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US-12616572-B2 - Devices, systems, and methods for a valve replacement

US12616572B2US 12616572 B2US12616572 B2US 12616572B2US-12616572-B2

Abstract

Disclosed are valve replacement devices, systems, and methods. Valve replacement devices may comprise one- or two-piece systems comprising a receiver body (also called an adapter) and a valve assembly with replacement leaflets attached to and located within the receiver body. In two-piece systems, the valve assembly may be removable from the receiver body such that both can be delivered together or separately, and the receiver body may remain implanted while the valve assembly may be removed and replaced. Also described are devices, systems, and methods related to delivering, removing, and replacing a valve replacement. Such delivery methods may include transseptal insertion of a new minimum leaflet structure, and securement of the valve replacement using several securement type (e.g., supra-annular, sub-annular, radial, leaflet securement, etc.). Also described is a braided helical design that mimics the heart's natural movement, and a flange structure for assisting the functioning of the valve replacement.

Inventors

  • Julie Logan Sands
  • Kenneth Eugene Perry
  • Anthony Zoltan Zador
  • Kevin Stewart
  • Behnood Miri
  • Nikolai Poulsen
  • Taylor Scheinblum
  • Hieu Luong
  • Christopher Olson

Assignees

  • ReValve Solutions, Inc.

Dates

Publication Date
20260505
Application Date
20250623

Claims (20)

