Therapeutic gas delivery device

Abstract

The present invention describes a therapeutic gas delivery device. The therapeutic gas delivery device may include a therapeutic gas source configured to generate therapeutic gas; and a gas storage unit connected downstream of the therapeutic gas source, the gas storage unit being configured to store at least part of the therapeutic gas from the therapeutic gas source. In addition, the device may further include a gas output unit connected downstream of the gas storage unit, the gas output unit being configured to output therapeutic gas as needed. In addition, the device may further include a gas replenishment unit connected to the gas storage unit and configured to replenish gas to the gas storage unit. In addition, the device may further include a pressure control unit connected to the gas storage unit for stabilizing the pressure inside the gas storage unit. In addition, the device may further include a flow control unit connected to the gas output unit for controlling the quantity of therapeutic gas delivered through the gas output unit.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a therapeutic gas delivery device for delivering therapeutic gas as needed. Background Art

[0002] Inhalation therapy refers to providing therapeutic gas to patients through devices such as ventilators to achieve a therapeutic effect. Taking nitric oxide (NO) gas as an example, in recent years, it has been found that nitric oxide plays an important role in transmitting signals and regulating cell functions in the human body. It helps to promote blood circulation in the body. Nitric oxide can rapidly diffuse through biological membranes without any intermediate mechanism, transmitting the information generated by one cell to surrounding cells. Nitric oxide has multiple biological functions and can participate in electron transfer reactions and the redox process of the human body at any time. Direct inhalation of nitric oxide therapy has been approved by the US Food and Drug Administration as a treatment for neonatal persistent pulmonary hypertension. This therapy has been proven to improve the body's oxygenation ability and reduce the need for critically ill patients for high-risk extracorporeal life support. Controlling and appropriately inhaling nitric oxide can effectively reduce pulmonary hypertension and improve oxygenation. Currently, nitric oxide inhalation therapy has been widely used in neonatal respiratory medicine and is also applicable to clinical medicine fields such as intensive care, cardiothoracic surgery, respiratory medicine, and anesthesiology.

[0003] Therapeutic gases such as nitric oxide are usually used in conjunction with respiratory devices such as ventilators and anesthesia machines. The therapeutic gas is transmitted to the inhalation pipeline of these devices and then inhaled by the patient for gas inhalation therapy. Respiratory-following therapeutic gas transmission is a preferred method for delivering therapeutic gas because it delivers the therapeutic gas according to the patient's respiratory flow rate (i.e., the transmission of the therapeutic gas is synchronized with the patient's breathing pattern). Compared with traditional therapeutic gas delivery methods, the respiratory-following method can maintain a stable concentration of inhaled therapeutic gas throughout the breathing process and significantly reduce the impact of changes in breathing patterns and parameters on the concentration of inhaled therapeutic gas.

[0004] Due to the continuous and significant fluctuations in respiratory flow rate during the patient's breathing process, achieving respiratory tracking usually requires rapidly delivering a specific volume of therapeutic gas within a short period of time. For devices that generate therapeutic gas immediately, it is challenging to ensure that the instantaneously generated therapeutic gas matches the instantaneously required transmission consumption, which poses a great challenge to the instant therapeutic gas generation device to achieve the respiratory-following transmission function.

[0005] The therapeutic gas delivery device described in this case can be perfectly compatible with ventilators from different manufacturers, different ventilator modes, and even anesthesia machines and extracorporeal membrane oxygenation (ECMO) devices. They can also meet the requirements of different populations for the accuracy and stability of therapeutic gas concentration, including adults, children, and neonates, with different tidal volumes and respiratory frequencies, especially during high-frequency oscillatory ventilation.

[0006] Some existing instant generation devices are designed to implement a breathing-following transmission function. As disclosed in PCT patent publication number WO2022127902A, a "pressure vessel" is placed downstream of the therapeutic gas generation device and upstream of the therapeutic gas transmission pipeline. This pressure vessel is a large-capacity gas storage tank capable of withstanding a certain pressure, used to store the excess therapeutic gas generated, and relying on the pressure generated by the therapeutic gas accumulated in the tank. In this way, when a large amount of therapeutic gas needs to be output quickly within a short time, the stored therapeutic gas can be output from the tank relying on this pressure to compensate for the part of the consumption that the instant preparation cannot generate in time.

[0007] This container-based approach has some drawbacks. For example, when a large flow rate of therapeutic gas needs to be output from the pressure vessel, there will be pressure fluctuations inside the pressure vessel, which will affect the flow rate of the output therapeutic gas, and ultimately lead to a deviation in the concentration of the transmitted therapeutic gas. The larger the capacity of the pressure vessel, the better the effect of avoiding pressure fluctuations during large-flow output, which requires the pressure vessel to be very large to ensure that the above-mentioned defects do not occur under some conventional flow rate requirements. This greatly limits the miniaturization of the device and also limits the applicable scenarios of the instant therapeutic gas generation device. Another disadvantage is that when the capacity of the pressure vessel is very large, the therapeutic gas will accumulate in the container for a long time. Taking NO as an example, NO is easily oxidized to NO2. The NO prepared instantaneously staying in the large-capacity pressure vessel for too long will cause an increase in the content of NO2, thus affecting the quality of the output therapeutic gas. Summary of the Invention

[0008] According to some embodiments of the present disclosure, there is provided a device for generating and / or delivering a therapeutic gas (such as nitric oxide (NO)).

[0009] In a general aspect, the therapeutic gas delivery device may include a therapeutic gas source configured to generate a therapeutic gas. The therapeutic gas delivery device may further include a gas storage unit connected downstream of the therapeutic gas source, the gas storage unit being configured to store at least part of the therapeutic gas from the therapeutic gas source. The therapeutic gas delivery device may further include a gas output unit connected downstream of the gas storage unit, the gas output unit being configured to output the therapeutic gas as needed. In addition, the therapeutic gas delivery device may further include a gas replenishment unit connected to the gas storage unit, the gas replenishment unit being configured to replenish gas to the gas storage unit. In addition, the device may further include a pressure control unit connected to the gas storage unit for stabilizing the pressure inside the gas storage unit. The therapeutic gas delivery device may further include a flow control unit connected to the gas output unit for controlling the amount of therapeutic gas delivered through the gas output unit.

[0010] Embodiments of the therapeutic gas delivery device may include one or more of the following features. The pressure control unit is configured to stabilize the pressure inside the gas storage unit at a preset value greater than 120 cmH₂O. The gas output unit is configured to deliver therapeutic gas to the breathing device, and the pressure control unit is configured to maintain the pressure inside the gas storage unit higher than the pressure in the inhalation branch of the breathing device. When the patient downstream of the gas output unit is in the exhalation phase, or when the flow rate of the therapeutic gas output by the gas output unit to the patient is lower than the flow rate of the therapeutic gas provided by the therapeutic gas source, at least a portion of the therapeutic gas provided by the therapeutic gas source is stored in the gas storage unit.

[0011] When the flow rate of the therapeutic gas output by the gas output unit to the patient exceeds the flow rate provided by the therapeutic gas source, the therapeutic gas stored in the gas storage unit will spontaneously output to the gas output unit.

[0012] The gas supplemented by the gas supplementing unit may include air or therapeutic gas. The inlet of the gas supplementing unit is connected to a power source to ensure the driving force for supplementing gas to the gas storage unit, where the power source may include a high-pressure gas cylinder, the central gas source of a hospital, or a gas pump.

[0013] When the gas supplementing unit is connected to the power source, the pressure control unit may include a backpressure valve, where the backpressure valve is configured to: when the pressure inside the gas storage unit exceeds the preset value, release the gas inside the gas storage unit through the pressure relief port of the backpressure valve to stabilize the pressure inside the gas storage unit.

[0014] When the power source connected to the gas supplementing unit may include a high-pressure gas cylinder or a gas pump, the pressure control unit may include a combination of a pressure reducing valve and a backpressure valve, where: the pressure reducing valve is configured to stabilize the input pressure from the power source.

