SYSTEM FOR LOADING A COLLAPSIBLE HEART VALVE

• US 20120330408A1
• Filed: 02/02/2012
• Published: 12/27/2012
• Est. Priority Date: 02/02/2011
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Wang, Huisun, Glazier, Valerie J., Alkhatib, Yousef F., Daly, Jacob John, Thomas, Ralph Joseph, Hillukka, Brett Allen
• Granted Patent: US 9,021,674 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/007 O-rings
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2250/0091 transparent or translucent
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/53909 Means comprising hand manipulatable tool
• CPC Class Codes: Y10T 29/53943 Hand gripper for direct push or pull

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.

Claims

1. An assembly for loading a self-expanding prosthetic heart valve 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 from the first open end to the second open end, the wall defining an open space adapted to receive the valve;

a support member having a longitudinal axis, a base and a recess extending along the longitudinal axis and adapted to receive an end of the 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 valve through the open space such that the valve is radially compressed by the tapered wall of the compression member as the valve advances through the open space; and

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

2. The assembly according to claim 1, wherein the constricting member includes an elongated tubular portion between the first end and the second end, the elongated tubular portion having a lumen sized to slidably receive at least a distal sheath of the delivery device.

3. The assembly according to claim 2, wherein the constricting member further includes an end member on the second end, the end member having a free end and another end connected to the tubular portion, the lumen of the tubular portion having a substantially constant diameter, and the end member having a first diameter at the free end, a second diameter less than the first diameter at the another end, and a wall decreasing in diameter from the free end to the another end.

4. The assembly according to claim 3, further comprising

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

and

a first seal interposed between the end member of the constricting member and the tubular extension of the compression member.

5. The assembly according to claim 4, further comprising a second seal disposed in the lumen of the elongated tubular portion of the constricting member.

6. The assembly according to claim 2, wherein the constricting member further includes an end member on the first and second ends thereof, each end member having a free end and another end connected to the tubular portion, the lumen of the tubular portion having a substantially constant diameter, and each end member having a first diameter at the free end, a second diameter less than the first diameter at the another end, and a wall decreasing in diameter from the free end to the another end.

7. 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.

8. The assembly according to claim 7, wherein the second end of the constricting member is sized and shaped for assembly to the tubular extension.

9. The assembly according to claim 1, wherein the constricting member includes a plurality of interlocking segments connected to one another, each of the interlocking segments having a first end with a first diameter, a second end with a second diameter greater than the first diameter, and a wall increasing in diameter from the first end to the second end, the interlocking segments being connected together in series with the second end of one interlocking segment connected to the first end of a next adjacent interlocking segment.

10. The assembly according to claim 9, wherein the diameter of the wall increases in step-wise fashion.

11. The assembly according to claim 9, wherein the diameter of the wall increases uniformly from the first end to the second end.

12. The assembly according to claim 1, further comprising at least one tear line extending in a longitudinal direction between the first end and the second end of the constricting member for splitting the constricting member in the longitudinal direction.

13. 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.

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

15. The assembly according to claim 14, 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.

16. The assembly according to claim 15, 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.

17. The assembly according to claim 15, wherein the female connecting member includes an annular groove extending along an inner surface of the first open end of the compression member, and the male connecting member includes a plurality of locking tabs on the support member adapted to engage the annular groove of the compression member so as to connect the support member to the compression member.

18. The assembly according to claim 15, wherein the male connecting member includes an annular rim extending from the first open end of the compression member, and the female connecting member includes an annular slot on the support member sized to receive the rim so as to connect the compression member to the support member.

19. The assembly according to claim 14, wherein the locking assembly includes a bead extending along an outer periphery of the first open end of the compression member and locking tabs on the support member, the locking tabs being configured to engage the bead of the compression member so as to connect the support member to the compression member.

20. The assembly according to claim 1, wherein the support member has a through bore extending along the longitudinal axis of the support member, the through bore being sized to receive a tip of the delivery device there through.

21. 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:

inserting the heart valve in the expanded condition into a compression member having an inner surface which decreases in diameter uniformly from a first open end to a second open end;

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.

22. The method according to claim 21, 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.

23. The method according to claim 22, further comprising removing air from the heart valve and the delivery device by agitating the sterile liquid in the compression member.

24. The method according to claim 23, wherein the valve assembly includes an annular cuff supported by the stent and a plurality of leaflets supported within the cuff, and the air removal step includes moving a probe in the sterile liquid between the cuff and the plurality of leaflets.

25. The method according to claim 24, wherein the air removal step includes moving a syringe in the sterile liquid adjacent the retaining element of the delivery device.

26. The method according to claim 21, wherein the delivery device further includes a tubular outer shaft between the retaining element and an operating handle, the method further comprising dispensing a sterile liquid into the delivery device to remove air bubbles from the outer shaft.

27. The method according to claim 21, further comprising submerging the distal sheath of the delivery device and the heart valve into a container holding 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.

28. The method according to claim 21, 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.

29. The method according to claim 21, wherein the step of advancing the heart valve includes pushing the heart valve through the compression member using a support member, the support member having a recess dimensioned to receive at least a portion of the heart valve.

30. The method according to claim 29, further comprising connecting the support member to the compression member after the step of advancing the heart valve.