WO2019077493A1

WO2019077493A1 - Flowmeter device for regulating manual lung ventilation

Info

Publication number: WO2019077493A1
Application number: PCT/IB2018/058014
Authority: WO
Inventors: Andrea PAGANI
Original assignee: Pagani Andrea
Priority date: 2017-10-17
Filing date: 2018-10-16
Publication date: 2019-04-25
Also published as: IT201700117302A1

Abstract

The present invention has as its reference scope the healthcare sector with particular reference to clinical equipment. In particular, this invention is aimed at a large number of potential recipients in the health sector, the invention in question is aimed at monitoring and limiting the volume and pressure insufflated during lung ventilation of a patient who needs manual respiratory support. The invention is therefore part of the health care framework of the person who is not able to spontaneously provide for breathing.

Description

Title: "Flowmeter device for regulating manual lung ventilation".

Text of the description

FIELD OF INVENTION

The present invention has as its reference field the health field with particular reference to clinical equipment.

In particular, the present invention is aimed at a large number of potential recipients in the health field, the invention in question is aimed at monitoring and limiting the volume and pressure insufflated during lung ventilation of a patient who needs manual respiratory support.

The invention is therefore part of the health care framework of the person who is not able to provide to spontaneous breathing.

The pulmonary ventilation of the patient who does not have an independent breathing capacity is usually supported mechanically by a lung ventilator or manually by a subject, usually health related, who, by compressing a special resuscitation balloon or a balloon fed with oxygen/gas flow (so called come and go or anesthesia balloon), replaces the respiratory work of the person.

PRIOR ART

The balloon, whether it is a self-expanding balloon or an anesthetic balloon, must be put in contact with the patient's respiratory system by means of a special mask that adheres to his face or by means of a tube (usually endotracheal, but also laryngeal or laryngeal mask or other appropriate devices) that isolates the airways.

The connection between the self-expanding resuscitation balloon/anesthesia ball and any device connected to it (ventilation mask, tracheal tube, mount catheter, etc.) is universal and characterized by a specific diameter so that there is no discomfort and no possibility of error or loss of time at a time of potential clinical urgency.

It is important to underline that the problems between manual and automatic ventilation are totally different, since the latter advantageously during insufflation monitor the parameters of the passage of air flow (in this case, of particular interest for the project, pressure and volume) obtaining important data on the ventilation in progress and thus allowing an optimal adaptation of the ventilation therapy to the person. One of the prerogatives of mechanical ventilation is the protection of the patient from excessive pressure or volume of insufflations.

It is precisely on the avoidance of such excesses that the device described below in this patent application is concentrated, shifting the aforementioned fineness and safety of mechanical ventilation to the coarser manual ventilation which, at the state of the art, in this sense disadvantageously it avails only of the manual skill/experience of the operator and of a mechanical overpressure valve that is pre-calibrated in the manufacturing phase.

It is observed introductively that lung capacity (the volume of air that can be contained in the lungs) varies from person to person and generally lung capacity is estimated according to age groups, sex, weight/height and respiratory diseases. The most important distinction is obviously the one that differentiates the adult from the child.

In order to reduce the risk that air/oxygen/gas is injected in excess of the patient's lung capacity (one of the most serious technical problems), there are state-of-the-art self-expandable resuscitation and anesthesia balloons of different sizes. Common commercially available are 2 It. or less (for adult patients) and 1 It. or less (for pediatricians) balloons. There are also other balloons of different volume and some of very low litrage, dedicated to the newborn.

The amount of air/oxygen/gas that is indicated to insufflate and the pressure with which this is done, in addition to what has just been specified, may also vary depending on any respiratory diseases of which the patient is affected. The insufflation of an air/oxygen/gas volume greater than a person's lung capacity and the excess pressure exerted have obvious and potentially serious traumatic consequences on the patient's respiratory system (volutrauma and/or barotrauma).

