Drainage catheter delivery system

• US 6,248,100 B1
• Filed: 05/14/1999
• Issued: 06/19/2001
• Est. Priority Date: 08/14/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: de Toledo, Fernando Alvarez, Ciannella, Michael, Ostrowski, Susan M., Solbjor, Albert N.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/312,341
• Time in Patent Office: 767 Days
• Field of Search: 604/540, 604/264, 604/523, 604/541, 604/543, 604/544, 604/528, 604/500, 604/514, 604/517, 604/515, 604/93.01, 604/103.04, 604/164.13, 604/8, 606/191, 623/1.11, 600/585
• US Class Current: 604/540
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A single operator drainage catheter delivery system and method of use. The delivery system includes a guide member having a guidewire lumen extending through a distal portion thereof, with a proximal guidewire port located distal of the proximal end. A placement catheter disposed over the guide member has a catheter lumen extending through a distal portion thereof, with a proximal guidewire port located distal of the proximal end. Locating the proximal guidewire ports as such allows the delivery system to be used by a single person with a shorter guidewire. A drainage catheter is disposed about the guide member distal of the placement catheter. The drainage catheter delivery system preferably includes a means for releasably connecting the placement catheter to the drainage catheter, wherein the releasable connecting means disconnects the drainage catheter upon displacement of the guide member.

Claims

1. A drainage catheter delivery system for use with a guidewire, comprising:

a guide member having a proximal end, a distal end and a guidewire lumen extending therethrough, the guidewire lumen extending from a proximal port located distal of the proximal end of the guide member to a distal port located adjacent the distal end of the guide member;

a placement catheter having a proximal end, a distal end, and a catheter lumen extending therethrough, the catheter lumen extending from a proximal port located distal of the proximal end of the placement catheter to a distal port located adjacent the distal end of the placement catheter, the placement catheter disposed over the guide member and longitudinally movable relative thereto; and

a drainage catheter disposed about the guide member distal of the placement catheter.

2. A drainage catheter delivery system as in claim 1, wherein the guide member includes a proximal portion and a distal portion, the proximal portion of the guide member including a stop mechanism which limits proximal displacement of the guide member relative to the placement catheter.

3. A drainage catheter delivery system as in claim 2, wherein the distal portion of the guide member comprises a tube.

4. A drainage catheter delivery system as in claim 3, wherein the drainage catheter is disposed about the distal tubular portion of the guide member.

5. A drainage catheter delivery system as in claim 4, wherein the proximal portion of the guide member has a lower profile than the distal portion of the guide member.

6. A drainage catheter delivery system as in claim 5, wherein the proximal portion of the guide member comprises a wire.

7. A drainage catheter delivery system as in claim 6, wherein the placement catheter includes a proximal portion and a distal portion, and wherein the distal portion of the placement catheter comprises a tube.

8. A drainage catheter delivery system as in claim 7, wherein the distal portion of the guide member is disposed in the distal tube portion of the placement catheter.

9. A drainage catheter delivery system as in claim 8, wherein the proximal portion of the placement catheter has a lower profile than the distal portion of the placement catheter.

10. A drainage catheter delivery system as in claim 9, wherein the proximal portion of the placement catheter comprises a tube.

11. A drainage catheter delivery system as in claim 10, wherein the proximal portion of the guide member is disposed in the proximal tube portion of the placement catheter.

12. A drainage catheter delivery system as in claim 11, wherein the distal portion of the placement catheter is longer than the distal portion of the guide member.

13. A drainage catheter delivery system as in claim 12, wherein the proximal portion of the placement catheter is shorter than the proximal portion of the guide member.

14. A drainage catheter delivery system as in claim 1, further comprising a means for releasably connecting a distal portion of the placement catheter to a proximal portion of the drainage catheter.

15. A delivery system as in claim 14, wherein the releasable connecting means disconnects the drainage catheter upon displacement of the guide member.

16. A delivery system as in claim 15, wherein the displacement is longitudinal.

17. A delivery system as in claim 16, wherein the displacement is in a proximal direction.

18. A delivery system as in claim 14, wherein the releasable connecting means comprises a tying mechanism.

19. A delivery system as in claim 18, wherein the tying mechanism comprises a flexible thread.

20. A delivery system as in claim 19, wherein the drainage catheter includes a passage, and wherein the flexible thread passes through the passage in the drainage catheter.

21. A delivery system as in claim 20, wherein the placement catheter includes a passage, and wherein the flexible thread passes through the passage in the placement catheter.

22. A delivery system as in claim 21, wherein the flexible thread forms a loop around the distal portion of the guide member disposed in the drainage catheter.

