IT202100010982A1 - HELMET FOR THERAPY OF PATIENTS - Google Patents

Description

DESCRIPTION

of the Italian Patent for Industrial Invention entitled:

?HELMET FOR PATIENT THERAPY?

TECHNICAL FIELD

The present invention relates to a helmet (disposable or single-patient) for patient therapy, in particular for continuous positive airway pressure (CPAP) and/or for non-invasive ventilation (NIV).

PRE-EXISTING TECHNIQUE

As ? known, for artificial respiration such as non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) mechanical ventilation, of patients in general, systems are used comprising various types of patient interfaces, such as masks or helmets which, in general, they are adapted to fit tightly to the face or neck of a patient.

Such artificial respiration systems are used to allow breathing for patients who would not be able to breathe on their own or who have difficulty breathing. respiratory or suffer from various pathologies (such as sleep apnea or other).

For this purpose, a mixture of breathable gases, for example air or air enriched with oxygen or pure oxygen, is administered via the patient interface to the patients, having a positive pressure which pushes this mixture into the lungs.

During therapy, the patient therefore has a nose and mouth enclosed within the closed volume defined by the patient interface.

With the use of helmets for patient therapy, on the one hand it improves the efficacy of the therapy and decreases the formation of bedsores on the patient's face, improving the tolerability of the treatment. of the patient interface, but on the other hand the helmets, also including the patient's hearing system within the patient interface, can constitute a barrier around the patient who, therefore, can be feel isolated and can present difficulties? of communication, in entry and exit, with other people, for example medical personnel or others.

A necessity? felt in the sector, therefore, ? those of improving the helmets for the therapy of patients so that they can decrease the isolation of the patient and that allow a more? easy patient communication with the outside world.

EXHIBITION OF THE INVENTION

An object of the present invention ? to satisfy these needs? of the prior art and further needs which will be better described hereinafter, within the context of a simple, rational and low-cost solution.

These purposes are achieved by the characteristics of the invention set forth in the independent claim. The dependent claims outline preferred and/or particularly advantageous aspects of the invention.

The invention, in particular, makes available a helmet for patient therapy comprising:

- a container body in which ? accommodating a patient's head;

- an elastically compliant collar connected to the extremity? bottom of the side wall of the container body and equipped with a passage port with a variable section which can be hermetically coupled to a patient's neck;

- an input connection, in which the input connection ? adapted to be connected to a source of a breathing gas under pressure for the introduction of breathing gas under pressure inside an internal volume enclosed by the container body and by the collar;

- an outflow fitting for the gases exhaled by the patient from the internal volume; - a communication system equipped with an emitter device configured to emit a sound audible to the patient within the internal volume and a microphone configured to receive a sound emitted by the patient within the internal volume.

Thanks to this solution, the helmet for patient therapy allows the patient undergoing therapy to be able to communicate easily with the outside world and not feel isolated inside the helmet.

According to one aspect of the invention, the emitter device can comprising an electromechanical (e.g., bone conduction) transducer configured to convert an electrical signal into a mechanical vibration.

Thanks to this solution, the patient can receive the sounds through the emitter device maintaining the clarity/sharpness of the sound even in the very noisy environment defined by the internal volume of the helmet (in which the gas flows are particularly turbulent) and, moreover, the patient can? also wear hearing protection, such as plugs or other devices that dampen the noise of the gas flow. Alternatively, the emitter device can? comprising an electro-pneumatic transducer configured to convert an electrical signal to a pneumatic signal.

Again, at least one between the emitter device and the microphone or both of them ? rigidly connected to at least one inner wall or one outer wall of the container body.

Thanks to this solution, the helmet can? serve as a sounding board and transmission of the sound emitted by the emitter device or to be received by the microphone.

Advantageously, one of the emitter device and the microphone or both of them can be placed inside the internal volume, preferably wearable on the patient's head

According to a further aspect of the invention, the communication system can include a connector connected to the emitter device and to the microphone, where the connector ? arranged externally to the internal volume or reachable from the outside of the helmet.

According to the invention, the communication system can comprising an interface device able to be connected, preferably in a removable way, to the emitter device and/or to the microphone.

For example, the interface device can? include an intercom system equipped with:

- an external microphone configured to receive a sound from outside the internal volume and transmit it to the emitter device; and/or

- an external emitter device configured to receive a signal from the microphone representative of the sound emitted by the patient and convert this signal into a sound emitted outside the internal volume.

Alternatively or in addition, the interface device can? include a telecommunications device (such as a mobile phone, smartphone, tablet or similar).

Alternatively or in addition, the interface device ? integrated in a control device (monitoring of breathing gases and/or exhaled gases (so-called monitor) connected to the inlet connection and/or outflow connection of the helmet A further aspect of the invention, which can be protected independently of the above described, makes available a communication system comprising an emitter device equipped with an electromechanical bone conduction transducer and a support configured to support the emitter device on a user's head (for example near a bone of the head), in which the support comprises an adhesive device, for example an adhesive patch, configured to support the emitter device by adhesion (through a suitable biocompatible glue) on a portion of the user?s head (for example a portion of the user?s skin, preferably in a temporal region of the same anterior to the ear).

