Patient interface and its aspects

Abstract

Patient interface, which includes the following: a frame (303) and a seal (301), wherein the seal (301) has a patient-facing side with at least one patient opening and a frame-facing side with at least one frame-facing opening, wherein the seal engages in the frame (303) at a lip defined by the circumference of the opening pointing to the frame (303), wherein the frame (303) has a first component (1070) and a second component, wherein the first component (1070) has a first section of a channel (1096) for engaging in the lip of the seal (301), wherein the second component has a second section of the channel (1096) for engaging in the lip of the seal (301), wherein the seal (301) can be engaged and disengaged from the channel, while the first and second components are connected to form the channel, wherein the frame is formed using rigid materials.

Description

AREA OF INVENTION

[0001] The present invention relates to patient interfaces for the delivery of respiratory gases to a patient and aspects of patient interfaces. SUMMARY OF THE STATE OF THE TECHNOLOGY

[0002] The present invention relates to patient interfaces for delivering respiratory gases to a patient. The invention is described in particular with reference to patient interfaces for administering PAP therapy to a patient, for example, to patients with obstructive sleep apnea (OSA). However, the patient interface could also be used for other treatments. Furthermore, aspects of the patient interface could be combined with aspects of other patient interfaces for use in PAP therapy or for use with other therapies.

[0003] Desirable features of patient interfaces for PAP therapy include light weight, comfort, intuitive application, good sealing and stability, and safety in use.

[0004] When this patent specification refers to patent specifications, other external documents, or other sources of information, this is generally done to provide context for discussing the features of the invention. Unless specifically stated otherwise, references to such external documents are not to be construed as an acknowledgment that such documents or sources of information are considered prior art in any jurisdiction or form part of the generally accepted state of the art.

[0005] Further information helpful for understanding the present invention can be found in the following documents: US 2005 / 0 028 822 A1 relates to an integrally shaped ventilation interface that has a hollow, bellows-like structure and two nasal projections extending from an upper surface of the bellows.

[0006] US 2006 / 0054169A1 relates to a breathing nozzle comprising a hollow body with a front part and a rear part, at least one outlet made of a resilient diaphragm, and two inflatable nasal tubes.

[0007] WO 2009 / 052 560 A1 concerns a patient interface for supplying air at a positive pressure to the entrance of a patient's airway for the treatment of breathing abnormalities during sleep.

[0008] WO 2009 / 139 647 A1 concerns an interface that has an inflatable shell with a flexible wall structure.

[0009] WO 2010 / 139 014 A1 concerns a patient interface for supplying a respiratory gas to a patient.

[0010] EP 2 022 528 A2 concerns a patient-specific device for administering a respiratory gas to a patient.

[0011] DE 11 2010 001 994 T5 concerns a patient interface with a nose seal and a face contact side.

[0012] US 2006 / 0249159A1 relates to a patient interface device comprising a pillow arrangement with a pillow-in-pillow configuration and a system for delivering a gas flow to a patient using such an interface. SUMMARY OF THE INVENTION

[0013] One object of the present invention is to provide a patient interface or aspects of a patient interface that offer the public at least a useful choice.

[0014] In one aspect, the present invention roughly consists of: a patient interface comprising a nasal seal with a face-contact side, wherein the nasal seal is formed from a soft, flexible material, and a central section extending over the base of the nose, and a side section extending from each end of the central section, each side section extending over the side of the nose, wherein a face-contact side of the seal is flexible so that it can conform under internal pressure to the surface of the nose of a wearer, including at the side sections of the seal and the outer surfaces of the sides of the nose, wherein an outer surface has regions that are much stiffer than the flexible inner surface, the regions extending into the side section of the seal.

[0015] According to another aspect, the side sections of the seal are essentially parallel to each other and essentially perpendicular to the central section of the seal.

[0016] According to another aspect, the outer walls of the side sections of the seal are aligned in such a way that they form an angle between their orientations of 0 degrees to 30 degrees.

[0017] According to another aspect, the seal has a pair of nasal locators on the face contact side, and the seal is stiffer in the region immediately adjacent to and encompassing the nasal locators than in a region surrounding this region on the face contact side of the seal.

[0018] Another aspect is that a circumferential section of the seal, which connects to the face contact side on the outside, is flexible and allows the inside of the seal to move relative to the outside.

[0019] Another aspect is that the outside of the middle section of the seal has an opening for allowing gases to pass to and from the interior of the seal.

[0020] Another aspect is that the flexible sections of the seal comprise a silicone material with a thickness between 0.05 mm and 0.5 mm.

[0021] According to another aspect, the flexible sections of the seal comprise an elastomer with a thickness between 0.1 mm and 0.2 mm.

[0022] Another aspect is that the rigid sections of the seal comprise a silicone material with a thickness between 2 mm and 5 mm.

[0023] According to another aspect, the rigid sections of the seal comprise an elastomer with a thickness between 2 mm and 3 mm.

[0024] According to another aspect, the region immediately adjacent to and encompassing the nasal locators comprises a silicone material with a thickness between 0.5 mm and 2 mm.

[0025] According to another aspect, the seal has a total width from the outer surface of one side section to the outer surface of the other side section of 30 mm to 60 mm.

[0026] According to another aspect, the seal has a total depth from the outer surface of the middle section to a line connecting to the outermost ends of each side section, of 40 mm to 65 mm.

[0027] According to another aspect, the patient interface has a body assembled to form a nasal seal, the body being formed from a material that is more rigid than the nasal seal and together with the nasal seal forming a housing with an inlet opening and a patient outlet opening, with a pivoting elbow connected to the inlet opening.

[0028] According to another aspect, the connection of the swiveling bow to the body allows for a rotation of the swiveling bow relative to the body and a pivoting of the swiveling bow relative to the body about at least one transverse axis.

[0029] Another aspect is that the connection includes a ball joint.

[0030] According to another aspect, the elbow has a first end and a second end, as well as a flow path between the first end and the second end, wherein the flow path is aligned at the first end in the first direction and at the second end in the second direction, and wherein the first direction and the second direction enclose an angle between 120° and 180°.

[0031] According to another perspective, the angle is between 120° and 150°.

[0032] According to another perspective, the angle is between 130° and 140°.

[0033] Another aspect is that the elbow has a gas washout opening.

[0034] Another aspect is that the gas washout opening is aligned with a gas flow path in the elbow into the nose seal and the body arrangement.

[0035] According to another aspect, the gas scrubbing opening comprises a multitude of holes through a wall of the elbow.

[0036] According to another aspect, the patient interface has a body assembled into a seal and a strap extending from the assembled body and nasal seal in a loop, with the strap starting at a first section of the assembled body and nasal seal at one end and a second section of the assembled body and nasal seal at the other end.

[0037] According to another aspect, the belt comprises a single, undivided band along the length of the belt, which engages in the wearer's head.

[0038] Another aspect is that the belt engages the body at both ends.

[0039] According to another aspect, the body is made of a rigid material, the strap is relatively flexible compared to the body and has a soft section; a part of the strap that engages with the body is made of a material that is more flexible than the body material and less flexible than the strap material, so that when engaging with the body, the soft section forms a soft extension of the body.

[0040] According to another aspect, the soft section extends 5 mm to 60 mm across the belt.

[0041] Another aspect is that the belt engages the body with a detachable connector at each end.

[0042] According to another aspect, the belt has a soft cover section that extends from the detachable connector over a distance of 5 mm to 60 mm across the belt, the soft cover section being formed from a material that is softer than the body.

[0043] Another aspect is that the band is narrow and preferably less than 10 mm wide.

[0044] Another aspect is that the band is less than 6 mm wide.

[0045] According to another aspect, the band exhibits a stiffness of less than 2 N per 100 mm extension from a relaxed state.

[0046] Another aspect is that the band is formed from a knitted or braided yarn that contains material threads with high elasticity and material threads with much higher stiffness.

[0047] According to another aspect, the belt has soft end sections that are stiffer than the belt between the end sections, but softer than the body, with the soft end sections also acting as soft extension sections of the body.

[0048] Another aspect of the patient interface is that it features a tube hanging from the seal and the body, and a tube support that is connected to the tube and can be attached to the neck or clothing of a patient.

[0049] Another aspect is that the hose support has a collar that can be fastened around the wearer's neck.

[0050] According to another aspect, the collar has a first end section and a second end section, wherein the first end section and the second end section have a fastening arrangement which allows the fastening of the end sections with a selected overlap.

[0051] According to another aspect, the collar has a third end section and a fourth end section and a connector that connects the third end section to the fourth end section.

[0052] According to another aspect, if a voltage greater than a release voltage is applied across the connector, the third end section can detach from the fourth end section, where the release voltage is less than 10N.

[0053] Another aspect is that the collar is 30 mm to 60 mm wide.

[0054] According to another aspect, the collar has a core material and a cover material surrounding the core material.

[0055] Another aspect is that the core material is a dimensionally stable, breathable mesh material.

[0056] Another aspect is that the cover material is a braided or knitted natural fiber.

[0057] Another aspect is that the hose support has a tensioning cable extending from the collar, with a connector attached or able to be attached to the hose at one end.

[0058] According to another aspect, the tension cable has a connector at the outer end, with the collar passing through the second connector.

[0059] According to another aspect, the tensioning cable has a first end and a second end and a connector connecting the first end to the second end, wherein the connector can be released when a tension above a release voltage is applied, where the release voltage is less than 10N.

[0060] According to another aspect, the connector of the belt has a first section and a second section, and in the engagement position the first section can be pivoted relative to the second section.

[0061] Another aspect is that the connector for insertion into the hose includes a ring.

[0062] According to another aspect, the patient interface has a body connected to the seal, and the body has a nasal seal insertion section that engages an outer surface of the seal, an inlet opening, and at least one strap insertion section from which a loop strap extends to fix the interface to the patient.

[0063] According to another aspect, the patient interface has a soft intermediate section where the belt loop extends from the belt insertion section, the soft intermediate section being stiffer than the belt but formed from a material that is softer than the body material.

[0064] According to another aspect, the body has two belt engagement sections, with each belt engagement section extending laterally from the inlet opening on opposite sides of the inlet opening.

[0065] According to another aspect, each belt engagement section extends away from the inlet opening in a region where the belt engagement section overlaps the outer wall of the seal.

[0066] According to another aspect, a central section of the body defines a convex shape that generally corresponds to a convex shape of the outer wall of the body, wherein the belt engagement sections extend from lateral extremes of the central section, the belt engagement sections extending away from the central section at an angle directed outwards relative to the generally convex shape.

[0067] According to another aspect, the belt engagement sections extend away from the outer wall of the seal at an included angle of more than 30 degrees.

[0068] According to another aspect, the belt engagement section, from the point where it diverges from the outer wall of the seal, corresponds to between 50% and 150% of the equivalent length of the outer wall of the seal.

[0069] According to another aspect, the patient interface has a body interlocking with the nasal gasket, the body being more rigid than the nasal gasket, with a lip support hanging from the body and extending beyond an edge of the gasket.

[0070] Another aspect is that the lip support has one or more pads for intervention against the upper lip section of the wearer.

[0071] According to another aspect, the lip support has two hanging legs that are spaced apart from each other in each lateral region of the seal, with each leg extending beyond a lateral section of the lower edge of the seal.

[0072] According to another aspect, each thigh carries a padded section that is oriented in such a way that it forms a side that rests against the lower lip.

[0073] According to another aspect, the thighs are shaped in such a way that they have less stiffness around an axis running parallel to the lip section of the wearer with which they come into contact than around an axis running perpendicular to the plane of the lips.

[0074] According to another aspect, the present invention roughly consists of a head attachment part for a patient interface, comprising an elastic band with a width between 3 mm and 6 mm, a stiffness that allows an extension of 150 mm with a force below 2 N, a first end that is connected or can be connected to a first side section of a mask, and a second end that is connected or can be connected to a second side section of a mask.

[0075] Another aspect is that the strap, in its relaxed length, is 300 mm to 400 mm long.

[0076] According to another aspect, the belt is 60 mm to 110 mm longer when an extension force of 1N is applied.

[0077] According to another aspect, the band is formed from a knitted or braided yarn, whereby the yarn has threads of a first material and threads of a second material with high elasticity but much lower stiffness than the first material.

[0078] According to another aspect, the band comprises a braided yarn and the yarn comprises an elastane fiber with a spun sheath.

[0079] According to another aspect, the band comprises a multitude of braided bundles of threads, and each bundle of threads comprises at least two threads, and each thread comprises an elastic anchor and a spun sheath.

[0080] According to another aspect, the first belt end, the second belt end or both have a soft cover section extending 5 mm to 60 mm over the belt, the soft cover section being stiffer than the belt.

[0081] Another aspect is that the cover section is made of a softer material than the side section of the mask to which it is to be connected.

[0082] According to another aspect, the head mounting part has a first connector at the first end and a second connector at the second end.

[0083] According to another aspect, the connector has a flexible, deformable spring clamp that engages in a clamp body.

[0084] According to another aspect, the connector has a cover that surrounds and at least substantially encapsulates the clamp body and a section of the tape, the cover being stiffer than the tape and formed from a material that is softer than the material of the clamp body.

[0085] According to another aspect, the present invention can consist of a patient interface with a belt according to one or more of the above sections.

[0086] According to another aspect, the present invention roughly comprises: a patient interface comprising a nasal seal with a face contact side, wherein the nasal seal is formed from a soft, flexible material; a body assembled to form the nasal seal, wherein the body is formed from a material that is more rigid than the nasal seal and together with the nasal seal forms a housing with an inlet opening and a patient outlet opening; and a lip support that hangs down from the body and extends beyond an edge of the seal.

[0087] Another aspect is that the lip support has one or more pads for intervention against the upper lip section of the wearer.

[0088] According to another aspect, the lip support has two hanging legs that are spaced apart from each other in each lateral region of the seal, with each leg extending beyond a lateral section of the lower edge of the seal.

[0089] According to another aspect, each thigh carries a padded section that is oriented in such a way that it forms a side that rests against the lower lip.

[0090] According to another aspect, the thighs are shaped in such a way that they have less stiffness around an axis running parallel to the lip section of the wearer with which they come into contact than around an axis running perpendicular to the plane of the lips.

[0091] According to another aspect, the patient interface features a gas supply tube hanging from the body and a strap extending in a loop from the assembled frame and nasal seal, with the strap starting at a first section of the assembled body and nasal seal at one end and a second section of the assembled body and nasal seal at the other end.

[0092] According to another aspect, the present invention roughly consists of a patient interface comprising a mask, a tube hanging from the mask, and a tube support connected to the tube and having a collar that can be fastened around the neck of a wearer.

