CN1784250A - mask system - Google Patents

Abstract

The invention relates to a mask system for treating sleep disordered breathing comprising headgear (20), a shell/cushion (30) having a channel (524) adjacent a front aperture (30.3), a frame (40), an elbow (50) having at least one undercut (50.2) on a proximal end, and a clasp (60) having a rear flange (64) and a front flange (66), the rear flange (64) for retainably inserting into the channel (524) of the shell/cushion (30) and the front flange (66) for retainably engaging the at least one undercut (50.2) of the elbow (50).

Description

mask system

technical field

The present invention relates to a mask system for positive pressure ventilation of sleep-disordered breathing. In particular, the present invention relates to a low cost mask system.

Background technique

Obstructive sleep apnea (OSA) is a condition characterized by repeated obstruction of the upper airway, often leading to oxygen desaturation and arousal from sleep. The typical daytime presentation is extreme sleepiness, but other symptoms such as non-restorative sleep, lack of concentration, and fatigue are commonly reported (Sleep-Related Breathing Disorders in Adults - AASM Task Force, Sleep 22, 1999).

Sullivan in US Patent 4,944,310 teaches the use of nasal continuous positive airway pressure (CPAP) to treat OSA. Other developments are taught in US Patents 5,704,345, 6,029,665 and 6,363,933.

Nasal CPAP systems typically include a flow generator, air tubing, and a patient interface (eg, a nasal mask). The air flow generator provides a certain amount of positive pressure air.

Various mask systems are known for the treatment of sleep-disordered breathing (SDB), such as the BUBBLE(R) mask, MIRAGE(R), ULTRA MIRAGE(R) and MIRAGE VISTA ^(TM) masks, all manufactured by ResMed Limited.

Another known mask is the Weinmann nasal mask.

Mask systems typically include a headgear and mask assembly. The headgear is used to hold and position the mask on the patient's face. Mask devices typically include at least a hard shell and a soft face-contacting cushion. Some mask assemblies also include elbows, vents, headgear clips, and forehead rests.

A number of pads have been patented, see for example US Patents 6,112,746, 6,357,441 and 6,513,526. Also patented are forehead supports (see US Patents 6,119,693; 6,463,931; 6,520,182; 6,532,961), headgear connectors (US Patent 6,374,826), mask ports (US Patent 6,439,230), and cushion clips (US Patent 6,412,487). The contents of all of these patents are hereby incorporated by reference.

Another known mask device is the PAPILLION ^™ mask manufactured by MAP, Germany, Austrian Design Registration #50770 and #50771 (and US Design Patent D484,237 and Australian Design Registration Application 2153/2002).

Since patients must wear sleep-disordered breathing mask systems for several hours each night while they sleep, designers strive to make them comfortable. In particular, they have endeavored to eliminate the mask system as a source of decubitus ulcers on the patient's face.

A problem that can arise in prior art mask systems is that there can be drag forces from the tubing which, when transmitted through the elbow, can break the seal of the cushion to the face.

A solution to this problem is found in US 6,039,044. An aspect of the present invention is to provide at least another solution to this problem.

A challenge with some prior art mask assemblies is that those mask assemblies that achieve a clinically effective seal while still being comfortable for the patient to wear at home each night can be expensive to manufacture. Headgear can be a significant portion of the manufacturing cost of a mask system. Manufacturing costs are passed on to the user, which results in a more expensive mask arrangement for the patient. This may in turn mean that fewer patients can afford the treatment. It may also mean a tendency for clinics and hospitals to reuse masks among numerous patients. Reuse of face coverings from different patients is not recommended unless the entire health system properly manages cross-contamination. Often, especially in hospitals where respiratory diseases such as SARS occur, it is desirable to have a mask system that is cheap enough to be disposable.

Yet another aspect of the present invention is to provide a low-cost mask device for treating sleep-disordered breathing.

Yet another aspect of the present invention is to provide a disposable mask device for treating sleep-disordered breathing.

Contents of the invention

Throughout the specification and claims of the present invention, the combination of shell and cushion will hereinafter be referred to as "shell/pad". This is done for convenience, and wherever the expression "shell/pad" appears, it should be understood to mean the combined shell and pad.

According to a first aspect of the present invention there is provided a comfortable low cost mask system comprising a headgear, combined shell/cushion, frame, elbow and buckle.

According to another aspect of the present invention, a low cost headgear is provided.

According to yet another aspect of the present invention, a comfortable shell/cushion is provided that reduces the tendency to create pressure points on the patient's face.

In one embodiment, a mask system for treating sleep-disordered breathing comprises a headgear, a shell/cushion comprising a channel adjacent to the front aperture, a frame, an elbow comprising at least one undercut on the proximal end, and a rear a retaining ring of the flange and the front flange, said rear flange is adapted to be retainable inserted in the channel of the shell/liner, and the front flange is adapted to be retainable with the at least one undercut of the elbow ground engagement.

Adjacent to the channel of the shell/liner there may be provided a thin walled part which is adapted to tear apart when the elbow is removed.

The construction of the elbow can help prevent disengagement of the hole from the clasp during normal use.

When the elbow is separated from the mask, the elbow may have a cylindrical outlet.

The shell/gasket may include an annular flange which engages the edge of the outlet when the annular flange is assembled with the elbow or said web, thereby suitably aligning the outlet with said flange. Close edge.

In another embodiment, a mask system for treating sleep-disordered breathing includes a headgear, a frame, and a shell/cushion, the shell/cushion including a channel for receiving the frame formed by a front flange and a rear flange, the front flange The rim extends 75% to 100% around the perimeter of the shell/cushion, wherein the frame is adapted to be detachably inserted into a channel of the shell/liner receiving the frame.

Such mask systems may include at least a nasal bridge region of the shell/cushion adapted to contact the nasal bridge region of a patient. The posterior flange of the nasal bridge region may be 1 mm to 3 mm thick. The rear flange may be about 2 mm thick.

In yet another embodiment, a connection is provided for attaching a mask to a conduit that delivers airflow to said mask. The connector includes an inlet and an outlet and a channel wall for conveying the gas flow between them, the connector includes a vent wall extending from the channel wall between the outlet and the inlet adjacent the outlet, the vent wall comprising at least one hole through.

The connector can be made integrally with the mask. Alternatively, the connectors can be made separately from the mask, which can then be joined or attached to the mask.

The connection can be made integrally with the pipe. Alternatively, the connectors can be made separately from the pipes and then joined or affixed to the pipes.

The connection can be made so that the outlet is at any suitable angle to the inlet. The outlet preferably forms an angle of 90°-180° with the inlet. The connection can be a 90° elbow.

The connector may include connection structure to connect the connector to the mask. The attachment structure may include at least one snap-fit undercut to engage a companion.

The connecting structure removably connects the connecting member to the mask.

The connecting structure may comprise a movable part on which the snap-fit undercut is formed, the movable part allowing the undercut to disengage from the flange.

The connecting structure can allow the connecting member to rotate relative to the mask.

The connector may include a Luer port through the channel wall, which may be at the side and/or in front of said connector.

The vent walls may be at an oblique angle to the airflow. The angle is preferably 25° to 155°.

The connector may include a groove on its outer surface, the groove having a wall portion extending from the outer surface of the vent wall. The wall portion may diverge in a direction away from the vent wall.

In yet another embodiment, a mask system for treating sleep-disordered breathing comprises: a shell/cushion having inner and outer surfaces; a flange extending from the outer surface and surrounding the shell/cushion; the mask having an exoskeleton frame, the outer The shape of the skeleton frame substantially matches the contour of the flange so that the frame can be positioned adjacent to the flange when the shell/cushion is shaped for patient use; and structure to retain said flange on the frame.

The means for retaining the flange to the frame may include one or more holes through the flange.

Rivets or other fasteners can pass through the holes to hold the flanges against the frame.

The frame can be attached to the headgear to position the mask on the patient's head.

The frame may include a connecting member connected to the frame, the connecting member cooperating with the frame to sandwich the flange between said connecting member and the frame. The connecting member may be hinged to the frame, or connected to the frame by a flexible member.

A second frame may be provided whose shape substantially matches the contour of the flange so as to sandwich said flange between the first frame and the second frame.

