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WO2024251144A1 - Appareils, systèmes et procédés de transmission de gaz thérapeutique - Google Patents

Appareils, systèmes et procédés de transmission de gaz thérapeutique Download PDF

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Publication number
WO2024251144A1
WO2024251144A1 PCT/CN2024/097474 CN2024097474W WO2024251144A1 WO 2024251144 A1 WO2024251144 A1 WO 2024251144A1 CN 2024097474 W CN2024097474 W CN 2024097474W WO 2024251144 A1 WO2024251144 A1 WO 2024251144A1
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WO
WIPO (PCT)
Prior art keywords
gas
therapeutic
therapeutic gas
section
storage section
Prior art date
Application number
PCT/CN2024/097474
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English (en)
Inventor
Yuyan ZHANG
Wangkun ZHANG
Xianghai KONG
Yuan Li
Fei Wang
Original Assignee
Nanjing Novlead Biotechnology Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202310660438.1A external-priority patent/CN119075100A/zh
Priority claimed from CN202410444278.1A external-priority patent/CN118253003A/zh
Application filed by Nanjing Novlead Biotechnology Co., Ltd. filed Critical Nanjing Novlead Biotechnology Co., Ltd.
Publication of WO2024251144A1 publication Critical patent/WO2024251144A1/fr

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Classifications

    • 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
    • A61M16/0057—Pumps therefor
    • 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
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B21/00—Nitrogen; Compounds thereof
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0808—Condensation traps
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • 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
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M16/1015—Preparation of respiratory gases or vapours with O2 features or with parameter measurement using a gas flush valve, e.g. oxygen flush valve
    • 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
    • A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
    • A61M16/125—Diluting primary gas with ambient air
    • 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A61M16/203—Proportional
    • 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A61M16/209—Relief valves
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0266—Nitrogen (N)
    • A61M2202/0275—Nitric oxide [NO]
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3341—Pressure; Flow stabilising pressure or flow to avoid excessive variation
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B21/00—Nitrogen; Compounds thereof
    • C01B21/20—Nitrogen oxides; Oxyacids of nitrogen; Salts thereof
    • C01B21/24—Nitric oxide (NO)

Definitions

  • This present disclosure relates to the field of medical device technology, particularly to a therapeutic gas transmission system that delivers the therapeutic gas on demand.
  • Inhalation therapy involves supplying therapeutic gases to patients through devices such as ventilators to achieve therapeutic effects.
  • nitric oxide (NO) gas nitric oxide
  • NO nitric oxide
  • nitric oxide has been found in recent years to play a role in transmitting important signals and regulating cell functions in the human body. It can help promote blood circulation within the body. Nitric oxide can rapidly diffuse through biological membranes without any intermediary mechanisms, transmitting information produced by one cell to the surrounding cells. Nitric oxide has various biological functions, readily participating in electron transfer reactions and the body's oxidation-reduction processes.
  • nitric oxide inhalation therapy is widely used in neonatal respiratory medicine and is also applicable in critical care, cardiothoracic surgery, respiratory internal medicine, anesthesiology, and other clinical medical fields.
  • Therapeutic gases like nitric oxide are usually used in conjunction with respiratory equipment such as ventilators and anesthesia machines.
  • the gases are transmitted to the inhalation pipeline of these devices and then inhaled by the patients for gas inhalation therapy.
  • Breath-following therapeutic gas transmission is a preferred method of delivering therapeutic gases, as it involves transmitting the therapeutic gases in accordance with the patient's breath flow rate (i.e., the delivery of therapeutic gases is synchronized with the patient's breathing patterns) .
  • the breath-following approach maintains a stable concentration of inhaled therapeutic gases throughout the breathing process and significantly reduces the impact of changes in respiratory mode and parameters on the concentration of inhaled therapeutic gases.
  • breath-following Due to the constant and significant fluctuations in breath flow rate throughout the patient's breathing process, achieving breath-following often requires rapidly transmitting a specific volume of therapeutic gas in a short time. For devices that instantly generate therapeutic gases, it is challenging to ensure the instantaneously produced therapeutic gas matches the instantaneously required transmission consumption, posing a significant challenge for instant therapeutic gas generation devices to implement breath-following transmission functionality.
  • the therapeutic gas transmission apparatus and system described herein allow for perfect compatibility with ventilators from different manufacturers, different ventilator modes, and even with anesthesia machines and extracorporeal membrane oxygenation (ECMO) units. They also meet the accuracy and stability needs of therapeutic gas concentration for different populations, including adults, children, and newborns with varying tidal volumes and respiratory rates, especially in high-frequency oscillatory ventilation.
  • ECMO extracorporeal membrane oxygenation
  • a "pressure vessel” is placed downstream of the therapeutic gas generation device and upstream of the therapeutic gas transmission pipeline.
  • This pressure vessel a large-capacity gas storage tank capable of withstanding certain pressures, stores the excess generated therapeutic gas and relies on the pressure generated by the accumulated therapeutic gas inside the tank.
  • this pressure can be relied upon to output the stored therapeutic gas from the tank, compensating for the part of the consumption that the instant preparation could not produce in time.
  • This vessel-based approach has disadvantages, such as pressure fluctuations inside the storage tank when a large flow rate of therapeutic gas is required from the tank, which can affect the flow rate of the output therapeutic gas and ultimately cause deviations in the concentration of the transmitted therapeutic gas.
  • Another disadvantage is that when the storage tank's capacity is very large, therapeutic gases can accumulate inside for a long period. Taking NO as an example, NO can easily oxidize into toxic NO2, and instantly prepared NO staying too long in a large-capacity storage tank can lead to an increase in NO2 content, thereby affecting the quality of the output therapeutic gas.
  • an apparatus for generating and/or delivering therapeutic gas e.g., nitric oxide (NO) .
  • therapeutic gas e.g., nitric oxide (NO)
  • the therapeutic gas delivery apparatus may include a therapeutic gas source (1) configured to generate therapeutic gas.
  • the therapeutic gas delivery apparatus may also include a gas storage section (2) connected downstream of the therapeutic gas source (1) , the gas storage section (2) being configured to store at least part of the therapeutic gas from the therapeutic gas source (1) .
  • the therapeutic gas delivery apparatus may furthermore include a gas output section connected downstream of the gas storage section (2) , the gas output section being configured to output the therapeutic gas on demand.
  • the therapeutic gas delivery apparatus may in addition include a replenishment section (4) connected to the gas storage section (2) , the replenishment section (4) configured to supplement gas to the gas storage section (2) .
  • System may moreover include a pressure control unit (5) connected to the gas storage section (2) , configured to stabilize a pressure inside the gas storage section (2) .
  • the therapeutic gas delivery apparatus may also include a flow control unit (6) coupled to the gas output section (3) , configured to control a quantity of the therapeutic gas delivered through the gas output section (3) .
  • Implementations of the therapeutic gas delivery apparatus may include one or more of the following features.
  • the pressure control unit (5) is configured to stabilize the pressure inside the gas storage section (2) at a preset value greater than 120 centimeters of water column.
  • the gas output section is configured to deliver the therapeutic gas to a breathing apparatus, and the pressure control unit (5) is configured to keep the pressure inside the gas storage section (2) higher than a pressure in an inspiratory branch of the breathing apparatus.
  • a patient downstream of the gas output section (3) is in an exhalation phase or a flow rate of the therapeutic gas output to the patient by the gas output section (3) is less than a flow rate of the therapeutic gas provided by the therapeutic gas source (1) , at least a portion of the therapeutic gas provided by the therapeutic gas source (1) is stored into the gas storage section (2) .
  • the therapeutic gas stored in the gas storage section (2) is spontaneously output to the gas output section (3) .
