Fluid valve

Abstract

A fluid device for a mechanical respirator has an inlet configured to receive fluid from a pressurized source. The device includes a device nozzle having a device nozzle axis, a device nozzle length, and a device nozzle width. The device includes at least one port having an opening to an environment external to the device. The device is configured such that an ambient fluid enters the device through the port and mixes with a source fluid from the inlet to define a diluted fluid mixture. The device is further configured such that the diluted fluid mixture enters the device nozzle.

Description

[0001] priority

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 328,599 filed on April 7, 2022 and U.S. Provisional Patent Application No. 63 / 337,997 filed on May 3, 2022, the disclosures of which are incorporated herein by reference in their entireties. Technical Field

[0003] Exemplary embodiments of the present invention relate generally to fluidic valves, and more particularly, exemplary embodiments relate to mechanical ventilation using fluidic valves. Background Art

[0004] Mechanical ventilation is an essential component of critical care delivery for patients and can have catastrophic effects when it is not deployed correctly or safely. The challenge of responding to the recent global pandemic caused by the coronavirus COVID-19 has revealed a critical shortage of mechanical ventilators due to an unexpected surge in patients with life-threatening respiratory failure. In the United States, for example, there is an urgent and significant need for effective, inexpensive, and simple-to-use ventilators and resuscitators. Such ventilators or resuscitators may also be needed in future regional epidemics or in low-resource settings. Summary of the invention

[0005] According to one embodiment of the present invention, a fluid device for a mechanical ventilator has an inlet configured to receive a fluid from a pressurized source. The valve includes a device nozzle having a device nozzle axis, a device nozzle length, and a device nozzle width. The device includes at least one port having an opening to an environment outside the device. The device is configured so that an ambient fluid enters the device through the port and mixes with a source fluid from the inlet to define a diluted fluid mixture. The device is further configured so that the diluted fluid mixture enters the device nozzle.

[0006] In some embodiments, the fluid device may include multiple ports. Each port may have a closure. The closure may be adjustably opened or closed. The device may be configured so that closing the port biases the fluid flow through the device in a specific direction. In some embodiments, the fluid leaving the inlet is biased toward the outlet side of the nozzle. In some embodiments, the fluid leaving the inlet is biased toward the exhaust port side of the nozzle. In addition, PIP and PEEP can be selectively adjusted by closing and / or opening one or more ports.

[0007] In addition, the device can achieve a desired flow rate through the device nozzle that is higher than the flow rate through the inlet. The port can allow air outside the device to be entrained into the device. The entrained air can dilute the air from the fluid source through the inlet. The port can also serve as a safety exhaust.

[0008] In some embodiments, the inlet and the device nozzle are formed as a single piece. Alternatively, the inlet and the device nozzle may be formed separately. The inlet and the device nozzle may be connected via a fluid conduit. The nozzle port may be integral with the inlet.

[0009] Various embodiments include a dilution nozzle having a diameter. The diameter can narrow from the proximal end to the distal end of the dilution nozzle. The dilution nozzle can be part of a dilution connector that is separate from the device. The dilution connector can also include a dilution port. The dilution connector can be connected to the device using a fluid conduit. Ambient air can be used to dilute the fluid from the fluid source using one or more dilution ports. In addition, one or more dilution ports can be used to exhaust air to the outside of the device. The diluted fluid can flow toward the patient outlet. In various embodiments, the fluid device is configured to oscillate the fluid flow between the patient outlet and the exhaust port.

[0010] In addition, the device may include a nozzle switcher configured to switch the device between a first configuration in which the device nozzle is fluidly coupled to the port and a second configuration in which the device nozzle is fluidly coupled to the port. The nozzle switcher may switch the device by rotating or sliding. The axis of rotation of the switcher may be offset from the central axis of the device. In the first configuration, the device is fluidly coupled to a ventilation channel having an opening to the port. In the second configuration, the device is fluidly coupled to a channel having a blocking element for the port.

[0011] In various embodiments, the fluid device may include a fluid expansion zone away from the inlet. The fluid expansion zone tapers downward to a nozzle having a nozzle axis, a nozzle length, and a nozzle width. The transition surface is part of a patient fluid path leading to an outlet. The outlet is directly or indirectly connected to the patient. The device also has a stepped surface that is part of a second fluid path leading to an exhaust port. A splitter separates the first fluid path and the second fluid path. The splitter is asymmetric relative to the nozzle axis. The inlet, nozzle, and outlet share a coplanar fluid path.

[0012] According to another embodiment, a method provides mechanical ventilation to a patient. The method connects a fluid device between a patient's breathing circuit and a pressurized source. The fluid device has an inlet configured to receive a fluid from a pressurized source. The device also has a fluid expansion zone away from the inlet. The fluid expansion zone leads to a nozzle having a nozzle axis, a nozzle length, and a nozzle width. The transition surface is part of a patient fluid path leading to an outlet. The outlet is configured to be connected to a patient or a patient's breathing circuit. The stepped surface is part of a second fluid path leading to an exhaust port. A splitter separates a first fluid path and a second fluid path. The splitter is asymmetric with respect to the nozzle axis. The inlet, nozzle, and outlet share a coplanar fluid path. The method also provides an air flow to the inlet of the device. The air flowing out of the outlet flows to the patient. The air flow out of the device generates a target PIP between about 18cmH20 and 30cmH20 in the patient circuit. Then, after reaching the target PIP, the air flows out of the exhaust port until a PEEP between about 6cmH20 and 14cmH20 is achieved in the patient circuit. The step of causing air to flow out of the outlet and the step of causing air to flow out of the exhaust port define a respiratory rate between about 10 breaths per minute and about 30 breaths per minute. Some embodiments may define a respiratory rate between about 16 breaths per minute and about 30 breaths per minute. Thus, in one or more examples, the geometry of the device may be at least partially effective to provide PIP, PEEP, and respiratory rate.

[0013] In some embodiments, the fluid expansion zone is configured to render the flow turbulent.The tidal volume delivered to the patient from the device is between about 200 ml and about 500 ml, or between about 220 ml and about 465 ml.

[0014] The transition surface leading to the outlet may have a radius of curvature. In some embodiments, the transition surface is stepped. Alternatively or additionally, the transition surface may be flat. In some embodiments, the surface leading to the exhaust port may be stepped. In some embodiments, the device may have multiple exhaust ports.

[0015] The device may be configured such that the flow diverter biases the fluid flow towards the outlet. The fluid flow path leading to the exhaust port may be asymmetric to the fluid flow path leading to the outlet. The fluid flow path of the device may have a rectangular cross-section.

[0016] In some embodiments, the device is configured to provide an IE ratio between about 1.5 and 2.0. The device can receive air input at a pressure between about 3 psi and about 5 psi. Various embodiments can be used to control ventilation or support patient ventilation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Those skilled in the art should more fully appreciate the advantages of the various embodiments of the present invention from the following "Detailed Description" discussed with reference to the drawings summarized immediately below.

[0018] Figure 1A An external view of a fluidic device according to an exemplary embodiment of the present invention is schematically shown.

[0019] Figure 1B Schematically shows Figure 1A A cross-sectional view of the device rotated 90 degrees about the longitudinal axis of the device.

[0020] Figure 1C Schematically shows Figure 1B An enlarged view of a portion of the device identified in FIG.

[0021] Figure 1D Schematically shows Figure 1B An enlarged view of a portion of the device identified in FIG.

[0022] Figure 1E Schematically shows a schematic diagram of a circuit diagram according to an exemplary embodiment with a scaled example. Figures 1A to 1D device.

[0023] Figure 1F An internal view of a fluid flow path of a device according to an exemplary embodiment is schematically shown.

