CN118253003B

CN118253003B - Therapeutic gas delivery device

Info

Publication number: CN118253003B
Application number: CN202410444278.1A
Authority: CN
Inventors: 张煜彦; 张望坤; 孔祥海; 李渊; 王飞
Original assignee: Nanjing Nuoling Biotechnology Co ltd
Current assignee: Nanjing Nolong Biotechnology Co., Ltd.
Priority date: 2024-04-12
Filing date: 2024-04-12
Publication date: 2025-07-11
Anticipated expiration: 2044-04-12
Also published as: CN118253003A

Abstract

The present invention describes a therapeutic gas delivery device. The therapeutic gas delivery device may include a therapeutic gas source configured to generate therapeutic gas; and a gas storage unit connected downstream of the therapeutic gas source, the gas storage unit is configured to store at least part of the therapeutic gas from the therapeutic gas source, in addition, the device may also include a gas output unit connected downstream of the gas storage unit, the gas output unit is configured to output the therapeutic gas on demand, in addition, the device may also include a gas replenishing unit connected to the gas storage unit, configured to replenish the gas storage unit with gas, in addition, the device may also include a pressure control unit connected to the gas storage unit, used to stabilize the pressure inside the gas storage unit, in addition, the device may also include a flow control unit connected to the gas output unit, used to control the amount of therapeutic gas delivered through the gas output unit.

Description

Therapeutic gas delivery device

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a therapeutic gas conveying device for conveying therapeutic gas according to requirements.

Background

Inhalation therapy refers to the provision of therapeutic gas to a patient through a ventilator or the like to achieve a therapeutic effect. Taking Nitric Oxide (NO) gas as an example, nitric oxide has been found in recent years to play a role in transmitting important signals and regulating cellular functions in the human body. It helps to promote blood circulation in the body. Nitric oxide can diffuse rapidly through biological membranes without any intermediate mechanism, transferring information generated by one cell to surrounding cells. Nitric oxide has multiple biological functions and can participate in electron transfer reaction and redox process of human body at any time. Direct inhalation nitric oxide therapy has been approved by the U.S. food and drug administration as a treatment for neonatal sustained pulmonary hypertension, demonstrating that this therapy can increase oxygenation capacity of the body and reduce the need for high risk in vitro life support in critical patients. The control and proper amount of inhaled nitric oxide can effectively reduce pulmonary hypertension and improve oxygenation. At present, nitric oxide inhalation therapy is widely applied to neonatal respiratory medicine, and is also applicable to clinical medicine fields such as intensive care, cardiothoracic surgery, respiratory medicine, anesthesia department and the like.

Therapeutic gases such as nitric oxide are commonly used in conjunction with respiratory equipment such as ventilators and anesthetics. Therapeutic gas is delivered to the inhalation tubing of these devices and then inhaled by the patient for inhalation therapy. Respiratory follow-up therapeutic gas delivery is a preferred therapeutic gas delivery method because it delivers therapeutic gas according to the patient's respiratory flow rate (i.e., therapeutic gas delivery is synchronized with the patient's respiratory pattern). Compared with the traditional therapeutic gas delivery method, the respiratory following method can maintain stable inhaled therapeutic gas concentration in the whole respiratory process, and the influence of the respiratory mode and parameter variation on the inhaled therapeutic gas concentration is remarkably reduced.

Achieving breath tracking typically requires rapid delivery of a specific volume of therapeutic gas in a short period of time due to sustained and significant fluctuations in respiratory flow rate during patient breathing. For an instant therapeutic gas generating device, it is challenging to ensure that the instant therapeutic gas generated matches the instant required delivery consumption, which presents a significant challenge to the instant therapeutic gas generating device to achieve a breath-following delivery function.

The therapeutic gas delivery device described herein is perfectly compatible with different manufacturers' ventilators, different ventilator modes, even anesthesia machines and external membrane oxygenation (ECMO) devices. They also meet the accuracy and stability requirements of therapeutic gas concentrations for different populations, including adults, children and neonates, with varying tidal volumes and respiratory rates, particularly during high frequency oscillatory ventilation.

Some existing instant generating devices are designed to implement a breath following transmission function. As disclosed in PCT patent publication No. WO2022127902a, a "pressure vessel" is placed downstream of the therapeutic gas generating device and upstream of the therapeutic gas delivery conduit. The pressure vessel is a large-capacity gas storage tank capable of bearing a certain pressure and is used for storing the generated surplus therapeutic gas and relying on the pressure generated by the accumulated therapeutic gas in the tank. Thus, when a large amount of therapeutic gas needs to be rapidly output in a short time, the stored therapeutic gas can be output from the tank by means of the pressure, so that the consumption of the part of the instant preparation which cannot be generated in time can be compensated.

This container-based approach has drawbacks such as pressure fluctuations within the pressure vessel when a large flow of therapeutic gas is required to be delivered from the pressure vessel, thereby affecting the flow of therapeutic gas delivered, ultimately resulting in deviations in the concentration of therapeutic gas delivered. The greater the capacity of the pressure vessel, the better the effect of avoiding pressure fluctuations at high flow outputs, which requires that the pressure vessel must be very large to ensure that the above-mentioned drawbacks do not occur under some conventional flow demands. This greatly limits the miniaturization of the apparatus and also limits the applicable scenarios of the instant treatment gas generating device. Another disadvantage is that when the volume of the pressure vessel is large, therapeutic gas can accumulate within the vessel for a long period of time. Taking NO as an example, NO is easily oxidized to NO ₂, and too long a residence time of the instant NO in a high volume pressure vessel can result in an increase in NO ₂ content, thereby affecting the quality of the output therapeutic gas.

Disclosure of Invention

According to some embodiments of the present disclosure, an apparatus for generating and/or delivering a therapeutic gas, such as Nitric Oxide (NO), is provided.

In one general aspect, a therapeutic gas delivery device may include a therapeutic gas source configured to generate a therapeutic gas. The therapeutic gas delivery device may further include a gas storage portion connected downstream of the therapeutic gas source, the gas storage portion configured to store at least a portion of the therapeutic gas from the therapeutic gas source. The therapeutic gas delivery device may further comprise a gas output connected downstream of the gas storage portion, the gas output configured to output therapeutic gas on demand. In addition, the therapeutic gas delivery device may further comprise a gas replenishment portion coupled to the gas storage portion, the gas replenishment portion being configured to replenish the gas storage portion with a gas. The device may further comprise a pressure control unit connected to the gas storage part for stabilizing the pressure inside the gas storage part. The therapeutic gas delivery device may further comprise a flow control unit coupled to the gas delivery portion for controlling the amount of therapeutic gas delivered through the gas delivery portion.

Embodiments of the therapeutic gas delivery device may include one or more of the following features. The pressure control unit is configured to stabilize the pressure inside the gas storage portion at a preset value greater than 120 cm of water. The gas output is configured to deliver therapeutic gas to the respiratory device, and the pressure control unit is configured to maintain a pressure inside the gas storage that is higher than a pressure in an inspiratory limb of the respiratory device. When the patient downstream of the gas output is in an exhalation phase, or the flow rate of the therapeutic gas output by the gas output to the patient is lower than the flow rate of the therapeutic gas provided by the therapeutic gas source, at least a portion of the therapeutic gas provided by the therapeutic gas source is stored in the gas storage.

When the flow rate of the therapeutic gas outputted from the gas output portion to the patient exceeds the flow rate provided by the therapeutic gas source, the therapeutic gas stored in the gas storage portion is spontaneously outputted to the gas output portion.

The gas supplied by the gas supply part may include air or therapeutic gas. The inlet of the air supplementing part is connected with a power source to ensure the driving force for supplementing air to the air storage part, wherein the power source can comprise a high-pressure air bottle, a central air source of a hospital or an air pump.

The pressure control unit may include a back pressure valve when the air supplementing part is connected to the power source, wherein the back pressure valve is configured to release the air in the air storing part through a pressure release port of the back pressure valve to stabilize the pressure in the air storing part when the pressure in the air storing part exceeds a preset value.

