WO2024160695A1 - Device for characterising the inspiratory and expiratory phases of the respiratory function of an individual, and facial administrator for a patient comprising such a device - Google Patents

Abstract

The invention relates to a device for characterising the inspiratory and expiratory phases of the respiratory function of an individual, comprising: - a mouthpiece (11, 12) positioned at a respiratory tract; - an outer part connected to the mouthpiece, and wherein: - the mouthpiece incorporates a reflectance optical pulse oximeter (30) which measures the SpO₂ of the individual at a lip of the individual; - the mouthpiece or the outer part incorporates a pressure sensor which measures the pressures of gas inspired by the individual during inspiratory phases and the pressures of gas expired during expiratory phases; - the mouthpiece or the outer part incorporates a processing unit (24) that calculates all or some of the following characteristics of the respiratory function of the individual and/or the variation in these characteristics on the basis of the inspiratory and expiratory phases: SpO₂, heart rate, respiratory rate, inspiratory and expiratory pressures.

Description

Description

Title: Device for characterizing the inspiratory and expiratory phases of the respiratory function of an individual and facial administrator for a patient comprising such a device

[Technical area.

[1] The invention relates to a device for characterizing the inspiratory and expiratory phases of the respiratory function of an individual. It also relates to a facial administrator for a patient comprising such a device. The individual and/or the patient may be human or animal, preferably human. This device and this facial administrator are available in two modes, one consisting of a nasal device/administrator and the other consisting of an orofacial device/administrator.

[2] This invention relates to the technical field of non-invasive measuring devices for examining the respiratory organs and blood characteristics of an individual. The invention makes it possible in particular to establish a diagnosis of the condition of an individual thanks to a plurality of biometric and biological readings and measurements, said readings and said measurements being made possible and available for a doctor, emergency doctor or the like thanks in particular to to the specific ergonomics of the device.

[3] The invention also relates to the technical field of devices for acting on the respiratory system of a patient, in particular intended to primarily offer assistance for therapeutic treatment by oral or nasal route of an unconscious or largely difficulty so that the latter is not able to apply such treatment himself or to help an external worker, such as a doctor or emergency doctor, to carry out this therapeutic administration by mouth or nasal route.

State of the art.

[4] When a patient is in a state of unconsciousness or semi-consciousness, first aid - the speed and efficiency of its administration - is decisive, first of all to provide the assistance necessary to maintain of the patient's vital functions, to their stabilization or even improvement, then to direct the patient to the appropriate medical service. [5] Given the patient's condition, the latter is often unable to express themselves correctly to inform the rescuers, but also to provide the slightest physical effort intended to help the rescuers, in particular to physically participate in the administration of its therapeutic treatment.

[6] These first aiders must therefore manage a situation urgently, without information given by the patient and without their help, including physical help, to administer, if necessary, the first treatments likely to save their life.

[7] In any case, it is generally useful to be able to characterize the inspiratory and expiratory phases of an individual's respiratory function before deciding to administer a possible therapeutic treatment.

[8] We currently know the document US 20070027375. This document describes a system allowing the detection, measurement and continuous monitoring of biometric parameters by the intraoral route in men (the term “man” is used here and in the remainder of this request to mean a human, regardless of gender and age). Such a system includes a mouth-facial tip, a biometric parameter detection module, a biometric data processing module and a biometric parameter display module. The mouth-facial tip is the type used for scuba diving.

[9] In addition to the fact that respiratory function is poorly characterized, taking biometric measurements or readings is unreliable, particularly due to inappropriate placement of sensors and other detection devices. In particular, the measurement of capillary oxygen saturation (SpÛ2) is carried out by transduction, by pinching the lip. Such pinching results in ischemia of the lip leading to a reduction in capillary circulation. As a result, SpÛ2 measurements are imprecise and lack reliability and reproducibility. This risk of ischemia can be increased intrinsically by the reduction in capillary circulation when the individual is in shock.

[10] The system described in US 20070027375 also does not allow the administration of therapeutic treatment to the patient.

[11] Document US 20130116512 is also known from the state of the art. This document describes a system allowing the detection, measurement and continuous monitoring of biometric parameters intraorally in humans. Such a system includes a mouth-facial tip, a biometric parameter detection module, a biometric data processing module, and a biometric parameter display module. The mouth-facial tip is the type used for scuba diving.

[12] Once again, taking measurements or biometric readings from the patient is unreliable, particularly due to inappropriate placement of sensors and other detection devices. The measurement of SpCL is here carried out at the level of the oral tissue of the individual, in particular the gum. This area is, however, too poorly vascularized for SpÛ2 measurements to reliably reflect the real and instantaneous respiratory and circulatory state of the individual. Also, it is impossible with this system to effectively administer a specific therapy.

[13] Furthermore, the devices known from the prior art are designed to be used in standard medical contexts but are not suitable for use in degraded intervention environments such as road accident zones, rail or air, sites of natural disasters such as floods, earthquakes, and storms, areas at risk of explosion, contamination by dangerous chemicals, or fires, as well as tunnels, underground, and other disaster areas with limited access and/or insufficient or non-existent network coverage and/or difficult intervention conditions (reduced visibility, darkness, etc.). These chaotic or urgent scenarios, in hostile or unpredictable environments, require speed and ease of use, particularly when numerous victims must be rescued, which prior art devices do not allow.

[14] The plaintiff thus intends to remedy all or part of the aforementioned drawbacks.

[15] Also, an objective of the invention is to propose a device making it possible to improve the characterization of the inspiratory and expiratory phases of the respiratory function of an individual. The device according to the invention offers the possibility of reliable and complete biometric and biological readings/measurements, particularly in degraded intervention environments.

[16] Another objective of the invention is to obtain instantaneous measurements having improved precision, reliability and reproducibility in comparison with the aforementioned prior art devices. [17] Yet another objective of the invention lies in the adapted ergonomics of the device, its compactness and its maneuverability.

[18] A further objective of the invention is to provide a device which is suitable for use in degraded intervention environments and which can be quickly and easily set up in such environments.

[19] A subsidiary objective of the invention is, based on this characterization of the inspiratory and expiratory phases of the respiratory function, to be able to apply, where appropriate, very effectively by oral or nasal route a specific therapy to a patient, without any specific action necessary both on the part of the patient and on the part of the first aider(s). The rescuer(s) can then concentrate on other essential tasks, for example extrication and transport of the patient.

[20] Another subsidiary objective of the present invention is to offer a facial administrator that is simple and quick to implement, that is to say that from its handling to therapeutic administration it flows a very short period of time.

[21] Yet another subsidiary objective of the present invention lies in the improved display of readings/measurements so as to establish in situ a medical condition of the patient.

[22] Yet another subsidiary objective of the invention lies in the automated management of both the diagnosis of an individual and their treatment adapted to said diagnosis.

Presentation of the invention.

[23] The invention relates to a device for characterizing the inspiratory and expiratory phases of the respiratory function of an individual, the device comprising:

- a tip intended to be positioned at least partially at the level of a respiratory tract, having a proximal portion having a central recess intended to be positioned in the mouth of the individual or in front of the orifices of the nose of the individual ,

- an external part intended to be positioned outside the body of the individual, connected to the tip, preferably fixed rigidly to it, having at least one main opening communicating with the central recess of the tip.

[24] And in which:

- the tip integrates an optical reflectance pulse oximeter configured to measure the capillary oxygen saturation of the individual, which oximeter is arranged to, in use, be positioned against a lip of the individual, which oximeter comprises at least one light source and at least one light detector arranged on the same side of said lip to measure the SpCL by reflectance,

- the tip or the external part integrates a pressure sensor arranged so as to measure the gas pressures inspired by the individual during the inspiratory phases and the gas pressures exhaled by the individual during the expiratory phases,

- the tip or the external part integrates a unit for processing data from the pulse oximeter and the pressure sensor, which unit is configured to calculate, in real time and from said data, all or part of the following characteristics of the individual's respiratory function and/or the variation of said characteristics as a function of the inspiratory and expiratory phases: SpCL, heart rate, respiratory rate, inspiratory and expiratory pressures,

- the processing unit comprises a memory area in which threshold values of the measured characteristics of respiratory function and/or threshold values of clinical indicators depending on said characteristics are recorded or calculated,

- the processing unit is configured to trigger a visual and/or audible alarm arranged on the external part when said unit detects the crossing of one or more of the threshold values,

- a display module is installed visibly on the external part, which module displays: the characteristics of the individual's respiratory function calculated by the treatment unit and the threshold values.

