WO2017093360A1

WO2017093360A1 - Device for indicating the operation of an assisted breathing apparatus and apparatus comprising same

Info

Publication number: WO2017093360A1
Application number: PCT/EP2016/079346
Authority: WO
Inventors: Georges Boussignac
Original assignee: Georges Boussignac
Priority date: 2015-12-01
Filing date: 2016-11-30
Publication date: 2017-06-08
Also published as: FR3044229A1

Abstract

The invention relates to a device (20) for indicating the operation of an assisted breathing apparatus (5, 1) intended for a patient (3), the apparatus comprising at least one flow channel (7) for respiratory gases, said indicator device (20) comprising an inner space (27) communicating with the flow channel (7), the volume of the inner space (27) varying depending on the pressure of the gases inside the flow channel (7) relative to the pressure of the environment in which the indicator device (20) is placed. According to the invention, the device (20) comprises a rigid portion (21, 2) for coupling to the breathing apparatus (5, 1) and the flow channel (7) thereof, as well as a sealed flexible wall (22, 31) defining the inner space (27) relative to the environment, the sealed flexible wall being secured in communication with the rigid coupling portion, the rigid coupling portion allowing communication between the flow channel (7) and the inner space (27), and, with equal pressure between the environment and the inner space, at least one portion of the flexible wall has folds (25, 26) and said folds disappear or are reversed when the pressure in the inner space increases relative to the pressure in the environment due to the extension of said flexible wall (22, 31), the volume of the inner space (27), with equal pressure between the environment and the inner space, being less than 50 cm³.

Description

OPERATION INDICATOR DEVICE FOR A RESPIRATORY ASSISTANCE APPARATUS AND APPARATUS HAVING THE SAME

TECHNICAL FIELD TO WHICH THE INVENTION RELATES The present invention relates generally to the field of respiratory assistance equipment. It relates more particularly to an operating indicator device for a breathing apparatus and an apparatus comprising such an indicator device.

BACKGROUND

In the field of resuscitation of patients suffering from cardio-respiratory distress, a promising policy is to democratize the use of resuscitation equipment in order to be able to take care of these people as quickly as possible without waiting for the arrival of the resuscitators or the taking into account. hospital charge. This is particularly the case for defibrillators which now include automatic control means that limit the intervention of rescuers who can be people without specific training. Regarding the respiratory aspect of resuscitation, the equipment used must include means to at least check their correct operation due to possible hazards: leakage in gas circuits, obstruction of the patient's respiratory tract, etc.. It is also preferable that these means are the simplest possible and reliable. Indeed, in the context of the urgency where it is necessary to make "leave" a person, they do not need to be extremely precise with regard to the circulation flows of inspiratory and expiratory gases.

In the field of visualization means for the circulation of respiratory gases in respiratory assistance equipment, documents are known relating to manometers or "floating" ball systems in a gas flow. In particular by the documents US2008 / 004541, US5606131, US5537998, GB2 339 392, WO2006 / 1 10084, US 4,584,997.

Documents US6705320, US4552558, US5360003 and US3731691 also disclose indicating and / or respiratory assistance devices. However, in US6705320 and US4552558 these are "pilot" balloons for controlling the operation of sealing balloons that are described and not means for controlling the breathing of the patient because they are and can not be connected to the duct. Inspiratory and expiratory gas circulation, as leakage of the sealing balloons may cause loss of airtightness. The balloons have an independent circuit. The document US5360003 relates to a balloon indicating the correct positioning or not of an intubation device and whose operation requires that the intubation device be plugged by the balloon. This balloon can not therefore be used to control the breathing of a subject since it prevents it because it is connected to the inlet of the intubation device and that it closes.

These means have various disadvantages depending on the techniques used including the need to provide complex means to operate in all possible directions because the earth's gravitational force can act on the indicator medium and / or the need to implement implement return means, including springs.