[0024] Figure 2 An apparatus according to an exemplary embodiment of the invention is schematically shown.

[0025] Figure 3 The flow of fluid through a device according to an exemplary embodiment of the invention is schematically shown.

[0026] Figure 4A An apparatus according to an exemplary embodiment of the invention is schematically shown.

[0027] Figure 4B Schematically shows the Figure 4A Airflow characteristics and breathing parameters achieved by an exemplary device.

[0028] Figure 5A An apparatus according to an exemplary embodiment of the invention is schematically shown.

[0029] Figure 5B Schematically shows the Figure 5A Airflow characteristics and breathing parameters achieved by an exemplary device.

[0030] Figure 6Various performance parameters achieved using an apparatus according to an exemplary embodiment are schematically illustrated.

[0031] 7A to 7C The effect of a device according to an exemplary embodiment of the present invention on a PIP is schematically illustrated.

[0032] FIG. 8A to FIG. 8B The effect of a device according to an exemplary embodiment of the invention on PEEP is schematically illustrated.

[0033] Fig. 9 The effect of an apparatus according to an exemplary embodiment of the present invention on IE ratio settings is schematically illustrated.

[0034] Fig.10 The airway flow and airway pressure waveforms when the device is used according to an exemplary embodiment of the present invention are schematically shown.

[0035] FIG. 11A to FIG. 11C An apparatus according to an exemplary embodiment of the invention is schematically shown.

[0036] FIG. 12A to FIG. 12C Various configurations of biasing air flow through the inlet of a device according to exemplary embodiments of the invention are schematically shown.

[0037] Fig.13 An external view of a device according to an exemplary embodiment of the present invention is schematically shown.

[0038] Fig.14 An alternative embodiment of the device according to the illustrative embodiment is schematically shown.

[0039] FIG. 15A to FIG. 15C Schematically shows a Fig.14 Dilution connector.

[0040] Fig.16 A cross-sectional view of an alternative embodiment of a device according to an exemplary embodiment is schematically shown.

[0041] Fig.17 A cross-sectional view of an alternative embodiment of a device according to an exemplary embodiment is schematically shown.

[0042] 18A to 18C Details of a nozzle switcher according to an exemplary embodiment are schematically shown.

[0043] Fig.19 A mechanical ventilation process using a device according to an exemplary embodiment of the present invention is shown. DETAILED DESCRIPTION

[0044] In an exemplary embodiment, a fluid device (also referred to as a fluid valve) is configured to provide safe and accurate ventilation to a patient. The fluid valve can be located between a patient's breathing circuit and a source of pressurized gas and / or a mechanical ventilator. In some embodiments, the fluid valve can be integrated in a ventilator, a resuscitator, a bag-valve-mask, etc. Additionally or alternatively, the fluid valve is interfaced between a patient's breathing circuit and a mechanical ventilator (e.g., a ventilator, a bag-valve-mask). The fluid valve is configured to provide a safe and accurate lung protection ventilation performance characteristic to a patient. The valve includes a coplanar fluid flow path defined by an inlet, a nozzle, and an outlet. The valve geometry is configured to generate a desired PIP, PEEP, and RR for the patient. In various embodiments, the valve automatically converts the patient from inspiration (also referred to as oscillation) to exhalation. In addition, the valve includes a dilution port, which is configured to dilute the fluid source passing through the device toward the patient's outlet. The details of the exemplary embodiment are discussed below.

[0045] Figures 1A to 1D A view of a fluid valve 10 according to an exemplary embodiment of the present invention is schematically shown. Figure 1A (Upper right) schematically shows an external view of a fluid valve 10 according to an exemplary embodiment of the present invention. Figure 1B Schematically shows Figure 1A A cross-sectional view of the valve 10 rotated 90 degrees about the longitudinal axis of the valve 10 . Figure 1C Schematically shows Figure 1B An enlarged view of the portion L of the valve 10 identified in FIG. Figure 1D Schematically shows Figure 1B An enlarged view of the portion M marked in FIG.

[0046] refer to Figure 1A and Figure 1B , the valve 10 has an inlet 12 configured to receive a supply of fluid (e.g., pressurized oxygen), an outlet 14 leading to a patient, and an exhaust port 16. In use, the valve 10 diverts a flow of fluid (e.g., air) from the outlet 14 to the exhaust port 16, and vice versa. As will be described in more detail below, various embodiments are configured to provide accurate conversion based on desired patient parameters and also ensure patient safety.

[0047] refer to Figure 1C, fluid (i.e., air) enters fluid expansion region 18 (also referred to as power bubble 18) through inlet 12. The fluid narrows and passes through nozzle 20, which leads to diverging flow path 22 (e.g., bifurcates). Bubble 18 acts as a flow stabilizer and disrupts any boundary layer that has been established. In various embodiments, nozzle 20 has a substantially uniform cross-sectional area and terminates at transition surface 24. In some embodiments, nozzle width 46 is between about 10% and 30% of the maximum diameter of bubble 18. Nozzle 20 has a nozzle width 46 and a nozzle length 48 that affect the performance of various embodiments.

[0048] In various embodiments, the nozzle 20 terminates in a step 26 and a transition surface 24, which may be a tapered or curved surface. Alternatively, the transition surface 24 may also be a step 26 (so the two surfaces 24 and 26 after the nozzle 20 may be stepped). The step 26 has a given step offset 28, which may affect the performance of the device 10. Similarly, the transition surface 24 may have a specific radius of curvature 30 (e.g., particularly where the transition surface 24 intersects the nozzle 20). In various embodiments, the radius of curvature 30 is referred to as the "nozzle radius 30".

[0049] The splitter 32 separates the fluid passage 34 so that the fluid can travel toward the patient outlet 14 or the exhaust port 16. Various embodiments adjust the splitter distance 36 (i.e., the distance from the end of the nozzle 20 to the splitter 32) to achieve the desired performance characteristics. In various embodiments, the splitter distance 36 can be the distance from the step 26 to the proximal end 38 of the splitter 32. The proximal end 38 can define a splitter width 40.

[0050] The nozzle 20 defines a central nozzle axis 42, which in various embodiments can be identical to a central longitudinal axis 44 of the valve 10. The flow divider 32 can be offset to one side (eg, the flow divider 32 is not aligned with the nozzle axis 42). Figure 1D As shown, the proximal end 38 of the flow diverter 32 is not aligned with the longitudinal axis 42 of the nozzle 20 .

[0051] Figure 2 A valve 10 according to an exemplary embodiment of the present invention is schematically shown. The fluid valve 10 is configured to provide a number of advantages over the prior art, with reference to Figure 2 Many advantages thereof are described. It should be appreciated that some valves 10 may provide one or more of the various advantages listed herein. Various embodiments may include the following features and / or advantages:

[0052] As previously mentioned, the exemplary embodiments do not require a specific radius of curvature 30 (also referred to as a nozzle radius 30) on the transition surface 24 of the device 10. In fact, various embodiments do not require a radius of curvature 30 and may instead use a flat transition surface 24 (i.e., zero nozzle radius of curvature 30). In various embodiments, a variety of transition surfaces 24 may be used to achieve desired valve 10 performance characteristics.

[0053] Exemplary embodiments offset the diverter 32 60 from the nozzle axis 42. Prior art devices 10 known to the inventors axially align the nozzle axis 42 with the center of the diverter 32. In contrast, various embodiments offset the nozzle axis 42 60 from the diverter 32 (e.g., offset the nozzle axis 42 from the center of the diverter surface 38 or completely offset from the diverter surface 38). In addition, in various embodiments, the diverter 32 is configured such that the bifurcated pathway 34 is non-uniform. Various embodiments use the offset diverter 32 to bias the fluid flow toward the patient-side circuit 21 (e.g., fluid conduits, endotracheal tubes, and other fluid connections downstream of the valve 10), which produces certain physiologically desirable characteristics.