For example, the communication system comprises a microphone equipped with a further support, in which this further support is configured to support the microphone on a user's head (for example near the mouth and/or neck), in which the? further support comprises a further adhesive device, for example an adhesive patch, configured to support the microphone by adhesion (through a suitable biocompatible glue) on a portion of the user?s head (for example a portion of the user?s skin, preferably in a area of the neck or face proximal to the mouth).

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the invention will become apparent from reading the following description provided by way of non-limiting example, with the aid of the figures illustrated in the attached tables.

Figure 1 ? a front view of a helmet, according to a first embodiment of the invention.

Figure 2 ? a side view of figure 1.

Figure 3 ? a front isometric view of a helmet, according to a second embodiment of the invention.

Figure 4 ? a front view of a helmet, according to a third embodiment of the invention.

Figure 5 ? a front view of a helmet, according to a fourth embodiment of the invention.

Figure 6 ? a front view of a helmet, according to a fifth embodiment of the invention.

BEST WAY TO CARRY OUT THE INVENTION

With particular reference to these figures, yes? globally indicated by 10 a system for the respiratory therapy of patients.

System 10 includes a patient interface configured to make available a breathing gas under pressure to a patient's respiratory system.

The patient interface? for example constituted by a helmet 20, which ? configured to surround an internal volume within which ? received the entire head of the patient (including his hearing system).

In particular, the helmet 20 comprises a substantially cylindrical container body 21.

The container body 21, for example, comprises a side wall (closed on itself in a ring around a central axis), which has a substantially cylindrical shape.

The side wall has an extremity upper (axial) and one extremity? lower axially opposed to the extremity? superior.

The side wall is, for example, made of an optically transparent material which, although flexible, is not expandable, for example polyvinyl chloride (PVC), preferably free of phthalates.

The container body 21 also comprises an upper closing disc, which closes the end? superior lateral wall.

The upper closing disk is, for example, circular and has a perimetric edge which seals together at the extremity. superior lateral wall.

The upper closure disc is, for example, made of an optically transparent material which, although flexible, does not result in expansion, for example Polyvinylchloride (PVC), preferably free of phthalates.

The helmet 20 also comprises an elastically yielding collar 24, which can be hermetically coupled to the patient's neck and adapted to be connected hermetically to the end of the helmet. bottom of the side wall of the container body 21.

The container body 21 and the collar 24 delimit an internal volume (closed on the patient's neck) within which ? received the patient's head and which defines the breathing environment of the same.

The collar 24 is advantageously made of an elastically yielding material, for example of Polyurethane (PU), preferably free of phthalates and/or silicones, to be coupled tightly to the patient's neck.

The collar 24, in practice, has a substantially truncated cone shape, and is provided with a first end? (enlarged) and a second extremity? (tapered) open.

In particular, the first end? of the collar 24 has a diameter substantially equal to the diameter of the end? open bottom of the side wall of the container body 21 to which said collar 24 ? (for example, permanently) fixed, while the second end, smaller than the first end, has a diameter comparable to or slightly smaller than the diameter of the patient's neck.

The second end? of the collar 24 ? devoid of any occlusion element (i.e. it does not have valves or closing flaps or other occlusion system of the same).

In some embodiments, shown in Figures 1, 2 and 4-6, the helmet 20 can be of the closed type.

In the helmets 20 of the closed type, the container body 21 is closed by collar 24 at the extremity? bottom of the side wall and by the upper closing disc at the end? superior lateral wall.

In a first variant of the helmet 20 of the closed type (not shown), the collar 24 (that is, its first end) can be fixed directly to the container body 21 by means of fixing techniques such as heat-sealing or other techniques. For example, in this case the helmet 20 has no rigid structural parts (such as rings or other which, due to their structure, would maintain their proper shape if subjected to manual bending).

In a second variant of the closed-type helmet 20 (see figures 1,2, 4-6), between the collar 24 (or its first end?) and the container body 21 (or the lower end of the side wall) can? a rigid ring 25, for example flat circular or shaped (for example saddle-shaped), may be interposed.

The rigid ring 25, for example, ? such that it cannot be folded or altered in shape without causing breakage and ? such as to maintain its annular shape both when ? in use that when not ? in use.

Furthermore, in closed-type helmets, the upper closing disc is? (directly and) rigidly connected to the extremity? top of the lateral wall, irremovably.

In other possible embodiments, shown in figure 4, the helmet 20 can be for example of the openable type.

In helmets 20 of the openable type, at least one between the collar 24 and the upper closing disc (or both of them)? connected to the side wall in a removable way, respectively at the extremity? lower or at the end? superior of the lateral wall itself.

In this case, the (perimeter edge of the) upper closing disc ? fixed to the (upper end of the) side wall in a removable way and/or the end? bottom of the side wall ? fixed at the first end? of the collar 24 in a removable way.

In particular, the (perimeter edge of the) upper closing disc ? fixed to the (upper end of the) side wall in a removable way and/or the end? bottom of the side wall ? fixed at the first end? of the collar 24 by means of a fastening system that can be sealed.

For example, the (perimeter edge of the) upper closing disc or the? bottom of the side wall ? connected/rigidly fixed (for example coaxially) to a first rigid ring 26, for example by heat-sealing or other fixing technique which guarantees the hermetic and stable seal between the two. In turn, the (upper end of the) side wall or the first end? of the collar ? connected/rigidly fixed (for example coaxially) to a second rigid ring 27, for example by heat-sealing or other fixing technique which guarantees the hermetic and stable seal between the two.

