Implantable device for treating mitral valve regurgitation

• US 9,839,517 B2
• Filed: 09/25/2015
• Issued: 12/12/2017
• Est. Priority Date: 09/26/2014
• Status: Active Grant

• Current Assignee: Medira AG
• Original Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Inventors: Centola, Marcos, Kawa, Emilia
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US14/865,436
• Publication Number:
  US 20160089238A1
• Time in Patent Office: 809 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

An implantable device for treating mitral valve regurgitation, the device being configured to expand from a compressed state into an expanded state. The device comprises a stent element consisting of (i) an atrial anchoring stent-portion, and (ii) a valve-carrying stent-portion being fixedly connected with one another, and a valve-element. The atrial anchoring stent-portion has a balloon-like shape and the valve-carrying stent-portion has a cylindrical shape, such, that the valve-carrying stent-portion is positioned intra-annular without contacting the annulus of a native mitral valve.

Claims

1. Implantable device for treating mitral valve regurgitation, the device being configured to expand from a compressed state into an expanded state, and comprising:

a stent element comprising

an atrial anchoring stent-portion, and

a valve-carrying stent-portion,

the atrial anchoring stent-portion being fixedly connected with the valve-carrying stent-portion,

wherein the atrial anchoring portion, in the expanded state of the device, has a balloon-like shape and is so dimensioned as to have a diameter which is larger than a diameter of an annulus of a native mitral valve present between an atrium and a ventricle of a heart to be treated, and is so dimensioned and configured to anchor the device via radial force in an atrium of a heart to be treated when the device is in the expanded state,

wherein the valve-carrying stent-portion, in the expanded state of the device, has a substantially cylindrical shape with a diameter (d3) which, in the expanded state, is so dimensioned as to be smaller than a diameter of an annulus of a native mitral valve of a heart to be treated, such that there is no contact between the annulus of the native mitral valve and the valve-carrying stent-portion; and

a valve element comprising a skirt-portion and a valve-portion, the skirt-portion being externally mounted to the valve-carrying stent-portion, and the valve-portion being internally mounted to the valve-carrying stent-portion.

2. The device of claim 1, wherein, when implanted, the valve-element is so dimensioned and configured such that the native mitral valve'"'"'s function is supported without replacing or impairing the native mitral valve'"'"'s function.

3. The device of claim 1, wherein the atrial anchoring stent-portion and the valve-carrying stent-portion are integrally formed.

4. The device of claim 1, wherein the atrial anchoring stent-portion is configured to be anchorable in an atrium of a heart.

5. The device of claim 1, wherein the skirt-portion and the valve-portion of the valve element are made of a same material.

6. The device of claim 5, wherein the skirt-portion and the valve-portion of the valve element are made of pericardium.

7. The device of claim 1, wherein the valve element is a bi- or tri-leaflet valve.

8. The device of claim 1, wherein the stent-element is made of a shape-memory material.

9. The device of claim 8, wherein the stent-element is a laser-cut stent-element and/or composed of wires.

10. The device of claim 8, wherein the atrial anchoring stent-portion and/or the valve-carrying stent-portion is made from braided or otherwise intersected wires.

11. The device of claim 8, wherein the atrial anchoring stent-portion and/or the valve-carrying stent-portion is made from wire-loops.

12. The device of claim 8, wherein the stent-element is made of ninitol.

13. The device of claim 1, wherein the substantially cylindrical shape of the valve-carrying stent-portion, in the expanded state of the device, has a substantially continuous diameter (d3) along its cylindrical length (l).

14. Method for treating mitral valve regurgitation, the method comprising the step of deploying the device as claimed in claim 1 in a heart of a patient in need of being treated.