[0054] Figure 3 The flow of fluid through the device 10 according to an exemplary embodiment of the present invention is schematically illustrated. Because the diverter 32 (also referred to as a redirector) is not located directly in front of the nozzle 20, the fluid flows toward the lungs of the patient 62. Therefore, the location of the flow through the diverter 32 is biased toward the lungs (i.e., toward the patient 62), without requiring a specific curve on the transition surface 24. In addition, it is believed that the transition surface 24 (which is located at Figure 3 The small step 26 (also a step 26) helps bias the flow toward the patient outlet 14 (e.g., toward the lungs). The small step 26 is believed to create a small low pressure area that helps pull the fluid toward the transition surface 24.

[0055] Back to Figure 2 , various embodiments also provide asymmetric fluid flow paths 34. In addition, fluid flow paths 34 have different lengths and / or widths. Asymmetric fluid flow paths 34 with different sizes provide desired performance characteristics. For example, asymmetric branches help achieve clinically safe PIP, PEEP, RR and / or IE ratios.

[0056] In addition, the valve 10 advantageously provides in-line fluid flow, such that the fluid flow path 34 of the inlet 12 and / or outlet 14 is parallel to (e.g., identical to) the main axis 44 of the device 10. In some embodiments, the nozzle axis 42 is identical to the longitudinal axis of the device 10. The longitudinal axis of the device 10 may also pass through the inlet 12. In some embodiments, the various components are coplanar (i.e., they share a common plane). Thus, flow is not required to enter the device 10 orthogonally, and the form factor of the device 10 produces a compact, simple, streamlined device 10 without components that can catch and snag on objects.

[0057] Various embodiments include a fluid expansion region 18 that is distal to the inlet 12 of the device 10. The inventors believe that the fluid expansion region 18 helps induce turbulence, which is contrary to the expectations of the prior art and increases performance stability. Therefore, in various embodiments, the device 10 is configured to generate turbulent fluid flow and control turbulent fluid flow. This is in contrast to other prior art devices 10 that are intended to reduce turbulence.

[0058] Various embodiments are configured to receive air input between about 3 psi to about 5 psi and provide between about 0 cmH20 to about 40 cmH20 to the patient.

[0059] like Figure 1C As best shown in , various parameters of the valve 10 can be adjusted to achieve specific performance characteristics for treating a patient (e.g., a human patient). For example, the patient throttle area 50, channel depth 52, and nozzle width 46 can be adjusted to control the PIP for a desired clinical outcome.

[0060] In addition, the exhaust throttle area 58 and / or the exhaust port 16 branch angle can be adjusted to control the PEEP and IE ratio to obtain the desired clinical results. In particular, the exhaust angle of the outlet branch 54 and the exhaust angle of the inlet branch 56 can be adjusted.

[0061] Figure 4A A fluid valve 10 according to an exemplary embodiment of the present invention is schematically illustrated. Figure 4B Schematically shows the Figure 4A 1 and 2. Examples of airflow characteristics and breathing parameters achieved by the exemplary valve 10 of FIG. 1. As can be seen, the transition surface 24 can be a flat step 26. In addition, as shown, various embodiments can position the diverter so that it does not intersect the nozzle axis 42. It should be understood that the airflow characteristics shown are examples and are not intended to limit the various embodiments of the present invention.

[0062] Figure 5A A fluid valve 10 according to an exemplary embodiment of the present invention is schematically illustrated. Figure 5B Schematically shows the Figure 5A Examples of airflow characteristics and breathing parameters achieved by the exemplary valve 10 of FIG. As shown, various embodiments may have multiple exhaust ports 16. It should be understood that the airflow characteristics shown are examples and are not intended to limit the various embodiments of the present invention.

[0063] Figure 6 Various performance parameters achieved by exemplary embodiments are schematically shown. It should be understood that the performance parameters shown are examples and are not intended to limit the various embodiments of the present invention.

[0064] FIG. 7A to FIG. 9 The various embodiments of the valve 10 are used to discuss the effects on the respiratory setting. These terms are understood by those skilled in the art. However, FIG. 7A to FIG. 9 to describe the inventors' beliefs about how valve 10 affects these breathing settings. In addition, FIG. 7A to FIG. 9 Exemplary values ​​may be shown, such as 20 LPM, which are not intended to limit the various embodiments but are instead shown for purposes of example.

[0065] 7A to 7C The effect of the valve 10 on PIP according to an exemplary embodiment of the present invention is schematically illustrated. In general, PIP (peak inspiratory pressure) is well defined and is related to the cross-sectional area of ​​the nozzle 20 (nozzle width 46 x passage depth) and the motive flow rate. In this example, 7A to 7C The flow rate into the inlet 12 is shown (eg, 20 LPM). It should be understood that the reference to 20 LPM is for discussion purposes only and is not intended to limit the various embodiments. Various embodiments produce air jet velocities of approximately 100 m / s (depending on the device 10).

[0066] like Fig. 7A As shown, the jet remains against the transition surface 24 until the patient back pressure rises to a point where the flow in the cross section of the patient throttle valve 50 (shown in green) stagnates to zero (as shown in FIG. Figure 7B Then, the fluid flows to the exhaust port 16 (as shown in FIG. Figure 7C The stagnation pressure created in the cross-sectional area of ​​the patient throttle valve 50 at the point of flow switching is referred to as PIP.

[0067] PIP can be measured using patient monitoring device data from a patient airway pressure gauge or from a test device that records this data along with air flow. Figure 7C In the , the return flow varies throughout the exhaust phase and does not have a defined tumble flow rate back into the inspiration cycle. Instead, the flow rate is a function of the pressure indicated by the circular blue arrow 51 which holds the jet in place.

[0068] FIG. 8A to FIG. 8BThe effect of valve 10 on PEEP according to an exemplary embodiment of the present invention is schematically illustrated. In general, PEEP (Positive End Expiratory Pressure) is more complex to regulate and relies on more geometric aspects. As fluid flows to the exhaust 16 port, a low pressure recirculating 'bubble 18' (blue 51) maintains the jet until enough energy has dissipated and the 'bubble 18' or vacuum lock can be broken by turbulent air of the return flow 53 (purple). The fluid then flows back toward the outlet 14 and toward the patient and repeats for another breathing cycle. 7A to 7C The process shown.

[0069] exist Figure 8B In the embodiment shown, the area of ​​the gas bubble 18 and its collapse can be directly controlled using a variable set screw. This allows PEEP to be controlled to a wide range of values.

[0070] In various embodiments, PEEP is affected by:

[0071] Angle of deflection of the main jet,

[0072] The cross-sectional area of ​​the exhaust throttle valve 58,

[0073] 'Bubble 18' area geometry,

[0074] ·Angle of exhaust port 16 branch (non Figure 8B With a bifurcated exhaust port 16 and without a nozzle exit step 26).

[0075] Fig. 9 The effect of the valve 10 on the IE ratio setting according to an exemplary embodiment of the present invention is schematically illustrated. The IE (inspiration-expiration) ratio is the ratio of the duration of inspiration to the duration of expiration. For example, an IE of 1:2 means that the expiration portion during a single breath is twice as long as the inspiration portion. The inspiration portion of the breathing time is essentially defined by the physiological requirements set by the physician during the design of the device 10.

[0076] Various implementations can be adjusted to adjust the following parameters:

[0077] RR (respiratory rate),

[0078] TV (tidal volume),

[0079] MV (minute ventilation) = RR x TV,

[0080] Inspiratory time.

