Comfort for respiratory apparatus
The respiratory apparatus adjusts operating parameters over multiple sessions based on prior data to enhance comfort and efficacy, addressing the need for dynamic parameter adjustment in existing systems.
Patent Information
- Application Number
- PCT/IB2025/056474
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-25
- Filing Date
- 2025-06-25
- Publication Date
- 2026-01-02
AI Technical Summary
Existing respiratory apparatus lack effective methods to adjust operating parameters, such as humidity levels, over multiple sessions to enhance patient comfort and therapeutic efficacy.
A respiratory apparatus with a controller that adjusts operating parameters, like humidity, based on prior session data to gradually transition from initial to desired levels over multiple sessions, considering factors like patient adherence and comfort.
Enhances patient comfort and therapeutic efficacy by optimizing operating parameters over time, adapting to patient needs and improving adherence.
Smart Images

Figure IB2025056474_02012026_PF_FP_ABST
Abstract
Description
COMFORT FOR RESPIRATORY APPARATUSFIELD OF THE INVENTION
[0001] The present disclosure relates to respiratory apparatus and their method of use to assist with patient comfort.BACKGROUND TO THE INVENTION
[0002] Respiratory apparatus are used in various environments such as hospital or medical facilities (generally termed "hospital" environment, which covers any facility with trained medical staff) or residential care or home environments (generally termed "home" environment and may not have trained medical staff) to deliver a flow of gases to patients. A respiratory apparatus generally provides air and / or may be used to deliver supplementary oxygen or other gases with a flow of gases, and / or a humidification apparatus to deliver heated and humidified gases. A respiratory apparatus may allow control over parameters of the gases flow, comprising but not limited to flow rate, pressure, gases concentration, humidity and temperature.SUMMARY OF INVENTION
[0003] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more humidification parameters, and a controller configured to control the humidifier, wherein the controller is configured to: obtain one or more prior humidification parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more humidification parameters based on the one or more prior humidification parameters, and set the one or more humidification parameters of the humidifier.
[0004] As described below, the present disclosure may be applied to humidity or another operating parameter of the respiratory apparatus. Although they may be described inrelation to humidity the following options may be applicable to any operating parameter. Therefore 'humidity' or 'humidification' may optionally be replaced by 'operating', 'operating parameter' or 'operational' in some examples. Example operating parameters include flow rate, pressure, gases concentration, humidity, time and temperature.
[0005] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the humidifier, wherein the controller is configured to: obtain one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more operating parameters based on the one or more prior operating parameters, and set the one or more operating parameters of the humidifier. In some cases the one or more operating parameters comprise one or more humidification parameters. In some cases the one humidification parameter comprises a humidification level.
[0006] In some cases the one or more operating parameters and / or the one or more prior operating parameters comprise any one or more of: a humidification set point, a desired humidification level, a delivered humidity, a maximum previously reached set point, and / or a time above a humidification level. In some cases the one or more prior operating parameters comprise a prior operating parameter level or a prior humidification level. In some cases the one or more prior operating parameters comprises timing data from one or more previous operating sessions. In some cases timing data comprises a length of one or more previous operating sessions and / or a length of one or more parts or operating parameter settings of one or more previous operating sessions. In some cases the timing data comprises an elapsed time since a first operating session. In some cases the one or more operating parameters are the same parameters as the one or more prior operating parameters. In some cases the one or more operating parameters are configured to increase the humidity of the flow of gases over the therapy session.
[0007] In some cases the one or more operating parameters comprise a multi-session operating parameter transition. In some cases the controller is configured to determinea multi-session operating parameter transition based on the one or more operating parameters. In some cases the multi-session operating transition is between an initial operating parameter level and a desired operating parameter level, or an operational parameter level. In some cases the initial operating parameter level is a comfort operating parameter level. In some cases the desired operating parameter level is a therapeutic operating parameter level. In some cases the desired operating parameter level is selectable by a clinician. In some cases the initial operating parameter level and / or the desired operating parameter level are humidification set points of the humidifier. In some cases the initial operating parameter level and / or the desired operating parameter level are delivered humidities of the humidifier. In some cases the delivered humidity comprises a humidity of the flow of gases leaving the humidifier.
[0008] In some cases the initial operating parameter level is less than, or the same as, the desired operating parameter level of an immediately prior operating session and / or the maximum operating parameter of the immediately prior operating session. In some cases the initial operating parameter level is modified based on an adherence parameter of the immediately prior operating session. In some cases the initial operating parameter level is lowered if an adherence parameter shows poor adherence at the operating parameters of the prior operating session. In some cases the operating parameter transition comprises a modification of the one or more operating parameters from the one or more prior operating parameters to or towards one or more desired operating parameters.
[0009] In some cases the modification of the one or more desired operating parameters comprises an increase from the one or more prior operating parameters. In some cases the increase comprises an increment. In some cases the increment is predefined. In some cases the session operating parameter transition comprises an increment in the one or more prior humidification parameters.
[0010] In some cases the increment is the same as a prior increment of the one or more prior operating parameters. In some cases the increment is modified from the prior increment of the one or more prior operating parameters. In some cases the time period of the increment is modified from the prior increment. In some cases the size of theincrement is modified. In some cases the modification is dependent on an adherence parameter of the one or more prior operating sessions. In some cases the increment is configured to be set by a clinician. In some cases the increment is dependent, at least in part, on an adherence parameter of the one or more prior operating sessions. In some cases the increment occurs at the start of a session. In some cases the increment occurs during a session.
[0011] In some cases a multi-session operating parameter transition is specified over a plurality of operating sessions. In some cases the plurality of operating sessions comprises a fixed number of operating sessions and / or a variable number of operating sessions.
[0012] In some cases the controller is configured to determine the session operating parameter transition based on a multi-session operating parameter transition defined for a plurality of operating sessions. In some cases the multi-session operating parameter transition is configured to increase the one or more operating parameters to one or more desired operating parameters over a predefined number of sessions. In some cases the multi-session operating parameter transition comprises a plurality of session operating parameter transitions, the plurality of session operating parameter transitions combining to form the multi-session operating parameter transition.
[0013] In some cases the multi-session operating parameter transition comprises a predefined period of time. For example, the multi-session operating parameter transition may be defined over a predefined period of hours. For example, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 25, 40, 45, 50, 70, 80, 90 or 100 hours. The predefined period may be between 4 and 100 hours. The predefined period of hours may occur over multiple operating sessions of the respiratory apparatus. The operating sessions may range in length of time. However, the multi-session operating parameter transition may be independent of the number of sessions. In some cases the initial operating parameter of a session is equal to the final operating parameter of the previous operating session. In some cases the operating parameter is determined solely on the elapsed time of the previous operating sessions.
[0014] In some cases the multi-session operating parameter transition comprises one or more partial operating parameter transitions. In some cases the partial operating parameter transition defines initial and desired operating parameters and / or a profile between initial and final operating parameters. In some cases the partial operating parameter transition has a predefined time period. In some cases the predefined timeperiod is approximately an expected session length.
[0015] In some cases, a predefined period of time comprises a time of use of the respiratory apparatus. In some cases, the time of use is determined, at least in part, by detection of a patient connected to the respiratory apparatus. In some cases one or more sensors are configured to detect a patient connected to the respiratory apparatus. In some cases the sensors comprise one or more of a patient interface sensor, a patient presence sensors and / or pressure and / or flow rate sensors. In some cases, the time of use is determined, at least in part, by an operating time of the respiratory apparatus. In some cases, the time of use is determined, at least in part, by user input. The user input may be patient or clinician input.
[0016] In some cases each of the session operating parameter transitions comprise an increase from an initial session operating parameter level to a desired session operating parameter level. In some cases the initial session operating parameter level increases in each later session operating parameter transition. In some cases the desired session operating parameter level increases in each later session operating parameter transition. In some cases an initial session operating parameter level of each session operating parameter transition increases for each session operating parameter transition of the multi-session operating parameter transition. In some cases the desired session operating parameter level of each session operating parameter transition increases for each session operating parameter transition of the multi-session operating parameter transition. In some cases the initial session operating parameter level is less than the desired session operating parameter of the immediately prior session operating parameter transition. In some cases at least one session operating parameter transition is repeated in two or more consecutive sessions. In some cases a rate of the increase between the initial session operating parameter level and the desired session operatingparameter level is constant. In some cases a rate of increase between the initial session operating parameter level and the desired session operating parameter level reduces and / or increases over the session. In some cases the size of the increase between the initial session operating parameter level and the desired session operating parameter level is the same as in one or more, or all, of the prior sessions. In some cases a rate of increase between the initial session operating parameter level and the desired session operating parameter level is the same as in one or more, or all, of the prior sessions.
[0017] In some cases the increase between the initial session operating parameter level and the desired session operating parameter level comprises one or more steps. In some cases each session operating parameter transition has a fixed time period. In some cases each session operating parameter transition has a variable time period. In some cases the time period comprises any one or more of: an operating session, less than an operating session, at least 30 minutes, at least 60 minutes, at least 90 minutes, at least 120 minutes, at least 150 minutes, or at least 180 minutes. In some cases the time period is determined based on the one or more prior operating parameters. In some cases the time period is determined based on the length of one or more prior sessions. In some cases the time period is a minimum, maximum and / or average of the length of the one or more prior sessions. In some cases the session operating parameter transition comprises a session operating parameter profile.
[0018] In some cases each of the plurality of session operating parameter transitions, which make up the multi-session operating parameter transition, have a predefined time period. In some cases the session operating parameter transitions are applied for the predefined time period, where the time period may be completed in multiple uses of the respiratory apparatus. In some cases each session operating parameter transition is applied to a single use of the respiratory apparatus.
[0019] In some cases the controller is configured to receive an input of one or more input operating parameters. In some cases the one or more operating parameters comprise the one or more input operating parameters. In some cases the input is received over a communications channel. In some cases the communications channel is between the respiratory apparatus and a server and / or a remote processor. In some cases thecommunications channel is between the respiratory apparatus and a personal electronic device. In some cases the input is received through an application on the personal electronic device. In some cases the input is received from a user interface. In some cases the input operating parameters comprise a operating parametertransition. In some cases the operating parameter transition comprises one or more initial operating parameters and one or more desired operating parameters. In some cases the multi-session operating parameter comprises a operating parameter transition profile and / or one or more session operating parameter transition profiles.
[0020] In some cases the controller is configured to receive an input of one or more comfort parameters. In some cases the comfort parameter indicates a patient discomfort. In some cases the controller is configured to adjust one or more of the operating parameters based on the one or more comfort parameters. In some cases one or more of the operating parameters are reduced. In some cases the controller is configured to increase the operating parameter over a time period after the reduction. In some cases the increase in the operating parameter is to a desired operating parameter. In some cases the increase in the operating parameter is to a value below the desired operating parameter. In some cases the controller is configured to lower a desired operating parameter on receiving the one or more comfort parameters. In some cases the controller is configured to adjust the rate of increase of the one or more operating parameters on receiving the one or more comfort parameters. In some cases the rate of increase is lowered. In some cases the change in the operating parameter is determined based on one or more of: the desired session operating parameter level, the initial session operating parameter level, and the operating parameter level when the comfort parameter was received.
[0021] In some cases the desired operational parameter of the multi-session operating parameter transition is adjusted based on the indication of discomfort. In some cases the multi-session transition is adjusted to meet the adjusted desired operating parameter in the same number of sessions. In some cases the increment or rate of change of the operating parameter is maintained and the number of sessions may be reduced. In somecases one or more future initial session operating parameters are at least partially adjusted to accommodate the adjustment in the desired operating parameter.
[0022] In some cases the respiratory apparatus is configured to provide a pressure therapy mode. In some cases the controller is configured to apply an operating parameter therapy transition when moving between a pressure therapy mode and a high flow mode. In some cases the controller is configured to apply an operating parameter transition in both the pressure therapy mode and the high flow mode. In some cases the operating parameter therapy transition comprises an initial operating parameter level at or near the pressure therapy mode operating parameter and a target operating parameter level at a high flow therapy operating parameter level.
[0023] In some cases one or more of the operating parameters of the pressure therapy mode are dependent on the operating parameters of the high flow mode. In some cases the operating parameters are a fixed portion of, or value beneath the high flow mode. In some cases the pressure therapy mode comprises an operating parameter transition. In some cases this is independent from the high flow mode. In some cases a prior session operating parameter is determined for the pressure therapy mode separately to the high flow therapy mode.
[0024] In some cases the controller is configured to determine, from the one or more prior operating or operating parameters, any one or more of: a type of operating of a prior session, an elapsed time of a multi-session operating parameter transition, a length of one or more prior session, a minimum, maximum, initial, final or average operating parameter set point or a humidity output of the one or more prior sessions, and one or more events during one or more prior sessions.
[0025] In some cases the controller is configured to determine an elapsed time of a multi-session operating parameter transition and continue the multi-session operating parameter transition from that elapsed time point.
[0026] In some cases the controller is configured to determine a time period from the beginning of the prior session until the event. In some cases the controller is configured to control the operating parameter based on the determined time period. In some cases the controller is configured to modify an operating parameter before the determinedtime period has elapsed in the current operating session. In some cases the controller is configured to reduce the one or more operating parameters before time period has elapsed in the current operating session. In some cases the controller is configured to adjust the time period of a session operating parameter transition based on the determined time period. In some cases the event is determined by one or more of: removal of a patient interface, unexpected ending of the prior operating session, patient inputs during the prior operating session, flow rate changes, operating parameter changes, water levels.
[0027] In some cases the one or more operating parameters are also dependent, at least in part, on one or more of: humidifier flow rate; humidifier water level; time of day; and therapy settings.
[0028] In some cases the controller is configured to determine the time of day of the one or more prior operating sessions. In some cases the controller comprises a clock configured to determine the time of day. In some cases the controller is configured to determine if the prior operating session was an overnight session based on the time of day of the prior operating session. In some cases an overnight session is a session occurring, in part, between at least the hours of 12am and 1 am. In some cases a sleep schedule is used to determine a day or night session. In some cases the controller is configured to determine a session length based on the time period of the determined overnight session. In some cases the controller is configured to determine the one or more operating parameters based on the length of the determined overnight session. In some cases one or more parameters of the session operating parameter transition is altered dependent, at least in part, on the time of the session. For example a session during the day may comprise a smaller change in operating parameter (i.e., between initial and desired operating parameter) than a night session. In some cases one or more of the: size of a change, rate of change, length of transition may be altered between a day and a night session. In some cases a desired operating parameter is altered between day and night sessions. For example, a lower desired operating parameter level may be used during a night session due to lower tolerance of a patient and / or water conservation.
[0029] In some cases one or more parameters of the session operating parameter transition is altered dependent, at least in part, on the type of session. A type of session may refer to a time, location, season, or reason for the session, or other factors. In some cases a first type of session comprise a smaller change in operating parameter (or no change in parameter) than a second type of session). In some cases one or more of the: size of a change, rate of change, length of transition may be altered between first and second types of session. In some cases a desired operating parameter is altered between different session types. In some cases three, four or more types of session are specified.
[0030] In some cases the controller is configured to determine a water level of the humidifier. In some cases the controller is configured to determine the one or more operating parameters based on the determined water level. In some cases the controller is configured to determine the one or more operating parameters based on the determined water level and a predicted session length. In some cases the controller is configured to set the one or more operating parameters to provide a time period at a desired session operating parameter level at the end of a therapy session. In some cases the time period is 15 minutes, 30 minutes, 45 minutes or 1 hour.
[0031] In some cases the controller is configured to determine an apparatus parameter. In some cases the apparatus parameter is detected by a sensor. In some cases the sensor comprises one or more of a flow sensor or pressure sensor. In some cases the apparatus parameter is indicative of an operation of the apparatus and / or a patient action. In some cases the parameter is indicative of any one or more of: a patient wearing the patient interface, a patient beginning therapy, a patient adherence to the apparatus; a patient ceasing therapy; and a patient removing a patient interface. In some cases the controller comprises a user interface to prompt the patient to identify a reason for removing the patient interface. In some cases the controller is configured to record one or more operating parameters when the user interface is removed.
[0032] In some cases the controller comprises a user interface to prompt the patient to identify one or more of the start and end of therapy. In some cases a session is defined based, at least in part, on a determination that the patient is receiving therapy. The determination may be made by one or more of: a patient input, detection of a patient; iodetection of a patient wearing a patient interface or other detection device. In some cases the transition is stopped if the patient is detected to not be wearing the patient interface. In some cases the transition is continued only when the patient interface is worn and / or where the patient is detected to be wearing the patient interface. In some cases the controller does not start a transition until the patient is detected to be wearing the patient interface. In some cases the controller is configured to prompt the patient to wear the patient interface after completion of a non-therapeutic mode. In some cases the controller will not begin, or restart, a transition or session after a non-therapeutic mode until the patient is detected to be wearing the patient interface and / or receiving the flow of gases.
[0033] In some cases the controller is configured to record the one or more operating parameters set by the controller. In some cases the recorded one or more operating parameters are configured to be available to a future apparatus session. In some cases the one or more operating parameters comprise environmental parameters. In some cases the operating parameter comprise an ambient temperature and / or humidity. In some cases the controller is configured to control the flow rate of the flow of gases based on the one or more operating parameters. In some cases the controller is configured to control a flow rate of the flow of gases. In some cases the flow rate is controlled by one or more of a valve and / or a blower. In some cases the controller comprises a memory configured to store the one or more operating parameters. In some cases the prior operating session comprises a time period between switching on the respiratory apparatus and switching off the respiratory apparatus.
[0034] In some cases the prior operating session comprises aggregated use of the respiratory apparatus over a time period. In some cases the time period is 24 hours or 12 hours. In some cases the prior operating session comprises a therapeutic session. In some cases the therapeutic session comprises a minimum time period defined by a clinician. In some cases the therapeutic session comprises a minimum time period of: at least 2 hours, at least 3 hours, at least 4 hours, at least 6 hours, at least 8 hours, at least 10 hours, and overnight.
[0035] In some cases the controller is configured to detect an incomplete session which is ended before the desired session operating parameter level is reached. In some cases the controller detects a patient stopping the session and / or a patient removing the patient interface. In some cases the controller is configured to modify the multi-session operating parameter transition based on the incomplete session. In some cases the controller is configured to: repeat the incomplete session; increase the rate of parameter increase in the following session; increases the number of sessions; move directly to the next session and / or begin the next session at the operating parameter level at the time the incomplete was stopped.
[0036] In some cases the controller is configured to modify the multi-session operating parameter transition. In some cases the modification is due to one or more of adherence, session parameters (e.g. number, length, time between), patient or clinician input, or other factors. In some cases the patient input comprises an indication of discomfort. In some cases the modification is a response action to an indication of discomfort. In some cases the modification increases or decreases one or more of: the number of sessions, the length of sessions, the increase of the parameter within a session; the profile of the increase of the parameter within the session; the increment between sessions; the desired operating parameter; the length of the current or future sessions; the comfort operating parameter and / or the response to user input. In some cases the modification stops the session transition and / or the multi-session transition. In some cases the modification is a temporary pause. In some cases the modification is a repeat of the current or a previous session. In some cases the controller is configured to apply the modification automatically. In some cases the controller receives the modification from a clinician and / or the modification is authorised by a clinician. In some case the modification (e.g. the size of the modification) is dependent on a difference between the current operating parameter and the desired operating parameter, and / or the desired session operating parameter. In some cases the modification (e.g. the size of the modification) is dependent on the number of previous modifications. In some cases subsequent modifications are smaller than prior modifications. In some cases modifications are limited by clinician settings. In some cases modifications are reported to a clinician.
[0037] Although the description discusses operating parameters being increased it is clear that, in some cases, operating parameters may decrease for comfort. Any discussion of increasing parameters should be understood to also cover decrease or change in parameters if applicable.
[0038] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases to a patient, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the respiratory apparatus, wherein the controller is configured to: obtain one or more desired operating parameters for delivering therapy to the patient; obtain one or more initial operating parameters forthe patient; determine a multi-session humidification transition configured to increase the initial operating parameters to the desired operating parameters over a plurality of sessions. There are different methods for the respiratory apparatus to determine the operating parameter modification. The modification may be determined based on prior settings, loaded based on an input or based on preset values. The optional features according to the other claims may be applied to this respiratory apparatus.
[0039] In some cases the multi-session humidification transition comprises a plurality of session humidification transitions, the plurality of session humidification transitions in combination configured to increase the initial operating parameters to the desired operating parameters.
[0040] In some cases the multi-session humidification transition is defined by an elapsed time. In some cases an initial period and / or a final period of an operating session are not accumulated as the elapsed time. In some cases the initial period comprises a session acclimatisation period. In some cases the session acclimatisation period provides a warmup period to the initial operating parameter level. In some cases the final period comprises a session acclimatisation period. In some cases the session acclimatisation period provides a cool-down period from the desired session operation parameter. In some cases the session acclimatisation period provides a constant operating parameterlevel or an increasing operating parameter level or a decreasing operating parameter level.
[0041] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a controller configured to control the flow of gases based on one or more operating parameters, wherein the controller is configured to: obtain one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more operating parameters based on the one or more prior operating parameters, and set the one or more operating parameters of the respiratory apparatus. In some cases the operating parameters comprises any one or more of: humidification, temperature, gases concentration, pressure and flow rate. The optional features above relating to humidification, but amended for the alternative parameters may be applied to this disclosure. The optional features below relating to a method may also be applied to this disclosure.
[0042] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a controller configured to control the flow of gases based on one or more operating parameters, wherein the controller is configured to: obtain one or more desired operating parameters for delivering therapy to the patient; obtain one or more initial operating parameters for the patient; determine a parameter transition configured to increase the initial operating parameters to the desired operating parameters over a plurality of sessions. In some cases the operating parameters comprises any one or more of: humidification, temperature, gases concentration, pressure and flow rate. The optional features above relating to humidification, but amended for the alternative parameters may be applied to this disclosure. The optional features below relating to a method may also be applied to this disclosure.
[0043] In one aspect the present disclosure may be said to comprise a method for controlling a respiratory apparatus for high flow therapy, the method comprising the steps of: obtaining one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determining the one or more operatingparameters based on the one or more prior operating parameters, and setting, on the respiratory apparatus, the one or more operating parameters .
