Non-invasive respiratory support system including a medical device for maintaining airway patency

Abstract

The invention relates to a non-invasive respiratory assistance system (10) comprising, above, a respiratory mask (11), anatomically shaped to cover at least the nose of a patient's face, said mask (11) comprising a front face (13) and a through channel (14), intended to be hermetically connected with an artificial ventilation device, and a medical device (1) for maintaining the patency of the respiratory tract, comprising a longitudinal guide (2); gripping means (3) and a member (4) comprising a spatula; said system (10) comprising means for fixing and locking said device (1) when inserted into the mouth of said patient; said device (1) being mounted through between said mask (11) and said fixing and locking means, said gripping means (3) and said control means (5) being located on the side of the front face (13) of said mask (11). Figure for the abstract: Fig. 20

Description

Title of the invention: Non-invasive respiratory assistance system comprising a medical device for maintaining airway patency Technical field of the invention

[0001] The present invention falls within the medical field of respiratory assistance and artificial ventilation, in particular during general anesthesia.

[0002] As is known, during the medical care and treatment of a patient, in the event of distress or respiratory failure, but also during a surgical intervention resulting in general anesthesia or anesthesia of the anatomical parts conditioning the proper functioning of the respiratory tract, it is necessary to set up respiratory assistance for said patient. This respiratory assistance makes it possible to simulate the biological function of respiration and to ensure gas exchanges, for the entire duration when the functioning of the respiratory tract is no longer ensured naturally.

[0003] Further, the establishment of respiratory assistance can be carried out invasively, for example by performing intubation or by performing a tracheotomy, bringing air directly into the patient's trachea through a tube.

[0004] Respiratory assistance can also be performed non-invasively, by applying a respiratory mask covering the patient's face and ensuring artificial ventilation only through the orifices and cavities of the upper airways (i.e. the mouth and nose).

[0005] In addition, respiratory assistance can be carried out manually, generally by first aiders and nursing staff during an emergency intervention, commonly using a valved bag mask or "BAVU" (for "Self-Filling Balloon with Unidirectional Valve") type resuscitator.

[0006] During a planned surgical procedure, respiratory assistance is generally performed mechanically, by connecting a dedicated device, such as an artificial respirator or assisted mechanical ventilation, to the tube or mask.

[0007] The invention specifically relates to non-invasive respiratory assistance, of the respiratory mask type.

[0008] That being said, maintaining airway patency and ensuring respiratory function at the required level is one of the fundamental tasks during a medical intervention, especially in the case of anesthesia. Indeed, trauma or unconsciousness causes a decrease or loss of muscle tone, which can lead to obstruction of the airways, through a blockage of the entrance from the larynx by the epiglottis and the root of the tongue.

[0009] It is therefore necessary to clear the airways and keep them clear.

[0010] The invention also relates to a medical device for maintaining the permeability of the respiratory tract, intended to be preferably combined with a non-invasive respiratory assistance system, of the respiratory mask type. State of the art

[0011] Many existing devices attempt to solve this problem. We know the intubation probe, which has major drawbacks, such as traumatic and complex implantation for the intubation probe tube.

[0012] We also know the laryngeal mask, which is likely to move or be poorly positioned, inducing harmful air leaks.

[0013] Furthermore, such devices generally include a tube connecting them to the apparatus providing ventilation, which makes it less physiological and natural for the patient, or even traumatic. Statement of the invention

[0014] The invention aims to overcome the drawbacks of the state of the art by proposing a respiratory assistance system in the form of a mask combined with a medical device for maintaining the permeability of the respiratory tract, without a tube and acting on the cavities naturally used for breathing. In particular, said device is limited to acting on the root of the tongue and the associated epiglottis, avoiding the reflexogenic zones of the trachea and the larynx, which facilitates its implantation and extraction, reducing the risks of trauma.

[0015] In short, the device allows the tongue to be held out, to clear the airways and ensure the patient's breathing.

[0016] Furthermore, the assistance system provides elements to enable said device to be positioned and maintained, facilitating this operation and the stages of anesthesia for the patient.

[0017] To this end, the invention relates to a non-invasive respiratory assistance system, of the respiratory mask type. Such a system is specifically dedicated to the medical device for maintaining the patency of the respiratory tract.

[0018] According to the invention, such a system comprises - superiorly, a respiratory mask, anatomically shaped to cover at least the nose of a patient's face, said mask comprising a front face and a through channel, intended to be hermetically connected with an artificial ventilation device; - a medical device for maintaining airway patency including - at least one longitudinal guide (2) extending along a curved path; - gripping means (3) connected to a proximal end (21) of said longitudinal guide (2); - at least one member (4) mounted at a distal end (20) of said longitudinal guide (2), said organ (4) comprising a spatula shaped complementary to the lingual anatomy, said member (4) being movable in displacement relative to said longitudinal guide (2) from a retracted position to a deployed position, and vice versa, i) in the retracted position, the spatula of said member (4) extends along said trajectory of said longitudinal guide (2) ii) in the deployed position, said member (4) extends downwardly projecting relative to said longitudinal guide (2); said medical device (1) further comprising mounted at said proximal end, means (5) for controlling the movement of said organ (4) between the retracted and deployed positions;

[0019] Advantageously, the system comprises - means for fixing and locking said device when inserted into the mouth of said patient; - said device being mounted through between said mask and said fixing and blocking means, said gripping means and said control means being located on the side of the front face of said mask.

[0020] According to additional, non-limiting characteristics, said locking and fixing means comprise a compartment with a rear face anatomically shaped to come into contact with and at least partially cover the patient's jaw; said compartment being connected below said mask in a removable manner.

[0021] According to one embodiment, said blocking and fixing means comprise an interdental spacer, anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth, with an upper part and a lower part, said interdental spacer being crossed by said medical device, between said organ and said gripping means.

[0022] According to one embodiment, the upper part of the interdental spacer is mounted integrally projecting from a rear face of said mask.

[0023] According to one embodiment, said lower part of the interdental spacer is integral with said compartment and provided as a projection from its rear face.

[0024] According to one embodiment, said compartment is mounted articulated on said mask between an open position and a closed position, in particular according to a translation.

