Non-invasive respiratory assist system including a medical device for maintaining patency of an airway

Abstract

The present invention relates to a non-invasive respiratory support system (10) comprising: a breathing mask (11) at the top, the breathing mask being anatomically shaped to at least cover the nose of a patient’s face, the mask (11) including a front (13) and a through passage (14) intended to be airtightly connected to an artificial ventilation device; and a medical device (1) for maintaining airway permeability and comprising: a longitudinal guide (2); a clamping member (3); and a member (4) including a tongue depressor; the system (10) includes components for securing and locking the device (1) inserted into the patient’s mouth; the device (1) is mounted to pass between the mask (11) and the securing and locking member, the clamping member (3) and the control member (5) being positioned toward the front (13) of the mask (11).

Description

Technical Field

[0001] This invention belongs to the medical field of respiratory assistance and artificial ventilation, especially during general anesthesia.

[0002] It is well known that respiratory assistance is necessary for patients during medical care and treatment, in cases of respiratory distress or failure, and during surgical procedures involving general anesthesia or anesthesia of anatomical parts that regulate the normal function of the airway. This respiratory assistance system mimics the biological function of breathing and ensures gas exchange during periods when the airway is no longer able to function naturally.

[0003] More specifically, respiratory assistance can be provided invasively through intubation or tracheotomy, for example by delivering air directly into the patient's trachea through a tube.

[0004] Breathing assistance can also be provided non-invasively by applying a breathing mask to the patient's face and providing artificial ventilation only through the openings and cavities of the upper airway (that is, the mouth and nose).

[0005] In addition, breathing assistance can be provided manually, typically by first responders and medical personnel in emergency situations using a bag valve mask (BVM).

[0006] During a planned surgical procedure, breathing assistance is typically provided mechanically by connecting specialized equipment, such as a ventilator or mechanical ventilation, to a tube or mask.

[0007] The present invention specifically relates to a type of breathing mask intended for non-invasive breathing assistance.

[0008] In such cases, maintaining airway permeability and respiratory function at the required levels is one of the fundamental tasks during medical procedures, especially under anesthesia. Trauma or loss of consciousness can lead to decreased or lost muscle tone, which can obstruct the airway by blocking the entrance to the larynx via the epiglottis and the base of the tongue.

[0009] Therefore, it is necessary to clean the airways and keep them open.

[0010] The present invention also relates to a medical device for maintaining airway permeability, which is preferably combined with a non-invasive respiratory support system, such as a breathing mask. Background Technology

[0011] Many existing systems attempt to address this problem. Intubation probes are known, but they have major drawbacks, such as the invasiveness of the tube and the complexity of implantation.

[0012] It is also known that the laryngeal mask is prone to displacement or misalignment, which can lead to destructive air leaks.

[0013] Furthermore, such devices often include tubes that connect them to the ventilation equipment, making them lack physiological and natural for the patient and even causing trauma.

[0014] An example of a device for maintaining airway permeability is described in document US5024218. This device includes a longitudinal guide having a curved end and opposing external ends. The curved end is designed for insertion into a patient's mouth and is shaped to compress the base of the tongue. The opposing external ends are provided with clamping components. Furthermore, the opposing ends include a spacer located above the guide to act as a support against the patient's jaw and keep the mouth open. Additionally, the top surface of the guide has a protrusion for guiding a medical device, such as a tube or probe, into the larynx. Summary of the Invention

[0015] The object of this invention is to overcome the shortcomings of the prior art by providing a respiratory support system in the form of a mask combined with a medical device for maintaining airway permeability, which is tubeless and acts on the natural cavities used for breathing. Specifically, the device is restricted to acting on the base of the tongue and the associated epiglottis, thereby avoiding reflex areas of the trachea and larynx, which facilitates its implantation and withdrawal, thus reducing the risk of trauma.

[0016] In short, the device keeps the tongue pulled forward, thereby clearing the airway and ensuring the patient can breathe. In this way, the invention allows for non-invasive ventilation during anesthesia and non-traumatic endotracheal intubation.

[0017] In addition, the assistive system provides elements for positioning and holding the device, thereby facilitating the operation and anesthesia procedure for the patient.

[0018] Therefore, the present invention relates to a non-invasive respiratory support system, such as a breathing mask. This system is specifically designed for medical devices used to maintain airway permeability.

[0019] According to the present invention, such a system includes: - The breathing mask at the top is anatomically shaped to at least cover the patient's nose. The mask includes a front and a through-hole designed for airtight connection to an artificial ventilation device; - A medical device for maintaining airway permeability and comprising: - At least one longitudinal guide extending along a curved path; - A clamping component, which is connected to the proximal end of the longitudinal guide; - At least one component, which is mounted at the distal end of the longitudinal guide. The component includes a tongue depressor that is shaped to complement the anatomical structure of the tongue. The component can be moved relative to the longitudinal guide from a retracted position to an extended position and vice versa. i) In the retracted position, the depressor plate of the member extends along the path of the longitudinal guide; ii) In the deployed position, the member protrudes downward relative to the longitudinal guide; The medical device also includes a component mounted at the proximal end for controlling the displacement of the component between a retracted position and an extended position.

[0020] The system includes: - Components for securing and locking the device inserted into the patient's mouth; The device is mounted to pass between the face mask and the fixing and locking components, with the clamping components and the control components positioned facing the front of the face mask.

[0021] According to another non-limiting feature, the locking and securing component includes an interdental spacer anatomically shaped to abut against the patient's dentition below and / or above, the interdental spacer having an upper portion and a lower portion, the medical device passing through the interdental spacer between the component and the clamping component.

[0022] According to one embodiment, the interdental spacer includes an inflatable internal portion designed to hold a medical device in the patient's mouth.

[0023] According to one embodiment, the interdental spacer includes an inflatable internal portion designed to hold a medical device in the patient's mouth.

[0024] According to one embodiment, the interdental spacer includes a latch that is vertically movably mounted on a support member connected to the spacer via a sleeve, the latch engaging with a notch disposed within the at least one guide member.

