Distal subannular anchoring tab for side-delivered transcatheter valve prosthesis

• US 10,631,983 B1
• Filed: 06/11/2019
• Issued: 04/28/2020
• Est. Priority Date: 03/14/2019
• Status: Active Grant

• Current Assignee: Vdyne, Inc.
• Original Assignee: Vdyne, Inc.
• Inventors: Christianson, Mark, Vidlund, Robert
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US16/438,434
• Time in Patent Office: 322 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

The invention relates to a distal anchoring tab for an orthogonally delivered prosthetic mitral valve where the tab is extended using a guide wire to capture native mitral leaflet and/or chordae tissue and withdrawing the guide wire contracts the tab and pins the native tissue against the subannular sidewall of the prosthetic valve.

Claims

1. A method for delivery of an implantable prosthetic mitral valve between a ventricle and an atrium of a heart of a patient, the method comprising the steps:

advancing a guide wire trans-septally to the atrium, through an annular plane of a native valve of the patient;

advancing to the atrium of the patient a delivery catheter containing the prosthetic valve in an orthogonally compressed configuration, wherein the prosthetic valve comprises (i) a self-expanding outer support frame, said outer support frame having a central channel and a D-shaped outer perimeter wall circumscribing a central vertical axis in an expanded configuration, said outer support frame having a distal side and a proximal side,

(ii) a collapsible inner flow control component mounted within the outer support frame,

the outer support frame and the leaflet frame comprising diamond- or eye-shaped wire cells made from heat-set Nitinol and configured to be foldable along a z-axis from a rounded or cylindrical configuration to a flattened cylinder configuration having a width of 8-12 mm, and compressible along a vertical axis y-axis to a shortened configuration having a height of 8-12 mm,

a leaflet frame with 2-4 flexible leaflets is mounted within the collapsible inner flow control component, wherein the 2-4 leaflets are configured to permit blood flow in a first direction through an inflow end of the flow control component and block blood flow in a second direction, opposite the first direction, through an outflow end of the flow control component;

(iii) an elongated distal anchoring member mounted on the distal side of the outer support frame, wherein the anchoring member threadably engages with the guide wire and tracks over the guide wire during deployment,

wherein the prosthetic valve is 40-80 mm along a horizontal axis, has an expanded height of 5-60 mm and a compressed height of 8-12 mm, and has an expanded width of 25-80 mm and a compressed width of 8-12 mm, wherein the prosthetic valve in a compressed configuration fits within the inner diameter of a 24-36 Fr (8-12 mm inner diameter) delivery catheter for introduction into the body,

wherein the horizontal axis of the prosthetic valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter;

releasing the prosthetic valve from the delivery catheter, wherein the anchoring member tracks over the guide wire during release;

advancing the prosthetic valve over the guide wire to move the anchoring member to a subannular position and to seat the prosthetic valve into the native annulus; and

,

withdrawing the guide wire to release the anchoring member to capture native leaflet and/or native chordae.

2. The method of claim 1, wherein releasing the valve from the delivery catheter is selected from the steps consisting of:

(i) pulling the valve out of the delivery catheter using a rigid elongated pushing rod/draw wire that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the proximal side of the valve, wherein advancing the pushing rod out of from the delivery catheter pushes the compressed valve out of the delivery catheter.

3. The method of claim 1, comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

4. The method of claim 1, comprising the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus.

5. The method of claim 1, wherein the inner flow control component is mounted in an offset position within the outer support frame, and wherein the inner flow control component has a diameter of 25-29 mm.