System and method for crimping a prosthetic heart valve

• US 10,307,250 B2
• Filed: 03/07/2016
• Issued: 06/04/2019
• 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:
  US15/063,319
• Publication Number:
  US 20160184096A1
• Time in Patent Office: 1,184 Days
• Field of Search: 72402
• 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: 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 collet configured to receive a prosthetic valve in a radially expanded state;

a housing member configured to receive the collet;

a pusher member that is movable relative to the collet;

a rotatable knob coupled to the housing member and the pusher member, wherein when the knob is rotated relative to the housing member, the knob pushes the pusher member axially over the collet, which applies a radial force against the collet to cause radial crimping of the prosthetic valve.

2. The crimping device of claim 1, wherein the knob is threadably engaged to the housing member such that rotation of the knob causes the knob to move axially over the housing member.

3. The crimping device of claim 2, wherein the housing member comprises an internally tapered surface and further wherein rotation of the knob causes the pusher member to move closer to the tapered surface, which results in relative axial movement between the tapered surface and the collet.

4. The crimping device of claim 2, wherein the knob has internal threads that engage external threads of the housing member.

5. A method for crimping a prosthetic valve, the method comprising:

rotating a rotatable knob of a crimping device relative to a housing member of the crimping device to radially compress a prosthetic valve from an expanded or partially crimped configuration to a delivery configuration.

6. The method of claim 5, wherein rotation of the knob advances the prosthetic valve out of an outlet of the crimping device.

7. The method of claim 6, wherein rotation of the knob causes the knob to move axially relative to the housing member.

8. The method of claim 6, further comprising moving the prosthetic valve in the delivery configuration into a sheath of a delivery apparatus.

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

a housing member configured to house at least a portion of a prosthetic valve;

a pusher member axially movable relative to the housing member wherein axial movement of the pusher member relative to the housing member is effective to compress the prosthetic valve from an expanded or partially crimped configuration to a delivery configuration; and

a rotatable knob that is threadably engaged and rotatable relative to the housing member, wherein the pusher member is received in the knob such that rotation of the knob relative to the housing member causes axial movement of the pusher member relative to the housing.

10. The crimping device of claim 9, wherein the pusher member includes a generally cylindrical external surface that is received within the housing member.

11. The crimping device of claim 9, wherein the housing member comprises an internally tapered surface and further wherein the pusher member, when moved axially upon rotation of the knob, moves closer to the tapered surface to cause relative axial movement between the tapered surface and the prosthetic valve.

12. The crimping device of claim 11, wherein the pusher member includes a pusher internal annular ledge and further wherein rotation of the knob causes relative axial movement between the tapered surface and the pusher internal annular ledge.

13. The crimping device of claim 9, further comprising a sterile package containing a delivery catheter, the crimping device and the prosthetic valve.

14. The crimping device of claim 13, wherein the prosthetic valve is pre-assembled in a partially crimped configuration within the crimping device and within the sterile package.

15. The crimping device of claim 9, wherein the knob has internal threads that engage external threads of the housing member.

16. A method for crimping a prosthetic valve, the method comprising:

rotating a rotatable knob of a crimping device relative to a housing member of the crimping device, wherein the rotatable knob is threadably engaged with the housing member, and wherein the crimping device includes a pusher member inside the housing;

wherein rotating the rotatable knob causes the pusher member to move axially relative to the housing, thereby radially compressing a prosthetic valve in the housing from an expanded or partially crimped configuration to a delivery configuration.

17. The method of claim 16, further comprising after radially compressing the prosthetic valve to the delivery configuration, moving the prosthetic valve into a sheath of a delivery apparatus.

18. The method of claim 16, wherein the pusher member includes a generally cylindrical external surface that is received within the housing member.

19. The method of claim 16, wherein the knob extends co-axially over the housing member and has internal threads that engage external threads of the housing member.

20. The method of claim 16, wherein prior to rotating the rotatable knob, removing a delivery catheter, the crimping device and the prosthetic valve from a sterile package.