Patent Description:
Breathing gases can be delivered to users with a variety of different mask styles and can be delivered for a variety of different purposes. For example, users can be ventilated using non-invasive ventilation (NIV). In addition, continuous positive airway pressure (CPAP) or variable airway pressure can be delivered using masks to treat a medical disorder, such as obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

These non-invasive ventilation and pressure support therapies generally involve the placement of a user interface device, which is typically a nasal or nasal/oral mask, on the face of a user. The flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the user through the mask.

Typically, patient interface devices include a mask frame that supports a sealing member. The sealing member contacts the facial surfaces of the user, including regions surrounding the nose, including the nose and the nares. Because such masks are typically worn for an extended period of time, a variety of concerns must be taken into consideration. For example, in providing CPAP to treat OSA, the user normally wears the mask all night long while he or she sleeps. One concern in such a situation is that the mask should be as comfortable as possible. It is also important that the mask provide a sufficient seal against a user's face without significant discomfort.

<CIT> discloses an unobtrusive nasal mask for delivering breathable gas to a patient. <CIT> discloses a patient interface including a nasal seal having a face contacting side.

Accordingly, it is an object of certain embodiments of the present invention to provide an improved sealing member for use in a mask assembly that overcomes the shortcomings of conventional sealing members.

The present invention provides a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft flexible material and defining an inner cavity and one or more delivery openings for supply of breathing gases from the inner cavity to the patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an interior side and an exterior side, wherein the interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions is configured to extend across a side of the nose. The interior side of the seal body is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions of the seal body, to outside surfaces of the side of the nose. Each of the side portions defines a transition portion between the exterior side and the interior side, wherein the exterior side of each of the side portions comprises stiffened regions that are stiffer or much stiffer than the supple interior side, the stiffened regions extending to or substantially to the transition portions. The lower, rearward corners of the side portions comprise outwardly-protruding corners that flare outwardly relative to adjacent portions of the side portions. The stiffened regions extend at least partially into the outwardly-protruding corners.

In some such configurations, the stiffened regions are formed by relatively thickened portions of the seal body. The thickened portions can taper in thickness before the transition portions. The transition portions can include a portion that is thicker than the supple interior side.

In some such configurations, the stiffened regions extend substantially along an entire length of the exterior side of the seal body.

In some such configurations, the transition portions comprise rounded wall sections.

In some such configurations, a support is formed of a relatively rigid material and supports a portion of the seal body. The support can define at least one grip surface portion extending along the exterior side of the seal body. The at least one grip surface portion can comprise at least one pair of grip surface portions substantially opposite one another.

In some such configurations, the support defines a mount for mounting the nasal seal to the frame. The mount can comprise a first member that is connectable to a second member, wherein the first member and the second member capture a portion of the seal body between them. The first member can be positioned within a cavity of the seal body and can comprise a sleeve portion that extends outwardly from the cavity. The second member can surround the sleeve portion of the first member.

In some such configurations, the one or more delivery openings comprise a first delivery opening and a second delivery opening. The nasal seal can further comprise a nostril locator associated with and forming a portion of each delivery opening, wherein a deflection region is defined within an annular transition portion between each of the nostril locators and a surrounding portion of the interior side. The deflection region has a lower stiffness relative to another region of the annular transition portion not within the deflection region.

In some such configurations, the lower stiffness is achieved by the deflection regions having a smaller thickness than the other regions of the annular transition portion. The deflection regions can be located on the outer sides of the nostril locators. The deflection regions can be limited to less than or equal to one-half of the annular transition portion.

In some such configurations, the central portion of the seal body defines a thinned region that permits forward movement of an upper portion of the interior side of the central portion as a result of rolling movement of the seal body.

In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft flexible material and defining an inner cavity and one or more delivery openings for supply of breathing gases from the inner cavity to the patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an interior side and an exterior side, wherein the interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions is configured to extend across a side of the nose. The interior side of the seal is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions of the seal, to outside surfaces of the side of the nose. The exterior side of each of the side portions comprises stiffened regions that are stiffer or much stiffer than the supple interior side, the stiffened regions being disposed in a rearmost and lowermost sections of the side portions.

In some such configurations, the rearmost and lowermost sections of the side portions flare outwardly relative to adjacent portions of the seal body.

In some such configurations, the flared side portions are generally aligned with surfaces of the user's cheek or upper lip laterally outward of the nose.

In some such configurations, the stiffened regions are formed by relatively thickened portions of the seal body.

In some such configurations, the thickened portions taper in thickness before transition portions between the interior side and the exterior side.

In some such configurations, the transition portions include a portion that is thicker than the supple interior side.

In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft flexible material and defining an inner cavity and one or more delivery openings for supply of breathing gases from the inner cavity to the patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an interior side and an exterior side. The interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions is configured to extend across a side of the nose. The interior side of the seal is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions of the seal, to outside surfaces of the side of the nose. The exterior side of each of the side portions comprises stiffened regions that are stiffer or much stiffer than the supple interior side. The exterior side of the seal body further defines a grip surface on each of the side portions, the grip surfaces located on the stiffened regions.

In some such configurations, the grip surface is formed by a protrusion.

In some such configurations, the protrusion is generally crescent-shaped, thereby defining a generally scallop-shaped grip surface.

In some such configurations, the ends of the protrusion are positioned rearward of the center, curved portion of the protrusion.

In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft flexible material and defining an inner cavity and one or more delivery openings for supply of breathing gases from the inner cavity to the patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an interior side and an exterior side. The interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions is configured to extend across a side of the nose. The interior side of the seal is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions of the seal, to outside surfaces of the side of the nose. The nasal seal further comprises a support formed of a relatively rigid material and supporting a portion of the seal body. The support defines at least one grip surface portion extending along the exterior side of the seal body.

In some such configurations, the support defines at least one grip surface portion extending along the exterior side of the seal body.

In some such configurations, the at least one grip surface portion comprises at least one pair of grip surface portions substantially opposite one another.

In some such configurations, the support defines a mount for mounting the nasal seal to the frame.

In some such configurations, the mount comprises a first member that is connectable to a second member, wherein the first member and the second member capture a portion of the seal body between them.

In some such configurations, the first member is positioned within a cavity of the seal body and comprises a sleeve portion that extends outwardly from the cavity.

In some such configurations, the second member surrounds the sleeve portion of the first member.

In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft flexible material and defining an inner cavity. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an interior side and an exterior side. The interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions is configured to extend across a side of the nose. The interior side of the seal is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions of the seal, to outside surfaces of the side of the nose. The seal body comprises a first delivery opening and a second delivery opening for supply of breathing gases from the inner cavity to the nostrils of the user. A nostril locator is associated with and forms a portion of each delivery opening. A deflection region is defined within a transition portion between each of the nostril locators and a surrounding portion of the interior side. The deflection region has a lower stiffness relative to another region of the transition portion not within the deflection region.

In some configurations, the deflection regions have a lower thickness than the other region of the transition portion.

In some configurations, the deflection regions are located on an outer side of the nostril locators to facilitate movement of the nostril locators outwardly away from one another.

In some configurations, the deflection regions are limited to less than or equal to one-half of the transition portion, which can be generally annular in shape.

In some configurations, a patient interface or a seal arrangement for a patient interface comprises a first delivery opening and a second delivery opening for supply of breathing gases from the inner cavity to the nostrils of the user. A nostril locator or seal member (e.g., nasal pillow) is associated with and forms a portion of each delivery opening. A deflection region is defined within an annular transition portion between each of the nostril locators or seal members and a surrounding portion of the seal arrangement. The deflection region has a lower stiffness relative to another region of the transition portion not within the deflection region. The lower stiffness may be accomplished by a lower wall thickness within the deflection region compared to the other region. The deflection region may be located on the outsides of the nostril locators or seal members to facilitate outward tilting. The deflection region may be limited to less than or equal to about one-half of the annular transition portion, which can be generally annular in shape.

In some configurations, a sealing member is provided for a mask with the sealing member having any set or subset of features or any combination of sets or subsets of features described herein. In some such configurations, a mask can have such a sealing member.

In some configurations, a seal member comprises a proximal surface and a distal surface. The proximal surface has one or more delivery openings for supply of breathing gases to the patient. The proximal surface and the distal surface define an inner cavity within the seal member. At least one integrated support structure underlies at least a portion of the inner cavity.

In some such configurations, the at least one integrated support structure comprises a crescent shaped member that is structurally integrated into the seal member.

In some such configurations, the at least one integrated support structure extends at least partially upward along at least a portion of the distal surface. In some such configurations, the at least one integrated support structure extends upwardly along the distal surface. In some such configurations, a portion of the at least one integrated support structure that extends upwardly along the distal surface extends proximally and is configured to provide support relative to a region of a user along a cheek region.

In some such configurations, the portion of the integrated support structure that underlies the inner cavity extends proximally and is configured to provide support relative to a region of a user just above a lip.

In some such configurations, the integrated support structure comprises one or more thickened regions of the seal member. In some such configurations, the thickened regions incorporate a hollow region having another material positioned within hollow region of the integrated support structure.

In some such configurations, the at least one integrated support structure is positioned in a marginal surface that connects the proximal surface to the distal surface. In some such configurations, the marginal surface is wider at a bottom portion than at a top portion. In some such configurations, the seal member has a thicker wall in a region that includes the bottom portion of the marginal surface relative to a region generally surrounding the one or more delivery openings. In some such configurations, the region with the thicker wall extends upwardly from the bottom portion of the marginal surface.

In some such configurations, the at least one integrated support structure is positioned to be in a widest lateral region of the seal member.

In some such configurations, the at least one integrated support structure extends most proximally of any other portion of the seal member.

In some such configurations, the at least one integrated support structure is positioned to be in a widest lateral region of the seal member and extends most proximally of any other portion of the seal member.

Various features, aspects and advantages of the present invention can be implemented in any of a variety of manners. For example, while several embodiments will be described herein, sets or subsets of features from any of the embodiments can be used with sets or subsets of features from any of the other embodiments.

