TAPERED LOADING SYSTEM FOR IMPLANTABLE MEDICAL DEVICES

• US 20090143857A1
• Filed: 12/04/2008
• Published: 06/04/2009
• Est. Priority Date: 12/04/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Chambers, Sean D., Melsheimer, Jeffry S., Paul, Ram H., Valaie, Arman H.
• Granted Patent: US 8,608,795 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: Y10T 29/53 Means to assemble or disassemble

Abstract

Loading systems for compressing and loading an implantable medical device into a device chamber of a medical device delivery system are described. The loading systems include an elongate holding chamber within which the intraluminal medical device is disposed. A plunger has one or more attached pushers adapted to axially advance the intraluminal medical device through an intermediate portion of the holding chamber that has a tapered surface, which compresses the intraluminal medical device over a dilator of a medical device delivery system that has been introduced through the distal end of the elongate holding chamber. The elongate holding chamber can be placed within an outer storage container with an appropriate seal to for storage of the intraluminal medical device within the loading system. Methods of preparing an intraluminal medical device for implantation in a patient and kits useful in such methods are also described.

Claims

1. A loading system for compressing and loading an implantable medical device into a device chamber of a medical device delivery system, said loading system comprising:

a elongate holding chamber having proximal, intermediate, and distal portions, and a wall having an internal surface defining an interior chamber having a first substantially uniform diameter in the proximal portion, a second substantially uniform diameter in the distal portion, the first substantially uniform diameter being greater than the second substantially uniform diameter and the intermediate portion having a diameter that tapers from the first substantially uniform diameter to the second substantially uniform diameter;

an intraluminal medical device having compressed and uncompressed configurations, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber;

a plunger partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein, the plunger including at least one pusher extending axially toward the intraluminal medical device and adapted to transfer axial movement thereon upon distally directed axial movement of the pusher;

a stiffening mandrel attached to the plunger and extending through the intermediate portion and into the distal portion of the elongate holding chamber, the stiffening mandrel adapted to be inserted into an end of said medical device delivery system when said medical device delivery system is positioned within the distal portion of the elongate holding chamber; and

a cap disposed about the distal portion of the elongate holding chamber.

2. The loading system according to claim 1, wherein the cap has an inner surface and the holding chamber has an outer surface, and the inner surface forms a seal with the outer surface.

3. The loading system according to claim 2, wherein the seal is a hermetic seal.

4. The loading system according to claim 1, wherein the distal portion of the elongate holding chamber defines a centering taper that provides an inwardly directed circumferential tapered surface adapted to provide a mechanical stop to proximal directed axial movement of a sheath of said delivery system when inserted into the distal portion of the elongate holding chamber.

5. The loading system according to claim 1, wherein the at least one pusher comprises two pushers.

6. The loading system according to claim 5, wherein the two pushers are disposed substantially opposite to each other relative to a lengthwise axis of the holding chamber.

7. The loading system according to claim 5, wherein each pusher has a semi-circular cross-sectional shape.

8. The loading system according to claim 5, wherein each pusher has an outwardly-directed bias.

9. The loading system according to claim 1, wherein the at least one pusher has a distal end defining a channel adapted to receive a portion of the intraluminal medical device.

10. The loading system according to claim 1, wherein the at least one pusher has a distal end defining an aperture adapted to receive a portion of the intraluminal medical device.

11. The loading system according to claim 1, wherein the at least one pusher has a distal end defining a slot adapted to receive a portion of the intraluminal medical device.

12. The loading system according to claim 1, wherein the plunger includes a flange in circumferential contact with the internal surface of the wall of the holding chamber.

13. The loading system according to claim 12, wherein the flange forms a seal with the internal surface of the wall of the elongate holding chamber.

14. The loading system according to claim 1, further comprising a storage container defining an interior chamber and an outer cap providing a seal between the interior chamber and an external environment;

wherein the elongate holding chamber is disposed substantially within the interior chamber of the storage container.

15. The loading system according to claim 14, wherein the seal is a hermetic seal.

19. The loading system according to claim 6, further comprising a storage container defining an interior chamber and an outer cap providing a seal between the interior chamber and an external environment;

wherein the elongate holding chamber is disposed substantially within the interior chamber of the storage container.

16. A loading system for compressing and loading an implantable medical device into a device chamber of a medical device delivery system, said loading system comprising:

a elongate holding chamber having proximal, intermediate, and distal portions, and a wall having an internal surface defining an interior chamber having a first substantially uniform diameter in the proximal portion, a second substantially uniform diameter in the distal portion, the first substantially uniform diameter being greater than the second substantially uniform diameter and the intermediate portion having a diameter that tapers from the first substantially uniform diameter to the second substantially uniform diameter;

an intraluminal medical device having compressed and uncompressed configurations, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber;

a plunger partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein, the plunger including first and second pushers disposed substantially opposite to each other relative to a lengthwise axis of the holding chamber, each of the first and second pushers having an outwardly-directed bias, extending axially toward the intraluminal medical device, and adapted to transfer axial movement thereon upon distally directed axial movement of the pusher;

a stiffening mandrel attached to the plunger and extending through the intermediate portion and into the distal portion of the elongate holding chamber, the stiffening mandrel adapted to be inserted into an end of said medical device delivery system when said medical device delivery system is positioned within the distal portion of the elongate holding chamber; and

a cap disposed about the distal portion of the elongate holding chamber.

17. The loading system according to claim 16, wherein the cap has an inner surface and the holding chamber has an outer surface, and the inner surface forms a seal with the outer surface.

18. The loading system according to claim 17, wherein the seal is a hermetic seal.

20. A loading system for compressing and loading an implantable medical device into a device chamber of a medical device delivery system, said loading system comprising:

a elongate holding chamber having proximal, intermediate, and distal portions, and a wall having an internal surface defining an interior chamber having a first substantially uniform diameter in the proximal portion, a second substantially uniform diameter in the distal portion, the first substantially uniform diameter being greater than the second substantially uniform diameter and the intermediate portion having a diameter that tapers from the first substantially uniform diameter to the second substantially uniform diameter;

an intraluminal medical device having compressed and uncompressed configurations, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber;

a plunger partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein, the plunger including first and second pushers disposed substantially opposite to each other relative to a lengthwise axis of the holding chamber, each of the first and second pushers having an outwardly-directed bias, extending axially toward the intraluminal medical device, and adapted to transfer axial movement thereon upon distally directed axial movement of the pusher;

a stiffening mandrel attached to the plunger and extending through the intermediate portion and into the distal portion of the elongate holding chamber, the stiffening mandrel adapted to be inserted into an end of said medical device delivery system when said medical device delivery system is positioned within the distal portion of the elongate holding chamber;

a cap disposed about the distal portion of the elongate holding chamber; and

a storage container defining an interior chamber and an outer cap providing a seal between the interior chamber and an external environment;

wherein the elongate holding chamber is disposed substantially within the interior chamber of the storage container.