At the state of the art, in addition to the choice of a balloon of the appropriate litrage for the patient and the experience of the operator who performs the ventilation, nothing protects the patient from an excess of insufflated volume. At the state of the art, for manual ventilation, the problem of excess pressure is only mitigated by the potential presence of a mechanical valve often positioned on the junction between the balloon and the patient, which dissipates the excess pressure of the insufflation when it exceeds the limit at which it is calibrated during manufacture (this limit is frequently about 40 cm/h O).

This limit cannot be modified by the user and is therefore, disadvantageously, not adaptable to different types of patients but is intrinsic to the mounted valve. In the known art, until today insufflation in cavities of the body in general, that is, for example, the field of endoscopy, has been treated without reference to ventilation in particular, a field that, as is known to experts in the field has very specific and delicate characteristics and needs and very different from manual ventilation: for example, document WO2017/014623 describes a device intended to expose a structure within a cavity of the human body for therapeutic and/or surgical treatment. The apparatus comprises an insufflator, comprising a gas outlet and an insufflator inlet mechanism designed to inject gas from the gas outlet into the cavity of the human body, comprising in addition an insufflator control device to enlarge the part of the cavity being treated by means of gas injection from the appropriate outlet, including also a rate monitor and respiratory parameters: the insufflator control device is programmed to adapt in real time an insufflation rate and a flow in accordance with a detected respiratory rate. It also describes how the insufflator control device is also programmed to adapt in real time an insufflation rate of gas in accordance with an insufflated pulmonary pressure and/or pulmonary volume detected by a breathing controller placed invasively in the patient's body. In particular, this device, dedicated in particular to endoscopy and operations in body cavities in general, includes sensors to monitor the frequency and respiratory parameters of the patient and correlate them as mentioned above with the insufflation device.

In particular, said insufflator is not a ventilator, the insufflator is designed to act invasively in the human body to fill the cavities with air and to coordinate the insufflation of gas with the breath of the patient.

Furthermore, this device is also automatic, so it is not of interest for the scope of development of the present invention which intends to address as mentioned the lung ventilation in particular manual (which therefore does not provide for any insufflator), and its complications. Note that it is not of interest here the automatic ventilation as there are no other types of automatic insufflation similar or assimilated, the purpose of this invention is closely related and aimed at manual ventilation being a safety device and, not of secondary importance, does not provide in any case for invasion of the patient's body or its body cavities by the device or parts thereof.

BRIEF SUMMARY OF THE INVENTION

There is therefore a particular need to overcome these limits of the prior art, which have been overcome only by the skills, competences and experience of the operator who carries out manual ventilation.

One purpose of this invention is therefore to provide a regulating device suitable for manual ventilation devices that can adapt to the parameters of optimal ventilation.

A further purpose of this invention is therefore to provide an aid to the operator, even inexperienced, who has to carry out manual ventilation. It is also a purpose of this invention to describe a device that allows the same manual ventilation tool to be used on any type of patient without endangering the patient.

It is therefore a further purpose of this invention to describe a device that allows manual ventilation to be versatile and avoids the need for a number of manual ventilation devices.

These and other advantages will be obtained thanks to the innovative device object of this invention in which this device includes at least one air/oxygen/gas passage chamber in which is included at least one preferably digital flowmeter capable of measuring the air/oxygen/gas flow (in turn preferably consisting of at least one pressure detector of each insufflation and at least one volume detector of each insufflation), at least one overpressure dispersion valve, at least one excess volume blocking valve and this device includes at least one universal fitting for connecting this chamber for manual inlet ventilation, at least one universal outlet connection and at least one user/microprocessor interface (key/button/switch/etc...).

It is also an aim of the invention in a particularly advantageous way to describe a device that measures and limits according to the settings of the operator (by means of the said microprocessor) the insufflation volume, so in a completely advantageous way the device is a safety device.

