IT202000011017A1 - METHOD OF EXECUTION OF SPIROMETRY AND SYSTEM FOR THE REALIZATION OF THE SAID METHOD - Google Patents

Description

DESCRIPTION

METHOD OF PERFORMING SPIROMETRY AND SYSTEM FOR THE REALIZATION OF THE SAID METHOD

The present invention relates to a method of carrying out spirometry and a system for carrying out said method of spirometry of the type specified in the preamble of the first claim.

In particular, the present invention relates to an execution method and related system capable of ensuring the correct and safe performance of the operations foreseen for spirometric investigations with particular attention to contamination between different users who use the same spirometric apparatus. As known, spirometers are instruments used to measure a user's lung volumes.

Conventional spirometers are, therefore, composed of a sensor connected to a mouthpiece and a part that measures the movements of air caused by the user who inhales and exhales through the sensor over a specified period of time.

The sensor can? be made up of various elements depending on the type of spirometer used.

Spirometers pi? widespread include a turbine sensor and are configured in such a way that the volume of air mobilized is reconstructed based on the measurement of the flow, in turn calculated through an electronic measurement of the rotation of the turbine blade of the spirometer. This rotation, pi? or less intense? precisely generated by the inhalation and exhalation of the user.

Such spirometers are called ?flow? or ?flowmeters?.

The spirometer? one of the fundamental equipment for functionality tests? respiratory. It is, in fact, a very effective and widespread, non-invasive and well-standardized diagnostic tool, frequently used in the diagnosis and evaluation of the functionalities of the body. lung disease in people with airway restrictive or obstructive diseases such as asthma, bronchitis, and emphysema.

In particular, these spirometers are widely used in occupational medicine and in competitive and non-competitive sports visits.

As sadly known, the COVID-19 epidemic currently underway has shown particular criticality on the airways of people affected by the virus. Furthermore, at the same time, the epidemic has shown a high diffusion coefficient mainly due to the transmissivity? of the virus by air.

Therefore, the epidemic has highlighted the need to provide for the sanitization of all the instruments in contact with the users' airways and, naturally, also with the spirometers.

At present, in order to guarantee an acceptable level of safety for continuous use and over several? subjects of the same spirometer, ? necessary to replace the mouthpiece and the turbine at each spirometric analysis.

The snorkel? a relatively simple and cheap element, therefore ? simple to replace this element at each exam.

However, an important drawback of spirometers, and therefore of the methods adopted for spirometry, is what the turbines or, more? in general, the sensors used are not as interchangeable.

In particular, these sensors have relatively high costs and are difficult to remove from the device. Therefore, in order to set up a series of subsequent exams ? it is necessary to foresee some time for disassembling and assembling the spirometer. Furthermore, even if disposable turbines are used, all the contaminated material must be disposed of, constituting large quantities of waste. waste.

By envisaging the use of antiviral filters to protect the turbine, current spirometers can present reductions in efficiency since the filtering material of the antiviral filters does not always allow a true reading of the parameters. In particular, with very weak air flows, you never have the precision you would have with an unobstructed mouthpiece.

In conclusion, the conduct of current spirometry does not even exclude the possibility that the handle itself is contaminated with obvious risks in terms of health for the various users who use the same spirometer.

In this situation, the technical task underlying the present invention? devising a spirometry execution method and system for carrying out said spirometry method capable of substantially obviating at least part of the aforementioned drawbacks.

In the context of this technical task ? an important object of the invention is to obtain a spirometry execution method and related system capable of avoiding the continuous disassembly and assembly of the spirometer in order to replace the sensor for detecting the air volume.

Another important purpose of the invention ? create a method of execution of spirometry and related system that allows you to carry out a series of spirometric tests in sequence with great rapidity? and economy.

Furthermore, a further task of the invention is create a method of performing spirometry and related system that is really safe and significantly reduces the chances of contamination between successive users.

In conclusion, a further aim of the invention is achieve a method of performing spirometry and related system that is highly safe, but at the same time highly efficient.

The specified technical task and aims are achieved by a method of performing spirometry, and related system, as claimed in the annexed claim 1. Preferred technical solutions are highlighted in the dependent claims.