The second frame, the flange and the first ring member may be fixed together by rivets and/or fasteners or the like.

The second frame may include a rivet extending therefrom that may pass through the flange and the first frame. Alternatively, the first frame may include a rivet extending therefrom that may pass through the flange and the second frame. Another option is for the flange to include a first set of rivets extending forward and a second set of rivets extending rearward, the first set of rivets driven into holes through the first frame and the second set of rivets driven through the first frame. In the hole of the second frame.

Rivets can deform at their free ends, or the holes they penetrate can deform.

The rivet may include an undercut so that the undercut can pass through the hole to secure the components together.

Another embodiment of the present invention provides a mask system comprising a headgear and a mask as described above. Such a mask system may include connectors as described above.

These variations are set forth in, or are apparent from, the following detailed description of the preferred embodiments.

Description of drawings

Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 shows a perspective view of a mask system according to an embodiment of the present invention;

Figure 2 shows a front perspective view of a mask assembly similar to that used in the system of Figure 1, but with a different shell/cushion;

Figure 2A shows a front view of the mask assembly of Figure 2;

Figure 3 shows a side view of the mask assembly of Figure 2;

Figure 4 shows a rear view of the mask assembly of Figure 2;

Figure 5 shows a bottom view of the mask assembly of Figure 2;

Figure 6 shows a top view of the mask assembly of Figure 2;

Figure 7 shows an exploded view of the mask assembly of Figure 2;

Figure 8 shows a cross-section of the mask device of Figure 2;

Figure 9 shows yet another cross-section of the mask assembly of Figure 2 superimposed on top of the side view;

Figure 10 shows a front perspective view of another mask assembly with the same shell/cushion used in Figure 2, but with a different frame;

Figure 11 shows an exploded view of another mask assembly close to a patient's face, with a frame similar to that used in Figure 10, but with a shell/cushion similar to that used in Figures 1 and 7;

Figure 12 shows a side view of the mask assembly of Figure 11 including the disposable headgear in use;

Figure 13 illustrates a front view of the three-point frame used in the mask device of Figure 2;

Figure 14 illustrates a cross-section of the frame of Figure 13 through line XIV-XIV;

Figure 15 illustrates a right side view of the frame of Figure 13;

Figure 16 illustrates a top view of the frame of Figure 13;

Figure 17 illustrates a bottom view of the frame of Figure 13;

Figure 18 illustrates a cross-section showing detail Z of Figure 14;

Figure 19 illustrates a left-hand side perspective view of the frame of Figure 13;

Figure 20 illustrates a right hand side perspective view of the frame of Figure 13;

Figure 21 illustrates a front view of the five-point frame used in the mask assemblies of Figures 10 and 11;

Figure 22 illustrates the cross-section of the frame of Figure 21 through line XXIII-XXIII;

Figure 23 illustrates a left side view of the frame of Figure 21;

Figure 24 illustrates a bottom view of the frame of Figure 21;

Figure 25 illustrates a plan view of the frame of Figure 21;

Figure 26 illustrates a front view of the clasp;

Figure 27 illustrates the cross-section of the clasp of Figure 26 through line XXVII-XXVII;

Figure 28 illustrates a side view of the clasp of Figure 26;

Figure 29 illustrates a perspective view of the clasp of Figure 26;

Figure 30 illustrates a front view of a connector or elbow;

Figure 31 illustrates a right side view of the elbow of Figure 30;

Figure 32 illustrates the cross section of the elbow of Figure 30 passing through the line XXXII-XXXII;

Figure 33 illustrates the cross section of the elbow of Figure 30 passing through the line XXXIII-XXXIII;

Figure 34 illustrates a plan view of the elbow of Figure 30;

Figure 35A illustrates a lower rear perspective view of the elbow of Figure 30;

Figure 35B illustrates an upper front perspective view of the elbow of Figure 30;

Figure 36 illustrates a detail X of the cross-section of Figure 33;

Figure 37 illustrates a detail Z of the cross-section of Figure 32;

Figure 38 illustrates a front view of a disposable connector or elbow;

Figure 39 illustrates a left side view of the elbow of Figure 38;

Figure 40 illustrates the cross-section of the elbow of Figure 38 through line XL-XL;

Figure 41 illustrates a plan view of the elbow of Figure 38;

Figure 42 illustrates the cross-section of the elbow of Figure 38 passing through line XLII-XLII;

Figure 43 illustrates a lower rear perspective view of the elbow of Figure 38;

Figure 44 illustrates an upper front perspective view of the elbow of Figure 38;

Figure 45 illustrates a detail Z of the cross-section of Figure 40;

Figure 46 illustrates a detail X of the cross-section of Figure 42;

Figure 47 illustrates a front view of a shell/cushion with four-point or spaced channels around the perimeter for connection to the frame;

Figure 48 illustrates a right side view of the shell/liner of Figure 47;

Figure 49 illustrates a cross-section of the shell/liner of Figure 47 through line XLIX-XLIX;

Figure 50 illustrates a plan view of the shell/liner of Figure 47;

Figure 51 illustrates a cross-section of the shell/liner of Figure 47 through line LI-LI;

Figure 52 illustrates a detail Z of the cross-section of Figure 49;

Figure 53 illustrates a cross-section of the shell/gasket of Figure 48 through line LIII-LIII;

Figure 54 illustrates a lower rear perspective view of the shell/cushion of Figure 47;

Figure 55 illustrates an upper front perspective view of the shell/liner of Figure 47;

Figure 56 illustrates a front view of a shell/gasket with a continuous channel around the perimeter to connect to the frame;

Figure 57 illustrates a right side view of the shell/liner of Figure 56;

Figure 58 illustrates a cross-section of the shell/gasket of Figure 56 through line LVIII-LVIII;

Figure 59 illustrates a plan view of the shell/liner of Figure 56;

Figure 60 illustrates a bottom view of the shell/liner of Figure 56;

Figure 61 illustrates a cross-section of the shell/gasket of Figure 57 through line LXI-LXI;

Figure 62 illustrates a side view of the mask assembly of the shell/cushion of Figures 56-61, the frame of Figures 13-20 and the elbow of Figures 30-37;

Figure 63 illustrates a cross-section of the mask assembly of Figure 62 through line LXIII-LXIII;

Figure 64 illustrates a cross-section of the mask assembly of Figure 62 through line LXIV-LXIV;

Figure 65 illustrates a cross-section of the mask assembly of Figure 62 through line LXV-LXV;

Figure 66 illustrates a cross-section of the mask assembly of Figure 62 through line LXVI-LXVI;

Figure 67 shows a headgear according to a disposable embodiment of the present invention;

Figure 68A shows a shell/liner with a bellows section illustrating the elimination of the torque interaction between the elbow and the liner;

Figure 68B shows the shell/liner of Figure 68A, with the bellows section acting as a torque canceller;

Figure 69 illustrates a front view of the frame;

Figure 70 illustrates a right side view of the frame of Figure 69;

Figure 71 illustrates a cross-section of the frame of Figure 69 through line LXXI-LXXI;

Figure 72 illustrates the cross-section of the frame of Figure 69 through line LXXII-LXXII;

Figure 73 illustrates the cross-section of the frame of Figure 69 through line LXXIII-LXXIII;

Figure 74 illustrates a rear view of the frame of Figure 69;

Figure 75 illustrates in detail a portion of the cross-section from Figure 71;

Figure 76 illustrates in detail a portion of the cross-section from Figure 72;

Figure 77 illustrates a right side perspective view of the frame of Figure 69;

Figure 78 illustrates a left side perspective view of the frame of Figure 69;

Figure 79 illustrates a front view of a clip for use with the frame of Figure 69;

Figure 80 illustrates a right side view of the frame of Figure 79;

Figure 81 illustrates a cross-section of the frame of Figure 79 through line LXXXI-LXXXI;

Figure 82 illustrates the cross-section of the frame of Figure 79 through the line LXXXII-LXXXII;

Figure 83 illustrates the cross-section of the frame of Figure 79 through the line LXXXIII-LXXXIII;

Figure 84 illustrates a rear view of the frame of Figure 79;

Figure 85 details a portion of the cross-section from Figure 82;

Figure 86 details a portion of the cross-section from Figure 83;

