Respiratory humidification device and method of operation

Abstract

A respiratory humidification device is described, the respiratory humidification device comprising: a moisture exchanger positioned in a respiratory system having an inhalation and exhalation respiratory cycle, the moisture exchanger positioned such that airflow generated in the inhalation and exhalation respiratory cycle contacts the moisture exchanger, the moisture exchanger being temperature responsive and having a critical solution temperature; a heater; and a controller controlling power supply to the heater, the heater raising the temperature of the moisture exchanger to or above a first target temperature proximate to an approximately first target point in the respiratory cycle, the temperature of the moisture exchanger decreasing to or below a second target temperature proximate to an approximately second target point in the respiratory cycle and the first target temperature increasing above the second target temperature, wherein during inspiration moisture is added to the incoming air and during expiration the moisture exchanger extracts moisture from the air.

Description

Technical Field

[0001] The present invention relates to a respiratory humidification device and an operation method.

Background Art

[0002] Some patients use a breathing inhaler, a positive airway pressure device (including PAP, CPAP, APAP, and BiPAP), an anesthetic machine, a ventilator, or even a respiratory assistance device such as a tracheostomy to restore or provide an appropriate breathing cycle. These treatments interfere with the natural lubrication and normal air conditioning process. The reason is that increased pressure and turbulent flow effects occur, or the nasal cavity, which is the most important air conditioning part, is bypassed. The breathing device may cause drying and trauma of the mucosa in the part where the ciliated cells are inactivated and reduced (Malik & Kenyon, 2004). Therefore, the inhaled air flow needs to be warmed and humidified in order to reach the lungs at 37°C with a relative humidity of almost 100% and to maintain the optimal mucociliary transport function.

[0003] This air flow is delivered to the patient (or, in some cases, a non-patient user) through a patient interface such as a face mask, nasal mask, nasal pillow mask, tracheostomy tube, endotracheal tube, or cloth face mask. Between the respiratory assistance device and the patient interface, there are generally tubes, valves, Y-shaped connectors, suction ports, sampling ports, etc. together with what is generally known as a breathing circuit. The types of patient interface and breathing circuit are determined by the application.

[0004] International Publication No. 2019 / 093910 discloses a moisture exchanger that is heated to change from hydrophilic to hydrophobic (or vice versa), and a respiratory humidification device including the moisture exchanger and a heating element. The respiratory humidification device can receive the air flow supplied from the respiratory assistance device or can heat and humidify the ambient air.

[0005] The moisture exchanger in a respiratory humidifier device comprises a temperature-responsive polymer and a substrate that physically supports the temperature-responsive polymer to maintain a desired shape, providing a large number of polymer surfaces for positioning the polymer in contact with the inspiratory and expiratory airflows. Examples of substrates that may be suitable include fibrous materials such as natural fibers (especially cotton, linen, chitin, or chitosan), synthetic or processed fibers (especially rayon, polyvinyl alcohol (PVA), or polypropylene (PP)), or mixtures thereof. Quality include.

[0006] Temperature-responsive polymers can be grafted onto a substrate. . country Appropriate temperature-responsive polymers are disclosed in International Publication No. 2019 / 093910.

[0007] It is recognized that the terms “comprise,” “comprises,” and “comprising” may be given either an exclusive or comprehensive meaning in various jurisdictions. For the purposes of this specification and unless otherwise specified, these terms are intended to have a comprehensive meaning; that is, their use means the inclusion of the described components in which they are directly referred, and, where applicable, also the inclusion of other undescribed components or elements.

[0008] The term "airflow" is widely used and may include, for example, a flow of oxygen-enriched air, an anesthetic gas, or pure oxygen.

[0009] With respect to any reference in this specification, we do not acknowledge that the reference is prior art, is effectively combinable with other references, or forms part of common general knowledge.

[0010] The object of the present invention is to develop an improved respiratory humidification device for hygienic use, or at least to provide a useful alternative to the public or industry. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] International Publication No. 2019 / 093910 [Non-patent literature]

[0012] [Non-Patent Document 1] Malik & Kenyon, 2004 [Overview of the Initiative] [Means for solving the problem]

[0013] According to one exemplary embodiment, a respiratory humidification device is provided, and the respiratory humidification device is A moisture exchanger positioned in a respiratory system having an inspiratory and expiratory breathing cycle, wherein the moisture exchanger is positioned so that the airflow generated in the inspiratory and expiratory breathing cycle comes into contact with the moisture exchanger, and the moisture exchanger is temperature-responsive and has a critical solution temperature. A heater and It includes a controller that controls the power supply to the heater, and the controller allows The heater controls the temperature of the moisture exchanger during the respiratory cycle. The first Target point 1 In, Raise the temperature to a first target temperature, or raise it above the first target temperature. The temperature of the moisture exchanger is important during the respiratory cycle. The first Target point 2 In, To the second target temperature Descending or below the second target temperature Descending , The first target temperature exceeds the second target temperature, moisture is added to the incoming air during inhalation, and moisture is extracted from the air by the moisture exchanger during exhalation.

[0014] Preferably, the system further includes a power supply for supplying power to the heater.

[0015] Preferably, the first target temperature is higher than the second target temperature.

[0016] Preferably, the first target temperature is higher than the critical solution temperature.

[0017] Preferably, the first target temperature is at least 0.5 °C higher than the critical solution temperature.

[0018] Preferably, the first target temperature is at least 1 °C higher than the critical solution temperature.

[0019] Preferably, the second target temperature is lower than the critical solution temperature.

[0020] Preferably, the second target temperature is at least 0.5 °C lower than the critical solution temperature.

[0021] Preferably, the second target temperature is at least 1 °C lower than the critical solution temperature.

[0022] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point is at least in the intake air existence to do.

[0023] Preferably, the moisture exchanger is heated at least in the intake air.

[0024] Preferably, the LCST is 25 °C to 50 °C.

[0025] Preferably, the LCST is 30 °C to 45 °C.

[0026] [[ID=4�]] Preferably, the first target point is at the start of the intake air.

[0027] Preferably, the controller Before the respiratory flow rate changes from exhalation to inhalation, increases the heater power and is Hi turns on the switch of the - ter.

[0028] Preferably, the second target point is at the start of exhalation.

[0029] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Reduce heater power, is Hi Turn off the heater switch.

[0030] Preferably, the critical solution temperature is the upper critical solution temperature (UCST), and the first target point is at least in the exhaled air. existence do.

[0031] Preferably, the moisture exchanger is heated at least during intake.

[0032] Preferably, UCST is between 20°C and 50°C.

[0033] Preferably, UCST is 30°C to 45°C.

[0034] Preferably, the first target point is at the start of exhalation.

[0035] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Increase heater power, is Hi Turn on the heater switch.

[0036] Preferably, the second target point is at the start of intake.

[0037] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Reduce heater power, is Hi Turn off the heater switch.

[0038] Preferably, the heater comprises at least, heating Elements, filaments, spiral wires, induction coils, radiation heater The group is selected from the group consisting of, and infrared heaters.

[0039] Preferably, the respiratory humidifier device further includes a bias vent.

[0040] Preferably, the respiratory humidification device further includes a water source.

[0041] Preferably, the controller further includes a user interface for adjusting its operation.

[0042] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0043] Preferably, the controller is a processor.

[0044] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0045] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0046] Preferably, the system further includes sensors, and the controller operates in response to information received from the sensors.

[0047] Preferably, the first or second target temperature is adjustable according to the desired inhaled air temperature or the mode of the respiratory humidifier device.

[0048] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0049] Preferably, it is further equipped with a bacterial filter.

[0050] According to one exemplary embodiment, a method is provided for controlling the release and absorption of water vapor from a moisture exchanger that provides humidified air in a breathing system having an inspiratory and expiratory breathing cycle, wherein the moisture exchanger is positioned so that the airflow generated in the inspiratory and expiratory breathing cycle comes into contact with the moisture exchanger, the moisture exchanger is temperature responsive and has a critical solution temperature, and the method uses a controller to control the temperature of the moisture exchanger with a heater during the breathing cycle. The first Target point 1 In, The temperature of the moisture exchanger is controlled in the respiratory cycle by controlling the power supply to the heater to raise it to a target temperature or to a first target temperature. The first Target point 2 In, To the second target temperature Descending or below the second target temperature Descending During inhalation, moisture is added to the incoming air, and during exhalation, the moisture exchanger extracts moisture from the air.

[0051] Preferably, the first target temperature is higher than the second target temperature.

[0052] Preferably, the first target temperature is above the critical solution temperature.

[0053] Preferably, the first target temperature is at least 0.5°C higher than the critical solution temperature.

[0054] Preferably, the first target temperature is at least 1°C higher than the critical solution temperature.

[0055] Preferably, the second target temperature is below the critical solution temperature.

[0056] Preferably, the second target temperature is at least 0.5°C lower than the critical solution temperature.

[0057] Preferably, the second target temperature is at least 1°C lower than the critical solution temperature.

[0058] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point is in the intake air. existence do.

[0059] Preferably, the moisture exchanger is heated at least during intake.

[0060] Preferably, the LCST is 25°C to 50°C.

[0061] Preferably, the LCST is 30°C to 45°C.

[0062] Preferably, the first target point is at the start of intake.

[0063] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Increase heater power, is Hi Turn on the heater switch.

[0064] Preferably, the second target point is at the start of exhalation.

[0065] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Reduce heater power, is Hi Turn off the heater switch.

[0066] Preferably, the critical solution temperature is the upper critical solution temperature (UCST), and the first target point is at least in the exhaled air. existence do.

[0067] Preferably, the moisture exchanger is heated at least during intake.

[0068] Preferably, UCST is between 20°C and 50°C.

[0069] Preferably, UCST is 30°C to 45°C.

[0070] Preferably, the first target point is at the start of exhalation.

[0071] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Increase heater power, is Hi Turn on the heater switch.

[0072] Preferably, the second target point is at the start of intake.

[0073] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Reduce heater power, is Hi Turn off the heater switch.

[0074] Preferably, the heater comprises at least, heating Elements, filaments, spiral wires, induction coils, radiation heater The group is selected from the group consisting of, and infrared heaters.

[0075] Preferably, the moisture exchanger further includes a user interface for adjusting the operation of the controller.

[0076] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0077] Preferably, the controller is a processor.

[0078] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0079] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0080] Preferably, the moisture exchanger further includes a sensor, and the method further includes a controller operating in response to information received from the sensor.

[0081] The method further includes adjusting a first target temperature or a second target temperature depending on the desired intake air temperature or the mode of the moisture exchanger.

[0082] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0083] According to one exemplary embodiment, a moisture exchanger is provided configured for use in a respiratory humidification device, wherein the moisture exchanger is temperature-responsive and has a critical solution temperature, and the respiratory humidification device is A heater and It includes a controller that controls the power supply to the heater, and the controller allows The heater controls the temperature of the moisture exchanger during the respiratory cycle. The first Target point 1 In the first Raise the temperature to the target temperature, or raise it to a temperature above the first target temperature. The temperature of the moisture exchanger is important during the respiratory cycle. The first Target point 2 In, To the second target temperature Descending or below the second target temperature Descending , During inhalation, moisture is added to the incoming air, and during exhalation, the moisture exchanger extracts moisture from the air.

