Expandable frame for medical device

Patent metadata

Field	Value
Publication number	US-12383399-B2
Application number	US-202418602873-A
Country	US
Kind code	B2
Filing date	Mar 12, 2024
Priority date	May 31, 2022
Publication date	Aug 12, 2025
Grant date	Aug 12, 2025

Abstract

A prosthetic heart valve for the treatment of structural heart disease wherein the prosthetic heart valve includes an expandable frame that is formed of a rhenium containing metal alloy. The novel geometry of the expandable frame in combination with the frame being partially or fully formed of the rhenium containing alloy enables the formation of a frame that a) has an open cell geometry in the frame of the prosthetic heart valve that can be used to reduce delivery system size, b) has high radial strength, c) has improved restoration of the physiologic EOA, d) has lower recoil, e) has little or no longitudinal foreshortening, f) allows for proper placement of the bioprosthetic valve in relation to the native commissures of the valve, h) has symmetrical and cylindrical expansion of the prosthetic valve resulting in lower rates of leaflet thrombosis and structural valve deterioration, and i) prevents allergic response and restenosis associated with nickel content.

First claim

What is claimed:

1. An expandable prosthetic heart valve comprising an expandable metal frame and at least one leaflet that is connected to said expandable metal frame; said expandable metal frame is configured to be expanded from a crimped orientation to an expanded orientation in a body passageway; said expandable metal frame has distal and proximal ends; said expandable metal frame includes an open cell configuration that includes a plurality of stacked cell rows that are stacked along the longitudinal length of said expandable metal frame; each of said cell rows includes a plurality of frame cells; each of said cell rows has a same number of said frame cells; each of said cell rows includes first and second frame cells; each of said first and second frame cells in each of said cell rows includes a first axial longitudinal member and a second axial longitudinal member; each of said first and second longitudinal axial members extends along a longitudinal length of said expandable metal frame and first and second articulating members that are connected to said first and second axial longitudinal members; at least 80% of a longitudinal length of each said first and second axial longitudinal members in said first and second frame cells is oriented parallel to a central axis of said expandable metal frame when said expandable metal frame is in said crimped and expanded orientations; each of said first axial longitudinal members in said first frame cell in each of said cell rows includes one end that is connected to an end of another of said first axial longitudinal members of at least one of said first frame cells in a different cell row; each of said first axial longitudinal members in said second frame cell in each of said cell rows includes one end that is connected to an end of another of said first axial longitudinal members of at least one of said second frame cells in a different cell row; each of said first axial longitudinal members in said first and second frame cells has a continuous linear shape along at least 80% of said longitudinal length of said first axial longitudinal member; each of said second axial longitudinal members in said first frame cell in each of said cell rows includes one end that is connected to an end of another of said second axial longitudinal members of at least one of said first frame cells in a different cell row; each of said second axial longitudinal members in said second frame cell in each of said cell rows includes one end that is connected to an end of another of said second axial longitudinal members of at least one of said second frame cells in a different cell row; at least one of said second axial longitudinal members in said first and second frame cells has a continuous linear shape along at least 80% of said longitudinal length of said second axial longitudinal member; a top end of each set of connected together first axial longitudinal members defines a portion of said proximal end of said expandable metal frame; a bottom end set of each connected together first axial longitudinal members defines a portion of said proximal end of said expandable metal frame; a top end of a plurality of sets of connected together first axial longitudinal members defines a portion of said proximal end of said expandable metal frame; a bottom end of a plurality of sets of connected together first axial longitudinal members defines a portion of said proximal end of said expandable metal frame; a middle region of each of said first and second articulating members in each frame cell in said cell row that is located closest to said proximal end of said expandable metal frame is positioned below an upper end of said first and second axial longitudinal members when said expandable metal frame is in said crimped orientation; a middle region of each of said first and second articulating members in each frame cell in said cell row that is located closest to said distal end of said expandable metal frame is positioned above a lower end of said first and second axial longitudinal members when said expandable metal frame is in said crimped orientation; a majority or all of each of said first and second articulating members does not extend above said upper end of said first or second axial longitudinal members that terminate at said proximal end of said expandable metal frame when said expandable metal frame is in said unexpanded crimped orientation and below said lower end of said first and second axial longitudinal members that terminate at said distal end of said expandable metal frame when said expandable metal frame is in said unexpanded crimped orientation; said expandable metal frame has a longitudinal foreshortening of no more than 5% along said longitudinal length of said expandable metal frame when expanded from said crimped orientation to said expanded orientation; said expandable metal frame has four or more properties selected from the group consisting of i) at least 70-100% of said expandable metal frame is formed of a metal alloy that has a yield strength of at least 110 ksi, ii) at least 70-100% of said expandable metal frame is formed of a metal alloy that has a modulus of elasticity of at least 35000 ksi, iii) said expandable frame has a frame geometry that has a maximum of nine of said frame cells in each of said cell rows, iv) at least 70-100% of said expandable metal frame is formed of a rhenium containing metal alloy that includes at least 15 awt. % rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, v) each of said first and second angular articulating members includes a plurality of arcuate portions along a longitudinal length of said first and second angular articulating members and vi) an outer surface of said expandable frame includes an enhancement layer; said enhancement layer includes one or more of chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium nitride oxide (TiNO x ), zirconium nitride (ZrN), zirconium oxide (ZrO 2 ), zirconium-nitrogen-carbon (ZrNC), zirconium OxyCarbide (ZrOC), and zirconium oxynitride (ZrN x O y ).

2. The expandable prosthetic heart valve as defined in claim 1 , wherein each of said first and second axial longitudinal members of said first and second frame cells in each of said cell rows has a continuous linear shape along at least 90% of said longitudinal length of said first and second axial longitudinal members; each of said first and second axial longitudinal members of said first and second frame cells in each of said cell rows are spaced from one another and are positioned parallel to one another when said expandable frame is in said crimped orientation.

3. The expandable prosthetic heart valve as defined in claim 1 , wherein said expandable metal frame consists of a) two cell rows, and wherein each of said cell rows includes the same number of said frame cells, and wherein a number of said frame cells in each of said cell rows is no more than nine, b) three cell rows, and wherein each of said cell rows includes the same number of said frame cells, and wherein a number of said frame cells in each row is no more than nine, or c) four cell rows, and wherein each of said cell rows includes the same number of said frame cells, and wherein a number of said frame cells in each of said cell rows is no more than nine.

4. The expandable prosthetic heart valve as defined in claim 1 , wherein said longitudinal length of said expandable metal frame is equivalent to a sum of a total longitudinal length of said first axial longitudinal members in said first frame cells when said expandable metal frame is in said crimped orientation.

5. The expandable prosthetic heart valve as defined in claim 1 , wherein a longitudinal length between said proximal end of said expandable metal frame and a commissural at

Assignees

• Mirus Llc

Inventors

• Panter Alex
• Yadav Jay
• Roth Noah

Classifications

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2310/00059

  Chromium or Cr-based alloys · CPC title

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61L27/38

  containing added animal cells (organs or tissue containing native cells A61L27/36) · CPC title

• A61L27/06

  Titanium or titanium alloys · CPC title