OBJECT OF THE INVENTION

In order to overcome the aforementioned drawbacks of the state of the art, the present invention proposes a visualization means based on a modification of a visual appearance of a balloon by varying its appearance following the modification of its internal volume. At rest, that is to say when the pressure in the balloon is identical to the pressure in the environment of the balloon, the wall of the balloon has folds which disappear when the pressure in the balloon increases and, conversely, which increase when it becomes weaker than the pressure in the environment. This pleated / wrinkled appearance of the wall of the balloon is perfectly recognizable and its modifications, or even disappearances, are easily visible. This visibility can be reinforced with colored patterns on the surface or in the mass of the balloon, for example in the folds, which are masked at least partly at rest and become visible during the increase in pressure. It is understood that this concept of folds can extend to any local shape of the wall of the balloon that changes as a function of the internal pressure of the balloon and for example, the flowing appendages of the balloon whose orientation or shape changes depending the pressure difference. In addition, since the balloon may be subjected to internal pressures lower than the pressure of the environment, these appendages may be configured to also unfold internally or invaginate depending on the pressure, the latter reaction to verify that there is a negative internal pressure in relation to the environment.

More particularly, there is provided according to the invention an operating indicator device for a respiratory assistance device for a patient, the apparatus comprising at least one gas flow channel both inspiratory to the patient and expiratory back of the patient, said indicator device having an internal space in communication with the circulation channel, the internal space seeing its volume vary according to the pressure gases in the circulation channel relative to the pressure of the environment in which the indicator device is placed.

According to the invention, the device comprises, on the one hand, a rigid connection part to the breathing apparatus and its circulation channel and, on the other hand, a closed, sealed flexible wall delimiting the internal space with respect to the environment, the sealed flexible wall being fixed in communication on the rigid connection part, the rigid connection part allowing communication between the circulation channel and the internal space, and equal pressures between the environment and the space at least a portion of the flexible wall has folds and said folds disappearing or reversing when the pressure in the internal space increases relative to the pressure in the environment due to the extension of said flexible wall, the volume of the internal space equal pressures between the environment and the internal space being less than 50 cm ³ .

Other nonlimiting and advantageous features of the device according to the invention, taken individually or in any technically possible combination, are as follows:

the device is intended to be used on an apparatus in which the average pressure of the gases over time in the circulation channel is different from the pressure of the environment and it is the average pressure which corresponds to the state of rest of the device with folds of the flexible wall,

the internal space of the indicator device is connected to the circulation channel by a pressure tap of the respiratory assistance device, the rigid connection part being connected to or connected to the pressure tap,

the volume of the internal space at equal pressures between the environment and the internal space is less than 25 cm ³ ,

the volume of the internal space at equal pressures between the environment and the internal space is greater than 10 cm ³ ,

the flexible wall is a balloon having an orifice for access to the internal space, the access orifice being connected and fixed to the rigid connection part,

the balloon is globally spherical,

the balloon is globally hemispherical,

the balloon is generally elongated in the form of a sausage,

the balloon is generally pear-shaped,

- The ball is generally in the form of the upper part of a character, the folds being arms of the character, the arms being along the body equal pressures between the environment and the internal space and the arms apart or rising when the pressure in the internal space increases relative to the pressure in the environment,

- The balloon is generally in the form of a thorax or a front portion of a thorax, the folds being arranged in the form of ribs of a rib cage, the folds at least deviating or approximating according to the pressure difference between the internal space and the environment,

the end of the access port balloon is tightened relative to the remainder of the balloon,

the end of the balloon on the access orifice is widened relative to the rest of the balloon,

the flexible wall is a balloon and the balloon is structured in such a way that at equal pressures between the environment and the internal space, said balloon is self-supporting and at least a part of the wall of the balloon has folds; said folds disappearing or reversing when the pressure in the internal space increases relative to the pressure in the environment by causing the wall of said balloon to extend,

