Device for ventilation and related method

Abstract

To provide a device and method for ventilation and respiration.SOLUTION: A ventilation device includes a fluid amplifier including one or more coaxially aligned components. In this case, there is no movable component in the inside. In another embodiment, the device and related method are, for example, for treatment of a patient in need of ventilation after infection with coronavirus COVID-19.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to the field of healthcare, and in particular to ventilation.

[0002] Background of the Disclosure All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description contains information that may be useful in understanding the present invention. No admission is made that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any of the publications specifically or implicitly referenced are prior art.

[0003] Mechanical ventilation can be a critical component of intensive care services for patients, and if mechanical ventilation is not used appropriately or safely, the consequences can be devastating. However, the recent challenges of responding to the global coronavirus COVID-19 pandemic have highlighted the great need for ventilators designed to be effective, reliable, and readily manufactured and used where needed. During the COVID-19 pandemic, there was a significant shortage of mechanical ventilators due to an unexpected and sudden increase in patients suffering from life-threatening respiratory failure. There was an immediate need and shortage of supply for effective, inexpensive, and easy-to-use ventilators and resuscitators. For example, in the United States, during COVID-19, there was a great immediate need for effective, inexpensive, and easy-to-use ventilators and resuscitators to fill the gap during respiratory failure episodes in non-ICU settings (ambulances, emergency rooms, chronic convalescent care units) and within ICUs, when fully equipped ventilators were in short supply. Alternatively, for example, such ventilators or resuscitators may be needed in the future during local epidemics or in low-resource settings. Therefore, there is a need in the art for new and effective ventilation devices and related components.

[0004] Brief Summary of the Invention Various embodiments include a device having a fluid amplifier with multiple coaxially aligned components. In one embodiment, the fluid amplifier has a channel depth for controlling the pressure and / or volume of gas moving through the device. In another embodiment, the channel depth influences the user's breathing rate. In another embodiment, the channel depth includes teardrop-shaped channels for stabilizing the incoming oxygen gas. In another embodiment, the channel depth includes inspiratory and / or expiratory phase channels. In another embodiment, the fluid amplifier has a nozzle width for controlling the velocity of gas moving through the device. In another embodiment, the fluid amplifier ventilates the user through fluidics and pressure capacitance. In another embodiment, the fluid amplifier provides a breathing rate between 2 and 200 bpm. In another embodiment, the fluid amplifier provides a breathing rate between 10 and 40 bpm. In another embodiment, the fluid amplifier provides a breathing rate between 15 and 35 bpm. In another embodiment, the fluid amplifier is color-coded relative to the desired pressure. In another embodiment, the fluid amplifier utilizes an internal geometry and gas flow rate to provide a desired peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and inspiratory-expiratory ratio (IE) to a user. In another embodiment, the fluid amplifier is connected to a gas source. In another embodiment, the fluid amplifier is connected to a gas source by oxygen tubing. In another embodiment, the fluid amplifier has a barbed and / or threaded connector that connects to the oxygen tubing. In another embodiment, the coaxially aligned components include a fluid inlet, a nozzle, a bias ported surface, a non-bias ported surface, an exhaust, a splitter, an outlet, a channel depth, and / or an aero offset. In another embodiment, the fluid amplifier utilizes a laminar airflow design. In another embodiment, the fluid amplifier is adapted to provide emergency mechanical ventilation. In another embodiment, the device is part of an overall treatment plan for infection with coronavirus COVID-19. In another embodiment, the device is disposable. In another embodiment, the coaxially aligned components are modular in design.In another embodiment, the device may be modified and / or adjusted by one or more geometries to achieve a desired set of parameters. In another embodiment, the device may be modified by one or more of the following geometries to achieve a desired set of parameters: nozzle width, channel depth, bias port attachment surface radius, non-bias outlet shape, opening between bias and non-bias channels, and aero offset between the nozzle outlet and the start of the radius. In another embodiment, the devices are one of a separate set that may be differently sized and / or labeled to identify which device best fits the patient's needs. In another embodiment, the patient's needs include measuring peak inspiratory pressure (PIP) levels, positive end-expiratory pressure (PEEP), and / or respiratory rate (RR). In another embodiment, the fluid amplifier is integrated into the flow-generating device. In another embodiment, the fluid amplifier is connected to and / or integrated into a bag valve mask (BVM). In another embodiment, the fluid amplifier provides a PIP of 5-50 cmH2O. In another embodiment, the fluid amplifier provides a PEEP of 2-30 cmH2O. In another embodiment, the fluid amplifier utilizes a turbulent air design.

[0005] Another embodiment includes a kit having a device with a fluid amplifier adapted for ventilation of a subject. In another embodiment, the fluid amplifier has one or more coaxially aligned components. In another embodiment, the fluid amplifier has a fluid inlet and an outlet. In another embodiment, breathable gas is supplied to the fluid inlet. In another embodiment, the fluid inlet has a barbed fitting. In another embodiment, the fluid amplifier is connected to a gas source by oxygen tubing. In another embodiment, the flow rate of the gas source can be controlled by an upstream flow control valve. In another embodiment, the fluid amplifier has a channel depth to control the volume and / or pressure of gas moving through the device. In another embodiment, the channel depth includes teardrop-shaped channels to stabilize the incoming oxygen gas. In another embodiment, the channel depth includes inspiratory phase channels and / or expiratory phase channels. In another embodiment, the fluid amplifier has a nozzle width to control the velocity of gas moving through the device. In another embodiment, the fluid amplifier ventilates a user through a mechanism of fluidics and pressure capacitance. In another embodiment, the fluid amplifier provides a respiratory rate (RR) of 5 to 500 bpm. In another embodiment, the kit includes a low-pressure fluid amplifier, a medium-pressure fluid amplifier, and / or a high-pressure fluid amplifier. In another embodiment, the kit includes a fluid amplifier with a RR of 10-19 bpm, a fluid amplifier with a RR of 20-27 bpm, and / or a fluid amplifier with a RR of 28-50 bpm. In another embodiment, the kit includes one or more color-coded fluid amplifiers as part of an overall protocol for treating a patient's severe pulmonary disease. In another embodiment, the device is operably connected to a subject for the inspiratory and expiratory phases of ventilation. In another embodiment, the kit includes a pressure relief valve (PRV), a pressure indicator, an anti-asphyxiation valve, a filter, and / or oxygen tubing. In another embodiment, the kit includes an ASV, a manometer, and / or a pressure limiter. In another embodiment, the kit includes a low-pressure fluid amplifier, a medium-pressure fluid amplifier, and a high-pressure fluid amplifier.In another embodiment, the device provides pressure-cycled mechanical ventilation.

[0006] Another embodiment includes a method of treating a patient having an adverse condition, the method comprising providing a ventilation device having a fluid amplifier with one or more coaxially aligned components, and treating the patient with ventilation. In another embodiment, the fluid amplifier has one or more of the following operably connected components: a fluid inlet, a nozzle, a bias port attached surface, a non-bias port attached surface, an exhaust, a splitter, an outlet, a channel depth, and an aero offset. In another embodiment, the adverse condition is respiratory-related. In another embodiment, the adverse condition is infection with coronavirus COVID-19. In another embodiment, the ventilation device has one or more color-coded fluid amplifiers with different pressure intensities. In another embodiment, the treatment is part of an overall protocol having a green-coded fluid amplifier with a respiratory rate (RR) intensity of 15-18 bpm, a yellow-coded fluid amplifier with a RR intensity of 19-26 bpm, and / or a red-coded fluid amplifier with a RR intensity of 27-30 bpm. In another embodiment, the fluid amplifier has one or more internal channels. In another embodiment, one or more internal channels are visible to the user when viewed from the outside of the device. In another embodiment, the ventilation device is digitally stored to allow for mass production on demand when needed. In another embodiment, the ventilation device is digitally transmitted and stored to allow for custom manufacturing for use in specific patients and / or patient populations. In another embodiment, the ventilation device is printed at or near the point of use for treatment of specific patients and / or patient populations. In another embodiment, the fluid amplifier is a monostable design. In another embodiment, the fluid amplifier is a bistable design. In another embodiment, the adverse condition is sleep apnea. In another embodiment, the fluid amplifier provides continuous positive airway pressure (CPAP). In another embodiment, the fluid amplifier provides a peak inspiratory pressure (PIP) of 9 cmH2O, a positive end-expiratory pressure (PEEP) of 7 cmH2O, and / or a CPAP of 8 cmH2O. In another embodiment, the fluid amplifier provides pressure-cycled mechanical ventilation.In another embodiment, the treatment is for a mammal.