[0015] The pressure control unit may include a valve component that provides both a pressure reducing function and a backpressure function. The pressure control unit may include a first mass flow controller, which is further coupled to the gas supplementing unit to control the gas flow supplemented to the gas storage unit by the gas supplementing unit. A pressure relief gas path is configured between the first mass flow controller and the gas storage unit, where the pressure relief gas path may include a second mass flow controller, which is configured to control the flow rate of the gas released from the gas storage unit, thereby stabilizing the pressure inside the gas storage unit.

[0016] The pressure control unit 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 unit, and the electric control valve is configured to control the opening according to the detected pressure to adjust the gas flow through the opening. The electric control valve may include a solenoid valve or a proportional valve.

[0017] The cross-sectional area of the gas storage unit is between 1 mm 2 and 4 cm 2Between (including). The gas supplementing part is further connected to the treatment gas source and configured to supplement gas to the treatment gas source. The treatment gas source may include an electrochemical instant preparation device for electrochemically generating nitric oxide (NO). The gas supplementing part is further configured to input a purging gas to the treatment gas source for purging the electrodes and the NO generated electrochemically, where the purging gas may include air or nitrogen.

[0018] The treatment gas source may include an instant preparation device for generating NO by the arc method. The gas supplementing part is configured to input a reaction gas to the treatment gas source. The electrode inside the reaction chamber of the treatment gas source is used to generate NO by high-voltage electric shock, and the generated NO is carried out by the excess part of the reaction gas.

[0019] The reaction gas may include air or a gas containing oxygen and nitrogen. The gas supplementing part is configured to be connected to the gas storage part and the treatment gas source simultaneously and input gas to the gas storage part and the treatment gas source by power. The gas supplementing part may include a first gas supplementing part connected to the gas storage part and a second gas supplementing part connected to the treatment gas source, where the first gas supplementing part and the second gas supplementing part are connected to different power sources and respectively transport different gases to the gas storage part and the treatment gas source.

[0020] The first gas supplementing part is configured to input air into the gas storage part; the second gas supplementing part is configured to input nitrogen into the treatment gas source.

[0021] The treatment gas delivery device may further include: a second flow control unit installed downstream of the treatment gas source to control the flow rate of the treatment gas output from the treatment gas source. The treatment gas delivery device may further include: a second flow control device installed upstream of the treatment gas source for controlling the flow rate of the gas entering the treatment gas source.

[0022] It should be understood that the above general description and the following detailed description are only exemplary and explanatory and do not limit the embodiments of the claims of the present invention.

[0023] The drawings form a part of this specification. The drawings illustrate several embodiments of the present invention and are used together with the description to explain the principles of certain disclosed embodiments described in the appended claims. Brief Description of the Drawings

[0024] Figure 1 is a schematic diagram of a treatment gas delivery device according to a first embodiment of the present disclosure.

[0025] Figure 2 is a schematic diagram of a treatment gas delivery device according to a second embodiment of the present disclosure.

[0026] Figure 3 is a schematic diagram of a treatment gas delivery device according to a third embodiment of the present disclosure.

[0027] Figure 4 It is a schematic diagram of a therapeutic gas delivery device according to the fourth embodiment of the present disclosure.

[0028] Figure 5 It is a schematic diagram of a therapeutic gas delivery device according to the fifth embodiment of the present disclosure.

[0029] Figure 6 It is a schematic diagram of an electrochemical instant preparation device according to some embodiments of the present disclosure.

[0030] Figure 7 It is a schematic diagram of an arc method instant preparation device according to some embodiments of the present disclosure.

[0031] Figure 8 It is a schematic diagram of a nitric oxide (NO) supply module in a breathing device according to the first embodiment of the present disclosure.

[0032] Figure 9 It is a schematic diagram of the NO supply module in a breathing device according to the second embodiment of the present disclosure.

[0033] Figure 10 It is a schematic diagram of the NO supply module in a breathing device according to the second embodiment of the present disclosure.

[0034] Figure 11 It is a schematic diagram of the NO supply module in a breathing device according to the third embodiment of the present disclosure.

[0035] Figure 12 It is a schematic diagram of the NO supply module in a breathing device according to the fourth embodiment of the present disclosure.

[0036] Figure 13 It is a schematic diagram of the NO supply module in a breathing device according to the fifth embodiment of the present disclosure.

[0037] Figure 14 It is a schematic diagram of the NO supply module in a breathing device according to the sixth embodiment of the present disclosure.

[0038] Figure 15 It is a schematic diagram of the NO supply module in a breathing device according to the seventh embodiment of the present disclosure.

[0039] Figure 16 It is a schematic diagram of the NO supply module installed in a breathing device through an installation groove according to some embodiments of the present disclosure.

[0040] Figure 17 It is a schematic diagram of an NO preparation and transmission system according to some embodiments of the present disclosure.

[0041] It should be recognized that some or all of the drawings are schematic representations for illustrative purposes. Detailed Implementation Modes

[0042] The disclosed embodiments will now be described in detail. Unless otherwise defined, technical or scientific terms have the meanings commonly understood by those of ordinary skill in the art. The disclosed embodiments have been described in sufficient detail to enable those skilled in the art to implement the disclosed embodiments. It should be understood that other embodiments may be used and changes may be made without departing from the scope of the disclosed embodiments. Therefore, the materials, methods, and examples are illustrative only and not necessarily restrictive.

[0043] Figure 1 is a schematic diagram of a therapeutic gas delivery device according to a first embodiment of the present disclosure. As shown in the figure, the therapeutic gas delivery device includes a therapeutic gas source 1, a gas storage unit 2, a gas output unit 3, a gas supplement unit 4, a pressure control unit 5, and a flow control unit 6.

[0044] The therapeutic gas source 1 is used to instantaneously generate therapeutic gases, such as NO, CO, H2S, H2, etc.

[0045] The gas storage unit 2 is connected downstream of the therapeutic gas source 1 and is used to store the therapeutic gas provided by the therapeutic gas source 1.

[0046] The gas output unit 3 is connected downstream of the therapeutic gas source 1 and can transmit the therapeutic gas to the patient.

[0047] The gas supplement unit 4 is connected to the gas storage unit 2, and gas can be supplemented to the gas storage unit 2 through this part.

[0048] The pressure control unit 5 is connected to the gas storage unit 2 and is used to stabilize the pressure in the gas storage unit 2 at a preset value. In some embodiments, the preset value is generally greater than 120 cmH2O. By stabilizing the pressure inside the gas storage unit 2 at the preset value, it can be ensured that the pressure inside the gas storage unit 2 is higher than the pressure of the inspiratory branch of the ventilator, so that the therapeutic gas inside the gas storage unit 2 spontaneously outputs to the ventilator pipeline. The higher the preset pressure value, the greater the maximum flow rate that the therapeutic gas delivery device can achieve, thereby improving the breathing following effect. However, the increase in the pressure value also raises the requirements for the reliability of the device.

[0049] The flow control unit 6 is located on or upstream of the gas output unit 3, and its configuration is used to control the quantity or flow rate of the therapeutic gas delivered to the patient.

[0050] When the patient downstream of the gas output unit 3 is in the exhalation phase or the amount of gas transmitted by the gas output unit 3 to the patient end is less than the amount provided by the therapeutic gas source 1, the excess therapeutic gas enters the gas storage unit 2, and the gas storage unit 2 stores all or part of the excess therapeutic gas.

[0051] When the amount of gas transmitted to the patient end by the gas output unit 3 exceeds the amount of gas provided by the treatment gas source 1, the treatment gas stored in the gas storage unit 2 spontaneously transfers to the gas output unit 3. The gas supplemented to the gas storage unit 2 by the gas supplement unit 4 can be air, treatment gas, etc. The inlet of the gas supplement unit 4 can be connected to a power source that provides sufficient driving force to supplement gas into the gas storage unit 2. For example, the power source can be a high-pressure gas cylinder, the central gas source of a hospital, or a gas pump.

[0052] The pressure control unit 5 can be implemented in various ways. As Figure 1 shown in the first embodiment, when the gas supplement unit 4 is connected to a stable and controllable power source, the pressure control unit 5 can be a backpressure valve. When new treatment gas enters the gas storage unit 2, causing the gas pressure in the gas storage unit 2 to exceed the preset value, the gas will be discharged outward from the gas storage unit 2 through the pressure relief port of the backpressure valve to maintain the pressure stability in the gas storage unit 2.

