CN116635100A

CN116635100A - Fluid mixing device, such as a respirator

Info

Publication number: CN116635100A
Application number: CN202180058412.9A
Authority: CN
Inventors: 杰弗瑞·特拉维斯·道尔顿; 乔丹·弗朗西斯·克利福德; 特拉维斯·安德鲁·迪安
Original assignee: Reggie Usa Inc
Current assignee: Reggie Usa Inc
Priority date: 2020-05-29
Filing date: 2021-05-18
Publication date: 2023-08-22
Also published as: JP2023526137A; CA3180779A1; MX2022015010A; WO2021242557A1; TW202206134A; IL298640A; TWI814002B

Abstract

An apparatus, such as a fluid mixer, suitable for use with a ventilator, comprises: a venturi nozzle for flow of a pressure controlled fluid; a surrounding fluid aperture in fluid communication with the venturi nozzle; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable relative to the venturi nozzle between a start flow position and a stop flow position; wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve relative to the venturi nozzle; and wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve relative to the venturi nozzle. A method of using the device suitable for a respirator is also disclosed.

Description

Fluid mixing device, such as a respirator

Technical Field

The present invention relates generally to a fluid mixing apparatus, and more particularly, to a fluid mixing apparatus such as may be used in respirators for human patients suffering from respiratory symptoms of a disorder such as covd-19 or chronic respiratory disorders, and methods of using such respirators.

Background

By the date of the present application, a covd-19 virus pandemic has been traversing the world. Covd-19 contains many symptoms, but is primarily a respiratory disease. Most people exposed to the covd-19 virus have mild symptoms (if present) and quickly recover from full health. However, few people respond extremely severely to exposure to the covd-19 virus. With these people, their lungs become infected and inflamed, filling the alveoli with pus or fluid, and become occluded to interfere with oxygen transfer to the capillaries. The worst case patient to the covd-19 virus will suffer from Acute Respiratory Distress Syndrome (ARDS). The lungs of patients with ARDS are severely damaged by the covd-19 virus and their alveoli become fluid filled. Naturally occurring surfactants in the lungs that help alveoli distend and shrink are destroyed to make the lungs stiffer. In addition, inflammation from ARDS increases the gap between the alveolar interior surface and adjacent microvessels to further reduce oxygen transfer to the microvessels. Patients suffering from such extreme symptoms from a covd-19 infection or other etiology must be intubated and connected to a ventilator to push oxygen into their lungs and improve oxygen transfer to the blood.

As many cannulas as possible and ventilation may be the last line of defense between life and death for patients suffering from severe symptoms of a covd-19 infection and other patients with ARDS, ventilation is traumatic and expensive; another step between completely unassisted breathing and complete cannula ventilation would be beneficial. In addition, current ventilators can discharge droplets exhaled by a patient into the patient's surroundings (typically a hospital ward or intensive care unit). These droplets often carry the covd-19 virus from the infected patient and present a risk to health care workers and other patients.

Furthermore, current respirators rely on a continuous supply of compressed oxygen to function properly; operation of such current respirators requires a continuous flow of oxygen supply. This continuous flow wastes oxygen and adds cost and makes current respirators unsuitable for remote locations, locations in low-grade developing countries, or other locations where a large and continuous supply of oxygen cannot be used or has little opportunity to be used. Similarly, existing respirators rely on electronics to control the respirator and on power to power the electronics. This need for electricity also makes current respirators unsuitable for remote locations, locations in low-development countries, or other locations where sustained electricity cannot be used or where there is little opportunity to use sustained electricity.

Thus, there is a need for improved respirators that are less invasive for the patient and that expose people in the vicinity of the ventilated patient to less risk of infection.

Furthermore, unfairness in health care is very prominent worldwide, especially in medium and low income countries (LMICs) such as india. Traditional ventilation methods are expensive and create an economic burden of billions of cents annually in the united states alone. In LMICs, the use of respiratory care devices such as respirators is limited not only because of these high costs, but also because of the lack of resources such as power transformation. Traditional ventilation methods have limited ability to provide therapy to various respiratory systems of people worldwide because they are very delicate and require extensive infrastructure to operate, including the need for clean space, power supplies, and normal maintenance and servicing to maintain optimal performance conditions.

In addition, conventional ventilation systems are expected to monitor both the clinical performance of the device and the patient system interaction of the device. Monitoring patients for compliance with their doctor's instructions regarding the use of respiratory therapy devices has been a breach. Verifying compliance is an important step in having the medical device company receive reimbursement, and if not verified at all, the company cannot reimburse the cost of supplying its equipment.

There is a need for new methods of venting devices in the medical field that at least partially address the deficiencies associated with conventional venting devices. In particular, it would be desirable to provide a ventilation device capable of providing therapy to patients in LMICs lacking infrastructure and power loss and a device that can monitor patient compliance, which is critical to the medical device company's receipt of their reimbursement for patient supply devices.

Disclosure of Invention

According to some embodiments, a ventilator may be mechanical that relies on the patient's natural breathing to control the flow of air into the ventilator. The provided gas flow is at a pressure slightly above ambient pressure and may also be enriched with oxygen to assist patients with dyspnea. According to some embodiments, rather than relying on electronics to control air flow, a simple and robust mechanical valve is used to shut off the flow of compressed air and/or oxygen into the venturi (inlet). The valve is actuated by small pressure changes that occur when the patient breathes naturally. The valve may be based on a simple diaphragm, a flapper valve system, a bistable diaphragm system, or a spring-loaded shuttle system.

According to an aspect of the present invention, there is provided a respirator comprising: a venturi nozzle for flow of a pressure controlled fluid; a surrounding fluid aperture in fluid communication with the venturi nozzle; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable relative to the venturi nozzle between a start flow position and a stop flow position; wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve relative to the venturi nozzle; and wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve relative to the venturi nozzle.

According to an aspect of the present invention there is provided a ventilator connectable to the airways of a living patient, comprising: a venturi tube comprising a throat; a venturi nozzle; a venturi opening in the venturi nozzle through which pressure controlled oxygen flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding air aperture in fluid communication with the venturi nozzle and surrounding air; a fluid port in fluid communication with the airway of the patient; a pressure multiplier in fluid communication with the fluid port, wherein the pressure multiplier includes at least one opening defined therethrough; the pressure multiplier includes at least one flap movable relative to the at least one opening between an open position and a closed position; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes the flow of pressure controlled oxygen to entrain the ambient air into the throat and a stop flow position that stops the flow of pressure controlled oxygen from entraining the ambient air into the throat; wherein the pressure multiplier is configured to cause the patient to exhale into the fluid port to actuate the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle; wherein the pressure multiplier is configured such that inhalation by the patient through the fluid port actuates the valve along the axis of movement relative to the venturi nozzle; and wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat.

According to an aspect of the present invention there is provided a ventilator connectable to the airways of a living patient, comprising: a venturi tube comprising a throat; a venturi nozzle; a venturi opening in the venturi nozzle through which pressure controlled oxygen flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding air aperture in fluid communication with the venturi nozzle and surrounding air; a fluid port in fluid communication with the airway of the patient; a pressure multiplier in fluid communication with the fluid port, wherein the pressure multiplier includes at least one opening defined therethrough; the pressure multiplier includes at least one flap movable relative to the at least one opening between an open position and a closed position; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes the flow of pressure controlled oxygen to entrain the ambient air into the throat and a stop flow position that stops the flow of pressure controlled oxygen from entraining the ambient air into the throat; wherein the pressure multiplier is configured to cause the patient to exhale into the fluid port to actuate the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle; wherein the pressure multiplier is configured such that inhalation by the patient through the fluid port actuates the valve along the axis of movement relative to the venturi nozzle; wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat; and includes at least one of a sensor, a measuring device, and a power generation device positioned between at least one of: the venturi nozzle and the ambient air aperture; and the pressure multiplier and the fluid port; and wherein at least one of the sensor, measuring device and generating device comprises at least one of: pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, piezoelectric generator, spirometer measuring device, pitot measuring probe, and spirometer generator.

At least one of the sensor, measuring device, and generating device may be positioned between the venturi nozzle and the ambient air aperture, and at least one of the sensor, measuring device, and generating device may be positioned between the pressure multiplier and the fluid port.

To collect differential data, at least one of the sensor, measurement device, and power generation device may be positioned between the venturi nozzle and the ambient air aperture, and at least one of the same type of sensor, measurement device, and power generation device may be positioned between the pressure multiplier and the fluid port.

The ventilator may include a central processing unit for packaging raw data collected by at least one of the sensor, measurement device, and power generation device.

The respirator may include a motion sensor.

The ventilator may include an exhalation window for allowing fluid to exit the ventilator during exhalation and a fluid flow restrictor for at least selectively partially closing the exhalation window to set Positive End Expiratory Pressure (PEEP) for the patient. The fluid flow restrictor allows the ventilator to restrict the amount of air exiting the ventilator during a setup period to thereby extend expiration periods and thereby allow the patient's PEEP to be modified to a safe level to avoid, for example, lung atrophy. In addition, catheterized patients often require further procedures, such as CT scanning, which requires the patient to be transferred from the respiratory device to another respiratory device. This process of mechanically transporting ventilated patients can create various problems for the health of the patient. Wherein a brief period of patient disconnect from ventilation results in loss of Positive End Expiratory Pressure (PEEP) and reduced residual capacity (FRC). A significant reduction in FRC in patients with severe acute respiratory distress syndrome may cause a deterioration of hypoxia. In some cases, it takes several hours to increase FRC and eliminate hypoxia. The present invention at least partially solves this problem found in conventional transportation ventilation methods by eliminating PEEP reduction when switching the patient from an emergency care ventilator to a transportation ventilator and back again, resulting in significantly improved patient care.

According to another aspect, the invention contemplates an apparatus adapted for use with a ventilator, comprising: a venturi; comprising a throat, a venturi nozzle, and a venturi opening in the venturi nozzle through which a pressure-controlled fluid flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding fluid aperture in fluid communication with the venturi nozzle and surrounding fluid; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid and a stop flow position that stops entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid; wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle; wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve along the axis of movement relative to the venturi nozzle; wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat; wherein the pressure multiplier is positioned between the venturi nozzle and the fluid port; and includes at least one of a sensor, a measuring device, and a power generation device positioned between at least one of: the venturi nozzle and the surrounding fluid aperture; and the pressure multiplier and the fluid port; and wherein at least one of the sensor, measuring device and generating device comprises at least one of: pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, piezoelectric generator, spirometer measuring device, pitot measuring probe, and spirometer generator.

The apparatus may include a central processing unit for packaging raw data collected by at least one of the sensor, measurement device, and power generation device.

The apparatus may include a motion sensor.

The apparatus may include at least one fluid gate for allowing fluid to leave the apparatus when fluid is forced into the fluid port and a fluid flow restrictor for at least selectively partially closing the at least one fluid gate.

The apparatus may further comprise a pressure regulator for regulating the flow of the pressure controlled fluid, the pressure regulator comprising: a housing formed to include an inner bore therein; a piston movably disposed within the bore, wherein the piston includes an annular lip adjacent a first end thereof; a spring disposed within the bore and including a first end and a second end; an adjustment cap movably disposed in the bore, wherein the adjustment cap is formed to include a plurality of keyways formed therein; wherein: the first end of the spring is in physical contact with the annular lip; and the second end of the spring is in physical contact with the adjustment cap, wherein: rotating the adjustment cap in a first direction causes the adjustment cap to compress the first spring; rotating the adjustment cap in a second and opposite direction causes the adjustment cap to decompress the spring; rotating the adjustment cap in the first direction increases the output pressure of the pressure regulator; rotating the adjustment cap in the second direction reduces the output pressure of the pressure regulator; the bore is defined by a cylindrical wall; the cylindrical wall is formed to include a first thread therein; the adjustment cap is formed to include a second thread formed on a periphery thereof; and the second thread is configured to engage with the first thread.

The pressure multiplier may include a diaphragm.

The valve may include a stem having a tapered end, wherein the tapered end enters the venturi opening in the venturi nozzle in the stopped position to substantially close the venturi opening.

