wire construction of the anchor assembly.

13. The system of claim 12, wherein the anchor assembly and the artificial valve assembly are configured for percutaneous trans-catheter delivery.

14. The system of claim 6, wherein the supra-annular structure includes a supra-annular holding structure shaped to mechanically interlock with the artificial valve assembly by expansion of the artificial valve assembly to the operative condition within the supra-annular structure.

15. The system of claim 14, wherein the second expandable frame of the artificial valve assembly defines both:

an inner circular valve orifice which is directly attached to a tri-leaflet structure, and an outer periphery having an outer cross-sectional shape different from a circular cross-sectional shape of the inner circular valve orifice so that the outer cross-sectional shape is configured to mate with the supra-annular holding structure of the anchor assembly.

16. The system of claim 6, wherein the artificial valve assembly comprises scalloped arches configured to reside in a supra-annular position when the artificial valve assembly is expanded to the operative condition.

17. The system of claim 6, further comprising:

a deflectable access catheter sized to be positioned across an atrial septum for access to the left atrium, a first catheter movable through the deflectable access catheter and having a distal end configured to releasably engage the anchor assembly for transcatheter delivery of the anchor assembly to the left atrium, and a valve delivery catheter movable through the deflectable access catheter and having a distal end configured to releasably engage the artificial valve assembly for transcatheter delivery of the artificial valve assembly to the left atrium.

18. The system of claim 17, wherein the first catheter includes control instruments to partially express the anchor assembly in the left atrium before the anchor assembly is advanced toward the annulus between the left atrium and the left ventricle.

19. The system of claim 18, wherein the control instruments of the first catheter are configured to fully express the anchor assembly after the anchor assembly is advanced through the annulus between the left atrium and the left ventricle.

20. A trans-catheter mitral valve replacement system for implantation at a native mitral valve between a left atrium and a left ventricle of a heart, the native mitral valve including native mitral valve leaflets connected to the left ventricle via chordae, the trans-catheter mitral valve replacement system comprising:

an anchor assembly expandable from a trans-catheter delivery configuration to an anchored configuration for engagement with a native mitral valve annulus and with a sub-annular gutter adjacent to where the native mitral valve leaflets remain attached to the annulus, the anchor assembly having a first expandable frame at least partially covered by a fabric material and comprising;

at least three sub-annular anchor feet, a supra-annular structure positionable in the left atrium while the at least three sub-annular anchor feet are positioned in the sub-annular gutter, and wire arms that extend between the supra-annular structure and the sub-annular anchor feet and that are spaced apart relative to one another such that two adjacent wire arms of the wire arms each extend through a respective commis sure of the native mitral valve leaflets; and

an artificial valve assembly comprising a second expandable frame and pericardial tissue material, the artificial valve assembly being positionable in a compressed condition radially inward of the anchor assembly and being expandable from the compressed condition to an operative condition in which the artificial valve assembly is mechanically attached with the anchor assembly,

wherein the anchor assembly defines four sub-annular anchor feet spaced relative to one another to deploy in the sub-annular gutter, and the four sub-annular anchor feet of the anchor assembly are spaced apart so that the anchor assembly is configured to avoid disrupting the chordae and native mitral valve when positioned in the anchored configuration.

21. The system of claim 20, wherein the four sub-annular anchor feet are each defined by a metallic loop structure having a terminal end and a fabric covering configured to engage in the sub-annular gutter.

22. The system of claim 21, wherein a first pair of the four sub-annular anchor feet is spaced apart by a first distance of 30 mm to 40 mm.

23. The system of claim 22, wherein the first pair of the four sub-annular anchor feet is spaced apart from a second pair of the four sub-annular anchor feet by a second distance of 20 mm to 33 mm.

24. The system of claim 20, wherein the first expandable frame of the anchor assembly comprises a first nickel titanium alloy wire construction that is movable between the trans-catheter delivery configuration and the anchored configuration, and wherein the second expandable frame of the artificial valve assembly comprises a second nickel titanium alloy wire construction that is expandable independently from the first nickel titanium alloy wire construction of the anchor assembly.

25. The system of claim 24, wherein the anchor assembly and the artificial valve assembly are configured for percutaneous trans-catheter delivery.

26. The system of claim 20, wherein the supra-annular structure includes a supra-annular holding structure shaped to mechanically interlock with the artificial valve assembly by expansion of the artificial valve assembly to the operative condition within the supra-annular structure.

27. The system of claim 26, wherein the second expandable frame of the artificial valve assembly defines both:

an inner circular valve orifice which is directly attached to a tri-leaflet structure, and an outer periphery having an outer cross-sectional shape different from a circular cross-sectional shape of the inner circular valve orifice so that the outer cross-sectional shape is configured to mate with the supra-annular holding structure of the anchor assembly.

28. The system of claim 20, wherein the artificial valve assembly comprises scalloped arches configured to reside in a supra-annular position when the artificial valve assembly is expanded to the operative condition.