Medical devices, their operating methods, medical systems, and programs

Abstract

To improve the continuity of treatment. [Solution] The medical device includes a supply unit (106, 122, 125) that supplies air to the patient's airway at therapeutic pressure, and a processor (112). The processor is configured to increase the therapeutic pressure by a first amount when a first condition relating to respiratory distress is met while the therapeutic pressure is below a first threshold, to increase the therapeutic pressure by a second amount when a second condition relating to respiratory distress is met while the therapeutic pressure is high, above the first threshold, and to change the setting of a pressurization parameter for a first operating mode of the medical device, which includes at least one of a first amount, a second amount, a first condition, a second condition, and a first threshold.

Description

TECHNICAL FIELD

[0001] The present invention relates to a medical device, an operating method thereof, a medical system, and a program.

BACKGROUND ART

[0002] As a treatment method for sleep apnea syndrome (SAS), nasal continuous positive airway pressure therapy (CPAP) is known. CPAP is a treatment method that continuously delivers air of an appropriate pressure to the patient's airway through a nasal mask, and prevents obstruction of the airway during sleep, thereby suppressing the occurrence of apnea and hypopnea. Patent Document 1 describes changing the pressure level over time.

PRIOR ART DOCUMENTS

PATENT DOCUMENTS

[0003]

PATENT DOCUMENT 1

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0004] In a CPAP device, parameter values for changing the treatment pressure to be optimal for treatment are preset by the vendor. However, if the treatment pressure is too high, the patient may feel uncomfortable using the CPAP device and discontinue its use at their own discretion. Some aspects of the present invention aim to provide a technique for improving the continuity of treatment.

MEANS FOR SOLVING THE PROBLEMS

[0005] According to some embodiments, a medical device is provided, comprising: a supply unit that supplies air to a patient's airway at therapeutic pressure; and a processor, wherein the processor is configured to increase the therapeutic pressure by a first amount when a first condition relating to respiratory distress is met while the therapeutic pressure is below a first threshold; increase the therapeutic pressure by a second amount when a second condition relating to respiratory distress is met while the therapeutic pressure is equal to or greater than the first threshold; and change the setting of a pressure-boosting parameter for a first operating mode of the medical device, the setting of a pressure-boosting parameter including at least one of the first amount, the second amount, the first condition, the second condition, and the first threshold. [Effects of the Invention]

[0006] In some embodiments, the continuity of treatment can be improved. [Brief explanation of the drawing]

[0007] [Figure 1] A block diagram illustrating an example configuration of a CPAP device in some embodiments. [Figure 2] A flowchart illustrating an example of how to change the treatment pressure in some embodiments. [Figure 3A] A schematic diagram illustrating an example of changes in therapeutic pressure in multiple operating modes of some embodiments. [Figure 3B] A schematic diagram illustrating an example of changes in therapeutic pressure in multiple operating modes of some embodiments. [Figure 3C] A schematic diagram illustrating an example of changes in therapeutic pressure in multiple operating modes of some embodiments. [Figure 3D] A schematic diagram illustrating an example of changes in therapeutic pressure in multiple operating modes of some embodiments. [Figure 4] A flowchart illustrating an example of how to change the settings of pressure change parameters in some embodiments. [Figure 5] A schematic diagram illustrating an example of a screen for obtaining treatment parameters in some embodiments. [Figure 6] A schematic diagram illustrating an example of how to change the settings of pressure change parameters in some embodiments. [Figure 7A] A schematic diagram illustrating an example of a method for changing settings of pressure increase parameters according to some embodiments. [Figure 7B] A schematic diagram illustrating an example of a method for changing settings of pressure decrease parameters according to some embodiments. [Figure 8] A schematic diagram illustrating an example of a graph provided to a physician according to some embodiments. [Description of Embodiments]

[0008] Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. Note that the following embodiments do not limit the invention according to the claims, and not all combinations of features described in the embodiments are essential to the invention. Two or more of the plurality of features described in the embodiments may be arbitrarily combined. In addition, the same or similar configurations are denoted by the same reference numerals, and redundant descriptions are omitted.

[0009] <Configuration of CPAP Apparatus> Referring to Figure 1, an example configuration of a continuous positive airway pressure (CPAP) device (hereinafter referred to as a CPAP device) 100 according to one embodiment will be described. The CPAP device 100 is an example of a medical device for treating sleep apnea syndrome. The CPAP device 100 has a main unit 101, a mask 125, and a tube 126 connecting the main unit 101 and the mask 125. The operation of the CPAP device 100 is realized by the CPU (Central Processing Unit) 112 reading a program stored in ROM (Read Only Memory) 113 into RAM (Random Access Memory) 114 and executing it. Thus, a device having a processor such as the CPU 112 and memory such as ROM 113 and RAM 114 may be considered a computer. The function blocks 117 to 122 described in the CPU 112 schematically represent the main functions among the various functions realized by the CPU 112 executing a program. Therefore, the operation described mainly using function blocks 117 to 122 is actually realized by the CPU 112 executing a program. Alternatively, one or more functional blocks may be implemented using hardware circuits other than the CPU 112.

[0010] First, let's describe the components present in the airflow path. The filter 102 is installed at the air intake and removes pollen, bacteria, dust, etc. The temperature sensor 103 measures the temperature of the incoming air. The value measured by the temperature sensor 103 is supplied to the temperature control unit 119. The humidity sensor 104 measures the humidity of the incoming air. The value measured by the humidity sensor 104 is supplied to the temperature control unit 119.

[0011] The flow (differential pressure) sensor 105 (hereinafter simply referred to as the flow sensor 105) is, for example, a differential pressure type flow sensor, and measures the flow rate of air in the flow path based on the pressure difference between the upstream side and the downstream side. Here, it is assumed that a positive measured value is obtained when the pressure on the upstream side is higher than the pressure on the downstream side, and a negative measured value is obtained when the pressure on the downstream side is higher than the pressure on the upstream side. Therefore, the flow direction of the air in the flow path can also be known from the measured value of the flow sensor 105. The measured value of the flow sensor 105 is supplied to the respiration analysis unit 117.

[0012] The blower 106 has an impeller and a motor for driving the impeller inside. The therapeutic pressure control unit 118 controls the rotation speed of the motor through the motor driver 108, whereby the flow rate and supply pressure of the air supplied to the patient's airway can be adjusted.

[0013] The pressure sensor 107 is provided downstream of the blower 106 in the flow path, and measures the pressure in the flow path. The measured value of the pressure sensor 107 is supplied to the therapeutic pressure control unit 118. The therapeutic pressure control unit 118 controls the supply pressure on the assumption that air is being supplied to the patient's airway at the pressure measured by the pressure sensor 107.

[0014] The humidifier 109 has a water storage tank and humidifies the air supplied to the tube 126. Here, the temperature control unit 119 controls the temperature of the heater 110 provided in the humidifier 109, thereby controlling the amount of water vaporized from the water storage tank, that is, the degree of humidification. The temperature sensor 111 measures the temperature of the heater 110 and supplies it to the temperature control unit 119. In the present embodiment, by using the heater 110 in the humidifier 109, the temperature of the air supplied to the patient's airway is adjusted together with humidification. Note that the temperature adjustment of air can also be realized by other methods, for example, using a heater 123 provided in the tube 126. When humidification and temperature adjustment are performed separately, the heater 110 and the temperature sensor 111 may not be provided in the humidifier 109. Alternatively, air may be blown onto the water surface in the water storage tank, or the flow path may be arranged so as to pass through the water.

