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, at the top, 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 a mechanical ventilation device, and a medical device (1) for maintaining airway patency, comprising a longitudinal guide (2); grasping means (3) and a component (4) comprising a spatula; said system (10) comprising means for fixing and locking said device (1) in insertion within the mouth of said patient; said device (1) being mounted through-hole between said mask (11) and said fixing and locking means, said grasping 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: Intended non-invasive respiratory support 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] It is known that during the medical care and treatment of a patient experiencing respiratory distress or failure, as well as during surgery involving general anesthesia or anesthesia of anatomical structures essential for the proper functioning of the respiratory tract, it is necessary to provide respiratory support to the patient. This respiratory support simulates the biological function of respiration and ensures gas exchange for the entire duration of the period during which the natural functioning of the respiratory tract is impaired.

[0003] Further, the implementation of respiratory assistance can be carried out in an invasive manner, 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 carried out in a non-invasive manner, 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 responders and medical personnel during an emergency intervention, commonly using a bag-mask type insufflator with a valve or "BVM" (for "Self-Filling Bag with One-Way Valve").

[0006] During a planned surgical procedure, respiratory assistance is generally provided 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 a non-invasive respiratory assistance device, 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, particularly in the case of anesthesia. Indeed, trauma or unconsciousness causes a decrease or loss of muscle tone, which can lead to airway obstruction through a blockage of the airway entrance. from the larynx via the epiglottis and the root of the tongue.

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

[0010] The invention further relates to a medical device for maintaining the permeability of the airways, 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. The intubation probe is known, but it has major drawbacks, such as the traumatic and complex implantation of the intubation probe tube.

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

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

[0014] The invention aims to overcome the drawbacks of the prior art by providing a respiratory assistance system in the form of a mask combined with a medical device for maintaining airway patency, 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 reflex zones of the trachea and larynx, which facilitates its implantation and removal, reducing the risk of trauma.

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

[0016] In addition, the assistance system provides elements to allow the device to be positioned and maintained, facilitating this operation and the steps of anesthesia for the patient.

[0017] To this end, the invention relates to a non-invasive respiratory support system, of the respiratory mask type. Such a system is specifically designed for medical devices to maintain airway patency.

[0018] According to the invention, such a system comprises - at the highest level, 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 the patency of the airways including - at least one longitudinal guide (2) extending along a curved trajectory; - gripping means (3) connected to a proximal end (21) of said longitudinal guide (2); - at least one component (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 an extended 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 deployed position, said organ (4) extends downwards in projection 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 includes - means of 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 locking means, said gripping means and said control means being located on the front face side of said mask.

[0020] According to additional, non-limiting features, said blocking and fixing means comprise a compartment with a rear face anatomically shaped to support and at least partially cover the patient's jaw; said compartment being connected below to 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 dentition, with an upper part and an inferior part, said interdental spacer being traversed by said medical device, between said organ and said grasping means.

[0022] According to one embodiment, the upper part of the interdental spacer is mounted securely in projection 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 projecting from its rear face.

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

[0025] According to one embodiment, said respiratory mask includes a removable section, cooperating by fitting frontally onto said mask covering the nose of the patient's face.

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

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

[0028] According to one embodiment, said means for maneuvering the compartment include 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 includes at least one channel for the insertion and extraction of medical instruments. Presentation of the drawings

[0030] Other features and advantages of the invention will become apparent from the following detailed description of non-limiting embodiments of the invention, with reference to the accompanying figures, in which:

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

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

[0033] [Fig.3] schematically represents a profile view of one 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 a retracted position in 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, providing support to maintain the base of the language;

[0037] [Fig.7] schematically represents a top perspective view 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 labial support;

[0040] [Fig. 10] schematically represents a top rear perspective view of a third embodiment of the system, equipped with means for locking the medical device, in the form of a compartment cooperating below in interlocking 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 onto the lower part of said mask;

[0042] [Fig. 12] schematically represents a profile view of another embodiment of the medical device, in a retracted position and equipped with a longitudinal guide forming a channel for the insertion and extraction of 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 along a vertical section of the implementation of the medical device introduced into the patient's oral cavity, 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 displacement 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 a position to be fitted onto 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 an initial configuration of the means to maneuver 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 implementation of the system, in the open position of the compartment, with a second configuration of the means to maneuver 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 airways, 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, device 1 is intended to free up circulation along the airways and maintain this circulation, by pressing against the base or root of the tongue to push it forward, namely towards the frontal or anterior anatomical part of the patient's skull).

