Nasal mask interface assembly

Abstract

To provide an interface assembly for positive pressure treatment.SOLUTION: An interface assembly includes a nasal mask including a seal having a bending portion. The bending portion of the seal bends so as to cover a part of a clip fixing the seal to a frame. The frame has a ball socket type connection part with a connector. The connector includes an L-shaped tube having a vent hole and a swivel integrally molded.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention generally relates to an interface assembly for positive pressure therapy. More particularly, the present invention relates to a nasal mask interface assembly and a headgear.

Background Art

[0002] The interface can be used to supply breathing gas to a user under positive pressure. In a configuration that covers the user's nose, the nasal mask generally covers the nasal bridge. Generally, a part of the user's nose is surrounded by a single seal.

[0003] Such a nasal mask is usually fixed to the user's face using a headgear having a T-joint frame connected to a seal member. In order to sufficiently reduce leakage, generally, a high pressure is applied to the user's nasal bridge in order to tighten the headgear. In other words, as the headgear is tightened, the load applied to the nasal bridge by the silicone seal generally gradually increases. Pressure can cause discomfort and, in some cases, can lead to pressure ulcers over time.

Summary of the Invention

Problems to be Solved by the Invention

[0004] It is an object of the present invention to provide one or more configurations and / or methods that at least somewhat improve the above points or at least provide useful alternatives for the general public or medical professionals.

Means for Solving the Problems

[0005] In one aspect, a seal member for an interface assembly includes a facial contact surface. The facial contact surface includes an edge that at least partially defines an opening. The facial contact surface also includes a first cheek surface and a second cheek surface. The first cheek surface includes a first thickness portion, and the second cheek surface includes a second thickness portion.

[0006] Preferably, the first and second thick portions are formed on the inner surface of the sealing member.

[0007] Preferably, the distal portion of the sealing member is overmolded onto the clip member. Preferably, the clip includes an element that receives a complementary element of the interface frame. Preferably, the clip member is tapered in the distal direction.

[0008] In one aspect, the sealing member for the interface assembly includes a facial contact surface. The facial contact surface includes an edge that at least partially defines an opening. The facial contact surface also includes an upper lip contact surface, a first buccal surface, and a second buccal surface. Side walls extend distally from the facial contact surface. The side walls include a first lower corner near the transition from the upper lip surface to the first buccal surface. The side walls include a second lower corner near the transition from the upper lip surface to the second buccal surface. The cross-sectional thickness of the first lower corner and the second lower corner is greater compared to the portion of the side walls located above the first lower corner and the second lower corner when viewed longitudinally.

[0009] Preferably, the distal portion of the sealing member is overmolded onto the clip member. Preferably, the clip includes an element that receives a complementary element of the interface frame. Preferably, the clip member is tapered in the distal direction.

[0010] In one aspect, the sealing member for the interface assembly includes a facial contact surface. The facial contact surface includes an edge that at least partially defines an opening. The facial contact surface also includes an upper lip contact surface, a first buccal surface, and a second buccal surface. Side walls extend distally from the facial contact surface. The side walls include a first thickened strip extending along a portion corresponding to the first buccal surface and a second thickened strip extending along a portion corresponding to the second buccal surface.

[0011] Preferably, the distal portion of the seal member is overmolded onto the clip member. Preferably, the clip includes an element that receives a complementary element of the interface frame. Preferably, the clip member is tapered in the distal direction.

[0012] Preferably, the cross-section of the distal side of the side wall of the seal member in the first and second wall thickness bands is thicker than the cross-section of the proximal side of the first and second wall thickness bands.

[0013] Preferably, the distal portion of the seal member is overmolded onto the clip member. Preferably, the clip includes an element that receives a complementary element of the interface frame. Preferably, the clip member is tapered in the distal direction.

[0014] In one aspect, the headgear for the interface assembly includes a body. A first lower strap and a second lower strap extend from the body in opposite directions of the body. A first upper strap and a second upper strap extend from the body in opposite directions of the body. The first lower strap includes a centerline of the first lower strap. The second lower strap includes a centerline of the second lower strap. The first upper strap includes a centerline of the first upper strap. The centerlines of the first and second lower straps intersect each other and then intersect the centerline of the first upper strap.

[0015] Preferably, the second upper strap includes a centerline of the second upper strap, and the centerline of the first upper strap corresponds to the centerline of the second upper strap.

[0016] Preferably, the intersection of the centerline of the first lower strap and the centerline of the second lower strap is offset by a distance of about 23 mm from the centerline of the first upper strap.

[0017] Preferably, the centerline of the first lower strap intersects the centerline of the first upper strap at a position about 43 mm from the position where the centerline of the second lower strap intersects the centerline of the first upper strap.

[0018] Preferably, the center line of the first upper strap and the center line of the second upper strap are correlated with each other and do not intersect the entire body of the headgear.

[0019] Preferably, the center line of the first lower strap extends at an angle with respect to the center line of the first upper strap, and this angle is from about 20 degrees to about 50 degrees.

[0020] In one aspect, the L-shaped tube used in the interface assembly includes a body having a proximal end and a distal end. The proximal end and the distal end form an angle with respect to each other, and a bent portion is defined at the transition from the proximal end to the distal end. The bent portion includes a plurality of ventilation holes. The plurality of ventilation holes are formed integrally with the body of the L-shaped tube.

[0021] In one aspect, the L-shaped tube used in the interface assembly includes a body having a proximal end and a distal end. The proximal end and the distal end form an angle with respect to each other, and a bent portion is defined at the transition from the proximal end to the distal end. The bent portion includes a plurality of ventilation holes. One or more of the ventilation holes include a conical first portion and a trumpet-shaped second portion.

[0022] Preferably, the conical first portion is the inner portion, and the trumpet-shaped second portion is the outer portion.

[0023] Preferably, the ventilation holes are formed integrally with the body.

[0024] In one aspect, the interface assembly includes a frame, and a seal is detachably connected to this frame. The seal is configured according to any one of those described and / or illustrated in the present application.

[0025] In one aspect, the interface assembly includes a frame, and a headgear is detachably connected to this frame. The headgear is configured according to any one of those described and / or illustrated in the present application.