The apparatus may further comprise at least one filter detachably connected to the surrounding fluid aperture.

The pressure-controlled fluid may be a liquid.

In another aspect, the invention includes a method of collecting data from a patient using a device suitable for a ventilator, the method comprising: providing a pressure controlled oxygen source; providing an apparatus suitable for a respirator, the apparatus comprising: a venturi comprising a throat, a venturi nozzle, and a venturi opening in the venturi nozzle through which pressure controlled oxygen flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding fluid aperture in fluid communication with the venturi nozzle and surrounding air; a fluid port; a pressure multiplier in fluid communication with the fluid port, wherein the pressure multiplier includes at least one opening defined therethrough; the pressure multiplier includes at least one flap movable relative to the at least one opening between an open position and a closed position; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes the flow of pressure controlled oxygen to entrain the ambient air into the throat and a stop flow position that stops the flow of pressure controlled oxygen from entraining the ambient air into the throat; placing the fluid port in fluid communication with the airway of the patient; causing the at least one flap to move to the closed position relative to the at least one opening and actuate the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle in response to exhalation of the patient through the fluid port; and causing the at least one flap to move to the open position relative to the at least one opening and actuate the valve along the axis of movement relative to the venturi nozzle in response to inhalation by the patient through the fluid port; and wherein the axis of movement of the valve is substantially longitudinally aligned with the longitudinal direction of the throat; and includes at least one of a sensor, a measuring device, and a power generation device positioned between at least one of: the venturi nozzle and the ambient air aperture; and the pressure multiplier and the fluid port; and wherein at least one of the sensor, measuring device and generating device comprises at least one of: pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, piezoelectric generator, spirometer measuring device, pitot measuring probe and spirometer generator; and collecting raw data using the at least one of the sensor, the measuring device, and the power generation device; encapsulating the collected raw data using a central processing unit; transmitting the encapsulated raw data to a receiving device using a wired or wireless communication link; receiving the encapsulated data on the receiving device; unsealing the collected raw data; quantifying the unsealed raw data; formatting the quantized data; analyzing the formatted data; distributing the analyzed data; and displaying the analyzed data using an application.

The method may include the step of coupling the central processing unit to the respirator.

Using the wireless communication link may include using at least one wireless protocol selected from Bluetooth, wi-Fi, and Thread.

Using the wired communication link may include using at least one of USB, serial, single-wire, and parallel.

The method may include displaying the analyzed data using an intelligent device.

The smart device may include at least one of a mobile communication device, a tablet computer, a patient interface display, a laptop computer, and a desktop computer.

According to another aspect, the present invention contemplates an active filter comprising at least one piezoelectric element and at least one dielectric filter medium, wherein the piezoelectric element generates electricity to induce electrostatic charge in the dielectric filter medium.

The use of piezoelectricity in this device will be used to power the sensors disclosed herein for data collection and data transmission. By placing a phototransistor between the metal walls in the device, an electrical charge is created as mechanical pressure driven by the patient's breath is applied to the metal. This pressure essentially generates electricity by unbalance the crystals. This may generate up to 2mW of power (similar to the power stored in a lithium battery) to generate enough power for the device sensors to collect and transmit data. For example, the limiter 72 and/or the rib 74 shown in fig. 2A may be or be covered by a piezoelectric element that is capable of generating electricity as a result of actuating the respirator and, in particular, as a result of the flange 38 striking the limiter 72 (which continuously vibrates the rib 74 after striking).

The power generated by the at least one piezoelectric element may be AC.

The active filter may include at least one spirometer that generates electricity to induce an electrostatic charge in the at least one dielectric filter media.

The active filter may include two spirometers that generate electricity to induce an electrostatic charge in the at least one dielectric filter medium.

The power generated by the at least one spirometer may be DC.

The inhalation by the patient through the fluid port may actuate the valve relative to the venturi nozzle to open the venturi nozzle.

Expiration of the patient into the fluid port may cause the at least one flap to move to the closed position relative to the at least one opening in the pressure multiplier.

The inhalation by the patient through the fluid port may cause the at least one flap to move to the open position relative to the at least one opening in the pressure multiplier.

According to another aspect, the invention contemplates an apparatus for a respirator comprising: a venturi nozzle for flow of a pressure controlled fluid; a surrounding fluid aperture in fluid communication with the venturi nozzle; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable relative to the venturi nozzle between a start flow position and a stop flow position; wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve relative to the venturi nozzle; and wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve relative to the venturi nozzle.

According to another aspect, the invention contemplates an apparatus adapted for use with a ventilator, comprising: a venturi comprising a throat, a venturi nozzle, and a venturi opening in the venturi nozzle through which a pressure-controlled fluid flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding fluid aperture in fluid communication with the venturi nozzle and surrounding fluid; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid and a stop flow position that stops entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid; wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle; wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve along the axis of movement relative to the venturi nozzle; wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat; and wherein the pressure multiplier is positioned between the venturi nozzle and the fluid port. Thus, the present invention does not rely on the continuous flow of the pressure-controlled fluid, which is common in known constructions. Thus, significant savings in both economy and environment can be realized due to the present invention actuating the valve to regulate the flow of the pressure controlled fluid, which in effect makes the overall process more efficient. The apparatus may be particularly suited for remote locations, locations in low-level development countries, or other locations where a large and continuous supply of oxygen is unavailable or has little opportunity to be used.

The pressure multiplier may be configured such that the (any) fluid forced into the fluid port actuates the valve to a stopped flow position relative to the venturi nozzle; and the pressure multiplier may be configured such that the fluid(s) withdrawn from the fluid port actuate the valve to a start flow position relative to the venturi nozzle.

The pressure multiplier may be configured such that the (any) fluid forced into the fluid port actuates the valve to a start flow position relative to the venturi nozzle; and the pressure multiplier may be configured such that the fluid(s) withdrawn from the fluid port actuate the valve to a stopped flow position relative to the venturi nozzle. This may be considered, for example, to be the opposite configuration.

The pressure multiplier may be configured such that the (any) fluid forced into the fluid port actuates the valve to an active flow position between the start flow position and the stop flow position relative to the venturi nozzle; and the pressure multiplier may be configured such that the fluid (any) withdrawn from the fluid port actuates the valve to an active flow position between the start flow position and the stop flow position relative to the venturi nozzle. In this configuration, the action of both fluid forced into the fluid port and fluid withdrawn from the fluid port may actuate the valve to an active flow position. This may be considered a point anywhere between the stop flow position and the start flow position. Thus, flow from the stopped flow position to the starting flow position and all positions between the stopped flow position and the starting flow position may be fully controlled and/or regulated.

The apparatus may be defined such that the pressure controlled fluid comprises oxygen, the surrounding fluid comprises ambient air, the fluid forced into the fluid port comprises air exhaled into the air port, and the fluid withdrawn from the fluid port comprises air inhaled from the air port.

The pressure multiplier may be positioned between the venturi nozzle and the fluid port. This positioning may provide enhanced actuation of the valve.

The venturi nozzle may be positioned between the pressure multiplier and the fluid port. The inventors believe that this positioning may also provide enhanced actuation of the valve.

The venturi nozzle may be positioned between the surrounding fluid aperture and the fluid port. The inventors have found that this positioning may also provide enhanced actuation of the valve.

The apparatus may include a pressure regulator for regulating the flow of the pressure controlled fluid. It should be appreciated that at least one of a number of different pressure regulators suitable for regulating the flow of the pressure controlled fluid may be included.

More particularly, the apparatus may include a pressure regulator (for regulating the flow of the pressure controlled fluid) comprising: a housing formed to include an inner bore therein; a piston movably disposed within the bore, wherein the piston includes an annular lip adjacent a first end thereof; a spring disposed within the bore and including a first end and a second end; an adjustment cap movably disposed in the bore, wherein the adjustment cap is formed to include a plurality of keyways formed therein; wherein: the first end of the spring is in physical contact with the annular lip; and the second end of the spring is in physical contact with the adjustment cap, wherein: rotating the adjustment cap in a first direction causes the adjustment cap to compress the first spring; rotating the adjustment cap in a second and opposite direction causes the adjustment cap to decompress the spring; rotating the adjustment cap in the first direction increases the output pressure of the pressure regulator; rotating the adjustment cap in the second direction reduces the output pressure of the pressure regulator; the bore is defined by a cylindrical wall; the cylindrical wall is formed to include a first thread therein; the adjustment cap is formed to include a second thread formed on a periphery thereof; and the second thread is configured to engage with the first thread. This regulator may be particularly effective in regulating the flow of the pressure-controlled fluid. The inventors have found that this pressure regulator has a particularly good synergy with the apparatus defined herein. This synergy allows this pressure regulator to be specifically selected to produce enhanced performance of the device.

The pressure multiplier may include a diaphragm. The diaphragm may be dished to enhance its function.

The pressure multiplier may be bistable. This may be in an inhalation configuration and an exhalation configuration. In this way, the pressure multiplier exhibits two steady states, which are particularly beneficial in at least some embodiments of the invention.

The pressure multiplier may be biased toward the stopped flow position. In some embodiments, the pressure multiplier may be preferably biased toward the stopped flow position, and this configuration makes this possible.

The pressure multiplier may be biased toward the start flow position. Conversely or additionally, in some embodiments, the pressure multiplier may be preferably biased toward the start flow position and this configuration makes this possible.

The pressure multiplier may include at least one cover plate.

The apparatus may be entirely mechanical. According to some embodiments, the apparatus is fully mechanical providing the benefit of ease of manufacture and operation.

The apparatus may be configured such that in the start flow position or active flow position, a mixture of pressure controlled fluid and ambient fluid is allowed to flow to the fluid port. For example, the ambient fluid (e.g., ambient air) may become entrained by the flow of the pressure-controlled fluid (e.g., oxygen) to drive flow and move toward the fluid ports.

The flow of the mixture may be modulated in real time. Thus, the apparatus may control, alter and/or regulate the flow of the fluid mixture in an alternative manner to, or in addition to, regulating only the flow of the pressure controlled fluid.

The valve may include a flange connected to the pressure multiplier.

The valve may include a stem having a tapered end, wherein the tapered end enters a venturi opening in the venturi nozzle in the stopped position to substantially close the venturi opening. This configuration may operate the valve particularly effectively with respect to the features of the apparatus defined herein.

The lever may be connected to the pressure multiplier. This configuration may make the rod and pressure multiplier stronger during operation.

The valve may comprise a switch. This may be particularly effective when binary systems or binary states are desired.

The valve may comprise a flapper valve.

The valve may comprise a spring loaded shuttle system.

The valve is slidable.

The valve may be entirely mechanical.

The surrounding fluid aperture may include a fluid vent. Thus, the surrounding fluid aperture may have the dual function of allowing fluid to enter and exit. Draining fluid from the apparatus may reduce contamination by the used fluid within the apparatus and may simplify the apparatus by eliminating the need to store the used fluid that is not drained.

The valve may be configured to actuate relative to the venturi nozzle while opening the fluid discharge port. This dual function may increase the operating efficiency of the apparatus.

The apparatus may further comprise at least one filter detachably connected to the surrounding fluid aperture. The filter is operable to filter fluid flowing into/out of the device. The use of a single filter to filter both the incoming and outgoing fluids may increase the operating efficiency of the apparatus.

The at least one filter may comprise pores of about 3 μm. For example, this aperture is particularly effective in removing contaminants such as viruses and bacteria from fluids such as air.

The apparatus may further comprise a ventilator or similar apparatus that provides fluid communication between the ventilator and the airway of the patient. The inventors have found that the ventilator used in conjunction with or forming part of the device is particularly effective in treating respiratory conditions such as covd-19.

The ventilator may be in fluid communication with the fluid port. For example, the fluid port may be directly or indirectly connected to the ventilator.

The fluid described hereinabove may be a liquid. In various applications, liquid may pass through the device. It will be appreciated that the device may also be used to administer liquids such as drugs. For example, the device may thus act as an improved nebulizer or vaporizer useful for administering a medicament in the form of a liquid mist that may be inhaled into the lungs by a patient suffering from a respiratory disease or condition. However, it should be appreciated that the apparatus may be used to utilize any suitable liquid.

