Crushable conduits, patient interfaces, and headgear connectors

Abstract

A conduit is described that includes a collapsible portion and a nasal interface for providing a flow of gas to a user. The patient interface includes a manifold and at least one nasal prong or outlet extending from the manifold for reception in a user's nostril. Side members extend from each side of the manifold, each side member including a collapsible portion that includes a lumen. In the open configuration, the lumen remains open, and in the closed configuration, the collapsible portion is pinched or flattened to occlude or substantially occlude the lumen. At least one of the side members is a conduit for gas flow from the patient interface inlet to the manifold.

Description

Technical Field

[0001] The present disclosure relates to various patient interfaces, and particularly to patient interfaces for use with high-flow systems, i.e., high-flow systems. The patient interface includes features that can be intentionally collapsed to facilitate stopping the gas flow through the patient interface and / or to enable the use of a face mask that covers the upper side of the patient interface while it is positioned on the user's face. The present disclosure also relates to a headgear connector and a breathing tube having a collapsible portion.

Background Art

[0002] A patient can lose respiratory function during anesthesia, or while being sedated, or more generally, during some medical procedures. Prior to a medical procedure, the patient can be pre-oxygenated by a medical professional to receive a store of oxygen saturation, and this pre-oxygenation and flushing / washing out of CO2 is performed using high-flow therapy via a nasal cannula or other patient interface.

[0003] Once under general anesthesia, the patient needs to be intubated and ventilated. In some cases, intubation is completed in 30 - 60 seconds, but in other cases, especially when it is difficult to cross the patient's airway (e.g., due to cancer, severe injury, obesity or neck muscle spasm), intubation takes a significantly long time. Pre-oxygenation alleviates the decrease in oxygen saturation, but if the intubation procedure takes a long time, it is necessary to interrupt the intubation process and raise the patient's oxygen saturation to an appropriate level. Interruptions in the intubation process can occur several times in a difficult intubation process, which takes time and exposes the patient to significant health risks. After about three attempts at intubation, a medical procedure, such as intubation, is aborted.

[0004] When an apnea-prone, unintubated patient needs to be manually ventilated urgently (for example, due to a failed intubation attempt), the high-flow patient interface must be quickly removed before applying a non-invasive ventilation mask, such as a face mask and bag. Cannulas can be difficult to remove quickly from the patient; for example, the connector between the headgear and the cannula can be difficult to detach quickly or operate with one hand. Failure to remove the patient interface can cause the cushion of the face mask covering the patient interface or the patient interface gas supply tube to break the seal between the face mask and the patient's face. Thus, gas may leak from the face mask during ventilation, rendering ventilation ineffective or unsustainable.

[0005] Where this specification refers to external sources, including patent specifications and other documents, these references are, in general, for the purpose of providing context for describing the features of the invention. Unless otherwise specified, references to such sources should not be considered in any jurisdiction as an endorsement that such sources are prior art or form part of the general knowledge well known in the art. [Overview of the project] [Problems that the invention aims to solve]

[0006] The purpose of this disclosure is to provide a respiratory conduit or patient interface or headgear connector that can help, to some extent, overcome one or more of the problems or difficulties described above, or to provide a useful alternative for industry / the general public. [Means for solving the problem]

[0007] According to at least one of the embodiments disclosed herein, a breathing conduit for providing a flow of breathing gases, whether formed together with or as a separate conduit to a patient interface, includes a collapsible portion, the lateral cross section of which is: A first side portion including a flat portion for positioning in contact with the user's face, A second side facing the first side and facing outward from the user's perspective. Includes, The first and second sides are joined by the first and second bending points, and in the open configuration, the bending points are spaced apart from the flat portion of the first side in a direction away from the user's face during use. The inner length of the first side between the inflection points and the inner length of the second side between the inflection points are substantially equal, and In a partial or closed configuration, the second side is moved toward or toward the first side, with the portion that can be crushed overlapping at the first and second bending points.

[0008] In some embodiments, the first side, when in an open configuration, includes an outwardly curved portion between the flat portion and each of the first and second bending points.

[0009] In some embodiments, the thickness of the outwardly curved portion is tapered from a thicker thickness towards each bending point, starting from the flat portion.

[0010] In some embodiments, the first side is curved outward when in an open configuration.

[0011] In some embodiments, the second side is curved outward when in an open configuration.

[0012] In some embodiments, in a closed configuration, the bending point is moved to touch or be adjacent to the user's face.

[0013] In some embodiments, the thickness of the first and / or second side is tapered from a thicker thickness to a thinner thickness towards each bending point.

[0014] In some embodiments, the maximum thickness of the first side is at the apex of the first side, and / or the maximum thickness of the second side is at the apex of the second side.

[0015] In some embodiments, the thickness at the bending point is thinner than the thickness of the rest of the cross-section of the portion that can be crushed.

[0016] In some embodiments, the second side is thinner than the first side.

[0017] In some embodiments, in the open configuration, the first side adjacent to each inflection point is at an angle to the flat portion, so that the exterior angle between the first side adjacent to the inflection point and the flat portion is less than 80 degrees, or less than 75 degrees, or less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or 50 to 70 degrees, or 60 to 70 degrees, or about 62 to 68 degrees, or about 64 to 66 degrees, or about 65 degrees.

[0018] In some embodiments, in an open configuration, a line tangential to a first side portion adjacent to each inflection point is at an angle to a line extending between the first and second inflection points, so that the angle (β) between that line and the portion adjacent to the inflection point can be less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or 30 to 60 degrees, or 40 to 50 degrees, or about 45 degrees.

[0019] In some embodiments, the thickness of the flat portion is approximately 0.5 mm, and the thickness of the inflection point is approximately 0.2 mm.

[0020] In some embodiments, the length of the flat portion is about 5 mm to 10 mm or about 7 mm, and / or the lateral width of the cross-section of the collapsible portion is 10 mm to 15 mm or about 13 mm.

[0021] In some embodiments, the first side portion is tapered from a thickness of 0.5 mm to a thinner thickness at the bending point.

[0022] In some embodiments, i) the ratio of the (thicker) center thickness of the first and / or second side portion of the cross-section to the (thinner) thickness at the bending point is in the range of about 1 to 8, or about 1.5 to 3.5, or ii) the ratio of the thickest portion of the cross-section to the thinnest portion of the cross-section at the bending point is in the range of about 1 to 8, or about 1.5 to 3.5.

[0023] In some embodiments, the ratio of the relative thickness of the (thicker) flat portion of the first side portion to the (thinner) bending point is in the range of about 1 to 8, or about 1.5 to 3.5.

[0024] In some embodiments, the first and second bending points define or delimit the range of the first and second side portions, or the first and second side portions each extend completely between the bending points, for example from the first bending point to the second bending point.

[0025] In some embodiments, the collapsible section has mirror symmetry about the centerline of the cross-section, and the centerline extends through the centers of the first and second side portions of the cross-section.

[0026] In some embodiments, the distance between the bending points exceeds the width of the flat portion.

[0027] In some embodiments, the maximum width of the cross-section is defined by the distance between the bending points.

[0028] In some embodiments, the first and second sides are curved outward, and the cross-section is substantially oval or elliptical, but the first and second sides converge to a certain point at each bending point.

[0029] In some embodiments, the first side extends outward toward the respective bending points on both sides of the flat portion.

[0030] In some embodiments, the conduit is the conduit portion of the patient interface.

[0031] In some embodiments, the patient interface is a nasal interface.

[0032] In some embodiments, the nasal interface is a nasal cannula.

[0033] In some embodiments, the collapsible portion is formed from an elastomer / elastic material, such as silicone.

[0034] According to at least one of the embodiments disclosed herein, a respiratory conduit for providing a flow of respiratory gas, whether formed together with or as a separate conduit to a patient interface, includes a collapsible portion, the cross-section of which is: A first side portion for positioning in contact with the user's face, Opposite the first side, a second side facing outward from the user's face, Includes, The first and second sides are joined by the first and second bending points. The conduit is adapted to collapse from an open configuration to a closed configuration by folding at the bends, so that when in the closed configuration, the first and second sides are positioned to be in contact with or adjacent to each other, substantially blocking the flow through the conduit.

[0035] In some embodiments, the inner length of the first side between the inflection points and the inner length of the second side between the inflection points are substantially equal.

[0036] In some embodiments, the cross-section has mirror symmetry about lines extending through the first and second inflection points.

[0037] In some embodiments, the cross-section has mirror symmetry about the centerline of the cross-section, and the centerline extends through the centers of the first and second sides of the cross-section.

[0038] In some embodiments, the second side is curved outward when in an open configuration.

[0039] In some embodiments, the first side is curved outward when in an open configuration.

[0040] In some embodiments, in a closed configuration, the bending point is moved to touch or be adjacent to the user's face.

[0041] In some embodiments, the thickness of the first and / or second side is tapered from thicker to thinner towards each bending point, with the maximum thickness at the respective apex of the first and second side.

[0042] In some embodiments, the thickness at the bending point is thinner than the thickness of the rest of the cross-section of the portion that can be crushed.

[0043] In some embodiments, the second side is thinner than the first side.

[0044] In some embodiments, i) The ratio of the thickness of the (thicker) center to the thickness of the (thinner) inflection point of the first and / or second side of the cross section is in the range of approximately 1 to 8, or approximately 1.5 to 3.5, or ii) The ratio of the thickest part of the cross section to the thinnest part of the cross section, which is the inflection point, is in the range of approximately 1 to 8, or approximately 1.5 to 3.5.

[0045] In some embodiments, in an open configuration, a line tangential to a first side portion adjacent to each inflection point is at an angle to a line extending between the first and second inflection points, and the angle (β) between that line and the portion adjacent to the inflection point may be less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or about 30 to 60 degrees, or about 40 to 50 degrees, or about 45 degrees.

[0046] In some embodiments, the first and second inflection points define or define the extent of the first and second sides, or the first and second sides each extend completely between the inflection points, for example, from the first inflection point to the second inflection point.

[0047] In some embodiments, the maximum width of the cross-section is defined by the distance between the inflection points.

[0048] In some embodiments, the first and second sides are curved outward, and the cross-section is substantially oval or elliptical, but the first and second sides converge to a certain point at each bending point.

[0049] In some embodiments, the conduit is the conduit portion of the patient interface.

[0050] In some embodiments, the patient interface is a nasal interface.

[0051] In some embodiments, the nasal interface is a nasal cannula.

[0052] In some embodiments, the collapsible portion is formed from an elastomer / elastic material, such as silicone.

[0053] According to at least one of the embodiments disclosed herein, a breathing conduit for providing a flow of breathing gas, whether formed together with or as a separate conduit to a patient interface, includes a collapsible portion, the cross-section of which is substantially rhombic or parallelogram-shaped, the four corners or angles of the rhombic or parallelogram-shaped cross-section providing points of inflection, in an open configuration, the four sides of the rhombic or parallelogram are spaced apart, and in a closed configuration, the cross-sections fold at the corners so that adjacent sides of the rhombic or parallelogram are in contact, and the corners include acute interior angles at the edges of the cross-sections.

[0054] In some embodiments, the cross-section of the collapsible portion is substantially parallelogram-shaped, and the longer sides of the parallelogram are positioned to touch the user's face during use.

[0055] In some embodiments, the acute angles of the rhombus or parallelogram may be less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or between 45 and 65 degrees, or between 55 and 65 degrees, or about 60 degrees.

[0056] In some embodiments, the thickness of the sides of the rhombus or parallelogram is tapered from thicker to thinner towards each corner (bend point) with an acute angle.

[0057] In some embodiments, the thickness of the corner (bending point) having an acute angle is thinner than the thickness of the side or the rest of the cross-section of the portion that can be crushed.

[0058] In some embodiments, the sides of the rhombic or parallelogram-shaped cross-section that are positioned to touch the user's face are thicker than the other sides of the rhombic or parallelogram-shaped cross-section.

[0059] In some embodiments, i) The ratio of the relative thickness between the (thicker) side of the cross section and the (thinner) inflection point is in the range of approximately 1 to 8, or approximately 1.5 to 3.5, or ii) The ratio of the thickest part of the cross section to the thinnest part of the cross section, which is the inflection point, is in the range of approximately 1 to 8, or approximately 1.5 to 3.5.

[0060] In some embodiments, the cross-section includes internal notches at the acute-angled corners, so the thickness at the acute-angled corners is thinner than the thickness at the sides of the cross-section.

[0061] In some embodiments, the thickness of the sides of the rhombus or parallelogram is about 0.5 mm, and the thickness of the corners with acute angles is about 0.2 mm.

[0062] In some embodiments, the cross-section of the collapsible portion includes a tail portion extending from one or both corners of the section having an acute interior angle, each tail portion providing a slope from the edge of the section to the top of the section in a closed configuration.

[0063] In some embodiments, the sides of the rhombic or parallelogram-shaped cross-section, which are positioned to be in contact with the user's face, are thicker than the other sides of the rhombic or parallelogram-shaped cross-section, and The cross-section includes only one tail portion extending from the corner of the cross-section, which contains an acute angle on the thicker side of the cross-section.

[0064] In some embodiments, the thickness of the side of the cross-section is tapered such that it is thicker at at least one corner of the cross-section having an obtuse angle.

[0065] In some embodiments, the thickness of the cross-section is tapered from the edge of the cross-section to a thicker section between the edges of the crushed cross-section, providing a tapered crushed cross-section.

[0066] In some embodiments, the cross-section has mirror symmetry with respect to a line extending through a corner having an obtuse angle.

[0067] In some embodiments, the conduit is the conduit portion of the patient interface.

[0068] In some embodiments, the patient interface is a nasal interface.

[0069] In some embodiments, the nasal interface is a nasal cannula.

[0070] In some embodiments, the collapsible portion is formed from an elastomer / elastic material, such as silicone.

[0071] According to at least one of the embodiments disclosed herein, the patient interface includes a respiratory conduit as described in one or more of the above descriptions.

[0072] In some embodiments, the interface is a nasal interface that includes a single inlet, at least one nasal outlet, and a respiratory conduit extending between the single inlet and the at least one nasal outlet.

[0073] According to at least one of the embodiments disclosed herein, a connector adapted to connect a headgear to a patient interface is: A first connector component (e.g., a male component) and a second connector component (e.g., a female component), wherein the second connector component includes a pair of spaced tines that receive the first component when the first and second components are connected. Includes.

[0074] In some embodiments, each tine extends from the base of the second component, and the distal end of each tine is free to flex laterally relative to the base.

[0075] In some embodiments, one or both of the tines include an aperture or lateral projection, and the first component includes a corresponding lateral projection or aperture, such that the lateral projection is received by the aperture when the first component is received between the tines, thereby holding the first and second components together.

[0076] In some embodiments, the aperture is a slot whose principal axis is oriented laterally to the longitudinal axis of a headgear strap that is attached to the patient interface.

[0077] In some embodiments, each tine includes the aperture, and the first connector includes the lateral projection on each side of the first component.

[0078] In some embodiments, the first and second parts are fitted complementaryly to rotate relative to each other from an engaged position to a disengaged position, and the first and second parts include complementary features such that the relative rotation between the first and second parts flexes and spreads the tines, releasing the second part from the first part.

[0079] In some embodiments, the aperture and projection are fitted complementaryly so that relative rotation between the first and second parts releases the projection from the aperture and flexes the tine over the projection.

[0080] In some embodiments, the lateral projection includes a chamfered edge that flexes the tines when the first component is inserted axially between the tines of the second component.

[0081] In some embodiments, the second connector component is releasably coupled to the headgear.

