JP6255558B1 - Respiratory assistance device, respiratory assistance method - Google Patents

Abstract

Provided is a respiratory assistance device that can comfortably provide respiratory assistance even during sleep. A breathing interface device that is attached to a user and delivers a gas; a gas temperature measuring unit that measures a gas temperature that is a gas temperature; a heating unit that heats a gas; and a heating unit Provided is a breathing assistance device including a temperature changing unit that controls to change a gas temperature. [Selection] Figure 1

Description

  The present invention relates to a ventilator, such as a respiratory assistance device.

  Automatic ventilators designed to connect to the user's (patient) airway to regulate or assist ventilation are widely used in the medical setting and are commonly referred to as ventilators. For example, a device designed to assist a patient's inspiration in synchrony with the patient's inspiratory effort (respiratory assistance device) is a type of ventilator. Among the respiratory assistance devices, there is a sleep apnea syndrome (SAS) as a disease that has been frequently applied in recent years. SAS occurs when airway muscles relax during sleep and the tongue base and soft palate fall, closing the airway. It is said that there are more than 3 million potential SAS patients in Japan. It is considered that the risk of cardiovascular disease in SAS patients is 2 to 4 times higher than that in healthy individuals, and SAS patients are more likely to have sleep disorders that exhibit severe sleepiness, resulting in traffic accidents. The risk is more than twice that of healthy people. For this type of patient, continuous positive pressure respiratory therapy (CPAP: Continuous Positive Airway) using a respiratory assistance device (refer to Patent Document 1) equipped with a blower that applies positive pressure (positive pressure) to the airway. Pressure) is valid. Such a breathing assistance device sends compressed air supplied from a blower to a patient's airway.

  In FIG. 11, the block diagram of the conventional respiratory assistance apparatus (CPAP) 301 is shown. The user 400 wears a respiratory interface device 410 such as a nasal mask that covers the nose. The breathing interface device 410 is fixed to the head by a fixing tool, and positive pressure is continuously applied to the airway during sleep, thereby preventing airway obstruction. The conventional breathing assistance device 301 includes a blower (blower) 340, a humidifying device 350, and the like, and gas is provided from the breathing interface device 410 to the airway of the user 400 through the breathing circuit 370. The gas is supplied with moisture from the humidifier 350 and heated by the heating unit 380 in order to prevent condensation, and then is supplied to the nose of the user 400. The basic structure of a general ventilator is the same, and how to control the temperature and humidity of the gas to be sent is an extremely important issue.

JP2015-142646A

Terumo Corporation, [online], [Search September 7, 2016], Internet (URL: http://www.terumo-taion.jp/health/sleep/01.html)

  However, respiratory assistance devices used for respiratory assistance have been developed to date with a focus on functions to eliminate airway obstruction, and little attention has been paid to improving comfort during use. It was.

  For example, a gas supplied by a respiratory assistance device that performs respiratory assistance for CPAP is generally provided at a constant temperature and humidity, that is, a gas temperature of 37 ° C. and a humidity of 100% relative humidity. This follows the temperature and humidity of the gas sent from the ventilator during tracheal intubation, and the user's comfort has not been sufficiently studied.

  FIG. 12 is a graph schematically showing the results of research by Uchiyama et al. Cited as Non-Patent Document 1. Shown in region 510 is a graph representing the relationship between time and deep body temperature. Shown in area 520 is a graph representing the relationship between time of day and the relative temperature of the back of the limb. A region 530 is a graph showing the relationship between time and ease of sleep. The larger the value on the vertical axis, the easier it is to sleep. Comparing the region 510 and the region 530, it can be seen that the ease of sleep increases when the internal temperature of the body (the deep body temperature) is low. It can be seen that during sleep, the deep body temperature is lower than when awakened, and in particular, the ease of sleep (see region 530) is peaked when the deep body temperature indicated by L1 to L3 is low. The human lung is thought to play a role like a radiator that releases heat inside the body to the external environment through breathing. Sending high-temperature gas to the respiratory tract during sleep is nothing more than preventing the body from trying to lower its temperature. Therefore, there is a high possibility that the conventional respiratory assistance device is preventing the user from taking good sleep. About half of the people who use respiratory assistance devices for respiratory assistance have stopped using the respiratory assistance devices within one year from the start of use, apart from the noise of the devices and poor usability. The difficulty in taking sleep is also considered to be the cause.

  In view of such circumstances, the present invention is intended to provide a respiratory assistance device that can comfortably provide respiratory assistance even during sleep.

  (1) The present invention is a breathing interface device that is attached to a user and delivers a gas, a gas temperature measuring unit that measures a gas temperature that is the temperature of the gas, and a heating unit that heats the gas. A breathing assistance device is provided that includes a temperature changing unit that changes the gas temperature by controlling the heating unit.

  According to the invention described in the above (1), since it has a temperature fluctuation part that fluctuates the gas temperature, it is optimal for the user not to supply gas at a constant temperature but to provide the user with occasional breathing assistance. The gas temperature can be changed to a suitable temperature. Therefore, according to this invention, there exists the outstanding effect of a user's comfort improvement.

  (2) In the present invention, when a predetermined time has elapsed from the start of operation of the respiratory assistance device, the temperature fluctuation unit controls the heating unit to lower the gas temperature. A respiratory assistance device according to (1) is provided.

  When breathing assistance is performed, it is more comfortable for the user to supply warm gas before and after the start of sleep, and the condition of passage through the nasal cavity is often improved. However, since the deep body temperature falls when falling asleep, it is desirable to reduce the temperature of the air supply gas. According to the invention described in the above (2), the gas is maintained at a constant temperature for a predetermined time from the start of operation of the breathing assistance device to improve the ventilation of the nasal cavity, and thereafter the heating unit is controlled. With this, the gas temperature is lowered and the user has an excellent effect of not preventing the lowering of the deep body temperature during sleep.

  (3) The present invention provides the respiratory assistance device according to (1) or (2), further including a humidifying device that humidifies the gas.

  According to the invention described in the above (3), since the respiratory assistance device further includes a humidifying device that humidifies the gas, an excellent effect that the respiratory assistance can be performed without excessively drying the airway and the nasal cavity. Play.

  (4) The present invention is characterized in that the humidifier includes a water storage section for storing water for humidification, and a porous hollow fiber section to which water of the water storage section is supplied. The respiratory assistance apparatus as described in 1. is provided.

