Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M16/0006—Accessories therefor, e.g. sensors, vibrators, negative pressure with means for creating vibrations in patients' airways
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0057—Pumps therefor
  • A61M16/0066—Blowers or centrifugal pumps
  • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M16/0009—Accessories therefor, e.g. sensors, vibrators, negative pressure with sub-atmospheric pressure, e.g. during expiration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
  • A61M16/022—Control means therefor
  • A61M16/024—Control means therefor including calculation means, e.g. using a processor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
  • A61M16/0666—Nasal cannulas or tubing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/20—Valves specially adapted to medical respiratory devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Measuring devices for evaluating the respiratory organs
  • A61B5/087—Measuring breath flow
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
  • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3334—Measuring or controlling the flow rate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3365—Rotational speed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
  • A61M2205/502—User interfaces, e.g. screens or keyboards
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities

Definitions

• the present disclosure pertains to a method and system configured to in- exsufflate a subject by controlling the in-exsuffiation pressure waveform provided to the subject.
• one or more aspects of the present disclosure relate to a system configured to in-exsufflate a subject.
• the system comprises a pressure generator, a subject interface, one or more sensors, and one or more processors.
• the pressure generator is configured to generate a flow of breathable gas for delivery to an airway of the subject according to an in-exsufflation therapy regime.
• the subject interface is configured to place the pressure generator in fluid communication with the airway of the subject.
• the one or more sensors are configured to generate one or more output signals conveying information related to one or more parameters of the flow of gas.
• the one or more processors are configured to execute computer program modules.
• the computer program modules comprise a control module, an effectiveness module, and an adjustment module.
• the control module is configured to control the pressure generator according to the in-exsufflation therapy regime.
• Controlling the pressure generator according to the in- exsufflation therapy regime comprises causing the pressure generator to modulate a gas pressure within a respiratory phase between two or more pressure levels to generate a percussive pressure waveform during the respiratory phase, and monitoring the responsiveness of a flow rate of the flow of breathable gas to the modulations in pressure during the respiratory phase.
• the effectiveness module is configured to determine the effectiveness of the in-exsufflation therapy regime. The determination of effectiveness is based on the responsiveness of the flow rate to the modulations in pressure.
• the adjustment module is configured to adjust one or more parameters of the percussive pressure waveform to enhance the responsiveness of the flow rate.
• Yet another aspect of the present disclosure relates to a method to in- exsufllate a subject with an in-exsufflation system.
• the system comprises a pressure generator, a subject interface, one or more sensors, and one or more processors.
• the processor comprises a control module, an effectiveness module, and an adjustment module.
• the method comprises generating a flow of breathable gas for delivery to an airway of the subject according to an in-exsufflation therapy regime with the pressure generator; communicating the flow of breathable gas to the airway of the subject with the subject interface; generating output signals conveying information related to one or more gas parameters of the flow of breathable gas with the one or more sensors; executing computer program modules with the processor; controlling the pressure generator according to the in-exsufflation therapy regime with the control module, wherein controlling the pressure generator according to the in-exsufflation therapy regime comprises causing the pressure generator to modulate a gas pressure within a respiratory phase between two or more pressure levels to generate a percussive pressure waveform during the respiratory phase, and monitoring the responsiveness of a flow rate of the flow of breathable gas to the modulations in pressure during the respiratory phase; determining the effectiveness of the in-exsufflation therapy regime with the effectiveness module, the determination of effectiveness based on the responsiveness of the flow rate to the modulations in pressure; and adjusting one or more parameters of the percussive pressure
• Still another aspect of the present disclosure relates to a system configured to in-exsufflate a subject.
