System and method for delivering nitric oxide gas

Abstract

Systems and methods for delivering nitric oxide gas are disclosed. According to one embodiment, a nitric oxide gas delivery system can include a nitric oxide (NO) source to provide NO gas; a plurality of port indicators surrounding a plurality of respective gas ports, wherein each port indicator is configured to display a color; and an electronic control circuit configured to cause the plurality of port indicators to display the color based on a flow of the NO gas delivered through the respective gas port.

Description

Related applications

[0001] This application claims the benefits of U.S. Provisional Application No. 63 / 595,987, filed November 3, 2023, and U.S. Provisional Application No. 63 / 596,002, filed November 3, 2023. The entire teachings of the above applications are incorporated herein by reference. Technical Field

[0002] This invention relates to systems and methods for conveying nitric oxide gas. Background Technology

[0003] Nitric oxide (NO) delivery systems deliver NO to the breathing circuit of a mechanical ventilator at controlled concentrations. Such systems typically require a gas monitoring system (with an alarm) to measure the concentrations of NO, nitrogen dioxide (NO2), and oxygen (O2) in the ventilator's breathing circuit immediately before the patient inhales via a gas sampling line.

[0004] However, the current delivery system does not provide feedback or confirmation to indicate whether the set NO concentration or flow rate is indeed being delivered. Furthermore, for delivery systems with redundant NO sources, the current system fails to notify users that the backup NO source is being used to maintain primary ventilation support and that alternative delivery modes are no longer available. The current system also fails to provide direct user feedback when NO concentrations exceed or fall below set limits. Finally, for current systems supporting more than one gas delivery method or two or more gas output sources, this can lead to confusion about which port contains which gas.

[0005] Therefore, there is an urgent need for systems and methods for transporting NO gas that can overcome the above-mentioned shortcomings. Summary of the Invention

[0006] This invention provides a simplified overview of some concepts, which will be further described in the detailed embodiments below. This invention does not identify any key or essential features of the claimed subject matter, nor does it limit its scope.

[0007] This invention discloses a system and method for delivering nitric oxide gas.

[0008] According to one embodiment, a nitric oxide gas delivery system may include: at least one nitric oxide (NO) gas generator to generate NO gas; a plurality of port indicator lights surrounding a respective gas port, wherein each port indicator light is configured to display a color; and electronic control circuitry configured to cause one or more port indicator lights to display the color based on at least one of the following: (i) the state of the at least one NO gas generator, and (ii) the flow rate of NO gas delivered through the respective gas port.

[0009] According to one embodiment, the port indicator light illuminates when the corresponding gas port is activated.

[0010] According to one embodiment, the color displayed by the port indicator light indicates whether NO gas of a set concentration is being delivered through the corresponding gas port.

[0011] According to one embodiment, the port indicator light is configured to: (i) display a first color if NO gas is being delivered through the corresponding gas port at a set concentration; (ii) display a second color if NO gas is being delivered through the corresponding gas port at a concentration different from the set concentration; and (iii) display a third color if no NO gas is being delivered through the corresponding gas port at all.

[0012] According to one embodiment, the gas port corresponds to a gas outlet.

[0013] According to one embodiment, the gas port corresponds to one of the NO delivery outlet and the manual resuscitation airbag outlet.

[0014] According to one embodiment, the system includes two NO gas generators.

[0015] According to one implementation, the two NO gas generators operate simultaneously.

[0016] According to one implementation, only one of the two NO gas generators is operated at a time.

[0017] According to one implementation, one of the port indicator lights displays a first color during the operation of the first NO gas generator and a second color during the operation of the second NO gas generator.

[0018] According to one embodiment, the NO gas is generated from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

[0019] According to one embodiment, the system further includes a graphical user interface display, wherein the graphical user interface display is configured to display the status of the at least one NO gas generator.

[0020] According to one embodiment, the system includes a gas sampling line port, wherein the graphical user interface display is configured to display the status of the gas sampling line connected to the breathing circuit.

[0021] According to one embodiment, the graphical user interface is also configured to receive user input of a set concentration (also referred to herein as a “dosage”) of the NO gas to be delivered. A physician with ordinary skills in the art can easily determine and prescribe the required NO gas concentration. For example, a physician may begin administering NO gas at a concentration below that required to achieve the desired therapeutic effect, and then gradually increase the concentration until the desired effect is achieved.

[0022] In some embodiments, the set concentration of NO gas is from about 1 ppm to about 1,000 ppm. In some embodiments, the set concentration of NO gas is from about 1 ppm to about 600 ppm. In some embodiments, the set concentration of NO gas is less than about 1,000 ppm, or less than about 800 ppm, or less than about 600 ppm, or less than about 500 ppm, or less than about 300 ppm, or less than about 200 ppm, or less than about 160 ppm, or less than about 100 ppm, or less than about 50 ppm, or less than about 20 ppm. For example, the set concentration of NO gas is approximately 10 ppm, 20 ppm, 25 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, 130 ppm, 150 ppm, 160 ppm, 180 ppm, 200 ppm, 220 ppm, 240 ppm, 260 ppm, 280 ppm, 300 ppm, 350 ppm, 400 ppm, 450 ppm, 500 ppm, 550 ppm, or approximately 600 ppm.

[0023] According to one embodiment, the system further includes a light strip, wherein the light strip is configured to display color based on (i) the state of at least one NO gas generator and (ii) the flow rate of NO gas delivered through a corresponding gas port.

[0024] According to one embodiment, the system further includes a bottom housing, wherein the bottom housing includes: (i) at least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and (ii) a mounting bracket including at least one receiving portion for receiving the at least one external plunger.

[0025] According to another embodiment, a nitric oxide (NO) gas delivery system may include: an NO source for providing NO gas; a plurality of port indicator lights surrounding a corresponding gas port, wherein each of the port indicator lights is configured to display a color; and electronic control circuitry configured to enable the one or more port indicator lights to display the color based on the flow rate of NO gas delivered through the corresponding gas port.

[0026] According to one embodiment, the port indicator light illuminates when the corresponding gas port is activated.

[0027] According to one embodiment, the color displayed by the port indicator light indicates whether NO gas of a set concentration is being delivered through the corresponding gas port.

[0028] According to one embodiment, the port indicator light is configured to: (i) display a first color if NO gas is being delivered through the corresponding gas port at the set concentration; (ii) display a second color if NO gas is being delivered through the corresponding gas port at a concentration different from the set concentration; and (iii) display a third color if no NO gas is being delivered through the corresponding gas port.

[0029] According to one embodiment, the gas port corresponds to the gas outlet.

[0030] According to one embodiment, the gas port corresponds to one of the NO delivery outlet, the manual resuscitation airbag inlet, and the manual resuscitation airbag outlet.

[0031] According to one implementation, the NO source is either a container for storing NO or a NO generator.

[0032] According to one embodiment, the NO generator generates NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

[0033] According to one embodiment, the system includes a graphical user interface display, wherein the graphical user interface display is configured to display the state of the NO generator.

[0034] According to one embodiment, the graphical user interface is also configured to receive user input for a set concentration of NO gas to be delivered.

[0035] According to one embodiment, the system further includes a bottom housing, wherein the bottom housing includes: (i) at least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down the at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and (ii) a mounting bracket including at least one receiving portion for receiving the at least one external plunger.

[0036] According to another embodiment, a nitric oxide gas delivery system may include: (i) a first subsystem for generating nitric oxide (NO) gas, the first subsystem including a first NO generator and a mass flow controller, wherein the mass flow controller controls the airflow rate entering the first NO generator; (ii) a second NO subsystem for generating NO gas, the second subsystem including a second NO generator; (iii) at least one gas outlet port for delivering NO gas generated by one of the first subsystem or the second subsystem; and (iv) an electronic control circuit configured to select one of the first subsystem and the second subsystem to supply NO gas to the at least one gas outlet port based on the airflow rate associated with the mass flow controller.

[0037] According to one embodiment, the air velocity refers to the historical average air velocity associated with the mass flow controller.

[0038] According to one implementation, the historical average air velocity is calculated based on historical velocity data tracked over a time period.

[0039] According to one implementation, the time period is from 1 second to 5 minutes.

[0040] According to one embodiment, the system further includes an NO delivery module in fluid communication with the at least one gas outlet port, wherein the NO delivery module includes a breathing gas flow sensor configured to sense the breathing gas flow rate.

[0041] According to one embodiment, the electronic control circuit is configured to select the second subsystem to supply NO gas to the at least one gas outlet port when an interruption in the respiratory gas flow rate data is detected.

[0042] According to one implementation, the interruption is based on a fault in the respiratory gas flow sensor.

[0043] According to one embodiment, the respiratory gas flow rate data is provided to the electronic control circuit by the NO delivery module.

[0044] According to one embodiment, the electronic control circuit is configured to select the second subsystem to supply NO gas to the at least one gas outlet port when an interruption is detected in the first subsystem.

[0045] According to one embodiment, the interruption refers to one of the situations in which the first NO generator completely or partially stops generating NO gas.

[0046] According to one embodiment, the interruption is caused by the first NO generator generating excessive NO gas.

[0047] According to one embodiment, the provided NO gas has one of a fixed concentration or a variable concentration.

[0048] According to one embodiment, the first NO gas generator and the second NO gas generator include a plasma chamber encapsulating two electrodes separated by a gap.

[0049] According to one embodiment, the first NO gas generator and the second NO gas generator each generate NO gas from liquid nitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3).

[0050] According to one embodiment, the system further includes a bottom housing, wherein the bottom housing includes: (i) at least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down the at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and (ii) a mounting bracket including at least one receiving portion for receiving the at least one external plunger.

[0051] According to another embodiment, a method for delivering nitric oxide gas may include: (i) generating nitric oxide (NO) gas using a first subsystem, wherein the first subsystem includes a first NO generator and a mass flow controller, wherein the mass flow controller controls the airflow rate entering the first NO generator; (ii) generating NO gas using a second subsystem, wherein the second subsystem includes a second NO gas generator, wherein the NO gas generated by the second subsystem is based on an airflow rate associated with the mass flow controller; and (iii) providing the NO gas generated by the first subsystem or the second subsystem to at least one gas outlet port.

[0052] According to one embodiment, the air velocity refers to the historical average air velocity associated with the mass flow controller.

[0053] According to one implementation, the historical average airflow velocity is calculated based on historical flow data tracked over a time period.

[0054] According to one implementation, the time period is from 1 second to 5 minutes.

[0055] According to one embodiment, when an interruption in the respiratory gas flow rate is detected, NO gas generated by the second subsystem is delivered to the at least one gas outlet port.

[0056] According to one implementation, the interruption is based on a fault in the respiratory gas flow sensor.

[0057] According to one embodiment, when an interruption is detected in the first subsystem, NO gas generated by the second subsystem is delivered to the at least one gas outlet port.

