System for introducing multiple medical devices

• US 20050070794A1
• Filed: 07/29/2004
• Published: 03/31/2005
• Est. Priority Date: 07/31/2003
• Status: Abandoned Application

• Current Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Kennedy, Kenneth C. II, Hardin, David M. Jr., Deal, Stephen E., Skerven, Gregory J., Rucker, Brian K., Waller, David F., Carter, Matthew P., Haller, Frederick B.
• Application Number:
  US10/901,561
• Publication Number:
  US 20050070794A1
• Time in Patent Office: Days
• US Class Current: 600/434
• 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, 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 first indicator disposed on the shaft, and 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; and

a wire guide having a distal end, a proximal end, and a second indicator,

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 first indicator is positioned relative to the second indicator to determine whether the wire guide has moved from the coupled position to the uncoupled position.

2. The system of claim 1, wherein the first indicator comprises a first distal system of indicia located near the proximal opening of the elongate medical device and the second indicator comprises a second distal system of indicia located near the distal end of the wire guide.

3. The system of claim 2, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first distal system of indicia substantially adjacent to the second distal system of indicia.

4. The system of claim 2, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first distal system of indicia distal to the second distal system of indicia.

5. The system of claim 2, wherein the first distal system of indicia and the second distal system of indicia each comprise a radiopaque marker.

6. The system of claim 5, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the radiopaque marker of the first distal system of indicia substantially adjacent to or distal of the radiopaque marker of the second distal system of indicia.

7. The system of claim 2, wherein the first distal system of indicia and the second distal system of indicia each comprise an ultrasonic reflective marker.

8. The system of claim 7, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the ultrasonic reflective marker of the first distal system of indicia substantially adjacent to or distal of the ultrasonic reflective marker of the second distal system of indicia.

9. The system of claim 1, wherein the first indicator comprises a first proximal system of indicia located a substantial distance from the distal end of the elongate medical device and the second indicator comprises a second proximal system of indicia located a substantial distance from the distal end of the wire guide.

10. The system of claim 9, wherein the first proximal system of indicia and the second proximal system of indicia are each disposed outside of the bodily lumen of the patient when the wire guide is moved from the coupled position to the uncoupled position.

11. The system of claim 9, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first proximal system of indicia substantially adjacent to the second proximal system of indicia.

12. The system of claim 9, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first proximal system of indicia distal to the second proximal system of indicia.

13. The system of claim 9, wherein the first proximal system of indicia and the second proximal system of indicia each comprise a directly viewable marker.

14. The system of claim 13, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the directly viewable marker of the first proximal system of indicia substantially adjacent to or distal of the directly viewable marker of the second proximal system of indicia.

15. The system of claim 9, wherein the first proximal system of indicia comprises a visual marker disposed along the shaft of the elongate medical device, the visual marker comprising a color that contrasts with a color of the shaft of the elongate medical device.

16. The system of claim 9, wherein the wire guide comprises a first portion having a first color and a second portion having a second color, the first color contrasting with the second color, further wherein the second proximal system of indicia is defined by a transition between the first portion and the second portion.

17. The system of claim 9, wherein the wire guide comprises a first portion having a first surface pattern and a second portion having a second surface pattern, the first surface pattern being distinguishable from the second surface pattern, further wherein the second proximal system of indicia is defined by a transition between the first surface pattern and the second surface pattern.

18. The system of claim 1, wherein the first indicator comprises a first intermediate system of indicia located a substantial distance from the proximal end of the elongate medical device and a relatively shorter distance from the distal end of the elongate medical device, and the second indicator comprises a second intermediate system of indicia located a substantial distance from the proximal end of the wire guide and a relatively shorter distance from the distal end of the wire guide.

19. The system of claim 18, wherein the first intermediate system of indicia and the second intermediate system of indicia are each directly viewable by a scope device when the wire guide is moved from the coupled position to the uncoupled position.

20. The system of claim 19, wherein the distal end of the elongate medical device and the distal end of the wire guide are not directly viewable by the scope device when the wire guide is moved from the coupled position to the uncoupled position.