[0025] According to one embodiment, said respiratory mask comprises a removable section, cooperating in a frontally interlocking manner on said mask covering the nose of the patient's face.

[0026] Preferably, said removable section comprises said through channel.

[0027] According to one embodiment, the system comprises means for maneuvering the compartment between a closed position and an open position, preferably from the closed position to the open position, in particular in translation.

[0028] According to one embodiment, said means for maneuvering the compartment comprise at least one lever mounted on the front face of the rotating mask inducing the translation of the compartment.

[0029] According to one embodiment, said at least one longitudinal guide of said medical device comprises at least one channel for inserting and extracting medical instruments. Presentation of the drawings

[0030] Other characteristics and advantages of the invention will emerge from the detailed description which follows of the non-limiting embodiments of the invention, with reference to the appended figures, in which:

[0031] [Fig.l] schematically represents a front perspective view of an embodiment of a respiratory assistance system, with blocking means in the form of an interdental spacer, ensuring the fixing of a medical device for maintaining the permeability of the respiratory tract, in the retracted position;

[0032] [Fig.2] schematically represents a perspective side view of an embodiment of said medical device, in the retracted position, cooperating with fixing and blocking means in the form of an interdental spacer;

[0033] [Fig.3] schematically represents a profile view of an embodiment of the medical device alone in the retracted position;

[0034] [Fig.4] schematically represents a view similar to [Fig.3], showing said medical device in the deployed position, as well as the direction of sliding actuation of the control means relative to the gripping means for the passage from the retracted position to said deployed position;

[0035] [Fig.5] schematically represents a view along a vertical section of the implementation of the medical device introduced in the retracted position into the patient's oral cavity;

[0036] [Fig.6] schematically represents a view similar to [Fig.5], showing the medical device tilted into the deployed position, coming to bear to maintain the base of the language;

[0037] [Fig.7] schematically represents a perspective view from above of a second embodiment of said system, equipped with means for locking the medical device, in the form of a lip support mounted in fixation through a plate according to one of the positions indexed along the longitudinal guide of said device;

[0038] [Fig.8] schematically represents a perspective view from below similar to [Fig.7], showing in particular the indexing notches of said plate;

[0039] [Fig.9] schematically represents a front perspective view similar to [Fig.7], showing in particular the front face of said lip support;

[0040] [Fig. 10] schematically represents a rear perspective view from above of a third embodiment of the system, equipped with means for locking the medical device, in the form of a compartment cooperating at the bottom in a nested manner with the mask;

[0041] [Fig. 11] schematically represents a front perspective view from below similar to [Fig. 10], highlighting in particular the fitting of said compartment on the lower part of said mask;

[0042] [Fig. 12] schematically represents a profile view of another embodiment of the medical device, in the retracted position and equipped with a longitudinal guide forming a channel for inserting and extracting medical devices;

[0043] [Fig. 13] schematically represents a perspective view of the rear face of an embodiment of the longitudinal guide of the medical device, with four channels of different diameters;

[0044] [Fig. 14] schematically represents two views according to a vertical section of the implementation of the medical device introduced into the oral cavity of the patient, in a retracted position and in a deployed position, showing in particular the joint movement of the rear end of the guide channel with the movement of the organ;

[0045] [Fig. 15] schematically represents a front perspective view of another embodiment of a respiratory assistance system, with a mask provided with a removable section, in the nesting position on said mask;

[0046] [Fig. 16] schematically represents a view similar to [Fig. 15], showing said removable section retracted from said mask;

[0047] [Fig. 17] schematically represents a rear perspective view of another embodiment of a respiratory assistance system, the rear face of said mask being equipped with the upper part of the interdental spacer, while the rear face of the compartment is equipped with the lower part, said compartment being in the open position;

[0048] [Fig. 18] schematically represents a front perspective view of another embodiment of a respiratory assistance system, in the closed position of the com compartment, with a first configuration of the means for operating said compartment in the form of a single lever;

[0049] [Fig. 19] schematically represents a front perspective view of another embodiment of the system, in the closed position of the compartment, with a second configuration of the means for maneuvering said compartment in the form of a double lever; and

[0050] [Fig.20] schematically represents a front perspective view of another mode of realization of the system, in the open position of the compartment, with a second configuration of the means for maneuvering said compartment in the form of a double lever. Detailed description

[0051] The present invention relates to respiratory assistance and artificial ventilation, in particular during general anesthesia. To this end, the invention relates to a medical device 1 for maintaining the patency of the respiratory tract, hereinafter referred to as "device 1", as well as a respiratory assistance system 10, hereinafter referred to as "system 10", equipped with such a device 1.

[0052] Firstly, the device 1 is intended to free the circulation along the respiratory tract and maintain this circulation, by pressing against the base or root of the tongue to press it forward, namely towards the frontal or anterior anatomical part of the patient's skull).

[0053] To do this, the device 1 comprises at least one longitudinal guide 2. According to the embodiment visible in the figures, the device 1 comprises two guides 2 extending parallel and spaced apart from each other.

[0054] Each guide 2 can have any shape and section, preferably a flattened shape, like a blade, with one or more segments, allowing it to be easily inserted when it is placed in the oral cavity.

[0055] Furthermore, the length of the guide 2 is sufficient to allow the insertion of its distal end 20 until it penetrates into the throat of a patient, close to the root of the patient's tongue, while maintaining a proximal end 21 outside the mouth. Preferably, the length of the guide 2 is greater than the length of the oral cavity of an adult patient, allowing its insertion up to the root of the tongue, but also to adapt the portion of the guide 2 introduced into the oral cavity according to the size of the latter.

[0056] Thus, the guide 2 serves in part to stiffen the part intended to be introduced into the mouth, as well as to support other elements.

[0057] Furthermore, said guide 2 extends along a curved trajectory, namely it has a downward inflection from the proximal end 21 to the distal end 20. Such an inflection gives a concave shape below the guide 2, allowing it to adapt to the oral morphology, in particular to match the shape of the curve of the tongue. This curved trajectory can be given by an arched and rounded shape of the guide 2, or by angles between its segments.

