WO2021022785A1 - Système multifonctionnel de production d'oxygène basé sur une régulation coopérative de la fréquence respiratoire et de la valeur cible d'oxygène dans le sang - Google Patents

Système multifonctionnel de production d'oxygène basé sur une régulation coopérative de la fréquence respiratoire et de la valeur cible d'oxygène dans le sang Download PDF

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WO2021022785A1
WO2021022785A1 PCT/CN2020/070907 CN2020070907W WO2021022785A1 WO 2021022785 A1 WO2021022785 A1 WO 2021022785A1 CN 2020070907 W CN2020070907 W CN 2020070907W WO 2021022785 A1 WO2021022785 A1 WO 2021022785A1
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oxygen
output
blood oxygen
patient
target blood
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PCT/CN2020/070907
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English (en)
Chinese (zh)
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阮雪红
陈旭良
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西安汇智医疗集团有限公司
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Priority claimed from CN201910715675.7A external-priority patent/CN110269988A/zh
Priority claimed from CN201911092478.0A external-priority patent/CN110639101A/zh
Application filed by 西安汇智医疗集团有限公司 filed Critical 西安汇智医疗集团有限公司
Publication of WO2021022785A1 publication Critical patent/WO2021022785A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/42—Rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature

Definitions

  • the embodiment of the present disclosure relates to a multifunctional oxygen output system based on the coordinated control of respiratory frequency and target blood oxygen value, and belongs to a clinically used medical device.
  • Medical oxygen output control equipment is a necessary medical device for oxygen therapy in medical institutions.
  • the commonly used oxygen therapy equipment in medical institutions is an oxygen inhaler.
  • many patients with respiratory diseases need nebulized inhalation treatment during oxygen therapy, and medical staff need to use nebulizing equipment (oxygen jet nebulizing equipment is commonly used).
  • oxygen therapy and atomization therapy the two devices are used alternately, which not only increases the workload of medical staff, but also increases the cost of purchasing and maintaining the two devices in the hospital.
  • the existing oxygen therapy equipment and oxygen jet atomization equipment have a single control method for oxygen output.
  • the medical staff realizes oxygen output control after setting the output flow value.
  • the patient s blood oxygen saturation value is lacking (in other places in this article).
  • blood oxygen level or blood oxygen saturation also known as blood oxygen level or blood oxygen saturation
  • the dynamic monitoring of physiological parameters such as respiratory frequency
  • the dynamic adjustment of oxygen output cannot be achieved according to changes in the patient's physiological parameters.
  • BTS British Thoracic Society
  • Oxygen therapy must have a clear target blood oxygen saturation (that is, a clear treatment goal), and the patient's blood oxygen saturation must be dynamically monitored and maintained during oxygen delivery.
  • Respiration rate is also an important diagnostic basis in clinical diagnosis: fast breathing (refers to respiratory rate exceeding 24 beats/min), which is seen in fever, pain, anemia, hyperthyroidism and heart failure, etc.; slow breathing (refers to respiratory rate Less than 12 beats/min), seen in overdose of anesthetics or sedatives and increased intracranial pressure; respiratory rate with changes in breathing depth, shallow and rapid breathing, seen in respiratory muscle paralysis, severe tympanum, ascites, obesity, etc., and lung diseases (Such as pneumonia, pleurisy, pleural effusion and pneumothorax, etc.).
  • the purpose of the embodiments of the present disclosure includes, for example, providing a multifunctional oxygen output system based on the coordinated control of the respiratory rate and the target blood oxygen level, so as to overcome the above-mentioned shortcomings of the existing oxygen output devices.
  • the multifunctional oxygen output system based on the coordinated control of respiratory frequency and target blood oxygen value proposed by the embodiments of the present disclosure is mainly composed of, for example, a control module, a multi-parameter monitoring module, an electronic flow valve, a pneumatic steering switch, a human-computer interaction interface, and communication Module composition.
  • the control module is an integrated circuit developed based on the core processor, including signal processing module, power management module, storage module and other modules.
  • the core processor can use Central Processing Unit/Processor (CPU), Microcontroller Unit, MCU) or programmable logic controller (Programmable Logic Controller, PLC).
  • the control module can be connected with a multi-parameter monitoring module, an electronic flow valve, a pneumatic steering switch, a human-computer interaction interface, and a communication module, for example, integrated circuits or wires are used to communicate and work together.