[0025] According to one embodiment, the breathing mask includes a removable section that is fitted in front of the mask to cover the nose of the patient's face.

[0026] Preferably, the removable section includes the through passage.

[0027] According to one embodiment, the at least one longitudinal guide of the medical device includes at least one insertion and extraction channel for the medical device.

[0028] According to one embodiment, a medical device includes a clamping member and extends longitudinally within the at least one channel to allow the member to move between a retracted position and an extended position.

[0029] According to one embodiment, at least one guide channel of the medical device passes through the member, with the entrance of the guide channel aligned with the exit of the at least one channel. Attached Figure Description

[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 drawings, in which: Figure 1 A front perspective view of one embodiment of a respiratory support system is schematically shown, wherein a locking component in the form of an interdental spacer is used to secure a medical device for maintaining airway permeability in a retracted position; Figure 2 A perspective outline view of one embodiment of a medical device in its retracted position is schematically shown, the medical device engaging with fixing and locking components in the form of interdental spacers; Figure 3 A schematic outline view of one embodiment of a single medical device in its retracted position is shown. Figure 4 It schematically shows something similar to Figure 3 The view shows the medical device in the deployed position, and the sliding actuation of the control component relative to the clamping component for transmitting the direction from the retracted position to the deployed position; Figure 5 A vertical cross-sectional view schematically illustrates a specific implementation of a medical device introduced into a patient's mouth in a retracted position; Figure 6 It schematically shows something similar to Figure 5 The view shows a medical device tilted to an unfolded position, which is positioned to hold the base of the tongue. Figure 7 A schematic outline view of another embodiment of the medical device is shown, in an unfolded position and equipped with a longitudinal guide that forms a channel for inserting and withdrawing the medical device. Figure 8 A schematic perspective view of the rear of one embodiment of a longitudinal guide for a medical device is shown, the longitudinal guide having four channels of different diameters; Figure 9Two vertical cross-sectional views are schematically shown of a medical device introduced into a patient's mouth in a retracted position and an extended position, with particular emphasis on the combined movement of the rear end of the guide channel with the movement of the component; Figure 10 An exploded view of another embodiment of the system is schematically shown, particularly the inflatable interdental spacer, and on the one hand, the internal channel along the spacer for sliding insertion of a medical device is highlighted, and on the other hand, the internal channel along the guide of the medical device for sliding insertion of an instrument such as a probe or camera is highlighted. Figure 11 A schematic double view of one embodiment of the interdental spacer is shown, wherein the upper portion is in a deflated configuration on the left and an inflated configuration on the right. Figure 12 A schematic front view of one embodiment of the medical device is shown, particularly the component in the unfolded position, wherein the instrument slides along a guide in the form of a tube; Figure 13 A schematic view of one embodiment is shown, particularly the component in the deployed position and the tube passing through the guide and the component, wherein the orientation follows the component; Figure 14 A simplified view of one embodiment of a respiratory support system is schematically shown, with particular attention to the end cap for the guide channel; and Figure 15 It shows Figure 14 An enlarged view shows, in particular, the plate forming the latch and the interlocking attachment of the mask to the tooth spacer, the latch being designed to engage with a slot on the guide. Detailed Implementation

[0031] This invention relates to respiratory assistance and artificial ventilation, particularly during general anesthesia. Accordingly, this invention relates to a medical device 1 (hereinafter referred to as "device 1") for maintaining airway permeability, and a respiratory assistance system 10 (hereinafter referred to as "system 10") equipped with such device 1.

[0032] First, the device 1 is designed to circulate freely along the airway and maintain this circulation by pressing against the base or root of the tongue to push it forward (that is, toward the anatomical anterior or lateral part of the patient's skull).

[0033] Therefore, device 1 includes at least one longitudinal guide 2. According to the embodiment shown in the figure, device 1 includes two parallel extending guides 2 spaced apart from each other.

[0034] Each guide 2 can have any shape and cross-section, preferably having a flat, blade-like shape with one or more segments, thereby allowing it to be easily inserted when positioned in the oral cavity.

[0035] Furthermore, the guide 2 is long enough to allow its distal end 20 to be inserted as far as penetrating the patient's larynx, close to the root of the patient's tongue, while the proximal end 21 remains outside the mouth. Preferably, the guide 2 is longer than the length of an adult patient's oral cavity, thereby allowing it to be inserted to the root of the tongue, and also allowing the portion of the guide 2 introduced into the oral cavity to adapt to the size of the oral cavity.

[0036] In this way, guide 2 is used partly to reinforce the part to be introduced into the mouth, and partly to support other components.

[0037] Furthermore, the guide 2 extends along a curved path, meaning it has a downward bend from the proximal end 21 to the distal end 20. This bend gives the guide 2 a concave shape on its lower side, allowing it to adapt to the shape of the mouth, particularly matching the curve of the tongue. This curved path can be determined by the curved circular shape of the guide 2 or by the angle between the guide segments.

[0038] The device 1 also includes a clamping member 3 connected to the proximal end 21 of the longitudinal guide 2. This clamping member 3 can be of any shape and is adapted to allow the device 1 to be held and operated by a practicing physician.

[0039] According to one embodiment shown in the figure, the clamping member 3 includes a handle forming a hollow concave portion. This concave portion can be of any shape, preferably in the form of a semi-tube opening towards the front. The rear wall of the handle can then be positioned thereon as a physician's fingers to clamp and grip the surface of the device 1. Furthermore, when clamping the device 1, the proximal end 21 can be positioned between two fingers, thereby ensuring a secure grip.

[0040] According to the embodiment shown in the figure, the handle extends at its proximal end 21 orthogonally or substantially orthogonally to the curvature path of the guide 2. Therefore, when the guide 2 is positioned horizontally or substantially horizontally inside the oral cavity, the handle then extends vertically or substantially vertically.