[25] The measurement and monitoring of respiratory and cardiovascular parameters represent a constant concern for health professionals (doctors, first aiders, ambulance drivers, firefighters) and/or in the sports field. Among these parameters, SpCL, heart rate (HR), respiratory rate (RR), inspiratory and expiratory pressures, as well as their variations according to the inspiratory and expiratory phases, are determining elements in order to diagnose and/or assess the severity of clinical situations. Having the device according to the invention for the acquisition and monitoring (which we will call monitoring) of these parameters is therefore very interesting, and even essential. [26] The user now has a single device, which is compact, very easy to install, and allows the acquisition and monitoring of multiple respiratory and cardiovascular parameters.

[27] Due to the original configuration of the device, it is now possible to measure SpÛ2 under optimized conditions. Indeed, due to the arrangement of the optical pulse oximeter and its reflectance detection mode, capillary circulation in the lip is preserved from any risk of ischemia, whether resulting from pathologies specific to the lip. individual (e.g. state of shock), or whether it results from the use of transduction measurement techniques which require pinching or constraint of the measurement area.

[28] Also, by combining the data from the pulse oximeter and the pressure sensor, the device makes it possible to calculate, in addition to the SpCL, the heart rate, the respiratory rate and the inspiratory and expiratory pressures, as well as their variations in function of the inspiratory and expiratory phases. As a result, the inspiratory and expiratory phases of respiratory function are very well characterized.

[29] The ability of the device to jointly and reliably measure respiratory parameters such as respiratory rate and SpCL concomitantly with heart rate is of fundamental importance in medicine. Indeed, a significant number of cardiac arrests result from hypoxemia (oxygenation deficit), hypoxemia which could be detected to prevent the occurrence of a fatal outcome. This capacity is also interesting in a sporting environment since the conditions for physical adaptation to an effort, whatever their nature, are a function of cardiopulmonary interaction.

[30] The processing unit, equipped with a memory area, makes it possible to record or calculate critical threshold values for various respiratory characteristics and clinical indicators. This storage and processing capability ensures that the device can operate autonomously and accurately even in the most extreme conditions of degraded intervention environments, providing reliable analysis in real time. In chaotic emergency situations, where every second counts, this functionality allows response personnel to act quickly and confidently, based on accurate, up-to-date information. [31] The activation of visual and/or audible alarms as soon as values are detected helps personnel to immediately recognize critical situations, particularly in noisy or chaotic environments, even without direct consultation of the display module of the device. In these contexts where attention may be less and/or in cases of limited visibility, these alarms offer a quick and effective means of communication. This self-diagnosis and early warning capacity thus ensures the operationality of the device in degraded intervention areas or extreme conditions of use.

[32] The clearly visible display module plays a key role in presenting essential information in a readable and immediate manner. By displaying both respiratory characteristics and threshold values, it allows rapid interpretation of data by staff, essential in emergency scenarios where the speed of intervention can be decisive for the outcome. The visibility and clarity of the display are particularly beneficial, especially in low light or smoke conditions.

[33] These different characteristics make the device which is the subject of the invention perfectly suited for use in emergency or degraded intervention conditions. The combination of these features ensures that the device not only remains functional, but also a reliable tool for diagnosis and rapid decision-making in the most demanding situations.

[34] All measurements are collected by the single device, as close as possible to the respiratory tract, so that they are particularly precise, reliable and reproducible. The device thus makes it possible to characterize the real and instantaneous respiratory and circulatory state of the individual. Since the respiratory function is characterized completely and precisely, an administrator integrating this device makes it possible to administer or not an appropriate therapy at the right time.

[35] The invention therefore allows “controlled” therapy in the sense that the precise characterization of the inspiratory and expiratory phases of the respiratory function can indicate therapy or not, but also can best define the therapy indicated as well as the monitoring of its effectiveness (or its failure and therefore the need for modification). [36] Thus, the invention also relates to a facial administrator comprising the aforementioned device, and in which the external part comprises a drug administration module of a medicinal composition in fluid form or in powder form, said module d administration comprising administration means allowing administration of the medicinal composition through the main opening during the inspiratory phases.

[37] Thanks to this administrator, emergency intervention to treat a patient is carried out efficiently within a minimum time.

[38] As presented previously, the facial administrator is capable of being applied to the mouth, in its version of an orofacial administrator, or to the nose, in its version of a nasal administrator, of a patient . In the following, the present invention is essentially presented in connection with an oro-facial administrator, but excluding the elements specific to the temporary attachment of the administrator to the two facial orifices - mouth and nose - these oro-facial and nasal administrators present and have the same characteristics.

[39] Other advantageous features of the apparatus that is the subject of the invention are listed below. Each of these features can be considered alone or in combination with the remarkable features defined above. Each of these features contributes, where appropriate, to the resolution of specific technical problems defined further in the description and in which the remarkable features defined above do not necessarily participate. The latter may be the subject, where appropriate, of one or more divisional patent applications:

[40] According to one embodiment, the display module is positioned on the front face of the external part, which front face is advantageously perpendicular or substantially perpendicular to a longitudinal axis of the end piece.

[41] According to one embodiment, the device further comprises at least one module for administering an agent for modulating the tissue perfusion of the oral mucous membranes of the individual, said module being configured to administer said agent at the level of the proximal portion of the tip. [42] According to one embodiment, the modulation agent administration module is controlled by the processing unit so as to automatically administer said agent when said unit detects the crossing of one or more of the threshold values.

[43] According to another embodiment, the modulation agent administration module is controlled manually, via a push button or the like placed on the external part.

[44] According to one embodiment, the module for administering the modulating agent comprises a means for aerosolizing said agent, so that said agent is administered in the form of an aerosol in the central recess.

[45] According to one embodiment, the module for administering the modulating agent comprises or is in the form of a patch containing said agent, which patch is arranged to, in use, be positioned against the lip of the individual, at least at the level of the oximeter.

[46] According to another embodiment, the tissue perfusion modulating agent comprises a vasodilator, a hydrating agent, or a combination thereof.

[47] According to one embodiment of the device, the tip or the external part integrates a gas analyzer adapted to measure the fraction of at least one gaseous component inspired and/or exhaled by the individual, the unit of treatment being configured to calculate, on each respiratory cycle, the Inspired Fraction of said gas component and the Exhaled Fraction of said gas component.

[48] According to one embodiment: the gas analyzer includes an oxygen sensor making it possible to measure the Inspired Fraction of Oxygen and the Exhaled Fraction of Oxygen (FeO2); the processing unit is configured to calculate a Hypoxemic Index severity score defined by the ratio (SpO2/FR) and/or an ROX severity score defined by the ratio [(SpO2/FiO2)/FR]; threshold values of the Hypoxemic Index severity score and/or the ROX severity score are recorded or calculated in the memory area of the processing unit; the display module also displays the threshold values of the Hypoxemic Index severity score and/or the ROX severity score.

[49] According to one embodiment of the device, the tip is of the oro-facial type, said tip consisting of a diving snorkel tip or a mouthpiece for a diving regulator, the proximal portion being intended to be positioned in the mouth of the individual abuts against his jaw or his teeth, the distal portion forming a protuberance extending between the lower and upper teeth of the individual.

[50] According to one embodiment of the device, the tip is of the nasal type, said tip consists of a mask intended to cover or cover the two nasal orifices of the individual, preferably said mask being held against said two orifices thanks to to a strap or lanyard whose two ends are fixed to said mask.

[51] According to one embodiment of the device, the tip or the external part integrates a spirometer to measure the inspiratory and expiratory flow rates.

[52] According to one embodiment of the device, the mouthpiece or the external part comprises an expiratory brake.

[53] According to one embodiment of the administrator, the processing unit comprises a memory area in which threshold values of the measured characteristics of respiratory function and/or threshold values of clinical indicators functions of said functions are recorded or calculated. characteristics, the means for administering the medicinal composition being automatically controlled by said processing unit when at least one of said threshold values is crossed.

[54] According to one embodiment of the administrator, the means of administering the medicinal composition are controlled manually, via a push button or the like placed on the external part.

[55] According to one embodiment of the administrator, the means of administration comprise means of aerosolizing the medicinal composition, so that said composition is administered in aerosol form.