  • the multi-parameter monitoring module may be composed of, for example, medical sensors and signal processing components used for human vital signs monitoring.
  • the multi-parameter monitoring module of the embodiment of the present disclosure should at least meet the dynamic monitoring of more than two vital signs, and should at least include the dynamic monitoring of blood oxygen saturation and respiratory frequency, that is, in the embodiment of the present disclosure, the above At least two of the vital signs must include blood oxygen level and respiratory rate.
  • the multi-parameter monitoring module can transmit the dynamic monitoring result of at least the blood oxygen level to the control module, so that the control module can according to the pre-obtained target blood oxygen level (for example The input obtained from the user through the human-computer interaction interface) and the received blood oxygen level monitoring results adjust the set value of the oxygen output flow, and transmit the adjusted set value of the oxygen output flow to the electronic flow valve, so that the electronic The flow valve adjusts the size of the oxygen output flow according to the received set value of the adjusted oxygen output flow.
  • the pre-obtained target blood oxygen level for example The input obtained from the user through the human-computer interaction interface
  • the received blood oxygen level monitoring results adjust the set value of the oxygen output flow
  • the electronic flow valve adjusts the size of the oxygen output flow according to the received set value of the adjusted oxygen output flow.
  • the multi-parameter monitoring module can recognize the patient's exhalation and inhalation actions and calculate the respiration frequency, and the airway steering switch can use the calculated respiration frequency in the following manner Respond in real time: When the patient performs an inhalation action, the gas path switch turns on the oxygen inhalation/atomization output path, and the oxygen/atomized liquid medicine is output according to the set flow value; when the patient performs an exhalation action, the gas path The steering switch closes the output path, blocking the invalid output of oxygen/medical liquid atomized by the oxygen jet.
  • the multi-parameter monitoring module may include a blood oxygen monitoring module and a respiratory frequency monitoring module to dynamically or in real time monitor the patient's blood oxygen value and respiratory frequency.
  • the multi-parameter monitoring module may also include at least one of a body temperature monitoring module, a heart rate monitoring module, and a blood pressure monitoring module to provide auxiliary functions for the system, that is, the system can provide users with oxygen inhalation and atomization functions.
  • a body temperature monitoring module e.g., a body temperature monitoring module
  • a heart rate monitoring module e.g., a heart rate monitoring module
  • a blood pressure monitoring module e.g., a blood pressure monitoring module to provide auxiliary functions for the system, that is, the system can provide users with oxygen inhalation and atomization functions.
  • it can be conveniently used to measure the user's body temperature, heart rate, blood pressure and other biometric parameters.
  • the blood oxygen monitoring module is mainly composed of a blood oxygen sensor, a blood oxygen calculation module, and a lead wire, and is used to dynamically monitor the patient's blood oxygen saturation, pulse rate, and perfusion index (PI).
  • PI perfusion index
  • the respiratory rate monitoring module is a sensing device used to identify the patient's exhalation and inhalation actions and calculate the respiratory rate.
  • the respiratory frequency monitoring module is prepared by using at least one of a temperature sensor, an acoustic sensor, or a pressure sensor as the core.
  • the working principles and preparation methods of various respiratory frequency monitoring modules can be:
  • a respiratory frequency monitoring module prepared with a temperature sensor as the core its working principle is to use a temperature sensor to sense the patient's breathing action and frequency according to the temperature change of the mouth or nostril when the patient exhales or inhales.
  • the specific method is to select a temperature sensor with a faster response time, set the detection part of the temperature sensor 5mm-10mm around the patient’s mouth or nostril, and connect the temperature sensor output terminal with the signal processing module of the control module through a wire to dynamically monitor the patient’s call. The temperature change during inhalation or inhalation.
  • the control module uses this dynamic monitoring of the temperature difference to determine the breathing action of the patient. When the temperature is ⁇ t1, the control module determines that it is an exhalation action, and when the temperature is ⁇ t2, the control module determines that it is an inhalation action, and then according to breathing and inhalation
  • the breathing rate is calculated by the alternating cycle of air.
  • a respiratory frequency monitoring module prepared with an acoustic sensor as the core its working principle is to use acoustic sensors to sense the patient's breathing action and frequency according to the different acoustic characteristics of the periphery of the airway when the patient exhales or inhales.