[0058] Further, the device 1 comprises gripping means 3 connected to the proximal end 21 of said longitudinal guide 2. Such gripping means 3 may be of any shape and are adapted to allow the device 1 to be held and manipulated by a practitioner.

[0059] According to one embodiment, visible in the figures, the gripping means 3 comprise a handle forming a hollow female part. This female part can be of any shape, preferably in the form of a half-tube, open towards the front. The rear wall of the handle then serves as a surface on which the practitioner's fingers can be positioned to grip and hold the device 1. In addition, the proximal end 21 can be positioned between two fingers, when gripping the device 1, ensuring that it is firmly held in the hand.

[0060] According to the embodiments visible in the figures, said handle extends orthogonally or essentially orthogonally relative to said curved trajectory of said guide 2 at its proximal end 21. Thus, when the guide 2 is positioned horizontally or essentially horizontally inside the oral cavity, then the handle extends vertically or essentially vertically.

[0061] According to different embodiments, visible in figures 1 to 11, said handle extends symmetrically or substantially symmetrically on either side of the guide 2. According to another embodiment, as visible in figures 12 to 14, the handle extends under the guide 2.

[0062] Furthermore, the device 1 comprises at least one member 4 mounted at the distal end 20 of said longitudinal guide 2. In addition, said member 4 comprises a spatula shaped to complement the lingual anatomy.

[0063] In particular, said spatula has a flat, rounded and curved shape, concave at the bottom. In addition, the edges of said spatula are rounded, to avoid any risk of injury during introduction and extraction, as well as during use of said device 1.

[0064] Advantageously, the device 1 provides for pressing on the base of the tongue, in order to press it forward, keeping the airways open.

[0065] To do this, said member 4 is movable in displacement relative to said longitudinal guide 2 from a retracted position to a deployed position, and vice versa.

[0066] In the retracted position, the spatula of said member 4 extends along said trajectory of said longitudinal guide 2. In other words, said spatula extends in the extension of the guide 2, allowing the insertion and extraction of the device 1 within the cavity. buccal, until said spatula reaches the base of the tongue. Such a retracted position in insertion of the device 1 within an oral cavity is highlighted in [Fig.5].

[0067] In the deployed position, said member 4 extends downwardly projecting relative to said longitudinal guide 2. In other words, the member 4 forms an angle relative to said trajectory at the distal end 20, so as to press on the base of the tongue. Such a deployed position of the member 4 for pushing back the tongue by pressing on its base is highlighted in [Fig.6].

[0068] Furthermore, the transition from one position to another, as well as the maintenance in the deployed position of the member 4, is ensured by the practitioner taking hold of the gripping means 3.

[0069] To do this, said medical device 1 also comprises, mounted at said proximal end 21, means 5 for controlling the movement of said member 4 between the retracted and deployed positions.

[0070] According to the corresponding embodiment, the control means 5 may be in the form of a male part shaped complementary and intended to cooperate within said female part of the gripping means 3, in the deployed position of said member 4. In particular, in the case of a semi-tubular female part, the male part has a cylindrical shape, preferably a half-cylinder shape with the wall of revolution on the side of the hollow of said female part. The dimensions of the male and female parts are complementary, namely that the external dimensions of the male part correspond to the clearance near the internal dimensions of the female part, in particular the diameter of the male part is equivalent to the clearance near the internal diameter of the female part. Such a complementary configuration is notably visible in Figures 3 and 4.

[0071] Thus the male part of the control means 5 can be inserted into the female part of the gripping means 3 during actuation to move the member 4 from the retracted position to the deployed position, and can be extracted therefrom during the movement from the deployed position to the retracted position (or vice versa). In short, the movement of the control means 5 towards or away from the gripping means 3 makes it possible to actuate the member 4 between its deployed and retracted positions. [Fig. 4] shows in particular a movement towards the control means 5 towards the gripping means 3, actuating the deployment of the member 4 from the retracted position to the deployed position.

[0072] According to corresponding embodiments, the male part is aligned with the female part, symmetrically or substantially symmetrically with respect to the rod 50 (i.e. with respect to the guide 2), or else said male part extends under said rod 50.

[0073] According to one embodiment, one and / or the other of the male and / or female parts can be provided as removable, relative to the rod 50 and / or said guide 2, allowing them to be removed once the device 1 is in place. This removable nature also makes it easier to clean these parts.

[0074] Concerning the mobility of the spatula, according to one embodiment, said member 4 is mounted as an extension of said distal end 20 of said longitudinal guide 2. In addition, said member 4 is pivotally articulated between the retracted and deployed positions. In other words, the member 4 rotates around the distal end 20, downwards to reach the deployed position, and conversely upwards to return to the retracted position. In particular, the transition to the deployed position is carried out by a clockwise rotation, while the return to the retracted position is carried out by a counterclockwise rotation.

[0075] [Fig.4] highlights the clockwise rotation direction towards the deployed position of said organ 4.

[0076] According to one embodiment, the member 4 is mounted in rotation through first rings 6, secured to a front end of the spatula, at the junction with the guide 2. These first rings 6 are secured to the distal end 20 of the guide 2. In particular, a pair of first rings 6 is secured to each distal end 20 of the two guides 2.

[0077] Each first ring 6 can be free to rotate with said guide 2 and fixed on the member 4, or vice versa.

[0078] According to other embodiments, the member 4 may be provided with an axis or a shaft mounted in rotation on the distal end 20 of the guide(s) 2.

[0079] According to yet another embodiment, the member 4 can be mounted on the distal end 20 through an elastic joint, in particular made of a material allowing it to be bent or flexed relative to the guide 2, such as for example natural or synthetic rubber.

[0080] According to a preferred embodiment, the actuation of the member 4 is carried out through a mechanical connection similar to a cam, namely that a translation confers the rotational movement of the member 4.

[0081] To do this, according to one embodiment, as visible in the figures, said control means 5 comprise at least one rod 50 connected at one end in rotation with said member 4.

[0082] According to another equivalent embodiment, said at least one rod 50 may be in the form of a rigid or semi-rigid, or even flexible, connection, such as for example in the form of a cable. In this case, the control means 5 may operate, alone or in combination with the gripping means 3, like a bicycle brake handle.