• the system comprises means for generating a flow of breathable gas for delivery to an airway of the subject according to an in-exsufflation therapy regime; means for communicating the flow of breathable gas to the airway of the subject; means for generating output signals conveying information related to one or more gas parameters of the flow of breathable gas; means for executing computer program modules; means for controlling the means for generating according to the in-exsufflation therapy regime, wherein controlling the means for generating according to the in- exsufflation therapy regime comprises causing the pressure generator to modulate a gas pressure within a respiratory phase between two or more pressure levels to generate a percussive pressure waveform during the respiratory phase, and monitoring the responsiveness of a flow rate of the flow of breathable gas to the modulations in pressure during the respiratory phase; means for determining the effectiveness of the in-exsufflation therapy regime, the determination of effectiveness based on the responsiveness of the flow rate to the modulations
• FIG. 1 schematically illustrates an exemplary embodiment of a system
• FIG. 2 shows an example of an applied percussive pressure waveform and the resulting oscillating flow rate waveform
• FIG. 3 shows another example of an applied percussive pressure waveform and the resulting oscillating flow rate waveform
• FIG. 4 illustrates a method to in-exsufflate a subject with an in-exsufflation system.
• the word "unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.
• the statement that two or more parts or components "engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
• the term “number” shall mean one or an integer greater than one (i.e., a plurality).
• FIG. 1 schematically illustrates an exemplary embodiment of a system 10 configured to in-exsufflate a subject 12.
• system 10 comprises a pressure generator 14, a subject interface 16, one or more sensors 18, one or more processors 20, electronic storage 22, a user interface 24, and/or other components.
• System 10 is configured to assist subject 12 to loosen and/or expel secretions by inducing a percussive pressure waveform delivered to subject 12 during inhalation and/or exhalation.
• System 10 is configured to control the in-exsuffiation therapy delivered to subject 12 without requiring regular manual setting and/or adjustment of pressures, pressure amplitudes, a frequency range, and/or other parameters of the percussive pressure waveform.
• Pressure generator 14 is configured to provide a pressurized flow of
• Pressure generator 14 receives a flow of gas from a gas source, such as the ambient atmosphere, and elevates the pressure of that gas for delivery to subject 12. In some embodiments, pressure generator 14 is configured to generate negative pressure to draw gas from subject 12. Pressure generator 14 is configured to modulate the pressure and/or frequency of the pressurized flow of breathable gas in accordance with the in- exsuffiation therapy regime. In some embodiments, pressure generator 14 is a device dedicated to inexsufflation. In some embodiments, pressure generator 14 is a ventilator and/or positive airway pressure device configured to provide therapy other than and/or in addition to inexsufflation.
• Pressure generator 14 may be configured such that one or more gas parameters of the pressurized flow of breathable gas in addition to and/or other than pressure are controlled in accordance with the therapy regime.
• the one or more gas parameters may include, for example, one or more of volume, flow rate, temperature, gas composition, velocity, acceleration, and/or other parameters.
• pressure generator 14 may include any device, such as, for example, a pump, blower, piston, or bellows, that is capable of elevating the pressure of the received gas for delivery to a patient.
• pressure generator 14 may include one or more devices, such as for example, a valve and/or a series of valves, capable of controlling the pressure, flow rate, flow direction, oscillation frequency, and/or other parameters of the flow of gas.
• pressure generator 14 may selectively control the flow direction of the flow of gas such that pressure levels during exsuffiation may be negative according to the in- exsufflation therapy regime.
• gas other than ambient atmospheric air may be introduced into system 10 for delivery to the patient.
• Subject interface 16 is configured to interface with the airway of subject
• Subject interface 16 is configured to provide fluid communication between pressure generator 14 and the airway of subject 12.
• subject interface 16 comprises a conduit 30, an interface appliance 32, and/or other components.
• Conduit 30 is configured to form a flow path through which the pressurized flow of breathable gas is communicated between pressure generator 14 and interface appliance 32.
• Conduit 30 may be a flexible length of hose, or other conduit, that places interface appliance 32 in fluid communication with pressure generator 14.
• Conduit 30 conveys gas (e.g., air) to and/or from interface appliance 32, and interface appliance 32 places conduit 30 in communication with the airway of subject 12.
