TAPERED LOADING SYSTEM FOR IMPLANTABLE MEDICAL DEVICES

• US 20140081387A1
• Filed: 11/11/2013
• Published: 03/20/2014
• Est. Priority Date: 12/04/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S., Chambers, Sean D., Valaie, Arman H., Paul, Ram H.
• Granted Patent: US 9,629,704 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 2/95 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:

an elongate holding chamber having proximal, intermediate, and distal portions, a proximal end, a distal end, 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, the proximal end defining a proximal opening in communication with the interior chamber in the proximal portion;

an intraluminal medical device having compressed and uncompressed configurations, an intraluminal medical device proximal end and an intraluminal medical device distal end, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber and contacting the internal surface of the elongate holding chamber such that the intraluminal medical device proximal end is oriented toward the proximal end of the elongate holding chamber and the intraluminal medical device distal end is oriented toward the distal end of the elongate holding chamber;

at least one pusher disposed in the elongate holding chamber and defining a pusher distal end that receives a portion of the intraluminal medical device, the at least one pusher adapted to apply tension to the intraluminal medical device upon distally directed axial movement of the pusher.

2. The loading system of claim 1, wherein the at least one pusher comprises two pushers.

3. The loading system of claim 2, wherein the two pushers are disposed substantially opposite to each other relative to a lengthwise axis of the holding chamber.

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

5. The loading system of claim 1, further comprising a plunger extending through the proximal opening and partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein;

wherein the at least one pusher is connected to the plunger.

6. The loading system of claim 5, wherein the plunger includes a flange in circumferential contact with the internal surface of the wall of the holding chamber.

7. The loading system of claim 6, wherein the flange forms a seal with the internal surface of the wall of the elongate holding chamber.

8. The loading system of 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.

9. The loading system of claim 8, wherein the seal is a hermetic seal.

10. The loading system of claim 1, wherein the intraluminal medical device comprises an intraluminal valve device.

11. The loading system of claim 10, wherein the intraluminal valve device includes one or more tissue-derived components.

12. The loading system of claim 11, wherein the intraluminal valve device comprises one of a prosthetic heart valve and a prosthetic venous valve.

13. 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:

an elongate holding chamber having proximal, intermediate, and distal portions, a proximal end, a distal end, 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, the proximal end defining a proximal opening in communication with the interior chamber in the proximal portion;

an intraluminal medical device having compressed and uncompressed configurations, an intraluminal medical device proximal end and an intraluminal medical device distal end, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber and contacting the internal surface of the elongate holding chamber such that the intraluminal medical device proximal end is oriented toward the proximal end of the elongate holding chamber and the intraluminal medical device distal end is oriented toward the distal end of the elongate holding chamber;

a plunger extending through the proximal opening and partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein; and

first and second pushers connected to the plunger, each of the first and second pushers disposed in the elongate holding chamber, defining a pusher distal end that receives a portion of the intraluminal medical device, and adapted to apply tension to the intraluminal medical device upon distally directed axial movement of the pusher.

14. The loading system of claim 13, wherein the first and second pushers are disposed substantially opposite to each other relative to a lengthwise axis of the holding chamber.

15. The loading system of claim 13, wherein the pusher distal end of one of the first and second pushers defines a slot adapted to receive a portion of the intraluminal medical device.

16. The loading system of claim 13, wherein the pusher distal end of each of the first and second pushers defines a slot adapted to receive a portion of the intraluminal medical device.

17. The loading system of claim 13, wherein the intraluminal medical device comprises an intraluminal valve device.

18. The loading system of claim 17, wherein the intraluminal valve device includes one or more tissue-derived components.

19. The loading system of claim 18, wherein the intraluminal valve device comprises one of a prosthetic heart valve and a prosthetic venous valve.

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:

an elongate holding chamber having proximal, intermediate, and distal portions, a proximal end, a distal end, 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, the proximal end defining a proximal opening in communication with the interior chamber in the proximal portion;

an intraluminal medical device having compressed and uncompressed configurations and including one or more tissue-derived components, an intraluminal medical device proximal end and an intraluminal medical device distal end, the intraluminal medical device disposed at least partially in at least one of the intermediate and proximal portions of the elongate holding chamber and contacting the internal surface of the elongate holding chamber such that the intraluminal medical device proximal end is oriented toward the proximal end of the elongate holding chamber and the intraluminal medical device distal end is oriented toward the distal end of the elongate holding chamber;

a plunger extending through the proximal opening and partially disposed in the proximal portion of the elongate holding chamber and capable of slideable movement therein; and

first and second pushers connected to the plunger, each of the first and second pushers disposed in the elongate holding chamber, defining a slot adapted to receive a portion of the intraluminal medical device, and adapted to apply tension to the intraluminal medical device upon distally directed axial movement of the pusher.