HK40033671B - Patient interface and aspects thereof - Google Patents

Description

Patient interface and its various aspects

This application is a divisional application of invention patent application No. 201610116121.1, filed on March 1, 2016, entitled "Patient Interface and Several Aspects thereof".

Technical Field

This invention relates to a patient interface for delivering respiratory gases to a patient, and several aspects of the patient interface.

Background Technology

This invention relates to a patient interface for delivering respiratory gases to a patient. The invention will be specifically described with reference to a patient interface for delivering PAP treatment to a patient, such as a patient suffering from obstructive sleep apnea (OSA). However, this patient interface can be used for other treatments. Furthermore, various aspects of this patient interface can be combined with various aspects of other patient interfaces for PAP treatment or for other treatments.

Ideal features for a patient interface used in PAP treatment include lightweight, comfort, intuitive use, good sealing, and stability and safety during use.

In this specification, references have been made to patent specifications, other external documents, or other sources of information, generally to provide background for discussing the features of the invention. Unless otherwise expressly stated, references to such external documents should not be construed as an admission that such documents or such sources of information in any jurisdiction are prior art or constitute part of common knowledge in the art.

Summary of the Invention

One object of the present invention is to provide a patient interface, or multiple aspects of a patient interface that will provide the public with at least one useful option.

On one hand, the present invention can be generally described as a patient interface comprising a nasal seal including a side surface that contacts the face, the nasal seal being formed of a soft, flexible material and including a central portion extending across the base of the nose and a side portion extending from each end of the central portion, each side portion extending across a side of the nose, the side surface of the seal being soft to conform to the wearer's nasal surface under internal pressure, including an outer surface of the side portion of the seal conforming to the nasal side, including an outer side comprising a plurality of regions much harder than the soft inner side, these regions extending into the plurality of side portions of the seal.

According to another aspect, the side portions of the seal are substantially parallel to each other and substantially normal to the center portion of the seal.

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

According to another aspect, the seal includes a pair of nose locators on the side of the contact face, and the seal is harder in the area immediately adjacent to and including these nose locators than in the area surrounding this area (on the side of the contact face of the seal).

According to another aspect, the periphery of the seal, which connects the side of the contact face to the outer side, is flexible and allows the inner side of the seal to shift relative to the outer side.

According to another aspect, the outer side of the central portion of the seal includes a hole for allowing gas to enter and exit the interior of the seal.

According to another aspect, the flexible portion of the seal comprises a silicone material with a thickness between 0.05 mm and 0.5 mm.

According to another aspect, the flexible portion of the seal comprises an elastomer having a thickness between 0.1 mm and 0.2 mm.

According to another aspect, the rigid portion of the seal comprises a silicone material with a thickness between 2 mm and 5 mm.

According to another aspect, the flexible portion of the seal comprises an elastomer having a thickness between 2 mm and 3 mm.

According to another aspect, the area adjacent to and including these nose positioning elements comprises a silicone material with a thickness between 0.5 mm and 2 mm.

According to another aspect, the seal has a total width between 30 mm and 60 mm from the outer surface of one side portion to the outer surface of the other side portion.

According to another aspect, the seal has a total depth between 40 mm and 65 mm from the outer surface of the central portion to a line connecting the very end of each side portion.

According to another aspect, a body is assembled onto the nasal seal, the body being formed of a material harder than the nasal seal, and together with the nasal seal, forms a housing having an air inlet and a patient air outlet, wherein a rotating elbow is connected to the air inlet.

According to another aspect, the swivel joint connected to the body provides rotation of the swivel joint relative to the body, and the swivel joint pivots relative to the body about at least one transverse axis.

According to another aspect, the connection includes a ball joint.

According to another aspect, the elbow includes a first end and a second end, and a flow path between the first end and the second end, the flow path being aligned with the first end in a first direction and with the second end in a second direction, and the first direction and the second direction including an angle between 120° and 180°.

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

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

According to another aspect, the elbow includes a gas flushing outlet.

According to another aspect, the gas flushing outlet is aligned with a gas flow path that enters the elbow from the nose seal and body assembly.

According to another aspect, the gas flushing outlet includes multiple holes through a wall of the elbow.

According to another aspect, the patient interface includes a body assembled to the seal, and a strip extending in a loop from the assembled body and the nasal seal, the strip originating at one end from a first portion of the assembled body and the nasal seal and at the other end from a second portion of the assembled body and the nasal seal.

According to another aspect, the band includes a single, unseparated band along the length of the band that engages with the wearer's head.

According to another aspect, the strip is attached to the body at either end.

According to another aspect, the strip is coupled to the body at either end by a releasable connector.

According to another aspect, the band is narrow, preferably less than 10 mm wide.

According to another aspect, the band is less than 6mm wide.

According to another aspect, the belt has a stiffness of less than 2 N per 100 mm when extended from a relaxed state.

According to another aspect, the band is formed of a woven or braided yarn that combines filaments made of a highly elastic material with filaments made of a much stiffer material.

According to another aspect, the patient interface includes a tube suspended from the seal and the body, and a tube support attached to the tube and connectable to the patient's neck or clothing.

According to another aspect, the tube support includes a collar that can be fastened around the wearer's neck.

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 a fastening arrangement that allows for the fastening of these end portions with a selected amount of overlap.

According to another aspect, the collar includes a third end portion and a fourth end portion, as well as a connector for connecting the third end portion to the fourth end portion.

According to another aspect, the connector is configured to release the third end portion from the fourth end portion when a tension greater than the release tension is applied across the connector, wherein the release tension is less than 10N.

According to another aspect, the width of the collar is between 30mm and 60mm.

According to another aspect, the collar has a core material and a covering material surrounding the core material.

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

According to another aspect, the covering material is a braided or woven natural fiber.

According to another aspect, the tube support includes a tether extending from the neck collar, wherein a connector is fixed to or can be fixed to the tube at one end.

According to another aspect, the tethering device includes a connector located at the outer end, through which the collar passes.

According to another aspect, the tether includes a first end and a second end, and a connector connecting the first end and the second end, the connector being configured to release when a tension higher than the release tension is applied, wherein the release tension is less than 10 N.

According to another aspect, the connector of the strip includes a first part and a second part, and in the engaged state, the first part can rotate relative to the second part.

According to another aspect, the connector used to engage with the tube includes a ring.

According to another aspect, the patient interface includes a body connected to the seal, and the body includes a nasal seal engagement portion, an air inlet, and at least one strip engagement portion, the nasal seal engagement portion engaging an outer side of the seal, and an annular strip extending from the strip engagement portion for securing the interface to the patient.

According to another aspect, the body includes two strip joint portions, each strip joint portion extending laterally away from the air intake opening from opposite sides of the air intake opening.

According to another aspect, each strip joint portion extends away from the air intake opening in a region where the strip joint portion overlaps with the outer wall of the seal.

According to another aspect, a central portion of the body defines a convex shape that generally mates with the convex shape of the outer wall of the body, wherein strip joint portions extend from the lateral ends of the central portion, and these strip joint portions extend away from the central portion at an angle that is aligned outwardly with respect to the generally convex shape.

According to another aspect, these strip joint portions extend away from the outer wall of the seal at an angle greater than 30 degrees between them.

According to another aspect, the distance between the strip joint portion and the point where it deviates from the outer wall of the seal is a length between 50% and 150% of the equivalent length of the outer wall of the seal.

According to another aspect, the patient interface includes a body that engages with the nasal seal, the body being more rigid than the nasal seal, wherein a lip support is suspended from the body and extends beyond one edge of the seal.

According to another aspect, the lip support includes one or more pads for abutting against the upper lip portion of the wearer.

According to another aspect, the lip support includes two suspension legs spaced apart in any lateral region of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

According to another aspect, each leg carries a pad portion that is oriented to provide a surface against the upper lip.

According to another aspect, these legs are shaped to have lower stiffness around an axis parallel to the wearer's lips, rather than around an axis normal to the lip plane.

In another aspect, the invention can be generally described as a headgear for a patient interface, the headgear comprising an elastic band having a width between 3 mm and 6 mm, providing a tensile stiffness of 150 mm with a force of less than 2 N, a first end connected to or connectable to a first lateral portion of a face mask, and a second end connected to or connectable to a second lateral portion of a face mask.

According to another aspect, the strip is between 350mm and 450mm in terms of its slack length.

According to another aspect, when a tensile force of 1N is applied, the increase in the strip length is between 60mm and 110mm.

According to another aspect, the band is made of a woven or braided yarn, wherein the yarn comprises filaments made of a first material and filaments made of a second material that is highly elastic but much less rigid than the first material.

According to another aspect, the strip includes a first connector located at the first end and a second connector located at the second end.

In another aspect, the invention relates to a patient interface comprising a strip as described in any of the preceding paragraphs.

In another aspect, the invention can be summarized as a patient interface comprising a nasal seal, a body assembled to the nasal seal, and a lip support suspended from the body and extending beyond an edge of the seal. The nasal seal includes a side that contacts the face and is formed of a soft, flexible material. The body is formed of a harder material than the nasal seal and together with the nasal seal forms a housing having an air inlet and a patient air outlet.

According to another aspect, the lip support includes one or more pads for abutting against the upper lip portion of the wearer.

According to another aspect, the lip support includes two suspension legs spaced apart in any lateral region of the seal, each leg extending beyond a lateral portion of the lower edge of the seal.

According to another aspect, each leg carries a pad portion that is oriented to provide a surface against the upper lip.

According to another aspect, these legs are shaped to have lower stiffness around an axis parallel to the wearer's lips, rather than around an axis normal to the lip plane.

According to another aspect, the patient interface includes a gas supply tube suspended from the body and a strip extending in a loop from the assembled frame and nasal seal, the strip originating 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.

In another aspect, the invention can be summarized as a patient interface comprising a face mask, a tube suspended from the face mask, and a tube support connected to the tube and including a collar that can be fastened around the wearer's neck.