[0015] The tube 126 connects the main body 101 and the mask 125. The tube 126 has stretchability and flexibility to easily follow the movement of the mask 125. The tube 126 is provided with a temperature sensor 124 that measures the temperature of the air supplied to the patient's airway. The measurement value of the temperature sensor 124 is supplied to the temperature control unit 119.

[0016] The mask 125 has a size and shape that covers the patient's nose and mouth, and is attached to the patient by an adjustable string or band. For example, the blower 106, the mask 125, and the tube 126 constitute a supply unit that supplies air to the patient's airway at a therapeutic pressure.

[0017] The display unit 115 is, for example, a display provided on the housing of the main body 101, and displays messages related to the handling of the CPAP device 100, various menu screens for performing settings of the CPAP device 100, measurement values of various sensors, and the like. The display of the display unit 115 is controlled by the input / output control unit 120.

[0018] The operation unit 116 is a general term for user-operable input devices such as buttons and switches provided on the housing of the main body 101, for example. When the display unit 115 is a touch display, the display unit 115 and the operation unit 116 are configured integrally. The input / output control unit 120 detects an operation on the operation unit 116, and the CPU 112 executes an operation corresponding to the detected operation.

[0019] The respiratory analysis unit 117 detects the occurrence of a predetermined event based on the flow rate measured by the flow sensor 105. When the respiratory analysis unit 117 detects the occurrence of a predetermined event, it notifies the therapeutic pressure control unit 118. In the present embodiment, the respiratory analysis unit 117 may be capable of detecting the occurrence of patient snoring, flow limitation, apnea and hypopnea, and Cheyne-Stokes respiration. Furthermore, the respiratory analysis unit 117 may be capable of detecting the amount of air leak from the mask 125.

[0020] The therapeutic pressure control unit 118 controls the operation of the blower 106 to supply air to the patient's airway at therapeutic pressure based on the measurement value of the pressure sensor 107. The therapeutic pressure control unit 118 also controls the supply pressure in response to notifications from the respiratory analysis unit 117. The therapeutic pressure control unit 118 controls the supply pressure by controlling the rotation speed of the impeller of the blower 106 by, for example, providing the motor driver 108 with the duty cycle of the pulsed voltage applied to the motor. The therapeutic pressure control unit 118 notifies the temperature control unit 119 of the currently set supply pressure.

[0021] The temperature control unit 119 controls the temperature and humidity of the air supplied to the patient's airway by controlling the operation of the heater 110 in accordance with the measured values ​​of the temperature sensor 103, humidity sensor 104, temperature sensor 111, and temperature sensor 124, and the supply pressure notified by the treatment pressure control unit 118. The temperature and humidity of the air supplied to the patient's airway may be those set by the user via the operation unit 116. User settings via the operation unit 116 are notified to the temperature control unit 119, for example, via the input / output control unit 120. The supply pressure is considered because, even if the temperature of the heater 110 is constant, the degree of temperature rise is lower when the flow rate is high than when it is low.

[0022] The communication control unit 121 performs processing related to communication between the main unit 101 and the external system 130. The communication control unit 121 can perform communication with the external system 130 in accordance with one or more known wireless and / or wired communication standards. The external system 130 may be, for example, a hospital medical and treatment data management system or a remote management system for the CPAP device 100. The CPAP device 100 and the external system 130 constitute a medical system.

[0023] The setting change unit 122 changes the settings of the treatment pressure boosting parameters. Specific examples of the boosting parameters will be described later. The setting change unit 122 may also change the settings of the boosting parameters after the change, according to the user's (e.g., physician's) specifications. Alternatively, or in addition to this, the setting change unit 122 may automatically change the settings of the boosting parameters when certain conditions are met.

[0024] <How to change the treatment pressure> Referring to Figure 2, the method by which the CPAP device 100 changes the therapeutic pressure is explained. To reduce the possibility of the patient waking up due to discomfort caused by a rapid increase in therapeutic pressure or developing aerophagia, the CPAP device 100 switches the way it increases the therapeutic pressure depending on whether the current therapeutic pressure is greater than or less than a specific threshold (referred to as the pressure reduction threshold (first threshold)). Specifically, when the current therapeutic pressure is greater than the pressure reduction threshold, the CPAP device 100 increases the therapeutic pressure more gradually than when it is less than the pressure reduction threshold. Furthermore, after increasing the therapeutic pressure, the CPAP device 100 decreases the therapeutic pressure depending on whether no respiratory distress events are detected for a predetermined period of time. If the therapeutic pressure remains high despite no respiratory distress events being detected, the patient may wake up due to discomfort or develop aerophagia. Therefore, the CPAP device 100 switches the way it decreases the therapeutic pressure depending on whether the current therapeutic pressure is greater than or less than a specific threshold (referred to as the blood pressure reduction promotion threshold (third threshold)). Specifically, the CPAP device 100 reduces the treatment pressure more rapidly when the current treatment pressure is higher than the blood pressure reduction threshold compared to when it is lower than the blood pressure reduction threshold.

[0025] Each step of the method in Figure 2 may be performed by the CPU 112 (for example, its therapeutic pressure control unit 118). Specifically, each step is performed by the CPU 112 executing a program read into the RAM 114. Alternatively, at least some steps of the method in Figure 2 may be performed by a dedicated circuit such as an ASIC (Application Specific Integrated Circuit). The method in Figure 2 may be started when the patient instructs the CPAP device 100 to start operation (e.g., therapeutic operation during sleep), when the CPAP device 100 detects that the patient has fallen asleep, or when triggered by another event. The method in Figure 2 may be terminated when the patient instructs the CPAP device 100 to end operation (e.g., therapeutic operation during sleep), when the CPAP device 100 detects that the patient has woken up, or when triggered by another event.

[0026] During the execution of the method shown in Figure 2, the values ​​measured by the flow sensor 105 are continuously supplied to the CPU 112 (e.g., its respiratory analysis unit 117). As described above, the values ​​measured by the flow sensor 105 represent the patient's respiratory flow rate. The CPU 112 samples the flow rate supplied by the flow sensor 105 at a predetermined sampling interval (e.g., 2 ms) and stores the flow rate at each time point as flow rate data in the RAM 114. This flow rate data represents the time series of the patient's respiratory flow rate. By analyzing this flow rate data, the CPU 112 detects when a respiratory distress event has occurred in the patient. The respiratory distress events to be detected include at least one of snoring, flow limitation, hypopnea and apnea, and Cheyne-Stokes respiration.

[0027] In S201, the CPU 112 initiates the supply of air to the patient's airway at a minimum therapeutic pressure. The minimum therapeutic pressure (e.g., 4 cmH2O) is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114.

[0028] After the air supply is started in S201, in S202 the CPU 112 determines whether the current treatment pressure is equal to or greater than the pressure reduction threshold. The pressure reduction threshold is a threshold compared to the current treatment pressure in order to switch the type of pressure boosting process. If the CPU 112 determines that the current treatment pressure is equal to or greater than the pressure reduction threshold (YES in S202), it transitions the process to S205; otherwise (NO in S202), it transitions the process to S203. The pressure reduction threshold (e.g., 10 cmH2O) is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. In the example in Figure 2, S202 is determined to be YES if the current treatment pressure is equal to the pressure reduction threshold. Alternatively, S202 may be determined to be NO if the current treatment pressure is equal to the pressure reduction threshold. Furthermore, if the current therapeutic pressure is equal to the pressure reduction threshold, the CPU 112 may execute both S203 and S205.