The characteristics and advantages of the invention are clarified below by the detailed description of preferred embodiments of the invention, with reference to the attached drawings, in which:

Fig. 1 shows a system for realizing a method of performing spirometry according to the invention;

Fig. 2 illustrates a diagram of a system for realizing a spirometry execution method according to the invention in which the sanitization apparatus is sectioned to highlight the various components;

the Fig. 3a ? a diagram of a system for realizing a method of performing spirometry according to the invention in which the sanitization apparatus is integrated in the spirometry apparatus and defines the processing device and the spirometer ? answered, at rest, in the wrapper; And

Fig.3b represents a diagram of a system for realizing a spirometry execution method according to the invention in which the sanitization apparatus ? integrated in the spirometry apparatus and defines the processing device and the spirometer ? extracted, in use, from the casing.

In this document, measurements, values, shapes and geometric references (such as perpendicularity and parallelism), when associated with words such as "about" or other similar terms such as "almost?" or "substantially", are to be understood as less than measurement errors or inaccuracies due to production and/or manufacturing errors and, above all, less than a slight deviation from the value, measure, shape or geometric reference to which ? associated. For example, these terms, if associated with a value, preferably indicate a deviation of no more than 10% of the value itself.

Also, when used, terms such as ?first?, ?second?, ?superior?, ?inferior?, ?main? and ?secondary? do not necessarily identify an order, a priority? of relationship or relative position, but can simply be used for pi? clearly distinguish between different components.

Unless otherwise specified, as apparent from the following discussions, terms such as "processing", "computing", "determination", "computing", or the like are understood to refer to the action and/or processes of a computer or similar electronic calculation that manipulates and / or transforms data represented as physical, such as electronic quantities of registers of a computer system and / or memories in, other data similarly represented as quantities? in computer systems, logs or other devices for storing, transmitting or displaying information.

The measurements and data reported in this text are to be considered, unless otherwise indicated, as performed in an ICAO International Standard Atmosphere (ISO 2533:1975).

With reference to the Figures, the system for carrying out the spirometry execution method according to the invention ? globally indicated with the number 1.

System 1? preferably portable and allows you to carry out spirometric analyzes in any context.

The system 1 essentially comprises at least one spirometer 2 and at least one sanitization apparatus 5.

Of course, system 1 could also include a plurality of of spirometers 2 and/or a plurality? of sanitation devices 5.

Spirometer 2 ? substantially a device well known in the current state of the art. Preferably, spirometer 2 ? preferably a widely used spirometer, such as a flowmeter.

In general, spirometer 2 ? configured to allow measurement of air displacement.

Substantially, therefore, the spirometer 2 preferably comprises at least one handle 20 and detection means 21.

The handle 20 ? an elongated element configured to allow the flowmeter 2 to be gripped by a user.

The detection means 21 are preferably configured to detect the volume of air or the flow or the quantity? of air passing through it.

Substantially, the sensing means 21 comprises a tubular component or mouthpiece within which ? including a turbine.

An example of such a spirometer 2 is, for example, the Pony FX spirometer marketed by COSMED.

The spirometer 2 can therefore include in the handle 20 all the means necessary for processing the information detected by the detection means 21. Therefore, the handle 20 can include an electronic board and possibly interface devices capable of allowing communication between the handle 20 and objects not mechanically connected to the handle 20.

Spirometer 2 can therefore define a complete spirometry apparatus 8, or, as in the case of the Pony FX spirometer marketed by COSMED, it can be included in a spirometry apparatus 8 pi? complex.

The spirometry apparatus 8, as shown in Figs.1-2, can in fact including, in addition to the spirometer 2, also a processing device 6 and connection means 7.

If present, processing device 6 can? include electronic elements suitable for allowing the control or command of the operation of the spirometer 2.

The connection means 7 are preferably able to operatively connect the processing device 6 and the spirometer 2. The connection means 7 can therefore be means of the wireless type arranged partly within the processing device 6 and partly within the spirometer 2 .

Or, the connection means 7 may include, as shown in Figs. 1-2, a physical connection element, such as a cable, preferably removable with respect to the handle 20.