The apparatus may be injection molded. Thus, the apparatus can be quickly reproduced in a cost-effective manner.

The apparatus may be manufactured by additive manufacturing (e.g., a 3D printing process). Thus, the apparatus can be reproduced accurately and in a cost-effective manner, which makes the apparatus particularly attractive in low-level development countries.

The apparatus may be configured to be mobile.

The apparatus may be configured to be reusable. Because the apparatus can be cleaned effectively, it can be adapted for reuse. This is particularly beneficial in low-level development countries where the availability of new devices is not readily available.

The apparatus described herein may be used to control the flow of air and/or oxygen into a ventilator.

The apparatus described herein may be used to control the flow of purified air and/or oxygen into a ventilator.

The devices described herein may be used to treat respiratory conditions.

The devices described herein may be used to treat covd-19.

In another aspect, the invention contemplates a method of using an apparatus suitable for a respirator, the method comprising: providing a pressure controlled fluid source; an apparatus suitable for a ventilator is provided comprising: a venturi nozzle for receiving a flow of the pressure controlled fluid; a surrounding fluid aperture in fluid communication with the venturi nozzle; a fluid port; a pressure multiplier in fluid communication with the fluid port; and a valve movable relative to the venturi nozzle between a start flow position and a stop flow position in which the pressure-controlled fluid mixes with the ambient fluid; actuating the valve relative to the venturi nozzle in response to fluid being forced into the fluid port; and actuating the valve relative to the venturi nozzle in response to fluid withdrawal from the fluid port.

In another aspect, the invention contemplates a method of using an apparatus suitable for a respirator, the method comprising: providing a pressure controlled oxygen source; providing an apparatus suitable for a respirator, comprising: a venturi tube comprising a throat; a venturi nozzle; a venturi opening in the venturi nozzle through which pressure controlled oxygen flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned; a surrounding air aperture in fluid communication with the venturi nozzle and surrounding air; a fluid port; a pressure multiplier in fluid communication with the fluid port, wherein the pressure multiplier includes at least one opening defined therethrough; the pressure multiplier includes at least one flap movable relative to the at least one opening between an open position and a closed position; and a valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes the flow of pressure controlled oxygen to entrain the ambient air into the throat and a stop flow position that stops the flow of pressure controlled oxygen from entraining the ambient air into the throat; placing the fluid port in fluid communication with the airway of the patient; causing the at least one flap to move to the closed position relative to the at least one opening and actuate the valve along an axis of movement relative to the venturi nozzle to close the venturi nozzle in response to exhalation of the patient through the fluid port; and causing the at least one flap to move to the open position relative to the at least one opening and actuate the valve along the axis of movement relative to the venturi nozzle in response to inhalation by the patient through the fluid port; and wherein the axis of movement of the valve is substantially longitudinally aligned with the longitudinal direction of the throat.

The apparatus in this method may be entirely mechanical.

At least a portion of the valve is movable within the throat along the axis of movement.

The method may further comprise adjusting the pressure of the pressure controlled fluid.

The method may include the pressure controlled fluid being pressure controlled oxygen, and wherein the fluid is air, the method including: connecting the device to a ventilator or similar device (respirator); placing the ventilator in gaseous communication with the patient and the pressure controlled oxygen source; initiating flow of oxygen into the ventilator in response to inhalation by the patient, mixing the oxygen with ambient air to produce and deliver high oxygen air to the patient; stopping flow of oxygen into the ventilator and exhausting exhaled air from the ventilator in response to the patient exhaling.

The high oxygen air may have a FiO of at least 26% ₂ 。

The method may include the pressure-controlled fluid being pressure-controlled filtered air, and wherein the fluid is air, the method including: connecting the device to a ventilator or similar device; placing the ventilator in gaseous communication with the patient and the pressure-controlled filtered air source; initiating flow of oxygen into the ventilator in response to inhalation by the patient, mixing the pressure-controlled filtered air with ambient air to produce purified air and delivering the purified air to the patient; stopping flow of oxygen into the ventilator and exhausting exhaled air from the ventilator in response to the patient exhaling.

The purified air may have at least 26% FiO ₂ 。

The method may further include walking and/or running while utilizing the apparatus and a ventilator or similar apparatus. For example, this may involve using the apparatus while the user is in motion.

The method may further comprise eliciting the use of the apparatus, ventilator or similar apparatus to treat allergy.

The method may further comprise eliciting use of the apparatus, ventilator or similar apparatus to treat ARDS.

The method may further comprise eliciting use of the apparatus, ventilator or similar apparatus to treat sleep apnea.

The method may further comprise eliciting use of the apparatus, ventilator or similar apparatus to treat COPD.

The method may further comprise eliciting use of the device, ventilator or similar device to treat a covd-19 virus infection.

The method may further include filtering the ambient air.

The method may further include filtering exhaled gas from the patient.

In another aspect, the invention encompasses a pressure multiplier comprising a sealed end and an open end, wherein the sealed end is in fluid communication with a valve to define a fixed volume between the sealed end and the valve, wherein the pressure multiplier is configured such that a pressure change of the open end causes a pressure change of the sealed end to actuate the valve. Such a pressure multiplier may be particularly effective for use with the apparatus defined herein. However, this pressure multiplier is considered to have itself the inventive rights.

The pressure multiplier may be configured such that negative pressure at the open end causes pressure at the sealed end to decrease to actuate the valve.

The pressure multiplier may be configured such that positive pressure of the open end causes pressure of the sealed end to increase to actuate the valve.

The actuation of the valve may activate the humidifier.

The actuation of the valve may produce a change in visual pointer. The visual pointer may be, for example, a color change.

The visual pointer change may be indicative of a pressure change at the open end.

The pressure change at the open end may be caused by inhalation and/or exhalation by the patient. Thus, the pressure multiplier is suitable for many different applications, which makes the pressure multiplier a particularly useful fitting in many different fields of operation.

The nature and utility of the invention described in this summary and the following detailed description are not all-inclusive. Many additional features and advantages will be apparent to one of ordinary skill in the art in view of the following description. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated.

Drawings

FIG. 1 is a perspective cut-away view of a respirator in an inhalation configuration.

FIG. 2 is a side cross-sectional view of the respirator of FIG. 1 in an inhalation configuration.

FIG. 2A is a detailed perspective cut-away view of the respirator of FIG. 1 in an inhalation configuration, showing the diaphragm in the inhalation configuration.

Fig. 3 is a perspective cutaway view of the respirator in an exhalation configuration.

Fig. 3A is a detailed perspective cut-away view of the respirator of fig. 3 in an exhalation configuration, showing the exhalation window.

Fig. 3B is a detailed perspective cut-away view of the respirator of fig. 3 in an exhalation configuration, showing a cover flap.

Fig. 4 is a side cross-sectional view of the respirator of fig. 3 in an exhalation configuration.

FIG. 5 is a perspective cut-away view of another embodiment of a respirator.

Fig. 6 is a side cross-sectional view of the respirator of fig. 5.

FIG. 7 is a detailed perspective cut-away view of the valve of the respirator of FIG. 5.

FIG. 8 is a detailed side cross-sectional view of the valve of the respirator of FIG. 5.

Fig. 9 is a perspective view of an embodiment of a secondary regulator 500.

Fig. 10 is a cross-sectional view of a secondary regulator 500.

Fig. 11 is a cross-sectional view of another embodiment of a secondary regulator 700.

Fig. 12 is an exploded view of the secondary regulator 700.

Fig. 13 is a top view of adjustment cap 750 disposed within secondary regulator 700.

Fig. 14 is a perspective view of the adjustment cap 750.

FIG. 15 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a sensor in one position.

FIG. 16 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a sensor in another position.

FIG. 17 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having sensors in multiple positions.

Figure 18 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention with a spirometer in one position.

Figure 19 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention with a spirometer in another position.

Figure 20 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a spirometer in multiple positions.

Fig. 21 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a pitot tube.

Figure 22 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a piezoelectric element.

Figure 23 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having sensors, spirometers, pitot tubes, and piezoelectric elements in multiple positions.

Fig. 24 is a perspective cut-away view of the respirator/device of fig. 23.

Fig. 25 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having an active filter.

Fig. 26 is a perspective cut-away view of the respirator/device of fig. 25.

Fig. 27 is a flow chart of a method according to an embodiment of the invention.

FIG. 28 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention without a fluid flow restrictor.

Fig. 29 is a perspective cut-away view of the respirator/device of fig. 28.

FIG. 30 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a fluid flow restrictor in an open position.

Fig. 31 is a perspective cut-away view of the respirator/device of fig. 30.

FIG. 32 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a fluid flow restrictor in a restricted position.

Fig. 33 is a perspective cut-away view of the respirator/device of fig. 30.

The use of the same reference symbols in different drawings indicates similar or identical items.

Detailed Description

Referring to fig. 1-2, an embodiment of a fluid mixer 2 is shown. The fluid mixer 2 may also be referred to as a fluid mixing device 2 or device 2. The fluid mixer 2 may be used in a variety of applications. For example, the fluid mixer 2 may be used in medical applications, automotive applications, racing applications, and other applications. As seen in fig. 1 to 2, the fluid mixer 2 is a respirator 2. The term "ventilator" as used in the present invention encompasses any and all medical applications in which ventilator 2 may be used, such as, but not limited to, continuous Positive Airway Pressure (CPAP) machines and bi-level positive airway pressure (BiPAP) machines.

Returning to 1-2, an exemplary ventilator 2 is shown in an inhalation configuration wherein a patient is inhaling gas through ventilator 2. The respirator 2 is advantageously entirely mechanical. As used in this disclosure, the term "fully mechanical" is defined to mean a mechanism that can operate based on gas pressure changes controlled by the patient's breath without electrical or electronic means. According to other embodiments, the respirator 2 uses electrical and/or electronic devices, in whole or in part, to control, power, or otherwise operate. The respirator 2 includes a surrounding fluid aperture 4, which may be generally bell-shaped or which may have any other suitable shape. The opening of the surrounding fluid aperture 4 may have any suitable shape, such as, but not limited to, circular, elliptical, rectilinear or polygonal, and may be side-to-side and/or radially symmetric or asymmetric. The ambient fluid aperture 4 may be located at the end of the respirator 2. The respirator 2 also includes a fluid inlet 6 positioned proximate to the surrounding fluid aperture 4. The fluid inlet 6 may be connected to a source of a pressure controlled fluid, such as oxygen. As seen in fig. 1, the surrounding fluid apertures 4 and the fluid inlets 6 may be arranged substantially perpendicular to each other; however, the surrounding fluid aperture 4 and the fluid inlet 6 may be arranged relative to each other in any other suitable manner. The fluid inlet 6 may include threads 8 defined on its outer diameter to facilitate oxygen or other pressure controlled fluid connection to the ventilator 2. The pressure entering the fluid inlet 6 is advantageously slightly higher than the surrounding atmosphere. The pressure at the fluid inlet 6 may be adjusted as will be described in more detail below. When used to treat a patient, the fluid inlet 6 may be an oxygen inlet through which oxygen enters the ventilator 2.

Air from the surrounding fluid aperture 4 and oxygen from the fluid inlet 6 are mixed in the venturi 10. According to some embodiments, a channel 12 is defined in the respirator 2 radially outward of the surrounding fluid aperture 4, and oxygen from the fluid inlet 6 travels from the fluid inlet 6 through the channel 12 to the venturi nozzle 14 and out the venturi opening 16 in the venturi nozzle 14. The particular path, cross section and other details of the channel 12 are not critical to the invention; in particular, the passages 12 may be configured in any manner so long as a sufficient amount of oxygen is delivered to the venturi opening 16. The air passage 18 allows air to flow from the surrounding fluid aperture 4 to the venturi nozzle 14. As the oxygen leaves the venturi opening 16 of the venturi nozzle 14, the oxygen stream entrains and mixes with air from the throat 19 of the venturi 10, which is enriched in oxygen compared to the ambient air. Above the venturi nozzle 14, a central passage 17 extends upwardly to allow oxygen-enriched air to travel to the patient during inhalation and to allow exhaled air to travel outwardly from the patient during exhalation. As is generally understood in the art, a venturi is typically a short tubular section having a centrally located tapered constriction (throat 19) that causes an increase in the flow velocity of fluid therethrough. As can be seen from fig. 1-2, the venturi opening 16 in the venturi nozzle 14 through which pressure-controlled oxygen (or other pressure-controlled fluid, for example) flows outwardly opens into the throat 19, and wherein the venturi opening 16 and the throat 19 are substantially longitudinally aligned.

