WO2019147574A1 - Cuff pressure control system and method for a tracheal tube - Google Patents

Cuff pressure control system and method for a tracheal tube Download PDF

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Publication number
WO2019147574A1
WO2019147574A1 PCT/US2019/014562 US2019014562W WO2019147574A1 WO 2019147574 A1 WO2019147574 A1 WO 2019147574A1 US 2019014562 W US2019014562 W US 2019014562W WO 2019147574 A1 WO2019147574 A1 WO 2019147574A1
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WO
WIPO (PCT)
Prior art keywords
cuff
pressure
fluid
tracheal tube
valve
Prior art date
Application number
PCT/US2019/014562
Other languages
French (fr)
Inventor
Dart A. FOX
Eric D. Blom
Brian Kamradt
Original Assignee
Hansa Medical Products, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hansa Medical Products, Inc. filed Critical Hansa Medical Products, Inc.
Publication of WO2019147574A1 publication Critical patent/WO2019147574A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/044External cuff pressure control or supply, e.g. synchronisation with respiration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0465Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/201Controlled valves
    • A61M16/202Controlled valves electrically actuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/208Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073Syringe, piston type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3379Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3386Low level detectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code

Definitions

  • the present disclosure relates generally to tracheal tubes and, more particularly, to tracheal tubes including pressure cuffs or balloons.
  • a tracheal tube is typically a catheter that is inserted into the trachea for the purpose of providing an airway for a patient.
  • a tracheostomy tube is one type of tracheal tube, which is inserted into a tracheostoma following a tracheostomy procedure.
  • An endotracheal tube is another type of tracheal tube that is inserted through the mouth (orotracheal) or nose (nasotracheal).
  • Another tracheal tube is a tracheal button, which may also be inserted into a puncture through the paratracheal skin into the trachea.
  • a tracheal tube may be cuffed or uncuffed.
  • Cuffed tracheal tubes include a cuff that can be expanded or inflated to minimize the passage of secretions from the upper respiratory tract downward into the lungs of a patient.
  • a cuff pressure control system utilizes a micro controller to display the current pressure in the cuff of a tracheal tube.
  • the cuff pressure control system has a display including two large, full-color seven segment screens.
  • the cuff pressure control system may be configured to change the digits of the display to yellow when the cuff pressure is below 20 cm H 2 O (centimeters of water), to green when the cuff pressure is between 20 and 30 cm H 2 O, and to red when the cuff pressure is at and above 31 cm H 2 O to permit a clinician to determine whether the cuff pressure is within an acceptable range at a glance at any given time.
  • the acceptable cuff pressure range may be between 20 and 30 cm H 2 O.
  • the cuff pressure control system may include a pressure canister in which a volume of pressurized air (several orders larger than the cuff balloon) is held.
  • the pressure canister may include a syringe with elastic bands or a spring.
  • the micro-controller may be configured to operate a valve to release a small portion of the pressurized air from the pressure canister into the cuff to bring the cuff pressure back to, for example, 20 cm H 2 O (i.e. , the center of the acceptable cuff pressure range in one embodiment).
  • the micro-controller may be configured to operate an additional valve to vent the over pressure to atmosphere.
  • the pressure canister may have a one-way valve that allows the clinician to pull the plunger back to draw additional air back into and re pressurize / recharge the canister once the volume of pressurized air has been used.
  • the pressure canister may have a magnetic switch at the tube end to alert the micro-controller and the clinician that the pressure canister is empty or nearly empty and requires recharging.
  • a tracheal tube system comprises a tracheal tube and a cuff pressure control system.
  • the tracheal tube includes a distal end sized to be positioned in a trachea of a patient and a cuff positioned adjacent to the distal end.
  • the cuff is configured to inflate to prevent fluid from flowing around the tracheal tube.
  • the cuff pressure control system is configured to be coupled to the cuff of the tracheal tube and includes a pressure canister configured to contain a quantity of pressurized fluid, a first valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff, a pressure sensor operable to sense pressure of fluid within the cuff, a display operable to provide a visual indication of fluid pressure within the cuff, and a controller.
  • the controller is configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is below a predefined threshold based on the signals from the pressure sensor, selectively operate the first valve to advance pressurized fluid from the pressure canister to the cuff, and operate the display to provide the visual indication of fluid pressure within the cuff.
  • the predefined threshold may be a first predefined threshold.
  • the cuff pressure control system may further comprise a second valve having an inlet coupled to the cuff and an outlet coupled to an exhaust vent.
  • the controller is configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the second valve to permit fluid to move from the cuff to the exhaust vent.
  • the second predefined threshold may be greater than 30 cm H 2 O. In some embodiments, the first predefined threshold may be less than 20 cm H 2 O.
  • the controller may be configured to de energize the first valve when the fluid pressure within the cuff is above the second predefined threshold.
  • the controller may be configured to de energize the second valve and energize the first valve when the fluid pressure within the cuff is below the predefined threshold.
  • the pressure canister may include a housing and a piston positioned in the housing.
  • the piston may be movable within the housing to maintain a constant fluid pressure in the pressure canister.
  • the piston may be moveable between a first position within the housing at which the pressure canister has a first fluid volume and a second position within the housing at which the pressure canister has a second fluid volume that is greater than the first fluid volume.
  • the pressure canister may include a biasing element operable to bias the piston in the first position.
  • the tracheal tube system may further comprise a position sensor that is configured to generate an output signal when the piston is located at the first position.
  • the controller may be operable to receive the output signal from the position sensor and energize an indicator to inform a user that the piston is located at the first position.
  • the indicator may be one of a visual indicator and an audible indicator.
  • the pressure canister may further include a handle coupled to the piston and sized to be grasped by the user to move the piston to the second position.
