Ventilatory assistance device

Abstract

An assembly (37) for use in ventilating a subject using a laryngeal mask (5) comprises a head-mounted harness (39) and a pusher (41). The harness is arrangeable on the subject's head (H) to support the pusher to press against the subject's (P) floor of the mouth (15). The pusher comprises laterally opposite protrusions to displace, in use and with the harness operatively supported on the subject (P), the subject's soft tissue at the left and right submandibular trigonum relative to the subject's mandible (29) and the subject's surrounding tissue (e.g. submental trigonum) in a cranial direction for pushing the subject's internal soft tissue towards the laryngeal mask in the subject's airway when the laryngeal mask is installed in the subject's airway. Each protrusion or the entire pusher is hollow, providing a recess for accommodating an operator's finger.

Description

Technical Field

[0001] This disclosure relates to a headband, and more particularly to a headband for use in medical procedures when a laryngeal mask is used to ventilate a subject. Background Technology

[0002] Subjects unable to breathe normally, such as those injured and / or sedated, may receive mechanical ventilation. Intubation is a well-known technique for forced ventilation. Forced ventilation using a laryngeal mask airway (LMA) is also well-established and is generally preferred over intubation due to its less invasive nature. Various aspects of LMAs are disclosed, for example, in WO 2012 / 024728. Although LMAs are developed to provide an effective seal against the larynx, this seal may not be perfect, and air leakage may persist, for example, due to differences in patient anatomy relative to the shape and size of the available mask. Sedation and muscle relaxation may cause or exacerbate such leakage. Such leakage 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 ambient air. Therefore, such leakage should be prevented.

[0003] In practice, if a leak is found in the laryngeal mask airway and persists, practitioners may tend to use a larger size (i.e., an enlarged size) after repeated reuse. However, if the leak persists even after this and / or if the larger laryngeal mask airway is not suitable, intubation will eventually be used.

[0004] Therefore, it is desirable to prevent such leaks and / or increase the likelihood of effective use of laryngeal masks.

[0005] GB 2 267 034 discloses a laryngeal mask airway clamp, wherein the laryngeal mask airway device is clamped in place by a clamping member that engages with the patient's neck relative to 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 larynx, which may interfere with contact with the airway and / or treatment of the patient.

[0006] Furthermore, it should be noted that several devices are known for establishing and maintaining a subject's mandible or jawbone in a desired position relative to the maxilla, but these devices are unrelated to and / or incompatible with laryngeal masks (see also below). For example, US2018 / 0008452 relates to a device that forces the mouth to close during sleep to reduce snoring and / or treat sleep disorders such as sleep apnea. In one aspect, the device includes a jaw block that is fixed below the user's chin and also contacts the clavicular region of the upper chest. In another aspect, a device of the present invention includes a jaw block combined with a continuous positive airway pressure (CPAP) mask and headband for use with a CPAP system. The CPAP mask is worn on the user's face, contrasting with a laryngeal mask inserted into the user's larynx.

[0007] It is important to note that several devices are known for establishing and maintaining the subject's mandible or mandibular bone in the desired position relative to the maxilla. These devices are configured and designed to overcome airway obstruction, rather than compressing the airway for a tight seal 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 jaw forward from the patient's chest to allow the patient to breathe freely during sedation or sleep. Their operation depends on the patient's posture and (in)mobility.

[0009] US2010 / 0294284 discloses devices, systems, and methods for restraining and / or supporting structures along the airway by wearing a support collar. This may impede contact with the throat and / or restrict the wearer's mobility.

[0010] US2007 / 0079832 and US2015 / 0164726 are frames that are installed near a patient's head to assist with breathing. These devices are configured to push the patient's jaw forward to allow the patient to breathe freely during sedation or sleep.

[0011] US 7,124,758 discloses a device for treating snoring and obstructive sleep apnea. The device in US 7,124,758 includes 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 user's head, then wrap around the back of the neck, cross under the chin, and connect back to the front of the headband. When in use, the device maintains sufficient tension to keep the user's jaw locked together, with the lower front teeth contacting the upper front teeth, thereby overcoming airway obstruction, relieving obstructive sleep apnea, and reducing its associated incidence.

