Ventilation assistance device

Abstract

A ventilation assembly (37) for use in ventilating a subject using a laryngeal mask (5) includes a head-worn strap (39) and a pusher (41). The strap may be disposed on a head (H) of the subject to support the pusher to press a floor of mouth (15) of the subject (P). The pusher comprises laterally opposed protrusions so as, in use and with the strap operably supported on the subject (P), to displace soft tissue of the subject at a left and right submaxillary triangle in the skull direction with respect to a mandible (29) of the subject and surrounding tissue of the subject, such as subchin triangle, such as subchin triangle, and to displace the soft tissue of the subject at the left and right submaxillary triangle in the skull direction with respect to the mandible (29) of the subject and the surrounding tissue of the subject, such as subchin triangle, in use and with the strap operably supported on the subject (P), and to displace the soft tissue of the subject at the left and right submaxillary triangle in the skull direction. The laryngeal mask is used for pushing internal soft tissue of the subject towards the laryngeal mask in the airway of the subject when the laryngeal mask is installed in the airway of the subject. Each projection or the entire pusher is hollow, providing a recess for receiving an operator's finger.

Description

Technical Field

[0001] The present disclosure relates to a headband, and more particularly to a headband for use in a medical procedure when a laryngeal mask is used to ventilate a subject. Background Art

[0002] Subjects who are unable to breathe normally, for example when injured and / or sedated, may receive mechanical ventilation. Intubation is a well-known forced ventilation technique. Forced ventilation using a laryngeal mask airway is also well established and is generally preferred to intubation due to its less invasive nature. For example, various aspects of laryngeal masks are disclosed in WO 2012 / 024728. Although laryngeal masks are developed to effectively seal against the throat, this seal may not be perfect and air leaks may persist, for example due to differences in the patient's anatomy relative to the available mask shapes and sizes. Sedation and muscle relaxation may cause or exacerbate such leaks. Such leaks may affect the control of ventilation volume and / or the control of the composition of the ventilation mixture, which may, for example, contain one or more moisture, sedatives, diagnostic substances and / or drugs relative to the ambient air. Therefore, such leaks should be prevented.

[0003] In practice, if a laryngeal mask is found to have a persistent leak, possibly after repeated reapplications, practitioners tend to use a larger mask size, i.e., upsizing. However, if the leak persists despite this and / or if this larger mask does not fit, intubation is ultimately performed.

[0004] It would therefore be desirable to prevent such leakage and / or increase the likelihood of effective use of the laryngeal mask.

[0005] GB 2 267 034 discloses a laryngeal mask airway clamp in which a laryngeal mask airway device is clamped in place by a clamping member that engages the patient's neck opposite the laryngeal mask of the device. The clamp engaging the neck presses against the airway, and a portion of the clamp extends into the patient's mouth and throat, which may interfere with access to the airway and / or treatment of the patient.

[0006] It should also be noted that several devices are known for establishing and maintaining a subject's mandible or lower jaw in a desired position relative to the upper jaw, but these devices are unrelated to and / or incompatible with laryngeal masks (see also below). For example, US2018 / 0008452 relates to a device for forcing the mouth closed during sleep to reduce snoring and / or treat sleep disorders such as sleep apnea. In one aspect, the device comprises a jaw block that is secured under the user's chin and also contacts the clavicle area of the upper chest. In another aspect, a device of the present invention comprises a jaw block in combination with a continuous positive airway pressure (CPAP) mask and headgear for use in a CPAP system. A CPAP mask is worn on the user's face, in contrast to a laryngeal mask that is inserted into the user's throat.

[0007] It is important to note that several devices are known for establishing and maintaining a subject's mandible or mandible in a desired position relative to the maxilla, and these devices are configured and intended to overcome airway obstruction, rather than compressing the airway to achieve a tight seal against a laryngeal mask, as described above. Therefore, these devices are not relevant to the use of forced ventilation.

[0008] For example, US2005 / 0247309 and US2009 / 0095309 disclose rigid support devices for pushing a patient's lower jaw forward from the patient's chest to enable the patient to breathe freely during sedation or sleep. Their operation depends on the patient's posture and (im)mobility.

[0009] US2010 / 0294284 discloses a device, system and method for constraining and / or supporting tissue structures along the airway by wearing a support collar. The collar may prevent access to the throat and / or limit the wearer's mobility.

[0010] US2007 / 0079832 and US2015 / 0164726 are frames mounted near a patient's head for assisting the patient's breathing. These devices are configured to push the patient's lower jaw forward to enable the patient to breathe freely during sedation or sleep.

