Methods for removing debris from medical tubes

• US 8,157,919 B2
• Filed: 08/04/2010
• Issued: 04/17/2012
• 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:
  US12/850,563
• Publication Number:
  US 20110023888A1
• Time in Patent Office: 622 Days
• Field of Search: None
• US Class Current: 134/8
• CPC Class Codes: A61B 1/00045 Display arrangement
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 1/0669 at proximal end of an endoscope
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 16/0418 with integrated means for changing the degree of curvature, e.g. for easy intubation
• CPC Class Codes: A61M 16/0427 with removable and re-insertable liner tubes, e.g. for cleaning
• CPC Class Codes: A61M 16/0431 with a cross-sectional shape other than circular
• 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 16/0472 : Devices for performing a tracheostomy
• CPC Class Codes: A61M 16/0484 : at the distal end
• 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 2016/0413 : with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2202/203 : Bacteria

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 mechanically-actuated endotracheal tube cleaning device is configured to removably receive a visualization member to provide cleaning of the endotracheal tube under direct visualization.

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, an expandable scaffold, an outer sleeve and an actuation assembly;

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

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

wherein the outer sleeve is positioned at least partially over an exterior surface of the scaffold;

decoupling the endotracheal tube from the external ventilator;

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

providing a visualization element configured to capture images of an interior of the endotracheal tube;

advancing the visualization element through a lumen of the elongate body of the cleaning device such that a distal end of the visualization element engages a distal tip of the cleaning device,

wherein the distal tip of the cleaning device comprises a viewing window,

wherein the cleaning device comprises a retention assembly configured to provide a static backward force on the visualization element within the lumen of the elongate body;

mechanically actuating the scaffold using said actuation assembly to expand said scaffold from the radially-collapsed position to a radially-expanded position, thereby expanding the outer sleeve to form a generally smooth removal member configured to contact and remove biofilm from the interior wall of the endotracheal tube;

withdrawing the cleaning device from the endotracheal tube while generally maintaining contact between the removal member and biofilm to dislodge at least a portion of said biofilm; and

removing said cleaning device from the patient, thereby removing biofilm from the endotracheal tube.

2. The method of claim 1, wherein the cleaning device comprises air gaps at the proximal and distal ends of the cleaning member, thereby allowing airflow through the scaffold during use.

3. The method of claim 1, wherein the visualization element comprises a fiberoptic visualization scope.

4. The method of claim 1, wherein the retention assembly comprises a stretchable elastomeric tube coupled to the proximal end of the elongate body and a first retention member coupled to the proximal end of the stretchable elastomeric tube.

5. The method of claim 4, further comprising stretching the elastomeric tube such that a second retention member disposed on the visualization element is received by a slot of the first retention member.

6. The method of claim 5, further comprising releasing the elastomeric tube, thereby providing the static backward force on the visualization element inserted within the lumen of the elongate body.

7. The method of claim 1, further comprising adjusting the position of the cleaning device within the endotracheal tube based, at least in part, on the images captured by the visualization element.

8. The method of claim 1, wherein the removal member comprises a disc-like removal member.

9. The method of claim 1, wherein the scaffold comprises a mesh scaffold.

10. The method of claim 1, wherein the outer sleeve comprises an elastomeric sleeve.

11. The method of claim 1, wherein the cleaning device removes at least 90% of the biofilm collected along the endotracheal tube.

12. The method of claim 1, further comprising verifying that the endotracheal tube has an inner diameter that is substantially equivalent to an unused endotracheal tube.

13. A method for removing biofilm from an interior wall of a medical tube, comprising:

providing a non-inflatable, mechanically-actuated cleaning device configured to remove debris from an interior wall of a medical tube;

wherein said cleaning device comprises an elongate body, an expandable member, an outer sleeve and an actuation assembly;

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

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

wherein the outer sleeve is positioned at least partially over an exterior surface of the expandable member;

inserting the distal end of the cleaning device into the medical tube while the expandable member is in a radially-collapsed position;

providing a visualization element configured to capture images of an interior of the medical tube;

advancing the visualization element through a lumen of the elongate body of the cleaning device such that a distal end of the visualization element engages a distal tip of the cleaning device,

wherein the distal tip of the cleaning device comprises a viewing window,

wherein the cleaning device comprises a retention assembly configured to provide a static backward force on the visualization element within the lumen of the elongate body;

mechanically actuating the expandable member using the actuation assembly to expand the expandable member from the radially-collapsed position to a radially-expanded position;

wherein radial expansion of the expandable member moves the outer sleeve radially outwardly to form a generally smooth removal member configured to contact and remove debris collected on the interior surface of the medical tube;

withdrawing the cleaning device from the medical tube along the longitudinal axis while generally maintaining contact between the removal member and debris to dislodge at least a portion of said debris; and

removing said cleaning device from the patient, thereby removing debris from the medical tube.

14. The method of claim 13, wherein the scaffold comprises a mesh scaffold.

15. The method of claim 13, wherein the retention assembly comprises:

a stretchable elastomeric tube coupled to the proximal end of the elongate body, and

a first retention member coupled to the proximal end of the stretchable elastomeric tube.

16. The method of claim 15, further comprising stretching the elastomeric tube such that a second retention member disposed on the visualization element is received by a slot of the first retention member.

17. The method of claim 16, further comprising releasing the elastomeric tube, thereby providing the static backward force on the visualization element inserted within the lumen of the elongate body.

18. The method of claim 13, further comprising adjusting the position of the cleaning device within the medical tube based on, at least in part, the at least one image captured by the visualization element.

19. The method of claim 13, wherein the removal member comprises a disc-like shape.

20. The method of claim 13, wherein the outer sleeve comprises an elastomeric sleeve.