[0084] Preferably, the system further includes a power supply for supplying power to the heater.

[0085] Preferably, the first target temperature is higher than the second target temperature.

[0086] Preferably, the first target temperature is above the critical solution temperature.

[0087] Preferably, the first target temperature is at least 0.5°C higher than the critical solution temperature.

[0088] Preferably, the first target temperature is at least 1°C higher than the critical solution temperature.

[0089] Preferably, the second target temperature is below the critical solution temperature.

[0090] Preferably, the second target temperature is at least 0.5°C lower than the critical solution temperature.

[0091] Preferably, the second target temperature is at least 1°C lower than the critical solution temperature.

[0092] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point is in the intake air. existence do.

[0093] Preferably, the moisture exchanger is heated at least during intake.

[0094] Preferably, the LCST is 25°C to 50°C.

[0095] Preferably, the LCST is 30°C to 45°C.

[0096] Preferably, the first target point is at the start of intake.

[0097] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Increase heater power, is Hi Turn on the heater switch.

[0098] Preferably, the second target point is at the start of exhalation.

[0099] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Reduce heater power, is Hi Turn off the heater switch.

[0100] Preferably, the critical solution temperature is the upper critical solution temperature (UCST), and the first target point is at least in the exhaled air. existence do.

[0101] Preferably, the moisture exchanger is heated at least during intake.

[0102] Preferably, UCST is between 20°C and 50°C.

[0103] Preferably, UCST is 30°C to 45°C.

[0104] Preferably, the first target point is at the start of exhalation.

[0105] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Increase heater power, is Hi Turn on the heater switch.

[0106] Preferably, the second target point is at the start of intake.

[0107] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Reduce heater power, is Hi Turn off the heater switch.

[0108] Preferably, the heater comprises at least, heating Elements, filaments, spiral wires, radiation heater The group is selected from the group consisting of, and infrared heaters.

[0109] Preferably, it further includes a bias vent.

[0110] Preferably, additional water sources are provided.

[0111] Preferably, the controller further includes a user interface for adjusting its operation.

[0112] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0113] Preferably, the controller is a processor.

[0114] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0115] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0116] Preferably, the system further includes sensors, and the controller operates in response to information received from the sensors.

[0117] Preferably, the first or second target temperature is adjustable according to the desired intake air temperature or the mode of the moisture exchanger.

[0118] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0119] Preferably, it is further equipped with a bacterial filter.

[0120] According to one exemplary embodiment, a respiratory humidification device is provided, and the respiratory humidification device is A moisture exchanger positioned in a respiratory system having an inspiratory and expiratory breathing cycle, wherein the moisture exchanger is positioned so that the airflow generated in the inspiratory and expiratory breathing cycle comes into contact with the moisture exchanger, and the moisture exchanger is temperature-responsive and has a critical solution temperature. A heater and The system includes a controller that controls the power supply to the heater so that the power to the heater decreases before exhalation begins, During inhalation, moisture is added to the incoming air, and during exhalation, the moisture exchanger extracts moisture from the air.

[0121] Preferably, the system further includes a power supply for supplying power to the heater.

[0122] Preferably, the controller reduces the power to the heater to less than 5% of the available power.

[0123] Preferably, the controller initiates exhalation. Rather At least 500ms in front This reduces the power supplied to the heater.

[0124] Preferably, the controller initiates exhalation. Rather At least 250ms in front This reduces the power supplied to the heater.

[0125] Preferably, the controller controls the respiratory cycle of inspiration and expiration. Features present within Based on this, reduce power consumption.

[0126] Preferably, Key Features This is calculated based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0127] Preferably, the threshold is calculated over multiple respiratory cycles.

[0128] Preferably, the controller further controls the power supply to the heater so that the power to the heater increases before the intake air starts.

[0129] Preferably, the controller increases the power to the heater to a power level greater than 90% of the available power.

[0130] Preferably, the controller initiates the intake. Rather At least 500ms in front This increases the power supplied to the heater.

[0131] Preferably, the controller initiates exhalation. Rather At least 250ms in front This increases the power supplied to the heater.

[0132] Preferably, the controller is present during the inspiratory and expiratory respiratory cycles. Key Features Based on this, increase the power.

[0133] Preferably, Key Features This is calculated based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0134] Preferably, the threshold is calculated over multiple respiratory cycles.

[0135] Preferably, the controller controls the heater to maintain the temperature of the moisture exchanger during the respiratory cycle. The first Target point 1 In, Raise the temperature to a first target temperature, or raise it above the first target temperature, and raise the temperature of the moisture exchanger of , in the respiratory cycle The first Target point 2 In, To the second target temperature Lower or below the second target temperature Lower it .

[0136] Preferably, the first target temperature is higher than the second target temperature.

[0137] Preferably, the first target temperature is above the critical solution temperature.

[0138] Preferably, the first target temperature is at least 0.5°C higher than the critical solution temperature.

[0139] Preferably, the first target temperature is at least 1°C higher than the critical solution temperature.

[0140] Preferably, the second target temperature is below the critical solution temperature.

[0141] Preferably, the second target temperature is at least 0.5°C lower than the critical solution temperature.

[0142] Preferably, the second target temperature is at least 1°C lower than the critical solution temperature.

[0143] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point is at least in the intake air. existence do.

[0144] Preferably, the moisture exchanger is heated at least during intake.

[0145] Preferably, the LCST is 25°C to 50°C.

[0146] Preferably, the LCST is 30°C to 45°C.

[0147] Preferably, the first target point is at the start of intake.

[0148] Preferably, the second target point is at the start of exhalation.

[0149] Preferably, the critical solution temperature is the upper critical solution temperature of ,°C (UCST), and the first target point is at least in the exhaled air. existence do.

[0150] Preferably, UCST is between 20°C and 50°C.

[0151] Preferably, UCST is 30°C to 45°C.

[0152] Preferably, the first target point is at the start of exhalation.

[0153] Preferably, the second target point is at the start of intake.

[0154] Preferably, the first or second target temperature is adjustable according to the desired inhaled air temperature or the mode of the respiratory humidifier device.

[0155] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0156] Preferably, the heater comprises at least, heating Elements, filaments, spiral wires, induction coils, radiation heater The group is selected from the group consisting of, and infrared heaters.

[0157] Preferably, it further includes a bias vent.

[0158] Preferably, additional water sources are provided.

[0159] Preferably, the controller further includes a user interface for adjusting its operation.

[0160] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0161] Preferably, the controller is a processor.

[0162] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0163] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0164] Preferably, the system further includes sensors, and the controller operates in response to information received from the sensors.

[0165] Preferably, it is further equipped with a bacterial filter.

[0166] According to one exemplary embodiment, a method is provided for controlling the release and absorption of water vapor from a moisture exchanger that provides humidified air in a breathing system having an inspiratory and expiratory breathing cycle, wherein the moisture exchanger is positioned such that the airflow generated in the inspiratory and expiratory breathing cycle comes into contact with the moisture exchanger, the moisture exchanger is temperature responsive and has a critical solution temperature, and the method includes controlling the heater by using a controller to control the power supply to the heater, thereby controlling the power supply to the heater so that the power to the heater decreases before the start of exhalation and during inspiration. to Moisture is added to the incoming air, and in the exhaled breath. to A moisture exchanger extracts moisture from the air.

[0167] Preferably, the controller reduces the power to the heater to less than 5% of the available power.

[0168] Preferably, the controller initiates exhalation. Rather At least 500ms in front This reduces the power supplied to the heater.

[0169] Preferably, the controller initiates exhalation. Rather At least 250ms in front This reduces the power supplied to the heater.

[0170] Preferably, the controller controls the respiratory cycle of inspiration and expiration. Features present within Based on this, reduce power consumption.

[0171] Preferably, Key Features This is calculated by the controller based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0172] Preferably, the threshold is calculated by the controller over multiple respiratory cycles.

[0173] Preferably, the controller further controls the power supply to the heater so that the power to the heater increases before the intake air starts.

[0174] Preferably, the controller increases the power to the heater to a power level greater than 90% of the available power.

[0175] Preferably, the controller initiates the intake. Rather At least 500ms in front This increases the power supplied to the heater.

[0176] Preferably, the controller initiates exhalation. Rather At least 250ms in front This increases the power supplied to the heater.

[0177] Preferably, the controller controls the respiratory cycle of inspiration and expiration. Features present within Based on this, increase the power.

[0178] Preferably, Key Features This is calculated by the controller based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0179] Preferably, the threshold is calculated by the controller over multiple respiratory cycles.

[0180] Preferably, the controller that controls the heater controls the temperature of the moisture exchanger in the respiratory cycle. The first Target point 1 In, Raise the temperature to a first target temperature, or raise it above the first target temperature, and raise the temperature of the moisture exchanger of , in the respiratory cycle The first Target point 2 In, Decreasing to the second target temperature Let or fall below a second target temperature Let .

[0181] Preferably, the first target temperature is higher than the second target temperature.

[0182] Preferably, the first target temperature is above the critical solution temperature.

[0183] Preferably, the first target temperature is at least 0.5°C higher than the critical solution temperature.

[0184] Preferably, the first target temperature is at least 1°C higher than the critical solution temperature.

[0185] Preferably, the second target temperature is below the critical solution temperature.

[0186] Preferably, the second target temperature is at least 0.5°C lower than the critical solution temperature.

[0187] Preferably, the second target temperature is at least 1°C lower than the critical solution temperature.

[0188] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point is in the intake air. existence do.

[0189] Preferably, the moisture exchanger is heated at least during intake.

[0190] Preferably, the LCST is 25°C to 50°C.

[0191] Preferably, the LCST is 30°C to 45°C.

[0192] Preferably, the first target point is at the start of intake.

[0193] Preferably, the controller is Before the respiratory flow rate changes from exhalation to inhalation, Increase heater power, is Hi Turn on the heater switch.

[0194] Preferably, the second target point is at the start of exhalation.

[0195] Preferably, the critical solution temperature is the upper critical solution temperature (UCST), and the first target point is at least in the exhaled air. existence do.

[0196] Preferably, the moisture exchanger is heated at least during intake.

[0197] Preferably, UCST is between 20°C and 50°C.

[0198] Preferably, UCST is 30°C to 45°C.

[0199] Preferably, the first target point is at the start of exhalation.

[0200] Preferably, the controller is Before the respiratory flow rate changes from inspiration to expiration, Increase heater power, is Hi Turn on the heater switch.

[0201] Preferably, the second target point is at the start of intake.

[0202] The method further includes adjusting a first target temperature or a second target temperature depending on the desired intake air temperature or the mode of the moisture exchanger.