[0007] Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, various embodiments of the invention.

[0008] DESCRIPTION OF THE DRAWINGS Exemplary embodiments are illustrated in the referenced drawings. It is intended that the embodiments and figures disclosed herein be considered illustrative and not restrictive. [Brief explanation of the drawings]

[0009] [Figure 1] 1 illustrates an example of a fluid amplifier device according to various embodiments herein. Referring to FIG. 1, the fluid amplifier has the following components: fluid inlet 101, nozzle 102, bias ported surface 103, non-bias ported surface 104, exhaust 105, splitter 106, outlet 107, channel 108, and aero offset 109. In one embodiment, the device is a coaxial fluid oscillator that functions as a mechanical ventilator. [Figure 2] 10 shows a flowchart according to various embodiments herein illustrating an example protocol for a ventilation and assessment process for a patient using one or more devices having fluid amplifiers with one or more coaxially aligned components. As described further herein, the protocol may begin with the use of a yellow-coded fluid amplifier 111 and then potentially change to other color-coded fluid amplifiers depending on whether adequate ventilation to the patient is confirmed. [Figure 3]1 illustrates an example of a constant-flow, pressure-cycled, single-use ventilator designed to provide emergency mechanical ventilation, according to one embodiment herein. Three examples of color-coded fluid amplifiers are shown, including a green-coded fluid amplifier 110, a yellow-coded fluid amplifier 111, and a red-coded fluid amplifier 112. While the yellow fluid amplifier 111 is shown inserted into the device for ventilation, potentially, each of the various color-coded fluid amplifiers may be selected and inserted into the ventilation device for use depending on the desired ventilation parameters, as described further herein. According to various embodiments herein, a pressure relief valve 113, a pressure indicator 114, an anti-asphyxiation valve 115, and / or a filter 116 may also be incorporated. In one embodiment, the filter 116 is a heat and moisture exchange HEPA filter. In another embodiment, the pressure indicator 114 has a visual indicator for the user. According to another embodiment, a kit is provided that includes one or more fluid amplifiers and tubing 117. [Figure 4] 1 illustrates the inspiration phase of a fluid amplifier according to various embodiments herein. [Figure 5] 1 illustrates an exhalation phase of a fluid amplifier according to various embodiments herein. [Figure 6] 1 illustrates some results of performance testing according to various embodiments herein, including waveforms showing the results of a fluid amplifier during operation, in this case for the fluid amplifier coded in red in the inset. [Figure 7] 1 illustrates some results of performance testing according to various embodiments herein. The figure includes waveforms showing the results of a fluid amplifier during operation. In this case, the waveforms are for the fluid amplifier coded yellow in the insert. [Figure 8] 10 illustrates the ventilator and valve reconnected to the test lung, according to various embodiments herein. [Figure 9]1 illustrates an example of a fluid amplifier attached to a face mask 118 that can be used by a patient for breathing, according to various embodiments herein. [Figure 10] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 11] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 12] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 13] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 14] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 15] 1 illustrates an example of a fluid amplifier according to various embodiments herein. [Figure 16] 1 illustrates an example of a fluid amplifier according to various embodiments herein. The dotted circled area indicated by the numeral 17 is shown in more detail in FIG. 17 herein. The dotted circled area indicated by the numeral 18 is shown in more detail in FIG. 18 herein. [Figure 17] 17 shows an example of a fluid amplifier according to various embodiments herein. FIG. 17 shows in more detail the area also shown in FIG. [Figure 18] 18 shows an example of a fluid amplifier according to various embodiments herein. FIG. 18 shows in more detail the area also shown in FIG.

[0010] Detailed Description All references, publications, and patents cited herein are incorporated in their entirety by reference as if fully set forth. Unless otherwise specified, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Kleinstreuer et al., Modern Fluid Dynamics: Basic Theory and Selected Applications in Macro- and Micro-Fluidics (Springer, 2009 ed.); Hornyak et al., Introduction to Nanoscience and Nanotechnology, CRC Press (2008) provide those skilled in the art with a general guide to many of the terms used in this application. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein that could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described.

[0011] As used herein, the terms “coaxial,” “in-line,” and “coaxially aligned” generally refer to two or more components oriented or positioned to have a common axis. According to various embodiments herein, for example, a device with coaxially aligned components can have a fluidic amplifier with one or more coaxially aligned components in one channel, e.g., for the inspiratory phase of ventilation, and one or more coaxially aligned components in another channel, e.g., for the expiratory phase of ventilation. In one embodiment, the fluidic amplifier with one or more coaxial components is a monostable fluidic amplifier. In another embodiment, the fluidic amplifier with one or more coaxial components is a bistable fluidic amplifier. Furthermore, as used herein, “coaxially aligned” refers to the general orientation or location of the common axis, rather than the precise orientation or location. The present invention is in no way limited to precise coaxial alignment.

[0012] As used herein, the term "ventilator" includes ventilators, resuscitators, and respirators. As will be readily apparent to those skilled in the art, various terms related to ventilation have evolved over time in the relevant field, and the term "ventilator" may, in some cases, be used interchangeably to refer to multiple devices related to ventilation. The term "ventilator," as used herein, is not intended to limit the invention to devices narrowly defined as literal ventilation devices.

[0013] As used herein, the abbreviation "BVM" means bag valve mask.

[0014] As used herein, the abbreviation "PIP" means peak inspiratory pressure.

[0015] As used herein, the abbreviation "PEEP" means positive end-expiratory pressure.

[0016] As used herein, the abbreviation "RR" means respiratory rate.

[0017] As used herein, the abbreviation "IE" means inspiration to expiration ratio.

[0018] As used herein, the abbreviation "CPAP" means continuous positive airway pressure.

[0019] As used herein, "laminar airflow" refers to a process in which air is manipulated to move at the same speed and in the same direction with no or minimal airflow crossover in a given space. Similarly, "laminar airflow design" can refer, for example, to a device that includes one or more channels designed to have no or minimal airflow crossover in a given space.

[0020] As used herein, "inspiration" refers to the process of taking in air during breathing.

[0021] As used herein, "exhalation" refers to the process of expelling air during breathing.

[0022] As used herein, "treatment" or "therapy" should be understood to include any indication of success in curing, alleviating, or ameliorating an injury, condition, or symptom. This may include parameters such as: attenuation, mitigation, reduction of symptoms, slowing the rate of degeneration or decline, mitigating the debilitating end point of degeneration; improving the physical or mental well-being of the patient; or, in some circumstances, preventing the onset of disease.

[0023] As used herein, "diagnosis" or "diagnosis" means determining the nature or identity of a condition or disease. Diagnosis may involve a determination as to the severity of the disease.

[0024] As used herein, "prognostic" or "prognostic" means predicting the outcome or prognosis of a disease.

[0025] As used herein, the term "normal subject" refers to a population that, when taken as a whole or average, has an average incidence amount.

[0026] As used herein, the term "fluid amplifier" or "amplifier" or "fluidic amplifier" can refer to any change in the magnitude or vector of a fluid. For example, an "amplifier" can give a portion of an original input a value that is equal to or greater in magnitude and / or vector than the original input.

[0027] As described herein, various embodiments relate to the fields of ventilation and fluid amplification. As will be readily apparent to one skilled in the art, fluid amplification can be useful for many purposes in addition to the medical device or ventilator industry and can be used in conjunction with a variety of purposes across a variety of technical fields, and is not intended to be limited to use solely as a medical device or ventilator.