This device is particularly advantageous for connecting to a resuscitation or anesthesia balloon and is positioned between it and the device(s) that are in contact with the patient (ventilation mask, tracheal tube, larynx tube, etc.). In particular, in some particularly preferred forms of production, this device shall include at least:

volume detectors (regardless of the measurement technique used) of the gaseous fluid passing through during a unit of time in a given unit of three- dimensional space;

shut-off valve (regardless of how it is mechanically constructed) that prevents the gaseous fluid from passing through a predefined path; pressure detectors (regardless of the measuring technique used) for the gaseous fluid passing through during the unit of time in a given unit of three- dimensional space;

a valve (regardless of how it is mechanically constructed) that dissipates the excess pressure of the gaseous fluid within a given volume of space;

a microprocessor responsible for managing the flow data of the gaseous fluid and for managing the elements that determine it (including the said valves); buttons or equivalent means to set the limits of the structure that can be connected to the ventilation devices;

and in some particularly preferred forms of realization at least one display that is responsible for the graphical and numerical representation of the flows and limits of these;

universal fittings for the flow in and out of the device.

The invention has the advantage of correcting excess volume and/or pressure manually insufflated by means of special valves mentioned above, controlled by a microprocessor set according to limits decided by the user, so as not to exceed values that otherwise could cause damage to the respiratory system of the patient.

The use of the device, as an obvious advantage, would allow the use of an adult resuscitation balloon also for the manual ventilation of a child (even very small) and for the ventilation of patients with respiratory diseases that affect their lung capacity. The result is a potential reduction in the equipment of emergency or hospital means, since the device makes it ideal to replace the pediatric and neonatal balloons with a single balloon, for example, with a maximum volume of litres.

The invention in a further advantageous way allows to guarantee adequate manual ventilation even if the person who has to provide it lacks experience and skills, or if it must be guaranteed in conditions of movement (perhaps even on difficult terrain - typical in extra-hospital rescue) that reduce the attention to the fineness of manual ventilation. A further advantage of the invention in one of its preferred forms of realization includes the possibility of using the device itself also in the field of training of operators who can learn the relationship between the compression of the balloon and the volumes and pressures generated by it when numerically/graphically indicated by it (as in the following description of the detail).

The device covered by this application consists of a potentially (but not necessarily) plastic body containing, within the air/oxygen/gas passage chamber, the mechanism for measuring the parameters (in particular volume and pressure) of the air/oxygen/gas flow, which is connected to a microprocessor/CPU programmed to monitor and control the flow of fluid (air/oxygen/gas) which is in turn connected to at least one valve (which it controls) designed to interrupt the flow to the patient that closes, preventing an excess of volume at the outlet, and at least one other valve (which it controls) which instead opens outwards, dissipating the excess pressure according to the settings of the limits decided by the user. All these connections are preferably of the wire type.

The valves mentioned here are suitable to communicate with the microprocessor and to be controlled by it.

The valve that prevents the volume of excess air/oxygen/gas from escaping from the invention (and its consequent entry into the patient's respiratory shaft in harmful and incongruous quantities) if the user's insufflation has exceeded the set limits, is preferably made up of at least one diaphragm that closes on command of at least one microprocessor, such as a shutter or any physical barrier that blocks the passage on command of the microprocessor/CPU.

At least one valve that dissipates the excess pressure of the insufflation (and its consequent inlet with harmful incongruous pressure in the respiratory shaft of the patient if the insufflation operated by the user should have exceeded the set limits) is preferably made up of at least one diaphragm that opens on command of the microprocessor, such as at least one shutter, both for example with allowed positions of "open'V'closed" only and with modulable opening on command of the microprocessor/CPU.

In an alternative form of realization of the invention, the function of these valves can also be performed by a single valve conformed for this purpose. The body of the device is characterized by the presence on two of its sides (preferably, but not necessarily, on the opposite sides) of universal/standardized fittings (also preferably, but not necessarily, made of plastic/PVC) for the air/oxygen/gas flow at the inlet and for the air/oxygen/gas flow at the outlet. The inlet flow fitting for the instrument univocally adapts to the outlet flow fitting for the resuscitation balloon (of any type) and the outlet flow fitting for the innovative device adapts flexibly to the fitting of masks, tubes and any other intermediate device/guards that interposes between the device and the patient.

The device, since the said fittings are universal, can also be connected to mechanical ventilation devices such as lung ventilators.

