WO2019123366A1

WO2019123366A1 - A device for mechanical limitation of insufflation for a manual ventilation device

Info

Publication number: WO2019123366A1
Application number: PCT/IB2018/060424
Authority: WO
Inventors: Andrea PAGANI; Stefano SIMEONE
Original assignee: Pagani Andrea
Priority date: 2017-12-22
Filing date: 2018-12-20
Publication date: 2019-06-27

Abstract

The present invention has as its reference field the health field with particular reference to clinical devices. In particular, this invention is aimed at a large number of potential recipients in the health field, the invention in question is designed to monitor and limit the volume insufflated during pulmonary ventilation performed with a limited self-expanding resuscitation balloon of a patient who needs manual respiratory support. This invention therefore describes a safety device. The invention is therefore part of the health care framework of a patient who is not able to provide spontaneously breathing.

Description

A DEVICE FOR MECHANICAL LIMITATION OF INSUFFLATION FOR

|A MANUAL VENTILATION DEVICE

Text of the description

FIELD OF THE INVENTION

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

In particular, this invention is aimed at a large number of potential recipients in the health field, the invention in object is designed to monitor and limit the volume insufflated during pulmonary ventilation performed expecially with a resuscitation balloon or for manual ventilation, for example self-expanding for a patient who needs manual respiratory support.

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

The pulmonary ventilation of the patient who does not have an independent breathing capacity is usually supported mechanically by a pulmonary ventilator or manually by an operator, usually providing health care, who, by compressing a special self-expanding resuscitation balloon or a balloon filled with a flow of oxygen/gas (so-called anesthesia balloon), replaces the respiratory work of the person.

In the present application only pulmonary ventilation by means of a manual ventilation balloon is considered, such as a self-expanding balloon, as the innovative device will adapt to it advantageously to solve known prior art problems not completely solved, as explained below.

KNOWN PRIOR ART

As is well known in the field, a manual ventilation balloon, such as a self expanding balloon, must be put in contact with the patient's respiratory system by means of a special mask that adheres to the patient's face or by means of a tube (generally endotracheal, but also laryngeal or a laryngeal mask or other special devices) that isolates the airways.

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

It is precisely on the protection from this excess that the device described below in this patent application is concentrated, shifting the aforementioned finesse and safety of mechanical ventilation to the coarser manual ventilation which, at the state of the art, in this sense, has disadvantageously the benefit only of the manual skill/experience of the operator and of the existence of balloons of different sizes to be used depending on the age/weight of the patient.

It should be noted that this problem has already been addressed by the applicant himself in the description of a further innovative device referred to in patent application no. 102017000117302 of 17/10/2017 examined in the following, in which case the solution to the technical problem has been approached in a completely different way with respect to what will be described below in this invention.

Therefore, with regard to the problem of limiting the excess of insufflation volume due to manual ventilation, it will be possible to use both the proposed devices in combination or alternatively one with respect to the other, as described below.

Concerning the technical problem, it is observed introductive that pulmonary capacity (the volume of air that can be contained in the lungs) varies from person to person and generally the pulmonary capacity is estimated according to age groups, sex, weight/height and respiratory diseases. The most important distinction is obviously the one that differentiates between adults and children.

In order to reduce the risk that a quantity of air/oxygen/gas greater than the patient's pulmonary capacity is insufflated (with regard to the invention, this is the most critical technical problem), according to the state of the art, self- expandable resuscitation balloons of different sizes are proposed, which the operator can choose according to the type of patient; to avoid this problem, these balloons are sized according to the patient's age/weight. Commonly commercially available balloons are of about 21 or less (for the adult patient) and balloons of about II or less (for the pediatric patient). There are also other balloons having different volume and some having very low litrage, dedicated to the newborn.

Note that, disadvantageously, the amount of air/oxygen/gas that is indicated to insufflate, in addition to what has just been specified, may also vary depending on any respiratory diseases of which the patient is affected, this factor is equally important and the correct choice in this case may depend only on the operator, this causing obvious dangers for the patient given the uncertainty of the cases.

As is well known, the insufflation of an air/oxygen/gas volume greater than a person's pulmonary capacity has obvious and potentially serious traumatic consequences on the patient's respiratory system, such as volutrauma.

