Methods and devices to clear obstructions from medical tubes

• US 7,951,243 B2
• Filed: 01/26/2009
• Issued: 05/31/2011
• Est. Priority Date: 01/25/2008
• Status: Active Grant

• Current Assignee: ClearFlow, Inc.
• Original Assignee: Clear Catheter Systems, Inc., Cleveland Clinic Foundation
• Inventors: Boyle, Edward M. Jr., Leonard, Paul C., Kiderman, Sam, Gillinov, Alan Marc, Cohn, William E., Dale, Nathan J.
• Primary Examiner(s): Kornakov; Michael
• Assistant Examiner(s): CAMPBELL, NATASHA N.
• Application Number:
  US12/359,826
• Publication Number:
  US 20090188531A1
• Time in Patent Office: 855 Days
• Field of Search: 134/8, 134/22.11, 134/166.C, 151/040.5, 604/540, 604/541, 604/544, 604/318, 606/159, 606/127, 606/106
• US Class Current: 134/8
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2090/701 for flexible tubular instruments, e.g. endoscopes
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61M 1/83 Tube strippers, i.e. for clearing the contents of the tubes
• CPC Class Codes: A61M 1/87 Details of the aspiration tip, not otherwise provided for
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: B08B 9/0436 provided with mechanical cleaning tools, e.g. scrapers, with or without additional fluid jets B08B9/045, B08B9/047 take precedence

Abstract

A device for clearing obstructions from a medical tube, such as a chest tube, is disclosed in various embodiments. The device features a shuttle member that is magnetically coupled to a guide wire within a guide tube, through the guide-tube wall, so that translation of the shuttle member induces a corresponding translation of the guide wire within the guide tube, without penetrating or compromising the guide-tube wall. In this manner, when the guide tube is coupled to a medical tube where obstructions have formed, the guide wire and clearance member may be inserted into and withdrawn from the medical tube, via actuation of the shuttle member, to engage and help clear such obstructions from the medical tube without compromising the sterile field. Methods of clearing a medical tube of obstructions are also disclosed.

Claims

1. A device for clearing obstructions from a medical tube, the device comprising a shuttle guide tube having an inner diameter, a shuttle member disposed outside the guide tube and adapted to translate along a length thereof, an elongate guide member, a clearance member attached to or formed integrally with said guide member, and a magnetic guide secured to said guide member, said magnetic guide being adapted to be magnetically coupled to said shuttle member through a wall of said guide tube so that translation of said shuttle member along the length thereof induces a corresponding translation of said guide member.

2. The device of claim 1, said shuttle member comprising a through bore, said guide tube being slidably received through the through bore of said shuttle member to accommodate translation of the shuttle member over said guide tube and along its length.

3. The device of claim 1, said magnetic guide comprising one or a plurality of first magnetic elements, said shuttle member comprising one or a plurality of second magnetic elements, said first and second magnetic elements being magnetically attracted to one another to thereby magnetically couple said magnetic guide to said shuttle member.

4. The device of claim 3, all said first and second magnetic elements being selected from the group consisting of metal elements having magnetic properties and permanent magnets, wherein at least one of said first and second magnetic elements is a permanent magnet.

5. The device of claim 3, said one or a plurality of second magnetic elements each being in the form of a ring, wherein said guide tube passes through an opening through each said ring.

6. The device of claim 4, said permanent magnet having axially-aligned North-South polarity relative to a longitudinal axis of the guide tube.

7. The device of claim 1, further comprising a first fitting coupled to the guide tube'"'"'s proximal end, and a second fitting coupled to the guide tube'"'"'s distal end, each said first and second fitting defining or tapering to a smaller inner diameter than the inner diameter of said guide tube, first and second retaining members secured at proximal and distal ends, respectively, of said magnetic guide, each said first and second retaining member being dimensioned so it cannot pass through the reduced inner diameter of the respective first or second fitting.

8. The device of claim 7, said first and second retaining members each comprising a wire loop having a diameter substantially corresponding to the inner diameter of said guide tube.

9. The device of claim 1, further comprising a medical tube coupled to the guide tube'"'"'s distal end, said medical tube having a smaller inner diameter than said guide tube, a retaining member secured at a distal end of said magnetic guide, said retaining member being dimensioned so it cannot pass through the inner diameter of said medical tube.

10. The device of claim 9, said medical tube being coupled to said guide tube via a fitting.

11. The device of claim 9, said retaining member comprising a wire loop having a diameter substantially corresponding to the inner diameter of said guide tube.