[0028] Similarly, as will be apparent to those skilled in the art, fluid amplification may be useful in a variety of professions and environments, and applications are in no way intended to be limited to ventilation in a standard hospital setting, or to the specific ventilation or respiratory conditions and settings listed herein. For example, various embodiments herein include devices that may be used by cardiologists. Or, for example, various embodiments herein include devices that enable emergency ventilation and / or resuscitation by first responders. Similarly, in another embodiment, the device enables ventilation in austere environments. According to another embodiment, the device may be used by design engineers in mechanical design, process control and power devices, and / or safety devices. Similarly, as will be readily apparent to those skilled in the art, various embodiments herein may be used in conjunction with and / or incorporated into CPAP (Continuous Positive Airway Pressure) therapy.

[0029] As disclosed herein, the COVID-19 coronavirus pandemic has highlighted the need for and shortage of ventilators and resuscitators designed to be rapidly manufactured and used when needed while still having the ability to operate effectively. Some of the challenges have resulted from a lack of modularity for specific geometries in the design of ventilators and related device components, as well as the lack of the ability to timely and efficiently manufacture customized ventilators or related components for specific patients, including clinical settings. In one embodiment, a device for providing ventilation has modular and / or coaxial components. In another embodiment, the device includes a fluidic amplifier. In another embodiment, the device may be scaled up or down in size and geometry to accommodate desired ventilation parameters. As will be readily apparent to those skilled in the art, while various examples of color-coded fluidic amplifiers are described herein, the present invention is in no way intended to be limited to devices constrained by these specific example geometries, sizes, and dimensions, which may be modified depending on the desired ventilation parameters. For example, according to various embodiments herein, the device can be scaled down to operate at the capacity of a microfluidic device. Or, for example, the device may be scaled to operate at the capacity of a gigafluidic device. Similarly, as will be readily apparent to those skilled in the art, while various examples of color-coded fluidic amplifiers are described herein, the present invention is in no way intended to be limited to devices constrained to these example geometries, sizes, and dimensions, which may be modified in the interest of providing modularity and greater manufacturing efficiency. For example, a device may adapt and adopt specific geometries and dimensions to more easily interface with existing commercially available accessories in the medical field. Alternatively, for example, a device may adopt specific geometries and dimensions to have the capacity to be rapidly manufactured and used as needed by medical personnel in a pandemic, e.g., by modularizing specific geometries in the design of ventilators and related device components.

[0030] In one embodiment, the use of a ventilation device in conjunction with a protocol that increases respiratory rate allows clinicians to rapidly assess respiratory mechanics without the need for complex monitors or resources. In another embodiment, the protocol provides a wide variety of pressure profiles.

[0031] In one embodiment, the device has a fluid amplifier with one or more components aligned coaxially. In another embodiment, the device functions without internal moving components. In another embodiment, the device provides a fundamentally robust fluid amplifier that can function without internal moving components that align in-line with the connecting pipes / tubes of the system. In another embodiment, the device is a coaxial fluid amplifier. In another embodiment, the fluid amplifier provides air ventilation to a user. In another embodiment, the device is part of an overall treatment plan for a patient following infection with coronavirus COVID-19. In one embodiment, the device is 3D printed. In another embodiment, the device is injection molded and / or milled.

[0032] In another embodiment, the fluid amplifier can be incorporated into and / or connected to a flow-generating device. The flow-generating device can be manually operated, such as a bag valve mask ("BVM"). In another embodiment, the fluid amplifier is incorporated into the manually operated flow-generating device itself. According to various embodiments herein, the fluid amplifier may be used to enhance existing pressure safety systems to increase safety for the user.

[0033] In one embodiment, the device comprises a monostable fluidic amplifier. In another embodiment, the device comprises a bistable fluidic amplifier.

[0034] In another embodiment, the device comprises a ventilation apparatus with one or more components coaxially aligned. In another embodiment, the device is for use as an in-line coaxial mechanical ventilator. In another embodiment, the device is used as a mechanical actuator in industrial and / or robotic applications. In another embodiment, the device is used as a component of a medical instrument. In another embodiment, the device is used as a component of a blood pump. In another embodiment, the device is used as a component of a gas flow monitor device. In another embodiment, the device is used as a component of a power generation device. In another embodiment, the device is used as a component of a pressure relief device and / or pressure maintenance device. In another embodiment, the device is used in an MRI environment.

[0035] According to various embodiments herein, the devices may be manufactured by one or more techniques including, but not limited to, machining, casting, additive manufacturing (3D printing), vacuum forming, and / or injection molding.

[0036] In one embodiment, the device has a fluidic amplifier with one or more coaxially aligned components, where the device is adapted to be simple and robust enough to be manufactured and used as a disposable mechanical ventilator.

[0037] According to one embodiment, the device can be modified and / or adjusted by one or more geometries to obtain a desired set of parameters. In another embodiment, the one or more geometries include one or more of the following: width of nozzle 102, depth of channel 108, radius of bias port attachment surface 103, shape of non-bias outlet, opening between bias and non-bias channels, and aero offset 109 between nozzle 102 outlet and start of radius. In another embodiment, the shapes of the nozzle and various channels are adjustable geometries to obtain the desired parameters.

[0038] In one embodiment, the fluid amplifier has one or more coaxial components, the one or more coaxial components having dimensions adapted to provide a desired inhalation-to-exhalation ratio (IE) for ventilation by the patient. In another embodiment, the adapted dimensions include one or more of the following: nozzle 102 width, nozzle 102 depth, edge radius, channel 108 angle, channel 108 depth, and channel 108 width. In another embodiment, the IE is further modified by gas flow rate. In another embodiment, the IE is further modified by fluid properties.

[0039] In one embodiment, the device includes a fluid amplifier with multiple coaxially aligned components. In another embodiment, the multiple coaxially aligned components include one or more of the following: a fluid inlet 101, a nozzle 102, a bias ported surface 103, a non-bias ported surface 104, an exhaust 105, a splitter 106, an outlet 107, a channel 108, and an aero offset 109. In another embodiment, the fluid amplifier utilizes a laminar airflow design. In another embodiment, the fluid amplifier is adapted to provide emergency mechanical ventilation. In another embodiment, the device is disposable. In another embodiment, the components are modular in design. In another embodiment, the device may be altered and / or adjusted by one or more geometries to achieve a desired set of parameters. According to another embodiment, the device can be modified by one or more of the following geometries to achieve a desired set of parameters: width of nozzle 102, depth of channel 108, radius of bias port attachment surface 103, shape of non-bias outlet, opening between bias channel 108 and non-bias channel 108, and aero offset 109 between the outlet of nozzle 102 and the start of the radius. In another embodiment, the desired set of parameters is determined by one or more of the following patient measurements: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and respiratory rate (RR).

[0040] Referring to Figure 1 herein, an example of a device that can be used as a ventilator or resuscitator is shown. In one embodiment, the device has a ventilator as shown in Figure 1 herein. In another embodiment, the device has a ventilator having one or more of the following components: fluid inlet 101, nozzle 102, bias-ported surface 103, non-bias-ported surface 104, exhaust 105, splitter 106, outlet 107, channel 108, and aero offset 109. In another embodiment, exhaust 105 is non-bias-ported. In another embodiment, splitter 106 provides a channel diverging geometry. In another embodiment, outlet 107 is a bias-ported port leading to the user's lungs.

[0041] In one embodiment, the device includes a fluid amplifier with one or more coaxially aligned components, where the one or more coaxially aligned components include one or more of the following: a fluid inlet 101, a nozzle 102, a bias port attached surface 103, a non-bias port attached surface 104, an exhaust 105, a splitter 106, an outlet 107, a channel 108, and an aero offset 109.

[0042] In another embodiment, the device has a fluid amplifier that can modularize one or more geometries to achieve a desired set of parameters. In another embodiment, the device has a fluid amplifier with one or more coaxially aligned components. In another embodiment, the device is one of a disjointed set of ventilator devices, where the devices in the set may be different sizes and / or labeled to identify which device best suits the patient's needs. In another embodiment, the patient's needs include measuring peak inspiratory pressure levels, positive end-expiratory pressure, and / or respiratory rate.