[0093] According to another aspect, the collar has a first end section and a second end section, wherein the first end section and the second end section have a fastening arrangement which allows the fastening of the end sections with a selected overlap.

[0094] According to another aspect, the collar has a third end section and a fourth end section and a connector that connects the third end section to the fourth end section.

[0095] According to another aspect, if a voltage greater than a release voltage is applied across the connector, the third end section can detach from the fourth end section, where the release voltage is less than 10N.

[0096] Another aspect is that the collar is 30 mm to 60 mm wide.

[0097] According to another aspect, the collar has a core material and a cover material surrounding the core material.

[0098] Another aspect is that the core material is a dimensionally stable, breathable mesh material.

[0099] Another aspect is that the cover material is a braided or knitted natural fiber.

[0100] Another aspect is that the hose support has a tensioning cable extending from the collar, with a connector attached or able to be attached to the hose at one end.

[0101] According to another aspect, the tension cable has a connector at the outer end, with the collar passing through the second connector.

[0102] According to another aspect, the tensioning cable has a first end and a second end and a connector connecting the first end to the second end, wherein the connector can be released when a tension above a release voltage is applied, where the release voltage is less than 10N.

[0103] According to another aspect, the connector of the belt has a first section and a second section, and the first section can be pivoted relative to the second section in the engagement position.

[0104] According to another aspect, the present invention roughly comprises: a patient interface comprising a nasal seal with a face-contact side, wherein the nasal seal is formed from a soft, flexible material, and a central section extending over the base of the nose, and a side section extending from each end of the central section, each side section extending over the side of the nose; a body connected to the seal comprising a nasal seal engagement section engaging an outer surface of the seal, an inlet opening, and at least two strap engagement sections, each strap engagement section extending laterally from the inlet opening on opposite sides of the inlet opening; and a strap extending between the strap engagement sections;and wherein a central section of the body defines a convex shape which generally corresponds to a convex shape of the outer wall of the body, wherein the belt engagement sections extend from lateral extremes of the central section, wherein the belt engagement sections extend away from the central section at an angle directed outwards relative to the generally convex shape.

[0105] According to another aspect, the belt engagement sections extend away from the outer wall of the seal at an included angle of more than 30 degrees.

[0106] According to another aspect, the belt engagement section, from the point where it diverges from the outer wall of the seal, corresponds to between 50% and 150% of the equivalent length of the outer wall of the seal.

[0107] According to another aspect, the patient interface has a soft intermediate section where the belt loop extends from the belt insertion section, the soft intermediate section being stiffer than the belt but formed from a material that is softer than the body material.

[0108] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising: a head strap with a single loop, a mask for covering at least the nostrils of the user, wherein the single-loop head strap extends from the mask at both ends, and a supply line with a length of less than 200 mm, which is connected to the mask for free pivoting movement including significant rotation about several orthogonal axes.

[0109] Another aspect is that the supply hose is flexible enough that the hose can withstand the pressure described herein with regard to Fig. The 64 described tests are passed.

[0110] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising: a mask for covering at least the nostrils of the user, a supply opening on the mask for receiving supplied gases, a bias flow vent on the mask extending from an inside of the mask to an outside of the mask, wherein the bias flow vent directs the flow in a direction of less than 45° to the frontal plane of the head of a hypothetical wearer and in a direction generally towards the forehead.

[0111] According to another aspect, bias flow venting includes at least one bias flow opening in a wall of the mask, with the section of the wall containing the bias flow opening being oriented at more than 45° to the frontal plane of the wearer.

[0112] According to another aspect, the section of the wall with the bias flow openings is arranged in a front wall of the mask, and the section forms a border in relation to a surrounding section of the front wall.

[0113] Another aspect is that a large number of bias flow holes are distributed in an arc around the upper front section of the interface.

[0114] Another aspect is that the mask has a general U-shape or V-shape so that it can be wrapped around the user's nose, and the bias flow vent is located at the bottom of the U or V.

[0115] Another aspect is that the seal does not cover the bridge of the wearer's nose.

[0116] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising the following: a frame and a seal, wherein the seal has a patient-facing side with at least one patient opening and a frame-facing side with at least one frame-facing side, wherein the seal engages in the frame at a lip defined by the circumference of the frame-facing opening, wherein the frame has a first component and a second component, wherein the first component has a first section for engagement in the lip of the seal, wherein the seal can be brought into and out of engagement with the channel, while the first and second components are connected to form the channel.

[0117] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising the following: a frame and a seal, wherein the frame has engaging first and second components, wherein the first component has a section forming a socket with surfaces for contact with moving parts of a freely pivoting connector, wherein the second part comprises an outer cover with an opening at the location of the socket of the first part, and wherein the patient interface further comprises a connector with a connecting part that projects beyond the cover into the socket of the first part for engagement with the socket of the first part for free pivoting movement.

[0118] According to another aspect, the first component is made of a different material than the cover, and the cover and the connector are made of the same material.

[0119] According to another aspect, the patient interface features a seal with a pair of nasal locators extending from a flexible background, each nasal locator having a tip and the nasal locator becoming narrower from the background to the tip, and an opening in the tip of the nasal locator, wherein the opening and the cross-sectional profile of the tip portion of the nasal locator are oval or elliptical and have a ratio of major axis length to minor axis length of over 1.5.

[0120] According to another aspect, the ratio of the length of the main axis to the length of the secondary axis is between 1.5 and 3.

[0121] According to another aspect, the tip section of the nasal locator has a lip next to the tip opening, with the lip being thickened in relation to the adjacent sections of the tubular section.

[0122] According to another aspect, the nasal locator has a dome-shaped section next to the background and a tubular section extending from a tip of the dome-shaped section.

[0123] According to another aspect, the dome section extends at least 60% around the nasal locator.

[0124] According to another aspect, the dome section extends completely around the nasal locator.

[0125] According to another aspect, the tubular section tapers and extends from the dome section to the tip section.

[0126] According to another aspect, the cross-section of the nasal locator in planes parallel to the plane of the tip opening is oval or elliptical over the entire tubular section and the upper parts of the dome section.

[0127] According to another aspect, the ratio of the length of the main axis of the oval cross-section to the length of the secondary axis of the oval cross-section gradually decreases from the top of the tubular section to the bottom of the dome section.

[0128] According to another aspect, the flow projection axes of the two nasal locators converge at a point between 10 mm or 40 mm from the tips of the nasal locators.

[0129] According to another aspect, the central axis of the nasal locator converges when projected beyond the tips of the locators, and becomes narrowest at a point 10 mm to 20 mm behind the tips of the nasal locators.

[0130] According to another aspect, the oval shapes of the tip openings are aligned when the tip openings of the nasal locators are projected onto the frontal plane of a hypothetical wearer, such that the principal axes converge at an angle between 60 degrees and 120 degrees.

[0131] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising the following: a frame and a seal, wherein the seal has a patient-facing side with at least one patient opening and a frame-facing side with at least one frame-facing side, wherein the seal engages in the frame at a lip defined by the circumference of the frame-facing opening, wherein the frame has a front face section in the region of a pivot connection to a feed line, wherein the front face section is inclined relative to the frontal plane of the hypothetical interface carrier such that the lower edge of the section is closer to the frontal plane than the upper edge of the section, and wherein the connector reverses the flow from an inlet to the connector to an outlet of the connector by an angle between 30 degrees and 70 degrees.wherein the connector and the inclined outer facial section of the mask frame together allow free pivoting movement of the lead, the lead being able to assume a position more or less parallel to the frontal plane of the hypothetical wearer, and the connector remaining close to the wearer's face.

[0132] Another aspect is that the connector does not have bias flow venting.

[0133] In another aspect, it can be roughly stated that the present invention consists of a patient interface comprising the following: a frame and a seal, wherein the seal has a patient-facing side with at least one patient opening and a frame-facing side with at least one frame-facing side, wherein the seal engages in the frame at a lip defined by the circumference of the frame-facing opening, wherein the frame has a feed opening through a front wall of the frame, wherein an annular section extends from the front wall to define a passage from the inside of the front wall of the frame, and wherein a projecting wall extends around the inwardly open end of the annular section and engages in the lip of the seal.wherein the front wall of the frame and the ring section together with the other frame parts define an air chamber with a bias flow vent through a wall of the air chamber and an open area between the ring section and the structure of the channel provides a flow path between the interior of the seal and the air chamber.

[0134] According to another aspect, the bias flow holes are arranged through the wall of the frame in an area of ​​the upper section of the air chamber.

[0135] According to another aspect, the ring section is formed as part of a first component of the frame, and the front wall of the frame is formed as part of a second component, with the two components being attached to each other to define the air chamber.

[0136] According to another aspect, the projecting wall includes a channel, with the channel receiving the lip of the seal.

[0137] According to another aspect, the channel follows a closed arc path with a total width that is greater than its height, so that the air chamber is formed predominantly on both sides of the ring section.

[0138] According to another aspect, the ring section connects to the upper and lower middle sections of the projecting wall, and the flow path from the seal to the air chamber passes through both sides of the ring section.

[0139] According to another aspect, the projecting wall is shaped as part of the same component as the ring section.

[0140] According to another aspect, the bias flow vent is formed by the front wall of the second component.

[0141] According to another aspect, the first component has laterally projecting shield sections, with the inner sides of the shield sections fitting against the outer sides of an outer wall of the seal to limit the deflection of the seal outwards.

[0142] According to another aspect, the second component has downward and sideways hanging stabilizers for stabilization on the upper lip region of a wearer.

[0143] According to another aspect, the first frame component comprises a skeletal frame, with at least some of the stabilizer parts of the component comprising a sheathed soft material.

[0144] In another aspect, it can be roughly stated that the present invention consists of a patient interface with a soft, flexible seal, a rigid frame, a head attachment part connected to the frame, rigid projections at the connection of the head attachment part with the frame, wherein the head attachment part is very flexible within 60 mm of the frame, and between this point and the projections a soft section which is stiffer than the flexible section of the head attachment part, but is made of a softer material than the rigid frame.

[0145] From another perspective, the protrusions resemble tines and are long and slender.

[0146] According to another aspect, the soft section extends from the general path of the prongs.

[0147] According to another aspect, the protrusion consists of a combination of a section of the mask frame and a clamp section of the head mounting part.

[0148] From another perspective, the soft section is part of the head mounting part.

[0149] Another aspect is that the head fastening part is a simple strap with a loop.

[0150] Another aspect is that the protrusions extend laterally beyond the width of the seal.

[0151] From a further perspective, it can be roughly stated that the present invention consists of a patient interface with a seal having a pair of nasal locators extending from a flexible background, each nasal locator having a tip and the nasal locator becoming narrower from the background to the tip, and an opening in the tip of the nasal locator, the nasal locator further comprising a domed section adjacent to the background and a tubular section extending from a tip of the domed section.

[0152] According to another aspect, the dome section extends at least 60% around the nasal locator.

[0153] According to another aspect, the dome section extends completely around the nasal locator.

[0154] According to another aspect, the tubular section tapers and extends from the dome section to the tip section.

[0155] According to another aspect, the cross-section of the nasal locator is oval or elliptical in planes parallel to the plane of the tip opening over the entire tubular section and the upper parts of the dome section.

[0156] According to another aspect, the ratio of the length of the main axis of the oval cross-section to the length of the secondary axis of the oval cross-section gradually decreases from the top of the tubular section to the bottom of the dome section.

[0157] According to another aspect, the flow projection axes of the two nasal locators converge at a point between 10 mm or 40 mm from the tips of the nasal locators.

[0158] According to another aspect, the central axis of the nasal locator converges when projected beyond the tips of the locators, and becomes narrowest at a point 10 mm to 20 mm behind the tips of the nasal locators.

[0159] According to another aspect, the tip opening and the cross-sectional profile of the tip section of the nasal locator are oval or elliptical with a ratio of the length of the major axis to the length of the minor axis of over 1.5.

[0160] According to another aspect, the ratio of the length of the main axis to the length of the secondary axis is between 1.5 and 3.

[0161] According to another aspect, the tip section of the nasal locator has a lip next to the tip opening, with the lip being thickened in relation to the adjacent sections of the tubular section.

[0162] According to another aspect, the oval shapes of the tip openings are aligned when the tip openings of the nasal locators are projected onto the frontal plane of a hypothetical wearer, such that the principal axes converge at an angle between 60 degrees and 120 degrees.

[0163] According to another aspect, the invention can consist of an interface following any of the multitude of preceding sections.

[0164] The term "comprising," as used in the description and claims, means "consisting at least partially of." When interpreting a statement in this description and the claims that contains the term "comprising," features other than those introduced by the term may also be present. Related terms such as "encompass" and "includes" are to be interpreted in the same way. When this patent specification refers to other patent specifications, other external documents, or other sources of information, this is generally done to provide context for discussing the features of the invention. Unless specifically stated otherwise, references to such external documents are not to be construed as an endorsement that these documents or sources of information form part of the prior art or are part of the generally accepted state of the art under any jurisdiction. BRIEF DESCRIPTION OF THE DRAWINGS