21. The system of claim 20, wherein the scope device comprises a video or fiberoptic endoscope.

22. The system of claim 18, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first intermediate proximal system of indicia substantially adjacent to the second intermediate system of indicia.

23. The system of claim 18, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the first intermediate system of indicia distal to the second intermediate system of indicia.

24. The system of claim 18, wherein the first intermediate system of indicia and the second intermediate system of indicia each comprise a visual marker.

25. The system of claim 24, wherein the wire guide is moved from the coupled position to the uncoupled position by positioning the visual marker of the first intermediate system of indicia substantially adjacent to or distal of the visual marker of the second intermediate system of indicia.

26. The system of claim 1, wherein the first indicator comprises a first tactile system of indicia located near the proximal opening of the elongate medical device and the second indicator comprises a second tactile system of indicia located near the distal end of the wire guide.

27. The system of claim 26, wherein the wire guide is moved from the coupled position to the uncoupled position by engaging the first tactile system of indicia with the second tactile system of indicia.

28. The system of claim 27, wherein the first tactile system of indicia comprises a flexible skirt disposed about the proximal opening of the elongate medical device and the second tactile system of indicia comprises a raised portion that projects outwardly from a surface of the wire guide.

29. The system of claim 27, wherein the first tactile system of indicia comprises a first magnet disposed near the proximal opening of the elongate medical device and the second tactile system of indicia comprises a second magnet disposed near the distal end of the wire guide.

30. The system of claim 27, wherein the first tactile system of indicia comprises a first sensor and the second tactile system of indicia comprises a second sensor, the first sensor and the second sensor generating a signal indicating the relative position of the first sensor to the second sensor.

31. The system of claim 1, wherein the proximal opening comprises a side access port located a substantial distance from the proximal end of the elongate medical device and a relatively shorter distance from distal end of the elongate medical device, and further wherein the lumen extends proximally from the coupling region to a proximal access port located a substantial distance from the distal end of the elongate medical device and a relatively shorter distance from the proximal end of the elongate medical device.

32. The system of claim 31, wherein at least a portion of the shaft of the elongate member is configured to permit the wire guide to be moved out of the lumen by passing laterally through a wall portion of the shaft.

33. The system of claim 32, wherein the wall portion of the shaft comprises one of an open channel, a split, a score, a perforation, a reduced cross-section, and a relatively weak material for facilitating the lateral movement of the wire guide there through.

34. The system of claim 1, further comprising an introducer member having a distal end, a proximal end, and a working channel extending there between, wherein the distal end of the introducer member is positioned within the bodily lumen of the patient near the work site and the proximal end of the introducer member is positioned outside of the bodily lumen of the patient, wherein a portion of the elongate medical device and a portion of the wire guide extend through the working channel of the introducer member, and wherein the coupling region of the elongate medical device is disposed distally of the distal end of the introducer member when the wire guide is moved from the coupled position to the uncoupled position.

35. The system of claim 34, wherein the first indicator and the second indicator are each disposed distally of the distal end of the introducer member when the wire guide is moved from the coupled position to the uncoupled position.

36. The system of claim 34, wherein the first indicator and the second indicator are each disposed proximally of the working channel of the introducer member when the wire guide is moved from the coupled position to the uncoupled position.

37. The system of claim 34, wherein the work site is the patient'"'"'s biliary system, the introducer member comprises an endoscope, and the elongate medical device comprises a biliary catheter having an overall length sufficient to reach the patient'"'"'s biliary tree.

38. The system of claim 37, wherein the elongate medical device is one of an ERCP catheter, a sphincterotome, a needle knife, an extraction balloon, a dilation balloon, an extraction basket, a cytology brush, a dilator catheter, and a stent delivery catheter.

39. The system of claim 1, wherein the elongate medical device has a first overall length and the wire guide has a second overall length, the first overall length being greater than the second overall length.

40. The system of claim 31, wherein the elongate medical device further comprises a second side access port located a substantial distance from the distal end of the elongate medical device and a relatively shorter distance from proximal end of the elongate medical device, the second side access port being in communication with the lumen.

