Systems for inhalation of therapeutic and diagnostic gas and methods of use thereof

Abstract

In one embodiment, the present invention provides a system for delivering at least one therapeutic gas to a spontaneous breathing patient, wherein the delivery rate of at least one therapeutic gas exceeds the patient's inspiratory flow rate, and the amount of at least one therapeutic gas wasted is minimized or eliminated.

Description

Technology Field

[0001] Related applications

[0002] This application was filed on January 27, 2016, and claims priority to U.S. Patent Application No. 62 / 287,652, titled “Nitric Oxide Intake System,” the entirety of which is incorporated herein by reference for all purposes.

[0003] Technology field

[0004] The present invention relates to a system for delivering at least one therapeutic gas to a spontaneously breathing patient, wherein the delivery rate of at least one therapeutic gas exceeds the patient's inspiratory flow rate, and the amount of at least one therapeutic gas wasted is minimized or eliminated. Background Technology

[0005] Inconsistent and inaccurate concentrations of therapeutic gas administered to a patient can reduce the effectiveness of the therapeutic gas administered to the patient. Prior art literature

[0006] U.S. Patent Publication US2011 / 0277754 (2011.11.17)

[0007] In one embodiment, the present invention provides a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0008] a. At least one reservoir tube having a proximal end and a distal end, having a volume greater than the tidal volume of the patient's respiration,

[0009] b. At least one therapeutic gas inlet located at the proximal end of at least one storage tank tube, wherein the delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and

[0010] c. Includes a patient interface fluidly connected via a check valve to the proximal end of at least one reservoir tube, and

[0011] The patient interface is configured to form a hermetic seal between the patient and the system, and the inspiratory check valve is configured to close when the patient exhales, and

[0012] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a time-averaged flow rate greater than the patient's time-averaged inspiratory flow rate, and at least one therapeutic gas flows along at least one reservoir tube from the proximal end to the distal end while the patient exhales, and

[0013] The volume of at least one therapeutic gas introduced into at least one reservoir tube during the patient's exhalation is greater than the patient's inspiratory tidal volume, and

[0014] The inspiratory check valve is configured to open when the patient inhales, and

[0015] The inhalation check valve is configured to allow at least one therapeutic gas to be administered to the patient.

[0016] In one embodiment, the system further includes a second check valve, the second check valve is configured to be closed while the patient inhales and open while the patient exhales, and the system is configured so that the second check valve exhausts the gas exhaled by the patient.

[0017] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is configured to minimize the effort required by the patient to perform inhalation, exhalation, or both inhalation and exhalation.

[0018] In one embodiment, at least one reservoir tube is also configured to minimize the effort required by the patient to perform inhalation, exhalation, or both inhalation and exhalation.

[0019] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is also configured to monitor the flow of gas through the proximal end of at least one reservoir tube.

[0020] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is also configured to monitor at least one parameter of the flow of gas through the proximal end of at least one reservoir tube, and

[0021] At least one parameter includes concentration, flow, contamination, or any combination thereof.

[0022] In one embodiment, at least one storage tank tube further includes a flow meter at the distal end.

[0023] In one embodiment, at least one storage tank tube further includes a flow meter that responds to the flow rate and flow direction within the storage tank, and the flow meter may be positioned at the distal end of the storage tank for convenience.

[0024] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is also configured to monitor at least one parameter of at least one therapeutic gas introduced into the system configured to administer at least one therapeutic gas to a patient, and the at least one parameter includes concentration, flow rate, flow volume, contamination level, or any combination thereof.

[0025] In one embodiment, at least one reservoir tube further includes a sampling port at the proximal end.

[0026] In one embodiment, the sampling port is configured to deliver gas to a patient, to monitor the gas delivered to the patient, to specify the gas delivered to the patient, or to perform any combination thereof. In one embodiment, the gas is specified by its contents, contamination level, flow rate, flow volume, concentration, or any combination thereof.

[0027] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is also configured to emit an alarm when a monitored value of either the concentration or the corresponding flow rate of at least one therapeutic gas deviates from a threshold value. As used herein, the threshold value may include any one of an upper limit, a lower limit, or a combination of upper and lower limits, and a monitored value is evaluated to determine whether an alarm state exists above, below, or outside of it. As a non-limiting example, upper and lower threshold values ​​for an acceptable therapeutic level of oxygen concentration may be used in the system to alert an operator when a superoxygenated or hypooxygenated breathing mixture is delivered.

[0028] In one embodiment, a system configured to administer at least one therapeutic gas to a patient is also configured to change the flow rate and / or the concentration of at least one therapeutic gas when a monitored value of any one of the characteristics of at least one therapeutic gas, or the flow rate deviates from at least one threshold value.

[0029] In one embodiment, at least one therapeutic gas comprises nitric oxide, helium, carbon dioxide, hyperoxic gas, hypoxic gas, tracer gas, or any combination thereof. In one embodiment, the concentration of nitric oxide is 160 ppm in a mixture of oxygen and nitrogen. In one embodiment, at least one therapeutic gas is nitric oxide. In one embodiment, nitric oxide is present at a concentration of 0.5 ppm to 400 ppm.

[0030] In some embodiments, at least one therapeutic gas is a diagnostic gas.

[0031] In some embodiments, at least one therapeutic gas is oxygen. Brief explanation of the drawing