[0053] As Figure 2 shown in the second embodiment, when the power source connected to the gas supplement unit 4 is a high-pressure gas cylinder or a gas pump, the pressure control unit 5 can include a pressure reducing valve 5b and a backpressure valve 5a. The pressure reducing valve 5b can reduce and stabilize the pressure input from the power source. When the gas pressure in the gas storage unit 2 exceeds the preset value, the gas is discharged outward from the gas storage unit 2 through the pressure relief port of the backpressure valve 5a to maintain the pressure stability in the gas storage unit 2.

[0054] As Figure 3 shown in the third embodiment, some valve devices / components may have both pressure reducing and backpressure functions at the same time. Therefore, such a valve component 5c can be installed on the gas storage unit 2 to achieve the same effect as the pressure reducing valve 5b and the backpressure valve 5a in the second embodiment.

[0055] In addition to the above mechanical valve forms, the pressure control unit can also adopt forms such as a mass flow controller (MFC). For example, a first mass flow controller can be set on the gas supplement unit 4 to control the mass flow of the gas supplemented to the gas storage unit 2. A pressure relief air passage can be configured between the first mass flow controller and the gas storage unit 2, and a second mass flow controller can be arranged on the pressure relief air passage to control the mass flow of the discharged gas, so as to achieve the effect of maintaining a stable pressure in the gas storage unit 2.

[0056] In some embodiments, the pressure control unit 5 can also be a combination of a pressure sensor and an electric control valve, such as a solenoid valve, a proportional valve, etc. The pressure sensor is used to detect the pressure of the gas storage part 2, and the electric control valve adjusts the opening degree according to the detected pressure value to control the size of the airflow passing through. For example, if the detected pressure is low, the airflow passing through will be reduced. The pressure sensor can also be arranged downstream of the gas storage part 2, but since the electric control valve adjusts the flow rate, there may be a delay when detecting pressure changes, which is not conducive to pressure control.

[0057] In some embodiments, the pressure control unit 5 can be installed on the gas replenishing part 4 or on the gas storage part 2. Generally, it is not recommended to install the pressure control unit 5 near the gas output part 3 because when an excessive amount of therapeutic gas is introduced into the gas storage part 2, the pressure control unit 5 will discharge some old gas from the gas storage part 2 to make room for the newly introduced therapeutic gas. If the position of the pressure control unit 5 is too close to the gas output part 3, the actual volume available for storing the therapeutic gas in the gas storage part 2 will be reduced. To maximize the available volume of the gas storage part 2 and reduce the size of the gas storage part 2, it is preferable to install the pressure control unit 5 on the gas replenishing part 4.

[0058] In some embodiments, the cross-sectional area S of the gas storage part 2 is 1 mm 2 to 4 cm 2 (including 4 cm 2 ). A cross-sectional area S close to or below the lower limit will cause an increase in air resistance and it is difficult to achieve the effect of rapid gas delivery. If the cross-sectional area S is close to or exceeds the upper limit, the diffusion and mixing of the therapeutic gas and the supplementary gas at the interface will be aggravated, affecting the concentration of the output therapeutic gas and reducing the utilization rate of the generated therapeutic gas.

[0059] As Figure 4 shown in the fourth embodiment, the gas replenishing part 4 can also be connected to the therapeutic gas source 1 to replenish gas for the therapeutic gas source 1.

[0060] In some embodiments, when the therapeutic gas source 1 is an electrochemical in-situ preparation device for electrochemically generating NO, the gas replenishing part 4 can input a purge gas (such as air, nitrogen, etc.) for purging the electrodes and the NO gas generated electrochemically.

[0061] Figure 6An example of an electrochemical in-situ preparation device is shown. As shown in the figure, the example electrochemical in-situ preparation device includes a reaction chamber 11, which has a gas zone and a liquid zone. The liquid zone is used to accommodate the reaction medium 12, and the gas zone is used to accommodate the product gas including NO. The electrode 13 is in contact with the reaction medium 12, and by applying a predetermined current or voltage to the electrode 13, NO gas can be generated in the reaction chamber 11. The purge gas inlet 14 is used to introduce purge gas into the reaction medium 12 to sweep away the NO gas generated in the reaction medium 12. The purge gas can be air, nitrogen, etc. In addition, the reaction medium 12 may further 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 nitrites. For example, the composition of the reaction medium 12 can refer to the content disclosed in Chinese Patent Publication No. CN114318357A published on April 12, 2022, which discloses an electrolyte for realizing high-concentration NO output, as well as a corresponding electrolytic cell and electrolysis method. The content of Chinese Patent Publication No. CN114318357A is incorporated herein by reference. An embodiment of the electrochemical in-situ preparation device for generating NO can refer to the content disclosed in Chinese Patent Publication No. CN110831640A published on February 21, 2020, which discloses a nitric oxide generation system for a gas delivery device. The content of Chinese Patent Publication No. CN110831640A is also incorporated herein by reference.

[0062] In some embodiments, when the treatment gas source 1 is an in-situ preparation device that generates NO using the arc method, the gas supplementing part 4 can input reaction gas (such as air, oxygen-containing nitrogen gas, etc.). Figure 7 An in-situ preparation device using the arc method is illustrated. As Figure 7 shown, the in-situ preparation device using the arc method may include a reaction chamber 21, which contains one or more electrodes 22. The electrodes in the reaction chamber 21 of the treatment gas source 1 generate NO through high-voltage electric shock, and the generated NO is carried out by the excess reaction gas. The in-situ preparation device may further include a reaction gas inlet 23 for introducing reaction gas into the reaction chamber 21. The reaction gas can be air. The electrodes 22 are configured to generate product gas containing the required amount of NO from the reaction gas using a high-voltage circuit.

[0063] Looking back Figure 4 , the gas supplementing part 4 can be connected to both the gas storage part 2 and the treatment gas source 1 at the same time, and input the same gas (such as air) to the gas storage part 2 and the treatment gas source 1 through a power source. Alternatively, two gas supplementing parts 4 can be provided, each gas supplementing part 4 is respectively connected to the gas storage part 2 and the treatment gas source 1, and the two gas supplementing parts 4 are respectively connected to different power sources to transport different gases, such as inputting air to the gas storage part 2 and nitrogen to the treatment gas source 1.

[0064] In addition, a flow control device 7 can be installed downstream of the treatment gas source 1 to control the flow rate of the treatment gas output by the treatment gas source 1.

[0065] The flow control unit 7 can also be installed upstream of the treatment gas source 1, as in Figure 5 the fifth embodiment shown, to control the gas flow rate entering the treatment gas source 1.

[0066] The above-mentioned treatment gas delivery device is as Figures 1 - 7 shown. It has many differences from the existing nitric oxide generation and delivery systems and methods. For example, Chinese Patent Publication No. CN110573454B describes a system and method for generating NO (for example, paragraphs

[0227] of the specification and Figures 19 - 25). The structure mentioned in CN110573454B includes a buffer tank, a piston, a diaphragm, and a diaphragm driver, forming a temporary storage, and NO gas is output through these structures. The solution disclosed in CN110573454B requires a buffer tank of a certain volume to store NO gas, which limits the miniaturization of the device. In addition, the output of nitric oxide gas depends on mechanical structures such as pistons and diaphragms, and these structures will generate friction and wear during operation. The actions of the piston and diaphragm need to be controlled through signal transmission, which poses challenges to the immediacy and reliability of the system operation.

[0067] The above limitations of CN110573454B are solved by the technical solutions described in this disclosure. For example, the power source for driving the gas storage unit 2 to output NO gas is the stable pressure within the gas storage unit 2. The medium for driving the output of NO gas is the supplementary gas filled into the gas storage unit 2 through the gas replenishing unit 4 (the interface between the supplementary gas and the NO gas within the gas storage unit 2 can be approximately regarded as a piston). During the output process of the NO gas within the gas storage unit 2, no signal transmission or other forms of control are required. The output can be achieved instantaneously depending on the pressure. In addition, using the supplementary gas as the medium during the output process can eliminate friction and wear.

[0068] In summary, the treatment gas delivery device described herein has at least the following technical advantages. First, it can follow the output of breathing gas with a sufficiently small device size. The miniaturized and lightweight design greatly reduces the limitations brought by the treatment device and facilitates integration with other treatment devices.

