System and method for introducing multiple medical devices

• US 20050059990A1
• Filed: 07/29/2004
• Published: 03/17/2005
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Skerven, Gregory J., Agnew, Charles, Ayala, Juan Carlos, Deal, Stephen E.
• Granted Patent: US 7,967,830 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A method and apparatus for introducing a first elongate medical device and short wire guide that are coupled together into a work site and remotely disconnecting them within the work site such that a secondary device comprising a catheter member can be introduced over the wire guide to the work site, and/or a second wire guide can be introduced to the work site via a passageway of the primary access device. A separating member may be provided to remotely separate the wire guide from the elongate medical device. A system of indicia, such as radiopaque or viewable markers, permits the operator to monitor the relative alignment of the devices within the work site to determine when uncoupling has occurred. In one example of the method, a wire guide and primary access device (e.g., a sphincterotome) is coupled to the wire guide and introduced via a duodenoscope into the biliary system. After performing a first medical operation, the devices are uncoupled with the wire guide being left within the biliary system such that a secondary access device, such as a balloon, biopsy device, stent delivery catheter, dilator, etc., can be introduced to perform a second medical operation without a traditional over-the-wire exchange being required. In another example of the method, a prosthesis, such as a valve or stent, is placed within the work site coupled to a wire guide which is remotely disconnected within the work site and a secondary device, such as a dilation balloon or second prosthesis, is introduced into the work site after the first delivery system is removed.

Claims

1. A system for introducing multiple medical devices into a work site within a bodily lumen of a patient comprising:

an elongate medical device comprising a shaft extending between a distal end and a proximal end, a lumen extending through at least a portion of the shaft, the lumen comprising a coupling region extending between a distal opening and a proximal opening;

a wire guide having a distal end and a proximal end; and

a separating member,

wherein the wire guide is movable from a coupled position to an uncoupled position while maintaining the distal end of the elongate medical device and the distal end of the wire guide within the bodily lumen of the patient, the wire guide extending through the coupling region of the elongated medical device when in the coupled position, the wire guide not extending through the coupling region of the elongated medical device when in the uncoupled position, and

wherein the separating member is configured to engage and move the wire guide from the coupled position to the uncoupled position.

2. The system of claim 1, wherein the separating member comprises an elongate member slidably engaged with the shaft of the elongate medical device, wherein proximal movement of the elongate member relative to the elongate medical device engages and moves the wire guide from the coupled position to the uncoupled position.

3. The system of claim 2, wherein the elongate member is slidably disposed through the lumen of the elongate medical device.

4. The system of claim 3, wherein the elongate member comprises a distal end configured to engage a portion of the wire guide disposed within the lumen of the coupling region, further wherein the proximal movement of the elongate member relative to the elongate medical device forces the wire guide out of the lumen and through a side wall of the shaft.

5. The system of claim 4, wherein the side wall of the shaft adjacent to the coupling region comprises one of an open channel, a split, a score, a perforation, a reduced cross-section, and a relatively weak material to facilitate movement of the wire guide therethrough.

6. The system of claim 4, wherein the separating member comprises a second wire guide.

7. The system of claim 2, wherein the elongate member is slidably disposed about the shaft of the elongate medical device.

8. The system of claim 7, wherein the elongate member comprises a distal end configured to engage a portion of the wire guide exiting out from the proximal opening of the elongate medical device, further wherein the proximal movement of the elongate member relative to the elongate medical device forces the wire guide out of the lumen and through a side wall of the shaft.

9. The system of claim 8, wherein the side wall of the shaft adjacent to the coupling region comprises one of an open channel, a split, a score, a perforation, a reduced cross-section, and a relatively weak material to facilitate movement of the wire guide therethrough.

10. The system of claim 1, wherein the separating member comprises a tether having a loop on one end thereof, the tether extending through the distal opening and into the lumen of the elongate medical device, wherein proximal movement of the tether through the lumen of the elongate medical device moves the wire guide from the coupled position to the uncoupled position.

11. The system of claim 10, wherein the loop is slidably engaged with the shaft of the elongate medical device and engages a portion of the wire guide exiting out from the proximal opening of the elongate medical device.

12. The system of claim 10, wherein the loop is disposed about a portion of the wire guide exiting out from the proximal opening of the elongate medical device.

13. The system of claim 10, wherein the side wall of the shaft adjacent to the coupling region comprises one of an open channel, a split, a score, a perforation, a reduced cross-section, and a relatively weak material to facilitate movement of the wire guide therethrough.

14. The system of claim 1, wherein the elongate medical device comprises a balloon catheter having an inflatable balloon disposed on a proximal portion thereof.

15. The system of claim 14, wherein the inflatable balloon comprises a groove adjacent to the coupling region of the shaft to facilitate movement of the wire guide therethrough.

16. The system of claim 1, wherein the elongate medical device comprises a prosthesis delivery system, further, wherein proximal movement of the separating member relative to the prosthesis delivery system results in deployment of a prosthesis mounted on the prosthesis delivery system.

17. The system of claim 15, wherein deployment of the prosthesis occurs substantially simultaneously with movement of the wire guide from the coupled position to the uncoupled position.

18. The system of claim 15, wherein the a prosthesis delivery system comprises an inner stent support member, and the separating member comprises an outer sheath member slidably disposed over the inner stent support member, the outer sheath member configured to enclose and maintain a self-expanding stent in a contracted delivery configuration until deployed by the prosthesis delivery system.

19. A method for introducing multiple medical devices into a work site within a bodily lumen of a patient comprising the steps of:

a) providing an elongate medical device comprising a shaft extending between a distal end and a proximal end, a lumen extending through at least a portion of the shaft, the lumen comprising a coupling region extending between a distal opening and a proximal opening;

b) providing a wire guide having a distal end and a proximal end;

c) providing a separating member;

d) extending the wire guide through the coupling region of the elongate medical device;

e) positioning the distal end of the wire guide and the distal end of the elongate medical device within the work site of the patient;

f) advancing the separating member along the elongate medical device so as to engage the wire guide at a location near the coupling region; and

g) advancing the separating member in a proximal direction relative to the elongate member so as to remove the wire guide from the coupling region.

20. The method of claim 19, wherein the separating member comprises an elongate member having a distal end, and step f) comprises the step of advancing the elongate member through the lumen of the elongate medical device so as to engage the wire guide with the distal end of the elongate member.