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WO2023230868A1 - 控制通气设备的方法、通气系统和通气设备 - Google Patents

控制通气设备的方法、通气系统和通气设备 Download PDF

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Publication number
WO2023230868A1
WO2023230868A1 PCT/CN2022/096321 CN2022096321W WO2023230868A1 WO 2023230868 A1 WO2023230868 A1 WO 2023230868A1 CN 2022096321 W CN2022096321 W CN 2022096321W WO 2023230868 A1 WO2023230868 A1 WO 2023230868A1
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WIPO (PCT)
Prior art keywords
ventilation
parameters
diaphragm
subject
target
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PCT/CN2022/096321
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English (en)
French (fr)
Inventor
刘京雷
周小勇
黄志文
王建新
Original Assignee
深圳迈瑞生物医疗电子股份有限公司
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Application filed by 深圳迈瑞生物医疗电子股份有限公司 filed Critical 深圳迈瑞生物医疗电子股份有限公司
Priority to PCT/CN2022/096321 priority Critical patent/WO2023230868A1/zh
Priority to CN202280071679.6A priority patent/CN118139668A/zh
Priority to EP22944205.8A priority patent/EP4483930A4/en
Publication of WO2023230868A1 publication Critical patent/WO2023230868A1/zh

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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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • 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. ventilators; 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. ventilators; 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
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/054—General characteristics of the apparatus combined with other kinds of therapy with electrotherapy
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1014—Diaphragm
    • 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
    • A61M2230/202—Blood composition characteristics partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
    • 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
    • A61M2230/60—Muscle strain, i.e. measured on the user

Definitions

  • the present application relates to the technical field of medical equipment, and more specifically to a method of controlling ventilation equipment, a ventilation system and ventilation equipment.
  • Mechanical ventilation therapy is often used to provide ventilatory support to critically ill patients or patients undergoing anesthesia surgery.
  • respiratory failure is the most common organ failure, seriously threatening the patient's life safety.
  • Patients undergoing anesthesia surgery lose the ability to breathe on their own and therefore require mechanical ventilation support.
  • the current mechanical ventilation is mainly positive pressure ventilation.
  • the respiratory muscles contract, causing the pressure in the chest to decrease, which in turn causes the pressure in the lungs to decrease below atmospheric pressure.
  • atmospheric gas can enter the lungs to form inhalation.
  • the respiratory muscles relax and the pressure in the lungs is greater than the external atmospheric pressure, allowing the air to be exhaled.
  • positive pressure ventilation mainly provides all or part of the respiratory driving force by ventilation equipment such as ventilators or anesthesia machines. Gas is sent out through the valve during inhalation. The airway pressure is greater than the pressure in the lungs, and the gas can enter the lungs and exhale. When the gas is released through the valve, the airway pressure is less than the pressure in the lungs, and the gas can be exhaled.
  • Positive pressure ventilation causes pressure injury to the lungs, and excessive tidal volume may cause volume trauma.
  • Positive pressure ventilation causes intrathoracic pressure to rise, which compresses the heart, leading to an increase in right ventricular preload, etc., which in turn affects cardiac output, leading to suppression of circulation.
  • Prolonged mechanical ventilation can also lead to disuse atrophy of respiratory muscles such as the diaphragm, making it difficult for patients to wean themselves off the machine.
  • Diaphragm pacing technology uses invasive or non-invasive methods to electrically stimulate the phrenic nerve or diaphragm muscle to increase the activity of the diaphragm and thereby improve breathing.
  • This treatment method is mainly used in rehabilitation departments, such as patients with spinal cord injuries.
  • PEEP Positive End-expiratory Pressure
  • the first aspect of the embodiment of the present application provides a method for controlling ventilation equipment, including:
  • physiological state parameters representing the physiological state of the ventilated subject, the physiological state parameters including monitoring parameters related to ventilation;
  • the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilation subject is set, and the ventilation parameters of the mechanical ventilation of the ventilation subject are set to achieve the desired effect on the ventilation target. Ventilated subjects underwent diaphragm pacing and mechanical ventilation.
  • a second aspect of the embodiment of the present application provides a ventilation system, which includes:
  • Ventilation equipment including:
  • Breathing circuit used to deliver gas provided by the gas source to the ventilation object for mechanical ventilation
  • a diaphragm pacing device used to contact the target position of the ventilation subject through a stimulation electrode and send a stimulation signal to the target position, thereby pacing the diaphragm of the ventilation subject;
  • a processor connected to the ventilation device and the diaphragm pacing device, is used to set the ventilation parameters of the mechanical ventilation and set the intensity of the stimulation signal for the diaphragm pacing.
  • the third aspect of the embodiment of the present application provides a ventilation device, including:
  • Breathing circuit used to deliver gas provided by the gas source to the ventilation object for mechanical ventilation
  • a communication module configured to communicate with a diaphragm pacing device; the diaphragm pacing device is configured to contact the target position of the ventilation object through a stimulation electrode, and send a stimulation signal to the target position, thereby providing the ventilation object with Diaphragm pacing;
  • a processor configured to control ventilation parameters of the mechanical ventilation and stimulation intensity of the diaphragm pacing.
  • the method, ventilation system and ventilation device for controlling ventilation equipment combine the positive pressure ventilation of the ventilation equipment with the negative pressure ventilation generated by diaphragm pacing, which can reduce the pressure of positive pressure ventilation during mechanical ventilation, thereby reducing Thoracic pressure can reduce or avoid lung damage or circulatory depression caused by mechanical ventilation.
  • by stimulating the diaphragm to cause it to contract it can reduce disuse atrophy of the diaphragm and avoid dependence on ventilation equipment.
  • Figure 1 shows a schematic flow chart of a method for controlling ventilation equipment according to an embodiment of the present application
  • FIG. 2 shows a schematic block diagram of a ventilation system according to an embodiment of the present application
  • Figure 3 shows a schematic block diagram of a ventilation device according to an embodiment of the present application.
  • Figure 1 is a schematic flow chart of a method 100 for controlling a ventilation device according to an embodiment of the present application.
  • the method 100 of controlling ventilation equipment includes the following steps:
  • step S110 physiological state parameters representing the physiological state of the ventilation subject are obtained, where the physiological state parameters include monitoring parameters related to ventilation;
  • step S120 obtain a ventilation target that provides mechanical ventilation for the ventilation subject
  • step S130 based on the physiological state parameters and the ventilation target, set the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilation object, and set the ventilation parameters of mechanical ventilation for the ventilation object, to perform diaphragm pacing and mechanical ventilation on the ventilated subject.
  • the method 100 of controlling ventilation equipment in the embodiment of the present application controls the stimulation intensity of diaphragm pacing and the ventilation parameters of mechanical ventilation based on the physiological state parameters of the ventilated subject and the ventilation target, and combines mechanical ventilation with the negative pressure ventilation generated by diaphragm pacing. It can reduce the pressure of positive pressure ventilation during mechanical ventilation, thereby reducing thoracic pressure, reducing or avoiding lung damage or circulatory depression caused by mechanical ventilation. At the same time, it can stimulate the diaphragm to cause it to contract, which can reduce the disuse atrophy of the diaphragm. , to avoid dependence on ventilation equipment.
  • the ventilation device at least includes a sensor and a breathing circuit.
  • the sensor is used to obtain monitoring parameters related to ventilation.
  • the breathing circuit is used to deliver gas provided by the gas source to the ventilation object for mechanical ventilation.
  • the gas provided by the gas source may be Air or a mixture of air and oxygen.
  • Diaphragm pacing is provided by a diaphragm pacing device, which can be implemented as a module of a ventilation device.
  • the diaphragm pacing device can be a plug-in module, an external module, or a built-in integrated module of the ventilation device.
  • Diaphragm pacing devices can also be implemented as stand-alone devices.
  • the diaphragm pacing device can operate independently or as a module integrated into a ventilation device.
  • the diaphragm pacing device contacts the target location of the ventilated subject through the stimulation electrode and sends a stimulation signal to the target location, thereby pacing the diaphragm of the ventilated subject.
  • Diaphragm pacing devices can be stimulated invasively or noninvasively.
  • invasive methods include implanting stimulation electrodes in the body of the ventilated subject, or inserting electrode needles through the body surface for stimulation; non-invasive methods include electrical stimulation through body surface electrodes, or magnetic stimulation through induction coils.
  • the target location stimulated by the diaphragm pacing device includes at least one of the following: phrenic nerve, diaphragm, and abdominal muscle.
  • the diaphragm is the main respiratory muscle. Contraction of the diaphragm will cause the diaphragm to descend, thereby expanding the chest cavity in all directions and reducing intrapulmonary pressure, allowing external air to enter the lungs. When the diaphragm relaxes, the top of the diaphragm rises, the volume of the chest cavity decreases, and the lungs retract, thereby expelling air from the lungs.
  • the phrenic nerve is the nerve that controls the movement of the diaphragm. Stimulating the phrenic nerve can cause the diaphragm to contract.
  • the abdominal muscles are also the main muscle group involved in active exhalation and can change the intra-abdominal pressure to help empty the lungs.
