Equipment, systems, and methods for transporting therapeutic gases

Abstract

This disclosure describes a therapeutic gas delivery device. The therapeutic gas delivery device includes a therapeutic gas source configured to generate a therapeutic gas, and a gas storage unit connected downstream of the therapeutic gas source. The gas storage unit is configured to store at least a portion of the therapeutic gas from the therapeutic gas source. The device also includes a gas delivery unit connected downstream of the gas storage unit, which is configured to deliver the therapeutic gas on demand. The device also includes a replenishment unit connected to the gas storage unit, which is configured to replenish the gas storage unit with gas. The device further includes a pressure control unit connected to the gas storage unit, which is configured to stabilize the pressure in the gas storage unit. The device also includes a flow control unit connected to the gas delivery unit, which is configured to control the amount of therapeutic gas delivered by the gas delivery unit.

Description

[Technical Field]

[0001] Cross-references of related applications This application claims priority based on a Chinese provisional application filed on June 6, 2023, with application number 2023106604381, the entire contents of which are incorporated into this application by reference.

[0002] This disclosure relates to the technical field of medical devices, and more particularly to a therapeutic gas delivery system for administering therapeutic gases on demand. [Background technology]

[0003] Inhalation therapy involves supplying therapeutic gases to patients using devices such as ventilators to achieve therapeutic effects. Taking nitric oxide (NO) gas as an example, recent studies have revealed that nitric oxide plays a crucial role in transmitting important signals and regulating cellular function within the human body. Nitric oxide can contribute to promoting blood circulation. It can diffuse without intermediary mechanisms, permeate biological membranes, and transmit information generated in one cell to surrounding cells. Nitric oxide possesses various biological functions and readily participates in electron transfer reactions and biological oxidation-reduction processes. Direct inhalation therapy with nitric oxide is approved by the United States Food and Drug Administration as a treatment for persistent pulmonary hypertension in neonates, demonstrating its ability to improve the body's oxygenation capacity and reduce the need for high-risk extracorporeal life support in critically ill patients. Controllable and appropriate doses of nitric oxide can specifically reduce pulmonary hypertension and improve oxygenation. Currently, nitric oxide inhalation therapy is widely used in neonatal respiratory medicine, as well as in intensive care, thoracic surgery, respiratory medicine, anesthesiology, and other clinical medical fields.

[0004] Therapeutic gases (e.g., nitric oxide) are typically used in conjunction with respiratory equipment (e.g., ventilators and anesthesia machines). The gas is delivered to the inhalation lines of these devices and then inhaled by the patient for use in gas inhalation therapy. Respiratory-gated therapeutic gas delivery is a preferred method of administering therapeutic gases because it delivers the therapeutic gas in accordance with the patient's respiratory rate (i.e., synchronizes the administration of the therapeutic gas with the patient's respiratory pattern). Compared to conventional therapeutic gas delivery, the respiratory-gated approach can maintain a stable concentration of the inhaled therapeutic gas throughout the entire respiration period and can significantly reduce the impact of changes in respiratory pattern and parameters on the concentration of the inhaled therapeutic gas.

[0005] Because respiratory flow rates fluctuate significantly throughout a patient's entire respiratory cycle, achieving respiratory synchronization requires the rapid delivery of a specific volume of therapeutic gas within a short timeframe. For devices that generate therapeutic gas on demand, matching the instantaneous amount of therapeutic gas generated with the instantaneous amount of transport required is a challenge, and this poses a significant obstacle to realizing respiratory-synchronized transport functionality in therapeutic gas generators.

[0006] The therapeutic gas delivery device and system described in this application can be applied to ventilators from different manufacturers and different ventilator modes, and can be perfectly compatible with anesthesia machines and extracorporeal membrane oxygenation (ECMO) devices. The therapeutic gas delivery device and system described in this application can meet the requirements for accuracy and stability of therapeutic gas concentration for different patient groups (adults, children, and neonates) with different tidal volumes and respiratory rates, particularly the requirements during high-frequency vibration ventilation.

[0007] Some conventional on-demand generation devices are designed to enable respiratory-gated transport. As disclosed in the PCT application with publication number WO2022127902A, a “pressure vessel” is installed downstream of the therapeutic gas generator and upstream of the therapeutic gas transport pipeline. This pressure vessel is a large-capacity gas storage tank that can withstand a constant pressure and stores excess therapeutic gas generated, and can function using the pressure from the therapeutic gas stored in the tank. In this way, when it is necessary to rapidly deliver a large amount of therapeutic gas in a short time, this pressure is used to deliver the therapeutic gas stored in the tank, supplementing consumption that cannot be supplied in a timely manner in the case of on-demand generation.

[0008] Such container-based systems have drawbacks. For example, when it is necessary to deliver a large flow rate of therapeutic gas from a tank, pressure fluctuations within the tank can affect the flow rate of the delivered therapeutic gas, resulting in a deviation of the concentration of the transported therapeutic gas from the specified value. The larger the capacity of the storage tank, the better the effect of preventing pressure fluctuations when delivering at high flow rates. In some cases requiring normal flow rates, the storage tank needs to be very large to avoid the above-mentioned defects. This severely limits the miniaturization of the equipment and restricts the application of on-demand therapeutic gas generators. Another drawback is that if 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 to toxic NO2, and if on-demand prepared NO remains in a large storage tank for a long time, the NO2 content increases, impairing the quality of the delivered therapeutic gas. [Overview of the Initiative] [Means for solving the problem]

[0009] In some embodiments of this disclosure, devices for generating and / or administering therapeutic gases (e.g., nitric oxide (NO)) are provided.

[0010] In one embodiment, a therapeutic gas delivery device includes a therapeutic gas source (1), which is configured to generate a therapeutic gas. The therapeutic gas delivery device further includes a gas storage unit (2) connected downstream of the therapeutic gas source (1), which is configured to store at least a portion of the therapeutic gas from the therapeutic gas source (1). The therapeutic gas delivery device further includes a gas delivery unit connected downstream of the gas storage unit (2), which is configured to deliver the therapeutic gas as needed. The therapeutic gas delivery device further includes a replenishment unit (4) connected to the gas storage unit (2), which is configured to replenish the gas storage unit (2) with gas. The system further includes a pressure control unit (5) connected to the gas storage unit (2), which is configured to stabilize the pressure within the gas storage unit (2). The therapeutic gas delivery device further includes a flow control unit (6) connected to a gas delivery unit (3), the flow control unit (6) being configured to control the amount of therapeutic gas delivered by the gas delivery unit (3).

[0011] Embodiments of a therapeutic gas delivery device have one or more of the following features: A pressure control unit (5) is configured to maintain the pressure in the gas reservoir (2) stably at a predetermined value greater than 120 centimeters of water column. A gas delivery unit is configured to deliver therapeutic gas to a respiratory device, and the pressure control unit (5) is configured to maintain the pressure in the gas reservoir (2) higher than the pressure at the inspiratory branch of the respiratory device. If the patient downstream of the gas delivery unit (3) is in the expiratory phase, or if the flow rate of therapeutic gas delivered from the gas delivery unit (3) to the patient is less than the flow rate of therapeutic gas provided by the therapeutic gas source (1), at least a portion of the therapeutic gas provided by the therapeutic gas source (1) is stored in the gas reservoir (2).

[0012] If the flow rate of therapeutic gas delivered to the patient from the gas delivery unit (3) is greater than the flow rate provided by the therapeutic gas source (1), the therapeutic gas stored in the gas storage unit (2) is spontaneously delivered to the gas delivery unit (3).

[0013] The gas supplied by the replenishment unit (4) includes air or therapeutic gas. The inlet of the replenishment unit (4) is connected to a power source to ensure the driving force to replenish the gas storage unit (2), and the power source includes a high-pressure cylinder, a hospital's central gas supply source, or an air pump.

[0014] When the replenishment unit (4) is connected to a power source, the pressure control unit (5) includes a back pressure valve (5a), which is configured to release gas from the gas storage unit (2) through its pressure release port when the pressure in the gas storage unit (2) exceeds a predetermined value, in order to stabilize the pressure in the gas storage unit (2).

[0015] If the power source connected to the replenishment unit (4) includes a high-pressure cylinder or air pump, the pressure control unit (5) includes a combination of a pressure reducing valve (5b) and a back pressure valve (5a), the pressure reducing valve (5b) being configured to stabilize the pressure supplied from the power source.

[0016] The pressure control unit (5) includes a valve assembly that combines a pressure reduction function and a back pressure function. The pressure control unit (5) includes a first mass flow controller (MFC), which is connected to a replenishment unit (4) and controls the flow rate of gas replenished from the replenishment unit (4) to the gas storage unit (2). A pressure release gas passage is located between the first MFC and the gas storage unit (2), and the pressure release gas passage includes a second MFC, which is configured to control the flow rate of gas released from the gas storage unit (2) and stabilize the pressure inside the gas storage unit (2).

