WO2021209988A1 - UPGRADING A BiPAP DEVICE TO A VENTILATOR SYSTEM FOR TREATING ACUTE RESPIRATORY DISTRESS SYNDROME - Google Patents

Abstract

A system for ventilating a patient with an air and oxygen mix, the system including a BiPAP device, an oxygen source, and a monitoring unit for monitoring ventilation parameters. A method for providing an air and oxygen mix, the method including providing air using a BiPAP device, providing oxygen, mixing the air and the oxygen, monitoring ventilation parameters, and providing the air and oxygen mix. Related apparatus and methods are also described.

Description

UPGRADING A BiPAP DEVICE TO A VENTILATOR SYSTEM FOR TREATING ACUTE

RESPIRATORY DISTRESS SYNDROME

RELATED APPLICATION/S

This application claims the benefit of priority of Israel Patent Application No. 273938 filed on 12 April 2020, the contents of which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND

The present disclosure, in some embodiments thereof, relates to upgrading a BiPAP (Bi level Positive Airway Pressure) device to a ventilation system which can be used to treat ARDS (Acute Respiratory Distress Syndrome) patients and, more particularly, but not exclusively, to upgrading a BiPAP Ventilator for COVID-19 patients. However, such a ventilation system can be used for additional purposes.

The disclosures of all references mentioned above and throughout the present specification, as well as the disclosures of all references mentioned in those references, are hereby incorporated herein by reference.

SUMMARY

The present disclosure describes a setup allowing to ventilate an ARDS patient with a commercial BiPaP device by adding electronic monitors to monitor and alert on critical respiratory parameter changes.

The present disclosure also describes a setup allowing to ventilate an ARDS patient with a commercial BiPaP device by adding mechanical connections to enable ventilating the patient via one tube, and optionally filtering the patient’s exhalations to reduce possibility of infection.

According to an aspect of some embodiments of the present disclosure there is provided a system for ventilating a patient with an air and oxygen mix, the system including a BiPAP device, an oxygen source, and a monitoring unit for monitoring ventilation parameters.

According to some embodiments of the disclosure, oxygen from the oxygen source is added to air exiting from the BiPAP device. According to some embodiments of the disclosure, oxygen from the oxygen source is added to air prior to the air entering the BiPAP device. According to some embodiments of the disclosure, oxygen from the oxygen source enters directly into the BiPAP device.

According to some embodiments of the disclosure, the monitor includes a tablet for providing a user interface to the monitoring unit. According to some embodiments of the disclosure, further including a PEEP valve attached to the system distal to exhaled air exiting from a patient.

According to some embodiments of the disclosure, the monitoring unit is configured to monitor ventilation parameters distally along gas flow relative to the oxygen and air mix and relative to the BiPAP device.

According to some embodiments of the disclosure, further including a non-re-breathable valve.

According to some embodiments of the disclosure, further including a HMEF (Heat and Moisture Exchange) filter.

According to an aspect of some embodiments of the present disclosure there is provided a method for providing an air and oxygen mix, the method including providing air using a BiPAP device, providing oxygen, mixing the air and the oxygen, monitoring ventilation parameters, and providing the air and oxygen mix.

According to some embodiments of the disclosure, mixing the air and the oxygen is performed downstream of the BiPAP device, relative to a direction of air flow. According to some embodiments of the disclosure, mixing the air and the oxygen is performed upstream of the BiPAP device relative to a direction of air flow.

According to some embodiments of the disclosure, further including filtering exhaled air to reduce contamination.

According to some embodiments of the disclosure, further including using a non-re- breathable valve to prevent exhaled air from flowing back into system components.

According to an aspect of some embodiments of the present disclosure there is provided a method of upgrading a BiPAP device to supply an air and oxygen mix as described herein.

According to an aspect of some embodiments of the present disclosure there is provided a method of upgrading a BiPAP device to supply an air and oxygen mix as shown in the drawings and described herein.

According to an aspect of some embodiments of the present disclosure there is provided a method of monitoring a BiPAP device when supplying an air and oxygen mix as described herein.

According to an aspect of some embodiments of the present disclosure there is provided a method of monitoring a BiPAP device when supplying an air and oxygen mix as shown in the drawings and described herein.

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 disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the disclosure, 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.

As will be appreciated by one skilled in the art, some embodiments of the present disclosure may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present disclosure may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the disclosure can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the disclosure, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.

For example, hardware for performing selected tasks according to some embodiments of the disclosure could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the disclosure, one or more tasks according to some exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. Optionally, a network connection is provided as well. A display and/or a user input device such as a keyboard or mouse are optionally provided as well.

Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the disclosure. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, 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), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

Computer program code for carrying out operations for some embodiments of the present disclosure may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code 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).

Some embodiments of the present disclosure may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the disclosure. 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 program instructions. These computer 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 program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.

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

Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as monitoring ventilation parameters, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING! SI

Some embodiments of the disclosure 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 disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosure may be practiced.