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

[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 headband is positioned on the subject's head (H) to support the pusher pressing against the floor of the subject's mouth (15). The pusher is positioned to displace the soft tissue of the floor of the mouth relative to the subject's mandible (29) toward the skull 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] Despite its excellent performance, further improvements to this type of component are still expected. Summary of the Invention

[0015] In view of the above, this article provides a ventilation assembly and a headband.

[0016] Specifically, a ventilation assembly for use in ventilating a subject using a laryngeal mask airway is provided, comprising a headband and a pusher. The headband is positioned on the subject's head to support the pusher for pressing against the subject's floor of mouth. The pusher includes laterally opposing protrusions to, during use and with the headband operably supported on the subject, displace soft tissue in the left and right trigonum submandibulare relative to the subject's mandible and surrounding tissues (e.g., the trigonum submentale) toward the skull, for pushing 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 receiving the operator's fingers.

[0017] This facilitates the manipulation and placement of the pusher. Caregivers such as doctors and nurses are trained to provide care to subjects based on touch and biofeedback; by inserting one or more fingers into the protrusion, caregivers can position the pusher appropriately on the floor of the subject's mouth and adjust the pressure to displace the soft tissue inside the subject's mouth. This manipulation is particularly aided by providing a recess on one side of the bottom (in use: the caudal side) of the pusher.

[0018] The pusher may be generally U-shaped in the transverse direction, including a bridging portion in the front (in use: ventral) portion for accommodating tissue of the subject in the submental triangle when in use and with the strap operably supported on the subject, and a transversely opposing leg (41L) extending rearward (in use: dorsal) from the bridging portion, the leg being in the rear (in use: dorsal) portion and including transversely opposing protrusions.

[0019] This can help in the placement and / or orientation of pushers and protrusions relative to the mandible.

[0020] The ejector can be formed as a continuous hollow body, such as a shell and / or a rigid shell structure. This can provide a robust ejector that resists deformation and / or can facilitate the manufacture of the ejector, for example, through molding techniques and / or sheet metal forming techniques.

[0021] The pusher can have a substantially constant thickness in a direction perpendicular to its outer surface. This can aid in pusher positioning; and / or, by enabling caregivers to “perceive” the subject through the pusher; and / or, by providing a constant distance between the caregiver’s finger on one side of the pusher and the subject and their anatomy on the other side of the pusher’s thickness, without altering the spacing between the caregiver’s finger and the subject / subject features due to variations in pusher thickness.

[0022] The bridging portion and protrusion can provide a substantially continuous, smooth external (subject-facing / contacting subject, during use) surface. The bridging portion has a saddle shape to help prevent local pressure variations, particularly excessive pressure that could damage the subject's skin and / or underlying tissues (e.g., providing excessive local pressure reduces or blocks 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 buildup.

[0023] The protrusion may have a vertex, which, in use, is located in a position between approximately 1 / 3 and 1 / 2 of the pusher length from the rear end of the pusher, particularly between 2 / 5 and 1 / 2 of the pusher length.

[0024] The bridging portion can extend from the front end of the pusher by about 1 / 3 to 1 / 4. The protrusion, especially its apex, can be arranged on the back side of the bridging portion.

[0025] These protrusions can provide a space between them, which, when in use, has a shape that generally opens toward the skull, preferably a symmetrical shape. This shape can open in the sagittal plane, but can also open in other directions related to the smooth curvature of the protrusion. This can help to properly position the protrusion, for example, to help the pusher be centered relative to the floor of the mouth. Additionally or alternatively, the space can accommodate the subject's tissue; the opening shape can help guide the tissue and prevent excessive and / or asymmetrical pressure.

[0026] Each protrusion may have a base, and each protrusion with a apex may be located laterally outside the corresponding base, arranged in the lateral outer half of the base (as seen in the main axial direction), particularly within about 1 / 4 or less of the sagittal cross-sectional width of the base, preferably within about 1 / 5 to 1 / 10 of the sagittal cross-sectional width of the base. Legs of the U-shaped pusher may define the base, and the width of the legs may define the width of the base. This may reinforce the protrusion and / or position at least the apex of the protrusion relatively laterally outward on the base to direct the applied force to the soft tissue of the subject's submental triangle and achieve its displacement.