[0165] Preferred embodiments of the present invention are described with reference to the accompanying drawings. Fig. is a perspective view of a person wearing a patient interface. Fig. is a perspective view of the patient interface from Fig. 1 without a patient. Fig. 3 is a disassembled representation of the components that make up the interface. Fig. 2 exists. Fig. Figures 4A to 4C show a sealing component of the patient interface from different angles. Fig. 2. Fig. 4A shows the sealing component from an outward-facing side, Fig. 4B shows the seal from a side facing the patient and Fig. Figure 4C shows a side view of the seal. Fig. 5A is a split view of the seal and mask frame, showing how they can be joined and assembled. Fig. 5B is a side view of the interface from Fig. 2, partially disassembled to show the connection of an elbow to the mask frame. Fig. 5C is a perspective front view of the interface from Fig. 2, which shows how the elbow is assembled with the mask frame, with a gas washout opening in the elbow. Fig. Figure 6 is a front view of the assembled seal with mask frame. Fig. 7A is a top view of the assembled seal with mask frame. Fig. 7B is a side view of the seal and frame made of Fig. 7A without subdivision. Fig. 7C is a view of the patient side of the seal. Fig. 4A and Fig. 4C. Fig. 7D is a side view of the seal made of Fig. 7C, intersected by line EE. Fig. Figure 8 is a side view of the seal and mask frame made of Fig. 7A through line DD. Fig. 9A is a top view of the seal made of Fig. 7C, cut by line FF in Fig. 7D. Fig. 9B is a top view of the seal made of Fig. 7C, intersected by line GG in Fig. 7D. Fig. Figures 10A to 10C are perspective views of a patient interface that incorporates a number of inventions described in this patent specification. Fig. 10A is a front view, Fig. 10B is a profile view and Fig. 10C is a view from the rear. Fig. 11A to 11H are views of the soft sealing component of the interface. Fig. 10A to 10C. Fig. 11A is a top view. Fig. 11B is a front view. Fig. 11C is a rear view from a position pointing directly towards the open end of a nasal locator. Fig. 11D is a cross-section through section CC in Fig. 11C. Fig. 11E is a cross-section through line DD in Fig. 11C. Fig. 11F is a cross-section through line EE in Fig. 11E. Fig. 11G is a cross-section through line GG in Fig. 11E. Fig. 11H is a cross-section through line HH in Fig. 11E. Fig. 12A to 12H are views of a frame arrangement of the interface. Fig. 10A to 10C. Fig. Figure 12A is a perspective front view of the frame arrangement. Fig. Figure 12B is a perspective rear view of the frame arrangement. Fig. 12C is a side profile of the frame arrangement. Fig. 12D is an assembled view of two components of the frame arrangement. Fig. Figure 12E is a rear view of the frame arrangement. Fig. 12F is a front view of the frame arrangement. Fig. 12G is a side view in cross-section through line AA of Fig. 12F. Fig. 12H is a top view in cross-section through line BB of Fig. 12F. Fig. Figure 12I is a rear view of an alternative frame arrangement with a different channel path for fixing the sealing lip. Fig. Figure 13 shows another embodiment of an interface with an inflatable seal. The interface comprises a sealing body, a frame, a hose, and a head strap. Fig. Figure 14 shows the sealing body of the interface. Fig. 13. Fig. Figure 15 is a perspective view of the frame and sealing body of the interface. Fig. 13. Fig. Figure 16 is a front view of the frame and sealing body of the interface made of Fig. 13. Fig. Figure 17 is a side view of the frame and sealing body of the interface made of Fig. 13. Fig. 18 is a cross-section through the frame and the sealing body through BB in Fig. 17. Fig. Figure 19 shows another cross-sectional view of the sealing body. Fig. 20 is a cross-section through the sealing body through AA in Fig. 16. Fig. 21 is an alternative embodiment of a sealing body of the interface according to the invention. Fig. 22 is another embodiment of a sealing body of the interface according to the invention. Fig. 23 is another embodiment of a sealing body of the interface according to the invention. Fig. Figure 24 shows a first embodiment of a head strap that can be used with an interface according to the invention. Fig. 24a and Fig. Figure 24b shows two alternative cross-sections through the head strap. Fig. 24. Fig. Figure 25 shows a second embodiment of a head strap that can be used with an interface according to the invention. Fig. 25a and Fig. Figure 25b shows two alternative cross-sections through the head strap. Fig. 25. Fig. Figure 26 shows a third embodiment of a head strap that can be used with an interface according to the invention. Fig. Figure 27 shows a fourth embodiment of a head strap that can be used with an interface according to the invention. Fig. Figure 27a shows the extendable section of the head strap made of Fig. 27 in extended and contracted states. Fig. Figure 28 shows a fifth embodiment of a head strap that can be used with an interface according to the invention. Fig. Figure 29 shows a sixth embodiment of a head strap that can be used with an interface according to the invention. Fig. Figure 29a shows the sections of the headband of Fig. 29. Fig. Figure 30 shows a first embodiment of the connection between a sealing body and the frame of the interface according to the invention. Fig. Figure 31 shows a second embodiment of the connection between a sealing body and the frame of the interface according to the invention. Fig. Figure 32 shows a third embodiment of the connection between a sealing body and the frame of the interface according to the invention. Fig. Figure 33 shows a fourth embodiment of the connection between a sealing body and the frame of the interface according to the invention. Fig. Figure 34 shows a first embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 35 shows a second embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 36 shows a third embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 37 shows a fourth embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 38 shows a fifth embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 39 shows a sixth embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 40 shows a seventh embodiment of a support which can be used with the interface according to the invention to attach a hose connected to the interface to the user. Fig. Figure 41 is a perspective view of a support collar. Fig. 42 is a perspective view of a patient wearing the support collar. Fig. Size 41. Fig. 43 is a perspective view of the collar from Fig. 41 from a different angle. Fig. 44 is a front view of a patient who has removed the collar. Fig. Size 41. Fig. 45 is a top view of the collar made of Fig. 41. Fig. Figure 46 is a top view of part of the collar made of Fig. 41, which shows a dome-shaped fastening element. Fig. Figure 47 is a top view of part of the collar with another fastening element. Fig. Figure 48 is a top view of part of the collar with another fastening element. Fig. Figure 49 is a top view of part of the collar with another fastening element. Fig. 50A is a side view of part of the collar with a fastening clip in the engaged position. Fig. 50B is a side view of the part of the collar made of Fig. 50A out of service. Fig. 51A is a side view of part of the collar with a fastening clip according to another embodiment out of engagement. Fig. 51B is a side view of the part of the collar made of Fig. 51A in engagement position. Fig. Figure 52 is a perspective view of a tension cable hanging from part of the collar, the tension cable having a quick-release connector. Fig. Figure 53 is a perspective view of a tension cable hanging from the collar, the tension cable having a quick-release connector which is also swivel-mounted. Fig. 54A is a top view of a tension cable similar to the tension cable from Fig. 51B, but it's only minimally long. Fig. 54B is a top view of the tension cable made of Fig. 54A, where the quick-release connector is out of engagement. Fig. 54C is a side view of the tension cable made of Fig. 54A. Fig. Figure 55 is an expanded representation of the connection of a ring of the tension cable from the support collar to a conduit. Fig. Figure 56 is a perspective view of an interface with an alternative arrangement to support patient performance. Fig. Figure 57 is a perspective view of a patient wearing an interface with an alternative arrangement to support the line on the patient. Fig. Figure 58 is a side view of a frame and a seal, wherein the frame has hanging lip stabilizers according to a further invention herein. Fig. Figure 59 is a top view of the frame and the seal made of Fig. 58. Fig. Figure 60 is a front view of the frame and seal made of Fig. 58. Fig. 61 is a perspective view of an interface with the frame and the seal made of Fig. 58. Fig. Figure 62 is a graphic representation of tested tensile forces against expansion of samples of belt materials. Fig. 63A to 63C illustrate aspects of a preferred head mounting part of the interface from Fig. 10A to 10C. Fig. 63A is a perspective view of part of a head fastening component with one end of a head strap and a connector. Fig. 63B is a top view of the belt and connector. Fig. Figure 63C is a view showing (in cross-section) both the connector and the socket of the frame assembly that accommodates the connector in use. Fig. 63D and Fig. Figure 63I illustrates another preferred head mounting part. Fig. Figure 63D shows part of the head mounting part, the connector and part of the frame assembly to which it is connected. Fig. 63E is a top view of the arrangement made of Fig. 63D. Fig. 63F is a section view through line AA from Fig. 63E. Fig. 63G is a side view of the belt section and connector made of Fig. 63E. Fig. 63H is a cross-section through line BB of the connector and the belt section made of Fig. 63G. Fig. 63I is an assembled drawing of an exploded view of the belt section and connector made of Fig. 63G. Fig. 63J is a perspective view of the belt section and the connector made of Fig. 63G. Fig. Figure 64 is a graphic representation of the tested tensile force against elongation of another sample of the belt material. Fig. Figure 65 is a diagram of a test device for measuring the flexibility of a breathing tube. DETAILED DESCRIPTION

[0166] The invention relates in particular, but not exclusively, to an interface comprising an inflatable nasal seal with a flexible wall structure. The inflatable seal has a pair of localization projections that engage in the user's nostrils. The localization projections direct gas flowing from the inside of the seal to the user. The patient-facing side of the seal is sufficiently flexible and adequately sized and shaped to conform to the surfaces of the user's face (particularly the sides of the nose and the upper lip) when the inflated seal is pressed against the user's face, with the localization projections engaging in the user's nostrils and sealing them. An outward-facing wall of the seal is more rigid and supports the inner wall of the seal in a position where the seal is wrapped around the wearer's nose.

[0167] The seal is made of a material with sufficient elasticity and tensile strength to make the sleeve flexible. The flexible section can withstand repeated drastic deformation without failure. Possible materials include latex, vinyl, silicone, and polyurethane. Typical wall thicknesses of the flexible sections of the seal would be less than 0.5 mm; however, they could also be less than 0.2 mm. The seal body features a pair of nasal locators projecting from the patient-facing wall. Preferably, the nasal locators are integrally molded with the seal. Each nasal locator has an outlet opening for the delivery of gases from the inside of the sleeve to a user wearing the interface.

[0168] The seal body has an inlet opening located approximately opposite the nasal locators. A substantial portion of the seal body, or shell, is flexible. A region adjacent to and encompassing the nasal locators, and a region adjacent to and encompassing the inlet opening, are much stiffer. These areas maintain the overall shape of the seal and can have any suitable stiffness. These areas can be molded from a stiffer material, or they can be molded from the same material but thicker than the rest of the shell.

[0169] The seal is supported by a mask body or frame. The seal's inlet opening is located on the frame or directly on a conduit extending through the frame.

[0170] The frame is preferably a minimal design that hardly obstructs vision, ensuring a clear field of view and allowing the user to wear glasses while wearing the interface. The frame can be injection-molded from an elastomeric material such as silicone or polyurethane. Alternatively, more rigid materials like polycarbonate, polyester, polystyrene, or nylon can be used.

[0171] The preferred frame has connection points for attaching straps to the frame. The strap attachment points allow the straps to be anchored.

[0172] In other embodiments, the nose seal body can have integrated strap attachment points. These attachments can be fasteners on the surface of the shell. However, they could also be integrated straps or wings molded into the shell and extending from both sides of the shell.

[0173] The interface should be supported by a single strap that runs around the back of the head. The strap can be made of an elastic or elastomeric material. Suitable strap materials include, for example, a woven elastic strip or a narrow strip of foam or fabric, such as Breathoprene™. The strap running around the back of the head applies pressure to the mask and helps ensure a proper seal against the user's face.

[0174] A preferred belt according to one or more inventions herein will be described later in this patent specification.

[0175] A flexible tube extends from the frame. The flexible tube delivers breathing gas. The distal end of the flexible tube is connected to the CPAP main supply tube.

[0176] A connector can join the hose to the frame. The connection mechanism can be any suitable connection. This could include a snap connection, hooks in the silicone, keyhole inserts, overmolding, insert molding, screw fixings, or adhesive bonding, or any combination thereof.

[0177] The connector may have a restricted flow outlet (or bias flow outlet (breathing gas crossflow outlet)) for scrubbing gas from the interface. The outlet may be in the form of a cluster of small openings within the connector. Internally, the connector may have a funnel or extension from the vent to the sheath opening. Alternatively, the connector may not have a bias flow vent.

[0178] Fig. 1 and Fig. Figure 2 shows an example of a patient interface with the inventions disclosed in this patent application. For clarity, the patient interface is shown separate from the patient. Fig. 2 shown while Fig. Figure 1 shows how it is worn by a patient.

[0179] The patient interface 101 roughly comprises a mask 103, a strap 105 for attaching the mask to the patient, a flexible supply line 107 connected to the mask 103, and a line support structure 109 attached to the patient, which bears the weight of the line section 107 and any connected line that carries gases to the inlet end 111 of the line section 107.

[0180] Certain aspects of this patient interface and variations of each aspect are discussed with reference to the other figures. An interface may have some aspects but not others. For example, an interface might have aspects of the mask, while a different arrangement is used to attach the mask to the user. An interface might have a different mask, while aspects of the strap according to the invention are used to attach the mask to the user. An interface may have aspects of the mask but not use a similar or any construction to support the weight of the line from the patient's body. These variations all fall within the scope of this application.

[0181] Referring to Fig. The mask 103 fits over the patient's nostrils and has side sections that curve around each side of the nose. These side sections create a perimeter seal on the outward-facing surfaces of the nasal flanks. The strap 105 runs in a simple loop around the user's head, over their ears.

[0182] The conductor section 107 hangs down from a central section 113 at the front of the mask 103. The central connection 113 is preferably a swivel elbow, so that the conductor path can be adjusted to the patient's sleeping position relative to the positioning of the mask on the patient's face. The swivel elbow can be in the form of a ball joint, so that the elbow can pivot about axes that are parallel and perpendicular to its connection with the mask.

[0183] The cable support 109 shown includes a collar 115 that is placed around the user's neck. A tension cable 117 connects the collar to the cable 107.

[0184] The components of this exemplary interface are in Fig. Figure 3 shows that the mask 103 has a seal 301 and a body or frame 303. The seal and body are described in more detail in Figure 3. Fig. 5A is shown. Their intervention is described in relation to Fig. 5A and Fig. 8 described in more detail.

[0185] The body 303 has a socket 305 and connector sections 307. The socket 305 receives an engagement section 311 of the elbow 313. The elbow 313 is connected to one end of a length of flexible tubing 315. The other end of the flexible tubing 315 terminates in a cuff 317. The connector sections 307 of the mask body 303 are designed to engage with connector sections 321 of the head strap 105. The head strap 105 has a single length 323 made of stretchable material. The connector sections 321 are provided at both ends of the length 323.

[0186] The collar 115 features a band 325 made of a material designed for comfort during sleep. The band has a first adjustable connection 327 and a second non-adjustable connection 329. At the adjustable connection 327, the free ends of the band overlap, and the degree of this overlap can be varied and fixed as desired. At the non-adjustable connection 329, the free ends of the band can be easily fixed or released. After adjusting the adjustable connection 327, the collar can be opened and applied to the patient, or removed and, after application, secured by releasing or connecting the non-adjustable connection 329. The non-adjustable connection 329 can be a quick-release connector that detaches when tension is applied within a predetermined range.This ensures that the collar will detach without injuring the patient if an adverse situation arises.

[0187] The tension cable 109 has a first section 331, which is attached to the collar, and a second section 333, which is attached to the conductor. These sections are preferably engaged with each other via a quick-release connector, which preferably releases when a tension within a predetermined range is applied.

[0188] The tension cable section 333 is connected to the conduit 315. The tension cable section 333 has a section of the quick-release connector and a connecting piece 337 that engages the conduit. The connecting piece 337 can be an open clamp for engaging a corrugation of the conduit or a recess in the sleeve 317, or for engaging around the generally cylindrical shape of the conduit or a cylindrical section of the sleeve. Alternatively, and as shown, the section 337 can comprise a ring that fits around a portion of the conduit or a portion of the sleeve. In the embodiment shown, the ring 337 is caught between the sleeve 317 and a connector section of a swivel bearing 335. The ring fits over a portion 339 of the sleeve 317 and is held by an end section 341 of the swivel bearing 335, the diameter of which is larger than the inner diameter of the ring.