41. The system of claim 40, wherein at least a portion of the shaft of the elongate member extending between the side access port and the second side access port is configured to permit the wire guide to be moved out of the lumen by passing laterally through a wall portion of the shaft.

42. The system of claim 1, wherein the proximal opening comprises an elongated opening through a wall of the shaft.

43. The system of claim 1, wherein the wire guide comprises an elongate shaft extending between the distal end and the proximal end, the elongate shaft comprising a plurality of shaft sections having different properties.

44. The system of claim 43, wherein the plurality of shaft sections comprise different flexibilities.

45. The system of claim 43, wherein the plurality of shaft sections comprise different frictional surface coefficients.

46. The system of claim 1, wherein the wire guide comprises an elongate shaft extending between the distal end and the proximal end, the elongate shaft including an internal lumen extending along at least a portion thereof.

47. The system of claim 1, wherein the wire guide is uncoupled from the elongate medical device, and wherein the system further comprises a second elongate medical device having a distal end, a shaft, and a lumen extending through a portion of the shaft, the wire guide extending through the lumen of the second elongate medical device, and the distal end of the second elongate medical device is disposed within the bodily lumen of the patient and near the distal end of the elongate medical device.

48. The system of claim 1, wherein the wire guide is uncoupled from the elongate medical device, and wherein the system further comprises a second wire guide having distal end, the second wire guide being extending through the lumen of the elongate medical device, and the distal end of the second wire guide is disposed within the bodily lumen of the patient and near the distal end of the wire guide.

49. The system of claim 1, further comprising a third indicator disposed on one of the elongate member and the wire guide, wherein the third indicator is positioned relative to one of the first indicator and the second indicator to determine whether the distal end of the elongate member is aligned with the distal end of the wire guide when the wire guide is coupled with the elongate member.

50. The system of claim 49, wherein the third indicator is disposed on the wire guide and is spaced proximally of the second indicator by a distance equal to a length of the coupling region.

51. The system of claim 49, wherein the third indicator is disposed on the shaft of the elongate member and is spaced distally of the first indicator by a distance equal to a length of the coupling region.

61. The elongate medical device of claim 50, wherein the wall portion of the shaft comprises one of an open channel, a split, a score, a perforation, a reduced cross-section, and a relatively weak material for facilitating the lateral movement of the wire guide there through.

52. An elongate medical device for use with a wire guide having a distal end, the elongate medical device comprising a shaft extending between a distal end and a proximal end, an alignment system disposed on the shaft, and 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, the proximal opening being located a substantial distance from the proximal end, the coupling region being configured to receive a wire guide extending there through,

wherein the alignment system provides a user with a determination as to whether the wire guide extends through the lumen of the coupling region, the determination being provided while the distal end of the elongate medical device is disposed within a bodily lumen of a patient.

53. The elongate medical device of claim 52, wherein the wire guide is movable from a coupled position to an uncoupled position while maintaining the coupling region 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 alignment system provides a determination as to when the wire guide has moved from the coupled position to the uncoupled position.

54. The elongate medical device of claim 52, wherein the alignment system comprises a first indicator on the elongate medical device that is configured to align with a second indicator on the wire guide when the distal end of the wire guide is near the proximal opening of the coupling region.

55. The elongate medical device of claim 54, wherein the first indicator is a first radiopaque marker located near the proximal opening, and wherein the second indicator is a second radiopaque marker located near the distal end of the wire guide.

56. The elongate medical device of claim 54, wherein and the first indicator is a first visual marker located on a proximal portion of the shaft of the elongate member and the second indicator is a second visual marker located on a proximal portion of the wire guide such that the first and second visual markers remain outside of the bodily lumen of the patient while the distal ends of the elongate medical device and the wire guide are disposed within the bodily lumen of the patient.

