Proximal tab for side-delivered transcatheter heart valve prosthesis

• US 10,653,522 B1
• Filed: 06/27/2019
• Issued: 05/19/2020
• Est. Priority Date: 12/20/2018
• Status: Active Grant

• Current Assignee: Vdyne, Inc.
• Original Assignee: Vdyne, Inc.
• Inventors: Vidlund, Robert, Christianson, Mark, Saikrishnan, Neelakantan
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Bachman, Lindsey
• Application Number:
  US16/455,417
• Time in Patent Office: 327 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular Compression Capable Annular Frames for a side delivered transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.

Claims

1. A method for delivering a prosthetic heart valve to an annulus of a native valve between a ventricle and an atrium of a heart, the method comprising the steps:

(i) disposing in the atrium of the heart a distal portion of a delivery catheter having a lumen and a longitudinal axis, with a distal end of the delivery catheter directed towards the annulus of the native valve, the distal portion of the delivery catheter having disposed within the lumen thereof the prosthetic heart valve in a compressed configuration,

wherein the compressed configuration of the prosthetic heart valve has a long-axis substantially parallel to a length-wise cylindrical axis of the delivery catheter,

wherein the expanded configuration of the prosthetic heart valve has a height of about 5-60 mm and a diameter of about 25-80 mm,

wherein the prosthetic heart valve comprises an annular support frame having a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

wherein the annular support frame is self-expanding or balloon-expandable,

a distal anchoring tab is mounted on a distal side of the annular support frame, the distal anchoring tab having a length of 10-40 mm, the distal anchoring tab extending laterally from the annular support frame and is configured to be disposed on a ventricle side of the annulus of the native valve when the annular support frame is disposed within the annulus,

at least one proximal anchoring tab is mounted on a proximal side of the annular support frame, the proximal anchoring tab having a length of 2-25 mm, the at least one proximal anchoring tab extending laterally from the annular support frame and is configured to be disposed on the ventricle side of the annulus of the native valve when the annular support frame is disposed within the annulus;

(ii) partially releasing the prosthetic heart valve from the delivery catheter, and positioning the distal anchoring tab at a distal subannular anchoring area, wherein positioning the distal anchoring tab holds the prosthetic heart valve at a raised angle of at least 30 degrees to a localized annular plane relative to a horizontal axis of the valve, and

wherein partially releasing the prosthetic heart valve permits blood to flow partially around the prosthetic heart valve and through the native leaflets, and partially through the flow control component of the prosthetic valve to provide a gradual blood flow transition from flow through native leaflets to complete flow through the prosthetic valve,

wherein the distal subannular anchoring area is a right ventricular outflow tract (RVOT) of a right ventricle or is a sub-annular area below an A1-P1 antero-lateral commissure of a mitral valve;

(iii) completing release of the entire prosthetic heart valve from within the lumen of the delivery catheter, and seating the prosthetic heart valve in the native annulus by applying a downward force in the direction of the ventricle; and

(iv) seating the proximal anchoring tab at a proximal subannular anchoring area.

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

3. The method of claim 1 wherein seating the proximal anchoring tab comprises releasing the proximal anchoring tab from a compressed pre-release configuration to an expanded post-release configuration with the proximal anchoring tab extending into the proximal subannular anchoring area.

4. A method for orthogonal delivery of implantable prosthetic heart valve in the body, the method comprising the steps:

(i) advancing a distal end of a guide wire to a distal location, wherein the distal location is a pulmonary artery or a left ventricle of a heart, wherein the guide wire starts outside of a patient using femoral vein access or brachiocephalic vein access, and extends through an inferior vena cava or a superior vena cava to a right atrium, and extends from the right atrium through the tricupsid valve to the pulmonary artery or extends from the right atrium across the atrial septum in a transeptal access through the mitral valve and into a left ventricle;

(ii) advancing a delivery catheter over the guide wire to a target location, where the target location is a right atrium of the tricuspid valve or a left atrium of the mitral valve;

(iii) advancing and delivering an orthogonally compressed self-expandable prosthetic heart valve to the target location in the body,

wherein a compressed configuration of the valve has a long-axis substantially parallel to a length-wise cylindrical axis of the delivery catheter,

wherein the expanded configuration of the valve has a height of about 5-60 mm and a diameter of about 25-80 mm,

wherein the valve comprises an annular support frame having a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

a distal anchoring tab is mounted on a distal side of the annular support frame, the distal anchoring tab having a length of 10-40 mm and a width of 2-10 mm, wherein the guide wire is threaded through a threading aperture on or within the distal anchoring tab,

at least one proximal anchoring tab is mounted on a proximal side of the annular support frame, the proximal anchoring tab having a length of 2-25 mm and a width of 2-10 mm, and

a valve advancing tool comprising an elongated sheath wherein the guide wire is within a lumen of the sheath, wherein the outer diameter of the sheath is larger than the inner diameter of the threading aperture on the distal anchoring tab, wherein when the sheath is advanced over the guide wire in a distal direction, and a distal end of the sheath contacts a proximal surface of the threading aperture, the valve is advanced distally through the delivery catheter by the distally-directed pulling force that the sheath imparts to the distal anchoring tab;

(iv) partially releasing the valve from the delivery catheter by advancing the sheath over the guide wire, and positioning the distal anchoring tab at a desired anchoring area of the target location,

wherein the desired anchoring area is selected from a right ventricular outflow tract (RVOT) of a right ventricle, and a sub-annular area below an A1-P1 antero-lateral commissure of a mitral valve,

wherein positioning the distal anchoring tab holds the valve at a raised angle of at least 30 degrees to a localized annular plane relative to the horizontal axis of the valve and the delivery catheter,

wherein partially releasing the valve permits blood to flow partially around the prosthetic valve and through the native leaflets, and partially through the flow control component of the prosthetic valve to provide a gradual blood flow transition from flow through native leaflets to complete flow through the prosthetic valve;

(v) completing release of the entire valve from the delivery catheter by advancing the sheath over the guide wire, seating the valve in the native annulus by applying a downward force in the direction of the ventricle; and

(vi) seating the at least one proximal anchoring tab at a second desired anchoring area.

5. The method of claim 4, comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.