NZ599406B2 - Mask system - Google Patents

Abstract

599406 Disclosed is a headgear assembly for a continuous positive airway pressure or CPAP breathing mask system formed from two flat straps or material sections. The headgear assembly comprises a two-dimensional first headgear section; and a two-dimensional second headgear section. The two-dimensional first and second headgear sections are attached to one another to form a three-dimensional anatomically-shaped headgear assembly. The first and second headgear sections each include crown strap portions that cooperate to form a substantially round crown strap that cups the parietal bone and occipital bone of the patient's head in use. One of the first and second headgear sections includes bridge strap portions that provide additional stability to the crown strap. The first headgear section includes top strap portions that couple the first headgear section to a frame, and the second headgear section includes bottom strap portions that couple the second headgear section to the frame. nal first and second headgear sections are attached to one another to form a three-dimensional anatomically-shaped headgear assembly. The first and second headgear sections each include crown strap portions that cooperate to form a substantially round crown strap that cups the parietal bone and occipital bone of the patient's head in use. One of the first and second headgear sections includes bridge strap portions that provide additional stability to the crown strap. The first headgear section includes top strap portions that couple the first headgear section to a frame, and the second headgear section includes bottom strap portions that couple the second headgear section to the frame.

Description

MASK SYSTEM CROSS-REFERENCE TO APPLICATIONS This application claims the benefit ofUS. Provisional Application Nos. 60/687,453, filed June 6, 2005, 60/702,58l, filed July 27, 2005, and 60/795,562, filed April 28, 2006, each ofwhich is incorporated herein by reference in its ty.

Also, PCT Application No. , filed December 24, 2004, is incorporated herein by nce in its entirety.

FIELD OF THE INVENTION The present invention relates to a mask system for delivery ofrespiratory therapy to a patient. es of such therapies are Continuous Positive Airway Pressure (CPAP) treatment, Non-Invasive Positive Pressure Ventilation (NIPPV), and Variable ve Airway Pressure (VPAP). The therapy is used for treatment of various respiratory conditions including Sleep ered Breathing (SDB) such as Obstructive Sleep Apnea (OSA).

BACKGROUND OF THE INVENTION Mask systems form an interface between a patient and apparatus providing a supply of pressurized air or breathing gas and are hence sometimes referred to as patient interfaces. In this specification, thewords mask system and t interface will be used interchangably. Mask systems in the field of the invention differ from mask systems used in other applications such as aviation and safety in particular because of their emphasis on t. This high level of comfort is desired because patients must sleep wearing the masks for hours, possibly each night for the rest of their lives. Mask systems typically, although not . always, comprise (i) a rigid or semi-rigid portion oflen referred to as a shell or frame, (ii) a soft, patient contacting portion often referred to as a cushion, and (iii) some form ofheadgear to hold the frame and cushion in on. Mask s often include a mechanism for connecting an air delivery conduit. The air delivery conduit is usually connected to a blower or flow generator.

A range ent interfaces are known ing nasal masks, nose & mouth masks, full face masks and nasal prongs, s, nozzles &. cannulae. Masks typically cover more ofthe face than nasal prongs, pillows, nozzles and cannulae. In this specification, all Will be collectively referred to as patient interfaces or mask systems. Nasal prongs, nasal pillows, nozzles and cannulae all will be collectively referred to as nasal prongs.

An inherent characteristic of nasal masks is that they do not seal the mouth region. A number ofpatients thus find that during sleep when muscles relax, mouth leak may occur. Alternatively, some patients are naturally mouth breathers and thus find a nasal mask type patient interface ineffective. MOuth leak is undesirable as, among other difficulties, it may result in noise, increased treatment pressure to compensate for the leak or an increased load on the nasal passages and potentially nasal obstruction or a runny nose. Full face masks or nose & mouth masks address this issue by sealing around both the nose and the mouth.

Leak is a problem common to all designs ofpatient interface. Since nasal bridge anthropometry varies y between patients, the soft patient contacting portion or cushion must adapt to the shapes of individual patients; Typically, this is not achieved for the entire range of ts and some form of leak occurs. The problem is ened during sleep when the jaw moves and the head position changes. This action can often serve to dislodge the mask and cause leak. Since leak can be noisy and results in less-effective treatment, users often compensate by tightening the headgear more than is desired. This is detrimental for patient comfort and can cause skin breakdown or irritation.

A further problem encountered by patients who are using filll face, nasal or nose and mouth masks is that the portion of the patient interface that seals around the nasal bridge prevents the t from wearing cles. Additionally, it may give the sensation ofbeing closed in, leading to a g of claustrophobia, particularly when combined with a mouth-sealing portion. A further disadvantage is that any leaks that may occur can affect the sensitive area surrounding the eyes.