[0081] The orange arrow indicating the cross-sectional area of ​​the exhaust throttle 58 partially regulates the exhalation rate. The more complex this path is, the greater the resistance, and therefore the greater the IE ratio (slower exhalation). This size also controls the PEEP value to some extent, so the size in this area needs to be adjusted together.

[0082] Fig.10 The airway flow and airway pressure waveforms when the valve 10 is in use according to an exemplary embodiment of the present invention are schematically shown. Starting from the BLUE point (point A), the inhalation phase begins. The complete motive flow (i.e., the flow rate of the inlet 12 of the clean gas (air / oxygen) provided to the device 10) is preferentially attracted to the transition wall and flows toward the patient outlet 14. In some embodiments, the attraction to the patient's side wall can be caused by the "Coanda effect", in which the low pressure generated by the high nozzle 20 speed causes the fluid jet to tend to be directed toward the patient wall. However, various embodiments can be configured to operate without the use of the Coanda effect. Ambient air is entrained through the exhaust port 16 port during inspiration. Peak entrainment occurs at the moment the inhalation phase begins. As the inhalation phase progresses, the entrainment gradually decreases until the point of switching to exhalation, at which the entrainment value is approximately zero.

[0083] When the jet flips from the patient outlet 14 to the exhaust port 16, the patient exhalation begins. The inventors believe that the switching point occurs when the patient airway flow rate equals the motive flow rate. This switching point can be viewed as an internal energy balance. For example, when the potential energy + kinetic energy in the incoming flow equals the potential energy + kinetic energy stored in the patient's airway, then the device 10 switches to the exhalation phase.

[0084] Described another way, the device 10 operates in a flow regime that can be considered incompressible, and therefore, the air entering the device 10 is equal to the air removed from the device 10. Therefore, if the patient air flow rate slows to the same as the motive flow rate, the air switches to the exhalation phase. Thus, in various embodiments, the inventors suspect, but have not confirmed, that the main jet is deflected toward the patient outlet 14 due to the "Coanda" effect, but the switching time (e.g., Fig.10 The switching point B) in is defined by the internal energy balance. This energy balance is calculated by the Bernoulli equation and is defined at the cross-sectional area of ​​the “patient throttle valve 50”.

[0085] Continuing from the GREEN point (point B): after the jet is deflected toward the exhaust vent 16 port, the patient airway air flow is reversed and exhausted from the exhaust vent 16 (along with the motive flow).

[0086] The peak exhaust port 16 flow rate is a function of:

[0087] The internal resistance of the valve 10 is defined by its geometry,

[0088] The patient's airway resistance, and

[0089] The patient's airway pressure,

[0090] As the exhaust 16 phase progresses, the patient airway pressure decreases, which causes the total exhaust 16 flow rate to decrease.

[0091] As previously mentioned, the exhaust 16 branch side is different from the patient side. This part of the cycle appears to rely on low pressure recirculating 'bubbles 18' (such as Fig.10 The low pressure recirculation 'bubble 18' is formed by the jet velocity and the geometry of the valve 10 in this area (shown by the red arrow 61 in FIG. 1 ). The stronger this 'bubble 18' is, the lower the PEEP pressure is.

[0092] As patient airway flow decreases, less and less of the "bubble 18" is pushed upward into the recirculation region until the point where the bubble 18 "pops" and the jet is free to return to the patient outlet 14 to begin the inhalation cycle again.

[0093] The various embodiments described herein are advantageously configured to automatically switch a patient from inspiration to exhalation, and vice versa. Thus, when coupled to a patient (e.g., a patient whose breathing is completely controlled externally by a ventilator), the device 10 can be referred to as oscillating between fluid flow paths leading to the outlet 14 and the exhaust port 16. This is in contrast to some other embodiments that can be operated as a switch having two or more stable states (e.g., bistable). This bistable switching device 10 requires an external trigger (e.g., external pressure applied by a patient beginning to inhale or exhale) to switch states (i.e., switch flow paths). In various embodiments, the device 10 is configured so that the fluid flow automatically returns to the patient outlet 14 after it is transferred to the exhaust port 16. Thus, the device 10 can be described as a fluid oscillator.

[0094] FIG. 11A to FIG. 11C The apparatus 10 according to an exemplary embodiment of the present invention is schematically shown. The apparatus 10 is configured to reduce the concentration of an input fluid source 66 (e.g., oxygen or other gas). Although reference is made to FIG. 11A to FIG. 11C Description is made, but it should be understood that all of the various embodiments previously described may be coupled to a fluid source 66. The device 10 has a distal end 6 closer to the patient circuit 21 and a proximal end 8 closer to the fluid source 66 and / or inlet 12.

[0095] like FIG. 11A to FIG. 11CAs shown, some embodiments may not include the fluid expansion zone 18. Alternatively or in addition, various embodiments may include a dilution nozzle 80. In various embodiments, the fluid from the fluid source 66 (e.g., 95% medical grade oxygen) passes through the dilution nozzle 80 and is diluted with ambient air (approximately 21% oxygen). In some embodiments, the dilution nozzle 80 may also be referred to as the inlet nozzle 80. Thus, the fluid passing through the dilution nozzle 80 (e.g., in a direction from the proximal end 8 toward the distal end 6) can be diluted with air received through the port 64.

[0096] Thus, one or more ports 64 may be adjacent to the dilution nozzle 20. Otherwise, FIG. 11A to FIG. 11C The device 10 may include some or all of the features of the various embodiments described herein. Port 64 may be referred to as "outlet-side port 64" or "exhaust-side port 64" to indicate the relative position relative to the cross-sectional view (e.g., outlet-side port 64B is closer to outlet 14 than exhaust-side port 64A). In a similar manner, the device may have an outlet-side surface 74 and an exhaust-side surface 76. In some embodiments, port 64 may be positioned distally relative to dilution nozzle 80 (e.g., as shown in FIGS. 11 to 13 ). Fig.14 However, in some other embodiments, the port 64 may be positioned proximally relative to the dilution nozzle 80 .

[0097] One or more ports 64 can provide a number of advantages. For example, the port 64 can operate a safety mechanism that limits the pressure on the patient 62 side. In particular, the device 10 can limit the input gas (e.g., oxygen) flow rate through the device nozzle 20. As the fluid flow rate through the inlet 12 increases beyond a given threshold, the path of least fluid resistance becomes the one or more ports 64. Thus, the fluid flow is directed out of the port 64, which can be adjusted to provide an upper limit on the fluid flow rate through the device nozzle 20.

[0098] In contrast, one or more exhaust ports 16 of the device 10 can be downstream of the device nozzle 20 and assist in automatic switching between fluid flow paths as described above (e.g., between the outlet 14 or the exhaust ports 16). In various embodiments, the port 64 is upstream of the device nozzle 20. The port 64 can help control and limit the total amount of fluid flow through the device nozzle 20.

[0099] Another advantage of various embodiments includes a reduction in the amount of source fluid (e.g., oxygen source) used. In various embodiments, the fluid source 66 (e.g., provided by medical personnel) can have a given FiO2 percentage (e.g., emergency personnel carry them with them, such as 95% medical grade oxygen FiO2). The fluid source 66 used by medical personnel tends to be a higher concentration of oxygen (e.g., 95% FiO2). Depending on the desired patient-side parameters output by the device 10, the preferred or acceptable range of FiO2 can vary. Various embodiments use one or more ports 64 (also referred to as dilution ports 64 or suction ports) to dilute the fluid from the fluid source 66 with air from the environment (i.e., ambient air with an oxygen concentration of approximately 21%). Therefore, the dilution port 64 is configured so that air from the external environment is brought into the device 10 to dilute the input fluid (e.g., the fluid through the inlet 12). The diluted fluid flows to the patient through the device nozzle 20.