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 a fastening arrangement that allows for the fastening of these end portions with a selected amount of overlap.

According to another aspect, the collar includes a third end portion and a fourth end portion, as well as a connector for connecting the third end portion to the fourth end portion.

According to another aspect, the connector is configured to release the third end portion from the fourth end portion when a tension greater than the release tension is applied across the connector, wherein the release tension is less than 10N.

According to another aspect, the width of the collar is between 30mm and 60mm.

According to another aspect, the collar has a core material and a covering material surrounding the core material.

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

According to another aspect, the covering material is a braided or woven natural fiber.

According to another aspect, the tube support includes a tethering member extending from the neck collar, wherein a connector at one end is fixed to or can be fixed to the tube.

According to another aspect, the tethering device includes a connector located at the outer end, through which the collar passes.

According to another aspect, the tether includes a first end and a second end, and a connector connecting the first end and the second end, the connector being configured to release when a tension higher than the release tension is applied, wherein the release tension is less than 10 N.

According to another aspect, the connector of the fastener includes a first part and a second part, and in the engaged state, the first part can rotate relative to the second part.

In another aspect, the invention can be summarized as a patient interface comprising a nasal seal, a body attached to the seal, and a strip. The nasal seal includes a face-contacting side, is formed of a soft, flexible material, and includes a central portion extending across the base of the nose and a side portion extending from each end of the central portion, each side portion extending across a side of the nose. The body includes a nasal seal engagement portion engaging an outer side of the seal, an air intake opening, and at least two strip engagement portions, each strip engagement portion laterally extending from an opposite side of the air intake opening away from the air intake opening, the strip extending between these strip engagement portions.

According to another aspect, each strip joint portion extends away from the air intake opening in a region where the strip joint portion overlaps with the outer wall of the seal.

According to another aspect, a central portion of the body defines a convex shape that generally mates with the convex shape of the outer wall of the body, wherein strip joint portions extend from the lateral ends of the central portion, and these strip joint portions extend away from the central portion at an angle that is aligned outwardly with respect to the generally convex shape.

According to another aspect, these strip joint portions extend away from the outer wall of the seal at an angle greater than 30 degrees between them.

According to another aspect, the distance between the strip joint portion and the point where it deviates from the outer wall of the seal is a length between 50% and 150% of the equivalent length of the outer wall of the seal.

As used in this specification and claims, the term "comprising" means "consisting of at least a portion of...". When interpreting a statement containing the term "comprising" in this specification and claims, features other than those prefixed with that term may also exist. Related terms such as "comprise" and "comprises" will be interpreted in the same manner.

In this specification, references have been made to patent specifications, other external documents, or other sources of information, generally to provide background for discussing the features of the invention. Unless otherwise expressly stated, references to such external documents should not be construed as an admission that such documents or such sources of information in any jurisdiction are prior art or constitute part of common knowledge in the art.

Attached Figure Description

Preferred embodiments of the invention will be described with reference to the accompanying drawings.

Figure 1 is a perspective view of a person wearing a patient interface.

Figure 2 is a perspective view of the patient interface of Figure 1 without a patient.

Figure 3 is an exploded view showing the multiple components that make up the interface in Figure 2.

Figures 4A through 4C show a sealing component of the patient interface of Figure 2 from different angles. Figure 4A shows the sealing component from an outward-facing side, Figure 4B shows the sealing component from a patient-facing side, and Figure 4C shows a side view of the sealing component.

Figure 5A is an exploded view of the seal and mask frame, showing how to put them together for assembly.

Figure 5B is a side view of the interface of Figure 2, partially disassembled to show the connection between the elbow and the mask frame.

Figure 5C is a front perspective view of the interface of Figure 2, showing the assembly of the elbow with the mask frame, with a gas flushing outlet present in the elbow.

Figure 6 is a front view of the assembled seal and mask frame.

Figure 7A is a top view of the seals and mask frame of the assembly.

Figure 7B is a side view (not cut) of the seal and frame of Figure 7A.

Figure 7C is a view of the seal on the patient side of Figures 4A and 4C.

Figure 7D is a side view of the seal of Figure 7C cut through line EE.

Figure 8 is a side view of the seal and mask frame of Figure 7A taken by line DD.

Figure 9A is a top view of the seal of Figure 7C cut through line FF of Figure 7D.

Figure 9B is a top view of the seal of Figure 7C cut through line GG of Figure 7D.

Figures 10 and 11 show views of another embodiment of the interface with an inflatable nasal seal and frame. The seal is shaped to wrap around the user's nose.

Figure 12 shows the seals of Figures 10 and 11 after the frame has been removed.

Figure 13 shows another embodiment of the interface with an inflatable seal. The interface includes a seal body, a frame, a conduit, and a head strip.

Figure 14 shows the sealing body of the interface in Figure 13.

Figure 15 is a perspective view of the interface frame and seal body of Figure 13.

Figure 16 is a front view of the frame and seal body of the interface in Figure 13.

Figure 17 is a side view of the frame and seal body of the interface in Figure 13.

Figure 18 is a cross-section of the frame and seal body of BB in Figure 17.

Figure 19 is an alternative cross-sectional view of the seal body.

Figure 20 is a cross-section of the seal body of AA in Figure 16.

Figure 21 shows an alternative embodiment of a sealing body for the interface of the present invention.

Figure 22 shows yet another embodiment of a sealing body of the interface of the present invention.

Figure 23 shows another embodiment of a sealing body of the interface of the present invention.

Figure 24 shows a first embodiment of a header strip that can be used with the interface of the present invention.

Figures 24a and 24b show two alternative cross-sections of the head strip of Figure 24.

Figure 25 shows a second embodiment of a header strip that can be used with the interface of the present invention.

Figures 25a and 25b show two alternative cross-sections of the head strip of Figure 25.

Figure 26 shows a third embodiment of a header strip that can be used with the interface of the present invention.

Figure 27 shows a fourth embodiment of a header strip that can be used with the interface of the present invention.

Figure 27a shows the extendable portion of the head strip of Figure 27 in both extended and contracted states.

Figure 28 shows a fifth embodiment of a header strip that can be used with the interface of the present invention.

Figures 29 and 29a show a sixth embodiment of a header strip that can be used with the interface of the present invention.

Figure 30 shows a first embodiment of the connection of the interface of the present invention between a sealing body and a frame.

Figure 31 shows a second embodiment of the connection of the interface of the present invention between a sealing body and a frame.

Figure 32 shows a third embodiment of the interface of the present invention connecting a sealing body and a frame.

Figure 33 shows a fourth embodiment of the connection of the interface of the present invention between a sealing body and a frame.

Figure 34 shows a first embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 35 shows a second embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 36 shows a three-fold embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 37 shows one four-fold embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 38 shows one embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 39 shows a six-fold embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 40 shows one embodiment of a strap that can be used with the interface of the present invention to secure a pipe connected to the interface to a user.

Figure 41 is a perspective view of a neck brace.

Figure 42 is a perspective view of a patient wearing the support neck collar of Figure 41.

Figure 43 is a perspective view of the collar in Figure 41 from a different angle.

Figure 44 is a front view of a patient wearing the neck collar shown in Figure 41.

Figure 45 is a top view of the collar in Figure 41.

Figure 46 is a top view of a portion of the neck collar of Figure 41, showing an arched fastener connector.

Figure 47 is a top view of a portion of a collar including an alternative fastener.

Figure 48 is a top view of a portion of a collar including an alternative fastener.

Figure 49 is a top view of a portion of a collar that includes an additional alternative fastener.

Figure 50A is a side view of a portion of a collar including a retaining buckle in an engagement configuration.

Figure 50B is a side view of this portion of the collar in the disengaged state, derived from Figure 50A.

Figure 51A is a side view of a portion of a collar including a retaining clip in a disengaged state according to an alternative embodiment.

Figure 51B is a side view of this portion of the collar of Figure 51A in the engaged state.

Figure 52 is a perspective view of a tethering element suspended from a portion of the collar, wherein the tethering element includes a quick-disconnect connector.

Figure 53 is a perspective view showing a tethering element suspended from the collar, which includes a quick-disconnect connector that can also rotate.

Figure 54A is a top view of a tethering device similar to that in Figure 51B but with a minimum length.

Figure 54B is a top view of the fastening element of Figure 54A, in which the quick-release connector is disengaged.

Figure 54C is a side view of the fastening element in Figure 54A.

Figure 55 is an exploded view showing the connection of the tethering ring from the support collar to a catheter.

Figure 56 is a perspective view of an interface, including an alternative arrangement for supporting the catheter from the patient.

Figure 57 is a perspective view of a patient wearing an interface, including an alternative arrangement for supporting the catheter on the patient.

Figure 58 is a side view of a frame and seals, which are joined to a plurality of suspended lip stabilizers according to a further invention herein.

Figure 59 is a top view of the frame and seals in Figure 58.

Figure 60 is a front view of the frame and seals of Figure 58.

Figure 61 is a perspective view of an interface combining the frame and seal of Figure 58.

Figure 62 is a graph showing the effect of the tested tensile force on the tensile strength of the sample strip material.

Detailed Implementation

One invention herein provides an interface comprising an inflatable nasal seal having a soft wall structure. The inflatable seal has a pair of positioning protrusions that engage in the user's nostrils. These positioning protrusions supply gas from within the seal to the user. The patient side of the seal is so soft and of sufficient size and shape that when the inflatable seal is pressed against the user's face, where the positioning protrusions engage in the user's nostrils, the seal conforms to the surface of the user's face (specifically, the sides of the nose and upper lip) and provides a seal. One outward-facing wall of the seal is more rigid and supports the inner wall of the seal at a location surrounding the wearer's nose.

The seal is formed from a material with sufficient elasticity and yield strength to make the seal flexible. This flexible portion can withstand repeated, intense deformation without damage. Possible materials include latex, vinyl resin, silicone, and polyurethane. Typically, the wall thickness of the flexible portion of the seal should be less than 0.5 mm and can be less than 0.2 mm.