The second rigid ring 27 ? configured to be coupled in a resolvably sealed manner, to the first rigid ring 26, as will appear in the following description, so that the first rigid ring 26 (and with it the upper closing disc) can be (repeatedly) coupled and decoupled from the second rigid ring 27 (or from the side wall of the container body 21).

The helmet 20 can? further comprise an annular gasket (attached to one of the first rigid ring 26 and the second rigid ring 27), which ? compressed (axially) between the first rigid ring 26 and the second rigid ring 27 when the helmet 20 is in closed assembly configuration (ie when the upper closing disc, and with it the first rigid ring 26, is coupled to the side wall, ie to the second rigid ring 27).

The helmet 20 also comprises a resolvable fastening (or blocking/hooking) system, which ? configured to mutually constrain, in a removable way, the first rigid ring 26 and the second rigid ring 27.

The fixing system, preferably, ? chosen in the group between bayonet hooks, snap hooks and threaded hooks.

In particular, in the embodiment shown in figure 3, the first rigid ring 26 and the second rigid ring 27 can be connected to each other by means of a fastening system of the type of a bayonet coupling.

The bayonet coupling, in particular, comprises two coupling elements which are respectively associated with the first rigid ring 26 and with the second rigid ring 27.

The hooking elements comprise a plurality of pins 270, for example fixed to a lateral surface of the second rigid ring 27 and protruding radially outward from it (for example equidistant from each other).

The hooking elements also comprise a plurality of of housing seats 260, for example formed in the first rigid ring 26, (equi)spaced from each other so that each of them is such as to accommodate a respective pin 270 of the second rigid ring 27.

In practice, each pin 270 ? adapted to be inserted in a removable way in a housing seat 260 following a contained reciprocal translation-rotation between the first rigid ring 26 and the second rigid ring 27.

In greater detail, the second rigid ring 27 ? capable of being inserted substantially to measure inside the first rigid ring 26, in a coaxial way.

Each housing site 260 ? shaped like an elongated slot (substantially ?L?) which defines a first open portion, at the lower edge of the first rigid ring 26, capable of allowing access to the pin 270.

The first portion has an inclination with a prevalent direction parallel to the central axis of the container body 21 (ie of the first rigid ring 26 and of the second rigid ring 27).

Each housing seat 260 also comprises a second portion, consecutive to the first, which ? inclined, for example squared, with respect to the first section with a prevailing circumferential direction.

Each second section defines an engagement portion (the lower wall of the second section or both walls of the second section itself), for example concave or rectilinear, in which ? can one of the pins 270 be housed stably when the helmet 10 ? in the assembled configuration, i.e. when the first rigid ring 26 and the second rigid ring 27 are stably coupled to each other.

On the sides of at least two housing seats 260, diametrically opposite each other, there are radial gripping protrusions which branch off radially from the first rigid ring 26.

The rotational actuation of the first rigid ring 26 with respect to the second rigid ring 27, for mutual engagement and release, is facilitated by the radial protrusions of the grip, each of which? fit to be engaged by a finger of the operator that with an opposite finger can? engage the pin 270 inserted in the housing seat 260 proximal to the radial grip protrusions (to actuate the sliding of the pin 270 in the second section of the housing seat 260, in the two sliding directions, respectively to engage or disengage the reciprocal connection between the first rigid ring 26 and the second rigid ring 27). The helmet 20 also comprises means for introducing a breathable gas, for example air (or a mixture of air and oxygen or oxygen), inside the internal volume enclosed by the container body 21 and by the collar 24.

In particular, the input means comprise or consist of an input fitting 30 for the input of the breathing gas (for example of standard dimensions for connection to usual breathing gas input pipes such as air, air and oxygen or oxygen, Venturi meters or similar devices, connected in turn to a source of breathing gas).

The input fitting 30, for example, has a? internal suitable to be arranged inside the internal volume enclosed by the container body 21 and by the collar 24, in which the end? internal?, for example, equipped with a diffuser (equipped with radial openings).

Furthermore, the inlet fitting 30 has an? external, which ? arranged outside the internal volume enclosed by the container body 21 and by the collar 24, which is defined by a circular tubular portion of the aforementioned standard dimensions, for example 22F or 22M.

Advantageously, the inlet connection 30 ? (arranged at the e) fixed (for example rigidly, preferably by heat-sealing) to at least one of the container body 21 (or the upper closing disc or the side wall), the collar 24, the rigid ring 25 (where provided ), the first rigid ring 26 or the second rigid ring 27 (where provided).

For example, the helmet 20 and/or the breathing gas source comprises a venturi effect oxygen-air mixer (or venturi meter) fixed (removably or permanently) to the inlet fitting 30 (or to the outer end thereof), through which the breathing gases per patient enter the internal volume enclosed by the helmet 20.

Preferably, the helmet 20 pu? comprise an antiviral/antibacterial filter configured to filter the air sucked in by the oxygen-air mixer with a venturi effect (by venturi effect) and which defines the breathable gas to be introduced into the internal volume enclosed by the helmet 20 which enters from the inlet fitting 30.