- The self-supporting balloon is maintained only extended regardless of its orientation relative to the vertical equal pressures between the environment and the internal space,

the structuring of the balloon corresponds to different thicknesses of the flexible wall of the balloon,

the structuring of the balloon corresponds to a memory of shape of the flexible wall after molding the balloon in or on a mold of contoured shape,

the flexible wall is a balloon and the flexible wall of the balloon is in itself non-self-supporting and the device internally comprises a stake extending through the internal space between the rigid connection part and at least one zone of support of the inner surface of the balloon, preferably said support zone being opposite to the access port of the balloon, said guard being configured to maintain extended the balloon in a determined direction, said device being further configured so that at equal pressures between the environment and the internal space at least a radial portion of the wall of the balloon which is radial relative to the determined direction has folds, said folds disappearing or reversing when the pressure in the internal space increases relative to the pressure in the environment by causing the extension of said radial portion of the flexible wall,

- the tutor is rigid,

- the tutor is right,

- the tutor is bypassed,

- the guardian is spiraled, the tutor has two opposite ends,

the tutor has branches and therefore more than two ends,

- the tutor is T-shaped or cross,

- the cross is simple or Loraine or more than two transverse bars,

- the guardian is a solid rod,

the guardian is a hollow tube,

the tutor is a hollow tube with at least two ends and in communication with the circulation channel at its end on the rigid connecting part side and said hollow tube comprises a set of lateral orifices staggered along its length allowing communications between the channel of circulation and the internal space exclusively via the inner lumen of said hollow tube,

the guardian is a hollow tube closed at its end on the side of the bearing zone of the inner surface of the balloon,

the height of the guard relative to the rigid connection part is adjustable in order to be able to adjust the tension of the balloon according to the determined direction,

the flexible wall is inextensible,

the flexible wall is inelastic,

the flexible wall is also elastic,

the indicator device is removable from the respiratory assistance device, the rigid connection part of the indicator device can be disconnected from the respiratory assistance device,

the indicator device is integrated in the respiratory assistance device, the rigid part of connection of the indicator device being a part of the respiratory assistance device,

the flexible wall comprises at least one visual pattern whose appearance / appearance varies as a function of the variations of the volume of the internal space.

The invention also relates to a breathing apparatus comprising the operating indicator device of the invention, said apparatus being an open tubular system of inspiratory gas distribution by deflected jets of inspiratory gas injected into a main channel of the tubular system, the main channel having two opposite ends, a distal end intended to be connected to the patient's airways and a proximal end opposite, said tubular system further comprising a sampling circuit communicating with the circulation channel distal side of the deflected jets , the sampling circuit opening out of the tubular system through an outlet nozzle, and the rigid connecting portion of the indicator device comprises means for connection to the outlet nozzle. In said tubular apparatus, the deflected jets of inspiratory gas injected into a main channel of the system provide a valve virtual gas in said main channel and the sampling circuit communicates with the main channel to the distal end of said main channel. The main canal forms part of the traffic channel.

The invention also relates to a respiratory assistance apparatus comprising the operating indicator device of the invention, said apparatus being a face mask comprising a substantially rigid facial shell intended to be applied to a nose and mouth portion of a patient's face. , said mask delimiting between its shell and the face portion the circulation channel and said shell has a mask opening circumscribed through its thickness, said mask opening corresponding to the rigid connection part, the device being integrated into the mask, the flexible wall being fixed on the periphery of the mask opening, the internal space being directly contiguous to the circulation channel.

DETAILED DESCRIPTION OF AN EXEMPLARY EMBODIMENT The following description with reference to the accompanying drawings, given by way of non-limiting examples, will make it clear what the invention consists of and how it can be implemented.