In this sense, the handle 20 preferably includes a connector capable of allowing the connection or disconnection of the connection means 7 as desired. previously mentioned, the processing device 6 pu? substantially be integrated in the handle 20.

In addition, on spirometer 2 pu? be bound at least a first nozzle 3. The first nozzle 3 ? substantially a removable one with respect to the spirometer 2. In other words, the mouthpiece 3 ? a disposable element which can be attached to the spirometer 2 to carry out a single air measurement for a single user.

Therefore, other mouthpieces can be attached to the spirometer 2. On spirometer 2, in particular, ? at least one second nozzle 4 can be linked. The second nozzle 4 ? also substantially removable from the spirometer 2. The second mouthpiece 4 is, therefore, of the same type as the first mouthpiece 3, ie disposable. This does not mean that the first nozzle 3 and second nozzle 4 are identical. In fact, they can be different, but both essentially have the characteristic of being removable and disposable.

Naturally, the nozzles 3, 4 are preferably made of cheap materials, for example resin-coated cardboard, and have characteristics known to the person skilled in the art. Furthermore, before use, the mouthpieces 3, 4 are preferably kept inside sealed containers to ensure that they are sterilised.

Therefore, a spirometry apparatus 8 can? include, as a whole, in use, the spirometer 2, the processing device 6, the connection means 7 and one or more? mouthpieces 3, 4.

The sanitization apparatus 5 ? substantially configured to sanitize at least the spirometer 2. This sanitization preferably takes place by sterilizing with ozone, or by ozonizing, at least the spirometer 2.

In this way, can be eliminated any impurity? on the spirometer 2. With impurities? means all those harmful elements that can endanger the health of the user including, for example, bacteria or viruses or similar.

Therefore, preferably, the sanitization apparatus comprises at least one ozonizer 55. The ozonizer 55 is a device widely known in the current state of the art. In particular, it collaborates with other elements of the sanitizing apparatus 5 in order to allow the sanitization of at least the spirometer 2 or of the spirometric apparatus 8 or of a plurality of of spirometers 2.

In order to carry out the sanitization, the sanitization apparatus 5 in fact includes a casing 50. Naturally, the ozonizer 55 is preferably placed in a fluid passage connection with the casing 50 in such a way as to be able to make the ozone flow into the casing 50 on command.

The enclosure 50 defines an internal volume configured to allow the housing of at least the spirometer 2. Even more? in detail, in a preferred embodiment, the casing 50 defines a volume such as to allow the insertion of a single spirometer 2. This embodiment? more portable.

However, for efficiency reasons, casing 5 can? be configured to house a plurality? of spirometers 2. For example, in this sense, the casing 50 could include housings for even more? of a spirometer 2 and also for any auxiliary devices, such as spirometry nose clips. In addition, the casing 50 can? also be configured to be able to house at least an entire spirometry apparatus 8, preferably without the mouthpieces 3, 4, the latter being preferably disposable.

The enclosure 50 could, for example, have dimensions comparable to the chamber of a common microwave oven.

Furthermore, the sanitizing apparatus 5 could be configured to integrate the spirometry apparatus 8. In this sense, preferably, the sanitizing apparatus 5 could include the processing device 6 and the connection means 7 inside itself.

The connection means 7, in particular, could be included, at least in part, in the casing 50 and be configured in such a way as to be extractable at least in part from the casing 50 so as to allow the spirometer 2 to be extracted or retracted from the ?casing 50.

In other words, the spirometry apparatus 8 comprises a spirometer 2 included in a sanitation apparatus 5 acting as a processing device 6 and extractable from the casing 50 of the sanitation apparatus 5, for use, thanks to the connection means 7 , as shown in 3a-3b. Substantially, the spirometry apparatus 8 would be configured to keep the spirometer 2 responding inside the sanitizing device 5 when the spirometer is not? in use. This configuration? especially preferable for systems 1 of the portable type.

The sanitizing apparatus 5 preferably includes further elements suitable for allowing and/or improving the implementation of the method according to the invention.

Preferably, the sanitizing apparatus 5 comprises sensor means 51.