[0100] Typically, the fluid source 66 and associated equipment (e.g., regulator 68, fluid conduits, etc.) are configured to provide a given flow rate of fluid into the device 10. For purposes of discussion, the fluid source 66 may be 100% oxygen. However, it should be understood that any concentration of oxygen may be used, and indeed, some embodiments may use a fluid source 66 that does not contain oxygen.

[0101] In the absence of a port, the flow rate from the fluid source 66 remains constant when the fluid flow is switched from the patient outlet 14 to the exhaust port 16. Therefore, the input fluid flow rate from the source remains constant even when the fluid is flowing to the exhaust port 16. In various embodiments, the fluid flow is constant because the fluid flow acts as a control flow that switches the flow path from the outlet 14 to the exhaust port 16 and vice versa. Therefore, in various embodiments, when the patient 62 exhales, the fluid from the source 66 is wasted. Therefore, the exemplary embodiment uses ambient air to reduce the higher concentration of the fluid source 66 and provide mixed / diluted air to the patient 62. In some embodiments, the port 64 can greatly dilute the fluid from the fluid source 66 (e.g., diluting the fluid from the fluid source 66 by 15%-60%).

[0102] Various embodiments may use, for example, an oxygen D bottle (i.e., 340 liters) as a source. Depending on the amount of time that the patient 62 is fluidly connected to the fluid source 66, there is a problem that the oxygen source may be exhausted (e.g., after 15 to 20 minutes). The dilution port 64 is configured so that the mainstream from the inlet 12 is involved in the fluid flow from the external environment. For example, the flow rate through the device 10 can be configured to be approximately 20 liters per minute. In the absence of a dilution port, 20 liters per minute are obtained from the source. However, an exemplary embodiment with a dilution portion can reduce the flow rate from the source (e.g., to 12 LPM) and involve ambient air through the dilution portion (e.g., to obtain the remaining 8 liters per minute, thereby providing a total flow rate of 20 lpm). Therefore, the exemplary embodiment reduces the fluid flow rate from the fluid source 66 and extends the service life of the fluid source 66. This is particularly advantageous in emergency situations (e.g., when a smaller fluid source is available).

[0103] FIG. 12A to FIG. 12C Various configurations of biasing air flow through the inlet 12 according to exemplary embodiments of the present invention are schematically illustrated. Fig. 12A Air flow is schematically shown through the inlet 12 and substantially aligned with the device nozzle axis 42. Air flow may also be entrained 70 from outside the device 10 through the dilution port 64. The entrained air flow 70 joins the main fluid flow entering through the inlet 12 as shown. Fig. 12B and Fig. 12C The entrained flow 70 is not shown, but it should be understood that these embodiments also entrain air flow 70 from the environment or from another source (unless the port 64 is blocked).

[0104] Without wishing to be bound by any theory, the inventors believe, but have not confirmed, that the suction effect through port 64 is caused by the relatively low pressure at outlet 14 of dilution nozzle 20 relative to the air outside device 10. This low pressure is created by the high velocity exiting dilution nozzle 20. The relatively high pressure outside device 10 causes ambient air to enter a relatively low pressure region in device 10 where it joins the fluid jet from inlet 12 (e.g., from fluid source 66).

[0105] In various embodiments, Fig. 12A represents a fluid flow substantially parallel to the device nozzle axis 42. The fluid flow profile 72 is Fig. 12A Reference FIG. 12A to FIG. 12C As shown, the profile 72 can affect the bias of the fluid flow in various ways. The inventors have discovered that the profile 72 of the fluid flow also affects the PIP and / or PEEP of the device 10, as well as other end patient parameters (eg, IE ratio, etc.).

[0106] Fig. 12BThe schematic diagram shows the air flow entering through the inlet 12 and advancing toward the exhaust side wall 76 (at least in the view shown). This ultimately changes the position of the fluid flow relative to the nozzle 20. The profile 72 of the fluid flow is Fig. 12B Schematically shown in . The main direction 78 of the air flow entering the device 10 is shown as pointing to the exhaust port side wall 76. Exemplary embodiments can provide this air flow direction by changing the relative orientation of the inlet 12 and / or the dilution nozzle 80 (for example, by rotating the position of the inlet 12 relative to the device 10) so that the fluid flow is substantially directed to the exhaust port side wall 76. In addition or alternatively, the fluid flow direction can be changed by blocking one or more dilution ports 64. For example, some embodiments can block the exhaust port side port 64A. The inventor believes that this creates a low pressure area that biases the flow toward the exhaust port side wall 76. Some embodiments may include a movable closure 82 on one or more of the ports 64 (for example, a physician's finger can be used to slide). By closing one or more ports 64, the performance of the device 10 can be adjusted.

[0107] Fig. 12C The main direction of the air flow 78 through the inlet 12 is shown schematically, which is directed towards the outlet side wall 74. This ultimately changes the position of the fluid flow relative to the nozzle 20. The profile 72 of the fluid flow is Fig. 12C Schematically shown in . The main direction of the air flow 72 entering through the nozzle 20 is shown as pointing to the patient side outlet 14. Exemplary embodiments can provide the direction of the air flow by changing the relative orientation of the inlet 12 and / or the dilution nozzle 80 (e.g., by rotating the position of the inlet 12 relative to the device 10) so that the fluid flow is substantially directed to the patient side wall 74. In addition or alternatively, the fluid flow direction can be changed by blocking one or more dilution ports 64. For example, some embodiments can block the patient side port 64B. The inventor believes that this will produce a low pressure area that biases the flow toward the patient side wall. Some embodiments may include a movable closure 82 (e.g., slidable with a finger) on one or more of the ports 64. By closing one or more ports, the performance of the device 10 can be adjusted.

[0108] By biasing fluid flow toward the patient side wall 74, the exemplary embodiment increases PIP and / or PEEP. On the other hand, by biasing fluid flow toward the exhaust side wall 76, the exemplary embodiment reduces PIP and / or PEEP. The inventors have further discovered that obstruction of the port 64 has varying degrees of impact on overall device 10 performance.

[0109] Based on the above disclosure, it should be apparent that various embodiments may adjust fluid flow dynamics by blocking the dilution port 64 and / or by adjusting the relative orientation of the dilution nozzle 80 with respect to the device nozzle 20. In various embodiments, the dilution nozzle 80 and the device nozzle 20 share a common plane (e.g., even when the inlet 12 is rotated, such that the direction of the air flow changes but the fluid flow remains substantially coplanar).

[0110] Some embodiments may adjust the inlet 12 so that it is not in line with the device nozzle axis 42 (e.g., perpendicular to the device nozzle axis 42) so that the primary direction of the incoming air flow is perpendicular to the device nozzle axis 42. The inventors believe that this configuration is not preferred because the primary direction of the air flow will not be directed toward the device nozzle 20, but instead will hit some other part (e.g., the wall of the atrium 84 of the device 10). The back pressure generated by the flow hitting the wall and then expanding outward will likely cause inconsistent performance through the port and instead cause the port 64 to operate as an exhaust port 16 instead of an intake / entrainment port 64.

[0111] In various embodiments, when:

[0112] (1) Both ports 64 are open and the device 10 operates smoothly and consistently;

[0113] (2) the patient-side port 64 is blocked, and PIP and PEEP are increased;

[0114] (3) The exhaust port 64 is blocked, and PIP and PEEP are reduced.

[0115] It should be understood that the various flow profiles 72 and fluid flow directions shown herein are for discussion purposes and are not intended to limit the various embodiments. In fact, the flow profiles 72 and fluid flow directions are shown to facilitate discussion, rather than to imply that the profiles 72 or directions are not or cannot be different from those shown.

[0116] Fig.13 An external view of a device 10 according to an exemplary embodiment of the present invention is schematically shown.