[0044] In some cases the one or more operating parameters and / or the one or more prior operating parameters comprise any one or more of: an operational set point, a desired operating level, a flow rate, pressure, humidity, gases concentration, or temperature, a maximum previously reached set point, and / or a time above a threshold parameter. In some cases the one or more prior operating parameters comprise a prior operating level. In some cases the one or more prior operating parameters comprises timing data from one or more previous operating sessions. Optionally timing data comprises a length of one or more previous operating sessions and / or a length of one or more parts or operating parameter settings of one or more previous operating sessions. In some cases the one or more operating parameters are the same parameters as the one or more prior operating parameters. In some cases the one or more operating parameters are configured to increase the operating parameter of the flow of gases over the therapy session.
[0045] In some cases the one or more operating parameters comprise a parameter transition. In some cases comprising the step of determining a parameter transition based on the one or more operating parameters. In some cases the parameter transition is between an initial parameter level and a desired parameter level. In some cases the initial parameter level is a comfort parameter level. In some cases the desired parameter level is a therapeutic parameter level. In some cases comprising the step of receiving the desired parameter level from a clinician. In some cases the initial parameter level and / or the desired parameter level are parameter set points of the respiratory apparatus. In some cases the initial parameter level and / or the desired parameter level are delivered operating parameters of the respiratory apparatus. In some cases the delivered operating parameter comprises a parameter of the flow of gases leaving the respiratory apparatus.
[0046] In some cases the initial parameter level is less than, or the same as, the desired parameter level of an immediately prior operating session and / or the maximum parameter of the immediately prior operating session. In some cases the initial parameter level is modified based on an adherence parameter of the immediately prior operatingsession. In some cases the initial parameter level is lowered if an adherence parameter shows poor adherence at the operating parameters of the prior operating session. In some cases comprising the step of determining the parameter transition from a modification of the one or more operating parameters from the one or more prior operating parameters to or towards one or more desired operating parameters. In some cases the modification of the one or more operating parameters comprises an increase in the one or more operating parameters. In some cases the increase comprises an increment. In some cases the increment is predefined. In some cases the increment is the same as a prior increment of the one or more prior operating parameters. In some cases the increment is modified from the prior increment of the one or more prior operating parameters. In some cases the time period of the increment is modified. In some cases the size of the increment is modified from the prior increment. In some cases the modification is dependent on an adherence parameter of the one or more prior operating sessions. In some cases the increment is configured to be set by a clinician.
[0047] In some cases the parameter transition comprises a fixed number of sessions and / or a variable number of sessions. In some cases comprising the step of determining the parameter transition over a plurality of operating sessions. In some cases the parameter transition is configured to increase the one or more operating parameters to one or more desired operating levels over a predefined number of sessions. In some cases the parameter transition comprises a plurality of session parameter transitions. In some cases each of the session parameter transitions comprise an increase from an initial session parameter level to a desired session parameter level. In some cases the initial session parameter level increases in each later session parameter transition. In some cases the desired session parameter level increases in each later session parameter transition. In some cases the initial session parameter level is less than the desired session parameter level of the immediately prior session parameter transition. In some cases at least one session parameter transition is repeated in two or more consecutive sessions.
[0048] In some cases a rate of the increase between the initial session parameter level and the desired session parameter level is constant. In some cases a rate of increase between the initial session parameter level and the desired session parameter levelreduces and / or increases over the session. In some cases the size increase between the initial session parameter level and the desired session parameter level is the same as in one or more, or all, of the prior sessions. In some cases a rate of increase between the initial session parameter level and the desired session parameter level is the same as in one or more, or all, of the prior sessions. In some cases the increase between the initial session parameter level and the desired session parameter level comprises one or more steps. In some cases each session parameter transition has a fixed time period. In some cases each session parameter transition has a variable time period. In some cases the time period comprises any one or more of: an operating session, less than an operating session, at least 30 minutes, at least 60 minutes, at least 90 minutes, at least 120 minutes, at least 150 minutes, or at least 180 minutes.
[0049] In some cases the time period is determined based on the one or more prior operating parameters. In some cases the time period is determined based on the length of one or more prior sessions. In some cases the time period is a minimum, maximum and / or average of the length of the one or more prior sessions. In some cases the session parameter transition comprises a a session parameter profile.
[0050] In some cases the step of receiving an input comprises receiving one or more input operating parameters. In some cases the one or more operating parameters comprise the one or more input operating parameters. In some cases the input is received over a communications channel. In some cases the communications channel is to a remote processor. In some cases the input is received from a user interface. In some cases the input operating parameters comprise a parameter transition. In some cases parameter transition comprises one or more initial operating parameters and one or more desired operating parameters. In some cases the parameter transition comprises one or more session parameter transition profiles.
[0051] In some cases the controller is configured to receive an input of one or more comfort parameters. In some cases the comfort parameter indicates a patient discomfort. In some cases comprising the step of changing one or more of the operating parameters based on the one or more comfort parameters. In some cases one or more of theoperating parameters are reduced. In some cases comprising the step of increasing the operating parameter over a time period after the reduction.
[0052] In some cases the increase in the operating parameter is to a desired operating parameter. In some cases the increase in the operating parameter is to a value below the desired operating parameter. In some cases the step of lowering a desired operating parameter on receiving the one or more comfort parameters. In some cases comprising the step of changing the rate of increase of the one or more operating parameters on receiving the one or more comfort parameters. In some cases the rate of increase is lowered. In some cases the change in the operating parameter is determined based on one or more of: the desired session parameter level, the initial session parameter level, and the parameter level when the comfort parameter was received.
[0053] In some cases the respiratory apparatus is configured to provide a pressure therapy mode. In some cases the controller is configured to apply a parameter therapy transition when moving between a pressure therapy mode and a high flow mode. In some cases the parameter therapy transition comprises an initial parameter level at or near the pressure therapy mode parameter level and a target parameter level at a high flow therapy parameter level. In some cases the controller is configured to determine, from the one or more prior operating parameters, any one or more of: a length of a prior session, a minimum, maximum, initial, final or average parameter set point or output of the prior session, and an event during a prior session.
[0054] In some cases the controller is configured to determine a time period from the beginning of the prior session until the event. In some cases the controller is configured to control the parameter based on the determined time period. In some cases the controller is configured to modify an operating parameter before the determined time period has elapsed in the current operating session. In some cases the controller is configured to reduce the one or more operating parameters before time period has elapsed in the current operating session. In some cases the controller is configured to adjust the time period of a session parameter transition based on the determined time period. In some cases the event is determined by one or more of: removal of a patient interface, unexpected ending of the prior operating session, patient inputs during theprior operating session, flow rate changes, operating parameter changes, and water levels.
[0055] In some cases the one or more operating parameters are also be based on one or more of: a (optionally humidifier) flow rate; a (optionally humidifier) water level; time of day; and therapy settings. In some cases the controller is configured to determine the time of day of the one or more prior sessions. In some cases the respiratory apparatus comprises a clock configured to determine the time of day. In some cases the controller is configured to determine if the prior session was an overnight session based on the time of day of the prior session. In some cases an overnight session is a session occurring between at least the hours of 12am and 1 am. In some cases the controller is configured to determine a session length based on the time period of the determined overnight session. In some cases the controller is configured to determine the one or more operating parameters based on the length of the determined overnight session.
[0056] In some cases the controller is configured to determine a water level of the respiratory apparatus. In some cases the controller is configured to determine the one or more operating parameters based on the determined water level. In some cases the water level comprising a water level in a water chamber of a humidifier of the respiratory apparatus. In some cases the controller is configured to determine the one or more operating parameters based on the determined water level and a predicted session length. In some cases the controller is configured to set the one or more operating parameters to provide a time period at a desired parameter level at the end of a therapy session. In some cases the time period is 15 minutes, 30 minutes, 45 minutes or 1 hour.
[0057] In some cases the controller is configured to determine an apparatus parameter. In some cases the apparatus parameter is detected by a sensor. In some cases the sensor comprises one or more of a flow sensor or pressure sensor. In some cases the apparatus parameter is indicative of an operation of the apparatus and / or a patient action. In some cases the parameter is indicative of any one or more of: a patient adherence to the apparatus; a patient ceasing therapy; and a patient removing a patient interface. In some cases the controller is configured to prompt the patient to identify the reason forremoving the patient interface. In some cases the controller is configured to record one or more operating parameters when the user interface is removed.
[0058] In some cases the controller is configured to record the one or more operating parameters set by the respiratory apparatus. In some cases the recorded one or more operating parameters are configured to be available to a future apparatus session. In some cases the one or more operating parameters comprise environmental parameters. In some cases the operating parameter comprises an ambient temperature and / or humidity. In some cases the controller is configured to control the flow rate of the flow of gases based on the one or more operating parameters. In some cases the controller is configured to control a flow rate of the flow of gases. In some cases the flow rate is controlled by one or more of a valve and / or a blower.
[0059] In some cases the controller is configured to store the one or more operating parameters. In some cases the prior operating session comprises a time period between switching on the respiratory apparatus and switching off the respiratory apparatus. In some cases the prior operating session comprises aggregated use of the respiratory apparatus over a time. In some cases the time period is 24 hours or 12 hours. In some cases the prior operating session comprises a therapeutic session. In some cases the therapeutic session comprises a minimum time period defined by a clinician. In some cases the therapeutic session comprises a minimum time period of: at least 2 hours, at least 3 hours, at least 4 hours, at least 6 hours, at least 8 hours, at least 10 hours, and overnight.
[0060] In one aspect the present disclosure may be said to comprise a method for controlling a respiratory apparatus for high flow therapy, the method comprising the steps of: obtaining one or more desired operating parameters for delivering therapy to the patient; obtaining one or more initial operating parameters for the patient; determining a parameter transition configured to increase the initial operating parameters to the desired operating parameters over a plurality of sessions.
[0061] In some cases the parameter transition comprises a plurality of session parameter transitions. The optional features above relating to humidification, but amended for theoperating parameters, may be applied to this disclosure. The optional features relating to methods may also be applied to this disclosure.
[0062] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a controller configured to control the flow of gases based on one or more operating parameters, wherein the controller is configured to: obtain one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more operating parameters based on the one or more prior operating parameters, and set the one or more operating parameters of the respiratory apparatus. The optional features above relating to humidification, but amended for the operating parameters, may be applied to this disclosure. The optional features relating to methods may also be applied to this disclosure.
[0063] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more humidification parameters, and a controller configured to control the humidifier by adjusting a humidity set point of the humidifier, wherein the controller is configured to increase the humidity set point of the humidifier over a plurality of therapy sessions, to increase the humidity of the delivered flow of gases over the plurality of sessions. The optional features above relating to humidification may be applied to this disclosure. The optional features relating to methods may also be applied to this disclosure.
[0064] In one aspect the present disclosure may be said to comprise a method for controlling a high flow therapy apparatus configured to deliver a flow of gases, the method comprising the steps of: controlling the humidifier by adjusting a humidity set point of the humidifier, increasing the humidity set point of the humidifier over a plurality of therapy sessions, to increase the humidity of the delivered flow of gases over the plurality of sessions. The optional features above relating to humidification, but amended for the operating parameters, may be applied to this disclosure. The optional features relating to methods may also be applied to this disclosure.
[0065] In one aspect the present disclosure may be said to comprise a system for controlling a respiratory apparatus, the system comprising: a controller configured to control one or more operating parameters of the respiratory apparatus; and a server in communication with the controller, wherein the server: receives one or more operating parameters for use of the respiratory apparatus with a patient; determines a parameter transition for the patient over a plurality of sessions; and transmits the parameter transition to the controller. In some cases the system transmits the parameter transition as session humidification transitions. The optional features above relating to humidification, but amended for the operating parameters, may be applied to this disclosure. The optional features relating to methods may also be applied to this disclosure.
[0066] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a controller configured to control the flow of gases based on one or more operating parameters, wherein the controller is configured to: obtain an elapsed time of operation of the respiratory apparatus, determine the one or more operating parameters based on the one or more elapsed time of operation of the respiratory apparatus and a multi-session operational parameter transition, and set the one or more operating parameters of the respiratory apparatus.
[0067] In some cases the elapsed time of operation is a therapeutic time of operation. In some cases the therapeutic time of operation omits one or more of an initial period of operation (warm-up), a final period of operation (warm-down) and / or one or more periods of time in which the patient is not receiving therapy. The optional features relating to methods and apparatus described above may also be applied to this disclosure.
[0068] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the humidifier, wherein the controller is configured to: determine an initial operating parameter for anoperating session, determine a desired operating parameter for an operating session, determine an operating parameter transition to move from the initial operating parameter to the desired operating parameter over the operating session, apply the operating parameter transition and determine if a patient is receiving the flow of gases, wherein the operating parameter transition is paused if the patient is determined not to be receiving the flow of gases.
[0069] In one aspect the present disclosure may be said to comprise a respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the humidifier, wherein the controller is configured to: determine an initial operating parameter for an operating session, determine a desired operating parameter for an operating session, determine an operating parameter transition to move from the initial operating parameter to the desired operating parameter over the operating session, wherein the controller is configured to begin the operating parameter transition once it determines that a patient is receiving, or ready to receive, the flow of gases. In some cases the initial operating parameter is maintained until the patient is receiving, or ready to receive, the flow of gases.
[0070] In some cases determining if the patient is receiving the flow of gases comprises determining if the patient is wearing the patient interface. In some cases wearing of the patient interface is determined by a sensor associated with the patient interface and / or a sensor associated with the flow of gases. In some cases the controller is configured to modify the operating parameter transition based on a determination that the patient has removed the patient interface. In some cases the operating parameter transition is a session operating parameter transition. The term "non-sealing patient interface" (i.e., unsealed patient interface) as used herein can refer to an interface providing a pneumatic link between an airway of a patient and a gases flow source (such as from flow generator 1 1) that does not completely occlude the airway of the patient. A non-sealed pneumatic link can comprise an occlusion of less than about 95% of the airway of the patient. The non-sealed pneumatic link can comprise an occlusion of less than about 90% of theairway of the patient. The non-sealed pneumatic link can comprise an occlusion of between about 40% and about 80% of the airway of the patient. The airway can include one or both nares of the patient and / or their mouth. For a nasal cannula the airway is through the nares. In some configurations, the "non-sealing patient interface" may comprise a tracheal interface.
[0071] The term "comprising" as used in this specification means "consisting at least in part of". When interpreting each statement in this specification that includes the term "comprising", features other than that orthose prefaced by the term may also be present. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.
[0072] It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 1 , 1.1 , 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1 .5 to 5.5 and 3.1 to 4.7)BRIEF DESCRIPTION OF DRAWINGS
[0073] Examples will be described with reference to the following drawings, of which:
[0074] Figure 1 is a block diagram of a respiratory apparatus that can implement the present examples.
[0075] Figure 2 is a block diagram of an alternative respiratory apparatus that can implement the present examples.
[0076] Figure 3 is a diagram showing multiple sessions.
[0077] Figure 4 is a diagram showing a humidification transition over multiple sessions, with session humidification transitions shown.
[0078] Figure 5 is a diagram showing a humidification transition over multiple sessions.
[0079] Figure 6 is a diagram showing an example session humidification transition.
[0080] Figure 7 is a diagram showing an example session humidification transition.
[0081] Figure 8 is a diagram showing an example session humidification transition.
[0082] Figure 9 is a diagram showing an example session humidification transition.
[0083] Figure 10 is a diagram showing an example session humidification transition.
[0084] Figure 1 1 is a diagram showing an example session humidification transition.
[0085] Figure 12 is a diagram showing an example session humidification transition.
[0086] Figure 13 is an example flow chart of the apparatus humidification parameters being set.
[0087] Figure 14 is an example flow chart of the apparatus humidification parameters being set.
[0088] Figure 15 is an example flow chart of the apparatus humidification parameters being modified.
[0089] Figure 16 is an example of the communications between the apparatus, a server and a personal electronic device.
[0090] Figure 17 is an example flow chart of a multi-session operating parameter transition being applied.
[0091] Figure 18 is a diagram showing a humidification transition over multiple sessions based on elapsed time.
[0092] Figure 19 is a diagram showing dual humidification transitions over multiple sessions of different therapies.
[0093] Figure 20 is a diagram showing dual humidification transitions over multiple sessions of different therapies.
[0094] Figure 21 is a diagram showing dual humidification transitions over multiple types of sessions.
[0095] Figure 22 is a diagram showing responses of a session humidity transition to user indications of discomfort.DETAILED DESCRIPTION
[0096] It should be noted that the present specification refers to humidity. There are various parameters that can directly or indirectly indicate humidity, such as relative humidity, absolute humidity and dew point. These can be interchangeably converted using relevant conversion parameters and / or knowledge of environmental factors, such as temperature and pressure. For example, dew point can be converted to a relative humidity if the relevant air pressure and temperature are known. As such, any reference to humidity refers to the concept itself and is not necessarily restricted any particular parameter type that can define or indicate humidity.
[0097] Reference to one type of humidification parameter (e.g. dew point) in an example is not limiting, and the same concept described can be applied using other humidification parameters. Where the description relates to the control of humidity it should not be limited to the particular parameter used as indicative of humidity, although there may be advantages to using particular parameters. While each such humidification parameter might be convertible, they are not necessarily directly interchangeable and are different parameters that have their own technical uses. For example, in some circumstances a particular parameter, such as any one or more of dew point, relative humidity and absolute humidity, may be easier to calculate or more suited to a particular method than an alternative parameter of humidity. A parameter that can be used to refer to humidity might not actually be a direct measure of humidity and / or might be a different parameter to other parameters that are indicative of humidity.
[0098] In general, humidification parameters are adjusted to control, or be indicative of, the amount of humidity the respiratory apparatus is providing to the patient or is configured to provide to or at or near the patient interface. Humidification parameters may be used to implement a humidification level. There are a variety of ways to identify this humidification level. In a humidifier the humidification level may be expressed as an amount of humidity that the humidifier is adding to the flow of gases. In some cases the humidification level is expressed as the humidity in the flow of gases leaving the humidifier, or at the outlet of the humidifier or as received by the patient at the patient interface (i.e. a delivered humidity). The location of sensors and / or controllers in the humidifier and / or respiratory apparatus may lead to a preferred selection of a humidification parameter. The humidification level is typically controlled by controlling the humidity the humidifier is adding to the flow of gases through the humidifier. For example, the temperature, or time of operation, of a heater plate can vary the humidity added by the respiratory apparatus. Although several humidification parameters are specifically described herein the skilled person will understand alternative humidification parameters may be used where they provide an indication of the humidity in the flow of gases.
[0099] Respiratory apparatus (also termed interchangeably: "respiratory therapy apparatus", "respiratory support apparatus", "breathing assistance apparatus", "respiratory therapy device", "respiratory humidification system") can provide breathing gas to a patient with controlled flow and / or pressure to support respiratory function. This could be in a hospital or home environment. Typically respiratory apparatus / respiratory function support might comprise (without limitation): High flow therapy (also called nasal high flow, HFT or NHF, e.g. for patients suffering from a lung disease e.g. dyspnea, respiratory distress, pneumonia, emphysema and other obstructive pulmonary diseases), BiLevel / NIV pressure support (including various sub modes e.g. S / T mode, T mode etc.), CPAP support (for OSA), humidifier respiratory therapy, or the like. Such respiratory apparatus can have humidifiers that control humidity of the breathing gas provided to a patient. They can also control the temperature of the breathing gas provided to the patient. Humidity and / or temperature is provided to improve patient experience and health outcomes for the patient. As a non-limiting example, flow therapy uses a respiratory apparatus 1 to provide a gas flow to a patient with a flow rate (e.g. above 15 L / min), temperature (e.g. 37degree Celsius (C)) and a humidity (e.g. a 37 degree C dew point or 44mg of absolute humidity). Respiratory apparatuses may have specific features or configurations to enable high flow therapy. In some cases these apparatuses are also configured to provide further therapies, such as CPAP or Bi-level therapy.
[0100] High flow therapy, as discussed herein, is intended to be given its typical ordinary meaning as understood by a person of skill in the art which generally refers to a respiratory apparatus delivering a targeted flow of humidified respiratory gases via an intentionally unsealed patient interface with flow rates generally intended to meet or exceed inspiratory flow of a patient. Typical patient interfaces include, but are not limited to, a nasal or tracheal patient interface. Typical flow rates for adults often range from, but are not limited to, about fifteen litres per minute to about sixty litres per minute, or greater. Typical flow rates for paediatric patients (such as neonates, infants and children) often range from, but are not limited to, about one litre per minute per kilogram of patient weight to about three litres per minute per kilogram of patient weight or greater. High flow therapy can also optionally include gas mixture compositions includingsupplemental oxygen and / or administration of therapeutic medicaments. High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or tracheal high flow (THF), among other common names.
[0101] For example, in some configurations, for an adult patient 'high flow therapy' may refer to the delivery of gases to a patient at a flow rate of greater than or equal to about 10 litres per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or child patient, 'high flow therapy' may refer to the delivery of gases to a patient at a flow rate of greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. A high flow therapy apparatus with an adult patient, a neonatal, infant, or child patient, may, in some configurations, deliver gases to the patient at a flow rate of between about 1 LPM and about 100 LPM, or at a flow rate in any of the sub-ranges outlined above.
[0102] Gases delivered may comprise a percentage of oxygen. In some configurations, the percentage of oxygen in the gases delivered may 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%. High flow therapy may be administered to the nares of a patient and / or orally, or via a tracheostomy interface.
[0103] High flow therapy may be used to treat patients with obstructive pulmonary conditions e.g., COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema and / or patients with respiratory distress or hypercapnic patients. Humidified high flow therapy increases mucociliary movement in the patient's respiratory tracts. For example, evidence has shown high flow therapy provided with a humidity of 37 degrees dewpoint 100% relative humidity improves mucus clearance and reduces exacerbations for COPD patients. The humidity in combination with a consistent high flow rate, are required to achieve the benefits.
[0104] When a healthy person breathes, their nasal passage humidifies inhaled ambient air before it enters their respiratory system. During high flow therapy, at the flow rates needed to achieve mucociliary movement and dead space clearance, the flow overwhelms the capacity of a patient's nasal passage to humidify the air sufficiently before it passes through. If the air is not humidified before entering the airways it causes the nostrils and upper airway to dry-out which is deeply uncomfortable to the person receiving therapy, and if left for an extended period could cause damage to their respiratory system. This issue is heightened when a supplemental oxygen source (e.g., an 02 canister) is connected to the high flow device as pure oxygen gas is dry. Humidity is needed in HFT to promote mucociliary movement, increase patient comfort, and lead to greater compliance. It is a requirement of HFT that air must be humidified prior to entering the nares.