The fittings mentioned here are preferably universal connectors, e.g. type 22/15mm (ISO). The 22mm (ISO) male is the preferred connection between the device and the balloon, while the 15mm (ISO) female between the device and the device(s) separating it from the patient. These types are merely examples and are not intended to limit the scope of protection of the present invention in any way.

Different fitting configurations can be designed with adapters to these universal fittings without changing the scope of protection or affecting the peculiarities of the invention.

The technical specifications of the fittings are not covered by this application and the applicant of the application has no claim to them.

The specific position of the connectors on the surface of the device does not discriminate between its nature or its peculiarities.

The shape of the connectors (e.g. linear or angled) does not limit the peculiarities of the invention but only changes the aesthetics of the same, or can advantageously improve the handling of its use. Even the size of the device does not limit the scope of protection of the present invention, even if the smaller they are, the more handy and comfortable the use of the device will be.

The mechanism or flowmeter with which the device measures the flow and therefore the volume and/or pressure of the air/oxygen/gas that passes through it inside the appropriate passage chamber at each insufflation produced by the operator is preferably made up of a propeller/turbine or anemometer mechanism whose rotation is passively caused by the passage of the air/oxygen/gas due to the manual compression of the balloon and whose data are collected and analyzed by the microprocessor connected to it and programmed for this purpose. Integrated or added to the anemometer is the device for detecting the pressure (manometer) of the gaseous fluid produced by the compression of the balloon.

In an alternative form of construction, the flowmeter with which the device measures the parameters of the passage of the air/oxygen/gas inside it, deducing the volumes, the speeds (and potentially, for indirect measurement, the pressures) of the insufflations can be a "hot wire flowmeter".

In an alternative form of construction, the flowmeter with which the device measures the parameters of the passage of air/oxygen/gas inside it, deducing the volumes, velocities and pressures of the insufflations, may include a "Pitot tube".

In an alternative embodiment form, the flowmeter with which the device measures the parameters of the air/oxygen/gas passage inside it, deducing the volumes and pressures of the insufflations, may include a " Venturi tube". In an alternative embodiment form, the flowmeter with which the device measures the parameters of the air/oxygen/gas passage inside it, deducing the pressures and volumes of the insufflations, may include a "differential pressure gauge" or "calibrated orifice" or "diaphragm".

These measurement technologies are intended to be non-exclusive or exhaustive sense and are described as a mere example not limiting the present invention. The microprocessor must be programmable by the user so that he can set a volume limit and/or, in the same way, air/oxygen/gas pressure of the single insufflation beyond which it acts on said at least one or more valves in order to correct any excess produced by the person who is manually ventilating the patient.

In case the insufflated volume (in each individual insufflation) reaches the volume limit set by the user, the valve that allows the passage of the air/oxygen/gas towards the patient will be closed; while in case the maximum pressure set by the user is reached (too strong insufflation), the valve that allows the excess pressure to be dissipated will be opened, preferably towards the outside of the device body.

The microprocessor, in order to interface with the user, can preferably be equipped with at least one display/monitor and with buttons accessible to the operator through which (in addition to switching the instrument on and off) the operator will decide the flow limits that the invention must prevent from being exceeded.

To this end, some passages of a particularly suitable and useful method for the regulation of the microprocessor and of the passages necessary for the control actions of the parameters of the present invention are attached; this method and its variations will be described with reference to the attached figures.

It is conceivable that the display can also be configured to provide continuous instantaneous values or the graphical representation of the flow parameters (which can be advantageous for use of the device in education).

It is conceivable that the display is illuminated if the device is used in a poorly lit environment.

