Body-space drainage-tube debris removal

• US 20060264988A1
• Filed: 05/03/2004
• Published: 11/23/2006
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: ClearFlow, Inc.
• Original Assignee: Metolius Biomedical LLC
• Inventors: Boyle, Edward M.
• Granted Patent: US 7,854,728 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 2090/701 for flexible tubular instruments, e.g. endoscopes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61M 1/76 Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• 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 2027/004 with at least a part of the circuit outside the body
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2210/101 Pleural cavity
• 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: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

In accordance with embodiments of the present invention, a debris removal system is provided for a body-space drainage system having one or more body tubes with a body tube lumen disposed therein. The debris-removal system comprises a cleaning member, a collapsible sheath, and a coupler. The cleaning member is an elongated member wherein the distal end is adapted to enter the body tube lumen at or near the body-tube proximal end and adapted to be advanced distally at least a portion of a length of the body tube lumen. The collapsible sheath is adapted to contain at least a portion of the cleaning member that is not contained within the body tube lumen. The collapsible sheath is flexible so as to allow external digital manipulation of the cleaning member proximal end within of the collapsible sheath, while retaining the sterile environment of the body-space drainage system.

Claims

1. A debris-removal system for a body-space drainage system having one or more body tubes, each body tube having a body-tube distal end and a body-tube proximal end with a body tube lumen disposed therein, the debris-removal system comprising:

a cleaning member;

a collapsible sheath; and

a coupler, wherein the cleaning member is an elongated member having a cleaning member distal end and a cleaning member proximal end, the cleaning member distal end adapted to enter the body tube lumen at or near the body-tube proximal end and adapted to be advanced distally at least a portion of a length of the body tube lumen, the collapsible sheath adapted to contain at least a portion of the cleaning member that is not contained within the body tube lumen, the collapsible sheath being flexible so as to allow external digital manipulation of the cleaning member proximal end within of the collapsible sheath.

2. The debris-removal system of claim 1, wherein the collapsible sheath is adapted for permitting advancement, retraction and manipulation of the cleaning member within the body tube lumen from outside of the collapsible sheath.

3. The debris-removal system of claim 1, wherein the collapsible sheath is adapted to contain a fully retracted cleaning member.

4. The debris-removal system of claim 1, wherein the collapsible sheath adapted to couple at or near the proximal end of the body tube in fluid tight and sterile seal engagement with the body tube lumen.

5. The debris-removal system of claim 1, wherein the cleaning member is adapted to be advanced and retracted within the body tube lumen with-out breaking the sterile seal engagement.

6. The debris-removal system of claim 1, wherein the coupler comprises:

a body tube port adapted to couple with the body tube;

a canister tube port adapted to couple with the canister tube; and

a collapsible sheath port adapted to couple the collapsible sheath, wherein the coupler defines a passage in communication with the body tube port, the canister tube port and the collapsible sheath port, the passage adapted to receive the cleaning member.

7. The debris-removal system of claim 1, wherein the coupler is adapted to provide a removable coupling between the debris-removal system and the drainage system.

8. The debris-removal system of claim 1, wherein the cleaning member is a flexible filament.

9. The debris-removal system of claim 8, wherein the flexible filament is selected from a list consisting of semi-rigid wire, plastic rod, and tubing.

10. The debris-removal system of claim 8, wherein the flexible filament is adapted to mechanically clean the body tube lumen using mechanical dislodgment of the debris, the flexible filament being sufficiently flexible to traverse the curvature of the body tube lumen and sufficiently rigid so as to advance through the body tube lumen by manipulation from about the cleaning member proximal end and to dislodge and/or break up foreign matter within the body tube lumen as it makes contact with the foreign matter.

11. The debris-removal system of claim 8, wherein the cleaning member distal end comprises a cleaning member distal tip adapted to provide a rough abrasive surface so as to assist in dislodging foreign matter within the body tube lumen.

12. The debris-removal system of claim 8, wherein the debris-removal system further comprises a filament manipulation device removably coupled with the cleaning member proximal end and adapted to impart vibratory excitation thereto.

13. The debris-removal system of claim 8, wherein the collapsible sheath comprises a collapsible sheath proximal end adapted to couple with the cleaning member proximal end, the debris-removal system further comprising a filament manipulation device removably coupled with the collapsible sheath proximal end.

14. The debris-removal system of claim 12, wherein the filament manipulation device comprises an ultrasonic transducer that couples sonic energy to the cleaning member.

15. The debris-removal system of claim 8, wherein the debris-removal system further comprises a filament manipulation device removably coupled with the cleaning member proximal end, the filament manipulation device adapted to couple with the collapsible sheath proximal end and impart a circulatory motion to the cleaning member.

