Patient interface and aspects thereof

Abstract

To provide a patient interface which will at least provide the public with a useful choice.SOLUTION: A patient interface includes a seal including a pair of nasal locators extending from a supple background. Each nasal locator includes a tip. The nasal locator becomes narrower moving from the background to the tip. An opening is in the tip of the nasal locator. The nasal locator includes a dome portion adjacent the background and a tubular portion extending from an apex of the dome portion.SELECTED DRAWING: Figure 11A

Description

[Technical Field]

[0001] The present invention relates to a patient interface and aspects of the patient interface for delivering respiratory gas to a patient. [Background technology]

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

[0003] Desirable characteristics for a patient interface used in PAP therapy include being lightweight, comfortable, intuitive to use, providing a good seal, and being stable and safe during use.

[0004] Where this specification refers to patent specifications, other external documents, or other sources, it is generally for the purpose of providing a background for discussing features of the present invention. Unless specifically stated otherwise, the reference to such external documents shall not be construed as an admission in any jurisdiction that such documents or such sources are prior art or form part of the common general knowledge in the art. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present invention to provide a patient interface, or aspects of a patient interface, that provides useful choices to at least the public. [Means for solving the problem]

[0006] In one aspect, the invention can be generally described as a patient interface comprising a nasal seal including a face-contacting side, the nasal seal being formed of a soft, flexible material and including a central portion extending across the base of the nose and side portions extending from each end of the central portion, each side portion extending across a side of the nose; the face-contacting side of the seal being flexible and conforming under internal pressure to the surface of the wearer's nose, including the outer surfaces of the sides of the nose at the side portions of the seal; and an outer side which includes regions that are much stiffer than the flexible inner side and which extend to the side portions of the seal.

[0007] According to another aspect, the side portions of the seal are substantially parallel to one another and substantially perpendicular to the central portion of the seal.

[0008] According to another aspect, the outer walls of the side portions of the seal are aligned to form an angle between 0 and 30 degrees between their orientations.

[0009] According to another aspect, the seal includes a pair of nose locators on the face-contacting side, and on the face-contacting side of the seal, an area of ​​the seal immediately adjacent to and including the nose locators is stiffer than an area surrounding this area.

[0010] According to another aspect, the peripheral portion of the seal that interfaces with the face-contacting side of the exterior side is flexible to allow the interior side of the seal to displace relative to the exterior side.

[0011] According to another aspect, the exterior side of the central portion of the seal includes an aperture that allows gas to pass to the interior of the seal.

[0012] According to another embodiment, the flexible portion of the seal comprises a silicone material having a thickness of 0.05 mm to 0.5 mm.

[0013] According to another embodiment, the flexible portion of the seal comprises an elastomer having a thickness of 0.1 mm to 0.2 mm.

[0014] According to another embodiment, the rigid portion of the seal comprises a silicone material having a thickness of 2 mm to 5 mm.

[0015] According to another embodiment, the rigid portion of the seal comprises an elastomer having a thickness of 2 mm to 3 mm.

[0016] According to another embodiment, the area immediately adjacent to and including the nasal locator comprises a silicone material having a thickness of between 0.5 mm and 2 mm.

[0017] According to another embodiment, the overall width of the seal from the outer surface of one side portion to the outer surface of the other side portion is between 30 mm and 60 mm.

[0018] According to another embodiment, the seal has a total depth from the outer surface of the central portion to the line where it joins the ends of each side portion is between 40 mm and 65 mm.

[0019] According to another aspect, the patient interface includes a body assembled to the nasal seal, the body being formed from a stiffer material than the nasal seal and forming, together with the nasal seal, an enclosure having an inlet opening and a patient outlet opening, the inlet opening to which the swivel elbow is connected.

[0020] According to another aspect, the connection of the swivel elbow to the body provides for rotation of the swivel elbow relative to the body and for pivoting of the swivel elbow relative to the body about at least a transverse axis.

[0021] According to another aspect, the connection includes a ball-and-socket joint.

[0022] According to another aspect, the elbow includes a first end, a second end, and a flow path between the first end and the second end, the flow path being aligned in a first direction at the first end and in a second direction at the second end, the first direction and the second direction forming an angle between 120° and 180°. According to another embodiment, the angle is between 120° and 150°.

[0023] According to another embodiment, the angle is between 130° and 140°.

[0024] According to another aspect, the elbow includes a washout vent.

[0025] According to another aspect, the gas relief vent is aligned with the gas flow path from the nose seal and body assembly to the elbow.

[0026] According to another aspect, the gas relief vent comprises a plurality of holes through the wall of the elbow.

[0027] According to another aspect, the patient interface includes a body assembled to the seal and a looped strap extending from the assembled body and nasal seal, the strap exiting at one end from a first portion of the assembled body and nasal seal and at the other end from a second portion of the assembled body and nasal seal.

[0028] According to another aspect, the strap includes a single, non-dividing band along the length of the strap that engages the wearer's head.

[0029] According to another aspect, the strap engages the body at both ends.

[0030] According to another aspect, the body is formed from a rigid material, the strap is relatively flexible compared to the body and includes a soft portion, the portion of the strap that engages the body is formed from a material that is more flexible than the material of the body and less flexible than the material of the strap, and the soft portion forms a soft extension of the body when engaged with the body.

[0031] According to another embodiment, the flexible portion extends along the strap from 5 mm to 60 mm.

[0032] According to another aspect, the strap engages the body at both ends with detachable connectors.

[0033] According to another aspect, the strap includes a soft cover portion extending from the detachable connector along the strap a distance of 5 mm to 60 mm, the soft cover portion being formed of a softer material than the main body.

[0034] According to another embodiment, the band is thin, preferably less than 10 mm wide.

[0035] According to another embodiment, the width of the band is less than 6 mm.

[0036] According to another embodiment, the stiffness of the band is less than 2 N per 100 mm of extension from the relaxed state.

[0037] According to another aspect, the band is formed of a braided or braided yarn that incorporates filaments of a highly elastic material and filaments of a much stiffer material.

[0038] According to another aspect, the strap includes soft end portions that are stiffer than the strap between the end portions but softer than the body, the soft end portions also serving as soft extensions of the body.

[0039] According to another aspect, the patient interface includes a tube depending from the seal and body, and a tube support connected to the tube and connectable to the patient's neck or clothing.

[0040] According to another aspect, the tube support includes a collar that is fastenable around the neck of the wearer.

[0041] According to another aspect, the collar has a first end portion and a second end portion, the first end portion and the second end portion including fastening configurations that allow the end portions to be fastened with a selectable amount of overlap.

[0042] According to another aspect, the collar includes a third end portion, a fourth end portion, and a connector connecting the third end portion to the fourth end portion.

[0043] According to another aspect, the connector is configured to release the third end portion from the fourth end portion upon application of a tension on the connector that is greater than a release tension, the release tension being less than 10N.

[0044] According to another embodiment, the width of the collar is between 30 mm and 60 mm.

[0045] According to another aspect, the collar includes a core material and a cover material surrounding the core material.

[0046] According to another aspect, the core material is a dimensionally stable, breathable mesh.

[0047] According to another aspect, the cover material is a braided or knitted natural fiber.

[0048] According to another aspect, the tube support includes a tether extending from the collar, with the connector secured or securable to the tube at one end.

[0049] According to another aspect, the tether includes a connector at the outer end, and the collar passes through a second connector.

[0050] According to another aspect, the tether includes a first end, a second end, and a connector connecting the first end and the second end, the connector configured to release upon application of a tension greater than a release tension, the release tension being less than 10 N.

[0051] According to another aspect, the strap connector includes a first portion and a second portion, and in an engaged state, the first portion pivots relative to the second portion.

[0052] According to another aspect, the connector that engages the tube includes a ring.

[0053] According to another aspect, the patient interface includes a body connected to the seal, the body including a nasal seal engagement portion that engages an exterior of the seal, an inlet opening, and at least one strap engagement portion from which extends a loop strap for securing the interface to the patient.

[0054] According to another aspect, the patient interface includes a soft intermediate portion from which the loop strap extends from the strap engaging portion, the soft intermediate portion being formed of a material that is stiffer than the strap but softer than the material of the body.

[0055] According to another aspect, the body includes two strap-engaging portions, each of which extends laterally away from the entrance opening from opposite sides of the entrance opening.

[0056] According to another aspect, each strap-engaging portion extends away from the inlet opening in a region where the strap-engaging portion overlaps the outer wall of the seal.

[0057] According to another aspect, the central portion of the body defines a convex shape that generally matches the convex shape of the outer wall of the body, with the strap-engaging portions extending from lateral ends of the central portion, the strap-engaging portions extending away from the central portion at an angle aligned outwardly relative to the generally convex shape.

[0058] According to another aspect, the strap engaging portion extends away from the outer wall of the seal at a thread angle of greater than 30 degrees.

[0059] According to another embodiment, the length of the strap engaging portion from the point where it branches off from the outer wall of the seal is 50% to 150% of the equivalent length of the outer wall of the seal.

[0060] According to another aspect, the patient interface includes a body engaged with the nasal seal, the body being more rigid than the nasal seal, and a lip support depending from the body, the lip support extending beyond an edge of the seal.

[0061] According to another aspect, the lip support includes one or more pads that engage the upper lip portion of the wearer.

[0062] According to another aspect, the lip support includes two spaced apart depending legs on opposite lateral regions of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

[0063] According to another aspect, each leg carries a pad portion facing the upper lip.

[0064] According to another aspect, the legs are shaped to be less stiff about an axis parallel to the portion of the wearer's lips that they contact than about an axis perpendicular to the plane of the lips.

[0065] In another aspect, the invention may be generally described as headgear for a patient interface, the headgear including an elastic band having a width of 3 mm to 6 mm, a stiffness that provides an extension of 150 mm with a force of less than 2 N, a first end that is connected or connectable to a first lateral portion of a mask, and a second end that is connected or connectable to a second lateral portion of the mask.

[0066] According to another embodiment, the length of the band is between 300 mm and 400 mm at its relaxed length.

[0067] According to another embodiment, the band lengthens by 60 mm to 110 mm when a stretching force of 1 N is applied.

[0068] According to another embodiment, the band is constructed from a braided or braided yarn, the yarn including filaments of a first material and filaments of a second material that is highly elastic but much softer than the first material.

[0069] According to another aspect, the band comprises a braided yarn, the yarn comprising elastane filaments with a spun wrapper.

[0070] According to another embodiment, the band comprises a plurality of braided thread bundles, each thread bundle comprising at least two threads, and each thread comprising an elastane core and a spun wrapper.

[0071] According to another aspect, the first strap end, the second strap end, or both, include a soft cover portion extending between 5 mm and 60 mm along the strap, the soft cover portion being stiffer than the strap.

[0072] According to another aspect, the cover portion is of a softer material than the lateral portions of the mask to which it is connected.

[0073] According to another aspect, the headgear includes a first connector at a first end and a second connector at a second end.

[0074] According to another aspect, the connector includes a resiliently deformable spring clip engaged with the clip body.

[0075] According to another aspect, the connector includes a cover that surrounds and at least substantially encloses the clip body and a portion of the band, the cover being formed of a material that is stiffer than the band and softer than the material of the clip body.

[0076] According to another aspect, the invention may consist in a patient interface including a strap according to any one or more of the preceding paragraphs.

[0077] In another aspect, the invention can be generally described as a patient interface including a nasal seal including a face-contacting side, the nasal seal being formed of a soft, flexible material; a body assembled to the nasal seal, the body being formed of a stiffer material than the nasal seal and forming, together with the nasal seal, an enclosure having an inlet opening and a patient outlet opening; and a lip support depending from the body and extending beyond an edge of the seal.

[0078] According to another aspect, the lip support includes one or more pads for engaging an upper lip portion of the wearer.

[0079] According to another aspect, the lip support includes two spaced apart depending legs on opposite lateral regions of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

[0080] According to another aspect, each leg carries a pad portion facing the upper lip.

[0081] According to another aspect, the legs are shaped to be less stiff about an axis parallel to the portion of the wearer's lips that they contact than about an axis perpendicular to the plane of the lips.

[0082] According to another aspect, the patient interface includes a gas delivery tube depending from the body and a looped strap extending from the assembled frame and nose seal, the strap exiting at one end from a first portion of the assembled body and nose seal and at the other end from a second portion of the assembled body and nose seal.

[0083] In another aspect, the invention may be generally described as a patient interface including a mask, a tube depending from the mask, and a tube support connected to the tube and including a collar fastenable around the neck of a wearer.

[0084] According to another aspect, the collar has a first end portion and a second end portion, the first end portion and the second end portion including fastening configurations that allow the end portions to be fastened with a selectable amount of overlap.

[0085] According to another aspect, the collar includes a third end portion, a fourth end portion, and a connector connecting the third end portion to the fourth end portion.

[0086] According to another aspect, the connector is configured to release the third end portion from the fourth end portion upon application of a tension on the connector that is greater than a release tension, the release tension being less than 10N.

[0087] According to another embodiment, the width of the collar is between 30 mm and 60 mm.

[0088] According to another aspect, the collar includes a core material and a cover material surrounding the core material.

[0089] According to another embodiment, the core material is a dimensionally stable, breathable mesh.

[0090] According to another embodiment, the cover material is a braided or knitted natural fiber.

[0091] According to another aspect, the tube support includes a tether extending from the collar, with the connector secured or securable to the tube at one end.

[0092] According to another aspect, the tether includes a connector at the outer end, and the collar passes through a second connector.

[0093] According to another aspect, the tether includes a first end, a second end, and a connector connecting the first end and the second end, the connector configured to release upon application of a tension greater than a release tension, the release tension being less than 10 N.

[0094] According to another aspect, the tether connector includes a first portion and a second portion, and in an engaged state, the first portion can pivot relative to the second portion.

[0095] In another aspect, the invention can be generally described as a patient interface comprising: a nasal seal including a face-contacting side, the nasal seal formed from a soft, flexible material and including a central portion extending across the base of the nose and side portions extending from each end of the central portion, each side portion extending across a side of the nose; a body connected to the seal, the body including a nasal seal engaging portion that engages an outward-facing side of the seal; an entrance opening, at least two strap engaging portions, each strap engaging portion extending laterally away from the entrance opening from opposite sides of the entrance opening; and a strap extending between the strap engaging portions, the central portion of the body generally defining a convex shape that matches the convex shape of an outer wall of the body, the strap engaging portions extending from lateral ends of the central portion, the strap engaging portions extending away from the central portion at an angle aligned outwardly relative to the generally convex shape.

[0096] According to another aspect, the strap engaging portion extends away from the outer wall of the seal at a thread angle of greater than 30 degrees.

[0097] According to another embodiment, the length of the strap engaging portion from the point where it branches off from the outer wall of the seal is 50% to 150% of the equivalent length of the outer wall of the seal.

[0098] According to another aspect, the patient interface includes a soft intermediate portion from which the loop strap extends from the strap engaging portion, the soft intermediate portion being formed of a material that is stiffer than the strap but softer than the material of the body.

[0099] In another aspect, the invention can be generally described as a patient interface including a mask that covers at least the nostrils of a user, the mask having a single looped head strap extending from both sides of the mask, and a supply conduit less than 200 mm in length coupled to the mask for free swivel movement, including substantial rotation about multiple orthogonal axes.

[0100] According to another embodiment, the feeding tube is flexible to the extent that the tube passes the test described herein with reference to FIG.

[0101] In another aspect, the invention can be said to reside in a patient interface that generally includes a mask that covers at least the nostrils of a user, a supply port on the mask that receives a supply of gas, and a bias flow vent on the mask that extends from the inside of the mask to the outside of the mask, the bias flow vent directing flow in a direction less than 45° relative to the frontal plane of an imaginary wearer's head and generally toward the forehead.

[0102] According to another aspect, the bias flow vent includes at least one bias flow aperture in a wall of the mask, the portion of the wall having the bias flow aperture aligned at greater than 45° relative to the wearer's frontal plane.

[0103] According to another aspect, the wall portion having the bias diversion holes is disposed within the front wall of the mask, and forms a shelf relative to the surrounding portion of the front wall.

[0104] According to another aspect, a plurality of bias diverter holes are distributed in a curve around the upper front surface of the interface.

[0105] According to another embodiment, the mask has a general U-shape or V-shape that encases the user's nose, and the bias flow vent is located at the base of the U or V.

[0106] According to another aspect, the seal does not cover the bridge of the wearer's nose.

[0107] In another aspect, the invention can be generally said to reside in a patient interface including a frame and a seal, wherein the seal includes a patient-facing side having at least one patient-side opening and a frame-facing side having at least one frame-side opening, the seal engages with the frame at a lip defined around the frame-side opening, the frame including a first component and a second component, the first component including a first portion of a channel for engaging the lip of the seal, the second component including a second portion of the channel for engaging the lip of the seal, and the seal is engageable and disengageable from the channel by the first and second components connected to form the channel.

[0108] In another aspect, the invention may be generally described as a patient interface including a frame and a seal, wherein the frame includes a first component and a second component engaged to one another, the first component including a portion forming a receptacle with a surface that contacts a movable portion of a freely swivel connector, the second component including an outer cover with an opening at the receptacle in the first component, and the patient interface further including a connector including an interface portion that protrudes beyond the cover to the receptacle in the first component to engage with the receptacle in the first component for free swivel movement.

