Method of operating a system for delivering therapeutic gas into the respiratory gas in the inspiratory limb of a patient's breathing circuit - Patents.com

Abstract

A system and method for delivering therapeutic gas to a patient in need thereof is provided. A patient (108) receives respiratory gas from a high-frequency ventilator (117) using at least enhanced therapeutic gas (e.g., nitric oxide, NO, etc.) flow meters. At least some of these enhanced therapeutic gas flow meters can be used to address several surprising phenomena that sometimes occur when therapeutic gas is turbulently mixed into the respiratory gas received by the patient from a breathing circuit attached to a high-frequency ventilator. When at least some of these enhanced therapeutic gas flow meters are used, the delivery of turbulently mixed therapeutic gas into the respiratory gas received by the patient can be more accurate and / or under-delivery of therapeutic gas into the respiratory gas can be avoided and / or reduced.

Description

[Technical field]

[0001] The present invention generally relates to a medical device that is adapted for use in a medical device, such as a medical device for treating a medical condition, such as a gas-containing medical device, a medical device for treating a medical condition, or a medical device for treating a medical condition. To a patient receiving respiratory gas from a ventilator, an accelerated therapeutic gas (NO) flow meter is used. The present invention relates to a system and method for delivering therapeutic gas. [Background technology]

[0002] Therapeutic gases can be delivered to patients in need thereof to provide medical benefit. One of the therapeutic gases is nitric oxide (NO) gas, which expands blood vessels in the lungs when transmitted through the air. This improves blood oxygenation and reduces pulmonary hypertension. Therefore, nitric oxide can be provided to patients with pulmonary hypertension as a therapeutic gas in the respiratory gas.

[0003] In addition, many patients receive their breathing gas (e.g., inspired breathing gas) from a ventilator. The ventilator may vary at least the pressure and / or flow (e.g., high Unlike traditional ventilators, high-frequency ventilators use a constant inflation and The pressure is measured at a very high rate around the MAP. (For example, up to 900 revolutions per minute) and changes. In other words, high frequency artificial ventilation The device maintains a constant pressure in the patient's breathing circuit, and this pressure oscillates at very high speeds. In practice, this can enhance gas exchange across the blood vessels in the patient's lungs.

[0004] Although high-frequency ventilators are beneficial, patients receiving respiratory gas from a high-frequency ventilator: Further benefits are received from the therapeutic gas. Taking advantage of these further benefits, the therapeutic gas is It is necessary to supply the patient with the respiratory gas received from the breathing circuit attached to the ventilator. However, by supplying therapeutic gas into the patient's breathing gas supplied to the patient from a high-frequency ventilator, These difficulties and / or unexpected problems exist. Unanticipated problems may affect the delivery and / or accuracy of administration of therapeutic gas.

[0005] Thus, at least one ventilator capable of varying pressure and / or flow (e.g. It occurs when delivering therapeutic gas to a patient receiving respiratory gas from a ventilator (such as a high-frequency ventilator). Overcome difficult and / or unexpected problems that may arise and improve the accuracy of therapeutic gas delivery and / or administration. It is necessary to [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Pat. No. 5,558,083 [Patent Document 2] U.S. Patent No. 14 / 672447 Summary of the Invention [Problem to be solved by the invention]

[0007] An embodiment of the present invention is a nitric oxide dispenser that delivers a therapeutic gas containing NO into the inspiratory limb of a breathing circuit. In conjunction with the supply system, the breathing circuit can be equipped with a high-frequency ventilator. The injection system receives a flow of therapeutic gas and injects the therapeutic gas into the delivery circuit. The injection module can include a forward NO flow rate measurement module. A unidirectional NO flow sensor (e.g., going into the injection module, the nitric oxide delivery system) system to the injection module, etc.) and / or forward and reverse NO flow rates. and / or a bidirectional NO flow sensor capable of measuring The flow sensor and / or the flow sensor can be connected to a nitric oxide supply system. Using the information communicated to the system, the nitric oxide delivery system delivers NO to the injection module. more accurately and / or to avoid under-delivery of therapeutic gas into the respiratory gas. and / or may be reduced.

[0008] In an exemplary embodiment, the NO flow sensor comprises at least one of the components found by applicant. This can be used to combat surprising erroneous flow phenomena.

[0009] In an exemplary embodiment, the flow information may be obtained from a bi-directional flow sensor. The information from this bidirectional flow sensor is that at least the pressure and / or flow rate can be changed. and / or can be used to detect the use of mechanical ventilation (e.g., high-frequency ventilators); Or at least, to correct distortions in the flow information generated by the ventilator. Cut.

[0010] In an exemplary embodiment, the flow information may be obtained from a one-way flow sensor. The information from this one-way flow sensor is that at least the pressure and / or flow rate can be changed. and / or can be used to detect the use of mechanical ventilation (e.g., high-frequency ventilators); Or at least, to correct distortions in the flow information generated by the ventilator. Cut. [Brief description of the drawings]

[0011] The features and advantages of the present invention will become more fully apparent from the following detailed description taken in conjunction with the accompanying drawings. can be understood objectively. [Figure 1] 1 illustrates an exemplary nitric oxide delivery system, in accordance with an exemplary embodiment of the present invention. [Diagram 2] 1 illustrates an exemplary nitric oxide delivery system having a check valve in accordance with an exemplary embodiment of the present invention. [Diagram 3] 1 illustrates an exemplary nitric oxide delivery system using an exemplary ventilator having a free-breathing valve, in accordance with an exemplary embodiment of the present invention. [Figure 4A] 1 illustrates an exemplary injection module having a bi-directional NO flow sensor, according to an exemplary embodiment of the present invention. [Figure 4B] 1 illustrates an exemplary injection module having a bi-directional NO flow sensor, according to an exemplary embodiment of the present invention. [Figure 5A] 1 illustrates an exemplary graphical display of information from a flow sensor, according to an exemplary embodiment of the present invention. [Figure 5B] 1 illustrates an exemplary graphical display of information from a flow sensor, according to an exemplary embodiment of the present invention. [Figure 5C] 1 illustrates an exemplary graphical display of information from a flow sensor, according to an exemplary embodiment of the present invention. [Figure 6A] 1 illustrates an example graphical representation of information from a flow sensor including negative flow information and / or negative flow rate, according to an example embodiment of the present invention. [Figure 6B] 1 illustrates an example graphical representation of information from a flow sensor including negative flow information and / or negative flow rate, according to an example embodiment of the present invention. [Figure 6C] 1 illustrates an example graphical representation of information from a flow sensor including negative flow information and / or negative flow rate, according to an example embodiment of the present invention. Detailed Description of the Invention