The term "comprising" is used in the specification and claims, means "consisting at least in part of". When interpreting a statement in this specification and claims that includes "comprising", features other than that or those prefaced by the term may also be present. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

These and other features, aspects and advantages of the present invention will be described with reference to the following drawings.

<FIG> illustrates a patient interface <NUM> that is arranged and configured in accordance with certain features, aspects and advantages of the present invention. The interface <NUM> can be used to supply pressurized breathing gases to a recipient. The interface <NUM> is well suited for providing breathing gases to the recipient in situations where significant pressure changes are likely to be encountered. For example but without limitation, the interface <NUM> can be used for delivering continuous positive airway pressure (CPAP).

With continued reference to <FIG>, the interface <NUM> is shown separate from a patient who would wear the interface <NUM>. Some aspects of the patient interface <NUM>, and variations on each aspect, have been described in <CIT>. The interface <NUM> broadly comprises a mask <NUM>. In some configurations, a strap <NUM> can attach to the mask <NUM> and can be used to secure the mask <NUM> to the patient. In some configurations, the interface <NUM> also comprises a flexible supply conduit <NUM> that can connect to the mask <NUM>.

With continued reference to <FIG> and with additional reference to <FIG>, the mask <NUM> is configured to fit over or overlie both nostrils of the patient. In some configurations, the mask <NUM> can include lateral portions <NUM> (see <FIG>) that are configured to curve around toward each lateral side of a nose of the patient. These lateral portions <NUM> can form a perimeter seal on outwardly facing surfaces of flanks of the nose. The strap <NUM> can pass around the user's head in a simple loop above the user's ears.

The flexible conduit <NUM> can depend from a central connection <NUM>. In some configurations, the central connection <NUM> can be positioned at a frontal portion of the mask <NUM>. The central connection <NUM> preferably comprises a swiveling elbow. The elbow can enable the flexible conduit <NUM> to pivot relative to the mask <NUM>. By enabling pivoting, the elbow can help the interface <NUM> to better adapt to the sleeping position of the patient. In some configurations, the central connection <NUM> may comprise a ball joint so that the elbow can pivot about axes parallel to and perpendicular to its connection with the mask <NUM>.

The illustrated mask <NUM> generally comprises a seal <NUM> and a body or frame <NUM>. The seal <NUM> and the frame <NUM> can be connected in any suitable manner.

The seal <NUM> preferably defines a supple pocket or envelope that can contain a recess region. In some configurations, the seal <NUM> can comprise a low wall thickness and can be formed of any suitable material. For example but without limitation, the seal <NUM> can be formed of latex, vinyl, silicone or polyurethane. In some configurations, the wall thickness can be below about <NUM> and could be lower than about <NUM> in some regions and in some configurations. In some configurations, the seal <NUM> can be formed of a material having sufficient elasticity and yield strength so that the combination renders the seal <NUM> supple. The seal <NUM> preferably is capable of withstanding repeated drastic deformations without failure.

With reference to <FIG>, the seal <NUM> preferably comprises one or two nostril locators <NUM>. The nostril locators <NUM> can protrude from the seal <NUM>. In some configurations, the nostril locators extend generally upwardly and rearwardly from a proximal wall <NUM> of the seal <NUM>. In some configurations, the nostril locators <NUM> extend generally rearwardly from the proximal wall <NUM> of the seal <NUM>.

In the configuration illustrated in <FIG>, the nostril locators <NUM> are formed integrally (i.e., in one monolithic piece) with the seal <NUM>. Each nostril locator <NUM> can comprise an outlet aperture <NUM> through which gas can be supplied from the flexible conduit <NUM>. In some configurations, the gas can be supplied from within the pocket or envelope defined by the seal <NUM>. In other configurations, the gas that is supplied can be separate from the gas supplied to the pocket or envelope defined by the seal <NUM>.

The seal <NUM> generally comprises a distal wall <NUM> and the proximal wall <NUM>. An outer surface of the distal wall <NUM> preferably faces away from the user while an outer surface of the proximal wall <NUM> preferably faces the user. A rim <NUM> (see <FIG> and <FIG>) can connect an outer perimeter of the distal wall <NUM> and an outer perimeter of the proximal wall <NUM>. The envelope or pocket described above can be defined within at least the distal wall <NUM> and the proximal wall <NUM>.

The seal <NUM> preferably is designed to wrap around the tip or lower portion (e.g., locations below the bridge) of the user's nose. As such, the illustrated seal <NUM> comprises a central portion <NUM> (see <FIG>) positioned between side portions or wings <NUM>. The central portion <NUM> can underlie the user's nose and preferably incorporates the nostril locators <NUM>. In some configurations, the central portion <NUM> can extend upward over a tip of the user's nose. In other configurations, the central portion <NUM> does not extend upward over the tip of the user's nose. The wings <NUM> can form at least a portion of the lateral portions <NUM> discussed above. The wings <NUM> can be configured to extend completely or substantially completely over the sides of the user's nose and may extend at least partially over the user's cheeks.

As described above, at least a substantial portion of the seal <NUM> can be supple. For example, a region surrounding the nostril locators <NUM> can be more supple than at least a portion of the wings <NUM>. At least the proximal wall <NUM> and the rim <NUM> of each side portion can be very supple so that they can expand to conform to the contours of the user's face, and in particular, to the contours of the outside flanks of the user's nose. Preferably, the supple portions of the seal <NUM> are of sufficient dimension and shape that, when the inflated seal is pressed against the face of the user with the nostril locators <NUM> engaged in the nostrils of the user, the seal <NUM> conforms to the surfaces of the user's face (i.e., at least the sides of the nose and along at least a portion of the upper lip).

Select portions of the seal <NUM>, however, can have an increased rigidity to improve the form, fit and function of the mask <NUM>. For example, at least a portion of the rim <NUM> can be significantly stiffer to provide control to ballooning of other regions of the seal <NUM>. In addition, a region adjacent to and including an inlet opening (e.g., the portion that receives the flow of gases from the conduit <NUM>) of the seal <NUM> can be less supple. Thus, the distal wall <NUM> can have a decreasing suppleness from the wings <NUM> to the central portion that contains the inlet opening. The less supple regions can be formed of a different material or can be formed of the same material but with an increased thickness.

As described above, the frame <NUM> supports the seal <NUM>. In some configurations, an inlet opening of the seal <NUM> can be fitted to the frame <NUM> and the flexible conduit <NUM> also can be fitted to the frame <NUM> such that gases can be provided to the seal <NUM> through the frame <NUM>. In other configurations, the seal <NUM> directly connects to the flexible conduit <NUM>. In some configurations, the seal <NUM> can be connected to the conduit <NUM> with the central connection <NUM>.

The frame <NUM> may have any suitable arrangement for securing the seal <NUM>. In some configurations, an annular wall can extend from a proximal side of the frame <NUM> around a perimeter of an opening that extends to the connector <NUM>. The annular wall can include an outwardly extending lip. The inlet opening of the seal <NUM> can engage over the outwardly extending lip of the annular wall. In some configurations, the inlet opening of the seal <NUM> can be stretched to fit over the annular wall. The inlet opening of the seal <NUM> may be provided with a thickened or reinforced wall section, for example but without limitation. In some configurations, an extended portion of the seal <NUM> can be rolled up over the annular wall of the frame <NUM>. In another configuration, the seal <NUM> can be provided with a portion of a connector and at least one of the frame <NUM> and the conduit <NUM> may include a complementary connector portion.

The frame <NUM> can be designed to be minimal in size. Advantageously, the small size of the frame <NUM> enables a clear field of vision for the user and allows the user to wear glasses while wearing the interface <NUM>. Preferably, the frame <NUM> is formed from an elastomeric material, which will allow the frame <NUM> to flex to conform slightly to the face of the user. The frame <NUM>, however, provides support for the seal <NUM>. By providing support for the seal <NUM>, the seal can be more effectively pressed into contact with the face and around the nose of the user. The frame <NUM> can be formed by injection molding, preferably from an elastomeric material, such as silicone or polyurethane, for example but without limitation. In some configurations, the frame <NUM> can be formed of more rigid materials, such as polycarbonate, polyester polystyrene, or nylon, for example but without limitation.

In use, the portions of the supple proximal wall <NUM> that are above, below and to each side of the nostril locators <NUM> can be inflated by pressure inside the seal <NUM> (e.g., inflated from the flow of gases supplied to the patient interface <NUM>) to press against the skin of the user and conform to contours of the outside surfaces of the nose of the user, to surfaces of the lower portion of the nose of the user and to surfaces of the upper lip of the user immediately below the nose. Movement of the mask <NUM> is not likely to significantly break this seal with the face because the supple perimeter or periphery of the seal <NUM> allows the mask <NUM> to move in all directions (other than directly away from the face) to at least a small extent. The supple portions of the seal <NUM> somewhat decouple the position of the nostril locators <NUM> from the position of the mask <NUM>, which decoupling allows the mask <NUM> to displace somewhat in at least one or both of the lateral and vertical directions (i.e., lateral and vertical relative to axes of the patient's face). The wings <NUM> engage the sides of the user's nose and form an additional seal. The wings <NUM> also support the location of the mask.

With reference to <FIG>, when donning the interface <NUM>, the mask <NUM> can be opened by spreading the wings <NUM> apart, which increases the angle between the wings <NUM>. With the wings <NUM> having been pulled open, the nostril locators <NUM> (see <FIG>) that are positioned on the proximal wall <NUM> better present toward the user and guide the location of the mask <NUM> onto the face of the user. With the nostril locators <NUM> properly positioned, the mask <NUM> can be secured in position with the strap <NUM>, which forms a loop around the head of the user at a location vertically higher than the ears. Other techniques for donning the interface also can be used.

As described above, when donning the interface <NUM>, the seal <NUM> preferably is folded or spread open in order to improve fit and to help achieve a desired positioning. In the configuration of <FIG>, however, spreading open the seal <NUM> generally requires that fingers be positioned between the seal <NUM> and the face of the user, which can be awkward for users. In addition, it can be difficult to open the seal <NUM> with a single hand such that the other hand can be used to bring the strap <NUM> into position.

