Methods and systems for heart valve therapy

• US 9,421,094 B2
• Filed: 05/02/2014
• Issued: 08/23/2016
• 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, Cyril J. Jr., Mortier, Todd J.
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/268,094
• Publication Number:
  US 20150112433A1
• Time in Patent Office: 844 Days
• Field of Search: 623/2.38, 623 236- 237, 623/2.1, 623/2.14, 623 217- 218, 623/1.24, 623/1.26
• US Class Current: 1/1
• 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 mitral valve replacement system for a heart, the mitral valve including commissural clefts, an anterior leaflet, a posterior leaflet, an annulus and a sub-annular gutter, comprising:

an anchor assembly configured for placement within the heart, the anchor assembly including a retention structure and a plurality of projections, wherein the anchor assembly is movable between a compressed configuration and an expanded configuration, in which the retention structure is configured for placement at or proximate the mitral valve annulus, while the plurality of projections are placed into contact with the sub-annular gutter, and

an artificial valve comprising an expandable frame having a generally D-shaped outer peripheral region configured for engagement within the retention structure of the anchor assembly, and a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets directly attached to the circular valve orifice, wherein the expandable frame of the artificial valve is expandable from a collapsed configuration, while the anchor assembly remains in the expanded configuration, to a deployed configuration to selectively contact and mate with the retention structure of the anchor assembly;

wherein the anchor assembly leaves the leaflets of the mitral valve unaffected and the anchor assembly does not interrupt leaflet, chordae, or native valve function of the mitral valve prior to placement of the artificial valve.

2. The system of claim 1, wherein the anchor assembly is sized and shaped to be implanted without reshaping the annulus.

3. The system of claim 1, wherein the plurality of projections include a curved portion.

4. The system of claim 1, wherein 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 expandable frame of the artificial valve comprises a second nickel titanium alloy wire construction that is expandable independently from the first nickel titanium alloy wire construction of the anchor assembly.

5. The system of claim 1, wherein the artificial valve is configured to seal against natural tissue.

6. The system of claim 1, wherein the anchor assembly includes a supra-annular holding structure.

7. The system of claim 6, wherein the supra-annular holding structure comprises at least one of an apron and a visor.

8. The system of claim 1, further comprising providing a sealing element between the anchor assembly and the artificial valve, wherein the sealing element is configured to promote tissue ingrowth.

9. The system of claim 1, wherein the plurality of projections of the anchor assembly are each a sub-annular projections positioned lower than the retention structure when the artificial valve is deployed to mate with the retention structure of the anchor assembly, and the anchor assembly further includes a generally central hub positioned lower than the sub-annular projections and positioned radially inward from the retention structure and the sub-annular projections when the artificial valve is deployed to mate with the retention structure of the anchor assembly.

10. A mitral valve replacement system for a heart having an inflow end and an outflow end, the mitral valve including commissural clefts, an anterior leaflet, a posterior leaflet, an annulus and a sub-annular gutter, comprising:

an anchor assembly configured for placement within the heart, the anchor assembly including a first expandable frame movable between a compressed configuration and an expanded configuration, a retention structure closer to the inflow end than the outflow end and a plurality of sub-annular projections, two of the plurality of sub-annular projections in the expanded configuration being configured to be in contact with the sub-annular gutter proximate the commissural cleft and another two of the plurality of sub-annular projections in the expanded configuration being configured to be in contact with the sub-annular gutter behind the posterior leaflet in the sub-annular gutter, wherein in the expanded configuration each of the plurality of sub-annular projections has one of its two ends attached to a portion of the anchor assembly that is radially inward of and below the retention structure and closer to the outflow end than the inflow end; and

an artificial valve comprising;

a second expandable frame and valve leaflets attached to the second expandable frame, wherein the second expandable frame of the artificial valve is expandable from a collapsed configuration, while the anchor assembly remains in the expanded configuration, to a deployed configuration to selectively contact and mate with the retention structure of the anchor assembly;

wherein the anchor assembly leaves the leaflets of the mitral valve unaffected and the anchor assembly does not interrupt leaflet, chordae, or native valve function of the mitral valve prior to placement of the artificial valve.

