STENT LOADING TOOL AND METHOD FOR USE THEREOF

• US 20090054976A1
• Filed: 08/20/2007
• Published: 02/26/2009
• 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: Kilemnik, Ido, Kovalsky, Igor, Ezekiel, Guy, Benary, Rafhael, Sudin, Yuri, Tuval, Yosi
• Granted Patent: US 8,747,458 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for facilitating pushing of the stent-mounted valve from the delivery catheter into a native heart valve orifice, the loading tool comprising

at least one connector adapted for being removably connected to the stent of the stent-mounted valve and for disconnecting from the stent of the stent valve upon delivery of the stent valve into a native heart valve orifice.

2. The tool of claim 1 wherein the at least one connector comprises at least one prong.

3. The tool of claim 1 wherein the at least one connector comprises three prongs.

4. The tool of claim 1 wherein the loading tool has a longitudinal axis and the at least one connector is configured to removably attach to the stent of the stent valve upon radial compression of the at least one connector with respect to the longitudinal axis and concurrent radial crimping of the stent of the stent valve.

5. The tool of claim 1 further comprising a pusher connector opposite the at least one connector, the pusher connector configured to attach to a inner shaft for pushing the loading tool and the stent-mounted valve through a catheter and into a native heart valve orifice.

6. A delivery assembly for implanting a stent-mounted valve into a native heart valve orifice comprising:

stent-mounted valve comprising a stent and a valve, attachable to a loading tool, and

the loading tool comprising at least one connector configured to removably attach to the stent of the stent-mounted valve and to become non-attached from the stent of the stent valve upon delivery of the valve into a native heart valve orifice.

7. The delivery assembly of claim 6 wherein the loading tool at least one connector is attached to the stent-mounted valve.

8. The delivery assembly of claim 7 wherein the loading tool is configured to automatically become non-attached to the stent-mounted valve upon delivery of the valve into a native heart valve orifice.

9. The delivery assembly of claim 6 wherein the at least one connector comprises at least one prong.

10. The delivery assembly of claim 6 wherein the at least one connector comprises three prongs.

11. The delivery assembly of claim 6 wherein the loading tool has a longitudinal axis and the at least one connector is configured to removably attach to the stent of the stent valve upon radial compression of the at least one connector with respect to the longitudinal axis and concurrent radial crimping of the stent of the stent valve.

12. The delivery assembly of claim 11 further comprising a crimping tool configured to radially compress the loading tool and stent valve.

13. The delivery assembly of claim 12 wherein the crimping tool substantially surrounds the loading tool and stent valve and includes a converging diameter inner surface.

14. The delivery assembly of claim 6 wherein the loading tool further comprises a pusher connector opposite the at least one connector, the pusher connector configured to attach to a inner shaft for pushing the loading tool and the stent-mounted valve through a delivery catheter and into a native heart valve orifice.

15. The delivery assembly of claim 13 the loading tool further comprises a pusher connector opposite the at least one connector, the pusher connector configured to attach to a inner shaft for pushing the loading tool and the stent-mounted valve through a delivery catheter and into a native heart valve orifice.

16. The delivery assembly of claim 14 further comprising the inner shaft configured to push the loading tool and the stent-mounted valve through a delivery catheter and into a native heart valve orifice.

17. The delivery assembly of claim 16 further comprising the delivery catheter having a lumen and configured to allow the inner shaft to push the loading tool and the stent-mounted valve through the catheter lumen and into a native heart valve orifice.

18. The delivery assembly of claim 14 further comprising a removable handle attached to the pusher connector.

19. The delivery assembly of claim 6 further comprising an openable container surrounding the stent-mounted valve.

20. The delivery assembly of claim 7 further comprising an openable container surrounding the stent-mounted valve and the loading tool.

21. The delivery assembly of claim 13 further comprising an openable container surrounding the stent-mounted valve, loading tool, and crimping device.

22. A system for loading a stent-mounted valve into a delivery catheter for performance of a transcatheter procedure, the system comprising;

a) a loading tool comprising at least one connector adapted for being removably connected to the stent of a stent-mounted valve, wherein said loading tool is adapted for being coupled to a inner shaft of a delivery catheter, and;

b) a crimping tool having a generally converging shape;

wherein 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 the delivery catheter via coupling of the loading tool to the delivery catheter.