[0109] According to another aspect, the first component is formed of a different material than the cover, and the cover and connector are formed of the same material.

[0110] According to another aspect, the patient interface is a seal including a pair of nasal locators extending from a flexible back portion, each nasal locator including a tip, the nasal locators tapering from the back portion to the tip, the seal and an opening at the tip of the nasal locator, the opening and the tip portion of the nasal locator having an oval or elliptical cross-sectional shape with a ratio of the length of the major axis to the length of the minor axis greater than 1.5.

[0111] According to another embodiment, the ratio of the length of the major axis to the length of the minor axis is 1.5-3.

[0112] According to another aspect, the distal portion of the nasal locator includes a lip adjacent the distal opening, the lip being thickened relative to an adjacent portion of the tubular portion.

[0113] According to another aspect, the nose locator includes a dome-shaped portion adjacent the dorsal portion and a tubular portion extending from an apex of the dome-shaped portion.

[0114] According to another aspect, the dome-shaped portion extends around at least 60% of the circumference of the nasal locator.

[0115] According to another aspect, the dome-shaped portion extends completely around the periphery of the nasal locator.

[0116] According to another aspect, the tubular portion tapers from the domed portion to the tip portion.

[0117] According to another aspect, the cross section of the nasal locator in a plane parallel to the plane of the tip opening is oval or elliptical across the tubular portion and the top of the dome-shaped portion.

[0118] According to another aspect, the ratio of the length of the major axis of the oval cross section to the length of the minor axis of the oval cross section gradually decreases from the tip of the tubular portion to the base of the dome-shaped portion.

[0119] According to another embodiment, the flow projecting axes of the two nasal locators meet at a point 10 mm to 40 mm from the tip of the nasal locators.

[0120] According to another embodiment, the central axes of the nose locators that protrude beyond the tips of the locators meet closest at a point 10 mm to 20 mm beyond the tips of the nose locators.

[0121] According to another aspect, when the tip opening of the nose locator projects into the frontal plane of an imaginary wearer, the oval shape of the tip opening is aligned so that its major axes meet at an angle between 60 degrees and 120 degrees.

[0122] In another aspect, the invention can be generally described as a patient interface including a frame and a seal, the seal including a patient side with at least one patient opening and a frame side with at least one frame opening, the seal engaging the frame at a lip defined by the periphery of the frame opening, the frame including a front portion in the area of ​​a swivel connection to a supply conduit, the front portion being inclined with respect to the frontal plane of an imaginary wearer of the interface so that a lower edge of the portion is closer to the frontal plane than an upper edge of the portion, and the connector redirects flow from the connector inlet to the connector outlet at an angle of between 30 and 70 degrees, the connector and the inclined outer surface portion of the mask frame together allowing free swivel movement of the conduit so that the conduit assumes a position approximately parallel to the imaginary wearer's frontal plane and the connector remains close to the wearer's face.

[0123] According to another aspect, the connector does not include a bias flow vent.

[0124] In another aspect, the invention can be generally described as a patient interface including a frame and a seal, the seal including a patient-facing side with at least one patient-side opening and a frame-facing side with at least one frame-side opening, the seal engaging the frame at a lip defined by the periphery of the frame-side opening, the frame including a supply opening through a front wall of the frame, a ring portion extending from the front wall and defining a passageway protruding from an inner surface of the front wall of the frame, and a protruding wall passing around an interior open end of the ring portion and engaging the lip of the seal, the front wall of the frame and the ring portion together with other portions of the frame defining a plenum chamber, and a bias flow vent through the wall of the plenum chamber and an open area between the ring portion and the channel structure providing a flow path between the interior of the seal and the plenum chamber.

[0125] According to another aspect, bias diversion holes are disposed through the wall of the frame in an upper portion of the plenum chamber.

[0126] According to another aspect, the ring portion 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, the two components being secured together to define the plenum chamber.

[0127] According to another aspect, the protruding wall includes a channel, the channel receiving the lip of the seal.

[0128] According to another aspect, the channel follows a closed curved path whose overall width is greater than its height, such that the plenum chamber is formed primarily on either side of the ring portion.

[0129] According to another aspect, the ring portion connects to the upper and lower central portions of the protruding wall, and the flow path from the seal to the plenum chamber passes through both sides of the ring portion.

[0130] According to another aspect, the protruding wall is formed as part of the same component as the ring portion.

[0131] According to another aspect, a bias flow vent is formed through the front wall of the second component.

[0132] According to another aspect, the first component includes a laterally projecting shielding portion, an inner surface of the shielding portion attached to an outer surface of the outer wall of the seal to inhibit outward deflection of the seal.

[0133] According to another aspect, the second component includes downwardly and laterally depending stabilizers for stabilization in the upper lip area of ​​the wearer.

[0134] According to another aspect, the first frame component comprises a skeletal frame, and a minimum portion of the stabilizer portion of the component comprises an overmolded soft material.

[0135] In another aspect, the invention can be said to reside in a patient interface that generally includes a soft, resilient seal, a rigid frame, headgear connected to the frame, a rigid protrusion at the connection of the headgear to the frame, the headgear being very flexible within 60 mm of the frame, and a soft portion between this point and the protrusion that is stiffer than the flexible portion of the headgear but made of a material softer than the rigid frame.

[0136] According to another aspect, the protrusions resemble pins and are long and thin.

[0137] According to another aspect, the soft portion extends from the general path of the pin.

[0138] According to another aspect, the projection comprises a combination of a portion of the mask frame and a clip portion of the headgear.

[0139] According to another embodiment, the flexible portion is part of the headgear.

[0140] According to another aspect, the headgear is a simple single loop strap.

[0141] According to another aspect, the projection projects laterally beyond the width of the seal.

[0142] In another aspect, the invention can be generally described as a patient interface comprising: a seal including a pair of nasal locators extending from a flexible back portion, each nasal locator including a tip, the nasal locators tapering from the back portion to the tip; and an opening at the tip of the nasal locator, the nasal locator further including a dome-shaped portion adjacent the back portion and a tubular portion extending from the apex of the dome-shaped portion.

[0143] According to another embodiment, the dome-shaped portion extends around at least 60% of the circumference of the nasal locator.

[0144] According to another aspect, the dome-shaped portion extends completely around the periphery of the nasal locator.

[0145] According to another aspect, the tubular portion tapers from the domed portion to the tip portion.

[0146] According to another aspect, the cross section of the nasal locator in a plane parallel to the plane of the tip opening is oval or elliptical across the tubular portion and the top of the dome-shaped portion.

[0147] According to another aspect, the ratio of the length of the major axis of the oval cross section to the length of the minor axis of the oval cross section gradually decreases from the tip of the tubular portion to the base of the dome-shaped portion.

[0148] According to another embodiment, the flow projection axes of the two nasal locators meet at a point 10 mm to 40 mm from the tip of the nasal locators.

[0149] According to another embodiment, the central axes of the nose locators that protrude beyond the tips of the locators meet closest at a point 10 mm to 20 mm beyond the tips of the nose locators.

[0150] According to another embodiment, the cross-sectional shape of the distal opening and distal portion of the nasal locator is an oval or ellipse having a ratio of the length of the major axis to the length of the minor axis greater than 1.5.

[0151] According to another embodiment, the ratio of the length of the major axis to the length of the minor axis is 1.5-3.

[0152] According to another aspect, the distal portion of the nasal locator includes a lip adjacent the distal opening, the lip being thickened relative to an adjacent portion of the tubular portion.

[0153] According to another aspect, when the tip opening of the nose locator projects into the frontal plane of an imaginary wearer, the oval shape of the tip opening is aligned so that its major axes meet at an angle between 60 degrees and 120 degrees.

[0154] According to another aspect, the invention may consist in an interface according to any of the preceding paragraphs.

[0155] The term "comprising" is used herein and in the claims to mean "consisting at least in part of." When interpreting language in the present specification and claims that includes "comprising," other features or features described by other terms may also be present. Related words such as "comprise" and "comprises" are to be interpreted in the same manner.

[0156] Where reference is made herein to patents, other external documents, or other sources, this is generally to provide a background for discussing features of the present invention. Unless specifically stated otherwise, the reference to such external documents should not be construed as an admission in any authority that such documents or such sources are prior art or form part of the common general knowledge in the art.

[0157] A preferred embodiment of the present invention will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0158] [Figure 1] FIG. 1 is a perspective view of a person wearing a patient interface. [Figure 2] FIG. 2 is a perspective view of the patient interface of FIG. 1 without the patient shown. [Figure 3] FIG. 3 is an exploded view showing the components that make up the interface of FIG. 2. [Figure 4A] 3A-3C show the sealing component of the patient interface of FIG. 2 from different angles; [Figure 4B] 3A-3C show the seal component of the patient interface of FIG. 2 from different angles, showing the seal from the patient-facing side. [Figure 4C] 3A-3C show the seal component of the patient interface of FIG. 2 from different angles; [Figure 5A] FIG. 10 is an exploded view of the seal and mask frame showing how the seal and mask frame are assembled together. [Figure 5B] FIG. 3 is a side view of the interface of FIG. 2, partially disassembled, showing the connection between the elbow and the mask frame. [Figure 5C] FIG. 3 is a perspective front view of the interface of FIG. 2 showing the assembly of the elbow and mask frame with a gas relief vent in the elbow. [Figure 6] FIG. 10 is a front view of the assembled seal and mask frame. [Figure 7A] FIG. 1 is a top view of the assembled seal and mask frame. [Figure 7B] FIG. 7B is a side view of the seal and frame of FIG. 7A, not in cross section. [Figure 7C] FIG. 4D is a patient-side view of the seal of FIGS. 4A and 4C. [Figure 7D] 7D is a side elevational view of the seal of FIG. 7C, with the cross section taken along line EE. [Figure 8] FIG. 7B is a side view of the seal and mask frame of FIG. 7A taken along line DD. [Figure 9A] 7D is a top view of the seal of FIG. 7C, with the cross section taken along line FF of FIG. 7D. [Figure 9B] 7D is a top view of the seal of FIG. 7C, with the cross section taken along line GG of FIG. 7D. [Figure 10A] 10A and 10B are perspective and front views, respectively, of a patient interface incorporating several of the inventions described herein. [Figure 10B] FIG. 10B is a perspective view and FIG. 10B is a side view of a patient interface incorporating several of the inventions described herein. [Figure 10C] FIG. 10C is a perspective view and FIG. 10C is a rear view of a patient interface incorporating several inventions described herein. [Figure 11A] FIG. 10B is a top view of the soft seal component of the interface of FIGS. 10A-10C. [Figure 11B] FIG. 10B is a front view of the soft seal component of the interface of FIGS. 10A-10C. [Figure 11C] FIG. 10C is a rear view of the soft seal component of the interface of FIGS. 10A-10C taken from a position directly facing the open end of the nasal locator. [Figure 11D] 11C is a cross section through section CC. [Figure 11E] 11C through line DD. [Figure 11F] 11B is a cross section taken along line EE in FIG. 11E. [Figure 11G] 11B is a cross section taken along line GG in FIG. 11E. [Figure 11H] This is a cross section taken through line HH in FIG. 11E. [Figure 12A] FIG. 16 is a front perspective view of a frame assembly of the interface of FIGS. 10A-10C. [Figure 12B] FIG. 10C is a perspective view of the rear of the frame assembly of the interface of FIGS. 10A-10C. [Figure 12C] FIG. 1D is a side view of a frame assembly of the interface of FIGS. 10A-10C. [Figure 12D]FIG. 1C is an assembly drawing of two components of the frame assembly of the interface of FIGS. 10A-10C. [Figure 12E] FIG. 10B is a rear view of the frame assembly of the interface of FIGS. 10A-10C. [Figure 12F] FIG. 10B is a front view of the frame assembly of the interface of FIGS. 10A-10C. [Figure 12G] FIG. 12C is a side cross-sectional view through line AA of FIG. 12F. [Figure 12H] FIG. 12C is a top cross-sectional view taken along line BB of FIG. 12F. [Figure 12I] FIG. 10 is a rear view of an alternative frame assembly having a different channel path for securing the lip of the seal. [Figure 13] 10 illustrates another embodiment of an interface with an inflatable seal, the interface including a seal body, a frame, a tube, and a head strap. [Figure 14] 14 shows the seal body of the interface of FIG. 13. [Figure 15] FIG. 14 is a perspective view of the frame and seal body of the interface of FIG. 13. [Figure 16] FIG. 14 is a front view of the frame and seal body of the interface of FIG. 13. [Figure 17] FIG. 14 is a side view of the frame and seal body of the interface of FIG. 13. [Figure 18] 18 is a cross-sectional view of the frame and seal body taken along line BB of FIG. 17. [Figure 19] FIG. 10 is an alternative cross-sectional view of the seal body. [Figure 20] FIG. 17 is a cross-sectional view of the seal body taken along line AA in FIG. 16. [Figure 21] 10 is an alternative embodiment of the seal body of the interface of the present invention. [Figure 22] 10 is yet another embodiment of the seal body of the interface of the present invention. [Figure 23] 10 is another embodiment of the seal body of the interface of the present invention. [Figure 24] 1 illustrates a first embodiment of a head strap that may be used with the interface of the present invention. [Figure 24a] 25 is an alternative cross-sectional view of the head strap of FIG. 24. [Figure 24b] 25 is an alternative cross-sectional view of the head strap of FIG. 24. [Figure 25] 10 illustrates a second embodiment of a head strap that may be used with the interface of the present invention. [Figure 25a] 26 shows an alternative cross-sectional view of the head strap of FIG. 25. [Figure 25b] 26 shows an alternative cross-sectional view of the head strap of FIG. 25. [Figure 26] 10 illustrates a third embodiment of a head strap that may be used with the interface of the present invention. [Figure 27] 10 illustrates a fourth embodiment of a head strap that may be used with the interface of the present invention. [Figure 27a] 28 shows the extensible portion of the head strap of FIG. 27 in an extended state. [Figure 28] 10 illustrates a fifth embodiment of a head strap that may be used with the interface of the present invention. [Figure 29] 10 illustrates a sixth embodiment of a head strap that may be used with the interface of the present invention. [Figure 29a] 10 illustrates a sixth embodiment of a head strap that may be used with the interface of the present invention. [Figure 30] 1 shows a first embodiment of the connection between the seal body and the frame of the interface of the present invention. [Figure 31] 10 shows a second embodiment of the connection between the seal body and the frame of the interface of the present invention. [Figure 32] 10 shows a third embodiment of the connection between the seal body and the frame of the interface of the present invention. [Figure 33] 10 shows a fourth embodiment of the connection between the seal body and the frame of the interface of the present invention. [Figure 34]1 illustrates a first embodiment of a prosthesis that may be used with an interface of the present invention to attach a tube connected to the interface to a user. [Figure 35] 10 illustrates a second embodiment of a prosthesis that may be used with the interface of the present invention to attach a tube connected to the interface to a user. [Figure 36] 10 illustrates a third embodiment of a prosthesis that may be used with the interface of the present invention to attach a tube connected to the interface to a user. [Figure 37] 10 illustrates a fourth embodiment of a prosthesis that may be used with an interface of the present invention to attach a tube connected to the interface to a user. [Figure 38] 10 illustrates a fifth embodiment of a prosthesis that may be used with an interface of the present invention to attach a tube connected to the interface to a user. [Figure 39] 10 illustrates a sixth embodiment of a prosthesis that may be used with an interface of the present invention to attach a tube connected to the interface to a user. [Figure 40] 10 illustrates a seventh embodiment of a prosthesis that may be used with an interface of the present invention to attach a tube connected to the interface to a user. [Figure 41] FIG. [Figure 42] FIG. 42 is a perspective view of a patient wearing the support collar of FIG. 41. [Figure 43] 42 is a perspective view of the collar of FIG. 41 from a different angle. [Figure 44] FIG. 42 is a front view of a patient wearing the collar of FIG. 41. [Figure 45] FIG. 42 is a top view of the collar of FIG. 41. [Figure 46] FIG. 42 is a top view of a portion of the collar of FIG. 41 showing the dome fastening connector. [Figure 47] FIG. 10 is a top view of a portion of a collar including an alternative fastener. [Figure 48] FIG. 10 is a top view of a portion of a collar including an alternative fastener. [Figure 49] FIG. 10 is a top view of a portion of a collar including another alternative fastener. [Figure 50A] FIG. 10 is a side view of a portion of a collar including a locking clip in an engaged configuration. [Figure 50B] FIG. 50B is a side view of the portion of the collar from FIG. 50A in a disengaged state. [Figure 51A] FIG. 10 is a side view of a portion of a collar including a locking clip according to an alternative embodiment in a disengaged state. [Figure 51B] FIG. 51B is a side view of the portion of the collar of FIG. 51A in an engaged state. [Figure 52] FIG. 10 is a perspective view of a tether including a quick disconnect connector and depending from a portion of a collar. [Figure 53] FIG. 10 is a perspective view showing a tether depending from a collar, the tether including a quick disconnect connector that can also swivel. [Figure 54A] FIG. 51C is a top view of a tether similar to that of FIG. 51B, but at its shortest length. [Figure 54B] FIG. 54B is a top view of the tether of FIG. 54A with the quick release connector disengaged. [Figure 54C] FIG. 54B is a side view of the tether of FIG. 54A. [Figure 55] FIG. 10 is an exploded view showing the connection of the tether ring from the support collar to the conduit. [Figure 56] FIG. 10 is a perspective view of an interface including an alternative configuration for supporting a conduit from a patient. [Figure 57] FIG. 10 is a perspective view of a patient wearing an interface including another alternative configuration for supporting a conduit on the patient. [Figure 58] FIG. 1 is a side elevational view of a frame and seal, the frame incorporating a depending lip stabilizer in accordance with another invention herein. [Figure 59] FIG. 59 is a top view of the frame and seal of FIG. 58. [Figure 60] FIG. 59 is a front view of the frame and seal of FIG. 58. [Figure 61] FIG. 59 is a perspective view of an interface incorporating the frame and seal of FIG. 58. [Figure 62] 10 is a graph of extension force tested against extension of sample strap material. [Figure 63A] 10A-10C depict a preferred headgear embodiment of the interface, and is a perspective view of a portion of the headgear including the ends of the head straps and the connector. FIG. [Figure 63B] 10A-10C depict a preferred headgear embodiment of the interface, including a top view of the straps and connectors. [Figure 63C] 10A-10C depict a preferred headgear embodiment of the interface of FIGS. 10A-10C, showing (in cross section) both the connector and the receptacle in the frame assembly that receives the connector in use. [Figure 63D] 1 illustrates another preferred headgear, showing a portion of the headgear, a connector, and a portion of the frame assembly connecting thereto. [Figure 63E] FIG. 63E is a top view of the assembly of FIG. 63D. [Figure 63F] FIG. 63B is a cross-sectional view taken along line AA of FIG. 63E. [Figure 63G] FIG. 63H is a side view of the strap portion and connector of FIG. 63G. [Figure 63H] 63H is a cross section through line BB of the connector and strap of FIG. 63G. [Figure 63I] FIG. 63H is an assembly view of an exploded view of the strap portion and connector of FIG. 63G. [Figure 63J] FIG. 63C is a perspective view of the strap portion and connector of FIG. 63B. [Figure 64] 10 is a graph of extension force tested against extension of different sample strapping materials. [Figure 65] FIG. 1 shows a test apparatus for measuring flexibility of breathing tubes. DETAILED DESCRIPTION OF THE INVENTION