[0029] In S203, the CPU 112 determines whether the normal pressurization condition (first condition) has been met. If the CPU 112 determines that the normal pressurization condition has been met (YES in S203), it executes S204 and then proceeds to S207; otherwise (NO in S203), it proceeds to S207. The normal pressurization condition is the condition for increasing the therapeutic pressure while the current therapeutic pressure is below the pressurization reduction threshold. The normal pressurization condition is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The normal pressurization condition may also include the detection of a predetermined number of respiratory distress events since the start of air supply at the current therapeutic pressure.

[0030] If the normal pressure boosting conditions are determined to be met, in S204, the CPU 112 increases the treatment pressure by the normal pressure boost amount (first amount). The normal pressure boost amount is the amount by which the treatment pressure is increased while the current treatment pressure is below the pressure boost reduction threshold. The normal pressure boost amount (e.g., 1 cmH2O) is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The pressure boosting process using the normal pressure boosting conditions and normal pressure boost amount, as performed in S203 and S204, is referred to as the normal pressure boosting process.

[0031] In S205, the CPU 112 determines whether the mitigation-to-pressure boosting condition (second condition) has been met. If the CPU 112 determines that the mitigation-to-pressure boosting condition has been met (YES in S205), it executes S206 and then proceeds to S207; otherwise (NO in S205), it proceeds to S207. The mitigation-to-pressure boosting condition is the condition for increasing the therapeutic pressure while the current therapeutic pressure is above the pressure boosting-to-pressure boosting threshold. The mitigation-to-pressure boosting condition is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The mitigation-to-pressure boosting condition may also include the detection of a predetermined number of respiratory distress events since the start of air supply at the current therapeutic pressure.

[0032] If the reduced pressure boosting condition is determined to be met, in S206, the CPU 112 increases the treatment pressure by the reduced pressure boosting amount (second amount). The reduced pressure boosting amount is the amount by which the treatment pressure is increased while the current treatment pressure is above the pressure boosting threshold. In S206, the CPU 112 ensures that the treatment pressure does not exceed the maximum treatment pressure. For example, if increasing the treatment pressure by the reduced pressure boosting amount would cause the treatment pressure to exceed the maximum treatment pressure, the CPU 112 may choose not to increase the treatment pressure, or it may increase the treatment pressure to the maximum treatment pressure. The reduced pressure boosting amount (e.g., 0.5 cmH2O) and the maximum treatment pressure (e.g., 20 cmH2O) are pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The pressure boosting process using the reduced pressure boosting condition and reduced pressure boosting amount, as performed in S205 and S206, is referred to as the reduced pressure boosting process. CPU112 may stop increasing the therapeutic pressure even before the therapeutic pressure reaches the maximum therapeutic pressure. For example, if the detected respiratory distress event is central apnea, increasing the therapeutic pressure may not resolve the apnea and may only disrupt the patient's sleep. Also, if the physician suspects that the patient's apnea is central, it may be better not to increase the therapeutic pressure more than necessary. In such cases, CPU112 may set the reduction in pressure to 0 even if the therapeutic pressure does not reach the maximum therapeutic pressure.

[0033] The normal vasopressor conditions, normal vasopressor volume, reduced vasopressor conditions, and reduced vasopressor volume are set so that the therapeutic pressure increases more gradually in the reduced vasopressor treatment than in the normal vasopressor treatment. For example, the normal vasopressor conditions and reduced vasopressor conditions may be the same, and the reduced vasopressor volume may be smaller than the normal vasopressor volume (for example, the reduced vasopressor volume may be half of the normal vasopressor volume). Alternatively, the normal vasopressor volume and reduced vasopressor volume may be the same, and the reduced vasopressor conditions may be more difficult to satisfy than the normal vasopressor conditions. The statement that the reduced vasopressor conditions are more difficult to satisfy than the normal vasopressor conditions means that the reduced vasopressor conditions are a sufficient condition for normal vasopressor, but not a necessary condition. For example, the number of respiratory distress events detected to satisfy the reduced vasopressor conditions may be greater than the number of respiratory distress events detected to satisfy the normal vasopressor conditions. Furthermore, the reduced vasopressor volume may be smaller than the normal vasopressor volume, and the reduced vasopressor conditions may be more difficult to satisfy than the normal vasopressor conditions.

[0034] In S207, the CPU 112 determines whether the current treatment pressure is equal to or greater than the blood pressure reduction threshold. The blood pressure reduction threshold is a threshold compared to the current treatment pressure in order to switch the type of blood pressure reduction treatment. If the CPU 112 determines that the current treatment pressure is equal to or greater than the blood pressure reduction threshold (YES in S207), it transitions the process to S210; otherwise (NO in S207), it transitions the process to S208. The blood pressure reduction threshold (for example, 10 cmH2O) is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. In the example in Figure 2, if the current treatment pressure is equal to the blood pressure reduction threshold, it is determined to be YES in S207. Alternatively, if the current treatment pressure is equal to the blood pressure reduction threshold, it may be determined to be NO in S207. Furthermore, if the current treatment pressure is equal to the blood pressure reduction threshold, the CPU 112 may execute both S208 and S210.

[0035] In S208, the CPU 112 determines whether the normal blood pressure reduction condition (the fourth condition) has been met. If the CPU 112 determines that the normal blood pressure reduction condition has been met (YES in S208), it executes S209 and then proceeds to S202; otherwise (NO in S208), it proceeds to S202. The normal blood pressure reduction condition is the condition for reducing the therapeutic pressure while the current therapeutic pressure is below the blood pressure reduction threshold. The normal blood pressure reduction condition is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The normal blood pressure reduction condition may also include the fact that no respiratory distress event has been detected for a predetermined time since the start of air supply at the current therapeutic pressure.

[0036] If the normal blood pressure reduction conditions are determined to be met, in S209, the CPU 112 reduces the treatment pressure by the normal blood pressure reduction amount (the fourth amount). The normal blood pressure reduction amount is the amount by which the treatment pressure is reduced while the current treatment pressure is below the blood pressure reduction promotion threshold. In S209, the CPU 112 ensures that the treatment pressure does not fall below the minimum treatment pressure. For example, if reducing the treatment pressure by the normal blood pressure reduction amount would cause the treatment pressure to fall below the minimum treatment pressure, the CPU 112 may choose not to reduce the treatment pressure, or it may reduce the treatment pressure to the minimum treatment pressure. The normal blood pressure reduction amount (e.g., 0.5 cmH2O) and the minimum treatment pressure (e.g., 4 cmH2O) are pre-set by the physician or the vendor of the CPAP device 100 and stored in the RAM 114. The blood pressure reduction process using the normal blood pressure reduction conditions and normal blood pressure reduction amount, as performed in S208 and S209, is referred to as the normal blood pressure reduction process.

[0037] In S210, the CPU 112 determines whether the facilitated blood pressure reduction condition (the fifth condition) has been met. If the CPU 112 determines that the facilitated blood pressure reduction condition has been met (YES in S210), it executes S211 and then proceeds to S202; otherwise (NO in S210), it proceeds to S202. The facilitated blood pressure reduction condition is the condition for reducing the therapeutic pressure while the current therapeutic pressure is above the facilitated blood pressure threshold. The facilitated blood pressure reduction condition is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The facilitated blood pressure reduction condition may also include the detection of a predetermined number of respiratory distress events since the start of air supply at the current therapeutic pressure.

[0038] If the conditions for accelerated blood pressure reduction are determined to be met, in S211, the CPU 112 reduces the therapeutic pressure by the accelerated blood pressure reduction amount (the fifth amount). The accelerated blood pressure reduction amount is the amount by which the therapeutic pressure is reduced while the current therapeutic pressure is above the accelerated blood pressure reduction threshold. The accelerated blood pressure reduction amount (for example, 1 cmH2O) is pre-set by a physician or the vendor of the CPAP device 100 and stored in the RAM 114. The blood pressure reduction process using the accelerated blood pressure reduction conditions and accelerated blood pressure reduction amount, as performed in S210 and S211, is referred to as accelerated blood pressure reduction processing.