  1. 1 . A prosthetic mitral valve, comprising: a tubular body comprising a first braided wire, an inflow end and an outflow end, and a height between the inflow and outflow ends; a flange comprising a second braided wire woven into the first braided wire of the tubular body, the flange comprising a portion extending radially outwardly from an intermediate portion of the height of the tubular body and towards the inflow end of the tubular body, and the flange comprising a curved section and a D-shaped perimeter, wherein the flange's curved section comprises a convex section and a concave section with an inflection point therebetween; a medial stabilizer extending medially from a lower portion of the height of the tubular body at the outflow end; a lateral stabilizer extending laterally from a lower portion of the height of the tubular body at the outflow end; a posterior leaflet clip extending posteriorly from a lower portion of the height of the tubular body at the outflow end, the posterior leaflet clip configured to capture a P 2 region of a native posterior mitral leaflet; and an anterior leaflet clip extending anteriorly from a lower portion of the height of the tubular body at the outflow end, the anterior leaflet clip configured to capture an A 2 region of a native anterior mitral leaflet.
  2. 2 . A prosthetic mitral valve as in claim 1 , wherein the first braided wire of the tubular body comprises at least 8 peaks and no more than 16 peaks the outflow end and at least 8 peaks and no more than 16 peaks at the inflow end of the tubular body.
  3. 3 . A prosthetic mitral valve as in claim 2 , wherein the second braided wire of the flange comprises at least 8 peaks and no more than 16 peaks at the outflow end of the tubular body and at least 8 peaks and no more than 16 peaks along the D-shaped perimeter of the flange.
  4. 4 . A prosthetic mitral valve as in claim 3 , wherein the first braided wire of the tubular body comprises 12 peaks at the outflow end and 12 peaks at the inflow end of the tubular body and wherein the second braided wire of the flange comprises between 12 peaks at the outflow end of the tubular body and 12 peaks along the D-shaped perimeter of the flange.
  5. 5 . A prosthetic mitral valve as in claim 1 , wherein the posterior and anterior leaflet clips extend from a lower third portion of the receiver, are inclined towards a left atrium when deployed in the native mitral valve, and resist migration of the prosthetic mitral valve towards the inflow end.
  6. 6 . A prosthetic mitral valve as in claim 1 , wherein the medial and lateral stabilizers are inclined towards a left atrium when deployed in the native mitral valve and resist migration of the prosthetic mitral valve towards the inflow end.
  7. 7 . A prosthetic mitral valve as in claim 1 , wherein at least a portion of the flange is configured to rest in a supra-annular space when deployed in the native mitral valve and resist migration of the prosthetic mitral valve towards the outflow end.
  8. 8 . A prosthetic mitral valve as in claim 1 , wherein at least a portion of the flange's D-shaped perimeter is configured to rest on top of the atrial floor and wherein at least a portion of the flange's D-shaped perimeter is configured to rest at an aortic-mitral curtain area when the flange is deployed in the native mitral valve.
  9. 9 . A prosthetic mitral valve as in claim 1 , wherein the second braided wire of the flange comprises peaks along the D-shaped perimeter of the flange, wherein the peaks of the flange comprise a petal shape near the inflow end of the tubular body.
  10. 10 . A prosthetic mitral valve as in claim 1 , wherein at least a portion of the flange's curved section is configured to rest in an intra-annular space of a native mitral annulus when deployed in a native mitral valve, and wherein at least a portion of the flange's concave portion is configured to rest in a supra-annular space of the native mitral annulus when deployed in the native mitral valve.
  11. 11 . A prosthetic mitral valve as in claim 10 , wherein at least a portion of the flange's curved section transitions into the D-shaped perimeter and wherein at least a portion of the flange's D-shaped perimeter comprises a circular flange section that is configured to rest in an intra-annular space when deployed in the native mitral valve.
  12. 12 . A prosthetic mitral valve, comprising: a receiver body comprising a first braided wire, an inflow end and an outflow end, and a height between the inflow and outflow ends; a flange comprising a second braided wire woven into the first braided wire of the receiver body, the flange comprising a portion extending radially outwardly from an intermediate portion of the height of the receiver body and towards the inflow end of the receiver body, and the flange comprising a curved section and a D-shaped perimeter, wherein at least a portion of the flange's curved section is configured to rest in an intra-annular space of a native mitral annulus when deployed in a native mitral valve, and wherein at least a portion of the flange's D-shaped perimeter is configured to rest on top of the native mitral annulus when deployed in the native mitral valve, wherein the flange resists migration of the prosthetic mitral valve towards the outflow end.
  13. 13 . A prosthetic mitral valve as in claim 12 , wherein the height of the receiver body is between 17 to 26 millimeters and wherein the receiver body has an inner diameter of between 25 to 34 millimeters.
  14. 14 . A prosthetic mitral valve as in claim 13 , further comprising an anterior leaflet clip extending anteriorly from a lower portion of the height of the receiver body at the outflow end, the anterior leaflet clip configured to capture an A 2 region of a native anterior mitral leaflet, a posterior leaflet clip extending posteriorly from a lower portion of the height of the receiver body at the outflow end, the posterior leaflet clip configured to capture a P 2 region of a native posterior mitral leaflet, wherein the anterior and posterior leaflet clips extend from the first braided wire of the receiver body.
  15. 15 . A prosthetic mitral valve as in claim 14 , wherein the anterior leaflet clip comprises a curved wire that exits the receiver body at a first location along a circumference of the receiver body and re-enters the receiver body at a second location along the circumference of the receiver body, wherein the first and second locations along the circumference of the receiver body are separated by a width of between 4 to 15 millimeters and wherein the curved wire of the anterior leaflet clip comprises a widest point between the curved wire of between 8 to 16 millimeters.