With reference to <FIG>, an interface 100a is shown with a seal manipulation assembly <NUM>. For clarity, a seal 114a of the interface 100a is shown enlarged and without a frame 116a in the lower portion of <FIG> and connected to the frame 116a in the upper portion of <FIG>. The seal manipulation assembly <NUM> preferably comprises a pair of pads <NUM>. The pads <NUM> extend outward from the seal 114a. In some configurations, the pads <NUM> are positioned along the distal surface 122a. In some configurations, the pads <NUM> extend outward from the distal surface 122a. In some configurations, the pads <NUM> are integrally formed with the seal 114a. In some configurations, the pads <NUM> are separate components from the seal 114a. In the illustrated configuration, a frame 116a of the interface 100a comprises recesses <NUM> that receive at least a portion of the pads <NUM>. The seal 114a underlies the frame 116a in the region of the pads <NUM>. In some configurations, the seal 114a is not secured to the frame 116a in the region of the pads <NUM> or proximal of that region such that the seal 114a can be moved relative to the frame 116a.

The pads <NUM> are connected to an operating mechanism of the seal manipulation assembly <NUM>. In some configurations, the pads <NUM> are connected to scissor arms that extend within the seal 114a. The scissor arms can cross and be connected with a hinge such that squeezing of the pads <NUM> toward each other can result in the ends <NUM> of the seal 114a moving apart from each other.

In some configurations, the operating mechanism is simpler than the scissor mechanism described directly above. For example, with reference to <FIG>, which is a simplified representation of an operating mechanism, the pads <NUM> connect to, or are integrally formed with, arms <NUM>. The arms can extend toward the ends <NUM> of the seal 114a. The arms <NUM> can have a length that is longer than the length of the pads <NUM>. A forward portion of the arms <NUM> can be held apart from each other using a cross member <NUM>. In some configurations, the material of the seal 114a, the frame 116a or the seal 114a and the frame 116a combined may be stiff enough to allow separation or spreading of the ends <NUM> of the seal 114a through manipulation of the pads <NUM> without including the cross member <NUM>. By holding the arms <NUM> apart at a location between the pads <NUM> and the ends <NUM>, depressing the pads <NUM> toward each other will result in the ends <NUM> moving apart from each other. In some configurations, the arms <NUM> can be joined together by a living hinge, by a rigid connection to a flexible cross member that elastically deforms or by a pin joint or the like.

By manipulating the shape of the uninflated seal 114a (e.g., by separating the ends 146a to alter how the seal 114a initially presents itself to the user), the seal 114a is opened for placement onto the face of the user. Once in place, the seal 114a can be inflated, which causes the seal 114a to swell around the nares of the user.

With reference now to <FIG>, another seal 114b is illustrated. The seal 114b has been provided with another seal manipulation configuration 140b. In the illustrated seal 114b, the seal manipulation configuration 140b can be attached to or integrally formed with a portion of the distal wall 122b. Preferably, the seal manipulation configuration 140b is positioned along the distal wall 122b along the lateral portions 110b or wings 130b.

The seal manipulation configuration 140b can take any suitable configuration. In some configurations, for example but without limitation, the seal manipulation configuration 140b comprises walls <NUM> that can define loops of material into which fingers can be inserted. In the illustrated configuration, the seal manipulation configuration 140b comprises pockets <NUM>. Each of the pockets <NUM> can have a rim <NUM> at the distal end. The rim <NUM> can define an opening sufficiently large to receive a finger tip. The proximal end of each of the pockets <NUM> can be enclosed or open. In the illustrated configuration, the proximal end of each of the pockets <NUM> is enclosed.

In some configurations, a surface feature <NUM> can be provided adjacent to the opening defined by the rim <NUM>. The surface feature <NUM> can be a recess or a surface texture. The surface feature <NUM> can be positioned just forward of the opening to guide fingers into a desired location. The surface feature <NUM> can provide additional clearance to facilitate insertion of the fingers.

By positioning the pockets <NUM> on the outside of the seal 114b, fingers can be inserted into the pockets <NUM> and the pockets <NUM> can be used to provide an outward force on the wings 130b to open the seal 114b for presentation to the face.

With reference now to <FIG>, a mask 102c can have a seal 114c that features integrated arms <NUM>. In the illustrated configuration, the arms <NUM> can extend along an outer portion of the distal wall 122c. With the arms <NUM> integrated into the seal 114c, the frame <NUM> can be omitted, integrated directly into the seal 114c or remain a separate supporting element. When integrated into the seal 114c, the mask frame <NUM> can be defined by a region of increased stiffness (i.e., a region of less suppleness). For example, when integrated into the seal 114c, the mask frame <NUM> features can be replaced with regions of increased thickness or overmolded characteristics.

In the illustrated configurations, the integrated arms <NUM> extend proximally from a distal region of the distal wall 122c. Preferably, each end 146c is separated from the associated arm <NUM> such that the ends 146c can move without significant movement of the overlying portion of the arms <NUM>. In other words, the connection between the arms <NUM> and the distal wall 122c can terminate distally of the end 146c such that at least a portion of the arm <NUM> overlies, but is not directly connected to, the proximal end of the distal facing wall 122c.

In the illustrated configuration, an attachment member <NUM> can be formed at the proximal end of each arm <NUM>. The attachment member <NUM> can have any suitable configuration and can be used to connect the arms <NUM> to a strap (not shown) or other headgear assemblies. In the illustrated configuration, the attachment member <NUM> comprises a post <NUM> that is positioned within a recess <NUM>. The strap or other headgear can be passed around the post <NUM> or secured with a hook member to the post <NUM> for example but without limitation.

<FIG> illustrate seals 114d having differing surface textures along at least a portion of the proximal wall 124d. The surface textures can be positioned along any portion of at least the proximal wall 124d. In some configurations, the surface textures can be positioned along a proximal portion of the proximal wall 124d. In some configurations, the surface textures are only positioned along a proximal portion of the proximal wall. In some configurations, the surface textures can be positioned on other surfaces but, with respect to the proximal wall 124d, the surface textures are only positioned proximally of any nostril locators 120d.

<FIG> illustrated the following surface textures: slots <NUM>; recesses <NUM>; scallops <NUM>; plateaus <NUM>; and ribs <NUM>. Any other suitable surface textures, including shapes, recesses and protrusions, can be provided to the proximal wall 124d of the seal 114d. In some configurations, a combination of surface textures, including but not limited to those described herein, can be used.

In some configurations, the textured portions are positioned outboard of the nostril locators 120d. In some configurations, the textured portions are positioned entirely outboard of the nostril locators 120d. In some configurations, the textured portions can surround, generally surround or be positioned generally adjacent to the nostril locators 120d. In such locations, the textured portions can reduce the contact surface area with the skin of the user while still maintaining an adequate seal against the face of the user. By reducing the contact surface area between the face of the user and the seal 114d, the contact region is perceived by the user to be cooler. Because, in some configurations, other regions besides the regions having the textured surfaces define a primary seal with the face, the textured surfaces can improve comfort without significantly deteriorating the seal present between the seal 114d and the face.

The interface illustrated in <FIG> is a construction that has integrated both the seal <NUM> and the nostril locators <NUM> into a single component. With reference now to <FIG>, the interface also can comprise masks with separable nostril locators and seals. By providing separability between the seal and one or more of the nostril locators, the mask can be better adapted for use by users having different facial geometries. For example, different separable components can have different sizes. In some configurations, the inflating seal can be universal while the nostril locators can be exchanged depending upon the size desired by the user. In some configurations, the seal could be provided in different geometries, such as, for example but without limitation, a wide version and a narrow version.

With reference now to <FIG>, the illustrated interface 100e comprises a seal 114e with a separable nasal insert <NUM> and seal member <NUM>. While the seal 114e is formed from more than one component, the seal 114e otherwise can be configured generally in the same manner as the seal <NUM> shown in <FIG> and described above. For example, the seal 114e can be configured with more supple and less supple regions similar to the seals disclosed above.

The nasal insert <NUM> comprises at least one nostril locator <NUM>. The nostril locators <NUM> can sit atop a main body <NUM>. In the illustrated configuration, two nostril locators <NUM> are integrally formed with the main body <NUM>. In some configurations, the two nostril locators <NUM> can be separable from the main body <NUM>.

The main body <NUM> comprises a plug portion <NUM> and the seal member <NUM> comprises a socket portion <NUM>. The plug portion <NUM> can be received within the socket portion <NUM> as indicated by the arrow in <FIG>. In some configurations, the plug portion <NUM> locks into position within the socket portion <NUM>. In some configurations, the plug portion <NUM> is secured by a friction fit within the socket portion <NUM>. Other suitable techniques for securing the plug portion <NUM> and the socket portion <NUM> can be used.

A distal end <NUM> of the main body <NUM> comprises an inlet opening and, proximal of the inlet opening, the main body <NUM> comprises one or more openings <NUM>. The inlet opening can be connected to the flexible supply conduit <NUM>. The seal member <NUM> comprises one or more internal voids or openings <NUM> and, when the plug portion <NUM> is positioned within the socket portion <NUM>, the one or more internal voids or openings <NUM> can be in fluid communication with the one or more openings <NUM>. Thus, in the configuration of <FIG>, the gases flow from the flexible conduit, into the nasal insert <NUM> and a portion of the gases flow from the nasal insert <NUM> into the seal member <NUM> while a portion of the gases flow from the nasal insert <NUM> through the nostril locators <NUM> to the user.

With reference to <FIG>, a nasal insert 190a and a seal member 192a can combine to define a mask. The nasal insert 190a can have an inlet at a plug portion 200a, which is located at a distal end of the nasal insert 190a. The inlet can be formed by the plug portion 200a. The seal member 192a, however, can have a distal inlet (not shown) that connects directly to a supply conduit (i.e., connects to the supply conduit rather than receiving flow from the nasal insert 190a) and an outlet that connects to the nasal insert 190a. The nasal insert 190a may include but does not require the openings used in the configuration of <FIG>. Thus, in the configuration shown in <FIG>, gases are supplied to the seal member 192a first and the seal member 192a passes the gases on to the nasal insert 190a through the inlet at the distal end of the nasal insert 190a prior to the nasal insert 190a passing the gases from the nasal insert 190a to the nostril locators 194a.

