Transcatheter mitral valve

• US 9,968,445 B2
• Filed: 06/13/2014
• Issued: 05/15/2018
• Est. Priority Date: 06/14/2013
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Kheradvar, Arash
• Primary Examiner(s): Prebilic, Paul
• Application Number:
  US14/898,048
• Publication Number:
  US 20160143730A1
• Time in Patent Office: 1,432 Days
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• 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 2230/0095 Saddle-shaped

Abstract

Described is a transcatheter mitral valve. The mitral valve includes a saddle-shaped annulus frame with two prongs extending therefrom. Two leaflets are attached with the frame and prongs to form a bi-leaflet mitral valve. The frame is collapsible to a collapsed configuration that allows for delivery and implantation at a mitral position. When at the mitral position, the mitral valve expands into an open configuration and is secured in place by a fixture, such as clamps that extend from the frame.

Claims

1. A transcatheter mitral valve comprising:

a wire annulus frame, having two prongs extending therefrom;

two leaflets attached with the frame and prongs to form a bi-leaflet mitral valve;

a fixture formed in the wire annulus frame to include one or more clamps; and

wherein the wire annulus frame is a saddle-shaped annulus frame having an annulus rise reflecting curvature of the saddle-shaped annulus frame, the annulus rise having an apex, with the each of the one or more clamps being wire clamps projecting from the saddle-shaped annulus frame directly beneath the apex, whereby when the transcatheter mitral valve is implanted in a patient, a native mitral annulus is affixed between the apex and the one or more clamps.

2. The transcatheter mitral valve as set forth in claim 1, wherein the frame and prongs are formed of a shape memory material.

3. The transcatheter mitral valve as set forth in claim 2, wherein the shape memory material is Nitinol.

4. The transcatheter mitral valve as set forth in claim 3, wherein the saddle-shaped annulus frame is configurable between a collapsed configuration and an open configuration, such the collapsed configuration allows the transcatheter mitral valve to be delivered into position against a native mitral valve annulus and upon expanding to the open configuration, the transcatheter mitral valve is secured in place by the fixture.

5. The transcatheter mitral valve as set forth in claim 4, wherein the prongs have a prong length, the prong length being between 5 millimeters and 30 millimeters.

6. The transcatheter mitral valve as set forth in claim 5, wherein the prongs each include a prong axis and extend from the saddle-shaped annulus frame at an intersection, such that a prong angle exists between the prong axis and a vertical axis rising vertically from the intersection, where the prong angle is between 5 degrees and 40 degrees.

7. The transcatheter mitral valve as set forth in claim 6, wherein the leaflets are formed of a material selected from a group consisting of pericardial tissue, polymeric material, and leaflet tissue material.

8. The transcatheter mitral valve as set forth in claim 1, wherein the saddle-shaped annulus frame is configurable between a collapsed configuration and an open configuration, such the collapsed configuration allows the transcatheter mitral valve to be delivered into position against a native mitral valve annulus and upon expanding to the open configuration, the transcatheter mitral valve is secured in place by the fixture.

9. The transcatheter mitral valve as set forth in claim 1, wherein the leaflets are formed of a material selected from a group consisting of pericardial tissue, polymeric material, and leaflet tissue material.

10. The transcatheter mitral valve as set forth in claim 1, wherein the annulus rise is between 2 millimeters and 5 millimeters.

11. The transcatheter mitral valve as set forth in claim 1, wherein the prongs have a prong length, the prong length being between 5 millimeters and 30 millimeters.

12. The transcatheter mitral valve as set forth in claim 1, wherein the prongs each include a prong axis and extend from the frame at an intersection, such that a prong angle exists between the prong axis and a vertical axis rising vertically from the intersection, where the prong angle is between 5 degrees and 40 degrees.

13. The transcatheter mitral valve as set forth in claim 1, wherein the wire annulus frame is enclosed in fabric.