[0043] In one embodiment, the fluid amplifier includes a channel 108 having a channel depth to control the volume of gas moving through the device. In another embodiment, the channel depth affects the user's breathing rate. In another embodiment, the channel depth includes a teardrop-shaped channel to stabilize the incoming oxygen gas. In another embodiment, the channel depth includes an inspiratory phase channel and / or an expiratory phase channel. In another embodiment, the fluid amplifier includes a nozzle width to control the velocity of gas moving through the device. In another embodiment, the fluid amplifier ventilates the user through fluidics and pressure capacitance. In another embodiment, the fluid amplifier provides a breathing rate of 1-10 bpm. In another embodiment, the fluid amplifier provides a breathing rate of 1-80 bpm. In another embodiment, the fluid amplifier provides a breathing rate of 4-10 bpm, 7-20 bpm, and / or 20-40 bpm. In another embodiment, the fluid amplifier provides a breathing rate of 5-60 bpm. In another embodiment, the fluid amplifier provides a breathing rate of 10-40 bpm. In another embodiment, the fluid amplifier provides a respiratory rate of 15 to 35 bpm.

[0044] In another embodiment, the device has a fluid amplifier with one or more coaxially aligned components, which provides the device with the ability to reliably oscillate within a given pressure range, thereby enabling a robust design. In another embodiment, the reduced complexity of the device due to fluid oscillation allows the device to be incorporated into other designs and / or equipment. In another embodiment, the device can be used for emergency ventilation due to its ease of use based on the absence of internal moving parts, thereby increasing reliability and reducing errors in initial emergency treatment. In another embodiment, the device is relatively small and easy to transport, thus finding application in austere environments. In another embodiment, the one or more coaxially aligned components can reduce complexity and help ensure that device users are less likely to get confused or make errors when using the device in an intensive care environment. In another embodiment, the device is disposable. In another embodiment, the fluid amplifier is color-coded relative to the desired respiratory rate. In another embodiment, the fluid amplifier is shape-coded, e.g., circle, rectangle, and / or triangle. In another embodiment, the fluid amplifier is both shape- and color-coded.

[0045] In one embodiment, a method for treating a patient having an adverse condition includes providing a device having a fluid amplifier with one or more coaxially aligned components and ventilating the patient with the device. In another embodiment, the fluid amplifier is a ventilator. In another embodiment, the device includes one or more of the following operably connected components: fluid inlet 101, nozzle 102, bias port attached surface 103, non-bias port attached surface 104, exhaust 105, splitter 106, outlet 107, channel 108, and aero offset 109. In another embodiment, the adverse condition is a respiratory condition. In another embodiment, the adverse condition is an inflammatory condition. In another embodiment, the adverse condition is infection with coronavirus COVID-19. In another embodiment, the method for treating a patient having an adverse condition follows the protocol described in FIG. 2 herein. In another embodiment, the protocol is a ventilation and assessment process for a patient using one or more devices having a fluid amplifier with one or more coaxially aligned components.

[0046] In another embodiment, the device may be incorporated into a bag valve mask (BVM). In another embodiment, the device has jets to achieve the desired effect. In another embodiment, the device further has one or more surface finishes and / or coatings to achieve the desired effect.

[0047] The present invention further relates to kits for providing respiratory assistance. The kits are useful for carrying out the methods of the present invention for providing ventilation to a patient. The kits are an assemblage of materials or components including at least one of the compositions of the present invention. Thus, in some embodiments, the kits include compositions including one or more color-coded fluid amplifiers with variable dimensions and ventilation parameters, as described herein.

[0048] The exact nature of the components configured in the kits of the present invention will depend on their intended purpose. For example, some embodiments are configured for the treatment of respiratory distress associated with infection with the COVID-19 coronavirus. In one embodiment, the kit is configured specifically for the treatment of mammalian subjects. In another embodiment, the kit is configured specifically for the treatment of human subjects. In a further embodiment, the kit is configured for veterinary use, where the subjects to be treated include, but are not limited to, livestock, farm animals, and laboratory animals.

[0049] Instructions for use or a protocol may be included in the kit. The "instructions for use" or "protocol" typically include specific language describing techniques to be used using the components of the kit to achieve a desired result, e.g., to treat a patient with respiratory distress. Optionally, the kit also includes other useful components, such as a mask 118, a pressure relief valve 113, a pressure indicator 114, an anti-asphyxiation valve 115, a filter 116, tubing 117, diluents, buffers, pharmaceutically acceptable carriers, syringes, catheters, applicators, pipettes or measuring tools, bandages, or other useful equipment readily recognized by those skilled in the art. In another embodiment, the filter 116 is a heat and moisture exchange HEPA filter.

[0050] The assembled materials or components in the kit can be stored and provided to the practitioner in any convenient and appropriate manner that maintains their operability and usefulness. For example, the components can be provided at room temperature, refrigerated temperature, or frozen temperature. The components are typically contained in suitable packaging. As used herein, the term "packaging" refers to one or more physical structures used to contain the contents of the kit, such as the compositions of the present invention. The packaging is preferably constructed using well-known methods to provide a sterile, contaminant-free environment. The packaging used in the kit is typically packaging commonly used in treating patients with respiratory distress. As used herein, the term "package" refers to a suitable solid matrix or material, such as glass, plastic, paper, film, etc., capable of holding the individual kit components. The packaging typically has an exterior label indicating the contents and / or purpose of the kit and / or its components.

[0051] In one embodiment, the kit may include three fluid amplifiers (color-coded as red, yellow, and green). In another embodiment, the kit may include a protocol. According to the protocol, the care provider connects the appropriate fluid amplifier to the ventilator circuit. Various ventilation characteristics are achieved. In another embodiment, the kit may also include various accessories, such as oxygen tubing, a manometer, an anti-asphyxiation valve, and / or a heat and moisture exchange HEPA filter. In another embodiment, the kit may include a user interface for operating the device. In another embodiment, the kit may include a flow regulator for setting the flow. In another embodiment, the kit may include multiple fluid amplifiers for selection and installation / uninstallation as needed according to the protocol. In another embodiment, the kit may have only one fluid amplifier for selection and installation / uninstallation as needed according to the protocol.

[0052] Embodiments of the present disclosure are further described in the following examples, which are merely illustrative and are not intended to limit the scope of the invention as claimed in any way.

[0053] Example Example 1 advantage In one embodiment, the present technology relates to the field of fluid amplifiers and the use of this device across various technical fields. In another embodiment, the device provides a robust basic fluid amplifier that matches in-line with the connecting pipe / tubing of a system, capable of functioning without any internal moving components. In essence, this is a "coaxial fluid amplifier."

[0054] In another embodiment, the device may be for use as an in-line "coaxial" mechanical ventilator. Other embodiments may include, for example: 1. For use as mechanical actuators in industrial and robotic applications 2. For use in medical devices such as blood flow pumps 3. For use in gas flow monitoring devices 4. For use in power generation devices 5. For use in pressure relief and / or pressure maintenance devices

[0055] The various embodiments herein include several advantages.

[0056] 1. In one embodiment, the geometry of the device can be designed to be manufacturable for multiple manufacturing techniques, including machining, casting, additive manufacturing (3D printing), and injection molding.

[0057] 2. In another embodiment, the device is simple and robust enough to be manufactured and used as a disposable mechanical ventilator. In another embodiment, providing a disposable ventilator significantly reduces or eliminates the need for OEM-mandated equipment maintenance (a cost burden associated with traditional ventilators). In another embodiment, providing a disposable ventilator eliminates the need for sterilization to eliminate cross-contamination between patients and integrates well with the single-use environment already in place in most healthcare institutions. In another embodiment, providing a disposable ventilator can reduce or eliminate statutory ventilator certification requirements.

[0058] 3. In another embodiment, the device has a sufficiently robust design to function with minimal adjustments to reach minimum and maximum pressure thresholds during mechanical vibration.