The sensor means 51 are preferably configured to detect the quantity? volumetric analysis of ozone inside the casing 50. Sensor means 51 of this kind can be of various types and can use technologies widely known in the current state of the art.

In addition, the sanitizing apparatus 5 comprises control means 52.

The control means 52 is preferably configured at least to compare the quantity? volumetric of ozone with the internal volume. This comparison has the purpose of allowing the determination of an effective percentage value of ozone inside the enclosure 50.

Furthermore, having detected the effective percentage value, ? You can determine when the actual percentage value reaches a threshold percentage value. The threshold percentage value? a saturation value of the casing 50 that can? be substantially predetermined. The determination can be, therefore, definable by the user or not.

In order to allow the setting of the threshold percentage value, the sanitization apparatus 5 can? include control means 54.

The command means 54, therefore, are preferably operatively connected to the said control means 52. The command means 54 can be configured, as already said, to allow you to set the threshold percentage value. Furthermore, additionally or alternatively, they can be configured to allow the user to vary a volumetric flow rate of introduction of the ozone into the enclosure 50.

The range? otherwise? defined, as known, as the relationship between the quantity? volumetric measurement of ozone and a time for the ozone to enter the casing 50.

Naturally, preferably, the control means 54 are also operatively connected to the ozonator 55 in such a way as to be able to allow a user to determine the volumetric flow rate.

In addition, the control means 54 could also include wireless devices, configured to communicate with other external devices such as smartphones, tablets, PCs or even printers for printing information relating to sanitation.

The control means 54 and the control means 52 could together realize the control elements of the processing device 6 if the latter is included in the sanitizing device 5.

The apparatus therefore comprises a vent valve 56.

The vent valve 56, also known in the current state of the art, is preferably placed in a fluid passage connection with the casing 50.

Mainly, the vent valve 56 ? configured to evacuate the ozone from the enclosure 50, in particular when it is? at least the spirometer has been sanitized 2.

In conclusion, the sanitization apparatus 5 comprises means of notification 53.

The notification means 53 is preferably configured to notify the user that the actual percentage value has reached the threshold percentage value.

In other words, the notification means 53 notify the end of the sanitization to the user in such a way that the latter is notified of the occurred sanitization in order to be able to extract the spirometer 2 or the spirometric apparatus 8 from the casing 50.

Examples of notification means 53 can be acoustic or visual signals or alarms, for example flashing LEDs, or the like.

In order to ensure safety, 1 system could include 9 safety means.

If present, the safety means 9 are configured to lock at least the spirometer 2 at the end of a spirometry on a user and configured to unlock the spirometer 2 when the sanitization ? finished.

Said safety means 9 can therefore be part of the spirometer 2, or be part of the spirometry apparatus 8, for example in particular of the processing device 6. Or again, the safety means 9 could be part of the sanitation 5 and configured to detect whether at least the spirometer 2 or also all the components of a spirometric apparatus 8, if provided, have been inserted in the enclosure 50 for sanitization.

How already? mentioned, the system 1 ? preferably portable. Therefore, the sanitization apparatus 5 can? include integrated power supply means configured to supply energy to the whole system and, if the spirometry apparatus 8 ? integrated in the sanitization apparatus 5, also in the spirometer 2.

Alternatively, connectors could be provided for powering the sanitizing apparatus 5 via an external electrical network, for example a domestic one, or at least for recharging the integrated power supply means.

In any case, the portability? of system 1 ? further increased thanks to the control means 54 which can allow the interface with any external device.

The operation of the system 1 to realize a spirometry execution method previously described in structural terms? substantially defined by the new method of performing spirometry as described below.

The new method of performing spirometry according to the invention comprises at least a measurement step, a release step and a constraint step.

Preferably, in the measurement phase, the air movements caused by a user by means of the spirometer 2 are measured. In this phase, at least the first mouthpiece 3 is initially constrained to the spirometer 2.

The user basically inhales and exhales through the first mouthpiece 3.

In the release phase, the first mouthpiece 3 is removed from the spirometer 2. This phase ? preferably made after the measurement in such a way as to remove the part directly in contact with the user?s mouth.