Figure 87 illustrates a right side perspective view of the frame of Figure 79;

Figure 88 illustrates a left side perspective view of the frame of Figure 79;

Figure 89 illustrates a front view of an elbow according to yet another embodiment of the present invention;

Figure 90 illustrates the cross-section of the elbow of Figure 89 passing through line XC-XC;

Figure 91 illustrates a cross-section of the elbow of Figure 89 passing through line XCI-XCI;

Figure 92 illustrates a plan view of the elbow of Figure 89;

Figure 93 illustrates the cross-section of the elbow of Figure 89 through line XCIII-XCIII;

Figure 94 illustrates in detail a portion of the cross-section of Figure 93;

Figure 95 illustrates in detail a portion of the cross-section of Figure 90;

Figure 96 illustrates in detail a portion of the cross-section of Figure 91;

Figure 97 illustrates a lower rear perspective view of the elbow of Figure 89;

Figure 98 illustrates an upper front perspective view of the elbow of Figure 89;

Figure 99 illustrates a front view of another elbow;

Figure 100 illustrates a cross-section of the elbow of Figure 99 through line C-C;

Figure 101 illustrates a cross-section of the elbow of Figure 99 through line CI-CI;

Figure 102 illustrates the cross-section of the elbow of Figure 99 through line CII-CII;

Figure 103 illustrates the cross-section of the elbow of Figure 99 through line CIII-CIII;

Figure 104 illustrates in detail a portion of the cross-section of Figure 103;

Figure 105 illustrates in detail a portion of the cross-section of Figure 100;

Figure 106 illustrates in detail a portion of the cross-section of Figure 101;

Figure 107 illustrates a lower rear perspective view of the elbow of Figure 99;

Figure 108 illustrates an upper front perspective view of the elbow of Figure 99;

Figure 109 illustrates a front view of another shell/liner;

Figure 110 illustrates a cross-section of the shell/liner of Figure 109 through line CX-CX;

Figure 111 illustrates a cross-section of the shell/gasket of Figure 109 through line CXI-CXI;

Figure 112 illustrates a right side view of the shell/liner of Figure 109;

Figure 113 illustrates a plan view of the shell/liner of Figure 109;

Figure 114 illustrates in detail a portion of the cross-section of Figure 111;

Figure 114A details a portion of the shell/cushion in the nasal bridge region;

Figure 115 illustrates in detail a portion of the cross-section of Figure 110;

Figure 116 illustrates an upper front perspective view of the shell/cushion of Figure 109;

Figure 117 illustrates a lower rear perspective view of the shell/cushion of Figure 109;

Figure 118 illustrates a front view of another buckle for use with the shell/liner of Figure 109;

Figure 119 illustrates a side view of the ring of Figure 118;

Figure 120 illustrates a diameter cross-section through the ring of Figure 118;

Figure 121 illustrates a perspective view of the ring of Figure 118;

Figure 122 illustrates an exploded perspective view of a mask assembly comprising the frame of Figure 69, the clip of Figure 79, the elbow of Figure 99, and the shell/cushion component of Figure 109;

Figure 123 illustrates the mask assembly of Figure 122 with all parts assembled and some parts shown in cross-section;

Figure 124 illustrates a detailed cross-section through the rivets of Figure 122, shell/cushion holes and front frame holes at the bottom of the mask assembly;

Figure 125 illustrates a cross-section through the clasp of the mask assembly of Figures 122 and 123, with the left half showing one configuration for sealing the shell/cushion to the elbow and the right half showing another Configurations that provide a tight fit between the shell/liner and the elbow; and

Figure 126 illustrates a side view of the frame as illustrated in Figures 69-78 with two rivet systems integrally formed therewith.

Detailed ways

§1 Introduction

Embodiments of the present invention in various forms provide a comfortable low cost mask system with few parts and, for example, with a single wall cushion. In the preferred version it does not include a forehead support, nor does it include a headgear clip, but it will be readily understood that these could be included if desired.

Embodiments of the present invention include mask systems that provide a patient interface having a variety of interchangeable subassemblies for delivering a quantity of Part of the device for positive pressure air. The mask system consists of a headgear and mask assembly (see Figure 1).

The various types of mask systems are described with reference to the accompanying drawings:

Type 1: As depicted in Figures 1 and 7 is a reusable mask system having removable parts for cleaning, a shell with a three point single piece frame and a continuous channel with a receiving frame /liner;

Type 2: As depicted in Figures 2-6, 8, and 9 is a reusable mask system having removable parts for cleaning, a shell with a three-point monolithic frame and four separate channels with housing frame /liner;

Type 3: a single-use or disposable device as depicted in Figure 10, which has parts that are detachable for cleaning, with a five-point monolithic frame;

Type 4: as depicted in Figure 11 is a reusable device with removable parts for cleaning, with a five-point monolithic frame;

Type 5: not shown in itself, is a single-use or disposable device, which has a three-point two-piece frame;

Type 6: Not shown per se, is a reusable device with removable parts for cleaning, having a three-point two-piece frame;

Type 7: is a single-use or disposable device, for example, in Type 3 or 5 with an elbow or connector as depicted in Figures 99-108;

Type 8: is a reusable device, for example, in Type 1, 3 or 5 with an elbow or connection as depicted in Figures 89-98; and

Type 9: Not shown per se, is a reusable or single-use device of any of the preceding eight types with a shell/liner as depicted in FIG. 68 .

Embodiments of the invention also include four types of elbows or connections that connect the mask to the tubing so that the connection completes the mask:

Type A: is a reusable detachable elbow as depicted in Figures 30-37;

Type B: is a one-time use elbow, which cannot be disassembled once installed on the mask, as shown in Figures 38-46;

Type C: is a reusable detachable elbow as depicted in Figures 89-98; and

Type D: is a single-use elbow that cannot be removed once installed on the mask, as shown in Figures 99-108.

Embodiments of the present invention also include five types of frames that attach to the shell/cushion and headgear to position the mask assembly on the patient:

Type (i): a one-piece three-point frame accommodated in the channel of the shell/liner as shown in Figures 13-20;

Type (ii): a one-piece five-point frame accommodated in the channel of the shell/gasket as shown in Figures 21-25;

Type (iii): two-piece three-point frame as shown in Figures 69-88, which clamp flanges on the shell/liner to provide an exoskeleton support structure for the shell/liner;

Type (iv): Not shown, is a two-piece five-point frame that sandwiches flanges on the shell/liner to provide an exoskeleton support structure for the shell/liner. This type is similar to type (iii) shown in Figures 69-88; and

Type (v): Not shown, where the frame is one piece and riveted to the flange of the shell/liner.

Embodiments of the invention also include eight types of shells/liners:

Type I: is a reusable shell/liner as shown in Figures 1, 7 and 56-66, which shell/liner has a single continuous channel to accommodate the frame;

Type II: is a single-use shell/liner as shown in Figures 1, 7 and 56-66, the shell/liner having a single continuous channel to accommodate the frame;

Type III: is a reusable shell/liner as shown in Figures 2-6 and 47-55, the shell/liner has a plurality of discrete channels to accommodate the frame;

Type IV: is a single-use shell/liner as shown in Figures 2-6 and 47-55, the shell/liner has a plurality of discrete channels to accommodate the frame;

Type V: for shells/gaskets as shown in Figures 109-117, provided with flanges around the perimeter and intended for re-use;

Type VI: for a shell/gasket as shown in Figures 109-117, provided with a flange around the perimeter and intended for single use;

Type VII: not shown, but similar to the shell/liner of Figures 109-117, except that this type shell/liner has multiple discrete flanges or shells surrounding holes for re-use; and

Type VIII: Not shown, but similar to the shell/gasket of Figures 109-117 except this type has a plurality of discrete flanges or shells surrounding holes for single use purposes.

As illustrated in FIG. 1 , a mask system 1 generally includes a mask assembly 10 having a shell/cushion 30, a frame 40, a connector or elbow 50, and a clasp 60 (which is not visible in FIG. 7 is visible). It will be readily appreciated that combinations of the various basic components described above will result in a multitude of mask system configurations.