[0039] The normal blood pressure reduction conditions, normal blood pressure reduction amount, accelerated blood pressure reduction conditions, and accelerated blood pressure reduction amount are set so that therapeutic pressure decreases more rapidly in accelerated blood pressure reduction treatment than in normal blood pressure reduction treatment. For example, the normal blood pressure reduction conditions and accelerated blood pressure reduction conditions may be the same, and the accelerated blood pressure reduction amount may be greater than the normal blood pressure reduction amount (for example, the accelerated blood pressure reduction amount is twice the normal blood pressure reduction amount). Alternatively, the normal blood pressure reduction amount and the accelerated blood pressure reduction amount may be the same, and the accelerated blood pressure reduction conditions may be easier to meet than the normal blood pressure reduction conditions. Easier to meet than the normal blood pressure reduction conditions means that the accelerated blood pressure reduction conditions are a necessary condition for normal blood pressure reduction, but not a sufficient condition. For example, the number of respiratory distress events detected to meet the accelerated blood pressure reduction conditions may be less than the number of respiratory distress events detected to meet the normal blood pressure reduction conditions. Furthermore, the accelerated blood pressure reduction amount may be greater than the normal blood pressure reduction amount, and the accelerated blood pressure reduction conditions may be easier to meet than the normal blood pressure reduction conditions.

[0040] In the method shown in Figure 2 above, the CPAP device 100 selects and executes one of two types of pressure boosting processes (normal pressure boosting and reduced pressure boosting) by comparing the current treatment pressure against one threshold (pressure boosting / reduction threshold). Alternatively, the CPAP device 100 may select and execute one of two or more types of pressure boosting processes by comparing the current treatment pressure against two or more thresholds. The two or more types of pressure boosting processes may include, in addition to the normal pressure boosting and reduced pressure boosting processes described above, a process that increases the treatment pressure more rapidly than the normal pressure boosting process.

[0041] For example, when treatment with the CPAP device 100 begins, the patient's sleep is light, so a rapid increase in treatment pressure from the minimum treatment pressure could cause the patient to wake up. Therefore, the CPAP device 100 performs a mitigating pressure boost while the current treatment pressure is close to the minimum treatment pressure. On the other hand, once the patient is in a sufficiently deep sleep, has experienced respiratory distress multiple times, and the treatment pressure has risen to a certain extent, the likelihood of the patient waking up is low, so the CPAP device 100 performs a normal pressure boost.

[0042] Specifically, CPU112 performs a downward pressure reduction boosting process while the current treatment pressure is greater than or equal to the minimum treatment pressure and less than the downward pressure reduction threshold (second threshold). CPU112 performs a normal pressure boosting process while the current treatment pressure is greater than or equal to the downward pressure reduction threshold and less than the upward pressure reduction threshold (first threshold). In this example, CPU112 performs a normal pressure boosting process instead of a downward pressure reduction boosting process when the current treatment pressure is equal to the downward pressure reduction threshold. Alternatively, CPU112 may perform a downward pressure reduction boosting process instead of a normal pressure boosting process when the current treatment pressure is equal to the downward pressure reduction threshold. The same applies to the processing when the pressure is equal to the other thresholds described below. CPU112 performs an upward pressure reduction boosting process while the current treatment pressure is greater than or equal to the upward pressure reduction threshold and less than or equal to the maximum treatment pressure. The downward pressure reduction threshold and the upward pressure reduction threshold are thresholds compared to the current treatment pressure in order to switch the type of pressure boosting process. The downward pressure reduction threshold is smaller than the upward pressure reduction threshold. Both the downward pressure reduction and upward pressure reduction processes are processes that increase the therapeutic pressure more gradually than normal processes, similar to the pressure reduction and pressure reduction processes described above. The pressure reduction and pressure reduction conditions (third condition) in the downward pressure reduction and pressure reduction process may be the same as or different from the pressure reduction and pressure reduction conditions (second condition) in the upward pressure reduction and pressure reduction process. The amount of pressure reduction and pressure increase (third amount) in the downward pressure reduction and pressure reduction process may be the same as or different from the amount of pressure reduction and pressure increase (second amount) in the upward pressure reduction and pressure reduction process.

[0043] In the example above, CPU 112 switches between boosting processes using a lower boost reduction threshold and an upper boost reduction threshold. Alternatively, CPU 112 does not need to use the upper boost reduction threshold. In this case, CPU 112 performs a lower boost reduction boosting process while the current treatment pressure is greater than or equal to the minimum treatment pressure and less than the lower boost reduction threshold. CPU 112 performs a normal boosting process while the current treatment pressure is greater than or equal to the lower boost reduction threshold and less than the maximum treatment pressure.

[0044] In the method shown in Figure 2 above, the CPAP device 100 selects and executes one of two types of blood pressure reduction treatments (normal blood pressure reduction treatment and accelerated blood pressure reduction treatment) by comparing the current therapeutic pressure against one threshold (hypertensive threshold). Alternatively, the CPAP device 100 may select and execute one of two or more types of blood pressure reduction treatments by comparing the current therapeutic pressure against two or more thresholds. The two or more types of blood pressure reduction treatments may include, in addition to the normal blood pressure reduction treatment and accelerated blood pressure reduction treatment described above, a treatment that reduces the therapeutic pressure more gradually than the normal blood pressure reduction treatment.

[0045] For example, if the current therapeutic pressure is close to the minimum therapeutic pressure, it is assumed that no respiratory distress events have occurred in the patient for some time. Therefore, the CPAP device 100 performs accelerated blood pressure reduction while the current therapeutic pressure is close to the minimum therapeutic pressure.

[0046] Specifically, CPU 112 performs a downward accelerated blood pressure reduction process when the current treatment pressure is above the minimum treatment pressure and below the downward accelerated blood pressure reduction threshold (the fourth threshold). CPU 112 performs a normal blood pressure reduction process when the current treatment pressure is above the downward accelerated blood pressure reduction threshold and below the upward accelerated blood pressure reduction threshold (the third threshold). CPU 112 performs an upward accelerated blood pressure reduction process when the current treatment pressure is above the upward accelerated blood pressure reduction threshold and below the maximum treatment pressure. The downward accelerated blood pressure reduction threshold and the upward accelerated blood pressure reduction threshold are thresholds compared to the current treatment pressure in order to switch the type of blood pressure reduction process. The downward accelerated blood pressure reduction threshold is smaller than the upward accelerated blood pressure reduction threshold. The downward accelerated blood pressure reduction process and the upward accelerated blood pressure reduction process are processes that reduce the treatment pressure more quickly than the normal process, similar to the accelerated blood pressure reduction process described above. The accelerated blood pressure reduction condition (the sixth condition) in the downward accelerated blood pressure reduction process may be the same as or different from the accelerated blood pressure reduction condition (the fifth condition) in the upward accelerated blood pressure reduction process. The amount of accelerated densitivity in the downward accelerated densitivity process (the sixth amount) may be the same as the amount of accelerated densitivity in the upward accelerated densitivity process (the fifth amount), or it may be different.

[0047] In the example above, CPU 112 switches between lowering the blood pressure using a downward pressure reduction threshold and an upward pressure reduction threshold. Alternatively, CPU 112 does not need to use an upward pressure reduction threshold. In this case, CPU 112 performs downward pressure reduction while the current treatment pressure is above the minimum treatment pressure and below the downward pressure reduction threshold. CPU 112 performs normal pressure reduction while the current treatment pressure is above the downward pressure reduction threshold and below the maximum treatment pressure.