[0069] In addition, due to the small size of the gas storage unit 2, very little NO gas accumulates over a long time, which in turn minimizes the NO2 gas generated within the gas storage unit 2.

[0070] In addition, the therapeutic gas delivery device described herein does not require complex electromagnetic components or signal transmission for control coordination, eliminating the presence of vulnerable parts. This aspect helps to improve the high reliability and immediacy of the device.

[0071] Another significant advantage is the effective utilization of the therapeutic gas generated by the device. Compared with the "gas storage tank" technology mentioned in the background art and Chinese Patent Publication No. CN110573454B, the device described in the present disclosure has a shorter rise time when outputting therapeutic gas. In a system using a gas storage tank, in the initial stage, nitrogen oxide gas needs to be mixed with air until uniform mixing is achieved before a stable output of nitrogen oxide concentration can be obtained. In contrast, the device described herein uses a system based on the gas storage unit 2 with a smaller diameter and volume. This design allows the original gas in the gas storage unit 2 to be quickly discharged when introducing NO gas, so that the required NO concentration can be quickly adjusted within one or two breathing cycles. This makes the concentration rise period shorter and the response speed faster, highlighting the efficiency and response ability of the therapeutic gas delivery device.

[0072] Figures 1 - 7 The therapeutic gas delivery device described in can be integrated into a breathing device or system as a nitric oxide (NO) supply module. The following description illustrates an example of a breathing device ( Figures 8 - 16 ) and an example of a system ( Figure 17 ).

[0073] Respiratory device with nitric oxide (NO) supply module

[0074] As described in the background section, the respiratory follow-up therapeutic gas output requires the ability to quickly inject a certain flow rate of therapeutic gas according to the respiratory rate, flow rate, and pressure of devices such as ventilators and anesthesia machines. In some cases, the flow rate may need to reach more than 120 L / min within a short time.

[0075] To achieve respiratory follow-up transmission, a gas storage container with a certain pressure and capacity can be configured upstream of the therapeutic gas input pipeline. This gas storage container stores therapeutic gas at an appropriate time and releases the stored therapeutic gas when the inhalation flow rate rapidly increases within a short time to make up for the deficiency in the instantaneous preparation and transmission flow rate of the therapeutic gas device.

[0076] Existing NO therapeutic devices that achieve the respiratory follow-up transmission function usually have a large volume and weight. When used with a breathing device such as a ventilator, the nitric oxide therapeutic device requires its own dedicated space. This is very disadvantageous in an environment with very limited space such as an intensive care unit. When used independently, the volume and weight limitations of existing NO therapeutic devices also make it difficult to apply in occasions where portability is required, such as home use or outdoor environments.

[0077] To solve the technical problems of existing solutions,Figures 1 - 7 The described therapeutic gas delivery device serves as a nitric oxide (NO) supply module in a breathing apparatus.

[0078] Figure 8 A first embodiment of the nitric oxide supply module is shown. As shown, the NO supply module may include a housing 1000. Inside the housing 1000, there may be a reaction chamber 81, which has an inlet 810 and an outlet 811. The reaction chamber 81 may further include electrodes 812. The inlet 810 allows a reaction gas stream (usually air) to enter, and the electrodes 812 cause the reaction gas stream to pass through the reaction chamber 81 to generate a nitric oxide product gas, and the outlet 811 releases a gas stream containing the product gas.

[0079] Inside the housing 1000, there may further be a gas storage part 82 located downstream of the outlet 811. The gas storage part 82 is configured to store at least part of the product gas from the outlet 811 at a specific time. Inside the housing 1000, there may also further be a gas transfer part 83 located downstream of the outlet 811. The gas transfer part 83 is configured to conduct the gas stream containing the product gas out of the housing 1000.

[0080] The housing 1000 may further include a power source 84 connected to the gas storage part 82 to maintain the stability of the gas pressure inside the gas storage part 82.

[0081] When the flow rate output by the gas transfer part 83 outside the housing 1000 is less than the flow rate supplied by the outlet 811 to the gas transfer part 83, the excess gas is introduced into the gas storage part 82 to store at least part of the excess gas. When the flow rate required to be output by the gas transfer part 83 outside the housing 1000 exceeds the flow rate provided by the outlet 811 to the gas transfer part 83, the gas stored in the gas storage part 82 is introduced into the gas transfer part 83.

[0082] In addition, the housing 1000 can also be designed as a detachable component and combined with the breathing device 2000.

[0083] The housing 1000 can be equipped with a gas transfer interface 1001, which is connected to the gas transfer part 83. The breathing device 2000 may have an interface that is compatibly connected to the gas transfer interface 1001 and is connected to the inhalation branch 2001 of the breathing device 2000.

[0084] In Figure 8In the first embodiment of the NO supply module shown, the housing 1000 is equipped with an air inlet interface 1002. The breathing device 2000 has an interface that is compatibly connected to the air inlet interface 1002, and this interface is connected to the internal airway of the breathing device 2000. The air inlet 810 of the reaction chamber 81 is connected to the air inlet interface 1002, and reaction air flow is supplied to the reaction chamber 81 through the internal airway of the breathing device 2000. The gas storage unit 82 is also connected to the air inlet interface 1002 and receives gas through the internal airway of the breathing device 2000, where the air inlet interface 1002 serves as the power source 84.

[0085] In addition, Figure 8 the power source 84 in also includes a pressure control device 85 for maintaining the stability of the gas pressure inside the gas storage unit 82. The pressure control device 85 can be a pressure reducing valve with a pressure relief function (effectively integrating the functions of a back pressure valve and a pressure reducing valve), or a combination of a pressure reducing valve and a back pressure valve, as shown in Figure 4 of Chinese Patent Publication No. CN2023106604381. It can also be a set of mutually cooperating mass flow controllers, as shown in Figure 9 of Chinese Patent Publication No. CN2023106604381.

[0086] Figure 9 is a schematic diagram of the NO supply module in the breathing device according to the second embodiment of the present disclosure. In Figure 9 the second embodiment shown, the housing 1000 is further provided with an air inlet interface 1002. The breathing device ( Figure 9 not shown in, see Figure 8 in 2000) has an interface that is compatibly connected to the air inlet interface 1002, and this interface is connected to the internal airway of the breathing device. The air inlet 810 of the reaction chamber 81 is connected to the air inlet interface 1002, and the air inlet interface 1002 supplies reaction air flow to the reaction chamber 81 through the internal airway of the breathing device. The power source 84 includes an air pump 840 located inside the housing 1000. The air pump 840 is connected to the gas storage unit 82 for supplying gas to the gas storage unit 82. In addition, it also includes a pressure control device 85, which can use the same pressure control device as in the first embodiment (as shown in Figure 8 ).

[0087] Figure 10 is a schematic diagram of the NO supply module in the breathing device according to the third embodiment of the present disclosure. In Figure 10 the third embodiment shown, the housing 1000 is provided with an air inlet interface 1002. The breathing device ( Figure 9 not shown in, see Figure 8The 2000 in ) has an interface that matches and connects with the intake interface 1002, and this interface is connected to the internal airway of the breathing device. The intake port 810 of the reaction chamber 81 is connected to the intake interface 1002, and the intake interface 1002 supplies reaction airflow to the reaction chamber 81 through the internal airway of the breathing device.

[0088] In addition, Figure 10 the housing 1000 in ) also has a gas supply interface 1003. There is an interface on the breathing device that matches and connects with the gas supply interface 1003, and this interface is connected to the internal airway of the breathing device. The gas storage unit 82 is connected to the gas supply interface 1003, and the gas supply interface 1003 supplies gas to the gas storage unit 82 through the internal airway of the breathing device and serves as the power source 84. In addition, it may further include the pressure control device 85 in the first and second embodiments.