[0041] According to the ability Figures 1 to 6 In the various embodiments seen, the handle extends symmetrically or substantially symmetrically on either side of the guide 2. According to another embodiment, such as... Figures 7 to 9 As shown, the handle extends below guide 2.

[0042] Furthermore, the device 1 includes at least one component 4 mounted at the distal end 20 of the longitudinal guide 2. Additionally, the component 4 includes a tongue depressor shaped to complement the anatomical structure of the tongue surface.

[0043] Specifically, the tongue depressor has a flat, rounded, and curved shape, with a recess at the bottom. Furthermore, the edges of the tongue depressor are rounded to avoid any risk of injury during insertion and withdrawal, and during use of the device 1.

[0044] Advantageously, device 1 presses forward at the base of the tongue, thereby keeping the airway open.

[0045] Therefore, the component 4 can move from the retracted position to the extended position relative to the longitudinal guide 2, and vice versa.

[0046] In the retracted position, the tongue depressor of component 4 extends along the path of the longitudinal guide 2. In other words, the tongue depressor extends as an extension of the guide 2, thereby allowing the device 1 to be inserted and withdrawn within the oral cavity until the tongue depressor reaches the base of the tongue. Figure 5 The image highlights this retracted position when device 1 is inserted into the oral cavity.

[0047] In the deployed position, the member 4 projects downward relative to the longitudinal guide 2. In other words, the member 4 forms an angle with respect to the path at its distal end 20 to press against the base of the tongue. Figure 6 The image highlights this unfolded position of component 4, which pushes the tongue back by resting it on its base.

[0048] Furthermore, the transition from one position to another and the maintenance of the unfolded position of component 4 are ensured by the clamping of the clamping component 3 by the practicing physician.

[0049] Therefore, the medical device 1 also includes a component 5 installed at the proximal end 21 for controlling the displacement of the member 4 between the retracted position and the extended position.

[0050] According to the corresponding implementation scheme, the control component 5 can take the form of a complementaryly shaped convex portion, which is designed to engage within the concave portion of the clamping component 3 in the unfolded position of the component 4. Specifically, in the case of a semi-tubular concave portion, the convex portion has a cylindrical shape, preferably a semi-cylindrical shape, with its rotating wall on the hollow side of the concave portion. The dimensions of the convex and concave portions are complementary; that is, the external dimensions of the convex portion precisely correspond to the internal dimensions of the concave portion, specifically, the diameter of the convex portion is precisely equal to the inner diameter of the concave portion. This complementary construction can be particularly effective in… Figure 3and Figure 4 I saw it in the middle.

[0051] In this way, when member 4 is actuated from the retracted position to the extended position, the convex portion of control member 5 can be inserted into the concave portion of clamping member 3, and withdrawn when actuated from the extended position to the retracted position (and vice versa). In short, by moving control member 5 toward or away from clamping member 3, member 4 can be actuated between its extended and retracted positions. Specifically, Figure 4 The movement of the control component 5 toward the clamping component 3 is shown, thereby actuating the member 4 from the retracted position to the extended position.

[0052] According to the corresponding implementation scheme, the convex portion is aligned with the concave portion and is symmetrical or substantially symmetrical with respect to the rod 50 (that is, with respect to the guide 2), or the convex portion extends below the rod 50.

[0053] According to one embodiment, one and / or the other of the convex and / or concave portions may be designed to be removable relative to the rod 50 and / or the guide 2, thereby allowing them to be removed once the device 1 is in place. This removability also makes these portions easier to clean.

[0054] According to another implementation plan, such as Figure 10 As shown, the convex and concave portions may include locking components, particularly by clamping. For this purpose, the convex portion may be fitted with a protrusion that engages by interlocking with a portion of the concave portion (preferably the lower edge of the concave portion). In this way, in the unfolded position of member 4, the convex and concave portions remain together.

[0055] Regarding the mobility of the tongue depressor, according to one embodiment, the member 4 is mounted as an extension of the distal end 20 of the longitudinal guide 2. Furthermore, the member 4 is pivotally hinged between a retracted position and an extended position. In other words, the member 4 rotates downward about the distal end 20 to reach the extended position and conversely rotates upward to return to the retracted position. For example, clockwise rotation can be used to move towards the extended position, while counterclockwise rotation can be used to return to the retracted position.

[0056] Figure 4 The clockwise rotation direction toward the unfolded position of component 4 is highlighted.

[0057] According to one embodiment, component 4 is rotatably mounted via first rings 6, which are secured to the front end of the tongue depressor at their engagement with guide 2. These first rings 6 are secured to the distal end 20 of guide 2. In particular, a pair of first rings 6 are secured to each distal end 20 of both guides 2.

[0058] Each first ring 6 can rotate freely together with the guide 2 and be attached to the component 4, and vice versa.

[0059] According to other embodiments, component 4 may be fitted with a shaft or rod rotatably mounted on the distal end 20 of guide 2.

[0060] According to another embodiment, component 4 can be mounted on the distal end 20 by means of a resilient joint, which is made of a material (such as natural or synthetic rubber) that allows it to bend or fold relative to guide 2.

[0061] According to the preferred embodiment, component 4 is actuated by means of a cam-shaped mechanical linkage device, that is, translation causes component 4 to rotate.

[0062] Therefore, according to one embodiment, as shown in the figure, the control component 5 includes at least one lever 50, which is rotatably connected to the member 4 at one end.

[0063] According to another equivalent embodiment, the at least one rod 50 may be in the form of a rigid, semi-rigid, or even flexible connector (such as a cable). In this case, the control component 5 may operate independently or in combination with the clamping component 3, like a bicycle brake lever.

[0064] According to one embodiment, component 4 is rotatably mounted via second rings 7, which are fixed to the front end of the depressor plate at their engagement with rod 50. These second rings 7 (especially in pairs) are fixed to the rear end of rod 50.

[0065] Each second ring 7 can rotate freely together with the rod 50 and be attached to the component 4, and vice versa.

[0066] According to other embodiments, component 4 may be fitted with a shaft or axle rotatably mounted on the rear end of rod 50.