The possibilities of conceiving the device and the possibilities of setting the above limits can be achieved in different ways depending on the subject or the area for which each possible different form of implementation is intended. Since the identification of the volume of air/oxygen/gas to be injected into the patient's respiratory system is an exclusively medical act, the device can be conceived in an "advanced" form if it is intended for the hospital/medical environment, i.e. for example with the possibility of finely setting the volume limits (e.g. expressed in ml.) and pressure limits (e.g. expressed in mm/Hg or cm/h O) and it is also possible to foresee the possibility of exceeding these limits without activating an automatic correction by means of the valve(s) but simply by means of an audio alarm and a notice on the display. Again, in a more simplified form of implementation, intended for example for the world of rescue associations (formed mainly by non-health personnel, often voluntary and potentially inexperienced), it can be expected that the device can be set, for example, on pre-set limits relating to age or weight, or, even more simply on categories that can potentially be made up of "adult", "pediatric", "infant". The lay/non-expert rescuer should in this case exercise a choice (by means of a button, switch, key or alternative method) between two or three possibilities, in the same way in which now, in the absence of the device in question, he exercises the choice between the use of the adult balloon and the pediatric balloon, but in a particularly advantageous way having a single compact instrument available that can adapt to any situation.

The purpose of the invention includes any intermediate form of "complexity" that it intermediate between those described above.

It is preferable for the device to be equipped with a power button/switch.

The device operates preferably with power supply preferably with batteries voltage between 1.2V and 12V. It is also conceivable that the device is equipped with a rechargeable battery, as it is conceivable that it is powered by domestic electricity (with an energy transformer).

Battery power requires an alarm/low battery signal.

It is foreseen that the device, in the absence of a power supply or in the case of a discharged battery, can still be used without it being able to actively intervene on the airflow, but that it is limited to allowing it to pass freely through the device without compromising the possibility of ventilation; that is, it is preferable that the valve designed to prevent the excess of insufflated volume be in the "open" position in the absence of a power source. The man-object interaction is realized as follows: the user switches on the device and applies it between the self-expanding resuscitation balloon (or anesthesia balloon) and the ventilation device (mask, tracheal tube, etc.) by means of the universal fittings; he sets the volume/pressure limits that he does not want to be exceeded during each air/oxygen/gas insufflation to the patient and ventilates the patient by compressing the balloon. The device will prevent the set parameters from being exceeded through flow monitoring and valve action. A variant of the device provides that when the set air/oxygen/gas flow limits are reached, a warning light and/or sound is associated.

Further features and advantages of the invention will be further clarified by the detailed description of some preferred, but not exclusive, forms of realization of a device for controlling the insufflation volume and pressure according to the present invention. DETAILED DESCRIPTION OF SOME FORMS OF REALIZATION OF THE PRESENT INVENTION

The present invention will be better specified in terms of purposes and advantages by the following description of a preferred form of realization, illustrated purely by way of example and not limited with reference to the attached drawings in which

in fig. 1 is represented a preferred form of realization of the device described by the present invention;

Fig. 2 shows a detailed diagram of the innovative device according to a particularly preferred form of realization of the present invention;

and in fig. 3 another form of realization is described.

Figures 1 and 2 essentially show the system composed of a self-expanding balloon (or for anesthesia) 1 , the device 100 comprising at least a flowmeter, pressure 7 and volume 6 detectors - of which these first elements inside an airflow/02/gas passage chamber 15 - and at least a microprocessor 10 - external to said chamber 15, but internal to said device 100; in particular on at least one external side of said device 100 there is at least one display/monitor 14 for data visualization, there are further at least valves for example of at least extra volume 8 and excess pressure 9. There are also, for purely functional purposes, setting buttons 13, at least one energy source 16 or connections to at least one energy source and at least universal fittings 3 and 19 to connect this device to at least one ventilation balloon or ventilation device 1 and to means such as at least one ventilation mask 5 or any device to be placed between the balloon and the patient with its universal fittings mentioned above such as 2, 3, 19 and 20.

Figure 2 shows the device 100 in detail, outlining its components both inside the air/oxygen/gas insufflated passage chamber from the balloon to the patient, and outside it, i.e. microprocessor 10, any other components that will be specified below, and at least one user interface 1 1 , (which is preferably positioned on an external surface of the device).

