Apparatuses, systems, and methods for transmitting therapeutic gas

Abstract

The present disclosure describes a therapeutic gas delivery device. The therapeutic gas delivery device may include a therapeutic gas source configured to generate a therapeutic gas, and a gas storage portion connected downstream of the therapeutic gas source. The gas storage portion is configured to store at least a portion of a therapeutic gas from the therapeutic gas source. Further, the device may include a gas output portion connected downstream of the gas storage portion, the gas output portion configured to output the therapeutic gas on demand. Further, the apparatus may include a replenishment portion connected to the gas storage portion, the replenishment portion configured to replenish gas to the gas storage portion. Further, the apparatus may include a pressure control unit connected to the gas storage portion, the pressure control unit configured to stabilize a pressure within the gas storage portion. Further, the device may include a flow control unit connected to the gas output portion, the flow control unit configured to control an amount of therapeutic gas delivered through the gas output portion.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480037135.7 (22) Application Date 2024.06.05 (66) Domestic Priority Data 202310660438.1 2023.06.06 CN 202410444278.1 2024.04.12 CN (85) PCT International Application Entering National Phase Date 2025.12.03 (86) PCT International Application Application Data PCT / CN2024 / 097474 2024.06.05 (87) PCT International Application Publication Data WO2024 / 251144 EN 2024.12.12 (71) Applicant Nanjing Nuoling Biotechnology Co., Ltd. Address 211800 No. 73 Tanmi Road, Jiangbei New District, Nanjing City, Jiangsu Province, Tree House Building 16, C1-2 (72) Inventors: Zhang Yuyan, Zhang Wangkun, Kong Xianghai, Li Yuan, Wang Fei (74) Patent Agency: Guangzhou Wenguan Ni Law Intellectual Property Agency (General Partnership) 44348 Patent Attorneys: He Jinbiao, Zhang Yuying (51) Int.Cl. A61M 16 / 00 (2006.01) (54) Invention Title: Apparatus, System and Method for Delivering Therapeutic Gas (57) Abstract: This disclosure 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 section connected downstream of the therapeutic gas source. The gas storage section is configured to store at least a portion of the therapeutic gas from the therapeutic gas source. In addition, the device may include a gas output section connected downstream of the gas storage section, the gas output section being configured to output the therapeutic gas on demand. Furthermore, the device may include a replenishment section connected to the gas storage section, the replenishment section being configured to replenish gas to the gas storage section. Additionally, the device may include a pressure control unit connected to the gas storage section, the pressure control unit being configured to stabilize the pressure within the gas storage section. Furthermore, the device may include a flow control unit connected to the gas output section, the flow control unit being configured to control the amount of therapeutic gas delivered through the gas output section.Claims (3 pages), Description (16 pages), Drawings (13 pages), CN 121358517 A, 2026.01.16, CN 1 21 35 85 17 A 1. A therapeutic gas delivery system, comprising: a therapeutic gas source configured to generate therapeutic gas; a gas storage section connected downstream of the therapeutic gas source, the gas storage section being configured to store at least a portion of the therapeutic gas from the therapeutic gas source; a gas output section connected downstream of the gas storage section, the gas output section being configured to output the therapeutic gas on demand; a replenishment section connected to the gas storage section, the replenishment section being configured to replenish gas to the gas storage section; and a flow control unit coupled to the gas output section, the flow control unit being configured to control the amount of therapeutic gas delivered through the gas output section. 2. The therapeutic gas delivery system of claim 1, further comprising: a pressure control unit connected to the gas storage section, the pressure control unit being configured to stabilize the pressure within the gas storage section. 3. The therapeutic gas delivery system of claim 2, wherein the pressure control unit is configured to stabilize the pressure within the gas storage section at a preset value greater than 120 cmH2O. 4. The therapeutic gas delivery system of claim 2, wherein the gas output section is configured to deliver the therapeutic gas to a breathing device, and the pressure control unit is configured to maintain the pressure within the gas storage section higher than the pressure in the inspiratory branch of the breathing device. 5. The therapeutic gas delivery system of claim 2, wherein: when the supply section is connected to a power source, the pressure control unit includes a back pressure valve, wherein the back pressure valve is configured to: release gas from the gas storage section through a pressure relief port of the back pressure valve to stabilize the pressure within the gas storage section when the pressure within the gas storage section exceeds a preset value. 6. The therapeutic gas delivery system of claim 5, wherein: when the power source connected to the supply section includes a high-pressure gas cylinder or a gas pump, the pressure control unit includes a combination of a pressure reducing valve and a back pressure valve, wherein: the pressure reducing valve is configured to stabilize the input pressure from the power source. 7. The therapeutic gas delivery system of claim 2, wherein: the pressure control unit includes a valve assembly providing both pressure reduction and back pressure functions. 8. The therapeutic gas delivery system of claim 2, wherein: the pressure control unit includes a first mass flow controller, the first mass flow controller being further coupled to the supply section to control the flow rate of gas supplied from the supply section to the gas storage section.9. The therapeutic gas delivery system of claim 8, wherein: a pressure relief passage is provided between the first MFC and the gas storage section, wherein the pressure relief passage includes a second MFC configured to control the flow rate of gas released from the gas storage section, thereby stabilizing the pressure within the gas storage section. 10. The therapeutic gas delivery system of claim 2, wherein: the pressure control unit includes a combination of a pressure sensor and an electrically controlled valve, wherein: the pressure sensor is configured to detect the pressure in the gas storage section, and the electrically controlled valve is configured to control an opening based on the detected pressure to regulate the airflow through the opening. 11. The therapeutic gas delivery system of claim 10, wherein: the electrically controlled valve includes a solenoid valve or a proportional valve. 12. The therapeutic gas delivery system of claim 1, wherein: when a patient downstream of the gas output section is in the exhalation phase or the flow rate of the therapeutic gas output from the gas output section to the patient is less than the flow rate of the therapeutic gas supplied by the therapeutic gas source, at least a portion of the therapeutic gas supplied by the therapeutic gas source is stored in the gas storage section. 13. The therapeutic gas delivery system of claim 12, wherein: when the flow rate of the therapeutic gas output from the gas output section to the patient exceeds the flow rate supplied by the therapeutic gas source, the therapeutic gas stored in the gas storage section is spontaneously output to the gas output section. 14. The therapeutic gas delivery system of claim 1, wherein: the gas supplied by the replenishment section includes air, nitrogen, or the therapeutic gas. 15. The therapeutic gas delivery system of claim 1, wherein: the inlet of the replenishment section is connected to a power source to ensure the driving force for replenishing gas to the gas storage section, wherein the power source includes a high-pressure gas cylinder, a hospital central gas source, or a gas pump. 16. The therapeutic gas delivery system of claim 1, wherein: the cross-sectional area of ​​the gas storage portion is between 1 mm² and 4 cm², including the extreme values. 17. The therapeutic gas delivery system of claim 1, wherein: the supply portion is further connected to the therapeutic gas source and configured to supply gas to the therapeutic gas source. 18. The therapeutic gas delivery system of claim 1, wherein: the therapeutic gas source includes an electrochemical instantaneous preparation device for electrochemically generating nitric oxide, and the supply portion is further configured to input a purge gas into the therapeutic gas source for purging electrodes and carrying out electrochemically generated NO, wherein the purge gas includes air or nitrogen.19. The therapeutic gas delivery system of claim 1, wherein: the therapeutic gas source includes an on-the-spot preparation device for generating NO using an electric arc method, and the supply section is configured to input a reactive gas into the therapeutic gas source, wherein electrodes in 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 away by an excess portion of the reactive gas. 20. The therapeutic gas delivery system of claim 19, wherein: the reactive gas includes air or an oxygen-nitrogen gas. 21. The therapeutic gas delivery system of claim 1, wherein: the supply section is configured to connect to both the gas storage section and the therapeutic gas source, and inputs gas into both the gas storage section and the therapeutic gas source via a power source. 22. The therapeutic gas delivery system of claim 1, wherein: the supply section includes a first supply section connected to the gas storage section and a second supply section connected to the therapeutic gas source, wherein the first supply section and the second supply section are connected to different power sources to deliver different gases to the gas storage section and the therapeutic gas source, respectively. 23. The therapeutic gas delivery system of claim 22, wherein: the first supply section is configured to input air into the gas storage section; and the second supply section is configured to input nitrogen into the therapeutic gas source. Claims 2 / 3, page 3, CN 121358517 A 24. The therapeutic gas delivery system of claim 1, further comprising: a second flow control unit installed downstream of the therapeutic gas source to control the flow rate of the therapeutic gas output from the therapeutic gas source. 25. The therapeutic gas delivery system of claim 1, further comprising: a second flow control unit installed upstream of the therapeutic gas source to control the flow rate of the gas entering the therapeutic gas source. 26. The therapeutic gas delivery system of claim 1, wherein the therapeutic gas comprises one or more of NO, CO, H2S, or H2. Claims 3 / 3 Page 4 CN 121358517 A Apparatus, System and Method for Delivering Therapeutic Gas

[0001] Cross-Reference to Related Applications

[0002] This application claims priority to Chinese Provisional Patent Application No. 2023106604381, filed June 6, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to the field of medical device technology, and in particular to a therapeutic gas delivery system for delivering therapeutic gases on demand. Background Art

[0004] Inhalation therapy involves supplying therapeutic gases to a patient via a device such as a ventilator to achieve a therapeutic effect.Taking nitric oxide (NO) gas as an example, it has been found in recent years that nitric oxide plays a role in transmitting important signals and regulating cell function in the human body. It can help promote blood circulation in the body. Nitric oxide can rapidly diffuse across biological membranes without any mediating mechanism, transmitting information produced by one cell to surrounding cells. Nitric oxide has a variety of biological functions and readily participates in electron transport reactions and redox processes in the body. Direct inhalation therapy of nitric oxide has been approved by the United States Food and Drug Administration for the treatment of persistent pulmonary hypertension in newborns and has been shown to improve the body's oxygenation capacity and reduce the need for high-risk extracorporeal life support in critically ill patients. Controlled and appropriate administration of nitric oxide can specifically reduce pulmonary hypertension and improve oxygenation. Currently, nitric oxide inhalation therapy is widely used in neonatal respiratory medicine and is also applicable in intensive care, cardiothoracic surgery, respiratory medicine, anesthesiology and other clinical medical fields.