[0067] Furthermore, the rod 50 is slidably mounted relative to the longitudinal guide 2. According to a corresponding embodiment, the rod 50 is slidably mounted within the gap between the two guides 2. In other words, the rod 50 moves in a translational manner relative to the guides 2, particularly relative to the two guides 2 that frame the rod, thereby serving as a longitudinal guide.

[0068] Preferably, the rod 50 slides along the guide 2 via a sliding connection.

[0069] According to one embodiment, similar to guide 2, rod 50 may have a flat shape having one or more segments, and a curvature or bend parallel to or along the path.

[0070] According to another embodiment, the rod 50 forms part of the guide 2 in a telescopic manner, thereby allowing it to extend to activate the member 4 toward the deployed position (or toward the retracted position), or conversely, to activate the member when it retracts (or conversely, toward the deployed position).

[0071] Furthermore, the sliding of the rod 50 relative to the longitudinal guide 2 ensures that the member 4 switches from the retracted position to the deployed position in one direction. In particular, the translational movement of the device 1 from front to back (that is, from the anterior or anterolateral anatomical portion of the skull to the posterior portion) activates the rotation of the member 4 toward the deployed position, i.e., when the control member 5 is pushed.

[0072] In the opposite direction, sliding of rod 50 ensures that component 4 returns from the deployed position to the retracted position. Specifically, a backward-forward translational movement actuates the rotation of component 4 toward the retracted position, i.e., by pulling control component 5.

[0073] In short, preferably, the switching of the member 4 is controlled in a translational direction extending from the proximal end 21 toward the distal end 20 by bringing the control member 5 closer to the clamping member 3. This displacement is achieved by... Figure 4 and Figure 5 The location shown in the image is displayed.

[0074] According to the corresponding implementation, the clamping member 3 includes a handle forming a hollow concave portion. Furthermore, the rod 50 passes through the handle, specifically through an opening arranged to pass through the wall of the handle.

[0075] The control component 5 includes a convex portion mounted at the opposite ends of the rod 50.

[0076] Furthermore, as previously mentioned, the convex portions are complementaryly shaped and are designed to engage within the concave portions in the unfolded position of the member 4.

[0077] In this way, as the control component 5 moves toward and away from the clamping component 3, the rod 50 fixed to the convex portion slides freely within the opening of the concave portion.

[0078] According to an alternative embodiment, the control unit 5 may include a manual actuator in the form of a trigger or the like, which controls the transition from the retracted position to the extended position.

[0079] It should be noted that by means of the elastic reset component, the component 4 can be rotated around its rotation axis, or the control component 5 can be pushed back or pushed toward the clamping component 3, so that it can automatically return to the retracted position.

[0080] Furthermore, the retention in the unfolded position can be locked by any type of component, particularly by latching the control component 5 to the clamping component 3, by clamping, by means of a one-way interlocking element (e.g., using teeth and protrusions), or in the form of a latch, or by means of an adhesive that connects the components 3 and 5 together. Unlocking can be performed by any corresponding component (particularly by means of a button) that unlocks the latch or clamping of the devices 3 and 5.

[0081] Specifically, in the corresponding implementation, locking and unlocking occur between the convex and concave portions.

[0082] In addition, locking and unlocking are performed on the external part of device 1, thereby allowing the practicing physician to easily access it.

[0083] In this way, the clamping member 3 performs the function of moving the member 4, either alone or in conjunction with the control member 5. In particular, the handle of the clamping member 3 can be connected to the proximal end 21 to control the positional changes of the member 4 located at the distal end 20.

[0084] Accordingly, the device 1 and its components can be made of any type of material preferably compatible with medical applications, such as surgical steel, composite materials, and / or plastic-based materials. In particular, the guide 2 and rod 50, as well as the clamping member 3 and control member 5, can be made of plastic, especially by molding.

[0085] According to one implementation, device 1 is designed to facilitate the insertion and removal of medical device 8.

[0086] Such medical devices 8 may include, but are not limited to, endotracheal probes, endoscopic camera systems, one or more sensors for measuring (especially temperature), or sampling systems (especially sampling systems for biopsies).

[0087] For this purpose, the guide 2 may include at least one channel 22 that extends upward and is used to guide the device 8 longitudinally along the guide 2.

[0088] According to the preferred implementation scheme, such as Figure 7 and Figure 8 As shown, the at least one longitudinal guide 2 includes at least one channel 22 for inserting and withdrawing the medical device 8. This channel 22 then imparts the longitudinal shape of the hollow beam to the guide 2, thereby acting as a conductor and allowing the medical device 8 to slide along the beam without the risk of contact with the walls of the patient's mouth.

[0089] For example, Figure 13An instrument 8 of the probe tube type is shown inserted along a channel 22 within a longitudinal guide 2. The probe tube is oriented downward as it passes through a member 4 in the unfolded position, particularly through a circular tubular portion on one side of the guide 2 where the member 4 is located.

[0090] According to the corresponding implementation scheme, at least one of the medical devices in the medical device 8 has a guide channel passing through the component 4, and the entrance of the guide channel is aligned with the exit of the at least one channel 22.

[0091] Specifically, a single guide channel aligned at the outlet of the intermediate channel 22 of the guide 2 passes through the member 4, such that in the unfolded position of the member 4, the guide channel forms a rounded corner, thereby ensuring that the distal end of the device 8 and the member 4 penetrate downward during the insertion and sliding of the device 8 along the channel 22 of the guide 2.

[0092] Specifically, the guide 2 includes a plurality of collinear channels 22 (particularly at least three or four channels 22) having the same or different inner diameters, thereby allowing the passage of medical instruments 8 with corresponding circumferences. Specifically, the larger, preferably central, channel 22 allows the passage of an endotracheal tube or a cannula preferably used for inserting such an endotracheal tube, while the smaller diameter channel allows the passage of instruments 8 (such as probes or endoscopes). In this way, once the device 1 has been installed, the endotracheal tube can be easily and reliably inserted into the trachea through its correctly positioned cannula.