11. The system of claim 10, wherein the anchor assembly is sized and shaped to be implanted without reshaping the annulus.

12. The system of claim 10, wherein the artificial valve includes a sealing structure configured to engage natural tissue.

13. The system of claim 10, wherein the first 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 second expandable frame of the artificial valve comprises a second nickel titanium alloy wire construction that is expandable independently from the first expandable frame of the anchoring assembly.

14. The system of claim 10, the anchor assembly further comprising a supra-annular holding structure.

15. The system of claim 14, wherein the supra-annular holding structure comprises at least one of an apron and a visor.

16. The system of claim 10, wherein at least one projection of the plurality of sub-annular projections includes a curved portion.

17. The system of claim 10, further comprising providing a sealing element between the anchor assembly and the artificial valve, wherein the sealing element is configured to promote tissue ingrowth.

18. The system of claim 10, wherein the plurality of sub-annular projections of the anchor assembly are positioned lower than the retention structure in the expanded configuration of the anchor assembly, and the anchor assembly further includes a generally central hub positioned lower than the plurality of sub-annular projections and positioned radially inward from the retention structure and the plurality of sub-annular projections while the anchor assembly is in the expanded configuration.

19. The system of claim 10, wherein the plurality of sub-annular projections consists of four sub-annular projections, wherein first and second sub-annular projections of the four sub-annular projections are positioned lower than the retention structure to anchor sub-annularly proximate the commissural cleft, and wherein third and fourth sub-annular projections of the four sub-annular projections being positioned lower than the retention structure to anchor sub-annularly behind the posterior leaflet in the sub-annular gutter.

20. A mitral valve replacement system for a heart, the mitral valve including commissural clefts, an anterior leaflet, a posterior leaflet, an annulus and a sub-annular gutter, comprising:

an anchor assembly configured for placement within the heart;

an artificial valve configured to contact and mate with a retention structure of the anchor assembly;

the anchor assembly being movable to an anchoring configuration in which the artificial valve is deployed within the anchor assembly, the anchor assembly in the anchoring configuration includes;

the retention structure, a plurality of sub-annular projections positioned lower than the retention structure, and a generally central hub positioned entirely below the retention structure, positioned entirely below the plurality of sub-annular projections, and positioned radially inward from the retention structure and the plurality of sub annular-projections, at least one of the plurality of sub-annular projections being configured to engage with the sub-annular gutter; and

wherein the anchor assembly leaves the leaflets of the mitral valve unaffected and the anchor assembly does not interrupt leaflet, chordae, or native valve function of the mitral valve, while said at least one of the plurality of sub-annular projections is configured to engage with the sub-annular gutter.

21. The system of claim 20, wherein the anchor assembly is sized and shaped to be implanted without reshaping the annulus.

22. The system of claim 20, wherein at least one projection of the plurality of sub-annular projections has a curved portion.

23. The system of claim 20, wherein the anchor assembly is movable between a compressed configuration and an expanded configuration.

24. The system of claim 20, wherein the artificial valve is configured to seal against natural tissue.

25. The system of claim 20, wherein the anchor assembly includes a supra-annular holding structure.

26. The system of claim 25, wherein the supra-annular holding structure comprises at least one of an apron and a visor.

27. The system of claim 20, wherein the artificial valve comprises:

an expandable frame that defines both a circular valve orifice with valve leaflets directly attached thereto and a generally D-shaped outer peripheral region configured for engagement with the retention structure of the anchor assembly, the circular valve orifice being located radially inward from the generally D-shaped outer peripheral region.

28. The system of claim 27, wherein the anchor assembly is movable between a compressed configuration and an expanded configuration, wherein the expandable frame of the artificial valve is expandable from a collapsed configuration, while the anchor assembly remains in the expanded configuration, to a deployed configuration to selectively engage with the retention structure of the anchor assembly.