Fluid valve

Abstract

A fluid device for a mechanical ventilator 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 ambient fluid enters the device through the port and mixes with the source fluid at the inlet to define a dilute fluid mixture. The device is further configured such that the dilute fluid mixture enters the device nozzle.

Description

[Technical field]

[0001] Priority This patent application claims priority to U.S. Provisional Patent Application No. 63 / 328,599, filed April 7, 2022, and U.S. Provisional Patent Application No. 63 / 337,997, filed May 3, 2022, the disclosures of which are incorporated by reference in their entireties herein.

[0002] Technical Field Exemplary embodiments of the present invention relate generally to fluid valves, and more particularly, exemplary embodiments relate to mechanical ventilation using fluid valves. [Background technology]

[0003] Mechanical ventilation can be a critical component of critical care services for patients and can be disastrous if mechanical ventilation is not deployed properly or safely. The challenges of responding to the recent global pandemic caused by the coronavirus COVID-19 have presented a major shortage of mechanical ventilators due to an unexpected surge in patients suffering from life-threatening respiratory failure. For example, in the United States, there was an immediate and critical need for effective, inexpensive, and simple ventilators and resuscitators. Such ventilators or resuscitators may also be needed in future local epidemic outbreaks or in resource-poor settings. Summary of the Invention [Means for solving the problem]

[0004] According to one embodiment of the invention, a fluid device for a mechanical ventilator has an inlet configured to receive 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 external to the device. The device is configured such that ambient fluid enters the device through the port and mixes with the source fluid at the inlet to define a dilute fluid mixture. The device is further configured such that the dilute fluid mixture enters the device nozzle.

[0005] In some embodiments, the fluidic device may include multiple ports. Each port may have a closure. The closure may be adjustably opened and closed. The device may be configured such that closing a port urges fluid flow through the device in a particular direction. In some embodiments, fluid exiting the inlet is urged toward the outlet side of the nozzle. In some embodiments, fluid exiting the inlet is urged toward the exhaust side of the nozzle. Additionally, PIP and PEEP are selectively adjustable by closing and / or opening one or more ports.

[0006] Among other things, the device can achieve a desired flow rate through the device nozzle that is faster than the flow rate through the inlet. The port can allow air external to the device to be drawn into the device. The drawn air can dilute the air coming through the inlet from the fluid source. The port can also function as a safety exhaust vent.

[0007] In some embodiments, the inlet and the device nozzle are formed as a unitary piece. Alternatively, the inlet and the device nozzle may be formed separately. The inlet and the device nozzle may be connected via a fluid line. The nozzle port may be integral with the inlet.

[0008] Various embodiments include a dilution nozzle having a diameter. The diameter may narrow from the proximal end to the distal end of the dilution nozzle. The dilution nozzle may be part of a dilution connector that is separate from the device. The dilution connector may also include a dilution port. The dilution connector may be coupled to the device using fluid tubing. Ambient air may be used to dilute the fluid from the fluid source using one or more dilution ports. Additionally, the air may be exhausted to the exterior of the device using one or more dilution ports. The diluted fluid may flow toward a patient outlet. In various embodiments, the fluidic device is configured to oscillate the fluid flow between the patient outlet and the exhaust port.

[0009] Among other things, the device may include a nozzle switcher configured to transition the device between a first configuration in which the device nozzle is fluidly coupled with the port and a second configuration in which the device nozzle is fluidly coupled with the port. The nozzle switcher may transition the device by rotating or sliding. The axis of rotation of the switcher may be offset from a central axis of the device. In the first configuration, the device is fluidly coupled with an air passage having an opening to the port. In the second configuration, the device is fluidly coupled to a passage having a blocking element for the port.

[0010] In various embodiments, the fluid device may include a fluid expansion zone distal to the inlet. The fluid expansion zone tapers 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 coupled to the patient. The device also has a step surface that is part of a second fluid path leading to an exhaust port. A splitter divides the first and second fluid paths. The splitter is asymmetric with respect to the nozzle axis. The inlet, nozzle, and outlet share a coplanar fluid path.

[0011] According to another embodiment, a method provides mechanical ventilation to a patient. The method couples a fluidic device between a patient's breathing circuit and a pressurized source. The fluidic device has an inlet configured to receive fluid from the pressurized source. The device also has a fluid expansion zone distal to 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 a portion of a patient fluid path leading to an outlet. The outlet is configured to couple with the patient or the patient's breathing circuit. The step surface is a portion of a second fluid path leading to an exhaust port. A splitter splits the first fluid path and the 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 airflow to an inlet of the device. The air flows from the outlet toward the patient. The airflow exiting the device creates a target PIP in the patient circuit of approximately 18 cmH2O to 30 cmH2O. Air is then flowed out of the exhaust port until a PEEP of about 6 cmH2O to 14 cmH2O is achieved in the patient circuit after the target PIP is reached. The steps of flowing air out of the outlet and flowing air out of the exhaust port define a respiratory rate of about 10 breaths per minute to about 30 breaths per minute. Some embodiments may define a respiratory rate of about 16 breaths per minute to about 30 breaths per minute. Thus, in one or more examples, the geometry of the device can at least partially effectively provide the PIP, PEEP, and respiratory rate.

[0012] In some embodiments, the fluid expansion zone is configured to make the flow turbulent. The tidal volume delivered from the device to the patient is between about 200 ml and about 500 ml, or between about 220 ml and about 465 ml.

[0013] 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.

[0014] The device may be configured such that the splitter biases the fluid flow towards the outlet. The fluid flow path leading to the exhaust may be asymmetric with the fluid flow path leading to the outlet. The device fluid flow path may have a rectangular cross-section.

[0015] In some embodiments, the device is configured to provide an IE ratio of about 1.5 to 2.0. The device may receive air input at a pressure of about 3 psi to about 5 psi. Various embodiments can be used to control ventilation or assist ventilation of a patient.