[0058] According to one embodiment, the interruption refers to one of the situations in which the first NO generator completely or partially stops generating NO gas.

[0059] According to one embodiment, the interruption is caused by the first NO generator generating excessive NO gas.

[0060] According to one embodiment, the provided NO gas has one of a fixed concentration or a variable concentration.

[0061] According to one embodiment, the first NO gas generator and the second NO gas generator each include a plasma chamber, the plasma chamber encapsulating two electrodes separated by a gap.

[0062] According to one embodiment, the first NO gas generator and the second NO gas generator each generate the NO gas from liquid nitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3).

[0063] According to another embodiment of the present invention, a gas sampling system for a medical gas delivery device may include: a gas sampling line; a pump; and a pressure relief system, wherein: (i) the pump is configured to draw medical gas into the gas sampling system through the gas sampling line, and (ii) the pressure relief system is configured to release positive excess pressure in the gas sampling system through an outlet.

[0064] According to one implementation, the excessive pressure refers to (i) a pressure amount that exceeds a predetermined threshold or (ii) causes a change from negative pressure to positive pressure.

[0065] According to one implementation, the predetermined threshold is 0.01 to 1.0 psig.

[0066] According to one embodiment, the excessive pressure is caused by positive pressure in the gas sampling line.

[0067] In one embodiment, the positive pressure is generated by a breathing device in fluid communication with the gas sampling line.

[0068] In one embodiment, the breathing device is one of a high-flow nasal cannula, a mechanical ventilator, and a high-frequency ventilator.

[0069] In one embodiment, the pressure relief system includes a valve and a filter.

[0070] In one embodiment, the valve is a bypass valve, wherein the bypass valve is configured to release any pressure exceeding the predetermined threshold or to release pressure that causes a change from negative pressure to positive pressure.

[0071] In one implementation, the valve is connected to a processor and is actuated when it is determined that the pump parameters are below a certain threshold.

[0072] In one embodiment, the pump parameters are one of vacuum pressure, vacuum pump power, pump input current, pump voltage, pulse width modulation (PWM) pump control, and pump motor speed.

[0073] In one embodiment, the valve is connected to a processor and is actuated when it is determined that a flow parameter related to the medical gas exceeds a specific threshold, wherein the flow parameter is measured by a flow sensor in fluid communication with the pressure relief system.

[0074] In one implementation, the flow parameter is the flow rate.

[0075] In one embodiment, the filter is configured to protect the valve's forward flow performance from contamination.

[0076] In one embodiment, the pressure relief system is in fluid communication with the gas sampling line.

[0077] In one embodiment, the medical gas includes nitric oxide (NO) gas.

[0078] In one embodiment, the NO gas is provided by an NO source.

[0079] In one implementation, the NO source is either a container for storing NO or a NO generator.

[0080] According to one embodiment, the NO generator generates the NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

[0081] According to another embodiment, a gas sampling system for a medical gas delivery device may include: a gas sampling line including a filter; a pump; and a processor. The pump is configured to draw medical gas into the gas sampling system through the gas sampling line, and the processor is configured to: (i) determine pump-related input parameters required to maintain a constant flow rate in the gas sampling line; (ii) determine real-time information of the gas sampling line based on the input parameters; and (iii) update a user interface display based on the determined real-time information.

[0082] According to one implementation, the input parameters are one of vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM pump control, and pump motor speed.

[0083] According to one implementation, the real-time information is related to the functional lifespan of the gas sampling pipeline.

[0084] According to one implementation, the real-time information is presented on the user interface display in the form of a bar chart.

[0085] According to one embodiment, the bar chart includes a first visual indicator having a first contrasting color above it and a second contrasting color below it, wherein the first visual indicator decreases as the gas sampling line is used.

[0086] According to one embodiment, the bar chart includes a second visual indicator located below the first visual indicator, wherein the second visual indicator corresponds to an alarm threshold.

[0087] According to one embodiment, the bar chart is recalibrated when the gas sampling line is replaced.

[0088] According to one embodiment, the filter removes particulate matter from the gas sampling line.

[0089] According to one embodiment, the medical gas includes nitric oxide (NO) gas.

[0090] According to one embodiment, the NO gas is provided by an NO source.

[0091] According to one implementation, the NO source is either a container for storing NO or a NO generator.

[0092] According to one embodiment, the NO generator generates the NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

[0093] According to another embodiment, a method for monitoring real-time information of a gas sampling line in a gas sampling system may include: (i) determining input parameters of a pump required to maintain a constant flow rate in the gas sampling line, wherein the pump draws medical gas into the gas sampling system through the gas sampling line; (ii) determining real-time information of the gas sampling line based on the input parameters; and (iii) updating a user interface display based on the determined real-time information.

[0094] According to one implementation, the input parameters are one of vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM pump control, and pump motor speed.

[0095] According to one implementation, the real-time information is related to the functional lifespan of the gas sampling pipeline.

[0096] According to one embodiment, the real-time information is displayed on the user interface display in the form of a bar chart.

[0097] According to one embodiment, the bar chart includes a first visual indicator having a first contrasting color above it and a second contrasting color below it, wherein the first visual indicator decreases as the gas sampling line is used.

[0098] According to one embodiment, the bar chart includes a second visual indicator located below the first visual indicator, wherein the second visual indicator corresponds to an alarm threshold.

[0099] According to one embodiment, the bar chart is recalibrated when the gas sampling line is replaced.

[0100] According to one embodiment, the medical gas includes nitric oxide (NO) gas.

[0101] According to one embodiment, the NO gas is provided by an NO source.

[0102] According to one implementation, the NO source is either a container for storing NO or a NO generator.

[0103] According to one embodiment, the NO generator generates the NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

[0104] According to one embodiment, the plurality of port indicator lights can provide the user with visual confirmation of: impaired (or unimpaired) gas availability, unavailability of alternative delivery modes, and / or from which pipe or outlet port the gas is flowing and at what concentration. Each of the plurality of port indicator lights can display two or more (preferably three or more) different colors to indicate a signal of the output status to be monitored. For example, a first color (e.g., blue) can be used to illuminate the main gas delivery outlet to confirm that the main gas delivery is within a set limit. For example, an NO concentration sensor can be used to monitor the concentration of NO gas. When NO production stops or the NO gas container / storage tank becomes empty, the NO gas concentration may fall below a set concentration. On the other hand, when NO production exceeds the required amount or the mixing and dilution of NO gas with medical gases stops, the NO gas concentration may exceed a set concentration limit. In this case, when the concentration falls outside the specified limit, the port indicator light can change to a color contrasting with the first color (e.g., red). In one embodiment, a third color can be used to confirm a third state. For example, when NO delivery is switched to a backup NO source (e.g., a secondary NO generator) due to reasons such as a failure of the primary NO generator to deliver NO, the port indicator lights may change to a third contrasting color (e.g., amber). In other embodiments, the plurality of port indicator lights may not display a specific color, but rather indicate different conditions by flashing at different frequencies.

[0105] Furthermore, according to one embodiment, the backup NO source can be activated by a user selecting a manual button, or automatically in the event of certain detectable faults. Once activated, at least one of the manual button and the port indicator light surrounding the main gas outlet can be illuminated in the same color (e.g., amber). Additionally, text indicating the backup mode can be displayed simultaneously.

[0106] According to one embodiment, the plurality of port indicator lights can be controlled by an electronic control circuit programmed to operate a light engine to display visible light of a specific color. For example, the light engine can be activated if a gas delivery mass flow controller is supplying an appropriate amount of NO-containing gas in liters per minute.

[0107] According to one implementation, the port indicator light can also be activated around other gas ports, such as the manual resuscitation airbag outlet.

[0108] According to one embodiment, the plurality of port indicator lights can indicate to the user that the correct concentration and quantity of gas can be delivered without the need for gas monitoring. For manual resuscitation bag outlets, the port indicator lights can also provide a higher level of safety by avoiding the need to move or replace critical components associated with the gas sampling system, such as gas sampling lines.

[0109] According to one embodiment, the system may include an inclined recessed feature located below the bottom of the unit, enabling it to be secured to a transport trolley, cart, or wheeled system (e.g., a hospital bed). Attached Figure Description

[0110] Figure 1A This is a schematic diagram of the front of a nitric oxide delivery system, showing in particular the gas port.

[0111] Figure 1B This is a perspective view of a system according to an embodiment of the present invention.

[0112] Figure 2 This is a schematic diagram of a graphical user interface display according to an embodiment of the present invention.

[0113] Figure 3 This is a cross-sectional view of a plasma chamber according to one embodiment of the present invention, showing the main components of the plasma chamber design.

[0114] Figure 4 This is a schematic diagram of a nitric oxide generator according to an embodiment of the present invention, showing the components of the system and their electrical and pneumatic connections.

[0115] Figure 5 This is an electronic schematic diagram of a pulse discharge driving circuit according to an embodiment of the present invention.

[0116] Figure 6 This is a schematic diagram of a nitric oxide generator according to another embodiment of the present invention, showing the components of the system and their electrical and pneumatic connections.

[0117] Figure 7A This is a schematic diagram of a nitric oxide generation system including two nitric oxide generators according to one embodiment of the present invention.

[0118] Figure 7B This is according to one embodiment of the present invention. Figure 7A The diagram shows a nitric oxide delivery module.

[0119] Figure 8 This is a schematic diagram of a gas sampling system according to one embodiment of the present invention.

[0120] Figure 9 A portion of a region highlighting the status of a gas sampling pipeline is shown in a graphical user interface display according to an embodiment of the present invention.

[0121] Figure 10A This is a schematic diagram of the bottom outer shell of the nitric oxide delivery system.

[0122] Figure 10B A side view of the bottom casing is shown.

[0123] Figure 10C A cross-sectional view of the bottom casing according to one embodiment of the present invention is shown. Detailed Implementation

[0124] The following detailed description refers to the accompanying drawings, which form part of this application, illustrating specific exemplary embodiments by way of illustration. Other embodiments may be made without departing from the scope of this disclosure.

[0125] Furthermore, this invention covers all variations, combinations, and arrangements that incorporate more than one limitation, element, clause, and descriptive term from one or more of the listed claims into another claim. For example, any claim dependent on another claim may be modified to include more than one limitation found in any other claim dependent on the same basic claim. When elements are presented in list form (e.g., in Markush group format), each subgroup of that element is also disclosed, and any element may be removed from that group. It should be understood that, generally, when the invention or aspects thereof are referred to as “comprising” a particular element and / or feature, certain embodiments or aspects thereof constitute, or are substantially constitute, of those elements and / or features. For simplicity, these embodiments are not described verbatim herein.

[0126] As used in this article, unless the context clearly indicates otherwise, the singular forms “a,” “one,” and “the” include both singular and plural referents.