The helmet 20 also comprises means for the outflow of the gases exhaled by the patient towards the outside of said internal volume enclosed by the container body 21 and by the collar 24.

In particular, the outflow means comprise or consist of an outflow fitting 40 of the gases exhaled by the patient in respiration (for example of standard dimensions for connection to usual PEEP pipes or valves or other similar devices).

For example, the outflow fitting 40 has an air intake suitable for being connected to a measuring instrument, such as a manometer for measuring the pressure inside the helmet 10.

The outflow fitting 40, for example, has a? internal suitable to be arranged inside the internal volume enclosed by the container body 21 and by the collar 24, in which the end? internal?, for example, equipped with a diffuser/manifold (equipped with radial openings).

Furthermore, the outflow fitting 40 has a? external, which ? arranged outside the internal volume enclosed by the container body 21 and by the collar 24, which is defined by a circular tubular portion of the aforementioned standard dimensions, for example 22F or 22M.

Advantageously, the outflow fitting 40 is (arranged at the e) fixed (for example rigidly, preferably by heat-sealing) to at least one of the container body 21 (or the upper closing disc or the side wall), the collar 24, the rigid ring 25 (where provided ), the first rigid ring 26 or the second rigid ring 27 (where provided).

For example, the helmet 20 comprises (as illustrated only in figure 1) a PEEP valve 45 fixed (removably or permanently) to the outflow fitting 40 (or to the outer end thereof), through which the gases exhaled from the patient in breathing (and ensures that a given positive pressure? fixed or adjustable? always remains within the internal volume enclosed by the helmet 20).

Preferably, the helmet 20 pu? include a viral/bacterial filter configured to filter the patient's exhaled gases in the breath exiting the outflow port 40 and/or the PEEP valve 45.

The system 10 also comprises an anti-suffocation valve 50 (see figures 3 and 4) associated with the helmet 20.

The anti-choke valve 50 ? a bidirectional valve, configured to place the internal volume enclosed by the container body 21 and by the collar 24 in communication with the outside (in both directions), in case of emergency (or whenever the internal pressure of this internal volume drops below predetermined limit pressure value between the ambient pressure value and the operating pressure value set by the breathing gas source).

For example, the 50 ? adapted to open when the inlet fitting 30 is disconnected (accidentally) from the source of the breathing gas or when this does not deliver sufficient breathing gas to ensure the desired operating pressure for patient therapy).

The anti-choking valve 50 is, for example, fixed (permanently or removably) to at least one of the container body 21 (or the upper closing disc or the side wall), the rigid ring 25 (where provided ), the first rigid ring 26 or the second rigid ring 27 (where provided).

For example, the anti-choking valve 50 can? be of the bidirectional type of the type described in the patent EP 1797 925 in the name of the same Applicant (or as described in any of the patent applications n. 102020000022645, 102020000022672 and 102020000022696 in the name of the same Applicant).

For example, the anti-choking valve 50 can? be rigidly fixed directly to at least one of the container body 21 (i.e. the upper closing disc or the side wall), the rigid ring 25 (where provided), the first rigid ring 26 or the second rigid ring 27 (where provided) .

Alternatively, the anti-choke valve 50 can? be arranged on a closing door associated in a removable way (for example by means of a threaded or bayonet connection or by interference or other fixing system) to a fixing tang arranged in correspondence with at least one of the container body 21 (i.e. the upper disk closure or the side wall), the rigid ring 25 (where provided), the first rigid ring 26 or the second rigid ring 27 (where provided).

The system 10 also comprises retention means 60 (see figure 2) able to exert a pulling action on the helmet 20.

The retention means 60 exert the pulling action towards the patient's shoulders with the function of preventing the helmet 20 from rising due to the positive pressure inside the same.

These retention means 60 can be of the type with ?axillary straps? or ?tie rods? as known to the expert in the sector.

These retention means 60 are able to be fixed (removably or permanently) to suitable fastening elements, such as pegs, eyelets, buckles or the like, which are rigidly fixed to the container body 21, for example at at least one of the side wall and the upper closing disk, the rigid ring 25 (where provided), the first rigid ring 26 or the second rigid ring 27 (where provided).

Alternatively or additionally, such retaining means 60 may comprise an internal/external cushion which is? inflatable for example from the outside and which facilitates the contact area with the patient's neck.

Said pillow can be positioned, for example, below the collar 24.

In this way a stiffening of the structure of the helmet 20 is obtained which prevents the deformation of the collar 24 and consequently prevents both the upward displacement effect of the helmet 20 and the variation of the internal volume enclosed by the body from being created container 21 and collar 24.

The internal/external cushion thus exerts an optimal seal on the patient's neck, avoiding the need for a cushion. of use of ?underarm braces? or ?rods? and/or reducing the shooting action they exercise.

Again, alternatively or in addition to the cushion, these retention means 60 can comprise ? as it is known ? a rigid base, as described in the patent n. EP237616 by the same Applicant.

The helmet 20 can? also include one or more accessory-holder fittings, for example fittings 55 passing cables/catheters passing (SNG), which can be arranged in correspondence with at least one of the collar 24, the container body 21 (or the side wall or the upper closing disc), the ?rigid ring 25 (where provided), the first rigid ring 26 or the second rigid ring 27 (where provided).