With reference now to <FIG>, a further multi-piece seal construction will be described. The multi-piece construction enables customization of the seal to the user. For example, different size nostril locators can be used with a universal seal member or different size seal members. In addition, nostril locators having differing stiffness or rigidity can be used and/or seal members with different levels of stiffness can be used. In some configurations, the seal member and the nostril locators can be formed of the same material. In some configurations, the seal member and the nostril locators can be formed of differing grades of the same material.

The seal member 192b shown in <FIG> comprises one or more outlet openings <NUM> formed on a proximal surface. In the illustrated configuration, the seal member 192b comprises two openings <NUM> that receive individual nostril locators <NUM>. The openings <NUM> can define sockets while distal ends <NUM> of the nostril locators <NUM> can define plugs. As illustrated in <FIG>, the distal ends <NUM> fit into the openings <NUM>. The nostril locators <NUM> can be connected to the seal member 192b in any suitable manner. In some configurations, the nostril locators <NUM> can be friction fit into the openings <NUM>. In some configurations, the distal ends <NUM> and the openings <NUM> can be configured to connect in only one rotational orientation. In some configurations, the rotational orientation can be varied to customize the fit of the nostril locators <NUM>. In some configurations, the relative rotational orientation between the openings <NUM> and the nostril locators <NUM> can be indexable such that the two can be rotationally adjusted and secured in a desired rotational position.

With reference now to <FIG>, a seal <NUM> is illustrated that features a separable nasal insert <NUM> and seal member <NUM>. The seal <NUM> can be similar to the construction of any of the configurations described above. In some configurations, however, the nasal insert <NUM> comprises an auxiliary component <NUM>. As illustrated in <FIG>, the auxiliary component <NUM> can be positioned between the one or more nostril locators <NUM> and a base <NUM> of the nasal insert <NUM>. In some configurations, a rim <NUM> can encircle the one or more nostril locators <NUM> and the auxiliary component <NUM> can be positioned between the rim <NUM> and the base <NUM>. In some configurations, the rim <NUM> can be positioned between the one or more nostril locators <NUM> and the auxiliary component <NUM>. In the illustrated configuration, the base <NUM> of the nasal insert <NUM> can comprises one or more opening <NUM> but need not.

The seal member <NUM> can be supple, as described above. In the illustrated configuration, the seal member <NUM> comprises an opening <NUM> that receives at least a portion of the nasal insert <NUM>. The opening <NUM> and the auxiliary component <NUM> are supple enough to enable the auxiliary component <NUM> of the nasal insert <NUM> to be inserted into the pocket defined within the walls of the seal member <NUM>. In some configurations, the opening <NUM> seals about a portion of the nasal insert <NUM> between the auxiliary component <NUM> and the rim <NUM>.

The rim <NUM> and the auxiliary component <NUM> can be separated by a gap, a recess, a channel, or a groove, for example but without limitation. The seal member <NUM> can include a lip that is received within the gap, recess, channel or groove that can be defined between the rim <NUM> and at least a portion of the auxiliary component <NUM>. In other words, the auxiliary component <NUM> can overlie, and can be separated from, at least a portion of the rim <NUM>. The gap between the auxiliary component <NUM> and the rim <NUM> can be sized and configured to receive at least a portion of the seal <NUM>. In this manner, the seal member <NUM> and the nasal insert <NUM> can be secured together, for example but without limitation. Moreover, in the illustrated configuration, the seal member <NUM> and the nasal insert <NUM> can be sealed together.

With reference now to <FIG>, a sampling of different constructions of auxiliary components will be described. A nasal insert 216a is shown in <FIG> in which the auxiliary component 220a comprises a slightly curved blade member <NUM>. The blade member <NUM> extends laterally outward beyond the nostril locators 222a and laterally outward beyond an outermost extent of the rim 230a that generally encircles the nostril locators 222a. The blade member <NUM> can be formed integrally with the nasal insert 216a or can be formed separate of the nasal insert 216a and secured thereto in any suitable manner. In some configurations, the blade member <NUM> is formed of silicone. The blade member <NUM> can be a resilient member that has the ability to bend into a first position and a second position. In some configurations, the blade member <NUM> can be a member that is bi-directionally stable. In other words, the blade member <NUM> can assume two distinct positions with sufficient stability to remain at least temporarily in those positions. In some configurations, the blade member <NUM> has sufficient resilience to assume a first shape or position when the associated seal member 218a is underinflated or not inflated. In some configurations, the blade member <NUM> will bend or deflect when the associated seal member 218a is inflated for use. Such a configuration is shown in <FIG> in which the outermost portions of the blade member <NUM> have been deflected upwardly.

As shown in <FIG>, the blade member <NUM> provides added material that contacts one or more inner surface of a seal member. The blade member <NUM> can be configured to urge the seal member 218a into an open position to assist with fitting of the mask on the face of the user by can deflect out of the way during use of the interface by the user. By slightly opening the mask, the nostril locators 222a can be mated with the nostrils more easily. Once gas pressure is supplied to the seal member 218a, the seal member will inflate and balloon into sealing engagement with the face of the user. Preferably, the blade member <NUM> is supple enough that, once the seal member 218a starts to inflate, the blade member <NUM> can bend and conform to the shape of the seal member 218a such that the seal member 218a can inflate and seal around the nose of the user.

<FIG> illustrates a nasal insert 216b that is similar in some respects to the nasal insert 216a shown in <FIG>. A rim 230b of the nasal insert 216b in <FIG> comprises a loop member <NUM>. The loop member <NUM> is similar to the blade member <NUM> in some respects; however, the loop member <NUM> extends both proximally and distally while also extending laterally outward. In other words, as apparent from comparing <FIG> with <FIG>, while the blade member <NUM> is generally a flat dish-shaped component in <FIG>, the loop member <NUM> is less flat and extends both fore and aft. As such, the loop member <NUM> facilitates manipulation of the proximal portion of the associated seal member 218b but also facilitates manipulation of the distal portion of the seal member 218b. In other words, whereas the blade member <NUM> contacts the inner surface on the distal portion of the seal member, the loop member <NUM> is capable of contacting the inner surfaces on the proximal and distal portions of the seal member 218b.

With continued reference to <FIG>, the loop member <NUM> extends laterally outward of the nostril locators 222b and outward beyond an outermost extent of the rim 230b. The loop member <NUM> can be formed integrally with the nasal insert 216b or can be formed separate of the nasal insert 216b and secured thereto in any suitable manner. In some configurations, the loop member <NUM> can be formed of silicone.

By contacting the inner surfaces of the seal member 218b, the loop member <NUM> places the seal member 218b in an opened position prior to inflation of the seal member 218b and provides an initial shape to the deflated seal member 218b. Once gas pressure is supplied to the seal member 218b, the seal member 218b will inflate and balloon into sealing engagement with the face of the user. Preferably, the loop member <NUM> is supple enough that, once the seal member 218b starts to inflate, the loop member <NUM> can bend and conform to the shape of the seal member 218b such that the seal member 218b can inflate and seal around the nose of the user. In some configurations, the loop member <NUM> can toggle between two positions. In some configurations, the loop member <NUM> can be structured to simply deflect out of the opened or first position as the seal inflates but resume the opened or first position when the seal once again deflates.

<FIG> illustrates a nasal insert 216c having an auxiliary component 220c that is inflatable. The auxiliary component 220c comprises one or more stabilizers <NUM>. The stabilizers <NUM> can have one or more outer wall and can be inflatable. Thus, an inner pocket defined within the stabilizer <NUM> can communicate with a gas source, such as the flow through the associated seal member 218c. In the illustrated configuration, the stabilizers <NUM> can be connected to the base 224c of the nasal insert 216c. The ballooning stabilizers <NUM> can provide a force to urge the proximal surface of the seal member toward the face of the user when at operating pressures. Thus, different from the loop member <NUM> and the blade member <NUM>, the ballooning stabilizers <NUM> do not serve to hold the uninflated mask in an open position; the stabilizers <NUM> provide an improved sealing force during use.

With reference to <FIG>, a nasal insert 216d is illustrated with an auxiliary component 220d that can flex between a first position P1 and a second position P2. The auxiliary component 220d can comprise a dish member <NUM> that is stable in the first position P1 and in the second position P2. In some configurations, the dish member <NUM> can flip between the first position P1 and the second position P2 but will return to the first position P1 with the application of minimal force. As shown in <FIG>, the dish member <NUM> can be flexed into the second position P2 for donning of the mask. With the dish member <NUM> in the second position P2, the seal member 218d can be held in the open position. Once positioned as desired on the user, a slight urging of the dish member <NUM> toward the face of the user causes the dish member <NUM> to pop back into the first position P1, which allows the seal member 218d to move to a more closed position.

Accordingly, to don the mask with the assembly illustrated in <FIG>, the dish member <NUM> can be flexed from the first position P1 to the second position P2. The dish member <NUM> temporarily is stabilized in the second position as the mask is being positioned such that the nostril locators 222d can be positioned within the nostrils of the user. As the mask is brought into engagement with the face of the user, the forces applied through the seal member 218d transfer to the dish member <NUM>, which pops back or otherwise returns to the first position P1. With the dish member <NUM> in the first position, the seal member 218d can close around the tip of the nose of the user, which allows the mask with the assembly illustrated in <FIG> to seal around the tip of the nose of the user.

With reference now to <FIG>, a portion of a seal member <NUM> is shown. The seal member <NUM> can be configured in accordance with any combination of features of any of the constructions described within this specification, for example but without limitation. The seal member <NUM> can comprise a distal wall <NUM> and a proximal wall <NUM>. An opening <NUM> can be defined within the distal wall <NUM>. A supply of gases can pass into the seal member <NUM> through the opening <NUM>.