Valve 20 is positioned above venturi nozzle 14. As used herein, directional terms such as "top," "bottom," "above," "below," and the like, refer to the orientation and relative position of a component shown in the figures with respect to a page for ease of description; the respirator 2 may be used in any orientation, and such orientation terms are not limiting on the use of the respirator 2. According to some embodiments, the valve 20 includes a stem 22, which may include a tapered end 24. The tapered end 24 may be tapered such that a portion of the tapered end 24 has a diameter that is less than the diameter of the venturi opening 16 and may enter the venturi nozzle 14 through the venturi opening 16. In the open inhalation position shown in fig. 1, the tapered end 24 is spaced from the venturi opening 16 so that oxygen can flow out of the venturi opening 16 and entrain ambient air from the air passage 18 into the throat 19 of the venturi 10. According to other embodiments, the stem 22 need not include a tapered end 24, but may instead include an end whose diameter widens nearer the venturi nozzle 14, such that the wider end is capable of blocking the venturi opening 16 in a closed position without substantially entering the venturi opening 16. The rod seat 21 may extend laterally toward the rod 22 and may include a rod aperture 23 configured to receive and guide the rod 22 in its longitudinal movement while substantially limiting lateral movement of the rod 22. The stem aperture 23 may have a shape similar to and slightly larger than the stem 22. For example, if the rod 22 is substantially cylindrical, the outer diameter of the rod 22 may be slightly smaller than the diameter of the rod aperture 23 such that the rod aperture 23 allows the rod 22 to slide relative to the rod aperture 23 while the rod aperture 23 also limits lateral movement of the rod 22. The valve 20 may never float as seen in fig. 1-2. The valve 20 may optionally be biased toward the inhalation configuration shown in fig. 1-2, for example, by a spring (not shown) or other structure or mechanism. Alternatively, the valve 20 may be biased toward the exhalation configuration, for example, by a spring (not shown) or other structure or mechanism.

The stem 22 extends from a tapered end 24 to a vent ring 26. The vent ring 26 may be generally cylindrical in shape, including a generally circular bottom 28 and a curved body 30. One or more windows 32 may be defined by the curved body 30. The vent ring 26 may be received by an aperture 34 in a vent ring seal 36. The aperture 34 may have a shape similar to and slightly larger than the vent ring 26. For example, if the vent ring 26 is substantially cylindrical, the outer diameter of the vent ring 26 may be slightly smaller than the diameter of the aperture 34 such that the aperture 34 of the vent ring seal 36 allows the vent ring 26 to slide relative to the aperture 34 while the aperture 34 also limits lateral movement of the vent ring 26. At least one flange 38 may extend radially outward from the vent ring 26. The flange 38 may extend outwardly from the upper edge of the vent ring 26 or any other suitable portion of the vent ring 26.

Flange 38 may be connected to a pressure multiplier 40 within a chamber 42; the flange 38 is advantageously fixed to a pressure multiplier 40. According to some embodiments, the pressure multiplier 40 is a diaphragm 40. The diaphragm 40 extends radially between the vent ring 26 and an inner surface 44 of the chamber 42. The membrane 40 is flexible and durable and may be made of any suitable material such as rubber, latex, plastic, or other material or materials. Because flange 38 is connected to diaphragm 40, downward movement of diaphragm 40 causes flange 38, and thus the entire valve 20, to move downward; upward movement of the diaphragm 40 causes the flange 38 and thus the entire valve 20 to move upward. According to some embodiments, the diaphragm 40 may be biased toward its position in the inhalation configuration. According to other embodiments, the membrane 40 may be bistable such that it is stable in both its position in the inhalation configuration and its position in the exhalation configuration. In this embodiment, the valve 20 is movable along a movement axis relative to the venturi opening 16 in the venturi nozzle 14 between a start flow position that causes entrainment of ambient fluid into the throat 19 by the flow of pressure controlled fluid (e.g., pressure controlled oxygen) and a stop flow position that stops entrainment of ambient fluid into the throat 19 by the flow of pressure controlled fluid. For example, in an embodiment of the present invention, the pressure multiplier 40 is configured such that fluid forced into the fluid port 54 actuates the valve 20 along the axis of movement relative to the venturi nozzle 14 to close the venturi nozzle 14; additionally, in an embodiment of the present invention, the pressure multiplier 40 is configured such that fluid withdrawn from the fluid port 54 actuates the valve 20 along the axis of movement relative to the venturi nozzle 14. In this embodiment, the axis of movement of the valve 20 is substantially longitudinally aligned with the longitudinal direction of the throat 19. In this embodiment, at least a portion of the valve 20 is movable along the axis of movement within the throat 19.

Referring also to fig. 2A, in the inhalation configuration, the inlet channel 41 is in fluid communication with the central channel 17. The vent ring 26 is located in an upward position relative to the venturi nozzle 14. Thus, the bottom 27 of the vent ring 26 may be substantially planar with the lower surface 37 of the vent ring seat 36, and the inlet aperture 43 is thus open to place the central passage 17 in fluid communication with the inlet passage 41. The flange 38 may be configured as a grid or grating (e.g., concentric grid as shown in fig. 2A) such that the plurality of flange openings 39 allow fluid to flow therethrough. In the inhalation configuration, both sides of the diaphragm 40 are thus in fluid communication with each other via the flange opening 39; the flange opening 39 places the inlet channel 41 and the fluid port 54 in fluid communication in the inhalation configuration. Thus, in the inhalation configuration, the central passage 17, inlet passage 41, and fluid port 54 are in fluid communication with one another such that the high oxygen air is free to flow from the venturi nozzle 14 to the fluid port 54, and then to the patient.

If the membrane 40 is bistable, the membrane 40 may be in one of its two bistable configurations in the inhalation configuration seen in FIG. 2A. The use of a bi-stable diaphragm 40 having a stable configuration in the inhalation configuration means that after reaching the inhalation configuration, the patient does not need to use any inhalation force to maintain the inhalation configuration; thus, the ventilator 2 may be used to treat patients with degraded respiratory ability. If the diaphragm 40 is stable in a single configuration, the configuration may be the inhalation configuration shown in FIG. 2A.

A pressure multiplier 40 is in fluid communication with the fluid port 54, wherein the pressure multiplier 40 includes at least one opening 39 defined therethrough; the pressure multiplier 40 includes at least one flap 70 movable relative to the at least one opening 39 between an open position and a closed position. Referring also to fig. 3B, one or more flaps 70 may be associated with the flange 38. The flap 70 will be described in more detail below with respect to fig. 3B. In the inhalation configuration, fluid flow towards the fluid port 54 causes the flap 70 to scrape upwardly away from the flange 38 and its (flange) opening 39 allows free flow of high oxygen air to the patient through the (flange) opening 39. In this embodiment, the pressure multiplier 40 is positioned between the venturi nozzle 14 and the fluid port 54.

Restrictor 72 may optionally be positioned in chamber 42 above flange 38. According to some embodiments, the limiter 72 may be a ring having a diameter substantially the same as the vent ring 26, wherein the limiter 72 is substantially coaxial with the vent ring 26. The limiter 72 may be connected to, secured to, or integral with one or more ribs 74 extending therefrom. One or more ribs 74 may extend upwardly from the limiter 72; alternatively, one or more ribs 74 may extend laterally or downwardly from the limiter 72. The rib 74 may be substantially rigid such that it does not experience substantially bending or flexing during normal use of the respirator 2. According to other embodiments, one or more of the ribs 74 may be flexible. Each rib 74 is connected at one end to the restrictor 72 and at the other end to a portion of the chamber 40. For example, one or more ribs 74 are connected to an upper wall 76 of the chamber 40. The ribs 74 may be secured to the upper wall 76 of the chamber 40 or integral with the upper wall 76 of the chamber 40. For example, the upper wall 76 of the chamber 40, the ribs 74, and the restraints 72 may be injection molded, manufactured by additive manufacturing, or manufactured in any other manner as a single integral piece. The limiter 72 prevents the vent ring 26 and thus the valve 20 from moving upward from the vent ring seat 36 and/or stem seat 21.

According to some embodiments, the limiter 72 has another shape than a ring. For example, the limiter 72 may be in the shape of a bar, rod, X, square, rectangle, oval, or any other suitable shape. Restrictor 72 may have any shape and be placed in any position relative to vent ring 26 to engage vent ring 26 in the inhalation configuration to restrict its upward travel to prevent valve 20 and/or vent ring 26 from becoming unseated and to allow substantially unrestricted fluid flow out of flange opening 39.

At the upper end of the chamber 42, a fluid port 54 allows inhaled air to flow out of the respirator 2 and exhaled air to flow into the respirator 2. At least one filter 56 may be positioned adjacent to the fluid port 54 to filter both inhaled and exhaled air. The filter 56 is advantageously a 3 micron filter or other filter suitable for removing viruses, pollen and other airborne contaminants from the air. In this way, the filter 56 protects the patient from ambient contaminants and also protects other people around the ventilator 2 from infecting the air exhaled from the patient. The filter 56 is detachably connected to the respirator 2 such that the filter 56 is periodically replaceable. The filter 56 may be a single use filter or may be cleaned and sterilized so that it may be reused after cleaning and sterilization. Alternatively, the filter 56 may be placed adjacent to the surrounding fluid aperture 4 or at another location on the respirator 2. For example, according to some embodiments, a filter 56 is positioned adjacent to the surrounding fluid aperture 4 to filter both inhaled and exhaled air. In this way, the filter 56 protects the patient from ambient contaminants and also protects other people around the ventilator 2 from infecting the air exhaled from the patient. Alternatively, more than one filter 56 may be utilized.

The chamber 42 may be connected via a fluid port 54 to a ventilator (not shown) worn by the patient. As commonly used in the industry, the term "ventilator" refers to a device that provides breathable air to a patient or other user, for example, by providing a supply of breathable gas. However, as used in this disclosure, the term "ventilator" is specifically defined to exclude any requirement that the ventilator itself filter anything from the air provided to or exhaled by the patient. According to some embodiments, the ventilator is substantially impermeable to fluids, whether gases or liquids. According to some embodiments, the ventilator may be a mask having a flexible sealing surface or other seal or seals such that a substantially airtight seal is created against the patient's face. According to some embodiments, the ventilator may be a helmet or other structure that engages a portion of the patient other than the face; for example, the ventilator may be a helmet that substantially seals the neck of the patient and does not contact the face. According to some embodiments, all or part of the ventilator may be positioned within the nose and/or mouth of the patient, and the ventilator is substantially sealed from the nose and/or mouth. According to some embodiments (e.g., the embodiments described above), the ventilator is substantially sealed from the patient's airway. By substantially sealing the ventilator against the patient's airway, small pressure changes as the patient breathes cause valve 20 to move, as will be described in more detail below. In this way, the ventilator, and thus the patient, is in fluid communication with the ventilator 2. Because the ventilator is substantially impermeable to gases, substantially all of the patient's exhaled gases reach the fluid port 54 of the ventilator 2, such that only a small exhalation effort causes the valve 20 to move. Alternatively, the ventilator and patient may be in fluid communication with the ventilator 2 in any other suitable manner.