[0082] According to at least one of the embodiments disclosed herein, a connector adapted to connect a headgear to a patient interface is: A complementary second connector component (e.g., a female component) comprising a first connector component (e.g., a male component) and a pair of spaced-apart elastic tines for receiving the first connector component, wherein the second connector component is fitted to be removably coupled to a headgear, the second connector component includes a base, each tine extends from the base, and the distal end of each tine is free to flex laterally relative to the base, so that the tines flex laterally to release the first connector component from the second connector component. Includes.

[0083] In some embodiments, the first and second connector components are adapted to be connected together by moving the second connector component axially toward the first connector component, and The connector components are adapted to disconnect by relative rotation around a lateral projection on the other of the first and second components, which is received into the aperture of one of the first and second components.

[0084] According to at least one of the embodiments disclosed herein, the patient interface is: A manifold, and at least one nasal prong or outlet extending from the manifold so as to be accepted into the user's nostril or mouth, Side members extending from each side of the manifold, each side member including a collapsible portion containing a lumen, in an open configuration the lumen remains open, and the collapsible portion is adapted to be sandwiched or flattened (e.g. by external force) into a closed configuration to close or substantially close the lumen, and at least one of the side members is a conduit for the flow of gas from the inlet of the patient interface to the manifold, side member Includes.

[0085] In some embodiments, the patient interface includes a plug and a conduit connector, the plug being fitted to the end of one or both side members, and the conduit connector being fitted to the other end of one or both side members.

[0086] In some embodiments, each side member is formed as a conduit, and the patient interface includes a plug and a conduit connector, both of which are fitted to the inlet ends of the side members, so that the patient interface can be configured as a dual-inlet patient interface or a single left- or right-side patient interface.

[0087] In some embodiments, the patient interface includes a wall near the inlet side of the nasal prongs or outlet, separating the lumen of one side member from the manifold and the other side member, so that only one side member functions as a conduit providing gas flow from the inlet of the patient interface to the manifold.

[0088] In some embodiments, the lumens of the side members, which are separate from the manifold, include escape holes, so the lumens of the side arms, which are separate from the manifold, are in communication with the atmosphere.

[0089] In some embodiments, the walls are curved or shaped in such a way as to direct the flow from the manifold to at least one nose prong or outlet and / or reduce resistance to the flow.

[0090] In some embodiments, the side members, manifold, and at least one nose prong or outlet are integrally formed as unitary members.

[0091] In some embodiments, the side members are formed from a relatively soft or compliant material, and the plug and / or conduit connectors are formed from a relatively hard or rigid material.

[0092] In some embodiments, the patient interface includes a removable shield that configures the patient interface for use without crushing.

[0093] In some embodiments, the shield is fitted to fit and cover the side member, or both side members and the manifold.

[0094] In some embodiments, the shield includes one or more pairs of jaws, each pair of which is configured to grip around a portion of the patient interface and hold the shield to the patient interface.

[0095] In some embodiments, the patient interface is a nasal cannula comprising a manifold and at least one of the nasal prongs or nasal outlets extending from the manifold so as to be received by the user's nostril.

[0096] In some embodiments, a portion of the headgear connector is formed integrally with each side member.

[0097] In some embodiments, when dependent on claim 13, a portion of the headgear connector is formed integrally with the conduit connector, and / or a portion of the headgear connector is formed integrally with the plug.

[0098] In some embodiments, the cannula includes a pair of headgear connector components (e.g., a pair of male components or a pair of female components), each component being adapted to connect to a corresponding headgear connector component to attach a headgear to the cannula, and each headgear connector component is positioned at a certain angle to the side member in a side view of the cannula, so that during use the cannula is positioned horizontally to the user's face and the headgear extends above the user's ears.

[0099] In some embodiments, the angle is 10 to 30 degrees, or 15 to 25 degrees, or about 20 degrees.

[0100] In some embodiments, in a plan view, the cannula includes an obtuse angle between its side members when it is in a neutral or uncurved configuration.

[0101] In some embodiments, the obtuse angle is in the range of 100 to 130 degrees, or about 100 to 120 degrees, or about 100 to 110 degrees, or about 105 degrees (e.g., 106 degrees).

[0102] In some embodiments, the side members are substantially straight in neutral or uncurved configurations, and the manifold is curved to provide an obtuse angle between the side members.

[0103] In some embodiments, the cannula includes a pair of headgear connector components (e.g., a pair of male components or a pair of female components), each component being connected to a corresponding headgear connector component to be fitted to the cannula to attach a headgear, and each headgear connector component is positioned at a certain angle with respect to a side member in a plan view of the cannula, the angle being in the range of 130 to 170 degrees, or 140 to 160 degrees, or 145 to 155 degrees.

[0104] In some embodiments, the cannula includes a pair of headgear connector components (e.g., a pair of male components or a pair of female components), each component being connected to a corresponding headgear connector component to be fitted to attach a headgear to the cannula, and the distance between the distal ends of the side arms or between the pair of headgear connector components is approximately 100mm to 150mm, or approximately 110mm to 140mm, or approximately 110mm to 130mm, or approximately 120mm.

[0105] According to at least one of the embodiments disclosed herein, the nasal cannula is: A manifold, and at least one nasal prong or outlet extending from the manifold to be accepted by the user's nostrils, and side members extending from each side of the manifold. including, and In a plan view, when the cannula is in a neutral or uncurved configuration, it includes an obtuse angle between the side members.

[0106] In some embodiments, the obtuse angle is in the range of 100 to 130 degrees, or about 100 to 120 degrees, or about 100 to 110 degrees, or about 105 degrees (e.g., 106 degrees).

[0107] In some embodiments, the side members are substantially straight in neutral or uncurved configurations, and the manifold is curved to provide an obtuse angle between the side members.

[0108] In some embodiments, the cannula includes a pair of headgear connector components (e.g., a pair of male components or a pair of female components), each component being connected to a corresponding headgear connector component to be fitted to the cannula to attach a headgear, and each headgear connector component is positioned at a certain angle with respect to a side member in a plan view of the cannula, the angle being in the range of 130 to 170 degrees, or 140 to 160 degrees, or 145 to 155 degrees.

[0109] In some embodiments, the cannula includes a pair of headgear connector components (e.g., a pair of male components or a pair of female components), each component being adapted to connect to a corresponding headgear connector component to attach a headgear to the cannula, and each headgear connector component is positioned at a certain angle to the side member in a side view of the cannula, so that during use the cannula is positioned horizontally to the user's face and the headgear extends above the user's ears.

[0110] In some embodiments, the angle is 10 to 30 degrees, or 15 to 25 degrees, or about 20 degrees.

[0111] In some embodiments, the nasal cannula includes a wall near the inlet side of the nasal prongs or outlet, separating the lumen of one side member from the manifold and the other side member, so that only one side member functions as a conduit providing gas flow from the cannula inlet to the manifold.

[0112] In some embodiments, the lumens of the side members, which are separate from the manifold, include escape holes, so the lumens of the side arms, which are separate from the manifold, are in communication with the atmosphere.

[0113] According to at least one of the embodiments disclosed herein, the conduit for a respiratory support system is: A portion that can be crushed, in an open configuration, the crushable portion remains open, and in a closed configuration, the crushable portion is crushed or flattened to block or substantially block a conduit, and A relatively rigid component adapted to move from a first configuration in which a collapsible portion is in an open configuration to a second configuration in which the component presses against the outside of the collapsible portion, thereby clamping or flattening the collapsible portion into a closed configuration. Includes.

[0114] In some embodiments, the components include a shield mounted on the outside of the crushable portion, the shield being adapted to distribute external forces applied to the shield to a predetermined crushable area of ​​the crushable portion.

[0115] In some embodiments, the components include a lever adapted to pivot from a first configuration to a second configuration.

[0116] In some embodiments, the conduit includes a portion that can be crushed and a portion that cannot be crushed, and the lever is swivel-mounted to the portion of the conduit that cannot be crushed.

[0117] In some embodiments, the conduit includes a ventilation aperture upstream of the portion that can be crushed, and the lever includes a first arm extending from a first side of the pivot and a second arm extending from an opposing second side of the pivot, In the first configuration, the lever pivots around the pivot so that the first arm does not pinch or flatten the portion that can be crushed, and the second arm substantially closes the ventilation aperture; and in the second configuration, the lever pivots around the pivot so that the first arm pinches or flattens the portion that can be crushed, and the second arm lifts from the ventilation aperture so that gas in the conduit upstream of the portion that can be crushed can be vented to the atmosphere.

[0118] In some embodiments, the ventilation aperture is located in a portion of the conduit that cannot be crushed.

[0119] In some embodiments, the lever includes a projection or rim that presses against a portion that can be crushed in a second configuration.

[0120] According to at least one of the embodiments disclosed herein, the patient interface is: Interface portion for interface with the user's nose or mouth airway, and A conduit as described in one or more of the above, which extends from the interface portion, and A relatively rigid component attached to a conduit or interface section for moving from the first configuration to the second configuration. Includes.

[0121] In some embodiments, the components include a lever that is swivel-mounted to the conduit or interface portion and swivels from a first configuration to a second configuration.

[0122] In some embodiments, the conduit includes a portion that can be crushed and a portion that cannot be crushed, and a lever is swivel-mounted to the non-crushable portion of the conduit, and the crushable portion is located between the interface portion and the non-crushable portion of the conduit.

[0123] In some embodiments, the patient interface is a nasal cannula, and the interface portion includes a manifold and at least one nasal prong or outlet extending from the manifold.

[0124] In some embodiments, the patient interface is an oral interface that is accepted in the user's mouth.

[0125] According to at least one of the embodiments disclosed herein, the patient interface is: The main body: A manifold, and at least one nasal prong or outlet extending from the manifold, A left side member extending from the left side of the manifold, and a right side member extending from the right side of the manifold, wherein each side member includes an inlet portion and a lumen providing a conduit for the flow of gas from the inlet portion to the manifold. The main unit, A frame including a tube connector and a hollow projection of a blank, wherein the tube connector and the hollow projection of the blank are adapted to receive the inlet portion of the body when the frame is attached to the body, and the frame is movably attached to the body to selectively configure the patient interface between a left-side inlet configuration and a right-side inlet configuration, and Includes, In the left-side inlet configuration, the inlet portion of the left-side member is received by the pipe connector, and the inlet portion of the right-side member is received by the hollow projection of the blank, In the right-side inlet configuration, the inlet portion of the right-side member is received by the pipe connector, and the inlet portion of the left-side member is received by the hollow projection of the blank.

[0126] In some embodiments, the conduit of each side member includes a portion that can be crushed, in an open configuration the crushable portion remains open, and in a closed configuration the crushable portion is compressed or flattened to close or substantially close the conduit.

[0127] In some embodiments, the frame is adapted to deform so that a force applied to the front of the frame elastically bends the frame, crushing the conduit of the member into a closed configuration.

[0128] In some embodiments, the frame is rotatably attached to the main body, and the frame is rotated relative to the main body to selectively configure the cannula between a left-side inlet configuration and a right-side inlet configuration.

[0129] In some embodiments, the frame includes a concave interior that accommodates a corresponding convex shape of the main body.

[0130] In some embodiments, the patient interface is a nasal cannula, and the body is a cannula body including a manifold and at least one nasal prong or nasal outlet extending from the manifold so as to be received in the user's nostril.

[0131] According to at least one of the embodiments disclosed herein, the patient interface includes a headgear, the headgear includes a pair of arms, each arm includes an earplug, each earplug is fitted to fit into the user's ear, and holds the patient interface in place on the user's face.

[0132] In some embodiments, one or both arms are adjustable in length.

[0133] In some embodiments, one or both arms are retractable, and one or both arms include a first part that is slidably received by a second part, and the length of the arms is adjusted by the relative movement of the first arm and the second arm.

[0134] In some embodiments, one of the first and second portions of each arm is integrally formed with a frame that is attached to the body of the patient interface.

[0135] In some embodiments, one of the first and second portions of the arm is rigider than the other of the first and second portions of the arm.

[0136] In some embodiments, the patient interface is a nasal cannula.

[0137] The term “conduit” is intended in this specification and in the claims to mean, in a broad sense, any member that forms or provides a lumen for directing the flow of gas, unless the context suggests otherwise. For example, a conduit or conduit portion may be part of a patient interface, or it may be a separate conduit that can be attached to a patient interface to provide a flow of gas to the patient interface.

[0138] The term "cross-section" of a conduit refers to a section perpendicular to the flow path of the conduit, for example, perpendicular to the flow path or longitudinal axis of the conduit. As a further example, the cross-section may be viewed from the end of the conduit.

[0139] Unless the context suggests otherwise, the thickness of a side or portion of a conduit cross-section is the thickness of the lateral wall of that side or portion of the cross-section. For example, the thickness at a point on the cross-section (i.e., a bend) is the minimum distance at that point that traverses the wall of the cross-section from the outer surface to the inner surface of the wall. For example, in Figure 6A, the thickness at bend 522 is the distance at bend 522 from the outer surface to the inner surface, along a line extending, for example, through the center of the cross-section, or a line extending across the cross-section through both bends 522 of the cross-section.

[0140] The term “comprising” in this specification and in the claims means “consisting of at least part of…”. When interpreting each sentence in this specification and in the claims that contains the term “comprising”, there may be other features besides those preceding the term. Related terms such as “comprise” and “comprises” should be interpreted in the same way.

[0141] References to the range of numbers disclosed herein (e.g., 1 to 10) also incorporate references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and also to rational numbers within any range within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore all subranges of the entire range are expressly disclosed herein and are intended to be expressly disclosed therein. These are merely examples of what is specifically intended, and all possible combinations of numbers between the lowest and highest values ​​listed should be considered expressly stated in this application as well.

[0142] In this specification, the term "and / or" means "and" or "or," or both.

[0143] In this specification, "(s)" following a noun indicates the plural and / or singular form of that noun.

[0144] Those skilled in the art will see that many structural modifications and the broadly different embodiments and applications of the present invention do not deviate from the scope of the invention as set forth in the appended claims. The descriptions in this disclosure and herein are purely illustrative and not intended to limit in any way.

[0145] This disclosure assumes the structures described above and given below only as examples.