[0105] Home patients may have lower levels of care required and be less tolerant of high humidity levels. At home there is less supervision by clinicians of use or adherence to therapies. Usage at home may be for several hours a day for extended periods of time. Lack of compliance in home environments occurs. The present disclosure provides an approach to help patients acclimatise to the therapy and be more compliant by addressing issues due to patient discomfort from high humidity therapy.
[0106] When operating, the respiratory apparatus has operating parameters, which can comprise gas flow parameters such as gas flow humidity, temperature, oxygen fraction, pressure and / or flow rate (among others). When providing therapy, the respiratory apparatus has operating parameters that will be at an operational level (thatis, a parameter value)- these being parameter levels that provide therapy. Typical parameters values (by way of non-limiting example) are: 37 degrees C dewpoint at 100%RH (relative humidity). Other humidification settings, such as dewpoint settings could be any one or more of 31 , 34, and 37 degrees C. Where dewpoints are discussed herein they are expressed in degrees Celsius.
[0107] When a respiratory apparatus is being used but is not providing therapy at the operational or prescribed level, the operating parameters might be at a non-operational level. Typically, an operating parameter could be described as a therapy parameter, and an operational level could be a specified level, user set level, therapy level or similar depending on the purpose of the operating parameter and / or how it is specified. These might be different or the same levels depending on operational context. Examples are:
[0108] Specified level - a specified parameter value specified by a clinician. Typically the specified level will be an operational level, such as a therapy level / prescribed level of the parameter suitable for treating the patient.
[0109] User set level - a parameter value set by a user. Typically the user set level will be an operational level, such as a therapy level / prescribed level of the parameter suitable for treating the patient. But it might be some other level and / or it might be specified by the user.
[0110] Therapy level - a parameter value (e.g. 37 degrees C with dewpoint at 100%RH. Other dewpoint settings could be 31 degrees Celsius, 34 degrees Celsius) of an operating parameter set to a therapeutic level to provide therapy (such as CPAP, NHF, Bilevel, humidification support) to a patient. It might also be a prescribed level. That is to say the therapy level may be a level set or issued by a clinician that a patient is suggested to use. Therapy level may comprise at least a humidity level and a flow rate.
[0111] Prescribed level - a parameter value of an operating parameter set to a level prescribed by a clinician. It might also be a therapy level.
[0112] In general terms, an operational level of an operating parameter is a value provided during operation to provide therapy, irrespective of what it is specified by, or the method or person by which it is set. At other times, an operating parameter might be at a non-operational level that does not provide therapy or does not provide the setor prescribed therapy level. That might include an initial comfort level, as described later that may be used to acclimatise a patient to the operational level.
[0113] Many respiratory conditions, such as bronchiectasis or COPD diseases, can cause mucus to accumulate in the respiratory tract. In a healthy human, the amount of mucus produced is small enough that it is cleared before it can settle. However, in a patient with COPD, the quantity of mucus produced can be above the capacity of the body to clear it, causing it to remain lining the respiratory tract, capturing particles from passing air. The longer the excess mucus is sedentary, the more likely it is that infection will be introduced from the passing air. Compliance to therapy is therefore an important requirement to achieve therapeutic outcomes, particularly for patients using flow therapy at home. Using therapy e.g. high flow therapy for a prescribed time is useful to achieve therapeutic outcomes. A home-based patient should use the respiratory apparatus in a prescribed manner (e.g. for a prescribed time per day e.g. at least 4 hours a day, at a prescribed flow rate, humidity, temperature and / or another prescribed parameter). A prescription (e.g., a prescribed level of therapy) is provided by a patient's doctor, clinician or the like. Alternatively, patients are encouraged to use the respiratory apparatus when they are feeling breathless or feeling respiratory distress to provide relief to the patient. The patient may use the respiratory apparatus for as long as needed. Generally the longer a patient uses the respiratory apparatus, the better the outcomes for the patient.
[0114] However, with a flow of heated, humidified gases some patients can experience discomfort, due to temperature and / or humidity of the breathing gas at the operational level. For example, patients complain of hot / wet or hot / sticky feeling around nose and lips when receiving humidified and heated air. This discomfort can reduce patient compliance with the therapy- e.g. a patient might not use the respiratory apparatus 10 from the prescribed time. This problem is particularly an issue in the home environment as there are no clinicians to provide support. Clinicians want their patients to comply to therapy. Often patients treated at home suffer from a chronic condition e.g. COPD and sufferers are often treated with NHF therapy or BiLevel therapy. Sleep Apnea sufferers are treated with CPAP and compliance is important for this patient group too. That said, compliance is also important for hospital patients, who generally are moreacute and suffer from acute respiratory conditions or they may have had an exacerbation. Again, compliance and use of the therapy for acute respiratory patients is also very important.
[0115] Patients with COPD can be prescribed a high flow therapy (HFT) device to help manage and alleviate their symptoms. Clinicians generally provide the patient with device settings (operating parameters) to use, a desired session length, and session frequency. The settings may include flow rate, temperature and humidification level (dew point). Unfortunately, many patients do not consistently adhere to the clinician settings to meet their compliance requirements. In some cases a patient having issues or experiencing discomfort with a therapy regime can be identified through their behaviour while receiving therapy. When the humidification level is uncomfortable, a patient may remove the interface or end the therapy session prematurely before the prescribed time has elapsed. Other patients may complete their prescribed therapy times, albeit at reduced humidity and / or flow settings. This leads to diminished health outcomes from less- effective therapy. Encouraging patients to follow the prescribed settings attains the best health outcomes. For some patients the transition to high flow can be difficult, for others, using their settings for the prescribed period is uncomfortable.
[0116] For example, humidity is an operating parameter for high flow therapy. Humidified high flow therapy increases mucociliary movement in the patient's respiratory tracts. For example, high flow therapy provided with a humidity of 37 degrees dewpoint 100% relative humidity has been demonstrated to improve mucus clearance and / or reduce exacerbations for COPD patients. High flow therapy (HFT) provides increased humidity in combination with a consistent high flow rate. The high flow rate is provided to flush out CO2 residing in upper airway dead spaces. If the air is not humidified before entering the airways it causes the nostrils and upper airway to dry-out which is deeply uncomfortable to the person receiving therapy, and if left for an extended period could cause damage to their respiratory system. This issue is heightened when a supplemental oxygen source (e.g., an 02 canister) is connected to the high flow device as pure oxygen gas is dry. Humidity is needed in high flow therapy to promote mucociliary movement, increase patient comfort, and lead to greater compliance. Therefore, air is humidifiedprior to entering the nares. A desired humidification level may be 37-degree C dew point, or 44mg / L of humidity. However, the humidified air provided at a high flow rate is not always comfortable for the patient. In particular the applicants have found that the humidification level may cause apparent discomfort to the patient even when at therapeutic operating levels to improve, for example, mucociliary movement. This may cause the patient to cease treatment before the benefit of the high level of humidity is realised. Other parameters may also alter a patient's comfort.
[0117] The described systems and / or methods provide comfort to a user. Comfort includes acclimatisation to a new therapy level or simply comfort when using the apparatus. A change in therapy, or health status, may require further user comfort. A comfort level may be discussed. The comfort level refers to a parameter level at which the user is, or appears, comfortable. This may be ascertained by asking the user (such as through feedback on the device) or by determining adherence to the therapy (such as by monitoring patient interface removal). In some cases, a comfort level may be assumed, for example based on data on typical comfort levels. The disclosure shows methods to increase the comfort level over time to increase benefit of the therapy by having increased humidity. The comfort level may be implemented as an initial parameter level, reflecting that the comfort level may form a baseline to which the system begins at and / or returns to if patient discomfort is identified. For example, a humidification level where the patient can tolerate the humidity of the gas flow in a manner that they will more likely use the respiratory apparatus. The apparatus may determine a comfort level, or it may be provided externally.
[0118] In some cases an intra-session humidification transition (or comfort system or mode) is provided. An intra-session comfort system adjusts humidity within a session to improve comfort, such as acclimatisation. For example, during a therapy session the patient may enable a "comfort mode" wherein one or more of the operating parameters, such as humidification, flow or temperature, reduces from an operational level (normally prescribed by a clinician) to a lower humidity (which may be a comfort humidity), then is gradually ramped back to the operational humidity over a period. An intra-session comfort mode provides temporary relief to the patient within a therapy session. This maybe beneficial to enable the patient to continue receiving therapy when they otherwise would have stopped. However, intra-session therapy may not improve the patient's tolerance to the operating parameter level. In some cases the period at the comfort parameter level allows them to "cool-off" or reset their capacity to endure the operational level instead of improving comfort at the operational level. The intra-session humidity transition may be applied when the apparatus is operating, and the patient is wearing the patient interface. If the patient interface is removed, or the apparatus is not operational, the humidity transition may be paused until the patient replaces the patient interface or restarts therapy.
[0119] The present disclosure relates to improving patient comfort when using a respiratory apparatus, which in turn results in improved compliance with respiratory apparatus use / therapy. The present disclosure identifies that assisting a patient to gain comfort with (that is, get used to / tolerate) the operating parameters, such as humidification, flow or temperature, over multiple sessions can improve patient experience (comfort) and therefore compliance. This may be used to acclimatise patients to the treatment. However, patients don't often have any medical staff (e.g. nurses) or other technical staff that can adjust the humidification level.
[0120] The present examples provide a respiratory apparatus for providing a gas flow with operating parameters. For example, a flow rate, pressure, oxygen fraction, temperature and humidity (gas flow (operating) parameters), where the gas flow parameters can be controlled to assist the patient acclimatise to the prescribed humidification and / or temperature and / or flow and / or oxygen level over multiple sessions, resulting in assisting the patient to achieve compliance.
[0121] The described examples provide a parameter (such as humidification) transition between an initial (comfort) parameter level and the prescribed or desired parameter level. The transition, such as a ramp, may be configured to be implemented over the course of multiple sessions. A multi-session humidification transition may allow a patient to be gradually transitioned from the comfort humidification level to a desired humidification level (e.g., a higher therapeutic level) over multiple therapy sessions. This may be achieved by controlling one or more humidification parameters which set thehumidification level. This process may be beneficial because incremental increases over multiple sessions are less noticeable to the patient and / or the multiple sessions allow the increases to be gradual enough that the patient can acclimatize to the change in one session before the next session.
[0122] The transitions may be implemented in a number of forms. For example, there may be change in the parameter between sessions, such as an increment. In each session the parameter may remain substantially constant. This would increase the parameter over the multiple sessions, while providing constant therapy within a session. Alternatively, in each session the parameter may be varied. This could encourage an increase in comfort level, such as the described intra-session comfort system. Alternatively, a transition may be divided over multiple sessions. For example, each session may start at, or near, the final parameter level of the session before. This can provide a more gradual increase without large steps. In some cases a combination of methods may be used.
[0123] A humidity transition applied over multiple sessions is termed a multi-session transition. In some cases, a multi-session transition is specified by a plurality of sessions, each session having a predefined humidity transition. In some cases, the operation in each session is dependent on the previous session. For example, the humidification level may increase by an increment over the previous session. In some cases, each session of the multi-session transition is determined based on the multi-session transition profile and the number of sessions. In some cases, the multi-session transition may be specified by a predefined time-period. For example, the operation in each session depending on the length of time the humidity transition has been operating for (elapsed time) across all of the preceding sessions. In some cases, an initial and / or final phase of each session may be applied before the humidity transition begins. The choice of how to apply a multisession humidity transition may depend on, for example, the client or therapeutic need. Optionally, the outcome, or performance, of the prior session may be accounted for.
[0124] In some cases a clinician can instruct, or remotely instruct, a multi-session humidification transition. In some cases a patient could configure a multi-session humidification transition on a computing device or on the user interface of the therapy apparatus. In some cases, a server-based / remote computer could determine fromtherapy events (e.g. interface removals), device usage data (run time), therapy data (settings used) and other device sensors (light, sound) that a multi-session humidification transition may be beneficial to increase the patient's therapy habits. In some cases the respiratory apparatus is configured to implement a multi-session humidification transition based on initial and desired humidification levels.
[0125] In some cases the patient can select between multiple therapy levels that correspond to different control options for humidification transitions. For example, a low, medium, or high humidity options could be selected by the patient. The selection could alter the rate of change of the humidification level, or lower / raise the humidity provided, but with the same change rate. This could provide a simple input forthe patient to control the humidification transition.
[0126] In some cases, , the humidification transition in each session of a multi-session transition can be modified based on the patient's prior sessions. When a multi-session transition has been implemented, the humidification transition could be modified based, at least in part on user inputs, adherence events or humidification features. For example, the number of sessions or therapy minutes (i.e. time of therapy being received) to reach the operational level could be increased.
[0127] The multi-session humidification transition may be defined over a number of sessions, or a number of days. In some cases the humidification transition from an initial humidification level to the operational level of humidity is implemented over the course of multiple sessions and / or over multiple days. In some cases the humidification level, or an intra-session humidification transition, may be constant or the same for different sessions on the same day but change between days. Other time periods (hours / minutes / weeks) may be used instead of days.
[0128] Acclimatisation of the patient in a multi-session transition means the gas flow humidification parameters are changed over multiple sessions so that the patient does not experience discomfort that might otherwise be experienced if the operational humidification level of the operational humidification parameter(s) are higher than the patient is acclimatised to. Rather, due to the herein method, the patient experiences comfort in each session while the humidification parameter(s) are brought up tooperational level(s). By comfort, it is meant that as the humidification parameters are changed over time, the humidification levels are tolerable by the patient. This may comprise operating at a humidification level for a time period until the patient becomes used to that level and then the level is changed further until the operational humidification level is achieved. The time over which parameters are changed is long enough to allow the patient to get used to the parameters or parameter change. This leads to better compliance outcomes because the patient is comfortable / the provision of gas flow is at a tolerable humidity. A comfort mode (e.g. operation at least in part at a comfort level of humidification) might be configured to operate, for example, as soon as operational humidification level (s) of the operational humidity parameter(s) are provided, or after they have been provided for some time. For example, a patient may show discomfort at the operational humidification levels.
[0129] The comfort mode could also be provided proactively before operational humidification levels are provided, in anticipation that the patient might experience discomfort. It could be triggered at other times too. For example, the apparatus may monitor patient feedback or adherence data. If the patient is not adhering to the prescribed therapy the apparatus may initiate a multi-session humidification transition (e.g., a ramp) to improve patient comfort. The comfort mode may be activated based on the number of triggers of a comfort mode within a session, or other user inputs. The comfort mode may be triggered based on the number of interface removals within a session. This data may be recorded and / or sent to a server for tracking over multiple sessions. The comfort mode may, more generally be referred to as a type of multi-session humidification ramp.
[0130] As one non-limiting example, an initial level is some humidification level (and / or correspondingly a temperature and / or flow rate and / or supplemental oxygen and / or pressure level and / or other operating parameter) where the patient experiences less discomfort with the gas flow, possibly because of it being heated and / or humidified. In some cases the initial level is a comfort level. Typically the initial humidification level is lower than the operational (or therapeutic) humidification level. The initial level may not be the only level of an operating parameter that is tolerable to a patient but is the onethat is selected or predefined as a starting point. The humidity (or other parameter), is increased over multiple sessions of use of the apparatus to reach the operational humidification level. In some cases, the humidity (or other parameter(s)), might first also be maintained at the initial level for an initial period (which can form part of the time period or be separate to it) before being increased. This may reduce a discomfort due to change in parameter at the start of a session.
[0131] A session, or a therapy session, may be measured by the time between the respiratory apparatus being turned on and turned off. In some cases a therapy session is measured by a time period in which the respiratory apparatus is used. In some cases this comprises the respiratory apparatus being turned on and a patient received therapy. In some cases a patient is determined to be receiving therapy when a patient interface is worn. In some cases a patient is determined to be receiving therapy when a patient interface is worn and the respiratory apparatus is operating. In some cases a patient is determined to be receiving therapy based, at least in part, on a patient input. In some cases a patient is determined to be receiving therapy based, at least in part, on a presence detection.
[0132] In some cases a session, or therapy session is measured by the time in which an intra-session transition is applied. This may exclude an initial and / or final period of the use of the respiratory apparatus where a patient is wearing a patient interface but is receiving a non-transition humidification level. For example, an initial period may provide a warm-up profile to the initial humidification level. For example, a final period may provide a cool-down profile from the desired humidification. In some cases the initial and / or final period may form part (or be specified as part of) the session humidification transition or multi-session humidification transition. In this case the session or therapy session is measured from the start of the initial period and / or to the end of the final period. For example each session may have a 5- or 10-minute initial period before the humidity transition begins, or after the transition is complete. This may provide additional comfort.
[0133] In some cases the controller applies a final period to ensure a set period of constant humidification level is provided at the end of a session humidity transition. Thismay be part of the session humidification transition, or as a separate final period discussed above. This may be at the desired humidification level of the session. The time period may be at least 15 minutes, at least 30 minutes, at least 45 minutes, or at least an hour. By providing a constant humidification level at the end of the session the respiratory apparatus can accustom the patient to that level of therapy so as to allow it to be a comfort level for the next session.
[0134] In some cases, the respiratory apparatus has a non-therapeutic mode. For example a non-therapeutic mode is a warm-up mode. In a warm-up mode the humidifier warms up to the initial session humidification level. While in the warm-up mode the humidification level may be lower that the initial session humidification level. When the respiratory apparatus exits the non-therapeutic mode (for example, once the warm-up mode is completed), the patient may be prompted to put on their patient interface. In some cases any session, or humidification transition, does not begin until the respiratory apparatus has left the non-therapeutic mode and the patient is detected to be wearing the patient interface. In some cases a patient does not immediately put on the interface. The humidification apparatus may alert the patient that the session can begin. The apparatus may maintain the initial session humidification level, or other comfort level, until the patient is wearing their interface. In some cases a non-therapeutic mode is a cool-down mode, or a non-therapeutic mode may be used between types of sessions or types of therapy. In some cases a non-therapeutic mode is entered due to a lack of resources, such as water.
[0135] In some cases a minimum time may be required to be considered a session. The time may be at least 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, or overnight. In some cases the minimum time ensures the session is long enough to provide a helpful humidification transition. In some cases the session is considered to be a time period. For example the session may comprise one or more uses in a 12 hour or 24 hour period. The period may be a day, or between set hours. The use of a fixed time period allows the controller to consider the amount of use for a patient within a fixed period and how the patient may have acclimatised to that use. A session may be defined by a clinician as part of a prescription or therapy. In some casesthe humidification transition may be independent to the individual sessions. For example, the humidification transition may be defined by a time of operation of the respiratory apparatus or time of use where the patient is receiving therapy from the respiratory apparatus, In these cases each session humidification level is dependent on the elapsed time of operation or time of use.
[0136] In some cases, one or more sensors are used to detect the patient interface and / or the patient presence. For example, a pressure sensor on the patient interface may detect the interface is being worn. For example, the pressure and / or flow (or other operational settings) may allow the controller to determine if the patient interface is worn. Other methods of determining patients wearing a patient interface and / or receiving therapy may be used. WO2020178746A1 , incorporated herein by reference in full, provides examples of detecting if a patient is wearing a nasal cannula. The controller may stop any transition while the patient is not wearing the patient interface. The transition may be restarted when the patient is detected to be wearing the patient interface.
[0137] For example, a session humidification transition may not begin until detection of the patient wearing the patient interface and the operation of the humidification apparatus (either in therapeutic operation or warm-up mode). This ensures that the patient receives the full humidification transition during the session instead of missing a portion by having the apparatus on without the patient receiving therapy. In some cases the patient may use an interface to confirm the start of the transition. The apparatus may alert the patient to start the transition. In some cases the transition may pause if the patient interface is detected as not worn. This ensures that the patient receives the whole transition.
[0138] In some cases the number of sessions in the multi-session transition may be changed based on the length of sessions. This may adjust for short or long sessions. In one example a first session is stopped before the desired session humidification is reached. This may be due to the user stopping the respiratory apparatus prior to the session transition completing due to discomfort and / or due to time constraints. The controller may determine an action based on this session. For example, the controllermay respond by the next session repeating the first session humidification transition, or by adjusting the next session to have an initial humidification level at the humidification level reached in the first session or make no adjustment and move to the next session humidification transition. The first two options impact the length of the multi-session humidity transition because at least an additional session is required to account for the difference in humidification level. In some cases the controller may increase the humidification level more quickly in later sessions to account for the reduction.
[0139] As the humidity, or other parameter(s), of the gas flow increases from the initial level to the operational level over the multiple sessions, the patient can become comfortable with the increasing humidity, or other parameter(s), such that they can tolerate the operational level once it is reached. This is because the patient is are exposed to different levels of the operating parameters and can acclimatise to each level. The number of sessions is long enough / the rate of increase of humidity is slow enough, to allow the patient to get used to the humidity. This means the patient is more likely to use the respiratory apparatus at the operational level, being the prescribed level, and therefore more likely to achieve compliance.
[0140] In some cases each session of a multi-session humidification transition has a defined humidification transition. Defining a session humidification transition may provide comfort in each session, while providing a piecewise portion of the multi-session humidification transition. A session humidification transition may reduce the change between sessions, smoothing the feeling to the patient and, therefore, improving patient compliance. Patient compliance may be improved both within sessions and across a plurality of sessions. Comfort (e.g. the humidification transition) within sessions can be performed at any suitable time, such as after the respiratory apparatus has "warmed up", during the 'warm up' phase (initial orfinal periods of the session), or at or nearthe middle or end of a session. For example, priorto an increment or increase in humidification level, the humidity might first also be maintained at the initial humidification level for an initial portion of the session. This may be referred to as a maintenance period.
[0141] In some cases raising the humidity (or other parameter) over a time period may include maintaining the initial level (e.g., a comfort level) for a maintenance period as a part of the overall time period in which the parameters increase.