[0089] Figure 11 is a schematic diagram of the NO supply module in the breathing device according to the fourth embodiment of the present disclosure. In Figure 11 the fourth embodiment shown, the housing 1000 does not have an intake interface (such as Figures 8 - 10 the 1002 in ) or a gas supply interface (such as Figures 8 - 10 the 1003 in ). Inside the housing 1000, there is a first gas pump 8100, and the inlet 810 of the reaction chamber 81 is connected to the first gas pump 8100, and the first gas pump 8100 supplies reaction airflow to the reaction chamber 81. The power source 84 includes a second gas pump 840 located inside the housing 1000. The second gas pump 840 is connected to the gas storage unit 82, and this pump is used to supply gas to the gas storage unit 82. In addition, it further includes the pressure control device 85 in the foregoing embodiments.

[0090] Figure 12 is a schematic diagram of the NO supply module in the breathing device according to the fifth embodiment of the present disclosure. In Figure 12 the fifth embodiment shown, the housing 1000 does not have an intake interface (such as Figures 8 - 10 the 1002 in ) or a gas supply interface (such as Figures 8 - 10 the 1003 in ). Inside the housing 1000, there is a second gas pump 8100, and the intake port 810 of the reaction chamber 81 is connected to the second gas pump 8100, and the second gas pump 8100 supplies reaction airflow to the reaction chamber 81. The gas storage unit 82 is also connected to the second gas pump 8100, and the second gas pump 8100 supplies gas to the gas storage unit 82, thereby acting as the power source 84. In addition, it further includes the pressure control device 85 in the foregoing embodiments.

[0091] Figure 13 is a schematic diagram of the NO supply module in the breathing device according to the sixth embodiment of the present disclosure. In Figure 13In the sixth embodiment shown, the housing 1000 has no air intake interface 1002. Inside the housing 1000, there is an air pump 8100. The inlet 810 of the reaction chamber 81 is connected to the air pump 8100, and the air pump 8100 supplies reaction air flow to the reaction chamber 81. A gas supply interface 1003 is installed on the housing 1000. The interface of the breathing device ( Figure 9 not shown in the figure, see Figure 8 2000 in) matches and connects with the gas supply interface 1003, and this interface is connected to the internal air passage of the breathing device. The gas storage part 82 is connected to the gas supply interface 1003, and the gas supply interface 1003 supplies gas to the gas storage part 82 through the internal air passage of the breathing device, thereby acting as the power source 84. In addition, it also includes the pressure control device 85 in the foregoing embodiment.

[0092] In the embodiments described in the present disclosure, the gas storage part 82 may include at least one gas storage channel 820. The gas storage channel 820 may have a small enough cross-sectional area to minimize the diffusion phenomenon between gases (that is, to reduce the diffusion at the interface between the nitric oxide gas stored in the gas storage channel 820 and the air input by the power source). The cross-sectional area S of the gas storage channel 820 can be configured in the range of 1 mm 2 ≤S≤4 cm 2 range.

[0093] In addition to the various forms of the power source 84 mentioned in the foregoing embodiments, it can also be implemented in other ways. For example, the power source 84 can adopt the form of a piston cylinder, and the gas storage part 82 is integrated in the piston cylinder. By driving the piston rod, the space volume of the gas storage part 82 is changed, thereby realizing the control of the pressure of the gas storage part 82. Compared with other forms mentioned in the previous embodiments, this piston cylinder structure has some disadvantages: 1) Volume impact - the internal space of the module housing is limited, and the form of the piston cylinder may cause an increase in the overall volume of the module; 2) Reliability - the piston rod of the piston cylinder needs to perform frequent repeated driving actions, posing a challenge to its reliability; 3) Delay - the timing of driving the piston rod needs to be controlled through signal feedback, which is likely to cause delay, resulting in the internal pressure of the gas storage part 82 not matching the required pressure, affecting the output accuracy of nitric oxide; 4) Noise; 5) Power consumption.

[0094] As another example, the power source 84 can adopt the form of an airbag. In this case, the gas storage part 82 is a telescopic airbag structure, and the force to restore the deformation of the airbag structure serves as the power source. This method also has certain disadvantages. For example, the repeated deformation of the airbag will cause fatigue and wear, resulting in a limited service life.

[0095] In the embodiments of the NO supply module described in the present disclosure, the first flow control device 86 (such as Figure 8The example shown (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 rate of the reaction gas entering the reaction chamber 81. In some embodiments, the first flow control device 86 can be a mass flow controller (MFC).

[0096] In addition, a second flow control device 87 (as Figure 8 shown, but applicable to all the described embodiments) can also be installed on the gas transfer section 83 to control the flow rate of the outflowing gas stream. The second flow control device 87 can also be a mass flow controller (MFC).

[0097] Taking Figure 8 the embodiment shown (applicable to all described embodiments) as an example, a filtering device 88 can be installed on the gas transfer section 83 to filter NO2 in the product gas. The filtering device 88 is detachably connected to the gas transfer section 83. The filtering device 88 has an inlet and an outlet, which are respectively connected to the gas transfer section 83.

[0098] Taking Figure 8 the embodiment shown (applicable to all described embodiments) as an example, the filtering device 88 is located outside the housing 1000. For example, interfaces for inserting the inlet and outlet of the filtering device 88 are provided on the housing 1000, and the internal interface of the housing 1000 is connected to the gas transfer section 83. Additionally, the filtering device 88 can also be installed inside the housing 1000, close to the wall of the housing 1000, and a detachable operation window is provided at the corresponding position of the filtering device 88 on the housing 1000. The filtering device 88 is a consumable, and as the usage time extends, its filtering material (such as quicklime, etc.) may need to be replaced regularly. Placing the filtering device 88 outside the housing 1000 or close to the wall of the housing 1000 facilitates replacement. The filtering device 88 is preferably installed upstream of the second flow control device 87. Installing it upstream helps to ensure the effectiveness of breath following because the filtering device 88 has a filtering chamber filled with filtering material. If the filtering device 88 is installed downstream of the second flow control device 87, the flow rate and timeliness of the therapeutic gas output passing through the second flow control device 87 and the filtering chamber may be affected, thereby affecting the effect of breath following.

[0099] Taking Figure 8Taking the illustrated embodiment as an example (which is applicable to all the described embodiments), a detection branch 89 is installed on the gas transmission part 83. One end of the detection branch 89 is connected to the gas transmission part 83, and the other end is open to the environment. The detection branch 89 is used to measure the nitric oxide concentration in the gas transmission part 83. In addition, the detection branch 89 further includes a gas resistance 890 and a nitric oxide sensor 891, which are arranged in sequence from near the gas transmission part 83 to far from the gas transmission part 83. The setting of the gas resistance can prevent a large amount of gas from escaping into the environment through the detection branch 89, and only allows a small amount of gas to pass through the detection branch 89 to reach the sensor.

[0100] In some embodiments, Figure 8 The detection branch 89 in the illustrated example is located upstream of the second flow control device 87 and downstream of the filtering device 88. Ideally, the detection branch 89 is as close as possible to the upstream of the second flow control device 87 to ensure that the monitored NO concentration 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 will be difficult for the treatment gas to enter the detection branch 89, which is likely to result in the inability to detect the concentration of the treatment gas. Placing the detection branch 89 upstream of the filtering device 88 will cause a decrease in the actual output NO concentration.

[0101] In some embodiments, Figures 8 - 13 The illustrated NO supply module may further include a sampling and detection unit 3000, which includes a detection gas passage 3100 located inside the housing 1000 and a sampling gas passage 3200 located outside the housing 1000. The detection gas passage 3100 is connected to the sampling gas passage 3200.

[0102] Taking Figure 8 the illustrated embodiment as an example (which is applicable to all the described embodiments), one end of the sampling gas passage 3200 is connected to the inhalation branch 2001 of the breathing device 2000, and the other end is connected to the detection gas passage 3100 inside the housing 1000 through a water trap 3201. The water trap 3201 is mainly used to filter the moisture in the sampling gas to prevent damage to the downstream sensor or affect the detection result. The water trap 3201 needs to be disassembled regularly, so it is located outside the housing 1000, and the housing 1000 is provided with a mounting seat for mounting the water trap 3201.

[0103] In some embodiments, one end of the detection gas passage 3100 is connected to the water trap 3201, and the other end is open to the environment. The detection gas passage 3100 is equipped with a sampling gas pump 3101 and a sensor unit 3102. The sampling gas pump 3101 provides sampling power, and the sensor unit 3102 may include sensors such as a nitric oxide sensor, a nitrogen dioxide sensor, and an oxygen sensor, which are used to detect components such as NO, NO2, and O2 in the gas that the patient is about to inhale.