[0146] Preferred embodiments of this disclosure are described only by reference to the following drawings. [Brief explanation of the drawing]

[0147] [Figure 1] This shows a respiratory therapy system. [Figure 2] This indicates a patient wearing a patient interface. [Figure 3]This shows a patient wearing a patient interface (first patient interface) and a face mask (second patient interface). [Figure 4] This shows a cross-section of a portion of the patient interface or conduit. [Figure 5] This shows a typical airway of a patient. [Figure 6A] Figure 6a shows a cross-section of the portion of the conduit that can collapse (across the conduit's flow path). Figure 6b shows a conduit in a first or open configuration, and Figure 6b shows a conduit in a second or closed configuration. [Figure 6B] Figure 6a shows a cross-section of the portion of the conduit that can collapse (across the conduit's flow path). Figure 6b shows a conduit in a first or open configuration, and Figure 6b shows a conduit in a second or closed configuration. [Figure 7A] This shows an alternative cross-section of the conduit portion that can be crushed. [Figure 7B] This shows an alternative cross-section of the conduit portion that can be crushed. [Figure 7C] This shows an alternative cross-section of the conduit portion that can be crushed. [Figure 8A] This shows an alternative cross-section of the conduit portion that can be crushed. [Figure 8B] This shows an alternative cross-section of the conduit portion that can be crushed. [Figure 8C] Figure 8a shows the possible collapsed profile of the cross-section. [Figure 8D] Figure 8b shows the possible collapsed profile of the cross-section. [Figure 9A] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9B] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9C] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9D] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9E] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9F] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9G] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 9H] The nasal cannula is shown. Figure 9A shows an oblique view, Figure 9B shows an exploded oblique view, Figure 9C shows a top (plan) view, Figure 9D shows an anterior view, Figure 9E shows a lateral view, and Figures 9F to 9H show top, anterior, and lateral perspective views, respectively. [Figure 10A] Figure 10A shows a perspective view of the cannula connector, Figure 10B shows an exploded perspective view, Figure 10C shows a top (plan) view, and Figure 10D shows a side view. [Figure 10B] Figure 10A shows a perspective view of the cannula connector, Figure 10B shows an exploded perspective view, Figure 10C shows a top (plan) view, and Figure 10D shows a side view. [Figure 10C]Figure 10A shows a perspective view of the cannula connector, Figure 10B shows an exploded perspective view, Figure 10C shows a top (plan) view, and Figure 10D shows a side view. [Figure 10D] Figure 10A shows a perspective view of the cannula connector, Figure 10B shows an exploded perspective view, Figure 10C shows a top (plan) view, and Figure 10D shows a side view. [Figure 11A] Figure 11A shows the separated connector components, Figure 11B shows the connected connector components, Figure 11C shows the components that rotate relative to each other to disengage, and Figure 11D shows a cross-section along line II in Figure 11C. [Figure 11B] Figure 11A shows the separated connector components, Figure 11B shows the connected connector components, Figure 11C shows the components that rotate relative to each other to disengage, and Figure 11D shows a cross-section along line II in Figure 11C. [Figure 11C] Figure 11A shows the separated connector components, Figure 11B shows the connected connector components, Figure 11C shows the components that rotate relative to each other to disengage, and Figure 11D shows a cross-section along line II in Figure 11C. [Figure 11D] Figure 11A shows the separated connector components, Figure 11B shows the connected connector components, Figure 11C shows the components that rotate relative to each other to disengage, and Figure 11D shows a cross-section along line II in Figure 11C. [Figure 12A] Figures 12A–12B show the soft parts of the user's face, and Figure 12C shows the cannula positioned across the soft parts of the user's face. [Figure 12B] Figures 12A–12B show the soft parts of the user's face, and Figure 12C shows the cannula positioned across the soft parts of the user's face. [Figure 12C] Figures 12A–12B show the soft parts of the user's face, and Figure 12C shows the cannula positioned across the soft parts of the user's face. [Figure 13A] The geometric shapes of two embodiments of the cannula are shown. [Figure 13B] The geometric shapes of two embodiments of the cannula are shown. [Figure 14A] This shows a cannula with an alternative headgear. [Figure 14B] This shows a cannula with an alternative headgear. [Figure 14C] This shows a cannula with an alternative headgear. [Figure 15] This is a perspective view of a cannula and a shield attached to the cannula, configured to support the cannula against crushing. [Figure 16A] The nasal cannula is shown. Figure 16A is a perspective view, Figure 16B is a front view, Figure 16C is an exploded view, Figure 16D is a perspective view showing the compliant cannula body rotated relative to a relatively rigid cannula member, and Figure 16E is a cross-section along line II in Figure 16B. [Figure 16B] The nasal cannula is shown. Figure 16A is a perspective view, Figure 16B is a front view, Figure 16C is an exploded view, Figure 16D is a perspective view showing the compliant cannula body rotated relative to a relatively rigid cannula member, and Figure 16E is a cross-section along line II in Figure 16B. [Figure 16C] The nasal cannula is shown. Figure 16A is a perspective view, Figure 16B is a front view, Figure 16C is an exploded view, Figure 16D is a perspective view showing the compliant cannula body rotated relative to a relatively rigid cannula member, and Figure 16E is a cross-section along line II in Figure 16B. [Figure 16D]The nasal cannula is shown. Figure 16A is a perspective view, Figure 16B is a front view, Figure 16C is an exploded view, Figure 16D is a perspective view showing the compliant cannula body rotated relative to a relatively rigid cannula member, and Figure 16E is a cross-section along line II in Figure 16B. [Figure 16E] The nasal cannula is shown. Figure 16A is a perspective view, Figure 16B is a front view, Figure 16C is an exploded view, Figure 16D is a perspective view showing the compliant cannula body rotated relative to a relatively rigid cannula member, and Figure 16E is a cross-section along line II in Figure 16B. [Figure 17] This is a perspective view of a nasal cannula. [Figure 18A] Figure 18A shows a front perspective view, Figure 18B shows a rear perspective view, Figure 18C is a cross-sectional view showing the operating lever in the open position, which allows gas to flow out of the nasal prongs of the cannula, and Figure 18D is a cross-sectional view showing the operating lever in the closed position, which blocks gas from flowing out of the nasal prongs of the cannula. [Figure 18B] Figure 18A shows a front perspective view, Figure 18B shows a rear perspective view, Figure 18C is a cross-sectional view showing the operating lever in the open position, which allows gas to flow out of the nasal prongs of the cannula, and Figure 18D is a cross-sectional view showing the operating lever in the closed position, which blocks gas from flowing out of the nasal prongs of the cannula. [Figure 18C] Figure 18A shows a front perspective view, Figure 18B shows a rear perspective view, Figure 18C is a cross-sectional view showing the operating lever in the open position, which allows gas to flow out of the nasal prongs of the cannula, and Figure 18D is a cross-sectional view showing the operating lever in the closed position, which blocks gas from flowing out of the nasal prongs of the cannula. [Figure 18D]Figure 18A shows a front perspective view, Figure 18B shows a rear perspective view, Figure 18C is a cross-sectional view showing the operating lever in the open position, which allows gas to flow out of the nasal prongs of the cannula, and Figure 18D is a cross-sectional view showing the operating lever in the closed position, which blocks gas from flowing out of the nasal prongs of the cannula. [Figure 19] This is an exploded view of the oral interface. [Modes for carrying out the invention]

[0148] Various embodiments will be described with reference to the drawings. Throughout the drawings and specification, the same reference numerals will be used to specify the same or similar components, and their redundant descriptions may be omitted.

[0149] Figure 1 shows a respiratory therapy system 100. The respiratory therapy system 100 includes a flow generator 102. The flow generator 102 is configured to generate a flow of gas, which is passed through the respiratory therapy system 100. The flow generator 102 passes air to a humidifier 104. The humidifier 104 is configured to heat and humidify the gas flow generated by the flow generator 102. In some configurations, the flow generator 102 includes a blower adapted to receive gases from the environment outside the respiratory therapy system 100 and propel those gases through the respiratory therapy system 100. In some configurations, the flow generator 102 may include some other gas generating means. For example, in some configurations, the flow generator 102 may include a source available from a hospital gas outlet (e.g., oxygen or air), or one or more containers of compressed air and / or another gas, and one or more valve devices adapted to control the rate at which gases exit one or more containers. As another example, in some configurations, the flow generator 102 may include an oxygen concentrator. In some configurations, the flow generator 102 may be adapted to provide high-flow therapy.

[0150] According to the various configurations and embodiments described herein, the flow rate of gas supplied or provided to the interface or through the system, such as through the flow path, may include, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 L / min, and the effective range may be selected between any of these values ​​(e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L / min, about 70 to about 80 L / min). In some embodiments, flow rates exceeding about 15 L / min, in particular, but not limited to, flow rates of about 60 to 70 L / min, etc., may be used in such configurations or embodiments. "High-flow" or "high-flow therapy" may refer to the delivery of gas to a patient at a flow rate of approximately 5 or 10 L / min to approximately 100 L / min, or approximately 15 L / min to approximately 95 L / min, or approximately 20 L / min to approximately 90 L / min, or approximately 25 L / min to approximately 85 L / min, or approximately 30 L / min to approximately 80 L / min, or approximately 35 L / min to approximately 75 L / min, or approximately 40 L / min to approximately 70 L / min, or approximately 45 L / min to approximately 65 L / min, or approximately 50 L / min to approximately 60 L / min.

[0151] The supplied gas may contain a certain percentage of oxygen. In some configurations, the percentage of oxygen in the supplied gas may be approximately 20% to 100%, or approximately 30% to 100%, or approximately 40% to 100%, or approximately 50% to 100%, or approximately 60% to 100%, or approximately 70% to 100%, or approximately 80% to 100%, or approximately 90% to 100%, or approximately 100%, or 100%.

[0152] High-flow therapy has been shown to be effective when it matches or exceeds a patient's normal peak inspiratory demand in order to increase the patient's oxygen supply and / or reduce their work of breathing. Furthermore, high-flow therapy can generate a flushing effect in the nasopharynx, causing the anatomical dead space of the upper airway to be flushed by the high flow of incoming gas. This can create a reservoir of fresh gas available with each breath, while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0153] Since relatively high flow rates of gas delivery may be used in the embodiments or configurations described herein, the gas being supplied or delivered to the user or patient may be delivered to different parts of the user's or patient's airway.

[0154] Such relatively high flow rates of gas can help deliver the supplied gas to the user's airway or to different parts of the user's airway; for example, such a flow rate may allow the gas to be delivered to the upper or lower airway region. The upper airway region generally includes the nasal cavity, pharynx, and larynx, while the lower airway region generally includes the trachea, primary bronchi, and lungs.

[0155] Figure 5 shows a typical human airway and includes arrows indicating how relatively high flow rates of gas supplied to the user are utilized to effectively push or flush the supplied gas further or deeper into the user's airway than when the person is in a normal or typical self-driven breathing state or when the patient's respiratory drive is reduced.

[0156] The respiratory therapy system 100 includes a housing 106 that at least partially accommodates both the flow generator 102 and the humidifier 104 (for example, the respiratory therapy system 100 may include an integrated flow generator / humidifier). In other configurations, the flow generator 102 and the humidifier 104 may have separate housings. A hardware controller 108 that electronically communicates with the flow generator 102 and the humidifier 104 is shown, but in some configurations, the hardware controller 108 may communicate only with the flow generator 102 or the humidifier 104. The hardware controller 108 may include a microcontroller or some other architecture configured to command the operation of the controllable components of the respiratory therapy system 100, including but not limited to the flow generator 102 and / or the humidifier 104. An input / output module 110 that electronically communicates with the controller 108 is shown. The input / output module 110 may be configured to allow the user to interface with the controller 108 to facilitate control of controllable components of the respiratory therapy system 100, including but not limited to the flow generator 102 and / or humidifier 104, and / or to view data relating to the operation of the respiratory therapy system 100 and / or its components. The input / output module 110 may include, for example, one or more buttons, knobs, dials, switches, levers, touchscreens, speakers, displays and / or other peripheral devices for input or output that the user can use to view data, and / or input commands for controlling components of the respiratory therapy system 100.

[0157] Furthermore, as shown in Figure 1, an auxiliary gas source 124 may be used to add one or more auxiliary gases to the gas flowing through the respiratory therapy system 100. One or more auxiliary gases join the gas flow generated by the flow generator 102. The auxiliary gas source 124 may be configured to supply one or more auxiliary gases, including but not limited to air, oxygen (O2), carbon dioxide (CO2), nitrogen (N2), nitrous oxide (NO), and / or heliox (a mixture of helium and oxygen). The auxiliary gas source 124 may supply one or more auxiliary gases to a location upstream of the flow generator 102 via a first auxiliary gas conduit 128, and / or one or more auxiliary gases to a location downstream of the flow generator 102 and / or upstream of the humidifier 104 via a second auxiliary gas conduit 132. One or more auxiliary flow valves 126, 130 can be used to control the flow rate at which one or more auxiliary gases can flow from the auxiliary gas source 124 through the first and / or second auxiliary gas conduits 128, 132. One or more of the auxiliary flow valves 126, 130 may communicate electronically with a controller 108, which can then control the operation and / or state of one or more of the auxiliary flow valves 126, 130. In other configurations, the auxiliary gas source 124 may be configured to add one or more auxiliary gases downstream of the humidifier 104.

[0158] As shown in Figure 1, a conduit 112 extending from the humidifier 104 connects the humidifier 104 to the patient interface 200. The conduit 112 may include a conduit heater 114 adapted to heat the gas passing through the conduit 112. In other configurations, the conduit heater 114 may not be present. Although the patient interface 200 is shown as a nasal cannula, it should be understood that in some configurations other patient interfaces may be preferable. For example, in some configurations, the patient interface 200 is a nasal cannula. closed type or non-crowded closed typeThe interface may include a nasal mask, oral mask, mouth-nasal mask, full-face mask, nasal pillow mask, nasal cannula, endotracheal tube, tracheostomy tube, a combination of the above, or any other gas delivery system. In a preferred embodiment, the patient interface 200 is a non-contact device such as a nasal cannula. closed type It is an interface that allows gas to be exchanged with the environment. For example, non-congested closed type The cannula can remove and / or clear carbon dioxide from the patient's airway while the patient is receiving flow therapy from system 100. Furthermore, in some preferred embodiments, the patient interface 200 is in the form of a nasal interface, so that the system does not interfere with other oral airway equipment and / or devices, such as a tracheal tube, during intubation procedures. Thus, the patient can continue to receive flow therapy throughout the intubation procedure. In other embodiments, the patient interface 200 is an oral interface, such as an oral interface that is received in the user's mouth. An oral interface may be preferred in situations involving medical procedures via the nose, so that the interface does not interfere with nasal airway equipment and / or devices, such as a tracheal tube used in nasal intubation procedures. In other embodiments, the interface may be preferred for both nasal and oral placement, or adapted between a nasal configuration and an oral configuration. An exemplary oral interface is shown in Figure 19.

[0159] As shown in the diagram, in some configurations, the patient interface 200 may also include a gas sensing module 120 adapted to measure the characteristics of the gas passing through the patient interface 200. In other configurations, the gas sensing module 120 may be positioned and adapted to measure the characteristics of the gas in or near other parts of the respiratory therapy system 100. The gas sensing module 120 may include one or more sensors adapted to measure various gas characteristics, including but not limited to pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration, and / or nitrogen concentration. The gas characteristics determined by the gas sensing module 120 may be used in several ways, including but not limited to closed-loop control of the gas parameters. For example, in some configurations, flow rate data obtained by the gas sensing module 120 may be used to determine instantaneous flow rate, which can also be used to determine the patient's respiratory cycle to facilitate the delivery of a synchronized flow over multiple parts of the respiratory cycle. The gas sensing module 120 can communicate with the controller 108 through a first transmission line 122. In some configurations, the first transmission line 122 may include a data communication connection adapted to transmit data signals. The data communication connection may include, but is not limited to, a wired data communication connection such as a data cable, or, but is not limited to, a wireless data communication connection such as Wi-Fi or Bluetooth. In some configurations, both power and data may be communicated through the same first transmission line 122. For example, the gas sensing module 120 may include a modulator that can allow data signals to be "overlaid" on top of power signals. The data signals may be superimposed on the power signals, and the combined signals may be demodulated before being used by the controller 108. In other configurations, the first transmission line 122 may include a pneumatic communication connection adapted to transmit gas flows for analysis in a portion of the respiratory therapy system 100.

[0160] Furthermore, as shown in the figure, a physiological sensor module 121 may be present. The physiological sensor module 121 may be configured to detect various characteristics of the patient or the patient's health condition, including but not limited to heart rate, EEG signal, EKG / ECG signal, inertial sensors attached to the patient (e.g., chest) to detect movement, blood oxygen concentration (e.g., by a pulse oximeter), blood CO2 concentration, transcutaneous CO2 (TcCO2), and / or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 through a second transmission line 123. The second transmission line 123 may include a wired or wireless data communication connection similar to the first transmission line 122, and power and data may be communicated similarly. The physiological sensor module 121 may be used, for example, to determine the patient's blood oxygen saturation.

