System and method for introducing multiple medical devices

• US 8,206,320 B2
• Filed: 07/29/2004
• Issued: 06/26/2012
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Deal, Stephen E., Carter, Matthew P., Clark, Victor D. Jr., Haller, Frederick B., Hardin, David M. Jr., Karpiel, John A., Kennedy, Kenneth C. II, Rucker, Brian K., Skerven, Gregory J., Waller, David F.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US10/902,625
• Publication Number:
  US 20050059890A1
• Time in Patent Office: 2,889 Days
• Field of Search: 600/585
• US Class Current: 600/585
• 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 system of indicia, such as radiopaque or viewable markers, permit 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 method of introducing multiple medical devices into a work site within a bodily lumen of a patient, comprising the steps of:

a. advancing both a guiding member and a first elongate medical device, each having a distal end, a distal portion, and a proximal portion, into the work site to perform a first medical operation such that the distal ends of the guiding member and the first elongate medical device are positioned within the work site while maintaining the proximal portions of the guiding member and the first elongate medical device external to the patient, the first elongate medical device engaging the guiding member along a coupling region having a first end and a second end located proximal thereto, the coupling region being located about the distal portion of the first elongate medical device;

b. longitudinally advancing the first elongate medical device relative to the guiding member in a controlled manner until it can be determined that the guiding member has disengaged from the coupling region of the elongate medical device such that the guiding member and the first elongate medical device are uncoupled from one another while remaining within the work site;

c. coupling a third elongate medical device to one of the guiding member and the first elongate medical device; and

d. advancing the third elongate medical device to the work site,

wherein the guiding member and the first elongate medical device include an alignment indication system configured for use by the operator to determine when the guiding member and the first elongate medical device have uncoupled from one another within the work site, the alignment indication system comprising a first proximal indicator located about the proximal portion of the guiding member and a second proximal indicator located about the proximal portion of the first elongate medical device, the first and second proximal indicators configured to be spaced relative to one another during the first medical operation to indicate that uncoupling of the guiding member and the first elongate medical device within the work site is at least imminent, the first and second proximal indicators configured to remain external to the patient during the first medical operation; and

wherein the method further comprises the step of visually monitoring the alignment indication system externally of the patient until the first and second proximal indicators are substantially aligned to thereby indicate that uncoupling of the guiding member and the first elongate medical device has occurred within the work site.

2. The method of claim 1, wherein the guiding member comprises a wire guide, and further comprising the step of removing the first elongate medical device from the patient following disengagement from the wire guide.

3. The method of claim 2, wherein the alignment indication system further comprises first and second distal indicators comprising imageable markers, the method further comprising the step of monitoring the first and second distal indicators using an external imaging system to determine their relative position to one another within the work site.

4. The method of claim 3, wherein the distal end of the wire guide comprises the first distal indicator and the second distal indicator comprises a band located proximate the second end of the coupling region.

5. The method of claim 3, wherein the first and second distal indicators comprise a radiopaque material.

6. The method of claim 3, wherein the first and second distal indicators comprise an ultrasonically reflective surface.

7. The method of claim 2, wherein the coupling region comprises a passageway extending at least partially through the distal portion of the first elongate medical device, a first opening located about the distal end thereof, and a second opening comprising a side access port communicating with the passageway and located proximal to the first opening, the coupling region configured such that wire guide is coupled to the first elongate medical device while the distal portion of the wire guide at least partially resides within the passageway such that the distal end of the wire guide extends at least near to the first opening of the first elongate medical device while the proximal portion of the wire guide extends proximally from the second opening.

8. The method of claim 7, wherein the first elongate medical device comprises a first tubular member that includes a passageway extending from at least the coupling region thereof proximal to the proximal portion, wherein the third elongate medical device comprises a second wire guide.

9. The method of claim 8, further comprising the steps of feeding the distal end of the second wire guide into a proximal side access port located about the proximal portion of the first catheter and advancing the second wire guide through the passageway until the distal end thereof resides within the work site.