  • the tracheal tube system may further comprise an inlet valve coupled to the housing.
  • the inlet valve may be operable to open to permit fluid to enter the housing when the piston moves away from the first position toward the second position.
  • the first valve may include a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff and a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent.
  • the controller may be configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the first valve to permit fluid to move from the cuff to the exhaust vent.
  • the cuff pressure control system is configured to be coupled to a cuff of the tracheal tube and comprises a pressure canister configured to contain a quantity of pressurized fluid, a valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff, a pressure sensor operable to sense pressure of fluid within the cuff, a display operable to provide a visual indication of fluid pressure within the cuff, and a controller.
  • the controller configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is within a predefined pressure range based on the signals from the pressure sensor, selectively operate the valve to maintain fluid pressure in the cuff within the predefined pressure range, and operate the display to provide the visual indication of fluid pressure within the cuff.
  • the valve may include a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff and a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent.
  • the controller may be configured to selectively operate the valve to advance pressurized fluid from the pressure canister to the cuff when the fluid pressure in the cuff is below the predefined pressure range and selectively operate the valve to permit fluid to move from the cuff to the exhaust vent when the fluid pressure in the cuff is above the predefined pressure range.
  • the visual indication of fluid pressure within the cuff may be a first visual indication when the fluid pressure is within the predefined pressure range, a second visual indication when the fluid pressure is below the predefined pressure range, and a third visual indication when the fluid pressure is above the predefined pressure range.
  • the display may be operable to change a color of the visual indication based on fluid pressure within the cuff.
  • a method of controlling fluid pressure in a tracheal tube cuff includes measuring fluid pressure in the tracheal tube cuff, displaying the measured fluid pressure on a display, operating automatically a first valve to advance pressurized fluid from a pressure canister to the tracheal tube cuff in response to determining that the measured fluid pressure is below a first predefined threshold, and operating automatically a second valve to permit fluid to move from the tracheal tube cuff to an exhaust vent in response to determining that the measured fluid pressure is above a second predefined threshold.
  • the method may include adjusting automatically the configuration of the pressure canister to maintain a constant fluid pressure in the pressure canister.
  • the first predefined threshold may be less than 20 cm H 2 O. In some embodiments, the second predefined threshold may be greater than 30 cm H 2 O.
  • FIG. 1 is an exploded view of a tracheal tube system
  • FIG. 2 is a perspective view of the tracheal tube of FIG. 1 ;
  • FIG. 3 is a perspective view of the cuff pressure control system of
  • FIG. 1 is a diagrammatic representation of FIG. 1 ;
  • FIG. 4 is a cross-sectional view of a pressure canister of the cuff pressure control system of FIG. 1 ;
  • FIG. 5 is a simplified block diagram of components of the cuff pressure control system of FIG. 1 ;
  • FIG. 6 is a perspective view of a display of the cuff pressure control system of FIG. 1.
  • a tracheal tube system 10 includes a tracheal tube, which is illustratively a tracheostomy tube 12 , and a cuff pressure control system 50, which is configured to be coupled to the tracheostomy tube 12.
  • the tracheostomy tube 12 includes an outer cannula 14 for insertion through a tracheostoma of a patient and an inflatable cuff 16 attached to the outer cannula 14.
  • the cuff 16 is positioned to lie in the trachea of the patient below the patient’s glottis and is connected to the cuff pressure control system 50 via a conduit 18.
  • the cuff 16 is inflated with pressurized fluid (e.g. , pressurized air), and the cuff pressure control system 50 is configured to adjust automatically fluid pressure within the cuff 16.
  • the outer cannula 14 of the tracheostomy tube 12 includes a first port 26, which resides outside of the tracheostoma during use, and a second port 28 positioned at a distal end 30, which resides inside the trachea of the wearer below cuff 16 during use.
  • the cuff 16 is inflatable through the conduit 18 once the outer cannula 14 is in place in the trachea. When inflated, the cuff 16 engages the walls of the trachea to minimize the passage of fluid such as, for example, secretions or air from the upper respiratory tract downward into the lungs of the wearer.
  • the tracheostomy tube 12 is connected to the cuff pressure control system 50, which is configured to maintain fluid pressure in the cuff 16 within a predefined pressure range.
  • a controller 52 of the cuff pressure control system 50 is configured to selectively operate an inlet valve 54 and an exhaust valve 56 of the cuff pressure control system 50.
  • the controller 52 when the fluid pressure within the cuff 16 is below a predefined lower threshold, the controller 52 is configured to operate the inlet valve 54 to advance pressurized fluid from a pressure canister 40 to the cuff 16.
  • the controller 52 is configured to operate the exhaust valve 56 to permit pressurized fluid to move from the cuff 16 to atmosphere.
  • the cuff pressure control system 50 further includes a display 60 that is operable to provide a visual indication of fluid pressure with the cuff 16 and visual and audible indicators 62 , 64 to inform a user that the pressurized fluid contained in the pressure canister 40 is less than a predefined fluid volume.
  • the cuff pressure control system 50 may include only one of the visual and audible indicators 62, 64. In still other embodiments, the indicators may be omitted.
  • the cuff pressure control system 50 includes a housing mounted to the pressure canister 40.
  • the housing contains the controller 52 , and the visual and audible indicators 62, 64, which are electrically-connected to the controller 52, are mounted to the housing.
  • the display 60 is also mounted to the housing and is electrically- connected to the controller 52 such that the controller 52 operates the display 60 to provide a visual indication of fluid pressure within the cuff 16.
  • the display 60 is configured to change color based on fluid pressure within the cuff 16.
  • the controller 52 is configured to cause the display 60 to show the fluid pressure in green if the fluid pressure within the cuff 16 is within the predefined pressure range, in yellow if the fluid pressure is below a predefined lower threshold, and in red if the fluid pressure is below a predefined upper threshold.
