Methods and systems for heart valve therapy

• US 10,117,741 B2
• Filed: 07/21/2016
• Issued: 11/06/2018
• 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:
  US15/215,722
• Publication Number:
  US 20160324632A1
• Time in Patent Office: 838 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 a native mitral valve with native mitral valve leaflets that provide a valve function for closing during systole and opening to flow during diastole at an annulus between a left atrium and a left ventricle, the system comprising:

an anchor assembly movable from a compressed configuration for trans-catheter delivery into the left atrium to an expanded configuration for engagement with the annulus and with a sub-annular gutter adjacent to where the native mitral valve leaflets remain attached to the annulus, the anchor assembly having an expandable frame comprising;

(i) at least three sub-annular anchor feet, (ii) a sub-annular hub coupled by support arms to the at least three sub-annular anchor feet, and (iii) a supra-annular apron structure positionable in the left atrium while the at least three sub-annular anchor feet are positioned in the sub-annular gutter; and

an artificial valve assembly having a tri-leaflet structure for controlling blood flow and a frame expandable from a first configuration for trans-catheter delivery of the artificial valve assembly into the left atrium while the anchor assembly is in the expanded configuration to an operative configuration in which the artificial valve assembly is mechanically attached with the anchor assembly;

wherein the anchor assembly is movable to the expanded configuration, before said trans-catheter delivery of the artificial valve assembly, to engage with the annulus and the sub-annular gutter.

2. The system of claim 1, wherein the expandable frame of the anchor assembly defines four sub-annular anchor feet spaced relative to one another to deploy in the sub-annular gutter.

3. The system of claim 2, 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.

4. The system of claim 3, wherein a first pair of the four sub-annular anchor feet is spaced apart by a first distance of 30 mm to 40 mm.

5. The system of claim 4, 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.

6. The system of claim 2, wherein the four sub-annular anchor feet of the anchor assembly leave the leaflets of the mitral valve unaffected and the anchor assembly does not interrupt leaflet, chordea, or native valve function of the mitral valve prior to placement of the artificial valve assembly.

7. The system of claim 1, wherein the expandable frame of the anchor assembly comprises a first nickel titanium alloy wire construction that is movable between the compressed configuration and the expanded configuration, and wherein the 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.

8. The system of claim 1, wherein the expandable frame of the anchor assembly comprises wire arms that extend between the supra-annular apron 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 commissure of the native mitral valve leaflets.

9. 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 apron structure while the sub-annular anchor feet are positioned in the sub-annular gutter.

10. The system of claim 9, wherein the sub-annular hub of the anchor assembly defines a releasable connector for a delivery instrument.

11. The system of claim 1, wherein the expandable frame of the anchor assembly defines a supra-annular holding structure shaped to mechanically interlock with the artificial valve assembly by expansion of the artificial valve assembly to the operative configuration within the supra-annular holding structure.

12. The system of claim 11, wherein the valve assembly comprises scalloped arches configured to reside in a supra-annular position when the artificial valve assembly is expanded to the operative configuration.

13. The system of claim 11, wherein the frame of the artificial valve assembly defines both an inner circular valve orifice with said tri-leaflet structure directly attached thereto 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 holding structure of the anchor assembly.

14. The system of claim 1, further comprising:

a deflectable access catheter sized to be positioned across an atrial septum for access to the left atrium, an inner 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.

15. The system of claim 14, wherein the inner 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.

16. The system of claim 15, wherein the control instruments of the inner 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.

17. A trans-catheter mitral valve replacement system for a native mitral valve with a valve function for closing during systole and opening to flow during diastole at an annulus between a left atrium and a left ventricle, the system comprising:

an anchor assembly movable from a compressed configuration for trans-catheter delivery into the left atrium to an expanded configuration for engagement with the annulus and a sub-annular gutter adjacent to where native mitral valve leaflets meet the annulus, the anchor assembly having an expandable frame comprising;

(i) at least three sub-annular anchor feet, (ii) a sub-annular hub coupled by support arms to the at least three sub-annular anchor feet, and (iii) a supra-annular apron structure positionable in the left atrium while the at least three sub-annular anchor feet are positioned in the sub-annular gutter; and

an artificial valve assembly having a tri-leaflet structure for controlling blood flow and a frame expandable from a first configuration for trans-catheter delivery of the artificial valve assembly into the left atrium while the anchor assembly is in the expanded configuration to an operative configuration in which the artificial valve assembly is mechanically attached with the anchor assembly,

wherein the anchor assembly is movable to the expanded configuration, before said trans-catheter delivery of the artificial valve assembly, to engage with the annulus and the sub-annular gutter, and

wherein the supra-annular apron structure is positionable in the left atrium while the support arms extend downwardly away from the at least three sub-annular anchor feet positioned in the sub-annular gutter toward the sub-annular hub.

18. The system of claim 17, wherein the expandable frame of the anchor assembly comprises wire arms that extend between the supra-annular apron 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 commissure of the native mitral valve leaflets.

19. The system of claim 17, wherein the expanded configuration the anchor assembly is configured for engagement with the annulus and with the sub-annular gutter while the native mitral valve leaflets remain attached to the annulus.

20. The system of claim 17, wherein the anchor assembly and the artificial valve assembly are configured for percutaneous trans-catheter delivery.