In particular, figure 1 shows the device 100 connected to a device 1 such as an auto-expandable balloon 1 which can also be an anesthesia balloon or in any case a device for the artificial ventilation of the patient who does not have sufficient autonomous respiratory activity. One side of the balloon 1 facing the device 100 is normally equipped with a universal female fitting 2, normally 22mm (ISO), this fitting is preferably connected to a compatible universal male fitting 3, normally 22mm (ISO), for example, located on the input side of the device 100. On the opposite side of the device 100 there is preferably another female universal fitting 19, for example 15mm (ISO). This fitting allows the connection with a male fitting 20 of the 15mm (ISO) 5 or other device that is placed between the device 100 and the patient who connects to the same fitting. In Figure 2, on the body of the device 100, in particular on its external surface 1 1 , at least one display/monitor 14 and buttons 13 intended for interaction with the user (on/off 12, volume and/or insufflation pressure limit settings, etc.) are visible.

Figure 2 shows the device 100 specifically for its components in a particularly preferred form of realization. The device 100 includes at least one insufflated air passage chamber 15 which is delimited at its ends by the universal male/female fittings 22/15mm (ISO) 3 and 19, preferably connecting it on one side (insufflated air inlet) preferably to a self-expanding or anesthesia balloon and on the other side to the ventilation device (e.g. ventilation mask) or to any other device between the device and the patient (e.g. mount catheter). At least one flowmeter 4 is positioned at the inlet or, in any case, inside the air passage chamber 15 and is composed of at least the air flow detectors potentially split into an insufflated volume detector 6 and an insufflated pressure detector 7 (which preferably work according to the method and modes described below), conceptually represented as two distinct entities but which could also be constituted by a single instrument/means. These detectors preferably send the data collected to a dedicated microprocessor/CPU 10, equipped with relative software for the recognition and processing of the same, which in practice implements the method to be described herein. At least one microprocessor 10 acts on the described valve plug 8 closing it if the maximum limit of insufflated volume set by the user has been reached (thus preventing the continuation of the insufflation) and on the described valve vent 9 modulating the opening towards the outside if the maximum limit of insufflation pressure set by the user has been reached. These limit parameters are set by the user, who interacts with the appropriate keypad 13 and display/monitor 14 and who is preferably located accessible on the external surface 1 1 of the device 100. Potentially on one side can be clearly visible an On/Off button 12 in turn located on the external surface 1 1 of the device 100. It is possible to imagine a physical protection for the keys better if slim and not cumbersome, this obviously taking nothing away from the scope of protection of this invention.

The connection between the device and a power source 16, which can preferably be found in one or more batteries with a voltage between 1 .2V and 12V, as well as the connection between the various elements of the device is preferably made by connecting it with a cable. This cable is preferably equipped with two different wire elements, i.e. a positive and a negative pole. If necessary, a power transformer may also be present between the device and the power source, if this is not identified in the batteries.

When the air/oxygen/gas volume limit is reached, it is possible to provide an acoustic warning by means of a relative warning device 17 and/or a luminous warning device by means of a relative light source (e.g. LED) 18; everything will obviously be managed by microprocessor 10.

Fittings 3 and 19 can be either linear or curved (e.g. elbow shape) if configuration requirements so require.

Finally, in fig. 3 is represented an alternative form of realization of the innovative device described by this invention as an example, (this realization does not change the scope of protection of the invention), which includes a display/monitor 14 with user interface 21 , positioned externally from the device (with the possibility of adjusting the settings/choice of the type of patient also via touch screen), this display/monitor is connected for example by wire, or through RFID connection, Wi-Fi, etc.. with the device 100 to communicate with that device, but is not physically part of it and is advantageously positioned at the discretion of the user.

Such a variant may include a graphical user interaction module integrated, for example, in a multiparameter monitor monitoring the clinical parameters of the patient of any type, provided that it is enabled for interaction with that device. The body of the display/monitor can therefore be conveniently placed in any position preferred by the user.

