System and method for crimping a prosthetic valve

• US 8,652,145 B2
• Filed: 12/14/2012
• Issued: 02/18/2014
• Est. Priority Date: 12/14/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Maimon, David, Sharoni, Ron, Levi, Tamir S., Karapetian, Emil, Tran, Tri D., Le, Tung
• Primary Examiner(s): Jones, David B
• Application Number:
  US13/715,605
• Publication Number:
  US 20130152659A1
• Time in Patent Office: 431 Days
• Field of Search: 724/02, 724/091.9, 724/821, 292/19, 292/37, 292/82, 292/835, 294/47, 295/15, 295/16, 606/1, 606/108, 606/198
• US Class Current: 606/108
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B21D 41/00 Application of procedures in order to alter the diameter of tube ends B21D39/00 takes precedence ; plastic tubes B29C57/08
• CPC Class Codes: B21D 41/04 Reducing; Closing
• CPC Class Codes: B23P 11/00 Connecting or disconnecting metal parts or objects by metal-working techniques not otherwise provided for connecting sheet metal or metal tubes, rods or profiles B21D39/00; riveting B21J; soldering, unsoldering, welding B23K; hand tools for connecting wire or strip B25B25/00; connecting metal parts by adhesives F16B11/00
• CPC Class Codes: B23P 11/005 by expanding or crimping
• CPC Class Codes: B23P 19/04 for assembling or disassembling parts
• CPC Class Codes: B25B 27/10 inserting fittings into hoses
• CPC Class Codes: B30B 7/04 wherein pressing is effected in different directions simultaneously or in turn
• CPC Class Codes: Y10T 29/53552 Valve applying or removing
• CPC Class Codes: Y10T 29/53578 Lever operated
• CPC Class Codes: Y10T 29/5367 Coupling to conduit

Abstract

An exemplary system for crimping a prosthetic valve comprises a radially expandable and compressible prosthetic valve, a crimping device positioned around the valve and configured to reduce the diameter of the valve to a delivery configuration, and a sterile package enclosing the valve and the crimping device. The valve can be pre-assembled in a partially crimped configuration within the crimping device. After removing the sterile packaging, the crimping device can be used to crimp the valve from the partially crimped configuration to the delivery configuration, such as by twisting a knob on the crimping device. The system can further comprise at least a portion of a delivery catheter within the sterile package, wherein the valve is pre-mounted on or adjacent to an inflatable balloon of the delivery catheter, such that the valve can be crimped onto the delivery catheter using the crimping device.

Claims

1. A system comprising:

a radially expandable and compressible prosthetic valve;

a crimping device positioned around the valve, the crimping device being configured to reduce the diameter of the valve to a delivery configuration; and

a sterile package enclosing the valve and the crimping device.

2. The system of claim 1, wherein the valve is pre-assembled in a partially crimped configuration within the crimping device and within the sterile package.

3. The system of claim 2, wherein the crimping device is configured to crimp the valve from the partially crimped configuration to the delivery configuration.

4. The system of claim 1, further comprising at least a portion of a delivery catheter within the sterile package, wherein the valve is pre-mounted on or adjacent a balloon of the delivery catheter.

5. The system of claim 1, wherein the crimping device comprises:

a radially compressible collet positioned around the valve; and

a rotatable knob coupled to the collet, wherein rotation of the knob causes radial compression of the collet and crimping of the valve.

6. The system of claim 1, wherein the crimping device comprises means for releasably gripping a shaft of a delivery catheter.

7. The system of claim 1, further comprising a loader coupled to an end of the crimping device within the sterile package, the loader being configured to receive the valve, in the delivery configuration, from the crimping device.

8. The system of claim 1, wherein the crimping device comprises a coiled wire frame positioned around the prosthetic valve, a first end of the wire frame being coupled to a first member of the crimping device and a second end of the wire frame being coupled to a second member of the crimping device, wherein rotation of a screw moves the second member relative to the first member thereby decreasing the diameter of the coiled wire frame and thereby crimping the prosthetic valve positioned within the coiled wire frame.

9. The system of claim 1, wherein the valve is sealed within the sterile package in a wet state.

10. The system of claim 1, wherein the valve is sealed within the sterile package in a dry state.

11. A method for crimping a prosthetic valve, comprising:

receiving a prosthetic valve pre-assembled within a crimping device in a sterile package;

removing the crimping device and valve from the sterile package; and

using the crimping device, crimping the valve to a delivery configuration onto a delivery catheter.

12. The method of claim 11, wherein the valve is pre-assembled within the crimping device in a partially crimped configuration.

13. The method of claim 11, wherein crimping the valve comprises:

radially compressing the valve from a partially crimped configuration to the delivery configuration with the valve mounted on the delivery catheter; and

releasing compression on the valve from the crimping device.

14. The method of claim 13, wherein:

radially compressing the valve comprises rotating a knob of the crimping device from a first position to a second position; and

releasing compression on the valve comprises further rotating the knob from the second position to a third position.

15. The method of claim 14, wherein the crimping device is retained from moving axially with respect to the delivery catheter during crimping, the method further comprising releasing the crimping device from the delivery catheter by further rotating the knob from the third position to a fourth position, thereby permitting axial movement of the delivery catheter relative to the crimping device.

16. The method of claim 11, wherein the valve is sealed within the sterile package in a wet state prior to the act of removing the crimping device and valve from the sterile package.

17. The method of claim 11, wherein the valve is sealed within the sterile package in a dry state prior to the act of removing the crimping device and valve from the sterile package.

18. The method of claim 11, further comprising advancing the valve out of an outlet of the crimping device and directly into a loader.

19. The method of claim 18, wherein advancing the valve comprises coupling the outlet of the crimping device to an inlet of the loader that is already coupled to a patient.

20. The method of claim 18, wherein the loader is pre-coupled to the outlet of the crimping device within the sterile package.

21. A valve crimping device, comprising:

a radially compressible collet configured to receive a prosthetic valve, the collet comprising a first axial end portion, an opposing second axial end portion, and an intermediate portion between the first and second axial end portions, the first and second axial end portions each being tapered from a greater outer diameter adjacent to the intermediate portion to a lesser outer diameter proximate the respective axial ends of the collet; and

a mechanism for radially compressing the collet in order to crimp the valve onto a delivery catheter.

22. The device of claim 21, wherein the collet is configured to receive a prosthetic valve in a partially crimped configuration, and the mechanism is configured to crimp the valve from the partially crimped configuration to a delivery configuration.

23. The device of claim 21, wherein the intermediate portion of the collet has an outer diameter that is less than the outer diameter of the first and second axial end portions immediately adjacent to the intermediate portion.

24. The device of claim 21, wherein the collet comprises a plurality of elongated members positioned side-by-side in a cylindrical arrangement, each elongated member being connected to a first neighboring elongated member at a first end and being connected to a second neighboring elongated member at a second, opposite end.

25. The device of claim 21, further comprising a pusher comprising an internally tapered surface that is configured to slide over a corresponding externally tapered surface of the first axial end portion of the collet to compress the collet.

26. The device of claim 21, further comprising a rotatable knob coupled to the collet such that rotation of the knob causes compression of the collet.

27. The device of claim 26, wherein further rotation of the knob in the same direction releases pressure on the collet and allows the collet to expand.

28. The device of claim 21, further comprising releasable jaws configured to grip onto the delivery catheter to prevent the catheter from moving axially relative to the crimping device.