12. The device of claim 1, further comprising a shuttle stop secured to an outer wall of the guide tube in a distal region thereof, said shuttle member and shuttle stop having respective first and second parking surfaces, wherein as the shuttle member is translated distally along the length of the guide tube, said shuttle member reaches a parking station where the respective first and second parking surfaces are in contact or adjacent one another.

13. The device of claim 12, said shuttle stop having a parking magnetic element disposed behind or forming said second parking surface thereof.

14. The device of claim 12, further comprising a medical tube having a proximal end, a distal end and a length therebetween, said guide member having a length between its distal end and said magnetic guide that is substantially equal to the length of said medical tube plus a distance between said shuttle stop and the proximal end of said medical tube when the proximal end of said medical tube is coupled to the distal end of said guide tube.

15. The device of claim 14, said medical tube being a chest tube.

16. The device of claim 1, said clearance member being disposed at a distal end of said guide member.

17. The device of claim 1, said guide member being a guide wire, said clearance member comprising a loop formed from or attached to a terminal portion of said guide wire.

18. The device of claim 17, said loop lying in a plane that is at an angle to a longitudinal axis of said guide wire at a point where said loop and guide wire intersect.

19. The device of claim 18, said angle being in the range of 75°

to 105°

.

20. The device of claim 17, further comprising a medical tube having an inner diameter and a proximal end adapted to be coupled to a distal end of said guide tube, said loop having a diameter that substantially corresponds to the inner diameter of said medical tube.

21. The device of claim 1, said guide member being flexible but biased to a straight configuration.

22. The device of claim 1, said guide member being a guide wire comprising a core wire and a sheath wire wound around the core wire to provide a spiral-wound wire sheath.

23. The device of claim 1, further comprising a medical tube coupled to the guide tube'"'"'s distal end, said medical tube having an inner surface that defines a slot extending longitudinally along a length of said medical tube that is adapted to accommodate said guide member therein.

24. The device of claim 1, further comprising a medical tube coupled to the guide tube'"'"'s distal end, said medical tube comprising one or a plurality of apertures through a wall of said medical tube in a distal region thereof, said clearance member being dimensioned and oriented so that it cannot pass through said one or a plurality of apertures.

25. The device of claim 1, said guide member having a proximal region and a distal region, said clearance member being attached to or formed integrally with said guide member in said distal region thereof, said magnetic guide being secured to said guide member in said proximal region thereof.

26. The device of claim 1, said guide member having a guide lumen extending along its length and being in fluid communication with one or more openings disposed through a wall of said clearance member, said guide lumen being adapted to deliver fluid so that said fluid is expelled through said openings.

27. The device of claim 1, further comprising a medical tube, and normally-closed valves provided at respective mating ends of said medical tube and guide tube, wherein said valves are operable to provide fluid communication between said medical and guide tubes when said tubes are connected, and are further operable to seal their respective mating ends, wherein a fluid opening through said valves when opened is large enough to accommodate said clearance member therethrough.

28. The device of claim 1, further comprising a medical tube coupled to the guide tube'"'"'s distal end, and a CO₂-sensor provided to detect the presence of CO₂ in said medical tube or in a guide lumen extending through said guide member.

29. The device of claim 1, further comprising a wire manipulation device effective to deliver energy or motion to the clearance member when in use.

37. The device of claim 1, further comprising a shuttle stop secured to the guide tube in a distal region thereof, said shuttle member being attachable to said shuttle stop via a reversible mechanical attachment mechanism.

49. The device of claim 1, said guide member comprising a guide wire having sufficient flexibility that said guide wire can reversibly bend to a radius of curvature of two centimeters without snapping or substantially compromising its structural integrity.

50. The device of claim 1, said guide member being coated with a friction-reducing material.

51. The device of claim 1, said guide member being coated with a therapeutic agent.

52. The device of claim 2, said magnetic guide comprising one or a plurality of first magnetic elements, said shuttle member comprising one or a plurality of second magnetic elements, said first and second magnetic elements being magnetically coupled, said shuttle member comprising a magnetic shield that at least partially encloses said coupled first and second magnetic elements.

53. The device of claim 17, said loop being a wire loop made from wire having a diameter about or less than 10% of an inner diameter of said medical tube.

54. The device of claim 17, further comprising a medical tube having a medical-tube passageway and a conical clearance-member seat extending radially inward and in a proximal direction from a distal end of said medical tube.