[0017] The pressure control unit (5) includes a combination of a pressure sensor and an electrically controlled valve, the pressure sensor being configured to detect pressure in the gas reservoir (2), and the electrically controlled valve being configured to regulate the gas flow through the opening by controlling the opening based on the detected pressure. The electrically controlled valve includes a solenoid valve or a proportional valve.

[0018] The cross-sectional area of ​​the gas storage section is 1 mm². 2 More than 4cm 2The following applies: The replenishment unit (4) is further connected to the therapeutic gas source (1) and configured to replenish the therapeutic gas source (1) with gas. The therapeutic gas source (1) includes an electrochemical preparation device that electrochemically generates nitric oxide (NO), and the replenishment unit (4) is further configured to supply a purge gas to the therapeutic gas source (1) to purge the electrodes and remove the electrochemically generated NO, the purge gas containing air or nitrogen gas.

[0019] The therapeutic gas source (1) includes a preparation device for generating NO using an arc method, and the replenishment unit (4) is configured to supply reaction gas to the therapeutic gas source (1). The electrodes in the reaction chamber of the therapeutic gas source (1) are for generating NO by high-voltage discharge, and the generated NO is removed in excess of the reaction gas.

[0020] The reaction gas includes air or an oxygen-nitrogen-containing gas. The replenishment unit (4) is connected to the gas storage unit (2) and the therapeutic gas source (1), respectively, and is configured to supply gas to the gas storage unit (2) and the therapeutic gas source (1) by a power source. The replenishment unit (4) includes a first replenishment unit connected to the gas storage unit (2) and a second replenishment unit connected to the therapeutic gas source (1), and the first and second replenishment units are configured to be connected to different power sources, respectively, to transport different gases to the gas storage unit (2) and the therapeutic gas source (1).

[0021] The first replenishment unit is configured to supply air to the gas storage unit (2), and the second replenishment unit is configured to supply nitrogen gas to the therapeutic gas source (1).

[0022] The therapeutic gas administration system further includes a second flow rate control unit (7) attached downstream of the therapeutic gas source (1), and the second flow rate control unit (7) is configured to control the flow rate of the therapeutic gas delivered from the therapeutic gas source (1). The therapeutic gas administration system further includes a second flow rate control unit (7) attached upstream of the therapeutic gas source (1), and the second flow rate control unit (7) is configured to control the flow rate of the gas entering the therapeutic gas source (7).

[0023] The above summary and the following detailed description are merely illustrative and explanatory and do not limit the disclosed embodiments to be protected.

[0024] The drawings are part of this specification. The drawings show some embodiments of the present disclosure and are for interpreting the principles of some of the disclosed embodiments according to the claims together with the description.

Brief Description of the Drawings

[0025] [Figure 1] It is a schematic diagram of a therapeutic gas administration device according to the first embodiment of the present disclosure.

[0026] [Figure 2] It is a schematic diagram of a therapeutic gas administration device according to the second embodiment of the present disclosure.

[0027] [Figure 3] It is a schematic diagram of a therapeutic gas administration device according to the third embodiment of the present disclosure.

[0028] [Figure 4] It is a schematic diagram of a therapeutic gas administration device according to the fourth embodiment of the present disclosure.

[0029] [Figure 5] It is a schematic diagram of a therapeutic gas administration device according to the fifth embodiment of the present disclosure.

[0030] [Figure 6]Schematic diagrams of electrochemical time preparation apparatus according to several embodiments of the present disclosure.

[0031] [Figure 7] Schematic diagrams of time preparation devices for arc methods according to several embodiments of the present disclosure.

[0032] [Figure 8] This is a schematic diagram of a nitric oxide (NO) supply unit in a respiratory device according to a first embodiment of the present disclosure.

[0033] [Figure 9] This is a schematic diagram of an NO supply unit in a respiratory device according to a second embodiment of the present disclosure.

[0034] [Figure 10] This is a schematic diagram of an NO supply unit in a respiratory device according to a second embodiment of the present disclosure.

[0035] [Figure 11] This is a schematic diagram of an NO supply unit in a respiratory device according to a third embodiment of the present disclosure.

[0036] [Figure 12] This is a schematic diagram of an NO supply unit in a respiratory device according to a fourth embodiment of the present disclosure.

[0037] [Figure 13] This is a schematic diagram of an NO supply unit in a respiratory device according to a fifth embodiment of the present disclosure.

[0038] [Figure 14] This is a schematic diagram of an NO supply unit in a respiratory device according to a sixth embodiment of the present disclosure.

[0039] [Figure 15] This is a schematic diagram of an NO supply unit in a respiratory device according to a seventh embodiment of the present disclosure.

[0040] [Figure 16] This is a schematic diagram of an NO supply unit attached to a respiratory device via a mounting groove, according to some embodiments of the present disclosure.

[0041] [Figure 17] Schematic diagrams of NO preparation and transport systems according to some embodiments of the present disclosure.

[0042] [Figure 18] This is a schematic diagram of a gas storage section according to an embodiment of the present disclosure.

[0043] [Figure 19] This is another schematic diagram of a gas storage section according to an embodiment of the present disclosure.

[0044] [Figure 20] This is another schematic diagram of a gas storage section according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0045] The disclosed embodiments are described in detail below. Unless otherwise specified, technical and scientific terms have the meanings that are ordinarily understood by those skilled in the art. The disclosed embodiments are described in sufficient detail to enable those skilled in the art to implement them. Other embodiments may be adopted, and modifications may be made without departing from the scope of the disclosed embodiments. Therefore, the materials, methods, and examples are for illustrative purposes only and are not necessarily intended to limit them.

[0046] Figure 1 is a schematic diagram of a therapeutic gas delivery device according to a first embodiment of the present disclosure. As shown in Figure 1, the therapeutic gas delivery device includes a therapeutic gas source (1), a gas storage unit (2), a gas delivery unit (3), a replenishment unit (4), a pressure control unit (5), and a flow rate control unit (6).

[0047] The therapeutic gas source (1) is configured to generate therapeutic gases such as NO, CO, H2S, and H2 as needed.

[0048] The gas storage unit (2) is connected downstream of the therapeutic gas source (1) and is configured to store the therapeutic gas supplied by the therapeutic gas source (1).

[0049] The gas delivery unit (3) is connected downstream of the therapeutic gas source (1) and can transport the therapeutic gas to the patient.

[0050] The replenishment unit (4) is connected to the gas storage unit (2), and the replenishment unit (4) replenishes gas into the gas storage unit (2).

[0051] The pressure control unit (5) is connected to the gas reservoir (2) and configured to maintain a stable pressure within the gas reservoir (2) at a predetermined value. In some embodiments, the predetermined value is generally greater than 120 centimeters of water column. Maintaining a stable pressure within the gas reservoir (2) at a predetermined value ensures that the pressure within the gas reservoir (2) is higher than the pressure in the inspiratory branch of the ventilator, allowing the therapeutic gas in the gas reservoir (2) to be spontaneously delivered into the ventilator tubing. A higher predetermined pressure value allows for a greater maximum flow rate achievable by the therapeutic gas delivery device, thereby improving the respiratory synchronization effect. However, as the pressure value increases, so does the reliability requirement for the device.

[0052] The flow control unit (6) is located at or upstream of the gas delivery unit (3) and is configured to control the amount or flow rate of the therapeutic gas administered to the patient.

[0053] If a patient downstream of the gas delivery unit (3) is in the exhalation phase, or if the amount of gas transported from the gas delivery unit (3) to the patient is less than the amount of gas supplied by the therapeutic gas source (1), the excess therapeutic gas enters the gas storage unit (2), and the gas storage unit (2) stores all or part of the excess therapeutic gas.

[0054] If the amount of gas transported from the gas delivery unit (3) to the patient exceeds the amount supplied by the therapeutic gas source (1), the therapeutic gas stored in the gas storage unit (2) will spontaneously transfer to the gas delivery unit (3). The gas replenished from the replenishment unit (4) to the gas storage unit (2) may be air or therapeutic gas. The inlet of the replenishment unit (4) may be connected to a power source to provide sufficient driving force to replenish the gas in the gas storage unit (2). For example, the power source may be a high-pressure cylinder, a central gas supply source in a hospital, or an air pump.

[0055] There are various forms in which the pressure control unit (5) can be implemented. In the first embodiment shown in Figure 1, when the replenishment unit (4) is connected to a stable and controllable power source, the pressure control unit (5) may be a back pressure valve. When new therapeutic gas is introduced into the gas storage unit (2) and the gas pressure in the gas storage unit (2) exceeds a predetermined value, the gas is discharged from the gas storage unit (2) through the pressure release port of the back pressure valve in order to maintain a stable pressure in the gas storage unit (2).

[0056] In the second embodiment shown in Figure 2, when the power source connected to the replenishment unit (4) is a high-pressure cylinder or air pump, the pressure control unit (5) includes a pressure reducing valve (5b) and a back pressure valve (5a). The pressure reducing valve (5b) reduces and stabilizes the pressure from the power source. If the gas pressure in the gas storage unit (2) exceeds a predetermined value, gas is discharged from the gas storage unit (2) through the pressure release port of the back pressure valve (5a) to maintain a stable pressure in the gas storage unit (2).