[0104] AsFigure 14 and Figure 15 As shown in Figure 15 , in the NO supply module, the sampling detection unit 3000 is optional. Figure 8 The embodiment shown in Figure 8 includes the sampling detection unit 3000. Figure 14 and Figure 15 In the embodiment shown in Figure 15 , the sampling detection unit 3000 is not included. In some embodiments, the sampling detection unit (such as 3000 shown in Figure 8 ) can be an independent module assembled with a breathing device (such as 2000 shown in Figure 8 ). Figure 8 as shown in Figure 8 ) can be an independent module assembled with a breathing device (such as 2000 shown in Figure 8 ). Figure 8 as shown in Figure 8 ).

[0105] In certain embodiments, Figures 8 - 13 a fan (see 4000 shown in Figure 8 ) can be equipped inside the housing 1000 in Figures 8 - 13 . Figure 8 For example, in the embodiment shown in Figure 8 (applicable to all described embodiments), 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 outside the housing 1000, and its main function is to promote cooling and ventilation. Figure 8 For example, in the embodiment shown in Figure 8 (applicable to all described embodiments), 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 outside the housing 1000, and its main function is to promote cooling and ventilation.

[0106] As an example, one end of the detection branch 89 connected to the environment is connected to the fan 4000, so as to be connected to the external environment of the housing 1000. Similarly, one end of the detection gas passage 3100 of the sampling detection unit 3000 connected to the environment is also connected to the fan 4000, so as to be connected to the external environment of the housing 1000. The gas dissipated into the environment through the detection branch 89 may include the product gas nitric oxide, and nitric oxide is easily oxidized into toxic nitrogen dioxide. If it accumulates inside the housing 1000, it will pose a safety hazard. Therefore, by connecting to the fan 4000, it can be discharged to the external environment as soon as possible. Similarly, a certain amount of nitric oxide and nitrogen dioxide in the detection gas passage 3100 of the sampling detection unit 3000 will also be discharged to the external environment as soon as possible through the fan 4000. In addition, the fan 4000 will disperse these gases before discharging them, preventing the accumulation of NO, NO2 and other waste gases. In certain embodiments, the fan 4000 is optional in the NO supply module (see the embodiment without a fan in Figure 14 ). Figure 14 the embodiment without a fan in Figure 14 ).

[0107] In some embodiments, when the pressure control device 85 is a pressure reducing valve with a pressure relief function, its pressure relief port can also be connected to the fan 4000 through a pipeline. The overflow port can also be directly connected to the environment. Additionally, the overflow port can also be connected to the inlet of the filtering device 88 through a pipeline.

[0108] Figure 16Schematic diagram of a portable NO supply device that can be installed on a breathing device 2000 through an installation groove 2002 according to some embodiments of the present disclosure. The housing 1000 is designed for easy carrying. The installation groove 2002 is designed to install the portable NO supply device on the breathing device 2000.

[0109] A nitric oxide (NO) preparation and transmission system

[0110] Figure 17 Schematic diagram of a nitric oxide preparation and transmission system according to some embodiments of the present disclosure is shown. As shown, the nitric oxide preparation and transmission system may include an intake unit for supplying gas to the system and a reaction chamber 171 located downstream of the intake unit. The reaction chamber may include an inlet 1710, an outlet 1711, and an electrode 1712. The inlet 1710 is connected to the intake unit to receive a reaction gas stream (such as air), and the electrode 1712 causes the reaction gas stream to pass through the reaction chamber 171 to generate a nitric oxide product gas. The outlet 1711 releases a gas stream containing the product gas.

[0111] As Figure 17 shown, the NO preparation and transmission system may further include a transmission unit for guiding the gas stream containing the product gas out of the system. The transmission unit includes a gas storage part 172, a gas transmission part 173, a gas supplement part 174, and a pressure control unit 175. As Figure 17 shown, the gas storage part 172 is located downstream of the outlet 1711 and is used to store at least a part of the product gas from the outlet 1711 at a specific time. The gas transmission part 173 is also located downstream of the outlet 1711 and is used to guide the gas stream containing the product gas out of the system. One end of the gas supplement part 174 is connected to the intake unit, and the other end is connected to the gas storage part 172 for supplementing gas to the gas storage part 172. The pressure control unit 175 is connected to the gas storage part 172 for maintaining the pressure in the gas storage part 172 at a preset value. One end of the gas supplement part 174 may also be connected to an independent intake unit to achieve the function of supplementing gas.

[0112] In some embodiments, the intake unit may include one or more components. For example, the intake unit may include an intake filter for filtering particles, volatile organic compounds, etc. in the air to prevent damage to the internal components of the device (such as an air pump) or being inhaled by the patient. Downstream of the intake filter, the intake unit may further include an air pump (which can be a diaphragm pump or other types of booster pumps). The pump draws air from the environment into the device, provides an air source for generating NO in the reaction chamber 171, and also provides a pressurized air source for the system.

[0113] Downstream of the air pump, the intake unit may further include a gas container, the purpose of which is to reduce the fluctuation of the pulsating gas stream generated by the air pump, and stabilize the air flow rate and the pressure generated by the intake unit.

[0114] Although the air pump provides a pressurized gas source, it may also generate water. If water enters the system, it may affect the generation of NO treatment gas in the arc reaction chamber 171 and may affect the system filter's absorption of NO2. To solve this problem, an air dehumidification device can be added. The dehumidification device can be installed upstream of the air pump, but water may be generated again after passing through the air pump. The dehumidification device can be set downstream of the gas container, but liquid water may have already formed downstream, and the liquid water needs to be treated, which is costly. Therefore, the dehumidification device is preferably located between the air pump and the gas container to quickly reduce the humidity of the compressed gas source. This dehumidification method can be a Nafion tube or other methods of filtering water or water vapor.

[0115] In some embodiments, the intake unit may further include a backpressure valve to prevent the pipeline from bursting when the pressure in the intake unit is too high, and a pressure sensor can also be added to detect the pressure in the intake unit. If the pressure is too high, the air extraction can be stopped or reduced.

[0116] In some embodiments, when the flow rate output by the gas transmission unit 173 to the outside of the system is less than the flow rate provided by the outlet 1711 to the gas transmission unit 173, the excess gas enters the gas storage unit 172, and at least a part of the excess gas is stored therein. Conversely, when the flow rate that needs to be output by the gas transmission unit 173 to the outside of the system exceeds the flow rate provided by the outlet 1711 to the gas transmission unit 173, the gas stored in the gas storage unit 172 is directed to the gas transmission unit 173.

[0117] In addition, the pressure control unit 175 can be a pressure reducing valve with a pressure relief function (effectively integrating the backpressure valve function and the pressure reducing valve function into one unit), or a combination of a pressure reducing valve and a backpressure valve (as shown in Chinese Patent CN2023106604381 Figure 4 ), or a set of mass flow controllers that cooperate with each other (as shown in Chinese Patent CN2023106604381 Figure 9 ).

[0118] In some embodiments, the gas storage unit 172 includes at least one gas storage channel 1720. The gas storage channel 1720 has a cross-sectional area small enough 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 channel 1720 meets the air input from the power source). The cross-sectional area of the gas storage channel 1720 is less than 20 square centimeters, preferably less than 4 square centimeters, and more desirably less than 1 square centimeter. In addition, in order to make full use of the gas storage space of the gas storage unit 172 and minimize the overall space it occupies, the port for inputting / outputting nitric oxide gas in the gas storage unit 172 is located at one end of the gas storage channel 1720, while the port for connecting to the power source 174 is located at the other end of the gas storage channel 1720.

[0119] In some embodiments, the intake unit is connected to the inlet 1710 of the reaction chamber 171 through a pipeline equipped with a first flow control device 176, and the first flow control device 176 is used to adjust the flow rate of the reaction gas entering the reaction chamber 171. The first flow control device 176 can also be arranged downstream of the outlet 1711 of the reaction chamber 171. The first flow control device 176 can be a mass flow controller (MFC).

[0120] In some embodiments, the NO preparation and transmission system may further include a second flow control device 177, which is located on the gas transmission part 3 and is used to adjust the flow rate of the outflowing gas stream. The second flow control device 177 can also be a mass flow controller (MFC).