Referring to fig. 3-4, the ventilator 2 is shown in an exhalation configuration in which the patient is exhaling gas through the ventilator 2. As will be described in more detail below, the exhalation pressure from the patient deflects the center of the diaphragm 40 downward. Thus, the flange 38 connected to the diaphragm 40 moves downward. Downward movement of the flange 38 may be limited by the vent ring seat 36, and an upper surface of the vent ring seat 36 may engage a lower surface of the flange 38 to thereby prevent further downward movement of the flange 38. In the exhalation configuration, the valve 20 has moved downwardly relative to the venturi nozzle 14 and the tapered end 24 of the stem 22 substantially blocks the venturi opening 16. In this manner, oxygen is substantially prevented from flowing outwardly from the fluid inlet 6 through the venturi opening 16. The length of the stem 22 is advantageously manufactured such that the tapered end 24 or other lower end of the stem 22 substantially blocks the venturi opening 16 when the flange 38 engages the vent ring seat 36.

Referring also to fig. 3A, in the exhalation configuration, the inlet channel 41 is no longer in substantial fluid communication with the central channel 17. The vent ring 26 is located in a downward position relative to the venturi nozzle 14. Thus, the bottom 27 of the vent ring 26 is positioned below the lower surface 37 of the vent ring seat 36, and the inlet aperture 43 is thus closed such that the central passage 17 substantially ends in fluid communication with the inlet passage 41. An O-ring or other seal (not shown) may extend radially outward from the vent ring seat 36 to facilitate closing the inlet aperture 43 in the exhalation configuration. Alternatively, the inlet aperture 43 need not be fully or partially closed in the exhalation configuration, as the exhaled air will still travel outwardly through the central passage 17, as will be described below.

In the exhalation configuration, the flange 38 has moved downwardly relative to its position in the inhalation configuration and may be in contact with the vent ring seat 36. In this manner, the vent ring seat 36 may be used to limit downward movement of the vent ring 26. Alternatively, contact between the tapered end 24 of the stem 22 and the venturi nozzle 14 limits downward movement of the vent ring 26. When the flange 38 is in the exhalation configuration and the flange 38 contacts the vent ring seat 36, the contact may block at least one of the flange openings 39. Referring also to fig. 3B, in the exhalation configuration, fluid flow from fluid port 54 causes flap 70 to push down on flange 38 and flange opening 39 to substantially prevent free flow of fluid from the patient through flange opening 39. In this manner, because the flange opening 39 is substantially blocked by the flap 70, the inlet aperture 43 may remain partially or even completely open and exhaled air may still not flow substantially outwardly through the flange opening 39 and then outwardly through the inlet aperture 43. In the exhalation configuration, both sides of the barrier membrane 40 may be in fluid communication with each other via the flange opening 39. Thus, in the inhalation configuration, the inlet channel 41 and the fluid port 54 are not substantially in fluid communication with each other. The flap 70 may be thin and lightweight and substantially impermeable to fluids. For example, the cover sheet 70 may be composed of latex, rubber, silicone, or any other suitable material.

Because flange opening 39 is closed, exhalation of the patient into fluid port 54 causes the pressure in chamber 42 above diaphragm 40 to rise. This pressure rise pushes the flange 38 downward into contact with the vent ring seat 36 or into proximity with the vent ring seat 36 to the exhalation position of the flange 38. If the membrane 40 is bistable, the membrane 40 may be in one of its two bistable configurations in the exhalation configuration seen in FIG. 3A. The use of a bi-stable membrane 40 with a stable configuration in the exhalation configuration means that after reaching the exhalation configuration, the patient does not need to use any exhalation force to maintain the exhalation configuration; thus, the ventilator 2 may be used to treat patients with degraded respiratory ability. If the membrane 40 is stable in a single configuration, the configuration may be the exhalation configuration shown in FIG. 3A.

The vent ring 36 includes one or more breathing windows 78 defined through the sides of the vent ring 36. One or more breathing windows 78 may be positioned at or near the bottom 27 of the vent ring 36. As the vent ring 36 moves downward, the exhalation window 78 moves downward below the lower surface 37 of the vent ring seat 36. The central passage 17 is positioned below the vent ring seat 36 such that when the exhalation window 78 moves below the lower surface 37 of the vent ring seat 36, exhaled air may flow from the chamber 42 above the diaphragm 40, through the exhalation window 78 in the vent ring 26, into the central passage 17 and then out of the respirator 2 through the ambient fluid aperture 4. Thus, in the exhalation configuration, the fluid port 54 and the central passage are in fluid communication with each other.

Operation of

The operation of the respirator 2 will now be described. The fluid port 54 of the ventilator 2 is placed in fluid communication with a ventilator attached to the patient. The ventilator has a flexible sealing surface such that a substantially airtight seal is created against the face of the patient. The patient inhales and exhales from the ventilator into the ventilator. The ventilator is in turn in fluid communication with the airway of the patient. In this manner, the fluid port 54 of the ventilator 2 is placed in fluid communication with the airway of the patient. According to other embodiments, fluid port 54 may be any device other than a ventilator that places fluid port 54 in fluid communication with the airway of a patient; the use of a ventilator to do so is not important to the present invention.

After inhalation by the patient, the pressure above the diaphragm 40 decreases from ambient air pressure. Thus, the diaphragm 40 flexes upward at and near its center. Alternatively, the diaphragm 40 may be biased upward at least partially independent of the patient's inhalation. Upward movement of the diaphragm 40 moves the flange 38 upward because the flange 38 is connected to the diaphragm 40. Because flange 38 is part of valve 20 or is connected to valve 20, upward movement of diaphragm 40 causes valve 20 to move upward. Upward movement of the valve 20 moves the stem 22 upward to thereby move the tapered end 24 of the stem out of the venturi opening 16 and away from the venturi nozzle 14. Because the tapered end 24 of the stem 22 has been removed from the venturi opening 16, oxygen is again free to escape from the venturi opening 16. Thus, in this embodiment, the outflow of oxygen from venturi opening 16 is only mechanically restarted, powered by the patient's inhalation via fluid port 54. As long as the tapered end 24 of the stem 22 is spaced from the venturi opening 16, oxygen flows out of the venturi opening 16. This position of the valve 20 where the stem 22 is spaced from the venturi opening 16 and fluid can flow from the venturi opening 16 is the starting flow position of the valve 20.

Oxygen may be supplied to the fluid inlet 6 from any suitable source. According to some embodiments, high pressure oxygen is connected to a pressure regulator which reduces the pressure of the oxygen and outputs lower pressure oxygen to the fluid inlet 6. In one embodiment, the pressure regulator is from Legacy US companyAdjustable flow regulators, such as U.S. patent application Ser. No. 15/488,319 of 2017, 4, 14 (">File), the entire contents of which are incorporated herein by reference. The U.S. patent application Ser. No. 15/488,319 is a partial continuation of U.S. patent application Ser. No. 14/990,673. Paragraph [0001 ] of U.S. patent application, application Ser. No. 15/488,319, of the original application]In application Ser. No. 15/488,319, U.S. patent application Ser. No. 14/990,673 is also expressly incorporated by reference. The content of U.S. patent application Ser. No. 14/990,673 is hereby incorporated by reference into this disclosure, and specifically, FIGS. 5A, 5B, 7A, 7B, 7C and 7D and the associated text of U.S. patent application Ser. No. 14/990,673. Use->The pressure regulator allows the health care staff to set the patient's pressure and fix it so that it cannot be changed without the use of an adjusting key so that only the health care staff can change it. This provides additional safety for the patient. Furthermore, a plurality of respirators 2 may be connected to the same high pressure oxygen source, and each respirator 2 may receive a different oxygen pressure depending on the +. >And setting a pressure regulator. Like "/->As described in the document, the pressure regulator may include a housing formed to include an internal bore therein and a piston movable within the internal bore, wherein the piston may include an annular lip adjacent an end of the piston. A spring may be disposed within the bore, wherein the spring has two ends, and an adjustment cap is movably disposed in the bore, wherein the adjustment cap may comprise a shapeA key slot formed therein. The first end of the spring may be in physical contact with the annular lip and the second end of the spring may be in physical contact with the adjustment cap. The bore may be defined by a cylindrical wall, and the cylindrical wall may be threaded. The adjustment cap may also have threads such that its threads engage with the threads of the cylindrical wall. Rotating the adjustment cap in the direction may cause the adjustment cap to compress the spring and increase the output pressure of the pressure regulator, and rotating the adjustment cap in the opposite direction may cause the adjustment cap to decompress the spring and decrease the output pressure of the pressure regulator. The adjustment key is detachably connected to the adjustment cap; the adjustment key is detachable from the pressure regulator. Thus, in some embodiments, rotation of the adjustment cap allows the health care worker to set and fix the patient's pressure.

Referring now to fig. 9-14, the pressure regulator 700 includes a housing 510, a piston 760 movably disposed within the housing 510, wherein the piston 760 is formed to include an annular lip 762, a compression spring 720, and an adjustment cap 750. Spring 720 is disposed between annular lip 520 and adjustment cap 750.

Referring now to fig. 12-14, adjustment cap 750 is formed to include threads adjacent a first end thereof. The threads 752 are configured to engage with the internal threads 780 (fig. 11).

Compression spring 720 determines the regulated output pressure in portion 740. Rotating the adjustment cap in a first direction compresses the spring 720 and increases the output pressure in the region 740 (fig. 11) of the regulator 700. Rotating the adjustment cap decompression spring 720 in a second and opposite direction reduces the output pressure in the region 740 (fig. 11) of the regulator 700.

The adjustment cap 750 is further formed to include inwardly extending keyways 754 and 756 in a second end thereof. The adjustment cap 750 is further formed to include an aperture 758 extending therethrough. The shaft 764 of the piston 760 passes through the aperture 758.

Oxygen travels through the fluid inlet 6 and then the channel 12 and then through the venturi nozzle 14 and out the venturi opening 16. The outward flow of oxygen through the venturi opening 16 entrains ambient air entering the respirator 2 through the ambient fluid aperture 4 and draws ambient air into the throat 19 of the venturi 10 where it mixes with the ambient air. Venturi nozzle 14 may be provided with Sized and configured to produce a mixture of ambient air and oxygen that will inhale oxygen (FiO) at a 26% fraction ₂ ) To the patient. FiO (Fio) ₂ Is the recommended oxygen concentration, but other fractions may be used as desired. The accuracy of the oxygen fraction is not important and the fraction can be adjusted as desired by a clinician or other health care worker. For example, fiO ₂ Can be adjusted from 26% to 40% by patient as needed; at the moment of FiO ₂ After adjusting to 40%, if the patient requires additional oxygen, the patient may then be removed from ventilator 2, cannulated and then placed on a currently known ventilator.

The high oxygen air travels upwardly through the central passage 17 to the inlet aperture 43. In the inhalation configuration, the inlet channel 41 is in fluid communication with the central channel 17. As described above, in the inhalation configuration, the vent ring 26 is located in an upward position relative to the venturi nozzle 14. In the inhalation configuration, reduced pressure in chamber 42 above diaphragm 40 caused by inhalation of a patient through fluid port 54 causes diaphragm 40 to move upward. The inhalation withdraws gas from the chamber 42 above the diaphragm 40 to reduce pressure and actuate the valve 20 relative to the venturi nozzle 14. Flange 38 may contact limiter 72 such that flange 38 does not move higher than limiter 72 allows. Upward movement of the diaphragm 40 causes upward movement of the flange 38 attached to the flange 38. Upward movement of the flange 38 causes the valve 20 of which the flange 38 is a part to also move upward. This upward movement of the valve 20 moves the stem 22 away from the venturi nozzle 14 to thereby unseat the barrier venturi opening 16 and allow gas to flow outwardly therefrom. Diaphragm 40 is an example of a pressure multiplier 40 in that the combination of the surface area of diaphragm 40 and flange opening 39 allows for a small differential change in pressure at fluid port 54 to actuate valve 20 between a closed state and an open state.

As described above, in the inhalation configuration, the inlet aperture 43 is open to place the central passage 17 in fluid communication with the inlet passage 41, and both sides of the diaphragm 40 are thus in fluid communication with each other via the flange opening 39; thus, the flange opening 39 places the inlet channel 41 and the fluid port 54 in fluid communication in the suction configuration. Thus, in the inhalation configuration, the central passage 17, inlet passage 41, and fluid port 54 are in fluid communication with one another such that the high oxygen air is free to flow from the venturi nozzle 14 to the fluid port 54, and then to the patient.

