Body-inserted tube cleaning

• US 9,962,233 B2
• Filed: 08/03/2015
• Issued: 05/08/2018
• 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., Davidner, Alan
• Primary Examiner(s): BLAN, NICOLE R
• Application Number:
  US14/816,356
• Publication Number:
  US 20160193011A1
• Time in Patent Office: 1,009 Days
• Field of Search: None
• 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 mechanically-actuated cleaning device for cleaning an endotracheal tube, the device comprising:

an elongate body comprising a distal end and a proximal end;

a suction channel extending along a portion of the elongate body;

one or more ports along the elongate body in communication with the suction channel;

a cleaning member positioned at or near the distal end of the elongate body,

wherein the cleaning member is movable between a collapsed configuration and an expanded configuration,

wherein the cleaning member, when in the expanded configuration, comprises a generally rounded profile,

wherein the cleaning member is non-inflatable,

wherein at least a portion of the cleaning member is configured to contact an interior surface of the endotracheal tube when the cleaning member is in the expanded configuration,

wherein the portion of the cleaning member that is configured to contact the interior surface of the endotracheal tube comprises a generally smooth surface;

an actuation assembly coupled to the proximal end of the elongate body, wherein the actuation assembly is configured to cause the cleaning member to transition between the collapsed configuration and the expanded configuration by mechanical manipulation of the actuation assembly; and

an elastomeric sheath configured to cover at least a portion of the elongate body.

2. The cleaning device of claim 1, wherein the elongate body comprises an inner shaft and an outer shaft, wherein a distal end of the outer shaft is coupled to a proximal end of the cleaning member, wherein a distal end of the inner shaft is coupled to a distal end of the cleaning member, and wherein the mechanical manipulation of the actuation assembly causes movement of the inner shaft relative to the outer shaft so as to cause the cleaning member to transition between the collapsed configuration and the expanded configuration.

3. The cleaning device of claim 1, wherein the cleaning member comprises a single wiper member.

4. The cleaning device of claim 1, further comprising a second cleaning member spaced apart from the cleaning member and having a different cross-sectional profile than the cleaning member.

5. The cleaning device of claim 1, wherein an outer diameter of the elongate body is between 2.5 mm and 3.5 mm.

6. The cleaning device of claim 1, wherein the cleaning member comprises a coating.

7. The cleaning device of claim 6, wherein the coating comprises one or more materials selected from the group consisting of:

an anti-bacterial agent, a mucolytic agent, a sterilant, an enzymatic cleaner, a germicide, an antiviral drug, and an antimicrobial drug.

8. The cleaning device of claim 1, wherein the cleaning member comprises a covered scaffold.

9. The cleaning device of claim 8, wherein the portion of the cleaning member that is configured to contact the interior surface of the endotracheal tube comprises a non-porous surface.

10. A mechanically-actuated cleaning device for cleaning a body-inserted medical tube, the device comprising:

an elongate body comprising a distal end and a proximal end;

a lumen extending along a portion of the elongate body;

one or more openings along the elongate body in communication with the lumen;

a cleaning member positioned along the elongate body,

wherein the cleaning member is configured to non-inflatably transition between an expanded configuration and a collapsed configuration,

wherein the cleaning member, when in the expanded configuration, comprises a rounded profile,

wherein at least a portion of the cleaning member is configured to contact an interior surface of the body-inserted medical tube when the cleaning member is in the expanded configuration and remove biofilm from an interior of the body-inserted medical tube upon withdrawal of the cleaning device,

wherein the portion of the cleaning member that is configured to contact the interior surface of the body-inserted medical tube comprises a generally smooth surface; and

an elastomeric bag configured to contain the biofilm after removal from the body-inserted medical tube.

11. The cleaning device of claim 10, wherein the elongate body comprises an inner shaft and an outer shaft, wherein a distal end of the outer shaft is coupled to a proximal end of the cleaning member, wherein a distal end of the inner shaft is coupled to a distal end of the cleaning member, and wherein the mechanical manipulation of an actuation assembly positioned at a proximal end of the elongate body causes movement of the inner shaft relative to the outer shaft so as to cause the cleaning member to transition between the collapsed configuration and the expanded configuration.

12. The cleaning device of claim 10, wherein the cleaning member comprises a wiper member.

13. The cleaning device of claim 10, further comprising a second cleaning member spaced apart from the cleaning member and having a different cross-sectional profile than the cleaning member.

14. The cleaning device of claim 10, wherein the cleaning member comprises a covered scaffold.

15. The cleaning device of claim 14, wherein the portion of the cleaning member that is configured to contact the interior surface of the body-inserted medical tube comprises a non-porous surface.

16. A mechanically-actuated cleaning device for cleaning a body-inserted medical tube, the device comprising:

an elongate body comprising a distal end and a proximal end;

a suction channel extending from the proximal end of the elongate body to an opening positioned along the elongate body to facilitate suction;

a cleaning member positioned along the elongate body,

wherein the cleaning member is configured to non-inflatably transition between an expanded configuration and a collapsed configuration,

wherein the cleaning member, when in the expanded configuration, comprises a rounded profile,

wherein at least a portion of the cleaning member is configured to contact an interior surface of the body-inserted medical tube when the cleaning member is in the expanded configuration and remove biofilm from an interior of the body-inserted medical tube upon withdrawal of the cleaning device

wherein the portion of the cleaning member that is configured to contact the interior surface of the body-inserted medical tube comprises a smooth surface; and

a sheath configured to prevent against contamination of at least a portion of the cleaning device.

17. The cleaning device of claim 16, wherein the cleaning member comprises a covered scaffold.

18. The cleaning device of claim 16, wherein the cleaning member comprises a covered scaffold and wherein the portion of the cleaning member that is configured to contact the interior surface of the body-inserted medical tube comprises a non-porous surface.