  • the phrenic nerve stimulation electrode is used to stimulate the phrenic nerve that controls the movement of the diaphragm to cause the diaphragm to contract and relax
  • the phrenic nerve reference electrode is used to form a circuit with the phrenic nerve stimulation electrode.
  • the abdominal muscle stimulating electrode is used to stimulate the abdominal muscles to contract and relax
  • the abdominal muscle reference electrode is used to form a circuit with the abdominal muscle stimulating electrode. It should be noted that the location, number, etc. of the stimulation electrodes are only examples, and the embodiments of the present application do not limit the specific structure of the diaphragm pacing device.
  • the method 100 of controlling a ventilation device in the embodiment of the present application is implemented by a processor.
  • the processor may be a processor of a ventilation device, a processor of a diaphragm pacing device, or other external devices that are communicatively connected to the ventilation device and the diaphragm pacing device.
  • the processor acquires a ventilation target that provides mechanical ventilation to the ventilated object, and acquires physiological state parameters representing the physiological state of the ventilated object, as a basis for collaborative control of mechanical ventilation and diaphragm pacing, based on the parameters representing the ventilated object.
  • the physiological state parameters of the physiological state and the ventilation target of mechanical ventilation are set, the ventilation parameters of mechanical ventilation and the intensity of the stimulation signal for diaphragm pacing are set, and the ventilation equipment and the diaphragm pacing equipment are collaboratively controlled, so that the ventilation target is finally achieved.
  • the physiological state parameters at least include monitoring parameters related to ventilation.
  • Ventilation-related monitoring parameters may be collected by sensors of the ventilation device.
  • ventilation-related monitoring parameters may be collected by the processor of the ventilation device through a sensor of the ventilation device during the ventilation process.
  • ventilation-related monitoring parameters collected by a sensor of the ventilation device may be obtained through a communication connection with the ventilation device.
  • the monitoring parameters related to ventilation may include at least one of the monitored pressure, flow, volume, and time of ventilation, or may include at least one derived from the pressure, flow, volume, and time of ventilation. Parameters, such as parameters reflecting pressure or flow change characteristics, etc.
  • physiological status parameters can also include other parameters that can reflect the physiological status of the ventilated subject, such as blood oxygen, blood pressure, carbon dioxide, heart rate, diaphragm electromyography, transdiaphragmatic pressure, esophageal pressure, electrical impedance, ultrasound At least one of the parameters related to blood gas.
  • the above physiological state parameters can be collected by ventilation equipment, or can also come from other medical equipment that is connected to the processor.
  • heart rate, blood pressure, blood oxygen and other parameters can come from monitors
  • ultrasound parameters can come from ultrasound equipment, etc. This part of physiological parameters can reflect the impact of mechanical ventilation and diaphragm pacing on the physiological state of the ventilated subject from the side, thereby assisting decision-making on the control of mechanical ventilation and diaphragm pacing.
  • ventilation goals for providing mechanical ventilation to a ventilated subject include tidal volume goals or spontaneous breathing intensity goals.
  • the tidal volume target is the tidal volume expected to be achieved during ventilation
  • the spontaneous breathing intensity target is the spontaneous breathing intensity expected to be achieved during ventilation.
  • the ventilation target is a tidal volume target
  • the tidal volume target is achieved by setting the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilation subject and setting ventilation parameters for mechanical ventilation of the ventilation subject.
  • the spontaneous breathing intensity target is achieved by setting the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilated subject and setting the ventilation parameters of mechanical ventilation for the ventilated subject.
  • the ventilation parameters of mechanical ventilation include at least one of pressure, flow, volume, time, respiratory ratio, respiratory rate, triggering mode and trigger sensitivity of mechanical ventilation provided by the ventilation equipment.
  • the ventilation parameters may also include ventilation parameters provided by the ventilation equipment. Parameters derived from at least one of mechanical ventilation pressure, flow, volume and/or time, respiratory ratio, respiratory rate, trigger mode, and trigger sensitivity. Ventilation parameters may also include parameters related to devices that can control pressure, flow, etc., or any other parameters that can affect mechanical ventilation.
  • the intensity of the stimulation signal from the diaphragm pacing device is related to the stimulation method of the diaphragm pacing.
  • the way in which the diaphragm pacing device generates stimulation to the target location includes at least one of the following: current stimulation, voltage stimulation, and magnetic stimulation.
  • current stimulation the stimulation intensity is adjusted by adjusting the stimulation current
  • voltage stimulation the stimulation intensity is adjusted by adjusting the stimulation voltage.
  • Magnetic stimulation mainly acts on the nervous system through pulsed magnetic fields, changing the membrane potential of cortical nerve cells, causing them to generate induced currents and generate neural electrical activity.
  • the stimulation intensity can be adjusted by adjusting the intensity of the pulsed magnetic field.
  • the acquired physiological state parameters also include respiratory parameters related to the spontaneous breathing of the ventilated subject, used to reflect the spontaneous breathing state of the ventilated subject.
  • Respiratory parameters related to spontaneous breathing include pressure, flow rate, etc. For example, you can judge whether the ventilated subject is breathing spontaneously through the difference between the flow rate at the inspiratory end and the expiratory end, or detect the change in pressure in the breathing circuit to determine whether the ventilated subject is autonomous. breathe.
  • the spontaneous breathing cycle of the ventilated subject can be determined based on the breathing parameters related to spontaneous breathing, and the intensity of the stimulation signal for diaphragm pacing and the ventilation parameters of mechanical ventilation can be controlled according to the spontaneous breathing cycle to achieve the ventilation goal.
  • the ventilated subject actively inhales, causing the pressure in the airway to drop or the flow rate to change.
  • the ventilated subject's inhalation action When the ventilated subject's inhalation action is sensed, air delivery begins, and the diaphragm is stimulated to contract the diaphragm, thereby causing the ventilated subject to actively inhale,
  • the air supply of mechanical ventilation and diaphragm pacing are synchronized to avoid human-machine confrontation, reduce the discomfort of the ventilated subjects, and avoid possible complications. Since the embodiment of the present application collaboratively controls mechanical ventilation and diaphragm pacing, the spontaneous breathing cycle recognized by the ventilation device can be used to control diaphragm pacing, ensuring the synchronization of diaphragm pacing, mechanical ventilation and spontaneous breathing.
  • the intensity of the stimulation signal of diaphragm pacing and the ventilation parameters of mechanical ventilation can be controlled according to the set respiratory cycle to achieve the ventilation goal. And ensure the synchronization between the negative pressure ventilation of diaphragm pacing and the positive pressure ventilation of mechanical ventilation.
  • sending a stimulation signal to the diaphragm of the ventilated subject includes sending a stimulation signal to the diaphragm, and also includes sending a stimulation signal to the phrenic nerve.
  • the phrenic nerve stimulation can be output to a phrenic nerve stimulation electrode used to stimulate the phrenic nerve during the inhalation phase.
  • the abdominal muscle stimulation signal is output to the abdominal muscle stimulation electrode during the expiration phase.
  • the diaphragm of the ventilated subject contracts under the stimulation of the phrenic nerve stimulation electrode, thereby generating the driving force for inhalation and increasing the inspiratory tidal volume; the abdominal muscles of the ventilated subject It contracts under the stimulation of the abdominal muscle stimulating electrode, thereby generating expiratory driving force and increasing the expiratory flow rate.
  • diaphragm pacing provides at least part of the respiratory drive through stimulation as described above; the ventilation device needs to at least provide gas with a preset oxygen concentration and achieve positive end-expiratory pressure to compensate for the inability of diaphragm pacing to provide different Insufficient oxygen concentration of the respiratory gas and inability to provide positive end-expiratory pressure.
  • the tidal volume of ventilation can be achieved by both diaphragm pacing and positive pressure ventilation, and the proportions contributed by diaphragm pacing and positive pressure ventilation can be set or configured arbitrarily.
  • the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilated subject can be calculated based on the physiological state parameters and the ventilation target, and the ventilation parameters of mechanical ventilation of the ventilated subject can be calculated, that is, the intensity of the stimulation signal and The ventilation parameters are all obtained through calculation; in other embodiments, any one of the intensity of the stimulation signal and the ventilation parameter can also be a fixed value.
  • the intensity of the diaphragm pacing stimulation signal and the mechanical ventilation may be set.
  • At least one of the ventilation parameters is controlled in a closed loop to achieve the ventilation target. Closed-loop control continuously detects parameters related to the ventilation target, and adjusts the intensity of the stimulation signal and/or ventilation parameters based on the deviation between the detection parameters and the ventilation target to ensure that the ventilation target is continuously achieved during the ventilation process.
  • the stimulation intensity of the stimulation signal and the ventilation parameters can be collaboratively adjusted to achieve the ventilation target; alternatively, the stimulation intensity and one of the ventilation parameters can also be adjusted.
  • the ventilation parameters can be maintained unchanged and the intensity of the stimulation signal can be adjusted to achieve the ventilation target.