[0012] The present invention generally relates to a method for providing a therapeutic gas to a patient in need of therapeutic gas and receiving respiratory gas from a ventilator. The present invention relates to a system and method for supplying gas to a ventilator, the ventilator being configured to control at least the pressure and / or flow rate. can be varied (e.g., high-frequency ventilators), among other things, to facilitate therapeutic gases ( For example, nitric oxide (NO) flow meters are used. These facilitate therapeutic gas flow measurements. At least some of these instruments can be used to address some surprising phenomena. These phenomena can sometimes cause changes in the pressure and / or flow of the ventilator. Disturbances in the respiratory gases received by the patient from a breathing circuit (e.g., a high-frequency ventilator) This occurs when the therapeutic gas mixes with the flow. Some and / or uses of the present invention may result in disturbances in the respiratory gases received by the patient from the ventilator. The dosage of the therapeutic gas mixed in the controlled flow may be more accurate and / or the therapeutic gas may be less likely to be delivered into the respiratory gas. This can avoid and / or reduce medical gas supply shortages.

[0013] As used here, "proportional turbulent mixing," "turbulent mixing," and "proportional "Volume mixing" and the like refer to mixing of flows and the adjustable flow associated with turbulent main flows. It is an uncontrollable flow, and the components introduced into the turbulent flow are treated as part of the mainstream. The flow meter is controlled by a suction pump and typically mixes with the mainstream flow upstream (or alternatively downstream) of the flow meter. In some configurations, the inhalation flow is "turbulent," meaning that the flow is not specifically controlled or regulated. Nitric oxide is delivered through a supply line as part of the inspiratory flow. It is a mixed element.

[0014] As used herein, "false NO flow" and the like refers to the flow rate erroneously measured by a flow sensor. This pseudo-NO flow example includes, but is not limited to, the following examples: The NO flow rate measured by the flow sensor when no flow occurs is significantly different from the actual NO flow rate. There is a measurement of NO flow rate, which is a value.

[0015] The system and method of the present invention provides a method for delivering therapeutic gas from a delivery system to an injection module. Then, a breathing circuit (including but not limited to a high-frequency ventilator and / or any other suitable device) can be connected to the breathing circuit. and (ii) providing a fluid connection to the patient (including other applicable ventilators and / or ventilation techniques) and providing a respiratory The patient receives respiratory gas from the circuit. The system and method of the present invention includes at least one There is a treatment gas flow sensor, which measures the flow of treatment gas from the delivery system to the injection module. Advantageously, a therapeutic gas flow sensor is provided which measures the flow in the breathing circuit and to the patient. can measure flow in more than one direction (e.g., a bidirectional therapeutic gas flow sensor); and / or We address several surprising phenomena, which at times involve at least one of pressure and / or flow A breathing circuit with a variable volume ventilator (e.g., high-frequency ventilator) This occurs when therapeutic gas is mixed into the respiratory gas in a turbulent flow.

[0016] Additionally, the systems and methods of the present invention may incorporate techniques (e.g., algorithms, user input, (e.g., a ventilator that can vary at least the pressure and / or flow rate using (e.g., high-frequency ventilators) to compensate for at least some of the surprising phenomena. A surprising phenomenon that can be determined is that sometimes breathing with a ventilator This occurs when the therapeutic gas is mixed into the respiratory gas in the circuit with a turbulent flow. At times, information from at least a therapeutic gas flow sensor can be used, and the therapeutic gas The flow sensor is capable of measuring flow in one direction (e.g., a unidirectional flow sensor); and and / or may measure flow in more than one direction (eg, bi-directional flow sensor).

[0017] Additionally, the systems and methods of the present invention may be implemented using techniques (e.g., algorithms, user input, etc. and / or other features such as, but not limited to, the use of more efficient actuated valves. Factors that affect valve actuation, such as static friction, dynamic friction, and / or valve part interactions, to name a few. In at least some embodiments, the force that can be applied can be corrected. This results in increased accuracy of NO delivery and monitoring, and the therapeutic gas respiratory gas In-country supply shortages can be avoided and / or reduced.

[0018] Referring to FIG. 1, a breathing gas is received from a high-frequency ventilator via an injection module. 1 illustrates an exemplary nitric oxide delivery system 100 for delivering therapeutic nitric oxide gas to a patient receiving Any of the techniques of the present invention may be used in conjunction with respiratory equipment (e.g., ventilators, high-frequency ventilators, etc.). To deliver therapeutic gas to patients receiving respiratory gas from a For example, the system and method of the present invention can be used in: The supply system and / or other technology of the prior art patent document 1 (U.S. Pat. No. 5,558,083) The present invention relates to a method for providing a nitric oxide delivery system, and the method may use, modify, and / or add to the above-mentioned The contents of US Pat. No. 6,399,633 are incorporated by reference in their entirety.

[0019] Although the systems and methods of the present invention are sometimes indicated for use with high frequency ventilators, the present invention The system and method may be used with any applicable respiratory equipment. Any applicable respiratory equipment may be high frequency ventilators, any of which may encounter difficulties and / or problems. Any applicable breathing apparatus and / or reverse inspiratory pressure and / or pressure may be provided. Respiratory protection and / or ventilation techniques (e.g., bilevel positive pressure airway mask, pressure and / or any ventilation technique that varies flow rate, etc.) Therefore, calling it a high-frequency ventilator is not just a simplification. Additionally, sometimes intake pressure and / or flow may be reversed. Moreover, pressures and / or flows that may remain positive (e.g., high frequency sine waves) may be For simplicity, we will use the reverse intake pressure and / or flow rate. Creating refers to the pressure and / or flow rate that can sometimes remain positive (e.g., high This creates a situation where the intake pressure changes (frequency sinusoidal pressure and / or flow rate). Referencing pressure and / or flow is for simplicity and is not intended to be limiting.

[0020] The systems and methods of the present invention may be used with any applicable therapeutic gas. Therapeutic gases, therapeutic gas flow measurements, therapeutic gas delivery systems, and the like, are Nitric oxide gas (NO) is used to treat infections. It should be understood that other therapeutic gases may also be used. Thus, nitric oxide, NO, and and the like is for simplicity and is not intended to be limiting.

