Respiratory equipment adaptation

Abstract

Respiratory devices are used in a variety of settings, such as hospitals and medical facilities, to provide a flow of gas to patients. Improving compliance with the use of the respiratory device improves the therapeutic outcomes of these patients. In one aspect, a method and a respiratory device are described that provide a flow of gas, the respiratory device comprising: a flow generator; a humidifier that humidifies the gas flow; and a controller configured to operate the respiratory assistance device for acclimatization by reducing one or more of the humidity and temperature of the gas flow from an operating level to a comfort level and increasing one or more of the humidity and temperature of the gas flow from the comfort level to the operating level for a first period of time.

Description

[Technical Field]

[0001] The present invention relates to a respiratory apparatus and method for its use that promotes patient comfort. [Background technology]

[0002] Respiratory devices are used to deliver gas flows to patients in a variety of settings, including hospitals and healthcare facilities (commonly referred to as "hospital" settings, which may include facilities with trained medical staff), residential care facilities, and home settings (commonly referred to as home settings, which may not include trained medical staff). Respiratory devices may generally be used to deliver air and / or to provide supplemental oxygen or other gases in the gas flow, and / or may be used in combination with a humidifier to deliver heated and humidified gas. Respiratory devices may allow for control of parameters of the gas flow, including, but not limited to, flow rate, pressure, gas concentration, humidity, and temperature. Summary of the Invention

[0003] It is an object of the present invention to provide a method and / or apparatus that facilitates patient acclimatization to gas flow parameters such as humidity and temperature provided by a respiratory apparatus.

[0004] In one aspect, the present invention can be said to include a respiratory apparatus comprising a flow generator for providing a gas flow, a humidifier for humidifying the gas flow, and a controller configured to operate the respiratory assistance apparatus for acclimatization by reducing one or more of the humidity and temperature of the gas flow from an operating level to a comfort level and increasing one or more of the humidity and temperature of the gas flow from the comfort level to the operating level over a first period of time.

[0005] Optionally, one or more of the humidity and temperature of the gas stream are at an operational level before reducing one or more of the humidity and temperature of the gas stream.

[0006] Optionally, increasing one or more of the humidity and temperature of the gas flow comprises ramping one or more of the humidity and temperature of the gas flow over a first period of time.

[0007] Optionally, a duration of the first period of time is determined before reducing one or more of the humidity and temperature of the gas stream.

[0008] Optionally, the length of duration is at least about 10 minutes, at least about 15 minutes, at least about 30 minutes, about 30 to about 40 minutes, about 35 minutes, at least about 40 minutes, about 45 minutes, about 30 to about 50 minutes, about 30 to about 60 minutes, about 35 minutes to about 1 hour, at least about 1 hour, about 1 hour to about 2 hours, or up to about 2 hours, as calculated at a rate of about 1°C / 5 minutes to ramp from an initial comfort level to a driving level (e.g., it takes about 30 minutes to ramp from a 31°C dew point temperature to a 37°C dew point temperature).

[0009] Optionally, the period includes a maintenance period during which the device maintains the initial comfort level before ramping up to the driving level. For example, the maintenance period can be at least about 10 minutes, or at least about 15 minutes, or about 30-60 minutes. The maintenance period can be in addition to or in place of the ramping period.

[0010] Optionally, before reducing the humidity and / or temperature of the gas stream, the humidity and / or temperature of the gas stream has been at the operating level for at least about 10 minutes, at least about 15 minutes, at least about 30 minutes, between about 30 minutes and about 40 minutes, about 35 minutes, at least about 40 minutes, about 45 minutes, between about 30 minutes and about 50 minutes, between about 30 minutes and about 60 minutes, between about 35 minutes and about 1 hour, at least about 1 hour, between about 1 hour and about 2 hours, or up to about 2 hours.

[0011] Optionally, the operating level of humidity is about 31°C, 34°C, or 37°C dew point temperature at 100% RH.

[0012] Optionally, the initial comfort level of humidity is 3°C below the operating dew point temperature, for example, about 34°C dew point temperature when the operating level is a 37°C dew point temperature.

[0013] Optionally, one or more of humidity and / or temperature is decreased or increased by controlling a humidifier.

[0014] Optionally, the humidifier comprises a heating plate configured to heat water to humidify the gas stream.

[0015] Optionally, a breathing conduit is provided, the breathing conduit comprising a heater wire. Optionally, the heater wire is coupled or coupleable to an outlet of the humidifier.

[0016] Optionally, one or more of the humidity and temperature are reduced or increased by controlling one or more of the heating plate and heater wires.

[0017] Optionally, the humidity and / or temperature of the gas flow is present at one or more of the humidifier inlet, the interior of the humidifier, the humidifier outlet, the respiratory conduit, the respiratory conduit inlet, the respiratory conduit outlet, the patient interface, the patient interface inlet, and the patient interface outlet.

[0018] Optionally, the humidity of the gas stream is indicated by a humidity parameter.Optionally, the temperature of the gas stream is indicated by a temperature parameter.

[0019] Optionally, the humidity parameter is one or more of relative humidity, absolute humidity, dew point.

[0020] Optionally, the temperature parameter is one or more of the following: temperature of the gas flow, temperature of the heater plate, temperature of the heater wire.

[0021] Optionally, the respiratory assistance device further comprises one or more humidity and / or temperature sensors at one or more of the humidifier inlet, the interior of the humidifier, the humidifier outlet, the respiratory conduit inlet, the interior of the respiratory conduit, the respiratory conduit outlet, the patient interface inlet, the interior of the patient interface, the patient interface outlet.

[0022] Optionally, one or more humidity and / or temperature sensors are provided at one or more of the humidifier inlet, the interior of the humidifier, the humidifier outlet, the respiratory conduit, the respiratory conduit inlet, the respiratory conduit outlet, the patient interface, the patient interface inlet, and the patient interface outlet.

[0023] Optionally, the controller is configured to operate the respiratory assistance device for patient comfort based on one or more of receiving input from a user, an internal trigger, and activating the respiratory device.

[0024] Optionally, a metering device configured to control the water flow rate in the humidifier is provided.

[0025] Optionally, one or more of the humidity and temperature are decreased or increased by controlling one or more of the heating plate, heater wires and measuring devices.

[0026] Optionally, the step of reducing one or more of the humidity and / or temperature of the gas stream from the operating level to the comfort level is performed over a second period of time, the second period of time optionally being up to 1 hour, up to 30 minutes, up to 20 minutes, 5 to 15 minutes, or about 10 minutes, or less than 5 minutes.

[0027] Optionally, one or more of humidity and temperature are gradually transitioned over the first period of time, optionally the gradual transition being linear, stepwise or non-linear.

[0028] Optionally, the slope rate is predefined.

[0029] Optionally, the humidifier comprises a heated pass-over humidifier, a heated pass-over humidifier with a float, or an evaporative humidifier.

[0030] Optionally, determining whether a user has removed the patient interface, and determining whether to perform acclimation based on determining that the patient interface has been removed. Optionally, determining whether to perform acclimation includes determining one or more of the number of times or the length of time the patient interface has been removed.

[0031] Optionally, the comfort level comprises a dew point that is 30% to 75% lower than the operating level.

[0032] Optionally, one or more acclimation operations are used to increase or decrease one or more of the humidity and temperature of the gas stream.

[0033] Optionally, the device comprises a user interface, the user interface configured to allow a user to activate the adaptation. Optionally, the user interface comprises a button or a touch screen.

[0034] Optionally, selecting each of the one or more accommodation actions based on a determination of current patient comfort, optionally determined by one or more of removing the user interface and activating an accommodation button.

[0035] Optionally, the controller is configured to operate the respiratory assistance device for acclimatization by reducing the flow rate of the gas flow from an operating level to a comfort level and increasing the flow rate of the gas flow from the comfort level to the operating level over a first period of time.

[0036] Optionally, the reduction in flow rate and the increase in flow rate are performed simultaneously with a reduction in one or more of humidity and temperature and an increase in one or more of temperature, respectively.

[0037] Optionally, the reduction in flow rate and the reduction in one or more of humidity and temperature are performed separately.

[0038] Optionally, the operating level is a high flow therapy level.

[0039] In another aspect, the present invention can be said to include a respiratory assistance apparatus as defined in claim 1, comprising a temperature sensor at the outlet of the humidifier, wherein the humidity of the gas stream is indicated by a humidity parameter, the humidity parameter being a dew point, whereby a comfort level is a first dew point and an operating level is a second dew point, and wherein to increase the humidity from the comfort level to the operating level, the controller controls the apparatus to gradually transition the humidity of the gas stream by reducing power to the heating plate until the outlet temperature is below the first dew point and increasing power to the heating plate until the outlet temperature is above the second dew point.

[0040] Optionally, the first dew point set point is in a range of about 30% to about 75% lower than the second dew point, optionally in a range of 50% to 65% lower than the second dew point.

[0041] Optionally, the first dew point is a set point at least about 3 degrees lower than the second dew point, more optionally, a set point at least about 5 degrees lower than the second dew point, and even more optionally, the first dew point has a set point of about 27 degrees and the second dew point has a set point of about 37 degrees.

[0042] Optionally, the period of time ranges from about 15 minutes to 60 minutes, optionally from about 30 minutes to 45 minutes.

[0043] Optionally, the power is increased by increasing the duty cycle provided to the heating plate, optionally with the duty cycle ranging from about 10% to 80% for a period of time.

[0044] Optionally, the controller receives input to activate the ramped transition mode from a user interface, an external sensor and / or internal determination determining removal and / or non-compliant use of the patient interface, or activation.

[0045] In another aspect, the invention can be said to include a respiratory apparatus comprising temperature sensors at an outlet of the humidifier and at an outlet of the conduit, wherein the humidity and temperature of the gas stream are indicated by humidity and temperature parameters, the humidity parameter being a dew point, a comfort level being a first dew point and a first temperature, and an operating level being a second dew point and a second temperature, and wherein to increase the humidity and temperature from the comfort level to the operating level, a controller controls the apparatus to ramp the humidity and temperature of the gas stream by reducing power to the heated plate and heater wires until the temperature at the humidifier outlet is at or below the first dew point and the temperature at the conduit outlet is at or below the first temperature, and increasing power to the heated plate and heater wires until the temperature at the humidifier outlet and the temperature at the conduit outlet are at or above the second dew point and the second temperature.

[0046] Optionally, the humidity is increased from a first dew point to a second dew point over a first period of time.

[0047] Optionally, the temperature is increased from the first temperature to the second temperature over a second period of time.

[0048] Optionally, the first period and the second period are the same.

[0049] Optionally, the first period and the second period are different.

[0050] Optionally, the first and second temperatures are greater than the first and second dew points.

[0051] In another aspect, the invention can be said to include a respiratory apparatus comprising a flow generator for providing a flow of gas, a humidifier for humidifying the flow of gas, a user interface for interaction by a user, and a controller in electronic communication with the flow generator and the humidifier, the controller configured to control operation of the flow generator to generate the flow of gas and to control the humidifier to humidify the flow of gas, the controller further configured to be in electronic communication with the user interface to receive input from the user and to provide output to the user, the controller configured to enable a comfort mode in response to receiving an acclimation mode input via the user interface, and during the comfort mode the controller is further configured to reduce the humidity and / or temperature of the gas flow from an operating level to a comfort level and to increase the humidity and / or temperature of the gas flow from the comfort level to the operating level over a period of time.

[0052] Optionally, during comfort mode, humidity / temperature is ramped from operational levels to comfort levels over a period of time.

[0053] Optionally, a period of time can be predefined before the acclimation mode is initiated.

[0054] Optionally, the ramp transition is a linear ramp transition over the period of time.

[0055] In a further aspect, the present invention comprises a flow generator (blower), a humidifier in fluid communication with the blower, the humidifier configured to humidify gas, and a controller having two modes: a) an operating mode, and b) an acclimation mode, wherein the controller operates in the operating mode by default and the controller is configured to enable the acclimation mode upon user selection, wherein in the operating mode the flow generator is controlled to generate a flow rate of gas and the humidifier is controlled to humidify the gas to an operating humidity level, and in the acclimation or comfort mode the flow generator is unchanged (or generates the same flow rate as in the operating mode) and the humidifier is controlled to humidify the gas to a comfort level / acclimation level, wherein the comfort level or humidity is lower than in the operating mode.

[0056] Optionally, in the acclimatization mode, the operating humidity is high, reducing irritation to the patient and allowing the patient to adapt to the treatment.

[0057] Optionally, during the acclimation mode, the humidity is reduced to a comfort level and then increased over a period of time to an operating level.

[0058] Optionally, the period is a predefined period.

[0059] Optionally, the period is a user-defined period.

[0060] Optionally, during the acclimation mode, humidity is ramped from a comfort level to an operating level over a period of time.

[0061] Optionally, the humidity ramp transition is a linear ramp, optionally at a predefined ramp rate.

[0062] Optionally, humidity increases from a comfort level to an operating level in a non-linear trajectory over a period of time.

[0063] Optionally, the user may select multiple time periods.

[0064] Optionally, the flow rate is predefined (user or clinician selected).

[0065] Optionally, the device comprises a conduit in fluid communication with the humidifier and a conduit disposed between the humidifier and the patient interface, the conduit comprising a wall defining a gas cavity and a heater wire in thermal communication with the cavity to heat gas within the cavity.

[0066] In one aspect of the invention, a breathing apparatus may be said to include a flow generator for providing a gas flow, a humidifier for humidifying the gas flow, and a controller configured to operate the breathing aid apparatus for acclimatization by decreasing a parameter of the gas flow from an operating level to a comfort level and then increasing the parameter of the gas flow from the comfort level to the operating level over a period of time, Optionally, the parameter includes one or more of humidity and / or temperature, flow rate, pressure and gas concentration.

[0067] In one aspect, the present invention can be said to include a respiratory apparatus comprising a flow generator for providing a gas flow, a humidifier for humidifying the gas flow, and a controller configured to provide the humidity and temperature of the gas flow at a comfort level where one or more of the humidity and temperature of the gas flow are at a lower level than an operating level, and to operate the respiratory assistance apparatus for acclimatization by increasing the humidity and temperature of the gas flow from the comfort level to the operating level over a first period of time.

[0068] Optionally, the comfort level operates over a second period of time.

[0069] Optionally, before providing the comfort level, the step includes reducing one or more of the humidity and temperature of the gas stream from an operational level to a comfort level.

[0070] Optionally, one or more of the above features are included.

[0071] In one aspect of the present invention, a method of controlling a respiratory apparatus including a humidifier may be said to include an operational level method comprising the steps of providing the humidity and temperature of the gas flow in a conduit to a patient interface at a comfort level where one or more of the humidity and temperature of the gas flow are at a comfort level that is less than an operational level; and increasing the humidity and temperature of the gas flow from the comfort level to a comfort level.