[0005] Therapeutic gases (such as nitric oxide) are usually used in conjunction with respiratory equipment (such as ventilators and anesthesia machines). The gas is delivered to the inhalation tubing of these devices and then inhaled by the patient for gas inhalation therapy. Breath-following therapeutic gas delivery is the preferred method for delivering therapeutic gases because it involves delivering therapeutic gases according to the patient's respiratory flow (i.e., the delivery of therapeutic gases is synchronized with the patient's breathing pattern). Compared to conventional therapeutic gas delivery, the breath-following method maintains a stable concentration of inhaled therapeutic gas throughout the breathing process, significantly reducing the impact of changes in breathing pattern and parameters on the concentration of inhaled therapeutic gas.

[0006] Since respiratory flow fluctuates significantly throughout the patient's breathing process, achieving breath-following often requires the rapid delivery of a specific volume of therapeutic gas within a short period of time. For devices that generate therapeutic gases on demand, ensuring that the instantaneously generated therapeutic gas matches the instantaneous delivery consumption is a challenge, posing a significant challenge to achieving breath-following delivery functionality in instantaneous therapeutic gas generation devices.

[0007] The therapeutic gas delivery devices and systems 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 needs of different populations (including adults, children, and newborns) with different tidal volumes and respiratory rates for the accuracy and stability of therapeutic gas concentrations, especially in high-frequency oscillatory ventilation.

[0008] Some existing instantaneous generation devices are designed to achieve respiratory follow-up delivery. As disclosed in PCT Patent Publication No. WO2022127902A, a "pressure vessel" is provided downstream of the therapeutic gas generation device and upstream of the therapeutic gas delivery pipeline.This pressure vessel is a large-capacity gas storage tank capable of withstanding a certain pressure. It stores excess therapeutic gas generated (see page 1 / 16 of the manual, CN 121358517 A), and relies on the pressure generated by the therapeutic gas accumulated inside the tank. Thus, when a large amount of therapeutic gas needs to be rapidly output in a short time, this pressure can be used to output the therapeutic gas stored in the tank, compensating for the consumption that cannot be generated in time during on-the-spot preparation.

[0009] This container-based approach has drawbacks. For example, when a large flow rate of therapeutic gas needs to be output from the tank, pressure fluctuations will occur inside the storage tank, which may affect the flow rate of the output therapeutic gas, ultimately leading to deviations in the concentration of the delivered therapeutic gas. The larger the capacity of the storage tank, the better the effect of avoiding pressure fluctuations during large flow rate output. Under some conventional flow rate requirements, the storage tank needs to be very large to ensure that the above-mentioned defects do not occur. This greatly limits the miniaturization of the equipment and limits the applicable scenarios of the on-the-spot therapeutic gas generation device. Another drawback is that when the capacity of the storage tank is very large, the therapeutic gas may accumulate inside for a long time. Taking NO as an example, NO can be oxidized into toxic NO2, and the NO prepared on the spot will stay in a large-capacity storage tank for too long, which will lead to an increase in NO2 content, thereby affecting the quality of the output therapeutic gas. Summary of the Invention

[0010] According to some embodiments of the present disclosure, an apparatus for generating and / or delivering therapeutic gases (e.g., nitric oxide (NO)) is provided.

[0011] In one general aspect, 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 a portion of the therapeutic gas from the therapeutic gas source (1). The therapeutic gas delivery apparatus may also include a gas output section connected downstream of the gas storage section (2), the gas output section being configured to output therapeutic gas as needed. The therapeutic gas delivery apparatus may also include a replenishment section (4) connected to the gas storage section (2), the replenishment section (4) being configured to replenish gas to the gas storage section (2). The system may also include a pressure control unit (5) connected to the gas storage section (2), the pressure control unit (5) being configured to stabilize the pressure within the gas storage section (2). The therapeutic gas delivery device may also include a flow control unit (6) connected to the gas output section (3), the flow control unit (6) being configured to control the amount of therapeutic gas delivered through the gas output section (3).

[0012] The implementation of the therapeutic gas delivery device may include one or more of the following features. The pressure control unit (5) is configured to stabilize the pressure within the gas storage section (2) at a preset value greater than 120 cm water column.The gas output section is configured to deliver therapeutic gas to the breathing device, and the pressure control unit (5) is configured to maintain the pressure in the gas storage section (2) higher than the pressure in the inspiratory branch of the breathing device. When the patient downstream of the gas output section (3) is in the expiratory phase or the flow rate of the therapeutic gas output from the gas output section (3) to the patient is less than the flow rate of the therapeutic gas supplied by the therapeutic gas source (1), at least a portion of the therapeutic gas supplied by the therapeutic gas source (1) is stored in the gas storage section (2).

[0013] When the flow rate of the therapeutic gas output from the gas output section (3) to the patient exceeds the flow rate supplied by the therapeutic gas source (1), the therapeutic gas stored in the gas storage section (2) is spontaneously output to the gas output section (3).

[0014] The gas supplied by the supply section (4) may include air or therapeutic gas. The inlet of the supply section (4) is connected to a power source to ensure the driving force for supplying gas to the gas storage section (2), wherein the power source may include a high-pressure gas cylinder, a hospital central gas source, or a gas pump.

[0015] When the supply section (4) is connected to a power source, the pressure control unit (5) may include a back pressure valve (5a), wherein the back pressure valve (5a) is configured to release gas in the gas storage section (2) through the pressure relief port of the back pressure valve (5a) when the pressure in the gas storage section (2) exceeds a preset value, so as to stabilize the pressure in the gas storage section (2).

[0016] When the power source connected to the supply section (4) may include a high-pressure gas cylinder or a gas pump, the pressure control unit (5) may include a combination of a pressure reducing valve (5b) and a back pressure valve (5a), wherein the pressure reducing valve (5b) is configured to stabilize the input pressure from the power source.

[0017] The pressure control unit (5) may include a valve assembly that provides both pressure reducing function and back pressure function. The pressure control unit (5) may include a first mass flow controller (MFC) further coupled to the supply section (4) to control the flow rate of gas supplied from the supply section (4) to the gas storage section (2). A pressure relief passage is configured between the first MFC and the gas storage section (2), the pressure relief passage may include a second MFC configured to control the flow rate of gas released from the gas storage section (2), thereby stabilizing the pressure within the gas storage section (2).

[0018] The pressure control unit (5) may include a combination of a pressure sensor and an electrically controlled valve, wherein: the pressure sensor is configured to detect the pressure in the gas storage section (2), and the electrically controlled valve is configured to control an opening based on the detected pressure to regulate the airflow through the opening. The electrically controlled valve may include a solenoid valve or a proportional valve.

[0019] The cross-sectional area of ​​the gas storage section is between 1 mm² and 4 cm², including the endpoints.The supply section (4) is also connected to the therapeutic gas source (1) and configured to supply gas to the therapeutic gas source (1). The therapeutic gas source (1) may include an electrochemical instantaneous preparation device for electrochemically generating nitric oxide (NO), and the supply section (4) is also configured to input a purge gas into the therapeutic gas source (1) for purging the electrodes and carrying out the electrochemically generated NO, wherein the purge gas may include air or nitrogen.

[0020] The therapeutic gas source (1) may include an instantaneous preparation device for generating NO using an electric arc method, and the supply section (4) is configured to input a reaction gas into the therapeutic gas source (1), wherein the electrodes in 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 an excess portion of the reaction gas.

[0021] The reaction gas may include air or an oxygen-nitrogen gas. The supply section (4) is configured to connect to both the gas storage section (2) and the therapeutic gas source (1), and to input gas into both the gas storage section (2) and the therapeutic gas source (1) via a power source. The supply section (4) may include a first supply section connected to the gas storage section (2) and a second supply section connected to the therapeutic gas source (1), wherein the first supply section and the second supply section are connected to different power sources to deliver different gases to the gas storage section (2) and the therapeutic gas source (1), respectively.

[0022] The first supply section is configured to input air into the gas storage section (2); and the second supply section is configured to input nitrogen into the therapeutic gas source (1).

[0023] The therapeutic gas delivery system may further include: a second flow control unit (7) 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 therapeutic gas delivery system may further include: a second flow control unit (7) installed upstream of the therapeutic gas source (1) to control the flow rate of the gas entering the therapeutic gas source (7).

[0024] It should be understood that the foregoing general description and the following detailed description are merely illustrative and explanatory and do not limit the claimed embodiments.

[0025] The accompanying drawings form part of this specification. The accompanying drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of some of the disclosed embodiments as given in the appended claims. Brief Description of the Drawings

[0026] FIG1 is a schematic diagram of a therapeutic gas delivery device according to a first embodiment of the present disclosure.

[0027] FIG2 is a schematic diagram of a therapeutic gas delivery device according to a second embodiment of the present disclosure.

[0028] FIG3 is a schematic diagram of a therapeutic gas delivery device according to a third embodiment of the present disclosure.