[0127] Throughout this disclosure, various aspects of the invention may be presented in the form of a range. It should be understood that the description in the form of a range is for convenience and brevity only and should not be construed as a hard limitation on the scope of the invention. When a range is given, the endpoints are included. Furthermore, unless otherwise stated or apparent from the context and from the understanding of one of ordinary skill in the art, values ​​expressed in range may take any specific value or subrange within the stated range in different embodiments of the invention, accurate to one-tenth of the lower limit unit of the range, unless the context expressly specifies otherwise. For example, the range 1 to 50 is understood to include any number, combination of numbers, or subrange of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50, as well as all intermediate decimal values ​​between the aforementioned integers, such as 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, and 1.9. Regarding subranges, "nested subranges" extending from either endpoint of the range are specifically considered. For example, nested subranges of the exemplary range of 1 to 50 may include 1 to 10, 1 to 20, 1 to 30 and 1 to 40 in one direction, or 50 to 40, 50 to 30, 50 to 20 and 50 to 10 in another direction.

[0128] Figure 1A This is a schematic diagram of the front of the NO delivery system, showing the gas port in particular. Figure 1B This is a perspective view of the system. As shown in the figure, the NO delivery system 1 includes: multiple gas ports 2, 3 and 4, and corresponding port indicator lights 2a, 3a and 4a; a nitric oxide delivery module (NDM) cable port 5; a gas sampling line port 6; a user interface display 7; a knob 7a; a light strip 7b; a speaker 7c; and a filter latch 8.

[0129] According to one embodiment, gas port 2 corresponds to the main NO delivery outlet, gas port 3 corresponds to the manual resuscitation cuff outlet, and gas port 4 corresponds to the manual resuscitation cuff inlet. In this respect, gas ports 3 and 4 are part of the cuff system, wherein gas port 4 is used to connect to an air / oxygen source via an oxygen conduit or equivalent to provide external airflow, and gas port 3 is used to connect to a manual resuscitator for manual ventilation of the patient.

[0130] According to one embodiment, port indicator lights 2a, 3a, and 4a can be controlled by an electronic control circuit programmed to operate a corresponding light engine to display visible light of a specific color. For example, the light engine can be activated if the gas delivery mass flow controller is supplying the appropriate amount of NO-containing gas in liters per minute. The displayed color can represent different conditions. For example, a first color can be used to indicate a first condition, i.e., normal operation and delivery of NO gas; a second color can be used to indicate a second condition, i.e., improper operation or delivery of NO gas; and a third color can be used to indicate a third condition, i.e., a state between the first and second conditions. According to another embodiment, the port indicator lights may not display a specific color, but instead flash at different frequencies to indicate different conditions. In this respect, the flashing can correspond to the urgency of the situation. For example, in the first state, since the equipment is operating normally, there may be no flashing. In the second state, due to abnormal equipment operation, there may be a higher frequency of flashing. Finally, in the third state, there may be a lower frequency.

[0131] According to one embodiment, NDM cable port 5 can be used to receive a cable from the NDM for measuring gas flow in the breathing circuit and delivering the NO gas mixture to the inspiratory branch of the breathing circuit.

[0132] According to one embodiment, gas sampling line port 6 can be used to receive a gas sampling line connected to the breathing circuit. In this respect, the gas sampling line is used to draw gas from the breathing circuit so that the concentrations of NO, NO2, and O2 can be measured and monitored in real time.

[0133] According to one embodiment, the user interface display 7 can be used to set the desired NO concentration or other parameters. In this regard, the user interface display 7 can be a touch screen. In this regard, the parameter to be set on the touch screen 7 can activate or open a menu to set the parameter. For example, the touch screen 7 can open a graphic containing + and / or – symbols, and / or a menu containing options (e.g., 5, 10, or 20 ppm), thereby allowing the NO concentration to be increased or decreased. According to another embodiment, the desired NO concentration can also be set via a knob 7a. The user interface display 7 can also be used to display one or more of the following states: (i) NO source, (ii) NO2 filter, (iii) gas sampling line, (iv) airbag system, (v) set NO concentration, (vi) measured NO concentration, (vii) measured NO2 concentration, (viii) measured O2 concentration, and / or (ix) power supply, these states being combined Figure 2 To provide a more detailed description.

[0134] According to one embodiment, similar to port indicator lights 2a, 3a, and 4a, light strip 7b can be controlled by an electronic control circuit programmed to operate a corresponding light engine to display visible light of a specific color, where the displayed color represents different conditions. In this respect, light strip 7b ensures that any important condition (e.g., alarm status) is clearly visible in a busy, multi-patient environment. According to one embodiment, light strip 7b remains off when the system is not in an alarm state, and changes to a first warning color (e.g., red) when a more urgent alarm is triggered (e.g., when the battery has only a few minutes of life left), or changes to another warning color (e.g., amber) when the alarm urgency is lower (e.g., the NO2 filter is about to need replacement).

[0135] According to one embodiment, the speaker 7c can be used to provide an audible alarm in conjunction with visual indications provided by port indicator lights 2a, 3a and 4a, user interface display 7 and / or light bar 7b.

[0136] Figure 2 This is a schematic diagram of a graphical user interface display according to an embodiment of the present invention. As shown, the user interface display 7 shows a user interface layout 10, which includes multiple dedicated areas, such as: (i) NO source status area 11, (ii) NO2 filter status area 12, (iii) gas sampling line status area 13, (iv) airbag system status area 14, (v) set NO concentration area 15, (vi) measured NO concentration area 16, (vii) measured NO2 concentration area 17, (viii) measured O2 concentration area 18, (ix) power status area 19, and (x) text area 20.

[0137] According to one embodiment, the NO source status area 11 displays the status of one or more NO sources in use. Specifically, area 11 shows whether a primary NO source, a backup, or a secondary NO source is being used. In this regard, if a primary NO source is being used, the top NO source graphic 11a will be illuminated. Similarly, if a backup or secondary source is being used, the bottom NO source graphic 11b will be illuminated. The NO source can come from a container storing NO or a NO generator. According to one embodiment, the NO generator can generate NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3).

[0138] According to one embodiment, the NO2 filter status area 12 displays the status of the NO2 filter in use. The status of the NO2 filter can be presented by the number of hours / time remaining before the filter should be replaced and / or the percentage of remaining time. According to one embodiment, the filter status can also be displayed using a ball float graphic, which moves around a circle in a specific direction as the NO2 filter is consumed. For example, as... Figure 2 As shown, the float pattern can move counterclockwise as the NO2 filter is consumed. However, in another embodiment, the float pattern can move clockwise, or it can be represented by another pattern and move in vertical, horizontal, diagonal, or other directions.

[0139] According to one embodiment, a gas sampling line status area 13 displays the status of the connected gas sampling line. Area 13 includes a bar graph 13a, which includes a first visual indicator 13b (e.g., a float) and a second visual indicator 13c (e.g., a horizontal line). In this respect, the float 13b can be associated with a first contrasting color above it and a second contrasting color below it. The float 13b can descend as the gas sampling line is used. The line 13c can be an indicator of when the gas sampling line should be replaced. Thus, the position of the float 13b is an indication of the functional lifespan of the gas sampling line. Of course, other alternative diagrams can also be used. The bar graph can be inverted, or replaced with a dial, a pie chart, or a numerical indicator (e.g., a percentage of remaining lifespan). The urgency of replacement can be conveyed through color. For example, amber can be used to indicate that replacement should be completed as soon as possible, while red can be used to indicate that the component should be replaced immediately. These indicators will help prevent users from performing unnecessary maintenance operations or ignoring necessary maintenance, thereby avoiding gas monitoring malfunctions, high-priority alarms, and / or bedside clinical crises. In addition, it can prevent excessive replacement of gas sampling lines due to institutionalized replacement plans, thereby reducing associated treatment costs, user maintenance, and / or unplanned bedside visits due to handling alarms related to gas monitoring sampling line failures.

[0140] According to one embodiment, the airbag system area 14 displays the status of the connected manual resuscitator. The airbag system area may include at least one of a measured flow rate graph 14a and an NO2 filter graph 14b. The measured flow rate graph 14a displays the gas flow rate through gas port 3. Similarly, the NO2 filter graph 14b displays the status of the NO2 filter associated with gas port 3. The status of the NO2 filter can be presented by the number of hours / time remaining and / or the percentage of remaining time before the filter should be replaced. According to one embodiment, the filter status can also be displayed by a float graph that moves around a circle in a specific direction as the NO2 filter is consumed. For example, the float graph may move counterclockwise as the NO2 filter is consumed. However, in another embodiment, the float graph may move clockwise around a circle, or it may be represented by another graph and move in vertical, horizontal, diagonal, or other directions. Similar to the gas sampling line, the urgency of replacing the NO2 filter can be conveyed by color. For example, amber can be used to indicate that replacement should be completed as soon as possible, while red is used to indicate that the component should be replaced immediately.

[0141] According to one embodiment, the set NO concentration zone 15 displays the desired NO concentration set by the user. As described above, the NO concentration can be set using the user interface display 7 or the knob 7a.

[0142] According to one embodiment, the measured NO concentration range 16 displays the concentration measured in real time, and optionally, displays an upper limit 16a and a lower limit 16b of the range, beyond which an alarm will be issued (e.g., 15 to 55 ppm).

[0143] According to one embodiment, the measured NO2 concentration region 17 displays the real-time measured NO2 concentration, and optionally, displays an upper limit value 17a, which will trigger an alarm (e.g., 3 ppm) if the upper limit value is exceeded.

[0144] According to one embodiment, the measured O2 concentration region 18 displays the real-time measured O2 concentration, and optionally, displays an upper limit 18a and a lower limit 18b of a range beyond which an alarm will be issued (e.g., 50% to 90%).

[0145] According to one embodiment, the power status area 19 displays the status of the remaining battery life in system 1. This can be presented as a graphic 19a, which visually shows the battery depleting as it is being consumed. The remaining battery life can also be displayed in the form of remaining hours and / or a percentage. Furthermore, when the battery power begins to decrease (e.g., within the last 30 minutes before depletion), graphic 19a can change to a first warning color (e.g., amber), and if the power status becomes more critical (e.g., when less than 10 minutes of battery power remain), it changes to a second warning color (e.g., red). Similarly, graphic 19a can also display the status of the battery while it is charging.

[0146] According to one implementation, text area 20 may display descriptive banners related to more than one condition, such as “Airbag mode activated,” “Replace gas sampling line,” “Replace NO2 filter,” “Airbag flow reversed,” “NDM flow sensor malfunction,” etc.

[0147] According to one embodiment, during normal operation of system 1, NO is output through gas port 2 at the desired NO concentration. In this regard, once the gas delivery reaches within 20% of the set concentration, port indicator 2a will illuminate in a first color (e.g., blue). The concentration of the delivered gas can be determined based on the flow rate of NO gas delivered through gas port 2. This flow rate can be determined, for example, by a mass flow controller supplying NO gas through gas port 2.

