Methods for cleaning endotracheal tubes

• US 8,382,908 B2
• Filed: 02/05/2010
• 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): Kornakov, Michael
• Assistant Examiner(s): BLAN, NICOLE R
• Application Number:
  US12/701,421
• Publication Number:
  US 20100199999A1
• Time in Patent Office: 1,117 Days
• Field of Search: None
• US Class Current: 134/8
• 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 for the purpose of increasing the available space for airflow or to prevent the build up of materials that may constrict airflow or be a potential nidus for infection. In one embodiment, a method for cleaning endotracheal tubes comprises inserting a cleaning device within an endotracheal tube while a cleaning member is in a compressed position, radially expanding the cleaning member to an expanded position within the endotracheal tube, and withdrawing the cleaning device from the endotracheal tube with the cleaning member in the expanded position.

Claims

1. A method for removing biofilm from an interior wall of an endotracheal tube, comprising:

providing a non-inflatable, mechanically-actuated cleaning device configured to remove biofilm from an interior wall of an endotracheal tube, wherein the endotracheal tube is inserted into a native airway of a patient and coupled to an external ventilator;

wherein said cleaning device comprises an elongate body, a mesh scaffold, a removal member and an actuation assembly;

wherein the removal member comprises an outer covering, said outer covering being positioned at least partially along an outside of the mesh scaffold;

wherein the elongate body comprises a distal end, a proximal end and a longitudinal axis,

wherein the mesh scaffold is positioned at the distal end of the elongate body, and

wherein the removal member is coupled to the mesh scaffold;

wherein the removal member comprises a smooth outer periphery;

inserting the distal end of the cleaning device into the endotracheal tube while the mesh scaffold is in a collapsed position;

mechanically actuating the mesh scaffold using said actuation assembly to expand said mesh scaffold from the collapsed position to an expanded position, thereby expanding the removal member to contact the biofilm;

wherein the removal member comprises a rounded or curvate shape when in the expanded position;

withdrawing the cleaning device from said endotracheal tube while maintaining contact between the removal member and the biofilm to dislodge said biofilm; and

removing said cleaning device from the patient.

2. The method of claim 1, wherein the smooth outer periphery is located along the outer covering, said smooth outer periphery being configured to contact biofilm disposed along the interior wall of the endotracheal tube when the mesh scaffold is moved to the expanded position.

3. The method of claim 1, wherein the removal member comprises one or more O-rings.

4. The method of claim 1, wherein the mesh scaffold is configured to allow airflow through the endotracheal tube in the collapsed position and the expanded position.

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

6. The method of claim 1, wherein the mesh scaffold comprises a unitary structure with the outer covering.

7. The method of claim 1, further providing a visualization element for viewing the interior wall of the endotracheal tube.

8. The method of claim 7, wherein the visualization element is inserted through a lumen of the elongate body.

9. The method of claim 1, further comprising aspirating biofilm from an interior of the endotracheal tube.

10. The method of claim 9, wherein said aspirating of biofilm occurs prior to inserting the distal end of the cleaning device into the endotracheal tube.

11. The method of claim 1, further comprising irrigating at least a portion of the interior wall of the endotracheal tube with a treatment fluid.

12. A method for cleaning an inside surface of an endotracheal tube without removing the endotracheal tube from a native airway of a patient, the method comprising:

positioning the patient in a semi-upright position;

delivering oxygen through the endotracheal tube using a ventilator for a predetermined time period;

aspirating an interior of the endotracheal tube using an aspiration instrument;

providing an endotracheal tube cleaning device having a radially expandable cleaning member, said cleaning member comprising a removal member;

wherein the removal member comprises a covering positioned at least partially along an exterior portion of the removal member, said covering comprising a generally smooth exterior surface;

determining a deployment depth for the endotracheal tube cleaning device based at least in part on the length of the endotracheal tube;

locking a movable stop on the endotracheal tube cleaning device at an axial position that causes deployment of the cleaning member at the determined deployment location within the endotracheal tube;

locking a movable stop on the endotracheal tube cleaning device at an axial position that causes deployment of the cleaning member at the determined deployment depth within the endotracheal tube;

inserting the endotracheal tube cleaning device into the endotracheal tube according to the determined deployment depth;

mechanically actuating the cleaning member from a radially-collapsed position to a radially-expanded position by manipulating an actuation assembly of the endotracheal tube cleaning member;

wherein mechanically actuating the cleaning member causes at least a portion of the generally smooth exterior surface of the covering of the removal member to engage an interior wall of the endotracheal tube; and

withdrawing the endotracheal tube cleaning device from the endotracheal tube in order to remove biofilm from the interior wall of the endotracheal tube; and

wherein the removal member comprises a rounded or curvate shape when in the radially-expanded position.

13. The method of claim 12, wherein the removal member comprises one or more O-rings.

14. The method of claim 12, wherein the cleaning member comprises a mechanically-expandable mesh scaffold.

15. The method of claim 12, further comprising providing a visualization element for viewing the interior wall of the endotracheal tube.

16. The method of claim 12, further comprising aspirating biofilm from an interior of the endotracheal tube.

17. A method for removing biofilm from an interior wall of an endotracheal tube, comprising:

providing a non-inflatable, mechanically-actuated cleaning device configured to remove biofilm from an interior wall of an endotracheal tube, wherein the endotracheal tube is inserted into a native airway of a patient and is coupled to an external ventilator;

providing a visualization element for viewing at least a portion of the interior wall of the endotracheal tube;

wherein said cleaning device comprises an elongate body, a scaffold, a removal member and an actuation assembly;

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

wherein the removal member comprises a generally smooth outer periphery;

wherein the elongate body comprises a distal end, a proximal end and a longitudinal axis,

wherein the scaffold is positioned at the distal end of the elongate body, and

wherein the removal member is coupled to the scaffold;

inserting the distal end of the cleaning device into the endotracheal tube while the scaffold is in a collapsed position;

mechanically actuating the scaffold with said actuation assembly to expand said scaffold from the collapsed position to an expanded position, thereby expanding the removal member to contact the biofilm;

wherein the removal member comprises a rounded or curvate shape when in the expanded position;

withdrawing the cleaning device from said endotracheal tube while maintaining contact between the removal member and the biofilm to dislodge said biofilm; and

removing said cleaning device from said patient.

18. The method of claim 17, wherein the generally smooth outer periphery is located along an exterior surface of the outer covering.

19. The method of claim 17, wherein the visualization element is provided through a lumen of the elongate body of the cleaning device.

20. The method of claim 17, further comprising viewing the interior wall of the endotracheal tube during insertion of the cleaning device.

21. The method of claim 17, further comprising viewing the interior wall of the endotracheal tube during withdrawal of the cleaning device.