  • maintaining the ventilation parameters unchanged may include maintaining the ventilation parameters at the values required to achieve positive end-expiratory pressure, that is, the ventilation equipment is only responsible for providing respiratory gas with a preset oxygen concentration, and ensuring the positive end-expiratory pressure, and the breathing drives all Achieved by diaphragm pacing, thereby increasing the mobility of the diaphragm.
  • the ventilation parameters can also be maintained at the values required to provide respiratory drive, that is, the ventilation device is responsible for part of the respiratory drive.
  • the proportion of the respiratory drive assumed by the diaphragm pacing and the ventilation device can be set arbitrarily, and the details can be automatically set by the processor. Set or set according to user instructions.
  • the intensity of the stimulation signal for diaphragm pacing can also be maintained unchanged, and the ventilation parameters can be adjusted to achieve the ventilation target.
  • diaphragm pacing assumes part of the respiratory drive, and the ventilation device is responsible for providing respiratory gas, ensuring positive end-expiratory pressure, and undertaking the remaining respiratory drive. By adjusting ventilation parameters, the tidal volume target or spontaneous breathing intensity target is achieved. Wait for ventilation goals.
  • the intensity of the stimulation signal and/or the ventilation parameters of mechanical ventilation can be adjusted so that the airway pressure of the ventilated subject is less than the set pressure. Reducing airway pressure, that is, reducing intrathoracic pressure, can avoid pulmonary pressure injuries, reduce the compression of the heart by thoracic pressure, and avoid increasing cardiac load or affecting circulation.
  • the set pressure may be a fixed pressure value, or the set pressure may be adjusted according to the physiological state parameters of the ventilation subject.
  • the method 100 for controlling ventilation equipment combines diaphragm pacing with mechanical ventilation, while providing mechanical ventilation, while reducing thoracic pressure through diaphragm pacing, reducing or avoiding pulmonary pulmonary disease caused by mechanical ventilation.
  • the ventilation system 200 includes a ventilation device 210, a diaphragm pacing device 220, and a processor 230.
  • the ventilation device 210 includes: a sensor for obtaining ventilation-related monitoring. Parameters; the breathing circuit is used to deliver the gas provided by the gas source to the ventilated object for mechanical ventilation; the diaphragm pacing device 220 is used to contact the target position of the ventilation object through the stimulation electrode and send stimulation signals to the target position, thereby regulating ventilation.
  • the subject performs diaphragm pacing; the processor 230 is connected to the ventilation device 210 and the diaphragm pacing device 220, and is used to set ventilation parameters of mechanical ventilation and set the intensity of the stimulation signal for diaphragm pacing.
  • the ventilation system 200 can be used to implement the method 100 of controlling a ventilation device described above. Only the main functions of the ventilation system 200 are described below, and other specific details can be found above.
  • the ventilation device 210 may be implemented as a ventilator, an anesthesia machine, an oxygen therapy machine, or other medical device with a mechanical ventilation function.
  • the breathing circuit of the ventilation device 210 is connected to the air source interface and the ventilation control unit, and is used to deliver gas provided by the air source interface to the ventilation object under the control of the ventilation control unit.
  • the gas provided by the gas source interface to the ventilation object can be oxygen or a mixed gas of air and oxygen.
  • Sensors include, but are not limited to, flow rate sensors for measuring flow rate signals, pressure sensors for measuring pressure signals, etc.
  • the stimulation electrodes of the diaphragm pacing device 220 are invasive electrodes or non-invasive electrodes, and the way in which the diaphragm pacing device 220 stimulates the target location includes at least one of the following: current stimulation, voltage stimulation, and magnetic stimulation.
  • the target location stimulated by the stimulating electrode includes at least one of the following: phrenic nerve, diaphragm, and abdominal muscle.
  • the processor 230 can control the diaphragm pacing device 220 to send a stimulation signal to the diaphragm of the ventilated subject during the inspiratory phase of the respiratory cycle, stimulate the diaphragm contraction, and provide inspiratory drive;
  • the abdominal muscles send stimulation signals that stimulate the abdominal muscles to contract and provide exhalation drive.
  • the processor 230 may be a processor of the ventilation device 210 , a processor of the diaphragm pacing device 220 , or a processor of a third-party device communicatively connected with the ventilation device 210 and the diaphragm pacing device 220 .
  • Processor 230 may be implemented by software, hardware, firmware, or any combination thereof, and may use circuitry, single or multiple application specific integrated circuits, single or multiple general purpose integrated circuits, single or multiple microprocessors, single or multiple Programmed logic devices, or any combination of the foregoing circuits and/or devices, or other suitable circuits or devices.
  • processor 230 may control other components in ventilation device 210, diaphragm pacing device 220, or third party devices to perform desired functions.
  • the ventilation system 200 further includes a communication module for establishing a communication connection between the ventilation device 210 and the processor 230, or between the processor 230 and the diaphragm pacing device 220.
  • the processor 230 is connected through the communication Controls diaphragm pacing devices and/or ventilation devices.
  • the communication module 210 is configured to establish a communication connection between the processor 230 and the diaphragm pacing device 220, and the processor 230 controls the diaphragm pacing device 220 through the communication connection.
  • the communication module 210 is used to establish a communication connection between the processor 230 and the ventilation device 210, and the processor 230 controls the ventilation device 220 through the communication connection.
  • the processor 230 controls ventilation parameters of mechanical ventilation and stimulation intensity of diaphragm pacing by acquiring physiological state parameters representing the physiological state of the ventilated subject, the physiological state parameters including ventilation-related monitoring acquired by sensors. Parameters; obtain the ventilation target for providing mechanical ventilation to the ventilated subject; based on the physiological state parameters and the ventilation target, set the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilated subject, and set the ventilation parameters for mechanical ventilation of the ventilated subject .
  • the monitoring parameters acquired through the sensor include: monitored pressure, flow, volume and/or time of ventilation, and/or derived from at least one of pressure, flow, volume and/or time of ventilation. parameter.
  • the physiological state parameters also include: at least one of blood oxygen, blood pressure, carbon dioxide, heart rate, diaphragm electromyography, transdiaphragmatic pressure, esophageal pressure, electrical impedance, ultrasound and blood gas related parameters.
  • Ventilation parameters for mechanical ventilation of the ventilated subject include: at least one of pressure, flow, volume and/or time of mechanical ventilation provided by the ventilation device, respiratory ratio, respiratory rate, triggering mode, triggering sensitivity, and/or by ventilation Parameters derived from at least one of the pressure, flow, volume and/or time, respiratory ratio, respiratory rate, trigger mode, and trigger sensitivity of mechanical ventilation provided by the device.
  • the processor 230 calculates ventilation parameters for mechanical ventilation based on physiological state parameters and ventilation targets, the strength of the diaphragm pacing stimulation signal, and/or. Further, the processor 230 can perform closed-loop control on the intensity of the diaphragm pacing stimulation signal and/or the ventilation parameters of mechanical ventilation to achieve the ventilation target. For example, the processor 230 can cooperatively adjust the stimulation intensity of the signal and the ventilation parameters to achieve the ventilation goal.
  • the processor 230 can maintain the ventilation parameters unchanged and achieve the ventilation target by adjusting the intensity of the stimulation signal.
  • the ventilation parameters can be maintained at a value required to achieve positive end-expiratory pressure, or the ventilation parameters can be maintained at a value required to provide respiratory drive.
  • the processor 230 may maintain the intensity of the stimulation signal unchanged and adjust the ventilation parameters to achieve the ventilation target.
  • the processor 230 controls the ventilation parameters of the mechanical ventilation and the stimulation intensity of diaphragm pacing to make the airway pressure of the ventilated subject less than the set pressure to reduce lung damage caused by mechanical ventilation.
  • the ventilation target includes a tidal volume target or a spontaneous breathing intensity target.
  • the processor 230 achieves the expected tidal volume by controlling the ventilation parameters of mechanical ventilation and the stimulation intensity of diaphragm pacing; when the tidal volume target is used, the processor 230 controls the ventilation parameters of mechanical ventilation and diaphragm pacing The stimulation intensity of the pulse achieves the expected intensity of spontaneous breathing.
  • the spontaneous breathing cycle of the ventilated subject can be determined based on the breathing parameters related to spontaneous breathing, and the intensity of the diaphragm pacing stimulation signal and the ventilation parameters of mechanical ventilation can be controlled according to the spontaneous breathing cycle to achieve the ventilation goal. Thereby enhancing human-machine synchronization.
  • the intensity of the stimulation signal for diaphragm pacing and the ventilation parameters of mechanical ventilation can be controlled according to the set respiratory cycle to achieve the ventilation goal.
  • the ventilation system 200 in the embodiment of the present application uses a processor to cooperatively control the diaphragm pacing device and the ventilation device, thereby reducing or avoiding lung damage or circulation suppression caused by mechanical ventilation and preventing disuse atrophy of the diaphragm.
  • the ventilation device 300 of the embodiment of the present application includes: a sensor 310, used to obtain ventilation-related monitoring parameters of the ventilation object; a breathing circuit 320, used to deliver gas provided by the gas source to the ventilation object for mechanical operation. Ventilation; the communication module 340 is used to communicate with the diaphragm pacing device 400; the diaphragm pacing device 400 is used to contact the target position of the ventilation object through the stimulation electrode and send stimulation signals to the target position, thereby providing diaphragm pacing for the ventilation object. ; Processor 330, used to control ventilation parameters of mechanical ventilation and stimulation intensity of diaphragm pacing.