[0032] FIG. 1 illustrates a graph showing the normal volume of air in the lungs during a normal inspiratory cycle of a patient requiring the treatment method described in this specification. FIGS. 2a to 2d illustrate the operation of a gas delivery system according to some embodiments of the present invention at key points through a patient's breathing cycle. FIG. 3 illustrates a gas delivery system according to some embodiment of the present invention in which a patient breathes from the proximal end of a reservoir through a mouthpiece. FIG. 4 illustrates a gas delivery system according to some embodiment of the present invention in which a patient breathes through a nasal mask. FIGS. 5A and 5B illustrate a gas delivery system according to some embodiments of the present invention, configured to have both an inspiratory check valve and an expiratory check valve. An alternative patient connection is illustrated in FIGS. 5A and 5B. FIG. 6 illustrates a gas delivery system according to some embodiment of the present invention, wherein the gas delivery system is configured to have an inhalation check valve and an exhalation check valve, and an exhalation exhaust tube for discharging exhaust gas from a patient. FIG. 7 illustrates a gas delivery system according to some embodiment of the present invention, wherein the therapeutic gas contains two components that are delivered separately toward the proximal end of the storage tank and injected separately into the storage tank. FIG. 8 illustrates a gas delivery system according to some embodiment of the present invention, wherein the storage tank is formed of two or more tubes and two or more types of gases are transported separately to the storage tank. FIG. 9 illustrates a gas delivery system according to some embodiment of the present invention, wherein the reservoir is manufactured from a plurality of small tubes that provide the total volume required. This figure also introduces both a sample port and a sample line, wherein a small amount of gas present at the proximal end of the reservoir can be recovered through the sample line for analysis and monitoring. This sample port is positioned at the far side of the inhalation valve to be effectively isolated from the patient's exhalation. FIG. 10 illustrates a gas delivery system according to some embodiment of the present invention, in which a long storage tube is coiled to reduce its physical size. FIGS. 11 through 14 illustrate a gas delivery system according to some embodiments of the present invention, wherein a plurality of source gases forming a final therapeutic mixture are mixed before being injected into the proximal end of a reservoir. FIG. 11 highlights an arrangement using a nasal mask and one inhalation check valve, in which the patient is trained to inhale through the nose and exhale through the mouthpiece. FIG. 12 illustrates an embodiment in which a face mask is used with a dual check valve "tee," in which the tee integrates an inhalation check valve and an exhalation check valve to direct the inhaled gas and the exhaled gas. FIGS. 13 and 14 are similar to FIG. 12 but are optionally configured to have a nose mask and a mouthpiece, allowing the patient to selectively exhale through the mouth (according to FIG. 13) and through the nose (according to FIG. 14) to reduce exhalation effort. FIG. 15 illustrates a gas delivery system according to some embodiment of the present invention, wherein the face mask is modified so that an intake check valve and an exhalation check valve are supplied from a reservoir equipped with an injection port, and a stable flow source of oxygen-rich air and a stable flow source of NO are combined and supplied to the injection port. FIG. 16 illustrates a gas delivery system according to some embodiment of the present invention, wherein one or more therapeutic gases are mixed with one or more diluent gases and the mixed gases are combined in a mixing area before being injected into a storage tank. FIG. 17 illustrates a gas delivery system according to some embodiment of the present invention, wherein a plurality of incoming gas flows are mixed to form a total therapeutic gas mixture injected into a storage tank, and individual gas flows are generated by a flow metering system comprising a single unit. FIG. 18 illustrates a gas delivery system according to some embodiment of the present invention, wherein two incoming stable gas flows are mixed to form a total therapeutic gas mixture injected into a storage tank, the first stable gas flow is generated by a concentrated oxygen-air mixer and the second stable flow is generated by a NO flow metering device. FIG. 19 illustrates a gas delivery system according to some embodiment of the present invention, in which a plurality of incoming stable gas flows are separately injected into the proximal end of a storage tank. FIG. 20 illustrates a gas delivery system according to some embodiment of the present invention, wherein the configuration shown in FIG. 5a is modified by adding a sample port between the inhalation check valve and the exhalation check valve to provide means for sampling patient inhalation gas and patient exhalation gas. FIG. 21 illustrates a gas delivery system according to some embodiment of the present invention, wherein at least one storage tank tube is also configured to include a flow meter at a distal end, and said flow meter responds to both the flow rate and the direction of flow within at least one storage tank. FIG. 22 illustrates a gas delivery system according to some embodiment of the present invention, wherein a reservoir is configured to operate as part of a therapeutic gas delivery system configured to determine an average infusion flow requirement, the average infusion flow requirement is monitored from the gas flow within the reservoir over a time frame of at least one patient breathing cycle, and the average infusion flow requirement is used to periodically adjust the average infusion flow of at least one therapeutic gas. Specific details for implementing the invention

[0033] For clarity of disclosure that is not limiting, the detailed description of the invention is divided into the following subsections that describe or illustrate specific features, embodiments, or uses of the invention.

[0034] In some embodiments, the present invention provides a system for delivering at least one therapeutic gas to a spontaneously breathing patient, wherein the average delivery rate of at least one therapeutic gas meets or exceeds the patient's average inspiratory flow rate. In some embodiments, the amount of at least one therapeutic gas wasted is minimized or eliminated.

[0035] In some embodiments, the present invention provides a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0036] a. At least one reservoir tube having a proximal end and a distal end and a volume greater than the patient's tidal volume,

[0037] b. At least one therapeutic gas inlet located at the proximal end of at least one storage tank tube, wherein the delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and

[0038] c. Includes a patient interface fluidly connected via a check valve to the proximal end of at least one reservoir tube, and

[0039] The patient interface is configured to form a hermetic seal between the patient and the system, and

[0040] The inspiratory side of the check valve is configured to close when the patient exhales, and

[0041] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a time-averaged flow rate greater than the patient's time-averaged inspiratory flow rate (patient minute volume), and at least one therapeutic gas flows along at least one reservoir tube from the proximal end to the distal end while the patient exhales.

[0042] The volume of at least one therapeutic gas introduced into at least one reservoir tube during the patient's exhalation is greater than the patient's inspiratory tidal volume, and

[0043] The inspiratory check valve is configured to open when the patient inhales, and

[0044] The inhalation check valve is configured to allow at least one therapeutic gas to be administered to the patient.

[0045] In some embodiments, at least one reservoir is configured to allow the therapeutic gas to flow in reverse as a stable infusion flow that alternately is higher and then lower than the instantaneous patient inspiratory flow between the proximal and distal ends. In some embodiments, at least one reservoir is configured to move the therapeutic gas without substantially mixing in the longitudinal flow direction.

[0046] In some embodiments, the storage channel may typically have a cross-section having a geometric shape, and the geometric shape may be circular, elliptical, octagonal, square, rectangular, hexagonal, etc., although not limited thereto.

[0047] The following symbols defined herein are illustrated in the drawings:

[0048] = Total injection flow rate

[0049] = Injection flow rate of a specific component gas stream, One of the "n" possible components is each designated by the subscript "x" so as to become

[0050] FIG. 1 illustrates a graph representing the typical volume of air in the lungs during a patient's normal inspiratory cycle. Tidal volume may vary due to factors such as the patient's age, health status, and size. As used herein, "tidal volume" refers to the lung volume representing the normal volume of air displaced between normal inspiration and expiration when no extra effort is applied. Thus, tidal volume is the maximum volume taken at the end of a normal diastolic inspiration. As a non-limiting example, in a healthy young adult, tidal volume is about 500 mL per inspiration or 7 mL per kg of body weight. Accordingly, "minute volume" ( "" refers to the total inspiratory volume per minute, corresponding to tidal volume per breath × respiratory rate per minute. For example, a patient breathing a tidal volume of 500 mL and breathing 20 times per minute has 10 lpm (= 20 × 500 mL per minute) of has

[0051] FIG. 2 illustrates the operation of a device according to some embodiment of the present invention during a patient's normal breathing cycle. In FIG. 2a, the patient is exhaling, and a check valve labeled "inspiratory check valve" is closed to prevent gas exhaled by the patient from entering at least one reservoir tube. Instead, gas exhaled by the patient is discharged from the system through a check valve labeled "exhalatory check valve." At least one therapeutic gas is introduced into the system through an inlet located on the reservoir side of the inspiratory check valve at the proximal end of at least one reservoir tube and flows toward the distal end of at least one reservoir tube, which is open to neutral pressure, in this case, ambient room air.

