Devices for cleaning endotracheal tubes

• US 8,381,345 B2
• Filed: 03/26/2010
• Issued: 02/26/2013
• Est. Priority Date: 02/06/2009
• Status: Active Grant

• Current Assignee: SunMed Group Holdings LLC
• Original Assignee: Endoclear LLC (Avanos Medical, Inc.)
• Inventors: Vazales, Brad E., Bertolero, Arthur, Watson, Ken, Gracy, James M., Colwell, Clifton P., Berky, Craig B., Davidner, Alan
• Primary Examiner(s): GUIDOTTI, LAURA COLE
• Application Number:
  US12/748,326
• Publication Number:
  US 20100199448A1
• Time in Patent Office: 1,068 Days
• Field of Search: 151/040.5, 151/041.6, 128/207.14
• US Class Current: 15/104.05
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/122 using cleaning tools, e.g. brushes
• CPC Class Codes: A61B 1/126 provided with means for cleaning in-use
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• 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 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 2202/203 Bacteria
• CPC Class Codes: A61M 2209/10 Equipment for cleaning
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• 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

Systems, devices, and methods are disclosed for the cleaning of an endotracheal tube while a patient is being supported by a ventilator connected to the endotracheal tube. According to some embodiments, a mechanically-actuated non-inflatable cleaning device for scraping debris (e.g., biofilm) from an interior wall of an endotracheal tube is provided. In one embodiment, the cleaning device comprises an elongated member having a proximal end and a distal end and a mechanically-expandable scaffold positioned along the distal end of the elongated member. In one embodiment, the mechanically-expandable scaffold comprises one or more removal members configured to engage an interior surface of an endotracheal tube when the scaffold is in a radially-expanded position and to remove debris from the interior surface of the endotracheal tube when the device is withdrawn from the endotracheal tube.

Claims

1. A non-inflatable mechanically-actuated cleaning device for removing biofilm from an interior wall of an endotracheal tube, comprising:

an elongate body having a distal end, a proximal end and a longitudinal axis,

wherein the distal end comprises a distal tip,

a cleaning member positioned at the distal end of the elongate body, said cleaning member comprising a removal member and a collection member,

wherein the removal member comprises an outer covering, wherein an entire length of said outer covering comprises a smooth outer surface;

wherein said removal member is selectively movable between a radially-collapsed position and a radially-expanded position,

wherein at least a portion of the outer covering is configured to engage an interior surface of an endotracheal tube when in the radially-expanded position,

wherein said removal member is configured to remove biofilm collected on the interior surface of an endotracheal tube when said removal member is moved along the longitudinal axis of the elongate body,

wherein said collection member is configured to collect at least a portion of removed biofilm, and

wherein said collection member is configured to allow airflow through the endotracheal tube; and

a non-inflatable actuation assembly coupled to the proximal end of the elongate body;

wherein said removal member is movable between said radially-collapsed position and said radially-expanded position by manipulation of the actuation assembly, and

wherein the expansion and collapse of the removal member occurs mechanically.

2. The cleaning device of claim 1, wherein the collection member comprises an expandable scaffold, wherein said scaffold is configured to expand the removal member into the radially-expanded position.

3. The cleaning device of claim 2, wherein the outer covering is either separate from or forms a generally unitary structure with the expandable scaffold.

4. The cleaning device of claim 1, wherein the collection member comprises a mesh.

5. The cleaning device of claim 1, wherein the actuation assembly is configured to permit a user to modify radial expansion of the removal member in order to modify a pressure exerted by the removal member on an inside surface of an endotracheal tube or on a biofilm deposited thereon.

6. The cleaning device of claim 1, wherein the elongate body comprises an inner shaft and an outer shaft, wherein movement of the inner shaft relative to the outer shaft moves the removal member between collapsed and expanded radial positions.

7. The cleaning device of claim 1, wherein the outer covering comprises one or more O-rings.

8. The cleaning device of claim 1, wherein the outer covering extends only partially along a length of the cleaning member.

9. The cleaning device of claim 1, wherein the outer covering extends completely along a length of the cleaning member.

10. The cleaning device of claim 1, wherein said elongate body comprises at least one interior lumen that extends at least partially along said longitudinal axis.