[0048] In the method shown in Figure 2 above and its modified form, the CPAP device 100 selects and executes one of two or more types of boosting processes (such as normal boosting and reduced boosting) and one of two or more types of bucking processes (such as normal bucking and accelerated bucking). Alternatively, the CPAP device 100 may not switch the boosting process (for example, always execute normal boosting) and instead select and execute one of the two types of bucking processes. Furthermore, the CPAP device 100 may not switch the bucking process (for example, always execute normal bucking) and instead select and execute one of the two types of boosting processes.

[0049] <Multiple operating modes> The CPAP device 100 may operate in one operating mode selected from a plurality of operating modes, including a standard mode and a soft mode. The soft mode (first operating mode) is an operating mode that prioritizes adherence (continuity of treatment). The standard mode (second operating mode) is an operating mode that prioritizes therapeutic effect. In soft mode, the CPAP device 100 increases the treatment pressure more gradually and decreases it more rapidly than in standard mode. The plurality of operating modes may include operating modes other than the standard mode and the soft mode. For example, the plurality of operating modes may include a fixed mode in which the treatment pressure is fixed at a value specified by a physician.

[0050] Referring to Figures 3A to 3D, the changes in therapeutic pressure in standard mode and soft mode will be explained. Graph 301 in Figure 3A shows the change in therapeutic pressure over time during hypertension in standard mode. Graph 302 in Figure 3B shows the change in therapeutic pressure over time during hypertension in soft mode. Graph 303 in Figure 3C shows the change in therapeutic pressure over time during hypotension in standard mode. Graph 304 in Figure 3D shows the change in therapeutic pressure over time during hypotension in soft mode. In graphs 301 to 304, Max, Min, Th1, and Th2 represent the maximum therapeutic pressure, minimum therapeutic pressure, hypertension reduction threshold, and hypotension promotion threshold, respectively. The black circles on the horizontal axis of graphs 301 and 302 indicate the time when a respiratory distress event occurred.

[0051] In the examples in Figures 3A and 3B, the normal pressure increase, reduced pressure increase, and pressure reduction thresholds for soft mode are the same as those for standard mode, and the normal and reduced pressure increase conditions for soft mode are more difficult to meet than those for standard mode. Specifically, the normal and reduced pressure increase conditions for soft mode are that two respiratory distress events have been detected since the start of air supply at the current therapeutic pressure. The normal and reduced pressure increase conditions for standard mode are that one respiratory distress event has been detected since the start of air supply at the current therapeutic pressure. Therefore, even if the same respiratory distress events occur in the patient, the therapeutic pressure increases more rapidly in standard mode than in soft mode.

[0052] In the examples in Figures 3C and 3D, the normal antihypertensive conditions, accelerated antihypertensive conditions, and accelerated antihypertensive thresholds for soft mode are the same as those for standard mode, while the normal and accelerated antihypertensive doses for soft mode are smaller than those for standard mode. Specifically, the normal and accelerated antihypertensive conditions for both modes are that no respiratory distress events are detected for a predetermined time (e.g., 3 minutes). The normal antihypertensive dose for soft mode is half the normal antihypertensive dose for standard mode. The accelerated antihypertensive dose for soft mode is half the accelerated antihypertensive dose for standard mode. Therefore, even if no respiratory distress events are detected for the same amount of time, therapeutic pressure decreases more rapidly in standard mode than in soft mode.

[0053] The soft mode described above increases the treatment pressure more gradually and decreases it more rapidly than the standard mode. In addition to or instead of the soft mode, the CPAP device 100 may also be able to operate in a soft depressurizing mode in which the treatment pressure decreases more rapidly than in the standard mode and increases in the same way as in the standard mode, or it may also be able to operate in a soft boosting mode in which the treatment pressure increases more gradually than in the standard mode and decreases in the same way as in the standard mode.

[0054] <How to change settings> Referring to Figure 4, the method by which the CPAP device 100 changes the treatment parameters will be explained. Treatment parameters are parameters related to treatment by the CPAP device 100. Treatment parameters include maximum treatment pressure, minimum treatment pressure, pressure-boosting parameters, and pressure-decreasing parameters. Pressure-boosting parameters are parameters related to increasing treatment pressure in the method shown in Figure 2, and specifically include the normal pressure boost amount, reduced pressure boost amount, normal pressure boost conditions, reduced pressure boost conditions, and pressure boost reduction threshold. Maximum treatment pressure and minimum treatment pressure are not included in the pressure-boosting parameters. Pressure-decreasing parameters are parameters related to decreasing treatment pressure in the method shown in Figure 2, and specifically include the normal pressure-decreasing amount, accelerated pressure-decreasing amount, normal pressure-decreasing conditions, accelerated pressure-decreasing conditions, and accelerated pressure-decreasing threshold. Maximum treatment pressure and minimum treatment pressure are not included in the pressure-decreasing parameters. Pressure-boosting parameters and pressure-decreasing parameters are collectively referred to as pressure change parameters. The following description of pressure change parameters may apply to both boost and buck parameters, to boost parameters only, or to buck parameters only.

[0055] The CPAP device 100 may change all of the pressure change parameters, or only some of them. As described later, the CPAP device 100 may change these settings according to instructions from the user (e.g., a physician), or based on the results of an analysis of respiratory distress events. The CPAP device 100 may store a history of changes to the pressure change parameter settings. For example, the CPAP device 100 may store, in association with the changed settings, at least one of the following: whether the change was made according to instructions from the user, whether the change was made based on the results of an analysis of respiratory distress events, and the date and time the change was made.

[0056] The pressure change parameters that the CPAP device 100 modifies are also referred to as modifiable pressure change parameters. The pressure change parameters that the CPAP device 100 does not modify are also referred to as immutable pressure change parameters. Immutable pressure change parameters are maintained at the initial settings set by the vendor of the CPAP device 100.

[0057] The CPAP device 100 may change the pressure change parameter settings for the soft mode, but not for the standard mode. In this case, the pressure change parameter settings for the standard mode remain unchanged and are maintained at the initial settings set by the vendor of the CPAP device 100. Since the soft mode is a mode that prioritizes adherence, the pressure change parameter settings can be changed to prioritize the patient's comfort with the CPAP device 100. On the other hand, since the standard mode is a mode that prioritizes therapeutic effect, it maintains the optimal settings for treatment determined by the vendor of the CPAP device 100. Alternatively, the CPAP device 100 may also change the pressure change parameter settings for the standard mode. In the following explanation, changes to the pressure change parameter settings are reflected in the soft mode but not in the standard mode (i.e., the original settings are maintained). Alternatively, the CPAP device 100 may also reflect changes to the pressure change parameter settings for the soft mode in the pressure change parameter settings for the standard mode. Furthermore, the CPAP device 100 may change the pressure change parameters for the soft mode and the pressure change parameters for the standard mode separately.

[0058] Each step of the method in Figure 4 may be executed by the CPU 112 (for example, its configuration change unit 122). Specifically, each step is performed by the CPU 112 executing a program read into RAM 114. Alternatively, at least some of the steps of the method in Figure 4 may be performed by a dedicated circuit such as an ASIC. The method in Figure 4 may be started when the power of the CPAP device 100 is turned on, or it may be started in response to other events. The method in Figure 4 may be terminated when the power of the CPAP device 100 is turned off, or it may be terminated in response to other events.