In the constraining phase, on the other hand, the second mouthpiece 4 is constrained to the spirometer 2. In this way, the functionality? of spirometer 2 is restored and a new user can? perform spirometry.

Advantageously, the method also includes a sanitization step.

In the sanitization phase, at least spirometer 2 is sanitized. In particular, it is fully inserted into the sanitizing apparatus 5, in detail into the casing 50, for a predetermined time interval between the release phase and the constraint phase.

Of course, if the casing 50 permits it, the sanitization phase can provide for the sanitization of the entire spirometry system 8.

The predetermined time interval naturally coincides with the time required for sanitization. The sanitization takes place through ozonation of the spirometer 2 or of the spirometric apparatus 8 and, therefore, substantially the predetermined time interval corresponds to a time necessary to occupy a threshold percentage value of the internal volume with the ozone greater than or equal to 80% of the internal volume.

even more in detail, preferably, the predetermined time corresponds to a time necessary for the ozone to occupy a threshold percentage value of the internal volume greater than or equal to 90% of the internal volume.

Furthermore, the method according to the invention provides for repeating the steps of measuring, releasing, sanitizing and constraining in sequence in relation to the number of users to be subjected to spirometry.

In this sense, for example, if there are two users, there will be? one repetition. If there are three users, the process should be repeated a couple of times.

Therefore, other mouthpieces would be expected to be replaced on spirometer 2.

In this sense, the first mouthpiece 3 and the second mouthpiece 4 are to be understood respectively as a mouthpiece ready for use and a mouthpiece to be replaced at the end of use of the mouthpiece ready for use.

The method can, therefore, comprise a blocking phase and an unblocking phase. The blocking step preferably provides for blocking at least the spirometer 2 at the end of the measurement step. Of course, the block can be performed directly on the spirometer 2 or on another functional element of the spirometry apparatus 8 or on the entire spirometry apparatus 8.

The unlocking phase requires that at least the spirometer 2, or all the locked components, are unlocked only if the sanitization phase ? been terminated.

Of course, these phases are managed by the safety means 9 described above. The method can therefore provide, through the cooperation between the sensor means 51 and the safety means 9, that the system 1 verifies that actually at least the spirometer 2, or all the elements to be sanitized of the spirometric apparatus 8, are correctly integrally arranged in the sanitization apparatus , in particular within the casing 50.

In conclusion, the method according to the invention includes, during the sanitization phase, the phases of comparison, determination and notification.

In the comparison phase, the quantity? volumetric ozone ? compared with the internal volume of the casing 50. This comparison ? possible thanks to the control means 52 which receive information from the sensor means 51.

In the determination step, preferably, the achievement of the threshold percentage value by the actual percentage value is determined. These percentage values are respectively predetermined or settable by means of control means 64 and calculated by means of control means 52.

The notification, preferably through the means of notification 53, takes place by notification or by signaling to the user that the threshold percentage value has been reached by the actual percentage value, or by signaling that the sanitization is performed. finished. The invention comprises a novel use of a system 1, as previously described, for spirometry.

The spirometry execution method and system 1 for carrying out said method according to the invention achieve important advantages.

In fact, the spirometry execution method, and related system, are capable of avoiding the continuous disassembly and assembly of the spirometer 2 since only the disposable mouthpieces are subject to manipulation by the operator.

In addition, they allow for a sequential series of spirometry tests to be performed very quickly. and economy.

The spirometry execution method and related system are then really safe since they allow to sterilize all the components of at least the spirometer 2 and, possibly, also of the spirometry apparatus 8, possibly also allowing to sterilize the connection means 7 with the connection cable which could have the starting pin inside the casing 50.

Consequently, the method and relative system according to the invention considerably reduce the possibilities of contamination between successive users.

Furthermore, the method of execution of spirometry, and the relative system, also guarantee a high efficiency of measurement of the movement of air given that filters which at least partially obstruct the passage of air are not necessary, above all in situations in which the flow of air does not flow. air ? weak.

Waste material? extremely reduced given that, substantially, the spirometry execution method, and related system, allow each component to be reused and to use, as a disposable component, only the mouthpieces 3, 4 which, in any case, have reduced costs as they are generally made of cardboard waxed.