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

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

[0055] Furthermore, the length of the guide 2 is sufficient to allow the insertion of its distal end 20 into the throat of a patient, near the root of the patient's tongue, while keeping 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 to the root of the tongue, but also allowing the portion of the guide 2 inserted into the oral cavity to be adapted to the size of the latter.

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

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

[0058] Further, the device 1 includes 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 portion. This female portion can be of any shape, preferably in the form of a half-tube, open at 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 grasping the device 1, ensuring a firm grip.

[0060] According to the embodiments shown in the figures, said handle extends orthogonally or essentially orthogonally with respect 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 seen in figures 12 to 14, the handle extends under the guide 2.

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

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

[0064] Advantageously, device 1 is designed to press on the base of the tongue, in order to push it forward, keeping the airways open.

[0065] To do this, said organ 4 is mobile 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 organ 4 extends along said trajectory of said longitudinal guide 2. In other words, said spatula extends in line with the guide 2, allowing the insertion and extraction of the device 1 within the cavity oral, until said spatula reaches the base of the tongue. Such a retracted position during insertion of device 1 within an oral cavity is shown in [Fig.5].

[0067] In the deployed position, said organ 4 extends inferiorly in projection relative to said longitudinal guide 2. In other words, organ 4 forms an angle with respect to said trajectory at the distal end 20, so as to press against the base of the tongue. Such a deployed position of organ 4 to repel the tongue by pressing against its base is shown in [Fig. 6].

[0068] In addition, the transition from one position to another, as well as maintaining the organ 4 in the deployed position, is ensured by the practitioner taking hold of the grasping means 3.

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

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

[0071] Thus, the male part of the control means 5 can insert into the female part of the gripping means 3 during actuation to move the organ 4 from the retracted position to the deployed position, and can withdraw during the movement from the deployed position to the retracted position (or vice versa). In short, moving the control means 5 closer to or further away from the gripping means 3 allows the organ 4 to be actuated between its deployed and retracted positions. Figure 4 shows, in particular, a movement of the control means 5 closer to the gripping means 3, actuating the deployment of the organ 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 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 The parts may be removable from rod 50 and / or guide 2, allowing them to be removed once device 1 is in place. This removable feature also makes these parts easier to clean.

[0074] Regarding 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. Furthermore, 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 occurs by rotating clockwise, while the return to the retracted position occurs by rotating counterclockwise.

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

[0076] According to one embodiment, the organ 4 is mounted in rotation through first rings 6, secured with 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 organ 4, or vice versa.

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

[0079] According to yet another embodiment, the organ 4 can be mounted on the distal end 20 through an elastic joint, in particular made of a material allowing its bending or curvature relative to the guide 2, such as natural or synthetic rubber.

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

[0081] To do this, according to one embodiment, as seen 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 connection, or even flexible, 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 lever.

[0083] According to one embodiment, the component 4 is mounted for rotation through second rings 7, secured with 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 organ 4, or vice versa.

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

[0086] Furthermore, 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 gap 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 guides.

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

[0088] According to one embodiment, like 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 the extension for the activation of the organ 4 towards the deployed position (or towards the retracted position), or conversely during its contraction (or vice versa 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 organ 4 from the retracted position to the deployed position. In particular, the translational movement from front to back of the device 1 (i.e., from the frontal or anterior part of the skull to the posterior part) actuates the rotation of said organ 4 towards the deployed position, namely during a push on the control means 5.

[0091] Conversely, 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 towards the retracted position, namely through a pull on the control means 5.