[0072] Optionally, prior to reducing one or more of the humidity and temperature of the gas stream, one or more of the humidity and temperature of the gas stream is at an operational level.

[0073] Optionally, increasing one or more of the humidity and temperature of the gas flow rate comprises ramping the one or more of the humidity and temperature over a first period of time.

[0074] Optionally, a duration of the first period is determined before reducing the humidity and temperature of the gas flow.

[0075] Optionally, the duration of the first period is at least about 10 minutes, at least about 15 minutes, at least about 30 minutes, between about 30 and about 40 minutes, about 35 minutes, at least about 40 minutes, about 45 minutes, between about 30 and 50 minutes, between about 30 and about 60 minutes, between about 35 minutes and about 1 hour, at least about 1 hour, between about 1 and about 2 hours, or up to about 2 hours, as calculated at a rate of about 1°C / 5 minutes to ramp from the initial comfort level to the operating level (e.g., it takes about 30 minutes to ramp from a 31°C dew point temperature to a 37°C dew point temperature).

[0076] Optionally, before reducing one or more of the humidity and / or temperature of the gas stream, one or more of the humidity and / or temperature of the gas stream has been at an operating level for at least about 10 minutes, at least about 15 minutes, at least about 30 minutes, between about 30 minutes and about 40 minutes, about 35 minutes, at least about 40 minutes, about 45 minutes, between about 30 minutes and about 50 minutes, between about 30 minutes and about 60 minutes, between about 35 minutes and about 1 hour, at least about 1 hour, between about 1 hour and about 2 hours, or up to about 2 hours.

[0077] Optionally, the operating level of humidity is about 31°C, 34°C, or 37°C dew point temperature at 100% RH.

[0078] Optionally, the comfort level includes humidity 3° C. below the operating dew point level.

[0079] Optionally, one or more of humidity and temperature are reduced or increased by controlling a humidifier.

[0080] Optionally, the humidifier comprises a heating plate configured to heat water to humidify the gas stream.

[0081] Optionally, one or more of the humidity and temperature are reduced or increased by controlling one or more of a heating plate and heater wires inside the breathing conduit.

[0082] Optionally, one or more of the humidity and / or temperature of the gas stream are sensed at one or more of the humidifier inlet, the interior of the humidifier, the humidifier outlet, the respiratory conduit, the respiratory conduit inlet, the respiratory conduit outlet, the patient interface, the patient interface inlet, and the patient interface outlet.

[0083] Optionally, the humidity of the gas stream is indicated by a humidity parameter and the temperature of the gas stream is indicated by a temperature parameter.

[0084] Optionally, the humidity parameter is one or more of relative humidity, absolute humidity and dew point.

[0085] Optionally, the temperature parameter is one or more of the temperature of the gas flow, the temperature of the heater plate, and the temperature of the heater wire.

[0086] Optionally, the method includes receiving an instruction to initiate acclimatization. Optionally, the instruction includes one or more of receiving input from a user, an internal trigger, and activating a breathing apparatus.

[0087] Optionally, a metering device configured to control the water flow rate in the humidifier is provided.

[0088] Optionally, one or more of the humidity and temperature are reduced or increased by controlling one or more of the heating plate, heater wires and measuring devices of the humidifier.

[0089] Optionally, the step of reducing one or more of the humidity and / or temperature of the gas stream from the operating level to the comfort level is performed over a second period of time, the second period of time optionally being up to 1 hour, up to 30 minutes, up to 20 minutes, 5 to 15 minutes, or about 10 minutes, or less than 5 minutes.

[0090] Optionally, one or more of humidity and temperature are ramped over the first period of time, optionally the ramp is linear, stepwise or non-linear, and optionally the ramp rate is predefined.

[0091] Optionally, the humidifier comprises a heated pass-over humidifier, a heated pass-over humidifier with a float, or an evaporative humidifier.

[0092] Optionally, determining whether the user has removed the patient interface, and deciding whether to perform an acclimation process based on the determination that the patient interface has been removed, optionally wherein determining whether to perform the acclimation process includes determining one or more of the number of times or the length of time the patient interface has been removed.

[0093] Optionally, the comfort level comprises a dew point that is 30% to 75% lower than the operating level.

[0094] Optionally, one or more acclimation operations are used to increase or decrease one or more of the humidity and temperature of the gas stream.

[0095] Optionally, selecting each of the one or more accommodation actions based on a determination of current patient comfort, optionally determined by one or more of removing the user interface and activating an accommodation button.

[0096] Optionally, reducing the flow rate of the gas flow from an operational level to a comfort level, and increasing the flow rate of the gas flow from the comfort level to the operational level over a first period of time.

[0097] Optionally, the reduction in flow rate and the increase in flow rate are performed simultaneously with a reduction in one or more of humidity and temperature and an increase in one or more of temperature, respectively.

[0098] Optionally, the reduction in flow rate and the reduction in one or more of humidity and temperature are performed separately.

[0099] Optionally, the operating level is a high flow therapy level.

[0100] As used herein, the term "non-sealing patient interface" (i.e., non-sealing patient interface) may refer to an interface that provides a pneumatic link between a patient's airway and a source of gas flow (such as from the flow generator 11) that does not completely occlude the patient's airway. A non-sealing pneumatic link may include less than about 95% occlusion of the patient's airway. A non-sealing pneumatic link may include less than about 90% occlusion of the patient's airway. A non-sealing pneumatic link may include between about 40% and about 80% occlusion of the patient's airway. The airway may include one or more of the patient's nostrils and / or the patient's oral cavity. In the case of a nasal cannula, the airway is through the nares. In some configurations, a "non-sealing patient interface" may include a tracheal interface.

[0101] The term "comprises" as used herein means "consisting at least in part of." When interpreting each statement herein that includes the term "comprises," features other than those preceded by the term may also be present. The related terms "comprises" and "comprises" may be interpreted in the same manner.

[0102] Reference to a range of numerical values ​​disclosed herein (e.g., 1 to 10) is intended to incorporate a reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any rational number range within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7). [Brief explanation of the drawings]

[0103] Examples are described with reference to the following figures:

[0104] [Figure 1] 1 is a block diagram of a respiratory device in which embodiments of the present invention may be implemented; [Figure 2] FIG. 2 is a flow diagram of a general example of a method for acclimatizing a patient to an operating level of flow therapy that may be implemented in the respiratory apparatus of FIG. 1. [Figure 3] FIG. 2 is an alternative flow diagram of an optional example that can be implemented in the respiratory device of FIG. 1 where the respiratory device can detect patient discomfort and trigger by providing a comfort button option for the patient to manually activate acclimatization. [Figure 4] FIG. 2 is a flow diagram of a first example method for acclimatizing a patient to an operating level of flow therapy that may be implemented in the respiratory apparatus of FIG. 1. [Figure 5] FIG. 2 is a flow diagram of a first example method for acclimatizing a patient to an operating level of flow therapy that may be implemented in the respiratory apparatus of FIG. 1. [Figure 6] 10 is a plot of an exemplary change in humidity over several minutes following activation of the acclimation trigger, showing a linear change in dew point. [Figure 7] 10 is a plot of an exemplary change in humidity and temperature over several minutes from activation of an acclimation trigger, showing the linear change in dew point and temperature. [Figure 8] 10 is a plot of an exemplary change in humidity over several minutes following activation of an acclimation trigger, showing a gradual change in dew point. [Figure 9] 10 is a plot of an exemplary change in humidity over several minutes following activation of an acclimation trigger, illustrating the non-linear change in dew point. [Figure 10]FIG. 1 is a block diagram of an alternative respiratory device in which embodiments of the present invention may be implemented. [Figure 11] FIG. 11 is a flow diagram of an example of a method for acclimatizing a patient to an operating level of flow therapy that may be implemented in the respiratory device of FIG. 10. DETAILED DESCRIPTION OF THE INVENTION

[0105] It should be noted that references to humidity are made herein. There are various parameters that can directly or indirectly indicate humidity, such as relative humidity, absolute humidity, and dew point. All of these can be interchangeably converted using associated conversion parameters. For example, dew point can be converted to relative humidity if the associated barometric pressure and temperature are known. Therefore, references to humidity refer to the concept itself and are not limited to a specific parameter type that can define or indicate humidity. Also, while the examples refer to one type of humidity parameter (e.g., dew point), this is not limiting; the same concepts described can be applied using other humidity parameters. This description is directed to humidity control and should not be limited to a specific parameter used to indicate humidity. However, it should be noted that parameters that can be used to indicate humidity may not actually be a direct measurement of humidity or may be different from other parameters that indicate humidity. While such parameters may be convertible, they are not necessarily directly interchangeable and are distinct parameters with their own technical applications. For example, in some situations, certain parameters, such as one or more of dew point, relative humidity, and absolute humidity, may be easier to calculate or better suited to certain methods than others. overview

[0106] Respiratory devices (also known as "respiratory therapy devices," "respiratory support devices," or "respiratory assist devices") can provide patients with respiratory gas at a controlled flow rate and / or pressure to support respiratory function. This can occur in both hospital and home settings. Respiratory support typically includes (but is not limited to) high-flow therapy (also known as nasal high-flow therapy, HFT, or NHF, for patients with pulmonary diseases such as dyspnea, respiratory distress, pneumonia, emphysema, and other obstructive pulmonary diseases), biphasic / NIV pressure support (including various submodes such as S / T mode and T mode), CPAP support (for OSA), and humidified respiratory therapy. Such respiratory devices can include a humidifier to control the humidity of the respiratory gas delivered to the patient. The temperature of the respiratory gas delivered to the patient can also be controlled. The humidity and / or temperature are provided to improve the patient's experience and health. As a non-limiting example, flow therapy uses a respiratory device 1 to provide a flow of gas to a patient at a flow rate (e.g., 15 L / min or more), temperature (e.g., 37°C), and humidity (e.g., 37°C dew point or 44 mg absolute humidity).

[0107] When in operation, respiratory apparatus 10 has operating parameters that may include gas flow parameters such as gas flow humidity, temperature, oxygen fraction, pressure, and / or flow rate. When providing therapy, respiratory apparatus 10 has operating parameters at operating levels (i.e., parameter values), which are the parameter levels at which therapy is provided. A typical parameter value (a non-limiting example) is 100% RH (relative humidity) and a dew point of 37°C. Other dew point settings would be any one or more of 31°C, 34°C, and 37°C.

[0108] When the device is in use but not providing therapy, the operating parameters may be at non-operating levels. Typically, operating parameters can be described as therapy parameters, and the operating levels may be designated levels, user-defined levels, therapy levels, or similar levels, depending on the purpose and / or how the operating parameters are designated. These may be different levels or the same levels depending on the operating situation. Examples include:

[0109] Prescribed Level - A specified parameter value specified by a clinician. Typically, the prescribed level will be an operational level such as a therapeutic / prescribed level for the parameter appropriate for patient treatment.

[0110] User-set level - a parameter value set by a user. Typically, the specified level will be an operational level, such as a therapeutic / prescribed level of the parameter appropriate for patient treatment, but may also be some other level and / or specified by the user.

[0111] Therapeutic level - a parameter value (e.g., 37°C dew point at 100% RH). Other dew point settings can be operating parameters (31°C, 34°C) set at a therapeutic level to provide therapy (CPAP, NHF, bi-level, humidified support, etc.) to a patient. It can also be a prescribed level; that is, the therapeutic level can be set or prescribed by a clinician who recommends use to a patient.

[0112] Prescribed Level - The parameter value of the operating parameter set to the level prescribed by the clinician. It may also be the therapeutic level.

[0113] Generally speaking, the driving level of a driving parameter is the value provided during driving to provide therapy, regardless of what designates it or how or who sets it. Also, in some cases, a driving parameter may be at a non-driving level such that no therapy is provided or the set or prescribed therapy level is not provided. This may include an initial comfort level, as described below.

[0114] Compliance with treatment is a key requirement for achieving therapeutic results, especially for patients receiving flow therapy at home. Implementing a therapy such as high-flow therapy for a precise, prescribed time is helpful for achieving therapeutic results. Patients at home should use the respiratory device 1 in the prescribed manner (e.g., for a prescribed number of hours per day, e.g., at least four hours per day at the prescribed flow rate, humidity, temperature, and / or other prescribed parameters). The prescription (e.g., prescribed treatment level) is provided by the patient's physician, clinician, etc. Alternatively, if the patient feels short of breath or has difficulty breathing, the patient may be encouraged to use the respiratory device to reduce strain. The patient can use the respiratory device if necessary. Generally, the longer the patient uses the respiratory device, the better the patient's outcome.

[0115] However, the temperature and humidity of the breathing gas at operating levels due to the heated and humidified gas flow can cause discomfort to some patients. For example, patients may complain of hot, moist, or hot, sticky sensations around the nose and lips when breathing humidified and heated air. This discomfort can reduce patient compliance with treatment. For example, patients may not use the breathing device for the prescribed amount of time. This issue is particularly problematic in home settings where there is no clinician available to provide support. Clinicians want patients to adhere to treatment. Many patients receiving home treatment have chronic conditions such as COPD and are often treated with NHF or biphasic therapy. Patients with sleep apnea syndrome are treated with CPAP, and compliance is important for this patient group as well. That said, compliance is also important for hospitalized patients. Hospitalized patients generally have more severe acute respiratory illnesses or may experience exacerbated symptoms. Compliance and use of treatment is also very important for patients with acute respiratory illnesses.

[0116] The present invention relates to improving patient comfort when using respiratory apparatus, and thus improving compliance with respiratory apparatus use / treatment. This disclosure demonstrates that by encouraging patients to acclimate (i.e., become accustomed to / tolerate) gas flow (operating) parameters (e.g., temperature and humidity), the patient experience (comfort) may be improved, and therefore compliance may be improved. However, patients often do not have medical staff (e.g., nurses) or other technical staff available to assist them with adjusting humidity and temperature.

[0117] The present embodiment provides a respiratory apparatus 10 for providing a gas flow having flow rate, pressure, oxygen fraction, temperature, humidity (gas flow (operating) parameters), where the humidity and / or temperature gas flow parameters are controllable (acclimation operation) to help the patient acclimate to the specified humidity and / or temperature, thereby helping the patient achieve compliance.

[0118] Patient acclimation means that the humidity / temperature gas flow parameters are changed over time without causing discomfort that the patient might experience if the operating level(s) of the operating parameter(s) were too high for patient comfort. Rather, the acclimation method ensures that the patient feels comfortable while the operating parameter(s) are brought up to the operating level(s). Comfort means that as the operating parameter level is changed over time, the parameter level is tolerable to the patient at each point until the patient becomes accustomed to the level, and then the level is further changed until the operating level is achieved. The time period over which the parameter is changed is long enough to allow the patient to become accustomed to the parameter. This improves patient compliance by making the patient comfortable and tolerable to the delivery of the gas flow. The acclimation method may be performed, for example, immediately after the operating level(s) of the operating parameter(s) are delivered or may be performed some time after the delivery of the operating parameter(s). The acclimation method may also be proactively provided before the operating level is delivered in anticipation of potential patient discomfort. Other triggering times may also be used.

