Intervalvular implant for a mitral valve

• US 10,639,154 B2
• Filed: 10/12/2015
• Issued: 05/05/2020
• Est. Priority Date: 10/16/2014
• Status: Active Grant

• Current Assignee: Jacques Seguin
• Original Assignee: Jacques Seguin
• Inventors: Seguin, Jacques
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/519,078
• Publication Number:
  US 20170224477A1
• Time in Patent Office: 1,667 Days
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An intervalvular implant for a mitral valve having a frame and a membrane covering the frame is provided. The frame includes an elongated base portion formed by two curved or chevron branches connected to two connection areas of the implant for connecting to the annulus of the mitral valve. The frame further includes a longitudinal hoop extending in a plane substantially perpendicular to the plane in which the elongated base portion extends. The membrane is flexible and extends from one branch to the other branch while passing around the longitudinal hoop. The membrane may be connected to the branches without being stretched between the branches and the hoop so that the membrane forms lateral portions on each side of the implant that are able to transition between an outwardly convex, concave shape, and an outwardly concave, recessed shape.

Claims

1. An intervalvular implant for a mitral valve, the implant comprising:

a frame having an elongated base portion formed by first and second branches, each of the first and second branches having a curved or chevron shape, a first end portion, a median portion, and a second end portion, the median portions of the first and second branches spaced apart a width from each other, the first end portion of the first branch coupled to the first end portion of the second branch at a first connection area, the second end portion of the first branch coupled to the second end portion of the second branch at a second connection area, the first and second connection areas spaced apart a length from each other such that the length is three to eight times greater than the width between the median portions of the first and second branches,

wherein the frame further comprises first and second anchoring portions connected to the first and second connection areas, respectively, the first and second anchoring portions configured to allow the implant to be anchored to an annulus of the mitral valve at two points of the annulus spaced apart and opposite each other,

wherein the frame further comprises a longitudinal hoop extending from the first connection area to the second connection area; and

a flexible membrane configured to extend from the first branch to the second branch while passing around the longitudinal hoop so that the flexible membrane forms a first lateral portion and a second lateral portion, the flexible membrane coupled to the first and second branches so that the first and second lateral portions of the flexible membrane are transitionable between a convex shape and a concave shape,

wherein the flexible membrane is affixed to the first and second branches.

2. The implant of claim 1, wherein the first and second end portions of the first and second branches have tilted portions and/or the first and second connection areas are tilted or have tilted portions so as to shift the elongated base portion on a ventricular side of the implant relative to a surface of the annulus through which the first and second anchoring portions are intended to come into contact with the annulus.

3. The implant of claim 1, wherein the first and second connection areas and the first and second anchoring portions substantially extend in the direction of extension of the elongated base portion so that the elongated base portion is located in a plane close to a plane of the surface of the annulus through which the first and second anchoring portions are intended to come into contact with the annulus.

4. The implant of claim 1, wherein the first and second branches are positioned symmetrically relatively to a longitudinal median plane of the implant, so that the elongated base portion has an oval or rhombic shape.

5. The implant of claim 1, wherein convex or protruding sides of the first and second branches, resulting from the curved or chevron shape of the first and second branches, are turned towards a same side of the implant, ensuring that the elongated base portion has a general curved shape, substantially adapted to a curvature exhibited by a space delimited by the mitral valve.

6. The implant of claim 1, wherein the longitudinal hoop is located in a longitudinal median plane of the implant.

7. The implant of claim 1, wherein the longitudinal hoop is located in a plane substantially perpendicular to a plane in which the elongated base portion extends.

8. The implant of claim 1, wherein the first and second anchoring portions each have a hole configured to receive a tie for anchoring the implant to the annulus, the hole having a hole length positioned perpendicularly to the length of the implant between the first and second connection areas.

9. The implant of claim 1, wherein the flexible membrane extends along at least a portion of the implant over the longitudinal hoop.

10. The implant of claim 1, wherein the flexible membrane passes around the longitudinal hoop by bearing against the longitudinal hoop.

11. The implant of claim 1, wherein the flexible membrane is only coupled to the first and second branches without being coupled to the longitudinal hoop.

12. The implant of claim 1, wherein the flexible membrane is coupled both to the first and second branches and to the longitudinal hoop.

13. The implant of claim 1, wherein the frame comprises an elastically deformable material configured to allow the frame to adopt a deformed configuration, with transverse contraction, in which the frame may be placed in a delivery catheter, and a normal expansion configuration, in which the frame may be implanted.

14. The implant of claim 1, wherein the first and second anchoring portions are positioned on a longitudinal axis parallel to a longitudinal axis extending between the first and second connection areas.