[0021] The systems and methods of the present invention include: It can be used to mix therapeutic gases into the gas in a turbulent flow. Therapeutic gases can mix turbulently with the patient's respiratory gases at points prior to the breathing circuit. According to another embodiment, in at least some instances, the patient's breathing circuit may include: It may include only one limb for both inspiration and expiration. For example, a BiPAP patient The respirator may have only one limb connecting the inspiratory and expiratory limbs. In accordance with this embodiment, the therapeutic gas can function as both the inspiratory and expiratory limbs. This can be mixed into the patient's respiratory gas in the limb that is being treated with turbulence. Patient breathing circuits are sometimes shown to have separate inspiratory and expiratory limbs. This is for the purpose of, and is not intended to be limiting.

[0022] In an exemplary embodiment, a nitric oxide delivery system, such as nitric oxide delivery system 100, The system is designed to introduce therapeutic gas (e.g. (e.g., nitric oxide, NO, etc.) as part of the patient's respiratory gas (e.g., ppm, etc.) , and / or as a pulse (e.g., ml / breath, mg / kg / hr, etc.), turbulent flow It can be used to mix NO or pulsed NO (e.g., (e.g., to mix with at least a turbulent flow) into the patient's respiratory gas. The nitric oxide delivery system 100 includes a nitric oxide source 103 (e.g., cylindrically stored NO, A device for receiving and / or having nitric oxide from, for example, a NO generator, via a conduit 105 Instead of a cylinder of NO-containing gas, NO can be generated at the bedside. and by a suitable chemical reaction, for example, a NO releasing agent such as nitrogen dioxide with a reducing agent such as ascorbic acid. The conduit 105 may further include a treatment gas inlet 110, for example. The injection module 107 may also be fluidly connected to the injection module 107 via the injection module 107. It can also be fluidly connected to the inspiratory limb of a breathing circuit with a high frequency ventilator 117 attached.

[0023] As shown, the high frequency ventilator 117 directs breathing gas (e.g., forward flow 133) An inhalation outlet that supplies the patient through the inhalation limb 121 of the patient's breathing circuit, and an exhalation outlet that receives the patient's exhalation and an expiratory inlet receiving expiratory air via the expiratory limb of the patient's breathing circuit. When the tube 107 is connected to the inhalation branch 121 of the breathing circuit, the nitric oxide is supplied to the nitric oxide supply From the supply system 100 (e.g., NO forward flow 137) to the injection module 107, a conduit 1 05 and / or therapeutic gas inlet 110. This nitric oxide can be delivered via the Thereafter, a high frequency power supply is used to deliver breathing gas to the patient 108 via the injection module. It can be delivered into the inspiratory limb 121 of the breathing circuit of a patient on a ventilator 117 .

[0024] The nitric oxide is then delivered through a conduit 105 to an injection module 107, which then delivers the breathing gas to the patient. To regulate the flow rate received from the circuit to the patient 108, the nitric oxide delivery system 100 , may have one or more control valves 109 (e.g., proportional valves, bidirectional valves, etc.). For example, when the control valve 109 is open, nitric oxide flows in the forward direction (e.g. NO forward flow 137) flows through conduit 105 to infusion module 107 and then to patient 108 In another embodiment, the control valve 10 When valve 9 is closed, nitric oxide cannot flow in the forward direction and is not delivered to the patient 108. It won't be done.

[0025] In at least some embodiments, the nitric oxide delivery system 100 comprises one or more The control valve 10 may include one or more NO flow sensors 115. The NO flow sensors 9 and / or the flow rate of therapeutic gas through conduit 105 (e.g., NO forward flow 137). The gas can then be passed through the treatment gas inlet 110 to the injection module 107 and then to the patient 10. It is possible to measure the flow rate of therapeutic gas up to 8. In an embodiment, the injection module 107 includes one or more breathing circuit gas (BCG) flows. A breathing circuit gas (BCG) flow sensor 119 may include: Patient breathing gas (e.g., forward flow) flows through the injection module 107 and then to the patient 108. As shown in the injection module 107, the flow rate of BCG The flow sensor 119 may be located anywhere in the expiratory limb 121, upstream of the infusion module 107. It can also receive flow information from a BCG flow sensor 119. Instead, the nitric oxide delivery system 100 receives a supply of breathing gas from a high frequency ventilator 117. Flow information may be received directly from the high frequency ventilator 117, which is indicative of flow.

[0026] In an exemplary embodiment, the systems and methods of the present invention include a therapeutic gas breathing system and Therapeutic gas breathing systems and methods may be used, modified, and / or adapted for use with the method. , and a bidirectional breathing circuit gas (BCG) flow sensor. One or more breathing circuit gas (BCG) flow sensors 119 are bidirectional; and / or Alternatively, the systems and methods of the present invention may further include one or more bidirectional breathing circuit gases ( For example, the systems and methods of the present invention may include a flow sensor. It can be used, modified, and / or adapted to work with other teaching materials and / or teaching systems. The above is based on the prior patent document 2 (U.S. Patent No. 14 / 672447, filed March 30, 2015). The document states, "System for delivering therapeutic gas to patients using accelerated breathing circuit gas (BCG) flow measurement" No. 6,399,433, entitled "System and Method for Producing Fluorescent Light Emitting Diodes in a Microchip," the contents of which are incorporated herein by reference in their entirety.

[0027] In an exemplary embodiment, the nitric oxide gas flow is proportional to the respiratory gas flow ( proportional to the supply voltage), in the mixed respiratory and therapeutic gas For example, the nitric oxide gas delivery system 100 may be configured to provide a predetermined concentration of NO. Using a known NO concentration from the NO source 103 in a mixture of respiratory and therapeutic gases with various amounts of NO by using a BCG flow sensor 119 to measure the patient's the amount of breathing gas in the conduit 105 using information from the NO flow sensor 115; is the amount of therapeutic gas flow to the injection module 107 at

[0028] At least for the purpose of delivering therapeutic gas to a patient and / or for the purpose of implementing some of the teachings disclosed herein. To at least perform the above-described steps, the nitric oxide delivery system 100 includes a control system. The control system may include one or more CPUs 111. The CPU 111 may be connected to a memory (not shown) and may also include one or more The readily available memory is e.g. Random Access Memory (RAM), Resource Read-only memory (ROM), flash memory, compact disc, floppy disk A diskette, hard disk, or local or remote digital storage device. Support circuits (not shown) are connected to the CPU 111 and include the CPU 111, sensors, Lubes, sampling systems, user input / displays, injection modules, breathing equipment, etc. These circuits may include cache memory, power supplies, and lines, clock circuits, input / output electrical circuits, subsystems, power control devices, signal con The CPU111 is a system that manages sensors, valves, sampling, and similar. Communication with the supply system, delivery system, user input / display, injection module, breathing equipment, etc. In an exemplary embodiment, the memory is When the program is executed, a set of machine executable instructions (or algorithms) can be stored and the program can be executed in a supply system. For example, the delivery system may be capable of performing the method. measuring the flow rate in the inspiratory limb of the patient's breathing circuit; delivering a therapeutic gas containing nitric oxide to the patient; and and monitoring the amount of therapeutic gas delivered at successive inspiratory flow rates ( The machine-implemented instructions also include a step of changing the volume or mass of the sample. It may also have instructions for any of the other methods described herein.

