System and method for introducing multiple medical devices

• US 20050059890A1
• 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: Wislon-Cook Medical Incorporated
• Inventors: Clark, Victor D. Jr., Kennedy, Kenneth C. II, Hardin, David M. Jr., Deal, Stephen E., Karpiel, John A., Skerven, Gregory J., Rucker, Brian K., Waller, David F., Carter, Matthew P., Haller, Frederick B.
• Granted Patent: US 8,206,320 B2
• Time in Patent Office: Days
• US Class Current: 600/433
• 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 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, 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. repositioning at least one of the guiding member and first elongate medical device relative to the other in a controlled manner until it can be determined that the guiding member has disengaged from the coupling region 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.

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

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

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

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

2. The method of claim 2, 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 wire guide and the first elongate medical device include an alignment indication system configured for use by the operator to determine when the wire guide and first elongate medical device have uncoupled from one another within the work site.

4. The method of claim 3, further comprising the step of monitoring the alignment indication system to determine the position of the distal end of the wire guide relative to the coupling region.

5. The method of claim 3, wherein the alignment indication system comprises a first indicator located about the wire guide and a second indicator located about the elongate medical device such that the alignment thereof is indicative of the distal end of the wire guide being substantially aligned with the second end of the coupling region such that uncoupling within the work site is at least imminent with further relative repositioning.

6. The method of claim 5, wherein the substantial alignment of the first and second indicators is indicative that uncoupling has occurred within the work site.

7. The method of claim 5, wherein the first and second indicators comprise imageable markers, the method further comprising the step of monitoring the first and second indicators using a external imaging system to determine their relative position to one another within the work site.

8. The method of claim 7, wherein the distal end of the wire guide comprises the first indicator and the second indicator comprises a band located proximate the second end of the coupling region.

9. The method of claim 7, wherein the first and second indicators comprise a radiopaque material.

10. The method of claim 7, wherein the first and second indicators comprise an ultrasonically reflective surface.

11. 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.

12. The method of claim 11, 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.

13. The method of claim 12, 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.

14. The method of claim 13, 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.

15. The method of claim 14, wherein the splittable region comprises at least one of an open channel or self-sealing seam.

16. The method of claim 14, 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.

17. The method of claim 16, further comprising the step of advancing a fifth elongate medical device over the second wire guide to the work site.

18. The method of claim 16, 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.

19. The method of claim 16, wherein the splittable region comprises a portion of the wall configured to split or tear apart when sufficient force is applied thereto.

20. The method of claim 19, 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.

21. The method of claim 2, wherein the third elongate medical device comprises 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.

22. The method of claim 21, 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.

23. The method of claim 22, 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.

24. The method of claim 12, 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 an assistant thereto retains longitudinal control over the proximal end of the second wire guide.

25. 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.

26. 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.

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

28. 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.

29. The method of claim 28, 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.

30. The method of claim 29, 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 stylet and first elongate member configured such that the wire guide is released upon at least the partial withdrawal of the first stylet within the passageway.

31. The method of claim 29, wherein the elongate engagement member comprises a tether configured to releasably engage the wire guide within the passageway.

32. The method of claim 3, wherein the alignment indication system comprises at least a first proximal indicator located about the proximal portion of at least one of the wire guide and the first elongate medical device, the first proximal indicator configured such that the alignment thereof with a reference point located about the proximal portion of the corresponding other of the wire guide or first elongate medical device is indicative that uncoupling of the wire guide and first elongate medical device within the work site is at least imminent with further relative repositioning.

33. The method of claim 32, where the wire guide includes a first indicator and the first elongate medical device includes a second indicator, the first and second indicators configured to be spaced at a relative distance from one another during the first medical operation, the method further comprising the step of monitoring the indicia until the first and second indicators are substantially aligned, indicating that uncoupling of the wire guide and first elongate medical device has occurred within the work site.

34. 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.

35. 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.

36. 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.

40. 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.

41. The method of claim 11, 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.

43. The method of claim 5, wherein the first indicator and the second indicator are both located about intermediate portions of the wire guide and the first elongate medical device, respectively, the first and second indicators being generally viewable by an endoscope when the wire guide and first elongate medical device are positioned within the work site.

44. The method of claim 3, wherein the wire guide and first elongate medical device are configured 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.

45. The method of claim 44, 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 discemable by the operator.

70. The method of claim 44, wherein the wire guide is releasably secured to the first elongate medical device during advancement of first elongate medical device to the work site.

71. The method of claim 70, wherein the first elongate medical device comprises a passageway extending substantially therethrough that includes the coupling region, the method further comprises the steps of maintaining an elongate engagement member within the passageway that is configured to engage the wire guide disposed within the coupling region to limit longitudinal movement of the wire guide relative to the first elongate medical device;

and manipulating the elongate engagement member to disengage the wire guide to permit longitudinal movement thereof relative to first elongate medical device.

72. The method of claim 71, wherein the elongate engagement member comprises a stylet having a proximal hub, the stylet sized and configured to frictionally engage the wire guide about the coupling region in the fully advanced position when the stylet proximal hub engages the proximal handle.