  A humidifier provided in a conventional respiratory assistance device generates water vapor by boiling and evaporating water by heating with a heater. Therefore, there is a problem that it is difficult to freely control the temperature of the gas to be supplied. According to the humidifier described in (4) above, the hollow fiber can suck up water from the water storage portion by capillary action, and the surface of the hollow fiber is porous, so that water is transpiration through the fine pores. By doing so, the air supply gas can be humidified. By providing such a humidifier in the breathing assistance device, humidification without heater heating is possible, so that an excellent effect of facilitating control of the gas temperature is achieved.

  (5) The present invention includes a gas humidity measuring unit that measures a gas humidity that is the humidity of the gas, and a humidity changing unit that controls the humidifier to change the gas humidity to a predetermined humidity. The respiratory assistance device according to the above (3) or (4) is provided.

  According to the invention described in (5) above, since the respiratory assistance device includes the gas humidity measuring unit that measures the humidity of the gas and the humidity changing unit that changes the gas humidity to a predetermined humidity, the optimum humidity for the user There is a remarkable effect that the gas can be fed.

  (6) The present invention is characterized in that the humidity fluctuation unit controls the humidifier so that a predetermined water vapor supply amount is obtained from a correlation between the gas humidity and the gas temperature. A respiratory assistance device is provided.

  The amount of water vapor that can be contained in the air is determined by the temperature. Therefore, the optimum amount of water vapor for the user also changes depending on the temperature of the gas supplied by the respiratory assistance device. According to the invention described in (6) above, the humidity fluctuation unit can control the humidifier so that the predetermined water vapor supply amount is obtained from the correlation between the gas humidity and the gas temperature, so that the comfort of the user is improved. There is an excellent effect.

  (7) The present invention provides the respiratory assistance device according to (5) or (6) above, wherein the humidity changing unit includes a timer processing unit that controls the gas humidity over time.

  According to the invention described in (7) above, since the humidity changing unit has the timer processing unit that controls the gas humidity over time, the gas humidity can be controlled according to a preset timer program, and easily There is an effect of improving the comfort of the user.

  (8) The respiration according to any one of claims 1 to 7, wherein the temperature change unit includes a timer processing unit that controls the gas temperature with time. Provide auxiliary equipment.

  According to the invention described in (8) above, since the temperature variation unit has the timer processing unit that controls the gas temperature over time, the gas temperature can be controlled according to a preset timer program, and can be easily performed. There is an effect of improving the comfort of the user.

  (9) The present invention includes a biological information acquisition unit that acquires biological information of the user, and the humidity changing unit controls the humidifier so as to change the gas humidity based on the biological information. Provided is a respiratory assistance device according to any one of (5) to (7) above.

  According to the invention described in (9) above, since it is possible to supply gas having the optimum humidity for the user based on the biological information acquired by the biological information acquisition unit, the comfort of the user is improved. There is an excellent effect.

  (10) The present invention includes a biological information acquisition unit that acquires the user's biological information, and the temperature changing unit controls the heating unit to change the gas temperature based on the biological information. The respiratory assistance device according to any one of (1) to (9) is provided.

  According to the invention described in (10) above, the biometric information acquisition unit that acquires the biometric information of the user is further provided, and the temperature of the gas to be supplied can be changed based on the acquired information. It is possible to supply gas having an optimum temperature for the user, and an excellent effect of improving the comfort of the user is achieved.

  (11) In the present invention (9) or (10), the biological information acquisition unit includes a deep body temperature measurement unit that measures a deep body temperature that is a temperature of the user's deep body. A respiratory assistance device according to any one of the above.

  According to the invention described in (11) above, since it is possible to measure the deep body temperature, which is the temperature of the deep part of the living body of the user, the deep body temperature during sleep is measured, and the temperature fluctuation of the gas in accordance with the change There is an excellent effect that becomes possible.

  (12) The present invention is characterized in that the temperature fluctuation unit controls the heating unit to lower the gas temperature when the deep body temperature measured by the deep body temperature measurement unit is lowered. The respiratory assistance device according to (10) above is provided.

  In general, it is known that the deep body temperature falls during sleep, and there is a research result that it becomes easy to fall asleep when the fall of the deep body temperature is promoted. According to the invention described in (12) above, when the deep body temperature measured by the deep body temperature measurement unit is lowered, the heating unit can be controlled so as to lower the gas temperature to be supplied. When breathing assistance is performed, sleep is not disturbed, and an excellent effect of improving user comfort is achieved.

  (13) The present invention provides the respiratory assistance device according to (11) or (12), wherein the temperature fluctuation unit controls the gas temperature to be equal to or lower than the deep body temperature.

  According to the invention described in (13) above, since the temperature of the gas supplied by the respiratory assistance device can be controlled to be equal to or lower than the deep body temperature, the lowering of the deep body temperature can be promoted by the gas, so It has an excellent effect of facilitating.

  (14) In the present invention, the biological information acquisition unit includes a body surface temperature measurement unit that measures a body surface temperature, which is a temperature of the user's body surface, (9) to (13) A respiratory assistance device according to any of the above.

  It is known that the body surface temperature, which is the temperature of the body surface, rises conversely at the same time that the deep body temperature decreases during sleep. This is considered to be because heat is released from the body surface in order to lower the deep body temperature. According to the invention described in the above (14), it is possible to improve the comfort of the user and improve the sleep state by providing means for measuring the body surface temperature and reflecting the measurement result on the temperature of the gas to be supplied. It has an excellent effect of becoming.

  (15) In the present invention, when the body surface temperature measured by the body surface temperature measuring unit is increased, the temperature changing unit controls the heating unit so as to decrease the gas temperature. The respiratory assistance device according to (14) above, characterized in that:

  As described above, it is known that the body surface temperature, which is the temperature of the body surface, rises at the same time as the deep body temperature decreases during sleep. According to the invention described in (15) above, when the body surface temperature of the user measured by the body surface temperature measurement unit rises, the temperature fluctuation unit controls the heating unit so as to lower the gas temperature. By doing so, the user has an excellent effect that a therapeutic effect is high and a comfortable respiratory assistance device can be realized for the user.

  (16) The present invention further includes an outside air temperature measurement unit that measures an outside air temperature that is a temperature of the place where the user is present, and the temperature fluctuation unit controls the gas temperature based on the outside air temperature. Provided is the respiratory assistance device according to any one of (1) to (15) above.