[0093] Open at the front, each channel 22 allows a physician to easily and quickly insert and withdraw medical devices 8 by being guided along each of the channels 22 of the guide 2, without having to worry about managing their paths.

[0094] At least one channel 22 can be sealed at its outer end. For this purpose, the device 1 includes closure members 220, the dimensions of which are complementary to the dimensions of the corresponding channel 22. These closure members 220 are intended to be removable so as to close each channel 22 not used for insertion or withdrawal of the medical device 8. In the sealed position, these closure members 220 seal or hermetically seal the corresponding channel 22, particularly by means of the material they are made of (such as elastic materials, composite materials, or synthetic rubber).

[0095] Furthermore, the at least one insertion and withdrawal channel 22 extends to a rear end 23, which is fixed to the member 4.

[0096] According to one embodiment, the insertion and withdrawal channel 22 includes a flexible rear end portion 23.

[0097] According to another embodiment, the rear end 23 of the insertion and withdrawal channel 22 is hinged.

[0098] In this way, the rear end 23 of the channel 22 can follow the movement of the component 4, such as... Figure 9 As can be seen in the view shown.

[0099] In another embodiment, the rear end 23 has an angled or inclined outlet opening 24 that slopes upward and forward from the member 4. The outlet opening 24 may optionally be slightly open. This particular shape facilitates the guidance of the medical device 8 out of the body, especially during its withdrawal.

[0100] Therefore, the possibility of inserting an endoscope camera system that is properly and securely installed, separate from other medical devices, offers the advantage of monitoring the presence of unwanted contents in the oropharyngeal cavity, or even envisions the passage of a probe with a suction device to remove unwanted contents.

[0101] This monitoring allows for checking the insertion of the endotracheal tube, thus ensuring perfect insertion at any time during the procedure.

[0102] Furthermore, the use of device 1 solves the problems associated with difficult and complex intubation, such as in cases of complex airway anatomy. The use of device 1 ensures accurate insertion of the endotracheal tube into the larynx while maintaining ventilation via mask 11, and thus ensures immediate oxygenation after device 1 has been installed, even before any endotracheal intubation. There is then no time limit for inserting the endotracheal tube into the trachea, making it easier and less stressful for physicians.

[0103] According to the corresponding implementation, the clamping component 3 can be attached to one of the medical devices 8 to be introduced into the at least one channel 22, preferably at the distal end of an endoscopic probe or endoscope. Therefore, when the device 8 is inserted, its inward sliding along the at least one channel 22 causes the component 4 to switch to the deployed position. Conversely, by retracting the device 8, the component 4 returns to the retracted position.

[0104] By inserting an instrument 8 (such as an endoscope camera), the correct positioning of the device 1 (especially the switching of the orientation of the component 4 towards the unfolded position) can be directly visualized, allowing the device to rest against the base or root of the tongue so that the device can be pressed forward.

[0105] Therefore, the device 1, with its slender, flat shape, can be easily inserted into the patient's mouth. The physician securely clamps the device from outside the mouth with good clamping force, thereby allowing only the component 4 to unfold to push the tongue back at the base of the tongue and ensure that the airway remains passable.

[0106] Furthermore, once in place and deployed, device 1 allows the physician to implant the relevant medical devices 8 (including cannulas, if needed) and to pass tubes, catheters, or probes. Device 1 can then be used to guide the introduction of these devices 8, particularly along the guide 2 and rod 50.

[0107] The present invention also relates to a respiratory support system 10.

[0108] This system 10 is designed to be non-invasive, that is, to provide artificial ventilation without intubation or medical devices 8 penetrating the mouth, relying solely on the naturally occurring circulation from the lungs through the mouth and nose.

[0109] For this purpose, system 10 is of the type of breathing mask, and therefore includes a breathing mask 11 at the top. This mask 11 is anatomically shaped to at least cover the nose of the patient's face.

[0110] In particular, the mask 11 has an overall shell shape. This shell can be made of any material suitable for the medical field, such as plastic or composite materials.

[0111] The shape of the mask 11 allows its periphery to rest above the upper lips and bridge of the nose, as well as on the cheeks, thereby enveloping that portion of the patient's face. Depending on its construction, the mask 11 can be designed to cover one side of the cheekbone and jaw area, or only the nose area.

[0112] In addition, the mask can be held in place on the patient’s head by special components (such as adjustable straps or at least one elastic band) around the skull or behind the ears, thereby providing sufficient tension to press the mask 11 airtight against the patient’s skin.

[0113] According to one embodiment, the circumference of the face mask 11 may include a peripheral seal 12 made of a flexible and / or elastic material to ensure close contact with the skin of the face when the face mask 11 is pressed against it. In particular, such a seal 12 may be made of a composite material (especially silicone) to ensure adhesive or sticky contact with the skin.

[0114] According to one embodiment, the circumference of the mask 11 can be secured and held in place on the patient's face by means of an adhesive that laterally protrudes from a peripheral seal 12 surrounding the circumference of the mask 11.

[0115] Alternatively or additionally, other fastening components may be envisioned to ensure that the mask 11 is positioned and held on the patient's face in an airtight manner.

[0116] Moving further forward, the mask 11 includes a front face 13 and a through channel 14 designed for airtight connection to an artificial ventilation device.

[0117] It should be noted that such an artificial ventilation device can be included in system 10. This device can be any type, particularly a specialized electrical device, such as a mechanical or auxiliary ventilation device, or a manually operated balloon. The artificial ventilation device is connected to the mask 11 via a grooved tube or manifold provided for this purpose, which is installed with the channel 14 in a sealed, interlocking manner.

[0118] In addition, the mask 11 also includes a back side 130 positioned opposite the front side 13. Therefore, the back side 130 is located on one side of the patient's face.

[0119] According to one embodiment, the system provides that the breathing mask 11 includes a removable section 111 that is fitted in front of the mask 11 to cover the nose of the patient's face. Therefore, this removable section 111 can be positioned and removed from the mask 11, making it easier to place the mask 11 on the patient's face.