In the accompanying drawings:

- Figure 1 which shows in partial section a breathing apparatus consisting of a face mask and a tubular gas injection system, an indicator device being connected to the tubular gas injection system, the indicator device being in a state of rest corresponding to an equal pressure between the internal space of the indicator device and the environment,

FIG. 2, which represents the assistance apparatus of FIG. 1 but in which the indicator device is in a state corresponding to a pressure in the internal space of the indicator device greater than that of the environment,

FIG. 3 is a partial sectional view of a breathing apparatus consisting of a face mask and a tubular gas injection system, an indicator device being this time installed on the shell of the face mask, a cartridge detailing said indicating device, the latter being in a state corresponding to an equal pressure between the internal space of the indicator device and the environment,

FIGS. 3A and 3B, which represent the cartridge of FIG. 3 in two states, respectively in a state corresponding to a pressure in the internal space of the indicator device lower than that of the environment, and in a state corresponding to a pressure in the internal space of the indicator device greater than that of the environment,

FIGS. 4A, 4B and 4C, which represent views of a cross section of several states of an indicator device balloon,

FIG. 5, which represents a particular example of a removable indicator device for a respiratory assistance apparatus, an internal part of the balloon being represented in dashed lines as viewed in transparency, and

FIGS. 6A, 6B, 6C and 6D, which are simplified schematic cross-sections of a gusset-type folded balloon indicator device.

Device

FIG. 1 shows a face mask on which a tubular gas injection system has been installed, the latter having an indicator device. The mask and the tubular gas injection system are in particular of the type shown in documents FR 2,770,137 or WO2007 / 1,18973 or WO2008 / 1,1313 or their derivatives, based on the respiratory assistance system. Mr. BOUSSIGNAC is an open tubular system with jets deflected gas in a main channel forming a virtual gas valve.

The facial mask 1 placed on a patient's face 3 comprises a substantially rigid shell 2 generally frustoconical 2, applied to the face 3 of the patient via an inflatable pad 4, bordering its peripheral opening. On the opposite side of the pad 4, said mask 1 comprises a connecting tube 6 on / in which is fixed or fitted the open breathing assistance system 5 with deflected jets and virtual gas valve. The respiratory assistance system 5 serves as a mouthpiece for entering and leaving breathing gas in the mask 1. In variants, another type of respiratory assistance system may be connected to the mask.

The respiratory assistance system 5 comprises a main channel 7 passing internally and, in the middle part, a conical wall 8 projecting inside said main channel 7. This respiratory assistance system 5 is an open tubular distribution system. inspiratory gas by deflected jets of inspiratory gas injected into the main canal of the system. This type of device is described in particular in the patent application FR2645026 and has been the basis of many improvements. The main channel 7 serves as an inspiratory gas flow channel for the patient and expiratory coming back from the patient. The purpose of the conical wall 8 is to deflect, in the direction of the axis of the main channel 7, jets of respiratory gas injected by auxiliary / peripheral channels 9, supplied from a delivery nozzle 10, by the intermediate of an annular chamber in the thickness of the wall of the tubular respiratory assistance system. The main channel 7 is open in the environment at its proximal end 16. Moreover, on the distal side 1 1 of the respiratory assistance system 5, a coaxial annular peripheral chamber 12 communicates with the interior of the mask 1 by a distal annular orifice and is provided at its proximal end with an outlet tip 14, the assembly forming a sampling circuit. A filter 15, fibrous or porous (cotton, synthetic foam, etc.) may be disposed in the annular peripheral chamber 12, to damp the gaseous turbulence and, consequently, the excessive pressure variations. It is therefore possible to measure the pressure prevailing in the face mask through the outlet nozzle 14. Such a distal annular chamber is described in particular in the document FR19970013430.

An operating indicator device 20 has been connected to the output nozzle 14. The indicator device has an internal space / volume 27 in indirect communication with the circulation channel via the annular peripheral chamber 12 and this internal space sees its volume varies according to the pressure of the gases in the main channel relative to the pressure of the environment in which the indicator device 20 is placed.

In general, the variable volume internal space 27 of the indicating device 20 is in communication with the patient, distal, portion of the respiratory gas flow channel relative to the deflected jets in order to effectively measure the gas flows relative to the patient. The pressure taken in the circulation channel for the measurements and which communicates with the internal space, besides being 12 at the distal end 11 of the respiratory assistance system 5 in the figure, can therefore be found in any other position distal side of the jets, that is to say patient side. In addition, it may be on any other type of open-air breathing apparatus open deflected virtual valve and for example an intubation tube.