[0148] According to one embodiment, during cuff mode, NO is output through gas ports 2 and 3. In this regard, the output concentration at gas port 3 can be set based on the desired NO concentration at gas port 2. Cuff mode can be initiated once a low-pressure air / O2 mixture is supplied to gas port 4. This gas can then be mixed with NO and output through gas port 3, which is subsequently connected to a manual resuscitator. Once the gas delivered through gas port 3 reaches within 20% of the desired NO concentration, port indicator 3a will illuminate in a first color. Under fault conditions, port indicator 3a can change color, for example, from blue to red. In cases where clinical NO delivery time is short, this method of directly indicating NO delivery reduces the need for gas monitoring. When gas port 3 is activated, the display can include more than one additional graphic, such as a graphic depicting a portable cuff with the word "on" (e.g., graphics 14a and / or 14b), and / or a banner with identifying text (e.g., "Cuff Mode On") in text area 20. Furthermore, measurements and / or settings of gas flow rates related to the cuff system can be illustrated, as shown in Figure 14a.

[0149] According to one implementation, in the event of a failure related to the main NO source, system 1 can switch to a standby mode. For example, switching can occur if the NO level falls outside the desired range. Switching can also occur if other components (e.g., the NDM flow sensor) fail. Switching can occur automatically or be manually activated. In standby mode, NO is maintained at a specific concentration and flow rate from the main delivery port (i.e., gas port 3). In this regard, port indicator 3a can be illuminated in a warning color (e.g., red or amber). Furthermore, to provide additional indication that the standby mode has been activated, graphic 11b can be illuminated, while graphic 11a can be displayed with an "X" above it. Additionally, text area 20 can display a message describing the specific failure, such as "NDM flow sensor failure." Simultaneously, light bar 7b can also temporarily flash to indicate a change in status.

[0150] According to one implementation, if a gas port is not properly connected, the corresponding port indicator light can change to a warning color (e.g., red) to indicate that there is currently no gas delivery to that port. This may result in the detection of reverse airflow, for example by a corresponding mass flow controller, flow sensor, or pressure sensor (e.g., by detecting a change in pressure from positive to negative). If gas port 3 is not properly connected, text area 20 may also display a warning banner, such as “Airbag Flow Reversal.” Similarly, color can be used to highlight this warning.

[0151] According to one embodiment, System 1 can be used with a NO generation and delivery system capable of generating NO from indoor air. The NO generation system can be a plasma-based generation system, such as the LungFit® system. The plasma-based NO generation system generates NO from indoor air and delivers it to the breathing circuit of a mechanical ventilator at a controlled concentration (e.g., 0.1 to 500 ppm NO). An attached NO delivery module (NDM) measures the gas flow rate within the ventilator breathing circuit and delivers a controlled flow rate of NO-rich gas to the breathing circuit. The device also integrates a gas monitoring system (with user-defined alarms) for immediate measurement of the concentrations of NO, nitrogen dioxide (NO2), and oxygen (O2) in the ventilator breathing circuit via a gas sampling line before the patient inhales.

[0152] The plasma-based system can consist of three subsystems: an NO generator with an NO2 filter; a NO backup and gasbag system; and a gas sampling and monitoring system. The NO generator subsystem utilizes O2 and nitrogen (N2) from ambient air to generate NO. Ambient air (containing approximately 21% O2 and 79% N2) for NO generation is pumped into the device. This air passes through a particulate filter (to remove dust particles) and then enters a flow meter that measures the airflow rate. Both the pump and the flow meter are connected to a microcontroller that ensures the required airflow rate through the NO plasma chamber. In other embodiments, a mass flow controller can be used instead of the pump and flow meter. An NO2 filter is located at the outlet of the NO generator. Its function is to remove NO2 from the NO-containing gas flow before it is delivered to the ventilation circuit. Electronic circuitry in each filter is used to record filter usage, ensuring that it is not depleted from previous use. A 1μm filter can be located at both the filter inlet and the NO2 filter outlet. A single filter can provide NO2 filtration for a predetermined time, regardless of NO concentration and ventilation settings. The NDM (Near-Diffusion Meter) measures the gas flow rate in the ventilator breathing circuit (flow sensor) and delivers a NO gas mixture to the inspiratory branch of the ventilator breathing circuit (syringe line and adapter). The NDM can be placed near the ventilator gas outlet to allow the NO-rich gas from the NDM to mix properly with the gas flow delivered by the ventilator. The gas sampling system includes a gas monitoring module with an alarm to measure and monitor the concentrations of NO, NO2, and O2 in the ventilator circuit. This is accomplished by sampling the gas flow in the inspiratory branch of the ventilator breathing circuit near the patient connection. One end of the gas sampling line is connected to the inspiratory branch of the ventilator breathing circuit near the patient connection, and the other end is connected to the gas sampling port. A gas pump draws gas from the ventilator breathing circuit. The gas sampling line may include a hydrophobic filter and tubing based on synthetic polymers (e.g., fluoropolymer-polymer copolymers based on sulfonated tetrafluoroethylene). The integrated backup NO delivery system is a completely independent backup NO generation system, separate from the main delivery system; this system has its own NO generator and gas flow delivery system. A backup NO delivery system is typically used in case the primary NO delivery system fails. The backup NO delivery system can also deliver NO to the cuff system connector. The cuff system connector has two tubing connections: one for connecting to an air / oxygen source via an oxygen line or equivalent to provide an external air / oxygen flow; the other for connecting to a manual resuscitator for manual ventilation of the patient. Flow from the backup NO module is added to this air / oxygen flow, thereby diluting the NO concentration to a therapeutic level. The final NO concentration will depend on the amount of external airflow added.

[0153] Plasma-based systems can generate NO from ambient air using pulsed plasma or discharge. For example, U.S. Patent No. 9,573,110 to Montgomery et al. describes a plasma-based system, which is incorporated herein by reference and described in more detail below.

[0154] In the following detailed description, the term "air" will be used to broadly describe the oxygen and nitrogen mixture used to generate NO in the plasma chamber, but also to refer to other gas mixtures containing oxygen and nitrogen that may be generated by alternative gas sources (such as gas containers commonly used in anesthesia machines, which may contain different concentrations).

[0155] The plasma-based system includes a plasma chamber comprising: a gas inlet for allowing an airflow or other gas containing oxygen and nitrogen to enter the plasma chamber; two electrodes separated by a gap; an electronic control circuit connected to the electrodes for generating a discharge at both ends of the gap to produce NO; and an outlet for allowing the NO-containing gas mixture to exit the chamber.

[0156] Plasma-based systems generate NO in precisely controlled amounts over a wide range of gas flow rates and NO concentrations by controlling one or both of the pulse frequency (number of complete discharges per second) and / or pulse duration (duration of each complete discharge) of the electrical pulse discharge across the electrode gap. The amount of NO generated is directly proportional to both the frequency and duration of the electrical pulse discharge; therefore, controlling either one alone or in combination provides a wide range of NO generation control.

[0157] The electronic control circuitry begins each discharge pulse with a brief high-voltage phase to initially ionize the gas and allow current to begin flowing through the electrode gap, followed by a second phase of the pulse with lower voltage and current. The first high-voltage phase of the pulse can be maintained for a very short time, just enough to initially ionize the gas between the electrodes and allow current to flow in the electrode gap. In the second phase of the pulse, the voltage and current can be reduced to lower values, corresponding to the adjustable duration phase of the electrical pulse discharge. The device is designed so that most NO is generated in the more efficient second phase. Several stable combinations of voltage and current can be used in this second phase, each with its own advantages and disadvantages. This type of discharge, characterized by intermittent pulse operation with controlled frequency and / or duration under controlled conditions, primarily at low current, offers benefits including:

[0158] It efficiently generates NO by producing only the amount required for the application, without the need for additional dilution gases. Its NO generation does not significantly raise the temperature of the gases entering the biological system, thus eliminating the need for cooling devices. Due to its low average current, it significantly reduces electrode wear caused by electrode vaporization. Low current and intermittent pulsed discharge efficiently generate NO without producing high levels of NO2.

[0159] Another desirable feature of plasma-based systems is the more efficient generation of NO with lower power consumption. One way to improve NO generation efficiency is to provide a magnetic field at both ends of the electrode gap. This can be achieved by using electromagnetic coils or permanent magnets to provide the magnetic field at both ends of the electrode gap. With the magnetic field passing perpendicularly through the gap, the amount of NO generated can be increased by up to 45% for the same discharge pulse setting. Specific examples of improving efficiency will be described in the Detailed Description of the Invention section.

[0160] Figure 3 A plasma chamber 101 is shown, having a reactor housing 102 with a reactor gas inlet port 108 and a first electrode 112 on one side, and a reactor gas outlet port 110 and a second electrode 120 on the other side. If the chamber housing is made of a conductive material, the electrodes can be insulated with non-conductive materials 114 and 122. The electrodes may have electrode tips 116 and 124 made of a material that is resistant to high temperatures and does not easily vaporize, oxidize, or abrade. The materials used for the electrode tips can be selected from the noble metal groups of the periodic table, including tungsten and platinum. The electrodes are connected to an electronic control circuit via insulated cables 118 and 126.

[0161] In one embodiment of the system, the plasma chamber may have magnets 130 and 132 located on the reactor housing 102 such that they are close to the air gap between electrodes 112 and 120, each magnet facing the chamber with opposite magnetic poles, thereby enhancing the magnetic field across the air gap. One embodiment of the invention has one magnet on each side of the air gap, although a single, stronger magnet applying the same magnetic field strength at both ends of the air gap would also be suitable. It is believed that the magnetic field across the air gap causes the discharge to disperse within the air gap, resulting in a larger plasma cross-sectional area and more efficient NO generation. In one embodiment, the magnets are rare-earth magnets made of neodymium, iron, and boron.

[0162] The reactor housing 102 may be provided with a port 134 that allows the photodiode 138 to have optical communication with the interior of the plasma chamber 101. This optical communication allows the photodiode to be directly mounted on the port 134 of the reactor housing; or more preferably, an optical fiber cable 136 is installed to the port of the plasma chamber and then connected to the photodiode, thereby keeping the photodiode away from the plasma chamber and from electrical interference caused by pulsed discharges. The photodiode 138 provides a signal proportional to the light energy falling on its active surface. When a pulsed discharge occurs, light is generated in the ionized plasma, and the photodiode detects this light. As long as the discharge is in progress, the light signal from the photodiode appears at the same frequency and pulse duration as the discharge.