57. The elongate medical device of claim 54, wherein and the first indicator is a first visual marker located on a distal portion of the shaft of the elongate member and the second indicator is a second visual marker located on a distal portion of the wire guide such that the first and second visual markers are within the visual range of a scope device while the distal ends of the elongate medical device and the wire guide are disposed within the bodily lumen of the patient, the distal ends of the elongate medical device and the wire guide being disposed distally of the visual range of the scope device.

58. The elongate medical device of claim 54, wherein the first indicator is a first tactile indicator located near the proximal opening, and wherein the second indicator is a second tactile indicator located near the distal end of the wire guide, the first and second tactile indicators being configured to provide the user with a tactile indication as to when the distal end of the wire guide is near the proximal opening of the coupling region.

59. The elongate medical device of claim 52, wherein the lumen extends proximally from the coupling region to a proximal access port located a substantial distance from the distal end of the elongate medical device and a relatively shorter distance from proximal end of the elongate medical device.

60. The elongate medical device of claim 59, wherein at least a portion of the shaft of the elongate member is configured to permit the wire guide to be moved out of the lumen by passing laterally through a wall portion of the shaft.

62. The elongate medical device of claim 54, wherein the alignment system comprises a third indicator that is configured to align with the second indicator on the wire guide when the distal end of the wire guide is near the distal end of the elongate medical device.

63. The elongate medical device of claim 62, wherein the third indicator is disposed on the shaft of the elongate member and is spaced distally of the first indicator by a distance equal to a length of the coupling region.

64. A wire guide for use with an elongate medical device having a coupling region, the coupling region having a length that is substantially shorter than that of the elongate medical device, the wire guide comprising elongated shaft extending between a proximal end and a distal end, and an alignment system disposed on the elongated shaft,

wherein the alignment system provides a user with a determination as to whether the wire guide extends through the coupling region of the elongate medical device, the determination being provided while the distal end of the wire guide is disposed within a bodily lumen of a patient.

65. The wire guide of claim 64, wherein the wire guide is movable from a coupled position to an uncoupled position while maintaining the distal end of the wire guide and the coupling region of the elongate medical device 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 alignment system provides a determination as to when the wire guide has moved from the coupled position to the uncoupled position.

66. The wire guide of claim 64, wherein the alignment system comprises a first indicator on the wire guide that is configured to align with a second indicator on the elongate medical device when the distal end of the wire guide is near a proximal end of the coupling region.

67. The wire guide of claim 66, wherein the first indicator is a first radiopaque marker located near the distal end of the wire guide, and wherein the second indicator is a second radiopaque marker located near a side access port of the elongate medical device, the side access port defining the proximal end of the coupling region.

68. The wire guide of claim 66, wherein and the first indicator is a first visual marker located on a proximal portion of the elongated shaft of the wire guide and the second indicator is a second visual marker located on a proximal portion of the elongated medical device such that the first and second visual markers remain outside of the bodily lumen of the patient while the distal end of the wire guide and the coupling region of the elongate medical device are disposed within the bodily lumen of the patient.

69. The wire guide of claim 66, wherein and the first indicator is a first visual marker located on a distal portion of the shaft of the wire guide and the second indicator is a second visual marker located on a distal portion of the elongate member such that the first and second visual markers are within the visual range of a scope device while the distal end of the wire guide and the coupling region are disposed within the bodily lumen of the patient, the distal end of the wire guide and the coupling region being disposed distally of the visual range of the scope device.

70. The wire guide of claim 66, wherein the first indicator is a first tactile indicator located near located near the distal end of the wire guide, and wherein the second indicator is a second tactile indicator located near the proximal end of the coupling region, the first and second tactile indicators being configured to provide the user with a tactile indication as to when the distal end of the wire guide is near the proximal end of the coupling region.

71. The wire guide of claim 66, wherein the alignment system comprises a third indicator that is configured to align with the second indicator on the elongate medical device when the distal end of the wire guide is near a distal end of the elongate medical device.

72. The wire guide of claim 71, wherein the third indicator is disposed on the shaft of the wire guide and is spaced proximally of the first indicator by a distance equal to a length of the coupling region of the elongate medical device.