[0052] In FIG. 2b, the patient is inhaling and the check valve labeled "inhalation check valve" is open, so that at least one therapeutic gas in at least one reservoir tube and simultaneously the rate At least one therapeutic gas introduced into the system through the intake port is introduced into the patient's airway. A check valve labeled "expiratory check valve" is closed to prevent the patient from inhaling ambient air. When the patient inhales, ambient air at neutral pressure is drawn in and introduced into the distal end of at least one reservoir tube. However, at least one reservoir tube is configured to prevent the incoming ambient air from improperly mixing and diluting with at least one therapeutic gas present in the reservoir tube.

[0053] In FIG. 2c, the patient is near the end of the inspiratory cycle, and the check valve labeled "inspiratory check valve" is still at least partially open, allowing at least one therapeutic gas in at least one reservoir tube and at least one therapeutic gas entering the system through the inhalation port to enter the patient's lungs. The check valve labeled "expiratory check valve" is closed, preventing the patient from inhaling ambient air. However, a small amount of at least one therapeutic gas still remains in the proximal end of at least one reservoir tube. At this point in the patient's breathing cycle, the inspiratory phase has just ended and the expiratory phase has just begun.

[0054] In FIG. 2d, the patient has transitioned to exhalation and the check valve labeled "inspiratory check valve" is closed to prevent gas from the patient's lungs from entering at least one reservoir tube. Instead, the gas exhaled by the patient, containing the waste component of at least one therapeutic gas, is discharged from the system through the check valve labeled "exhalatory check valve." During exhalation, at least one therapeutic gas continues to enter the system through the inhalation port and refills at least one reservoir tube in preparation for the patient's next breath, the refilling operation proceeds from the proximal end of at least one reservoir tube toward the distal end at neutral pressure. The incoming fresh at least one therapeutic gas displaces the remaining residual therapeutic gas and ambient air remaining from the last inspiratory cycle toward the distal end of at least one reservoir tube to empty the remaining residual therapeutic gas and ambient air remaining from the last inspiratory cycle from at least one reservoir tube. In some embodiments, at least one reservoir tube is refilled simultaneously with the closing of the inspiratory check valve.

[0055] In some embodiments, the system of the present invention is configured to provide a safety mechanism to a patient, and the safety mechanism is configured to allow the patient to breathe ambient air when the inflow of therapeutic gas into the system is stopped according to some embodiments of the present invention.

[0056] In some embodiments, the reservoir tube is open longitudinally (e.g., to two ends of a hose) but does not follow the circumference of the shape describing its cross-section. In some embodiments, the channel is not a "U" or other open side shape that allows air to enter along the side of the reservoir.

[0057] In some embodiments, at least one therapeutic gas is a mixture of at least two gases, and the mixture of at least two gases is inhaled by a patient using a system according to some embodiments of the present invention.

[0058] Accordingly, in some embodiments illustrated in FIGS. 2a to 2d, the instantaneous amplitude ( The therapeutic gas inhaled by a patient having ) is the changed portion of the newly supplied therapeutic gas ( It contains recently stored therapeutic gas along the length of at least one reservoir tube in preparation for ) and inhalation, the reason is At least one therapeutic gas flow rate injected with an instantaneous amplitude ( This is because it significantly exceeds ) by a factor in the range of typically 2 to 5 (though not specifically limited to these values). However, since the therapeutic gas stored in the reservoir and the newly supplied therapeutic gas have equivalent compositions, any mixture of the two gases will result in a similar gas composition. Therefore, the therapeutic gas inhaled by the patient has a consistent composition throughout each inhalation cycle, and this composition is also substantially the same as the composition of the originally injected therapeutic gas.

[0059] In some embodiments, It is configured to generate a small net-outflow of at least one therapeutic gas from the distal end of at least one reservoir tube. In some embodiments, the net-outflow releases the "oldest" residual gas charge remaining after a previous inhalation of at least one therapeutic gas from at least one reservoir tube, thereby reducing or removing potential accumulation of toxic contaminants, such as NO2, within at least one reservoir tube. Furthermore, through a net-outflow that tends to flush at least one reservoir tube from one breath to the next, the patient will breathe at a substantially consistent concentration of at least one therapeutic gas. In this context, the small net-outflow is the expected total minute volume (to supply the patient's breathing needs). It is introduced by adding a margin, such as 3% to 10% of the total volume, to the value, thereby inducing the desired small net effluent flushing. In some embodiments, the measured concentration is stable within a few percent of the initial start setting and within 5% of the ideal 160 ppm concentration. In some embodiments, since the calibration accuracy of the flow meter and gas analyzer used to evaluate the concentration during treatment is about ±3% of the initiated concentration value, the measurement is a concentration that has varied to some extent relative to itself over the 30-minute treatment course. In some embodiments, the treatment varied by about 3% overall over the 30-minute course.

[0060] A system according to some embodiments of the present invention is configured to use a specific patient interface to deliver at least one therapeutic gas to a patient according to the patient's airway type. For example, in some embodiments, the patient inhales through the nose and exhales through the mouth, and in other embodiments, the patient inhales through the mouth and exhales through the nose. Additionally, for example, the patient may inhale and exhale only through the mouth or the nose.

[0061] In some embodiments, the patient is trained to inhale through one airway opening and exhale through a different airway opening. For example, the patient may be trained to inhale through the mouth and exhale through the nose.

[0062] In some embodiments, the patient interface forms a hermetic seal between the patient and the system.

[0063] In some embodiments, the patient interface is a patient interface selected from the group consisting of, but not limited to, a full face mask, a nose mask, a mouthpiece, and a pillow seal nasal cannula.