[0159] The present invention relates particularly, but not exclusively, to an interface including an inflatable nasal seal having a flexible wall structure. The inflatable seal has a pair of positioning protrusions that engage the user's nares. The positioning protrusions provide a flow of gas to the user from within the seal. The patient side of the seal is flexible and of sufficient size and shape that when the inflatable seal is pressed against the user's face with the positioning protrusions engaged by the user's nares, the seal conforms to the surface of the user's face (particularly the sides of the nose and upper lip) and provides a seal. The outwardly facing wall of the seal is more rigid, supporting the inner wall of the seal in a position that wraps around the wearer's nose.

[0160] The seal is formed from a material with sufficient elasticity and yield strength that the combination of elasticity and yield strength allows the cover to be flexible. The flexible portion can undergo repeated rapid deformation without failure. Possible materials include latex, vinyl, silicone, and polyurethane. Typically, the flexible portion of the seal has a wall thickness of less than 0.5 mm, and can be less than 0.2 mm.

[0161] The seal body includes a pair of nasal locators projecting from the patient-facing wall, preferably integrally formed with the seal, each nasal locator including an outlet opening for supplying gas from inside the cover to a user wearing the interface.

[0162] The seal body includes an inlet opening generally opposite the nasal locator.

[0163] A significant portion of the seal body or cover is flexible. The areas adjacent to and including the nasal locators and the areas adjacent to and including the inlet opening are much stiffer. These areas retain the overall shape of the seal and can be of any suitable stiffness. These areas can be made of a stiffer material or can be made of the same thickened material as the rest of the cover.

[0164] The seal is supported by the mask body or frame, and the inlet opening of the seal is attached to the frame or directly to a conduit extending through the frame.

[0165] The frame is preferably of minimalist design, providing minimal visual obstruction, allowing for clear vision and allowing the user to wear eyeglasses while wearing the interface.

[0166] The frame may be formed by injection molding from an elastomeric material such as silicone or polyurethane, or a more rigid material such as polycarbonate, or polyester, polystyrene or nylon may be used.

[0167] The preferred frame includes attachment points for connecting straps to the frame, where the straps are secured at the strap attachment points.

[0168] In other forms, the nose seal body may include integral strap attachment points. These attachments may be connecting elements on the surface of the cover, but they may also be integral straps or wings formed in the cover that extend from either side of the cover.

[0169] The interface is intended to be supported by a single strap that passes over the back of the head. The strap may be made of a resilient or elastomeric material. For example, suitable strap materials include woven elastic strips or narrow strips of foam and fabric, such as Breathoprene™. The strap that extends around the back of the head applies pressure to the mask and helps maintain a seal on the user's face.

[0170] Preferred straps according to one or more of the inventions are now described later in this specification.

[0171] A flexible tube extends from the frame, carries breathable gas, and has a distal end that connects to the CPAP main delivery tube.

[0172] A connector may connect the tube to the frame. The connection mechanism may be any suitable connection, including a snap fit, hook to silicone, keyhole insert, overmolding, insert molding, threaded attachment or adhesive, or any combination.

[0173] The connector may include a limited flow vent (or bias flow vent) to allow gas to escape from the interface. The vent may be in the form of a collection of small openings in the connector. The connector may include an internal funnel or extension that leads from the vent to the opening in the shroud. Alternatively, the connector may not include a bias flow vent.

[0174] An exemplary patient interface incorporating the inventions disclosed in this application is shown in Figures 1 and 2. For clarity, the patient interface is shown separated from the patient in Figure 2 and worn by the patient in Figure 1.

[0175] The patient interface 101 generally includes a mask 103, straps 104 for securing the mask to the patient, a flexible supply conduit 107 connected to the mask 103, and a conduit support structure 109 attached to the patient to support the weight of the conduit portion 107, with any connected conduits supplying gas to an inlet end 111 of the conduit portion 107.

[0176] Specific aspects of this patient interface and variations within each aspect are described with reference to other figures. An interface may incorporate some aspects while not incorporating others. For example, an interface may incorporate aspects of a mask while using a different structure to secure the mask to the user. An interface may include a different mask while using the inventive strap aspects to secure the mask to the user. An interface may incorporate aspects of a mask while not utilizing a similar or any structure to support the weight of the conduit from the patient's body. All of these variations are considered to be within the scope of this application.

[0177] Referring to Figure 1, a mask 103 is placed over the patient's nostrils and includes lateral sections that curve along either side of the nose. These lateral sections form a perimeter seal on the outward-facing surfaces of the nasal flanks. Straps 105 are passed around the user's head in simple loops above the user's ears.

[0178] The conduit portion 107 depends from a central connection 113 at the front of the mask 103. The central connection 113 is preferably a swivel elbow so that the path of the conduit relative to positioning the mask on the patient's face can be adapted to the patient's sleeping position. The swivel elbow may be in the form of a ball-and-socket joint so that the elbow can pivot about an axis parallel and perpendicular to its connection to the mask.

[0179] The illustrated conduit support 109 includes a collar 115 that is tethered around the neck of the user. A tether 117 connects between the collar and the conduit 107.

[0180] The components of this exemplary interface are shown in Figure 3. Mask 103 includes a seal 301 and a body or frame 303. The seal and body are shown in more detail in Figure 5A. Their engagement is described in more detail with reference to Figures 5A and 8.

[0181] The body 303 includes a receptacle 305 and a connector portion 307. The receptacle 305 receives an engagement portion 311 of an elbow 333. The elbow 333 is connected to an end of a length of flexible tubing 315. The other end of the flexible tubing 315 terminates in a cuff 317. The connector portion 307 of the mask body 303 is for engaging a connector portion 321 of the head strap 105. The head strap 105 has a single length 323 of stretchable material. The connector portions 321 are provided on both sides of the length 323.

[0182] The collar 115 includes a band 325 of material intended to be comfortable to wear while sleeping. The band includes a first adjustable connection portion 327 and a second non-adjustable connection portion 329. At the adjustable connection portion 327, the free ends of the band overlap, allowing the degree of overlap to be varied and secured to a desired amount. At the non-adjustable connection portion 329, the free ends of the band can simply be secured or released. Once the adjustable connection portion 327 is adjusted, the collar can be opened for fitting to a patient or removed from a client and secured after fitting to a client by disconnecting and connecting the non-adjustable connection portion 329. The non-adjustable connection portion 329 can be a quick-release connector that disconnects when tension is applied within a predetermined range. This ensures that the collar can be removed without injuring the patient in any difficult situations.

[0183] Tether 109 includes a first portion 331 attached to the collar and a second portion 333 attached to the conduit, which are preferably releasably engaged by a separate quick-release connector that preferably separates under tension within a predetermined range.

[0184] Tether portion 333 connects to conduit 315. Tether portion 333 includes a quick-release connector portion and a fitting 337 that engages the conduit. Fitting 337 may engage the corrugations of the conduit or recesses in cuff 317 as an open clip, or it may engage around the generally cylindrical shape of the conduit or the cylindrical portion of the cuff. Alternatively, as shown, portion 337 may include a ring that fits snugly over a portion of the conduit or a portion of the cuff. In the illustrated embodiment, ring 337 is disposed between cuff 317 and the connector portion of swivel 335. The ring fits over portion 339 of cuff 317 and is captured and retained by end portion 341 of swivel 335, which has a diameter larger than the inner diameter of the ring.

[0185] A preferred seal configuration is shown in Figures 4A-4C. Seal 301 includes a patient-facing side generally shown in Figure 4B and an outward-facing side generally shown in Figure 4A. A pair of nasal locators 401 protrude from the patient-facing side. Generally, the seal walls forming the patient-facing side are highly flexible, except for the nasal locators, the areas immediately adjacent the nasal locators, or both. The degree of flexibility is described in more detail with reference to the cross-sectional views shown in Figures 7D, 8, 9A, and 9B.

[0186] In its overall shape, the seal has a central portion that includes nasal locators on the patient-facing side and an opening 403 on the outer-facing side. The extent of this central portion 407 is roughly indicated in Figures 4C and 4A by dashed line 409. For clarity, dashed line 409 is also included in Figure 7A, which shows a top view of the mask portion of the interface.

[0187] Lateral or side portions 411 extend from central portion 407. Each side portion includes an outer surface 413, an inner surface 415, and a peripheral portion 417 joining the inner and outer surface portions. Peripheral portion 417 extends around a top edge 419, a terminal edge 423, and a bottom edge 420. Thus, when viewed from the inside of the seal, side portion 411 resembles a pocket.

[0188] Each side portion is fairly extensive. Preferably, the side portions extend more than 10 mm (most preferably more than 20 mm), or a distance at least 70% of the distance between the centers of the nostril locators 401 beyond the base of each nostril locator.

[0189] At least the inner wall 415 and outer wall 417 of each side portion are highly flexible so that they can conform to the contours of a user's face, particularly the outer contours of the sides of the user's nose. At least a portion of the outer walls 413 of the side portions are also flexible, but may become increasingly less flexible toward the central portion 407.

[0190] The central portion 407 of the seal includes an opening 403 to allow gas flow through to the mask body 303. The opening 403 may include lip and / or channel-like features that engage with channel and / or lip-like features in the body 303. The opening 403 may be formed by a clip portion, or a clip portion may be attached or overmolded around the opening 403 to facilitate engagement with the frame 303. Generally, the opening 403 is substantially thicker and more rigid than the flexible sealing portion of the seal 301. The opening 403 should be at least the size of the interior cross-section of the supply conduit 315. Preferably, as shown, the opening 403 is as large as the extent of the mask body 303, which is the same as the general width of the interface and approximately the width of the intended wearer's nose.

[0191] In a preferred form, the interface is intended to be compact, with the main body portion 303 of the mask curved to roughly follow the contours of the wearer's upper lip, and the seal is shaped so that the opening 403 follows this approximate curve in plan view.

[0192] A central portion 407 of the seal extends above and below the opening 403. Above the opening 403 and nostril locator 401, the central portion includes an outer surface wall 431, an inner surface wall 433, and a peripheral portion 435. At least the inner surface wall portion 433 and the outer surface portion 435 are preferably thin and flexible.

[0193] Beneath opening 403, central portion 407 includes outer wall portion 441, inner wall portion 443, and peripheral portion 445. At least inner portion 443 and peripheral portion 445 are preferably thin and flexible.

[0194] In use, the flexible inner wall portions above, below, and on either side of the nasal locator expand due to pressure within the seal (from the flow of gas supplied to the patient interface) and press against the wearer's skin, conforming to the contours of the outer surface of the wearer's nose, the surface of the lower aspect of the wearer's nose, and the surface of the wearer's upper lip immediately below the nose. The flexible perimeter or periphery of the seal allows the mask body to move at least slightly in the direction of travel so that movement of the mask body does not disrupt this seal. The flexible perimeter separates the position of the nostril locators from the position of the mask body, allowing the mask body to displace both laterally and vertically (relative to the axis of the patient's face). The side portions 411 engage the sides of the patient's nose and form some additional seal against them to support the position of the mask.

[0195] 5A, 5B, and 5C show the mask body and seal to a larger extent. As previously mentioned, the seal includes an opening 403 in a configuration that secures the seal to the mask body. The mask body includes a receptacle 502 for connecting to a supply conduit and a seal opening 501 for engaging with the seal opening 403. The seal opening 501 and the seal opening 403 include complementary features for engaging them. In the illustrated form, the seal opening 403 includes a lip and channel configuration 507, and the periphery of the seal opening 501 in the mask body includes a complementary channel and lip configuration 505. The channel and lip configuration is designed to ensure that the seal fits properly to the mask body and that there is no leakage from this joint when gas is supplied under pressure. Many other methods for connecting the seal and mask body can be devised, and this configuration is merely exemplary.

[0196] In the mask body, the outlet opening 501 to the seal is directly opposite the opening of the receptacle 502, so that the opening 502 is centrally located. Either side of the receptacle 502 extends to a central side portion 509. The central side portion 509 may be a flat covering wall that surrounds a portion of the opening 403 in the seal. The central side portion 509 may include a small opening as part of the gas release vent.

[0197] In the preferred embodiment shown, the side arms 511 extend beyond the seal opening 501, and as best seen in FIG. 7A, the side arms 511 preferably extend beyond the entire width of the seal. Each side arm 511 includes a connector portion 513 that connects to the strap connector portion 321. In the embodiment shown, the connector portion includes a fixed post with a notch around its periphery. The strap has a small loop formed at each end that extends over the fixed post and engages the notch. While this connector configuration is simple and intuitive, other connector configurations may be provided; for example, each side arm 511 could include a clip portion (e.g., a male or female portion).

[0198] As best seen in FIG. 7A, the side arm 511 emerges from the outer wall of the seal at an angle 713, for example, between 30° and 80°. The strap secured to the post 513 leaves the side arm at a position away from the seal and away from the wearer's face, as indicated by line 715 in FIG. 7A. This is indicated by the relative position of the tip 717 of the side arm 511 with respect to the center line 719 of the interface. The distance 721 from the center line to the tip of the side arm is preferably between 25 mm and 50 mm, and most preferably about 45 mm. Compare this to the distance 723 between the center line 719 and the central axis of the nose locator, which is preferably between 5 mm and 10 mm, and most preferably about 7 mm. Compare this to the approximate location of the inner wall of the side portion of the seal, away from the central portion of the seal. This position is indicated by dashed line 725 in FIG. 7A. Preferably, this distance 727 is between 10 mm and 20 mm, and most preferably about 15 mm. For further comparison, the outermost extent of the side portions is indicated by dashed line 729. The distance 731 of dashed line 729 from center line 719 is preferably between 15 mm and 30 mm, and most preferably about 25 mm.

[0199] In the front-to-back direction, the tip 717 is preferably posterior to the base of the nose locator so that the base of the nose locator is between the central portion of the mask body and a line connecting the tip 717 .

[0200] 7A, generally, the widest outer extent 741 of the mask seal may be between 30 mm and 60 mm, most preferably about 50 mm. The total depth 743 of the seal and mask frame may be preferably between 40 mm and 65 mm, most preferably about 55 mm. Within this depth, the interior space defined by the seal that encases the user's nose in use may have a depth 745 that is preferably between 20 mm and 40 mm, most preferably about 30 mm.

[0201] As can be seen in Figure 7A, the seal has a significant arcuate curve in its overall shape, with the side portions generally parallel to one another and facing across the nose-accommodating space. The orientation planes of the side portions may be at an angle between 0° and 45°, preferably between 0° and 25°. As shown in Figures 9A and 9B, this is preferably true for both the inner and outer walls. This is also preferably true for substantially all levels vertically displaced within the seal, as illustrated by the different levels shown in Figures 9A and 9B.

[0202] As shown in Figure 7A, the general planar configuration of the seal may be considered parabolic, semi-elliptical, semi-oval, or U-shaped. Generally, a central portion of the seal defines a width of the seal, and side portions of the seal extend away from outer edges of the central portion in directions substantially parallel to one another and substantially perpendicular to the width direction.

[0203] 5B and 5C also show the connection of swivel elbow 313 to mask body 303. Swivel elbow 313 includes a ball portion 515 and an opening 517. The outer surface of ball portion 515 is preferably a frustospherical surface, but can be modified to still achieve a near seal with receptacle 502. Similarly, receptacle 502 is preferably a frustospherical surface with a slightly recessed lip. This can best be seen in FIG. 8, where lip 802 is slightly recessed relative to the remainder of receptacle 502.

