Mitral valve prosthesis

• US 10,583,009 B2
• Filed: 10/04/2019
• Issued: 03/10/2020
• Est. Priority Date: 06/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hauser, David L., Solem, Jan Otto, Alon, David
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US16/593,360
• Publication Number:
  US 20200030084A1
• Time in Patent Office: 158 Days
• 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 2/2436 Deployment by retracting a sheath
• 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 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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

Abstract

A method of treating a defective mitral valve includes percutaneously advancing a prosthetic device into a patient'"'"'s heart. The prosthetic device includes an insert member and anchoring member. The prosthetic device is contained within a sheath along a distal end of a delivery catheter during advancement. The anchoring member is secured to a muscular wall of the left ventricle and the insert member self-expands between native leaflets of the mitral valve. The insert member preferably includes a biocompatible fabric outer layer, a passageway, and a valve member disposed within the passageway. After deployment, the native leaflets of the mitral valve form a tight seal against the fabric outer layer of the insert member for preventing regurgitation, while blood passes through the passageway of the insert member for allowing blood to pass from the left atrium to the left ventricle.

Claims

1. A method of treating a defective mitral valve, comprising:

inserting a delivery catheter through a small incision in a patient'"'"'s groin, the delivery catheter having a prosthetic device contained within a sheath along a distal end of the delivery catheter, the prosthetic device comprising an insert member and anchoring member;

advancing the distal end of the delivery catheter through a patient'"'"'s vasculature and into a left ventricle;

securing the anchoring member to a muscular wall of the left ventricle; and

allowing the insert member to self-expand between native leaflets of a mitral valve, the insert member including a biocompatible fabric outer layer, a passageway extending therethrough along a longitudinal axis extending from a left atrium to the left ventricle, and a valve member disposed within the passageway, the valve member including one or more flap members defining a one-way valve;

wherein, after deployment of the prosthetic device, the native leaflets of the mitral valve form a tight seal against the fabric outer layer of the insert member for preventing regurgitation, while blood passes through the passageway of the insert member for allowing blood to pass from the left atrium to the left ventricle.

2. The method of claim 1, wherein the insert member has a cross-sectional profile shaped for allowing the native leaflets of the mitral valve to create a tight seal against the fabric outer layer of the insert member.

3. The method of claim 2, wherein the insert member has a crescent-shape cross-sectional profile.

4. The method of claim 1, wherein the anchoring member includes hooks for securing the anchoring member to the muscular wall.

5. The method of claim 1, wherein the anchoring member comprises an engagement member in the form of elongated prongs for securing the anchoring member to the muscular wall.

6. The method of claim 5, wherein the elongated prongs self-expand to form a flower-shape in the expanded configuration.

7. The method of claim 6, wherein the elongated prongs self-expand radially outward and rearward for engagement with tissue of the muscular wall.

8. The method of claim 7, wherein the elongated prongs further comprise barbs.

9. The method of claim 5, wherein the elongated prongs are treated to promote tissue ingrowth.

10. The method of claim 1, wherein at least one plate is coupled to the anchoring member for securing the anchoring member to the muscular wall.

11. The method of claim 1, wherein the insert member comprises metal surrounded by the biocompatible fabric outer layer.

12. The method of claim 1, wherein the insert member exhibits sufficient rigidity to substantially maintain a deployed shape within the mitral valve after deployment and is flexible enough to be compressed to a reduced diameter for containment within the sheath.

13. The method of claim 1, wherein the anchoring member comprises a shaft.

14. The method of claim 1, wherein the anchoring member comprises an elongate body portion.

15. The method of claim 1, wherein the delivery catheter has a length of at least 80 cm for percutaneous advancement through the patient'"'"'s vasculature.

16. The method of claim 1, wherein the delivery catheter is steerable.

17. A method of treating a defective mitral valve, comprising:

inserting a delivery catheter through a small incision in a patient'"'"'s groin, the delivery catheter having a prosthetic device contained within a sheath along a distal end of the delivery catheter, the prosthetic device comprising an insert member and anchoring member formed with a plurality of elongated prongs;

advancing the distal end of the delivery catheter through a patient'"'"'s vasculature and into a left ventricle;

allowing the elongated prongs to self-expand within a muscular wall of the left ventricle for securing the anchoring member to the left ventricle; and

allowing the insert member to self-expand between native leaflets of a mitral valve, the insert member including a biocompatible fabric outer layer, a passageway extending therethrough along a longitudinal axis extending from a left atrium to the left ventricle, and a valve member disposed within the passageway, the valve member including one or more flap members defining a one-way valve;

wherein, after deployment of the prosthetic device, the native leaflets of the mitral valve form a tight seal against the fabric outer layer of the insert member for preventing regurgitation, while blood passes through the passageway of the insert member for allowing blood to pass from the left atrium to the left ventricle.

18. The method of claim 17, wherein the insert member has a cross-sectional profile shaped for allowing the native leaflets of the mitral valve to create a tight seal against the fabric outer layer of the insert member.

19. The method of claim 18, wherein the insert member has a crescent-shape cross-sectional profile.

20. The method of claim 17, wherein the delivery catheter is steerable.