This most elaborate form of construction is the one that lends itself best to the use of the device for the purpose of precise monitoring of manual ventilation, and also that lends itself best for educational purposes for the special attention it pays to the graphic/parameter aspect of the representation of insufflation. This form of implementation is one of those that is most suitable to be equipped with event memory, (e.g. on internal memory or connectable hardware support or cloud or equivalent), for example integrated into the device and/or display and/or interaction module These data can also be downloaded and/or sent remotely for archiving and use, for example, for subsequent analysis (e.g. for both teaching and diagnostic purposes). It is concluded that advantageously said device by automatically limiting the volume of insufflation is suitable for any type of device 1 , both for adult, pediatric and neonatal patients.

Moreover, in an even more advantageous way, this device, automatically limiting the volume of insufflation, is suitable for any type of operator, even inexperienced ones, and for any type of operating situation.

The shape and size of the device shall not discriminate on its conceptual peculiarities.

As far as a possible method for the management and operation of the innovative device is concerned, implemented by at least one microprocessor, (this does not imply the treatment of a patient, but only indicates the possible operation and possible settings of the machine), the following is observed:

- monitoring by the relative detector of the parameter A = volume of the gaseous fluid of the single insufflation

- monitoring by the relative detector of the parameter B = pressure of the gaseous fluid of the single insufflation;

- data processing A;

- data processing B;

- instantaneous graphic and/or numerical representation of A

and/or B - optional;

- setting, for example, by the user of the upper and possibly lower limits of parameter A;

- setting, for example, by the user of the upper and possibly lower limits of parameter B;

- comparison of instantaneous parameter A with its limits;

- comparison of the instantaneous parameter B with its limits; - action occurs on a valve that occludes the passage of air in the direction of exit from the device when the upper limit of parameter A is exceeded;

- action occurs on the valve that dissipates the excess pressure outside the gas path towards the exit from the device when the upper limit of parameter B is exceeded;

- If at least one of the limits A and/or B is exceeded, at least one audible and/or visual alarm can be associated (but is not necessary).

Therefore substantially: at least one microprocessor, taking into account A and B and the limits set for them, continuously compares them with the data of instantaneous pressure and instantaneous volume of air/02/gas passing through the chamber/pipeline inside the device supplied by the relative detectors and, by monitoring the parameter B, on the basis of these data, it is possible to recognize any insufflation produced by the user and C - or the microprocessor - returns the said data in numerical terms and, if necessary, also with a graph on the display/monitor.

Microprocessor C receives as input from the user the volume limit D and/or the pressure limit E which the insufflation must not exceed and compares them continuously with the relevant instantaneous data.

If at least one of these limits is reached, microprocessor C prevents it from being exceeded by acting on the relative valve, preventing excess volume from passing through the patient's respiratory system or dissipating excess pressure, preferably outside the device.

When at least one of the limits D and/or E is reached, it associates a luminous/visual warning (potentially it is only a message on the display) or a sound warning.

In conclusion, it should be noted that this method is described as an example of microprocessor control useful for the purpose of the present invention, therefore modifications in this direction are contemplated and will be mere variants useful for the purpose of the present invention. In fact, the embodiment described here is only an exemplary form of realization of implementation of the method of control implemented for the innovative device described by the present invention, any variant in this sense is understood to be included in the object of the present invention. Note further that this method only describes the operation in a possible variant of the device and does not describe a treatment for a patient's body.

It should be noted, therefore, that the innovative device with flowmeter function to regulate (volume and/or pressure limitation) the manual pulmonary ventilation described in this invention allows to achieve all the purposes described above; moreover, in an even more advantageous way, the patient will receive a more adequate and stable ventilatory assistance even while travelling, for example, in an ambulance or rescue vehicle or helicopter, etc. this also regardless of the type of road surface, even if not linear or impassable (which normally facilitates ventilation inaccuracies).

Variations in size and shape of the device, material in which the various parts are made, external aesthetic or functional aspect of the device, as the presence of a display/monitor, or more than one display/monitor, presence or shape of buttons on the external side of the device or in a separate location of any remote control, variations in physical parts not substantially useful to vary the use of the innovative device and more are to be considered embodiment forms all included in the object of this invention as better described by the attached claims.