[0204] The swivel elbow 313 preferably defines an angle between the conduit flow and the connection to the mask of between 0° and 90°, preferably between 30° and 60°, and most preferably about 45°. The elbow may incorporate an aperture 519 which forms part or all of the gas relief vent for the patient interface. The aperture is preferably located outside the bend in the elbow, substantially in the line of the gas flow path away from the mask.

[0205] 5B and 5C also show connector portions 321 of the straps engaged with posts 513 on the mask body.

[0206] 7A-7D provide background for the cross-sectional views shown in FIGS. 8, 7D, 9A and 9B.

[0207] Figure 7D is a cross-section of the seal of Figure 7C taken along line EE. Figure 7D shows the thickness of the seal portion at the vertical center plane of the seal. This illustrates the thickened seal in the region 731 immediately adjacent to and between the nostril locators. The cross-section also illustrates the thickened seal at outer wall portion 431 of the seal's central portion above outlet 403, and at outer wall portion 441 of the seal's central portion below opening 403. These thickened sections preferably progressively thicken from thin, flexible peripheral portions 435 and 445, each approximately 2 mm to 4 mm thick. The flexible wall portions, peripheral portions 435 and 445 and lower and upper inner wall portions 443 and 433, preferably have wall thicknesses of 0.05 mm to 0.5 mm, and most preferably 0.1 mm to 0.2 mm.

[0208] The portion 731 between the nose locators preferably has a thickness of 2 mm to 0.5 mm, preferably 0.8 mm to 1 mm.

[0209] These dimensions are given for a silicone material having a Shore A hardness of about 40. If the seal is formed of other materials, equivalent alternative dimensions may be contemplated, while maintaining flexibility of the cover in the preferred flexible areas and sufficient hardness to impart shape to the cover in the shape-imparting areas.

[0210] Figure 8 is a cross-section taken along DD of the mask seal and body of Figure 7A. This shows a cross-section of the central portion of the seal on the outwardly facing side as shown, as already described with reference to Figure 7D to show the connection of the seal opening to the opening in the mask body. However, the cross-section of Figure 8 also shows a preferred cross-sectional form of the 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, most preferably between 0.8 mm and 1 mm.

[0211] The nasal locator includes a base portion 808 and a nozzle portion 810 with a central opening 812. The portion including the opening 812 fits inside the user's nostril. The base portion 808 provides a primary location for the entrance to the nostril.

[0212] Figure 9A is a cross-section of the seal taken along line GG in Figure 7D. This is a cross-section of the seal in an approximately horizontal mid-plane through the nostril locators. This cross-section shows that the wall portions 806 of the nostril locators, the regions 902 immediately adjacent the outer periphery of the nostril locators, and the central portion 731 between the nostril locators all have thickened walls compared to the flexible wall portions 415 and 423 of the side portions of the seal. In particular, the regions immediately adjacent to and including the nostril locators preferably have a thickness of 0.5 mm to 2 mm, and most preferably 0.8 mm to 1 mm.

[0213] The outer wall portions 413 of the side portions of the seal are also substantially thicker than the portions adjacent the nostril locators. These portions preferably have a thickness of 2 mm to 5 mm, most preferably 3 mm to 5 mm. These portions taper to a flexible thickness where they become the peripheral portions 423.

[0214] The thickened portion of the outer wall 413 of the side portion preferably extends to within 10 mm of the outermost tip of the side portion.

[0215] The thickness and stiffness of these outer side portions 413 give the seal substantial form and stability in place: the side walls resist outward flexing of the side portions of the seal as the seal expands under pressure from the supply, while the wall portions 413 flex outward under pressure and have sufficient reaction force to keep the seal wrapped around the wearer's nose.

[0216] The stiffness provided by the thickened region of the seal can be provided by a composite material or a combination of parts. For example, stiffness can be provided by silicone reinforcement or by a flexible insert of stiff material. The insert of stiff material can be integral with the mask body. Preferably, the side portions of the seal are configured to resist bending by an effective stiffness of at least 1 N force at the end of the stiffened region for bending of the side portions through an angle of about 60°.

[0217] Figure 9B shows another substantially horizontal plane above the cross section of Figure 9A. This cross section is taken along line FF in Figure 7D. It also shows the thickness of outer wall portion 413 of the side portions of the seal relative to inner wall portion 415 and peripheral portion 423 and relative to the thickness of upper inner wall portion 433.

[0218] Again, side portion 413 preferably has a thickness of 2 mm to 5 mm, most preferably 5 mm to 3 mm. Flexible portions 415, 423 and 433 have a thickness of 0.05 mm to 0.5 mm, most preferably 0.1 mm to 0.2 mm.

[0219] Figures 10A-10C are perspective views of a patient interface incorporating several of the inventions described herein: Figure 10A is a front view, Figure 10B is a side view, and Figure 10C is a rear view.

[0220] The interface 1000 is similar to the interface described with reference to Figures 1-3. The seal 1010 shares many similarities with the seal of Figure 4. The frame assembly 1008 shares some of the same features as the frame 303 of Figure 5. Like the interface of Figures 1-3, the interface 1000 has a short, depending conduit coupled to the frame assembly 1008 by a ball-and-socket or swivel connection. Also like the interface of Figures 1-3, the interface is preferably secured to the wearer's head by a single loop strap. This loop strap may be made of materials described later in this specification. The frame assembly may also include a lip stabilizer, as described with reference to Figures 58-61.

[0221] 10A-10C, the overall configuration of the interface 1000 includes a frame assembly 1008 and a seal 1010 inside the frame assembly. A supply conduit 1004 depends from the frame assembly to supply gas to the frame assembly and from there to the seal. Headgear 1002 is connected to the frame assembly to secure the interface to the user's head.

[0222] The frame assembly includes side portions 1016. As with the assembly of Figure 5, the side portions may extend away from the outer wall of the seal (and therefore away from the wearer's face in use). At least one, and preferably both, of the side portions 1016 provide connection for the connectors 1014 of the headgear 1002.

[0223] Connectors 1014 are connected to terminate the ends of strap 1012. Preferably, each end of strap 1012 includes a connector, and each side portion 1016 includes a matching cooperating connection.

[0224] The supply section preferably includes a short length of flexible tubing 1026 , a supply connector 1022 and an interface connector 1006 .

[0225] The tube 1026 can take many forms. For example, the tube 1026 can be a stretchable conduit, a short elastic conduit that is normally in a relaxed state, an extruded serpentine tube, or a wound tape tube with spiral ribs. The tube should be resistant to crushing and allow for a wide range of lateral turns and bending. The length of the tube is preferably between 50 mm and 150 mm.

[0226] The interface connector may include a bias flow vent. However, in the illustrated interface, the connector does not include a bias flow vent. The connector 1006 preferably includes a portion of a swivel joint 1020 to the frame assembly 1008. The connector preferably includes a portion of a ball-and-socket or swivel joint, and most preferably includes an elongated hollow plug portion that extends to a receptacle in the frame assembly.

[0227] 10B, the connector preferably redirects the supply flow at an angle between 25 and 75 degrees. Most preferably, the connector redirects the flow at an angle between 40 and 60 degrees. This angle, combined with the angle of the front of the frame assembly immediately surrounding fitting 1020 (e.g., relative to the wearer's frontal plane), allows tubing 1026 to easily drape below the interface (when the user is upright) and remain close to the user when the user is lying down, keeping fitting 1020 close to the patient.

[0228] The supply connector 1022 preferably includes a swivel.

[0229] The frame assembly 1008 preferably includes a bias flow vent 1018. The bias flow vent 1018 may include at least a flow path from the interior of the interface to the ambient environment. An interface may be provided for use with a return flow type vent that does not include a bias flow vent at all.

[0230] If a bias flow vent is included, it may include at least one aperture extending through the wall defining the frame assembly. In the illustrated interface, the bias flow vent 1018 includes multiple apertures. The apertures are positioned to direct the exit flow of gas primarily upward relative to the wearer's head. By primarily upward, it is meant that the gas is directed in a direction parallel to the plane of the face (or frontal plane) rather than perpendicular to the plane of the face, and generally toward the forehead.

[0231] As best seen in FIG. 10C, the frame assembly may include a depending support portion 1024 that extends below the seal 1010. The depending support portion includes a pad 1030 to provide support to the wearer's upper lip area near the nasolabial fold. For some users, the pad 1030 may extend to the lower cheek area immediately adjacent the nasolabial fold. The pad only contacts the face when needed to support the seal. This aspect of the interface is covered in detail with reference to FIGS. 18-61.

[0232] 10C also shows that the seal includes a pair of nasal locators 1036. Each nasal locator includes an opening, and the nasal locators are positioned within the wearer's nostrils during use. The nasal locators extend from a flexible inner wall portion 1042 of the seal.

[0233] In the illustrated interface, each nasal locator includes a generally tubular nozzle portion 1040 and a convex base portion 1038. The generally tubular nozzle portion 1040 may be slightly tapered toward the open end. The convex base portion may be considered dome-shaped.

[0234] In some embodiments, the convex base portion extends around the entire periphery of the locator and surrounds the tubular nozzle portion. In other embodiments, the convex base portion may extend around most, but not all, of the periphery of the locator. For example, the base portion may extend continuously around 60% or more of the periphery of the locator.

[0235] Both the nozzle and base portions of each locator are preferably oval or elliptical in cross section, as shown in more detail in Figures 11E-11H.

[0236] Figures 11A-11H are views of the soft seal component of the interface of Figures 10A-10C. Figure 11A is a top view. Figure 11B is a front view. Figure 11C is a rear view taken from a position directly facing the open end of the nasal locator. Figure 11D is a cross-sectional view through section CC of Figure 11C.

[0237] These drawings show many similarities to the seal of Figure 4. The utility and function of similar features will not be repeated in detail.

[0238] In general terms, a seal includes an inwardly facing wall portion and an outwardly facing wall portion. The inwardly facing wall portion forms a seal against the surface of the wearer's face. The outwardly facing wall portion connects the seal to the frame assembly and supports the overall shape of the seal. Like the seal of FIG. 4, the overall shape of the seal is U-shaped or V-shaped, with side portions extending rearward from a central transverse portion.

[0239] The outwardly facing portion includes side portions 1032, which are larger in cross section than the inwardly facing wall. The inwardly facing wall includes a nose locator supported on a generally flexible back portion 1052. A flexible perimeter 1034, 1044 connects the outwardly facing wall and the inwardly facing wall around the periphery.

[0240] 11A and 11D, each nasal locator preferably includes a tubular portion 1042 and a dome-shaped portion 1038. Each tubular portion further terminates in a rim 1042 that defines an opening 1050.

[0241] The tubular portion tapers toward the opening 1050. The taper is preferably a linear taper. Alternatively, the taper may be a curved taper. The surfaces of the dome-shaped portion and the tubular portion form an obtuse included angle, for example, between 120 and 160 degrees.

[0242] The cross section of FIG. 11D presents tubular portion 1042 as approximately frusto conical and dome-shaped portion 1038 as approximately frusto spherical. However, in either case, the alternative cross sections (FIGS. 11F-11H) are ellipsoidal rather than circular. Therefore, the dome shape may be considered an ellipsoid. The tubular portion shape may be considered an elliptical cone. However, in either case, the shapes need not be true ellipses but instead include shapes less than regular ellipses; the dome shape may be considered an ovoid or ovoid dome, and the tube shape may be considered an ovoid or ovoid cone, or a tapered ovoid or ovoid tube.

[0243] The tubular portions of the nasal locator are spaced apart but aligned so that their axes substantially converge, preferably at a distance of 10 mm to 40 mm from the opening of the nasal locator.

[0244] The domed portions of the nasal locators meet around or meet at a cleft 1046 at the centerline of the seal. Preferably, cleft 1046 is shaped to give one nasal locator dome some freedom of movement relative to the dome of the other nasal locator.

[0245] 11E-11H, the oval cross-section of each nasal locator is shown in detail. In particular, three cross-sections of the nasal locator are shown. These cross-sections are taken in a plane parallel to the plane of the opening at the open end of the nasal locator.

[0246] These cross sections reveal an oval shape. In particular, the oval or ellipse of opening 1050 has an aspect ratio of approximately 1.8 to 1. The major axis of the oval or ellipse is more than twice the minor axis, and preferably 1.5 to 3 times the minor axis.

[0247] The oval shape is maintained throughout the tubular and domed portions of the nasal locator. However, in the illustrated seal, the absolute difference between the major and minor axes is maintained, not the ratio. Thus, the ratio decreases as you move from the shape of the opening 1050 to a first cross section 1054 spaced away from the base of the tubular portion. The ratio further decreases as you move from cross section 1054 to cross section 1056 at the midpoint of the domed portion. The ratio further decreases as you move from cross section 1056 to cross section 1058 at the base of the domed portion.

[0248] For example, the tip opening may have a major axis dimension of about 9 mm and a minor axis dimension of about 5 mm. The cross section of the tubular portion at the EE may have a major axis dimension of about 13 mm and a minor axis dimension of about 9 mm.

[0249] For the domed portion in GG, the major axis dimension may be approximately 18 mm and the minor axis dimension may be approximately 15 mm.

[0250] For the domed portion of the HH, the major axis dimension may be approximately 22 mm and the minor axis dimension may be approximately 18 mm.

[0251] As best shown in Figure 10C, the nose locator ovals are preferably not aligned parallel when viewed from the rear of the interface. In particular, the upper ends of the ovals are closer together than the lower ends. When projected rearward in the frontal plane of a hypothetical wearer, the major axes of the ovals form an angle of 60 to 120 degrees.

[0252] Each nasal locator preferably includes a lip 1042 at its open end 1050. The material at the lip 1042 is preferably thicker than the material in the remainder of the tubular portion or in the area of ​​the tubular portion immediately adjacent the lip. The thickened lip provides a slightly more positive form to the end of the locator when placing the locator in the wearer's nostril. This can help the end of the locator feel more comfortable to the wearer when wearing the interface.

[0253] 11B and 11E also show features of the seal that are included when securing the seal to the frame assembly. As can be seen in FIG. 11B, the outwardly facing portion of the seal includes a main opening for securing with the frame assembly. The main opening includes a lip 1048 that extends around the perimeter of the opening. The lip may be comprised of a thickened region of the outer wall of the seal. For example, the lower portion of the lip is shown in cross section in FIG. 11E.

[0254] Markers or features may be provided on the lip at one or more locations to ensure proper assembly of the seal to the frame assembly. The seal shown and described is sensitive to incorrect assembly. In this embodiment, the seal is removably positioned from the frame.

[0255] The lip preferably includes a protrusion for easy positioning, which engages in a notch in the frame when the seal is in place. The lip may include a protrusion 1046 extending in either or both an inward and outward direction. In the illustrated embodiment, two protrusions 1046 are provided, which engage in notches 1074 and 1092 in the frame.

[0256] The lip of the seal generally takes the form of a bent oval. By this we mean an oval that is bent so that the ends of the oval curve away from a plane tangent to the central portion of the oval. This can generally be seen from the configuration of the outer wall portion of the seal in Figure 11A.

[0257] 12A-12H are views of the frame assembly of the interface of FIGS. 10A-10C. FIG. 12A is a front perspective view of the frame assembly. FIG. 12B is a rear perspective view of the frame assembly. FIG. 12C is a side view of the frame assembly. FIG. 12D is an assembly view of two components of the frame assembly. FIG. 12E is a rear view of the frame assembly.

[0258] Figure 121 is a rear view of a slightly differently configured frame assembly without the stabilizer portion, showing an alternative configuration of the channel for securing the seal. Otherwise, the frame assembly can be formed and assembled in substantially the same manner as the frame assemblies of Figures 12A-12H.

[0259] The frame assembly 1008 includes two main components: a first component 1070 and a cover 1060 .

[0260] The two components of the frame assembly fit together to provide a channel 1096 for securing the lip 1048 of the seal.

[0261] The first component 1070 may include a first portion of the channel, while the cover 1060 provides a second portion of the channel. The component 1070 may provide an inner flange portion 1072, and the cover may provide an outer flange portion 1094. A base portion for the channel may be provided extending from the flange portion of either component. For example, a base portion 1088 may be provided from the flange portion 1072.

[0262] Flange portion 1072 may include a notch 1074 to accommodate a locating feature on the seal lip 1048. Flange portion 1094 may include a notch 1092 to accommodate an additional locating feature on the seal lip.

[0263] In accordance with a preferred form of the seal and channel, the channel has a generally outward flare such that the portions of the channel on either side of the main opening widen toward each other as they progress from the base of the channel to the open edge of the channel. Thus, the lip of the seal is pulled past the inner flange portion 1072 and the seal is held in the channel by the elastic tension of the lip.

[0264] In the frame assembly of Figures 12A-12H, the channel generally forms a curved oval. In the example of Figure 12I, the channel follows a path similar to a curved rounded rectangle or trapezoid. Notably, the overall path of the channel is not as wide as that of the embodiment of Figures 12A-12H. Furthermore, the channel includes relatively straight side portions 1220. The side portions 1220 narrow slightly as they extend toward the bottom portion 1226 and widen slightly as they extend toward the top portion 1217. While this assembly maintains the overall shape of a curved oval, the straight side portions have been found to improve ease of assembly compared to the sharply curved end portions of the curved oval of Figures 12A-12H.