The sealing body includes a pair of nasal positioning elements projecting from the patient-facing wall. Preferably, these nasal positioning elements are integrally formed with the sealing body. Each nasal positioning element includes an outlet for supplying gas from inside the sealing housing to the user wearing the interface.

The seal body includes an air intake opening that is generally opposite to these nose positioning elements.

The substantial portion of the seal body or envelope is soft. The areas adjacent to and including these nose locators, and the areas adjacent to and including the air intake opening, are much harder. These areas maintain the overall shape of the seal and may have any suitable hardness. In this way, they can be formed from a harder material, or formed thicker of the same material as the rest of the envelope.

The seal is supported by a mask body or frame. The air inlet of the seal is adapted to the frame or directly to a duct extending through the frame.

The frame is preferably a minimal design to provide minimal visual obstruction, allowing for a clear field of vision and allowing the user to wear glasses while wearing the interface.

The frame can be formed by injection molding, for example, from an elastomeric material such as silicone or polyurethane. Alternatively, a rigider material, such as polycarbonate or polyester, polystyrene, or nylon, can be used.

The preferred frame includes a plurality of connection points for attaching the strips to the frame. These strip attachment points are provided for anchoring the strips. These strip attachment points can also be provided for adjusting the length of the strips.

In other forms, the nose seal body may include integral strip attachment points. These attachments may be connecting elements on the surface of the envelope. However, they may be integral strips or flaps formed within the envelope and extending from either side of the envelope.

The interface is intended to be supported by a single strip that runs around the back of the head. This strip can be formed from an elastic or elastomeric material. Suitable strip materials could include a woven elastic strip or a narrow strip made of foam and fabrics such as Breathoprene™. The strip extending around the back of the head provides pressure to the mask and helps maintain the seal against the user's face.

A hose extends from the frame. This hose delivers breathable gas. The distal end of the hose is connected to the main CPAP delivery tube.

A connector can connect the tube and the frame. The connection mechanism can be any suitable connection. This can include snap-fit, hooks in silicone, keyhole inserts, overmolding, insert molding, screw attachment or adhesive, or any combination thereof.

The connector may include a flow-limiting outlet (or deflection outlet) for providing gas flushing from the interface. The outlet may be in the form of an assembly of multiple orifices within the connector. Internally, the connector may include a funnel or extension that guides gas from the outlet into the suffix opening.

Figures 1 and 2, in conjunction with the invention disclosed in this application, illustrate an exemplary patient interface. For clarity, Figure 2 shows the patient interface separate from the patient, and Figure 1 shows it being worn on the patient.

In summary, the patient interface 101 includes a mask 103, a strap 105 for securing the mask to the patient, a flexible supply catheter 107 connected to the mask 103, and a catheter support structure 109 attached to the patient and supporting the weight of the catheter portion 107 and any connecting catheters at the inlet end 111 of the catheter portion 107 that supply gas.

Referring to other figures, several specific aspects of this patient interface, and variations thereof, will be discussed. An interface may combine some aspects rather than others. For example, an interface may combine multiple aspects of the mask when using different arrangements to secure the mask to the user. An interface may include a different mask when securing the mask to the user using multiple aspects of the inventive strip. An interface may combine multiple aspects of the mask but not use a similar structure or any structure for supporting the weight of the catheter from the patient's body. All these variations are considered within the scope of this application.

Referring to Figure 1, the mask 103 is fitted over the patient's nostrils and includes lateral portions that curve around either side of the nose. These lateral portions are designed to form a peripheral seal on the outward-facing side of the nose. A strip 105 encircles the user's head in the form of a single loop located above the user's ears.

The catheter portion 107 is suspended from a central connection 113 located in front of the mask 103. This central connection 113 is preferably a swivel joint, such that the path of the catheter relative to the mask on the patient's face can be adapted to the patient's sleeping position. The swivel joint may be in the form of a ball joint, allowing it to pivot about an axis parallel and perpendicular to its connection with the mask.

The catheter stent 109 shown includes a neck collar 115 that is attached around the user's neck. A tether 117 is attached between the neck collar and the catheter 107.

Figure 3 illustrates the constituent components of this exemplary interface. The face shield 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 will be explained in more detail with reference to Figures 5A and 8.

The body 303 includes a socket 305 and a plurality of connector portions 307. The socket 305 receives an engagement portion 311 of an elbow 333. The elbow 333 is connected to the end of a hose 315. The other end of the hose 315 is terminated with a sleeve 317. The connector portions 307 of the mask body 303 are for engaging with connector portions 321 of a head strap 105. The head strap 105 includes a single segment 323 made of a stretchable material. The connector portions 321 are provided at either end of this segment 323.

The neck collar 115 includes a band 325 made of a material intended to feel comfortable when worn during a sleep cycle. The band includes a first adjustable connection 327 and a second non-adjustable connection 329. At the adjustable connection 327, the free ends of the band overlap, and the degree of overlap can be changed to and secured to a desired amount. At the non-adjustable connection 329, the free ends of the band can be easily secured or released. Once the adjustable connection 327 has been adjusted, the neck collar can be opened to fit onto the patient or removed from the patient, and secured after fitting onto the patient (by disconnecting or connecting the non-adjustable connection 329). The non-adjustable connection 329 can be a quick-release connector, which can be disconnected by applying tension within a predetermined range. This ensures that the neck collar will be released without harming the patient in the event of an adverse condition.

The tethering element 109 includes a first portion 331 attached to the collar and a second portion 333 attached to the catheter. These portions are preferably releasably engaged by another quick-release connector, which preferably disengages when a tension within a predetermined range is applied.

The tethering portion 333 is connected to the catheter 315. The tethering portion 333 includes a portion of the quick-release connector and a fitting 337 that engages the catheter. The fitting 337 may be an open snap that engages a recess in the corrugation of the catheter or the cuff 317, or engages around the generally cylindrical catheter, or engages a cylindrical portion of the cuff. Alternatively, and as shown, the portion 337 may include a ring that adapts to around a portion of the catheter or a portion of the cuff. In this illustrated embodiment, the ring 337 is captured between the cuff 317 and a connector portion of a swivel 335. The ring adapts to a portion 339 of the cuff 317 and is held captured by an end portion 341 of the swivel 335, which has a diameter larger than the inner diameter of the ring.

Figures 4A to 4C illustrate the shape of a preferred seal. The 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. In general, the seal wall forming the patient-facing side is very flexible, except for the nasal locators, the area immediately adjacent to them, or both. The variation in flexibility will be illustrated in more detail with reference to the cross-sections shown in Figures 7D, 8, and 9A and 9B.

In terms of overall shape, the seal has a central portion that includes multiple nasal positioning elements on the patient-facing side and an opening 403 on the outward-facing side. The extent of this central portion 407 is shown in general by a broken line 409 in Figures 4C and 4A. For clarity, the broken line 409 is also included in Figure 7A, which includes a top view of the mask portion of the interface.

Multiple lateral or side portions 411 extend from the central portion 407. Each side portion includes an outward face 413 and an inward face 415, as well as a peripheral edge portion 417 connecting the inward face portion and the outward face portion. The peripheral edge portion 417 extends around a top edge 419, an end edge 423, and a lower edge 420. Thus, when viewed from the inside of the seal, these side portions 411 resemble a pocket.

Each side portion is quite extensive. Preferably, the side portion extends more than 10 mm (most preferably more than 20 mm) or extends such a distance that is at least 70% of the distance by which the center of the nostril locator 401 is separated from the base of each nostril locator.

At least the inner wall 415 and peripheral wall 417 of each side portion are very flexible, so that they can conform to the contours of the user's face, and specifically, to the outer contours of the side of the user's nose. At least several portions of the outward-facing wall 413 of the side portion are also flexible, but become less flexible as they move toward the central portion 407.

The central portion 407 of the seal includes an opening 403 to allow gas to flow in and out of the mask body 303. The opening 403 may include multiple features, such as lips and/or channels that engage with multiple features (e.g., channels and/or lips on the body 303). The opening 403 may be formed together with snap-fit portions, or these snap-fit portions may be attached to or overmolded to the periphery of the opening 403 to facilitate engagement with the frame 303. Typically, the opening 403 will be substantially thicker and harder than the soft sealing portion of the seal 301. The opening 403 should be at least the size of the internal cross-section of the supply conduit 315. Preferably, and as shown, the opening 403 is the same size as the extent of the mask body 303, which is the same as the total width of the interface and approximately the same as the width of the intended wearer's nose.

In a preferred form, the interface is expected to be small in size and the body portion 303 of the mask is curved to approximately conform to the contour of the wearer's upper lip and to form a seal such that the opening 403 conforms to the general curve of this design.

The central portion 407 of the seal extends above and below the opening 403. Above the opening 403 and the nostril locators 401, the central portion includes an outward-facing wall 431, an inward-facing wall 433, and a peripheral portion 435. Preferably, at least the inward-facing wall portion 433 and the outward-facing portion 435 are thin and flexible.

Below the opening 403, the central portion 407 includes an outer wall portion 441, an inner wall portion 443, and a surrounding portion 445. Preferably, at least the inner portion 443 and the surrounding portion 445 are thin and flexible.

In use, the internal pressure of the seal (from the flow of gas supplied to the patient interface) causes the soft inner wall portions of each of these nasal positioning elements to expand above, below, and above, pressing against the wearer's skin and conforming to the contours of the outer side of the wearer's nose, the surface below the wearer's nose, and the surface of the wearer's upper lip just below the nose. Movement of the mask body does not disrupt this seal because the soft periphery or surrounding area of the seal allows the mask body to move at least a small range in the direction of movement. This soft periphery separates the positions of these nasal positioning elements from the position of the mask body, allowing the mask body to shift 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 additional seals against them, supporting the positioning of the mask.