[0203] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0204] Preferably, the heater comprises at least, heating Elements, filaments, spiral wires, induction coils, radiation heater The group is selected from the group consisting of, and infrared heaters.

[0205] Preferably, the moisture exchanger further includes a user interface for adjusting the operation of the controller.

[0206] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0207] Preferably, the controller is a processor.

[0208] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0209] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0210] Preferably, the moisture exchanger further includes a sensor, and the method further includes a controller operating in response to information received from the sensor.

[0211] According to one exemplary embodiment, a moisture exchanger is provided configured for use in a respiratory humidification device, wherein the moisture exchanger is temperature-responsive and has a critical solution temperature, and the respiratory humidification device is A heater and A controller that controls the power to the heater so that the power to the heater decreases before exhalation begins, During intake to Moisture is added to the incoming air, and in the exhaled breath. to A moisture exchanger extracts moisture from the air.

[0212] Preferably, the system further includes a power supply for supplying power to the heater.

[0213] Preferably, the controller reduces the power to the heater to less than 5% of the available power.

[0214] Preferably, the controller initiates exhalation. Rather At least 500ms in front This reduces the power supplied to the heater.

[0215] Preferably, the controller initiates exhalation. Rather At least 250ms in front This reduces the power supplied to the heater.

[0216] Preferably, the controller controls the respiratory cycle of inspiration and expiration. Features present within Based on this, reduce power consumption.

[0217] Preferably, Key Features This is calculated based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0218] Preferably, the threshold is calculated over multiple respiratory cycles.

[0219] Preferably, the controller further controls the power supply to the heater so that the power to the heater increases before the intake air starts.

[0220] Preferably, the controller increases the power to the heater to a power level greater than 90% of the available power.

[0221] Preferably, the controller initiates the intake. Rather At least 500ms in front This increases the power supplied to the heater.

[0222] Preferably, the controller initiates exhalation. Rather At least 250ms in front This increases the power supplied to the heater.

[0223] Preferably, the controller controls the respiratory cycle of inspiration and expiration. Features present within Based on this, increase the power.

[0224] Preferably, Key Features This is calculated based on transitions from a value above a threshold to a value below a threshold, or vice versa.

[0225] Preferably, the threshold is calculated over multiple respiratory cycles.

[0226] Preferably, the controller that controls the heater controls the temperature of the moisture exchanger in the respiratory cycle. The first Target point 1 In, Raise the temperature to a first target temperature, or raise it above the first target temperature, and raise the temperature of the moisture exchanger of , in the respiratory cycle The first Target point 2 In, To the second target temperature Lower or below the second target temperature Lower it .

[0227] Preferably, the first target temperature is higher than the second target temperature.

[0228] Preferably, the first target temperature is above the critical solution temperature.

[0229] Preferably, the first target temperature is at least 0.5°C higher than the critical solution temperature.

[0230] Preferably, the first target temperature is at least 1°C higher than the critical solution temperature.

[0231] Preferably, the second target temperature is below the critical solution temperature.

[0232] Preferably, the second target temperature is at least 0.5°C lower than the critical solution temperature.

[0233] Preferably, the second target temperature is at least 1°C lower than the critical solution temperature.

[0234] Preferably, the critical solution temperature is the lower critical solution temperature (LCST), and the first target point occurs during intake.

[0235] Preferably, the LCST is 25°C to 50°C.

[0236] Preferably, the LCST is 30°C to 45°C.

[0237] Preferably, the first target point is at the start of inhalation.

[0238] Preferably, the second target point is at the start of exhalation.

[0239] Preferably, the critical solution temperature is the upper critical solution temperature (UCST), and the first target point is at least during exhalation existence to occur.

[0240] Preferably, the UCST is 20°C to 50°C.

[0241] Preferably, the UCST is 30°C to 45°C.

[0242] Preferably, the first target point is at the start of exhalation.

[0243] Preferably, the second target point is at the start of inhalation.

[0244] Preferably, the first target temperature or the second target temperature can be adjusted according to the desired intake air temperature or the mode of the moisture exchanger.

[0245] Preferably, the mode is invasive ventilation or non-invasive ventilation.

[0246] Preferably, the heater is at least heating an element, a filament, a spiral wire, a radiation heater , and is selected from the group consisting of an infrared heater.

[0247] Preferably, it further comprises a bias vent.

[0248] Preferably, it further comprises a water source.

[0249] Preferably, the controller further includes a user interface for adjusting its operation.

[0250] Preferably, the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

[0251] Preferably, the controller is a processor.

[0252] Preferably, the controller is a predictive controller based on one or more of the following: time offset, quiescent time, and flow rate.

[0253] Preferably, the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

[0254] Preferably, the system further includes sensors, and the controller operates in response to information received from the sensors.

[0255] Preferably, it is further equipped with a bacterial filter.

[0256] The accompanying drawings, incorporated into the specification and constituting part of the specification, illustrate embodiments of the present invention and, together with the summary of the invention given above and the embodiments given below, are useful in illustrating the principles of the present invention. [Brief explanation of the drawing]

[0257] [Figure 1] An example of a prior art breathing mask is shown. [Figure 2a] An example of a respiratory humidification device used with a single limb breathing circuit is shown. [Figure 2b] A schematic diagram of a respiratory humidification device used in conjunction with two limb breathing circuits is shown. [Figure 3a] An example of a respiratory humidification device located between the endotracheal tube and the main breathing circuit is shown. [Figure 3b]An example of a respiratory humidification device positioned between a nasal pillow and a main breathing circuit is shown. [Figure 4a] An example of a moisture exchanger arranged perpendicular to the air flow is shown. [Figure 4b] A further example of a moisture exchanger arranged perpendicular to the air flow and a heating element are shown. [Figure 4c] An example of a moisture exchanger arranged at an angle to the air flow and a heating element are shown. [Figure 5a] Examples of moisture exchangers with a pleated or folded structure arranged in a straight line or parallel to the air flow are shown. [Figure 5b] Examples of moisture exchangers with a pleated or folded structure arranged in a straight line or parallel to the air flow are shown. [Figure 5c] Examples of moisture exchangers with a pleated or folded structure folded into a conical shape are shown. [Figure 6] A bias flow vent for a respiratory humidification device containing a bias flow guide and a bias flow baffle is shown. [Figure 7] An example of a respiratory humidification device with a removable module positioned between a full face mask and a single limb breathing circuit is shown. [Figure 8] Examples of removable modules made from two axial engagement parts, including a bacterial filter and / or a virus filter, and a plurality of bias vent outlets are shown. [Figure 9a] Examples of heaters and flow sensors for the removable module of FIG. 8 are shown. [Figure 9b] Examples of holding means for a moisture exchanger for use with the heater and flow sensor of FIG. 9b are shown. [Figure 10] Some examples of respiratory humidification devices with separate power supplies are shown. [Figure 11] Some examples of respiratory humidification devices with a wall-mounted power supply are shown. [Figure 12] An example of a user interface for a respiratory humidification device is shown. [Figure 13]This example shows a respiratory humidification device in which the controller is designed to suspend module connectors and removable modules for use with them. [Figure 14] An example of a respiratory humidification device is shown, in which the controller is installed on the patient's bed and designed to be used with a module connector and a removable module. [Figure 15] This example shows a respiratory humidification device that integrates a controller and module connector, and also features a touchscreen user interface. [Figure 16a] This shows an exploded view of the removable module. [Figure 16b] Figure 16a shows an example of the sensor arrangement inside the removable module. [Figure 16c] An example of a connection cable between a removable module and a controller is shown. [Figure 17a] Various embodiments of module connectors, including removable modules and sensors, are shown. [Figure 17b] Various embodiments of module connectors, including removable modules and sensors, are shown. [Figure 17c] Various embodiments of module connectors, including removable modules and sensors, are shown. [Figure 17d] Various embodiments of module connectors, including removable modules and sensors, are shown. [Figure 17e] Various embodiments of module connectors, including removable modules and sensors, are shown. [Figure 18] Figure 17a shows the respiratory humidification device, but it is missing one temperature sensor. [Figure 19] This shows a portion of an example of a respiratory humidification device with a removable module and electronics integrated into the module connector. [Figure 20] This shows the controller's memory selection table. [Figure 21]A flowchart of the algorithm for calibrating heater resistance is shown. [Figure 22a] This shows a respiratory humidification device used with a single limb breathing circuit and exhalation valve. [Figure 22b] This image shows a respiratory humidifier used with an endotracheal tube, accompanied by a single-limb breathing circuit and positive end-respiratory pressure (PEEP) clinical configuration. [Figure 22c] This image shows a respiratory humidifier used with a non-invasive ventilation (NIV) mask with a single-limb and exhalation valve breathing circuit. [Figure 22d] This image shows a respiratory humidification device used with a non-invasive ventilation (NIV) mask with a breathing circuit consisting of two limbs and a PEEP valve. [Figure 23a] This shows the typical airflow during breathing with prior art devices and the output of the corresponding controller. [Figure 23b] This shows a typical airflow during breathing with the respiratory humidification device of the present invention and the output of the corresponding controller. [Modes for carrying out the invention]

[0258] arrangement Overall placement & bias vents Respiratory humidification devices can be integrated into patient interfaces such as CPAP and non-invasive ventilation (NIV) masks, with the moisture exchanger located inside the mask or between the mask frame inlet and the main breathing circuit.

[0259] Many CPAP and non-invasive ventilation (NIV) patient interfaces have bias flow vents located on the mask frame or elbow. Exclusion It has an outlet (see Figure 1; the prior art Fisher & Paykel Simplus 1001 has a full face mask with bias flow vent holes located in the upper region of the mask frame above the elbow). The bias flow vent contains substantially all of the air the patient exhales. Airflow continuous Standardly or variably It is drained out of the breathing circuit.

[0260] In Figure 2a, the respiratory humidification device 2001 of the present invention, or a part of the present invention (e.g., a heater, a moisture exchanger, and / or a user interface), is preferably connected to the respiratory circuit between the air delivery tube and the patient interface. 、 Similar in size to prior art HME self-contained unit Placed inside It is shown that the respiratory humidifier device can also be incorporated into the breathing circuit, for example, as part of the main breathing tube, and therefore the respiratory humidifier device can be replaced as part of the breathing circuit.

[0261] Figure 2a shows a single-limb breathing circuit 2002. The bias flow vent is located upstream of the water exchanger or on the non-patient side (respiratory support device side). A patient interface (e.g., mask) (non-ventilated patient interface mask) without a bias flow vent on the frame or elbow should be used. Location selection All of the air exhaled (by the patient) Guide it to pass through the moisture exchanger. This enables the recovery of fluids from the patient.

[0262] Figure 2b shows a schematic diagram of the 2010 respiratory humidifier device used in a two-limb breathing circuit. In this case, since the ventilator (respiratory support device) receives exhaled air and either expels or recirculates it, there are no bias flow vents in the patient interface, respiratory humidifier device, or breathing circuit. The respiratory humidifier device is Y Near the contact point, the patient has a Y-contact that connects the inspiratory limb 2011, the expiratory limb 2012, and the patient interface 2013. side It will be located at the base. The respiratory humidifier device may further incorporate a Y-contact. In that case It may have two upstream connectors and one downstream connector.