[0083] According to one embodiment, the member 4 is mounted in rotation through second rings 7, secured to a front end of the spatula, at the junction with the rod 50. These second rings 7, in particular in the form of a pair, are secured to the rear end of the rod 50.

[0084] Each second ring 7 can be free to rotate with the rod 50 and fixed on the member 4, or vice versa.

[0085] According to other embodiments, the member 4 may be provided with an axis or a shaft mounted in rotation on the rear end of the rod 50.

[0086] In addition, said rod 50 is mounted to slide relative to the longitudinal guide 2. According to the corresponding embodiment, the rod 50 is mounted to slide within the spacing between the two guides 2. In other words, the rod 50 moves in translation relative to the guide 2, in particular relative to the two guides 2 which frame it, serving as longitudinal guidance.

[0087] Preferably, the rod 50 slides along the guide(s) 2, through a sliding connection.

[0088] According to one embodiment, like the guide 2, the rod 50 may have a flattened shape, with one or more segments, as well as a curvature or inflections parallel to or along said trajectory.

[0089] According to another embodiment, said rod 50 is part of said guide 2, in telescopic form, allowing elongation for the activation of the member 4 towards the deployed position (or towards the retracted position), or conversely during its narrowing (or reciprocally towards the deployed position).

[0090] Further on, the sliding of said rod 50 relative to said longitudinal guide 2 ensures, in one direction, a tilting of said member 4 from the retracted position to the deployed position. In particular, the translational movement from the front to the rear of the device 1 (i.e. from the frontal or anterior anatomy part of the skull to the posterior part), actuates the rotation of said member 4 to the deployed position, namely when pushing on the control means 5.

[0091] In a reverse direction, the sliding of the rod 50 ensures the return of said member 4 from the deployed position to the retracted position. In particular, the translational movement from the rear to the front, actuates the rotation of said member 4 to the retracted position, namely through traction on the control means 5.

[0092] In short, preferably, the tilting of said member 4 is controlled in the direction extending in translation from the proximal end 21 towards the distal end 20, in approach of the control means 5 relative to said gripping means 3. Such a movement is highlighted by the positions visible in Figures 4 and 5.

[0093] According to the corresponding embodiment, said gripping means 3 comprise a handle forming a hollow female part. In addition, said handle is crossed by said rod 50, in particular through an opening provided through the wall of said handle.

[0094] As said control means 5 comprise a male part mounted at the opposite end of said rod 50.

[0095] Furthermore, as mentioned previously, said male part is shaped complementary and intended to cooperate within said female part in the deployed position of said member.

[0096] Thus, the rod 50 secured to the male part slides freely within the opening of the female part when the control means 5 are brought together and separated from the gripping means 3.

[0097] According to an alternative embodiment, the control means 5 may comprise a manual actuator, in the form of a trigger or the like, ensuring control of the transition from the retracted position to the deployed position.

[0098] It will be noted that the return to the retracted position can be carried out automatically, through elastic return means, rotating said member 4 around its axis of rotation, or else pushing back or bringing the control means 5 closer to the gripping means 3.

[0099] Furthermore, the holding in the deployed position can be locked by any type of means, in particular by snap-fastening the control means 5 with the gripping means 3, by clipping, by means of a one-way interlocking, for example with teeth and indentations, or in the form of a latch, or by means of an adhesive connecting said means 3, 5 together. Unlocking can be carried out by any type of corresponding means, in particular through a push button, unlocking the snap-fastening or clipping of said means 3, 5.

[0100] In particular, in the corresponding embodiment, the locking and unlocking take place between the male and female parts.

[0101] Furthermore, locking and unlocking is carried out on the part of the device 1 located on the outside, allowing easy access for the practitioner.

[0102] Thus, the gripping means 3, alone or combined with the control means 5, fulfill the function of setting the member 4 in motion. In particular, it is the handle of the gripping means 3 which can be connected to the proximal end 21, to control the change of position of the member 4 located at the distal end 20.

[0103] Relatedly, the device 1 and its components may be made of any type of material, preferably compatible with medical use, such as surgical steel, a composite material and / or a plastic-based material. In particular, the guide(s) 2 and the rod 50, as well as the gripping means 3 and the control means 5 may be made of plastic material, in particular by molding.

[0104] According to one embodiment, the device 1 is provided to facilitate the insertion and extraction of medical instruments.

[0105] Such medical instruments may be, in a non-limiting manner, an endotracheal probe, an endoscopic camera system, one or more measuring sensors, in particular temperature sensors, or even collection or sampling systems, in particular for performing a biopsy.

[0106] To do this, the guide 2 may comprise at least one channel 22, extending superiorly and serving for the longitudinal guidance of the instruments, along said guide 2.

[0107] According to a preferred embodiment, as visible in Figures 12 and 13, said at least one longitudinal guide 2 comprises at least one channel 22 for inserting and extracting medical instruments. Such a channel 22 then gives a longitudinal hollow beam shape to said guide 2, serving as a conductor and allowing medical instruments to slide along this beam, without risking touching the walls of the patient's oral cavity.

[0108] In particular, the guide 2 comprises several collinear channels 22, preferably at least four channels 22, with identical or different internal diameters, allowing the passage of medical instruments with corresponding circumferences. In particular, a wider channel allows the passage of an endotracheal tube or preferably the tube for the intubation of such an endotracheal tube, while channels with smaller diameters allow the passage of instruments, such as probes or endoscopes. In this way, after installation of the device 1, the endotracheal tube can be inserted into the trachea in a simple and reliable manner, through its already correctly positioned tube.

[0109] Opening on the front face, each of the channels 22 allows the practitioner to insert and extract the medical instruments easily and quickly, without having to worry about managing their trajectory, through the guidance along each of said channels 22 of the guide 2.

[0110] Further forward, said at least one insertion and extraction channel 22 extends to a rear end 23 secured to said member 4.

[0111] According to one embodiment, said insertion and extraction channel 22 comprises a flexible rear end 23.

[0112] According to another embodiment, the rear end 23 of said insertion and extraction channel 22 is provided to be articulated.