§2 headband

The headgear 20 shown in Figures 1, 12 and 67 consists of three separate straps 20.1, 20.2 and 20.3 forming a triple headgear system, the straps consisting of white non-rubber elastic bands bonded together. The headband 20 is attached to the frame 40 through the buttonholes 20.4 of the straps 20.1 and 20.2.

Table 1 shows typical dimensions for each of the strips 20.1, 20.2 and 20.3.

Table 1 Reference number Strip length(mm) quantity 20.1 500～700 1 20.2 350～500 1 20.3 150～250 1

Button holes (3-5 mm) are arranged in the middle along the entire strip, and the interval between two button holes is about 3.5-6.5 mm. The straps 20.1 , 20.2 and 20.3 are each 20 mm wide and consist of a white biocompatible 70% polyester and 30% non-rubber elastomer weave. A preferred material has an elasticity of 49±20 Newtons per meter (Nm ⁻¹ ). The above dimensions and materials are exemplary only.

Common headgear can be a major cost in the production of a mask system. Thus, by producing the headgear 20 from this particular low cost material, a significant reduction in the overall cost of the headgear and mask system can result.

The headgear 20 as described above is preferably intended for one use and then disposed of. However, in order to make a reusable headband, the headband can be molded in many parts and then joined together with buttons or the like. Alternatively, the reusable headband can be integrally molded.

Figure 67 shows a plan view of the headband 20, while Figure 12 shows the headband 20 used on a head model.

§3 shell/liner

Illustrated in Figures 1, 7, 11 and 56-66 is the shell/liner 30. The shell/cushion 30 forms a nose receiving cavity 30.1 and forms a seal with the patient's face. The shell/cushion 30 has a rear hole 30.2 through which the patient's nose passes in use and a front hole 30.3 for connection to the connector or elbow 50. In the preferred form, the shell/cushion 30 is single walled, however, in other forms it may have double or multiple walls, similar to the face masks taught in U.S. Patent 6,112,746 (incorporated herein by reference), Known under the trademark MIRAGE(R). The shell/gasket 30 has a sealing structure 30.5 and a support structure 30.4 of substantially fixed cross-section. It may be molded from any suitable material, such as silicone or thermoplastic elastomer.

The sealing structure 30.5 has a face-contacting side 30.51 adapted to form a seal on the patient's face. The face-contacting side 30.51 includes a nose bridge region 30.6, a side region 30.7 and a lip region 30.8. It can be seen from the figure that the lip region 30.8 has a series of four ventilation holes 30.9 therethrough. The face-contacting side 30.51 is similar in shape to the face-contacting side of known masks under the trademark PAPILLION (manufactured by MAP GmbH) or known masks under the trademark MIRAGE (manufactured by Reesmed GmbH).

Various shell/cushion 30 sizes may be provided to accommodate different sized noses. For example, in one form, the shell/cushion 30 may have a shallow nose bridge region 30.6.

The shell/cushion 30 includes a frame receiving channel 140 defined by a front flange 34 and a rear flange 36 . The shell/gasket 30 of Figures 7, 8 and 56-61 has a front flange 34 that accommodates a channel 140 of the frame as a continuous or uninterrupted channel, the front flange 34 encircling the shell/gasket 30. The perimeter extends 100% of the path.

As can be seen in Figure 56, the rear flange 36 is slightly wider in the lip region 30.8 and in the side region 30.7. In these wider portions on the two side regions 30.7 are elongated grooves 30.75 which provide additional structure for engaging and securing the frame 40 or 140, as will be described in more detail below.

Another shell/liner 130 is illustrated in FIGS. 2-6, 8, 9, 10 and 47-55. This shell/gasket 130 is similar to the shell/gasket 30, and like parts have like numerals. Shell/liner 130 differs from shell/liner 30 in that instead of providing a consistently continuous or complete channel 140 around the shell/liner, discrete channels 140.1, 140.2 and 140.3 are provided, in conjunction with a fourth channel 140.4 (see FIG. 48 ) form four scattered points to accommodate the four points on the frame 40. Each dispersion channel 140.1, 140.2, 140.3 and 140.4 is formed between the continuous rear flange 36 and the intermittent front flange 34. The rear flange 36 wraps around the shell/pad 130 all the way around the perimeter of the shell/pad 130, providing a flange against which the frame 40 or 140 can be pushed. Part of the rear flange 36 in the lower side region 30.7 and lip region 30.8 is thicker than in the nose bridge region 30.6 in order to prevent the formation of "knife edges" in the nose bridge region 30.6, but to provide for the formation of the two lower ends of the shell/cushion 30 Vertex structure.

The shell/cushion 130 includes a series of vent holes or vents 30.9, in a preferred form four vents. The vent 30.9 is formed through the thicker wall portion 30.10 integrally formed with the shell/gasket 30 . The wall section 30.10 is shown in FIG. 3 . The wall portion 30.10 has two functions. The first is to form the front flange which forms the lower channel 140.4 with the rear flange 36 in the lip region 30.8. A second effect is that the wall portion 30.10 places the vent 30.9 at an angle to the elbow. However, the ventilation holes 30.9 can be formed at a flatter angle, for example 10° to 15° to the vertical (relative to the orientation shown in FIG. 3 ), so that when the patient puts on the mask system 1 and lies down, , typically the air vents 30.9 will be arranged approximately 10°-15° from the horizontal.

As shown in Figures 4, 8, 9, 48, 49, 56 and 57, the rear flange 36 of the frame receiving channel 140 has different thicknesses in different regions. This feature is common to both shell/liner 30 and 130, but for convenience only shell/liner 30 has been described in the preceding paragraphs. The rear flange 36 of the bridge of the nose area 30.6 is thinner than the side area 30.7 and lip area 30.8 of the underside. The thickness of the rear flange 36 in the nose bridge area 30.6 is between 1 and 3 mm, preferably 2 mm, while that in the underside side area 30.7 and lip area 30.8 may be 5 mm thick. This provides sufficient support for the sealing structure 30.5 of the shell/cushion 30 in the nasal bridge region 30.6, but without creating an uncomfortable "knife edge" for the patient. If the sealing structure 30.5 of the shell/cushion 30 collapses and a harder or thicker portion of the shell/cushion 30 is used in the bridge region 30.6, a "knife edge" may form. A "knife edge" is undesirable because it can produce bedsores on the patient's face with prolonged use. Figures 63 and 64 show a section from Figure 62 with a thicker rear flange region 36, while a similar rear flange section 36 in Figures 65 and 66 is shown with a thinner rear flange region.

Thus, as can be seen from shells/liners 30 and 130, the shells/liners can have discrete channels or continuous channels. The channel or channels may be 75% to 100% of the perimeter of the shell/pad in the case of the shell/pad 30 when their lengths are added; in the case of the shell/pad 130 of the frame 40, The channel or channels may range from 20% to 40% of the perimeter of the shell/liner. An advantage of a front flange extending 75% - 100% of the way around the perimeter is that it is almost impossible to inadvertently remove it. As can be seen from Figures 56 and 47, the shell/gasket 30 and 130 has a wider portion of the rear flange 36 extending around the two lower apexes, thereby occupying approximately 60% of the shell/gasket 30 and 130 around. To achieve the desired structural function and fit in the nasal bridge region, this wider flange may occupy about 40% to 80% of the perimeter of the shell/cushion 30 and 130 centered on its lower region.

Figure 52 shows the area 30.31 of the shell/liner 130 in cross-section. Area 30.31 is the part that connects to the front hole 30.3, which will receive the clasp 60. Area 30 . 31 has a channel 524 that accommodates the rear flange of buckle 60 . The patient end of the hole has a relatively thin and flexible annular flap 526 which reduces the inner diameter of the hole 30.3. The purpose of the flap 526 is to provide a seal with a portion of the connection or elbow 50, as described below in Section §7 Assembly of Parts.

Region 522 as shown in FIG. 52 is a relatively thin wall portion. Such thin-walled portions are particularly advantageous in the manufacture of disposable masks. The thin walled portion 522 can therefore be designed to tear if the patient attempts to remove the connector or the elbow 50 , for example to clean the elbow 50 . This approach presents a safety feature that prevents re-use of the disposable mask with shell/cushion 130, reducing the possibility of cross infection.