  • the predefined pressure range is between 20 cm H 2 O and 30 cm H 2 O in the illustrative embodiment. As such, when the pressure is below 20 cm H 2 O, the display 60 shows the cuff pressure in yellow; when the pressure is above 30 cm H 2 O, the display 60 shows the cuff pressure in red.
  • the pressure canister 40 includes a housing 42, a piston 44 positioned in the housing 42, and an outlet 46.
  • the piston 44 is moveable within the housing 42 to maintain a constant fluid pressure in the pressure canister 40.
  • the piston 44 is moveable between a retracted position and an extended position within the housing 42. When the piston 44 is in the retracted position, the piston 44 is closer to the outlet 46 in the first position. In other words, the fluid volume contained in the pressure canister 40 decreases as the piston 44 moves from the extended position to the retracted position.
  • FIG. 4 illustrates the piston 44 at the retracted position.
  • the pressure canister 40 further includes a biasing element 45 that is operable to bias the piston 44 in the retracted position to assist in maintaining pressure in the housing 42.
  • the pressure canister 40 also includes a piston position sensor 47 configured to detect the position of the piston 44 within the housing 42.
  • the sensor 47 is a magnetic switch that is triggered when the piston 44 reaches the retracted position. In that way, the magnetic switch 47 registers the position of the piston 44 at the retracted position and transmits an output signal to the controller 52. It should be appreciated that in other embodiments optical sensor, magnetic sensors, and other position sensor types may be used in place of (or in addition to) the magnetic switch.
  • the controller 52 informs a user that the piston 44 is located at the retracted position. To do so, the controller 52 is configured to energize at least one of the visual and audible indicators 62, 64 to inform the user to replenish fluid of the pressure canister 40. It should be appreciated that in other embodiments the sensor 47 may be positioned between the retracted position and the extended position such that the user is informed that the canister requires a recharge while some amount of pressurized air remains.
  • the pressure canister 40 further includes an inlet valve 48 coupled to the housing 42.
  • the inlet valve 48 is operable to open to permit fluid to enter the housing 42 when the piston 44 moves away from the retracted position toward the extended position.
  • a user may grasp a handle 49 of the pressure canister that is coupled to the piston 44 to draw the piston 44 away from the outlet 46.
  • the inlet valve 48 is opened inwardly toward the housing 42 to allow fluid outside of the pressure canister 40 to enter the housing 42 of the pressure canister 40.
  • a spring in the valve 48 urges the valve 48 to close.
  • the cuff pressure control system 50 also includes a pressure sensor 58 configured to sense the fluid pressure within the pressure canister 40.
  • the pressure sensor 58 is a pressure transducer that is electrically connected to the controller 52.
  • the controller 52 is configured to receive output signals from the pressure transducer 58, which indicate measured fluid pressure within the cuff 16.
  • the pressure sensor may be embodied as any type of sensor capable of sensing an amount of pressure applied to the cuff 16.
  • the controller 52 is further configured to output the measured fluid pressure on the display 60 based on signals from the pressure transducer 68, as described above.
  • the inlet and exhaust valves 54, 56 are electrically coupled to the controller 52.
  • each valve is initially de-energized and closed to prevent the movement of fluid between the canister 40, cuff 16, and atmosphere.
  • the inlet valve 54 includes an inlet 72 coupled an inlet port 74 of the manifold via a conduit 76.
  • the inlet port 74 is coupled to the outlet 46 of the pressure canister 40.
  • the inlet port 74 of the manifold may be embodied as the outlet 46 of the pressure canister 40.
  • the inlet 72 of the inlet valve 54 may be directly coupled to the inlet port 74 of the manifold without the conduit 76.
  • the inlet valve 54 further includes an outlet 78 coupled to an outlet port 80 of the manifold via a conduit 82.
  • the outlet port 80 is coupled to the cuff 16 to allow pressurized fluid from the pressure canister 40 to flow into the cuff 16 when the inlet valve 54 is energized.
  • the inlet of the pressure sensor 58 is also connected to the conduit 82.
  • the exhaust valve 56 includes an inlet 84 coupled to the outlet port 80 of the manifold via a conduit 86 and an outlet 88 coupled to an exhaust vent port 70 of the manifold via a conduit 90. This permits fluid to flow from the cuff 16 to the exhaust vent port 70 when the exhaust valve 56 is energized.
  • the outlet 88 of the exhaust valve 56 may be directly coupled to the exhaust vent port 70 without the conduit 90.
  • the inlet valve 54 is initially de-energized and the cuff 16 is deflated.
  • the pressure transducer 68 senses the fluid pressure within the cuff 16 and transmits signals to the controller 52.
  • the controller 52 displays the fluid pressure on the display 60 and determines whether the fluid pressure is within a predefined pressure range. If the controller 52 determines that the fluid pressure is below a predefined lower threshold (e.g., 20 cm H 2 O), the controller 52 energizes the inlet valve 54 to permit the fluid from the pressure canister 40 to advance to the cuff 16 until the fluid pressure is greater than predefined lower threshold or reaches a predefined target value such as, for example, 25 cm H 2 O.
  • a predefined lower threshold e.g. 20 cm H 2 O
  • the controller 52 de-energizes the inlet valve 54 to stop the fluid flow.
  • the controller 52 continues to monitor the fluid pressure within the cuff 16 based on signals from the pressure transducer 68. At any time, if the controller 52 determines that the measured fluid pressure within the cuff 16 is above a predefined upper threshold (e.g. , 30 cm H 2 O) , the controller 52 energizes the exhaust valve 56 to allow fluid to be exhausted from the cuff 16 out to the exhaust vent port 70.