Again, helmet 20 pu? include a pressure relief valve.

Again, helmet 20 pu? include an accessory cushion, which can be positioned inside the internal volume enclosed by the container body 21 and the collar 24. This accessory cushion can? be configured to be placed under the patient's neck when this ? positioned in a supine lying position and/or below the patient's forehead and/or chin when this is positioned in a prone lying position and/or under one side of the patient's head when this is positioned in a lying position on its side.

According to the invention, the helmet 20 comprises a communication system 70 configured to put into communication (auditory) the patient wearing the helmet 20 (that is, whose head is arranged inside the internal volume enclosed by the container body 21 and by the collar 24) with the outside of the helmet 20.

The communication system 70 preferably includes an emitter device 71 configured to emit a sound audible to the patient within the internal volume.

For example, the emitter device 71 ? chosen from the group consisting of an earpiece, a headset, a speaker, a loudspeaker or combination thereof.

The emitter device 71 in a first possible embodiment comprises or ? consisting of an electromechanical transducer configured to convert an electrical signal into a mechanical vibration.

In this helmet, for example, the emitter device 71 is configured to emit a mechanical vibration representative of an audio (electrical) signal and reproduce the sound via the emitted mechanical vibration.

Preferably, the electromechanical transducer ? of the bone conduction type, ie ? configured to deliver sound to the patient?s (inner) ears by conducting sound through the patient?s (skull) bones. In an alternative embodiment, the emitter device 71 comprises or ? consisting of an electro-pneumatic transducer configured to convert an electrical signal into a pneumatic signal.

In this helmet, for example, the emitter device 71 is configured to output a pneumatic signal representative of an audio (electrical) signal and reproduce the sound via the output pneumatic signal.

It is not excluded that the emitter device 71 may be of a different type, for example, comprising or being constituted by any electroacoustic transducer configured to convert an electrical signal into an acoustic signal and configured to reproduce the sound through the emitted acoustic signal; for example the emitter device 71 could be of the electronic or other type, according to requirements.

Preferably, the emitter device 71 comprises a pair of emitters (one right and one left), one for each ear of the patient.

However, it is not excluded that the emitter device comprises a single emitter (for a single patient's ear).

In a first embodiment shown in figures 1-4 and 6, the emitter device 71 is configured to be worn on the patient's head enclosed in the internal volume of the helmet 20.

For example, the emitter device 71 ? arranged inside the internal volume of the helmet 20 and ? in contact with at least a portion of the head of the patient (who is wearing the helmet 20).

For example, the emitter device 71 can? be supported directly by the patient's ears, for example each emitter can? be at least partially inserted into the auricle of the respective ear in order to be supported there.

Alternatively or in addition, the emitter device 71 can be supported by the patient's head by means of a support 710.

Preferably, the 710 support can? comprise or consist of a headband, for example elastically flexible and/or adjustable in width/length, configured to support one or both emitters of the emitter device 71.

In this helmet, the support 710 ? configured to be anchored to the patient's head, for example fitted on it, so that the emitter device 71, or each emitter of the same, is arranged in correspondence with or near the patient's head. of the patient's ear.

Alternatively, the 710 support can? comprise or consist of a single headband, for example elastically flexible and/or adjustable in width/length, configured to support a single emitter of the emitter device 71 and configured to at least partially embrace a single patient's ear, for example an upper outer portion ( or internal) of the auricle of the same.

Alternatively or in addition, moreover, the support 710 pu? comprise or consist of an adhesive device, such as an adhesive patch, configured to support each emitter (e.g. individually) by adhesion (by means of a suitable biocompatible adhesive) on a portion of the patient's head (e.g. a portion of the patient's skin , preferably in a temporal region of the same anterior to the ear or in correspondence with the auricle of the same).

For example, the 710 support can? present an adhesive device for each emitter of the emitter device 71.

In the event that the emitter device 71 (or each emitter thereof) is of the bone conduction type, the support 710 (of any type described above) ? configured to exert a pressure (not zero) on each emitter so as to keep it pressed (forcefully) against the portion in contact with the patient's head (for example a temporal region of the same anterior to the ear).

In a further (and alternative) embodiment shown in figure 5, the emitter device 71 is configured to be fixed, for example, in a removable or permanent way to the helmet 20, for example to the container body 21 thereof, preferably with each emitter of the emitter device 71 in contact with at least a portion of the helmet 20, or of the container body 21.

In the illustrated examples, the emitter device 71, or each emitter thereof, is connected to the lateral wall of the container body 21, for example in a lateral position (so as to be able to be radially aligned with an ear of the patient wearing the helmet 20).

However, it is not excluded that the emitter device 71, or each emitter thereof, may be connected to the upper closing disc of the container body 21 or to any part of the helmet 20, such as for example to the rigid ring 25 (where provided), to one of the first rigid ring 26 and to the second rigid ring 27 (where provided) or to the collar 24 (or other accessory of the helmet 20).

The emitter device 71, in this further embodiment (of figure 5), is configured to transmit the emitted sound to the patient's ear via the container body 21 (or the side wall and/or the upper closing disc of the same), so that the latter acts as a resonance and propagation house for the emitted sound from each emitter of the emitter device 71.