Alternatively, if the shell/liner 130 is to be reused, the region 522 has a thicker dimension that prevents the region 522 from tearing when disassembled. Shell/liner 30 to be reusable would have a cross-section similar to FIG. 52 with region 522 having thicker dimensions than shell/liner 130 .

A schematic diagram of a modified shell/liner 230 is shown in FIG. 68 . In such a shell/liner 230, a small bellows portion 230.1 is provided adjacent to the hole 30.3 where the connector or elbow 50 fits into the shell/liner 230 (or alternatively a flexible neck could be provided). This bellows portion 230 . 1 provides a flexible part allowing movement between the connection piece or elbow 50 and the shell/gasket 230 . By providing this flexibility, any torque transmitted between the elbow and shell/liner can be decoupled from the interaction.

Figures 109-117, 122 and 123 show another shell/gasket 330 which is similar to the shells/gaskets 30 and 130 described above and like parts are numbered like. Shell/liner 330 differs from shells/liner 30 and 130 in that instead of providing channel 140 or series of discrete channels 140.1, 140.2, 140.3 and 140.4 around perimeter containment frame 40, continuous perimeter fins or Flange 330.1. The flange 330.1 has the same shape as the two-piece frame that clamps the flange 330.1 (see description below with respect to Figures 69-88).

Flange 330.1 includes seven perforations 330.2 and 330.3. The four holes 330.2 have a diameter of about 5.75 mm and the three holes 330.3 have a diameter of about 3 mm. Holes 330.2 and 330.3 accommodate the passage of rivets formed in one of the two-piece frames, as will be described below. Since the rivet passing through the hole 330.2 has a barbed head that is larger in diameter than the shank, the diameter of the hole 330.2 is larger to accommodate the larger diameter barb.

While Figures 109-117 show a continuous flange 330.1 around the perimeter of the shell/liner 330, satisfactory results are also expected if a series of seven discrete flanges or shells were to be provided around holes 330.2 and 330.3. This will give the frame clamping these flanges approximately seven points of pinch or contact with the shell/pad which are expected to be sufficient to maintain the shape of the shell/pad in use.

As can be seen in Figure 114, the surface of the shell/cushion 330, which provides a seal to the patient's face, has a sandblasted surface finish. Such a sandblasting finish will bring more comfort to the patient. The cross-section of FIG. 114 is taken through the middle region of the shell/gasket 330 . It can be seen in Figure 114 that in the area designated by the wall 330.11, behind the flange 330.1, the thickness of the wall 330.11 remains relatively thick and then tapers in the rearward direction. In contrast, as shown in Figure 114A, in the nasal bridge region 30.6, this cross-section differs so that the wall 330.11 (shown in dashed lines for comparison) becomes thinner, becoming a relatively thin wall 330.12 and substantially constant transverse section wall section. This reduction in wall thickness in the nasal bridge region 30.6 helps to reduce the chance of "knife edges" forming in the nasal bridge region 30.6 during patient use.

As shown in Figures 109, 110, 112 and 113, the shell/liner 330 is shown with production or release tabs 330.13. The stripping tabs 330.13 allow the robotic stripping machine to safely and securely grasp the shell/liner 330 without having to grasp any other part of the shell/liner 330. This may reduce the likelihood of damage to any other components of the shell/cushion 330 during the cutting by the robot of any excess material that may result from the molding process.

The shell/liner 330 is particularly intended for hospital single use. As can be seen from Fig. 115, the shell/liner 330 has a thin walled portion, about 0.33-0.75mm thick. As noted above, there is provided a line of weakness such that an attempt to remove the buckle 60 from the groove 524 would cause the shell/liner 330 to tear. This tendency to tear limits the possibility of cleaning the shell/liner 330 before reuse, thus preventing re-use.

To provide some additional rigidity while maintaining an optimum level of material used, the shell/liner 330 is provided with a series of four radially extending stiffening ribs 330.4 extending from the surrounding areas 30.31 and holes 30.3. A generally circular reinforcing ring 330.6 extends out. Ribs 330.4 and 330.6 are integrally formed in shell/liner 330, but are thicker in material than region 330.5. While the thickness of the region 330.5 is about 1-1.5 mm, the thickness of the ribs 330.4 and 330.6 is about 2-3 mm. This arrangement contributes to a better aesthetic quality, while also providing the stronger structural support needed, but a softer feel at the seal site.

§4 Framework

As shown in Figures 1-9 and 12-18, the frame 40 is shaped and adapted to fit over the shells/pads 30 and 130 and provides an anchor point 132 with holes 40.1, 40.2 and 40.3 for the headband 20 . The frame 40 provides three anchor points 132 and is shown in detail in Figures 13-20.

Frame 40 is generally triangular in shape with a rounded top, approximately 90mm wide at the base, and approximately 84mm high. Other typical dimensions are shown in Figures 13-20.

Frame 40 may be fabricated in any suitable configuration of anchor points 132 to provide a variety of fits to suit the particular needs of an individual use. In this regard, the alignment of the anchor points 132 may be varied in accordance with the methods described in published PCT patent application WO 02/45784, the contents of which are incorporated herein by reference. In this way, the adaptability of the mask system 1 is enhanced since the mask frame 40 is relatively inexpensive to manufacture.

Each anchor point 132 is formed by a frame member 132.2 surrounding the aperture 40.1, 40.2 or 40.3. The holes 40.1, 40.2 or 40.3 allow the ends of the straps 20.1 and 20.2 to pass therethrough.

In the middle of the frame member 132.2 is a tumbler 132.1 which passes through a buttonhole 20.4 at the respective ends of the straps 20.1 and 20.2. In another embodiment, the pegs may be replaced by other means of securing, such as hooks.

If desired, the user does not need to pass through the holes 40.1, 40.2 or 40.3, but instead directly connects to the tumbler 132.1, but in use, if the ends of the straps 20.1 and 20.2 pass through the respective holes 40.1, 40.1, 40.2 or 40.3, there is little chance of inadvertent disengagement because all movement of the ends of the straps 20.1 and 20.2 will not tend to pull the buttonhole 20.4 out of the tumbler 132.1.

FIG. 18 shows a detailed view of the tumbler 132 . 1 of the positioning point 132 in cross section from FIG. 14 . In use, the patient selects the appropriate buttonhole 20.4 on the headgear 20, then passes it through the hole 40.1, 40.2 or 40.3, and buckles it on the stud 132.1 of the frame 40 to set the straps of the headgear. for the appropriate length.

In the vicinity of the two lower anchor points 132, near the bottom of the frame 40, the frame 40 has rearwardly projecting ribs 40.7. The ribs 40.7 are sized and shaped to be received in the grooves 30.75 extending on the shells/pads 30 and 130.

As shown in Figures 14 and 15, the frame 40 has indents 40.4 also extending from the patient's face. The serrations 40.4 help to provide space for the nasal bridge portion of the shell/cushion 30 and 130 without creating pressure points on the patient's nasal bridge.

Shown in FIGS. 10, 11 and 21-25 is an alternative frame 140 similar to the frame 40 of FIGS. 14 and 15, and like parts have been numbered like. The difference between frame 40 and frame 140 is that frame 140 provides a maximum of five anchor points 132 .

The upper anchor point 132 includes three side frame members 132.2, on each side of the frame member 132.2, a tumbler 132.1 is generally centrally located.

The frame 140 may thus be used with the above-described headgear 20 having three strap ends 20.1 and 20.2, or it may be used with a modified shape (not illustrated) headgear having five straps.

Optionally (not illustrated), the frame 140 may also have four anchor points 132 and be used with a modified shape headgear (not illustrated) having four straps.

Preferably, the three straps that can be used with the upper anchor point 132 are each passed through the hole 40.2, so that the straight side features on three sides will interact with the respective ball pegs 132.1 to securely attach the strap ends fixed there.

Shown in FIGS. 69-78 is the first piece 240 of the frame for use with the shell/pad 330 of FIGS. 109-117 , 122 and 123 . Once mounted, the sheet 240 is part of the outer surface of the frame.

Shown in FIGS. 79-88 is the second piece 340 of the frame for use with the shell/pad 330 of FIGS. 109-117 , 122 and 123 . Once mounted, the sheet 340 is part of the inner surface of the frame.

Sheets 240 and 340 are similar in overall shape to frames 40 and 140, and like parts are numbered like.

