SYSTEM AND METHOD FOR INTRODUCING MULTIPLE MEDICAL DEVICES

• US 20110087234A1
• Filed: 12/20/2010
• Published: 04/14/2011
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles, Ayala, Juan Carlos, Deal, Stephen E., Skerven, Gregory J.
• Granted Patent: US 8,512,389 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• 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. An elongate medical device for introducing multiple members into a work site within a bodily lumen of a patient comprising:

an elongate flexible 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 defined between a distal opening and a proximal opening each disposed through a side wall of the shaft, the distal opening being disposed proximate to or upon the distal end of the shaft, the proximal opening being disposed a substantial distance from the proximal end of the shaft and a relatively shorter distance from the distal end of the shaft, wherein each of the distal and proximal openings are configured to pass an elongate wire guide therethrough;

an elongate separating member disposed coaxially with the shaft and slidably mounted about an outer surface of the shaft,

wherein a portion of the wire guide may be disposed within the lumen with opposite ends of the portion of the wire guide extending through the respective distal and proximal openings when in a coupled configuration, and may be transferred to an uncoupled configuration where the wireguide is withdrawn from the lumen and through the coupling region while maintaining the distal end of the shaft and the distal end of the wire guide within the bodily lumen of the patient,

wherein the separating member is configured to engage and move the wire guide laterally from the coupled configuration to the uncoupled configuration while maintaining the distal end of the shaft and the distal end of the wire guide within the bodily lumen of the patient and without substantially changing the longitudinal position of the wire guide relative to the shaft; and

wherein the separating member is configured to engage and move the wire guide laterally from the coupled configuration to the uncoupled configuration without extending into the lumen of the shaft.

2. The device of claim 1, wherein the separating member comprises a tubular member slidably engaged with the shaft, wherein proximal distal movement of the tubular member relative to the shaft engages a portion of the wire guide extending out of the proximal opening and urges movement of the wire guide from the coupled configuration to the uncoupled configuration.

3. The device of claim 2, wherein the tubular member comprises a distal end configured to engage a portion of the wire guide extending from the shaft through the proximal opening, wherein distal movement of the tubular member relative to the shaft urges the wire guide out of the lumen and through the coupling region.

4. The device of claim 1, wherein the side wall of the shaft within 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 laterally therethrough.

5. The device of claim 1, wherein the shaft comprises a balloon catheter having an inflatable balloon disposed on a distal portion thereof.

6. The device of claim 5, wherein the inflatable balloon comprises a groove adjacent to the coupling region of the shaft to facilitate movement of the wire guide therethrough.

7. The device of claim 1, wherein shaft comprises a prosthesis delivery system, further wherein distal movement of the separating member relative to the prosthesis delivery system results in deployment of a prosthesis mounted on the prosthesis delivery system.

8. The device of claim 7, wherein deployment of the prosthesis occurs substantially simultaneously with lateral movement of the wire guide from the coupled configuration to the uncoupled configuration.

9. 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 between a distal opening in the distal end of the shaft and a proximal port near the proximal end of the shaft, the lumen comprising a coupling region defined between a the distal opening and a proximal opening each disposed through a side wall of the shaft, the proximal opening being disposed closer to the distal opening than the proximal port;

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

c) providing an elongate separating member slidably mounted about an outer surface of the shaft;

d) extending the wire guide through the proximal opening, the coupling region, and the distal opening of the shaft;

e) positioning the distal end of the wire guide and the distal end of the shaft within the work site of the patient;

f) advancing the separating member along the shaft so as to engage a portion of the wire guide extending from the lumen through the proximal opening; and

g) advancing the separating member in a distal direction relative to the shaft so as to laterally remove the wire guide from the coupling region while maintaining the distal end of the wire guide and the distal end of the shaft within the work site of the patient and without substantially changing the longitudinal position of the wire guide relative to the shaft.

10. The method of claim 9, wherein the separating does not extend through the side wall of the shaft and into the lumen when engaging the wire guide.

11. 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 defined between a distal opening and a proximal opening each disposed through a side wall of the shaft, the distal opening being disposed proximate to or upon the distal end of the shaft, the proximal opening being disposed a substantial distance from the proximal end of the shaft and a relatively shorter distance from the distal end of the shaft;

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

an elongate separating member disposed coaxially with the shaft and slidably mounted about an outer surface of the shaft,

wherein a portion of the wire guide may be disposed within the lumen with opposite ends of the portion of the wire guide extending through the respective distal and proximal openings when in a coupled configuration, and may be transferred to an uncoupled configuration where the wireguide is withdrawn from the lumen and through the coupling region while maintaining the distal end of the shaft and the distal end of the wire guide within the bodily lumen of the patient,

wherein the separating member is configured to engage and move the wire guide laterally from the coupled configuration to the uncoupled configuration while maintaining the distal end of the shaft and the distal end of the wire guide within the bodily lumen of the patient and without substantially changing the longitudinal position of the wire guide relative to the shaft; and

wherein the separating member is configured to engage and move the wire guide laterally from the coupled configuration to the uncoupled configuration without extending into the lumen of the shaft.

12. The system of claim 11, wherein the separating member comprises a tubular member slidably engaged with the shaft, wherein proximal distal movement of the tubular member relative to the shaft engages a portion of the wire guide extending out of the proximal opening and urges movement of the wire guide from the coupled configuration to the uncoupled configuration.

13. The system of claim 12, wherein the tubular member comprises a distal end configured to engage a portion of the wire guide extending from the shaft through the proximal opening, wherein distal movement of the tubular member relative to the shaft urges the wire guide out of the lumen and through the coupling region.

14. The system of claim 11, wherein the side wall of the shaft within 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 laterally therethrough.

15. The system of claim 11, wherein the elongate medical device comprises a balloon catheter having an inflatable balloon disposed on a proximal distal portion thereof.

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

17. The system of claim 11, wherein the elongate medical device comprises a prosthesis delivery system, wherein distal movement of the separating member relative to the prosthesis delivery system results in deployment of a prosthesis mounted on the prosthesis delivery system.

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

19. The system of claim 17, 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.