The patient inhales normally or as normally as possible. The ventilator 2 is a simple single mode ventilator that does not deliver a specific limited or pre-selected volume or flow rate of air to the patient; instead, it delivers air at a volume and flow rate that is entirely controlled by the patient's own inspiration. Furthermore, the ventilator 2 delivers high oxygen air to the patient only during and shortly after inhalation by the patient. Unlike Continuous Positive Airway Pressure (CPAP) or Positive End Expiratory Pressure (PEEP) ventilation, high oxygen air is supplied to the patient only during inspiration. In this way, the ventilator 2 does not apply pressure to the patient's nose or mouth when the patient attempts to exhale, and does not waste oxygen by applying oxygen to the patient's nose or mouth when the patient is actively exhaling.

After inhalation, the patient then exhales. After expiration of the patient, the pressure above diaphragm 40 increases from ambient air pressure. Referring also to fig. 3B, in the exhalation configuration, fluid flow from fluid port 54 into chamber 42 causes flap 70 to push down on flange 38 and flange opening 39 to substantially prevent free flow of fluid from the patient through flange opening 39. In this manner, because the flange opening 39 is substantially blocked by the flap 70, the inlet aperture 43 may remain partially or even completely open and exhaled air may still not flow substantially outwardly through the flange opening 39 and then outwardly through the inlet aperture 43. In the exhalation configuration, both sides of the barrier membrane 40 may be in fluid communication with each other via the flange opening 39. Thus, in the exhalation configuration, the inlet channel 41 and the fluid port 54 are not substantially in fluid communication with each other.

Because flange opening 39 is closed, exhalation of the patient into fluid port 54 causes the pressure in chamber 42 above diaphragm 40 to rise. That is, the exhalation forces gas into the chamber 42 above the diaphragm 40 to increase the pressure and actuate the valve 20 relative to the venturi nozzle 14. This pressure rise pushes the flange 38 downward into contact with the vent ring seat 36 or into proximity with the vent ring seat 36 to the exhalation position of the flange 38. Because flange 38 is part of valve 20 or is connected to valve 20, this downward movement of diaphragm 40 causes valve 20 to move downward. This downward movement of the valve 20 moves the stem 22 downward to thereby move the tapered end 24 of the stem toward the venturi nozzle 14 and into the venturi opening 16. Because the tapered end 24 of the stem 22 has moved into the venturi opening 16, oxygen is substantially restricted from escaping from the venturi opening 16. Thus, the flow of oxygen from venturi opening 16 is only mechanically stopped, powered by the patient's exhalation through fluid port 54. As long as the tapered end 24 of the stem 22 plugs the venturi opening 16, oxygen is substantially restricted from escaping from the venturi opening 16. This position of the valve 20 in which the stem 22 plugs the venturi opening 16 and substantially restricts fluid flow from the venturi opening 16 is a stopped flow position of the valve 20.

As the flange 38 and vent ring 36 move downward, the exhalation window 78 moves downward below the lower surface 37 of the vent ring seat 36. The central passage 17 is positioned below the vent ring seat 36 such that when the exhalation window 78 moves below the lower surface 37 of the vent ring seat 36, exhaled air may flow from the chamber 42 above the diaphragm 40, through the exhalation window 78 in the vent ring 26, into the central passage 17 and then out of the respirator 2 through the ambient fluid aperture 4. Thus, in the exhalation configuration, the fluid port 54 and the central passage are in fluid communication with each other. The exhaled gas then travels through the central passage 17 and exits the respirator 2 through the ambient fluid aperture 4. When the patient then inhales again, the cycle of the above operation repeats again.

According to some embodiments, because the respirator 2 does not require power to operate, its form factor may be quite small so that the respirator 2 may be portable. The respirator 2 may be worn like a backpack on the back of a user by one or more straps; can be hung on the shoulder as a purse by lacing, can be wheeled as a trunk and can be pulled behind the user or can be otherwise portable. The portability of the respirator 2 also allows the user to take the respirator 2 home. The respirator 2 may be advantageous for home use on patients who have been diagnosed with covd-19 or other respiratory disease but whose symptoms have not progressed to such a severity as to ARDS that they require intubation ventilation. In this way, during a pandemic (e.g., 2020 covd-19 epidemic), patients infected with viruses that cause respiratory problems can be safely treated at home without consuming hospital beds and other hospital resources required for patients with significantly more severe illness and near death.

Because the respirator 2 is small and portable and atraumatic and provides only high oxygen air with a relatively high oxygen concentration to the user, the respirator 2 may be used in other applications. As an example, respirator 2 may be used to treat asthma and/or seasonal allergies. The user wears the respirator described above and respirator 2 functions as described above; the user uses it as a portable device. The increased oxygen concentration delivered by the ventilator 2 may be beneficial to asthmatic patients, and the filter 56 may be used to remove pollen and other allergens from the air before the air may be inhaled by the user to thereby improve the symptoms experienced by users suffering from seasonal allergies. As another example, in extremely contaminated cities, breathing air may be unhealthy. By using the respirator 2 as a portable device, clean oxygen is delivered to the user at a higher concentration than ambient, and the filter 56 may be used to remove particulates and/or other contaminants from the ambient air prior to inhalation by the user.

The respirator 2 described above with respect to figures 1 to 4 may be particularly useful for treating patients infected with the covd-19 virus, particularly before they suffer from ARDS. It is believed that treatment of such patients with ventilator 2 may prevent parts of such patients from suffering from ARDS. It is contemplated that ventilator 2 will be classified by the FDA as a class II medical device and will require approval by the FDA for treatment of a patient. Although the regulatory pathway approved by the FDA for the respirator 2 was unknown by the date of filing of the present invention, it is contemplated that for use as a medical device, the respirator 2 would require at least one of research instrument exemption (IDE), emergency user license (EUA), and pre-market approval (PMA). The independent claims as applied are deemed to cover embodiments of respirator 2 that would undergo applicable FDA approval.

However, ventilator 2 is not limited to use in treating patients infected with the covd-19 virus; the ventilator 2 may be used to treat patients suffering from other afflictions. Furthermore, the respirator 2 may be used in fields other than health care where control of fluid flow is desired, and in such fields it is not necessary to use it in conjunction with humans. Furthermore, the respirator 2 is described above as having components that are in fluid communication with each other and with one or more external accessories (e.g., a ventilator). When the ventilator 2 is used to treat a patient, the fluid in fluid communication is a gas. However, when the respirator 2 is used in other applications, the fluid may be a liquid or a mixture of liquid and gas.

While the embodiments of the present invention described above are directed to facilitating treatment of respiratory conditions associated with covd-19, it is to be appreciated that the fluid mixer 2 has a variety of other uses and applications in other fields, including, but not limited to, the following. As an example, in first-order formula racing and other racing applications, the fluid mixer 2 may be used to pre-spin the turbocharger by detecting pressure changes, actuate cam timing changes based on pressure, actuate fuel/air and exhaust port openings based on pressure, actuate pneumatic down force adjustments based on pressure conditions at sample sites, actuate fuel system pressure adjustments, and regulate the temperature of the fluid. As another example, in standard automotive use, the fluid mixer 2 may be used to actuate turbocharger pre-rotation, actuate cam timing changes, actuate fuel/air and exhaust port opening based on pressure, actuate fuel system pressure regulation and regulate fluid temperature. As another example, in indoor agricultural applications, the fluid mixer 2 may be used to actuate gas mixing based on pressure and/or actuate a pressure communication system. In such applications, the fluid flowing through the fluid mixer 2 may be a liquid, a gas, or both.

Referring also to fig. 5-8, another embodiment of the fluid mixer 2 is shown. This embodiment may be described as a "reverse configuration". This embodiment may be used in automotive or racing applications, but the fluid mixer 2 of fig. 5-8 is not limited to use in such applications. Any of the embodiments may be used with liquids as fluids, gases, or both. As seen in fig. 5 to 8, the valve 20 is in a start-flow position, in which fluid can enter the fluid mixer 2 through the fluid inlet 6. The valve 20 may include a tapered end 24 or other suitably shaped end that is received in the bore 80. The spring 82 may also be received in the bore 80. One end of the spring 82 may engage an end of the bore 80 and the other end of the spring 82 may engage an end of the valve 20. The other end 84 of the valve 20 may be substantially cylindrical or have any other suitable shape. The end 84 of the valve 20 is received in a tube 86 through which fluid may flow. The bore 80 is substantially hollow such that fluid flows from the fluid inlet 6 through the bore 80 and then into the one or more channels 12 when the valve 20 is in the start flow position. As described with respect to the previous embodiments, fluid flows from the one or more channels 12 through the venturi opening 16 in the venturi nozzle 14.

In this embodiment, the pressure multiplier 40 is substantially sealed to the chamber 42 to form a seal plenum 88. Unlike the previous embodiments, the fluid does not substantially traverse the pressure multiplier 40. As fluid flows into the fluid mixer 2 through the fluid ports 54, the fluid flows through the central passage 17 toward the surrounding fluid aperture 4. The chamber 42 opens into the central passage 17 through a chamber opening 90. The chamber opening 90 may have any suitable shape and size. The chamber opening 90 allows fluid communication between the chamber 42 and the central passage 17. As fluid is forced into the central passage 17 through the fluid port 54, the pressure in the central passage 17 increases. The pressure in the chamber 42 on the side of the pressure multiplier 40 opposite the plenum 88 also increases due to fluid communication through the chamber opening 90. Because the pressure multiplier 40 is substantially sealed to the chamber 42 and the fluid is substantially unable to traverse the pressure multiplier 40, the pressure on the pressure multiplier 40 increases to cause the pressure multiplier 40 to move and thus reduce the volume of the plenum 88 to also increase the pressure in the plenum 88. The increased pressure in the plenum 88 is transmitted through the tube 86 to the end 84 of the valve 20. The pressure drives the end 84 of the valve 20 toward the spring 82 in the bore 80 to open the valve 20 to the start flow position. In the start flow position, the tapered end 24 of the valve 20 or other shaped end of the valve 20 moves away from the aperture 92 to allow fluid to flow through the aperture 92 into the bore 80. The volume of the plenum 88 and the volume of the tube 86 may remain substantially constant during this process. This is because the end 84 of the valve 20 in the bore 80 is movable such that any temporary pressure increase and volume decrease of the plenum 88 may be substantially matched by the movement of the end 84 of the valve 20. In this manner, a substantially fixed volume may be defined on the side of the pressure multiplier 40.

As fluid flows into the fluid mixer 2 through the surrounding fluid apertures 4, the fluid flows through the central passage 17 toward the fluid ports 54. As fluid is withdrawn through the fluid port 54, the pressure in the central passage 17 decreases. The pressure in the chamber 42 on the side of the pressure multiplier 40 opposite the plenum 88 is also reduced due to the fluid communication through the chamber opening 90. Because the pressure multiplier 40 is substantially sealed to the chamber 42 and the fluid is substantially unable to traverse the pressure multiplier 40, the pressure on the pressure multiplier 40 decreases to cause the pressure multiplier 40 to move and thus reduce the volume of the plenum 88 to also reduce the pressure in the plenum 88. The reduced pressure in the plenum 88 is transmitted through the tube 86 to the end 84 of the valve 20. The pressure applied to the end 84 of the valve 20 in the bore 80 is reduced to allow the spring 82 to push the end 84 of the valve 20 further into the tube 86. Spring 82 may be a compression spring that biases valve 20 toward the stopped flow position; movement of the valve 20 toward the tube 86 closes the valve 20 to the stopped flow position. In the stopped flow position, the tapered end 24 of the valve 20 or other shaped end of the valve 20 moves toward the aperture 92 and substantially blocks the aperture 92 to substantially block fluid flow through the aperture 92 into the bore 80. According to some embodiments, the start-flow position of the valve 20 is also an active flow position that allows fluid to flow when the valve is in the start-flow position. Alternatively, the valve 20 may be positioned in a different active flow position between a start flow position and a stop flow position; this active flow position may be determined by the level or duration of force with which fluid is forced into the fluid port 54 or withdrawn from the fluid port 54.