Claims

1. Device with flow meter function (100) suitable for adjusting pulmonary manual ventilation, comprising at least one air/oxygen/gas passage chamber (15) comprising at least one preferably digital flowmeter (4) for measuring the air flow/oxygen/gas entering the chamber, said flowmeter comprising at least one pressure detector (7) of each insufflation and at least one volume detector (6) of each insufflation, said device further comprising at least one valve (9) for overpressure dispersion, at least one volume overflow shut-off valve (8), said valves (8, 9) being controlled by a microprocessor (10) suitable for measuring and limiting and controlling at least the volume of insufflation for a patient by means of said valves of said device (100) according at least to operator's settings, said device being therefore a security device.

2. Device with flow meter function (100) according to claim 1 , comprising at least one universal fitting (3) for connecting said device (100) for manual ventilation in inlet to a suitable ventilation mean (1 ) and at least one universal outlet fitting (19) to connect at least to a suitable mean (5) to ventilate a patient.

3. Device with flow meter function (100) according to the preceding claims, wherein said at least one ventilation mean suitable for the purpose (1 ) is a resuscitating or anesthetic balloon and said at least one mean (5) suitable for a patient is a mask for ventilation, a tracheal, laryngeal or similar tube, said device (100) being adapted to regulate ventilation connected to any medical supplies suitable for manual ventilation.

4. Device with flow meter function (100) according to the preceding claims, comprising at least one user interface (11 ) for setting parameters for adjusting said microprocessor (10).

5. Device with flow meter function (100) according to the preceding claims, wherein said user interface (1 1 ) comprises at least one display (14), a keyboard (13) for interacting with the user, and means such as at least one switch (12), and warning means (17) and/or warning lights (18).

6. Device with flow meter function (100) according to the preceding claims, wherein said device comprises at least one power supply such as a battery or can be connected to various energy/power sources (16).

7. Device with flow meter function (100) according to the preceding claims, wherein said device automatically limiting the volume and/or the pressure of the insufflation is suitable for any type of insufflation mean (1 ) for both adult and pediatric patients and neonatological patients.

8. Device with flow meter function (100) according to the preceding claims, wherein said device automatically limiting the volume and/or the pressure of the insufflation is suitable for any type of operator also inexperienced and to any type of operating situation.

9. Device with flow meter function (100) according to the preceding claims, wherein said flowmeter (4) may be a hot wire flowmeter or may comprise at least one Pitot tube or a Venturi tube or differential pressure meter or being a calibrated orifice or diaphragm, or an anemometer or other means adapted for that purpose.

10. Method for managing the device (100), implemented by a microprocessor (10), having at least the steps of:

- monitoring by a relative detector of a parameter A = volume of the single- injected gas fluid;

- monitoring by relative detector of a parameter B = pressure of the gaseous fluid of the single insufflation;

- processing of data A;

- processing of data B;

- instantaneous graphic and/or numerical representation - A and/or B - optional;

- setting of the upper limits and eventually lower limits of parameter A i.e. by the user;

- setting of the upper limits and eventually lower limits of parameter B i.e. by the user;

- comparison of the instantaneous parameter A with its limits;

1 1 . Device with flowmeter function (100) according to the previous claims, which includes a display/monitor (14) with user interface (21 ), located externally by the device, said display/monitor (14) being connected by wire, or by RFID connection, Wi-Fi, or other suitable connection for the purpose with the device (100) to interact with it, said display/monitor (14) being positioned at the discretion of the user.

12. Device with flowmeter function (100) according to the previous claims, in which the adjustment of the settings/choice of the type of patient of the display/monitor (14) is done via touch screen.

13. Device with flowmeter function (100) according to the previous claims, which includes a user interaction module integrated in a multiparameter monitor for monitoring clinical parameters of the patient of any type as long as it is enabled for interaction with said device.

14. Device with flowmeter function (100) according to the previous claims, in which the device and/or the display and/or the interaction module is equipped with an event memory on an internal memory or connectable hardware support or cloud or equivalent, the data can be further downloaded and/or sent remotely to be stored and used later for analysis, both for educational and possibly diagnostic purposes.