For example, the emitter device 71 (or each emitter thereof) ? configured to transmit a sound to the portion of the helmet 20 to which ? applied and, from this, propagate it within the internal volume so that it is audible to the patient wearing the helmet 20.

Preferably, the emitter device 71 is placed inside the internal volume, or in contact with an internal wall of the container body 21 (or of the side wall and/or of the upper closing disc thereof) or of any part of the helmet 20, such as for example the rigid ring 25 (where provided), one between the first rigid ring 26 and the second rigid ring 27 (where provided) or the collar 24 (or other accessory of the helmet 20).

Alternatively, the emitter device 71 can be placed outside the internal volume, i.e. in contact with an external wall of the container body 21 (or the side wall and/or the upper closing disc thereof) or any part of the helmet 20, such as for example the rigid ring 25 (where provided), one between the first rigid ring 26 and the second rigid ring 27 (where provided) or the collar 24 (or other accessory of the helmet 20).

For example, the emitter device 71 can? be fixed permanently (for example by welding or other permanent fixing technique) to the helmet Alternatively, the emitter device 71 can? be removably attached to the helmet 20, for example by a removable/resolvable connection system, such as a gluing (adhesive patch) system, a threaded or bayonet or interlocking fastening system or the like.

The communication system 70 further comprises a receiving device, such as for example a microphone 72, which is configured to receive an audible sound from the patient whose head ? placed inside the internal volume.

The microphone 72 in a first possible embodiment comprises or ? consists of a transducer configured to convert sound energy into electrical energy. In this helmet, for example, the microphone? configured to receive a sound signal and convert it into an electrical signal.

Preferably, the transducer can? be of an electronic or electromechanical or electropneumatic type or otherwise.

In a first embodiment, the microphone 72 ? configured to be worn on the patient, for example near? of the head enclosed in the internal volume of the helmet 20.

For example, the microphone ? arranged inside the internal volume of the helmet 20 and ? in contact with at least a portion of the head or neck of the patient (who is wearing the helmet 20), near of the mouth.

For example, microphone 72 can? be supported by the patient's head or neck, for example in the vicinity? of the mouth, by means of a support 720.

The support 720 pu? be defined integral with or fixed to the support 710 or be distinct from it.

For example, support 720 pu? comprise or consist of an adhesive device, for example an adhesive patch, configured to support the microphone 72 by adhesion (through a suitable biocompatible adhesive) on a portion of the patient's head or neck (for example a portion of the patient's skin, preferably in a region of the face near the patient's mouth).

In a further (and alternative) embodiment shown in Figures 1-6, the microphone 72 is configured to be fixed, for example, in a removable or permanent way to the helmet 20, for example to the container body 21 of the same, preferably in contact with at least a portion of the helmet 20, or of the container body 21.

In the examples shown, the microphone 72 ? connected to the lateral wall of the container body 21, for example in a frontal position (so as to be able to be radially aligned with the mouth of the patient wearing the helmet 20).

However, it is not excluded that the microphone 72 can be connected to the upper closure disk of the container body 21 or to any part of the helmet 20, such as for example to the rigid ring 25 (where provided) to one of the first rigid ring 26 and to the second rigid ring 27 (where provided), to the collar 24 (or other accessory of the helmet 20).

The microphone 72, in this second embodiment, is configured to receive the sound emitted by the patient's mouth through the internal volume of the helmet and/or the container body 21 (i.e. the side wall and/or the upper closing disc of the same), which acts as a resonance and propagation house for the sound emitted by the patient himself.

For example, microphone 72 can? be permanently attached (e.g. by welding or other permanent attachment technique) to the helmet 20.

Alternatively, microphone 72 can? be removably attached to the helmet 20, for example by a removable/resolvable connection system, such as a gluing (adhesive patch) system, a threaded or bayonet or interlocking fastening system or the like.

Preferably, microphone 72 ? placed inside the internal volume, or in contact with an internal wall of the container body 21 (or of the side wall and/or of the upper closing disc thereof) or of any part of the helmet 20, such as for example the rigid ring 25 (where provided), one between the first rigid ring 26 and the second rigid ring 27 (where provided) or the collar 24 (or other accessory of the helmet 20).

However, it is not excluded that the microphone 72 can be placed outside the internal volume, i.e. in contact with an external wall of the container body 21 (or the side wall and/or the upper closing disc thereof) or any part of the helmet 20, such as for example the rigid ring 25 (where provided), one between the first rigid ring 26 and the second rigid ring 27 (where provided) or the collar 24 (or other accessory of the helmet 20).

The communication system 70 also comprises at least one connector 73, which ? connected to the emitter device 71 and to the microphone 72.

Connector 73 ? for example an electrical connector, configured to transmit electrical signals (for example at least one first electrical signal directed towards the emitter device 71 and at least one second electrical signal emitted by the microphone 72).

Connector 73 ? for example connected to the emitter device 71 and to the microphone 72 by at least one connection cable 74 configured to transmit the electrical signal from the connector 73 to the emitter device 71 and from the microphone 72 to the connector 73.

It is not excluded that the connection between the connector 73 and the emitter device and the microphone 72 could be of the wireless type (ie wireless), for example radio waves.