[0092] In summary, preferably, the tilting of said organ 4 is controlled in the direction extending by a translation from the proximal end 21 to the distal end 20, bringing the control means 5 closer to said gripping means 3. Such a displacement is demonstrated 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 portion. Furthermore, said handle is traversed by said rod 50, in particular through a through opening provided within 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 complementaryly and intended to cooperate within said female part in the deployed position of said organ.

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

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

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

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

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

[0101] In addition, the 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 grasping means 3, alone or combined with the control means 5, fulfill the function of setting the organ 4 in motion. In particular, it is the handle of the grasping means 3 that can be connected to the proximal end 21, to control the change of position of the organ 4 located at the distal end 20.

[0103] Relatedly, the device 1 and its components can 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, can be made of plastic material, notably by molding.

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

[0105] Such medical instruments may include, but are not limited to, an endotracheal probe, an endoscopic camera system, one or more measurement sensors, in particular for temperature, or sampling or collection systems, in particular for performing a biopsy.

[0106] To do this, the guide 2 may include 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 shown in Figures 12 and 13, said at least one longitudinal guide 2 comprises at least one channel 22 for the insertion and extraction of medical instruments. Such a channel 22 then gives said guide 2 a longitudinal hollow beam shape, serving as a conductor and allowing medical instruments to slide along this beam without risk of contacting 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 larger channel allows the passage of an endotracheal tube or, preferably, the tube for intubating such an endotracheal tube, while channels of smaller diameters allow the passage of instruments, such as probes or endoscopes. In this way, after the installation of the device 1, the endotracheal tube can be inserted into the trachea simply and reliably, through its already correctly positioned tube.

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

[0110] Further on, said at least one insertion and extraction channel 22 extends to a rear end 23 integral with said organ 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 articulated.

[0113] Thus, the rear end 23 of the canal 22 can follow the movements of the organ 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 inclined or angled outlet 24, with a slope inclined forward from the member 4 towards The top. The outlet 24 may optionally be slightly flared. This particular shape facilitates the guidance of medical instruments during their ejection, especially during their extraction.

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

[0116] This monitoring allows verification of the insertion of an endotracheal tube, ensuring its perfect insertion, at any time during the operation.

[0117] Furthermore, the use of device 1 makes it possible to resolve problems associated with difficult and complex intubations, for example, in the case of complex airway anatomy. Using device 1 ensures that the endotracheal tube is inserted precisely to the entrance of the larynx, while simultaneously guaranteeing ventilation via mask 11 and, consequently, oxygenation immediately after the device 1 is inserted, even before any tracheal intubation is performed. There is therefore no time limit for inserting the endotracheal tube into the trachea, thus facilitating the practitioner's task during this procedure and reducing the associated stress.

[0118] Thus, the device 1, with its elongated and flattened shape, allows for easy insertion into a patient's oral cavity. The practitioner grasps it securely from outside the mouth, with a good grip, simply allowing the organ 4 to be deployed in order to push the tongue back to its base and ensure proper maintenance of airway patency.

[0119] Furthermore, once in place and deployed, the device 1 allows the practitioner to implant related medical instruments, including performing intubation if necessary and passing a tube, catheter, or probe. The device 1 can then serve as a guide for the introduction of these instruments, particularly along the 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, using only the circulation that occurs naturally from the lungs through the oral cavity and the nasal cavity.

[0122] To this end, the system 10 is of the respiratory mask type and therefore includes, at the top, 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 perimeter 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 enabling it to cover the cheekbones and the sides of the lower jaw area.

[0125] In addition, the mask can be kept in position on the patient's head by means of dedicated means, such as an adjustable strap or at least an elastic band, around 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 mask 11 surround may include a peripheral seal 12, made of flexible and / or elastic material, ensuring a tight seal when the mask 11 is pressed against the skin of the face.

