IP Library › Granted Patent US 12,427,019
Granted Patent B2
US 12,427,019 · App. 17/353,702 · Granted Sep 30, 2025

Apparatus and method for monitoring valve expansion

Inventors: Elazar Levi Schwarcz (Netanya, IL); Oren Cohen (Kadima, IL); Ofir Witzman (Kfar Saba, IL); Yair A. Neumann (Moshav Sede Varburg, IL); Noam Miller (Givatayim, IL); Ziv Yohanan (Kfar Hahoresh, IL)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2427A61F2/243A61F2002/9534A61F2250/0098
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Quick Facts
Patent No.
US 12,427,019
App. No.
17/353,702
Granted
Sep 30, 2025
Kind
B2
Abstract

Embodiments of a prosthetic valve delivery apparatus are disclosed. The delivery apparatus includes a first portion configured to maintain a fixed spatial relationship relative to a first end of the prosthetic valve and a second portion configured to maintain a fixed spatial relationship relative to a second end of the prosthetic valve during radial expansion of the prosthetic valve. The first portion includes one or more reference radiopaque markers and the second portion includes an indicator radiopaque marker. A position of the indicator radiopaque marker relative to the one or more reference radiopaque markers measures an axial distance between the first and second ends of the prosthetic valve indicative of a corresponding diameter of the prosthetic valve as it is radially expanded from a radially compressed state to a radially expanded state.

Claims (31)

1. A delivery apparatus configured to provide visual feedback of radial expansion of a prosthetic valve, the delivery apparatus comprising:

a first portion configured to maintain a fixed spatial relationship relative to a first end of the prosthetic valve and a second portion configured to maintain a fixed spatial relationship relative to a second end of the prosthetic valve during radial expansion of the prosthetic valve;

wherein the first portion comprises one or more reference radiopaque markers and the second portion comprises an indicator radiopaque marker, wherein axially moving the indicator radiopaque marker toward the one or more reference radiopaque markers or axially moving the one or more reference radiopaque markers toward the indicator radiopaque marker measures a reduction in an axial distance between the first and second ends of the prosthetic valve indicative of a corresponding increase in a diameter of the prosthetic valve as it is radially expanded from a radially compressed state to a radially expanded state.

2. The delivery apparatus of claim 1 , wherein the first portion is configured to be detachably connected to the prosthetic valve and the second portion is configured to move axially relative to the first portion as the prosthetic valve is radially expanded from the radially compressed state to the radially expanded state.

3. The delivery apparatus of claim 1 , wherein the second portion is configured to be detachably connected to the prosthetic valve and the first portion is configured to move axially relative to the second portion as the prosthetic valve is radially expanded from the radially compressed state to the radially expanded state.

4. The delivery apparatus of claim 1 , wherein the reference and indicator radiopaque markers are configured to be positioned outside of a frame of the prosthetic valve.

5. The delivery apparatus of claim 1 , wherein the one or more reference radiopaque markers comprise a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker, and wherein while the prosthetic valve is expanded from the radially compressed state to the radially expanded state, alignment of the indicator radiopaque marker with the first reference radiopaque marker indicates a first expanded diameter of the prosthetic valve, and alignment of the indicator radiopaque marker with the second reference radiopaque marker indicates a second expanded diameter of the prosthetic valve.

6. The delivery apparatus of claim 1 , wherein the first portion and the second portion are configured to interface with an expansion mechanism of the prosthetic valve such that relative movement between the first and second portions in a first direction causes the prosthetic valve to expand from the radially compressed state to the radially expanded state, and relative movement between the first and second portions in a second direction opposite the first direction causes the prosthetic valve to compress from the radially expanded state to the radially compressed state.

7. The delivery apparatus of claim 6 , wherein the expansion mechanism comprises a locking mechanism configured to lock the prosthetic valve in a fixed diameter, wherein the locking mechanism is actuated when a locking member is moved to a locking position by the first or second portion.

8. The delivery apparatus of claim 7 , wherein at least one of the indicator and reference radiopaque markers is configured to align with a radiopaque portion of the prosthetic valve when the locking member is moved to the locking position.

