Transcatheter heart valve storage container and crimping mechanism

Patent metadata

Field	Value
Publication number	US-12370035-B2
Application number	US-202318094864-A
Country	US
Kind code	B2
Filing date	Jan 9, 2023
Priority date	Jul 18, 2017
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

First claim

What is claimed is:

1. A storage container for a medical device, comprising:
a container housing;
a top cover rotatably coupled to the container housing, the top cover including a central threaded opening;
a valve cover fixedly coupled to the container housing between the top cover and the container housing, the valve cover including a first, central, opening in communication with an interior of the container housing and axially aligned with the threaded opening of the top cover; and
a base received within the container housing and including an arm extending through a second opening in the valve cover, the arm including an exterior thread that engages the central threaded opening of the top cover,
wherein, upon rotation of the top cover, the exterior thread of the arm engages the threaded opening of the top cover causing the base to move axially with respect to valve cover.

2. The storage container of claim 1 , wherein the top cover includes a lower flange extending from a bottom surface of the top cover, the lower flange extending around a housing shoulder projecting from the housing, wherein the lower flange axially fixes the container housing, valve cover, and top cover.

3. The storage container of claim 2 , wherein the lower flange defines a recess sized and configured to receive the housing shoulder and an edge of the valve cover.

4. The storage container of claim 3 , wherein the housing shoulder projects radially from a sidewall of the housing, where the housing shoulder is received within the recess defined by the lower flange such that the top cover is rotatably coupled to the container housing and the valve cover.

5. The storage container of claim 1 , wherein the base includes a central cavity sized and configured to receive a heart valve in an expanded configuration.

6. The storage container of claim 5 , wherein rotation of the top cover moves a heart valve through the central opening of the valve cover, thereby converting the heart valve from the expanded configuration to a crimped configuration as it exits the container housing.

7. The storage container of claim 6 , wherein movement of a heart valve through the central opening converts the heart valve from its expanded configuration to its crimped configuration.

8. The storage container of claim 1 , wherein the valve cover includes a tapered channel extending from a bottom surface to the central opening of the valve cover, and
wherein movement of a heart valve through the tapered channel converts a heart valve from an expanded configuration to a crimped configuration.

9. The storage container of claim 8 , wherein the tapered channel defines a cone-shaped passage.

10. The storage container of claim 8 , wherein a size of an opening to the tapered channel at the bottom surface corresponds to the size of a heart valve in its expanded configuration.

11. The storage container of claim 1 wherein the arm extends from an end surface of the base, the arm having a semi-circular shape in cross section.

12. The storage container of claim 1 , wherein the storage container further includes a valve stage located within a central cavity of the base, the valve stage configured to provide axial support for a heart valve,
wherein the valve stage is provided adjacent an end surface of the base.

13. The storage container of claim 1 , wherein the storage container further includes a valve support including a base structure and an arm extending from the base structure, the arm configured to extend axially adjacent a heart valve and to provide radial or lateral support for a heart valve.

14. The storage container of claim 13 , wherein the valve support is provided between the container housing and the base,
wherein the valve support is fixed axially within the container housing during movement of the based with respect to the valve cover,
wherein movement of the base toward the valve cover causes a portion of the arm of the valve support to extend through an opening provided in the end surface of the base.

15. A system for storing and crimping an expandable prosthetic heart valve, comprising:
an expandable prosthetic heart valve having both crimped and expanded configurations, the heart valve comprising an annular frame with a leaflet structure positioned within frame,
a container housing sized and configured to receive the heart valve in its expanded configuration;
a crimping mechanism incorporated into the container housing and engaging the heart valve that is operable to convert the heart valve from its expanded configuration to its crimped configuration as it exits the container housing, the crimping mechanism including:
a top cover rotatably coupled to the container housing, the top cover including a central threaded opening;
a valve cover fixedly coupled to the container housing between the top cover and the container housing, the valve cover including a first, central, opening in communication with an interior of the container housing and axially aligned with the threaded opening of the top cover; and
a base received within the container housing and including an arm extending through a second opening in the valve cover, the arm including an exterior thread that engages the central threaded opening of the top cover,
wherein, upon rotation of the top cover, the exterior thread of the arm engages the threaded opening of the top cover causing the base to move axially with respect to valve cover.

16. The system of claim 15 , wherein the valve cover includes a tapered channel extending from a bottom surface of the valve cover to the central opening of the valve cover, and
wherein movement of the heart valve through the tapered channel converts the heart valve from its expanded configuration to its crimped configuration.

17. The system of claim 15 , wherein an outer surface of the container housing includes a radially projecting shoulder that is received within a corresponding recess provided in the top cover such that the top cover is rotatably coupled to the valve cover and the container housing.

18. The system of claim 15 , wherein the base includes an end surface and an arm extending from the end surface, the arm having a semi-circular shape in cross section,
wherein movement of the base towards the valve cover causes a portion of the arm to extend through an opening provided in the valve cover,
wherein rotation of the top cover causes the threaded opening of the top cover to move the arm axially through the opening in the valve cover.

19. The storage container of claim 15 , wherein the crimping mechanism further includes:
a valve stage located within a central cavity of the base, the valve stage configured to provide axial support for a heart valve, the valve stage is provided adjacent the end surface of the base, and
a valve support including a base structure and an arm extending from the base structure, the arm configured to extend axially adjacent a heart valve and to provide radial or lateral support for a heart valve, the valve support being provided between the container housing and the base,
wherein movement of the base toward the valve cover causes a portion of the arm of the valve support to extend through an opening provided in the end surface of the base.

20. A method of storing and crimping an expandable prosthetic heart valve, the method comprising:
providing a prosthetic heart valve having a crimped configuration sized to be delivered to a site of implantation through a catheter and an expanded configuration sized to engage a heart val

Assignees

• Edwards Lifesciences Corp

Inventors

• Nir Noam
• Peleg Carmel
• Saar Tomer
• Barash Alexander
• Maimon David

Classifications

• A61F2/9525

  using a funnel · CPC title

• A61F2/9524

  Iris-type crimpers · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title