[0263] Figures 3a and 3b also show schematic diagrams of a respiratory humidifier device 3001 used in a two-limb breathing circuit. This respiratory humidifier device includes a user interface including buttons and incorporates a battery (not shown) as a power source inside the device. The respiratory humidifier device 3001 may also include an extension tube that connects at the downstream end to an endotracheal tube (Figure 3a) or nasal pillow (Figure 3b) of the patient interface. Upstream, the breathing circuit may include inspiratory and expiratory limbs connected to the respiratory humidifier device via a Y-connector.

[0264] connector Masks designed without a bias flow vent on the patient side of the frame, elbow, or typically the respiratory humidifier device should have mechanical connections designed not to connect directly to a standard CPAP circuit, such as a 22mm tapered connector (or similar ISO standard connector). This prevents patients or healthcare providers from mistakenly connecting a standard CPAP breathing circuit directly to the mask without using a respiratory humidifier device. When you connect directly Because a bias flow vent will not be provided in the system (of a non-ventilating mask), it may pose a risk to the patient. Warnings, colors, and / or terminology may be placed on such masks to provide additional protection.

[0265] The connector on the non-patient side (upstream) of the respiratory humidifier device may be a standard ISO medical connector, such as a 22mm male or female tapered connector. This allows the respiratory humidifier device to be connected to a standard breathing circuit installed in a hospital or home. Two or more upstream connectors may be present.

[0266] The patient-side (downstream) of a respiratory humidifier device should preferably not have a standard detachable connector to avoid accidental connection of the humidifier device to a non-ventilating mask when the humidifier device is designed to be used with a non-ventilating mask. Alternatively, the downstream connector may be a standard connector, depending on the application.

[0267] Components Examples of suitable substrates include fibrous materials such as natural fibers (especially cotton, linen, chitin, or chitosan), synthetic or processed fibers (especially rayon, polyvinyl alcohol (PVA), or polypropylene (PP)), or mixtures thereof, and non-fibrous materials with a large amount of granular, crystalline, or porosity, such as certain manufactured metal or polymer structures, or naturally occurring metal or polymer structures. The substrates may have regular or irregular structures, or a combination of both, e.g., woven or nonwoven fabrics, three-dimensionally printed metal matrices, or sintered metal matrices. In some embodiments, the substrate may be a fibrous product, while in other embodiments, open-cell foam or other suitable materials may be used.

[0268] A necessary characteristic of a substrate suitable for use with the present invention is that it has a very large surface area relative to its volume, allowing air to pass through easily. Ideally, the substrate is porous, with a porosity exceeding 10% or 25%, more preferably exceeding 50% or 75%.

[0269] A temperature-responsive polymer may be a copolymer that can be grafted onto a substrate, a copolymer grafted from a substrate, a copolymer that can be polymerized to form a substrate, or a copolymer polymerized to form a substrate. The substrate and the temperature-responsive polymer may be the same, for example, a network polymer structure or copolymer structure, a network polymer structure made from one or more polymers or copolymers, an electrospun fiber, a woven fiber, or a nonwoven fiber.

[0270] Placement of moisture exchangers Respiratory humidification devices are airflow Inside to Placed A moisture exchanger will be necessary.

[0271] Figures 4a and 4b show a moisture exchanger 4001 mounted perpendicular to the airflow, so that all or substantially all of the airflow must pass through the moisture exchanger's substrate during exhalation or inhalation. The moisture exchanger is held in place by a first and a second clamping ring against a disc-shaped and substantially porous or open heater (shown schematically here). The raised edge of the second clamping ring secures the heater aligned with its central axis, and wires carry power from the controller to the heater. The moisture exchanger is cut into a disc shape, its shape concentrically conforming to the raised edge of the first clamping ring and securing the moisture exchanger aligned with its central axis. The moisture exchanger is, In order to improve the water retention and, consequently, the performance of respiratory humidification devices, The substrate and two or more layers of temperature-responsive polymer are That's fine.

[0272] Figure 4c shows a tubular removable module containing a moisture exchanger 4001 positioned at an angle to the axis of the tube. As a result, the moisture exchanger surface The product increases with respect to the cross-sectional area of ​​the removable module, and as the airflow passes from one end of the tube to the other, it traverses the moisture exchanger. edgeA larger moisture exchanger allows for greater moisture intake while creating a smaller pressure drop. A series of horizontal bar-shaped supports are positioned diagonally across the tube, and a cross-bent wire heater holds the moisture exchanger relative to the supports. The heater wire passes through the sides of the tube, making external contact. All airflow, during exhalation or inhalation, must pass through the moisture exchanger's substrate.

[0273] Pleated and foldable moisture exchangers Figures 5a and 5b show another tubular removable module 5001 containing a moisture exchanger with a pleated or folding structure that is parallel to the airflow but in contact with the airflow, thereby allowing the airflow to contact the moisture exchanger but not necessarily pass through the substrate during exhalation or inhalation. The removable module encloses a moisture exchanger of a first half-shell and a second half-shell, and these half-shells are held together around the moisture exchanger by a first clamping ring and a second clamping ring. Any other known method for joining the plastic housing (half-shells), such as adhesive, welding, or snap-fit ​​connections, may be used. The frame is formed from two parallel rings connected by several struts, around which the moisture exchanger folds, so that the moisture exchanger intersects the airflow path between the two rings. The moisture exchanger has a heater element woven in therein. During use, a removable module is installed in the respiratory airflow path, and as a result, the airflow passes through the centers of the first and second clamping rings and across the surface of the foldable moisture exchanger.

[0274] Figure 5c shows yet another tubular removable module 5001, one of which has a moisture exchanger folded into a cone shape, with the axis of the moisture exchanger coinciding with the axis of the tube. As a result, the cross-sectional area of ​​the moisture exchanger is increased relative to the cross-sectional area of ​​the removable module, allowing the larger moisture exchanger to take in more moisture while creating a smaller pressure drop across the moisture exchanger as airflow passes from one end of the tube to the other. A substantially open conical support is formed inside the tube, and a heater of cross-bent wire (or spiral) holds the moisture exchanger against this support. The heater wire passes through the side of the tube that it contacts on the outside. All airflow is exhaled or inhaled. to It needs to pass through the substrate of the moisture exchanger.

[0275] Integrated bias vent & design In some applications, for example, with CPAP, APAP, or BiPAP as shown in Figure 2a, it is preferable that the respiratory humidification device incorporates an integrated bias flow vent located upstream of the moisture exchanger, i.e., on the respiratory support device or non-patient side.

[0276] Bias flow vents can be integrated into respiratory humidification devices or removable module housings, may consist of one or more holes, and may also be covered with a diffuser or filter-like material to diffuse the airflow escaping outside the bias flow vent, thereby reducing patient discomfort.

[0277] Preferably, the bias flow vent is located near the moisture exchanger, preferably within 5 cm of the moisture exchanger, or more preferably within 3 cm, so that the air supplied by the respiratory support device reaches the bias flow vent before reaching the moisture exchanger. Placement It can be done.

[0278] Preferably, the bias flow vent is positioned such that a portion of the bias flow passing through it is directed toward a moisture exchanger to create a cooling flow, which cools the moisture exchanger during exhalation or at the end of inspiration. The cooling flow may be a turbulent vortex of bias flow created by the bias flow exiting the bias flow vent, or the cooling flow may be the bias flow itself directed parallel to the surface of the moisture exchanger by the relative arrangement of the respiratory support device and the upstream connector supplying air from the bias flow vent. Thus, a bias flow guide may be present within the respiratory humidifier device to direct the cooling flow toward the moisture exchanger.

[0279] The cooling flow is strong enough to effectively pass through the moisture exchanger. That should not happen. The reason for this is that doing so would cool the walls of the device downstream of the moisture exchanger (towards the patient), and consequently cause condensation. Also, to prevent the cooling flow from cooling, a bias flow baffle may be present on the opposite side of the moisture exchanger from the bias flow vent. Preferably, the bias flow vent is at least 1 cm, and preferably at least 2 cm, from the moisture exchanger. Distant .

[0280] Figure 6 shows an example of a partial embodiment of the respiratory humidifier device 6001 with radially arranged bias flow vents. Figure 8 also shows the bias flow guide and bias flow baffle. The change in the direction of the bias flow exiting the respiratory humidifier device through the bias flow vents creates a vortex in the area of ​​the moisture exchanger, which serves to cool the moisture exchanger. point To enhance the cooling effect of these vortices, bias flow guides and bias flow baffles are further provided to reduce the intrusion of vortices through moisture exchangers that would cool downstream components and cause undesirable condensation.

[0281] Removable module Figure 7 shows a respiratory humidification device 7001, in which the moisture exchanger and heater are contained within a removable module 7002 that can be removed from and replaced from the breathing circuit when necessary. Figure 7 shows a removable module for a single-limb breathing circuit, using a full-face mask, and the removable module is also useful for dual-limb breathing circuits and other patient interfaces such as nasal pillow masks and endotracheal tubes.

[0282] The removable module comprises a moisture exchanger as shown in Figure 4 and a heater concentrically held inside a circular housing. The upstream and downstream tubes are housed in the housing. inside The moisture exchanger and heater are rotatably latched, holding them in place and ensuring they are in firm axial contact with each other. The moisture exchanger shown in Figure 5 can also be used with a removable module.

[0283] The upstream tube contains two wires that transport power from the controller to the heater. The heater is held in contact with the two wires by rotatably latching the upstream and downstream tubes to the housing at a predetermined rotation relative to the housing and the upstream tube, as determined by the design of the tube and the housing, and is positioned to ensure that the heater is powered by the two wires coming from the upstream tube.

[0284] The upstream tube is connected to a respiratory support device, and the two wires are connected via connectors to the controller of a respiratory humidifier device, allowing the controller to heat the moisture exchanger. The wires may be formed on the upstream tube, or they may be detachably clipped to the upstream tube, or the wires may take a completely separate route.

[0285] During use, the removable module twists. operationIt can be separated by a mechanism that allows for the replacement of the moisture exchanger and / or heater. Additionally, the removable module can be replaced at different times for the upstream or downstream tube.

[0286] In an alternative embodiment, the housing is part of the upstream tube, the heater is fixed to the housing, and only the moisture exchanger is removable.

[0287] Electronic controller As shown in Figures 3a and 3b, the controller, sensors, and power supply of the respiratory humidification device can all be located within a single housing that also contains the moisture exchanger and heater. Alternatively, some or all of these functions may be located distal to the moisture exchanger, with wires(s) delivering power from the distal controller to the heater, as shown in Figure 7.