  • the gas supplemented by the replenishment section (4) may include air or the therapeutic gas.
  • An inlet of the replenishment section (4) is connected to a power source, ensuring a driving force to supplement the gas into the gas storage section (2) , where the power source may include a high-pressure gas cylinder, a central gas source in a hospital, or a gas pump.
  • the pressure control unit (5) may include a backpressure valve (5a) , where the backpressure valve (5a) is configured to: when the pressure inside the gas storage section (2) exceeds a preset value, release gas in the gas storage section (2) through a relief port of the backpressure valve (5a) to stabilize the pressure inside the gas storage section (2) .
  • the pressure control unit (5) may include a combination of a pressure-reducing valve (5b) and the backpressure valve (5a) , where: the pressure-reducing valve (5b) is configured to stabilize an input pressure from the power source.
  • the pressure control unit (5) may include a valve component that provides both pressure-reducing function and backpressure function.
  • the pressure control unit (5) may include a first mass flow controller (MFC) further coupled to the replenishment section (4) to control a flow rate of gas supplemented into the gas storage section (2) by the replenishment section (4) .
  • a relief air path is configured in between the first MFC and the gas storage section (2) , where the relief air path may include a second MFC configured to control a flow rate of gas being released from the gas storage section (2) , thereby stabilizing the pressure inside the gas storage section (2) .
  • the pressure control unit (5) may include a combination of a pressure sensor and an electric control valve, where: the pressure sensor is configured to detect the pressure in the gas storage section (2) , and the electric control valve is configured to control an opening based on the detected pressure to adjust an airflow passing through the opening.
  • the electric control valve may include a solenoid valve or a proportional valve.
  • a cross-sectional area of the gas storage section (2) is between 1 mm to 4 cm, inclusive.
  • the replenishment section (4) is further connected to the therapeutic gas source (1) and configured to supplement gas to the therapeutic gas source (1) .
  • Therapeutic gas source (1) may include an electrochemical instant preparation device for electrochemically generating nitric oxide (NO)
  • the replenishment section (4) is further configured to input purging gas into the therapeutic gas source (1) for purging electrodes and carrying out the electrochemically generated NO, where the purging gas may include air or nitrogen.
  • Therapeutic gas source (1) may include an instant preparation device for generating NO using an arc method, and the replenishment section (4) is configured to input reaction gas into the therapeutic gas source (1) , where electrodes inside an reaction chamber of the therapeutic gas source 1 are used to generate NO through high-voltage electric shocks, and the generated NO is carried out by an excess portion of the reaction gas.
  • the reaction gas may include air or oxygen-nitrogen-containing gas.
  • the replenishment section (4) is configured to connect to both the gas storage section (2) and the therapeutic gas source (1) , and input the gas through a power source to both the gas storage section (2) and the therapeutic gas source (1) .
  • the replenishment section (4) may include a first replenishment section connected to the gas storage section (2) , and a second replenishment section connected to the therapeutic gas source (1) , where the first replenishment section and the second replenishment section are connected to different power sources to transport different gases into the gas storage section (2) and the therapeutic gas source (1) , respectively.
  • the first replenishment section is configured to input air into the gas storage section (2) ; and the second replenishment section is configured to input nitrogen into the therapeutic gas source (1) .
  • the therapeutic gas delivery system may further include: a second flow control unit (7) installed downstream of the therapeutic gas source (1) to control a flow rate of the therapeutic gas output from the therapeutic gas source (1) .
  • the therapeutic gas delivery system may further include: a second flow control unit (7) installed upstream of the therapeutic gas source (1) to control a flow rate of gas entering the therapeutic gas source (1) .
  • FIG. 1 is a schematic diagram of a therapeutic gas delivery apparatus, according to a first embodiment of the present disclosure.
  • FIG. 2 is a schematic diagram of a therapeutic gas delivery apparatus, according to a second embodiment of the present disclosure.
  • FIG. 3 is a schematic diagram of a therapeutic gas delivery apparatus, according to a third embodiment of the present disclosure.
  • FIG. 4 is a schematic diagram of a therapeutic gas delivery apparatus, according to a fourth embodiment of the present disclosure.
  • FIG. 5 is a schematic diagram of a therapeutic gas delivery apparatus, according to a fifth embodiment of the present disclosure.
  • FIG. 6 is a schematic diagram of an electrochemical instant preparation device, according to some embodiments of the present disclosure.
  • FIG. 7 is a schematic diagram of an arc method instant preparation device, according to some embodiments of the present disclosure.
  • FIG. 8 is a schematic diagram of a Nitric Oxide (NO) supply module in a respiratory device, according to a first embodiment of the present disclosure.
  • NO Nitric Oxide
  • FIG. 9 is a schematic diagram of the NO supply module in the respiratory device, according to a second embodiment of the present disclosure.
  • FIG. 10 is a schematic diagram of the NO supply module in the respiratory device, according to a second embodiment of the present disclosure.
  • FIG. 11 is a schematic diagram of the NO supply module in the respiratory device, according to a third embodiment of the present disclosure.
  • FIG. 12 is a schematic diagram of the NO supply module in the respiratory device, according to a fourth embodiment of the present disclosure.
  • FIG. 13 is a schematic diagram of the NO supply module in the respiratory device, according to a fifth embodiment of the present disclosure.
  • FIG. 14 is a schematic diagram of the NO supply module in the respiratory device, according to a sixth embodiment of the present disclosure.
  • FIG. 15 is a schematic diagram of the NO supply module in the respiratory device, according to a seventh embodiment of the present disclosure.
  • FIG. 16 is a schematic diagram of the NO supply module installed in the respiratory device through a mounting slot, according to some embodiments of the present disclosure.
  • FIG. 17 is a schematic diagram of NO preparation and transmission system, according to some embodiments of the present disclosure.
  • FIG. 18 is an schematic diagram of the gas storage section in the embodiments of the present disclosure.
  • FIG. 19 is another schematic diagram of the gas storage section in the embodiments of the present disclosure.
  • FIG. 20 is yet another schematic diagram of the gas storage section in the embodiments of the present disclosure.
  • FIG. 1 is a schematic diagram of a therapeutic gas delivery apparatus, according to a first embodiment of the present disclosure.
  • the therapeutic gas delivery apparatus includes a therapeutic gas source (1) , a gas storage section (2) , a gas output section (3) , a replenishment section (4) , a pressure control unit (5) , and a flow control unit (6) .
  • the therapeutic gas source (1) is used for the instant generation of therapeutic gases, such as NO, CO, H 2 S, H 2 , etc.
  • the gas storage section (2) is connected downstream of the therapeutic gas source (1) and configured to store therapeutic gas supplied by the therapeutic gas source (1) .
  • the gas output section (3) is connected downstream of the therapeutic gas source (1) , allowing the therapeutic gas to be transmitted to the patient.
  • the replenishment section (4) is connected to the gas storage section (2) , through which gas can be supplemented into the gas storage section (2) .
  • the pressure control unit (5) is connected to the gas storage section (2) , and configured to stabilize the pressure inside the gas storage section (2) at a preset value.
  • the preset value is generally greater than 120 centimeters of water column.
  • the flow control unit (6) is located on or upstream of the gas output section (3) and configured to control the quantity or flow rate of therapeutic gas being delivered to the patient.
  • the excess therapeutic gas enters the gas storage section (2) , and the gas storage section (2) stores all or part of the excess therapeutic gas.
  • the therapeutic gas stored in the gas storage section (2) spontaneously transfers to the gas output section (3) .
  • the gas supplemented by the replenishment section (4) into the gas storage section (2) can be air or therapeutic gas, etc.
  • the inlet of the replenishment section (4) may be connected to a power source, providing sufficient driving force to supplement gas into the gas storage section (2) .