The indicator device comprises, on the one hand, a rigid connection part 21 to the outlet endpiece 14 of the breathing apparatus 5 and, on the other hand, a sealed flexible flexible wall of a balloon 22 defining the space internal 27 with respect to the environment. The balloon 22 is fixed in communication on the rigid connection part 21. The dimensions and structure of the balloon 22 cause the volume of the internal space equal to the pressures between the environment and the internal space to be less than 50 cm ³ and is typically about 15 to 20 cm ³ .

The balloon is structured to have radial folds with elevated areas 26 or ridges and recessed areas or bottoms at a state of rest, i.e. equal pressures between the environment and the body. internal space 27 as shown in FIG. Note that this state of rest can in variants correspond to a defined difference in pressure between the internal space and the environment and for example a difference between an average temporal pressure of the circulation channel and the environment, the pressure of the environment being considered substantially stable over time.

This structuring with folds at rest can be the result of localized thickening of the wall and / or molding with shape memory of the material of the balloon. The material of the balloon is essentially flexible and it can, in addition, be elastic. In the case of the balloon of FIG. 1, these folds are essentially radial with respect to the main extension axis of the balloon. These folds also result from the fact that the flexible wall, possibly elastic, in particular the balloon, is stretched by a stake whose bearing area on said flexible wall is of relatively small surface relative to the radial / transverse extent of said wall /ball.

When the pressure in the internal space of the indicator device becomes greater than that of the environment, the folds fade and disappear and finally an external surface of the substantially smooth balloon is obtained, as shown in FIG. the intermediate aspects will be possible between an inversion or absence of folds and the presence of folds of the state of rest as a function of the pressure difference between the internal space and the environment. It is also understood that in the case where the pressure in the internal space of the indicator device becomes lower than that in the environment, the folds will increase more and more depending on the pressure difference.

In a variant in which the wall of the balloon is structured with areas of increased thickness of material having less flexibility than other areas, instead of having a smooth appearance when the pressure in the internal space of the indicator device becomes higher than that of the environment, the folds can be reversed with respect to the state of meal: the hollows of rest become bumps with the pressure difference. Different inversion thresholds can be provided by folding, ie the inversion will occur only for a given level of pressure difference for a given fold.

The modulation of the appearance of the folds of the balloon thus gives an idea of the pressure difference between the patient's respiratory gas circulation channel and the environment. It is thus possible to detect a leak of the mask giving small variations of appearance around the state of rest, an obstruction of the airways of the patient giving small variations in appearance but around an inflated state without folds or reduced folds ...

The balloon implemented can be self-supporting, that is to say it is extended / extended regardless of its orientation at rest (and in the absence of external constraint) including through the implementation of a structured balloon with thickened wall areas less flexible than other areas.

However, the case of non-self-supporting balloons is provided by implementing a guardian internal to the balloon and which extends into the internal space of the indicator device. In FIGS. 1 and 2, this guard is a hollow tube 23 having stepped lateral orifices 24. The tube 23 is fixed on the rigid connection part 21 and is arranged in communication with the outlet nozzle 14. It can be provided a height adjustment of the tube 23 relative to the rigid connection portion 21 to tend more or less the balloon 22.

In FIG. 3, an alternative embodiment is shown: the sealed flexible wall 31 is this time fixed on the shell 2 of the mask 1. The mask has a mask opening 30 circumscribed through its thickness and the flexible wall 31 is sealingly attached to the periphery of the opening 30. In this embodiment, the internal space of the indicator device is in direct continuity with the interior space of the mask 1, interior space of the mask which corresponds to the respiratory gas circulation channel. The interior space of the indicator device corresponds here to the volume defined between the opening 30 and the flexible wall 31. The rigid connection part is integrated in the shell of the mask and corresponds to the periphery of the mask opening 30.