[0142] In some cases a gradual increase is applied in each session. This gradual increase (that is "ramp" or "ramp rate" or rate of increase) of humidity helps acclimatise the patient to the humidification parameters. A ramp rate could be defined as change in parameter over time, such as change in humidity over time (e.g. change in %RH per minute, or dew point over time) or change in temperature over time (e.g. change in degrees C per minute). In one example the ramp rate occurs at the start of a session. A constant humidification level may be provided for the remaining session time. However, as will be described, acclimatisation can be provided at other times. The time period / ramp rate is intended to be long enough / the ramp is slow enough to allow the patient to get used to the humidity and / or temperature. The ramp rate could be linear (constant ramp) or non-linear over time. The ramp rate may be stepped. The ramp rate may be linear after the initial period if there is such a period.
[0143] In some cases the controller operates a session at a constant humidification level, this is incremented from the humidification level of the previous session. In some cases a ramp may be used at the start of a session to quickly ramp from the previous session humidity level to the new setting, then remain substantially constant.
[0144] In some cases, the respiratory apparatus transitions the humidification level over a plurality of operating sessions. This adjusts the patient to the desired humidification level slowly, making the treatment more comfortable and the patient more adherent to the therapy set by the clinician. For example the respiratory apparatus may obtain one or more prior humidification parameters. Prior humidification parameters may include operating parameters of the respiratory apparatus relevant to the humidity produced. Based on the prior humidification parameters the respiratory apparatus can determine humidification parameters for the present session. One or more humidification parameters can then be set for a current session. In some cases these humidification parameters are configured to increase the humidity applied to the flow of gases to move toward the therapeutic humidity, which may have been identified by aclinician, over the current session. Over several sessions the therapeutic humidity can be reached.
[0145] For example, the respiratory apparatus may determine the humidification level reached in the prior session. This may be assumed to be a level of humidity at which the patient is comfortable. If this is below a therapeutic humidification level for the patient the respiratory apparatus may determine a transition for the humidification level for the present session, or a set of humidification transitions overthe present and future sessions - a plurality of sessions. The respiratory apparatus can then operate, in the present session, according to the determined humidification transition. For example, a transition may increase the humidification level by a ramp of humidity over the session so as to accustom the patient to higher humidity gradually and move, in part, towards the therapeutic humidification level. Where a set of session humidification transitions is used the set may be designed in combination so as to form the multi-session humidity transition. This transition may then be stored in the respiratory apparatus for future sessions. For example, each session transition may be configured to provide a comfort period (which may be below a previous operating humidification level) before increasing the humidity level towards the desired therapeutic level.
[0146] In some cases the apparatus (e.g. a controller in the apparatus) determines features and / or statistical features from the prior humidification parameters. The features may relate to the time period of previous sessions. The time period may be used to predict the length of a present session, and therefore a suitable session humidification transition. In one example the controller may set the present humidification parameters in an attempt to extend the length of a session. For example, the humidification level may be reduced at or near the previous end of session. This may increase the comfort of a patient and allow them to extend therapy.
[0147] In some cases the controller is configured to determine an event in one or more of the prior operating sessions. An event may be indicated by an unexpected ceasing of therapy, the removal of a patient interface, a patient indication of discomfort (as described above), humidification parameter changes by the user, or other unexpected or undesired occurrence during a therapy session. The controller may determine anunexpected event in the prior humidification parameters or may obtain an indication of the unexpected event. The controller may then set the humidification parameters or the humidification transition in an attempt to ameliorate the event. For example the humidity may be reduced at or near the time of the event (relative to the start of the session). For example the humidity may be increased slowly at or nearthe humidification level at which the event occurred.
[0148] An event, such as a change in an operating parameter, may indicate an adherence or comfort problem. In some cases the controller is configured to request the patient to identify a reason for the event or change in the operating parameter. This may be on detecting an event or a change in operating parameter. The request or user input may use the user interface on or associated with the respiratory apparatus. For example, if a patient interface is removed before the end of therapy, or therapy ceases before the expected end of a session, the respiratory apparatus may prompt the user. The prompt may request an explanation. The requested explanation may distinguish between patient comfort and another reason. For example, the respiratory apparatus may ask the user to push a button to indicate that the user has ceased therapy due to discomfort. This information can then be provided in the humidification parameters, or additionally, to allow the next session to be adjusted accordingly, or for the multi-session humidification transition to be adjusted.
[0149] In some cases the controller is configured to obtain respiratory apparatus parameters. These may include humidification settings, pressure settings, flow rate settings, water levels, time of day or other apparatus settings. The controller may use these operating parameters to set the one or more humidification parameters, in conjunction with the prior humidification parameters. For example the controller may receive the prior session parameters with a time stamp. In some cases this allows the controller to determine a time of day of the prior session. The time of day may be indicative of a length of session, or a type of session. For example if the time of day shows usage overnight, such as between 8pm and 6am, or 1 1 pm and 1 am, or midnight and 1 am, or other overnight period, the controller may determine the patient is using therespiratory apparatus overnight. The determination may be made over multiple sessions to determine a pattern of usage, such as long overnight sessions.
[0150] The determination of an overnight session allows the controller to configure the humidification transition to improve patient comfort. This may be by adjusting the humidity transition based on the determined prior session, or by adjusting the session humidity transition based on the determined current session. For example the controller may, for an overnight session, provide a low humidity at the start of the session to encourage the patient to sleep, slowly ramp overnight, and provide another comfort period before the patient is expected to wake up. This allows the patient to acclimatise to higher levels of humidity while having comfort at the beginning and end of the session. In some cases the controller may apply the same or similar determinations based on the length of time of previous sessions, overnight or otherwise.
[0151] The one or more humidification parameters are used to control the humidification of the flow of gases in the humidifier. In some cases a humidification set point is used as a parameter. A humidification set point is a user or clinician selected value indicative of a level of humidity intended to be provided by the humidifier. It may represent a desired humidity of the flow of gases at the outlet of the humidifier. However, the controller may adjust the desired humidity at a humidification set point based on, for example, external parameters. In some cases the humidification parameter is directly the desired humidification level at the output of the humidifier. In some cases a delivered humidity may be used. For example a humidity sensor at or after the outlet of the humidifier may determine the humidity actually provided to the patient. Other techniques or estimations may be used instead. In some cases the humidification parameter represents an average, maximum or minimum value. For example, the parameter may be a maximum humidity set point or humidification level reached previously. In some cases a time period may be used. For example, a time period at one or more humidification levels may indicate the amount of humidity the patient has become accustomed to. A longer time period would indicate more comfort at the higher level. Another operating parameter may be used instead of humidity. For example, thetime period may reflect the time spent at one or more humidification levels, or simply an operating or use time of the respiratory apparatus.
[0152] A prior humidification level is a humidification level of a prior humidification session. This level may have been determined to have been comfortable to the patient. This could be obtained by monitoring adherence during use of the apparatus, based on measured data or feedback, or by estimation. The prior humidification level may be referred to as a prior comfort humidification level, where it is a level of humidity where the patient appears comfortable. The patient, if provided the flow of gases at this level would likely be able to complete a session. However, the prior humidification level may not be sufficient for the therapy prescribed to the patient by a clinician (i.e. the humidification level may not be a therapeutic humidification level). Therefore the humidification level has to be increased. A gradual increase over one or more sessions (or over an extended period of time) can help adherence to the therapy. The prior comfort humidification level may be determined by a level reached in a prior session, such as a humidification set point, a desired humidity or other humidification parameter. The prior comfort humidification level may be a level at which the patient has received a flow of gases for a predetermined period of time. For example in the prior session there may have been a maximum humidity of 37 degree dew point, however if this was only provided for a short period of time the prior comfort humidification level may be lower.
[0153] Timing data from the one or more humidification parameters may be used to determine the prior comfort humidification level, or to set the one or more humidification parameters. For example, the controller may take account of a length of time of a session, or the length of time a prior session has operated at a humidification level, to determine the humidification parameters of the current session. Timing data may refer to a length of time, e.g. of operation of a humidification parameter, or a time of day (measured by a clock, timing device for example). Timing data may refer to the overall elapsed time of use, or operating time of the respiratory apparatus. In this way the humidification transition can be applied by determining the elapsed time of use of the apparatus and applying the appropriate humidification level.
[0154] In some cases the prior humidification parameters and the humidification parameters refer to the same parameter. This reduces the calculation required from the controller because, for example, a humidification set point of a present session can be directly compared to a humidification set point of a prior session. Alternatively the controller can convert between different humidification parameters. For example, the controller may calculate a desired humidification level for the present session based on the humidification set point of a prior operating session.
[0155] In some cases, the one or more humidification parameters define, or are used to define, the humidification transition. A humidification transition is a change in the humidification from a first humidification level to a second humidification level. In some cases the change is an increase or ramp. The increase or ramp may be used to acclimatise a patient to a higher humidification level. The humidification transition may comprise a change to a desired humidification parameter from the prior humidification parameters, or from a humidification parameter determined from the prior humidification parameter (i.e., an offset or proportional parameter).
[0156] In some case a humidification transition may be calculated by the apparatus (e.g., by a controller of the apparatus) based on the humidification parameters and / or prior humidification parameters. For example, the controller may obtain a prior humidification set point of 34 degrees and determine a humidification transition to lift this to a humidification set point of 37 degrees over one, or more, sessions. In some cases selecting an initial humidity below the prior session humidity provides an increased feeling of comfort to a patient because they have adjusted to the feeling of a higher level of humidity. The humidity can then be increased over one or more sessions without a feeling of continual increase.
[0157] An example method of devising a humidification transition is to determine an initial humidification level, based in part on the prior comfort humidification parameters for example, and a desired humidification level, based in part on a therapeutic level for example. The therapeutic set point could be determined by a clinician. The clinician could input the set point into the controller. The humidification transition may then be a transition between these two levels. In some cases the transition starts or end at theselevels. However in some cases the transition may be related to, but different to, these levels. For example, the transition may start at a humidification level below the initial humidification level to improve comfort. For example the transition may only change partially to the desired level in one session, so as not to change the humidity too quickly. In some cases the controller may determine a multi-session transition spanning a plurality of sessions to allow the desired humidity to be reached more slowly.
[0158] In some cases the respiratory apparatus has an adherence parameter to detect the adherence of a patient during use of the device. For example the adherence parameter may monitor a session length. If the session length is shorter than a predefined or prescribed length the adherence parameter may be changed. In some cases the adherence parameter may comprise a signal that a patient interface was removed during the session for an extended period of time. Again, this may indicate poor adherence or poor comfort. In some cases the adherence parameter may comprise the number of times the patient requested the humidity to be reduced or the length of time for which a patient interface was worn. Other measures of adherence may be used.
[0159] By monitoring adherence of the prior sessions (or the current session) the controller can determine how well the patient tolerated the prior session humidity and adjust, if necessary, the humidity or humidification transition of the current session to improve patient comfort. In some cases only the immediately prior session is considered, but where multiple prior session information is available the controller could consider how a patient has adhered to different humidification levels and determine a humidification transition or humidification parameters to encourage adherence while increasing humidity. For example, if poor adherence was shown in a prior humidification level the controller may spend an initial time period at a lower humidity before beginning to increase the humidity so as to encourage improved compliance.
[0160] A multi-session humidification transition may be a step increase from an initial humidification level to a desired humidification level over multiple sessions, or may be a more complex function relating the initial to desired humidification levels. In some cases the increase is an increment. For example, the humidity may be increased by an increment towards the desired humidification level. For example, between each sessionor after a predefined period of time at a humidification level (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 hours). The increment may be predefined, such as a 1 degree C dew point increase. In some cases the increment is variable. The increment may be larger when there is a large difference between the initial and desired humidification level and then reduce as the desired humidification level is approached in later sessions. This means the patient approached the therapeutic humidification level more quickly. The increment may be relatively small when close to the initial humidification level and increase as the desired humidification level is approached, because the patient is adapting to greater levels of humidity. The controller may look the prior humidification data to identify the previous increment and maintain or modify the previous increment.
[0161] The increment may depend on the time period or predicted time period of a session. For example, the increment may be smaller if the session has a shorter length, so as to reduce the feeling of a sudden change, or to provide time for a patient to adapt. The increment may depend on the adherence parameter of the prior session. Where the prior session was not adhered to the increment, if any, may be reduced to encourage better adherence. In some cases the increment, including optionally how the increment varies, may be set by the clinician. This allows the clinician to consider how to improve the therapy for the patient. A predicted time period of a session may be used where the length of a session is not fixed, or where the apparatus does not have information of the session length.
[0162] In some cases the controller determines a multi-session humidification transition spread over a plurality of sessions. This can be considered as the controller creating a plurality of session humidification transitions, with the overall effect of the session humidification transitions being the multi-session humidification transition. In this way the controller can create a structured approach to moving the patient to the therapeutic humidification level or the controller can use multiple sessions to reduce the rate of change of humidity experienced by the patient. Each session humidification transition may be equivalent to a humidification transition as described herein. The session humidification transition may have an initial and desired humidification level and the transition between these may be, for example, a single increment, a ramp, a series ofsteps or other profile over the length of the session. This provides substantial flexibility to the controller to increase humidity while maintaining patient adherence and / or comfort. Each session may have a final humidification level, the humidification level reached in that session. In a complete session this would be the desired humidification level. The final humidification level may increase in each session of the series of sessions. This allows the humidification level to be increased over the series of sessions which may increase the comfort of a patient as they gradually acclimatise to the humidification level in each session. However, because multiple session humidification transitions may be used, more complex patterns may be used, if helpful. For example the same humidification transition may be repeated in consecutive sessions or there may be sessions in which there is no increase in humidification level. These changes may depend on patient adherence in prior sessions or may be transitions found to provide patient comfort.
[0163] Where the multi-session humidification transition is divided into a plurality of session humidification transitions the humidification level, or size of increase in each session and / or rate of change of humidity may be constant in each sessions. Alternatively, the rate of change of humidity may increase or decrease in each session, similar to the increments described above. There may be increments in humidity or rate of humidity between sessions. Each of the session humidification transitions may have a humidity profile. For example, one or more steps, a ramp, a constant increase over the session, an increasing or decreasing rate of increase. In some cases the session humidification transition occurs in a fixed time period within the session.
[0164] The session humidification transition may use the entire length session, or part of a session. The part of the session may be an initial part of the session, the final part of the session or an intermediate part of the session. In some cases the session humidification transition uses the entire session but initial and / or final periods of the humidification transition are configured for warm-up or cool-down. The time period for the session humidification transition may be 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes or 180 minutes, for example. By selecting a time period the rate of change and the length of time in which a patient may become aware of a humiditychange can be controlled. For example, a patient may feel more comfortable if the humidification level is not being changed, so a shorter transition time period is used. However, a patient may feel more comfortable if the humidification level is changed more slowly, so a longer transition time is used. In some cases the humidification transition is divided into a plurality of steps within the session. This can provide a series of fixed humidification levels in between the steps or increments. The transition time could be defined by one or more of a clinician, a user, or the apparatus (e.g., automatically).
[0165] The parameters of the session humidification transitions may be determined by the prior humidification parameters. For example the time period of the transition may be determined based on the length of the prior operating sessions, such as assuming a similar length of session and determining a suitable humidification transition forthat time period. Statistical measures such as minimums, maximums, means, averages of lengths of the prior sessions may be used. Some example profiles for humidification transitions and / or session humidification transitions will be described below with reference to the drawings.
[0166] In some cases the controller determines (or is provided) a time period in which to complete a multi-session humidification transition. The controller then adjusts the humidity in each session depending, at least in part, on the elapsed time. In this way the length of individual sessions does not affect, or at least has a lesser effect on, the humidity transition. For example, a patient having a 4-hour session would receive substantially the same transition as a patient have two 2-hour sessions. The controller would not restart or move to a new session humidity transition because of the break in sessions. In some cases the initial and / or final periods mentioned above may be used at the start of any session to provide additional comfort, without being considered part of the humidity transition. If equally sized in each case these would make the two 2-hour sessions have a slightly smaller transition time than the single 4-hour session. The humidity transition may have a series of partial transitions over the time period. For example, rather than a single ramp there may be a combination of partial humidification transitions (e.g., ramps, increments or curves) which do not span the initial to operating humidification levels, butwhich combine to form the overall transition. The partial humidification transitions may span expected session lengths.
[0167] The respiratory apparatus may have a user interface or communications interface to allow an input humidity to be received. The user interface may be on the respiratory apparatus. For example the user interface may comprise a touchscreen and / or buttons. For example the respiratory apparatus may have one or more buttons allowing a humidity set point to be selected by a patient or clinician. The user input may be understood as the desired humidification level, for example a 37 degree dew point. In some cases this can then be compared to the prior humidification parameter, which may be a 31 degree dew point. The controller may then determine a humidification transition of one, two or a plurality of sessions to make the change in humidification parameter more comfortable for the patient.
[0168] The user interface may be configured to set one or more humidification parameters, or a humidity transition, or to alter preset humidification parameters. In some cases the respiratory apparatus may receive a humidification transition, or a plurality of session humidification transitions, from the user input. These may be selected by a user from a plurality of predefined transitions, the controller may be able to adjust the transitions depending on, for example, adherence, or a user / clinician may provide specific transitions. By allowing a humidification transition to be communicated the respiratory apparatus allows a clinician to closely control the therapy, if required. The preset humidification parameters may be stored in memory of the respiratory apparatus. These may be stored in non-volatile memory on the device to provide, for example default comfort settings.
[0169] The user interface may be remote from the apparatus. The communications interface may comprise a wired or wireless communicator. The communications interface may comprise a wireless controller such as a cellular controller or Wi-Fi™ controller. The communications interface may allow an electronic input to the respiratory apparatus. For example the communications interface may be configured to receive an input from a remote computing device such as a server. A clinician may access the server and set a therapeutic humidification level, or humidification transition. The apparatus may thenreceive this information from the server and determine or apply the humidification transition.
[0170] For example, the communications interface may be configured to receive an input from a personal electronic device, such as a cellular phone or a tablet. The personal electronic device may be connected (e.g., wired or wirelessly) to the respiratory apparatus. The user may specify an input on the personal electronic device, for example in an application. The personal electronic device may transfer the input to the respiratory apparatus. In some cases, the personal electronic device may also contact a remote computing device, such as a server. For example a server may confirm the parameters are suitable and / or request authorisation from a clinician.
[0171] In one example the clinician determines a respiratory therapy for a patient. The clinician may log into an application to set humidification parameters for the therapy, which are then sent remotely to the respiratory apparatus. The user may review the humidification apparatus on their phone to understand the therapy. After several sessions the clinician may consider adherence data and update the humidification parameters on the server, which are again sent remotely to the respiratory apparatus. In some cases the user may also be able to adjust one or more humidification parameters.
[0172] The respiratory apparatus may be configured to detect and / or receive an indication of patient discomfort. The respiratory apparatus may implement one or more response actions based on the indication of patient comfort. The response actions may be within the session or may affect a plurality of the multi-session transition. An example response action is to reduce the humidification level. A response action may lead to a modification of the session humidification transition, or of the multi-session humidification transition.
[0173] An indication of patient discomfort may be received through a user interface. The respiratory apparatus may have a user interface to allow a patient to feedback on their level of comfort and / or provide feedback to the respiratory apparatus. For example, if the patient is experiencing discomfort, they may push a button on the machine. Other user indications are possible, for example patient interface removal. Other methods of receiving discomfort information may be used.
[0174] The controller may report user indications of discomfort or adherence to a clinician. This may be dependent on user input and / or automatic. The response action to the patient indication of discomfort may be dependent on clinician settings. For example, the clinician may disable the functionality. Where the response action to the patient indication of discomfort is a decrease the session humidification transition or multisession humidification transition may be modified to implement increases.
[0175] Based on the user comfort input, or a series of user comfort inputs, the controller may apply one or more response actions, such as adjusting the humidity parameters and / or the humidification transition. The response action may be a modification to the session humidification transition, and / or the multi-session humidification transition. For example the humidification level may be reduced, or the desired humidity of the session humidification transition may be reduced. By reducing the humidity or the speed of change of the humidity the controller may improve patient comfort, and therefore adherence during the session. The controller may consider other patient feedback, if available, to control the one or more humidification parameters.
[0176] In some cases, the controller reduces one or more of the current humidification parameters as a response action to the patient indication of discomfort. The reduction may be determined to improve patient comfort and / or adherence. The reduction may be a predefined reduction in humidity, such as one degree C lower dew point. Other predefined reductions may be at least seven degrees, up to seven degrees, up to five degrees or up to 3 degrees C of dew point. The predefined reductions may be 2, 3, 4, 5, 6, or 7 degrees C of dew point, for example.
[0177] In some cases the controller determines a length of time to remain at the reduced humidification level forthe response action. In some cases the controller reduces a rate of increase in humidity from the reduced humidification level for the response action. This may allow the humidity to reach, or at least move towards, the desired humidity, while increasing comfort, reducing discomfort or increasing adherence because the humidity changes less quickly.
[0178] The response action of the controller to the patient input indicating discomfort may depend on the point in the humidification transition. For example, if the patient isnearing the end of the transition the transition may be paused until the following session. If the patient is at the start of a transition the transition may be slowed, or the number of sessions of the transition may be increased, to allow the patient to acclimatise to the humidity at a more comfortable rate. The response action to the patient indication of discomfort may depend on the humidification level and / or the number of indications. For example, a reduction in humidification level may be smaller at higher humidification levels (or humidification levels closerto the prescribed humidification level). For example, if further indications of discomfort are received further reductions may be smaller. The reductions may be progressively smaller. In some cases, the response action may be a pause in the transition, which may act as a snooze function.
[0179] In some cases the response action may be a lowering of the desired session humidification level of the session, or a lowering of the prescribed humidification level. This may require clinician authorisation. In some cases the humidification transition may be stopped, with the current level set as a final (or updated desired) level. In some cases the modification is temporary - for the current or a predefined number of sessions, or for a period of time. In some cases the controller applies a plurality of response actions. In some cases a response action is selectable by the user. In some cases the controller is configured to select a response option. In some cases the applied response action depends on predefined rules.
[0180] After a response action has modified the humidification level of the session the session humidity transition and / or the multi-session humidity transition may also be modified. The modification of the transitions allows the controller to account for and / or offset the modification. For example, the session humidity transition and / or the multisession humidity transition may be modified so as the response action slows the number of sessions remains the same, or the modification may ensure the increment between sessions remains the same or the rate of increase of humidity remains the same. For example, the response action may cause a repeat of the intended session humidity transition. The modification of the transition may depend on the response action, and / or the number of response actions.