[0016] Those skilled in the art will more fully appreciate the advantages of various embodiments of the present invention from the following "Description of Exemplary Embodiments," which is described with reference to the drawings summarized immediately below. [Brief description of the drawings]

[0017] [Figure 1A] 1A and 1B show schematic views of a fluidic device according to an exemplary embodiment of the present invention; [Figure 1B] 1B shows a schematic cross-sectional view of the device of FIG. 1A rotated 90 degrees about the longitudinal axis of the device. [Figure 1C] 1C shows a schematic enlarged view of a portion of the device identified in FIG. 1B. [Figure 1D] 1C shows a schematic enlarged view of a portion of the device identified in FIG. 1B. [Figure 1E] 1A-1D with an example of a scale according to an exemplary embodiment; [Figure 1F] 2A and 2B illustrate schematic internal views of fluid flow paths of a device according to an exemplary embodiment; [Diagram 2] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Diagram 3] 2 illustrates a schematic of fluid flow through an apparatus according to an exemplary embodiment of the present invention; [Figure 4A] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Figure 4B]4B illustrates diagrammatically the airflow characteristics and exhalation parameters achieved by the exemplary device of FIG. 4A. [Figure 5A] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Figure 5B] 5B illustrates a schematic representation of airflow characteristics and exhalation parameters achieved by the exemplary device of FIG. 5A. [Figure 6] 10 illustrates diagrammatically various performance parameters achieved using an apparatus according to an exemplary embodiment; [Figure 7A] 13A-13C are schematic diagrams illustrating the effect of an apparatus on a PIP according to an exemplary embodiment of the present invention; [Figure 7B] 13A-13C are schematic diagrams illustrating the effect of an apparatus on a PIP according to an exemplary embodiment of the present invention; [Figure 7C] 13A-13C are schematic diagrams illustrating the effect of an apparatus on a PIP according to an exemplary embodiment of the present invention; [Figure 8A] 13A-13C are schematic diagrams illustrating the effect of a device on PEEP, according to an exemplary embodiment of the present invention. [Figure 8B] 13A-13C are schematic diagrams illustrating the effect of a device on PEEP, according to an exemplary embodiment of the present invention. [Figure 9] 4 illustrates a schematic diagram of the effect of an apparatus on IE ratio settings according to an exemplary embodiment of the present invention; [Figure 10] 13A-13C show schematic diagrams of airway flow and airway pressure waveforms when a device is in use, according to an exemplary embodiment of the present invention; [Figure 11A] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Figure 11B] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Figure 11C] 1 illustrates a schematic diagram of an apparatus according to an exemplary embodiment of the present invention; [Figure 12A] 11A-11C are schematic diagrams illustrating various configurations of biased airflow through an inlet of an apparatus according to exemplary embodiments of the present invention; [Figure 12B] 11A-11C are schematic diagrams illustrating various configurations of biased airflow through an inlet of an apparatus according to exemplary embodiments of the present invention; [Figure 12C] 11A-11C are schematic diagrams illustrating various configurations of biased airflow through an inlet of an apparatus according to exemplary embodiments of the present invention; [Figure 13] 1 shows a schematic external view of an apparatus according to an exemplary embodiment of the present invention; [Figure 14] 13A-13C illustrate schematic diagrams of alternative embodiments of an apparatus according to exemplary embodiments; [Figure 15A] 15 illustrates a schematic diagram of the dilution connector of FIG. 14 according to an exemplary embodiment. [Figure 15B] 15 illustrates a schematic diagram of the dilution connector of FIG. 14 according to an exemplary embodiment. [Figure 15C] 15 illustrates a schematic diagram of the dilution connector of FIG. 14 according to an exemplary embodiment. [Figure 16] 1A-1C are schematic cross-sectional views of alternative embodiments of an apparatus according to exemplary embodiments; [Figure 17] 1A-1C are schematic cross-sectional views of alternative embodiments of an apparatus according to exemplary embodiments; [Figure 18A] 1 illustrates a schematic diagram of details of a nozzle switcher according to an exemplary embodiment; [Figure 18B] 1 illustrates a schematic diagram of details of a nozzle switcher according to an exemplary embodiment; [Figure 18C] 1 illustrates a schematic diagram of details of a nozzle switcher according to an exemplary embodiment; [Figure 19] 1 illustrates a process of mechanical ventilation using an apparatus according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] In an exemplary embodiment, the fluidic device (also referred to as a fluidic valve) is configured to provide safe and accurate ventilation to the patient. The fluidic valve may be disposed between the patient's breathing circuit and a source of pressurized gas and / or a mechanical ventilation device. In some embodiments, the fluidic valve may be incorporated into a ventilator, resuscitator, bag-valve-mask, or the like. Additionally or alternatively, the fluidic valve interfaces between the patient's breathing circuit and a mechanical ventilation device (e.g., ventilator, bag-valve-mask). The fluidic valve is configured to provide safe and accurate lung-protective ventilation performance characteristics to the 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 transitions the patient from inspiration to expiration (also referred to as oscillation). Additionally, the valve includes a dilution port configured to dilute the source of fluid passing through the device toward the patient outlet. Details of the exemplary embodiments are described below.

[0019] 1A-1D are schematic illustrations of a fluid valve 10 according to an exemplary embodiment of the present invention. FIG. 1A (top right) is a schematic illustration of an exterior view of a fluid valve 10 according to an exemplary embodiment of the present invention. FIG. 1B is a schematic illustration of a cross-sectional view of the valve 10 of FIG. 1A rotated 90 degrees about the longitudinal axis of the valve 10. FIG. 1C is a schematic illustration of an enlarged view of a portion L of the valve 10 identified in FIG. 1B. FIG. 1D is a schematic illustration of an enlarged view of a portion M identified in FIG. 1B.

[0020] 1A and 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 transitions the flow of fluid (e.g., air) from the outlet 14 to the exhaust port 16, and vice versa. As described in more detail below, various embodiments are configured to provide accurate transitions based on desired patient parameters and also ensure patient safety.

[0021] Referring to FIG. 1C, a fluid (i.e., air) enters a fluid expansion zone 18 (also referred to as a power bubble 18) through an inlet 12. The fluid passes through a nozzle 20 that narrows and leads to a splitting path 22 (e.g., bifurcation). The bubble 18 acts as a flow stabilizer, breaking up the boundary layer that has already been established. In various embodiments, the nozzle 20 has a substantially uniform cross-sectional area and terminates at a transition surface 24. In some embodiments, the nozzle width 46 is about 10%-30% of the maximum diameter of the bubble 18. The nozzle 20 has a nozzle width 46 and a nozzle length 48 that affect the performance of various embodiments.

[0022] In various embodiments, the nozzle 20 terminates in a step 26 and a transition surface 24, which may be tapered or curved. Alternatively, the transition surface 24 may also be a step 26 (hence both surfaces 24 and 26 after the nozzle 20 is stepped). The step 26 has a given step offset 28 that may affect the performance of the device 10. Similarly, the transition surface 24 may have a particular radius of curvature 30 (e.g., especially where the transition surface 24 meets the nozzle 20). The radius of curvature 30 is referred to as the "nozzle radius 30" in various embodiments.

[0023] The splitter 32 divides the fluid path 34 so that 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 desired performance characteristics. In various embodiments, the splitter distance 36 may be the distance from the step 26 to a proximal end 38 of the splitter 32. The proximal end 38 may define a splitter width 40.

[0024] The nozzle 20 defines a central nozzle axis 42, which in various embodiments may be the same as a central longitudinal axis 44 of the valve 10. The splitter 32 may be biased to one side (e.g., the splitter 32 is not aligned with the nozzle axis 42). As shown in FIG. 1D, the proximal end 38 of the splitter 32 is offset from the longitudinal axis 42 of the nozzle 20.