[0027] The pusher may 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 the processes of manufacturing, transport, and storage, and preferably facilitates cleaning (e.g., sterilizing and / or disinfecting the strap and the pusher separately). Additionally or optionally, reversibly connecting the strap and the pusher can facilitate (preferably repeatedly) connecting and disconnecting the pusher and the strap, which can facilitate the placement and / or adjustment of the pusher and / or the entire assembly on the subject, as well as its removal from the subject.

[0028] The one or more connectors may include at least one hook and / or at least one loop for operatively engaging a strap. The hook and / or loop may have a positioning structure for at least a portion of the strap (e.g., at least one corrugated and serrated surface portion providing increased friction with the strap). The surface portion providing increased friction with the strap may include one or more of a roughened surface portion, a rubberized portion, and / or a portion interacting with at least a portion of the strap (e.g., at least a portion wound around the strap and / or clamping the strap). Each connector is preferably defined. Each leg may have at least one of the one or more connectors.

[0029] The strap may be attached or has been attached, for example, by at least one of the above-described connectors, to be arranged at least in the lateral proximity of the apex of the protrusion or each of the protrusions during use, and is preferably used to connect and secure the strap substantially symmetrically to the pusher with respect to the sagittal plane passing through the apex of the respective laterally adjacent protrusion.

[0030] This can help position and / or maintain the pusher, straps, and subject in the proper relative position and / or orientation. Additionally or alternatively, this can help provide the appropriate force direction to push the subject's internal soft tissue toward the laryngeal mask in the subject's airway.

[0031] The band may include or be a flexible band, particularly providing a widened portion of the skull. Additionally or optionally, the band may include an elastic portion and / or a substantially inelastic portion, both of which can help regulate the force and / or pressure exerted by the pusher on the subject.

[0032] This component may include one or more silencers and / or sound generators for controlling the sound entering a subject's ear, which may be attached to a strap. This can help attenuate and / or mask noise from the environment (e.g., from one or more of the operating room, surgical site, treatment room, etc.) to the subject. This can prevent auditory information (e.g., unpleasant sounds) from reaching the subject and / or impose pleasant sounds on the subject. The strap may extend to the subject's ear during use, which can help locate the one or more silencers and / or sound generators.

[0033] This component may include a laryngeal mask.

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

[0035] The method may include: operably installing a laryngeal mask in the airway of a subject; manually operably positioning a pusher on the floor of the subject's mouth and controlling the sealing of the airway; and securing the pusher to the subject by attaching at least a portion of a strap to the pusher. Attached Figure Description

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

[0037] Figure 1A It is a partial schematic cross-sectional view of the neck region of a human body with a laryngeal mask inserted into the operating position, and also includes a portion of the ventilation assembly disclosed herein;

[0038] Figure 1B It is along Figure 1AThe schematic cross-sectional view of the human neck region of the planar BB shown herein also includes a portion of the ventilation assembly disclosed herein;

[0039] Figure 1C It is along Figure 1A The schematic cross-sectional view of the human neck region of the planar BB shown herein also includes a portion of the ventilation assembly in the operating position disclosed herein;

[0040] Figure 1D This is a partial side view of a part of the ventilation assembly disclosed in this article;

[0041] Figure 2 This is a side view of a subject wearing the ventilation device disclosed in this article;

[0042] Figure 3 This is a front view of a subject wearing the ventilation device disclosed in this article;

[0043] Figure 4 This is a front view of the ventilation assembly disclosed in this article;

[0044] Figures 5A-5B These are the top and bottom perspective views of the pusher component, respectively.

[0045] Figures 6A-6B These are the top and bottom views of the pusher component, respectively.

[0046] Figure 7A It is a top view along the sagittal plane from above;

[0047] Figure 7B This is a front view along the sagittal plane;

[0048] Figure 8A It is a rear view from above along the sagittal plane;

[0049] Figure 8B It is along Figure 6A , 6B A cross-sectional view of the coronal cross-sectional plane indicated by VIII;

[0050] Figure 9A This is a side view of the pusher component;

[0051] Figure 9B It is along Figure 6A , 6B A cross-sectional view of the sagittal cross-sectional plane indicated by IX;

[0052] Figures 10A-10B An embodiment of the strap is shown. Detailed Implementation

[0053] It should be noted that the accompanying drawings are schematic and not necessarily drawn to scale, and details that are not essential for understanding the invention may have been omitted. The terms "upward," "downward," "below," "above," etc., refer to embodiments in the directions shown in the drawings, unless otherwise stated. Furthermore, elements that are at least substantially the same or perform at least substantially the same function are indicated by the same reference numerals and may be distinguished by letter suffixes where helpful.