[0057] In the third embodiment shown in Figure 3, some valve devices / assemblies combine both pressure reduction and back pressure functions. Therefore, by installing such a valve assembly (5c) in the gas storage section (4), the same effects as those of the pressure reducing valve (5b) and back pressure valve (5a) in the second embodiment can be achieved.

[0058] In addition to the mechanical valve configuration described above, the pressure control unit may also employ a mass flow controller (MFC) or other configuration. For example, by installing a first mass flow controller in the replenishment section (4), the mass flow rate of the gas replenished in the gas storage section (2) is controlled. A pressure-releasing gas passage is arranged between the first mass flow controller and the gas storage section (2), and a second mass flow controller is installed in the pressure-releasing gas passage to control the mass flow rate of the discharged gas, thereby achieving the effect of maintaining a stable pressure within the gas storage section (2).

[0059] In some embodiments, the pressure control unit (5) may employ a combination of a pressure sensor and an electrically controlled valve (e.g., a solenoid valve, a proportional valve, etc.). The pressure sensor detects the pressure in the gas reservoir (2), and the electrically controlled valve controls the size of the gas flow passing through the opening by adjusting the opening based on the detected pressure value. For example, if a low pressure is detected, the gas flow passing through is reduced. The pressure sensor may be located downstream of the gas reservoir (2), but the delay in detecting pressure changes due to flow rate adjustment by the electrically controlled valve is disadvantageous for pressure control.

[0060] In some embodiments, the pressure control unit (5) is mounted on the replenishment unit (4) or on the gas storage unit (2). Generally, it is not recommended to place the pressure control unit (5) near the gas outlet unit (3). This is because, when excess therapeutic gas is introduced into the gas storage unit (2), the pressure control unit (5) will discharge some of the already stored gas from the gas storage unit (2) to make space for the newly introduced therapeutic gas. If the pressure control unit (5) is too close to the gas outlet unit (3), the actual volume of the gas storage unit (2) available for storing therapeutic gas is reduced. To maximize the usable volume of the gas storage unit (2) and minimize its size, it is preferable to mount the pressure control unit (5) on the replenishment unit (4).

[0061] In some embodiments, the range of the cross-sectional area S of the gas storage section (2) is 1 mm2 More than 4cm 2 The following applies: If the cross-sectional area S is close to or below the lower limit, air resistance increases, making it difficult to achieve the effect of rapid gas transport. If the cross-sectional area S is close to or above the upper limit, the diffusion of the therapeutic gas intensifies, mixing at the interface between the therapeutic gas and the supplemental gas intensifies, affecting the concentration of the delivered therapeutic gas and reducing the utilization efficiency of the generated therapeutic gas.

[0062] In the fourth embodiment shown in Figure 4, the replenishment unit (4) may be connected to the therapeutic gas source (1) to replenish the therapeutic gas source (1) with gas.

[0063] In some embodiments, when the therapeutic gas source (1) is an electrochemical preparation device that generates NO by an electrochemical method, the replenishment unit (4) supplies a purge gas (air, nitrogen gas, etc.) to purge the electrodes and remove the NO gas generated by the electrochemical method.

[0064] Figure 6 shows an exemplary electrochemical preparation apparatus. As shown in Figure 6, the exemplary electrochemical preparation apparatus includes a reaction chamber (11), which comprises a gas region and a liquid region. The liquid region is for containing the reaction medium (12), and the gas region is for containing the product gas containing NO. An electrode (13) is in contact with the reaction medium (12), and NO gas can be generated in the reaction chamber (11) by applying a predetermined current or voltage through the electrode (13). A purge gas inlet (14) introduces a purge gas into the reaction medium (12) to purge the NO gas generated in the reaction medium (12). The purge gas is air, nitrogen gas, etc. The reaction medium (12) also includes a buffer, a nitrite ion source, and a catalyst, the catalyst containing a metal-ligand complex, and the nitrite ion source containing one or more nitrites. For example, the composition of the reaction medium (12) refers to the content disclosed in a Chinese patent, publication number CN114318357A, published on April 12, 2022, which discloses an electrolyte, a corresponding electrolytic cell, and an electrolytic method for achieving high-concentration delivery of NO. The content of the Chinese application with publication number CN114318357A is incorporated by reference in this application. Exemplary embodiments of an electrochemical preparation apparatus for generating NO can refer to the content disclosed in a Chinese application, publication number CN110831640A, published on February 21, 2020, which discloses a nitric oxide generation system for a gas dosing apparatus. The content of the Chinese application with publication number CN110831640A is also incorporated by reference in this application.

[0065] In some embodiments, when a ready-to-use preparation device that generates NO using an arc method is used as the therapeutic gas source (1), the replenishment unit (4) can supply a reaction gas (air, oxygen-nitrogen-containing gas, etc.). Figure 7 shows an exemplary ready-to-use preparation device using an arc method. As shown in Figure 7, the ready-to-use preparation device using an arc method includes a reaction chamber (21) and includes one or more electrodes (22) in the reaction chamber (21). The electrodes in the reaction chamber (21) of the therapeutic gas source (1) generate NO by high-voltage discharge, and the generated NO is carried out by the excess reaction gas. The ready-to-use preparation device further includes a reaction gas inlet (23) through which the reaction gas inlet (23) is introduced into the reaction chamber (21). The reaction gas may be air. The electrodes (22) are configured to generate a product gas from the reaction gas using a high-voltage circuit, and the product gas contains a desired amount of NO.

[0066] Referring to Figure 4, the replenishment unit (4) is connected to the gas storage unit (2) and the therapeutic gas source (1), respectively, and a power source supplies the same type of gas (e.g., air) to the gas storage unit (2) and the therapeutic gas source (1), respectively. Alternatively, two replenishment units (4) may be installed, each connected to the gas storage unit (2) and the therapeutic gas source (1), respectively, and connected to different power sources to transport different gases, for example, supplying air to the gas storage unit (2) and supplying nitrogen gas to the therapeutic gas source (1).

[0067] Furthermore, a flow rate control unit (7) may be installed downstream of the therapeutic gas source 1 in order to control the flow rate of the therapeutic gas delivered from the therapeutic gas source 1.

[0068] The flow rate control unit (7) may be installed upstream of the therapeutic gas source (1), and as shown in the fifth embodiment in Figure 5, it controls the flow rate of the gas entering the therapeutic gas source 1.

[0069] The therapeutic gas delivery device shown above and in Figures 1-7 differs from conventional NO generation and delivery systems and methods in the following respects. For example, a Chinese patent with publication number CN110573454B describes a system and method for generating NO (e.g., paragraph

[0227] of the specification and Figures 19-25). The structure referred to in CN110573454B includes a buffer tank, a piston, a diaphragm, and a diaphragm drive, which together form a temporary storage structure through which NO gas is delivered. In the design disclosed in CN110573454B, a buffer tank of a certain volume is required to store NO gas, thus limiting the miniaturization of the device. Furthermore, the delivery of NO gas relies on mechanical structures such as a piston and a diaphragm, which experience friction and wear during operation. The operation of the piston and diaphragm is controlled by signal transmission, which presents challenges to the immediacy and reliability of the system's operation.

[0070] The technical proposal described herein can solve the above limitations of CN110573454B. For example, the power source that drives the delivery of NO gas from the gas storage unit (2) is the stable pressure within the gas storage unit (2). The medium that drives the delivery of NO gas is the replenishment gas that is filled into the gas storage unit (2) from the replenishment unit (4) (the interface between the replenishment gas and the NO gas within the gas storage unit (2) can be approximately considered as a piston). No signal transmission or other form of control is required during the NO gas delivery process from the gas storage unit (2), and delivery can be achieved instantaneously by pressure. Furthermore, if replenishment gas is used as the medium during the delivery process, no friction or wear occurs.

[0071] As described above, the therapeutic gas delivery device described in this application has at least the following technical advantages. First, it enables respiratory-gated gas delivery in a sufficiently small device size. The miniaturization and lightweight design significantly reduces limitations imposed by therapeutic design and facilitates integration with other therapeutic devices.

[0072] Furthermore, because the gas storage section is relatively small, the long-term accumulation of NO gas is minimized, and the generation of NO2 gas within the gas storage section is also minimized.

[0073] Furthermore, the therapeutic gas delivery device described in this application does not require control or adjustment via complex electromagnetic components or signal transmission, and therefore has no wear-out parts. This contributes to the high reliability and immediacy of the device.