[0026] In one aspect, the interface assembly includes a frame to which a conduit connector is connected. The conduit connector includes an L-shaped tube configured according to any of those described and / or illustrated herein.

[0027] In one aspect, the interface assembly includes a frame to which a seal and a headgear are removably connected. The seal is configured according to any of those described and / or illustrated herein, and the headgear is configured according to any of those described and / or illustrated herein.

[0028] In one aspect, the interface assembly includes a frame to which a seal is connected and to which a conduit connector is connected. The conduit connector includes an L-shaped tube. The seal is configured according to any of those described and / or illustrated herein, and the L-shaped tube is configured according to any of those described and / or illustrated herein.

[0029] In one aspect, the interface assembly includes a frame to which a headgear is connected and to which a conduit connector is connected. The conduit connector includes an L-shaped tube. The headgear is configured according to any of those described and / or illustrated herein, and the L-shaped tube is configured according to any of those described and / or illustrated herein.

[0030] In one aspect, the interface assembly includes a frame to which a seal and a headgear are connected and to which a conduit connector is connected. The conduit connector includes an L-shaped tube. The seal is configured according to any of those described and / or illustrated herein. The headgear is configured according to any of those described and / or illustrated herein. The L-shaped tube is configured according to any of those described and / or illustrated herein.

[0031] In this specification, where reference is made to patent specifications, other external documents or other information sources, this is generally for the purpose of providing a background for explaining the features of the present invention. Unless there is a particularly clear contrary indication, such reference to external documents should not be construed as admitting that such documents or such information sources are prior art or part of the common general knowledge in the art in any jurisdiction.

[0032] Here, the above and other features, aspects, and advantages of the present invention will be described with reference to the drawings of the preferred embodiments, which are for illustrative purposes and are not intended to limit the present invention.

Brief Description of the Drawings

[0033]

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DETAILED DESCRIPTION OF THE INVENTION

[0034] The interface 20, constructed and configured in accordance with certain features, aspects, and advantages of the present invention, can, for example, but not limited thereto, improve the provision of CPAP therapy. In particular, the closed interface 20 exhibits improved sealing characteristics while being able to limit the pressure exerted on the user's nasal bridge.

[0035] Overview of the System Naturally, the interface 20 can be used with any delivery device used in general respiratory management, for example, with a ventilator. However, the closed interface 20 will be described in relation to its use in a humidified CPAP system. The delivery system can also be in the form of VPAP (Variable Positive Airway Pressure), BiPAP (Bilevel Positive Airway Pressure), or other forms suitable for use in respiratory therapy.

[0036] Naturally, although various features, aspects, and advantages of the patient interface 20 are described in relation to a nasal mask, they can also be used with other interface configurations, for example, but not limited thereto, an oro-nasal mask or a full-face mask that seals around the user's nose and mouth, a mouth mask that seals around the user's mouth, and a nasal pillow or other types of masks that seal below the user's nose.

[0037] Referring to FIG. 1, a humidified continuous positive airway pressure (CPAP) system 22 is shown. The CPAP system 22 in the figure supplies humidified and pressurized gas to the user U through an interface 20 connected to a humidified gas transport path, i.e., an intake conduit 24.

[0038] The intake conduit 24 is connected to an outlet 26 of a humidification chamber 30 configured to contain a certain amount of water 32. The intake conduit 24 may include a heating device (not shown), for example, but not limited thereto, a heating wire or the like. The heating device can reduce condensation of the humidified gas in the intake conduit 24 by heating the wall of the intake conduit 24.

[0039] The humidifying chamber 30 is preferably formed from a plastic material and may have a high thermal conductivity base (e.g., an aluminum base) that comes into direct contact with the heater plate 34 of the humidifier 36. The humidifier 36 uses a controller 40 or the like. The controller may include, for example, but not limited to, a controller based on a microprocessor that executes computer software instructions stored in a related memory.

[0040] The controller 40 receives input commands from a plurality of input sources including a user input interface 42 (e.g., a dial). Through the user input interface 42, a user U can set a predetermined value (e.g., a preset value) for the humidity, temperature, or other characteristics of the gas supplied to the user. The controller 40 may also receive input from other input sources. For example, in the configuration of the figure, temperature and / or flow rate sensors 44, 46 connected through a connector 50 can communicate with the controller 40. In addition to this, a temperature sensor 52 for the heater plate can communicate with the controller.

[0041] In response to a combination of user-set values for humidity or temperature and other inputs that can be input via the user interface 42, the controller 40 determines when and / or how much energy should be supplied to the heater plate 34 to appropriately heat the water 32 housed in the humidifying chamber 30. When a certain amount of water 32 in the humidifying chamber 30 is heated, water vapor begins to fill the space above the water surface of the water 32 in the humidifying chamber 30. The water vapor exits from the outlet 26 of the humidifying chamber 30 and exits along with the flow of gas (e.g., air) supplied from a gas supply device 54 (e.g., a blower) and entering the humidifying chamber 30 from the inlet 56.

[0042] The gas supply device 54 preferably includes an air flow generator 60, which may be a variable speed fan or may include a variable pressure regulator. In the configuration of the figure, the air flow generator 60 includes a variable speed fan. The air flow generator 60 preferably sucks air or other gas from the inlet 62. The air flow generator 60 is controllable, for example, but not limited to, by the controller 64 or by the controller 40. The controller 64 may control the fan speed, regulated pressure or others according to any suitable criteria. For example, the controller 64 may respond to an input from the controller 40 and user set values (e.g., preset values) of pressure and / or fan speed that are settable at the user interface 66 (e.g., a dial).

[0043] Patient interface Referring to FIGS. 2 and 3, the interface 20 generally includes a mask assembly 100. The mask assembly 100 generally includes a frame 102, a seal 104, and a clip 106 used to secure the seal 104 to the frame 102. The mask seal 104 and the clip 106 can be formed separately and joined together, or, depending on the configuration, the mask seal 104 and the clip 106 can be integrated into a single component. In the configuration of the figure, the mask seal 104 is overmolded onto the mask seal clip 106. The connector 108 connects a breathing conduit (not shown) to the mask frame 102.