At rest, that is to say equal pressures between the environment and the internal / internal space, the flexible wall 31 has folds as shown enlarged in the cartridge of Figure 3. Now, if the pressure inside the shell of the facial mask decreases with respect to the pressure of the environment, the flexible membrane will deform and the folds will fade or disappear depending on the pressure difference as shown in Figure 3A. Conversely, if the pressure inside the shell of the face mask increases relative to the pressure of the environment, the flexible membrane will deform and the folds will fade or disappear depending on the pressure difference as represented in FIG. 3B. As indicated above, it is possible to obtain other deformation effects with a particular structuring of the flexible wall and, for example, inversion or increase of the folds. It is understood that these changes of the folds are reversible depending on the direction of the pressure difference.

In order to make these changes in appearance of the flexible wall or the balloon even more visible, individualized visual patterns are printed or in the mass of the folds. The relative disposition of these individual visual patterns between them will therefore change depending on the deformation of the flexible wall. For example, in the case of a pleated flexible wall, colored or black patterns are provided at the bottom of the folds, these patterns being substantially masked at rest in the wall because the ridges that separate them can get closer to each other, and in the case where the internal pressure increases, the grounds will be evangelized (prolapsed) and become visible.

In FIG. 4A, the indicator device 20 comprises a flexible wall which is a balloon 22 with radial folds is in the rest state, that is to say that the pressures in the internal space 27 and the environment are equal. In this state of rest, the hollow zones 25 are towards the interior of the balloon with respect to the ridges 26, the peaks being here widened at their top relative to their base, which partially obscures the bottom of the recessed areas which can have a contrasting visual pattern. In FIG. 4B, the pressure in the internal space 27 is greater than that of the environment and the inversion of the folds has been inverted: the previous recessed areas have evaginated and the visual pattern becomes perfectly visible. In FIG. 4C, the pressure in the internal space 27 of the balloon 22 has further increased and all the folds have been erased.

In general, the indicator device of the type of FIGS. 1 and 2 may be used on any respiratory assistance device having a connection for measuring the pressure of the respiratory gases on the patient's side and in particular on devices used in resuscitation. cardiopulmonary with continuous oxygen injection and continuous cardiac massage, cardiac massage to provide sufficient basic ventilation in emergency conditions. In particular, the apparatus with deflected jets, restriction of passage of gases and lateral safety orifice of the company VYGON is particularly useful in such a context. The means implemented in the latter device are described in particular in the documents: FR1998001 1027, FR2971 162, FR20060003036.

The indicator device 20 of FIG. 5 is of the self-supporting flexible wall type, but in an alternative embodiment this flexible wall may be non-self-supporting and the device internally comprises a guard. The device of FIG. 5 comprises a rigid connection part 21, a tubular connection part 28. As seen by transparency in FIG. 5, the wall of the balloon 22 has a double fold 29 with a shape memory that can be erased more or less depending on the pressure inside said balloon 22 with respect to the pressure on the outside: in the event of an increase in the internal pressure, the height of the balloon will increase by evagination of its upper part of the balloon and conversely in the event of a drop in pressure, invaginate, the height of the balloon decreasing. In the case of the implementation of an internal tutor, the tubular connecting portion 28 may constitute a part of the tutor, the tubular connecting portion continuing in the balloon 22 by opening. The internal guardian can form a stop for intussusception of the upper part of the balloon in the double-folded example of FIG.