The sheet 240 is received and held therein by four large diameter holes 240.1, which can be best seen in Figs. Channel 240.2. In another embodiment, there may be 1 to 5 large diameter holes 240.1. The tapered entry channel 240.1 forms a narrow hole 240.4 and a large diameter groove 240.3 on the other side of the hole forming the entry channel 240.2. The large diameter groove 240.3 has a shoulder 240.5 at its bottom.

Holes 240.1 in sheet 340 accommodate rivets 340.1. As can be seen in Figures 82, 83, 86 and 86, the rivet 340.1 has a tapered shank 340.2 and a tapered head 340.3 with a shoulder 340.6 underneath. Surrounding the bottom of the rod 340.2 is a housing 340.4 with an annular groove 340.5 between the bottom of the rod 340.2 and the housing 340.4. The tapered end of the round head 340.3 allows the head 340.3 to be pushed into the channel 240.2 and hole 240.4, once passed, the shoulders 240.6 and 240.3 will abut each other to prevent the rivet 340.1 from being withdrawn from the hole 240.1.

The sheet 240 includes three blind holes 240.6 that receive straight side pegs 340.7. In another embodiment, there may be a different number of blind holes and respective straight side plugs, for example 1 to 7 blind holes and respective plugs.

Figure 126 shows a frame 440 similar to the frame piece 240 of Figures 69-78. Accordingly, like parts are labeled with like numbers. Frame 440 differs from frame 240 in that frame 440 does not require a second frame member for use therewith. Instead the frame 440 has a rivet 440.1 positioned adjacent to each hole 240.1. For convenience only one rivet is shown with guy wire 440.3 tying rivet 440.1 to frame 440. A bearing surface 440.4 is provided from which extends a rivet shank 440.5 which terminates in a round head 440.6. Rivets 440.1 including guy wires 440.3 can be integrally molded with frame 440 and easily installed.

To install rivet 440.1, frame 440 is positioned adjacent to flange 330.1 of shell/liner 330, then rivet 440.1 is moved into position against the back of flange 330.1, pushing in so that bearing surface 440.4 can clamp or press against flange 330.1 on the back of the frame 440 .

For illustration, the holes 240.1 near the bottom of the frame 440 have a different rivet configuration associated therewith. Rivet 440.2 has a relatively thin face plate 440.7 extending from frame 440. The second panel 440.8 is linked to the panel 440.7 by a hinge 440.9. Extending from the panel 440.8 in much the same manner as the rivet 440.1 is a rivet shank 440.5 which terminates in a round head 440.6.

The distance between the hinge 440.9 and the frame 440 (the height of the panel 440.7) can be set to provide a loose or snug fit around the flange 330.1, or to compress the flange 330.1 as tightly as possible if desired. Rivet 440.2 secures flange 330.1 in position relative to frame 440 by flange 330.1 being arranged adjacent to hole 240.1 and folded panel 440.8 so that rivet head 440.6 can be forced into hole 240.1.

Frame 40, sheets 240 and 340, and frame 440 may be molded from any suitable material, such as polycarbonate.

§5 Connecting piece or elbow

1, 7, 9, 11, 12, 62-66, especially as shown in FIGS. 30-37, with or without swivel bearings or joints 250.2 (see FIG. 1 ) with air delivery ducts (not shown), The elbows 50 each have an end 52 adapted for engagement. Connector 250.2 is shown in Figure 1, but is optional. Fitting 250.2 connects to elbow 50 in such a way that the cylindrical inner surface of end 52 includes an annular groove 250.1 that receives circumferential edge 250.3 on swivel bearing 250.2 (see Figures 11, 32, 35A and 35B).

The proximal end 50.1 of the elbow 50 is adapted to engage both the shell/liner 30, 130, 230, 330 and the clasp 60 disposed within the bore 30.3 of the shell/liner. Two tongues 50.3, equidistant circumferentially or diametrically opposite, extend outwardly from the body of the elbow 50 near the proximal end 50.1. Each tongue 50.3 has an arcuate undercut 50.2 on an inward facing surface 50.4 of the tongue 50.3. The undercut 50 . 2 engages with the clasp 60 . The fingers 50.3 are each located at diametrically opposite locations on the elbow 50 and are located on either side of the elbow 50 at proximal ends 50.1.

There is a built-in finger clip 54 at the end of the tongue 50.3. The finger clip 54 enables the user to pull the tab 50.3 radially outward relative to the proximal end 50.1, thereby allowing the undercut 50.2 to pass over the flange of the clasp 60. This then allows the elbow 50 to be removed from the mask system 10, and the elbow 50 can be removed for cleaning. Adjacent the finger clips are two undercuts that movably engage the clasp.

The inner surface of the finger clip 54 includes a tapered entry channel 50.7 so that when the proximal end 50.1 is pushed into contact with the buckle edge, the finger clip 54, and thus the undercut 50.2, is pushed away from the edge of the buckle 60 , so that the undercut pushes over the edge and then biases it radially inwardly back into engagement, preventing separation of the proximal end 50.1 from the clasp 60.

Representative shapes and dimensions of the elbow 50 are shown in FIGS. 30-37.

Another elbow 150 is shown in FIGS. 10 and 38-46. Elbow 150 is similar to elbow 50 described above, and like parts are numbered like. However, elbow 150 differs from elbow 50 in that elbow 150 does not include movable tongue 50 . 3 and finger clip 54 that elbow 50 includes. Instead, the elbow 50 has six discrete undercuts 50.2 equally spaced on the inner edge of the skirt 50.6 surrounding the proximal end 50.1. The elbow 150 is thus not removable from the shell/cushion 30, 130, 230, 330, thus, it is used in a disposable mask.

The undercut 50.2 is formed adjacent to the hole 50.11 through the skirt 50.6. The hole 50.11 is formed through the part of the mold forming the undercut 50.2 to prevent molten plastic from occupying that part of the space. More or less discontinuous undercuts may be provided if desired.

The inner surface of the skirt 50.6 includes a tapered entry channel 50.7 so that when the proximal end 50.1 is pushed into contact with the edge of the buckle 60, the skirt 50.6, and thus the undercut 50.2, is pushed away from the edge of the buckle 60 , so that the undercut 50.2 is pushed over the edge. The configuration of the skirt 50.6 provides a radially inward bias to force the undercut 50.2 back into engagement once pushed past the edge, thereby preventing disengagement of the proximal end 50.1 from the clasp 60.

The elbow may be molded from any suitable material such as polycarbonate or polypropylene.

Elbow 50 and elbow 150 each include a port 56, such as a Luer port, to provide access to the interior of the mask shell/cushion. For example, a pressure sensor can be connected. A polypropylene or silicone cap can be used to cover and seal the interface when not in use.

Elbow 50 and elbow 150 may be sized to rotate freely when mounted on mask system 10 . However, preferably they cannot rotate freely. Thus, while allowing rotation, the intermesh engagement of the components acts as a braking system when mounted on the mask system 10 . This means that, when adjustable, it tends to stay where it was originally set. This can be accomplished by a combination of the dimensions shown and the use of one material for the elbow 50 and a different material for the shell/liner to which it is joined. This is accomplished by a slight interference fit between the end of the undercut 50.2 on the elbow 50 and the shell/gasket 30, 130, 230, 330.

A suitable combination of materials and component construction is preferably selected to allow the user to easily rotate the elbow by hand to any desired position and, once positioned, when the mask is connected to the gas line and the sleeping patient is in use, The elbow 50 or 150 will not move under the applied force. This allows the user to position the elbow 50 or elbow 150 and gas tubing relative to the mask and face according to personal preference.

Since the elbows 50 and 150 are connected to the frame 40 through the shells/gaskets 30, 130, 230, 330, they are not directly connected. Since the shell/gasket is constructed of a flexible material, movement of the air delivery tubing attached to the swivel elbow does not directly break the shell/gasket seal. In this way, elimination of the effect of drag forces from the air delivery duct is achieved.

