Single operator exchange biliary catheter

• US 6,007,522 A
• Filed: 09/09/1997
• Issued: 12/28/1999
• Est. Priority Date: 09/13/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Nelson, Gordon, Brillo, Daniel, McAlister, Gary, Warich, Charles, Agro, Mark, Paille, Ronald
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Finkel, Sharon
• Application Number:
  US08/926,200
• Time in Patent Office: 840 Days
• Field of Search: 604/93, 604/19, 604/28, 604/49, 604/54, 604/158, 604/164-166, 604/171, 604/96, 604/280-283, 604/160, 604/528, 604/533, 606/46, 600/433-435, 600/585
• US Class Current: 604/264
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place

Abstract

Catheter for use in biliary procedures, including a shaft having a proximal end and a distal end. A guide wire lumen is carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft. A channel extending longitudinally between a first end and a second end is included for accessing the guide wire lumen from a location exterior the catheter shaft located distal the proximal end of the shaft. The catheter may be used in rapid exchange catheter procedures. The channel may be U-shaped, containing the guide wire yet allowing radial removal of the guide wire from the channel. The catheter may also be part of a device including an endoscope exchange sheath for constraining guide wire movement to the catheter channel while inside a large endoscope working channel.

Claims

1. In a catheter for use in biliary procedures including a shaft having a proximal end and a distal end, the improvement comprising:

a guide wire lumen carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft;

a channel for accessing the guide wire lumen from a location exterior to the catheter shaft, wherein the channel extends longitudinally along the shaft between a first end and a second end, the first end being located proximal the distal end of the shaft and the second end of the channel being located proximal of the first end of the channel, said channel extending over a substantial portion of the length of said catheter shaft.

2. The catheter of claim 1 wherein the guide wire lumen is formed integral with the shaft.

3. The catheter of claim 1, further including an ancillary lumen extending between the catheter proximal end and the catheter distal end.

4. The catheter of claim 1, wherein the channel for accessing the guide wire lumen includes an opening extending through the wall of the catheter shaft into the guide wire lumen.

5. The catheter of claim 4, wherein the opening extends longitudinally between the first end and the second end in communication with the guide wire lumen.

6. The catheter of claim 5, wherein the first end of the channel is in communication with the guide wire lumen.

7. The catheter of claim 1, wherein the guide wire lumen is sized to receive a guide wire having a diameter;

at least a portion of the channel having a width greater than the diameter of the guide wire to allow radial guide wire movement within the channel.

8. The catheter of claim 7, wherein the channel is formed integral with the guide wire lumen, such that the channel has a width approximately equal to a diameter of the guide wire lumen.

9. The catheter of claim 1 wherein the enlarged opening is located proximate the first end of the channel.

10. The catheter of claim 1 wherein the enlarged opening is located proximate the second end of the channel.

11. The catheter of claim 10 further comprising another enlarged opening located proximate the first end of the channel.

12. A biliary rapid exchange catheter system, comprising:

a biliary catheter sized for passage within the working passageway of an endoscope, the biliary catheter including;

a shaft having a proximal end, a distal end, and an outer wall;

the shaft having a guide wire lumen extending longitudinally therethrough, between a location proximate the distal end of the shaft and a location proximal of the distal end of the shaft, the guide wire lumen adapted for receiving a guide wire;

at least part of the outer wall of the shaft defining a channel, with the channel in communication with the guide wire lumen, an outer diameter of at least a portion of the shaft and the inner diameter of at least a portion of the working passageway of the endoscope being such that the guide wire is substantially maintained in the channel when so arranged.

13. The biliary catheter system of claim 12, wherein the guide wire lumen extends between the proximal end and the distal end of the shaft.

14. The biliary catheter system of claim 12, wherein the channel includes:

a distal opening into the guide wire lumen at a location proximal of the distal end of the shaft;

a proximal opening into the guide wire lumen at a location proximal of the distal opening; and

means extending longitudinally between the proximal opening and the distal opening for allowing a guide wire to be moved between a location exterior of the guide wire lumen and the guide wire lumen.