[0074] Another significant advantage is the effective utilization of the therapeutic gas generated by the device. Compared to the “gas storage tank” technology mentioned in the background art and Chinese patent with publication number CN110573454B, the device according to this disclosure has a shorter rise time when delivering the therapeutic gas. In a system with a gas storage tank, NO gas and air are mixed uniformly in the initial stage, and then the NO delivery concentration is stabilized. In contrast, the device according to this application uses a system based on a gas storage unit with a relatively small diameter and volume. With such a design, when introducing NO gas, the original gas in the gas storage unit can be quickly discharged, and the desired NO concentration can be rapidly adjusted within 1-2 breathing cycles. As a result, the concentration rise time is shorter, the response speed is faster, and the therapeutic gas delivery device is more efficient and responsive.

[0075] The therapeutic gas delivery devices shown in Figures 1 to 7 are incorporated into a respiratory apparatus or system as nitric oxide (NO) supply units. Exemplary respiratory apparatuses (Figures 8 to 16) and exemplary respiratory systems (Figure 17) are described below. Respiratory apparatus with nitric oxide (NO) supply unit

[0076] As described in the background technology, respiratory-gated therapeutic gas delivery requires the rapid injection of a constant flow rate of therapeutic gas based on the respiratory rate, flow rate, and pressure of a device such as a ventilator or anesthesia machine. In some cases, the flow rate needs to reach 120 L / min or more in a short period of time.

[0077] To achieve respiratory-gated transport, a gas storage container with a constant pressure and capacity is placed upstream of the therapeutic gas supply pipeline. This gas storage container stores therapeutic gas at the appropriate time and releases the stored therapeutic gas when the inhalation flow rate increases rapidly in a short period of time, thereby compensating for any shortage in the flow rate for on-demand preparation and transport of the therapeutic gas unit.

[0078] Conventional NO therapy devices that achieve respiratory-gated delivery are typically relatively large in volume and weight. When used in combination with respiratory equipment (e.g., ventilators), the NO therapy device requires dedicated installation space. This is a disadvantage in environments with very limited space, such as ICUs. When used alone, conventional NO therapy devices are difficult to apply to situations where portability is required, such as in home or outdoor environments, due to their volume and weight limitations.

[0079] To address the technical challenges of conventional designs, the therapeutic gas delivery devices shown in Figures 1-7 are used as nitric oxide (NO) supply units in the respiratory apparatus.

[0080] A first embodiment of the NO supply unit is shown in Figure 8. As shown in Figure 8, the NO supply unit includes a housing (1000). The housing (1000) includes a reaction chamber (81) having an inlet (810) and an outlet (811). The reaction chamber (81) further includes an electrode (812). A reaction gas stream (usually air) can enter through the inlet (810), and the electrode (812) generates the reaction gas stream passing through the reaction chamber (81) as a nitric oxide product gas, and releases the gas stream containing the product gas from the outlet (811).

[0081] The housing (1000) further includes 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 specific timings. The housing (1000) further includes a gas transport section (83) located downstream of the outlet (811). The gas transport section (83) is configured to transport the gas stream containing the product gas to the outside of the housing (1000).

[0082] The housing (1000) further includes a power source (84) connected to the gas storage section (82), thereby maintaining a stable internal gas pressure within the gas storage section (82).

[0083] If the flow rate from the gas transport unit (83) to the outside of the housing (1000) is less than the flow rate supplied from the outlet (811) to the gas transport unit (83), the excess gas is introduced into the gas storage unit (82), thereby storing at least a portion of the excess gas. If the flow rate from the gas transport unit (83) to the outside of the housing (1000) exceeds the flow rate supplied from the outlet (811) to the gas transport unit (83), the gas stored inside the gas storage unit (82) is guided to the gas transport unit (83).

[0084] Furthermore, the housing (1000) may be designed as a removable assembly that is incorporated into the breathing apparatus (2000).

[0085] A gas transport connection port (1001) is located in the housing (1000), and the gas transport connection port (1001) is connected to the gas transport unit (83). The breathing apparatus (2000) has a connection port that is connected in correspondence with the gas transport connection port (1001) and is also connected to the inspiratory branch line (2001) of the breathing apparatus (2000).

[0086] In the first embodiment of the NO supply unit shown in Figure 8, an intake port (1002) is located in the housing (1000). The breathing apparatus (2000) has a connection port that corresponds to the intake port (1002), and this connection port is connected to the internal gas passage of the breathing apparatus (2000). The inlet (810) of the reaction chamber (81) is connected to the intake port (1002) and supplies a reaction gas flow to the reaction chamber (81) via the internal gas passage of the breathing apparatus (2000). The gas storage section (82) is also connected to the intake port (1002) and receives gas via the internal gas passage of the breathing apparatus (2000), and the intake port (1002) functions as a power source (84).

[0087] Furthermore, the power source (84) shown in Figure 8 includes a pressure control device (85) configured to maintain a stable internal gas pressure in the gas reservoir (82). The pressure control device (85) may be a pressure reducing valve with a pressure release function (substantially integrating the functions of a back pressure valve and a pressure reducing valve into one unit), a combination of a pressure reducing valve and a back pressure valve (for example, as shown in Figure 4 of the Chinese application with publication number CN2023106604381), or a pair of cooperating mass flow controllers (as shown in Figure 9 of the Chinese application with publication number CN2023106604381).

[0088] Figure 9 is a schematic diagram of an NO supply unit in a respiratory apparatus according to a second embodiment of the present disclosure. In the second embodiment shown in Figure 9, an inspiratory connection port (1002) is further disposed in the housing (1000). The respiratory apparatus (not shown in Figure 9, see 2000 in Figure 8) has a connection port which is connected in correspondence with the inspiratory connection port (1002) and which is connected to the internal gas passage of the respiratory apparatus. The inlet (810) of the reaction chamber (81) is connected to the inspiratory connection port (1002), which supplies a reaction gas flow to the reaction chamber (81) via the internal gas passage of the respiratory apparatus. The power source (84) includes an air pump (840) located within the housing (1000). The air pump (840) is connected to a gas reservoir (82) and configured to supply gas to the gas reservoir (82). Furthermore, the power source further includes a pressure control device (85), and a pressure control device similar to that of the first embodiment (see Figure 8) can be used.

[0089] Figure 10 is a schematic diagram of an NO supply unit in a respiratory apparatus according to a third embodiment of the present disclosure. In the third embodiment shown in Figure 10, an inspiratory port (1002) is located in a housing (1000). The respiratory apparatus (not shown in Figure 9, see 2000 in Figure 8) includes a port connected to the inspiratory port (1002), the port being connected to an internal gas passage of the respiratory apparatus. The inlet (810) of the reaction chamber (81) is connected to the inspiratory port (1002), which supplies a reaction gas flow to the reaction chamber (81) via the internal gas passage of the respiratory apparatus.

[0090] Furthermore, the housing (1000) shown in Figure 10 further has a gas supply connection port (1003). The breathing apparatus has a connection port that is connected to the gas supply connection port (1003), and this connection port is connected to the internal gas passage of the breathing apparatus. The gas storage unit (82) is connected to the gas supply connection port (1003), and the gas supply connection port (1003) supplies gas to the gas storage unit (82) via the internal gas passage of the breathing apparatus and also functions as a power source (84). The power source (84) further includes a pressure control device (85) according to the first and second embodiments.

[0091] Figure 11 is a schematic diagram of an NO supply unit in a respiratory apparatus according to a fourth embodiment of the present disclosure. In the fourth embodiment shown in Figure 11, the housing (1000) does not have an intake connection port (1002 shown in Figures 8 to 10) or a gas supply connection port (1003 shown in Figures 8 to 10). A first air pump (8100) is installed inside the housing (1000), and the intake port (810) of the reaction chamber (81) is connected to the first air pump (8100), and the first air pump (8100) 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 unit (82) and is configured to supply gas to the gas storage unit (82). The power source (84) further includes a pressure control device (85) according to the above embodiment.

[0092] Figure 12 is a schematic diagram of an NO supply unit in a respiratory apparatus according to a fifth embodiment of the present disclosure. In the fifth embodiment shown in Figure 12, the housing (1000) does not have an intake connection port (1002 shown in Figures 8 to 10) or a gas supply connection port (1003 shown in Figures 8 to 10). A second air pump (8100) is installed inside the housing (1000), and the intake port (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). The gas storage unit (82) is also connected to the second air pump (8100), which supplies gas to the gas storage unit (82) and functions as a power source (84). The power source (84) also includes a pressure control device (85) according to the above embodiment.

[0093] Figure 13 is a schematic diagram of an NO supply unit in a respiratory apparatus according to a sixth embodiment of the present disclosure. In the sixth embodiment shown in Figure 13, the housing (1000) does not have an inspiratory connection port (1002). An air pump (8100) is installed inside the housing (1000), and the inspiratory port (810) of the reaction chamber (81) is connected to the air pump (8100), and the air pump (8100) supplies a reaction gas flow to the reaction chamber (81). A gas supply connection port (1003) is provided in the housing (1000). The respiratory apparatus (not shown in Figure 9, see 2000 in Figure 8) has a connection port that is connected to the gas supply connection port (1003), and this connection port is connected to an internal gas passage of the respiratory apparatus. The gas storage unit (82) is connected to a gas supply connection port (1003), which supplies gas to the gas storage unit (82) via an internal gas passage in the breathing apparatus and functions as a power source (84). The power source (84) also includes a pressure control device (85) according to the above embodiment.