The mask body and seal are illustrated in larger form in Figure 5A and in Figures 5B and 5C. As previously described, the seal includes an opening 403, which is secured to the mask body in various arrangements. The mask body includes a socket 502 for connection to the supply conduit and a sealing opening 501 for engagement with the opening 403 of the seal. The sealing opening 501 and the sealing opening 403 are equipped with complementary features to engage them together. In the illustrated form, the sealing opening 403 includes an arrangement 507 of lips and channels, and the sealing opening 501 of the mask body includes a complementary arrangement 505 of these channels and lips. These channel and lip arrangements are designed to ensure that there is no leakage at the connection when the seal is properly fitted to the mask body and gas is supplied under pressure. Various other ways can be designed to connect the seal and the mask body, and this arrangement is merely illustrative.

In the mask body, the vent opening 501 for the seal is directly opposite the opening of the socket 502, thus centrally positioning the opening 502. A central side portion 509 extends from either side of the socket 502. This central side portion 509 can be a flat cover wall that surrounds a portion of the opening 403 of the seal. These central side portions 509 include a plurality of small orifices as part of a gas flushing outlet.

In the preferred embodiment shown, the side arms 511 extend beyond the extent of the closure opening 501 (best shown in FIG. 7A), and these side arms 511 preferably extend beyond the maximum width of the seal. Each side arm 511 includes a connector portion 513 for attachment to the connector portion 321 of the strip. In the illustrated embodiment, these connector portions include a retaining post having a peripheral undercut. The strip has a small loop formed at each end that extends beyond the retaining post and engages in the undercut. This connector form is simple and intuitive, but other connector forms can be provided, such as each side arm 511 being equipped with a snap-fit portion (e.g., a convex or concave portion).

Ideally, as shown in Figure 7A, these side arms 511 are offset from the outer wall of the seal (e.g., at an angle 713 between 30° and 80°). At a location spaced apart from the seal and from the wearer's face, a strip fixed to the post 513 provides such a side arm in a manner illustrated by line 715 in Figure 7A. This is shown by the relative position of the tip 717 of the side arm 511 to the centerline 719 of the interface. The distance 721 from the centerline to the tip of the side arm is preferably between 25 mm and 50 mm, and most preferably approximately 45 mm. This is compared to the distance 723 between the centerline 719 and the central axis of the nose locator, which is preferably between 5 mm and 10 mm, and most preferably approximately 7 mm. It is also compared to the approximate location of the inner wall surface of the side portion of the seal, where the central portion of the seal is located. This location is shown by the broken line 725 in Figure 7A. Preferably, this separation 727 is between 10 mm and 20 mm, and most preferably about 15 mm. For further comparison, the outermost extent of this side portion is shown by the zigzag line 729. The displacement 731 of the zigzag line 729 from the center line 719 is preferably between 15 mm and 30 mm, and most preferably about 25 mm.

In the front-to-back direction, the tips 717 are preferably located at the rear of the base of these nose positioning elements, such that the base of these nose positioning elements is located between the central portion of the mask body and a line connecting these tips 717.

Referring further to Figure 7A, the mask seal can generally have a maximum outer range 741 between 30 mm and 60 mm, and most preferably about 50 mm. The seal and mask frame can have a total depth 743, preferably between 40 mm and 65 mm, and most preferably about 55 mm. Within this depth, the internal space defined by the seal (which, in use, surrounds the user's nose) can have a depth 745, preferably between 20 mm and 40 mm, and most preferably about 30 mm.

As can be seen from Figure 7A, in its overall form, the seal bends through a significant arc, such that the side portions are generally parallel to each other and lateral to the space receiving the nose. The orientation planes of these side portions can together form an angle between 0° and 45°, and preferably between 0° and 25°. Preferably, this applies to both the inner and outer walls (as shown in Figures 9A and 9B). Preferably, this is also true for substantially all vertical displacement levels within the seal (as illustrated by the different levels shown in Figures 9A and 9B).

The overall design shape of the seal (as shown in Figure 7A) can be considered parabolic, semi-elliptical, semi-oval, or U-shaped. Overall, the central portion of the seal defines the width of the seal, wherein the side portions of the seal extend from the lateral ends of the central portion in a direction that is substantially parallel to each other and substantially perpendicular to the width dimension.

Figures 5B and 5C also show the connection between the swivel elbow 313 and the mask body 303. The swivel elbow 313 includes a spherical portion 515 and an opening 517. The outer surface of the spherical portion 515 is preferably a frustosphere, but can be modified to still achieve a substantial seal with the socket 502. Similarly, the socket 502 is preferably a frustosphere with a slightly protruding lip. This is best shown in Figure 8, where the lip 802 slightly protrudes relative to the remaining frustosphere surface 804.

The swivel bend 313 preferably defines an angle between 0° and 90°, more preferably between 30° and 60°, and most preferably about 45°, between the flow in the conduit and the flow through the connection to the mask. The bend may incorporate a plurality of orifices 519 that form part or all of the gas flushing outlet for the patient interface. These orifices are preferably located on the outside of the bend, substantially along the flow path of the gas exiting the mask.

Figures 5B and 5C also show the connector portion 321 of the strip, which engages with the post 513 of the mask body.

Figures 7A to 7D show the background of the cross-sections shown in Figures 8, 7D, 9A, and 9B.

Figure 7D is a cross-section through line EE of the seal of Figure 7C. Figure 7D shows the thickness of several portions of the seal in the vertical center plane of the seal. This shows the thickening of the seal in region 731, which is adjacent to and located between these nostril locators. The cross-section also shows the thickening of the seal in the outer wall portion 431 of the central portion above the outlet 403 and in the outer wall portion 441 of the central portion below the opening 403. These thickened areas preferably gradually increase in thickness from the thin and soft peripheral portions 435 and 445 to approximately 2 mm to 4 mm. These soft wall portions (which are the peripheral portions 435 and 445, the lower inner wall portion 443, and the upper inner wall portion 443) preferably have a wall thickness between 0.05 mm and 0.5 mm, and most preferably between 0.1 mm and 0.2 mm.

The portion 731 between these nose positioning elements preferably has a thickness between 2 mm and 0.5 mm, and more preferably between 0.8 mm and 1 mm.

These dimensions are given for silicone materials with a Shore A hardness of approximately 40. If the seal is formed of other materials, the same size variation is possible while still maintaining the flexibility of the seal in these areas. Preferably, it is soft and retains sufficient rigidity to provide form for the seal in these areas where the desired shape is to be provided.

Figure 8 is a cross-section of the mask seal and body DD of Figure 7A. This shows a cross-section of the central portion of the seal on the outward side, as shown and illustrated with reference to Figure 7D, but also shows the connection between the seal opening and the opening of the mask body. However, the cross-section of Figure 8 also shows a preferred cross-sectional form of a nose positioning element. Specifically, the material thickness of the wall 806 of the nose positioning element is preferably between 0.5 mm and 2 mm, and most preferably between 0.8 mm and 1 mm.

The nose positioning device includes a base portion 808 and a nozzle portion 810 having a central opening 812. The portion including the opening 812 adapts to the interior of the user's nostrils. The base portion 808 provides primary positioning at the entrance to the nostrils.

Figure 9A is a cross-section of the seal through line GG in Figure 7D. This is a cross-section of the seal approximately on the horizontal center plane through the nostril locators. This cross-section shows that the wall portions 806 of the nostril locators, the adjacent regions 902 outside the periphery of the nostril locators, and the central portion 731 between the nostril locators all have a thickened wall relative to the soft wall portions 415 and 423 of the side portions of the seal. Specifically, the regions adjacent to and including the nostril locators preferably have a thickness between 0.5 mm and 2 mm, and most preferably between 0.8 mm and 1 mm.

Compared to the portions near these nostril positioning elements, the outer wall portion 413 of the side portion of the seal is also substantially thicker. These portions preferably have a thickness between 2 mm and 5 mm, and most preferably between 3 mm and 5 mm. These portions gradually decrease in thickness to achieve a soft thickness, at which point they become the surrounding portions 423.

The thickened portion of the outer wall 413 of these side portions preferably extends within 10 mm of the farthest tip of the side portion.

The thickening and rigidity of these outer portions 413 provide the seal with substantial shape and stability when in place. When the seal is inflated under supply pressure, the sidewalls counteract the outward bending of the side portions of the seal, while the wall portions 413 will bend outward under pressure and have sufficient reaction force to keep the seal wrapped around the wearer's nose.

The stiffening produced by the thicker area of the seal can be provided by a composite material or a combination of components. For example, stiffness can be provided by reinforced silicone or by a flexible insert made of a rigid material. The insert made of a rigid material can be integrated into the mask body. Preferably, the construction is such that multiple side portions of the seal provide bending resistance, wherein an effective stiffness of at least 1 N force at the end of the stiffened region is sufficient to bend the side portion through an angle of approximately 60°.

Figure 9B shows another, substantially horizontal plane above the cross-section of Figure 9A. This cross-section is taken through line FF of Figure 7D. This again shows the thickness of the outer wall portion 413 of the side portion of the seal relative to the thickness of the inner wall portion 415 and the peripheral portion 423, and relative to the thickness of the upper inner wall portion 433.

Furthermore, these side portions 413 preferably have a thickness between 2 mm and 5 mm, and most preferably between 5 mm and 3 mm. These flexible portions 415, 423 and 433 have a thickness between 0.05 mm and 0.5 mm, and most preferably between 0.1 mm and 0.2 mm.

Figures 10 to 12 show another example of an interface with this type of seal. The interface includes a seal body 1000. The seal body 1000 includes a seal sleeve 1001. The seal body 1000 has a curved shape to conform to the contours of a human face. The seal body 1000 has an inner surface 1002 and an outer surface 1003. The inner surface 1002 includes nose positioning elements 1004 and 1005. The nose positioning elements 1004 and 1005 each have multiple outlets for allowing air to pass to the user. In use, the inner surface 1002 is pressed against the user's face and the nose positioning elements 1004 and 1005 extend into or around the user's nostrils.

