AIRWAY CLEANING AND VISUALIZATION

• US 20130023729A1
• Filed: 03/28/2011
• Published: 01/24/2013
• 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, Davidner, Alan, Watson, Ken, Gracy, James M., Colwell, Clifton P., Berky, Craig B., Morejohn, Dwight, Griffin, Dwayne, Tefo, Richard
• Granted Patent: US 9,398,837 B2
• Time in Patent Office: Days
• US Class Current: 600/104
• 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

1-53. -53. (canceled)

54. A method of confirming proper positioning or placement of an endotracheal tube within a patient without requiring the use of a laryngoscope or bronchoscope and without disconnecting a patient from a ventilator, the method comprising:

coupling a visualization device to an endotracheal tube inserted within a patient using a coupling assembly;

wherein the visualization device comprises;

a visualization tube having a sealed distal end and an open proximal end;

wherein the distal end comprises a window; 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;

inserting a visualization scope within the visualization tube of the visualization device, the visualization scope comprising a locking member;

advancing the visualization device within the visualization tube until the distal end of the visualization device contacts the window of the visualization tube;

stretching the elastomeric sleeve to a position such that a receiving feature of the scope retention member aligns with the locking member of the visualization scope;

releasing the elastomeric sleeve, thereby exerting a static force on the visualization scope in the direction of the window at the distal end of the visualization tube; and

confirming a position of the distal end of the endotracheal tube within the airway of the patient from images captured by the visualization scope.

55. The method of claim 54, further comprising obtaining a recording of an image of the position of the distal end of the endotracheal tube with respect to the carina.

56. The method of claim 54, further comprising displaying images captured by the visualization scope on a display.

57. The method of claim 54, further comprising providing oxygen to the patient through an oxygen port, or ventilation to the patient through a ventilator port, of the coupling assembly such that oxygen flow is uninterrupted.

58. The method of claim 54, wherein the visualization scope comprises a fiber optic scope having imaging fibers and light fibers, and wherein the distal ends of the light fibers are positioned proximate to the distal ends of imaging fibers at an offset distance to reduce glare.

59. The method of claim 54, 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.

60. The method of claim 54, 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 coupling assembly comprises an access port adapted to receive a stylet or obturator, and/or wherein the coupling assembly comprises a cinching nut.

61. The method of claim 54, further comprising:

inserting an endotracheal tube cleaning device into the endotracheal tube, wherein the endotracheal tube cleaning device comprises;

an elongate body, an expandable scaffold, a removal member and an actuation assembly;

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

wherein the removal member is coupled to the scaffold.

mechanically actuating the scaffold using said actuation assembly to expand said scaffold from the collapsed position to an expanded position, thereby expanding the removal member to contact the biofilm.

withdrawing the endotracheal tube cleaning device from said endotracheal tube while maintaining contact between the removal member and the biofilm to dislodge said biofilm, thereby collecting said dislodged biofilm within a portion of said endotracheal tube cleaning device; and

removing said endotracheal cleaning device from the patient.

62. The method of claim 54, further comprising:

inserting a distal airway cleaning device through the endotracheal tube, wherein the distal airway cleaning device comprises a steerable suction catheter having at least one suction lumen defined therein and a distal end configured to facilitate steering of the suction catheter within the airways of the patient; and

wherein the airway cleaning device comprises a visualization channel having a transparent window at its distal end and being configured to removably receive a visualization scope having imaging and light delivery elements,

inserting a visualization scope within the visualization channel;

advancing the distal airway cleaning device within a distal airway of the patient distal to the endotracheal tube;

positioning the distal end of the airway cleaning device within a target region of the distal airway;

inspecting the target region for accumulated debris using the visualization scope positioned within the visualization channel;

activating a suction force within the suction lumen of the suction catheter to remove accumulated debris from the distal airway; and

removing the distal airway cleaning device from the distal airway.

63. The method of claim 62, further comprising coupling a closed suction system adapter to the endotracheal tube.

64. The method of claim 63, wherein the step of inserting the distal airway cleaning device through the endotracheal tube comprises inserting the distal airway cleaning device through a port of the closed suction system adapter.