[0025] 2 illustrates a schematic of a valve 10 in accordance with an exemplary embodiment of the present invention. The fluid valve 10 is configured to provide several advantages over the prior art, many of which are described with reference to FIG. 2. It should be understood that some valves 10 may provide one or more of the various advantages enumerated herein. Various embodiments may include the following features and / or advantages.

[0026] As previously mentioned, the exemplary embodiments do not require a particular radius of curvature 30 (also referred to as nozzle radius 30) on the transition surface 24 of the apparatus 10. In fact, various embodiments may not require a radius of curvature 30 and instead use a flat transition surface 24 (i.e., a nozzle radius of curvature 30 of 0). In various embodiments, the desired valve 10 performance characteristics can be achieved with a wide variety of transition surfaces 24.

[0027] Exemplary embodiments offset (60) the splitter 32 from the nozzle axis 42. Prior art devices 10 of which the inventors are aware axially align the nozzle axis 42 with the center of the splitter 32. In contrast, various embodiments offset (60) the nozzle axis 42 from the splitter 32 (e.g., offsetting the nozzle axis 42 from the center of the splitter face 38 or completely from the splitter face 38). Additionally, in various embodiments, the splitter 32 is configured such that the branching channels 34 are not uniform. Various embodiments use an offset splitter 32 to bias fluid flow toward the patient circuit 21 (e.g., fluid tubing, endotracheal tubes, and other fluid connections downstream of the valve 10), which provides certain physiologically desirable characteristics.

[0028] FIG. 3 illustrates a schematic of fluid flow through the device 10, according to an exemplary embodiment of the invention. Because the splitter 32 (also called a diverter) is not immediately in front of the nozzle 20, the fluid flows toward the lungs of the patient 62. Thus, the flow is urged toward the lungs (i.e., toward the patient 62) by the position of the splitter 32 without requiring a particular curvature on the transition surface 24. Additionally, the transition surface 24, which is also a step 26 in FIG. 3, is believed to help urge the flow toward the patient outlet 14 (e.g., toward the lungs). It is believed that the small step 26 creates a small area of ​​low pressure that helps pull the fluid toward the transition surface 24.

[0029] Returning to FIG. 2, various embodiments also provide asymmetric fluid flow paths 34. Additionally, the fluid flow paths 34 have different lengths and / or widths. Asymmetric fluid flow paths 34 with different dimensions provide desirable performance characteristics. For example, asymmetric bifurcation helps achieve clinically safe PIP, PEEP, RR and / or IE ratios.

[0030] Additionally, the valve 10 advantageously provides in-line fluid flow such that the fluid flow passages 34 of the inlet 12 and / or outlet 14 are parallel to (e.g., the same as) the major axis 44 of the device 10. In some embodiments, the nozzle axis 42 is the same as 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, the flow does not have to enter the device 10 at right angles, and the form factor of the device 10 creates a compact, simple, streamlined device 10 without parts that can catch and snag objects.

[0031] Various embodiments include a fluid expansion zone 18 distal to the inlet 12 of the device 10. The inventors believe that the fluid expansion zone 18 serves to induce turbulence that enhances performance stability in contrast to prior art expectations. Thus, in various embodiments, the device 10 is configured to generate and control turbulent fluid flow. This is in contrast to other prior art devices 10 that aim to reduce turbulence.

[0032] Various embodiments are configured to receive an air input of about 3 psi to about 5 psi and provide about 0 cmH2O to about 40 cmH2O to the patient.

[0033] 1C, 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 restriction area 50, channel depth 52, and nozzle width 46 can be adjusted to control the PIP for a desired clinical outcome.

[0034] Additionally, the exhaust throttling region 58 and / or the leg angles of the exhaust ports 16 can be adjusted to control the PEEP and IE ratios for a desired clinical outcome. In particular, the exhaust port angle of the outlet leg 54 and the exhaust port angle of the inlet leg 56 can be adjusted.

[0035] FIG. 4A illustrates a schematic of a fluid valve 10 according to an exemplary embodiment of the present invention. FIG. 4B illustrates a schematic of an example of airflow characteristics and exhalation parameters achieved through the exemplary valve 10 of FIG. 4A. As can be seen, the transition surface 24 can be a flat step 26. Additionally, as shown, various embodiments can position the diverter such that it does not intersect with the nozzle axis 42. It should be understood that the illustrated airflow characteristics are an example and are not intended to limit various embodiments of the present invention.

[0036] Figure 5A illustrates a schematic of a fluid valve 10 according to an exemplary embodiment of the present invention. Figure 5B illustrates a schematic of an example of airflow characteristics and exhalation parameters achieved through the exemplary valve 10 of Figure 5A. As shown, various embodiments may have multiple exhaust ports 16. It should be understood that the airflow characteristics shown are by way of example and are not intended to limit various embodiments of the present invention.

[0037] 6 shows a schematic of various performance parameters achieved by exemplary embodiments. It should be understood that the illustrated performance parameters are examples and are not intended to limit the various embodiments of the present invention.

[0038] 7A-9 are used to explain the effect of various embodiments of the valve 10 on breathing settings. Those skilled in the art will understand these terms. However, FIGS. 7A-9 are provided to explain the inventors' thoughts on how the valve 10 affects these breathing settings. Additionally, FIGS. 7A-9 may show example values, such as 20 LPM, which are not intended to limit the various embodiments but are instead shown as examples.

[0039] 7A-7C are schematic diagrams illustrating the effect of the valve 10 on the PIP according to an exemplary embodiment of the present invention. In general, the PIP (peak inlet pressure) is fairly well defined and correlates with the cross-sectional area of ​​the nozzle 20 (nozzle width 46 x channel depth) and the motive flow rate. In this example, FIGS. 7A-7C show a flow rate (e.g., 20 LPM) entering the inlet 12. It should be understood that the reference to 20 LPM is for illustrative purposes only and is not intended to limit the various embodiments. Various embodiments generate air jet velocities of approximately 100 m / s (depending on the device 10).

[0040] As shown in Figure 7A, the jet is held against the transition surface 24 until the patient backpressure rises to a point where the flow remains zero (as shown in Figure 7B) at the cross-section of the patient restriction 50 (shown in green). The fluid then flows to the exhaust port 16 (as shown in Figure 7C). At the point of flow changeover, the stagnation pressure that develops in the cross-sectional area of ​​the patient restriction 50 is known as the PIP.

[0041] PIP can be measured using patient monitor data from a patient airway pressure gauge or from a testing instrument that records this data as well as airflow. In Figure 7C, the backflow varies throughout the exhaust phase and does not have a predetermined reversal flow rate back into the inhalation cycle. Instead, the flow rate is a function of the pressure indicated by the circular blue arrow 51 that holds the jet in place.