In another embodiment, the folds are external and the balloon has a form of accordion bellows or bandoneon with a preferably circular cross section. As before the folded appearance of the ball due to the folds will fade or increase depending on the internal pressure of the balloon, which will also change the dimensions of the ball. This is the case of the indicator device 20 of FIGS. 6A to 6D, the balloon 22 of which this time has folds that are no longer axial but transverse with elevated zones 36 or ridges and recessed areas 55 or bottoms of the bellows constituted by the balloon 22. A visible mark 34 is carried by the balloon, the free end of the balloon in this example. The visible mark 34 will move according to the swelling or deflation of the balloon 22. Fixed indications 33 are arranged in relation to the possible positions of the visible mark 34. The indications 33 are here graduations inscribed on the wall of a hollow tube 32 of the indicator device and which is open to the air, surrounds the balloon 22 and which allows to see the visible mark 34 through its wall. In Figure 6A, there is equal pressure in and outside the balloon and the visible mark is at the height of an indication "0". In FIG. 6B, the pressure in the balloon is greater and the balloon has expanded, the visible mark being found at the level of an indication of relative pressure "+15" which is arbitrary here but which could, in certain modalities, correspond to concrete physical units, for example cm of water. On the contrary, FIG. 6C, the pressure in the balloon is lower and the balloon has retracted, the visible mark being found at an "-10" indication. The shape memory of the material constituting the balloon returns the visible mark to "0" when the pressures equalize in the balloon and outside thereof. The wall of the balloon is flexible and possibly it can be more or less elastic.

In the indicator device of FIG. 6D, a spring 37 is fixed between the free end of the balloon 22, the one which moves in height and which carries the visible mark 34, and a fixed point of the open end 32 'of the tube hollow 32. It is recalled that this hollow tube 32 is open to the open air so that the balloon is subjected externally to the pressure of the free air. Communication ports can be made along the wall of the hollow tube 32. The spring can work in compression or extension according to the embodiment and it improves the quality of measurements. Tare means (not shown) for prestressing more or less the spring can be implemented.

The inside of the balloon 22 can therefore be placed in communication with the gas circulation channel which is both inspiratory and expiratory of a respiratory assistance device by removable connection of the rigid connection part 21 on a pressure tap of said apparatus. The term pressure take-off must be understood as being generic and functional in that it is a means of communication with the gas circulation channel of the apparatus. The balloon 22 of FIG. 5 has a reduced internal volume of less than 10 cm ³ and preferably of about 3 cm ³ at rest (in the absence of a pressure differential) and it will form a dead arm in the channel bypass. gas circulation which has a negligible impact on this circulation. The device of Figure 5 results from the assembly of two elements made separately by molding plastics: a member forming the balloon and the tubular connecting portion and a member forming the rigid connecting portion.

The indicator device of the invention is therefore a passive indicator connected in shunt on the gas circulation channel and which does not disturb this circulation because constituting a "dead arm" / "a cul de sac". In the case where the indicator device consists of a flexible wall, possibly elastic, on a circumscribed opening of a face mask, this indicator forms a "magic eye" indicative of the gas flow and therefore the ventilation of the patient. This indicator device is particularly simple, effective and intuitive by giving a general indication of the ventilation of the patient and it can be used alone or associated with a manometer / pressure sensor if one wishes precise measurements or monitoring ("monitoring"). In the latter case, it is possible to use a Y-connection, possibly with a selection valve, which is connected to the circulation channel, a Y-connection, one of the branches of which goes to the indicator balloon and the other branch goes to a manometer or a pressure sensor. The device is particularly indicated in conditions of emergency resuscitation, in the field, people practicing resuscitation are not necessarily professionals and do not need specific indications at first.

Claims

1. Indicating device (20) for operating a respiratory assistance device (5, 1) intended for a patient (3), the device comprising at least one circulation channel (7) of both inspiratory gas intended for the patient and exhalation coming back from the patient, said indicator device (20) having an internal space (27) in communication with the circulation channel (7), the internal space (27) having its volume varying according to the pressure of the gases in the circulation channel (7) relative to the pressure of the environment in which the indicator device (20) is placed,