In an extremely disadvantageous way, at the state of the art, in addition to the choice of the balloon having volume appropriate to the patient and the experience of the operator who carries out the ventilation, nothing protects the patient from an excess of insufflated volume; from this the applicant has considered it useful and necessary to propose two different solutions to this important technical problem, of which, as mentioned, one is described in the patent application no. 102017000117302 of 17/10/2017, to which reference should be made. Said patent application proposes a device with a flowmeter function for regulating manual pulmonary ventilation, suitable for connection to a common manual ventilation balloon by limiting in a controlled way the volume and/or pressure of the air/oxygen insufflated gas, this by means of a microprocessor included in the device, this device acts in practice as an "automatic" safety device. The device allows advantageously to be used on any device for manual ventilation, so eliminating the need for different types of balloons available, being able to be set and adjusted before use. This device therefore brilliantly solves the technical problem by reducing the need for various equipment (no longer needing different types of balloons of different liters), and can also be helpful in situations where the patient has to be moved as well as being able to guide even the most inexperienced operator.

Unlike the device described so far, the one that will be described in this invention differs from the previous one for the exclusively physical/mechanical nature of the limitation device that will be proposed: in this case it will be proposed to limit the volume of insufflation only.

It therefore addresses part of the same technical problem, but distinguishing itself evidently from the solution proposed for the nature of the extremely simple construction of the device, which is not regulated electronically, and for the ease of use of the same.

In order to underline the importance of the problem, it is highlighted the known art document W02009/032932 which describes in particular a manual resuscitation device including: a manually compressible resuscitation bag comprising a closed inner chamber having a gas inlet/outlet opening at one of its proximal ends, in which said resuscitation bag is compressible to discharge an air volume in response to compression at one of the distal ends of said bag; a mobile volume adjustment group axially positioned in said inner chamber comprising a follower group including a bag compression stop element and a tracker device rigidly attached to it and extending proximally from it; a mobile volume control element rotatably fixed at or adjacent to the proximal end of said resuscitation bag and a traction unit cooperating with it and configured to contract and force the movement of said assembly in response to the rotation of said volume control element; a gas inlet/outlet tube communicating with said internal chamber through said gas inlet/outlet opening and configured to direct a volume of air from said resuscitation bag in response to its compression.

Note in particular that this device is to all intents and purposes a new device for manual ventilation for which it has the main purpose of going to replace the balloons diffused worldwide in every hospital, ambulance, etc.: so the device described here is not intended to solve the problems of the known ventilation balloon device, such as a self-expanding balloon and can not still be integrated with a normal device of ventilation known. This aspect is a significant disadvantage for the device described in the document mentioned above, to take advantage of the advantages of the device you would need to go and replace all the balloons on the market with this device, something economically virtually impossible to propose given the health practices, and also given the ease of use, affordability and small encumbrance of the famous balloon for manual ventilation used by all.

Apart from the advantageous possibility of limiting the volume, this device does not seem to have other advantages that the common resuscitation balloon possesses. Furthermore, it is used only for manual ventilation, i.e. it intends to replace the self-expanding balloon, but it does not propose solutions suitable for other types of balloons existing in the sector, such as a balloon filled with oxygen/gas flow (so-called anesthesia balloon) or similar.

It should be noted that in particular this device will be very different from that proposed by the present invention for various reasons listed below.

Also note that this known art device differs in its main purpose from the present invention, as will be described below.

It is particularly felt the need to overcome the limits of the known art until now exceeded only by the skills, competence and experience of the operator who performs manual ventilation, or solved by devices of different kinds/sizes that have the said further disadvantages.

One purpose of this invention is therefore to provide a simple physical insufflation volume limitation device suitable for manual ventilation devices such as resuscitation balloons.

A further purpose of this invention is therefore to provide an aid to the operator, even inexperienced, who must perform 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.

Another purpose of this invention is to make available a purely mechanical device.

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 plurality of manual ventilation devices.

Note that in particular it is a purpose of this invention to describe a device suitable for integration with known manual ventilation balloons and/or similar devices, such as self-expanding balloons and so-called anesthesia balloons. A parenthesis is hereby opened: in detail, the patent application no. 102017000117302 above, describes an electronic device that is placed and connects downstream of the resuscitation balloon limiting the insufflation both for volume and pressure acting downstream of the pressing of the same balloon by detecting the parameter (volume/pressure) and limiting the same by means of appropriate valve(s) set by the user.