[0094] In embodiments of this disclosure, the gas storage section (82) includes at least one gas storage passage (820). The gas storage passage (820) has a sufficiently small cross-sectional area, thereby minimizing the diffusion phenomenon between gases (i.e., suppressing diffusion at the interface between the nitric oxide gas stored in the gas storage passage (820) and the air supplied by the power source). The cross-sectional area S of the gas storage passage is 1 mm². 2 ≤S ≤ 4cm 2 It will be set within the range.

[0095] In addition to the various forms of power sources (84) mentioned in the above embodiments, other forms may be implemented. For example, the power source (84) may be of the form of a piston cylinder, and the gas reservoir (82) may be integrated into the piston cylinder. The pressure inside the gas reservoir (82) is controlled by driving the piston rod to change the spatial volume inside the gas reservoir (82). Compared to other forms according to the above embodiments, the piston cylinder structure has several disadvantages: (1) Volume effect: The internal space of the module housing is limited, and the form of a piston cylinder leads to an increase in the overall volume of the module. (2) Reliability: The piston rod of the piston cylinder needs to be driven repeatedly, which is a reliability issue. (3) Delay: The timing of driving the piston rod needs to be controlled by signal feedback, which leads to a delay, and as a result the internal pressure of the gas reservoir (82) does not match the desired pressure, affecting the accuracy of nitric oxide delivery. (4) Noise. (5) Power consumption.

[0096] As another example, the power source (84) may be in the form of a gas bag. In this case, the gas storage section (82) can use an expandable and contractible gas bag structure as the power source (84). In particular, the power source is the force that restores the deformation of the gas bag structure. This method has some drawbacks; for example, repeated deformation of the gas bag leads to fatigue and wear, limiting its service life.

[0097] In embodiments of the NO supply unit according to this disclosure, a first flow control device (86) (see Figure 8, but applicable to all embodiments described) is installed in an upstream pipeline connected to the inlet (810) of the reaction chamber (81) to control the flow rate of the reaction gas entering the reaction chamber (81). In some embodiments, the first flow control device (86) may be a mass flow controller (MFC).

[0098] Furthermore, a second flow control device (87) (see Figure 8, but applicable to all embodiments) is attached to the gas transport section (83) to control the flow rate of the outflowing gas. The second flow control device (87) may also be a mass flow controller (MFC).

[0099] As an example of the embodiment shown in Figure 8 (applicable to all embodiments described), a filtration device (88) for filtering NO2 from the product gas is attached to the gas transport unit (83). The filtration device (88) is detachably connected to the gas transport unit (83). The filtration device (88) has an inlet and an outlet, each connected to the gas transport unit (83).

[0100] Using the embodiment shown in Figure 8 as an example (applicable to all embodiments described), the filter (88) is located outside the housing (1000). The housing (1000) is provided with connection ports for inserting the inlet and outlet of the filter (88), and the connection ports inside the housing (1000) are connected to the gas transport unit (83). Alternatively, the filter (88) may be mounted inside the housing (1000), close to the wall of the housing (1000), with a removable operating window provided in the housing (1000) at a position corresponding to the filter (88). The filter (88) is a consumable item, and over time, its filtration material (e.g., calcium hydroxide) requires periodic replacement. Installing the filter (88) outside the housing (1000) or close to the wall of the housing (1000) can facilitate replacement. Preferably, the filter (88) is installed upstream of the second flow control device (87). Since the filtration device (88) has a filtration chamber filled with filtration material, if installed upstream, it can contribute to guaranteeing the effectiveness of respiratory gating. If the filtration device (88) is installed downstream of the second flow control device (87), it may affect the flow rate and timing of the therapeutic gas delivered via the second flow control device (87) and passing through the filtration chamber, thus affecting the effectiveness of respiratory gating.

[0101] As an example of the embodiment shown in Figure 8 (applicable to all embodiments), a detection branch (89) is attached to the gas transport unit (83), with one end of the detection branch (89) connected to the gas transport unit (83) and the other end open to the environment. The detection branch (89) is configured to measure the concentration of nitric oxide in the gas transport unit (83). The detection branch (89) also includes an air resistance (890) and a nitric oxide sensor (891) arranged in order from the side closest to the gas transport unit (83) to the side furthest from it. The installation of the air resistance prevents a large amount of gas from escaping into the environment via the detection branch (89), while allowing a small amount of gas to pass through and reach the sensor.

[0102] In some embodiments, the detection branch (89) in the example shown in Figure 8 is located upstream of the second flow control device (87) and downstream of the filtration device (88). Ideally, to ensure that the monitored NO concentration is as close as possible to the actual discharge concentration, the detection branch (89) should be installed as close as possible upstream of the second flow control device (87). If the detection branch (89) is installed downstream of the second flow control device (87), the therapeutic gas may not be able to enter the detection branch (89), and the concentration of the therapeutic gas may not be detectable. If the detection branch (89) is installed upstream of the filtration device (88), the actual discharge concentration of NO will be relatively low.

[0103] In some embodiments, the NO supply unit shown in Figures 8 to 13 further includes a sampling detection unit (3000), the sampling detection unit (3000) including a detection gas channel (3100) located inside the housing (1000) and a sampling gas channel (3200) located outside the housing (1000). The detection gas channel (3100) is connected to the sampling gas channel (3200).

[0104] Using the embodiment shown in Figure 8 as an example (applicable to all embodiments described), the sampling gas channel (3200) is connected at one end to the inspiratory branch (2001) of the breathing apparatus (2000) and at the other end to the detection gas channel (3100) inside the housing (1000) via a water trap (3201). The water trap (3201) is primarily used to filter moisture from the sampling gas to prevent damage to downstream sensors or influence on detection results. Since the water trap (3201) needs to be removed periodically, it is located outside the housing (1000), and the housing (1000) is provided with a mounting base for attaching the water trap (3201).

[0105] In some embodiments, the detection gas channel (3100) is connected at one end to a water trap (3201) and the other end is open to the environment. A sampling air pump (3101) and a sensor unit (3102) are arranged in the detection gas channel (3100). The sampling air pump (3101) provides the power for sampling. The sensor unit (3102) includes sensors such as a nitric oxide sensor, a nitrogen dioxide sensor, and an oxygen gas sensor, which detect components such as NO, NO2, and O2 in the gas inhaled by the patient.

[0106] The sampling detection unit (3000) is an optional component in the NO supply unit. In the embodiments shown in Figures 14 and 15, the sampling detection unit (3000 shown in Figure 8) is not included. In some embodiments, the sampling detection unit (3000 shown in Figure 8) is a separate unit assembled with the breathing apparatus (2000 shown in Figure 8).

[0107] In some embodiments, a fan (referring to the fan 4000 shown in Figure 8 as an example) is placed in the housing (1000) shown in Figures 8 to 13. Using the embodiment shown in Figure 8 as an example (applicable to all embodiments described), the fan (4000) is located on the inner wall of the housing (1000), and a ventilation opening is provided in the housing (1000) at the location of the fan (4000). The fan (4000) may also be installed outside the housing (1000) and is primarily for cooling and ventilation.

[0108] For example, the end of the detection branch (89) that connects to the environment is connected to a fan (4000), thereby connecting the housing (1000) to the external environment. Similarly, the end of the detection gas flow path (3100) of the sampling detection unit (3000) that connects to the environment is also connected to a fan (4000), thereby connecting the housing (1000) to the external environment. The gas released into the environment from the detection branch (89) may contain the product gas nitric oxide, and if nitric oxide is easily oxidized to toxic nitrogen dioxide and accumulates inside the housing (1000), it could pose a safety hazard. Therefore, by connecting to the fan (4000), these gases can be discharged to the external environment as quickly as possible. Similarly, a certain amount of nitric oxide and nitrogen dioxide in the detection gas flow path (3100) of the sampling detection unit (3000) is also discharged to the external environment as quickly as possible by the fan (4000). Furthermore, the fan (4000) disperses these gases before they are discharged, thereby preventing the accumulation of exhaust gases such as NO and NO2. In some embodiments, the fan (4000) is an optional structure within the NO supply unit (see the embodiment without a fan shown in Figure 14).

[0109] In some embodiments, if the pressure control device (85) is a pressure reducing valve having a pressure release function, its pressure release port is also connected to the fan (4000) via a pipeline. The pressure release port may be in direct communication with the environment. Alternatively, the pressure release port may be connected to the inlet of the filtration device (88) via a pipeline.