In the drawings:

FIG. l is a simplified graph describing typical ventilation parameter according to prior art;

FIG. 2 is a simplified illustration of a ventilation system constructed according to an example embodiment;

FIG. 3 is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment; FIG. 4A is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment;

FIG. 4B is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment;

FIG. 4C is a simplified block diagram illustration of a portion of a ventilation system constructed according to an example embodiment;

FIG. 4D is a simplified block diagram illustration of a portion of a ventilation system constructed according to an example embodiment;

FIG. 5 is a simplified flow chart of a method for providing an air and oxygen mix according to an example embodiment;

FIG. 6A is a simplified illustration of a ventilation system constructed according to an example embodiment;

FIG. 6B is a simplified illustration of a monitor connected to a ventilation tube constructed according to an example embodiment;

FIG. 6C is a simplified illustration of a ventilation system constructed according to an example embodiment;

FIG. 7 is a simplified graph illustrating ventilation pressure over time according to an example embodiment;

FIG. 8, which is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment;

FIG. 9A-9H are images of connectors and piping of a ventilation system constructed according to an example embodiment;

FIG. 10A is a simplified isometric drawing of a monitor for a ventilation system constructed according to an example embodiment;

FIG. 10B is a simplified drawing of the monitor of Figure 10A;

FIG. IOC is a simplified drawing of the monitor of Figure 10A;

FIG. 10D and 10E are simplified illustrations of one or more PCBs in a monitor for a ventilation system constructed according to an example embodiment;

FIG. 11 is a simplified illustration of a connection of one or more sensors to a gas flow pipe in a ventilation system constructed according to an example embodiment; and

FIG. 12 is a simplified illustration of an electronic layout scheme for a monitor in a ventilation system constructed according to an example embodiment. DESCRIPTION OF SPECIFIC EMBODIMENTS

The present disclosure, in some embodiments thereof, relates to upgrading a BiPAP device to a ventilation system which can be used to treat ARDS (Acute Respiratory Distress Syndrome) patients and, more particularly, but not exclusively, to upgrading a BiPAP Ventilator for COVID- 19 patients. However, such a ventilation system can be used for additional purposes.

Introduction

The following introduction briefly describes a non-limiting example problem and a non limiting example solution, in order to put a reader in one non-limiting, example introductory context.

Patients which require machine ventilation, under less-than optimal conditions such as during the present COVID-19 pandemic, may be treated with Continuous Mandatory Ventilation (CMV), which is a mode of mechanical ventilation in which breaths are delivered based on set variables.

In some cases, the ventilation will be to a patient who has been intubated.

In some embodiments, a ventilation system suitable for us in case of the non-limiting example now described includes an expiration filter, for reducing or eliminating viruses in air exiting the ventilation system.

In some embodiments, the ventilation system provides a respiratory rate of 12-20 per minute.

In some embodiments, it is enough to monitor pressure of air or air-mixture supply, or a value of tidal volume calculated bases on the pressure.

In some embodiments, the I:E ratio (inspiration time/expiration time) of the system is in a range of 1.2-1.5.

In some embodiments, the tidal volume supplied is in a range of 200-800 milliliters (ml).

In some embodiments, Positive End-Expiratory Pressure (PEEP) is in a range of 4-16 cm H2O. PEEP is a positive pressure that remains in airways at an end of a respiratory cycle (end of exhalation), that is greater than the atmospheric pressure in mechanically ventilated patients.

In some embodiments, the ventilation system optionally provides pressures greater than 40 cm H2O above PEEP.

In some embodiments, the ventilation system optionally includes a trigger operated by pressure.

In some embodiments, the ventilation system optionally includes an air flow sensor (or air- mixture flow sensor). For purposes of better understanding some embodiments of the present disclosure, reference is first made to the graph illustrated in Figure 1.

Reference is now made to Figure 1, which is a simplified graph describing typical ventilation parameter according to prior art.

Figure 1 is a graph showing an X-axis of pressure applied by a ventilator, in units of cm FLO, and a Y-axis of tidal volume, in units of milliliters (ml).

Figure 1 shows that a low value of tidal volume 108 is potentially dangerous to a patient, for fear of allowing lung alveoli to close, or repetitively close and re-open; and a high value of tidal volume 104 is dangerous to the patient, for fear of over-distending the lung alveoli. Figure 1 shows a value 110 of 30 cm FLO pressure above which the tidal volume is typically too high.

Figure 1 also shows a line 116 of points which describe a typical ventilating path which shows how much tidal volume is added at what pressure.

A section of the line 116, which extends between a first point 112 and a second point 114, shows a typical ventilating procedure which avoids the dangers of the low value of tidal volume 108 and the high value of tidal volume 104.