[0119] By way of non-limiting example, the initial comfort level is the humidity and / or temperature level at which the heated and humidified gas flow causes minimal discomfort to the patient, i.e., the level at which the patient can tolerate the temperature, humidity, and other parameters of the gas flow in such a way that the patient is more likely to use the respiratory device. Typically, the initial comfort level for a parameter will be lower than the operating level for that parameter. The initial comfort level is not the only level of the operating parameter that the patient can tolerate, but it is a level used as a starting point. The temperature and / or humidity are increased over a period of time until the operating level is reached. The temperature and humidity may first be maintained at the initial comfort level for a maintenance period (which may be part of or separate from the period) before being increased. As the temperature and / or humidity of the gas flow are increased over time from the initial comfort level to the operating level, the patient is able to acclimate to the increasing humidity and / or temperature and tolerate it once the operating humidity and / or temperature level is reached. This is because the patient is able to acclimate to each level of the operating parameter as it increases. The period is long enough and the ramp is gradual to allow the patient to acclimate to the humidity and / or temperature, meaning that the patient is more likely to use the respirator at the prescribed operating level and therefore compliance is more likely to be achieved.

[0120] Acclimation can occur at any convenient time, such as after the respiratory device has "warmed up." Acclimation refers to the reduction of humidity and / or temperature parameters from an operating level (which may be a prescribed level or another level designated by the treating clinician or the patient) to an initial comfort level over a period of time, followed by a subsequent increase back up to the operating level over a period of time. Prior to the increase, temperature and humidity may be maintained at the initial comfort level for a maintenance period. References to increasing temperature and / or humidity over a period of time may be considered to include maintaining the initial comfort level during a maintenance period that is a portion of the overall period during which the parameters are increased. This gradual increase in humidity and / or temperature ("ramped transition" or "ramp rate") helps the patient acclimate to those parameters. A ramp rate can be defined as the change in a parameter over time, such as the change in humidity over time (e.g., %RH change per minute) or the change in temperature over time (e.g., degrees Celsius change per minute). However, as discussed below, acclimation can also occur at other times. The period / ramp rate is long enough and the slope is gradual enough to allow the patient to acclimate to the humidity and / or temperature. The ramp rate can be linear (constant slope) or non-linear over time. The ramp rate can be set in steps. If there is a maintenance period, the ramp rate becomes linear after the maintenance period.

[0121] It should be noted that the duration will vary depending on the temperature and humidity changes, and in such cases, there will be an overall acclimation period during which all humidity and / or temperature parameters are changed to achieve acclimation, but the actual period during which any of them are changed may be a different, shorter period. Examples of breathing apparatus

[0122] There are various examples of respiratory apparatus 10 that can be operated to facilitate a patient's acclimation to operating levels of gas flow (operating) parameters, such as humidity and / or temperature. The respiratory apparatus 10 will be described, followed by a description (by way of example) of general examples in which the respiratory apparatus 10 is configured to perform humidity and / or temperature acclimation. Some examples are described below, and should not be considered limiting to other variations that may result in the described acclimation.

[0123] Various operations, parameters, etc. described in any of the examples should not be limited to only the examples, and can be used in combination with other examples. The described examples do not necessarily cover all of the embodiments, and do not necessarily mean that they are mutually independent.

[0124] Figure 1 shows a generic example of a respiratory apparatus 10 that uses a conduit 55 with a heater wire 58 and a patient interface 51 (which may be sealed or non-sealing depending on the use, as described below, with a non-sealing version shown in Figure 1) to deliver a flow of gas to a patient to provide respiratory assistance, where the respiratory support may include pressure therapy / support and / or optionally flow therapy / support and / or optionally humidification support (see below). The respiratory apparatus is configured to deliver a flow of gas 31 at a target pressure and / or flow rate. The breathable gas may be humidified, for example by a humidifier 52.

[0125] The operating arrangement may include a controller 19 configured to control the respiratory apparatus 10. The controller 19 may control the apparatus using suitable control techniques to control the pressure, flow rate, temperature, humidity, oxygen concentration and / or other operating parameters of the gas stream. To achieve this, the controller may implement pressure and / or flow rate control techniques to adjust the pressure and / or flow rate, and may further include humidity and / or oxygen concentration control techniques. For example, the controller 19 may control components of the respiratory apparatus 10, including, but not limited to, operating the flow generator 50B to create a flow of gas (gas stream) to be delivered to the patient, operating the humidifier 52 (if present) to humidify and / or heat the generated gas stream (e.g., by controlling the humidifier's heating plate), controlling the flow of oxygen to the flow generator blower, operating the heater wires 58 to control temperature and humidity, controlling the oxygen fraction in the gas stream, receiving user input from the user interface 15 for reconfiguration and / or user-defined operation of the respiratory apparatus 10, and outputting information to the user (e.g., on the display 54). Wherever an action is described herein as being performed by the apparatus 10, it will be understood that the action may be performed by the controller 19 controlling one or more components of the apparatus 10.

[0126] The respiratory apparatus 10 may be integrated into a single housing, such as the dotted box 11, or may be a separate configuration of individual components as shown within the dotted box 11 in FIG. 1. Additionally, in some configurations, the apparatus 10 may be a modular arrangement of components 19, 52, and 50B. Accordingly, the apparatus may be referred to as a "system," although these terms are used interchangeably and without limitation. While the apparatus will be referred to hereinafter as a "device," this should not be considered limiting. The integrated configuration of the apparatus 10 into a single housing offers advantages such as convenience and ease of use, reduced risk of component loss (especially in a busy hospital environment), and improved compliance rates. It also offers easier humidification and flow control due to a shorter flow path between the flow source and the humidifier. When device / system 10 is comprised of multiple separate components, these components are not necessarily dedicated to one another. For example, the present disclosure may include the use of a separate humidifier 52. The humidifier 52 may be connected to an external flow source 50, e.g., a hospital flow source, and may be designed for use with a respiratory apparatus having a different flow source. In this case, the humidifier 52 alone, even before being connected to a flow source, may be considered a respiratory apparatus and is considered to be included in the term "respiratory apparatus" herein.

[0127] Device 10 may be configured as any suitable device for any suitable purpose. For example, respiratory device 10 may be, but is not limited to, a flow therapy device, a humidified respiratory device, a CPAP (Continuous Positive Airway Pressure) device, a bilevel / NIV device, etc. The device may be any type of pressure- and / or flow-controlled respiratory device capable of providing pressure and / or flow therapy support and / or humidification support. Alternatively, the device may be a multi-therapy device capable of providing one or more combinations of therapies, including nasal high-flow (NHF) therapy, humidified respiratory therapy, continuous positive airway pressure (CPAP) therapy, and non-invasive ventilation (NIV), e.g., bilevel pressure therapy. Device 10 may have one or more control modes associated with each therapy. That is, one device 10 may provide two or more therapies. Alternatively, device 10 may be dedicated to one or more therapy methods. The control mode may be selected manually by the user or automatically depending on the components connected to the device (e.g., depending on the type of tubing or patient interface connected to the device). Each control mode may have an associated control method for controlling the components of the device (e.g., flow generator, humidifier heater, conduit heater).

[0128] The components of the device are described in detail with reference to FIG. 1. FIG. 1 illustrates various components that may be present to provide flow therapy, CPAP, bi-level / NIV, and / or humidification devices that provide one or more of high-flow, high-pressure, and / or humidification therapies. Not all components are required for a particular device. While an unsealed cannula is shown as an example of the patient interface 51, as previously mentioned, the device 10 may be configured for one or more other therapies, including pressure and / or flow control and / or humidification therapies, and a sealed interface may be used instead if desired.

[0129] The apparatus 10 includes a flow source 50 for providing a high gas flow 31, such as oxygen or a mixture of oxygen and one or more other gases, to provide the oxygen fraction, or more generally, the gas fraction, of the gas flow. Alternatively, the apparatus 10 may have a connection for coupling to the flow source 50. As such, the flow source 50 may be considered to form part of the apparatus 10 or may be considered a separate component from the apparatus 10, depending on the context. Also, a portion of the flow source 50 may form part of the apparatus 10, or even a portion of the flow source may be external to the apparatus 10.

[0130] The flow source 50 can be an in-wall oxygen supply, an oxygen tank 50A, other gas tanks, and / or a high-flow therapy device with a blower / flow generator 50B. FIG. 1 shows the flow source 50 with a flow generator 50B. The flow source 50 has an optional air inlet 50C and an optional connection to an O source (such as a tank or O generator) 50A via a shutoff valve and / or regulator and / or other gas flow control 50D, but this is only one option. The following description applies to both examples. The flow source can be any one or combination of the flow generator 50B, O source, and / or air source, as described above. While the flow source 50 is shown as part of the device 10, it may be considered a separate component in the case of an external oxygen tank or in-wall source, in which case the device has a connection port for connecting to such a flow source 50. Flow source 50 provides a flow-controlled and / or pressure-controlled (optionally high flow) flow of gas that can be delivered to a patient via conduit 55 and patient interface 51 .

[0131] In some configurations, the respiratory apparatus 10 may not include a flow generator 50B. In this case, the apparatus 10 does not generate a gas flow, but instead is configured to be connected to an external flow generator and configured to humidify the gas flow from the external flow generator. For example, the respiratory apparatus 10 may be used as a stand-alone humidifier 52 to humidify the gas flowing through the respiratory apparatus 10. The flow generator may be a wall gas supply (e.g., regulated via a flow meter or rotameter) or other stand-alone flow generator that can be configured to provide any of the therapies described elsewhere herein (e.g., NIV, biphasic, NHF, CPAP, humidification therapy, etc.). The user may select one or more of these therapies / modes.

[0132] The conduit 55 may be provided with a heater wire 58 that is controllable to heat the gas within the conduit 55. The conduit is coupled or coupleable at one end to a gas outlet of a water chamber 57 of a humidifier 52 within the housing 11 of the respiratory apparatus 10. Depending on the end use, the patient interface 51 may be any suitable interface coupled or coupleable to the apparatus 10, including one or more of the following:

[0133] non-sealing (also called "non-sealing") interfaces (e.g., when used in high-flow therapy), such as nasal interfaces (cannulae) with manifolds and nasal prongs, and / or face masks, and / or nasal pillow masks, and / or nasal masks, and / or endotracheal tubes, and / or tracheostomy interfaces, or other suitable types of patient interfaces; or Sealing interfaces such as nasal masks, full face masks, and nasal pillows (e.g., for use with NIV and CPAP).

[0134] A humidifier 52, comprising a water chamber 57 and a base / heating plate 59, can be positioned between the flow source 50 and the patient to humidify the delivered gas. This may be a humidifier integrated with the flow source 10 to form an integrated device 11 (see dotted line), or a separate humidifier (e.g., a flow generator) that is detachable from the flow source 10. The heating plate may be or include a heater element, a heating surface, or other device suitable for providing heat to a liquid such as water. The heating plate may have an exposed heating surface, may be formed from multiple layers including at least one heating element, and / or may form part of the humidifier base. In either case, the heating plate is configured to evaporate water directly from the water chamber, from a volume of water placed on the heating plate, or otherwise.

[0135] Alternatively, the humidifier 52 may be a stand-alone humidifier (connectable / disconnectable to a flow source) with a water chamber 57 and a base, in which case the humidifier is coupled to the flow source 10 via a conduit 61 or other suitable means. The device 10 (or the humidifier 52, if stand-alone) may include one or more sensors and a controller configured to control the humidifier based on sensor measurements. The humidifier controller may be the same as the device controller 19, may be combined with the device controller 19, may be part of the device controller 19, or may be coupled to the device controller 19. For example, the humidifier 12 may include a temperature sensor and a flow sensor. The humidifier 12 may humidify the gas stream or heat the gas stream to an appropriate humidity / temperature level. A controller (e.g., the device controller 19) may be configured to control the humidifier 52 (e.g., by controlling at least the humidifier heater). The humidifier 52 may be optional or may be preferred due to the benefits that humidified gases provide in maintaining airway integrity. Humidification is optionally used in conjunction with high-flow gas streams to enhance patient comfort, compliance, support, and safety.

[0136] The heater wires 58 are controlled by a controller to heat the gas stream 31 to further control the temperature and / or humidity of the gas stream.

[0137] One or more sensors 53A, 53B, 53C, 53D, 53E, 14 or other sensors, such as flow rate, oxygen fraction, pressure, humidity (dew point, RH, or AH), temperature, etc., can be located throughout the device and / or near, on the skin, or in close proximity to the patient. Alternatively or additionally, sensors capable of deriving such parameters may be used. Additionally or alternatively, the sensors 14, 53E can include one or more physiological sensors for sensing patient physiological parameters, such as heart rate, oxygen saturation (e.g., pulse oximeter sensor / SPO2 53E), partial pressure of oxygen in the blood, respiratory rate, partial pressure of O2 and / or CO2 in the blood, etc. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors include EEG sensors, waist bands for detecting respiration, and other suitable sensors. The one or more sensors may form part of the device or may be external to the device, with the device providing inputs for any external sensors. The sensors can be placed in any suitable location appropriate for what they sense, including, but not limited to, the inlet or outlet of the flow generator or source, the inlet or outlet of the humidifier, the heater plate 59, the conduit 55, the patient end of the conduit (end of hose "EOH"), the patient interface 51, and / or the patient. FIG. 1 shows sensor 53A located at the output of the flow generator and sensor 53B located between the flow generator and the humidifier. Sensors 53A and 53B are shown on the conduit 61. Sensor 53B may be located at the inlet of the humidifier 52. Sensor 53C is located at the outlet of the humidifier or at the inlet of the conduit 55. Sensor 53D is located on the conduit 55. In some cases, it may be located near or upstream of the patient interface 51 end of the conduit. Sensor 53E is configured to be attached to the patient. Additional sensors may be used as needed to provide appropriate feedback to the controller 19 or to sense gas flow parameters. In some cases, the ambient temperature sensor is located before the flow generator 50B.

[0138] Output from the sensors is sent to a controller 19 to assist in controlling the device 10, particularly the following:

[0139] A flow generator 50B or flow source 50B that controls the flow rate and / or pressure of the gas stream. Humidifiers and / or heater wires to control the temperature and / or humidity of the gas stream The oxygen fraction of the gas stream, alternatively or additionally, input can be obtained from a user.