[56] According to one embodiment of the administrator, the tip or the external part comprises a particle filter configured to recover particles during the patient's expiratory phases, advantageously said particle filter further consisting of an antibacterial filter and /or antiviral, the processing unit and/or said filter being configured to analyze said recovered particles.

[57] According to an embodiment of the administrator

- the external part comprises a conduit for a gas mixture having an outlet orifice communicating with the central recess of the nozzle and an inlet orifice present on the external part, advantageously said inlet orifice being intended to connect to an external conduit for the administration to the patient of a so-called therapeutic gas mixture,

- the processing unit comprises a memory zone in which threshold values of the measured characteristics of the respiratory function and/or threshold values of function indicators of said characteristics are recorded or calculated,

- the composition and/or flow rate of the gas mixture being automatically adjusted by the processing unit, during the inspiratory and expiratory phases, when at least one of said threshold values is crossed.

[58] According to one embodiment of the administrator, the external part comprises a regulator for managing the pressure of the gas mixture passing in or via the above-mentioned conduit for the gas mixture, the pressure of said gas mixture being adjusted automatically by said unit treatment, at a determined pressure value, when at least one of the threshold values is crossed.

[59] According to one embodiment of the administrator, the expiratory brake is configured to have an adjustable resistance, which resistance is automatically adjusted by said processing unit, to a determined resistance value, when at least one of the threshold values is crossed.

Brief description of the figures.

[60] Other advantages and characteristics of the invention will appear better on reading the description of a preferred embodiment which follows, with reference to the appended drawings, produced as indicative and non-limiting examples and on which :

[Fig. 1] is a general front view, slightly to the side, of a mode of execution of an orofacial device/administrator according to the invention.

[Fig. 2] is a general view from the rear, slightly sideways, of the embodiment of the orofacial device/administrator visible in Figure 1.

[Fig. 3] is a general top view of the orofacial device/administrator shown in Figures 1 and 2.

[Fig. 4] is a schematic sectional view of the device/orofacial administrator visible in Figures 1 to 3. [Fig. 5] is a sectional view along a vertical plane of the orofacial device/administrator visible in Figures 1 to 3.

[Fig. 6] is another schematic sectional view of the device/administrator visible in Figures 1 to 3.

[Fig. 7] is a top view of the orofacial device/administrator shown in Figures 1 to 3.

[Fig. 8] is a schematic view of a nasal device/administrator applied to a patient's head.

[Fig. 9] is a schematic sectional view of an embodiment of the nasal device/administrator presented in Figure 8, on which we see in particular the upper labial biometric sensor and its positioning relative to the patient's mouth.

[Fig. 10] is also a schematic profile view of the nasal device/administrator presented in Figures 8 and 9, on which the presence of the labial biometric sensor is highlighted.

Description of the embodiments.

[61] The attached Figures 1 to 7 present a mode of execution of a facial device/administrator 1 consisting here of an orofacial device/administrator.

[62] The device according to the invention is essentially used for monitoring. It is preferentially used in a medical setting to diagnose, control and/or monitor the condition of a patient. However, it can be used in a non-medical context, to monitor a healthy individual, for example in a sporting context to monitor the performance of an athlete. In other words, the device is configured to characterize the inspiratory and expiratory phases of an individual, and is sufficient to resolve the aforementioned technical problems of characterizing respiratory function and precision and/or reliability and/or reproducibility of the measurements. .

[63] The administrator differs from the system in that he is able to manage the administration of therapy in addition to monitoring. The ability to administer this therapy is an additional option of the device.

Monitoring [64] The oro-facial device 1 has a plurality of functions, but it is clearly understood here that it includes in its essential version an oro-facial tip 10 intended to be positioned at least partially at the level of the mouth of the individual/patient, an external part 20 intended to be positioned outside the body of the individual/patient, connected to the orofacial tip 10, a pulse oximeter 30, a pressure sensor 27 and a unit treatment 24.

[65] The device also preferably comprises one or more batteries making it possible to power its various on-board components and ensure autonomous operation. According to a preferred embodiment, one or more removable and/or interchangeable and/or rechargeable batteries are installed in the external part 20, for example Lithium-ion batteries.

[66] In this exemplary embodiment, the oro-facial device 1 comprises a first part consisting of an oro-facial tip 10 which itself comprises a proximal portion 11, a distal portion 12 and a recess (or conduit, both terms being equivalent to the meaning of the invention) central 13, this recess 13 forming a section for routing the inspired/exhaled gases and allowing, where appropriate, the administration of agents for modulating tissue perfusion, drug administration as well as possibly a gas mixture such as super-oxygenated air passing through or coming from the external part 20. Thus the orofacial device 1 further comprises a second part 20 integral with the above-mentioned first part 10 consisting of an external part 20 which has a main opening 21 in fluid communication with the central recess 13 of the orofacial tip 10.

[67] The oro-facial device 1 thus comprises two distinct parts connected to each other, namely the tip 10 and the external part 20. According to an advantageous embodiment, the oro-facial tip 10 is removable from the external part 20 and the latter allows the adaptation and fixing of different shapes and sizes of oral-facial tips 10 specific to the invention. Once assembled, the mouth-facial tip 10 and the external part 20 form a particularly compact one-piece assembly. In the appended figures, the junction between the end piece 10 and the external part 20 is in the form of a tubular conduit 120 of cylindrical or substantially cylindrical external shape, the length of which varies for example from 1 cm to 5 cm. [68] In the orofacial version of the tip 10, the proximal portion 11 is intended to be positioned in the mouth of the individual/patient abutting against his jaw or his teeth. The distal portion 12 forms a protuberance, or bite zone, extending between the lower and upper teeth of the individual/patient. The proximal portion 11 has a lip rim 110 configured to, in use, be positioned in the mouth of the individual between his teeth and the interior part of his lips. Lip rim 110 forms a seal when in the individual's mouth.

[69] The dimensions of the tip 10 are those currently found for mouthpieces of the diving snorkel type or mouthpiece for a diving regulator, with one or more child sizes, depending on of the child's age, then typically two or three adult sizes depending on the adult's body shape. The dimensions of the tip 10, that is to say essentially of its proximal portion 11, are classic and do not differ from what can currently be found on the market. Note, however, that the device 1 can be used for young children, which is obviously not envisaged for diving, so that the tip 10 can have small sizes suitable for young children or even children. infants.

[70] Such a tip 10, thanks to its proximal 11 and distal 12 portions, allows easy positioning and maintenance in position in contact with the oral sphere, without the help of the individual/patient, in particular so as to perform reliable and reproducible measurements and, where appropriate, correctly administer a tissue perfusion modulating agent or a medicinal composition.

[71] As presented previously, the oro-facial tip 10 can be of different shape and/or material depending on the anatomical and physical conditions, said tip 10 having to ensure the freedom of passage of air in the central recess 13 so as not to hinder the breathing of the individual/patient. The oro-facial tip 10 can be cylindrical, rectangular or truncated cone shaped. The end piece 10 can be made of plastic, metallic material or alloy. The material used is preferably resistant to shocks, high temperatures and chemical substances so that the device can operate reliably in degraded intervention areas or extreme conditions of use. The materials preferably used are polycarbonate, High Density Polyethylene (HDPE), thermoplastic elastomers (TPE), Teflon® (PTFE), stainless steel, titanium, or a combination of these materials. [72] The tip 10 comprises a section for routing the inspired/exhaled gases and a biting device (tongue, tooth molding) at the level of the distal part 12. In a preferred embodiment, the tip 10 comprises, at its proximal portion 11, a flexible lower part allowing movements of the lower lip so that the subject is capable of emitting sounds.

[73] The external part 20 can be in a general cylindrical, ovoid or spherical shape and is for example part of a sphere having a diameter of at most twenty centimeters, advantageously at most ten centimeters. Thus, the external part 20 is easily graspable by a human hand so as to be able to place the orofacial tip 10 in the patient's mouth. Of course, the external part 20 can have several sizes depending on the different modules that it houses, the biometric and biological data that it can control and analyze, the display module 25 and, as explained further in the description, of the size and number of cartridges forming the administration module 29. The external part 20 can be made of plastic, metallic material or alloy, the materials preferably used being those mentioned above.

[74] The size and configuration of the orofacial device 1, more specifically the arrangement of the mouthpiece 10 and the external part 20, preferably correspond to those of a conventional diving regulator with integrated mouthpiece of the market, so that said device is particularly compact, ergonomic and comfortable in the mouth.