Initiation of Lung Protective Ventilation (LPV) typically follows a procedure as described below: setting Tidal Volume (VT) in a range of 6-8 ml per kg patient body weight; setting Respiratory Rate (RR) to approximate Minute Ventilation (MV), where MV = VT x RR; setting I:E ratio (inspiration time/expiration time) < 1, so inspiration time is less than expiration time. Such an I:E ratio requires higher flow rates than, for example, I:E ratio = 1; monitoring for intrinsic PEEP. Intrinsic positive end-expiratory pressure (PEEP) or auto- PEEP is a complication of mechanical ventilation that most frequently occurs in patients with COPD or asthma who require prolonged expiratory phase of respiration. These patients may have difficulty in totally exhaling the ventilator-delivered tidal volume before the next machine breath is delivered. When this problem occurs, a portion of each subsequent tidal volume may be retained in the patient's lungs. If this goes unrecognized, the patient's peak airway pressure may increase to a level that results in barotrauma, volutrauma, hypotension, patient-ventilator dyssynchrony, or death; setting inspiratory flow rate above patient demand, typically above 60 Liters (L)/minute; setting FiCh (Fraction of inspired Oxygen) is a molar or volumetric fraction of oxygen in inhaled air) at 1.00, and titrating down; and for severe ARDS setting PEEP to 5-10 cm H20 or higher. In some embodiments, PEEP is optionally set corresponding to severity of oxygen impairment. In some embodiments, the following procedure is used: titrating the Fi02 to a lowest value that maintains a target SpCh in a range of 88-93%; setting a corresponding PEEP, optionally based on each individual patient, optionally a higher PEEP for moderate to severe ARDS, optionally according to the following tables:

Table 1 : Lower PEEP and higher Fi02

Table 2: Higher PEEP and lower Fi02

Before explaining at least one embodiment of the disclosure in detail, it is to be understood that the disclosure 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 disclosure is capable of other embodiments or of being practiced or carried out in various ways. Overview

An aspect of some embodiments relates to ventilating massive number of patients in a pandemic scenario where there is a significant shortage in regular/commercial available ICU (Intensive Care Unit) ventilators.

In a case of an epidemic, there may be a need to ventilate more patients than there are ICU ventilators available. A solution to such a problem can be upgrading a BiPAP device to a ventilation system which can be used to treat ARDS (Acute Respiratory Distress Syndrome) patients, for example treating COVID-19 patients.

The following features were determined to characterize a medical ventilator: provide a mixture of air and oxygen; filter the mixture of air and oxygen; control important flow parameters; provide various ventilation programs based on pressure and volume; warn of patient condition by monitoring oxygen saturation in blood and/or CO2 concentration in blood; and ability to be used on an intubated patient.

The following features were determined to characterize a basic BiPAP device: designed for use as a home breathing aid; designed for use in a non-invasive fashion, using a mask rather than intubation; typically has a compressor and a valve with two set pressures: a high pressure for inspiration and a lower pressure for expiration.

A CPAP device typically provides just one pressure, which a patient resists when expiring air.

The following table compares a typical BiPAP device with a medical ventilator: Table 3:

Reference is now made to Figure 2, which is a simplified illustration of a ventilation system constructed according to an example embodiment.

Figure 2 shows one example embodiment of a ventilation system constructed around a BiPAP device. It is noted that there are other example embodiments.

Some of the components of the ventilation system in shown in Figure 2 include: an air input 202; an oxygen source 204, such as, by way of some non-limiting examples, an oxygen tank or an oxygen supply nozzle provided in a hospital wall; a mixer 206 for mixing the air and the oxygen. In some embodiments, the mixer 206 enables optionally setting a relative concentration of the oxygen-to-air ratio; a first tube 208 providing an oxygen-and-air mixture to an input of a BiPAP device 210; the BiPAP device 210; a second tube 212 connecting an output of the BiPAP device 210 to an input of a monitor

214; the monitor 214, for monitoring one or more parameters such as flow rate, flow volume, pressure, oxygen concentration, and so on, and optionally providing waming(s) of parameters having measured values outside a desired range; a third tube 216 connecting an output of the monitor 214 to an intubation tube 220 intubated in a patient 218; and an optional filter 222, for optionally filtering exhaled air to reduce and/or remove contamination such as viruses, for example COVID-19 viruses, from the exhaled air. Such a filter is optional - in some embodiments the filter is used, keeping the patient’s environment cleaner and/or safer for health care workers; in some embodiments the filter is not used, or even not connected to the ventilation system, providing less resistance to exhaling.

In some embodiments, most of the components are commercially available medical components, with an exception of the monitor 214. Such embodiments potentially enable upgrading a BiPAP device by assembling commonly available components to plus the monitor 214 component to a medically-useful ventilation system for use in ventilating ARDS patients.

Figure 2 shows a ventilation system where the mixer 206 mixes air and oxygen before entry into the BiPAP device 210. In some embodiments, air enters into the BiPAP device 210, and oxygen is mixed into the air later on along the flow toward the patient 218.

The ventilation system shown in Figure 2, as well as in other drawings in the specification, provides a solution to a problem of how to upgrade BiPAP devices, which may already be approved by regulatory bodies, to a ventilation system for use on ARDS patients, by mixing oxygen into the air stream, by providing a monitoring and/or warning component, and by optionally filtering exhaled air.

Overview describing additional aspects

An aspect of some embodiments relates to upgrading BiPAP devices to being capable of providing ventilation to ARDS patients, and in some embodiments to providing ventilation to intubated patients.

