System for loading a collapsible heart valve

• US 8,893,370 B2
• Filed: 06/28/2012
• Issued: 11/25/2014
• Est. Priority Date: 07/28/2011
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Hillukka, Brett Allen, Le, Khoi, Thomas, Ralph Joseph, Glazier, Valerie J.
• Primary Examiner(s): Hong, John C
• Application Number:
  US13/535,591
• Publication Number:
  US 20130166020A1
• Time in Patent Office: 880 Days
• Field of Search: 295/05, 295/06, 295/08, 294/28, 623/2.11, 623/1.11, 623/909
• US Class Current: 29/505
• 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0064 Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: Y10T 29/49908 Joining by deforming

Abstract

An assembly for collapsing a self-expanding prosthetic heart valve includes a compression member, a support member, a constricting member, and a spacer which may be used for smaller sized heart valves. 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 heart valve. The support member has a base and a recess adapted to receive an end of the heart valve. The support member and the compression member are movable toward one another to compress the heart 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 heart valve from the second open end of the compression member for loading into a delivery device.

Claims

1. An assembly for loading a self-expanding prosthetic heart valve into a delivery device, comprising:

a compression member having a first open end with a first diameter, a second open end with a second diameter less than the first diameter, and a tapered wall decreasing in diameter from the first open end to the second open end, the tapered wall defining an open space adapted to receive the heart valve;

a support member having a base on a first end and a recess on a second end, the recess having a fixed depth between a support surface of the recess and an open end of the recess, the recess being adapted to receive an end of the heart valve, 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 heart valve through the open space such that the heart valve is radially compressed by the tapered wall of the compression member as the heart valve advances through the open space;

a constricting member having a first end and a second end, the second end of the constricting member being sized to receive the compressed heart valve from the second open end of the compression member; and

a spacer adapted for assembly in the recess so that the recess has a depth between a support surface of the spacer and the open end of the recess which is less than the fixed depth.

2. The assembly according to claim 1, further comprising

a tubular extension on the second open end of the compression member, the tubular extension having a lumen therethrough;

and

a first seal interposed between the delivery device and the tubular extension of the compression member.

3. The assembly according to claim 1, further comprising a tubular extension on 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.

4. The assembly according to claim 3, wherein the second end of the constricting member is sized and shaped for assembly to the tubular extension.

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

6. The assembly according to claim 5, 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.

7. The assembly according to claim 6, 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.

8. The assembly according to claim 1, wherein the support member has a through bore extending from the base to the recess, the through bore being sized to receive a tip of the delivery device therethrough.

9. The assembly according to claim 8, wherein the spacer is releasably connectable to the through bore.

10. A method for loading a self-expanding prosthetic heart valve into a delivery device, the delivery device including a tip, a retaining element, a compartment defined between the tip and the retaining element and adapted to receive the heart valve, and a distal sheath movable between a closed position fully covering the compartment and an open position uncovering the compartment, and the heart valve including a stent, a valve assembly supported by the stent, and at least one retainer at one end of the stent, the heart valve having an expanded condition and a collapsed condition, the method comprising:

configuring a support member to receive an end of the heart valve, the support member having a base on a first end and a recess on a second end, the recess having a fixed depth between a support surface of the recess and an open end of the recess, the configuring step including assembling a spacer in the recess so that the recess has a depth between a support surface of the spacer and the open end of the recess which is less than the fixed depth;

inserting the end of the heart valve in the expanded condition into the recess of the support member;

advancing the support member and a compression member toward one another, the compression member having an inner surface which decreases in diameter uniformly from a first open end to a second open end, the advancing step including advancing the heart valve through the compression member until the at least one retainer protrudes from the second open end of the compression member;

positioning the delivery device in an initial position in a constricting member, the constricting member having a first end, a second end, and an elongated tubular portion between the first end and the second end, the delivery device in the initial position having the distal sheath in the open position and the retaining element positioned outside the constricting member;

attaching the at least one retainer of the heart valve to the retaining element of the delivery device; and

moving the distal sheath of the delivery device to the closed position, during which the heart valve is advanced through the second open end of the compression member and into the elongated tubular portion of the constricting member to place the heart valve in the collapsed condition.

11. The method according to claim 10, further comprising filling at least a portion of the compression member with a sterile liquid before moving the distal sheath of the delivery device to the closed position to remove air from the heart valve and the delivery device.

12. The method according to claim 10, further comprising joining the constricting member to the compression member after attaching the at least one retainer of the heart valve to the retaining element of the delivery device.

13. The method according to claim 10, further comprising connecting the support member to the compression member after the advancing step.

14. A kit for delivering a self-expanding prosthetic heart valve to an implantation site in a patient, the heart valve being one of a plurality of different sizes, the kit comprising:

a delivery device including a tip, a retaining element, a compartment defined between the tip and the retaining element and adapted to receive the heart valve, and a distal sheath movable between a closed position fully covering the compartment and an open position uncovering the compartment;

a compression member having a first open end with a first diameter, a second open end with a second diameter less than the first diameter, and a tapered wall decreasing in diameter from the first open end to the second open end, the tapered wall defining an open space adapted to receive the heart valve;

a support member having a base on a first end and a recess on a second end, the recess having a fixed depth between a support surface of the recess and an open end of the recess, the recess being adapted to receive an end of the heart valve, 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 heart valve through the open space such that the heart valve is radially compressed by the tapered wall of the compression member as the heart valve advances through the open space;

a constricting member having a first end and a second end, the second end of the constricting member being sized to receive the compressed heart valve from the second open end of the compression member; and

a spacer adapted for assembly in the recess so that the recess has a second depth between a support surface of the spacer and the open end of the recess which is less than the fixed depth,

wherein the fixed depth of the recess is adapted for use with a heart valve having a first compressed length, and the second depth of the recess is adapted for use with a heart valve having a compressed length less than the first compressed length.

15. The kit according to claim 14, further comprising a plurality of spacers adapted for assembly in the recess, each spacer being adapted to reduce the depth of the recess by a selected amount, the selected amount for one spacer being different from the selected amount for each of the other spacers.