[0189] The external shape of a preferred seal is in Fig. 4A to 4C shown. Seal 301 has a patient-facing side, which is in Fig. 4B is roughly shown, and an outward-facing side, which is roughly in Fig. Figure 4A shows a pair of nasal locators 401 protruding from the patient-facing side. Generally speaking, the wall of the gasket forming the patient-facing side is very flexible except at the nasal locators, the area immediately adjacent to the nasal locators, or both. Variations in flexibility are described with reference to the information in Fig. 7D, Fig. 8 and Fig. 9A and Fig. The cross-sections shown in 9B are described in more detail.

[0190] In its overall form, the seal has a central section with nasal locators on the patient-facing side and an opening 403 on the outward-facing side. The extent of this central section 407 is roughly indicated by the dashed line 409 in Fig. 4C and Fig. 4A indicated. For clarity, the broken line 409 is also in Fig. Figure 7A shows a top view of the mask section of the interface.

[0191] Side sections 411 extend from the central section 407. Each side section has an outer surface 413 and an inner surface 415, as well as a peripheral edge section 417 that adjoins the inner surface section and the outer surface section. The peripheral edge section 417 extends around an upper edge 419, a terminal edge 423, and a lower edge 420. Thus, viewed from the inside of the seal, the side sections 411 resemble a pocket.

[0192] Each side section is quite extended. Preferably, the side section extends over more than 10 mm (particularly preferably over more than 20 mm) or at least over a distance of 70% of the distance separating the centers of the nose locators 401, to behind the base of each nose locator.

[0193] At least the inner wall 415 and the circumferential wall 417 of each side section are very flexible, allowing them to conform to the contours of the user's face, and in particular to the contours of the outer sides of the user's nose. At least parts of the outer wall 413 of the side section are also flexible, but this flexibility may decrease progressively towards the central section 407.

[0194] The central section 407 of the seal has an opening 403 for guiding a gas flow to and from the mask body 303. The opening 403 may have features such as lips and / or channels for engaging with features such as channels and / or lips on the body 303. The opening 403 may be formed with clamping sections, or clamping sections may be formed on or around the circumference of the opening 403 to facilitate engagement with the frame 303. Typically, the opening 403 is considerably thicker and more rigid than the flexible sealing sections of the seal 301. The opening 403 should have at least the size of the inner cross-section of the supply line 315. Preferably, and as shown, the opening 403 corresponds to the dimensions of the mask body 303, these dimensions being the overall width of the interface and approximately the width of the nose of the intended wearer.

[0195] In the preferred embodiment, the interface is small and the body section 303 of the mask bends to approximately follow the contour of the wearer's upper lip, and the seal is shaped such that the opening 403 follows this approximate curve in a plane.

[0196] The central section 407 of the seal extends above and below the opening 403. Above the opening 403 and the nostril locators 401, the central section has an outwardly facing wall 431, an inwardly facing wall 433, and a perimeter section 435. At least the inwardly facing wall section 433 and the outwardly facing wall section 435 are preferably thin and flexible.

[0197] Below the opening 403, the central section 407 has an outer wall section 441, an inner wall section 443, and a circumferential section 445. At least the inner section 443 and the circumferential section 445 are preferably thin and flexible.

[0198] In use, the flexible inner wall sections above, below, and beside each side of the nasal locators are inflated by pressure present in the seal (from the flowing gases supplied to the patient interface) to press against the wearer's skin and conform to the contours of the outer surfaces of the wearer's nose, the underside of the nose, and the upper lip immediately below the nose. Movement of the mask body does not break this seal because the flexible perimeter of the seal allows the mask body to move, at least to a small extent, in the direction of movement. The flexible perimeter releases the nasal locators from their position on the mask body, allowing the mask body to move both laterally and vertically (relative to the axes of the patient's face).The side sections 411 engage the sides of the patient's nose, forming a certain seal on the sides and supporting the position of the mask.

[0199] The mask body and the seal are in Fig. 5A and in Fig. 5B and Fig. Figure 5C is shown in a larger format. As previously described, the seal has an opening 403 with features for attaching the seal to the mask body. The mask body has a socket 502 for connection to the supply line and a sealing opening 501 for engaging the opening 403 of the seal. The sealing opening 501 and the opening 403 of the seal are provided with complementary features for mutual engagement. In the embodiment shown, the sealing opening 403 has an arrangement 507 of a lip and channels, and the circumference of the sealing opening 501 of the mask body has a complementary arrangement 505 of channels and lips. The arrangement of the channels and lips is intended to ensure that there are no leaks in the connection when the seal is correctly fitted onto the mask body and supplied with pressurized gases.Many other ways of connecting the seal to the mask body are conceivable, and this arrangement serves only for illustration.

[0200] In the mask body, the outlet opening 501 for sealing the opening of the bushing 502 is located directly opposite it, so that the opening 502 is centrally positioned. Each side of the bushing 502 extends a central side section 509. The central side section 509 can be a simple cover wall that surrounds part of the opening 403 of the seal. The central side sections 509 can have small openings as part of a gas scrubbing opening.

[0201] In the preferred embodiment shown, side arms 511 extend beyond the extent of the sealing opening 501, which is best achieved in Fig. Figure 7A shows the side arms 511 preferably extending beyond the extreme width of the seal. Each side arm 511 has a connector section 513 for connection to the connector section 321 of the belt. In the illustrated embodiment, the connector sections comprise a fixing post with a perimeter notch. The belt has a small loop at each end that stretches over the fixing post and engages in the notched recess. This connector embodiment is simple and intuitive, but other connector embodiments can also be provided; for example, each side arm 511 could be provided with a part (for example, a male or female part) of a clamp.

[0202] How best to Fig. As can be seen in Figure 7A, the side arms 511 diverge from the outer wall of the seal, for example at an angle 713 of 30° to 80°. A strap attached to the post 513 exits the side arm at the angle defined by line 715. Fig. 7A, at a location spaced apart from the seal and the face of the carrier. This is illustrated by the relative positions of the tip 717 of the side arm 511 compared to the center line 719 of the interface. The distance 721 from the center line to the tip of the side arm is preferably 25 mm to 50 mm, more preferably approximately 45 mm. This corresponds to the distance 723 between the center line 719 and the central axis of the nose locator, which is preferably 5 mm to 10 mm, more preferably approximately 7 mm. This also corresponds to the approximate position of the inner wall surface of the side section of the seal where it exits the central section of the seal. This position is indicated by the dashed line 725 in Fig. Figure 7A illustrates this. Preferably, this distance 727 is 10 mm to 20 mm and particularly preferably approximately 15 mm. For further comparison, the outermost extent of the side section is shown by the dashed line 729. The displacement 731 of the dashed line 729 from the center line 719 is preferably 15 mm to 30 mm and particularly preferably 25 mm.

[0203] In the forward and backward directions, the tips 717 are preferably located at the rear of the base of the nasal locators, so that the bases of the nasal locators lie between the middle section of the mask body and a line connecting the tips 717.

[0204] Further referring to Fig. 7A The mask seal can have a total maximum outer dimension 741 of between 30 mm and 60 mm, and particularly preferably of approximately 50 mm. The seal and the mask frame can have a total depth 743 preferably of between 40 mm and 65 mm, and particularly preferably of approximately 55 mm. Within this depth, the interior space defined by the seal, which wraps around the user's nose during use, can have a depth 745 preferably of between 20 mm and 40 mm, and particularly preferably of approximately 30 mm.

[0205] As in Fig. As can be seen in Figure 7A, the seal, in its overall shape, follows a curve through a considerable arc, so that the side sections are generally parallel to each other and opposite each other across the gap that accommodates the nose. The orientation planes of the side sections can together form an angle of 0° to 45° and preferably 0° to 25°. This preferably applies to the inner wall and the outer wall as shown in Figure 7A. Fig. 9A and Fig. 9B shown. Preferably, this also applies to substantially all vertically displaced planes within the seal, as shown by the various planes in Fig. 9A and Fig. 9B is shown.

[0206] The flat overall plan shape of the seal as in Fig. Figure 7A could be considered parabolic, semi-elliptical, semi-oval, or U-shaped. Generally speaking, the central section of the seal defines its width, with the side sections extending from the endpoints of the central section in a direction substantially parallel to each other and substantially perpendicular to this width dimension. Fig. 5B and Fig. Figure 5C also shows the connection of the pivoting elbow 313 to the mask body 303. The pivoting elbow 313 has a spherical section 515 and an opening 517. The outer surface of the spherical section 515 is preferably a frustoconical surface, but it can also be shaped differently and still form a substantial seal with the bushing 502. Similarly, the bushing 502 is preferably a frustoconical surface with a slightly inwardly tapering lip. This is best illustrated in Fig. Figure 8 shows where the lip 802 runs slightly inwards relative to the rest of the frustoconical surface 804.

[0207] The swivel elbow 313 preferably defines an angle between the flow in the conduit and the flow through the connection to the mask of 0° to 90°, preferably of 30° to 60°, and particularly preferably of approximately 45°. The elbow may have openings 519 that form part of the gas washout opening or the entire gas washout opening of the patient interface. The openings are preferably located on the outside of the bend of the elbow, essentially in line with the flow path of the gases leaving the mask.

[0208] Fig. 5B and Fig. Figure 5C also shows the connector sections 321 of the belt, which engage via the post 513 of the mask body.

[0209] Fig. Figures 7A to 7D show the context for the cross-sections that are in Fig. 8, Fig. 7D, Fig. 9A and Fig. 9B are shown.

[0210] Fig. 7D is a cross-section through line EE of the seal made of Fig. 7C. Fig. Figure 7D illustrates the thickness of the seal sections in the vertical midplane of the seal. This shows a thickening of the seal in region 731 immediately adjacent to and between the nose locators. The cross-section also shows a thickening of the seal in the outer wall section 431 of the central section of the seal above the outlet 403 and a thickening of the outer wall section 441 of the central section below the opening 403. These thickened sections preferably increase in thickness gradually from the thin flexible perimeter sections 435 and 445 to a thickness of approximately 2 mm to 4 mm. The flexible wall sections, i.e., the peripheral sections 435 and 445, the lower inner wall section 443, and the upper inner wall section 433, preferably have a wall thickness between 0.05 mm and 0.5 mm, and more preferably between 0.1 mm and 0.2 mm.

[0211] The section 731 between the nasal locators preferably has a thickness of 2 mm to 0.5 mm and preferably between 0.8 and 1 mm.

[0212] The specified dimensions are relevant for a silicone material with a Shore A hardness of approximately 40. If the seal is made of other materials, corresponding adjustments to the dimensions may be necessary, while maintaining the flexibility of the shell in areas requiring flexibility and sufficient stiffness to impart shape to the shell in areas where it needs to conform.

[0213] Fig. 8 is a section through DD of the mask seal and the body made of Fig. 7A. This shows the cross-section of the middle section of the seal on the outside as with reference to Fig. Figure 7D shows and has already been described, but it illustrates the connection between the sealing opening and the opening of the mask body. The section in Fig. Figure 8 also shows a preferred cross-sectional shape of a nasal locator. In particular, the thickness of the material of the wall 806 of the nasal locator is preferably between 0.5 mm and 2 mm, and more preferably between 0.8 mm and 1 mm.

[0214] The nasal locator has a base section 808 and a nozzle section 810 with a central opening 812. The section with the opening 812 fits into the user's nostril. The base section 808 provides primary localization at the entrance to the nostril. Fig. 9A is a section through line GG of the seal made of Fig. 7D. This is a cross-section of the seal approximately on the horizontal median plane through the nose locators. This section shows that the wall sections 806 of the nose locators, the immediately adjacent region 902 outside the perimeter of the nose locators, and the central section 731 between the nose locators all have a thickened wall relative to the flexible wall sections 415 and 423 of the side sections of the seal. In particular, the regions immediately adjacent to and enclosing the nose locators preferably have a thickness between 0.5 mm and 2 mm, and more preferably between 0.8 mm and 1 mm.

[0215] The outer wall sections 413 of the side sections of the seal are significantly thicker than the sections adjacent to the nose locators. These sections preferably have a thickness between 2 mm and 5 mm, and particularly preferably between 3 mm and 5 mm. The thickness of these sections gradually decreases and reaches the flexible thickness at the point where they become the circumferential section 423.

[0216] The thickened section of the outer side wall 413 of the side sections preferably extends to approximately 10 mm from the outermost tip of the side section.

[0217] The thickening and stiffness of these outer side sections 413 essentially give the seal its shape and stability when the seal is in place. The side wall resists outward bending of the side section of the seal when the seal is inflated under the pressure of the feed, while the wall sections 413 bend outward under pressure and have sufficient reaction force to keep the seal wrapped around the nose of the carrier.

[0218] The stiffening produced by the thicker regions of the seal could be provided by a composite material or a combination of components. For example, the stiffness could be achieved through reinforcement within the silicone or by a flexible insert made of rigid material. The rigid insert could be integrated into the mask body. Preferably, the design is such that the side sections of the seal, with an effective stiffness of at least 1 N at the end of the stiffened region, resist bending, allowing the side section to bend at an angle of approximately 60°.

[0219] Fig. Figure 9B shows another, essentially horizontal plane above the cross-section. Fig. 9A. This cross-section runs through line FF in Fig. 7D. This again illustrates the thickness of the outer sidewall sections 413 of the side sections of the seal relative to the inner sidewall sections 415 and the perimeter sections 423 and relative to the thickness of the upper inner wall section 433.

[0220] The side sections 413 preferably have a thickness between 2 mm and 5 mm, and particularly preferably between 3 mm and 5 mm. The flexible sections 415, 423 and 433 have a thickness between 0.05 mm and 0.5 mm, and particularly preferably between 0.1 mm and 0.2 mm.

[0221] Fig. Figures 10A to 10C are perspective views of a patient interface that incorporates a number of inventions described in this patent specification. Fig. 10A is a front view, Fig. 10B is a profile view and Fig. 10C is a view from the rear.

[0222] The 1000 interface is similar to the one with reference to Fig. The interface described in sections 1 to 3. Seal 1010 shares many similarities with the seal from... Fig. 4. The frame arrangement 1008 has some of the same features as the frame 303 from Fig. 5. How the interface is formed Fig. Interfaces 1 to 3 of 1000 have a short hanging cable that is connected to the frame assembly 1008 via a ball joint or swivel connection. This is similar to the interface from Fig. 1 to 3, the interface is preferably attached to the wearer's head via a strap with a single loop. This loop strap can be made of the materials described in this patent specification. The frame arrangement can incorporate lip stabilizers as described in reference to Fig. 58 to 61 are described.