23. A delivery system as in claim 22, wherein the loop passes through the passage in the drainage catheter.

24. A drainage catheter delivery system for use with a guidewire, comprising:

a guide member having a proximal end, a distal end and a guidewire lumen extending therethrough, the guidewire lumen extending from a proximal port located distal of the proximal end of the guide member to a distal plot located adjacent the distal end of the guide member;

a placement catheter disposed over the guide member and longitudinally movable relative thereto, the placement catheter has a proximal end, a distal end, and a catheter lumen extending therethrough, the catheter lumen extending from a proximal port located distal of the proximal end of the placement catheter to a distal port located adjacent the distal end of the placement catheter;

a drainage catheter disposed about the guide member distal of the placement catheter; and

a means for releasably connecting the distal end of the placement catheter to a proximal end of the drainage catheter.

25. A method of delivering a drainage catheter to a target site in a duct of a patient, comprising the steps of:

providing a guidewire;

inserting the guidewire into the duct;

providing a drainage catheter delivery system comprising a guide member having a proximal end, a distal end and a guidewire lumen extending therethrough, the guidewire lumen extending from a proximal port located distal of the proximal end of the guide member to a distal port located adjacent the distal end of the guide member;

a placement catheter disposed over the guide member and longitudinally movable relative thereto, the placement catheter has a proximal end, a distal end, and a catheter lumen extending therethrough, the catheter lumen extending from a proximal port located distal of the proximal end of the placement catheter to a distal port located adjacent the distal end of the placement catheter;

a drainage catheter disposed about the guide member distal of the placement catheter; and

a means for releasably connecting the distal end of the placement catheter to a proximal end of the drainage catheter;

partially advancing the delivery system over the guidewire until the guidewire exits the proximal port of the guide member and the proximal port of the placement catheter;

holding the exit portion of the guidewire; and

further advancing the delivery system over the guidewire until the drainage catheter is adjacent the target site in the duct.

26. A method of delivering a drainage catheter to a target site in a duct of a patient, comprising the steps of:

providing a guidewire and a drainage catheter delivery system, wherein the delivery system includes a proximal guidewire exit port positioned distal of a proximal end and proximal of a distal end of the delivery system;

inserting the guidewire into the duct;

partially advancing the delivery system over the guidewire until the guidewire exits the proximal guidewire port of the delivery system;

holding the exit portion of the guidewire; and

further advancing the delivery system over the guidewire until the drainage catheter is adjacent the target site in the duct.

27. A drainage catheter delivery system comprising:

a placement catheter defining a placement catheter lumen, and including an abutment surface;

a drainage catheter defining a drainage catheter lumen and including a proximal end and a distal end, the proximal end of the drainage catheter selectively positioned to approximately abut the abutment surface of the placement catheter;

a guide member including a proximal end and a distal end configured to receive a guidewire and sized to be coaxially received within the drainage catheter lumen; and

a retention device for selectively connecting the drainage catheter to the placement catheter.

28. A delivery system as in claim 27, wherein the guide member includes a guide member body having a length such that in a loading position, the proximal end of the guide member is proximal a proximal end of the placement catheter, and the distal end of the guide member body is distal the abutment surface of the placement catheter.

29. A delivery system as in claim 28, wherein the abutment surface is located at a distal end of the placement catheter such that the drainage catheter is coaxially received over the distal end of the guide member in the loading position.

30. A delivery system as in claim 28, wherein the placement catheter includes a proximal portion, an intermediate portion and a distal portion having an outer diameter sized to be coaxially received within the drainage catheter lumen.

31. A delivery system as in claim 30, wherein the abutment surface is formed between the intermediate portion and the distal portion.

32. A delivery system as in claim 27, wherein the retention device includes a flexible thread secured to the placement catheter proximal the abutment surface.

33. A delivery system as in claim 32, wherein the flexible thread is sized to extend distal the abutment surface of the placement catheter.

34. A delivery system as in claim 33, wherein the drainage catheter includes a passage for selectively receiving a portion of the flexible thread.

35. A delivery system as in claim 34, wherein the flexible thread extends through the passage in the drainage catheter and selectively engages the distal end of guide member in the loading position.

36. A delivery system as in claim 35, wherein the placement catheter includes a distal portion extending from the abutment surface, the distal portion of the placement catheter having an outer diameter sized to coaxially receive the drainage catheter and including an opening, for facilitating engagement of the flexible thread with the guide member.

37. A delivery system as in claim 36, wherein the opening is positioned to be approximately radially aligned with the passage in the drainage catheter in the loading position.

38. A delivery system as in claim 27, wherein the guide member is configured to slide within the placement catheter from a loading position to a transfer position.

39. A delivery system as in claim 38, wherein the proximal end of the guide member includes a marking for identifying the transfer position.

40. A delivery system as in claim 38, wherein the retention device is configured to engage the guide member in the loading position and the guidewire in the transfer position.