[0113] Thus, the rear end 23 of the channel 22 can follow the movements of the member 4, as can be seen in particular in the views of [Fig. 14].

[0114] Furthermore, according to one embodiment, the rear end 23 has an outlet orifice 24 inclined or at an angle, according to a slope inclined forward from the member 4 towards the top. The outlet orifice 24 may optionally be slightly flared. This particular shape ensures easier guidance of medical instruments at the outlet, particularly during their extraction.

[0115] Therefore, the possibility of inserting an endoscopic camera system, with a correct and safe installation, separate from other medical instruments, offers the advantage of monitoring the presence of unwanted contents in the cavity of the oropharynx, or even of considering the passage of a probe with an aspirator to eliminate unwanted contents.

[0116] This monitoring makes it possible to check the insertion of an endotracheal tube, guaranteeing its perfect insertion, at any time during the operation.

[0117] Furthermore, the use of the device 1 makes it possible to solve problems related to difficult and complex intubations, for example in the case of complex anatomy of the respiratory tract. The use of the device 1 ensures the insertion of the endotracheal tube exactly up to the entrance of the larynx, while guaranteeing ventilation via the mask 11 and, consequently, oxygenation immediately after the installation of the device 1, even before any possible tracheal intubation. There is then no time limit for the insertion of the endotracheal tube into the trachea, facilitating the task of the practitioner during this manipulation and reducing the stress related thereto.

[0118] Thus, the device 1, with its elongated and flattened shape, allows it to be easily inserted into the oral cavity of a patient. The practitioner grips it from outside the mouth, securely, with a good grip, simply allowing the deployment of the organ 4, in order to push the tongue back to its base and ensure good maintenance of the permeability of the respiratory tract.

[0119] Furthermore, once in place and deployed, the device 1 allows the practitioner to implant related medical instruments, in particular to perform intubation if necessary and pass a tube, a catheter or even a probe. The device 1 can then serve as a guide for the introduction of these instruments, in particular along said guide 2 and the rod 50.

[0120] The invention also relates to a respiratory assistance system 10.

[0121] Such a system 10 is intended to be non-invasive, namely that it allows artificial ventilation to be provided without intubation or penetration of a medical instrument beyond the oral cavity, by using only the circulation occurring naturally from the lungs through the oral cavity and the nasal cavity.

[0122] To do this, the system 10 is of the respiratory mask type and therefore comprises, above, a respiratory mask 11. Such a mask 11 is anatomically shaped to cover at least the nose of a patient's face.

[0123] In particular, the mask 11 has an overall shell shape. Such a shell can be made of any type of material, suitable for the medical field, such as a material plastic or composite.

[0124] The shell shape of said mask 11 allows the rim to rest above the upper lip and on the bridge of the nose, as well as on the cheeks, encompassing this part of the patient's face. Preferably, said mask 11 has dimensions allowing the cheekbones and the sides of the lower jaw area to be covered.

[0125] Furthermore, the mask can be held in position on the patient's head using dedicated means, such as an adjustable strap or at least one elastic band, surrounding the skull, or passing behind the ears, ensuring sufficient tension to apply the mask 11 tightly against the patient's skin.

[0126] According to one embodiment, the circumference of the mask 11 may comprise a peripheral seal 12, made of flexible and / or elastic material, ensuring a sealed contact by pressing said mask 11 against the skin of the face.

[0127] According to one embodiment, the circumference of said mask 11 can be secured and held in place on the patient's face by means of adhesive 120, attached projecting laterally on the circumference of said mask 11, from the peripheral seal(s) 12. Alternatively or additionally, other fixing means can be envisaged to ensure the positioning and holding of the mask 11 on the patient's face, in a hermetic manner.

[0128] Further on, said mask 11 comprises a front face 13 and a through channel 14, intended to be hermetically connected with an artificial ventilation device.

[0129] It will be noted that such an artificial ventilation device may be included in the system 10. This device may be of any type, in particular a dedicated electrical device, such as a mechanical or assisted ventilation device, or even a manually operated balloon. The artificial ventilation device is connected to the mask 11 by tubes or ribbed tubing provided for this purpose, mounted in a sealed fit with said channel 14.

[0130] In addition, the mask 11 also comprises a rear face 130, located opposite the front face 13. This rear face 130 is therefore located on the side of the patient's face.

[0131] According to one embodiment, as seen in Figures 15 and 16, the system provides that said respiratory mask 11 comprises a section 111 provided to be removable, cooperating in a frontally interlocking manner on said mask 11 covering the nose of the patient's face. Such a removable section 111 can therefore be positioned and removed from the mask 11, making it easier to place said mask 11 on the patient's face.

[0132] Furthermore, the fitting of the section 111 on the mask 11 is intended to be hermetic.

[0133] Thus, the mask 11 can be positioned and adjusted on the patient's face before the start of anesthesia, without rushing. Then, the removable section 111 can be positioned to close the mask 11, particularly after the patient has started to be anesthetized, that is to say only when mechanical ventilation takes over from natural ventilation. Such a configuration of the mask 11 makes it possible to create a high concentration of oxygen inhaled by the patient.

[0134] According to one embodiment, said removable section 111 comprises said through channel 14.

[0135] According to one embodiment, in particular when the through channel 14 opens into the removable part 111, the latter comprises an air filter, making it possible to eliminate pathogenic agents and bacteria, reducing the need to intervene at the level of the filter of the artificial ventilation device.

[0136] Advantageously, the system 10 comprises a medical device 1 for maintaining the permeability of the respiratory tract according to one and / or other of the embodiments described previously.

[0137] In addition, the system 10 comprises means for fixing and locking said device 1 when inserted into the mouth of said patient.

[0138] Furthermore, in order to be able to easily manipulate the device 1 and actuate the member 4 between the retracted and deployed positions, said device 1 is mounted passing through between said mask 11 and said fixing and blocking means. In addition, said gripping means 3 and said control means 5 are located on the side of the front face 13 of said mask 11.

[0139] According to one embodiment, said locking and fixing means comprise a compartment 15 with a rear face anatomically shaped to come into contact with and at least partially cover the patient's jaw. Such an anatomical shape is notably visible in [Fig. 10].