In some embodiments, a monitoring unit is added downstream of a BiPAP device, in order to monitor that the BiPAP device provides one or more of the following: a correct mixture of air and oxygen; a correct tidal volume per inspiration/expiration cycle; the air and oxygen mixture at a correct pressure; the air and oxygen mixture at a correct moisture level; and the air and oxygen mixture at a correct temperature. upgrading BiPAP devices to being capable of providing ventilation to ARDS patients according to embodiments described herein is potentially suitable for substantially any BiPAP machine.

In some embodiments, oxygen is mixed with air prior to entering a BiPAP device.

In some embodiments, air enters the BiPAP device, and oxygen is mixed with air exiting the BiPAP device.

In some embodiments, the monitoring distal to input of all gasses potentially enables to monitor an air-and-oxygen mixture as will be provided to a patient, and not before a significant alteration of the mixture.

An aspect of some embodiments relates to mixing oxygen with air exiting the BiPAP device. Oxygen passing through a BiPAP device, or similar device, may potentially produce a dangerous safety-related situation. Oxygen, or oxygen-enriched air inside a working machine may potentially participate in causing a fire.

In some embodiments, oxygen is mixed with air exiting the BiPAP device, and the oxygen does not pass through the BiPAP device.

In some embodiments, the oxygen does not pass through any more electrical devices which contain motors and/or other moving parts which may produce sparks and create a safety hazard.

An aspect of some embodiments relates to using a non-re-breathing valve connected to an intubation tube inserted into a patient. The non-re-breathing valve potentially prevents contaminated air exhaled by the patient from flowing back along tubes which provide the air-and- oxygen mixture to the patient.

Preventing the contaminated air from flowing back along tubes which provide the air-and- oxygen mixture to the patient potentially enables using upstream portions of the system for other patients, by keeping them from being contaminated. Such a consideration is especially important when a ventilating system should be transferred as rapidly as possible from one patient to another.

In some embodiments, a non-re-breathing valve is connected to a patient’s intubation tube. The non-re-breathing valve accepts an air-and-oxygen mixture into an input of the valve, and directs the mixture into the intubation tube. When the patient exhales, the non-re-breathing valve directs exhaled air to an output of the valve, not common with the input of the valve. The non-re breathing valve prevents the exhaled air from flowing back along tubes which provide the air-and- oxygen mixture to the patient.

In some embodiments, two patients can optionally be provided with ventilation from one BiPAP device, optionally by using a separate non-re-breathing valve for each patient, ensuring that contaminated air or gas mixture does not flow back from a first patient and contaminate the air or gas mixture provided to a second patient.

An aspect of some embodiments relates to using a filter connected to an exit of exhaled air, so as to filter the exhaled air.

In some embodiments, the filter is capable of reducing contamination exhaled by a patient.

In some embodiments, the filter is capable of reducing transfer of viruses exhaled by a patient. In some embodiments, the filter is capable of reducing transfer of COVID-19 viruses exhaled by a patient.

In some embodiments, the filter is capable of preventing transfer of viruses exhaled by a patient. In some embodiments, the filter is capable of preventing transfer of COVID-19 viruses exhaled by a patient.

Reference is now made to Figure 3, which is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment.

Figure 3 shows one example embodiment of a ventilation system constructed around a BiPAP device. It is noted that there are other example embodiments.

Some of the components of the ventilation system in shown in Figure 3 include: a mixer 306 for mixing air from an air source and oxygen from an oxygen source. In some embodiments, the mixer 306 enables optionally controlling flow or pressure of one or more of the air and the oxygen, and/or total output flow from the mixer 306; a BiPAP device 310; a monitor 314, optionally including one or more sensors 313, for measuring one or more parameters such as flow rate, flow volume, pressure, oxygen concentration, and so on, a control unit 315 for receiving measurements from the sensors 313 and optionally determining whether the measurements are within a specific desired range, and a warning unit 317, for optionally providing warning when one or more of the measure parameters are not within a specified range. In some embodiments, the warning unit 317 sends warning wirelessly to a remote monitoring station. In some embodiments, the warning unit 317 sends warning by wire, e.g. communication network or electric conductor, to a remote monitoring station. In some embodiments, the warning unit 317 provides visible warning, such as warning lights, flashing display, and so on. In some embodiments, the warning unit 317 provides audible warning, such as a warning sound; a non-re-breathable valve 324, which provides an air and oxygen mixture to an intubated tube 320.

In some embodiments, an additional optional filter 322 is placed on an exhaled air exit from the non-re-breathable valve 324, to clean the exhaled air, for example from viruses such as COVID- 19 viruses, to help maintain cleanliness for the surroundings of a patient.

Reference is now made to Figure 4A, which is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment.

Figure 4A shows a ventilation system in which air and oxygen are mixed before entering a BiPAP device.

Figure 4A shows a ventilation system which includes: a mixer 406, for mixing air from an air source 402 and oxygen from an oxygen source 404; a BiPAP device 408 for providing the air and oxygen mixture to an intubation tube 412; a monitor unit 410 for monitoring the air and oxygen mixture provided to the intubation tube 412; and the intubation tube 412.

It is noted that the mixer 406, the BiPAP device 408, and the intubation tube 412, as well as various additional tubes used for connecting the above-mentioned components, can be standard components such as typically used in medical systems.