[0042] Figures 8A-8B show diagrammatically the effect of the valve 10 on PEEP according to an exemplary embodiment of the invention. In general, PEEP (positive end-expiratory pressure) is more complex to regulate and depends more on geometrical aspects. As the fluid flows to the exhaust port 16, the low pressure recirculation "bubble 18" (blue 51) holds the jet until enough energy has dissipated and the "bubble 18" or vacuum lock can be broken by a backflow of turbulent air 53 (purple). The fluid then flows back towards the outlet 14 and towards the patient, and the process shown in Figures 7A-7C is repeated for another respiratory cycle.

[0043] In the embodiment shown in Figure 8B, the bubble 18 area and its collapse can be directly controlled using a variable set screw, allowing PEEP to be controlled over a wide range of values.

[0044] In various embodiments, the PEEP is The angle at which the main jet is deflected, - Cross-sectional area of ​​exhaust throttle 58, - the geometry of the "bubble 18" area, The angle of the legs of the exhaust port 16 (FIG. 8B does not have a branched exhaust port 16 and has no nozzle exit step 26) is affected by.

[0045] 9 shows a schematic of the effect of the valve 10 on the IE ratio setting, according to an exemplary embodiment of the present invention. The IE (inhale-exhale) ratio is the ratio of inhalation time to exhalation time. For example, an IE of 1:2 means that the exhalation portion is twice as long as the inhalation portion during one breath. The inhalation portion of the breathing time is essentially defined by the physiological requirements set by the physician during the design of the device 10.

[0046] Various embodiments include: ·RR (respiration rate) -TV (Ventilation volume) ·MV (amount)=RR×TV Inhalation time can be adjusted to adjust the parameters of

[0047] The orange arrow showing the cross-sectional area of ​​the exhaust restriction 58 partially modulates the expiratory rate. The more convoluted this pathway is, the greater the resistance and therefore the greater the IE ratio (slower exhalation). This dimension also controls the PEEP value to some extent, so the dimensions of this area must be adjusted together.

[0048] FIG. 10 shows a schematic of airway flow and airway pressure waveforms when the valve 10 is in use, according to an exemplary embodiment of the present invention. Starting at the BLUE dot (point A), the inhalation phase begins. The full power flow (i.e., the flow rate of the inlet 12 provided to the device 10 of clean gas (air / oxygen)) is preferentially attracted to the transition wall and flows towards the patient outlet 14. In some embodiments, the attraction to the patient's side wall may be caused by the "Coanda effect", where low pressure generated by high nozzle 20 velocity causes the fluid jet to tend to be directed towards the patient's wall. However, various embodiments may be configured to operate without using the Coanda effect. Ambient air is entrained through the exhaust port 16 during inspiration. Peak entrainment occurs at the moment the inhalation phase begins. As the inhalation phase progresses, entrainment gradually decreases until the switch-over point to expiration, where the entrainment value is approximately zero.

[0049] Patient exhalation begins when the jet reverses from the patient outlet 14 to the exhaust port 16. The inventors believe that the switch point occurs when the patient airway flow equals the motive force flow rate. This switch point can be thought of as an internal energy balance. For example, when the potential + kinetic energy in the inlet flow equals the potential + kinetic energy stored in the patient airway, the device 10 switches to the expiratory phase.

[0050] Explained another way, the device 10 operates in what may be considered an incompressible flow regime, and therefore the air entering the device 10 is equal to the air moving out of the device 10. Thus, when the patient airflow rate slows down to the same as the power flow rate, the air switches to the expiratory phase. Thus, in various embodiments, the inventors have not confirmed that the main jet is deflected towards the patient outlet 14 due to the "Coanda" effect, but suspect that the switching time (e.g., switching point B in FIG. 10) is defined by an internal energy balance. This energy balance is calculated by the Bernoulli equation and is defined by the cross-sectional area of ​​the "patient restriction 50".

[0051] Continuing from the green dot (point B), after the jet is deflected towards the exhaust port 16, the patient's airway airflow reverses and exits through the exhaust port 16 (along with the motive flow).

[0052] The peak exhaust 16 flow rate is: the internal resistance of the valve 10 as determined by its geometric shape; Resistance of the patient's airway, and Patient Airway Pressure is a function of .

[0053] As the exhaust 16 stage advances, the patient's airway pressure decreases, resulting in a decrease in total exhaust 16 flow.

[0054] As previously mentioned, the leg side of the exhaust port 16 is different from the leg side of the patient side. This part of the cycle appears to depend on the jet velocity as well as the low pressure recirculating "bubble 18" (shown as red arrows 61 in FIG. 10) created by the geometry of the valve 10 in this region. The stronger this "bubble 18" is, the lower the PEEP pressure will be.

[0055] As the patient's airway flow decreases, less of the "bubble 18" is forced into the recirculation zone, causing the bubble 18 to "pop", freeing the jet to return to the patient outlet 14 to begin the inhalation cycle again.

[0056] Various embodiments described herein are advantageously configured to automatically transition the patient from inhalation to exhalation, and vice versa. Thus, the device 10 may be said to oscillate between the fluid flow paths leading to the outlet 14 and the exhaust port 16 when coupled with a patient (e.g., a breathing patient controlled entirely externally by a ventilator). This is in contrast to some other embodiments that may operate as a switch having two or more stable states (e.g., bi-stable). Such a bistable switching device 10 requires an external trigger (e.g., external pressure applied by the patient initiating an inhalation or exhalation) to switch states (i.e., to switch flow paths). In various embodiments, the device 10 is configured to automatically return to the patient outlet 14 after the fluid flow has been diverted to the exhaust port 16. Thus, the device 10 may be described as a fluid oscillator.

[0057] 11A-11C show schematic diagrams of a device 10 according to an exemplary embodiment of the present invention. The device 10 is configured to reduce the concentration of an input fluid source 66 (e.g., oxygen or other gas). Although described with reference to FIGS. 11A-11C, it should be understood that all of the various embodiments discussed above may be coupled to the 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.

[0058] As shown in Figures 11A-11C, some embodiments may not include a fluid expansion zone 18. Alternatively or additionally, various embodiments may include a dilution nozzle 80. In various embodiments, 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). The dilution nozzle 80 may also be referred to as an inlet nozzle 80 in some embodiments. Thus, fluid passing through the dilution nozzle 80 (e.g., in a direction from the proximal end 8 toward the distal end 6) may be diluted with air received through the port 64.

[0059] Thus, one or more ports 64 may be adjacent to the dilution nozzle 20. The device 10 of FIGS. 11A-11C may otherwise include some or all of the features of the various embodiments described herein. The ports 64 may be referred to as "outlet side ports 64" or "exhaust side ports 64" to indicate their relative position with respect to a cross-sectional view (e.g., the outlet side port 64B is closer to the outlet 14 than the exhaust side port 64A). Similarly, the device may have an outlet side surface 74 and an exhaust side surface 76. In some embodiments, the ports 64 may be located distally with respect to the dilution nozzle 80 (e.g., as shown in FIGS. 11-14). However, in some other embodiments, the ports 64 may be located proximally with respect to the dilution nozzle 80.