[0161] Figure 2 shows a user or patient P wearing a patient interface 200, for example, the patient interface 200 of the respiratory system shown in Figure 1. The patient shown is an adult, but the patient may be an infant or child. In the non-limiting configuration shown, the patient interface 200 is a nasal cannula. The patient interface 200 includes a first gas conduit 202. The first gas conduit 202 is adapted to receive gas from the respiratory therapy system 100 (for example, via the conduit 112 shown in Figure 1) and to deliver the gas to patient P. The first gas conduit 202 may include a reinforcing element 203 adapted to reinforce and / or add rigidity to the first gas conduit, preventing deformation or collapse of the first gas conduit 202 resulting from the application of force to the first gas conduit 202. The reinforcing element 203 may include, but is not limited to, plastic or metal reinforcing beads located within or on the wall of the first conduit lumen 202.

[0162] A first gas conduit 202 is in air communication with a flow manifold 206. The flow manifold 206 receives gas from the first gas conduit 202 and delivers it to one or more nasal delivery elements 208 (e.g., nasal prongs). One or more nasal delivery elements 208 extend outward from the flow manifold 206. One or more nasal delivery elements 208 are fitted to be positioned unsealed in one or more nostrils of patient P. As shown in the figure, the patient interface 200 includes two nasal prongs 208, one of which is fitted to be positioned in each of the patient's nostrils. Each nasal prong 208 may be shaped or angled to extend inward toward the patient's nasal septum. Alternatively, the first patient interface 200 may be tightly sealed closed type It can be used as a nasal interface.

[0163] In the embodiment shown in Figure 2, the flow manifold 206 receives the flow from one side of the flow manifold 206 (for example, with respect to a virtual vertical plane that bisects the face of patient P) and delivers the flow to the manifold and to each nasal prong 208. In some embodiments, the conduit may extend from the left or right side of the manifold. In some situations, providing the conduit on the left side of the patient interface may be preferable for the clinician to access it, for example, for intubation. Alternatively, in procedures such as endoscopy, where the patient is generally in a left lateral decubitus position, a conduit extending from the right side may be preferable. In other configurations, the patient interface 200 may include more (e.g., 3 or 4) or fewer (e.g., 1) nasal delivery elements 208. In other configurations, each nasal delivery element 208 may have different characteristics. For example, one of a pair of nasal delivery elements 208 may be relatively long, and the other nasal delivery element 208 may be relatively short.

[0164] In some configurations, the flow manifold 206 may be configured to receive flow from two sides of the flow manifold 206 (for example, from the “left” and “right” sides of the flow manifold 206, instead of just the patient’s right side of the flow manifold 206 as shown in Figure 2). In some such configurations, multiple gas conduits may be used to provide air communication between the flow manifold 206 and the respiratory therapy system 100. For example, the patient interface may include a double conduit, where a first gas conduit 203 extends from a first side of the interface (the patient’s right side in the illustrated example), and a second gas conduit extends from a second side opposite the interface. In some configurations, the flow manifold 206 may be configured to receive flow from a non-side of the flow manifold 206 (for example, from the “bottom” or “top” of the flow manifold 206).

[0165] The patient interface may further include mounts and / or supports, such as cheek supports 210, for attaching and / or supporting one or more gas conduits 202 to the patient's face. Alternatively or in addition, the patient interface may be held in place via one or more head straps or headgear.

[0166] The first gas conduit 202 of the patient interface 200 includes a first portion 204, the first portion being configured to transition from a first configuration in which a first level of gas can pass through the first portion 204 to a second configuration in which a second level of gas can pass through the first portion 204.

[0167] Figure 3 shows a non-limiting exemplary embodiment of patient P wearing a patient interface 200 (first patient interface) as shown in Figure 2, attached to the lower part of a face mask 300 assembly (second patient interface). Figure 3 schematically shows the face mask as a transparent structure with the patient interface 200 located beneath it. The first patient interface 200 may be used in conjunction with a first respiratory support subsystem, and the second patient interface 300 may be used in conjunction with a second respiratory support subsystem.

[0168] The system may be found to have the advantage of being able to selectively provide patients with different treatments using different patient interfaces, and / or to stop or terminate the delivery of treatments from the interface, and / or to allow sampling of gases provided by the interface. Systems and devices such as those described are particularly applicable to emergency resuscitation related to intubation in patients undergoing high-flow therapy, ear, nose, and throat (ENT) surgery, and assisting in the adjustment of the patient's preoperative condition before anesthetic administration, and during extubation and recovery.

[0169] The face mask assembly 300 may be used as a second respiratory support subsystem or together with it, and / or to deliver one or more substances other than those delivered by the cannula 200, such as anesthetics or oxygen, to the patient, or the same substances but at different flow and / or pressure levels. Alternatively, the face mask assembly 300 may be used to stop the delivery of treatment from the first respiratory support subsystem. The face mask assembly 300 may also be adapted to measure respiratory gases, such as carbon dioxide exhaled from the patient, otherwise its measurement may be affected by the flow from the patient interface 200 of the first respiratory support subsystem.

[0170] Therefore, the embodiment shown in Figure 3 allows for the substitution of two different respiratory support subsystems. Furthermore, this configuration may allow the patient interface 200 to remain with the patient throughout the surgical procedure and / or until recovery without interfering with other clinical practice (regardless of whether the patient continues to receive flow therapy via the patient interface 200 throughout the procedure).

[0171] In the illustrated embodiment, the face mask assembly 300 includes a full face mask 302 configured to cover both the patient's nose and mouth. In other configurations, the face mask 300 may be a nasal mask positioned above the patient interface 200 to cover only the patient's nasal area.

[0172] As shown in the figure, the face mask 302 includes a sealing area 304 adapted to seal against the patient's face. The face mask assembly 300 is connected to a second gas source, for example via a filter element 350, to supply one or more other gases to the patient through the face mask. That is, the second gas source is preferably different from the gas supply source to the patient interface 200 (e.g., auxiliary gas source 124 / flow generator 102).

[0173] In a preferred embodiment, the face mask assembly 300 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support device may be a ventilator or CPAP or high-flow therapy device or a manual resuscitation device (e.g., a handheld face mask with a bag). Alternatively or in addition, the face mask assembly 300 may be connected to an instrument for measuring the characteristics of the respiratory gas.

[0174] Alternatively, the mask assembly 300 may be connected to an anesthesia device, and an anesthetic gas, or air, or oxygen, or a combination of gases may be delivered via the mask 302.

[0175] The embodiment shown in Figure 3 enables the delivery of gas from multiple sources through at least two different respiratory support modes, and further allows a physician, clinician, or healthcare professional to quickly and easily change the type of respiratory support mode.

[0176] In one specific application, a patient being prepared for anesthesia may be pre-oxygenated by delivering high-flow oxygen, humidified gas, or a mixture of both via a nasal cannula. Depending on the situation, the anesthesiologist managing the patient's sedation may want to switch between delivering the gas flow from one patient interface (e.g., nasal cannula 200) and delivering the gas flow from another patient interface, such as via a face mask 300.

[0177] Anesthesiologists also find it beneficial to use a bag-mask to oxygenate a patient, and in some cases, to use a bag-mask when the patient's vital signs begin to decline, for example, when it is necessary to deliver higher pressure or have better control over the fluctuations in the delivered pressure. In some situations, medical professionals may want to switch between different respiratory systems or support modes. In the first mode, respiratory support may be provided by a first respiratory support system (e.g., via the patient interface 200), and in the second mode, respiratory support may be provided by a second respiratory support system (e.g., via the patient interface 300), with the support from the first system being switched off. For example, it may be advantageous to be able to stop the additional flow from the first respiratory system, as the additional flow from the high-flow provided by the nasal interface 200 may also modify the expected behavior of the anesthetic circuit provided by the face mask 300.

[0178] In some configurations, switching between two respiratory support modes or subsystems can be facilitated by the structure of a first gas conduit 202 having a first portion 204, which is configured to transition from a first configuration in which a first level of gas can pass through the first portion 204 to a second configuration in which a second level of gas can pass through the first portion 204.

[0179] In some configurations, the first section 204 is configured to be more collapsible than the other sections of the conduit 202, or otherwise to fit better, in order to alter the flow of gas through the first section 204 (and thus reduce the flow of gas to the patient through the conduit) and / or to allow the mask seal to seal across the upper side of the conduit. In other configurations, the entire conduit may be configured to be collapsible. In some configurations, a vent configuration is provided upstream of the collapsible section to allow gas to vent from the conduit upstream of the collapsible section to the atmosphere.

[0180] In some embodiments, the first configuration or first condition is substantially an open configuration, and the second configuration or second condition is substantially a closed configuration. That is, the conduit 202 is configured to be more collapsible, deformable or otherwise adaptable so as to completely block the flow in the first portion 204 than in other portions of the conduit 202.

[0181] Figure 4 shows an example of this configuration, where the conduit in the first section 204 (e.g., the conduit 202 of the nasal cannula 200 in Figure 3) is substantially closed by the seal 304 of the face mask 302. In such embodiments, the length of the first section of the first gas conduit (i.e., the more collapsible or deformable section) must be greater than the width of the section of the face mask seal that rests over the first section of the first gas conduit. This ensures that the face mask seal does not rest over the non-collapsible portion of the first gas conduit. For example, the first section may extend from a distance of 35 mm or less from the center of the user's nose to at least 50 mm from the center of the user's nose, and the length of the first section is at least 15 mm. In some embodiments, the length of the first section may be at least 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm or more.

[0182] The first portion 204 can move between the first and second configurations based on the level of relative force applied to the wall of the first portion 204. For example, as shown in Figure 3, the force can be applied by the seal 304 of the face mask 302. In this example, the first portion 204 is configured to be positioned below the seal 304 of the face mask 302.

[0183] Alternatively, force may be applied to the first portion 204 by other means, such as a clamp (not shown), or instead, the physician may compress the conduit by pressing on the conduit wall with his finger or thumb.

[0184] In some embodiments, a face mask seal acting on a first portion of the gas conduit causes the first portion to form a seal or at least a partial seal between the nasal outlet of the first patient interface 200 and the flow generator 102. Furthermore, the face mask seal covers the upper side of the first portion of the gas conduit to form a seal or at least a partial seal.

[0185] Therefore, since switching between respiratory support therapies is achieved simply by applying a mask to the patient's face, the mask seal crushes (partially or completely) the first portion of the gas conduit of the first interface 200 to “stop” or reduce the therapy supplied by the first interface 200, and also provides a seal between the face mask 300 and the outer surface of the first portion 204 of the conduit 202 so that the therapy can be supplied by the mask 300 while blocking the therapy supplied by the first interface. A cannula with a conduit portion that can be crushed allows a user, e.g., an anesthesiologist or nurse or clinician, to use the mask and prevent the delivery of gas from multiple sources (e.g., the mask and the cannula). The first interface 200 is structured and functions to prevent the delivery of high-flow therapy and other respiratory therapies or anesthetic gases through the mask. In some embodiments, the therapy supplied by the first interface can be resumed when the conduit returns from a crushed configuration to an open configuration by removing the mask from the patient's face.

[0186] Figures 6a and 6b show cross-sections of the collapsible portion of the conduit 500, which may be integrally formed with and part of a patient interface, such as a high-flow cannula. Figure 6a shows the conduit 500 in a first or open configuration, and Figure 6b shows a cross-section of the same conduit 500 in a second or collapsible / closed configuration. In the open configuration, gas can flow along the conduit, and in the closed configuration, the collapsible portion is substantially sealed / occluded, so the flow of gas along the conduit is substantially stopped.

[0187] In the embodiment of Figure 6a, the cross section of the collapsible portion of the conduit 500 includes a first side 511 with a flat portion 510 for positioning relative to the user's face. The flat portion is intended to assist in positioning the conduit on the user's face, for example, in holding the tube in the correct orientation on the user's face when a mask is applied over the top of the tube, and / or assist in moving the conduit from an open configuration to a closed configuration. The flat portion may assist in placing the conduit on the user's face and provide a stable mounting surface. The second side 512 of the conduit is opposite the first side and faces outward when viewed from the user's face. The first and second sides are joined by first and second bends 521 and 522. In the open configuration, the bends are spaced apart from the flat portion of the first side and therefore from the user's face. In an alternative embodiment (not shown), the bends may be coplanar with the flat section. A collapsible cross section may be one where the bending point is adjacent to or rests on the face. In the configuration shown in Figure 6A, the collapsible portion can be folded flat by having equal internal lengths in the first and second sides.

[0188] In a partially closed or closed configuration, the second side is moved toward or toward the first side, with the collapsible portion overlapping at the first and second bends. In a closed configuration, the bends 521, 522 may be moved toward or adjacent to the user's face. To assist in closing the conduit by sealing, the closed configuration helps to provide a substantially flat conduit that substantially prevents the flow of gas along the conduit and / or allows the mask seal to seal, with the inner lengths of the first side between the bends and the inner lengths of the second side between the bends being substantially equal. This configuration may help to achieve a substantially flat configuration, or a configuration in which the inner surfaces of the first and second sides of the conduit are in substantially complete contact along their lengths (e.g., without bubbles, ripples, or wrinkles), when in a closed or collapsed configuration as shown in Figure 6b. The first and second bends define or define the extent of the first and second sides. In other words, the first and second sides each extend completely between the inflection points, for example, from the first inflection point to the second inflection point. For example, the length of the first side 511 between inflection points 521 and 522 is shown in Figure 6A by a double arrow 511a, and the length of the second side 512 between inflection points 521 and 522 is shown in Figure 6A by a double arrow 512a.

[0189] In some embodiments, when in an open configuration, the first side may include outwardly curved or arched portions 531, 532 between the flat portion 510 and the first and second inflection points 521, 522, respectively. The two curved portions 531, 532 preferably have the same radius of curvature so that the collapsible section has mirror symmetry about the centerline of the cross section. Preferably, the cross section has mirror symmetry about the centerline of the cross section, and the centerline extends through the centers of the first and second sides of the cross section. Having a symmetrical cross section can help ensure that the collapsible portion, which collapses into a flat shape with a minimum height profile, facilitates the sealing of the mask seal over the conduit being collapsed. In some embodiments, the curvature of the outwardly curved or arched portions 531, 532 has a sufficiently large radius to prevent or reduce the formation of folds or gaps between the first and second sides in the conduit when in a collapsed configuration. In some embodiments, the outward curvature or arched portion 531, 532 may help maintain the cross-section in an open configuration when no external force is applied. In some embodiments, the outward curvature or arched portion 531, 532 may help reduce resistance to flow in the cross-section by increasing the cross-sectional area and reducing the sharpness of the interior angles.

[0190] In alternative configurations, the curved or arched portions 531, 532 may be curved inward, or the portions of the cross-section between the flat portion and each bending point may be straight or not curved.

[0191] In some embodiments, the thickness of the curved portions 531, 532 tapers from a thicker thickness toward the respective bending points 521, 522 from the flat portion 510. The change in thickness is preferably progressive along the length of the side of the cross section to reduce or prevent the formation of creases or folds toward the side away from the bending points 521, 522. Preferably, the thickness of the flat section is greater than the thickness of the rest of the first side of the cross section. The thicker flat portion provides additional structure to the conduit in the area that comes into contact with the user's face, so that the conduit does not wrinkle, buckle, or fold on the user's face, and thereby does not reduce the effectiveness of the closure by sealing the conduit when it is in a closed configuration.

[0192] In some configurations, as shown in Figure 6a, the second side 512 of the conduit is curved outward when in an open configuration. In some configurations, the second side 512 is a continuous curved or arched portion, for example, the second side curves outward from a first bend to a second bend. In some embodiments, the curvature of the second side may be substantially a single radius of curvature. In some configurations, the thickness of the second side 512 is tapered from a thicker thickness to a thinner thickness toward each bend 521, 522. In some embodiments, the second side is thickest at the center or apex of the curved second side. The outward curvature of the second side reduces resistance to flow compared to having a cross-sectional feature that curves or extends inward toward the center of the cross-section.