  • the power source can be a high-pressure gas cylinder, a central gas source in a hospital, or a gas pump.
  • the pressure control unit (5) can be a backpressure valve.
  • the pressure control unit (5) can be a backpressure valve.
  • new therapeutic gas is introduced into the gas storage section (2) , causing the gas pressure inside the gas storage section (2) to exceed a preset value, the gas will be vented outward from the gas storage section (2) through the relief port of the backpressure valve to maintain stable pressure within the gas storage section (2) .
  • the pressure control unit (5) can include a pressure-reducing valve (5b) and a backpressure valve (5a) .
  • the pressure-reducing valve (5b) lowers and stabilizes the pressure of the input from the power source.
  • gas pressure inside the gas storage section (2) exceeds a preset value, gas is vented outward from the gas storage section (2) through the relief port of the backpressure valve (5a) to maintain stable pressure within the gas storage section (2) .
  • valve components/components may have both pressure-reducing and backpressure functions. Therefore, such a valve component (5c) can be installed on the gas storage section (4) , achieving the same effect as the pressure-reducing valve (5b) and the backpressure valve (5a) in the second embodiment.
  • the pressure control unit can also take forms such as a Mass Flow Controller (MFC) .
  • MFC Mass Flow Controller
  • a first mass flow controller may be placed on the replenishment section (4) to control the mass flow rate of gas supplemented into the gas storage section (2) .
  • a relief air path may be configured between the first mass flow controller and the gas storage section (2) , with a second mass flow controller arranged on the relief air path to control the mass flow rate of gas being vented, thereby achieving the effect of maintaining stable pressure within the gas storage section (2) .
  • the pressure control unit (5) can also be a combination of a pressure sensor and an electric control valve, such as a solenoid valve, proportional valve, etc.
  • the pressure sensor is used to detect the pressure in the gas storage section (2) , and the electric control valve adjusts its opening based on the detected pressure value to control the size of the airflow passing through. For example, if a low pressure is detected, then the airflow passing through is reduced.
  • the pressure sensor can also be located downstream of the gas storage section (2) , but the delay in detecting pressure changes due to flow adjustments made by the electric control valve may be less conducive to pressure control.
  • the pressure control unit (5) can be installed on the replenishment section (4) , or on the gas storage section (2) . It is generally not recommended to place the pressure control unit (5) near the gas output section (3) because when excess therapeutic gas is introduced into the gas storage section (2) , the pressure control unit (5) will vent some of the older gas from the gas storage section (2) to make room for the newly introduced therapeutic gas. If the placement of the pressure control unit (5) is too close to the gas output section (3) , it will reduce the actual volume of the gas storage section (2) available for storing therapeutic gas. To maximize the usable volume of the gas storage section (2) and minimize the size of the gas storage section (2) , it is preferred to install the pressure control unit (5) on the replenishment section (4) .
  • a cross-sectional area S of the gas storage section (2) ranges from 1 mm 2 to 4 cm 2 , inclusive.
  • a cross-sectional area S that is close to or below the lower limit will lead to increased air resistance, making it difficult to achieve the effect of rapid gas transmission.
  • a cross-sectional area S that is close to or exceeds the upper limit will intensify the diffusion and mixing of the therapeutic gas with the supplemented gas at their interface, affecting the concentration of the output therapeutic gas and reducing the utilization rate of the produced therapeutic gas.
  • the replenishment section (4) can also be connected to the therapeutic gas source (1) to supplement gas to the therapeutic gas source (1) .
  • the replenishment section (4) can input purging gas (air, nitrogen, etc. ) for purging the electrodes and carrying out the electrochemically generated NO gas.
  • the example electrochemical instant preparation device includes a reaction chamber (11) , which has a gas area and a liquid area.
  • the liquid area is configured to contain a reaction medium (12)
  • the gas area is configured to contain product gas including NO.
  • Electrode (13) contacts the reaction medium (12) , and by applying a predetermined current or voltage to electrode (13) , NO gas can be produced within reaction chamber (11) .
  • a purging gas inlet (14) is used to introduce purging gas into the reaction medium (12) to sweep out the NO gas produced in the reaction medium (12) , with the purging gas being air, nitrogen, etc.
  • the reaction medium (12) may include a buffer solution, a nitrite ion source, and a catalyst, where the catalyst includes a metal-ligand complex, and the nitrite ion source includes one or more types of nitrites.
  • the composition of the reaction medium (12) may refer to the content disclosed in the Chinese Patent Publication number CN114318357A, published on April 12, 2022, which discloses an electrolyte for achieving high concentration output of NO, and the corresponding electrolytic cell and electrolysis method.
  • the content of Chinese Patent Publication number CN114318357A is incorporated into this application by reference.
  • An example implementation of the electrochemical instant preparation device for generating NO may refer to the content disclosed in the Chinese patent publication number CN110831640A, published on February 21, 2020, which discloses a nitric oxide generation system for a gas delivery device.
  • the content of Chinese patent publication number CN110831640A is also incorporated into this application by reference.
  • the replenishment section (4) can input reaction gas (air, oxygen-nitrogen-containing gas, etc. ) .
  • reaction gas air, oxygen-nitrogen-containing gas, etc.
  • FIG. 7 An example instant preparation device using an arc method is illustrated in FIG. 7.
  • the instant preparation device using the arc method may include a reaction chamber (21) that contains one or more electrodes (22) .
  • the electrodes inside the reaction chamber (21) of the therapeutic gas source (1) generate NO through high-voltage electric shocks, and the produced NO is carried out by the excess reaction gas.
  • the instant preparation device may also include a reaction gas inlet (23) for introducing the reaction gas into reaction chamber (21) .
  • the reaction gas may be air.
  • Electrode (22) is configured to use a high-voltage circuit to generate product gas from the reaction gas, with the product gas containing a desired amount of NO.
  • the replenishment section (4) can be connected to both the gas storage section (2) and the therapeutic gas source (1) , inputting the same gas (such as air) through a power source to both the gas storage section (2) and the therapeutic gas source (1) .
  • two replenishment sections (4) can be set up, each connected to the gas storage section (2) and the therapeutic gas source (1) , respectively, with each of the two replenishment sections (4) connected to different power sources to transport different gases, such as inputting air into the gas storage section (2) and nitrogen into the therapeutic gas source (1) .
  • a flow control unit (7) can be installed downstream of the therapeutic gas source 1 to control the flow rate of the therapeutic gas output from the therapeutic gas source 1.
  • the flow control unit (7) can also be installed upstream of the therapeutic gas source (1) , as shown in the fifth embodiment illustrated in FIG. 5, to control the gas flow rate entering the therapeutic gas source 1.
  • FIGs. 1-7 The therapeutic gas delivery apparatus described above and illustrated in FIGs. 1-7 is distinguishable from existing NO generating and delivering systems and methods from several aspects.
  • Chinese Patent Publication No. CN110573454B describes a system and method for generating NO (e.g., paragraph [0227] and Figures 19-25 of the specification) .
  • the structures mentioned in CN110573454B include buffer tanks, pistons, diaphragms, and diaphragm drivers, forming a temporary storage and the NO gas is output through these structures.
  • the disclosed solution in CN110573454B requires a certain volume of buffer tank to store NO gas, which faces limitations on miniaturizing the device.
  • the power source for driving the output of NO gas from the gas storage section (2) is the stable pressure within the gas storage section (2) .
  • the medium for driving the output of NO gas is the supplementary gas filled into the gas storage section (2) through the replenishment section (4) (the interface between the supplementary gas and the NO gas inside the gas storage section (2) can be approximately considered as a piston) .
  • the output process of NO gas inside the gas storage section (2) there is no need for signal transmission or other forms of control.