Thus, there is a need for an improved mask system that does not suffer fi'om the mentioned drawbacks.

SUMMARY OF THE INVENTION A mask system in accordance with a first aspect of the invention provides unobtrusive, comfortable, quiet, effective. therapy to a patient's mouth and nasal passages. In mask one form, this is achieved by providing a mouth cushion With nasal prongs having a frame held in a stable position by a headgear including stabilizing elements. The headgear . according to an embodiment of the present invention uniquely provide unobtrusive sealing for both the nose and mouth. The nasal prongs and mouth 'cushion according to an embodiment of the present invention can accommodate and seal with a wide range of different facial shapes. A vent according to an embodiment of the present invention provides quiet washout of exhaled gases. A ing elbow according to an embodiment of the present invention incorporates an anti-asphyxia valve that is effective and simple to use.

A form ofheadgear in accordance with an embodiment ofthe invention es a sealing or retaining force against the mouth and against the nares. In one form the headgear includes a stabilizing element that has a generally serpentine shape that allows a ing force be ed against the nares and allows the headgear to circumvent the eyes.

A form ofnasal prong in accordance with an embodiment of the invention has base an articulated base region and an articulated head region. In one form a prong includes a region having two joints and a head region having two joints.

A nasal prong in accordance with an embodiment of the invention includes a orming portion and a structure-defining portion. In one form the prong has dual walls sing a thin seal-forming wall and a thicker structure-defining wall. r aspect of the present invention s to a mask system for use between a patient and a device to deliver a breathable gas to the patient. The mask system includes a mouth n, a pair ofnasal prongs, an elbow, and a headgear assembly. The mouth cushion is structured to sealingly engage around an exterior of a patient's mouth in use, and the pair of nasal prongs are structured to sealingly icate with nasal es of a patient's nose in use. The elbow delivers breathable gas to the patient. The headgear assembly maintains the mouth cushion and the nasal prongs in a d position on the patient's face. The headgear assembly provides a substantially round crown strap that cups the parietal bone and occipital bone of the patient's head in use. In an embodiment, the headgear assembly is constructed from two-dimensional first and second headgear sections that are attached to one another to form a three-dimensional ically-shaped headgear assembly. r aspect of the present invention relates to a mask system for use between a t and a device to deliver a able gas to the patient. The mask system includes a mouth cushion, a pair of nasal prongs, an inlet conduit, and a headgear assembly.

The mouth cushion is structured to sealingly engage around an exterior of a t's mouth in with nasal passages use, and the pair of nasal prongs are structured to sealingly communicate of a patient's nose in use. The inlet conduit is structured to deliver breathable gas to the The headgear assembly maintains the mouth cushion and the nasal prongs in a , patient. desired position on the patient‘s face. The headgear assembly es a er that retains the inlet conduit so that the inlet conduit extends up and around the patient‘s ears in use.

Another aspect of the invention relates to a headgear assembly for a mask second system including a mensional first headgear section and a tWo-dimensional headgear section. The two-dimensional first and second headgear sections are attached to one another to form a three-dimensional anatomically-shaped headgear ly.

Yet another aspect of the invention relates to a method for forming a headgear assembly for a mask system. The method includes forming a two-dimensional first headgear n, forming a two-dimensional second headgear section, and ing the two- dimensional first and second headgear sections to one another to form a three-dimensional anatomically-shaped headgear assembly.

Still another aspect of the invention s to a nasal prong for sealing with a nasal passage of a patient. The nasal prong includes a head portion structured to seal with the patient's nasal passage and a base portion structured to mount the nasal prong to a support structure. The base portion includes a horizontal segment, a radial t, and a vertical segment that provide the base n with a trampoline-like structure to add flexibility at base portion.

A further aspect ofthe invention relates to a mask system including a plurality ofheadgear straps, a sealing ly, and a stabilizing structure extending between'the sealing assembly and at least a selected one of the headgear straps. The stabilizing structure is substantially rigid and has a preformed three-dimensional shape substantially matching the shape of a portion ofthe patient's face.

Still another aspect of the invention relates to a sealing assembly for a mask around system. The sealing assembly includes a mouth cushion adapted to sealingly engage to the mouth an exterior of a patient's mouth in use, and a nasal prong insert provided cushion. The nasal prong insert includes a pair l prongs adapted to sealingly communicate with respective nasal passages of a t in use and a bridging strap to interconnect the pair of nasal prongs.

