WO2021199030A1

WO2021199030A1 - Respirator

Info

Publication number: WO2021199030A1
Application number: PCT/IL2021/050347
Authority: WO
Inventors: Liron Elia; Gavriel J. Iddan
Original assignee: ART MEDICAL Ltd.
Priority date: 2020-03-28
Filing date: 2021-03-26
Publication date: 2021-10-07

Abstract

There is provided a respirator system, comprising: a mask made of a flexible material including filter(s) forming a passive air flow channel for transfer of air across the mask, a ventilator connected to tubing connected to an aperture(s) of the mask, generating an active air flow channel, a closure mechanism on the mask closes the aperture when the tubing is removed, thereby switching from operating with the active air flow channel in an active mode to the mask operating using the passive air flow channel in a passive mode, and a controller that iterates over each breathing cycle: receives a target baseline air pressure for the region defined by the inner surface of the mask when worn, dynamically generating instructions for real time adaptation of the ventilator RPM for adjusting the air delivered by the active air channel for maintaining a target baseline air in the region of the mask.

Description

RESPIRATOR

RELATED APPLICATIONS

This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/001,300 filed on March 28, 2020, and U.S. Provisional Patent Application No. 63/111,697 filed on November 10, 2020, the contents of which are incorporated by reference as if fully set forth herein in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to masks and, more specifically, but not exclusively, to systems and methods for a respirator system including a mask.

During viral disease outbreaks (e.g., COVID-19), simple masks are commonly worn by many people, in an effort to try to reduce risk of spreading viral disease and/or reduce risk of contracting viral disease. Such masks may be simple, for example, disposable surgical masks and/or a piece of fabric cut to fit over the mouth and nose.

SUMMARY OF THE INVENTION

According to a first aspect, a respirator system, comprises: a mask made of a flexible material that conforms to facial features of a user when worn and collapses when not worn, the mask including at least one filter positioned within an inner surface of the mask that when in use is located in proximity to a nose and mouth of the user, the at least one filter forming a passive air flow channel for transfer of air across the mask, the mask including at least one aperture and a closure mechanism, a ventilator connected to tubing connected to the at least one aperture of the mask, the ventilator generating an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask, wherein the closure mechanism located on the mask closes the aperture when the tubing is removed, thereby switching the mask from operating with the active air flow channel in an active mode to the mask operating using the passive air flow channel in a passive mode, and a controller configured for: receiving an indication of a target baseline air pressure for the region defined by the inner surface of the mask when worn by the user, receiving an indication of a real time air pressure at the region, and dynamically generating instructions for real time adaptation of the ventilator RPM for adjusting the air delivered by the active air channel for maintaining the target baseline air pressure, wherein the receiving the indication of the real time air pressure and the dynamically generating instructions are iterated a plurality of times over each one of a plurality of breathing cycles of the user. According to a second aspect, a system for maintaining a target baseline air pressure in a region of a mask, comprises: at least one hardware processor executing a code for: receiving an indication of a target baseline air pressure for the region defined by the inner surface of the mask when worn by the user, wherein the mask is made of a flexible material that conforms to facial features of the user when worn and collapses when not worn, the mask including at least one aperture for communication with a tube within which is established an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask by a ventilator, receiving an indication of a real time air pressure at the region, and dynamically generating instructions for real time adaptation of the ventilator for adjusting the air delivered by the active air channel maintaining the target baseline air pressure, wherein the receiving the indication of the real time air pressure and the dynamically generating instructions are iterated a plurality of times over each one of a plurality of breathing cycles of the user.

According to a third aspect, a respirator system, comprises: a mask made of a flexible material that conforms to facial features of a user when worn and collapses when not worn, the mask including at least one filter positioned within an inner surface of the mask that when in use is located in proximity to a nose and mouth of the user, the at least one filter forming a passive air flow channel for transfer of air across the mask, the mask including at least one aperture and a closure mechanism, a ventilator connected to tubing connected to the at least one aperture of the mask, the ventilator generating an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask, and wherein the closure mechanism located on the mask closes the aperture when the tubing is removed, thereby switching the mask from operating with the active air flow channel in an active mode to the mask operating using the passive air flow channel in a passive mode.

In a further implementation form of the first, second, and third aspects, the mask includes a first aperture connected to a first tube connected to the ventilator and associated with a first closure mechanism, and a second aperture connected to a second tube connected to the ventilator and associated with a second closure mechanism, wherein the active air flow channel generated by the ventilator includes air flowing from the ventilator through the first tube to the region of the mask and air flowing from the region of the mask through the second tube to the ventilator.

In a further implementation form of the first, second, and third aspects, further comprising a first filter associated with at least one of the first aperture, the first tube, and an air entry port of the ventilator, and a second filter associated with at least one of the second aperture, the second tube, and an air exit port of the ventilator. In a further implementation form of the first, second, and third aspects, the ventilator includes an air entry portion for delivery of air to the first tube and an air exhalation portion that evacuates air from the second tube, the air entry portion and the air exhalation portion housed within a single common housing of the ventilator and are hermetically sealed from one another.

In a further implementation form of the first, second, and third aspects, the air entry portion includes an air entry blower, and the air exhalation portion includes an air exhalation blower, the air entry blower and air exhalation blower are independently controlled by a controller to achieve a synergistic effect in establishing the active air channel, and/or may be independently dynamically adapted to maintain a target air pressure within the region defined by the inner surface of mask during use.

In a further implementation form of the first, second, and third aspects, further comprising a barrier of the single common housing that is diagonally, creating a larger air entry chamber with entry and exit ports along a straight axis where air flow delivered to the mask is substantially along the straight axis, and a smaller air evacuation chamber when entry and exit ports are along an angle and/or curve, wherein air flow received from the mask is directed along the angle and/or curve.

In a further implementation form of the first, second, and third aspects, an inlet port of an air entry chamber including the air entry blower and an outlet port of an air evacuation chamber including the air exhalation blower are located along a straight axis, the air entry chamber and air evacuation chamber being hermetically separated by a barrier positioned perpendicular to the straight axis.

In a further implementation form of the first, second, and third aspects, an outlet port of the air entry chamber configured for connecting to the first tube and an inlet port of the air evacuation chamber configured for connecting to the second tube, are positioned side by side along a housing of the ventilator.

In a further implementation form of the first, second, and third aspects, the ventilator includes a screen designed to be opened and closed, the screen including a flexible frame that changes size for accommodating a variety of sizes of a disposable and replaceable filter.

In a further implementation form of the first, second, and third aspects, the aperture comprises an inhalation port, wherein the tubing is connected to the inhalation port for establishment of the active air flow channel, and during disconnection of the tubing the closure mechanism closes the inhalation port for switching from the active air flow channel to the passive air flow channel. In a further implementation form of the first, second, and third aspects, the active air flow channel comprises an active filtered air low channel, wherein the ventilator includes a filter for generating the active filtered air flow channel.

In a further implementation form of the first, second, and third aspects, the closure mechanism includes at least one leaflet and at least one tension element that is set to apply a stored tension force, when the tube is disconnected from the aperture, to urge the at least one leaflet to change orientation from a first state where the aperture is open to a second state for closing the aperture, and when the tube is connected to the aperture, tension is stored in the at least one tension element tension element by a change in orientation of the at least one leaflet from the second state to the first state, wherein when the aperture is closed by the closure mechanism, the mask operates in the passive mode, wherein air exhaled and inhaled by the user is transported by the passive air flow channel via the at least one filter mounted on inner surface of the mask.

In a further implementation form of the first, second, and third aspects, tension applied by the at least one tension element to the tube within the aperture secures the tube in place within the aperture.

In a further implementation form of the first, second, and third aspects, the at least one leaflet is set on a hinge for changing orientation from the first state to the second state, and the at least one tension element is associated with the hinge.

In a further implementation form of the first, second, and third aspects, the mask includes a wide central portion and a left arm portion and a right arm portion extending from the wide central portion, at least one of the left arm portion and the right arm portion located in proximity to an aperture and including a tube connector for connecting at least a portion of the tube along a long axis of the respective left arm portion and/or right arm portion, while the mask is in use and while the tube is connected to the respective aperture and to the ventilator.

In a further implementation form of the first, second, and third aspects, the connector comprises a tunnel formed by an inner surface of at least one of the left arm portion and the right arm portion, the tunnel sized for including the portion of the tube encapsulated by the inner surface.

In a further implementation form of the first, second, and third aspects, a cross section of the portion of the tube along the long axis includes a straight portion that contacts the left arm portion and/or the right arm portion and a curved arc shaped portion connected to the straight portion, the curved arc shaped portion does not contact the left arm portion and/or the right arm portion.

In a further implementation form of the first, second, and third aspects, the portion of the tube located along the long axis is integrated with the respective left arm portion and/or right arm portion, and wherein the portion of the tube further includes a connector at the distal end thereof for detachably connecting to a second tube connected to the ventilator.

In a further implementation form of the first, second, and third aspects, further comprising an elbow connector having a curve selected to connect between the aperture and the portion of the tube located along the long axis.

In a further implementation form of the first, second, and third aspects, the elbow connector is set for connecting to the aperture of the mask, for rotation relative to the aperture, and for detaching from the connection to the aperture of the mask by rotation and pulling of the elbow connected.

In a further implementation form of the first, second, and third aspects, further comprising: at least one air filter included in the ventilator, the at least one air filter including an indication element, an indicator reading element included in the ventilator, the indicator reading element sensing the indication element, at least one pressure sensor that senses pressure of the active air channel, and a non-transitory memory storing code instructions that when executed by at least one hardware processor cause the hardware processor to: estimate when the at least one air filter is to be replaced according to an analysis of dynamic pressure changes of the active air channel passing through the at least one air filter sensed by the at least one pressure sensor.

In a further implementation form of the first, second, and third aspects, the indication element stores an indication of a lifetime of the at least one air filter when used during a baseline pressure environment, and wherein the analysis of dynamic pressure changes of the active air channel passing through the at least one air filter reduces the lifetime when the dynamic pressure changes are above the baseline pressure environment.

In a further implementation form of the first, second, and third aspects, the ventilator further comprises an inlet matching element that includes a first inlet having a larger size substantially corresponding to dimensions of an inlet filter of the ventilator, and a second inlet having a smaller size substantially corresponding to dimensions of a ventilator inlet of a blower of the ventilator.

In a further implementation form of the first, second, and third aspects, the controller is further configured for receiving a measurement of at least one sensor sensing the region, and adjusting an amount of supplemental oxygen delivered by the ventilator to the region via the active air flow channel according to the measurement of the at least one sensor.

In a further implementation form of the first, second, and third aspects, the target baseline air pressure is defined as an air pressure increase over an ambient air pressure of an environment external to the mask. In a further implementation form of the first, second, and third aspects, when the indication of the real time air pressure denotes a decrease in air pressure during an inspiration phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for increasing the air delivered by the active air channel.

In a further implementation form of the first, second, and third aspects, when the indication of the real time air pressure denotes an increase in air pressure in the region defined by the inner surface of the mask during an exhalation phase of a breathing cycle and/or during increased physical activity by the user, the instructions are for decreasing the air pressure delivered by the active air channel to the region defined by the inner surface of the mask, for maintaining the target baseline air pressure.

In a further implementation form of the first, second, and third aspects, when the indication of the real time air pressure denotes an increase in air pressure in the region defined by the inner surface of the mask during an exhalation phase of a breathing cycle and/or during increased physical activity by the user, the instructions are for increasing the air removed from the region defined by the inner surface of the mask by the active air channel, for maintaining the target baseline air pressure.

In a further implementation form of the first, second, and third aspects, when the indication of the real time air pressure denotes a decrease in air pressure in the region defined by the inner surface of the mask during an inspiratory phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for increasing the air pressure delivered by the active air channel to the region defined by the inner surface of the mask, for maintaining the target baseline air pressure.

In a further implementation form of the first, second, and third aspects, when the indication of the real time air pressure denotes a decrease in air pressure in the region defined by the inner surface of the mask during an inspiratory phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for decreasing the air removed from the region defined by the inner surface of the mask by the active air channel, for maintaining the target baseline air pressure.

In a further implementation form of the first, second, and third aspects, the instructions are generated for parallel execution by an air entry blower that delivers air into the mask, and for an air evacuation blower that evacuates air out of the mask.