[0029] FIG4 is a schematic diagram of a therapeutic gas delivery device according to a fourth embodiment of the present disclosure.

[0030] FIG5 is a schematic diagram of a therapeutic gas delivery device according to a fifth embodiment of the present disclosure.

[0031] FIG6 is a schematic diagram of an electrochemical instantaneous preparation apparatus according to some embodiments of the present disclosure. Specification 3 / 16 pages 7 CN 121358517 A

[0032] FIG7 is a schematic diagram of an arc method instantaneous preparation apparatus according to some embodiments of the present disclosure.

[0033] FIG8 is a schematic diagram of a nitric oxide (NO) supply module in a breathing apparatus according to a first embodiment of the present disclosure.

[0034] FIG9 is a schematic diagram of an NO supply module in a breathing apparatus according to a second embodiment of the present disclosure.

[0035] FIG10 is a schematic diagram of an NO supply module in a breathing apparatus according to a second embodiment of the present disclosure.

[0036] FIG11 is a schematic diagram of an NO supply module in a breathing apparatus according to a third embodiment of the present disclosure.

[0037] FIG12 is a schematic diagram of an NO supply module in a breathing apparatus according to a fourth embodiment of the present disclosure.

[0038] FIG13 is a schematic diagram of an NO supply module in a breathing apparatus according to a fifth embodiment of the present disclosure.

[0039] FIG14 is a schematic diagram of an NO supply module in a breathing apparatus according to a sixth embodiment of the present disclosure.

[0040] FIG15 is a schematic diagram of an NO supply module in a breathing apparatus according to a seventh embodiment of the present disclosure.

[0041] FIG16 is a schematic diagram of an NO supply module installed in a breathing apparatus via a mounting slot according to some embodiments of the present disclosure.

[0042] FIG17 is a schematic diagram of an NO preparation and delivery system according to some embodiments of the present disclosure.

[0043] FIG18 is a schematic diagram of a gas storage section in an embodiment of the present disclosure.

[0044] FIG19 is another schematic diagram of a gas storage section in an embodiment of the present disclosure.

[0045] FIG20 is yet another schematic diagram of a gas storage section in an embodiment of the present disclosure. Detailed Description

[0046] Reference will now be made in detail to the disclosed embodiments. Unless otherwise defined, technical or scientific terms have the meanings commonly understood by those skilled in the art. The disclosed embodiments have been described in sufficient detail to enable those skilled in the art to practice the disclosed embodiments. It should be understood that other embodiments may be utilized and changes may be made without departing from the scope of the disclosed embodiments. Therefore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0047] FIG1 is a schematic diagram of a therapeutic gas delivery device according to a first embodiment of the present disclosure. As shown, the therapeutic gas delivery device 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).

[0048] The therapeutic gas source (1) is used to generate therapeutic gases on an instantaneous basis, such as NO, CO, H2S, H2, etc.

[0049] A gas storage section (2) is connected downstream of the therapeutic gas source (1) and is configured to store therapeutic gas supplied by the therapeutic gas source (1).

[0050] A gas output section (3) is connected downstream of the therapeutic gas source (1) to allow the therapeutic gas to be delivered to the patient.

[0051] A replenishment section (4) is connected to the gas storage section (2) to replenish gas into the gas storage section (2).

[0052] A pressure control unit (5) is connected to the gas storage section (2) and is configured to stabilize the pressure in the gas storage section (2) at a preset value. In some embodiments, the preset value is generally greater than 120 cmH2O. By stabilizing the pressure in the gas storage section (2) at the preset value, ensuring that the pressure in the gas storage section (2) is higher than the pressure in the inspiratory branch of the ventilator, the therapeutic gas in the gas storage section (2) is allowed to spontaneously output into the ventilator tubing. The higher the preset pressure value, the greater the maximum flow rate that the therapeutic gas delivery device can achieve, thereby improving the respiratory follow-up effect. However, the increase in pressure also increases the reliability requirements of the equipment.

[0053] The flow control unit (6) is located on or upstream of the gas output section (3) and is configured to control the amount or flow rate of therapeutic gas delivered to the patient. Specification 4 / 16 pages 8 CN 121358517 A

[0054] When the patient downstream of the gas output section (3) is in the exhalation phase or the amount of gas delivered to the patient end by the gas output section (3) is less than the amount provided by the therapeutic gas source (1), excess therapeutic gas enters the gas storage section (2), and the gas storage section (2) stores all or part of the excess therapeutic gas.

[0055] When the amount of gas delivered to the patient end by the gas output section (3) exceeds the amount provided by the therapeutic gas source (1), the therapeutic gas stored in the gas storage section (2) is spontaneously transferred to the gas output section (3). The gas replenished by the supply section (4) to the gas storage section (2) can be air or therapeutic gas, etc. The inlet of the supply section (4) can be connected to a power source to provide sufficient driving force to replenish the gas into the gas storage section (2). For example, the power source can be a high-pressure gas cylinder, a hospital central gas source, a gas pump, etc.

[0056] There are various ways to implement the pressure control unit (5). As shown in the first embodiment of FIG1, when the supply section (4) is connected to a stable and controllable power source, the pressure control unit (5) can be a back pressure valve. When new therapeutic gas is introduced into the gas storage section (2), causing the gas pressure in the gas storage section (2) to exceed a preset value, the gas will be discharged from the gas storage section (2) through the pressure relief port of the back pressure valve to maintain a stable pressure in the gas storage section (2).

[0057] As shown in the second embodiment of FIG2, when the power source connected to the supply section (4) is a high-pressure gas cylinder or a gas pump, the pressure control unit (5) may include a pressure reducing valve (5b) and a back pressure valve (5a). The pressure reducing valve (5b) reduces and stabilizes the pressure input by the power source. When the gas pressure in the gas storage section (2) exceeds a preset value, the gas is discharged from the gas storage section (2) through the pressure relief port of the back pressure valve (5a) to maintain a stable pressure in the gas storage section (2).

[0058] As shown in the third embodiment of FIG3, some valve devices / assemblies may have both pressure reducing and back pressure functions. Therefore, such a valve assembly (5c) may be installed on the gas storage section (4) to achieve the same effect as the pressure reducing valve (5b) and back pressure valve (5a) in the second embodiment.

[0059] In addition to the above-described mechanical valve form, the pressure control unit may also take the form of a mass flow controller (MFC). For example, a first mass flow controller may be provided on the supply section (4) to control the mass flow rate of the gas supplied to the gas storage section (2). A pressure relief gas path can be configured between the first mass flow controller and the gas storage section (2), and a second mass flow controller can be set on the pressure relief gas path to control the mass flow rate of the discharged gas, thereby achieving the effect of maintaining a stable pressure in the gas storage section (2).

[0060] In some embodiments, the pressure control unit (5) can also be a combination of a pressure sensor and an electrically controlled valve (such as a solenoid valve, a proportional valve, etc.). The pressure sensor is used to detect the pressure in the gas storage section (2), and the electrically controlled valve adjusts its opening based on the detected pressure value to control the amount of airflow through the opening. For example, if a low pressure is detected, the airflow 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 the flow regulation performed by the electrically controlled valve may be detrimental to pressure control.

[0061] In some embodiments, the pressure control unit (5) can be installed on the supply 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 expel some of the older gas from the gas storage section (2) to make room for the newly introduced therapeutic gas. If the pressure control unit (5) is placed 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. In order to maximize the usable volume of the gas storage section (2) and minimize the size of the gas storage section (2), it is preferable to mount the pressure control unit (5) on the supply section (4).

[0062] In some embodiments, the cross-sectional area S of the gas storage section (2) ranges from 1 mm² to 4 cm², including the extreme values.A cross-sectional area S close to or below the lower limit will result in increased air resistance, making it difficult to achieve rapid gas delivery. A cross-sectional area S close to or above the upper limit will exacerbate the diffusion of the therapeutic gas and its mixing with the supplementary gas at its interface, affecting the concentration of the output therapeutic gas and reducing the utilization rate of the generated therapeutic gas.

[0063] As shown in the fourth embodiment of FIG4, the supply section (4) may also be connected to the therapeutic gas source (1) to supply gas to the therapeutic gas source (1).

[0064] In some embodiments, when the therapeutic gas source (1) is an electrochemical instant preparation device for electrochemically generating NO, the supply section (4) may input a purge gas (air, nitrogen, etc.) to purge the electrodes and carry out the electrochemically generated NO gas.

[0065] FIG6 shows an exemplary electrochemical instant preparation device. As shown, the exemplary electrochemical instant preparation device includes a reaction chamber (11) having a gas region and a liquid region. The liquid region is configured to contain the reaction medium (12), and the gas region is configured to contain the product gas, including NO. An electrode (13) is in contact with the reaction medium (12), and NO gas can be generated within the reaction chamber (11) by applying a predetermined current or voltage to the electrode (13). A purge gas inlet (14) is used to introduce purge gas into the reaction medium (12) to purge the NO gas generated in the reaction medium (12), wherein the purge gas is air, nitrogen, etc. Furthermore, the reaction medium (12) may contain a buffer solution, a nitrite ion source, and a catalyst, wherein the catalyst comprises a metal ligand complex, and the nitrite ion source comprises one or more types of nitrites. For example, the composition of the reaction medium (12) can be referenced to the contents disclosed in Chinese Patent Publication No. CN114318357A published on April 12, 2022, which discloses an electrolyte for achieving high-concentration NO output, as well as a corresponding electrolytic cell and electrolysis method. The contents of Chinese Patent Publication No. CN114318357A are incorporated herein by reference. Exemplary embodiments of an electrochemical instantaneous preparation apparatus for generating NO can be found in Chinese Patent Publication No. CN110831640A, published on February 21, 2020, which discloses a nitric oxide generation system for a gas delivery device. The contents of Chinese Patent Publication No. CN110831640A are also incorporated herein by reference.