  • a predefined upper threshold e.g. , 30 cm H 2 O
  • the controller 52 energizes the exhaust valve 56 to allow fluid to be exhausted from the cuff 16 out to the exhaust vent port 70.
  • the predefined lower threshold may be any pressure less than 20 cm H 2 O
  • the predefined upper threshold may be any pressure greater than 30 cm H 2 O.
  • the controller 52 is also electrically connected to the magnetic switch 47 of the pressure canister 40.
  • the pressure canister 40 contains a fixed quantity or volume of pressurized fluid. In use, the volume of the pressurized fluid in the pressure canister 40 decreases as the fluid advances to the cuff 16 to maintain fluid pressure in the cuff 16 within the predefined pressure range.
  • the magnetic switch 47 is configured to transmit signals to the controller 52 to indicate that the pressure canister 40 needs to be filled.
  • the controller 52 energizes at least one of the visual and audible indicators 62, 64 to inform a user of status of the pressure canister 40.
  • the visual indicator is embodied as a LED 62 and the audible indicator is embodied as a speaker 64.
  • the display 60 is embodied as a pair of full-color seven-segment display (SSD) screens.
  • the display 60 may be embodied as any type of display capable of displaying digital information such as a liquid crystal display (LCD), a light emitting diode (LED) , a plasma display, a cathode ray tube (CRT), or other type of display device.
  • LCD liquid crystal display
  • LED light emitting diode
  • CRT cathode ray tube
  • the inlet valve 54 and the exhaust valve 56 may be combined into a single valve, such as, for example, a three-way valve.
  • the single valve may include a first chamber positioned between an inlet coupled to the pressure canister 40 and an outlet coupled to the cuff 16 and a second chamber positioned between a second inlet coupled to the cuff 16 and a second outlet coupled to an exhaust vent port 70.
  • the controller 52 may be configured to selectively operate the single valve to permit fluid to move from the cuff 16 to the exhaust vent port 70 based on the fluid pressure within the cuff 16.
  • the controller 52 may energize the single valve to open the first chamber to advance pressurized fluid from the pressure canister 40 to the cuff 16 if the fluid pressure within the cuff 16 is below the predefined lower threshold.
  • the controller 52 may energize the single valve to open the second chamber to release pressurized fluid from the cuff 16 to the exhaust vent port 70 if the fluid pressure within the cuff 16 is above the predefined upper threshold.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

A system and method for controlling pressure within a cuff of a tracheal tube are disclosed.

Description

CUFF PRESSURE CONTROL SYSTEM
AND METHOD FOR A TRACHEAL TUBE
CROSS-REFERENCE TO RELATED APPLICATIONS
[OOOl] This application claims priority to U.S Provisional Application No. 62/620,640, filed January 23, 2018, the entire disclosure of which is expressly incorporated by reference herein.
TECHNICAL FIELD
[0002] The present disclosure relates generally to tracheal tubes and, more particularly, to tracheal tubes including pressure cuffs or balloons.
BACKGROUND
[0003] A tracheal tube is typically a catheter that is inserted into the trachea for the purpose of providing an airway for a patient. A tracheostomy tube is one type of tracheal tube, which is inserted into a tracheostoma following a tracheostomy procedure. An endotracheal tube is another type of tracheal tube that is inserted through the mouth (orotracheal) or nose (nasotracheal). Another tracheal tube is a tracheal button, which may also be inserted into a puncture through the paratracheal skin into the trachea.
[0004] A tracheal tube may be cuffed or uncuffed. Cuffed tracheal tubes include a cuff that can be expanded or inflated to minimize the passage of secretions from the upper respiratory tract downward into the lungs of a patient.
SUMMARY
[0005] According to one aspect of the disclosure, a cuff pressure control system is disclosed. The cuff pressure control system utilizes a micro controller to display the current pressure in the cuff of a tracheal tube. The cuff pressure control system has a display including two large, full-color seven segment screens. In some embodiments, the cuff pressure control system may be configured to change the digits of the display to yellow when the cuff pressure is below 20 cm H2O (centimeters of water), to green when the cuff pressure is between 20 and 30 cm H2O, and to red when the cuff pressure is at and above 31 cm H2O to permit a clinician to determine whether the cuff pressure is within an acceptable range at a glance at any given time. In some embodiments, the acceptable cuff pressure range may be between 20 and 30 cm H2O.
[0006] In some embodiments, the cuff pressure control system may include a pressure canister in which a volume of pressurized air (several orders larger than the cuff balloon) is held. In some embodiments, the pressure canister may include a syringe with elastic bands or a spring. When the cuff pressure falls below 20 cm H2O, the micro-controller may be configured to operate a valve to release a small portion of the pressurized air from the pressure canister into the cuff to bring the cuff pressure back to, for example, 20 cm H2O (i.e. , the center of the acceptable cuff pressure range in one embodiment). If the pressure in the cuff rises over the limit of, for example, 30 cm H2O, the micro-controller may be configured to operate an additional valve to vent the over pressure to atmosphere. In some embodiments, the pressure canister may have a one-way valve that allows the clinician to pull the plunger back to draw additional air back into and re pressurize / recharge the canister once the volume of pressurized air has been used. In some embodiments, the pressure canister may have a magnetic switch at the tube end to alert the micro-controller and the clinician that the pressure canister is empty or nearly empty and requires recharging.