  • the output can be instantaneously achieved through pressure reliance.
  • using the supplementary gas as the medium during the output process eliminates friction and wear.
  • the therapeutic gas delivery apparatus described herein has at least the following technical benefits. Firstly, it is capable of achieving breath-following gas output with a sufficiently small device size.
  • the miniaturization and lightweight design significantly reduce the limitations imposed by therapeutic settings, facilitating easier integration with other treatment devices.
  • the therapeutic gas delivery apparatus described herein does not require complex electromagnetic components or signal transmission for control coordination, eliminating the presence of wear parts. This aspect contributes to the high reliability and immediacy of the apparatus.
  • the apparatus described in this disclosure demonstrates a shorter rise time when outputting therapeutic gas.
  • the initial phase involves mixing NO gas with air until an even mixture is achieved before the output concentration of NO can stabilize.
  • the apparatus described herein uses a gas storage section-based system with a smaller diameter and volume. This design allows for a quick expulsion of the original gas inside the storage section upon the introduction of NO gas, resulting in a rapid adjustment to the desired NO concentration within one to two breathing cycles. This leads to a shorter concentration rise period and a faster response speed, highlighting the efficiency and responsiveness of the described therapeutic gas delivery apparatus.
  • the therapeutic gas delivery apparatus described in FIGs. 1-7 may be incorporated into a respiratory device or a system as a nitric oxide (NO) supply module.
  • the following description illustrate an example respiratory device (FIGs. 8-16) and an example respiratory system (FIG. 17) .
  • breath-following therapeutic gas output requires the ability to rapidly inject a certain flow rate of therapeutic gas based on the respiratory rate, flow, and pressure of devices such as ventilators and anesthesia machines.
  • the flow rate may need to reach over 120L/min in a short period.
  • a gas storage container may be configured upstream of the therapeutic gas input pipeline with a certain pressure and capacity. This gas storage container stores therapeutic gas at the appropriate times and releases the stored therapeutic gas when the inhalation flow rate increases rapidly in a short period, compensating for any shortfall in the instant preparation and transmission flow rate of the therapeutic gas unit.
  • the therapeutic gas delivery apparatus described in FIGs. 1-7 may be adopted, as a nitric oxide (NO) supply module in a respiratory device.
  • NO nitric oxide
  • the NO supply module may include a housing (1000) .
  • the housing (1000) may include a reaction chamber (81) with an inlet (810) and an outlet (811) .
  • the reaction chamber (81) may further include electrodes (812) .
  • the inlet (810) allows the reaction gas flow (typically air) to enter, and the electrodes (812) enable the reaction gas flow passing through the reaction chamber (81) to generate nitric oxide product gas, with the outlet (811) releasing the airflow containing the product gas.
  • the housing (1000) may further include a gas storage section (82) , located downstream of the outlet (811) .
  • the gas storage section (82) is configured to store at least part of the product gas from the outlet (811) at certain times.
  • the housing (1000) may further include a gas transmission section (83) , located downstream of the outlet (811) .
  • the gas transmission section (83) is configured to export the airflow containing the product gas outside the housing (1000) .
  • the housing (1000) may further include a power source (84) coupled to the gas storage section (82) to maintain a stable internal gas pressure within the gas storage section (82) .
  • the excess gas is directed into the gas storage section (82) to store at least part of this excess gas.
  • the gas stored inside the gas storage section (82) is directed towards the gas transmission section (83) .
  • the housing (1000) may be designed as a detachable assembly incorporated into a respiratory device (2000) .
  • the housing (1000) may be equipped with a gas transmission interface (1001) , which connects to the gas transmission section (83) .
  • the respiratory device (2000) may feature an interface that compatibly connects with the gas transmission interface (1001) and is linked to the inhalation branch (2001) of the respiratory device (2000) .
  • the housing (1000) is equipped with an air intake interface (1002) .
  • the respiratory device (2000) features an interface that connects compatibly with the air intake interface (1002) , and this interface is connected to the internal airway of the respiratory device (2000) .
  • the inlet (810) of the reaction chamber (81) is connected to the air intake interface (1002) , supplying the reaction gas flow to the reaction chamber (81) through the internal airway of the respiratory device (2000) .
  • the gas storage section (82) is also connected to the air intake interface (1002) , receiving gas through the internal airway of the respiratory device (2000) , in which the air intake interface (1002) serves as the power source (84) .
  • the power source (84) in FIG. 8 includes a pressure control device (85) , which is used to maintain the stable internal gas pressure within the gas storage section (82) .
  • the pressure control device (85) can be a pressure-reducing valve with a relief function (effectively integrating the functions of a backpressure valve and a pressure-reducing valve into one unit) , or it can be a combination of a pressure-reducing valve and a backpressure valve as shown in Figure 4 of Chinese Patent Publication No. CN2023106604381, or it can be a set of cooperating mass flow controllers as shown in Figure 9 of Chinese Patent Publication No. CN2023106604381.
  • FIG. 9 is a schematic diagram of the NO supply module in the respiratory device, according to a second embodiment of the present disclosure.
  • the housing (1000) is also equipped with an air intake interface (1002) .
  • the respiratory device (not shown in FIG. 9, see 2000 in FIG. 8) features an interface that connects compatibly with the air intake interface (1002) , and this interface is connected to the internal airway of the respiratory device.
  • the inlet (810) of reaction chamber (81) is connected to the air intake interface (1002) , which supplies the reaction gas flow to the reaction chamber (81) through the internal airway of the respiratory device.
  • the power source (84) includes a gas pump (840) located within the housing (1000) .
  • This gas pump (840) is connected to the gas storage section (82) and is used to supply gas to the gas storage section (82) . Furthermore, the power source also includes a pressure control device (85) , which may use the same pressure control device from the first embodiment (as shown in FIG. 8) .
  • FIG. 10 is a schematic diagram of the NO supply module in the respiratory device, according to a third embodiment of the present disclosure.
  • the housing (1000) is equipped with an air intake interface (1002) .
  • the respiratory device (not shown in FIG. 9, see 2000 in FIG. 8) features an interface that matches and connects with the air intake interface (1002) , and this interface is linked to the internal airway of the respiratory device.
  • the inlet (810) of the reaction chamber (81) is connected to the air intake interface (1002) , which supplies the reaction gas flow to the reaction chamber (81) through the internal airway of the respiratory device.
  • the housing (1000) in FIG. 10 also has a gas supply interface (1003) .
  • the respiratory device is equipped with an interface that matches and connects with the gas supply interface (1003) , and this interface is connected to the internal airway of the respiratory device.
  • the gas storage section (82) is connected to the gas supply interface (1003) , which supplies gas to the gas storage section (82) through the internal airway of the respiratory device and serves as the power source (84) .
  • the power source (84) may also include a pressure control device (85) from the first and second embodiments.
  • FIG. 11 is a schematic diagram of the NO supply module in the respiratory device, according to a fourth embodiment of the present disclosure.
  • the housing (1000) does not have an air intake interface (e.g., 1002 in FIGs. 8-10) or a gas supply interface (e.g., 1003 in FIGs. 8-10) .
  • a first gas pump (8100) Within the housing (1000) , there is a first gas pump (8100) , and the inlet (810) of the reaction chamber (81) is connected to this first gas pump (8100) , which supplies the reaction gas flow to the reaction chamber (81) .
  • the power source (84) includes a second gas pump (840) located within the housing (1000) . This second gas pump (840) is connected to the gas storage section (82) , and the pump is used to supply gas to the gas storage section (82) . Furthermore, the power source (84) also includes a pressure control device (85) from the previously described embodiments.
  • FIG. 12 is a schematic diagram of the NO supply module in the respiratory device, according to a fifth embodiment of the present disclosure.