[0066] In some embodiments, when the therapeutic gas source (1) is an instantaneous preparation apparatus for generating NO using an electric arc method, the supply section (4) can input a reactive gas (air, oxygen-containing nitrogen gas, etc.). Figure 7 shows an exemplary instantaneous preparation apparatus using an electric arc method.As shown in Figure 7, the instantaneous preparation device using the electric arc method may include a reaction chamber (21) containing one or more electrodes (22). The electrodes in the reaction chamber (21) of the therapeutic gas source (1) generate NO by high-voltage electric shock, and the generated NO is carried out by excess reactive gas. The instantaneous preparation device may also include a reactive gas inlet (23) for introducing reactive gas into the reaction chamber (21). The reactive gas may be air. The electrodes (22) are configured to generate a product gas from the reactive gas using a high-voltage circuit, the product gas containing a desired amount of NO.

[0067] Referring again to Figure 4, the supply section (4) may be connected to both the gas storage section (2) and the therapeutic gas source (1), and the same gas (such as air) is supplied to both the gas storage section (2) and the therapeutic gas source (1) by a power source. Alternatively, two supply sections (4) may be provided, each connected to a gas storage section (2) and a therapeutic gas source (1), respectively. The two supply sections (4) are each connected to different power sources to deliver different gases, such as air to the gas storage section (2) and nitrogen to the therapeutic gas source (1).

[0068] In addition, a flow control unit (7) may 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.

[0069] The flow control unit (7) may also be installed upstream of the therapeutic gas source (1), as shown in the fifth embodiment of FIG5, to control the flow rate of the gas entering the therapeutic gas source 1.

[0070] The therapeutic gas delivery device described above and shown in FIG1-7 differs from existing NO generation and delivery systems and methods in several aspects. For example, Chinese Patent Publication No. CN110573454B describes a system and method for generating NO (e.g., paragraph

[0227] and FIG19-25 of the specification). The structure mentioned in CN110573454B includes a buffer tank, a piston, a diaphragm, and a diaphragm actuator, forming a temporary storage tank, through which NO gas is output. The specification disclosed in CN110573454B (page 6 / 16, CN 121358517 A) requires a buffer tank of a certain volume to store NO gas, which limits the miniaturization of the device. Furthermore, the output of NO gas depends on mechanical structures such as pistons and diaphragms, which experience friction and wear during operation. The movement of the piston and diaphragm needs to be controlled via signal transmission, posing challenges to the immediacy and reliability of the system operation.

[0071] The technical solution described in this disclosure solves the above-mentioned limitations of CN110573454B. For example, the power source for driving the output of NO gas from the gas storage section (2) is a stable pressure within the gas storage section (2).The medium used to drive the NO gas output is the replenishment gas supplied to the gas storage section (2) through the replenishment section (4) (the interface between the replenishment gas and the NO gas in the gas storage section (2) can be approximated as a piston). During the output of NO gas in the gas storage section (2), no signal transmission or other form of control is required. The output can be achieved instantaneously through pressure dependence. Furthermore, the use of replenishment gas as a medium during the output process eliminates friction and wear.

[0072] In summary, the therapeutic gas delivery device described herein has at least the following technical advantages. First, it can achieve respiratory-following gas output with a sufficiently small device size. The miniaturized and lightweight design greatly reduces the limitations imposed by the treatment setup and facilitates integration with other therapeutic devices.

[0073] Furthermore, due to the small size of the gas storage section, the long-term accumulation of NO gas is minimized, which in turn minimizes the generation of NO2 gas in the gas storage section.

[0074] In addition, the therapeutic gas delivery device described herein does not require complex electromagnetic components or signal transmission for control coordination, thereby eliminating the presence of wear parts. This contributes to the high reliability and immediacy of the device.

[0075] Another significant advantage is the efficient utilization of the therapeutic gas produced by the device. Compared to the prior art and the "gas storage tank" technology mentioned in Chinese Patent Publication No. CN110573454B, the device described in this disclosure exhibits a shorter rise time when delivering the therapeutic gas. In systems with gas storage tanks, the initial stage involves mixing NO gas with air until a homogeneous mixture is achieved, after which the output NO concentration can be stabilized. In contrast, the device described herein uses a system based on a gas storage section with a smaller diameter and volume. This design allows for the rapid expulsion of the original gas within the gas storage section when NO gas is introduced, thereby rapidly adjusting to the desired NO concentration within one to two breathing cycles. This results in a shorter concentration rise phase and a faster response, highlighting the efficiency and responsiveness of the therapeutic gas delivery device.

[0076] The therapeutic gas delivery device described in Figures 1-7 can be incorporated as a nitric oxide (NO) supply module into a breathing apparatus or system. The following description illustrates an example breathing apparatus (Figures 8-16) and an example breathing system (Figure 17).

[0077] Breathing Device with Nitric Oxide (NO) Supply Module

[0078] As described in the Background section, breathing-following therapeutic gas output requires the ability to rapidly inject a certain flow rate of therapeutic gas according to the breathing frequency, flow rate, and pressure of devices such as ventilators and anesthesia machines. In some cases, the flow rate may need to reach 120 L / min or more for a short period of time.

[0079] To achieve breathing-following delivery, a gas storage container with a certain pressure and capacity can be configured upstream of the therapeutic gas input pipeline.The gas storage container stores therapeutic gas at appropriate times and releases the stored therapeutic gas when the inhalation flow rate increases rapidly in a short period of time to compensate for any short-term deficiencies in the instantaneous preparation and delivery flow rate of the therapeutic gas unit.

[0080] Existing NO therapy devices that implement respiratory follow-up delivery functions are generally large in size and weight. When used in conjunction with a respiratory device (such as a ventilator), the NO therapy device requires its own dedicated space. This is disadvantageous in environments with very limited space, such as ICUs. When used alone, the size and weight limitations of existing NO therapy devices also make them difficult to apply to scenarios requiring portability, such as home use or outdoor environments.

[0081] To address the technical challenges of existing solutions, the therapeutic gas delivery device described in Figures 1-7 can be used as a nitric oxide (NO) supply module in a respiratory device. Specification 7 / 16 pages 11 CN 121358517 A

[0082] A first embodiment of the NO supply module is shown in Figure 8. As shown, the NO supply module may include a housing (1000). The housing (1000) may include a reaction chamber (81) having an inlet (810) and an outlet (811). The reaction chamber (81) may also include an electrode (812). An inlet (810) allows a reaction gas stream (typically air) to enter, the electrode (812) enables the reaction gas stream passing through the reaction chamber (81) to generate a nitric oxide product gas, and an outlet (811) releases the gas stream containing the product gas.

[0083] The housing (1000) may also include a gas storage section (82) located downstream of the outlet (811). The gas storage section (82) is configured to store at least a portion of the product gas from the outlet (811) at a specific time. The housing (1000) may also include a gas delivery section (83) located downstream of the outlet (811). The gas delivery section (83) is configured to output the gas stream containing the product gas to the outside of the housing (1000).

[0084] The housing (1000) may also 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).

[0085] When the flow rate output from the gas delivery section (83) to the outside of the housing (1000) is less than the flow rate supplied from the outlet (811) to the gas delivery section (83), excess gas is introduced into the gas storage section (82) to store at least a portion of the excess gas. When the required flow rate output from the gas delivery section (83) to the outside of the housing (1000) exceeds the flow rate supplied from the outlet (811) to the gas delivery section (83), the gas stored inside the gas storage section (82) is directed to the gas delivery section (83).

[0086] Furthermore, the housing (1000) may be designed as a detachable assembly incorporated into the breathing device (2000).

[0087] The housing (1000) may be equipped with a gas delivery interface (1001) connected to the gas delivery section (83). The breathing device (2000) may have an interface compatible with the gas delivery interface (1001) and connected to the inhalation branch (2001) of the breathing device (2000).

[0088] In the first embodiment of the NO supply module shown in FIG8, the housing (1000) is equipped with an air inlet (1002). The breathing device (2000) has an interface compatible with the air inlet (1002) and is connected to the internal airway of the breathing device (2000). The inlet (810) of the reaction chamber (81) is connected to the air inlet (1002), and a reaction gas flow is supplied to the reaction chamber (81) through the internal airway of the breathing device (2000). The gas storage section (82) is also connected to the air inlet (1002) to receive gas through the internal airway of the breathing device (2000), wherein the air inlet (1002) serves as a power source (84).

[0089] Furthermore, the power source (84) in FIG8 includes a pressure control device (85) for maintaining a stable internal air pressure within the gas storage section (82). The pressure control device (85) may be a pressure reducing valve with a pressure relief function (effectively integrating the functions of a back pressure valve and a pressure reducing valve into one unit), or it may be a combination of a pressure reducing valve and a back pressure valve, as shown in FIG4 of Chinese Patent Publication No. CN2023106604381, or it may be a set of mutually cooperating mass flow controllers, as shown in FIG9 of Chinese Patent Publication No. CN2023106604381.

[0090] FIG9 is a schematic diagram of the NO supply module in the breathing device according to a second embodiment of the present disclosure. In the second embodiment shown in FIG9, the housing (1000) is also equipped with an air inlet (1002). The breathing apparatus (not shown in FIG. 9, see 2000 in FIG. 8) has an interface compatible with the air inlet (1002), which is connected to the internal airway of the breathing apparatus. The inlet (810) of the reaction chamber (81) is connected to the air inlet (1002), which supplies a reaction gas flow to the reaction chamber (81) through the internal airway of the breathing apparatus. The power source (84) includes an air pump (840) located within the housing (1000). The air pump (840) is connected to the gas storage section (82) and is used to supply gas to the gas storage section (82). In addition, the power source also includes a pressure control device (85), which may employ the same pressure control device as in the first embodiment (as shown in FIG. 8).

