Stent loading tool and method for use thereof

• US 10,188,516 B2
• Filed: 06/15/2016
• Issued: 01/29/2019
• 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, Raphael, Ezekiel, Guy
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US15/183,208
• Publication Number:
  US 20160361167A1
• Time in Patent Office: 958 Days
• 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 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 loading system for loading a valve prosthesis into a delivery catheter, the loading system comprising:

a loading tool comprising a loading tool connection member, wherein the loading tool connection member comprises a first plurality of prongs, wherein the loading tool connection member includes an open state with the first plurality of prongs flared outwardly and a closed state with the first plurality of prongs radially contracted;

a valve prosthesis including a radially compressed configuration and a radially expanded configuration, the valve prosthesis comprising valve prosthesis connection members configured to removably engage with a respective one of the first plurality of prongs, wherein the loading tool is configured to engage the valve prosthesis with the valve prosthesis in the radially expanded configuration and the loading tool in the open state; and

a crimping tool comprising a proximal end and a distal end, wherein the diameter of the distal end is greater than the diameter of the proximal end,

wherein the loading tool connection member, in the open state while engaged with the valve prosthesis in the radially expanded configuration, is configured to pass through the crimping tool such that the valve prosthesis crimps from the radially expanded configuration to the radially compressed configuration and the loading tool connection member radially contracts from the open state to the closed state.

2. The loading system of claim 1, wherein the loading tool is configured to automatically disengage from the valve prosthesis when the valve prosthesis is unloaded from a delivery catheter.

3. The loading system of claim 1, wherein the loading tool further comprises a pusher connector disposed opposite the loading tool connection member, wherein the pusher connector is configured for attachment to an inner shaft of the delivery catheter.

4. The loading system of claim 3, wherein the loading tool further comprises a detachable handle configured for attachment to the pusher connector during crimping of the valve prosthesis, wherein the detachable handle is configured for detachment from pusher connector after crimping of the valve prosthesis such that the pusher connector can be attached to the inner shaft of the delivery catheter.

5. The loading system of claim 1, further comprising a storage container for the valve prosthesis, wherein the loading tool and the crimping tool are provided separately from the storage container for valve prosthesis.

6. The loading system of claim 1, wherein each of the first plurality of prongs includes a radially outwardly facing notch, and wherein the valve prosthesis connection members are configured to be inserted into a respective radially outwardly facing notch.

7. The loading system of claim 1, wherein each of the first plurality of prongs includes a radially outwardly facing hook member, and wherein the valve prosthesis connection members each includes an aperture such that each outwardly facing hook member of the first plurality of prongs is configured to be inserted into the aperture of a corresponding one of the valve prosthesis connection members.

8. The loading system of claim 1, wherein the loading tool comprises a second plurality of prongs that are shorter than the first plurality of prongs, each prong of the second plurality of prongs being disposed circumferentially between a pair of prongs of the first plurality of prongs.

9. The loading system of claim 8, wherein the proximal end of the crimping tool includes an inner surface including an indentation, and wherein the indentation is configured to interact with at least one of the second plurality of prongs to prevent the loading tool from advancing distally through the crimping tool after the at least one of the second plurality of prongs is advanced proximally through the crimping tool such that the at least one of the second plurality of prongs is proximal of the indentation.

10. The loading system of claim 1, wherein the proximal end of the crimping tool includes an inner surface including an indentation, and wherein the indentation is configured to interact with at least one of the first plurality of prongs to prevent the loading tool from advancing distally through the crimping tool after the at least one of the first plurality of prongs is advanced proximally through the crimping tool such that the at least one of the first plurality of prongs is proximal of the indentation.

11. A kit comprising:

a loading tool comprising a loading tool connection member, wherein the loading tool connection member comprises a first plurality of prongs, wherein the loading tool connection member includes an open state with the first plurality of prongs flared outwardly and a closed state with the first plurality of prongs radially contracted;

a valve prosthesis including a radially compressed configuration and a radially expanded configuration, the valve prosthesis comprising valve prosthesis connection members configured to removably engage with a respective one of the first plurality of prongs, wherein the loading tool is configured to engage the valve prosthesis with the valve prosthesis in the radially expanded configuration and the loading tool in the open state;

a crimping tool comprising a proximal end and a distal end, wherein the diameter of the distal end is greater than the diameter of the proximal end; and

an openable container surrounding the valve prosthesis, the loading tool, and the crimping tool;

wherein the loading tool connection member, in the open state while engaged with the valve prosthesis in the radially expanded configuration, is configured to pass through the crimping tool such that the valve prosthesis crimps from the radially expanded configuration to the radially compressed configuration and the loading tool connection member radially contracts from the open state to the closed state.

12. The kit of claim 11, wherein the loading tool is configured to automatically disengage from the valve prosthesis when the valve prosthesis is unloaded from a delivery catheter.

13. The kit of claim 11, wherein the loading tool further comprises a pusher connector disposed opposite the loading tool connection member, wherein the pusher connector is configured for attachment to an inner shaft of a delivery catheter.

14. The kit of claim 13, wherein the loading tool further comprises a detachable handle configured for attachment to the pusher connector during crimping of the valve prosthesis, wherein the detachable handle is configured for detachment from pusher connector after crimping of the valve prosthesis such that the pusher connector can be attached to the inner shaft of the delivery catheter.

15. The kit of claim 11, wherein each of the first plurality of prongs includes a radially outwardly facing notch, and wherein the valve prosthesis connection members are configured to be inserted into a respective radially outwardly facing notch.

16. The kit of claim 11, wherein each of the first plurality of prongs includes a radially outwardly facing hook member, and wherein the valve prosthesis connection members each includes an aperture such that each outwardly facing hook member of the first plurality of prongs is configured to be inserted the aperture of a corresponding one of the valve prosthesis connection members.

17. The kit of claim 11, wherein the loading tool comprises a second plurality of prongs that are shorter than the first plurality of prongs, each prong of the second plurality of prongs being disposed circumferentially between a pair of prongs of the first plurality of prongs.

18. The loading system of claim 17, wherein the proximal end of the crimping tool includes an inner surface including an indentation, and wherein the indentation is configured to interact with at least one of the second plurality of prongs to prevent the loading tool from advancing distally through the crimping tool after the at least one of the second plurality of prongs is advanced proximally through the crimping tool such that the at least one of the second plurality of prongs is proximal of the indentation.