Preferably, connector 73 ? arranged externally to the internal volume or, in any case, reachable from the outside of the helmet 20.

It is not excluded that (as illustrated in figure 5) the whole connection system 70 may be arranged externally to the helmet 20 (or a portion of it may be arranged externally to the helmet and a further portion may be arranged inside the internal volume of the helmet 20 ).

For example, connector 73 can? be of the type of a jack or light-in or USB connector (male or female) or other standard connector.

The helmet 20 can? be equipped with a through opening, for example made in the container body 21 or in the collar 24 (or in any other suitable place such as the rigid ring 25 where provided, the first rigid ring 26 and/or the second rigid ring 27 where provided) , which ? adapted to put the exterior of the helmet 24 in communication with said internal volume.

In this case, at least a portion of the connector 73 or of the connection cable 74 (where provided) ? sealed connected to said through opening of the helmet 20.

The connector 73, in a first possible embodiment shown in the figures, is disposed (totally) outside the helmet 20 (ie external to the internal volume of the helmet 20).

In this embodiment 73, for example, the connection cable 74 (where provided) ? inserted into the through opening of the helmet 20, making a sealed connection therewith.

For example, the through opening can? be defined by the second end? opening of the collar 24 (which defines the passage opening in which the patient's neck is inserted hermetically).

Alternatively or in addition, the through opening can? be defined by a cable pass/catheter pass (SNG) fitting 55, as shown in Figure 4, which ? fixed to at least one of the container body 21 (for example the side wall or the upper closure disc), the collar 24, the rigid ring 25 (where provided) and the first rigid ring 26 and/or the second rigid ring 27 (where provided).

Alternatively or in addition, the through opening can? be defined by a dedicated fitting fixed to at least one of the container body 21 (for example the side wall or the upper closing disc), the collar 24, the rigid ring 25 (where provided) and the first rigid ring 26 and/ or the second rigid ring 27 (where provided). In an alternative possible embodiment, the connector 73 can? be rigidly fixed to the case 20, i.e. to the internal edge of the through opening (so as to be accessible from the outside of the helmet 20 (for the electrical connection of the same).

The connection system 70 then comprises an interface device 75 adapted to be connected, preferably in a removable way, to the emitter device 71 and/or to the microphone 72.

For example, the interface device 75 ? has a respective connector able to be connected (mechanically and electrically) to the connector 73.

However, it is not excluded that the interface device 75 can be connected to the emitter device 71 and/or to the microphone 72 in mode? cordless (i.e. wireless), such as using radio waves.

In one embodiment shown in Figures 1 and 6 , the interface device 75 comprises or ? consisting of an intercom system.

In this case, the interface device 75 (i.e. the intercom system) comprises an external microphone 750 configured to receive a sound from outside the internal volume of the helmet 20 and transmit it to the emitter device 71 (for example via the connector 73 and the cable of connection 74).

Alternatively or additionally, the interface device 75 (i.e. the intercom system) comprises an external emitter device 751 configured to receive a signal from the microphone 72 representative of the sound emitted by the patient (for example via the connecting cable 74 and the connector 73 ) and convert this signal into a sound emitted outside the internal volume.

The 751 external emitter device ? for example of the type of a speaker or loudspeaker configured to emit a sound (for example at a higher volume than that perceived by the microphone 72.

Therefore, the patient given that his head is contained in the helmet 20 ? enabled to communicate (incoming and outgoing), or to hear what? which is communicated to him from the outside and to be heard outside the helmet 20, via the interface device 75.

Furthermore, the communication system 70 can? comprising at least one filter configured to filter the signals.

For example, the filter can? be associated with at least one of the emitter device 71, the microphone 72 and/or the interface device 75 (that is, with at least one of the external emitter device 751 and the external microphone 750).

For example, the filter ? configured to reduce/muffle the (disturbance) noise, for example the noise defined by the flow of gases generated by the helmet 20 and/or by the breathing gas source and/or by the outflow means of the gases exhaled by the patient. Alternatively or in addition to what has been described above, the interface device 75, as shown in figure 1, can include a telecommunications device 752, for example a mobile or semi-mobile device, such as a cell phone, smartphone, tablet, personal computer, and/or stationary device (such as a personal computer).

For example, interface device 75, or telecommunication device 752, may be integrated into a breathing gas and/or exhaled gas control device 755 (so-called monitor) connected to the inlet connection and/or the outflow connection.

The 755 controller ? a device configured to monitor (through dedicated sensors) some breathing parameters of the patient wearing the helmet 20, such as for example the concentration and/or the quantity? of carbon dioxide of the gas exhaled by the patient, the concentration and/or quantity? of oxygen of the breathing gas, the pressure of the gases inside the internal volume of the helmet 20, the temperature of the gases inside the internal volume of the helmet 20 or other and combination thereof.

The interface device 75, or the telecommunication device 752, ? preferably equipped with a display and/or a processor, for example equipped with a? unit? of memory, in which ? installable or installed at least one program (software).

The interface device 75, or the telecommunication device 752, ? preferably equipped with or connectable to a microphone and/or emitter device (such as a speaker or loudspeaker).

The interface device 75, or the telecommunication device 752, ? configured to receive a sound from outside the internal volume of the helmet 20 (via the microphone of the same).