  16. 16 . A prosthetic mitral valve as in claim 15 , wherein the posterior leaflet clip comprises a curved wire that exits the receiver body at a third location along the circumference of the receiver body and re-enters the receiver body at a fourth location along the circumference of the receiver body, wherein the third and fourth locations along the circumference of the receiver body are separated by a width of between 4 to 15 millimeters and wherein the curved wire of the posterior leaflet clip comprises a widest point between the curved wire of between 6 to 14 millimeters.
  17. 17 . A prosthetic mitral valve as in claim 16 , wherein the anterior and posterior leaflet clips each comprise a height of between 10 to 19 millimeters.
  18. 18 . A prosthetic mitral valve as in claim 13 , further comprising a medial stabilizer extending medially from a lower portion of the height of the receiver body at the outflow end and a lateral stabilizer extending laterally from a lower portion of the height of the receiver body at the outflow end, wherein the medial and lateral stabilizers extend from the second braided wire of the flange.
  19. 19 . A prosthetic mitral valve as in claim 18 , wherein the medial stabilizer comprises a curved wire that exits the receiver body at a fifth location along the circumference of the receiver body and re-enters the receiver body at a sixth location along the circumference of the receiver body, wherein the fifth and sixth locations along the circumference of the receiver body are separated by a width of between 4 to 15 millimeters and wherein the curved wire of the medial stabilizer comprises a widest point between the curved wire of between 6 to 18 millimeters.
  20. 20 . A prosthetic mitral valve as in claim 19 , wherein the lateral stabilizer comprises a curved wire that exits the receiver body at a seventh location along the circumference of the receiver body and re-enters the receiver body at an eighth location along the circumference of the receiver body, wherein the seventh and eighth locations along the circumference of the receiver body are separated by a width of between 4 to 15 millimeters and wherein the curved wire of the lateral stabilizer comprises a widest point between the curved wire of between 6 to 18 millimeters.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This application claims priority to U.S. App No. 63/699,156, filed on Sep. 25, 2024. This application is a continuation in-part of U.S. application Ser. No. 18/694,897, filed on Mar. 22, 2024, which is a National Stage Entry of International App. No. PCT/US22/48304, filed Oct. 28, 2022, which claims priority and benefit to U.S. App. No. 63/407,624, filed Sep. 17, 2022. This application is a continuation in-part of U.S. application Ser. No. 18/628,612, filed on Apr. 5, 2024, which is a continuation of U.S. application Ser. No. 18/275,988, filed on Aug. 4, 2023, which is a National Stage Entry of International App No. PCT/US22/15360, filed Feb. 4, 2022, which claims priority and benefit to U.S. App. No. 63/145,878, filed Feb. 4, 2021. This application is a continuation in-part of U.S. application Ser. No. 18/028,212, filed Mar. 23, 2023, which is a National Stage Entry of International App. No. PCT/US21/51828, filed Sep. 23, 2021, which claims priority and benefit to U.S. App. No. 63/082,035, filed Sep. 23, 2020. This application is a continuation in-part of U.S. application Ser. No. 17/925,590, filed Nov. 15, 2022, which is a National Stage Entry of International App. No. PCT/US21/32817, filed May 17, 2021, which claims priority and benefit to U.S. App. No. 63/025,881, filed May 15, 2020. This application is a continuation in-part of U.S. application Ser. No. 17/921,070, filed Oct. 24, 2022, which is a National Stage Entry of International App. No. PCT/US21/38886, filed Jun. 24, 2021, which claims priority and benefit to U.S. App. No. 63/015,353, filed Apr. 24, 2020, and U.S. App. No. 63/025,881, filed May 15, 2020. This application is a continuation in-part of U.S. application Ser. No. 17/240,914, filed on Apr. 26, 2021, which claims priority and benefit to U.S. App. No. 63/015,353, filed Apr. 24, 2020, and U.S. App No. 63/025,881, filed May 15, 2020. The contents of the above-referenced applications are incorporated herein by this reference as though set forth in their entirety. FIELD OF USE The present disclosure relates generally to replacement heart-valve technology, and more specifically to devices, systems, and methods for delivering a valve replacement or replacing a valve replacement. Aspects of the disclosure also relate to unique features of the innovative replacement heart valve technology, including a helical braided wire design of the replacement heart valve frame and a multipoint anchoring system that utilizes a combination of supra-annular anchoring that anchors to the top of the annulus of the native heart valve, sub-annular anchoring that anchors to the bottom of the annulus of the native heart valve, and selectable and customizable radial force within the replacement heart valve that anchors within the annulus of the native heart valve. In embodiments, the innovative replacement heart valve technology includes a “floating valve” that is anchored in the atrium (for example by a flange) and in the ventricle (for example with leaflet clips and medial and lateral stabilizers) with a valve size that is minimally oversized in comparison to a native mitral valve annulus in one of more of the anterior-to-posterior (A-P) and commissure-to-commissure (C-C) directions, thereby providing a valve that effectively floats in the native annulus yet is anchored in position. In embodiments, the innovative replacement heart valve technology includes a posterior directionality (which may include a posterior tilt and/or posterior positioning of the replacement valve towards the posterior wall in the ventricle) whereby flow through the replacement valve from the atrium to the ventricle travels in a posterior direction relative to the mitral annulus and/or left ventricular apex (as opposed to directly towards the native heart's apex or anterior segment) and fosters a more natural vortex flow into the left ventricle and through the left ventricular outflow tract (LVOT). In embodiments, the atrial flange, leaflet clips and stabilizers create a geometrical bias towards a posterior direction when deployed within the native mitral valve thereby promoting vortex blood flow between the native atrium and native ventricle areas and left ventricle outflow tract (LVOT) preservation. BACKGROUND Heart valve intervention, such as full open-heart surgery, is often required to treat diseases of one or more of the four heart valves (which work together to keep blood properly flowing through the heart). Replacement and/or repair of a heart valve is often required when a valve is “leaky” (e.g., there is valve regurgitation) or when a valve is narrowed and does not open properly (e.g., valve stenosis). Heart valve replacement, such as mitral valve or tricuspid valve replacement, typically involves replacement of the heart's original (native) valve with a replacement mechanical and/or tissue (bioprosthetic) valve. Common problems with the replacement of valves and/or the frames carrying them