[0011] US Pat. No. 7,124,758 discloses a device for treating snoring and obstructive sleep apnea. The device in US Pat. No. 7,124,758 comprises a headband and two straps. The headband is worn on the user's head, with the straps connected to the front of the headband. The straps cross over the top of the user's head, then pass behind the user's neck, cross under the chin, and reconnect to the front of the headband. When in use, the device maintains sufficient tension to keep the user's lower jaw locked together and the mandibular front teeth in contact with the maxillary front teeth, thereby overcoming airway obstruction, alleviating obstructive sleep apnea, and reducing the associated morbidity.

[0012] US 7,047,977 teaches a medical device for overcoming airway obstruction caused by the tongue of a sedated or unconscious patient in the supine position.

[0013] WO 2021 / 049941 discloses a ventilation assembly (37) for use in ventilating a subject using a laryngeal mask (5), comprising a headband (39) and a pusher (41). The band can be arranged on the subject's head (H) to support the pusher to press the floor of the subject's (P) mouth (15). The pusher is arranged to displace the soft tissue of the floor of the mouth toward the skull relative to the subject's mandible (29) so as to push the subject's internal soft tissue toward the laryngeal mask in the subject's airway when the laryngeal mask is installed in the subject's airway.

[0014] Although this works very well, further improvements to this type of component are still desired. Summary of the Invention

[0015] In view of the above, a ventilation assembly and a head-mounted harness are provided herein.

[0016] Specifically, a ventilation assembly for use in ventilating a subject using a laryngeal mask is provided, comprising a head-mounted strap and a push piece. The strap can be arranged on the subject's head to support the push piece to press the floor of the subject's mouth. The push piece includes laterally opposed protrusions so that when in use and when the strap is operably supported on the subject, the soft tissue of the subject at the left and right submandibular triangles (trigonum submandibulare) is displaced toward the skull relative to the subject's mandible and the subject's surrounding tissue (e.g., submandibular triangle (trigonum submentale)), so as to push the subject's internal soft tissue toward the laryngeal mask in the subject's airway when the laryngeal mask is installed in the subject's airway. Each protrusion is hollow, providing a recess for accommodating the operator's fingers.

[0017] This facilitates manipulation and placement of the pusher. Caregivers such as doctors and nurses are trained to provide care to patients based on touch and biofeedback. By placing one or more fingers into the protrusions, they can position the pusher at the appropriate location on the patient's mouth floor and adjust the pressure to displace the internal soft tissue of the patient's mouth floor. This is particularly facilitated by providing a recessed portion on the bottom (caudal side, when in use) side of the pusher.

[0018] The push piece can be roughly U-shaped in the transverse direction, including a bridge portion located in the front (when in use: ventral) part, which is used to accommodate tissue of the subject in the submental triangle when in use and when the strap is operably supported on the subject, and laterally opposite legs (41L) extending backward (when in use: dorsal) from the bridge portion, which legs are located in the rear (when in use: dorsal) part and include laterally opposite protrusions.

[0019] This may aid in positioning and / or orienting the pusher and projection relative to the mandible.

[0020] The pusher can be formed as a continuous hollow body, such as a shell and / or a monocoque structure. This can provide a strong pusher that can resist deformation and / or can facilitate the manufacture of the pusher, such as by molding techniques and / or sheet metal forming techniques.

[0021] The pusher can have a substantially constant thickness in a direction perpendicular to the outer surface of the pusher. This can facilitate positioning of the pusher; and / or improve biofeedback to the caregiver by enabling the caregiver to "feel through" the pusher to the subject; and / or by providing a constant distance between the caregiver's finger on one side of the pusher and the subject and its anatomical structures on the other side of the pusher thickness, without changing the spacing between the caregiver's finger and the subject / subject's features due to variations in the thickness of the pusher.

[0022] The bridge and protrusions can provide a substantially continuous, smooth outer (subject-facing / subject-contacting, when in use) surface, with the bridge having a saddle shape that helps prevent localized pressure variations, particularly excessive pressure that could damage the subject's skin and / or underlying tissue (e.g., providing excessive localized pressure that could reduce or block blood flow). The surface can be closed or can at least partially include openings that can help oxygenate the subject's skin and / or reduce moisture accumulation.

[0023] The protrusion may have an apex which, when in use, is located in a position range between about 1 / 3 and 1 / 2 of the length of the pusher from the rear end of the pusher, in particular between 2 / 5 and 1 / 2 of the length of the pusher.

[0024] This bridge portion can extend about 1 / 3 to 1 / 4 from the front end of the push piece.This projection, particularly its apex, can be arranged on the back side of this bridge portion.

[0025] The projections can provide a space between them that, when in use, has a generally flared shape toward the skull, preferably a symmetrical shape. This shape can be flared in the sagittal plane, but can also be flared in other directions relative to the smooth curvature of the projections. This can help properly position the projections, for example, to help center the push piece relative to the floor of the mouth. Additionally or alternatively, the space can accommodate the subject's tissue; this flared shape can help guide the tissue and prevent excessive and / or asymmetrical pressure.