[0110] Figure 16 is a schematic diagram of a portable NO supply device that can be attached to a respiratory device (2000) via a mounting groove (2002) according to several embodiments of the present disclosure. The respiratory device shown in Figure 16 is a portable NO supply device, and the housing (1000) is designed to be easily portable. The mounting groove (2002) is a configuration for attaching the portable NO supply device to the respiratory device (2000). Nitric oxide (NO) preparation and transport system

[0111] Figure 17 is a schematic diagram of a NO preparation and transport system according to several embodiments of the present disclosure. As shown in Figure 17, the NO preparation and transport system includes an intake unit for supplying air to the system and a reaction chamber (171) located downstream of the intake unit. The reaction chamber includes an inlet (1710), an outlet (1711), and an electrode (1712). The inlet (1710) is connected to the intake unit and receives a reaction gas flow (e.g., air). The electrode (1712) is configured to generate a nitric oxide product gas from the reaction gas flow passing through the reaction chamber (171). The outlet (1711) releases the gas flow containing the product gas.

[0112] The NO preparation and transport system shown in Figure 17 further includes a transport unit that delivers a gas stream containing the product gas to the outside of the system. The transport unit includes a gas storage unit (172), a gas transport unit (173), a gas replenishment unit (174), and a pressure control unit (175). As shown in Figure 17, the gas storage unit (172), located downstream of the outlet (1711), is configured to store at least a portion of the product gas from the outlet (1711) at specific timings. The gas transport unit (173), also located downstream of the outlet (1711), is configured to deliver a gas stream containing the product gas to the outside of the system. The gas replenishment unit (174) is connected at one end to an intake unit and at the other end to the gas storage unit (172), and is configured to replenish the gas storage unit (172) with gas. The pressure control unit (175) is connected to the gas storage unit (172) and is configured to maintain the pressure in the gas storage unit (172) at a predetermined value. One end of the gas replenishment unit (174) is further connected to an independent intake unit, thereby realizing the gas replenishment function.

[0113] In some embodiments, the inspiratory unit comprises one or more assemblies. For example, the inspiratory unit comprises an inspiratory filter which filters particulate matter, VOCs, etc., from the air to prevent damage to internal assemblies of the device (e.g., an air pump) or to prevent them from being inhaled by the patient. Downstream of the inspiratory filter, the inspiratory unit further comprises 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, supplies air to the reaction chamber (171) to generate NO, and provides a pressurized gas source to the system.

[0114] Downstream of the air pump, the intake unit further includes an air gas container, which suppresses fluctuations in the pulsating gas flow generated by the air pump and stabilizes the gas flow and the pressure generated by the intake unit.

[0115] The air pump provides a pressurized gas source, but it also generates water. When water enters the system, it can affect the generation of NO, a therapeutic gas, in the arc reaction chamber (171), and can also affect the absorption of NO2 by the system's filters. To solve this problem, an air dehumidification unit can be added. If the dehumidification unit is installed upstream of the air pump, water may be generated again after passing through the air pump. If the dehumidification unit is installed downstream of the air gas container, liquid water may already be formed downstream, requiring higher costs for the treatment of the liquid water. For this reason, it is preferable to position the dehumidification unit between the air pump and the air gas container, thereby rapidly reducing the humidity of the compressed gas source. The dehumidification method may be a Nafion tube method, or a method of filtering water or water vapor.

[0116] In some embodiments, the intake unit may further include a backpressure valve, thereby preventing the pipeline from bursting when the pressure of the intake unit is too high, and a pressure sensor for detecting the pressure of the intake unit may be added. When the pressure is too high, the gas suction may be stopped or reduced.

[0117] In some embodiments, when the flow rate sent from the gas transport section (173) to the outside of the system is smaller than the flow rate supplied from the outlet (1711) to the gas transport section (173), excess gas enters the gas storage section (172), and the gas storage section (172) stores at least a part of the excess gas. When the flow rate sent from the gas transport section (173) to the outside of the system is larger than the flow rate supplied from the outlet (1711) to the gas transport section (173), the gas stored inside the gas storage section (172) is guided to the gas transport section (173).

[0118] Also, the pressure control unit (175) may be a pressure reducing valve having a pressure relief function (substantially integrating the backpressure valve function and the pressure reducing valve function into one unit), may be a combination of a pressure reducing valve and a backpressure valve (for example, as shown in FIG. 4 in the Chinese application with publication number CN2023106604381), or may be a set of cooperating mass flow controllers (for example, as shown in FIG. 9 in the Chinese application with publication number CN2023106604381).

[0119] In some embodiments, the gas storage section (172) includes at least one gas storage passage (1720). The gas storage passage (1720) has a sufficiently small cross-sectional area, whereby the diffusion between gases can be minimized (that is, the diffusion at the interface between the nitrogen monoxide gas stored in the gas storage passage (1720) and the air supplied by the power source is suppressed). The cross-sectional area of the gas storage passage is less than 20 cm 2 and preferably less than 4 cm 2 and more preferably less than 1 cm 2It is less than [value missing]. Furthermore, in order to make full use of the gas storage space of the gas storage section (172) and to minimize the overall space it occupies, in the gas storage section (172), the port for introducing / discharging nitric oxide gas is located at one end of the gas storage passage (1720), and the port for connecting to the power source (174) is located at the other end of the gas storage passage (1720).

[0120] In some embodiments, the intake unit is connected to the inlet (1710) of the reaction chamber (171) via a conduit where a first flow control device (176) for regulating the flow rate of reaction gases entering the reaction chamber (171) is located. The first flow control device (176) may 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).

[0121] In some embodiments, the transport unit further includes a second flow control device (177) located in the gas transport section (3) for adjusting the flow rate of the outflowing gas stream. The second flow control device (177) may also be a mass flow controller (MFC).

[0122] In some embodiments, the transport unit further includes a filter (178) located in the gas transport section (173), designed to filter NO2 from the product gas. The filter (178) is detachably connected to the gas transport section (173). The filter (178) includes an inlet and an outlet, each connected to the gas transport section (173). The transport unit also further includes a detection branch (179) located in the gas transport section (173). The detection branch (179) has one end connected to the gas transport section (173) and the other end open to the environment, and is configured to measure the concentration of nitric oxide in the gas transport section (173). The detection branch (179) includes an air resistance (1790) and a nitric oxide sensor (1791) arranged in order from the side closest to the gas transport section (173) to the side furthest from the gas transport section (173). The air resistance is designed to prevent large amounts of gas from escaping into the environment from the detection branch (179) while allowing small amounts of gas to pass through and reach the sensor.

[0123] In some embodiments, the NO preparation and transport system shown in Figure 17 further includes a sampling detection unit (3000), which includes a detection gas channel (3100) and a sampling gas channel (3200). The detection gas channel (3100) is connected to the sampling gas channel (3200). One end of the sampling gas channel (3200) is connected to the inspiratory branch (2001) of a breathing apparatus (2000), and the other end is connected to the detection gas channel (3100) via a water trap (3201). The water trap (3201) filters out moisture in the sampling gas to prevent damage to downstream sensors or influence on the detection results.

[0124] In some embodiments, a detection gas channel (3100) is connected at one end to a water trap (3201) and open at the other end to the environment. A sampling air pump (3101) and a sensor unit (3102) are arranged in the detection gas channel (3100). The sampling air pump (3101) provides power for sampling. The sensor unit (3102) includes sensors such as a nitric oxide sensor, a nitrogen dioxide sensor, and an oxygen gas sensor, and is configured to detect NO, NO2, O2, etc., in the gas inhaled by the patient.

[0125] In some embodiments, the filtration device (178) shown in Figure 17 houses multiple independent filtration chambers to achieve different filtration functions. For example, one filtration chamber is filled with calcium hydroxide filter media and connected to a gas transport unit (173) to remove NO2 from the gas. Another filtration chamber is filled with potassium permanganate filter media and used to remove exhaust gas, with its outlet communicating with the environment.

[0126] If the pressure control unit (175) is a pressure reducing valve with a pressure release function, its pressure release port is connected to the chamber of the filtration device (178) via a pipeline and used to discharge exhaust gas. With such an installation, it is possible to prevent untreated gas from being directly released into the environment when the product gas is discharged from the pressure release port via the filtration device (178).

[0127] In some embodiments, a shut-off valve is installed in the gas transport unit (173) upstream of the filter (178). When the filter (178) reaches the end of its lifespan, it is not necessary to stop and replace it. The filter (178) can be directly removed and replaced, and when the filter (178) is removed, the shut-off valve closes immediately, maintaining a stable pressure within the equipment. When a new filter (178) is inserted, the filter (178) opens the shut-off valve, reconnecting the gas transport unit (173) and the filter (178), allowing the normal delivery of NO therapeutic gas. The shut-off valve may be a solenoid valve.

[0128] In some embodiments, the NO preparation and transport system shown in Figure 17 further includes a pressure relief unit. The pressure relief unit includes a pressure relief pipeline. One end of the pipeline is connected between the gas reservoir (172) and the pressure control unit (175), or between the gas reservoir (172) and the shut-off valve, or between the filter (178) and the flow control unit (176). For example, a solenoid valve is installed in the pressure relief pipeline. When the device stops delivering NO, opening the solenoid valve allows for the rapid discharge of NO from the system, preventing NO from remaining in the system for extended periods and being oxidized to NO2. This also helps to balance the internal and external pressures of the system and extend the life of the device. Another method is to open the solenoid valve and stop the delivery of NO, then stop the arc and remove the NO gas from the system using air from an intake unit. When the delivery of NO is stopped, there is air in the gas passages inside the system. The other end of the pressure relief pipe is connected to a chamber of a filtration device (178) for removing exhaust gas.