[0054] Furthermore, unless otherwise stated, terms such as “detachable” and “removably connected” mean that the corresponding components can be disconnected substantially without damage or destruction of either component. This excludes structures where components are integral (e.g., welded or integrally molded), but includes structures where components are attached by or as mating connectors, fasteners, releasable self-fastening features, etc. The verb “helps” means “to make easier and / or less complicated”, not “to enable.”

[0055] Figure 1A-1C It is based on the sagittal plane AA ( Figure 1A The plane is Figure 1B and Figure 1C (middle indicator) and frontal BB ( Figure 1B , Figure 1C The plane is Figure 1A These figures (primarily) are schematic cross-sectional views of the lower head and neck region of a person or subject (as indicated in the diagram). Figure 1A The diagram shows the pharynx 1, larynx, and trachea 3 of subject P, with the laryngeal mask 5 inserted into the subject P's airway (nose and / or oropharynx-larynx-lung) in its operational position. Identifiable are the subject's nose 7, upper lip 9, lower lip 11, chin 13, floor of mouth 15, and larynx 17, as well as the posterior neck 19. Also identifiable are the subject's palate 21, tongue 23, pharynx 1, epiglottis 25, laryngopharynx 26, and esophagus 27, as well as the mandible 29 with teeth 30 and hyoid bone 31. The jaw tissues 32 (particularly the gums) separate the soft tissues of the floor of mouth 15 from the soft tissues of the subject's cheeks and oral cavity. The soft tissues of the floor of mouth 15 are primarily formed by the left and right submandibulare and submental triangles. The laryngeal mask 5, connected to the airway 33, is inserted into the laryngopharynx 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. Positioned thus and if properly fitted, the patient subject P can be forcibly ventilated via a tube 33 connected to the laryngeal mask 5.

[0056] To reduce or prevent leakage in case the mask 5 does not seal properly in the throat 26, a ventilation assembly 37 is provided, one embodiment of which is shown in Figure 2-4 middle.

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

[0058] The strap 39 shown is formed as a single strip, but more complex straps may also be used. The strap 39 can be positioned on the head H of the subject P to support the pusher 41 pressing against the floor of the subject P's mouth 15; see also Figure 1A-1C and Figure 2-3 The pusher 41, in use (as shown), includes two laterally adjacent protrusions 42 in the skull direction. The pusher 41 is arranged to displace the soft tissue of the floor of the mouth 15 relative to the mandible 29 of the subject P in the skull direction. See [reference needed]. Figure 1A-1C Arrow F in the diagram. The direction of this force is generally in the parasagittal plane, inclined approximately from the floor of the mouth 15 toward the subject's ear relative to the coronal direction; this direction of force preferably passes through the introitus of the ear canal. However, in some cases, this direction of force may cross the posterior (dorsal) half of the anterior (ventral) temple of the ear canal. Therefore, when the laryngeal mask 5 is as... Figure 1A When installed in the airway of subject P, the pusher 41 is arranged to push the soft tissue inside the floor of the mouth 15 of subject P, such as a portion of the tongue 23 and / or epiglottis 25, toward the laryngeal mask 5 in the airway of subject P without causing subject P to suffocate or otherwise impair breathing, and preferably without pressing the tongue against the endotracheal tube. Figure 1A-1C It can be clearly seen that, due to the protrusion 42, the force F near the mandible and in the submandibular triangle is locally greater than the force in the middle, in the submental triangle or nearby.

[0059] The direction of force F allows the subject's teeth 30 (in normal healthy individuals with average anatomy) to align with the lower anterior teeth in (i.e., dorsally) but close to the upper anterior teeth in a normal occlusal position; there is no "overbite". This effect and the resulting position can be referred to as "mandibular thrust". It is best to prevent the so-called "chin-lift" position, in which the lower anterior teeth can cross over and lie in front of the upper anterior teeth (i.e., ventrally).