In a further implementation form of the first, second, and third aspects, the instructions for execution by the air entry blower are to increase the amount of air delivered to the region and the instructions may be for execution by the air evacuation blower to decrease the amount of air evacuated from the region.

In a further implementation form of the first, second, and third aspects, the instructions for execution by the air evacuation blower are to increase the amount of air evacuated from the region, and the instructions for execution by the air entry blower are to decrease the amount of air evacuated from the region.

In a further implementation form of the first, second, and third aspects, the instructions are generated for a single blower that delivers air to the region via the active air channel, wherein exhalation is via a passive air channel across the air filter of the mask, the instructions are for increasing air delivery and/or decreasing air delivery for maintaining the target baseline air pressure.

In a further implementation form of the first, second, and third aspects, the target baseline air pressure is selectable and/or adjustable by the user by an interface connected to the ventilator, wherein the selected and/or adjusted target baseline air pressure is maintained.

In a further implementation form of the first, second, and third aspects, an air flow rate of the active air channel is automatically adjusted by the ventilator a user requirement of a higher breathing rate, as sensed by one or more sensors.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. In the drawings:

FIG. 1 is a schematic of a high level block diagram of components of a system for ventilation of a user, in accordance with some embodiments of the present invention;

FIG. 2 includes schematics depicting a baseline mask with an exhalation valve that is adapted for active air flow, in accordance with some embodiments of the present invention;

FIG. 3A is a schematic depicting, from a side view, a mask connected to a ventilator for establishment of the active air channel and/or dynamic adaptation of pressure, in accordance with some embodiments of the present invention;

FIG. 3B is a schematic depicting, from a back view, the mask connected to the ventilator for establishment of the active air channel and/or dynamic adaptation of pressure of FIG. 3A, in accordance with some embodiments of the present invention;

FIG. 3C is a schematic depicting mask with an optional oxygen sensor(s) and/or an optional oxygen saturation sensor(s), in accordance with some embodiments of the present invention;

FIG. 4 is a schematic of an exemplary implementation of a ventilator that establishes an active air channel and/or optionally dynamically adjusts the active air delivery to maintain a target air pressure in a region established by the inner surface of mask when in use, in accordance with some embodiments of the present invention;

FIG. 5 is a block diagram of exemplary electronic components in a respirator system, in accordance with some embodiments of the present invention;

FIG. 6 is a schematic of a mask for which an active air channel is established for insertion of air and evacuation of air, in accordance with some embodiments of the present invention;

FIG. 7 is a flowchart depicting an exemplary flow for switching between an active air channel and a passive air channel in the respirator system, in accordance with some embodiments of the present invention;

FIG. 8 is an exemplary architecture of a ventilator including an air entry portion for active delivery of air to the mask, and a separate air exhalation portion for active evacuation of air from the mask, in accordance with some embodiments of the present invention;

FIG. 9A is an exemplary architecture of another ventilator including an air entry portion for active delivery of air to the mask, and a separate air exhalation portion for active evacuation of air from the mask, in accordance with some embodiments of the present invention;

FIG. 9B is a schematic of an exemplary inlet into a ventilator that includes an inlet matching element, in accordance with some embodiments of the present invention; FIG. 10 is a schematic of a replaceable filter, including a support frame, and an indicator for estimating an amount of remaining time before filter is to be replaced, in accordance with some embodiments of the present invention;

FIG. 11 is a schematic depicting a replaceable filter with an indicator located within a ventilator that includes an indicator reader element designed to read the code of indicator, in accordance with some embodiments of the present invention;

FIG. 12 is a schematic depicting separate components illustrating a process of replacing a disposable and/or replaceable filter within a cover with screen of a ventilator, in accordance with some embodiments of the present invention;

FIG. 13 is a schematic depicting a smartphone connected to the ventilator and/or computing device, used as an interface thereof, in accordance with some embodiments of the present invention;

FIG. 14 is a schematic depicting an example of a closure mechanism of the mask, in accordance with some embodiments of the present invention;

FIG. 15 is a schematic depicting another example of a closure mechanism of a mask that automatically closes an aperture when a tube is disconnected, in accordance with some embodiments of the present invention;

FIG. 16 is a schematic of a cross section of a ventilator, depicting a tube attached to a port of ventilator, in accordance with some embodiments of the present invention;

FIG. 17 is a schematic of a mask including a portion of a tube positioned along a left arm portion and/or a right arm portion, in accordance with some embodiments of the present invention;

FIG. 18 is another schematic of another mask including a portion of a tube positioned along a left arm portion and/or a right arm portion, in accordance with some embodiments of the present invention;

FIG. 19 is a flowchart of a method of dynamically adapting a ventilator for maintain a target air pressure within a region defined by an inner surface of a mask when in use, in accordance with some embodiments of the present invention;

FIG. 20 is a block diagram of a control circuit for dynamically maintaining a target baseline air pressure in a region of the mask, in accordance with some embodiments of the present invention;

FIG. 21 includes schematics depicting an exemplary user interface for setting parameters for dynamic maintenance of the target baseline air pressure in the region of the mask, in accordance with some embodiments of the present invention; FIG. 22 includes graphs of dynamically adjusted blower flow rate over time for maintaining a target baseline air pressure in the region of the mask, in accordance with some embodiments of the present invention; and

FIG. 23 is a schematic of an exemplary scenario of an implementation of a respirator system, in accordance with some embodiments of the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

An aspect of some embodiments of the present invention relates to a respirator system including a mask (sometimes also referred to as respirator mask), which may be worn by ambulatory users (i.e., users that may be walking about as opposed to patients that are immobile or minimally mobile such as in a wheel chair and/or bed) a respiratory system including a mask, methods based on the respirator system, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) for implementing features associated with the mask, that switches between an active mode and a passive mode. During active mode, a ventilator actively delivers an active air flow channel of air to a region between an inner surface of the mask and the face of the person (e.g., including air for inhalation by the user), i.e., the nose, mouth, and portions of the cheeks when the mask is worn correctly. During active mode, the ventilator may actively evacuate air from the region (e.g., including air exhaled by the user). The delivery and/or evacuation of the air may be considered as part of one continuous air flow channel, which may include an air delivery air channel component and an air evacuation channel component. The delivery and/or evaluation of air may be performed by tube(s) connected to aperture(s) located on the mask. When the active air flow channel is interrupted (e.g., ventilator failure, kink in tubing, removal of a connecting tube(s) from the mask), the mask switches from active air flow, where air is delivered and/or evacuated via the aperture(s) of the mask, to passive air flow mode, where air is delivered and/or evacuated (by the user’s inhalation and/or exhalation efforts) by a passive air flow channel established across a filter(s) located within the mask at a location other than the aperture(s), optionally the filter is located in the inner surface of the mask and/or within the mask itself corresponding to the region of the mask where when in use, the user places their nose and/or mouth.

An aspect of some embodiments of the present invention relates to systems, an apparatus, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) for dynamically adjusting a ventilator that delivers air to a region of a mask (formed by the inner surface of the mask when worn by the user) for maintaining a target baseline air pressure in the region that is at a selected pressure above ambient pressure. The ventilator is dynamically adjusted to maintain target baseline air pressure throughout the respiratory cycle, during inspiration, expiration, and/or rest. The ventilator is dynamically adjusted to maintain target baseline air pressure throughout variations in demand for air by the user, for example, variations in activity of the user such as sitting, walking, and running.

An aspect of some embodiments of the present invention relates to systems, an apparatus, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) for dynamically computing when a filter (e.g., in a ventilator) in an active air channel that actively delivers air to a region of a mask (formed by the inner surface of the mask when worn by the user) requires changing, according to an indicator included in the filter that is read by an indicator reader located in the ventilator. The amount of remaining lifetime of the filter (before a new filter is replaced) is estimated according to dynamic pressure changes of the air being delivered to the mask, for example, for maintaining a target baseline air pressure in the region that is at a selected pressure above ambient pressure.

The respirator system described herein may be used by healthy people (e.g., normal functioning lungs and/or may breath sufficiently well on their own without a mask), for example, during work and/or exercise, for example, as described herein in additional detail.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein address the technical problem of user discomfort while wearing masks. Masks are being commonly worn by many people, for example, to protect against spread of viral infections, in particular COVID-19 (e.g., prevent spreading of the viral infection and/or prevent becoming infected with the viral infection), and/or protection from pollution. Examples of such masks include cloth masks, surgical disposable masks, and/or fabric masks with filters (which may be disposable). Such masks are passive, in that the force applied to the air across the mask (e.g., the fabric, cloth, filters) during inspiration and/or expiration is provided by the breathing user. Moreover, such masks, which are made of flexible material, conform to the facial features when worn, and contact most of the face, such as the nose, cheeks, and lips. The breathing by the user into the mask contacting their face may create a situation of discomfort, for example, due to rising temperatures and/or increased humidity and/or sense of difficulty in breathing. As such, many users are unable to wear such masks for extended periods of time, and may occasionally or mostly adjust and/or remove the masks to below the nose and/or mouth in order to obtain relief. The removal and/or adjustment of the mask places the user and/or other people in proximity, at risk of being infected and/or risk of infecting others with the viral disease. Moreover, the mask becomes increasingly uncomfortable to wear during hot temperatures, high humidity, and/or during effort exerted by the user such as during exercise and/or other strenuous activities.

Other available masks are for different purposes, and cannot be used for users that are moving about such as walking and/or running. Such masks are not designed for day-to-day healthy users, but are designed for specific situations in which respiratory assistance is needed. For example, other available masks are made of rigid material (e.g., plastic) that forms a space between the inner surface of the mask and the nose and/or mouth of the user, for example, masks used by air force pilots and/or hospital respiratory masks. Such masks are cannot be used by regular users that are moving about such as walking and/or running, for example, due to their weight, discomfort while being worn due to their large size and/or pressured applied to the face by the outer edges of the mask. Moreover, since air flow is critical to users using such masks, the mask and/or tubing is made of rigid material that maintains its shape in order to avoid kinks and/or other obstructions within the mask and/or tubing.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein address the above mentioned technical problem, and/or improve the technology of masks, by providing an mask that is made of flexible material that conforms to features of the face when worn, that is operable and/or may be dynamically switched between an active mode in which air is forced and/or assisted, into and/or removed from the mask by an air ventilator device, and a passive mode in which the air is forced into and/or removed from the mask by the breathing action of the user. The mask made of flexible material is more comfortable to wear, may be made of different materials, and is compact when not worn. For example, a user on an airplane is sitting in their seat with mask connected to the ventilator that provides air entry and/or evacuation for the mask in the active mode. When the user wishes to go to the bathroom, rather than going with the tubing and ventilator, the user may disconnect the mask from the tubing, which automatically switches from the active mode to the passive mode, by the user now breathing on their own via the filter on the mask without the ventilator. When the user returns, the user may reconnect the mask to the tubing, and switch back from passive mode to active mode. Moreover, the ability to switch between active and passive air flow modes provides a safety measure against kinks and/or obstructions within the tubing and/or against failure of the ventilator (e.g., drained battery, mechanical failure), enabling the tubing to be relatively flexible and/or thinner than would be required for patients where rigid tubing is required (i.e., where air flow to overcome obstruction and/or provide mechanical ventilation is important). For example, when a tube is kinked and/or a ventilator failure occurs, and the active air flow into the mask is obstructed and/or stopped, the user is able to breath in passive mode using another filter of the mask that is in the passive air flow channel, preventing an uncomfortable feeling of suffocation when the active air flow is suddenly disrupted.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein address the technical problem of automatically regulating air flow entering and/or leaving a mask worn by a user. Standard approaches for regulating air flow are designed to deliver air to a user suffering from a respiratory problem, for example, by delivering a target baseline air pressure that is high enough to overcome an obstruction and/or to enter the lungs to delivery sufficient air. For example, to prevent sleep apnea, provide air to lungs when inadequate respiratory action is generated by the user (e.g., difficulty breathing) such as due to injury, airway obstruction such as in chocking victims and/or in mechanical ventilation applications, provide increased amounts of air such as to victims of smoke inhalation and/or drowning. Such high pressures are not needed for healthy users, and may actually cause such users difficulty in their own breathing by interfering with the natural breathing of the user.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein address the above mentioned technical problem, and/or improve the technology of automated control of air delivery to and/or from an mask, by providing a target baseline positive air pressure (i.e., as measured between the inner surface of the mask and the face of the user, relative to ambient air pressure) that is lower than pressure that would be provided to overcome obstructions and/or ventilate patients who have trouble breathing on their own. The target positive air pressure may be set by the user, for example, to obtain a desired comfort level. The target positive air pressure is dynamically maintained during changes in breathing patterns of the user, for example, during increased breathing effort by the user while performing exercise and/or other strenuous activity. The target positive air pressure is dynamically maintained by real time adjustment of a ventilation device that delivers air to the mask and/or removes air from the mask. The target positive air pressure is dynamically maintained during the breathing cycle of the patient, for example, when the patient is exhaling and the pressure in the region between the mask and the face of the user, the ventilator may apply a negative pressure in order to maintain the pressure in the region at the target pressure. The target positive air pressure that is maintained for the region between the inner surface of the mask and the face of the user may provide other advantages, for example, preventing full contact between the mask and the face by the forced air that forces the mask away from the face which may increase comfort such as reducing a feeling of choking, prevent external air from entering the region between the inner surface of the mask and the face of the user such as from above the cheeks and/or though hairs of a beard, provide constant air flow across the face of the user underneath the mask that cools the face and creates a feeling of comfort especially in hot and/or humid weather, and provide a comfortable feeling of breathing during exertion. The target baseline may provide a weak yet constant airflow, which is synchronized with the breathing of the user. The target baseline may improve efficiency of the battery, by reducing overall batter usage by using as much energy as required to maintain the target baseline according to the breathing of the user, rather than by constantly meeting an expected top air demand which would require higher battery usage. The target baseline may improve the user experience in terms of sound generated by the ventilator, by reducing the amount of work done by the ventilator which reduces noise of the ventilator. Higher work of the ventilator resulting in higher noise is dynamically provided based on user need, as described herein. Moreover, by dynamically maintaining the baseline target pressure, the approach is insensitive to leaks. Leakage of air out of the mask is automatically compensated for by the automatic adjustment of the active air flow that maintains the target baseline.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein address the technical problem of replacement of disposable filters in masks. Such filters may have a defined manufacturer lifetime, for example, 20-60 hours. It may be difficult for users to determine when to change the filter in order to maximize protection from infection and/or pollution while avoiding early changes of the filter. For example, a user that performs exercise and/or other strenuous activity while wearing the mask with filter may need to change the filter more often than another user that uses the mask while working at a relaxing desk job. In the described example, both users may end up changing the filter at the same time, which may create a situation when the filter for the user performing strenuous activity is no longer providing protection from infection and/or pollution, while the filter for the user at the relaxing desk job is changed too early.