When the power source connected to the air supplementing portion may include a high-pressure air cylinder or an air pump, the pressure control unit may include a combination of a pressure reducing valve configured to stabilize an input pressure from the power source and a back pressure valve.

The pressure control unit may comprise a valve member providing both a pressure reducing function and a back pressure function. The pressure control unit may include a first mass flow controller further coupled to the gas supply portion to control the flow of gas supplied by the gas supply portion to the gas storage portion. A pressure relief gas circuit is configured between the first mass flow controller and the gas storage portion, wherein the pressure relief gas circuit may include a second mass flow controller configured to control a flow rate of gas released from the gas storage portion to stabilize a pressure inside the gas storage portion.

The pressure control unit may comprise a combination of a pressure sensor configured to detect a pressure in the gas storage portion and an electrically operated control valve configured to control the opening in dependence of the detected pressure to adjust the gas flow through the opening. The electrically controlled valve may comprise a solenoid valve or a proportional valve.

The cross-sectional area of the gas reservoir is between 1mm ² and 4cm ² (inclusive). The replenishing portion is further connected to a therapeutic gas source and configured to replenish the therapeutic gas source with a gas. The therapeutic gas source may include an electrochemical instant preparation device for electrochemically generating Nitric Oxide (NO), and the gas replenishing portion is further configured to input a purge gas to the therapeutic gas source for purging the electrode and the NO generated electrochemically, wherein the purge gas may include air or nitrogen.

The therapeutic gas source may include an on-line preparation device for generating NO using an arc method, and the gas supplementing part is configured to input a reactive gas to the therapeutic gas source, wherein an electrode inside a reaction chamber of the therapeutic gas source is used to generate NO by a high-voltage electric shock, and the generated NO is carried out by an excessive portion of the reactive gas.

The reactant gas may include air or an oxygen-nitrogen containing gas. The gas supplementing part is configured to connect the gas storage part and the therapeutic gas source at the same time, and input gas to the gas storage part and the therapeutic gas source by power. The air supplementing part can comprise a first air supplementing part connected with the air storage part and a second air supplementing part connected with the treatment air source, wherein the first air supplementing part and the second air supplementing part are connected with different power sources and respectively convey different gases to the air storage part and the treatment air source.

The first gas supply section is configured to input air into the gas storage section and the second gas supply section is configured to input nitrogen into the therapeutic gas source.

The therapeutic gas delivery device may further include a second flow control unit installed downstream of the therapeutic gas source to control a flow rate of the therapeutic gas outputted from the therapeutic gas source. The therapeutic gas delivery device may further comprise a second flow control device mounted upstream of the therapeutic gas source for controlling the flow rate of the gas entering the therapeutic gas source.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the embodiments of the invention, as claimed.

The accompanying drawings form a part of this specification. The accompanying drawings illustrate several embodiments of the invention and, together with the description, serve to explain the principles of certain disclosed embodiments as recited in the appended claims.

Drawings

Fig. 1 is a schematic view of a therapeutic gas delivery device according to a first embodiment of the present disclosure.

Fig. 2 is a schematic view of a therapeutic gas delivery device according to a second embodiment of the present disclosure.

Fig. 3 is a schematic view of a therapeutic gas delivery device according to a third embodiment of the present disclosure.

Fig. 4 is a schematic view of a therapeutic gas delivery device according to a fourth embodiment of the present disclosure.

Fig. 5 is a schematic view of a therapeutic gas delivery device according to a fifth embodiment of the present disclosure.

Fig. 6 is a schematic diagram of an electrochemical instant preparation device according to some embodiments of the present disclosure.

Fig. 7 is a schematic diagram of an arc process point-of-care manufacturing apparatus according to some embodiments of the present disclosure.

Fig. 8 is a schematic diagram of a Nitric Oxide (NO) supply module in a respiratory device according to a first embodiment of the present disclosure.

Fig. 9 is a schematic view of a NO supply module in a respiratory apparatus according to a second embodiment of the present disclosure.

Fig. 10 is a schematic view of a NO supply module in a respiratory apparatus according to a second embodiment of the present disclosure.

Fig. 11 is a schematic view of a NO supply module in a respiratory apparatus according to a third embodiment of the present disclosure.

Fig. 12 is a schematic view of a NO supply module in a breathing apparatus according to a fourth embodiment of the disclosure.

Fig. 13 is a schematic view of a NO supply module in a respiratory apparatus according to a fifth embodiment of the present disclosure.

Fig. 14 is a schematic view of an NO supply module in a respiratory apparatus according to a sixth embodiment of the present disclosure.

Fig. 15 is a schematic view of a NO supply module in a respiratory apparatus according to a seventh embodiment of the present disclosure.

Fig. 16 is a schematic view of an NO supply module mounted in a respiratory device by a mounting slot, according to some embodiments of the present disclosure.

Fig. 17 is a schematic diagram of an NO production and delivery system according to some embodiments of the present disclosure.

It should be recognized that some or all of the figures are schematic representations for purposes of illustration.

Detailed Description

The disclosed embodiments will now be described in detail. Unless defined otherwise, technical or scientific terms have the meaning commonly understood by one of ordinary skill in the art. The embodiments disclosed are described in sufficient detail to enable those skilled in the art to practice the embodiments disclosed. It is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the disclosed embodiments. Accordingly, the materials, methods, and examples are illustrative only and not intended to be necessarily limiting.

Fig. 1 is a schematic view of a therapeutic gas delivery device according to a first embodiment of the present disclosure. As shown in the figure, the therapeutic gas delivery device includes a therapeutic gas source 1, a gas storage section 2, a gas output section 3, a gas supplementing section 4, a pressure control unit 5, and a flow control unit 6.

The therapeutic gas source 1 is used for the immediate generation of therapeutic gases such as NO, CO, H ₂S、H₂, etc.

The gas storage part 2 is connected downstream of the therapeutic gas source 1 for storing the therapeutic gas supplied from the therapeutic gas source 1.

The gas outlet 3 is connected downstream of the therapeutic gas source 1 for delivering therapeutic gas to the patient.

The gas replenishing portion 4 is connected to the gas storage portion 2, and can replenish the gas to the gas storage portion 2 through this portion.

The pressure control unit 5 is connected to the gas storage section 2 for stabilizing the pressure in the gas storage section 2 at a preset value. In some embodiments, the preset value is generally greater than 120 centimeters of water. By stabilizing the pressure inside the gas storage 2 at a preset value, it is ensured that the pressure inside the gas storage 2 is higher than the pressure of the ventilator's inhalation branch, so that the therapeutic gas inside the gas storage 2 is spontaneously output to the ventilator circuit. The higher the preset pressure value, the greater the maximum flow rate that can be achieved by the therapeutic gas delivery device, thereby improving the breath following effect. However, an increase in pressure value also increases the demands on the reliability of the device.

A flow control unit 6 is located on or upstream of the gas output 3 and is configured to control the amount or flow rate of therapeutic gas delivered to the patient.

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

When the amount of gas delivered to the patient side by the gas output section 3 exceeds the amount of gas supplied from the therapeutic gas source 1, the therapeutic gas stored in the gas storage section 2 spontaneously migrates to the gas output section 3. The gas supplied from the gas supply portion 4 to the gas storage portion 2 may be air, therapeutic gas, or the like. The inlet of the gas replenishing portion 4 may be connected to a power source, providing sufficient driving force to replenish the gas to the gas storage portion 2. For example, the power source may be a high pressure gas cylinder, a central gas source for a hospital, or a gas pump.

There are various implementations of the pressure control unit 5. As in the first embodiment shown in fig. 1, the pressure control unit 5 may be a back pressure valve when the air supplementing portion 4 is connected to a stably controllable power source. When new therapeutic gas enters the gas storage part 2, and the gas pressure in the gas storage part 2 exceeds a preset value, the gas is discharged from the gas storage part 2 through the pressure relief opening of the back pressure valve, so that the pressure in the gas storage part 2 is kept stable.