[0060] The strap 39 comprises, here substantially formed, a flexible member, such as a band. When in use, the strap 39 can be, as shown, generally encircling the subject's head H within the anatomical coronal plane. 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, length adjustment of the flexible member, such as a hook-and-loop fastener V, such as a fastener commonly referred to as "Velcro," in which case the hook side should preferably face outwards and away from the subject's skin. Figure 4 However, the fasteners can take any suitable form or combination, including, for example, one or more of the following: buckles, snaps, buttons, sliders, zippers, D-ring fasteners, etc. In the illustrated strap, the strap can have varying widths, for example, including a wider portion 47 for placement on the subject's head and narrower portions 43, 45 connected to or already connected to the pusher; see also... Figures 10A-10B .

[0061] from Figure 1A-4 As can be clearly seen, this ventilation component requires very little space below the chin and does not interfere with contact with the chest and / or neck region. For example, the component 37 (the pusher 41) can be positioned above (cranially) the thyroid gland, as shown, and possibly even above (cranially) the hyoid bone. Such a component also keeps the neck region available for (emergency) tracheotomy. Figure 4 and Figure 5A-9B The most clearly visible part is the pusher (41), which can be roughly U-shaped in the transverse direction, on the front side (when in use: ventral side VS- Figure 1D It has a bridging part (41B) on the rear side (in use: rear side DS- Figure 1D The pusher 41 has opposing legs 41L, each leg 41L including a protrusion 42. The protrusion has a apex 42S. The protrusions are separated by spaces S. Preferably, as shown, the pusher 41 is symmetrical with respect to the sagittal plane. Thus, when in place below the subject's mandible, a portion of the subject's throat, particularly the submental triangle, can be accommodated within the spaces S of the pusher 41.

[0062] exist Figure 1A , 5B The most notable features in models 6B, 8B, and 9B are that the pusher 41 is hollow, with each protrusion 42 accommodating the operator's finger OF (in...). Figure 8B (Illustrated schematically). In particular, the pusher 41 shown is formed as a hollow shell, optionally with a single wall and providing a continuous recess R. Alternatively, the pusher 41 has a substantially constant wall thickness ( Figure 8B , 9BHowever, one or more reinforcing ribs may be provided in the recess R; preferably, the pusher maintains its shape during normal use and operation, and under load of appropriate use (operably supported by a strap and subjected to a force F to the extent that it does not interrupt blood flow in the subject's tissue and / or otherwise damage the tissue), the deformation is less than 10%, preferably less than 5%, more preferably less than 3%, compared to the unloaded condition. The placement and / or adjustment of the pusher 41 and the entire assembly can be simplified by accommodating the operator's fingers OF in one or more protrusions (42) and / or bridging portions (41B).

[0063] In addition, such as the side view ( Figure 1A , 1D and 9A and cross-sectional view Figure 9B As best seen in the sagittal plane, the bridging portion 41B can have a smaller height HB. Similarly, the bridging portion 41B can have a shorter length LB in the sagittal plane (see [reference]). Figure 9B For example, the front side of the pusher 41. Each leg 41L may form a protrusion 42 in the general skull direction relative to the bridging portion 41B, the protrusion having a height Hp above the bridging portion 41B and a total height Tp = Hp + HB.

[0064] The bridging portion 41B can extend from the front side of the pusher 41 by a length LB, which is less than 1 / 2 of the sagittal length Lp of the pusher 41, for example less than 1 / 3 or between about 1 / 3 and 1 / 5, for example about 1 / 4. The protrusion 42, in particular its apex 42S, is arranged on the back side of the bridging 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: towards the skull). The apex 42S may be located at approximately 1 / 3 to 1 / 2 of the distance from the dorsal side of the pusher 41, particularly between 2 / 5 and 1 / 2 of the distance from the dorsal side, specifically between approximately 1 / 2 and 2 / 3 of the distance from the anterior / ventral side of the pusher 41, particularly between 1 / 2 and 3 / 5 of the distance from the dorsal side.