[0223] With reference to Fig. In versions 10A to 10C, the interface 1000 has an overall configuration comprising a frame assembly 1008 and a seal 1010 on the inside of the frame assembly. A supply line 1004 hangs down from the frame assembly and supplies gases to the frame assembly and thus also to the seal. The head mounting part 1002 is connected to the frame assembly to attach the interface to the user's head.

[0224] The frame arrangement has 1016 side sections. As the arrangement consists of Fig. 5. The side sections can extend away from the outer wall of the seal (and thus from the face of the carrier in use). At least one, and preferably both, side sections 1016 provide for the connection of a connector 1014 to the head mounting part 1002.

[0225] The connector 1014 is connected such that it terminates at one end of the belt 1012. Preferably, each end of the belt 1012 has a connector and each side section 1016 has a matching interacting connection.

[0226] The feeder preferably has a short flexible hose 1016, a feed connector 1022 and an interface connector 1006.

[0227] Hose 1026 can have many forms. For example, hose 1026 can be an expandable tube, a resilient tube that is typically short in its relaxed state, an extruded corrugated tube, or a wound ribbon tube with a helical rib. The tube should be resistant to crushing and allow for extensive lateral twisting and bending. The tube is preferably between 50 mm and 150 mm long.

[0228] The interface connector may have a bias flow vent. However, no bias flow vent is provided on the connector in the interface shown. The connector 1006 preferably has sections of a swivel joint 1020 with the frame assembly 1008. The connector preferably has a section of a ball joint or swivel joint and, more preferably, an extended hollow plug section that extends into a bushing of the frame assembly.

[0229] With reference to Fig. 10B, the connector preferably redirects the supply flow through an angle between 25 degrees and 75 degrees. Particularly preferably, the connector redirects the flow through an angle between 40 degrees and 60 degrees. This angle coincides with the angle of the front of the frame assembly in the immediate vicinity of the joint 1020 (for example, relative to the frontal plane of the user), so that the tube 1026 hangs slightly below the interface (when the user is standing), remains close to the user when the user is lying down, and keeps the joint 1020 close to the patient.

[0230] The feed connector 1022 preferably has a pivot point.

[0231] The frame arrangement 1008 preferably includes a bias flow vent 1018. The bias flow vent 1018 can have at least one flow path from the interior of the interface to the environment. An interface can be provided for use with a backflow ventilator without a bias flow vent.

[0232] If a bias flow vent is included, the bias flow vent may have at least one opening extending through the wall defining the frame arrangement. In the interface shown, the bias flow vent 1018 has a plurality of openings. The openings are arranged such that they direct the exhaust flow of gases predominantly upwards relative to the head of the wearer. Predominantly upwards means that the gases are directed in a direction more parallel to the plane of the face (or frontal plane) than perpendicular to the plane of the face, and generally towards the forehead.

[0233] How best to Fig. As can be seen in 10C, the frame arrangement can have hanging support sections 1024 extending below the seal 1010.

[0234] The hanging support sections feature 1030 pads that serve as support on the upper lip area of ​​the wearer near the nasolabial folds. In some users, the 1030 pads may extend to the lower cheek area immediately adjacent to the nasolabial folds. The pads should only come into contact with the face when the seal requires support. This aspect of the interface is described in more detail with reference to Fig. Described in sections 18 to 61.

[0235] In Fig. 10C further comprises a pair of nasal locators 1036. Each nasal locator has an opening which, in use, is positioned in one nostril of the wearer. The nasal locators extend from a flexible inner wall section 1042 of the seal.

[0236] In the interface shown, each nose locator has a generally tubular nozzle section 1040 and a convex base section 1038. The generally tubular nozzle section 1040 may be slightly tapered towards the open end. The convex base section can be considered dome-shaped.

[0237] In some embodiments, the convex base section extends all the way around the locator and surrounds the tubular nozzle section. In other embodiments, the convex base section may extend around most, but not completely, of the locator. For example, the base section may extend continuously around 60% or more of the locator.

[0238] Both the nozzle section and the base sections of each locator preferably have an oval or elliptical cross-section. This is described in more detail in Fig. Shown from 11E to 11H.

[0239] Fig. 11A to 11H are views of the soft sealing component of the interface. Fig. 10A to 10C. Fig. 11A is a top view. Fig. 11B is a front view. Fig. 11C is a rear view from a position pointing directly towards the open end of a nasal locator. Fig. 11D is a cross-section through section CC in Fig. 11C.

[0240] These figures bear many similarities to the poetry from Fig. 4. The benefits and function of the similar features are not repeated in detail.

[0241] Generally speaking, the seal has an inward-facing wall section and an outward-facing wall section. The inward-facing wall section forms the seal against the face surfaces of the support. The outward-facing wall section connects the seal to the frame assembly and supports the overall shape of the seal. How the seal is made of Fig. 4 The general shape of the seal is U- or V-shaped, with the side sections extending to the rear from a central transverse part.

[0242] The outward-facing section has side sections 1032 that have a larger cross-section than the inward-facing wall. The inward-facing wall has nose locators supported on a generally flexible background 1052. A compliant perimeter 1034, 1044 connects the outward-facing wall to the inward-facing wall around the perimeter.

[0243] With particular reference to Fig. 11A and Fig. 11D Each nasal locator preferably comprises a tubular section 1042 and a dome section 1038. Furthermore, each tubular section terminates in a rim 1042 that defines an opening 1050.

[0244] The tubular section tapers towards the opening 1050. The taper is preferably linear. Alternatively, the taper can be curved. The surfaces of the dome section and the tubular section meet at an obtuse angle, for example, between 120 degrees and 160 degrees.

[0245] The cross-section of Fig. 11D indicates that the tubular section 1042 is approximately frustoconical, while the domed section 1038 is approximately truncated spheroid. In each case, the cross-section ( Fig. 11F to 11H) but oval and not circular. Therefore, the shape of the dome can be considered ellipsoidal. The shape of the tubular section can be considered an elliptical cone. In any case, the shape need not be a true ellipse; instead, it may include less regular oval shapes. For example, the shape of the dome may be an ovaloid or an ovaloid dome, and the shape of the tube may be egg-shaped, an ovaloid cone, a tapered egg shape, or an ovaloid tube.

[0246] The tubular sections of the nasal locators are spaced apart but oriented such that their axes generally converge. Preferably, the convergent distance is between 10 mm and 40 mm from the openings of the nasal locators.

[0247] The dome sections of the nose locators come close together, approximately at a slit 1046 on or adjacent to the center line of the seal. Preferably, the slit 1046 should allow some freedom of movement for the dome on one nose locator relative to the dome on the other nose locator.

[0248] Especially with regard to Fig. Figures 11E to 11H show the oval cross-section of each nasal locator in more detail. In particular, three cross-sections of the nasal locator are shown. These cross-sections are taken from planes parallel to the plane of the opening of the open end of the nasal locator.

[0249] These cross-sections show the oval shape. In particular, the oval or ellipse of the aperture 1050 has an aspect ratio of approximately 1.8 to 1. The major axis of the oval or ellipse is more than twice the size of the minor axis and preferably between 1.5 and 3 times the size of the minor axis.

[0250] The oval shape is maintained throughout the entire tubular section and the domed sections of the nose locator. However, in the gasket shown, the absolute difference between the main and secondary axes is preserved instead of the ratio. Therefore, the ratio decreases from the shape of the opening 1050 to the first cross-section 1054 with increasing distance from the bottom of the tubular section. The ratio decreases further from cross-section 1054 to cross-section 1056 at an intermediate position on the domed section. The ratio decreases further from cross-section 1056 to cross-section 1058 at the bottom of the domed section.

[0251] For example, the dimension of the main axis for the tip opening can be approximately 9 mm and that of the secondary axis approximately 5 mm. For the cross-section of the tubular section at EE, the dimension of the main axis can be approximately 13 mm and that of the secondary axis approximately 9 mm.

[0252] The dimension of the main axis for the dome section can be approximately 18 mm and that of the secondary axis approximately 15 mm.

[0253] The dimension of the main axis for the dome section at HH can be approximately 22 mm and that of the secondary axis approximately 18 mm.

[0254] How best to Fig. As can be seen in Figure 10C, the oval shapes of the nasal locators are preferably not aligned parallel when viewed from the back of the interface. In particular, the upper ends of the ovals are closer together than the lower ends. When projected posteriorly onto the frontal plane of a hypothetical patient, the principal axes of the ovals form an angle between 60 and 120 degrees.

[0255] Each nasal locator is preferably provided with a lip 1042 at the open end 1050. The material on the lip 1042 is preferably thicker than the material of the remaining tubular section or than the material in the region of the tubular section near the lip. The thickened lip gives the end of the nasal locator a slightly positive shape when the locator is positioned in the wearer's nostril. This can be useful for the wearer because they can better feel the end of the locator when applying the interface.

[0256] Fig. 11B and Fig. Figure 11E also shows features of the seal in connection with the attachment of the seal to the frame assembly. As in Fig. As can be seen in Figure 11B, the outward-facing section of the seal has a main opening for attaching the frame assembly. The main opening has a lip 1048 that extends around the circumference of the opening. The lip can be represented by the thicker regions of the outer wall of the seal. For example, the lower section of the lip is shown in cross-section in Figure 11B. Fig. 11E shown.

[0257] Markings or features for correct seal alignment relative to the frame can be provided at one or more locations on the lip. The seal shown and described is sensitive to incorrect alignment. In this embodiment, the seal is positioned so that it can be removed from the frame.

[0258] For easier positioning, the lip is preferably provided with a projection that engages in a notch in the frame when the seal is in the correct position. The lip can be provided with a projection 1046 that extends inwards, outwards, or in both directions. In the embodiment shown, two projections 1046 are provided that engage in notches 1074 and 1092 of the frame.

[0259] The sealing lip has the overall shape of a curved oval. This means an oval that has been bent so that the ends of the oval are curved away from a plane tangentially to the central sections of the oval. This can generally be described as the shape of the outer wall section of the seal. Fig. It can be seen at 11A.

[0260] Fig. 12A to 12H are views of a frame arrangement of the interface. Fig. 10A to 10C. Fig. Figure 12A is a perspective front view of the frame arrangement. Fig. Figure 12B is a perspective rear view of the frame arrangement. Fig. 12C is a side profile of the frame arrangement. Fig. 12D is an assembled view of two components of the frame arrangement. Fig. Figure 12E is a rear view of the frame arrangement.

[0261] Fig. Figure 12I is a rear view of a frame assembly with a slightly different configuration, where the stabilizer sections are not shown. This shows an alternative configuration of the channel for securing the seal. The frame assembly can otherwise be constructed essentially the same as the frame assembly from Fig. 12A to 12H shaped and assembled.

[0262] The frame arrangement 1008 comprises two main components, a first component 1070 and a cover 1060.

[0263] The two components of the frame arrangement together form a channel 1096 for attaching the lip 1048 of the seal.

[0264] The first component 1070 can have a first section of the channel, while the cover 1060 provides a second section of the channel. Component 1070 can provide an inner flange section 1072, and the cover can provide an outer flange section 1094. A bottom section for the channel extending from the flange section of each part can be provided. For example, the bottom section 1088 can be provided from the flange section 1072.

[0265] Flange section 1072 may have a notch 1074 for receiving a locator for the lip 1048 of the gasket. Flange section 1094 may have a notch 1092 for receiving an additional locator for the lip of the gasket.

[0266] In a preferred form of the seal and channel, the channel is generally flared outwards, such that sections of the channel on opposite sides of the main opening diverge relative to each other from the bottom of the channel to the open edge of the channel. Accordingly, the sealing lip extends over the inner flange section 1072, and the seal is maintained in the channel by the elastic tension of the lip.

[0267] In the framework arrangement from Fig. From 12A to 12H, the channel forms a generally curved ellipse. In the example from Fig. 12I The channel follows a path that more closely resembles a curved rectangle or trapezoid. In particular, the overall path of the channel is not as wide as the path of the channel in the embodiment of Fig. 12A to 12H. Furthermore, the channel has relatively straight side sections 1220. The side sections 1220 converge slightly towards the lower section 1226 and diverge slightly towards the upper section 1217. While this arrangement as a whole maintains the curved oval shape, the straight side sections improve the assembly compared to the sharply curved end sections of the curved ellipse. Fig. 12A to 12H.

[0268] The alignment of notches and projections preferably takes place next to the upper or lower section of the channel, particularly next to the upper channel section. This allows the lip 1048 to be positioned correctly in the channel, and the remainder of the lip can then be stretched over the inner flange section 1072.

[0269] The first component 1070 may have extensions for carrying the support pads 1030. For example, a lower shield section may extend in a curve below the feed opening of the interface. The lower shield section may have side sections. Pads 1030 are provided on the lower inner side of the side sections.

[0270] An inner surface 1078 of an upper section of the shield can be wrapped around the sides of the cut stele and is located outside and adjacent to the outer wall of the seal. The upper sections of the shield can help maintain the shape of the seal under internal gas pressures by limiting outward deflection of the outer surface of the seal sheath.

[0271] The first component can carry part of the swivel connection 1020. Preferably, the first component 1070 has a ring section 1080 that is open at the front and rear. The ring section preferably has surfaces for engaging with surfaces of the connector of the supply hose.

[0272] Preferably, the annular section 1080 has an inwardly facing, substantially spherical surface 1084. The inwardly facing surface 1084 can engage with an outwardly facing complementary wall of a spherical section of the connector of the supply hose. The spherical section of the connector of the supply hose can have an internal passage that guides gases from the supply hose through the annular section 1080.

[0273] One advantage of this arrangement is the improved material selection. The connector of the feed hose is preferably made of a different base polymer material than the ring section 1080 of component 1070. Different polymer materials working against each other tend to exhibit lower friction and noise than polymers of the same base material. The outer cover 1060, however, can be made of the same material as the connector of the feed hose, thus providing an aesthetically pleasing appearance.

[0274] For example, the ring section of component 1070 may be molded from a material chosen for its strength and toughness, such as a polycarbonate plastic, while the cover 1060 and the connector of the feed hose may be molded from a plastic chosen primarily for its surface finish and appearance, such as an acetal plastic. The acetal plastic may contain a low-friction copolymer such as PTFE (polytetrafluoroethylene).

[0275] The ring section 1080 may also have features for fastening the two components 1060 and 1070.

[0276] For example, the outer surface of the ring section 1080 may be provided with outwardly facing features such as depressions or a channel 1082 to cooperate with inwardly facing clamps or an inwardly facing annular ridge 1087 of the circumference 1066 of the opening 1068 of the cover 1060. This is best illustrated in the cross-section of Fig. 12G can be seen.