The seal body 1000 is shaped to wrap around the user's nose. The seal body 1000 has multiple side portions or flaps 1006 and 1007 that extend fully across the sides of the user's nose and may also extend at least partially across the user's cheek. The seal body 1000 curves in the area near the user's bridge of the nose and does not extend beyond this area. Effectively, the seal body has a cutout area 1008. This cutout area 1008 indicates that during use, the seal body does not apply pressure to the user's bridge of the nose area (an area where pressure sores may typically occur on the user at the interface extending across the user's bridge of the nose).

The seal body 1000 includes an air inlet or gas supply port 1009. The air inlet 1009 is opposite to the nose locators and receives a frame 1010. The frame 1010 is bent to fit the seal body and provide support for it. The frame 1010 includes a connector 1011 that, in use, is attached to a conduit (e.g., conduit 114 as shown in Figures 1 and 2) that receives pressurized gas to supply the user.

The frame 1010 is made of a plastic material. This plastic material can be a flexible material or a more rigid type of material. For example, the frame can be made of polycarbonate. Alternatively, the frame can be made of a more flexible material (such as silicone).

In use, pressurized gas is supplied to the seals of Figures 10-12 via a conduit and a connector 1011 on frame 1010. This gas inflates the seal body 1000 and presses it against the user's nose and surrounding area. Nose positioning elements 1004 and 1005 create a seal in or around the user's nostrils, and then pressurized gas enters the user's nostrils through positioning element outlets 1012 and 1013.

The frame or seal body includes at least two strip connectors (not shown) similar to those described above. These connectors allow a head strip to be attached to the interface 1000. The head strip can extend around the back of the user's head and provide additional tension on the interface to help seal the interface to the user's face.

The seal body is made of a flexible material. Examples of possible materials include latex, vinyl resin, silicone, and polyurethane. In a preferred embodiment, the outer wall 1003 of the seal body is shaped to be thicker in cross-sectional material than the inner surface 1002. The thicker outer wall of the seal body maintains its predetermined shape while the inner wall can be bent to conform to the surface of the wearer's face.

Figures 13 to 20 show another embodiment of an interface having a sheath surrounding an inflatable seal. The interface 1100 includes a seal body 1101 similar to the embodiment of Figures 10 to 12, and a frame 1102. As described above with reference to Figures 10 to 12, the frame 1102 is fitted onto the seal body 1101 in the same manner.

Attached to frame 1102 is a conduit 1112, which is attached to a gas supply device. This conduit supplies gas to the mask frame and seals. Conduit 1112 can be secured to the user (wearing interface 1100) via a lanyard 1113. In use, the lanyard 1113 extends around the user's neck. However, the lanyard 1113 is secured to the conduit using known methods, shown as a C-shaped clip 1114 attached to the lanyard 1113, which clamps around the conduit.

The interface 1100 is held in place on the user's nose by a headband 1114. This band is preferably made of a flexible material (such as silicone) or a laminated material well-known in the field of headbands. Each end of the band 1114 is preferably adapted to a snap fastener 1116, which is attached to a corresponding eyelet 1117 formed in or attached to the sealing body 1101. The band can be a planar silicone band, a small hollow silicone tube, or a suitable configuration known in the art.

The frame 1102 may have a plurality of deflection holes 1115 formed therein to allow the user's exhaled gas to escape from the interface. Alternatively, these deflection holes may be formed in the seal body 1101 to allow gas to escape.

The sealing body 1101 is also a soft or inflatable type of seal. The sealing body 1101 is curved in shape to conform to the contours of the human face and extends around the user's nose, thus wrapping around the user's nose. The sealing body 1101 preferably extends completely across the sides of the user's nose and may also extend partially across the user's cheek. The seal 1101 includes an inner wall having an inner surface 1103 and an outer wall having an outer surface 1104. Protruding from the inner surface 1103 are nose positioning elements 1105 and 1106, each nose positioning element having outlets 1107 and 1108.

In the embodiment of Figures 10 to 12, the sealing body 1101 includes an air inlet 1109 which is opposite to the nose positioning members 1105 and 1106 and receives the frame 1102.

The seal 1101 has a variable wall thickness, resulting in rigidity around the multiple portions of the protruding seal and flexibility between the nose locators 1105 and 1106 and the periphery 1110 of the air intake opening 1109 of the seal. This indicates a decoupling effect between the nose locators 1105 and 1106 and the periphery 1110 of the air intake (and subsequently with the mask frame 1102). This means that some movement of the mask frame will be possible without disrupting the seal of the nose locators 1105 and 1106 above or within the user's nostrils.

As shown in Figure 18, the air intake perimeter 1110 (which defines the air intake 1105 to the seal) has a substantially thick cross-section. This provides rigidity to the air intake perimeter 1110. Similarly, the nose locators 1105 and 1106 have substantially thick cross-sections. However, the thickness of these nose locators does not necessarily have to be equal to or thicker than the air intake perimeter 1110. In a preferred embodiment, the thickness of the locators is less than the thickness of the air intake perimeter.

Compared to both the area around the nose locator and the air inlet, the regions between the air inlet area 1110 and the nose locators 1105 and 1106 are preferably thinner in cross-section. For example, in Figure 18, the length of the seal 1101 between X and Y is formed to be significantly thinner in cross-section than the area around the air inlet or these nose locators. This means that the length is more flexible, thus effectively allowing more movement of the nose locators 1105 and 1106. Furthermore, when the length between X and Y (including the outer perimeter 1111) is thinner in cross-section, the seal will be easier to inflate to help seal the seal around the user's nose.

As shown in Figure 18, a region 1118 of the seal, preferably adjacent to the base or root of each nose locator, has a thickened cross-section. As shown, a preferred length or region 1119 of the seal is formed between region 1118 and the thickened air inlet perimeter 1110, which is significantly thinner in cross-section than the air inlet perimeter 1110, nose locators 1105 and 1106, or region 1118.

In an alternative embodiment, the envelope includes a thickened region 1118 adjacent to the base of the nose locators, and the cross-sectional thickness of the nose locators is not thickened. For example, the cross-sectional thickness of the nose locators may be similar to the thickness of the envelope region 1119 extending between the region 1118 adjacent to the nose locators and the area around the air inlet 1110. The thickened region 1118 adjacent to the base of the nose locators prevents the base of the nose locators from excessively deforming or expanding under typical CPAP pressure. However, in this embodiment, the thinner walls of the nose locators 1105 and 1106 can expand under CPAP pressure.

Preferably, the seal 1101 is formed of silicone having a Shore A hardness of approximately 40. Alternatively, other materials with similar properties can be used. For silicone with a Shore A hardness of 40, or other materials with similar properties, the thickness of the sealing region 1119 extending between these nose positioning elements and the air inlet is less than approximately 0.5 mm. Preferably, this region 1119 has a thickness of 0.1 mm to 0.2 mm. Alternatively, this region 1119 of the sealing can have a thickness of less than 0.1 mm, for example, 0.05 mm.

The thickness of the region 1118 near the base of these nose positioning elements is preferably less than 2 mm. Preferably, the thickness of the region 1118 near the base of these nose positioning elements is approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of the region 1118 near the base of these nose positioning elements may be less than 0.8 mm, for example, 0.5 mm.

The thickness of the area around the air intake is approximately 3mm to 5mm, but it can be thinner, for example, 2mm.

These nasal positioning elements have a thickness of less than 2 mm. In a preferred embodiment, these nasal positioning elements have a thickness of approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of these nasal positioning elements may be less than 0.8 mm, for example, 0.5 mm.

In the alternative embodiments described above, the thickness of these nose positioning elements is similar to the thickness of the sealing region 1119 extending between these nose positioning elements and the air intake. In this embodiment, the nose positioning elements preferably have a thickness of approximately 0.1 mm to 0.2 mm. Alternatively, the thickness of these nose positioning elements may be less than 0.2 mm, for example, 0.05 mm.

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

Referring now to Figure 20, which shows seal 1101 in cross-section through AA of Figure 16, this figure shows an alternative view of seal 1101, illustrating the varying thicknesses of several components of the seal. Specifically, the inlet perimeter 1110 and nose locators 1106 and 1108 are thicker in cross-section compared to the outer perimeter 1111. At least in the lateral direction, the thickened region 1110 near the inlet extends at least half the distance from the inlet to the outer perimeter edge 1121. In the upward direction, the thickened region extends at least half the distance from the inlet to the top perimeter edge 1123. In the downward direction, the thickened region extends at least half the distance to a lower portion 1125. These regions of the seal between nose locators 1106 and 1107 (generally indicated as 1112) are also thinner in cross-section, thus providing additional stability for these nose locators in these regions.

Figure 21 shows an alternative embodiment of the seal. In this alternative embodiment, the areas between the nose locators (denoted as 1113) are significantly thinner in cross-section compared to the area around the air inlet 1110 and the nose locators 1106 and 1108. This configuration can provide additional flexibility between the nose locators 1106 and 1108.

Figure 22 shows yet another embodiment of the seal of the present invention. Here, the seal is inflatable, but in use, it extends downwards to close the user's mouth. The seal 1200 has a plurality of nose positioning elements 1201 and 1202 and is received in a frame, similar to any of the embodiments described in the above description. The seal 1200 has an extension 1203 that extends beyond the user's mouth to create a seal and reduce mouth leakage.

Figure 23 shows another embodiment of the seal of the present invention. This seal 1300 has the same shape as that in Figure 22, with nose positioning elements 1301 and 1302 and a mouth covering extension 1203, but includes an outlet 1304 pointing to the user's mouth, which allows gas to be delivered simultaneously to the user's mouth and to the user's nasal passages through the nose positioning elements 1301 and 1302.

Figures 24 to 29 show the different header stripes that can be used with any implementation of the interface described herein.