[0091] FIG. 10 is a schematic diagram of the NO supply module in a breathing apparatus according to a third embodiment of the present disclosure. In the third embodiment shown in FIG. 10, the housing (1000) is equipped with an air inlet (1002).The breathing apparatus (not shown in FIG. 9, see 2000 in FIG. 8) has an interface that mates with and connects to the air inlet (1002), and this interface is connected to the internal airway of the breathing apparatus, page 8 / 16 of the instruction manual 12 CN 121358517 A. The inlet (810) of the reaction chamber (81) is connected to the air inlet (1002), and the air inlet (1002) supplies the reaction gas flow to the reaction chamber (81) through the internal airway of the breathing apparatus.

[0092] In addition, the housing (1000) in FIG. 10 also has an air supply interface (1003). The breathing apparatus is equipped with an interface that mates with and connects to the air supply interface (1003), and this interface is connected to the internal airway of the breathing apparatus. The gas storage section (82) is connected to the air supply interface (1003), and the air supply interface (1003) supplies gas to the gas storage section (82) through the internal airway of the breathing apparatus and serves as a power source (84). Furthermore, the power source (84) may also include a pressure control device (85) from the first and second embodiments.

[0093] FIG11 is a schematic diagram of an NO supply module in a breathing apparatus according to a fourth embodiment of the present disclosure. In the fourth embodiment shown in FIG11, the housing (1000) does not have an air inlet (1002 in FIG8-10) or an air supply inlet (1003 in FIG8-10). A first air pump (8100) is provided inside the housing (1000), and the air inlet (810) of the reaction chamber (81) is connected to the first air pump (8100), which supplies a reaction gas flow to the reaction chamber (81). The power source (84) includes a second air pump (840) located inside the housing (1000). The second air pump (840) is connected to a 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 aforementioned embodiments.

[0094] FIG12 is a schematic diagram of the NO supply module in a breathing apparatus according to a fifth embodiment of the present disclosure. In the fifth embodiment shown in FIG12, the housing (1000) does not have an air inlet (1002 in FIG8-10) or an air supply inlet (1003 in FIG8-10). A second air pump (8100) is provided inside the housing (1000), and the air inlet (810) of the reaction chamber (81) is connected to the second air pump (8100), which supplies a reaction gas flow to the reaction chamber (81). A gas storage section (82) is also connected to the second air pump (8100), which supplies gas to the gas storage section (82) and thus serves as a power source (84). Furthermore, the power source (84) includes a pressure control device (85) from the aforementioned embodiments.

[0095] FIG13 is a schematic diagram of the NO supply module in a breathing apparatus according to a sixth embodiment of the present disclosure.In the sixth embodiment shown in FIG13, the housing (1000) does not have an air inlet (1002). An air pump (8100) is provided inside the housing (1000), and the air inlet (810) of the reaction chamber (81) is connected to the air pump (8100), which supplies a reaction gas flow to the reaction chamber (81). The housing (1000) is equipped with an air supply interface (1003). The breathing device (not shown in FIG9, see 2000 in FIG8) has an interface that matches and connects to the air supply interface (1003), and this interface is connected to the internal airway of the breathing device. A gas storage section (82) is connected to the air supply interface (1003), which supplies gas to the gas storage section (82) through the internal airway of the breathing device, thereby serving as a power source (84). Furthermore, the power source (84) includes a pressure control device (85) from the aforementioned embodiments.

[0096] In the embodiments described in this disclosure, the gas storage section (82) may include at least one gas storage channel (820). The gas storage channel (820) may have a sufficiently small cross-sectional area to minimize diffusion between gases (i.e., reduce diffusion at the interface between the nitric oxide gas stored in the gas storage channel (820) and the air input through the power source). The cross-sectional area S of the gas storage channel may be configured in the range of 1 mm² ≤ S ≤ 4 cm².

[0097] In addition to the various forms of power source (84) mentioned in the foregoing embodiments, other methods may be used. For example, the power source (84) may be in the form of a piston cylinder, and the gas storage section (82) may be integrated into the piston cylinder. The pressure inside the gas storage section (82) is controlled by driving the piston rod to change the volume of the space inside the gas storage section (82). Compared to 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 lead to an increase in the overall volume of the module; 2) Reliability - the piston rod of the piston cylinder needs to frequently repeat the driving action, which poses a challenge to its reliability; 3) Delay - the driving time of the piston rod needs to be controlled by signal feedback, which may lead to delay, causing the internal pressure of the gas storage part (82) to mismatch with the expected pressure and affecting the accuracy of nitric oxide output; 4) Noise; 5) Power consumption.

[0098] As another example, the power source (84) may be in the form of an airbag. In this case, the gas storage part (82) may adopt an airbag structure that can expand and contract as the power source (84). In particular, the force that restores the deformation of the airbag structure is used as the power source. This method also has certain disadvantages, such as the repeated deformation of the airbag leading to fatigue and wear, resulting in a limited service life.

[0099] In an embodiment of the NO supply module shown in this disclosure, a first flow control device (86) (as shown in FIG. 8, but applicable to all described embodiments) is installed on an upstream pipe 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) may be a mass flow controller (MFC).

[0100] Furthermore, a second flow control device (87) (as shown in FIG. 8, but applicable to all described embodiments) may be installed on the gas delivery section (83) to control the flow rate of the outflow gas. The second flow control device (87) may also be a mass flow controller (MFC).

[0101] Taking the embodiment shown in FIG. 8 as an example (applicable to all described embodiments), a filter device (88) may be installed on the gas delivery section (83) to filter NO2 from the product gas. The filter device (88) is detachably connected to the gas delivery section (83). The filter device (88) has an inlet and an outlet, each of which is connected to the gas delivery section (83).

[0102] Taking the embodiment shown in FIG8 as an example (applicable to all described embodiments), the filter device (88) is located outside the housing (1000). The housing (1000) is provided with interfaces for the inlet and outlet of the filter device (88) to be inserted, and the interface inside the housing (1000) is connected to the gas delivery section (83). Alternatively, the filter device (88) may be installed inside the housing (1000), close to the wall of the housing (1000), and a removable operating window is provided at the corresponding position of the filter device (88) on the housing (1000). The filter device (88) is a consumable, and its filter material (such as calcium hydroxide) may need to be replaced periodically as the usage time increases. Setting the filter device (88) outside the housing (1000) or close to the wall of the housing (1000) facilitates replacement. Preferably, the filter device (88) is installed upstream of the second flow control device (87). Since the filter device (88) has a filter chamber filled with filter material, setting it upstream is beneficial to ensure the effectiveness of breathing follow. If the filter device (88) is located downstream of the second flow control device (87), 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 affecting the effectiveness of respiratory tracking.

[0103] Taking the embodiment shown in FIG8 as an example (applicable to all embodiments described), a detection branch (89) is installed on the gas delivery section (83), one end of which is connected to the gas delivery section (83) and the other end is open to the environment. The detection branch (89) is used to measure the concentration of nitric oxide in the gas delivery section (83).Furthermore, the detection branch (89) includes an air resistance (890) and a nitric oxide sensor (891) arranged sequentially from near the gas delivery section (83) to far away from the gas delivery section (83). The air resistance can be set to prevent a large amount of gas from escaping into the environment through the detection branch (89), while allowing only a small amount of gas to pass through to the sensor.

[0104] In some embodiments, the detection branch (89) in the example shown in FIG8 is located upstream of the second flow control device (87) and downstream of the filter device (88). Ideally, the detection branch (89) is set as close as possible 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 set downstream of the second flow control device (87), the therapeutic gas will have difficulty entering the detection branch (89), which may result in the inability to detect the concentration of the therapeutic gas. Setting the detection branch (89) upstream of the filter device (88) will result in a lower actual output concentration of NO.

[0105] In some embodiments, the NO supply module shown in Figures 8-13 may further include a sampling and detection unit (3000), which includes a detection gas path (3100) located inside the housing (1000) and a sampling gas path (3200) located outside the housing (1000). The detection gas path (3100) is connected to the sampling gas path (3200).

[0106] Taking the embodiment shown in Figure 8 as an example (applicable to all described embodiments), one end of the sampling gas path (3200) is connected to the inhalation branch (2001) of the breathing device (2000), and the other end is connected to the detection gas path (3100) inside the housing (1000) through a water trap (3201). The water trap (3201) is mainly used to filter moisture in the sampling gas to prevent damage to downstream sensors or affect the detection results. Since the water trap (3201) needs to be disassembled periodically, it is located outside the housing (1000), and the housing (1000) is equipped with a mounting base for mounting the water trap (3201).

[0107] In some embodiments, one end of the detection gas path (3100) is connected to the water trap (3201), and the other end is open to the environment. The detection gas path (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, an oxygen sensor, etc., to detect components such as NO, NO2, O2, etc. in the gas that the patient is about to inhale.

[0108] The sampling detection unit (3000) in the NO supply module is optional, as shown in the embodiments shown in FIG14 and 15, and does not include a sampling detection unit (3000 as shown in FIG8).In some embodiments, the sampling detection unit (3000 as shown in FIG8) may be a separate module assembled with the breathing device (2000 as shown in FIG8).