11. The cleaning device of claim 10, wherein the at least one interior lumen is configured to receive at least one of a visualization scope, an aspiration conduit, an irrigation conduit, a light therapy source, or a ventilation conduit.

12. The cleaning device of claim 1, wherein the distal tip comprises a viewing window.

13. The cleaning device of claim 1, wherein the actuation assembly is configured for one-handed manipulation of the cleaning device during a cleaning procedure.

14. The cleaning device of claim 1, wherein the cleaning device is configured for single pass cleaning.

15. The cleaning device of claim 1, wherein the removal member is positioned along an exterior surface of the collection member.

16. The cleaning device of claim 1, wherein the removal member and the collection member are separate items that are permanently or removably attached to each other.

17. A cleaning device for clearing debris from an interior wall of a medical tube, comprising:

an elongated member having a proximal end and a tip along its distal end, said elongated member comprising at least one lumen extending within its interior along at least along a portion of a length of said elongated member;

a mechanically-expandable scaffold positioned along the elongated member, said scaffold being adapted to selectively move between a radially-collapsed position and a radially-expanded position, the scaffold comprising;

one or more removal members extending radially outwardly from an outer surface of the scaffold;

wherein the one or more removal members comprise a covering, an entire length of said covering that is configured to contact an interior wall of a medical tube comprising a rounded profile when the scaffold is in the radially-expanded position;

wherein said one or more removal members are configured to contact and remove debris collected on an interior wall of a medical tube when said cleaning device is moved relative to the medical tube;

an actuation assembly coupled to the proximal end of the elongated member;

wherein the scaffold is configured to move between the radially-collapsed position and the radially-expanded position by manipulation of the actuation assembly; and

wherein expansion and collapse of the scaffold occurs mechanically.

18. The cleaning device of claim 17, further comprising a collection member configured to collect at least a portion of removed biofilm.

19. The cleaning device of claim 17, wherein the scaffold comprises at least one layer of mesh.

20. The cleaning device of claim 17, wherein the actuation assembly is configured to permit a user to selectively expand or collapse the scaffold in order to modify a pressure exerted by the one or more removal members on an inside wall of an endotracheal tube.

21. The cleaning device of claim 17, wherein the elongated member comprises an inner shaft and an outer shaft, wherein movement of the inner shaft relative to the outer shaft moves the scaffold between radially collapsed and expanded positions.

22. The cleaning device of claim 17, wherein the removal member comprises one or more O-rings.

23. The cleaning device of claim 17, further comprising at least one port in the elongated member or the actuation assembly, said at least one port providing access to the interior lumen of the elongated member.

24. The cleaning device of claim 17, wherein the tip of the elongated member comprises a viewing window.

25. The cleaning device of claim 17, wherein the actuation assembly is configured for one-handed manipulation of the cleaning device during a cleaning procedure.

27. The cleaning device of claim 17, wherein the covering extends partially along a length of the scaffold.

28. The cleaning device of claim 17, wherein the covering extends completely along a length of the scaffold.

26. A mechanically-actuated non-inflatable cleaning device for scraping debris from an interior wall of a conduit, comprising:

an elongated member having a proximal end and a distal end,

a mechanically-expandable scaffold positioned along the distal end of the elongated member,

wherein said mechanically-expandable scaffold is adapted to move between a radially-collapsed position and a radially-expanded position,

wherein said scaffold comprises a removal member extending radially outwardly from an outer surface of the scaffold,

wherein said removal member comprises an outer covering, said outer covering extending at least partially along a length of the scaffold;

wherein said outer covering is continuous along a length that contacts an interior wall of a conduit when the scaffold is in the radially-expanded position;

wherein said removal member is configured to scrape debris collected on an interior wall of the conduit when said cleaning device is moved relative to the conduit;

wherein the scaffold comprises a mesh scaffold;

an actuation assembly coupled to the proximal end of the elongated member;

wherein the scaffold is configured to move between the radially-collapsed position and the radially-expanded position by manipulation of the actuation assembly; and

wherein the expansion and collapse of the scaffold occurs mechanically.