[0066] exist Figure 1B-1C As most evident in 7A-8B, protrusion 42 provides the space S with a shape that generally opens towards the skull. Protrusion 42 has an inner side 42M that curves outward in a generally smooth manner and a generally steep side 42L. The length by which each vertex 42S extends outward on the corresponding leg 41L is less than about 1 / 4 of the width of the sagittal cross-section of the leg 41L, preferably in the range of about 1 / 5 to 1 / 10 of the width of the sagittal cross-section of the leg 41L, as shown in the figure. For example, the width of the leg can be ab.

[0067] The smooth, curved shape of the protrusion 42 reduces localized pressure on the floor of the mouth and on the larynx dorsally, and can reduce or prevent potential discomfort and / or complications associated with increased pressure, such as poor or absent blood perfusion to tissue areas. It should also be noted that the relatively small thickness HB of the bridging portion 41B of the pusher 41 reduces localized pressure on the mandible and the soft tissue anterior to the submental triangle and / or chin, thereby preventing potential related discomfort and / or complications. The combination of the U-shape and the relatively high apex of the protrusion helps to provide locally increased pressure on the floor of the mouth, particularly at the submandibular triangle, while being less pronounced at the submental triangle, while reducing or preventing increased pressure on the larynx and airway.

[0068] To displace soft tissue relative to the angles and / or body of the subject's mandible 29, the pusher 41 is formed to at least partially fit within the subject's mandible 29, particularly at least partially between the left and right angles or body 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 also Figure 1B-1C .

[0069] As shown in the figure, the protrusion height of the protrusion 42 of the pusher 41 can be continuously and smoothly varied and / or 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 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 bottom of the opening. The dimensions of the pusher 41, especially its protrusion height Hp and / or back thickness T, are important considerations. D This can be selected so that the component is positioned above (cranially) the subject's thyroid gland during use, for example, see [link to relevant documentation]. Figure 1A , 3 6-8.

[0071] The pusher can have a length L in the range of approximately 55-85 mm relative to the sagittal plane. B (see Figure 9B The length of the bridging portion is preferably in the range of about 65-80 mm, and most preferably in the range of about 70-75 mm. The bridging portion can have a length L in the sagittal plane in the range of about 10-35 mm. B (see Figure 9B The width of the leg is preferably in the range of about 15-30 mm, and most preferably in the range of about 20-25 mm. The leg may have a width in the coronal plane in the range of about 20-35 mm (see [reference]). Figure 8B The preferred range is approximately 25-30 mm. The outrigger's opening angle α (see...) Figure 6BThe temperature can be in the range of approximately 35-50 degrees, preferably in the range of approximately 37-45 degrees, and most preferably in the range of approximately 40-43 degrees (see [reference]). Figures 6A-6B The pusher can have a total height Tp determined by the vertex, and the bridging part has a bridging height H. B Bridge height H B The ratio to the total height Tp can be approximately H. B :T P =In the range of 1:3 to 2:3. For example, the bridging portion can have a bridging height H in the sagittal plane in the range of approximately 10-35 mm. B (see Figure 9B The preferred range is about 15-30 mm, and the most preferred range is about 20-25 mm.

[0072] The thruster may have a total height Tp relative to the sagittal plane in the range of 20-45 mm, particularly in the range of 25-35 mm, and even more particularly in the range of 30-35 mm. A taller (or “thicker”) thruster may impede contact with the subject’s throat, while a lower (or “thinner”) thruster may hinder the application and / or determination of appropriate pressure on the floor of the mouth.

[0073] The protruding apex can have a height HP higher than the bridging portion (see...) Figures 9A-9B The height ranges from approximately 5-25 mm, preferably from approximately 7-20 mm, and most preferably from approximately 10-15 mm. Such a height tends to provide suitable tissue displacement for most people to achieve the desired sealing effect; a height in the range of 10-12 mm is likely optimal. One or each protrusion is in a plane passing through the apex, along the longitudinal direction of the leg (see...). Figure 6B The full width at half maximum (FWHM) of the dashed line (in the diagram) can be in the range of approximately 35-55 mm, preferably in the range of approximately 40-50 mm, and in the coronal plane passing through the vertex (see... Figure 8B The half-height and full width of the pusher 41 can be in the range of about 20-30 mm, preferably about 23-27 mm, to accommodate the adult fingers of caregivers and prevent excessive local force from being applied to the subject. The lateral spacing Sp of the apexes 42S of the protrusions 42 of the pusher 41 can be in the range of about 65-80 mm, preferably about 70-75 mm. Such a width tends to fit most adolescents and adults.