[0277] The outer perimeter of cover 1060 can merge into the surfaces of component 1070 in some areas. For example, the lower curved edge of cover 1060 can abut the upper curved edge of the lower shield of component 1070. This is in Fig. 12G is shown at 1081. A similarly abutting edge on the side sections is shown at 1081 in Fig. Shown at 12H.

[0278] Components 1060 and 1070 can form an outlet dry chamber adjacent to the bias flow vent 1018. This is best seen in the expanded view in Fig. 12D and the rear view in Fig. 12B and the cross-sections in Fig. 12G and Fig. To understand 12H. The drying chamber 1079 is defined between a curved oval frame section 1072, the component 1070 and the inside of the cover 1060 near the opening 1068.

[0279] Openings 1086 in the drying chamber 1079 are defined by the rear edge of the ring section 1080 and by the oval frame section 1073. Gases flowing from the seal to the bias flow vent pass through these openings. The inner surface 1098 of the flange 1072 of the oval frame 1073 preferably converges towards the plenum and defines a flow-directing surface, such as a funnel.

[0280] The holes of the bias flow vent 1018 lead away from the drying chamber 1079.

[0281] The ring section 1080 opens essentially centrally through the oval frame section 1073. This divides the flow into the seal and the outflow of the seal essentially at one point directly next to the open end of the seal.

[0282] The ring section can be supported in this position by one or more support struts 1076 or by regions on the top and bottom where the ring and oval frame section meet.

[0283] The bias flow holes 1097 are arranged in an arc around the upper section 1089 of the drying chamber 1079. This upper section is located in the Fig. The area shown in 12G is quite limited, immediately above ring section 1080, but more open on each side.

[0284] For an upward directed output flow (generally parallel to the frontal plane of the carrier), the bias flow holes can be arranged in a rib section 1099 of the wall of the cover 1060.

[0285] The lower shield section of component 1060 may have a soft cover 1085, for example, a sheathed layer of a soft biocompatible material, or a more rigid skeleton or frame 1083. A preferred cover would be, for example, a thermoplastic elastomer, a polyurethane foam, or a silicone elastomer. The skeleton or frame 1083 of component 1060 may be formed from a copolymer containing an amount of a plastic material that bonds strongly with the cover material. For example, the frame 1083 may be formed from a polycarbonate-siloxane copolymer. The siloxane contributes its chemical resistance and improves the bond of the sheathed silicone cover.

[0286] Extreme side sections 1016 of the cover 1060 diverge from the outer sides of the shield of component 1070. The side sections 1016 terminate in sockets 1062 for receiving connectors of the strap of the head mounting part.

[0287] Fig. Figures 13 to 20 show another embodiment of an interface with a wrap around the inflatable seal. The interface 1100 has a sealing body 1101 and a frame 1102.

[0288] A hose 1112 is attached to the frame 1102, which in turn is attached to a gas supply device. The hose supplies gas to the mask frame and the seal. The hose 1112 can be secured to the user (who wears the interface 1100) with a strap 1113. In use, the strap 1113 extends around the user's neck. The strap 1113 is attached to the hose using known methods, but the drawing shows a C-shaped clamp 1114, which is attached to the strap 1113 and clamped around the hose.

[0289] The interface 1100 is held over the user's nose by a head strap 1114. The strap is preferably made of a flexible material, such as silicone or a laminated material, which is well known in the prior art of head straps. Each end of the strap 1114 is preferably provided with a clip 1116, which is attached to a corresponding eyelet 1117 that is formed in or attached to the sealing body 1101. The strap can be a flat silicone strap, a small hollow silicone tube, or a corresponding configuration known in the prior art.

[0290] The frame 1102 can have a variety of holes 1115 for the crossflow of breathing gases (bias flow) so that the user's exhaled gases can be vented from the interface. Alternatively, bias flow holes can be formed in the sealing body 1101 to vent gases.

[0291] The sealing body 1101 is flexible or inflatable. The sealing body 1101 has a curved shape to conform to the contours of a human face and extends around the user's nose, wrapping around it. The sealing body 1101 preferably extends completely over the user's nostrils and may also extend partially over the user's cheeks. The seal 1101 comprises an inner wall 1103 and an outer wall 1104. Nose locators 1105 and 1106, each with openings 1107 and 1108, protrude from the inner wall 1103.

[0292] As in the embodiment of Fig. From 10 to 12, the sealing body 1101 has an inlet opening 1109 which is opposite the nose locators 1105, 1106 and accommodates the frame 1102.

[0293] The seal 1101 has a variable wall thickness, resulting in rigidity around the protruding sections of the seal and flexibility between the nasal locators 1105, 1106 and the circumference 1110 of the inlet opening 1109. This creates a decoupling effect between the nasal locators 1105, 1106 and the inlet circumference 1110, and subsequently the mask frame 1102. This allows for some movement of the mask frame without disrupting the seal of the nasal locators 1105, 1106 on or in the user's nostrils.

[0294] As in Fig. As can be seen in Figure 18, the inlet circumference 1110, which defines the gas inlet 1105 for sealing, has a substantially thick cross-section. This ensures that the inlet circumference 1110 is rigid. Similarly, the nose locators 1105 and 1106 have a thick cross-section. However, the thickness of the nose locators need not necessarily be as thick as or thicker than the inlet circumference 1110. In the preferred embodiment, the thickness of the nose locators is less than that of the inlet circumference.

[0295] The areas between the inlet circumference 1110 and the nasal locators 1105, 1106 preferably have a thinner cross-section than the nasal locators and the inlet circumference. Fig. For example, the length of the seal 1101 between X and Y is significantly thinner in cross-section than the inlet circumference or the nasal locators. This means that this length is more flexible and effectively allows greater movement of the nasal locators 1105, 1106. Furthermore, because the length between X and Y, including an outer circumference 1111, has a thinner cross-section, the seal can be easily inflated so that it can more easily form a tight seal around the user's nose.

[0296] As in Fig. As shown in Figure 18, a region 1118 of the sheath next to the base or root of each nasal locator preferably has a thickened cross-section. As shown, the length or region 1119 of the seal between region 1118 and the thickened inlet circumference 1110 is preferably significantly thinner in cross-section than the inlet circumference 1110, the nasal locators 1105, 1106, or region 1118. In an alternative embodiment, the sheath has a thickened region 1118 adjacent to the base of the nasal locators, and the thickness of the nasal locators' cross-section is not increased. For example, the thickness of the nasal locators' cross-section can be similar to the thickness of the sheath region 1119 between region 1118 adjacent to the nasal locators and the inlet circumference 1110. The thickened region 1118 adjacent to the base of the nasal locators prevents the base of the nasal locators from deforming or ballooning under typical CPAP pressures. However, the thinner wall of the nasal locators 1105, 1106 in this embodiment can balloon under CPAP pressure.

[0297] Preferably, the seal 1101 is made of silicone with a Shore A hardness of approximately 40. Alternatively, other materials with similar properties may be used. For silicone with a Shore A hardness of 40 or another material with similar properties, the thickness of the shell region 1119 between the nose locators and the inlet circumference is less than approximately 0.5 mm. Preferably, the region 1119 has a thickness of 0.1 mm to 0.2 mm. Alternatively, this region 1119 of the shell may have a thickness of less than 0.1 mm, for example, 0.05 mm.

[0298] The thickness of region 1118 adjacent to the base of the nasal locators is preferably less than 2 mm. Preferably, the thickness of region 1118 adjacent to the base of the nasal locators is approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of region 1118 adjacent to the base of the nasal locators is less than 0.8 mm, for example, 0.5 mm.

[0299] The thickness of the region next to the inlet circumference is approximately 3 mm to 5 mm, but it could also be thinner, for example 2 mm.

[0300] The nasal locators have a thickness of less than 2 mm. In the preferred embodiment, the nasal locators have a thickness of approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of the nasal locators can be less than 0.8 mm, for example, 0.5 mm.

[0301] In the alternative embodiment described above, the thickness of the nasal locators is similar to the thickness of the sheath region 1119 between the nasal locators and the inlet circumference. In this embodiment, the nasal locators have a preferred thickness of approximately 0.1 mm to 0.2 mm. Alternatively, the thickness of the nasal locators can be less than 0.2 mm, for example, 0.05 mm.

[0302] Preferably, the thickness changes gradually from one region of the seal to another. For example, the thickness of the seal changes gradually from the thickened section 1118 to the thinner section 1119.

[0303] Similarly, the thickness of the seal changes gradually from the thickened section 1110 to the thinner section 1119.

[0304] Referring to Fig. 20, which the seal 1101 in cross-section through AA from Fig. Figure 16 shows an alternative view of the seal 1101 with the different thicknesses of the seal components. In particular, the inlet circumference 1110 and the nose locators 1106, 1108 have a thicker cross-section compared to the outer circumference 1111. At least in the lateral direction, the thickened region 1110 extends beside the inlet for at least half the distance from the inlet to the outer circumferential edge 1121. In the upward direction, the thickened region extends for at least half the distance from the inlet to the upper circumferential edge 1123. In the downward direction, the thickened region extends for at least half the distance to a lower end section 1125. The areas of the seal between the nose locators 1106, 1107, generally shown as 1112, also have a thicker cross-section to provide additional stability for the nose locators in these areas.

[0305] In Fig. Figure 21 shows an alternative embodiment of the seal. In this alternative embodiment, the areas between the nose locators, designated 1113, have a significantly thinner cross-section than the inlet circumference 1110 and the nose locators 1106, 1108. This configuration would provide additional flexibility between the nose locators 1106, 1108.

[0306] Another embodiment of a seal according to the invention is in Fig. Figure 22 shows that the seal is inflatable, but it extends downwards to cover the user's mouth during use. This seal 1200 has nose locators 1201, 1202 and is mounted in a similar frame to one of the embodiments described in detail above. The seal 1200 has an extension 1203 that extends over the user's mouth, creating a seal and reducing mouth leakage.

[0307] Another embodiment of the seal according to the invention is in Fig. 23 shown. This seal 1300 has the same shape as the one in Fig. 22, with nasal locators 1301, 1302 and an extension 1203 to cover the mouth, but it also has an outlet 1304 directed towards the mouth of the user, through which gases can be simultaneously directed to the mouth of the user and the nasal passages of the user can be guided through the nasal locators 1301, 1302.

[0308] Fig. Figures 24 to 29 show various head straps that could be used with each embodiment of the interfaces described herein.

[0309] Fig. Figure 24 shows a single head strap 1402 which is attached to the interface 1400 by any suitable means known in the prior art of interfaces and head straps, in particular to the flexible and inflatable seal 1401. The strap 1402 can be a hollow tube 1402 as shown in Fig. 24a shown or a massive hose 1402' as in Fig. 24b. The hollow tube could, for example, be an extended silicone tube with a diameter between 3 mm and 6 mm and a wall thickness of 0.2 mm to 1 mm.

[0310] Fig. Figure 25 shows a single head strap 1410 which is attached to the interface 1400 by any suitable means known in the prior art of interfaces and head straps, in particular to the flexible and inflatable seal 1401. The strap 1410 can be a hollow elongated tube 1410 as shown in Fig. 25a shown or a massive hose 1410' as in Fig. 25b. The belt is preferably narrower at its ends 1411, 1412, which are attached to the seal 1401, and wider at its midpoint, which in use sits on the back of the user's head.

[0311] Fig. Figure 26 shows a double head strap 1420 attached to the interface 1400. The strap 1420 extends around the user's ears and has two attachment points on each side of the seal 1401, where the strap is attached to the seal 1401.

[0312] Fig. 27 and Fig. Figure 27a shows an extendable head strap 1430 attached to the interface 1400. The strap 1430 has a section 1431 that can be stretched and contracted to better fit the user's head.

[0313] Fig. Figure 28 shows an alternative head strap 1440 attached to the interface 1400, particularly to the seal 1401. The head strap 1440 preferably has side straps 1441 with rigid sections 1442, 1443 to provide additional stability to the side straps 1441. The head strap 1440 further preferably has an upper strap 1444 and a posterior strap 1445 extending over the head and behind the head, respectively. This head strap is described in more detail in US Patent Application No. 12 / 307993 by Fisher and Paykel Healthcare, the contents of which are hereby incorporated by reference.

[0314] Fig. 29 and Fig. Figure 29a shows another alternative head strap 1450, which is attached to the interface 1400, in particular to the seal 1401. The head strap 1450 is curved and has subdivisions 1451 which provide additional support to the strap or give it additional rigidity.

[0315] The head straps described above can be made of any suitable material, such as flexible plastic, silicone, laminated fabric, or other suitable materials.

[0316] Fig. Figures 30 to 33 show various ways of attaching an interface frame to an inflatable sealing body. Fig. 30 The sealing body 1500 has overmolded or bonded rigid plastic barbs 1502. The barbs 1502 are clamped in correspondingly shaped recesses 1503 in the frame 1501 and hold the sealing body 1500 in a sealing engagement with the frame 1501.

[0317] Similarly, in Fig. 31 The sealing body 1500 has a circumference 1512 formed with an overmolded or bonded rigid loop clamp 1513 made of plastic, which is clamped to the frame 1501. Further details of such a clamping mechanism are described in US patent application number 12 / 502528 by Fisher and Paykel Healthcare, the contents of which are hereby incorporated by reference.

[0318] As in Fig. As shown in Figure 32, the sealing body 1500 can alternatively have an inlet 1522 which is stretchably pressed around the frame 1501. The frame preferably has a notch 1523 and a raised edge 1524 which allows the inlet 1522 to engage in the frame.

[0319] In another alternative embodiment as in Fig. Figure 33 shows that a sealing body 1500 can be permanently attached to the frame 1501 by overmolding or bonding.

[0320] Fig. Figures 34 to 40 show different ways of attaching the hose extending from interface 1100 (1112, see Fig. 13) on a user. Fixing the hose to the user has the advantage of keeping the weight of the hose away from the interface, thereby reducing the risk of the interface being pulled down from the user's face. The supports described below are preferably formed from fabric straps. Preferably, the fabric is breathable, but other suitable fabrics may also be used. In all embodiments described in detail herein, the hose is attached to the support with a clamp or a pin.

[0321] In Fig. Figure 34 shows a support 1600 made from a fabric strap laid in loops, which in use is placed around the user's head and around one shoulder.

[0322] In Fig. Figure 35 shows an alternative support 1610. This support also preferably consists of fabric which is placed in a central cross over the user's chest and wrapped around each of the user's arms.

[0323] In Fig. Figure 36 shows another alternative support 1620. Here, the support 1620 has a central strap cross over the user's chest, but it is routed over the user's neck and back.

[0324] As in Fig. As shown in Figure 37, an alternative support 1630 could be used to fix the hose to the user, whereby a support is formed from the strap laid in loops, which is stretched over the user's chest and under his arms.