  • the specific method is to attach the detection part of the acoustic sensor to the acoustically sensitive parts of the periphery of the respiratory tract, such as the mouth, neck, nasal cavity, chest cavity, etc., and the output end of the acoustic sensor is connected with the signal processing module of the control module through a wire.
  • control module uses two different acoustic characteristics of exhalation or inhalation to determine the patient's breathing motion, and calculates the breathing frequency based on the alternating cycle of breathing and inhalation.
  • a respiratory frequency monitoring module prepared with a pressure sensor as the core its working principle is to use the pressure sensor to sense the patient's breathing action and frequency according to different pressure changes on the periphery of the airway when the patient exhales or inhales.
  • the specific method is to set the detection part of the small-range pressure sensor at 5mm-20mm from the periphery of the patient's mouth or nostril, and the output end of the pressure sensor is connected with the signal processing module of the control module through a wire.
  • the pressure sensor monitors that the periphery of the oral cavity or nostril is in a positive pressure state, while the patient's oral cavity or the periphery of the nostril is in a negative pressure state during inhalation.
  • the control module uses the obtained pressure value change to determine the patient's exhalation or inhalation action, and the control module determines that it is expiration when the pressure is positive. Air action, when negative pressure, the control module determines that it is an inhalation action, and calculates the breathing frequency according to the alternating cycle of breathing and inhalation.
  • a simpler way to install the pressure sensor on the periphery of the patient’s mouth or nostril is to set the pressure sensor detection part in the oxygen mask or nebulizer mask, and fix the oxygen mask or nebulizer mask on the periphery of the patient’s mouth or nasal cavity.
  • the control module uses the acquired pressure value changes to determine the patient's exhalation or inhalation action.
  • the pressure sensor is arranged in the integrated circuit of the control module, the detection part of the pressure sensor is connected to an extended pressure monitoring hose, and the other end of the pressure monitoring hose is connected to the oxygen inhalation pipe or the atomizer.
  • the control module can also obtain the different pressure values of the patient's exhalation or inhalation, determine the patient's exhalation or inhalation, and calculate the respiratory rate.
  • the body temperature monitoring module may be composed of a body temperature sensor and a signal processing module for continuous monitoring of the patient's body temperature.
  • the heart rate monitoring module may be composed of electrocardiographic electrodes and a signal processing module for continuous monitoring of the patient's heart rate.
  • the blood pressure monitoring module can be composed of a pressure sensor, a micro air pump, and a signal processing module for continuous monitoring of the patient's blood pressure.
  • the electronic flow valve is used for the electric control of the oxygen output flow.
  • the electric control of the oxygen output flow can be realized through the electric control of valve opening, flow adjustment, and valve closing.
  • the electronic flow valve can adopt any suitable electronic valve parts among proportional valves, solenoid valves, thimble valves, and throttle valves.
  • the working pressure of the electronic valve is 0.1Mpa ⁇ 0.6Mpa, the range is not less than 0 ⁇ 10L, the accuracy is not less than 0.5L, and the measurement error is not more than 4%.
  • the electronic flow valve operates according to the flow setting value given by the control module and outputs the corresponding flow of oxygen.
  • the downstream position of the output path of the electronic flow valve is provided with a flow sensor to realize dynamic monitoring and feedback of the output flow.
  • the gas path steering switch is arranged at a downstream position of the output path of the electronic flow valve.
  • the gas circuit steering switch may be a normally closed three-port two-position solenoid valve, wherein the first port is connected to the oxygen input pipeline, the second port is connected to the oxygen inhalation output pipeline, and the third port is connected to the atomization output pipeline.
  • the electronic flow valve in the initial state is in a closed state. In the first position, the oxygen inhalation output pipeline of the electronic flow valve is connected and the atomization output pipeline is closed; in the second position, the atomization output pipeline is connected and the oxygen absorption output pipeline is closed.
  • the gas path switch can realize the switching control of the oxygen output gas path according to the oxygen treatment or atomization treatment instructions given by the control module. For example, when you choose to enter oxygen therapy, the gas circuit steering switch actively switches to the oxygen inhalation output pipeline, and oxygen is output from the oxygen inhalation pathway.
  • the oxygen inhalation pipeline can be connected to the oxygen inhalation output pipeline interface to achieve oxygen therapy; another example, When you choose to enter the atomization treatment, the gas circuit steering switch actively switches to the atomization output pipeline, and the oxygen is output from the atomization channel. Connect the atomizer to the atomization output pipeline interface to realize the atomization treatment.
