VISUALIZED ENDOTRACHEAL TUBE PLACEMENT SYSTEMS

• US 20130030249A1
• Filed: 10/05/2012
• Published: 01/31/2013
• Est. Priority Date: 02/06/2009
• Status: Active Grant

• Current Assignee: SunMed Group Holdings LLC
• Original Assignee: Endoclear LLC (Avanos Medical, Inc.)
• Inventors: Gracy, James M., Vazales, Brad E., Colwell, Clifton P., Berky, Craig B., Davidner, Alan, Bertolero, Arthur, Watson, Ken, Morejohn, Dwight, Griffin, Dwayne, Tefo, Richard
• Granted Patent: US 9,579,012 B2
• Time in Patent Office: Days
• US Class Current: 600/120
• 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, methods, and devices for facilitating insertion of an endotracheal tube and/or for verifying the position of the endotracheal tube within an airway of a patient with respect to an anatomical landmark of a patient are disclosed. Systems, methods, and devices for facilitating removal of debris from the distal airways of a patient under direct visualization are also disclosed.

Claims

1. A visualization device for confirming proper positioning and placement of an endotracheal tube within a patient without requiring the use of a laryngoscope or bronchoscope, the device comprising:

a visualization tube adapted to be inserted within an endotracheal tube, the visualization tube having a closed distal end, an open proximal end, and a lumen extending from the proximal end to the distal end;

wherein the visualization tube is sized to extend at least to the distal end of the endotracheal tube;

wherein the lumen of the visualization tube is sized and shaped to removably receive a visualization scope;

wherein the closed distal end of the visualization tube comprises a window;

wherein the visualization tube comprises at least one centering assembly mounted on an outer surface of the visualization tube, the at least one centering assembly comprising two or more flexible arms adapted to expand to conform to an inner wall of the endotracheal tube, thereby centering the visualization tube within the endotracheal tube;

a coupling assembly adapted to couple the visualization tube to the endotracheal tube; and

a scope retention assembly coupled to the coupling assembly;

wherein the scope retention assembly comprises a stretchable elastomeric sleeve and a scope retention member attached to a proximal end of the elastomeric sleeve adapted to interface with a locking member coupled to a visualization scope;

wherein the elastomeric sleeve is adapted to be stretched to allow the scope retention member of the scope retention assembly to engage the locking member, thereby exerting a static force on the visualization scope in the direction of the closed distal end of the visualization tube upon release of the elastomeric sleeve.

2. The visualization device of claim 1, wherein the scope retention member comprises a slot, wherein the slot is sized and shaped to receive the visualization scope.

3. The visualization device of claim 1, wherein the locking member is integrally formed on a scope retainer sleeve that is coupled to the visualization scope.

4. The visualization device of claim 1, wherein the visualization tube comprises one or more sensors configured to detect one or more of the following:

carbon dioxide levels, the presence of selected bacteria of interest, moisture levels, or respiratory parameters.

5. The visualization device of claim 1, wherein the coupling assembly comprises at least one accessory port.

6. The visualization device of claim 5, wherein the at least one accessory port comprises an oxygen port adapted to connect to an oxygen line or to a ventilator and an access port adapted to receive a stylet or obturator.

7. The visualization device of claim 1, wherein the visualization tube comprises a bend radius that approximates the bend radius of an endotracheal tube.

8. The visualization device of claim 1, wherein the visualization tube has an outer diameter of less than 2 mm, wherein the window comprises clear polycarbonate material, wherein the thickness of the window is less than 0.012 inches, wherein the visualization tube is disposable, wherein the elastomeric sleeve can be stretched at least one inch from a relaxed state, wherein the at least one centering assembly is automatically adjustable to accommodate endotracheal tubes of varying diameter, wherein the at least one centering assembly comprises a plurality of spaced-apart centering assemblies, and/or wherein the coupling assembly comprises a cinching nut.

9. A visualization system for proper positioning or placement of an endotracheal tube within a patient without requiring the use of a laryngoscope or bronchoscope, the system comprising:

the visualization device of claim 1; and

an endotracheal tube cleaning device configured to be inserted into an endotracheal tube of a patient either before or after a distal airway cleaning device has been positioned and subsequently removed from one or more distal airways of the patent, said endotracheal tube cleaning device 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;

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

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

a visualization channel within the lumen of the elongated member sized and configured to receive the visualization scope;

wherein the one or more removal members of the cleaning device are configured to engage an interior surface of an endotracheal tube when the expandable structure is in the radially-expanded position; and

wherein the one or more removal members are configured to contact and remove debris collected on an interior surface of the endotracheal tube when said cleaning device is moved relative to the endotracheal tube.

10. The system of claim 9, wherein the expandable structure of the endotracheal tube cleaning device is mechanically-expandable.

11. The system of claim 10, wherein the expandable structure comprises a mesh scaffold or expandable struts, wherein the expandable structure comprises an outer sleeve positioned along at least a portion of an exterior surface of the expandable structure, and wherein the at least a portion of the outer sleeve is configured to radially expand together with the expandable structure when the expandable structure moves from the radially-collapsed position to the radially-expanded position.