  During sleep, humans are thought to control metabolic activities and others so that the best sleep environment is obtained when breathing at the temperature (outside air temperature) where the person is sleeping. In the conventional breathing assistance that sends the gas heated by the heater heating type humidifier attached to the breathing assistance device to the airway, it is sleeping while taking in excess heat energy, May be adversely affected. According to the invention described in (16) above, the outside air temperature measuring unit that measures the outside air temperature is provided, and the temperature of the gas supplied by the temperature fluctuation unit is determined based on the outside air temperature. There is an excellent effect that gas can be supplied.

  (17) In the present invention, when the outside air temperature is defined as Tout (the unit is Celsius temperature: ° C), the temperature variation unit changes the gas temperature from (Tout-1) ° C to (Tout-3) ° C. The respiratory assistance device according to the above (16), characterized by being controlled in between.

  If an excessively low temperature gas is supplied to the nasal cavity, the nasal congestion may occur. According to the invention described in the above (15), since the temperature fluctuation part controls the temperature of the gas to be fed between (Tout-1) ° C. and (Tout-3) ° C., the gas at a moderately low temperature It is possible to insufflate and improve the user's comfort and achieve both the effects of treatment and the excellent effect.

  (18) The present invention provides the biological information acquisition unit according to any one of (9) to (17), wherein the biological information acquisition unit includes a body motion measurement unit that measures the body motion of the user. A respiratory assistance device is provided.

  Human sleep states can be broadly divided into a deep sleep “non-REM sleep” state and a shallow sleep “REM sleep” state. It is known that body movements decrease in the “non-REM sleep” state, and body movements increase in the “REM sleep” state. Can be determined. According to the invention described in (18) above, since the respiratory assistance device can measure body movement by the body movement measuring unit and can supply gas having a temperature and humidity according to each sleep state, It has an excellent effect that a comfortable breathing assistance device can be realized.

  (19) The present invention includes a sleep depth determination unit that determines the sleep depth of the user from the body motion measured by the body motion measurement unit, and the gas temperature when the sleep depth increases. The respiratory assistance device according to (18) is provided, wherein the respiratory assistance device is lowered.

  In the “non-REM sleep” state, which is a so-called deep sleep, human body temperature decreases and breathing slows down. According to the invention described in (19) above, the respiratory assistance device includes the sleep depth determination unit that determines the depth of sleep of the user from the body movement, and shifts to a “non-REM sleep” state in which deep sleep is achieved. At this time, since the temperature of the gas can be lowered so as to lower the deep body temperature, there is an excellent effect that a breathing assistance device comfortable for the user can be realized.

(20) The present invention is a method of controlling a respiratory assistance device that delivers gas to a sleeping user , wherein the respiratory assistance device measures a gas temperature that is the temperature of the gas; The breathing assistance device includes a heating step for heating the gas, and the breathing assistance device includes a temperature fluctuation step for changing the gas temperature by controlling a heating unit, and the temperature by the breathing assistance device. In the respiratory assistance device, the step of changing the gas temperature is changed by changing the heating step according to a decrease in the deep body temperature that occurs autonomously in the body of the user during sleep. Provide a control method.

According to the invention of the control method for a respiratory assistance device that delivers gas to a sleeping user described in (20) above, the respiratory assistance device has a temperature variation step that varies the gas temperature. The breathing assistance device can lower the gas temperature by changing the heating step in accordance with the lowering of the deep body temperature that occurs autonomously in the user's body. Therefore, the breathing assistance device can change the gas temperature to an optimum temperature from time to time for the user, rather than simply supplying gas at a constant temperature. In particular, since the breathing assistance device can lower the gas temperature in accordance with the lowering of the deep body temperature at the time of falling asleep, there is an excellent effect of improving the comfort of the user.

  According to the present invention, since the breathing assistance device has the temperature fluctuation portion that varies the gas temperature, the breathing assistance is not simply supplying gas at a constant temperature, but is optimal for the user from time to time. The gas temperature can be changed to the temperature, and an excellent effect of improving the comfort of the user is achieved.

It is explanatory drawing of the respiratory assistance apparatus which concerns on 1st embodiment of this invention. It is a block diagram of the control apparatus which controls a respiratory assistance apparatus. It is a flowchart about temperature control of the gas to supply. It is a graph which shows the example of gas temperature control. It is explanatory drawing of the respiratory assistance apparatus which concerns on 2nd embodiment of this invention. It is a block diagram of the control apparatus which controls a respiratory assistance apparatus. It is a flowchart about temperature control and humidity control of gas to supply. It is explanatory drawing of the respiratory assistance apparatus which concerns on 3rd embodiment of this invention. (A) It is a block diagram of the control apparatus which controls a respiratory assistance apparatus. (B) It is a graph which shows the example of gas temperature control. It is a block diagram of the control apparatus concerning a modification. It is sectional drawing of the humidification apparatus which concerns on a modified example. It is explanatory drawing of the conventional respiratory assistance apparatus. It is a graph showing the relationship between time and deep body temperature (area 510), time and relative temperature with respect to the body of the back of the limb (area 520), and time and ease of sleep (area 530).

  Embodiments of the present invention will be described below with reference to the accompanying drawings. 1 to 10 are examples of embodiments for carrying out the invention, and in the drawings, parts denoted by the same reference numerals represent the same items. In addition, a part of the configuration is omitted as appropriate in each drawing to simplify the drawing. The size, shape, thickness, etc. of the members are exaggerated as appropriate.

  FIG. 1 is an explanatory view illustrating a respiratory assistance device 1 according to the first embodiment of the present invention. The respiratory assistance device 1 includes a main body 5, a humidifying device 50 for humidifying a gas to be supplied, a breathing circuit 70 including a conduit for transporting the gas to be supplied, and a heating for heating the gas in the breathing circuit. Unit 80, respiratory interface device 110 that is attached to the user and delivers gas, and deep body temperature measurement sensor 120 that detects the deep body temperature that is the temperature of the user's deep body. The respiratory interface device 110 is preferably a nasal mask or nasal prong. In order to prevent the pressure from increasing due to exhalation and making it difficult to exhale, it is desirable to provide a so-called relief valve that opens to the atmosphere when the pressure increases, at or near the breathing interface device 110.

