Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
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  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
  • A61M16/022—Control means therefor
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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  • A61M16/0605—Means for improving the adaptation of the mask to the patient
  • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
  • A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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• • A—HUMAN NECESSITIES
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  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
  • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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  • A61M2205/00—General characteristics of the apparatus
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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Definitions

• Another aspect of one form of the present technology comprises a patient interface for delivery of a supply of pressurised air at a continuously positive pressure with respect to ambient air pressure to an entrance of a patient’s airways , the patient interface being configured to maintain a therapy pressure in a range of about 4 cmfTO to about 30 cmHiO above ambient air pressure in use, throughout the patient’s respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing.
• the patient interface may comprise a connection port to fluidly connect, in use, with an air circuit connected to the supply of pressurised air, the connection port being located, in use, proximal a top, side or rear portion of a patient’s head.
• Another aspect of one form of the present technology comprises a positioning and stabilising structure to hold a seal-forming structure in a therapeutically effective position on a head of a patient, the seal-forming structure being constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH20 with respect to ambient air pressure throughout the patient’s respiratory cycle in use.
• the positioning and stabilising structure may comprise at least one hoop extending, in use, across the patient’s cheek regions and arranged to contact, in use, regions of the patient’s head superior to an otobasion superior of the patient’s head.
• the at least one hoop may comprise at least one gas delivery tube to deliver the flow of air to the entrance of a patient’ s airways via the seal-forming structure.
• the at least one gas delivery tube being constructed and arranged to overlie, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head.
• the positioning and stabilising structure may comprise a rear strap configured, in use, to pass around the back of the patient’s head.
• the positioning and stabilising structure may also comprise an adjustment mechanism for adjustment of the at least one hoop to enable the positioning and stabilising structure to fit different size heads.
• the adjustment mechanism may comprise one or more insert members configured to be selectably connected to the gas delivery tube to alter the length of the gas delivery tube. At least one of the inserts includes a coupling to connect the rear strap to the gas delivery tube.
• the at least one hoop may comprise at least one gas delivery tube to deliver the flow of air to the entrance of a patient’ s airways via the seal-forming structure.
• the at least one gas delivery tube being constructed and arranged to overlie, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head.
• the positioning and stabilising structure may comprise an adjustment mechanism for adjustment of the at least one hoop to enable the positioning and stabilising structure to fit different size heads.
• the adjustment mechanism may comprise one or more inflatable portions.
• Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured to leave the patient’s mouth uncovered in use.
• Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured so that no part of the seal forming structure enters the mouth in use.
• Fig. 14 shows a patient interface 3000 comprising a positioning and stabilising structure 3300 having band 3395 in accordance with one form of the present technology.
• FIGs. 23A and 23B shows a part of a patient interface comprising an inflatable portion 10420 in accordance with one form of the present technology.
• Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk.
• the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk.
• the flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected.
• the frusto-cone may be axially displaced towards the structure to which the stalk is connected.
• the positioning and stabilising structure 3300 may comprise at least one tie.
• a tie will be understood to be a structure designed to resist tension. In use, a tie is part of the positioning and stabilising structure 3300 that is under tension. Some ties will impart an elastic force as a result of this tension, as will be described. A tie may act to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient’s head.
• the positioning and stabilising structure 3300 may comprise ties in the form of headgear tubes 3350 and/or headgear straps, as will now be described.
• the patient interface 3000 may comprise a connection port 3600 located proximal a top, side or rear portion of a patient’s head.
• a connection port 3600 located proximal a top, side or rear portion of a patient’s head.
• Rigidizing or stiffening elements may be in positioning and stabilising structures 3300 which are configured to support relatively heavy seal forming structures such as full face or oro-nasal cushion assemblies.
• the patient interface 3000 is configured such that the connection port 3600 is positioned approximately at a top point of the patient’s head.
• the connection port 3600 may be positioned in the sagittal plane and aligned with the otobasion superior points in a plane parallel to the coronal plane.
• the otobasion superior points are identified in Fig. 2D.
• the headgear 3300 is configured to be worn in different positions, with the effect that the connection port 3600 may be positioned proximate the top of the patient’s head in the sagittal plane up to around 20mm forward or 20mm rearward of the otobasion superior points.