16. The debris-removal system of claim 15, wherein the collapsible sheath proximal end comprises a rotatable coupling adapted to couple the cleaning member with the manipulation device, the rotatable coupling adapted to provide a fluid and sterile seal while allowing the manipulation member to rotate the cleaning member.

17. The debris-removal system of claim 8, wherein the debris-removal system further comprises a tubular filament comprising an elongated tubular filament having a tubular filament proximal end, tubular filament distal end, and a filament lumen there through, the filament lumen defining a flow path to and/or from the tubular filament distal end, the tubular filament being sufficiently flexible to traverse curvature of the body tube lumen, but is sufficiently rigid so as to advance through the body tube lumen by pushing from the proximal end and to dislodge and/or break up foreign matter within the body tube lumen.

18. The debris-removal system of claim 17, wherein the filament lumen is adapted to provide a suction or vacuum path for the collection and removal of the dislodged debris, the tubular filament distal end adapted for coupling with a vacuum source and adapted to extract foreign material.

19. The debris-removal system of claim 17, wherein the debris-removal system is adapted to be coupled to a chest tube in a closed-suction tube system to drain blood and fluid and air from the chest.

20. The debris-removal system of claim 18, wherein the tubular filament distal end comprises an angular tip.

21. The debris-removal system of claim 17, wherein the debris-removal system further comprises a fluid source, the filament lumen adapted for expelling fluid from the tubular filament distal end.

22. The debris-removal system of claim 21, wherein the fluid source is adapted to supply fluid expelled at the tubular filament distal end at a predetermined pressure to mechanically dislodge and/or break up the foreign material.

23. The debris-removal system of claim 22, wherein the fluid source is adapted to supply fluid with sonic energy.

24. The debris-removal system of claim 21, wherein the fluid source is adapted to provide fluid comprising a solution adapted to assist in the dislodgment, dissolution and/or breakup of the foreign matter.

25. The debris-removal system of claim 21, wherein the fluid is a therapeutic agent selected from a list comprising antibiotic agents and anti-neoplastic agents.

26. The debris-removal system of claim 1, wherein the cleaning member is a tubular filament comprising a tubular filament distal end having an expandable portion coupled to a filament lumen, the expandable portion adapted to have a relaxed state in which the distal end has a minimal profile and an expanded state wherein the distal end has an enlarged profile, the expandable debris-removal system further comprising:

an inflatable fluid delivery system adapted to communicate inflation fluid to the expandable portion, the expandable portion adapted to expand by the advancement of inflation fluid from an fluid delivery system, through the lumen to the expandable portion, the inflation fluid controlled at the tubular member proximal end, wherein the expandable portion is the distal tip adapted to expand under fluid pressure and recoil back to substantially the original position upon withdrawal of the fluid pressure.

27. The debris-removal system of claim 26, wherein the expanded portion is adapted to fully occlude the body tube lumen when in the expanded state.

28. The debris-removal system of claim 27, wherein the inflatable fluid delivery system comprises a reservoir adapted to be coupled to the lumen at the proximal end of the cleaning member.

29. The debris-removal system of claim 28, wherein the reservoir comprises an elastic bulb, balloon or fluid-filled syringe coupled to the cleaning member through a coupling.

30. The debris-removal system of claim 28, wherein the fluid reservoir is provided within the collapsible sheath.

31. The debris-removal system of claim 26, wherein the expandable portion comprises an arrowhead or umbrella-shaped profile.

32. The debris-removal system of claim 26, wherein the expandable portion is along a portion of the length of the distal end, in fluid communication with the tubular filament lumen and adapted to expand upon presented with fluid pressure, to a larger diameter than a relaxed state.

33. The debris-removal system of claim 26, wherein the expandable portion is a plurality of expandable portion spaced a predetermined distance apart along the length of the cleaning member.

34. The debris-removal system of claim 26, wherein the distal end further comprises an elastic cord adapted to couple with the body tube distal end so as to provide a restoring force to reposition the cleaning member adjacent the body tube distal end.

35. The debris-removal system of claim 34, the distal end further comprising a cross-bar support adapted to couple the cleaning member to the body tube distal end.

36. The debris-removal system of claim 26, wherein the expandable portion comprises an umbrella-like expandable portion comprising of a plurality of struts and web, the umbrella-like expandable portion adapted to collapse to a narrow profile, and expand to substantially occlude the body tube lumen.

37. The debris-removal system of claim 36, wherein distal end further comprises an elastic cord adapted to couple with the body tube distal end so as to provide a restoring force to reposition the cleaning member adjacent the body tube distal end.

