Loading apparatus and system for expandable intraluminal medical devices

• US 10,596,019 B2
• Filed: 11/20/2015
• Issued: 03/24/2020
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S, Burke, Jessica L, Chambers, Sean D, Valaie, Arman
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Lauer, Christina C
• Application Number:
  US14/947,243
• Publication Number:
  US 20160074185A1
• Time in Patent Office: 1,586 Days
• 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. A medical device loading system, comprising:

a loading apparatus comprising 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 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 an axial length of the transition chamber from the second inner diameter to the first inner diameter;

a delivery catheter comprising an outer tubular member defining a sheath lumen, a dilator body disposed within the sheath lumen and defining a dilator lumen, and a distal tip member comprising an elongate cannula and a distal tip body, the elongate cannula adapted to be slideably disposed within the dilator lumen and the distal tip body defining an outer diameter that is smaller than the second inner diameter and larger than the first inner diameter; and

an expandable intraluminal medical device;

wherein the distal tip member has a separable connection that divides the distal tip member into a proximal distal tip member portion and a distal distal tip member portion when disrupted.

2. The medical device loading system of claim 1, wherein the separable connection is located on the distal tip body such that the proximal distal tip member portion includes a portion of the distal tip body and the distal distal tip member portion includes a portion of the distal tip body.

3. The medical device loading system of claim 1, wherein the distal tip body has a tapered proximal surface.

4. The medical device loading system of claim 3, wherein the separable connection is located proximal to a portion of the distal tip body defining the maximum outer diameter of the distal tip body.

5. The medical device loading system of claim 4, wherein the separable connection is located on the tapered proximal surface of the distal tip body.

6. The medical device loading system of claim 4, wherein the separable connection is located on the tapered proximal surface of the distal tip body such that entire proximal distal tip member portion can be passed through the passageway of the loading apparatus.

7. The medical device loading system of claim 1, wherein the separable connection comprises a connection formed between mating threads.

8. The medical device loading system of claim 1, wherein the main body of the loading apparatus defines a continuous outer surface.

9. The medical device loading system of claim 1, further comprising a proximal cap disposed on the proximal end of the main body, the proximal cap defining a cap passageway in communication with the passageway of the main body;

and

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

10. The medical device loading system of claim 9, wherein the at least one pull wire comprises a member selected from the group consisting of a thread, a string, and a suture.

11. The medical device loading system of claim 10, wherein the at least one pull wire comprises two or more pull wires.

12. The medical device loading system of claim 9, further comprising a distal cap disposed on the distal end of the main body.

13. The medical device loading system of claim 12, wherein the distal cap seals the distal opening of the main body.

14. The medical device loading system of claim 13, wherein the proximal cap seals the proximal opening of the main body.

15. The medical device loading system of claim 14, further comprising a storage fluid disposed within the passageway of the main body.

16. The medical device loading system of claim 15, wherein the expandable intraluminal medical device is disposed within the passageway of the main body.

17. The medical device loading system of claim 16, wherein the expandable intraluminal medical device has a radially-expanded configuration and a radially-compressed configuration;

and

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

18. A medical device loading system, comprising:

a loading apparatus comprising 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 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 an axial length of the transition chamber from the second inner diameter to the first inner diameter;

a delivery catheter comprising an outer tubular member defining a sheath lumen, a dilator body disposed within the sheath lumen and defining a dilator lumen, and a distal tip member comprising an elongate cannula and a distal tip body, the elongate cannula adapted to be slideably disposed within the dilator lumen and the distal tip body defining an outer diameter that is smaller than the second inner diameter and larger than the first inner diameter;

an expandable intraluminal medical device including a biologic component;

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

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

wherein the distal tip member has a separable connection that divides the distal tip member into a proximal distal tip member portion and a distal distal tip member portion when disrupted.

19. A medical device loading system, comprising:

a loading apparatus comprising 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 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 an axial length of the transition chamber from the second inner diameter to the first inner diameter;

a delivery catheter comprising an outer tubular member defining a sheath lumen, a dilator body disposed within the sheath lumen and defining a dilator lumen, and a distal tip member comprising an elongate cannula and a distal tip body, the elongate cannula adapted to be slideably disposed within the dilator lumen and the distal tip body defining an outer diameter that is smaller than the second inner diameter and larger than the first inner diameter;

an expandable intraluminal medical device disposed within the passageway of the main body, the expandable intraluminal medical device including a biologic component;

a proximal cap disposed on the proximal end of the main body and sealing the proximal opening;

a distal cap disposed on the distal end of the main body and sealing the distal opening;

wherein the distal tip body defines a tapered proximal surface and the distal tip member has a separable connection on the tapered proximal surface that divides the distal tip member into a proximal distal tip member portion and a distal distal tip member portion when disrupted.