Apparatus and methods for treating cardiac valve regurgitation

• US 9,629,720 B2
• Filed: 05/04/2015
• Issued: 04/25/2017
• Est. Priority Date: 05/04/2015
• Status: Active Grant

• Current Assignee: Jacques Seguin
• Original Assignee: Jacques Seguin
• Inventors: Seguin, Jacques, Nguyen, Than
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/703,775
• Publication Number:
  US 20160324639A1
• Time in Patent Office: 722 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 2/2412 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

Apparatus and methods for repairing a cardiac valve, e.g., a mitral valve, are provided. The apparatus may include an expandable frame defining a curved structure in the expanded deployed state and a membrane coupled to the expandable frame. The membrane may curve around a native leaflet, e.g., the posterior leaflet, in a first plane and curve around another leaflet, e.g., the anterior leaflet, in an orthogonal plane. The membrane may be adapted to be suspended in the flow path of the cardiac valve such a first surface of the membrane abuts the native leaflet during systole and a second surface of the membrane abuts the other native leaflet during systole, thereby reducing cardiac valve regurgitation.

Claims

1. A prosthetic device for repairing a cardiac valve defining a flow path bounded by a first native leaflet and a second native leaflet, the prosthetic device comprising:

an expandable frame configured to transition from a contracted delivery state to an expanded deployed state, the expandable frame defining a saddle-shaped structure in the expanded deployed state, wherein the saddle-shaped structure has a long axis configured to extend through the cardiac valve so that an upper portion is disposed in a first heart chamber and a first lower portion is disposed in a second heart chamber, and a short axis, shorter than the long axis, the saddle-shaped structure having a curvature configured to conform to an annulus of the cardiac valve, the expandable frame having one or more attachment portions configured to secure the prosthetic device to cardiac tissue in the expanded deployed state; and

a membrane coupled to the expandable frame and adopting the saddle-shape when the expandable frame is in the expanded deployed state, the membrane defining a first surface and a second surface, the membrane configured to be suspended in the flow path so that the first surface is configured to abut the first native leaflet during systole but not during diastole and the second surface is configured to abut the second native leaflet during systole but not during diastole, to thereby reduce cardiac valve regurgitation.

2. The prosthetic device of claim 1, wherein the expandable frame further comprises a second lower portion that is configured to curve toward the second native leaflet.

3. The prosthetic device of claim 2, wherein the membrane is not coupled to at least part of the second lower portion to define an exposed portion configured to reduce or eliminate contact between the second lower portion and native chordae tendineae.

4. The prosthetic device of claim 2, wherein the first lower portion and the second lower portion each comprise a peak.

5. The prosthetic device of claim 1, wherein the membrane is coupled to the saddle-shaped structure along an entire perimeter of the membrane.

6. The prosthetic device of claim 1, wherein a convex portion of the first surface at a plane of the cardiac valve is sized and shaped to mimic a curve of the first native leaflet.

7. The prosthetic device of claim 1, wherein a concave portion of the second surface at a plane of the cardiac valve is sized and shaped to mimic a curve of the second native leaflet.

8. The prosthetic device of claim 1, wherein the expandable frame having the membrane coupled thereto is configured to be contracted to the contracted delivery state for loading and delivery with a delivery catheter.

9. The prosthetic device of claim 1, wherein the one or more attachment portions comprise first and second curved portions configured to engage opposing portions of the annulus of the cardiac valve.

10. The prosthetic device of claim 1, wherein the one or more attachment portions are configured to be secured to cardiac tissue via one or more fixation devices.

11. The prosthetic device of claim 1, wherein the expandable frame is configured to accommodate deployment of a replacement valve, such that the expandable frame serves as an anchor for the replacement valve.

12. The prosthetic device of claim 1, wherein the upper portion of the saddle-shaped structure curves around the first native leaflet for 4 to 17 mm.

13. The prosthetic device of claim 1, wherein the expandable frame further comprises one or more strain relief members configured to permit deflection of the expandable frame to reduce strain during compression of the heart.

14. The prosthetic device of claim 1, wherein the prosthetic device is configured to be deployed at the mitral valve.

15. The prosthetic device of claim 1, wherein the membrane comprises an upper portion and a lower portion, the upper portion of the membrane coupled to the upper portion of the expandable frame and disposed in the first heart chamber in the expanded deployed state, the lower portion of the membrane coupled to the first lower portion of the expandable frame and disposed in the second heart chamber in the expanded deployed state, the upper and lower portions of the membrane configured to curve around the first native leaflet without touching the first native leaflet or annulus.