Figure 24 shows a single head strip 1402, which is attached to the interface 1400 by any suitable means known in the field of interfaces and head strips, specifically to a flexible and inflatable seal 1401. The strip 1402 can be a hollow tube 1402 (as shown in Figure 24a) or a solid tube 1402' (as shown in Figure 24b). The hollow tube can be, for example, an extended silicone tube having a diameter between 3 mm and 6 mm and a wall thickness between 0.2 mm and 1 mm.

Figure 25 shows a single headband 1410, which is attached to the interface 1400 by any suitable means known in the field of interfaces and headbands, specifically to a flexible and inflatable seal 1401. The band 1410 can be a hollow extension tube 1410 (as shown in Figure 25a) or a solid extension tube 1410' (as shown in Figure 25b). In use, the band is preferably thinner at its ends 1411 and 1412 attached to the seal 1401 and thicker at the midpoint behind the user's head.

Figure 26 shows a double-headed strip 1420 attached to the interface 1400. The strip 1420 extends around the user's ear and has two attachment points on each side of the seal 1401 at which the strip is attached to the seal 1401.

Figures 27 and 27a show an extendable headband 1430 attached to interface 1400. The headband 1430 has a region 1431 that is stretched and contracted to better fit the headband to the user's head.

Figure 28 shows an alternative head strip 1440 attached to the interface 1400, specifically to the seal 1401. The head strip 1440 preferably includes a plurality of side strips 1441 having rigid regions 1442, 1443 for providing additional stability to the side strips 1441. The head strip 1440 also preferably includes a top strip 1444 and a rear strip 1445, the rear strip correspondingly extending over or behind the head. Further details of this head strip are found in Fisher and Paykel Healthcare U.S. Patent Application No. 12/307993, the contents of which are incorporated herein by reference.

Figures 29 and 29a show another alternative head strip 1450 attached to the interface 1400, specifically to the seal 1401. The head strip 1450 is curved and has multiple dividers 1451 that provide additional support or rigidity to the strip.

The headband detailed above can be formed from any suitable material, such as flexible plastic, silicone, laminated fabric, or other suitable material.

Figures 30 to 33 illustrate different methods in which an interface frame can be attached to an inflatable seal body. In Figure 30, the seal body 1500 includes overmolded or integrated rigid plastic barbs 1502. These barbs 1502 engage with correspondingly shaped recesses 1503 formed in the frame 1501 and maintain the seal body 1500 in a sealing engagement with the frame 1501.

Similarly, in Figure 31, the seal body 1500 has a periphery 1502 formed by an overmolded or bonded rigid plastic annular snap fastener 1503 that clips onto the frame 1501. Further details of this clamping mechanism are described in Fisher and Paykel Healthcare’s U.S. Patent Application No. 12/502528, the contents of which are incorporated herein by reference.

Alternatively, as shown in FIG32, the seal body 1500 may have an air inlet 1502 having a stretch interference fit adapted to fit around the frame 1501. The frame preferably has a recess 1503 and a raised edge 1504 that allows the air inlet 1502 to engage with the frame.

In an alternative form as shown in Figure 33, a sealing body 1500 can be permanently attached to the frame 1501 by overmolding or bonding.

Figures 34 to 40 illustrate different methods in which the tube (1112, see Figure 13) extending from interface 1100 can be secured to the user. The advantage of securing this tube to the user is that it removes the weight of the tube from the interface, reducing the likelihood of the interface being pulled off the user's face. Each strap described below is preferably made of a fabric strip. Preferably, the fabric is a breathable material, but other suitable fabrics can be used. In all the forms detailed herein, the tube is secured to the strap by a snap or pin.

Figure 34 shows a strap 1600, which is made of a loop strip of fabric and is placed around the user's head and one shoulder when in use.

Figure 35 shows an alternative strap 1610. This strap is also preferably made of fabric that is formed in a way that crosses the center of the user's chest and is attached around each of the user's arms.

Figure 36 shows an alternative strap 1620. Here, the strap 1620 has a central crossover of a strip that crosses the user's chest, but it is connected across the user's neck and back.

Alternatively, as shown in Figure 37, when a strap is formed of an annular strip (which wraps around the user’s chest and extends under their arms), strap 1630 can be used to secure the tube to the user.

As shown in Figure 38 or 39, the strap 1640 may additionally include two armbands 1641, 1642 or simply one armband 1643.

Alternatively, as shown in Figure 40, a simple strip 1650 can be used with the interface of the present invention, which simply adapts to the user's shoulder or upper arm when in use.

Referring to Figures 41-57 will illustrate additional tube support arrangements. Figures 41-51 illustrate a support collar intended to be worn around the user's neck, with the tube supported thereon by a tether. Figures 52-55 illustrate various aspects of the tether, which can be used with such a collar or with other arrangements for securing one end of the tether to the patient. Figures 56 and 57 show two such arrangements for securing a tether to a patient. Figures 34-40 show other arrangements for securing such a tether to a patient.

Figures 41 to 45, related to Figures 1 to 3, further illustrate the collar in the broad sense described above. The collar includes an adjustable connection 327 and a second connection 329. The adjustable connection operates between a first end 4100 and a second end 4102 of the collar. The adjustable connection 327 allows the user to set the amount of overlap between the ends 4100 and 4102 to be set. Figures 41 to 45 illustrate one form of the adjustable connection 327 in the form of a dome fastener system. A fastener portion 4104 is secured to the first strip end 4100. A plurality of complementary fastener portions 4106 are provided spaced apart along the second strip end 4102. Engaging the fastener 4104 with one of these fastener portions 4106 sets the overlap of the end 4100 relative to the end 4102. These fastener portions 4106 can be spaced apart at intervals between 2 cm and 5 cm, preferably between 3 cm and 4 cm. The circumference of the collar is given by increments between 3cm and 4cm.

Preferably, the outer overlapping end 4100 includes a single connector portion and the inner strip end includes a series of outward-facing second connector portions. With this arrangement, no connector portions face the patient's neck. Therefore, the inner surface of the neck collar has no scattered protrusions.

These connector parts can be, for example, multiple parts of a known type of arch fastener.

The very end of the inner end 4102 may include an outwardly projecting loop that engages with the overlapping portion of the collar strap. When the collar is set to a tighter size, this loop 4302 (shown only in Figure 43) aligns the free end of the non-overlapping end 4102 with the overlapping portion of the collar.

Alternative connectors for adjustable connections are shown in Figures 46 to 49. The dome fastener connection is shown in more detail in Figure 46.

An alternative fastener using engaging magnets is shown in Figure 47. The outer strip end 4702 includes an inward-facing magnet portion 4704. The inner strip end 4706 includes an outward-facing magnet portion 4708. The inward-facing magnet portion 4704 is preferably magnetically attracted to a first inward-facing polarity. The outward-facing magnet portion 4708 is preferably magnetically attracted with a complementary outward-facing polarity. A series of outward-facing magnets 4708 are spaced along the outer surface of the inner strip portion 4706.

These magnets can be attached to a base portion 4710, which in turn can be attached to the strip. For example, the magnets can be glued to a base material that can be sewn onto the strip. Alternatively, the magnets can be molded to include multiple holes to allow the magnets to be sewn directly onto the strip.

Magnet 4704 can be replaced with a magnetic material that can be attached to magnet 4708, but it is not a magnet itself. Alternatively, magnet 4708 can be replaced with multiple parts of a material that is magnetic but is not a magnet itself. For example, these magnets could be ferrite or rare earth elements, while the magnetic material could be small profiles of steel. Ferrite powder combined with a flexible polymer allows these magnets to be flexible while maintaining sufficient strength to secure the collar.

Figure 48 illustrates that the adjustable connection is made using a hook-and-loop fastener system. For example, the outer end portion 4802 may include a short section 4804 made of a material having multiple protruding hooks. The inner strip end 4806 may include an outward-facing section 4808 covered with multiple loops to which the hooks can engage and disengage. Suitable hook-and-loop fastener materials are sold under the trademark Velcro.

The outward-facing ring material can be sewn onto the collar strap, or the collar strap can be formed of a material that integrally includes these rings. The length of the ring portion 4808 is much larger than the length of the hook portion 4804, and preferably extends equivalent to a length that needs to be adjusted and is available on the collar. For example, the ring fastener material would have a length of approximately 15 cm along the collar strap.

Figure 49 illustrates an alternative mechanical fastener similar to the dome fastener. This type of dome fastener includes a smaller receiving aperture 4902 located on the concave portion and a smaller protruding pin 4904 located on the convex portion.

Referring back to Figures 43 to 45, the collar preferably includes a second releasable connection 329 between a third end 4302 and a fourth end 4304. Thus, the entire loop of the collar is divided into two separate strip segments. Each strip segment includes a portion of the adjustable connection 327 at one end and a portion of the second connection 329 at the other end.

Preferably, the second connection is non-adjustable. The second connection 329 is intended to engage and disengage each time the collar is used. The adjustable connection can be adjusted to the correct length and setting, and the second connection 329 can be used to secure and release the collar.

The second connection 329 can be formed by any suitable means, including the examples shown in Figures 46 to 49, or include a conventional releasable fastener as shown in Figures 50A and 50B (50A in the connected state and 50B in the open state), or a split connector that releases when tension within a predetermined range is applied.

The connection 329 shown in Figure 45 includes a detachable connector having a first body portion 4502 fixed to a strip end 4302 and a second body portion 4504 fixed to a fourth strip end 4304. Each of the first and second body portions includes a protruding tab and a socket. The protruding tab of one body and the socket of the other body are complementary. The protruding tab and the socket preferably have an interference fit. The amount of interference and the force required to pull the tab out of the socket define the release force for the detachable snap-fit.