[0163] Figure 4This is a schematic diagram of a NO generator. The NO generator mainly consists of three subsystems: a NO generator unit 150, an outlet filter assembly 178, and a NO applicator 184. The NO generator unit is where a controlled amount of NO is generated and delivered to the generator gas outlet port 176. The generator unit 150 has a main electronic control circuit 160, which is connected to the main electrical components of the system and provides main system control functions. In one embodiment of the invention, this is a microprocessor-based control circuit that executes a stored program stored in a non-transitory medium; however, this is not intended to limit the invention to microprocessor-based control circuits; analog circuits are equally applicable. Connected to the electronic control circuit is a main user control, including an input setting unit 152, a visual display unit 154, a visual alarm indicator 156, and an audible alarm 158. These components provide the main control with the required settings, display any pre-programmed settings that may have been automatically set from the pre-programmed filter memory, and provide audible and visual alarms in case of malfunction. The main components in contact with the air flowing through the device are: generator gas inlet 162, where air is drawn into the unit; inlet filter 164, used to filter the air and remove any unwanted contaminants; and air pump 166, used to draw air in from gas inlet port 162 and regulate the air flow through plasma chamber 101 under the control of electronic control circuit 160. If air pump 166 provides uncalibrated gas flow control, gas flow meter 170 can be used to provide accurate gas flow indication to electronic control circuit 160, allowing electronic control circuit 160 to finely adjust the pump until the gas flow reaches the desired set value. If air pump 166 provides oscillating gas flow output (e.g., in the case of a piston pump), damping chamber 168 can be configured to smooth the oscillations. The gas flow then passes through plasma chamber 101, where electronic control circuit 160 controls the discharge frequency and duration of transelectrodes 112 and 120, thereby generating NO in the air passing through the chamber. Gas exiting plasma chamber 101 passes through a second flow meter 172, which the electronic control circuit uses to independently check the flow rate through the plasma chamber. If the gas pump 166 malfunctions (indicated by zero flow), or if either the first flow meter 170 or 172 malfunctions (indicated by the difference in readings between flow meters 170 and 172), resulting in incorrect airflow through the plasma chamber, the electronic control circuit can activate a visual and / or audible alarm to alert the user to the fault. To detect a malfunction in the discharge circuit, a photodiode 138 and / or electrode current and / or voltage sensing circuit 161 connected to the electronic control circuit 160 are provided to determine whether the correct frequency and pulse duration have been reached. An optional pressure trigger sensor 174 is connected to the gas flow duct 173 after the outlet gas flow meter 172.Electronic control circuitry 160 can utilize the pressure-triggered sensor 174 to control NO delivery as a push (when the pressure-triggered sensor is activated), rather than delivery at a known concentration in a continuous airflow. Different delivery modes will be described in more detail later in this specification. The airflow continues through pressure-triggered sensor 174 to gas outlet port 176, where it connects to outlet filter assembly 178, and is discharged through NO applicator 184, where it is applied to biological system 192.

[0164] The outlet filter assembly 178 has an inlet filter port 180 (connected to the gas outlet port of the NO generator unit 150), a chamber for accommodating impurity filter material 182, and an outlet port 186 (connected to the NO applicator 184). Impurity filter materials include, for example, soda lime, activated carbon, activated alumina, and silica gel impregnated with ascorbic acid. These materials, as well as other materials known in the art, can be used to remove NO2 from NO-containing gases without substantially altering the NO level.

[0165] Such materials may have a fixed capacity to remove or convert NO2 before their effectiveness is exhausted, thus requiring replacement after a period of use. The size of the filter and the amount of NO2 it is exposed to affect its service life before replacement is needed. Filter assembly 78 also includes a readable programmable memory 190, which is connected to the NO generator unit via a filter electrical connector 188. The other end of connector 188 is connected to electronic control circuitry 160, which can read and reprogram the readable programmable memory 190 as the filter is consumed. One implementation of the readable programmable memory is an EEPROM equipped with a serial interface for reading and programming the memory. An alternative implementation is that each individual EEPROM (and thus each filter assembly) contains its own unique identifier in a small amount of read-only memory (ROM). An example of such memory is Microchip Technology's part number 24AA02E48T, a 2KBIT EEPROM where each memory chip has its own MAC address, which is permanently programmed into a small portion of the read-only memory. This EEPROM, which programs its unique identifier into the ROM, means that no two filter components will have the same identifier, and that identifier cannot be updated during use (unlike data in the EEPROM memory). This provides additional protection against the reuse of obsolete filters, as individual identifiers can be stored in a NO generator when they are used, which then prevents filters with the same identifier from being used in the future, for example, if the EEPROM is improperly modified due to corrupted data. An alternative implementation is to use a microcontroller with embedded EEPROM and FLASH memory, instead of just using serial memory devices. The advantage of this implementation is that memory reprogramming can be performed locally by the microcontroller, reducing the processing overhead of the electronic control circuitry 160. An example of such a microcontroller is the Atmel ATtiny25 / 45 / 85.

[0166] Typically, the EEPROM can store usage information acquired from the electronic control circuit 160, revealing the historical concentration of NO being generated, and thus indicating the potential depletion rate of the filter 182. Therefore, when the filter 182 is used for high NO concentrations and / or high flow rates, this will be recorded, and the user will be instructed to replace the filter more frequently than when the filter 182 is used for low NO concentrations and / or low flow rate applications. This depletion information can be derived from the concentration values ​​determined by the electronic control circuit 160 and the flow rates determined by the flow sensors 172 and 170. The EEPROM may also include a proprietary code indicating that it is an authorized device to prevent devices that may not be able to provide the required filtration from deceiving the device. The proprietary code may, for example, use any number of techniques, including public-key encryption to prevent easy copying and forgery of the code.

[0167] Figure 5A schematic diagram of a discharge drive circuit as part of electronic control circuitry 160 is shown. This represents one implementation of the drive circuit, and those skilled in the art will understand that other circuits capable of achieving the same function are possible. To establish the high voltage required for initial ionization of air between electrodes 112 and 120, capacitor discharge circuit 116 discharges through transformer 118 when triggered by pulse trigger controller 114. This results in a high voltage on the other side of transformer 118 sufficient to cause dielectric breakdown and ionize the gas, initiating a current flow through electrodes 112 and 120. The duration of the discharge pulse is maintained by a second circuit powered by high-voltage DC power supply 1100. In cases of high instantaneous current consumption, DC power supply 1100 is buffered by capacitor 1102 to smooth any high current fluctuations. The switching of DC voltage and current is controlled by transistor 1104, which is controlled by pulse duration control circuit 1112, which controls the pulse duration by controlling the on-time of the transistor. The driving circuit functions as follows: Electronic control circuit 160 calculates the required discharge frequency and pulse duration to generate the desired amount of NO. It then triggers each discharge via pulse trigger controller 1114, resulting in a rapid high-voltage pulse from transformer 1118. Simultaneously, electronic control circuit 160 turns on transistor 1104 for the required pulse duration via pulse duration control circuit 1112. The pulse discharge voltage generated across the electrodes is the initial high-voltage spike required to ionize the gas between the electrodes, followed by the lower voltage and current required to maintain the desired pulse duration. If pulse duration control circuit 1112 operates in pulse width modulation (PWM) mode during the conduction phase of the pulse discharge, the actual voltage and current can be controlled by electronic control circuit 1160. With this PWM mode, inductor 1108 is required to smooth the modulated current during the discharge pulse. Interface circuit 1110 connects the two control circuits before applying the discharge voltage to the electrodes. This interface circuit 1110 preferably uses a high-voltage diode to prevent high-voltage spikes from the pulse transformer from damaging transistor 1104. Diode 1106 provides an additional mechanism to ground any high-voltage spikes or negative transients exceeding its breakdown voltage, preventing them from reaching the pulse duration control circuit 1112. This circuit offers significant flexibility not only in controlling the pulse frequency and pulse duration but also in controlling the voltage and current levels during the discharge pulse duration phase. This allows the electronic control circuitry to optimize the discharge frequency and pulse duration settings to minimize the discharge current while maximizing the effectiveness of generating the desired amount of NO, thereby reducing gas temperature and electrode wear.

[0168] Figure 6This is a schematic diagram of a nitric oxide generator according to another embodiment of the present invention, showing the components of the system and their electrical and pneumatic connections. As shown, the NO generator unit 151 may include a gas inlet port 162, an inlet filter 164, a gas pump 166, a mass flow controller 171 (including flow sensors 171a and valves 171b), pressure sensors 163 and 165, a plasma chamber 101, a gas outlet port 176, an electronic control circuit 160, port indicator lights 2a, 3a, and 4a, a graphical user interface 7 / visual display unit 154, a light bar 7b / visual alarm indicator 156, and a speaker 7c / audible alarm 158. The NO generator 151 operates as follows. First, the gas pump 166 draws in air through the gas inlet port 162, and then the air is filtered by the inlet filter 164. The filtered air is then delivered to the mass flow controller 171, which may optionally be configured between pressure sensors 163 and 165. According to one embodiment, the mass flow controller 171 can control the airflow rate through the plasma chamber 101, thereby controlling the flow rate of the generated NO gas through the gas outlet port 176. Furthermore, by controlling the flow rate of the NO gas through the gas outlet port 176, the mass flow controller 171 can also control the final concentration of the output NO gas. Therefore, the flow rate provided by the mass flow controller 171 can be used to determine and confirm the concentration of the output NO gas. This information can be used by the electronic control circuit 160 to determine: (i) whether any of the port indicator lights 2a, 3a, and 4a should be illuminated, and what color they should display; (ii) whether any alarms or other information should be displayed on the user interface 7 or the visual display unit 154; and (iii) whether the light bar 7b or the visual alarm indicator 156 should be illuminated, and what color it should display.

[0169] According to one embodiment, pressure sensors 163 and 165 can be used to track pressures upstream and downstream of pressure sensors 163 and 165, respectively. For example, pressure sensor 163 can be used in conjunction with air pump 166 to maintain a specific pressure, such as 20-30 psig, upstream of mass flow controller 171. Furthermore, pressure sensor 165 can indicate: (i) the pressure at which plasma chamber 101 operates; and (ii) the type of applicator 184 currently in use, such as high-pressure (high-frequency ventilation) or low-pressure (mechanical ventilation).

[0170] According to one embodiment, the NO generator unit 151 may also include a ballast (not shown) between the air pump 166 and the mass flow controller 171. In this respect, the ballast can be used to stabilize the pressure during the operation of the mass flow controller 171, for example, during periods when flow demand reaches its peak.