[0059] In S401, CPU112 determines whether the change condition has been met. If CPU112 determines that the change condition has been met (YES in S401), it proceeds to S402; otherwise (NO in S401), it repeats S401. In this way, CPU112 waits until the change condition is met.

[0060] A change condition is a condition for changing the current pressure change parameters. A change condition may include obtaining instructions from a physician, initiating a new treatment with the CPAP device 100, or meeting specific conditions during a single treatment with the CPAP device 100 or between multiple treatments.

[0061] In S402, the CPU 112 determines new settings for the pressure change parameters. In S403, the CPU 112 modifies the settings for the pressure change parameters to match the settings determined in S402. Specifically, the CPU 112 updates the settings for the pressure change parameters stored in RAM 114.

[0062] Referring to Figure 5, the case where the change conditions include obtaining instructions from a physician will be explained. The external system 130 may generate a screen 500 for obtaining instructions from the physician to change the pressure change parameter settings and the new settings for the pressure change parameters, and may provide a user interface including screen 500. Screen 500 is displayed on the physician's client terminal connected to the external system 130.

[0063] Screen 500 may include the objects shown in Figure 5. Object 501 is an object (e.g., a text box) for obtaining the maximum therapeutic pressure from the physician. Object 502 is an object (e.g., a text box) for obtaining the minimum therapeutic pressure from the physician. Object 503 is an object (e.g., a radio button) for obtaining the operating mode of the CPAP device 100 from the physician. In the example of screen 500, either standard mode or soft mode can be selected.

[0064] Object 504 is an object (e.g., a text box) for obtaining the specification of the blood pressure reduction threshold from the physician. The values ​​that can be entered into object 504 may be restricted to a predetermined range (e.g., 6 cmH2O to 12 cmH2O). Object 505 is an object (e.g., a text box) for obtaining the specification of the normal blood pressure increase amount from the physician. Object 506 is an object (e.g., a text box) for obtaining the specification of the reduced blood pressure increase amount from the physician.

[0065] Object 507 is an object (e.g., a text box) for obtaining the specified normal pressor condition from a physician. Specifically, object 507 retrieves the number of respiratory distress events that should be detected for the normal pressor condition to be met. Object 508 is an object (e.g., a text box) for obtaining the specified mitigation pressor condition from a physician. Specifically, object 508 retrieves the number of respiratory distress events that should be detected for the mitigation pressor condition to be met.

[0066] Objects 504-508 may only be editable when soft mode is selected in object 503, and may not be editable when standard mode is selected in object 503. All pressure change parameters are editable on screen 500. If some pressure change parameters are not editable, the objects corresponding to these pressure change parameters will not be displayed. When screen 500 starts displaying, the current pressure change parameter settings may be displayed in objects 501-508.

[0067] Object 509 is an object (e.g., a button) for obtaining instructions from a physician to apply the settings of objects 501-508 to the CPAP device 100. When object 509 is pressed, the external system 130 stores the settings of the treatment parameters specified by objects 501-508, associated with a specific CPAP device 100. The CPAP device 100 periodically or at predetermined intervals obtains new settings of treatment parameters from the external system 130 and decides to use these settings as the new settings. Subsequently, the CPAP device 100 updates the current settings of the treatment parameters stored in RAM 114 to reflect these new settings.

[0068] In the example in Figure 5, screen 500 does not include objects for obtaining specifications of some of the blood pressure reduction parameters (e.g., blood pressure reduction accelerating threshold, blood pressure reduction conditions, blood pressure reduction amount) from the physician, but screen 500 may include these objects. Alternatively, the CPAP device 100 may provide separate screens for obtaining specifications of the blood pressure increasing parameters and for obtaining specifications of the blood pressure decreasing parameters.

[0069] Screen 500 may include the current settings for the pressure change parameters. The current settings for the pressure change parameters displayed on screen 500 may be the settings for the mode selected in object 503. Alternatively, screen 500 may include the current settings for the pressure change parameters for each of the two modes. In this case, the user can compare the settings for the two modes. The current settings for standard mode and the current settings for soft mode may be included in separate screens displayed side by side.

[0070] The CPAP device 100 calculates the degree of change in therapeutic pressure based on the specified settings using the screen 500. If, for example, it is determined that the therapeutic pressure rises rapidly or decreases gradually in soft mode compared to standard mode, the device may refuse to accept such setting changes or may display a warning.

[0071] The screen 500 may be generated by the CPU 112 and displayed on the display unit 115. In this case, the physician specifies the settings for the treatment parameters by operating the control unit 116, and the CPU 112 determines the new settings for the treatment parameters according to this specification and changes the current settings.

[0072] Next, we will describe the case where the change condition includes the initiation of a new treatment with the CPAP device 100. When a new treatment with the CPAP device 100 is initiated (i.e., the patient starts sleeping), the CPU 112 may determine new settings for the patient's pressure change parameters for the soft mode based on information measured by the CPAP device 100 during the patient's previous sleep. For example, the CPU 112 may determine new settings for the patient's pressure change parameters for the soft mode based on the AHI (number of apneas or hypopneas per hour) measured by the CPAP device 100 during the patient's previous sleep. Specifically, the CPU 112 may determine new settings for the pressure change parameters such that the larger the AHI, the easier it is for the treatment pressure to increase (for example, the pressure reduction threshold and the pressure reduction promotion threshold may be increased). Instead of or in addition to AHI, information measured by the CPAP device 100 such as treatment time and the amount of air leakage from the mask 125 may be used.

[0073] Furthermore, the CPU 112 may determine new settings for pressure change parameters by analyzing information measured by the CPAP device 100 during the patient's previous sleep. For example, as shown in Figure 6, the CPU 112 displays the AHI during the patient's previous sleep as a histogram for each treatment pressure. The CPU 112 may determine the treatment pressure that minimizes the frequency of AHI among treatment pressures below a predetermined upper limit as a new pressure reduction threshold.

[0074] Alternatively, or in addition to the above, the CPU 112 may determine new settings for the pressure change parameters for the soft mode based on evaluations from the patient regarding the comfort of using the CPAP device 100. For example, based on an evaluation that treatment with the CPAP device 100 was comfortable, the CPU 112 may determine new settings for the pressure change parameters to make it easier for the treatment pressure to increase (for example, by increasing the pressure reduction threshold and the blood pressure reduction promotion threshold). On the other hand, based on an evaluation that treatment with the CPAP device 100 was uncomfortable, the CPU 112 may determine new settings for the pressure change parameters to make it harder for the treatment pressure to increase (for example, by decreasing the pressure reduction threshold and the blood pressure reduction promotion threshold).

[0075] Alternatively, or in addition to the above, the CPU 112 may determine new settings for the pressure change parameters for the soft mode based on the patient's attribute information. For example, the CPU 112 may determine new settings for the pressure change parameters such that the greater the patient's weight or BMI (Body Mass Index), the more likely the therapeutic pressure is to increase (for example, the pressure reduction threshold and the pressure reduction promotion threshold may be increased).

[0076] Next, we will explain the case where the change conditions include the fulfillment of specific conditions during a single treatment with the CPAP device 100. Referring to Figure 7A, we will explain the change in therapeutic pressure in soft mode. Graph 701 in Figure 7A shows the change in therapeutic pressure over time in soft mode. In Graph 701, Max, Min, Th1, and Th1' represent the maximum therapeutic pressure, minimum therapeutic pressure, the pressure reduction threshold before the change, and the pressure reduction threshold after the change, respectively. The black circles on the horizontal axis of Graph 701 indicate the time when a respiratory distress event occurred.