  The main body 5 includes a blower (blower) 40 that supplies compressed gas, a flow rate measuring device 20 that measures the flow rate of the supplied gas, and a control device 10 that controls the flow rate, pressure, and temperature of the gas. The blower (blower) 40 sucks and compresses outside air from the intake port 30 and sends it to the breathing circuit 70. At this time, the flow rate of the gas to be fed is measured by the flow rate measuring device 20, and the control device 10 performs control so that the prescription pressure prescribed by the doctor is obtained. It is desirable to provide a pressure gauge that measures the pressure of the gas to be supplied.

  A breathing interface device 110 is connected to the breathing circuit 70, and positive pressure gas is applied from the breathing interface device 110 to the nasal cavity of the user 100. The breathing circuit 70 or the breathing interface device 110 includes a gas temperature sensor 105 that detects a gas temperature that is a gas temperature in the vicinity of the breathing interface device 110. In addition, a heating unit 80 is provided in at least a part of the breathing circuit 70, and the gas temperature is controlled by the control device 10 controlling the heater power supply 90.

  The humidifier 50 is connected to the main body 5 or the breathing circuit 70 and humidifies the gas sent to the user. The humidifier 50 includes a water storage part 55 that stores water for humidification, and a porous hollow fiber part 60 that is supplied with water from the water storage part. The porous hollow fiber portion 60 is inserted into the breathing circuit 70 and humidifies the gas in the breathing circuit 70 by vaporizing water vapor.

  The deep body temperature measurement sensor 120 may be a heat flow compensation type or a method including a plurality of heat flow sensors.

  FIG. 2 shows a configuration diagram of the control device 10. The control device 10 includes a biometric information acquisition unit 140 that acquires biometric information of the user, a temperature change unit 130 that changes the gas temperature by controlling the heating unit 80, and a gas temperature measurement unit 180 that measures the gas temperature. Have The biological information acquisition unit 140 includes a deep body temperature measurement unit 160 that measures the deep body temperature (see FIG. 1). The temperature fluctuation unit 130 is connected to the heater power supply 90, and the deep body temperature measurement unit 160 is connected to the deep body temperature measurement sensor 120 (see FIG. 1). As will be described later, the temperature changing unit 130 controls the temperature of the heating unit 80 to change the gas temperature based on the deep body temperature, which is biological information. The gas temperature measurement unit 180 is connected to the gas temperature sensor 105 and measures the temperature of the gas (see FIG. 1). At this time, the control device 10 desirably performs feedback control (for example, PID control) of the heating unit 80 based on the temperature of the gas obtained by the gas temperature measurement unit 180.

  The control device 10 includes a CPU, a RAM, a ROM, and the like, and executes various controls. The CPU is a so-called central processing unit, and executes various programs to realize various functions. The RAM is used as a work area and a storage area of the CPU, and the ROM stores an operating system and programs executed by the CPU.

  FIG. 3A shows a flowchart of the temperature control of the gas temperature performed by the control device 10.

  First, when the power of the breathing assistance device 1 is turned on, the blower (blower) 40 starts operation and starts breathing assistance (see FIG. 1). Although not specifically shown, when the power is turned on, a set value (such as a prescription pressure) immediately before the power is turned off last time is automatically reflected.

  A timer function (not shown) for measuring the operation time is started from the start of operation, and the gas temperature is maintained at a predetermined temperature, for example, 37 ° C. for a predetermined time, for example, 30 minutes (step S1-10). This is because it is more comfortable for the user to send a relatively warm gas during sleep because the passage of the nasal cavity is better. It is desirable that the predetermined time and the predetermined temperature can be appropriately changed by the user.

  When a user enters a sleep state after a lapse of a predetermined time from the start of operation of the respiratory assistance device 1, the deep body temperature of the user, which is detected by the deep body temperature measurement sensor 120 and measured by the deep body temperature measurement unit 160, decreases. start. Accordingly, the temperature fluctuation unit 130 of the control device 10 controls the heater power supply 90 to lower the temperature of the heating unit 80, thereby lowering the gas temperature to a predetermined target temperature (step S1-20). This target temperature is lower than the deep body temperature, preferably the same as the outside air temperature, or 1 to 3 ° C. lower than the outside air temperature. When the target temperature is substantially equal to the outside air temperature, the temperature changing unit 130 may reduce the power supplied to the heater power supply 90 or make it zero.

  In order to make the gas cooler than the outside air temperature, it is desirable to provide a cooling mechanism. The cooling mechanism may be generally used for gas cooling, and may be cooled by removing heat of vaporization from gas using a refrigerant and a compressor as in a normal refrigerator, or using a Peltier element. Good. Cooling using the humidifier 50 itself is also conceivable.

  It is desirable that the target temperature can be changed by the user during operation.

  That is, the control device 10 controls the heating unit 80 so as to lower the gas temperature based on the biological information of the deep body temperature. In general, during sleep, the human deep body temperature decreases until just before waking, so when the deep body temperature measured by the deep body temperature measurement unit 160 decreases, the control device 10 warms so that the gas temperature decreases. It is desirable to control the unit 80. At this time, it is desirable that the control device 10 performs feedback control of the heating unit 80 so as to reach the target temperature using the gas temperature detected by the gas temperature sensor 105 and measured by the gas temperature measuring unit 180.

  Thereafter, the control device 10 keeps the gas temperature at the target temperature and continues the breathing assistance until the user is awakened and the operation is stopped by turning off the power of the breathing assistance device 1 (in step S1-30). In the case of NO). When the operation of the respiratory assistance device 1 is turned off and the operation is stopped, the control of the gas temperature is also stopped at the same time (in the case of YES at step S1-30).

  With the above operation, the respiratory assistance device 1 can control the heating unit 80 so as to lower the temperature of the gas to be delivered without hindering the lowering of the deep body temperature during sleep, so that the respiratory assistance is performed. There is an excellent effect of improving user comfort without disturbing sleep. Of course, even artificial respiration improves sleep comfort.

  FIG. 3B is a graph showing a modified example of the gas temperature control.

  FIG. 3B (a) shows an example in which the gas temperature is changed by the temperature changing unit 130 (see FIG. 2) in accordance with a timer (not shown) provided in the respiratory assistance device 1 regardless of biological information. The gas temperature is maintained at, for example, 37 ° C. for 30 minutes from the start of operation indicated by the period 610, and the gas temperature is decreased by 3 ° C. in the period 620. Thereafter, the gas temperature is maintained at 34 ° C. for 2 hours and 30 minutes (period 630). Thereafter, the gas temperature is further lowered by 3 ° C. (period 640), and then the gas temperature is maintained at 31 degrees for 2 hours (period 650). In the period 660 toward the awakening in time, the temperature is increased by 6 ° C. and then maintained at 37 ° C. (period 670). By performing such a timer operation, it is possible to easily realize the comfort during sleep for the user.

