Prosthetic valve for replacing mitral valve

• US 10,507,102 B2
• Filed: 04/05/2018
• Issued: 12/17/2019
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Yi, Seung-Beom, Geist, Stephen C., Oba, Travis Zenyo
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/945,878
• Publication Number:
  US 20180263767A1
• Time in Patent Office: 621 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 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
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A prosthetic apparatus for implantation in a native mitral valve includes a main body for placement within the native mitral annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. An atrial sealing member is disposed along an atrial portion of the main body and ventricular anchors are coupled to a ventricular portion of the main body. The atrial sealing member impedes the flow of blood between the main body and the native annulus. The ventricular anchors are positioned outside the main body for capturing native mitral valve leaflets between the main body and the ventricular anchors.

Claims

1. A method of reducing regurgitation of the native mitral valve of a heart, the native mitral valve having a native annulus, posterior and anterior native valve leaflets, wherein the native leaflets define a regurgitant orifice area therebetween that allows blood to flow from the left ventricle to the left atrium during ventricular systole, the method comprising:

delivering a prosthetic apparatus in a compressed state through the patient'"'"'s vasculature to the heart;

expanding the prosthetic apparatus from the compressed state to an expanded state;

positioning a spacer body of the prosthetic apparatus between the native leaflets;

positioning a lower anchor of the prosthetic apparatus on an inferior side of the anterior native valve leaflet;

positioning a second lower anchor of the prosthetic apparatus on an inferior side of the posterior native valve leaflet;

positioning a first upper anchor of the prosthetic apparatus on a superior side of the anterior native valve leaflet; and

positioning a second upper anchor of the prosthetic apparatus on a superior side of the posterior native valve leaflet;

wherein the spacer body occupies space within the regurgitant orifice area to reduce regugitation through the native mitral valve during ventricular systole.

2. The method of claim 1, wherein the first and second lower anchors are configured to retain the posterior and anterior native valve leaflets against an outer surface of the spacer body.

3. The method of claim 1, wherein the first and second lower anchors comprise a shape memory material.

4. The method of claim 1, wherein the spacer body comprises a shape memory material.

5. The method of claim 1, wherein the first and second lower anchors are on diametrically opposed sides of the spacer body.

6. The method of claim 1, wherein:

positioning the first lower anchor comprises positioning the first lower anchor at an A2 region of the anterior native valve leaflet;

positioning the second lower anchor comprises positioning the second lower anchor at a P2 region of the posterior native valve leaflet.

7. The method of claim 1, wherein the act of delivering the prosthetic apparatus includes advancing the prosthetic apparatus through an atrial portion of the patient'"'"'s septum separating the left and right atria.

8. The method of claim 1, wherein the spacer body comprises an atrial end and a ventricular end, and the first and second lower anchors extend from the ventricular end toward the atrial end of the spacer body.

9. The method of claim 8, wherein each of the first and second lower anchors comprises an elongate member having a fixed end portion secured to the ventricular end of the spacer body and a free end portion disposed toward the atrial end of the spacer body.

10. The method of claim 1, wherein each of the first and second lower anchors comprises an elongate member having a first and second fixed end portions secured to a ventricular end of the prosthetic apparatus, first and second intermediate portions extending from the fixed end portions, and a bent portion disposed between the first and second intermediate portions.

11. The method of claim 1, wherein the spacer body is shaped to reduce central jet regurgitation through the native mitral valve leaflets during ventricular systole.

12. The method of claim 1, wherein the spacer body is shaped to reduce eccentric jet regurgitation through the native mitral valve leaflets during ventricular systole.

13. The method of claim 1, wherein when the prosthetic apparatus is implanted within the native mitral valve, the antero-lateral margins and the postero-lateral margins of the native leaflets can coapt with each other during ventricular systole.

14. A method of reducing regurgitation of the native mitral valve having anterior and posterior native valve leaflets defining a regurgitant orifice area therebetween that allows blood to flow from the left ventricle to the left atrium during ventricular systole, the method comprising:

delivering a prosthetic spacer in a compressed state through the patient'"'"'s vasculature to the native mitral valve region;

radially expanding the prosthetic spacer from the compressed state to an expanded state;

positioning a blood-impermeable spacer body of the prosthetic spacer within the regurgitant orifice area between the anterior and posterior native valve leaflets, the spacer body reducing regurgitant blood flow during ventricular systole;

positioning a first ventricular anchor of the prosthetic spacer behind the posterior native valve leaflet; and

positioning a second ventricular anchor of the prosthetic spacer behind the anterior native valve leaflet,

wherein the first and second ventricular anchors retain portions of the native valve leaflets against the spacer body.

15. The method of claim 14, wherein positioning the first ventricular anchor comprises positioning the first ventricular anchor at the A2 region of the anterior native valve leaflet, and positioning the second ventricular anchor comprises positioning the second ventricular anchor at the P2 region of the posterior native valve leaflet.

16. The method of claim 14, wherein prior to positioning the first and second ventricular anchors behind the native valve leaflets, the first and second ventricular anchors are expanded radially outwardly from the spacer body.

17. The method of claim 14, wherein the first and second ventricular anchors are coupled to a ventricular end portion of the spacer body and extend in an atrial direction to locations behind respective native valve leaflets.

18. The method of claim 14, wherein portions the first and second ventricular anchors extend axially beyond a ventricular end of the spacer body.

19. A method of ireducing regurgitation of the native mitral valve having native valve leaflets defining a regurgitant orifice area therebetween, the method comprising:

delivering the prosthetic spacer in an axially-elongate, radially-compressed state through the patient'"'"'s vasculature to the native mitral valve region, wherein the prosthetic spacer includes a spacer body and a plurality of anchors coupled to the spacer body;

moving the prosthetic spacer from the axially-elongate, radially-compressed state to an axially-foreshortened, radially-expanded state;

positioning the anchors of the prosthetic device in a left ventricle of the heart; and

moving the prosthetic device atrially relative to the native mitral valve such that the anchors are disposed behind the native valve leaflets and the spacer body is disposed within the regurgitant orifice area between the native valve leaflets,

wherein the spacer body is shaped to reduce regurgitant blood flow through the native mitral valve during ventricular systole.

20. The method of claim 19, wherein the anchors comprise fixed end portions coupled to the ventricular end portion of the spacer body, and engagement portions that extend circumferentially and are configured to contact the native valve leaflets.

21. The method of claim 19, wherein the spacer body is sized such that the antero-lateral margins and the postero-lateral margins of the native valve leaflets can coapt with each other during ventricular systole.

22. The method of claim 19, wherein in the axially-elongate, radially-compressed state, the anchors extend axially away from a ventricular end portion of the spacer body, and wherein in the axially-foreshortened, radially-expanded stated, the anchors extend axially toward an atrial end portion of the spacer body and overlap radially with the spacer body.