[0064] In some embodiments, the system of the present invention is configured to provide an anti-suffocation feature, the anti-suffocation feature comprising an open distal end of at least one reservoir tube placed in a breathable atmosphere of neutral pressure. In some embodiments, when the entry of at least one therapeutic gas into the system is interrupted, the system is configured to allow the patient to inhale ambient air.

[0065] In some embodiments, the system of the present invention is configured to move at least one therapeutic gas within a storage tank in a forward-backward manner, for example, in a "first in, last out" manner, such as carrying the gas back and forth within a storage tank tube without meaningful longitudinal mixing.

[0066] In some embodiments, the patient interface is maintained in place by the patient. Alternatively, in some embodiments, the patient interface is attached to the patient, for example, via an elastic strap positioned over the patient's head.

[0067] In some embodiments, at least one reservoir tube has a smooth inner surface. In some embodiments, at least one reservoir tube has a rough inner surface.

[0068] In some embodiments, at least one storage tank tube has a uniform cross-section along its length.

[0069] For example, referring to FIG. 3, in some embodiments, the present invention provides a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0070] a. At least one reservoir tube having a proximal end and a distal end and a volume greater than the patient's tidal volume,

[0071] b. At least one therapeutic gas inlet located at the proximal end of at least one storage tank tube, wherein the delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and

[0072] c. Includes a patient interface fluidly connected via a check valve to the proximal end of at least one reservoir tube, and

[0073] The patient interface is configured to form a hermetic seal between the patient and the system, and

[0074] The patient interface is a mouthpiece configured to form a hermetic seal when the patient purses their lips, and

[0075] The inspiratory check valve is configured to close when the patient exhales, and

[0076] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a rate greater than the patient's minute volume, and at least one therapeutic gas flows along at least one reservoir tube from the proximal end toward the distal end while the patient exhales, and

[0077] The check valve is configured to open when the patient inhales and to allow at least one therapeutic gas to be administered to the patient.

[0078] Additionally, in FIG. 3, the check valve can be removed, and the system is configured to allow the patient to inhale through the mouth and exhale through the nose. Thus, in an exemplary embodiment, the patient affects the functionality of the inhalation check valve.

[0079] As another example, referring to FIG. 4, in some embodiments, the present invention provides a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0080] a. At least one reservoir tube having a proximal end and a distal end and a volume greater than the patient's tidal volume,

[0081] b. At least one therapeutic gas inlet located at the proximal end of at least one storage tank tube, wherein the delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and

[0082] c. Includes a patient interface fluidly connected via a check valve to the proximal end of at least one reservoir tube, and

[0083] The patient interface is configured to form a hermetic seal between the patient and the system, and

[0084] The patient interface is a nose mask configured to form an airtight seal when placed over the patient's nose, and

[0085] The check valve is configured to close when the patient exhales, and

[0086] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a rate greater than the patient's minute volume, and at least one therapeutic gas flows along at least one reservoir tube from the proximal end to the distal end while the patient exhales, and

[0087] The check valve is configured to open when the patient inhales and to allow at least one therapeutic gas to be administered to the patient.

[0088] As another example, referring to FIG. 5a, in some embodiments, the present invention provides a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0089] a. At least one reservoir tube having a proximal end and a distal end and a volume greater than the patient's tidal volume,

[0090] b. At least one therapeutic gas inlet located at the proximal end of at least one storage tank tube, wherein the delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and

[0091] c. Includes a patient interface fluidly connected to the proximal end of at least one reservoir tube through a first check valve, and

[0092] The patient interface is configured to form a hermetic seal between the patient and the system, and

[0093] The patient interface is a face mask that covers the patient's mouth and nose, and is configured to form an airtight seal when positioned over the patient's nose and mouth.

[0094] The first check valve is configured to close when the patient exhales, and

[0095] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a rate greater than the patient's minute volume, and at least one therapeutic gas flows along at least one reservoir tube from the proximal end to the distal end while the patient exhales, and

[0096] The volume of at least one therapeutic gas introduced into at least one reservoir tube during the patient's exhalation is greater than the patient's tidal volume, and

[0097] The first check valve is configured to open when the patient inhales and to allow at least one therapeutic gas to be administered to the patient, and

[0098] The patient interface is also configured to have a second check valve, and

[0099] The second check valve is configured to close when the patient inhales and open when the patient exhales, and

[0100] The second check valve allows gas exhaled by the patient to exit the system.

[0101] In some embodiments, the system of the present invention is configured to deliver at least one therapeutic gas or at least one diagnostic gas through a mouthpiece, for example, as shown in FIG. 5b.

[0102] In some embodiments, the system of the present invention is configured to deliver a roughly constant mixture of a diagnostic gas or a therapeutic gas in combination with other breathable gases for dilution to a spontaneously breathing patient during the inspiratory portion of respiration, and

[0103] The flow of each component source gas, which is part of the final mixture, can be set to a constant rate suitable for the desired final concentration in the final intake mixture, and

[0104] Such source gases are injected individually or jointly into one or more joints and finally supplied to the proximal end of a reservoir, the reservoir provides a temporary storage place for any inflow not required by patient inspiration, and such a reservoir has a high length-to-cross-sectional aspect ratio that effectively carries gases along the length of the reservoir without excessive mixing of gases in the longitudinal flow direction,

[0105] The system includes means for attaching the proximal end of the reservoir to the patient's airway so that the patient can inhale freely from the convergence of the proximal end of the reservoir and the infusion source gases, but prevents any patient exhalation from flowing backward into the reservoir.

[0106] The distal end of the above-mentioned channel reservoir is open to a neutral pressure region where substantially clean, breathable air exists.

[0107] In some embodiments, the sum of individual constant source flow rates exceeds the time-averaged patient inspiratory flow, and consequently, a net outflow of gas exists at the distal end of the reservoir. This excess is formally " It is represented as ".

[0108] In some embodiments, the net outflow or inflow of gas at the distal end of the reservoir is monitored to ensure that ambient air is not normally and effectively inhaled by the patient, and in this case, officially " It is represented as ". In this case as well, at least one therapeutic gas is required to induce patient treatment, but the open distal end of at least one reservoir tube retains a suffocation prevention feature.

[0109] In some embodiments, the volume of the reservoir is slightly larger than the patient's normal tidal volume.

[0110] In some embodiments, the sum of individual constant source flow rates exceeds the time-averaged patient inspiratory flow rate, and consequently, a net outflow of gas exists at the distal end of the reservoir.

[0111] In some embodiments, the sum of individual constant source flow rates exceeds the time-averaged patient inspiratory flow rate by a small fraction, and consequently, a net outflow of gas exists at the distal end of the reservoir, flushing the reservoir of older gas.