Still another aspect of the invention relates to a nasal prong insert including a pair l prongs adapted to sealingly communicate with respective nasal passages of a patient in use and a bridging strap to onnect the pair of nasal prongs. Still another aspect of the invention relates to a mask system for delivering breathable gas to a t.

The mask system includes a flame, a mouth cushion provided to the flame, and a pair of nasal The mouth cushion is adapted to sealingly engage prongs ed to the mouth cushion. around an exterior of a patient‘s mouth in use. The pair of nasal prongs is adapted to sealingly communicate with tive nasal passages of a patient in use. An elbow is provided to deliver breathable gas to the patient. A headgear assembly is removably connected to the frame so as to maintain the mouth cushion and the pair of nasal prongs in a desired position lower headgear on the patient's face. The headgear assembly includes upper headgear straps, and the flame, straps, upper stabilizing elements extending n the upper headgear straps and lower stabilizing elements ing between the lower headgear straps and the flame.

The upper and lower stabilizing elements are le along at least one bending plane so as to m to the shape of a portion of the patient's face.

Yet another aspect ofthe invention relates to a method for defining a cushion shape. The method includes selecting at least three points on the cushion, g coordinates for each of the at least three points, and smoothly transitioning the shape ofthe cushionbetween the at least three points along the cushion perimeter.

‘ Yet another aspect of the invention relates to a mask system ing a ity ofheadgear straps including at least upper straps, a sealing assembly, and an upper stabilizing element extending between the sealing assembly and the. upper straps. The upper stabilizing element includes an elongated element having an intermediate portion attachable to the g assembly and end portions attachable to respective upper straps.

Yet another aspect of the invention relates to an ally molded nasal prong including a first substantially —conical portion, a second substantially frusto-conical portion, and a connecting n that interconnects the first and second conical portions. The connecting portion is configured to allow the first fi'usto-conical portion to fold into a position adjacent the second frusto-conical portion to provide a dual wall construction.

Yet another aspect of the invention s to an elbow assembly for a mask system. The elbow assembly includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the ce ofpressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve. The clip member has a vertically extending rib that is located against an outer surface ofthe elbow when secured to the elbow.

The rib is adapted to prevent assembly ofthe flap portion between the rib and the outer surface.

Another aspect ofthe invention relates to a mask system including a sealing assembly having , a trampoline base provided to the prongs, headgear, and stabilizing elements between the headgear and Sealing assembly. The trampoline base allows the prongs to move axially. In an embodiment, the prongs each have dual wall construction.

Another aspect of the ion relates to an elbow ly for a mask system. The elbow assembly includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence ofpressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a sion provided to the anti-asphyxia valve. The clip member has a vertically extending rib that is located against an outer surface of the elbow when secured to the elbow.

The rib is d to prevent assembly of the flap portion between the rib and the outer Another aspect of the invention relates to a mask system for delivering breathable gas to a patient. The mask system includes a frame, a mouth n provided to the flame, a pair ofnasal prongs provided to the mouth cushion, an elbow to r breathable gas to the patient, and a headgear assembly removably ted to the flame so as to maintain the mouth cushion and the pair of nasal prongs in a desired position on the patient's face. The mouth cushion is adapted to sealingly engage around an exterior of a patient's mouth in use. The pair of nasal prongs is adapted to sealingly communicate with respective nasal passages of a patient in use. The headgear assembly includes upper headgear straps, lower headgear straps, an upper stabilizing element extending between each upper headgear strap and the flame, and a locking clip ed to each lower headgear strap that is adapted to be interlocked with a clip receptacle provided to the flame. Each upper stabilizing element is bendable along at least one g plane so as to conform to the shape of a portion of the patient's face. r aspect of the invention relates to a mask flame including a main body, a side flame portion provided on each lateral side ofthe main body, and a vent ly provided to each side flame n. Each vent assembly includes a plurality ofholes . arranged in a multi-column pattern and each column is vertically staggered with respect to one another..

Another aspect of the invention relates to a mask system for use between a t and a device to deliver a breathable gas to the patient. The mask system includes a mouth cushion structured to sealingly engage around an exterior of a patient‘s mouth in use, a pair of nasal prongs structured to sealingly communicate with nasal passages of a patient's nose in use, an elbow to deliver breathable gas to the patient, and a ar assembly to maintain the mouth cushion and the nasal prongs in a desired position on the patient's face.

The nasal prongs each include a line-like base that adds flexibility to the nasal prongs in use. t0031] Another aspect of the invention relates to a mask system for use between a patient and a device to deliver a breathable gas to the patient. The mask system includes a mouth cushion structured to sealingly engage around. an exterior of a patient's mouth in use, a pair of nasal prongs ured to sealingly communicate with nasal passages of a patient's nose in use, and a ar assembly to maintain the mouth cushion and the nasal prongs in a desired position on the patient‘s face. The nasal prongs each include at least a first line-like base that adds flexibility to the nasal prongs in use.