  • the ventilation device 300 can be implemented as a medical device with a mechanical ventilation function such as a ventilator, an anesthesia machine, and an oxygen therapy machine.
  • the communication connection provided by the communication module 340 may be a wired connection or a wireless connection.
  • the processor 330 controls the stimulation intensity of diaphragm pacing provided by the diaphragm pacing device 400 through the communication connection provided by the communication module 340.
  • the stimulation electrodes of the diaphragm pacing device 400 are invasive electrodes or non-invasive electrodes, and the way in which the diaphragm pacing device 400 stimulates the target location includes at least one of the following: current stimulation, voltage stimulation, and magnetic stimulation.
  • the target location stimulated by the stimulating electrode includes at least one of the following: phrenic nerve, diaphragm, and abdominal muscle.
  • the processor 330 can control the diaphragm pacing device 400 to send a stimulation signal to the diaphragm of the ventilated subject during the inspiratory phase of the respiratory cycle to stimulate diaphragm contraction; and to send a stimulation signal to the abdominal muscles of the ventilated subject during the expiratory phase of the respiratory cycle. , stimulate abdominal muscle contraction.
  • the processor 330 controls the ventilation parameters of mechanical ventilation and the stimulation intensity of diaphragm pacing by: acquiring physiological state parameters representing the physiological state of the ventilated subject, and the physiological state parameters include ventilation-related parameters acquired by the sensor 310 Monitor parameters; obtain a ventilation target that provides mechanical ventilation to the ventilated subject; based on the physiological state parameters and the ventilation target, set the intensity of the diaphragm pacing stimulation signal sent to the target position of the ventilated subject, and set the mechanical ventilation for the ventilated subject parameter.
  • the monitoring parameters acquired through the sensor 310 include: monitored pressure, flow, volume and/or time of ventilation, and/or derived from at least one of pressure, flow, volume and/or time of ventilation. parameters.
  • the physiological state parameters also include: at least one of blood oxygen, blood pressure, carbon dioxide, heart rate, diaphragm electromyography, transdiaphragmatic pressure, esophageal pressure, electrical impedance, ultrasound and blood gas related parameters.
  • Ventilation parameters for mechanical ventilation of the ventilated subject include: at least one of pressure, flow, volume and/or time of mechanical ventilation provided by the ventilation device, respiratory ratio, respiratory rate, triggering mode, triggering sensitivity, and/or by ventilation Parameters derived from at least one of the pressure, flow, volume and/or time, respiratory ratio, respiratory rate, trigger mode, and trigger sensitivity of mechanical ventilation provided by the device.
  • the processor 330 calculates ventilation parameters for mechanical ventilation based on physiological state parameters and ventilation targets, the strength of the diaphragm pacing stimulation signal, and/or. Further, the processor 330 can perform closed-loop control on the intensity of the diaphragm pacing stimulation signal and/or the ventilation parameters of mechanical ventilation to achieve the ventilation target. For example, the processor 330 may coordinately adjust the stimulation intensity of the signal and the ventilation parameters to achieve the ventilation target.
  • the processor 330 can maintain the ventilation parameters unchanged and achieve the ventilation target by adjusting the intensity of the stimulation signal.
  • the ventilation parameters can be maintained at a value required to achieve positive end-expiratory pressure, or the ventilation parameters can be maintained at a value required to provide respiratory drive.
  • the processor 330 may maintain the intensity of the stimulation signal unchanged and adjust the ventilation parameters to achieve the ventilation target.
  • the processor 330 controls the ventilation parameters of mechanical ventilation and the stimulation intensity of diaphragm pacing to make the airway pressure of the ventilated subject less than the set pressure to reduce lung damage caused by mechanical ventilation.
  • the ventilation target includes a tidal volume target or a spontaneous breathing intensity target.