A connector or elbow 250 similar to elbow 50 is shown in Figures 89-98, and like parts are numbered like. Elbow 250 differs from elbow 50 in two salient features. The first is that the elbow 50 is connected directly to the duct to supply air through the end 52 . However, the elbow 250 provides a recess 250.1 at its end 52 to receive at the end a 180° joint 250.2 (see Figure 122 joint 250.2), which is rotatably connected by an annular edge 250.3 thereon, which Accommodated in the annular groove 250.1. This provides a swivel connection between the duct supplying the air and the elbow 250 .

The second different feature is that, as can be seen from the cross-section of Fig. 91, the elbow 250 has a vent wall 250.4 extending from a channel wall 250.5 directly to the air outlet of the elbow. .

As can be seen in detail in the cross-section of Figure 95, in the vent wall 250.4 is a series of four vent openings 250.6. The port 250.6 is positioned at an angle to the direction of the elbow 250 airflow outlet. This angle is approximately 35°, or as shown in Figure 90 the supplementary angle is 55°.

Extending from the vent wall 250.4 is a flared housing 250.7. By gradually expanding, any gas expelled through the vent openings 250.6 will be easily dispersed.

Figures 99-108, 122 and 123 show a connection or elbow 350 similar to elbow 150, and like parts are numbered like. Elbow 350 also has the same first and second features described above or is different with respect to elbows 50 and 250 , and accordingly like parts are also labeled with like numbers.

Elbow 350 is used to produce mask systems primarily for single-use and hospital use, which include side-located and oriented Lue ports 56 . The side-mounted Lue ports 56 are particularly useful for connecting conduits for monitoring. By mounting such a conduit on the Rue port 56 of the elbow 350, if it were free to rotate, it would mean that the monitoring conduit would not need to be twisted relatively to the gas supply line. This would not happen if the lue port 56 was on the shell/liner.

When the connectors or elbows 250 and 350 are only at an angle of 90° between the inlet of the distal end 52 and the outlet of the proximal end 50.1, it will be readily understood that the connector can be formed by the vent wall 250.4, the vent orifice 250.6 and the diffuser. The housing 250.7 is constructed at any suitable angle between the inlet at the distal end 52 and the outlet at the proximal end 50.1. This angle can be 180° so that straight or joint connections can be produced.

§6 buckle

Buckle 60 for use with mask assembly 10 is shown in Figures 7, 8, 9 and 11 and in more detail in Figures 26-29. Ring 60 may be fabricated from any suitable material, such as polycarbonate.

The ring 60 has an outer diameter of about 33mm and a thickness of 9mm. Other representative dimensions are shown in FIG. 27 . Figures 8 and 9 show how the buckle 60 fits into the mask system in use.

As shown in the cross-sectional views of Figures 8 and 9 and Figures 26-29, it can be seen that the buckle 60 includes a cylinder 62, an annular front flange 64 and a rear flange 66, between the front flange 64 and the rear flange 66. An annular groove 67 is formed. The rear flange 66 is adapted to be inserted and secured within a complementary shaped channel 524 adjoining the front aperture 30.3 of the shell/gasket 30, 130, 230, 330.

The front flange 64 presents a right-angled rear surface 65 forming the front wall of the recess 67 . Additionally the edge 68 of the front flange 64 is beveled or tapered so that when it enters the tapered entry passage on the elbow 50 it will force the undercut 50.2 over there.

Note that the rear flange 66 is symmetrical in shape while the front flange 64 is not. Further, the rear flange 66 is disposed behind the rear end of the cylinder 62 such that the cylindrical portion 69 protrudes axially rearward from the rear surface of the rear flange 66 .

Another form of clasp 160 similar to ring 60 is shown in Figures 118-123, and like parts are numbered like. Ring 160 differs from ring 60 in that ring 160 has a symmetrical structure such that it can be inserted in any orientation. Both the front and rear flanges are numbered 64 , are mirror images of each other and are similar in shape to the front flange 64 of the ring 60 . That is, both include beveled or tapered edges 68 . Note that ring 160 does not include a rearward axially extending cylindrical portion such as feature 69 present on ring 60 .

As can be seen from the cross section in Figure 120, the hole through the ring 160 has scaled walls 160.1 and 160.2. The walls are angled or tapered at 20° to facilitate molding of the ring 160 and to prevent the proximal ends 50.1 of the elbows 50 and 250 from disengaging when the elbows are detached from the ring 160. stuck.

The shape of the groove 524 on the shell/liner that receives the flange 64 of the ring 160 is preferably a complementary shape that allows the ring 160 to provide support.

§7 Assembly of parts

With reference to Figures 7, 8 and 9, the assembly of the Type 1 mask system described in Section § 1 above will now be described.

The frame 40 is pushed into position on the shell/liner 30 from the front of the shell/liner 30 , inserted and engaged with the channel 140 on the shell/liner 30 . Buckle 60 is adapted to engage channel 250 on shell/gasket 30 . The method is similar to the first embodiment.

8 and 9 of the cross-sectional views of mask assembly 10, the connection between elbow 50, buckle 60 and shell/cushion 30 can be seen. The rear flange 66 of the buckle 60 is adapted to be inserted and retained in the channel 524 adjacent the front hole 30 . 3 of the shell/cushion 30 .

The undercut on the elbow 50 is adapted to engage the rear surface of the front flange 64 to retain the elbow 50 .

A seal is formed between the flange or tab 526 on the shell/gasket 30 and the proximal end 32 of the elbow 50 when the proximal end 50.1 passes through the buckle 60. In this way, since the flange or tab 526 extends in an annular fashion across the proximal end of the elbow, a leak-proof seal is formed that allows the elbow 50 to rotate relative to the shell/liner 30 . This creates a suitable seal between the shell/gasket and the elbow.

With reference to Figures 122-125, the assembly of the Type 7 mask system described in the introduction to § 1 above will now be described.

Type 7 assembly is very similar to that of Type 1 above, except that instead of a single piece frame 40 a two piece frame consisting of pieces 240 and 340 is used, and instead of a shell/liner 30 with channel 140 a belt perimeter is used Shell/gasket 330 of flange 330.1. Assembly of (a) frame to shell/gasket, and (b) buckle and elbow to shell/gasket can be done in any order.

To assemble the frame, the producer aligns the rivets 340.1 and pegs 340.7 with the respective holes 330.3 and 330.2 and then inserts the rivets and pegs into these holes in a rearward to forward direction starting from the rear of the shell/liner 330 . Once the rivet is received in the hole 330.2, the remainder of the flange 330.1 is arranged to abut the front surface of the sheet 340, the sheet 240 is then aligned so that the hole 240.1 is aligned with the rivet 340.1, and pressure is then applied on the two sheets 240 and 340, To force the conical round head of the rivet 340.1 through the narrow hole of the hole 240.1. The flange 330.1 needs to be compressed by suitably sizing the rivet 340.1 and the hole 240.1 so that once the round head of the rivet snaps into the hole 240.1, the sheets 240 and 340 will have the flange 330.1 pinched between them. Alternatively, as shown in Figure 124, the space between sheets 240 and 340 may be sized to accommodate flange 330.1 without creating any pressure.

When the rivet 340.1 is seated in the hole 240.1, the peg 340.7 passes through the hole 330.3. Three pegs 340.7 prevent the flange 330.1 from falling out of the sandwich formed by the clamping of the sheets 240 and 340.

The steps for mounting the retaining ring 160 and elbow 350 to the hole 30.3 of the shell/gasket 330 are the same as described above for Type 1 . Once the elbow 350 is mounted on the retaining ring 160 and shell/liner 330 as shown in FIG. ), or as shown in the left half of FIG. 125, the flange 526 may be circumferentially engaged with the outer cylindrical surface 32.2 of the adjacent edge 32.1.

The foregoing is a feature of a single use mask assembly wherein the thickness of the shell/cushion 30, 130, 230 and 330 is reduced to provide a tear point. Single use types can be produced without such weak lines or tear points. Where a single use elbow is used, such as the aforementioned elbow 150 or 350, such a single use type will allow the shells/liners 30, 130, 230 and 330 (without any loss of thickness or without any tear points) The assembled buckle 60 or 160 and elbow 150 or 350 are disassembled while the buckle 60 or 160 remains engaged on the elbow 150 or 350 . Thus, since the clasp 60 or 160 cannot be extracted or disassembled from the elbow 150 or 350, such a mask assembly will not be able to be reassembled.