  • the human-computer interaction interface is mainly composed of an LCD screen and operation function keys.
  • the human-computer interaction interface can be used for the selection of treatment modes, the setting of control parameters, the reading of monitoring information and the operation of other functions.
  • the control parameters include oxygen output flow, target blood oxygen saturation (that is, target blood oxygen value), oxygen inhalation duration, and the like.
  • the operation function keys of the human-computer interaction interface include, for example, an oxygen inhalation time setting key, a flow rate setting key, a target blood oxygen value setting key, and an oxygen inhalation/atomization function switching key.
  • the function keys can adopt various conventional technologies such as buttons, encoders, and touch screens.
  • the communication module is used to remotely send monitoring information, prompts or warning information of the embodiments of the present disclosure to the medical monitoring terminal.
  • the communication module can use traditional wired transmission, Bluetooth, WiFi, ZigBee, or RF technologies.
  • embedded software is provided in the control module, and the embedded software is the core control program of the embodiment of the present disclosure.
  • the embedded software includes oxygen therapy control program and atomization therapy control program. After the medical staff selects the oxygen therapy or atomization therapy function on the man-machine interface, the control module enters the corresponding oxygen therapy control program or the corresponding atomization therapy control program.
  • the oxygen therapy control program is mainly constructed by target blood oxygen value, output flow value, oxygen inhalation duration, target blood oxygen control range, intervention control time, flow adjustment range, flow adjustment gradient, and breathing frequency.
  • the oxygen therapy control program may be provided with three oxygen output control modes, for example, a target blood oxygen servo mode, a breathing synchronization mode, and a target blood oxygen servo + breathing synchronization mode.
  • the atomization control program is mainly constructed by the respiratory frequency and output flow value.
  • the atomization control program can be divided into two oxygen output control modes, for example, ordinary jet atomization and breathing synchronized atomization.
  • each construction element in the control program and the setting method of related parameters are:
  • the target blood oxygen level may refer to the blood oxygen level that is expected to be reached and maintained stably during oxygen therapy, that is, the therapeutic target that is expected to be achieved in this oxygen therapy.
  • the medical staff determines the target blood oxygen value of this oxygen treatment according to the different characteristics of the patient, and sets it in the human-computer interaction interface/or the upper computer software.
  • the target blood oxygen level setting range can be 88% to 99%. For example, it is commonly used: the target blood oxygen value of patients with anesthesia resuscitation is set to 96%, the target blood oxygen value of patients with acute respiratory distress syndrome is set to 92%, and the target blood oxygen value of patients with hypercapnia is set. It is set at 90%, the target blood oxygen value for neonatal patients with routine oxygen inhalation is set to 93%, and the target blood oxygen value for patients with routine oxygen inhalation is set to 96%.
  • the output flow value can be the oxygen flow as prescribed by the doctor during oxygen therapy, generally in "L/min".
  • the medical staff can set it in the human-computer interaction interface/or the host computer software.
  • the duration of oxygen inhalation can be the length of time from the beginning to the end of this oxygen therapy, usually in hours (h).
  • the oxygen inhalation time is set by the medical staff in the human-computer interaction interface/or the host computer software. After the oxygen inhalation time is reached, the control module gives an instruction to close the oxygen output, so that the electronic flow valve closes the oxygen output path, and the oxygen treatment ends .
  • the target blood oxygen control range may be a limited interval value that allows the target blood oxygen value to be a reference value and allows the blood oxygen value to dynamically deviate, that is, the upper limit value and the lower limit value range of the blood oxygen value that is expected to be stably maintained during oxygen therapy.
  • the target blood oxygen control range is automatically given according to the set target blood oxygen value ⁇ 1%" or ⁇ 2%", and the target blood oxygen control range is written into the oxygen therapy control program.
  • the target blood oxygen control range is a fluctuation range relative to the set target blood oxygen value.
  • the target blood oxygen control range is written in the control program of oxygen therapy according to the standard of "target blood oxygen value ⁇ 2%"
  • the target blood oxygen value set by the medical staff on the human-machine interface is 96%
  • the target blood oxygen control range in the oxygen therapy control program is determined to be between 94% and 98%.
  • the intervention control time may refer to the corresponding delay time for the control module to intervene in adjusting the oxygen output flow after the patient's blood oxygen value starts to deviate from the target blood oxygen control range.