[0140] Control parameters such as humidity, temperature, flow rate, pressure, oxygen fraction, etc., can be controlled at any suitable location, such as the end of the respiratory conduit 55, the patient interface 51, the gas outlet, the humidification chamber outlet, any of the device's sensors 53A-53D, other locations where a sensor(s) is located, and / or combinations thereof. Parameters can be controlled relative to setpoints (targets). These setpoints include a desired dew point (e.g., a temperature indicating a desired humidity), a predetermined dew point, a predetermined temperature, or a desired temperature (these are merely non-limiting examples).

[0141] Controller 19 may be coupled to and control flow source 50, humidifier 52, and sensors 53A-53D, and / or any other components. The controller controls these and other aspects of the device, as described below.

[0142] The controller 19 may also control other appropriate parameters of the flow source 50 to meet the oxygenation requirements / fraction, such as a mixing valve, such as a proportional valve. The controller 19 may also control the humidifier 52 based on feedback from sensors 53A-53E, 14. While six are shown by way of example, any suitable number may be used and located in any suitable location. The controller 19 may use input from the sensors to determine the oxygenation requirements and provide information to a medical professional (who may control components of the respiratory apparatus 10 to provide the desired therapy (e.g., flow rate, O2 fraction, humidity)) or to control parameters of the flow source, temperature, and / or humidifier as needed.

[0143] The controller 19 is also configured to operate the apparatus 10 to control the flow rate, pressure, volume, and / or other parameters of the gas provided by the flow source based on feedback from the sensors, or optionally without feedback (e.g., using default settings). The controller 19 can also control other appropriate parameters of the flow source 50 to meet oxygenation requirements. The controller 19 can employ a sensor feedback loop. Broadly speaking, this involves collecting new sensor measurements, using sensed metrics to determine the current state of the gas in the device, comparing the current state to a target value, and adjusting the system output to achieve the target value.

[0144] The controller 19 may receive inputs from a number of sensors as feedback on the progress of the ramp (e.g., humidity ramp process), including humidity, ambient temperature, pressure, humidifier inlet air temperature, humidifier outlet gas temperature, heater plate temperature, power supplied to the heater plate, flow rate, inlet dew point, etc.

[0145] An input / output interface 54 (e.g., a display and / or input devices) is provided ("user interface") for receiving information from a user (e.g., a clinician or patient) that can be used to determine, for example, oxygenation requirements, anesthetic gas agent, detection, flow rate, gas fraction, partial pressure, and / or other parameters that may be controlled by apparatus 10.

[0146] The device 10 also includes a display 45, which may be part of the I / O 54, for displaying measured gas parameters of the expiratory gas stream as a graph, digital display, or other suitable means. Any sensor information or operating parameter, such as humidity, temperature, flow rate, pressure, oxygen fraction, SPO2, etc., may be displayed.

[0147] The respiratory apparatus 10 may also include a communications module 15 that enables the controller 19 to receive signals 8 from the sensors and control various components of the respiratory assistance apparatus 10, including, but not limited to, the flow generator 50B, the humidifier 52, the heater, the humidifier heater 59, or accessories or peripherals associated with the respiratory apparatus 10. Additionally or alternatively, the communications module 15 may transmit data to a remote server or allow remote control of the respiratory apparatus 10 or respiratory therapy system. The communications module 15 (also referred to as a transceiver) may transmit various information, such as usage information, the number of times a comfort mode has been initiated, comfort mode parameters (e.g., ramp duration, ramp rate), and operating mode parameters (e.g., humidity, temperature, flow rate).

[0148] Communications module 15 may include a transmitter, a receiver, and / or a transceiver, such as a modem, a WIFI™ transceiver, a BLUETOOTH™ transceiver, or any other suitable transceiver.

[0149] The communication module 15 may function as a network interface (eg, a modem).

[0150] Respiratory apparatus 10 may comprise or be in the form of a high-flow therapy device. When configured to provide high-flow therapy, one or more operating parameters of the high-flow therapy (also called nasal high-flow therapy or NHF therapy) may comprise any combination of the following:

[0151] The therapeutic flow rate of gas provided to the user; Therapeutic humidity level (e.g., relative humidity, absolute humidity, dew point, etc.) The therapeutic concentration of auxiliary gas (e.g., O2) provided to the user; · (For example) the therapeutic temperature of the gas provided to the user.

[0152] High flow therapy, as discussed herein, is intended to be given its typical ordinary meaning as understood by those skilled in the art, and generally refers to a breath-assist device that delivers a target flow rate of humidified respiratory gas through an intentionally unsealed patient interface at a flow rate intended to match or exceed the patient's inspiratory flow. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric patients (such as neonates, infants, and children) often range from about 1 liter per minute per kilogram of patient body weight to about 3 liters per minute per kilogram of patient body weight or more, but are not limited to these. High flow therapy also optionally includes the administration of a gas mixture composition containing supplemental oxygen and / or a therapeutic agent. High-flow therapy is often referred to as high-flow nasal oxygen (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen therapy (HFNO), high-flow therapy (HFT), or high-flow tracheostomy (THF), among other common names.

[0153] For example, in some configurations, for an adult patient, "high flow therapy" may refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater, e.g., from about 10 LPM to about 100 LPM, or from about 15 LPM to about 95 LPM, or from about 20 LPM to about 90 LPM, or from about 25 LPM to about 85 LPM, or from about 30 LPM to about 80 LPM, or from about 35 LPM to about 75 LPM, or from about 40 LPM to about 70 LPM, or from about 45 LPM to about 65 LPM, or from about 50 LPM to about 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high flow therapy" may refer to the delivery of gas to a patient at a flow rate greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to 15 LPM, or from about 20 LPM to 25 LPM. High flow therapy devices with adult, neonatal, infant, or pediatric patients may, in some configurations, deliver gas to a patient at a flow rate of from about 1 LPM to about 100 LPM, or at a flow rate in any of the subranges outlined above. The delivered gas may include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas can be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%.

[0154] High-flow therapy can be effective in meeting or exceeding a patient's inspiratory flow, increasing the patient's oxygenation, and / or reducing the work of breathing. High-flow therapy can be administered into the patient's nares and / or orally or via a tracheostomy interface.

[0155] High-flow therapy can create a washout effect in the nasopharynx, such that the anatomical dead space in the upper airway is washed away by the high inflow gas flow. This can create a reservoir of fresh gas available for each breath while reducing nitrogen and carbon dioxide rebreathing. Meeting inspiratory demand and flushing the airway are additionally important when attempting to control the patient's FDO2 (fraction delivered with oxygen). High-flow therapy can be delivered using a non-sealing patient interface, such as a nasal cannula. High-flow therapy can reduce the patient's respiratory rate. High-flow therapy can provide the patient with expiratory resistance.

[0156] High flow therapy may be used to treat patients with obstructive pulmonary diseases such as COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema and / or patients with respiratory distress or hypercapnia.

[0157] Respiratory apparatus 10 may comprise or take the form of a bilevel / NIV respiratory apparatus. Bilevel therapy involves providing gas to a user at the therapies IPAP and EPAP (and optionally one or more operating parameters described in more detail below). Respiratory apparatus 10 may comprise or take the form of a CPAP respiratory apparatus providing CPAP therapy. CPAP therapy may involve supplying gas to a user at a constant pressure. Respiratory apparatus 10 may comprise or take the form of a humidified respiratory apparatus providing humidified therapy.

[0158] In some configurations, the device may include at least one battery as part of a battery module 125 (with an optional battery cover 126). The battery module 125 may be located within the housing 11 of the device 10 and / or attached to the exterior of the housing 11 of the device. It will be understood that when the term "battery" is used herein, it may refer to the battery itself or the battery module 125 that comprises the battery. The battery module 125 can provide power when a mains power source is unavailable (as a battery source). For example, this allows a patient to receive therapy and / or comfort modes while wearing the device 10 and moving around. In some configurations, the battery is removably coupled to the device and is rechargeable. In some configurations, the battery is removable and optionally connectable and disconnectable from the device 10. Alternatively, the battery is not removable. In some configurations, the battery is provided as part of the same housing as the flow generator and / or humidifier. In some configurations, the battery is provided as connectable and disconnectable from the same housing as the flow generator and / or humidifier. Having the battery as part of the housing or capable of being connected and disconnected from the housing allows the device to be more portable than other devices (e.g., larger devices such as ventilators or devices that have external battery power and are not portable). The portability of the device may improve the usability of the device in a home care environment by allowing the device to be more easily moved around a user's home. In a hospital environment, portability allows the therapy device to be moved around the hospital with the patient, allowing the patient to continue receiving therapy during the transfer.

[0159] The respiratory apparatus 10 of Figure 1, in any of its forms, can be configured to provide for acclimation of humidity and / or temperature gas flow parameters ("humidity and / or temperature"), as illustrated in the manner of Figure 2. A controller 19 of the apparatus 10 operates the apparatus as described above. Typically, acclimation of gas flow (operating) parameters is associated with acclimation of the temperature and humidity of the gas flow (the discussion will focus on these parameters as examples).

[0160] The respiratory apparatus 10 is configured to control the temperature and / or humidity of the gas stream over time in a timely manner to acclimate the patient to the operating levels of humidity and / or temperature (operating parameters) such that the patient is more likely to feel comfortable and comply, with the period being sufficiently long and the ramp being gradual to allow the patient to become accustomed to the humidity and / or temperature.

[0161] Regarding humidity and temperature, it should be re-emphasized here that humidity and temperature are operating parameters, and that decreasing or increasing humidity and temperature means decreasing or increasing the level of the operating parameter. Various levels (values) can be set for the operating parameters, such as an initial comfort level, an operating level, or any level in between. An operating level is the operating parameter level (value such as degrees, dew point, or relative humidity percentage) provided during normal operation / treatment. For example, the level value for the operating parameter may be a dew point temperature of 37°C at 100% RH. Other dew point settings may be 31°C or 34°C.

[0162] In general, the respiratory apparatus 10 may be configured to activate an acclimation method that performs an acclimation operation to provide an acclimation result. That is, the method varies the temperature and / or humidity of the gas over time (by the method) from an initial comfort level to an operating level that provides comfort and acclimates the patient (acclimation result). This initial comfort level of humidity and / or temperature may be a level that is comfortable or tolerable to the patient. As the operating parameters reach the operating level, the patient may acclimate, thereby becoming comfortable when the gas flow 31 reaches the operating level. Activating the acclimation method may be considered to transition the apparatus into a "comfort mode" of operation. An example of an initial comfort level parameter value may include (as a typical and non-limiting example) a predetermined temperature below the dew point temperature of the operating level. For example, the dew point temperature of the initial comfort level may be 3°C below the dew point temperature of the operating level; for example, if the operating level is a dew point temperature of 37°C, the comfort level may be a dew point temperature of 34°C. Any suitable reduction from the dew point temperature of the operating level may be possible.

[0163] Respiratory apparatus 10 may do this by performing an acclimation operation, which may control heating plate 59 and / or heater wires 58 to control the humidity and / or temperature of gas flow 31. In general, an acclimation operation may include controlling one or more of the following:

[0164] Controlling the heating plate 59 so that the temperature and / or humidity of the gas stream 31 is reduced to an initial comfort level and then increased over time to an operational level; and Controlling the heater wires 58 to reduce the temperature and / or humidity of the gas stream 31 to an initial comfort level and then increasing it over time to an operational level; and Both the heating plate and the heating wire, and A flow generator 50B and / or a humidifier 52 or other components of the respiratory apparatus 10.

[0165] Control of the heater plate 59 and / or heater wires 58 may, if desired, include controlling the power to the heater plate 59 and / or heater wires 58. This can be done in a variety of ways. This may be achieved by controlling the voltage and / or current to the heater plate 59 / heater wires 58, for example by controlling the duty cycle, the magnitude of the voltage / current, or in any other suitable manner.

[0166] The adaptation can be implemented in a variety of ways, some examples of which are given below.

[0167] · Modification of closed-loop control of humidity and / or temperature at the water chamber outlet, Changing the temperature and / or humidity settings at the chamber outlet and / or patient end, Open-loop control of the power supplied to the heating plate and / or heater wires; and Closed or open loop of other parameters that indirectly control the temperature and / or humidity at the water chamber outlet and / or the patient end of conduit 55.

[0168] A general acclimation method will now be described with reference to Figure 2. At an appropriate time during operation of the respiratory apparatus 10 (step 80), the respiratory apparatus may be triggered (step 81) to provide temperature and / or humidity acclimation (hereinafter referred to as "acclimation" or "acclimation method"). The respiratory apparatus 10 then performs an acclimation operation (step 88) to change the operating parameters to a comfort level (step 82). Thereafter, after a delay or other operation, one or more acclimation operations (step 88) may be initiated to return the operating parameter(s) to the operating level (step 83).

[0169] The trigger for step 81 may be an operating mode, or may be an "acclimatization mode," "comfort mode," or other name indicating the function / purpose of the mode. As previously mentioned, this is configured to promote patient comfort and adaptation to therapy, thereby improving compliance. Adaptation may occur or be triggered to occur at any time, such as:

[0170] When starting up the machine ("start-up"); Patient triggers, Triggered by the patient to occur during the warm-up period / mode (when the ventilator reaches a predetermined temperature). Warm-up mode may be triggered at start-up and / or from standby mode. Warm-up mode may also be triggered at any other time. Warm-up mode may occur during a non-operating level period, or It may be during the operation period (including the start of the operation period).

[0171] Typically, but not necessarily, the respiratory apparatus 10 is triggered to provide acclimatization at a later stage after the warm-up period, e.g., during driving. The apparatus 10 may trigger the acclimatization method at step 81 manually (e.g., by the patient or other driver operating the respiratory apparatus via the user interface 54, the communications interface 15, or the like) or automatically (e.g., by detecting current driving conditions that cause the respiratory apparatus to determine that acclimatization action should be taken). These options are discussed below.

[0172] As part of the acclimation method, humidity and / or temperature (operating parameters) are changed (using acclimation operations 88). These changes may be configured to cause fluctuations in humidity and / or temperature of the gas stream. The acclimation operations 88 are operations performed by the respiratory apparatus 10 to change the humidity and / or temperature in order to perform the acclimation method and achieve an acclimation result.

[0173] In some cases, the following will be determined:

[0174] Whether an acclimatization outcome is required (e.g., whether a change in humidity and / or temperature is required to achieve acclimatization) and / or the adaptation actions to be performed, One or more of the following characteristics may be considered: The heating plate 59 has the greatest effect on the humidity of the gas stream 31. Typically, in controlling the humidity of the gas stream 31, the temperature of the heating plate 59 determines the rate of evaporation of water in the humidification chamber 52, thereby controlling the humidity of the gas stream 31. At the same time, it also affects the temperature of the gas stream. The heater wire 58 controls the temperature of the gas stream 31 in the conduit 55 (sometimes called the breathing tube) and maintains the temperature of the gas stream a few degrees above the estimated dew point to prevent condensation from forming. Generally, the temperature of the conduit 55 is the primary determinant of the temperature of the gas delivered to the patient (i.e., near the patient interface 51).

