Over the endoscope introducer for stents

• US 7,717,923 B2
• Filed: 11/27/2006
• Issued: 05/18/2010
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Kennedy, Kenneth C. II, Skerven, Gregory J.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US11/604,406
• Publication Number:
  US 20070123971A1
• Time in Patent Office: 1,268 Days
• Field of Search: 600/101, 600/104, 600/106, 600/121, 600/127, 600/129, 600/153, 606/108, 606/191, 606/194, 623 111- 112, 623/1.23, 604/264
• US Class Current: 606/108
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Over-the-scope stent introducers for detachably engaging at least a portion of the outside of an endoscope insert and for delivering a stent are provided. Embodiments include an inner member having a distal first end portion and a proximal second end portion and openings defining a channel. The inner member includes an outer surface, inner endoscope engaging surface, and stent abutting restraint disposed at the first end portion. Embodiments also include an outer member having a distal section and proximal section having openings defining a passageway sized to slideably receive at least a portion of the inner member, and a stent carrying inner chamber disposed at the distal section passageway and being configured to releasably contain a stent. In alternative embodiments, the inner and outer members are elongated to dispose substantially concentrically over a majority of an endoscope insert.

Claims

1. An over-the-scope stent introducer for use with an endoscope known in the art as comprising a proximal section for remaining outside a patient and an elongate flexible insert having a length sufficient to allow an insert distal end portion to reach a target site within a patient'"'"'s gastrointestinal tract, the introducer comprising:

a slideable end cap inner member useable with said endoscope insert distal end portion, the slideable end cap inner member having a distal opening at a first end portion and a proximal opening at a proximal second end portion, the openings defining a channel extending therebetween that is adapted to slideably receive said endoscope insert distal end portion such that said endoscope insert distal end portion is detachably engaged by a slideable engaging surface within the channel of the slideable end cap inner member;

a distal stent abutting restraint disposed at the first end portion of the slideable end cap inner member, the distal stent abutting restraint having a thickness at least sufficient to abut and control proximal axial movement of a stent positioned distal to the inner member such that the stent, prior to deployment, is distal to the first end portion of the end cap inner member;

a slideable end cap outer member comprising a distal section and a proximal section, openings formed at the proximal and distal sections and defining a passageway therebetween sized to slideably receive a portion of the end cap inner member and the distal stent abutting restraint, an inner chamber comprising an inner surface disposed in the passageway of the outer member distal section and being configured to releasably and circumferentially envelope the stent, and a pulling member link body;

an elongate pushing member configured to be positioned alongside said endoscope insert during use, the pushing member having a distal end in communication with the inner member and further comprising a passageway; and

an elongate pulling member configured to be positioned alongside said endoscope insert during use, the pulling member having a distal connecting end secured to the outer member pulling member link body, with the pulling member disposed at least partly within the pushing member passageway,

wherein the pulling member is configured to move the outer member proximally and telescopically over the inner member distal first end portion between a pre-deployment position and a deployment position.

2. The device of claim 1 wherein the elongate pulling member further comprises a proximal end and a flexible intermediate section.

3. The device of claim 2 wherein the elongate pulling member is configured to be slideably received in the pushing member passageway.

4. The device of claim 3 wherein the pulling member distal end is distal to the proximal end of the slideable end cap inner member in the pre-deployment position and the pulling member distal end is proximal to the slideable end cap inner member in the deployment position.

5. The device of claim 4 wherein the pulling member distal end attaches to the outside of the slideable end cap outer member.

6. The device of claim 4 wherein the pulling member comprises a wire.

7. The device of claim 2 further comprising a support body having a guide portion and a base, the guide portion having proximal and distal openings and defining a passageway that slideably receives a portion of the elongate pushing member, the base having an endoscope engaging surface.

8. The device of claim 7 wherein the flexible intermediate section of the elongate pulling member is slideably positioned within a flexible intermediate portion of the pushing member that is slideably positioned within the passageway of the support body guide portion.

9. The device of claim 1 wherein the inner member is a clipping member comprising a cutout portion extending from the first end distal opening to the second end proximal opening configured to detachably clip to said endoscope insert distal end portion.

10. The device of claim 1 wherein the stent is positioned in the outer member inner chamber.

11. The device of claim 10 wherein the stent comprises proximal and distal ends and an intermediate portion.

12. The device of claim 11 wherein the distal stent abutting restraint is sized to abut the proximal end of the stent such that the stent does not move proximally over the inner member distal end and envelope a substantial length of the endoscope slideable engaging surface of the inner member.

13. The device of claim 11 wherein the distal stent abutting restraint is sized to abut the proximal end of the stent such that the stent does not move proximally within the inner member channel and be enveloped by a substantial length of the endoscope slideable engaging surface of the inner member.