[0044] Here, referring to FIG. 4, the seal 104 is shown from the back, which is the surface that is placed against and supported by the user's face. The seal 104 includes a facial contact surface 110. As shown in FIG. 4, the facial contact surface 110 preferably includes an edge 112 that at least partially defines an opening 114. In the configuration of the figure, the edge 112 surrounds the opening 114. The opening 114 is designed to receive at least the lower portion and the tip of the user's nose. Preferably, the opening 114 is generally T-shaped, but inverted T-shaped.

[0045] The facial contact surface 110 generally includes a lip surface 120 configured to contact the user's face at a position below the nostrils and above the boundary of the red lips. The facial contact surface 110 also includes two separate cheek surfaces 122 that extend between the lip surface 120 of the facial contact surface 110 and a cross-section 124 of the facial contact surface 110. The cheek surfaces 122 can contact the inner surface of the user's cheek and / or the outer surface of the user's nose. The cross-section 124 extends to cover the user's nose and can connect the two cheek surfaces 122. Other configurations are possible.

[0046] As shown in the cutaway perspective view of FIG. 5, the facial contact surface 110 preferably includes the portion where the cross-section of the material is thinnest within the seal 104. Advantageously, the facial contact surface 110 can be easily deformed to closely adhere to one or more of the undulations of the user's face, such as the upper lip, the inner cheek, the outer nose, and the nasal bridge. Advantageously, since the cross-section of the facial contact surface 110 is thin at the portion covering the user's lips, it has high elasticity, and as a result, the pressure applied to the area above the user's lips is minimized. The seal 104 can be of any suitable configuration. In the illustrated embodiment, the seal 104 is inflatable. Therefore, the facial contact surface 110 is pressed against the user's face by the pressure contained within the seal 104.

[0047] Referring again to FIG. 4, the illustrated seal 104 also includes two thickened panels 130, which are shown in hidden lines. The panels 130 are generally positioned along the upper portion of the cheek surface 122, near the transition from the cheek surface 122 to the cross-section 124. The panels 130 can be formed on the inner surface of the seal 104. The panels 130 represent locally thickened regions, which have been found to enhance the sealing ability of the seal 104. Currently, the panels 130 are thought to increase the lateral pressure against the outer surface of the user's nose, thereby making the pressure from the seal 104 fit more precisely to the shape of the user's nose. In other words, the panels 130 create a pinching effect against the outside of the user's nose, allowing the pressure from the seal 104 to fit more precisely to the shape of the user's nose.

[0048] Referring to FIGS. 5 and 6, the inner surface of the seal 104 further includes at least one thickened strip 132. Although one thickened strip 132 is shown in FIGS. 5 and 6, depending on the configuration, two or more thickened strips or thickened regions can be provided with the desire to realize the characteristics provided by the thickened strip 132 in mind.

[0049] The thickened strip 132 of the figure is positioned along the side wall 134 of the seal 104. The side wall 134 extends forward from the face contact surface 110. The strip 132 preferably includes a larger lower region 136 inside each side of the seal 104 and a thinner connecting rib 140 that extends between the lower regions 136 by wrapping around the upper portion inside the seal 104. When the seal 104 receives pressure from the system 22, the thickened strip 132 helps to reduce the possibility and / or the degree to which the side wall 134 bulges outward. Bulging of the side wall 134 outward can cause unwanted deformation of the seal 104, which may have an adverse effect on the performance of the seal 104.

[0050] Referring to FIG. 5, the side wall 134 preferably includes a thinner proximal portion 142 (i.e., closer to the user's face) and a thinner distal portion 144 (i.e., farther from the user's face). The thinner proximal portion 142 is connected to the thinner distal portion 144 by the thickened strip 132. Preferably, the face contact surface 110 forms a flange that curls inward from the proximal portion 142 of the meat wall. More preferably, the face contact surface 110 is tapered as it moves away from the proximal portion 142 of the side wall 134.

[0051] Continuing to refer to FIG. 5, the distal portion 144 curls inward towards the clip 106 at the shoulder portion 146. Depending on the configuration, the distal portion 144 curls inward towards the edge 150 at the shoulder portion 146. In the configuration of the figure, the edge 150 is overmolded with a part of the clip 106.

[0052] The combination of the shoulder portion and the thin distal portion 144 and the thickened band portion 132 causes the seal 104 to exhibit a bending motion similar to that disclosed in U.S. Provisional Patent Application No. 61 / 476,188, filed Apr. 15, 2011; U.S. Provisional Patent Application No. 61 / 504,295, filed Jul. 4, 2011; U.S. Provisional Patent Application No. 61 / 553,067, filed Oct. 28, 2011; U.S. Provisional Patent Application No. 61 / 553,872, filed Oct. 31, 2011; and International Patent Application No. PCT / IB2012 / 000858, filed Apr. 13, 2012, the entire disclosures of which are incorporated herein by reference. The bending motion is shown somewhat schematically by the dashed line in FIG. 6 and is indicated by the reference letter R. The distal portion of the seal 104 can pivot about the hinge point H, during which the most distal portion curves and protrudes in the region of the shoulder portion, which is shown by the curved portion R indicated by the dashed line in FIG. 6.

[0053] The shorter radius of the thin distal portion 144 and the shoulder portion 146 helps to control buckling and bending of the seal 104. In addition, when pressure is received from the system 22, the internal pressure reduces the likelihood that the seal will become immobile in the curved region, making the bending motion more likely to occur. Further, the hardened band portion 132 extends downwardly toward the hinge point H, but need not extend below the hinge point H. The hardened band portion 132 also functions to limit the extent to which the distal portion 144 can curve and deform. Therefore, the distal portion 144 can curve only until the thickened band portion 132 abuts the edge 150.

[0054] In addition, by positioning the thin proximal portion 142 between the hardened band portion 132 and the facial contact surface 110, the thin proximal portion 142 can deform slightly during wearing of the mask assembly 100. Preferably, the thin proximal portion 142 can deform somewhat more than the distal portion 144. The bending effect improves comfort for the user. Advantageously, the bending effect allows the shape of the seal 104 to vary to accommodate various nasal bridge heights while keeping changes in loading to a minimum.