[0140] In addition, said compartment 15 is connected below said mask 11 in a removable manner. In other words, said compartment 15 can be positioned on the mask 11 and secured. In this position fixed on the mask 11, the compartment 15 then blocks the device 1 and secures it with said mask 11.

[0141] In particular, according to one embodiment, said compartment 15 can be mounted articulated on said mask 11 between an open position and a closed position, through at least one intermediate position partially open. In the closed position, the device 1 is locked, blocked between the compartment 15 and the bottom of the mask 11.

[0142] Conversely, by removing said compartment 15 or by opening it totally or partially, the device 1 is released and can be introduced or removed from the patient's mouth, or adjusted.

[0143] According to a preferred embodiment, the compartment 15 is mounted in translation relative to said mask 11.

[0144] According to one embodiment, as visible in [Fig.10], said mask 11 can include orifices 110 passing through its lower wall and opening towards the rear of the housing, behind the compartment 15 once fitted. These orifices 110 may in particular be two in number located opposite the nasal orifices, or in the form of a row as visible in [Fig. 16]. Said orifices 110 allow communication between the mouth and the nose, like an anastomosis, once the mask 11 and the compartment 15 are assembled.

[0145] According to one embodiment, these orifices 110 can open onto the front face 13 of the mask 11 and can be connected to a gas supply source 1100, in particular a dioxygen (O2) supply source. Such a supply source 1100 can comprise a tip or cannula, secured to the front face 13 of said mask 11. Thus, the tip or cannula of the supply source 1100 can be connected to a dioxygen supply network, in particular through a catheter. Such a supply source 1100 is notably visible in [Fig. 16].

[0146] According to the corresponding embodiment, when closing the mask 11, the fitting of the removable section 111 closes the orifices 110, in particular in a sealed manner, closing the supply of oxygen.

[0147] According to one embodiment, as visible in [Fig.l 1], the compartment 15 is fixed to said mask 11 by fitting, through complementary shapes and dimensions. In particular, said mask 11 comprises a housing below, within which said compartment 15 is introduced. Said compartment 15 is then mounted and movable inside said housing, preferably sliding in translation.

[0148] Furthermore, said housing is crossed by the device 1, in particular at the level of the guide(s) 2 and the rod 50. Thus, by fitting the compartment 15, at least said rod 50 is sandwiched inside the housing, between the upper wall of the compartment 15 and the lower part of the mask 11.

[0149] In order to guide the compartment 15 during its fitting into the housing, said compartment 15 can be equipped with any type of means. According to one embodiment, as visible in [Fig.l 1], said compartment 15 comprises slides 16, located on either side, of the right and left sides. These slides 16 cooperate within grooves formed in the wall of the mask 11, in particular the internal side walls of said housing. The compartment 15 can thus slide freely from the bottom to the top, during its installation until it comes to pinch and block the device 1, and vice versa for its release.

[0150] It will be noted that when fitted together, in particular in the closed position, the compartment 15 can be locked by any type of means, in particular by snap-fastening or clipping, or even by means of an adhesive.

[0151] According to one embodiment, the system 10 comprises means 150 for maneuvering the compartment 15 between its closed and open positions, preferably from the closed position to the open position.

[0152] Such means 150 for maneuvering the compartment 15 between its closed and open positions may be of any type, preferably in the form of a lever 151. Such a lever 151 is mounted on the front face 13 of the mask 11 in rotation relative to said mask 11, in particular at the level of at least one of the edges of the housing of said mask 11. In particular, the lever 151 is mounted on the mask 11 above the location covering the patient's jaw.

[0153] Therefore, by actuating said lever 151, its rotation induces the translation of the compartment 15, like a cam.

[0154] The direction of actuation towards the opening of the compartment 15 may be clockwise or counterclockwise. In particular, the downward actuation of the lever 151 induces the downward translation of the compartment 15 and its opening.

[0155] The reverse maneuver is also possible, but the closing of compartment 15 can be carried out when the patient's mouth is closed, as will be seen later.

[0156] According to one embodiment, as visible in [Fig.18], the means 150 for maneuvering the compartment 15 comprise a single lever 151, located on one side of the housing of the mask 11. Such a single lever 151 is mounted in rotation relative to a pivot point or a cradle 152.

[0157] According to an alternative embodiment, as visible in figures 19 and 20, the means 150 for maneuvering the compartment 15 comprise a double lever 151, with distal ends connected by a bar 153. Such a double lever 151 is mounted in rotation on each side of the housing of the mask 11.

[0158] Thus, the compartment 15 makes it possible to easily block and maintain the device 1 on the mask 11, without introducing another element inside the oral cavity. This configuration is all the more suitable for the care of patients with a small mouth morphology, in particular for children.

[0159] According to another embodiment, said blocking and fixing means comprise an interdental spacer 17. Such an interdental spacer 17 is anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth.

[0160] According to one embodiment, said interdental spacer 17 comprises an upper part 170 and a lower part 171, connected to each other. By slightly opening the parts 170, 171, it is then possible to move the interdental spacer 17 along the device 1, to adapt to the individual morphological characteristics and anatomy of each patient.

[0161] According to one embodiment, the upper part 170 of the interdental spacer 17 is mounted integrally projecting from the rear face 130 of said mask 11. This upper part 170, integral and static with respect to the mask 11, therefore allows it to be easily positioned in the patient's mouth.

[0162] According to a corresponding embodiment, the lower part 171 of the interdental spacer 17 is integral with said compartment 15 and provided as a projection from its rear face.

[0163] Thus, the mask 11 is positioned with the upper part 170 against the upper jaw of the patient, with the compartment 15 in the released position, namely open but with the lower part 171 positioned against the lower jaw of the patient, who only has to close the mouth to bring the parts 170, 171 of said interdental spacer 17 together, ensuring sufficient pinching to hold the mask 11, while allowing the passage of the device 1 between said parts 170, 171.

[0164] In addition, according to one embodiment, said parts 170, 171 comprise at least one chute 172 for receiving the teeth of said patient. In particular, as visible in [Fig. 2], each chute 172 has a hollow arcuate shape, complementary in size to internally receive the patient's teeth.