[0060] The one or more ports 64 can provide several advantages. For example, the port 64 can operate a safety mechanism that limits pressure at the patient 62 side. In particular, the device 10 can limit the input gas (e.g., oxygen) flow rate through the device nozzle 20. When 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, fluid flow is directed from the port 64, which can be adjusted to provide an upper limit on the fluid flow rate through the device nozzle 20.

[0061] In contrast, one or more exhaust ports 16 of the device 10 are downstream of the device nozzle 20 and can assist in automatic transitions between fluid flow paths as described above (e.g., between the outlet 14 or exhaust port(s) 16). In various embodiments, the port(s) 64 are upstream of the device nozzle 20. The port(s) 64 can help control and cap the total amount of fluid flow passing through the device nozzle 20.

[0062] 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) may have a given FiO2 percentage (e.g., emergency personnel carry 95% medical grade oxygen FiO2, etc.). The fluid source 66 used by medical personnel tends to have a higher concentration of oxygen (e.g., 95% FiO2). Depending on the desired patient parameters output by the device 10, the preferred or acceptable range of FiO2 may 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 using air from the surroundings (i.e., ambient air having an oxygen concentration of about 21%). Thus, the dilution ports 64 are configured to allow air from the external environment to be introduced into the device 10 to dilute the input fluid (e.g., fluid through the inlet 12). The diluted fluid flows through the device nozzle 20 toward the patient.

[0063] In general, the fluid source 66 and associated equipment (e.g., regulator 68, fluid tubing, etc.) are configured to provide a given flow rate of fluid within the apparatus 10. For purposes of illustration, 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 non-oxygen containing fluid source 66.

[0064] Without the port, the flow rate from the fluid source 66 remains constant as the fluid flow transitions from the patient outlet 14 to the exhaust 16. Thus, the input fluid flow rate from the source remains constant even when the fluid is flowing towards the exhaust 16. The fluid flow is constant in various embodiments because the port 64 acts as a control flow switching the flow path from the outlet 14 to the exhaust 16 and vice versa. Thus, in various embodiments, when the patient 62 exhales, fluid from the source 66 is wasted. Thus, the exemplary embodiment uses ambient air to reduce the high concentration fluid source 66 and provide mixed / diluted air to the patient 62. In some embodiments, the port 64 can substantially dilute the fluid from the fluid source 66 (e.g., diluting the fluid from the fluid source 66 by 15%-60%).

[0065] Various embodiments may use, for example, an oxygen D cylinder (i.e., 340 liters) as the source. Depending on the amount of time the patient 62 is fluidly coupled to the fluid source 66, the oxygen source may run out (e.g., after 15-20 minutes). The dilution port 64 is configured such that the main flow from the inlet 12 draws in a fluid flow from the external environment. For example, the flow rate through the device 10 may be configured to be about 20 liters per minute. Without the dilution port, 20 liters per minute would be obtained from the source. However, an exemplary embodiment with a dilution portion may reduce the flow rate from the source (e.g., to 12 LPM) and draw in ambient air through the dilution portion (e.g., providing a total flow rate of 20 lpm to obtain a remaining 8 liters per minute). Thus, the exemplary embodiment reduces the fluid flow rate from the fluid source 66, extending the useful life of the fluid source 66. This is particularly advantageous in emergency situations (e.g., when a smaller fluid source is available).

[0066] 12A-12C are schematic illustrations of various configurations of biased airflow through inlet 12, according to exemplary embodiments of the present invention. FIG. 12A is schematic illustration of airflow entering through inlet 12 and being substantially aligned with device nozzle axis 42. Airflow may also be entrained 70 from outside device 10 through dilution port 64. As shown, entrained airflow 70 merges with the primary fluid flow entering through inlet 12. Although FIGS. 12B and 12C do not show entrained airflow 70, it should be understood that these embodiments also entrain airflow 70 from the environment or another source (unless port 64 is blocked).

[0067] While not 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 the outlet 14 of dilution nozzle 20 relative to the air outside of apparatus 10. This low pressure is created by the high velocity exiting dilution nozzle 20. The relatively high pressure outside apparatus 10 forces ambient air to flow into the relatively low pressure region of apparatus 10 where it joins the fluid jet (e.g., from fluid source 66) entering from inlet 12.

[0068] In various embodiments, Figure 12A depicts a fluid flow that is substantially parallel to the device nozzle axis 42. A fluid flow profile 72 is shown generally in Figure 12A. As shown with reference to Figures 12A-12C, the profile 72 can affect the bias of the fluid flow in a variety of ways. The inventors have found that the fluid flow profile 72 also affects the PIP and / or PEEP of the device 10 along with other end-patient parameters (e.g., IE ratio, etc.).

[0069] FIG. 12B shows the airflow entering through the inlet 12 generally toward the outlet sidewall 76 (at least in the illustrated view). This ultimately changes the position of the fluid flow relative to the nozzle 20. A fluid flow profile 72 is shown generally in FIG. 12B. A primary direction 78 of the airflow entering the device 10 is shown toward the outlet sidewall 76. Exemplary embodiments can achieve this direction of airflow by changing the relative orientation of the inlet 12 and / or 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 toward the outlet sidewall 76. Additionally or alternatively, the direction of the fluid flow may be changed by blocking one or more of the dilution ports 64. For example, some embodiments may block the outlet port 64A. The inventors believe this creates a low pressure region that urges the flow toward the outlet sidewall 76. Some embodiments may include a movable closure 82 (e.g., slidable by a medical practitioner's finger) over one or more of the ports 64. By closing one or more of the ports 64, the performance of the device 10 can be adjusted.

[0070] FIG. 12C shows generally that the primary direction of airflow 78 entering through the inlet 12 is toward the outlet sidewall 74. This ultimately changes the position of the fluid flow relative to the nozzle 20. A fluid flow profile 72 is shown generally in FIG. 12C. The primary direction of airflow 72 entering through the nozzle 20 is shown toward the patient side outlet 14. Exemplary embodiments can achieve this direction of airflow by changing the relative orientation of the inlet 12 and / or 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 toward the patient sidewall 74. Additionally or alternatively, the direction of the fluid flow may be changed by blocking one or more of the dilution ports 64. For example, some embodiments may block the patient side port 64B. The inventors believe that this creates a low pressure region that urges the flow toward the patient sidewall. Some embodiments may include a moveable closure 82 (e.g., finger slidable) over one or more of the ports 64. By closing one or more ports, the performance of the device 10 can be tuned.

[0071] By urging the fluid flow toward the patient side wall 74, the exemplary embodiment increases the PIP and / or PEEP, whereas by urging the fluid flow toward the exhaust side wall 76, the exemplary embodiment decreases the PIP and / or PEEP. The inventors have further discovered that blocking the port 64 has a different magnitude effect on the overall performance of the device 10.