[0109] In some embodiments, the housing (1000) in FIG8-13 may be equipped with a fan (see 4000 in FIG8 as an example). Taking the embodiment shown in FIG8 as an example (applicable to all described embodiments), the fan (4000) is located on the inner wall of the housing (1000), and ventilation holes are provided on the housing (1000) at the location of the fan (4000). The fan (4000) may also be provided on the outside of the housing (1000), its main function being to facilitate cooling and ventilation.

[0110] For example, one end of the detection branch (89) connected to the environment is connected to the fan (4000), thereby connecting to the external environment of the housing (1000). Similarly, the end of the detection gas path (3100) of the sampling and detection unit (3000) connected to the environment is also connected to the fan (4000), thereby connecting to the external environment of the housing (1000). Gases escaping into the environment through the detection branch (89) may include the product gas nitric oxide, which is easily oxidized to toxic nitrogen dioxide. If it accumulates inside the housing (1000), it may pose a safety hazard; therefore, connecting it to the fan (4000) allows it to be discharged into the external environment as quickly as possible. Similarly, a certain amount of nitric oxide and nitrogen dioxide in the detection gas path (3100) of the sampling and detection unit (3000) are also discharged into the external environment as quickly as possible through the fan (4000). Furthermore, the fan (4000) disperses these gases before discharge to prevent the accumulation of waste gases such as NO and NO2. In some embodiments, the fan (4000) is optional within the NO supply module (see the embodiment without the fan in Figure 14).

[0111] 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) via a pipe. The pressure relief port can also be directly connected to the environment. Alternatively, the pressure relief port can be connected to the inlet of the filter device (88) via a pipe.

[0112] FIG16 is a schematic diagram of a portable NO supply device that can be mounted on a breathing apparatus (2000) via a mounting slot (2002) according to some embodiments of the present disclosure. The breathing apparatus shown in FIG16 is a portable NO supply device, wherein the housing (1000) is designed to be easy to carry. The mounting slot (2002) is designed to mount the portable NO supply device onto the breathing apparatus (2000).

[0113] Nitric Oxide (NO) Preparation and Delivery System

[0114] FIG17 shows a schematic diagram of an NO preparation and delivery system according to some embodiments of the present disclosure. As shown, the NO preparation and delivery 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 an electrode (1712). The inlet (1710) is connected to an intake unit to receive a reaction gas stream (e.g., air), and the electrode (1712) enables the reaction gas stream to pass through the reaction chamber (171) to generate a nitric oxide product gas. The outlet (1711) releases the gas stream containing the product gas. Specification 11 / 16 pages 15 CN 121358517 A

[0115] The NO preparation and delivery system shown in FIG17 may further include a delivery unit for outputting the gas stream containing the product gas from the system. The delivery unit includes a gas storage section (172), a gas delivery section (173), a replenishment gas section (174), and a pressure control unit (175). As shown in FIG17, the gas storage section (172) located downstream of the outlet (1711) is used to store at least a portion of the product gas from the outlet (1711) at a specific time. The gas delivery section (173), also located downstream of the outlet (1711), is used to output the gas flow containing the product gas to the system. A replenishment gas section (174) is connected at one end to the intake unit and at the other end to the gas storage section (172) for replenishing gas to the gas storage section (172). A pressure control unit (175) is connected to the gas storage section (172) and is used to maintain the pressure within the gas storage section (172) at a preset value. One end of the replenishment gas section (174) may also be connected to a separate intake unit to perform the replenishment gas function.

[0116] In some embodiments, the intake unit may include one or more components. For example, the intake unit may include an intake filter that filters particulate matter, VOCs, etc., from the air to prevent damage to internal components of the device (e.g., the air pump) or to prevent them from being inhaled by the patient. Downstream of the intake filter, the intake unit may also include an air pump (which may be a diaphragm pump or other type of booster pump). The pump draws air from the environment into the device, providing an air source in the reaction chamber (171) to generate NO, and also provides a pressurized air source for the system.

[0117] Downstream of the pump, the intake unit may also include an air gas container, the purpose of which is to reduce fluctuations in the pulsating airflow generated by the pump and stabilize the airflow and the pressure generated by the intake unit.

[0118] Although the pump provides a pressurized air source, it also generates water. If water enters the system, it may affect the generation of NO therapeutic gas in the arc reaction chamber (171) and may affect the absorption of NO2 by the system's filters. To address this issue, an air dehumidification unit can be added. This dehumidification unit can be located upstream of the pump, but water may be generated again after passing through the pump. The dehumidification unit can be located 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 pump and the air gas container to quickly reduce the humidity of the compressed air source.The dehumidification method may be a Nafion pipe or other method of filtering water or water vapor.

[0119] In some embodiments, the intake unit may also include a back pressure valve to prevent the pipe from bursting when the pressure of the intake unit is too high, and a pressure sensor may be added to detect the pressure of the intake unit. If the pressure is too high, the pumping may be stopped or reduced.

[0120] In some embodiments, when the flow rate output from the gas delivery section (173) to the outside of the system is less than the flow rate supplied to the gas delivery section (173) from the outlet (1711), excess gas enters the gas storage section (172), where at least a portion of the excess gas is stored. Conversely, when the flow rate required to be output from the gas delivery section (173) to the outside of the system exceeds the flow rate supplied to the gas delivery section (173) from the outlet (1711), the gas stored inside the gas storage section (172) is directed to the gas delivery section (173).

[0121] Furthermore, the pressure control unit (175) may be a pressure reducing valve with a pressure relief function (effectively integrating the back pressure valve function and the pressure reducing valve function into one unit), or it may be a combination of a pressure reducing valve and a back pressure valve (as shown in Figure 4 of Chinese Patent Publication CN2023106604381), or it may be a set of mutually cooperating mass flow controllers (as shown in Figure 9 of Chinese Patent Publication CN2023106604381).

[0122] In some embodiments, the gas storage section (172) includes at least one gas storage channel (1720). The gas storage channel (1720) has a sufficiently small cross-sectional area to minimize diffusion between gases (i.e., reduce diffusion at the interface between the nitric oxide gas stored in the gas storage channel (1720) and the air input from the power source). The cross-sectional area of ​​the gas storage channel is less than 20 cm², preferably less than 4 cm², and more preferably less than 1 cm². Furthermore, in order to make full use of the gas storage space of the gas storage section (172) and minimize its overall space occupation, the port for inputting / outputting nitric oxide gas in the gas storage section (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).

[0123] In some embodiments, the intake unit is connected to the inlet (1710) of the reaction chamber (171) via a pipe equipped with a first flow control device (176) that regulates the flow rate of the reaction gas entering the reaction chamber (171). The first flow control device (176) may also be located downstream of the outlet (1711) of the reaction chamber (171). The first flow control device (176) may be a mass flow controller (MFC).

[0124] In some embodiments, the delivery unit may further include a second flow control device (177) located on the gas delivery section (3) to regulate the flow rate of the outflow gas. The second flow control device (177) may also be a mass flow controller (MFC).

[0125] In some embodiments, the delivery unit may further include a filter device (178) located on the gas delivery section (173), which is designed to filter NO2 from the product gas. The filter device (178) is detachably connected to the gas delivery section (173). The filter device (178) may include an inlet and an outlet, each connected to the gas delivery section (173). In addition, the delivery unit may include a detection branch (179) located on the gas delivery section (173). One end of the detection branch (179) is connected to the gas delivery section (173), and the other end is open to the environment, allowing measurement of the nitric oxide concentration in the gas delivery section (173). The detection branch (179) may include an air resistance (1790) and a nitric oxide sensor (1791) arranged sequentially from near the gas delivery section (173) to away from the gas delivery section (173). The air resistance is designed to prevent a large amount of gas from escaping into the environment through the detection branch (179), allowing only a small amount of gas to pass through to the sensor.

[0126] In some embodiments, the NO preparation and delivery system of FIG. 17 may also include a sampling detection unit (3000), which may include a detection gas path (3100) and a sampling gas path (3200). The detection gas path (3100) is connected to the sampling gas path (3200). One end of the sampling gas path (3200) is connected to the inhalation branch (2001) of the breathing device (2000), and the other end is connected to the detection gas path (3100) through a water trap (3201). The water trap (3201) is designed to filter moisture in the sampling gas to prevent damage to downstream sensors or to avoid affecting the detection results.

[0127] In some embodiments, one end of the detection gas path (3100) is connected to a water trap (3201), and the other end is open to the environment. The detection gas path (3100) is equipped with a sampling gas pump (3101) and a sensor unit (3102). The sampling gas pump (3101) provides power for sampling, while the sensor unit (3102) may include sensors such as a nitric oxide sensor, a nitrogen dioxide sensor, an oxygen sensor, etc., for detecting NO, NO2, O2, etc., in the gas that the patient is about to inhale.

[0128] In some embodiments, the filtration device (178) in FIG. 17 may accommodate multiple independent filtration chambers to achieve different filtration functions. For example, one filtration chamber contains calcium hydroxide filter media and is connected to the gas delivery section (173) for removing NO2 from the gas. Another filtration chamber contains potassium permanganate filter media for removing exhaust gas, and its outlet is connected to the environment.

[0129] When the pressure control unit (175) is a pressure reducing valve with a pressure relief function, its pressure relief port can also be connected to the chamber of the filter device (178) via a pipeline for discharging waste gas. This arrangement prevents untreated gas from being directly discharged into the environment when the product gas is discharged from the pressure relief port through the filter device (178).