[0120] In addition, section 111 is designed to be airtightly assembled by interlocking with the mask 11.

[0121] In this way, the mask 11 can be positioned and adjusted on the patient's face before anesthesia is initiated, without hasty manipulation. The removable segment 111 can then be positioned as a closed mask 11, particularly after the patient has begun anesthesia, that is, only when mechanical ventilation replaces spontaneous ventilation. This configuration of the mask 11 produces a high concentration of oxygen inhaled by the patient.

[0122] According to one embodiment, the removable section 111 includes the through passage 14.

[0123] According to one implementation, particularly when the through passage 14 leads to a removable section 111, the removable section includes an air filter, thereby allowing the elimination of pathogens and bacteria, and thus reducing the need for intervention with the filters of the artificial ventilation equipment.

[0124] Advantageously, system 10 includes a medical device 1 for maintaining airway permeability according to one and / or another embodiment of the previously described embodiments.

[0125] In addition, system 10 includes components for securing and locking the device 1 inserted into the patient's mouth.

[0126] Furthermore, to allow easy operation of the device 1 and the actuating member 4 between the retracted and extended positions, the device 1 is continuously mounted between the face mask 11 and the fixing and locking member. Additionally, the clamping member 3 and the control member 5 are located on one side of the front face 13 of the face mask 11.

[0127] According to one embodiment, the mask 11 may include an opening through its lower wall and toward a rear opening of the outer shell. Specifically, two openings may be present opposite the nose opening. These openings allow communication between the mouth and nose, such as a suture.

[0128] According to one embodiment, these openings can lead to the front 13 of the mask 11 and can be connected to a gas supply source, particularly an oxygen (O2) supply source. Such a supply source may include a nozzle or conduit fixed to the front 13 of the mask 11. In this way, the nozzle or conduit of the supply source can be connected (particularly via a conduit) to an oxygen supply network.

[0129] According to the corresponding implementation plan, when the mask 11 is closed, the interlocking closure (especially the tight closure) opening of section 111 can be removed, thereby shutting off the oxygen supply.

[0130] According to one embodiment, the locking and securing component includes an interdental spacer 17. This interdental spacer 17 is anatomically shaped to rest against the patient's dentition below and / or above.

[0131] According to an implementation plan, such as Figure 10 As shown, the interdental spacer 17 can be connected to the mask 11 from below at its outer portion. This connection can be hinged and removable, particularly by clamping a pin in a complementary gripper protruding from the lower portion of the mask 11.

[0132] According to another embodiment, the mask 11 can be clamped to the interdental spacer 17 via complementary interlocking lugs and cavities (particularly through plastic and elastic deformation of the material).

[0133] In particular, this structure is capable of Figure 14 and Figure 15 I saw it in the middle.

[0134] According to one embodiment, the interdental spacer 17 includes an inflatable internal portion 173, which is designed to hold the medical device 1 in the patient's mouth.

[0135] It should be noted that the inflation and deflation of the internal portion 173 is performed by a suitable component (e.g., using a manually operated pump) connected via the mask 11 (particularly via a channel or pipe connected to the internal portion).

[0136] Therefore, once the mask 11 is in place, before or after the medical device 1 is introduced into the patient's mouth, the inflation of the inner portion 173 of the interdental spacer 17 locks the system 10 in place and holds it in the patient's oral cavity, while adapting to the patient's shape. Furthermore, inflating the inner portion 173 improves the seal provided by the system 10 in the oral cavity.

[0137] According to one embodiment, the interdental spacer 17 includes a tube 177 for circulating gas (such as oxygen) connected to each end, that is, passing through the interdental spacer 17 to an outlet end 178 inside the interdental spacer 17.

[0138] According to one embodiment, the interdental spacer 17 includes an upper portion 170 and a lower portion 171 connected to each other. By slightly opening portions 170 and 171, the interdental spacer 17 can then be moved along the device 1 to adapt to the individual morphological characteristics and anatomy of each patient.

[0139] According to one embodiment, the upper portion 170 of the interdental spacer 17 is mounted to integrally protrude from the back surface 130 of the mask 11. This upper portion 170 is fixed and stationary relative to the mask 11, thereby allowing it to be easily positioned in the patient's mouth.

[0140] According to the corresponding implementation, the upper portion 170 or the lower portion 171 of the interdental spacer 17 is designed to be inflatable, or both are designed to be inflatable. Preferably, only the lower portion 171 is designed to be inflatable.

[0141] Figure 11 An example embodiment of such an interdental spacer 17 with an inflatable internal portion 173 is shown, illustrating the internal portion 173 being deflated on the left and inflated on the right.

[0142] In this way, the mask 11 is positioned with the upper portion 170 against the patient's upper jaw, and the patient only needs to close their mouth to bring portions 170, 171 closer to the interdental spacer 17, thereby ensuring sufficient clamping force to hold the mask 11 while allowing the device 1 to pass between portions 170, 171.

[0143] Furthermore, according to one embodiment, the portions 170, 171 include at least one bevel 172 for receiving the patient's dentition. Specifically, as... Figure 2 As can be seen, each channel 172 has a hollow, arched shape, and its dimensions are complementaryly designed to accommodate the patient's teeth internally.

[0144] According to a preferred embodiment, each groove 172 comprises a material with elastic properties (particularly flexible, or even shape memory, preferably temporary). Specifically, the bottom of one and / or the other groove 172 of one of portions 171, 172 and / or the other is covered with the elastic material. This material can be used to press against the teeth and secure the interdental spacer 17.

[0145] Alternatively, the entire interdental spacer 17 may be made of a flexible and / or elastic material (preferably having shape memory, such as a plastic gel or composite material).

[0146] Furthermore, this interdental spacer 17 can be made of any type of material suitable for medical and dental applications (preferably composite materials or plastic-based materials, or even natural or synthetic rubber). In particular, the interdental spacer 17 can be manufactured by molding the patient's dentition or by taking a dental impression, thereby ensuring its proper implantation and retention in the mouth.