Reference is now made to Figure 4B, which is a simplified block diagram illustration of a ventilation system constructed according to an example embodiment.

Figure 4B shows a ventilation system in which oxygen is mixed into air after exiting a BiPAP device.

Figure 4B shows a ventilation system which includes: a BiPAP device 428, accepting input of air from an air source 422; a mixer 426 for mixing air exiting the BiPAP device 428 with oxygen from an oxygen source 424; a monitor unit 430 for monitoring the air and oxygen mixture provided by the mixer 426; and an intubation tube 432.

It is noted that the mixer 426, the BiPAP device 428, and the intubation tube 432, as well as various additional tubes used for connecting the above-mentioned components, can be standard components such as typically used in medical systems.

Reference is now made to Figure 4C, which is a simplified block diagram illustration of a portion of a ventilation system constructed according to an example embodiment.

Figure 4C shows use of a non-re-breathable valve used in conjunction with an intubation tube enabling exhaled air not to leak back into airways.

Figure 4C shows an air-and-oxygen mix entering 441 a non-re-breathable valve 444; the air-and-oxygen mix exiting 443 the non-re-breathable valve 444 and entering an intubation tube 442; exhaled air exiting 445 the intubation tube 442 and entering the non-re-breathable valve 444; and the exhaled air exiting 447 the non-re-breathable valve 444.

Figure 4C illustrates the operation of the non-re-breathable valve 444.

In some embodiments, the exhaled air 447 may be contaminated, for example virally contaminated, for example with the COVID-19 virus.

Reference is now additionally made to Figure 4D, which is a simplified block diagram illustration of a portion of a ventilation system constructed according to an example embodiment.

Figure 4D shows use of a non-re-breathable valve used in conjunction with an intubation tube enabling exhaled air not to leak back into airways, and also with a filter to clean exhaled air.

Figure 4D shows the components of Figure 4C, operating as described above with reference to Figure 4C.

Figure 4D also shows exhaled air 447 entering into a filter 448, and exiting as filtered air

449.

In some embodiments, the filter 448 is capable of preventing viruses from passing through the filter 448.

In some embodiments, the filter 448 is capable of preventing the COVID-19 virus from passing through the filter 448.

In some embodiments, the filter 448 is capable of reducing a number of viruses from passing through the filter 448. Reference is now made to Figure 5, which is a simplified flow chart of a method for providing an air and oxygen mix according to an example embodiment.

The method of Figure 5 includes: providing air using a BiPAP device (502); providing oxygen (504); mixing the air and the oxygen (506); monitoring ventilation parameters (508); and providing the air and oxygen mix (510).

Reference is now made to Figure 6A, which is a simplified illustration of a ventilation system constructed according to an example embodiment.

Figure 6A shows one example embodiment of a ventilation system constructed around a BiPAP device, and mixing oxygen with air after the air exits from the BiPAP device, such as also shown in Figure 4B.

Some of the components of the ventilation system in shown in Figure 6A include: a BiPAP device 602, providing air into a first tube 601; a second tube 603 providing oxygen from an oxygen source 604 into the first tube 601; a monitor 606, optionally including one or more sensors, for measuring one or more parameters such as flow rate, flow volume, pressure, oxygen concentration, and so on; a third tube 607 exiting from the monitor 606, leading a mixture of oxygen and air to a non- re-breathable valve 608; a non-re-breathable valve 608, which provides an air and oxygen mixture to a connector 612 for connecting to an intubating tube not shown; and an optional Positive End-Expiratory Pressure (PEEP) filter 614 connected to an exit of the non-re-breathable valve 608.

In some embodiments, an additional optional filter 610 is placed between the non-re- breathable valve 608 and the connector 612.

Some additional considerations are now described, which potentially apply to some embodiments described herein.

A BiPAP device typically enables providing air at two different positive pressures for assisting a patient’s breathing, or ventilating patients who are not severely affected by respiratory distress. A first air pressure is termed IPAP - Inhalation Positive Air Pressure, typically 15-40 cm FbO. A second air pressure is termed EPAP - Exhalation Positive Air Pressure, typically 0-20 cm

H₂O. A BiPAP device is typically used to provide air under pressure to a face mask, and in an open-loop fashion, that is, exhaled air is exhaled out of the mask with no further treatment.

A BiPAP device is typically controlled by controlling the air pressure.

A BiPAP device is typically configurable for the following parameters: respiratory rate;

I:E ratio - a ratio of inspiration time to exhalation time; air pressure(s); and optionally detecting a patient’s self-breathing and optionally changing breathing assistance parameters based on the detecting.

Some BiPAP devices can provide some of the following warnings: high pressure; low pressure; estimated high tidal volume; and estimated low tidal volume.

Some drawbacks of many BiPAP devices include one or more of: typically not capable of ventilating at a controllable oxygen enrichment, even though some BiPAP devices can mechanically connect oxygen in parallel; typically not able to provide higher oxygen concentrations.

Reference is now made to Figure 6B, which is a simplified illustration of a monitor connected to a ventilation tube constructed according to an example embodiment.

