LOADING APPARATUS AND SYSTEM FOR EXPANDABLE INTRALUMINAL MEDICAL DEVICES

• US 20110046712A1
• Filed: 08/20/2010
• Published: 02/24/2011
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Valaie, Arman, Burke, Jessica L., Chambers, Sean D., Melsheimer, Jeffry S.
• Granted Patent: US 8,585,019 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• 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: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: Y10T 29/53843 Tube, sleeve, or ferrule inserting or removing

Abstract

Medical device loading apparatuses, systems, methods and kits are described. A loading apparatus comprises a main body having a proximal end defining a proximal opening, a distal end defining a distal opening, and a passageway extending between the proximal and distal openings. The passageway defines a proximal chamber having a first inner diameter, a distal chamber having a second inner diameter, and a transition chamber disposed between the proximal and distal chambers. The transition chamber has an inner diameter that transitions from the larger second inner diameter to the smaller first inner diameter. The main body has a separable connection that divides the main body between proximal and distal portions when disrupted. An expandable intraluminal medical device can be loaded into a delivery catheter using the loading apparatus by placing the device into the passageway such that it is in a radially-expanded configuration; pulling the device along an axial path through the loading apparatus such that the device transitions from the radially-expanded configuration to a radially-compressed configuration; and pushing the radially-compressed device along the axial path into the delivery catheter.

Claims

1. An apparatus for loading an expandable intraluminal medical device into a delivery catheter, said apparatus comprising:

a main body having a lengthwise axis, a proximal end defining a proximal opening, a distal end defining a distal opening, and a main body passageway extending between the proximal and distal openings, the main body passageway defining a proximal chamber having a first inner diameter, a distal chamber having a second inner diameter, and a transition chamber disposed between the proximal and distal chambers, the second inner diameter being greater than the first inner diameter and the transition chamber having an inner diameter that transitions along the lengthwise axis from the second inner diameter to the first inner diameter, the main body having proximal and distal portions connected to each other at a separable connection;

an inner sleeve comprising a tubular body and a distal flange, the tubular body disposed within the main body passageway and the distal flange extending outwardly relative to the lengthwise axis of the main body and disposed between the proximal and distal portions of the main body;

a proximal cap disposed on the proximal portion of the main body, the cap defining a cap passageway in communication with the passageway of the main body; and

at least one pull wire attached to the cap and extending into the passageway of the main body.

2. The apparatus of claim 1, wherein said delivery catheter includes a distal tip member comprising a distal tip body having a distal tip outer diameter;

and

wherein the separable connection provides a separating line on a plane that orthogonally intersects the main body passageway relative to the lengthwise axis of the main body at a point where the inner diameter of the transition chamber is greater than said distal tip outer diameter.

3. The apparatus of claim 2, wherein the proximal and distal portions of the main body define mating threads;

and

wherein the separable connection comprises a connection formed between the mating threads.

4. The apparatus of claim 1, wherein the inner sleeve has a proximal end defining a proximal detent, the proximal detent extending inwardly relative to the lengthwise axis of the main body.

5. The apparatus of claim 1, wherein the cap comprises first and second separable cap portions.

6. The apparatus of claim 5, wherein a portion of the at least one pull wire is disposed between the first and second separable cap portions.

7. The apparatus of claim 5, wherein the first and second separable cap portions define mating threads.

8. The apparatus of claim 1, wherein the proximal and distal portions of the main body define mating threads;

and

wherein the separable connection comprises a connection formed between the mating threads.

9. The apparatus of claim 1, wherein the at least one pull wire comprises a member selected from the group consisting of a thread, a string, and a suture.

10. The apparatus of claim 1, wherein the at least one pull wire comprises a stiff wire member.

11. The apparatus of claim 10, wherein the stiff wire member comprises a distal end that defines a helical structure.

12. The apparatus of claim 1, wherein the at least one pull wire comprises two or more pull wires.

13. The apparatus of claim 1, further comprises a tether wire connected to the cap and the main body.

14. The apparatus of claim 1, further comprises a distal cap disposed on the distal portion of the main body.

15. The apparatus of claim 14, wherein the distal cap seals the distal opening of the main body.

16. The apparatus of claim 15, wherein the proximal cap seals the proximal opening of the main body.

17. The apparatus of claim 16, further comprising a storage fluid disposed within the main body passageway.

18. The apparatus of claim 17, wherein said expandable intraluminal medical device has a radially-expanded configuration and a radially-compressed configuration;

and

wherein said expandable intraluminal medical device is disposed within the distal chamber of the main body passageway in said radially-expanded configuration.

19. An apparatus for loading an expandable intraluminal medical device into a delivery catheter, said apparatus comprising:

a main body having a lengthwise axis, a proximal end defining a proximal opening, a distal end defining a distal opening, and a main body passageway extending between the proximal and distal openings, the main body passageway defining a proximal chamber having a first inner diameter, a distal chamber having a second inner diameter, and a transition chamber disposed between the proximal and distal chambers, the second inner diameter being greater than the first inner diameter and the transition chamber having an inner diameter that transitions along the lengthwise axis from the second inner diameter to the first inner diameter, the main body having proximal and distal portions connected to each other at a separable connection;

an inner sleeve comprising a tubular body, a proximal detent and a distal flange, the tubular body disposed within the main body passageway, the proximal detent extending inwardly relative to the lengthwise axis of the main body, and the distal flange extending outwardly relative to the lengthwise axis of the main body and disposed between the proximal and distal portions of the main body;

a proximal cap disposed on the proximal portion of the main body, the cap comprising first and second separable cap portions and defining a cap passageway in communication with the passageway of the main body; and

at least one pull wire attached to the cap, the at least one pull wire having a first portion disposed between the first and second separable cap portions and a second portion disposed in the main body passageway.

20. A method of loading an expandable intraluminal medical device into a delivery catheter, said expandable intraluminal medical device having radially-expanded and radially-compressed configurations, said method comprising:

placing said expandable intraluminal medical device into a passageway defined by a loading apparatus such that said expandable intraluminal medical device is disposed within the passageway in said radially-expanded configuration;

pulling said expandable intraluminal medical device along an axial path and through the apparatus such that said expandable intraluminal medical device transitions from said radially-expanded configuration to said radially-compressed configuration; and

after pulling said expandable intraluminal medical device and achieving said radially-compressed configuration, pushing said expandable intraluminal medical device into said medical device delivery catheter.