As in the second embodiment shown in fig. 2, when the power source connected to the air supply portion 4 is a high-pressure air cylinder or an air pump, the pressure control unit 5 may include a pressure reducing valve 5b and a back pressure valve 5a. The pressure reducing valve 5b may reduce and stabilize the pressure of the power source input. When the pressure of the gas in the gas storage part 2 exceeds a preset value, the gas is discharged from the gas storage part 2 through the pressure relief port of the back pressure valve 5a to keep the pressure in the gas storage part 2 stable.

As in the third embodiment shown in fig. 3, some valve devices/assemblies may have both pressure relief and back pressure functions. Therefore, such a valve member 5c can be attached to the gas storage portion 2, and the same effects as those of the pressure reducing valve 5b and the back pressure valve 5a in the second embodiment can be achieved.

In addition to the mechanical valve forms described above, the pressure control unit may also take the form of a Mass Flow Controller (MFC) or the like. For example, a first mass flow controller may be provided on the gas replenishing portion 4 to control the mass flow of the gas replenished to the gas storage portion 2. A pressure relief air passage may be provided between the first mass flow controller and the gas storage portion 2, and a second mass flow controller may be disposed on the pressure relief air passage to control the mass flow of the exhaust gas, thereby achieving the effect of maintaining a stable pressure in the gas storage portion 2.

In some embodiments, the pressure control unit 5 may 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 for detecting the pressure of the gas storage part 2, and the electric control valve adjusts the opening degree according to the detected pressure value to control the size of the passing gas flow. For example, if a lower pressure is detected, the airflow through may decrease. The pressure sensor may be provided downstream of the gas storage section 2, but may be delayed in detecting a pressure change due to the flow rate adjustment performed by the electric control valve, which is disadvantageous for pressure control.

In some embodiments, the pressure control unit 5 may be mounted on the air supply portion 4 or on the gas storage portion 2. It is generally not advisable to install the pressure control unit 5 in the vicinity of the gas outlet 3, because when an excess of therapeutic gas is introduced into the gas storage 2, the pressure control unit 5 will expel some of the old gas from the gas storage 2, making room for the newly introduced therapeutic gas. If the pressure control unit 5 is located too close to the gas outlet 3, the actual volume of the gas reservoir 2 available for storing therapeutic gas is reduced. In order to maximize the available volume of the gas storage portion 2 and reduce the size of the gas storage portion 2, it is preferable to install the pressure control unit 5 on the gas supplementing portion 4.

In some embodiments, the cross-sectional area S of the gas storage portion 2 is 1mm ² to 4cm ² (including 4cm ²). The sectional area S near or below the lower limit causes an increase in air resistance, and it is difficult to achieve the effect of rapid air delivery. If the cross-sectional area S approaches or exceeds the upper limit, diffusion and mixing of the therapeutic gas and the supplemental gas at the interface may be exacerbated, affecting the concentration of the output therapeutic gas, reducing the utilization of the generated therapeutic gas.

As in the fourth embodiment shown in fig. 4, the air supply portion 4 may also be connected to the therapeutic gas source 1 to supply air to the therapeutic gas source 1.

In some embodiments, when the therapeutic gas source 1 is an electrochemical instant preparation device for electrochemical generation of NO, the gas replenishing portion 4 may be fed with a purge gas (air, nitrogen, etc.) for purging the electrodes and the NO gas generated by the electrochemical.

Fig. 6 shows an example of an electrochemical instant preparation device. As shown, the exemplary electrochemical instant preparation device includes a reaction chamber 11 having a gas zone and a liquid zone. The liquid zone is for containing reaction medium 12 and the gas zone is for containing product gas including NO. The 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 to the electrode 13. Purge gas inlet 14 is used to introduce a purge gas, which may be air, nitrogen, or the like, into reaction medium 12 to sweep out NO gas generated in reaction medium 12. In addition, reaction medium 12 may also include a buffer solution, a nitrite ion source, and a catalyst, wherein the catalyst includes a metal ligand complex and the nitrite ion source includes one or more nitrites. For example, the composition of the reaction medium 12 can be referred to the disclosure in chinese patent publication No. CN114318357a published at 4/12 of 2022, which discloses an electrolyte for achieving high concentration output of NO, and a corresponding electrolytic cell and electrolytic method. The contents of chinese patent publication No. CN114318357a are incorporated herein by reference. One example of an electrochemical instant production device for generating NO may be referred to the disclosure of chinese patent publication No. CN110831640a, published under 21, 2/2020, which discloses a nitric oxide generating system for a gas delivery device. The contents of chinese patent publication No. CN110831640a are also incorporated herein by reference.

In some embodiments, when the therapeutic gas source 1 is an on-line production device that generates NO using an arc process, the gas replenishing portion 4 may be supplied with a reactive gas (air, oxygen-nitrogen-containing gas, or the like). Fig. 7 illustrates an instant preparation apparatus using an arc method. As shown in fig. 7, the instant preparation apparatus using the 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 the excessive reaction gas. The instant preparation apparatus may further comprise a reaction gas inlet 23 for introducing a reaction gas into the reaction chamber 21. The reaction gas may be air. The electrode 22 is configured to generate a product gas from the reactant gas using a high voltage circuit, the product gas containing a desired amount of NO.

Referring back to fig. 4, the gas supply part 4 may be connected to both the gas storage part 2 and the therapeutic gas source 1, and the same gas (e.g., air) is supplied to the gas storage part 2 and the therapeutic gas source 1 by the power source. Alternatively, two air supplementing parts 4 may be provided, each air supplementing part 4 is connected to the air storage part 2 and the therapeutic gas source 1, and the two air supplementing parts 4 are connected to different power sources, so as to deliver different gases, for example, air is input to the air storage part 2 and nitrogen is input to the therapeutic gas source 1.

In addition, a flow control device 7 may be installed downstream of the therapeutic gas source 1 to control the flow rate of the therapeutic gas outputted from the therapeutic gas source 1.

The flow control unit 7 may also be installed upstream of the therapeutic gas source 1 as in the fifth embodiment shown in fig. 5 to control the flow rate of the gas into the therapeutic gas source 1.

The therapeutic gas delivery device is shown in figures 1-7. There are many differences from existing nitric oxide generation and delivery systems and methods. For example, chinese patent publication No. CN110573454B describes a system and method for generating NO (e.g., paragraph 0227 of the specification and fig. 19-25). The structure mentioned in CN110573454B includes a buffer tank, a piston, a diaphragm and a diaphragm driver, forming a temporary reservoir through which NO gas is output. The solution disclosed in CN110573454B requires a volume of buffer tank to store NO gas, which places a limit on the miniaturization of the device. Furthermore, the output of nitric oxide gas is dependent on mechanical structures such as pistons and diaphragms, which may generate friction and wear during operation. The action of the piston and diaphragm need to be controlled by signal transmission, which presents challenges for the immediacy and reliability of the system operation.

The above limitations of CN110573454B are addressed by the technical solutions described in the present disclosure. For example, the power source that drives the gas storage portion 2 to output NO gas is a steady pressure in the gas storage portion 2. The medium for driving the output of the NO gas is the make-up gas charged into the gas reservoir 2 through the make-up gas portion 4 (the interface between the make-up gas and the NO gas in the gas reservoir 2 can be regarded as approximately a piston). NO signal transmission or other forms of control are required during the NO gas output in the gas storage section 2. The output may be achieved instantaneously by pressure dependence. Furthermore, the use of make-up gas as a medium during the output process eliminates friction and wear.

In view of the above, the therapeutic gas delivery device described herein has at least the following technical advantages. First, it enables a follow-up breathing gas output with a sufficiently small device size. The miniaturization and light-weight design greatly reduces the limit brought by the treatment device, and is convenient for integrating with other treatment devices.