[0026] Each projection may have a base, and each projection having an apex may be located laterally outward from the corresponding base, arranged in the laterally outer half of the base (as viewed in the main axial direction), particularly within a range of about 1 / 4 or less of the sagittal cross-sectional width of the base, preferably within a range of about 1 / 5 to 1 / 10 of the sagittal cross-sectional width of the base. The legs of the U-shaped push piece may define the base, and the width of the legs may define the width of the base. This may strengthen the projection and / or may position at least the apex of the projection relatively laterally outward from the base so as to localize the applied force to the soft tissue of the submental triangle of the subject and achieve its displacement.

[0027] The pusher can include one or more connectors for operatively connecting the strap and the pusher, preferably at least partially reversibly connecting the strap and the pusher. This can facilitate one or more of manufacturing, transport, storage, and preferably cleaning (e.g., disinfecting and / or sterilizing the strap and the pusher, respectively). Additionally or alternatively, reversibly connecting the strap and the pusher can facilitate (preferably repeatedly) connecting and disconnecting the pusher and the strap, which can facilitate placement and / or adjustment of the pusher and / or the entire assembly on a subject, as well as removal from the subject.

[0028] The one or more connectors may comprise at least one hook and / or at least one loop for operatively engaging the drawstring. The hook and / or loop may be provided with a locating structure for at least a portion of the drawstring (e.g. at least one surface portion providing increased friction with the drawstring and being corrugated and toothed). The surface portion providing increased friction with the drawstring may comprise one or more of a roughened surface portion, a rubberised portion and / or a portion that interacts with at least a portion of the drawstring (e.g. wraps around at least a portion of the drawstring and / or clamps the drawstring). Each connector is preferably defined. Each leg may be provided with at least one of the one or more connectors.

[0029] The strap may be attached or attached, for example, by at least one of the one or more connectors mentioned above, so as to be arranged, at least in use, laterally adjacent the apex of the projection or each projection, and preferably for connecting and securing the strap to the push piece substantially symmetrically with respect to a sagittal plane passing through the apex of the respective laterally adjacent projections.

[0030] This can help to arrange and / or maintain push piece, band and experimenter in suitable relative position and / or direction.In addition or alternatively, this can help to provide suitable force direction, so that experimenter's internal soft tissue is pushed to the laryngeal mask in experimenter's airway.

[0031] This strap can comprise or be flexible band, particularly provide widened skull part.In addition or alternatively, this strap can comprise elastic part and / or substantially inelastic part, both can help to adjust the force and / or pressure of pushing piece to experimenter.

[0032] The assembly may include one or more silencers and / or sound generators for controlling the sound entering the subject's ears, which may be attached to a strap. This may help attenuate and / or mask noise from the environment (e.g., from one or more of an operating room, a surgical procedure, a treatment ward, etc.) to the subject. This may prevent auditory information (e.g., unpleasant sounds) from reaching the subject, and / or apply pleasant sounds to the subject. The strap may extend over the subject's ears when in use, which may help position the one or more silencers and / or sound generators.

[0033] The assembly may include a laryngeal mask.

[0034] Furthermore, in connection with the foregoing disclosure and any benefits discussed herein, there is provided a method of ventilating a subject, comprising: operably mounting a laryngeal mask in the airway of the subject; and providing the subject with a ventilation assembly as discussed herein, and arranging a pusher to displace soft tissue of the subject's mouth floor toward the subject's skull to push the subject's internal soft tissue toward the laryngeal mask in the subject's airway, for at least partially sealing the airway and preventing leakage along the laryngeal mask by pushing the soft tissue of the subject's mouth floor toward the subject's skull relative to the subject's mandible.

[0035] The method may include: operably installing the laryngeal mask in the airway of a subject; manually operably positioning a pusher on the floor of the subject's mouth and controlling the seal of the airway; and securing the pusher to the subject by connecting at least a portion of a strap to the pusher. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The above aspects, further details and benefits will be explained in more detail below in conjunction with several exemplary embodiments with reference to the accompanying drawings.

[0037] FIG1A is a partially schematic cross-sectional illustration of the neck region of a human body with a laryngeal mask inserted into an operative position, and also including a portion of a ventilation assembly disclosed herein;

[0038] FIG1B is a partial schematic cross-sectional view of the neck region of a human body taken along plane BB shown in FIG1A and also including a portion of a vent assembly disclosed herein;

[0039] FIG1C is a partial schematic cross-sectional view of the neck region of a human body taken along plane BB shown in FIG1A , and also including a portion of a vent assembly disclosed herein in an operative position;

[0040] FIG1D is a partial side view of a portion of a vent assembly disclosed herein;

[0041] FIG2 is a side view of a subject wearing a ventilation assembly as disclosed herein;