[0055] Referring to FIG. 7, a graph of test data showing the differences provided by the bending effect is shown. Two masks, namely a prior art nasal mask sold under the trade name Zest(™) by Fisher & Paykel Healthcare, were compared with a prototype mask having a bending effect. The deformation of the mask in the nasal bridge region was shown with respect to the force required to cause the deformation. As shown in the figure, throughout the range of deformation amounts, the prototype mask remained well below 1.5 N, while the prior art mask exceeded 4 N in the same deformation range. Further, as shown in FIG. 7, at any deformation distance, the prototype mask was much lower than the prior art mask. Therefore, for the prototype mask, the total force from the undeformed state to the maximum displacement was about 1 N. Further, the increment of the force received in the last 7 mm (for example, displacement from 13 mm to 20 mm) was less than about 0.3 N.

[0056] Referring to FIGS. 17 - 23, an alternative embodiment of the interface assembly 100 includes a seal 104 having at least one lower wall thickness band 300 in addition to, or instead of, the wall thickness band 132. Except for the at least one lower wall thickness band 300 and other features described hereinafter, the interface assembly 100 of FIGS. 17 - 23 is the same as, or similar to, the interface assembly 100 of FIGS. 2 - 16. Accordingly, the same reference numerals are used to denote the same or corresponding components or features in both embodiments. Referring particularly to FIG. 20, preferably the lower wall thickness band 300 is provided in addition to the wall thickness band 132. The lower wall thickness band 300 is disposed within the lower portion of the seal 104 and preferably below the lower half of the seal 104 and / or below the wall thickness band 132. The wall thickness band 300 is positioned along the lower portion of the side wall 134 of the seal 104 and preferably generally or substantially aligns with the wall thickness band 132 in the front - to - rear direction. However, in other configurations, the bands 132, 300 may be offset from each other in the front - to - rear direction. In other alternative configurations, some or all of the wall thickness band 132 and / or 300 may be disposed generally or substantially in a horizontal plane when the seal 104 is upright (the orientation shown in FIG. 20). In some such configurations, one or more wall thickness bands 132 and / or 300 may extend generally or substantially in the lateral direction of the seal 104. For example, one wall thickness band 132 or 300 may be provided, which, depending on the configuration, may be generally or substantially on the center line of the seal 104. Alternatively, two or more wall thickness bands 132 or 300 may be provided, which may be spaced, for example, above and below the center line of the seal 104. Further, a combination of one or more generally or substantially lateral bands and one or more generally or substantially longitudinal or circumferential bands may be provided.

[0057] The illustrated band 300 preferably includes a larger upper region 302 on the inside of each side of the seal 104 and a thinner connecting rib 304 extending between the larger upper region 302. The upper region 302 and / or connecting rib 304 are preferably similar in shape to the lower region 136 and rib 140 of the band region 132. However, in the illustrated configuration, the band 300 is scaled somewhat smaller than the band 132, corresponding to the lower portion of the seal 104 being somewhat thinner (in the anterior-posterior direction) than the upper portion of the seal 104. Preferably, the band 300 performs substantially the same function as the band 132. For example, the band 300 preferably reduces the likelihood and / or degree to which the sidewall 134 bulges outward, thereby causing the lower portion of the seal 104 to exhibit a bending behavior in a manner similar to or the same as that described above with respect to the band 132.

[0058] Referring now to Figure 8, three cross sections are shown in the lower right portion of the seal 104 of the figure. The lowest cross section, located near the corner of the seal 104 of the figure, is labeled with the reference letter A. A slightly higher cross section is labeled with the reference letter B, and an even higher cross section is labeled with the reference letter C. As shown, the middle cross section B is substantially thicker than the two adjacent cross sections A and C. The three cross sections A, B, and C are relatively close to one another, and the wide variation in thickness allows for better distribution of loads on the user's face.

[0059] Currently, it is considered that the user's face can withstand a greater load or pressure in certain areas compared to other areas. Increasing the thickness of the inner wall 134 allows the force to be better transmitted from the clip 106 to the face contact surface 110 through the side wall 134. Similarly, decreasing the thickness of the side wall 134 reduces the force transmitted between the clip 106 and the face contact surface 110 through the side wall. Depending on the configuration, the user's face is considered to be pressure-tolerant in the upper jaw area just below the zygomatic process. For this reason, the lower corner region 152 includes a thicker region (e.g., Region B). Connecting to the forehead contact point provided by the frame 102, a triangular support portion can be defined between the two lower regions 152 of the seal 104 and the forehead contact point. The triangular support portion provides a stable base on the face, which can assist in resisting dislodgment during use.

[0060] To permanently attach the seal 104 to the clip 106, an overmolding method can be used. Referring to FIG. 9, the clip 106 is shown in a state where the seal 104 is not attached. The clip 106 can be formed of any suitable rigid or semi-rigid material. In one configuration, the clip 106 is formed of a polycarbonate material. Since the seal 104 is preferably formed of a silicone material and the clip 106 is formed of a polycarbonate material, by providing a retaining structure 160 on the clip 106, the seal 104 is fixed to the clip 106 by overmolding. In other words, since the silicone material of the seal 104 generally does not adhere to the polycarbonate material of the clip 106, the seal 104 is held on the clip 106 by securely locking the silicone material around the elements of the retaining structure 160.

[0061] The retaining structure 160 of the clip 106 is formed at the proximal end 162 of the clip 106. The retaining structure 160 in the figure is formed integrally with the clip 106, but these two can also be formed separately and joined together in any suitable way. However, the integrated structure improves manufacturability and the finished product is more durable.

[0062] The retaining structure 160 includes a plurality of struts 164 that define a plurality of slots 166. Preferably, the struts 164 are spaced along a circumferential surface 168 that defines an opening 170 at the proximal end of the clip 106. More preferably, the struts 164 are spaced substantially evenly along the circumferential surface 168. Even more preferably, the struts 164 are spaced along the circumferential surface 168 such that the ratio of the struts 164 to the intervening slots 166 is about 1:2. This 1:2 ratio has been found to maximize the connection strength between the seal 104 and the clip 106.

[0063] Continuing to refer to FIGS. 9 and 10, the retaining structure 160 preferably includes at least one distal surface 172 and at least one proximal surface 174, which are generally parallel to each other. In the illustrated configuration, the at least one distal surface 172 includes a ring-shaped surface that surrounds the proximal end 162 of the clip 106, while the at least one proximal surface 174 includes the plurality of ends of the struts 164. The parallel surfaces 172, 174 serve to minimize compression and resulting distortion due to the clamping force received during the overmolding process.