In addition, due to the small size of the gas reservoir 2, NO gas that accumulates over time is minimal, which in turn minimizes NO ₂ gas generated within the gas reservoir 2.

Furthermore, the therapeutic gas delivery device described herein eliminates the need for complex electromagnetic elements or signal transmission for control coordination, eliminating the presence of wearing parts. This aspect helps to improve the high reliability and instantaneity of the device.

Another significant advantage is the efficient use of the therapeutic gas produced by the device. The rise time of the device in the present disclosure is shorter when outputting therapeutic gas, compared to the background art and the "air tank" technology mentioned in chinese patent publication No. CN 110573454B. In a system using a gas storage tank, the nitrogen oxide gas needs to be mixed with air in the initial stage until uniform mixing is achieved, and then the concentration of the output nitrogen oxide cannot be stabilized. In contrast, the apparatus described herein uses a smaller diameter and volume gas reservoir 2 based system. This design allows for a rapid evacuation of the raw gas in the gas reservoir 2 upon introduction of NO gas, thereby rapidly adjusting to the desired NO concentration in one to two breathing cycles. This results in a shorter rise period of concentration and a faster response speed, highlighting the efficiency and response capability of the therapeutic gas delivery device.

The therapeutic gas delivery device depicted in fig. 1-7 may be integrated into a respiratory device or system as a Nitric Oxide (NO) delivery module. The following description illustrates one breathing apparatus example (fig. 8-16) and one system example (fig. 17).

Breathing apparatus with Nitric Oxide (NO) supply module

As described in the background section, the output of breath-following therapeutic gas requires that a certain flow rate of therapeutic gas be rapidly injected according to the breathing rate, flow rate and pressure of the ventilator, anesthesia machine, etc. In some cases, the flow may need to reach above 120L/min in a short time.

For respiratory follow-up delivery, a gas storage vessel with a certain pressure and volume may be arranged upstream of the therapeutic gas inlet conduit. The gas storage container stores the therapeutic gas at a proper time, and releases the stored therapeutic gas when the suction flow rate is rapidly increased in a short time, so as to make up for the shortages of instantaneous preparation and transmission flow rate of the therapeutic gas device.

Existing NO treatment devices that perform the breath-following delivery function typically have a large volume and weight. When used with breathing apparatuses such as ventilators, nitric oxide therapy apparatuses require their own dedicated space. This is very disadvantageous in environments where space such as an intensive care unit is very limited. The volume and weight limitations of existing NO treatment devices, when used alone, also make them difficult to apply to applications where portability is required, such as home use or outdoor environments.

In order to solve the technical difficulties of the prior art solutions, the therapeutic gas delivery device described in fig. 1-7 may be used as a Nitric Oxide (NO) supply module in a breathing apparatus.

Fig. 8 shows a first embodiment of a nitric oxide delivery module. As shown, the NO supply module may include a housing 1000. The housing 1000 may include a reaction chamber 81 therein, the reaction chamber 81 having an inlet 810 and an outlet 811. The reaction chamber 81 may further include an electrode 812. Inlet 810 allows a flow of reactant gas (typically air) to enter and electrode 812 causes the flow of reactant gas to pass through reaction chamber 81 to generate a nitric oxide product gas, and outlet 811 releases a flow of gas containing the product gas.

The housing 1000 may further include a gas storage portion 82 located downstream of the outlet 811. The gas storage 82 is configured to store at least a portion of the product gas from the outlet 811 at a particular time. The housing 1000 may further include a gas delivery portion 83 located downstream of the outlet 811. The gas delivery portion 83 is configured to direct a gas stream containing the product gas out of the housing 1000.

The housing 1000 may further include a power source 84 coupled to the gas storage portion 82 to maintain a steady pressure of the gas within the gas storage portion 82.

When the flow rate output from the gas delivery portion 83 to the outside of the housing 1000 is smaller than the flow rate supplied from the outlet 811 to the gas delivery portion 83, the surplus gas is introduced into the gas storage portion 82 to store at least part of the surplus gas. When the flow rate output from the gas delivery portion 83 to the outside of the housing 1000 is required to exceed the flow rate supplied to the gas delivery portion 83 from the outlet 811, the gas stored in the gas storage portion 82 is introduced into the gas delivery portion 83.

In addition, the housing 1000 may be designed as a removable component that is integrated with the respiratory device 2000.

The housing 1000 may be provided with a gas delivery interface 1001 which is connected to the gas delivery section 83. The respiratory device 2000 may have a port that is compatible with the gas delivery port 1001 and is connected to the inspiratory limb 2001 of the respiratory device 2000.

In a first embodiment of the NO supply module shown in fig. 8, the housing 1000 is provided with an air inlet interface 1002. The respiratory device 2000 has an interface that is compatible with the connection to the air intake interface 1002, which interfaces with the internal airway of the respiratory device 2000. An air inlet 810 of the reaction chamber 81 is connected to the air inlet interface 1002, and a reaction air flow is supplied to the reaction chamber 81 through an internal air passage of the breathing apparatus 2000. The gas storage 82 is also connected to an air inlet interface 1002 that receives gas through the internal airway of the respiratory device 2000, wherein the air inlet interface 1002 acts as a power source 84.

In addition, the power source 84 in fig. 8 further includes a pressure control device 85 for maintaining the stability of the gas pressure inside the gas storage portion 82. The pressure control device 85 may be a pressure reducing valve with a pressure relief function (effectively integrating functions of a back pressure valve and a pressure reducing valve), a combination of the pressure reducing valve and the back pressure valve, as shown in fig. 4 of chinese patent publication No. CN2023106604381, or a set of mass flow controllers that are mutually matched, as shown in fig. 9 of chinese patent publication No. CN 2023106604381.

Fig. 9 is a schematic view of a NO supply module in a respiratory apparatus according to a second embodiment of the present disclosure. In the second embodiment shown in fig. 9, an air intake interface 1002 is also provided on the housing 1000. The breathing apparatus (not shown in fig. 9, see 2000 in fig. 8) has a mouthpiece that is compatible with the connection to the inlet mouthpiece 1002, which is connected to the internal airway of the breathing apparatus. The inlet port 810 of the reaction chamber 81 is connected to the inlet port interface 1002, and the inlet port 1002 provides a flow of reactant gas to the reaction chamber 81 through the internal airway of the respiratory device. The power source 84 includes an air pump 840 located within the housing 1000. The air pump 840 is connected to the gas storage 82, and supplies air to the gas storage 82. In addition, a pressure control device 85 is included, which can use the same pressure control device as the first embodiment (as shown in fig. 8).

Fig. 10 is a schematic view of a NO supply module in a respiratory apparatus according to a third embodiment of the present disclosure. In the third embodiment shown in fig. 10, an air intake port 1002 is provided on the housing 1000. The breathing apparatus (not shown in fig. 9, see 2000 in fig. 8) has an interface that mates with and connects to the air intake interface 1002, which interfaces with the internal airway of the breathing apparatus. The inlet port 810 of the reaction chamber 81 is connected to the inlet port 1002, and the inlet port 1002 provides a flow of reaction gas to the reaction chamber 81 through the internal airway of the respiratory device.

In addition, the housing 1000 in fig. 10 also has an air supply interface 1003. The breathing apparatus is provided with an interface that mates with and connects to the air supply interface 1003, which interfaces with the internal airway of the breathing apparatus. The gas storage 82 is connected to a gas supply port 1003, and the gas supply port 1003 supplies gas to the gas storage 82 through an internal airway of the breathing apparatus, and serves as a power source 84. Further, the pressure control device 85 in the first and second embodiments may be also included.