In conclusion, system 1 guarantees high portability? which allows you to carry out spirometry in any context and even in the absence of external power sources.

The invention? susceptible of variations falling within the scope of the inventive concept defined by the claims.

In this context, all the details can be replaced by equivalent elements and the materials, shapes and dimensions can be any.

Claims (11)

1. Method of performing spirometry including: - measure air movements caused by a user by means of a spirometer (2) on which ? bound at least one first removable mouthpiece (3), - release, at the end of the measurement, said first nozzle (3), - attach a second removable mouthpiece (4) to said spirometer (2), and characterized by understanding - sanitizing at least said spirometer (2) by arranging it entirely within a sanitizing apparatus (5) for a predetermined time interval between said release phase and said constraint phase in such a way as to sanitize said spirometer (2), - repeating said measurement, release, sanitization and constraint in sequence in relation to the number of users to be subjected to said spirometry. 2. Method according to claim 1, wherein in said arrangement step said sanitizing apparatus (5) sterilizes said spirometer (2) with ozone in such a way as to eliminate any impurities? on said spirometer (2). 3. Method according to any one of the preceding claims, wherein said sanitizing apparatus (5) includes a casing (50) defining an internal volume configured to allow the housing of at least said spirometer (2) and said predetermined time interval corresponds to a time necessary to occupy with said ozone a threshold percentage value of said internal volume greater than or equal to 80% of said internal volume. 4. Method according to any one of the preceding claims, wherein said sanitizing apparatus (5) includes sensor means (51) configured to detect the quantity? volumetric analysis of said ozone within said casing (50), control means (52) configured to compare said quantity? volumetric analysis of said ozone with said internal volume for determining an actual percentage value thereof and for determining when said actual percentage value reaches said threshold percentage value, and notification means (53) configured to notify a user of the achievement of said threshold percentage value by of said effective percentage value, said method further comprising, during said sanitization step, - compare said quantity? volumetric analysis of said ozone with said internal volume, - determining whether said effective percentage value has reached said threshold percentage value, - notifying said user of the achievement of said threshold percentage value by said effective percentage value. 5. Method according to any one of the preceding claims, comprising locking at least said spirometer (2) at the end of said measurement step, verifying that at least said spirometer (2) is integrally disposed within said sanitizing apparatus (5) and unlocking at least said spirometer (2) exclusively if said sanitization phase ? been terminated. 6. System (1) for realizing a spirometry execution method according to any one of the preceding claims, and comprising said spirometer (2), said sanitizing apparatus (5) and at least a first and a second mouthpiece (3 , 4). 7. System (1) according to claim 6, wherein said sterilization apparatus (5) comprises control means (54) operatively connected to said control means (52) and configured to allow said user to vary a volumetric flow rate of introduction of said ozone into said enclosure (50), i.e. a ratio between said quantity? volumetric and a time for introduction of said ozone into said envelope (50) and/or for setting said threshold percentage value. 8. System (1) according to claim 7, wherein said sterilization apparatus (5) comprises an ozonator (55) placed in fluid passage connection with said casing (50) and operatively connected with said control means (54) in in such a way as to allow said control means (54) to determine said volumetric flow rate. 9. System (1) according to any one of claims 6-8, wherein said sterilization apparatus (5) comprises a vent valve (56) placed in fluid flow connection with said casing (50) and configured to evacuate said ozone from said casing (50) when said sanitization phase ? finished. 10. System (1) according to any one of claims 6-9, comprises safety means (9) configured to lock at least said spirometer (2) at the end of a spirometry on a user and configured to unlock said spirometer (2) when called sanitization? finished. 11. System (1) according to any one of claims 6-10, wherein said sanitizing device (5) is integrated within a spirometry apparatus (8) including said spirometer (2), a processing device (6) including electronic elements able to allow the control or command of the operation of said spirometer (2) and connection means (7) suitable for operatively connecting said processing device (6) and said spirometer (2), and wherein said sanitizing device (5) includes said processing device (6) and said connection means (7) and said connection means ( 7) are at least partially contained in said casing (50) and configured to allow said spirometer (2) to be extracted or retracted from said casing (50) for use.