[0064] Further, as shown in FIGS. 9 and 10, the slots 166 are generally surrounded by a ring 176. In the illustrated configuration, the ring 176 surrounds the outside of the struts 164 at the distal ends of the struts 164. Other configurations are also possible. However, the illustrated configuration provides an easy-to-manufacture configuration.

[0065] Referring to FIG. 10, the distal end 180 of the clip 106 is configured to be attached to the frame 102. Preferably, the clip 106 is easy to attach to and remove from the frame 102, facilitating cleaning of the clip 106 and the seal 104 attached thereto. More preferably, the distal portion 180 is configured to be in a sealed state with the surface of the frame 102. Even more preferably, the distal surface 182 is configured to be in contact with the surface of the frame 102.

[0066] Continuing to refer to FIG. 10, the distal portion 180 of the clip 106 includes one or more depressions 184. Preferably, the depressions 184 are also designed to closely adhere to the frame 102. In particular, the thin frame 102 includes one or more protrusions 190 that extend rearwardly towards the clip 106. Advantageously, these protrusions fit into the depressions 184 of the clip 106 to provide a snug fit and to thin the assembly 100.

[0067] Referring to FIGS. 3 and 11, the frame 102 and the clip 106 are preferably interconnected in an airtight, i.e., sealed, relationship. In the illustrated configuration, the frame 102 includes a mounting boss 192 that extends towards the clip 106. The mounting boss 192 includes an outer surface 194 around which the inner surface 196 of the distal end 180 of the clip 106 slides. Preferably, the connection between the boss 192 and the distal end 180 of the clip 106 is a tapered fit. More preferably, the connection includes a medical taper of 1:40, which provides a mating surface that minimizes leakage between the two components. Even more preferably, the tapered connection includes an interference fit with a travel distance of 2 mm when measured from the back surface 200 of the frame 102 to the distal surface 182 of the clip 106. The outer surface 194 of the illustrated boss 192 and the inner surface 196 of the illustrated distal end 180 are generally cylindrical, although other shapes are possible.

[0068] Referring to FIGS. 17 - 23, the alternative interface assembly 100 includes an improvement to the detachable mounting configuration between the clip 106 and the frame 102. In particular, the mounting boss 192 includes intermittent, i.e., discontinuous, walls along its circumference. Preferably, the proximal end (i.e., the end closest to the user) includes at least one, preferably a plurality of recesses or notches 310, which extend towards the distal end of the mounting boss 192 and facilitate connecting the clip 106 to the frame 102. In particular, due to the notches 310, while assembling the clip 106 to the frame 102, the wall portion of the boss 192 between the notches 310 bends inwards, effectively reducing the diameter of the mounting boss 192. In the illustrated configuration, the notches 310 are generally or substantially triangular, and four notches 310 are provided. However, the notches 310 may be of other shapes (e.g., generally or substantially rectangular, square, trapezoidal, semi - circular) and numbers (e.g., 2, 3, 5, 6 or more). In addition to this, preferably, the notches 310 are unevenly spaced along the circumference of the mounting boss 192. In the illustrated configuration, the notches 310 are arranged as an upper pair and a lower pair, and the circumferential distance between the individual notches 310 of the upper and lower pairs is smaller than the circumferential distance between one of the notches 310 of the upper pair and the adjacent notch 310 of the lower pair. Preferably, in other respects, the mounting boss 192 of the interface assembly 100 in FIGS. 17 - 23 is similar to the mounting boss 192 of the interface assembly 100 in FIGS. 2 - 16, including, for example, a tapered fit.

[0069] The clip 106 and the frame 102 of FIGS. 17 - 23 may preferably also include an interference fit or an interlock configuration 320, which serves to hold the connection between the clip 106 and the frame 102 and / or increases the force required to separate the clip 106 from the frame 102. In such a configuration, preferably, the likelihood that the clip 106 and the frame 102 will inadvertently or undesirably separate is reduced. Preferably, one of the clip 106 and the frame 102 includes at least one protrusion, and the other of the clip 106 and the frame 102 includes at least one recess sized and shaped to receive the protrusion. In the illustrated configuration, the clip 106 includes a pair of protrusions 322 and the frame 102 includes a complementary pair of recesses 324, although this configuration can be reversed. Preferably, the protrusions 322 are disposed above and below the inner surface 196 of the distal end 180 of the clip 106, and the recesses 324 are disposed above and below the outer surface 194 of the mounting boss 192 of the frame 102. In the illustrated configuration, the protrusions 322 and the recesses 324 are in diametrically opposed positions, each being circumferentially long on their respective surfaces 196 and 194, maximizing the length of the interference fit or interlock surface, thereby preventing separation of the frame 102 and the clip 106 and tending to minimize the axial length.

[0070] Preferably, the frame 102 of the interface assembly 100 of FIGS. 17-23 includes at least one recess 330, into which the distal portion 180 of the clip 106 fits during use. In the illustrated configuration, the frame 102 includes a pair of recesses 330, which are positioned on either side of the mounting boss 192 and interact with the clip 106 to prevent or inhibit rotation of the clip 106 with respect to the frame 102. Preferably, the lower end of the recess 330 is positioned near the mounting boss 192, and the upper end of the recess 330 extends laterally outwardly and laterally away from the mounting boss 192. Compared to the clip 106 of FIGS. 2-16, the wall thickness of at least a portion of the circumference of the distal portion 180 of the clip 106 of FIGS. 17-23 is thinner. The clip 106 of FIGS. 17-23 transitions to a thicker portion at the shoulder 332, which defines a surface 334 facing in the distal direction. Preferably, in addition to the distal surface 182 contacting the frame 102, the surface 334 contacts the end surface 336 of the recess 330 as shown in FIG. 19, which helps to seal between the clip 106 and the frame 102. In addition to this, the contact between the surface 334 and the end surface 336 can define a complete connection position between the clip 106 and the frame 102. The shoulder 332 can be defined by the recess 184 of the clip 106 and thus extends over the same extent as the recess 184. The engagement of the recess 184 and the recess 330 can prevent or inhibit rotation of the clip 106 with respect to the frame 102. In other configurations, the shoulder 332 can surround a longer distance than the recess 184, or one shoulder 332 can surround the entire distal portion 180.