[0181] A modification of the session humidity transition may be temporary. The controller may attempt to return to the desired session humidity transition after the modification, to acclimatise the patient in the desired period of time. This means that the modification is reversed within the same session, and / or the following session(s) are not impacted. For example, the modification may only be applied for a portion of a session. The modification may reduce the session target humidification level but increase the increment to the next session to compensate. The modification may increase the rate of increase of humidity in the session to account for the reduction. The subsequent increases may completely offset the reduction in humidity. The increases may mirror the reductions or may be configured to increase comfort.
[0182] A modification to the multi-session humidification transition may maintain one or more features of the multi-session transition. For example, the number of sessions or the increment between sessions orthe rate of increase of humidity may be held constant. This may require modifications to other parameters. For example, the time period of the session humidification transition in following sessions may be increased. This reduces the rate of change but increases the length of the following sessions. For example, the number of sessions may be increased. The provides additional time to transition to the desired humidification level. If the number of sessions is increased the increment between sessions may need to be correspondingly reduced. The desired humidification level of the multi-session transition may be decreased (this may need to be confirmed with a clinician).
[0183] In one example the next session of the multi-session transitions begins from the humidification level at which the modification took place in the present session, or the point at which the patient indication of discomfort was received. In one example the increments between the remaining sessions are reduced, the number of sessions is increased and / or the desired humidification level is decreased. Decreasing the desired humidification level may allow the number of sessions and future increments to remain constant but may require clinician approval. If the final humidification level was raised the inverse actions could be applied. In a further example the controller may modify the session transitions of the multi-session humidification transition. For example, the rate ofincrease of humidity may be decreased (or the time period of a session transition may be increased). This provides more time for a change within the later session. For example the number of sessions may be increased, the overall time period of the transition may increase or the size of increments between sessions may decrease.
[0184] In some cases the multi-session humidification transition is modified dependent on a time between sessions. Modification may occur if the length of time (e.g. spacing) between sessions is too large. For example if sessions are spaced apart by more than a predefined length of time, or if there is a calendar of sessions and one or more of the sessions are not started or not completed (e.g. missed sessions). The modification may depend on the length of time between sessions, or the number of sessions missed. For example missing a single session may have a different modification to missing a plurality of sessions, or a multiple day gap between sessions may have a different adjustment than a single missing day. Example modifications include restarting the multi-session humidification transition. This may return to the initial level or recalibrate the multi-session humidification transition based on a new comfort level. A prior session may be repeated, or a predefined or determined number of prior sessions may be repeated. The initial session humidity may be decremented. The decrement may depend on the length of time between sessions. The decrement may be limited by the initial humidity and / or a clinician setting. The modification may cause further adjustments to the multi-session humidification transition.
[0185] In some cases the user (e.g. a patient or clinician) may be prompted for an input to confirm whether the modification should occur. In some cases the controller may receive an input that one or more sessions have occurred on a different respiratory device and / or for a different respiratory therapy. The controller may request a reason for the adjustment or lack of adjustment. In some cases a server may store prior session information from one or more respiratory devices and provide this to the controller. In some cases the modification may occur on determination of a lack of adherence. For example, the controller may determine a session has been missed or determine an extended length of time between sessions. In some cases the modification t may occur if there has been poor adherence in sessions. For example a patient may start a session,but the session may be short due to a patient interface being removed. The length of time between sessions may comprise a length of time between sessions of sufficient session length. The sufficient length may be predefined.
[0186] The respiratory apparatus is configured to provide high flow therapy. However, some patients used both high flow therapy and a pressure-controlled therapy, such as positive airway pressure therapy (PAP). Examples of PAP include Non-invasive ventilation (NIV), Continuous positive airway pressure (CPAP) and / or Bi-level therapy. Moving between these therapies can be uncomfortable because of the change in humidity required for high flow therapy. A humidity therapy transition may be used when a change in therapy is detected. A change in therapy may be detected when the patient interface is changed. This is because CPAP uses a sealed interface to control the pressure while high flow therapy uses an unsealed interface. The humidity therapy transition may be designed to change from the humidity of CPAP to the humidity of high flow therapy in a comfortable manner. Moving from PAP therapy to HFT can increase mucus clearance (due to the increase in humidity), increase respiratory support, increase oxygen delivery and / or reduce physical exertion of breathing.
[0187] Typically the therapeutic humidity level in PAP is lower than NHF. In some cases this affects a patient's acclimatisation to NHF, in particular where they are switching between NHF and PAP therapies. A patient may use NIV at night and NHF during the day. In some cases the operating parameters of the NHF and PAP will be controlled separately. In some cases a transition will be used for NHF, but the PAP humidity will be set at the desired therapeutic value for the patient treatment without requiring a transition. It is possible that both use humidification (operating parameter) transitions as described herein (both or either of multi-session and session humidity transitions). The transitions may be linked or independent. For example a first transition may be applied to NHF and a second transition applied to PAP. The second transition may be dependent on the first transition. For example, the humidification level of the second transition may be a fixed portion of the humidification level of the first transition; or may be a predefined amount less than the fixed portion (e.g. x degrees less dew point). Where multi-session transitions are used for both therapies the number of sessions, or the time-period of themulti-session transition may be smaller for one therapy (e.g. PAP) than the other (e.g. NHF).
[0188] The multi-session humidification transition and / or a session humidification transition may change depending on a type of session. An example type of session may be a day or night session. For example, a first type of session may have no increment (i.e. a constant parameter level between sessions), with the ramp only occurring in a second type of session. For example, the first type of session may have a constant humidity level (but may increase between sessions of that type) while the second type of session has a session humidity transition. For example, the desired or therapeutic humidity may be a first value in the first type of session and a second value in the second type of session, where the first value may be higher or lower than the second value. In some cases the first type of session and the second type of session have independent humidity transitions. For example the first type of session may increase at a first rate to a first humidity level and the second type of session may increase at a second rate to a second humidity level. The first rate may be lowerthan the second rate. The first humidity level may be higher or lower than the second humidity level. In some cases, the adherence to a particular type of session is used to change the humidity transition of only that type of session.
[0189] In some cases the humidity transition of the first type of session is, at least in part, dependent on the second type of humidity transition. For example, poor adherence in the first type of session may lower the initial humidity of the second type of session. In some cases different types of session may have different and / or additional adherence measures. For example, a night session may determine adherence (or comfort) by patient sleep and / or wake lengths or times. In some cases these may be determined by sensors on the respiratory apparatus. For example the determination may be through respiratory rate, breath detection and / or movement. In some cases on detection of waking, or prediction of waking the humidity level may be altered. For example, the increase may be paused while the patient is awake. Alternatively, a large increase may occur when the patient is awake. In some cases the humidity transition time period may be shortened(i.e., by increasing the rate) so as to complete before the patient wakes. This can account for suboptimal night ramps.
[0190] Considering night / day sessions specifically, the therapeutic humidification level for a day and a night session is typically the same. However, in some cases patients will adjust humidity levels within a range depending on day / night usage. In some cases the transition may change depending on whether the session is a day session or a night session. For example it may be advantageous that there is no humidification transition for a day session, but may be one for the night sessions, or vice versa. In some cases one or more of the rates of increase, the length of time of the transition or other transition parameters may be different. For example higher temperatures may wake up patients at night while sleeping. Therefore the therapeutic temperature may be lower at night than during the day. In some cases a therapeutic temperature range is provided to a patient, with the patient selecting day / night therapeutic temperatures within the range. Similarly the tolerance of humidity may differ between night and day, so that the therapeutic temperature is lower. These factors lead to a balance between providing optimal therapy level and ensuring comfort for compliance / adherence.
[0191] In some cases the type of session may be seasonal. For example the first type of session may be a wet seasons session and the second type of session may be a dry season session or vice-versa. For example the type of session may be a warm seasons and / or a cold season. The season may be determined based on the location and / or date setting of the respiratory device. In some cases the respiratory apparatus may determine one or more ambient measurements. For example a temperature and / or humidity and / or pressure of the environment. These may be determined by one or more sensors or otherwise determined or received. These measurements may adjust the type of session based on the environment in which the respiratory apparatus (and the patient are located). For example, this may adjust the humidity transition dependent on if a warming device (such as a fireplace or air conditioner) is on. In some cases one ambient measurement may be used to estimate further ambient conditions. For example, pressure may be used to estimate ambient temperature and / or humidity- as higher altitudes tend to be colder and drier.
[0192] In some cases the controller adjusts the humidification parameters based on a resource constraint. The resource constraint may be a determined water level of the humidifier, or power remaining in battery. The controller may adjust the session humidification transition to conserve enough water for the expected length of the transition and / or session. This ensures that the humidification transition is able to be completed by the humidifier. The controller may have to estimate a resource usage amount for the humidification transition and adjust one or more parameters to reduce the resource usage. For example reducing a humidification level or flow rate.
[0193] In some cases the controller adjusts the humidification parameters based on an input. This may be a patient and / or clinician input. For example a manual input. Alternatively physiological data and / or patient feedback may be used to determine to adjust the humidification parameters. For example the controller may allow a therapeutic bypass. This may be applied on the patient or clinician request, or based on physiological data, for example, if breathlessness and / or excess mucus is determined. The therapeutic bypass stops the operating parameter transition to provide the therapeutic operating parameters. The therapeutic bypass may interrupt the transition for a single session, or part thereof. The therapeutic bypass may interrupt the transition until re-initiated. When the therapeutic bypass is stopped the multi-session humidification transition may be adjusted based, in part, on the adherence to and / or length of the therapeutic bypass. Alternatively the multi-session humidification transition may continue from the point at which the therapeutic bypass occurred.
[0194] During a current session the controller may be configured to record one or more humidification parameters. This creates a record of the session. The record can be referred to in future sessions to create the session humidification transition for the future session. The controller may record the humidification parameters at regular intervals during the session. In some cases the controller provides summary or statistical data on the humidification parameters during the session. For example the controller may indicate the length of time at one or more humidification levels.
[0195] The prior system has been described as the respiratory apparatus receiving prior humidification parameters and determining humidification parameters or thecurrent and optionally future sessions. However the respiratory apparatus may also determine a multiple session humidification transition based on user inputs and then apply the determined humidification transition over the multiple sessions. In some cases this reduces the processing required by the controller because the humidification transition is determined once. However, in some cases the controller may still modify the humidification transition once determined based, for example, on patient comfort inputs and / or adherence. In another example the respiratory apparatus may have a preset humidification transition. This may be adjustable by the clinician and / or patient.
[0196] There are various examples of a respiratory apparatus that can operate in a manner to assist patient to acclimatise to the operational level of gas flow humidification parameters. For example WO2019070136A1, incorporated herein by reference, shows a suitable respiratory apparatus. A respiratory apparatus will be described, and then a general example will be described (with examples) in which the respiratory apparatus is configured to implement the humidity acclimatisation. Then several examples will be described. These should not be considered limiting to other variations that could be conceived still provide the described acclimatisation.
[0197] The various actions, parameters etc. for any particular example described are not necessarily restricted to just that example and could be used in combination with other examples. The example described are not exhaustive of implementations, and neither are they necessarily independent from each other.
[0198] Figure 1 shows a general example of a respiratory apparatus 10 that uses a conduit 55 with a heater wire 58 and patient interface 51 (sealing or unsealing / non- sealing, depending on use as explained later - a non-sealing is shown in Figure 1) to provide a gas flow 31 to a patient to provide respiratory support - which can comprise pressure therapy / support and / or optionally flow therapy / support and / or optionally humidification support (see later). The respiratory apparatus 10 is configured for delivering a gas flow 31 at a desired pressure and / or flow rate. The breathing gas can be humidified, for example by humidifier 52.
[0199] The apparatus has a controller 19 that can be configured to control the operation of the respiratory apparatus 10. The controller 19 can control the apparatus tocontrol the pressure, flow rate, temperature, humidity, oxygen fraction and / or any other operating parameter of gas flow using any suitable control method. To do this, a controller 19 can implement a pressure control method and / or a flow control method to adjust the pressure and / or flow rate and can implement a humidity control method and / or an oxygen fraction control method. For example, the controller 19 can control components of the respiratory apparatus 10, including but not limited to: operating a flow generator 50B to create a flow of gas (gases flow) for delivery to a patient, operating a humidifier to humidify and / or heat the generated gases flow (e.g. by controlling a heater plate of the humidifier), controlling a flow of oxygen into the flow generator 50B blower, operating a heater wire 58 to control temperature and humidity, controlling an oxygen fraction in the gas flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory apparatus 10, and outputting information (for example, on the display 54) to the user. It will be appreciated that herein the apparatus 10 undertaking an action, may comprise the controller 19 controlling one or more components of the apparatus 10 to undertake the action.
[0200] The respiratory apparatus 10 could be an integrated in a single housing such as the dashed box 1 1 , or a separate component based arrangement, generally shown by the individual components within the dotted box 1 1 in Figure 1 . In some configurations, the apparatus 10 could be a modular arrangement of components 19, 52, 50B. As such, the apparatus could be referred to as a "system", but the terms can be used interchangeably without limitation. Hereinafter it will be referred to as an apparatus, but this should not be considered limiting. If the apparatus 10 is integrated in a single housing, there are advantages of convenience, ease of use, less likely to lose components (especially in a busy hospital environment), improved compliance and the like. It also provides easier humidity and flow control as there is a short flow path between the flow source 50B and humidifier 52.
[0201] Where the apparatus / system 10 is multiple separate components, those components may not be dedicated for use with each other. For example, the disclosure herein could cover use of a standalone humidifier 52, which might be connected to an external flow source 50, e.g. hospital flow source, that itself might be designed for usewith different respiratory apparatus. In this case, the humidifier 52 alone (optionally including one or more sensors) might be considered a respiratory apparatus 10, even before being connected to the flow source, and herein is deemed covered by the term "respiratory apparatus" 10.
[0202] The apparatus 10 may comprise any suitable apparatus used for high flow therapy. This provides both high flow rates and humidification for comfort. However, the respiratory apparatus 10 may also be configured or configurable to provide one or more pressure-controlled therapies such as CPAP or Bilevel / N IV therapies or the like. This provides additional flexibility to the use of the apparatus 10. For example the apparatus may be a multi-therapy apparatus that can provide Nasal High Flow (NHF) therapy and any combination of one or more of: humidifier respiratory therapy, Continuous Positive Airway Pressure (CPAP) therapy and Non-lnvasive Ventilation (NIV) e.g. Bi-Level pressure therapy. In other cases the apparatus 10 is configured to provide any therapy requiring a relatively high flow rate and humidification of the gases flow. The apparatus 10 may comprise one or more control modes associated with each therapy type. That is, one apparatus 10 can provide any two or more of the therapy types. Alternatively, the apparatus 10 could be dedicated to just one or some of the therapies. The control modes may be manually selected by the user or automatically selected depending on the components connected to the apparatus (for example dependent on the type of tube and / or patient interface connected to the apparatus). Each control mode may have an associated control method for controlling components of the apparatus (for example the flow generator, humidifier heater or conduit heater).
[0203] Figure 1 shows various components that can be present for providing high flow therapy and / or humidification therapy. The components may also be able to provide other therapies such as CPAP, Bilevel / N IV and pressure-controlled therapies and / or flow- controlled therapies. Not all components might be necessary for any particular apparatus. An unsealed cannula is shown as an example patient interface 51 , but as noted, the apparatus 10 can be configured for one or more other therapies including pressure and / or flow control and / or humidification therapies and a sealed interface might be used instead as appropriate. In some cases the apparatus 10 is capable ofdetermining, or being signalled, the type of patient interface attached to the system and operating an appropriate therapy.
[0204] The apparatus 10 comprises a flow source 50 for providing a high gas flow 31 such as oxygen, or a mix of oxygen and one or more other gases, providing an oxygen fraction of the gas flow, or more generally a gas fraction. Alternatively, the apparatus 10 can have a connection for coupling to a flow source 50. As such, the flow source 50 might be considered to form part of the apparatus 10 or be separate to it, depending on context, or even part of the flow source 50 forms part of the apparatus 10, and part of the flow source fall outside the apparatus.
[0205] The flow source 50 could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and / or a high flow therapy apparatus with a blower / flow generator 50B. Figure 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an 02 source (such as tank or 02 generator) 50A via a shut off valve and / or regulator and / or other gas flow control 50D, but this is just one option. A blower 50B in a home environment may monitor the humidity at the input, or prior the humidification chamber. The input humidity may be used to control the humidity added by the humidifier, to meet the controlled humidity level. The flow source could be one or a combination of a flow generator 50B, O2 source, air source as described. The flow source 50 is shown as part of the apparatus 10, although in the case of an external oxygen tank or in-wall source, it may be considered a separate component, in which case the apparatus has a connection port to connect to such flow source 50. The flow source 50 provides a high flow rate controlled and, optionally, pressure-controlled flow of gas that can be delivered to a patient via a conduit 55, and patient interface 51 .
[0206] In some configurations, the respiratory apparatus 10 may not comprise a flow generator 50B. In this case the apparatus 10 does not generate a flow of gases, and instead is configured to be connected to an external flow generator and configured to humidify the flow of gases from the external flow generator. For example, the respiratory apparatus 10 can be used as a stand-alone humidifier 52 to humidify the flow of gases flowing through the respiratory apparatus 10. The flow generator may be a wall gas supply (regulated via a flowmeter or rotameter, for example) other separate flowgenerator that can be configured to provide one of the therapies described elsewhere in the specification (e.g., NIV, Bilevel, NHF, CPAP, humidification therapy etc). A patient or user could select one or more of these therapies / modes.
[0207] The conduit 55 can have a heater wire 58 that is controllable to heat gas in the conduit 55. The heater wire 58 may be integrated into a wall or bead of the conduit 55. Alternatively the heater wire 58 may be freely placed within the lumen of the conduit 55. The conduit 55 is coupled or couplable at one end to a gases outlet of a water chamber 57 of a humidifier 52 in the housing 1 1 of the respiratory apparatus 10. Depending on the end-use, the patient interface 51 may be any suitable interface coupled or couplable to the apparatus 10 including one or more of: an unsealed (also termed "non-sealing") interface (for example when used in high flow therapy) such as a nasal interface (cannula), with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or endotracheal tube, and / or a tracheostomy interface, or any other suitable type of patient interface; or a sealed interface (for example when used in NIV, CPAP) such as a nasal mask, full face mask, or nasal pillows.
[0208] A humidifier 52 with a water chamber 57 and base / heater plate 59 can be provided between the flow source 50 and the patient to provide humidification of the delivered gas. This could be a humidifier integrated with the flow source 10 to form an integrated apparatus 11 (see dotted lines) or separate but attachable / detachable to / from the flow source 10 (e.g. flow generator). The heater plate may be or comprise a heater element, or heating surface, or other apparatus suitable for imparting heat to a liquid, such as water. The heater plate 59 may have an exposed heating surface, be formed from a plurality of layers including at least one heating element, and / or form part of the base of the humidifier 52. In each case the heater plate 59 is configured to evaporate water, whether from a water chamber 57 directly, from a dosed amount of water placed on the heater plate, or otherwise.
[0209] Alternatively, the humidifier 52 could be a standalone humidifier (connectable / disconnectable to / from the flow source) with a water chamber 57 and base, where the humidifier 52 is coupled to the flow source 10 via conduits 61 or other suitable means. The humidifier 52 may comprise the heater plate and a humidification chamber.A humidification system may comprise the humidifier and a further heater, such as the heater wire. The external heater, such as the heater wire may be controlled by the controller of the humidifier. The apparatus 10 (or the humidifier 52 when standalone) may comprise one or more sensors 53A-E and a humidifier controller that is configured to control the humidifier based on the sensor measurements. The humidifier controller may be the same as, combined with, part of, or linked to the apparatus controller 19. Where a controller is discussed herein it will be understood this may refer to the humidifier controller, the apparatus controller or any controller configured to control part of the apparatus.
[0210] The humidifier 52 may comprise a temperature sensor 53A and a flow sensor 53B. The shown positions should not be considered limiting. The, or the plurality of, sensors may be located between, within, before or after the flow generator 50B and / or humidifier 59. The humidifier 52 can humidify the gases flow and / or heat the gases flow to an appropriate humidity / temperature level. The controller (for example apparatus controller 19) can be configured to control the humidifier 52 (for example, by controlling at least a humidifier heater plate).
[0211] The humidifier 52 may be optional, or it may be preferred due to the advantages of humidified gases helping to maintain the condition of the airways. Humidification is optionally used with high flow gas flows to increase patient comfort, compliance, support and and / or safety.
[0212] The heater wire 58 can be controlled by the controller 19 to heat the gas flow 31 to further control the temperature and / or humidity of the gas flow.
[0213] One or more sensors 53A, 53B, 53C, 53D, 53E, 14 such as flow rate, oxygen fraction, pressure, humidity (dew point, RH or AH), temperature, presence, or other sensors can be placed throughout the apparatus and / or at, on or near the patient. Alternatively, or additionally, sensors from which such parameters can be derived could be used. In addition, 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), partial pressure of oxygen in the blood, respiratory rate, partial pressure of 02 and / or CO2 in the blood. Alternatively, oradditionally, sensors from which such parameters can be derived could be used. Other patient sensors could comprise EEG sensors, torso bands to detect breathing, and any other suitable sensors.
[0214] One or more of the sensors might form part of the apparatus, or be external thereto, with the apparatus having inputs for any external sensors. The sensors could be in any suitable place for what they are sensing, comprising, but not limited to: flow generator or source inlet or outlet, humidifier inlet or outlet, heater plate 59, conduit 55, patient end of conduit (end of hose "EOH", where the conduit connects to the patient interface tube), patient interface 51 and / or patient. Figure 1 shows a sensor 53A at the output of the flow generator, and a sensor 53B between the flow generator and the humidifier. Sensors 53A and 53B are shown on conduit 61 . Sensor 53B may be arranged at the inlet to the humidifier 52. Sensor 53C is arranged at the outlet of the humidifier, or at the inlet of the conduit 55. Sensors 53D is arranged on the conduit 55. In some cases it may be at or towards the patient interface 51 end of the conduit. Sensor 53E is configured to attach to the patient. Further sensors may be used where helpful, for example to provide good feedback to controller 19 or sense a parameter of the gases flow. In some cases an ambient sensor is located before the flow generator 50B.