[0265] The alignment of the notch and protrusion is preferably provided adjacent the top or bottom of the channel, most preferably adjacent the top of the channel, so that the lip 1048 can be placed in the channel in the correct position and then the remainder of the lip can be pulled over the inner flange portion 1072.

[0266] The first component 1070 may include an extension for carrying the support pad 1030. For example, the lower shielding portion may curve and extend below the feed opening of the interface. The lower shielding portion may include side portions, on the lower inner surfaces of which the pad 1030 is provided.

[0267] The inner surface 1078 of the top of the shield wraps around the side of the interface and is positioned adjacent the outside of the outer wall of the seal. The top of the shield may help maintain the seal's shape by restricting outward deflection of the outside of the seal cover under internal gas pressure.

[0268] The first component may carry a portion of the swivel connection 1020. Preferably, the first component 1070 includes a ring portion 1080 that is open at the front and back. The ring portion preferably includes a surface that mates with a surface of the feeding tube connector.

[0269] Preferably, ring portion 1080 includes an inwardly facing, substantially spherical surface 1084. Inwardly facing surface 1084 may mate with a complementary outwardly facing surface of a spherical portion of a supply tube connector. The spherical portion of the supply tube connector may have an internal passageway that directs gas from the supply tube through ring portion 1080.

[0270] One advantage of this arrangement is improved material options. The supply tube connector is preferably made from a different base polymer material than the ring portion 1080 of the component 1070. Different polymer materials working together tend to reduce friction and noise more than polymers of the same base material. Additionally, the outer cover 1060 can be formed from the same material as the supply tube connector, providing an aesthetically pleasing appearance.

[0271] For example, the ring portion of component 1070 may be formed from a material selected for its strength and toughness, such as polycarbonate plastic, and the cover 1060 and supply tube connector may be formed from a plastic selected primarily for its finish and appearance, such as acetal plastic, which may include a lubricious copolymer, such as PTFE (polytetrafluoroethylene).

[0272] The ring portion 1080 also provides a feature for securing the two components 1060 and 1070 together.

[0273] For example, the outer surface of ring portion 1080 may include outwardly facing features such as recesses or channels 1082 to cooperate with inwardly facing clips or inwardly facing annular ridges 1087 around perimeter 1066 of opening 1068 in cover 1060. This is best seen in cross section in FIG. 12G.

[0274] The periphery of cover 1060 may be integral with a portion of the surface of component 1070. For example, a lower curved edge of cover 1060 may abut an upper curved edge of a lower shielding portion of component 1070. This is shown at 1081 in Figure 12G. A similar abutting edge on a side portion is shown at 1081 in Figure 12H.

[0275] Components 1060 and 1070 may form an outlet plenum adjacent bias flow vent 1018. This is best understood by considering the exploded view in Figure 12D, the rear view in Figure 12B, and the cross sections in Figures 12G and 12H. A plenum 1079 is defined between curved oblong frame portion 1072 of component 1070 and the interior surface of cover 1060, near aperture 1068.

[0276] Openings 1086 to the plenum 1079 are defined by the rear edge of the ring portion 1080 and the oval frame portion 1073. Gas flowing from the seal to the bias flow vent passes through these openings. The inner surface 1098 of the flange 1072 of the oval frame 1073 preferably defines a flow directing surface that narrows toward the plenum, acting like a funnel.

[0277] The bias flow vent 1018 has an opening leading from a plenum 1079 .

[0278] The ring portion 1080 opens essentially centrally through the oblong frame portion 1073. This essentially splits the flow to and from the seal immediately adjacent the open end of the seal.

[0279] The ring portion may be supported in this position by one or more support struts 1076 or by the areas at the top and bottom where the ring and oblong frame portions come together.

[0280] The bias diversion holes 1097 are curved around the top 1089 of the plenum chamber 1079. This top is fairly confined to the location shown in FIG. 12G, just above the ring portion 1080, but is more open on both sides.

[0281] The biased diverting holes may be located in the shelf portion 1099 of the wall of the cover 1060 to provide an upward exit flow (generally parallel to the wearer's frontal plane).

[0282] The lower shielding portion of the component 1060 may include a soft covering 1085, such as an overmolded layer of a soft, biocompatible material, that covers a more rigid skeleton or frame 1083. Suitable coverings may be, for example, thermoplastic elastomers, polyurethane foams, or silicone elastomers. The skeleton or frame 1083 of the component 1060 may be formed from a copolymer that includes an amount of plastic material that provides a strong bond with the covering material. For example, the frame 1083 may be formed from a polycarbonate-siloxane copolymer. The siloxane contributes chemical resistance and improves the bonding of the overmolded silicone cover.

[0283] Distal side portions 1016 of the cover 1060 extend from the outer surface of the shielding portion of the component 1070. The side portions 1016 provide receptacles 1062 for receiving connectors of headgear straps.

[0284] 13-20 show another embodiment of an interface with an enveloping inflatable seal. The interface 1100 includes a seal body 1101 and a frame 1102.

[0285] Attached to the frame 1102 is a tube 1112 that is attached to a gas supply. The tube delivers gas to the mask frame and seal. The tube 1112 may be tethered to a user (wearing the interface 1100) by a lanyard 1113. In use, the lanyard 1113 extends around the user's neck. The lanyard 1113 may be attached to the tube by any known method, but shown is a c-shaped clip 1114 attached to the lanyard 1113 that grips the tube.

[0286] The interface 1100 is held in place over the user's nose by a head strap 1114. The strap is preferably made of a flexible type material such as silicone or a laminate material well known in the art of headgear straps. Each end of the strap 1114 is attached to a clip 1116 which is preferably attached to a corresponding eyelet 1117 formed in or attached to the seal body 1101. The strap may be a flat molded silicone strap, a small hollow silicone tube, or any suitable configuration known in the art.

[0287] A plurality of bias diversion holes 1115 may be formed in the frame 1102 to allow exhaled gases from the user to escape from the interface. Alternatively, bias diversion holes may be formed in the seal body 1101 to allow gases to escape.

[0288] The seal body 1101 is again a flexible or inflatable seal. The seal body 1101 is curved in shape to conform to the contours of a human face and extend around and encase the user's nose. The seal body 1101 preferably extends completely to the sides of the user's nose and may extend partially to the user's cheeks. The seal 1101 includes an inner wall with an inner surface 1103 and an outer wall with an outer surface 1104. Nasal locators 1105 and 1106, each with an outlet 1107 and 1108, project from the inner surface 1103.

[0289] Similar to the embodiment of FIGS. 10-12, the seal body 1101 includes an inlet opening 1109 opposite the nasal locators 1105, 1106 to receive the frame 1102.

[0290] The seal 1101 has a variable wall thickness, allowing it to be rigid around the protruding part of the seal and flexible between the nasal locators 1105, 1106 and the periphery 1110 of the seal's inlet opening 1109. This means that there is a decoupling effect between the mask frame 1102 and the nasal locators 1105, 1106 and the inlet periphery 1110. This means that the mask frame is able to move some without breaking the seal of the nasal locators 1105, 1106 with the user's nares.

[0291] 18, the inlet perimeter 1110, which defines the gas inlet 1105 to the seal, has a substantially thick cross-section. This provides rigidity to the inlet perimeter 1110. Similarly, the nasal locators 1105, 1106 have a substantially thick cross-section. However, the thickness of the nasal locators need not necessarily be as thick or thicker than the inlet perimeter 1110. In a preferred form, the thickness of the nasal locators is less than the thickness of the inlet perimeter.

[0292] The region between the inlet perimeter 1110 and the nasal locators 1105, 1106 is preferably thinner in cross section than both the nose location and the inlet perimeter. For example, in FIG. 18 , the length of seal 1101 between X and Y is formed to be substantially thinner in cross section than either the inlet perimeter or the nasal locators. This means that this length is more flexible and can more effectively move the nasal locators 1105, 1106. Furthermore, because the length between X and Y, including the outer perimeter 1111, is thinner in cross section, the seal expands more easily, assisting in sealing the seal around the user's nose.

[0293] As can be seen in Figure 18, preferably a region 1118 of the cover adjacent the base or bottom of each nasal locator has a thickened cross-section. As shown, preferably a length or region 1119 of the seal between region 1118 and the thickened inlet perimeter 1110 is formed to be substantially thinner in cross-section than either the inlet perimeter 1110, the nasal locators 1105, 1106 or region 1118.

[0294] In an alternative embodiment, the covering includes a thickened region 1118 adjacent the base of the nasal locators, and the cross-sectional thickness of the nasal locators is not thickened. For example, the cross-sectional thickness of the nasal locators may be similar to the thickness of the covering region 1119 extending between the region 1118 adjacent the nasal locators and the inlet perimeter 1110. The thickened region 1118 adjacent the base of the nasal locators prevents the base of the nasal locators from excessively deforming or expanding under typical CPAP pressures. However, the thin walls of the nasal locators 1105, 1106 in this embodiment may bulge under CPAP pressures.

[0295] Preferably, the seal 1101 is formed from silicone having a Shore A hardness of about 40. Alternatively, other materials with similar properties may be used. For a 40 Shore A silicone, or other material with similar properties, the thickness of the cover region 1119 extending between the nose locator and the inlet periphery is less than about 0.5 mm. Preferably, the thickness of this region 1119 is between 0.1 mm and 0.2 mm. Alternatively, this region 1119 of the cover may have a thickness of less than 0.1 mm, for example 0.05 mm.

[0296] The thickness of the region 1118 adjacent the base of the nose locator preferably has a thickness of less than 2 mm. Preferably, the thickness of the region 1118 adjacent the base of the nose locator is between about 0.8 mm and 1.0 mm. Alternatively, the thickness of the region 1118 adjacent the base of the nose locator may be less than 0.8 mm, for example 0.5 mm.

[0297] The thickness of the region adjacent the inlet periphery may be about 3mm to 5mm, but may be less, for example 2mm.

[0298] The thickness of the nose locator is less than 2 mm. In a preferred embodiment, the thickness of the nose locator is about 0.8 mm to 1.0 mm. Alternatively, the thickness of the nose locator is less than 0.8 mm, for example, 0.5 mm.

[0299] In the alternative embodiment described above, the thickness of the nose locator is similar to the thickness of the covering region 1119 extending between the nose locator and the inlet periphery. In this embodiment, the nose locator has a preferred thickness of about 0.1 mm to 0.2 mm. Alternatively, the thickness of the nose locator may be less than 0.2 mm, for example 0.05 mm.

[0300] Preferably, the change in thickness from one region of the seal to another occurs gradually. For example, the thickness of the seal gradually changes from thickened portion 1118 to thinned portion 1119. Similarly, the thickness of the seal gradually changes from thickened portion 1110 to thinned portion 1119.

[0301] Referring now to FIG. 20 , a cross section of the seal 1101 taken along line AA of FIG. 16 is shown. This view shows an alternative view of the seal 1101 illustrating variations in thickness of portions of the seal. In particular, the inlet periphery 1110 and nasal locators 1106, 1108 are thicker in cross section compared to the outer periphery 1111. At least laterally, the thickened region 1110 adjacent the inlet extends at least half the distance from the inlet to the outer peripheral edge 1121. In an upward direction, the thickened region extends at least half the distance from the inlet to the upper peripheral edge 1123. In a downward direction, the thickened region extends at least half the distance to the lower surface portion 1125. The portions of the seal between the nasal locators 1106 and 1107, generally designated 1112, are also thicker in cross section, providing additional stability to the nasal locators in these regions.

[0302] 21 shows an alternative embodiment of the seal, in which the region between the nasal locators, designated 1113, is substantially thinner in cross section than the inlet perimeter 1110 and the nasal locators 1106, 1108. This configuration provides additional flexibility between the nasal locators 1106 and 1108.

[0303] Figure 22 shows yet another embodiment of the seal of the present invention. Here, the seal is inflatable, but extends downward to seal against the user's mouth in use. This seal 1200 includes nose locators 1201, 1202 and is received in a frame similar to that described in any of the previous embodiments. Seal 1200 has an extension 1203 that covers the user's mouth, forming a seal to reduce mouth leakage.

[0304] Figure 23 shows another embodiment of the seal of the present invention. This seal 1300 has the same shape as the seal of Figure 22, with nasal locators 1301, 1302 and an extension 1203 that covers the mouth, but includes an outlet 1304 that is directed towards the user's mouth, allowing gas to be delivered simultaneously through the user's mouth and nasal locators 1301, 1302 to the user's nasal passages.

[0305] 24-29 show various head straps that may be used with any of the interface embodiments described herein.

[0306] Figure 24 shows a single head strap 1402 attached to an interface 1400, and in particular to a flexible and inflatable seal 1401, by any suitable means known in the art of interfaces and head straps. The strap 1402 may be a hollow tube 1402 as shown in Figure 24a or a solid tube 1402' as shown in Figure 24b. The hollow tube may be, for example, an elongated silicone tubing having a diameter of 3mm to 6mm and a wall thickness of 0.2mm to 1mm.

[0307] Figure 25 shows a single head strap 1410 attached to the interface 1400, and in particular to the flexible and inflatable seal 1401, by any suitable means known in the art of interfaces and head straps. The strap 1410 may be an elongated hollow tube 1410 as shown in Figure 25a or an elongated solid tube 1410' as shown in Figure 25b. The strap is preferably narrow at its ends 1411, 1412 where it is attached to the seal 1401, and wider at a midpoint that rests behind the user's head in use.

[0308] 26 shows a dual 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 attaches to the seal 1401.

[0309] Figures 27 and 27a show an extensible head strap 1430 attached to the interface 1400. The strap 1430 has an elastic section 1431 that allows the strap to better fit the user's head.

[0310] 28 shows an alternative head strap 1440 attached to the interface 1400, and in particular to the seal 1401. The head strap 1440 preferably includes side straps 1441 having rigid sections 1442, 1443 to provide additional stability to the side straps 1441. The head strap 1440 also preferably includes top straps 1444 and rear straps 1445 that extend over the head or behind the head, respectively. This head strap is described in detail in U.S. Patent Application No. 12 / 307,993 to Fisher and Paykel Healthcare, the contents of which are incorporated herein by reference.

[0311] 29 and 29a show yet another alternative head strap 1450 attached to the interface 1400, and in particular to the seal 1401. The head strap 1450 is curved and has a septum 1451 that provides additional support or stiffness to the strap.

[0312] The head straps described above may be made of any suitable material, such as soft plastic, silicone, laminated fabric, or other suitable material.

[0313] Figures 30-33 show various ways in which an interface frame can be attached to an expandable seal body. In Figure 30, seal body 1500 includes overmolded or bonded hard plastic barbs 1502. Barbs 1502 clip into correspondingly shaped recesses 1503 formed in frame 1501 and hold seal body 1500 in sealing engagement with frame 1501.

[0314] Similarly, in Figure 31, seal body 1500 has a perimeter 1512 formed with an overmolded or bonded hard plastic loop clip 1513 that fastens to frame 1501. Details of such clip mechanisms are described in U.S. Patent Application No. 12 / 502,528 to Fisher and Paykel Healthcare, the contents of which are incorporated herein by reference.

[0315] 32, the seal body 1500 may have an inlet 1522 that has a stretchable interference fit around a frame 1501. The frame preferably has a groove 1523 and a raised lip 1524 to allow the inlet 1522 to engage with the frame.

[0316] In another alternative form, as shown in FIG. 33, the seal body 1500 may be permanently attached to the frame 1501 by overmolding or bonding.

[0317] 34-40 illustrate various ways in which the tubing (1112, see FIG. 13) extending from the interface 1100 can be secured to the user. The advantage of securing the tubing to the user is that it removes the weight of the tubing from the interface, reducing the likelihood of the interface being pulled from the user's face. Each of the braces described below is preferably made from fabric straps. The fabric is preferably a breathable type of material, although other suitable fabrics may be used. In all configurations described herein, the tubing is attached to the brace by clips or pins.

[0318] FIG. 34 shows a brace 1600 made from looped fabric straps that, in use, are placed around the user's head and one shoulder.

[0319] 35 shows an alternative brace 1610. This brace is also preferably made of fabric that is shaped to cross over the center of the user's chest and fastened securely around each of the user's arms.

[0320] 36 shows another alternative brace 1620. Here, the brace 1620 has straps that cross over the center of the user's chest but fasten securely around the user's neck and back.

[0321] Alternatively, as shown in FIG. 37, a brace 1630 can be used to secure the tube to the user, the brace being formed from looped straps that extend around the chest and under the user's arms.

[0322] As shown in FIG. 38 or FIG. 39, the brace 1640 may additionally include two shoulder straps 1641, 1642 or just one shoulder strap 1643.

[0323] Alternatively, as shown in Figure 40, the interface of the present invention may employ a simple brace 1650 that simply fits over the user's shoulder or upper arm during use.

[0324] Additional tube support configurations are described with reference to Figures 41-57. Figures 41-51 illustrate support collars that may support a tube with a tether for wearing around a user's neck. Figures 52-55 illustrate embodiments of tethers that may be used with such collars or with other configurations for securing one end of the tether to a patient. Figures 56 and 57 show two such configurations for securing the tether to a patient. Figures 34-40 illustrate other configurations for securing such tethers to a patient.