[0059] 4. In another embodiment, the possibility of having an "in-line ventilator" that allows for modular inserts and / or separate sizes available to caregivers is a major enabler for ventilation technologies including, but not limited to, transport ventilation, emergency ventilation, and animal ventilation.

[0060] 5. According to another embodiment, its simplicity allows its size to be relatively small compared to conventional ventilation devices, which can provide improvements in the following areas: Improved logistics (making it easier to deliver this device to the point of use) b. Reduced manufacturing costs c. The relatively small size of the device is beneficial for transport ventilation (i.e., ease of transporting an individual connected to a ventilator and ease of continuing ventilation while the patient undergoes medical evaluation such as an MRI). d. The materials and simplicity of construction are conducive to use in an MRI environment.

[0061] The various embodiments herein may include several additional advantages.

[0062] 1. In one embodiment, the device has a design that allows adjustments to be made to the geometry to obtain a desired set of parameters. Such predictability of performance based on these geometries is beneficial. Some geometries may include: a.Nozzle width b. Channel height c. Bias port attachment surface radius d. Non-biased exit shape e. Opening between biased and non-biased channels f. Aero offset between nozzle exit and start of radius

[0063] 2. In another embodiment, the device may be amenable to additive manufacturing, allowing medical professionals to obtain the necessary patient data and manufacture a customized ventilator for that particular patient. Such additive manufacturing may occur at or near the point of use, enabling caregivers to utilize distributed manufacturing to rapidly manufacture custom medical devices.

[0064] 3. In another embodiment, the device is designed to vibrate reliably at extremely low differential pressures and flow rates.

[0065] 4. In one embodiment, the device has the potential for modular geometry. Thus, a respiratory professional can have a set of separate ventilator sizes labeled in several formats to help them identify the coaxial ventilator that best suits their patient's needs (based on desired PIP, PEEP, compliance, and RR at a given flow rate). This includes, for example: a.PIP: Maximum intake pressure b. PEEP: Positive end-expiratory pressure c.RR:Respiration rate

[0066] 5. In another embodiment, the coaxial "in-line" nature of the device includes improvements over conventional ventilation devices, eliminating dead space and reducing complexity.

[0067] 6. In another embodiment, features such as threads may be added to provide a means for controlling the restriction of flow through specific passageways to achieve desired minimum and maximum pressures (i.e., PIP and PEEP for mechanical ventilation) at a given flow rate.

[0068] 7. In one embodiment, dimensions can be manufactured in cartridge format that can be interchanged if necessary to achieve desired system characteristics.

[0069] Some additional advantages of the various embodiments herein include: 1. Predictable vibration – The ability of a device to vibrate reliably within a given pressure range allows users to create more robust designs. 2. Reduced Complexity - The reduced complexity that this device has for fluid vibration compared to prior art is a success factor for users to incorporate this economical device into their designs. 3. Ease of Use - For emergency use ventilation, the ease of use offered by this device, which has no internal moving parts, increases reliability and reduces the risk of error in initial emergency treatment. 4. The device is relatively small and easy to transport, which has applications in harsh environments. 5. The "coaxial" nature of the device can help reduce complexity and ensure that device users are less likely to get confused or make errors when using the device in an intensive care environment. 6. The device is made "disposable", which offers certain logistical and hygienic advantages.

[0070] Example 2 Table 1-Example of a fluid amplifier As further described herein, Figure 1 shows an example of a fluidic amplifier with the following components: fluid inlet 101, nozzle 102, bias ported surface 103, non-bias ported surface 104, exhaust 105, splitter 106, outlet 107, channel 108, and aero offset 109. In one embodiment, the device is a coaxial fluidic oscillator that functions as a mechanical ventilator. In connection with additional embodiments herein, Table 1 below lists components similarly referenced by numerals.

[0071] [Table 1-1] [Table 1-2]

[0072] Example 3 Examples of ventilation equipment As described herein, the inventors have developed various devices and associated methods and components for providing ventilation to a patient. In one embodiment, the ventilator is a constant-flow, pressure-cycled, single-use ventilator designed to provide emergency mechanical ventilation. The ventilator may include, for example, a simple fluid valve with an in-line manometer and a factory-preset peak inspiratory pressure (PIP) and a factory-preset positive end-expiratory pressure (PEEP) for the input gas flow indicated on the label. According to various embodiments herein, a pressure relief valve (POPOFF) for overpressure and an anti-asphyxiation valve (ASV) for preventing asphyxiation may be incorporated. The ventilator may be connected to the patient by one or more various components, including, for example, a face mask, a supraglottic airway, or an endotracheal tube. According to various embodiments herein, the ventilator may be a gas-powered, load-switched fluid valve device designed to provide pressure-cycled ventilation. Furthermore, the device can have the added advantage of having no moving parts, controls, or adjustments, and therefore, according to various embodiments herein, is set at the factory to provide the performance indicated on the product label.

[0073] In one embodiment, the ventilator device is a constant-flow, pressure-cycled, single-use ventilator designed to provide emergency mechanical ventilation, utilizing fluid characteristics within a fluid amplifier to oscillate between inspiratory and expiratory phases of ventilation. According to various embodiments herein, for example, three fluid amplifiers may be provided, modified as needed, based on applicable protocols. These fluid amplifiers may be referred to as, for example, "red, yellow, or green" amplifiers and may be designated within the protocols. In another embodiment, the ventilator device further includes a pressure indicator, including a visual indicator of a pressure range, or a manometer. In another embodiment, the ventilator device further includes a pressure relief valve, an anti-asphyxiation valve, a filter, and / or a gas tubing. In another embodiment, the inlet for oxygen, for example, delivered via oxygen tubing, is via a barbed fitting at the inlet of the fluid amplifier. In another embodiment, the ventilator device may be used in and in conjunction with, for example, hospitals, subacute facilities, disaster medicine, field medicine, and pre-hospital (EMS) environments and locations.

[0074] Example 4 Table 2 - Examples and specifications of ventilation equipment [Table 2-1] [Table 2-2]

[0075] In one embodiment, the device is intended for use by appropriately trained personnel to provide emergency, short-term, constant-flow, pressure-cycled ventilatory support to patients weighing 25 kg or more. In another embodiment, the device can be used in hospitals, subacute facilities, disaster medicine, field medicine, or pre-hospital (EMS) settings.

[0076] Example 5 Gas-powered resuscitator testing In accordance with ISO 10651-5 for gas-powered resuscitators, the inventors have conducted tests on various embodiments of the ventilator, fluid amplifier, and other related components and methods described further herein. These tests include: ·Vomiting resistance ·Water immersion Oxygen concentration Inhalation resistance Expiratory resistance PEEP test Pressure limiting ·Falling

[0077] The results of these tests showed that various embodiments of the ventilators, fluid amplifiers, and other related components and methods further described herein met the performance and design specification requirements and criteria outlined in ISO 10651-5—Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators.

[0078] Additionally, aging tests at approximately 60°C have been completed for various embodiments of the device. There is no significant change in performance after 14 days of storage at the high temperature range of approximately 60°C. According to ASTM F1980 using Q10=2.0, this indicates an acceptable calculated shelf life of 12 months.

[0079] For ventilation applications, materials can meet the requirements outlined in the ISO 18562 series. However, in terms of the actual fluidics itself, the device is not limited to the specific materials required. However, different materials may require different geometries to operate correctly due to differences in friction coefficients between air and various materials (which affect fluid mechanics or the Coanda effect).

[0080] Example 6 Table 3 -Red, yellow, and green coded fluid amplifiers As further described herein, various embodiments include a ventilator device that is a constant-flow, pressure-cycled, single-use ventilator designed to provide emergency mechanical ventilation. Designed to provide an economical ventilator that can be manufactured in large quantities and quickly in a relatively short time, this device may be an analog computer that utilizes gas flow (fluidics) to provide the pressure-cycling function and has no electronics or software. There is no direct power source utilized by the device. Instead, it relies on fluidics and pressure capacitance to ventilate the patient. Breath delivery characteristics, such as peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and inspiratory-expiratory ratio (IE), depend on the device's internal geometry and gas flow rate. Because this is a pressure-cycled ventilator, tidal volume (TV) and respiratory rate (RR) depend on lung compliance and resistance. Because there are no physical controls, breath delivery characteristics are specified at the factory during manufacture.