[0029] Additionally, to at least accurately administer the therapeutic gas, the nitric oxide delivery system 100 can have a user input / display 113, which can be The user interface may be a display and keyboard and / or buttons or a touch screen device. - Input / Display 113 receives predefined settings from the user and displays the patient's prescription (mg / kg Standard weight, mg / kg / hour, mg / kg / breath, mL / breath, cylinder concentration, fed concentration, sustained The user input / display 113 receives the patient's age, height, sex, weight, etc. It also accepts user input regarding operation modes, such as for use with high frequency ventilators. For example, the user input / display 113 may include a The device must be equipped with a button or other means to indicate that the device is to be used with a high frequency ventilator. User input / display 113 is used to define patient dosage and / or gas measurements. In at least some embodiments, for example, a sample line to a patient 108 A gas sampling system capable of receiving a sample of the gas supplied via 131. The gas sampling system 129 has many sensors. These include, but are not limited to, nitric oxide gas sensors, nitrogen dioxide gas sensors gas, and oxygen, which provide relevant information (e.g. gas concentration) to the user. The image can be used to display on the user input / display 113.

[0030] As shown in FIGS. 1 to 3, the CPU 111 controls the control valve 119, the user input / display 113, NO flow sensor 115, BCG flow sensor 119 and / or gas sampler The CPU 111 can communicate with the operating system 129 using an appropriate algorithm. Through the use of the present invention, any of the methods shown herein can be implemented.

[0031] The above-described method involves the use of a patient receiving respiratory gas from the breathing circuit of a high-frequency ventilated patient. Although the above method can be used to beneficially deliver therapeutic gas to at least some It is not possible to explain some surprising phenomena, such as the These occur when NO is mixed into the patient's respiratory gas as a fraction of the NO in a turbulent flow. Without knowledge of at least some of the phenomena, it is not possible to accurately measure NO concentrations (e.g., in the exhaled breath of a patient). The NO concentration in the inhaled gas (e.g., parts per million (PPM) NO) is different from the specified NO concentration ( (e.g., underdosing). This NO concentration can be used to administer the prescribed dose to the patient. Therefore, by explaining at least some of these phenomena, This allows for more precise NO dosing, avoiding and / or reducing underdosing of NO. can be done.

[0032] Turbulent mixing of NO with patient respiratory gas in a high-frequency ventilated breathing circuit. The surprising finding was that extensive research has revealed a decrease in NO flux (the false NO flux phenomenon). However, in at least some embodiments, the nitric oxide supply line (e.g., conduit 105 ) and / or the NO flow rate in the injection module (e.g., therapeutic gas inlet 110). The flow rate sensor 115 measures the flow rate (even if NO is not flowing). As a result, for example, the NO delivery system 100 can provide NO delivery and / or monitoring. This erroneous NO flow rate may cause the NO delivery system 100 to operate more slowly than expected. This will deliver less NO than is needed (e.g., underdosing), and the system will falsely believe that NO is being delivered. I recognize that.

[0033] These erroneous NO flow measurements are perceived as flow by the flow sensor, e.g. High frequency ventilator 117 may be equipped with a quick acting valve and / or a diaphragm (not shown). This is caused by vibrations or pressure vibrations caused by the NO2 gas. The NO2 delivery system 100 then It can be used for O supply and / or monitoring. The flow rate is measured by the flow sensor 115. This is because these vibrations or pressure vibrations are contained in the conduit 105. The NO gas being drawn is pressurized for a short period of time, and a very small flow rate of NO passes through conduit 105. As a result of the pressurization and / or depressurization (sometimes referred to as pressurization for simplicity), the NO flow sensor 11 The flow rates can be seen on the right side of the figure (e.g., NO forward flow rate 137). NO forward flow 137 occurs when there is no forward flow or flow at all (e.g., in the conduit 105, in the injection module 107 through the treatment gas inlet, etc.) and nitric oxide. Therefore, at least this false flow rate phenomenon may occur. This results in more accurate NO delivery and monitoring, and the delivery of therapeutic gas into the respiratory gas. Shortages can be avoided and / or reduced.

[0034] 2, in an exemplary embodiment, at least one embodiment that addresses the erroneous NO flow rate is At this time, a check valve 202 (e.g., a pneumatic check valve) is placed in fluid communication with the inspiratory limb 121. For example, a check valve can be placed in fluid communication with inspiratory limb 121. , not installed in the inspiratory limb 121. For other embodiments, the check valve 202 is In use, the check valve 202 may be installed in the inspiratory limb 121 upstream of the valve 107. open, arrive at the injection module 107 and / or measured by the flow sensor 115 Before the pump is turned on, any erroneous NO flow sources, oscillations, and / or pressure oscillations must be diverted. The use of a valve could address at least some of the issues associated with erroneous NO flow rates. However, these check valves also introduce many problems, including but not limited to: 23 For example, response delay flow from forward flow cracking pressure, surface seals and materials Contamination, part tolerances or material selection can affect sealing performance due to static physical attraction of materials. Due to repeated use between units, surface finishes can affect sealing performance, resulting in audible noise or It is characterized as an undamped spring-mass system that is vulnerable to the generation of forward flow-induced vibration "noise." and / or may impair flow control accuracy, repeatability, and control response time. .

[0035] In addition, the check valve 202 can prevent the ventilator from As shown, the device has a free-breathing valve 302. The free-breathing valve 302 (sometimes called a valve to prevent choking) The air passages (called ventilators) are open to the air, allowing the patient to breathe unconsciously using a ventilator. The free-breathing valve 302 allows air to be drawn from the patient who is unconsciously attempting to breathe. In order to have the ability to inhale, a respirator is required. When the ventilator does not have this free breath valve 302, the time for which breathing air is supplied to the patient is controlled. This free breathing valve is considered as a closed system with a ventilator. Otherwise, if the patient is unconscious and trying to breathe, the user may not be able to take in air and breathe. There is no airflow into the patient's breathing circuit. If the user attempts to breathe unconsciously, the free breathing valve will then The respirator can be operated to draw air from the free-breathing valve. Therefore, the check valve in the patient's breathing circuit allows obstruction from the free breathing valve, and the check valve will defeat the purpose of this safety feature and should not be used with this ventilator.