[0121] In certain embodiments, the NO preparation and transmission system may further include a filtering device 178, which is arranged on the gas transmission part 173 and is used to filter nitrogen dioxide in the product gas. The filtering device 178 can be detachably connected to the gas transmission part 173. The filtering device 178 can include an inlet and an outlet, and each inlet and outlet is connected to the gas transmission part 173. In addition, the delivery system may further include a detection branch 179 located on the gas transmission part 173. One end of the detection branch 179 is connected to the gas transmission part 173, and the other end is open to the environment, and can measure the nitric oxide concentration in the gas transmission part 173. The detection branch 179 can include a gas resistance 1790 and a nitric oxide sensor 1791, which are arranged in sequence from near to far from the gas transmission part 173. The gas resistance is designed to prevent a large amount of gas from escaping to the environment through the detection branch 179, and only allows a small amount of gas to pass through the detection branch 179 to reach the sensor.

[0122] In certain embodiments, Figure 17The NO preparation and transmission system in [[ ]] may further include a sampling and detection unit 3000, which may include a detection gas passage 3100 and a sampling gas passage 3200. The detection gas passage 3100 is connected to the sampling gas passage 3200. One end of the sampling gas passage 3200 is connected to the inhalation branch 2001 of the breathing device 2000, and the other end is connected to the detection gas passage 3100 through a water trap 3201. The function of the water trap 3201 is to filter the moisture in the sampled gas to prevent damage to downstream sensors or affect the detection results.

[0123] In some embodiments, one end of the detection gas passage 3100 is connected to the water trap 3201, and the other end leads to the environment. The detection gas passage 3100 is equipped with a sampling air pump 3101 and a sensor device 3102. The sampling air pump 3101 provides power for sampling, and the sensor unit 3102 may include sensors such as a nitric oxide sensor, a nitrogen dioxide sensor, and an oxygen sensor, for detecting NO, NO2, O2, etc. in the gas that the patient is about to inhale.

[0124] In some embodiments, Figure 17 The filtering device 178 in [[ ]] can accommodate multiple independent filtering chambers to achieve different filtering functions. For example, one filtering chamber is filled with calcium oxide filter agent and is connected to the gas transmission part 173 to remove nitrogen dioxide in the gas. Another filtering chamber is filled with potassium permanganate filter agent for removing waste gas, and its outlet is connected to the environment.

[0125] When the pressure control unit 175 is a pressure reducing valve with an overflow function, its overflow port can also be connected to the filtering device 178 chamber for removing waste gas through a pipeline. This setting can prevent untreated gas from being directly released into the environment when the product gas is discharged from the overflow port through the filtering device 178.

[0126] In some embodiments, a cut-off valve is installed upstream of the filtering device 178 on the gas transmission part 173. When the service life of the filtering device 178 expires, there is no need to shut down the system for replacement. The filtering device 178 can be directly disassembled and replaced. When the filtering device 178 is disassembled, the cut-off valve will immediately close to maintain the stability of the internal pressure of the device. When a new filtering device 178 is reinserted, the cut-off valve is opened by the filtering device 178 to reconnect the gas transmission part 173 and the filtering device 178, so that the NO treatment gas can be normally output. The cut-off valve can also be a solenoid valve.

[0127] In some embodiments, Figure 17The NO preparation and transmission system therein may further include a pressure relief device. The pressure relief device may include a pressure relief pipeline. One end of the pipeline may be connected between the gas storage part 172 and the pressure control unit 175, or between the gas storage part 172 and the stop valve, or between the filtering device 178 and the flow control device 176. For example, an electromagnetic valve may be installed on the pressure relief pipeline. When the device stops outputting NO, opening the electromagnetic valve can quickly discharge NO from the system, preventing NO from staying in the system for too long and oxidizing into NO2. This also helps to balance the internal and external pressures of the system and extend the service life of the device. Another method is to open the electromagnetic valve and stop the arc simultaneously after stopping the NO output, and use the air in the intake unit to discharge the NO gas in the system. When the NO output stops, the gas passage in the system contains air. The other end of the pressure relief pipeline may be connected to the chamber of the filtering device 178 for removing waste gas.

[0128] In summary, compared with the existing solutions, Figure 17 the NO preparation and transmission system therein has at least the following technical advantages:

[0129] 1) An internal integrated gas source, not relying on an external gas source, enables the device to have multiple usage scenarios and is convenient for use in cases of device connection, handling, or transfer;

[0130] 2) The internal integrated gas source can handle the humidity of the input air and reduce the influence of humidity on the nitrogen oxide generation efficiency in the arc reaction chamber;

[0131] 3) The internal integrated gas source can handle the humidity of the input air and reduce the generation of more impurity gases after water vapor enters the arc reaction chamber;

[0132] 4) The internal integrated gas source can handle the humidity of the input air and reduce the possibility of water vapor condensing in the system, preventing the corrosion of the system by the acidic liquid formed after NO2 dissolves in water;

[0133] 5) The internal integrated gas source can handle the humidity of the input air and reduce the influence of water vapor on the filtering effect of the filtering material for impurity gases after entering the filter;

[0134] 6) Release the internal pressure of the system after the device stops, balance the internal and external pressures, and extend the service life of the device;

[0135] 7) Purge the device after stopping the treatment to ensure that the gas passage inside the device is filled with air, preventing NO from remaining in the system and oxidizing into NO2, which may affect the subsequent treatment of patients;

[0136] 8) Using the stop valve can replace the filter without stopping the device, reducing pressure, or leaking the NO treatment gas, thereby reducing the treatment interruption time caused by filter replacement.

[0137] In practical applications, the therapeutic gas delivery device described in this article can be used to deliver NO therapeutic gas to a ventilator. The gases are mixed before being inhaled by the patient. For example, a patient with a tidal volume of 500 milliliters needs to inhale NO at a concentration of 10 ppm. When the mixing ratio of the NO gas inhaled by the patient to the ventilator air is 1:9, the therapeutic gas delivery device needs to release 50 milliliters of NO gas at a concentration of 100 ppm. Approximately 35 milliliters of the gas storage part in the therapeutic gas delivery device can achieve this goal while maintaining an internal pressure of 0.5 bar. Alternatively, when the pressure of the gas storage part is maintained at 1 bar, a gas storage volume of approximately 25 milliliters can also achieve this goal. The pressure in the inspiratory branch of the ventilator is relatively low and can be ignored. This situation highlights the compact and lightweight characteristics of the device, greatly improving its compatibility with ventilators and other medical devices.

[0138] If the mixing ratio in the above example is too high, this may undesirably dilute the oxygen in the ventilator. On the other hand, a lower mixing ratio will result in the release of less NO gas, allowing for a smaller gas storage volume, but a higher concentration of NO gas must be obtained from the device. This requires more complex production methods, especially in the case of using arc technology, which will increase the production of nitrogen dioxide. Therefore, there is an optimal range for the mixing of NO gas and air in the therapeutic gas delivery device.

[0139] Another key point is the relationship between the pressure and volume of the gas storage part: the higher the pressure, the smaller the required volume, but the higher the requirements for the system's tightness and reliability.

[0140] In addition, the patient's tidal volume will directly affect the size required for the gas storage part. Some people may have a tidal volume exceeding 1000 milliliters, or even 1500 milliliters. In a preferred embodiment, the volume of the gas storage part is designed to be smaller than the patient's tidal volume. Adjusting the mixing ratio, the pressure of the gas storage part, and the NO concentration helps to minimize the volume required for the gas storage part.

[0141] Empirical tests show that in the most effective models, the volume of the gas storage part should be less than 1500 milliliters; ideally less than 1200 milliliters; more ideally less than 1000 milliliters; even more ideally less than 800 milliliters. In some cases, a volume within 200 milliliters is sufficient. The cross-sectional area of the gas storage part is preferably between 1 square millimeter and 4 square centimeters (inclusive); preferably within 2 square centimeters (inclusive).