9. A prosthetic valve delivery assembly comprising:

a prosthetic valve having an inflow end and an outflow end; and

a delivery apparatus comprising a first portion and a second portion;

wherein the second portion is configured to move axially relative to the first portion or the first portion is configured to move axially relative to the second portion as the prosthetic valve is radially expanded from a radially compressed state to a radially expanded state;

wherein the first portion comprises one or more reference radiopaque marker and the second portion comprises an indicator radiopaque marker, wherein axially moving the indicator radiopaque marker toward the one or more reference radiopaque markers or axially moving the one or more reference radiopaque markers toward the indicator radiopaque marker measures a reduction in an axial length of the prosthetic valve indicative of a corresponding increase in a diameter of the prosthetic valve.

10. The assembly of claim 9 , wherein the first portion maintains a fixed spatial relationship relative to the outflow end and the second portion maintains a fixed spatial relationship relative to the inflow end during radial expansion of the prosthetic valve.

11. The assembly of claim 9 , wherein the first portion maintains a fixed spatial relationship relative to the inflow end and the second portion maintains a fixed spatial relationship relative to the outflow end during radial expansion of the prosthetic valve.

12. The assembly of claim 9 , wherein the prosthetic valve comprises a valve expansion mechanism, the valve expansion mechanism comprising an inner member received at least partially within an outer member, wherein axial movement of the inner member relative to the outer member causes radial expansion or compression of the prosthetic valve.

13. The assembly of claim 12 , wherein the first portion is configured to be connected to the outer member and the second portion is configured to be connected to the inner member such that retracting the second portion axially relative to the first portion causes axial movement of the inner member relative to the outer member.

14. The assembly of claim 9 , wherein the reference and indicator radiopaque markers are configured to be positioned outside of a frame of the prosthetic valve such that the reference and indicator radiopaque markers are visible under fluoroscopy during radial expansion of the prosthetic valve.

15. The assembly of claim 9 , wherein the at least one reference radiopaque marker comprises a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker, and wherein while the prosthetic valve is expanded from the radially compressed state to the radially expanded state, alignment of the indicator radiopaque marker with the first reference radiopaque marker indicates a first expanded diameter of the prosthetic valve, and alignment of the indicator radiopaque marker with the second reference radiopaque marker indicates a second expanded diameter of the prosthetic valve.

16. A prosthetic valve delivery assembly comprising:

a prosthetic valve having an inflow end and an outflow end; and

a delivery apparatus comprising a first portion and a second portion;

wherein the second portion is configured to move axially relative to the first portion as the prosthetic valve is radially expanded from a radially compressed state to a radially expanded state;

wherein the first portion comprises one or more reference radiopaque markers and the second portion comprises an indicator radiopaque marker, wherein a position of the indicator radiopaque marker relative to the one or more reference radiopaque markers measures an axial length of the prosthetic valve indicative of a corresponding diameter of the prosthetic valve,

wherein the prosthetic valve comprises a valve expansion mechanism, the valve expansion mechanism comprising an inner member received at least partially within an outer member, wherein axial movement of the inner member relative to the outer member causes radial expansion or compression of the prosthetic valve.

17. The prosthetic valve delivery assembly of claim 16 , wherein the first portion is configured to be connected to the outer member and the second portion is configured to be connected to the inner member such that retracting the second portion axially relative to the first portion causes axial movement of the inner member relative to the outer member.

18. The prosthetic valve delivery assembly of claim 16 , wherein the reference and indicator radiopaque markers are configured to be positioned outside of a frame of the prosthetic valve such that the reference and indicator radiopaque markers are visible under fluoroscopy during radial expansion of the prosthetic valve.

19. The prosthetic valve delivery assembly of claim 16 , wherein the first portion maintains a fixed spatial relationship relative to the outflow end and the second portion maintains a fixed spatial relationship relative to the inflow end during radial expansion of the prosthetic valve.

20. The prosthetic valve delivery assembly of claim 16 , wherein the first portion maintains a fixed spatial relationship relative to the inflow end and the second portion maintains a fixed spatial relationship relative to the outflow end during radial expansion of the prosthetic valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2021
From: SCHWARCZ, ELAZAR LEVI; COHEN, OREN; WITZMAN, OFIR; NEUMANN, YAIR A.; MILLER, NOAM; YOHANAN, ZIV
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 057262/0540 →
Continuity (3)
Continuation PCTUS2020013429 · Jan 14, 2020
Provisional Application 62793116 · Jan 16, 2019
Related Publication 20210307904A1 · Oct 7, 2021
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