[0165] According to a preferred embodiment, each chute 172 comprises a material having elastic characteristics, in particular flexibility, or even shape memory, preferably temporary. In particular, the bottom of one and / or the other of the chutes 172 of one and / or the other of the parts 171, 172 is covered with said elastic material. Such a material makes it possible to bear on the teeth and ensure the blocking of the interdental spacer 17.

[0166] Alternatively, it is the interdental spacer 17 which is entirely made of a flexible and / or elastic material, preferably with shape memory, such as a plastic or composite gel.

[0167] Furthermore, such an interdental spacer 17 can be made of any type of material, suitable for the medical and dental field, preferably made of composite material or plastic-based, or even natural or synthetic rubber. In particular, said interdental spacer 17 can be made by molding the patient's teeth or by a dental impression, ensuring its proper implantation and maintenance in the mouth.

[0168] In addition, said interdental spacer 17 is crossed by said medical device 1, between said organ 4 and said gripping means 3.

[0169] According to the corresponding embodiment, the interdental spacer 17 is crossed by the guide(s) 2 and the rod 50.

[0170] Furthermore, the interdental spacer 17 can be mounted to slide along the guide(s) 2 and the rod 50, making it possible to adjust the length of introduction of said device 1 into the patient's mouth.

[0171] Therefore, it is by closing the patient's mouth that the interdental spacer 17 comes to pinch the device 1, in particular the rod 50, blocking it in the deployed position of said member 4.

[0172] It should be noted that the mouth can be locked in the closed position by any type of means, in particular through a chin strap or a tie, or even an adhesive.

[0173] Thus, the device 1 is blocked and held by the interdental spacer 17, simply by closing the patient's mouth, so that his teeth bite said interdental spacer 17, thus pinching said device 1 to hold it in place. This configuration is all the more suitable for the treatment of patients with a mouth morphology adapted to the insertion of said interdental spacer 17, in particular for adults.

[0174] Such an embodiment may or may not be combined with the embodiment provided with said compartment 15.

[0175] According to one embodiment, said fixing and locking means comprise at least one plate 18 mounted in translation along said longitudinal guide 2. In addition, said guide 2 is provided with notches 19 providing indexed positions for fixing said plate 18. In other words, the notches 19 are positioned and spaced along the guide(s) 2, making it possible to place said plate 18 more or less far away, adapting the length of the part of the device 1 introduced into the mouth, so that the member 4 is positioned as best as possible against the tongue, as close as possible to its base.

[0176] According to a preferred embodiment, the notches 19 are in the form of bars, positioned projecting from the lower face of the guide(s) 2, in particular connecting the two guides 2 together.

[0177] Such a plate 18 with the indexing notches 19 is notably visible in figures 8 and 9.

[0178] According to a preferred embodiment, said fixing and blocking means also comprise a labial support 190 mounted freely in translation along said longitudinal guide 2, between said plate 18 and said member 4.

[0179] Such a lip support 190 may have any shape, in particular a circular or ovoid shape, as seen in Figures 7 to 9.

[0180] Said lip support 190 can be made of any type of material, preferably flexible and / or elastic, such as a composite or plastic-based material, or even a natural or synthetic rubber. This elastic characteristic allows the lip support 190 to slide along the guide(s) 2 and come to bear against the lips. In addition, the elastic material can ensure the locking of the rod 50 relative to the guide 2.

[0181] In addition, said plate 18 comes to bear against an external face of said support 190. labial, when adjusted according to one of said indexed positions. In other words, when putting the device 1 in place, it is introduced into the patient's mouth and the passage from the retracted position to the deployed position of the member 4 is activated. Then, after closing the mouth, the labial support 190 is moved so that its internal face comes to bear against the patient's lips. The plate 18 is then positioned against the external face of said labial support 190, according to a position indexed by the corresponding notch 19. This notch 19 then blocks the plate 18 against the labial support 190, which adheres hermetically to the patient's lips, in particular by deforming locally due to its elastic material.

[0182] Thus, between the plate 18 and the member 4 in the deployed position, the device 1 is engaged in the patient's mouth, enclosed by the lips and the base of the tongue, thus ensuring its support.

[0183] According to a corresponding embodiment, when said at least one longitudinal guide 2 of said medical device 1 comprises at least one channel 22 for inserting and extracting medical instruments, preferably several, then for each of said at least one insertion and extraction channel 22, an orifice is provided passing through opposite said plate 18, as well as possibly said labial support 190. In other words, said plate 18, once in place to hold the device 1 in its deployed position of the member 4, it is possible to introduce and extract the medical instruments via the orifices in alignment with the channels 22.

[0184] Such an embodiment may or may not be combined with one and / or the other of the embodiments provided with said compartment 15 and / or said interdental spacer 17.

[0185] It will be noted that once the system 10 is in place, the sealing of the mouth can be achieved by related means, such as an adhesive affixed to the lips by pinching or sealing using a medical plaster.

[0186] As an example of use of the respiratory assistance system 10, in the context of general anesthesia, once the mask 11 is positioned on the patient's face and connected to the mechanical ventilation device by the channel 14, pre-oxygenation is carried out for one to three minutes. The mask 1 can then be fixed, through the elastic link or else by adhesives.

[0187] The patient is then placed under anesthesia. Since the installation of the device 1 is a relatively painless procedure and moderately irritates the reflexogenic zones, it is possible to limit the application to a superficial level of anesthesia, without the use of narcotic analgesics at this stage, which in most cases preserves natural breathing and considerably reduces the risk of developing hypoxia or hypercapnia.

[0188] Having reached a level of anesthesia which suppresses consciousness, nausea and swallowing reflexes, ensuring sufficient relaxation of the muscles of the oropharynx, the patient's mouth is opened to introduce the device 1, with organ 4 in the retracted position. The spatula is placed behind the tongue, similar to the introduction of an anesthesiological laryngoscope.

[0189] Once in place, the control means 5 are actuated in order to bring the gripping means 3 closer together, generating the tilting of the member 4, which presses against the root of the tongue and the epiglottis, in the position for opening the respiratory tract.