[0071] Referring to FIGS. 3 and 11, the boss 192 preferably surrounds an inner surface 202 that defines a socket for the ball connection 204 with the connector 108. In the illustrated configuration, the connector 108 generally includes an L-shaped tube 206 and a swivel 210. The swivel 210 can be used to connect to the intake conduit 24 or other breathing tube. Preferably, the L-shaped tube 206 is connected to the frame 102 by a joint defined by the ball 204 and the socket 202, while the swivel 210 is connected to the L-shaped tube by a cantilevered projection configuration 212.

[0072] According to the joint defined by the ball 204 and the socket 202, preferably, a limited range of pivotal movement is possible. Depending on the configuration, the ball 204 can pivot up to approximately 30 degrees with respect to the socket 202. Other ranges of pivotal movement can be defined as desired.

[0073] In the configuration of the figure, the ball 204 is pushed into the socket 202 of the frame 102 from the side of the frame 102 having the back surface 202. In other words, the L-shaped tube 206 is connected through the socket and the ball 204 is pushed into and engaged with the socket 202. In such a configuration, the L-shaped tube 206 is less likely to be easily removed from the frame 102 by the user.

[0074] On the other hand, the swivel 210 is designed to be easily removable from the L-shaped tube 206. Preferably, the swivel 210 can rotate 360 degrees with respect to the L-shaped tube 206 about its axis, and the swivel 210 can be axially removed from the L-shaped tube 206 with a force of only about 30 N. Further, the connection between the L-shaped tube 206 and the swivel 210 is preferably designed to reduce leakage at the connection. In the configuration of the figure, the leakage is maintained at about 0.05 to about 0.4 L / min at 10 cmH2O.

[0075] Referring to FIG. 3, the distal end 214 of the L-shaped tube 206 preferably includes two or more notch regions or depressions 216. The depressions 216 can be of any suitable shape. In the configuration of the figure, the depressions 216 have a semi-circular shape, which extends upward into the distal end 214 of the L-shaped tube 206. The distal end 214 of the L-shaped tube 206 also includes at least one projection 220, preferably two or more projections 220. Preferably, each of the projections 220 extends along an arc of about 70 degrees. More preferably, each of the projections 220 is generally centered between the two depressions 216, and each of the projections 220 extends around the outer surface of the distal end 214 of the L-shaped tube 206 for about 70 degrees.

[0076] The swivel 210 preferably has a generally cylindrical shape. As shown in FIG. 3, the swivel 210 has an inwardly extending rib 222. The rib 222 preferably extends around the entire inner circumference. Depending on the configuration, the rib 222 may have an interruption. However, preferably, the rib 222 does not have an interruption large enough to accommodate the entire protrusion 220, whereby the rib 222 and the protrusion 220 cooperate to hold the swivel 210 in a state attached around the distal end 214 of the L-shaped tube 206. When assembling the swivel 210 to the L-shaped tube 206, the recess 216 causes the protrusion 220 to bend inwardly, whereby the protrusion 220 slides along the rib 222 and then snaps back outwardly to secure the protrusion 220 under the rib 222. For this purpose, the distance from the shoulder portion 224 (see FIG. 12) to the apex of the protrusion 220 (indicated by X in FIG. 12) is substantially equal to or slightly greater than the distance from the proximal end 226 of the swivel (see FIG. 3) to the lower edge of the rib 222.

[0077] Referring now to FIG. 12, the L-shaped tube 206 preferably includes a plurality of vent holes 230 formed integrally. The vent holes 230 can be formed in a separate insert fixed to the L-shaped tube 206, but forming the vent holes 230 integrally results in a more aesthetically pleasing appearance and simplifies the assembly of the interface assembly 100. The vent holes are preferably formed in the surface of the L-shaped tube 206, i.e., on the outer side of the bend from the proximal end with the ball 204 towards the distal end 214. Other configurations are possible.

[0078] Referring to FIG. 13, the vent hole 230 preferably comprises a configuration consisting of two parts. One or more proximal ends 232 of the vent hole 230 form a conical depression leading to the inner surface 234. In other words, one or more proximal ends 232 of the vent hole 230 include a dish-shaped surface. One or more distal ends 236 of the vent hole 230 include a trumpet-shaped surface. In other words, one or more distal ends of the vent hole 230 include a part of the shape of an hourglass. Preferably, the conical shape of the proximal end 232 and the trumpet shape of the distal end 236 are generally axially aligned and characterized by a smooth transition between the two shapes. More preferably, all or substantially all of the vent holes 230 have this configuration. Even more preferably, all or substantially all of the vent holes 230 are generally parallel to each other.

[0079] Continuing to refer to FIG. 13, the proximal end 232 of the vent hole 230 preferably defines a conical surface which, when viewed in cross-section, is substantially parallel to the axial center line CL of the proximal end of the L-shaped tube. In other words, the axial center line CL is generally related to the direction in which the die or insert is inserted and removed during manufacturing. More preferably, when viewed in cross-section, the proximal end 232 of the vent hole has at least one side wall (when viewed in cross-section) which, when viewed in cross-section, generally extends parallel (see reference line PL) or is generally oblique with respect to the parallel direction and deviates from the parallel direction as it moves in the proximal direction (i.e., as the proximal end 232 widens). Thus, the proximal ends 232 of all or substantially all of the vent holes 230 can be formed from one insert, and at the same time, the insert can be easily withdrawn. Depending on the configuration, the insert or die can be withdrawn from the distal end 214 of the L-shaped tube, and the surface of the vent hole 230 is appropriately configured to match such an insertion and withdrawal direction of the insert.

[0080] Preferably, the wall thickness (i.e., the distance between the inner surface 234 and the outer surface 240) is about 1.5 mm. In such a configuration, the proximal end 232 (i.e., the conical portion in FIG. 14) is about 0.5 mm, while the distal end 236 (i.e., the trumpet-shaped portion in FIG. 14) is about 1.0 mm. Other dimensions and configurations are possible. The configuration of the figure is known to appropriately reduce the noise level associated with the air flow exiting the ventilation hole 230.

