Methods to improve the durability of polymeric heart valves

Patent metadata

Field	Value
Publication number	US-12458491-B2
Application number	US-202217648076-A
Country	US
Kind code	B2
Filing date	Jan 14, 2022
Priority date	Jun 30, 2017
Publication date	Nov 4, 2025
Grant date	Nov 4, 2025

Abstract

A transcatheter prosthetic heart valve includes a stent frame and a leaflet material. The stent frame includes a top portion and a bottom portion. The leaflet material includes a lower portion attached to the stent frame and an upper portion that includes leaflets capable of moving between an open configuration and a closed configuration. At least a portion of the leaflet material weaves through the stent frame. The transcatheter prosthetic heart valve also includes one or more reinforcement components coupled to the stent frame and/or to the leaflet material to enhance performance of the transcatheter heart valve.

First claim

The invention claimed is:

1 . A transcatheter prosthetic heart valve, comprising:
a stent frame comprising a top portion and a bottom portion; a leaflet material comprising:
a lower portion attached to the stent frame; and
an upper portion comprising leaflets that are capable of moving between an open configuration and a closed configuration, wherein at least a portion of the leaflet material weaves through the stent frame; and
one or more reinforcement components coupled to the stent frame and/or to the leaflet material to enhance performance of the transcatheter heart valve, wherein the one or more reinforcement components comprise fibers tracing stress-concentrated lines along the leaflets.

2 . The transcatheter prosthetic heart valve of claim 1 , wherein the leaflet material is shaped via thermoforming process.

3 . The transcatheter prosthetic heart valve of claim 2 , wherein the geometry of the leaflet material is determined based on based optimization using finite element modeling.

4 . The transcatheter prosthetic heart valve of claim 2 , wherein the thermoforming process comprises one or more steps of vacuum forming, pressure forming, molding, compressing, heating, annealing, tempering, cold working, and stretching.

5 . The transcatheter prosthetic heart valve of claim 1 , wherein the one or more reinforcement components comprise one or more shock absorbers wrapped around at least a portion of the stent frame.

6 . The transcatheter prosthetic heart valve of claim 5 , wherein the one or more shock absorbers are formed from a liquid state and molded to surround at least a portion of the stent frame.

7 . The transcatheter prosthetic heart valve of claim 5 , wherein the one or more shock absorbers are formed from a solid state and shaped to surround at least a portion of the stent frame.

8 . The transcatheter prosthetic heart valve of claim 1 , wherein the one or more reinforcement components comprise one or more clamps to hold the top portion and the bottom portion of the stent frame together with the leaflet material anchored between the top portion and the bottom portion of the stent frame.

9 . The transcatheter prosthetic heart valve of claim 1 , wherein the one or more reinforcement components comprise one or more clips that anchor the leaflet material between the top portion and the bottom portion of the stent frame.

10 . The transcatheter prosthetic heart valve of claim 1 , wherein the fibers comprise polymeric fibers having a melting point higher than the leaflet material.

11 . The transcatheter prosthetic heart valve of claim 1 , wherein the leaflets are thermoformed into a predetermined stress-free shape based on optimization using finite element modeling.

12 . The transcatheter prosthetic heart valve of claim 1 , wherein the leaflet material comprises one or more of polyolefin, polycarbonate, polypropylene, polystyrene, acetal, acrylic, acrylonitrile butadiene styrene.

13 . The transcatheter prosthetic heart valve of claim 1 , wherein the geometry of the stent frame is determined based on optimizations of a top angle at posts of the stent frame and a bottom angle at nadirs of the stent frame using finite element modeling.

14 . The transcatheter prosthetic heart valve of claim 13 , wherein the top angle is between 0° and 20° and the bottom angle is between 0° and 40°.

15 . The transcatheter prosthetic heart valve of claim 1 , wherein the fibers are made of one or more materials selected from carbon fibers, ultra-high molecular weight polyethylene, P-phenylene-2, 6 benzobisoxazole, polyester, and aramid fibers.

16 . The transcatheter prosthetic heart valve of claim 1 , wherein the stress-concentrated lines are mapped using finite element modeling.

17 . The transcatheter prosthetic heart valve of claim 1 , wherein a diameter or characteristic width of each of the fibers is greater than 0 micrometer and less than 80 micrometers.

18 . The transcatheter prosthetic heart valve of claim 1 , wherein the one or more reinforcement components comprise a fiber reinforcement layer along commissures between the leaflets or along interleaflet regions.

19 . The transcatheter prosthetic heart valve of claim 18 , wherein the one or more reinforcement components comprise one or more welded fiber reinforcement layers on one or both sides of the fiber reinforcement layer.

20 . A transcatheter prosthetic heart valve, comprising:
a stent frame assembly comprising a top portion and a bottom portion; a leaflet material comprising:
a lower portion attached to the stent frame; and
an upper portion comprising leaflets that are capable of moving between an open configuration and a closed configuration, wherein at least a portion of the leaflet material weaves through the stent frame assembly; and
one or more reinforcement components coupled to the stent frame assembly and/or to the leaflet material to enhance performance of the transcatheter heart valve, wherein the one or more reinforcement components comprise one or more clamps or clips to hold the top portion and the bottom portion of the stent frame assembly together with the leaflet material anchored between the top portion and the bottom portion of the stent frame assembly.

Assignees

• Ohio State Innovation Foundation
• Georgia Institute Of Tech
• Univ Colorado State Res Found

Inventors

• Bui Hieu
• Dasi Lakshmi Prasad
• Heitkemper Megan
• James Susan
• Khair Nipa

Classifications

• A61F2240/001

  Designing or manufacturing processes · CPC title

• A61F2210/0004

  bioabsorbable · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title