• the tubes 3350 may be crush resistant to avoid the flow of breathable gas through the tubes if either is crushed during use, for example if it is squashed between a patient’s face and pillow. Crush resistant tubes may not be necessary in all cases as the pressurised gas in the tubes may act as a splint to prevent or at least restrict crushing of the tubes 3350 during use. A crush resistant tube may be advantageous where only a single tube 3350 is present as if the single tube becomes blocked during use the flow of gas would be restricted and therapy will stop or reduce in efficacy.
• Certain forms of the present technology may comprise multiple headgear straps to increase stability as described above, for example a rear strap, side headgear straps, and a chin strap.
• the direction of the force applied to the headgear tubes 3350 by the rear strap 3310 may also be altered. This direction may be altered by adjusting the angle of the rear strap 3310 relative to the headgear tubes 3350 or patient’s head.
• the location at which the rear strap 3310 exerts a force on the headgear tubes 3350 may be altered by adjusting the location at which the rear strap 3310 is secured to the headgear tubes 3350.
• the strap 3310 may be configured in use to be in tension, and to direct a force to draw the seal-forming structure 3100 into sealing contact with a portion of a patient’s face.
• the strap may be configured as a tie.
• the positioning and stabilising structure 3300 comprises a strap 3310 that is adjustable in order to alter the length of the strap.
• the strap 3310 may connect to tubes 3350 by a strap adjustment mechanism, e.g. hook-and-loop fasteners.
• An adjustable strap 3310 may add further adjustment capability to other adjustment features of the patient interface 3000 to enable a patient to improve comfort and fit.
• the degree of adjustability provided by other parts of the positioning and stabilising structure may mean the patient interface 3000 is sufficiently adjustable without strap 3310 also being adjustable.
• the adjustment mechanism 3360 allows the patient interface 3000 to be adjusted to improve the fit of the patient interface 3000 to the patient’s head, and thereby to enable the patient interface 3000 to fit different size heads.
• a patient interface that fits a patient well is comfortable to wear, is likely to be more stable and thus reduces the likelihood of seal disruption and maintains the sealing structure against the entrance of the patient’s airways with a comfortable level of headgear tension. These factors improve patient compliance with therapy, improving therapeutic results.
• the adjustment mechanism may comprise a plurality of mechanisms for adjustment. For example, combinations of adjustment mechanisms described below may be provided to headgear in some forms of the present technology.
• adjustment mechanism 3360 Different forms of adjustment mechanisms 3360 will be described in the ensuing description. In some forms the adjustment mechanism 3360 is comprised as part of the headgear tubing 3350 while in other forms the adjustment mechanism 3360 is distinct from the headgear tubing 3350. Certain forms of the technology may comprise multiple adjustment mechanisms 3360 as described below.
• the adjustment mechanism 3360 comprises tubes 3350 having one or more folding portions, pleats, corrugations or bellows, i.e. the folding portions pleats, corrugations or bellows comprise the adjustment mechanism 3360.
• the length of the respective tube 3350 is different to its length when the folding portion is in a second, unfolded configuration.
• the patient interface 3000 shown in Fig. 3A comprises tubes 3350 comprising a concertina tube section 3362 between lengths of the tubes 3350 without concertinas.
• Concertina tube section 3362 comprises a plurality of folds or bellows able to fold and unfold independently or in concert to shorten or lengthen the concertina tube section 3362 and hence the respective tube 3350.
• the folds in concertina tube section 3362 may be able to be expanded (stretched) or contracted by differing degrees on different sides of the tube 3350.
• the concertina folds on the side of the tube 3350 nearest the patient’s head may be contracted more than those furthest from the patient’s head, which increases the curvature of the tubes 3350. This allows the shape of the tubes 3350 to be altered as well as their length, which also helps the patient interface be adjusted to fit the patient’s specific head size and head shape.
• the walls of the concertina tube section 3362 are less extended (e.g. more collapsed) on the anterior side than on the posterior side in the case of concertina tube section 3362a, i.e. when the headgear is worn on the patient’s head forwardly of the coronal plane.