[0112] In some embodiments, the net outflow or inflow of gas at the distal end of the storage tank is monitored by a flow meter.

[0113] In some embodiments, the source gas for therapeutic or diagnostic purposes contains a higher concentration of nitric oxide than required for effective patient delivery, and such gas is diluted with a diluent gas and delivered by the device at a fixed concentration selected between 0.5 ppm and 400 ppm, with the remainder being air or oxygen-rich air.

[0114] In some embodiments, to achieve a fixed concentration of two or more target gases during the same patient inhalation, two or more therapeutic or diagnostic gases are mixed through additional injection points.

[0115] In some embodiments, means for preventing backflow of any exhaled patient breath into at least one reservoir tube is provided by a directional flow check valve located between the patient's airway and the connection between the proximal outlet of the reservoir tube and the source gas injection point.

[0116] In some embodiments, means of preventing backflow of the patient's exhaled breath into the reservoir is achieved by a patient trained in a breathing pattern in which the patient inhales selectively through only one of the mouth or nose rather than both, and then exhales selectively through the other rather than both.

[0117] In some embodiments, the reservoir is formed as a single long channel having a sufficient volume equal to or exceeding the patient's tidal volume but a sufficient cross-section that results in low respiratory effort.

[0118] In some embodiments, the gas stored in at least one reservoir tube is required during the patient's inhalation so that it is not exhaled before the patient's inhalation ends. Sufficient injection flow to supply sufficient flow ( Only when ) is provided, the storage tank may be smaller than the patient's tidal volume.

[0119] In some embodiments, the reservoir is formed of a plurality of parallel flow channels, each providing a high length-to-cross-sectional aspect ratio, and each individual channel carries any gas entering into the channel in such a way that the parallel ensemble provides a total volume sufficient to equal or exceed the patient's tidal volume, while suppressing longitudinal mixing of the gas.

[0120] In some embodiments, the present invention is a delivery device configured to provide a breathable mixture of gases comprising a therapeutic gas or a diagnostic gas, wherein a constant ratio of the components is desired during inhalation by a spontaneously breathing patient, and one or more constant flow supplies of the therapeutic or diagnostic source gases and the diluent gases are injected into one or more adjacent gas ports disposed at the proximal end of a reservoir, and

[0121] The storage tank is formed with one or more parallel channels that are longer than their cross-sectional dimensions, and

[0122] The distal end of the reservoir is open to a source of breathable gas at atmospheric pressure, and

[0123] The net volume of the reservoir is equal to or greater than the patient's exhaled tidal volume, and

[0124] The total sum of the injected flows of therapeutic gas and diluent gas is equal to or exceeds the patient's minute volumetric flow rate, and

[0125] The proximal end of the reservoir and the gas injection port are connected to a conduit that connects the patient's airway to an airtight seal.

[0126] In some embodiments, the patient's airway is separated from the proximal end of the reservoir and the gas injection point by a directional flow check valve.

[0127] In some embodiments, any injected flow exceeding the patient's fractional volume is discharged from the distal end of the reservoir without restriction.

[0128] In some embodiments, one of the injected constant gas streams carries a fixed ratio of nitric oxide, said nitric oxide in the injection stream is present at a higher concentration than required for patient treatment, and the final mixed nitric oxide concentration for patient treatment can be adjusted in the range of 0.5 ppm to 400 ppm, which is delivered to a dilution balance of air or oxygen-rich air.

[0129] In some embodiments, the diagnostic gas comprises, for example, but not limited to, a tracer gas including helium, hydrogen, sulfur hexafluoride, carbon monoxide, or a combination thereof.

[0130] In some embodiments, the device has a flow port having an outward flow check valve to discharge the patient's exhaled breath.

[0131] In some embodiments, the distal end of the storage tank is equipped with a flow monitor that allows the net flow of gas into and out of the distal end of the storage tank to be evaluated. In some embodiments, the distal flow evaluation may be performed automatically, manually, or any combination thereof.

[0132] In some embodiments, the device of the present invention further comprises, but is not limited to, at least one alarm, at least one monitor, or any combination thereof, including those related to component gas flow, gas concentration, total flow, total volume, contamination level, humidity, temperature, time, or any combination thereof.

[0133] In some embodiments, at least one monitor is configured to notify at least one entity [e.g., a caregiver (e.g., doctor, nurse, parent, etc.), a medical provider, an aware patient, etc.] when at least one of the following conditions is satisfied: that the sum of individual constant source flows does not exceed the time-averaged patient inspiratory flow; that a net outflow or inflow of gas at the distal end of the reservoir allows the patient to inhale ambient air; that the volume of the reservoir is depleted during the normal inspiratory process by the patient; that the sum of individual constant source flows does not exceed the time-averaged patient inspiratory flow by a small fraction; that a fixed concentration is not within a predetermined range set as part of the intended treatment; that patient respiratory reflux is detected; that the total duration of the treatment is shorter or longer than a prescribed time by a small predetermined margin; or that any combination of these conditions is satisfied. In some embodiments, at least one alarm is configured to alert at least one entity (e.g., caregiver, medical provider, etc.) when at least one monitor identifies at least one of the conditions described herein.

[0134] In some embodiments, the device of the present invention may be used to treat a single subject or may be reused in turn for multiple subjects. In some embodiments, treatment may be performed in a hospital setting or outside of a hospital setting (e.g., but not limited to, a home, airport, shopping center, public health clinic, isolation facility, etc.).

[0135] In some embodiments, an exhaust collection conduit may be required as shown in FIG. 6 to transport the exhaled gas to an area for analysis, exhaust, treatment, or decontamination.

[0136] In some embodiments, the composition of the exhaled gas may be analyzed to evaluate the patient absorption of components of a therapeutic or diagnostic tracer gas, or alternatively, residual components of a therapeutic gas. In some embodiments, the exhaled gas may contain contaminants that require treatment before entering the environment. For example, the exhaled residual components and contaminants may include gases such as unabsorbed NO, NO2 generated as a byproduct of NO, infectious particulates, or radioactive materials.

[0137] At least one storage tank tube

[0138] The typical tidal volume of a human patient is in the body weight range of 3 ml / kg (e.g., children, but not restricted) to 5 ml / kg (e.g., adults, but not restricted). In some embodiments, the typical tidal volume of a human patient is in the range of 50 mL (e.g., children, but not restricted) to 750 mL (e.g., adults, but not restricted).