[0129] As described above, the NO preparation and transport system shown in Figure 17 has at least the following technical advantages compared to conventional designs.

[0130] (1) The gas source is integrated internally, eliminating reliance on an external gas source, which allows the device to be applied to various usage scenarios and contributes to the connection, operation, or movement of the device.

[0131] (2) By utilizing an internally integrated gas source, the humidity of the incoming air can be controlled, thereby suppressing the impact of moisture on the NO generation efficiency in the arc reaction chamber.

[0132] (3) By utilizing an internally integrated gas source, the humidity of the incoming air can be controlled, and the generation of more impurity gases after water vapor enters the arc reaction chamber can be suppressed.

[0133] (4) By utilizing an internally integrated gas source, the humidity of the incoming air can be treated, reducing the possibility of water vapor condensing inside the system and preventing corrosion of the system by acidic liquids formed when NO2 dissolves in water.

[0134] (5) By utilizing an internally integrated gas source, the humidity of the incoming air can be processed, and the impact of water vapor entering the filter on the effectiveness of filtering impurity gases from the filter material can be minimized.

[0135] (6) By releasing the internal pressure of the system after shutting down the device, the internal and external pressures are balanced, which can extend the lifespan of the device.

[0136] (7) After stopping treatment, the device can be purged and the gas passages inside the device filled with air to prevent NO from accumulating in the system and being oxidized to NO2, which could affect the patient's subsequent treatment.

[0137] (8) The shut-off valve allows the filter to be replaced without stopping the device, without reducing the pressure of the device, and without leakage of NO, which is a therapeutic gas, thus reducing the treatment interruption time caused by filter replacement.

[0138] Designing high-performance and reliable gas storage systems presents numerous technical challenges. A key requirement for gas storage chambers is to maintain as uniform a cross-sectional area as possible. Minimizing the cross-sectional area is crucial for minimizing fluid mixing and dispersion between adjacent sections within the container. Conventional methods, such as those using long pipelines and similar pipeline configurations, require very large installation spaces. While methods such as coiling and lamination can optimize space utilization efficiency, they are insufficient when handling special fluids (e.g., corrosive gases or liquids such as NO, NO2, and nitric acid). Conventional hose materials are unsuitable for these substances, requiring the use of materials such as PTFE and other high-fluorine materials. However, the inherent rigidity of these materials presents challenges, especially when the installation space for the container is severely limited. This rigidity limits the feasibility of compact coiling or lamination, increasing the risk of pipeline damage and the formation of dead zones within the chamber. Therefore, there is an urgent need to provide gas storage solutions that are compact, have a high volume-to-space ratio, and effectively suppress fluid mixing and dispersion between adjacent internal sections.

[0139] Figures 18 and 19 are schematic diagrams of a gas storage section according to an embodiment of the present disclosure. The design shown in Figures 18 and 19 includes a compact structure with a high effective volume ratio, is made of corrosion-resistant materials, and can minimize mixing of the internal fluid. The structural design minimizes mixing and dispersion of the internal fluid by using a series of continuous pipes that maintain a uniform cross-section throughout. To optimize the volume ratio, these pipes have a uniform thickness, and adjacent passages are connected to each other by drilling small holes in their walls. Considering actual manufacturing techniques, the cross-sectional area of ​​the holes is 1 cm² to prevent excessive fluid diffusion. 2It is less than [amount missing]. For example, materials such as polytetrafluoroethylene (PTFE), aluminum alloy, and stainless steel can be selected, and mechanical processing or injection molding can be used as the manufacturing process.

[0140] In nature, honeycomb structures (which consist of efficiently connected, roughly hexagonal structures that maximize the utilization of wall thickness between each structure) achieve the most efficient use of space. Based on this, honeycomb structures can be manufactured from corrosion-resistant metal or plastic. As shown in Figures 18 and 19, a conduit container with a continuous (approximate) cross-section is formed by leaving some of the side walls between adjacent holes open. Both ends of the structure are sealed with mesh-like corrosion-resistant sealing pads and end caps, thereby achieving a compact volume while maintaining a continuous cross-sectional passage.

[0141] Figures 18 and 19 differ in the cross-sectional shape of the gas storage chamber. When mechanical processing is used in the manufacturing process, the cross-section of each passage is designed to be elliptical to optimize compatibility with the processing tool. This method yields the cross-sectional shape shown in Figure 18. However, such a design leads to a decrease in the efficiency of utilizing the wall thickness between adjacent pipelines.

[0142] In contrast, when using injection molding technology, the cross-sectional shape of each passage is a regular hexagon. As shown in Figure 19, this method ensures that the entire inner chamber of the gas storage section has a uniform wall thickness. With this arrangement, the utilization efficiency of the internal space can be maximized.

[0143] Considering the actual manufacturing process and maximizing space utilization efficiency, as shown in Figure 20, the end caps of the gas reservoir are removable, and each end is sealed with a mesh sealing pad. The sealing pads are pressed against the ribs (i.e., wall thickness) between the passages. The gas enters from one end, flows to the other, and flows in the opposite direction through adjacent passages provided in the side walls, forming a meandering flow, similar to a series of pipes with uniform wall thickness, where the passages are continuously connected in one direction and densely arranged within the structure.

[0144] Depending on the actual installation method, the positions of the gas inlet and outlet can be designed differently, but it is desirable to ensure that each passage is fully utilized. Openings in the side walls between adjacent passages should be located as close to the ends as possible to minimize dead zones and prevent gas from accumulating in these areas. The size of these openings should not be too large or too small, and should match the cross-sectional area of ​​the passage. If the opening is too large, it may cause dispersion and mixing as the fluid passes through, and if the opening is too small, it will create too much resistance and affect the normal flow of gas. Except for the passage connecting the gas inlet and outlet, the side walls at both ends of other passages communicate with adjacent passages, but not both ends communicate with the same adjacent passage. Passages close to the side walls of the container have openings that communicate with the outside for the installation of sensors, and internal conditions such as pressure and temperature can be monitored by sensors installed at these openings.

[0145] The above is for illustrative purposes only, is not exhaustive, and is not limited to the exact forms or embodiments disclosed. Modifications and adjustments to the embodiments will be apparent when considering the specification and actual operation of the disclosed embodiments. For example, although the described implementations include hardware, the systems and methods relating to this disclosure can also be implemented using both hardware and software. Also, although some assemblies are described as being connected to one another, these assemblies may be integrated with one another or distributed in any suitable manner.

[0146] The gas storage designs shown in Figures 18 and 19 offer several technical advantages. First, these structural designs significantly improve gas storage efficiency by reducing the volume of the gas container. These designs are achieved by maximizing the volume of the pipeline within a compact installation area, solving a key challenge in gas container design. Furthermore, these structures drastically reduce the volume occupied by conventional pipeline winding methods, contributing to easy installation and secure fastening of the gas container.

[0147] Furthermore, while ensuring corrosion resistance, these structures offer more choices in terms of materials and design, making production and manufacturing easier. The structures are compact in size without compromising performance, retaining important advantages such as preventing gas mixing and diffusion, and ensuring the integrity and efficiency of gas utilization.

[0148] Of particular note is the use of these structures in NO therapeutic gas delivery devices. They cleverly manage the storage and release of NO gas to meet the varying needs of the user's respiratory cycle. During the expiratory phase, these structures temporarily store excess NO gas, and during the inspiratory phase, if the required NO increases, they release the stored gas. This mechanism contributes to balancing the real-time production and consumption of NO gas, preventing mixing and diffusion with the drive gas or oxidation to NO2. Therefore, these structures improve the safety and effectiveness of nitric oxide therapy devices and broaden their range of application.

[0149] In a real-world environment, the therapeutic gas delivery device described in this application is configured to deliver the therapeutic gas NO to a ventilator. The gas is mixed before the patient inhales it. For example, a patient inhaling NO at a concentration of 10 ppm with a tidal volume of 500 ml would ideally receive a mixture of NO gas and air from the ventilator in a 1:9 ratio. Therefore, the therapeutic gas delivery device needs to discharge 50 ml of NO gas at a concentration of 100 ppm. With a 35 ml gas reservoir in the therapeutic gas delivery device, this objective can be achieved while maintaining an internal pressure of 0.5 bar (gauge pressure). The pressure at the inspiratory branch of the ventilator is relatively low and negligible. Alternatively, with a 25 ml gas reservoir in the therapeutic gas delivery device, the same objective can be achieved while maintaining an internal pressure of 1 bar. This demonstrates the compact and lightweight characteristics of the device and significantly improves its compatibility with ventilators and other medical devices.