  FIG. 3B (b) shows a case where the deep body temperature is measured, the target temperature is lowered in accordance with the fall, and the gas temperature is lowered. In this modified example, for 30 minutes from the start of operation, the gas temperature is maintained at 37 ° C., for example, and then detected by the deep body temperature measurement sensor 120 and in accordance with the decrease in the deep body temperature measured by the deep body temperature measurement unit 160, The gas temperature is lowered.

  Specifically, the deep body temperature is measured at predetermined time intervals, and the target temperature is determined as needed according to the measurement (see FIG. 3A). Referring to FIG. 3B (b), for example, on the basis of a temperature 34 ° C. that is 2 ° C. lower than the average human body temperature of 36 ° C., the time course of the deep body temperature is multiplied by a predetermined coefficient, for example 2.0. The target temperature is changed by the specified temperature. In other words, during the period 740, the gas temperature is decreased by 3 ° C. following the decrease in the deep body temperature by 1.5 ° C., and during the period 750 where there is no change in the deep body temperature, the gas temperature is maintained at 31 ° C. Determine the temperature. In addition, in order to prevent the nasal cavity from being abruptly stimulated by fluctuations in gas temperature and hindering the user's deep sleep, in order to change the gas temperature smoothly, the temperature change determined by the deep body temperature and time is small and the time change is a smooth function The target temperature may be determined by Of course, a lookup table of the deep body temperature and the target temperature may be prepared in advance in the temperature fluctuation unit 130, and the target temperature may be determined according to the deep body temperature measured by the deep body temperature measurement unit 160.

  In this modified embodiment, the increase in the deep body temperature that often occurs during awakening is not reflected in the gas temperature.

  In addition, it cannot be overemphasized that gas temperature control which concerns on the modified example given to above-mentioned FIG. 3B (a)-FIG. 3B (b) is applicable also in other embodiment.

  FIG. 4 is an explanatory diagram of the respiratory assistance device 1 according to the second embodiment of the present invention. The difference from the first embodiment is a gas humidity sensor 95 that detects the humidity of the gas, and a humidity adjustment unit 65 that adjusts the amount of water vapor supplied from the humidifier 50 to vary the humidity.

  In addition, as a specific mechanism of the humidity adjusting unit 65 for adjusting the humidity, the amount of water supplied to the porous hollow fiber unit 60 may be adjusted by an electromagnetic valve. And the amount of water vapor generated may be increased or decreased by adjusting the amount of heating.

  In a conventional breathing assistance device used for breathing assistance, a gas having a relative humidity of 100% is supplied from the airway, and whether such gas is comfortable for the user depends on circumstances. For example, a user who receives CPAP therapy is supplied through a nasal cavity that can give moisture to the gas, and has the ability to humidify by himself. Therefore, in the second embodiment of the present invention, the user's comfortable sleep is promoted by maintaining the humidity of the gas to be supplied at a target humidity, for example, any value between 60% and 80% relative humidity. It is desirable that the user can change the target humidity during operation of the breathing assistance device 1.

  The block diagram of the control apparatus 10 in the respiratory assistance apparatus 1 which concerns on FIG. 5 at 2nd embodiment of this invention is shown. In addition to the control device 10 of the first embodiment, the control device 10 further includes a humidity changing unit 150 that changes the gas humidity to a predetermined humidity and a gas humidity measuring unit 185 that measures the humidity of the gas.

  That is, the breathing assistance device 1 is provided with a gas humidity sensor 95 that detects the humidity of the gas in the breathing circuit 70, and the control device 10 is provided with a gas humidity measuring unit 185 that measures the humidity of the gas (FIG. 4). reference). The control device 10 further includes a humidity changing unit 150 that changes the gas humidity to a predetermined humidity, and the humidity changing unit 150 controls the humidity adjusting unit 65. The gas humidity sensor 95 is connected to the gas humidity measuring unit 185, and it is desirable that the humidity changing unit 150 feedback-controls the gas humidity based on the measured gas humidity.

  FIG. 6A shows a flowchart of the control of gas temperature and gas humidity performed by the control device 10. The difference from the first embodiment shown in FIG. 3A is that, in (Step S2-20), the humidity changing unit 150 of the control device 10 sets the target gas temperature as the depth body temperature decreases after a predetermined time has elapsed. After the operation to lower the temperature, in (Step S2-30), the operation of maintaining the gas humidity at a predetermined humidity is performed. This order may be reversed, and (Step S2-30) may be performed simultaneously with (before or after) (Step S2-10).

  In addition, although the aspect which maintains humidity constant was demonstrated here, in order to improve a user's comfort, you may control the humidification apparatus 50 so that gas humidity may be fluctuate | varied based on biometric information. Specifically, the relative humidity may be increased or decreased according to the fluctuation of the deep body temperature. For example, when deep body temperature falls, sweat may increase due to the release of heat from the body surface, so set the target humidity high to prevent excessive loss of moisture from the body Control may be performed by the humidity changing unit 150 (see FIG. 6B). Conversely, when the deep body temperature rises, the humidity may be lowered.

  Further, the humidifier 50 may be controlled so as to obtain a predetermined water vapor supply amount from the correlation between the gas humidity and the gas temperature.

  In FIG. 7, explanatory drawing of the respiratory assistance apparatus 1 which concerns on 3rd embodiment of this invention is shown. The difference from the second embodiment is an outside air temperature measurement sensor 45 that detects the outside air temperature Tout (unit is Celsius temperature: ° C.) that is the temperature of the place where the user is.

  FIG. 8A shows a configuration diagram of the control device 10 in the respiratory assistance device 1 according to the third embodiment. The control device 10 further includes an outside air temperature measurement unit 170 that is connected to the outside air temperature measurement sensor 45 and measures the outside air temperature. The temperature fluctuation unit 130 controls the gas temperature between (Tout-1) ° C. and (Tout-3) ° C. as the target temperature.