[0171] Figure 7A This is a schematic diagram of a nitric oxide generation system including two nitric oxide generators according to one embodiment of the present invention. As shown, the nitric oxide generation system 301 includes a first subsystem 310 for generating NO, a second subsystem 320 for generating NO, an electronic control circuit 160, port indicator lights 2a, 3a, and 4a, a graphical user interface 7 / visual display unit 154, a light strip 7b / visual alarm indicator 156, a speaker 7c / audible alarm 158, a valve 275, gas outlet ports 176 and 276, an airbag gas inlet port 277, a filter 178, an NO delivery module (NDM) 187, a breathing device 189 (e.g., a mechanical ventilator, a high-frequency ventilator, or a high-flow nasal cannula), a gas sampling line 193, and a gas sampling system 400. According to one embodiment, solid lines between components represent pneumatic connections, while dashed lines represent electrical connections.

[0172] According to one embodiment, the first subsystem 310 may include a gas inlet port 162, an inlet filter 164, a gas pump 166, a mass flow controller 171 (including a flow sensor 171a and a valve 171b), pressure sensors 163 and 165, and a plasma chamber 101. According to another embodiment, the first subsystem 310 may also include a buffer (not shown) between the gas pump 166 and the mass flow controller 171.

[0173] According to one embodiment, the second subsystem 320 may include a gas inlet port 262, an inlet filter 264, a gas pump 266, a flow sensor 171, and a plasma chamber 101.

[0174] According to one embodiment, valve 275 may be a three-way valve. In this respect, valve 275 may be used to direct NO gas generated from either the first subsystem 310 or the second subsystem 320 to gas outlet port 176 or gas outlet port 276. Thus, valve 275 may be used to switch between four different gas delivery modes: (1) main NO delivery mode; (2) airbag NO delivery mode; (3) main NO and airbag delivery mode; and (4) standby NO delivery mode.

[0175] According to one implementation, in the main NO delivery mode, valve 275 is closed, and only the first subsystem 310 is active. Therefore, the NO gas generated by the first subsystem 310 is delivered to the gas outlet port 176 for the treatment of the patient 192.

[0176] According to one embodiment, in the bag NO delivery mode, valve 275 is configured to receive only NO gas generated by the second subsystem 320 and gas from an air / oxygen source through the bag gas inlet port 277. Valve 275 then delivers the NO / air / oxygen mixture to the gas outlet port 276, which can be connected to a manual resuscitator, such as a portable resuscitation bag.

[0177] According to one embodiment, in the main NO and airbag delivery mode, valve 275 is configured such that (i) NO gas generated by the first subsystem 310 is delivered to gas outlet port 176; and (ii) a mixture of NO gas generated by the second subsystem 320 and air / oxygen from airbag gas inlet port 277 is delivered to gas outlet port 276.

[0178] Finally, in the standby NO delivery mode, valve 275 is configured to receive only the NO gas generated by the second subsystem 320 and deliver it to the gas outlet port 176. According to one embodiment, the standby NO delivery mode can be automatically triggered. In this regard, the standby NO delivery mode can be triggered upon detection of an interruption in the first subsystem 310. This interruption could be due to the complete or partial cessation of NO gas generation in the plasma chamber 101. The interruption could also be caused by excessive NO gas generation in the plasma chamber 101. According to one embodiment, the NO gas generated by the second subsystem 320 can be based on the airflow rate associated with the mass flow controller 171. In this regard, the airflow rate can be historical average airflow rate data calculated from historical flow rate data tracked over a specific time period (e.g., 1 second to 5 minutes). According to one embodiment, the NO gas generated by the second subsystem 320 can be delivered at a fixed or variable concentration.

[0179] According to one embodiment, the first subsystem 310 and the second subsystem 320 may use more than one of the same components during one or more of the above-described gas delivery modes. For example, instead of using separate gas inlet ports 162 and 262, only one gas inlet port may be used.

[0180] According to one embodiment, NO gas output through gas outlet port 176 is filtered through filter 178 and then delivered to NDM 187. NDM 187 is connected to (i) the inspiratory branch of the patient Y-connector for patient 192 and (ii) a breathing device 189, which is also connected to the expiratory branch of the patient Y-connector, thereby creating a breathing circuit for patient 192.

[0181] According to one embodiment, the gas sampling line 193 can also be connected to the inhalation branch of the patient's Y-connector to deliver the mixed gas to the gas sampling system 400, which measures NO, NO2, and O2 in the mixed gas immediately before the patient inhales. The gas sampling system 400 can then provide this measurement information to the electronic control circuitry 160 so that it can subsequently be displayed on the graphical user interface 7 or the visual display unit 154.

[0182] Figure 7B This is according to one embodiment of the present invention. Figure 7A A schematic diagram of the NDM is depicted. As shown, the NDM187 includes an NO gas inlet port 187a, a breathing gas inlet port 187b, a flow sensor 187c, and a mixed gas outlet port 187d. According to one embodiment, the NO gas inlet port 187a is configured to receive filtered NO gas from a filter 178; the breathing gas inlet port 187b is configured to receive breathing gas from a breathing device 189; the flow sensor 187c is configured to sense the breathing gas flow rate from the breathing device 189; and the mixed gas outlet port 187d is configured to provide a mixed flow of breathing gas and NO to the patient 192. According to one embodiment, the flow sensor 187c can transmit the sensed breathing gas flow rate data to an electronic control circuit 160. Subsequently, the electronic control circuit 160 can use the sensed respiratory flow data to determine: (i) whether any of the port indicator lights 2a, 3a, and 4a should be illuminated, and what color they should display; (ii) whether any alarms or other information should be displayed on the user interface 7 or visual display unit 154; and (iii) whether the light bar 7b or visual alarm indicator 156 should be illuminated, and what color it should display. For example, this information could indicate whether the flow sensor 187c is malfunctioning, thereby requiring system 301 to operate in standby NO delivery mode.

[0183] Figure 8 This is a schematic diagram of a gas sampling system according to an embodiment of the present invention. As shown, the gas sampling system 400 includes a gas inlet 401, a gas outlet 401b, a pressure relief system 402, a calibration system 403, a pump 404, a gas sensor 405, a flow sensor 406, and a processor 407.

[0184] According to one embodiment, gas inlet 401 is configured to receive gas sampling line 193. As shown, gas sampling line 193 includes a filter 193a and is in fluid communication with the inspiratory branch of a patient Y-connector. According to one embodiment, filter 193a removes particulate matter from gas sampling line 193.

[0185] According to one embodiment, the pressure relief system 402 includes a filter 402a and a valve 402b. According to one embodiment, the valve 402b may be a bypass valve. In this respect, the valve 402b is capable of releasing any pressure exceeding a predetermined threshold or releasing pressure that causes a change from negative pressure to positive pressure. In this respect, the bypass valve may include a spring-loaded mechanism that is actuated if the pressure across the valve exceeds the predetermined threshold or causes a change from negative pressure to positive pressure. Here, the spring-loaded mechanism may be configured to trigger when (i) the pressure exceeds, for example, 0.01 psig to 1.0 psig; or (ii) positive pressure is detected. According to another embodiment, the valve 402b is connected to a processor 407 and is actuated when it is determined that a parameter associated with the pump 404 is below a specific threshold. According to one embodiment, the pump 404 parameters are one of vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM% pump control, and pump motor speed. According to another embodiment, the valve 402b may be actuated when the processor 407 determines that a flow parameter associated with a medical gas exceeds a specific threshold. In this regard, the flow parameter can be determined by the flow sensor 406. According to one embodiment, the flow parameter can be the flow rate. In this regard, valve 402b can be actuated if the flow rate of the medical gas exceeds, for example, 20% of the target flow rate (e.g., 140 mL / min) of the medical gas being drawn from the gas sampling line. According to one embodiment, filter 402a is configured to protect the forward flow performance of valve 402b and other downstream components from contamination. Filter 402a can be a polypropylene fiber filter. According to one embodiment, pressure relief system 402 is in fluid communication with gas sampling line 193.

[0186] According to one embodiment, the calibration system 403 may include a valve and a filter (not shown) in fluid communication with indoor air. According to one embodiment, the valve is configured to operate in two modes. In a first mode, the valve is configured to introduce medical gas from the gas sampling line 193 through a pressure relief system 402. In a second mode, the valve is configured to introduce indoor air through the filter in fluid communication with indoor air, thereby allowing calibration of the gas sensor 405 using indoor air. According to one embodiment, the valve may be a solenoid valve. In this regard, the processor 407 may actuate the solenoid valve in the calibration system 403 when the gas sensor 405 requires recalibration.

[0187] According to one embodiment, pump 404 is configured to draw medical gas into gas sampling system 400 through gas sampling line 193.

[0188] According to one embodiment, the gas sensor 405 includes an NO sensor 405a, an NO2 sensor 405b, and an O2 sensor 405c. In this regard, the NO sensor 405a, NO2 sensor 405b, and O2 sensor 405c are configured to sense and report the NO concentration, NO2 concentration, and O2 concentration sampled from the inhalation branch via the gas sampling line 193, respectively.

[0189] According to one embodiment, the flow sensor 406 is configured to sense the flow rate of the sampled medical gas.

[0190] According to one embodiment, processor 407 may be a microprocessor-based control circuit that executes a stored program stored in a non-transitory medium, but this is not intended to limit the invention to microprocessor-based control circuits; analog circuits are equally applicable.

[0191] According to another embodiment, the gas sampling system 400 may include a pressure sensor (not shown) located upstream of the pump 404. In this regard, the pressure sensor is configured to sense pressure parameters in the sampled medical gas. For example, the pressure sensor may sense whether the medical gas changes from negative pressure to positive pressure relative to atmospheric pressure. According to one embodiment, the sensed pressure information may be used by the processor 407 to actuate a valve in the pressure relief system 402.

[0192] As shown in the figure, the processor 407 can be electrically connected to the pressure relief system 402, the calibration system 403, the pump 404, the gas sensor 405, and the flow sensor 406, and thus receive data from these components and control them.

[0193] For the pressure relief system 402, if excessive pressure is determined to exist within the gas sampling system 400, the processor 407 can actuate the valve 402b. In this regard, during normal operation of the gas sampling system 400, the pump 404 draws medical gas from the gas sampling line 193, thereby creating a negative pressure environment within the gas sampling system 400. However, certain high-pressure therapies (e.g., therapies using high-flow nasal cannulas or high-frequency ventilators) can cause an increase in positive pressure in the gas sampling line 193 and thus within the gas sampling system 400. This increase in positive pressure can affect the accuracy of monitoring by the gas sampling system 400 and should be corrected as soon as possible. According to one embodiment, the increase in positive pressure can be detected by (i) the pump 404, (ii) the flow sensor 406, or a pressure sensor. For the pump 404, any increase in positive pressure will result in a decrease in the suction of the pump 404. Therefore, certain parameters associated with the pump 404, such as vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM% pump control, or pump motor speed, will also decrease. In this regard, if one of these parameters drops below a certain threshold, processor 407 can actuate valve 402b to release excess pressure through gas outlet 401b. For flow sensor 406, any increase in positive pressure will result in an increase in a specific flow parameter (e.g., flow rate). In this regard, if the flow rate exceeds a certain threshold (e.g., 140 mL / min) by a certain percentage, processor 407 can actuate valve 402b to release excess pressure through gas outlet 401b. For pressure sensor, if the pressure sensor detects a change from negative pressure to positive pressure, processor can actuate valve 402b. According to another embodiment, valve 402b can be a bypass valve and release any pressure exceeding a predetermined threshold without being actuated by processor 407.