[0007] According to another aspect of the disclosure, a tracheal tube system is disclosed. The tracheal tube system comprises a tracheal tube and a cuff pressure control system. The tracheal tube includes a distal end sized to be positioned in a trachea of a patient and a cuff positioned adjacent to the distal end. The cuff is configured to inflate to prevent fluid from flowing around the tracheal tube. The cuff pressure control system is configured to be coupled to the cuff of the tracheal tube and includes a pressure canister configured to contain a quantity of pressurized fluid, a first valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff, a pressure sensor operable to sense pressure of fluid within the cuff, a display operable to provide a visual indication of fluid pressure within the cuff, and a controller. The controller is configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is below a predefined threshold based on the signals from the pressure sensor, selectively operate the first valve to advance pressurized fluid from the pressure canister to the cuff, and operate the display to provide the visual indication of fluid pressure within the cuff.
[0008] In some embodiments, the predefined threshold may be a first predefined threshold. The cuff pressure control system may further comprise a second valve having an inlet coupled to the cuff and an outlet coupled to an exhaust vent. In such embodiments, the controller is configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the second valve to permit fluid to move from the cuff to the exhaust vent.
[0009] In some embodiments, the second predefined threshold may be greater than 30 cm H2O. In some embodiments, the first predefined threshold may be less than 20 cm H2O.
[0010] In some embodiments, the controller may be configured to de energize the first valve when the fluid pressure within the cuff is above the second predefined threshold.
[0011] In some embodiments, the controller may be configured to de energize the second valve and energize the first valve when the fluid pressure within the cuff is below the predefined threshold.
[0012] In some embodiments, the pressure canister may include a housing and a piston positioned in the housing. The piston may be movable within the housing to maintain a constant fluid pressure in the pressure canister.
[0013] In some embodiments, the piston may be moveable between a first position within the housing at which the pressure canister has a first fluid volume and a second position within the housing at which the pressure canister has a second fluid volume that is greater than the first fluid volume.
[0014] In some embodiments, the pressure canister may include a biasing element operable to bias the piston in the first position.
[0015] In some embodiments, the tracheal tube system may further comprise a position sensor that is configured to generate an output signal when the piston is located at the first position. In such embodiments, the controller may be operable to receive the output signal from the position sensor and energize an indicator to inform a user that the piston is located at the first position.
[0016] In some embodiments, the indicator may be one of a visual indicator and an audible indicator.
[0017] In some embodiments, the pressure canister may further include a handle coupled to the piston and sized to be grasped by the user to move the piston to the second position.
[0018] In some embodiments, the tracheal tube system may further comprise an inlet valve coupled to the housing. In such embodiments, the inlet valve may be operable to open to permit fluid to enter the housing when the piston moves away from the first position toward the second position.
[0019] In some embodiments, the first valve may include a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff and a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent. In such embodiments, the controller may be configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the first valve to permit fluid to move from the cuff to the exhaust vent.
[0020] According to another aspect, the cuff pressure control system is configured to be coupled to a cuff of the tracheal tube and comprises a pressure canister configured to contain a quantity of pressurized fluid, a valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff, a pressure sensor operable to sense pressure of fluid within the cuff, a display operable to provide a visual indication of fluid pressure within the cuff, and a controller. The controller configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is within a predefined pressure range based on the signals from the pressure sensor, selectively operate the valve to maintain fluid pressure in the cuff within the predefined pressure range, and operate the display to provide the visual indication of fluid pressure within the cuff.
[0021] In some embodiments, the valve may include a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff and a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent. In such embodiments, the controller may be configured to selectively operate the valve to advance pressurized fluid from the pressure canister to the cuff when the fluid pressure in the cuff is below the predefined pressure range and selectively operate the valve to permit fluid to move from the cuff to the exhaust vent when the fluid pressure in the cuff is above the predefined pressure range.
[0022] In some embodiments, the visual indication of fluid pressure within the cuff may be a first visual indication when the fluid pressure is within the predefined pressure range, a second visual indication when the fluid pressure is below the predefined pressure range, and a third visual indication when the fluid pressure is above the predefined pressure range.
[0023] In some embodiments, the display may be operable to change a color of the visual indication based on fluid pressure within the cuff.
[0024] According to another aspect, a method of controlling fluid pressure in a tracheal tube cuff is disclosed. The method includes measuring fluid pressure in the tracheal tube cuff, displaying the measured fluid pressure on a display, operating automatically a first valve to advance pressurized fluid from a pressure canister to the tracheal tube cuff in response to determining that the measured fluid pressure is below a first predefined threshold, and operating automatically a second valve to permit fluid to move from the tracheal tube cuff to an exhaust vent in response to determining that the measured fluid pressure is above a second predefined threshold.
[0025] In some embodiments, the method may include adjusting automatically the configuration of the pressure canister to maintain a constant fluid pressure in the pressure canister.
[0026] In some embodiments, the first predefined threshold may be less than 20 cm H2O. In some embodiments, the second predefined threshold may be greater than 30 cm H2O.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The detailed description particularly refers to the following figures, in which: [0028] FIG. 1 is an exploded view of a tracheal tube system;
[0029] FIG. 2 is a perspective view of the tracheal tube of FIG. 1 ;
[0030] FIG. 3 is a perspective view of the cuff pressure control system of
FIG. 1 ;
[0031] FIG. 4 is a cross-sectional view of a pressure canister of the cuff pressure control system of FIG. 1 ;
[0032] FIG. 5 is a simplified block diagram of components of the cuff pressure control system of FIG. 1 ; and
[0033] FIG. 6 is a perspective view of a display of the cuff pressure control system of FIG. 1.
DETAILED DESCRIPTION OF THE DRAWINGS
[0034] While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
[0035] Referring now to FIG. 1 , a tracheal tube system 10 includes a tracheal tube, which is illustratively a tracheostomy tube 12 , and a cuff pressure control system 50, which is configured to be coupled to the tracheostomy tube 12. The tracheostomy tube 12 includes an outer cannula 14 for insertion through a tracheostoma of a patient and an inflatable cuff 16 attached to the outer cannula 14. The cuff 16 is positioned to lie in the trachea of the patient below the patient’s glottis and is connected to the cuff pressure control system 50 via a conduit 18. As described in greater detail below, the cuff 16 is inflated with pressurized fluid (e.g. , pressurized air), and the cuff pressure control system 50 is configured to adjust automatically fluid pressure within the cuff 16.