[0042] FIG3 is a front view of a subject wearing a ventilation assembly as disclosed herein;

[0043] FIG4 is a front view of a vent assembly disclosed herein;

[0044] 5A-5B are top and bottom perspective views of the push member, respectively;

[0045] 6A-6B are top and bottom views of the push member, respectively;

[0046] FIG7A is a top view from above along the sagittal plane;

[0047] FIG7B is a front view along the sagittal plane;

[0048] FIG8A is a posterior view from above along the sagittal plane;

[0049] FIG8B is a cross-sectional view along the coronal cross-sectional plane indicated by VIII in FIG6A and FIG6B ;

[0050] FIG9A is a lateral side view of the push member;

[0051] FIG9B is a cross-sectional view along the sagittal cross-sectional plane indicated by IX in FIG6A and FIG6B ;

[0052] 10A-10B illustrate one embodiment of a strap. DETAILED DESCRIPTION

[0053] It should be noted that the drawings are schematic and not necessarily drawn to scale, and that details not necessary for an understanding of the present invention may have been omitted. Terms such as "upward," "downward," "below," and "above" refer to the embodiments as they are oriented in the drawings, unless otherwise indicated. Furthermore, elements that are at least substantially identical or perform at least substantially identical functions are denoted by the same reference numerals, with alphabetic suffixes used to distinguish them where helpful.

[0054] Furthermore, unless otherwise indicated, terms such as "detachable" and "removably connectable" mean that the respective components can be disconnected substantially without damaging or destroying either component, and exclude, for example, structures where the components are integral (e.g., welded or integrally molded), but include structures where the components are attached by or as mating connectors, fasteners, releasable self-fastening features, etc. The verb "facilitate" means "to make easier and / or less complicated," rather than "to enable."

[0055] Figures 1A-1C are partial schematic cross-sectional views of the lower head and neck region of a person P or subject, taken along the sagittal plane AA (Figure 1A, with the plane indicated in Figures 1B and 1C) and the frontal plane BB (Figures 1B and 1C, with the plane indicated in Figure 1A). These figures (primarily Figure 1A) show the pharynx 1, larynx, and trachea 3 of the subject P, with the laryngeal mask 5 inserted into the operative position of the airway (nose and / or oro-pharynx-larynx-lung) of the subject P. The subject's nose 7, upper lip 9, lower lip 11, chin 13, floor of mouth 15, and throat 17 are discernible, as well as the back of the neck 19. Also discernible are the subject's palate 21, tongue 23, pharynx 1, epiglottis 25, hypopharynx 26, and esophagus 27, as well as the mandible 29 with teeth 30 and the hyoid bone 31. Jaw tissue 32 (particularly the gums) separates the soft tissue of the floor of mouth 15 from the soft tissue of the subject's cheeks and oral cavity. The soft tissue of the floor of the mouth 15 is primarily formed by the left and right submandibular triangles (trigonum submandibulare) and the submental triangle (trigonum submentale). A laryngeal mask 5 connected to a ventilation tube 33 is inserted into the hypopharynx 26 in a conventional manner and covers the opening of the trachea 3. The laryngeal mask 5 includes an inflatable cuff 35 for substantially sealing (the opening of) the trachea 3. Thus positioned and if properly fitted, the patient subject P can be forcefully ventilated via the tube 33 connected to the laryngeal mask 5.

[0056] To reduce or prevent leakage in the event that the mask 5 does not seal properly in the hypopharynx 26, a vent assembly 37 is provided, one embodiment of which is shown in Figures 2-4.

[0057] The ventilation assembly 37 includes a headband 39 and a pusher 41. Details of the pusher are shown in Figures 5A-9B. Note that all figures, particularly Figures 1A-4, are schematic and not drawn to scale, and that the ventilation assembly 37 is shown spaced from the subject's head for clarity; in operation, the assembly will be in close contact with the skin, and tissue displacement (see below) will be significantly smaller.

[0058] The strap 39 shown is formed as a single strap, but more complex straps can also be used. The strap 39 can be placed on the head H of the subject P to support the pusher 41 to press the floor of the mouth 15 of the subject P; see Figures 1A-1C and Figures 2-3. When in use (as shown in the figures), the pusher 41 includes two laterally adjacent protrusions 42 in the cranial direction. The pusher 41 is arranged to displace the soft tissue of the floor of the mouth 15 in the cranial direction relative to the mandible 29 of the subject P, see arrow F in Figures 1A-1C. The direction of the force is generally in the parasagittal plane, obliquely from the floor of the mouth 15 to the subject's ear relative to the coronal direction; the direction of the force is preferably through the introitus of the ear canal. However, in some cases, the direction of the force may span the posterior (dorsal) half of the temple in front of the ear canal (ventral side). Thus, when the laryngeal mask 5 is installed in the airway of a subject P as shown in FIG1A , the pusher 41 is arranged to push the internal soft tissue of the floor of the mouth 15 of the subject P, such as portions of the tongue 23 and / or epiglottis 25, toward the laryngeal mask 5 in the airway of the subject P without choking or otherwise impairing breathing of the subject P, and preferably without pressing the tongue toward the tube. As can be clearly seen in FIG1A-1C , due to the protrusion 42, the force F near the mandible, in the submandibular triangle, is locally greater than the force at or near the middle, in the submental triangle.

