Over the endoscope introducer for stents

• US 20070123971A1
• Filed: 11/27/2006
• Published: 05/31/2007
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Kennedy, Kenneth, Skerven, Gregory
• Granted Patent: US 7,717,923 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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, comprising:

an elongate tubular inner member having a distal first end portion, a proximal second end portion, and a flexible intermediate portion, openings formed at the first and second end portions and defining a channel therebetween configured to slidably receive an endoscope insert and comprising an inner endoscope insert engaging surface, an outer surface disposed circumferentially about the inner member, a stent abutting restraint positioned at the distal first end portion, and a pusher positioned at the proximal second end portion in communication with the stent abutting restraint; and

an elongate tubular outer member having a distal section, a proximal section, and a flexible middle section, openings formed at the proximal and distal sections and defining a passageway therebetween sized to slideably receive a portion of the inner member, the outer member being substantially concentric to the inner member and axially slideable over the inner member portion outer surface, an inner chamber disposed in the passageway of the outer member distal section and being configured to releasably contain a stent, and a puller disposed at the outer member proximal section and being configured to move the outer member distal section inner chamber between a pre-deployment position and a deployment position.

2. The device of claim 1 wherein the inner member pusher has sufficient stiffness to urge the inner member distal first end portion distally and keep the stent abutting restraint from prolapse as a result of the outer member inner chamber being pulled proximally over the inner member distal first end portion.

3. The device of claim 1 further comprising a latching member detachably operatively coupling the outer member proximal section and the inner member second end portion outer surface.

4. The device of claim 1 further comprising a second latching member configured to detachably operatively couple the inner member second end portion and an endoscope insert proximal section.

5. The device of claim 1 wherein the inner member endoscope insert engaging surface is a slideably engageable surface configured to dispose substantially concentrically over a majority of an endoscope insert.

6. The device of claim 1 wherein the inner member endoscope insert engaging surface is configured to dispose substantially concentrically over a majority of an endoscope insert and comprise a friction fit engagement sufficient to detachably operatively the inner member endoscope insert engaging surface and the endoscope insert.

7. The device of claim 1 further comprising an endoscope comprising an elongate endoscope insert having an insert distal end and an insert proximal section, the insert distal end having a longitudinal axis.

8. The device of claim 7 further comprising a stent.

9. The device of claim 8 wherein the stent is disposed circumferentially about the endoscope insert distal end and longitudinal axis.

10. The device of claim 8 further comprising a stent disposed offset to the endoscope insert distal end and the longitudinal axis.

11. An over-the-scope stent introducer, comprising:

a 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 configured to slidably receive an endoscope insert and comprising an inner endoscope slideable engaging surface, an outer surface disposed circumferentially about the inner member, and a stent abutting restraint disposed at the first end portion;

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 inner member, an inner chamber disposed in the passageway of the outer member distal section and being configured to releasably contain a stent, the outer member being 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, and the outer member further having a pulling member link body; and

an elongate pulling member comprising a proximal retractor end, a flexible intermediate portion, and a distal connecting end secured to the outer member pulling member link body,

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

12. The device of claim 11 further comprising an elongate pushing member configured to be disposed external to an endoscope insert and having a proximal end, a flexible intermediate section, and a distal end in communication with the inner member, the pushing member having a pulling member receiving passageway.

13. The device of claim 12 wherein the elongate pulling member is configured to be slideably received in the pushing member passageway such that both the pulling member and pushing member are configured to be disposed external to an endoscope insert, with the pulling member disposed at least partly within the pushing member passageway.

14. The device of claim 12 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 slidably receives a portion of the elongate pushing member, the base having an endoscope engaging surface.

15. The device of claim 11 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 an endoscope insert outer periphery.

16. The device of claim 11 further comprising a stent positioned in the outer member inner chamber.

17. The device of claim 11 further comprising an endoscope comprising an elongate endoscope insert having an insert distal end and an insert proximal section, the insert distal end having a longitudinal axis.

18. The device of claim 17 further comprising a stent disposed circumferentially about the endoscope insert distal end and longitudinal axis.

19. The device of claim 17 wherein the endoscope further comprises a distal side port and a working channel, the elongate pulling member flexible intermediate portion being slideably received in the side port and extending proximally through the working channel.

20. The device of claim 11 further comprising an outer member alignment element and an inner member alignment element slidably detachably couple the inner member and the outer member.

21. A method of using an over-the-scope stent introducer, comprising the steps of:

providing an inner member having first and second end portions with openings defining an endoscope receiving channel such that the inner member is configured to concentrically slidably fit over an endoscope insert wherein the second end portion comprises a stent abutting restraint, an outer member having distal and proximal sections defining a passageway sized to concentrically slidably fit over at least a portion of the inner member and having a stent carrying inner chamber disposed in the passageway of the distal section configured to releasably contain a stent, an elongate pulling member in communication with the outer member and an elongate pushing member in communication with the inner member;

disposing the outer member over at least the portion of the inner member slidably fitting within the outer member passageway;

pushing on the pushing member to urge the inner member distal first end portion distally and keep the stent abutting restraint from prolapse that might result from the outer member being pulled proximally over the inner member distal first end portion; and

retracting the pulling member proximally to move the outer member proximally over the inner member between a pre-deployment position and a deployment position.

22. The method of claim 21 further comprising the step of lubricating the outer member.

23. The method of claim 21 further comprising the step of preloading a stent within the outer member chamber and restrained from proximal movement by the stent abutting restraint.

24. The method of claim 21 further comprising the step of providing an endoscope comprising an elongate endoscope insert having an insert distal end and an insert proximal section, the insert distal end having a longitudinal axis.

25. The method of claim 24 further comprising the step of loading a stent circumferentially about the endoscope insert distal end and longitudinal axis.

26. The method of claim 24 further comprising the step of inserting at least the endoscope insert distal end within the inner member channel.

27. The method of claim 24 further comprising the steps of advancing the endoscope insert distal end through the anus and rectum and colon to a target site for stent deployment within a patient.

28. The method of claim 21 further comprising the steps of disposing the elongate pushing member external to an endoscope insert, the pushing member having a pulling member receiving passageway, and inserting the elongate pulling member within the pushing member passageway such the pulling and pushing members are disposed external to an endoscope insert, with the pulling member disposed at least partly within the pushing member passageway.

29. The method of claim 21 further comprising the step of detachably operatively coupling the outer member and the inner member.