[0117] Fig.14 An alternative embodiment of the device 10 according to the illustrative embodiment is schematically shown. Fig.14 The device 10 shown can be the same as any of the devices 10 described herein, but can also be coupled with a dilution connector 86. Additionally, a dilution nozzle 80 can be coupled to the device 10 inlet 12 via a fluid conduit 88 (e.g., using an optional flow meter 90). The dilution nozzle 80 can be configured to couple with a fluid source 66 (e.g., using standard fluid conduits and connections). The flow meter 90 helps set the device 10 to achieve a desired flow rate.

[0118] With e.g. FIG. 12A to FIG. 12C In contrast to the embodiment shown in FIG. 1 , the dilution nozzle 80 is in the dilution connector 86, which is not directly connected to the device nozzle 20. Therefore, the direction of the air flow is not like FIG. 12A to FIG. 12C In some embodiments, the inlet 12 of the fluidic device 10 may include a nozzle 20 configured to adjust the air flow in the device 10, similar to the embodiment shown in FIG. 1 . FIG. 12A to FIG. 12C The dilution nozzle 80 shown and described (but not in Fig.14 ).

[0119] FIG. 15A to FIG. 15C Schematically shows an exemplary embodiment of the present invention. Fig.14 The dilution connector 86. The adjustable closure 82 (eg, a slider) on the top section can be adjusted to control the amount of fluid drawn into the tubing 88 to flow to the fluidic device 10. The device 10 shows the stages of adjustment to achieve the final desired FiO2 and flow rate.

[0120] Fig.16 A cross-sectional view of an alternative embodiment of the device 10 according to an exemplary embodiment is schematically shown. The device 10 includes a nozzle switch 94 that provides rapid adjustment between a dilution fluid (e.g., from fluid entrained through port 64) and a pure fluid (i.e., without entrained air) received from source 66. Thus, in various embodiments, the device 10 can be (e.g., rotatably) switched between a dilution nozzle 80 and a non-dilution nozzle 81. The dilution nozzle 80 is coupled to port 64. The non-dilution nozzle 81 does not include fluid entering port 64. The user can easily switch between the dilution nozzle 80 and the non-dilution nozzle 81 by manual manipulation (e.g., by rotating the nozzles 80, 81 using a rotatable switching feature 92 (e.g., a protrusion, a textured surface, etc.) so that the fluid flow path of the inlet 12 is aligned and fluidly coupled with the nozzle 80 or 81.

[0121] Thus, some embodiments may switch between nozzles 80, 81 and / or may use a removable cover 82 to assist in entraining the air. Furthermore, while only two nozzles 80, 81 are shown, it should be understood that the device may rotate through a plurality of different nozzles 80, 81 having nozzles 80 and ports 64 of various different sizes.

[0122] In some embodiments, the fluid flow path of the inlet 12 may be non-linear, as shown. Additionally, in some embodiments, the axis 42 of the device nozzle 20 may not be parallel to the device axis 44. However, various embodiments include a planar flow path from the inlet 12 to the device nozzle 20.

[0123] Fig.17 Schematically shows a cross-sectional view of an alternative embodiment of the device 10 according to the exemplary embodiment. In particular, Fig.17 The device is shown with a planar flow path from the inlet 12 to the device nozzle 20. The device 10 includes a switching feature 92 that can be pushed to switch between the dilution nozzle 80 and the non-dilution nozzle 81. Thus, the dilution nozzle 80 or the non-dilution nozzle 81 can slide in line (e.g., parallel) with the fluid flow path from the inlet 12.

[0124] 18A to 18C The details of the nozzle switch 94 according to an exemplary embodiment are schematically shown. In various embodiments, the nozzle switch 94 is integrated into the device 10 (e.g., as shown in FIG. Fig.16 and Fig.17 However, the nozzle switch 94 may be a separate piece coupled to the device 10. Fig.18A A cross-sectional view of a nozzle switcher 94 according to an exemplary embodiment is schematically shown. Fig.18B Shows Fig.18A A partially transparent view of the nozzle switch 94. Fig.18B In the view of Fig.18A Rotate 90 degrees. Fig. 18C Schematically shows Fig.18B 1. A cross-sectional view of a nozzle switch 94 of FIG. The switch 94 may have a rotation axis 96 that is offset from the longitudinal axis 44 of the device 10. The rotating portion 98 is configured to rotate about the rotation axis 96. Although not visible from this view, the switch 94 allows rotation through the various dilution nozzles 80 and non-dilution nozzles 81 while keeping the flow paths of the device 10 coplanar and substantially colinear.

[0125] FIG. 18B to FIG. 18CThe arrangement of the switch 94 in the entrained flow configuration is schematically shown, wherein the switch 94 is in a first configuration (also referred to as a dilution configuration). In the dilution configuration, the vent channel 80A having an opening 102 leading to the port 64 is aligned with the fluid flow path of the device 10. The switch 94 can be converted to a non-dilution configuration (not shown), wherein the non-vent channel 81A having a blocking element 104 for the port 64 is aligned with the fluid flow path of the device 10. In particular, the rotating portion 98 is configured so that the user's transition to the graspable feature 92 causes the rotation of the rotating portion 98, which aligns the vent channel 80A or the non-vent channel 81A with the fluid flow path of the device 10. In order to switch from a pure flow from the fluid source 66 to a dilution flow, the user can simply rotate the switch 94. It should be understood that although the switch 94 shows 50% printed thereon, the various embodiments are not limited to a dilution of 50%. In fact, the various embodiments can achieve any desired percentage (e.g., 55%) of dilution oxygen concentration.

[0126] In various embodiments, the switch 94 includes an alignment feature 100 (e.g., a wall 100A and a protrusion 100B) configured to align the channels 80A and / or 81A with the fluid flow path of the device 10. In addition, the alignment feature 100 prevents over-rotation of the rotating portion 98. Thus, a user can easily and reliably switch the switch 94 between a first configuration (e.g., in which the device nozzle 20 is fluidly coupled to the port 64) and a second configuration (e.g., in which the device nozzle 20 is fluidly separated from the port 64). In addition, due to the alignment feature 100 (e.g., the user rotates the rotating portion 98 until it no longer rotates), the switching can occur without the channels 80A and / or 80B being aligned with the fluid flow path of the device 10. The device 10 can also be locked in the first configuration and / or the second configuration so that a threshold force must be applied to switch the switch 94 (e.g., it is not easily disengaged from the set configuration).

[0127] In various embodiments, the rotation axis 96 is advantageously offset from 91 so that the channels 80A and 81A are aligned with the central axis 44 of the device 10 when rotated. Thus, the device 10 can maintain a substantially planar fluid flow path. In addition, the exemplary embodiment can use a small angle rotation (e.g., 45 degrees or less) to convert between the first configuration and the second configuration. Of course, various embodiments may require different angular rotations to convert between configurations (e.g., greater than 45 degrees).

[0128] Fig.19 The process of mechanical ventilation using the device 10 according to an exemplary embodiment of the present invention is shown. It should be noted that this method is substantially simplified from the longer process that can usually be used. Therefore, Fig.19The method shown may have many other steps that those skilled in the art may use. In addition, some steps may be performed in an order different from the shown order, or may be performed simultaneously. In addition, in some embodiments, some of these steps may be optional. Therefore, process 1900 is only an example of a process according to an illustrative embodiment of the present invention. Therefore, those skilled in the art may appropriately modify the process.

[0129] Process 1900 begins at step 1902, which provides a fluidic device 10 as described herein. Briefly, the device 10 includes an inlet 12 configured to receive fluid from a pressurized source 66 (e.g., a mechanical ventilator or a pressurized tank). The device 10 also includes an outlet 14 configured to couple with a breathing circuit 21 of a patient 62 and an exhaust port 16.