As shown in <FIG>, the distal wall <NUM> can have a thicker cross-section, for example, relative to the proximal wall <NUM>. The thicker cross-section provides increased rigidity to the distal wall <NUM> relative to the proximal wall <NUM>. In some configurations, the thickness of the walls can be the same while the material used has an increased rigidity. In some configurations, both the thickness and the rigidity of the material can be used to provide differing degrees of rigidity.

In the illustrated configuration of <FIG>, a nostril locator <NUM> can be positioned along the proximal wall <NUM>. The illustrated nostril locator <NUM> can generally taper such that it narrows toward a proximal opening <NUM>. As such, the proximal opening <NUM> may have a smaller diameter than a distal opening into the nostril locator <NUM>. Generally speaking, the nostril locator <NUM> can taper in a proximal direction.

To improve lateral stability of the mask assembly, outriggers or other support structures can be used. In the configurations illustrated in <FIG>, however, the support structures are shown integrated into the structure of the seal member <NUM> itself. With reference to <FIG>, a support structure <NUM> is shown that is integrated into the seal member <NUM>. With the integrated support structure <NUM>, the mask is more comfortable than other masks that might use separate support structures that are more rigid than the seal member. Moreover, because the support structure <NUM> can be directly adjacent to the user's face, the integrated design provides for better support to the sealing member <NUM>.

The illustrated support structure <NUM> can be one or more thickened regions. For example, where the seal member <NUM> if formed of silicone, the support structure <NUM> can be a thickened region of silicone. In some such configurations, the support structure <NUM> can be molded into the seal member <NUM>. In some configurations, foam could be injected or inserted into the support structure <NUM>. For example, in some such configurations, the support structure <NUM> can be formed with a hollow region (or material could be removed) and the region can be filled with any desired gel or foam substance. In some configurations, the support structure <NUM> can be formed of silicone and the hollow region can be filled with a different grade of silicone. Such composite support structures can reduce the weight of the seal and mask assembly.

By molding the support structure <NUM> into the seal member <NUM>, the support structure can flex with the seal member <NUM>. Flexing of the seal member <NUM> allows the seal member <NUM> to better fit different face shapes. Additionally, the support structure <NUM> can move with the seal member <NUM> and the seal member <NUM> can sit closer to the face. Furthermore, integration of the support structure <NUM> into the seal member <NUM> simplifies manufacture of the mask because, by integrating the support structure <NUM> into the seal member <NUM>, the support structure is not separately formed or formed by an overmolding process. Moreover, the integration reduces the weight of the assembly while also facilitating a reduced size.

With reference to <FIG>, the illustrated support structure <NUM> is a crescent shaped member that generally underlies the seal member <NUM>. With reference to <FIG>, in some configurations, the support structure <NUM> can wrap upward along one or more of the outer (distal) side walls <NUM>. Thus, as shown, the support structure <NUM> can be provided in a variety of shapes. The shape of the support structure <NUM> can be tailored to provide support to the seal member <NUM> wherever desired because the support structure <NUM> can be molded in an integrated construction. While the configuration of <FIG> illustrate a structure that provides support just above a lip region of a user, the configuration of <FIG> reassigns the support to a cheek region rather than the fairly narrow region above the lips and below the nose. Thus, in the configuration of <FIG>, the support is shifted to the outside toward the cheeks, away from the upper lip. In some configurations similar to the configuration of <FIG>, the support remains on about the bottom half of the seal member <NUM> even though the support structure <NUM> wraps vertically upward along the sidewall. By shifting the support structure <NUM> location, the comfort of the seal member <NUM> can be improved while also improving the performance of the seal member <NUM>.

With reference now to <FIG>, another mask seal member <NUM> is illustrated. The mask seal member <NUM> comprises a distal wall <NUM> and a proximal wall <NUM>. One or more nostril locators <NUM> can be positioned on at least a portion of the proximal wall <NUM>. The nostril locators <NUM> can have any suitable configuration. In some configurations, the nostril locators <NUM> taper upwardly to openings <NUM>.

As illustrated in <FIG>, the proximal wall <NUM> wraps proximally around the nostril locators <NUM> Moreover, the illustrated nostril locators <NUM> span a portion of the proximal wall <NUM> that is generally normal to a vertical bisecting plane P as well as a portion of the proximal wall that wraps proximally. Other configurations are possible. In the illustrated configuration, the proximal wall <NUM> extends more proximally than the proximal most portion of the nostril locators <NUM>. Because the seal member <NUM> has laterally extending portions <NUM> that wrap proximally, the laterally extending portions <NUM> may hold the nostril locators away from the nares on flatter user face profiles. To help provide improved flexibility, the seal member <NUM> can be reinforced in regions closer to the nose compared to the cheeks.

With reference to <FIG>, the seal member <NUM> can comprise a marginal surface <NUM> that connects the proximal wall <NUM> to the distal wall <NUM>. The marginal surface <NUM> in the illustrated configuration is wider at the bottom than at the top. As illustrated, the marginal surface can provide a wider portion on the bottom of the illustrated seal member <NUM>. The seal member <NUM> can have a thicker wall in the bottom corners while the proximal wall <NUM> can have a reduced thickness in the region surrounding or at least partially surrounding the nostril locators <NUM>. The thicker region of the bottom corners can extend upward and follow the generally vertical line illustrated in <FIG>.

While a majority of the entire seal member <NUM> can be configured to balloon, the thicker regions can be configured to balloon less than the regions with a reduced thickness. The thicker regions can help control ballooning such that the proximal surface experiences a majority of the ballooning compared to the marginal surface <NUM> and the distal surface <NUM>. Thus, the region surrounding the nostril locators <NUM> can balloon more while the lower corners balloon less, which increases comfort and improves sealing of the mask.

With reference again to <FIG>, the nostril locators <NUM> typically are configured to be positioned within the nares. In order to fit within the nares of the user, the nostril locators <NUM> can be stiff enough to resist crushing during fitting and use. As such, the proximal ends of the nostril locators <NUM> have been discovered to slightly pinch the septum or otherwise reduce the comfort of the user. Accordingly, removing some of the rigidity of the nostril locators <NUM>, and especially of the proximal ends of the nostril locators <NUM> and/or in a transition location between the nostril locators <NUM> and surrounding structure (described below with reference to <FIG>), can be desirable.

With reference now to <FIG>, a sealing member <NUM> is shown in cross-section. A nostril locator <NUM> is shown extending from a proximal surface <NUM>. The nostril locator <NUM> can include an opening <NUM>. In the illustrated configuration, the opening <NUM> can be defined by a rim <NUM>. The rim <NUM> preferably includes at least one interruption <NUM>. With reference to <FIG>, the illustrated interruptions <NUM> comprise a larger opening <NUM> that is connected to a slot <NUM> that intersects with the rim <NUM>. In the illustrated configuration, the rim <NUM> includes two interruptions <NUM>. The interruptions <NUM> are positioned to be at the top and the bottom of the opening <NUM> in the illustrated configuration. In other words, when positioned in the nares of the user, the interruptions <NUM> facilitate flexure in a lateral direction in the configuration illustrated in <FIG>.

In some configurations, the rim <NUM> that defines the opening <NUM> is generally elliptical and includes a longer axis L1 and a shorter axis L2, as shown in <FIG>. In such configurations, the interruptions <NUM> can be intersected by the longer axis L1. In some configurations, one or more interruption <NUM> can be positioned along the portion of the rim <NUM> that is above the shorter axis L2. For example, a single interruption <NUM> can be positioned on the upper side of the shorter axis L2. In some such configurations, the single interruption <NUM> can be positioned closer to the apex of that portion of the elliptical opening <NUM>. In some such configurations, the single interruption <NUM> can be intersected by the longer axis L1. In some such configurations, the single interruption <NUM> can be centered upon the longer axis L1.

With continued reference to <FIG>, the interruptions <NUM> define recesses into the nostril locators <NUM> that extend from the rim <NUM> into the material of the nostril locators <NUM>. The interruptions <NUM> can extend any suitable distance along the length of the nostril locator <NUM>. The length preferably is not so long as to create a leak path but long enough to allow some radial relief to the rim <NUM>. As the length of the interruptions <NUM> increases, the stiffness of the nostril locator <NUM> decreases.

With reference to <FIG>, other configurations of interruptions <NUM> are illustrated. As illustrated, the interruptions <NUM> can have many different shapes and can be moved away from a region of the nostril locators <NUM> that will contact the septum. As illustrated, the interruptions <NUM> can be as few as one or as many as desired. In some configurations, the interruptions <NUM> result in a serrated end to the nostril locator <NUM>. Other configurations also are possible.

With reference now to <FIG>, a sealing member <NUM> is illustrated. The sealing member <NUM> can have features, aspects and characteristics in common with any other configuration described herein. In the illustrated configuration, the sealing member <NUM> comprises at least one flexible prong <NUM>. In some configurations, the sealing member <NUM> can comprise two flexible prongs <NUM>. The flexible prongs <NUM> comprise a distal end that is connected to a proximal surface <NUM>. The flexible prongs <NUM> can extend generally proximally from the proximal surface <NUM>. The flexible prongs <NUM> can have one or more opening <NUM> that are positioned generally at a proximal end of the prongs <NUM>. In the illustrated configuration, the opening <NUM> can form a slit that extends generally vertically through the proximal most end.

The prongs <NUM> preferably comprise a stalk <NUM> that extends generally between the proximal surface <NUM> and the opening <NUM>. The stalk <NUM> can be configured to roll or otherwise deflect with ease. For example, a cross-sectional thickness of the material used to form the sealing member <NUM> and/or the flexible prongs <NUM> can be reduced that connects at least a portion of the prongs <NUM> to the sealing member <NUM>. In some configurations, a different material or a different grade of material can be used to provide increased mobility to the prongs <NUM>.

In the illustrated configuration, as shown by comparing <FIG>, the prongs <NUM> can be configured to telescope or extend/retract. By configuring the prongs <NUM> to extend, the prongs <NUM> can have increased flexibility. As illustrated, the prongs <NUM> can compress along the axial direction. By compressing, the prongs <NUM> can improve comfort when sealing against the nares of the user.