15. The biliary catheter system of claim 14, wherein the means for allowing the guide wire to be moved between a location exterior the guide wire lumen and the guide wire lumen includes an open channel extending longitudinally between the proximal opening and the distal opening.

16. The biliary catheter system of claim 15, wherein the guide wire lumen is sized to receive a guide wire having a diameter, and further wherein at least a portion of the open channel has a width greater than the diameter of the guide wire for allowing radial guide wire movement from the open channel.

17. The biliary catheter system of claim 15, wherein the distal opening of the open channel is in communication with a portion of the guide wire lumen.

18. The biliary catheter system of claim 15, wherein the open channel is integrally formed with the guide wire lumen.

19. The biliary catheter system of claim 15, wherein the open channel divides the guide wire lumen into a first and second section such that the first section of the guide wire lumen includes the open channel and the second section extends distally of the open channel.

20. The biliary catheter system of claim 15, wherein the open channel has a U-shape over a majority of the length between the proximal and distal openings.

21. The biliary catheter system of claim 12, wherein the guide wire lumen is defined by a tubular member, and the tubular member is formed integral with the shaft.

22. The biliary catheter system of claim 12, wherein the guide wire lumen is defined by a tubular member, and the tubular member is coupled to the shaft.

23. A biliary catheter rapid exchange system comprising:

a biliary catheter sized for passage within an endoscope including a shaft having a proximal end and a distal end;

a tubular member having a proximal end, a distal end, and a guide wire lumen extending longitudinally therethrough, the tubular member extending between a location proximate the distal end of the shaft and a location proximal of the distal end of the shaft;

a distal opening in communication with the guide wire lumen, at a location proximal of the distal end of the shaft;

a proximal opening into the guide wire lumen at a location proximal of the distal port;

means extending longitudinally between the proximal opening and the distal opening for allowing a guide wire to be moved between a location exterior of the guide wire lumen and the guide wire lumen, wherein the means for allowing the guide wire to be moved includes an open channel extending longitudinally between the proximal opening and the distal opening; and

an endoscope sheath assembly having a proximal end and a distal end and an inner passageway that is adapted to receive the catheter, the sheath assembly including a sheath at the distal end and a hub at the proximal end, an inner dimension of the passageway of the sheath and an outer dimension of the shaft being such that the guide wire is substantially maintained in the channel when so arranged.

24. The device of claim 23, wherein the inner passageway of the sheath is defined by a sheath wall, the sheath wall having a means for allowing radial removal of a guide wire contained therein.

25. The device of claim 24, wherein the means for allowing radial removal of a guide wire includes a longitudinal slit in the sheath wall.

26. The device of claim 24, wherein the means for allowing radial removal of a guide wire includes a circumferentially overlapping sheath wall.

27. A biliary rapid exchange catheter system, comprising:

a sheath having a passageway extending therethrough, the passageway having an inner dimension;

a biliary catheter sized for passage within the passageway of the sheath, the biliary catheter including;

a shaft having a proximal end, a distal end, and an outer wall;

the shaft having a guide wire lumen extending longitudinally therethrough between a location proximate the distal end of the shaft and a location proximal of the distal end of the shaft, the guide wire lumen adapted for receiving a guide wire;

at least part of the outer wall of the shaft defining a channel, with the channel in communication with the guide wire lumen;

an outer dimension of the shaft and the inner dimension of the passageway of the sheath being such that the guide wire is substantially maintained in the channel when so arranged.

28. The biliary rapid exchange catheter system of claim 27 further comprising an endoscope having a working passageway extending therethrough, the working passageway of the endoscope adapted to receive the sheath.