[0081] Referring again to FIG. 2, it is shown that one or more headgear clips 250 are attached to the frame 102. In the configuration of the figure, two headgear clips 250 are fixed to the frame 102. The frame 102 generally includes ears 252, which are associated with each headgear clip 250. The ears 252 preferably extend generally laterally outward from the inner surface 202 that defines a socket for the L-shaped tube 206.

[0082] As shown in FIG. 15, each of the ears 252 includes a strut 254, while each of the clips 250 includes a hook 256. The hook 256 and the strut 254 provide a configuration that can be easily connected and disconnected. Preferably, the clip 250 is symmetric, so that one clip can be used on both the left and right sides of the frame 102.

[0083] Depending on the configuration, a slight interference can be provided between the hook 256 and the strut 254 to reduce the possibility that the hook 256 accidentally disengages during use. Depending on the configuration, the hook 256 and the strut 254 can be shaped such that they are easier to remove from the hook 256 at a specific angular orientation around the strut 254 (for example, by pivoting the hook 256 away from the seal 106 around the strut 254, it can be made easier to remove from the shape of the strut 254). Further, since the hook 256 is pivotable with respect to the strut 254, the angular orientation of the clip 250 with respect to the frame 102 can be changed to make it easier to accommodate differences in head shape.

[0084] Each clip 250 includes a slot 260 defined through a main body 262 of the clip 250. The slot 260 is sized and configured to receive a lower strap 264 of the headgear assembly 266. Preferably, the lower strap 264 is passed through the slot 260 and folded back. More preferably, the lower strap 264 includes a hook-and-loop fastening portion, whereby the lower strap 264 is passed through the slot 260, folded back, and secured to itself. Other configurations may also be used.

[0085] The headgear assembly 266 also includes a pair of uppermost straps 270 and a pair of upper straps 272. The uppermost straps 270, upper straps 272, and lower strap 264 preferably converge at a main body 274. Further, each of the straps 264, 270, 272 preferably has a tab 276 that forms a part of a hook-and-loop fastening portion at its end. The tab 276 can be ultrasonically welded to the ends of the straps 264, 270, 272.

[0086] The straps 264, 270, 272 and the body 274 together define the headgear assembly 266. Depending on the configuration, the headgear assembly has a three-layer structure, which includes layers formed of Lycra, foam, and UBL (unbroken loop) material. Advantageously, the UBL material provides a surface to which the tab 276 can be adhered. Depending on the configuration, the thickness of the three-layer structure is about 4 mm.

[0087] The uppermost strap 270 can be connected to a buckle, which is generally positioned at the top of the head. When combined with the buckle, the uppermost strap 270 generally defines a crown strap. The upper stop 272 is passed through a slot 280 formed in the T-joint portion of the frame 102 (see FIG. 2), and the lower strap 264 is passed through the clip 250 as described above. Depending on the configuration, the slot 280 in the T-joint portion of the frame 102 has a split in the material defining the slot 280, whereby the loop defined by the upper strap 272 can be attached to and detached from the frame 102, at which time the tab 276 need not be separated from the portion of the strap 272 where the tab 276 is attached by a hook-and-loop fastener.

[0088] In the alternative interface configuration 100 of FIGS. 17 - 23, the slot 280 defines an opening 340 at its lower end and has a closed end 342 at its upper end. In particular, the central portion 344 of the frame 102 extends along the inside of the slot 280 and transitions to an upper portion 346 that defines the closed end 342 of the slot 280. The outer portion 350 extends along the outside of the slot 280 and has a tab 352 that extends inwardly at its end, which extends towards the central portion 344 but ends before reaching it, and the opening 340 of the slot 280 is defined. The upper closed end 342 prevents the upper strap 272 from coming off the frame 102 in an upward direction, and the tab 352 prevents the upper strap 272 from coming off the frame 102 unintentionally or undesirably in a downward direction.

[0089] The body 274 is preferably defined as a region that interconnects with various straps 264, 270, 272 and is tapered (narrower towards the straps 264, 270, 272), serving as a region to reinforce the intersection of the straps 264, 270, 272. The body 274 can be configured to be positioned below the external occipital protuberance of the parietal bone. Such positioning when worn by the user reduces the movement of the headgear assembly 266 when the user turns their neck. Further, when the straps are attached, a three-dimensional configuration is obtained by the generally linear strap configuration. In other words, as shown in FIG. 16, the lower strap 264 extends substantially linearly from the body 274. Therefore, generally, the center line LS extends along each of the lower straps 264. Similarly, as shown in FIG. 16, the upper strap 272 also extends substantially linearly from the body 274. Therefore, generally, the center line US extends along both upper straps 272. In the configuration of the figure, the center line US does not intersect the entire body 274. In other words, a part of the body is offset from and does not intersect the center line US. Depending on the configuration, generally, the center line LS is positioned at an angle with respect to the center line US. Preferably, this angle is between about 20 degrees and about 50 degrees.

[0090] In the configuration of the figure, the center line LS of the lower strap intersects at a position between the body 274 and the center line US of the upper strap. Depending on the configuration, the center line LS of the lower strap intersects on the same side of the center line US of the upper strap where the lower strap 264 is positioned. Depending on the configuration, the intersection point of the center line LS of the lower strap is offset by a distance N from the center line US of the upper strap. Preferably, the distance N is about 23 mm. Depending on the configuration, the center line LS of the lower strap intersects the center line US of the upper strap at a position separated by a distance M. Preferably, the distance M is about 43 mm. Other configurations are also possible.

[0091] Although the present invention has been described with respect to specific embodiments, other embodiments that will be apparent to those skilled in the art are also within the scope of the present invention. Therefore, various changes and improvements may be made without departing from the spirit and scope of the present invention. For example, the positions of various components may be changed as desired. Further, not all of the features, aspects, and advantages are necessarily required for the implementation of the present invention. Accordingly, the scope of the present invention is to be defined solely by the following claims.