14. The device of claim 11 wherein the distal stent abutting restraint further comprises at least one protuberance, protrusion, bulge, bow, convex, bump, knob, raising, and lump sized to abut the proximal end of the stent such that the stent does not move substantially proximal to the restraint.

15. The device of claim 10 wherein the stent is positioned distal to the inner member stent abutting restraint such that the stent does not envelop the inner member first end portion and is releasably contained and circumferentially abutting the inner surface of the chamber of the outer member distal section.

16. The device of claim 10 wherein the slideable end cap inner member comprises an outer surface and the slideable end cap inner member is sized relative to the outer member passageway such that the outer surface abuts the inner surface of the inner chamber of the slideable end cap outer member such that the stent positioned in the inner chamber does not envelop a substantial length of the inner member outer surface and is further sized such that the stent is not enveloped by a substantial length of the endoscope slideable engaging surface of the inner member within the channel of the slideable end cap inner member.

17. The device of claim 16 wherein the outer member is substantially concentric to the inner member and axially slideable over the inner member received portion outer surface between a pre-deployment position and a deployment position.

18. The device of claim 1 further comprising an outer member alignment element and an inner member alignment element that slideably and detachably couple the inner member and the outer member.

19. The device of claim 18 wherein the outer member alignment element comprises a groove and the inner member alignment element comprises a guide track such that the guide track of the inner member is configured to slide within the groove of the outer member.

20. The device of claim 1 wherein the slideable end cap inner member has a length approximately that of the stent to be deployed.

21. The device of claim 1 wherein the slideable end cap outer member has a length approximately that of the stent to be deployed.

22. The device of claim 1 wherein the distal opening of the slideable end cap outer member is distal to the distal opening of the slideable end cap inner member in the pre-deployment position.

23. A system for introducing a stent, the system comprising:

an endoscope comprising a proximal section, an elongate flexible insert, and an insert distal end portion having an endoscope insert outer periphery;

a slideable end cap inner member comprising a distal opening at a first end portion and a proximal opening at a proximal second end portion, the openings defining a channel extending therebetween, the endoscope insert distal end portion being at least partially inserted into the channel such that the endoscope insert outer periphery is detachably coupled by a slideable engaging surface within the channel of the slideable end cap inner member;

a distal stent abutting restraint disposed at the first end portion of the slideable end cap inner member;

a slideable end cap outer member having a distal section and a proximal section, openings formed at the proximal and distal sections and defining a passageway therebetween sized to slideably receive a portion of the end cap inner member and the distal stent abutting restraint, an inner chamber comprising an inner surface disposed in the passageway of the outer member distal section, and a pulling member link body;

an elongate pushing member configured to be positioned alongside said endoscope insert during use, the pushing member having a distal end in communication with the inner member and further comprising a passageway; and

an elongate pulling member configured to be positioned alongside said endoscope insert during use, the pulling member having a distal connecting end secured to the outer member pulling member link body, with the pulling member disposed at least partially within the pushing member passageway,

wherein the pulling member is configured to move the outer member proximally and telescopically over the inner member distal first end portion between a pre-deployment position and a deployment position.

24. The system of claim 23 further comprising an outer surface disposed circumferentially about the slideable end cap inner member.

25. The system of claim 24 wherein the outer member is substantially concentric to the inner member and axially slideable over the inner member received portion outer surface between a pre-deployment position and a deployment position.

26. The system of claim 25 further comprising a stent, the stent comprising proximal and distal ends and an intermediate portion, at least the stent proximal end being positioned in the outer member inner chamber distal to the distal stent abutting restraint of the inner member such that, prior to deployment, the stent does not envelop a substantial length of the inner member outer surface and is not enveloped by a substantial length of the endoscope slideable engaging surface of the inner member.

27. The system of claim 26 wherein the outer member inner chamber is configured to releasably and circumferentially envelope said stent.

28. The system of claim 27 wherein the pushing member has sufficient stiffness to urge the inner member and distal stent abutting restraint distally so as to substantially inhibit the stent from moving proximally when the slideable end cap outer member moves proximally over the stent between the pre-deployment position and the deployment position.

29. The system of claim 26 wherein the distal stent abutting restraint has a thickness substantially that of the first end portion of the slideable end cap inner member and is configured to control proximal axial movement of the stent.

30. The system of claim 23 further comprising a support body having a guide portion and a base, the guide portion having proximal and distal openings and defining a passageway that slideably receives a portion of the elongate pushing member, the base having an endoscope engaging surface.

31. The system of claim 23 wherein the elongate pushing member further comprises a proximal end and a flexible intermediate section, the flexible intermediate section further comprises a proximal retractor end and a flexible intermediate portion disposed at least partly within the pushing member passageway.

32. The system of claim 23 wherein the endoscope is selected from the group consisting of a choledoschoscope, colonoscope, duodenoscope, echoendoscope, enteroscope, gastroscope, and sigmoidoscope.