[75] The external part 20 advantageously comprises one or more display modules 25 advantageously located on the face opposite the mouth-facial tip 10. This display module 25. The display module 25 is installed in a visible manner on the external part 20.

[76] According to a preferred embodiment, the display module 25 is located on the distal part of the external part 20, more particularly positioned on the front face of said external part. In the attached figures, this front face is perpendicular or substantially perpendicular to the longitudinal axis of the tip 10. The display module 25 is thus positioned perpendicular or substantially perpendicular to the longitudinal axis of the tip 10. This arrangement ensures optimal visibility of the display module 25 for the operator who intervenes (caregiver, doctor, rescuer, firefighter, etc.) particularly in contexts where the individual/patient is in a lying position. Unlike devices where the screen is located on the side, this arrangement allows the operator to easily read the information displayed without needing to reposition the device or move around. In other words, the display module 25 is oriented and designed to provide a clear and direct viewing angle to the operator, facilitating monitoring of individual data and alerts. This feature is particularly advantageous in emergency situations, where rapid and accurate monitoring is crucial for the care of the individual.

[77] The display module 25 displays all or part of the calculated characteristics of the respiratory function of the individual as well as threshold values of these characteristics and/or threshold values of clinical indicators functions of said characteristics, so that these information is presented in a readable and immediate manner. By displaying both respiratory characteristics and threshold values, the display module 25 allows rapid interpretation of the data, which is particularly advantageous in emergency scenarios where the speed of intervention can be decisive for the outcome.

[78] In a preferred embodiment, the display module 25 comprises a display screen located on the surface of the external part 20 and allowing the reading of data in degraded conditions, that is to say in an environment with reduced visibility (fire smoke, nighttime conditions, transport in a confined space such as a helicopter). For reliable operation of the device in degraded intervention areas or extreme conditions of use, the display module 25 advantageously takes the form of a liquid crystal screen (LCD) or an organic screen with light-emitting diodes (OLEDs) provide excellent readability under various lighting conditions, and feature good brightness and high contrast to ensure clear visibility even in bright sunlight or dark environments. An anti-reflective coating is advantageously provided to maintain the readability of the screen 25 even under intense or direct light. According to one embodiment, the screen 25 is associated with an adjustable backlight allowing its brightness to be adapted to environmental conditions, saving battery while guaranteeing visibility. The screen 25 is preferably protected by an impact-resistant material, such as tempered glass or a reinforced polymer, to avoid damage in the event of a fall or impact. The screen 25 can be sealed encapsulated to protect it against water, dust, and chemical contaminants. [79] In general, all the biometric and/or biological measurements or readings can be displayed on the display module 25 or even only some of these measurements or readings, the other measurements and readings being capable of integrating an overall calculation reflecting the state of health of the individual/patient and, where applicable, their degree of medical/therapeutic emergency.

[80] According to one embodiment, at least the inspiratory and expiratory phases of the individual/patient are displayed, but other parameters or data coming from the module for collecting biometric and biological parameters of the individual/patient which can be displayed. This display of the respiratory phases can be done by any means, for example by a green visual signal when the inspiratory phase of the individual/patient takes place.

[81] •

[82] According to one embodiment, the tip 10, and advantageously the recess 13, is advantageously subdivided so as to distinctly present an inspiratory channel and an expiratory channel for the air exhaled by the individual/patient. The inspiratory channel allows the individual/patient to inhale ambient air or the gas mixture described further in the description. This inspiratory channel advantageously has a non-return valve or unidirectional valve, for example a flexible valve, preventing the air exhaled by the individual/patient from entering said inspiratory channel. The exhaled air passing through the expiratory channel is then evacuated into the ambient air, after passing through the different elements of the module for collecting biometric and biological parameters.

[83] According to another embodiment, the inspiratory channel and the expiratory air channel have a common section, consisting in particular of the recess 13 and an internal chamber of the external part 20. The entrance to the inspiratory channel can then consist of the inlet orifice 41 arranged on a wall of the external part 20, the outlet of said inspiratory channel being the opening of the recess 13 located at the level of the distal portion 12 and opening at the level of the channel respiratory of the individual/patient. This opening of the recess 13 also forms the entrance to the expiratory channel, the outlet of said expiratory channel consisting of an outlet orifice 31 arranged on a wall of the external part 20.

[84] The biometric and biological parameter collection module defines all the elements - physical or functional - likely to collect continuously or timely data on the state of health of the individual/patient and, where applicable, data on the nature of the gas inspired and expired by said individual/patient. In the non-exhaustive example chosen to illustrate the invention, the collection module of the device 1 thus comprises in particular a reflectance pulse oximeter 30 located on the proximal part 11 of the oro-facial tip 10 so as to take measurements. measurements, without pinching or other mechanical actions likely to cause ischemia, at the lip of the individual/patient.

[85] The oximeter 30 is configured to measure punctually, or preferably continuously, the capillary oxygen saturation (SpCL) of the individual/patient. Pulse oximetry, also called pulsed capillary oxygen saturation (SpCL), is a non-invasive test to assess the oxygen saturation of hemoglobin in blood capillaries. The measurement principle (oximetry) is based on the combination of a light source, a light detector and a microcontroller. The light source generally emits in two wavelengths, one in the red, the other in the infrared. Oxyhemoglobin absorbs little red light, but does not allow infrared rays to pass through. Deoxyhemoglobin absorbs little infrared and does not allow red light to pass through. To know the CHbCL and CHb concentrations, it is sufficient to send two light rays of different wavelengths through the skin and analyze the resulting light (principle of absorbance). The two biometric variables measured by the oximeter are SpCL and heart rate (HR).

[86] The oximeter 30 is arranged to, in use, be positioned against a lip of the individual/patient, advantageously at the level of the upper lip. It is preferably installed on the lip rim 110 or on the external surface of the conduit 120. Referring to Figure 3, the oximeter 30 comprises at least one LED 301 (the light source) and at least one photodetector 302 (the light detector) arranged on the same side of said lip to measure the SpCL by reflectance. Since the lip is not pinched by the oximeter 30, the capillary circulation of the measurement site is preserved from any risk of ischemia. Furthermore, as the lip is a richly vascularized area, SpCL measurements reliably reflect the actual and instantaneous respiratory and circulatory status of the individual/patient. In use, the LED 301 and the photodetector 302 can be arranged at the internal or external face of the lip. Due to its conformation, the tip 10 makes it possible to maintain the oximeter 30 in adequate anatomical conditions to carry out the measurements, said oximeter being correctly maintained in contact with the internal or external face of the lip.

[87] The tip 10 or the external part 20 advantageously integrates a pressure sensor 27 arranged so as to measure the gas pressures inspired by the individual/patient during the inspiratory phases and the gas pressures exhaled by the individual/patient. patient during the expiratory phases. This pressure sensor 27 is advantageously installed in the central conduit 13 so as to measure the pressures as close as possible to the respiratory tract of the individual/patient, which measurements are then particularly precise, reliable and reproducible.

[88] A unit 24, integrated in the tip 10 or in the external part 20, is configured to process (in particular: receive, transform, store, transmit) the data coming from the oximeter 30 and the pressure sensor 27, and to calculate, in real time and from said data, the following characteristics of the respiratory function of the individual/patient and/or the variations of these characteristics during the inspiratory and expiratory phases: the SpCL, the heart rate HR, the FR respiratory rate, inspiratory and expiratory pressures. According to one embodiment, the unit 24 can calculate only part of these characteristics, for example only the respiratory frequency FR and the inspiratory and expiratory pressures.

[89] Heart rate HR speeds up during inspiration and slows down during expiration because the autonomic nervous system is sensitive to breathing. The device thus makes it possible to better appreciate the consequences of the inspiratory and expiratory phases of breathing on cardiac function.

[90] The respiratory frequency FR can in particular be obtained by averaging over time the pressure peaks generated by inspiration or the depression peaks generated by expiration.

[91] In addition, the pressure measurements allow the unit 24 to calculate, on each respiratory cycle, the time of the respiratory cycle allocated to inspiration and that allocated to expiration. The unit 24 can then define an Inspiration/Expiration (I/E) ratio, to easily assess respiratory pathologies such as asthma and/or chronic obstructive bronchopathy in which the I/E ratio is a marker of the stability of the disease, the deterioration of the patient and the effectiveness of the therapies administered. This I/E ratio can also be used in a sporting context to assess an individual's capacity for recovery and/or their ability to withstand an effort.