Another aspect of the invention relates to a mask system including a plurality ofheadgear straps, a sealing assembly, and a stabilizing element ing between the sealing assemblyand at least a selected one of the ar straps. The selected headgear Strap is adjustable with respect to the stabilizing element.

Another aspect of the invention relates to a mask system for use between a patient and a device to deliver breathable gas to the patient comprising a pair of nasal prongs . structured to sealinglycommunicate with nasal passages of the patient’s nose in use, each of said prongs including an inner wall and an outer wall spaced from the inner wall prior to use, said outer wall comprising a membrane that is thinner than the inner wall and no more than 0.65 mm thick. r aspect of the invention relates to a mask system for use between a patient and a device to deliver breathable gas to the patient. The mask system es a pair .of nasal prongs ured to sealingly communicate with nasal passages of the patient's nose in use. Each ofthe prongs es a thin membrane. The membrane has a thickness in the range of 0.1 to 0.65 mm.

Other aspects, es, and advantages of this ion will become apparent ifrom the following detailed description when taken in conjunction with the accompanying drawings, which are a part ofthis disclosure and which illustrate, by way of example, principles of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings: , [0037] Fig. 1 is a perspective View of a mask system constructed according to an embodiment ofthe present invention; Fig. 2 is a plan View of a first headgear section of a headgear ly of the mask system shown in Fig. 1; Fig. 3 is a plan View of a second headgear section of a headgear assembly of the mask system shown in Fig. 1; Fig. 4a is a plan view of the first headgear section shown in Fig. 2 and showing dimensions of an embodiment and an embodiment of instruction to form the three- dimensional first headgear section and ction where second ar section is attached; Fig. 4b is a plan View of another ment of the first headgear n; Fig. 4c is a plan View of another embodiment of the first ar section; Fig. 4d is a plan View of another ment of the first headgear section; Fig. 4c is a plan View of yet another embodiment of the first headgear section; Fig. 4f is a plan View of still another embodiment of the first headgear section; Fig. 5 is a plan View of the second ar section shown in Fig. 3 and showing diniensions of an embodiment; Fig. 6 is a perspective view of the mask system shown in Fig. I removed from the patient's head; Fig. 7a is a ctive View ofthe headgear assembly of the mask system shown in Fig. 1 with the first and second headgear sections detached; Fig. 7b is a perspective View. of the headgear assembly of the mask system shown in Fig. 1 with the first and second headgear sections attached; Fig. 8 is a rear perspective view of‘themask system shown in Fig. 1 on the patient's head; Fig. 9 is a side View of the mask system shown in Fig. 1 on the patient's head; Fig. 10 is a rear view of the mask system shown in Fig. 1 on the patient's head; Fig. 11 is a front view of another embodiment of a mask system on the patient's head with X, Y, and Z axes; Fig. 12 is a side View of the mask system shown in Fig. 1 on the patient's head With X, Y, and Z axes; . Fig. 13 is a front perspective View ofthe mask system shown in Fig. '1 on the patient's head with the patient pivoting a stabilizing or stabilizer strap; Fig. 14 is an enlarged perspective view of a frame attachment member of the mask system shovVn in Fig. 1 being engaged with an upper headgear anchor; Fig. 15 is an enlarged perspective view of the frame attachment member shown in Fig. 14 engaged with the upper headgear anchor; Fig. 16 is an enlarged perspective View of a frame attachment member of the mask system shown in Fig. 1 being engaged with a lower headgear anchor; Fig. 17 is an enlarged perspective View of the frame attachment member shown in Fig. 16 engaged with the lower headgear anchor; ‘ [0060] Fig. 18 is an enlarged perspective view of the flame attachment member- shown in Fig. 16 being removed from the lower headgear anchor; Fig. 19 is a top perspective View of an embodiment of a headgear locking clip; Fig. 20 is a bottom perspective view of the headgear locking clip shown in Fig.