[0325] FIGS. 41-45 illustrate in more detail the collar generally described above in connection with FIGS. 1-3. The collar includes an adjustable connection portion 327 and a secondary connection portion 329. The adjustable connection portion operates between the first end 4100 and the second end 4102 of the collar. The adjustable connection portion 327 allows the user to set the amount of overlap between the ends 4100 and 4102. FIGS. 41-45 show the adjustable connection portion 327 in the form of a dome-style fastening device. A fastening portion 4104 is attached to the first strap end 4100. A number of complementary fastening portions 4106 are spaced along the second strap end 4102. The overlap of the end 4100 relative to the end 4102 is set by engaging the fastener 4104 with one of the series of fastening portions 4106. The fastening portions 4106 may be spaced 2 cm to 5 cm apart, preferably 3 cm to 4 cm apart. This results in a difference in the circumference of the collar of 3 to 4 cm.

[0326] Preferably, the outer overlapping end 4100 includes a single connector portion, and the inner strap end includes a series of outwardly facing second connector portions. With this configuration, no connector portion faces toward the patient's neck, and therefore the inner surface of the collar is free of obstructing protrusions.

[0327] The connector portion may be, for example, a portion of a dome-style fastener of known type.

[0328] The distal end of the inner end 4102 may include an outwardly projecting loop that engages the overlapping portion of the collar strap. This loop 4302, shown only in FIG. 43, aligns the free end of the underlying overlapping end 4102 with the overlapping portion of the collar when the collar is sized tight.

[0329] Figures 46-49 show alternative connectors for adjustable connections. Figure 46 shows the dome fastener connection in detail.

[0330] 47 shows an alternative fastener using mating magnets. The outer strap end 4702 includes an inward-facing magnet portion 4704. The inner strap end 4706 includes an outward-facing magnet portion 4708. The inward-facing magnet portion 4704 is preferably magnetized with a first magnetic field that faces inward. The outward-facing magnet portion 4708 is preferably magnetized with a complementary magnetic field that faces outward. A series of outward-facing magnets 4708 are spaced along the outer surface of the inner strap portion 4706.

[0331] The magnet portion may be secured to the base portion 4710, which in turn may be secured to the strap. For example, the magnet may be adhesively attached to a substrate material that can be sewn to the strap. Alternatively, the magnet may be molded to include a hole that allows the magnet to be sewn directly to the strap.

[0332] Magnet 4704 can be replaced with a magnetic material that is attracted by magnet 4708 rather than the magnet itself. Alternatively, magnet 4708 can be replaced with a piece of material that is magnetic but not itself a magnet. As an example, the magnet can be ferrite or rare earth, while the magnetic material can be small pieces of steel. Ferrite powder bonded to a plastic polymer can make the magnet plastic while still maintaining sufficient strength to secure the collar.

[0333] 48 shows an adjustable connection made by a hook-and-loop fastener system. For example, an outer end portion 4802 may include a short section of material 4804 with protruding hooks. An inner strap end 4806 may include an outwardly facing portion 4808 covered with a loop through which the hooks may engage and disengage. A suitable hook-and-loop fastener material is sold under the Velcro® brand.

[0334] The outwardly facing loop material may be sewn to the collar strap, or the collar strap may be formed from a material that integrally includes the loop. The length of the loop portion 4808 is much longer than the length of the hook portion 4804, and preferably extends a length equivalent to the adjustment desired to be available in the collar. For example, the loop fastener material may have a length of approximately 15 cm along the collar strap.

[0335] Figure 49 shows an alternative mechanical fastener that is similar to a dome fastener. This type of dome fastener includes a small receiving aperture 4902 in the female portion and a small protruding pin 4904 in the male portion.

[0336] 43-45, the collar preferably includes a second releasable connection 329 between the third end 4302 and the fourth end 4304. The overall collar ring is therefore divided into two separate strap sections, each including an adjustable connection 327 at one end portion and a second connection 329 at the other end portion.

[0337] Preferably, this second connection is non-adjustable. This second connection 329 is intended to engage and disengage with each use of the collar. An adjustable connection can be adjusted to reset the length, and the second connection 329 can be used to secure and release the collar.

[0338] This second connection 329 may be formed by any suitable means, including the examples shown in Figures 46-49, or including a conventional removable fastening clip as shown in Figures 50A and 50B (Figure 50A connected and Figure 50B released), or by a breakaway connector that releases when a predetermined range of tension is applied.

[0339] The connection 329 shown in FIG. 45 includes a breakaway connector having a first body portion 4502 secured to the strap end 4302 and a second body portion 4504 secured to the fourth strap end 4304. The first and second body portions each include a protruding tang and a receptacle. The protruding tang of one body is complementary to the receptacle of the other body. The protruding tang and the receptacle preferably have an interference fit. The amount of interference and the force required to unscrew the tang from the receptacle define the release force of the breakaway clip.

[0340] This preferred breakaway clip is shown in detail in Figures 51A and 51B. In Figure 51A, the clip is shown in an open configuration with a tang 5102 protruding from each clip body portion, each tang 5102 including a small lateral protrusion 5104. The receptacle in each body portion of the clip includes a lateral aperture 5106. When the tang 5102 is pressed into the receptacle, the protrusion 5104 extends into the aperture 5106. The engagement of the protrusion 5104 in the aperture 5106 creates an interference fit. Figure 51B shows the connector in its engaged state.

[0341] Referring again to Figures 41-45, a tether extends from the collar. The tether 4112 connects to the collar at one end and engages a clip 4114 at its free end. The engagement clip 4114 is for connecting with a supply conduit for the patient interface. Figure 55 shows the engagement clip 4114 in detail and provides a close-up view of its attachment to the cuff of the conduit. A preferred connector includes an open loop that fits over the sleeve portion of the cuff and is held in place between a flange 5502 on the cuff and a flange 5504 on the swivel conduit that is connected to the cuff.

[0342] A preferred tether includes breakaway clips at several locations along its length between the connection to the collar and the conduit connector. The breakaway connector may be of the form already described with reference to Figures 51A and 51B. That form of breakaway connector is shown in Figures 52, 54A and 54B.

[0343] Alternatively, the separation connector may also include a swivel to eliminate the need to correctly orient the collar relative to the conduit before attaching the patient interface. In this case, the separation connector includes a receptacle portion 5302 and a male portion 5304, where the male portion 5304 may be rotationally symmetric. For example, the male portion 5304 may include a protruding knob 5306 having an enlarged end 5308. The receptacle 5302 may include a protruding portion or annular protruding portion on its inner circumference adjacent the open end. The receptacle 5302 may need to be made in two pieces that are later fastened together to create the protruding lip or lips. The receptacle portion 5302 may be open at its other end 5310, allowing the connector portion 5302 to be formed in one piece. This end may accommodate the end of the strap portion 5312 of the tether.

[0344] Alternatively, the swivel may be included at another location along the tether.

[0345] Preferably, the tether is formed with a sliding connector 5202 at one end for connecting to the collar. The sliding connector 5202 preferably comprises a shaped loop that includes straight portions on either side of the web of the collar and is joined by transverse portions above and below the edge of the collar. The loop preferably fits the collar reasonably snugly so that once moved into position, it tends to stay in place, but can move along with the collar if sufficient force is applied. The loop 5202 substantially mirrors the contours of the web of the collar. The tether extends from the loop 5202 and is preferably integrally formed therewith. Preferably, the tether and loop are formed from a flexible, elastic material such as silicone.

[0346] Another tether extends from the quick release connector to the conduit of the mating clip, and again this may be formed from any suitable material, preferably a flexible, preferably silicone material.

[0347] The tether can be of fixed or adjustable length. Preferably, the tether is available in multiple lengths for patient selection. The tether can be 3 cm to 15 cm long. A tether of approximately 3 cm is shown in Figures 54A-54B, including the limited strap portion, if any. This tether is mostly made by its loop connector to the collar, by the quick release connector, and by its connection to the conduit connector.

[0348] 52 and 53 show a long tether that includes a substantial strap portion between the connection loop 5202 and the quick release connector, and another substantial strap portion between the quick release connector and the conduit connector. These portions of the tether can be interchanged, so that, for example, the strap portion of the tether can all be on one side or the other of the breakaway connector.

[0349] 56 shows an alternative support configuration for use with a collar. Instead of terminating in a connector for the collar, the tether 5602 terminates in a clip 5604. The clip 5604, preferably in the form of a clothes peg, alligator clip, or other type of configuration with gripping jaws, is for attachment to the neckline or other convenient portion of clothing worn by the patient. Alternatively, the tether may terminate in a connector for connection to a prosthetic structure for wear by the patient, as previously described.

[0350] The tether may or may not include a breakaway connector.

[0351] 57 shows another alternative for connecting to a patient's garment 5702. It shows a push clip 5704 that connects to the color line of the garment and includes a breakaway connector 5706.

[0352] A preferred collar is constructed from a material that is comfortable to the wearer. In its simplest form, the collar may be, for example, a strap of soft, flexible material that is stiff enough to maintain the overall collar shape, strong enough to withstand any significant stretching or pulling, and comfortable on the inner surface facing the patient. One suitable material may be, for example, a laminated foam material such as Breatoprene, which has a foam web with a knitted surface on either side.

[0353] However, preferred collars are more tensile-resistant and breathable than Breathoprene materials. To be comfortable against the skin, the collars are preferably fabric-faced with woven, knitted, or braided natural fibers. For example, they may be braided or knitted tubes made of cotton or bamboo thread. To give the collar shape, the braided or knitted tube surrounds a flexible framework. The flexible framework may include a series of hinged frames or molded flexible straps formed with an open framework. Preferably, it includes thin straps of plastic mesh. An example of a suitable mesh is 3MESH, manufactured by the Mullter Texti Group in Germany. The open framework or mesh configuration allows moisture and heat to easily pass through the collar, reducing discomfort for patients wearing the collar for extended periods.

[0354] The collar strap is preferably 3cm to 6cm wide and 3mm to 8mm thick.

[0355] Figures 1-3 show one preferred simple head strap. It comprises a single, non-forked strap terminating in connectors at both ends. The strap can be permanently connected to both ends of the frame, but preferably the connectors are configured to be removable from the body of the mask. Figures 10A-10C show another preferred head strap, and Figures 63A-63D show a preferred connecting clip.

[0356] A single, non-forked strap preferably accommodates considerable variations in head size without the need for adjustment. The stiffness of the preferred strap is very soft; a fully extended, unstretched 400 mm king strap requires a force of 4 N or less, preferably 2 N or less, to stretch to 1.3 times its original length. Figure 62 is a graph showing the force versus extension characteristics of four sample strap materials. Preferred materials include knitted or braided tubular nylon yarns incorporating Lycra® twist. The nylon yarns are formed loosely enough to allow stretch beyond the necessary range without becoming too tight. The amount of Lycra® twist in the yarn can be varied to change the stiffness of the strap. The overall diameter or width of the strap is preferably less than 10 mm, most preferably less than 6 mm.

[0357] The strap end connectors may be attached to the strap in any suitable manner. Preferably, the end connectors are overmolded onto the ends of the strap. Figure 62 shows test results for a range of alternative strap materials. All test results are for a length extension of the tested material with a "rest" length of approximately 400 mm.

[0358] Line 6202 shows the elongation test results for a nylon braided yarn incorporating Lycra filaments, with the braided tube having a nominal diameter of 5 mm. This is also stiffer than desired.

[0359] Line 6206 represents the hypothetical most favorable response as determined by the inventors.

[0360] Line 6209 shows the response of a stretched silicone hollow tube with a wall thickness of 0.25 mm and an outer diameter of 3 mm.

[0361] Line 6207 shows the response of a stretched silicone hollow tube with a wall thickness of 0.25 mm and an outer diameter of 6 mm.

[0362] Both of these silicone extensions exhibit satisfactory properties.

[0363] Line 6205 shows the response of a preferred nylon braided yarn incorporating Lycra filaments. The braided tube had a nominal diameter of 4 mm.

[0364] Line 6208 shows the response of a 3 mm length of woven elastic webbing. This product exhibited similar properties to the preferred knit yarn, however the elastic webbing exhibits a tendency to catch hair and lose elasticity.

[0365] Head strap The most preferred head strap comprises a braided elastic band. Lengths of elastic thread are wound onto spools. The spools of thread are then used in a braiding machine to create a continuous braided tube. The tube is passed over or between one or more rollers to flatten the tube into a band.

[0366] The preferred cross-sectional dimensions of the head strap are approximately 6 mm wide and 1.5 mm thick.

[0367] According to the most preferred embodiment, the thread is a twisted Lycra (elastane or spandex) yarn with a spun wrapper. The twisted elastane yarn may be, for example, a 900 denier twisted Lycra (elastane or spandex).

[0368] The spun wrapper may include at least one yarn of nylon filaments. The wrapper may include a primary wrapper yarn and a secondary wrapper yarn. Each yarn may include a spun yarn including a plurality of nylon filaments.

[0369] For example, each wrapper may include a thread of nylon filament.

[0370] The nylon filament contributes to the color of the elastic thread. For example, for a white head strap, the nylon wrapper should contain white nylon filament.

[0371] When preparing a spool of elastic thread, preferably multiple threads of elastic thread (preferably three threads) are wound in parallel onto the spool so that during the braiding process each element actually comprises a bundle of three parallel threads.

[0372] Preferably, the braiding is performed on a 16-spool braiding machine, such as a Ratera 16 / 80 braiding machine available from Talleres Ratera SA of Barcelona, ​​Spain. Each spool of thread for braiding is prepared with three parallel threads as described above.

[0373] The braider is configured to produce a suitable braid (e.g., by setting tension, speed, or both). Example speed control settings for a Ratera 16 braider are A: 45, B: 20, C: 30, and D: 35.

[0374] Head straps made according to this description were tested by incremental extension and the force at each extension was recorded. The force versus extension results for a 300 mm length of prototype strap material are shown in Figure 64.

[0375] Figures 63A-63C illustrate preferred headgear strap features. In particular, Figures 63A-63C illustrate preferred configurations for attaching connectors to the ends of a preferred elastic strap material. Figures 63A-63C also illustrate preferred connectors for connecting the straps to the frame of the interface.

[0376] Figures 63D-63I show another similar headgear strap that shares many of the features of the headgear strap of Figures 63A-63C, and in the following description will share both the embodiment and reference numbers unless otherwise noted.

[0377] At least one end of the strap 6304, and preferably both ends, terminates in a connector 6302. Once assembly of the interface is complete, the connector 6302 engages with the side portion 1016 of the frame.

[0378] To form the connector, the flattened tube 6306 is encapsulated in the plastic body 6308 or 6350, for example by overmolding.

[0379] In the embodiment of Figures 63D-63J, the band is encapsulated by a relatively soft material, such as a thermoplastic elastomer.

[0380] The plastic body 6308 may have gripping features, such as bumps or ridges 6324, or recesses 6352 on its outer surface.

[0381] The body 6308 terminates at its other end in an end surface that is preferably sized and shaped to fit over the end surface of the side portion 1016. The connectors and receptacles are preferably shaped to provide a rigid connection between the connectors and the frame such that, when engaged, the connectors become rigid extensions of the side portion of the frame. Accordingly, each connector contributes to their length to the frame and defines the point where the flexible straps leave the frame.

[0382] A preferred connection includes a metal plug portion extending from the end face of the connector 6302 and engaging a receptacle 1062 formed in the end face of the frame. A metal (preferably steel or titanium or similar material) plug portion is stiff and strong yet retains a compact form factor.

[0383] The plug portion may advantageously be formed from a metal wire 6310. For example, the plug portion may be formed from a length of stainless steel wire.

[0384] The wire can be bent back on itself and both ends are wrapped in the connector 6302 so that the wire forms a loop that protrudes from the end face of the connector. To cooperate with this loop, the receptacle can be in the form of a slot, the overall shape of which can match the essentially flat pin formed by the loop.

[0385] The loop may include a rim 6316 that includes a protruding bend or ridge. The protruding bend 6322 is adapted to engage a shallow notch 6344 in the receptacle 1062. The notch 6344 may be formed along one edge surface of the slot.

[0386] The loop may have a protruding end portion 6318 at the portion furthest from the connector 6302. The slot may have an edge surface that closely matches at least the cross-sectional profile of the end portion 6318 to closely receive the end portion when the loop is engaged in the slot, thereby securing the connector against rotation in the plane of the loop.

[0387] The thickness of the slot preferably closely matches the thickness of the wire, thereby securing the connector against rotation perpendicular to the plane of the loop.

[0388] The loop has a straight rim 6320 and the slot can have complementary straight edge surfaces that provide a sliding reference surface for aligning the connector with the receptacle during and after engagement.

[0389] If one limb of the wire loop is bent and the other limb is straight, and the slot is provided with a complementary surface, the connector can be formed with a shape that ensures correct orientation of the connector relative to the receptacle. For example, the connector can have a shape that is clearly a continuation of the shape of the frame.

[0390] If a connector and receptacle are provided at both ends of the strap, the connectors (and receptacles) may have opposite orientations, for example, one receptacle may have a recess 6334 on its lower edge surface and the other receptacle may have a recess on its upper edge surface.

[0391] Alternatively, the connector may have features or indicia that ensure correct selection of the target receptacle and correct orientation relative to the selected receptacle.