65. The method of claim 62, wherein the distal airway cleaning device comprises an endotracheal tube cleaning member.

66. The method of claim 65, wherein the endotracheal tube cleaning member comprises a mechanically expandable structure.

67. The method of claim 65, wherein the endotracheal tube cleaning member comprises a low-profile inflatable balloon.

68. The method of claim 61, wherein the expandable scaffold comprises a mesh scaffold and an outer sleeve positioned along at least a portion of an exterior surface of the expandable scaffold, and wherein at least a portion of the outer sleeve is configured to radially expand together with the expandable scaffold when the expandable scaffold moves from the collapsed position to the expanded position.

69. A method of providing visualized cleaning of endotracheal tubes and/or distal airways of a ventilated patient without disconnecting the patient from oxygen supply and without using a laryngoscope or bronchoscope, the method comprising:

inserting an endotracheal tube within a patient;

coupling an endotracheal tube adapter to the endotracheal tube, the endotracheal tube adapter having multiple inlet ports;

coupling an oxygen supply line to a first one of the multiple inlet ports;

inserting a visualization device through a second one of the multiple inlet ports;

confirming a position of the endotracheal tube within the patient using the visualization device;

inserting an endotracheal tube cleaning device through the second one of the multiple inlet ports;

wherein the endotracheal tube cleaning device comprises an elongate body, an expandable scaffold, a removal member and an actuation assembly;

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

wherein the removal member is coupled to the scaffold;

mechanically actuating the scaffold using said actuation assembly to expand said scaffold from the collapsed position to an expanded position, thereby expanding the removal member to contact the biofilm;

withdrawing the endotracheal tube cleaning device from said endotracheal tube while maintaining contact between the removal member and the biofilm to dislodge said biofilm, thereby collecting said dislodged biofilm within a portion of said endotracheal tube cleaning device; and

removing said endotracheal cleaning device from the patient.

70. The method of claim 69, further comprising:

inserting a distal airway cleaning device through one of the multiple inlet ports, wherein the distal airway cleaning device comprises a steerable suction catheter having at least one suction lumen defined therein and a distal end configured to facilitate steering of the suction catheter within the airways of the patient; and

wherein the airway cleaning device comprises a visualization channel having a transparent window at its distal end and being configured to removably receive a visualization scope having imaging and light delivery elements,

inserting a visualization scope within the visualization channel;

advancing the distal airway cleaning device within a distal airway of the patient distal to the endotracheal tube;

positioning the distal end of the airway cleaning device within a target region of the distal airway;

inspecting the target region for accumulated debris using the visualization scope positioned within the visualization channel;

activating a suction force within the suction lumen of the suction catheter to remove accumulated debris from the distal airway; and

removing the distal airway cleaning device from the distal airway.

71. The method of claim 69, further comprising coupling an adapter to the endotracheal tube that serves as a collection and sampling chamber for the biofilm, organized secretions or other debris that are removed from the endotracheal tube.

72. The method of claim 71, wherein the endotracheal tube adapter comprises a closed suction system adapter, and wherein the step of inserting the distal airway cleaning device through one of the multiple inlet ports comprises inserting the distal airway cleaning device within a closed suction system.

73. The method of claim 70, further comprising displaying images captured by the visualization scope on a display.

74. The method of claim 69, further comprising providing oxygen to the patient through an oxygen port of the endotracheal tube adapter such that oxygen flow is uninterrupted.

75. The method of claim 70, wherein the visualization scope comprises a fiber optic scope having imaging fibers and light fibers, and wherein the distal ends of the light fibers are positioned proximate to the distal ends of imaging fibers at an offset distance to reduce glare.

76. The method of claim 69, wherein the expandable scaffold comprises a mesh scaffold and an outer sleeve positioned along at least a portion of an exterior surface of the expandable scaffold, and wherein at least a portion of the outer sleeve is configured to radially expand together with the expandable scaffold when the expandable scaffold moves from the collapsed position to the expanded position.

77. The method of claim 69, wherein the visualization device comprises a visualization tube having an outer diameter of less than 2 mm, wherein the visualization device comprises a window formed of clear polycarbonate material at a distal end of the visualization device and wherein a thickness of the window is less than 0.012 inches, wherein the visualization device comprises at least one centering assembly mounted on an outer surface of the visualization device to center the visualization device within the endotracheal tube, and/or wherein the visualization device is disposable.