At least some implementations of the respirator mask, apparatus, systems, methods, and/or code instructions (e.g., stored on a memory and executable by one or more hardware processors) described herein provide a solution to the above mentioned technical problem, and/or improve the technical field of filters for masks, by providing an automated computer implemented approach (e.g., based on machine learning (ML) models) that analyzes airflow across the filter (e.g., manually generated by respiratory action of the user and/or automatically and/or semi- automatically generated by a ventilator such as that maintains a target positive air pressure as described herein) for predicting an amount of time remaining for the filter. Filters that experience more intense air flow (e.g., increased respiratory rate, increased volume during each respiratory cycle, increased pressures) are predicted to require changing at an earlier time in comparison to filters that experience less intense air flow.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

The present invention may be a system, a method, and/or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.

The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

Computer readable program instructions described herein can be downloaded to respective computing/processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and/or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. A network adapter card or network interface in each computing/processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing/processing device.

Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present invention.

Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks.

The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.

The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

Reference is now made to FIG. 1, which is a schematic of a high level block diagram of components of a system 100 for ventilation of a user, in accordance with some embodiments of the present invention. System 100 may provide improved user experience in terms of comfortable breathing while wearing a mask 102, in particular for users without respiratory difficult and/or that do not require respiratory support such as for mechanical ventilation and/or obstruction. Different exemplary implementations of system 100 are described herein, such as different architectures. Additional exemplary details of one or more components of system 100 are described herein, for example, with respect to the other FIGs. 2-23. For example, masks described with reference to other FIGs. 2-23 may be based on mask 102 (e.g., mask 102A and/or 102B) described with reference to FIG. 1, and/or ventilator described with reference to other FIGs. 2-23 may be based on ventilator 116 described with reference to FIG. 1. It is noted that the respirator system described herein may include mask (e.g., 102) ventilator (e.g., 116), tubing (e.g., 114), one or more components thereof (e.g., as described herein), and/or one or more other components (e.g., as described herein).

Masks 102A-B represent exemplary embodiments of mask 102. Mask 102A represents an optional re-useable mask, where components 106, 104, 112A, and 110 may be connected, optionally attached and/or built-in. Mask 102B represents an optional disposable mask that includes one or more build-in exhalation valves 158. The built-in exhalation valves 158 may be removed to create aperture(s) 108 to which tubing 114 is connected, as described herein. Examples of disposable mask 102B include N95, N99, N99, and the like. Mask 102B may include a filter 180 and/or may be referred to as filter 180, for example, where the entire mask itself acts as a filter. Filter 180 may act as a passive filter for the passive air channel, as described herein, for example, with reference to filter 104.

Mask 102 (may also referred to herein as respirator mask) is made of a non-rigid and/or flexible material, for example, cloth, paper based, soft plastic based. Mask 102, when not worn, does not maintain a fixed shape, but succumbs to gravity, for example, lies flat on a flat surface. When worn, mask 102 conforms to facial feature such as the nose, cheeks, lips, and/or chin of the user. When worn, a significant portion of the inner surface of mask 102 contacts the face of the user. Mask 102 may be disposable, or multi-use.

Mask 102 is designed to accommodate one or more filters 104. Filter(s) 104 may be disposable, optionally when mask 102 is multi-use. For example, an existing filter(s) 104 is removed from mask 102, and a new filter(s) 104 is inserted. Alternatively or additionally, filter(s) 104 may be integrated within mask 102, for example, within the material of mask 102 itself. Filter(s)104 may be position within mask 102 for passive mode, for example in front of the nose and/or mouth. Alternatively or additionally, filter(s) 104 may be positioned within mask 102 for active mode, for example, within the air flow channel of actively delivered air into and/or out of mask 102. For example, filter(s) 104 may be positioned within aperture(s) 108 to filter air provided by the active air channel established by ventilator 116 via tubing 114. It is noted that one or more filter(s) 104 may be located in tubing 114. Filter(s) 104 may act as a passive air filter for the passive air channel, and/or an active air filter for the active air channel. There may be two or more filter(s) 104, for example, one in the air flow channel of actively delivered air into mask 102, another in the air flow channel of actively removed air out of mask 102, and/or yet another in the air flow channels during passive breathing. Filter(s) 104 may be in addition to, and/or alternatively to, filter(s) 118 of ventilator 116, which delivers filtered air to the mask via the active air channel, as described herein. Filter(s) 104 and/or filter(s) 118 may be a high quality surface filter, for example, N95, N99, P100, and/or combinations of the aforementioned. Filter(s) may be flat. Filters may include two or more pieces of the same filter type and/or two or more different filter types. The user may change the type of filter to be used N95, N99 or plOO based on availability. For example, two layers of N95 will guarantee filtering factor of about 97.5% according to the following calculation:

100

Optionally, filter(s) 104 is associated with a lifetime indicator element 106 that is analyzed for predicting an amount of remaining time before filter(s) 104 requires changing, as described herein.

Mask 102 may include one or more aperture(s) 108 for entry and/or exit of air, such as during active mode.

Different configurations of aperture(s) 108 include: a single aperture(s) 108 for active entry of air (e.g., serving as an inspiratory port for receiving air actively delivered by the ventilator via the active air channel, where the air is for inspiration by the user), where exit of air is via passive mode, a single aperture(s) 108 for active exit of air (e.g., serving as an exhalation port for actively transporting air out of the region of the mask to the ventilator, where the air has been exhaled by the user), where entry of air is via passive mode, a single aperture(s) 108 for active entry and active exit of air, and two aperture(s) - a first for active entry of air and a second for active exit of air. Filter(s) may be located within the air flow path of aperture(s) 108, for example, within the inner surface of mask 102 covering aperture(s) 108.

Aperture(s) 108 may be associated with closure mechanism 110, that is designed to be open during active mode for air entry and/or exit via aperture(s) 108, and designed to be closed during passive mode to prevent air entry and/or exit via aperture(s) 108. Close mechanism 110 may be a mechanical mechanism that is biased (e.g., via an urging element such as a spring) to automatically close, such as when tubing 114 connected to aperture(s) 108 is removed. The urging force may be set by opening the mechanical mechanism such as when the tube is connected to aperture(s) 108.

Mask 102 may include one or more sensor(s) 112A, for example, pressure sensor(s) for sensing the pressure within a region between the inner surface of mask and the face of the user, in particular, in front of and/or in proximity to the nose, mouth, and/or cheeks. Pressure sensor(s) may sense ambient pressure. Other exemplary sensor(s) 112A include oxygen sensors, carbon dioxide sensors, oxygen saturation sensors, a microphone, and humidity sensor(s). The humidity sensor(s) may sense humidity inside and/or outside the mask. Alternatively or additionally, sensor(s) 112B may be located in other location along the airflow channel, for example, within tubing 114, and/or sensor(s) 112C may be located within a ventilator 116, in which case the pressure within the region between the inner surface of mask and the face of the user may be indirectly measured and/or estimated.

Data from sensor(s) 112A and/or 112B and/or 112C may be transmitted to computing device 120 via a data channel, for example, wire(s) built in to the all of tubing 114 and/or wireless channels (e.g., wireless transmission by a wireless transmitter associated with the sensor(s) that is received by a wireless receiver associated with computing device 120).

Tubing 114 fluidly connects mask 102 to ventilator 116 and/or establishes air channels for air low in active mode. Air may be actively delivered from ventilator 116 to mask 102 via tubing 114, and/or air may be actively removed from mask 102 to ventilator 116 via tubing 114. There may be two tubes, a first for active air delivery from ventilator 116 to mask 102, and a second tube for active air removal from mask 102 to ventilator 116. Alternatively, only one of the first and second tubes is used. There may be a single tube for active air delivery between (i.e., in one or both directions) ventilator 116 and mask 102.

Ventilator 116 may include one or more filters 118, for filtering air being delivered to mask 102 via the active air channel and/or for filtering air being evacuated from mask 102 via the active air channel. Filter 118 may be similar to filter 104. Filter 118 may be associated with lifetime indicator 106, as described herein. In active mode, filter 104 in mask may be fluidly connected to filter 118 in ventilator 116, i.e., the active air channel is via filters 104 and 118.

Ventilator 116 may include a ventilation controller 140, that controllers one or more blowers 142 (e.g., turbine, fan, centrifugal fan) that delivers air to mask 102 and/or evacuates air from mask 102 in active mode, as described herein. System 100 includes a computing device 120. Computing device 120 may be installed within ventilator 116 and/or may be implemented as an external component, for example, code installed on mobile device (e.g., smartphone, tablet, laptop, glasses computer, watch computer), client terminal, virtual machine, and/or server (e.g., network server, computing cloud). Computing device 120 may receive data from pressure sensor(s) 112 and/or ventilation controller 140, lifetime indicator 106, and/or other sensors (e.g., battery power) and generate instructions for adjustment of ventilation controller 140 and/or other instructions, as described herein.

Optionally, a source of supplemental oxygen 150 is connected to ventilator 116, for example, a miniature oxygen tank, a large oxygen tank and/or a wall outlet. Control circuitry 152 may automatically and/or manually control the amount of supplemental oxygen 150 that enters ventilator 116, optionally for mixing with external air suctioned into ventilator 116, for being delivered to mask 102 via the active air channel. The amount of additional supplemental oxygen 150 may be adjusted based on one or more sensor measurements, and/or one or more parameters computed based on sensor measurements. For example, the energy expenditure of the user may be estimated based on oxygen and/or carbon dioxide measurements obtained by the sensors. The amount of supplemental oxygen may be delivered according to the estimated energy expenditure, for example, using a mapping function and/or proportional, and/or other relationship. In yet another example, the amount of additional supplemental oxygen 150 may be adjusted based on the baseline air pressure maintained within the mask (which may be monitored by sensors), as described herein. For example, proportional, using a mapping function, and/or other relationship. For example, higher supplemental oxygen amounts for higher baseline air pressures, since higher baseline pressure may indicate that the user requires more air since the user is hot and/or performing physical activity. In yet another example, when the oxygen saturation sensor (e.g., 112A) of mask 102 detects a reduction in oxygen saturation below 92% (or other threshold and/or range), supplemental oxygen may be delivered to increase and/or maintain the oxygen saturation above 92%. In another example, an oxygen sensor senses the percentage of oxygen delivered to the user and/or exhaled by the user. The supplemental oxygen may be added to obtain and/or maintain the percentage of oxygen delivered to the user and/or exhaled by the user above a target threshold and/or within a target range.