  • the intervention control time is in minutes (min).
  • the intervention control time is written into the oxygen therapy control program.
  • the intervention control time setting range is: increase the flow rate intervention control time for the first time period, for example, less than 1 min, and reduce the flow rate adjustment intervention control time for the second time period, for example, between 1 and 10 minutes between.
  • the target blood oxygen control range is between 94% and 98%
  • the intervention control time for increasing the flow rate is 0.5 min
  • the intervention control time for reducing the flow adjustment is between 3 minutes
  • the control module intervenes in the flow adjustment, and the electronic flow valve increases the oxygen output flow; on the contrary, when the patient's blood oxygen value reaches the upper limit of the target blood oxygen control range of 98% After 3 minutes, the control module intervenes in flow adjustment, and the electronic flow valve reduces the oxygen output flow.
  • the flow adjustment range may refer to the interval value during which the control module intervenes in adjusting the oxygen output flow, that is, the range between the minimum and maximum oxygen output when the control module intervenes in the flow adjustment, in minutes (L/min).
  • the flow adjustment range is written into the oxygen therapy control program. Due to individual differences in patients, there are different flow adjustment ranges in the oxygen therapy control program.
  • the flow adjustment range can be divided into four adjustment intervals, for example: low-flow oxygen inhalation patients with a flow rate of 0.5L/min ⁇ 2L/min set by the doctor ,
  • the flow adjustment range is between 0.5L/min ⁇ 2L/min;
  • the doctor’s order set flow rate is 3L/min ⁇ 4L/min for medium flow oxygen inhalation patients, the flow adjustment range is between 1L/min ⁇ 4L/min;
  • doctor’s order The set flow rate is 5L/min ⁇ 6L/min for high-flow oxygen inhalation patients, the flow adjustment range is between 1L/min ⁇ 6L/min;
  • the doctor’s set flow rate is 7L/min ⁇ 10L/min for ultra-high-flow oxygen inhalation ,
  • the flow adjustment range is between 1L/min ⁇ 10L/min.
  • the flow adjustment gradient may refer to the gradient value of the electronic flow valve increasing or decreasing the oxygen output flow when the control module intervenes in the control, in minutes (L/min).
  • the flow adjustment gradient is written into the oxygen therapy control program.
  • the flow rate adjustment gradient is generally between 0.1 L/min and 1 L/min.
  • the flow rate adjustment gradient can be set between 0.2 L/min and 0.5 L/min.
  • Respiration rate includes identifying the patient's exhalation/inspiration action and calculating the respiration rate.
  • the breathing rate can be dynamically monitored during oxygen therapy.
  • the medical staff when the oxygen therapy function is selected, can, for example, set the target blood oxygen value on the human-computer interface according to the patient's hypoxia level, and the oxygen therapy control program can automatically determine the target blood oxygen control range.
  • the oxygen therapy control program After the medical staff sets the output flow value of this oxygen therapy (ie, the doctor's order flow), optionally, the oxygen therapy control program automatically determines the flow adjustment range.
  • the electronic flow valve can output oxygen according to the working mode given by the control module.
  • the multi-parameter monitoring module can simultaneously perform dynamic monitoring of multiple physiological parameters, including dynamic monitoring of physiological parameters such as blood oxygen saturation, pulse rate, respiratory rate, body temperature, heart rate, blood pressure, etc., and the communication module can simultaneously upload various physiological parameters The monitoring information to the PC of the nursing terminal.
  • physiological parameters such as blood oxygen saturation, pulse rate, respiratory rate, body temperature, heart rate, blood pressure, etc.
  • the communication module can simultaneously upload various physiological parameters The monitoring information to the PC of the nursing terminal.
  • the working principles of the three oxygen output control modes in the oxygen therapy control program are, for example:
  • Target blood oxygen servo mode When the target blood oxygen servo mode is used for oxygen therapy, for example, the oxygen output flow is dynamically controlled based on the patient's current blood oxygen value and the set target blood oxygen value. When the patient's blood oxygen value begins to deviate from the target blood oxygen control range, the control module automatically adjusts the oxygen output flow according to the intervention control time, flow adjustment gradient and flow adjustment range defined in the embedded software. The adjustment method is to increase or decrease the oxygen. Output flow until the patient's blood oxygen level stabilizes within the target blood oxygen control range.