[0081] According to various embodiments herein, three fluid amplifiers may be provided that can be factory configured for respiratory delivery. In one embodiment, the three fluid amplifiers are configured for respiratory delivery at the following nominal values, as set forth in Table 3 below:

[0082] [Table 3]

[0083] Example 7 Flow characteristics during inspiration and expiration As an example, a fluid amplifier can be connected to a gas source by oxygen tubing. The tubing is press-fit onto the fluid amplifier hose barb and onto the DISS hose barb at the upstream flow control valve outlet. The gas flow rate is set by the care provider using the flow control valve upstream of the DISS barb fitting. Flow characteristics are also described in various figures herein.

[0084] Phase 1: Inhalation Oxygen enters the fluid amplifier through the amplifier's barbed fitting. The oxygen gas passes through a stabilizing "teardrop"-shaped channel and is then directed through a nozzle where its velocity accelerates. Due to the gas velocity, gas properties, and wall geometry at the nozzle exit, the gas jet adheres to the "patient" wall, favoring the inspiratory phase. The oxygen passes through the patient ISO fitting and is delivered to the patient circuit.

[0085] Due to the geometry and the high velocities internal to the device, a small percentage of the air is entrained through the exhaust port during the inspiratory phase. Patient physiology causes airway pressure to rise, thereby reducing flow to the patient. When the flow through the patient circuit reaches approximately the operating flow rate, the internal energy pressure balance is reversed and flow rapidly shifts to the exhaust port. At the moment of switching to the expiratory phase, a peak inspiratory pressure (PIP) is generated.

[0086] Phase 2: Exhalation The jet stream now redirects to the exhaust port, creating a weak suction force on the exhaust "stage" of the fluid amplification device. This suction force is one of the key factors in generating positive end-expiratory pressure (PEEP). The working jet stream now creates an active expiratory phase, with the jet drawing air from the patient's airway.

[0087] As with the inspiratory phase, when the energy pressure balance is reversed, the jet is rapidly redirected towards the patient to resume the inspiratory phase.

[0088] Example 8 Kit Components and Accessories In one embodiment, the kit may include three fluid amplifiers (color-coded as red, yellow, and green). In another embodiment, the kit may include a protocol. According to the protocol, the care provider connects the appropriate fluid amplifier to the ventilator circuit. Various ventilation characteristics are achieved. In another embodiment, the kit may also include various accessories, such as oxygen tubing, a manometer, an anti-asphyxiation valve, and / or a heat and moisture exchange HEPA filter. In another embodiment, the kit may include a user interface for operating the device. In another embodiment, the kit may include a flow regulator for setting the flow. In another embodiment, the kit may include multiple fluid amplifiers for selection and installation / uninstallation as needed according to the protocol.

[0089] Example 9 Additional research Leveraging findings from ventilated COVID-19-associated ARDS patients, the need for three ventilator modules was established. Level 1 (coded green) provided 16 cmH2O PIP and 6 cmH2O PEEP, Level 2 (coded yellow) provided 22 cmH2O PIP and 10 cmH2O PEEP, and Level 3 (coded red) provided 30 cmH2O PIP and 14 cmH2O PEEP, for mild, moderate, and restrictive lung disease, respectively. Using a lung simulator, three different pulmonary conditions were programmed and exposed to each module. V T , flow, pressure, and time were measured and summarized for each breath.

[0090] As a result, all three modules (red, yellow, and green) are designed for P within 1 cmH2O. AWThe goal was achieved. All models delivered PEEP levels within 2 cmH2O and minute ventilation within 1 L / min of the designed compliance level target. Results demonstrated reliable pressure-cycled ventilation. Predictable results were observed when exposed to lung conditions simulating COVID-19 ARDS. Using respiratory rate to determine pressure selection appears to be a viable option for tidal volume monitoring in disaster, EMS, or limited-resource settings.

[0091] Example 10 principle By utilizing a more predictable laminar flow range design for the fluid amplifier, we were able to eliminate all circuitry and simplify the design. For example, in one embodiment, the developed device is rugged, solid-state, has no moving parts, and is small enough to be placed in-line with the patient's endotracheal tube. In one embodiment, the device provides pneumatically driven pressure-cycled ventilation and is extremely compact (2.2 x 6.3 cm) and lightweight. The ventilator is modular and consists of a fluid amplifier valve, a standard medical ISO gas source barb connector, and a standard patient mask / airway adapter (15 mm / 22 mm). The device can assist or control the patient's ventilation. In one embodiment, the device can be customized to target either a PIP of 10-35 cmH2O, a PEEP of 5-20 cmH2O, an I:E ratio of 1:1-1:3, and a RR of 5-60 bpm for patients with small or large lungs, either healthy or diseased. A fluid amplifier connected to a compressed air / oxygen source providing a continuous flow of 25 L / min via simple low-pressure oxygen tubing provides the pressure cycling function.

[0092] In one embodiment, the base of the device comprises a 3D-printed device with a fluid amplifier channel. Medical breathing gas is supplied to the fluid amplifier through a barbed port. As gas flows through the power nozzle of the fluid amplifier, the resulting jet attaches to the right wall and enters the patient's lungs, increasing pressure. Furthermore, little entrainment enters the device during inspiration. The geometry is designed so that once pressure is reached, the feedback flow is large enough to switch the power jet from right to left, ending the inspiration portion of the respiratory cycle. The pressure at which this switch occurs depends on the geometry setting of the right channel. The inspiration time depends on how quickly the lungs fill to the set pressure. The faster the time to reach inspiratory pressure, the more elastic the lungs are.

[0093] When the jet is switched to the left wall, gas from the right channel (of the patient) flows until the pressure reaches the set PEEP level. PEEP is set by the geometry of the left channel. The lower the flow rate from the patient's lungs, the faster the PEEP level is reached. Once the set PEEP is reached, the feedback flow is large enough to switch the device back to inspiration.

[0094] Total respiratory system compliance (CRS) affects respiratory rate, with low respiratory system compliance resulting in an increased respiratory rate. Based on a set pressure, a generated known I:E ratio (e.g., in one embodiment, T1 coded green and yellow is estimated at 33%, and red is estimated at 36%), and a fixed inspiratory flow rate, estimates of tidal volume and compliance can be determined from RR.

[0095] Example 11 Geometry Development Fluidics is the process of processing information through a fluid medium and transmitted output. Thus, for example, a device may be conceptualized as a pre-programmed black box that presents outputs (PEEP, PIP, RR, TV) once the geometric characteristics (or features in machine learning terminology) of the device are fixed within the device. Channel Depth - controls the volume of gas moving through the fluid amplifier, affecting the respiration rate (RR). Nozzle Width - Controls gas velocity, which affects output pressure, especially PEEP. Also, one objective was to develop predictive models for programming devices to perform within the desired characteristics of each coded "color" of the family.

[0096] Example 12 Simulation Models and Statistical Analysis We used a basic supervised regression ML algorithm. To solve this problem, we ask the learning algorithm to output a function.

[0097]

number

[0098] To generate training data, over 300 devices were 3D printed and bench-tested. Each device had slight variations in its characteristics (e.g., all were fixed, but the channel depth varied by 0.25 mm for each device). Using this data, a predictive model could be generated that found values ​​for parameters that satisfied the required characteristics (e.g., PIP, PEEP, I:E ratio) over several iterations. 3D printing a large number of devices using an inexpensive printer allowed for the generation of a large training dataset in a short period of time. Completion took an average of 3 hours per device per data point.

[0099] To evaluate the ventilator and determine its performance capabilities, switching pressures (PIP and PEEP), respiratory rate, and tidal volume (V T ) and minute ventilation (V E ) can be chosen to focus on. These various parameters can be used, for example, to estimate COVID-19 pulmonary symptoms. Using an ASL 5000 (IngMar Medical, Pittsburgh, PA) lung simulator with the RespiSim System, three different pulmonary symptoms (mild, moderate, and severe) were programmed, with each model given 50 breaths (a total of at least 150 breaths per device) before moving on to the next pulmonary symptom setting. This simulates ARDS with various respiratory mechanics during controlled ventilation. C RS The volume was varied from 25 to 50 mL / cmH2O and the resistance was varied from 5 to 15 cmH2O / L / sec to mimic various restrictive lung diseases.