• the tube 3350 positioned over the left side of the patient’s face is structured symmetrically to the tube 3350 over the right side of the patient’s face.
• the tubes 3350 may have different structures on each side of the patient’s face.
• the second tab 3373 may slide towards a peripheral edge of the first tube 3370 such that when the second tab 3373 contacts the peripheral edge it acts as a stop to prevent further shortening of the tube 3350.
• a patient interface in which a tube portion formed from a relatively flexible material telescopically moves relative to a tube portion formed from a relatively rigid material is that, when the inner tube portion is pushed towards the outer tube portion, the tube portion made of the relatively flexible material may buckle. This may affect the ease with which the length of tubes 3350 can be adjusted.
• the patient interface 3000 shown in Fig. 7B comprises rigidizing members 3379 to address this problem.
• Rigidizing members 3379 act to increase the rigidity of the section of second tube portion 3372 that moves, in use, in and out of first tube portion 3370.
• rigidizing members 3379 are lengths of relatively rigid material provided to the upper side of each of second tube portions 3372.
• the patient interface of Fig. 7B comprises a padded member 3330 on a patient contacting side of the upper tube member 3351 to improve comfort when the patient interface 3000 is worn.
• One or more padded members 3330 may be provided to any part of the positioning and stabilising structure 3300 of any of the forms of patient interface 3000 described in this specification unless otherwise stated.
• padded members 3330 may be provided to a part of the tubes 3350 to make wearing the patient interface more comfortable.
• Padded members 3330 may be permanently attached to a part of tubes 3350, for example by being moulded (e.g. co moulded or overmoulded) or adhered thereto.
• a loop of the patient interface 3000 that encircles a part of the patient’s head when the patient interface 3000 is worn is defined by the strap 3390, the cushion assembly 3150 and the parts of tubes 3350 connected between strap 3390 and cushion assembly 3150.
• the size of this loop may be adjusted by adjusting the strap.
• the patient interface comprises a strap adjustment mechanism 3391 by which the length of the strap 3390 may be adjusted.
• Strap adjustment mechanism 3391 may comprise an adjustable fastening attachment between two sections of the strap 3390. For example, one section of the strap 3390 may pass through a loop attached to the end of the other section of the strap 3390 and attach to itself using a hook-and-loop material.
• link member 7394 may comprise the first and second hoop and strap sections connected together using poppers or interlocking members that can connect in a plurality of different positions.
• upper sections of the two tubes 3350 are secured together by a clasp locker or zip.
• a clasp locker or zip For example, one row of teeth of the clasp locker may be mounted on one tube 3350 and another row of teeth of the clasp locker may be mounted on the other tube 3350.
• the slider is moveable between the rows of teeth to adjust the position at which the two tubes 3350 are held together to alter the size of the loop formed by the patient interface 3000 are thereby accommodate different patient head sizes.
• the swivel joint 8408, 9408 of both the de-coupling structure 8600 and the de-coupling structure 9600 include two degrees of rotational freedom.
• a difference between the two de-coupling structures 8600, 9600 relates to which axis is adjacent to the upper ends 9411. This, in turn, may determine a direction that the pressurized air flows into the de-coupling structure 8600, 9600.
• the axis of rotation 8414 is the perpendicular axis, so a conduit conveying the pressurized air to the de-coupling structure 8600 may extend substantially horizontally from the de coupling structure 8600.
• the opposite may be true in the de-coupling structure 9600, where the conduit may extend substantially vertically.
• a patient may desire one de coupling structure 8600, 9600 over the other based on preferred sleeping positions.
• the adjustment mechanism 7391 may comprise a link member 7394 between a first 7392 and second 7393 section of the front hoop 7390 and rear strap 7310.
• the link member 7394 may operate by adjusting of the length of the link between the first 7392 and second 7393 hoop and strap sections.
• each different length of insert member 9410 is marked with a size indication, for example, ‘S’ for small (e.g., 9410a), ‘M’ for medium (e.g., 9410b), and ‘L’ for large (e.g., 9410c).
• the second fastening member 9358 on one end of the insert member 9410 may be connected to the first fastening member 9357 on one end of the stretchable section 9355.
• the insert member 9410 may be longer than the distance between the first fastening member 9357 on the other end of the stretchable section 9355.