• interface appliance 32 is non-invasive. As such, interface appliance 32 non-invasively engages subject 12.
• Non-invasive engagement includes removably engaging an area (or areas) surrounding one or more external orifices of the airway of subject 12 (e.g., nostrils and/or mouth) to communicate gas between the airway of subject 12 and subject interface 16.
• non-invasive interface appliance 32 may include, for example, a blow tube, a nasal cannula, a nasal mask, a nasal/oral mask, a full face mask, a total face mask, or other interface appliances that communicate a flow of gas with an airway of a subject.
• Sensors 18 are configured to generate output signals conveying
• the one or more gas parameters may comprise flow rate, pressure, volume, temperature, humidity, velocity, and/or other gas parameters.
• Sensors 18 may comprise one or more sensors that measure such parameters directly (e.g., through fluid communication with the flow of gas in subject interface 16).
• Sensors 18 may comprise one or more sensors that generate output signals related to one or more parameters of the flow of gas indirectly.
• one or more of sensors 18 may generate an output based on an operating parameter of the pressure generator 14 (e.g., a motor current, voltage, rotational velocity, and/or other operating parameters), and/or other sensors.
• sensors 18 are illustrated at a single location within (or in communication with) conduit 30 between interface appliance 32 and pressure generator 14, this is not intended to be limiting. Sensors 18 may include sensors disposed in a plurality of locations, such as for example, within pressure generator 14, within (or in communication with) interface appliance 32, and/or other locations.
• Processor 20 is configured to provide information processing capabilities in system 10.
• processor 20 may include one or more of a digital processor, an analog processor, a digital circuit designed to process information, an analog circuit designed to process information, a state machine, and/or other mechanisms for electronically processing information.
• processor 20 is shown in FIG. 1 as a single entity, this is for illustrative purposes only.
• processor 20 includes a plurality of processing units. These processing units may be physically located within the same device, or processor 20 may represent processing functionality of a plurality of devices operating in coordination.
• processor 20 may be configured to execute one or more computer program modules.
• the one or more computer program modules comprise one or more of a parameter module 40, a control module 42, an effectiveness module 44, an adjustment module 46, and/or other modules.
• Processor 20 may be configured to execute modules 40, 42, 44, and/or 46 by software; hardware; firmware; some combination of software, hardware, and/or firmware; and/or other mechanisms for configuring processing capabilities on processor 20.
• modules 40, 42, 44, and/or 46 may be located remotely from the other modules.
• the description of the functionality provided by the different modules 40, 42, 44, and/or 46 described below is for illustrative purposes, and is not intended to be limiting, as any of modules 40, 42, 44, and/or 46 may provide more or less functionality than is described.
• processor 20 may be configured to execute one or more additional modules that may perform some or all of the functionality attributed below to one of modules 40, 42, 44, and/or 46.
• Parameter module 40 is configured to determine one or more parameters within system 10.
• the one or more parameters within system 10 may comprise gas parameters related to the pressurized flow of breathable gas, breathing parameters related to the respiration of subject 12 and/or other parameters.
• Parameter module 40 is configured to determine the one or more parameters based on the output signals of sensors 18, and/or other information.
• the information determined by parameter module 40 may be used for controlling pressure generator 14, stored in electronic storage 24, displayed by user interface 24, and/or used for other uses.
• the one or more parameters determined by parameter module 40 may comprise, for example, one or more of a flow rate, pressure, a volume, humidity, temperature, acceleration, velocity, respiration rate, tidal volume, and/or other parameters.
• Control module 42 is configured to control pressure generator 14 to
• Control module 42 is configured to control pressure generator 14 based on information related to the output signals from sensors 18, information determined by parameter module 40, information entered by a user to user interface 24, and/or other information.
• Control module 42 is configured to control pressure generator 14 to
• Modulation of the pressure may comprise alternating the pressure delivered to subject 12 between two or more pressure levels within a respiratory phase, and/or controlling the frequency of pressure alternation.