[0100] The manikin was orally intubated with an 8.0 endotracheal tube and the cuff inflated to 25 mmHg. To mimic current COVID-19 recommendations, an in-line 14 French suction catheter and HMEF were placed in-line. Tidal volume, flow, pressure, and time were measured at 256 Hz. Each breath was summarized by model and pulmonary status.

[0101] Statistical analysis was performed using pressure switch settings, model-predicted minute ventilation, and target ARDS severity. Pressure and flow recordings were analyzed using JMP Pro 14 (SAS Institute, Inc.). Volume thresholds for breath initiation and exhalation initiation were set at 5 mL. Flow tracings were used to measure peak inspiratory flow, respiratory rate, and T I , T E , I:E ratio, and V T The peak P was calculated from the pressure waveform. AW , PEEP and driving pressure were determined. Performance characteristics considered undesirable and significant were: Pressure (P) above target by + / - 2cmH2O AWand PEEP) P AW >30cm H2O PEEP>20cmH2O Driving pressure >15cmH2O Inhalation time <0.6 seconds Target minute ventilation + / - 1L / min RR<8 and >35

[0102] Example 13 Additional research findings Pressure Switch : 2250 breaths were analyzed. Looking at the color-coded fluid amplifier, green delivered 831 breaths, yellow delivered 751 breaths, and red delivered 668 breaths without difficulty. The average P for all breaths was AW The mean PEEP levels for all breaths were 16.3 cmH2O (±0.46), 22.4 cmH2O (±0.71), and 28.3 cmH2O (±0.81) for green, yellow, and red, respectively. The mean PEEP levels for all breaths were 7.0 cmH2O (±0.62), 10.9 cmH2O (±0.73), and 15.7 cmH2O (±0.76) for green, yellow, and red, respectively. The mean driving pressures for all breaths were 9.3 (±0.79), 11.6 (±0.50), and 12.6 (±1.02) for green, yellow, and red, respectively. All models achieved the target PEEP within 1 cmH2O. AW All models achieve the desired PEEP level and driving pressure within 2 cmH2O. Color-coded fluid amplifiers, green and yellow, achieve their set PEEP level within 1 cmH2O.

[0103] breathing rate : The mean respiratory rate (RR) with devices designed for pulmonary disease was 17 bpm (± 1.7), 20 bpm (± 1.1), and 28 bpm (± 3.1) for the green, yellow, and red color-coded fluid amplifiers, respectively. In severe pulmonary disease models, green, yellow, and red RRs greater than 26 indicate a switch to a higher-pressure device or referral. In normal lung conditions, red RRs less than 14 suggest a change to lower pressures for both men and women due to high tidal volumes. Yellow RRs less than 16 indicate a change to lower InVent pressures for women due to tidal volumes greater than 8 mL / Kg.

[0104] volume : Mean V with devices designed for pulmonary disease TE The V was 430 mL (±39.1), 393 mL (±27.1), and 284 mL (±47.8) for the green, yellow, and red color-coded fluid amplifiers, respectively. In severe lung disease, green indicated no tidal volume greater than 220 mL, while in mild lung disease, red indicated tidal volumes greater than 570 mL. V occurred in all simulated lung diseases. E is the target V E The target V of 8.3 L / min was not reached, but was below 1 L / min. E was closest to.

[0105] protocol : By assessing performance during the three pulmonary symptoms, the RR and safe V T This could be used as an indicator of when to change the color of the fluid amplifier to create a range. Starting in yellow allows for a quick assessment of lung compliance with the generated RR. From data and evaluation of commonly accepted tidal volumes of 4-8 mL / Kg for an average male (71 kg) and an average female (55 kg) PBW, it was found that a RR of 16-26 for females and 14-23 for males would be acceptable to stay in yellow, and the estimated V TThis would be understood to be 220-440 mL for women and 280-570 mL for men. If RR exceeds the target range, the pressure can be considered to be rising to the red level of 28 / 14 (DP=14) as the tidal volume approaches 4 mL / Kg or less for that gender. If RR is below the target range, V T If the RR approaches 8 mL / Kg or more for any gender, the pressure should be reduced to the green level of 16 / 6 (DP=10). Additionally, for the average US citizen, if the RR is above or below the target, the patient should be given a low V T and there is a real risk of hypoventilation, or V T There is a real risk of significant trauma. Adding other non-invasive monitors, such as ECG, RR, ETCO2, and SpO2, to gain a more comprehensive understanding of ventilation and oxygenation, may also be helpful, if available.

[0106] Example 14 Low, medium, and high range According to various embodiments herein, fluid amplifiers and related devices and methods can be referred to and provided as low intensity, medium intensity (or moderate), or high intensity. The following are example ranges, as referenced by PIP, PEEP, and driving pressure readings: PIP Low=PIP 16~18cmH2O Medium=PIP 22~24cmH2O High=PIP 28~30cmH2O PEEP Low=PEEP 6~8cmH2O Medium=PEEP10~12cmH2O High=PEEP14~16cmH2O Driving Pressure Low=8~10 Medium=11~13 High=14~16

[0107] Various embodiments of the present invention have been described above in the detailed description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive of improvements and / or variations to the specific embodiments shown and described herein. Any such improvements or variations that fall within the scope of this specification are intended to be included herein as well. Unless otherwise specified, it is the inventor's intention that the words and phrases in the specification and claims be understood in their ordinary and accustomed meanings by those skilled in the art.

[0108] The foregoing description of various embodiments of the present invention known to applicant at the time of filing this application has been presented and is intended for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, as many modifications and variations are possible in light of the above teachings. The described embodiments serve to illustrate the principles of the present invention and its practical application, and to enable those skilled in the art to utilize the invention in various embodiments, with various modifications as suited to the particular use intended. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out the invention.

[0109] While specific embodiments of the present invention have been shown and described, it will be apparent to those skilled in the art that, based on the teachings herein, changes and modifications can be made without departing from the present invention and its broader aspects, and therefore, the appended claims are intended to encompass within their scope all such changes and modifications that fall within the true spirit and scope of the present invention. Furthermore, the present invention should be understood to be defined solely by the appended claims. Those skilled in the art will generally understand that the terms used in this specification, and particularly in the appended claims (e.g., the subject matter of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "including" should be interpreted as "including, but not limited to," etc.). Furthermore, those skilled in the art will understand that, where a specific numbered recitation of the introduced claims is intended, such intention will be expressly recited in the claims, and, absent such recitation, no such intention exists. For example, to aid in understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce claim matter. However, the use of such phrases should not be construed as meaning that introducing claim matter with the indefinite article "a" or "an" limits any particular claim containing such introduced claim matter to an invention containing only one (e.g., "a" and / or "an" should ordinarily be construed to mean "at least one" or "one or more"). The same applies to the use of definite articles used to introduce claim matter, even if the same claim also includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an."Furthermore, even when specific numbers of introduced claim items are explicitly recited, a person skilled in the art will recognize that such items should typically be understood to mean at least the recited numbers (e.g., simply saying "recited in two" without any other modifier typically means recited in at least two or recited in more than two).

[0110] Accordingly, the invention is not limited except as by the appended claims.

Claims

1. A device, A device having a fluidic amplifier with multiple coaxially aligned components.

2. The device of claim 1 , wherein the fluid amplifier has a channel depth for controlling the pressure and / or volume of gas moving through the device.

3. The device of claim 2 , wherein the channel depth affects a user's breathing rate.

4. The device of claim 2 , wherein the channel depth comprises a teardrop-shaped channel for stabilizing incoming oxygen gas.

5. The device of claim 2 , wherein the channel depth comprises an inspiratory phase channel and / or an expiratory phase channel.