[0127] According to one embodiment, the edge of said mask 11 can be secured and held in place on the patient's face by means of adhesive 120, projecting laterally around the perimeter of said mask 11 from the peripheral seal(s) 12. Alternatively or in addition, other fastening means can be considered to ensure the positioning and securement of the mask 11 on the patient's face in an airtight manner.

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

[0129] It should be noted that such an artificial ventilation device may be included in the system 10. This device may be of any type, including a dedicated electrical device, such as a mechanical or assisted ventilation device, or even a manually operated bag. The artificial ventilation device is connected to the mask 11 by grooved tubes or tubing provided for this purpose, fitted in a tight seal with said channel 14.

[0130] In addition, the mask 11 also includes 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 shown in Figures 15 and 16, the system provides that said respiratory mask 11 includes a removable section 111, which fits frontally onto 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] In addition, the fitting of section 111 onto mask 11 is provided to be airtight.

[0133] Thus, the mask 11 can be positioned and adjusted on the patient's face before the onset of anesthesia, without rushing. Then, the removable section 111 can be positioned to close the mask 11, particularly after the patient has begun to be anesthetized, that is, only when mechanical ventilation takes over from natural ventilation. Such a configuration of 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 includes said through channel 14.

[0135] According to one embodiment, in particular when the through channel 14 opens into the removable part 111, the latter includes an air filter, allowing the elimination of pathogens and bacteria, reducing the need to intervene at the level of the filter of the artificial ventilation device.

[0136] Advantageously, the system 10 includes a medical device 1 for maintaining the permeability of the airways according to one and / or the other of the embodiments described above.

[0137] Furthermore, the system 10 includes means for fixing and locking said device 1 in insertion within the mouth of said patient.

[0138] Furthermore, in order to easily manipulate the device 1 and actuate the component 4 between the retracted and deployed positions, said device 1 is mounted through the mask 11 and said fastening and locking means. Moreover, said gripping means 3 and said control means 5 are located on the front face 13 of said mask 11.

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

[0140] Furthermore, said compartment 15 is removably connected below said mask 11. In other words, said compartment 15 can be positioned on the mask 11 and secured. In this position, attached to the mask 11, the compartment 15 then locks the device 1 and secures it to said mask 11.

[0141] In particular, according to one embodiment, said compartment 15 can be hinged on said mask 11 between an open position and a closed position, via at least one intermediate partially open position. 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 inserted into or removed from the patient's mouth, or adjusted.

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

[0144] According to one embodiment, as seen in [Fig. 10], said mask 11 may comprising openings 110 through its lower wall and opening towards the rear of the housing, behind the compartment 15 once it is fitted. These openings 110 may be, in particular, two in number, located opposite the nasal openings, or arranged in a row as shown in [Fig. 16]. These openings 110 allow communication between the mouth and the nose, similar to 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 an oxygen (O2) supply source. Such a supply source 1100 may include a nozzle or cannula attached to the front face 13 of said mask 11. Thus, the nozzle or cannula of the supply source 1100 can be connected to an oxygen supply network, in particular via a catheter. Such a supply source 1100 is notably visible in [Fig. 16].

[0146] According to the corresponding embodiment, when the mask 11 is closed, the fitting of the removable section 111 closes the orifices 110, in particular in a tight manner, blocking the supply of dioxygen.

[0147] According to one embodiment, as shown in [Fig. 11], the compartment 15 is attached to the mask 11 by interlocking, through complementary shapes and dimensions. In particular, the mask 11 includes a lower recess into which the compartment 15 is inserted. The compartment 15 is then mounted and movable within the recess, preferably sliding along a translational path.

[0148] In addition, said housing is traversed by the device 1, in particular at the level of the guide(s) 2 and the rod 50. Thus, when 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] To guide the compartment 15 during its insertion into the housing, said compartment 15 can be equipped with any type of means. According to one embodiment, as shown in [Fig. 11], said compartment 15 comprises slides 16, located on either side, on 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 bottom to top during its insertion until it pinches and locks the device 1, and vice versa for its release.