29. A method of positioning a biliary catheter within a patient'"'"'s alimentary comprising:

providing an endoscope having a working passageway extending therethrough, the working passageway having an inner dimension;

providing a catheter having a shaft with a proximal end and a distal end, and a guide wire lumen extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft, the shaft having a channel accessible through a sidewall thereof extending into the guide wire lumen, the channel located distal of the proximal end of the shaft, an outer dimension of at least a portion of the shaft and the inner dimension of at least a portion of the working passageway of the endoscope being such that the guide wire is substantially maintained in the channel when so arranged;

positioning the endoscope in the patient'"'"'s alimentary;

positioning the catheter in the working passageway of the endoscope; and

positioning the guide wire in the guide wire lumen and the channel of the shaft.

30. The method of claim 29, further including advancing the catheter over the guide wire.

31. The method of claim 29, further including advancing the catheter and the guide wire together into the working passageway of the endoscope.

32. The method of claim 29, further including withdrawing the catheter from the working passageway of the endoscope over the guide wire.

33. The method of claim 32, further including removing the guide wire from the channel of the shaft as the catheter exits the working passageway of the endoscope.

34. A method of exchanging a catheter during a biliary endoscopic procedure comprising the steps of:

passing an endoscope having a lumen extending longitudinally therethrough, through a patient'"'"'s mouth into the alimentary canal;

positioning a distal end of the endoscope proximate the opening into the biliary tree;

providing a catheter having a shaft and a guide wire lumen extending from a location proximal a distal end of the shaft to a location proximate the distal end of the shaft, and further including a channel into the guide wire lumen located distal of the proximal end of the shaft, an outer dimension of at least a portion of the shaft and an inner dimension of at least a portion of the lumen of the endoscope being such that a guide wire is substantially maintained in the channel when so arranged;

providing a guide wire through at least part of the channel; and

positioning the catheter and the guide wire in the lumen of the endoscope, with the guide wire positioned in the channel.

35. The method of claim 34, further including the step of retracting the catheter over the guide wire.

36. A system for performing biliary procedures comprising:

a catheter having a shaft with a proximal end and a distal end and a guide wire lumen extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft, the guide wire lumen having a diameter;

means for accessing the guide wire lumen from a location exterior to the catheter shaft, located distal the proximal end of the shaft, wherein the means for accessing the guide wire lumen includes,

a first enlarged opening through the wall of the catheter shaft into the guide wire lumen located proximal the distal end of the shaft,

a second enlarged opening through the wall of the shaft located proximal the first opening, and

a channel extending longitudinally between the first enlarged opening and the second enlarged opening, wherein the channel has a width allowing for radial guide wire removal; and

an endoscope sheath assembly having a proximal end and a distal end and an inner passageway that is adapted to receive the catheter, the sheath assembly including a sheath at the distal end and a hub at the proximal end, an inner dimension of the passageway of the sheath and an outer dimension of the shaft being such that the guide wire is substantially maintained in the channel when so arranged.

37. The system of claim 36, wherein the sheath includes a lumen therethrough defining a sheath wall, the sheath wall having a means for allowing radial removal of a guide wire contained therein.

38. The system of claim 37, wherein the means for allowing radial removal of a guide wire includes a longitudinal slit in the sheath wall.

39. The system of claim 37, wherein the means for allowing radial removal of a guide wire includes a circumferentially overlapping sheath wall.

40. A method of positioning a biliary catheter within a patient'"'"'s alimentary comprising:

providing a sheath having a passageway extending therethrough, the passageway having an inner dimension;

providing a catheter having a shaft with a proximal end and a distal end, and a guide wire lumen extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft, the shaft having a channel through a sidewall thereof extending into the guide wire lumen, the channel located distal of the proximal end of the shaft, an outer dimension of the shaft and the inner dimension of the passageway of the sheath being such that the guide wire is substantially maintained in the channel when so arranged;

positioning the sheath in the patient'"'"'s alimentary;

positioning the catheter in the passageway of the sheath, and positioning the guide wire in both the guide wire lumen and the channel of the shaft.

41. The method of claim 40 further comprising:

providing an endoscope with a working passageway extending therethrough;

positioning the endoscope in the patient'"'"'s alimentary; and

positioning the sheath in the working passageway of the endoscope.