System and method for crimping a prosthetic valve

• US 8,986,320 B2
• Filed: 02/14/2014
• Issued: 03/24/2015
• 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 T.
• Primary Examiner(s): Jones, David B
• Application Number:
  US14/181,425
• Publication Number:
  US 20150007630A1
• Time in Patent Office: 403 Days
• Field of Search: 606/1, 606/108, 606/198, 724/02, 724/091.9, 724/821, 292/19, 292/37, 292/82, 292/835, 294/47, 295/15, 295/16, 206/370, 206/438
• 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

A device for crimping a radially expandable and collapsible prosthetic valve comprises a coiled wire frame having a longitudinal opening extending from a proximal end to a distal end thereof. The opening has a first state and a second state, the opening in the first state having a first diameter dimensioned to receive the prosthetic valve in an expanded or partially crimped configuration therein, and the opening in the second state having a second diameter dimensioned to receive the prosthetic valve in a crimped configuration. The coiled wire frame has a first end coupled to a first member and a second end coupled to a second member. The first member is movable relative to the second member to convert the coiled wire frame from the first state to the second state.

Claims

1. A crimping device for crimping a radially expandable and compressible prosthetic valve, the crimping device comprising:

a coiled wire frame comprising a first end, a second end, a proximal end, a distal end, and a longitudinal opening extending between the proximal end and the distal end;

a first member coupled to the first end of the coiled wire frame; and

a second member coupled to the second end of the coiled wire frame, the second member movable relative to the first member,

wherein

the coiled wire frame has a first state and a second state, the opening of the coiled wire frame having a first diameter in the first state and a second diameter in the second state, the first diameter greater than the second diameter, the first diameter dimensioned to receive a prosthetic valve in an expanded or partially crimped configuration, the second diameter dimensioned to receive the prosthetic valve in a crimped configuration, and

the first member is operably movable relative to the second member to convert the coiled wire frame from the first state to the second state.

2. The crimping device of claim 1, further comprising a housing, the housing enclosing the coiled wire frame, the first member, and the second member.

3. The crimping device of claim 2, further comprising a proximal end cap.

4. The crimping device of claim 2, further comprising a distal loader.

5. The crimping device of claim 1, further comprising a screw knob, the screw knob operable for moving the first member relative to the second member.

6. A system for crimping a prosthetic valve, the system comprising:

the crimping device of claim 1 in the first state; and

a prosthetic valve in an expanded or partially crimped configuration positioned in the opening in the coiled wire frame.

7. The system of claim 6, further comprising sterile packaging, the crimping device and prosthetic device disposed in the sterile packaging.

8. A method for crimping radially expandable and compressible prosthetic valve, the method comprising:

reducing a diameter of an opening extending from a proximal end to a distal end of a coiled wire frame in which a prosthetic valve in an expanded or partially crimped configuration is disposed, thereby crimping the prosthetic valve.

9. The method of claim 8, wherein reducing a diameter of the opening comprises moving a first member relative to a second member, the first member coupled to a first end of the coiled wire frame, and the second member coupled to a second end of the coiled wire frame.

10. The method of claim 9, wherein moving the first member relative to the second member comprises rotating a screw knob.

11. The method of claim 8, further comprising positioning the prosthetic valve in the expanded or partially crimped configuration within the opening of the coiled wire frame.

12. The method of claim 11, wherein positioning the prosthetic valve comprises positioning the prosthetic valve mounted on a delivery catheter, thereby crimping the prosthetic valve onto the delivery catheter.

13. The method of claim 8, further comprising releasing the crimped prosthetic valve from the coiled wire frame.

14. The method of claim 13, further comprising retracting the crimped prosthetic valve proximally.

15. The method of claim 13, further comprising advancing the crimped prosthetic valve through a loader.