[0036] In an exemplary embodiment, at least reduce obstruction of the free-breathing valve 302 and / or To prevent this, the check valve 202 and / or the further check valve may be connected to the injection module 107, the treatment gas The inlet 110 and / or the conduit 105 may be located and / or in fluid communication with the inlet 110 .

[0037] In an exemplary embodiment, at least some of the above-mentioned phenomena (e.g., erroneous NO flow rate) are etc.) and / or to provide additional benefits, the NO flow rate may be increased upstream of the control valve. In this configuration (e.g., with the NO flow sensor upstream of the control valve), When the control valve is closed, the NO flow sensor is subject to at least some of the above-mentioned phenomena. For example, exposure to at least some of the above-mentioned phenomena can be significantly reduced and / or eliminated. To reduce and / or eliminate the NO flow sensor failure, the NO flow sensor 115 is In at least some examples, the NO flow sensor 109 may be located upstream of the NO flow sensor 109. The sensor 115, whether upstream or downstream of the valve 109, is used to ensure that the valve 109 is operating properly. Determine whether the valve 109 functions and / or does not leak through the valve For example, if the flow rate exceeds the expected value and the NO flow sensor 115 detects Thus, when detected, this can indicate a leak in the valve 109 .

[0038] In an exemplary embodiment, at least some of the above-mentioned phenomena (e.g., erroneous NO flow rate) are etc.) and / or to provide further benefits, a NO delivery conduit (e.g. Conduit 105) can have a very small cross-sectional diameter. For example, the NO supply conduit ( For example, the conduit 105) may have an inner cross-sectional diameter of about 1 / 32 inch to about 1 / 4 inch. In another embodiment, the NO delivery conduit (e.g., conduit 105) is about 1 / 8 inch The cross section can have an inner diameter of 0.01 mm to 0.01 mm. The cross section can increase the compressible volume in the NO delivery conduit. For example, a vibration signal detected by a flow sensor may be selected to be reduced. can be significantly reduced and / or effectively eliminated. The cross section can be selected to greatly increase the resistance to flow, and the pressure changes and / or high-frequency ventilator oscillation restores increased resistance to flow. and / or the transmission of pressure changes and / or vibrations is greatly reduced and / or can be reduced, for example, by using a NO flow sensor (e.g., a NO In at least some embodiments, the NO supply can be The inner cross-sectional diameter of the feed conduit (e.g., conduit 105) is the same inside and outside the system 100. The cross-sectional diameter and / or flow rate of the NO delivery conduit (e.g., conduit 105) may be It may be the same as the diameter of at least one downstream cross section of the control valve.

[0039] 4A-4B, an exemplary injection module is illustratively shown, which includes at least To address some of the above-mentioned phenomena (e.g., erroneous NO flow rates) and / or The injection module 400 has a first end 404 and a second end 405. 6, which can be coupled to the inspiratory limb of the patient's breathing circuit. At the first end 402 and the second end 406, there are a first opening and a second opening, respectively, and the injection module 400 In the main body of the device, a liquid (e.g., breathing gas) can be flowed through the injection module. The injection module 400 also includes a communication port 408, which is Communicates information between the module (and any additional components) and the nitric oxide delivery system. (e.g., hydraulic and / or pneumatic communication, electrical and / or digital communication) , etc.) The systems and methods of the present invention may use this information to, for example, The present invention addresses some of the above-mentioned phenomena and / or provides further benefits. The injection module 400 includes a treatment gas inlet 410. 410 can receive therapeutic gas from a nitric oxide delivery system and / or inject the therapeutic gas. Therapeutic gases can be injected into the breathing gas passing through the intake module.

[0040] In an exemplary embodiment, the injection module of the present invention includes one or more bidirectional N The O flow sensor 402 may include and / or be in fluid communication with, for example, at least Addressing some of the above mentioned phenomena (e.g., erroneous NO flow rates, etc.) and / or For example, the injection module 400 may include one or more bidirectional nitric oxide The device may include and / or be fluidly connected to a nitrogen oxide (NO) flow sensor 412. An O flow sensor 412 is located and / or fluidly connected to the treatment gas inlet 410. and / or the bidirectional NO flow sensor 412 can be connected to the NO supply conduit (e.g., 1) through a conduit 105) to the injection module 400 and / or to the patient's breathing circuit. In addition, a bidirectional NO flow sensor 41 can be used to measure the flow rate of the NO flowing into the inspiratory limb. 2 can be used as a feedback control oscillator for NO supply, and / or Or to monitor the flow rate and / or amount of NO gas delivered to the patient's breathing circuit. For example, the flow measured from the bidirectional NO flow sensor 412 can be This can be compared to the flow measurement from the flow sensor 115 that detects the O leak. As a result, more precise dosing and / or reduced risk of nitric oxide leakage into the surrounding environment may be achieved. This can reduce the risk.

[0041] In at least some embodiments, the treatment gas inlet 410 is shown However, a bidirectional NO flow sensor 412 is in fluid communication with the NO supply to the injection module. For example, a bidirectional NO flow sensor 412 may be located at any location where the nitric oxide supply is A supply system and / or NO supply conduit (e.g., conduit 105 shown in FIG. 1) and a fluid In another embodiment, the bidirectional NO flow rate can be Sensor 412 may replace NO flow sensor 115 (shown in FIG. 13) or may be can be used in combination.

[0042] In at least some embodiments, two or more bidirectional NO flow sensors may be located and / or fluidly connected to the treatment gas inlet 410. For example, One or more bidirectional NO flow sensors may be installed at the treatment gas inlet 410. and / or one or more bidirectional NO flow sensors may be connected to the treatment gas inlet 410. The two or more bidirectional NO flow sensors can be, e.g. For example, the NO2 delivered through the injection module 400 for a very wide range of flow rates can be The flow rate can be measured.