[0175] The acclimation operation 88 is performed by the controller 19 controlling the breathing apparatus 10 to change the humidity and / or temperature parameters necessary to achieve an acclimation result. The acclimation result may include a change in the humidity and / or temperature parameters, such as an increase or decrease in humidity and / or temperature. For example, the acclimation operation 88 may involve controlling the heating plate 59 to adjust the humidity and / or temperature from an initial comfort level, and then increasing the humidity and / or temperature to the operating level. Alternatively or additionally, the heating wire 58 may be controlled to adjust the humidity and / or temperature from an initial comfort level, and then increasing the humidity and / or temperature to the operating level (including any parameter maintenance period).

[0176] Some non-limiting examples of acclimation operations 88 in a typical acclimation method are described below. When the respiratory apparatus 10 is triggered to perform acclimation (step 81), if the humidity and / or temperature parameters of the respiratory apparatus 10 are above or not at the initial comfort level, one or more of the humidity and / or temperature parameters are reduced to the initial comfort level (step 82) (the initial comfort level refers to a state in which the operating parameters are at a level that the user can tolerate). This reduction step is not necessary if the respiratory apparatus 10 is already operating or already providing the operating parameters at the initial operating comfort level. In other cases, the comfort level may be set based on the operating level, such as a predetermined level below the operating level or a percentage reduction from the operating level.

[0177] By activating the heating plate 59 and / or the heated conduit 55 (acclimation action) and reducing the temperature and / or humidity of the gas stream (acclimation result), the humidity and / or temperature parameters are reduced to an initial comfort level. For example, to reduce the humidity and / or temperature parameters to an initial comfort level, one or more of the following example acclimation actions may be performed to achieve the acclimation result:

[0178] Reduced heating plate output and reduced humidity of the gas stream at the water outlet and / or patient interface.

[0179] · Heating plate power is reduced, reducing the temperature of the gas stream at the water chamber outlet and / or patient interface.

[0180] Reduced heating plate power and / or heater wire power, reducing the temperature of the gas flow to the patient.

[0181] Humidity will decrease, but the temperature will increase as a result, so reduce the power of the heating plate and / or heater wires to reduce the temperature.

[0182] · Heater wires are controlled to vary the relative humidity.

[0183] Heating plates and heater wires may be controlled to reduce the dew point.

[0184] It should be noted that when varying humidity by lowering / increasing the humidity level, it refers to a humidity parameter that indicates or represents dew point, absolute humidity, relative humidity, or other type of humidity. The exact nature of the parameter used is not important to the present invention.

[0185] The humidity and / or temperature may optionally be maintained at a comfort level during the maintenance period. Over time, a reverse operation (or one or more acclimation operations 88 to achieve the opposite result of the initial acclimation operation 88) is performed to increase ("rampe") the humidity and / or temperature of the gas stream to the operating level 83. (Increasing the humidity and / or temperature parameters over a period of time is sometimes referred to as a "rampe" or "ramp rate.") This period may be long enough, or the rate of ramp slow enough, to allow the patient to acclimate to the humidity and / or temperature at each stage or step of the ramp, or to not notice the gradual increase.

[0186] The operating parameters may be increased by increasing the temperature and / or humidity of the gas stream by activating the heating plate 59 and / or heated conduit 55. For example, to increase the humidity and / or temperature from an initial comfort level to an operating level, one or more of the following acclimatization actions may be performed to achieve an acclimatization result:

[0187] The power delivered to the heating plate is increased for a period of time to raise the humidity of the gas stream at the water outlet and / or patient interface to operational levels.

[0188] · Raising the temperature of the gas stream at the water chamber outlet and / or patient interface to an operational level by increasing the power delivered to the heating plate over a period of time.

[0189] · The power delivered to the heating plate and / or heater wires is increased over a period of time to reduce the temperature of the gas stream at the patient.

[0190] · Heater wires are controlled to vary the relative humidity.

[0191] Heating plates and heater wires may be controlled to reduce the dew point.

[0192] It should be noted that the above list of acclimatization actions 88 for controlling the heating plate and heater wires to reduce to an initial comfort level and return to an operating level is not an exhaustive list of all acclimatization actions 88 that can be used to achieve an acclimatization result. Furthermore, two or more acclimatization actions 88 may be combined to achieve acclimatization. In some cases, different acclimatization actions 88 may be used to reduce and increase the same operating parameter, even when returning to the same operating level, step 83.

[0193] Some aspects of the acclimatization method are described in more detail below. In one manual (user-input) trigger of step 81, a patient (or other operator) may determine that they are experiencing discomfort and wish to activate the acclimatization method. For example, while respiratory apparatus 10 is in normal operating mode and providing operational level parameters, the patient may experience discomfort from the gas flow due to excessive humidity and / or temperature. The patient may trigger acclimatization method 81 by activating user interface 45. For example, the user interface of respiratory apparatus 10 may include a "comfort" button or the like (e.g., a push button, a series of button presses, access to a menu, a rotary dial, etc.). Pressing the comfort button instructs controller 19 to trigger the acclimatization method.

[0194] In another automatic (internal) trigger option (step 81), the respiratory apparatus 10 itself may determine that an acclimatization method is necessary based on some operating condition that suggests the patient is uncomfortable with the operating parameters at the current operating level, which triggers an acclimatization action 88 towards a comfort level in step 82.

[0195] As one option, the controller 19 detects whether the patient interface 51 is removed from the patient's face multiple times (e.g., three times) during the same treatment session or within a certain time frame. Removal may be detected by changes in airflow, sensors, etc. Removal of the patient interface 51 multiple times during the same session indicates treatment discomfort for the patient. The frequency and duration of each interface 51 removal may be tracked. A comfort button or similar means may be provided on the user interface 45 to allow the patient to initiate adaptation if multiple removals are detected during a single treatment session. Alternatively, adaptation may be automatically initiated if multiple removals are detected during a single treatment session. Any adaptation process may be initiated or suggested to the patient upon reaching a threshold number of removals, or based on the number of removals within a rolling time frame, or the duration of removals. As yet another example, adaptation may be automatically initiated whenever a removal is detected, or when it is detected that the patient interface 51 has been reattached to the patient's face.

[0196] Alternatively, the controller 19 detects whether the patient interface 51 has been permanently removed. Removal of the patient interface 51 indicates that the patient is experiencing discomfort and has discontinued use of the device and continued treatment. A natural response for a patient undergoing treatment is to remove the interface delivering gas when discomfort occurs. The respiratory apparatus 10 may determine whether the patient is using the interface based on, for example, sensors or changes in flow rate. The frequency and duration of removals may also be tracked. If removal is detected, a comfort button or similar means may be provided on the user interface to allow the patient to activate acclimatization, see FIG. 3 . A warning, such as an audio or visual alert, may be configured to prompt pressing the comfort button. Alternatively, acclimatization may be automatically activated if removal is detected.

[0197] Removal of the patient interface 51, for example removal of a nasal cannula, may be detected based on any one or more of the following:

[0198] Detection of flow fluctuations at a flow sensor within the breathing device (e.g., an internal flow sensor). Flow fluctuations are detected and compared to a reference threshold or waveform.

[0199] Analyze the gas flow signal to determine the patient's respiratory rate. The absence of a breathing pattern in the data may suggest that the mask is not being worn.

[0200] Use of a pulse oximeter or other physiological sensor integrated into the respiratory support device. For example, the absence of a detected signal may indicate that the patient is not wearing the interface.

[0201] Pressure fluctuations of the gas in the conduit may be used to detect the breathing cycle of a patient wearing the interface, for example this may be measured directly with a pressure sensor or by detecting oscillations in the motor speed.

[0202] If a threshold or criterion for removal of the patient interface 51 is met, an alert may be initiated to indicate to the patient that accommodations may be or will be used.

[0203] As described above, if acclimation is activated (step 81), as part of the acclimation, gas flow operating parameters such as humidity and / or temperature may be altered using one or more acclimation actions 88 to achieve one or more acclimation results. For example, as part of the acclimation, the humidity and / or temperature parameters may be lowered (action) to bring the humidity and / or temperature parameters to an initial comfort level (outcome) (step 82). After the comfort level is achieved in step 82, the parameters may be increased (acclimation action 88) to reach an operating level (outcome) step 83. In some cases, the acclimation action may be increased or decreased during a ramp-up to provide a gradual transition to the operating level and promote patient comfort. The acclimation action 88 itself may be implemented in a variety of ways by controlling components of the respiratory apparatus 10.

[0204] Discomfort is often caused by humidity, but may also be caused by any combination of exercise parameters (e.g., humidity, temperature). To address discomfort, acclimatization actions may be performed by any suitable means. Typically, humidity may be controlled by controlling the heating plate 59 according to a predetermined dew point / humidity at the outlet of the water chamber 57, or typically, the heater wire 58 may be controlled to control the temperature at the patient end. These may often be used in combination. However, these are not essential control means, and any suitable control for controlling the heating plate 59 and / or heater wire 58 to control humidity and / or temperature may be used to perform the acclimatization method / action.

[0205] For example, a heating plate 58 may be used to control the temperature, or a heater wire 59 may be used to control the humidity. Also, temperature control may be used to control humidity and / or humidity control may be used to control temperature. General, non-limiting examples of acclimation operations 88 to accomplish steps 82 and 83 include the following:

[0206] Humidity control by one or more of the following: Control of humidity setpoint (dew point, relative humidity, or absolute humidity) at the water chamber outlet and closed-loop control of power delivery to the heating plate to achieve varying humidity setpoints Controlling the temperature setpoint of the heater plate and achieving a variable heater plate temperature setpoint by supplying power to the heater plate using closed-loop control; and Ramp the power to the heating plate (e.g., change the duty cycle) to control humidity using open-loop control; and / or Controlling temperature by one or more of the following: Controlling the temperature setpoint at the patient end and powering the heater wires using closed loop control to achieve varying humidity setpoints Controlling the heater wire temperature setpoint and delivering power to the heater wire using closed-loop control to achieve a varying heater wire temperature setpoint; and Ramp the power to the heater wires (e.g., vary the duty cycle) to control the temperature with open-loop control.

[0207] An illustrative example of an adaptation operation 88 is as follows:

[0208] If the respiratory apparatus 10 uses closed-loop control to control the temperature and humidity to a set point (i.e., a target temperature or humidity), the acclimation operation 88 may modify the set point. The acclimation operation 88 may also be a subsequent closed-loop control that targets the control to the new set point. Of course, it may include a step increase in the set point if a step increase in the humidity and / or temperature parameters is part of the acclimation operation 88.

[0209] For example, the humidity of the gas stream may be reduced to an initial comfort level 82 and then increased over a period of time to an operational level 83. That is, the humidity may be ramped to the operational level. To achieve this, the power to the heater plate is ramped and the temperature of the heater plate is ramped (thereby ramping the humidity of the gas stream). To do this, the power to the heater plate is ramped over a period of time. The controller 19 controls the power to the heater plate to ramp according to a profile over a period of time. The period may be defined as described below. The period defines the rate of change of the humidity ramp. A longer period results in a gentler humidity ramp and more time for the patient to acclimate.

[0210] There are many ways to control the heating plate 59 and / or heater wires 58, typically by controlling power to the heating plate and / or heater wires via voltage and / or current control. By way of example and not limitation, in operation of the respiratory apparatus 10, the heating plate 59 is controlled by a PID controller (proportional-integral-derivative controller) to ramp from ambient temperature to the temperature required to achieve the desired dew point temperature as quickly and accurately as possible. Implementing a humidity ramp using PID control can be accomplished in several ways.

[0211] In the first method, the acclimation method is initiated (step 81), and after an initial comfort level is reached (step 82), a PID controller with different parameters is used to ramp the humidity up to the operating level. If the PID settings used during normal device operation are adjusted to approach ideal control (minimal rise time, minimal overshoot, no steady state error), the PID settings applied when ramping the humidity are different, adjusted to have a longer (patient-configurable) rise time period. This may be achieved by reducing the proportional and integral gain constants.

[0212] Another method of adaptive control is to limit the voltage or current supplied to the heating plate until an initial comfort level is reached. The controller 19, which determines the operation of the heating plate 59, determines the power supplied to achieve the desired gas temperature (operating temperature level) and associated dew point (operating humidity level). The rate of temperature rise can be controlled by scaling the output of the PID controller or limiting the maximum power. This allows for an extended time to reach the target temperature while maintaining the desired steady-state conditions achieved by optimal tuning of the PID control.

[0213] Another method of control is to measure the temperature at the water chamber outlet of the humidification chamber 52 (e.g., using sensor 53C, which may be a temperature sensor) or at the elbow where the conduit 55 connects to the respiratory apparatus 10, and control according to a variable target temperature (setpoint from initial comfort level to operating level). The target temperature is set by the user (e.g., clinician), and the controller 19 controls the heating plate 59 using closed-loop control to control the gas temperature measured at the chamber outlet to the target temperature. The target temperature is assumed to be the dew point temperature, and this acclimatization 88 achieves humidity control from the initial comfort level 82 to the operating level 83.

[0214] Alternatively, a variable target temperature is set by the user. The target flow rate is set by the user. The controller 19 calculates the target hotplate temperature and controls according to the target hotplate temperature by measuring the hotplate temperature with the hotplate temperature sensor.

[0215] Alternatively, the voltage or current may be ramped, or the voltage or current set point may be ramped. As yet another alternative, the applied duty cycle may be ramped at a predetermined rate. The heating plate 59 is powered with duty cycle control. The duty cycle may be reduced to achieve a lower temperature, and then the duty cycle target may be ramped to achieve the humidity and temperature ramp.

[0216] Alternatively, the difference between the target dew point at the start of the humidity ramp and the low starting point can be input into the control system as multiple incremental increases in the target dew point rather than as a single change. The size of the increments and the delay time between successive increases can be used to predictably set the overall ramp transition period. Using this method, the existing optimal PID tuning can be applied during each setpoint increase up to the target dew point.

[0217] Alternatively, the respiratory apparatus 10 may be operated to provide operating parameters at predetermined levels, predetermined gas stream temperature, humidity, and flow rate. A patient may experience discomfort with the temperature and / or humidity at the patient end, thereby initiating an acclimation operation by adjusting the operating parameters of the apparatus. One result of the acclimation operation is to ramp the humidity of the gas stream, gradually acclimating the patient to the predetermined treatment setting. The apparatus accomplishes this by gradually "ramping" the humidity setting from a lower setpoint to the operating parameter setpoint and controlling the heater plate 59 (acclimate operation 88). In some embodiments, the ramp function may be initiated when the patient experiences discomfort. This causes the controller 19 to reduce power to the heater plate 59, thereby reducing the heater plate temperature and reducing the humidity of the gas stream to a comfortable humidity level. The controller 19 ramps the power to the heater plate over a period of time under closed-loop control. This ramps the temperature to a target value, changing from the lower setpoint to the operating parameter setpoint, and increases the humidity of the gas stream until it reaches the operating level. Alternatively, the controller 19 may reduce the power to the heater wires to reduce the temperature of the gas stream, and then increase the power to the heater wires in stages over a period of time to increase the lower temperature.