[0059] The force F is directed so that the subject's teeth 30 (in a normal, healthy individual of average anatomical shape) are aligned with a normal occlusal position in which the lower anterior teeth are in (i.e., dorsal to) but proximal to the upper anterior teeth; there is no "overbite." This effect and resulting position may be referred to as "mandibular thrust." It is desirable to prevent a so-called "chin lift" position in which the lower anterior teeth can pass over and lie in front of (i.e., ventral to) the upper anterior teeth.

[0060] The strap 39 comprises, here essentially formed as, a flexible member, such as a belt. In use, the strap 39 can be positioned generally around the subject's head H in the anatomical coronal plane, as shown. The strap 39 can be closed and can include one or more elastic portions. The strap 39 shown includes an optional fastener for adjusting the size of the strap 39, for example, adjusting the length of the flexible member, such as a hook-and-loop wrap fastener V, such as a fastener commonly known as "Velcro," in which case the hook side should preferably face outward, away from the subject's skin ( FIG. 4 ). However, the fastener can take any suitable form or combination, for example, including one or more of a buckle, clasp, button, slider, zipper, D-ring fastener, etc. In the strap shown, the strap can have varying widths, for example, including a wider portion 47 for placement on the top of the subject's head and narrower portions 43 , 45 that are connected to or have been connected to the pusher; see FIGS. 10A-10B .

[0061] As can be clearly seen from Figures 1A-4, the ventilation assembly requires very little space under the chin and does not interfere with access to the chest and / or neck area. For example, the assembly 37 (the pusher 41) can be arranged above the thyroid gland (cartillago thyroidea) (cranial), as shown in the figure, and may even be above the hyoid bone (cranial). Such an assembly also keeps the neck area available for (emergency) tracheotomy. As can be seen most clearly in Figures 4 and 5A-9B, the pusher (41) can be roughly U-shaped in the transverse direction, with a bridge portion (41B) on the front side (when in use: ventral VS - Figure 1D) and opposing legs 41L on the back side (when in use: dorsal DS - Figure 1D), each leg 41L including a protrusion 42. The protrusions have a vertex 42S. The protrusions are separated by a space S. Preferably, as shown in the figure, the pusher 41 is symmetrical with respect to the sagittal plane. Therefore, when in place below the subject's chin, a portion of the subject's throat, particularly the submental triangle, can be accommodated in the space S of the pusher 41 .

[0062] As best seen in Figures 1A, 5B, 6B, 8B, and 9B, the pusher 41 is hollow, accommodating an operator's finger OF in each protrusion 42 (illustrated schematically in Figure 8B). In particular, the pusher 41 shown is formed as a hollow shell, optionally single-walled and providing a continuous recess R. As an option, the pusher 41 has a substantially constant wall thickness (Figures 8B and 9B). However, one or more reinforcing ribs may be provided in the recess R; preferably, the pusher maintains its shape during normal use and operation, deforming less than 10%, preferably less than 5%, and more preferably less than 3% under load in proper use (operably supported by the strap and applying a force F to a degree that does not disrupt blood flow in the subject's tissue and / or otherwise injure the tissue) compared to an unloaded condition. By accommodating the operator's finger OF in one or more protrusions (42) and / or bridge (41B), placement and / or adjustment of the pusher 41 and the entire assembly can be simplified.

[0063] Furthermore, as best seen in the side views ( FIGS. 1A , 1D , and 9A and the cross-sectional view 9B ), the bridge portion 41B can have a relatively small height HB. Similarly, the bridge portion 41B can have a relatively short length LB in the sagittal plane (see FIG. 9B ), for example, on the anterior side of the pusher 41. Each leg 41L can form a protrusion 42 in a generally cranial direction relative to the bridge portion 41B, the protrusion having a height Hp greater than the bridge portion 41B and a total height Tp = Hp + HB.

[0064] The bridge portion 41B may extend from the front side of the pusher 41 by a length LB that is less than 1 / 2, for example less than 1 / 3 or between about 1 / 3 and 1 / 5, for example about 1 / 4, of the sagittal length Lp of the pusher 41. The protrusion 42, particularly its apex 42S, is disposed on the back side of the bridge portion 41B.