[0130] In some embodiments, a shut-off valve is installed upstream of the filter device (178) on the gas delivery section (173). When the filter device (178) reaches the end of its service life, there is no need to stop the machine for replacement. The filter device (178) can be directly disassembled and replaced, and the shut-off valve closes immediately when the filter device (178) is disassembled to maintain a stable internal pressure within the equipment. When a new filter device (178) is reinserted, the filter device (178) opens the shut-off valve, allowing the gas delivery section (173) to reconnect with the filter device (178) and allowing the NO treatment gas to be output normally. The shut-off valve can also be a solenoid valve.

[0131] In some embodiments, the NO preparation and delivery system in FIG17 may also include a pressure relief unit. The pressure relief unit specification (pages 13 / 16, CN 121358517 A) may include a pressure relief conduit. One end of this conduit may 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 filter device (178) and the flow control unit (176). For example, a solenoid valve may be installed on the pressure relief conduit. When the device stops outputting NO, opening the solenoid valve allows NO to be quickly discharged from the system, preventing NO from remaining in the system for a long time and oxidizing to NO2. This also helps to balance the internal and external pressures of the system, extending the life of the device. Another method is to open the solenoid valve while simultaneously stopping the arc after NO output stops, using air from the intake unit to purge NO gas from the system. When NO output stops, the gas path inside the system contains air. The other end of the pressure relief conduit may be connected to the chamber of the filter device (178) for removing exhaust gas.

[0132] In summary, the NO preparation and delivery system in Figure 17 offers at least the following technical advantages compared to existing solutions:

[0133] 1) An internally integrated gas source eliminates reliance on external gas sources, making the device suitable for various application scenarios and facilitating device connection, operation, or relocation;

[0134] 2) The internally integrated gas source treats the humidity of the incoming air, reducing the impact of moisture on the NO generation efficiency in the arc reaction chamber;

[0135] 3) The internally integrated gas source treats the humidity of the incoming air, reducing the generation of more impurity gases after water vapor enters the arc reaction chamber;

[0136] 4) The internally integrated gas source treats the humidity of the incoming air, reducing the possibility of water vapor condensation inside the system and preventing the corrosion of the system by acidic liquids formed when NO2 dissolves in water;

[0137] 5) The internally integrated gas source treats the humidity of the incoming air, reducing the impact of water vapor entering the filter on the filtering effect of impurity gases on the filter material;

[0138] 6) After the device is shut down, release the internal pressure of the system to balance the internal and external pressures and extend the life of the device;

[0139] 7) After treatment is stopped, purge the device to ensure that the internal gas path of the device is filled with air, to prevent NO from remaining in the system and being oxidized to NO2, which would affect the patient's subsequent treatment;

[0140] 8) The shut-off valve allows the filter to be replaced without stopping the device, without depressurizing the device, and without leaking NO treatment gas, reducing the time that treatment is interrupted due to filter replacement.

[0141] In the design of high-performance and reliable gas storage systems, many technical challenges have emerged. A key requirement for gas storage compartments is to make the cross-sectional area of ​​their chambers as uniform as possible. Maintaining a minimum cross-sectional area is crucial for minimizing the mixing and dispersion of fluids between adjacent parts of the container. Traditional methods, such as the use of long pipes and similar pipe configurations, often require a large installation space. While strategies such as winding and stacking help optimize space utilization, they are inadequate when dealing with special fluids, including corrosive gases or liquids such as NO, NO2, and nitric acid. For these substances, conventional hose materials are insufficient, requiring the use of materials such as PTFE and other high-fluorine materials. However, the inherent rigidity of these materials also presents a series of challenges, especially when container installation space is strictly limited. This rigidity limits the feasibility of compact winding or stacking, increasing the risk of pipe damage and dead zones within the cavity. Therefore, there is an urgent need for a compact gas storage solution that provides a high volumetric space ratio and effectively reduces the mixing and dispersion of fluids in adjacent internal sections.

[0142] Figures 18 and 19 show schematic diagrams of the gas storage section according to an embodiment of this disclosure. The designs in Figures 18 and 19 include a compact structure with a high effective volume ratio, corrosion-resistant materials, and minimal internal fluid mixing.The structural design minimizes the mixing and dispersion of internal fluids by employing a series of continuous pipes with a uniform cross-section throughout the process. To optimize volume ratio, these pipes have a uniform thickness and interconnect between adjacent channels through small perforations in their walls. Considering practical manufacturing techniques, the perforation cross-sectional area can be less than 1 cm² 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.

[0143] In nature, honeycomb structures (comprising nearly hexagonal structures with efficient connections that maximize the utilization of wall thickness between each) represent the most efficient use of space. Inspired by this, honeycomb structures made of corrosion-resistant metals or plastics can be manufactured, as shown in Figures 18 and 19, with partial sidewall openings between adjacent holes to form a continuous (approximate) cross-sectional pipe container. The structure is sealed at both ends with mesh corrosion-resistant gaskets and end caps, allowing for a compact volume while maintaining continuous cross-sectional channels.

[0144] The difference between Figures 18 and 19 lies in the cross-sectional shape of the cavity of the gas storage section. When the manufacturing process uses a machine, the cross-section of each channel is designed to be elliptical to optimize compatibility with machining tools. This approach produces the cross-sectional shape shown in Figure 18. However, this design choice results in reduced efficiency in the utilization of wall thickness between adjacent channels.

[0145] Conversely, when using injection molding technology, the cross-sectional shape of each channel is a regular hexagon. This approach ensures that the interior cavity of the entire gas storage section has a uniform wall thickness, as shown in Figure 19. This configuration maximizes the utilization of internal space.

[0146] Considering the practical manufacturing process and maximizing space utilization, the end caps of the gas storage section can be removable, with each end sealed using a mesh gasket, as shown in Figure 20. The gasket presses against the ribs (i.e., wall thickness) between the channels. Gas enters from one end, flows to the other end, and then returns in the opposite direction through adjacent channels opened on the sidewalls, forming a serpentine flow that connects the entire channel in one direction, similar to a series of uniformly thick-walled pipes closely arranged within the structure.

[0147] Depending on the actual installation method, the gas inlet and outlet may be located differently, but it is desirable to ensure that each channel is fully utilized. Openings on the sidewalls between adjacent channels should be as close to the ends as possible to minimize dead zones and prevent gas stagnation in these areas. The size of these openings should not be too large or too small, and ideally should match the cross-sectional area of ​​the channel. Openings that are too large will cause the fluid to disperse and mix as it passes through, while openings that are too small will generate excessive resistance, affecting the normal flow of gas. Except for the channels connecting the gas inlet and outlet, the sidewalls at both ends of the remaining channels will open to adjacent channels, but will not open to the same adjacent channels at both ends.The channel near the side wall of the container may have an opening to the outside for sensor mounting, allowing monitoring of internal conditions such as pressure and temperature by sensors mounted at the opening.

[0148] The foregoing description is for illustrative purposes. It is not exhaustive and is not limited to the precise forms or embodiments disclosed. Modifications and adjustments to the embodiments will be apparent from consideration of the description and practice of the disclosed embodiments. For example, the described implementations include hardware, but systems and methods consistent with this disclosure can be implemented in both hardware and software. Furthermore, while some components are described as being connected to each other, these components may be integrated with each other or distributed in any suitable manner.

[0149] The design of the gas storage section shown in Figures 18 and 19 has several technical advantages. First, these structural designs significantly improve the efficiency of gas storage by reducing the volume of the gas container. These designs achieve this by maximizing the volume of the piping within a compact footprint, addressing a key challenge in gas container design. In addition, these structures greatly reduce the volume occupied by conventional piping coiling methods, facilitating easy installation and secure fixation of the gas container.

[0150] Furthermore, these structures offer more options in terms of materials and design while ensuring corrosion resistance, making them easier to manufacture and produce. Despite their compact size, the structure does not compromise performance. It retains key advantages, such as preventing gas mixing and diffusion, ensuring the integrity and efficiency of gas utilization.

[0151] Of particular note is the application of these structures in NO therapeutic gas delivery devices. They cleverly manage the storage and release of NO gas to meet the different needs of the user's respiratory cycle. During exhalation, these structures temporarily store excess NO gas, while during inhalation, when the demand for NO increases, they release the stored gas. This mechanism helps to balance the real-time production and consumption of NO gas, preventing mixing and diffusion with the driving gas or its oxidation to NO2. Therefore, these structures improve the safety and effectiveness of nitric oxide therapy devices and expand their application range. Specification 15 / 16 pages 19 CN 121358517 A

[0152] In a practical setting, the therapeutic gas delivery devices described herein are used to administer NO therapeutic gas to a ventilator. The gas is mixed before being inhaled by the patient. For example, a patient requiring a tidal volume of 500 ml to inhale NO at a concentration of 10 ppm ideally receives a 1:9 mixture of NO gas and ventilator air. Therefore, the therapeutic gas delivery device needs to deliver 50 ml of NO gas at a concentration of 100 ppm. The 35 ml gas storage section within the therapeutic gas delivery device can achieve this while maintaining an internal pressure of 0.5 bar (gauge pressure), as the pressure in the inspiratory limb of the ventilator is relatively low and negligible.Alternatively, a 25 ml gas storage section within a therapeutic gas delivery device can achieve the same goal while maintaining an internal pressure of 1 bar. This highlights the device's compact and lightweight nature, greatly enhancing its compatibility with ventilators and other medical devices.

[0153] If the mixing ratio in the above example is too high, the oxygen from the ventilator may be undesirably diluted. On the other hand, a lower mixing ratio results in less NO gas being released, which allows for the use of a smaller gas storage section but requires a higher NO gas concentration within the device. This necessitates a more complex production process, especially if an electric arc technique is used, which increases NO2 production. Therefore, there is an optimal range for mixing NO gas with air in therapeutic gas delivery devices.