  • the processor 330 achieves the expected tidal volume by controlling the ventilation parameters of mechanical ventilation and the stimulation intensity of diaphragm pacing; when the tidal volume target is used, the processor 330 controls the ventilation parameters of mechanical ventilation and diaphragm pacing The stimulation intensity of the pulse achieves the expected intensity of spontaneous breathing.
  • the spontaneous breathing cycle of the ventilated subject can be determined based on the breathing parameters related to spontaneous breathing, and the intensity of the diaphragm pacing stimulation signal and the ventilation parameters of mechanical ventilation can be controlled according to the spontaneous breathing cycle to achieve the ventilation goal. Thereby enhancing human-machine synchronization.
  • the intensity of the stimulation signal for diaphragm pacing and the ventilation parameters of mechanical ventilation can be controlled according to the set respiratory cycle to achieve the ventilation goal.
  • the ventilation device 300 in the embodiment of the present application uses the ventilation device's processor to cooperatively control the diaphragm pacing device and the ventilation device, thereby reducing or avoiding lung damage or circulation suppression caused by mechanical ventilation and preventing disuse atrophy of the diaphragm.
  • the disclosed devices and methods can be implemented in other ways.
  • the device embodiments described above are only illustrative.
  • the division of the units is only a logical function division. In actual implementation, there may be other division methods.
  • multiple units or components may be combined or can be integrated into another device, or some features can be ignored, or not implemented.
  • Various component embodiments of the present application may be implemented in hardware, or in software modules running on one or more processors, or in a combination thereof.
  • a microprocessor or a digital signal processor (DSP) may be used in practice to implement some or all functions of some modules according to embodiments of the present application.
  • DSP digital signal processor
  • the present application may also be implemented as a device program (eg, computer program and computer program product) for performing part or all of the methods described herein.
  • Such a program implementing the present application may be stored on a computer-readable medium, or may be in the form of one or more signals. Such signals may be downloaded from an Internet website, or provided on a carrier signal, or in any other form.

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Abstract

一种控制通气设备的方法(100)、通气系统和通气设备，该方法(100)包括：获取表示通气对象的生理状态的生理状态参数，生理状态参数包括与通气相关的监测参数(S110)；获取为通气对象提供机械通气的通气目标(S120)；基于生理状态参数与通气目标，设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数，以对通气对象进行膈肌起搏和机械通气(S130)。通过对膈肌起搏与机械通气协同控制，能够减小或避免机械通气引起的肺损伤或循环抑制，防止膈肌废用性萎缩。

Description

控制通气设备的方法、通气系统和通气设备
说明书
技术领域
本申请涉及医疗设备技术领域，更具体地涉及一种控制通气设备的方法、通气系统和通气设备。
背景技术
机械通气治疗常用于为重症病人或麻醉手术病人进行通气支持。对于重症病人来说，呼吸衰竭是最常见的器官功能衰竭，严重威胁病人的生命安全。麻醉手术中的病人丧失了自主呼吸能力，因此也需要机械通气支持。
目前的机械通气主要是正压通气。正常人呼吸时，呼吸肌肉收缩，导致胸腔压力降低，进而引起肺内压力降低，低于大气压，此时大气中的气体就可以进入肺内形成吸气。呼气时呼吸肌肉放松，肺内压力大于外部大气压，进而可以呼出气体。而正压通气与其相反，主要由呼吸机或麻醉机等通气设备提供全部或部分呼吸驱动力，吸气时通过阀门送出气体，气道压力大于肺内压力，进而气体可以进入肺内，呼气时通过阀门释放气体，气道压力小于肺内压力，进而气体可以呼出。
由于正压通气的反生理特性，在为病人提供通气支持的同时，也会对病人的呼吸系统和循环系统产生一定的损伤。例如，正压通气压力过高可能导致肺的压力伤，潮气量过大可能导致容积伤等。由于正压通气导致胸腔内压力上升，对心脏产生压迫作用，导致右心前负荷增大等，进而影响心输出量等，导致循环的抑制。长时间的机械通气也会导致膈肌等呼吸肌肉的废用性萎缩，从而导致病人难以脱机等。
膈肌起搏技术是通过有创或无创的方式对膈神经或膈肌进行电刺激，用来增加膈肌的活动能力，进而改善呼吸。该治疗手段主要用于康复科，如脊髓损伤的病人。但对于重症病人或麻醉病人，其无法提供氧气支持，并且无法给予呼气末正压(Positive End-expiratory Pressure，PEEP)支持。
发明内容
在发明内容部分中引入了一系列简化形式的概念，这将在具体实施方式部分中进一步详细说明。本申请的发明内容部分并不意味着要试图限定出所要求保护的技术方案的关键特征和必要技术特征，更不意味着试图确定所要求保护的技术方案的保护范围。
本申请实施例第一方面提供了一种控制通气设备的方法，包括：
获取表示通气对象的生理状态的生理状态参数，所述生理状态参数包括与通气相关的监测参数；
获取为所述通气对象提供机械通气的通气目标；
基于所述生理状态参数与所述通气目标，设置向所述通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，以对所述通气对象进行膈肌起搏和机械通气。
本申请实施例第二方面提供一种通气系统，所述通气系统包括：
通气设备，包括：
传感器，用于获取通气对象的与通气相关的监测参数；
呼吸回路，用于将气源提供的气体输送给所述通气对象以进行机械通气；
膈肌起搏设备，用于通过刺激电极接触所述通气对象的目标位置，并对所述目标位置发送刺激信号，从而对所述通气对象进行膈肌起搏；
处理器，连接所述通气设备和所述膈肌起搏设备，用于设置所述机械通气的通气参数和设置所述膈肌起搏的刺激信号的强度。
本申请实施例第三方面提供一种通气设备，包括：
传感器，用于获取表示通气对象的与通气相关的监测参数；
呼吸回路，用于将气源提供的气体输送给所述通气对象以进行机械通气；
通信模块，用于与膈肌起搏设备通信连接；所述膈肌起搏设备用于通过刺激电极接触所述通气对象的目标位置，并对所述目标位置发送刺激信号，从而为所述通气对象提供膈肌起搏；
处理器，用于控制所述机械通气的通气参数和所述膈肌起搏的刺激强度。
根据本申请实施例的控制通气设备的方法、通气系统和通气设备将通气设备的正压通气与膈肌起搏产生的负压通气相结合，能够在机械通气中降低正压通气的压力，进而降低胸腔压力，减小或避免机械通气引起的肺损伤或循环抑制，同时通过对膈肌的刺激，使其产生收缩，能够减少膈肌废用性萎缩，避免对通气设备产生依赖。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
在附图中：
图1示出根据本申请一实施例的控制通气设备的方法的示意性流程图；
图2示出根据本申请一实施例的通气系统的示意性框图；
图3示出根据本申请一实施例的通气设备的示意性框图。
具体实施方式
为了使得本申请的目的、技术方案和优点更为明显，下面将参照附图详细描述根据本申请的示例实施例。显然，所描述的实施例仅仅是本申请的一部分实施例，而不是本申请的全部实施例，应理解，本申请不受这里描述的示例实施例的限制。基于本申请中描述的本申请实施例，本领域技术人员在没有付出创造性劳动的情况下所得到的所有其它实施例都应落入本申请的保护范围之内。