23. The system of claim 22 wherein the loading tool further comprises a handle adapted for being detached from the loading tool after crimping of the stent-mounted valve, and prior to attachment of the loading tool to the delivery catheter.

24. The system of claim 22 wherein the at least one connector comprises a prong.

25. The system of claim 22 wherein the at least one connector comprises three prongs.

26. The system of claim 25 wherein the stent comprises a plurality of connecting members for facilitating connection to the prongs of the loading tool.

27. The system of claim 26 wherein each of the prongs comprises a notch for facilitating connection to the connecting members of the stent.

28. The system of claim 25 wherein each of the prongs comprises a hook-shaped member for facilitating connection to the connecting members of the stent.

29. The system of claim 22 wherein the stent-mounted valve, the loading tool, and the crimping tool are provided to the user as a single unit inside of a storage container.

30. The system of claim 22 wherein the loading tool and the crimping tool are provided separately from the stent-mounted valve.

31. 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 the steps of;

(a) providing a stent-mounted valve in a substantially open state inside of a storage container;

(b) providing a loading tool comprising at least one connector adapted for being removably connected to the stent-mounted valve, and further adapted for being coupled to a inner shaft of a delivery catheter;

(c) providing a generally converging-shape crimping tool;

(d) attaching the loading tool to the stent-mounted valve using the at least one connector;

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

(f) advancing the stent-mounted valve through the crimping tool using the loading tool such that the stent-mounted valve becomes crimped;

(g) coupling the loading tool to the inner shaft of the delivery catheter, and;

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

32. The method of claim 31 wherein the step of attaching the loading tool to the stent-mounted valve using the at least one connector comprises providing the stent-mounted valve connected to the loading tool inside of the converging-shape crimping tool inside of a storage container.

33. The method of claim 31 further comprising a step of washing the stent-mounted valve.

34. The method of claim 31 wherein the step of providing a stent-mounted valve comprises providing a stent-mounted valve is adapted for being automatically disconnected from the loading tool upon release and expansion of the stent-mounted valve within a native heart valve orifice.

35. The method of claim 31 wherein the step of providing the loading tool comprises providing a loading tool wherein the at least one connector comprises a prong.

36. The method of claim 31 wherein the step of providing the loading tool comprises providing a loading tool wherein the at least one connector comprises three prongs.

37. The method of claim 31 wherein the step of providing the loading tool comprises providing a loading tool further comprising a detachable handle adapted for being detached from the loading tool after crimping of the stent-mounted valve, and prior to coupling of the loading tool to the delivery catheter.

38. A kit for implanting a stent-mounted valve into a native heart valve orifice comprising:

a stent-mounted valve comprising a stent and a valve, attachable to a loading tool,

the loading tool comprising at least one connector removably attached to the stent of the stent-mounted valve and configured to become non-attached from the stent of the stent valve upon delivery of the valve into a native heart valve orifice,

a crimping tool having a converging diameter inner surface substantially surrounding the loading tool and stent valve and configured to radially compress the loading tool and stent valve, and

an openable container surrounding the stent-mounted valve, loading tool, and crimping device.

39. The kit of claim 38 wherein the loading tool is configured to automatically become non-attached to the to the stent-mounted valve upon delivery of the valve into a native heart valve orifice.

40. The kit of claim 38 wherein the at least one connector comprises at least one prong.

41. The kit of claim 38 wherein the at least one connector comprises three prongs.

42. The kit of claim 38 wherein the loading tool has a longitudinal axis and the at least one connector is configured to removably attach to the stent of the stent valve upon radial compression of the at least one connector with respect to the longitudinal axis and concurrent radial crimping of the stent of the stent valve.

43. The kit of claim 38 wherein the loading tool further comprises a pusher connector opposite the at least one connector, the pusher connector configured to attach to a inner shaft for pushing the loading tool and the stent-mounted valve through a delivery catheter and into a native heart valve orifice.

44. The kit of claim 43 further comprising the inner shaft configured to push the loading tool and the stent-mounted valve through a delivery catheter and into a native heart valve orifice.

45. The kit of claim 44 further comprising the delivery catheter having a lumen and configured to allow the inner shaft to push the loading tool and the stent-mounted valve through the catheter lumen and into a native heart valve orifice.

46. The kit of claim 43 further comprising a removable handle attached to the pusher connector.