The device object of the present application, on the other hand, aims to limit only the volume of insufflation by means of a body that creates a physical occupation of the space inside the balloon, for example self-expanding, being already known that, if/as desired and set by the user, limits the complete squeezing of the same (given by the complete emptying of its content), while still ensuring the possibility of choosing the volume limit of air / oxygen/gas insufflated by physical means instead of electronic means. BRIEF SUMMARY OF THE INVENTION

These and other advantages will be obtained by virtue of the innovative device that is the object of this invention in which this device is essentially a device for mechanical limitation of insufflation for a manual ventilation balloon that can be integrated with the ventilation device, such as a self expanding balloon or, for example, a so-called anesthesia balloon, said device comprising at least a reducer of the volume inside the balloon and at least one regulator for said reducer of the volume that will be controllable preferably manually by the user.

The device being characterized by the fact of comprising at least one reducer of the volume inside the balloon and at least one regulator for said reducer, said regulator can be controlled manually by a user, said reducer being positioned inside the manual ventilation balloon, said reducer increasing or decreasing its volume depending on the setting of the regulator, said reducer being, in particular in one of the forms illustrated, substantially incompressible so that at the compression of the ventilation balloon limiting the compression of the balloon opposing mechanical strength.

Said device, by virtue of also to its small size and its thin shape (when in "minimum volume occupancy" mode), is advantageously placed, if it is not already included in its production, inside the ventilation balloon device, for example simply by inserting it from one end, the one to which is normally connected to the ventilation mask for example, until it reaches the opposite one and anchoring it for example by means of a screw, snap or pressure fitting and, with the same fitting for example, anchoring it then also at the end of the balloon from which it was entered by occluding its ends and preventing the passage of air except in the path dedicated to it by virtue of the fact that its length should preferably be compatible with the length of the balloon of which it is likely to constitute the central axis.

The connections between the device and the auto-expandable balloon are characterized by a potentially hermetic connection between the extremities of the body of the invention and the pre-existing balloon or by two elements that join, for example, by snapping or screwing to block the circumference of the openings on the extremities of the balloon. These fittings fit into the round openings of the flexible and compressible part of the balloon bilaterally and are therefore preferably round and of the same size so that they can be joined together to prevent possible air leakage from unwanted passages. These fittings are to be considered optional because the device could be either connected to an existing balloon or, better, be advantageously integrated into a balloon that already includes it at the start.

This device is able to limit mechanically, depending on the will, or the adjustment made by the user, the "squeezing" of the auto-expandable balloon, the reducer therefore opposes mechanical resistance to squeezing. This limitation device advantageously prevents the hand of the user who is ventilating the patient by physically squeezing the manual balloon from completely emptying the air/oxygen/gas contained in it, thus placing a mechanical limit on the complete closure of the hand that holds the balloon, thus offering mechanical resistance to squeezing by virtue of the manufacturing nature of the reducer.

The mechanical limit is given by the body of the reducer itself, or rather by the volume it occupies in the balloon, this volume is variable and adjustable by the user, the regulation is done by virtue of a volume regulator for said reducer, the reducer will occupy more or less volume inside the manual ventilation balloon for example self-expanding.

In a preferred embodiment, this reducer is a "cage" reducer, i.e. it includes flexible slats attached to their ends, for example to a central axis; these slats, being able to widen preferably from the central axis of the balloon by means of a regulator controlled by the user, produce an increase in the occupancy of the internal volumetric space of the balloon. The reducer in "minimum volume occupancy" mode (Vr=0 is defined as the condition of minimum volume occupancy of the reducer) will have a fusiform structure with main direction of development along a central axis that will correspond, once placed in place, to that of the balloon, in this position the reducer does not occupy substantially useful volume in the balloon.

Such flexible slats may be hinged at both ends in rings, e.g. bound at least fluently along that centre line, at least one of those rings shall be free to rotate about the centre line, at least one of those rings shall be free to rotate about the centre line, or be free to move freely along the line; the number of slats may be any number, preferably at least two or more. In a variant both slats can be fixed at both ends to each other and remain free flowingly on the axis: in case of screwing (Vr>0) by virtue of appropriate strikers fixed on the screw and screw nut the ends will be pushed towards each other, in case of "unscrewing" (Vr tending to 0) the slats will return to the linear position as a result of the elastic return in case of elastic slats, by other ways in other forms of construction.