• the patient may have to stretch the stretchable section 9355 in order to align and connect the first and second fastening members 9357, 9358.
• the stretchable section 9355 has increased in length (i.e., the stretchable section’s length is greater than in a relaxed position).
• the total increase in length may be dependent on the specific insert member 9410 that the patient selected (e.g., small, medium, or large).
• the selected insert member 9410 may be positioned substantially symmetrically about the patient’s sagittal plane.
• the senor may be a light sensor and/or a position sensor, and may detect the proximity between the patient’ s head and the inflatable portion 10420 in order to determine how much the air should enter the inflatable portion 10420.
• the patient interface 3000a (the forward position) can fit over a larger head (shown in phantom) since it is worn forward.
• the patient interface 3000c (rearward position) can fit properly to a smaller head (shown in phantom) with the same length of adjustment mechanism 3360.
• connection port 3600a is positioned generally forward of the adjustment mechanism 3360a. In this position, the connection port 3600a is anterior to the otobasion superior points.
• Fig. 3 J identified by reference numerals labelled “c”
• the patient is wearing the headgear tubing 3350c in a relatively rearward position compared to the position of headgear tubing 3350b (e.g. posterior to and inclined relative to the coronal plane). In this configuration, the connection port 3600c is positioned generally rearward of adjustment mechanism 3360c. In this position, the connection port 3600c is posterior to the otobasion superior points.
• Fig. 3K shows a patient interface 3000 with positioning and stabilising structure 3300 having headgear tubes 3350 and a headgear tube adjustment mechanism in a first configuration identified with the reference numeral 3360.
• the adjustment mechanism 3360 is also shown in phantom in a second configuration and identified with the reference numeral 3360’.
• the headgear 3300 fits around a patient with one size head and in the second configuration of the adjustment mechanism 3360’ the headgear 3300 fits around a patient with a larger head.
• the adjustment mechanism 3360’ enables an extension of the length of the headgear tubes 3350 in order to fit around the larger head.
• Fig. 3K shows a patient interface 3000 with positioning and stabilising structure 3300 having headgear tubes 3350 and a headgear tube adjustment mechanism in a first configuration identified with the reference numeral 3360.
• the adjustment mechanism 3360 is also shown in phantom in a second configuration and identified with the reference numeral 3360’.
• the adjustment mechanism 3360’ enables an extension
• a non-adjustable headgear tube section is a section that is not specifically configured to be dimensionally adjusted during use, i.e. the adjustment mechanism does not form part of the non-adjustable headgear tube section. This does not preclude, however, the non-adjustable headgear tube section being able to be dimensionally adjusted if, for example, excessive force is imparted on it. The position of the non-adjustable headgear tube section may, however, be adjusted during use.
• non-adjustable headgear tube sections may be substantially non-adjustable in axial length, but may be adjustable in other ways such as by flexing, curving, straightening, and the like. For example, as shown in Fig. 3L, the non-adjustable headgear tube sections 3363a,
• the concertina sections 3362 are positioned on either side of the patient’ s head between the ears or ear level and the crown or top of the head and non- adjustable headgear tube sections 3363, which form the lower ends of the headgear tubes (i.e. the inferior ends when worn by a patient) are positioned adjacent to (or over) the patient’s cheek region when worn.
• non- adjustable headgear tube sections 3363 are shown in Figs. 5, 7A, 7B, 7C and 17.
• the adjustment mechanism may be positioned close to the cushion assembly 3150 of the patient interface and be spaced from the patient’ s face by virtue of the size of the plenum chamber and the location of the port to which the tube 3350 connects to the plenum chamber distancing the lower end of the tube 3350 (and consequently the adjustment mechanism) from the patient’s skin.
• the form of the present technology shown in Fig. 10B is one such example of a patient interface 3000 where the adjustment mechanism is spaced from the patient’s face in use.
• a bias mechanism may also assist in automatically adjusting the patient interface to fit a particular patient’s head.
• the bias mechanism is preferably configured to apply sufficient inwards (i.e. towards the patient’s airway openings) force to maintain a good seal during use while avoiding applying an excessive force.