[0077] The CPU 112 may determine new settings for the pressure change parameters used during the patient's current sleep for the soft mode, based on information measured by the CPAP device 100 during the patient's current sleep. For example, if respiratory distress events are frequently detected during the patient's current sleep (e.g., 20 times within the last 30 minutes), the CPU 112 may determine the treatment pressure at or near that time as a new pressure-reducing threshold. In Figure 7A, assume this condition is met at time t1. Therefore, the CPU 112 determines the treatment pressure Th1' at or near that time as a new pressure-reducing threshold. When respiratory distress events are frequently detected, the treatment pressure increases rapidly in a short period of time. Therefore, by changing the settings of the pressure change parameters to make it less likely for the treatment pressure to increase, the possibility of the patient feeling uncomfortable can be reduced.

[0078] CPU112 may determine a new pressure-up / down threshold for the treatment pressure at or near the time when the number of detected central apneas during the patient's current sleep exceeds a threshold. When the number of detected central apneas is high, increasing the treatment pressure may not alleviate the apneas. Therefore, the patient can be treated appropriately by changing the pressure change parameter settings so that the treatment pressure is less likely to increase.

[0079] Refer to Figure 7B to explain the changes in therapeutic pressure in soft mode. Graph 702 in Figure 7B shows the changes in therapeutic pressure over time in soft mode. In Graph 702, Max, Min, Th2, and Th2' represent the maximum therapeutic pressure, minimum therapeutic pressure, the antihypertensive threshold before modification, and the antihypertensive threshold after modification, respectively. The black circles on the horizontal axis of Graph 702 indicate the time when a respiratory distress event occurred.

[0080] The CPU 112 may determine new settings for the pressure change parameters used during the patient's current sleep for the soft mode, based on information measured by the CPAP device 100 during the patient's current sleep. For example, if respiratory distress events occur a predetermined number of times consecutively during a reduction in therapeutic pressure, the CPU 112 may determine the therapeutic pressure at or near that time as a new blood pressure reduction threshold. In Figure 7B, assume that respiratory distress events occur a predetermined number of times consecutively from time t2 during a reduction in therapeutic pressure. Therefore, the CPU 112 determines the therapeutic pressure Th2' at or near that time as a new blood pressure reduction threshold. This can reduce the likelihood of the patient feeling uncomfortable.

[0081] In the embodiments described above, the CPAP device 100 changes the pressure change parameter settings for the entire standard mode or the entire soft mode. Alternatively, or in addition to this, the CPAP device 100 may change the pressure change parameter settings for each type of respiratory distress event to be detected (e.g., apnea, hypopnea, snoring, flow limitation). For example, in soft mode, the CPAP device 100 may set the pressure boost / reduction threshold for apnea to 10 cmH2O and the pressure boost / reduction threshold for snoring to 7 cmH2O.

[0082] <Providing information for setting pressure change parameters> The CPAP device 100 may provide the physician with information to enable the physician to appropriately determine the settings for pressure change parameters. For example, the CPU 112 may provide the physician with information measured by the CPAP device 100 during the patient's sleep (e.g., treatment time, amount of air leakage from the mask 125, AHI) and the settings for the pressure change parameters used during this sleep (e.g., pressure reduction threshold). The CPU 112 may provide this information to an external system 130. The external system 130 displays this information to the physician in a graph as shown in Figure 8. The physician may use this graph as a reference to determine the settings for the pressure change parameters (e.g., pressure reduction threshold). The graph in Figure 8 may be displayed to the physician by a display unit 115.

[0083] <Summary of Embodiments> (Item 1) It is a medical device, A supply unit that supplies air to the patient's airway at therapeutic pressure, Equipped with a processor, The aforementioned processor, If a first condition relating to respiratory distress is met while the therapeutic pressure is below a first threshold, the therapeutic pressure is increased by a first amount. If a second condition relating to respiratory impairment is met while the therapeutic pressure is above the first threshold, the therapeutic pressure is increased by a second amount. A medical device configured to change the setting of a boost parameter, which includes at least one of the following: a first amount, a second amount, a first condition, a second condition, and a first threshold, for a first operating mode of the medical device. According to this section, the blood pressure parameters can be modified to reduce patient discomfort, thereby improving the patient's adherence to treatment. (Item 2) The aforementioned processor, If the first condition is met while the treatment pressure is above the second threshold and below the first threshold, the treatment pressure is increased by the first amount, The medical device according to item 1, configured to increase the therapeutic pressure by a third amount if a third condition relating to respiratory impairment is met while the therapeutic pressure is below the second threshold. According to this section, the treatment pressure can be precisely adjusted. (Item 3) The aforementioned processor, If the fourth condition regarding respiratory distress is met while the therapeutic pressure is below the third threshold, the therapeutic pressure is reduced by a fourth amount. If a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the therapeutic pressure is reduced by a fifth amount. The medical device according to item 1 or 2, configured to change the setting of a deflationary parameter, which includes at least one of the following for the first operating mode: the fourth amount, the fifth amount, the fourth condition, the fifth condition, and the third threshold. According to this section, blood pressure parameters can be modified to reduce patient discomfort, thereby improving patient adherence to treatment. (Item 4) The aforementioned medical device is The aforementioned processor, To provide a user interface, A medical device according to any one of items 1 to 3, configured to determine a new setting of the boost parameter for the first operating mode in accordance with instructions obtained using the user interface. According to this section, settings determined to reduce patient discomfort can be used. (Item 5) The aforementioned processor, Information measured by the medical device during the patient's previous sleep, The aforementioned patient attribute information, The evaluation of the usability of the medical device obtained from the aforementioned patient, The information measured by the medical device during the patient's sleep, A medical device according to any one of items 1 to 4, configured to determine a new setting of the boost parameter for the first operating mode based on at least one of the following. This section allows you to properly set the boost parameters. (Item 6) The medical device according to any one of items 1 to 5, wherein the processor is configured to maintain the setting of the boost parameter for a second operating mode different from the first operating mode when the boost parameter for the first operating mode is changed. According to this section, medical devices can be set to a mode that prioritizes treatment efficiency. (Item 7) The medical device according to any one of items 1 to 6, wherein the processor is further configured to provide a physician with information measured by the medical device during the patient's sleep and the settings of the blood pressure boosting parameters determined by the processor and used during the sleep. This section allows physicians to appropriately specify the settings for blood pressure escalation parameters. (Item 8) It is a medical device, A supply unit that supplies air to the patient's airway at therapeutic pressure, Equipped with a processor, The aforementioned processor, If the fourth condition regarding respiratory distress is met while the therapeutic pressure is below the third threshold, the therapeutic pressure is reduced by a fourth amount. If a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the therapeutic pressure is reduced by a fifth amount. A medical device configured to change the setting of a deflationary parameter, which includes at least one of the following: the fourth amount, the fifth amount, the fourth condition, the fifth condition, and the third threshold, for the first operating mode of the medical device. According to this section, blood pressure parameters can be modified to reduce patient discomfort, thereby improving patient adherence to treatment. (Item 9) The aforementioned processor, If the fourth condition is met while the treatment pressure is above the fourth threshold and below the third threshold, the treatment pressure is reduced by the fourth amount, A medical device according to item 8, configured to reduce the therapeutic pressure by a sixth amount if a fifth condition relating to respiratory impairment is met while the therapeutic pressure is below the fourth threshold. According to this section, the treatment pressure can be precisely adjusted. (Item 10) The aforementioned medical device is The aforementioned processor, To provide a user interface, The medical device according to item 8 or 9, configured to determine a new setting of the deflation parameter for the first operating mode in accordance with instructions obtained using the user interface. According to this section, settings determined to reduce patient discomfort can be used. (Item 11) The aforementioned processor, Information measured by the medical device during the patient's previous sleep, The aforementioned patient attribute information, The evaluation of the usability of the medical device obtained from the aforementioned patient, The information measured by the medical device during the patient's sleep, A medical device according to any one of items 8 to 10, configured to determine a new setting of the bloat reduction parameter for the first operating mode based on at least one of the following. According to this section, the buck-down parameters can be set appropriately. (Item 12) The medical device according to any one of items 8 to 11, wherein the processor is configured to maintain the setting of the buck-down parameter for a second operating mode different from the first operating mode when the buck-down parameter for the first operating mode is changed. According to this section, medical devices can be set to a mode that prioritizes treatment efficiency. (Item 13) The medical device according to any one of items 8 to 12, wherein the processor is further configured to provide a physician with information measured by the medical device during the patient's sleep and the settings of the blood pressure-lowering parameters determined by the processor and used during the sleep. This section allows physicians to appropriately specify the settings for blood pressure control parameters. (Item 14) A medical system including any one of the medical devices described in item 1 through 13. According to this item, a medical system including the aforementioned medical devices is provided. (Item 15) A method for operating a medical device equipped with a supply unit that supplies air to a patient's airway at therapeutic pressure, A step of increasing the therapeutic pressure by a first amount if a first condition relating to respiratory impairment is met while the therapeutic pressure is below a first threshold, or a step of decreasing the therapeutic pressure by a fourth amount if a fourth condition relating to respiratory impairment is met while the therapeutic pressure is below a third threshold, If a second condition relating to respiratory impairment is met while the therapeutic pressure is above the first threshold, the step is to increase the therapeutic pressure by a second amount, or if a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the step is to decrease the therapeutic pressure by a fifth amount, A method comprising the step of changing the setting of a parameter for a first operating mode of the medical device, the parameter being at least one of the following: a first amount or a fourth amount, a second amount or a fifth amount, a first condition or a fourth condition, a second condition or a fifth condition, a first threshold or a third threshold. According to this section, treatment change parameters can be modified to reduce patient discomfort. This, in turn, improves patient adherence to treatment. (Item 16) A program that causes a computer to perform each step of the method described in item 15. According to this section, a program is provided to perform the method described above.