46. 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 proximal portion, 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, 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 the wall of the tubular member;

b. repositioning at least one of the wire guide and first tubular member relative to the other until the operator has determined, by monitoring a system of indicia located about at least one of the wire guide and 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 third elongate medical device to the wire guide; and

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

47. 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 the work site;

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 first side 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 at least one of 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;

d. repositioning the wire guide and first elongate medical device relative to one another until it can be determined that the wire guide had 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 second or third elongate medical devices; and

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

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

a. advancing an endoscope into the duodenum of the patient, the endoscope having a pathway for receiving a wire guide having a distal end, distal portion and proximal portion, and first elongate medical device having a distal end, a distal portion, and a proximal portion;

b. advancing the wire guide and a first elongate medical device from the pathway of the endoscope into the common bile duct until the distal ends of the wire guide and the first elongate medical device are both are positioned within the biliary system, the wire guide and the first elongate medical device being coupled to one another via a coupling region located about the distal portion of the first elongate medical device such that the proximal portion of the wire guide extends proximally from coupling region located on the first elongate medical device;

c. monitoring the relative positions of the wire guide and the first elongate medical within the work site using an external imaging system;

d. performing a first medical operation within the biliary system using the first elongate medical device;

e. repositioning the wire guide and first elongate medical device relative to one another until the operator has established visual confirmation that the wire guide has disengaged from the coupling region such that the wire guide and the first elongate medical device are uncoupled while remaining within the biliary system;

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

g. advancing the third elongate medical device into the biliary system.

49. The method of claim 48, wherein the third elongate medical device comprises a tubular member having a passageway, wherein the wire guide is inserted into at least a portion of the passageway and the tubular member is advanced thereover.

50. The method of claim 48, wherein the third elongate medical comprises a second wire guide, the method further comprising the step of inserting the proximal end thereof into a passageway located within the first elongate medical device.

51. The method of claim 48, wherein the first medical operation include the step of infusing contrast media within the biliary system.

52. The method of claim 48, wherein the first medical operation includes the step of surgically enlarging the opening about the Papilla of Vater.

53. The method of claim 48, wherein the first elongate medical device comprises a tubular member and the coupling region comprises a passageway extending through the distal portion of the tubular member between a first opening located about the distal end thereof and a side access port located about the distal portion thereof.

54. The method of claim 48, wherein the first elongate medical device includes a passageway extending at least substantially therethrough, the passageway communicating proximally with a proximal side access port located proximal to the endoscope when the first elongate medical is residing within the biliary system, the method further comprising the steps of inserting the second wire guide into the proximal side access port and advancing the wire guide through the passageway into the biliary system.

55. The method of claim 54 wherein the first elongate medical device includes a deflectable distal portion, the method further comprising the steps of advancing the distal end of first wire guide into a first branch of a bodily passage within the biliary system;

disengaging the first wire guide from the coupling region of the first elongate medical device;

reorienting the distal end of the first elongate medical device to facilitate introduction of the distal end of the second wire guide into a second branch adjacent the first branch; and

advancing the distal end of the wire guide into the second branch.

56. The method of claim 54, further comprising the steps of withdrawing the first elongate medical device over the second wire guide;

advancing a fourth elongate medical device over the first wire guide into the first branch; and

advancing a fifth elongate medical device into the second branch.

57. The method of claim 56, wherein the fourth elongate medical device comprises a first prosthesis and the fifth elongate medical device comprises a second prosthesis, each of the first and second prostheses configured to permit the passage of fluids therethrough, the method further comprising the steps of deploying the first prosthesis within the first branch and deploying the second prosthesis within the second branch.

58. The method of claim 48, further comprising the step of lengthening the wire guide by attaching a proximal extension thereto.

59. The method of claim 56, wherein at least one of the first wire guide and the second wire guide comprises an exchange wire guide of sufficient length to accommodate at least one of the first, fourth, or fifth elongate medical devices about the proximal portion of the exchange wire guide such that an exchange procedure can be performed while control over the exchange wire guide is maintained.

60. The method of claim 48, wherein the first elongate medical device comprises a tubular member having a passageway extending at least partially therethrough, the distal portion thereof further comprising the coupling region;

and wherein the first end of the coupling region comprises a distal opening and the second end thereof comprises a side access port, the method further comprising the step of inserting the proximal end of the wire guide through the distal opening and passageway such that it exits the passageway via the side access port; and

advancing the tubular member over the wire guide.

61. The method of claim 48, wherein visual confirmation of uncoupling is established using imageable indicia located on the wire guide and the first elongate medical device, the method further including the step of monitoring the relative positioning of the imageable indicia to determine that the wire guide has become uncoupled from the coupling region of the first elongate medical device.

62. The method of claim 61 wherein the imageable indicia include a first indicator located about the distal end of the wire guide and a second indicator located about the second end of the coupling region.

63. The method of claim 62, wherein the first and second indicators comprise a radiopaque material.

64. The method of claim 48, wherein visual confirmation of uncoupling is established at least in part using the relative alignment of indicia located about the proximal portion of at least one of the wire guide and the first elongate medical device with an alignment reference point.

65. The method of claim 64, wherein the alignment reference point is located on the other of the wire guide and the first elongate medical device.

66. The method of claim 64, wherein the alignment reference point is disposed on the endoscope or instrumentation attached thereto.

67. The method of claim 48, wherein the distal portion of the first elongate medical device includes a working portion configured to perform an intended medical operation, and wherein visual confirmation of uncoupling is established at least in part using the relative alignment of indicia located about the distal portions of the wire guide and the first elongate medical device, the indicia configured such that they are viewable via the endoscope when the working portion and the distal end of the wire guide are residing in within the biliary system.

68. The method of claim 48, wherein the third elongate medical device is introduced into the biliary system to perform a second medical operation comprising at least one of extracting an object, dilating a passageway or stricture, removing a tissue sample, placing a prosthesis, infusing an agent, and introducing a therapeutic material.

69. The method of claim 48, wherein the agent includes a contrast agent viewable under radiographic imaging.

73. The method of claim 48, wherein the alignment indicator system include a first indicator located about an intermediate portion of the wire guide and the first elongate medical device, respectively, the first and second indicators being generally viewable by an endoscope when the wire guide and first elongate medical device are positioned within the work site.