Fig. 21 is a side View of the headgear locking clip shown in Fig. 19; Fig. 22 is an ed perspective view ofthe headgear locking clip shown in Fig. 19 being engaged with a clip acle on the frame; Fig. 23 is an enlarged ctive view ofthe headgear locking clip shown in Fig. 19 engaged with a clip receptacle on the frame; Fig. 24 is a perspective View of an embodiment of a mask system with headgear stabilizing straps attached via a press-stud type interface; Fig. 25 is a bottom perspective View of the mask system shoWn in Fig. 24 on the patient's face; Fig. 26 is a perspective view of an ment of a mask system with an adjustable chin support; Fig. 27 is a bottom perspective view ofthe mask system shown in Fig. 26; Fig. 28a is a side view of an ment of a masksystem with chin and cheek ts; Fig. 28b is a perspective View of the mask system shown in Fig. 28a; Fig. 29 is a rear perspective View of an embodiment of a mask system with a "scuba mas " style support; Fig. 30 is a side perspective View of the mask system shown in Fig. 1; Fig. 31 is a top View of the frame of the mask system shown in Fig. 1; Fig. ‘32 is a side View ofthe frame of the mask system shown in Fig. 1; Fig. 33 is a top perspective View of the mask system shown in Fig. 1; 'Fig. 34a is a sectional view of an embodiment of an insertable nasal - Prong; Fig. 34b is a top ctive of a mask system including a cushion having a recess adapted to receive the able nasal prong shown in Fig. 34a; Figs. 34c-1 to 340-13 illustrate the trampoline effect of the nasal prong according to an embodiment of the present invention; Fig. 34d is a cross-sectional view of a nasal prong ing to r embodiment ofthe present invention; Fig. 35 is a perspective view that illustrates an embodiment of nasal prong sizes; Fig. 36 is a perspective View that illustrates an embodiment ofnasal prong base sizes; Fig. 37 is a side View of another embodiment of a nasal prong in a free state; Fig. 38 is'a side View of the nasal prong shown in Fig. 37 in a Compressed state; Fig. 39 is' a front view illustrating the nasal prong shown in Fig. 37 engaged with the t's nose and the mouth cushion moving to the side; Fig. 40 is a perspective view of a mask system constructed according to another embodiment ofthe present invention; Fig. 41 is a front view of the mask system shown in Fig. 40; .[0088] Fig. 42 is a side view of the mask system shown in Fig. 40; Fig. 43 is an enlarged rear View ofthe mask system shown in Fig. 40; Fig. 44 is an enlarged bottom perspective view ofthe mask system shown in Fig. 43; . Figs. 45-47 illustrate a mask system according to still another embodiment of the present invention; Fig. 48 is a side View of a mask system according to another embodiment of the present invention; Figs. 49—52 illustrate a paired prong arrangement according to an embodiment of the present invention; another Figs. 52B-52E illustrate a paired prong arrangement according to embodiment ofthe present invention; I ment Figs. 53-56 illustrate a single prong arrangement ing to an ofthe present invention; Figs. 57 illustrate a prong including one or more ribs according to an embodiment ofthe present invention; ' Figs. 59-62 illustrate a prong including a single wall according to an embodiment ofthe present invention; thin wall Fig. 62B illustrates a single wall nasal prong having a relatively ofthe thickness with beading around a top section thereof acCording to an embodiment present invention; Figs. 63-65 illustrate prongs having different upper section profiles; Fig. 66 rates a prong having varying wall ns; ofthe , Fig. 66B illustrates nasal prongs according to another ment present invention; Figs. 67-70 illustrate a prong including a dual wall according to an embodiment ofthe present invention; each nasal Figs. 70B-1 to 70B-10 rate a paired—prong arrangement with to an embodiment of the present invention; prong including a all according Figs. 71-77 illustrate a molding process for. constructing a prong including a dual wall according to an embodiment of the present invention; Figs. 78-83 illustrate a molding process for constructing a prong including a dual wall according to another embodiment of the present invention; - Figs. 84-89 illustrate a molding process for constructing a prong including a triple wall according to an embodiment of the present invention; nasal Fig. 89B rates a nozzle assembly including a pair of dual-wall ofthe present invention; prongs according to an embodiment ofthe Fig. 90 is a front View of a mouth cushion according to an embodiment present invention; Fig. 91 is a front View ed's full face mask cushion; Fig. 92 is a front View of ResMed's mouth mask cushion; Fig. 93 is a comparison view between cushions of Figs. 90-92; Figs. 94-95 are side and front views of the mouth cushion shown in Fig. 90; Fig. 96 is a sectional View through line 96-96 of Fig. 95, and rates comparison between cushions shown in Figs. 97-98; Fig. 97 is a cross-sectional View of ResMed's full face mask cushion; Fig. 98 is a cross-sectional view ofResMed's mouth mask cushion; Fig. 99-100 are top and bottom view of the mouth cushion shown in Fig. 90, and rate comparison between cushions shown in Figs. 102 and 103; Fig. 101 illustrates a membrane curvature of the mouth cushion shown in Fig.