• Control module 42 may be configured to cause pressure generator 14 to alternate pressure levels around a first local median pressure with a first amplitude during an inhalation of subject 12, and around a second local median pressure with a second amplitude during an exhalation of subject 12.
• the second local median pressure may be lower than the first median pressure.
• the second local median pressure and /or the alternating pressures around the second local median pressure may be negative pressures.
• Control module 42 is configured to control pressure generator 14 to reduce the median pressure of the pressurized flow of breathable gas for exsuffiation compared to insufflation with sufficient abruptness that expiratory flow through the airway of the subject is sufficient to remove mucus and/or other debris from the airway and/or lungs of the subject.
• the first amplitude and the second amplitude may be the same.
• FIG. 2 shows an applied percussive pressure waveform 200.
• Applied percussive pressure waveform 200 has a local median pressure 202 of about 37.5cm H 2 0 during inhalation 204, a local median pressure 206 of about negative 37.5 cm H 2 0 during exhalation 208, an amplitude 210 of 5cm H 2 0, and a frequency of 10Hz.
• local median pressure 206 during exhalation is lower than local median pressure 204 during inhalation and the transition between the two is abrupt.
• control module 42 is configured to determine initial percussive pressure waveform parameters (e.g., an initial first local median pressure, second local median pressure, amplitude, oscillation frequency) such that control module 42 may control pressure generator 14 to begin in-exsufflation therapy at the determined initial percussive pressure waveform parameters.
• Initial percussive pressure waveform parameters may be determined at manufacture, determined from information entered by a user via user interface 24, determined from previous respiration by subject 12, determined from information related to previous in-exsufflation therapy on subject 12, and/or determined by another method. From the initial starting amplitude, control module 42 is configured to ramp the percussive pressure waveform amplitude to a maximum amplitude over one or more respiratory phases. In some embodiments the maximum amplitude may be about 15cm of water. In some embodiments, the maximum amplitude may be about 10cm of water. In some embodiments, the maximum amplitude may be about 5cm of water.
• Control module 42 is configured to monitor the responsiveness of the flow rate of the flow of breathable gas to the applied modulations in pressure during the respiratory phase. Control module 42 is configured to monitor the responsiveness of the flow rate based on information related to the output signals from sensors 18, information determined by parameter module 40, and/or other information.
• the in-exsufflation therapy regime may dictate that the percussive pressure waveform is delivered to the airway of subject 12 starting at a first local median pressure during inhalation (e.g., 40cm H 2 0), a second local median pressure during exhalation (e.g., 10cm H 2 0), an initial amplitude (e.g., 5cm H 2 0), and an initial frequency (e.g., 10Hz).
• Control module 42 may control pressure generator 14 to steadily increase the amplitude of the waveform up to 10cm of water during a series of inhalations and exhalations by subject 12.
• control module 42 may control pressure generator
• Effectiveness module 44 is configured to determine the effectiveness of the in-exsufflation therapy regime. The determination of effectiveness is based on the responsiveness of the flow rate to the modulations in pressure. In some embodiments, effectiveness of the in-exsufflation therapy regime may be determined based on
• Information related to a parameter other than flow rate may be determined based on information related to the output signals from sensors 18, information determined by parameter module 40, information determined by control module 42, and/or other information. Increased responsiveness of the flow rate to the modulations in pressure indicates increased effectiveness. Increased oscillating flow rate amplitude indicates greater responsiveness.
• variable amplitude 214 is an indication of the responsiveness of the flow rate to the modulations in pressure. Increasing amplitude 214 indicates greater responsiveness.
• effectiveness module 44 may be configured to
• effectiveness module 44 may determine the effectiveness of the in-exsufflation therapy regime one or more times during a respiratory phase. In some embodiments, effectiveness module 44 may determine the effectiveness of the in-exsufflation therapy regime for one or more respiratory phases in a series of respiratory phases. In some embodiments, effectiveness module 44 may determine the effectiveness of the in-exsufflation therapy regime for one or more series of respirations by subject 12. Effectiveness module 44 may determine the effectiveness of the in-exsufflation therapy regime responsive to the initial application of in-exsufflation therapy by control module 42 and/or adjustments to the percussive pressure waveform made by adjustment module 46.