[0288] For example, in Figure 7, the prior art respiratory support device may already have a flow sensor, a microcontroller, and a power supply. These functions can be provided by the respiratory support device to the respiratory humidification device, which measures the patient's respiratory flow rate, transmits a signal to the respiratory humidification device controller, determines when power needs to be supplied to the heater, and supplies power to the heater via two wires. The controller for the respiratory humidification device may be implemented in the controller for the respiratory support device, and the two devices may be integrated into a single unit.

[0289] The wire may be retained in the breathing circuit, mechanically clipped to the outside of the breathing circuit, or fixed in place. Alternatively, the wire may be located inside the breathing circuit or incorporated into the wall of the breathing circuit, as is the case with most heated wall respiratory support device tubing, as shown in Figure 7. By connecting the breathing circuit (at the other end) to the respiratory support device and respiratory humidification device, a connection for an electrical circuit may also be formed to power the respiratory humidification device, or otherwise to communicate with the respiratory humidification device electrically / electronically.

[0290] The signal is also Bluetooth (Registered trademark) ,Wifi (Registered trademark) Alternatively, it may be transmitted between the respiratory humidification device housing and the respiratory support device via wireless technology such as electromagnetic induction power transmission via communication.

[0291] Bacteria / Virus Filter Respiratory humidification devices, specifically removable modules, may have no filters in the inspiratory or expiratory flow path, and may include one or more integrated bacterial / viral filters. If the respiratory device has no integrated filters, it may be used with the primary breathing circuit to filter the inspiratory or expiratory flow, or both.

[0292] Figure 8 shows a removable module 8001 that includes an integrated bacterial and / or viral filter located between the moisture exchanger and the non-patient device outlet. This removable module further includes numerous axially oriented holes around the circumference of the upstream connector. as Includes positioned bias flow vents. A ring-shaped diffuser surrounds the upstream connector and covers the bias flow vent hole, which is generated by air escaping through the hole. ru Reduce noise.

[0293] The removable module 8001 in Figure 8 further includes a support structure containing a heater and a sensor in the airflow path (described below with reference to Figure 9), and a downstream connector for connection to the patient interface. The moisture exchanger is held in axial engagement with the heater by an upstream and downstream section held together by screws. The removable module includes a connector (not shown) for a cable to a controller, which supplies power to the heater and reads signals from the sensor.

[0294] Furthermore, if the bias flow vent is integrated and exhalation filtering is required, one or more filters should be located between the moisture exchanger and one of the bias flow outlet vents.

[0295] The filter embodiment includes one or more to address the functions described above. Individual It may include a filter. The filter material is directional. In the case The more hydrophobic filtering surface should face the moisture exchanger for each filter. Embodiments of bacterial / viral filter(s) and filter holder design teeth This should ensure that all airflow in the required filtering direction passes through the filter.

[0296] Respiratory humidifiers may be used in combination with respiratory system filters, such as pleated hydrophobic or electrostatic filters, installed upstream of the moisture exchanger, to provide filtering of bacteria and viruses (>99%) and to offer additional protection to the patient.

[0297] heater resistance The heater preferably includes a resistance heater that is in thermal contact (preferably direct thermal contact) with the moisture exchanger. Examples of resistance heaters include wires or conductive polymer filaments sewn into or woven into the moisture exchanger, or said filaments pressed in contact with the moisture exchanger, or flexible printed circuits bonded to or otherwise pressed against the moisture exchanger. Exemplary heater and moisture exchanger arrangements are described below.

[0298] Figure 9a shows the resistive heating element 9001, and the resistive heating element 9001 is located in the hole of the support structure I was led insideIt can be used with the removable module described with reference to Figure 8. The resistance heating element is wound to provide even heat distribution throughout the moisture exchanger. The hole pattern and surrounding support structure are positioned within the radius of the flow path to maximize the exposure of the resistance heater element to the airflow and improve cooling. The support space for the heater element is set to exceed the minimum safety clearance to avoid electrical arcs and short circuits. The hole arrangement is threaded for multiple heater elements. re This allows for the use of patterns and heater elements that are both flexible and self-supporting. re Using this arrangement, the length of the heater element in direct contact with the moisture exchanger and the length in direct contact with the fresh air inlet can be increased or decreased. Instead of holes such as slots formed on the outside of the support structure, alternatives can be used, allowing the heating element to be wound around the support structure and improving manufacturability. Winding the heating element around vertical posts is yet another alternative option.

[0299] Figure 9b shows the proximity of the moisture exchanger 9005 to the heater 9010, which is positioned next to the moisture exchanger retaining ring. The tension on the moisture exchanger is set by the clearance between the retaining ring and the support structure. During inhalation, the moisture exchanger is pulled against the heater element, ensuring maximum heat transfer. During exhalation, the clearance between the retaining ring crossbar and the heating element may reduce contact between the moisture exchanger and the heater element, potentially improving cooling.

[0300] infrared In some embodiments, the heater may be an infrared heater. Infrared heaters offer several advantages. For example, infrared heaters can be turned on and / or off almost instantaneously (with less time lag than wire heater elements). Infrared heaters can be hygienically isolated from the moisture exchanger and the inspiratory and expiratory airflow paths. This can reduce operating costs. This is because the infrared heat source may be reusable between the same patient or between other patients. The infrared heat source, together with the controller, may be sealed in a glass or plastic housing, or otherwise isolated from the airflow by a light-transmitting or light-refracting material.

[0301] Any reflected infrared light may also be detected by an optical sensor to calculate the humidity level of the air passing through the device (air inhaled and / or exhaled by the patient), or the amount of moisture taken in by the moisture exchanger.

[0302] Plurality To deliver different temperature profiles to different locations in a respiratory humidifier or different areas of a moisture exchanger, there may be two or more heaters that can be controlled together or independently.

[0303] Figure 9a shows the support structure inside the removable module of the respiratory humidification device. The support structure incorporates multiple first and second heaters. In this example, the first and second heaters are held in place by the retaining structure. Through construction Formed from a single continuous element of wire and controlled together by a controller, the multiple first heaters are in contact with both the moisture exchanger and the airflow, while the multiple second heaters are not in contact with the moisture exchanger but are still in contact with the airflow. (Figure 9b shows the location of the moisture exchanger relative to the support structure.)

[0304] In low-temperature room conditions, a respiratory humidifier with only a first heater may not allow the moisture exchanger or heater to cool quickly enough to capture substantially all of the moisture exhaled by the patient. Therefore, a second heater, not in contact with the moisture exchanger, can cool more quickly. Furthermore, during inhalation, the second heater can transfer more thermal energy to the inhaled air before it reaches the moisture exchanger. With only a first heater, it can inevitably become so hot that it would damage the moisture exchanger. Therefore, having two heaters provides better control over humidification performance and greater comfort to the user.

[0305] Various combinations of heaters and their locations (e.g., upstream or downstream of the moisture exchanger) are possible. Multiple heaters may also be used, and these heaters may be controlled separately or together by the controller.

[0306] Power supply and battery Figure 10 shows a power supply 10001, which includes a separate plug and AC / DC adapter (Figure 10a) that supplies power to the controller itself, a separate battery pack connected in parallel or directly to the controller (Figure 10b), or a battery integrated into or removable from the controller housing 10002 to form a coupling unit (Figure 10c).

[0307] Figure 11 shows an integrated wall power plug and AC / DC adapter supplying power to the controller itself 11001 (Figure 11a), and also shows a separate battery pack connected in parallel with the integrated wall power plug as an alternative power source for controller 11002 (Figure 11b), a separate battery pack connected in series with the integrated wall power plug as an alternative power source for controller 11003 (Figure 11c), or a battery integrated into or removable from the controller housing to form a coupling unit 11004 (Figure 11d).

[0308] User Interface - Reason for Existence A respiratory humidifier may include a user interface for turning the device on and off, changing humidification performance, canceling alarms, or checking the operation of the respiratory humidifier. To achieve these goals, the user interface may allow changing parameters related to the desired inspiratory flow. These parameters allow determining, by lookup table or calculation, the target point or target temperature used to control the timing and magnitude applied to the power heater.

[0309] User Interface - Features Figure 12 shows an example of user interface 12001, which is integrated into a respiratory humidification device and has an upstream connector for connecting to a respiratory support device and a downstream connector for connecting to a patient interface. The user interface includes four LED indicators, each next to one of four different humidity targets. Patients using nasal CPAP ventilation may require a relatively low level of humidification (25 mg / L). Patients using full-face bilevel ventilation may require a higher level of humidification (30 mg / L). Patients who have undergone tracheostomy may require 35 mg / L. Intubated patients may require a relatively high level of humidification (40 mg / L or higher). When the button is pressed... ,Ko Timing used by the controller , target point, and target temperature By changing the humidity target, four different humidity targets can be selected. They will switch sequentially. Press and hold the button to switch the respiratory humidification device on and off.

[0310] In alternative embodiments, the button may select a nasal, full-face, or intubation / tracheostomy option, or the knob may select humidity or temperature within a range of 20 mg / L to 40 mg / L or more. PossibleThe user interface may include the selection and / or display of multiple parameters, such as independently setting / displaying temperature, humidity, and / or absolute or relative humidity.

[0311] The user interface may include both an indication of the selected setting and an indication of the level of performance achieved, such as intake airflow humidity or temperature. For example, a red LED indicator may indicate that a setting has been selected but not yet achieved, and a green LED indicator may indicate that the selected humidification level has been delivered.

[0312] Furthermore, the user interface incorporates sound and / or light, for example, delivered ru Excessive mask leakage, which can reduce humidification levels, may trigger an alarm indicating that the respiratory humidification device is experiencing an error condition.

[0313] A respiratory humidification device may include controls for calibrating the respiratory humidification device or its sensors, changing the function or operation of status lights or alarms, or connecting or disconnecting a remote management device. Some controls may have multiple functions.

[0314] The respiratory humidification device may incorporate status indicators such as a graphical display, numerical readout, light, and a speaker or electronic sound generator, which may indicate the device's function (mode or setpoint, etc.), battery charge status, accurate operating status, error status, the need to change any consumable elements or removable modules, or connection to or disconnection from a remote management device. The user interface may also allow the user to set a series of changes to the respiratory humidification device's humidification and / or temperature performance over time, for example, 20 mg / L humidity for 1 hour, 25 mg / L for 4 hours, etc. The user interface may also display recorded data regarding the respiratory humidification device's performance, or allow use over periods such as less than 24 hours, 24 hours, or longer than 24 hours.

[0315] Remote Management A respiratory humidification device may have a remote management interface that allows a remote management device to configure the respiratory humidification device.

[0316] The remote management device preferably uses a remote management interface to access the user interface and implement all the functions described above. The remote management device also preferably retrieves data from the respiratory humidifier. This data may include, for example, usage time and usage amount, inspiratory and expiratory flow parameters measured by sensors or otherwise estimated, the occurrence or frequency of sleep apnea, respiratory failure, dyspnea, etc., the need for or action regarding component replacement, or error conditions.

