Valve replacement systems and methods

• US 9,427,316 B2
• Filed: 05/01/2014
• Issued: 08/30/2016
• Est. Priority Date: 04/19/2012
• 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): LOUIS, RICHARD G
• Application Number:
  US14/267,105
• Publication Number:
  US 20140236291A1
• Time in Patent Office: 852 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 623/2.17, 623/2.18
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• 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 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

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

Claims

1. A mitral valve replacement system configured to be implanted in multiple stages to treat a heart having a mitral valve including commissural clefts, at least a posterior leaflet and an anterior leaflet to provide a mitral valve leaflet function of occluding flow during systole and opening flow during diastole, and an annulus, comprising:

an anchoring structure including a supra-annular retention structure and anchoring elements that are configured to engage sub-annular structure of the mitral valve to position the anchoring structure relative to the mitral valve without significantly interrupting the mitral valve leaflet function of occluding flow during systole and opening flow during diastole; and

an artificial valve configured to be received by the supra-annular retention anchoring structure after the anchoring structure is placed separately within the heart;

wherein the artificial valve is sized and shaped such that an upper portion of the artificial valve mates with the supra-annular retention structure at a position spaced supra-annularly of the mitral valve annulus while a lower portion of the artificial valve extends to a position sub-annularly of the mitral valve annulus, wherein the anchoring elements of the anchoring structure comprise a plurality of wire loop projections configured to pass through a commissural cleft and the engage sub-annular structure.

2. The mitral valve replacement system of claim 1, wherein the anchoring structure is sized and shaped to be implanted at a mitral valve annulus without reshaping the annulus.

3. The mitral valve replacement system of claim 1, the anchoring structure further comprising a projection configured to engage the mitral valve annulus along a posterior leaflet.

4. The mitral valve replacement system of claim 1, the anchoring structure further comprising annulus engaging structures having shapes configured to mimic contours of the annulus of the mitral valve.

5. The mitral valve replacement system of claim 1, wherein the anchoring structure is movable between a compressed configuration and an expanded configuration.

6. The mitral valve replacement system of claim 1, wherein the anchoring structure is configured for tissue ingrowth.

7. The mitral valve replacement system of claim 1, the anchoring structure further comprising projections configured to engage a mitral valve trigone.

8. A mitral valve replacement system configured to be implanted in multiple stages to treat a heart having a mitral valve including commissural clefts, at least a posterior leaflet and an anterior leaflet to provide a mitral valve leaflet function of occluding flow during systole and opening flow during diastole, and an annulus, comprising:

an anchoring structure including a supra-annular ring-like structure and anchoring elements that are configured to engage sub-annular structure of the mitral valve to position the anchoring structure relative to the mitral valve without significantly interrupting the mitral valve leaflet function of occluding flow during systole and opening flow during diastole; and

an artificial valve configured to be received by with the supra-annular ring-like anchoring structure after the anchoring structure is placed separately within the heart;

wherein the artificial valve is sized and shaped such that an upper portion of the artificial valve mates with the supra-annular ring-like structure and remains spaced supra-annularly of the mitral valve annulus while a lower portion of the artificial valve extends to a position sub-annularly of the mitral valve annulus, wherein the anchoring elements of the anchoring structure comprise a plurality of wire loop projections configured to pass through a commissural cleft and the engage sub-annular structure.

9. The mitral valve replacement system of claim 8, wherein the anchoring structure is sized and shaped to be implanted at a mitral valve annulus without reshaping the annulus.

10. The mitral valve replacement system of claim 8, the anchoring structure further comprising a projection configured to engage the mitral valve annulus along a posterior leaflet.

11. The mitral valve replacement system of claim 8, wherein the anchoring structure has a curved portion.

12. The mitral valve replacement system of claim 8, wherein the anchoring structure is movable between a compressed configuration and an expanded configuration.

13. A mitral valve replacement system configured to be implanted in multiple stages to treat a heart having a mitral valve including commissural clefts, at least a posterior leaflet and an anterior leaflet to provide a mitral valve leaflet function of occluding flow during systole and opening flow during diastole, and an annulus, comprising:

an anchoring structure including a supra-annular retention structure and anchoring elements that extend below the supra-annular retention structure and are configured to engage sub-annular structure of the mitral valve to position the anchoring structure relative to the mitral valve without significantly interrupting the mitral valve leaflet function of occluding flow during systole and opening flow during diastole; and

an artificial valve configured to sealingly engage with natural tissue and to be received by the supra-annular retention anchoring structure after the anchoring structure is placed separately within the heart;

wherein the artificial valve is sized and shaped such that an upper portion of the artificial valve mates with the supra-annular retention structure at a position spaced supra-annularly of the mitral valve annulus while a lower portion of the artificial valve extends to a position sub-annularly of the mitral valve annulus, wherein the anchoring elements of the anchoring structure comprise a plurality of wire loop projections configured to pass through a commissural cleft and the engage sub-annular structure.

14. The mitral valve replacement system of claim 13, wherein the anchoring structure is sized and shaped to be implanted at a mitral valve annulus without reshaping the annulus.

15. The mitral valve replacement system of claim 13, the anchoring structure further comprising a projection configured to engage the mitral valve annulus along a posterior leaflet.

16. The mitral valve replacement system of claim 13, wherein the seal is created by sealing against a native leaflet.

17. The mitral valve replacement system of claim 16, wherein the seal is created without reshaping the annulus.