  • the housing (1000) does not have an air intake interface (e.g., 1002 in FIGs. 8-10) or a gas supply interface (e.g., 1003 in FIGs. 8-10) .
  • Inside the housing (1000) there is a second gas pump (8100) , with the inlet (810) of reaction chamber (81) connected to this second gas pump (8100) , which supplies the reaction gas flow to the reaction chamber (81) .
  • the gas storage section (82) is also connected to the second gas pump (8100) , which supplies gas to the gas storage section (82) , thereby serving as the power source (84) .
  • the power source (84) includes a pressure control device (85) from the previously described embodiments.
  • FIG. 13 is a schematic diagram of the NO supply module in the respiratory device, according to a sixth embodiment of the present disclosure.
  • the housing (1000) does not have an air intake interface (1002) .
  • a gas pump (8100) Inside the housing (1000) , there is a gas pump (8100) , with the inlet (810) of the reaction chamber (81) connected to this gas pump (8100) , which supplies the reaction gas flow to the reaction chamber (81) .
  • the housing (1000) is equipped with a gas supply interface (1003) .
  • the respiratory device (not shown in FIG. 9, see 2000 in FIG. 8) features an interface that matches and connects with the gas supply interface (1003) , and this interface is connected to the internal airway of the respiratory device.
  • the gas storage section (82) is connected to the gas supply interface (1003) , which supplies gas to the gas storage section (82) through the internal airway of the respiratory device, thereby serving as the power source (84) .
  • the power source (84) includes a pressure control device (85) from the previously described embodiments.
  • the gas storage section (82) may include at least one gas storage passage (820) .
  • the gas storage passage (820) may have a sufficiently small cross-sectional area to minimize the dispersion phenomenon between gases (i.e., reduce the dispersion at the interface between nitric oxide gas stored in the gas storage passage (820) and air input by the power source) .
  • the cross-sectional area S of the gas storage passage may be configured with in the range of 1mm 2 ⁇ S ⁇ 4cm 2 .
  • the power source (84) may be in the form of a piston cylinder, and the gas storage section (82) is integrated into the piston cylinder.
  • the controlling of the pressure in the gas storage section (82) is achieved by driving the piston rod to change the volume of the space in the gas storage section (82) .
  • this piston cylinder structure has some drawbacks: 1) Volume impact -the internal space of the module housing is limited, and the form of the piston cylinder might cause an increase in the overall volume of the module; 2) Reliability -the piston rod of the piston cylinder requires frequent repetitive driving actions, which poses a challenge to its reliability; 3) Delay -the timing of driving the piston rod needs to be controlled by signal feedback, which can lead to delays, resulting in the internal pressure of the gas storage section (82) not matching the desired pressure and affecting the accuracy of nitric oxide output; 4) Noise; 5) Power consumption.
  • the power source (84) may be in the form of a gas bag.
  • the gas storage section (82) may use a gas bag structure capable of expansion and contraction, functioning as the power source (84) .
  • the force to recover the deformation of the gas bag structure serves as the power source.
  • This method also has certain drawbacks, such as fatigue and wear from the repeated deformation of the gas bag, leading to a limited service life.
  • a first flow control device (86) (as the example shown in FIG. 8 but applicable to all described embodiments) is installed on the upstream pipeline connected to the inlet (810) of the reaction chamber (81) to control the flow of reaction gas entering the reaction chamber (81) .
  • the first flow control device (86) may be a Mass Flow Controller (MFC) .
  • a second flow control device (87) (as the example shown in FIG. 8 but applicable to all described embodiments) may be installed, which controls the flow rate of the outgoing gas stream.
  • the second flow control device (87) may also be a Mass Flow Controller (MFC) .
  • a filtration device (88) may be installed on the gas transmission section (83) to filter NO2 from the product gas.
  • the filtration device (88) is detachably connected to the gas transmission section (83) .
  • the filtration device (88) has an inlet and an outlet, each connected to the gas transmission section (83) .
  • the filtration device (88) is located on the exterior of the housing (1000) .
  • An interface for the inlet and outlet of the filtration device (88) to be plugged in is provided on the housing (1000) , with the internal interface of the housing (1000) connecting to the gas transmission section (83) .
  • the filtration device (88) can be installed on the interior side of the housing (1000) , close to the wall of the housing (1000) , with a removable operation window provided at the corresponding position of the filtration device (88) on the housing (1000) .
  • the filtration device (88) is a consumable, and its filtering material (e.g., calcium hydroxide) may need to be replaced periodically as its use time increases. Placing the filtration device (88) on the exterior of the housing (1000) or close to the wall of the housing (1000) facilitates replacement. Preferably, the filtration device (88) is installed upstream of the second flow control device (87) . Placing it upstream helps ensure the effectiveness of breath-following because the filtration device (88) has a filter chamber filled with filtering material.
  • filtering material e.g., calcium hydroxide
  • the flow rate and timeliness of the therapeutic gas output through the second flow control device (87) and passing through the filter chamber may be affected, thereby impacting the effectiveness of breath-following.
  • a detection branch (89) is installed on the gas transmission section (83) , with one end connected to the gas transmission section (83) and the other end open to the environment.
  • the detection branch (89) is used to measure the concentration of nitric oxide in the gas transmission section (83) .
  • the detection branch (89) includes an air resistance (890) and a nitric oxide sensor (891) arranged in sequence from closer to further away from the gas transmission section (83) .
  • the air resistance may be set up to prevent a large amount of gas from escaping to the environment through the detection branch (89) , allowing only a small amount of gas to pass through to the sensor.
  • the detection branch (89) in the example shown in FIG. 8 is positioned upstream of the second flow control device (87) and downstream of the filtration device (88) .
  • the detection branch (89) is placed as close as possible upstream of the second flow control device (87) to ensure that the NO concentration monitored is as close as possible to the actual output concentration. If the detection branch (89) is placed downstream of the second flow control device (87) , it would be difficult for the therapeutic gas to enter the detection branch (89) , likely resulting in the inability to detect the concentration of the therapeutic gas. Placing the detection branch (89) upstream of the filtration device (88) would result in a lower actual output concentration of NO.
  • the NO supply module illustrated in FIGs. 8-13 may further include a sampling detection unit (3000) , which includes a detection gas pathway (3100) located within the housing (1000) and a sampling gas pathway (3200) located outside the housing (1000) .
  • the detection gas pathway (3100) is connected to the sampling gas pathway (3200) .
  • one end of the sampling gas pathway (3200) is connected to the inhalation branch (2001) of the respiratory device (2000) , and the other end is connected to the detection gas pathway (3100) inside the housing (1000) through a water trap (3201) .
  • the water trap (3201) is a primarily intended to filter moisture from the sampling gas to prevent damage to downstream sensors or affect the detection results.
  • the water trap (3201) needs to be removed periodically, so it is located on the exterior of the housing (1000) , and the housing (1000) is equipped with a mounting base for installing the water trap (3201) .
  • one end of the detection gas pathway (3100) is connected to the water trap (3201) , and the other end is open to the environment.
  • the detection gas pathway (3100) is equipped with a sampling gas pump (3101) and a sensor unit (3102) .
  • the sampling gas pump (3101) provides the sampling power
  • the sensor unit (3102) can include sensors such as a nitric oxide sensor, nitrogen dioxide sensor, oxygen sensor, etc., to detect components like NO, NO 2 , O 2 , etc., in the gas that the patient is about to inhale.
  • the sampling detection unit (3000) is optional in the NO supply module, as shown in the embodiments illustrated in FIGs. 14 and 15, which do not include the sampling detection unit (3000 as shown in FIG. 8) .