[92] In addition, the integration over time of pressure measurements, and under known conditions of inspiratory and expiratory pressures, makes it possible to define the inspiratory and expiratory flow rates. The inspiratory flow rate reflects the inspiratory muscular capacity of the individual/patient and therefore their respiratory function. The expiratory flow rate reflects the quality of the bronchi of the individual/patient. These measurements thus make it possible to participate in the characterization of respiratory function at a given time, and therefore to indicate or not the need for therapeutic treatment, but also to assess the effectiveness of the therapies administered. This characterization can also be analyzed in a sporting context to assess an individual's capacity for recovery and/or their ability to withstand an effort.

[93] The processing unit 24 may consist of a processor, microprocessors, CPU (for Central Processing Unit), controller, microcontroller, etc. This module makes it possible to process the data by digital conversion, averaging, filtering. It can also provide a transformation, a combination of the data in order to provide clinical scores. It can also store the data and transmit it. This transmission can be done either to the display module 25 or to a third-party receiver by wired or wireless transmission (wifi, Bluetooth). This transmission can be done punctually or continuously, the continuous transmission of parametric data advantageously defining the notion of monitoring.

[94] According to one embodiment, the tip 10 or the external part 20 integrates a gas analyzer 28 adapted to measure the fraction of at least one gaseous component inspired and/or exhaled by the individual/patient. This analyzer 28 is advantageously installed in the central conduit 13 so as to carry out measurements as close as possible to the respiratory tract of the individual/patient, which measurements are then particularly precise, reliable and reproducible. The unit of 24 is thus advantageously configured to calculate, on each respiratory cycle, the Inspired Fraction of said gas component and the Exhaled Fraction of said gas component. For example, the analyzer 28 may include an oxygen sensor allowing measurement of the Inspired Fraction of Oxygen (FiÛ2) and the Exhaled Fraction of Oxygen (FeÛ2). The analyzer 28 may also include a carbon dioxide sensor allowing measurement of the Inspired Fraction of carbon dioxide. (FiCCh) and the Fraction Exhaled carbon dioxide (FeCCL). Other types of gaseous components can be analyzed, in particular toxic gases released during fires (cyanides, hydrogen sulphide and carbon oxides, chlorine, etc.) and likely to have been inhaled by the individual/patient, or even the alcohol concentration in the respiratory tract, the analyzer 28 then having a function as an ethylometer.

[95] All of the sensors 30, 27, 28 constitute the module for collecting biometric and biological parameters which can of course include other elements/sensors likely to be considered to determine the state of the individual/patient (for example a body temperature sensor, an analyzer of sounds emitted by the individual/patient).

[96] According to an advantageous embodiment, thanks to the simultaneous acquisition of the various aforementioned data, the processing unit 24 can also be configured to calculate one or more clinical indicators of the measured characteristics of the respiratory function, and in particular the Hypoxemic Index severity score defined by the ratio (SpCL/FR) and/or the ROX severity score defined by the ratio [(SpCh/FiChyFR], The inventor was able to note that the analysis of variations in the Index severity score Hypoxemic were particularly relevant in predicting the need for orotracheal intubation and artificial ventilation when caring for patients in respiratory distress. The inventor also found that the analysis of variations in the ROX severity score were particularly relevant. to the vital prognosis (survival of patients) during acute respiratory failure requiring oxygen therapy None of the aforementioned prior art devices is capable of calculating and analyzing this type of clinical indicators in situ. These indicators are also useful in a sporting context to assess an individual's capacity for recovery and/or their ability to withstand an effort. These indicators can be calculated continuously, for example every two seconds, or occasionally.

[97] The simultaneous acquisition of the various aforementioned data also allows unit 24 to determine additional monitoring parameters which have demonstrated their importance in the management of patients in respiratory distress. Thus, the calculation of the “New Early Warning Score” (“NEWS”) was able to demonstrate its predictive and prognostic interest in intra-hospital medicine. The NEWS score is based in particular on the occasional (non-continuous) collection of respiratory parameters (SpCL, HR, FR) and makes it possible to predict clinical deterioration in a patient. [98] According to one embodiment, the tip 10 or the external part 20 integrates a spirometer to measure the inspiratory and expiratory flow rates. Although these flow rates can be deduced from the integration over time of the pressure measurements of the sensor 27, this spirometer provides a certain measurement redundancy and can in particular be used in the event of failure of said pressure sensor. It is the same for the measurement of respiratory frequency which can be deduced from the spirometer measurements from the ratio between the number of inspiratory/expiratory deliveries related to time. The spirometer is advantageously placed within the orofacial tip 10, in particular in the central recess 13, or in the external part 20.

[99] According to one embodiment, the device comprises one or more administration modules 29 of an agent for modulating the tissue perfusion of the oral mucous membranes of the individual, said module being configured to administer said agent at the level of the proximal portion 11 of the tip 10. Such administration ensures in particular targeted and optimal delivery of the modulating agent to the oral mucous membranes, promoting localized, rapid and effective absorption. The tip 10 and/or the external part 20 may include this administration module 29.

[100] By improving tissue perfusion, the modulating agent makes it possible to obtain reliable and precise measurements of the characteristics of respiratory function and/or makes it possible to improve and/or optimize the speed of these measurements. This is particularly advantageous for individuals in a state of shock or having poor peripheral circulation, and for whom the measurements of the oximeter 30 may not be reliable. This is particularly the case for individuals suffering from hypoxemia (low concentration of oxygen in the blood) or hypoperfusion (reduced blood flow), for individuals with hemodynamic instability, in situations of exposure to cold ( for example: interventions in mountains or in arctic regions) where peripheral vasoconstriction can distort oximetry measurements, in the case of vasoconstriction induced by a drug (in particular vasoconstrictors), for individuals in a state of severe dehydration which can lead to a reduction in blood volume and vasoconstriction, or for individuals suffering from skin conditions affecting the perfusion or oxygenation of the skin, as in certain vascular or dermatological diseases. In such situations, administration of a modulating agent may help stabilize and/or improve tissue perfusion and/or maintain healthy circulation. sufficient device, so that the measurements of the oximeter 30 are much more reliable, precise and rapid.

[101] The tissue perfusion modulating agent preferably comprises a vasodilator, a moisturizing agent or a combination thereof. For example, the vasodilator is trinitrin, menthol or capsaicin. The moisturizing agent may be a humectant of glycerin, petrolatum, hyaluronic acid, synthetic lipids, etc.

[102] In the appended figures, the administration module 29 is arranged at the external part 20. It comprises for example one or more cartridges containing the modulation agent. This or these cartridges can be directly integrated into the external part 20. The external part 20 can also have one or more dedicated connectors, for example of the quick connector type, onto which the cartridges are connected.

[103] The administration module 29 advantageously comprises a means for aerosolizing the modulating agent (for example a vaporization or spraying means), so that said agent is administered in the form of an aerosol in the recess central 13, via the main opening 21, and in fact in the mouth of the individual. In doing so, the modulating agent is easily and quickly distributed evenly across the mucous membranes and assimilated more quickly by the individual. In a preferred embodiment, the aerosolization of the modulating agent is carried out by a piezoelectric vaporizer.

[104] According to one embodiment, the administration module 29 is controlled by the processing unit 24 so as to automatically administer the modulation agent when said unit detects the crossing of one or more of the threshold values. This automatic administration allows rapid and precise intervention in response to specific changes and/or inconsistencies in the measured data. This functionality thus ensures appropriate and timely administration of the modulation agent, improving the reliability of the measurements and/or reducing the risks associated with latency in these measurements. This administration is preferably carried out during the inspiratory phases.

[105] Alternatively or additionally, the administration module 29 can be controlled manually, via a push button or the like placed on the external part 20. This possibility of manually controlling the administration of the modulating agent offers flexibility of use. The operator can activate the administration based on the assessment of the situation, and/or depending on the state of the individual.

[106] According to one embodiment, the administration module is in the form of a patch 290 containing the modulation agent. This patch 290 can replace or complement the aforementioned module 29. The patch 29 is arranged so that in use, it is positioned against the lip of the individual, at least at the level of the oximeter 30. This arrangement ensures at least targeted administration at the measurement area of the oximeter 30. , thus increasing the precision of measurements thanks to improved tissue perfusion in this area. The patch 290 is preferably installed on the tip 10, in particular on the lip rim 110 and/or on the external surface of the conduit 120. The patch 290 is in the form of a transdermal patch, a soaked pad, or any other elements equivalent to progressive disintegration of the modulating agent.