[0072] Based on the above disclosure, it is apparent that various embodiments can adjust the fluid flow dynamics by blocking the dilution ports 64 and / or by adjusting the relative orientation of the dilution nozzle 80 with respect to the equipment nozzle 20. In various embodiments, the dilution nozzle 80 and the equipment nozzle 20 share a common plane (e.g., even when the inlet 12 is rotated such that the air flow direction is changed but the fluid flow remains substantially coplanar).

[0073] Some embodiments can be adjusted so that the inlet 12 is not aligned (e.g., perpendicular) with the device nozzle axis 42, such that the primary direction of the incoming airflow is perpendicular to the device nozzle axis 42. The inventors believe such a configuration is not preferred because the primary direction of the airflow is not directed towards the device nozzle 20, but instead hits other areas (e.g., the walls of the atrium 84 of the device 10). Backpressure caused by the flow hitting the wall and then spreading outward can cause inconsistent performance through the port, causing the port 64 to operate as an exhaust 16 instead of an aspiration / intake port 64.

[0074] In various embodiments, then: (1) both ports 64 are open and the device 10 functions smoothly and consistently; (2) The patient port 64 is blocked, increasing PIP and PEEP. (3) The exhaust port 64 is blocked, decreasing PIP and PEEP.

[0075] It should be understood that the various flow profiles 72 and fluid flow directions shown herein are for illustrative purposes and are not intended to limit the various embodiments. Indeed, the flow profiles 72 and fluid flow directions are shown for ease of explanation and are not meant to imply that the profiles 72 or directions do not or cannot vary from those shown.

[0076] FIG. 13 shows a schematic external view of device 10, according to an exemplary embodiment of the present invention.

[0077] FIG. 14 illustrates a schematic of an alternative embodiment of the apparatus 10, according to an exemplary embodiment. The apparatus 10 illustrated in FIG. 14 may be identical to any of the apparatus 10 described herein, but may further be coupled to a dilution connector 86. Additionally, a dilution nozzle 80 may be coupled to the inlet 12 of the apparatus 10 via fluid tubing 88 (e.g., with an optional flow meter 90). The dilution nozzle 80 may be configured to interface with a fluid source 66 (e.g., using standard fluid tubing and connections). The flow meter 90 aids in setting up the apparatus 10 to achieve a desired flow rate.

[0078] 12A-12C, the dilution nozzle 80 is in a dilution connector 86 that is not directly coupled to the device nozzle 20. Thus, the direction of airflow is not as likely to affect the performance of the device 10 as in the embodiment shown in FIGS. 12A-12C. Instead, the airflow toward the device nozzle 20 is more sensitive to the geometry of the inlet 12 and / or inlet nozzle 20. In some embodiments, the inlet 12 of the fluidic device 10 may include a nozzle 20 configured to regulate the flow of air within the device 10, similar to the dilution nozzle 80 (not shown in FIG. 14) shown and described with reference to FIGS. 12A-12C.

[0079] 15A-15C show schematic diagrams of the diluent connector 86 of FIG. 14 in accordance with an exemplary embodiment of the present invention. An adjustable closure 82 (e.g., a slider) on the upper section can be adjusted to control the amount of fluid taken up in tubing 88 entering the fluidic device 10. The device 10 shows stages of adjustment to achieve the final desired FiO2 and flow rate.

[0080] FIG. 16 illustrates a schematic cross-sectional view of an alternative embodiment of the apparatus 10 according to an exemplary embodiment. The apparatus 10 includes a nozzle switcher 94 that provides rapid adjustment between dilute fluid (e.g., from fluid entrained through port 64) and pure fluid (i.e., no entrained air) received from the source 66. Thus, in various embodiments, the apparatus 10 can transition (e.g., rotatably) between a dilute nozzle 80 and a non-dilute nozzle 81. The dilute nozzle 80 is coupled to the port 64. On the other hand, the non-dilute nozzle 81 does not include fluid access to the port 64. A user can easily switch between the dilute nozzle 80 and the non-dilute nozzle 81 by manual manipulation, for example, by rotating the nozzles 80, 81 using the rotatable transition mechanism 92 (e.g., protrusions, textured surface, etc.) such that the fluid flow path of the inlet 12 is aligned and fluidly coupled with the nozzle 80 or 81.

[0081] Thus, some embodiments may transition between nozzles 80, 81 and / or may use a moveable cover 82 to aid in air intake. Additionally, while only two nozzles are shown at 80, 81, it should be understood that the device may rotate through several different nozzles 80, 81 having a variety of different sized nozzles 80 and ports 64.

[0082] 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 be non-parallel to the device axis 44. However, various embodiments include a planar flow path from the inlet 12 to the device nozzle 20.

[0083] Figure 17 illustrates a schematic cross-sectional view of an alternative embodiment of the apparatus 10, in accordance with an exemplary embodiment. In particular, Figure 17 illustrates an apparatus having a planar flow path from the inlet 12 to the apparatus nozzle 20. The apparatus 10 includes a transition mechanism 92 that can be pressed to transition between a dilute nozzle 80 and a non-dilute nozzle 81. Thus, the dilute nozzle 80 or the non-dilute nozzle 81 can slide in line (e.g., parallel) with the fluid flow path from the inlet 12.

[0084] 18A-18C are schematic illustrations of details of the nozzle switcher 94 according to an exemplary embodiment. In various embodiments, the nozzle switcher 94 is integrated into the device 10 (e.g., as shown in FIGS. 16 and 17). However, the nozzle switcher 94 may be a separate component that couples to the device 10. FIG. 18A is a schematic illustration of a cross-sectional view of the nozzle switcher 94 according to an exemplary embodiment. FIG. 18B is a partial see-through view of the nozzle switcher 94 of FIG. 18A. In the view of FIG. 18B, the nozzle switcher 94 is rotated 90 degrees relative to FIG. 18A. FIG. 18C is a schematic illustration of a cross-sectional view of the nozzle switcher 94 of FIG. 18B. The switcher 94 may have a rotation axis 96 that is offset 91 from the longitudinal axis 44 of the device 10. A rotating portion 98 is configured to rotate about the rotation axis 96. Although not visible from this view, switcher 94 allows rotation through the various dilute and non-dilute nozzles 80 and 81 while keeping the flow paths of device 10 coplanar and substantially collinear.

[0085] 18B-18C show schematic placement of the switcher 94 in a captured flow configuration in which the switcher 94 is in a first configuration (also referred to as a dilution configuration). In the dilution configuration, the vented path 80A having an opening 102 to the port 64 is aligned with the fluid flow path of the device 10. The switcher 94 can be transitioned to a non-dilution configuration (not shown) in which the non-vented path 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 such that transition of the graspable mechanism 92 by a user causes rotation of the rotating portion 98 that aligns the vented path 80A or the non-vented path 81A with the fluid flow path of the device 10. To switch from a pure flow from the fluid source 66 to a diluted flow, the user can simply rotate the switcher 94. Although the switcher 94 is shown with 50% printed thereon, it should be understood that the various embodiments are not limited to 50% dilution. Indeed, various embodiments can achieve any desired percentage of diluted oxygen concentration (eg, 55%).

