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CA-3184935-C - EXTERIORLY MOUNTED TISSUE ON EXPANDABLE FRAME FOR IMPROVED HEMODYNAMIC PERFORMANCE

CA3184935CCA 3184935 CCA3184935 CCA 3184935CCA-3184935-C

Abstract

A replacement heart valve prosthesis for transcatheter repair of a native valve comprises a frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an exterior surface and an interior surface defining a lumen, the frame expandable from an unexpanded state to an expanded state. The frame further comprises an expandable region near the distal end of the frame and a cusp region near the proximal end of the frame. The cusp region has a plurality of valve attachment features. A valve construct is mounted to the exterior surface of the frame and attached to the frame at least at the valve attachment features.

Inventors

  • Ramji Iyer
  • DAVID LAWRENCE ST. DENIS
  • Samuel Thomas Johnson
  • William Morris Leonard Neethling
  • Martha Jeanne ENGEL

Assignees

  • ANTERIS TECHNOLOGIES CORPORATION

Dates

Publication Date
20260505
Application Date
20210707
Priority Date
20200707

Claims (15)

  1. 37 CLAIMS 1. A replacement heart valve for transcatheter repair of a native valve, the replacement heart valve comprising: an expandable frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an exterior surface and an interior surface defining a lumen, the frame expandable from an unexpanded state to an expanded state, wherein the frame further comprises: an expandable region near the distal end of the frame; and a cusp region near the proximal end of the frame, the cusp region comprising a plurality of posts; and a valve construct comprising a single piece of molded material that defines a plurality of slits, wherein the plurality of posts extend through the plurality of slits such that portions of the valve construct are mounted to the exterior surface of the frame.
  2. 2. The replacement heart valve of claim 1, wherein the cusp region has a third post.
  3. 3. The replacement heart valve of claim 1 or 2, wherein the strut is an arched strut.
  4. 4. The replacement heart valve of claim 1, wherein the cusp region further comprises a third post and the valve construct further comprises a second shaped leaflet, and further wherein the second shaped leaflet spans a second cusp opening defined at least by the second post and the third post.
  5. 5. The replacement heart valve of claim 4, wherein the valve construct has a shaped commissural region between the first shaped leaflet and the second shaped leaflet.
  6. 6. The replacement heart valve of claim 4 or 5, further comprising a third cusp opening defined at least by the third post and the first post, and a third shaped leaflet spanning the third cusp opening.
  7. 7. The replacement heart valve of any one of claims 1 to 6, wherein the valve construct is a single piece valve construct formed from a biomaterial.
  8. 8. The replacement heart valve of claim 7, wherein the biomaterial is selected from the group of: a polymer, bovine tissue, and porcine tissue. 38
  9. 9. The replacement heart valve of any one of claims 1 to 8, wherein the expandable region has at least a first row of cells at a distal end and a second row of cells at a proximal end of the expandable region.
  10. 10. The replacement heart valve of claim 9, wherein the expandable region has a plurality of middle row cells between the first row of cells and the second row of cells.
  11. 11. The replacement heart valve of any one of claims 1 to 10, wherein the frame has a longitudinal axis, and the posts are axially aligned with the longitudinal axis.
  12. 12. The replacement heart valve of any one of claims 1 to 11, wherein the cusp region further comprises cusp region cells defined by at least one cusp connector strut.
  13. 13. The replacement heart valve of any one of claims 1 to 8, 11 and 12, wherein the expandable region has a proximal end and a distal end, and a plurality of end nodes at the proximal end, and the first cusp strut is connected to a first end node of the expandable region.
  14. 14. The replacement heart valve of claim 13, wherein the second cusp strut is connected to the first end node.
  15. 15. The replacement heart valve of any one of claims 1 to 14, wherein the valve attachment features are selected from the group consisting of slots, hooks, loops, and pledgets.

Description

EXTERIORLY MOUNTED TISSUE ON EXPANDABLE FRAME FOR IMPROVED HEMODYNAMIC PERFORMANCE Background of the Invention [001] The present disclosure relates to novel and advantageous expandable frames for use with a transcatheter replacement heart valve prosthesis, and methods for attaching a valve construct to the frame. [002] The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure. [003] Transcatheter valve replacement (TVR) is a minimally invasive heart procedure to repair or replace a valve of the heart by using an implantable valve prosthesis delivered to the patient’s native valve via a catheter. The implantable valve prosthesis typically comprises an expandable frame with multiple flat prosthetic leaflets attached to the interior of the expandable frame. The prosthetic leaflets are intended to mimic the action of healthier native leaflets. The expandable frame may either be self-expanding using a shape memory alloy or may be expandable with a balloon or otherwise mechanically expandable when deployed into the native valve. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. TVR procedures typically involve the introduction of a catheter to the patient’s vasculature transfemorally, where the valve prosthesis is loaded into the catheter and advanced through the patient’s vasculature to the native valve. [004] Before these minimally invasive transcatheter valve replacement procedures were developed, the options for most patients needing to their heart valve repaired were limited to significantly invasive surgical replacement procedures. Yet for many patients needing heart valve repair, surgical repair posed a relatively high risk or the patient was not a viable candidate for surgery. With respect to the aortic valve, transcatheter aortic valve replacement (TAVR) procedures have been widely adopted by clinicians throughout the world as an alternative to surgical replacement procedures to treat these high-risk patients having severe aortic stenosis or similar conditions. With many procedures over the CA 03184935 2023- 1-4WO 2022/010958 PCT/US2021/040596 decades, TAVR has been shown to improve long term survival of these patients. Additionally, in recent years, several studies involving both balloon-expandable and self¬ expanding TAVR prostheses demonstrated that TAVR procedures showed effectiveness for patients with low surgical risk, and in 2019, the U.S. Food & Drug Administration expanded the TAVR indication to include these low-risk patients. [005] The development of TAVR prostheses, and the related prior art, has focused significantly on the mechanisms and methods for delivering the prosthesis to the native valve, positioning or re-positioning the prosthesis relative to the native valve structure or surrounding anatomical structure, and reducing the French size of the catheter for improvement of delivery through the vascular. However, this development has not focused especially on long-term use and hemodynamic performance of the prostheses over time. Many of the TAVR prostheses currently used in these procedures have shown significant calcification, as well as deterioration or degradation of the prosthesis. Over time, typically between five and fifteen years, many TAVR valve prostheses degenerate and eventually fail, requiring the patient to then have the valve prostheses repaired. In recent years, a second valve may be provided to a patient with a failed TAVR prostheses in a procedure called “valve-m-valve” TAVR. In these procedures, a new transcatheter valve is inserted into the lumen of the failed TAVR valve, pushing the prosthetic leaflets aside. Inserting a valve into the lumen of the failed TAVR valve, necessarily restricts or reduces the effective orifice area, and thus limits the hemodynamic performance of this second valve. [006] As younger, lower-risk patients receive TAVR prostheses, there is a need for a more durable valve that effectively resists calcification and degradation of the prosthesis. Further, there is a need in the art for a durable heart valve that also achieves improved hemodynamic performance, in addition to its longevity. Brief Summary of the Invention [007] The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments, and is intended to neither identify key or critical elements of all embodiments, nor delineate the scope of any or all embodiments. CA 03184935 2023- 1-4WO 2022/010958 PCT/US2021/040596 [008] The