PROSTHETIC APPARATUS FOR IMPLANTATION AT MITRAL VALVE

• US 20120323316A1
• Filed: 08/28/2012
• Published: 12/20/2012
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Yi, Seung, Geist, Steve, Oba, Travis, Patterson, Marlowe E.
• Granted Patent: US 8,585,755 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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

Embodiments of prosthetics configured for implanting in at the native mitral valve region of the heart include a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Methods and apparatus for delivering and implanting the prosthetic valve are also described.

Claims

1. A prosthetic apparatus for implanting at the native mitral valve region of the heart, the native mitral valve having a native annulus and native valve leaflets, the leaflets comprising a free edge portion and an annulus connection portion, the prosthetic apparatus comprising:

a main body configured for placement within the native mitral valve, the main body being compressible to a compressed state for delivery into the heart and expandable from the compressed state to an expanded state;

at least one ventricular anchor coupled to and disposed outside of the main body such that, in the expanded state, a leaflet-receiving space exists between the ventricular anchor and an outer surface of the main body to receive a free edge portion of a native valve leaflet, the ventricular anchor comprising an engagement portion configured to extend behind the received native leaflet and engage a ventricular surface of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the ventricular surface of the native annulus and the annulus connection portion of the received native leaflet, while the free edge portion of the received native leaflet is not engaged by the ventricular anchor; and

at least one atrial anchor coupled to and disposed outside of the main body, the at least one atrial anchor being configured to engage an atrial portion of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the atrial surface of the native annulus and the annulus connection portion of the received native leaflet, at a location opposite the engagement portion of the ventricular anchor for retention of the prosthetic apparatus.

2. The prosthetic apparatus of claim 1, further comprising a valve portion coupled within the main body, the valve portion comprising valve leaflets that form a one-way valve within the main body.

3. The prosthetic apparatus of claim 1, wherein the ventricular anchor is configured to extend behind native chordae tendinae such that the engagement portion contacts the ventricular surface of the native mitral annulus at a commissure region between the native leaflets.

4. The prosthetic apparatus of claim 3, further comprising a second, diametrically opposed ventricular anchor having a second engagement portion, the ventricular anchors being configured such that the prosthetic apparatus can be rotated about a longitudinal axis to position the engagement portions of the anchors at opposing commis sure regions of the native mitral annulus.

5. The prosthetic apparatus of claim 3, further comprising a second ventricular anchor having a second engagement portion, the anchors being positioned adjacent to one another on the same side of the prosthetic apparatus, the ventricular anchors being deflectable to a constrained position wherein the anchors overlap one another and the ventricular anchors being releasable from the constrained position such that the anchors resiliently move apart and the engagement portions of the anchors move in opposite directions to opposite commissure regions of the native mitral annulus.

6. The prosthetic apparatus of claim 1, wherein the main body comprises a crescent shape in the expanded state.

8. The prosthetic apparatus of claim 1, wherein the main body does not allow blood to flow through the main body.

9. The prosthetic apparatus of claim 1, wherein the at least one ventricular anchor comprises an anterior ventricular anchor configured to extend behind the anterior native valve leaflet and a posterior ventricular anchor configured to extend behind the posterior native valve leaflet, such that the free end portions of the anterior and posterior native valve leaflets close around the main body during systole to block blood from flowing toward the left atrium and separate from the main body during diastole to allow blood to flow toward the left ventricle.

7. The prosthetic apparatus of claim 7, wherein the main body comprises a concave anterior side and a convex posterior side when the main body is in the radially expanded state.

10. A method of implanting a prosthetic apparatus at the native mitral valve region of the heart, the native mitral valve having a native annulus and native valve leaflets, the method comprising:

positioning a main body of the prosthetic apparatus in a radially compressed state within the native annulus;

deploying at least one ventricular anchor such that an engagement portion of the ventricular anchor is positioned behind one of the native valve leaflets and contacts a ventricular surface of the native annulus;

allowing the main body to expand from the radially compressed state to a radially expanded state within the native annulus; and

deploying at least one atrial anchor such that an engagement portion of the atrial anchor contacts an atrial surface of the native annulus, the engagement portions of the atrial anchor and the ventricular anchor contacting the native annulus at locations on opposite sides of the native annulus;

wherein the native valve leaflets are free to seal around the main body during systole to prevent blood from flowing toward the left atrium, and wherein the native valve leaflets are free to separate from the main body during diastole to allow blood to flow around the main body into the left ventricle.

11. The method of claim 10, wherein deploying the at least one ventricular anchor comprises retracting a delivery sheath from around the ventricular anchor to allow the ventricular anchor to resiliently move from a delivery position, in which the ventricular anchor extends from the main body in a ventricular direction, to a deployed position, in which the anchor extends from the main body in an atrial direction behind the native valve leaflet.

12. The method of claim 10, wherein deploying at least one ventricular anchor comprises deploying an anterior ventricular anchor such that an engagement portion of the anterior ventricular anchor is positioned behind the anterior native valve leaflet, and deploying a posterior ventricular anchor such that an engagement portion of the posterior ventricular anchor is positioned behind the posterior native valve leaflet.

13. The method of claim 10, wherein the main body comprises a crescent shaped body having a concave anterior side and a convex posterior side when the main body is in the radially expanded state.

14. The method of claim 13, wherein positioning the main body within the native annulus comprises positioning the concave anterior side of the main body facing the anterior native valve leaflet and positioning the convex posterior side of the main body facing the posterior native valve leaflet, such that the native valve leaflets can seal around the main body during systole to prevent mitral regurgitation.

15. The method of claim 14, wherein the main body comprises a prosthetic valve.

16. The method of claim 10, wherein the native valve leaflet between the ventricular anchor and the main body has a free edge extending from one commis sure of the native mitral valve to the other commissure of the native mitral valve, and wherein the entire free edge is allowed to separate from the main body during diastole and then seal around the main body during systole.