[0086] In various embodiments, the switcher 94 includes an alignment mechanism 100 (e.g., wall 100A and protrusion 100B) configured to align the passages 80A and / or 81A with the fluid flow path of the device 10. Additionally, the alignment mechanism 100 prevents over-rotation of the rotating portion 98. This allows a user to easily and reliably transition the switcher 94 between a first configuration (e.g., when the device nozzle 20 is fluidly coupled with the port 64) and a second configuration (e.g., when the device nozzle 20 is not fluidly coupled with the port 64). Additionally, the transition can occur without misalignment of the passages 80A and / or 80B with the fluid flow path of the device 10 due to the alignment mechanism 100 (e.g., the user rotates the rotating portion 98 until it can no longer rotate). The device 10 may also lock the first configuration and / or the second configuration such that a threshold force must be applied to transition the switcher 94 (e.g., it does not easily come out of the set configuration).

[0087] In various embodiments, the axis of rotation 96 is advantageously offset 91 such that passages 80A and 81A align with central axis 44 of device 10 upon rotation. Thus, device 10 can maintain a substantially planar fluid flow path. Additionally, exemplary embodiments can use small angular rotations (e.g., 45 degrees or less) to transition between the first and second configurations. Of course, various embodiments may require different angular rotations to transition between configurations (e.g., greater than 45 degrees).

[0088] FIG. 19 illustrates a process of mechanical ventilation using the device 10, according to an exemplary embodiment of the present invention. It should be noted that this method is substantially simplified from a more lengthy process that may typically be used. Thus, the method illustrated in FIG. 19 may have many other steps that one skilled in the art would likely use. Furthermore, some of the steps may be performed in a different order than shown, or simultaneously. Furthermore, in some embodiments, some of these steps may be optional. Thus, the process 1900 is merely illustrative of one process, according to an exemplary embodiment of the present invention. As such, one skilled in the art may modify the process accordingly.

[0089] The process 1900 begins at step 1902 with providing 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 to a breathing circuit 21 and an exhaust port 16 of a patient 62.

[0090] In step 1904, the inlet 12 of the device 10 is coupled to a fluid source 66 and / or a mechanical ventilator. In step 1906, the outlet 14 is coupled to the breathing circuit 21 of the patient 62. Steps 1904 and 1906 may be performed in an order different than that shown in FIG.

[0091] At step 1908, ventilation flow through the device 10 is provided to achieve the desired patient ventilation parameters. Advantageously, various embodiments are configured to automatically transition the patient 62 from inhalation to exhalation and vice versa. Thus, the device 10 may be said to oscillate between the fluid flow path 34 leading to the outlet 14 and the fluid flow path 34 leading to the exhaust port 16 when coupled with the patient 62 (e.g., when breathing is fully controlled externally by the ventilator). Additionally or alternatively, some embodiments may operate as a switch having two or more stable states (e.g., bistable). Such a bistable switching device 10 requires an external trigger (e.g., external pressure applied by the patient initiating inhalation or exhalation) to switch states (i.e., to switch flow paths). In various embodiments, the device 10 is configured to automatically return to the patient outlet 14 after the fluid flow has been diverted to the exhaust port 16. Thus, the device 10 may be described as a fluid oscillator. The device 10 can operate in a given mode based on the mode of the ventilator (eg, controlled ventilation, assisted ventilation, supported ventilation).

[0092] In various embodiments, the device 10 may be configured to generate desired patient ventilation parameters. FIG. 10 illustrates a schematic representation of modulated patient parameters for various devices 10. For example, the device 10 may be configured to generate a target PIP of about 18 cmH2O to 30 cmH2O in the patient circuit 21. Air is then bled out of the exhaust port until a PEEP of about 6 cmH2O to 14 cmH2O is achieved in the patient circuit 21 after the target PIP is reached. The steps of bleed air out of the outlet 14 and out of the exhaust port 16 define a respiratory rate for the patient 62 of about 10 breaths per minute to about 30 breaths per minute. Some embodiments may define a respiratory rate of about 16 breaths per minute to about 30 breaths per minute. The tidal volume delivered from the device 10 to the patient 62 may be about 200 ml to about 500 ml, or about 220 ml to about 465 ml. In some embodiments, the device 10 is configured to provide an IE ratio of about 1.5 to 2.0. The device 10 may receive air input at a pressure of about 3 psi to about 5 psi. Various embodiments can be used to control ventilation or assist ventilation of a patient.

[0093] The process then proceeds to step 1910, which dilutes the ventilation flow from the source 66. In some embodiments, the ventilation flow can be automatically diluted, for example when the port 64 is installed in the device 10 and opened. Thus, in some embodiments, steps 1910 and 1908 are performed simultaneously. However, in some other embodiments, dilution of the air flow can be performed by opening the port 64 (e.g., by using the moveable closure 82 of FIG. 12B, which may be slidable by a medical practitioner's finger), coupling the dilution connector 86 to the device 10 (e.g., as shown in FIGS. 15A-15C), and / or using a nozzle switcher 94 (e.g., as shown in FIGS. 16-18C). In various embodiments, the device 10 includes at least one port 65 having an opening to an environment external to the device 10, and the device is configured to allow ambient fluid to enter the device through the port and mix with the source fluid.

[0094] In step 1912, the process queries whether to disconnect the patient from ventilation. If the patient is not ready to be disconnected from ventilation, the process may return to step 1908, and the steps continue to provide ventilation flow. However, if the medical practitioner decides to change the ventilation flow parameters, the process may optionally return to step 1902, and the steps provide a different version of the device 10 configured to provide different ventilation parameters. Processes 1902-1912 may then be repeated. If the patient is ready to be disconnected from ventilation, the process proceeds to step 1912, and disconnects the fluidic device 10 from the patient circuit 21. The process then ends.

[0095] It will be apparent that the device 10 may operate according to a variety of parameters. Moreover, various embodiments are advantageously operated passively, i.e., the device 10 switches between directing the airflow 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 to assist with the switch.

[0096] 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, a reference to a "port" in the singular includes a plurality of ports, and a reference to an "exhaust outlet" in the singular includes one or more exhaust outlets and equivalents known to those of ordinary skill in the art. Thus, in various embodiments, any reference to the singular includes the plural, and any reference to more than one component can include the singular.

[0097] While various embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily envision a variety of 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 such variations and / or modifications is deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described and illustrated herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications for which the teachings of the present invention are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein.

[0098] Thus, the foregoing embodiments are presented by way of example only, and it is to be understood that, within the scope of the appended claims and their equivalents, the embodiments of the invention may be practiced otherwise than as specifically described and claimed. Exemplary embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. Moreover, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent. The disclosed embodiments, or portions thereof, may be combined in ways not listed above and / or not explicitly claimed. Thus, one or more features from the various disclosed examples and embodiments may be combined in various ways. For example, it is to 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.