Figure 6B shows a monitor 628 sampling from a ventilation tube 620, the monitor 628 being located off a direct air/gas flow through a ventilation tube 620, and sampling gas/air from the ventilation tube 620.

Figure 6B shows the monitor 628 connected by one or more sampling tube(s) 622 624 to the ventilation tube 620. The monitor 628 shown in Figure 6B includes a display screen 626.

In some embodiments, the display screen 626 is a tablet 626, which provides functionalities for displaying, input (by touch screen), sound (optionally sound output by the tablet’s speaker, for example for producing warning sounds and/or voice instructions to a user, and optionally sound input by a user, for example for control of the monitor).

Reference is now made to Figure 6C, which is a simplified illustration of a ventilation system constructed according to an example embodiment.

Figure 6C shows the ventilation system with a monitor 650 being located off a direct air/gas flow through ventilation tube(s), and sampling from the ventilation tube(s). Figure 6C shows one example embodiment of a ventilation system constructed around a BiPAP device 630, and mixing oxygen with air 634 after the air exits from the BiPAP device 630. Some of the components of the ventilation system in shown in Figure 6C include: a BiPAP device 630, providing air into one or more sections of a first tube 632; a second tube 633 providing oxygen from an oxygen source (not shown) into the first tube

632; a third tube 636 leading a mixture of oxygen and air to a non-re-breathable valve 640; the non-re-breathable valve 640, which provides an air and oxygen mixture to a connector 646 for connecting to an intubating tube not shown; a monitor 650, optionally including one or more sensors, for measuring one or more parameters such as flow rate, flow volume, pressure, oxygen concentration, and so on; various connecting pipes and/or wires, 652 654 656 for sampling various parameter of gas/air flowing to and from the connector 644 that connects to connector 646; and an optional Positive End-Expiratory Pressure (PEEP) filter 658 connected to an exit of the non-re-breathable valve 640.

In some embodiments, an additional optional filter 642 is placed between the non-re- breathable valve 640 and the connector 646.

Reference is now made to Figure 7, which is a simplified graph illustrating ventilation pressure over time according to an example embodiment.

The graph of Figure 7 has an X-axis 704 showing qualitative time, and a Y-axis 702 showing qualitative air pressure.

A line 708 describes air pressure provided over time by a BiPAP device.

Reading from left to right, the provided air pressure starts by rising to a high, IPAP level 716, during a period of inhalation 706; then lowers to a lower, EPAP level 714, during a period of exhalation 712; then rising to a high, IPAP level 716, during an additional period of inhalation 706, and so on.

Adding oxygen to air after the air exits from a BiPAP device can potentially cause difficulty in setting and/or controlling air-and-oxygen pressure and/or oxygen-to-air ratio.

In some embodiments, monitoring the above-mentioned parameters after mixing oxygen and air can potentially enable setting and/or controlling the above-mentioned parameters, either manually by an operator, or automatically, through setting oxygen pressure and/or flow and BiPAP settings.

Adding oxygen to air before entry to a BiPAP device can potentially cause safety problems (oxygen entering the BiPAP device) and mechanical design changes. In some embodiments, a filter is added to filter exhaled air, such as, by way of a non-limiting example, a Positive End-Expiratory Pressure (PEEP) filter. In some embodiments, adding the filter causes raising pressure of provided oxygen and air, and a suitable selection of a filter and calculation of corresponding pressure settings is optionally performed.

In some embodiments, an oxygen sensor is optionally added to monitor the oxygen and air flow, to potentially enable setting and/or controlling total amount of oxygen, or oxygen-to-other- gasses ratio or oxygen-to-air ratio.

In some embodiments, oxygen saturation values measured in a patient’s body are optionally used to potentially enable setting and/or controlling total amount of oxygen, or oxygen-to-other- gasses ratio or oxygen-to-air ratio.

In some embodiments, a ventilation system constructed according to various embodiments described here will provide one or more of the following features: parts of the system which contact air and/or oxygen provided to a patient abide by medical standard; in some embodiments, a malfunction of an in-line monitoring unit positioned distally to a BiPAP device along the air flow will not prevent the BiPAP device from continuing to operate; in some embodiments, the BiPAP is optionally controlled solely by controlling pressure; in some embodiments, a patient to which ventilation is provided in intubated; in some embodiments, the system provides ventilation to patients under sedation; in some embodiments, sedated patients are connected to the ventilation system by connecting to intubation rather than a mask;

In some embodiments, operation of the ventilation system may be performed by technicians rather than expert physicians.

The following table describes categories and features, one or more of which are included in example embodiments:

Table 4:

Reference is now made to Figure 8, which is a simplified block diagram illustration of a ventilation system 800 constructed according to an example embodiment.

Figure 8 shows one example embodiment of a ventilation system constructed around a BiPAP device. It is noted that there are other example embodiments.

Some of the components of the ventilation system in shown in Figure 8 include: a BiPAP device 802; a No Return Valve (NRV) and/or pop-off valve 804; a first pipe 806 for leading air from the BiPAP device 802; a mixer 808 for mixing air from the BiPAP device 802 and oxygen led by a second pipe

812 from an oxygen source 810; one or more additional pipe(s) 814 leading to a Non-return valve NRV 816, from which an oxygen-and-air mixture flows thru an optional AB filter 12, an optional whistle 9, an optional HME filter 8, to a tubus intubating a patient (not shown) exhaled air exiting from the patient passes through the optional HME filter 8, the optional whistle 9, the optional AB filter 12, and through one or more fitting(s) 826828 to an optional PEEP valve 830.