[0215] The output from the sensors 53A, 53B, 53C, 53D, 53E, 14 may be sent to controller 19 to assist control of the apparatus 10, comprising, among other things, to control: the flow generator 50B, or flow source 50, to control flow rate and / or pressure of the gas flow; the humidifier and / or heater wire to control temperature and / or humidity of the gas flow; and the oxygen fraction of the gas flow alternatively, or additionally, input could come from a user.
[0216] The controlled parameter such as humidity, temperature, flow, pressure, oxygen fraction or the like can be controlled (i.e. measured and attempted to set a specific levels) at any suitable point, such as at the end of the breathing conduit 55, at the patient interface 51 , at the gases outlet, a humidification chamber outlet, at any sensor 53A to 53D of the apparatus, any other place where the sensor(s) might be as noted above and / or any combination thereof. The parameters can be controlled to a set point (target). These set points could comprise (just a small subset of examples withoutlimitation), a desired dew point (for example a temperature indicative of a desired humidity), a predefined dew point, a predefined temperature, a desired temperature. The set point may be a specific humidification level or may represent a humidification level but differ from the represented humidification level based on operational conditions.
[0217] The controller 19 may be coupled to the flow source 50, humidifier 52 and sensors 53A to 53E and / or any other component to achieve control. It controls these and other aspects of the apparatus to be described below.
[0218] The controller 19 can also control any other suitable parameters of the flow source 50 to meet oxygenation requirements / fraction - such as mixing valves such as a proportional valve. The controller 19 can also control the humidifier 52 based on feedback from the sensors 53A-53E, 14. Six sensors are shown by example but any suitable number could be used and placed anywhere suitable. Using input from the sensors, the controller 19 can determine oxygenation requirements and provide information to a medical professional (who may control the components of the respiratory apparatus 10 to provide the desired therapy, e.g. flow rate, 02 fraction, humidity, etc.) and / or control parameters of the flow source, temperature and / or humidifier as required.
[0219] The controller 19 is also configured to operate the apparatus 10 so that the flow, pressure, volume and / or other parameters of gas provided by the flow source based on feedback from sensors, or optionally without feedback (e.g. using default settings). The controller 19 can also control any other suitable parameters of the flow source 50 to meet oxygenation requirements. The controller 19 may use a sensor feedback loop. At a high level this includes collecting new sensor measurements, using the sensed measurements to determine the current state of the flow of gas in the device, comparing the current state to the desired values, and adjusting the system outputs to achieve the desired value.
[0220] The controller 19 could take input from many sensors as feedback in the humidity transition process. These inputs could include: humidity, ambient temperature, pressure, temperature of the air at the humidifier inlet, temperature of the gas at the humidifier outlet, temperature of the heater plate, power supplied to the heater plate, flow rate and inlet dew point. Measurements from the sensors may be used to controlthe humidifier (e.g. the heater plate and / or heater) to adjust the humidification level. The device may be controlled to dew point, absolute or relative humidity.
[0221] An input / output interface 54 (such as a display and / orinput device) is provided ("user interface"). The input device is for receiving information from a user (e.g., clinician or patient) that can be used for example for determining oxygenation requirements, anaesthetic gas agent, detection, flow rates, gas fractions, partial pressures and / or any other parameter that might be controlled by the apparatus 10. In some cases the user interface 54, or other I / O may be used to determine and / or control the humidification transition.
[0222] The apparatus 10 also comprises a display 45 which can be part of the user interface (I / O 54) for displaying the measure of the gas parameter of the exhaled gas flow, as a graph, digital readout or any other suitable means. It could display any sensor information and / or operating parameters, such as for example humidity, temperature, flow rate, pressure, oxygen fraction, SpO2 or the like.
[0223] As shown in Figure 16, the respiratory apparatus 10 may have a communications interface 15 to enable the controller 19 to receive signals from the sensors and / or to control the various components of the breathing assistance apparatus 10, including but not limited to the flow generator 50B, humidifier 52, heater, humidifier heater 59, or accessories or peripherals associated with the respiratory apparatus 10. Additionally, or alternatively, the communications interface 15 may deliver data to a remote server 16 or enable remote control of the respiratory apparatus 10 or respiratory therapy system. The communications interface 15, which may be referred to as a transceiver, can transmit various information e.g. usage information, amount of times comfort mode was initiated, parameters of comfort mode (e.g. time period for ramp, being a ramp rate) and operational mode parameters e.g. humidity, temperature, flow rate, etc. The communications interface may be used to transmit current and / or prior operating parameters to or from the respiratory apparatus.
[0224] The communications interface 15 may comprise a transmitter, receiver and / or transceiver. It could e.g. be a modem, WIFI™ transceiver, BLUETOOTH™ transceiver or any other suitable transceiver or transmitter or receiver. The communications interface15 may act as a network interface (for example, as a modem). The modem may be cellular. The communications interface 15 may communicate with a remote computing device such as a server 16. In some cases the apparatus 10 may communicate with a personal electronic device 17 which communicates with the server 16. For example a mobile phone application may pass data between the apparatus 10 and the server 16. The server 16 may be configured to operate a therapy management system. The server 16 may be configured to perform one or more of the following: receiving data, processing data and sending data. The data may be therapy data. Therapy data may comprise apparatus usage data, humidification parameters, environmental parameters, therapy settings. Raw data may be sent from the apparatus 10 to the remote computing device for processing, or processing may be shared between the devices. For example adherence data (e.g. session time records, or interface removal events) may be recorded at the server 16. The server 16 may allow a clinician to access this data or may forward the data to a clinician. The clinician may be prompted by the server 16 to adjust a humidification transition, or to confirm a change in humidification transition. Data transmission to the server 16 may occur at regular intervals (i.e., daily) or based on events (i.e. after a or each session).
[0225] In some cases the respiratory apparatus 10 comprises or is in the form of a high flow therapy apparatus. When configured to provide high flow therapy, the one or more operating parameters for high flow therapy may comprise any combination of: a therapy flow rate of the gases provided to the user, a therapy humidification level (for example a relative or absolute humidity, or a dew point) a therapy concentration of an auxiliary gas (e.g. 02) provided to the user, and a therapy temperature of the gases provided to the user (for example).
[0226] The respiratory apparatus 10 may also provide Bilevel / N IV respiratory therapy. Bilevel therapy may comprise providing gases to a user at a therapy IPAP and EPAP (and optionally one or more operating parameters as described in more detail below.). The respiratory apparatus 10 may also provide CPAP therapy. CPAP therapy may comprise providing gases to a user at a constant pressure. The respiratory apparatus 10 may comprise or be in the form of a humidification respiratory apparatus that provides humidification therapy.
[0227] In some configurations, the apparatus 10 may comprise at least one battery as part of a battery module 125 (with optional battery cover 126). The battery module 125 may be located in the housing 1 1 of the apparatus 10, and / or attached externally to the housing 1 1 of the apparatus. It will be appreciated when the term battery is used in the specification it may refer to either the battery itself, or the battery module 125 which comprises the battery. The battery can supply power when mains is unavailable (as a battery supply). For example, this might allow the patient to move around with the apparatus 10 and still get therapy and / or the comfort mode. In some configurations, the battery may be removably coupled to the apparatus and is rechargeable.
[0228] In some configurations, the battery is removable and optionally connectable and disconnectable from the apparatus 10. Alternatively, the battery or battery module 125 is non-removable. In some configurations, the battery module 125 is provided as part of the same housing as the flow generator and / or the humidifier. In some configurations, the battery module 125 or battery is provided as connectable and disconnectable to the same housing as the flow generator and / or the humidifier. Having the battery as part of the housing, or connectable and disconnectable to the housing may allow for the apparatus to be portable compared to other apparatuses (for example larger apparatuses such as ventilators, orthose with external battery power sources which are not portable). Portability of the apparatus may increase usability of the apparatus in a homecare setting as the apparatus can be more easily moved around the user's house. In a hospital setting portability allows the therapy apparatus to be moved around the hospital with the patient so the patient can continue to receive therapy while being transported.
[0229] The respiratory apparatus 10 of Figure 1 in any of its forms can be configured to provide humidity acclimatisation by modifying one or more humidification parameters. The controller 19 of the apparatus 10 to operate the apparatus as described. The respiratory apparatus 10 is configured to, over multiple sessions and optionally also within sessions, increase patient comfort. This can be through acclimatising the patient to operational levels of humidity by controlling the temperature of the gas flow overtime so the patient feels comfort and therefore is more likely to be compliant. The rate ofhumidity change is configured to be slow enough / or the humidity is changed over enough sessions to allow the patient to become comfortable with the humidification level.
[0230] The description refers to humidity primarily, as well as temperature. It should be reiterated that humidity and temperature are operating parameters, and reducing or increasing humidity and temperature means reducing or increasing an operating parameter level. An operating parameter can take many levels (values), including an initial level (which may reflect a comfort level for the patient), an operational level (such as a desired therapeutic level) or any level in between. Humidity can take many levels (values), including an initial level, an operational level or any level in between. The operational level is the operational humidification level (value e.g. degrees or dew point or percentage relative humidity) provided during or prescribed for usual operation / therapy. For example, operational level humidity value could be 37 degrees C dewpoint at 100%RH. Other dewpoint settings could be 31 degrees Celsius, 34 degrees Celsius.
[0231] In general terms, the respiratory apparatus 10 is configured to activate a multisession humidification transition which provides acclimatisation outcomes over multiple sessions of high flow therapy. More broadly the same approach can apply to any parameter transition, or combined transition of two or more parameters. Taking humidity as a non-limiting example: the apparatus alters the humidity of gas over time from an initial (e.g., comfort) humidification level to an operational humidification level to provide comfort to / acclimatise the patient. The initial humidification level is comfortable / tolerable to the patient. As the humidity is increased to the operational level (which may be a desired or therapeutic humidification level), the patient can acclimatise so that the humidification level of the flow of gases 31 is comfortable when they reach the operational level.
[0232] Some examples of initial humidification levels could be: a certain number of degrees below operational level dew point. For example, the initial comfort level dew point could be 3 degrees below operational dew point level, e.g. comfort level is 34 degrees dew point when the operational level is 37 degrees dew point. Any suitable drop from operating level dew point is possible. The skilled person would understand that theinitial, comfort, desired and therapeutic parameters and movement between them could be applied to any parameter including temperature, flow, supplementary oxygen and pressure as required.
[0233] The respiratory apparatus 10 may control the humidification level by modifying one or more humidification parameters. The controller 19 may control any one or more of the heater plate 59 and / or heater wire 58 to control gas flow 31 humidity ortemperature. The control steps may comprise controlling the heater plate 59 to control the humidity of the gas flow 31 ; the heater wire 58 so that the humidity of the gas flow 31 ; both the heater plate and the wire; and flow generator 50B and / or other components of the humidifier 52 or respiratory apparatus 10. Controlling the heater plate 59 and / or heater wire 58 may comprise controlling power to the heater plate 59 and / or heater wire 58 as required. This can be done in various ways. This could be by way of controlling voltage and / or current to the heater plate 59 / heater wire 58, such as by controlling duty cycle, voltage / current magnitude and / or any other suitable method.
[0234] The control of the humidification level may be implemented in various ways, with some non-limiting examples being: modifying closed loop control of humidity and / or temperature at the water chamber outlet, modifying set point temperature and / or humidity at the chamber outlet and / or patient end, open loop control of power provided to the heater plate and / or heater wire, and closed or open loop of some other parameter that indirectly controls temperature and / or humidity at the water chamber outlet and / or patient end of the conduit 55.
[0235] The heater plate 59 is typically the largest contributor to the humidity of the gas flow 31. Typically, in humidity control of a gas flow 31, the heater plate 59 temperature determines the rate of evaporation of the water in the humidification chamber 52 and thus is a driver of humidity in the gas flow 31. It also contributes to the gas flow temperature. The heater wire 58 controls gas flow 31 temperature in conduit 55 (which may be referred to as a breathing tube) to keep the gas flow at a temperature a few degrees above the estimated dew point to prevent condensation forming. Generally, the conduit 55 temperature is the main contributor to the temperature of the gas to the patient (i.e., at or near the patient interface 51).
[0236] The controller 19 controls the respiratory apparatus 10 to alter the humidity and / or temperature parameter(s) as required to achieve the parameter transition. For example, the heater plate 59 could be controlled to control humidity and / ortemperature from an initial level then raise it to an operational level. Alternatively, or in addition, the heater wire 58 may be controlled to control humidity and / or temperature from an initial level then raise it to an operational level (including any parameter initial period).
[0237] In one example, once the respiratory apparatus 10 implements a change in parameter, such as a humidification transition (insofar that the humidity and / or temperature parameters of the respiratory apparatus 10 are not at an initial level) one or more of the humidity and / or temperature parameters are modified to an initial level. This level is configured to be a comfort level where the humidity and / or temperature is at a level that the patient can tolerate). In other cases, the initial level may be configured based on the operating level. For example, a predefined level below the operating level, or a percentage reduction from the operating level.
[0238] The humidification and / or temperature parameters can be controlled, for example at an initial humidification level or between the initial and a desired humidification level, by operating the heater plate 59 and / or heated conduit 55 to reduce the gas flow temperature and / or gas flow humidity. For example, to decrease the humidification parameters to the initial level one or more of the following example actions can be implemented: the heater plate power is reduced to reduce gas flow humidity at the water outlet and / or the patient interface; the heater plate power is reduced to reduce gas flow temperature at the water chamber outlet and / or the patient interface; the heater plate power and / or heater wire power is reduced to reduce the gas flow temperature at the patient; the humidity is reduced but as a result temperature rises, so the temperature is reduced by reducing the heater plate and / or heater wire power; the heater wire is controlled to change the relative humidity; the heater plate and heater wire can be controlled to reduce dew point.
[0239] Humidification and / ortemperature parameters may be increased by operating the heater plate 59 and / or heated conduit 55 to increase the gas flow humidity. For example, to increase the humidity from the initial level to the operational level, one ormore of the following actions can be implemented: the power provided to the heater plate is increased over a time period to increase gas flow humidity at the water outlet and / or the patient interface to operational level; the power provided to the heater plate is increased over a time period to increase gas flow temperature at the water chamber outlet and / or the patient interface to operational level; the power provided to the heater plate power and / or heater wire is increased over a time period to reduce the gas flow temperature at the patient; the heater wire is controlled to change the relative humidity; The heater plate and heater wire can be controlled to reduce dew point.
[0240] The example actions for controlling the heater plate and heater wire to the initial humidification level and back to the operational humidification level are not exhaustive. Further, multiple actions can be used in combination to effect comfort. In some cases different actions are used to decrease and increase humidification parameters, even where the same operational level is returned to. In some cases the apparatus is able to implement one or a plurality of actions based on a single control. For example, the humidification set point may be specified and the apparatus 10 may take one or more actions to maintain or to reach the humidification set point. In some cases, for example where closed loop control is used by the respiratory apparatus 10 to control humidity to a set point (that is desired humidity), the action can be revising the set point.
[0241] As an example, the gas flow humidity might be an initial humidification level, and then increased to an operational level over multiple sessions. That is, the humidity can be ramped or modified to the operational level over multiple sessions. In some cases to achieve this, the power to the heater plate is modified in each session or between sessions to modify the heater plate temperature (which ramps humidity of the gas flow). The controller 19 may control the heater plate power to modify according to a profile over each of or the combined sessions. The number of sessions and / or the profile in each session may be specified. The number of sessions will, at least in part, define the rate of change of the humidity. A greater number of sessions allows for a slower humidity rate of increase and more time for patient comfort.
[0242] There are many ways to control the heater plate 59 and / or heater wire 58, typically by controlling power to the heater plate / heater wire, via voltage and / or current control. In one typical, but not limiting, operation of a respiratory apparatus 10, the heater plate 59 is controlled by a PID controller (Proportional-lntegral-Derivative Controller), wherein the increase from ambient temperature to the temperature needed to achieve the required dewpoint is as fast and accurate as possible. Implementing a humidity ramp using a PID control could be achieved by several methods.
[0243] In a first method, a PID controller with different parameters is used to ramp the humidity towards the operational level. If the PID settings used in normal device operation are tuned to resemble ideal control (minimal rise-time, minimal overshoot, no steady-state error), then PID settings applied when the humidity is ramping would be tuned differently so the rise time is a longer period (that could be set by the patient). This could be achieved by reducing the proportional and integral gain constants.
[0244] Another method is to control the voltage or current supplied to the heater plate between the initial level and the operational level. The controller 59 determines the power to be supplied to achieve the desired temperature of the heater plate 59 and consequent dew point (operational level of humidity) of the gas. The rate of heater plate temperature increase can be slowed by scaling the outputs of the PID controller or capping the maximum power so that the system retains the favorable steady state conditions present with optimal PID tuning while having a longer time to reach the desired temperature.
[0245] In another method the voltage or current may be modified upward or the voltage or current set point may be ramped up slowly. In a further alternative the duty cycle applied will be increased at a set rate. The heater plate 59 is powered by duty cycle control. The duty cycle may be reduced to achieve the lower temperature and then the duty cycle target is ramped to achieve the humidity / temp ramp. Alternatively, the difference between the desired dew point and the lower starting point at the beginning of the humidification transition could be fed into the control system as many incremental increases in the desired dew point, rather than a single change. The size of each increment and the delay between consecutive increments would allow the totalhumidification transition to be predictably set. Using this method, the existing optimal PID tuning can be used at each increase in set point up to the desired dew point. In some cases, the set point might not be gradually increased, but rather set at the operational level, and then another control method used to increase power to the heater plate 59 and / or heater wire 58 in order to increase the humidification parameters to the operational level (e.g. by changing the duty cycle).
[0246] In another method, the respiratory apparatus 10 is operated to modify humidity of the gas flow to gradually acclimatise a patient to their prescribed therapy settings. It does this by controlling the heater plate 59 through slow modification of humidity settings from a lower setpoint up to the operational settings over multiple sessions. In some examples the multi-session humidification transition could be initiated when the patient is experiencing discomfort or based on clinician instructions or apparatus settings.
[0247] When implementing actions, the controller 19 can use one or more sensor 53A-53E, 14 inputs to obtain the required information. The controller 19 can use the same sensor feedback loop as in normal operating modes. At a high level this includes collecting new sensor measurements, using the sensed metrics to determine the current state of the gas in the device, comparing the current state to the desired values, and adjusting the system outputs to achieve the desired value.
[0248] The controller 19 could take input from many sensors 53A-53E, 14 as feedback in the humidification transition. These could include any one or more of: Humidity; Ambient temperature; Pressure; Temperature of the air at the humidifier inlet; Temperature of the gas at the humidifier outlet; Temperature of the heater plate; Power supplied to the heater plate; Flow rate; and Inlet dew point. These sensors could take readings at any suitable point, such as any one or more of: the humidifier inlet; in the humidifier; the humidifier outlet; the breathing conduit inlet; in the breathing conduit; the breathing conduit outlet; a patient interface inlet; in the patient interface; and a patient interface outlet.
[0249] Multi-session humidification transitions are applied over a plurality of sessions. They optionally have defined transitions within each session. The number of sessions caninfluence the time profile of the varying of a humidification parameter. The number of sessions can be determined in a suitable mannerto achieve acclimatisation of the patient to the operational level of humidification parameter. Optionally the plurality of sessions comprises one or more maintenance sessions where the apparatus maintains a comfort humidification level, before ramping to the operational level in the remaining sessions. Optionally each session comprises a initial period where the apparatus maintains a comfort humidification level before ramping the desired session humidification level.
[0250] In some cases the user (e.g. patient or clinician) may set the number of sessions. This may be set manually. There might be a plurality of options for number of sessions that a patient can select from. For example, there could be a 7, 14 and 21 session increases. These session numbers may be predefined and stored in the memory of the flow generator.
[0251] In some cases the user may set a total time for the humidity transition. This total time would span several sessions. The profile of the humidity transition may be, for example, a continuous increase, or discrete increases. The increases may occur at different points of the session depending on the overall elapsed time. As the total time is independent of individual sessions (unless the patient is very consistent) this means that the discrete increases may occur within the sessions. For example the humidification level may be incremented every four hours of use. In some cases each operating session may start from the end point of the last operating session.
[0252] The preferences of the patient / user may be stored in the memory of the respiratory apparatus 10, or on a remote server and communicated to the apparatus. The preferences may be associated with a patient. The group of preferences associated with a patient may form at least a part of a patient profile. The patient profile may further comprise one or more of: disease conditions; therapy parameters such as flow rate, pressure or humidity parameters. The patient profile may be loaded into the apparatus 10 to allow device to automatically operate the humidity transition. The patient profile may alternatively or additionally be stored at a remote server 16 as described above. The patient profile may be retrieved from the remote server 16 by the respiratory apparatus. The patient may be able to specify and store one or more operating parameters, such asa number of sessions / ramp rate for humidity. The operating parameters might be predefined. The respiratory apparatus could review these prior operating parameters when beginning operation and consider the operating parameters for a present session. The prior operating parameters may represent one or more prior operating sessions.
[0253] Comfort, including acclimatisation, is particularly useful for a homecare patient that could be using respiratory apparatus 10 for a long time and / or without assistance. A homecare patient uses the respiratory apparatus 10 in a home environment, as opposed to (or in conjunction with) a hospital or medical facility. The homecare patient may also be in an assisted living home, such as a palliative care facility, hospice or nursing home.
[0254] The multi-session humidification transition method may be applied to other respiratory apparatus 10 or systems. Figure 1 shows a heated pass-over humidifier. A heated pass-over humidifier typically contains a volume of water that reduces as water is evaporated. The entirety of the water reserve is heated to achieve humidification of the patient-bound airstream. In some cases a heated pass-over humidifier comprises a float. The float in the water chamber 52. The float operates a valve to release water (or other liquid(s) used in the water chamber 52) from a water reservoir into the chamber 52 when the water level drops below a threshold. This may be configured such that a substantially constant water level is maintained and / or so that the water level in the chamber is maintained above a threshold level.