在下文的描述中，给出了大量具体的细节以便提供对本申请更为彻底的理解。然而，对于本领域技术人员而言显而易见的是，本申请可以无需一个或多个这些细节而得以实施。在其他的例子中，为了避免与本申请发生混淆，对于本领域公知的一些技术特征未进行描述。
应当理解的是，本申请能够以不同形式实施，而不应当解释为局限于这里提出的实施例。相反地，提供这些实施例将使公开彻底和完全，并且将本申请的范围完全地传递给本领域技术人员。
在此使用的术语的目的仅在于描述具体实施例并且不作为本申请的限制。在此使用时，单数形式的“一”、“一个”和“所述/该”也意图包括复数形式，除非上下文清楚指出另外的方式。还应明白术语“组成”和/或“包括”，当在该说明书中使用时，确定所述特征、整数、步骤、操作、元件和/或部件的存在，但不排除一个或更多其它的特征、整数、步骤、操作、元件、部件和/或组的存在或添加。在此使用时，术语“和/或”包括相关所列项目的任何及 所有组合。
为了彻底理解本申请，将在下列的描述中提出详细的结构，以便阐释本申请提出的技术方案。本申请的可选实施例详细描述如下，然而除了这些详细描述外，本申请还可以具有其他实施方式。
下面，将参考图1描述根据本申请一个实施例的控制通气设备的方法。图1是本申请实施例的控制通气设备的方法100的一个示意性流程图。
如图1所示，本申请实施例的控制通气设备的方法100包括如下步骤：
在步骤S110，获取表示通气对象的生理状态的生理状态参数，所述生理状态参数包括与通气相关的监测参数；
在步骤S120，获取为所述通气对象提供机械通气的通气目标；
在步骤S130，基于所述生理状态参数与所述通气目标，设置向所述通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，以对所述通气对象进行膈肌起搏和机械通气。
本申请实施例的控制通气设备的方法100基于通气对象的生理状态参数与通气目标控制膈肌起搏的刺激强度和机械通气的通气参数，将机械通气与膈肌起搏产生的负压通气相结合，能够在机械通气中降低正压通气的压力，进而降低胸腔压力，减小或避免机械通气引起的肺损伤或循环抑制，同时通过对膈肌的刺激，使其产生收缩，能够减少膈肌废用性萎缩，避免对通气设备产生依赖。
具体地，机械通气是由通气设备所提供的，通气设备可以实现为呼吸机、麻醉机、氧疗机等具有机械通气功能的医疗设备。接受机械通气和膈肌起搏的通气对象具体可以指因呼吸功能衰竭或自主呼吸困难而需要辅助呼吸的伤病患者。示例性地，通气设备至少包括传感器和呼吸回路，传感器用于获取与通气相关的监测参数，呼吸回路用于将气源提供的气体输送给通气对象以进行机械通气，气源提供的气体可以是空气或空气与氧气的混合气体。
膈肌起搏是由膈肌起搏设备提供的，膈肌起搏设备可以实现为通气设备的模块，例如膈肌起搏设备可以是通气设备的插件式模块、外挂式模块或内置集成式模块。膈肌起搏设备也可以实现为独立设备。在一些实施例中，膈肌起搏设备既可以独立工作，也可以作为模块集成到通气设备中。
膈肌起搏设备通过刺激电极接触通气对象的目标位置，并对所述目标位置发送刺激信号，从而对通气对象进行膈肌起搏。膈肌起搏设备的刺激方式 可以是有创方式或无创方式。其中，有创方式包括在通气对象体内植入刺激电极，或者通过体表插入电极针进行刺激；无创方式包括通过体表电极进行电刺激，或者通过感应线圈进行磁刺激等。
示例性地，膈肌起搏设备所刺激的目标位置包括以下至少一个：膈神经、膈肌、腹肌。其中，膈肌是主要的呼吸肌，膈肌收缩会引起横膈下降，从而使胸腔全方位扩展，肺内压降低，从而使外部气体进入肺内。膈肌舒张时膈肌顶部回升，胸腔容积缩小，肺回缩，从而使肺内气体排出。膈神经是支配膈肌运动的神经，刺激膈神经可使膈肌收缩。腹肌同样是参与主动呼气的主要肌群，能够改变腹内压，从而协助排空肺内气体。
示例性地，以无创方式对膈神经和腹肌进行刺激时，膈神经刺激电极用于刺激支配膈肌运动的膈神经，使膈肌收缩和舒张，膈神经参考电极用于与膈神经刺激电极形成回路；腹肌刺激电极用于刺激腹肌，使腹肌收缩和舒张，腹肌参考电极用于与腹肌刺激电极形成回路。需要说明的是，刺激电极的位置、数量等仅作为示例，本申请实施例对膈肌起搏设备的具体结构不做限制。
本申请实施例的控制通气设备的方法100由处理器实现，处理器可以是通气设备的处理器，膈肌起搏设备的处理器，或其他与通气设备和膈肌起搏设备通信连接的外部设备的处理器。处理器在通气过程中，获取为所述通气对象提供机械通气的通气目标，并获取表示通气对象的生理状态的生理状态参数，作为机械通气与膈肌起搏协同控制的依据，根据表示通气对象的生理状态的生理状态参数和机械通气的通气目标，设置机械通气的通气参数和膈肌起搏的刺激信号的强度，对通气设备和膈肌起搏设备进行协同控制，最终使通气目标得以实现。
其中，生理状态参数至少包括与通气相关的监测参数。与通气相关的监测参数可以由通气设备的传感器采集。当控制通气设备的方法100由通气设备的处理器实现时，可以由通气设备的处理器在通气过程中通过通气设备的传感器采集与通气相关的监测参数。当控制通气设备的方法100由膈肌起搏设备或第三方设备的处理器实现时，可以通过与通气设备之间的通信连接获取通气设备的传感器采集的与通气相关的监测参数。示例性地，与通气相关的监测参数可以包括监测得到的通气的压力、流量、容积以及时间中的至少一项，也可以包括从通气的压力、流量、容积以及时间中的至少一种衍生得到的参数，例如反映压力或流量变化特征的参数等。
除了与通气相关的监测参数以外，生理状态参数还可以包括能够反映通气对象的生理状态的其他参数，例如血氧、血压、二氧化碳、心率、膈肌电、跨膈压、食道压、电阻抗、超声和血气相关的参数中的至少一种。上述生理状态参数可以由通气设备采集，也可以来自与处理器通信连接的其他医疗设备，例如，心率、血压、血氧等参数可以来自监护仪，超声参数可以来自超声设备等。这部分生理参数能够从侧面反映机械通气和膈肌起搏对通气对象的生理状态产生的影响，从而辅助决策对机械通气和膈肌起搏的控制。
基于所获取到的通气对象的生理状态参数和通气目标，可以对通气设备和膈肌起搏设备进行协同控制，以实现该通气目标。示例性地，为通气对象提供机械通气的通气目标包括潮气量目标或自主呼吸强度目标。潮气量目标为在通气过程中期望达到的潮气量，自主呼吸强度目标为在通气过程中期望达到的自主呼吸强度。当通气目标为潮气量目标时，通过设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数，以实现潮气量目标。当通气目标为自主呼吸强度目标时，通过设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数，以实现自主呼吸强度目标。
其中，机械通气的通气参数包括通气设备提供的机械通气的压力、流量、容积、时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种，通气参数还可以包括由通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种衍生得到的参数。通气参数还可以包括能够控制压力、流量等的器件相关的参数，或其他任何能够影响机械通气的参数。
膈肌起搏设备的刺激信号的强度与膈肌起搏的刺激方式有关。示例性地，膈肌起搏设备对目标位置产生刺激的方式包括以下至少一种：电流刺激、电压刺激和磁刺激。当采用电流刺激时，通过调整刺激电流的大小来调整刺激强度；当采用电压刺激时，通过调整刺激电压的大小来调整刺激强度。磁刺激主要是通过脉冲磁场作用于神经系统，改变皮质神经细胞的膜电位，使之产生感应电流，产生神经电活动，当采用磁刺激时，可以通过调整脉冲磁场的强度来调整刺激强度。
示例性地，当检测到通气对象的自主呼吸时，所获取的生理状态参数还包括与通气对象的自主呼吸相关的呼吸参数，用于反映通气对象的自主呼吸 状态。与自主呼吸相关的呼吸参数包括压力、流速等，例如，可以通过吸气端和呼气端流量的差异来判断通气对象是否存在自主呼吸，或者检测呼吸回路内压力的变化判断通气对象是否存在自主呼吸。
当确定通气对象存在自主呼吸时，可以根据自主呼吸相关的呼吸参数确定通气对象的自主呼吸周期，并根据自主呼吸周期控制膈肌起搏的刺激信号的强度和机械通气的通气参数，以实现通气目标。例如，通气对象主动吸气，引起气道内的压力下降或流速变化，当感知到通气对象的吸气动作时开始送气，并对膈肌进行刺激以使膈肌收缩，从而使通气对象的主动吸气、机械通气的送气和膈肌起搏同步，避免产生人机对抗，减轻通气对象的不适感，避免可能产生的并发症。由于本申请实施例对机械通气和膈肌起搏协同控制，因而能够利用通气设备识别到的自主呼吸周期对膈肌起搏进行控制，确保膈肌起搏、机械通气与自主呼吸的同步性。
反之，对于无自主呼吸的通气对象来说，当未检测到通气对象的自主呼吸时，可以按照设定呼吸周期控制膈肌起搏的刺激信号的强度和机械通气的通气参数，以实现通气目标，并保证膈肌起搏的负压通气与机械通气的正压通气之间的同步性。
在进行膈肌起搏时，呼吸周期的不同阶段施加刺激的位置不同。具体地，在呼吸周期的吸气阶段，对通气对象的膈肌发送刺激信号；在呼吸周期的呼气阶段，对通气对象的腹肌发送刺激信号。需要说明的是，对通气对象的膈肌发送刺激信号包括对膈肌发送刺激信号，也包括对膈神经发送刺激信号具体地，可以吸气阶段向用于刺激膈神经的膈神经刺激电极输出膈神经刺激信号，在呼气阶段向腹肌刺激电极输出腹肌刺激信号，通气对象的膈肌在膈神经刺激电极的刺激下收缩，从而产生吸气的驱动力，增加吸气潮气量；通气对象的腹肌在腹肌刺激电极的刺激下收缩，从而产生呼气驱动力，增大呼气流速。
在通气过程中，膈肌起搏通过如上所述的刺激方式提供至少部分的呼吸驱动；通气设备至少需要提供预设氧浓度的气体，并实现呼气末正压，以弥补膈肌起搏无法提供不同氧浓度的呼吸气体以及无法提供呼气末正压的不足。通气的潮气量可以由膈肌起搏和正压通气共同实现，膈肌起搏和正压通气所贡献的比例可以任意设置或配置。在一些实施例中，可以基于生理状态参数与通气目标，计算向通气对象的目标位置发送的膈肌起搏刺激信号的强度， 以及计算对通气对象的机械通气的通气参数，即刺激信号的强度和通气参数均通过计算获得；在其他实施例中，刺激信号的强度和通气参数中的任意一个也可以是固定值。
在一些实施例中，在设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数时，可以对膈肌起搏刺激信号的强度和机械通气的通气参数中的至少一个进行闭环控制，以实现通气目标。闭环控制即持续地检测与通气目标相关的参数，根据检测参数与通气目标之间的偏差调整刺激信号的强度和/或通气参数，以确保在通气过程中持续地实现通气目标。在闭环控制过程中，可以对刺激信号的刺激强度和通气参数进行协同调节，以实现通气目标；或者，也可以调节刺激强度和通气参数之一。