10. The method of claim 9, wherein the first tubular member is configured to allow the second wire guide, when disposed in the passageway of the first tubular member to laterally exit via a side wall thereof, the method further comprising the step of disengaging the second wire guide from the passageway of the first tubular member by laterally exiting the side wall thereof between the side access port and the proximal side access port.

11. The method of claim 10, wherein the side wall of the first member comprises at least one of an open channel or self-sealing seam.

12. The method of claim 10, further comprising the step of removing the second wire guide from the passageway through a splittable region within the side wall located between the side access port and the proximal side access port until the second wire guide is completely removed from the passageway such that the first and second wire guides remain indwelling at the work site and each is configured to receive a fourth elongate medical device coupled thereover.

13. The method of claim 12, further comprising the step of advancing a fifth elongate medical device over the second wire guide to the work site.

14. The method of claim 12, wherein the splittable region comprises a weakened portion of the wall in which material has been removed such that the wall is predisposed to split apart when force is applied thereto.

15. The method of claim 12, wherein the splittable region comprises a portion of the wall configured to split or tear apart when sufficient force is applied thereto.

16. The method of claim 15 wherein the tubular member comprises a first material with the portion of the wall configured to split or tear apart comprising a second material adapted to split or tear apart with less force than that required for splitting the first material.

17. The method of claim 2, wherein the third elongate medical device comprising a tubular member having a coupling region, the coupling region configured to engage the wire guide, wherein the tubular member is advanced over the wire guide to the work site after the wire guide is uncoupled from the tubular member.

18. The method of claim 17, wherein the tubular member includes a passageway extending at least from the first end of the coupling region, proximally to the second end of the coupling region, the second end comprising a side access port traversing the side wall of the tubular member.

19. The method of claim 18, wherein the third elongate medical device is advanced to the work site by inserting the proximal end of the wire guide into the first end of the coupling region located about the distal end of the tubular member, advancing the proximal end of the wire guide through the passageway until it exits the side access port, then advancing the tubular member over the wire guide to the work site.

20. The method of claim 8, further including the steps of introducing a fourth elongate medical device over the proximal end of the second wire guide;

advancing the fourth elongate medical device to the work site performing a medical operation and removing the fourth elongate medical device from the patient, wherein the second wire guide is sized such that the proximal portion thereof extending out of the patient is of sufficient length such that the fourth medical device is removable over the proximal portion while the operator or assistant thereto retains longitudinal control over the proximal end of the second wire guide.

21. The method of claim 2, wherein the wire guide is introduced to the work site coupled to an endoscope such that the wire guide remains at least substantially external thereto, wherein the wire guide is uncoupled from the endoscope and the first elongate medical device is then introduced over the wire guide and advanced to the work site.

22. The method of claim 2, wherein the third elongate medical device is advanced to the work site to perform a second medical operation, the second medical operation being of a different type than the first medical operation.

23. The method of claim 2, wherein the wire guide slidably and releasably engages the first elongate medical device along the coupling region.

24. The method of claim 2, wherein the wire guide is releasably secured to the first elongate medical device within the coupling region thereof during advancement of the first elongate medical device to the work site.

25. The method of claim 24, wherein the first elongate medical device comprises a tubular member having a passageway extending at least substantially therethrough, the distal portion thereof further comprising the coupling region that includes a distal opening and side access port, the method further comprising the steps of maintaining an elongate engagement member within the passageway that is configured to engage the wire guide coupled therein in manner that limits longitudinal movement of the wire guide relative to the first elongate medical device, then manipulating the elongate member to disengage the wire guide and first elongate medical device.

26. The method of claim 25, wherein the elongate engagement member comprises a stylet sized configured to frictionally engage the wire guide about the side access port to limit relative movement between the wire guide and first elongate medical device, the first stylet and first elongate member configured such that the wire guide is released upon at least the partial withdrawal of the first stylet with the passageway.

27. The method of claim 25, wherein the elongate engagement member comprises a tether configured to releasably engage the wire guide within the passageway.

28. The method of claim 2, further comprising the step of releasably securing the proximal portion of the wire guide to a wire guide engagement mechanism located external to the patient such that longitudinal movement of the wire guide is substantially restricted.