  As described above, in the conventional breathing assistance device used for breathing assistance, the temperature of the supplied gas is maintained at 37 ° C. Since the deep body temperature falls during sleep, and when the deep body temperature is lowered, it is easy to fall asleep. Therefore, in order for the user to take a more comfortable sleep, the gas temperature of the gas supplied from the respiratory assistance device 1 is the outside air temperature. This is because it is considered to be preferable that the temperature is the same temperature as that of the outside air temperature Tout or lower by about 1 ° C. to 3 ° C., for example.

  FIG. 8B shows a case where temperature control is performed in which the deep body temperature is measured, the target temperature is varied in accordance with the variation, and the gas temperature is varied by the temperature variation unit 130. In this modified embodiment, gas is supplied at a temperature lower than the outside air temperature. That is, for example, it is assumed that the outside air temperature measured by the outside air temperature measuring unit 170 is constant at 25 ° C. For the first 30 minutes, the gas temperature is maintained at 37 ° C. as in the above modified embodiment. Subsequently, in the period 820, the gas temperature is decreased as the deep body temperature decreases, and in the period 830, the gas temperature is maintained in accordance with the fact that the deep body temperature does not vary. After that, in the period 840, the gas temperature is lowered again as the deep body temperature falls, and the gas temperature is maintained at 23 ° C., which is 2 ° C. lower than the outside air temperature, for the next one hour as the deep body temperature does not change (Period 850). In the subsequent period 860, the gas temperature is increased by 2 ° C. as the deep body temperature increases, and similarly, the gas temperature is controlled in accordance with the fluctuation of the deep body temperature. Note that the gas temperature may be determined in consideration of fluctuations in the outside air temperature. By performing such gas temperature control, breathing assistance comfortable for the user becomes possible.

  The cooling mechanism that lowers the gas below the outside air temperature may be generally used for gas cooling, and uses a refrigerant and a compressor like a normal refrigerator to cool the gas by taking the heat of vaporization. Alternatively, a Peltier element may be used. Of course, cooling using the humidifier 50 itself is also conceivable. The gas temperature may be controlled so as to fluctuate in accordance with changes in the deep body temperature.

  The respiratory assistance device according to the present invention is not limited to the above-described embodiment, and various changes can be made without departing from the scope of the present invention.

  For example, as shown in FIG. 9A, a modified embodiment in which the temperature fluctuation unit 130 included in the respiratory assistance device 1 includes a timer processing unit 190 is conceivable. The timer processing unit 190 controls the gas temperature over time.

  FIG. 9B shows an example in which the gas temperature is changed by the timer processing unit 190. For 30 minutes after starting operation, the temperature fluctuation unit 130 keeps the gas temperature at 37 ° C., which is slightly higher than the body temperature (period 930). Subsequently, the timer processing unit 190 recognizes that 30 minutes have elapsed, and causes the temperature fluctuation unit 130 to lower the gas temperature to 25 ° C. over 30 minutes (period 940). Then, the timer processing unit 190 recognizes that the period 940 has elapsed, and controls the heating unit 80 to maintain the gas temperature at 25 ° C. for the next one hour (period 950). Thereafter, the timer processing unit 190 operates in the same manner, so that the gas temperature is controlled as time elapses, and the user can enjoy the CPAP therapy comfortably and effectively.

  The respiratory assistance device 1 has, for example, a plurality of operation modes such as a timer mode for controlling the gas temperature over time as described above and a biological information mode for changing the gas temperature based on the biological information. A selection processing function that allows the user to select one of the modes may be provided. In the timer mode, in addition to a plurality of preset sequences, that is, the sequence shown in FIG. 9B, for example, a sequence for decreasing the gas temperature at a constant rate over 8 hours, etc. is provided, and the user selects It may be possible.

  Further, for example, in the second embodiment and the third embodiment, a modified example in which the humidity changing unit 150 includes the timer processing unit 190 is also conceivable (see FIGS. 5 and 8). The timer processing unit 190 controls the gas humidity over time.

  Further, for example, the humidifier may be a conventional tank humidifier or a system as shown in FIG. FIG. 10 is a sectional view of a humidifier 210 according to a modified embodiment of the present invention. The humidifier 210 is connected to a breathing circuit 70 of a breathing assistance device that regulates or assists ventilation in a user's respiratory apparatus, as in the case of a conventional humidifier, so that moisture is supplied to the supplied gas in the form of particulates or water vapor. give. The humidifier 210 is disposed between the blower (blower) side pipe 290 and the breathing circuit side pipe 295, and generates a liquid container 280 that contains a liquid containing at least water, and mist droplets that are fine liquid droplets of the liquid. A mist droplet generating means 270 that holds the water droplets and a water retention member 220 that holds at least a part of the mist droplets. In this modified embodiment, the mist droplet generating means 270 generates mist droplets by ultrasonic vibration as will be described later.

  The mist droplet generating means 270 has ultrasonic wave generating means for generating mist droplets by exciting the liquid. That is, in the humidifying apparatus according to this modified embodiment, the mist generation means 270 is an ultrasonic mist generation means using a so-called cavitation effect that generates bubbles on the liquid surface by vibration energy from the ultrasonic vibrator. , A housing 255, an ultrasonic transducer 260, and an ultrasonic transmission material 250. The ultrasonic transmission material 250 is, for example, water. Since the water that is the ultrasonic transmission material 250 held by the housing 255 has a large specific heat, the temperature including the water 240 that is in contact with the housing 255 and the housing 225 does not easily rise, and the humidifier 210 as a whole is used for a long time. It is suitable for. The mist generation means 270 and the liquid container 280 are in close contact with a boundary 285 with a substance that can easily transmit ultrasonic waves, such as non-volatile oil.

  The ultrasonic transducer 260 is controlled by a controller (not shown) included in the control device 10. The controller includes a CPU, RAM, ROM and the like for controlling the entire humidifier 10. The CPU is a so-called central processing unit, and executes various programs to realize various functions. The RAM is used as a work area and a storage area of the CPU, and the ROM stores an operating system and programs executed by the CPU. The controller has a function of monitoring the depth temperature, gas temperature, gas flow rate, etc., and performing feedback control (PID control, etc.) of the heater of the mist droplet heating means 230 to adjust to a predetermined temperature and humidity. It is desirable. Further, it is desirable to issue a warning when the water 240 in the liquid container 280 becomes less than a predetermined amount of water.