[0065] The protrusion 42 of the pusher 41, and preferably the entire pusher 41, is smooth and rounded, at least on the side facing the subject. The protrusion 42 may project generally upward (in use, toward the skull). The apex 42S may be located approximately 1 / 3 to 1 / 2 of the way from the dorsal side of the pusher 41, specifically between 2 / 5 and 1 / 2 of the way from the dorsal side. Here, it may be located approximately 1 / 2 to 2 / 3 of the way from the anterior / ventral side of the pusher 41, specifically between 1 / 2 and 3 / 5 of the way from the dorsal side.

[0066] As best seen in Figures 1B-1C and 7A-8B, projections 42 provide space S with a generally open shape toward the skull. Projections 42 have a generally smoothly outwardly curved inner side 42M and a generally steeply tapering side 42L. Each vertex 42S extends outwardly from the corresponding leg 41L by a length less than approximately 1 / 4 of the sagittal cross-sectional width of the leg 41L, preferably within a range of approximately 1 / 5 to 1 / 10 of the sagittal cross-sectional width of the leg 41L, as shown. For example, the width of the leg may be ab.

[0067] The smoothly curved shape of protrusion 42 can reduce localized pressure on the floor of the mouth and, dorsally, on the throat, and can reduce or prevent possible discomfort and / or complications associated with increased pressure, such as poor or stopped blood perfusion to tissue sections. It should also be noted that the relatively small thickness HB of bridge portion 41B of pusher 41 can reduce localized pressure on the mandible and the soft tissues anterior to the submental triangle and / or chin, thereby preventing possible related discomfort and / or complications. The combination of the U-shape and the relatively high protrusion apex helps provide localized increased pressure on the floor of the mouth, particularly in the submandibular triangle, and to a lesser extent in the submental triangle, while reducing or preventing increased pressure on the throat and airway.

[0068] In order to displace the soft tissue relative to the subject's mandible 29 (the angle and / or body), the pusher 41 is formed to at least partially fit within the subject's mandible 29, and in particular at least partially fit between the left and right angles or bodies of the subject's mandible 29, thereby deforming it according to the shape and deformability of the floor of the mouth 15 and the shape of the subject's mandible 29; see Figures 1B-1C.

[0069] As shown in the figure, the protruding height of the protrusion 42 of the pusher 41 can change continuously and smoothly and / or be consistent with the deformability of the floor of the mouth 15 relative to the mandible 29 (which narrows from the corner to the chin), thereby preventing excessive stress and / or pressure from being generated in the corresponding tissue parts, especially in each submandibular triangle.

[0070] It should also be noted that the pusher can occupy a very small volume below the floor of the mouth. The dimensions of the pusher 41, in particular the protruding height Hp and / or the back thickness T of the pusher D, may be selected so that the assembly, when in use, is positioned above (cranial to) the subject's thyroid gland, see, for example, Figures 1A, 3, 6-8.

[0071] The pusher may have a length L in the range of about 55-85 mm relative to the sagittal plane. B (See FIG9B ), preferably in the range of about 65-80 mm, most preferably in the range of about 70-75 mm. The bridge portion may have a length L in the sagittal plane in the range of about 10-35 mm. B (See FIG9B ), preferably in the range of about 15-30 mm, most preferably in the range of about 20-25 mm. The legs may have a width in the coronal plane in the range of about 20-35 mm (see FIG8B ), preferably in the range of about 25-30 mm. The opening angle α of the legs (see FIG6B ) may be in the range of about 35-50 degrees, preferably in the range of about 37-45 degrees, most preferably in the range of about 40-43 degrees (see FIG6A-6B ). The pusher may have an overall height Tp determined by the apex, and the bridge portion may have a bridge height H B , bridge height H B The ratio of H to the total height Tp can be about B :T P =1:3-2:3. For example, the bridge portion may have a bridge height H in the sagittal plane in the range of about 10-35 mm. B (See FIG. 9B ), preferably in the range of about 15-30 mm, most preferably in the range of about 20-25 mm.

[0072] The pusher can have an overall height Tp relative to the sagittal plane in the range of 20-45 mm, particularly in the range of 25-35 mm, and more particularly in the range of 30-35 mm. A taller (or "thicker") pusher may hinder contact with the subject's throat, and a shorter (or "thinner") pusher may hinder application and / or determination of appropriate pressure against the floor of the mouth.

[0073] The protrusion apex can have a height HP above the bridge (see Figures 9A-9B) ranging from approximately 5-25 mm, preferably approximately 7-20 mm, and most preferably approximately 10-15 mm. This height tends to provide tissue displacement suitable for most people to produce the desired sealing effect; a height in the range of 10-12 mm may be optimal. The full width at half maximum of one or each protrusion, in a plane passing through the apex along the longitudinal direction of the leg (see the dashed line in Figure 6B), can be in the range of approximately 35-55 mm, preferably approximately 40-50 mm, and the full width at half maximum in a coronal plane passing through the apex (see Figure 8B) can be in the range of approximately 20-30 mm, preferably approximately 23-27 mm, to accommodate an adult finger of a caregiver and prevent excessive localized force on the subject. The lateral spacing Sp of the apex 42S of the protrusion 42 of the pusher 41 can be in the range of approximately 65-80 mm, preferably approximately 70-75 mm. This width tends to be suitable for most adolescents and adults.