Referring now to fig. 15, a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention is shown. The ventilator/device 2 is the ventilator/device described herein, but has a sensor module 1550 positioned between the pressure multiplier and the fluid port. Sensor module 1550 may include any of the sensors described herein, such as pressure sensors, oxygen sensors, carbon dioxide sensors, temperature sensors, humidity sensors, and the like. In this embodiment, the sensor module 1550 further includes a central processing unit.

Referring now to fig. 16, a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention is shown. The respirator/device 2 is the respirator/device described herein, but has a sensor module 1551 positioned between the venturi nozzle and the ambient air aperture. Sensor module 1551 may include any sensor described herein, such as a pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, and the like.

Referring now to fig. 17, a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention is shown. The respirator/apparatus 2 is the respirator/apparatus described herein, but has a sensor module 1750 positioned between the pressure multiplier and the fluid port and a sensor module 1751 positioned between the venturi nozzle and the ambient air aperture. The sensor modules 1750/1751 may include any of the sensors described herein, such as pressure sensors, oxygen sensors, carbon dioxide sensors, temperature sensors, humidity sensors, and the like.

Referring now to fig. 18, a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention is shown. The ventilator/device 2 is the ventilator/device described herein, but has a spirometer 1853 positioned between the pressure multiplier and the fluid port.

Referring now to fig. 19, a side cross-sectional view of a respirator/device 2 is shown in accordance with an embodiment of the present invention. The respirator/device 2 is the respirator/device described herein, but has a spirometer 1954 positioned between the venturi nozzle and the ambient air aperture.

Figure 20 is a side cross-sectional view of a respirator/device according to an embodiment of the present invention having a plurality of spirometers 2053 and 2054 in a plurality of positions. I.e. with a spirometer 2053 positioned between the pressure multiplier and the fluid port and a spirometer 2054 positioned between the venturi nozzle and the surrounding air aperture.

Fig. 21 is a side cross-sectional view of a respirator/device 2 according to an embodiment of the invention having a pitot tube 2155 between a pressure multiplier and a fluid port.

Fig. 22 is a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention having a piezoelectric element 2267 at the limiter 72.

Figure 23 is a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention having sensors, spirometers, pitot tubes, and piezoelectric elements in multiple positions, like reference numerals indicating like features shown in the earlier embodiments.

Fig. 24 is a perspective cut-away view of the respirator/device 2 of fig. 23.

Fig. 25 is a side cross-sectional view of a respirator/device 2 according to an embodiment of the present invention having an active filter 2560 positioned adjacent to the surrounding fluid aperture.

Fig. 26 is a perspective cut-away view of the respirator/device of fig. 25.

Fig. 27 is a flow chart of a method according to an embodiment of the invention. Steps S1-S12 correspond to the steps defined herein.

Fig. 29 is a perspective cut-away view of the respirator/device of fig. 28.

Fig. 30 is a side cross-sectional view of a respirator/device 2 according to an embodiment of the invention having a fluid flow restrictor 3070 in an open position. The ventilator 2 includes an exhalation window 3078 for allowing fluid to exit the ventilator 2 during exhalation and a fluid flow restrictor 3070 for at least selectively partially closing the exhalation window 3078 to set the Positive End Expiratory Pressure (PEEP) of the patient. The fluid flow restrictor 3070 is in the shape of a collar and is positioned adjacent to the vent ring and held in place by a pair of pins 3071 so that it can be selectively adjusted to be linear to select the extent to which the collar blocks the exhalation window 3078.

Fig. 31 is a perspective cut-away view of the respirator/device of fig. 30.

FIG. 32 is a side cross-sectional view of a respirator/device according to an embodiment of the present application having a fluid flow restrictor in a restricted position.

Fig. 33 is a perspective cut-away view of the respirator/device of fig. 30 in an open position.

Strip item

It should be understood that the following items form part of the disclosure of the application defined herein. More particularly, the application may be defined by combinations of features of the strips described in detail below, and such strips may be used to modify combinations of features within the claims of the present application.

1. A ventilator apparatus, comprising:

a venturi nozzle for flow of a pressure controlled fluid;

a surrounding fluid aperture in fluid communication with the venturi nozzle;

a fluid port;

a pressure multiplier in fluid communication with the fluid port; and

A valve movable relative to the venturi nozzle between a start flow position and a stop flow position;

wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve relative to the venturi nozzle.

2. An apparatus suitable for a ventilator, comprising:

a venturi nozzle for flow of a pressure controlled fluid;

a surrounding fluid aperture in fluid communication with the venturi nozzle;

a fluid port;

a pressure multiplier in fluid communication with the fluid port; and

3. The apparatus of clause 1 or clause 2, wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve to a stopped flow position relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve to a start flow position relative to the venturi nozzle.

4. The apparatus of clause 1 or clause 2, wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve to a start-flow position relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve to a stopped flow position relative to the venturi nozzle.

5. The apparatus of clause 1 or clause 2, wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve to an active flow position between the start flow position and the stop flow position relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve to an active flow position between the start flow position and the stop flow position relative to the venturi nozzle.

6. The apparatus of any of clauses 1-5, wherein a pressure-controlled fluid comprises oxygen, a surrounding fluid comprises ambient air, fluid forced into the fluid port comprises air exhaled into an air port, and fluid withdrawn from the fluid port comprises air inhaled from the air port.

7. The apparatus of any one of clauses 1 to 5, wherein the pressure multiplier is positioned between the venturi nozzle and the fluid port.

8. The apparatus of any one of clauses 1 to 5, wherein the venturi nozzle is positioned between the pressure multiplier and the fluid port.

9. The apparatus of any one of clauses 1-5, wherein the venturi nozzle is positioned between the surrounding fluid aperture and the fluid port.

10. The apparatus of any one of clauses 1 to 9, comprising a pressure regulator for regulating the flow of a pressure controlled fluid, the pressure regulator comprising:

a housing formed to include an inner bore therein;

a piston movably disposed within the bore, wherein the piston includes an annular lip adjacent a first end thereof;

a spring disposed within the bore and including a first end and a second end;

an adjustment cap movably disposed in the bore, wherein the adjustment cap is formed to include a plurality of keyways formed therein;

wherein:

the first end of the spring is in physical contact with the annular lip; and is also provided with

The second end of the spring is in physical contact with the adjustment cap, wherein:

rotating the adjustment cap in a first direction causes the adjustment cap to compress the first spring;

Rotating the adjustment cap in a second and opposite direction causes the adjustment cap to decompress the spring;

rotating the adjustment cap in the first direction increases the output pressure of the pressure regulator;

rotating the adjustment cap in the second direction reduces the output pressure of the pressure regulator;

the bore is defined by a cylindrical wall;

the cylindrical wall is formed to include a first thread therein;

the adjustment cap is formed to include a second thread formed on a periphery thereof;

the second thread is configured to engage with the first thread.

11. The apparatus of any one of clauses 1-10, wherein the pressure multiplier comprises a diaphragm.

12. The apparatus of any one of clauses 1 to 11, wherein the pressure multiplier is bistable.

13. The apparatus of any one of clauses 3 to 12, wherein the pressure multiplier is biased toward the stopped flow position.

14. The apparatus of any one of clauses 3 to 12, wherein the pressure multiplier is biased toward the start flow position.

15. The apparatus of any one of clauses 1 to 10, wherein the pressure multiplier comprises at least one cover slip.

16. The apparatus of any one of clauses 1 to 15, wherein the apparatus is entirely mechanical.

17. The apparatus of any one of clauses 3 to 16, wherein in the start flow position or active flow position, a mixture of pressure controlled fluid and ambient fluid is allowed to flow to the fluid port.

18. The apparatus of clause 17, wherein the flow of the mixture is modulated in real time.

19. The apparatus of any one of clauses 1 to 18, wherein the valve includes a flange connected to the pressure multiplier.

20. The apparatus of any one of clauses 1 to 18, wherein the valve comprises a stem having a tapered end, wherein the tapered end enters a venturi opening in the venturi nozzle in the stopped position to substantially close the venturi opening.

21. The apparatus of clause 20, wherein the rod is connected to the pressure multiplier.

22. The apparatus of any one of clauses 1 to 18, wherein the valve comprises a switch.

23. The apparatus of any one of clauses 1 to 18, wherein the valve comprises a flapper valve.

24. The apparatus of any one of clauses 1 to 18, wherein the valve comprises a spring-loaded shuttle system.

25. The apparatus of any one of clauses 1 to 18, wherein the valve is slidable.

26. The apparatus of any one of clauses 1 to 25, wherein the valve is entirely mechanical.

27. The apparatus of any one of clauses 1 to 26, wherein the surrounding fluid aperture comprises a fluid discharge.

28. The apparatus of clause 27, wherein the valve is configured to actuate relative to the venturi nozzle while opening the fluid discharge port.

29. The apparatus of any one of clauses 1 to 28, further comprising at least one filter detachably connected to the surrounding fluid aperture.

30. The apparatus of clause 29, wherein the at least one filter comprises pores of about 3 μm.

31. The apparatus of any one of clauses 1 to 30, further comprising a ventilator.

32. The apparatus of clause 31, wherein the ventilator is in fluid communication with the fluid port.

33. The apparatus of any one of clauses 1 to 32, wherein the fluid is a liquid.

34. The apparatus of any one of clauses 1 to 33, wherein the apparatus is injection molded.

35. The apparatus of any one of clauses 1 to 33, wherein the apparatus is 3D printed.

36. The apparatus of any one of clauses 1 to 35, wherein the apparatus is configured to be mobile.

37. The apparatus of any one of clauses 1 to 36, wherein the apparatus is configured to be reusable.

38. The apparatus of any one of clauses 1 to 37, for controlling the flow of air and/or oxygen into a ventilator.

39. The apparatus of any one of clauses 1 to 38 for controlling the flow of purified air and/or oxygen into a ventilator.

40. The device of any one of clauses 1 to 39, for use in treating a respiratory condition.

41. The device of any one of clauses 1 to 40, for use in treating covd-19.

42. A method of using an apparatus suitable for a ventilator, the method comprising:

providing a pressure controlled fluid source;

an apparatus suitable for a ventilator is provided comprising:

a venturi nozzle for receiving a flow of the pressure controlled fluid;

a surrounding fluid aperture in fluid communication with the venturi nozzle;

a fluid port;

a pressure multiplier in fluid communication with the fluid port; and

A valve movable relative to the venturi nozzle between a start flow position and a stop flow position in which the pressure-controlled fluid mixes with the ambient fluid;

Actuating the valve relative to the venturi nozzle in response to fluid being forced into the fluid port; and

The valve is actuated relative to the venturi nozzle in response to fluid withdrawal from the fluid port.

43. The method of clause 42, wherein the device is entirely mechanical.

44. The method of clause 42 or clause 43, further comprising adjusting the pressure of the pressure controlled fluid.

45. The method of any one of clauses 42 to 44, wherein the method is for treating a living patient inhaling and exhaling gas using the apparatus, wherein the pressure controlled fluid is pressure controlled oxygen, and wherein the fluid is air, the method comprising:

connecting the device to a ventilator;

placing the ventilator in gaseous communication with the patient and the pressure controlled oxygen source;

initiating flow of oxygen into the ventilator in response to inhalation by the patient, mixing the oxygen with ambient air to produce high oxygen air and delivering the high oxygen air to the patient;

stopping flow of oxygen into the ventilator and exhausting exhaled air from the ventilator in response to the patient exhaling.

46. The method of clause 45, wherein the high oxygen air has a FiO of at least 26% ₂ 。

47. The method of any one of clauses 42 to 44, wherein the method is for treating a living patient inhaling and exhaling gas using the apparatus, wherein the pressure controlled fluid is pressure controlled filtered air, and wherein the fluid is air, the method comprising:

connecting the device to a ventilator;

placing the ventilator in gaseous communication with the patient and the pressure-controlled filtered air source;

initiating flow of oxygen into the ventilator in response to inhalation by the patient, mixing the pressure-controlled filtered air with ambient air to produce purified air and delivering the purified air to the patient;

48. The method of clause 47, wherein the purified air has a FiO of at least 26% ₂ 。

49. The method of any one of clauses 42 to 48, further comprising walking and/or running while utilizing the apparatus and ventilator.

