Stent loading tool and method for use thereof

• US 9,393,112 B2
• Filed: 02/27/2014
• Issued: 07/19/2016
• Est. Priority Date: 08/20/2007
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Sudin, Yuri, Kilemnik, Ido, Kovalsky, Igor, Benary, Rafhael, Ezekiel, Guy
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US14/192,614
• Publication Number:
  US 20140230515A1
• Time in Patent Office: 873 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the stent-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in a crimped state, into a delivery catheter. Also disclosed is a kit of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

Claims

1. A method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure, the method comprising:

attaching a loading tool to a substantially open state stent-mounted valve inside a storage container using a connector of the loading tool in an open state, wherein the connector is configured to be removably connected to the stent-mounted valve, and wherein the loading tool is configured to be coupled to an inner shaft of a delivery catheter;

withdrawing the stent-mounted valve from the storage container using the loading tool;

advancing the stent-mounted valve and the connector of the loading tool through a generally converging-shape crimping tool using the loading tool such that the stent-mounted valve becomes crimped and the connector of the loading tool radially contracts from the open state to a closed state;

coupling the loading tool to the inner shaft of the delivery catheter; and

retracting the stent-mounted valve and the loading tool into the delivery catheter.

2. The method of claim 1, wherein during the attaching the loading tool to the substantially open state stent-mounted valve, the stent-mounted valve is inside the converging-shape crimping tool, and the converging-shape crimping tool is inside the storage container.

3. The method of claim 1, further comprising washing the stent-mounted valve.

4. The method of claim 1, wherein the stent-mounted valve is configured to be automatically disconnected from the loading tool upon release and expansion of the stent-mounted valve within a native heart valve orifice.

5. The method of claim 1, wherein the connector comprises a prong.

6. The method of claim 1, wherein the connector comprises three prongs.

7. The method of claim 1, wherein the loading tool further comprises a detachable handle configured to be detached from the loading tool after crimping of the stent-mounted valve, and before coupling of the loading tool to the delivery catheter.

8. The method of claim 1, wherein the connector comprises a plurality of prongs, wherein in the open state distal ends of the plurality of prongs are spread apart from each other, and when the connector is advanced through the generally converging-shape crimping tool the distal ends of the plurality of prongs move towards each other.

9. The method of claim 8, wherein each of the plurality of prongs includes a radially outwardly facing notch, and wherein the step of attaching the loading tool to the stent-mounted valve comprises inserting stent connectors of the stent-mounted valve into each radially outwardly facing notch.

10. The method of claim 8, wherein each of the plurality of prongs includes a radially outwardly facing hook member, and wherein the stent-mounted valve includes a plurality of stent connectors with each stent connector including an aperture, and wherein the step of attaching the loading tool to the stent-mounted valve comprises inserting each hook member into a corresponding aperture of one of the plurality of stent connectors.

11. The method of claim 1,

wherein the connector comprises a plurality of long prongs, wherein in the open state distal ends of the plurality of long prongs are spread apart from each other,

wherein when the connector is advanced through the generally converging-shape crimping tool the distal ends of the plurality of long prongs move towards each other,

wherein the loading tool comprises at least one short prong,

wherein a narrow neck of the crimping tool includes at least an indentation, and

wherein when the loading tool is advanced through the crimping tool such that the at least one short prong is proximal of the indentation, interaction of the at least one short prong and the indentation prevents the loading tool from being advanced distally.

12. A method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure, the method comprising:

removably attaching a loading tool to a portion of a stent-mounted valve inside a storage container using a connector of the loading tool, wherein the stent-mounted valve including the portion to which the connector is removably attached is in a radially expanded configuration,

withdrawing the stent-mounted valve from the storage container using the loading tool;

advancing the stent-mounted valve through a generally converging-shape crimping tool using the loading tool such that the stent-mounted valve including the portion to which the connector is removably attached compresses into a radially collapsed configuration;

coupling the loading tool to an inner shaft of the delivery catheter; and

retracting the stent-mounted valve and the loading tool into the delivery catheter.

13. The method of claim 12, wherein the stent-mounted valve is configured to be automatically disconnected from the loading tool upon release and expansion of the stent-mounted valve within a native heart valve orifice.

14. The method of claim 12, wherein the connector comprises a prong.

15. The method of claim 12, wherein the connector comprises three prongs.

16. The method of claim 12, wherein the loading tool further comprises a detachable handle configured to be detached from the loading tool after crimping of the stent-mounted valve, and before coupling of the loading tool to the delivery catheter.

17. The method of claim 12, wherein the connector comprises a plurality of prongs, wherein the plurality of prongs are in an open state when the loading tool is removably attached to the portion of the stent-mounted valve, and wherein when stent-mounted valve is advanced through the generally converging-shape crimping tool the plurality of prongs move towards each other to a closed state.

18. The method of claim 17, wherein each of the plurality of prongs includes a radially outwardly facing notch, and wherein the step of removably attaching the loading tool to the stent-mounted valve comprises inserting stent connectors of the stent-mounted valve into each radially outwardly facing notch.

19. The method of claim 17, wherein each of the plurality of prongs includes a radially outwardly facing hook member, and wherein the stent-mounted valve includes a plurality of stent connectors with each stent connector including an aperture, and wherein the step of removable attaching the loading tool to the stent-mounted valve comprises inserting each hook member into a corresponding aperture of one of the plurality of stent connectors.