38. The debris-removal system of claim 26, wherein the expandable portion comprises a plurality of umbrella-like expandable portions comprising of a plurality of struts and webs, at least two of the plurality of expandable portions coupled to adjacent expandable portions with an elastic cord.

39. A method for removal of debris from a body tube, comprising:

coupling a debris removal system to the proximal end of a body tube, the debris removal system comprising a cleaning member, a sheath encasing the cleaning member, and a system coupler adapted to couple the debris removal system to the proximal end of the body tube, the cleaning member adapted for manipulation within the body tube to dislodge and/or break up debris within the body tube, the sheath adapted to maintain sterility of the elongated member;

manipulating the cleaning member from the sheath into the body space drainage tube proximal end to the debris location; and

manipulating the cleaning member within the body tube to dislodge and or break up the debris.

40. The method of claim 39, wherein the cleaning member is a tubular filament comprising a tubular filament distal end having an expandable portion coupled to a filament lumen, the expandable portion adapted to have a relaxed state in which the distal end has a minimal profile and an expanded state wherein the distal end has an enlarged profile, the expandable debris-removal system further comprising:

an inflatable fluid delivery system adapted to communicate inflation fluid to the expandable portion, the expandable portion adapted to expand by the advancement of inflation fluid from an fluid delivery system, through the lumen to the expandable portion, the inflation fluid controlled at the tubular member proximal end, wherein the expandable portion is the distal tip adapted to expand under fluid pressure and recoil back to substantially the original position upon withdrawal of the fluid pressure, the method further comprising;

advancing the expandable portion beyond the foreign material while in a relaxed state;

expanding the expandable portion to take on a diameter to at least partially occlude the body tube lumen; and

withdrawing the cleaning member from the body tube lumen so as to cause the expanded portion to abut and dislodge the foreign material, carrying the material distally to the proximal end.

41. The method of claim 39, wherein the cleaning member comprises a plurality of umbrella-like expandable portions comprising of a plurality of struts and webs, at least two of the plurality of expandable portions coupled to adjacent expandable portions with an elastic cord, the method further comprising:

pulling the proximal end of the cleaning member wherein each expandable portion expands and moves proximally a portion of the length of the lumen carrying the debris in a proximal direction;

releasing the cleaning member proximal end wherein the expandable portions collapse and move distally.

42. A debris removal system for use with a body tube having a distal end, comprising:

a cleaning member;

a sheath adapted to encase the cleaning member;

and a system coupler adapted to couple the debris removal system to the body tube distal end, the cleaning member adapted for manipulation within the body tube to dislodge and/or break up debris within the body tube.

43. A method of providing a system for removing debris from a body tube, comprising:

coupling a debris removal system to the proximal end of a body tube, the debris removal system comprising a cleaning member, a sheath encasing the cleaning member, and a system coupler adapted to couple the debris removal system to the proximal end of the body tube, the cleaning member adapted for manipulation within the body tube to dislodge and/or break up debris within the body tube, the sheath adapted to maintain sterility of the elongated member;

manipulating the cleaning member from the sheath into the body space drainage tube proximal end to the debris location; and

manipulating the cleaning member within the body tube to dislodge and or break up the debris.

44. The method of claim 43, wherein the cleaning member is a tubular filament comprising a tubular filament distal end having an expandable portion coupled to a filament lumen, the expandable portion adapted to have a relaxed state in which the distal end has a minimal profile and an expanded state wherein the distal end has an enlarged profile, the expandable debris-removal system further comprising:

an inflatable fluid delivery system adapted to communicate inflation fluid to the expandable portion, the expandable portion adapted to expand by the advancement of inflation fluid from an fluid delivery system, through the lumen to the expandable portion, the inflation fluid controlled at the tubular member proximal end, wherein the expandable portion is the distal tip adapted to expand under fluid pressure and recoil back to substantially the original position upon withdrawal of the fluid pressure, the method further comprising;

advancing the expandable portion beyond the foreign material while in a relaxed state;

expanding the expandable portion to take on a diameter to at least partially occlude the body tube lumen; and

withdrawing the cleaning member from the body tube lumen so as to cause the expanded portion to abut and dislodge the foreign material, carrying the material distally to the proximal end.

45. The method of claim 43, wherein the cleaning member comprises a plurality of umbrella-like expandable portions comprising of a plurality of struts and webs, at least two of the plurality of expandable portions coupled to adjacent expandable portions with an elastic cord, the method further comprising:

pulling the proximal end of the cleaning member wherein each expandable portion expands and moves proximally a portion of the length of the lumen carrying the debris in a proximal direction;

releasing the cleaning member proximal end wherein the expandable portions collapse and move distally.