System for loading a collapsible heart valve

Patent metadata

Field	Value
Publication number	US-8931159-B2
Application number	US-201213558942-A
Country	US
Kind code	B2
Filing date	Jul 26, 2012
Priority date	Jul 28, 2011
Publication date	Jan 13, 2015
Grant date	Jan 13, 2015

Abstract

An assembly for collapsing a self-expanding prosthetic heart valve includes a compression member, a support member and a constricting member. The compression member has a tapered wall between its first open end and its second open end, the tapered wall defining an open space adapted to receive the valve. The support member has a base and a recess adapted to receive an end of the valve. The support member and the compression member are movable toward one another to compress the valve and push it through a relatively small aperture in the second open end of the compression member. The second end of the constricting member is sized to receive the compressed valve from the second open end of the compression member for loading into a delivery device.

First claim

The invention claimed is:

1. An assembly for loading a self-expanding prosthetic device into a delivery device, comprising:
a compression member having a longitudinal axis, a first open end with a first diameter, a second open end with a second diameter less than the first diameter, and a wall decreasing in diameter in a distal direction from the first open end towards the second open end, the wall defining an open space adapted to receive the prosthetic device;
a support member having a longitudinal axis, a base and a through bore extending along the longitudinal axis of the support member, the through bore being sized to receive a portion of the delivery device therethrough, the support member having a recess extending around the through bore adapted to receive an end of the prosthetic device, the support member and the compression member being movable relative to one another between an initial position in which the base of the support member is relatively far from the first open end of the compression member and an operative position in which the base of the support member is relatively close to the first open end of the compression member, wherein movement of the support member and the compression member from the initial position to the operative position pushes the prosthetic device at least partially through the open space such that at least a portion of the prosthetic device is radially compressed by the wall of the compression member as the prosthetic device advances through the open space; and
a constricting member having a lumen defined therethrough, the lumen having proximal end and a distal end, the proximal end of the lumen being sized to receive the second open end of the compression member.

2. The assembly according to claim 1 , wherein distal end of the lumen is sized to slidably receive at least a portion of the delivery device.

3. The assembly according to claim 2 , wherein the constricting member further includes a pair of seals disposed within the lumen of the constricting member, the seals being constructed and arranged to seal to the compression member and to the delivery device.

4. The assembly according to claim 1 , wherein the compression member includes a tubular extension on the second open end of the compression member, the tubular extension having a lumen therethrough, the tubular extension being engageable with the proximal end of the constricting member.

5. The assembly according to claim 1 , wherein the compression member includes a tubular extension at the second open end of the compression member, the tubular extension having a lumen therethrough, the lumen having a diameter which is substantially equal to the second diameter.

6. The assembly according to claim 5 , wherein the proximal end of the lumen in the constricting member is sized and shaped for assembly to the tubular extension.

7. The assembly according to claim 1 , wherein the wall of the compression member decreases in diameter uniformly from the first open end to the second open end.

8. The assembly according to claim 1 , further comprising a locking assembly for locking the compression member to the support member.

9. The assembly according to claim 8 , wherein the locking assembly includes a male connecting member on one of the support member or the compression member, and a female connecting member on the other of the support member or the compression member for mating with the male connecting member.

10. The assembly according to claim 9 , wherein the male connecting member includes a plurality of pins extending in radial directions from the longitudinal axis of the one of the support member or the compression member, and the female connecting member includes a plurality of features on the other of the support member or the compression member adapted to mate with the plurality of pins.

11. The assembly according to claim 1 , wherein the support member has a longitudinal slit in communication with the through bore to allow for removal of the support member from the delivery device.

12. The assembly according to claim 1 , further comprising a distal plug configured to seal a distal tip of the delivery catheter.

13. A method for loading a self-expanding prosthetic device into a delivery device, the delivery device including a distal tip, a proximal conical end, a retaining element, a compartment defined between the proximal conical end and the retaining element and adapted to receive the prosthetic device, and a distal sheath movable between a closed position fully covering the compartment and an open position uncovering the compartment, and the prosthetic device including a stent, and at least one retainer at one end of the stent, the prosthetic device having an expanded condition and a collapsed condition, the method comprising:
inserting the prosthetic device in the expanded condition into a compression member having an inner surface which decreases in diameter progressively from a first open end to a second open end;
initially advancing the prosthetic device through the compression member until the at least one retainer protrudes from the second open end of the compression member;
advancing a delivery device through the first open end of the compression member until the at least one retainer of the prosthetic device is disposed near the retaining element of the delivery device and moving the delivery device into the open position to uncover the compartment;
attaching the at least one retainer of the prosthetic device to the retaining element of the delivery device; and
moving the distal sheath of the delivery device to the closed position, and further advancing the prosthetic device through the second open end of the compression member.

14. The method according to claim 13 , further comprising filling at least a portion of the compression member with a sterile liquid to remove air from the prosthetic device and the delivery device before moving the distal sheath of the delivery device to the closed position.

15. The method according to claim 14 , further comprising sealing the sheath of the delivery device to the compression member prior to the filling step.

16. The method according to claim 15 wherein the delivery device further includes a tube extending to the distal tip and communicating with a space within the sheath adjacent a distal end of the sheath, the method further comprising introducing sterile liquid into the sheath through the tube.

17. The method according to claim 16 wherein the tube communicates with a passage through the distal tip of the delivery device, coupling a distal plug to the distal tip of the delivery device to seal the passage prior to introducing sterile liquid through the tube.

18. The method according to claim 15 wherein the sealing step includes assembling a proximal end of a constricting member to second open end of the compression member and sealing a distal end of the constricting member to the sheath of the delivery device, the step of further advancing the prosthetic valve through the second open end of the compression member including advancing the prosthetic valve through a lumen in the constricting member.

19. The method according to claim 13 , further comprising agitating the sterile liquid in the compression member to facilitate removal of air from the prosthetic device and the delivery device.

20. The method according to claim 19 , wherein the agitating step includes moving a syringe in the sterile liquid adjacent the retaining element of the delivery device.

2

Assignees

• Hillukka Brett Allen
• St Jude Medical Cardiology Div

Inventors

• Hillukka Brett Allen

Classifications

• A61F2/9522

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

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• Y10T29/49826

  Assembling or joining · CPC title

• A61F2/97

  the outer sleeve being splittable · CPC title

• Y10T29/49913

  by constricting outer annulus · CPC title