[0150] If the mixing ratio in the above example is too high, the oxygen gas in the ventilator may be diluted in an undesirable way. On the other hand, if the mixing ratio is relatively low, relatively little NO gas is released, and a relatively small gas reservoir can be used, but a relatively high NO gas concentration in the equipment is required. In this case, a more complex production method is required, and especially when using arc technology, the generation of NO2 increases. For this reason, there is an optimal range for mixing NO gas and air in therapeutic gas delivery devices.

[0151] Another important point is the relationship between pressure and volume within the gas storage area. Higher pressure requires less volume, but it also increases the demands for systemic sealing and reliability.

[0152] Furthermore, the patient's tidal volume directly affects the required size of the gas reservoir. The tidal volume of some patients can exceed 1000 milliliters (ml), and even 1500 ml. In a preferred embodiment, the volume of the gas reservoir is designed to be smaller than the patient's tidal volume. Adjusting the mixing ratio, reservoir pressure, and NO concentration can contribute to minimizing the required volume of the gas reservoir.

[0153] According to field tests, in the most effective model, the volume of the gas storage section is 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 may be sufficient. The cross-sectional area of ​​the gas storage section is preferably 1 mm². 2 More than 4cm 2 The following, preferably 2 cm 2 The following applies:

[0154] While this application describes exemplary embodiments, any embodiments, including equivalent elements, variations, omissions, combinations (e.g., aspects in each embodiment), modifications, or alterations based on the content of this disclosure, are included within its scope. Furthermore, the steps of the disclosed methods can be modified in any way, including by changing the order of steps or by adding or deleting steps.

[0155] The features and benefits of this disclosure will become clear from the detailed description. Furthermore, since numerous modifications and changes can be easily made by considering this disclosure, this disclosure is not intended to be limited to the specific structure and operation described. Accordingly, all appropriate modifications and equivalents can be used, and these modifications and equivalents are also included within the scope of this disclosure.

[0156] 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 on the above-mentioned computer-readable medium. When this software is executed by the processor, it performs at least some of the steps of the disclosed method.

[0157] The above specification refers to many specific details, and these specific details may vary depending on the embodiment. Certain adjustments and modifications can be made to the embodiments described. Other embodiments will become apparent to those skilled in the art from the practice of what is disclosed herein and in this application. The specification and examples are illustrative only, and the actual scope and spirit of this disclosure are given by the following claims. Furthermore, the order of steps shown in the figures is for illustrative purposes only, and not all steps are necessarily performed in the described operating method or in a specific order. Thus, those skilled in the art may perform these steps in a different order when carrying out the same method. Furthermore, the equipment shown in the drawings is for illustrative purposes only, and the equipment or system described may include different combinations of assemblies or modules of this equipment.

Claims

1. A therapeutic gas delivery system, It includes a therapeutic gas source, a gas storage unit, a gas delivery unit, a replenishment unit, and a flow rate control unit. The aforementioned therapeutic gas source is configured to generate therapeutic gas, The gas storage unit is connected downstream of the therapeutic gas source and is configured to store at least a portion of the therapeutic gas from the therapeutic gas source. The gas delivery unit is connected downstream of the gas storage unit and is configured to deliver the therapeutic gas upon request. The replenishment unit is connected to the gas storage unit and configured to replenish the gas storage unit with gas. The flow rate control unit is connected to the gas delivery unit and is configured to control the amount of therapeutic gas administered by the gas delivery unit. Therapeutic gas delivery system.

2. The system further includes a pressure control unit, which is connected to the gas storage unit and configured to stabilize the pressure within the gas storage unit. The therapeutic gas delivery system according to claim 1.

3. The pressure control unit is configured to stably maintain the pressure in the gas storage section at a predetermined value exceeding 120 centimeters of water column. The therapeutic gas delivery system according to claim 2.

4. The gas delivery unit is configured to administer the therapeutic gas to the respiratory device, and the pressure control unit is configured to maintain the pressure in the gas storage unit higher than the pressure at the inspiratory branch of the respiratory device. The therapeutic gas delivery system according to claim 2.

5. When the replenishment unit is connected to a power source, the pressure control unit includes a back pressure valve, which is configured to release gas from the gas storage unit through a pressure release port to stabilize the pressure in the gas storage unit when the pressure in the gas storage unit exceeds a predetermined value. The therapeutic gas delivery system according to claim 2.

6. If the power source connected to the replenishment unit includes a high-pressure cylinder or air pump, the pressure control unit includes a combination of a pressure reducing valve and a back pressure valve. The pressure reducing valve is configured to stabilize the pressure supplied from the power source. The therapeutic gas delivery system according to claim 5.

7. The pressure control unit includes a valve assembly that combines a pressure reduction function and a back pressure function. The therapeutic gas delivery system according to claim 2.

8. The pressure control unit includes a first mass flow controller, which is connected to the replenishment unit and controls the flow rate of gas supplied from the replenishment unit to the gas storage unit. The therapeutic gas delivery system according to claim 2.

9. A pressure-releasing gas passage is provided between the first MFC and the gas storage section, and the pressure-releasing gas passage includes a second MFC, which is configured to control the flow rate of gas released from the gas storage section and stabilize the pressure within the gas storage section. The therapeutic gas delivery system according to claim 8.

10. The pressure control unit includes a combination of a pressure sensor and an electrically controlled valve. The pressure sensor is configured to detect the pressure in the gas storage section. The electric control valve is configured to adjust the gas flow passing through the opening by controlling the opening based on the detected pressure. The therapeutic gas delivery system according to claim 2.

11. Electrically controlled valves include solenoid valves or proportional valves. The therapeutic gas delivery system according to claim 10.

12. If a patient downstream of the gas delivery unit is in the exhalation phase, or if the flow rate of therapeutic gas delivered from the gas delivery unit to the patient is less than the flow rate of therapeutic gas provided by the therapeutic gas source, at least a portion of the therapeutic gas provided by the therapeutic gas source is stored in the gas storage unit. The therapeutic gas delivery system according to claim 1.

13. If the flow rate of therapeutic gas delivered to the patient from the gas delivery unit is greater than the flow rate provided by the therapeutic gas source, the therapeutic gas stored in the gas storage unit is spontaneously delivered to the gas delivery unit. The therapeutic gas delivery system according to claim 12.

14. The gas supplied by the aforementioned supply unit includes air, nitrogen gas, or the aforementioned therapeutic gas. The therapeutic gas delivery system according to claim 1.

15. The inlet of the replenishment unit is connected to a power source to ensure the driving force to replenish the gas storage unit with gas, and the power source includes a high-pressure cylinder, a central gas supply source for a hospital, or an air pump. The therapeutic gas delivery system according to claim 1.

16. The cross-sectional area of ​​the gas storage section is 1 mm². 2 More than 4 cm 2 The following is The therapeutic gas delivery system according to claim 1.

17. The replenishment unit is further connected to the therapeutic gas source and configured to replenish the therapeutic gas source with gas. The therapeutic gas delivery system according to claim 1.

18. The therapeutic gas source includes an electrochemical preparation device that electrochemically generates nitric oxide. The replenishment unit is further configured to supply a purge gas to the therapeutic gas source in order to purge the electrodes and remove electrochemically generated NO, wherein the purge gas contains air or nitrogen gas. The therapeutic gas delivery system according to claim 1.

19. The therapeutic gas source includes a device for preparing NO on demand using an arc method. The replenishment unit is configured to supply reaction gas to the therapeutic gas source, and the electrodes in the reaction chamber of the therapeutic gas source 1 are for generating NO by high-voltage discharge, and the generated NO is removed from the excess portion of the reaction gas. The therapeutic gas delivery system according to claim 1.

20. The reaction gas includes air or an oxygen-nitrogen-containing gas. The therapeutic gas delivery system according to claim 19.

21. The replenishment unit is connected to the gas storage unit and the therapeutic gas source, respectively, and is configured to supply gas to the gas storage unit and the therapeutic gas source by a power source. The therapeutic gas delivery system according to claim 1.

22. The replenishment unit includes a first replenishment unit connected to the gas storage unit and a second replenishment unit connected to the therapeutic gas source, wherein the first and second replenishment units are connected to different power sources and are configured to transport different gases to the gas storage unit and the therapeutic gas source, respectively. The therapeutic gas delivery system according to claim 1.

23. The first replenishment unit is configured to supply air to the gas storage unit, The second replenishment unit is configured to supply nitrogen gas to the therapeutic gas source. The therapeutic gas delivery system according to claim 22.

24. The system further includes a second flow control unit installed downstream of the therapeutic gas source, the second flow control unit configured to control the flow rate of the therapeutic gas delivered from the therapeutic gas source. The therapeutic gas delivery system according to claim 1.

25. The system further includes a second flow control unit installed upstream of the therapeutic gas source, the second flow control unit configured to control the flow rate of gas entering the therapeutic gas source. The therapeutic gas delivery system according to claim 1.

26. The aforementioned therapeutic gases are NO, CO, H ２ S and H ２ Includes one or more of the following: The therapeutic gas delivery system according to claim 1.

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