Fig. 11 is a schematic view of a NO supply module in a breathing apparatus according to a fourth embodiment of the present disclosure. In the fourth embodiment shown in fig. 11, the housing 1000 does not have an air intake interface (e.g., 1002 in fig. 8-10) or an air supply interface (e.g., 1003 in fig. 8-10). Within the housing 1000, there is a first gas pump 8100, with an inlet 810 of the reaction chamber 81 being connected to the first gas pump 8100, the first gas pump 8100 providing a flow of reaction gas to the reaction chamber 81. The power source 84 includes a second gas pump 840 located within the housing 1000. The second gas pump 840 is connected to the gas storage 82, and is configured to supply gas to the gas storage 82. Further, the pressure control device 85 in the foregoing embodiment is also included.

Fig. 12 is a schematic view of a NO supply module in a respiratory apparatus according to a fifth embodiment of the present disclosure. In the fifth embodiment shown in fig. 12, the housing 1000 does not have an air intake interface (e.g., 1002 in fig. 8-10) or an air supply interface (e.g., 1003 in fig. 8-10). Inside the housing 1000 is a second gas pump 8100, and an inlet 810 of the reaction chamber 81 is connected to the second gas pump 8100, and the second gas pump 8100 supplies a reaction gas flow to the reaction chamber 81. The gas storage portion 82 is also connected to a second gas pump 8100, and the second gas pump 8100 supplies gas to the gas storage portion 82, thereby functioning as a power source 84. Further, the pressure control device 85 in the foregoing embodiment is also included.

Fig. 13 is a schematic view of a NO supply module in a respiratory apparatus according to a sixth embodiment of the present disclosure. In the sixth embodiment shown in fig. 13, the housing 1000 does not have the air intake interface 1002. Inside the housing 1000 is an air pump 8100, and an inlet 810 of the reaction chamber 81 is connected to the air pump 8100, and the air pump 8100 supplies a reaction air flow to the reaction chamber 81. The housing 1000 is provided with an air supply port 1003. The interface of the respiratory device (not shown in fig. 9, see 2000 in fig. 8) mates with and connects to the air supply interface 1003, which interfaces with the internal airway of the respiratory device. The gas storage 82 is connected to a gas supply interface 1003, and the gas supply interface 1003 supplies gas to the gas storage 82 through an internal airway of the breathing apparatus, thereby serving as a power source 84. Further, the pressure control device 85 in the foregoing embodiment is also included.

In the embodiments described in the present disclosure, the gas storage portion 82 may include at least one gas storage channel 820. The gas storage channel 820 may have a cross-sectional area small enough to minimize the diffusion phenomenon between gases (i.e., to reduce the diffusion of the interface between the nitric oxide gas stored in the gas storage channel 820 and the air input by the power source), and the cross-sectional area S of the gas storage channel 820 may be configured within the range of 1mm ²≤S≤4cm².

Other ways of implementing the power source 84 may be provided in addition to those described in the previous embodiments. For example, the power source 84 may take the form of a piston cylinder in which the gas reservoir 82 is integrated. The piston rod is driven to change the volume of the space of the gas storage portion 82, thereby realizing control of the pressure of the gas storage portion 82. Compared to the other forms mentioned in the previous embodiments, this piston cylinder structure has some disadvantages, namely 1) the volume effect-the internal space of the module housing is limited, the form of the piston cylinder may cause an increase in the overall volume of the module, 2) the reliability-the piston rod of the piston cylinder needs to frequently repeat the driving action, which poses a challenge to the reliability, 3) the delay-the timing of driving the piston rod needs to be controlled by signal feedback, which easily causes delay, resulting in mismatching of the internal pressure of the gas storage 82 with the required pressure, affecting the output accuracy of nitric oxide, 4) noise, and 5) power consumption.

As another example, power source 84 may take the form of an air bag. In this case, the gas storage unit 82 is a retractable gas bag structure, and a force for restoring the deformation of the gas bag structure is used as a power source. This method also has certain drawbacks, such as fatigue and wear caused by repeated deformation of the air bag, resulting in a limited service life.

In the embodiment of the NO supply module illustrated in the present disclosure, a first flow control device 86 (as in the example shown in fig. 8, but applicable to all described embodiments) is installed on the upstream pipe connected to the inlet 810 of the reaction chamber 81 to control the flow of the reaction gas into the reaction chamber 81. In certain embodiments, the first flow control device 86 may be a Mass Flow Controller (MFC).

In addition, a second flow control device 87 (shown in fig. 8, but applicable to all of the embodiments) may be mounted on the gas delivery portion 83 for controlling the flow rate of the effluent gas stream. The second flow control device 87 may also be a Mass Flow Controller (MFC).

Taking the embodiment shown in fig. 8 as an example (applicable to all of the described embodiments), a filtering device 88 may be installed on the gas delivery portion 83 to filter NO ₂ in the product gas. The filter 88 is detachably connected to the gas transmission portion 83. The filter 88 has an inlet and an outlet, which are connected to the gas delivery portion 83, respectively.

Taking the embodiment shown in fig. 8 as an example (applicable to all of the described embodiments), the filter device 88 is located outside of the housing 1000. For example, the housing 1000 is provided with ports for inserting the inlet and outlet of the filter device 88, and the internal port of the housing 1000 is connected to the gas transmission portion 83. Alternatively, the filter 88 may be mounted inside the housing 1000 adjacent to the wall of the housing 1000, with a removable operating window being provided in the housing 1000 at the corresponding location of the filter 88. The filter 88 is a consumable product whose filter material (e.g., quicklime, etc.) may need to be replaced periodically over time. Placement of the filter 88 on the exterior of the housing 1000 or on a wall adjacent the housing 1000 facilitates replacement. The filter means 88 is preferably mounted upstream of the second flow control means 87. The upstream mounting of the filter device 88 helps to ensure the effectiveness of the breath-following because the filter device has a filter chamber filled with filter material. If the filtering means 88 is installed downstream of the second flow control means 87, the flow rate and timeliness of the therapeutic gas output through the second flow control means 87 and through the filtering chamber may be affected, thereby affecting the effect of the breath following.

Taking the embodiment shown in fig. 8 as an example (applicable to all the described embodiments), a detection branch 89 is installed on the gas transmission portion 83, and one end thereof is connected to the gas transmission portion 83 and the other end thereof is opened to the environment. The detection branch 89 is used for measuring the nitric oxide concentration in the gas delivery portion 83. In addition, the detecting branch 89 further includes a gas barrier 890 and a nitric oxide sensor 891, which are arranged in order from the near gas transmitting part 83 to the far gas transmitting part 83. The provision of the air barrier prevents a large amount of air from escaping into the environment through the detection branch 89, allowing only a small amount of air to pass through the detection branch 89 to the sensor.

In some embodiments, the detection branch 89 in the example shown in fig. 8 is located upstream of the second flow control device 87 and downstream of the filtering device 88. Ideally, the detection branch 89 is as close as possible upstream of the second flow control device 87 to ensure that the detected NO concentration is as close as possible to the actual output concentration. If the detection branch 89 is placed downstream of the second flow control device 87, it will be difficult for the therapeutic gas to enter the detection branch 89, possibly resulting in undetectable concentrations of therapeutic gas. Placing the detection branch 89 upstream of the filtering means 88 will result in a decrease of the actual output NO concentration.

In some embodiments, the NO supply module shown in fig. 8-13 may further comprise a sample detection unit 3000 comprising a detection gas passage 3100 located inside the housing 1000 and a sampling gas passage 3200 located outside the housing 1000. The detection gas path 3100 is connected to the sampling gas path 3200.

Taking the embodiment shown in fig. 8 as an example (applicable to all of the embodiments), one end of the sampling gas path 3200 is connected to the inspiratory limb 2001 of the respiratory device 2000, and the other end is connected to the detection gas path 3100 within the housing 1000 via a water trap 3201. The water trap 3201 is mainly used for filtering moisture in the sampled gas so as to prevent damage to downstream sensors or influence on detection results. The water trap 3201 needs to be detached periodically, and is located outside the housing 1000, and a mounting seat for mounting the water trap 3201 is arranged on the housing 1000.