Therapeutic administration

[107] In a medical context, the detection and monitoring (monitoring) capabilities of the device 1 make it possible to indicate (or not) an appropriate therapeutic administration and, where appropriate, to administer this therapy at the appropriate time. appropriate, and to adapt this administration according to monitoring (i.e. the evolution of the measured characteristics). The invention therefore makes it possible to monitor the effectiveness of this therapy (or its failure) and possibly modify it if necessary.

[108] When the device is capable of managing the administration of therapy in addition to monitoring, said device is considered in the context of the present invention as an “administrator”.

[109] The administrator according to the invention intends in particular to save lives thanks to its characteristics allowing the rapid, efficient and easy distribution, including for a single operator facing an unconscious patient, of a medicinal solution adapted to the emergency situation, and this in any condition, in particular extra-hospital. Nevertheless, this aspect of the invention is not limited to this sole application and can also be envisaged when the situation is not a life-threatening emergency and/or requires a more precise diagnosis for the administration of a medicinal dosage and/or very specific assistance. [110] In its administrator version, the external part 20 comprises a drug administration module 22 for a drug composition in fluid form or in powder form. The module 22 further comprises administration means enabling administration of the drug composition through the main opening 21 during the inspiratory phases. The processing unit 24 makes it possible in particular to determine the inspiratory phases and to automatically trigger a controlled administration of the drug composition during these phases. Alternatively or additionally, the means for administering the drug composition are controlled manually, via a push button or the like arranged on the external part 20.

[111] The expression “medicinal composition” means any type of medication capable of being administered as a first therapeutic treatment with a view in particular to regaining consciousness of the patient and/or maintaining functional function of the vital organs.

[112] By way of non-limiting examples, such a medicinal composition may for example consist of oxygen, oxygenated air, a gas mixture for therapeutic purposes (e.g. helium), a corticoid medication, an anticonvulsant, an antiarrhythmic, epinephrine, actilyse, suxamethonium, naloxone, ketamine, ipratropium bromide, morphine, adrenaline, valium, isoprenaline, diltiazem, norepinephrine, dopamine, a bronchodilator, anexate, benzodiazepines, a vaccine, or a combination of several of these medications.

[113] According to one embodiment, the administration module 22 comprises one or more cartridges of a medicinal composition. This or these cartridges can be directly integrated into the external part 20. The external part can also have one or more dedicated connectors, for example of the quick connector type, onto which the cartridges are connected. A medicinal cartridge comprises a single medicinal composition, this cartridge comprising a drug or a combination of drugs.

[114] Thus, according to one scenario, the operator has in his equipment a plurality of cartridges adapted to the facial administrator according to the invention, each of these cartridges responding to the urgency of a particular diagnostic situation likely to be established by the context and/or witnesses. Then, thanks to the readings and possibly the monitoring of the patient's parameters, another medicinal composition, in terms of dosage and/or therapeutic nature, can be administered.

[115] Thanks to these characteristics, a first aider, a doctor or any other person can easily and efficiently distribute a given quantity of a medicinal composition capable of stabilizing or even improving the health of a particular patient when the latter is in a state of unconsciousness or partial or total motor incapacity.

[116] This operator uses the cartridge or one of the cartridges of the administrator according to the invention if such a cartridge is already present in the administrator or this operator inserts a specific cartridge, for example corresponding to an overdose situation. heroin or crack, in the administrator if the cartridge(s) present in the administrator is not or are not likely to be used in the specific case.

[117] Thus, thanks to the administrator according to the invention, a single operator can act quickly and effectively in the face of an emergency or distress situation of a patient, whatever the conditions of intervention, in particular in an extra-hospital context.

[118] This operator must preferably have the minimum medical knowledge enabling him to determine, possibly approximately, the medicinal composition adapted to the emergency situation of the patient, identified by a context and/or witnesses. However, taking into account the ease of use, the pre-dosing of the medicinal composition and also the easy handling of the administrator, any person without particular medical skills (and in particular the patient himself) can possibly administer it himself. even this composition as long as each cartridge, with its medicinal composition, is visually identified - for example using color codes or a quick-read placard/notice - to respond to this or that specific emergency situation.

[119] According to an advantageous embodiment of the invention giving greater autonomy to the administrator 1, the processing unit 24 comprises a memory area in which threshold values of the measured characteristics of the respiratory function and/or threshold values of clinical indicators depending on said characteristics are recorded or calculated. These indicators are in particular those mentioned above. According to an advantageous embodiment of the invention realization, these threshold values are calculated by an artificial intelligence program executed by the unit 24. The processing unit 24 equipped with a memory area, thus makes it possible to record or calculate critical threshold values for various respiratory characteristics and clinical indicators. This memorization and processing capacity guarantees that the device can operate autonomously and precisely, providing reliable analyses in real time. In an emergency situation, this functionality allows intervention personnel to act quickly and confidently, based on precise and up-to-date information.

[120] The means for administering the medicinal composition are then automatically controlled by unit 24 when at least one of said threshold values is crossed. The unit 24 controls these means of administration so that the corresponding medicinal indication (choice of the medicinal composition administered) and/or the dosage (quantity and frequency of administration) improve or stabilize the patient's condition.

[121] The unit 24 thus controls the administration module 22, depending on the result of the measurements (defining a notion of control loop) and this in synchronization with the respiratory cycle, that is to say with drug administration during the inspiratory phase and according to predefined modalities (dosages).

[122] As a non-limiting illustrative example, threshold values recorded in the memory area of unit 24 can be: a SpCL less than 92%, a FR greater than 25 cycles per minute or less than 10 cycles per minute , a HR greater than 110 beats per minute (bpm) or less than 50 bpm, a Hypoxemic Index less than 1.3, an ROX score less than 2 or 3.

[123] The medicinal composition administered will generally depend on a pathology known to the patient and/or the context. For example, in a fire victim with a Hypoxemic Index less than 1.3, the medicinal composition could be oxygen or a gas mixture enriched with oxygen and/or an antidote (for example a mixture of benzodiazepines and anexate). . For example again, in an asthmatic patient, an SpCL less than 92% associated with an RF greater than 25 cycles per minute and/or an ROX score less than 2, the medicinal composition could be a corticosteroid. Still as an explanatory example, for a patient with a HR less than 50 bpm, the medicinal composition could be adrenaline. THE monitoring allows the unit 24 to manage the drug dosage according to the evolution of the patient's condition, in particular the evolution of the measured and monitored characteristics of the respiratory function.

[124] Each measured characteristic and/or each calculated clinical indicator can be associated with different threshold values reflecting different degrees of severity of the patient's condition. For example, FR threshold values can be: FR >25 cycles per minute; EN>35 cycles per minute; FR <10 cycles per minute; FR<5 cycles per minute. Each time these threshold values are crossed, the unit 24 adapts the medicinal indication and/or the dosage) of the predetermined values.

[125] When the patient's condition is improved or stabilized, and the characteristics and/or clinical indicators monitored return to acceptable values, the unit 24 can recommand the administration means to stop the administration of the medicinal composition.

[126] According to one embodiment, when the unit 24 detects the crossing of one or more of the threshold values, it triggers a visual and/or audible alarm 26 arranged on the external part 20, preferably on its front face to provide a clear and direct viewing angle. Activation of this alarm 26 as soon as threshold values are detected is particularly useful in noisy or chaotic environments. These alerts help personnel immediately recognize critical situations, even without directly consulting the screen 25. In contexts where attention may be reduced or in cases of limited visibility, this alarm offers a rapid and effective means of communication. The alarm 26 may include one or more high intensity red or orange LEDs, flashing lights or strobes, beeps of different frequencies or tones to indicate different types of alerts or conditions, pre-recorded voice messages, useful particularly in situations where staff may not be able to read or concentrate on the screen 25.

[127] The threshold value(s) are preferably displayed on the display module 25 so that the operator can quickly make a precise diagnosis of the patient's state of health. The operator will then be able to determine the medicinal composition best suited to this situation. He could, for example, connect a cartridge to the external part 20 and manually activate the means for administering the medicinal composition contained in said cartridge. [128] According to one embodiment, the means for administering the medicinal composition are also automatically controlled by the unit 24, according to a control loop with the module for collecting biometric and biological parameters, in order to maintain all or part of the measured characteristics of respiratory function and/or clinical indicators to acceptable target values corresponding to an improved or stabilized state of the patient, which target values are obviously different from the threshold values.