[0255] A further humidification system is a vaporization humidifier. For example, W02016036260A1 , incorporated herein by reference, introduces a deterministically controlled humidification system (also referred to as a vaporization humidifier). A vaporization humidifier typically applied a portion of water (or suitable liquid) onto a heating surface. The portion of water may be controlled or dosed. Depositing the water on the heating surface causes it to be vaporized into a gases flow. The humidified gases flow can then be provided to the patient. Vaporization humidifiers may be controlled in a deterministic manner wherein the portion comprises a determined quantity of liquid. The determined quantity of liquid configured to achieve the desired humidity. In some cases a controller is configured to determine, or look-up, the quantity of liquid required.In a vaporization humidifier water flow may be controlled to achieve a desired humidity, whereas, in a float humidifier water flow is controlled to maintain a volume of water in the chamber.
[0256] Figure 2 shows an example respiratory apparatus 10 comprising a vaporisation humidifier form of a respiratory humidification system 101. The respiratory humidification system 101 includes a conduit 55 (which may also be referred to herein as "a gases channel", "a breathing tube," or "an inspiratory tube") adapted to receive gases from the flow generator (not shown) and / or another gases source and channel the gases to an outlet, such as a patient interface 51. In use, gases typically flow from the flow generator to the respiratory humidification system 101 (for example, through the conduit 55), and from the respiratory humidification system 101 to the outlet or patient interface 51 (for example, through the conduit 55) in a downstream direction.
[0257] As shown in Figure 2 a non-limiting exemplary configuration respiratory humidification system 101 includes a fluid reservoir or water chamber 57 which in use houses a fluid 104. "Fluid" in this context may refer to liquids or fluent solids suitable for humidifying respiratory gases and may include, for example, water. The fluid 104 may be a water with additives that are more volatile than water. The water chamber 57 is fluidly or otherwise physically linked to a meter or metering arrangement (also referred to as a liquid flow controller or water flow controller herein) 1 10. The metering arrangement 110 is configured to meter fluid from the fluid reservoir 106 to a heater plate 114, or other system configured to provide a heating surface. The metering arrangement 1 10 can further include a pump. The pump can be a positive displacement pump, such as, for example, a piezoelectric diaphragm pump, a peristaltic pump, a micro-pump, or a progressive cavity pump. The pump can also be a pressure feed, such as a gravity feed in series with a control valve. The metering arrangement 1 10 can include a wicking structure that employs capillary action to controllably meter the water to the wicking element and / or to the heating surface.
[0258] The respiratory apparatus 10 (which may be or comprise a the respiratory humidification system 101) can include a controller 118 that can control the operation of components of the respiratory apparatus 10 or of the respiratory humidification system101 , including but not limited to the flow generator, the metering arrangement 1 10, and / or the heater plate 1 14. he first and second fluid conduits 108, 1 12 may be configured to communicate fluids to various components of the respiratory humidification system 101. As illustrated in Figure 2, a first fluid conduit 108 may be configured to fluidly communicate fluid from the fluid reservoir 57 to the metering arrangement 1 10, and the second fluid conduit 1 12 may be configured to fluidly communicate fluid from the metering arrangement 1 10 to the humidification housing conduit 55 or humidification housing. The second fluid conduit may have an outlet 1 16 configured to direct the liquid onto the heater plate 1 14. It will be understood that different arrangements are possible, where the system still allows the vaporisation of a controlled amount of liquid.
[0259] Metering arrangement 110 can be controlled by a water flow controller 118 (water flow controller may form, or be combined with, controller 19 and / or a humidifier controller). The metering arrangement 1 10 may comprise a pump in an open-loop configuration. The metering arrangement 1 10 may comprise a pump or a flow actuator in series with a flow sensor in a closed-loop configuration. In other configurations, a pump or a flow actuator in series with a flow sensor in a closed-loop configuration can be used. The water flow controller may configure the metering arrangement to provide a continuous flow of water in the range of 0 mL / min to approximately 10 mL / min. The metering system 1 10, may be configured to ensure that the surface of the heater plate 1 14 is entirely wetted (saturated). A fully wetted surface may allow for improved deterministic control of the humidity. A wetted surface also means that humidity can be increased more quickly as water travels more quickly over a wet surface than it does over a dry surface.
[0260] The heater plate 114 can have a wicking element configured to distribute the metered fluid to the heater plate 1 14. In some configurations, the wicking element is configured to wick the metered fluid evenly across the surface of the heater plate 1 14. The heater plate 114 may be configured to vaporize the metered fluid such that it becomes entrained in the gases flow in use by the respiratory therapy apparatus 10. The heater plate 1 14 can be configured to be maintain a heating surface at a temperaturerange. The temperature range may be between approximately 30 °C and approximately 99.9 °C.
[0261] The metering arrangement 1 10 may be configured to meter or allocate fluid to the humidifier and / or to the heater plate 1 14 at metering rates that raise the moisture content of gases passing through the conduit 55 such that the gases reach a predefined, calculated, or estimated humidification level representing a level of gases humidification needed or desired by a patient while taking care to reduce or eliminate the likelihood of undue moisture accumulation in the gases channel 102. To control the humidification, in one example, the controller 1 18 can control the metering rate of the metering arrangement 110 based on any one or more of: a measured flow rate of gases passing through the conduit 55; a measured moisture value corresponding to the humidity of gases upstream of the humidification housing; a measured pressure level corresponding to the pressure level in the gases channel 102, or a combination thereof.
[0262] The controller 118 can control the metering rate of the metering arrangement 1 10 based on a combination of one or more of measured inputs such as: measure flow rate of gases passing through the conduit 55; a measured moisture value corresponding to the humidity of gases upstream of the humidification housing; a measured flow rate of gases passing through the conduit 55; and a measured pressure level corresponding to the pressure level in the conduit 55.
[0263] The respiratory apparatus 10, implemented as a respiratory humidification system 101 , may include deterministic or open loop control with various control systems possible. In general, deterministic control may allow for on-demand humidification achieved by controlling certain input variables, for example, by controlling water flow to the heating surface. In some configurations, control of the water flow rate to the heating surface may be based on one or more on parameters of the gases flow, water evaporation, temperature sensors, pressures, humidities, power levels, effective heating areas or velocities. As shown and described in reference to Figure 2, the respiratory therapy apparatus 10 and / or the components thereof (for example the respiratory humidification system 101 ) may include a number of sensors to measure these variables.
[0264] A respiratory humidification system 101 may have various control systems and configurations to provide the described humidification. For example the controller 1 18 may comprise a humidification fluid flow control sub-system that monitors and controls the rate at which fluid is metered to the humidification region and, more specifically, to the heater plate 1 14. A fluid flow sensor measures the flow of the humidification fluid and provides the measurement to a fluid flow controller. The controller compares the measured fluid flow rate with the desired fluid flow rate (which may be predefined, estimated, or deterministically derived), and adjusts the power level to the metering arrangement accordingly.
[0265] In some cases a preheater may be used before the gas flow is provided to the heater plate 114. The inlet and pre-heating control sub-system may measure the air and / or gas coming into the humidifier using inlet sensors to determine the ambient humidity of the incoming gas flow rate and the incoming gas pressure. The gas flow may then be heated with a pre-heater. An inlet temperature sensor downstream of the preheater can then measure the temperature of the heated gas, which can be compared with a calculated temperature set or defined by the controller, with signals sent to the pre-heater to adjust the temperature accordingly.
[0266] In some cases a water flow control subsystem may be used. In one example water 104 enters a water pump from a water source 57. The water pump may pump the water into the respiratory apparatus 10. A water flow sensor is positioned downstream from the pump and measures the flow rate of the water which is output to a liquid flow controller. The liquid flow controller provides a feedback loop whereby the water pump is adjusted based on a comparison of and a calculated water flow rate. The calculated water flow rate is determined by the overall system controller.
[0267] In some cases a heated surface control subsystem may be used. In some cases the heater plate 114 comprises multiple heater plates, or two heating zones are located on one heater plate. The heated surface controller acts when water flow and gas flow, are routed over the heater plate 1 14 or heating surface. The surface may include one or more surface temperature sensors which provide measurements of the surface temperature to a surface temperature controller. The surface temperature controllerprovides a feedback and control mechanism whereby heater plate 114, which either forms the surface or is in thermal communication with the surface, is adjusted. The surface temperature controller may compare the sensed temperature to a calculated surface temperature. The calculated surface temperature is determined by the overall system controller of the humidifier or system. The overall system controller of the humidifier or respiratory apparatus may receive input sensors, including ambient humidity, incoming gas flow rate, incoming gas pressure and a set humidity (such as a dew point temperature). Optionally the overall system may also receive power inputs, such as the power delivered to the surface, or power delivered to the air. These, or further inputs may be used to calculate the set temperatures or mass flow rates discussed above.
[0268] In some cases, a deterministic humidifier has the advantage that a relatively small amount of water contacts the heater plate 1 14 at a given time. Therefore, if a change in humidity generation is required, the thermal resistance of the water is low, so the heater plate can change temperature faster and thus reduce / increase humidity faster than a heated pass-over humidifier.
[0269] The multi-stage humidification transition, or session humidification transition may be used with a deterministic humidifier arrangement. In some cases, this is advantageous because the method can take advantage of the quicker changes in operational levels available to more closely control the humidification transition between humidification levels. Where the controller 1 18 knows, for example, the flow rate and humidity of the gas, it can calculate the amount of water vapor to add to achieve the comfort dew point and thus to reach the comfort target and return to the operational level.
[0270] In some cases, the use of a deterministic humidifier system encourages the control of water flow rate in addition to the heater plate power. In either case further parameters (for example, gases flow rate and / or pressure) may also be controlled. The use of a deterministic humidification system (or other suitable respiratory apparatus) may allow the rate of change between humidification levels to be increased or controlled more exactly. This is because the humidification process can be more precisely controlled using the metering apparatus 1 10. In some cases the time frame of the transitionbetween levels, can be controlled more precisely. For example, a transition may be controlled over a predefined period. In some cases the patient comfort can be monitored during a transition (e.g., by tracking the trigger of a further comfort response, or by monitoring patient interface removal) and the transition may be modified to increase comfort, for example by slowing the transition.
[0271] In some cases a humidification transition comprises the water flow rate being modified to a required level. In some cases the heater plate 1 14 power is reduced. The power may be reduced simultaneously with the water flow rate, or before or after the water flow rate. One or more of the control or comfort methods described above can be applied to different humidification systems, such as a deterministic humidifier. These alternative humidifiers may have additional operating parameters to be controlled, such as water flow rate.
[0272] The herein method may acclimatise the patient to a humidity from an initial comfort level to an operational level over a time period including multiple sessions. As the humidification level gradually increases over multiple sessions, the patient tolerates each increase (acclimatises to each level) so experiences comfort in each of the sessions. By the time the operational level is reached, the patient can tolerate that humidity, even if they could not have done so at the outset. Because the patient can tolerate the humidification level, they are more likely to use the respiratory apparatus as directed and more likely to be compliant with the therapy provided by the respiratory apparatus.
[0273] In an example use a clinician specifies a humidification level of 37degreesC dew point. However, the patient only has a comfort level of 34degreesC (which may be determined by the controller). The controller determines a multi-session humidity transition over seven sessions, starting at 34 degrees and finishing at 37 degrees. In each session the humidification level is constant, but a fixed increment (0.5C) is applied between sessions. In the third session the patient pushes a button to indicate discomfort. The session humidification transition changes. The humidity is reduced by 0.3C to 34.7C for the next 10 minutes of the session. A ramp is then applied to return the humidification level to 35 C. If the patient indicates further discomfort the humidification level may be reduced again, optionally by a smaller amount, to 34.85C. If the patient removes thepatient interface during the session the session may pause the transition (i.e. not count the removed time as part of the session). The transition will resume when the patient interface is worn again. If the patient does not return to the session the session is incomplete. The controller may determine that future sessions should be modified to improve comfort, that the session should be repeated, or session four should continue as normal.
[0274] Figure 3 shows a multi-session humidification transition between an initial humidification level 200 and a desired humidification level 201. A specific transition profile is not shown, simply the end points 200, 201 and the division of the overall time period of the transition into six sessions 202. Each session 202 may have a set humidification level, or humidification profile. The use of multiple sessions 202 allows the humidity to be increased to the therapeutic level over a longer time period than a single session could provide. This may be advantageous in an acclimatisation to higher humidities at the start of treatment, in contrast to intra-session humidity transitions which provide a temporary break from a therapeutic level of humidity or a brief ramp.
[0275] Figure 4 multi-session shows a humidification transition between an initial humidification level 200 and a desired humidification level 201. Again six sessions 202 are shown. The session humidification transitions 204 are shown in each session. The session humidification transitions 204 break the multi-session humidification transition into a plurality of parts. Each part shows a transition from an initial session humidification level 230 to a desired session humidification level 240. Figure 4 shows each of the session humidification transitions 204 starting at an initial session humidification level 230 which is equal to the desired session humidification level 240 of the prior session. However, this is not necessary. In some cases the initial session humidification level 230 is lower than the prior desired session humidification level 240 to ensure the initial session humidification level 230 is at a comfort level. In some cases each session 202 is at a constant level, with the increments made between sessions (i.e. between a desired session humidification level 240 of the prior session and an initial session humidification level 230 of the current session).
[0276] Although shown as only initial and desired session humidification levels the multi-session humidification transition 250 may have an overall profile, broken into profiles for each session, or session specific profiles for each session between the initial and desired session humidification levels 230, 240. Figure 5 shows the multi-session humidification transition 250. The multi-session humidification transition moves from the initial humidification level 200 to the desired humidification level 201 over the six sessions shown. The multi-session humidification transition 250 also passes through each of the session initial humidification levels 230 and desired session humidification level 240, creating session humidification transitions 204 between each. Although shown as a continuous function the multi-session humidification transition 250 may have breaks (e.g. initial and final periods), for example at the beginning or end of sessions, or between sessions to offset neighbouring end and start humidification levels.
[0277] Figure 6 shows an alternative multi-session humidification transition between an initial humidification level 200 and a desired humidification level 201, which may be an operation humidification level. In this example the humidity profile in each session 202 is constant while an increment 260 is added to the humidification level between sessions 202. This may allow a patient to adjust to a comfortable level of humidity in each session 202 making the increment 260 at the start of the next session feel comfortable. The constant humidity in each session 202 may reduce a feeling of constant adjustment for a patient. In some cases there may be a larger increment 260 between sessions 202 but also a small increment within the session 202. In some cases constant sessions may be intermingled with increasing sessions.
[0278] As shown in Figure 6 the multi-session humidification transition can be applied as a series of increases in humidity (increments 260) across the therapy sessions. The number of therapy sessions 202 can be adjusted to control the rate of increase in humidity. In some cases a constant humidification level is applied in each session 202 and the next session 202 uses an increase in humidity irrespective of session length. The increment 260 between each session 202 could be fixed or variable. Where the increment 260 is fixed and therefore the period (number of sessions 202) of the multi-session humidification transition determined by the increment 260 and the difference betweendesired and initial humidification levels. Alternatively, the period for the humidification transition could be used to determine the rate of change between session to ensure the humidification transition is complete. When the humidity increment (R) is set, period (P) of the ramp can be calculated:
[0279] Alternatively when period (P) is set, the humidity increment (R) of the ramp can be calculated:
[0280] Figure 18 shows an alternative multi-session humidification transition in which the elapsed time is used instead of the number of sessions. Five sessions 202 are shown with gaps between them. However, the transition from the initial humidification level 200 and a desired humidification level 201 does not depend on the start or end of the sessions 202. Instead increments are shown occurring at time-based intervals. The intervals may be evenly spaced. The size of the increments may be constant, or the size may be variable. For example, the size of the increments may reduce at higher humidity levels, or as the humidification level approached the operational humidification level. In some cases an initial period may be added at the start of each session before the time based humidification level is applied. In some cases a final period may be added at the end of each session after the time-based humidification level is applied, These periods may provide comfort at the beginning or end of sessions. In some cases a session may be considered to begin after the initial period, or end before the final period.
[0281] Figure 19 shows a multi-session humidification transition in which the patient is receiving multiple types of treatment. In this example, the humidification transition of a NHF therapy is shown in black sessions 202. Between each NHF therapy session 202 pressure therapy sessions 203 (shown in grey) are delivered. In this example there is no ramp in pressure therapy sessions 203. In Figure 19 the pressure therapy session 203 humidification level is shown as lower than initial humidification level 200. However, the pressure therapy session humidification level may be any level relative to the humidification level provided in the NHF therapy sessions. Typically the pressure therapy session humidification level wil Ibe lower than the desired humidification level 201).
[0282] Figure 20 shows an example in which both therapies have humidification ramps. The NHF therapy again ramps from the initial humidification level 200 to a desired humidification level 201 . The pressure therapy ramps from an initial humidification level to a desired pressure therapy humidification level 210. The initial humidification level of the pressure therapy may be the same or may be different from the NHF therapy initial humidification level 200. The desired humidification levels 201 , 210 may also be the same or different. In both cases of Figure 20 a constant increment is shown between sessions with each session 202, 203 at a constant humidification level. However, the other variations discussed could be used. In some cases, the transition in one therapy could be adjusted based on the comfort achieved in the other therapy. For example a humidification level in one therapy could be mapped by a fixed offset or any other functional relationship. Examples include a look-up table or a non-linear formula. Although alternative sessions are shown this is not required, there may be a plurality of sessions of one type of therapy between sessions of the other type of therapy. In some cases, more than two therapies are applied.
[0283] Figure 21 shows a multi-session humidification transition in which different session types have different transitions. Alternating day 235 and night 245 sessions are shown. As shown sessions 1 , 3, 5 and 7 are day sessions. While the overall humidification transitions is still between an initial humidification level 200 and a desired humidification level 201 no increment occurs in night sessions while a constant rate of increase is shown in day sessions 3, 5 and 7. In another example increments only occur in one of days sessions or night sessions. This may improve adherence during the sessions without increments. Alternative variations are possible between types of sessions. For example, there may be a smaller increment, or rate of increase, in day sessions than in night sessions. In a further example the desired humidification level may be lower during day sessions than night sessions, or vice versa. Humidity may be less tolerable during the day (for example due to being busy with activities) so that no, or lower, humidity increases are set. The differences in humidity may depend on a patient's therapy. In an alternative case the humidity target may be increased because higher activity levels may lead to higher demand for mucus clearance. During a night session higher humidity levels may be less tolerable during sleep or water needs to be conserved. In some cases prior sessioninformation may be specified or applied differently for day and night sessions. Although described as night and day sessions other types of sessions may be similarly distinguished.
[0284] Figure 7 shows an example session humidification transition 204 in detail. Across a session 202 of 650 minutes the session humidity increases by an increment 260. The increment 260 provides an increase from an initial session humidification level 230 to a desired session humidification level 240. However, the session humidification transition 204 is not constant, or at a constant rate. Instead the session humidification transition 204 has an initial ramp period 244 followed by a plateau of fixed humidity region 245. This example transition may provide a period of operational level humidity before the end of the session 202 to enable a patient to become comfortable at that humidification level. In some cases the length of a therapy session is variable.
[0285] By having the increment 260 occur in a first period of time, the increment can be completed in a set period to ensure it is completed within a session 202. For example the transition 204 may be configured to occur within an hour, 2 hours, 3 hours, 4 hours, 5 hours or 6 hours, or within the patient's average session 202 length based on historical data. The change in humidity from the initial comfort level to the operational level could be evenly split between the multiple sessions. The change in humidity from the initial level 200 to the operational level 201 could be variably split between the multiple sessions 202. The profile shown in Figure 7 is merely an example any suitable transition could be used. These may include rises and falls in humidity, plateaus and / or curves.
[0286] If a session is ended before the completion of a transition (l.e. during ramp 244) the following session may be modified. In some cases an alert or record of the end of the session is stored for the following session. The following session may repeat the incomplete session, or the following session may begin at the humidification level at the end of the incomplete session. These changes, or other modifications, will affect the multi-session humidification transition. Additional sessions may be added in response, or the size of later increments be adjusted, or the rate of increase of later sessions increased, or a combination of these response. Other responses could be used to maintain the intended number of sessions. Alternatively, the next session may continueas normal and the incomplete session be ignored. This may change if the next session is also incomplete.
[0287] Figure 8 shows an example session humidification transition 204 in detail. Across a session 202 of 650 minutes the session humidity increases by an increment 260. The increment 260 provides an increase from an initial session humidification level 230 to a desired session humidification level 240. However, the session humidification transition 204 is not constant, or at a constant rate. Instead the session humidification transition 204 increases at a reducing rate of increase. This produces the curve shown in Figure 8. This may allow the apparatus to quickly increase the humidification level at lower humidities while increasing more slowly at higher humidities where the patient may be more likely to experience discomfort. Again, a plateau (e.g. a period of constant humidity) could be added at the end of the transition to ensure a period at the desired session humidification level 240. The profile shown in Figure 8 is merely an example any suitable transition could be used. These may include rises and falls in humidity, plateaus and / or curves.
[0288] The example transitions of Figures 7 and 8 are for session humidification transitions 204. The multi-session humidification transition 250 could be a combination of two or more of these, or other, session humidification transitions 204. The multisession humidification transition 250 could form a piecewise function. The multi-session humidification transition 250 could have different start and end values. The multi-session humidification transition 250 could form a continuous function or curve, with sections of the function or curve forming each humidity session transition 202. A multi-session humidification transition 250 from an initial humidification level 200 to an operational or therapeutic therapy level 201 may comprise a plurality of the same of different types of session humidification transitions 202. Each session humidification transition 202 may be a ramp or a curve, or there may be a variety of ramps, pauses and curves. The session humidification transitions 202 may depend on the adherence, or the apparent acclimatisation a patient in one or more prior operating sessions.
[0289] In some cases a user input 210 is used by the respiratory apparatus 10. The user input could be used to indicate a level of discomfort for the patient. Figure 9 showsthat, within a session 202 the session humidification transition 204 may be altered if one or more user inputs 210 are received. For example the intended session humidification transition 202 may have been a rapid curve from the initial session humidity 230 to the desired session humidity 240. However, after the humidity has plateaued at the desired session humidification level 240 a first user input 210 is received. To comfort the patient the humidity is reduced 21 1 . The reduction 21 1 may be to a comfort humidification level 273. This is shown as a humidity between the desired and initial session humidities. However the comfort humidification level 273 may be the same or below the initial session humidification level 230. The reduction in humidity may be a fixed humidity drop or may be relative to the session humidification levels 230, 240.