While the invention has been described in terms of preferred embodiments, it should be understood that these embodiments are merely illustrative of the application of the principles of the invention. Many changes may be made therein and other arrangements may be devised without departing from the spirit and scope of the invention.

It is to be understood that the invention herein disclosed and defined extends to all alternative combinations of two or more of the individual features referred to or evident from the description. All these different combinations constitute various options of the present invention.

Claims (53)

1. A mask system for the treatment of sleep-disordered breathing comprising a headgear, a shell/cushion comprising a channel adjacent to the front aperture, a frame, an elbow comprising at least one undercut on the proximal end and comprising a rear flange and A buckle for a front flange for retainable insertion in the channel of the shell/liner, the front flange being adapted to retainably engage at least one undercut of the elbow. 2. The mask system of claim 1, further comprising a thin-walled member proximate the channel of the shell/cushion, the shell/cushion being adapted to tear off when the elbow is removed. 3. A mask system for the treatment of sleep-disordered breathing comprising a headgear, a frame and a shell/cushion including a channel for receiving the frame formed by a front flange and a rear flange surrounding the shell 75% to 100% of the perimeter of the liner/cushion extends, wherein the frame is adapted to be detachably inserted into the frame-receiving channel of the shell/pad. 4. A mask system as claimed in claim 3, wherein the rear flange is 1 mm to 3 mm thick in at least the nasal bridge region of the shell/cushion for contacting the nasal bridge region of the patient. 5. The mask system of claim 4, wherein the rear flange is about 2mm thick. 6. A connection for connecting a mask to a duct delivering airflow to said mask, said connection comprising an inlet and an outlet and a channel wall for delivering the airflow between them, said connection being between the outlet and the inlet The vicinity of the outlet includes a vent hole wall extending from the channel wall, and the vent hole wall includes at least one hole passing through the vent hole wall. 7. An attachment as claimed in claim 6, wherein said attachment is integrally formed with said mask. 8. An attachment as claimed in claim 6, wherein said attachment is made separately from said mask and is then connectable or attachable to the mask. 9. A connector as claimed in any one of claims 6 to 8, wherein said connector is integrally formed with said duct. 10. A fitting as claimed in any one of claims 6 to 8, wherein said fitting is made separately from said pipe and is then connectable or attachable to said pipe. 11. A fitting as claimed in any one of claims 6 to 10, wherein the fitting is made so that the outlet is at any suitable angle to the inlet. 12. The connector as claimed in claim 11, wherein said connector is formed so that said outlet and inlet are at an angle of 90[deg.] to 180[deg.]. 13. A connector as claimed in claim 12, wherein said connector is a 90° elbow. 14. An attachment as claimed in any one of claims 6 to 13, wherein said attachment includes attachment structure for attaching said attachment to said mask. 15. The attachment of claim 14, wherein said attachment structure includes at least one snap-fit undercut for engaging a mating flange on said mask. 16. An attachment as claimed in claim 14 or 15, wherein said attachment structure removably attaches said attachment to said mask. 17. A connector as claimed in claim 16, wherein said connecting structure includes a movable portion on which said snap-fit undercut is formed, said movable portion allowing said The undercut is disengaged from said flange. 18. An attachment as claimed in any one of claims 14 to 17, wherein the attachment structure allows rotation of the attachment relative to the mask. 19. An attachment as claimed in any one of claims 6 to 13, wherein said attachment includes attachment means for attaching said attachment to said mask. 20. An attachment as claimed in claim 19, wherein said attachment means includes at least one snap-in undercut for engaging a mating flange on said mask. 21. An attachment as claimed in claim 19 or 20, wherein said attachment means removably attaches said attachment to said mask. 22. A connector as claimed in claim 21, wherein said connecting means includes a movable portion on which said snap-fit undercut is formed, said movable portion allowing said The undercut is disengaged from said flange. 23. An attachment as claimed in any one of claims 19 to 22, wherein said attachment means enables rotation of said attachment relative to said mask. 24. A connector as claimed in any one of claims 6 to 23, wherein said connector includes a Rue opening through said channel wall. 25. A connector as claimed in any one of claims 6 to 24, wherein said vent hole walls are at an oblique angle to said air flow. 26. The connector as claimed in claim 25, wherein said angle is 25°-155°. 27. A connector as claimed in any one of claims 6 to 26, wherein the connector includes on its outer surface a recess having a wall portion extending from the outside of the vent wall. 28. A connector as claimed in claim 27, wherein said wall portion diverges in a direction away from said vent wall. 29. A mask for treating sleep-disordered breathing, said mask having a shell/cushion with inner and outer surfaces, a flange extending from said outer surface and surrounding said shell/cushion; said mask having an exoskeleton frame shaped to substantially match the contour of the flange so that when the shell/cushion is shaped for patient use, said frame can be placed adjacent to the flange, and said flange Keep the structure on the frame. 30. The mask of claim 29, wherein the means for retaining the flange to the ring member includes one or more holes through the flange. 31. The mask of claim 29, wherein rivets or other fasteners pass through said apertures to hold said flanges against said frame. 32. A mask as claimed in any one of claims 29 to 31, wherein the frame is optionally configured to be attached to a headgear to position the mask on a patient's head. 33. A mask for treating sleep-disordered breathing, said mask having a shell/cushion with inner and outer surfaces, a flange extending from said outer surface and surrounding said shell/cushion; said mask having an exoskeleton frame shaped to substantially match the contour of the flange so that said frame can be positioned proximate to the flange when the shell/cushion is shaped for patient use; and said flange A device that remains on the frame. 34. The mask of claim 33, wherein the means for retaining the flange to the ring member includes one or more holes through the flange. 35. The mask of claim 33, wherein rivets or other fasteners pass through said apertures to hold said flanges against said frame. 36. A mask as claimed in any one of claims 33 to 35, wherein said frame includes means for coupling to the headgear to position said mask on the patient's head. 37. A mask as claimed in any one of claims 29 to 36, wherein said frame includes at least one connecting member connected to the frame, the connecting member cooperating with the frame to clamp said flange between said at least one between a connecting member and said frame. 38. The mask of claim 37, wherein said at least one connecting member is hinged to said frame. 39. The mask of claim 37, wherein said at least one connecting member is connected to said frame by a flexible connection. 40. A mask as claimed in any one of claims 29 to 39, wherein the second annular member is shaped to substantially match the contour of the flange so as to clamp the flange to the first Between the ring member and the second ring member. 41. A mask as claimed in any one of claims 29 to 40, wherein said second annular member, said flange and said first annular member are secured together by rivets and/or fasteners. 42. The mask of claim 41, wherein said second annular member includes a rivet extending therefrom and passing through said flange and said first annular member. 43. The mask of claim 41, wherein said first annular member includes a rivet extending therefrom and passing through said flange and said second annular member. 44. The mask of claim 41, wherein said flange includes a first set of rivets extending forwardly and a second set of rivets extending rearwardly, said first set of rivets penetrating through said first set of rivets. A hole in a ring member, said second set of rivets driven into holes passing through said second ring member. 45. A mask as claimed in any one of claims 42 to 44, wherein said rivets are deformable at their free ends. 46. A mask as claimed in any one of claims 42 to 44, wherein said rivets include deformable undercuts such that the undercuts can pass through said apertures and then recover their shape so that the The components are fixed together. 47. A mask system comprising a headgear and a mask as claimed in any one of claims 29 to 46. 48. A mask system as claimed in claim 47, wherein said mask system comprises an attachment as claimed in any one of claims 6 to 28. 49. A mask system comprising a headgear, a mask and an attachment as claimed in any one of claims 6 to 28. 50. A mask system according to claim 1 or 2, wherein said elbow includes structure which prevents disengagement of said aperture from said clasp during normal use. 51. A mask system according to claim 1 or 2, wherein said elbow has means to prevent disengagement of said aperture from said clasp during normal use. 52. A mask system according to any one of the preceding claims, wherein said elbow or said connector has a cylindrical outlet when it is detached from said mask. 53. A mask system as claimed in claim 52, wherein said shell/cushion includes an annular flange which, when the shell/cushion is assembled with said elbow or said connector, The lip engages the edge of the spout, thereby suitably sealing the spout with the flange.

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