DEVICES AND METHODS FOR CRIMPING A MEDICAL DEVICE

• US 20140331475A1
• Filed: 05/08/2014
• Published: 11/13/2014
• Est. Priority Date: 05/13/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Duffy, Niall, Haarstad, Philip, Harewood, Frank, Kovalsky, Igor, Quill, Jason, Gelfman, Daniel, Gokaldas, Shyam, Creaven, Marian, Menk, Ana, Janzig, Darren, Warnock, Kenneth
• Granted Patent: US 10,188,515 B2
• Time in Patent Office: Days
• US Class Current: 29/446
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: B23P 11/005 by expanding or crimping
• CPC Class Codes: Y10T 29/49863 with prestressing of part
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule

Abstract

Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Claims

1. A system for crimping a prosthetic valve comprising:

a first funnel, the first funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter;

a second funnel, the second funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter;

a delivery device, the delivery device comprising a strut support and an outer sheath, at least a portion of the delivery device configured to extend through the first funnel and the second funnel; and

an actuator, the actuator configured to attach to the prosthetic valve and pull the prosthetic valve through at least one of the first funnel and the second funnel;

wherein the first diameter of the first funnel is larger than the first diameter of the second funnel.

2. The system of claim 1, wherein the outer diameter of the outer sheath is less than or equal to the second diameter of the first funnel and the second diameter of the second funnel.

3. The system of claim 1, wherein the first funnel and the second funnel are releasably connected.

4. The system of claim 1, further comprising a barrel configured to connect the first funnel to the second funnel.

5. The system of claim 4, wherein the barrel comprises a first attachment portion for releasably engaging the first funnel.

6. The system of claim 1, wherein the actuator is a puller tube, the puller tube configured to extend through the first funnel and the second funnel.

7. The system of claim 1, wherein the actuator comprises a handle, a channel, and a pull ring.

8. The system of claim 7, wherein the actuator further comprises at least one wire operatively connected to the pull ring.

9. The system of claim 7, wherein the actuator is configured to engage to the second funnel.

10. The system of claim 7, wherein the actuator is configured to engage to the first diameter of the second funnel.

11. The system of claim 1, wherein the first funnel is configured to directly connect to the second funnel.

12. The system of claim 1, wherein the second diameter of the first funnel is configured to engage the second diameter of the second funnel.

13. The system of claim 1, further comprising a first tube releasably connected to the second diameter of the first funnel;

and

a second tube releasably connected to the second diameter of the second funnel

14. The system of claim 13, wherein the first diameter of the second funnel is configured to receive at least a portion of the first tube.

15. The system of claim 1, wherein the prosthetic valve is a self-expanding valve.

16. The system of claim 1, wherein the outer sheath is configured to slide over the strut support.

17. A device for crimping a prosthetic valve comprising:

a first funnel, the first funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter;

a second funnel, the second funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter;

an actuator, the actuator configured to attach to the prosthetic valve and pull the prosthetic valve through at least one of the first funnel and the second funnel;

wherein the first funnel and the second funnel are configured to releasably connect to each other; and

wherein the first diameter of the first funnel is larger than the first diameter of the second funnel.

18. The device of claim 17, further comprising a barrel, the barrel configured to connect to the first funnel and the second funnel.

19. The device of claim 18, wherein the barrel comprises a first attachment portion for releasably engaging the first funnel.

20. The device of claim 17, wherein the first funnel is configured to directly connect to the second funnel.

21. The device of claim 20, wherein the second diameter of the first funnel is configured to engage the second diameter of the second funnel.

22. The device of claim 17, further comprising a first tube releasably connected to the second diameter of the first funnel;

and

a second tube releasably connected to the second diameter of the second funnel

23. A method for crimping a prosthetic valve comprising:

attaching the prosthetic valve to an actuator;

advancing a first funnel over the prosthetic valve such that the prosthetic valve moves through the first funnel, the first funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter;

advancing a second funnel over the prosthetic valve such that the prosthetic valve moves into the second funnel and onto a strut support of a delivery device, the second funnel comprising a first diameter, a tapered section, and a second diameter smaller than the first diameter; and

advancing an outer sheath of the delivery device over the prosthetic valve on the strut support;

wherein the first diameter of the first funnel is larger than the first diameter of the second funnel.

24. The method of claim 23, wherein the actuator is a puller tube, the puller tube configured to extend through the first funnel and the second funnel.

25. The method of claim 23, wherein the first funnel and the second funnel configured to be releasably connected to a barrel.

26. The method of claim 25, further comprising:

attaching the barrel to the first funnel before advancing the first funnel over the prosthetic valve; and

advancing the prosthetic valve through the first funnel and into the barrel.

27. The method of claim 26, further comprising disconnecting the barrel from the first funnel after advancing the prosthetic valve into the barrel.

28. The method of claim 27, further comprising connecting the second funnel to the barrel before advancing the second funnel over the prosthetic valve.

29. The method of claim 23, wherein the actuator comprises a handle, a channel, and a pull ring.

30. The method of claim 29, wherein the actuator further comprises at least one wire operatively connected to the pull ring.

31. The method of claim 23, wherein the second diameter of the first funnel is configured to engage the second diameter of the second funnel.