The central axis can be made up of a screw and a nut. The screw will be connected, for example, to a ring nut that regulates the rotation of the screw, the ring nut being called the regulator. At least one ring will preferably be attached to the screw or nut.

By rotating the ring nut in one direction or the other, the operator will act on the screw that will promote an approach of the two ends of the flexible slats that will bend increasing the occupancy of the internal volume of the balloon, vice versa, rotating the ring nut in the other direction, the screw will promote a shifting of the two ends of the flexible slats, decreasing the occupancy of the internal volume of the balloon. In a different embodiment, these slats can be fixed in any way suitable to obtain the desired effect.

The quantification of the volumes is possibly carried out by means of a graduated scale on the ring nut that explicitly correlates "screw turns" - "volume occupied" and therefore puts the user in a position to exercise a precise choice.

The extent of the screw rotation and the consequent increase of volume of the cage that takes shape from the central body of the device is decided and operated by the user who potentially adjusts to a visual scale preferably with chromatic and volume references (expressed, for example in ml or cm³) or type/category of the patient potentially placed visibly on the body of the device or on the end of the screw itself (the position and presentation of the visual scale are not intended in a restrictive way of the conceptual content of the invention but are intended as an explanation and facilitation of use). Basically, the maximum final volume of physically allowed insufflation will be given by the total volume of the auto-expandable balloon (Vp) from which the volume of the reducer (Vr) will be subtracted, established and calibrated, for example, at the time of manufacture, leading to insufflated volume = (Vp - Vr).

The reducer in position (Vr=0) has a fusiform structure and does not occupy volume in the balloon, at (Vr>0) the reducer occupies volume (Vr) in the balloon, the balloon can deliver a volume of air equal to (Vp-Vr), the volume of air that can be delivered by the balloon being reduced in proportion to the increase of (Vr)

In the case of cage reducer, at (Vr=0) said slats being parallel to the central axis, increasing of (Vr) the extremities of said slats approach each other and said slats bend in the balloon occupying a volume (Vr).

The principle used, in order to be made more understandable, can be comparable to and recall the functioning of a coronary stent (merely cited herein as an explanation).

In another embodiment, the reducer includes an air chamber that can be inflated by the user and which is likely to be located at the central axis of the ventilation balloon, also in this case, if it is not already included in its manufacture, by removing the fitting at one end of the balloon, the reducer can be physically inserted into the body of the balloon itself until it reaches the opposite end and anchors it, for example, by means of a screw, snap or pressure fitting and, with the same fitting, anchors it then also at the end of the balloon from which it was entered, occluding the said ends and preventing the passage of air except in the path dedicated to it. Said reducer is always connected to a volume regulator which in this embodiment is represented, for example, by a syringe (or other suitable means for the same purpose) suitably capable, removable from the device and intended to inflate the said air chamber with its air content quantitatively chosen and then manually adjusted by the operator who will have as a consequence a corresponding subtraction of the volume inside the balloon due to the filling of the air chamber of the amount of air injected with the said syringe. As can be seen from this, in this case, in order to increase the volume of the reducer, the desired volume of air will be injected (so-called cap with syringe) so that, for example, by injecting 100 ml of air with the syringe (also by means of multiple injections) into the air chamber that characterizes the reducer in this embodiment, this reducer will subtract 100 ml of the volume that can be insufflated into the lungs of the patient. To reduce the volume occupancy of the reducer, however, it will be sufficient to simply suck in the excess amount of air in the reducer with the said syringe. The variation of the chamber volume causes the variation of the occupancy of the volumetric space inside the balloon.

In this preferred embodiment (for convenience referred to here as "air chamber"), the device includes at least one substantially expandable fusiform body made for example (but not necessarily) of plastic material that will be placed in the center of the balloon auto-expandable, preferably on the central axis of the same, connected internally at its ends with the same auto- expandable balloon.