[0142] The above description is for illustrative purposes only. They are not exhaustive and are not limited to the precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent by considering the specification and practice of the disclosed embodiments. For example, the described embodiments include hardware, but the systems and methods consistent with the present disclosure can be implemented by hardware and software. In addition, although certain components are described as being connected to each other, these components can be integrated with each other or distributed in any suitable manner.

[0143] In addition, although illustrative embodiments have been described herein, their scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., aspects across various embodiments), adaptations or alterations based on the present disclosure. Further, the steps of the disclosed methods can be modified in any manner, including reordering the steps or inserting or deleting steps.

[0144] The features and advantages of the present disclosure are apparent from the detailed description. In addition, since many modifications and variations can readily occur to those studying the present disclosure, it is not desired to limit the present disclosure to the exact structures and operations illustrated and described, and accordingly, all suitable modifications and equivalents are within the scope of the present disclosure.

[0145] It will be understood that the above embodiments can be implemented by hardware, software (program code), or a combination of hardware and software. If implemented by software, it can be stored in the above computer-readable medium. When the software is executed by a processor, at least some of the steps of the disclosed methods can be performed.

[0146] In the foregoing specification, embodiments of the present invention have been described with reference to numerous specific details, which may vary depending on the embodiment. Certain adjustments and modifications can be made to the described embodiments. For those skilled in the art, other embodiments will be apparent in view of the specification and practice disclosed herein. This specification and examples are for reference only, and the true scope and spirit of the present disclosure are indicated by the following claims. In addition, the order of steps shown in the figures is for illustrative purposes only and does not mean that any given method of operation must perform all steps, nor is it limited to any particular order of steps. Thus, those skilled in the art will understand that these steps can be performed in a different order when implementing the same method. In addition, the devices shown in the figures are illustrative only, and a given device or system can include different combinations of components or modules of these devices.

Claims

1. A therapeutic gas delivery device, comprising: A therapeutic gas source (1) for generating therapeutic gas; A gas storage unit (2) connected downstream of the therapeutic gas source (1), the gas storage unit (2) being configured to store at least a portion of the therapeutic gas from the therapeutic gas source (1); A gas output unit, connected downstream of the gas storage unit (2), the gas output unit being configured to be connected to the inhalation branch of a breathing device and to output therapeutic gas to the inhalation branch of the breathing device as needed; A gas replenishment unit (4) connected to the gas storage unit (2), the gas replenishment unit (4) being configured to replenish gas to the gas storage unit (2); A flow control unit (6) connected to the gas output unit (3) for controlling the amount of therapeutic gas delivered through the gas output unit (3); and A pressure control unit (5) connected to the gas storage unit (2) for stabilizing the pressure within the gas storage unit (2) and maintaining the pressure inside the gas storage unit (2) higher than the pressure in the inhalation branch of the breathing device.

2. The therapeutic gas delivery device according to claim 1, wherein The pressure control unit (5) is configured to stabilize the pressure within the gas storage unit (2) at a preset value greater than 120 cm of water column.

3. The therapeutic gas delivery device according to claim 1, wherein When the patient downstream of the gas output unit (3) is in the exhalation phase, or when the flow rate of the therapeutic gas output by the gas output unit (3) to the patient is less than the 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 in the gas storage unit (2).

4. The therapeutic gas delivery device according to claim 3, wherein When the flow rate of the therapeutic gas output by the gas output unit (3) to the patient exceeds the flow rate provided by the therapeutic gas source (1), the therapeutic gas stored in the gas storage unit (2) is spontaneously output to the gas output unit (3).

5. The therapeutic gas delivery device according to claim 1, wherein The gas replenished by the gas replenishment unit (4) includes air, nitrogen, or therapeutic gas.

6. The therapeutic gas delivery device according to claim 1, wherein The inlet of the gas replenishment unit (4) is connected to a power source to ensure the driving force for replenishing gas to the gas storage unit (2), wherein the power source includes a high-pressure gas cylinder, a central gas source in a hospital, or a gas pump.

7. The therapeutic gas delivery device according to claim 1, wherein When the gas replenishment unit (4) is connected to a power source, the pressure control unit (5) includes a back-pressure valve (5a), wherein the back-pressure valve (5a) is configured to When the pressure within the gas storage unit (2) exceeds the preset value, release the gas within the gas storage unit (2) through the pressure relief port of the back-pressure valve (5a) to stabilize the pressure within the gas storage unit (2).

8. The therapeutic gas delivery device according to claim 7, wherein When the power source connected to the gas replenishment unit (4) includes a high-pressure gas cylinder or a gas pump, the pressure control unit (5) includes a combination of a pressure reducing valve (5b) and a back-pressure valve (5a), wherein: The pressure reducing valve (5b) is used to stabilize the input pressure from the power source.

9. The therapeutic gas delivery device according to claim 1, wherein The pressure control unit (5) includes a valve component that simultaneously has a pressure reducing function and a back pressure function.

10. The therapeutic gas delivery device according to claim 1, wherein the pressure control unit (5) includes a first mass flow controller, which is further coupled to the gas supplementing part (4) to control the flow rate of the gas supplemented by the gas supplementing part (4) to the gas storage part (2).

11. The therapeutic gas delivery device according to claim 10, wherein an overflow gas path is configured between the first mass flow controller and the gas storage part (2), and the overflow gas path includes a second mass flow controller, which is used to control the flow rate of the gas released from the gas storage part (2).

12. The therapeutic gas delivery device according to claim 1, wherein the pressure control unit (5) includes a combination of a pressure sensor and an electric control valve, wherein the pressure sensor is configured to detect the pressure in the gas storage part (2), and the electric control valve is configured to control an opening according to the detected pressure to adjust the air flow through the opening.

13. The therapeutic gas delivery device according to claim 12, wherein the electric control valve includes a solenoid valve or a proportional valve.

14. The therapeutic gas delivery device according to claim 1, wherein The cross-sectional area of ​​the gas storage part (2) is 1 mm 2 Up to 4cm 2 between.

15. The therapeutic gas delivery device according to claim 1, wherein the gas supplementing part (4) is further connected to the therapeutic gas source (1) and is configured to supplement gas to the therapeutic gas source (1).

16. The therapeutic gas delivery device according to claim 1, wherein the therapeutic gas source (1) includes an electrochemical instant preparation device for electrochemically generating nitric oxide (NO), and the gas supplementing part (4) is further configured to input a purging gas to the therapeutic gas source (1) for purging the electrodes and the electrochemically generated nitric oxide, wherein the purifying gas includes air or nitrogen.

17. The therapeutic gas delivery device according to claim 1, wherein the therapeutic gas source (1) includes an instant preparation device for generating NO by the arc method, and the gas supplementing part (4) is configured to input a reaction gas to the therapeutic gas source (1), wherein the electrodes inside the reaction chamber of the therapeutic gas source (1) are used to generate NO by high-voltage electric shock, and the generated NO is carried out by the excess part of the reaction gas.

18. The therapeutic gas delivery device according to claim 17, wherein the reaction gas includes air or a gas containing oxygen and nitrogen.

19. The therapeutic gas delivery device according to claim 1, wherein the gas supplementing part (4) is configured to be simultaneously connected to the gas storage part (2) and the therapeutic gas source (1), and input gas to the gas storage part (2) and the therapeutic gas source (1) through a power source.

20. The therapeutic gas delivery device according to claim 1, wherein the gas supplementing part (4) includes a first supply part connected to the gas storage part (2) and a second supply part connected to the therapeutic gas source (1), wherein the first supply part and the second supply part are connected to different power sources to respectively transport different gases to the gas storage part (2) and the therapeutic gas source (1).

21. The therapeutic gas delivery device according to claim 20, wherein the first supply part is configured to input air into the gas storage part (2); and the second supply part is configured to input nitrogen into the therapeutic gas source (1).

22. The therapeutic gas delivery device according to claim 1, further comprising a second flow control unit (7) installed downstream of the therapeutic gas source (1) for controlling the flow rate of the therapeutic gas output from the therapeutic gas source (1).

23. The therapeutic gas delivery device according to claim 1, further comprising a second flow control unit (7) installed upstream of the therapeutic gas source (1) for controlling the gas flow rate entering the therapeutic gas source (1).

24. The therapeutic gas delivery device according to claim 1, wherein the therapeutic gas comprises one or more of NO, CO, H2S or H2.

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