[0193] Preferably, the thickness of the bends 521, 522 is thinner than the thickness of the rest of the cross-section of the collapsible portion. The relatively thin section of the bend allows the section to transition between the open and closed configurations, particularly adapting to folding or bending at the bend. The conduit moves between the open and closed configurations, preferentially bending or folding at the bend. The thickness of the bends relative to the thickness of the other sections of the collapsible portion allows the collapsible portion to be flattened, preferably so that the collapsed portion substantially seals, substantially stopping flow through the conduit, and further, also facilitates the mask seal to seal across the top of the conduit and at the edges of the collapsed portion at the user's face. The thin bends, combined with the outward curvature of the second side, may facilitate a gradual taper of the collapsed portion from the center of the cross-section toward the user's face in the collapsed configuration, reducing the possibility of leakage between the conduit and the mask seal and the user's face.

[0194] In some embodiments, in the open configuration, the first side adjacent to each inflection point is at an angle to the flat portion 510, and the outer angle (α) between the first side adjacent to the inflection point and the flat portion 510 can be less than 80 degrees, or less than 75 degrees, or less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or between 50 and 70 degrees, or between 60 and 70 degrees, or about 65 degrees. For example, in Figure 6a, the angle is shown to be 62.6 degrees.

[0195] In some configurations, the first side flares outward on both sides of the flat portion 510 toward the respective inflection points 521, 522. Preferably, the first side curves toward (or toward) the flat portion 510 so that the cross section has no defined “corners or angles” in each range of the flat portion. Sharp corners within the first side of the edge of the flat portion can cause upward buckling on the lower surface of the cross section, creating a gap between the conduit and the face when in a collapsed configuration.

[0196] As described above, in some embodiments, the flat portion may be thicker than other parts of the cross-section. For example, in some embodiments, the thickness of the flat portion may be about 0.5 mm. In some embodiments, the thickness of the inflection point may be about 0.2 mm. In some embodiments, the thickness of the flat portion may be 0.5 mm to 1.5 mm. In some embodiments, the thickness of the inflection point may be 0.2 to 0.4 mm.

[0197] In some configurations, the ratio of the relative thickness between the (thicker) centers of the first and / or second sides of the cross section and the (thinner) inflection points may be in the range of approximately 1 to 8, or approximately 1.5 to 3.5. In some configurations, the ratio of the relative thickness between the (thicker) flat portions of the first side and / or the vertices of the second side of the cross section and the (thinner) inflection points may be in the range of approximately 1 to 8, or approximately 1.5 to 3.5. In some configurations, the ratio of the thickest part of the cross section to the thinnest part of the cross section, which is the inflection point, is in the range of approximately 1 to 8, or approximately 1.5 to 3.5. If the ratios described are greater than the described ranges, the thickest part of the cross section may reduce the flexibility of the portion that can be crushed. If the ratio falls below the stated range, the conduit may be too thin and may collapse under its own weight and / or develop creases, folds, or wrinkles in areas other than the bending points, which is undesirable for sealing the conduit and also for sealing the mask over the top of the conduit. However, to ensure flexibility when used by the user, the walls of the collapsed sections should be thin enough so that the conduit is comfortable against the user's face. The ratios mentioned above relate to the tested materials, which are silicone and thermoplastic polyurethane with a Shore hardness of 60-70A.

[0198] As in the exemplary embodiments, in some configurations, the length of the flat portion is about 5 mm to 10 mm or about 7 mm, and / or the width of the cross-section of the portion that can be crushed is 10 mm to 15 mm or about 13 mm. The distance between the bending points is greater than the width of the flat portion. In alternative embodiments, the first side does not have a flat portion 510. For example, the first side is curved between bending points, and the curve (which may include one or more radii of curvature) may extend from one bending point to the other.

[0199] Figures 7a–7c show alternative cross-sections of the collapsible conduit portion. Referring to Figure 7a, the cross-section includes a first side portion 611 for positioning against the user's face and a second side portion 612 opposite the first side portion and facing outward from the user's face. Unlike the previously described embodiment, which includes a flat portion 510, the embodiment in Figures 7a–7c does not have a flat portion on the first side portion 611. The first and second side portions are joined by first and second inflection points 621, 622. The first and second inflection points define or define the extent of the first and second side portions; in other words, the first and second side portions each extend completely between the inflection points, for example from the first inflection point to the second inflection point. In the illustrated embodiment, the maximum width of the cross-section is defined by the distance between the inflection points.

[0200] In the illustrated embodiment, the cross section is shaped such that, in the open configuration, the inflection points 621, 622 are spaced apart from the user's face. The first and second sides 611, 612 are curved outward when in the open configuration, so the cross section is substantially oval or elliptical; however, in contrast to a true oval or elliptical shape with rounded ends on the principal axis of the oval or ellipse, in the cross sections of Figures 7a-7c, the first and second sides converge to a certain point at each inflection point of the cross section. When in the open configuration, the inflection points are spaced apart from the user's face, and in the closed configuration, the inflection points are moved to be in contact with or adjacent to the user's face.

[0201] In some embodiments, as shown, for example, in Figures 7b and 7c, the bending point is the thinnest point of the cross section, so that the collapsible portion preferentially folds at the bending point when collapsing into a closed configuration. In some configurations, as shown, for example, in Figures 7b and 7c, the thickness of the first side and / or second side tapers from thicker to thinner towards each bending point. The maximum thickness is preferably at the respective vertices 641, 642 of the first side and the second side, respectively. In some configurations, the thickness at the bending point is thinner than the thickness of the rest of the cross section of the collapsible portion. In some configurations, as described below with respect to the embodiment in Figure 8b, for example, the cross section may include an internal notch (780 in Figure 8b), so the thickness at the bending point is thinner compared to the rest of the cross section. In some configurations, as shown in Figure 7c, the second side is thinner than the first side, which may cause the second side to collapse toward the first side when pressed by the mask seal.

[0202] In some embodiments, the ratio of the relative thickness between the (thicker) center of the first and / or second side of the cross section and the (thinner) flex point is in the range of about 1 to 8, or about 1.5 to 3.5. In some configurations, the ratio of the thickest part of the cross section to the thinnest part of the cross section, which is the flex point, is in the range of about 1 to 8, or about 1.5 to 3.5. As described above with respect to the previous embodiments, if the ratios described are greater than the ranges described, the thickest part of the cross section may reduce the flexibility of the part that can be crushed. If the ratios are less than the ranges described, the conduit may be too thin and may be crushed under its own weight and / or may develop creases, folds or wrinkles in areas other than the flex point, which is undesirable for sealing the conduit and also for sealing the mask seal over the conduit.

[0203] As described above with respect to the embodiments previously explained, it is desirable that the cross section, when in a closed configuration, achieve a flat shape that substantially closes the lumen of the conduit and allows the mask seal to be placed and seals against the conduit and the user's face. To help achieve a flat shape, when in a closed configuration, the cross section may include several other features. For example, in some embodiments, the cross section has mirror symmetry with respect to a line 650 extending through first and second inflection points. In some embodiments, the inner length 611a of the first side between the inflection points and the inner length 612a of the second side between the inflection points are substantially equal. In some embodiments, the collapsible section has mirror symmetry with respect to a centerline of the cross section (e.g., line 660 in Figure 7b), the centerline extending through the centers of the first and second sides of the cross section. Such features may help achieve a flat shape by avoiding creasing or folding outside of the inflection points.

[0204] Referring to Figure 7a, in some configurations, when in an open configuration, a line 670 tangential to a first side portion adjacent to each inflection point is at a certain angle with respect to a line 650 extending through the first and second inflection points, such that the angle (β) between that line and the portion adjacent to the inflection point is less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or between 30 and 60 degrees, or between 40 and 50 degrees, or about 45 degrees. Making this angle (β) acute helps to flatten the cross section.

[0205] Figures 8a and 8b show further alternative cross-sections of the conduit portion that can be crushed. In some embodiments, the cross-section may be substantially rhombic or parallelogram-shaped. In Figures 8a and 8b, the illustrated cross-section is substantially parallelogram-shaped, but those skilled in the art will understand that the features of the parallelogram-shaped cross-section described below may also apply to the rhombic-shaped cross-section unless the context suggests otherwise. The four corners, or angles, of the parallelogram-shaped cross-section provide inflection points 421–424. In the open configuration, the four sides of the parallelogram are spaced apart, and in the closed configuration, the cross-sections fold at corners 421, 422, 423, and 424 so that adjacent sides of the parallelogram come into contact. In the closed configuration, corners 421 and 422, which include acute interior angles, are located on the edges of the crushed cross-section.

[0206] In some embodiments, the cross section is positioned so that the longer sides of the parallelogram are in contact with the user's face during use. Positioning the longer sides in contact with the user's face can help ensure that the conduit is properly placed so that it collapses due to the mask seal pressing across the top of the conduit. Placing the longer sides in contact with the face also reduces the profile of the portion of the conduit that can collapse on the user's face, providing a cleaner, more aesthetically pleasing, and less intrusive appearance. However, in some embodiments, the cross section may be configured so that the shorter sides of the parallelogram are in contact with the user's face. This can be particularly useful for use with infants, as infants and children have a limited facial area to support the conduit.

[0207] To facilitate the collapse of the conduit, preferably the acute corner angles of the parallelogram are less than 70 degrees, or less than 65 degrees, or less than 60 degrees, or less than 55 degrees, or less than 50 degrees, or less than 45 degrees, or less than 40 degrees, or less than 35 degrees, or less than 30 degrees, or between 45 and 65 degrees, or between 55 and 65 degrees, or may be about 60 degrees.

[0208] As mentioned above, preferably, the inflection points have a thinner cross-section than the rest of the cross-section. In some configurations, the thickness of the sides of the parallelogram (or rhombus) can be tapered from thicker to thinner towards each corner (inflection point) 421, 422 at an acute angle. In some configurations, the thickness of the acute corners (inflection points) is thinner than the thickness of the rest of the cross-section of the portion that can be crushed. As shown in Figure 8b, the cross-section may include an acute internal notch 480 at the corners 421, 422, so the thickness at the acute corners 421, 422 is thinner than the thickness of the sides 411, 412 of the cross-section. The thickness of the obtuse corners 423, 424 may be similar to the thickness of the sides of the cross-section. In some configurations, the thickness of the sides of the rhombus or parallelogram is about 0.5 mm to 1.0 mm, or about 0.7 mm, and the thickness of the acute corners is about 0.2 mm.

[0209] In some embodiments, the first side 411 of the cross section extends between two acute corners 421, 422 or a point of inflection, and the first side includes two adjacent parallelogram sides 411(i) and 411(ii), and an obtuse corner 423. The opposing second side 412 of the cross section extends between two acute corners 421, 422 or a point of inflection, and the second side includes two adjacent parallelogram sides 412(i) and 412(ii), and an obtuse corner 424. In some embodiments, the inner length 411a of the first side between the points of inflection 421, 422 and the inner length 412a of the second side between the points of inflection 421, 422 are substantially equal. In some configurations, the second side 422 is thinner than the first side 421.

[0210] In some configurations, the ratio of the relative thickness of the (thicker) side of the cross section to the (thinner) inflection point is in the range of approximately 1 to 8, or approximately 1.5 to 3.5, or the ratio of the thickest part of the cross section to the thinnest part of the cross section, which is the inflection point, is in the range of approximately 1 to 8, or approximately 1.5 to 3.5.

[0211] In some embodiments, the side 411(i) of the parallelogram cross-section that rests in contact with the user's face is thicker than the other sides. For example, side 411(i) may be thicker than the adjacent side 411(ii) joined to side 411(i) by an obtuse angle of the parallelogram, and / or side 411(i) may be thicker than the adjacent side 412(ii) joined to side 411(i) by an acute angle of the parallelogram, and / or side 411(i) may be thicker than the side 412(i) opposite to side 411(i). In some embodiments, the ratio of the thickness of the thinner side of the cross-section to the thickness of side 411(i) (i.e., the base of the cross-section) is in the range of 0.3 to 0.7. In one preferred embodiment, the ratio is 0.5. For example, in one embodiment, the base 411(i) of the parallelogram is approximately 1.4 mm thick, and the thickness of the other sides is approximately 0.7 mm.

[0212] In some embodiments, the ratio of the length of the base (side portion 411(i) that contacts the user's face) between the obtuse and acute corners of the cross-section to the thickness of the base is in the range of 4 to 6.

[0213] Referring to Figure 8b, in some configurations, the cross section of the collapsible portion includes a tail portion 490 extending from one or both corners 421, 422 of the cross section, which have acute interior angles. In a closed configuration, the tail portion 490 provides a slope to the edge of the collapsible section from the user's face to the top of the collapsible section. Thus, the slope or tail portion 490 provides a tapered or transitioning thickness at the edge of the collapsible section, improving the seal against the user's face and the collapsible portion of the conduit, allowing the mask seal to progressively press against the collapsible section from the user's face. In some configurations, the cross section has mirror symmetry in a line 450 extending through obtuse corners 423, 424, such that the same slope feature is provided, for example, at each acute corner 421, 422.

[0214] In some embodiments, the tail portion may be tapered from approximately the height of the cross-section, the thickness of the side that contacts the user's face, to a lower height, e.g., 0.5 mm or less, or tapered to a certain point. The height of the tail portion (which connects to the side of the cross-section, e.g., side 412(ii)) may be about 1 mm to 3 mm, or about 1 mm to 2 mm, or 1 mm to 1.5 mm, or about 1.2 mm. In some configurations, the height of the tail portion may be the same as the thickness of the side of the cross-section that contacts the user's face. In some configurations, the height of the tail portion may be the same as the sum of the thickness of the side of the cross-section that contacts the user's face and the thickness of the opposing side of the cross-section that comes into contact with the side that contacts the user's face when the cross-section is in a collapsed configuration (e.g., side 412(i)). In some configurations, the height of the tail portion is approximately the same as the height of the collapsed cross-section. The ratio of the height of the posterior portion to the thickness of the thinnest section of the cross-section can be approximately 1.2 to 1.9.

[0215] The length of the posterior portion can be approximately 2 mm to 6 mm, or approximately 10% to 50% of the width of the collapsible cross-section, or approximately 30% of the width of the collapsible cross-section.

[0216] In some embodiments, the portion that can be crushed may have a cross-section configured such that, in the crushed or closed configuration, the cross-section forms a tapered profile from a deeper or thicker section to a thinner section at the edge of the crushed section, as shown, for example, in Figures 8c and 8d.

[0217] Figure 8c represents a possible crushed profile of the cross-section of Figure 8a, or a cross-section similar to that of Figure 8a. Figure 8d represents a possible crushed profile of the cross-section of Figure 8b, or a cross-section similar to that of Figure 8b. In some embodiments, one or both sides of the cross-section may be tapered in thickness from one or more acute corners 421, 422 that form the inflection point of the profile toward one or more obtuse corners. Once crushed, the acute corners are located at the edges of the crushed section. When one or more sides from the acute corners toward the obtuse corners are tapered in thickness, a thicker crushed section is created in the portion between the edges of the crushed section, as shown in Figures 8C and 8D. In Figures 8c and 8d, the tapering of the thickness of the sides from the acute corners toward the obtuse corners is exaggerated to illustrate the concept of having tapered thickness to achieve a tapered crushed section. In Figure 8a, the second side 412 of the cross section, including two adjacent sides 412(i) and 412(ii) and the obtuse angle 424 of the parallelogram, is tapered in thickness from the acute corner 422 to the obtuse corner 424. The thickness of the side 412 is greatest at the obtuse corner. The resulting flattened profile needs to be tapered in thickness from the greatest thickness at or adjacent to the flattened obtuse corner 424 towards the folded acute corner at the edge of the flattened section. Similarly, in the cross section of Figure 8b, the thickness of the side 412 is tapered so that it is greater at the obtuse corner 424.