[0074] The pusher 41 can be provided as a separate component that can rest against the subject P and be secured in place by the strap 39, but preferably, the pusher 41 is attached to the strap 39.

[0075] exist Figure 1D , 4As can be seen most clearly in -9B, the pusher has connectors 51 and 53 on the lateral outer side of the leg 41L for operably connecting the strap 39 and the pusher. Here, one connector 51 is formed as a closed loop, and one connector 53 is formed as a hook (optionally including barbs 53b). However, two or more connectors can be identical; for example, the pusher can have two hooks like hook 53. Connectors 51 and 53 may optionally have teeth 55 or corrugations, etc., to hold at least a portion of the strap 39 in a desired position. Figure 4 As can be seen, the strap 39 can be wrapped around the connector 51. The teeth 55 can be disc-shaped, as shown, and circular with a large radius in one direction, particularly in the circumferential direction, to conform to the winding, so as to allow smooth sliding on the teeth, thereby facilitating the adjustment of the strap length. In the vertical direction, the teeth can have a small radius and / or be sharp to provide friction for the strap loop.

[0076] Therefore, the connector includes a support portion extending along an axis for operably engaging a strap circumferentially surrounding the support portion, the support portion having multiple axial corrugations, such as notches, forming circumferential circular teeth.

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

[0078] Furthermore, connectors 51 and 53 may define a reference plane RP. In the illustrated embodiment, the reference plane RP is parallel to the bottom of pusher 41. Connectors 51 and 52 may be as shown in the figure (see in particular). Figure 1D The bands are arranged such that they are configured to provide forces substantially symmetrical in the sagittal plane relative to the tangent of vertex 42S and parallel to the reference plane RP. For example, in Figure 1D The diagram shows a centerline CL, which is perpendicular to the sectional plane of vertex 42S and the reference plane RP, and the bands (39) are arranged symmetrically around the centerline CL. This helps to guide the direction of force F in the sagittal plane by directing the bands more ventrally or dorsally around the subject's head, especially in the case of bands with a single strip, where the force direction will generally be along that strip. Bands with 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 local pressure on the subject's skin.

[0079] exist Figure 10A , 10BThe image shows an exemplary embodiment of a headband 39, which may provide 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 a pusher 41 or fitted onto a hook (e.g., hook 53). Additionally or alternatively, end 43 may be provided with a closure 58, for example, a wrap-around closure such as Velcro or other connector that allows for continuous adjustment of the headband length.

[0080] exist Figure 2 As illustrated, one or more silencers 57 and / or sound generators for controlling the sound entering the subject's ear can be provided to the strap 39, as an alternative.

[0081] This disclosure is not limited to the embodiments described above, which may vary in various ways within the scope of the claims. For example, the pusher and / or strap may have different shapes. The relative dimensions of the components may differ. 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 a particular embodiment may be appropriately combined with elements and aspects of other embodiments.

Claims

1. A ventilation assembly (37) for use in ventilating a subject using a laryngeal mask (5), comprising a headband (39) and a pusher (41), characterized in that, The strap can be positioned on the subject's head (H) to support the pusher to press against the subject's (P) floor of mouth (15). The pusher (41) is generally U-shaped in the transverse direction and includes a bridging portion (41B) in the front portion for accommodating the subject’s tissue at the submental triangle when in use and when the strap is operably supported on the subject (P), and a transversely opposing leg (41L) extending rearward from the bridging portion, the leg being located in the rear portion. The outrigger (41L) includes laterally opposing protrusions (42) in the direction of the skull during use, so as to displace the soft tissue of the subject at the left and right submandibular triangles relative to the subject's mandible (29) and the subject's surrounding tissues in the direction of the skull during use and while operably supported on the subject (P) by the straps, for pushing the subject's internal soft tissue toward the laryngeal mask (5) in the subject's airway when the laryngeal mask (5) is installed in the subject's airway. Each protrusion (42) is hollow and has a recess (R) on the bottom side of the pusher to accommodate the operator's fingers, so as to facilitate the operation and placement of the pusher (41).

2. The ventilation assembly (37) according to claim 1, characterized in that, The surrounding tissue of the subject is the subject's submental triangle.

