Mechanically-actuated endotracheal tube cleaning device

• US 8,468,637 B2
• Filed: 08/03/2010
• Issued: 06/25/2013
• 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): SCRUGGS, ROBERT J
• Application Number:
  US12/849,672
• Publication Number:
  US 20110023885A1
• Time in Patent Office: 1,057 Days
• Field of Search: 15/882, 15/883, 15/884, 15/77, 151/02, 152/30, 151/040.3, 151/040.5, 134/6, 134/148
• US Class Current: 15/104.05
• 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 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 an expansion member and an elastomeric sleeve extending along at least a portion of the exterior surface of the expansion member,

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

wherein a central portion of the elastomeric sleeve forms a removal member configured to engage an interior surface of an endotracheal tube when the cleaning member is 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; and

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

wherein said cleaning 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 cleaning member occurs mechanically.

2. The cleaning device of claim 1, wherein the expansion member comprises an expandable mesh scaffold, wherein said scaffold is configured to expand the elastomeric sleeve to form the removal member in the radially-expanded position.

3. The cleaning device of claim 1, wherein the actuation assembly is configured to permit a user to modify radial expansion of the cleaning 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 on an inside surface of an endotracheal tube.

4. 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 cleaning member between collapsed and expanded radial positions.

5. The cleaning device of claim 1, further comprising a first air gap along a proximal end of the elastomeric sleeve and a second air gap along a distal end of the elastomeric sleeve, wherein the first and second air gaps facilitate the passage of air across the cleaning member.

6. The cleaning device of claim 1, wherein the expansion member comprises one or more mechanically-expandable struts.

7. The cleaning device of claim 1, wherein said elongate body comprises at least one interior lumen that extends along said longitudinal axis to a distal end of the cleaning device.

8. The cleaning device of claim 7, wherein the at least one interior lumen is configured to receive a visualization scope, and wherein the distal tip of the cleaning device comprises a viewing window.

9. The cleaning device of claim 8, further comprising a scope retention assembly coupled to the actuation assembly, the scope retention assembly being configured to exert a static backward force on the visualization scope in the direction of the distal end of the cleaning device.

10. The cleaning device of claim 9, wherein a distal end of the visualization scope is maintained in generally constant contact with the viewing window of the cleaning device using the scope retention assembly.

11. The cleaning device of claim 9, wherein the scope retention assembly comprises an elastomeric sheath and a scope retention member.

12. The cleaning device of claim 11, wherein the elastomeric sheath is configured to stretch to allow the scope retention member to receive a locking member disposed on the visualization scope, thereby providing the static backward force on the visualization scope.

13. The cleaning device of claim 1, wherein the ratio of the width of the removal member to the overall length of the elastomeric sleeve is between about 1:

5 and about 2;

5.

14. The cleaning device of claim 1, wherein the ratio of the width of the apex to the width of the base of the removal member is between about 1:

3 and about 1;

4.

15. The cleaning device of claim 1, wherein a width of the base of the removal member is between about 0.10 and about 0.80 inches.

16. The cleaning device of claim 1, wherein a length of the elastomeric sleeve decreases by about 15% to about 30% when the cleaning member is moved from the radially-collapsed position to radially-expanded position.

17. The cleaning device of claim 1, wherein the removal member comprises a generally disc-shape when the cleaning member is in the radially-expanded position.

18. The cleaning device of claim 1, wherein the removal member comprises a generally diamond shape when the cleaning member is in the radially-expanded position.

19. The cleaning device of claim 1, wherein the removal member comprises a generally smooth apex when the expandable structure is in the radially-expanded position, said apex being configured to at least partially contact an inside surface of the endotracheal tube.

20. The cleaning device of claim 1, wherein at least a portion of the elastomeric sleeve is configured to radially expand together with the expansion member when the expansion member moves from the radially-collapsed position to the radially-expanded position.