In some embodiments, the detection gas channel 3100 is connected at one end to the water trap 3201 and is open at the other end to the environment. The detection gas passage 3100 is equipped with a sampling gas pump 3101 and a sensor unit 3102. The sampling gas pump 3101 provides sampling power and the sensor unit 3102 may include a nitric oxide sensor, a nitrogen dioxide sensor, an oxygen sensor, etc. for detecting NO, NO ₂、O₂, etc. in the gas to be inhaled by the patient.

As shown in fig. 14 and 15, in the NO supply module, the sampling detection unit 3000 is optional, and the embodiment shown in fig. 8 includes the sampling detection unit 3000. In the embodiment shown in fig. 14 and 15, the sampling detection unit 3000 is not included. In some embodiments, the sampling detection unit (3000 shown in fig. 8) may be a stand-alone module that is assembled with the respiratory device (2000 shown in fig. 8).

In some embodiments, a fan (see 4000 in FIG. 8) may be provided within the housing 1000 in FIGS. 8-13. Taking the embodiment shown in fig. 8 as an example (applicable to all of the described embodiments), a fan 4000 is provided on the inner wall of the housing 1000, and a vent hole is provided in the housing 1000 at the position of the fan 4000. A fan 4000 may also be placed outside the housing 1000, the main function of which is to promote cooling and ventilation.

As an example, the end of the detection branch 89 connected to the environment is connected to the fan 4000, and thus to the outside environment of the housing 1000. Also, the end of the sensing gas channel 3100 of the sampling sensing unit 3000 connected to the environment is also connected to the fan 4000, thereby being connected to the external environment of the housing 1000. The gas escaping into the environment through the detection branch 89 may comprise the product gas nitric oxide, which is easily oxidized to toxic nitrogen dioxide. If it accumulates in the housing 1000, it creates a safety hazard and is therefore connected to the fan 4000 and can be discharged to the outside environment as soon as possible. Similarly, a certain amount of nitric oxide and nitrogen dioxide in the sensing gas channel 3100 of the sampling sensing unit 3000 is discharged to the external environment as soon as possible by the fan 4000. In addition, the fan 4000 disperses these gases before they are exhausted, preventing the accumulation of NO, NO ₂, and other exhaust gases. In certain embodiments, the fan 4000 is optional in the NO supply module (see the embodiment of fig. 14 that does not include a fan).

In some embodiments, when the pressure control device 85 is a pressure relief valve with a pressure relief function, a pressure relief port thereof may also be connected to the blower 4000 through a pipe. The overflow port may also be directly connected to the environment. Alternatively, the overflow may be connected by piping to the inlet of the filter device 88.

Fig. 16 is a schematic illustration of a portable NO supply that may be mounted to a respiratory apparatus 2000 via a mounting slot 2002 according to some embodiments of the present disclosure. Wherein the housing 1000 is designed to be portable. The mounting slot 2002 is designed for mounting the portable NO supply to the breathing apparatus 2000.

Nitric Oxide (NO) preparation and transmission system

Fig. 17 illustrates a schematic diagram of a nitric oxide preparation and delivery system, according to some embodiments of the present disclosure. As shown, the nitric oxide production and delivery system may comprise an inlet unit for supplying gas to the system and a reaction chamber 171 located downstream of the inlet unit. The reaction chamber may include an inlet 1710, an outlet 1711, and an electrode 1712. The gas inlet 1710 is connected to a gas inlet unit to receive a flow of reactant gas (e.g., air) and the electrode 1712 passes the flow of reactant gas through the reaction chamber 171 to generate nitric oxide product gas. Outlet 1711 releases a gas stream containing product gas.

As shown in fig. 17, the NO production and delivery system may further comprise a delivery unit for directing the product gas containing gas stream out of the system, the delivery unit comprising a gas storage portion 172, a gas delivery portion 173, a make-up portion 174 and a pressure control unit 175. As shown in fig. 17, a gas storage 172 is located downstream of the outlet 1711 for storing at least a portion of the product gas from the outlet 1711 at a particular time. A gas delivery 173 is also located downstream of the outlet 1711 for directing a gas stream containing product gas out of the system. One end of the gas replenishing portion 174 is connected to the gas inlet unit, and the other end is connected to the gas storage portion 172, for replenishing the gas to the gas storage portion 172. The pressure control unit 175 is connected to the gas storage portion 172 for maintaining the pressure in the gas storage portion 172 at a preset value. One end of the air supply portion 174 may also be connected to an independent air intake unit to perform the function of supplying air.

In some embodiments, the air intake unit may include one or more components. For example, the air intake unit may include an air intake filter for filtering particulates, volatile organic compounds, etc. in the air to prevent damage to internal components of the device (e.g., an air pump) or inhalation by the patient. Downstream of the intake filter, the intake unit may further comprise an air pump (which may be a diaphragm pump or other type of booster pump). The pump draws air from the environment into the apparatus, providing a source of air for the generation of NO in the reaction chamber 171, as well as a source of pressurized air for the system.

Downstream of the air pump, the air intake unit may further comprise an air container, the purpose of which is to reduce the fluctuation of the pulsating air flow generated by the air pump, to stabilize the air flow and the pressure generated by the air intake unit.

While the air pump provides a pressurized air source, it may also produce water. If water enters the system, it may affect the generation of NO therapeutic gas in the arc chamber 171 and may affect the absorption of NO ₂ by the system filter. To solve this problem, an air dehumidifying apparatus may be added. The dehumidifying device may be installed upstream of the air pump, but water may be generated again after passing through the air pump. The dehumidifying device may be arranged downstream of the gas container, but liquid water may already be formed downstream, which requires a high cost for the liquid water to be treated. Therefore, the dehumidifying means is preferably located between the air pump and the air container to rapidly reduce the humidity of the compressed air source. Such dehumidification may be a Nafion tube or other method of filtering water or water vapor.

In some embodiments, the air intake unit may further include a back pressure valve to prevent bursting of the conduit when the air intake unit is at an excessive pressure, and a pressure sensor may be added to detect the pressure of the air intake unit. If the pressure is too high, the pumping may be stopped or reduced.

In some embodiments, when the flow rate of the gas delivery portion 173 to the outside of the system is smaller than the flow rate provided by the outlet 1711 to the gas delivery portion 173, the surplus gas enters the gas storage portion 172, in which at least a portion of the surplus gas is stored. Conversely, when the flow rate required to be output from the gas delivery unit 173 to the outside of the system exceeds the flow rate provided from the outlet 1711 to the gas delivery unit 173, the gas stored in the gas storage unit 172 is guided to the gas delivery unit 173.

In addition, 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), a combination of the pressure reducing valve and the back pressure valve (as shown in fig. 4 of chinese patent CN 2023106604381), or a set of mass flow controllers (as shown in fig. 9 of chinese patent CN 2023106604381) that are mutually matched.

In some embodiments, gas storage portion 172 includes at least one gas storage channel 1720. The gas storage channels 1720 have a cross-sectional area that is small enough to minimize dispersion between gases (i.e., to minimize dispersion at the interface where nitric oxide gas stored in the gas storage channels 1720 meets air input from the power source). The cross-sectional area of gas storage channel 1720 is less than 20 square centimeters, preferably less than 4 square centimeters, and more preferably less than 1 square centimeter. In addition, in order to fully utilize the gas storage space of the gas storage part 172 and minimize the overall space occupied thereby, a port for inputting/outputting nitric oxide gas in the gas storage part 172 is located at one end of the gas storage channel 1720, and a port for connecting the power source 174 is located at the other end of the gas storage channel 1720.

In some embodiments, the gas inlet unit is connected to the inlet 1710 of the reaction chamber 171 by a conduit equipped with a first flow control device 176, the first flow control device 176 being used to regulate the flow of reactant gas into the reaction chamber 171. The first flow control device 176 may also be disposed downstream of the outlet 1711 of the reaction chamber 171. The first flow control device 176 may be a Mass Flow Controller (MFC).