This preferred split snap fastener is shown in more detail in Figures 51A and 51B. In Figure 51A, the snap fastener is shown in an open configuration, with a tab 5102 protruding from each snap fastener body portion, and each tab 5102 including a small lateral protrusion 5104. The insertion port in each body portion of the snap fastener includes a lateral aperture 5106. When the tab 5102 is pushed into the insertion port, the protrusion 5104 extends into the aperture 5106. This interference fit is provided by engaging the protrusion 5104 into the aperture 5106. Referring again to Figures 41-45, a tethering member extends from the collar. The tethering member 4112 is connected to the collar at one end and has an engaging snap 4114 connected at its free end. The engaging snap 4114 is used to connect to the supply catheter of the patient interface. The engagement snap 4114 is shown in more detail in Figure 55, which shows an enlarged view of its fitting with the cuff of the catheter. The preferred connector includes an open ring that fits onto a cannula portion of the cuff and is held in place between a flange 5502 of the cuff and a flange 5504 of the rotating catheter attached to the cuff.

The preferred fastening element includes a detachable snap-fit located at a position along its length between the connection on the neck collar and the catheter connector. This detachable connector can have the form already illustrated with reference to Figures 51A and 51B. Such a form of detachable connector is shown in Figures 52, 54A, and 54B.

Alternatively, the detachable connector may also include a swivel, so that the collar does not need to be correctly oriented relative to the catheter before the patient interface is worn. In this case, the detachable connector may include a socket portion 5302 and a convex portion 5304, wherein the convex portion 5304 is rotationally symmetrical. For example, the convex portion 5304 may include a protruding ball handle 5306 with an enlarged end 5308. The socket 5302 may include a plurality of protrusions or a ring-shaped protrusion around the inner circumference adjacent to the open end. The socket 5302 may need to be manufactured in two pieces and then secured together to create one or more protruding lips. The socket portion 5302 may be open at its other end 5310, so that the connector portion 5302 can be formed in a single piece. This end may receive one end of the strap portion 5312 of the tether.

Alternatively, a swivel may be included at another location along the tether.

Preferably, the tethering element is formed at one end together with a sliding connector 5202 for attachment to the collar. The sliding connector 5202 preferably includes a shaped ring on either side of the web of the collar and connected by transverse sections to straight sections above and below the edge of the collar. The ring preferably has a moderately tight fit on the collar, such that once moved into a position, it tends to remain in that position, but can move along the collar when sufficient force is applied. The ring 5202 substantially reflects the contour of the web of the collar. A tethering element portion may extend from the ring 5202, preferably integrally formed with the ring 5202. Preferably, the tethering element portion and the ring are formed of a flexible, elastic material (such as silicone).

Another fastening component extends from the quick-release connector into a conduit within the engagement latch. Furthermore, this can be formed of any suitable material, preferably a flexible material, and most preferably a silicone material.

The tether can have a fixed or adjustable length. Preferably, the tether can be provided in a variety of lengths (for selection based on the patient). The tether can have a length between 3 cm and 15 cm. A tether of approximately 3 cm is shown in Figures 54A and 54B, which includes a limited (if any) strip portion. The tether is primarily constructed via a ring connector on its neck collar, a quick-release connector, and its connection to the catheter connector.

The longer tethering element is shown in Figures 52 and 53, comprising a substantial strip portion between the connecting ring 5202 and the quick-release connector, and another substantial strip portion between the quick-release connector and the catheter connector. These portions of the tethering element are interchangeable, such that, for example, the strip portion of the tethering element can be provided intact to one side or the other side of the split connector.

Figure 56 illustrates an alternative support arrangement for using a neck collar. The tether 5602 terminates in a clip 5604 instead of at a connector for the neck collar. The clip 5604 (preferably in the form of a stud, alligator clip, or other arrangement with claws) is intended for attachment to the collar or other convenient part of the patient's clothing. Alternatively, the tether may terminate at a connector for connection to a strap structure to be worn by the patient, as previously described.

The fastening element may or may not include a detachable connector.

Figure 57 shows another alternative for attaching to the garment 5702 worn by the patient. This shows a push clip 5704 attached to the neckline of the garment and includes a detachable connector 5706.

The preferred neck collar is made of a material that is comfortable for the wearer. In its simplest form, the neck collar can be, for example, a strip made of a soft, flexible material that has sufficient stiffness to maintain the overall shape of the collar, sufficient strength to resist any substantial elongation or stretching, and whose inner surface facing the patient is comfortable. A suitable material could be, for example, a laminated foam material, such as Breathoprene, which has a foam mesh wrapped with knitted fabric on either side.

However, compared to Breathophprene, the preferred neckband is more resistant to stretching and more breathable. For comfort against the skin, the neckband is preferably covered with a woven, knitted, or braided natural fiber fabric. For example, a braided or knitted tube made of cotton or bamboo yarn. The braided or knitted tube surrounds a flexible skeleton, thereby giving the neckband its shape. The flexible skeleton may include a series of articulated frames or a shaped flexible strip formed by an open frame structure. Preferably, it comprises a narrow strip made of plastic mesh. An example of a suitable mesh is 3MESH manufactured by the Mullter Texti Group in Germany. This open frame structure or mesh form allows moisture and heat to easily pass through the neckband, thereby reducing discomfort for patients wearing the neckband for extended periods.

The collar strap is preferably 3cm to 6cm wide and between 3mm and 8mm thick.

Figures 1 to 3 illustrate a preferred, simple headband. It comprises a single, unbranched band terminating at either end with a connector. The band can be permanently attached to either end of the frame, but preferably these connectors are configured to be removable from the body of the mask.

The single, unbranched strip preferably adapts to substantial changes in head size without adjustment. The preferred strip has very low stiffness; a perfect 400mm strip requires no more than 4N of force to stretch from a fully unfolded but unstretched state to 1.3 times its initial length, and preferably no more than 2N. Figure 62 is a graph illustrating the tensile properties of four sample strip materials. Preferred materials include a braided nylon yarn incorporating multiple strands of Lycra. This nylon yarn is loosely formed enough to stretch beyond the required range without becoming tight. The amount of Lycra strands in the yarn can be varied, thus altering the strip's stiffness. The total diameter of the strip is preferably less than 10mm and most preferably less than 6mm.

The end connectors of the strip can be secured to the strip in any suitable manner. Preferably, these end connectors are overmolded onto the ends of the strip. Test results for a range of alternative strip materials are shown in Figure 62. All test results are for tensile lengths of the test material from a “rest” length of approximately 400 mm.

Line 6202 shows the tensile test results of a braided yarn made of nylon-bonded Lycra filaments, with a braided tube having a nominal diameter of 5 mm. This is also stiffer than expected.

Line 6206 shows a hypothetical, ideal response curve determined by the inventors.

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

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

Both silicone stretching methods exhibited satisfactory properties.

Line 6205 demonstrates the response curve of a preferred braided nylon yarn incorporating Lycra filaments. The braided tube has a nominal diameter of 4 mm.

Line 6208 demonstrates the response curve of a woven elastic band with a length of 3 mm. This product exhibits characteristics similar to preferred woven yarns; however, the elastic band tends to entangle hair and lose its elasticity.

Figures 58 to 61 illustrate another patient interface that incorporates a seal substantially as described above, but includes features that eliminate or reduce the need for additional catheter support. According to this embodiment, the mask body includes a suspension stabilizer 6102. A suspension stabilizer is provided on each side of the mask body. Each suspension stabilizer extends beyond the periphery of the mask seal and includes a foot 6104 for engaging against the wearer's upper lip. Preferably, the stabilizer does not extend beyond the inner surface of the seal, but is spaced forward from the inner surface of the seal, wherein the foot 6104 is positioned such that the mask, when worn on the patient and symmetrically positioned thereon, does not contact the wearer. Each foot 6104 may include a pad 6106 made of a soft material, such as a soft polymer or elastomeric foam or a segment of hollow silicone extrusion. These stabilizers can be engaged with the seal instead of the frame, for example, formed integrally as a molded silicone body that extends from near the central opening to protrude beyond the lower edge of the seal. In this case, these features on the mask body can fix the position of the fixed ends of these stabilizers.

Each stabilizer extends in a downward direction into a region below the seal and is intended to engage in the region of the patient's upper lip, defined by the mouth, nose, and nasolabial folds, and preferably not on the patient's cheek. Therefore, these legs are shaped and positioned to fit within this region. Each stabilizer 6102 and arm 6108 extends from the lateral central portion 6110 of the mask body. The shape and material of the arm can be such that the arm is rigid, or thus the arm has a desired degree of flexibility. Typically, the arm should be rigid.

When the interface is properly positioned and contacts the user's upper lip area, and when the interface swings to one side or the other relative to the user's nose (e.g., under the influence of the supply cannula), the stabilizers are intended to be positioned close to and spaced apart from the user's upper lip portion. Gentle pressure on the stabilizer's foot 6104 (which is laterally spaced from the centerline of the mask, preferably toward the distal edge of the mask) supports the mask against lateral forces from the cannula, preventing the mask from swinging too far across the face and damaging the seal.

In addition, these stabilizers are suspended below the mask and support it (if the weight of the tube tends to cause the mask to rotate forward). In this case, the feet 6104 of the two stabilizers will contact the user's upper lip and support the position of the mask.

These stabilizers are preferably shown in a form having a substantially rigid construction, but with a flexible pad or cushion 6106. However, to compensate for variations in patient geometry, this stabilizer can be an optional accessory, where different forms of stabilizers can be used to replace the mask connection arrangement. Alternatively, these stabilizers can be manufactured to be adjustable (e.g., by providing hinged portions that can have multiple fixed positions along the length of the stabilizer or at the joints of these arms and legs, or both). Alternatively, these arms can be formed of a stretchable material that is substantially yielding. Accordingly, these arms can be bent into a desired portion and held in that position by yielding the material.

In embodiments with articulated arms or legs, a connection arrangement may be provided to connect the movement of each stabilizer, or the stabilizers may be individually or collectively supported in place by one or more springs or other resilient components.