[0074] The pusher 41 may be provided as a separate component which may be placed against the subject P and held in place by the strap 39 , but preferably the pusher 41 is attached to the strap 39 .

[0075] As best seen in Figures 1D and 4-9B, the pusher is provided with connectors 51 and 53 on the lateral sides of the legs 41L for operatively connecting the strap 39 to the pusher. Here, one connector 51 is formed as a closed loop, and one connector 53 is formed as a hook (optionally including a barb 53b). However, two or more connectors may be identical; for example, the pusher may have two hooks similar to hook 53. Connectors 51 and 53 may optionally be provided with teeth 55 or corrugations to retain at least a portion of the strap 39 in a desired position. As shown in Figure 4, the strap 39 may be looped around connector 51. As shown, the teeth 55 may be disc-shaped, with a large radius in one direction, particularly in the circumferential direction, to conform to the wraparound shape, allowing for smooth sliding on the teeth, thereby facilitating adjustment of the strap length. Vertically, the teeth may have a small radius and / or be pointed to provide friction for the strap loop.

[0076] Thus, the connector comprises an axially elongated support portion for operatively engaging a strap circumferentially surrounding the support portion, the support portion being provided with a plurality of axial corrugations, such as crenels, forming circumferential circular teeth.

[0077] The strap 39 can be permanently or temporarily attached to the pusher 41. The connectors 51, 53 located on the steep sidewall 42L help provide a force F generally in the direction of the sidewall 42L. This helps direct the force F in the desired direction, primarily in the direction of the mandible (e.g., see Figures 1B-1C). It also helps prevent the pusher 41 from deforming during use.

[0078] In addition, the connectors 51, 53 can define a reference plane RP. In the embodiment shown, the reference plane RP is parallel to the bottom of the pusher 41. The connectors 51, 52 can be arranged as shown (see in particular FIG1D ) so that the strap is configured to provide forces that are substantially symmetrical in the sagittal plane relative to the vertex 42S and a section of the vertex 42S that is parallel to the reference plane RP. For example, FIG1D shows a centerline CL that is perpendicular to the section of the vertex 42S and the reference plane RP, and the strap (39) is arranged symmetrically about the centerline CL. This helps to guide the direction of the force F in the sagittal plane by biasing the strap more ventrally or dorsally around the subject's head, particularly in the case of a strap with a single strap, the direction of the force will generally be along the strap. A strap having a width in the range of about 20-35 mm, preferably in the range of about 25-30 mm, can help guide the pusher and prevent localized pressure on the subject's skin.

[0079] 10A and 10B , an exemplary embodiment of a headband 39 is shown, which may include a headband having relatively narrow ends 43, 45 and a widened portion 47 therebetween. A loop 57 may be provided at one end, which may be permanently attached to the pusher 41 or looped over a hook, such as hook 53. Additionally or alternatively, the end 43 may be provided with a closure 58, such as a wrap-around closure such as Velcro or other connector that allows for continuous adjustment of the length of the headband.

[0080] As shown schematically in FIG. 2 , as an option, one or more sound dampeners 57 and / or sound generators for controlling the sound entering the subject's ears may be provided to the strap 39 .

[0081] The present disclosure is not limited to the embodiments described above, which may be varied in numerous ways within the scope of the claims. For example, the pusher and / or strap may have different shapes. The relative sizes of the various components may vary. The strap and / or pusher may be associated with and / or connected to other devices; for example, the strap and / or pusher may support one or more sensors attached to and / or embedded in the strap and / or pusher.

[0082] Unless explicitly stated otherwise, elements and aspects discussed or associated with one particular embodiment may be combined with elements and aspects of other embodiments as appropriate.

Claims

1. A ventilation assembly (37) for use in ventilating a subject using a laryngeal mask (5), comprising a headband (39) and a push piece (41), characterized in that: The strap can be arranged on the head (H) of the subject to support the pusher to press the floor of the mouth (15) of the subject (P), wherein the pusher comprises laterally opposed projections so as to displace the soft tissues of the subject at the left and right submandibular triangles relative to the mandible (29) of the subject and the surrounding tissues of the subject (e.g., submandibular triangle) toward the skull when the laryngeal mask is installed in the airway of the subject and when the laryngeal mask is in the airway of the subject, Each protrusion is hollow, providing a recess configured to accommodate an operator's finger for placing the pusher and / or adjusting the pusher (41).