  • the sampling detection unit (3000 as shown in FIG. 8) can be an independent module assembled with the respiratory device (2000 as shown in FIG. 8) .
  • the housing (1000) in FIG. 8-13 may be equipped with a fan (see 4000 in FIG. 8 as an example) .
  • the fan (4000) is located on the inner wall of the housing (1000) , and ventilation holes are provided at the position of the fan (4000) on the housing (1000) .
  • the fan (4000) can also be placed on the exterior of the housing (1000) , and its primary function is to facilitate cooling and ventilation.
  • the end of the detection branch (89) that connects to the environment is linked to the fan (4000) , thereby connecting to the external environment of the housing (1000) .
  • the end of the detection gas pathway (3100) of the sampling detection unit (3000) that connects to the environment is also linked to the fan (4000) , thereby connecting to the external environment of the housing (1000) .
  • the gas escaping to the environment through the detection branch (89) may include the product gas nitric oxide, which can easily oxidize into the toxic nitrogen dioxide. If it accumulates inside the housing (1000) , it could pose a safety hazard, so linking to the fan (4000) allows it to be expelled to the external environment as soon as possible.
  • nitric oxide and nitrogen dioxide in the detection gas pathway (3100) of the sampling detection unit (3000) is also expelled to the external environment as soon as possible through the fan (4000) .
  • the fan (4000) disperses these gases before expelling them, preventing the accumulation of NO, NO2, and other exhaust gases.
  • the fan (4000) is optional within the NO supply module (see the embodiment in FIG. 14 that does not include the fan) .
  • the pressure control device (85) when the pressure control device (85) is a pressure-reducing valve with a relief function, its relief port can also be connected to the fan (4000) via a pipeline.
  • the relief port can also be directly connected to the environment.
  • the relief port can be connected to the inlet of the filtration device (88) via a pipeline.
  • FIG. 16 is a schematic diagram of a portable NO supply device that may be installed onto a respiratory device (2000) through a mounting slot (2002) , according to some embodiments of the present disclosure.
  • the respiratory device illustrated in FIG. 16 is a portable NO supply device, in which the housing (1000) is designed to be easily portable.
  • the mounting slot (2002) is designed to install the portable NO supply device to the respiratory apparatus (2000) .
  • FIG. 17 illustrates a schematic diagram of NO preparation and transmission system, according to some embodiments of the present disclosure.
  • the NO preparation and transmission system may include an air intake unit for supplying air to the system and a reaction chamber (171) , located downstream of the air intake unit.
  • the reaction chamber may include an inlet (1710) , an outlet (1711) , and electrodes (1712) .
  • the inlet (1710) connects to the air intake unit to receive a reaction gas flow (e.g., air) , and the electrodes (1712) enable the reaction gas flow passing through the reaction chamber (171) to generate nitric oxide product gas.
  • the outlet (1711) releases the airflow containing the product gas.
  • the NO preparation and transmission system may further include a transport unit for exporting the airflow containing the product gas out of the system, the transport unit including a gas storage section (172) , a gas transmission section (173) , a supplementary gas section (174) , and a pressure control unit (175) .
  • the gas storage section (172) located downstream of the outlet (1711) , is used to store at least a part of the product gas from the outlet (1711) at certain times.
  • the gas transmission section (173) also located downstream of the outlet (1711) , is used to export the airflow containing the product gas out of the system.
  • the supplementary gas section (174) one end connected to the air intake unit and the other end connected to the gas storage section (172) , is used to supplement gas to the gas storage section (172) .
  • the pressure control unit (175) is connected to the gas storage section (172) and is used to maintain the pressure inside the gas storage section (172) at a preset value.
  • One end of the supplementary gas section (174) may also be connected to an independent air intake unit to achieve the supplementary gas function.
  • the air intake unit may include one or more components.
  • the air intake unit may include an air intake filter, which filters particulates, VOCs, etc., from the air to prevent damage to internal components (such as air pumps) of the device, or from being inhaled by patients.
  • the air intake unit may further include an air pump (which can be a diaphragm pump or other types of booster pumps) . This pump draws air from the environment into the device, providing an air gas source for generating NO in reaction chamber (171) and also supplying a pressurized gas source for the system.
  • the air intake unit may further include an air gas container, which aims to reduce fluctuations in the pulsating airflow produced by the air pump, stabilizing the air flow and the pressure produced by the air intake unit.
  • the air pump provides a pressurized gas source, it may also produce water. If water enters the system, it could affect the production of NO therapeutic gas in the arc reaction chamber (171) , as well as potentially affect the system's filters in absorbing NO 2 .
  • an air dehumidification unit could be added. This dehumidification unit could be placed upstream of the air pump, but water may be generated again after passing through the air pump. The dehumidification unit could be placed downstream of the air gas container, but liquid water may have already formed downstream, requiring treatment of the liquid water at a higher cost. Therefore, the dehumidification unit is preferably located between the air pump and the air gas container to quickly reduce the humidity of the compressed gas source.
  • This dehumidification method could be a Nafion tube or other methods of filtering water or water vapor.
  • the air intake unit may also include a backpressure valve to prevent pipe burst when the pressure of the air intake unit is too high, and a pressure sensor could be added to detect the pressure of the air intake unit. If the pressure is too high, it could stop or reduce the air extraction.
  • the excess gas when the flow rate exported by the gas transmission section (173) outside the system is less than the flow rate supplied by the outlet (1711) to the gas transmission section (173) , the excess gas enters the gas storage section (172) , where at least a part of this excess gas is stored. Conversely, when the flow rate that needs to be exported by the gas transmission section (173) outside the system exceeds the flow rate provided by the outlet (1711) to the gas transmission section (173) , the gas stored within the gas storage section (172) is directed towards the gas transmission section (173) .
  • the pressure control unit (175) can be a pressure-reducing valve with a relief function (effectively integrating the backpressure valve function and pressure-reducing valve function into one unit) , or it can be a combination of a pressure-reducing valve and a backpressure valve (as shown in Figure 4 of Chinese Patent Publication CN2023106604381) , or it can be a set of cooperating mass flow controllers (as shown in Figure 9 of Chinese Patent Publication CN2023106604381) .
  • the gas storage section (172) includes at least one gas storage passage (1720) .
  • the gas storage passage (1720) has a sufficiently small cross-sectional area to minimize the dispersion between gases (i.e., to reduce the dispersion at the interface where the nitric oxide gas stored in the gas storage passage (1720) meets the air input from the power source) .
  • the cross-sectional area of the gas storage passage is less than 20cm 2 , preferably less than 4cm 2 , and more preferably less than 1cm 2 .
  • the ports for input/output of nitric oxide gas in the gas storage section (172) are located at one end of the gas storage passage (1720) , while the ports for connecting to the power source (174) are situated at the other end of the gas storage passage (1720) .
  • the air intake unit is connected to the inlet (1710) of reaction chamber (171) via a pipeline equipped with a first flow control device (176) , which regulates the flow of reaction gas entering reaction chamber (171) .
  • the first flow control device (176) can also be positioned downstream of the outlet (1711) of reaction chamber (171) .
  • the first flow control device (176) may be a Mass Flow Controller (MFC) .
  • the transport unit may further include a second flow control device (177) , located on the gas transmission section (3) , to regulate the flow rate of the outgoing airflow.
  • the second flow control device (177) may also be a Mass Flow Controller (MFC) .
  • the transport unit may further include a filtration device (178) , positioned on the gas transmission section (173) , designed to filter NO 2 from the product gas.
  • the filtration device (178) may be detachably connected to the gas transmission section (173) .
  • the filtration device (178) may include an inlet and an outlet, each connecting to the gas transmission section (173) .