With the addition of these stabilizers, the mask can be effectively secured and placed on the patient without requiring additional support for the catheter. This, in turn, allows for a shorter length of the flexible connecting tube 6120. Therefore, the length of the flexible connecting tube 6210 (which should typically be much more flexible than the main supply catheter) can be reduced to between 5 cm and 15 cm, preferably about 10 cm. In systems including a humidifying gas supply device and a heated main supply catheter, this short flexible connecting tube is typically unheated. When the connecting tube requires support by a tether or collar, it has a minimum length typically exceeding 15 cm. Eliminating the requirement for a tether in a collar allows for a shorter connecting tube solely for flexibility, thus separating the relatively rigid supply catheter from the mask and facilitating free movement of the wearer's head. Because the connecting tube is typically unheated, moisture from the gas carried within it can drip onto the cooler wall surface, creating water accumulation that may eventually be blown into the user's nostrils, causing discomfort. If the lip stabilizer allows, a shorter tube is provided, thereby reducing the possibility of dripping in the conduit.

Claims (42)

1. An assembly for a patient interface (101), the assembly comprising: A nasal seal (301) includes a side that contacts the face. The seal (301) is formed of a soft, flexible material and includes a central portion (407) extending across the base of the nose, and a side portion (411) extending from each end of the central portion (407), each side portion (411) extending across a side of the nose. The face-contacting side of the seal (301) is soft to conform to the surface of the wearer's nose under internal pressure, including the outer surface of the side portion (411) of the seal (301) conforming to the side of the nose, such that the patient interface (101) is adapted to the nostril and has said side portion (411) curved around either side of the nose. An outer side of a seal (301) includes regions that are much harder than the softer inner sides, extending into multiple side portions (411) of the seal (301). The seal (301) includes an extension (1203) that extends beyond the user's mouth. A mask body (303) assembled to a seal (301), the mask body (303) being formed of a material harder than the seal (301), and together with the seal (301) forming a housing having an air inlet and a patient exhaust opening, and The outer side of the seal includes an opening (403). The mask body (303) is curved to approximately conform to the contour of the wearer's upper lip, and the seal (301) is formed such that the opening (403) of the seal (301) conforms to this approximately curved shape in a plane. The seal (301) curves around the wearer's nose bridge area but does not extend beyond the wearer's nose bridge area. Above the opening (403), the central portion (407) includes an outward-facing wall (431), an inward-facing wall (433), and a peripheral portion (435), wherein at least the inward-facing wall (433) and the outward-facing wall (431) are thin and flexible. 2. The combination as claimed in claim 1, wherein the seal (301) is inflatable. 3. The combination as claimed in claim 1, wherein the extension (1203) includes an outlet (1304) pointing toward the user's mouth. 4. The combination as claimed in claim 1, wherein the seal (301) is permanently attached to the mask body (303). 5. The combination of claim 4, wherein the seal (301) is attached by overmolding or bonding. 6. The combination of any one of claims 1 to 5, wherein the seal (301) comprises an overmolded or integrated rigid plastic barb (1502) that engages in a correspondingly shaped recess (1503) formed in the mask body (303) and holds the seal (301) in a sealing engagement with the mask body (303). 7. The combination of any one of claims 1 to 5, wherein the seal (301) has a periphery (1502) formed by an overmolded or bonded rigid plastic annular snap (1503) and clipped onto the mask body (303). 8. The combination of any one of claims 1 to 5, wherein the mask body (303) includes a nose seal engagement portion to engage the outer side of the seal (301). 9. The combination of any one of claims 1 to 5, wherein the mask body (303) includes a sealing opening (501) for engaging with the opening (403) of the seal (301). 10. The combination as claimed in claim 9, wherein the opening (403) of the seal (301) is on an outward-facing wall of the central portion (407) of the seal (301). 11. The combination of claim 10, wherein the opening (403) of the seal (301) includes a feature that engages with a complementary feature of the mask body (303). 12. The combination as claimed in claim 11, wherein the opening (403) of the seal (301) is characterized as a lip and/or channel, and the complementary feature of the mask body (303) is a channel and/or lip. 13. The combination of any one of claims 1 to 5, wherein the region much harder than the soft inner side comprises a flexible insert made of a reinforcing or rigid material. 14. The combination of claim 13, wherein the insert made of the rigid material is integrated into the mask body (303). 15. The combination of any one of claims 1 to 5, wherein the opening (403) of the seal (301) is the same size as the extent of the mask body (303), which is the same size as the total width of the combination and approximately the same size as the nose width of the intended wearer. 16. The combination of any one of claims 1 to 5, wherein the area of the seal (301) adjacent to and including the opening (403) is much harder than the rest of the seal (301). 17. The combination of any one of claims 1 to 5, wherein the area of the seal (301) adjacent to and including the opening (403) is formed thicker of the same material as the remainder of the seal (301). 18. The combination of any one of claims 1 to 5, wherein the area of the seal (301) adjacent to and including the opening (403) is formed of a material harder than the rest of the seal (301). 19. The combination of any one of claims 1 to 5, wherein the central portion (407) extends above and below the opening (403) of the seal (301), and the central portion (407) includes a thin and flexible region above and below the aforementioned opening (403). 20. The combination of any one of claims 1 to 5, wherein the peripheral portion (435) above the opening (403) is thin and flexible. 21. The combination of any one of claims 1 to 5, wherein below the opening (403) of the seal (301), the central portion (407) comprises an outer wall portion (441), an inner wall portion (443), and a peripheral portion (445), wherein at least the inner wall portion (443) and the peripheral portion (445) are thin and flexible. 22. The combination of any one of claims 1 to 5, wherein each side portion (411) includes an outward face portion (413) and an inward face portion (415) and a peripheral edge portion (417) connecting the inward face portion (415) and the outward face portion (413). 23. The combination of claim 22, wherein the peripheral edge portion (417) of the seal (301) allows the mask body (303) to be displaced relative to the axis of the patient’s face in the lateral and vertical directions. 24. The combination of any one of claims 1 to 5, wherein the mask body (303) includes at least one strip engagement portion to engage an annular strip to secure the patient interface to the patient. 25. The combination of claim 24, wherein the central portion of the mask body (303) defines a convexity that generally mates with the convexity of the outer-facing wall of the seal (301), wherein a strip engagement portion extends from the lateral end of the central portion at an angle outwardly aligned with the generally convexity relative to the central portion. 26. The combination of claim 24, comprising at least two strip joint portions, each strip joint portion extending laterally away from the air intake opening from opposite sides of the air intake opening. 27. The combination of claim 24, wherein the strip joint portions deviate from the outer wall of the seal at an angle greater than 30° between each strip joint portion and the outer wall. 28. The combination as claimed in claim 24, wherein the strip joint portion extends beyond the widest outer extent (741) of the seal (301). 29. The combination as claimed in claim 28, wherein the distance (721) from the widest outer extent (741) of the strip joint portion to the tip (717) of the strip joint portion is between 10 mm and 35 mm. 30. The combination of any one of claims 1 to 5, wherein the mask body (303) includes a port (305) for connecting an air supply conduit. 31. The combination of any one of claims 1 to 5, wherein the mask body (303) is made of a plastic material. 32. The combination of claim 31, wherein the mask body (303) is made of polycarbonate or silicone. 33. The combination of any one of claims 1 to 5, wherein the mask body (303) includes a gas flushing outlet with an opening. 34. The combination of any one of claims 1 to 5, wherein the region much harder than the soft inner side and the soft inner side comprise silicone and/or rubber materials. 35. The combination of any one of claims 1 to 5, wherein the region much harder than the soft inner side and the soft inner side are made of the same material. 36. The combination of any one of claims 1 to 5, wherein the region much harder than the soft inner side is formed thicker of the same material as the rest of the seal (301). 37. The combination of claim 36, wherein a region much harder than the soft inner side gradually reaches the thickness of the inner side. 38. The combination of any one of claims 1 to 5, wherein the opening (403) of the seal (301) is on an outwardly facing wall of the central portion (407) of the seal (301) and includes features that engage with complementary features of the mask body (303), and the mask body (303) includes an vent opening (501) of the seal for engaging with the opening (403) of the seal, the opening (403) of the seal (301) being characterized as a lip and/or channel, and the complementary features of the mask body (303) being a channel and/or lip, and wherein below the opening (403), the central portion (407) includes an outer wall portion (441), an inner wall portion (443), and a peripheral portion (445), wherein at least the inner wall portion (443) and the peripheral portion (445) are thin and flexible. 39. The combination of any one of claims 1 to 5, wherein the opening (403) of the seal (301) is on an outward-facing wall of the central portion (407) of the seal (301) and includes features that engage with complementary features of the mask body (303), and the mask body (303) includes an vent opening (501) of the seal for engaging with the opening (403) of the seal, the opening (403) of the seal (301) being characterized as a lip and/or channel, and the complementary features of the mask body (303) being a channel and/or lip, and a region much harder than the soft inner side being formed thicker by the same material as the rest of the seal (301) and gradually reaching the thickness of the inner side. 40. The combination of any one of claims 1 to 5, wherein the opening (403) of the seal (301) is on an outwardly facing wall of the central portion (407) of the seal (301), including features engaging complementary features of the mask body (303), and the mask body (303) includes an vent opening (501) of the seal for engaging the opening (403) of the seal, the opening (403) of the seal (301) being characterized as a lip and/or channel, and the mask... The complementary features of the body (303) are channels and/or lips, wherein below the opening (403), the central portion (407) includes an outer wall portion (441), an inner wall portion (443), and a peripheral portion (445), wherein at least the inner wall portion (443) and the peripheral portion (445) are thin and flexible, and wherein a region much harder than the flexible inner side is formed thicker by the same material as the rest of the seal (301) and gradually reaches the thickness of the inner side. 41. A patient interface comprising the combination of any one of claims 1 to 5, wherein a strip extends from the combination in a loop, one end of the strip originating from a first portion of the combination and the other end of the strip originating from a second portion of the combination. 42. The patient interface of claim 41, wherein the strip has a stiffness of less than 2 N per 100 mm extending from a relaxed state.