Fig. 102 is a bottom view of ResMed's full face mask cushion; Fig. 103 is a bottom cross—sectional View of ResMed's mouth mask n; Figs. 104-1 06 are cross-sectional views through the mouth cushion shown in Fig. 90, and illustrate ison between cushion shown in Fig. 108; Fig. 107 illustrates an undercushion curvature of the mouth cushion shown in Fig. 90; Fig. 108 is a cross-sectional view of ResMed's full face mask cushion; ] - Figs. 109—1 11 illustrate the width ofthe mouth cushion shown in Fig. 90; ] Fig. 111B illustrates exemplary widths of the mouth cushion shown in Fig. 1 10; Figs. 112-119 illustrate wall cross sections along the perimeter of the mouth cushion shown in Fig. 90; Fig. 120 illustrates a frame and upper and lower izing elements ofthe mask system shown in Fig. 48; Figs. 1203—1201? illustrate cushion attachment to the frame; Figs. 121-124 illustrate other views ofthe flame and upper and lower stabilizing elements; . Figs. 124B—124I illustrate s views of the frame including avent assembly according to an embodiment ofthe present invention; Figs. 125-140 illustrate an elbow assembly according to an embodiment ofthe present invention; Figs. 141-143 illustrate upper and lower headgear sections of the headgear assembly for the mask system shown in Fig. 48; Figs. 144-146 illustrate exemplary dimensions for large,lmedium, and small upper headgear sections; Figs. 147-149 illustrate exemplary ions for large, medium, and small lower ar sections; Figs. 150-154 illustrate the headgear assembly of Figs. 141-143 with upper and lower stabilizing elements led and positioned on a patient's head; Fig. 155 illustrates the mask system shown in Fig. 48 with upper and lower stabilizing elements positioned on a patient's face; Figs. 156-1 58 illustrate an upper stabilizing element according to an embodiment ofthe present invention; Figs. 158b-l to 158b-7 rate an upper stabilizing element and frame ing to another embodiment ofthe present ion; Figs. 158c—1 to 1580-4 illustrate an upper stabilizing element and frame according to' another embodiment of the present invention; Figs. 159-166 illustrate a lower izing element according to an embodiment ofthe present invention; Figs. 167-170 illustrate assembly of the lower stabilizing element shown in Figs. 6 to clip receptacles provided on the frame; 0 Fig”. 171 illustrates forces provided by the headgear assembly according to an embodiment ofthe present invention; Fig. 172 illustrates dimensional stability provided by the headgear assembly according to an embodiment of the present invention; ] Figs. 173-175 illustrate upper stabilizing ts according to alternative embodiments ofthe present invention; Figs. 176-177 illustrate alternative arrangements ofupper stabilizing elements; ] Figs. 178-1 81 illustrate a headgear assembly according to r embodiment of the present invention; Figs. 182-184 rate a lower stabilizing element according to another embodiment ofthe present invention; Figs. 185-189 illustrate a mask system according to another embodiment of the present invention; . Figs. 190-193 illustrate an elbow according to another embodiment of the t invention; Figs. 194-196 illustrate a clip member according to another embodiment of the present invention; and Fig. 197 illustrates a mouth cushion With a "boomerang profile" according to r embodiment ofthe present invention.

