Crimping device

Patent metadata

Field	Value
Publication number	US-10918478-B2
Application number	US-201715682981-A
Country	US
Kind code	B2
Filing date	Aug 22, 2017
Priority date	Jul 27, 2011
Publication date	Feb 16, 2021
Grant date	Feb 16, 2021

Abstract

A crimping system for a prosthetic heart valve comprises an elongate rigid body and a radially flexible, tubular sock. The body has an inner lumen extending along a central longitudinal axis between an insertion end and an outlet end. The inner lumen has a greater diameter at the insertion end than at the outlet end. The sock is configured to receive a radially compressible prosthetic heart valve in a radially expanded state within the sock and to pull the valve through the inner lumen of the rigid body from the insertion end to the outlet end with the sock being positioned between an outer surface of the valve and an inner surface of the rigid body. The valve is radially compressed by the inner surface of the rigid body as the sock pulls the valve along the longitudinal axis toward the outlet end of the lumen.

First claim

We claim:

1. A crimping system for crimping a prosthetic heart valve, the system comprising:
an elongate rigid body having an inner lumen extending along a central longitudinal axis between an insertion end and an outlet end, the inner lumen having a greater diameter at the insertion end than at the outlet end; and
a radially flexible, tubular sock configured to receive a radially compressible prosthetic heart valve in a radially expanded state within the sock and to pull the prosthetic heart valve through the inner lumen of the rigid body from the insertion end to the outlet end with the sock being positioned between an outer surface of the prosthetic heart valve and an inner surface of the rigid body, wherein the sock has an axial length greater than an axial length of the rigid body, and wherein the prosthetic heart valve is radially compressed by the inner surface of the rigid body as the sock pulls the prosthetic heart valve along the longitudinal axis toward the outlet end of the lumen.

2. The crimping system of claim 1 , wherein the inner lumen of the rigid body comprises a cylindrical loading portion adjacent to the insertion end and a tapered crimping portion extending from the loading portion toward the outlet end, the loading portion have an inner diameter slightly larger than an outer diameter of the prosthetic heart valve in the radially expanded state.

3. The crimping system of claim 2 , wherein the tapered crimping portion comprises a first tapered crimping portion adjacent to the loading portion and a second tapered crimping portion extending from the first tapered crimping portion toward the outlet end, wherein the first tapered crimping has a relatively more gradual taper than the second tapered crimping portion.

4. The crimping system of claim 1 , wherein a coefficient of friction between an outer surface of the sock and the inner surface of the rigid body is less than a coefficient of friction between an inner surface of the sock and an outer surface of the prosthetic heart valve, such that the sock does not move axially relative to the prosthetic heart valve while the sock slides along the inner surface of the rigid body.

5. The crimping system of claim 4 , wherein the outer surface of the sock comprises a first material and the inner surface of the sock comprises a second material.

6. The crimping system of claim 1 , wherein the rigid body and the sock are configured to crimp the prosthetic heart valve onto a shaft that is moved through the lumen of the rigid body along with the prosthetic heart valve and the sock.

7. The crimping system of claim 1 , wherein the sock comprises a mesh fabric that is substantially more flexible in a radially direction than in a longitudinal direction.

8. The crimping system of claim 1 , wherein the sock comprises polyethylene terephthalate.

9. The crimping system of claim 1 , wherein the sock comprises a plurality of first strands arranged circumferentially around the sock that are resiliently stretchable and a plurality of second strands arranged circumferentially around the sock that are relatively less stretchable than the first strands.

10. A method of crimping a prosthetic heart valve, the method comprising:
providing an elongate shaft and a radially flexible tubular sock positioned within and extending through a lumen of an elongate rigid body with the sock positioned between the shaft and the rigid body, the lumen having a diameter that decreases moving axially from an insertion end to an opposite outlet end, the sock having an axial length greater than an axial length of the rigid body, and wherein a radially compressible prosthetic heart valve in a radially expanded state is positioned between the shaft and the sock and within a loading portion of the lumen adjacent to the insertion end; and
pulling the sock through the lumen toward the outlet end such that the sock pulls the prosthetic heart valve through the lumen from the loading portion, through a tapered portion of the lumen, and out of the outlet end, thereby crimping the prosthetic heart valve as it is pulled through the lumen.

11. The method of claim 10 , wherein the prosthetic heart valve is positioned around the shaft at a given axial position along the shaft, and wherein the shaft is pulled through the lumen at the same rate as the prosthetic heart valve such that the prosthetic heart valve is crimped onto the shaft at the given axial position along the shaft.

12. The method of claim 10 , wherein the sock is longer than the lumen such that the sock extends from both the insertion end and the outlet end of the lumen when the prosthetic heart valve is loaded into the loading portion of the lumen.

13. The method of claim 10 , wherein the loading portion of the lumen is generally cylindrical and has an inner diameter about equal to an outer diameter of the prosthetic heart valve in the radially expanded state.

14. The method of claim 10 , wherein the loading portion of the lumen is generally cylindrical and has an inner diameter that is less than the outer diameter of the prosthetic heart valve in the radially expanded state, and wherein the prosthetic heart valve is partially crimped before it is positioned within the loading portion of the lumen.

15. The method of claim 10 , wherein pulling the sock through the lumen comprises holding the sock and the prosthetic heart valve axially stationary while moving the rigid body axially over the sock and the prosthetic heart valve.

16. The method of claim 10 , wherein the sock comprises a mesh fabric that is substantially more flexible in a radially direction than in a longitudinal direction.

17. The method of claim 10 , wherein a coefficient of friction between an outer surface of the sock and the inner surface of the rigid body is less than a coefficient of friction between an inner surface of the sock and an outer surface of the prosthetic heart valve, such that the sock does not move axially relative to the prosthetic heart valve while the sock is pulled through the lumen.

18. The method of claim 10 , wherein the loading portion of the lumen is cylindrical and the tapered portion of the lumen has a diameter that decreases moving axially from the loading portion toward the outlet end.

19. The method of claim 10 , wherein the tapered portion of the lumen comprises a first tapered portion adjacent to the loading end having a first tapered diameter that decreases moving axially from the loading portion toward the outlet end and a second tapered portion extending from the first tapered portion toward the outlet end having a second tapered diameter, wherein the first tapered diameter decreases relatively more gradually than the second tapered diameter.

Assignees

• Edwards Lifesciences Corp

Inventors

• Taft Rob
• Oba Travis Zenyo

Classifications

• A61F2/9525

  using a funnel · CPC title

• A61F2230/0065

  toroidal, e.g. ring-shaped, doughnut-shaped · CPC title

• A61F2230/0067

  conical · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · CPC title