[0139] In some embodiments, at least one reservoir tube is configured to maintain a sufficient volume of at least one therapeutic gas to support flow during patient inspiration. In some embodiments, the sufficient volume of at least one therapeutic gas is equal to the patient's tidal volume. In some embodiments, the sufficient volume is equal to 100% + x% of the patient's tidal volume, where x% is a fraction of the tidal volume (e.g., 10%, though not limited to), so in this case, the reservoir is sized to store 110% of the patient's tidal volume. In some embodiments, the length of at least one reservoir tube and consequently the volume is intended to be adjusted to suit the characteristics of a specific patient. In some embodiments, the injected flow is intended to be adjusted to suit the characteristics of a specific patient. In some embodiments, the volume of at least one reservoir tube and the injected flow ( Both are intended to be adjusted to suit the specific characteristics of the patient.

[0140] In some embodiments, at least one reservoir tube comprises a tube having a smooth inner wall and a high length-to-cross-sectional dimension ratio. In some embodiments, at least one reservoir tube has a sufficiently round shape and an equivalent inner diameter, the equivalent inner diameter being a small fraction of the reservoir length (e.g., 0.5% to 5% of the reservoir length, though not limited thereto).

[0141] Therefore, as an example, for a 100 kg patient with a tidal volume of 500 mL using at least one reservoir tube with an inner diameter of 19 mm, the length of at least one reservoir tube holding 550 mL (e.g., a reservoir volume margin 10% higher than the tidal volume) can be calculated as follows:

[0142] sign explanation unit D R Inner diameter of the storage tank tube [mm] A R Cross-sectional area of ​​the storage tank tube [mm 2 ] L R Length of the storage tank tube [m] V R Internal volume of the storage tank tube [liter]

[0143]

[0144] Therefore, a 1.76-meter reservoir tube with an inner diameter of 19 mm will provide an internal reservoir volume of 500 ml. To create a 10% margin of error, the length must be increased to 1.94 meters (which increases the reservoir to 550 mL).

[0145] In some embodiments, multiple tubes operating in parallel may form a reservoir, and the total length may be shorter while still retaining a sufficient volume of at least one therapeutic gas. This arrangement of parallel tubes may include two parallel tubes or extend to many parallel tubes of smaller diameter. Examples of these embodiments are illustrated in FIGS. 7 through 9. In these examples, each tube provides a high length-to-cross-sectional dimension ratio on its own right, but the assembly is generally shorter.

[0146] Therefore, as an example, with a tidal volume of 500 ml and a total reservoir volume of 510 mL (V RFor a 100 kg patient using at least one reservoir tube with an inner diameter of 19 mm configured for ) (in this example, this provides a 2% margin relative to the tidal volume), if two or more reservoir tubes can be used, the reservoir configuration can be determined as follows:

[0147] The length of the tube is a function of the number of tubes used and the inner diameter of each tube. For example, the desired storage tank volume (V R ) is 510 mL, the number of similar round tubes (N) is 30, and the inner diameter (D) is 6 mm. tube When each tube having ) is selected, the length of each small tube is determined as follows.

[0148]

[0149]

[0150] Therefore, as shown in Fig. 9, a "straw bundle" configuration can be formed.

[0151] In some embodiments, the rate at which a sufficient amount of at least one therapeutic gas is introduced into at least one reservoir tube is configured to introduce a sufficient amount during the exhalation phase of the patient's breathing cycle. In some embodiments, the rate at which a sufficient amount of at least one therapeutic gas is introduced into at least one reservoir tube is configured to introduce a sufficient amount within about 2 seconds when the patient breathes 30 times per minute.

[0152] In some embodiments, the reservoir volume must be equal to or slightly exceed (e.g., up to 10%) the patient's tidal volume. In some embodiments, the total flow rate of the incoming therapeutic gas must be equal to or slightly exceed the patient volume. In an exemplary embodiment, the patient's breathing pattern is used to guide the system of the present invention in which the patient has a tidal volume of 500 mL, the patient breathes 30 times per minute, and the reservoir capacity is 510 mL. Patient minute volume ( ) is (500 mL / breath x 30 breaths / min), which is equivalent to 15 LPM (liters per minute). Therefore, It should be set to a very slightly increased level of (510 mL x 30 breaths / min), that is, 15.3 LPM.

[0153] The introduction of at least one therapeutic gas into at least one reservoir tube must be performed at a speed that does not induce turbulence, but must cause bulk flow of the gas along the length of the reservoir. In some embodiments, the gas introduction is performed at a speed in which the flow of at least one therapeutic gas is laminar. Accordingly, in some embodiments, the internal cross-sectional dimensions of at least one reservoir tube and / or the internal surface texture of at least one reservoir tube are selected so that the flow of at least one therapeutic gas can maintain laminar flow along the length of the reservoir.

[0154] For example, the Reynolds number indicates the laminar or turbulent characteristics of gas flow. A Reynolds number less than 2,300 is considered laminar flow. For flow within pipes or tubes, the Reynolds number (Re) is generally defined as follows.

[0155]

[0156] sign explanation unit D H Hydraulic diameter (equivalent round pipe diameter) [m] Volumetric flow rate [m 3 / sec] A Pipe cross-sectional area [m 2 ] v Average velocity of the fluid [m / sec] μ fluid dynamic viscosity [kg / (m·s)] υ kinematic viscosity (=μ / ρ) [m 2 / sec] ρ Fluid density [kg / m 3 ]

[0157] Accordingly, in this exemplary embodiment, a 19 mm reservoir tube and an estimated flow of 16 LPM within the reservoir tube (from before (rounded to the nearest integer) provides the following results during tank filling:

[0158]

[0159] Therefore, in this example, if the reservoir fill rate is 16 LPM, a Re value is obtained in a laminar flow state. In some embodiments, the flow of at least one therapeutic gas within at least one reservoir tube during the inhalation phase is also still laminar. As an example, assuming the patient breathes at a peak inhalation flow rate of about 40 LPM (inhaling 500 mL in about 0.75 seconds and referring to the circulating flow pattern in Fig. 1) and follows a calculation similar to the previous example, the demand for the reservoir will be about 24 LPM during inhalation (i.e., the 40 LPM inhalation flow is less than 16 LPM directly supplied by the infusion flow of the therapeutic gas). Thus, the induced reservoir flow rate is associated with a Reynolds number of about 1730, which is still within the range considered to be laminar flow.