In some embodiments, the NO production and delivery system may further comprise a second flow control device 177 located on the gas delivery section 3 for regulating the flow rate of the effluent gas stream. The second flow control device 177 may also be a Mass Flow Controller (MFC).

In some embodiments, the NO production and delivery system may further comprise a filtering device 178 disposed on the gas delivery portion 173 for filtering nitrogen dioxide in the product gas. The filtering device 178 may be detachably connected to the gas transmission part 173. The filter device 178 may include an inlet and an outlet, each of which is connected to the gas delivery portion 173. In addition, the delivery system may include a detection branch 179 located on the gas delivery portion 173. One end of the detection branch 179 is connected to the gas transmission unit 173, and the other end is open to the environment, so that the nitric oxide concentration in the gas transmission unit 173 can be measured. The detection branch 179 may comprise a gas block 1790 and a nitric oxide sensor 1791, arranged in sequence from the gas delivery portion 173, from near to far. The air lock is intended 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 reach the sensor through the detection branch 179.

In certain embodiments, the NO preparation and delivery system in fig. 17 may further comprise a sample detection unit 3000, which may comprise a detection gas channel 3100 and a sampling gas channel 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 inspiratory branch 2001 of the respiratory apparatus 2000, and the other end is connected to the detection gas path 3100 via a water trap 3201. The water trap 3201 functions to filter moisture in the sampled gas to prevent damage to downstream sensors or to affect detection results.

In some embodiments, the detection gas channel 3100 is connected at one end to the water trap 3201 and at the other end to the environment. The detection gas passage 3100 is provided with a sampling gas pump 3101 and a sensor device 3102. The sampling air pump 3101 provides power for sampling, and the sensor unit 3102 may include a nitric oxide sensor, a nitrogen dioxide sensor, an oxygen sensor, etc. for detecting NO, NO ₂、O₂, etc. in the gas to be inhaled by the patient.

In certain embodiments, the filter device 178 of fig. 17 may house multiple independent filter chambers to achieve different filtering functions. For example, a filter chamber is provided with a calcium oxide filter, which is connected to the gas delivery part 173 for removing nitrogen dioxide from the gas. The other filter chamber is provided with a potassium permanganate filter for removing waste gas, and the outlet of the filter chamber is connected with the environment.

When the pressure control unit 175 is a relief valve with a relief function, its relief port may also be connected by piping to the chamber of the filter device 178 for removing exhaust gases. This arrangement prevents the untreated gas from being released directly into the environment as the product gas is discharged from the overflow through the filter device 178.

In some embodiments, a shut-off valve is installed upstream of the filter device 178 on the gas delivery portion 173. When the service life of the filter device 178 expires, the system does not need to be shut down for replacement. The filter device 178 can be directly removed and replaced, and when the filter device 178 is removed, the stop valve is immediately closed so as to keep the pressure inside the equipment stable. When a new filter 178 is reinserted, the shut-off valve is opened by the filter 178 to reconnect the gas delivery portion 173 and the filter 178, allowing the NO therapeutic gas to be normally output. The shut-off valve may also be a solenoid valve.

In some embodiments, the NO production and delivery system of fig. 17 may further comprise a pressure relief device. The pressure relief device may comprise a pressure relief conduit. One end of the pipe may be connected between the gas storage portion 172 and the pressure control unit 175, or between the gas storage portion 172 and the shut-off valve, or between the filtering device 178 and the flow control device 176. For example, a solenoid valve may be mounted to the pressure relief line. When the equipment stops outputting NO, the electromagnetic valve is opened to rapidly discharge the NO out of the system, so that the NO is prevented from being oxidized into NO ₂ due to excessively long stay time in the system. This also helps to balance the internal and external pressures of the system and extend the service life of the device. Another method is to open the solenoid valve after stopping the NO output and simultaneously stop the arc, and exhaust the NO gas in the system with the air in the intake unit. When NO output is stopped, the gas channels within the system contain air. The other end of the pressure relief conduit may be connected to a chamber of a filter device 178 for cleaning exhaust gases.

In summary, the NO production and transport system in fig. 17 has at least the following technical advantages compared to the prior art solutions:

1) The internal integrated air source is independent of an external air source, so that the equipment has various use scenes, and is convenient to use under the conditions of equipment connection, transportation or transfer;

2) The internal integrated air source can treat the humidity of the input air, so that the influence of the humidity on the generation efficiency of nitrogen oxides in the arc reaction chamber is reduced;

3) The internal integrated air source can treat the humidity of the input air, so that more impurity gas is generated after the water vapor enters the arc reaction chamber;

4) The internal integrated air source can treat the humidity of the input air, reduce the possibility of condensation of water vapor in the system and prevent the corrosion of the system by acidic liquid formed after NO ₂ is dissolved in water;

5) The internal integrated air source can treat the humidity of the input air, and reduce the influence of water vapor on the effect of filtering impurity gas by the filter material after entering the filter;

6) Releasing the internal pressure of the system after the equipment is stopped, balancing the internal pressure and the external pressure, and prolonging the service life of the equipment;

7) Purging the device after stopping the treatment, ensuring that the gas passage inside the device is filled with air, and preventing NO from being oxidized into NO ₂ in the system to affect the subsequent treatment of the patient;

8) The use of the shut-off valve allows for replacement of the filter without stopping the device, depressurizing, and leakage of NO therapeutic gas, thereby reducing the time for discontinuing treatment due to replacement of the filter.

In practice, the therapeutic gas delivery device described herein may be used to deliver NO therapeutic gas to a ventilator. The gases are mixed prior to inhalation by the patient. For example, a patient with 500 milliliters tidal volume may need to inhale NO at a concentration of 10ppm, and the therapeutic gas delivery device may need to release 50 milliliters of NO at a concentration of 100ppm when the patient inhales NO gas to ventilator air mixing ratio is 1:9. This can be achieved with a gas reservoir of about 35 ml in the therapeutic gas delivery device, which is maintained at an internal pressure of 0.5bar, or with a gas reservoir pressure of 1bar, which is also maintained at a gas storage volume of about 25 ml. The pressure in the inspiratory limb of the ventilator is relatively low and negligible. The device is compact and lightweight, and the compatibility of the device with respirators and other medical equipment is greatly improved.

If the mixing ratio in the above example is too high, this may undesirably dilute the ventilator's oxygen. On the other hand, a lower mixing ratio will result in less NO gas being released, allowing a smaller gas storage volume, but a higher concentration of NO gas must be obtained from the device. This requires more complex production methods, especially in the case of arc technology, which increases the production of nitrogen dioxide. Thus, there is an optimal range of mixing of NO gas with air in the therapeutic gas delivery device.

Another key point is the relationship between the pressure and volume of the gas reservoir, the higher the pressure, the smaller the volume required, but the higher the requirements on the tightness and reliability of the system.

In addition, the tidal volume of the patient can directly affect the desired size of the reservoir. Some people may have tidal volumes in excess of 1000 milliliters, even 1500 milliliters. In a preferred embodiment, the volume of the gas reservoir is designed to be less than the tidal volume of the patient. Adjusting the mixing ratio, gas storage pressure, and NO concentration helps to minimize the volume required by the gas storage.

Experience has shown that in the most efficient models, the volume of the gas reservoir should be less than 1500 ml, ideally less than 1200 ml, more ideally less than 1000ml, and even more ideally less than 800 ml. In some cases, a volume of less than 200 ml is sufficient. The cross-sectional area of the gas reservoir is preferably between 1 square millimeter and 4 square centimeters (inclusive), and more preferably within 2 square centimeters (inclusive).

The foregoing description is by way of example only. They are not intended to be exhaustive or to be limited to the precise forms or embodiments disclosed. Modifications and adaptations to the embodiments will be apparent from a consideration of the specification and practice of the disclosed embodiments. For example, the described embodiments include hardware, but systems and methods consistent with the present disclosure may be implemented in hardware and software. Furthermore, although certain components are described as being connected to one another, the components may be integrated with one another or distributed in any suitable manner.