[0154] Another key point is the relationship between pressure and volume within the gas storage section: higher pressure means a smaller volume is required, but also places higher demands on the system's sealing and reliability.

[0155] Furthermore, the patient's tidal volume directly affects the required size of the gas storage section. Some individuals may have tidal volumes exceeding 1000 ml, or even 1500 ml. In a preferred embodiment, the volume of the gas storage section is designed to be smaller than the patient's tidal volume. Adjusting the mixing ratio, storage section pressure, and NO concentration can help minimize the required volume of the gas storage section.

[0156] Empirical testing has shown that in the most efficient model, the volume of the gas storage section should be less than 1500 ml; ideally less than 1200 ml; more ideally less than 1000 ml; and even more ideally less than 800 ml. In some cases, a volume of less than 200 ml is sufficient. The preferred cross-sectional area of ​​the gas storage section is between 1 mm² and 4 cm², including the extreme values; preferably less than 2 cm², including the extreme values.

[0157] While exemplary embodiments have been described herein, the scope includes any and all embodiments based on this disclosure that have equivalent elements, modifications, omissions, combinations (e.g., aspects of various embodiments), adaptations, or alterations. Furthermore, the steps of the disclosed methods can be modified in any way, including reordering steps or inserting or deleting steps.

[0158] The features and advantages of this disclosure will become apparent from the detailed description. Furthermore, since many modifications and variations are readily apparent from the study of this disclosure, it is not intended to limit this disclosure to the exact constructions and operations shown and described. Therefore, all suitable modifications and equivalents may be made, and these modifications and equivalents are all within the scope of this disclosure.

[0159] It is 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-described computer-readable medium. When executed by a processor, the software can perform at least some steps of the disclosed method.

[0160] In the foregoing specification, numerous specific details have been described with reference to which may vary from embodiment to embodiment. Certain adjustments and modifications may be made to the embodiments. Other embodiments will be readily apparent to those skilled in the art from practice of the specification and the disclosure herein. The specification and examples are intended to be illustrative only, and the true scope and spirit of the disclosure are indicated by the following claims. It is also intended that the order of steps shown in the figures is for illustrative purposes only and is not intended to imply that all steps must be performed for any given method of operation or to be limited to any particular order of steps. Therefore, those skilled in the art will understand that these steps may be performed in different orders when implementing the same method. Furthermore, the devices shown in the figures are merely illustrative, and a given device or system may include different combinations of components or modules of such devices. Instruction Manual Page 16 / 16 20 CN 121358517 A Figure 1 Figure 2 Instruction Manual Figure 1 / 13 Page 21 CN 121358517 A Figure 3 Figure 4 Instruction Manual Figure 2 / 13 Page 22 CN 121358517 A Figure 5 Figure 6 Instruction Manual Figure 3 / 13 Page 23 CN 121358517 A Figure 7 Instruction Manual Figure 4 / 13 Page 24 CN 121358517 A Figure 8 Instruction Manual Figure 5 / 13 Page 25 CN 121358517 A Figure 9 Figure 10 Instruction Manual Figure 6 / 13 Page 26 CN 121358517 A Figure 11 Figure 12 Instruction Manual Figure 7 / 13 Page 27 CN 121358517 A Figure 13 Figure 14 Instruction Manual Figure 8 / 13 Page 28 CN 121358517 A Figure 15 Figure 16 Instruction Manual Figure 9 / 13 Page 29 CN 121358517 A Figure 17 Appendix to the Specification 10 / 13 Page 30 CN 121358517 A Figure 18 Appendix to the Specification 11 / 13 Page 31 CN 121358517 A Figure 19 Appendix to the Specification 12 / 13 Page 32 CN 121358517 A Figure 20 Appendix to the Specification 13 / 13 Page 33 CN 121358517 A.

Claims

1. A therapeutic gas delivery system, comprising: a therapeutic gas source configured to generate a therapeutic gas; a gas storage section connected downstream of the therapeutic gas source, the gas storage section configured to store at least a portion of the therapeutic gas from the therapeutic gas source; a gas output section connected downstream of the gas storage section, the gas output section configured to output the therapeutic gas on demand; a replenishment section connected to the gas storage section, the replenishment section configured to replenish the gas storage section with gas; and a flow control unit coupled to the gas output section, the flow control unit configured to control an amount of therapeutic gas delivered through the gas output section.

2. The therapeutic gas delivery system of claim 1, further comprising: a pressure control unit connected to the gas storage section, the pressure control unit configured to stabilize a pressure within the gas storage section.

3. The therapeutic gas delivery system of claim 2, wherein the pressure control unit is configured to stabilize the pressure within the gas storage section at a preset value greater than 120 cmH20.

4. The therapeutic gas delivery system of claim 2, wherein the gas output section is configured to deliver the therapeutic gas to a breathing apparatus, and the pressure control unit is configured to maintain the pressure within the gas storage section higher than a pressure in an inspiratory limb of the breathing apparatus.

5. The therapeutic gas delivery system of claim 2, wherein: when the replenishment section is connected to a power source, the pressure control unit comprises a back pressure valve, wherein the back pressure valve is configured to: release gas in the gas storage section through a relief port of the back pressure valve to stabilize the pressure within the gas storage section when the pressure within the gas storage section exceeds a preset value.

6. The therapeutic gas delivery system of claim 5, wherein: when the power source connected to the replenishment section comprises a high pressure gas cylinder or a gas pump, the pressure control unit comprises a combination of a pressure reducing valve and a back pressure valve, wherein: the pressure reducing valve is configured to stabilize an input pressure from the power source.

7. The therapeutic gas delivery system of claim 2, wherein: the pressure control unit comprises a valve assembly that provides both pressure reducing and back pressure functions.

8. The therapeutic gas delivery system of claim 2, wherein: the pressure control unit comprises a first mass flow controller further coupled to the replenishment section to control a flow rate of gas replenished to the gas storage section by the replenishment section.

9. The therapeutic gas delivery system of claim 8, wherein: a relief gas path is configured between the first MFC and the gas storage section, wherein the relief gas path comprises a second MFC configured to control a flow rate of gas released from the gas storage section to stabilize the pressure within the gas storage section.

10. The therapeutic gas delivery system of claim 2, wherein: The pressure control unit comprises a combination of a pressure sensor and an electrically controlled valve, wherein: the pressure sensor is configured to detect the pressure in the gas storage section, and the electrically controlled valve is configured to control an opening based on the detected pressure to regulate the gas flow through the opening.

11. The therapeutic gas delivery system of claim 10, wherein: the electrically controlled valve comprises a solenoid valve or a proportional valve.

12. The therapeutic gas delivery system of claim 1, wherein: when the patient downstream of the gas output section is in an exhalation phase or the flow rate of the therapeutic gas output to the patient by the gas output section is less 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 into the gas storage section.

13. The therapeutic gas delivery system of claim 12, wherein: when the flow rate of the therapeutic gas output to the patient by the gas output section exceeds the flow rate provided by the therapeutic gas source, the therapeutic gas stored in the gas storage section is spontaneously output to the gas output section.

14. The therapeutic gas delivery system of claim 1, wherein: the gas replenished by the replenishment section comprises air, nitrogen or the therapeutic gas.

15. The therapeutic gas delivery system of claim 1, wherein: the inlet of the replenishment section is connected to a power source ensuring the driving force for replenishing gas into the gas storage section, wherein the power source comprises a high pressure gas cylinder, a hospital central gas source or a gas pump.

16. The therapeutic gas delivery system of claim 1, wherein: the cross-sectional area of the gas storage section is between 1 mm2and 4 cm2, inclusive.

17. The therapeutic gas delivery system of claim 1, wherein: the replenishment section is further connected to the therapeutic gas source and configured to replenish gas to the therapeutic gas source.

18. The therapeutic gas delivery system of claim 1, wherein: the therapeutic gas source comprises an electrochemical on-the-spot preparation device for electrochemically generating nitric oxide, and the replenishment section is further configured to input a purge gas into the therapeutic gas source for purging the electrodes and carrying out the electrochemically generated NO, wherein the purge gas comprises air or nitrogen.

19. The therapeutic gas delivery system of claim 1, wherein: the therapeutic gas source comprises an on-the-spot preparation device for generating NO using the arc method, and the replenishment section is configured to input a reaction gas into the therapeutic gas source, wherein the electrodes within 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 portion of the reaction gas.

20. The therapeutic gas delivery system of claim 19, wherein: the reaction gas comprises air or oxygen-containing nitrogen gas.

21. The therapeutic gas delivery system of claim 1, wherein: the replenishment section is configured to be connected to both the gas storage section and the therapeutic gas source and to input gas into both the gas storage section and the therapeutic gas source by a power source.

22. The therapeutic gas delivery system of claim 1, wherein: the supply portion includes a first supply portion connected to the gas storage portion and a second supply portion connected to the therapeutic gas source, wherein the first and second supply portions are connected to different power sources to deliver different gases into the gas storage portion and the therapeutic gas source, respectively.

23. The therapeutic gas delivery system of claim 22, wherein: the first supply portion is configured to input air into the gas storage portion; and the second supply portion is configured to input nitrogen into the therapeutic gas source.

24. The therapeutic gas delivery system of claim 1, further comprising: a second flow control unit installed downstream of the therapeutic gas source to control the flow rate of therapeutic gas output from the therapeutic gas source.

25. The therapeutic gas delivery system of claim 1, further comprising: a second flow control unit installed upstream of the therapeutic gas source to control the flow rate of gas into the therapeutic gas source.

26. The therapeutic gas delivery system of claim 1, wherein the therapeutic gas comprises one or more of NO, CO, H2S, or H2.

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