• An excessive force may cause the seal forming structure 3100 to compress and its geometry change so that some parts of the structure move away from the patient’ s face and gas leaks out of the seal-forming structure.
• avoiding excessive forces on the patient’s face from the patient interface promote comfort and avoid red marks, abrasion or sweating on the patient’s face.
• the relatively stretchable section of tube 3355 is resiliently or elastically deformable and has a tendency to return to its non-stretched state. Therefore in use the relatively stretchable section of tube 3355 acts to pull the seal-forming structure 3100 into the patient’s face.
• tubes 3350 may be completely formed from a resilient material that tends to return to its non-stretched state when stretched.
• patient interface 3000 comprises one or more elastic sleeves 3340 that cover the tubes 3350. It will be understood that the elastic sleeves 3340 may partly cover the tubes 3350, for example there may be holes in the sleeves 3340 such as will be described below.
• One form of vent in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.
• the vent may be located in the plenum chamber 3200.
• the vent may be located in another part of the patient interface, e.g., a tube 3350 fluidly connecting connection port 3600 with the plenum chamber 3200.
• Connection port 3600 allows for connection to the air circuit 4170.
• the connection port is positioned on top of the patient’s head when the patient interface 3000 is being worn.
• the connection port is configured to be positioned, in use, proximal a top, side or rear portion of the patient’s head.
• Patient interfaces in which the connection port is not positioned in front of the patient’s face may be advantageous as some patient’s find a conduit that connects to a patient interface in front of the face to be unsightly and obtrusive.
• a conduit connecting to a patient interface front of the face may be prone to being tangled up in bedclothes, particularly, if the conduit extends downwardly from the patient interface in use.
• a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplemental oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.
• An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical and pneumatic components 4100, electrical components 4200 and is configured to execute one or more algorithms 4300.
• the RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015.
• the RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000.
• the RPT device 4000 may include a handle 4018.
• the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.
• PCBA Printed Circuit Board Assembly
• An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.
• an outlet air filter 4114 for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000.
• the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air.
• the heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors.
• the heated wire circuit may be helically wound around the axis of the air circuit 4170.
• the heating element may be in communication with a controller such as a central controller 4230.
• a controller such as a central controller 4230.
• One example of an air circuit 4170 comprising a heated wire circuit is described in United States Patent 8,733,349, which is incorporated herewithin in its entirety by reference. 8.5 HUMIDIFIER
• APAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.
• a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient.
• Total flow rate, Qt is the flow rate of air leaving the RPT device.
• Vent flow rate, Qv is the flow rate of air leaving a vent to allow washout of exhaled gases.
• Leak flow rate, Ql is the flow rate of leak from a patient interface system or elsewhere.
• Respiratory flow rate, Qr is the flow rate of air that is received into the patient's respiratory system.
• leak The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.
• Respiratory Pressure Therapy The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.
• Ventilator A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
• ‘Rigid’ structure or component A structure or component that will not substantially change shape when subject to the loads typically encountered in use.
• An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmFFO pressure.
• Effort ( breathing ) The work done by a spontaneously breathing person attempting to breathe.
• Expiratory portion of a breathing cycle The period from the start of expiratory flow to the start of inspiratory flow.
• Typical recent ventilation The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the recent values of ventilation.
• Upper airway obstruction includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).
• Expiratory positive airway pressure a base pressure, to which a pressure varying within the breath is added to produce the desired mask pressure which the ventilator will attempt to achieve at a given time.
• Alare The most lateral point on the nasal ala.
• Alar curvature (or alar crest ) point The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.
• Columella the strip of skin that separates the nares and which runs from the pronasale to the upper lip.
• Lateral nasal cartilage A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.
• Lip, lower (lab rale inferius): A point on the face between the mouth and supramenton, lying in the median sagittal plane.
• Otobasion inferior The lowest point of attachment of the auricle to the skin of the face.
• Philtrum the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.
• Frontal bone The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
• Maxilla The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.
• a shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness.
• a curved structural wall of a mask may be a shell.
• a shell may be faceted.
• a shell may be airtight.
• a shell may not be airtight.
• Strut A stmt will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.
• Vent (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases.
• a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.
• PCBA Printed Circuit Board Assembly

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• 2020
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