[0218] As described above, in some embodiments, as shown in Figure 8b, for example, the side 411(i) of the parallelogram section that rests on the user's face may be thicker than the other sides of the parallelogram. In the crushed configuration, the section is thinner at the thinner adjacent sides 411(ii) and 412(ii) when crushed together, and thicker at the thicker side 411(i) and the adjacent side 412(ii) when crushed together. The thinner section passing through the thinner side may provide a taper in the section from the edge 422 to the thicker section resulting from the thicker side 411(i). To provide a taper in thickness from the other edge 421 of the crushed section, preferably the section has an inclined portion 490 at an acute corner at the thicker side of the section.

[0219] Any one of the collapsible conduits in the embodiments described above may be formed from any suitable material, but in one preferred embodiment, it may be formed from an elastomer / elastic material such as silicone. The material is substantially soft and biocompatible. In some embodiments, the collapsible portion is formed such that the natural or undeformed cross section of the collapsible portion is in an open configuration. The collapsible portion is elastically deformed so that it moves from an open configuration to a collapsed configuration by an external force applied to the side of the conduit. When the force is removed, the conduit returns to its undeformed open configuration due to the elasticity of the conduit material. Furthermore, the collapsible portion is biased to move from a collapsed configuration to an open configuration by the internal pressure of the gas flow within the conduit, causing the conduit to expand into an open configuration.

[0220] The collapsible cross section described above may form only a portion of the conduit's length. The remaining portion of the conduit may have relatively thicker wall sections or different cross sections (e.g., rounded) to prevent unintended collapse of multiple portions of the conduit other than the collapsible portion. The shape and / or wall thickness may change gradually from the cross section in the non-collapsible portion to the cross section in the collapsible portion. In some embodiments, the internal cross-sectional region along the collapsible portion (e.g., the cross-sectional region of the conduit's lumen) is similar to the cross-sectional region of the intake pipe 112, avoiding large changes in a region that may generate turbulence and have high resistance to flow.

[0221] As described above, in some embodiments, the collapsible conduit or collapsible portion of the conduit may be integrally formed with and as part of the patient interface. An example of a nasal cannula 700 including a collapsible conduit portion is described here with reference to Figures 9A-9H.

[0222] The nasal cannula 700 includes a manifold portion 701 from which nasal prongs 702 extend. Side arms or members 703, 704 extend from one or each side of the manifold portion 701. A collapsible conduit portion 704 may be formed integrally with or within the side members of the cannula. In some embodiments, the side member 703 is a conduit 705 that transports the gas flow from the patient conduit 112 to the manifold 701, and the cannula, for example, includes a conduit 705 extending from one side of the manifold 701. The conduit 705 may be configured to collapse substantially along its entire length, or only a portion of its length may be configured to collapse.

[0223] In embodiments where the cannula includes a left side member 703 (left relative to the patient) and a right side member 704, one or both side members may form conduits for transporting gas to the conduits. When both side members are conduits, two patient conduits 112 are provided, with one conduit provided at the distal end of each side member. In some embodiments, as shown in Figures 9A–9H, one side member 703 may be configured as a conduit 705, and the other side member 704 may be configured to collapse but not to provide gas flow to the manifold during use. When both the conduit 705 and the side member 704 are configured to collapse, a face mask may be provided over the cannula, leaving the cannula in place on the user's face. The seal of the face mask presses against portions of the side member 704 and the conduit 705, causing them to collapse, and the seal of the face mask can form a satisfactory seal with the user's face and the cannula, as previously described with reference to Figure 3.

[0224] In some embodiments, the left and right side members 703, 704 may have the same cross-section. For example, the side members 703, 704 may have a collapsible cross-section, as described with reference to Figure 6A, whether or not they are used as conduits. When both side members have the same cross-section, this may allow them to exhibit the same collapsible behavior when the user applies uniform force to the patient's face, thus enabling similar sealing of the face mask across both cannula side members. In some embodiments, each of the side members may also be a conduit, and a plug or cap 708 may be provided at the distal end of one side member, and a conduit connector 707 may be provided at the distal end of the other side member, so the cannula is configured as a single-entry cannula for use with a single patient conduit 112. The cannula may be configured as a double-entry cannula by replacing the plug 708 with another connector to connect to a second patient conduit. Alternatively, the cannula may be configured as a single-entry cannula, in which the patient conduit is attached to the distal end of either the left or right side member, and the plug is attached to the distal end of the other side member. In other words, the cannula may be configured between a left-entry and a right-entry cannula by connecting the conduit connector and plug to the appropriate side member. In some embodiments, the conduit connector and plug and the cannula side member may be configured such that the connector 707 and plug 708 can be attached to both the left and right side members, respectively, so that the cannula can be configured as a left-entry or right-entry by swapping the connector and plug between the left and right side members.

[0225] As best illustrated in Figure 9G, in some embodiments, the cannula 700 may include a barrier or wall 706 to separate the lumen of one side member from the lumen of the other side member. In the illustrated configuration, the cannula is a single-inlet cannula. However, although the cross-sections of the two side members may be the same, only one side member used as a conduit provides the gas flow from the patient conduit 112 to the manifold 701. In some embodiments, the wall is curved to help direct the gas flow from the conduit 705 into the prong 702. This can help reduce resistance to the flow compared to a sharp corner. Furthermore, this wall may act as a rib, helping to keep the gas pathway near the prong open and preventing the cannula from kinking (e.g., if the cannula is bent around a patient with a small or narrow face). The wall separates the lumen or internal volume of one side arm 704 from the other side arm 703. One side arm that is not in fluid communication with the nasal prongs 702 may have one or more vents so that the internal volume or lumen of the side member is open to the atmosphere, allowing air to escape from inside the side member when the side member is compressed. Alternatively, the vents may be provided in the plug 708, or the plug may not be provided, leaving, for example, the distal end of the side member open. In some embodiments, the internal volume of the side member not in communication with the nasal prongs may be in fluid communication with the user's exhaled breath, for example, via a CO2 sampling tube, and the holes in the side member may be used to sample the exhaled breath.

[0226] In some embodiments, the side members 703, 704 and the manifold may be unitarily formed members from, for example, thermoplastic elastomer (TPE), silicone, etc. In some embodiments, the side members 703, 704, the manifold 701 and the nose prong 702 may be unitarily formed members. In some embodiments, the plug and / or conduit connector may be formed from a rigid material, for example, HTPE, polypropylene, ABS, polycarbonate, etc. The term rigid is used in comparison to materials used to form side arms that are substantially less rigid (more elastic or compliant with elastic deformation). Relatively rigid plugs or conduit connectors may help maintain the cross-section of the pipe in a normal open configuration. In some embodiments, the side members may be formed separately from the manifold and may be attached to or connected to the manifold. The manifold may contain a relatively rigid material so as to be rigider than the flexible or compliant side members.

[0227] In some embodiments, a headgear connector 712 is provided on each side member 703, 704. The headgear connector includes a first part 710 and a second part 711 that releasably mesh. For example, there may be a female connector part 711 and a male connector part 710 that releasably fit together. The female part 711 of the connector 712 may be formed of an elastic or flexible / compliant material, and the male part 710 may be formed of a relatively rigid material. In some embodiments, one of the connector parts is attached to the side member of the cannula, and the other of the connector part is attached to the headgear strap. In some embodiments, one of the connector parts may be formed integrally with the side member of the cannula, for example, as shown in Figures 9A-9H. In the embodiments shown in Figures 9A to 9H, the female component or half 711 of the headgear connector is integrally formed with the side members 703, 704, and the male component or half 710 of the connector is attached to the headgear strap 713. In such embodiments, the plug 708 and conduit connector 707 may have their openings airborne by the female connector half, otherwise they are in communication with the lumens of the side members. For example, the plug and conduit connectors 708, 707 each include projections 708A, 707A that fit inside the female connector half 711. The projections 708A, 707A may be received in recesses within the side arms and may be projections that help to hold the plug or connector 708, 707 within the side members against tensile forces that would pull the plug or connector away.

[0228] As shown in Figures 10A to 10D, in some embodiments, the headgear connector half 810 is integrally formed with the conduit connector 807 or plug 808 fitted / attached to the distal ends of the side members 703, 704 of the cannula 800. Integrating the headgear connector 812 and the conduit connector 807 into a single relatively rigid component can increase stability compared to configurations in which the headgear connector and conduit connector are separately connected to the relatively flexible cannula body.

[0229] Figure 10C shows a cannula with conduit connectors 807 fitted to both side members, which in some embodiments can be configured as a double-inlet cannula. In such embodiments, a wall (e.g., wall 706 in Figure 9G) may be provided between the prongs 702 within the manifold 701 so that the prongs are air-separated. The left prong or outlet 702 is provided with a gas flow through the lumen of the left side member 703, and the right prong or outlet 702 is provided with a gas flow through the lumen of the right side member 704. Alternatively, both the left and right conduits 703, 704 may be in fluid communication with both nasal outlets 702.

[0230] In some embodiments, as shown in Figure 10B, the plugs 708, 808 and / or connectors 707, 807 include raised ribs 813 that are received in corresponding recesses within a side member (not shown), allowing the plugs or connectors to be held within the side member. In the illustrated embodiment of Figure 10B, the raised ribs 813 are continuous cannula ribs or rims around the connectors and plugs that fit into annular recesses within the side member. The ribs or rims and corresponding recesses may also function as seals to prevent or minimize gas leakage from the lumen of the side member between the side member and the connector / plug.

[0231] As shown in Figures 9A-9H and 10A-10D, in some embodiments, the female connector halves 711, 811 include apertures 715, 815 that receive the lateral projections 714, 814 of the male connector halves 711, 811, and the connector halves can be fixed together. In some embodiments, the male connector halves 710, 810 have lateral projections 714, 814 on each of the two sides of the male connector halves, and the female connector halves 711, 811 have two corresponding apertures 715, 815, respectively, configured to receive the lateral projections 714, 814. Alternatively, in some embodiments, the male connector component may include an aperture for receiving the lateral projections of the female component. For example, the female component may include lateral projections extending from one or each lateral inner side surface that can engage with corresponding apertures on the sides of the male component. The male component may include an aperture extending laterally through the male component, and the lateral projection of the female component may engage with the aperture of the male component from either side. Each lateral projection 714, 814 preferably has a chamfered edge to flex the side of the female component. This allows multiple components to be easily connected when pushed together axially. In some embodiments, this or each aperture 715, 815 is a slot whose principal axis is oriented laterally with respect to the longitudinal axis of a headgear strap to be attached to a patient interface, as shown in the figure.

[0232] In the embodiments shown in Figures 9A to 9H, the female connector half is formed as a receptacle for receiving the male connector half. To disengage the two halves of the connector, one half is pulled axially away from the other half, removing the male connector half from the receptacle of the female connector half. As the connector halves 710 and 711 are pulled apart, the female half flexes elastically, so that the side of the female connector half rests on the lateral projection of the male connector half, releasing the lateral projection 714 from the aperture 715 on the female half.

[0233] In the embodiments shown in Figures 10A–10D, the female connector half 811 includes two spaced-apart tines or prongs 811A, 811B. The tines may form the sides of the female component. The tines extend from the base 811C of the female connector half so that the free end of each tine distal to the base can bend laterally relative to the base. The methods by which the connector halves 810, 811 are connected and disconnected are shown in Figures 11A–11D. As shown in Figure 11A, to connect the two halves 810, 811, the halves are pushed together axially, as indicated by the arrows in Figure 11A, so that the male component is received between the tines of the female component. The axial direction is related to the direction in which the headgear strap extends from the connector 812. Once the halves are connected, the lateral projections 814 engage with the aperture 815 in the tine, as shown in Figure 11B. The axial separation of the halves may require considerable force to allow the tines to flex and spread to rest on the projection 814. Under normal use, the axial force applied to the connector, for example from tightening the headgear, is less than the axial force required to axially separate the connector halves. However, to disengage the female part 811 from the male part 810, the female part may be rotated around an axis lateral to the connector parts 810, 811 or axially, for example, lateral to the headgear strap extending from the connector 812, as shown by the arrow in Figure 11C. The aperture 815 is shaped such that relative rotation between the male and female parts releases the projection from the aperture and flexes the tines over the projection. For example, if the aperture is a slot and the corresponding projection is elongated to fit into the slot, relative rotation between the parts spreads the tines when the projection interferes with the area of ​​the tines around the slot. In Figures 11C and 11D, the female part rotates, so the male and female parts are only partially engaged, the tines flex outward, ride on the lateral projections, and disengage the female part from the male part. The force required to rotate the female part relative to the male part is reduced compared to the force required to separate the multiple parts axially.This is because the projection 814 and the corresponding aperture 815 are elongated, with their main shafts aligned perpendicular to the length of the head strap. With the main shafts of the aperture and projection perpendicular to the strap, the area over which axial forces can act is increased, resulting in a more secure attachment. Therefore, the tine configuration of the female connector achieves a connector that is secure in the axial direction where the forces of the headgear strap are aligned, but allows for a relatively easy or reduced disconnection force through relative rotation of the male component 810 and the female component 811. Since relative rotation of the male and female components does not occur in normal operation except when rotated by a person wishing to disconnect the headgear from the interface, the described arrangement prevents or reduces accidental disconnection. Therefore, this configuration allows for easy release of the cannula from the headgear, which can help reduce the difficulty of removing the cannula from the user's face. Furthermore, the female half 811 can be disengaged from the male half by the user with one hand simply by twisting the female half against the male half. In another embodiment, the apertures and projections may be circular, and other features such as complementary bevels or cam surfaces are arranged on the male and female parts so that the relative rotation of the multiple parts widens the tines and disengages each projection from the corresponding aperture.

[0234] To create an effective seal between the mask 300, cannula 700, 800 and the user's face, it may be desirable to have a cannula side member or conduit section extending across the mask seal that is positioned on the softer parts of the user's face. Correspondingly, it may be desirable to avoid the harder parts of the patient's face. This may increase the chances of covering the upper side of the cannula and achieving an effective seal of the mask seal with the user's face, by allowing the user's face to deform around the cannula. Positioning the cannula on the softer parts of the user's face may also help to increase patient comfort by avoiding pressure on bony / hard parts of the user's face, such as the cheekbones. In general, it may be more comfortable to have other cannula components that lie on the softer parts of the face, such as a head strap.

[0235] Figure 12A shows the relatively soft area S of the user's face compared to the relatively hard area H. Figure 12B further highlights the soft area S of the user's face, which can be described as the area enclosed by a line extending from the bottom of the user's nose to the central area of ​​the user's ear, and a line extending almost horizontally from the user's upper lip (bottom of the philtrum) in the user's upright position, for example, above the user's mandible. As shown in Figure 12C, preferably the cannula is positioned in the softer area of ​​the user's face.