characterized in that the device (20) comprises, on the one hand, a rigid connection part (21, 2) to the respiratory apparatus (5, 1) and its circulation channel (7) and on the other hand , a sealed flexible wall (22, 31) closed defining the internal space (27) relative to the environment, the sealed flexible wall being fixed in communication on the rigid connection part, the rigid connection part allowing communication between the circulation channel (7) and the internal space (27), and in that at equal pressures between the environment and the internal space at least a portion of the flexible wall has folds (25, 26) and said folds disappearing or reversing when the pressure in the internal space increases relative to the pressure in the environment due to the extension of said flexible wall (22, 31), the volume of the internal space (27 ) equal pressures between the environment and the internal space being less than 50 cm ³ and in that the internal space (27) of the indicator device is connected to the circulation channel (7) by a pressure tap (14) of the respiratory assistance device, the rigid connection part being connected or connected to the pressure tap (14).

2. Device according to claim 1, characterized in that the flexible wall is a balloon (22) and the balloon is structured so that at equal pressures between the environment and the internal space said balloon is self-supporting and at least a portion of the wall of the balloon has folds (25, 26), said folds disappearing or reversing when the pressure in the internal space (27) increases relative to the pressure in the environment causing extending the wall of said balloon (22).

3. Device according to claim 1, characterized in that the flexible wall is a balloon (22) and the flexible wall of the balloon is itself non-self-supporting and in that the device (20) internally comprises a guardian (23). ) extending to through the internal space (27) between the rigid connecting portion (21) and at least one bearing zone of the inner surface of the balloon (22), preferably said bearing zone being opposite to the access port of the balloon, said guard (23) being configured to maintain extended the balloon in a determined direction, said device being further configured so that at equal pressures between the environment and the internal space at least a portion radial of the wall of the balloon which is radial with respect to the determined direction has folds (25, 26), said folds disappearing or reversing when the pressure in the internal space (27) increases with respect to the pressure in the environment by causing the extension of said radial portion of the flexible wall (22).

4. Device according to claim 3, characterized in that the tutor is a hollow tube (23) at least two ends and in communication with the circulation channel at its end side rigid connection part and in that said hollow tube comprises a set of lateral openings (24) staggered along its length allowing communications between the circulation channel and the internal space exclusively via the inner lumen of said hollow tube.

5. Device according to claim 4, characterized in that the tutor is a hollow tube (23) closed at its end side of the support zone of the inner surface of the balloon (22).

6. Device according to claim 4 or 5, characterized in that the height of the guard (23) relative to the rigid connecting portion (21) is adjustable in order to adjust the voltage of the balloon (22) in the determined direction.

7. Device according to any one of the preceding claims, characterized in that the flexible wall (22, 31) is further elastic.

8. Device according to any one of the preceding claims, characterized in that the flexible wall (22, 31) comprises at least one visual pattern whose appearance / appearance varies as a function of the variations of the volume of the internal space (27). ).

9. Respiratory assistance device (5) with an operating indicator device (20) according to one of the preceding claims, said device being an open tubular system (5) of inspiratory gas distribution by deflected jets of inspiratory gas injected into a main channel (7) of the system tubular, the main channel (7) having two opposite ends, a distal end (1 1) intended to be connected to the patient's airways (3) and a proximal end (16) opposite, said tubular system (5) further comprising a sampling circuit (12, 14) communicating with the circulation channel on the distal side of the deflected jets, the sampling circuit emerging from the tubular system by an outlet end (14), and in that the rigid connection part (21) of the indicator device comprises means for connection to the outlet tip.

10. Respiratory assistance device (1) with an indicator device (31) according to one of claims 1 and 2, possibly combined with claim 7, said apparatus being a face mask (1) having a shell (2) substantially rigid facial mask intended to be applied to a nose and mouth portion of a patient's face (3), said mask (1) delimiting between its hull (2) and the face portion the circulation channel and in that said hull (2) has a mask aperture (30) circumscribed through its thickness, said mask aperture (30) corresponding to the rigid connecting portion, the indicator device being integral with the mask, the flexible wall (31) being fixed on the around the mask opening (30), the internal space being directly contiguous with the circulation channel.