[0099] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The operations performed as part of a method may be ordered in any suitable manner. Thus, while shown as sequential operations in the exemplary embodiments, embodiments may be constructed in which operations are performed in an order different from that shown, which may include performing some operations simultaneously.

[0100] While the above description discloses various exemplary embodiments of the present invention, it will be apparent to those skilled in the art that various modifications can be made which achieve several of the advantages of this invention without departing from the true scope of the invention.

Claims

1. A fluid device, An inlet configured to receive fluid from a pressurizing source, A device nozzle having a device nozzle axis, device nozzle length, and device nozzle width, A transition surface which is part of a patient fluid path leading to an outlet connected to a patient, wherein the inlet, the nozzle and the outlet share a fluid path in the same plane, The apparatus comprises at least one port having an opening to the external environment, wherein the apparatus is configured such that ambient fluid enters the apparatus through the port and mixes with a source fluid from the inlet to define a dilution fluid mixture, and the apparatus is configured such that the dilution fluid mixture enters the apparatus nozzle. A closure for at least one port, the closure being adjustable to open and close, and the device being configured such that closing the port biases the fluid flow through the device; A fluid device equipped with the following features.

2. The fluid apparatus according to claim 1, wherein the inlet has a dilution nozzle that defines the dilution nozzle axis.

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

4. Multiple ports, Each of the plurality of ports has a closure, each closure is adjustable to open and close, and the device is configured such that closing the port biases the fluid flow through the device, A fluid apparatus according to any one of claims 1 to 3, further comprising:

5. The fluid apparatus according to claim 4, wherein PIP and PEEP are selectively adjustable by closing and / or opening one or more of the plurality of ports.

6. The fluid apparatus according to any one of claims 1 to 3, wherein the inlet and the apparatus nozzle are integrally formed.

7. The fluid apparatus according to any one of claims 1 to 3, wherein the inlet has a dilution nozzle, and the diameter of the dilution nozzle narrows from the proximal end to the distal end.

8. A stepped surface which is part of a second fluid path leading to an exhaust port, A splitter that divides a first fluid path and a second fluid path, the splitter being asymmetrical with respect to the nozzle axis, The fluid apparatus according to claim 1, further comprising:

9. The fluid apparatus according to claim 1, further comprising a fluid expansion zone distal to the inlet.

10. A method of mechanical ventilation, Connecting a fluid valve between the patient's breathing circuit and a pressurizing source, wherein the fluid valve is An inlet configured to receive fluid from a pressurizing source, A device nozzle having a device nozzle axis, device nozzle length, and device nozzle width, The apparatus comprises at least one port having an opening to the external environment, wherein the apparatus is configured such that ambient fluid enters the apparatus through the port and mixes with a source fluid from the inlet to define a dilution fluid mixture, and the apparatus is configured such that the dilution fluid mixture enters the apparatus nozzle. A transition surface which is part of the patient fluid pathway leading to an outlet connected to the patient, A stepped surface which is part of the second fluid path leading to the exhaust port, The invention comprises a splitter that divides a first fluid path and a second fluid path, the splitter being asymmetrical with respect to the nozzle axis, The inlet, the nozzle, and the outlet share a fluid path in the same plane. Connecting a fluid valve, To supply airflow to the inlet of the valve, The means of releasing air from the outlet toward the patient, such that the release of the air from the valve generating a target PIP of approximately 18 cmH2O to 30 cmH2O is achieved within the patient circuit. After reaching the target PIP, air is discharged from the exhaust port until a PEEP of approximately 6 cmH2O to 14 cmH2O is achieved in the patient circuit, wherein the step of discharging air from the outlet and the exhaust port specifies a respiratory rate of approximately 10 to 30 breaths per minute. A method that includes this.

11. The fluid apparatus according to claim 9, wherein the fluid expansion zone causes the fluid flow to become turbulent.

12. The fluid apparatus according to claim 1 or 8, wherein the tidal volume delivered from the apparatus to the patient is approximately 200 ml to 500 ml.

13. The fluid apparatus according to claim 8, wherein the apparatus includes a plurality of exhaust ports.

14. The fluid apparatus according to claim 1, wherein the transition surface leading to the outlet has a radius of curvature.

15. The fluid apparatus according to claim 1, wherein the transition surface is stepped.

16. The fluid apparatus according to claim 1, wherein the transition surface is flat.

17. The fluid apparatus according to claim 8, wherein the apparatus is configured such that the splitter biases the fluid flow toward the outlet.

18. The fluid apparatus according to claim 8, wherein the second fluid path leading to the exhaust port is asymmetrical with respect to the first fluid path leading to the outlet.

19. The fluid apparatus according to any one of claims 1 to 3, 8, wherein the apparatus is configured to provide an IE ratio of about 1.5 to 2.

0.

20. The fluid apparatus according to claim 1 or 8, further comprising a dilution connector having a dilution portion, wherein the dilution connector is connected to the apparatus using fluid piping, and the inlet has a dilution nozzle defining a dilution nozzle axis, the dilution nozzle being part of the dilution connector.

21. The fluid device according to claim 8, wherein the fluid device is configured to vibrate the fluid flow between the patient outlet and the exhaust port.

22. The fluid apparatus according to claim 1 or 8, further comprising a nozzle switcher configured to transition the apparatus between a first configuration in which the apparatus nozzle is fluidly coupled to the port and a second configuration in which the apparatus nozzle is fluidly coupled to the port.

23. The fluid apparatus according to claim 22, wherein the nozzle switcher transitions from the first configuration to the second configuration by rotating the transition mechanism, and the rotation is 45 degrees or less.

24. The apparatus according to claim 23, wherein the rotation axis of the switcher is offset from the central axis of the apparatus, or the first configuration includes fluid coupling of the apparatus nozzle to a vent having an opening to the port, or the second configuration includes fluid coupling of the apparatus nozzle to a passage having a shutoff element for the port.

25. The method according to claim 10, wherein the apparatus includes a plurality of exhaust ports.

26. The method according to claim 10, wherein the transition surface leading to the outlet has a radius of curvature.

27. ​​The method according to claim 10, wherein the transition surface is flat.

28. The method according to claim 10, wherein the fluid device is configured to vibrate the fluid flow between the patient outlet and the exhaust port.

29. The device further comprises a nozzle switcher configured to move 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 transitions from the first configuration to the second configuration by rotating the transition mechanism, and the rotation is 45 degrees or less. The rotation axis of the switcher is offset from the central axis of the device, or the first configuration includes fluid coupling of the device nozzle to a vent having an opening to the port, or the second configuration includes fluid coupling of the device nozzle to a passage having a shut-off element for the port. The method according to claim 10.

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