[0236] In some embodiments, to position the cannula side member in a softer area of ​​the user's face, the cannula is positioned such that, when the cannula is viewed from the side, the headgear strap extends from the side member at a certain angle to the side member. For example, the angle may be 10–30 degrees, or 15–25 degrees, or about 20 degrees. In Figures 9E and 10D, the headgear strap 713 is shown extending from the side member of the cannula at an angle of about 20 degrees. To position the headgear strap at a desired angle, the headgear connector is preferably oriented at the desired angle. For example, in Figure 9E, the female connector half 711 is formed integrally with the side member at a certain angle to the side member to orient the strap correctly with respect to the cannula. In Figure 10D, the male connector half 810 is formed integrally with the conduit connector 807 at a certain angle to the side member with the conduit connector attached to the side member to orient the strap correctly with respect to the cannula 800. In the embodiments shown in Figures 9A–9H and 10A–10D, the strap angle is positioned so that the cannula is nearly horizontal across the user's face (when the user is upright), and the headgear strap extends above the user's ears. Because the head strap is oriented above the patient's ears, the physician can apply a jaw thrust to the patient without obstruction. As shown in Figure 10D, the conduit connector 807 is positioned so that the conduit 112 extends from the cannula in conjunction with the side member 703. Also, as shown in Figure 10C, in the plan view, the angles of the conduit connector 807 and the headgear connector 812 relative to the side members 703, 704 are the same (or similar) so that the conduit extends in conjunction with the headgear strap in the plan view. The arrangement of the conduit connector relative to the side members and headgear connector ensures that the inspiratory tube is parallel to the patient's face when the patient is lying supine. This configuration controls the weight of the inspiratory tube and reduces the chance of twisting in the parts of the cannula that can be compressed by the weight of the inspiratory tube.

[0237] The cannulas 700 and 800 described above are also shown in Figures 13A and 13B in several indicated geometric shapes (in Figure 13B, the conduit connector 707 and plug 708 are omitted). In the drawings, including Figures 13A and 13B, the cannulas are shown in an unbent or bent configuration (e.g., neutral or relaxed). In some embodiments, an obtuse angle is formed between the side members in the plan view. In some embodiments, the angle between the side members is in the range of 100–130 degrees, or about 100–120 degrees, or about 100–110 degrees, or about 105 degrees. In the illustrated embodiment, the angle is 106 degrees. Such an angle allows the cannula to contour around the user's face without the manifold or side members twisting. In particular, this angle may be equal to or greater than the angle required to match the cannula to a typical adult face. In this case, when the head strap is tightened, the cannula may be on the face, or slightly bent or deformed inward to conform to the user's face. Bending the cannula inward (i.e., around the user's face) causes far less twisting of the flexible cannula than bending the cannula outward (i.e., away from the user's face, as is the case when smaller angles are used). Larger angles are also particularly useful for accommodating patients undergoing this treatment who have larger head circumferences, likely due to a higher BMI.

[0238] In some embodiments, in a plan view of the cannula, the distance between the distal ends of the side arms and / or between the pair of headgear connectors 712, 812 (distance X in Figure 13B) is approximately 100 mm to 150 mm, or approximately 110 mm to 140 mm, or approximately 110 mm to 130 mm, or approximately 120 mm. This distance is wide enough for a non-invasive ventilation mask to cover the cannula with the edges of the seal within X (non-invasive ventilation masks generally have a width of approximately 100 mm). In some embodiments, the relatively rigid connector 807 is positioned as close as possible to the prong 702, while still having a portion that can be crushed long enough for the mask to fit (dimension X). Such a configuration may enhance comfort because the connector 807 is as close as possible to the prongs (i.e., the center of the user's face) and the connector is away from the patient's temporal region; therefore, in a patient lying on their side, the connector may not be directly below the patient's face between the patient's head and the pillow.

[0239] In some embodiments, an obtuse angle may be formed between the headgear connector and the side arm in the plan view. For example, as shown in Figure 13A, the cannula 800 includes an angle of about 150 degrees between the headgear connector 812 and the side members 704, 703. In some embodiments, this angle may be in the range of 130 to 170 degrees, or 140 to 160 degrees, or 145 to 155 degrees.

[0240] The geometric shape and arrangement described above can offer several advantages. Having a horizontal cannula that crosses the face below the nose means that the collapsible portion of the cannula intersects the face mask seal at a perpendicular angle, thus narrowing the area over which the seal acts and reducing the force required to collapse the collapsible portion. Furthermore, the horizontal section encourages the cannula to lie on the softer section of the face, as the softer area immediately next to the nose is relatively narrow. The arrangement described may reduce the risk of the cannula and / or conduit 112 being angled upward toward the user's ears and lying on the user's hard cheekbones. The obtuse angle between the inspiratory tube and the cannula conduit described above eliminates sharp (abrupt) corners in the gas flow path that can create turbulence and increase resistance to flow. The arrangement also positions the conduit connector 807 closer to the user's face, reducing the lever effect from the weight of the conduit 112 that could cause twisting of the cannula. In some embodiments, the conduit connector 807 may be angled inward toward the user's face to position the conduit closer to the face. For example, in Figure 10C, the conduit connector is positioned substantially parallel to the user's sagittal plane, but in some embodiments, the connector 807 may be angled inward by 15 degrees relative to the sagittal plane. As described above, the head strap connector 810 and the conduit connector 807 are substantially in the same plane (vertically upward) to reduce the levering effect from the weight of the conduit, which could cause twisting of the cannula. In some embodiments, the headgear connector 810 is centered across the inspiratory tube connector 807 and can also reduce the levering effect from the weight of the conduit, which could cause twisting.

[0241] Figures 14A–14C show alternative headgear. In Figure 14A, the headgear includes a strap 713. In Figure 14B, the headgear includes a pair of elastic loops 720, each loop configured to wrap around the user's ears. In Figure 14C, the headgear includes a pair of arms 730, whose function is similar to that of eyeglass arms. The arms 730 preferably extend downward past the back of the ears to ensure a secure hold of the cannula to the user's face. All of the headgear described above may have the same connector and are therefore interchangeable when desired by the user or patient. Headgear 720, 730 that do not wrap around the back of the patient's head may be particularly convenient when the clinician does not want to move the patient's head to apply or remove the cannula, or to prevent the patient's hairnet from coming off the head strap or the patient's hair from becoming entangled in the head strap. All headgear may be adjustable to different patient sizes (for example, the elastic loop 720 can be pulled and tightened through the connector 812).

[0242] In some embodiments, the cannulas 700, 800 may be configured to be used without collapsing by providing a shield or support member (e.g., a frame) that fits and / or covers one side member, or both side members and the manifold. For example, as shown in Figure 15, a removable shield 801 that fits the side members and the manifold may be provided. The shield 801 may be formed from a relatively rigid material to support the cannula against collapse, for example, collapse resulting from an external force applied to the cannula. The shield may be held in place of the cannula by including one or more pairs (e.g., two pairs) of jaws 802 configured to grip around a portion of the cannula side arm or manifold or plug or conduit connector. In the illustrated embodiment, the shield includes a pair of jaws at each end of the shield, with each pair of jaws configured to grip around a corresponding portion of the side member. The cannula may include a cannula body formed of a relatively flexible material, which, as described above, includes a manifold and at least one nasal prong or outlet, and side members extending from each side of the manifold. The shield or frame is formed of a relatively rigid material (compared to the cannula body material). The shield is attached to the cannula body and supports the cannula body against crushing of the side arms.

[0243] In the cannula described above, in a preferred embodiment, the cannula is "slim," reducing the size of the interface on the patient's face. Additionally, the relatively rigid headgear connectors 712, 812 are slim, reducing the bulk between the patient and the pillow supporting the patient's head when the patient is in a lateral position, thereby enhancing patient comfort.

[0244] Figures 16A - 16E illustrate a further cannula embodiment 900 that includes a cannula body 935 formed of a relatively flexible material and a frame 950 formed of a relatively rigid material. The cannula body 935 includes, as described above, a manifold 901 and at least one nasal prong or outlet 902, and side arms or members 903, 904 extending from each side of the manifold. The left side member 903 extends from the left side of the manifold, and the right side member 904 extends from the right side of the manifold. Each side member includes a lumen to provide a conduit for the flow of gas from the inlet of the cannula to the manifold. In some embodiments, the conduit of each side arm includes a collapsible portion as described in the previous embodiments. The frame 950 is attached to the cannula body 935 and can prevent collapse of the cannula body and the conduits. In some embodiments, the frame 950 supports the cannula body 935, but allows the body 935 to collapse when a force is applied to the front surface of the frame 950, thereby occluding the lumen. The frame 950 can be adapted to elastically deform, so that a force applied to the front side of the cannula frame 950 bends the frame and collapses the side members 903, 904 and the lumens of the cannula body. Once the force is removed from the frame, the frame 950 and the cannula body 935 return to their non - collapsed configuration. Alternatively, in some embodiments, the frame 950 can function as a strut or support for the cannula body 935 and can prevent collapse of the cannula body. The frame can be used with the body in procedures where collapse of the cannula is undesirable. The frame can be removably attachable to the body.

[0245] The cannula body 935 may include a gas inlet portion 924 into the lumen of the cannula body. The gas inlet portion 924 may be located at or near the ends of the side arms 903, 904. As shown in the figures, in some embodiments, the cannula includes a gas inlet portion 924 on each side arm 903, 904. The frame 950 may include an inspiratory tube connector 925 for attaching the inspiratory tube 112 to the cannula. In some embodiments, the inspiratory tube connector 925 receives the gas inlet portion 924 of the cannula body. When gas is supplied to the cannula 900, the pressure of the gas forces the gas inlet portion 924 into contact with the inside of the inspiratory tube connector 925 (for example, by inflating the inlet portion). The outer surface of the gas inlet portion 924 contacts the inner surface of the inspiratory tube connector 925 to create a seal, substantially preventing gas leakage.

[0246] The cannula body 935 and the frame 950 are movably mounted together. For example, in some embodiments, the frame 950 may be pivotably (rotatably) mounted to the cannula body 935 so that the frame can rotate relative to the cannula body. In the illustrated embodiment, the cannula body may include a post 952, and the frame may include an aperture 951 or recess for receiving the post, and the frame 950 rotates around the post 952 in the aperture or recess 951. The post may be formed of a relatively rigid material compared to the material that generally forms the cannula body. The post may be overmolded into a softer or more elastic material than the cannula body. In an alternative configuration, the cannula body 935 may include an aperture or recess in the frame 950 for receiving the post. In some embodiments, the cannula body includes a gas inlet portion 924 on each side arm 903, 904 (for example, toward or to the end of each side arm). The frame includes an inspiratory tube connector and a blank hollow projection or recess 926 (e.g., a tubular projection of the blank). The inspiratory tube connector 925 is fitted to receive the gas inlet portion 924 of the cannula body 935. When gas is supplied to the cannula 900, the pressure of the gas within the cannula forces the gas inlet portion 924 to contact the inside of the tube connector 925 (e.g., by expanding the inlet portion). The outer surface of the gas inlet portion contacts the inner surface of the tube connector to create a seal, substantially preventing gas leakage between the tube connector 925 and the cannula body 935. Similarly, the hollow projection 926 is fitted to receive the gas inlet portion 924 of the cannula body 935. When gas is supplied to the cannula, the pressure of the gas within the cannula forces the gas inlet portion 924 to contact the inside of the hollow projection 926 (e.g., by expanding the inlet portion). The outer surface of the gas inlet portion 924 contacts the inner surface of the hollow projection 926 to create a seal, substantially preventing gas leakage. By rotating the cannula body 935 relative to the frame 950, the cannula 900 is selectively configured between a left conduit inlet and a right conduit inlet. Figure 16D shows the frame partially rotated relative to the cannula body between the left and right configurations.Alternatively or in addition, the frame 950 is removably attached to the body 935 and can be attached to the body in two orientations, the first orientation providing a left inlet and the second orientation providing a right inlet. The cannula is configured as a left inlet cannula when the inlet portion 924 on the left side member 903 of the cannula body is received by the intake tube connector 925 of the frame and the inlet portion 924 on the right side member 904 of the cannula body is received by the hollow protrusion 926 of the frame 950. The cannula is configured as a right inlet cannula when the inlet portion 924 on the right side member 904 of the cannula body is received by the intake tube connector 925 of the frame and the inlet portion 924 on the left side member 903 of the cannula body is received by the hollow protrusion 926 of the frame 950 (as shown in FIG. 16A).

[0247] In an alternative embodiment, the cannula body may include a pair of gas inlet portions 924 respectively disposed at or towards the distal ends of each side arm, and the frame includes a pair of intake tube connectors 925 disposed at opposite ends or on opposite sides of the frame, and the cannula is configured for use as a dual inlet cannula to receive one of the pair of gas inlets 924 corresponding thereto. A pair of intake tubes may be attached to the pair of tube connectors 925 to supply gas to the cannula.

[0248] As shown in FIG. 16E, the frame 950 may include a concave rear surface 953 (the side facing towards the user's face to receive the cannula body 935 during use. The front side 906 of the cannula body (facing outward when viewed from the user's face during use) is complementarily convex and can fit within the frame.

[0249] As shown in the examples in Figures 16A-16E, in some embodiments the patient interface includes a headgear, which includes a pair of earplugs 941. Each earplug 941 is fitted to the user's ear to hold the patient interface 900 in place on the user's face. The headgear may include a pair of arms 940, each earplug being provided on one of the arms. The length of one or both arms may be adjustable. For example, one or both arms may include a telescopic configuration. One or both arms may include two or more parts arranged in a nested telescopic configuration. In the illustrated embodiment, each arm includes a first part 942 that is slidably received into a second part 943, and the relative movement between the first and second parts achieves a variable length. This allows the interface to be easily adapted to different patient sizes. The arms may include a telescopic configuration with a ratchet assembly. The ratchet assembly may include a locking mechanism adapted to lock the telescopic arms in one or more predetermined positions. For example, the locking mechanism includes a movable latch that is movably fixed to one part 942, 943 of the arm, and a series of grooves or apertures that can be movably engaged with another part 943, 942 of the arm. As shown in the illustration, in some embodiments the patient interface is a nasal cannula. One of the first and second parts 942, 943 of each arm 940 may be formed integrally with the side of the cannula. In the illustrated embodiment, the first part 942 of each arm 940 is formed integrally with a frame 950 that is attached to the cannula body 935. One of the first and second parts 942, 943 of the arm 940 may be rigider than the other of the first and second parts of the arm. For example, the first part 942 received in the second part 943 may be rigider than the second part 943. Preferably, the earplug is formed of a soft material so as to be comfortable in the user's ear and not slip in it. For example, the earplug may be made of silicone or other suitable plastic or foam material.In an alternative embodiment, the arm 940 includes first and second parts 942, 943 which may not have an earplug 941 and are received above and rest on the upper side of the user's ear.

[0250] The cannula body 935 and frame 950 can be curved overall to conform to the shape of a human face. A human face is substantially curved as it moves from the nose to the cheeks. The curved shape of the cannula body and frame follows the overall shape of a human face. The curved shape allows for a thinner profile on the face and a better fit to the patient's face. The cannulas in Figures 16A–16E may include the geometric shape features described above with reference to Figures 13A and 13B. The cannula body and frame have a curved shape. Both the cannula body and frame have a convexly curved front surface (954 and 906 in Figure 16C). The convex curve of the front surface of the cannula body and frame is a curve from the top to the bottom of the body and frame, as shown in the cross-section in Figure 16E (for example, relative to the person wearing the cannula).

[0251] The cannulas in Figures 16A–16E are configured to be placed or positioned horizontally across the patient's face (for example, for a patient in an upright position). Such a placement configuration ensures that when a face mask is applied over the cannula, the seal of the face mask is approximately perpendicular to the collapsible portion of the cannula, within a range of mask sizes, including larger masks. The placement configurations disclosed are also useful in situations where the clinician does not want to lift the patient's head to apply or remove the cannula. The configurations in Figures 16A–16E can be particularly easy to apply when the patient is lying down, as they do not require attachment behind the patient's ears; therefore, the cannula can be applied directly to the patient's face by a clinician standing right next to the patient.