[0317] The remote management interface uses wireless communication (e.g., cellular networks, wide area networks, e.g., LoRaWAN). (Registered trademark) Sigfox (Registered trademark) Bluetooth (Registered trademark) ,Wifi (Registered trademark) Zigbee (Registered trademark) Z-Wave (Registered trademark) This may include one or more of the following: NFC, or wired communication (e.g., USB, I2C, SPI, RS-232, RS-485).

[0318] The remote management device may be a respiratory support device, a mobile phone, a tablet computer, a computer server, or an internet cloud service. The remote management device may be an artificial intelligence remote management device, which is capable of retrieving data from the respiratory humidification device and, based on that data, performing actions including configuring the respiratory humidification device and alerting the human user or patient.

[0319] User Interface - Layout Figures 13 and 14 show exemplary respiratory humidification devices (13001 and 14001), where the detachable module is separated from the controller by a cable, and the cable terminates with a module connector specifically designed to connect to the detachable module.

[0320] Figure 13 shows a controller that can be suspended from an IV pole or mounted on a ventilator or other device, and the controller may include any combination of the examples described above. The controller includes + and - buttons for changing humidification settings and an LCD screen for displaying current performance and any error messages. The controller is connected to a module connector via a control cable.

[0321] Figure 14 shows a controller positioned in a line with respect to the control cable, or with the control cable suspended from it, and the controller may include any combination of the examples described above. The controller includes + and - buttons for changing the humidification setting, and an LCD screen for displaying the current performance and any error messages. The controller is connected to the module connector via the control cable.

[0322] Figure 15 shows another example of the respiratory humidification device 15001 in which the controller is integrated into a module connector. The controller includes a touchscreen user interface, which is molded onto the cable with a module connector and a direction indicator (indicated in the example by the pointed shape of the module connector).

[0323] In Figures 13, 14, and 15, the controller is connected to a power source by a power cable, and the module connector and removable module can be separated to replace the removable module.

[0324] The user interface and controller do not need to reside in the same unit. For example, the controller can be installed in a module connector, and the user interface can be installed in a separate unit. In such embodiments, it would be impossible to distinguish between Figure 13 and Figure 14 from the outside.

[0325] Machine controller Rather than using an electronic controller to determine when to supply power to the heater, the controller may be a mechanical switch used to control the power to the heater. For example, the mechanical switch may be located within the airflow path. The switch may be switched on and off by a change in the direction of the patient's breath. When the patient inhales the flow, the flow switch may be switched on, supplying power to the heater. When the patient exhales, the flow switch may be switched off, removing power from the heater and thus mechanically controlling the power supplied to the heater.

[0326] The mechanical flow switch is preferably biased on or off by, for example, a spring, magnet, or other system. For example, if the flow switch is biased on, and the patient is approaching the end of their expiratory cycle, the bias of the flow switch changes the switch to the ON state, thereby supplying power to the heater, allowing time for the heater to heat up and providing heat to the moisture exchanger to initiate the inspiratory part of the respiratory cycle. Alternatively, if the flow switch is biased off, and the patient is approaching the end of their inspiratory cycle, the bias of the flow switch changes the switch to the OFF state, thereby removing power from the heater, allowing time for the moisture exchanger to cool before initiating the expiratory part of the respiratory cycle. This bias may be adjustable by the user to deliver different levels of humidity and / or temperature.

[0327] Removable module sensor Figure 16a shows a removable module 16001, which contains all the components of the respiratory humidification device that come into contact with the inspiratory or expiratory flow. Figure 16b shows details of the support structure 16002 for the heater and sensor in Figure 16a. In this example, there are no parts of the respiratory humidification device other than the removable module that come into contact with the inspiratory or expiratory flow. The controller, power supply, and module connectors will not come into contact with the exhaled breath or body fluids of any patient.

[0328] The removable modules in Figures 16a and 16b have three separate sensors.

[0329] Firstly, there is an SHT30 temperature and humidity sensor located in the support structure, and airflow on the patient side Inside It is installed in the downstream temperature sensor. The SHT temperature and humidity sensor is sufficiently isolated from the other components. They are far apart For example, as part of the operation of a flow sensor, it helps to avoid interference with readings from emitted heat.

[0330] Secondly, the flow sensor (item 9 in Figure 16a) comprises a resistive heater (item 4 in Figure 16b) of one thermistor (item 5 in Figure 16b) located upstream on the central flow axis, and one thermistor (item 3 in Figure 16b) located downstream. Each of these thermistors has a thin bridge with a narrow gap between the bridges. above It is located in a gap, bridge. interval The bridge width is sufficient to avoid the transfer of conductive and radiant heat between the resistive heater element and the sensor. of Read the convection heat from the thermal resistor. Therefore , The comparison of readings from the two sensors is as follows: This indicates a change in the direction of flow.

[0331] Thirdly, the thermistor acting as the temperature sensor for the moisture exchanger (item 6 in Figure 16b) is located on the moisture exchanger side of the support structure. The sensor is in contact with the moisture exchanger, but there is a gap between the main sensor body and the support structure to maximize the thermistor's response to changes in the moisture exchanger's temperature. The thermistor is positioned 1-2 cm axially from the thermal resistor of the flow sensor to avoid significant interference with temperature readings.

[0332] Furthermore, the removable module in Figure 16a also includes a heating element of the same design as that described with reference to Figure 9.

[0333] This sensor and heater combination includes a connection point for the module connector, which in this case is a reversible connector integrated into the module. Figure 16c shows cable 16010, which includes a module connector connecting the detachable module to the controller.

[0334] Sensors in module connectors Figure 17a shows an example of a removable module 17001 and module connector 17005, in which the module connector includes two conical temperature probes (sensors). By sealing the temperature probes and module connector, they can be immersed in a sterilizing fluid or sterilized in a steam environment.

[0335] One probe is an upstream temperature sensor, and the other is a downstream temperature sensor. The removable module includes two slightly tapered tubes to receive the two probes, with an upstream end and a downstream end. The module connector includes alignment wings shaped into an arc to partially enclose the outside of the removable module. By being closer to one probe than the other, and by tapering to a smaller diameter on the upstream side of each arc, the wings make it impossible to install the removable module incorrectly. The control cable connects to the non-patient side of the module connector and goes to the controller or power supply.

[0336] Figure 17b shows in detail that the probe 17015, with a temperature sensing tip at the bottom, has a substantially upper cylindrical region.

[0337] Figure 17c shows how the two parts of Figure 17a are connected, with the probe passing through the tapered tube into the removable module and being in the airflow. The substantially upper cylindrical region forms an interlocking fit with the tapered tubes of the two temperature probes, holding the two components of the respiratory humidifier device together firmly, despite the airflow and pressure being inside the removable module.

[0338] Figure 17d shows how the heater and moisture exchanger 17020 are sandwiched together between the upstream and downstream sections of a removable module, which is held in place by substantially two open grilles held between the upstream and downstream sections. The upstream and downstream sections are permanently welded together and sealed during manufacturing, for example, using ultrasonic welding. In some embodiments, the grilles may be formed as features of the upstream and downstream sections.

[0339] Figure 17e shows the alignment wing 17030, which, when installed, partially encloses the removable module and maintains the removable module and module connector in a properly aligned state. Each alignment wing includes an internal spring clip connector, which is electrically connected to the control cable. The heater electrical connection is welded between the upstream and downstream ends and passes through the opposite wall of the removable module to the contacts held on the outside of the removable module. When the removable module and module connector are properly installed, the spring clip connectors on the wings make contact with the contacts. During installation, the spring clip connectors pass over retaining ridges on the outside of the removable module, securely locking the removable module and module connector together.

[0340] Figure 18 shows an example of module 18001 with a single sensor probe 18020. The single-probe sensor arrangement is similar to the dual-probe arrangement in Figure 17, but with only one probe located on the patient side, and the corresponding single tapered crimp tube located on the detachable module.

[0341] The removable modules in Figures 17 and 18 may have integrated bias flow vents and bacterial / viral filters.

[0342] Removable module electronics Figure 19 shows a simplified cross-section of a removable module 19001 and module connector 19010, in which the controller is integrated into the module connector. The controller comprises a PCB with an FET switch for controlling power to the heater, a button for receiving commands from the user, two LEDs for informing the user of the status, and an electrical connector for power, as well as for informing the status and receiving commands from another device such as a remote user interface. The plastic housing is overmolded over the module connector PCB and components but thin in place, so that the LEDs can light up to warn the user of any problems, and the button can be pressed to select different operating modes such as invasive and non-invasive ventilation.

[0343] The controller also includes an upstream ultrasonic transducer and a downstream ultrasonic transducer, which, when the module connector is attached to the removable module, fit onto projections of the flow sensor on the wall of the removable module and transmit ultrasonic signals alternately between them. During use, the controller uses the difference in the time of flight of the sound traveling upstream and downstream of the airflow to determine when the patient is inhaling or exhaling. The projections protect the transducers from contact with the airflow.

[0344] Furthermore, the heater includes contacts on the outer wall of a removable module that engage with conductive pads on the PCB that protrude through the plastic housing.

[0345] Finally, an infrared (IR) sensor receives light from the heater and moisture exchanger through the wall of the removable module, and once calibrated, allows the controller to measure the moisture exchanger and heater temperatures. Alternatively, the resistance of the heating element can be measured to estimate the heater and moisture exchanger temperatures.

[0346] Therefore, the absence of a controller part that comes into contact with the airflow improves the hygiene of the respiratory humidification device.

[0347] Automatic mode selection As illustrated with reference to Figures 12, 13, or 14, the user may select one of several modes using the user interface. In alternative embodiments, two or more removable modules with specifications suitable for different uses, such as invasive and non-invasive ventilation, may be manufactured.

[0348] Figure 20 shows an exemplary controller memory selection table 20001. The controller measures the resistance of the heater of the removable module, searches for the corresponding row in the selection table, and, based on the selection table, determines which mode to operate. The controller controls the temperature of the intake airflow to match the target T value and also sets the color of the LED indicator to the corresponding color to indicate the selected mode to the user.

[0349] Instead of measuring resistance, an alternative embodiment includes a module connector having three contacts for connecting to a heater element, and a controller that detects which type of removable module is connected based on the combination of contacts connected to form a circuit. In yet another alternative, the controller may be capable of measuring the presence, absence, or characteristics of physical features specific to each type of removable module, such as colored patches on the removable module.

[0350] In this way, users do not need to change any user interface settings to select a mode; they can easily choose a removable module that is appropriately categorized or color-coded for their intended use, and the respiratory humidifier device will then properly configure itself. LED indicators may, for example, match the colors printed on the removable modules, easily ensuring that the respiratory humidifier device is correctly configured.

[0351] calibration Due to manufacturing tolerances, each removable module may differ slightly from the others. Therefore, the controller may need to be calibrated to match each individual removable module.