• effectiveness module 44 determines the oscillating flow rate amplitude after each pressure modulation. In some embodiments effectiveness module 44 may determine a flow rate amplitude after one or more pressure oscillations in a series of pressure oscillations (e.g., average flow rate amplitude). In some embodiments, effectiveness module 44 may determine a flow rate amplitude representative of the flow rate amplitude during inhalation (e.g., average flow rate amplitude during inhalation), and a flow rate amplitude representative of the flow rate amplitude during exhalation (e.g., average flow rate amplitude during exhalation.)
• Effectiveness module 44 is configured to determine an effectiveness
• Effectiveness module 44 is configured to compare the information indicating effectiveness (e.g., the amplitude of the oscillating flow rate) to the effectiveness threshold. Effectiveness module 42 is configured to determine that the in-exsufflation therapy regime is effective and/or ineffective based on the information indicating effectiveness relative to the effectiveness threshold. By way of a non-limiting example, when the amplitude of the oscillating flow rate breaches the effectiveness threshold, effectiveness module 44 may determine that the in-exsufflation therapy regime is effective. When the amplitude of the oscillating flow rate does not breach the effectiveness threshold, effectiveness module 44 may determine that the in-exsufflation therapy regime is ineffective.
• effectiveness module 44 may determine that the in-exsufflation therapy regime is ineffective.
• the effectiveness threshold may be configurable to a user (e.g., subject 12, a doctor, a caregiver, a researcher, and/or other users) through user interface 24, determined at manufacture, determined based on previous respiration by subject 12, determined based on information related to previous in-exsufflation therapy administered to subject 12, and/or determined by other methods.
• a user e.g., subject 12, a doctor, a caregiver, a researcher, and/or other users
• user interface 24 determined at manufacture, determined based on previous respiration by subject 12, determined based on information related to previous in-exsufflation therapy administered to subject 12, and/or determined by other methods.
• Adjustment module 46 is configured to adjust one or more parameters of the percussive pressure waveform to enhance the responsiveness of the flow rate of the flow of breathable gas. Adjustment module 46 is configured to adjust the one or more parameters of the percussive pressure waveform responsive to a determination by effectiveness module 44 that the in-exsufflation therapy regime is not effective.
• adjustment module 46 is configured to control pressure generator 14 to sweep the percussive pressure waveform through one or more frequencies in a frequency range.
• the frequency range may be determined at manufacture, determined from information entered by a user via user interface 24, determined from previous respiration by subject 12, determined from information related to previous in-exsufflation therapy on subject 12, and/or determined by another method.
• Adjustment module 46 is configured to stop sweeping the percussive pressure waveform through the one or more frequencies in the frequency range responsive to a determination by effectiveness module 44 that the in- exsufflation therapy regime is effective, and/or when one or more limits of the frequency range are reached.
• adjustment module 46 may be configured to adjust the local median pressures, the amplitude, and/or other parameters of the percussive pressure waveform in addition to and/or instead of the frequency. In some embodiments, adjustment module 46 may be configured to optimize the parameters of the percussive pressure waveform (e.g., pressure, amplitude, frequency) to achieve a maximum oscillating flow rate amplitude. Adjustment module 46 may be configured to optimize the parameters of the percussive pressure waveform to achieve a maximum oscillating flow rate amplitude in an ongoing manner during an in-exsufflation therapy session. In some embodiments, adjustment module 46 may be configured to adjust one or more parameters of the percussive waveform differently for inhalation compared to exhalation.