[0084] The invention is not limited to the embodiments described above, and various modifications and changes are possible within the scope of the gist of the invention. [Explanation of Symbols]

[0085] 100 CPAP devices, 112 CPUs, 130 external systems

Claims

1. It is a medical device, A supply unit that supplies air to the patient's airway at therapeutic pressure, Equipped with a processor, The aforementioned processor, If a first condition relating to respiratory impairment is met while the therapeutic pressure is below a first threshold, the therapeutic pressure is increased by a first amount. If a second condition relating to respiratory impairment is met while the therapeutic pressure is above the first threshold, the therapeutic pressure is increased by a second amount. A medical device configured to change the setting of a boost parameter, which includes at least one of the following: a first amount, a second amount, a first condition, a second condition, and a first threshold, for a first operating mode of the medical device.

2. The aforementioned processor, If the first condition is met while the treatment pressure is above the second threshold and below the first threshold, the treatment pressure is increased by the first amount, The medical device according to claim 1, configured to increase the therapeutic pressure by a third amount when a third condition relating to respiratory impairment is met while the therapeutic pressure is below the second threshold.

3. The aforementioned processor, If the fourth condition regarding respiratory distress is met while the therapeutic pressure is below the third threshold, the therapeutic pressure is reduced by a fourth amount. If a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the therapeutic pressure is reduced by a fifth amount. The medical device according to claim 1, configured to change the setting of a blood pressure reduction parameter including at least one of the following for the first operating mode: the fourth amount, the fifth amount, the fourth condition, the fifth condition, and the third threshold.

4. The aforementioned medical device is The aforementioned processor, To provide a user interface, The medical device according to claim 1, configured to determine a new setting of the boosting parameter for the first operating mode in accordance with instructions obtained using the user interface.

5. The aforementioned processor, Information measured by the medical device during the patient's previous sleep, The aforementioned patient attribute information, The evaluation of the usability of the medical device obtained from the aforementioned patient, The information measured by the medical device during the patient's sleep, The medical device according to claim 1, configured to determine a new setting of the boosting parameter for the first operating mode based on at least one of the following.

6. The medical device according to claim 1, wherein the processor is configured to maintain the setting of the boost parameter for a second operating mode different from the first operating mode when the boost parameter for the first operating mode is changed.

7. The medical device according to claim 1, wherein the processor is further configured to provide a physician with information measured by the medical device during the patient's sleep and the settings of the blood pressure boosting parameters determined by the processor and used during the sleep.

8. It is a medical device, A supply unit that supplies air to the patient's airway at therapeutic pressure, Equipped with a processor, The aforementioned processor, If the fourth condition regarding respiratory distress is met while the therapeutic pressure is below the third threshold, the therapeutic pressure is reduced by a fourth amount. If a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the therapeutic pressure is reduced by a fifth amount. A medical device configured to change the setting of a deflationary parameter, which includes at least one of the following: the fourth amount, the fifth amount, the fourth condition, the fifth condition, and the third threshold, for the first operating mode of the medical device.

9. The aforementioned processor, When the fourth condition is met while the treatment pressure is above the fourth threshold and below the third threshold, the treatment pressure is reduced by the fourth amount, The medical device according to claim 8, configured to reduce the therapeutic pressure by a sixth amount if a fifth condition relating to respiratory impairment is met while the therapeutic pressure is below the fourth threshold.

10. The aforementioned medical device is The aforementioned processor, To provide a user interface, The medical device according to claim 8, configured to determine a new setting of the deflation parameter for the first operating mode in accordance with instructions obtained using the user interface.

11. The aforementioned processor, Information measured by the medical device during the patient's previous sleep, The aforementioned patient attribute information, The evaluation of the usability of the medical device obtained from the aforementioned patient, The information measured by the medical device during the patient's sleep, The medical device according to claim 8, configured to determine a new setting of the deflation parameter for the first operating mode based on at least one of the following.

12. The medical device according to claim 8, wherein the processor is configured to maintain the setting of the buck-down parameter for a second operating mode different from the first operating mode when the buck-down parameter for the first operating mode is changed.

13. The medical device according to claim 8, wherein the processor is further configured to provide a physician with information measured by the medical device during the patient's sleep and the settings of the blood pressure-lowering parameters determined by the processor and used during the sleep.

14. A medical system comprising a medical device according to any one of claims 1 to 13.

15. A method for operating a medical device equipped with a supply unit that supplies air to a patient's airway at therapeutic pressure, The steps include: increasing the therapeutic pressure by a first amount if a first condition relating to respiratory impairment is met while the therapeutic pressure is below a first threshold; or decreasing the therapeutic pressure by a fourth amount if a fourth condition relating to respiratory impairment is met while the therapeutic pressure is below a third threshold; If a second condition relating to respiratory impairment is met while the therapeutic pressure is above the first threshold, the step is to increase the therapeutic pressure by a second amount, or if a fifth condition relating to respiratory impairment is met while the therapeutic pressure is above the third threshold, the step is to decrease the therapeutic pressure by a fifth amount. A method comprising the step of changing the setting of a parameter for a first operating mode of the medical device, the parameter being at least one of the following: a first amount or a fourth amount, a second amount or a fifth amount, a first condition or a fourth condition, a second condition or a fifth condition, and a first threshold or a third threshold.

16. A program for causing a computer to perform each step of the method according to claim 15.

Images