The reducer here is an air chamber also equipped with access to it from the outside through a special inflation duct and its connection for a syringe (or other means acting for the same purpose). This fitting should preferably consist of a standard syringe fitting with, for example, an attached unidirectional valve to prevent the backflow of the injected fluid (air). A non- exhaustive example of such a connection could be the well-known "luer-lock" (of which nothing is claimed in the present application) widely used in the health field as a typical connection for connecting syringes to different types of circuits, in particular, with regard to the present invention, to capped circuits.

By means of this syringe it is possible to modify the internal occupancy of the volume of the balloon by means of the inflation criteria preferably with air from this air chamber which, inflated, subtracts internal volume to the balloon.

Inflating can be carried out, for example, with the use of a graduated syringe of adequate volume to inject the desired amount of air (Vr) into the air chamber included in the device, preferably placed along the central axis of the auto-expandable balloon, which, subtracted from the total capacity of the balloon (Vp), will determine the physical limit of volume beyond which it will not be possible to continue the insufflation. Therefore insufflated volume = Vp- Vr.

The choice of the size of the capping (note: filling) of the air chamber included in the device will be precise and according to criteria determined by virtue of a special visual scale (preferably colored and representing the details of the choice to be made) probably reported for example also on the syringe itself. The syringe (preferably of adequate capacity) may preferably carry a graphic representation of the volume expressed in ml/cm³ of air contained in it or, as an example, a graphic reference to the type of patient to be ventilated (e.g. distinct per kg of weight or age group).

The device limits the volume of air/oxygen/gas that can be insufflated in through the occupation of space inside the auto expanding balloon by an additional balloon that the user inflates in a controlled way inside the auto balloon. The maximum final volume of the physically allowed insufflation will be given, with the same logic of the previously described embodiment, by the total volume of the balloon (Vp) from which the volume of the air chamber (Vr) will be subtracted. This volume is established and calibrated, for example, during manufacture according to the parameters of respiratory physiology (for example, ensuring that the insufflated volumes correspond to those indicated in relation to the pulmonary capacity of the patient to be ventilated and are correctly represented on the visual scale of reference).

The invention in a particularly advantageous way therefore describes a device that limits the volume of insufflation according to the operator's settings in a safe and pre-defined way, so in a completely advantageous way the device is a safety device.

This device is particularly advantageous and is suitable to be connected and integrated, for example, with a manual ventilation balloon from auto- expandable resuscitation.

The invention has the advantage of correcting manual insufflated excess volume; this device, positioned inside the balloon, limits this volume according to different adjustments made by the user on a volume reducer inside the balloon according to the user's setting. The device reducer is placed inside the balloon, e.g. of the self-expanding type, preferably, and its main direction of development is substantially along the central axis of the balloon and forms the main part of the device covered by this application. This device limits the possibility of complete "squeezing" of the balloon at the time of insufflation in order not to exceed volumes that otherwise could cause damage to the respiratory system of the patient.

The use of the device, as an obvious advantage, allows 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 the pulmonary capacity. The advantage of this is the potential reduction in the equipment of emergency or hospital vehicles, since the device makes it ideal to replace the pediatric and neonatal balloons with a single balloon, for example, with a maximum volume of liters.

The invention is also operates as a further advantageous way 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. The advantage of this is the conceptual simplicity of construction and use and the cost of implementation is certainly much lower.

The device referred to in the present application advantageously gives a valid and simple alternative to those who want to limit the volume of manual insufflation in a simple way.

As an additional advantage, the device referred to in this application, in any embodiment, is integrated within the structure of the balloon for example of the self-expandable type becoming an integral part of it, so there is no need for the user to add a physical module before starting the ventilation of the patient, this also makes more streamlined the overall physical structure to be managed manually potentially reducing the weight and size.

In addition, there is a further advantage that consists in the simplicity of the volume limit adjustment by means of the physical subtraction of the internal volume of the manual ventilation balloon by virtue of the partial and variable occupation of the total internal space of the balloon managed by the user. This volume occupation is achieved by virtue of a physical structure of adjustable dimensions positioned inside the said ball.

In a variant embodiment it will be possible to realize a visual scale, as a graduated scale of reference for the user for the most correct regulation of the volume regulator that correlates the occupation of the space inside the balloon occupied by the reducer to the volume of the insufflation that is produced in a more precise way.

The device referred to in this application could also possibly be advantageously integrated into a new production balloon by making the connection with a pre-existing balloon superfluous.