[0130] At step 1904, the inlet 12 of the device 10 is coupled to the fluid source 66 and / or the mechanical ventilator. At step 1906, the outlet 14 is coupled to the breathing circuit 21 of the patient 62. Steps 1904 and 1906 may be performed in different ways. Fig.19 The order shown occurs.

[0131] At step 1908, ventilation flow is provided by the device 10 to achieve the desired patient ventilation parameters. Advantageously, various embodiments are configured to automatically convert the patient 62 from inspiration to exhalation and vice versa. Therefore, when connected to the patient 62 (e.g., when breathing is completely controlled by the outside of the ventilator), the device 10 can be considered to oscillate between the fluid flow path 34 leading to the outlet 14 and the exhaust port 16. In addition or alternatively, some embodiments can be operated as a switch with two or more stable states (e.g., bistable). This bistable switching device 10 requires an external trigger (e.g., external pressure applied by a patient starting to inhale or exhale) to switch states (i.e., switch flow paths). In various embodiments, the device 10 is configured so that the fluid flow automatically returns to the patient outlet 14 after it is transferred to the exhaust port 16. Therefore, the device 10 can be described as a fluid oscillator. The device 10 can be operated in a given mode based on the mode of the ventilator (e.g., controlled ventilation, assisted ventilation, supported ventilation).

[0132] In various embodiments, device 10 may be configured to produce desired patient ventilation parameters. Fig.10Schematically shows the patient parameters modulated by various devices 10. For example, the device 10 can be configured to generate a target PIP between about 18cmH20 and 30cmH20 in the patient circuit 21. Then, after reaching the target PIP, air flows out of the exhaust port until a PEEP between about 6cmH20 and 14cmH20 is achieved in the patient circuit 21. The steps of making the air flow out of the outlet 14 and the steps of making the air flow out of the exhaust port 16 define the respiratory rate of the patient 62 between about 10 breaths per minute and about 30 breaths per minute. Some embodiments can define a respiratory rate between about 16 breaths per minute and about 30 breaths per minute. The tidal volume delivered to the patient 62 from the device 10 can be between about 200ml and about 500ml, or between about 220ml and about 465ml. In some embodiments, the device 10 is configured to provide an IE ratio between about 1.5 and 2.0. The device 10 can receive an air input at a pressure between about 3psi and about 5psi. Various embodiments may be used to control ventilation or support ventilation of a patient.

[0133] The process then proceeds to step 1910, which dilutes the ventilation flow from source 66. In some embodiments, for example, when port 64 is integrated into device 10 and opened, the ventilation flow can be automatically diluted. Thus, in some embodiments, step 1910 and step 1908 occur simultaneously. However, in some other embodiments, dilution of the air flow can be achieved by opening port 64 (e.g., by using Fig. 12B 82, which can be slidable with the physician's fingers), and coupling the dilution connector 86 to the device 10 (e.g., as FIG. 15A to FIG. 15C ) and / or by using a nozzle switch 94 (e.g., Figures 16 to 18C In various embodiments, the device 10 includes at least one port 65 having an opening to an environment external to the device 10, wherein the device is configured such that an ambient fluid enters the device through the port and mixes with the source fluid.

[0134] At step 1912, the process asks whether to remove the patient from ventilation? If the patient is not ready to be removed from ventilation, the process can return to step 1908, which continues to provide ventilation flow. However, if the physician decides to change the ventilation flow parameters, the process can optionally return to step 1902, which provides a different version of the device 10 configured to provide different ventilation parameters. The processes 1902-1912 can then be repeated. If the patient is ready to be removed from ventilation, the process proceeds to step 1912 and the fluid device 10 is disconnected from the patient circuit 21. The process then ends.

[0135] Obviously, the device 10 can be operated according to various parameters. In addition, advantageously, various embodiments operate passively, that is, the device 10 switches between directing the air flow to the patient 62 and the exhaust port 16 without the need for a mechanical or electrical switch. However, some embodiments may include a controller and / or electronics configured as an auxiliary switch.

[0136] As used in this specification and claims, the singular forms "a," "an," and "the" refer to plural referents unless the context clearly dictates otherwise. For example, reference to "a port" in the singular includes a plurality of ports, and reference to "an exhaust port" in the singular includes one or more exhaust ports and equivalents known to those skilled in the art. Thus, in various embodiments, any reference to the singular includes the plural, and any reference to more than one component may include the singular.

[0137] Although various inventive embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily appreciate various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each of these variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein and shown in the accompanying drawings are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications in which the teachings of the present invention are used. Those skilled in the art will recognize or be able to determine many equivalents to the specific inventive embodiments described herein using only routine experimentation.

[0138] Therefore, it should be understood that the foregoing embodiments are presented by way of example only, and within the scope of the appended claims and their equivalents, embodiments of the present invention may be practiced in a manner different from that specifically described and claimed. The exemplary embodiments of the present disclosure relate to individual features, systems, articles, materials, kits and / or methods described herein. In addition, if two or more such features, systems, articles, materials, kits and / or methods are not inconsistent with each other, any combination of these features, systems, articles, materials, kits and / or methods is included in the scope of the invention disclosed herein. The disclosed embodiments or parts thereof may be combined in a manner not listed above and / or not explicitly claimed. Therefore, one or more features from various disclosed examples and embodiments may be combined in various ways. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

[0139] Various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in an order different from that illustrated, which may include performing some actions simultaneously, even though illustrated as sequential actions in an illustrative embodiment.

[0140] Although the above discussion discloses various exemplary embodiments of the present invention, it should be apparent that those skilled in the art can make various modifications that will achieve some of the advantages of the present invention without departing from the true scope of the invention.

Claims

1. A fluid device, comprising: an inlet configured to receive a fluid from a pressurized source; a device nozzle having a device nozzle axis, a device nozzle length, and a device nozzle width; as well as at least one port having an opening to an environment external to the device, wherein the device is configured such that an ambient fluid enters the device through the port and mixes with a source fluid from the inlet to define a diluted fluid mixture, the device being configured such that the diluted fluid mixture enters the device nozzle.

2. The fluid device according to claim 1, wherein: The inlet has a dilution nozzle defining a dilution nozzle axis.

3. The fluid device according to claim 2, wherein: The device nozzle axis and the dilution nozzle axis are substantially parallel.

4. The fluidic device of any preceding claim, further comprising a plurality of ports.

5. A fluidic device according to any preceding claim, further comprising a closure for each port.

6. A fluidic device according to any one of the preceding claims, wherein: The closure element can be opened or closed in an adjustable manner.

7. A fluidic device according to any one of the preceding claims, wherein: The device is configured such that closing the port biases fluid flow through the device.

8. A fluidic device according to any one of the preceding claims, wherein: Fluid exiting the inlet is biased toward an outlet side of the nozzle.

9. A fluidic device according to any one of the preceding claims, wherein: Fluid exiting the inlet is biased toward the exhaust side of the nozzle.

10. A fluidic device according to any one of the preceding claims, wherein: PIP and PEEP can be selectively adjusted by closing and / or opening the one or more ports.

11. A fluidic device according to any one of the preceding claims, wherein: A desired flow rate through the nozzle is achieved that is higher than the flow rate out of the inlet.

12. A fluidic device according to any one of the preceding claims, wherein: The port acts as a safety vent.

13. A fluidic device according to any one of the preceding claims, wherein: The inlet and the device nozzle are integrally formed.

14. A fluidic device according to any one of the preceding claims, wherein: The inlet and the device nozzle are formed separately.

15. The fluid device according to claim 14, wherein: The inlet and the device nozzle are connected by a fluid conduit.

16. A fluidic device according to any one of the preceding claims, wherein: A nozzle port is integral with the inlet.

17. A fluidic device according to any one of the preceding claims, wherein: The dilution nozzle narrows in diameter from the proximal end to the distal end.