• parameters of the percussive pressure waveform e.g., pressure, amplitude, frequency
• FIG. 2 shows applied percussive pressure waveform
• FIG. 2 may represent the initial in- exsufflation therapy percussive pressure waveform generated by a pressure generator (e.g., pressure generator 14 shown in FIG. 1) under the control of a processor control module (e.g., control module 42 shown in FIG. 1).
• the initial percussive pressure waveform shown in FIG. 2 may represent ineffective in-exsufflation therapy.
• FIG. 3 shows another example of an applied percussive pressure waveform
• the percussive pressure waveform shown in FIG. 3 may represent effective in-exsufflation therapy.
• FIG. 3 may represent the in-exsufflation therapy percussive pressure waveform generated by a pressure generator (e.g., pressure generator 14 shown in FIG. 1) after adjustment by a processor adjustment module (e.g., adjustment module 46 shown in FIG. 1) responsive to a determination of ineffectiveness by a processor effectiveness module (e.g., effectiveness module 44 shown in FIG. 1).
• a pressure generator e.g., pressure generator 14 shown in FIG. 1
• a processor adjustment module e.g., adjustment module 46 shown in FIG. 1
• effectiveness module e.g., effectiveness module 44 shown in FIG. 1
• the local median pressures, the amplitude, and the frequency are adjusted relative to FIG. 2.
• FIG. 2 the local median pressures, the amplitude, and the frequency are adjusted relative to FIG. 2.
• the applied percussive pressure waveform 300 has a local median pressure 302 of about 36cm H 2 0 during inhalation 304, a local median pressure 306 of about negative 36 cm H 2 O during exhalation 308, an amplitude 310 of 7.5cm H 2 0, and a frequency of 5Hz.
• the resulting oscillating flow rate waveform 312 has a variable amplitude 314.
• Amplitude 314 of oscillating flow rate waveform 312 is larger relative to amplitude 214 shown in FIG. 2. According to the description provided above with respect to FIG. 1, the larger amplitude 314 of flow rate waveform 312 indicates that applied percussive waveform 300 is more effective than applied percussive waveform 200.
• electronic storage 22 comprises electronic storage media that electronically stores information.
• the electronic storage media of electronic storage 22 may comprise one or both of system storage that is provided integrally (i.e., substantially non-removable) with system 10 and/or removable storage that is removably connectable to system 10 via, for example, a port (e.g., a USB port, a firewire port, etc.) or a drive (e.g., a disk drive, etc.).
• a port e.g., a USB port, a firewire port, etc.
• a drive e.g., a disk drive, etc.
• Electronic storage 22 may comprise one or more of optically readable storage media (e.g., optical disks, etc.), magnetically readable storage media (e.g., magnetic tape, magnetic hard drive, floppy drive, etc.), electrical charge-based storage media (e.g., EPROM, RAM, etc.), solid-state storage media (e.g., flash drive, etc.), and/or other electronically readable storage media.
• Electronic storage 22 may store software algorithms, information determined by processor 20, information received via user interface 24, and/or other information that enables system 10 to function properly.
• Electronic storage 22 may be (in whole or in part) a separate component within system 10, or electronic storage 22 may be provided (in whole or in part) integrally with one or more other components of system 10 (e.g., pressure generator 14, processor 20, etc.).
• information determined by processor 20 and stored by electronic storage 22 may comprise information related to previous respiration by subject 12, information related to previous in-exsuffiation therapy on subject 12 by system 10, and/or other information.
• User interface 24 is configured to provide an interface between system 10 and subject 12 through which subject 12 provides information to and receives information from system 10. This enables data, results, and/or instructions and any other
• communicable items collectively referred to as "information," to be communicated between subject 12 and one or more of subject interface 16, processor 20, and/or other components of system 10.
• interface devices suitable for inclusion in user interface 24 include a keypad, buttons, switches, a keyboard, knobs, levers, a display screen, a touch screen, speakers, a microphone, a printer, and/or other interface devices.
• user interface 24 includes a plurality of separate interfaces. It is to be understood that other communication techniques, either hard- wired or wireless, are also contemplated by the present disclosure as user interface 24.