[0392] 63A and 63C, one of the main limbs of the wire loop may be free to move within the cavity 6314 of the connector body 6308. Preferably, the free end 6340 is the end of the limb 6316 having the protruding bend. With less freedom of movement within the cavity 6314, the wire loop flexes more than if the end were constrained. This flexing reduces the peak force required (and generated at the receptacle) during connection and disconnection of the connector.

[0393] The cavity 6314 includes a slot opening into the connector body 6308 from the end face of the connector body.

[0394] The other end of the wire loop can be formed with a portion that is inserted into the material of the connector body. For example, a portion of the wire can be bent into a curve and overmolded with the plastic material of the connector body. This portion can overlap the encapsulated end of the strap 6304 inside the connector body.

[0395] To form this connector, the wire loop and strap are assembled with a sleeve, and the assembly is overmolded. For example, the sleeve (which may be plastic) may have a blind cavity to accommodate the end 6340 of the wire loop and an open-end cavity to accommodate the other end of the wire loop (which passes through one end of the cavity) and the end of the strap (which passes through the other end of the cavity). The sleeve may then be overmolded, or at least the open-end cavity that holds the fixed ends of the strap and loop may be filled. Alternatively, the sleeve may be formed in two halves that are clipped together over the wire loop. The two halves may be joined, for example, by a hinge. The halves may also clip over the end of the band 6306 and roughly grip the end of the band before overmolding. For example, the gripping protrusions 6360 may engage the end 6362 of the band.

[0396] According to the embodiment of Figures 63D-63J, a soft cover material 6350 is provided along the length of the highly flexible pliable band 6306 and over the sleeve by overmolding the connector with a soft material, such as a thermoplastic elastomer. This culminates in a flexible section 6370 that is the transition between the rigid section 6372 of the connector and the highly flexible strap. Preferably, this flexible section is progressively more flexible as it extends away from the rigid section 6372. For example, the overmolded cover section may be tapered as it extends away from the sleeve, or the cover may be provided with indentations (e.g., indentations 6352), or both.

[0397] In masks where the headgear straps connect to rigid protruding parts (e.g., in some embodiments of the masks described herein), the protruding soft parts of the connectors provide a soft cushion against impacts from the protruding hard parts or pins.

[0398] Preferably the flexible portion extends 5mm to 60mm along the band or strap, most preferably 10mm to 20mm. The flexible material may be selected from a wide range of flexible plastics, allowing for bonding of the strap material to the sleeve material.

[0399] In this connector, one of the edge surfaces of the receptacle 1062 may include a first portion 6332 that fits over the end portion 6318 of the loop, a recess or notch 6334 that fits over the protruding bend 6322, a raised portion 6366 that secures the bend 6322 in the notch 6334, and a recessed lead-in area 6338 that allows the loop to fully enter the slot before requiring maximum connection force to push the bend 6322 over the raised portion 6366.

[0400] The described connector is compact, acts as an extension of the interface frame, and has a simple and intuitive method of connection and disconnection.

[0401] FIGS. 58-61 illustrate another patient interface incorporating a seal substantially as described above and, similar to FIGS. 10-12, including features that may eliminate or reduce the need for additional support for the conduit. According to this embodiment, the mask body includes depending stabilizers 6102. A depending stabilizer is provided on each side of the mask body. Each depending stabilizer extends beyond the periphery of the mask seal and includes a foot 6104 to engage the wearer's upper lip. Preferably, the stabilizers do not extend beyond the inner surface of the seal but are spaced forward from the inner surface of the seal and positioned such that the depending stabilizer foot 6104 does not contact the wearer when the mask is symmetrically fitted to the patient in use. Each foot 6104 may include a pad 6106 of soft material, such as a soft polymer or elastomeric foam, or a hollow silicone extrusion. The stabilizer may be integral with the seal rather than the frame, for example, formed integrally as a molded silicone body extending from adjacent the central opening and projecting beyond the lower edge of the seal, in which case features on the mask body can fix the position of the inboard ends of the stabilizer.

[0402] Each stabilizer extends downward to the lower region of the seal and is adapted to engage the area of ​​the patient's upper lip in the region bounded by the mouth, nose, and nasolabial folds, preferably without engaging the patient's cheeks. Accordingly, the feet are profiled and positioned to conform to this area. Each stabilizer 612 and arm 6108 extends from a lateral central portion 6110 of the mask body. The configuration of the arms and the material of the arms can be rigid or allow the arms to have a desired flexibility. Generally, the arms should be rigid.

[0403] The purpose of the stabilizers is to ensure that the interface sits flush against the user's upper lip area when correctly positioned, and to contact the user's upper lip area when the interface is rocked to one side or the other against the user's nose, for example under the influence of a supply conduit. Light pressure on the stabilizer feet 6104, which are spaced laterally from the mask centerline, preferably towards the distal edges of the mask, supports the mask against these lateral forces from the conduits and stops the mask from rocking too far across the face and breaking the seal.

[0404] Additionally, the stabilizers hang down the underside of the mask to support it if the weight of the conduits tends to cause the mask to roll forward, in which case both stabilizer legs 6104 will contact the user's upper lip and support the mask in place.

[0405] The stabilizers are shown in a preferred form as having a substantially rigid configuration, but with flexible or soft padding 6106. However, due to variations in patient geometry, these stabilizers can be selectable attachments, and the connection configuration to the mask allows for different configurations of stabilizers to be substituted. Alternatively, the stabilizers can be made adjustable, such as by providing hinged portions that allow for multiple fixation positions along the length of the stabilizer, or at the joints and / or feet of the arms. Alternatively, the arms can be formed from a malleable material that can be significantly affected, allowing the arms to bend into a desired position and remain in that position due to the effect of the material.

[0406] In embodiments involving hinged arms or feet, a linkage arrangement can be provided to couple the movement of each of the stabilizers, or the stabilizers can be individually or collectively supported in position by one or more springs or other resilient members.

[0407] By adding stabilizers, the mask can be placed sufficiently securely on the patient without the need for additional support for the conduits. Similarly, this can allow the length of the flexible connecting tube 6120 to be shortened. Thus, the flexible connecting tube 6210 (which is generally much more flexible than the main supply conduit) can be reduced in length to between 5 cm and 15 cm, preferably about 10 cm. In systems including a humidified gas supply and a heated main supply conduit, this short flexible connecting tube is typically not heated. If the connecting tube needs to be supported by a lanyard or collar, the minimum length is typically greater than 15 cm. If the requirement for a collar lanyard is eliminated, the short connecting tube is provided solely for flexibility, separating the relatively rigid supply conduit from the mask and allowing the wearer to move their head freely. Because the connecting tube is typically not heated, humidity from the gas carried by the tube can rain out onto cold wall surfaces, eventually forming pools of water that can be blown into the user's nostrils and cause discomfort. Providing a short tube, as made possible by the lip stabilizer, reduces potential rainout in the conduit.

[0408] Interface configurations incorporating a single flexible head strap, nose seal, and a low-profile frame that can be stabilized on the upper lip, all in a one-size-fits-all package (preferably both the headstap and seal), can be improved if the short connecting tube is particularly flexible. Flexible tubing means that the tube bends easily when force is applied. For example, a suitable tube may meet the test criteria described below with reference to FIG. 65.

[0409] According to the Figure 65 test, a 150 mm length of tubing is clamped at each end to a cylindrical support that extends into the bore of the tubing at each end. This leaves approximately 130 mm of tubing hanging freely or bridging between the support ends. This bridging must be in a relaxed state, neither retracted nor extended. A 5 N lateral force at the center of the tube results in a deflection of more than 13 mm.

Claims

1. a nose seal including a face-contacting side, the nose seal being formed of a soft, flexible material and including a central portion extending across the base of the nose and side portions extending from each end of the central portion, each side portion extending across a side of the nose; a face-contacting side of the seal that is flexible and conforms under internal pressure to the surface of the wearer's nose, including the outer surface of the side of the nose at the side portions of the seal; an outer side including a region that is much stiffer than the flexible inner side and that extends to the side portion of the seal; a patient interface including:

2. The patient interface of claim 1 , wherein the side portions of the seal are substantially parallel to one another and substantially perpendicular to the central portion of the seal.

3. 3. A patient interface according to claim 1 or 2, wherein the outer walls of the side portions of the seal are aligned to have an angle between their orientations of 0 to 30 degrees.

4. 4. A patient interface according to any one of claims 1 to 3, wherein the seal includes a pair of nasal locators on the face-contacting side thereof, and wherein an area of ​​the seal on the face-contacting side thereof immediately adjacent to and including the nasal locators is stiffer than an area surrounding this area.

5. 5. A patient interface according to any one of claims 1 to 4, wherein a peripheral portion of the seal where the face-contacting side joins the outer side is flexible to allow the inner side of the seal to displace relative to the outer side.

6. A patient interface according to any preceding claim, wherein the exterior side of the central portion of the seal includes an aperture to allow gas to pass to the interior of the seal.

7. A patient interface according to any preceding claim, wherein the flexible portion of the seal comprises a silicone material having a thickness of between 0.05mm and 0.5mm.

8. A patient interface according to any preceding claim, wherein the flexible portion of the seal comprises an elastomer having a thickness of between 0.1 mm and 0.2 mm.

9. A patient interface according to any preceding claim, wherein the rigid portion of the seal comprises a silicone material having a thickness of between 2mm and 5mm.

10. A patient interface according to any preceding claim, wherein the rigid portion of the seal comprises an elastomer having a thickness of 2mm to 3mm.

11. A patient interface according to any preceding claim, wherein the area immediately adjacent and including the nasal locators comprises a silicone material that is between 0.5mm and 2mm thick.

12. A patient interface according to any preceding claim, wherein the overall width of the seal from the outer surface of one side portion to the outer surface of the other side portion is between 30mm and 60mm.

13. A patient interface according to any preceding claim, wherein the total depth of the seal from the outer surface of the central portion to the line where each side portion joins an end is between 40mm and 65mm.

14. 14. A patient interface according to any preceding claim, comprising a body assembled to the nasal seal, the body being formed from a more rigid material than the nasal seal and forming together with the nasal seal an enclosure having an inlet opening and a patient outlet opening, the inlet opening having a swivel elbow connected to it.

15. 15. A patient interface according to claim 14, wherein the connection of the swivel elbow to the body provides for rotation of the swivel elbow relative to the body and pivoting of the swivel elbow relative to the body about at least a lateral axis.

16. 16. A patient interface according to claim 15, wherein the connection comprises a ball-and-socket joint.

17. 17. A patient interface according to any one of claims 14 to 16, wherein the elbow comprises a first end, a second end, and a flow channel between the first and second ends, the flow channel being aligned in a first direction at the first end and a second direction at the second end, the first direction and the second direction forming an angle of between 120° and 180°.

18. 18. A patient interface according to claim 17, wherein the angle is between 120° and 150°.

19. 18. A patient interface according to claim 17, wherein the angle is between 130° and 140°.

20. A patient interface according to any one of claims 14 to 19, wherein the elbow includes a gas relief vent.

21. 21. A patient interface according to claim 20, wherein the gas relief vent is aligned with a gas flow path from the nose seal and body assembly to the elbow.

22. 22. A patient interface according to claim 30 or 21, wherein the gas relief vent comprises a plurality of holes through a wall of the elbow.

23. 23. A patient interface according to any one of claims 1 to 22, comprising a body assembled to the seal and a looped strap extending from the assembled body and nasal seal, the strap exiting at one end from a first portion of the assembled body and nasal seal and at the other end from a second portion of the assembled body and nasal seal.

24. 24. A patient interface according to claim 23, wherein the strap includes a single, non-divided band along the length of the strap that engages the wearer's head.

25. 25. A patient interface according to claim 23 or 24, wherein the strap engages the body at both ends.

26. 26. A patient interface according to claim 25, wherein the body is formed from a rigid material, the strap is relatively flexible with respect to the body and includes a soft portion, the portion of the strap that engages the body is formed from a material that is more flexible than the material of the body and less flexible than the material of the strap, the soft portion forming a soft extension of the body when engaging the body.

27. 27. A patient interface according to claim 26, wherein the soft portion extends between 5 mm and 60 mm along the strap.

28. 26. A patient interface according to claim 25, wherein the strap engages the body at both ends with detachable connectors.

29. 29. A patient interface according to claim 28, wherein the strap includes a soft cover portion extending from the detachable connector a distance along the strap of between 5 mm and 60 mm, the soft cover portion being formed of a softer material than the body.

30. A patient interface according to any one of claims 23 to 29, wherein the band is narrow, preferably less than 10mm wide.

31. A patient interface according to any one of claims 23 to 28, wherein the band has a width of less than 6mm.

32. A patient interface according to any one of claims 23 to 31, wherein the band has a stiffness of less than 2N per 100mm of extension from a relaxed state.

33. A patient interface according to any one of claims 23 to 32, wherein the band is formed from a knitted or braided yarn incorporating filaments of a highly elastic material and filaments of a much stiffer material.

34. 34. A patient interface according to any one of claims 23 to 33, wherein the strap includes soft end portions that are stiffer than the strap between the end portions but softer than the body, the soft end portions also acting as soft extensions of the body.

35. 35. A patient interface according to any preceding claim, comprising a tube depending from the seal and body, and a tube support connected to the tube and connectable to the patient's neck or clothing.

36. 36. A patient interface according to claim 35, wherein the tube support comprises a collar fastenable around the neck of the wearer.

37. 37. A patient interface according to claim 36, wherein the collar has first and second end portions, the first and second end portions including fastening arrangements allowing the end portions to be fastened with a selectable amount of overlap.

38. 38. A patient interface according to claim 37, wherein the collar includes a third end portion, a fourth end portion, and a connector connecting the third end portion to the fourth end portion.

39. 39. A patient interface according to claim 38, wherein the connector is configured to release the third end portion from the fourth end portion upon application of a tension on the connector that is greater than a release tension, the release tension being less than 10 Newtons.

40. A patient interface according to any one of claims 35 to 39, wherein the collar has a width of between 30mm and 60mm.

41. A patient interface according to any one of claims 31 to 36, wherein the collar has a core material and a cover material surrounding the core material.

42. 42. A patient interface according to claim 41, wherein the core material is a dimensionally stable, breathable mesh.

43. 43. A patient interface according to claim 41 or 42, wherein the cover material is a braided or knitted natural fiber.

44. A patient interface according to any one of claims 35 to 40, wherein the tube support includes a tether extending from the collar and having a connector fixed or fixable to the tube at one end.

45. 45. A patient interface according to claim 44, wherein the tether includes a connector at the outer end, the collar passing through the second connector.

46. 46. ​​A patient interface according to claim 44 or 45, wherein the tether comprises a first end, a second end, and a connector connecting the first end and the second end, the connector configured to release upon application of a tension greater than a release tension, wherein the release tension is less than 10 N.

47. 47. A patient interface according to claim 46, wherein the connector of the strap includes a first portion and a second portion, and wherein in an engaged state the first portion pivots relative to the second portion.

48. A patient interface according to any one of claims 44 to 47, wherein the connector that engages the tube comprises a ring.

49. 49. A patient interface according to any one of claims 1 to 48, comprising a body connected to the seal and including a nasal seal engagement portion that engages an exterior side of the seal, an entrance opening, and at least one strap engagement portion from which extends a loop strap for securing the interface to the patient.

50. 50. A patient interface according to claim 49, wherein the loop strap includes a soft intermediate portion extending from the strap engaging portion, the soft intermediate portion being formed from a material that is stiffer than the strap but softer than the material of the body.

51. 51. A patient interface according to claim 49 or 50, wherein the body includes two strap-engaging portions, each strap-engaging portion extending laterally away from the entrance opening from opposite sides of the entrance opening.

52. 47. The patient interface of claim 46, wherein each strap engaging portion extends away from the entrance opening in a region where the strap engaging portion overlaps the outer wall of the seal.

53. 53. A patient interface according to any one of claims 49 to 52, wherein a central portion of the body defines a convex shape that generally matches the convex shape of the outer wall of the body, with strap engaging portions extending from lateral ends of the central portion, the strap engaging portions extending away from the central portion at an angle aligned outwardly relative to the generally convex shape.

54. 54. A patient interface according to any one of claims 49 to 53, wherein the strap engaging portion extends away from the outer wall of the seal at a thread angle of greater than 30 degrees.

55. 55. A patient interface according to any one of claims 49 to 54, wherein the strap engaging portion has a length from the point where it diverges from the outer wall of the seal that is between 50% and 150% of a corresponding length of the outer wall of the seal.

56. 56. A patient interface according to any one of the preceding claims, including a body engaged with the nasal seal, the body being more rigid than the nasal seal, with a lip support depending from the body and extending beyond the seal edge.

57. 57. A patient interface according to claim 56, wherein the lip support includes one or more pads for engaging an upper lip portion of the wearer.

58. 58. A patient interface according to claim 56 or 57, wherein the lip support includes two depending legs spaced apart at opposite lateral regions of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

59. A patient interface according to any one of claims 56 to 58, wherein each leg carries a padded portion facing towards the upper lip.

60. 60. A patient interface according to claim 58 or 59, wherein the legs are shaped to be less stiff about an axis parallel to the portion of the wearer's lips that they contact than about an axis perpendicular to the plane of the lips.

61. 1. Headgear for a patient interface, comprising: An elastic band having a width of 3 mm to 6 mm; A hardness that provides an elongation of 150 mm with a force of less than 2 N; a first end connected or connectable to a first lateral portion of the mask, and a second end connected or connectable to a second lateral portion of the mask; Including headgear.

