Disk-based valve apparatus and method for the treatment of valve dysfunction

• US 10,456,255 B2
• Filed: 05/19/2014
• Issued: 10/29/2019
• Est. Priority Date: 03/21/2011
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: Montorfano, Matteo, Chieffo, Alaide, Granada, Juan F.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/281,714
• Publication Number:
  US 20140257476A1
• Time in Patent Office: 1,989 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Claims

1. A method of deploying a prosthetic cardiac valve in a patient, the method comprising:

inserting the prosthetic cardiac valve in a collapsed configuration within a dysfunctional mitral valve in the patient'"'"'s heart, the prosthetic cardiac valve including a distal portion, a proximal portion, and a central portion therebetween;

permitting the distal portion to self-expand such that the distal portion flares radially outward relative to the collapsed configuration and relative to the central portion, the flared distal portion forming a distal disk having a convex annular shape such that the distal disk points distally;

pulling the distal disk proximally into a plane of the dysfunctional mitral valve;

engaging mitral valve tissue with a plurality of hooks disposed on the distal disk proximal to a distal end of the prosthetic cardiac valve;

permitting the proximal portion to self-expand on an opposite side of the dysfunctional mitral valve such that the proximal portion flares radially outward relative to the collapsed configuration and relative to the central portion, the flared proximal portion forming a proximal disk, wherein pulling the distal disk proximally occurs prior in time to permitting the proximal portion to self-expand; and

permitting the central portion of the valve anchor to self-expand within the dysfunctional mitral valve to move the distal and proximal disks toward each other to compress the dysfunctional mitral valve.

2. The method of claim 1, wherein the distal portion further comprises a plurality of interconnected loops that form the distal disk when the distal portion self-expands.

3. The method of claim 2, wherein tips of the loops point distally when the distal portion forms a disk having a convex shape.

4. The method of claim 1, wherein the proximal portion further comprises a plurality of interconnected loops that form the proximal disk when the proximal portion self-expands.

5. The method of claim 1, wherein pulling the distal disk proximally into a plane of the dysfunctional mitral valve comprises pulling the distal disk proximally such that the distal disk forms a convex annular shape around the dysfunctional mitral valve.

6. A prosthetic cardiac valve, comprising:

a distal portion, a proximal portion, and a central portion therebetween;

wherein the distal portion is self-expandable from a collapsed configuration to an expanded configuration, the distal portion in the expanded configuration shaped as a distal disk that is flared radially outward relative to the collapsed configuration of the distal portion and relative to the central portion, the distal disk having a convex annular shape such that the distal disk point distally, and the distal portion in the expanded configuration further comprising a plurality of hooks;

wherein the proximal portion is self-expandable from a collapsed configuration to an expanded configuration, the proximal portion in the expanded configuration shaped as a proximal disk that is flared radially outwards relative to the collapsed configuration of the proximal portion and relative to the central portion; and

wherein the central portion is configured to self-expand to move the proximal and distal portions towards one another.

7. The prosthetic mitral valve of claim 6, wherein the distal disk comprises a plurality of interconnected loops.

8. The prosthetic mitral valve of claim 7, wherein tips of the loops point distally when the distal portion is in the expanded configuration.

9. The prosthetic mitral valve of claim 6, wherein the proximal disk further comprises a plurality of interconnected loops.

10. The prosthetic mitral valve of claim 6, wherein the prosthetic mitral valve comprises a shape memory material.

11. The prosthetic mitral valve of claim 10, wherein the shape memory material is Nitinol.

12. The prosthetic mitral valve of claim 6, wherein the prosthetic mitral valve comprises a plurality of wires that form the proximal, distal, and central portions.