[0043] In an exemplary embodiment, the bidirectional NO flow sensor 412 is configured to measure NO in both forward and reverse directions. The sensor can be any sensor that can measure the flow rate in both directions. For example, The flow sensors 119 may be thermal mass flow meters (sometimes called thermal dispersion flow meters); pressure-based flowmeters; optical flowmeters; electromagnetic, ultrasonic, and / or Coriolis flowmeters; laser Doppler - Flowmeters and / or flowmeters that provide a response time of less than approximately 2 milliseconds and no greater than +-10 SLPM The flowmeter may be any flow meter having a wide range. Exemplary limits for reverse flow are: 10, -9, -8, -7, -6, -5, -4, -3, -2.5, -2, -1.5, -1, -0.75, It can be -0.5, -0.4, -0.3, -0.2 or -0.1 SPLM. ,Exemplary limits for forward flow are 10, 9, 8, 7, 6, 5, 4, 3, 2.5, 2, 1. It can be 5, 1, 0.75, 0.5, 0.4, 0.3, 0.2 or 0.1 SPLM. In at least some embodiments, the bidirectional flow sensor 119 is a pressure-based and / or , fluid and / or pneumatic communication can be provided via communication port 408.

[0044] In an exemplary embodiment, bi-directional NO flow sensor 412 is connected to communication port 4, for example. 08, the device can be fluidly connected to a nitric oxide delivery system. The amount of information can be communicated to a nitric oxide delivery system to facilitate NO delivery and / or monitoring. This bidirectional flow information can be used by the nitric oxide delivery system for When using this information, the nitric oxide delivery system can more accurately deliver and / or monitor NO. You can do this.

[0045] In an exemplary embodiment, the systems and methods of the present invention use techniques (e.g., algorithms, User input, etc.) can be used to determine whether high frequency ventilation is available. Further, in an exemplary embodiment, the device is defined as using a high-frequency ventilator. At this time, the systems and methods of the present invention use techniques (e.g., algorithms, user input, etc.) to This allows us to avoid at least some surprising phenomena (e.g., erroneous NO fluxes). Correct and / or sometimes in the breathing gas in the breathing circuit of a high-frequency ventilator Affect the surprising phenomenon that occurs when therapeutic gases are mixed in turbulent flows; and / or These techniques sometimes provide additional benefits, at least from the therapeutic gas flow sensor. The information can be used by the therapeutic gas flow sensor, the NO flow sensor 115 (e.g. , capable of measuring flow in one direction), NO flow sensor 412 (e.g., capable of measuring flow in more than one direction), and / or the injection module, the treatment gas inlet, and / or The NO conduit may be any flow sensor in fluid communication with the NO conduit.

[0046] The systems and methods of the present invention involve the delivery of therapeutic gas (e.g., NO) to a ventilated breathing circuit. Any reasonable technique may be used to determine whether the equipment is provided within the Techniques include, but are not limited to, user input (e.g., nitric oxide supply), to name a few. user-entered information into the delivery system), detection (e.g., detection by the nitric oxide delivery system) algorithms), signal recovery, and / or any combination thereof and / or further For example, there are systems that use nitric oxide for delivery, such as a ventilator. Therefore, the user can input that NO is to be supplied to the breathing circuit of the high-frequency ventilator. In another embodiment, the nitric oxide delivery system provides high frequency artificial respiration of NO. In a breathing circuit with a ventilator, for example, detection and / or signal recovery techniques can be used to detect This can be done.

[0047] In an exemplary embodiment, once it has been determined that a high frequency ventilator is in use, The system and method are capable of preventing at least some surprising phenomena (e.g., erroneous NO flow phenomena). etc.), and / or any other appropriate Further benefits may be provided using suitable techniques, including but not limited to, but not limited to, Examples include filtration, the use of reduction techniques, any combination thereof, and / or further fractionation. Either one that can correct the information generated by the high-frequency ventilator with NO flow information Use of the process, changes to the NO supply control algorithm to prevent high-frequency vibration, Air filtration, digital filtration, NO flow sensor located upstream of the flow control valve, very Small diameter NO injectors and / or pneumatic filtration. The system and method can consider high frequency ventilator generated information as noise, Using any suitable technique, this noise can be filtered out to NO flow information (e.g., from a NO flow sensor). Information) can be removed from the computer. Techniques include, but are not limited to, Linear filters, non-linear filters, statistical signal processing, noise gates and / or Any combination and / or further subdivision of these may be used.

[0048] For ease of understanding, at least some exemplary detection and / or signal recovery techniques and Exemplary compensation techniques are disclosed herein, it being understood that other techniques may also be used. Furthermore, the technology disclosed in the present invention is for easy understanding and is not intended to be limiting. I want you to understand this.

[0049] By way of example, it is possible to determine whether NO is delivered into the breathing circuit of a ventilator. To this end, the systems and methods of the present invention may be used in conjunction with a pressure and / or high frequency ventilator system. In at least some embodiments, pressure and flow information indicative of and / or flow information from the NO flow sensor. 5 (illustrated in FIG. 13), and / or a bidirectional NO flow sensor (illustrated in FIG. 4A-4B). (illustrated below) and can be analyzed (e.g., by a nitric oxide delivery system) , whether a high-frequency ventilator is in use. For example, the NO flow rate The information from the sensor is analyzed against expected information from a NO flow sensor, and / or The actual NO flow information is generated by the high-frequency ventilator, which is far from the actual NO flow information. Depending on the embodiment, information from a NO flow sensor may be identified, to name a few. , forward and / or reverse flow and / or pressure not expected for high frequency, expected for high frequency No forward flow and / or pressure, no high frequency expected zero and / or forward and / or Reverse flow rates are shown and can be analyzed against expected flow information.

[0050] 5A and 5B, exemplary graphical representations of information from a NO flow sensor are shown. and at least one exemplary method for determining whether a high-frequency ventilator is being used. The information from the NO flow sensor may be in the form of current, voltage, and / or flow. It should be understood that the information may be in any other form indicative of volume and / or pressure. The illustrated flow rates are shown by way of example, for simplicity and not by way of limitation.

[0051] Referring to FIG. 5A, a plot 502 shows the NO flow for a given flow rate of 10 ml / min. The following shows an example of expected information from the volume sensor, e.g., when the patient is not on a high-frequency ventilator: As shown, the plot 502 is nearly linear. Considered as a line, plot 502 represents the flow rate at a constant flow rate (e.g., a constant 10 ml / min). The expected information from the NO flow sensor versus flow rate is shown. Of course, When it is not constant, the plot will respond accordingly. For example, if you apply a constant flow rate to It is easy to provide a single unit of air to one portion of the circuit and then change it to another portion of the patient's breathing circuit. For the sole purpose of understanding, a constant flow rate is illustrated. This is for simplicity and is not limiting. There is none.