[0352] Figure 21 shows a flowchart of algorithm 21001 for calibrating heater resistances that may vary, for example, by + / - 5% between multiple modules. In step 2001, the controller determines whether a module is connected. It then measures the heater resistance (2002), calculates the ideal operating voltage according to a predetermined equation or lookup table (2003), and sets the heater supply voltage appropriately (2004). Next, it starts operating the respiratory humidification device by turning the heater on and off (2005) until it detects that a removable module has been disconnected (2006).

[0353] A similar calibration process for the controller may be necessary for any sensor on the removable module.

[0354] Purpose Respiratory humidification devices can be used in conjunction with respiratory support devices, for example, with anesthesia administration, tracheostomy, CPAP devices, Bi-level PAP devices, and with home or hospital ventilators, including heated humidifiers, non-heated humidifiers, and / or HMEs.

[0355] Furthermore, the respiratory humidifier may also be used in other applications where the patient is in perfect health, such as personal protective masks for general pollution, industrial pollution, and other dry environments such as aircraft or desert or high-altitude environments, or any part of the real world where people or animals are exposed to dry air, especially cold, dry air. In such cases, the system may need to be switched off from battery or non-mains power supply operation.

[0356] Exemplary Clinical Setting Figures 22a and 22b show a respiratory humidification device 22001 used in invasive ventilation with an endotracheal or tracheostomy tube. Both figures show exemplary embodiments provided in Figure 16, with a controller and power supply mounted near the ventilator as shown in Figure 10a. In Figure 22a, the removable module connects to the exhalation valve, single-limb breathing tube, and ventilator. In Figure 22b, the removable module connects to the inspiratory and expiratory limbs of a dual-limb breathing circuit, a PEEP valve, and the ventilator.

[0357] Figures 22c and 22d show respiratory humidification devices used in non-invasive ventilation, along with non-ventilating masks. Both figures show exemplary embodiments provided in Figure 16, with a controller and power supply located near the ventilator as shown in Figure 10a. In Figure 22c, the detachable module connects to an exhalation valve, a single limb tube, and a CPAP, APAP, or BiPAP respiratory support device. In Figure 22d, the detachable module connects to the inspiratory and expiratory limbs of a dual-limb breathing circuit, a PEEP valve, and a ventilator.

[0358] combination of respiratory humidification devices and other devices Respiratory humidification devices can be used in combination with water humidifiers, which are combined to provide higher humidification performance, different humidity profiles, maximize the performance of one by using the other, control droplet condensation on the patient interface and / or tubing, provide more precise temperature control, or provide more precise humidity control.

[0359] The respiratory humidifier is used in combination with a liquid water tank and can release liquid water droplets during exhalation by filling the water exchanger with liquid water droplets during inhalation and increasing the temperature of the water exchanger to approximately 80°C, thereby evaporating the liquid water.

[0360] control Predicting changes in power As disclosed above, it is desirable that the moisture exchanger be heated not only during the inspiratory phase but also before the start of inspiration (and before any sensor(s) detect the start of inspiration), and that power (and heat) be removed not only during the expiratory phase but also before the start of exhalation (and before any sensor(s) detect the start of exhalation), or at least that the controller apply power to provide a useful option for the public.

[0361] Figure 23a shows the behavior of the prior art controller described in International Publication No. 2019 / 093910. When the black line 23001 is above the dashed line 23002, the flow is inhalation, and when the black line is below the dashed line, the flow is exhalation. When the flow is inhalation, the heater power (red line) 23003 switch is turned on, and when the flow is exhalation, the heater power switch is turned off.

[0362] Figure 23b shows the behavior in one embodiment of the present invention, where the controller increases the heater power (turns on the heater switch) before the respiratory flow rate changes from exhalation to exhalation, and decreases the heater power (turns off the heater switch) before the respiratory flow rate changes from exhalation to exhalation.

[0363] In this embodiment, the controller reduces heater power (switches off the heater) before the respiratory flow rate changes from inspiration to expiration. Preferably, this is done so that the temperature of the moisture exchanger drops to or below a second target temperature before expiration begins, or at least before expiration reaches a significant portion of the peak flow rate or total volume, for example, before reaching 5%, 10%, 20%, or even 30% of the peak flow rate or total volume. Preferably, the second target temperature is the LCST, or even 0.5°C or 1°C lower than the LCST.

[0364] Preferably, this is done so that the temperature of the moisture exchanger rises to or exceeds a first target temperature before inspiration begins, or at least before inspiration reaches a substantial portion of the peak flow rate or total volume, for example, before it reaches 5%, 10%, 20%, or even more preferably 30% of the peak flow rate or total volume. Preferably, the controller also controls (limits) the heater power (or keeps the heater off until closer to the start of inspiration) so that, as a result, the temperature of the moisture exchanger does not reach or exceed an undesirable temperature before the end of exhalation, or before a large portion of the exhaled volume (preferably 70% or 80% of the exhaled volume, or more preferably 90% of the exhaled volume) passes through the moisture exchanger, or before the exhaled flow rate drops significantly (preferably before it falls below 30% or 20% of the peak exhaled flow rate, or more preferably before it falls below 10% of the peak exhaled flow rate). Preferably, the desired or undesirable temperature is LCST, or more preferably, those temperatures are 0.5°C or 1°C higher than LCST and lower than LCST, respectively.

[0365] Flow detection The controller may use any of the commercially available, known flow sensors to detect the magnitude or direction of the respiratory airflow.

[0366] Regarding control timing Key Features To determine when to change the heater power, the controller senses the parameters measured regarding the airflow through the moisture exchanger and uses the measured parameters to determine one or more in the respiratory cycle. Key Features This can be detected. Preferably, the measured parameters are the velocity and direction of the airflow, however, in some alternative embodiments, the parameters may be, for example, the airflow pressure.

[0367] Ideally, one or more Key FeaturesThis includes the transition from inspiration to expiration and / or vice versa, or similarly, the start / end of expiration or inspiration. The start and / or end of inspiration and expiration can be detected by calculating the timing of the transition of the measured parameter from a value above a threshold to a value below a threshold, or from a value below a threshold to a value above a threshold.

[0368] When the measured parameter is airflow, the threshold can be zero, and especially if the airflow sensor provides direction, it can easily detect the start or end of exhalation. However, many cost-effective sensors do not provide airflow or airflow direction. And even when the sensor provides airflow and direction, given the various ambient conditions under which the respiratory humidification device must operate, specifically the possibility of leak error conditions in the patient interface, in some embodiments, the threshold is determined by calculating the average value of the parameter measured over the preceding period, including multiple respiratory cycles, e.g., 30s or 60s. Then, the threshold can be the average value of the measured parameter, or the threshold can be set to a predetermined amount above or below the average, or a proportional amount above or below the average compared to the maximum or minimum value of the parameter measured over the preceding period, including multiple respiratory cycles. As a specific example, the measured parameters (including the direction of airflow) could be the airflow through the moisture exchanger, and the predictive controller could calculate the average value of the airflow. When the airflow exceeds the average value, it detects the approximate start of inspiration, and when the airflow falls below the average value, it detects the start of exhalation.

[0369] In other embodiments, one or more individual points may be determined by the rate of change of a measured parameter, whether it is above or below a threshold.

[0370] Key Features Use of time offset from To achieve the desired feature of changing heater power before the start of inhalation or exhalation, the controller may be a predictive controller, and continuous inhalation or exhalation cycles or Key Features It monitors and learns the typical duration of those cycles, or the respiratory cycle duration as a whole. By knowing those durations, the predictive controller learns more about the respiratory cycle. Key Features The heater power can be changed with a time offset after one of these cycles, which is done on the expectation that the power will be a known quantity before the subsequent cycle.

[0371] In a preferred embodiment, the time offset is proportional to the respiratory cycle duration. The respiratory cycle duration is as described above. Key Features It can be calculated from the average elapsed time between one or more of the following points.

[0372] Multiple time offsets Furthermore, different respiratory cycles Key Features And / or with respect to different changes in the power supply, there may be multiple time offsets.

[0373] multiple Key Features The start of inspiration and the start of expiration can be the time offsets, and thus multiple time offsets include an inspiratory time offset and an expiratory time offset. The inspiratory time offset is a time offset after the change in respiratory flow rate from expiration to inspiration. In one embodiment, the controller reduces the heater power (or switches off the heater) at the time of the inspiratory time offset after the change in respiratory flow rate from expiration to inspiration. The expiratory time offset is a time offset after the change in respiratory flow rate from inspiration to expiration. The controller increases the heater power (or switches on the heater) at the time of the expiratory time offset after the change in respiratory flow rate from inspiration to expiration.

[0374] The time offset, inspiratory time offset, or expiratory time offset is preferably shorter than the inspiratory or expiratory period, or shorter than the sum of the inspiratory or expiratory periods. These time offsets are preferably less than 75% of the inspiratory or expiratory period, more preferably less than 50%, and even more preferably less than 33%.

[0375] The minimum time offset options are, for example, 1s, 1.5s, or 1s-3s.

[0376] Static time offset In one embodiment, the time offset can be determined in advance based on one or more of the following: the time constant of the heater, the rate of heat transfer into the moisture exchanger, the response rate of the moisture exchanger to temperature changes, and the rate of absorption or desorption of moisture from the moisture exchanger.

[0377] Dynamic time offset The time offset may be a dynamic time offset that changes over time. The dynamic time offset can be determined using one or more of the following: the respiratory cycle duration, the temperature and humidity of the desired or actual inspiratory flow, the humidity, temperature, or flow rate of the expiratory flow, and the temperature or humidity of the ambient air or supplied airflow.

[0378] In some embodiments, an increase in the desired intake airflow temperature or humidity results in a smaller dynamic time offset; that is, the controller causes the power supplied to the heating element to change more rapidly. Conversely, a decrease in the desired intake airflow temperature or humidity results in a larger dynamic time offset; that is, the controller causes the power supplied to the heating element to change more slowly.

[0379] Phase-locked loop for control timing Another way to achieve the desired feature of changing heater power before the start of inspiration or expiration is to use a phase- and frequency-locked loop (PLL) that is synchronized with the respiratory cycle and driven by measured parameters. The phase output of the PLL is used to determine whether to turn the heater on or off. The controller may turn the heater on and off at a phase predetermined or calculated relative to the respiratory cycle (PLL estimation of the respiratory cycle). The controller may also change the target temperature at a phase predetermined or calculated relative to the respiratory cycle (PLL estimation of the respiratory cycle).

[0380] Flow threshold for control timing Alternatively, if the airflow velocity falls below a threshold, the controller may apply heat. For example, heat may be applied if the expiratory flow velocity falls below 40% of the peak expiratory flow or the average flow rate. This percentage is an example, and in practice, other flow thresholds such as 20%, 30%, or 50% may be applied. This ensures that the heat source has time to provide heat to the moisture exchanger and warm it up. This is a useful method because the flow rate tends to be relatively low for a long period of time at the end of the expiratory cycle.

[0381] An alternative could be a tidal volume threshold, where a sensor, such as a flow sensor, is used to calculate a typical tidal volume, and heating occurs when the exhaled tidal volume is reached, for example, 80% of the average tidal volume. This percentage is an example, and in practice, other tidal volume thresholds such as 40-80%, 80-90%, or 90-99% may be applied.