[0150] It should be noted that when fitted, particularly in the closed position, compartment 15 can be locked by any type of means, including snap-fit ​​or clip-fit, or even by means of an adhesive.

[0151] According to one embodiment, the system 10 includes 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 can 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 with respect 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 compartment 15, like a cam.

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

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

[0156] According to one embodiment, as seen 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 for rotation about a pivot point or a cradle 152.

[0157] According to an alternative embodiment, as seen 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 rotatably mounted on each side of the housing of the mask 11.

[0158] Thus, compartment 15 makes it easy to lock and hold device 1 onto mask 11, without introducing any other element into the oral cavity. This configuration is particularly suitable for treating patients with small mouth morphology, especially children.

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

[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 securely in projection from the rear face 130 of said mask 11. This upper part 170, which is fixed and static in relation 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 is projecting 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, i.e. open but with the lower part 171 positioned against the lower jaw of the patient, who only has to close his mouth to bring the parts 170,171 of said interdental spacer 17 closer together, ensuring sufficient pinching to hold the mask 11, while allowing the passage of the device 1 between said parts 170,171.

[0164] Furthermore, according to one embodiment, said parts 170, 171 comprise at least one groove 172 for receiving the patient's teeth. In particular, as can be seen in [Fig. 2], each groove 172 has a hollow, arc-shaped form, dimensioned to receive the patient's teeth internally.

[0165] According to a preferred embodiment, each groove 172 comprises a material having elastic properties, in particular flexibility, or even shape memory, preferably temporary. In particular, the bottom of one and / or the other of the grooves 172 of one and / or the other of the parts 171, 172 is covered with said elastic material. Such a material allows it to bear against the teeth and ensure the locking of the interdental spacer 17.

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

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

[0168] Furthermore, said interdental spacer 17 is traversed by said medical device 1, between said organ 4 and said grasping means 3.

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

[0170] In addition, the interdental spacer 17 can be mounted to slide along the guide(s) 2 and the rod 50, allowing adjustment of the length of insertion of said device 1 into the patient's mouth.

[0171] Therefore, it is by closing the patient's mouth that the interdental spacer 17 pinches the device 1, in particular the rod 50, locking it in the deployed position of said organ 4.

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

[0173] Thus, the device 1 is blocked and held in place by the interdental spacer 17 simply by closing the patient's mouth, so that their teeth bite down on the interdental spacer 17, thereby pinching the device 1 to hold it in place. This configuration is particularly well-suited for treating patients with a mouth morphology adapted to the insertion of the interdental spacer 17, especially 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 fixing positions for said plate 18. In other words, the notches 19 are positioned and spaced along the guide(s) 2, allowing said plate 18 to be placed closer or further away, adapting the length of the part of the device 1 inserted into the mouth, so that the organ 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 or guides 2, in particular connecting the two guides 2 together.

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

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

[0179] Such a labial support 190 may have any shape, including 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 natural or synthetic rubber. This elastic characteristic allows the lip support 190 to slide along the guide(s) 2 and come into contact with the lips. In addition, the elastic material can ensure that the stem 50 is locked in place relative to the guide 2.

[0181] Furthermore, said plate 18 rests against an external face of said support 190 labial, during adjustment according to one of the indexed positions. In other words, when fitting the device 1, it is inserted into the patient's mouth and the passage from the retracted to the deployed position of the organ 4 is activated. Then, after closing the mouth, the labial support 190 is moved so that its inner face rests against the patient's lips. The plate 18 is then positioned against the outer face of the labial support 190, according to a position indexed by the corresponding notch 19. This notch 19 then locks the plate 18 against the labial support 190, which adheres tightly to the patient's lips, notably by deforming locally due to its elastic material.

[0182] Thus, between the plate 18 and the organ 4 in the deployed position, the device 1 is found to be in contact with the patient's mouth, in contact with the lips and the base of the tongue, thus ensuring its retention.