[0160] In some embodiments, at least one reservoir tube is coiled. Flow within a coiled tube tends to remain viscous at higher flow values ​​for an equivalent Re value compared to a straight tube. Curvature-induced helical vortices (Dean vortices) tend to suppress the onset of turbulence and delay the transition from laminar flow. The critical Reynolds number (Re) that describes the transition from laminar to turbulent flow cr ) can be calculated as follows:

[0161]

[0162] sign explanation unit Re cr Critical Reynolds number doesn't exist D R Inner diameter of the storage tank tube [mm] R coil coil curvature radius [mm]

[0163] An example of an embodiment of the system of the present invention having at least one coil-shaped storage tank tube is illustrated in FIG. 10.

[0164] In some embodiments, the flow rate and flow direction within at least one storage tank tube can be monitored to evaluate the operation of the storage tank.

[0165] In some embodiments, at least one storage tank tube further includes a flow meter at the distal end, as shown in FIG. 21, for example.

[0166] In some embodiments, a system configured to administer at least one therapeutic gas to a patient is also configured to monitor the flow of gas through the proximal end of at least one reservoir tube by repositioning the flow meter in FIG. 21.

[0167] In some embodiments, a system configured to administer at least one therapeutic gas to a patient is also configured to monitor at least one therapeutic gas introduced into a system configured to administer at least one therapeutic gas to a patient, as illustrated in FIGS. 10 and 20, for example.

[0168] In some embodiments, at least one reservoir tube further includes a sampling port at the proximal end.

[0169] In some embodiments, a system configured to administer at least one therapeutic gas to a patient is also configured to emit an alarm when a monitored value of either the concentration or the flow rate of at least one therapeutic gas deviates from a threshold value.

[0170] In some embodiments, a system configured to administer at least one therapeutic gas to a patient is also configured to change the flow rate and / or the concentration of at least one therapeutic gas when a monitored value of the concentration of component gases or the flow rate in at least one therapeutic gas deviates beyond a threshold value.

[0171] In some embodiments, the proximal end of at least one reservoir tube has two or more inlets. In some embodiments, a therapeutic gas may be introduced into the system through one inlet, and a diluent gas may be introduced into the system through a second inlet. In some embodiments, the therapeutic gas and the diluent gas may be mixed before being introduced into the system. FIGS. 11 through 17 illustrate embodiments in which the therapeutic gas and the diluent gas are mixed before being introduced into the system. FIGS. 18 through 20 illustrate embodiments in which the therapeutic gas and the diluent gas are mixed before being introduced into the system. FIG. 21 illustrates an embodiment in which at least one reservoir tube is also configured to include a flow meter at the distal end.

[0172] FIG. 22 illustrates a reservoir device described in some embodiments of the present invention, wherein the reservoir is configured to operate as part of a therapeutic gas delivery system capable of periodically determining average injection flow requirements, and such periodic determination is based on a flow measurement signal derived from a flow meter in response to the average flow and flow direction within the reservoir, and

[0173] The determination of fluid requirements is performed in a time frame longer than one breath but shorter than thirty breaths, and

[0174] The total flow of injected therapeutic gas is periodically adjusted based on a recently determined pattern of average infusion flow requirements, and said adjustment is performed simultaneously with maintaining individual component gas flow rates at a predetermined fixed rate, so that the net flow in the reservoir is maintained averagely in the outflow direction so that the reservoir is regularly flushed with fresh therapeutic gas. In some embodiments, some embodiments of the system of the present invention respond to long-term fluctuations in the patient's respiration without the need to interrupt or adjust the flow during individual breathing cycles. In some embodiments, flow adjustment is performed by a system operator (e.g., an automated device that implements this function through analog, digital, or computational means as known in the art). In some embodiments, the system is configured to monitor reservoir outflow and adjust the total infused therapeutic gas flow in response to natural changes in the patient's breathing pattern.

[0175] In some embodiments, at least one reservoir tube is also configured to minimize the effort required by the patient to perform inhalation, exhalation, or both inhalation and exhalation. In some embodiments, the diameter of at least one reservoir tube is configured to minimize the effort required by the patient to perform inhalation, exhalation, or both inhalation and exhalation.

[0176] In some embodiments, at least one reservoir tube is also configured to minimize the effort required by the patient to inhale. In some embodiments, the diameter of the outlet and the diameter of the reservoir tube are configured to minimize the effort required by the patient to exhale.

[0177] At least one therapeutic gas

[0178] In some embodiments, at least one therapeutic gas is selected from the group consisting of oxygen, nitric oxide, carbon monoxide, and nitrous oxide. In some embodiments, at least one therapeutic gas comprises aerosolized particles, microparticles, nanoparticles, or any combination thereof, and the aerosolized particles, microparticles, nanoparticles, or any combination thereof are stable in an aerosol suspension for a period corresponding to the therapeutic requirements, typically not limited to at least one day.

[0179] In some embodiments, the system of the present invention does not include a scrubbing element (a mechanism configured to remove some of the therapeutic gases, such as but not limited to helium gas, NO, oxygen, etc.).

[0180] In some embodiments, the system of the present invention does not include a scrubbing element (a mechanism configured to remove a portion of a therapeutic gas, e.g., but not limited to, a diagnostic gas, e.g., a tracer gas).

[0181] In some embodiments, the system of the present invention does not include a mechanism used to control, throttle, gate, or any combination thereof the flow of therapeutic gas toward a patient after an initial flow rate has been established.

[0182] In some embodiments, the system of the present invention includes a mechanism used to control, throttle, gate, or any combination thereof the flow of a therapeutic gas toward a patient after an initial flow rate has been established.

[0183] In some embodiments, at least one therapeutic gas is diluted before being introduced into the system of the present invention. However, in some embodiments, at least one therapeutic gas is diluted when the gas is introduced into the system of the present invention.

[0184] In some embodiments, the gas used to dilute at least one therapeutic gas contains oxygen. In some embodiments, the gas used to dilute at least one therapeutic gas contains oxygen and an inert gas such as nitrogen. In some embodiments, the gas used to dilute at least one therapeutic gas is compressed air.

[0185] In some embodiments, at least one therapeutic gas is administered along with supplemental oxygen.

[0186] In some embodiments, at least one therapeutic gas and at least one gas used to dilute the therapeutic gas are stored in a compressed gas cylinder. In some embodiments, the gas is distributed using a gas flow control device known in the art, such as, but not limited to, a rotameter, a mass flow meter, and a positive displacement pump.

[0187] In some embodiments, the therapeutic gas is a mixture of gases, and the therapeutic gas is mixed with breathable air.