[0194] For pump 404, processor 407 can also monitor relevant parameters, such as vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM% pump control, or pump motor speed, to determine the functional life of gas sampling line 193. The "functional life" of gas sampling line 193 refers to the period of time the line remains usable. According to one embodiment, flow resistance can be a convenient indicator of the functional life of gas sampling line 193, as flow resistance increases with use, and the functional life of the line decreases accordingly. In this regard, flow resistance may increase as filter 193a removes particulate matter from gas sampling line 193. Increased flow resistance requires pump 404 to increase vacuum pump power to maintain a constant flow rate. Therefore, increases or decreases in specific pump parameters can be used to indicate the functional life of gas sampling line 193 in real time. This information can be transmitted from processor 407 to electronic control circuitry 160, and then displayed to the user in a graphical user interface, such as the gas sampling line status area 13 in user interface layout 10 (see...). Figure 9This is illustrated in the portion of the user interface layout 10 that focuses on the gas sampling line status area 13. In this regard, as the working pneumatic load increases over time, the dynamic bar graph 13a will "fill," indicating its current working load status. Before reaching the pump's full working vacuum, experiencing a loss in gas sampling flow rate, or a change in monitoring accuracy, an indicator (e.g., a first visual indicator 13b) can indicate to the user, for example, that the gas sampling line 193 should be replaced as soon as possible by reaching a second visual indicator 13c. As the pump load increases, the first visual indicator will decrease proportionally, indicating the depletion of filter life in real time. When the functional life of the gas sampling line 193 approaches the time when it needs replacement, the visual display can show that the first visual indicator 13b approaches or crosses the second visual indicator 13c. Allowing the gas sampling line 193 to continue operating beyond this point can lead to gas sampling line failure and a corresponding emergency machine alarm. According to another embodiment, in addition to using bar graph 13a, the functional life of the gas sampling line 193 can also be expressed as a percentage, an integer, etc. For example, when gas sampling line 193 is first replaced (time = 0), the flow resistance will be at its lowest, so the functional life can be considered 100%. As the flow resistance increases, this percentage will decrease proportionally. According to one embodiment, the visual representation of functional life (e.g., bar chart 13a, percentage, etc.) can be scaled and calibrated based on pump control inputs to provide proportional user feedback. In this regard, when the gas sampling line is replaced, the displayed chart 13a will be recalibrated based on at least one parameter related to the gas sampling pump and the new gas sampling line (e.g., vacuum pressure (mmHg), vacuum pump power, pump input current, pump voltage, PWM% pump control, or pump motor speed (e.g., measured by a tachometer)). This can be performed automatically or manually. For example, chart 13a can be automatically scaled and recalibrated by: (i) detecting at least one pump parameter; (ii) comparing the detected pump parameter to a target value; and (iii) recalibrating bar chart 13a back to 100% when it is determined that the pump parameter has reached the target value. Furthermore, Figure 13a can be manually scaled and recalibrated by inputting specific values ​​via user interface layout 10. For example, the user can press the gas sampling line symbol key (shown here as a circle with an S and an arrow) to initiate manual recalibration.

[0195] For gas sensor 405, processor 407 can monitor real-time NO, NO2 and O2 concentrations and transmit them to electronic control circuit 160 so that they can be displayed on user interface layout 10, for example by displaying the measured NO concentration area 16, the measured NO2 concentration area 17 and the measured O2 concentration area 18.

[0196] Figure 10AThis is a schematic diagram of the bottom casing of a nitric oxide delivery system according to an embodiment of the present invention. Figure 10B A side view of the bottom casing is shown. Figure 10C A cross-sectional view of the bottom housing is shown. As shown, the bottom housing of system 1 includes a plurality of inclined recesses 31 disposed along a first portion, and a mounting bracket 32 ​​located in a second portion. According to one embodiment, the inclined recesses 31 are configured to receive at least one external plunger 41a associated with the transfer device 40. In this respect, the at least one external plunger 41a may be located on the mounting bracket 41 connected to the transfer device 40. According to one embodiment, the at least one external plunger 41a may be located on either side of the mounting bracket 41 and configured to engage with the inclined recesses 31. According to one embodiment, the inclined recesses 31 are configured to gradually depress the external plunger 41a as it moves proximally along the first portion of the bottom housing. Once partially or fully depressed, the external plunger 41a may then move along the mounting bracket 32 ​​until it engages with a receiving portion 32a, which is configured to receive the external plunger 41a. According to one embodiment, the external plunger 41a may be spring-loaded. In addition, according to one embodiment, the transfer device 40 may be a trolley or a wheeled system (such as a hospital bed).

[0197] According to one embodiment, the gas sampling system 400 can be used with any NO source, including a container for storing NO and any NO generator. In this regard, the NO source can be provided via NDM 187. According to one embodiment, the NO generator can generate NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3). In this regard, the NO generator can generate NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, as described above with respect to plasma-based generation systems (e.g., NO generators 101, 201). NO can also be generated by heating liquid N2O4, which produces NO2, which can then be converted into NO gas by an antioxidant (e.g., ascorbic acid, α-tocopherol, and / or γ-tocopherol). Furthermore, NO gas can also be generated by the reaction between HNO3 and gaseous sulfur dioxide (SO2).

[0198] Although the invention has been specifically shown and described with reference to its preferred embodiments, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the scope of the invention as covered by the appended claims.

Claims

1. A nitric oxide gas delivery system, the system comprising: At least one nitric oxide (NO) gas generator to generate NO gas; Multiple port indicator lights surrounding multiple corresponding gas ports, wherein each of the port indicator lights is configured to display a color; and An electronic control circuit, wherein the electronic control circuit is configured to enable the plurality of port indicator lights to display the color based on: (i) the status of the at least one NO gas generator, and (ii) the flow rate of NO gas delivered through the respective gas port.

2. The system according to claim 1, wherein, The multiple port indicator lights illuminate when the corresponding gas port is activated.

3. The system according to claim 1 or 2, wherein, The color displayed by the port indicator light indicates whether NO gas of a set concentration is being delivered through the corresponding gas port.

4. The system according to claim 3, wherein, The plurality of port indicator lights are configured to: (i) display a first color if NO gas is being delivered through the corresponding gas port at the set concentration; (ii) display a second color if NO gas is being delivered through the corresponding gas port at a concentration different from the set concentration; and (iii) display a third color if no NO gas is being delivered through the corresponding gas port.

5. The system according to any one of claims 1 to 4, wherein, At least one of the corresponding gas ports is a gas outlet.

6. The system according to claim 5, wherein, The gas outlet is selected from the NO delivery outlet or the manual resuscitation airbag outlet.

7. The system according to any one of claims 1 to 6, wherein, The system also includes two NO gas generators.

8. The system according to claim 7, wherein, The two NO gas generators operate simultaneously.

9. The system according to claim 7, wherein, Only one of the two NO gas generators is operated at a time.

10. The system according to claim 9, wherein, One of the multiple port indicator lights displays a first color during the operation of the first NO gas generator and a second color during the operation of the second NO gas generator.

11. The system according to any one of claims 1 to 10, wherein, The NO gas is generated from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

12. The system according to any one of claims 1 to 11, wherein, The system also includes: A graphical user interface display, wherein the graphical user interface display is configured to display the status of the at least one NO gas generator.

13. The system according to claim 12, wherein, The system also includes a gas sampling line port, the graphical user interface display is configured to display the status of the gas sampling line, and the gas sampling line is configured to connect a breathing circuit to the gas sampling port.

14. The system according to claim 12 or 13, wherein, The graphical user interface is also configured to receive user input for a set concentration of NO gas to be delivered.

15. The system according to any one of claims 12 to 14, wherein, The system also includes light strips configured to display color based on (i) the state of the at least one NO gas generator and (ii) the flow rate of NO gas delivered through the respective gas port.

16. A nitric oxide gas delivery system, the system comprising: A nitric oxide (NO) source, wherein the nitric oxide (NO) source is used to provide NO gas; Multiple port indicator lights surrounding multiple corresponding gas ports, wherein each of the port indicator lights is configured to display a color; and An electronic control circuit, wherein the electronic control circuit is configured to enable the plurality of port indicator lights to display the color based on the flow rate of NO gas delivered through the respective gas port.

17. The system according to claim 16, wherein, The multiple port indicator lights illuminate when the corresponding gas port is activated.

18. The system according to claim 16 or 17, wherein, The color displayed by the port indicator light indicates whether NO gas of a set concentration is being delivered through the corresponding gas port.

19. The system according to claim 18, wherein, The plurality of port indicator lights are configured to: (i) display a first color if NO gas is being delivered through the corresponding gas port at the set concentration; (ii) display a second color if NO gas is being delivered through the corresponding gas port at a concentration different from the set concentration; and (iii) display a third color if no NO gas is being delivered through the corresponding gas port.

20. The system according to any one of claims 16 to 19, wherein, At least one of the plurality of corresponding gas ports is a gas outlet.

21. The system according to claim 20, wherein, The gas outlet is selected from the NO delivery outlet, the manual resuscitation airbag inlet, or the manual resuscitation airbag outlet.

22. The system according to any one of claims 16 to 21, wherein, The NO source is either a container for storing NO or a NO generator.

23. The system according to claim 22, wherein, The NO generator produces NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

24. The system according to claim 22 or 23, wherein, The system also includes: A graphical user interface display, wherein the graphical user interface display is configured to display the status of the NO generator.

25. The system according to claim 24, wherein, The graphical user interface is also configured to receive user input for a set concentration of NO gas to be delivered.

26. A nitric oxide gas delivery system, the system comprising: A first subsystem for generating nitric oxide (NO) gas includes a first NO generator and a mass flow controller, wherein the mass flow controller controls the airflow rate entering the first NO generator. The second NO subsystem is used to generate NO gas, and the second subsystem includes a second NO generator. At least one gas outlet port for conveying NO gas generated by the first subsystem or the second subsystem; and An electronic control circuit configured to select one of the first subsystem and the second subsystem to supply NO gas to the at least one gas outlet port based on the air flow rate associated with the mass flow controller.

27. The nitric oxide gas delivery system according to claim 26, wherein, The air velocity refers to the historical average air velocity associated with the mass flow controller.

28. The nitric oxide gas delivery system according to claim 27, wherein, The historical average air velocity is calculated based on historical air velocity tracked over a period of time.