例如，在通气过程中，可以维持通气参数不变，通过调节刺激信号的强度以实现通气目标。其中，维持通气参数不变可以包括将通气参数维持在实现呼气末正压所需的数值，即通气设备只负责提供预设氧浓度的呼吸气体，以及保证呼气末正压，呼吸驱动全部由膈肌起搏实现，从而增加膈肌的活动能力。或者，也可以将通气参数维持在提供呼吸驱动所需的数值，即由通气设备负责承担一部分的呼吸驱动，膈肌起搏和通气设备承担的呼吸驱动的比例可以任意设置，具体可以由处理器自动设置或根据用户指令进行设置。
或者，在设置膈肌起搏的刺激信号的强度以及机械通气的通气参数时，也可以维持膈肌起搏的刺激信号的强度不变，通过调节通气参数以实现通气目标。在该实施例中，由膈肌起搏承担一部分呼吸驱动，通气设备负责提供呼吸气体，保证呼气末正压，以及承担剩余的呼吸驱动，通过调节通气参数，实现潮气量目标或自主呼吸强度目标等通气目标。
在根据生理状态参数设置膈肌起搏的刺激信号的强度以及机械通气的通气参数时，可以通过调整刺激信号的强度和/或机械通气的通气参数，使通气对象的气道压力小于设定压力。减小气道压力即减小胸腔内压力，能够避免造成肺压力伤，并且能够减轻胸腔压力对心脏产生的压迫作用，避免增大心脏负荷或影响循环。设定压力可以是固定的压力值，或者，也可以根据通气对象的生理状态参数对设定压力进行调整。
综上所述，根据本申请实施例的控制通气设备的方法100将膈肌起搏与机械通气相结合，在提供机械通气的同时通过膈肌起搏降低胸腔压力，减小 或避免机械通气引起的肺损伤或循环抑制，同时由于在接受机械通气的同时膈肌也会产生一定程度的收缩，因而能够防止膈肌废用性萎缩，避免呼吸机依赖。
本申请实施例另一方面提供一种通气系统，参见图2，通气系统200包括通气设备210、膈肌起搏设备220和处理器230，通气设备210包括：传感器，用于获取与通气相关的监测参数；呼吸回路，用于将气源提供的气体输送给通气对象以进行机械通气；膈肌起搏设备220用于通过刺激电极接触通气对象的目标位置，并对目标位置发送刺激信号，从而对通气对象进行膈肌起搏；处理器230连接通气设备210和膈肌起搏设备220，用于设置机械通气的通气参数和设置膈肌起搏的刺激信号的强度。通气系统200可以用于实现上文所述的控制通气设备的方法100，以下仅对通气系统200的主要功能进行描述，其他具体细节可以参见上文。
示例性地，通气设备210可以实现为呼吸机、麻醉机、氧疗机等具有机械通气功能的医疗设备。通气设备210的呼吸回路与气源接口和通气控制单元连接，用于在通气控制单元的控制下将气源接口提供的气体输送给通气对象。气源接口向通气对象提供的气体可以是氧气，也可以是空气与氧气的混合气体。传感器包括但不限于用于测量流速信号的流速传感器，以及用于测量压力信号的压力传感器等。
示例性地，膈肌起搏设备220的刺激电极为有创式电极或无创式电极，膈肌起搏设备220对目标位置产生刺激的方式包括以下至少一种：电流刺激、电压刺激和磁刺激。刺激电极刺激的目标位置包括以下至少一个：膈神经、膈肌、腹肌。示例性地，处理器230可以控制膈肌起搏设备220在呼吸周期的吸气阶段对通气对象的膈肌发送刺激信号，刺激膈肌收缩，提供吸气驱动；在呼吸周期的呼气阶段对通气对象的腹肌发送刺激信号，刺激腹肌收缩，提供呼气驱动。
处理器230可以是通气设备210的处理器，膈肌起搏设备220的处理器，或与通气设备210和膈肌起搏设备220通信连接的第三方设备的处理器。处理器230可以通过软件、硬件、固件或其任意组合来实现，可以使用电路、单个或多个专用集成电路、单个或多个通用集成电路、单个或多个微处理器、单个或多个可编程逻辑器件、或者前述电路和/或器件的任意组合、或者其他适合的电路或器件。并且处理器230可以控制通气设备210、膈肌起搏设备220或第三方设备中的其它组件以执行期望的功能。
在一个实施例中，通气系统200还包括通信模块，用于在通气设备210与处理器230之间、或在处理器230与膈肌起搏设备220之间建立通信连接，处理器230通过通信连接控制膈肌起搏设备和/或通气设备。例如，当处理器230为通气设备210的处理器时，通信模块210用于在处理器230与膈肌起搏设备220之间建立通信连接，处理器230通过该通信连接控制膈肌起搏设备220。反之，当处理器230为膈肌起搏设备220的处理器时，通信模块210用于在处理器230与通气设备210之间建立通信连接，处理器230通过该通信连接控制通气设备220。
在一些实施例中，处理器230通过如下方式控制机械通气的通气参数和膈肌起搏的刺激强度：获取表示通气对象的生理状态的生理状态参数，生理状态参数包括传感器获取的与通气相关的监测参数；获取为通气对象提供机械通气的通气目标；基于生理状态参数与通气目标，设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数。
示例性地，通过传感器获取的监测参数包括：监测得到的通气的压力、流量、容积和/或时间，和/或从通气的压力、流量、容积和/或时间中的至少一种衍生得到的参数。除了与通气相关的监测参数之外，生理状态参数还包括：血氧、血压、二氧化碳、心率、膈肌电、跨膈压、食道压、电阻抗、超声和血气相关的参数中的至少一种。对通气对象的机械通气的通气参数包括：通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种，和/或由通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种衍生得到的参数。
在一些实施例中，处理器230基于生理状态参数与通气目标，膈肌起搏刺激信号的强度，和/或计算机械通气的通气参数。进一步地，处理器230可以对膈肌起搏刺激信号的强度和/或机械通气的通气参数进行闭环控制，以实现通气目标。例如，处理器230可以对信号的刺激强度和通气参数进行协同调节，以实现通气目标。
在控制机械通气的通气参数和膈肌起搏的刺激强度时，处理器230可以维持通气参数不变，通过调节刺激信号的强度以实现通气目标。其中，可以将通气参数维持在实现呼气末正压所需的数值，或者，将通气参数维持在提供呼吸驱动所需的数值。或者，处理器230可以维持刺激信号的强度不变，通过调节通气参数以实现通气目标。
在对通气对象进行机械通气时，处理器230通过控制机械通气的通气参数和膈肌起搏的刺激强度，使通气对象的气道压力小于设定压力，以减轻机械通气引起的肺损伤。
示例性地，通气目标包括潮气量目标或自主呼吸强度目标。当采用潮气量目标时，处理器230通过控制机械通气的通气参数和膈肌起搏的刺激强度实现预期的潮气量；当采用潮气量目标时，处理器230通过控制机械通气的通气参数和膈肌起搏的刺激强度实现预期的自主呼吸强度。
当检测到通气对象的自主呼吸时，可以根据自主呼吸相关的呼吸参数确定通气对象的自主呼吸周期，根据自主呼吸周期控制膈肌起搏刺激信号的强度和机械通气的通气参数，以实现通气目标，从而增强人机同步性。当未检测到通气对象的自主呼吸时，可以按照设定呼吸周期控制膈肌起搏的刺激信号的强度和机械通气的通气参数，以实现通气目标。
本申请实施例的通气系统200通过处理器对膈肌起搏设备与通气设备协同控制，能够减小或避免机械通气引起的肺损伤或循环抑制，防止膈肌废用性萎缩。
本申请实施例另一方面提供一种通气设备，该通气设备可以实现上述的控制通气设备的方法100。继续参见图3，本申请实施例的通气设备300包括：传感器310，用于获取通气对象的与通气相关的监测参数；呼吸回路320，用于将气源提供的气体输送给通气对象以进行机械通气；通信模块340，用于与膈肌起搏设备400通信连接；膈肌起搏设备400用于通过刺激电极接触通气对象的目标位置，并对目标位置发送刺激信号，从而为通气对象提供膈肌起搏；处理器330，用于控制机械通气的通气参数和膈肌起搏的刺激强度。
其中，通气设备300可以实现为呼吸机、麻醉机、氧疗机等具有机械通气功能的医疗设备。通信模块340提供的通信连接可以是有线连接或无线连接。处理器330通过通信模块340提供的通信连接控制膈肌起搏设备400提供的膈肌起搏的刺激强度。
示例性地，膈肌起搏设备400的刺激电极为有创式电极或无创式电极，膈肌起搏设备400对目标位置产生刺激的方式包括以下至少一种：电流刺激、电压刺激和磁刺激。刺激电极刺激的目标位置包括以下至少一个：膈神经、膈肌、腹肌。示例性地，处理器330可以控制膈肌起搏设备400在呼吸周期的吸气阶段对通气对象的膈肌发送刺激信号，刺激膈肌收缩；在呼吸周期的呼气阶段对通气对象的腹肌发送刺激信号，刺激腹肌收缩。
在一些实施例中，处理器330通过如下方式控制机械通气的通气参数和 膈肌起搏的刺激强度：获取表示通气对象的生理状态的生理状态参数，生理状态参数包括传感器310获取的与通气相关的监测参数；获取为通气对象提供机械通气的通气目标；基于生理状态参数与通气目标，设置向通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对通气对象的机械通气的通气参数。
示例性地，通过传感器310获取的监测参数包括：监测得到的通气的压力、流量、容积和/或时间，和/或从通气的压力、流量、容积和/或时间中的至少一种衍生得到的参数。除了与通气相关的监测参数之外，生理状态参数还包括：血氧、血压、二氧化碳、心率、膈肌电、跨膈压、食道压、电阻抗、超声和血气相关的参数中的至少一种。对通气对象的机械通气的通气参数包括：通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种，和/或由通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种衍生得到的参数。
在一些实施例中，处理器330基于生理状态参数与通气目标，膈肌起搏刺激信号的强度，和/或计算机械通气的通气参数。进一步地，处理器330可以对膈肌起搏刺激信号的强度和/或机械通气的通气参数进行闭环控制，以实现通气目标。例如，处理器330可以对信号的刺激强度和通气参数进行协同调节，以实现通气目标。
在控制机械通气的通气参数和膈肌起搏的刺激强度时，处理器330可以维持通气参数不变，通过调节刺激信号的强度以实现通气目标。其中，可以将通气参数维持在实现呼气末正压所需的数值，或者，将通气参数维持在提供呼吸驱动所需的数值。或者，处理器330可以维持刺激信号的强度不变，通过调节通气参数以实现通气目标。
在对通气对象进行机械通气时，处理器330通过控制机械通气的通气参数和膈肌起搏的刺激强度，使通气对象的气道压力小于设定压力，以减轻机械通气引起的肺损伤。
示例性地，通气目标包括潮气量目标或自主呼吸强度目标。当采用潮气量目标时，处理器330通过控制机械通气的通气参数和膈肌起搏的刺激强度实现预期的潮气量；当采用潮气量目标时，处理器330通过控制机械通气的通气参数和膈肌起搏的刺激强度实现预期的自主呼吸强度。
当检测到通气对象的自主呼吸时，可以根据自主呼吸相关的呼吸参数确定通气对象的自主呼吸周期，根据自主呼吸周期控制膈肌起搏刺激信号的强 度和机械通气的通气参数，以实现通气目标，从而增强人机同步性。当未检测到通气对象的自主呼吸时，可以按照设定呼吸周期控制膈肌起搏的刺激信号的强度和机械通气的通气参数，以实现通气目标。