Moreover, although illustrative embodiments have been described herein, the scope thereof includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., across various embodiment aspects), adaptations or alterations based on the present disclosure. Furthermore, the steps of the disclosed methods may be modified in any manner, including rearrangement steps or insertion or deletion steps.

The features and advantages of the present disclosure are apparent from the detailed description. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

It is understood that the above-described embodiments may be implemented by hardware, software (program code), or a combination of hardware and software. If implemented in software, may be stored in the computer readable medium described above. The software, when executed by a processor, may perform at least some of the steps of the disclosed methods.

In the foregoing specification, embodiments of the invention have been described with reference to numerous specific details that may vary from one embodiment to another. Certain adaptations and modifications of the described embodiments can be made. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure herein. For reference, the specification and examples are intended, with the true scope and spirit of the disclosure being indicated by the following claims. Furthermore, the order of steps shown in the figures is for illustrative purposes only and does not imply that any given method of operation must perform all of the steps, nor is it limited to any particular order of steps. Thus, one skilled in the art will appreciate that the steps may be performed in a different order when the same method is performed. 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.

Claims

1. A therapeutic gas delivery device comprising:

A therapeutic gas source (1) for generating a therapeutic gas;

A gas storage unit (2) connected downstream of the therapeutic gas source (1), the gas storage unit (2) being used to store at least part of the therapeutic gas from the therapeutic gas source (1);

A gas output unit connected downstream of the gas storage unit (2), the gas output unit being configured to be connected to an inhalation branch of a respiratory device and outputting therapeutic gas to the inhalation branch of the respiratory device as required;

a gas replenishing section (4) connected to the gas storage section (2), the gas replenishing section (4) being used to replenish gas to the gas storage section (2);

a flow control unit (6) connected to the gas output portion (3), for controlling the amount of therapeutic gas delivered through the gas output portion (3); and

A pressure control unit (5) connected to the gas storage unit (2) is used to stabilize the pressure in the gas storage unit (2) and keep the pressure inside the gas storage unit (2) higher than the pressure in the inhalation branch of the breathing device.

2. The therapeutic gas delivery device of claim 1, wherein

The pressure control unit (5) is configured to stabilize the pressure in the gas storage unit (2) at a preset value greater than 120 cm H2O.

3. The therapeutic gas delivery device of claim 1, wherein

When the patient downstream of the gas output section (3) is in the exhalation phase, or the flow rate of the therapeutic gas output to the patient by the gas output section (3) is lower than the flow rate of the therapeutic gas provided by the therapeutic gas source (1), at least a portion of the therapeutic gas provided by the therapeutic gas source (1) is stored in the gas storage section (2).

4. The therapeutic gas delivery device of claim 3, wherein

When the flow rate of therapeutic gas outputted by the gas output portion (3) to the patient exceeds the flow rate provided by the therapeutic gas source (1), the therapeutic gas stored in the gas storage portion (2) is spontaneously outputted to the gas output portion (3).

5. The therapeutic gas delivery device of claim 1, wherein

The gas supplemented by the gas supplementing unit (4) includes air, nitrogen or therapeutic gas.

6. The therapeutic gas delivery device of claim 1, wherein

The inlet of the gas replenishing part (4) is connected to a power source to ensure the driving force for replenishing gas to the gas storage part (2), wherein the power source includes a high-pressure gas cylinder, a central gas source of a hospital, or an air pump.

7. The therapeutic gas delivery device of claim 1, wherein

When the air supply unit (4) is connected to the power source, the pressure control unit (5) comprises a back pressure valve (5a), wherein the back pressure valve (5a) is configured as

When the pressure in the gas storage section (2) exceeds a preset value, the gas in the gas storage section (2) is released through the pressure relief port of the back pressure valve (5a) to stabilize the pressure in the gas storage section (2).

8. The therapeutic gas delivery device of claim 7, wherein

When the power source connected to the gas supply unit (4) includes a high-pressure gas cylinder or an air pump, the pressure control unit (5) includes a combination of a pressure reducing valve (5b) and a back pressure valve (5a), wherein:

The pressure reducing valve (5b) is used to stabilize the input pressure from the power source.

9. The therapeutic gas delivery device of claim 1, wherein

The pressure control unit (5) comprises a valve component which has both a pressure reducing function and a back pressure function.

10. The therapeutic gas delivery device of claim 1, wherein

The pressure control unit (5) includes a first mass flow controller, which is further coupled to the gas supply unit (4) to control the flow rate of the gas supplied from the gas supply unit (4) to the gas storage unit (2).

11. The therapeutic gas delivery device of claim 10, wherein

An overflow gas path is arranged between the first mass flow controller and the gas storage part (2), wherein the overflow gas path comprises a second mass flow controller, and the second mass flow controller is used to control the flow rate of the gas released from the gas storage part (2).

12. The therapeutic gas delivery device of claim 1, wherein

The pressure control unit (5) comprises a combination of a pressure sensor and an electric control valve, wherein

The pressure sensor is configured to detect the pressure in the gas storage portion (2), and

The electric control valve is configured to control an opening according to the detected pressure to adjust the air flow through the opening.

13. The therapeutic gas delivery device of claim 12, wherein

Electric control valves include solenoid valves or proportional valves.

14. The therapeutic gas delivery device of claim 1, wherein

The cross-sectional area of the gas storage portion (2) is between 1 mm ² and 4 cm ² .

15. The therapeutic gas delivery device of claim 1, wherein

The gas replenishing section (4) is further connected to the treatment body gas source (1) and is configured to replenish gas to the treatment body gas source (1).

16. The therapeutic gas delivery device of claim 1, wherein

The therapeutic gas source (1) comprises an electrochemical on-the-fly preparation device for electrochemically generating nitric oxide (NO), and

The gas supply unit (4) is further configured to input a purge gas to the therapeutic gas source (1) for purging the electrode and the nitric oxide generated electrochemically, wherein the purge gas comprises air or nitrogen.

17. The therapeutic gas delivery device of claim 1, wherein

The therapeutic gas source (1) comprises an instantaneous preparation device for generating NO using an arc method, and

The gas supply unit (4) is configured to input reaction gas into the therapeutic gas source (1), wherein the electrodes inside the reaction chamber of the therapeutic gas source (1) are used to generate NO by high-voltage electric shock, and the generated NO is carried out by the excess part of the reaction gas.

18. The therapeutic gas delivery device of claim 17, wherein

The reaction gas includes air or a gas containing oxygen and nitrogen.

19. The therapeutic gas delivery device of claim 1, wherein

The gas replenishment unit (4) is configured to be connected to the gas storage unit (2) and the therapeutic gas source (1) at the same time, and to input gas into the gas storage unit (2) and the therapeutic gas source (1) through a power source.

20. The therapeutic gas delivery device of claim 1, wherein

The gas replenishment section (4) comprises a first replenishment section connected to the gas storage section (2), and a second replenishment section connected to the therapeutic gas source (1), wherein the first replenishment section and the second replenishment section are connected to different power sources to respectively deliver different gases to the gas storage section (2) and the therapeutic gas source (1).

21. The therapeutic gas delivery device of claim 20, wherein

The first supply portion is configured to input air into the gas storage portion (2); and

The second supply part is configured to input nitrogen gas to the therapeutic gas source (1).

22. The therapeutic gas delivery device of claim 1, further comprising

A second flow control unit (7) installed downstream of the therapeutic gas source (1) is used to control the flow rate of the therapeutic gas output from the therapeutic gas source (1).

23. The therapeutic gas delivery device of claim 1, further comprising

A second flow control unit (7) installed upstream of the therapeutic gas source (1) is used to control the gas flow entering the therapeutic gas source (1).

24. The therapeutic gas delivery device of claim 1, wherein

The therapeutic gas includes one or more of NO, CO, _H2S or _H2 .