[0036] Referring now to FIG. 2, the outer cannula 14 of the tracheostomy tube 12 includes a first port 26, which resides outside of the tracheostoma during use, and a second port 28 positioned at a distal end 30, which resides inside the trachea of the wearer below cuff 16 during use. The cuff 16 is inflatable through the conduit 18 once the outer cannula 14 is in place in the trachea. When inflated, the cuff 16 engages the walls of the trachea to minimize the passage of fluid such as, for example, secretions or air from the upper respiratory tract downward into the lungs of the wearer. The construction of the cuff 16 as a sleeve 32 with its upper and lower ends 34, 36, respectively, tucked under, rather than extending beyond the cuff 16 up and down the outer sidewall of the outer cannula 14, is aided by the use of thin-walled material for the cuff 16.
[0037] Returning to FIG. 1 , the tracheostomy tube 12 is connected to the cuff pressure control system 50, which is configured to maintain fluid pressure in the cuff 16 within a predefined pressure range. To do so, a controller 52 of the cuff pressure control system 50 is configured to selectively operate an inlet valve 54 and an exhaust valve 56 of the cuff pressure control system 50. For example, when the fluid pressure within the cuff 16 is below a predefined lower threshold, the controller 52 is configured to operate the inlet valve 54 to advance pressurized fluid from a pressure canister 40 to the cuff 16. On the other hand, when the fluid pressure within the cuff 16 exceeds a predefined upper threshold, the controller 52 is configured to operate the exhaust valve 56 to permit pressurized fluid to move from the cuff 16 to atmosphere.
[0038] Additionally, as shown in FIG. 1 , the cuff pressure control system 50 further includes a display 60 that is operable to provide a visual indication of fluid pressure with the cuff 16 and visual and audible indicators 62 , 64 to inform a user that the pressurized fluid contained in the pressure canister 40 is less than a predefined fluid volume. It should be appreciate that, in some embodiments, the cuff pressure control system 50 may include only one of the visual and audible indicators 62, 64. In still other embodiments, the indicators may be omitted.
[0039] Referring now to FIG. 3, the cuff pressure control system 50 includes a housing mounted to the pressure canister 40. The housing contains the controller 52 , and the visual and audible indicators 62, 64, which are electrically-connected to the controller 52, are mounted to the housing. The display 60 is also mounted to the housing and is electrically- connected to the controller 52 such that the controller 52 operates the display 60 to provide a visual indication of fluid pressure within the cuff 16.
[0040] In the illustrative embodiment, the display 60 is configured to change color based on fluid pressure within the cuff 16. The controller 52 is configured to cause the display 60 to show the fluid pressure in green if the fluid pressure within the cuff 16 is within the predefined pressure range, in yellow if the fluid pressure is below a predefined lower threshold, and in red if the fluid pressure is below a predefined upper threshold. The predefined pressure range is between 20 cm H2O and 30 cm H2O in the illustrative embodiment. As such, when the pressure is below 20 cm H2O, the display 60 shows the cuff pressure in yellow; when the pressure is above 30 cm H2O, the display 60 shows the cuff pressure in red.
[0041] Referring now to FIG. 4, the pressure canister 40 includes a housing 42, a piston 44 positioned in the housing 42, and an outlet 46. The piston 44 is moveable within the housing 42 to maintain a constant fluid pressure in the pressure canister 40. The piston 44 is moveable between a retracted position and an extended position within the housing 42. When the piston 44 is in the retracted position, the piston 44 is closer to the outlet 46 in the first position. In other words, the fluid volume contained in the pressure canister 40 decreases as the piston 44 moves from the extended position to the retracted position. FIG. 4 illustrates the piston 44 at the retracted position.
[0042] In the illustrative embodiment, the pressure canister 40 further includes a biasing element 45 that is operable to bias the piston 44 in the retracted position to assist in maintaining pressure in the housing 42. The pressure canister 40 also includes a piston position sensor 47 configured to detect the position of the piston 44 within the housing 42. In the illustrative embodiment, the sensor 47 is a magnetic switch that is triggered when the piston 44 reaches the retracted position. In that way, the magnetic switch 47 registers the position of the piston 44 at the retracted position and transmits an output signal to the controller 52. It should be appreciated that in other embodiments optical sensor, magnetic sensors, and other position sensor types may be used in place of (or in addition to) the magnetic switch. [0043] In response, the controller 52 informs a user that the piston 44 is located at the retracted position. To do so, the controller 52 is configured to energize at least one of the visual and audible indicators 62, 64 to inform the user to replenish fluid of the pressure canister 40. It should be appreciated that in other embodiments the sensor 47 may be positioned between the retracted position and the extended position such that the user is informed that the canister requires a recharge while some amount of pressurized air remains.
[0044] The pressure canister 40 further includes an inlet valve 48 coupled to the housing 42. The inlet valve 48 is operable to open to permit fluid to enter the housing 42 when the piston 44 moves away from the retracted position toward the extended position. For example, a user may grasp a handle 49 of the pressure canister that is coupled to the piston 44 to draw the piston 44 away from the outlet 46. While the user draws the piston 44 to the second position, the inlet valve 48 is opened inwardly toward the housing 42 to allow fluid outside of the pressure canister 40 to enter the housing 42 of the pressure canister 40. When the user positions the piston 44 at the extended position, a spring in the valve 48 urges the valve 48 to close.