本申请实施例的通气设备300通过通气设备的处理器对膈肌起搏设备与通气设备协同控制，能够减小或避免机械通气引起的肺损伤或循环抑制，防止膈肌废用性萎缩。
尽管这里已经参考附图描述了示例实施例，应理解上述示例实施例仅仅是示例性的，并且不意图将本申请的范围限制于此。本领域普通技术人员可以在其中进行各种改变和修改，而不偏离本申请的范围和精神。所有这些改变和修改意在被包括在所附权利要求所要求的本申请的范围之内。
本领域普通技术人员可以意识到，结合本文中所公开的实施例描述的各示例的单元及算法步骤，能够以电子硬件、或者计算机软件和电子硬件的结合来实现。这些功能究竟以硬件还是软件方式来执行，取决于技术方案的特定应用和设计约束条件。专业技术人员可以对每个特定的应用来使用不同方法来实现所描述的功能，但是这种实现不应认为超出本申请的范围。
在本申请所提供的几个实施例中，应该理解到，所揭露的设备和方法，可以通过其它的方式实现。例如，以上所描述的设备实施例仅仅是示意性的，例如，所述单元的划分，仅仅为一种逻辑功能划分，实际实现时可以有另外的划分方式，例如多个单元或组件可以结合或者可以集成到另一个设备，或一些特征可以忽略，或不执行。
在此处所提供的说明书中，说明了大量具体细节。然而，能够理解，本申请的实施例可以在没有这些具体细节的情况下实践。在一些实例中，并未详细示出公知的方法、结构和技术，以便不模糊对本说明书的理解。
类似地，应当理解，为了精简本申请并帮助理解各个发明方面中的一个或多个，在对本申请的示例性实施例的描述中，本申请的各个特征有时被一起分组到单个实施例、图、或者对其的描述中。然而，并不应将该本申请的方法解释成反映如下意图：即所要求保护的本申请要求比在每个权利要求中所明确记载的特征更多的特征。更确切地说，如相应的权利要求书所反映的那样，其发明点在于可以用少于某个公开的单个实施例的所有特征的特征来解决相应的技术问题。因此，遵循具体实施方式的权利要求书由此明确地并入该具体实施方式，其中每个权利要求本身都作为本申请的单独实施例。
本领域的技术人员可以理解，除了特征之间相互排斥之外，可以采用任何组合对本说明书(包括伴随的权利要求、摘要和附图)中公开的所有特征以及如此公开的任何方法或者设备的所有过程或单元进行组合。除非另外明确陈述，本说明书(包括伴随的权利要求、摘要和附图)中公开的每个特征可以由提供相同、等同或相似目的的替代特征来代替。
此外，本领域的技术人员能够理解，尽管在此所述的一些实施例包括其它实施例中所包括的某些特征而不是其它特征，但是不同实施例的特征的组合意味着处于本申请的范围之内并且形成不同的实施例。例如，在权利要求书中，所要求保护的实施例的任意之一都可以以任意的组合方式来使用。
本申请的各个部件实施例可以以硬件实现，或者以在一个或者多个处理器上运行的软件模块实现，或者以它们的组合实现。本领域的技术人员应当理解，可以在实践中使用微处理器或者数字信号处理器(DSP)来实现根据本申请实施例的一些模块的一些或者全部功能。本申请还可以实现为用于执行这里所描述的方法的一部分或者全部的装置程序(例如，计算机程序和计算机程序产品)。这样的实现本申请的程序可以存储在计算机可读介质上，或者可以具有一个或者多个信号的形式。这样的信号可以从因特网网站上下载得到，或者在载体信号上提供，或者以任何其他形式提供。
应该注意的是上述实施例对本申请进行说明而不是对本申请进行限制，并且本领域技术人员在不脱离所附权利要求的范围的情况下可设计出替换实施例。在权利要求中，不应将位于括号之间的任何参考符号构造成对权利要求的限制。本申请可以借助于包括有若干不同元件的硬件以及借助于适当编程的计算机来实现。在列举了若干装置的单元权利要求中，这些装置中的若干个可以是通过同一个硬件项来具体体现。单词第一、第二、以及第三等的使用不表示任何顺序。可将这些单词解释为名称。
以上所述，仅为本申请的具体实施方式或对具体实施方式的说明，本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本申请的保护范围之内。本申请的保护范围应以权利要求的保护范围为准。

Claims (20)

  1. 一种控制通气设备的方法，其特征在于，所述方法包括：
    获取表示通气对象的生理状态的生理状态参数，所述生理状态参数包括与通气相关的监测参数；
    获取为所述通气对象提供机械通气的通气目标；
    基于所述生理状态参数与所述通气目标，设置向所述通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，以对所述通气对象进行膈肌起搏和机械通气。
  2. 根据权利要求1所述的方法，其特征在于，还包括：
    基于所述生理状态参数与所述通气目标，计算向所述通气对象的目标位置发送的膈肌起搏刺激信号的强度，和/或计算对所述通气对象的机械通气的通气参数。
  3. 根据权利要求1所述的方法，其特征在于，所述设置向所述通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，包括：
    对所述膈肌起搏刺激信号的强度和/或所述机械通气的通气参数进行闭环控制，以实现所述通气目标。
  4. 根据权利要求1所述的方法，其特征在于，所述设置向所述通气对象的目标位置发送的膈肌起搏的刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，包括：
    维持所述通气参数不变，通过调节所述刺激信号的强度以实现所述通气目标。
  5. 根据权利要求4所述的方法，其特征在于，所述维持所述通气参数不变，包括：
    将所述通气参数维持在实现呼气末正压所需的数值，或者，将所述通气参数维持在提供呼吸驱动所需的数值。
  6. 根据权利要求1所述的方法，其特征在于，所述设置向所述通气对象的目标位置发送的膈肌起搏刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，包括：
    维持所述刺激信号的强度不变，通过调节所述通气参数以实现所述通气目标。
  7. 根据权利要求3所述的方法，其特征在于，对所述膈肌起搏的刺激信号的强度和/或所述机械通气的通气参数进行闭环控制，以实现所述通气目标， 包括：
    对所述信号的刺激强度和所述通气参数进行协同调节，以实现所述通气目标。
  8. 根据权利要求1-7中任一项所述的方法，其特征在于，在对所述通气对象进行机械通气时，使所述通气对象的气道压力小于设定压力。
  9. 根据权利要求1-8中任一项所述的方法，其特征在于，所述通气目标包括潮气量目标或自主呼吸强度目标。
  10. 根据权利要求1-9中任一项所述的方法，其特征在于，当检测到所述通气对象的自主呼吸时，所述生理状态参数还包括与所述通气对象的自主呼吸相关的呼吸参数；
    所述设置向所述通气对象的目标位置发送的膈肌起搏刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，包括：
    根据所述自主呼吸相关的呼吸参数确定所述通气对象的自主呼吸周期，根据所述自主呼吸周期控制所述膈肌起搏刺激信号的强度和所述机械通气的通气参数，以实现所述通气目标。
  11. 根据权利要求1-9中任一项所述的方法，其特征在于，所述设置向所述通气对象的目标位置发送的膈肌起搏刺激信号的强度，以及设置对所述通气对象的机械通气的通气参数，包括：
    当未检测到所述通气对象的自主呼吸时，按照设定呼吸周期控制所述膈肌起搏的刺激信号的强度和所述机械通气的通气参数，以实现所述通气目标。
  12. 根据权利要求10或11所述的方法，其特征在于，所述向所述通气对象的目标位置发送膈肌起搏的刺激信号，包括：
    在呼吸周期的吸气阶段对所述通气对象的膈肌发送刺激信号；
    在呼吸周期的呼气阶段对所述通气对象的腹肌发送刺激信号。
  13. 根据权利要求1所述的方法，其特征在于，所述监测参数包括：监测得到的通气的压力、流量、容积和/或时间，和/或从所述通气的压力、流量、容积和/或时间中的至少一种衍生得到的参数；
    所述生理状态参数还包括：血氧、血压、二氧化碳、心率、膈肌电、跨膈压、食道压、电阻抗、超声和血气相关的参数中的至少一种；
    所述通气参数包括：通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种，和/或由所述通气设备提供的机械通气的压力、流量、容积和/或时间、呼吸比、呼吸率、触发方式、触发灵敏度中的至少一种衍生得到的参数。
  14. 一种通气系统，其特征在于，所述通气系统包括：
    通气设备，包括：
    传感器，用于获取通气对象的与通气相关的监测参数；
    呼吸回路，用于将气源提供的气体输送给所述通气对象以进行机械通气；
    膈肌起搏设备，用于通过刺激电极接触所述通气对象的目标位置，并对所述目标位置发送刺激信号，从而对所述通气对象进行膈肌起搏；
    处理器，连接所述通气设备和所述膈肌起搏设备，用于设置所述机械通气的通气参数和设置所述膈肌起搏的刺激信号的强度。
  15. 根据权利要求14所述的通气系统，其特征在于，还包括通信模块，用于在所述通气设备与所述处理器之间、或所述处理器与所述膈肌起搏设备之间建立通信连接，所述处理器通过所述通信连接控制所述膈肌起搏设备和/或所述通气设备。
  16. 根据权利要求14所述的通气系统，其特征在于，所述膈肌起搏设备为所述通气设备的插件式模块、外挂式模块或内置集成式模块；和/或
    所述膈肌起搏设备能够独立地用于通过刺激电极接触所述通气对象的目标位置，并对所述目标位置发送刺激信号，从而对所述通气对象进行膈肌起搏。
  17. 根据权利要求14所述的通气系统，其特征在于，所述目标位置包括以下至少一个：膈神经、膈肌、腹肌。
  18. 根据权利要求14所述的通气系统，其特征在于，所述刺激电极为有创式电极或无创式电极。
  19. 根据权利要求14所述的通气系统，其特征在于，所述膈肌起搏设备对所述目标位置产生刺激的方式包括以下至少一种：电流刺激、电压刺激和磁刺激。
  20. 一种通气设备，其特征在于，包括：
    传感器，用于获取表示所述通气对象生理状态的生理状态参数，所述生理状态参数包括与通气相关的监测参数；
    呼吸回路，用于将气源提供的气体输送给所述通气对象以进行机械通气；
    通信模块，用于与膈肌起搏设备通信连接；所述膈肌起搏设备用于通过刺激电极接触所述通气对象的目标位置，并对所述目标位置发送刺激信号，从而为所述通气对象提供膈肌起搏；
    处理器，用于控制所述机械通气的通气参数和所述膈肌起搏的刺激强度。
PCT/CN2022/096321 2022-05-31 2022-05-31 控制通气设备的方法、通气系统和通气设备 WO2023230868A1 (zh)

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