  The amount of mist generated by the mist generating means 270 is controlled by the controller. For example, when the amplitude of the AC voltage applied to the ultrasonic transducer 260 is increased, the amplitude of the vibration of the ultrasonic transducer 260 is increased, and the amount of generated mist droplets is increased. The liquid container 280 is desirably removable from the housing 225. It is desirable that the mist generation means 270 is also removable from the liquid container 280.

  The humidifier 210 has a flow path through which the gas to be sent flows. The flow path is closed by the water retention member 220, and the liquid container 280 and the mist droplet generation means 270 are disposed on the blower (blower) 40 side. The water retaining member 220 isolates the upstream side from the downstream side and the downstream side from the user side. Specifically, the water retaining member 220 is cylindrical and has a bottom. The opening side of the tube is joined to the inner peripheral surface of the housing 225 to block the flow path. In order to reduce the resistance when the gas passes through the water retaining member 220, it is desirable to increase the ventilation area. Therefore, it is preferable to provide a gap between the cylindrical water retaining member 220 and the inner peripheral surface of the housing 225 to ensure a gap. Instead of providing the spacer, the diameter of the cylinder of the water retaining member 220 may be sufficiently smaller than the inner peripheral diameter of the housing 225 to ensure the gap. It is desirable that the water retaining member 220 is a non-woven fabric having water absorption and can be replaced. The material of the nonwoven fabric constituting the water retention member 220 is, for example, polypropylene, and it is desirable to perform a surfactant treatment, a fluorine gas treatment, a sulfonation treatment, an acrylic acid graft treatment, a plasma discharge treatment, etc. in order to make it hydrophilic.

  The water retaining member 220 is installed in the housing 225, and a mist droplet heating means 230 that heats the mist droplets and vaporizes them into water vapor is disposed inside the water retaining member 220, that is, on the liquid container 280 side. The mist droplet heating means 230 is a resistance heater composed of, for example, a nichrome wire, and is connected to a power source (not shown), and controls power and temperature and humidity by a controller based on gas temperature and the like. Although the water retaining member 220 blocks the mist, the gas containing water vapor can pass through the water retaining member 220.

  Next, the operation of the humidifier according to the above-described modified embodiment will be described with reference to FIG.

  The dried gas is supplied from the blower (blower) side pipe 290 to the humidifier 210. It is the role of the humidifier 210 to add moisture to this gas, but humidification is performed by the following two methods.

  (1) Mist droplets generated on the surface of the liquid container 280 are vaporized by the mist droplet heating means 230 to become water vapor. The vibration energy of ultrasonic waves generated by the ultrasonic vibrator 260 is transmitted to the water surface of the liquid container 280, and fine mist droplets are generated by weakening the surface tension of a part of the water surface. Since the mist droplet is a minute droplet, it has a larger surface area than the volume and is easy to vaporize. Further, when the mist reaches the vicinity of the mist heating means 230, the temperature is high and the saturated vapor pressure is increased, so that vaporization is further facilitated. The vapor generated by vaporization humidifies the dried gas as a result.

  (2) When the mist generated on the surface of the liquid container 280 reaches the water retention member 220, it adheres to the water retention member 220. Since the water retaining member 220 has water absorption, the water adhering to the water retaining member is retained as liquid water. The water vapor pressure of the gas sent from the blower (blower) side pipe 290 is further increased and humidified by the water held in the water holding member 220 when passing through the vicinity of the water holding member 220.

  As described above, the humidifier 210 according to the modified embodiment described above can humidify by generating water vapor with an energy amount smaller than that of vaporization by normal boiling. In addition, since a large amount of water vapor can be generated without boiling the stored water 240, there is an excellent effect that the humidity can be controlled independently of the temperature without excessively increasing the temperature of the gas. Further, since the gas to be sent is filtered by the water retention member 220, the water retention member 220 has an effect that it plays the role of a bacterial filter simultaneously with humidification.

  As another modified embodiment, it is conceivable to change the gas temperature based on the body surface temperature instead of changing the gas temperature based on the deep body temperature. FIG. 12B is a graph showing the relationship between time and “relative temperature with respect to the body of the back of the limb”. “Relative temperature to the body of the back of the limb” is defined as the skin temperature of the back of the limb, minus the skin temperature under the collarbone at the base of the neck (close to the temperature of the trunk or trunk). . If the above-mentioned “relative temperature with respect to the body of the back of the limb” is represented as the body surface temperature, comparing FIG. 12B and FIG. 12C shows that there is a correlation between the body surface temperature and ease of sleep. That is, when the body surface temperature increases, it becomes easy to sleep, and conversely, when the body surface temperature decreases, it becomes difficult to sleep. This is considered to reflect that the human body increases heat release from the skin to lower the deep body temperature and suppresses heat release from the skin to increase the deep body temperature. Therefore, if the body surface temperature is measured in this manner, a respiratory assistance device capable of controlling the gas temperature based on the fluctuation of the deep body temperature can be realized without preparing a special deep body temperature sensor. There is an effect that it is possible to sleep more comfortably in the assistance.

  Specifically, in FIG. 1, the deep body temperature sensor 120 is read as a body surface temperature sensor, and in FIG. 2, the deep body temperature measurement unit 160 measures the body surface temperature, which is the temperature of the user's body surface. A configuration that replaces the part is desirable. That is, the biological information acquisition unit 140 includes a body surface temperature measurement unit that measures the body surface temperature, which is the temperature of the user's body surface, and the temperature variation unit 130 measures the body surface temperature measured by the body surface temperature measurement unit. When the temperature rises, the heating unit 80 is controlled to lower the gas temperature.

  As another modified embodiment, it is conceivable that an acceleration sensor for detecting the user's body movement is attached to the user to catch the body movement, and the gas temperature is changed based on the information.

  During sleep, humans are in a so-called shallow sleep, that is, “REM sleep” state when body motion is large, and in a so-called deep sleep, that is, “non-REM sleep” state, when body motion is small. The control device 10 of the respiratory assistance device 1 determines the depth of sleep of the user from the body movement measurement unit that measures body movement from the body movement information detected by the acceleration sensor and the body movement measured by the body movement measurement unit. A sleep depth determination unit for determination is provided. And when the depth of sleep deepens, it is possible that the temperature fluctuation | variation part 130 reduces gas temperature.

  The respiratory assistance device 1 according to the aspect described above has a remarkably excellent effect of enabling more comfortable sleep in the respiratory assistance.