[0382] The same trigger can be applied to the inspiratory cycle, and heating stops after the inspiratory flow falls below a threshold or after the inhaled tidal volume exceeds a certain threshold. For example, heating may stop when the inspiratory flow rate falls below 40% of the peak flow or the average flow, or when the inhaled tidal volume exceeds 80% of the expected tidal volume. This percentage is an example, and in practice, other flow (or tidal volume) thresholds such as 20%, 30%, or 50% (or 40-80%, 80-90%, or 90-99%) may be applied. This ensures that the heat source has time to provide heat to the moisture exchanger for heating.

[0383] The controller can actively adjust any of these thresholds to achieve an optimal moisture exchanger temperature profile, which may vary from patient to patient depending on its tidal volume, respiratory frequency, settings controlled by a trained operator, and / or its respiratory waveform. The controller may have a feedback loop that controls the timing of heating to reach the desired timing for moisture exchanger temperature, air temperature, and / or humidity delivery in the respiratory cycle.

[0384] Furthermore, the threshold can be adjusted to achieve the desired humidity level. For example, if the required humidity is low, cooling the moisture exchanger during exhalation can delay the reduction of excess moisture in the moisture exchanger. Alternatively, heating the moisture exchanger during inhalation can be delayed. This can also vary depending on the ambient temperature and humidity.

[0385] The thresholds mentioned above can be actively adjusted using a feedback loop, or they can be preset values, or they can be obtained from a lookup table. Alternatively, they can be controlled by the user via an interface that increases or decreases the desired humidification level.

[0386] Thermal control A certain heating time The controller may apply or remove heat from the moisture exchanger during a fixed period that is not (directly) dependent on the respiratory cycle duration. For example, the controller may apply heat over a period of 1 s or 2 s, or most preferably 1.5 s. In this way, the controller can ensure that all moisture is released from the moisture exchanger, that a predictable temperature is reached, and that once all moisture is released from the moisture exchanger, the moisture exchanger begins to cool as quickly as possible.

[0387] Peak and retention Preferably, the controller of the respiratory humidification device provides peak power at the start of the phase, rapidly raising the elements and moisture exchanger to a certain temperature, and then reduces its power a short time later, or when a specific temperature (resistance) is reached, or is calculated or expected to be reached.

[0388] Preferably, there are multiple power changes supplied to the heating element within the breathing cycle, and the breathing cycle includes a high-power phase, followed by a low-power phase, followed by a zero-power phase.

[0389] Preferably, during the high-power phase, the power is 100% or at least 75% of the maximum power that the controller can supply.

[0390] Preferably, during the low-power phase, the power is less than 70%, less than 50%, or less than 30% of the maximum power that the controller can supply.

[0391] Preferably, the low-power phase lasts for at least twice, or at least three times, or at least four times the length of the high-power phase.

[0392] Preferably, the high-power phase and the low-power phase together last for less than half the duration of the respiratory cycle, or more preferably less than 40% of the duration of the respiratory cycle.

[0393] Alternatively, the delivered power can be controlled at any stage of the respiratory cycle, either with respect to the flow rate or in proportion to the flow rate.

[0394] Alternatively, the delivered power may be controlled by open-loop feedforward control or closed-loop feedback control (or a combination thereof) to maintain a desired moisture exchanger temperature or air temperature for inhalation, including different temperatures at different points during inhalation or exhalation.

[0395] Preferably, during the high-power and low-power phases, the phases are controlled to maintain the moisture exchanger at a desired temperature for a period of at least 100 ms, or more preferably at least 200 ms, during inspiration, allowing time for the moisture exchanger to release moisture into the inspiratory flow. The desired moisture exchanger temperature is preferably LCST or above LCST. The described times depend on the application of the humidification device. For example, when used in a CPAP device, the time will be shorter, but when used in a tracheostomy tube or ventilator, the time may be up to 2 seconds longer. The supplied power (%) may also be adjusted.

[0396] Feedback control In another embodiment, the controller controls the temperature of the moisture exchanger using feedback from the moisture exchanger's temperature sensor. The controller may be a PID controller or a bangbang (thermostat) controller.

[0397] Error detection The respiratory humidification device / apparatus is preferably capable of detecting one or more error conditions. Error conditions include sensor errors (open circuit, short circuit, invalid signal, signal loss, etc.), heater / device errors (open circuit, short circuit, incorrect impedance), contamination of the heater or moisture exchanger, power supply exceeding acceptable limits, missing or incorrect moisture exchanger components or removable modules, ambient air conditions (temperature, humidity, pressure) exceeding normal operating limits, errors in replacing removable modules or other replaceable components within a reasonable timeframe (e.g., because usage has exceeded a safe amount since installation), respiratory problems such as the patient interface becoming detached, falling, or leaking, loss or change in air supply, and obstructions to the moisture exchanger that prevent air from passing through (e.g., high condensation, saliva, secretions).

[0398] These error conditions can result in unnecessary power consumption, unsafe operation, inappropriate or excessive output during treatment (flow rate, humidity, temperature, pressure), or discomfort to the patient.

[0399] Therefore, upon detecting an error condition, the respiratory humidifier may, preferably, alert the user or patient, or communicate with the patient, user, healthcare professional, or another part of the respiratory circuit, by sound (tone, noise, voice message), flashing light(s), or airflow interruption or restriction. The respiratory humidifier may cease operation in certain error conditions.

[0400] Furthermore, the respiratory humidification device may alert the user or patient by any of the above means when sleep apnea, respiratory failure, dyspnea, etc. occur, or when their frequency or value exceeds a threshold.

[0401] Leak detection A critical error condition in respiratory support devices is air leakage from the patient interface around the seal between the patient and the interface. This is particularly true for the respiratory humidification device of the present invention, as it generally needs to take in as much exhaled moisture as possible to provide maximum humidity. Therefore, it is desirable to have a method for detecting patient interface leak error conditions.

[0402] A further aspect of the present invention provides a method for detecting a leak error condition in the patient interface of a respiratory humidifier device according to another aspect of the present invention, the method comprising monitoring at least one sensor value associated with the airflow through the respiratory humidifier device, comparing the sensor value with a set of expected sensor values, and detecting an error condition when at least one sensor value falls within the range of the set of expected sensor values. The method is preferably performed at least every 10 respiratory cycles, preferably every cycle.

[0403] At least one sensor value can be a rate of change or a sensor value.

[0404] Leak error conditions in the patient interface can be detected by any of the methods disclosed in the prior art, for example, by measuring the average or peak flow rate through the respiratory humidifier. However, leak detection according to the above description may be advantageous because it can be performed closer to the patient and detected with higher accuracy, or because it is possible to more easily distinguish between leaks in the patient interface and leaks at another point in the air supply upstream from the moisture exchanger.

[0405] Regarding the example only Although the present invention is illustrated by the description of several embodiments, and several embodiments are described in detail, the applicant does not intend to thus limit the scope of the appended claims in any way. Additional advantages and modifications will be readily apparent to those skilled in the art. Therefore, the present invention is not limited in its broader embodiments to the specific details, representative apparatus and methods, and examples shown and described. Accordingly, deviations from such details may occur without departing from the spirit or scope of the applicant's overall inventive concept.

Claims

1. A respiratory humidification device, A moisture exchanger positioned in a respiratory system having an inspiratory and expiratory breathing cycle, wherein the moisture exchanger is positioned such that the airflow generated in the inspiratory and expiratory breathing cycle comes into contact with the moisture exchanger, and the moisture exchanger is temperature responsive and has a critical solution temperature. A heater and The system includes a controller that controls the power supply to the heater, and the controller controls the power supply to the heater. The heater raises the temperature of the moisture exchanger to a first target temperature at a first target point in the respiratory cycle, or to a temperature above the first target temperature, the first target point being the start of inspiration. The temperature of the moisture exchanger decreases to a second target temperature or below the second target temperature at a second target point in the respiratory cycle, and the second target point is at the start of exhalation. The critical solution temperature is the lower critical solution temperature (LCST), and during inhalation, moisture is added to the incoming air, and during exhalation, the moisture exchanger extracts moisture from the air. The first target temperature exceeds the second target temperature. The controller increases the power of the heater or switches on the heater before the respiratory flow rate changes from exhalation to inhalation, and / or The controller is a respiratory humidifier device that reduces the power of the heater or switches off the heater before the respiratory flow rate changes from inhalation to exhalation.

2. The respiratory humidifier according to claim 1, wherein the first target temperature is at least 0.5°C higher than the critical solution temperature, and the second target temperature is at least 0.5°C lower than the critical solution temperature.

3. The respiratory humidifier device according to claim 1 or 2, wherein the controller reduces the power of the heater or switches off the heater at an inspiratory time offset after a change in respiratory flow rate from exhalation to inhalation.

4. The respiratory humidifier according to claim 3, wherein the inspiratory time offset is less than 75% of the inspiratory period.

5. The respiratory humidifier device according to any one of claims 1 to 4, wherein the controller reduces the power of the heater at least 250 ms before the start of exhalation.

6. The respiratory humidifier device according to any one of claims 1 to 4, wherein the controller reduces the power of the heater at least 500 ms before the start of exhalation.

7. The respiratory humidifier device according to any one of claims 1 to 6, wherein the controller supplies peak power at the start of that stage.

8. The respiratory humidifier according to any one of claims 1 to 7, wherein the LCST is 25°C to 50°C.

9. The respiratory humidifier according to claim 8, wherein the LCST is 30°C to 45°C.

10. The respiratory humidifying device according to any one of claims 1 to 9, wherein the heater is selected from at least the group consisting of a filament, a spiral wire, an induction coil, a radiation heater, and an infrared heater.

11. A respiratory humidifier according to any one of claims 1 to 10, further comprising a water source.

12. The respiratory humidifier according to any one of claims 1 to 11, further comprising a user interface for adjusting the operation of the controller.

13. The respiratory humidifier device according to any one of claims 1 to 12, wherein the controller is a mechanical switch that is biased on or off using a spring, magnet, or other means.

14. The respiratory humidifier according to any one of claims 1 to 12, wherein the controller is a processor.

15. The respiratory humidifier device according to claim 14, wherein the controller is a predictive controller based on one or more of time offset, rest time, and flow rate.

16. The respiratory humidifier device according to claim 14 or 15, wherein the controller operates to adjust the amount of moisture extracted from the airflow or the amount of moisture added to the airflow.

17. A respiratory humidifier according to any one of claims 14 to 16, further comprising a sensor, wherein the controller operation responds to information received from the sensor.

18. The respiratory humidifier according to any one of claims 1 to 17, wherein the first target temperature or the second target temperature is adjustable according to a desired inhaled air temperature or the mode of the respiratory humidifier.

19. The respiratory humidifier device according to claim 18, wherein the mode is invasive ventilation or non-invasive ventilation.

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