[0218] For example, rather than gradually increasing the set point, it may be set to an operational level and then another control method may increase the power to the heating plate 59 and / or heater wires 58 to bring the humidity and / or temperature parameters up to the operational level (e.g., by changing the duty cycle).

[0219] Alternatively, the heater wire 58 may be controlled to maintain the temperature above the dew point. Typically, the patient end setpoint is set a preset amount higher than the chamber outlet setpoint, e.g., 3°C higher. This reduces condensation. The heater wire may also be controlled to change the humidity or temperature of the gas stream.

[0220] These are merely exemplary embodiments, and the present invention is not limited thereto. Other control methods are known to those of ordinary skill in the art, and the acclimatization operations described herein may be performed using any suitable control method that provides suitable control of humidity and / or temperature parameters to achieve patient acclimatization.

[0221] When performing the adaptation operation 88, the controller 19 may use one or more of the sensors 53A-53E and the input 14 to obtain the necessary information. The controller 19 may use the same sensor feedback loop as in the normal operating mode. Broadly speaking, this involves collecting new sensor measurements, using the sensed metrics to determine the current state of the gas in the device, comparing the current state to a target value, and adjusting the system output to achieve the target value.

[0222] The controller may take inputs from a number of sensors as feedback during the humidity ramp process. · Humidity, Ambient temperature, pressure, the temperature of the air at the inlet of the humidifier, the temperature of the gas at the outlet of the humidifier; the temperature of the heating plate, the power supplied to the heating plate, flow rate, and Any one or more of the following may be included: Inlet dew point

[0223] These sensors are Humidifier inlet, Inside the humidifier, Humidifier outlet, breathing tube inlet, Inside the breathing tube, Breathing tube outlet, Patient interface entrance, Inside the patient interface, and Measurements can be taken at any suitable location, such as at any one or more of the patient interface outlets.

[0224] The acclimation period requires a predetermined period of time, which is the time during which the acclimation operation 88 is performed. The period of time may affect the temporal profile over which the humidity and / or temperature parameters change. The acclimation period may be determined by any suitable method to allow the patient to acclimate to the humidity and / or temperature parameters of the operating level. Optionally, this period includes a maintenance period during which the device maintains an initial comfort level before transitioning to the operating level. The maintenance period may be added instead of or in place of the ramp-up period.

[0225] For example, the time period (or periods) may be manually set by a user (e.g., a patient or healthcare professional), or there may be multiple time periods that the patient can select, such as short, medium, and long periods. These time period settings may be predefined and stored in memory in the flow generator.

[0226] It should be noted that the time periods for temperature variation and humidity variation, or variation of other humidity and / or temperature parameters, may be different, and in such cases there will be an overall acclimation period during which all humidity and / or temperature parameters are varied to achieve acclimation, but the actual period during which any of them are varied may be different, shorter periods.

[0227] The period(s) may be defined based on various factors that facilitate patient compliance, which may include:

[0228] The response speed of the device, and The time it takes for the patient to develop a tolerance to humidity and temperature.

[0229] Some periods are calculated at a rate of approximately 1°C / 5 minutes to ramp from the initial comfort level to the operating level (e.g., it takes approximately 30 minutes to ramp from a 31°C dew point to a 37°C dew point). for at least about 10 minutes, for at least about 15 minutes, for at least about 30 minutes, Approximately 30 to 40 minutes Approximately 35 minutes for at least about 40 minutes, Approximately 45 minutes Approximately 30 to 50 minutes Approximately 30 to 60 minutes Approximately 35 minutes to 1 hour At least about an hour, Approximately 1 to 2 hours, or It can include up to about 2 hours.

[0230] · _ In some cases, the device may not immediately ramp to the acclimatization mode. Rather, the device may provide or maintain an initial comfort level for a period of time (which may be referred to as a maintenance period) before ramping to the driving level. For example, the comfort level may be maintained for at least about 10 minutes, or at least about 15 minutes, or about 30 to 60 minutes, according to the above-described periods, before ramping. The period may be considered to include the maintenance period during which the initial comfort level is maintained, or the maintenance period may be in addition to the period.

[0231] Patient / user preferences may be stored in the memory of the respiratory device 10 as part of a patient profile. Alternatively or additionally, the patient profile may be stored on a remote server. The patient profile may be retrieved by the respiratory device from the remote server. The profile may include acclimation parameters. The patient may be configured to specify and store one or more acclimation parameters, such as duration / ramp rates for humidity and temperature. The duration and ramp rates, as well as other acclimation parameters, may be predefined. The respiratory device may apply these acclimation parameters when the user initiates the acclimation process.

[0232] Acclimatization is particularly useful for home healthcare patients who use the respiratory apparatus 10 for extended periods and / or without nursing care. Home healthcare patients use the respiratory apparatus 10 in a home environment, separate from (or in addition to) use in a hospital or medical facility. Acclimatization settings selected by the patient and / or the controller may track patient-selected settings, and if a common setting exists, the controller may determine it as the preferred setting. The preferred setting may be stored.

[0233] Several non-limiting examples of implementing the exemplary adaptation method described above are described below.

[0234] A first example will now be described with reference to Figure 4. The apparatus of Figure 1 is configured to implement the acclimatization method of Figure 4 (in addition to other normal operations, step 30). This results in an example example apparatus and method. This example relates to flow therapy by way of example, although the method and apparatus are not so limited. In this example, humidity is varied. Dew point is a parameter for indicating humidity, but as noted above, this is only one option and similar acclimatization can be performed using any other humidity parameter.

[0235] First, at step 30, the respiratory apparatus 10 delivers flow therapy in the normal manner. It also monitors for a trigger (initiated by either the patient or the apparatus) (step 31). If a trigger is detected, the method activates an acclimatization method. For example, the user may press a comfort button or provide a comfort-enhancing input via the UI 45. The trigger may be initiated manually if the user experiences discomfort. Alternatively, the respiratory apparatus 10 may initiate the trigger if it detects that the interface 51 has been removed more than a predetermined threshold. Removal of the interface 51 beyond the threshold is an indicator that the patient is having difficulty achieving comfort or continuing flow therapy. Therefore, the controller 19 may automatically initiate acclimatization or provide an option to initiate acclimatization if it determines that the interface 51 has been removed more than a threshold number of times (see FIG. 3). In this example, acclimatization involves ramping the humidity from an initial comfort level to an operating level to allow the user to better acclimate to the humidity at a particular flow rate.

[0236] The controller 19 then performs an acclimation operation 88, controlling the dew point at the water chamber outlet through closed-loop control to reduce humidity. To do this, the controller 19 is configured to determine a lower dew point setpoint (initial comfort level humidity gas flow parameter) in step 32. For example, the new dew point may be in a range of about 30% to about 75% lower than the current dew point. Optionally, the new dew point may be in a range of about 50% to about 65% lower than the current dew point. Optionally, the new dew point setpoint may be set at least about 3°C ​​lower than the current setpoint. Optionally, it may be set at least about 5°C lower. In one example, the dew point is reduced by about 10°C. For example, it may be reduced from about 37°C to about 27°C. The lower limit of the minimum dew point setpoint is about 25°C. In other words, the power output of the heater plate may be reduced by about 10% to about 30%.

[0237] Next, under closed-loop control to meet the dew point, the controller 19 reduces the power supplied to the heater plate 59 in step 33. For example, to reduce the power, the duty cycle to the heater plate 59 may be reduced. Or, the power to the heater plate 59 may be shut off completely. Or, the voltage or current to the heater plate 59 may be shut off. Optionally, the power to the heater plate may be shut off to reduce the dew point as quickly as possible. The power to the heater wires 58 may be maintained at the same limit value. Feedback is based on the EOH (end of hose) temperature sensor 14, which still uses 37°C as the setpoint. This ensures that condensation does not occur or is reduced.

[0238] The temperature at the water chamber outlet is measured using chamber outlet temperature sensor 53C. Heating plate 59 is maintained at reduced power until the chamber outlet reaches the lower dew point setpoint (e.g., the measured chamber outlet temperature is lower than the initial comfort level).

[0239] Next, the controller 19 performs an acclimation operation 88 in step 34 to ramp the humidity back up to the operational level. The controller is configured to control the heater plate to ramp the humidity to the operational level. This is done by ramping the dew point from a lower setpoint (initial comfort level) back to the user setpoint (operating level). Under closed-loop control, the controller 19 is configured to control the power to the heater plate 59 to ramp the dew point temperature from the initial comfort level of approximately 25°C to the operational level of approximately 37°C over a predetermined period (or at a predetermined ramp rate). For example, the period may be in the range of 15 minutes to 1 hour, and optionally in the range of 30 minutes to 45 minutes. The ramping of the humidity may be accomplished by ramping the dew point, i.e., the chamber outlet temperature. Alternatively, the chamber humidity output may be ramped by ramping the power duty cycle of the heater plate, e.g., from 10% to 80%, over a predetermined period.

[0240] After the operational level is reached in step 34, the respirator provides normal operation at the operational level in step 30.

[0241] A second example will be described with reference to Figure 5. The apparatus of Figure 1 is configured to perform the acclimation method of Figure 5 (in addition to other exemplary operations, step 30). This provides one exemplary embodiment of the apparatus and method. This example relates to flow therapy by way of example, but the method and apparatus are not so limited. In this example, humidity is varied. Dew point is a parameter for indicating humidity, but as noted above, this is only one option and similar acclimation can be performed using any other humidity parameter. In this example, both humidity and temperature are varied via heating plate 59 and heater wire 58.

[0242] First, in step 30, the respiratory apparatus 10 provides flow therapy in the normal manner and monitors for a trigger (initiated by the patient or the apparatus) to activate the acclimation process in step 31. The acclimation process is as described in the first example. Next, the controller 19 performs a humidity reduction acclimation operation similar to that described in steps 32 and 33 of FIG. 4.

[0243] Next, the controller 19 performs an acclimation operation 88 to reduce the temperature. This is accomplished by reducing the temperature setpoint (in this example, at the patient end of the hose (EOH)) to an initial comfort level (step 32) and reducing the power to the heater wires 58 under closed-loop control (step 43) to achieve the temperature setpoint. The temperature setpoint, based on the EOH temperature sensor 14, is reduced to a lower temperature. The EOH temperature is reduced by the same "amount" as the chamber outlet setpoint. For example, it may be reduced by about 30% to about 75%. Optionally, the EOH temperature is always set higher than the chamber outlet temperature setpoint, for example, by about 3°C, and the chamber outlet temperature is measured using the chamber outlet temperature sensor 53C. The heater plate power remains reduced until the chamber outlet temperature reaches a lower dew point setpoint (e.g., 25°C). The power to the heater wires 58 is reduced. The EOH temperature is also monitored to ensure it remains above the chamber outlet temperature.

[0244] Next, the controller 19 performs an acclimation operation (step 34) to increase the humidity to the operating level, as described in FIG. 4. The controller 19 also performs an acclimation operation 88 to increase the temperature to the EOH setpoint (operating level) (step 34). The acclimation operation 88 is performed by controlling the heater wire 58. This is performed by gradually transitioning the EOH setpoint temperature from the initial comfort level to the operating level. The controller 19 is configured to control the power of the heater wire 58 under closed-loop control, gradually transitioning the EOH setpoint to the operating level EOH setpoint over the same period. The EOH setpoint is maintained 3°C higher than the chamber outlet temperature setpoint. Alternatively, the ramping period is set shorter than the ramping period of the humidity. That is, the ramp rate is faster than the ramping rate of the HP power. For example, the ramping period of the heater wire may be 50% faster than the HP ramping period. For example, the heater wire power may be ramped to reach the temperature setpoint (operating level) in about 7 minutes to about 30 minutes. The temperature gradient of the heater wire does not exceed the gradient of the heating plate to prevent condensation from forming.

[0245] A third example will be described with reference to Figure 5. The apparatus of Figure 1 is configured to perform the acclimation method of Figure 5 (in addition to other exemplary operations, step 30). This provides an example of an apparatus and method. This example relates to flow therapy, but the method and apparatus are not so limited. In this example, humidity is varied. Dew point is a parameter for indicating humidity, but as noted above, this is only one option and similar acclimation can be performed using any other humidity parameter. In this example, both humidity and temperature are varied via heating plate 59 and heater wire 58.

[0246] This example is similar to the first or second examples, except that no trigger is received during operation. Rather, adaptation begins automatically upon start-up of the respiratory apparatus 10, or upon receiving a manual trigger. This means that no acclimatization actions, such as lowering humidity and / or temperature, are necessary. Rather, only a gradual humidity and / or temperature ramp acclimatization action 88 is required. The controller 19 performs the humidity and / or temperature ramp action at start-up. At start-up, the user selects a dew point setpoint (e.g., a 37°C dew point).

[0247] Alternatively, this acclimation operation may be triggered manually or automatically after an initial warm-up. The water may be heated until the temperature of the heater plate 59 reaches a threshold value. During warm-up, the heater plate 59 is heated as quickly as possible until a target heater plate temperature is reached. Gas flow may not be initiated until the heater plate 59 is warmed up. Alternatively, the flow rate begins and the heater plate 59 is heated as quickly as possible until a warm-up setpoint is reached. The warm-up setpoint is related to the temperature of the heater plate. In yet another form, the warm-up setpoint may be related to the temperature of the gas at the chamber outlet as measured by a chamber outlet temperature sensor.

[0248] The acclimation operation may be initiated manually by the user after the warm-up period is complete. If the patient does not initiate the acclimation method within the predetermined time, the heating plate 59 will heat as quickly as possible to reach the set dew point gas temperature, which is measured by the chamber outlet temperature sensor 53C located at or near the chamber outlet.

[0249] FIG. 6 shows an example of a humidity change pattern during an acclimation period. Before receiving a trigger, the respiratory device is operating at an operating level. For example, this may be a dew point of 37°C. The trigger is activated at time 0, and shortly thereafter, the system reduces the humidity and temperature to reach a comfort level. The reduction is shown as a linear ramp over a period of time. In this example, the period is 20 minutes, but other periods are possible. In other cases, multiple different ramps may be used in successive acclimation operations to reach a comfort level. The comfort level may be maintained at the level for a fixed period of time, such as 5 minutes, 10 minutes, or, as shown, 20 minutes. After sufficient operation or time at the comfort level, the acclimation operation returns the humidity and temperature to the original operating level. Again, the transition between the comfort level and the operating level is shown as a linear or constant ramp. The time to increase the humidity to the operating level may be longer or shorter than the time to decrease the humidity to the comfort level. A longer period may improve the patient's acclimation or adaptation to the operating level.