The body of the innovative device, regardless of the chosen design, adapts easily and flexibly to the standard and universal structure of manual ventilation balloons and can be easily integrated with any universal fittings (such as fittings with ventilation devices such as mask, pipe, etc..) placed at the ends of the compressible structure of the balloon (which are not affected in any way) as described and illustrated, or can already be integrated into new production balloons.

Since the identification of the volume of air/oxygen/gas to be injected into the patient's respiratory tree is an exclusively medical act, the device can be conceived in an "advanced" form if it is intended for the hospital/medical sector, i.e. for example with the possibility of setting the volume limits more finely and with greater freedom (e.g. expressed in ml. on the visual reference scale of the setting).

Still, 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), we propose a device that can be set with the indication on the visual scale of reference for setting the physical limit to insufflation with respect to age or weight or, even more simply, with the indication of categories that may potentially be made up of "adult", "pediatric", "infant". These patient classes or volume scales can be associated with clearly visible and distinguishable color choices on that visual scale of choice for the setting of the chosen limit. In this case, the lay / non-expert rescuer should exercise a choice between two or three options, in the same way that 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 tool available that can adapt to each situation.

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

The device does not require a power supply or any source of energy, but only the physical movement of regulation by the operator (for example, called screw or headset solutions).

Particular attention, but not at all discriminating on the conceptual content of the device, should be reserved for the choice of material that preferably should be hypoallergenic and easily sanitized. A disposable type of construction can also be envisaged. The man-object interaction is realized as follows: the user manually adjusts the device limitation regulator (regardless of the chosen embodiment) according to the volume of air that he does not intend to exceed in each insufflation, depending on the type/category of the patient who needs ventilatory assistance and ventilates the latter by compressing the balloon. The device prevents the desired maximum volume parameter from being exceeded.

Further features and advantages of the invention will be further clarified by the detailed description of some preferred, but not exclusive, embodiments of a device for controlling the volume of insufflation according to the present invention.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE PRESENT INVENTION

The present invention will be better specified in terms of purposes and advantages by the following description of two preferred embodiments, illustrated purely by way of non limitative example with reference to the attached drawings in which:

fig. 1 shows the integration between the device in its "cage and screw" form and the balloon, for example, of the self-expanding type;

fig. 2 shows the device in its "cage and screw" form in "minimum volume occupancy" mode, then with the cage minimally expanded, then with the ends of the flexible slats that compose it in the position of maximum distance between them;

fig. 3 shows the device in its "cage and screw" form in "maximum volume occupancy" mode, then with the cage maximally expanded, then with the ends of the flexible slats that compose it in the position of minimum distance between them;

fig. 4 shows the integration between the device in its "air chamber" form and the balloon, for example, of the self-expanding type; in fig. 5 is represented the device in the "air chamber" form in "minimum volume occupancy" mode, therefore with the air chamber minimally expanded (therefore deflated);

fig. 6 shows the device in the "air chamber" form in "maximum volume occupancy" mode, then with the air chamber maximally expanded (therefore inflated).

With reference to figure 1, an embodiment of device 1 is represented in its "cage and screw" form, where the reducer-body 2 of said device 1 is inserted in the manual ventilation balloon 8 (of which here is also represented its connecting part 13 with the ventilation device of the patient such as mask, tube, etc.). This figure shows how device 1, once assembled with the balloon, becomes an integral part of the balloon itself (joining it at its ends by means of the connections/fittings 12a - thereafter described in fig. 2) and is inserted substantially with the main direction of development along the central axis 12, which corresponds to that of the balloon itself.

Device 1 essentially comprises a volume reducer-body 2, in this embodiment the reducer is a "cage" reducer 2a mentioned above, comprising at least two or more flexible slats 4 whose ends are respectively connected in this embodiment to screw 3 and nut 14 which constitute substantially the central axis 12 of the device. The ends of said slats 4, sliding the screw 3 in the nut 14, approach each other producing the volumetric expansion of the cage occupying consequently insufflation volume in the flask. The sliding of screw 3 in the nut 14 is governed by ring nut 9 on which the operator will act, thus modulating the expansion of the "cage" 2a by rotating ring nut 9 in the direction of "internal volume increase" (this reference scale can be marked on the ring nut itself) which will produce a rotation of screw 3 that will approach or move away (in case of reverse rotation) the ends of the cage reducer 2a producing respectively an increase or a reduction of the compressible internal volume of the balloon as described above.

