METHODS AND SYSTEMS FOR HEART VALVE THERAPY

• US 20150112433A1
• Filed: 05/02/2014
• Published: 04/23/2015
• 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.
• Granted Patent: US 9,421,094 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 at least one of the plurality of projections is placed into engagement with the sub-annular gutter; and

an artificial valve comprising an expandable frame having a generally D-shaped outer peripheral region configured for engagement with 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 that define a circular perimeter at 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 engage with the retention structure of the anchor assembly;

wherein the anchor assembly permits maintenance of natural function of anterior and posterior leaflets of the mitral valve while the anchor assembly is in the expanded configuration prior to placement of the artificial valve.

2. The system of claim 1, wherein the anchoring 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 anchoring assembly is movable between a compressed configuration and an expanded configuration.

5. The system of claim 1, wherein the artificial valve seals against natural tissue.

6. The system of claim 1, wherein the anchor assembly includes an atrial holding structure.

7. 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.

24. The system of claim 1, wherein the plurality of projections of the anchor assembly are sub-annular projections positioned lower than the retention structure, 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.

25. The system of claim 6, wherein the atrial holding structure comprises at least one of an apron and visor.

8. 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 first expandable frame movable between a compressed configuration and an expanded configuration, a retention structure and a plurality of sub-annular projections, two of the plurality of sub-annular projections being configured to be placed sub-annularly proximate the commissural cleft and two being configured to be placed sub-annularly behind the posterior leaflet in the sub-annular gutter; 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 engage with the retention structure of the anchor assembly;

wherein the anchor assembly permits maintenance of natural function of anterior and posterior leaflets of the mitral valve while the first expandable frame of the anchor assembly is in the expanded configuration prior to placement of the artificial valve.

9. The system of claim 8, wherein the anchoring assembly is sized and shaped to be implanted without reshaping the annulus.

10. The system of claim 8, wherein the artificial valve includes a sealing structure configured to engage natural tissue.

11. The system of claim 8, wherein the first expandable frame of the anchor assembly comprises a first nitinol wire construction that is movable between the compressed configuration and the expanded configuration, and wherein the second expandable frame of artificial valve comprises a second nitinol wire construction that is expandable independently from the first expandable frame of the anchoring assembly.

12. The system of claim 8, the anchor assembly further comprising an atrial holding structure.

13. The system of claim 8, wherein at least one projection for the sub-annular projections includes a curved portion.

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

26. The system of claim 8, wherein the plurality of sub-annular projections of the anchor assembly are positioned lower than 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.

27. The system of claim 12, wherein the atrial holding structure comprises at least one of an apron and visor.

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

an artificial valve configured for engagement with the retention structure of the anchor assembly;

wherein the anchor assembly permits maintenance of natural function of anterior and posterior leaflets of the mitral valve while said at least one of the sub-annular projections engages with the sub-annular gutter.

16. The system of claim 15, wherein the anchoring assembly is sized and shaped to be implanted without reshaping the annulus.

17. The system of claim 15, wherein at least one projection of the sub-annular projections has a curved position.

18. The system of claim 15, wherein the anchoring assembly is movable between a compressed configuration and an expanded configuration.

19. The system of claim 15, wherein the artificial valve is configured to seal against natural tissue.

20. The system of claim 15, wherein the anchor assembly included an atrial holding structure.

21. The system of claim 20, wherein the atrial holding structure comprises at least one of an apron and visor.

22. The system of claim 15, wherein the artificial valve comprises:

an expandable frame having a generally D-shaped outer peripheral region configured for engagement with 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 that define a circular perimeter at the circular valve orifice.

23. The system of claim 22, wherein the anchor assembly is movable between a compressed configuration and an expanded configuration in which said at least one of the sub-annular projections is positioned to engage with the sub-annular gutter, and 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.