Claims

Claim 1 A seal member for an interface assembly, wherein the seal member includes a face contact surface, the face contact surface includes an edge that at least partially defines an opening, the face contact surface also includes a first cheek surface and a second cheek surface, the first cheek surface includes a first wall thickness portion, and the second cheek surface includes a second wall thickness portion. Claim 2 The seal member according to claim 1, wherein the first and second wall thickness portions are formed on an inner surface of the seal member. Claim 3 The seal member according to claim 1, wherein a distal portion of the seal member is overmolded onto a clip member. Claim 4 The seal member according to claim 3, wherein the clip includes a feature that receives a complementary feature of an interface frame. Claim 5 The seal member according to claim 3, wherein the clip member is tapered in a distal direction. Claim 6 A seal member for an interface assembly, wherein the seal member includes a face contact surface, the face contact surface includes an edge that at least partially defines an opening, the face contact surface also includes an upper lip contact surface, a first cheek surface, and a second cheek surface, a side wall extends in a distal direction of the face contact surface, the side wall includes a first lower corner near a transition portion from the upper lip surface to the first cheek surface, the side wall includes a second lower corner near a transition portion from the upper lip surface to the second cheek surface, and a cross section of the first lower corner and the second lower corner is thicker than a portion of the side wall disposed above the first lower corner and the second lower corner in a longitudinal direction. Claim 7 The seal member according to claim 6, wherein a distal portion of the seal member is overmolded onto a clip member. Claim 8 The seal member according to claim 7, wherein the clip includes a feature that receives a complementary feature of an interface frame. Claim 9 The seal member according to claim 7, wherein the clip member is tapered in a distal direction. Claim 10 In a seal member for an interface assembly, the seal member includes a face contact surface, the face contact surface includes an edge that at least partially defines an opening, the face contact surface also includes an upper lip contact surface, a first cheek surface, and a second cheek surface, side walls extend distally from the face contact surface, and the side walls include a first thickened strip extending along a portion corresponding to the first cheek surface and a second thickened strip extending along a portion corresponding to the second cheek surface.

11. The seal member according to claim 10, wherein a distal portion of the seal member is overmolded onto a clip member.

12. The seal member according to claim 11, wherein the clip includes a feature that receives a complementary feature of an interface frame.

13. The seal member according to claim 11, wherein the clip member is tapered distally.

14. The seal member according to claim 10, wherein a cross-section of the side wall of the seal member distal to the first and second thickened strips is thicker than a cross-section of the side wall proximal to the first and second thickened strips.

15. The seal member according to claim 14, wherein a distal portion of the seal member is overmolded onto a clip member.

16. The seal member according to claim 15, wherein the clip includes a feature that receives a complementary feature of an interface frame.

17. The seal member according to claim 15, wherein the clip member is tapered distally.

18. In a headgear for an interface assembly, the headgear includes a body, a first lower strap and a second lower strap extending from the body, a first upper strap and a second upper strap extending from the body, the first lower strap includes a centerline of the first lower strap, the second lower strap includes a centerline of the second lower strap, the first upper strap includes a centerline of the first upper strap, and the centerlines of the first and second lower straps intersect each other and then intersect the centerline of the first upper strap.

19. The headgear according to claim 18, wherein the second upper strap includes a centerline of the second upper strap, and the centerline of the first upper strap corresponds to the centerline of the second upper strap.

20. The intersection of the center line of the first lower strap and the center line of the second lower strap is offset by a distance of about 23 mm from the center line of the first upper strap, the headgear according to claim 18.

21. The center line of the first lower strap intersects the center line of the first upper strap at a position about 43 mm from the position where the center line of the second lower strap intersects the center line of the first upper strap, the headgear according to claim 18.

22. The center line of the first upper strap and the center line of the second upper strap are correlated with each other and do not intersect the entire body of the headgear, the headgear according to claim 18.

23. The center line of the first lower strap extends at an angle with respect to the center line of the first upper strap, and the angle is about 20 degrees to about 50 degrees, the headgear according to claim 18.

24. In the L-shaped tube used for the interface assembly, the L-shaped tube includes a body having a proximal end and a distal end, the proximal end and the distal end form an angle with respect to each other, a bent portion is defined at a transition portion from the proximal end to the distal end, the bent portion includes a plurality of ventilation holes, and the plurality of ventilation holes are integrally formed with the body of the L-shaped tube.

25. In the L-shaped tube used for the interface assembly, the L-shaped tube includes a body having a proximal end and a distal end, the proximal end and the distal end form an angle with respect to each other, a bent portion is defined at a transition portion from the proximal end to the distal end, the bent portion includes a plurality of ventilation holes, and one or more of the ventilation holes include a conical first portion and a trumpet-shaped second portion.

26. The conical first portion is an inner portion, and the trumpet-shaped second portion is an outer portion, the L-shaped tube according to claim 25.

27. The ventilation holes are integrally formed with the body, the L-shaped tube according to claim 25.

28. In the interface assembly, including a frame and a seal detachably connected to the frame, the interface assembly wherein the seal is configured according to any one of claims 1 to 17.

29. An interface assembly including a frame and a headgear detachably connected to the frame, wherein the headgear is configured according to any one of claims 18 to 24.

30. An interface assembly including a frame and a conduit connector connected to the frame, wherein the conduit connector includes an L-shaped tube, and the L-shaped tube is configured according to any one of claims 25 to 27.

31. An interface assembly including a frame, a seal and a headgear detachably connected to the frame, wherein the seal is configured according to any one of claims 1 to 17, and the headgear is configured according to any one of claims 18 to 24.

32. An interface assembly including a frame, a seal connected to the frame, and a conduit connector connected to the frame, wherein the conduit connector includes an L-shaped tube, the seal is configured according to any one of claims 1 to 17, and the L-shaped tube is configured according to any one of claims 25 to 27.

33. An interface assembly including a frame, a headgear connected to the frame, and a conduit connector connected to the frame, wherein the conduit connector includes an L-shaped tube, the headgear is configured according to any one of claims 18 to 24, and the L-shaped tube is configured according to any one of claims 25 to 27.

34. An interface assembly including a frame, a seal and a headgear connected to the frame, and a conduit connector connected to the frame and including an L-shaped tube, wherein the seal is configured according to any one of claims 1 to 17, the headgear is configured according to any one of claims 18 to 24, and the L-shaped tube is configured according to any one of claims 25 to 27.

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