• exemplary input devices and techniques adapted for use with system 10 as user interface 24 include, but are not limited to, an RS-232 port, RF link, an IR link, modem (telephone, cable or other).
• any technique for communicating information with system 10 is contemplated by the present disclosure as user interface 24.
• a user may enter a threshold value for the oscillating flow rate amplitude through user interface 24.
• information entered by a user through user interface is a user entered by a user through user interface
• a therapy regime e.g., inexsufflation, CPAP, etc.
• in-exsufflation therapy initial percussive pressure waveform parameters
• frequency range e.g., a range of a therapy regime
• oscillating flow rate amplitude effectiveness threshold e.g., a flow rate amplitude effectiveness threshold
• FIG. 4 illustrates a method 400 to in-exsuffiate a subject with an inexsufflation system.
• the system comprises a pressure generator, a subject interface, one or more sensors, and one or more processors.
• the processor comprises a control module, an effectiveness module, and an adjustment module.
• the operations of method 400 presented below are intended to be illustrative. In some embodiments, method 400 may be accomplished with one or more additional operations not described, and/or without one or more of the operations discussed. Additionally, the order in which the operations of method 400 are illustrated in FIG. 4 and described below is not intended to be limiting.
• method 400 may be implemented in one or more processing devices (e.g., a digital processor, an analog processor, a digital circuit designed to process information, an analog circuit designed to process information, a state machine, and/or other mechanisms for electronically processing information).
• the one or more processing devices may include one or more devices executing some or all of the operations of method 400 in response to instructions stored electronically on an electronic storage medium.
• the one or more processing devices may include one or more devices configured through hardware, firmware, and/or software to be specifically designed for execution of one or more of the operations of method 400.
• a pressurized flow of breathable gas is generated for delivery to an airway of a subject according to an in-exsufflation therapy regime.
• operation 402 is performed by a pressure generator the same as or similar to pressure generator 14 (shown in FIG. 1 and described herein).
• operation 404 is performed by a subject interface the same as or similar to subject interface 16 (shown in FIG. 1 and described herein).
• output signals conveying information related to one or more gas parameters of the flow of breathable gas are generated.
• operation 406 is performed by sensors the same as or similar to sensors 18 (shown in FIG. 1 and described herein).
• operation 408 computer program modules are executed.
• operation 408 is performed by a processor the same as or similar to processor 20 (shown in FIG. 1 and describe herein).
• the pressure generator is controlled according to the in-exsufflation therapy regime. In some embodiments, operation 410 is performed by a processor module the same as or similar to control module 42 (shown in FIG. 1 and described herein). [50] At an operation 412, the pressure generator is caused to modulate a gas pressure within a respiratory phase between two or more pressure levels to generate a percussive pressure waveform during the respiratory phase. In some embodiments, operation 412 is performed by a processor module the same as or similar to control module 42 (shown in FIG. 1 and described herein).
• operation 414 is performed by a processor module the same as or similar to control module 42 (shown in FIG. 1 and described herein).
• operation 416 the effectiveness of the in-exsufflation therapy regime is determined. The determination of effectiveness is based on the responsiveness of the flow rate to the modulations in pressure.
• operation 416 is performed by a processor module the same as or similar to effectiveness module 44 (shown in FIG. 1 and described herein).
• operation 418 one or more parameters of the percussive pressure waveform are adjusted to enhance the responsiveness of the flow rate.
• operation 418 is performed by a processor module the same as or similar to adjustment module 46 (shown in FIG. 1 and described herein).
• any reference signs placed between parentheses shall not be construed as limiting the claim.
• the word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim.
• several of these means may be embodied by one and the same item of hardware.
• the word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements.
• any device claim enumerating several means several of these means may be embodied by one and the same item of hardware.
• the mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

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• 2013
  • 2013-05-24 WO PCT/IB2013/054289 patent/WO2013182944A1/en not_active Ceased
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