3. The ventilation assembly (37) according to claim 1, characterized in that, The pusher is formed as a continuous hollow body, and / or the pusher has a substantially constant thickness in a direction perpendicular to the outer surface of the pusher.

4. The ventilation assembly (37) according to claim 3, characterized in that, The continuous hollow body is a shell.

5. The ventilation assembly (37) according to claim 3, characterized in that, The continuous hollow body has a hard-shell structure.

6. The ventilation assembly according to claim 1 or 2, characterized in that, The bridging portion and the protrusion provide a substantially continuous smooth surface, and the bridging portion has a saddle shape.

7. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The protrusion has a vertex, which, in use, is located within a range of 1 / 3 to 1 / 2 of the length of the pusher from its rear end.

8. The ventilation assembly (37) according to claim 7, characterized in that, In use, the vertex is located between 2 / 5 and 1 / 2 of the length of the pusher from its rear end.

9. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, At least one of the following conditions must be met: The bridging portion (41B) extends 1 / 3 to 1 / 4 from the front end of the pusher; The protrusion (42) is arranged on the back side of the bridging portion (41B); The protrusion (42) provides a space (S) therebetween, which has a shape that generally opens toward the skull when in use.

10. The ventilation assembly (37) according to claim 9, characterized in that, At least one of the following conditions must be met: The bridging portion (41B) extends 1 / 3 to 1 / 4 from the front end of the pusher; The apex (42S) of the protrusion (42) is arranged on the back side of the bridging portion (41B); The protrusion (42) provides a space (S) therebetween, which has a shape that generally opens toward the skull when in use.

11. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The pusher has a length (L) in the range of 55-85 mm relative to the sagittal plane. B ); and / or; the pusher has a total height (Tp) within the range of 20-45 mm relative to the sagittal plane.

12. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The pusher has a length (L) in the range of 65-80 mm relative to the sagittal plane. B ); and / or, the pusher has a total height (Tp) relative to the sagittal plane in the range of 25-35 mm.

13. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The pusher has a length (L) in the range of 70-75 mm relative to the sagittal plane. B ); and / or, the pusher has a total height (Tp) in the range of 30-35 mm relative to the sagittal plane.

14. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, Each protrusion (42) has a base, and each protrusion with a vertex (42S) is located on the lateral outer side of the corresponding base and arranged on the lateral outer half of the base.

15. The ventilation assembly (37) according to claim 14, characterized in that, Each of the protrusions having a vertex (42S) is arranged within 1 / 4 or less of the width of the sagittal cross section of the base.

16. The ventilation assembly (37) according to claim 14, characterized in that, Each of the protrusions having a vertex (42S) is arranged within a range of 1 / 5 to 1 / 10 of the width of the sagittal cross section of the base.

17. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, It includes one or more connectors for operatively connecting the strap and the pusher.

18. The ventilation assembly (37) according to claim 17, characterized in that, The connector is used to at least partially reversibly connect the strap and the pusher.

19. The ventilation assembly (37) according to claim 17, characterized in that, The one or more connectors include at least one hook and / or at least one loop for operatively engaging the strap.

20. The ventilation assembly (37) according to claim 19, characterized in that, The at least one hook and / or ring includes a support portion extending along an axis for operably engaging the strap circumferentially surrounding the support portion, the support portion being provided with a plurality of axial corrugations forming circumferential circular teeth.

21. The ventilation assembly (37) according to claim 20, characterized in that, The multiple axial corrugations are stacking edges.

22. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The strap may be attached or has been attached to be arranged, at least in use, in the lateral proximity of the protrusion or the apex (42S) of each protrusion (42).

23. The ventilation assembly (37) according to claim 22, characterized in that, The strap may be attached or has been attached for connecting and securing the strap substantially symmetrically to the pusher with respect to the sagittal plane passing through the apex of the respective protrusion.

24. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The strap may be a flexible strap.

25. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, The band provides a widened portion of the skull.

26. The ventilation assembly (37) according to any one of claims 1-4, characterized in that, Includes one or more silencers and / or sound generators for controlling the sound entering the subject's ears.

27. A component comprising a ventilation assembly (37) and a laryngeal mask (5) according to any one of claims 1-26.

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