[0147] Furthermore, the medical device 1 passes through the interdental spacer 17 between the component 4 and the clamping member 3.

[0148] According to the corresponding implementation scheme, the guide 2 and the rod 50 pass through the inter-tooth spacer 17.

[0149] Furthermore, the interdental spacer 17 can be slidably mounted along the guide 2 and the rod 50, thereby allowing adjustment of the insertion length of the device 1 within the patient's mouth.

[0150] Therefore, when the patient's mouth is closed, the interdental spacer 17 clamps the device 1 (in particular the rod 50), thereby preventing the device from being in the unfolded position of the member 4.

[0151] It should be noted that the mouth can be locked in a closed position by any means, including chin straps or ties, or even adhesives.

[0152] In this way, the device 1 is locked and held by the interdental spacer 17 simply by closing the patient's mouth, causing the patient's teeth to bite into the interdental spacer 17, thereby clamping the device 1 in place. This configuration is more suitable for treating patients with mouth shapes adapted to insertion of the interdental spacer 17, and is particularly suitable for adults.

[0153] According to one embodiment, the fixing and locking component includes at least one plate 18 that is translatably mounted along the longitudinal guide 2. Furthermore, the guide 2 is provided with notches 19 that provide indexing positions for fixing the plate 18. In other words, the notches 19 are positioned and spaced along the guide 2, thereby allowing the plate 18 to be placed closer or further away, thus adapting to the length of the portion of the device 1 entering the mouth, so that the member 4 is positioned as optimally as possible against the tongue, as close as possible to the base of the tongue.

[0154] According to a preferred embodiment, the notch 19 is in the form of a rod and is positioned to protrude from or recess into the top surface of the guide 2, in particular connecting the two guides 2 to each other.

[0155] According to another embodiment, the notch 19 is formed as a slot on the surface of the guide 2 (preferably on its top surface). These slot-shaped notches 19 are designed to mate with a plate 18, which forms a latch that is mounted to be vertically movable relative to the guide 2, and thus from an elevated position to a lowered position relative to the notch 19. In the elevated position of the latch, the guide 2 slides freely, while in the lowered position, the lower edge of the latch engages in the corresponding slot, thereby preventing translation of the guide 2.

[0156] exist Figure 12 This notch 19, which is in the form of a slot, can be seen engaging with the latch.

[0157] According to one embodiment, the latch forming plate 18 is interlocked in place by lugs protruding within corresponding recesses. Specifically, the lugs protrude from the wall of the plate 18, and the recesses are recessed into an insertion slot of the plate 18, the slot extending through the thickness of the interdental spacer 17 until it opens inward, particularly within the sleeve 174.

[0158] In particular, this structure is capable of Figure 15 I saw it in the middle.

[0159] According to a preferred embodiment, the fixing and locking component further includes a lip support 190, which is freely and translationally mounted between the plate 18 and the member 4 along the longitudinal guide 2.

[0160] According to another implementation plan, such as Figure 11 As shown, the support 190 can be fixedly mounted to the interdental spacer 17 on the side opposite to the internal portion 173, especially if the interdental spacer is designed to be inflatable.

[0161] The inner portion 173 is then connected to the support 190 via a sleeve 174, the sleeve being complementary in size to allow insertion and sliding of the guide 2. In short, the guide 2 can slide freely from an inlet opening 175 arranged along the sleeve 174 through the support 190 to open at the inner portion 173 via an outlet opening 176.

[0162] Furthermore, when manipulating all or part of the medical device 1 and / or the instrument 8 inserted therein, the support 190 can then be used as a stop for the clamping member 3.

[0163] In the corresponding implementation, the latch can be mounted to be vertically movable relative to the support 190, that is, the latch slides vertically within its thickness, such as... Figure 14 As you can see.

[0164] This lip support 190 can be of any shape, including round or oval.

[0165] The lip support 190 can be made of any type of material (preferably flexible and / or elastic, such as composite or plastic-based materials, or natural or synthetic rubber). This elastic feature allows the lip support 190 to slide along the guide 2 and rest against the lip. Furthermore, the elastic material can lock relative to the guide 2 lever 50.

[0166] Furthermore, during adjustment according to one of the graduated positions, the plate 18 presses against the outside of the lip support 190. In other words, when the device 1 is placed, it is inserted into the patient's mouth and the actuating member 4 changes from a retracted position to an extended position. Then, after the mouth is closed, the lip support 190 is moved such that its inner surface presses against the patient's lips. The plate 18 is then positioned against the outside of the lip support 190 in a position graduated by a corresponding notch 19. The notch 19 then locks the plate 18 against the lip support 190, which is hermetically adhered to the patient's lips, particularly through localized deformation due to its elastic material.

[0167] Therefore, between the plate 18 and the member 4 in the unfolded position, the device 1 is engaged in the patient's mouth by fastening it with the base of the lips and tongue, thereby ensuring its retention.

[0168] According to the corresponding implementation, when the at least one longitudinal guide 2 of the medical device 1 includes at least one (preferably multiple) channels 22 for inserting and withdrawing the medical device 8, a through opening is provided for each of the at least one insertion and withdrawal channels 22, facing the plate 18 and optionally the lip support 190. In other words, once the plate 18 is in place to hold the device 1 in its unfolded position from the member 4, the medical device 8 can be introduced and withdrawn via the opening aligned with the channel 22.

[0169] This implementation may be combined with any one or two of the implementations that include the interdental spacer 17, or may not be combined with it.

[0170] It should be noted that once system 10 is in place, the mouth can be sealed by means of adhesive application while keeping the lips clamped together, or by means of medical tape.

[0171] As an example of using the respiratory support system 10, in the context of general anesthesia, pre-oxygenation is performed for one to three minutes once the mask 11 is positioned on the patient's face and connected to the mechanical ventilation device via the channel 14. The mask 1 can then be secured in place by means of elastic bands or adhesives.