DETAILED PTION OF ILLUSTRATED EMBODINIENTS §1. First Illustrated Embodiment of Mask System , Fig. 1 illustrates a mask system. 210 ucted according to an embodiment ofthe present invention. As illustrated, the mask system 210 includes a sealing assembly 212 that es an effective seal with both the patient’s mouth and the patient’s nasal passages, 218 to a swivel elbow 214 to deliver breathable gas to the patient, and a headgear assembly maintain the sealing ly 212 in a desired position on the patient's face. In an embodiment, the swivel elbow 214 may be replaced with an elbow that is provided to a side of the mask system, e.g., see Fig. 11. §1.1 Headgear . § _1. 1.1 Anatomically Shaped Headgear Assembly As best shown in Figs. 2, 3, 7a, and 7b, the headgear assembly 218 includes a first headgear section 220 and a second headgear section 230 that is attached to the first headgear section 220. Specifically, the first and second headgear sections 220, 230 are constructed fiom mensional flat headgear material, e.g., soft, flexible composite al such as Breathe-O-PreneTM manufactured by Accumed logies Inc. The two- dimensional flat headgear material is stamped, cut, or otherwise manufactured fi'om a sheet, form the desired shapes ofthe first and e.g., flexible material with thickness of 0.1-3mm, to . second headgear sections 220, 230. As shown in Fig. 2 (which illustrates the first headgear section's bowed final form before it is ed to the second headgear section 230), the first headgear section 220 includes top strap portions 222, bridge strap portions 224, and crown includes a strip ro® strap portions 226. The free end of each top strap portion 222 al 228 for use in securing the upper stabilizing straps 250 to the headgear assembly 218, and thereby ng the sealing assembly 212 to the headgear assembly 218. dashed lines in Fig. 2 represent le joint locations of the first headgear section 220 to achieve its bowed three-dimension final form. As shown in Fig. 3 (which illustrates the second headgear section's final form before it is attached to the first headgear section 220), the second headgear section 230 includes bottom strap portions 232 and crown strap portions 234. The free end of each bottom strap portion 232 includes a strip ofVelcro® material 238 for use in securing the lower stabilizing straps 260 to the headgear assembly 218, and thereby securing the sealing assembly 212 to the headgear assembly 218. Figs. 2 and 3 rate the mensional first and second headgear sections 220, 230, and Figs. 4a and 5 rate ions of embodiments of the first and second headgear ns 220, 230. Although specific ions and ranges of the first and second headgear sections 220, 230 are shown ~ in Figs. 4a and 5, it is to be understood that these dimensions and ranges are merely exemplary and other ions and ranges are possible depending on application. For example, ranges that vary from those ed +/- 10% may be suitable for particular applications.

The two-dimensional first and second headgear sections 220, 230 are attached to one another, e.g., stitched, welded, glued or otherwise formed, to form a three-dimensional anatomically shaped headgear assembly 218. As shown in Figs. 4a, 7a, and 7b, the first and second headgear sections 220, 230 are attached by attaching ends ofrespective crown strap portions 226, 234. Fig. 6 rates the three-dimensional headgear assembly 218 attached to the sealing assembly 212, and Fig. 7b illustrate the three-dimensional headgear assembly 218 remOved fiom the patient's head.

As shown in Figs. 8-10, the crown strap portions 226, 234 ofthe headgear ly 218 cooperate to form a round-shaped crown strap 240 that cups the al bone and occipital bone of the patient's head. The crown strap 240 is preferably constructed fi'om at least two segments of soft, flexible material that allows the crown strap 240 to conform to the shape of the, patient's head. While the al may be non-elastic, in a preferred embodiment the material is elastic in order to further allow the headgear assembly 218 to conform to the patient's head shape and may be a‘composite material such as Breathe-O- PreneTM manufactured by Accumed Technologies Inc.

The bridge strap portions 224 of the first headgear section 220 provides additional stability to the crown strap structure and prevent buckling. The bridge strap portions 224 may be provided to the first headgear section 220 in multiple arrangements. For example, as shown in Fig. 4a, the bridge strap portions 224 may be formed, e.g., d, from the same piece of material where it remains attached between the top strap portion 222 and the crown strap portion 226. Then, the bridge strap portions 224 may be cut away from respective top strap portions 222 and moved slightly s respective crown strap portions 226 where it is reattached, e.g., see dashed lines in Fig. 4a. This arrangement assists in forming the first headgear section 220 into the three-dimensional shape.

In another embodiment, bridge strap portions 224 may not be provided on the first ar section 220 as shown in Fig. 4b. .

In another embodiment, the bridge strap portions 224 may be formed, e.g., punched, from the same piece of material and attached between the top strap portions 222 and the crown strap portions 226, and then left in its flat ration as shown in Fig. 40.

In r embodiment, the bridge strap portions 224 may be formed, e.g., punched, from the same piece of material as the top strap portions 222 and the crown strap portions 226 such that the bridge strap portions 224 are separated from respective top strap ns 222 as shown in Fig. 4d. Then, the bridge strap portions 224 are reattached to respective top strap portions 222 to form a three-dimensional shape.

In yet another embodiment, the bridge strap portions 224 may be formed, e.g., punched, separately from the top strap portions 222 and the crown strap portions 226 as shown in Fig. 4e. Then, the bridge strap portions 224 are attached between tive top strap portions 222 and crown strap portions 226 to form a three-dimensional shape.

In still another embodiment, the bridge strap portions 224 may , e.g., punched, fi'om the same piece of material as the top strap portions 222 and the crown strap portions 226 such that the bridge strap portions 224 are separated from respective crown strap portions 226 as shown in Fig. 4f. Then, the bridge strap portions 224 are reattached to respective crown strap portions 226 to form a three-dimensional shape. The bridge strap portions 224 may also be shortened (e.g., by cutting) if desired before reattaching depending on the particular application.

In still another embodiment, the strap portions of the headgear assembly may have different elasticity from one r depending on application.