41. A delivery system as in claim 27, wherein the placement catheter is configured to provide for rapid exchange relative to the guidewire.

42. A delivery system as in claim 41, wherein the rapid exchange feature is a channel formed in a sidewall of the placement catheter.

43. A delivery system as in claim 42, wherein the delivery system further comprises a sheath sized to selectively retain the guidewire within the channel.

44. A delivery system as in claim 27, wherein the distal end of the guide member forms a pocket sized to receive a proximal end of the guidewire.

45. A method of assembling a drainage catheter delivery system, the method including:

providing a placement catheter having a placement catheter lumen and an abutment surface;

providing a guide member having an outer diameter less than the placement catheter lumen, a proximal end and a distal end;

providing a drainage catheter having a drainage catheter lumen diameter greater than the outer diameter of the guide member;

sliding the guide member within the placement catheter lumen such that the distal end of the guide member extends distally from the abutment surface of the placement catheter;

aligning the drainage catheter over the distal end of the guide member such that a proximal end of the drainage catheter approximately abuts the abutment surface of the placement catheter; and

selectively securing the placement catheter to the drainage catheter with a retention device.

46. A method as in claim 45, wherein the retention device is a flexible thread secured to the placement catheter proximal the abutment surface, and further wherein selectively securing the placement catheter to the drainage catheter includes:

extending the flexible thread distal the abutment surface; and

forming a loop in the flexible thread about a portion of the guide member.

47. A method as in claim 46, wherein the drainage catheter includes a passage from an outer circumference to the drainage catheter lumen, and wherein forming a loop around the guide member includes:

directing a loop end of the flexible thread through the passage in the drainage catheter to the drainage catheter lumen; and

maneuvering the guide member to engage the loop end of the flexible thread.

48. A method as in claim 47, wherein the placement catheter further includes a distal portion extending distally from the abutment surface, the distal portion of the placement catheter having an outer diameter sized to coaxially receive the drainage catheter and further including an opening sized to allow passage of the flexible thread to the placement catheter lumen, and wherein selectively securing the placement catheter to the drainage catheter further includes:

directing the loop end of the flexible thread through the opening in the distal portion of the placement catheter before maneuvering the guide member.

49. A method as in claim 47, wherein securing the placement catheter to the drainage catheter further includes:

transferring the loop end of the flexible thread from the guide member to a guidewire.

50. A method as in claim 49, wherein transferring the loop end includes:

directing a distal end of the drainage catheter over the guidewire; and

advancing the placement catheter such that a distal end of the guide member receives a proximal end of the guidewire.

51. A method as in claim 45, wherein the placement catheter includes a channel sized to allow passage of a guidewire from the placement catheter lumen, the method further including positioning a sheath including a sheath body over the placement catheter for maintaining the guidewire within the placement catheter lumen.

52. A method of delivering a drainage catheter to a body cavity, the method including:

preassembling a drainage catheter delivery system including a placement catheter slidably maintaining a guide member and a drainage catheter, the placement catheter defining a placement catheter lumen and including an abutment surface, the guide member coaxially disposed within the placement catheter lumen and including a distal end extending distally from the abutment surface in a loading position, the drainage catheter being selectively secured to the placement catheter in approximate abutment with the abutment surface by a retention device;

positioning the delivery system within the body cavity such that the drainage catheter is proximate a desired location of the body cavity; and

releasing the drainage catheter from the placement catheter.

53. A method as in claim 52, wherein the distal end of the guide member is configured to selectively receive a guidewire, the method further including:

positioning the delivery system over a previously-positioned guidewire, such that the guidewire engages the distal end of the guide member; and

advancing the delivery system over the guidewire such that the guidewire forces the guide member to slide proximally within the placement catheter from the loading position to a transfer position in which the distal end of the guide member is proximal a leading end of the retention device.

54. A method as in claim 53, wherein the proximal end of the guide member includes a marking, and wherein advancing the delivery system over the guidewire includes advancing the delivery system over the guidewire until the marking on the guide member is visible from a proximal portion of the placement catheter.

55. A method as in claim 54, further including removing the guide member from the proximal portion of the placement catheter after the marking is visible.

56. A method as in claim 55, further including advancing the placement catheter over the guidewire after removing the guide member.

57. A method as in claim 55, wherein releasing the drainage catheter from the placement catheter includes retracting the guidewire from the placement catheter such that a distal end of the guidewire is proximal the abutment surface of the placement catheter.

58. A method as in claim 57, wherein the placement catheter includes a chattel extending from an outer wall to the placement catheter lumen, the channel positioned proximal the abutment surface, and wherein retracting the guidewire from the placement catheter includes directing a proximal end of the guidewire radially outwardly from the placement catheter through the channel.