[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 the insertion and extraction of medical instruments, preferably several, then for each of said at least one insertion and extraction channel 22, a through orifice is provided opposite said plate 18, as well as optionally said labial support 190. In other words, once said plate 18 is in place to maintain the device 1 in its deployed position on the organ 4, it is possible to insert and extract medical instruments via the orifices aligned with the channels 22.

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

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

[0186] As an example of the use of the respiratory support system 10 during general anesthesia, once the mask 11 is positioned on the patient's face and connected to the mechanical ventilation device via channel 14, preoxygenation is performed for one to three minutes. The mask 1 can then be secured using the elastic band or adhesive strips.

[0187] The patient is then placed under anesthesia. Since the installation of device 1 is a relatively painless procedure and moderately irritates the reflexogenic areas, a superficial level of anesthesia can be used, without the need for 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 that suppresses consciousness, the gag reflex, and the swallowing reflex, ensuring sufficient relaxation of the oropharyngeal muscles, the patient's mouth is opened to introduce device 1, with Organ 4 is in a retracted position. The spatula is placed behind the tongue, similar to the introduction of an anesthetic laryngoscope.

[0189] Once in place, the control means 5 are actuated in approach to the grasping means 3, generating the tilting of the organ 4, which comes to press against the root of the tongue and the epiglottis, in the position of opening the respiratory tract.

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

[0191] Complete respiratory support is then provided and it is possible to deepen the anesthesia, use inhaled 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 patient's face, with the compartment 15 open. The patient then closes their mouth, clenches their teeth, and bites into the interdental spacer 17, thus bringing the lower part 171 closer to the static upper part 170 of the mask 11. The mask 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 lever 151, compartment 15 is opened, pushing the patient's lower jaw downwards to implant device 1, as previously described. Compartment 15 is then closed, securing device 1.

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

[0195] Additionally, before placing the patient under anesthesia, once the mask 11 is in place, oxygen can be supplied, notably at an appropriate respiratory concentration. The oxygen supplied from the source 1100 exits through the orifices 110, particularly in the form of a curtain when the orifices 110 are arranged in a row. As mentioned previously, when the removable section 111 is positioned, this supply is then closed by plugging the orifices 110.

[0196] In the hands of an experienced operator, such a procedure for implanting device 1 and 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 in its fixation and locking of the airway patency maintenance device 1, ensures implantation without risk of damage to the mucous membranes or internal walls, and without trauma. Once in place, the device 1 is locked, without risk of displacement. This system, System 10, and its accompanying device, can be used in emergency situations as well as for medical procedures requiring anesthesia. System 10 provides natural ventilation, utilizing the patient's natural airways without the need for intubation. Furthermore, an advantage of System 10 and Device 1 is the patient's faster adaptation and recovery to fully independent breathing once anesthesia has worn off.

[0198] In addition, device 1, coupled or not to system 10, makes it possible to modify current anesthesia techniques, in particular those 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 proceed with extubation immediately after the completion of the main surgical stage, and then apply respiratory support almost simultaneously, through the mask 11 of the respiratory support ventilation system 10. Such a procedure makes it possible to limit the time of tracheal intubation, thereby facilitating the patient's return to spontaneous breathing.

Claims

1.

2. Demands Non-invasive respiratory support 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 airways comprising - at least one longitudinal guide (2) extending along a curved trajectory; - gripping means (3) connected to a proximal end (21) of said longitudinal guide (2); - at least one component (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 organ (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 component (4) extends along said longitudinal path of said guide (2) ii) in deployed position, said organ (4) extends downwards in projection 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 of fixing and locking said device (1) in insertion within 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).

2. System (10) according to the preceding claim, characterized in that said locking and fastening means comprise - a compartment (15) with a rear face shaped anatomically to support and at least partially cover the patient's jaw; said compartment (15) being connected below 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 dentition, with an upper part (170) and an inferior part (171), said interdental spacer (17) being traversed by said medical device (1), between said organ (4) and said grasping means (3).

4. System (10) according to claim 3, characterized in that - the upper part (170) of the interdental spacer (17) is mounted securely in projection 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 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 by frontally fitting onto 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 channel (14) through.

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

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