  It goes without saying that the modified examples described above can be applied to all the embodiments and modified examples described in this specification.

DESCRIPTION OF SYMBOLS 1 Breathing assistance apparatus 5 Main body 10 Control apparatus 20 Flow measurement apparatus 30 Inlet 40 Blower (blower)
45 Air temperature measurement sensor 50 Humidifying device 55 Water storage unit 60 Porous hollow fiber unit 65 Humidity adjustment unit 70 Breathing circuit 80 Heating unit 90 Heater power supply 95 Gas humidity sensor 100 User 105 Gas temperature sensor 110 Respiratory interface device 120 Deep body temperature Measurement Sensor 130 Temperature Fluctuation Unit 140 Biometric Information Acquisition Unit 150 Humidity Fluctuation Unit 160 Deep Body Temperature Measurement Unit 170 External Air Temperature Measurement Unit 180 Gas Temperature Measurement Unit 185 Gas Humidity Measurement Unit 190 Timer Processing Unit 210 Humidifier 220 Water Retention Member 225 Case 230 Fog Drop heating means 240 Water 250 Ultrasonic transmitting substance 255 Case 260 Ultrasonic vibrator 270 Mist drop generating means 280 Liquid container 285 Boundary 290 Blower (blower) side piping 301 Conventional respiratory assist device 301
305 Main body 310 Control device 320 Flow rate measuring device 330 Inlet 340 Blower (blower)
350 Humidifier 355 Water storage unit 360 Heater power supply 365 Heating unit 370 Breathing circuit 380 Heating unit 390 Heater power supply 395 Gas temperature sensor 400 User 410 Respiration interface device

Claims (21)

A respiratory interface device that is worn by the user during sleep and delivers gas;
A gas temperature measuring unit for measuring a gas temperature which is the temperature of the gas;
A heating section for heating the gas;
A temperature variation unit that varies the gas temperature by controlling the heating unit;
The temperature fluctuation unit controls the heating unit to lower the gas temperature in accordance with a decrease in the deep body temperature that occurs autonomously in the user's body during sleep. apparatus. During the operation period, the temperature fluctuation part
A gas temperature lowering period for lowering the gas temperature;
A gas temperature maintenance period for maintaining the gas temperature;
The respiratory assistance device according to claim 1, further comprising: a gas temperature increase period for increasing the gas temperature.   The said temperature fluctuation | variation part performs the control of the said heating part, and falls the said gas temperature, when predetermined time passes since the driving | operation start of the said respiratory assistance apparatus, The Claim 1 or Claim 2 characterized by the above-mentioned. Breathing assistance device.   The respiratory assistance device according to any one of claims 1 to 3, further comprising a humidifier that humidifies the gas. The humidifier is
A water reservoir for storing water for humidification;
A porous hollow fiber part to which water of the water storage part is supplied;
The respiratory assistance device according to claim 4, further comprising: A gas humidity measuring unit for measuring a gas humidity which is a humidity of the gas;
The respiratory assistance device according to claim 4 or 5, further comprising a humidity changing unit that controls the humidifier to change the gas humidity to a predetermined humidity.   The respiratory assistance device according to claim 6, wherein the humidity changing unit controls the humidifier so that a predetermined water vapor supply amount is obtained based on a correlation between the gas humidity and the gas temperature.   The respiratory assistance device according to claim 6 or 7, wherein the humidity changing unit includes a timer processing unit that controls the gas humidity over time.   The respiratory assistance device according to any one of claims 1 to 8, wherein the temperature changing unit includes a timer processing unit that controls the gas temperature over time. A biometric information acquisition unit for acquiring the biometric information of the user;
The said humidity fluctuation | variation part controls the said humidifier so that the said gas humidity is fluctuated based on the said biometric information, The Claim 6 characterized by the above-mentioned. Respiratory device. A biometric information acquisition unit for acquiring the biometric information of the user;
The said temperature fluctuation | variation part controls the said heating part so that the said gas temperature may be fluctuate | varied based on the said biometric information, The Claim 1 characterized by the above-mentioned. Breathing assistance device.   The respiratory assistance device according to claim 10 or 11, wherein the biometric information acquisition unit includes a deep body temperature measurement unit that measures a deep body temperature that is a temperature of the deep body of the user.   The said temperature fluctuation | variation part controls the said heating part so that the said gas temperature may be lowered | hung when the said deep body temperature measured by the said deep body temperature measurement part falls. Breathing assistance device.   The respiratory assistance device according to claim 12 or 13, wherein the temperature fluctuation unit controls the gas temperature to be equal to or lower than the deep body temperature.   The said biological information acquisition part has a body surface temperature measurement part which measures the body surface temperature which is the temperature of the said user's body surface, It is any one of Claims 10-14 characterized by the above-mentioned. The respiratory assistance device described.   The temperature variation unit controls the heating unit to decrease the gas temperature when the body surface temperature measured by the body surface temperature measurement unit increases. A respiratory assistance device according to 1.   It further comprises an outside air temperature measurement unit that measures the outside air temperature that is the temperature of the place where the user is located, and the temperature fluctuation unit controls the heating unit based on the outside air temperature, the gas temperature, The respiratory assistance device according to any one of claims 1 to 16, wherein the gas temperature is controlled.   When the outside air temperature is defined as Tout (unit is Celsius temperature: ° C), the temperature changing unit controls the gas temperature between (Tout-1) ° C and (Tout-3) ° C. The respiratory assistance device according to claim 17.   The respiratory assistance device according to any one of claims 10 to 18, wherein the biological information acquisition unit includes a body motion measurement unit that measures body motion of the user. From the body motion detected by the body motion measurement unit, a sleep depth determination unit that determines the depth of sleep of the user,
The respiratory assistance device according to claim 19, wherein when the depth of sleep increases, the temperature changing unit controls the heating unit to lower the gas temperature. A method of controlling a respiratory assistance device that delivers gas to a sleeping user ,
A gas temperature measuring step in which the respiratory assistance device measures a gas temperature which is a temperature of the gas;
A heating step in which the respiratory assistance device heats the gas;
The respiratory assistance device includes a temperature variation step of varying the gas temperature by controlling a heating unit,
The temperature change step by the breathing assistance device may be configured to change the heating step to lower the gas temperature in accordance with a lowering of the deep body temperature that occurs autonomously in the user's body during sleep. A control method of a respiratory assistance device, which is characterized.

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