Figure 2 shows the device 1 with representation of the screw 3 and nut 14, of the ring nut 9 for the adjustment of the reducer 2 having cage 2a composed of flexible slats 4, here in closed position (therefore with minimal subtraction of the volume inside the balloon). Note that flexible slats can of course be any number depending on their shape and form of realization, plausibly there are at least two.

This figure shows the advantageous simplicity of the device and the connections at its ends through the connections/joints 12a between this and the auto-expandable balloon. These fittings potentially include a potentially hermetic connection between the extremities of the device's reducer body 2 and the pre-existing balloon, or by means of two elements that are joined, for example, by snapshots or screws to block the circumference of the openings on the extremities of the balloon. These joints 12a fit into the round openings of the flexible and compressible part of the balloon bilaterally and are therefore preferably round and of the same size so that they can be joined together to prevent possible air leakage from unwanted passages. These joints 12a are to be considered optional as the device could be either connected to an existing balloon or, better yet, be advantageously integrated into a balloon that already includes it at birth.

With reference to figure 3, device 1 is shown with the representation of screw 3 and nut 14, of ring nut 9 for the adjustment of the cage reducer 2a composed of the flexible slats 4 (here in open position - therefore with considerable subtraction of the volume inside the balloon) and the connections between the device and the auto-expandable balloon at both ends are highlighted by means of the above described connections/joints 12a; These connections are probably not mobile and the connection they produce between the reducer 2 of device 1 and the auto-expandable balloon does not vary according to the adjustments made by the user but allows the rotation of the ring nut 9 to produce the rotation of screw 3 for the purpose of approaching/removing the ends of the slats that make up the 2nd cage expanding/reducing it.

Figure 4 generically shows the integration between the reducer-body 2b of device 10 in its "air chamber" form 2b and the manual ventilation balloon, e.g. self-expanding 8 (of which here is also represented its connection part 13 with the patient's ventilation device such as mask, tube, etc.), with the presence of the syringe 5 for inflating the air chamber and its duct 11 for said inflating and the relative connection 7 for the syringe 5 described. It is also shown in this figure that device 10 is an integral part of the balloon (joining it at its ends through the connections/joints 12a) and is inserted substantially with the main direction of development along the central axis 12, which corresponds to that of the balloon itself.

The device 10 expands to subtract insufflation volume when desired by the user who will modulate the expansion of the "air chamber" 6 by the criteria of inflating it or deflating it preferably with air with said syringe 5 producing respectively an increase or a reduction of its volume. Here the location and layout of the visual scale for adjusting the inflation of the air chamber is not shown since it is not discriminating.

Figure 5 shows the body 2b of the device 10 with representation of the air chamber 6 deflated (therefore with minimum subtraction of the volume inside the balloon); the syringe 5 for inflation of the air chamber 6 and its duct 11 for said inflation and its described connection 7 for the syringe 5 and the connections between the device and the self-expanding balloon at both ends through the connections/joints 12a are highlighted.

Figure 6 shows the body 2b of device 10 with representation of the air chamber 6 inflated (therefore with considerable subtraction of the volume inside the balloon); the syringe 5 for inflating the air chamber 6 and its duct 11 for the said inflating and its described fitting 7 for the syringe 5 and the conjunctions between the device and the balloon at both ends are highlighted through the fittings/conjunctions 12a.

As mentioned in some variants, this device includes a graduated reference scale for adjusting the volume (Vr) of the device, the device being able to be integrated with any pre or post-production ventilation device.

It is concluded that advantageously this device, physically limiting the vol ume of insufflation, is suitable for a manual ventilation device as a manual ventilation balloon, for example of self-expanding type, with the advantage of using only the adult size.

In addition, therefore, in an even more advantageous way, this device, physi cally limiting the volume of insufflation, is suitable for any type of operator, even inexperienced, and for any type of operational situation.

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

With reference to the way in which this device is used (regardless of its em bodiment form), the following is observed:

- the user sets the volumetric expansion of reducer 2 of device 1 or 10 within a self-expanding balloon with manual adjustment made on the ring nut or with a syringe with reference to a scale or visual medium that indicates the volume limit or category of patient to be ventilated;

- patient ventilation with limitation of balloon compression to the set limit: the physical barrier produced by the device reducer limits "squeezing".