[129] The drug administration means 22 ensures the diffusion of the drug composition in liquid or preferably gaseous form. Also, according to one embodiment, the means of administration comprise means of aerosolization (for example means of vaporization or spraying) of the medicinal composition, so that said composition is administered in aerosol form. In doing so, the medicinal composition is easily and quickly distributed and then assimilated by the patient. In a preferred embodiment, the aerosolization of the medicinal composition is carried out via a piezoelectric vaporizer.

[130] Some rescues may intervene in difficult contexts such as fires, explosions, attacks, epidemics, etc. In these situations, the degraded state of a patient may be due to exogenous factors (smoke, carbon monoxide, toxic gases, etc.). To diagnose and/or best assess the clinical situation of a patient in these conditions, the tip 10 or the external part 20 advantageously comprise a particle filter 31 configured to recover particles during the patient's expiratory phases. The recovered particles may be physical particles (polluting elements such as fine particles, gases) or biological particles (bacteriological, viral, parasitic elements).

[131] The filter 31 advantageously consists of an antibacterial and/or antiviral filter so as to have a filtering action with respect to viruses and/or bacteria, thus playing a role in preventing contamination.

[132] According to one embodiment, the trapped particles are then analyzed by the filter 31. The filter 31 can thus play a role in identifying respiratory damage, of a biological and/or chemical nature, in particular by integrating diagnostic marker in said filter, for example colorimetric. The particles trapped by the filter 31 can also be analyzed by the processing unit 24 so as to supply the patient's biometric and/or biological information. [133] Also, the embodiment illustrated by the appended figures comprises a conduit for gas mixture 40 integrated into the external part 20. This conduit 40 comprises an inlet orifice 41 for connecting said conduit 40 to a source of gas mixture called therapeutic, not shown in the appended figures, and an outlet 42 communicating fluidly with the central recess 13 of the orofacial tip 10 so that the patient can directly receive this gas mixture. The conduit 40 can then be considered as a drug administration module, the medicinal composition administered being the gas mixture. This gas mixture is suitable for supplementing the patient's respiratory system and is preferably in the form of pure oxygen or oxygen-enriched air, i.e. therefore with a level (or concentration) of dioxygen greater than 21%, advantageously equal to or greater at 90%. The gas mixture is advantageously pressurized - or compressed - (hyperbaric mode) to ensure the genesis of inspiratory assistance.

[134] The gas mixture can also be used as a vector for diffusing the medicinal composition infused via the medicinal administration module 22. The administrator is then adapted to infuse the patient with a therapeutic treatment comprising the superoxygenated medicinal composition. Of course, the medicinal composition can also be administered to the patient without requiring delivery of the gas mixture.

[135] According to one embodiment, the processing unit 24 automatically adjusts the composition and/or flow rate of the gas mixture, during the patient's inspiratory and expiratory phases, when at least one of the aforementioned threshold values is crossed (values thresholds of measured characteristics of respiratory function and/or threshold values of function indicators of said characteristics).

[136] The composition of the gas mixture can in particular be adjusted by adjusting the CL level of the mixture. The unit 24 can for example control the opening of an orifice fitted on the external part 20 and/or on the nozzle 10 and allowing the gas mixture to be diluted with the ambient air to reduce its CL rate. The flow rate of the gas mixture can for example be adjusted by means of a flow meter connected to conduit 40 and controlled by unit 24.

[137] The external part 20 can also include a regulator for managing the pressure of the gas mixture passing through or via the conduit 40. In the same way as for its composition or its flow rate, the pressure of the mixture is adjusted automatically by the unit 24, at a determined pressure value, when at least one of the aforementioned threshold values is crossed.

[138] Each measured characteristic and/or each calculated clinical indicator can be associated with different threshold values reflecting different degrees of severity of the patient's condition. Each time these threshold values are crossed, the unit 24 adapts the composition and/or the flow rate and/or the pressure of the gas mixture to predetermined values.

[139] In the mode of execution chosen to illustrate the invention, the administrator 1 comprises an auxiliary conduit 50 for a gas mixture in addition to the conduit 40 so that it is possible to administer two gas mixtures to the patient distinct, simultaneously or at distinct intervals.

[140] When the patient's condition is improved or stabilized, and the characteristics and/or clinical indicators monitored return to acceptable target values, the unit 24 adjusts the composition and/or flow and/or pressure again. of the gas mixture, to other predetermined values. In other words, the unit 24 controls the composition and/or the flow rate and/or the pressure of the gas mixture, depending on the result of the measurements (defining a notion of a control loop) and this in synchronization with the respiratory cycle.

[141] Some patients, depending on their condition, may have an inability to ventilate spontaneously. An indication may then consist of keeping their airways under pressure during expiration. To do this, the tip 10 or the external part 20 advantageously comprises an expiratory brake whose resistance is advantageously adjustable. This brake ensures the genesis of a positive expiratory pressure (PEEP) capable not only of maintaining the pulmonary alveoli dilated, but also of improving oxygenation by increasing functional residual capacity. According to a preferred embodiment, the resistance of the expiratory brake is automatically adjusted by the unit 24, to a determined resistance value, when at least one of the aforementioned threshold values is exceeded. The brake can for example be in the form of a propeller placed in the path of the aforementioned expiratory channel and rotated by a micromotor. When at least one of the aforementioned threshold values is exceeded, the unit 24 adjusts/regulates the micromotor so that it generates a resistance motor torque corresponding to the desired resistance value. This expiratory brake can also be useful in a non-therapeutic setting, for example in a sporting context in order to improve the respiratory capacities of the individual (e.g.: increase in functional residual capacity).

[142] The attached Figures 8 to 10 illustrate the device/administrator 1 in its nasal version. In this version the tip 10 is of the nasal type, said tip consists of a mask intended to cover or cover the two nasal orifices of the patient, preferably said mask being held against said two orifices thanks to a strap or strap 6 of which the two ends are fixed to said mask.

[143] All the essential, advantageous and/or optional elements described above in connection with the orofacial version of the device/administrator 1 are present and similar in the nasal version of said device/administrator, except of course the tip 10 which is adapted to the nasal respiratory tract at which it must be positioned.

[144] As can be seen in Figures 9 and 10, in this nasal version, the reflectance pulse oximeter 30 is located on the proximal portion 11 of the nasal tip 10 so as to take measurements at the level of the upper lip of the individual/patient, advantageously at the level of the external face of said lip, without causing ischemia.

[145] Furthermore, in this nasal version, the external part 20 is advantageously constituted identically to that of the oral version. In particular, the nasal tip 10 comprises a central recess 13, in direct connection with the two nasal orifices, in fluid communication with the main opening 21 of the external part 20. The central recess 13 can consist of a large recess covering the two nasal orifices or this central recess 13 can be subdivided into two conduits opening respectively towards or into a nasal orifice.

[146] The nasal tip 10 has a shape adapted to a human nose and is advantageously made of a flexible material or sufficiently flexible to adapt, by plating, to the morphology of human noses. The nasal tip 1 is held in place on or against the nose using at least one elastic and/or length-adjustable strap or strap intended to be placed behind the head of the individual/patient.

[147] The arrangement of the different elements and/or means and/or steps of the invention, in the embodiments described above, should not be understood as requiring such an arrangement in all implementations. In any case, it will be understood that various modifications can be made to these elements and/or means and/or steps, without departing from the spirit and scope of the invention. Especially :

- the shape and dimensions of the device/administrator 1 as well as the arrangement of the different modules 22, 24, 25, 27, 29, 290, 30, 31 on or in said device/administrator, may vary;

- the shape and dimensions of the end piece 10 and/or the external part 20 may vary;

- the shape and dimensions of the gas mixture conduit 40 as well as its means of communication with the central recess 13 may vary.

[148] Additionally, one or more features set forth only in one embodiment may be combined with one or more other features set forth only in another embodiment. Likewise, one or more characteristics presented only in one embodiment can be generalized to other embodiments, even if this or these characteristics are described only in combination with other characteristics. In particular, the administration module 29, 290 of the tissue perfusion modulating agent and/or the drug administration module 22 can operate and perform their function(s) independently of the display module. 25 and the alarm 26, to the extent that these elements 25, 26 do not interact and/or do not produce a technical effect on said modules. In other words, the device can be as mentioned in the main claim, the characteristics relating to the display module 25, the alarm 26 and its triggering being however replaced by the characteristics relating to the administration module 29 , 290 of the tissue perfusion modulation agent and/or by the characteristics relating to the drug administration module 22. In the case where the administration module of the tissue perfusion modulation agent is presented under the form of the patch 290, the characteristics relating to the memory area of the processing unit 24 can also be substituted by the technical characteristics of said patch.