18. A system according to any one of the preceding claims, wherein: The dilution nozzle is part of the dilution connector.

19. The fluidic device according to any one of the preceding claims, further comprising: a transition surface that is part of a patient fluid path leading to an outlet coupled to a patient; a stepped surface that is part of a second fluid path leading to the exhaust port; a flow splitter that separates the first fluid path from the second fluid path, the flow splitter being asymmetric with respect to the nozzle axis, Wherein the inlet, the nozzle and the outlet share a coplanar fluid path.

20. A fluidic device according to any preceding claim, further comprising a fluid expansion zone distal to the inlet.

21. A method of mechanical ventilation, comprising the following steps: A fluid valve is coupled between the patient's breathing circuit and a pressurization source, the fluid valve having: an inlet configured to receive a fluid from a pressurized source, a device nozzle having a device nozzle axis, a device nozzle length, and a device nozzle width; as well as at least one port having an opening to an environment external to the device, wherein the device is configured such that an ambient fluid enters the device through the port and mixes with a source fluid from the inlet to define a diluted fluid mixture, the device being configured such that the diluted fluid mixture enters the device nozzle, a transition surface that is part of a patient fluid path leading to an outlet port coupled to a patient, a stepped surface that is part of a second fluid path leading to the exhaust port, a flow splitter that separates the first fluid path from the second fluid path, the flow splitter being asymmetric with respect to the nozzle axis, wherein the inlet, the nozzle, and the outlet share a coplanar fluid path; providing an air flow to the inlet of the valve; Allowing air flowing out of the outlet to flow toward the patient, achieving a target PIP of between about 18 cmH20 and 30 cmH20 for air flow out of the valve in a patient circuit; After the target PIP is achieved, air is caused to flow from the exhaust port until a PEEP of between about 6 cmH20 and 14 cmH20 is achieved in the patient circuit, wherein the steps of causing air to flow from the outlet port and causing air to flow from the exhaust port define a respiratory rate of between about 10 breaths per minute and about 30 breaths per minute.

22. According to any one of the preceding claims, wherein: The fluid expansion zone makes the flow turbulent.

23. According to any one of the preceding claims, wherein: The tidal volume delivered to the patient from the device is between about 200 ml and 500 ml.

24. According to any one of the preceding claims, wherein The device includes a plurality of exhaust ports.

25. According to any one of the preceding claims, wherein The transition surface leading to the outlet has a radius of curvature.

26. According to any one of the preceding claims, wherein The transition surface is stepped.

27. According to any one of the preceding claims, wherein: The transition surface is flat.

28. According to any one of the preceding claims, wherein The device is configured such that the separator biases fluid flow towards the outlet.

29. According to any one of the preceding claims, wherein The surface leading to the exhaust port is a step.

30. According to any one of the preceding claims, wherein: The fluid flow path leading to the exhaust port is asymmetrical to the fluid flow path leading to the outlet port.

31. According to any one of the preceding claims, wherein: The device is configured to provide an IE ratio between about 1.5 and 2.

0.

32. According to any one of the preceding claims, wherein: The device receives an air input at a pressure between about 3 psi and about 5 psi.

33. According to any one of the preceding claims, wherein: The fluid flow passage of the device has a rectangular cross-section.

34. According to any of the preceding claims, further comprising using one or more dilution ports to dilute air from the fluid source.

35. According to any of the preceding claims, further comprising exhausting air from the one or more dilution ports to the environment.

36. According to any of the preceding claims, further comprising a dilution connector having a dilution portion, the dilution connector being coupled to the device using a fluid conduit.

37. According to any one of the preceding claims, wherein: The diluted fluid flows toward a patient outlet.

38. According to any one of the preceding claims, wherein: The fluid device is configured to oscillate a fluid flow between the patient outlet and the exhaust port.

39. According to any of the preceding claims, further comprising a nozzle switch, the nozzle switch being configured to switch the device between a first configuration and a second configuration, wherein the first configuration is wherein the device nozzle is fluidly connected to the port, and wherein the second configuration is wherein the device nozzle is fluidly connected to the port.

40. The device according to claim 39, wherein The nozzle switcher transitions from the first configuration to the second configuration by rotating a transition feature, wherein the rotation is 45 degrees or less.

41. The device according to claim 40, wherein The rotation axis of the switch is offset from the central axis of the device.

42. The device according to claim 40, wherein: The first configuration includes fluidly coupling the device nozzle with a ventilation channel having an opening to the port.

43. The device according to claim 40, wherein: The second configuration includes fluidly coupling the device nozzle with a channel having a blocking element for the port.

44. A fluid valve for a mechanical ventilator, the valve comprising: an inlet configured to receive a fluid from a pressurized source; a fluid expansion region distal to the inlet, the fluid expansion region leading to a nozzle having a nozzle axis, a nozzle length, and a nozzle width; a transition surface that is part of a patient fluid path leading to an outlet coupled to a patient; a stepped surface that is part of a second fluid path leading to the exhaust port; a flow splitter that separates the first fluid path from the second fluid path, the flow splitter being asymmetric with respect to the nozzle axis, Wherein the inlet, the nozzle and the outlet share a coplanar fluid path.

45. A method of mechanical ventilation, the method comprising the following steps: A fluid valve is coupled between the patient's breathing circuit and a pressurization source, the fluid valve having: an inlet configured to receive a fluid from a pressurized source, a fluid expansion region distal to the inlet, the fluid expansion region leading to a nozzle having a nozzle axis, a nozzle length, and a nozzle width, a transition surface that is part of a patient fluid path leading to an outlet port coupled to a patient, a stepped surface that is part of a second fluid path leading to the exhaust port, a flow splitter that separates the first fluid path from the second fluid path, the flow splitter being asymmetric with respect to the nozzle axis, wherein the inlet, the nozzle, and the outlet share a coplanar fluid path; providing an air flow to the inlet of the valve; Allowing air flowing out of the outlet to flow toward the patient, achieving a target PIP of between about 18 cmH20 and 30 cmH20 for air flow out of the valve in a patient circuit; After the target PIP is achieved, air is caused to flow from the exhaust port until a PEEP of between about 6 cmH20 and 14 cmH20 is achieved in the patient circuit, wherein the steps of causing air to flow from the outlet port and causing air to flow from the exhaust port define a respiratory rate of between about 16 breaths per minute and about 26 breaths per minute.

46. ​​According to any one of the preceding claims, wherein The fluid expansion zone makes the flow turbulent.

47. According to any one of the preceding claims, wherein The tidal volume delivered to the patient from the valve is between about 220 ml and 465 ml.

48. According to any one of the preceding claims, wherein The valve includes a plurality of exhaust ports.

49. According to any one of the preceding claims, wherein The transition surface leading to the outlet has a radius of curvature.

50. According to any one of the preceding claims, wherein The transition surface is stepped.

51. According to any one of the preceding claims, wherein The transition surface is flat.

52. According to any one of the preceding claims, wherein: The device is configured such that the separator biases fluid flow towards the outlet.

53. According to any one of the preceding claims, wherein: The surface leading to the exhaust port is a step.

54. According to any one of the preceding claims, wherein The fluid flow path leading to the exhaust port is asymmetrical to the fluid flow path leading to the outlet port.

55. According to any one of the preceding claims, wherein: The device is configured to provide an IE ratio between about 1.5 and 2.

0.

56. According to any one of the preceding claims, wherein: The device receives an air input at a pressure between about 3 psi and about 5 psi.

57. According to any one of the preceding claims, wherein: The fluid flow passage of the valve has a rectangular cross-section.

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