50. The method of any one of clauses 42 to 49, further comprising eliciting the use of the apparatus and ventilator to treat allergy.

51. The method of any one of clauses 42 to 49, further comprising initiating use of the apparatus and ventilator to treat ARDS.

52. The method of any one of clauses 42 to 49, further comprising eliciting the use of the apparatus and ventilator to treat sleep apnea.

53. The method of any one of clauses 42 to 49, further comprising initiating use of the apparatus and ventilator to treat COPD.

54. The method of any one of clauses 42 to 49, further comprising eliciting the use of the device and ventilator to treat an infection with a covd-19 virus.

55. The method of any one of clauses 42 to 54, further comprising filtering the ambient air.

56. The method of any of clauses 42 to 55, further comprising filtering exhaled gas from the patient.

57. A pressure multiplier comprising a sealed end and an open end, wherein the sealed end is in fluid communication with a valve to define a fixed volume between the sealed end and the valve, wherein the pressure multiplier is configured such that a pressure change of the open end causes a pressure change of the sealed end to actuate the valve.

58. The pressure multiplier of clause 57, configured such that the negative pressure of the open end causes the pressure of the sealed end to decrease to actuate the valve.

59. The pressure multiplier of clause 57, configured such that positive pressure of the open end causes pressure of the sealed end to increase to actuate the valve.

60. The pressure multiplier of any one of clauses 57 to 59, wherein the actuation of the valve activates a humidifier.

61. The pressure multiplier of any of clauses 57-59, wherein the actuation of the valve produces a change in a visual pointer.

62. The pressure multiplier of clause 61, wherein the visual pointer change is indicative of a pressure change of the open end.

63. The pressure multiplier of clause 62, wherein the pressure change of the open end is caused by inhalation and/or exhalation by the patient.

As used in this disclosure (both the description and the claims) and as is common in the art, the terms "substantially," "approximately," and similar approximations are used to denote the terms of manufacture tolerances, manufacturing variations and manufacturing inaccuracies, which are an unavoidable portion of any mechanism or structure in the manufacturing entity world.

Although the application has been described in detail, it will be apparent to those skilled in the art that various changes and modifications can be made, and equivalents employed, without departing from the application. It is to be understood that the application is not limited to the details of construction, arrangement of components and/or methods set forth in the above description or illustrated in the drawings. The recitation of the abstract of the application and any generic recitation of the application are merely exemplary; it should not be interpreted as limiting the scope of the claims. Further, the drawings are merely illustrative and not limiting. The thematic title and the subtitle are only for the convenience of the reader. It should not be construed and should not be construed to have any substantial meaning, meaning or interpretation, and should not be construed as indicating that all information related to any particular topic is found under or limited to any particular title or subtitle. The purpose of the abstract of the present application is to enable the U.S. patent and trademark office and the reader not familiar with patent or legal terms or phraseology to determine quickly from a reading the nature and essence of the technical disclosure of the present application. The abstract is neither intended to define the application, nor is it intended to be limiting as to the scope of the application. The purpose of the present application is to provide support for the claims of any subsequently applied foreign patent application claiming priority to the present application. The items are not intended to define the application, nor are they intended to limit the scope of the application. Accordingly, the present application is limited only by or by the following claims and their legal equivalents.

Claims

1. A ventilator connectable to an airway of a living patient, comprising:

a venturi tube comprising a throat;

a venturi nozzle;

a venturi opening in the venturi nozzle through which pressure controlled oxygen flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned;

a surrounding air aperture in fluid communication with the venturi nozzle and surrounding air;

a fluid port in fluid communication with the airway of the patient;

a pressure multiplier in fluid communication with the fluid port, wherein the pressure multiplier includes at least one opening defined therethrough; the pressure multiplier includes at least one flap movable relative to the at least one opening between an open position and a closed position; and

A valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes the flow of pressure controlled oxygen to entrain the ambient air into the throat and a stop flow position that stops the flow of pressure controlled oxygen from entraining the ambient air into the throat;

Wherein the pressure multiplier is configured to cause the patient to exhale into the fluid port to actuate the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle;

wherein the pressure multiplier is configured such that inhalation by the patient through the fluid port actuates the valve along the axis of movement relative to the venturi nozzle;

wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat; and is also provided with

Including at least one of a sensor, a measuring device, and a power generation device, positioned between at least one of:

the venturi nozzle and the ambient air aperture; and

The pressure multiplier and the fluid port; and is also provided with

Wherein at least one of the sensor, measuring device and power generating device comprises at least one of: pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, piezoelectric generator, spirometer measuring device, pitot measuring probe, and spirometer generator.

2. The respirator of claim 1, wherein at least one of the sensor, measurement device, and power generation device is positioned between the venturi nozzle and the ambient air aperture, and at least one of the sensor, measurement device, and power generation device is positioned between the pressure multiplier and the fluid port.

3. The respirator of claim 1, wherein to collect differential data, at least one of the sensor, measurement device, and power generation device is positioned between the venturi nozzle and the ambient air aperture, and at least one of the same type of sensor, measurement device, and power generation device is positioned between the pressure multiplier and the fluid port.

4. The respirator of claim 1, comprising a central processing unit for packaging raw data collected by at least one of the sensor, measurement device, and power generation device.

5. The respirator of claim 1, comprising a motion sensor.

6. The ventilator of claim 1, comprising an exhalation window for allowing fluid to leave the ventilator during exhalation and a fluid flow restrictor for at least selectively partially closing the exhalation window to set Positive End Expiratory Pressure (PEEP) for the patient.

7. An apparatus suitable for use with a ventilator, comprising:

a venturi, comprising:

a throat;

a venturi nozzle; and

A venturi opening in the venturi nozzle through which a pressure-controlled fluid flows outwardly, wherein the venturi opening opens into the throat, and wherein the venturi opening and the throat are substantially longitudinally aligned;

A surrounding fluid aperture in fluid communication with the venturi nozzle and surrounding fluid;

a fluid port;

a pressure multiplier in fluid communication with the fluid port; and

A valve movable along a movement axis relative to the venturi opening in the venturi nozzle between a start flow position that causes entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid and a stop flow position that stops entrainment of the ambient fluid into the throat by the flow of pressure-controlled fluid;

wherein the pressure multiplier is configured such that fluid forced into the fluid port actuates the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle;

wherein the pressure multiplier is configured such that fluid withdrawn from the fluid port actuates the valve along the axis of movement relative to the venturi nozzle;

wherein the axis of movement of the valve is substantially longitudinally aligned with a longitudinal direction of the throat;

wherein the pressure multiplier is positioned between the venturi nozzle and the fluid port; and is also provided with

The venturi nozzle and the surrounding fluid aperture; and

The pressure multiplier and the fluid port; and is also provided with

8. The apparatus of claim 7, wherein at least one of the sensor, measuring device, and generating device is positioned between the venturi nozzle and the ambient air aperture, and at least one of the sensor, measuring device, and generating device is positioned between the pressure multiplier and the fluid port.

9. The apparatus of claim 7, wherein to collect differential data, at least one of the sensor, measuring device, and generating device is positioned between the venturi nozzle and the ambient air aperture, and at least one of the same type of sensor, measuring device, and generating device is positioned between the pressure multiplier and the fluid port.

10. The apparatus of claim 7, comprising a central processing unit for packaging raw data collected by at least one of the sensor, measurement device, and power generation device.

11. The apparatus of claim 7, comprising a motion sensor.

12. The apparatus of claim 7, comprising at least one fluid gate for allowing fluid to leave the apparatus when fluid is forced into the fluid port and a fluid flow restrictor for at least selectively partially closing the at least one fluid gate.

13. The apparatus of claim 7, wherein the pressure multiplier is configured such that the fluid forced into the fluid port actuates the valve to the stopped flow position along the axis of movement relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that the fluid withdrawn from the fluid port actuates the valve to the start flow position along the axis of movement relative to the venturi nozzle.

14. The apparatus of claim 7, wherein the pressure multiplier is configured such that the fluid forced into the fluid port actuates the valve to the start flow position along the axis of movement relative to the venturi nozzle; and is also provided with

Wherein the pressure multiplier is configured such that the fluid withdrawn from the fluid port actuates the valve to the stopped flow position along the axis of movement relative to the venturi nozzle.

15. The apparatus of claim 7, further comprising a pressure regulator for regulating the flow of the pressure controlled fluid, the pressure regulator comprising:

a housing formed to include an inner bore therein;

a spring disposed within the bore and including a first end and a second end;

wherein:

the bore is defined by a cylindrical wall;

the cylindrical wall is formed to include a first thread therein;

the adjustment cap is formed to include a second thread formed on a periphery thereof; and is also provided with

The second thread is configured to engage with the first thread.

16. The apparatus of claim 7, wherein the pressure multiplier comprises a diaphragm.

17. The apparatus of claim 7, wherein the valve comprises a stem having a tapered end, wherein the tapered end enters the venturi opening in the venturi nozzle in the stopped position to substantially close the venturi opening.

18. The apparatus of claim 7, further comprising at least one filter detachably connected to the surrounding fluid aperture.

19. The apparatus of claim 7, wherein the pressure-controlled fluid is a liquid.

20. A method of collecting data from a patient using a device suitable for a ventilator, the method comprising:

Providing a pressure controlled oxygen source;

providing an apparatus suitable for a respirator, the apparatus comprising:

a venturi tube comprising a throat;

a venturi nozzle;

a surrounding fluid aperture in fluid communication with the venturi nozzle and surrounding air;

a fluid port;

placing the fluid port in fluid communication with the airway of the patient;

In response to the patient exhaling through the fluid port,

causing the at least one flap to move to the closed position relative to the at least one opening and actuating the valve along the axis of movement relative to the venturi nozzle to close the venturi nozzle; and

In response to the patient inhaling through the fluid port,

causing the at least one flap to move to the open position relative to the at least one opening and actuate the valve along the axis of movement relative to the venturi nozzle; and is also provided with

Wherein the axis of movement of the valve is substantially longitudinally aligned with the longitudinal direction of the throat; and is also provided with

the venturi nozzle and the ambient air aperture; and

The pressure multiplier and the fluid port; and is also provided with

Wherein at least one of the sensor, measuring device and power generating device comprises at least one of: pressure sensor, oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor, piezoelectric generator, spirometer measuring device, pitot measuring probe and spirometer generator; and

Collecting raw data using the at least one of the sensor, measurement device, and power generation device;

encapsulating the collected raw data using a central processing unit;

transmitting the encapsulated raw data to a receiving device using a wired or wireless communication link;

receiving the encapsulated data on the receiving device;

unsealing the collected raw data;

quantifying the unsealed raw data;

formatting the quantized data;

analyzing the formatted data;

distributing the analyzed data; and

An application is used to display the analyzed data.

21. The method of claim 20, comprising the step of coupling the central processing unit to the respirator.

22. The method of claim 20, wherein using the wireless communication link comprises using at least one wireless protocol selected from Bluetooth, wi-Fi, and Thread.

23. The method of claim 20, wherein using the wired communication link comprises using at least one of USB, serial, single-wire, and parallel.

24. The method of claim 20, comprising displaying the analyzed data using a smart device.

25. The method of claim 24, wherein the smart device comprises at least one of a mobile communication device, a tablet computer, a patient interface display, a laptop computer, and a desktop computer.

26. An active filter comprising at least one piezoelectric element and at least one dielectric filter medium, wherein the piezoelectric element generates electricity to induce electrostatic charge in the dielectric filter medium.

27. The active filter of claim 26, wherein the power generated by the at least one piezoelectric element is AC.

28. The active filter of claim 26, comprising at least one spirometer that generates electricity to induce an electrostatic charge in the at least one dielectric filter media.

29. The active filter of claim 28 comprising two spirometers that generate electricity to induce an electrostatic charge in the at least one dielectric filter media.

30. The active filter of claim 28 wherein the power generated by the at least one spirometer is DC.