[0252] Figure 17 shows a further embodiment of cannula 1000 having a left gas inlet 1024 and a right gas inlet 1024. The cannula includes a manifold 1001, a pair of nasal prongs 1002 or outlets extending from the manifold, and side members 1003, 1004 extending from each side of the manifold 1001. In this specification and in the claims, the term “manifold” is intended to mean broadly a member comprising at least two separate lumens, or a member comprising a single lumen with at least two inlets or at least two outlets, unless the context suggests otherwise. In the illustrated embodiment, the manifold 1001 comprises two separate manifold lumens 1016, 1017, each manifold lumen being in fluid communication with its respective prong or outlet 1002 so that the prong or outlet is aerially isolated. Side members 1003 and 1004 each contain lumens and provide a conduit for gas flow from the inlet 1024 to the corresponding manifold lumens 1016, 1017 and associated nasal prongs or outlet 1002. The gas flow is supplied to the cannula via the two inlets 1024. In some embodiments, the inlets 1024 may be formed from a rigid material that can improve connection with the gas supply tube or conduit. The rigid element may help achieve a sealed connection with the connector of the gas supply conduit. The rigid connector may be molded, overmolded, or co-mouled onto the cannula body.

[0253] Each side member 1003, 1004 is configured to be collapsible and can be collapsible independently of the other. In normal use, if one member 1003, 1004 is collapsed or its lumen is inadvertently blocked, the other side member 1003, 1004 continues to provide gas flow to the user through the associated nasal prong or outlet 1002. In some embodiments, as illustrated, the cannula 1000 is formed as a single, integrally formed body, preferably of a flexible material. In some embodiments, in addition to a single, integrally formed cannula body, the cannula may include a rigid frame or shield, such as the frame 801 described above with reference to the embodiment in Figure 15, or the frame 950 described with reference to Figures 16A-16E. The interface supplying flow from two sides allows for a smaller size of the inhalation conduit 112 than a single supply conduit, but still allows for the supply of the same flow rate. This is advantageous because it reduces the size of the interface on the face and allows clinicians to access more of the patient's face and airway.

[0254] In an alternative embodiment, the manifold includes a gas path that allows fluid communication between the lumens of the left and right side members 1003 and 1004. The gas path within the manifold also allows fluid or gas communication between the lumen of the left side member 1003 and the right prong 1002 and the lumen of the right side member 1004 and the left prong 1002. In such an alternative embodiment, if one of the prongs becomes unexpectedly blocked, the gas may be received by both prongs located at either the left or right inlet 1024. Such an arrangement configuration may be advantageous in order to ensure that sufficient flow is provided to the apnea patient, matching the inspiratory demand, so that sufficient O2 is delivered and CO2 flushing occurs.

[0255] In some embodiments, the cannula 1000 may be formed in a curved configuration to match the features of the user's face and may include geometric features as described above with reference to Figures 13A and 13B. The cannula 1000 may include a suitable headgear connector, as described, for example, with reference to Figures 11A-11D. The headgear connector may be attached to the cannula at some point on the side member or connected to the entrance section 1024. Force from the headgear may pull the cannula toward the user's face, causing the flexible body of the cannula to deform to conform to the patient's face. When the cannula is conformed to the patient's face, it achieves a low profile on the patient's face.

[0256] Figures 18A–18D provide further examples of nasal cannulas 1100 including a collapsible conduit portion. The cannula includes a side member 1103 that forms or includes a collapsible conduit portion. The nasal cannula 1100 includes a manifold portion 1101 from which nasal prongs 1102 extend. The side arm or member 1103 extends from one side of the manifold portion 1101. In some embodiments, the side member 1103 extends from each side of the manifold portion, as described in previous embodiments. The collapsible conduit portion 1103 may be formed within or integrally with the side member of the cannula. In some embodiments, the side member 1103 is a conduit for transporting gas flow from a patient conduit (e.g., conduit 112 in Figure 1) to the manifold 1101, and the cannula, for example, includes a conduit 1103 extending from at least one side of the manifold 1101. The conduit 1103 may be configured to collapse substantially along its entire length, or to collapse only a portion of its length. In the illustrated embodiment, the cannula 1100 includes a conduit 1103 having a collapsible portion 1103a and a non-collapsible portion 1103b. The collapsible portion 1103a may be formed from a relatively soft, flexible material such as silicone. The non-collapsible portion 1103b may be formed from a relatively hard or rigid material compared to the material of the collapsible portion. In some embodiments, the collapsible portion 1103a is located between the manifold 1101 and the non-collapsible portion 1103b of the conduit. In some embodiments, the non-collapsible portion 1103b includes an inlet 1124 to receive the flow of gas into the cannula 1100.

[0257] In some embodiments, the cannula 1100 further includes a mechanism for crushing the collapsible portion of the conduit. In some embodiments, the mechanism is a rigid component (rigid relative to the collapsible conduit portion) attached to the outside of the cannula and moves from a first configuration in which the collapsible portion is in an open configuration to a second configuration in which the component presses against the outside of the collapsible portion, thereby clamping or flattening the collapsible portion to form a closed configuration. In the illustrated embodiment, the component is a lever 1150, which is actuated by an externally applied force, for example, a face mask 304 is applied to the user's face over the top of the cannula 1100, and pressing the lever 1150 is brought about by the force provided by the seal 304 of the face mask. In some embodiments, the lever 1150 is pivotally supported by or attached to the non-collapsible portion 1103b of the conduit 1103. During use, the user rotates the lever 1150 by pressing the lever (for example, by pressing the face mask seal against the lever), pressing the lever against the collapsible portion 1103a, thereby collapsing the collapsible portion 1103a and closing or partially closing the lumen of the collapsible portion 1103a. The lever 1150 is swivelable between a first configuration, as shown in Figure 18C, where the collapsible portion is open, and a second configuration, as shown in Figure 18D, where the collapsible portion is closed. In the second configuration, the lever presses against the outside of the collapsible portion 1103a of the conduit, thereby clamping or flattening the conduit. In some embodiments, the lever may be swivel-mounted to the manifold portion 1150, provided that the manifold has sufficient rigidity to support the lever swivel-wise and allow it to swivel between the first and second configurations. When the force is removed from the lever 1150, the gas flows through the collapsible portion and the lever returns to the first configuration. The lever may include projections such as a rim 1151 that contact and clamp the conduit in a closed configuration. The projection or rim 1151 is preferably wider than the portion that can be crushed, so the rim is applied across the entire width of the conduit.

[0258] In some embodiments, the lever 1150 includes a first arm 1152 extending from a first side of the pivot 1153 and a second arm 1154 extending from an opposing second side of the pivot 1153. In the first configuration (Figure 18C), the lever 1150 pivots around the pivot 1153 so that the first arm does not clamp or flatten the conduit, and the second arm 1154 covers, closes, or conceals the ventilation aperture 1120 in the conduit 1103. In the second configuration (Figure 18D), the lever 1150 pivots so that the first arm 1152 clamps or flattens the conduit 1103, and the second arm 1154 lifts away from the ventilation aperture 1120, allowing gas in the conduit upstream of the collapsible portion 1103a to vent to the atmosphere. In such embodiments, the lever 1150 operates like a seesaw, in a first configuration, to close the collapsible portion 1103a and allow air to pass through the upstream conduit, and in a second configuration, to open the collapsible portion 1103a and close the ventilation aperture 1120.

[0259] In some embodiments, the cannula 1100 is formed in a curved configuration to conform to the features of the user's face. Although the cannula 1100 is shown comprising a single side member 1103, in some embodiments it may include a left side member and a right side member as described in a previous embodiment, and may include geometric features as described above with reference to Figures 13A and 13B. Furthermore, the cannula 1100 may include a suitable headgear connector, as described, for example, with reference to Figures 11A-11D. The headgear connector may be attached to the cannula at some point on the side member. The force from the headgear pulls the cannula toward the user's face, causing the flexible body of the cannula to deform to conform to the patient's face. When the cannula is conformed to the patient's face, it achieves a low profile on the patient's face.

[0260] In some embodiments, the conduit, for example, the intake conduit 112, may include a collapsible portion and a lever 1150 as described above.

[0261] In some embodiments, the patient interface or conduit may include a collapsible portion and a rigid shield or member attached to the outside of the collapsible portion. The member is rigid relative to the conduit portion and is adapted to distribute any external force applied to the member across a predetermined collapsible area of ​​the collapsible portion. The rigid member helps ensure that the collapsible portion is properly and securely clamped, thereby substantially closing the conduit and avoiding the formation of wrinkles or folds in the conduit, which could otherwise provide a leakage path through the collapsed portion of the conduit.

[0262] Aspects of the present invention have been described above with respect to nasal cannulas. However, aspects of the present invention may be applied to other interfaces, such as oral interfaces. An exemplary oral interface 1200 is shown in Figure 19, and its general features are described in U.S. Patent No. 9,155,855. Interface 1200 includes a vestibular shield 1221, an outer flap 1225, and a connector 1235 connecting the outer flap to the vestibular shield. During use, the vestibular shield 1221 is received in the user's mouth and rests within the user's lips, and the outer flap 1225 rests outside the user's mouth around the outside of the user's lips. Sealing is formed by the pressure caused by the outer flap 1225 against the outside of the user's lips and the opposing force of the vestibular shield 1221 against the inside of the user's lips. Interface 1200 provides a flow of gas to the user through the connector and through outlets 1223, 1224 from the connector. Outlets 1223, 1224 can be received by outlets 1232, 1233 of shield 1221. In the illustrated embodiment, manifold 1201 is provided to be attached to the connector. Side members or conduits containing lumens extend from each side of the manifold, left side member 1203 and right side member 1204 (towards the user). An intake conduit (e.g., conduit 112) is connected to at least one of the side members 1203, 1204 during use to provide a flow of gas through one or more side members and manifold 1201, through connector inlet 1234 to connector 1235, and through connector outlets 1223, 1224 to the user's airway. In some embodiments, the interface may include a body comprising manifold 1201, an outlet 1202 from the manifold (such as one connected to connector inlet 1234), and side members 1203, 1204. In some embodiments, the body may also be formed integrally with the outer flap 1225, or the connector 1235, or both.In some embodiments, the outer flap 1225, connector 1235, and shield 1221 may be integrally formed and together integrally formed with the manifold 1201 and side members 1203, 1204. In some embodiments, the oral interface may be without a manifold and may include an L-shaped connector for configuring the interface as an embodiment of a single inspiratory conduit. The side members 1203, 1204 each include a collapsible conduit portion, as described above with reference to the cannula embodiment. In some embodiments, the side members 1203, 1204 enclose and / or are adjacent to the outer flap 1225. In some embodiments, the side members or conduit may be positioned between the patient's facial side of the outer flap, which is integrally formed with and / or contacts the user's face or lips, and the outer side (opposing side) of the outer flap. The oral interface 1200 may further include one or more features of the above-described embodiments of the cannula with respect to a collapsible conduit portion, and / or configurability as, for example, a dual or single inlet interface.

[0263] Where, in the above description, any component known to be a complete set or equivalent thereto is referred to, those complete sets are invoked herein as if they were described separately.

[0264] While this disclosure describes several embodiments, other embodiments that will be obvious to those skilled in the art are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, various components can be repositioned as desired. Furthermore, not all features, embodiments, and advantages are necessarily required to implement this disclosure. Accordingly, the scope of this disclosure is defined solely by the following claims.

Claims

1. It is a nasal cannula. The manifold includes: at least one nasal prong extending from the manifold so as to be received by the user's nostril; side members extending from each side of the manifold; and a wall near the inlet side of the nasal prong and on the inlet side of the nasal prong or outlet, which separates the lumen of one side member from the other side member so that only one of the side members functions as a conduit providing gas flow from the inlet of the nasal cannula to the manifold. In the plan view, when the nasal cannula is in an uncurved configuration, an obtuse angle is included between the side members. The side member and the manifold are integrally formed unitary members. A nasal cannula in which one side member that performs the function of a conduit includes a collapsible portion, the collapsible portion being integrally formed within or together with the side member of the nasal cannula, the cross-section of the collapsible portion including a first side and a second side, the first side and the second side being joined by first and second bending points.

2. The nasal cannula according to claim 1, wherein the obtuse angle is in the range of 100 to 130 degrees, or about 100 to 120 degrees, or about 100 to 110 degrees, or about 105 to 106 degrees.

3. The nasal cannula according to claim 1 or 2, wherein the side members are substantially straight in an uncurved configuration, and the manifold is curved to provide the obtuse angle between the side members.

4. The nasal cannula according to any one of claims 1 to 3, wherein the nasal cannula includes a pair of headgear connector components, each component being connected to a corresponding headgear connector component to be fitted for attaching a headgear to the nasal cannula, and the distance between the distal ends of the side members or between the pair of headgear connector components is about 100 mm to 150 mm, or about 110 mm to 140 mm, or about 110 mm to 130 mm, or about 120 mm.

5. The nasal cannula according to any one of claims 1 to 4, wherein the nasal cannula includes a pair of headgear connector components, each component being connected to a corresponding headgear connector component to be fitted for attaching a headgear to the nasal cannula, and each headgear connector component is positioned at a certain angle with respect to the side member in a plan view of the nasal cannula, the angle being in the range of 130 to 170 degrees, or 140 to 160 degrees, or 145 to 155 degrees.

6. The nasal cannula according to any one of claims 1 to 5, comprising a pair of headgear connector components, each component being connected to a corresponding headgear connector component to be fitted for attaching a headgear to the nasal cannula, and each headgear connector component being positioned at a certain angle to the side member in a side view of the nasal cannula, so that during use the nasal cannula is positioned horizontally to the user's face and the headgear extends above the user's ears.

7. The nasal cannula according to claim 6, wherein the angle is 10 to 30 degrees, or 15 to 25 degrees, or about 20 degrees.

8. The nasal cannula according to any one of claims 1 to 7, wherein the side member is a conduit for transporting the gas flow from the patient conduit to the manifold.

9. The nasal cannula according to any one of claims 1 to 8, wherein one or both side members form a conduit for transporting gas flow.

10. The first side of the cross-section of the collapsible portion is for positioning in contact with the user's face, The second side of the cross-section of the portion that can be crushed faces the first side and is directed outward when viewed from the user's face. The nasal cannula according to any one of claims 1 to 9, wherein the thickness of the first and second bending points is thinner than the thickness of the remaining portion of the cross-section of the collapsible portion.

11. A nasal cannula according to any one of claims 8 to 10, comprising a plug, the plug being fitted to fit the end of one or both side members.

12. The nasal cannula according to claim 11, wherein the side member is formed from a relatively soft or compliant material, and the plug is formed from a relatively hard or rigid material.

13. A nasal cannula according to any one of claims 8 to 12, comprising a conduit connector, the conduit connector being fitted to the other end of one or both side members.

14. The nasal cannula according to claim 13, wherein the side member is formed from a relatively soft or compliant material, and the conduit connector is formed from a relatively hard or rigid material.

15. The nasal cannula according to any one of claims 1 to 14, wherein the wall is curved to help direct the flow of gas from the conduit into the at least one nasal prong.

16. The nasal cannula according to any one of claims 1 to 15, wherein the wall serves as a rib that helps keep the gas pathway near the at least one nasal prong open and prevents twisting of the nasal cannula.

17. The nasal cannula according to any one of claims 1 to 16, wherein the nasal cannula is a single-entry nasal cannula.

18. The nasal cannula according to any one of claims 1 to 17, wherein the side member, the manifold, and the nasal prong are integrally formed unitary members.

19. The nasal cannula according to any one of claims 1 to 18, wherein the nasal cannula comprises a cannula body formed of a relatively flexible material, the cannula body comprising the manifold and at least one nasal prong and side members extending from each side of the manifold.

20. The nasal cannula according to any one of claims 1 to 19, wherein the nasal cannula is an open-type patient interface.

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