[0250] Figure 7 shows an example pattern of temperature and humidity change during an acclimation method. The dew point curve shown is similar to Figure 6, but the temperature of the gas stream is also reduced from an operating level to a comfort level. The temperature is shown as decreasing simultaneously with and at the same rate as the humidity. However, in other examples, the temperature and humidity may decrease separately or at faster or slower rates relative to each other.

[0251] FIG. 8 illustrates an example of a humidity change pattern for an acclimation method. FIG. 8 illustrates a stepwise humidity change, where the humidity decreases by a selected or preset amount at each step, followed by a pause and then decreases again. FIG. 8 illustrates a constant step size change from the operating level to the comfort level. However, the step size may vary based on patient preference or system constraints. In returning to the operating level, a first period is a relatively slow increase (large step size) and a second period is a faster increase (small step size). As shown, a shorter step size may be used near the operating level where the patient has acclimated to the change. Alternatively, a shorter step size may be used near the comfort level where the patient is less likely to experience discomfort. In some cases, one or more periods with different step sizes may be used, or the step size may be adjusted in real time based on patient or system feedback.

[0252] Figure 9 shows an example of a humidity change pattern during the acclimation period. While Figure 9 shows a nonlinear humidity change, the overall profile generally follows the linear change shown in Figure 6. However, this is not always the case. For example, oscillations or step-backs may occur near the comfort level or during the ascent to the operating level to increase patient comfort or to facilitate acclimation to the operating level.

[0253] The acclimation method may be applied to other respiratory devices 10 or systems. FIG. 1 illustrates a heated pass-over humidifier. Heated pass-over humidifiers typically have a water volume that decreases as the water evaporates. To achieve humidification of the airflow delivered to the patient, all of the water in the water reservoir is heated. In some cases, the heated pass-over humidifier includes a float. The float is in the water chamber 52. The float is configured to activate a valve to introduce water or other liquid used in the water chamber 52 from the water reservoir into the chamber 52 if the water level falls below a predetermined threshold. This configuration may be configured to maintain a substantially constant water level in the chamber, or to maintain the water level above a predetermined threshold water level.

[0254] Yet another humidification system may be an evaporative humidifier. For example, WO2016036260A1 (incorporated herein by reference) discloses a deterministically controlled humidification system (also referred to as an evaporative humidifier). An evaporative humidifier typically supplies a portion of water (or a suitable liquid) to a heated surface. The amount of water supplied may be controlled or dispensed appropriately. By supplying water to the heated surface, the water is evaporated into a gas stream. The humidified gas stream may then be supplied to the patient. The evaporative humidifier may contain a predetermined amount of liquid and be controlled in a deterministic manner. The amount of liquid is determined to achieve a target humidity. In some cases, the controller may be configured to calculate or retrieve the required amount of liquid. In an evaporative humidifier, the water flow may be controlled to achieve a target humidity, while in a float humidifier, the water flow may be controlled to maintain the amount of water in the chamber.

[0255] 10 shows an example of a respiratory apparatus 10 including an evaporative humidifier form of respiratory humidification system 101. Respiratory humidification system 101 includes a conduit 102 (also referred to herein as a "gas channel," "respiratory conduit," or "inhalation tube") configured to receive gas from a flow generator (not shown) and / or other gas source and direct the gas to an outlet, such as a patient interface 51. In use, gas typically flows from the flow generator to respiratory humidification system 101 (e.g., through conduit 102) and then flows downstream from respiratory humidification system 101 to an outlet or patient interface 51 (e.g., through conduit 102).

[0256] As shown in FIG. 10 , one non-limiting example respiratory humidification system 101 includes a fluid reservoir or water chamber 52 that contains a liquid 104 during use. In this context, “liquid” refers to any liquid or flowable solid suitable for humidifying respiratory gases and may include, for example, water. The liquid 104 may also be water with an additive that is more volatile than water. The water chamber 52 is connected by fluidic or other physical means to a meter or metering device (also referred to herein as a liquid flow controller or water flow controller) 110. The metering device 110 is configured to meter fluid from the fluid reservoir 106 to a heating plate 114 or other system configured to provide a heating surface. The metering device 110 may further include a pump. The pump may be a positive displacement pump, such as a piezoelectric diaphragm pump, a peristaltic pump, a micropump, or a progressive cavity pump. The pump may be a pressure-driven pump, such as a gravity feed connected in series with a control valve. The metering device 110 may include a wicking structure that utilizes capillary action to controllably meter water to a wicking element and / or a heated surface.

[0257] Components of the respiratory apparatus 10 or respiratory humidification system 101 may include a controller 118, which may control components of the respiratory apparatus 10 or respiratory humidification system 101, including, but not limited to, the flow generator, the metering device 110, and / or the heating plate 114. First and second fluid conduits 108, 112 may be configured to communicate fluid to each component of the respiratory humidification system 101. As shown in FIG. 10 , the first fluid conduit 108 may be configured to fluidly communicate fluid from the fluid reservoir 52 to the metering device 110. The second fluid conduit 112 may be configured to fluidly communicate fluid from the metering device 110 to the humidification housing conduit 55 or the humidification housing. The second fluid conduit may include an outlet 116 configured to direct liquid to the heating plate 114. It will be appreciated that various configurations are possible, provided the system is capable of vaporizing a controlled amount of liquid.

[0258] The metering device 110 may be controlled by a water flow controller 118 (which may comprise or be combined with the controller 19 and / or the humidifier controller). The metering device 110 may comprise a pump in an open-loop configuration. The metering device 110 may comprise a pump or flow actuator connected in series with a flow sensor in a closed-loop configuration. Another configuration may use a pump or flow actuator connected in series with a flow sensor in a closed-loop configuration. The water flow controller may configure the metering device to continuously supply water at a rate ranging from 0 mL / min to about 10 mL / min. The metering device 110 may be configured to wet (saturate) the entire surface of the heating plate 114. A fully wet surface allows for more decisive humidity control. A wet surface also means that humidity can be increased more quickly because water moves faster than it would on a dry surface.

[0259] The heating plate 114 may include a suction element configured to distribute a metered amount of liquid across the heating plate 114. In some configurations, the suction element may be configured to draw the metered amount of liquid evenly across the surface of the heating plate 114. The heating plate 114 may be configured to vaporize the metered amount of liquid so that it is entrained in the gas flow of the respiratory therapy system 10 during use. The heating plate 114 may be configured to maintain the heating surface at a predetermined temperature range. The temperature range may be from about 30°C to about 99.9°C.

[0260] Metering device 110 may be configured to supply or distribute fluid to humidifier and / or heating plate 114 at a supply rate that may be considered to increase the moisture content of the gas passing through conduit 55 to reach a predetermined, calculated, or estimated humidity level representative of the level of humidification needed or desired by the patient, while reducing or eliminating the possibility of excessive moisture accumulation within gas channel 102. To control humidification, in some examples, controller 118 may control the supply rate of metering device 110 based on one or more of the following:

[0261] the measured flow rate of gas passing through conduit 55; the measured humidity value corresponding to the humidity of the gas upstream of the humidification housing; a measured pressure level corresponding to the pressure level in the gas channel 102; or A combination of these.

[0262] To control humidification, in one example, the controller 118 may control the dispensing rate of the metering device 110 based on one or more of the following:

[0263] the measured flow rate of gas passing through conduit 55; the measured humidity value corresponding to the humidity of the gas upstream of the humidification housing; the measured flow rate of gas passing through conduit 55; A measured pressure level corresponding to the pressure level in conduit 55.

[0264] The respiratory therapy system 10 or respiratory humidification system 101 may include deterministic or open-loop control using various control systems. In general, deterministic control may allow for on-demand humidification, for example, by controlling the flow of water to a heated surface. In one configuration, the rate of water flow to the heated surface may be controlled based on the gas flow rate in the gas channel. The rate of water flow to the heated surface may be controlled based on the rate of water evaporation from the heated surface. The rate of water flow to the heated surface may be controlled based on the temperature of the heated surface, which may be maintained constant. The rate of water flow to the heated surface may be controlled based on the temperature of the heated surface, which may be controlled. The rate of water flow to the heated surface may be controlled based on the absolute pressure or barometric pressure of the gas near or around the inlet. The rate of water flow to the heated surface may be controlled based on the dew point temperature of the gas at the inlet. The rate of water flow to the heated surface may be controlled based on the enthalpy delivered by the heated surface. The rate of water flow to the heated surface may be controlled based on the power level delivered by the heated surface. The water flow rate to the heated surface may be controlled based on the temperature of the gas at the inlet location. The dew point temperature of the gas at the inlet location may be calculated by processing information provided by the temperature and humidity sensors. The water flow rate to the heated surface may be controlled based on the dew point temperature of the gas at the inlet location. The water flow rate to the heated surface may be controlled based on the relative humidity level of the gas at the inlet location. The water flow rate to the heated surface may be controlled based on the effective heating area of ​​the heated surface. The water flow rate to the heated surface may be controlled based on the pressure level of the gas in the gas channel. The water flow rate to the heated surface may be controlled based on the flow rate of the gas flowing through the gas channel. The water flow rate to the heated surface may be controlled based on the temperature of the water flow. As shown and described in FIG. 1E below, the respiratory therapy system 100 and / or its components (including the respiratory humidification system 101) may be equipped with multiple sensors to measure these variables.

[0265] The system may have various control systems and configurations to achieve humidification. For example, the control system may include a humidification fluid flow control subsystem that monitors and controls the flow rate of fluid metered to the humidification area, and more specifically, to the heater plate 114. A fluid flow sensor measures the flow rate of the humidification fluid and provides the measurement to a fluid flow controller. The controller compares the measured fluid flow rate with a desired fluid flow rate (which may be predefined, estimated, or deterministically calculated) and adjusts the power level to the metering device accordingly.

[0266] In some cases, a preheater may be used before the gas stream is delivered to the heater plate 114. The inlet and preheat control subsystem may use an inlet sensor to measure the air and / or gas entering the system to determine the humidity and pressure of the incoming gas. The gas stream may then be heated in the preheater. An inlet temperature sensor located downstream of the preheater may then measure the temperature of the heated gas and compare it to a calculated temperature set or defined by the controller, and a signal may be sent to the preheater to adjust its temperature accordingly.

[0267] In some cases, a water flow control subsystem may be used. In one embodiment, water enters a water pump from a water supply. The water pump may pump water into the respiratory apparatus 10. A water flow sensor is located downstream of the pump and measures the water flow rate and outputs a value to a liquid flow controller. The liquid flow controller provides a feedback loop whereby the water pump is adjusted based on a comparison of the measured water flow rate with a calculated water flow rate. The calculated water flow rate is determined by the overall system controller.

[0268] In some cases, a hot surface control subsystem may be used. In some cases, the heater plate 114 may be comprised of multiple heater plates, or two heating zones may be provided on a single heater plate. The hot surface controller is activated when the water and air flows pass over the heater plate 114 or heated surface. The heated surface may include one or more surface temperature sensors that measure the surface temperature and send the information to the hot surface temperature controller. The surface temperature controller provides a feedback and control mechanism to regulate the heater plate 114 that constitutes the surface or is thermally coupled to the surface. The surface temperature controller may compare the sensed temperature with a calculated surface temperature. The calculated surface temperature is determined by the humidifier or overall system controller. The humidifier or overall respiratory device controller may receive information from input sensors, including ambient humidity, inlet gas flow rate, inlet gas pressure, and setpoint humidity (e.g., dew point temperature). The overall system may also receive power inputs, such as power supplied to the heated surface and power supplied to the air. These or other inputs may be used to calculate the setpoint temperature and mass flow rate described above.

[0269] In some embodiments, deterministic humidifiers have the advantage that a relatively small amount of water contacts the heater plate 114 at any given time. Therefore, if a change in humidification level is required, the heater plate can change temperature more quickly due to the low thermal resistance of water, thereby decreasing or increasing humidification level more quickly than a pass-through type humidifier.

[0270] The acclimation method may be used in conjunction with a deterministic humidifier configuration. In some cases, this method is advantageous because it leverages more rapid changes in operating level to allow the patient to acclimate faster, or at least transition between levels more quickly. If the controller knows, for example, the gas flow rate and humidity, it may calculate the amount of water vapor to add to achieve a comfort dew point, thereby performing an acclimation operation 88 to reach the comfort target and return to the operating level. The acclimation method may also utilize additional operating parameters of the deterministic humidifier, such as flow rate, to perform the acclimation operation.

[0271] Another embodiment will now be described with reference to Figure 11. The apparatus of Figure 10 is configured to implement the acclimation method of Figure 11 (and other typical operating parameters, step 30). This example relates to flow therapy by way of example, but the method and apparatus are not so limited. In this embodiment, humidity is varied by controlling at least one of water flow rate and heating plate power. While dew point is a parameter for indicating humidity, as noted above, this is only one option and similar acclimation can be implemented using any other humidity parameter.

[0272] First, in step 30, the respiratory apparatus 10 delivers flow therapy in the normal manner. It also monitors for a trigger (initiated by either the patient or the apparatus) (step 31). When a trigger is received, the method initiates the acclimation method described above. In this example, acclimation involves ramping the humidity from an initial comfort level to an operating level to allow the user to better acclimate to the humidity at a particular flow rate. The controller 19, 118 then performs an acclimation operation 88, which controls the dew point at the water chamber outlet using closed-loop control to reduce humidity. To perform the acclimation process, the controller 19, 118 is configured to determine a lower dew point setpoint (initial comfort level humidity gas flow parameter) in step 32. For example, the new dew point may be in the range of about 30% to about 75% lower than the current dew point, or any other value previously described.

[0273] The controller 19, 118 then decides how to perform the adaptation action, which may include one or more of the following:

[0274] Reducing the water flow rate (step 35); Activation of the heating plate 114 (step 36), and Reducing the power supplied to the heater plate 114 (step 36).