  • the specific implementation method of target blood oxygen servo mode oxygen therapy is, for example: during oxygen therapy, when the patient's blood oxygen level drops to the lower limit of the target blood oxygen control range, the control module adjusts the gradient according to the defined intervention control time and flow rate Increase the oxygen output flow until the patient's blood oxygen level is stable within the target blood oxygen control range; after the control module increases the oxygen output flow, if the patient's blood oxygen level is still lower than the lower limit of the target blood oxygen control range, the control module is as defined The flow adjustment gradient continues to increase the oxygen output flow until the upper limit of the flow adjustment range; when the increased oxygen output reaches the upper limit of the flow adjustment range, if the patient’s blood oxygen level is still below the target blood oxygen control range, the man-machine interface will give blood oxygen If the value deviates from the alarm, the medical staff shall handle it.
  • the control module reduces the oxygen output flow according to the defined intervention control time and flow adjustment gradient until the lower limit of the flow adjustment range; the oxygen output flow is reduced to the flow adjustment range
  • the man-machine interface gives advice to stop oxygen inhalation.
  • the electronic flow valve closes the oxygen output, and a prompt message indicating the end of oxygen inhalation is given on the man-machine interface.
  • the breathing rate monitoring module recognizes the patient's exhalation and inhalation action and calculates the respiration frequency, so that the oxygen output and the respiration frequency are controlled synchronously.
  • the gas path switch automatically or under the control of, for example, the control module, makes the following real-time response according to the breathing rate:
  • the gas path switch turns on oxygen inhalation In the output path, oxygen is output according to the set flow value; when the patient performs an exhalation action, the gas path switch closes the output path, blocking the invalid output of oxygen.
  • the breathing synchronization mode is adopted for oxygen therapy to keep the oxygen output synchronized with the patient's breathing movement, and at least about 50% of oxygen consumption can be saved during oxygen therapy.
  • Target blood oxygen servo + breathing synchronization mode This mode combines the technical characteristics of the above (1) and (2) two oxygen output control modes.
  • the target blood oxygen servo + breathing synchronization mode it is necessary to dynamically adjust the oxygen output flow according to both the target blood oxygen value and the patient's current blood oxygen value, and the oxygen output must be related to the patient's breathing action , That is, when the patient inhales, the gas path switch turns on the oxygen inhalation output path, and when the patient exhales, the gas path switch closes the oxygen inhalation output path.
  • oxygen output is dynamically controlled based on the target blood oxygen value, and the oxygen output flow is automatically adjusted according to the patient's blood oxygen value changes, so that the patient's blood oxygen value is stably maintained within the target blood oxygen control range ;
  • the oxygen output is dynamically controlled according to the patient's breathing rate/respiratory action, so that the oxygen output is synchronized with the patient's breathing action, saving about 50% of oxygen consumption.
  • medical staff can choose one of two modes: ordinary jet nebulization or respiratory synchronization nebulization according to clinical needs.
  • Ordinary atomization for example, means that oxygen enters the atomization cup according to the set output flow, and the strong air jet impacts the liquid to form aerosol, which is continuously output in the mouthpiece or cup of the atomizer. This is also the current traditional aerodynamic jet. Atomization method.
  • Breath-synchronized atomization refers to an atomization treatment method in which the jet atomization action is synchronized with the patient's breathing frequency.
  • the gas path switch turns on the nebulization output path, and the medical staff sets the oxygen output flow on the human-computer interaction interface according to the characteristics of the medicine.
  • the oxygen output flow of the nebulization therapy is generally set Set between 5L/min ⁇ 8L/min.
  • the respiratory rate monitoring module actively recognizes the patient's exhalation and inhalation and calculates the respiratory rate, and the airway steering switch autonomously or under the control of the control module according to the calculated respiratory rate of the patient in the following manner For example, make a real-time response; when the patient performs an inhalation action, the gas path switch turns on the atomization output path, and the liquid medicine is atomized and output under the action of the oxygen jet, and sprayed into the patient's inhalation airway; when the patient performs an exhalation action, The gas circuit steering switch closes the output path, blocks oxygen from entering the atomization cup, and stops the atomization output of the liquid medicine.
  • the atomization output of the liquid medicine is synchronized with the patient's breathing action, reducing the exhalation of the atomized liquid medicine in the patient It is released ineffectively during action, which at least doubles the utilization rate of the atomized liquid medicine.