[0045] Referring now to FIG. 5, the inlet valve 54 and the exhaust valve 56 are positioned in a manifold attached to the end of the pressure canister 40. The cuff pressure control system 50 also includes a pressure sensor 58 configured to sense the fluid pressure within the pressure canister 40. In the illustrative embodiment, the pressure sensor 58 is a pressure transducer that is electrically connected to the controller 52. The controller 52 is configured to receive output signals from the pressure transducer 58, which indicate measured fluid pressure within the cuff 16. It should be appreciated that the pressure sensor may be embodied as any type of sensor capable of sensing an amount of pressure applied to the cuff 16. The controller 52 is further configured to output the measured fluid pressure on the display 60 based on signals from the pressure transducer 68, as described above.
[0046] As described above, the inlet and exhaust valves 54, 56 are electrically coupled to the controller 52. In the illustrative embodiment, each valve is initially de-energized and closed to prevent the movement of fluid between the canister 40, cuff 16, and atmosphere. As shown in FIG. 5, the inlet valve 54 includes an inlet 72 coupled an inlet port 74 of the manifold via a conduit 76. The inlet port 74 is coupled to the outlet 46 of the pressure canister 40. In some embodiments, the inlet port 74 of the manifold may be embodied as the outlet 46 of the pressure canister 40. In other embodiments, the inlet 72 of the inlet valve 54 may be directly coupled to the inlet port 74 of the manifold without the conduit 76. The inlet valve 54 further includes an outlet 78 coupled to an outlet port 80 of the manifold via a conduit 82. The outlet port 80 is coupled to the cuff 16 to allow pressurized fluid from the pressure canister 40 to flow into the cuff 16 when the inlet valve 54 is energized. As shown in FIG. 5, the inlet of the pressure sensor 58 is also connected to the conduit 82.
[0047] The exhaust valve 56 includes an inlet 84 coupled to the outlet port 80 of the manifold via a conduit 86 and an outlet 88 coupled to an exhaust vent port 70 of the manifold via a conduit 90. This permits fluid to flow from the cuff 16 to the exhaust vent port 70 when the exhaust valve 56 is energized. In some embodiments, the outlet 88 of the exhaust valve 56 may be directly coupled to the exhaust vent port 70 without the conduit 90.
[0048] In use, the inlet valve 54 is initially de-energized and the cuff 16 is deflated. The pressure transducer 68 senses the fluid pressure within the cuff 16 and transmits signals to the controller 52. In response, the controller 52 displays the fluid pressure on the display 60 and determines whether the fluid pressure is within a predefined pressure range. If the controller 52 determines that the fluid pressure is below a predefined lower threshold (e.g., 20 cm H2O), the controller 52 energizes the inlet valve 54 to permit the fluid from the pressure canister 40 to advance to the cuff 16 until the fluid pressure is greater than predefined lower threshold or reaches a predefined target value such as, for example, 25 cm H2O. When the fluid pressure reaches the desired pressure, the controller 52 de-energizes the inlet valve 54 to stop the fluid flow. The controller 52 continues to monitor the fluid pressure within the cuff 16 based on signals from the pressure transducer 68. At any time, if the controller 52 determines that the measured fluid pressure within the cuff 16 is above a predefined upper threshold (e.g. , 30 cm H2O) , the controller 52 energizes the exhaust valve 56 to allow fluid to be exhausted from the cuff 16 out to the exhaust vent port 70. It should be appreciated that the predefined lower threshold may be any pressure less than 20 cm H2O, and the predefined upper threshold may be any pressure greater than 30 cm H2O.
[0049] The controller 52 is also electrically connected to the magnetic switch 47 of the pressure canister 40. As described above, the pressure canister 40 contains a fixed quantity or volume of pressurized fluid. In use, the volume of the pressurized fluid in the pressure canister 40 decreases as the fluid advances to the cuff 16 to maintain fluid pressure in the cuff 16 within the predefined pressure range. As such, the magnetic switch 47 is configured to transmit signals to the controller 52 to indicate that the pressure canister 40 needs to be filled. In response, the controller 52 energizes at least one of the visual and audible indicators 62, 64 to inform a user of status of the pressure canister 40. In the illustrative embodiment, the visual indicator is embodied as a LED 62 and the audible indicator is embodied as a speaker 64.
[0050] Referring now to FIG. 6, in the illustrative embodiment, the display 60 is embodied as a pair of full-color seven-segment display (SSD) screens. However, in some embodiments, the display 60 may be embodied as any type of display capable of displaying digital information such as a liquid crystal display (LCD), a light emitting diode (LED) , a plasma display, a cathode ray tube (CRT), or other type of display device.
[0051] It should be appreciated that, in some embodiments, the inlet valve 54 and the exhaust valve 56 may be combined into a single valve, such as, for example, a three-way valve. The single valve may include a first chamber positioned between an inlet coupled to the pressure canister 40 and an outlet coupled to the cuff 16 and a second chamber positioned between a second inlet coupled to the cuff 16 and a second outlet coupled to an exhaust vent port 70. In such embodiments, the controller 52 may be configured to selectively operate the single valve to permit fluid to move from the cuff 16 to the exhaust vent port 70 based on the fluid pressure within the cuff 16. For example, the controller 52 may energize the single valve to open the first chamber to advance pressurized fluid from the pressure canister 40 to the cuff 16 if the fluid pressure within the cuff 16 is below the predefined lower threshold. On the other hand, the controller 52 may energize the single valve to open the second chamber to release pressurized fluid from the cuff 16 to the exhaust vent port 70 if the fluid pressure within the cuff 16 is above the predefined upper threshold.