  • the transport unit may include a detection branch (179) , situated on the gas transmission section (173) . One end of detection branch (179) connects to the gas transmission section (173) , and the other end opens to the environment, allowing for the measurement of nitric oxide concentration in the gas transmission section (173) .
  • the detection branch (179) may include an air resistance (1790) and a nitric oxide sensor one (1791) , arranged in sequence from near to far from the gas transmission section (173) .
  • the air resistance is designed to prevent a large amount of gas from escaping through detection branch (179) to the environment, allowing only a small amount of gas to pass through to the sensor.
  • the NO preparation and transmission system in FIG. 17 may further include a sampling detection unit (3000) , which may include a detection gas pathway (3100) and a sampling gas pathway (3200) .
  • the detection gas pathway (3100) is connected to the sampling gas pathway (3200) .
  • One end of the sampling gas pathway (3200) is connected to the inhalation branch (2001) of the respiratory device (2000) , while the other end connects to the detection gas pathway (3100) through a water trap (3201) .
  • the water trap (3201) is designed to filter moisture from the sampled gas to prevent damage to downstream sensors or to avoid impacting the detection results.
  • one end of the detection gas pathway (3100) connects to the water trap (3201) , and the other end opens to the environment.
  • the detection gas pathway (3100) is equipped with a sampling gas pump (3101) and a sensor unit (3102) .
  • the sampling gas pump (3101) provides the power for sampling, while the sensor unit (3102) can include sensors such as nitric oxide sensors, nitrogen dioxide sensors, oxygen sensors, etc., for detecting NO, NO 2 , O 2 , etc., in the gas that the patient is about to inhale.
  • the filtration device (178) in FIG. 17 may house several independent filtration chambers to achieve different filtering functions.
  • one filtration chamber is filled with calcium hydroxide filtering agent, connected to the gas transmission section (173) for the removal of NO 2 from the gas.
  • Another filtration chamber is filled with potassium permanganate filtering agent, used for exhaust gas removal, with its outlet connected to the environment.
  • the pressure control unit (175) is a pressure-reducing valve with a relief function
  • its relief port can also be connected via a pipeline to the filtration device (178) chamber for exhaust gas removal. This setup prevents untreated gas from being directly released into the environment when product gas is expelled from the relief port through the filtration device (178) .
  • a shut-off valve is installed upstream of the filtration device (178) .
  • the filtration device (178) reaches the end of its life, the device doesn't need to be shut down for replacement.
  • the filtration device (178) can be directly removed and replaced, and the shut-off valve immediately closes upon removal of the filtration device (178) to maintain stable internal pressure within the equipment.
  • the shut-off valve is opened by the filtration device (178) to reconnect the gas transmission section (173) and the filtration device (178) , allowing the NO therapeutic gas to be normally output.
  • This shut-off valve could also be a solenoid valve.
  • the NO preparation and transmission system in FIG. 17 may further include a pressure relief unit.
  • the pressure relief unit may include a pressure relief pipeline. One end of this pipeline can be connected between the gas storage section (172) and the pressure control unit (175) , or between the gas storage section (172) and the shut-off valve, or between the filtration device (178) and the flow control device one (176) .
  • a solenoid valve may be installed on the pressure relief pipeline. When the device stops outputting NO, opening this solenoid valve allows for the rapid expulsion of NO from the system, preventing NO from remaining in the system for extended periods where it could oxidize to NO2. This also helps to equalize the internal and external pressures of the system, extending the device's lifespan.
  • An alternative approach is to open the solenoid valve and simultaneously stop the arc after stopping NO output, using the air from the air intake unit to purge the NO gas from the system.
  • NO output is stopped, the gas pathway inside the system contains air.
  • the other end of the pressure relief pipeline may be connected to the chamber of the filtration device (178) used for removing exhaust gas.
  • the NO preparation and transmission system in FIG. 17 provides at least the following technical advantages over existing solutions:
  • Internal integrated gas source processes the humidity of the incoming air, reducing the possibility of water vapor condensing within the system, preventing corrosion of the system by acidic liquids formed when NO2 dissolves in water;
  • the shut-off valve allows for the filter to be replaced without stopping the device, without depressurizing it, and without leaking NO treatment gas, reducing the time treatment is interrupted by filter replacement.
  • a crucial requirement for the gas storage compartment is to keep the cross-sectional area of its cavity as uniform as possible. Maintaining a minimal cross-sectional area is crucial for minimizing the mixing and dispersion of fluids between adjacent sections within the container.
  • Traditional approaches such as the use of long pipes and similar pipeline configurations, tend to demand significant installation space. While strategies like winding and stacking can help optimize space utilization, they fall short when dealing with special fluids, including corrosive gases or liquids like NO, NO2, and nitric acid. For these substances, conventional hose materials are inadequate, necessitating the use of materials such as PTFE and other high-fluorine substances.
  • FIGs. 18 and 19 illustrate schematic diagrams of the gas storage section in the embodiments of the present disclosure.
  • the designs in FIGs. 18 and 19 include a compact structure with a high effective-volume ratio, corrosion-resistant materials, and minimal internal fluid mixing.
  • the structural design is to keep the interior fluid mixing and dispersion to a minimum by employing a series of continuous pipelines that maintain a uniform cross-section throughout. To optimize the volume ratio, these pipelines have a uniform thickness, and interconnections are created between adjacent channels through small perforations in their walls.
  • the aperture cross-sectional area can be made less than 1cm 2 to avoid excessive fluid diffusion.
  • Materials such as polytetrafluoroethylene (PTFE) , aluminum alloys, and stainless steel can be selected, with machining or injection molding as potential manufacturing processes.
  • honeycomb structure comprising nearly hexagonal shapes that connect efficiently, maximizing wall thickness usage between each
  • a honeycomb-like structure made of corrosion-resistant metal or plastic can be manufactured, as illustrated in FIGs. 18 and 19, with partial sidewalls between adjacent holes opened to create a continuous (approximate) cross-sectional pipeline container.
  • This structure is sealed at both ends with a mesh corrosion-resistant sealing pad and end caps, allowing for a compact volume while maintaining continuous cross-sectional pathways.
  • FIGs. 18 and 19 The difference between FIGs. 18 and 19 is the cross-sectional shape of the cavity body of the gas storage section.
  • the cross-section of each channel is designed to be elliptical, optimizing compatibility with machining tools. This approach yields the cross-sectional shapes illustrated in FIG. 18.
  • this design choice leads to a reduced efficiency in the use of wall thickness between adjacent pipelines.
  • each channel is shaped as a regular hexagon. This method ensures uniform wall thickness throughout the gas storage section's inner cavity, as depicted in FIG. 19. Such a configuration maximizes the efficiency of internal space utilization.
  • the gas storage section's end caps may be detachable, with each end sealed using a mesh sealing pad, as shown in FIG. 20.
  • the sealing pads are pressed against the ribbing (i.e., the wall thickness) between channels. Gas enters from one end, flows to the other end, and then passes back through adjacent channels opened in the sidewalls in the reverse direction, creating a serpentine flow that serially connects the entire channel unidirectionally, similar to a series of uniform wall thickness pipes tightly arranged within the structure.
  • the gas inlet and outlet can be positioned differently, but it's desirable to ensure that every channel is fully utilized.
  • the openings between adjacent channels on the sidewalls should be as close to the ends as possible to minimize dead spaces and prevent gas from lingering in these areas.
  • the size of these openings should neither be too large nor too small, ideally matching the cross-sectional area of the channels. Too large an opening can cause fluid to disperse and mix when passing through, while too small an opening can create excessive resistance, affecting the normal flow of the gas.
  • the sidewalls at both ends of the remaining channels will be opened to an adjacent channel, but not to the same adjacent channel at both ends.