[0188] In some embodiments, the system of the present invention is also configured to reduce the possibility of NO2 formation by reducing the "dead volume" in the patient connection between the patient's airway and the inspiratory check valve.

[0189] In some embodiments, nitric oxide is stored in a cylinder containing a medical pharmaceutical gas and dispensed from the cylinder.

[0190] In some embodiments, a patient is treated using the system of the present invention through the method disclosed in U.S. Patent Application No. 2015 / 0044305. In some embodiments, the treatment method further comprises the step of monitoring one or more on-site and off-site parameters such as biosignals, methemoglobin levels, lung function parameters, blood chemistry and hematological parameters, blood coagulation parameters, inflammation marker levels, liver and kidney function parameters, and vascular endothelial activation parameters.

[0191] In some embodiments, the patient is treated using the system of the present invention through the method disclosed in International Patent Application Publication No. 2013132497 A1.

[0192] In some embodiments, at least one storage tank tube further includes a flow meter at the distal end.

[0193] In some embodiments, at least one reservoir tube further includes a sampling port at the proximal end.

[0194] In some embodiments, the present invention is a system configured to administer at least one therapeutic gas to a patient, wherein the system comprises:

[0195] a. At least one reservoir tube having a proximal end and a distal end, having a volume within ±20% of the patient's tidal volume,

[0196] b. at least one therapeutic gas inlet located at the proximal end of at least one reservoir tube, wherein a delivery tube is connected to at least one therapeutic gas inlet and at least one therapeutic gas source, and the distal end of the reservoir is open to a source of gas breathable at atmospheric pressure, and

[0197] c. Includes a patient interface fluidly connected via a check valve to the proximal end of at least one reservoir tube, and

[0198] The patient interface is configured to form a hermetic seal between the patient and the system, and

[0199] The inspiratory side of the check valve is configured to close when the patient exhales, and

[0200] At least one therapeutic gas is introduced into at least one reservoir tube from the proximal end through at least one therapeutic gas inlet at a flow rate sufficient to prevent all of the at least one therapeutic gas stored in at least one reservoir tube from being consumed during a patient's normal single inhalation, and

[0201] At least one therapeutic gas flows along at least one reservoir tube from the proximal end to the distal end while the patient exhales, and

[0202] The inspiratory side of the check valve is configured to open when the patient inhales, and

[0203] The intake side of the check valve is configured to allow at least one therapeutic gas to be administered to the patient.

[0204] The present invention is not limited but is also illustrated by the following examples.

[0205] Examples

[0206] Example 1: Effect of the radius of the coil of at least one reservoir tube in laminar flow and the concentration of nitric oxide in at least one reservoir tube

[0207] Experiments were conducted using 160 ppm of nitric oxide introduced into a coiled reservoir tube having the coil radius shown in the table below. After the gas reciprocated back and forth in the reservoir tube simulating a breathing cycle, the concentration of nitric oxide in the reservoir tube was compared to the ideal value of 160 ppm.

[0208] R coil (mm) NO concentration (ppm) Comments 145 160 N / A 120 161 N / A 100 162 This R coil In this, it was observed that the cross-section of the storage tank tube changed to an elliptical shape. 180 162 N / A 210 162 N / A

[0209] No significant changes were observed in NO concentration. It was confirmed that a coil radius of approximately 145 mm can be used without the reservoir tube being noticeably twisted or deformed in cross-section. Assuming a coil radius of 145 mm is used, the critical Reynolds number (Re cr ) will be approximately 2100. This nominal Re cr Given the value, laminar flow must be maintained throughout the breathing cycle.

[0210] Publications cited throughout this specification are incorporated herein by reference in their entirety.

Claims

Claim 1 A device configured to administer at least one therapeutic gas, including nitric oxide, to a patient, comprising: a. at least one reservoir tube having a proximal end and a distal end, wherein the distal end is configured to be open to the surrounding environment so that gas can move unimpeded through the distal end, and the at least one reservoir tube has a volume greater than the tidal volume of the patient's breath; b. at least one therapeutic gas inlet located at the proximal end of the at least one reservoir tube, wherein a delivery tube is connected to the at least one therapeutic gas inlet and at least one therapeutic gas source; c. a patient interface fluidly connected to the proximal end of the at least one reservoir tube via an inspiratory check valve, wherein the patient interface is configured to form a hermetic seal between the patient and the device; d. a device comprising a sampling port located distal to the inspiratory check valve and proximal to the at least one therapeutic gas inlet. Claim 2 A device according to claim 1, further comprising an exhalation check valve. Claim 3 A device according to claim 1, wherein the patient interface is selected from a full face mask, a nose mask, a mouthpiece, and a pillow seal nasal cannula. Claim 4 A device according to claim 1, wherein the diameter of at least one reservoir tube is also configured to minimize the effort required by the patient to inhale. Claim 5 A device according to claim 1, further comprising an outlet, wherein the diameter of the outlet is configured to minimize the effort required by the patient to exhale. Claim 6 The device according to claim 1, wherein the device is configured to monitor at least one parameter of the flow of at least one therapeutic gas through the proximal end of the at least one storage tank tube, and the at least one parameter includes concentration, flow rate, flow volume, contamination level, or any combination thereof. Claim 7 A device according to claim 1, wherein the at least one storage tank tube further comprises a flow meter at the distal end. Claim 8 A device according to claim 1, wherein the sampling port is located at the proximal end of the at least one storage tank tube. Claim 9 A device according to claim 1, wherein the sampling port is configured to monitor the at least one therapeutic gas delivered to a patient, to specify the at least one therapeutic gas delivered to a patient, or to perform both. Claim 10 In paragraph 9, the device wherein the gas is specified by contents, contamination level, flow rate, flow volume, concentration, or any combination thereof. Claim 11 The device according to claim 1, wherein the device is also configured to emit an alarm when any one of the monitored values ​​of the concentration, flow rate, or any combination thereof of the at least one therapeutic gas deviates from a threshold value. Claim 12 The device according to claim 1, wherein the device is also configured to change the concentration, flow rate, or any combination thereof of the at least one therapeutic gas. Claim 13 A device according to claim 1, wherein the concentration of nitric oxide in a mixture of oxygen and nitrogen is 160 ppm. Claim 14 A device according to claim 1, wherein the nitric oxide is present at a concentration of 0.5 ppm to 400 ppm. Claim 15 A device according to claim 1, further comprising a second check valve, wherein the second check valve is configured to be closed while the patient inhales and open while the patient exhales, and wherein the device is configured such that the second check valve exhausts the gas exhaled by the patient.

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