[149] Although the invention has been described in connection with several particular embodiments, it is obvious that it is in no way limited there and that it includes all the technical equivalents of the means described as well as their combinations if these fall within the scope of the invention. [150] The use of the verb “include”, “understand” or “include” and its conjugated forms does not exclude the presence of other elements or other steps than those set out in a claim.

[151] In the claims, any reference sign in parentheses cannot be interpreted as a limitation of the claim. ]

Claims

Claims [Claim 1] [Device for characterizing the inspiratory and expiratory phases of the respiratory function of an individual, the device comprising: - a tip (10) intended to be positioned at least partially at the level of a respiratory tract, having a proximal portion (11) having a central recess (13) intended to be positioned in the mouth of the individual or in front of the orifices of the individual's nose, - an external part (20) intended to be positioned outside the body of the individual, secured to the tip, having at least one main opening (21) communicating with the central recess (13) of the tip, characterized in that: - the tip (10) integrates an optical reflectance pulse oximeter (30) configured to measure the capillary oxygen saturation (SpCh) of the individual, which oximeter is arranged to, in use, be positioned against a lip of the individual, which oximeter comprises at least one light source (301) and at least one light detector (302) arranged on the same side of said lip to measure the SpCh by reflectance, - the tip (10) or the external part (20) incorporates a pressure sensor (27) arranged so as to measure the pressures of gas inspired by the individual during the inspiratory phases and the pressures of gas expired by the individual during the expiratory phases, - the tip (10) or the external part (20) integrates a processing unit (24) of the data coming from the pulse oximeter (30) and the pressure sensor (27), which unit is configured to calculate, in real time and from said data, all or part of the following characteristics of the respiratory function of the individual and/or the variation of said characteristics according to the inspiratory and expiratory phases: the SpCh, the heart rate (HR), the respiratory rate (RR), the inspiratory and expiratory pressures, - the processing unit (24) comprises a memory zone in which threshold values of the measured characteristics of respiratory function and/or threshold values of clinical indicators depending on said characteristics are recorded or calculated, - the processing unit (24) is configured to trigger a visual and/or alarm (26) sound arranged on the external part (20) when said unit detects the crossing of one or more of the threshold values, - a display module (25) is installed in a visible manner on the external part (20), which module displays: the characteristics of the individual's respiratory function calculated by the processing unit (24) and the threshold values. [Claim 2] Device according to claim 1, in which the display module (25) is positioned on the front face of the external part (20). [Claim 3] Device according to claim 2, in which the front face of the external part (20) is perpendicular or substantially perpendicular to a longitudinal axis of the end piece (10). [Claim 4] Device according to one of the preceding claims, further comprising at least one administration module (29, 290) of an agent for modulating the tissue perfusion of the oral mucosa of the individual, said module being configured to administer said agent at the proximal portion (11) of the tip (10). [Claim 5] Device according to claim 4, in which the administration module (29) of the modulation agent is controlled by the processing unit (24) so as to automatically administer said agent when said unit detects the crossing of one or more of the threshold values. [Claim 6] Device according to one of claims 4 or 5, in which the administration module (29) of the modulating agent is controlled manually, via a push button or the like placed on the external part (20) . [Claim 7] Device according to one of claims 4 to 6, in which the administration module (29) of the modulating agent comprises means for aerosolizing said agent, so that said agent is administered in the form of aerosol in the central recess (13). [Claim 8] Device according to one of claims 4 to 7, in which the module for administering the modulation agent comprises or is in the form of a patch (290) containing said agent, which patch is arranged for, in use, to be positioned against the lip of the individual, at least at the level of the oximeter (30). [Claim 9] Device according to one of claims 4 to 8, wherein the tissue perfusion modulating agent comprises a vasodilator, a hydrating agent, or a combination thereof. [Claim 10] Device according to one of the preceding claims, in which the processing unit (24) is configured to calculate, on each respiratory cycle, the time of the respiratory cycle devoted to inspiration, the time of the respiratory cycle devoted to expiration, and/or the inspiratory and expiratory flow rates. [Claim 11] Device according to one of the preceding claims, in which the tip (10) or the external part (20) integrates a gas analyzer (28) adapted to measure the fraction of at least one inspired gaseous component and/or exhaled by the individual, the processing unit (24) being configured to calculate, on each respiratory cycle, the Inspired Fraction of said gas component and the Exhaled Fraction of said gas component. [Claim 12] Device according to claim 11, in which: - the gas analyzer (28) includes an oxygen sensor making it possible to measure the Inspired Fraction of Oxygen (FiO2) and the Exhaled Fraction of Oxygen (FeO2), - the processing unit (24) is configured to calculate a Hypoxemic Index severity score defined by the ratio (SpO2/FR) and/or an ROX severity score defined by the ratio [(SpO2/FiO2)/FR], - threshold values of the Hypoxemic Index severity score and/or the ROX severity score are recorded or calculated in the memory area of the processing unit (24), - the display module (25) also displays the threshold values of the Hypoxemic Index severity score and/or the ROX severity score. [Claim 13] Device according to one of claims 1 to 12, in which the tip (10) is of the oral-facial type, said tip consisting of a diving snorkel tip or a mouthpiece for a diving regulator, the proximal portion (11) being intended to be positioned in the mouth of the individual abutting against his jaw or his teeth, the distal portion (12) forming a protuberance extending between the lower and upper teeth of the individual. [Claim 14] Device according to one of claims 1 to 12, in which the tip (10) is of the nasal type, said tip consists of a mask intended to cover or cover the two nasal orifices of the individual, preferably said mask being held against said two orifices by means of a strap or thong (6) whose two ends are fixed to said mask. [Claim 15] Device according to one of the preceding claims, in which the tip (10) or the external part (20) integrates a spirometer to measure the inspiratory and expiratory flow rates. [Claim 16] Device according to one of the preceding claims, in which the tip (10) or the external part (20) comprises an expiratory brake. [Claim 17] Facial administrator (1) for a patient characterized in that it comprises the device according to one of the preceding claims, and in which the external part (20) comprises a drug administration module (22, 40, 50) of a medicinal composition in fluid form or in powder form, said administration module (22, 40, 50) comprising administration means allowing administration of the medicinal composition through the main opening (21) during inspiratory phases. [Claim 18] Administrator according to claim 17, in which the means for administering the medicinal composition are automatically controlled by the processing unit (24) when at least one of said threshold values is crossed. [Claim 19] Administrator according to one of claims 17 or 18, in which the means for administering the medicinal composition are controlled manually, via a push button or the like placed on the external part (20). [Claim 20] Administrator according to one of claims 17 to 19, in which the means of administration comprise means of aerosolizing the medicinal composition, so that said composition is administered in the form of an aerosol. [Claim 21] Administrator according to one of claims 17 to 20, in which the tip (10) or the external part (20) comprises a particle filter (31) configured to recover particles during the expiratory phases of the patient, advantageously said particle filter (31) further consisting of an antibacterial and/or antiviral filter, the processing unit (24) and/or said filter being configured to analyze said recovered particles. [Claim 22] Administrator according to one of claims 17 to 21, in which: - the external part (20) comprises a conduit for a gas mixture (40) having an outlet orifice (42) communicating with the central recess (13) of the nozzle (10) and an inlet orifice (41) present on the external part (20), advantageously said inlet orifice (41) being intended to connect to an external conduit for the administration to the patient of a so-called therapeutic gas mixture, - the composition and/or flow rate of the gas mixture being automatically adjusted by the processing unit (24), during the inspiratory and expiratory phases, when at least one of the threshold values is crossed. [Claim 23] Administrator according to claim 22, in which the external part (20) comprises a regulator for managing the pressure of the gas mixture passing in or via the above-mentioned gas mixture conduit (40), the pressure of said gas mixture being automatically adjusted by said processing unit (24), to a determined pressure value, when at least one of the threshold values is crossed. [Claim 24] Administrator according to one of claims 17 to 23 taken in combination with claim 16 and one of claims 18 or 22, wherein the expiratory brake is configured to have an adjustable resistance, which resistance is adjusted automatically by said processing unit (24), at a determined resistance value, when at least one of the threshold values is crossed.]