55. The device of claim 1, further comprising a medical tube having a proximal end and a distal end, said medical tube proximal end being coupled to said guide tube, a shuttle stop on said guide tube wherein said shuttle member is configured to normally engage said shuttle stop at a parking station for said shuttle member when not in use, said guide member having a length between its distal end and said magnetic guide such with said shuttle guide in said parking station said clearance member is disposed adjacent the medical tube distal end but does not emerge therefrom.

57. The device of claim 1, said shuttle member comprising one or a plurality of magnetic elements that emanate a magnetic field, and a magnetic shield effective to reduce extension of said magnetic field beyond said shuttle member.

30. A method of clearing obstructions from a medical tube, comprising coupling a shuttle guide tube with a medical tube;

and translating a shuttle member disposed outside the guide tube along a length thereof to correspondingly translate an elongate guide member that is at least partially disposed within said guide tube and magnetically coupled to said shuttle member through a wall of said guide tube, thereby correspondingly translating a clearance member attached to or formed with said guide member through said medical tube.

31. The method of claim 30, said medical tube and guide tube being coupled via a fitting.

32. The method of claim 30, a magnetic guide being secured to said guide member in a proximal region thereof, said magnetic guide comprising one or a plurality of first magnetic elements, said shuttle member having one or a plurality of second magnetic elements, said guide member and said shuttle member being magnetically coupled through cooperation of said first and second magnetic elements.

33. The method of claim 32, at least one of said first and second magnetic elements being a permanent magnet.

34. The method of claim 30, wherein the translation of said shuttle member, and the corresponding translation of said guide member and clearance member, do not compromise a sterile field defined between a body cavity where a distal end said medical tube has been inserted, said medical tube and said guide tube.

35. A method of clearing obstructions from a medical tube, comprising coupling a shuttle guide tube with a medical tube, thereby defining a sterile field within the respective tubes, and translating a shuttle member disposed outside the guide tube along a length thereof to correspondingly translate an elongate guide member that is at least partially disposed within said guide tube without compromising the sterile field, thereby correspondingly translating a clearance member attached to or formed with said guide member through said medical tube.

38. The method of claim 35, said clearance member comprising a loop.

39. The method of claim 35, said guide member comprising a guide wire, said clearance member comprising a wire loop formed from or attached to a terminal portion of said guide wire.

40. The method of claim 38, said loop lying in a plane that is at an angle to a longitudinal axis of said guide member at a point where said loop and said guide member intersect.

41. The method of claim 40, said angle being in the range of 75°

to 105°

.

42. The method of claim 38, said loop having a diameter that substantially corresponds to an inner diameter of said medical tube.

43. The method of claim 38, a proximal end of said medical tube being coupled to a distal end of said guide tube, said loop being disposed in said medical tube, said loop presenting a substantially unobstructed pathway therethrough for the flow of material from a location in said medical tube distal to said loop to a location in said medical tube proximal to said loop regardless whether said clearance member is being translated or is at rest within said medical tube.

44. The method of claim 38, said guide member being flexible but biased to a straight configuration.

45. The method of claim 38, said guide member being a guide wire comprising a core wire and a sheath wire wound around the core wire to provide a spiral-wound wire sheath.

46. The method of claim 38, said medical tube comprising one or a plurality of apertures through a wall of said medical tube in a distal region thereof, said clearance member being dimensioned and oriented so that it cannot pass through said one or a plurality of apertures.

47. The method of claim 38, said shuttle member being magnetically coupled, through a wall of said shuttle guide tube, to a magnetic guide secured to said guide member, such that translation of said shuttle member along the length of said guide tube magnetically induces a corresponding translation of said guide member through said guide tube.

48. The method of claim 35, said guide member being configured such that said clearance member cannot exit said medical tube upon advancement of said guide member through said medical tube from said shuttle guide tube.

56. The method of claim 35, said clearance member being normally disposed in said medical tube adjacent its distal end but not emerging therefrom, wherein to clear said medical tube of obstructions said shuttle member is initially withdrawn in a proximal direction along said guide tube, thereby initially withdrawing said clearance member from its resting position adjacent said medical tube distal end to engage and draw present debris proximally, away from said medical tube distal end.

36. A chest-tube assembly comprising a chest tube, a clearance device adapted to couple with and dislodge debris accumulated within said chest tube, and a CO₂ sensor provided in fluid communication with said chest tube to sense the presence of CO₂ in said chest tube.