[0325] As in Fig. 38 or Fig. As shown in Figure 39, a support 1640 can additionally have two shoulder straps 1641, 1642 or simply one shoulder strap 1643.

[0326] As in Fig. Figure 40 shows that a simple support 1650 can be used with the interface according to the invention, which in use simply fits around the shoulder or upper arm of the user.

[0327] Additional hose support arrangements are provided with reference to Fig. Described in sections 41 to 57. Fig. 41 to 51 describe a support collar to be worn around the user's neck, to which the hose is attached with a tensioning rope. Fig. Paragraphs 52 to 55 describe aspects of a tensioning rope that can be used with such a collar or that could be used with other arrangements for fixing one end of the tensioning rope to the patient. Fig. 56 and Fig. Figure 57 shows two such arrangements for fixing a tension cable to the patient. Fig. Figures 34 to 40 show other arrangements for fixing such a tensioning rope to the patient.

[0328] Fig. Figures 41 to 45 show the collar in more detail, which was previously described roughly in relation to Fig. The collar is described in sections 1 to 3. It features an adjustable connection 327 and a secondary connection 329. The adjustable connection acts between a first end of the collar 4100 and a second end 4102. The adjustable connection 327 allows the user to adjust the amount of overlap between the ends 4100 and 4102. Fig. Figures 41 to 45 show an adjustable connection 327 in the form of a dome-shaped fastening system. A fastening section 4104 is attached to the first strap end 4100. A number of complementary fastening sections 4106 are spaced apart along the second strap end 4102. By engaging the fastening element 4104 with one of the series of fastening sections 4106, the overlap of the end 4100 relative to the end 4102 is determined. The fastening sections 4106 can be arranged at intervals of 2 cm to 5 cm, preferably 3 cm to 4 cm. This allows for some variation in the circumference of the collar in increments of 3 cm to 4 cm.

[0329] Preferably, the outer overlapping end 4100 has a single connecting section, and the inner end of the strap has a series of outwardly facing second connecting sections. According to this arrangement, no connecting section faces the patient's neck. Therefore, the inside of the collar is free of any interfering protrusions.

[0330] The connector sections can, for example, be sections of a dome-shaped fastening element of a known type.

[0331] The outermost end of the inner end 4102 may have an outward-facing loop that extends over the overlap section of the collar strap. This loop 4302, which is only in Fig. As shown in Figure 43, the free end of the overlap end 4102 would align with the overlap section of the collar if the collar is set to a smaller size.

[0332] Alternative connectors for the adjustable connection are available in Fig. shown on pages 46 to 49. The dome-shaped fortification is described in more detail in Fig. 46 shown.

[0333] An alternative fastening element with magnetic engagement is available in Fig. Figure 47 shows the outer end of the belt 4702 having an inwardly facing magnetic section 4704. The inner end of the belt 4706 has an outwardly facing magnetic section 4708. The inwardly facing magnetic section 4704 is preferably magnetized with a first, inwardly directed polarity. The outwardly facing magnetic section 4708 is preferably magnetized with a complementary, outwardly directed polarity. A series of outwardly facing magnets 4708 would be arranged at intervals along the outer surface of the inner belt section 4706.

[0334] The magnetic sections can be attached to a base section 4710, which in turn can be attached to the belt. The magnets can, for example, be glued to a substrate material that can then be sewn to the belt. Alternatively, magnets could be formed with holes so that they can be sewn directly to the belt.

[0335] Magnet 4704 could be replaced by a magnetic material that would be attracted to magnets 4708 but is not itself a magnet. Alternatively, magnets 4708 could be replaced by sections of a material that is magnetic but not itself a magnet. For example, the magnets could be ferrite or rare earth elements, while the magnetic materials could be small sections of steel. Ferrite powder bonded with a flexible polymer could give the magnets flexibility while maintaining sufficient strength to secure the collar.

[0336] Fig. Figure 48 shows the adjustable connection using a hook and loop fastening system (hook and loop fastener). For example, the outer end section 4802 can have a short section 4804 made of a material with protruding hooks. The inner strap end 4806 can have an outwardly projecting section 4808 covered with loops into which the hooks can engage and from which they can disengage. A suitable hook and loop fastener material is sold under the brand name Velcro.

[0337] The outward-facing loop material can be sewn to the collar strap, or the collar strap can be formed from a material with integrated loops. The length of the loop section 4808 is much greater than the length of the hook section 4804 and preferably extends over a distance corresponding to the required adjustability of the collar. For example, the loop fastening material could extend approximately 15 cm beyond the collar strap.

[0338] Fig. Figure 49 shows an alternative mechanical fastening element, similar to the dome-shaped fastening element. This type of dome-shaped fastening element has a smaller receiving opening 4902 on the female part and smaller projecting pins 4904 on the male part.

[0339] Referring to Fig. 43 to 45, the collar preferably has a second detachable connection 329 between a third end 4302 and a fourth end 4304. Thus, the entire ring of the collar is divided into two separate strap sections. Each strap section has a portion of the adjustable connections 327 at one end and a portion of the second connection 329 at the other end.

[0340] Preferably, this second connection is not adjustable. This second connection 329 can be engaged and disengaged each time the collar is used. The adjustable connection can be set to the correct length, and the second connection 329 can be used to secure and release the collar.

[0341] This second compound 329 can be formed from any suitable means, including those in Fig. Examples shown in 46 to 49, or a simple releasable fastening clip as in Fig. 50A and Fig. 50B shown (50A in the connected state and 50B in the open state) or have a connector that releases when voltage is applied in a predetermined area.

[0342] The in Fig. The connection 329 shown in Figure 45 comprises a connector with a first body section 4502, which is attached to the belt end 4302, and a second body section 4504, which is attached to the fourth belt end 4304. The first and second body sections each have a projecting mandrel and a socket. The projecting mandrel of one body is complementary to the socket of the other body. The projecting mandrel and the socket preferably have an interference fit. The degree of interference fit and the force required to pull the mandrel out of the socket define the release force for the breakaway clamp.

[0343] This preferred breakaway clamp is described in more detail in Fig. 51A and Fig. 51B shown. In Fig. Figure 51A shows the clamp in the open configuration, in which the mandrel 5102 projects from each clamp body section, and each mandrel 5102 has a small lateral projection 5104. The bushing in each body section of the clamp has a lateral opening 5106. When the mandrel 5102 is pressed into the bushing, the projection 5104 extends into the opening 5106. The interference fit is provided by the engagement of the projection 5104 in the opening 5106. This connector is shown in the engaged state in Fig. 51B shown.

[0344] Referring to Fig. From 41 to 45, a tension cable extends from the collar. The tension cable 4112 is connected at one end to the collar and at its free end to an insertion clamp 4114. The insertion clamp 4114 serves to connect to the supply line for the patient interface. The insertion clamp 4114 is in Fig. Figure 55 shows in more detail, where an enlarged view of the fitting with the sleeve of the line is shown. The preferred connector has an open ring that fits over a sleeve section of the sleeve and is held between a flange 5502 of the sleeve and a flange 5504 of a swivel line connected to the sleeve.

[0345] The preferred tension cable has a breakaway clamp at any point along its length between the connection to the collar and the cable connector. The connector can be used in conjunction with the one already mentioned in relation to Fig. 51A and Fig. exhibit the form described in 51B. This type of connector is in Fig. 52, Fig. 54A and Fig. 54B shown.

[0346] Alternatively, the connector can have a pivot bearing, so that the collar does not need to be correctly oriented relative to the cable before the patient interface is applied. In this case, the connector can have a socket section 5302 and a male section 5304, the male section 5304 being rotationally symmetrical. For example, the male section 5304 can have a protruding knob 5306 with an enlarged end 5308. The socket 5302 would have protruding sections or an annular protruding section around the inner circumference next to the open end. The socket 5302 may need to be made in two parts and then joined together to create this protruding lip or lips. The socket section 5302 can be open at its other end 5310, so that the connecting section 5302 can be formed in one piece.This end can accommodate the end of a strap section 5312 of the tensioning cable.

[0347] Alternatively, a swivel bearing can be located at a different point on the tension cable.

[0348] Preferably, the tensioning cable is formed with a sliding connector 5202 at one end for connection over the collar. The sliding connector 5202 preferably comprises a shaped loop with straight sections on both sides of the collar surface, which are connected to each other by transverse sections above and below the collar edge. The loop preferably fits moderately tightly on the collar so that, once positioned, it tends to remain in that position but can be moved over the collar when sufficient force is applied. The loop 5202 is essentially a mirror image of the profile of the collar surface. A tensioning cable section can extend from the loop 5202 and is preferably formed integrally with the loop 5202. Preferably, the tensioning cable section and the loop are formed from a flexible, compliant material such as silicone.

[0349] Another section of tension cable extends from the quick-release connector to the cable in the clamp. This section can be made of any suitable material, preferably flexible and preferably silicone.

[0350] The tensioning cord can have a fixed or adjustable length. Preferably, the tensioning cord can be available in several lengths so that the patient can make a choice. The tensioning cord can be between 3 cm and 15 cm long. A tensioning cord with a length of approximately 3 cm is in Fig. Figures 54A to 54B show the tensioning cable, which, if present at all, has only limited webbing sections. This tensioning cable consists primarily of the connection between its loop connector and the collar, the quick-release connector, and its connection to the cable connector.

[0351] A longer tension cable is in Fig. 52 and in Fig. Figure 53 shows a substantial strap section between the connecting loop 5202 and the quick-release connector, as well as another substantial strap section between the quick-release connector and the cable connector. These sections of the tension cable could be interchanged, so that, for example, the entire strap section of the tension cable could be located on one side or the other of the connector.

[0352] Fig. Figure 56 shows an alternative support arrangement for the use of the collar. The tensioning cable 5602 terminates in a clamp 5604 instead of a connector for the collar. The clamp 5604, which preferably has the form of a dowel, a crimp clamp, or another arrangement with gripping jaws, serves to fasten to the neckline or another comfortable part of the clothing worn by the patient. Alternatively, the tensioning cable can terminate in a connector for connection to support structures worn by the patient as previously described.

[0353] The tension cable may or may not have a connector.

[0354] Fig. Figure 57 shows another alternative for connecting to the clothing 5702 on the patient. This shows the sliding clamp 5704, which is connected to the neckline of the clothing and has a connector 5706.

[0355] The preferred collar is made of materials that are comfortable for the wearer. In its simplest form, the collar could be a strap made of a soft, flexible material with sufficient thickness to maintain the overall shape, sufficient strength to withstand significant stretching or elongation, and a comfortable inner surface facing the patient. A suitable material could be, for example, a laminated foam material such as Breathoprene, which has a foam core lined on both sides with a knitted fabric.

[0356] The preferred collar is more resistant to stretching and more breathable than Breathoprene. To ensure comfort against the skin, the collar is preferably lined with a woven, knitted, or braided fabric made of natural fibers. An example is a braided or knitted tube of cotton or bamboo yarn. To give the collar its shape, the braided or knitted tube surrounds a flexible frame. The flexible frame could comprise a series of hinged frames or a shaped flexible strap with an open frame. Preferably, it includes a narrow strap made of plastic mesh. An example of a suitable mesh is 3MESH from Mullter Texti Group in Germany. The open frame or mesh allows moisture and heat to pass easily through the collar, thus reducing patient discomfort during prolonged wear.

[0357] The collar strap is preferably 3 cm to 6 cm wide and 3 mm to 8 mm thick.

[0358] A preferred simple head strap is in Fig. Figures 1 to 3 show a single, unforked strap with a connector at each end. The strap could be permanently attached to both ends of the frame, but preferably the connectors can be detached from the mask body. Another example of a preferred head strap is shown in Fig. 10A to 10C shown and a preferred connecting clamp is in Fig. 63A to 63D shown.

[0359] The single, non-forked strap can preferably accommodate a considerable variation in head size without adjustment. The preferred strap exhibits very low stiffness, whereby an extension of 400 mm for a large strap from a fully extended but unstretched state to a state 1.3 times its original length requires a force of at most 4 N, and preferably at most 2 N. Fig. Figure 52 is a graphical representation of the force / extension properties of four exemplary webbing materials. The preferred material comprises a knitted or braided tube of nylon yarn with Lycra strands. The nylon yarn is sufficiently loosely formed to be stretched over the required area without becoming too tight. The number of Lycra strands in the yarn can be varied to change the stiffness of the webbing. The overall diameter or width of the webbing is preferably less than 10 mm and particularly preferably less than 6 mm.

[0360] The belt end connectors can be attached to the belt in any suitable manner. Preferably, the end connectors are formed by overmolding over the ends of the belts. Test results for a number of alternative belt materials are available in Fig. 62 shown.

[0361] All test results apply to extensions of the test material from a "rest" length up to approximately 400 mm.

[0362] Line 6202 shows the elongation test results for a knitted nylon yarn with Lycra threads, where the knitted tube has a nominal diameter of 5 mm. It is also stiffer than desired.

[0363] Line 6206 shows a hypothetical optimal desirable response determined by the inventors.

[0364] Line 6209 shows the response for an extended hollow silicone tube with a wall thickness of 0.25 mm and an outer diameter of 3 mm.

[0365] Line 6207 shows the response for an extended hollow silicone tube with a wall thickness of 0.25 mm and an outer diameter of 6 mm.

[0366] Both silicone expansions exhibit satisfactory properties.

[0367] Line 6205 shows the reaction of the preferred knitted nylon yarn with the Lycra threads. This knitted tube had a nominal diameter of 4 mm.

[0368] Line 6208 shows the reaction of a 3 mm length of woven elastic web. This product showed similar properties to the preferred knitted yarn, but the elastic web tended to catch hair and lose elasticity. HEADBAND

[0369] The most preferred headband incorporates a braided elastic band. Lengths of elastic thread are wound around a multitude of spools. The spools of thread are then used in a braiding machine to produce a continuous braided tube. The tube is passed over or between a roller or multiple rollers to flatten it into a band.

[0370] The preferred head strap has a cross-sectional dimension of approximately 6 mm width and 1.5 mm thickness.

[0371] In the most preferred embodiment, the thread comprises a strand of Lycra (elastane or spandex) with a spun sheath. The elastane strand can, for example, be a 900 denier Lycra strand (elastane or spandex).

[0372] The spun sheath can comprise at least one yarn made of nylon threads. The sheath can include a primary sheath yarn and a secondary sheath yarn. Each yarn can comprise a spun yarn made of a variety of nylon threads.

[0373] For example, each cover can contain a yarn made of nylon threads.

[0374] The nylon threads give the stretchable thread its color. For example, the nylon sheath for a white headband should contain white nylon fibers.