[0052] Referring to FIG. 5B, a plot 504 illustrates an example flow rate of 0 ml / min versus NO flow rate. 1 illustrates an exemplary high frequency ventilator's expected information from a volume sensor. The plot 504 can be thought of as a non-linear shape (e.g., a sine curve, etc.) and the plot The plot 504 shows information from the NO flow sensor for vibration or pressure vibration. The pressure oscillations may be generated, at least in part, by, for example, a high frequency ventilator.

[0053] Referring to FIG. 5C, plot 506 shows the flow rate when bent by vibration or pressure oscillations. Illustrative actual information from a NO flow sensor for a volume measurement of 10 ml / min is shown. Plot 506 is an exemplary plot from a NO flow sensor for a given flow rate of 10 ml / min. Expected information (e.g., plot 502 in FIG. 5A) and Example information from a NO flow sensor showing generated or pressure oscillations. These deformations can be thought of as bending the nitric oxide delivery system. The flow rate is now considered to be different from the prescribed constant flow rate of 10 ml / min. (Even though these variations indicate false NO flow rates and not actual NO flow rates).

[0054] The problem is that the NO delivery system responds to this erroneous flow rate information by adjusting the amount of gas delivered to the breathing circuit. The flow rate is adjusted to try to provide a new flow rate. This adjusted flow measure is based on the flow rate in the breathing circuit and is not an actual flow measure. This allows the actual delivery of NO to be effected at a rate other than the given flow rate measure.

[0055] In addition to the problems mentioned above, the NO delivery system must regulate the flow of gas into the breathing circuit. To test the flow rate at a given rate, the supply valve (e.g., valve 109) Activate (e.g. open, close, partially open, partially close, etc.) The actuation of this valve may, in at least some embodiments, result in at least a delay in delivery. The interaction of the valve components can be time-dependent. When trying to regulate the volume (which is not necessary), close the valve to reduce static friction and / or The valve reopens to restore the force applied by the kinetic friction. These forces are not constant ( For example, more force is required to recover from kinetic friction than from static friction), This can cause a delay in the movement and / or delivery of NO. Therefore, using the techniques disclosed herein, the time at which the system attempts to adjust the NO flow rate can be reduced. The length is reduced and / or eliminated, which results in a reduction in the occurrence of the above problems. In at least some embodiments, this results in increased accuracy of NO delivery and monitoring. and / or to avoid and / or reduce undersupply of therapeutic gas into the respiratory gas. can.

[0056] In an exemplary embodiment, the system and method of the present invention address at least the above-mentioned problems. The method and technique (e.g., algorithms, user input, etc.) are used to more effectively and accurately measure can be used to compensate for and limit forces affecting valve actuation. However, static friction, dynamic friction, and / or valve component interactions, to name a few, may occur. For example, the systems and methods of the present invention may sometimes require a large amount of force to recover. Identify, factor, and / or correct for quantities of friction (e.g., static friction, kinetic friction, etc.).

[0057] With further reference to FIG. 5A and FIG. 5C, the use of a high-frequency ventilator according to the above-described embodiment is examined. To provide this, the system and method of the present invention converts actual information from the NO flow sensor into a predetermined The expected information from the NO flow sensor related to flow rate can be analyzed. For example, when delivering NO at 10 ml / min, the nitric oxide delivery system is The actual information from the NO flow sensor (e.g., as shown in plot 506 of FIG. 5C) is 5A) against the expected information from the user (e.g., as shown in plot 502 of FIG. 5A). Then, identify the actual deviation, and then the nitric oxide supply system will supply NO to the high-frequency ventilator It is possible to define that the air is being supplied to the breathing circuit with the It is possible to achieve a flow rate of less than 80 oscillations per minute, so the respiration rate of the 10-mile ventilator is The average breathing rate is less than 80 breaths per minute, but the vibrations from a high-frequency ventilator can reach several hundred magnitudes per minute. It is Jude.

[0058] In accordance with the above-described embodiment, when the use of a high-frequency ventilator is detected, the system and The method can correct at least the information generated by the high frequency ventilator. For example, the nitric oxide delivery system uses information from the NO flow rate to generate This high frequency ventilator is prone to generate information that indicates vibration or pressure oscillations. Once the information is filtered, the nitric oxide delivery system delivers the correct NO dose to the patient. It can be provided.

[0059] In addition to the above changes, at least the above-mentioned erroneous NO flow phenomenon sometimes occurs at very low flow rates. Furthermore, at least the above phenomenon is observed at flow rates below 100 ml / min. The information may be distorted to a large enough extent that zero and / or negative flows are believed to occur. Problematically, very low flow rates may be advantageous and / or may be required for a given dosage. The amount of NO required to deliver to the patient is sufficient to detect and / or correct at least the above phenomena. Failure to do so can sometimes result in a dose that is not the intended therapeutic dose and can sometimes affect efficacy. It will be supplied to patients.

[0060] In an exemplary embodiment, the smaller variations include unidirectional and / or bidirectional flow sensors. Use information from the bidirectional flow sensor to correct and / or correct large deformations. This requires the use of additional information and / or requires further techniques. 5, plot 506 is between 5 ml / min and 15 ml / min, with a given flow rate of 10 ml / min. In this embodiment, the detection and / or correction of erroneous NO flow rates is performed in a unidirectional manner. This is achieved by a one-way flow sensor and / or a two-way flow sensor, e.g., the flow rate is 0 m However, in an exemplary embodiment, the predetermined flow rate is not less than 0 ml / min. The detection and / or correction of the deformations becomes more complicated and / or requires the use of bidirectional flow sensors. may be required.

[0061] For example, referring to FIG. 6A, plot 606 shows a 10 ml / min variation. / min indicates a given flow rate (e.g. plot 6060 is between 25ml / min and 5ml / min) The flow rate varies between points 608 and 610 and is less than 0 ml / min. The negative area between points 608 and 610 on lot 606 represents an erroneous NO flow rate in the reverse direction. If we consider that this flow rate is in the opposite direction, then it can be considered as a bidirectional flow sensor. Using this information, plot 606 appears as shown in FIG. 6A, but with a unidirectional flow rate. Using the sensor information, a plot 606 appears as shown in FIG. no volume, 0 ml / min flow rate, etc.) and / or as shown in FIG. 6C (e.g., Equal or opposite positive flow rates, positive valve against negative valve)

[0062] In an exemplary embodiment, a bidirectional flow sensor and / or The information detects and / or detects deformations that indicate very low flow rates and / or flow rates below 0 ml / min. The information from the bidirectional flow sensor is used to correct the and / or to correct the information from the NO flow sensor. The use of such information may include, but is not limited to, any of the techniques disclosed herein. Demonstrate that high frequency ventilators generate vibrations or pressure oscillations using any suitable technique. .