  • the beneficial effects of the embodiments of the present disclosure include, for example, the provision of a multifunctional oxygen output control device, which can provide multiple treatment modes during the process of oxygen therapy and atomization therapy in medical units to meet different clinical needs;
  • the provided oxygen output system can save about 50% of oxygen or drug resources when adopting the treatment mode of respiratory frequency synchronization, which has good social significance; in addition, the provided oxygen output system is used in the process of oxygen therapy or atomization therapy Real-time monitoring of multiple physiological parameters such as blood oxygen saturation, respiratory rate, pulse rate, body temperature, heart rate and blood pressure ensures the effectiveness of treatment.
  • Fig. 1 is a structural block diagram of a multifunctional oxygen output system provided by an embodiment of the present disclosure.
  • a list of main components used in the multifunctional oxygen output system provided by the embodiments of the present disclosure for example:
  • the control module adopts ARM microcontroller (MCU), model STM32F415RGT6, ST STMicroelectronics.
  • the multi-parameter monitoring module is constructed by five modules: blood oxygen monitoring module, respiratory frequency monitoring module, body temperature monitoring module, heart rate monitoring module, and blood pressure monitoring module.
  • the specific requirements are that the blood oxygen sensor adopts two-color light-emitting diode PDFE833, the emission wavelength is 660nm and 940nm, finger clip type, the blood oxygen saturation monitoring range is 70% to 100% (no definition below 70%), and the measurement error is not more than 3 %;
  • the respiratory frequency sensor is made with a micro-pressure sensor as the core, with a range of 0-50kPa, and a measurement accuracy of 0.01kPa.
  • the body temperature monitoring module uses a patch thermistor as the detection part, with a range of 25 °C ⁇ 45°C, measurement accuracy of 0.1°C, measurement error of 0.2°C; heart rate electrode range 25cpm ⁇ 250cpm, measurement accuracy 1cpm, measurement error +3cpm; blood pressure sensor uses gas pressure sensor as the core production, range 0 ⁇ 700kPa, accuracy 0.1KPa.
  • the electronic flow valve adopts a proportional valve driven by a stepping motor.
  • the range of the flow sensor is 0-10L, the maximum withstand voltage is 0.6MPa, the range of the flow sensor is 0-15L, the accuracy is 0.1L, and the measurement error does not exceed 4%.
  • the pneumatic steering switch adopts a miniature normally closed solenoid valve with three ports and two positions, the power supply voltage is 12V, the maximum working pressure is 0.8MPa, and the response time is not more than 50 milliseconds.
  • Communication module adopts WiFi module, model QCA9377, produced by Qualcomm
  • storage module adopts Samsung HY27US08561A (64M)
  • power supply adopts 12V
  • 1A medical power adapter adopts 5-inch LCD display
  • 2 encoders and 3 It is composed of function keys
  • the product protective shell is injection molded of non-toxic polypropylene material.
  • the general production process of electronic products is used to prepare the PCB, the circuit board is produced by the conventional technology of patching, welding, assembly and other processes, and the components of the electronic flow valve and the gas circuit steering switch are assembled. , Install the shell and control buttons, and test the aging after the instrument is assembled.
  • the software should meet the oxygen output control method proposed in the embodiments of the present disclosure to realize oxygen therapy, nebulization therapy, dynamic monitoring of multiple physiological parameters, and remote communication And other functions.
  • the treatment subject is diagnosed as a patient with carbon dioxide retention, coughing and sputum, and selecting the target blood oxygen servo + breathing synchronization mode.
  • the target blood oxygen range is 88% to 92%
  • the oxygen inhalation time is 20 hours
  • the oxygen flow rate is 2L/min.
  • aerosol treatment was performed, and the aerosol liquid was configured to dissolve 0.2g ambroxol in 5ml gentamicin.
  • the medical staff set the target blood oxygen value to 90% on the human-computer interaction interface, set the oxygen inhalation time for 20 hours, and set the oxygen flow rate of 2L/min (
  • the flow adjustment range is between 0.5L/min and 2L/min.
  • the breathing rate monitoring module starts to monitor the patient's breathing in real time.
  • the airway steering switch responds in real time to changes in the breathing rate.
  • Oxygen is normally delivered to the patient's respiratory tract when the patient inhales, and oxygen delivery is stopped when the patient exhales.