[0375] When manufacturing a spool from the stretchable thread, several threads (preferably three threads) from the stretchable thread are preferably wound parallel onto the spool, so that each element in the braiding process actually comprises a bundle of three parallel threads.

[0376] Preferably, the braiding process is carried out on a braiding machine with 16 bobbins, such as a Ratera 16 / 80 braiding machine from Talleres Ratera SA, Barcelona, ​​Spain. Each bobbin for the braiding process is prepared with three parallel threads as described above.

[0377] The braiding machine is configured (for example, by adjusting tensions, speeds, or both) to produce a suitable braid. Example settings for the Ratera 16 braiding machine speed control are A:45, B:20, C:30, and D:35.

[0378] A head strap manufactured according to this description was tested by gradual stretching, with the force recorded at each stretch. The force-versus-stretch results for a 300 mm long prototype strap material are presented in Fig. 64 shown. Fig. 63A and Fig. Reference 63C illustrates features of a preferred head attachment strap. In particular, it illustrates preferred arrangements for attaching a connector to one end of a suitable stretchable strap material. It also illustrates a preferred connector for joining the strap to the interface frame.

[0379] Fig. 63D to 63I illustrate another similar head restraint strap that shares many features with the head restraint strap from Fig. 63A to 63C. Unless otherwise stated, the following description refers to both embodiments with the same reference numerals.

[0380] At least one end of the belt 6304 terminates, and preferably both ends terminate, with a connector 6302. After assembly of the completed interface, the connectors 6302 engage in the side sections 1016 of the frame.

[0381] To form the connector, the flattened tube 6306 is encapsulated by the plastic body 6308 or 6350, for example by sheathing.

[0382] In the embodiment of Fig. In sizes 63D to 63J, the band is encapsulated in a comparatively soft material such as a thermoplastic elastomer.

[0383] The plastic body 6308 may have gripping features on its outer surfaces, such as protrusions or ridges 6324 or indentations 6352.

[0384] The body 6308 terminates at its other end in an end face, which preferably has a size and shape that corresponds to the end face of the side sections 1016. The connector and the receiving bushing are preferably formed from a rigid connection between the connector and the frame, such that when the connector engages, it forms a rigid extension of the side section of the frame. Thus, the connectors contribute to the frame with their length and define the point at which the flexible straps extend from the frame.

[0385] The preferred connection comprises a metal plug portion extending from the end face of the connector 6302 and engaging in the bushing 1062 formed in the end face of the frame. The plug portion, made of metal (preferably steel or titanium or a similar material), exhibits high stiffness and strength while maintaining a compact shape.

[0386] The graft part can advantageously be formed from a metal wire 6310. For example, the graft part can be formed from a single piece of stainless steel wire.

[0387] The wire can be bent backwards and both ends can be enclosed by connector 6302, the wire thus forming a loop that protrudes from the end face of the connector. To interact with this loop, the socket can be in the form of a slot, the overall shape of which corresponds to the substantially flat prong formed by the loop.

[0388] The loop can have a leg 6316 with a projecting bend or bump. The projecting bend 6322 can engage in a shallow notch 6334 in the bushing 1062. The notch 6334 can be formed along an edge surface of the slot.

[0389] The loop can be provided with a projecting end section 6318, which is located furthest from the connector 6302. The slot can be provided with edge surfaces that correspond exactly to at least the lateral profile of the end section 6318 in order to tightly accommodate the end section with the loop engaging in the slot. This secures the connector against rotation in the plane of the loop.

[0390] The thickness of the slot preferably corresponds as closely as possible to the thickness of the wire. This secures the connector against rotation perpendicular to the loop plane.

[0391] The loop can have a straight extremity 6320 and the slot can have a complementary straight end face. These straight faces provide a sliding reference surface for aligning the connector with the socket during and after engagement.

[0392] If one end of the wire loop is bent and the other is straight, and complementary surfaces are provided in the slot, the connectors can have shapes that ensure correct orientation of the connectors relative to the socket. For example, the connectors can have a shape that is an obvious continuation of the frame shape.

[0393] If a connector and a socket are provided at both ends of the belt, the connectors (and the sockets) may have a reversed orientation. For example, one socket may have a recess 6334 on the lower end face and the other socket may have the recess on the upper end face.

[0394] Alternatively, the connectors may have a shape or marking that ensures the correct selection of the intended socket and the orientation relative to the selected socket.

[0395] As in Fig. 63A and Fig. As can be seen in Figure 63C, one of the main extremities of the wire loop can move freely within a cavity 6314 of the connector body 6308. Preferably, the free end 6340 is the end of the extremity 6316 with the projecting bend. The limited freedom of movement within the cavity 6314 allows the wire loop greater deflection than if the end were confined. This deflection reduces the peak forces required (and generated in the socket) when connecting and disconnecting the connector.

[0396] The cavity 6314 comprises a slot opening in the connector body 6308 from the end face of the connector body.

[0397] The other end of the wire loop can be shaped to have a section that wedges into the connector body material. For example, part of the wire can be bent into a curve and encased in the plastic material of the connector body. This section can overlap with the encapsulated end of the 6304 strap inside the connector body.

[0398] To form this connector, the wire loop and the strap can be assembled with a sleeve, and the assembly can be sheathed. For example, the sleeve (which may be made of plastic) can have a blind cavity that receives the end 6340 of the wire loop, and a cavity with an open end that receives the other end of the wire loop (through one end of the cavity) and the end of the strap (through the other end of the cavity). The sleeve can then be sheathed, or at least the cavity with the open end, which holds the strap and the intended fixed end of the loop, can be filled. Alternatively, the sleeve can be formed from two halves that are clamped together over the wire loop. The two halves can, for example, be hinged together. The halves can also be clamped together over the end of the strap 6306, roughly gripping the end of the strap before sheathing.For example, gripping projections 6360 can engage in the end 6362 of the belt.

[0399] According to the embodiment of Fig. In figures 63D to 63J, the soft cover material 6350 is provided by sheathing the connector with a soft material, such as a thermoplastic elastomer, over a length of the highly flexible, loose band 6306 behind the sleeve. This results in the flexible section 6370 transitioning from a rigid section 6372 into the highly flexible band. Preferably, this flexible section becomes increasingly flexible the further it is from the rigid section 6372. For example, the sheathed cover section can taper away from the sleeve, recesses can be provided in the cover (for example, the recesses 6352), or both.

[0400] On masks where the strap of the head fastening part is rigidly connected in a protruding manner (as in some embodiments of the masks described herein), the soft section of the connector provides a soft buffer to protect against impacts from the protruding hard section or prong.

[0401] Preferably, the soft section extends 5 mm to 60 mm across the belt or strap, particularly preferably 10 mm to 20 mm. The soft material can be selected from a wide variety of soft plastics, taking into account the bond with the belt material and the sleeve material.

[0402] In this connector, one of the end faces of the socket 1062 can have a first section 6332 corresponding to the end section 6318 of the loop, a depression or notch 6334 corresponding to the protruding bend 6322, a ridge 6336 fixing the bend 6322 in the notch, and a recessed channel in region 6338 through which the loop can easily enter the slot before the greatest connecting force is required to push the bend 6322 over the ridge 6336.

[0403] The described connector is compact, acts as an extension of the interface frame, and features a simple and intuitive connection and disconnection method.

[0404] Fig. Figures 58 to 61 show a different patient interface with a seal essentially as previously described, and as in Fig. Figures 10 to 12 have features that can eliminate or reduce the need for additional support for the conduit. According to this embodiment, the mask body has hanging stabilizers 6102. One hanging stabilizer is provided on each side of the mask body. Each hanging stabilizer extends over the perimeter of the mask seal and has a foot 6104 for engaging the upper lip of the wearer. Preferably, the stabilizer does not extend beyond the inside of the seal but is spaced forward from the inside of the seal, with the feet 6104 positioned such that they do not come into contact with the wearer when the mask is donned and sits symmetrically on the patient during use. Each foot 6104 may have a pad 6106 made of a soft material, such as soft polymer or elastomer foam or a piece of a hollow silicone extrusion.Instead of being integrated into the frame, the stabilizers can be incorporated into the seal; for example, they can be molded as a single piece of silicone, extending from a point next to the central opening and projecting beyond the lower edge of the seal. In this case, features on the mask body could fix the position of the inner ends of the stabilizers.

[0405] Each stabilizer extends downwards to a region below the seal and is designed to engage the area of ​​the patient's upper lip in the region bounded by the mouth, nose, and nasolabial folds, and preferably not resting against the patient's cheeks. Accordingly, the feet are profiled and positioned to fit within this area. Each stabilizer 6102 and arm 6108 extends from the lateral central section 6110 of the mask body. The shape and material of this arm can be such that the arm is rigid or that it exhibits a desired degree of flexibility. Generally, this arm should be rigid.

[0406] The purpose of the stabilizers is to remain close to the user's upper lip area when the interface is correctly positioned, and to touch the user's upper lip region if the interface is pushed to one side or the other relative to the user's nose, for example, under the influence of the supply line. Gentle pressure on the base 6104 of the stabilizer, which is spaced laterally from the center line of the mask, preferably towards the outermost ends of the mask, supports the mask against the lateral forces of the line and thus prevents the mask from being pushed too far over the face and breaking the seal.

[0407] Furthermore, the stabilizers hang below the mask and support it when it is rotated forward by the weight of the line. In this case, the feet of both stabilizers (6104) touch the user's upper lip and support the position of the mask.

[0408] In the preferred embodiment, the stabilizers are shown with a substantially rigid construction but with flexible or soft pads 6106. To accommodate variations in the patient's geometry, these stabilizers could also be an optional attachment with a connection to the mask, allowing them to be exchanged for stabilizers of a different shape. Alternatively, the stabilizers could be adjustable, for example, by providing hinged sections along the length of the stabilizer, or at the connection point of the arms or feet, or both, which can assume several fixed positions. Alternatively, the arms could be made of a malleable material that can yield considerably. Accordingly, the arms could be bent into a desired position by the material yielding and remain in that position.

[0409] In the embodiment with hinged arms or feet, a connecting arrangement could be provided to link the movement of each stabilizer, or the stabilizers could be supported in their position individually or collectively by a spring or by springs or another compliant element.

[0410] With additional stabilizers, the mask can be placed securely on the patient without requiring additional support for the tubing. This, in turn, allows for a shorter length of the flexible connecting tube 6120. Accordingly, the length of the flexible connecting tube 6210 (which would typically be more flexible than the main supply line) can be reduced to 5 cm to 15 cm, and preferably to approximately 10 cm. In systems with a humidified gas supply and a heated main supply line, this short flexible connecting tube is usually not heated. If the connecting tube needs to be supported with a band or collar, it has a minimum length that generally exceeds 15 cm.If the collar band isn't needed, the shorter connecting tube is only for flexibility, to detach the relatively rigid supply line from the mask and allow the wearer's head more freedom of movement. Since the connecting tube is typically not heated, moisture from the gases inside can condense on the cooler wall surface, creating water droplets that can eventually be blown into the user's nostrils, causing discomfort. Providing a shorter tube, as made possible by lip stabilizers, reduces the likelihood of condensation forming inside the line.

[0411] The interface configuration, consisting of a single flexible head strap, a nose seal, and a low-profile frame that stabilizes on the upper lip, all in one package for all sizes (preferably head strap and seal), can be improved if the short connecting tube is particularly flexible. By flexible tube, we mean that the tube bends easily under applied forces. For example, suitable tubes can be used, as shown below with reference to... Fig. Meet the 65 described test criteria.

[0412] After the test Fig.In diagram 65, a 150 mm long hose is clamped at each end to a cylindrical support that extends into the bore of the hose at each end. This leaves approximately 130 mm of the hose hanging freely between or bridging the supported ends. This bridging section should be in a relaxed state, neither contracted nor stretched. A lateral force of 5 N applied to the middle of the hose should cause a deflection of more than 13 mm.

Claims

[1] Patient interface, which includes the following: a frame (303) and a seal (301), wherein the seal (301) has a patient-facing side with at least one patient opening and a frame-facing side with at least one frame-facing opening, wherein the seal engages in the frame (303) at a lip defined by the circumference of the opening pointing to the frame (303), wherein the frame (303) has a first component (1070) and a second component, wherein the first component (1070) has a first section of a channel (1096) for engaging in the lip of the seal (301), wherein the second component has a second section of the channel (1096) for engaging in the lip of the seal (301), wherein the seal (301) can be brought into and out of engagement with the channel, while the first and second components are connected to form the channel, wherein the frame is formed using rigid materials. [2] Patient interface according to claim 1, wherein the frame is formed using polycarbonate, polyester, polystyrene or nylon. [3] Patient interface according to one of the preceding claims, wherein the frame (303) has a feed opening through a front wall of the frame (303), wherein an annular section (1080) extends from the front wall to define a passage from the inside of the front wall of the frame (303), and wherein a projecting wall extends around the inwardly open end of the annular section and engages in the lip of the seal (301), wherein the front wall of the frame and the ring section together with the other frame parts define an air chamber with a bias flow vent (1018) through a wall of the air chamber and an open area between the ring section and the construction of the channel provides a flow path between the interior of the seal and the air chamber. [4] Patient interface according to claim 3, wherein the bias flow holes are arranged through the wall of the frame in a region of the upper section of the air chamber. [5] Patient interface according to claim 3 or claim 4, wherein the ring section is formed as part of a first component of the frame and the front wall of the frame is formed as part of a second component, wherein the two components are attached to each other to define the air chamber. [6] Patient interface according to claim 5, wherein the projecting wall comprises a channel, the channel receiving the lip of the seal. [7] Patient interface according to claim 5 or 6, wherein the channel follows a closed arc path with a total width greater than the height, such that the air chamber is formed predominantly on both sides of the ring section. [8] Patient interface according to one of claims 5 to 7, wherein the ring section connects to the upper and lower middle sections of the projecting wall and the flow path from the seal to the air chamber passes through both sides of the ring section. [9] Patient interface according to claim 5, wherein the projecting wall is formed as part of the same component as the ring section. [10] Patient interface according to claim 5 or claim 9, wherein the bias flow vent is formed by the front wall of the second component. [11] Patient interface according to one of the preceding claims, wherein the first component has laterally projecting shield sections, wherein the inner sides of the shield sections fit against the outer sides of an outer wall of the seal to limit the deflection of the seal outwards. [12] Patient interface according to one of the preceding claims, wherein the second component has downward and sideways hanging stabilizers for stabilization on the upper lip region of a carrier. [13] Patient interface according to claim 12, wherein the first frame component comprises a skeletal frame, wherein at least part of the stabilizer parts of the component comprises a sheathed soft material.

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