In some configurations, the prongs can be configured with a bellows-type shape. The bellows-type shape can provide axial compressibility. The pleated appearance of the bellows-type shape can be formed along all of the stalk <NUM> or just a portion of the stalk <NUM>. By providing the bellows-type shape, the stalk <NUM> also can allow the proximal end of the prongs <NUM> to wobble about the distal end of the prongs <NUM>. In other words, the proximal end of the prongs <NUM> can bend in all directions without rotation of the prongs <NUM>.

With reference now to <FIG>, a portion of a sealing member <NUM> is shown. In some configurations, the sealing member <NUM> includes nostril locators <NUM> similar to those described above. At least a proximal portion of the nostril locators <NUM> can be partially or fully covered with an end member <NUM>, as shown in each of <FIG>. The end members <NUM> can be formed of a material that is as soft as, or softer than, the material of the nostril locator <NUM>. In some configurations, the end members <NUM> can be partially or fully formed of a softer silicone material. In other words, the end members <NUM> can be used to provide increased comfort by being positioned over the proximal end of the nostril locators <NUM>.

The end member <NUM> can define openings <NUM> through which airflow from the nostril locator <NUM> can pass. In the illustrated configurations, the end members <NUM> have a rounded appearance. The softer material and the rounded shape facilitate rolling around the axis of the nostril locator <NUM>. The underlying nostril locator <NUM> can be sufficiently rigid to provide the structure while the cap formed by the end member <NUM> can improve the comfort. In some configurations, the proximal end of the nostril locator <NUM> can be enclosed with perforations or laterally extending openings to allow air to flow out of the nostril locator while the soft end member creates a seal with the nares of the user. In addition, in some such configurations, the end member <NUM> can have a larger outer diameter than the nostril locator <NUM> such that the nostril locator <NUM> can have improved flexibility while the end member provides an effective sealing component.

With reference now to <FIG>, a further seal member <NUM> is illustrated. The seal member <NUM> includes a multiple wall nostril locator <NUM>. In the illustrated configuration, the nostril locator <NUM> comprises a thin outer wall <NUM> and a thicker inner wall <NUM>. In some configurations, the outer wall <NUM> is spaced from the inner wall <NUM> such that the two walls are capable of relative movement. In some configurations, the inner wall <NUM> can terminate within the outer wall <NUM>. In other words, the outer wall <NUM> may extend further proximally relative to the inner wall <NUM>.

The inner wall <NUM> can comprise a foam or gel insert, for example but without limitation. The inner wall <NUM> underlies and supports the outer wall <NUM>. Thus, with the support of the separately formed inner wall <NUM>, the outer wall <NUM> could be formed of a very thin layer. In some configurations, the outer wall <NUM> can be a very thin silicone wall that is intermittently or substantially completely supported by the inner wall <NUM>, which can be a much softer material than the outer wall <NUM>.

With reference now to <FIG>, a seal member <NUM> is illustrated therein. The seal member <NUM> can include one or more nostril locators <NUM>. In some configurations, the seal member <NUM> can be configured such that the nostril locators <NUM> direct the airflow in a more upward direction. With reference to <FIG>, the nostril locators <NUM> are shown directing the airflow more rearwardly when compared to the nostril locators <NUM> shown in <FIG>. By raising the rearmost wall of the nostril locators (see <NUM>), for example, the trajectory of the airflow can be altered to a more upwardly directed flow. In some configurations, the nostril locators are configured such that the resultant airflow is more upwardly and forward. By redirecting the airflow in this manner, the airflow is not blown straight into the nose, which improves the comfort to the user. In some configurations, the nostril locators <NUM> can be positioned on a ball joint, for example but without limitation, such that the air flow can be tuned by the user as desired.

With reference now to <FIG>, the illustrated seal member <NUM> can be structured in any configuration described above. The configuration illustrated, however, features a proximal surface <NUM> that omits one or both nostril locators. In the illustrated configuration, one or more of the nostril locators is replaced by an opening <NUM> that is formed in the proximal surface <NUM>. Thus, the nostrils of the user can simply overlie an opening <NUM> that is formed in the proximal surface. The configuration of <FIG> shows a single opening <NUM> that can underlie one or both nostrils of the user while the configuration of <FIG> also shows a single protrusion <NUM> that can help indicate to the user when the mask is properly located under the nose. With reference to <FIG>, in some configurations, the tip of the nose can sit at the crossing <NUM> of the two facet lines. The protrusion <NUM> can be a short nostril locator, a complete nostril locator or any other suitable structure to help the user confirm a desired placement of the mask sealing member relative to the nostrils. In some configurations, the nose fits into or around the opening and the seal member can balloon around the nose of the user. For example, the tip of the nose can go into the opening or the opening can sit under the tip of the nose to provide seal. The ballooning improves sealing of the seal member, especially where nothing extends into the nares of the user.

With reference now to <FIG>, a further interface assembly <NUM> is illustrated that is arranged and configured in accordance with certain features, aspects and advantages of the present invention. The interface assembly <NUM> generally comprises a frame or body <NUM> and a seal <NUM>. The seal <NUM> can be removably secured to the frame <NUM> for use. In some configurations, multiple seals <NUM> can be provided for connection to the frame <NUM>, which can vary in size, shape, softness or any other desirable characteristic. In the illustrated configuration, the frame <NUM> provides attachment points for headgear or the like. Other configurations are possible.

The illustrated seal <NUM> incorporates a connecting or mounting assembly <NUM> that can be joined to the flexible seal member <NUM>. With reference to <FIG>, the seal member <NUM> comprises a proximal surface <NUM> (i.e., the surface that is closest to the face of the user in use) and a distal surface <NUM> (i.e., the surface further away from the face of the user in use). In the illustrated configuration, the distal surface <NUM> defines an inlet opening <NUM>. The opening <NUM> is configured to admit breathing gases into a chamber defined within the seal member <NUM>.

In the illustrated configuration, the opening <NUM> is circumscribed by a rib or protrusion <NUM>. The rib or protrusion <NUM> is best shown in the sectioned view of <FIG>. As illustrated, a portion of the seal member <NUM> that connects the rib or protrusion <NUM> to the distal surface <NUM> can extend generally normal or perpendicular to an axis of the inlet opening <NUM>. Thus, the rib or protrusion <NUM> is offset inwardly by a portion of the distal surface <NUM>. The radial offset allows the rib or protrusion to be captured by the mounting assembly <NUM>. Other configurations also are possible keeping in mind a desire to surface a more rigid mounting assembly <NUM> to the seal member <NUM>.

The mounting assembly <NUM> can be more rigid than the seal member <NUM>. In some configurations, the mounting assembly <NUM> can be formed as a two piece construction. For example, the mounting assembly <NUM> can capture the seal member <NUM> with an inner member <NUM> and an outer member <NUM>. The inner member <NUM> can be inserted through the inlet opening <NUM>.

The inner member can have a sleeve <NUM> that extends through the inlet opening <NUM>. The sleeve <NUM> can join with a larger diameter ridge <NUM>. The larger diameter ridge <NUM> can provide a location against which the rib or protrusion <NUM> of the seal member <NUM> can rest. The sleeve <NUM> can be externally threaded or include one or more outer protrusions <NUM>. The sleeve <NUM> also can include an inner coupler construction <NUM>. The outer threading or protrusions <NUM> can marry with a structure formed on an inner surface of the outer member <NUM>. The outer member extends radially outward sufficiently to capture the rib or protrusion <NUM> of the seal member <NUM> between the outer member <NUM> and the inner member <NUM>. In such a way, the mounting assembly <NUM> can be secured to the seal member <NUM>.

As described above, the sleeve <NUM> of the inner member <NUM> includes the inner coupler construction <NUM>. The inner coupler construction <NUM> mates with a corresponding structure on the frame <NUM> such that the seal <NUM> (i.e., seal member <NUM> and mounting assembly <NUM>) can be secured to the frame <NUM> for use and removed for replacement. The frame <NUM> can have a flange or the like with which the mounting assembly <NUM> is connectable. In the illustrated configuration, an inlet portion of the frame <NUM> (i.e., a socket for a ball and socket connection) can incorporate a recess while the mounting assembly <NUM> can incorporate a ridge but other suitable constructions can be used keeping in mind a desire for a secure enough connection for use but a removable connection for replacement of the seal <NUM>.

In some configurations, the frame <NUM> and the mounting assembly <NUM> can include orientation features. For example, in the illustrated configuration, the mounting assembly <NUM> can incorporate a tongue, protrusion or boss feature <NUM> while the frame <NUM> can incorporate a groove, recess or relief feature <NUM>. With the tongue <NUM> aligned with the groove <NUM>, the desired orientation between the seal <NUM> and the frame <NUM> can be ascertained. Other suitable configurations can be used keeping in mind a desire to obtain confirmation of correct alignment and orientation of the seal <NUM> to the frame <NUM>.

With reference now to <FIG>, the seal member <NUM> of one preferred construction will be described in further detail. As has been described, the seal member <NUM> can have regions of increased suppleness and regions of increased stiffness. The regions can result from differing materials, differing grades of the same material or differing thicknesses. In the illustrated configuration, there are regions of differing thickness. The thickest regions on the proximal surface <NUM> (shown in <FIG>) and the thickest regions on the distal surface <NUM> (shown in <FIG>) can be found in the rib or protrusion <NUM> surrounding the inlet opening <NUM> and in a central portion of the wings <NUM>. These regions are the regions used for mounting and for gripping and, as such, desirably are the thickest and stiffest regions. In addition, at least in the wing regions <NUM>, the thickest regions can support the thinner regions and provide some structure to the seal member <NUM>, as described below in greater detail. In some configurations, the thickness is <NUM> with some variation being possible slightly higher and lower keeping in mind a desire for this region to be sufficiently rigid for mounting and gripping.

The next thickest region is the joining region <NUM> that joins the rib or protrusion <NUM> to the balance of the seal member <NUM>. This region simply is thick enough to resist tearing of the seal member <NUM> at the connection between the rib or protrusion <NUM> and the balance of the seal member <NUM>. In some configurations, the joining region <NUM> has a thickness of about <NUM> with some variation being possible slightly higher and lower keeping in mind a desire to reduce or eliminate the likelihood of tearing during normal use.