  • a channel close to the container's sidewall may have an opening to the outside for a sensor installation, allowing the monitoring of internal pressure, temperature, and other conditions through the sensor installed at the opening.
  • the designs of the gas storage section illustrated in FIGs. 18 and 19 have several technical advantages.
  • these structural designs significantly enhance the efficiency of gas storage by downsizing gas container volumes. These designs achieve this by maximizing pipeline volume within a compact footprint, addressing a key challenge in the design of gas containers.
  • the structures offer a substantial reduction in the volume occupied by traditional pipeline coil methods, facilitating easy installation and secure fixation of gas containers.
  • these structures offer more choices in materials and design, making them easier to produce and manufacture.
  • the structures do not compromise on performance. It maintains key advantages such as preventing the mixing and dispersion of gases, ensuring the integrity and efficiency of gas utilization.
  • these structures in NO therapy gas delivery devices. They adeptly manage the storage and release of NO gas to address the varying demands during the respiratory cycle of a user. During exhalation, these structures temporarily store excess NO gas, and during inhalation, when the demand for NO increases, they release the stored gas. This mechanism helps balance the real-time production and consumption of NO gas, preventing the mixing and dispersion with the driving gas or its oxidation to NO 2 . Consequently, these structures enhance the safety and efficacy of nitric oxide therapy devices, broadening their scope of application.
  • the therapeutic gas delivery devices described in this document are utilized to administer NO therapy gas into a ventilator.
  • the gas is mixed prior to patient inhalation.
  • a patient with a tidal volume of 500ml who requires an inhalation concentration of 10ppm of NO would ideally receive a 1: 9 mixture of NO gas to ventilator air.
  • the therapeutic gas delivery device therefore, would need to emit 50ml of NO gas at 100ppm concentration.
  • a 35ml gas storage section within the therapeutic gas delivery device can accomplish this when maintained at an internal pressure of 0.5bar (Gauge pressure) , given that the pressure in the ventilator's inspiratory limb is comparatively lower and can be disregarded.
  • a 25ml gas storage section within the therapeutic gas delivery device can accomplish the same goal when maintained at an internal pressure of 1bar. This scenario highlights the device's compact and lightweight nature, significantly enhancing its compatibility with ventilators and other medical equipment.
  • the mixing ratio is too high in the example above, the ventilator's oxygen might be undesirably diluted.
  • a lower mixing ratio leads to less NO gas being released, which allows for a smaller gas storage section but necessitates a higher NO gas concentration from the device.
  • This demands a more sophisticated production method, especially if using electric arc techniques, which can increase NO 2 production.
  • a patient's tidal volume directly affects the required size of the gas storage section. Some individuals may have tidal volumes exceeding 1000 milliliter (ml) , or even 1500ml. In preferred embodiments, the volume of the gas storage section is designed to be less than the patient's tidal volume. Adjusting the mixing ratio, storage section pressure, and NO concentration can help minimize the volume needed for the gas storage section.
  • the gas storage section should have a volume of less than 1500ml; ideally less than 1200ml; more ideally less than 1000ml; and more ideally less than 800ml. In certain cases, a volume less than 200ml is sufficient.
  • the preferred cross-sectional area of the gas storage section ranges between 1mm 2 and 4cm 2 , inclusive; preferably below 2cm 2 , inclusive.

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Abstract

La présente divulgation concerne un dispositif d'administration de gaz thérapeutique. Le dispositif d'administration de gaz thérapeutique peut comprendre une source de gaz thérapeutique conçue pour générer un gaz thérapeutique, et une partie stockage de gaz raccordée en aval de la source de gaz thérapeutique. La partie stockage de gaz est conçue pour stocker au moins une partie du gaz thérapeutique provenant de la source de gaz thérapeutique. En outre, le dispositif peut comprendre une partie sortie de gaz raccordée en aval de la partie stockage de gaz, la partie sortie de gaz étant conçue pour émettre le gaz thérapeutique à la demande. De plus, le dispositif peut comprendre une partie réapprovisionnement raccordée à la partie stockage de gaz, la partie réapprovisionnement étant conçue pour ajouter du gaz dans la partie stockage de gaz. Le dispositif peut encore comprendre une unité de régulation de pression raccordée à la partie stockage de gaz, conçue pour stabiliser la pression à l'intérieur de la partie stockage de gaz. Enfin, le dispositif peut comprendre une unité de régulation de débit couplée à la partie sortie de gaz, conçue pour réguler la quantité de gaz thérapeutique administré par la partie sortie de gaz.
PCT/CN2024/097474 2023-06-06 2024-06-05 Appareils, systèmes et procédés de transmission de gaz thérapeutique WO2024251144A1 (fr)

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CN202310660438.1A CN119075100A (zh) 2023-06-06 2023-06-06 一种治疗气体输出系统及模组
CN202310660438.1 2023-06-06
CN202410444278.1 2024-04-12
CN202410444278.1A CN118253003A (zh) 2024-04-12 2024-04-12 治疗气体输送装置

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JP2018020138A (ja) * 2017-09-13 2018-02-08 アイ・エヌ・オー セラピューティクス エル・エル・シーＩＮＯ Ｔｈｅｒａｐｅｕｔｉｃｓ ＬＬＣ ガス送出システム
CN212347382U (zh) * 2020-03-05 2021-01-15 刘忠英 一种呼吸器
WO2021248142A2 (fr) * 2020-06-05 2021-12-09 The General Hospital Corporation Systèmes et procédés de production d'oxyde nitrique et de traitement par celui-ci
CN114470451A (zh) * 2021-12-22 2022-05-13 安徽省立医院(中国科学技术大学附属第一医院) 一种治疗仪
WO2022127902A1 (fr) * 2020-12-18 2022-06-23 Nanjing Novlead Biotechnology Co., Ltd. Appareils, systèmes et procédés de production d'oxyde nitrique
US20220211970A1 (en) * 2021-01-07 2022-07-07 L'Air Liquide, Société Anonyme pour l'Etude et l'Exploitation des Procédés Georges Claude Installation for supplying therapeutic gas to a patient while taking account of the losses of leaktightness at the mask
EP4052748A1 (fr) * 2021-03-04 2022-09-07 L'Air Liquide, société anonyme pour l'Étude et l'Exploitation des procédés Georges Claude Interface de ventilation de patient destinée à être couplée à un ventilateur médical et à une source de gaz

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018020138A (ja) * 2017-09-13 2018-02-08 アイ・エヌ・オー セラピューティクス エル・エル・シーＩＮＯ Ｔｈｅｒａｐｅｕｔｉｃｓ ＬＬＣ ガス送出システム
CN212347382U (zh) * 2020-03-05 2021-01-15 刘忠英 一种呼吸器
WO2021248142A2 (fr) * 2020-06-05 2021-12-09 The General Hospital Corporation Systèmes et procédés de production d'oxyde nitrique et de traitement par celui-ci
WO2022127902A1 (fr) * 2020-12-18 2022-06-23 Nanjing Novlead Biotechnology Co., Ltd. Appareils, systèmes et procédés de production d'oxyde nitrique
US20220211970A1 (en) * 2021-01-07 2022-07-07 L'Air Liquide, Société Anonyme pour l'Etude et l'Exploitation des Procédés Georges Claude Installation for supplying therapeutic gas to a patient while taking account of the losses of leaktightness at the mask
EP4052748A1 (fr) * 2021-03-04 2022-09-07 L'Air Liquide, société anonyme pour l'Étude et l'Exploitation des procédés Georges Claude Interface de ventilation de patient destinée à être couplée à un ventilateur médical et à une source de gaz
CN114470451A (zh) * 2021-12-22 2022-05-13 安徽省立医院(中国科学技术大学附属第一医院) 一种治疗仪

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