It is noted that control circuitry 152 may be referred to herein as a controller. Control circuitry 152 may be alternatively and/or additionally implemented as code 124A stored on memory 124 executed by computing device 120 (which may also be referred to herein as controller).

Ventilator 116 may include one or more manual interfaces 154 for manual data entry. Manual interface(s) 154 may be located on the surface of a housing (e.g., box) of ventilator 116. Manual interface(s) 154 may be, for example, a dial(s), a button(s), and the like. Manual interface 154 may be used, for example, to manually adjust the target baseline air pressure for the region defined by the inner surface of the mask when worn by the user, for example, to increase and/or decrease the value of the target baseline air pressure that is maintained, as described herein.

It is noted that one or more components show within a certain component may be located externally to that component, in communication with that component. For example, filter 104 may be integrated within mask 102A, or detachable. In another example, sensor(s) 112A may be external to mask 102A. Alternatively or additionally, one or more components located externally may be integrated and/or located within another component. For example, power source 170 may be batteries installed within ventilator 116.

Hardware processor(s) 122 of computing device 120 may be implemented, for example, as a central processing unit(s) (CPU), a graphics processing unit(s) (GPU), field programmable gate array(s) (FPGA), digital signal processor(s) (DSP), and application specific integrated circuit(s) (ASIC). Processor(s) 122 may include a single processor, or multiple processors (homogenous or heterogeneous) arranged for parallel processing, as clusters and/or as one or more multi core processing devices.

Storage device (e.g., memory) 124 stores code instructions executable by hardware processor(s) 122, for example, a random access memory (RAM), read-only memory (ROM), and/or a storage device, for example, non-volatile memory, magnetic media, semiconductor memory devices, hard drive, removable storage, and optical media (e.g., DVD, CD-ROM). Memory 124 stores code 124 A that implements one or more features and/or acts of the methods described herein when executed by hardware processor(s) 122.

Computing device 120 may include data repository (e.g., storage device(s)) 126 for storing data, for example, historical pressure measurements which may be analyzed, as described herein. Data storage device(s) 126 may be implemented as, for example, a memory, a local hard-drive, virtual storage, a removable storage unit, an optical disk, a storage device, and/or as a remote server and/or computing cloud (e.g., accessed using a network connection).

Computing device 120 may include a network interface 128 for connecting to a network 130, for example, one or more of, a network interface card, an antenna, a wireless interface to connect to a wireless network, a physical interface for connecting to a cable for network connectivity, a virtual interface implemented in software, network communication software providing higher layers of network connectivity, and/or other implementations.

Network 130 may be implemented as, for example, the internet, a local area network, a virtual network, a wireless network, a cellular network, a local bus, a point to point link (e.g., wired), and/or combinations of the aforementioned.

Computing device 120 may communicate over network 130, for example, with a client terminal(s) 132 and/or server(s) 134. Client terminal 132 may be of the user wearing mask 102, for example, for remotely controlling and/or monitoring parameters of ventilator 116, as described herein. Server(s) 134 may include, for example, a data server storing updated code for installation on computing device 120, and/or data collected by computing device 120 may be sent to server(s) 134 for further analysis such as to improve automated active mode processes. Server(s) 134 and/or client terminal(s) 132 may be implemented as, for example, a client terminal, a server, a virtual server, a virtual machine, a computing cloud, a mobile device, a desktop computer, a thin client, a Smartphone, a Tablet computer, a laptop computer, a wearable computer, glasses computer, and a watch computer.

Computing device 120 may include and/or be in communication with one or more physical user interfaces 136 that include a mechanism for user interaction, for example, to enter data (e.g., select the target positive target air pressure) and/or to view data (e.g., remaining amount of time before the filter is to be changed). Alternatively or additionally, user interface 136 is incorporated into a housing of ventilator 116, for example, as a touch screen, as a display, as one or more control buttons, and/or as status indicator lights (e.g., indicating active or passive mode, set baseline pressure, and the like).

Exemplary physical user interfaces 136 include, for example, one or more of, a touchscreen, a display, gesture activation devices, a keyboard, a mouse, and voice activated software using speakers and microphone. Optionally, client terminal 132 serves as user interface 136, for example, an application loaded on a smartphone that is accessed by the touchscreen of the smartphone.

User interface 136 may be used to access a dashboard application, which may be locally stored on client terminal 132 and/or memory 124 and/or data repository 126, and/or remotely stored on server(s) 134. The dashboard application may display historical data, for example, parameters of usage of the mask, selected baseline target pressure, ability to maintain the selected baseline target pressure, amount of time remaining for change of filter, and the like.

One or more components of system 100 are powered by one or more power sources, for example, an internal battery pack (e.g., rechargeable) and/or an external pack connected by cable, for example, connectable to an electrical outlet, connected to a USB port (e.g., in a car and/or plane), and/or connectable to other standard power sources (e.g., smartphone charging stations).

Reference is now made to FIG. 2, which includes schematics 200A-C depicting a baseline mask 202 with an exhalation valve 204 that is adapted for active air flow, in accordance with some embodiments of the present invention.

Schematic 200A depicts baseline mask 202, which is optionally a low cost and/or based on an available mask intended to provide comfortable and/or filtered air, which may be microorganism free (e.g., virus, COVID-19 virus, bacteria, protozoa, flies), and/or provides protective breathing (e.g., protection against pollution). For example, mask 202 is based on a standard surgical mask and/or cloth mask that is commonly worn by people, for example, during a viral disease outbreak such as COVID-19. Mask 202 may include a filter 204 designed for transfer of air across filter 204 in response to a user’s inhalation and/or exhalation respiratory actions.

Mask 202 includes an exhalation valve 250, where during increased pressure in the region formed by the inner surface of mask 202 and the face of the user (i.e., when mask 202 is worn correctly by the user, covering the nose and mouth), such as during exhalation by the user, air is evacuated from the region by exhalation valve 250. Exhalation valve 250 may be one way, to allow evacuation of air from the inner surface of mask 202 to the external environment and not allow air to enter the inner surface of the mask 202 from the external environment. Inhalation may be across filter 204. It is noted that in some environments, exhalation valve 250 is prohibited from being used, for example, to reduce risk of the user spreading contaminated air to the environment such as when the user is infected with a viral disease and the exhaled air contains the vims.

Schematic 200B depicts removal of exhalation valve 250, to create an aperture 208, for establishment of the active air channel during active mode, as described herein.

Schematic 200C depicts attachment of a tube 214 (e.g., an elbow tube designed to connected to a long tube, and/or the whole tube itself) to aperture 208. The active air flow channel, for active delivery and/or evacuation of air by the ventilator as described herein, is established via tube 214 connected to aperture 208.

Aperture 208 may be positioned towards the edge regions of mask 202 (at the wide portion designed to contact the face region of the nose and mouth), so that in use, aperture 208 is located away from the nose and/or mouth of the user. Such a design enables the passive channel to be more easily established across filter 204 by placing filter 204 in proximity to the nose and/or mouth making it easier to breath across filter 204, while the active channel is established in the more remotely located aperture 208 since the air flow is actively delivered, overcoming resistance by the relative small sized aperture 208.

Reference is now made to FIG. 3A, which is a schematic depicting, from a side view, mask 202 connected to a ventilator 216 via a connecting flexible tube 214 and via aperture 208 of mask 202, for establishment of the active air channel and/or dynamic adaptation of pressure, in accordance with some embodiments of the present invention.

Ventilator may sometimes be referred to herein as “respirator blower”.

Ventilator 216 forces (i.e., actively) air (optionally filtered by a filter located within ventilator) into mask 202 and/or actively evacuates air from mask 202 via tube 214 and aperture 202, optionally to maintain air pressure and/or dynamically adjust the air pressure within the region formed by the inner surface of mask 202 and portion of the face of the user including the nose and/or mouth when mask 202 is worn correctly, as described herein. Ventilator 216 provides active controlled (e.g., dynamically adapted) feeding of above atmosphere filtered air to mask 202 for maintaining a controllable over atmospheric pressure (e.g., a target pressure) inside the inner surface of mask 202 placed in proximity to the nose and/or mouth of the user. The target pressure may be selected for making breathing more comfortable to the user, as described herein. The filtered air is delivered to the mask from ventilator 216 tube 214 connected on one end to the ventilator 216 and on the other end to aperture 208, optionally following removal of exhalation valve 250. The connection is optionally performed, for example, by a bayonet or latch type coupler.

When exhaling, a pressure activated controller reduces the forced airflow by ventilator 116 so as to reduce the back pressure resistance to the exhaling user, as described herein.

Ventilator 216 may be housed in an external housing, for example, shaped like a box. The housing may include a clip, for example, for clipping onto a belt, backpack, shirt, purse, and/or other worn item.

Ventilator 216 may include a suction grill 260 through which air is suctioned into ventilator 216 from the external environment, and/or through which air is evacuated to the external environment. Grill 260 may be opened to replace a filter located within ventilator 216.

Reference is now made to FIG. 3B, which is a schematic depicting, from a back view, the mask connected to the ventilator for establishment of the active air channel and/or dynamic adaptation of pressure of FIG. 3 A, in accordance with some embodiments of the present invention. The schematic of FIG. 3B depicts a view of mask 202 as seen by the user just prior to putting on mask 202. The schematic of FIG. 3B depicts an inner surface 370 of mask 202, which is placed against a face region of the user that includes the mouth and/or nose.

As shown, mask 202 includes a cover mask portion 372, which may be reusable. Cover mask portion 372 may be made of a flexible, compliant, non-rigid, material that is porous to air, that conforms to the facial features of the user when worn. Optionally, filter 204 is replaceable and/or disposable.

Optionally, cover mask 372 includes a central wide portion 374 that is selected to have a width for covering a nose and a mouth of a user when the mask is worn. A left arm 376A and a right arm 376B extend from central wide portion 374, for example, by tapering from central wide portion 374. Width of left arm 376 A and right arm 376B may be smaller than width of central wide portion 374, for example, about 0.1 to 3 centimeters, or other values. In use, end portions of arms 376A-B connect to one another for securing mask 202 on the face of the user, for example, using Velcro and/or scotch stipes 378, and/or by tying. Replaceable filter 204 may be connected to wide central portion 374. No filter is necessarily connected to arms 376A-B. Ventilator establishes the active air channel, which includes the following: air suction 380 into ventilator 216, filtered air is forced out 382 from ventilator 216 into tube 214, filtered air enters 384 via aperture 208A the inner surface 370 which is positioned against the face (i.e., nose and mouth) of the user during use, the air is inhaled by the user. During exhalation, when aperture 208B is blocked by the closing mechanism, the exhaled air may be passively evacuated 386 by a passive air channel across filter 204. Alternatively, during exhalation, when aperture 208B is opened and attached to another tube for active evacuation by the ventilator, the active air channel includes air existing 388 the aperture 208B, as described herein in additional detail.

Reference is now made to FIG. 3C, which is a schematic depicting mask 202 with an optional oxygen sensor(s) 270 and/or an optional oxygen saturation sensor(s) 272, in accordance with some embodiments of the present invention. Oxygen sensor(s) 270 may be located on a portion of tubing 214 that connects to the ventilator, for example, an elbow shaped tubing connected to mask 202. Oxygen sensor(s) 270 may measure the amount of oxygen actively delivered to the region of the mask of the user in the active air channel and/or oxygen removed from the mask of the user during active removal, as described herein. Oxygen saturation sensors may be connected to mask 272, for example, as clip-ons and/or integrated therein. For example, a nasal oxygen saturation sensor built in to nose clips of the mask that adjust against the contour of the nose, and/or ear oxygen saturation sensors built in to elongated arms of the mask that are designed to extend along the side of the face towards the back of the head for securing the mask against the face. The ear oxygen saturation sensor(s) may be located along the elongated arms at a position so that when the mask is worn the ear oxygen saturation sensor(s) is positioned in contact with the ear for sensing oxygen saturation at the ear. The measurements obtained by oxygen sensor(s) 270 and/or oxygen saturation sensor(s) 272 may be used to adjust the ventilator, optionally the amount of supplemental oxygen delivered to the region of the mask, optionally to maintain a target measurement value, for example, as described herein. It is noted that an external oxygen saturation sensor may be used as an alternative to, or in addition to oxygen saturation sensor(s) 272 on the mask, for example, a sensor designed to be placed on a finger of the user.