6. The device of claim 1 , wherein the fluid amplifier has a nozzle width for controlling the velocity of gas moving through the device.

7. The device of claim 1 , wherein the fluid amplifier provides ventilation to the user through fluidics and pressure capacitance.

8. The device of claim 1 , wherein the fluid amplifier provides a respiratory rate of 2 to 200 bpm.

9. The device of claim 1 , wherein the fluid amplifier provides a respiratory rate of 10 to 40 bpm.

10. The device of claim 1 , wherein the fluid amplifier provides a respiratory rate of 15 to 35 bpm.

11. The device of claim 1 , wherein the fluid amplifier is color coded relative to a desired pressure.

12. 10. The device of claim 1, wherein the fluid amplifier utilizes internal geometry and gas flow to provide a desired peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and inspiratory-expiratory ratio (IE) to a user.

13. The device of claim 1 , wherein the fluid amplifier is connected to a gas source.

14. 14. The device of claim 13, wherein the fluid amplifier is connected to the gas source by an oxygen tube.

15. 15. The device of claim 14, wherein the fluid amplifier has a barbed and / or threaded connector that connects to the oxygen tubing.

16. 10. The device of claim 1, wherein the coaxially aligned components include a fluid inlet, a nozzle, a bias port attached surface, a non-bias port attached surface, an exhaust, a splitter, an outlet, a channel depth, and / or an aero offset.

17. The device of claim 1 , wherein the fluid amplifier utilizes a laminar airflow design.

18. The device of claim 1 , wherein the fluid amplifier is adapted to provide emergency mechanical ventilation.

19. 10. The device of claim 1, wherein the device is part of an overall treatment regimen for infection with coronavirus COVID-19.

20. The device of claim 1 , wherein the device is disposable.

21. The device of claim 1 , wherein the coaxially aligned components are of modular design.

22. The device of claim 1 , wherein the device can be modified and / or adjusted by one or more geometries to obtain a desired set of parameters.

23. 10. The device of claim 1, wherein the device can be modified by one or more of the following geometries to obtain a desired set of parameters: nozzle width, channel depth, radius of bias port attachment surface, shape of non-bias outlet, opening between bias and non-bias channels, and aero offset between nozzle outlet and start of radius.

24. 10. The device of claim 1, wherein the device is one of a separate set that may be different sizes and / or labeled to identify which device best suits the patient's needs.

25. 25. The device of claim 24, wherein the patient needs include measuring the level of peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and / or respiratory rate (RR).

26. The device of claim 1 , wherein the fluid amplifier is integrated into a flow generating device.

27. The device of claim 1 , wherein the fluid amplifier is connected to and / or incorporated into a bag valve mask (BVM).

28. The fluid amplifier is 5 to 50 cmH ２ 10. The device of claim 1, wherein the device provides a PIP of 0.

29. The fluid amplifier is 2 to 30 cmH ２ 10. The device of claim 1, wherein the device provides a PEEP of O.

30. The device of claim 1 , wherein the fluid amplifier utilizes a turbulent flow design.

31. A kit comprising: A kit comprising a device having a fluid amplifier adapted for ventilation of a subject.

32. 32. The kit of claim 31, wherein the fluid amplifier comprises one or more components that are coaxially aligned.

33. 32. The kit of claim 31, wherein the fluid amplifier has a fluid inlet and an outlet.

34. 32. The kit of claim 31, wherein a breathable gas is provided to the fluid inlet.

35. 32. The kit of claim 31, wherein the fluid inlet comprises a barbed fitting.

36. 32. The kit of claim 31, wherein the fluid amplifier is connected to a gas source by oxygen tubing.

37. 37. The kit of claim 36, wherein the flow rate of the gas source can be controlled by an upstream flow control valve.

38. 32. The kit of claim 31, wherein the fluid amplifier has a channel depth for controlling the volume and / or pressure of gas moving through the device.

39. 39. The kit of claim 38, wherein the channel depth comprises a teardrop-shaped channel for stabilizing incoming oxygen gas.

40. 39. The kit of claim 38, wherein the channel depth comprises an inspiratory phase channel and / or an expiratory phase channel.

41. 32. The kit of claim 31, wherein the fluid amplifier has a nozzle width for controlling the velocity of gas moving through the device.

42. 32. The kit of claim 31, wherein the fluid amplifier provides ventilation to the user through mechanisms of fluidics and pressure capacitance.

43. 32. The kit of claim 31, wherein the fluid amplifier provides a respiratory rate (RR) of 5 to 500 bpm.

44. 32. The kit of claim 31, comprising a low pressure fluid amplifier, a medium pressure fluid amplifier, and / or a high pressure fluid amplifier.

45. 32. The kit of claim 31, comprising a fluid amplifier having a RR of 10 to 19 bpm, a fluid amplifier having a RR of 20 to 27 bpm, and / or a fluid amplifier having a RR of 28 to 50 bpm.

46. 32. The kit of claim 31, comprising one or more color-coded fluid amplifiers as part of an overall protocol for treating severe pulmonary disease in a patient.

47. 32. The kit of claim 31, wherein the device is operably connected to the subject for the inspiratory and expiratory phases of ventilation.

48. 32. The kit of claim 31, further comprising a pressure relief valve (PRV), a pressure indicator, an anti-asphyxiation valve, a filter, and / or an oxygen tube.

49. 32. The kit of claim 31, further comprising an ASV, a manometer, and / or a pressure limiter.

50. 32. The kit of claim 31, comprising a low pressure fluid amplifier, a medium pressure fluid amplifier, and a high pressure fluid amplifier.

51. 32. The kit of claim 31, wherein the device provides pressure-cycled mechanical ventilation.

52. 1. A method of treating a patient having an adverse condition, comprising: providing a ventilation device having a fluid amplifier with one or more coaxially aligned components; and Treating the patient with ventilation. A method comprising:

53. 53. The method of claim 52, wherein the fluid amplifier has one or more of the following operably connected components: a fluid inlet, a nozzle, a bias port attached surface, a non-bias port attached surface, an exhaust, a splitter, an outlet, a channel depth, and an aero offset.

54. 53. The method of claim 52, wherein the adverse condition is respiratory-related.

55. 53. The method of claim 52, wherein the adverse condition is infection with coronavirus COVID-19.

56. 53. The method of claim 52, wherein the ventilation device comprises one or more color-coded fluid amplifiers having different pressure intensities.

57. 53. The method of claim 52, wherein the therapy is part of an overall protocol having a green-coded fluid amplifier with a respiratory rate (RR) intensity of 15-18 bpm, a yellow-coded fluid amplifier with a RR intensity of 19-26 bpm, and / or a red-coded fluid amplifier with a RR intensity of 27-30 bpm.

58. 53. The method of claim 52, wherein the fluid amplifier has one or more internal channels.

59. 60. The method of claim 58, wherein the one or more internal channels are visible to a user when viewed from outside the device.

60. 53. The method of claim 52, wherein the ventilation device is stored in digital form so that it can be mass-produced on demand when needed.

61. 53. The method of claim 52, wherein the ventilation device is transmitted and stored in digital form to allow custom manufacturing for use in specific patients and / or patient populations.

62. 53. The method of claim 52, wherein the ventilation device is printed at or near the point of use for the treatment of a particular patient and / or patient population.

63. 53. The method of claim 52, wherein the fluid amplifier is of monostable design.

64. 53. The method of claim 52, wherein the fluid amplifier is of a bistable design.

65. 53. The method of claim 52, wherein the adverse condition is sleep apnea.

66. 53. The method of claim 52, wherein the fluid amplifier provides continuous positive airway pressure (CPAP).

67. The fluid amplifier is 9 cmH ２ O maximum inspiratory pressure (PIP), 7 cmH ２ Positive end-expiratory pressure (PEEP) of 0, and / or 8 cmH ２ 53. The method of claim 52, wherein CPAP is provided at O.

68. 53. The method of claim 52, wherein the fluid amplifier provides pressure-cycled mechanical ventilation.

69. 53. The method of claim 52, wherein the treatment is for a mammal.

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