Variations with regard to the construction of the volume reducer and its ad justment for the occupancy of the space/volume inside the manual ventila tion balloon, for example of self-expandable type to limit in a variable and ad justable way the insufflation by means of physical barrier are described as an example and each alternative variant does not conceptually change the purpose of the present invention claimed.

It should be noted, therefore, that the innovative device for limiting the vol ume of manual pulmonary ventilation described in this invention makes it possible to achieve the purpose described above; in addition, in an even more advantageous way, the patient will receive more adequate and stable ventilation assistance even while driving, for example, in an ambulance or rescue vehicle or helicopter, etc. This regardless of the type of road surface, even non-linear or impervious (which normally facilitates inaccuracies in ven tilation).

Variants in size and shape of the device, material in which the various parts are made, external appearance, external functional characteristics of the de- vice, variants in physical parts not substantially useful to modify the use of the innovative device and/or further variants are all to be considered embodi ments included in the object of this invention as better described by the at tached claims.

Claims

1. A device (1) for mechanical limitation of insufflation for a manual ventila tion device (8), said device being integrated with, and positionable inside said ventilation device, characterized by the fact of comprising at least one reducer (2) of the internal volume of said ventilation device (8) and at least one regulator (9) for said reducer, said regulator (9) being manually control lable by a user, said reducer (2) being positioned inside the manual ventila tion device (8), the volume of the reducer (2) increasing or decreasing de pending on the setting of the regulator (9), said reducer (2) being substan tially incompressible, so at the compression of the ventilation balloon it limits the compression of the ventilation device (8) itself opposing mechanical re sistance.

2. The mechanical limiting device (1) according to claim 1, wherein the re ducer (2) in a position (Vr=0) of minimum occupancy of the volume, has a fusiform structure and does not substantially occupy useful volume in the ventilation device.

3. The mechanical limiting device (1) according to the preceding claims, wherein said ventilation device (8) is a self-expanding balloon and/or a bal loon filled with oxygen/gas flow such as an anesthesia balloon and the like.

4. The mechanical limiting device (1) according to the preceding claims, wherein at (Vr>0) the reducer occupies the volume (Vr) in the balloon, the balloon being able to deliver an air volume equal to (Vp-Vr), being (Vp) the total volume of the balloon, therefore the volume of air that can be delivered by the balloon being reduced in proportion to the increase of (Vr).

5. The mechanical limiting device (1) according to the preceding claims, wherein said reducer (2) is a cage reducer (2a) comprising two or more flexi ble slats (4) at least movably connected to a central axis (12).

6. The mechanical limiting device (1) according to the preceding claims, wherein at (Vr=0) said slats (4) are parallel to the central axis (12), with in- creasing of (Vr) the ends of said slats approaching between themselves and said slats bending into the balloon occupying a volume (Vr).

7 The mechanical limiting device (1) according to the preceding claims, wherein said slats (4) of said cage reducer (2a) are two or more and are hinged on the two ends on rings connected ad least slidingly along said cen tral axis (12), at least one of said rings being free to rotate around said cen tral axis (12), or being free slidably on the axis.

8. The mechanical limiting device (1) according to the preceding claims, wherein the central axis (12) consists of screw (3) and nut screw (14), said screw (3) is connected to a an adjustment ring nut for the rotation of the screw, the ring nut being said regulator (9).

9 The mechanical limiting device (1) according to the preceding claims, wherein in case of screwing (Vr>0) the ends of the flexible slats (4) are pushed towards each other, in case of "unscrewing" (Vr tending to 0) the slats return to linear position due to their elastic return or similar.

10 The mechanical limiting device (1) according to claims 1 to 3, wherein said reducer is an air chamber reducer (2) suitable for insertion in said bal loon and suitable for inflating/deflating by said regulator (9), said regulator being a graduated syringe or other means suitable for the same purpose.

11 The mechanical limiting device (1) according to the preceding claims wherein said device includes a graduated reference scale for adjusting the volume (Vr) of the device.

12 The mechanical limiting device (1) according to the preceding claims, wherein the device is adapted to be integrated with any pre or post-produc tion manual ventilation device.