29. The nitric oxide gas delivery system according to claim 28, wherein, The time period is from 1 second to 5 minutes.

30. The nitric oxide gas delivery system according to any one of claims 26 to 29, wherein, The system also includes an NO delivery module in fluid communication with the at least one gas outlet port, the NO delivery module including a breathing gas flow sensor configured to sense the breathing gas flow rate.

31. The nitric oxide gas delivery system according to claim 30, wherein, The electronic control circuit is configured to select the second subsystem to supply NO gas to the at least one gas outlet port when an interruption in the breathing gas flow rate is detected.

32. The nitric oxide gas delivery system according to claim 31, wherein, The interruption was due to a malfunction in the respiratory gas flow sensor.

33. The nitric oxide gas delivery system according to any one of claims 30 to 32, wherein, The respiratory gas flow rate is provided to the electronic control circuit by the NO delivery module.

34. The nitric oxide gas delivery system according to any one of claims 26 to 33, wherein, The electronic control circuit is configured to select the second subsystem to supply NO gas to the at least one gas outlet port when an interruption is detected in the first subsystem.

35. The nitric oxide gas delivery system according to claim 34, wherein, The interruption is one of the situations in which the first NO generator completely or partially stops generating NO gas.

36. The nitric oxide gas delivery system according to claim 34, wherein, The interruption was caused by the first NO generator generating excessive amounts of NO gas.

37. The nitric oxide gas delivery system according to any one of claims 26 to 36, wherein, The NO gas provided has a fixed or variable concentration.

38. The nitric oxide gas delivery system according to any one of claims 26 to 37, wherein, The first NO gas generator and the second NO gas generator include a plasma chamber, which encapsulates two electrodes separated by a gap.

39. The nitric oxide gas delivery system according to any one of claims 26 to 38, wherein, The first NO gas generator and the second NO gas generator each use liquid nitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3) to generate the NO gas.

40. A method for conveying nitric oxide gas, the method comprising: Nitric oxide (NO) gas is generated using a first subsystem, wherein the first subsystem includes a first NO generator and a mass flow controller, the mass flow controller controlling the air flow rate entering the first NO generator; NO gas is generated using a second subsystem, wherein the second subsystem includes a second NO gas generator, and the NO gas generated by the second subsystem is based on an airflow rate associated with the mass flow controller; and The NO gas generated by the first subsystem or the second subsystem is supplied to at least one gas outlet port.

41. The method according to claim 40, wherein, The air velocity refers to the historical average air velocity associated with the mass flow controller.

42. The method according to claim 40, wherein, The historical average air velocity is calculated based on historical air velocities tracked over a period of time.

43. The method according to claim 42, wherein, The time period is from 1 second to 5 minutes.

44. The method according to any one of claims 40 to 43, wherein, When an interruption in the respiratory gas flow rate is detected, NO gas generated by the second subsystem is supplied to the at least one gas outlet port.

45. The method according to claim 44, wherein, The interruption was due to a malfunction in the respiratory gas flow sensor.

46. ​​The method according to any one of claims 40 to 45, wherein, When an interruption is detected in the first subsystem, NO gas generated by the second subsystem is supplied to the at least one gas outlet port.

47. The method according to claim 46, wherein, The interruption is one of the situations in which the first NO generator completely or partially stops generating NO gas.

48. The method according to claim 46, wherein, The interruption was caused by the first NO generator generating excessive amounts of NO gas.

49. The method according to any one of claims 40 to 48, wherein, The NO gas provided by the first subsystem and / or the second subsystem has a fixed or variable concentration.

50. The method according to any one of claims 40 to 49, wherein, The first NO gas generator and the second NO gas generator include a plasma chamber, which encapsulates two electrodes separated by a gap.

51. The method according to any one of claims 40 to 50, wherein, The first NO gas generator and the second NO gas generator generate the NO gas from liquid nitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2), or nitric acid (HNO3).

52. The nitric oxide gas delivery system according to any one of claims 1 to 15, wherein, The system also includes: A bottom housing, wherein the bottom housing comprises: At least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down the at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and The mounting bracket includes at least one receiving portion for receiving the at least one external plunger.

53. The nitric oxide gas delivery system according to any one of claims 16 to 25, wherein, The system also includes: A bottom housing, wherein the bottom housing comprises: At least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down the at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and The mounting bracket includes at least one receiving portion for receiving the at least one external plunger.

54. The nitric oxide gas delivery system according to any one of claims 26 to 39, wherein, The system also includes: A bottom housing, wherein the bottom housing comprises: At least one inclined recess along a portion of the bottom housing, wherein the at least one inclined recess is configured to press down the at least one external plunger as the at least one external plunger moves proximally along the bottom housing; and The mounting bracket includes at least one receiving portion for receiving the at least one external plunger.

55. A gas sampling system for a medical gas delivery device, the gas sampling system comprising: Gas sampling pipeline; Pump; as well as Pressure relief system The pump is configured to draw medical gas into the gas sampling system through the gas sampling line; the pressure relief system is configured to release excess pressure in the gas sampling system through an outlet.

56. The gas sampling system according to claim 55, wherein, Excess pressure refers to the amount of pressure exceeding a predetermined threshold.

57. The gas sampling system according to claim 56, wherein, The predetermined threshold is 0.01 to 1.0 psig.

58. The gas sampling system according to any one of claims 55 to 57, wherein, The excessive pressure is caused by the positive pressure in the gas sampling line.

59. The gas sampling system according to claim 58, wherein, The positive pressure is generated by a breathing device that is in fluid communication with the gas sampling line.

60. The gas sampling system according to claim 59, wherein, The breathing device is one of a high-flow nasal cannula, a mechanical ventilator, or a high-frequency ventilator.

61. The gas sampling system according to any one of claims 55 to 60, wherein, The pressure relief system includes valves and filters.

62. The gas sampling system according to claim 61, wherein, The valve is a bypass valve, which is configured to release any pressure exceeding the predetermined threshold.

63. The gas sampling system according to claim 61 or 62, wherein, The valve is connected to the processor and is actuated when the pump parameters are determined to be below a certain threshold.

64. The gas sampling system according to claim 63, wherein, The pump parameters are one of the following: vacuum pressure, vacuum pump power, pump input current, pump voltage, pulse width modulation (PWM) pump control, and pump motor speed.

65. The gas sampling system according to claim 61, wherein, The valve is connected to the processor and is actuated when it is determined that the flow parameter related to the medical gas is below a certain threshold, wherein the flow parameter is determined by a flow sensor in fluid communication with the pressure relief system.

66. The gas sampling system according to claim 65, wherein, The flow rate parameter is the flow velocity.

67. The gas sampling system according to any one of claims 61 to 66, wherein, The filter is configured to protect the valve's forward flow performance from contamination.

68. The gas sampling system according to any one of claims 55 to 67, wherein, The pressure relief system is in fluid communication with the gas sampling pipeline.

69. The gas sampling system according to any one of claims 55 to 68, wherein, The medical gas includes nitric oxide (NO) gas.

70. The gas sampling system according to claim 69, wherein, The NO gas is provided by an NO source.

71. The gas sampling system according to claim 70, wherein, The NO source is either a container for storing NO or a NO generator.

72. The gas sampling system according to claim 71, wherein, The NO generator produces NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

73. A gas sampling system for a medical gas delivery device, the gas sampling system comprising: Gas sampling lines including filters; Pump; as well as processor, The pump is configured to draw medical gas into the gas sampling system through the gas sampling line; the processor is configured to: (i) determine input parameters related to the pump required to maintain a constant flow rate in the gas sampling line; and (ii) determine real-time information of the gas sampling line based on the input parameters. (iii) Update the user interface display based on the determined real-time information.

74. The gas sampling system according to claim 73, wherein, The input parameters are selected from one or more of the following: vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM pump control, and pump motor speed.

75. The gas sampling system according to claim 73 or 74, wherein, The real-time information is related to the functional lifespan of the gas sampling pipeline.

76. The gas sampling system according to claim 75, wherein, The real-time information is presented on the user interface display in the form of a bar chart.

77. The gas sampling system according to claim 76, wherein, The bar chart includes a first visual indicator with a first contrasting color above it and a second contrasting color below it, and the first visual indicator decreases as the gas sampling line is used.

78. The gas sampling system according to claim 77, wherein, The bar chart includes a second visual indicator located below the first visual indicator, the second visual indicator corresponding to the alarm threshold.

79. The gas sampling system according to any one of claims 76 to 78, wherein, The bar graph was recalibrated when the gas sampling line was replaced.

80. The gas sampling system according to any one of claims 73 to 79, wherein, The filter removes particulate matter from the gas sampling line.

81. The gas sampling system according to any one of claims 73 to 80, wherein, The medical gas includes nitric oxide (NO) gas.

82. The gas sampling system according to claim 81, wherein, The NO gas is provided by an NO source.

83. The gas sampling system according to claim 82, wherein, The NO source is either a container for storing NO or a NO generator.

84. The gas sampling system according to claim 83, wherein, The NO generator produces NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

85. A method for monitoring real-time information of a gas sampling pipeline in a gas sampling system, the method comprising: Determine the input parameters of the pump required to maintain a constant flow rate in the gas sampling line, wherein the pump draws medical gas into the gas sampling system through the gas sampling line; Based on the input parameters, determine the real-time information of the gas sampling pipeline; and The user interface display is updated based on the determined real-time information.

86. The method according to claim 85, wherein, The input parameters are selected from one or more of the following: vacuum pressure, vacuum pump power, pump input current, pump voltage, PWM pump control, and pump motor speed.

87. The method according to claim 85 or 86, wherein, The determined real-time information is related to the functional lifespan of the gas sampling pipeline.

88. The method according to any one of claims 85 to 87, wherein, The determined real-time information is displayed on the user interface display in the form of a bar graph.

89. The method according to claim 88, wherein, The bar chart includes a first visual indicator with a first contrasting color above it and a second contrasting color below it, and the first visual indicator decreases as the gas sampling line is used.

90. The method according to claim 89, wherein, The bar chart includes a second visual indicator located below the first visual indicator, the second visual indicator corresponding to the alarm threshold.

91. The method according to any one of claims 88 to 90, wherein, The bar graph was recalibrated when the gas sampling line was replaced.

92. The method according to any one of claims 85 to 91, wherein, The medical gas includes nitric oxide (NO) gas.

93. The method according to claim 92, wherein, The NO gas is provided by an NO source.

94. The method according to claim 93, wherein, The NO source is either a container for storing NO or a NO generator.

95. The method according to claim 94, wherein, The NO generator produces NO gas from nitrogen (N2) and oxygen (O2) present in ambient air, liquid dinitrogen tetroxide (N2O4), gaseous nitrogen dioxide (NO2) or nitric acid (HNO3).

Images