62. 62. Headgear for a patient interface according to claim 61, wherein the band has a length at its relaxed length of between 300mm and 400mm.

63. 63. Headgear for a patient interface according to claim 62, wherein the band lengthens by 60mm to 110mm when subjected to an extension force of 1N.

64. 64. Headgear for a patient interface according to any one of claims 61 to 63, wherein the band is constructed from a knitted or braided yarn, the yarn comprising filaments of a first material and filaments of a second material that is more elastic but much softer than the first material.

65. 65. Headgear according to any one of claims 61 to 64, wherein the bands comprise braided yarns, and the yarns comprise elastane filaments with a spun wrapper.

66. 66. Headgear according to any one of claims 61 to 65, wherein the band comprises a plurality of braided thread bundles, each thread bundle comprising at least two threads, and each thread comprising an elastane core and a spun wrapper.

67. 67. Headgear according to any one of claims 61 to 66, wherein the first strap end, the second strap end, or both, include soft cover portions extending 5mm to 60mm along the straps, the soft cover portions being stiffer than the straps.

68. 68. Headgear according to claim 67, wherein the cover portion is of a softer material than the lateral portions of the mask to which it is connected.

69. 69. Headgear for a patient interface according to any one of claims 61 to 68, wherein the headgear includes a first connector at the first end and a second connector at the second end.

70. 70. Headgear according to claim 69, wherein the connector includes a resiliently deformable spring clip engaged with a clip body.

71. 71. The headgear of claim 70, wherein the connector includes a cover that surrounds and at least substantially encloses the clip body and a portion of the band, the cover being formed of a material that is stiffer than the band and softer than the material of the clip body.

72. 72. A patient interface comprising a strap according to any one of claims 61 to 71.

73. a nose seal including a face-contacting side, the nose seal being formed of a soft, flexible material; a body assembled to the nasal seal, the body being formed of a stiffer material than the nasal seal and forming with the nasal seal an enclosure having an inlet opening and a patient outlet opening; a lip support depending from the body and extending beyond the edge of the seal; a patient interface including:

74. 74. A patient interface according to claim 73, wherein the lip support includes one or more pads for engaging an upper lip portion of the wearer.

75. 75. A patient interface according to claim 73 or 74, wherein the lip support includes two depending legs spaced apart at opposite lateral regions of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

76. 76. A patient interface according to any one of claims 73 to 75, wherein each leg carries a padded portion facing towards the upper lip.

77. 77. A patient interface according to claim 73 or 76, wherein the legs are shaped to be less stiff about an axis parallel to the portion of the wearer's lips that they contact than about an axis perpendicular to the plane of the lips.

78. 78. A patient interface according to any one of claims 73 to 77, comprising a gas delivery tube depending from the body and a looped strap extending from the assembled frame and nasal seal, the strap exiting a first portion of the assembled body and nasal seal at one end and a second portion of the assembled body and nasal seal at the other end.

79. mask, a tube depending from the mask; and a tube support including a collar connected to said tube and fastenable around the neck of a wearer; a patient interface including:

80. 80. A patient interface according to claim 79, wherein the collar has first and second end portions, the first and second end portions including fastening arrangements allowing the end portions to be fastened with a selectable amount of overlap.

81. 81. A patient interface according to claim 80, wherein the collar includes a third end portion, a fourth end portion, and a connector connecting the third end portion to the fourth end portion.

82. 82. A patient interface according to claim 81, wherein the connector is configured to release the third end portion from the fourth end portion upon application of a tension on the connector that is greater than a release tension, the release tension being less than 10 N.

83. 83. A patient interface according to any one of claims 79 to 82, wherein the collar has a width of between 30mm and 60mm.

84. 84. A patient interface according to any one of claims 79 to 83, wherein the collar comprises a core material and a cover material surrounding the core material.

85. 85. A patient interface according to claim 84, wherein the core material is a dimensionally stable, breathable mesh.

86. 86. A patient interface according to claim 84 or 85, wherein the cover material is a braided or knitted natural fiber.

87. A patient interface according to any one of claims 79 to 86, wherein the tube support includes a tether extending from the collar and having a connector fixed or fixable to the tube at one end.

88. 88. A patient interface according to claim 87, wherein the tether includes a connector at the outer end, the collar passing through the second connector.

89. 88. A patient interface according to claim 87, wherein the tether comprises a first end, a second end, and a connector connecting the first end and the second end, the connector configured to release upon application of a tension greater than a release tension, the release tension being less than 10 N.

90. 90. A patient interface according to claim 89, wherein the connector of the tether includes a first portion and a second portion, and wherein in the engaged state the first portion pivots relative to the second portion.

91. a nose seal including a face-contacting side, said nose seal being formed of a soft, flexible material and including a central portion extending across the base of the nose and side portions extending from each end of said central portion, each side portion extending across a side of the nose; a body connected to the seal, the body including a nose seal engaging portion that engages an outward-facing side of the seal, an entrance opening, and at least two strap engaging portions, each strap engaging portion extending laterally away from the entrance opening from opposite sides of the entrance opening; a strap extending between the strap engaging portions; 1. A patient interface comprising:

10. A patient interface, wherein a central portion of the body defines a convex shape that generally matches the convex shape of the outer wall of the body, and wherein strap engaging portions extend from lateral ends of the central portion, the strap engaging portions extending away from the central portion at an angle aligned outwardly relative to the generally convex shape.

92. 92. A patient interface according to claim 91, wherein the strap engaging portion extends away from the outer wall of the seal at a thread angle of greater than 30 degrees.

93. 92. A patient interface according to claim 91, wherein the strap engaging portion has a length from the point where it diverges from the outer wall of the seal that is between 50% and 150% of a corresponding length of the outer wall of the seal.

94. 94. A patient interface according to any one of claims 91 to 93, wherein the loop strap includes a soft intermediate portion extending from the strap engaging portion, the soft intermediate portion being formed from a material that is stiffer than the strap but softer than the material of the body.

95. Single loop head strap, a mask that covers at least the nostrils of the user; a supply conduit less than 200 mm in length coupled to said mask for free swivel movement, including substantial rotation about a plurality of orthogonal axes; 1. A patient interface comprising: A patient interface wherein the single loop head strap extends from the mask on both sides.

96. 96. A patient interface according to claim 95, wherein the supply tube is flexible such that the tube passes the test described herein with reference to FIG.

64.

97. a mask that covers at least the user's nostrils; a supply port on said mask for receiving a supply of gas; a bias flow vent on the mask that extends from the inside of the mask to the outside of the mask, the bias flow vent directing airflow in a direction less than 45 degrees relative to the frontal plane of an imaginary wearer's head and generally toward the forehead; a patient interface including:

98. 98. A patient interface according to claim 97, wherein the bias flow vent comprises at least one bias flow aperture in a wall of the mask, the portion of the wall comprising the bias flow aperture being aligned at greater than 45 degrees with respect to the wearer's coronal plane.

99. 99. A patient interface according to claim 98, wherein the wall portion having the bias flow holes is disposed within a front wall of the mask and forms a shelf relative to a surrounding portion of the front wall.

100. 100. A patient interface according to claim 98 or 99, wherein a plurality of bias diverting holes are distributed in a curvilinear pattern around the upper front surface of the interface.

101. 101. A patient interface according to any one of claims 97 to 100, wherein the mask has a general U-shape or V-shape that encases the user's nose, and wherein the bias flow vent is located at the base of the U or V.

102. 102. A patient interface according to claim 101, wherein the seal does not cover the bridge of the wearer's nose.

103. Frame and Seal 1. A patient interface comprising: the seal includes a patient-facing side having at least one patient-facing opening and a frame-facing side having at least one frame-facing opening; the seal engages the frame at a lip defined by the perimeter of the frame opening; 10. A patient interface, wherein the frame includes a first component and a second component, the first component including a first portion of a channel for engaging the lip of the seal, the second component including a second portion of the channel for engaging the lip of the seal, and the seal is engageable and disengageable from the channel by the first and second components connected to form the channel.

104. Frame and Seal 1. A patient interface comprising:

10. A patient interface comprising: a frame including a first component and a second component engaged with one another; the first component including a portion forming a receptacle with a surface that contacts a movable portion of a freely swivel connector; the second component including an outer cover with an opening at the receptacle in the first component; and the patient interface further including a connector, wherein an interface portion that protrudes beyond the cover to the receptacle in the first component is engaged with the receptacle in the first component for free swivel movement.

105. 105. A patient interface according to claim 104, wherein the first component is formed from a different material than the cover, and the cover and the connector are formed from the same material.

106. 1. A patient interface comprising: a seal including a pair of nasal locators extending from a flexible back portion, each nasal locator including a tip, the nasal locators tapering from the back portion to the tip; and an opening at the tip of the nasal locator, wherein the opening and the tip portion of the nasal locator have a cross-sectional shape that is oval or elliptical, with a ratio of major axis length to minor axis length greater than 1.

5.

107. 107. A patient interface according to claim 106, wherein the ratio of the major axis length to the minor axis length is between 1.5 and 3.

108. 108. A patient interface according to claim 106 or 107, wherein the tip portion of the nasal locator includes a lip adjacent the tip opening, the lip being thickened compared to an adjacent portion of the tubular portion.

109. 109. A patient interface according to any one of claims 106 to 108, wherein the nasal locator includes a domed portion adjacent the dorsal portion and a tubular portion extending from an apex of the domed portion.

110. 110. A patient interface according to claim 109, wherein the domed portion extends around at least 60% of the circumference of the nasal locator.

111. 110. A patient interface according to claim 109, wherein the domed portion extends completely around the nasal locator.

112. A patient interface according to any one of claims 109 to 111, wherein the tubular portion extends in a tapered manner from the domed portion to the tip portion.

113. 113. A patient interface according to any one of claims 109 to 112, wherein the cross section of the nasal locator in a plane parallel to the plane of the tip opening is oval or elliptical across the tubular portion and the top of the dome-shaped portion.

114. 114. A patient interface according to any one of claims 109 to 113, wherein the ratio of the length of the major axis of the oval cross-section to the length of the minor axis of the oval cross-section gradually decreases from the tip of the tubular portion to the base of the domed portion.

115. A patient interface according to any one of claims 106 to 114, wherein the flow projection axes of the two nasal locators meet at a point between 10mm and 40mm from the tips of the nasal locators.

116. 116. A patient interface according to any one of claims 106 to 115, wherein central axes of the nasal locators that protrude beyond the tips of the locators meet closest at a point 10 mm to 20 mm beyond the tips of the nasal locators.

117. 117. A patient interface according to any one of claims 106 to 116, wherein the oval shape of the tip opening of the nasal locator is aligned so that when the tip opening projects into the frontal plane of an imaginary wearer, the major axes meet at an angle of between 60 degrees and 120 degrees.

118. Frame and Seal 1. A patient interface comprising: the seal includes a patient-facing side having at least one patient-facing opening and a frame-facing side having at least one frame-facing opening; the seal engages the frame at a lip defined by the perimeter of the frame opening; 10. A patient interface wherein the frame includes a front portion in the area of ​​the swivel connection to a supply conduit, the front portion being inclined with respect to the coronal plane of the imaginary wearer of the interface so that the lower edge of the portion is closer to the coronal plane than the upper edge of the portion, and the connector redirects flow from an inlet to the connector to an outlet of the connector at an angle of between 30 and 70 degrees, the connector and the inclined outer surface portion of the mask frame together allowing free swivel movement of the conduit, the conduit assuming a position approximately parallel to the coronal plane of the imaginary wearer, and the connector remaining close to the face of the wearer.

119. 119. A patient interface according to claim 118, wherein the connector does not include a bias flow vent.

120. Frame and Seal 1. A patient interface comprising: the seal includes a patient-facing side having at least one patient-facing opening and a frame-facing side having at least one frame-facing opening; the seal engages the frame at a lip defined by the perimeter of the frame opening; the frame including a feed opening through a front wall of the frame, a ring portion extending from the front wall and defining a passageway protruding from the inner surface of the front wall of the frame, and a protruding wall passing around the inner open end of the ring portion and engaging the lip of the seal; A patient interface wherein the front wall and the ring portion of the frame, together with other portions of the frame, define a plenum chamber, and a bias flow vent through the wall of the plenum chamber and an open area between the ring portion and the channel structure provide a flow path between the interior of the seal and the plenum chamber.

121. 121. A patient interface according to claim 120, wherein the bias diverter hole is disposed through the wall of the frame in an upper portion of the plenum chamber.

122. 122. A patient interface according to claim 120 or 121, wherein the ring portion 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, the two components being secured together to define the plenum chamber.

123. 123. A patient interface according to claim 122, wherein the protruding wall includes a channel, the channel accommodating the lip of the seal.

124. 124. A patient interface according to claim 122 or 123, wherein the channel follows a closed curved path having an overall width greater than its height such that the plenum chamber is formed primarily on either side of the ring portion.

125. 125. A patient interface according to any one of claims 122 to 124, wherein the ring portion connects to an upper central portion and a lower central portion of the protruding wall, and the flow path from the seal to the plenum chamber passes through both sides of the ring portion.

126. 123. A patient interface according to claim 122, wherein the protruding wall is formed as part of the same component as the ring portion.

127. 127. A patient interface according to claim 122 or 126, wherein the bias flow vent is formed through the front wall of the second component.

128. 128. A patient interface according to any one of claims 120 to 127, wherein the first component includes a laterally protruding shielding portion, the inner surface of the shielding portion being attached to the outer surface of the outer wall of the seal to inhibit outward deflection of the seal.

129. 129. A patient interface according to any one of claims 120 to 128, wherein the second component includes downwardly and laterally depending stabilizers for stabilizing it on the upper lip region of the wearer.

130. 130. A patient interface according to claim 129, wherein the first frame component comprises a skeletal frame and a minimum portion of the stabilizer portion of the component comprises an overmolded soft material.

131. Soft elastic seal, Rigid frame, a headgear connected to the frame; a rigid protrusion at the connection of the headgear to the frame; The headgear is very flexible within 60 mm of the frame, and between this point and the protrusion there is a soft section that is stiffer than the flexible section of the headgear but made of a material softer than the rigid frame. a patient interface including:

132. 132. A patient interface according to claim 131, wherein the protrusions resemble pins and are long and thin.

133. 133. A patient interface according to claim 132, wherein the soft portion extends from the general path of the pin.

134. A patient interface according to any one of claims 130 to 133, wherein the protrusion comprises a combination of a portion of the mask frame and a clip portion of the headgear.

135. A patient interface according to any one of claims 130 to 134, wherein the soft portion is part of the headgear.

136. A patient interface according to any one of claims 130 to 135, wherein the headgear is a simple single loop strap.

137. A patient interface according to any one of claims 130 to 136, wherein the protrusion projects laterally beyond the width of the seal.

138. 1. A patient interface comprising: a seal including a pair of nasal locators extending from a flexible back portion, each nasal locator including a tip, the nasal locators tapering from the back portion to the tip; and an opening at the tip of the nasal locator, the nasal locator further including a dome-shaped portion adjacent the back portion and a tubular portion extending from the apex of the dome-shaped portion.

139. 139. A patient interface according to claim 138, wherein the domed portion extends around at least 60% of the circumference of the nasal locator.

140. 139. A patient interface according to claim 138, wherein the domed portion extends completely around the nasal locator.

141. A patient interface according to any one of claims 138 to 140, wherein the tubular portion extends tapered from the domed portion to the tip portion.

142. A patient interface described in any one of claims 138 to 141, wherein the cross section of the nasal locator in a plane parallel to the plane of the tip opening is oval or elliptical across the tubular portion and the top of the dome-shaped portion.

143. 143. A patient interface according to any one of claims 138 to 142, wherein the ratio of the length of the major axis of the oval cross-section to the length of the minor axis of the oval cross-section gradually decreases from the tip of the tubular portion to the base of the domed portion.

144. A patient interface according to any one of claims 138 to 143, wherein the flow projection axes of the two nasal locators meet at a point between 10 mm and 40 mm from the tips of the nasal locators.

145. 145. A patient interface according to any one of claims 138 to 144, wherein central axes of the nasal locators that protrude beyond the tips of the locators meet closest at a point 10 mm to 20 mm beyond the tips of the nasal locators.

146. 146. A patient interface according to any one of claims 138 to 145, wherein the cross-sectional shape of the tip opening and the tip portion of the nasal locator is an oval or elliptical shape having a ratio of major axis length to minor axis length of greater than 1.

5.

147. 147. A patient interface according to claim 146, wherein the ratio of the major axis length to the minor axis length is between 1.5 and 3.

148. 148. A patient interface as described in claim 146 or 147, wherein the tip portion of the nasal locator includes a lip adjacent the tip opening, the lip being thickened compared to an adjacent portion of the tubular portion.

149. 149. A patient interface according to any one of claims 146 to 148, wherein when the tip opening of the nasal locator projects into the frontal plane of an imaginary wearer, the oval shape of the tip opening is aligned so that its major axes meet at an angle of between 60 degrees and 120 degrees.

150. 149. A patient interface according to any one of claims 1 to 60.

151. A patient interface according to any one of claims 106 to 117 or claims 1 to 60.

152. 152. A patient interface combination according to any one of claims 1 to 151.

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