29. The method of claim 2, wherein the method further includes the step of introducing the first elongate medical device and the wire guide through an endoscope toward the work site.

30. The method of claim 2, wherein the work site comprises at least one of the common bile duct, the pancreatic duct, the liver, the intestines, the stomach, and the esophagus.

31. The method of claim 1, wherein the work site is located within the vascular system.

32. The method of claim 1, wherein the work site is located within the genito-urinary system.

33. The method of claim 1, wherein the work site comprises the pulmonary system.

34. The method of claim 2, wherein the coupling region comprises at least one of an external channel or ring attached about the distal portion of first elongate medical device.

35. The method of claim 7, wherein at least one of the first elongate medical device and the third elongate medical device includes a stiffening member disposed within the passageway thereof and at least partially longitudinally traversing the side access port, the stiffening member configured to be removable from the passageway.

36. The method of claim 1, wherein the guiding member comprises a first wire guide and the first elongate medical device comprises a second wire guide having the coupling region attached thereto.

37. The method of claim 2, wherein the alignment indication system further comprises a first intermediate indicator and a second intermediate indicator that are both located about intermediate portions of the wire guide and the first elongate medical device, respectively, the first and second intermediate indicators being generally viewable by an endoscope when the wire guide and first elongate medical device are positioned with the work site.

38. The method of claim 2, wherein the wire guide and first elongate medical device are configuared to provide tactile feedback to the operator for indicating that uncoupling between the wire guide and the first elongate medical device is at least imminent with further relative repositioning therebetween.

39. The method of claim 38, where the tactile feedback is supplied by a first structure located about the wire guide that is configured to encounter resistance against a second structure located about the first elongate medical device as the wire guide exits the coupling region, the resistance being discernable by the operator.

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

a. advancing both a wire guide and a first tubular member, each having a distal end, a distal portion, and a proximal portion having a visual indicia disposed thereon, into the work site to perform a first medical operation such that the distal ends of the wire guide and the first elongate medical device are positioned within the work site while maintaining the proximal portions and the visual indicia of the wire guide and the first tubular member external to the patient, the first tubular member including a passageway extending at least partially therethrough, the distal portion thereof comprising a coupling region configured to receive and engage the wire guide therein, the coupling region having a first end and a second end, the second end comprising a side access port traversing a wall of the tubular member;

b. longitudinally advancing the first tubular member relative to the wire guide until the operator has determined, by monitoring the position of the visual indicia of the wire guide relative to the visual indicia of the first tubular member, that the distal end of the wire guide has disengaged from the coupling region through the side access port such that the wire guide and the first elongate medical device are uncoupled from one another while remaining within the work site;

c. coupling a second tubular member to the wire guide; and

d. advancing the second tubular member along the wire guide to the work site.

41. A method of introducing a medical device into a work site within a bodily lumen of a patient, comprising the steps of:

a. introducing a wire guide having a distal end into the bodily lumen until the distal end is positioned within a biliary system of the patient;

b. advancing a first elongate medical device having a distal end, a passageway, and a side access port over the wire guide and into the biliary system to perform a first medical operation, wherein a substantial portion of the wire guide extends proximally out of passageway via the side access port, the side access port being located about the distal portion of the elongate medical device and communicating with the passageway thereof;

c. monitoring indicia located about both the wire guide and the first elongate medical device to determine the position of the distal end of the wire guide relative to the side access port, the indicia being disposed on proximal portions of each of the wire guide and the first elongate member such that the indicia remain external to the patient while the distal ends of the wire guide and the first elongate medical device are disposed within the work site;

d. longitudinally withdrawing the wire guide in a proximal direction relative to the first elongate medical device until it can be determined by direct visual observation of the indicia that the wire guide has disengaged from the passageway of the first elongate medical device such that the wire guide and the first elongate medical device are uncoupled while remaining within the work site;

e. coupling a third elongate medical device to the wire guide or first elongate medical device via a second coupling region located on one of the first elongate medical device or third elongate medical device; and

f. advancing the third elongate medical device to the work site.