[0172] The patient is then placed under anesthesia. Because the installation of device 1 is a painless procedure that moderately stimulates the reflex area, anesthesia can be limited to a superficial level, and no narcotic analgesics are used at this stage, which in most cases allows for natural breathing and significantly reduces the risk of hypoxia or hypercapnia.

[0173] After achieving an anesthetic level that suppresses consciousness, gag reflex, and swallowing reflex, thereby ensuring full relaxation of the oropharyngeal muscles, the patient's mouth is opened to insert device 1, with component 4 in the retracted position. A tongue depressor is placed behind the tongue, similar to the introduction of an anesthetic laryngoscope.

[0174] Once in place, the control component 5 is actuated to bring the clamping component 3 closer together, thereby causing the component 4 to switch and press against the base of the tongue and the epiglottis, thus opening the airway.

[0175] Then, according to the components corresponding to the above-described embodiment, device 1 is locked and secured. If necessary, the nozzle is airtightly sealed.

[0176] Then provide full respiratory support, and may deepen anesthesia, use inhaled anesthetics, and administer muscle relaxants.

[0177] In a supplemental manner, an oxygen supply can be provided (particularly at an appropriate respiratory concentration) once the mask 11 is in place, prior to placing the patient under anesthesia. The oxygen supplied from the source exits through openings, particularly in the form of a curtain when the openings are arranged in a row. As previously mentioned, this supply is then closed through the sealing openings when the removable section 111 is positioned.

[0178] In the hands of an experienced operator, this procedure for implanting device 1 and system 10 takes only a few seconds, which, combined with the possible preservation of spontaneous breathing, significantly reduces the risk of hypoxia and hypercapnia.

[0179] In this way, the respiratory support system 10, combined with the fixation and locking of the device 1 for maintaining airway permeability, ensures implantation without the risk of damage to the mucosa or lining, and without trauma. Once in place, the device 1 is locked in place, eliminating the risk of accidental movement, especially if the patient needs to be moved or transported. The system 10 and its device 1 can be used for emergency interventions and for medical procedures requiring anesthesia. Finally, the system 10 uses the airway to provide natural ventilation without the need for intubation. Furthermore, the advantage of the system 10 and device 1 is that once anesthesia ends, the patient adapts and recovers to fully independent breathing more quickly.

[0180] Furthermore, whether or not connected to system 10, device 1 enables modification of current anesthesia techniques, particularly those requiring endotracheal intubation, such as in cases of large-scale surgery (especially large abdominal surgery, including esophageal and gastric surgery, particularly for the treatment of obesity).

[0181] Specifically, intubation can be performed and maintained during anesthesia and part of the surgical procedure via the mask 11 of the ventilator-assisted ventilation system 10, followed by extubation immediately after the main phase of the surgery, and then respiratory assistance is applied almost simultaneously thereafter. This procedure reduces the time required for endotracheal intubation and makes it easier for the patient to resume spontaneous breathing.

Claims

1. A non-invasive respiratory support system (10) of the type of breathing mask, the system comprising: -A breathing mask (11) at the top, which is anatomically shaped to at least cover the nose of the patient's face. The mask (11) includes a front (13) and a through channel (14) designed to be airtightly connected to an artificial ventilation device; - A medical device (1), said medical device for maintaining airway permeability and comprising: - At least one longitudinal guide (2), the at least one longitudinal guide extending along a curved path; - Clamping component (3), the clamping component is connected to the proximal end (21) of the longitudinal guide (2); - At least one component (4), said at least one component being mounted at the distal end (20) of the longitudinal guide (2), The component (4) includes a tongue depressor that is complementary to the anatomical structure of the tongue surface. The component (4) is capable of shifting relative to the longitudinal guide (2) from the retracted position to the deployed position and vice versa. i) In the retracted position, the tongue depressor of the member (4) extends along the path of the longitudinal guide (2); ii) In the deployed position, the member (4) protrudes downward relative to the longitudinal guide (2); The medical device (1) also includes a component (5) installed at the proximal end for controlling the displacement of the member (4) between the retracted position and the deployed position. The system (10) is characterized in that it comprises: - Components for securing and locking the device (1) inserted into the patient's mouth; - The device (1) is installed to pass between the mask (11) and the fixing and locking components, with the clamping component (3) and the control component (5) positioned toward the front (13) of the mask (11).

2. The system (10) according to the preceding claim, characterized in that... - The fixing and locking components include an interdental spacer (17) anatomically shaped to abut against the patient's dentition below and / or above, the interdental spacer having an upper portion (170) and a lower portion (171). The medical device (1) passes through the interdental spacer (17) between the component (4) and the clamping member (3).

3. The system (10) according to the preceding claim, characterized in that... - The interdental spacer (17) includes an inflatable internal portion designed to hold the medical device (1) in the patient's mouth.

4. The system (10) according to any one of claims 2 or 3, characterized in that - The interdental spacer (17) includes a latch that is vertically movable on a support (190) connected to the spacer (17) via a sleeve (174), the latch engaging with a notch (19) provided in the at least one guide (2).

5. The system (10) according to any one of the preceding claims, characterized in that... - The breathing mask (11) includes a removable section (111) which is fitted in front of the mask (11) to cover the nose of the patient's face.

6. The system (10) according to the preceding claim, characterized in that... - The removable section (111) includes the through passage (14).

7. The system (10) according to any one of the preceding claims, characterized in that... - The at least one longitudinal guide (2) of the medical device (1) includes at least one insertion and extraction channel (22) for the medical device (8).

8. The system (10) according to the preceding claim, characterized in that... - One of the medical devices (8) includes the clamping member (3) and extends longitudinally within the at least one channel (22) to allow the member (4) to move between the retracted position and the deployed position.

9. The system (10) according to any one of claims 7 or 8, characterized in that... - A guide channel for at least one of the medical devices (8) passes through the member (4), the entrance of the guide channel being aligned with the exit of the at least one channel (22).

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