[0290] After the reduction 21 1 in humidity the humidity may be kept at the comfort humidification level 273. However, to continue to acclimatise the patient the humidity may be increased 212 again. The rate of increase may be the same as previously. However, as shown in Figure 9 the rate of increase may be reduced. Reducing the rate of humidity increase may help to reduce the previous discomfort of the patient. The rate may be reduced to a suitable amount, either a fixed reduction or relative to the humidification levels or the previous rate of reduction. In one example the rate of increase is reduced to or towards the minimum required to reach the desired humidification level 240 in the remaining session time. Figure 9 shows the rate of increase being reduced so that it is unlikely to achieve the desired session humidification level. In some cases the multi-session humidification transition is adjusted so as to account for this change in the session humidification transition. This adjustment may require increasing the number of sessions 202 or attempting to increase the rate of humidity increase or the size of the increment of later sessions.
[0291] In some cases the apparatus 10 may receive multiple user inputs 210 showing discomfort. A second or later user input 210 may have the same, or a different, response than the first user input 210. As shown in Figure 9 the second input 210 may also cause a reduction 211 to a comfort humidification level. However, in the example there is not further attempt to increase the humidity. Alternatively, the humidity could be increasedagain, but at a yet lower rate, or after a longer time period at the comfort humidification level.
[0292] Figure 10 shows an example where the user input 210 (or variously a trigger) causes a reduction 21 1 to the humidification level followed by a slower increase rate. Any reduction 21 1 will typically not fall lower than the initial humidification level to ensure progress is being made towards the therapeutic humidification level. A reduction below this level may require authorisation from a clinician, for example. Figure 10 shows an example where the desired session humidity rate has also been reduced to a reduced session humidification level 274, so that the session humidification transition 204 will no longer have the same increment as initially configured. This may avoid the patient believing they will never be comfortable and / or establishing a new comfort level of humidification for later sessions. Figure 10 shows a second user input 210, after which the rate of increase is again reduced. The desired humidity for the session may also be reduced, or the first reduced desired humidity 274 may be kept.
[0293] Figure 10 also shows a non-linear humidity curve at the beginning of the humidification transition 204. This curve, or a similar curve may provide an initial period providing a comfortable start to a therapy session. The shown curve starts at a low humidity and increasing to or above a comfort humidification level quickly. A slower, in the case of Figure 10, linear, rate of increase may then be used to attempt to comfortably reach the desired session humidification level. As shown in Figure 10 the comfort humidification level of a patient may vary. Even within a session. For example, the second trigger causes a drop to the comfort level 273, but this level is now above the previous comfort level. This slight improvement is due to the further exposure of the patient to higher humidities.
[0294] Alternative responses to the user input are possible, separately or as combined options. For example, the humidification level may be held constant instead of any further increase, or the rate of increase may be reduced with or without a first reduction to the humidification level. The user input may be one of a plurality of inputs, each input providing a different requested response.
[0295] Figure 11 shows an alternative response. In response to the user input the desired session humidification level 240 is decreased 274 as well as the current humidification level being decreased. The desired humidification level 240, 274 may be decreased in proportion to the difference between the humidification level when the user input was received and the reduction in humidification level. In some cases the desired humidification level may be reduced based on other parameters. For example, the length of time remaining in the session, or the desired session.
[0296] Figure 12 shows an alternative response. In response to the user input 210 the humidification level is dropped to a reduced humidification level 274 and remains at the reduced humidification level 274 for the remainder of the session. In a further alternative the humidity could return to the, or substantially the same humidity at which the user input was triggered. It may remain at this point for the remaining session. This can increase the comfort level humidity for the patient as much as possible.
[0297] Figure 22 shows an example session humidification transition 204. In this case an indication of patient discomfort has been received causing modifications 211 , 221 , 231 to the humidification transition 204. Each modification reduces the humidification level be an amount. However, the amount of reduction of humidification level is dependent on the closeness to the desired session humidification level 230. As show the reduction reduces with greater humidification level. This may occur even when the indications of patient discomfort are independent. For example, taking curve 214 as separate from transition 204 and 224, a first reduction 221 is smaller than the corresponding first reduction of curve 204, but larger than the first reduction 231 on curve 224. In some cases, the reduction reduces with consecutive indications of discomfort. For example, the second reduction 221 on transition 204 is smaller than the first reduction 21 1 and the third reduction 231 smaller than the second reduction 221. This may limitthe ability of a patient to avoid some increase in humidification level during a session.
[0298] The user input requires a user to provide the input to the apparatus 10. However, the apparatus 10 may have one or more sensors to identify events, such as adherence events. Events may include the detection of a patient interface being removedor user changes to the humidification parameters. The multi-session humidification transition, or session humidification transitions could be changed based on these events, similar to the changes made based on user inputs. For example if the apparatus detects that a patient has removed their patient interface the responses may be as with the user input. In some cases the apparatus 10 reviews the prior humidification data to identify patterns and / or consistent events. For example, if a patient is consistently removing the interface at the same or similar time point within a session the session humidification transition 204 could be modified. For example, the humidity at or near the time point where the patient removes the interface could be reduced so as to make the patient more comfortable at the point where they are likely, based on the previous data, to stop or pause treatment. This modification may be temporary (i.e. limited to the session humidity transition) or permanent (modifying a feature of the multi-session humidification transition 250). This may depend on the patient response to the modification. After a period of time the humidity may be increased, optionally back to the desired session humidification level 240. In some cases one or more of the time period before reducing humidity, the time period of operation at the reduced humidity and the time period for increasing the humidity are determined from session parameters and / or the humidification parameters. The session parameters may include the average time of interface removal and the average session length of the patient.
[0299] Figures 7 to 12 and 22 show session humidity transitions 204. However, it will be understood that these may be combined in a series of sessions 202 to form a humidity transition 250 as shown in Figure 5. The various user triggers 210 and modifications to the transitions 204 may affect only the session 202 in which they occur or could be passed to alter sessions so as to impact the overall humidity transition 250. Using this combination of session humidity transitions 204 to build the overall humidity transition 250 ensures comfort throughout the process.
[0300] The modification of the multi-session humidification transition could be automatic. Alternatively the patient and / or a clinician may be prompted to accept or configure the modification. In some cases clinicians could define rules that the patient's humidification transitions must adhere to. For example, a clinician may require a certainamount of time at an operational humidification level / flow rate and a minimum session length.
[0301] A patient removing the interface during a therapy session could be a sign that they are uncomfortable with an aspect of the therapy. In some cases the apparatus 10 uses measurements from flow sensors and pressure sensors to detect when the interface has been removed. For example a flow signal and / or a pressure signal. In some cases a lack of flow oscillation or a lack of pressure oscillation may be used. However, interface removal does not necessarily mean the patient is uncomfortable. For example, the patient could be pausing therapy for an independent reason. For example going to the bathroom or getting up to answer the door or eating. In some cases the apparatus is configured to present a prompt to the patient when resuming therapy. The prompt may request a reason for the interface removal.
[0302] The number of patient interface 51 removals may be compared to a predefined threshold before the controller takes an action. This reduces unnecessary modifications to the transitions. The interface removals may be considered by one or more of the number of removals in one session, the number of removals in each session over a plurality of sessions (e.g., a week of sessions), a trend of change in the number of removals between two or more sessions (optionally accounting for usage time in each session). These may be monitored during acclimatisation, but also during normal usage - to ensure the patient comfort has not reduced with time.
[0303] In some cases the user interface 51 of the apparatus 10 could be used to provide feedback on interface removals. For example, if the replacement of a patient interface 51 is detected after a removal event is detected, a prompt could appear on the user interface. The prompt may ask the patient why they removed the interface 51. In one example the prompt is a multichoice question with one or more options.
[0304] Environmental conditions while the patient is having therapy can have a large effect on the response to the therapy. For example, in a tropical environment (high temperature, high humidity, high dew point) a patient may not be as receptive to operational humidification levels. This may be because their body is stressed coping with their environment. In some cases the humidification parameters may include or may beadditional to one or more environmental parameters. Environmental parameters may include one or more of ambient temperature, ambient humidity and time of day. The environmental parameters may be used to consider, for example, any mitigating factors in the prior sessions. These, optionally in combination with current environmental parameters may be used to determine suitable humidification parameters for the current session.
[0305] For example, on a hotter day a high dew point may be more uncomfortable for a patient relative to on a colder day. The session humidification transition 204 of a following session may not need to be modified if the next session occurs on a colder day. In some cases if sensors indicate that adverse environmental conditions are diminishing the patient's capacity to complete their prescribed therapy protocol the session humidification transition could be modified.
[0306] In some cases the respiratory apparatus 10 is used during sleep, typically overnight. For example for COPD patients overnight NHF is recommended. The length of a therapy session during sleep is dependent on when the patient goes to bed (starts therapy) and when they wake up (end therapy). This means therapy is often driven by a patient's sleep schedule rather than their comfort with the therapy. For example, if a patient goes to bed at 11 pm and must be up at 5am to get to work, the therapy session is limited to 6 hours. This is irrespective of how comfortable the patient finds the therapy. In some cases this means that the apparatus 10 must consider the time and / or the type of therapy session when considering prior humidification parameters and / or adherence and / or patient comfort. The session times may be obtained by a clock or timing device associated with the apparatus. Determination of a session type, such as a night session, may allow a different transition to be applied.
[0307] In some cases the use of the apparatus 10 overnight allows a long therapy session. The apparatus 10 may modify the humidification transition 250, 204 to take advantage of this long session. In some cases the use of the apparatus 10 overnight allows a predictable end point, because of a consistent wake-up time or because of linked alarm information, for example. In some cases specific sleep session humidification transition 202 is implemented. For example the session humidification transition 202could have a length calibrated to align with the time the patient usually rises. For example, the session humidification transition 202 could ensure that a patient receives a minimum time of operational-level humidity therapy before the predicted end of the session. In one example if the patient begins therapy at 2am and is known to get up at 7am, the session humidification transition 202 could be set to ensure that the patient receives at least an hour of desired session humidification level 240 before they get up. A similar approach could be applied to other predicted events or apparatus 10 usages, such as regular uses by a patient and / or certain times when usage is known to be paused. For example, at mealtimes.
[0308] In some cases a humidification level is reduced during a session, for example a sleep session, to conserve water. This can prevent low water during overnight sessions. In some cases the humidity is increased to deliver the desired session humidity 240 for a final time period of the session. The time period may be at least 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes or 1 hour, for example. This time period may be identified based, at least in part, on prior session humidification parameters, such as the lengths of prior sessions. In some cases the amount of water can also be predicted. For example based on a prior time to water-out alarms. In some cases the rate of water usage for the device can be estimated and used to extrapolate the length of time a full tank of water lasts for the for the selected humidification transition, or for humidification parameters. The apparatus 10 can then determine if the session humidification transition 204 should be modified, for example by decreasing humidity to to conserve water. This may be balanced with the desire to provide therapy. For example by increasing the humidity back to the desired session before a predicted end point of the patients' session.
[0309] In some cases the respiratory apparatus 10 is able to provide both high flow therapy and pressure therapy. The apparatus 10 may be referred to as a dual-apparatus. While high flow and pressure apparatus are typical other dual-apparatus may be used if helpful to the patient. The apparatus and method provide a comfortable way to change the humidification parameters for a patient moving between the therapy modes over a plurality of sessions. For example, if changing from a pressure-controlled mode (lowrelative humidity, low dewpoint) to a flow-controlled mode (37 dewpoint, 100%RH) the contrast in humidity delivery between the two modes could be jarring or uncomfortable for the patient. In some cases a multi-session humidification transition 250 is implemented upon changing the therapy modes. The humidification transition has an initial humidification level of the pressure-therapy humidification level and a desired humidification level of the high flow therapy humidification level.
[0310] Figure 13 is a flow chart of an example control method for the apparatus 10. An input is received. Two examples are shown, although other inputs able to provide initial and / or desired humidification parameters may be used. A first example is one or more prior humidification parameters from one or more prior operating sessions 301. Alternatively a clinician and / or user can provide an input 302 of the comfort 304 and desired humidity levels 303. As shown, these may be provided directly, or may be determined by the apparatus based on provided data. In some cases only the desired (e.g. a therapeutic level of humidity 303) may be provided with a comfort level assumed or tested for. Based on one or more of the desired 303 and comfort 304 levels the apparatus determines a multi-session humidity transition 305. This could comprise the end points for each session, or one or more profiles for each session. Once determined the settings may be applied to each session 306. The apparatus may be able to determine the transition on a session by session basis (i.e. determining the current session at the beginning of the session, or at the end of the prior session). Alternatively multiple sessions may be determined at once. In some cases these sessions may be modified if required or helpful for patient comfort, for example.
[0311] Figure 14 shows a flow chart for an example control method focussing on user / clinician input. 401. Based on the input the apparatus 10 may determine a desired therapy 403 and / or comfort / initial levels 403. These may be used to determine the multi session humidity transition. However, it is also possible the apparatus is configured to receive a humidity transition 407 directly from the user / clinician. The apparatus 10 may then be configured to set the humidification parameters 406 based on either of these. In some cases the preset humidification transition may have to be modified based on patient feedback.
[0312] Figure 15 shows a flow chart of an example modification of humidification setting. The apparatus 10 may be applying a humidity transition set for one or a plurality of sessions 501. In either case a humidification transition has been identified for the current session 503. The humidification parameters have been set or are or will be controlled to achieve this 506. As described above a user or clinician input 507 and / or event or sensor feedback 508 may be received. Based on the received feedback the session humidity transition may be modified 51 O to improve comfort. Optionally this may also require a modification of the humidity transition of other sessions, depending on, for example, if the expected comfort level is obtained after the modification.
[0313] Figure 17 shows a flow chart of a processes for a time-based multi-session parameter transition. In process 601 a multi-session parameter transition is determined based on elapsed time 602. This specifies a parameter level for each time of the time period of the transition. Examples include a constant ramp, a series of incremental increases, or a more complex profile. In each session the parameter level (s) forthe session can be determined by determining the elapsed time of operation 603. The operating parameters may then be set 604 on the respiratory apparatus. This process 601 may be simple to apply - it is possible to control through a simple comparison of elapsed time and the multi-session parameter transition. In some cases the time of operation may be adjusted. Example adjustments include any one or more of omitting an initial period or final period (e.g. warm-up or warm-down periods), omitting periods where therapy is not being received by the patient, omitting periods in certain modes of operations, omitting periods in certain types or therapy, or omitting periods in certain types of sessions, omitting periods where the patient not wearing the patient interface; omitting periods where the patient has paused the transition and / or adding periods of treatment on other respiratory apparatus.
[0314] Aspects of the controller and methods described above may be operable or implemented on any type of specific-purpose or special computer, or any machine or computer or server or electronic device with a microprocessor, processor, microcontroller, programmable controller, or the like, or a cloud-based platform or other network of processors and / or servers, whether local or remote, or any combination ofsuch devices. Although figures 13 to 15 have been described using humidification as a parameter any parameter, or combinations of parameters may be used similarly.
[0315] The controller 1 19 described in connection with the examples disclosed herein may be implemented or performed with 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, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, 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, a number of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
[0316] The methods or algorithms described in connection with the examples disclosed herein may be embodied directly in hardware, in a software module executable by a processor, or in a combination of both, in the form of processing unit, programming instructions, or other directions, and may be contained in a single device or distributed across multiple devices. A software module may reside a storage medium such as RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD- ROM, or any other form of storage medium known in the art. A storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor.
[0317] In its various aspects, embodiments of the disclosure can be embodied in a computer-implemented process, a machine (such as an electronic device, or a general purpose computer or other device that provides a platform on which computer programs can be executed), processes performed by these machines, or an article of manufacture. Such articles can include a computer program product or digital information product in which a computer readable storage medium containing computer program instructionsor computer readable data stored thereon, and processes and machines that create and use these articles of manufacture.
Claims
1. CLAIMS1. A respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the humidifier, wherein the controller is configured to: obtain one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more operating parameters based on the one or more prior operating parameters, and set the one or more operating parameters of the humidifier.
2. The respiratory apparatus of claim 1 wherein the one or more operating parameters comprise one or more humidification parameters.
3. The respiratory apparatus of claim 2 wherein the one or more humidification parameters and / or the one or more prior humidification parameters comprise any one or more of: a humidification set point, a desired humidification level, a delivered humidity, a maximum previously reached set point, and / or a time period4. The respiratory apparatus of claims 1 to 3 wherein the one or more prior operating parameters comprise timing data from one or more previous operating sessions.
5. The respiratory apparatus of claim 4 wherein timing data comprises a length of one or more previous operating sessions.
6. The respiratory apparatus of claim 5 wherein the timing data comprises an elapsed time since a first operating session.
7. The respiratory apparatus of claims 1 to 6 wherein the controller is configured to determine a multi-session operating parameter transition based on the one or more prior operating parameters.
8. The respiratory apparatus of claim 7 wherein the multi-session operating parameter transition is between an initial operating parameter level and a desired operating parameter level.
9. The respiratory apparatus of claim 8 wherein the initial operating parameter level and / or the desired operating parameter level are humidification set points of the humidifier.
10. The respiratory apparatus of claims 7 to 9 wherein the session operating parameter transition comprises a modification of the one or more operating parameters from the one or more prior operational parameters to or towards one or more desired operating parameters.1 1. The respiratory apparatus of claim 10 wherein session operating parameter transition comprises an increment in the one or more prior humidification parameters.
12. The respiratory apparatus of claims 1 1 wherein the increment is dependent, at least in part, on an adherence parameter of the one or more prior operating sessions.
13. The respiratory apparatus of claims 7 to 12 wherein the controller is configured to determine the session operating parameter transition based on a multi-session operating parameter transition defined for a plurality of operating sessions.
14. The respiratory apparatus of claim 13 wherein the multi-session operating parameter transition is configured to increase the one or more operating parameter to one or more desired operating parameters over a predefined number of sessions and / or predefined time period.
15. The respiratory apparatus of claim 14 wherein the multi-session operating parameter transition comprises a plurality of predefined session operating parameter transitions.
16. The respiratory apparatus of claim 13 to 15 wherein an initial session operating parameter level of each session operating parameter transition increases for each session operating parameter transition of the multi-session operating parameter transition, and / or the desired session operating parameter level of each session operating parameter transition increases for each session operating parameter transition of the multi-session operating parameter transition.
17. The respiratory apparatus of claims 13 to 16 wherein each session operating parameter transition has a fixed time period.
18. The respiratory apparatus of claims 13 or 17 wherein the multi-session operating parameter transition comprises one or more session operating parameter transition profiles.
19. The respiratory apparatus of claims 1 to 17 wherein the controller is configured to receive an input of one or more comfort parameters, optionally wherein the controller is configured to adjust one or more of the operating parameters based on the one or more comfort parameters.
20. The respiratory apparatus of claims 1 to 19 configured to provide a pressure therapy mode.
21. The respiratory apparatus of claim 20 wherein the controller is configured to apply an operating parameter therapy transition when moving between a pressure therapy mode and a high flow mode.
22. The respiratory apparatus of claim 21 wherein the controller is configured to apply an operating parameter transition in both the pressure therapy mode and the high flow mode.
23. The respiratory apparatus of claims 1 to 22 wherein the controller is configured to determine, from the one or more prior operating parameters, any one or more of: a length of one or more prior sessions, a minimum, maximum, initial, final or average operating parameter set point or parameter output of one or more prior sessions, and one or more events during one or more prior sessions.
24. The respiratory apparatus of claim 23 wherein the event is determined by one or more of: removal of a patient interface, unexpected ending of the prior operating session, patient inputs during the prior operating session, flow rate changes, humidification parameter changes, water levels.
25. The respiratory apparatus of claims 1 to 24 wherein the controller is configured to determine the time of day of the one or more prior operating sessions.
26. The respiratory apparatus of claim 1 to 25 wherein the controller is configured to determine an apparatus parameter indicative of any one or more of: a patient beginning therapy; a patient wearing a patient interface; a patient adherence to the apparatus; a patient ceasing therapy; and a patient removing the patient interface.
27. The respiratory apparatus of claim 1 to 26 wherein the one or more operating parameters comprise environmental parameters.
28. The respiratory apparatus of claim 1 to 27 wherein the prior operating session comprises aggregated use of the respiratory apparatus over a time period.
29. A respiratory apparatus for high flow therapy configured to deliver a flow of gases to a patient, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the respiratory apparatus, wherein the controller is configured to: obtain one or more desired operating parameters for delivering therapy to the patient; obtain one or more initial operating parameters for the patient;determine a multi-session operating parameter transition configured to increase the initial operating parameters to the desired operating parameters over a plurality of sessions.
30. The respiratory apparatus of claim 29 wherein the operating parameter transition comprises a plurality of session operating parameter transitions, the plurality of session operating parameter transitions in combination configured to increase the initial operating parameters to the desired operating parameters.
31. A respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a controller configured to control the flow of gases based on one or more operating parameters, wherein the controller is configured to: obtain one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determine the one or more operating parameters based on the one or more prior operating parameters, and set the one or more operating parameters of the respiratory apparatus.
32. A method for controlling a respiratory apparatus for high flow therapy, the method comprising the steps of: obtaining one or more prior operating parameters of the respiratory apparatus from one or more prior operating sessions, determining the one or more operating parameters based on the one or more prior operating parameters, and setting, on the respiratory apparatus, the one or more operating parameters .
33. The method of claim 32 wherein the one or more operating parameters and / or the one or more prior operating parameters comprise any one or more of: an operational set point, a desired operating level, a flow rate, pressure, humidity, gases concentration, or temperature,a maximum previously reached set point, and / or a time above a threshold parameter.
34. A method for controlling a respiratory apparatus for high flow therapy the method comprising the steps of : obtaining one or more desired operating parameters for delivering therapy to the patient; obtaining one or more initial operating parameters for the patient; determining a multi-session parameter transition configured to increase the initial operating parameters to the desired operating parameters over a plurality of sessions.
35. A respiratory apparatus for high flow therapy configured to deliver a flow of gases, the respiratory apparatus comprising: a humidifier configured to humidify the flow of gases based on one or more operating parameters, and a controller configured to control the humidifier by adjusting a humidity set point of the humidifier based on the one or more operating parameters, wherein the controller is configured to increase the humidity set point of the humidifier over a plurality of therapy sessions, to increase the humidity of the delivered flow of gases over the plurality of sessions.
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