[0052] There are a plurality of advantages of the present disclosure arising from the various features of the method, apparatus, and system described herein. It will be noted that alternative embodiments of the method, apparatus, and system of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the method, apparatus, and system that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A tracheal tube system, comprising:
a tracheal tube including a distal end sized to be positioned in a trachea of a patient and a cuff positioned adjacent to the distal end, the cuff being configured to inflate to prevent fluid from flowing around the tracheal tube, and
a cuff pressure control system configured to be coupled to the cuff of the tracheal tube, the cuff pressure control system comprising:
(i) a pressure canister configured to contain a quantity of pressurized fluid,
(ii) a first valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff,
(iii) a pressure sensor operable to sense pressure of fluid within the cuff,
(iv) a display operable to provide a visual indication of fluid pressure within the cuff, and
(v) a controller configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is below a predefined threshold based on the signals from the pressure sensor, selectively operate the first valve to advance pressurized fluid from the pressure canister to the cuff, and operate the display to provide the visual indication of fluid pressure within the cuff.
2. The tracheal tube system of claim 1 , wherein: the predefined threshold is a first predefined threshold, the cuff pressure control system further comprises a second valve having an inlet coupled to the cuff and an outlet coupled to an exhaust vent, and
the controller is configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the second valve to permit fluid to move from the cuff to the exhaust vent.
3. The tracheal tube system of claim 2, wherein the second predefined threshold is greater than 30 cm H2O.
4. The tracheal tube system of claim 3, wherein the first predefined threshold is less than 20 cm H2O.
5. The tracheal tube system of claim 2 , wherein the controller is configured to de-energize the first valve when the fluid pressure within the cuff is above the second predefined threshold.
6. The tracheal tube system of claim 4, wherein the controller is configured to de-energize the second valve and energize the first valve when the fluid pressure within the cuff is below the predefined threshold.
7. The tracheal tube system of claim 1 , wherein the pressure canister includes a housing and a piston positioned in the housing, the piston being movable within the housing to maintain a constant fluid pressure in the pressure canister.
8. The tracheal tube system of claim 7, wherein the piston is moveable between a first position within the housing at which the pressure canister has a first fluid volume and a second position within the housing at which the pressure canister has a second fluid volume that is greater than the first fluid volume.
9. The tracheal tube system of claim 8, wherein the pressure canister includes a biasing element operable to bias the piston in the first position.
10. The tracheal tube system of claim 8, further comprising: a position sensor configured to generate an output signal when the piston is located at the first position, and
the controller is operable to receive the output signal from the position sensor and energize an indicator to inform a user that the piston is located at the first position.
1 1. The tracheal tube system of claim 10, wherein the indicator is one of a visual indicator and an audible indicator.
12. The tracheal tube system of claim 10, wherein the pressure canister further includes a handle coupled to the piston and sized to be grasped by the user to move the piston to the second position.
13. The tracheal tube system of claim 8, further comprising an inlet valve coupled to the housing, the inlet valve being operable to open to permit fluid to enter the housing when the piston moves away from the first position toward the second position.
14. The tracheal tube system of claim 1 , wherein the first valve includes:
a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff,
a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent, and
the controller is configured to determine whether the fluid pressure within the cuff is above a second predefined threshold based on the signals from the pressure sensor, and selectively operate the first valve to permit fluid to move from the cuff to the exhaust vent.
15. A cuff pressure control system configured to be coupled to a cuff of the tracheal tube, the cuff pressure control system comprising:
a pressure canister configured to contain a quantity of pressurized fluid,
a valve having an inlet coupled to the pressure canister and an outlet configured to be coupled to the cuff,
a pressure sensor operable to sense pressure of fluid within the cuff,
a display operable to provide a visual indication of fluid pressure within the cuff, and
a controller configured to receive signals from the pressure sensor, determine whether the fluid pressure within the cuff is within a predefined pressure range based on the signals from the pressure sensor, selectively operate the valve to maintain fluid pressure in the cuff within the predefined pressure range, and operate the display to provide the visual indication of fluid pressure within the cuff.
16. The cuff pressure control system of claim 15, wherein the valve includes:
a first chamber positioned between the inlet coupled to the pressure canister and the outlet coupled to the cuff,
a second chamber positioned between a second inlet coupled to the cuff and a second outlet coupled to an exhaust vent, and
the controller is configured to selectively operate the valve to advance pressurized fluid from the pressure canister to the cuff when the fluid pressure in the cuff is below the predefined pressure range and selectively operate the valve to permit fluid to move from the cuff to the exhaust vent when the fluid pressure in the cuff is above the predefined pressure range.
17. The cuff pressure control system of claim 15, wherein the visual indication of fluid pressure within the cuff is a first visual indication when the fluid pressure is within the predefined pressure range, a second visual indication when the fluid pressure is below the predefined pressure range, and a third visual indication when the fluid pressure is above the predefined pressure range.
18. The cuff pressure control system of claim 15, wherein the display is operable to change a color of the visual indication based on fluid pressure within the cuff.
19. A method of controlling fluid pressure in a tracheal tube cuff, the method comprising:
measuring fluid pressure in the tracheal tube cuff,
displaying the measured fluid pressure on a display, operating automatically a first valve to advance pressurized fluid from a pressure canister to the tracheal tube cuff in response to determining that the measured fluid pressure is below a first predefined threshold, and operating automatically a second valve to permit fluid to move from the tracheal tube cuff to an exhaust vent in response to determining that the measured fluid pressure is above a second predefined threshold.
20. The method of claim 19, further comprising adjusting automatically the configuration of the pressure canister to maintain a constant fluid pressure in the pressure canister.
21. The method of claim 19, wherein the first predefined threshold is less than 20 cm H2O.
22. The tracheal tube system of claim 19, wherein the second predefined threshold is greater than 30 cm H2O.
PCT/US2019/014562 2018-01-23 2019-01-22 Cuff pressure control system and method for a tracheal tube WO2019147574A1 (en)

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