In some embodiments, the various connecting pipes and connectors, both reference in Figure 8 and not referenced, are standard medical pipes and connectors. Figure 8 also shows a monitor 826, which optionally monitors pressure and/or flow at one or more of the optional AB filter 12, the optional whistle 9 and the optional HME filter 8.

In some embodiments, the monitor 826 optionally includes a user interface panel 832.

Reference is now made to Figure 9A-9H, which are images of connectors and piping of a ventilation system constructed according to an example embodiment. Reference is now made to Figure 10A, which is a simplified isometric drawing of a monitor

1000 for a ventilation system constructed according to an example embodiment.

Figure 10A shows a monitor box 1002; an optional display 1004; and a pipe 1006 passing through the monitor box 1002. In some embodiments, the monitor monitors one or more parameter of flow rate and/or pressure and/or relative concentrations of gasses in a gas mixture flowing through the pipe 1006.

Reference is now additionally made to Figure 10B, which is a simplified drawing of the monitor of Figure 10 A.

Figure 10B shows the monitor box 1002; the pipe 1006 passing through the monitor box 1002; and optional monitoring pipe 1008 connected at one end to a fitting 1007, and at another end to a sensor 1014 on a Printed Circuit Board (PCB) 1010.

Figure 10B also shows one or more connector(s) 1012, optionally for communicating with an external system, optionally for providing measurements from the sensor 1014.

Reference is now additionally made to Figure IOC, which is a simplified drawing of the monitor of Figure 10 A.

Figure IOC shows the display 1004 detached from the monitor box 1002.

In some embodiments, the display 1004 is connected by wire 1020 to the monitor box 1002.

In some embodiments, the display 1004 is connected by wireless communication (not as shown in Figure IOC) to the monitor box 1002.

In some embodiments, the display 1004 is optionally a standard tablet running an application programmed for monitoring parameters of a ventilation system as described herein, and/or displaying parameters of a ventilation system as described herein.

Reference is now additionally made to Figures 10D and 10E, which are simplified illustrations of one or more PCBs in a monitor for a ventilation system constructed according to an example embodiment.

In some embodiments, a same power source powers the PCBs as the display.

In some embodiments, the display may be a tablet having its own rechargeable battery, and the PCB(s) may be powered by connecting to the tablet.

Reference is now made to Figure 11, which is a simplified illustration of a connection of one or more sensors to a gas flow pipe in a ventilation system constructed according to an example embodiment.

Reference is now made to Figure 12, which is a simplified illustration of an electronic layout scheme for a monitor in a ventilation system constructed according to an example embodiment.

In some embodiments, the monitoring unit, for example monitor 1000, or monitor 826, provides alerts, which may be visual and/or audio alerts in various situations of malfunction and/or non-standard values. Triggers for alerts, include for example, amongst others: - visual display unit malfunction (visual display unit does not display any image and/or does not turn on); recurring alerts for low pressure; recurring alerts for no breathing detected;

- blinking LED light;

- visual display unit frozen/red LED light;

- battery;

- voltage off;

LED WD blinking/whistling;

Insp/exp delta higher than 100;

- Low/high volume alert;

- Low breathing volume/ No breathing/ Low air saturation; (decrease in IPAP pressure)

- Low/high respiratory rate; (respiratory rate of the patient unstable)

Low respiratory volume; (EPAP>PEEP) (Insp time low in BIPAP)

High respiratory volume; (Insp time too high in BIPAP)

Small respiratory volume (Increase in PEEP pressure);

- High pressure (blockage in the tubing system);

- Low respiratory volume, low pressure; (tubes disconnected)

- Low respiratory volume (air leak);

- Low respiratory volume, high pressure; (blockage in the tubing system)

- High pressure; (faulty NRV, blockage)

Small respiratory volume, low pressure; (faulty NRV, escape)

- High pressure; (Defect in PEEP valve - blockage)

- Low pressure; (Defect in PEEP valve - escape)

- Low 02 pressure/low pressure/ low respiratory rate; (decrease in 02 %; 02 tubing disconnected)

- Low pressure; (tubing for pressure sampling disconnected)

- No respiration; Pressure tubing disconnected

- Low % 02; (tubing for 02 sampling disconnected)

System Malfunctioning/ Low pressure; (pressure sensor non-responsive)

System Malfunctioning/ Low saturation; (saturation sensor non-responsive)

System Malfunctioning/ % 02 erroneous; (02 sensor non-responsive)

Automatic Alert; (BPCVS system blast)

Automatic Alert; (power shortage) Automatic Alert; (Reset monitoring system)

- Low/High pressure; (patient breathing spontaneously)

- Low Breathing volume; (change on pulmonary response)

Pressure Increase/decrease, change in breathing volume; (patient awakens and rejects respirator use).

