Medical tube cleaning apparatus

• US 8,458,844 B2
• Filed: 08/04/2010
• Issued: 06/11/2013
• 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:
  US12/850,476
• Publication Number:
  US 20110023886A1
• Time in Patent Office: 1,042 Days
• Field of Search: 15/882, 15/883, 15/884, 15/77, 151/02, 152/30, 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 medical tube cleaning device, comprising:

an elongated member having a proximal end and a distal end, said elongated member comprising at least one lumen extending within an interior of said elongated member along at least a portion of a length of said elongated member;

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

an outer sleeve positioned along an exterior surface of, and at least partially along a longitudinal length of, the expansion member, wherein the outer sleeve is configured to form a removal member to engage an interior surface of a medical tube when the expansion member is in the radially-expanded position;

wherein the removal member is configured to apply radial pressure to the interior surface of the medical tube with a pressure sufficient to remove biofilm without causing invagination of said biofilm;

wherein said removal member formed by the outer sleeve is configured to contact and remove debris collected on an interior surface of the medical tube when said cleaning device is moved relative to the medical tube;

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

wherein the at least one interior lumen is configured to receive a visualization scope;

wherein the expansion member is configured to move between the radially-collapsed position and the radially-expanded position by manipulation of the actuation assembly; and

wherein expansion and collapse of the expansion member occurs mechanically.

2. The cleaning device of claim 1, wherein a length of the outer sleeve decreases, and the removal member comprises a generally smooth apex when the expansion member is in the radially-expanded position, said generally smooth apex being configured to contact an inside surface of the medical tube.

3. The cleaning device of claim 2, wherein the length of the outer sleeve when the expansion member is in the radially-expanded position is about 10% to 40% shorter than the length of the outer sleeve when the expansion member is in the radially-collapsed position.

4. The cleaning device of claim 2, wherein the removal member comprises a disc-shape.

5. The cleaning device of claim 4, wherein the ratio of the width of the apex of the removal member to a base of the removal member is between about 1:

3 and about 1;

4.

6. The cleaning device of claim 1, wherein the removal member comprises a generally diamond, frisbee or plate shape.

7. The cleaning device of claim 1, wherein the length of the outer sleeve decreases by about 0.15 to about 0.60 inches upon expansion of the expansion member.

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

9. The cleaning device of claim 1, wherein the actuation assembly is configured to permit a user to selectively expand or collapse the expansion member in order to modify a pressure exerted by the at least one removal member on an inside surface of a medical tube.

10. The cleaning device of claim 1, wherein the elongated member comprises an inner shaft and an outer shaft, wherein movement of the inner shaft relative to the outer shaft moves the expansion member between radially collapsed and expanded positions.

11. The cleaning device of claim 1, further comprising a scope retention assembly coupled to the actuation assembly, the scope retention assembly configured to exert a static backward force on a visualization scope inserted within the at least one interior lumen in the direction of a distal end of the cleaning device, wherein the scope retention assembly comprises a scope sheath and a scope retention member.

12. The cleaning device of claim 11, wherein the scope 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 12, wherein the scope retention assembly helps to maintain a distal lens of the visualization scope in generally constant contact with a viewing window located along a distal end of the elongated member.

14. The cleaning device of claim 1, further comprising at least one air gap along each end of the outer sleeve, thereby allowing air to flow across the expansion member while the cleaning device is in use.

15. The cleaning device of claim 1, wherein the outer sleeve comprises an elastomeric sleeve.

16. A cleaning device for cleaning a medical tube, comprising:

an elongated member having a proximal end and a distal end, said elongated member comprising at least one lumen extending within an interior of said elongated member along at least a portion of a length of said elongated member;

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

an outer sleeve positioned along an outer surface of the expandable structure, wherein the outer sleeve is configured to form a removal member to engage an interior surface of a medical tube when the expandable structure is in the radially-expanded position;

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;

wherein the removal member is configured to apply a radial pressure to the interior surface of the medical tube in order to remove biofilm;

wherein said removal member formed by the outer sleeve is configured to contact and remove debris collected on an interior surface of the medical tube when said cleaning device is moved relative to the medical tube; and

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

wherein the expandable structure is configured to move between the radially-collapsed position and the radially-expanded position by manipulation of the actuation assembly; and

wherein expansion and collapse of the expandable structure occurs mechanically.

17. The cleaning device of claim 16, wherein a length of the outer sleeve decreases, and the removal member comprises a generally smooth apex when the expandable structure is in the radially-expanded position, said apex being configured to contact an inside surface of the medical tube.

18. The cleaning device of claim 16, wherein the length of the outer sleeve when the expandable structure is in the radially-expanded position is about 10% to 40% shorter than the length of the outer sleeve when the expandable structure is in the radially-collapsed position.

19. The cleaning device of claim 16, wherein the removal member comprises a disc-shape.

20. The cleaning device of claim 16, wherein the removal member comprises a generally diamond, frisbee or plate shape.