As described above, nostril locators <NUM> can be positioned on the proximal surface <NUM>. The nostril locators <NUM> desirably are sufficiently supple to reduce or eliminate the likelihood of causing irritation. The nostril locators <NUM> also desirably are sufficiently stiff to reduce the likelihood of ballooning or being insufficiently self-supporting to provide an indication to the user of correct location and orientation of the seal <NUM> relative to the face. Preferably, the nostril locators <NUM> have sufficient stiffness to inhibit or prevent significant collapse in response to positioning of the locators <NUM> in the user's nostrils. In some configurations, the nostril locators <NUM> can have a thickness of about <NUM> with some variation being possible slightly higher and lower keeping in mind a desire to reduce user discomfort while still assisting with mask positioning.

As described above, some regions of the seal member <NUM> can be configured for ballooning, inflating or the like. By having such distensible surfaces, the seal member <NUM> can provide more effective sealing while accommodating slight movements of portions of the seal member <NUM> relative to the face of the user in use. In effect, the nostril locators <NUM> can be somewhat decoupled from the frame <NUM> through the most supple regions of the seal member <NUM>, which regions surround and isolate the nostril locators <NUM> from the balance of the mask in the illustrated configuration. As such, a surround region <NUM> can be defined to generally encircle the nostril locators <NUM>. The surround region <NUM> can extend to a transition between the proximal surface <NUM> and the distal surface <NUM>. In some configurations, the surround region <NUM> has a thickness of about <NUM> with some variation being possible slightly higher and lower keeping in mind a desire to allow some decoupling between the relatively more rigid nostril locators <NUM> and the balance of the seal member <NUM>.

Other than the identified regions, the remainder of the illustrated seal member <NUM> can be a transition of wall thicknesses among the identified wall thicknesses. The illustrated seal member <NUM> is but one desired configuration and certain variations are possible.

As described above, as illustrated in <FIG> among others, the side portions or wing regions <NUM> can comprise stiffened regions in the form of thickened regions <NUM> that support thinner regions of the body of the seal member <NUM>, such as the surround region <NUM>. The thickened regions <NUM> can be mirror images of one another, as can the wing regions <NUM> such that the seal member <NUM> has symmetry about a central, vertical plane. The thickened regions <NUM> can extend along a substantial portion of the length and/or height of the wing regions <NUM> or of the seal member <NUM>. In the illustrated arrangement, the thickened regions <NUM> extend substantially the entire length and substantially the entire height of the wing regions <NUM>, which wing regions <NUM> can extend substantially the entire height and length of the seal member <NUM>. Thus, in some configurations, the thickened regions <NUM> are essentially the same size and shape as the distal surfaces <NUM> of the wing regions <NUM>.

The thickened regions <NUM> can be of substantially constant or varied thickness. In the illustrated arrangement, peripheral portions or edge portions of the thickened regions <NUM> are reduced in thickness relative to central portions of the thickened regions <NUM>. In particular, forward edge portions of the thickened regions <NUM> reduce in thickness relative to adjacent portions and/or central portions and transition into the joining region <NUM> and rib <NUM> to accommodate the mounting assembly <NUM>. Preferably, the forward edge portions of the thickened regions <NUM> have a greater thickness than the joining region <NUM> at least until a junction between the thickened regions <NUM> and the joining region <NUM>. In the illustrated configuration, the forward edge portions of the thickened regions <NUM> gradually reduce in thickness toward the junction with the joining region <NUM>.

Similarly, rearward edge portions of the thickened regions <NUM> also reduce in thickness relative to adjacent portions and/or central portions of the thickened regions <NUM>. Such an arrangement preserves the suppleness of the rearward edge portions of the proximal surface <NUM> while inhibiting or preventing significant ballooning or distending of the rearward edge portions of the distal surface <NUM>. Advantageously, such an arrangement allows the seal member <NUM> to provide adequate sealing functionality on outside portions of the user's nose while also providing a feeling of stability for the user because any significant ballooning of the rearward edge portions of the distal surface <NUM> can be limited or avoided.

With reference to <FIG>, a rearward edge of the seal member <NUM>, which can also be referred to as a rim or marginal surface, can comprise a transition portion <NUM> between the proximal surface <NUM> and the distal surface <NUM>. In the illustrated configurations, the transition portion <NUM> comprises a generally rounded or curved wall portion. As described, in some configurations, the thickened regions <NUM> begin to taper in thickness forward of the transition portion <NUM>. However, preferably, a portion of the transition portion <NUM> has a greater thickness than the supple proximal surface <NUM> or surround region <NUM> to control ballooning of the seal member <NUM> and, preferably, limit or prevent any substantial ballooning of the distal surface <NUM>. In the illustrated arrangement, the rearward edge portions of the thickened regions <NUM> taper in thickness relatively quickly toward the transition portion <NUM>, which then gradually tapers in thickness from the distal surface <NUM> to the proximal surface <NUM>. In some configurations, the transition portion <NUM> can have a portion defining a wall thickness that is approximately the same as the thickness of the supple proximal surface <NUM>, such as the surround region <NUM>.

As illustrated in <FIG>, <FIG>, possibly among others, the lower, rearward corners of the wing regions <NUM> comprise outwardly-protruding portions or outwardly-protruding corners <NUM>. The outwardly-protruding corners <NUM> flare outwardly relative to adjacent portions of the wing regions <NUM> to be positioned generally at locations corresponding to the cheek or upper lip of the user laterally outward of the nose. In some configurations, the outwardly-protruding corners <NUM> are located approximately over the portions of the upper lip overlying the canine or cuspid teeth of the user. The outwardly-protruding corners <NUM> can assist in anchoring the seal member <NUM> on the user's face. In some configurations, this arrangement allows additional stability elements to be omitted while still providing the user with a sense of sufficient stability such that the seal member <NUM> is the only portion of the mask that contacts the user's face. The sense of stability can be communicated to the user at least partially due to the outwardly-protruding corners <NUM> having a relatively high stiffness. Thus, preferably, the thickened regions <NUM> extend at least partially into to the outwardly-protruding corners <NUM> and, in some configurations, can extend at least substantially completely through the outwardly-protruding corners <NUM>. Preferably, at least the rearmost and lowermost portions of the distal surface <NUM> of the seal <NUM> comprise the thickened regions <NUM>. Within the outwardly-protruding corners <NUM>, the thickened regions <NUM> can taper in thickness into the transition portion <NUM> as described above.

As described above, the wing regions <NUM> can be used as gripping portions of the seal <NUM> for the initial positioning of the mask on the face, repositioning of the mask on the face, removing or coupling the seal <NUM> from or to the frame or body <NUM>, among other reasons. As described, the thickened regions <NUM> can facilitate gripping of the seal <NUM> on the distal surface within the wing regions <NUM> by limiting collapse of the seal <NUM> in response to squeezing of the wing regions <NUM>. In some configurations, the distal surface <NUM> of the seal <NUM> can include surface features (e.g., one or more recesses or protrusions) configured to facilitate gripping. Such features can be referred to as grip surfaces or grips.

The illustrated wing regions <NUM> each include a grip surface <NUM> formed by a protrusion <NUM>. The protrusion <NUM> extends outwardly from adjacent surfaces to an extent sufficient to provide some degree of resistance to slipping of a user's fingers along the surface of the seal <NUM>. The illustrated protrusion <NUM> is generally crescent-shaped, which defines a generally scallop-shaped grip surface <NUM>. The ends of the protrusion <NUM> are positioned rearward of the center, curved portion of the protrusion <NUM>. The user's fingers or thumb can be placed in the grip surface <NUM> and the user can push against the protrusion <NUM> when mounting the seal <NUM> to the frame or body <NUM>. Thus, the protrusion <NUM> compensates for the inwardly-tapered or curved shape of the seal <NUM> that may otherwise allow the user's fingers or thumb to slide along the distal surface <NUM> of the seal <NUM>. The grip surface <NUM> and/or protrusion <NUM> may also assist the user in removing the seal <NUM> from the frame or body <NUM> or otherwise positioning or repositioning the mask. Other suitable grip arrangements can also be provided, such as multiple protrusions, recesses or other surface features that enhance grip relative to a smooth surface. Materials or material treatments that improve grip could also be employed.

The seal <NUM> could alternatively or additionally include other features that define grip surfaces or grips. For example, with reference to <FIG> and <FIG>, the seal <NUM> can include a relatively rigid grip <NUM>. In the illustrated arrangement, the rigid grip <NUM> is defined by a rigid support member of the seal <NUM>, such as the mounting assembly <NUM> and, in particular, the outer member <NUM> of the mounting assembly <NUM>. The illustrated grip <NUM> is defined by a rearwardly-protruding portion or tab of the outer member <NUM>, which can extend rearwardly of an annular portion of the outer member <NUM> over the distal surface <NUM> of the seal <NUM>. The seal <NUM> can define a recess that accepts the grip <NUM> and an outer surface of the grip <NUM> can be aligned with an adjacent outer surface of the seal <NUM>. The inner member <NUM> can include a portion <NUM> that also extends rearwardly in general alignment with the grip <NUM> but within the interior space of the seal <NUM> to capture the seal between the grip <NUM> and the rearward extending portion <NUM> of the inner member <NUM>. The grip <NUM> can define one or more surface features <NUM> that enhance grip, such as one or more protrusions or recesses.

The illustrated grip <NUM> is located on the top of the seal <NUM>. Additional or alternative locations include the bottom of the seal <NUM> or either side of the seal <NUM>. For example, opposed pairs of grips <NUM> can be provided on the top and bottom and/or sides of the seal <NUM>. In some configurations, the grip surfaces <NUM> and/or protrusion <NUM> can be defined by a rigid structure, such as a portion (e.g., the outer member <NUM>) of the mounting assembly <NUM>. In some configurations, the mounting assembly <NUM> can include protruding portions or other rigid portions can be provided that extend a substantial length and/or height of the wing regions <NUM> of the seal <NUM>.