The program of the interface device 75. or of the telecommunication device 752, can? be programmed to switch the received sound into at least one electrical signal and transmit the switched electrical signal to at least one between the emitter device 71 (for example via the connector 73 and the connecting cable 74) and the display.

For example, if the switched electrical signal is sent to the emitter device 71, the latter will transduce? the electrical signal into a sound to be made audible by the patient wearing the helmet 20.

In the event that the switched electrical signal is sent to the display of the telecommunication device 752, the latter will transduce? the electrical signal in a written message visible to the patient wearing the helmet 20.

Furthermore, the interface device 75, i.e. the telecommunication device 752, is configured to receive an electrical signal from the microphone 72 representative of the sound emitted by the patient (for example via the connection cable 74 and the connector 73).

The program of the interface device 75, or of the telecommunication device 752, can be programmed to process the received electrical signal to transmit the processed electrical signal to at least one of the emitter device (of the telecommunication device 752) and the display.

For example, in the event that the processed electrical signal is sent to the emitter device (of the telecommunication device 752) the latter will transduce? the electrical signal processed into a sound to be made audible by the personnel consulting the interface device 75 (located externally to the helmet 20).

In the event that the processed electrical signal is sent to the display of the telecommunication device 752, the latter will transduce? the electrical signal in a written message visible by the personnel who consult the interface device 75 (located externally to the helmet 20) and/or sent to another remote mobile device.

The communication system 70, as shown in figure 6, can furthermore comprise a further interface device 76 able to be connected to the interface device 75, which is for example given to the personnel in charge of taking care of the patient who wears the helmet 20.

The further interface device 76 can? be, for example, connected or connectable (automatically) in mode? wireless (ie wireless), for example by radio waves, to the interface device 75 (for example when they are within a predetermined connection radius, for example of 2-5 m).

The further interface device 76 for example comprises or ? consisting of an intercom system.

In this case, the further interface device 76 (ie the intercom system) comprises an external microphone and an external emitter device, in which the microphone is? configured to receive a sound emitted by personnel to whom ? supplied data and transmit it to the emitter device so that? reproduces the sound emitted by the personnel, for example by amplifying it, and directing it to the external microphone of the patient interface 75.

In the light of the foregoing, does system 10 operate? the following. When the patient is receiving respiratory therapy via the helmet 20, his head, as well as such as his hearing system and his mouth) ? completely enclosed within the internal volume of the helmet 20.

In this case, the patient wearing the helmet 20 can continue to communicate with the exterior of the helmet 20 (for example with the personnel assigned to care or with remote people) via the communication system 70 of the helmet 20.

In particular, the communication system 70 ? configured to pick up the sound emitted by the patient?s voice and transmit this sound (or a visible message) outside the helmet 20 and, at the same time, to pick up the sound emitted by the voice of a person outside the helmet 20 and transmit this sound (or a visible message) inside the internal volume of the helmet 20 where ? contained the patient's head.

The invention so? conceived ? susceptible to numerous modifications and variations, all of which are within the scope of the inventive concept.

Furthermore, all the details can be replaced by other technically equivalent elements. In practice, the materials used, as well as? the contingent shapes and dimensions may be any according to requirements without thereby departing from the scope of protection of the following claims.

Claims (10)

1. A patient therapy helmet comprising: - a container body in which ? accommodating a patient's head; - an elastically compliant collar connected to the extremity? lower part of the container body and equipped with a passage opening with a variable section which can be coupled hermetically to a patient's neck; - an input connection, in which the input connection ? adapted to be connected to a source of a breathing gas under pressure for the introduction of breathing gas under pressure inside an internal volume enclosed by the container body and by the collar; - an outflow fitting for the gases exhaled by the patient from the internal volume; - a communication system equipped with an emitter device configured to emit a sound audible to the patient within the internal volume and a microphone configured to receive a sound emitted by the patient within the internal volume. The helmet according to claim 1, wherein the emitter device comprises an electromechanical transducer configured to convert an electrical signal into a mechanical vibration. The helmet according to claim 1, wherein the emitter device comprises an electropneumatic transducer configured to convert an electrical signal into a pneumatic signal. 4. The helmet according to claim 1, wherein at least one of the emitter device and the microphone or each of them is rigidly connected to at least one inner wall or one outer wall of the container body. 5. The helmet according to claim 1, wherein one of the emitter device and the microphone or each of them is arranged inside the internal volume, preferably worn on the patient's head 6. The helmet according to claim 1, wherein the communication system comprises a connector connected to the emitter device and to the microphone, wherein the connector ? arranged externally to the internal volume. 7. The helmet according to claim 1, wherein the communication system comprises an interface device able to be connected, preferably in a removable way, to the emitter device and/or to the microphone. 8. The helmet according to the preceding claim, wherein the interface device comprises an intercom system equipped with: - an external microphone configured to receive a sound from outside the internal volume and transmit it to the emitter device; and/or - an external emitter device configured to receive a signal from the microphone representative of the sound emitted by the patient and convert this signal into a sound emitted outside the internal volume. The helmet according to claim 7, wherein the interface device comprises a telecommunication device. 10. The helmet according to claim 7, wherein the interface device is integrated in a breathing gas and/or exhaled gas control device connected to the inlet connection and/or outflow connection.