A prosthetic spacer for implanting at the native mitral valve region

A prosthetic spacer with a radially compressible body and one-way valve enhances integration and functionality of prosthetic valves in the mitral valve region, addressing integration issues and improving performance.

HK40135023APending Publication Date: 2026-07-17EDWARDS LIFESCIENCES CORP
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Patent Information

Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
EDWARDS LIFESCIENCES CORP
Filing Date
2026-05-15
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing prosthetic valves for the mitral valve region often fail to effectively integrate with the natural mitral valve, leading to suboptimal performance and potential complications.

Method used

A prosthetic spacer with a radially compressible body and a one-way valve portion, along with a ventricular anchor and atrial seal, is designed to facilitate secure implantation within the natural mitral valve, enhancing integration and functionality.

Benefits of technology

The solution provides improved integration and functionality of the prosthetic valve within the mitral valve region, reducing complications and enhancing performance.

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Abstract

Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described.
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Description

Invention Title: Prosthetic Spacer for Implantation in Natural Mitral Valve Region Abstract: Embodiments of an artificial valve for implantation within a natural mitral valve are provided. A preferred embodiment of the artificial valve includes a radially compressible body and a one-way valve portion. The artificial valve further includes at least one ventricular anchor connected to and located outside the body. A space is provided between the outer surface of the body and the ventricular anchor for receiving a natural mitral valve leaflet. The artificial valve preferably includes an atrial seal adapted for placement on the mitral valve annulus. Methods and apparatus for delivering and implanting the artificial valve are also described. Abstract

Claims

1. A frame for use in a prosthetic heart valve, the frame comprising ventricular anchors; wherein each ventricular anchor comprises a wire or similar element that extends from one or two attachment points on a main body of the frame; wherein the ventricular anchors are pre-formed to extend along an outer side of the main body in a functional, deployed state; wherein, during delivery, the ventricular anchors are partially or completely straightened and retained in that state by a delivery device, such as a sheath; wherein, as the frame is advanced from the sheath, the ventricular anchors spring back to their pre-formed state.

2. The frame of claim 1, further comprising an atrial sealing member.

3. The frame of any one of the preceding claims, wherein the ventricular anchors are pre-formed in a curved shape that extends along the side of the main body in the deployed state.

4. The frame of any one of the preceding claims, wherein the ventricular anchors elastically deflect upward or bend around respective leaflets when the ventricular anchors are freed from the sheath.

5. The frame of any one of the preceding claims, wherein the frame is made of a wire mesh and is radially collapsible and expandable between a radially expanded state and a radially compressed state to enable delivery and implantation at the mitral valve region of the heart or within another native heart valve.

6. The frame of claim 5, wherein the frame comprises a shape-memory material, such as Nitinol, to enable self-expansion from the radially compressed state to the expanded state.

7. The frame of any one of claims 5 or 6, wherein the main body forms an open-ended tube in the expanded state.

8. The frame of any one of claims 5 to 7, wherein an outer surface of the main body has dimensions similar to that of the mitral orifice.

9. The frame of any one of the preceding claims, wherein the main body comprises at least one extension member that extends downward from a ventricular end of the main body.

10. The frame of any one of the preceding claims, comprising exactly two ventricular anchors.

11. The frame of any one of the preceding claims, wherein the ventricular anchors each comprise a necked mid portion and a broad upper portion.

12. The frame of claim 11, wherein the broad upper portion has a curvature that corresponds to the curvature of the outer surface of the main body.

13. A prosthetic heart valve comprising the frame of any one of the preceding claims.

14. The prosthetic heart valve of claim 13, wherein the prosthetic heart valve is primarily intended to be implanted at the mitral valve region.

15. The prosthetic heart valve of any one of claims 13 or 14, wherein the prosthetic heart valve is configured for implantation in a heart valve other than the mitral valve.