[0190] The device 1 is then blocked and fixed, according to the elements corresponding to the aforementioned embodiments. If necessary, the mouth is made airtight.

[0191] Full respiratory assistance is then provided and it is possible to deepen the anesthesia, use inhalation anesthetics and administer muscle relaxants.

[0192] According to one use of the corresponding embodiments, the mask 11 without its removable section 111 is positioned on the face of a patient, with the compartment 15 open. The patient then closes his mouth, to clench his teeth and bite into the interdental spacer 17 and thus bring the lower part 171 closer to the static and integral upper part 170 of the mask 11. The latter is then secured in place on the patient's face, applying the peripheral seals 12 and the adhesives 120 hermetically against the patient's skin.

[0193] Next, the patient is placed under anesthesia and, using the lever 151, the compartment 15 is opened, pushing the patient's lower jaw downwards, to implant the device 1, as previously described. The compartment 15 is then closed, securing said device 1.

[0194] Finally, the removable section 111 is replaced on the mask 11 and mechanical ventilation begins.

[0195] In addition, before placing the patient under anesthesia, once the mask 11 is in place, the supply of oxygen can be provided, in particular at a suitable respiratory concentration. The oxygen supplied from the source 1100 exits through the orifices 110, in particular in the form of a curtain when the orifices 110 form a row. As mentioned previously, when the removable section 111 is positioned, this supply is then closed by blocking the orifices 110.

[0196] In the hands of an experienced operator, such a procedure for implanting the device 1 and the system 10 takes a few seconds, which, combined with probably preserved spontaneous breathing, considerably reduces the risk of developing hypoxia and hypercapnia.

[0197] Thus, the respiratory assistance system 10, combined with fixing and blocking of the device 1 for maintaining the permeability of the respiratory tract, ensures implantation without risk of damaging the mucous membranes or the internal walls, without trauma. Once in place, the device 1 is blocked, without risk of displacement. untimely, especially if the patient has to be moved or transported. This system 10 and its device 1 can be used during emergency interventions, as well as for medical operations requiring anesthesia. Finally, the system 10 offers natural ventilation, using physiological airways, without resorting to intubation. In addition, an advantage of the system 10 and the device 1 lies in the adaptation and faster medical recovery of the patient to completely independent breathing, once the anesthesia is over.

[0198] Furthermore, the device 1, coupled or not to the system 10, makes it possible to modify current anesthesia techniques, in particular requiring tracheal intubation, as is the case in a large number of surgeries, in particular major abdominal surgeries, including for esophageal and gastric interventions, in particular for the treatment of obesity.

[0199] In particular, it is possible to perform and maintain intubation during anesthesia and part of the surgery, then to proceed with extubation immediately after the end of the main stage of the surgery, then to apply respiratory assistance almost simultaneously, through the mask 11 of the respiratory assistance ventilation system 10. Such a procedure makes it possible to limit the tracheal intubation time, thereby facilitating the return to spontaneous breathing of the patient.

Claims

1.

2. Claims Non-invasive respiratory assistance system (10), of the respiratory mask type, comprising - above, a respiratory mask (11), anatomically shaped to cover at least the nose of a patient's face, said mask (11) comprising a front face (13) and a through channel (14), intended to be hermetically connected with an artificial ventilation device; - a medical device (1) for maintaining the patency of the respiratory tract comprising - at least one longitudinal guide (2) extending along a curved path; - gripping means (3) connected to a proximal end (21) of said longitudinal guide (2); - at least one member (4) mounted at a distal end (20) of said longitudinal guide (2), said organ (4) comprising a spatula shaped complementary to the lingual anatomy, said member (4) being movable in displacement relative to said longitudinal guide (2) from a retracted position to a deployed position, and vice versa, i) in the retracted position, the spatula of said member (4) extends along said trajectory of said longitudinal guide (2) ii) in the deployed position, said member (4) extends downwardly projecting relative to said longitudinal guide (2); said medical device (1) further comprising mounted at said proximal end, means (5) for controlling the movement of said organ (4) between the retracted and deployed positions; characterized in that said system (10) comprises - means for fixing and locking said device (1) when inserted into the mouth of said patient; - said device (1) being mounted through between said mask (11) and said fixing and blocking means, said gripping means (3) and said control means (5) being located on the side of the front face (13) of said mask (11).

2. System (10) according to the preceding claim, characterized in that said blocking and fixing means comprise - a compartment (15) with a rear face anatomically shaped to rest on and at least partially cover the patient's jaw; said compartment (15) being connected at the bottom to said mask (11) in a removable manner.

3. System (10) according to claim 1 or 2, characterized in that - said blocking and fixing means comprise an interdental spacer (17), anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth, with an upper part (170) and a lower part (171), said interdental spacer (17) being crossed by said medical device (1), between said organ (4) and said gripping means (3).

4. System (10) according to claim 3, characterized in that - the upper part (170) of the interdental spacer (17) is mounted integrally projecting from a rear face (130) of said mask (11).

5. System (10) according to the preceding claim, characterized in that - said lower part (171) of the interdental spacer (17) is integral with said compartment (15) and provided projecting from its rear face.

6. System (10) according to any one of claims 1 to 5, characterized in that - said respiratory mask (11) comprises a removable section (111), cooperating in a frontally fitted manner on said mask (11) covering the nose of the patient's face.

7. System (10) according to the preceding claim, characterized in that - said removable section (111) comprises said through channel (14).

8. System (10) according to any one of claims 2 to 7, characterized in that - said compartment (15) is mounted articulated on said mask (11) between an open position and a closed position, in particular according to a translation.

9. System (10) according to the preceding claim, characterized in that it comprises - means (150) for maneuvering the compartment (15) between a closed position and an open position, preferably from the closed position to the open position, in particular in translation.

10. System (10) according to the preceding claim, characterized in that - said means (150) for maneuvering the compartment (15) comprise at least one lever (151) mounted on the front face (13) of the rotating mask (11) inducing the translation of compartment 15.

11. System (10) according to any one of the preceding claims, characterized in that - said at least one longitudinal guide (2) of said medical device (1) comprises at least one channel (22) for insertion and extraction of medical instruments.

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