Reference is now made to FIG. 4, which is a schematic of an exemplary implementation of a ventilator 416 that establishes an active air channel and/or optionally dynamically adjusts the active air delivery to maintain a target air pressure in a region established by the inner surface of mask when in use, in accordance with some embodiments of the present invention.

Ventilator 416 may include one or more of the following components: An air inlet grill 450 serving as an inlet port for enabling air flow from an external environment into ventilator 416 (and to the mask) and/or for air flow from ventilator 416 (evacuated from the mask) to the external environment.

A removable cover 452 for exposing filter(s) 418 for replacement thereof. Inlet port 450 may be part of cover 452.

Cover 452 and/or grill 450 and/or filter(s) 418 may be located on both opposing sides of ventilator 416, or alternatively on one side of ventilator 416.

Filter(s) 418 may include a frame (e.g., made from plastic and/or metal) forming a replaceable cassette. Filter(s) 418 may include an indicator for alerting a user when filter(s) 418 requiring changing, for example, due to elapsed time and/or large pressure drop indicating clogging, for example, via a communication port 456 (e.g., wireless Bluetooth connecting to a smartphone implementation of the computing device and/or user interface, as described herein). The remaining lifetime of filter(s) 418 may be dynamically computed according to the dynamic adjustments of the active air channel and/or indication of pressure drop across filer(s) 418 (e.g., as measured by a pressure sensor), as described herein.

Optionally, filter 418 is placed behind inlet grill 450 (i.e., ahead of blower 458) and/or before air exhausted from the air outlet 454 (i.e., after blower 458), relative to the air flow channel that delivers air to the mask, which protects blower 458 from coming in contact with contaminated air, maintaining blower 458 in a sterile state.

The following is an exemplary filter replacement process:

^¨ _¨ ^¨ Pull out cover 452 having air inlet grill (e.g., screen) 450, they are assumed to be contaminated.

^¨ _¨ ^¨ Pull out the used filter 418 (e.g., contaminated on outer side).

^¨ _¨ ^¨ With sterile hands place a new sterile filter 418 in place.

^¨ _¨ ^¨ Close cover 452.

Optionally, cover 452 may be part of the cassette filter assembly 418 (e.g., forming one of the frames). In such implementation one replacement on each side of ventilator 416 may be needed.

An air outlet 454 that is connected to a tube which is connected to one or more aperture(s) for mask, for establishment of the active air flow channel.

A blower 458, for example, a centrifugal blower and/or axial fan, that generates positive pressure for delivery of air to the mask and/or suction pressure (i.e., negative pressure) for evacuation of air from the mask. Two fans of different types may be used, for example, tandem motor and fan. Control circuit, pressure sensors, charging and/or communication components 462, as described herein.

Charging and/or communication port 456 (e.g., USB, wireless port) for connection to a computing device which may control blower and/or provide an interface, as described herein.

A battery pack 460, optionally rechargeable, for providing electrical power to blower 458 and/or circuitry and/or sensors and/or other components, as described herein.

Life of battery 460 may be optimized by the dynamic adaption of ventilator 416 to maintain the target air pressure within the inner surface of mask (when in use), as described herein.

The following are exemplary power considerations, based on example assumptions: flow rate denoted Q of 60 liters per minute [L/min] = 10^L-3 m^A3/sec]

Pressure drop denoted Dr of 10 centimeters of water [cmH20] = lOOOPa Fan efficiency denoted h = 1/3 Power equation:

P = [watt]

A Li- ion battery (e.g., similar to battery used in a cordless drill) has the capacity of 16.2 W-Hr and will last more than 2.5 hours (e.g., for both fans) on a single charge.

Such battery pack may have a size smaller than a cigarette pack. The operation length may improve with better battery technology and more efficient blowers.

Reference is now made to FIG. 5, which is a block diagram of exemplary electronic components 500 in a respirator system, in accordance with some embodiments of the present invention.

Components 500 may be part of a control device 502, which may be implemented in the ventilator and/or computing device described herein. It is noted that components 500 described herein are not necessarily limiting and example, and other implementations of components 500 may be used. Components 500 include one or more of:

Fan interface (e.g., two) for an optional brushless direct current (BLDC) driver 550 that controls the blower(s).

RFID interface 552 (e.g., two), for example, an external antenna, for sensing the indicator on the filter for estimating remaining lifetime of the filter, as described herein.

ESP32 motor control unit (MCU) with blue tooth (BT) and/or wireless connection (Wi-Fi) 554, for example, for controlling the blower(s).

Red green blue (RGB) light emitting diode (LED) display 556, for example, presenting data and/or serving as a user interface. Ambient pressure sensor(s) 558 for sensing the ambient pressure and/or mask pressure sensor interface 560 for sensing pressure of the active air channel for estimating the air pressure within the region formed by the inner surface of the mask when worn by the user, used to generate instructions for dynamic adjustment of the blowers (to adjust the active air channel) to maintain the target pressure in the region formed by the inner surface of the mask, as described herein.

An input USB-C PD controller 20V set point 562 for charging a COTS 5-20V 65W USB- PD type-C powerpack battery 564.

Reference is now made to FIG. 6, which is a schematic of a mask 602 for which an active air channel is established for insertion of air and evacuation of air, in accordance with some embodiments of the present invention. Optionally, the active air channel includes an active air entry component, where a first blower actively forces air into the mask, and an active air evacuation component, where a second blower actively removed air from the mask. The active air entry component and the active air evacuation component may be independently controlled by control of their respective blowers, for example, to maintain a target air pressure within the region created by the inner surface of the mask when worn by the user, as described herein.

Mask 602 includes an entry aperture 608A connected to an entry tube 614A connected to a suction portion 616A of a ventilator 616. Entry aperture 608A is optionally associated with an entry closure mechanism that automatically closes entry aperture 608A when entry tube 614A is disconnected. An exhaust aperture 608B of mask 602 is connected to an exhaust tube 614B connected to an air exhaust portion 616B of ventilator 616. Exhaust aperture 608B is optionally associated with an exhaust closure mechanism that automatically closes exhaust aperture 608B when exhaust tube 614B is disconnected.

An active air flow channel 650 generated by ventilator 616 includes air flowing from suction portion 616A, through entry tube 614A, via entry aperture 608 A into the region defined by the inner surface of mask 602, for breathing in by the user. Air exhaled by the user exists the region defined by the inner surface of mask 602, via evacuation aperture 608B, into evacuation tube 614B and out via evacuation portion 616B of ventilator 616.

A passive air channel is established across filter 604 when the active air channel is terminated, as described herein.

Reference is now made to FIG. 7, which is a flowchart depicting an exemplary flow for switching between an active air channel and a passive air channel in the respirator system, in accordance with some embodiments of the present invention.

At 702, the respirator system operates using the active air channel established by the ventilator for the mask. Optionally, the active air channel may include air flow (e.g. filtered) delivered into the region defined by the inner surface of the mask by the ventilator, via an entry aperture. When there are two apertures, the second evacuation aperture may be closed, optionally by the evacuation closure mechanism associated with the evacuation aperture. The user breathes in the actively delivered air. Air, including air that has been exhaled by the user, is passively evacuated from the region defined by the inner surface of the mask by establishing a passive air channel across the filter of the mask located within the inner surface of the mask.

Alternatively, air is actively evacuated from the region defined by the inner surface of the mask by the ventilator. When there are two apertures, the evacuation aperture through which the air is actively evacuated is connected to a tube connected to the ventilator.

At 704, the active air channel (i.e., portion of the active air channel that delivers air into the region defined by the inner surface of the mask) is disrupted, for example, due to the ventilator malfunctioning, battery power running out, kink in the tube, and/or the ventilator being unavailable (e.g., disconnected).

At 706, the tube is disconnected from the entry aperture. An entry closure mechanism associated with the entry aperture may automatically close the entry aperture.

At 708, a passive air channel is established across the filter. Since both apertures are closed, air inhaled and/or exhaled by the user followed the passive air channel across the filter.

At 710, when the ventilator is restored, the active air channel may be restored by reconnecting the entry tube to the entry aperture of the mask. The passive air channel is terminated by the active air channel.

At 712, 702-710 are iterated.

Reference is now made to FIG. 8, which is an exemplary architecture of a ventilator 816 including an air entry portion 816A for active delivery of air to the mask, and a separate air exhalation portion 816B for active evacuation of air from the mask, in accordance with some embodiments of the present invention. Air entry portion 816A and air exhalation portion 816B are located with a common single enclosure, and are hermetically separated from each other, to prevent air flow between them, for reducing risk of contamination. Air entry portion 816A may include an air entry blower 842 A (also referred to as inlet fan), and air exhalation portion 816B may include an air exhalation blower 842B (also referred to as outlet exhaled air fan). Air entry blower 842 A and air exhalation blower 816B may be independently controlled by a controller to achieve a synergistic effect in establishing the active air channel, and/or may be independently dynamically adapted to maintain the target air pressure within the region defined by the inner surface of mask during use, as described herein. The design of ventilator 816 provides a compact and portable device that establishes an active air channel with a mask, and/or dynamically maintains the air pressure provided at the mask at a target pressure, as described herein.

Air entry portion 816A includes a screen 850 forming a fresh air inlet 851 for entry of air from an external environment. Screen 850 may be part of a removable cover 852 for accessing a filter 814 for replacement thereof. Air entry portion 816A includes air entry blower 842 A, which forces air into an air entry chamber 862A containing a pressure sensor 812 for estimating the pressure of the air at the mask, for computing instructions for adapting a controller of air entry blower 842A for maintaining the air at the target pressure, as described herein. Chamber 862A is connected to an air entry port 864 A connected to a tube leading to the mask, for providing filtered air to the mask by the established active air channel.

Air exhalation portion 816B includes an air evacuation port 864B that receives air actively evacuated from the mask by the active air channel. Air evacuation port 864B leads into an air evacuation chamber 862B connected to an air exhalation blower 842B that evacuates the air received from the mask to the external environment via an air outlet 870.

A barrier 882 separate portions 862A and 862B. Barrier 882 may be arranged diagonally across ventilator 816, creating a larger air entry chamber 862 A where air flow delivered to the mask is substantially along a straight axis formed by the arrangement of ports 851 and 9864A along a straight axis, for reducing resistance of the air flow therethough, which reduces the power provided to blower 842A. Chamber 862B may be smaller and/or include a curved and/or angled air flow channel (e.g., about 90 degree turn) formed by the arrangement of ports 864B and 870 along an axis with an angle and/or curve, which provides the increased room and/or straight air flow for the air entry portion of the air channel that includes air evacuated from the mask. Since the air is being evacuated into the external environment, and may follow a downward pressure differential path between the higher pressure at the mask and the lower pressure of the external environment, the higher resistance of chamber 862B may not necessarily translate into higher power requirement for blower 842B.

Reference is now made to FIG. 9A, which is an exemplary architecture of another ventilator 916 including an air entry portion 916A for active delivery of air to the mask, and a separate air exhalation portion 916B for active evacuation of air from the mask, in accordance with some embodiments of the present invention. Air entry portion 916A and air exhalation portion 916B are located with a common single enclosure, and are hermetically separated from each other, to prevent air flow between them, for reducing risk of contamination. Air entry portion 916A may include an air entry blower 942 A (also referred to as inlet fan), and air exhalation portion 916B may include an air exhalation blower 942B (also referred to as outlet exhaled air fan). Air entry blower 942 A and air exhalation blower 916B may be independently controlled by a controller to achieve a synergistic effect in establishing the active air channel, and/or may be independently dynamically adapted to maintain the target air pressure within the region defined by the inner surface of mask during use, as described herein.

The design of ventilator 916 provides a compact and portable device that establishes an active air channel with a mask, and/or dynamically maintains the air pressure provided at the mask at a target pressure, as described herein.

Air entry portion 916A includes a cover with screen 950A forming a fresh air inlet 951A for entry of air from an external environment. Cover with screen 950A may be removable for accessing an air entry filter 914A for replacement thereof.