[0063] Referring to FIG. 6B-6C, in an exemplary embodiment, a unidirectional flow sensor and / or Information from the unidirectional flow sensor indicates very low flow rates and / or flow rates below 0 ml / min. can be used to detect and / or correct the deformations exhibited by the These techniques include, but are not limited to, interpolation, curve fitting, and / or regression, to name a few. There is analysis.

[0064] For example, a unidirectional flow sensor and / or information from a unidirectional flow sensor may be used to To detect the use of a high-frequency ventilator, the system and method of the present invention Then, the actual information from the NO flow sensor is compared to the expected information from the NO flow sensor. This technology is expected to provide more information than expected from the NO flow sensor. When used, the systems and methods of the present invention may be used in conjunction with, but are not limited to, any of the devices disclosed herein. The desired information from the NO flow sensor can be obtained using any suitable technique, such as A positive value above this is considered to detect the use of high frequency ventilation.

[0065] According to the above-mentioned embodiment, the unidirectional flow sensor and / or information from the unidirectional flow sensor When the use of a high frequency ventilator is detected using the present system and method, However, it is not necessary to use any suitable technique, such as any of the techniques disclosed herein, to Information indicative of high frequency ventilator generated vibrations or pressure oscillations can be corrected. For example, for the region between points 608 and 610 of plot 606 (shown in FIG. 6B ), The system and method of the present invention can add and limit missing plot information. However, the invention is not limited to the above, and may be modified using any suitable technique, such as any of the techniques disclosed herein. For another embodiment, the distance between points 608 and 610 of plot 606 can be corrected. For regions (as shown in FIG. 6C), the systems and methods of the present invention invert these values (e.g., considering positive values ​​as negative values) and, without limitation, Transform it (e.g., to make it appear as if it were a real object) using any reasonable technique, such as any technique for displaying the deformation and / or reversed deformation) can be corrected.

[0066] Those skilled in the art will recognize that many adaptations and modifications are readily available. A therapeutic gas delivery system can be configured to deliver the formulation gas of the present invention, so that The present invention provides an improved method and system for delivering a predetermined amount of medicinal gas into a patient, all of which comprises the steps of: The present invention is within the scope of the present invention as defined in the following claims. and the equivalent thereof.

[0067] Throughout this specification, the terms "one embodiment," "an embodiment," "one or more embodiments," " "exemplary embodiment", "exemplary embodiments" and / or "embodiments" are , the particular characteristics described in relation to the embodiment having at least one embodiment of the present invention; Thus, in various places throughout this specification, "a" refers to a structure, material, or feature. In one or more embodiments, "in a particular embodiment," and / or "in one embodiment," Phrases such as "in the form of" do not necessarily refer to the same embodiment of the invention. The properties, structures, materials, or characteristics may be described in any suitable manner in one or more embodiments. can be combined.

[0068] Any of the steps described may be rearranged, separated, and modified without departing from the scope of the present invention. It should be understood that steps may be combined and / or may be combined. For simplicity, steps are sometimes They are consecutive. This is merely for simplicity and is not limiting.

[0069] Moreover, any elements and / or embodiments of the invention described may be modified without departing from the scope of the invention. It should be understood that the above-mentioned components may be rearranged, separated, and / or combined without departing from the spirit and scope of the present invention. For simplicity, elements are sometimes described separately. This is merely for simplicity and is not intended to be limiting. Not at all.

[0070] Although the present invention has been described with reference to specific embodiments, these embodiments are not intended to limit the scope of the present invention. It should be understood that this is merely illustrative of the principles and applications of the present invention. Various modifications and alterations will occur to those skilled in the art. It is apparent that changes may be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, the present invention is provided for modifications and variations within the scope of the appended claims and their equivalents. Indicates that the setting includes changes.

Claims

1. 1. A method of operating a system for delivering therapeutic gas into respiratory gas in an inspiratory limb of a breathing circuit of a high frequency ventilated patient, the system comprising: an injection module configured to inject a therapeutic gas into respiratory gas in the inspiratory limb of a patient's breathing circuit; at least one control valve of the nitric oxide delivery system; at least one bidirectional NO flow sensor; a control system in communication with the at least one bidirectional NO flow sensor; Equipped with A method of operating the system includes: providing a flow of therapeutic gas with the at least one control valve; measuring forward and reverse NO flow rates through a therapeutic gas inlet of the injection module with the at least one bidirectional NO flow sensor, the at least one bidirectional NO flow sensor being fluidly connected to the therapeutic gas inlet of the injection module; receiving, with the control system, bi-directional flow information from the at least one bi-directional NO flow sensor, the bi-directional flow information including at least forward flow information and reverse flow information, the control system using the bi-directional flow information to detect flow rates below 0 ml / min, indicative of spurious NO flow rates, and / or to compensate for flow rates below 0 ml / min, indicative of spurious NO flow rates; A method of operating the system.

2. 2. A method of operating the system of claim 1, wherein the control system is operable to use the bidirectional flow rate information to ensure that a desired dosage of NO is delivered into the injection module and then into a patient's breathing gas in the inspiratory limb of the breathing circuit.

3. 2. A method of operating the system of claim 1, wherein the control system is operable to use the bidirectional flow rate information to avoid under-delivery and / or under-administration of a desired dose of NO.

4. 10. A method of operating the system of claim 1, wherein the therapeutic gas comprises one or more of: (i) nitric oxide; and (ii) a nitric oxide releasing agent.

5. 2. The method of claim 1, wherein the control valve is upstream of the NO flow sensor in the nitric oxide delivery system.

6. 10. A method of operating the system of claim 1, wherein the therapeutic gas inlet receives a flow of therapeutic gas through a conduit, the conduit satisfying one or more of: (i) having an inner cross-sectional diameter of about 1 / 32 inch to about 1 / 4 inch; and (ii) having an inner portion within a nitric oxide delivery system and an outer portion outside the nitric oxide delivery system, the inner portion of the conduit having a cross-sectional diameter approximately the same as a cross-sectional diameter of the outer portion of the conduit.

7. A method of operating the system of claim 1, comprising the steps of: measuring NO flow rate with at least one second NO flow sensor, the second NO flow sensor in fluid communication with the therapeutic gas inlet and in communication with the control system; A method of operating a system, wherein the control system receives flow information from the NO flow sensors and detects a leak when the flow information from the NO flow sensors does not match.

8. 8. A method of operating a system as recited in claim 7, further comprising increasing the flow rate of the therapeutic gas when a leak is detected.

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