  • the control module will give an instruction to reduce the oxygen output flow, and the electronic flow valve will reduce the oxygen output according to the flow adjustment gradient, reducing the gradient each time It is 0.25L/min; when the oxygen output flow is reduced and the patient’s blood oxygen saturation remains stable at 92%, continue to decrease a gradient every 3 minutes until the minimum flow adjustment range is 0.5L/min; on the contrary, if When the patient's blood oxygen level drops to 88% of the lower limit of the target blood oxygen control range, the control module gives an instruction to increase the oxygen output flow within 0.5 minutes, and the electronic flow valve increases the oxygen output according to the flow adjustment gradient, each time increasing The gradient is 0.25L/min, and the gradient is increased every 0.5min until the maximum value of the flow adjustment range is 2L.
  • the control module will give a warning message, which is displayed on the human-machine interface and remotely transmitted to The nursing terminal prompts the medical staff to perform manual intervention.
  • the medical staff switched to the atomization therapy function on the human-computer interaction interface, and selected the atomization in the breathing synchronization mode.
  • a micro pressure sensor is provided, and the output end of the micro pressure sensor is connected to the signal input port of the control board of the embodiment of the present disclosure with a wire serial port, the oxygen output flow rate is set to 6L/min, and the atomization is turned on.
  • the respiratory rate monitoring module actively recognizes the patient's exhalation and inhalation actions, and the airway steering switch responds in real time according to the patient's respiratory rate.
  • the liquid medicine is atomized and output, and sprayed into the patient's inhalation airway;
  • the gas path switch closes the output path, blocking oxygen from entering the atomizing cup, and the liquid medicine stops atomizing , So repeatedly.
  • the medical staff switch back to the original oxygen treatment mode and continue the oxygen treatment.
  • the electronic flow valve automatically turns off the oxygen output, and the man-machine interface prompts that the oxygen therapy is over.
  • the heart rate sensor, body temperature sensor, and blood pressure sensor of the multi-parameter monitoring module to the control module of the embodiment of the present disclosure to dynamically monitor the heart rate, Body temperature and blood pressure parameters, and upload the acquired physiological parameters to the medical terminal remotely.
  • the embodiments of the present disclosure provide a multifunctional oxygen output system, which can provide multiple treatment modes in the process of oxygen therapy and atomization treatment in medical units to meet different clinical needs; the provided oxygen output system adopts breathing
  • the frequency-synchronized treatment mode can save about 50% of oxygen or drug resources; in addition, the provided oxygen output system can monitor multiple physiological parameters such as blood oxygen saturation, respiratory rate, and respiratory rate during oxygen therapy or nebulization therapy. Pulse rate, body temperature, heart rate and blood pressure ensure the effectiveness of treatment.

Abstract

L'invention concerne un système multifonctionnel de production d'oxygène basé sur une régulation coopérative d'une fréquence respiratoire et d'une valeur cible d'oxygène dans le sang, constitué principalement d'un module de commande, d'un module de surveillance de plusieurs paramètres, d'un clapet anti-retour électronique, d'un commutateur de déviation de trajet d'air, d'une interface d'interaction homme-ordinateur et d'un module de communication. Le système multifonctionnel de production d'oxygène présente les effets bénéfiques consistant en une pluralité de modes de traitement dans le processus de traitement à l'oxygène et de traitement par nébulisation dans des unités médicales sont prévus pour satisfaire à différents besoins cliniques ; environ 50 % d'oxygène ou de ressources médicamenteuses sont sauvegardées lorsqu'un mode de traitement synchronisé avec la fréquence respiratoire est utilisé ; et une pluralité de paramètres physiologiques sont surveillés en temps réel pendant le traitement à l'oxygène ou le traitement par nébulisation, ce qui permet d'assurer l'efficacité du traitement.
PCT/CN2020/070907 2019-08-05 2020-01-08 Système multifonctionnel de production d'oxygène basé sur une régulation coopérative de la fréquence respiratoire et de la valeur cible d'oxygène dans le sang WO2021022785A1 (fr)

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CN201910715675.7A CN110269988A (zh) 2019-08-05 2019-08-05 基于呼吸频率和目标血氧值协同控制的氧气输出系统
CN201911092478.0A CN110639101A (zh) 2019-11-11 2019-11-11 基于呼吸频率和目标血氧值协同控制的多功能氧气输出系统
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