As described above, the nostril locators <NUM> can be at least somewhat decoupled from balance of the seal member <NUM>. In some configurations, the seal member <NUM> can be configured to provide for or facilitate preferential movement of the nostril locators <NUM>. In some such configurations, the seal member <NUM> can be configured to provide less resistance to tilting movement in at least one direction relative to at least one other direction. Preferably, the seal member <NUM> includes one or more features that provide for or facilitate outward tilting of the nostril locators <NUM> away from one another. That is, preferably, less resistance is provided for outward tilting of the nostril locators <NUM> relative to tilting in one or more other directions (e.g., inward, upward or downward). Such an arrangement can reduce discomfort that could otherwise occur as a result of the nostril locators <NUM> pinching the septum of the user's nose. The arrangements disclosed herein can be applied to other types of seals or patient interfaces, such as any arrangements incorporating nasal pillows or other sealing or non-sealing prong-like nasal elements.

Any suitable arrangement or structure can be used to provide for or facilitate preferential movement of the nostril locators <NUM>. In the illustrated arrangement, the seal member <NUM> includes thinned regions extending around at least a portion of the nostril locators <NUM>, which facilitate tilting or deflection of the nostril locators <NUM> and are referred to herein as deflection regions <NUM>. In some configurations, the deflection regions <NUM> are located in annular transition portions surrounding the nostril locators <NUM> between the nostril locators <NUM> and the surround region <NUM>. The transition portions can be formed partially or completely by the base portions of the nostril locators <NUM>, partially or completely by the portions of the surround region <NUM> adjacent the base portions of the nostril locators <NUM> or a combination of the two. In other configurations, the deflection regions <NUM> can be provided in another suitable location to allow preferential deflection of the nostril locators <NUM>.

In some configurations, the deflection regions <NUM> are located on the bases of the nostril locators <NUM> and, in the illustrated arrangement, substantially completely on the bases of the nostril locators <NUM>. The deflection regions <NUM> can comprise thin-walled sections of the bases of the nostril locators <NUM>. The thin-walled sections have a lower thickness than other portions of the nostril locators <NUM>. In some configurations, the thin-walled sections defining the deflection regions <NUM> can be the thinnest portions of the nostril locators <NUM>. In some configurations, the thin-walled sections have a wall thickness that is about one-half or less than about one-half of a wall thickness of a substantial portion or a remainder of the nostril locators <NUM>. For example, in some configurations, the thin-walled sections of the deflection regions are about <NUM> thick and at least the primary portions of the nostril locators <NUM> are about <NUM> thick. In some configurations, the tips of the nostril locators <NUM> are thinned for comfort. However, with the provision of the deflection regions <NUM>, the tips can be the same or substantially the same wall thickness as other portions of the nostril locators <NUM> to improve user feedback and inhibit collapse upon insertion into the nostrils while also being comfortable during use. The thin-walled sections defining the deflection regions <NUM> can have a greater thickness than the surround region <NUM>.

The deflection regions <NUM> preferably extend around only a portion of the respective perimeters of the nostril locators <NUM>. In some configurations, the deflection regions <NUM> are limited to about one-half or less of the perimeters of the nostril locators <NUM>. In some configurations, the deflection regions <NUM> are limited to an outer side of the perimeters of the nostril locators <NUM>. In the illustrated arrangement, the deflection regions <NUM> extend around greater than or equal to about one-third, but less than or equal to about one-half of the respective perimeters of the nostril locators <NUM>.

With reference to <FIG> in particular, the outlet apertures <NUM> defined by the nostril locators <NUM> are generally oval in shape and each define a major axis <NUM> along the largest width of the outlet aperture <NUM> and a minor axis <NUM> that is perpendicular to the major axis <NUM>. In some configurations, the deflection region <NUM> is substantially or completely limited to one side (e.g., the outer side) of the major axis <NUM>. A lower end of the deflection region <NUM> can be at or near the major axis <NUM> and an upper end of the deflection region <NUM> can be spaced from the major axis <NUM>. Such an arrangement can permit tilting in an outward and slightly downward direction relative to the major axis <NUM>. The length and/or position of the deflection regions <NUM> can be altered to provide for a desired direction of tilting or deflection. In some configurations, if the lower end of the major axis <NUM> is assumed to be <NUM> degrees, the deflection regions <NUM> can extend from about <NUM> degrees to about <NUM> degrees.

At least in part because of the provision of the deflection regions <NUM> and other features described herein, the geometry of the seal member <NUM> of <FIG> has been modified relative to the geometry of the nasal seal presently commercialized by the Applicant, Fisher & Paykel Healthcare Limited, in the Pilairo® nasal mask. For example, the major axes <NUM> have been rotated toward vertical by about <NUM> degrees relative to the orientations of the current Pilairo® nasal mask. Relative to a central, vertical plane passing through the seal member <NUM>, the major axes <NUM> are oriented at an angle of about <NUM>-<NUM> degrees with the lower ends of the major axes <NUM> being further outward (further from the central plane) than the upper ends of the major axes <NUM>. The surface defining the tips of the nostril locators <NUM> have been rotated outwardly by about <NUM> degrees relative to the current Pilairo® nasal mask such that the surfaces define an angle of about <NUM>-<NUM> degrees with the central plane with the outer portions of the tips of the nostril locators <NUM> being further rearward than the inner portions. The length of the nostril locators <NUM> has been reduced by about <NUM> to about <NUM>. The outlet aperture <NUM> defines a more round shape. For example, the dimension along the major axis <NUM> can be about <NUM> and the dimension along the minor axis can be about <NUM>. The nostril locators <NUM> are also spaced slightly wider apart. For example, the spacing of the major axes <NUM> at the bases and the tips of the nostril locators <NUM> can be about <NUM> and about <NUM>, respectively.

With reference to <FIG>, a further interface assembly <NUM> is illustrated that is arranged and configured in accordance with certain features, aspects and advantages of the present invention. The interface assembly <NUM> generally comprises a frame or body <NUM> and a seal <NUM>. The seal <NUM> can be removably secured to the frame <NUM> for use. In the illustrated configuration, the frame <NUM> provides attachment points for headgear or the like. The illustrated seal <NUM> incorporates a connecting or mounting assembly <NUM> that can be joined to the flexible seal member <NUM>. The seal member <NUM> comprises a proximal surface <NUM> (i.e., the surface that is closest to the face of the user in use) and a distal surface <NUM> (i.e., the surface further away from the face of the user in use). The interface assembly <NUM> is described in the context of the differences relative to other interface assemblies described herein. Thus, features that are not described can be assumed to be the same as or similar to corresponding features of the other interface assemblies disclosed herein, or can be of another suitable arrangement.

The seal member <NUM> of <FIG> preferably includes features that facilitate or promote deflection of an upper, central portion of the seal member <NUM> that is aligned with the user's nose to inhibit or prevent excess pressure from being applied to the nose. In some configurations, portions of the seal member <NUM> defining both the proximal surface <NUM> and the distal surface <NUM> in the central portion deflect forwardly to accommodate a user's nose. That is, in some configurations, the entire upper, central portion of the seal member <NUM> can deflect in a forward direction rather than the proximal surface <NUM> simply moving closer to the, often substantially stationary, distal surface <NUM>, which can cause stretching of the proximal surface <NUM> and, thus, discomfort. Deflection of the seal member <NUM> may not occur in all situations. For example, certain facial geometries may result in little to no deflection, while other facial geometries may result in significant deflection.

The illustrated seal member <NUM> includes a rib or protrusion <NUM> that provides for connection to the connecting or mounting assembly <NUM>. A joining region <NUM> can connect the rib or protrusion <NUM> to the balance of the seal member <NUM>. In some configurations, portions of the joining region <NUM> can have a thickness of about <NUM> with some variation being possible slightly higher and lower keeping in mind a desire to reduce or eliminate the likelihood of tearing during normal use. However, the upper, central portion <NUM> of the seal member <NUM>, which may include portions of the joining region <NUM>, preferably has a lower wall thickness to facilitate or promote deflection (illustrated in broken line). The wall thickness of the upper, central portion <NUM> can be the same as or similar to the surround region <NUM> of the seal member <NUM> of <FIG>, such as about <NUM>, for example. In some configurations, the upper, central portion <NUM> can be connected to or integrated with a surround region <NUM>, which surrounds nostril locators <NUM> of the seal member <NUM>. In the illustrated arrangement, the reduced wall thickness of the upper, central portion <NUM> begins substantially immediately outward of the connecting or mounting assembly <NUM>. Other suitable arrangements to permit deflection and/or rolling movement of the upper, central portion <NUM> of the seal member <NUM> can also be used, such as the concepts and arrangements disclosed in <CIT>.

Claim 1:
A nasal seal (<NUM>) configured to be removably coupled to a frame (<NUM>) of a patient interface (<NUM>), the nasal seal (<NUM>) comprising:
a seal body (<NUM>) formed of a soft flexible material and defining an inner cavity and one or more delivery openings for supply of breathing gases from the inner cavity to a patient;
wherein the seal body (<NUM>) comprises a central portion and a side portion (<NUM>) extending from each end of the central portion, the seal body (<NUM>) further comprising an interior side and an exterior side, wherein the interior side of the central portion is configured to extend across a base of a user's nose and the interior side of each of the side portions (<NUM>) is configured to extend across a side of the nose, wherein the interior side of the seal body (<NUM>) is supple and configured to conform under internal pressure to surfaces of the user's nose, including, at the side portions (<NUM>) of the seal body (<NUM>), to outside surfaces of the side of the nose, wherein each of the side portions (<NUM>) defines a transition portion (<NUM>) between the exterior side and the interior side, wherein the exterior side of each of the side portions (<NUM>) comprises stiffened regions that are stiffer or much stiffer than the supple interior side, the stiffened regions extending to or substantially to the transition portions (<NUM>), wherein lower, rearward corners of the side portions (<NUM>) comprise outwardly-protruding corners (<NUM>) that flare outwardly relative to adjacent portions of the side portions (<NUM>), and wherein the stiffened regions extend at least partially into the outwardly-protruding corners (<NUM>).