As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

The terms “comprising”, “including”, “having” and their conjugates mean “including but not limited to”.

The term “consisting of’ is intended to mean “including and limited to”.

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

As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a unit” or “at least one unit” may include a plurality of units, including combinations thereof.

The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example or “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 disclosure may include a plurality of “optional” features unless such features conflict.

Throughout this application, various embodiments of this disclosure 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 disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges 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 sub-ranges 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 (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) 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 numbers therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

It is appreciated that certain features of the disclosure, 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 disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. 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.

Various embodiments and aspects of the present disclosure as delineated hereinabove and as claimed in the claims section below find experimental support in the following examples.

EXAMPLES

Reference is now made to the following examples, which together with the above descriptions illustrate some embodiments of the disclosure in a non-limiting fashion.

Experiments were performed, comparing embodiments of a ventilating system as described herein with a commercial GE 650 Anesthesia Carestation.

The ventilating system as described herein were performed in PCV (Pressure Controlled Ventilation) mode with a BiPAP model Vivo40.

Some of the experiments were conducted without connection to a monitor module as described herein.

Several experiments were conducted with different lung simulators: a 1 liter “balloon” lung simulator; and a “puppet” lung simulator.

Several experiments were conducted by testing on an animal.

Parameters compared: oxygen concentrations at various flow rates; operation at various PEEP and PIP pressures as described elsewhere herein; operation at various respiration rates as described elsewhere herein;

Sp02 and ETC02 measured when possible; and

Ventilation pressured measured.

Summary:

The system described herein was initially tested on mechanical simulators in order to learn operational parameters.

Subsequently the system was tested on live pigs and compared to the commercial system. Each experiment tested for a different parameter and comparison was made when the parameter values gave consistent readings.

Healthy live pig experiments included:

Measuring baseline parameters at time=0;

High IPAP pressure;

High EPAP pressure;

High breaths per minute rate; and

Variable Time of inspiration (Tins).

Pathological live pig experiments included: a restrictive challenge which simulates a reduction in lung response; and an ARDS model.

Results:

Measured results for pressures, flow rate and oxygen concentration were comparable for the GE 650 Anesthesia Carestation and the embodiment of the ventilating system as described herein as performed in PCV with the BiPAP model Vivo40, in parameter ranges useful for human ventilation in PCV mode.

At tidal volumes which are beyond human lung, that is, above 1 liter tidal volume, a small difference was observed for flow rate at a given pressure - tidal volume of the ventilating system as described herein was somewhat smaller than the commercial GE 650 Anesthesia Carestation.

The ARDS model and the restrictive challenge were scenarios of severe illness, yet no significant difference was observed between the ventilating system as described herein and the commercial GE 650 Anesthesia Carestation. Gases in arterial blood were measured - both the ventilating system as described herein and the commercial GE 650 Anesthesia Carestation succeeded in keeping the animals alive, in a steady state, with similar ventilation parameter values.

Although the disclosure 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.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated 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 disclosure. 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 system for ventilating a patient with an air and oxygen mix, the system comprising: a BiPAP device; an oxygen source; and a monitoring unit for monitoring ventilation parameters.

2. The system of claim 1 wherein oxygen from the oxygen source is added to air exiting from the BiPAP device.

3. The system of claim 1 wherein oxygen from the oxygen source is added to air prior to the air entering the BiPAP device.

4. The system of claim 1 wherein oxygen from the oxygen source enters directly into the BiPAP device.

5. The system of any one of claims 1-4 wherein the monitor comprises a tablet for providing a user interface to the monitoring unit.

6. The system of any one of claims 1-5 wherein the monitoring unit is configured to monitor ventilation parameters distally along gas flow relative to the oxygen and air mix and relative to the BiPAP device.

7. The system of any one of claims 1-6 and further comprising a non-re-breathable valve.

8. The system of any one of claims 1-7 and further comprising a HMEF (Heat and Moisture Exchange) filter prior to providing air to a patient.

9. The system of any one of claims 1-6 and 8 and further comprising a PEEP valve attached to the system distal to exhaled air exiting from a patient.

10. A method for providing an air and oxygen mix, the method comprising: providing air using a BiPAP device; providing oxygen; mixing the air and the oxygen; monitoring ventilation parameters; and providing the air and oxygen mix.

11. The method of claim 10 wherein mixing the air and the oxygen is performed downstream of the BiPAP device, relative to a direction of air flow.

12. The method of claim 10 wherein mixing the air and the oxygen is performed upstream of the BiPAP device relative to a direction of air flow.

13. The method of any one of claims 10-12 and further comprising filtering exhaled air to reduce contamination.

14. The method of any one of claims 10-13 and further comprising using a non-re-breathable valve to prevent exhaled air from flowing back into system components .

15. A method of upgrading a BiPAP device to supply an air and oxygen mix as described herein.

16. A method of upgrading a BiPAP device to supply an air and oxygen mix as shown in the drawings and described herein.

17. A method of monitoring a BiPAP device when supplying an air and oxygen mix as described herein.

18. A method of monitoring a BiPAP device when supplying an air and oxygen mix as shown in the drawings and described herein.