Air evacuation portion 916B includes a cover with screen 950B forming an exhaled air outlet 95 IB for evacuation of air to the external environment. Cover with screen 950B may be removable for accessing an air entry filter 914B for replacement thereof.

Air entry portion 916A includes air entry blower 942 A, which forces air into an air entry chamber 962A containing a pressure sensor 912 for estimating the pressure of the air at the mask, for computing instructions for adapting a controller of air entry blower 942A for maintaining the air at the target pressure, as described herein. Chamber 962A is connected to an air entry port 964A connected to a tube leading to the mask, for providing filtered air to the mask by the established active air channel.

Air exhalation portion 916B includes an air evacuation port 964B that receives air actively evacuated from the mask by the active air channel. Air evacuation port 964B leads into an air evacuation chamber 962B connected to an air exhalation blower 942B that evacuates the air received from the mask to the external environment via an air outlet 95 IB.

A barrier 982 separate portions 962A and 962B. Barrier 982 may be arranged parallel to a long or short axis of ventilator 916, creating a substantially equally sized air entry chambers 962A and 962B. Air flow delivered to the mask and/or received from the mask may be directed along a curve and/or angle formed between ports 951 A and 964 A, and ports 964B and 95 IB. Ports 964 A and 964B are located side by side along the housing of ventilator 916, making it easier to connect the two tubes. Air flow appears to flow into port 951 A and out port 95 IB arranged along a straight axis, making it more comfortable to wear ventilator 916, since the air flow may be, for example, across the body of the user wearing ventilator 916. Barrier 982 is positioned perpendicular to the straight axis. Reference is now made to FIG. 9B, which is a schematic of an exemplary inlet into a ventilator 970 that includes an inlet matching element 972, in accordance with some embodiments of the present invention. Inlet matching element 972 (also referred to as flow matching diffuser) includes a first inlet 972A having a larger size, substantially corresponding to dimensions of an inlet filter 974 of ventilator, and a second inlet 972B having a smaller size substantially corresponding to dimensions of a ventilator inlet 976 of a blower 978 of the ventilator 970. Inlet matching element 972 includes tapered surfaces between inlets 972 A and 972B, for example, cone shaped and/or pyramid shaped. When the active airflow channel is established by ventilator 970 (as described herein) air from the environment is suctioned 980 substantially across the full surface of filter 974, travels via the tapered (e.g., cone, pyramid) shape of the matching element 972, enters ventilator inlet 976, and is forced out a ventilator outlet 982 to be provided to the region of the mask, as described herein. Inlet matching element 972 increases the life of filter 974 and/or the utilization of filter 974 by enabling air to enter across substantially the entire surface area of filter 974 even when ventilator inlet 976 is small. The small size of ventilator inlet 976 may enable increasing the force of the expelled air at ventilator outlet 982.

Reference is now made to FIG. 10, which is a schematic including a top view 1000A and a side view 1000B of a replaceable filter 1014, including a support frame 1050, and an indicator 1052 for estimating an amount of remaining time before filter 1014 is to be replaced, in accordance with some embodiments of the present invention. Frame 1050 may be made of, for example, a polymer, cardboard, and/or metal. Frame 1050 may be created, for example, from two glued coupled portions (e.g., glued, welded, crimped), and/or from a single injection molded frame. Indicator 1052 may be implemented as, for example, an RFID chip, a QR code, a magnet, mechanical elements (e.g., mechanical switches, for example, each set to a first or a second position) and/or color code. Indicator 1052 may include a code, for example, indicating a lifetime number of hours for filter 1014 when used at a defined baseline.

Reference is now made to FIG. 11, which is a schematic depicting a disposable and/or replaceable filter 1114 with an indicator 1152 located within a ventilator 1116 that includes an indicator reader element 1160 designed to read the code of indicator 1152, in accordance with some embodiments of the present invention. Ventilator 1116 is shown with a screen 1154 in an open position. Optionally, screen 1154 includes a flexible frame 1162 that changes size, enabling accommodating a variety of sizes of filter 1114.

Reference is now made to FIG. 12, which is a schematic depicting separate components illustrating a process of replacing a disposable and/or replaceable filter 1214 (optionally including an indicator 1260 encoding a code that is read by an indicator reading element 1252) within a cover with screen 1254 of a ventilator 1216, in accordance with some embodiments of the present invention. Filter 1214 is depicted as being replaced within an air entry portion 1216A of ventilator where cover 1254 has been removed. Air exit portion 1216B is shown as assembled, after the filter has been replaced and the cover restored.

Reference is now made to FIG. 13, which is a schematic depicting a smartphone 1302 connected to the ventilator and/or computing device, used as an interface thereof, in accordance with some embodiments of the present invention. Smartphone 1302 may be used, for example, to select the target air pressure within the region defined by the inner surface of the mask, display estimated amount of time remaining until the filter is to be changed, amount of battery life, and/or other parameter, as described herein.

Reference is now made to FIG. 14, which is a schematic depicting an example of a closure mechanism 1410 of a mask 1402 that automatically closes an aperture 1408A when a tube is disconnected, in accordance with some embodiments of the present invention. Mask 1402 may include a second aperture 1408B shown in the closed position, optionally automatically closed by another closure mechanism (not shown).

At 1400A, leaflets 1450A-B of closure mechanism 1410 are shown in the closed state that blocks and/or closes the aperture. Leaflets 1450A-B may be set on a hinge 1454, for rotation on hinge 1454. A tension element 1452, for example, a spring, and/or biased hinge, is associated with leaflets 1450A-B.

At 1400B, a tube 1414 is inserted into the aperture. Leaflets 1450A-B change orientation, moving from the closed state to the open state, by rotation on hinge 1454, to enable tube to be inserted into the aperture. The change in orientation of leaflets 1450A-B stores tension in tension element 1452, for example the spring is compressed and/or expanded.

At 1400C, tension applied by tension element 1452 to leaflets 1450A-B secures tube 1414 in the aperture, for example, an urging force applied by the spring.

When the tube is removed from the aperture, the tension stored by tension element 1452 is applied to leaflets 1450A-B, urging leaflets to change orientation from the open state back to the closed state, by rotating back on hinge 1454 in the opposite direction, to reach the state as depicted in 1400A. Leaflets 1450A-B remain in the closed state by the urging force applied by tension element 1452.

Reference is now made to FIG. 15, which is a schematic depicting another example of a closure mechanism 1510 of a mask that automatically closes an aperture 1508 when a tube is disconnected, in accordance with some embodiments of the present invention. Schematic 1500A depicts leaflets 1550A-B of closure mechanism 1510 are shown in the closed state that blocks and/or closes the aperture. Leaflets 1550A-B may be set on hinges 1554A- B, optionally connected to a rotatable ring 1560. A tension elements 1552A-B, for example, springs, are associated with leaflets 1550A-B, hinges 1554A-B, and/or ring 1560.

Schematic 1500B depicts leaflets 1550A-B of closure mechanism 1510 in the open state, to allow a tube to be connected to the aperture. The open state is obtained by rotation 1570 of a ring 1560, which stores tension in springs (i.e., tension elements) 1552A-B, and rotates leaflets 1550

A-B on respective hinges 1554A-B.

Tension applied by springs 1552A-B to leaflets 1550A-B may secure a tube connected to the aperture.

When the tube is removed from the aperture, the tension stored by springs 1552A-B is applied to leaflets 1550A-B and/or ring 1560, urging leaflets 1550A-B to change orientation from the open state back to the closed state, by rotating back on hinges 1554A-B in the opposite direction, to reach the state as depicted in 1500A. Leaflets 1550A-B remain in the closed state by the urging force applied by springs 1452A-B.

Reference is now made to FIG. 16, which is a schematic of a cross section of a ventilator 1616, depicting a tube 1614 attached to a port 1650 of ventilator 1616, in accordance with some embodiments of the present invention.

Reference is now made to FIG. 17, which is a schematic of a mask 1702 including a portion of a tube 1754A (also referred to herein as conformal air duct) positioned along (e.g., substantially parallel to) along a long axis of left arm portion 1752A and/or a right arm portion 1752B (also referred to herein a side strips), in accordance with some embodiments of the present invention. Positioning tube 1754A along the length of portion 1752A and/or 1754B provides a compact device that may increase patient comfort and/or may reduce risk of a disconnection of tube 1754A from the aperture of the mask, and/or enables the remaining length of tube 1754A (i.e., connected tube 1754B) to be freely movable, for example, positioned behind the neck and/or along the back, such as when ventilator 1716 is positioned on the side and/or the back of the user.

Mask 1702 may include a wide central portion 1758 to which a passive filter 1704 (used when the passive air channel is established) is connected. Left arm portion and right arm portion 1752A-B extend from wide central portion 1758. Left arm portion and/or the right arm portion 1752A-B are located in proximity to respective apertures 1708A-B, for example, the aperture is located approximately at the boundary between the left and/or right arm portion and the wide central portion, and/or located at the proximal end of the left and/or right arm portion. Mask 1702 includes a tube connector 1760 for connecting and positioning at least a portion of tube 1754A along a long axis of the respective left arm portion and/or right arm portion 1752A- B, while the mask is in use and while tube 1754A is connected to the respective aperture 1752A and to the ventilator 1716.

Tube connector 1760 may be implemented as, for example, strips, rings, clips, and/or

Velcro.

Tube connector 1760 may be integrated with mask 1702, and/or a separate component attachable and detachable from mask.

Tube connector 1760 may be a tunnel formed by an inner surface of the left arm portion and/or the right arm portion 1752A-B, where the tunnel is sized for including the portion of the tube 1754A encapsulated by the inner surface. For example, tube 1754A in integrated and/or fixed within the tunnel, and/or tube 1754A may be threaded through the tunnel.

Optionally, a connector 1770 at the distal end of tube 1754A is set for detachably connecting to a second tube 1754B that connected to ventilator 1716. Connector 1770 may be set for maximizing user comfort, for example, to enable the user to plug-in and detach from tube 1754B connected to ventilator 1716 as desired. Tube 1754B may be non-connected to mask 1702 other than at connector 1770, for example, freely movable according to a position of ventilator 1716.

Reference is now made to FIG. 18, which is a schematic of another implementation of a mask 1802 including a portion of a tube 1854A (also referred to herein as conformal air duct) positioned along (e.g., substantially parallel to) along a long axis of left arm portion 1852A and/or a right arm portion 1852B (also referred to herein a side strips), in accordance with some embodiments of the present invention.

Mask 1802 may include a wide central portion 1858 to which a passive filter 1804 (used when the passive air channel is established) is connected. Left arm portion and right arm portion 1852A-B extend from wide central portion 1858. Left arm portion and/or the right arm portion 1852A-B are located in proximity to respective apertures.

Mask 1802 includes a tube connector for connecting and positioning at least a portion of tube 1854A along a long axis of the respective left arm portion and/or right arm portion 1852A-B, while the mask is in use and while tube 1854A is connected to the respective aperture 1852A and to the ventilator. In the depicted example, tube connector is implemented as multiple straps 1860 that are spaced apart and located along a length of the respective portion 1852A-B.

A cross section of the portion of the tube 1854A along the long axis includes a straight portion 1870 that contacts the left arm portion and/or the right arm portion and a curved arc shaped portion 1872 connected to the straight portion. Curved arc shaped portion 1872 does not contact the left arm portion and/or the right arm portion. Another tube 1854B (leading to the ventilator) connected to a distal end of tube 1854A may have a similar cross section, and/or a circular cross section. A suitable connector may connect between the tubes with different (or similar) cross sectional shapes.

Optionally, an elbow connector 1880 connects between an aperture of mask 1802 and tube 1854A. Elbow connector 1880 has a curve angle selected to connect between the aperture and the portion of the tube 1854A located along the long axis of arm portions 1852A-B, for example about 90 degrees, or about 60 - 120 degrees, or other values. Elbow connector 1880 may be set for connecting to the aperture of the mask and/or for adjustable rotation relative to the aperture, and/or for detaching from the connection to the aperture of the mask by rotation and pulling of elbow connector 1880. Alternatively, elbow connector 1880 is fixed in location with respective to the aperture.