2. The vent assembly according to claim 1, wherein The push piece is generally U-shaped in the transverse direction, and includes a bridging portion (41B) located in the front (when in use: ventral) part, for accommodating the tissue of the subject in the submental triangle when in use and when the strap is operably supported on the subject (P), and transversely opposite legs (41L) extending backward (when in use: dorsal) from the bridging portion, the legs being located in the rear (when in use: dorsal) part and including the transversely opposite protrusions (42).

3. A vent assembly (37) according to any preceding claim, characterised in that The pusher is formed as a continuous hollow body, such as a shell and / or a monocoque, and / or wherein the pusher has a substantially constant thickness in a direction perpendicular to an outer surface of the pusher.

4. The breather assembly according to claim 2 or according to both claims 2 and 3, characterized in that The bridge and the protrusions provide a substantially continuous smooth surface, the bridge having a saddle shape.

5. A breather assembly (37) according to any preceding claim, characterised in that The protrusion has an apex, which, when in use, is located in a position range of about 1 / 3 to 1 / 2 of the length of the pusher from the rear end of the pusher, particularly between 2 / 5 to 1 / 2 of the length of the pusher from the rear end of the pusher.

6. A vent assembly (37) according to claim 2 or according to claim 2 and any preceding claim 3-5, characterized in that At least one of the following conditions is met: The bridge portion (41B) extends from the front end of the pusher to about 1 / 3 to 1 / 4; The protrusion (42), in particular the apex (42S) thereof, is arranged on the back side of the bridge portion (41B); And the projections (42) provide a space (S) therebetween, the space having a shape that is generally open toward the skull when in use.

7. A vent assembly (37) according to any preceding claim, characterised in that The pusher has a length (L) in the range of about 55-85 mm relative to the sagittal plane. B ), preferably in the range of about 65-80 mm, most preferably in the range of about 70-75 mm; and / or; the push piece has a total height (Tp) relative to the sagittal plane in the range of 20-45 mm, in particular in the range of 25-35 mm, more particularly in the range of 30-35 mm.

8. A vent assembly (37) according to any preceding claim, characterised in that Each protrusion (42) has a base, and each protrusion having an apex (42S) is located laterally outside the corresponding base, arranged in the laterally outer half of the base (as seen in the main axial direction), particularly in the range of about 1 / 4 or less of the sagittal cross-sectional width of the base, preferably in the range of about 1 / 5 to 1 / 10 of the sagittal cross-sectional width of the base.

9. A vent assembly (37) according to any preceding claim, characterised in that One or more connectors are included for operatively connecting the strap and the pusher, preferably at least partially reversibly connecting the strap and the pusher.

10. The ventilation assembly (37) according to claim 9, characterized in that The one or more connectors include at least one hook and / or at least one loop for operatively engaging the strap.

11. The ventilation assembly (37) according to claim 10, characterized in that Said at least one hook and / or loop comprises an axially elongated support portion for operatively engaging said belt circumferentially surrounding said support portion, said support portion being provided with a plurality of axial corrugations, such as crenels, forming circumferential circular teeth.

12. A vent assembly (37) according to any preceding claim, characterised in that The strap can be attached or has been attached (for example, by at least one of the one or more connectors specified in claims 10 or 11) so as to be arranged, at least in use, in the transverse vicinity of the apex of the protrusion or each protrusion (42), and is preferably used to connect and secure the strap to the push piece substantially symmetrically relative to a sagittal plane passing through the apex of the respective protrusion.

13. A breather assembly (37) according to any preceding claim, characterised in that The strap comprises or is a flexible strap, in particular providing a widened skull portion.

14. A vent assembly (37) according to any preceding claim, characterised in that One or more mufflers and / or sound generators are included for controlling the sound entering the subject's ears.

15. An assembly comprising a ventilation assembly (37) according to any preceding claim and a laryngeal mask (5).

16. A method of ventilating a subject (P), comprising: operably mounting a laryngeal mask (5) in the airway of the subject; as well as providing the subject (P) with a ventilation assembly (37) according to any one of claims 1 to 14; as well as The pusher (41) is arranged to displace the soft tissue of the floor of the mouth (15) of the subject toward the skull of the subject to push the internal soft tissue of the subject toward the laryngeal mask in the airway of the subject, and is used to at least partially seal the airway and prevent leakage along the laryngeal mask by pushing the soft tissue of the floor of the mouth (15) of the subject toward the skull of the subject relative to the mandible (29) of the subject.

17. The method according to claim 16, comprising: operably mounting a laryngeal mask (5) in the airway of the subject; manually operatively placing the pusher (41) on the floor of the subject's mouth and controlling the sealing of the airway; The pusher is secured to the subject by connecting at least a portion of the strap to the pusher.

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