12. The system of claim 9, further comprising a distal airway cleaning device for removing debris from one or more distal airways of a patient, said distal airway cleaning device comprising:

a suction catheter comprising a main suction lumen and a distal end configured to facilitate steering of the suction catheter within an airway of the patient;

a visualization channel disposed within the main suction lumen of the suction catheter sized and shaped to receive a visualization scope,

wherein the visualization channel comprises a window at a closed distal end of the visualization channel; and

a control handle configured for one-handed operation of the distal airway cleaning device,

wherein the suction catheter comprises a distal angle and a deflection mechanism to facilitate access to all areas of the bronchus and lungs.

13. The system of claim 12, wherein the main suction lumen of the suction catheter further comprises an irrigation channel, said irrigation channel being configured to clean the window at the distal end of the visualization channel and/or to deliver one or more fluids to the distal airways of the patient.

14. The system of claim 12, wherein the distal airway cleaning device is configured to be operated in a closed suction system.

15. The system of claim 12, wherein an elongate shaft of the suction catheter comprises an endotracheal tube cleaning member comprising one or more removal members configured to expand into contact with an interior wall of an endotracheal tube, wherein the endotracheal tube cleaning member comprises a mechanically expandable structure, and/or wherein the endotracheal tube cleaning member comprises an inflatable structure.

16. A system for providing visualized confirmation of proper positioning and cleaning of an endotracheal tube within a patient, the system comprising:

a visualization device adapted to provide visualized confirmation of proper positioning of an endotracheal tube within a patient, the visualization device comprising;

a visualization tube adapted to be inserted within the endotracheal tube, the visualization tube having a closed distal end, an open proximal end, and a lumen extending from the proximal end to the distal end;

wherein the lumen of the visualization tube is sized and shaped to removably receive a visualization scope;

wherein the closed distal end of the visualization tube comprises a window;

wherein the visualization tube comprises at least one centering assembly mounted on an outer surface of the visualization tube, the at least one centering assembly comprising two or more flexible wings adapted to expand to conform to an inner wall of the endotracheal tube, thereby centering the visualization tube within the endotracheal tube; and

an endotracheal tube cleaning device configured to be inserted into an endotracheal tube of a patient either before or after the self-contained distal airway cleaning device has been positioned and subsequently removed from one or more distal airways of the patent, said endotracheal tube cleaning device 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 structure positioned along the elongated member, said structure being adapted to selectively move between a radially-collapsed position and a radially-expanded position;

an actuation assembly coupled to the proximal end of the elongated member, the actuation assembly being configured to control the expansion and collapse of the expandable structure; and

a visualization channel within the lumen of the elongated member sized and configured to receive the visualization scope;

wherein the one or more removal members of the cleaning device are configured to engage an interior surface of an endotracheal tube when the expandable structure is in the radially-expanded position; and

wherein the one or more removal members are configured to contact and remove debris collected on an interior surface of the endotracheal tube when said cleaning device is moved relative to the endotracheal tube.

17. The system of claim 16, further comprising a distal airway cleaning device for removing debris from one or more distal airways of a patient, said distal airway cleaning device comprising:

a suction catheter comprising a main suction lumen and a distal end configured to facilitate steering of the suction catheter within an airway of the patient;

a visualization channel disposed within the main suction lumen of the suction catheter sized and shaped to receive a visualization scope,

wherein the visualization channel comprises a window at a closed distal end of the visualization channel;

a control handle configured for one-handed operation of the distal airway cleaning device;

18. The system of claim 17, wherein the main suction lumen of the suction catheter further comprises an irrigation channel, said irrigation channel being configured to clean the window at the distal end of the visualization channel and/or to deliver one or more fluids to the distal airways of the patient.

19. The system of claim 17, wherein the distal airway cleaning device is configured to be operated in a closed suction system.

20. The system of claim 16, further comprising an endotracheal tube adapter comprising multiple inlet ports configured to allow the distal airway cleaning device and the endotracheal tube cleaning device to be inserted within the endotracheal tube simultaneously.

21. The system of claim 20, further comprising a ventilation port configured to be coupled to an oxygen supply to provide a continuous supply of oxygen during cleaning procedures performed by the distal airway cleaning device or the endotracheal tube cleaning device.

22. The system of claim 17, wherein an elongate shaft of the suction catheter comprises an endotracheal tube cleaning member comprising one or more removal members configured to expand into contact with an interior wall of an endotracheal tube, wherein the one or more removal members are configured to remove biofilm from the interior wall of the endotracheal tube, wherein the endotracheal tube cleaning member comprises a mechanically expandable structure, wherein the distal end of the suction catheter is pre-curved, wherein the distal end of the suction catheter is not pre-curved but is steerable, and/or wherein the endotracheal tube cleaning member comprises an inflatable structure.

23. The system of claim 16, wherein the expandable structure of the endotracheal tube cleaning device comprises a mesh scaffold or expandable struts, wherein the expandable structure comprises an outer sleeve positioned along at least a portion of an exterior surface of the expandable structure, and wherein at least a portion of the outer sleeve is configured to radially expand together with the expandable structure when the expandable structure moves from the radially-collapsed position to the radially-expanded position.