Reference is now made to FIG. 19, which is a flowchart of a method of dynamically adapting a ventilator for maintain a target air pressure within a region defined by an inner surface of a mask when in use, in accordance with some embodiments of the present invention. The pressure is adjusted within the region formed between the inner surface of the mask and the face of the user covered by the inner surface of the mask, including the nose, mouth, and/or portions of the cheeks, when the mask is worn correctly by the user (sometimes referred to herein as “region” for brevity). The target air pressure is continuously maintained at the region, during inhalation and/or exhalation, and/or during various activity levels of the user where tidal volume and/or respirator rate vary, for example, sitting down, walking, and running.

The dynamic adaptation of the ventilator may be performed by a controller (e.g., computing device) that receives pressure data from a pressure sensor, and generates instructions (e.g., code, control signals) for controlling the ventilator, such as the blower (e.g., centrifugal fan(s) of the ventilator.

The controller generates instructions for dynamically adjusting the pressure within the region according to a target pressure, optionally a user specified setpoint of most comfort to the user. The instructions are dynamically generated and adapted according to user activity level, thus maintaining the target pressure providing the user with comfort at the user selected level.

The dynamically generated instructions may be for dynamic changing of the blower RPM, thus adjusting the active air channel delivering air flow into the mask with accordance to the breathing (i.e., inhalation and/or exhalation) of the user. The RPM is increased when inhaling and the RPM is slowed down when exhaling, which maintains the pressure inside the mask at the target pressure for keeping to the user selected comfort level.

One or more feedback sensors, for example pressure sensor(s), provide the data for closing the regulation closed loop. The operation as described provides microorganism free air supply to the user when inhaling, since inhaled air enters the device via an N99 or P100 (e.g., flat textile packaged filter) filter in the ventilator box, and exhaled air is released to the surroundings via the surface filter when operating for example, in single blower configuration.

At 1902, a target baseline pressure for the region is selected. The target baseline pressure is larger than the ambient pressure, providing a continuous positive pressure environment. The positive pressure environment provides a feeling of comfort and/or cooling to the portion of the face of the user located within the region (i.e., covered by the mask), and/or protects the user from coming in contract with air from the external environment via borders of the masks by continuously forcing air out of the mask to the external environment, and/or prevents a buildup of expired carbon dioxide.

Optionally the target baseline pressure is defined as an amount of pressure above the ambient pressure of the environment outside the mask.

The target baseline pressure may be selected by the user using a user interface connected to the ventilator and/or to the computing device. The user interface may be connected to the ventilator and/or computing device with an optional communication channel, for example, wired, optical and/or wireless such as USB, IR and/or blue tooth, for initial setup and/or adaptation. For example, by pressing up/down arrows on a user interface, selecting a predefined comfort setting, entering the pressure as a numerical value, and/or using previously selected settings found comfortable for that user. The selection may be done via a user interface, for example, connected to the ventilator (e.g., arrow keys) and/or using a smartphone.

At 1904, the current pressure at the region is computed. The current pressure may be computed based on pressure measurements of an internal pressure sensor sensing the pressure within the active air channel that actively delivers air to the region, and/or an ambient pressure sensor sensing the pressure of the environment outside the mask. The current pressure may be the difference between the internal pressure at the region and the ambient pressure.

The sensor(s) may be located, for example, at the exit port of the ventilator, as part of electronic circuitry of the ventilator, and/or in the region within the mask.

Alternatively or additionally, other measurements are made, which may be indicative of the respiratory rate of the user and/or amount of air required by the user, for example, air flow sensed by an air flow sensor, and/or acceleration sensed by an acceleration sensor. Such sensors may detected increased physical activity of the user, such as running, dancing, and/or other movements, indicating a higher demand for air by the user.

At 1906, instructions are generated for adjusting the ventilator for maintaining the target baseline pressure at the region. Optionally, the instructions are for adjusting the blower, for example, flow rate (e.g., liters per minute) and/or RPM of the fan.

The instructions may be generated during inhalation and/or exhalation. Optionally, the state of inhalation and/or the state of exhalation are automatically detected, and instructions are generated according to the detected state.

During inhalation, the air pressure at the region drops, due to the inspiration of the air by the user. In response, the instructions are for delivering additional air to the region and/or the instructions are for decreasing the removal of air from the region, in order to offset the dropping air pressure, and maintain the target baseline pressure during the inspiration. The additional delivered air and/or the less removed air, may provide increased comfort to the user, for example, avoiding a choking type feeling due to the lack of insufficient air, by the extra delivered air that provides a comfortable inhalation sensation.

During exhalation, the air pressure at the region increases, due to the exhalation of air by the user. In response, the instructions are for evacuating additional air from the region and/or the instructions are for decreasing the air actively delivered to the region, in order to offset the increasing air pressure, and maintain the target baseline pressure during the exhalation. The additional removed air and/or less actively delivered air, may provide increased comfort to the user, for example, avoiding a difficulty type feeling due to the increased resistance to exhalation provided by the mask, by the extra evacuated air which reduces the resistance to exhalation to the user.

Instruction may be generated for different implementations. Optionally, in a two blower configuration, where two fans may be independent controlled such as using respective control circuitry, the instructions may be generated for the air entry blower that delivers air into the mask, and/or for the air evacuation blower that evacuates air out of the mask, for example, different sets of instructions for execution by the different blowers. Instructions may be generated for both blowers (e.g., to create a combined effect) and/or for one blower at a time. For example, during inhalation, the instructions for execution by the air entry blower to increase the amount of air delivered to the region and/or the instructions may be for execution by the air evacuation blower to decrease the amount of air evacuated from the region. During exhalation, the instructions may be for execution by the air evacuation blower to increase the amount of air evacuated from the region, and/or the instructions may be for execution by the air entry blower to decrease the amount of air evacuated from the region. Optionally, in a single blower configuration, where the active air channel delivers air to the region, and the exhalation is via a passive air channel across the passive air filter of the mask, the instructions may be generated for the blower that delivers air into the mask, for maintaining the target baseline pressure at the region, for example, increasing air delivery during inhalation and/or decreasing air delivery during exhalation.

The instructions may be generated by the computing device (e.g., smartphone) that receives data from the sensor(s) via a wired and/or wireless communication channel, as described herein.

An exemplary process for generating instructions is now described.

Aps denotes the target baseline air pressure at the region (i.e., pressure above ambient pressure), and Ap denotes the measured actual pressure difference at the region (i.e., measure pressure at the region less ambient pressure), an error signal denoted e = Aps - Ap is generated and fed to the controller. The controller senses the pressure gradient and biases the control command denoted c correspondingly, using the following mathematical relationship:

The bias is generated by increase in sensed exhaled C02 generation and faster breathing rate due to more intensive physical activity

The control signal is used as input to a motor driver which increases/decreases the fan RPM which affects the mask pressure denoted p_m as felt by the user which in the sequel may change the set point to a target comfort.

The sensed overpressure is calculated as the difference between the mask pressure denoted p_m and the ambient pressure denoted p_a resulting the Ap generating the error.

At 1908, one or more of 1902-1906 are iterated, as the user inhales and exhales, and/or as the user changes activity levels, for maintaining the target baseline pressure at the region. The user may dynamically adjust the target baseline air pressure, for example, when the user is exercising, a higher target baseline air pressure may be selected to provide increased air flow for a more comfortable feeling, while when the user is sitting a lower target baseline air pressure may be selected to provide decreased air flow for the more comfortable feeling.

As said, the controller adapts itself to changes in user ventilation demand that may occur when he becomes more physically active such while running as compare with rest condition.

In an example, as breathing becomes more intensive and the respiratory rate increases, a gradual increase in ventilator delivered air supply to the mask may be provided, as indicated by an elevated pressure the controller operates correspondingly changing the blower RPM to comply with the changes in user breathing demand and, in so doing maintains the target baseline pressure at the region of the mask at the user selected comfort level.

The user may indicate the comfort level by touching a reinforcement button for increasing and/or reducing the over pressure, the rate increase. The combined signal of the breathing rate sensor plus the user comfort indication affects operating parameters such as setpoint pressure ps resulting the regulator ps.

Hence, following the initial nominal setting of the target baseline over pressure in the mask the user may adjust the target baseline air pressure while using it to the individual comfort level by clicking the up/down control switch.

The adaptive controller/regulator may maintain the target baseline air pressure by closing a feedback loop with controller, for example, a MPID controller which is a modified PID controller capable of sensing the breathing mode and increasing/decreasing the RPM accordingly.

Reference is now made to FIG. 20, which is a block diagram of a control circuit for dynamically maintaining a target baseline air pressure in a region of the mask, in accordance with some embodiments of the present invention.

Reference is now made to FIG. 21 which includes schematics depicting an exemplary user interface (e.g., graphical user interface (GUI)) for setting parameters for dynamic maintenance of the target baseline air pressure in the region of the mask, in accordance with some embodiments of the present invention.

Schematic 2102 depicts a graph of proportional integral derivative (PID) control status plots, for dynamic maintenance of the target baseline air pressure in the region of the mask. SP denote a set point, optionally the target baseline air pressure. PV denotes a point value, i.e., the current air pressure in the region of the mask. Phase denotes the phase during the respiratory cycle, for example rest = 0, inhalation = 1, exhalation = 2.

Schematic 2104 depicts a graph of PID output value (%), where positive denotes the intake fan, and negative denotes the exhaust fan.

Schematic 2106 depicts exemplary PID parameters, which may be adjustable, for example:

• PID: Proportional, Integral, Derivative - set control coefficients

• MIN MAX [%]: Set max & min PID output (MIN=0 for single fan unit)

• PERIOD [S] : control cycle time, default set to 0.1 Seconds

• SP[mBar]: Set Point - target pressure for each of the respiratory stages (Rest, Inhale,

Exhale)

• OUTPUT [%]: current output of PID, same as schematic 2104

• Automatic Mode: uncheck to disable PID control Schematic 2108 depicts setting of a pressure offset parameter for increasing accurate of the computed target baseline air pressure. When two absolute pressure sensors may be used, a first sensor measuring absolute ambient pressure and a second sensor measuring absolute pressure at the region of the mask. The target baseline air pressure is computed as the difference between the two sensor measurements. Due to tolerances between the sensors, there may be an offset between their readings even if they are placed at the same pressure. The “Pressure Offset” field 2110 may be used to correct this issue -the value is so that when the fans are OFF and no pressure is applied, the “PressureDif ’ value is close to zero, as shown in 2112.

Schematic 2114 depicts a setting for the fans (i.e., the blowers of the ventilator). In automatic mode, sliders 2116A-B control the minimum constant ventilation. In manual mode sliders 2116A-B control the ventilation.

Schematic 2118 denotes several options that may be selected by clicking respective buttons. Clicking the “Load” button triggers a synchronization of TechSoft parameters with the Respirator Unit (Respirator -> TechSoft). Clicking the “Save: button stores the current Respirator Unit parameters to nonvolatile storage (e.g., when the Respirator Unit powers up it loads the parameters from nonvolatile storage). Clicking the “OTA” is used for Over The Air firmware updates. It is noted that the term respiratory and ventilator may be used interchangeable.

Reference is now made to FIG. 22, which includes graphs of dynamically adjusted blower flow rate over time for maintaining a target baseline air pressure in the region of the mask, in accordance with some embodiments of the present invention.

Blower flow rate 2204 denotes a rate of air being delivered to the region of the mask via the active air channel by the ventilation, as described herein.

Baseline 2206 denotes the target baseline air pressure, which is an elevated mask reference baseline pressure relative to the ambient air pressure (i.e., atmospheric pressure level 2208), personally adapted to the user, for example, user selected.

It is noted that baseline 2206 remains constant over time.

Graph 2202A depicts a scenario where the blower increases flow rate during inspiration to maintain the target baseline pressure 2210. 2212 denotes an increased air supply to the region of the mask during elevated physical activity of the user.

Graph 2202B depicts a scenario similar to 2202A, where the blower reduces air flow during expiration 2214, as described herein.

Reference is now made to FIG. 23, which is a schematic of an exemplary scenario of an implementation of a respirator system 2300, in accordance with some embodiments of the present invention respirator system 2300 is being worn by a person 2350 going out for a run, for example, for protecting person 2350 from inhaling contaminated external air, for example, reducing risk of contracting a viral disease (e.g., COVID-19) and/or protection from pollution. Person 2350 is wearing mask 2302, which is connected to one or two tubes 2314 via respective apertures 2308 in mask 2302, as described herein. Tube(s) 2314 are connected to a ventilator 2316, which may include a single blower or two blowers, as described herein. Ventilator 2316 provides sufficient air flow for person 2350 while running, via the established active air channel, for person 2350 to breath, optionally by maintaining a baseline air pressure that is higher than the ambient air pressure, as described herein. A passive air flow channel may be established for passive inhalation and/or exhalation across mask 2302, for example, during failure of ventilator 2316 (e.g., battery runs out, malfunction, kink in tube 2314), as described herein.