[0275] For example, to reduce power output, the duty cycle to the heater plate 59 may be reduced. Alternatively, power to the heater plate 59 may be completely shut off. Alternatively, the voltage or current to the heater plate 59 may be shut off. Optionally, the heater plate power may be shut off to reduce the dew point as quickly as possible. Power to the heater wire 58 may be maintained at the same limit. Feedback is still based on the EOH (end of hose) temperature sensor 14, which uses 37°C as the setpoint. This ensures that condensation in the conduit 55 is prevented or reduced. The water flow rate may be controlled, for example, by the metering device 110. The water flow rate may be controlled independently of or in conjunction with changes in flow rate and / or temperature. An appropriate water flow rate to reach a comfort level or to perform an acclimation operation may be determined based on the gas flow model. The water flow rate may be increased or decreased to ensure patient comfort or to facilitate acclimation to the operating level. The acclimation operation 88 continues until a comfort level is reached (step 37). For example, to reduce humidity, the water flow rate to the heater plate 114 may be reduced. Reducing the amount of water on the heater plate reduces the amount of water that evaporates into the gas stream, thus reducing humidity. As another example, the temperature of the heater plate 114 may also be controlled.

[0276] The controller 19, 118 then performs an acclimation operation 88 to ramp the respiratory apparatus 10 back up to the operating level (step 34). The controller 19, 118 is configured to control one or more of the heater plate 114 and metering device 110 to ramp the operating level of the water flow rate 38 and / or heater plate output (temperature) 39. This is accomplished by ramping the dew point from a lower setpoint (initial comfort level) back to the user setpoint (operating level). For example, the controller 118 may control the output to the heater plate 114 using the above control method or other methods, such that the dew point temperature rises from an initial comfort level of approximately 25°C to the operating level of approximately 37°C within a predetermined time (or at a predetermined ramp rate). The water flow rate may increase with the temperature. In some cases, the ramps may be offset or staggered to reduce substantial changes in the operating level in the patient. For example, the time period may be between 15 minutes and 1 hour, and optionally between 30 and 45 minutes. After the operating level is reached, the breathing apparatus provides normal operation at the operating level (step 30).

[0277] In some cases, the use of a deterministic humidifier system facilitates control of water flow rate in addition to heating plate power. In either case, additional parameters (e.g., gas flow rate and / or pressure) may be controlled. The rate of change from the operating level to the comfort level (or vice versa) may be increased or more precisely controlled by using a deterministic humidifier system (or other suitable humidifier system). This is because the humidification process can be more precisely controlled using the metering device 110. In some cases, the duration of the transition to the comfort level or the time frame between the comfort level and the operating level (or between the operating level and the comfort level) may be more precisely controlled. For example, the transition may be controlled over a predetermined period of time. In some cases, patient comfort may be monitored during the transition (e.g., by tracking the triggering of additional comfort responses or by monitoring mask removal), and the transition may be modified to increase comfort. For example, slowing the transition may improve comfort.

[0278] In some cases, for example, reducing from the operating level to the comfort level includes reducing the water flow rate to a level required for the comfort level. In some cases, the power of the heating plate 114 is reduced. The power may be reduced simultaneously with, before, or after the water flow rate. In one example, the transition time (i.e., acclimatization operation) for reducing the dew point temperature from 38°C to 34°C (constant flow rate) is approximately 2 minutes. Example transitions between the operating level and the comfort level may have a duration of up to 20 minutes, up to 10 minutes, approximately 2 minutes, or approximately 5 minutes. In some cases, the transition period is approximately 10 minutes, for example, to reduce the likelihood of an overheating condition. In some cases, the transition period may be 5 to 20 minutes, 5 to 15 minutes, or 5 to 10 minutes. One or more of the control or acclimatization methods described above may be applied to different humidification systems, such as deterministic humidifiers. These alternative humidifiers may have additional operating parameters to be controlled, such as water flow rate.

[0279] The acclimatization methods have been described with a focus on controlling humidity and / or temperature of the respiratory device. However, the methods and systems described herein may be applied to any operating parameter, as desired, such as humidity and / or temperature, flow rate, pressure, or gas concentration. For example, if the patient is not accustomed to a high flow rate or if supplemental oxygen is added (or decreased), the system may increase or decrease the flow rate or supplemental oxygen flow rate between the comfort level and the operating level. This may improve patient comfort and, consequently, adherence.

[0280] In some cases, humidity and flow rate may be ramped to allow the patient to acclimate to the higher humidity and gas flow rate in the system. This may facilitate transitions in changes to gas delivery to the patient based on changes in therapy. In other examples, flow rate and / or pressure may be ramped independently of humidity. In some cases, flow rate may be ramped or changed along with other operating parameters, potentially improving patient comfort. For example, because higher flow rates typically require higher humidity, these parameters may be ramped together (simultaneously or alternately) to make the ramp to operating levels more comfortable.

[0281] One or more of the following advantages may be achieved: The acclimation method may acclimate the patient to the operating parameters (e.g., humidity and / or temperature) over a period of time from an initial comfort level to the operating level. As the parameters are ramped up, the patient tolerates each increase (acclimates to each level) and remains comfortable during the acclimation period. By the time the operating level is reached, the patient is able to tolerate the operating parameters even if they could not initially. Because the patient can tolerate the operating level of the operating parameters, they are more likely to use the respiratory device as directed and may also be more compliant with the therapy provided by the respiratory device.

[0282] A typical use case would be when a patient is using a respiratory device and is being provided with a gas flow with operating parameters (such as humidity and temperature) at a certain operating level. The patient may find this operating level of parameters uncomfortable, so an acclimatization method is activated, lowering the parameters to a tolerable initial comfort level and then ramping them up to the operating level. At that point, the patient can tolerate the exertion level and continue operating normally. However, other use cases are possible, and this acclimatization method can be used at any convenient time.

[0283] Some example results are as follows:

[0284] Improved patient comfort in flow therapy where heated and humidified gas flow, especially fully saturated gas, can cause patient discomfort. Gas is optionally fully saturated to make high flow rates comfortable and tolerable.

[0285] The user adapts to flow therapy with a fully saturated gas flow.

[0286] · Increased compliance with treatment due to user adaptation.

[0287] The occupant has a control that allows them to initiate acclimatization at any time, which improves compliance as the occupant can control the humidity and / or temperature provided.

[0288] If patient compliance is deemed low, such as when the patient interface is removed, an acclimatization action (e.g., humidity ramp) is automatically initiated. This should help improve patient compliance.

[0289] Flow rates may be maintained at set points, allowing the flow therapy mechanism to continue even in low humidity conditions.

[0290] Acclimatization can be beneficial if the patient is receiving high-flow therapy while sleeping. This acclimatization method may be activated before sleep and may facilitate compliance as the patient enters the sleep state.

[0291] Aspects of the controllers and methods described above may be operable or implemented on any type of special purpose or specialized computer, machine, computer, server, or electronic device having a microprocessor, processor, microcontroller, programmable controller, etc., or on a cloud-based platform, other local or remote network of processors and / or servers, or any combination thereof.

[0292] The controllers described in connection with the embodiments disclosed herein may be implemented or performed by a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other programmable logic component, individual gate or transistor logic, individual hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, circuit, and / or state machine. A processor may also be implemented as a combination of computing components, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration.

[0293] The methods or algorithms described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a processor-executable software module, or a combination thereof, in the form of a processing unit, programming instructions, or other instructions, and may be contained in a single device or distributed across multiple devices. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. The storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. Alternatively, the storage medium may be integral to the processor.

[0294] In its various aspects, embodiments of the present disclosure may be embodied in a computer-implemented process, a machine (such as an electronic device, or general-purpose computer, or other apparatus providing a platform on which a computer program can be executed), a machine-performed process, or an article of manufacture, including a computer program product or digital information product having a computer-readable storage medium containing computer program instructions or computer-readable data stored thereon, as well as processes and machines for making and using these articles of manufacture.

Claims

1. 1. A breathing apparatus comprising: a flow generator for providing a gas flow; a humidifier for humidifying the gas stream; by reducing one or more of the humidity and temperature of the gas stream from an operational level to a comfort level; and by increasing one or more of the humidity and the temperature of the gas stream from the comfort level to the operating level over a first period of time; a controller configured to operate the respiratory assistance device for acclimatization; A breathing apparatus comprising:

2. 10. The respiratory apparatus of claim 1, wherein the humidity and / or temperature of the gas stream is at an operational level prior to reducing the humidity and / or temperature of the gas stream.

3. 3. The respiratory apparatus of claim 1, wherein increasing one or more of the humidity and the temperature of the gas flow comprises ramping one or more of the humidity and temperature over the first period of time.

4. 10. A respiratory apparatus as claimed in any preceding claim, wherein the duration of the first period of time is determined before reducing the humidity and / or temperature of the gas flow.

5. the duration of the first period calculated at a rate of approximately 1°C / 5 minutes to ramp from an initial comfort level to the operating level (e.g., from a 31°C dew point to a 37°C dew point in approximately 30 minutes); for at least about 10 minutes, - for at least about 15 minutes, - for at least about 30 minutes, - about 30 minutes to about 40 minutes, - Approximately 35 minutes, - for at least about 40 minutes, - Approximately 45 minutes, - about 30 minutes to about 50 minutes, - about 30 minutes to about 60 minutes, - about 35 minutes to about 1 hour, - at least about 1 hour, - about 1 hour to about 2 hours, or - Maximum approx. 2 hours 10. A breathing apparatus according to any preceding claim, wherein:

6. Before reducing the humidity and / or the temperature of the gas stream, the humidity and / or the temperature of the gas stream is: for at least about 10 minutes, - for at least about 15 minutes, - for at least about 30 minutes, - about 30 minutes to about 40 minutes, - Approximately 35 minutes, - for at least about 40 minutes, - Approximately 45 minutes, - about 30 minutes to about 50 minutes, - about 30 minutes to about 60 minutes, - about 35 minutes to about 1 hour, - at least about 1 hour, - about 1 hour to about 2 hours, or - Maximum approx. 2 hours 10. A breathing apparatus as claimed in any preceding claim, which is at an operational level for

7. 10. A respiratory apparatus according to any preceding claim, wherein the operating level of humidity is a dew point of about 31°C, 34°C or 37°C at 100% RH.

8. 10. A respiratory apparatus as claimed in any preceding claim, wherein the comfort level comprises humidity 3°C below the operating dew point level.

9. 10. A respiratory apparatus as claimed in any preceding claim, wherein the humidifier is controlled to reduce or increase one or more of the humidity and the temperature.

10. 10. Respiratory apparatus according to any preceding claim, wherein the humidifier comprises a heating plate configured to heat water so as to humidify the gas flow.

11. 10. A breathing apparatus as claimed in any preceding claim, comprising a breathing conduit, said breathing conduit comprising a heater wire.

12. 12. A respiratory apparatus as claimed in claim 11, wherein the heater wire is coupled or coupleable to an outlet of the humidifier.

13. A respiratory apparatus according to any one of claims 10 to 12, wherein one or more of the humidity and temperature are reduced or increased by controlling one or more of the heating plate and heater wire.

14. one or more of the humidity and the temperature of the gas stream; an inlet of the humidifier; The interior of the humidifier; an outlet of the humidifier; respiratory conduit, an inlet of said breathing conduit; an outlet of the breathing conduit; patient interface, an inlet for the patient interface; and an outlet of the patient interface 14. A breathing apparatus according to any preceding claim, wherein the sensing is performed at one or more of the following locations:

15. the humidity of the gas stream is indicated by a humidity parameter; 10. Respiratory apparatus according to any preceding claim, wherein the temperature of the gas flow is indicated by a temperature parameter.

16. The humidity parameter is relative humidity, Absolute humidity, and dew point 16. The respiratory apparatus of claim 15, wherein:

17. The temperature parameter is the temperature of the gas stream, the temperature of the heating plate, and Heater wire temperature 17. A breathing apparatus as claimed in claim 15 or 16, wherein:

18. one or more humidity and / or temperature sensors, an inlet of the humidifier; The interior of the humidifier; an outlet of the humidifier; respiratory conduit, an inlet of said breathing conduit; an outlet of the breathing conduit; patient interface, an inlet for the patient interface; and an outlet of the patient interface 10. A breathing apparatus according to any preceding claim, further comprising at one or more locations:

19. The controller: receiving input from a user; Internal triggers, and Activation of the breathing apparatus 10. A respiratory apparatus according to any preceding claim, configured to operate the respiratory assistance apparatus for patient comfort by one or more of:

20. 10. A respiratory apparatus according to any preceding claim, including a metering device configured to control the water flow rate in the humidifier.

21. 21. The respiratory apparatus of claim 20, wherein one or more of the humidity and the temperature are reduced or increased by controlling one or more of the heating plate, heater wire, and metering device.

22. 10. A respiratory apparatus according to any preceding claim, wherein the step of reducing one or more of the humidity and / or temperature of the gas flow from an operating level to a comfort level is carried out over a second period of time, optionally said second period of time being up to 1 hour, up to 30 minutes, up to 20 minutes, 5-15 minutes, or about 10 minutes, or less than 5 minutes.

23. 10. A respiratory apparatus according to any preceding claim, wherein one or more of the humidity and the temperature transition in a ramp over the first period of time, optionally the ramp being linear, stepwise or non-linear.

24. 24. A respiratory apparatus as claimed in claim 23, wherein the ramp rate is predetermined.

25. 10. A respiratory apparatus according to any preceding claim, wherein the humidifier comprises a heated pass-over humidifier, a heated pass-over humidifier with a float, or an evaporative humidifier.

26. 10. A respiratory apparatus according to any preceding claim, comprising the steps of determining whether a user has removed a patient interface, and deciding whether to perform the acclimatization based on a determination that the patient interface has been removed, optionally wherein determining whether to perform the acclimatization comprises determining one or more of the number of times or length of time that the patient interface has been removed.

27. 10. A breathing apparatus as claimed in any preceding claim, wherein the comfort level comprises a dew point that is 30% to 75% lower than the operating level.

28. 10. A respiratory apparatus as claimed in any preceding claim, wherein one or more acclimatisation operations are used to increase or decrease one or more of the humidity and the temperature of the gas stream.

29. 10. A respiratory apparatus according to any preceding claim, wherein the apparatus includes a user interface, the user interface being configured to enable the user to activate an acclimatization action, optionally the user interface comprising a button or a touch screen.

30. 30. A respiratory apparatus according to claim 29, comprising selecting each of one or more accommodation actions based on a determination of current patient comfort, optionally said patient comfort determined by one or more of: user interface removal and activation of the accommodation button.

31. The controller by decreasing the flow rate of the gas stream from the operating level to the comfort level; and increasing the flow rate of the gas stream from the comfort level to the operating level over a first period of time; 10. A breathing apparatus according to any preceding claim, configured to operate the breathing assistance apparatus for acclimatization.

32. 32. The respiratory apparatus of claim 31 , wherein the decreasing the flow rate and the increasing the flow rate occur simultaneously with decreasing one or more of humidity and temperature and increasing one or more of temperature, respectively.

33. 33. A respiratory apparatus as claimed in claim 32, wherein the reducing the flow rate and the reducing one or more of humidity and temperature are performed separately.

34. A respiratory apparatus according to any one of claims 29 to 33, wherein the operating level is a high flow therapy level.

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