The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

It is expected that during the life of a patent maturing from this application many relevant masks will be developed and the scope of the term mask is intended to include all such new technologies a priori.

As used herein the term “about” refers to ± 10 %.

The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to". This term encompasses the terms "consisting of" and "consisting essentially of".

The phrase "consisting essentially of" means that the composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments. The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.

Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.

Claims

WHAT IS CLAIMED IS:

1. A respirator system, comprising: a mask made of a flexible material that conforms to facial features of a user when worn and collapses when not worn, the mask including at least one filter positioned within an inner surface of the mask that when in use is located in proximity to a nose and mouth of the user, the at least one filter forming a passive air flow channel for transfer of air across the mask, the mask including at least one aperture and a closure mechanism; a ventilator connected to tubing connected to the at least one aperture of the mask, the ventilator generating an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask, wherein the closure mechanism located on the mask closes the aperture when the tubing is removed, thereby switching the mask from operating with the active air flow channel in an active mode to the mask operating using the passive air flow channel in a passive mode; and a controller configured for: receiving an indication of a target baseline air pressure for the region defined by the inner surface of the mask when worn by the user, receiving an indication of a real time air pressure at the region; and dynamically generating instructions for real time adaptation of the ventilator RPM for adjusting the air delivered by the active air channel for maintaining the target baseline air pressure, wherein the receiving the indication of the real time air pressure and the dynamically generating instructions are iterated a plurality of times over each one of a plurality of breathing cycles of the user.

2. The respirator system of claim 1, wherein the mask includes a first aperture connected to a first tube connected to the ventilator and associated with a first closure mechanism, and a second aperture connected to a second tube connected to the ventilator and associated with a second closure mechanism, wherein the active air flow channel generated by the ventilator includes air flowing from the ventilator through the first tube to the region of the mask and air flowing from the region of the mask through the second tube to the ventilator.

3. The respirator system of claim 2, further comprising a first filter associated with at least one of the first aperture, the first tube, and an air entry port of the ventilator, and a second filter associated with at least one of the second aperture, the second tube, and an air exit port of the ventilator.

4. The respirator system of claim 2, wherein the ventilator includes an air entry portion for delivery of air to the first tube and an air exhalation portion that evacuates air from the second tube, the air entry portion and the air exhalation portion housed within a single common housing of the ventilator and are hermetically sealed from one another.

5. The respirator system of claim 4, wherein the air entry portion includes an air entry blower, and the air exhalation portion includes an air exhalation blower, the air entry blower and air exhalation blower are independently controlled by a controller to achieve a synergistic effect in establishing the active air channel, and/or may be independently dynamically adapted to maintain a target air pressure within the region defined by the inner surface of mask during use.

6. The respirator system of claim 4, further comprising a barrier of the single common housing that is diagonally, creating a larger air entry chamber with entry and exit ports along a straight axis where air flow delivered to the mask is substantially along the straight axis, and a smaller air evacuation chamber when entry and exit ports are along an angle and/or curve, wherein air flow received from the mask is directed along the angle and/or curve.

7. The respirator system of claim 5, wherein an inlet port of an air entry chamber including the air entry blower and an outlet port of an air evacuation chamber including the air exhalation blower are located along a straight axis, the air entry chamber and air evacuation chamber being hermetically separated by a barrier positioned perpendicular to the straight axis.

8. The respirator system of claim 7, wherein an outlet port of the air entry chamber configured for connecting to the first tube and an inlet port of the air evacuation chamber configured for connecting to the second tube, are positioned side by side along a housing of the ventilator.

9. The respirator system of claim 1, wherein the ventilator includes a screen designed to be opened and closed, the screen including a flexible frame that changes size for accommodating a variety of sizes of a disposable and replaceable filter.

10. The respirator system of claim 1 , wherein the aperture comprises an inhalation port, wherein the tubing is connected to the inhalation port for establishment of the active air flow channel, and during disconnection of the tubing the closure mechanism closes the inhalation port for switching from the active air flow channel to the passive air flow channel.

11. The respirator system of claim 1, wherein the active air flow channel comprises an active filtered air low channel, wherein the ventilator includes a filter for generating the active filtered air flow channel.

12. The respirator system of claim 1, wherein the closure mechanism includes at least one leaflet and at least one tension element that is set to apply a stored tension force, when the tube is disconnected from the aperture, to urge the at least one leaflet to change orientation from a first state where the aperture is open to a second state for closing the aperture, and when the tube is connected to the aperture, tension is stored in the at least one tension element tension element by a change in orientation of the at least one leaflet from the second state to the first state, wherein when the aperture is closed by the closure mechanism, the mask operates in the passive mode, wherein air exhaled and inhaled by the user is transported by the passive air flow channel via the at least one filter mounted on inner surface of the mask.

13. The respirator system of claim 12, wherein tension applied by the at least one tension element to the tube within the aperture secures the tube in place within the aperture.

14. The respirator system of claim 12, wherein the at least one leaflet is set on a hinge for changing orientation from the first state to the second state, and the at least one tension element is associated with the hinge.

15. The respirator system of claim 1, wherein the mask includes a wide central portion and a left arm portion and a right arm portion extending from the wide central portion, at least one of the left arm portion and the right arm portion located in proximity to an aperture and including a tube connector for connecting at least a portion of the tube along a long axis of the respective left arm portion and/or right arm portion, while the mask is in use and while the tube is connected to the respective aperture and to the ventilator.

16. The respirator system of claim 15, wherein the connector comprises a tunnel formed by an inner surface of at least one of the left arm portion and the right arm portion, the tunnel sized for including the portion of the tube encapsulated by the inner surface.

17. The respirator system of claim 15, wherein a cross section of the portion of the tube along the long axis includes a straight portion that contacts the left arm portion and/or the right arm portion and a curved arc shaped portion connected to the straight portion, the curved arc shaped portion does not contact the left arm portion and/or the right arm portion.

18. The respirator system of claim 15, wherein the portion of the tube located along the long axis is integrated with the respective left arm portion and/or right arm portion, and wherein the portion of the tube further includes a connector at the distal end thereof for detachably connecting to a second tube connected to the ventilator.

19. The respirator system of claim 15, further comprising an elbow connector having a curve selected to connect between the aperture and the portion of the tube located along the long axis.

20. The respirator system of claim 19, wherein the elbow connector is set for connecting to the aperture of the mask, for rotation relative to the aperture, and for detaching from the connection to the aperture of the mask by rotation and pulling of the elbow connected.

21. The respirator system of claim 1, further comprising: at least one air filter included in the ventilator, the at least one air filter including an indication element; an indicator reading element included in the ventilator, the indicator reading element sensing the indication element; at least one pressure sensor that senses pressure of the active air channel; and a non-transitory memory storing code instructions that when executed by at least one hardware processor cause the hardware processor to: estimate when the at least one air filter is to be replaced according to an analysis of dynamic pressure changes of the active air channel passing through the at least one air filter sensed by the at least one pressure sensor.

22. The respirator system of claim 21, wherein the indication element stores an indication of a lifetime of the at least one air filter when used during a baseline pressure environment, and wherein the analysis of dynamic pressure changes of the active air channel passing through the at least one air filter reduces the lifetime when the dynamic pressure changes are above the baseline pressure environment.

23. The respirator system of claim 1, wherein the ventilator further comprises an inlet matching element that includes a first inlet having a larger size substantially corresponding to dimensions of an inlet filter of the ventilator, and a second inlet having a smaller size substantially corresponding to dimensions of a ventilator inlet of a blower of the ventilator.

24. The respirator system of claim 1, wherein the controller is further configured for receiving a measurement of at least one sensor sensing the region, and adjusting an amount of supplemental oxygen delivered by the ventilator to the region via the active air flow channel according to the measurement of the at least one sensor.

25. The respiratory system of claim 1 , wherein the target baseline air pressure is defined as an air pressure increase over an ambient air pressure of an environment external to the mask.

26. The respirator system of claim 1, wherein when the indication of the real time air pressure denotes a decrease in air pressure during an inspiration phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for increasing the air delivered by the active air channel.

27. The respirator system of claim 1, wherein when the indication of the real time air pressure denotes an increase in air pressure in the region defined by the inner surface of the mask during an exhalation phase of a breathing cycle and/or during increased physical activity by the user, the instructions are for decreasing the air pressure delivered by the active air channel to the region defined by the inner surface of the mask, for maintaining the target baseline air pressure.

28. The respirator system of claim 1, wherein when the indication of the real time air pressure denotes an increase in air pressure in the region defined by the inner surface of the mask during an exhalation phase of a breathing cycle and/or during increased physical activity by the user, the instructions are for increasing the air removed from the region defined by the inner surface of the mask by the active air channel, for maintaining the target baseline air pressure.

29. The respirator system of claim 1, wherein when the indication of the real time air pressure denotes a decrease in air pressure in the region defined by the inner surface of the mask during an inspiratory phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for increasing the air pressure delivered by the active air channel to the region defined by the inner surface of the mask, for maintaining the target baseline air pressure.

30. The respirator system of claim 1, wherein when the indication of the real time air pressure denotes a decrease in air pressure in the region defined by the inner surface of the mask during an inspiratory phase of a breathing cycle and/or during decreased physical activity by the user, the instructions are for decreasing the air removed from the region defined by the inner surface of the mask by the active air channel, for maintaining the target baseline air pressure.

31. The respirator system of claim 1 , wherein the instructions are generated for parallel execution by an air entry blower that delivers air into the mask, and for an air evacuation blower that evacuates air out of the mask.

32. The respirator system of claim 31, wherein the instructions for execution by the air entry blower are to increase the amount of air delivered to the region and the instructions may be for execution by the air evacuation blower to decrease the amount of air evacuated from the region.

33. The respirator system of claim 31, wherein the instructions for execution by the air evacuation blower are to increase the amount of air evacuated from the region, and the instructions for execution by the air entry blower are to decrease the amount of air evacuated from the region.

34. The respirator system of claim 1, wherein the instructions are generated for a single blower that delivers air to the region via the active air channel, wherein exhalation is via a passive air channel across the air filter of the mask, the instructions are for increasing air delivery and/or decreasing air delivery for maintaining the target baseline air pressure.

35. The respirator system of claim 1, wherein the target baseline air pressure is selectable and/or adjustable by the user by an interface connected to the ventilator, wherein the selected and/or adjusted target baseline air pressure is maintained.

36. A system for maintaining a target baseline air pressure in a region of a mask, comprising: at least one hardware processor executing a code for: receiving an indication of a target baseline air pressure for the region defined by the inner surface of the mask when worn by the user, wherein the mask is made of a flexible material that conforms to facial features of the user when worn and collapses when not worn, the mask including at least one aperture for communication with a tube within which is established an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask by a ventilator; receiving an indication of a real time air pressure at the region; and dynamically generating instructions for real time adaptation of the ventilator for adjusting the air delivered by the active air channel maintaining the target baseline air pressure, wherein the receiving the indication of the real time air pressure and the dynamically generating instructions are iterated a plurality of times over each one of a plurality of breathing cycles of the user.

37. The system of claim 36, wherein the target baseline air pressure is selectable and/or adjustable by the user by an interface connected to the ventilator, wherein the selected and/or adjusted target baseline air pressure is maintained.

38. The system of claim 36, wherein an air flow rate of the active air channel is automatically adjusted by the ventilator a user requirement of a higher breathing rate, as sensed by one or more sensors.

39. A respirator system, comprising: a mask made of a flexible material that conforms to facial features of a user when worn and collapses when not worn, the mask including at least one filter positioned within an inner surface of the mask that when in use is located in proximity to a nose and mouth of the user, the at least one filter forming a passive air flow channel for transfer of air across the mask, the mask including at least one aperture and a closure mechanism; a ventilator connected to tubing connected to the at least one aperture of the mask, the ventilator generating an active air flow channel for at least one of active delivery of air to the mask and active evacuation of air from the mask, and wherein the closure mechanism located on the mask closes the aperture when the tubing is removed, thereby switching the mask from operating with the active air flow channel in an active mode to the mask operating using the passive air flow channel in a passive mode.