However, the headgear assembly may have other suitable arrangements and forming methods. For example, the straps of the headgear assembly may be attached to one another in other locations to e-a dimensional effect.

The ar assembly 218 provides several advantages to both the manufacturer and the patient. For example, the ion of a three-dimensional crown strap of straps that is a ized 240 that fits snugly to the patient's head prevents the buckling problem with some existing headgear. This increases the patient's comfort and provides fit of the crown stability to the mask system. In addition, the stability provided by the snug have a relatively small footprint. This in turn strap 240 allows the headgear assembly 218 to the patient's head, which ses provides a relatively small surface area in contact with that press against the head when comfort of the patient, e.g., prevents heat formation, areas bulk of the headgear assembly 218. Also, being worn, sweating, etc., and reduces the visual the need to e the formation of the crown strap 240 as described above removes with existing headgear, and thus no adjustment on the headgear assembly 218 that1s known discomfort are found Further, relatively hard adjustment ents that can lead to patient the crown strap 240 provides a relatively the use of two—dimensional components to construct r, alternative methods low-cost method of cturing a three-dimensional shape. materials or foam molded headgears are ofmanufacture such as molding from heat—setting possible. bed in connection Also, although the headgear assembly 218 has been be used With the mask system 210, it is to be understood that the headgear assembly 218 may oro-nasal mask, etc. in all types ofmask systems, e.g., nasal mask1 mouth mask, §1.1.2 Substantially Rigid Stabilizing Straps As best shown in Figs. 1, 11, and 12, upper ntially rigid stabilizing of the top strap portions 222 and the sealing assembly straps 250 are provided between each 260 are provided between each of the 212, and lower substantially rigid stabilizing straps 212. The upper and lower stabilizing bottom strap portions 232 and the sealing assembly connection system between the headgear strap straps 250, 260 provide a flexible yet stable order to ensure suitable tension vectors are portions 222, 232 and the g assembly 212 in mouth and nasal passages. provided to seal the sealing assembly 212 with both the patient’s mouth region are illustrated in Fig. 171 The desired vectors to achieve a seal to the nares and for example and denoted by FM and F specifically. ed to as stabilizing ] As illustrated, the stabilizing straps 250, 260, also constructed from a rigid or semi-rigid yoke elements or ned headgear elements, are each via stitching, welding, gluing, or section 244 that is attached to a al backing 246, e.g., otherwise mechanically affixed. In the illustrated embodiment, the yoke section 244 is manufactured from nylon or polypropylene or polycarbonate. However, other materials of greater or less rigidity are also le. The stabilizing straps 250, 260 may be constructed from multiple layers, e.g., more than two layers, or may be ucted from a single layer of substantially rigid material. In an alternative embodiment, the stabilizing straps may be constructed from a relatively soft and rigid material so that a al backing is not needed.

The sectional geometry of the yoke section 244 allows flexing across the thickness, i.e., rotation around the Y-axis in Figs. 11 and 12, to conform to a patient’s face, while preventing flexing along the longitudinal axis, i.e., no rotation around the X-axis in Figs. 11 and 12 . In this way, the stabilizing straps 250, 260 act to maintain the position ofthe top and bottom strap portions 222, 232 relative to each other, and secure the mask system 210 at the correct orientation on the patient's face. In on, the izing straps 250, 260 act as “outriggers” to the mask system 210 and provide a larger footprint on the patient's face. This arrangement substantially increaSes the stability of the mask system.

Another aspect of the design of the headgear assembly 218 is the angle that the stabilizing straps 250, 260 make with respect to the g assembly 212 and the patient's face. In the rated embodiment, each ofthe upper stabilizing straps 250 makes an angle a of 40° +/— 10° with respect to the horizontal plane H (as defined in Fig. 32) ofthe sealing assembly 212 .

This angle a has been chosen as the top strap portions 222 are designed to affect sealing in the roughly orthogonal planes of the nasal openings and the mouth opening of the patient. See the vectors illustrated in Fig. 171 (i.e., along these planes). In this way, ning the top strap portions 222 will simultaneously draw the nasal prongs 270 of the sealing assembly 212 up and into engagement With the patient's nares While also g the cushion 272 of the sealing assembly 212 back and against the patient's face (particularly above the patient's upper lip). Thus, the angle chosen and the resultant force vector when headgear n is applied allows for effective sealing at both the nasal prongs‘270 and the mouth cushion 272 . The angle chosen also takes into account the various forces the mask system 210 is t to, e.g., the force desired to seal against the treatment pressure (as a function of sealing area), and the force desired to offset tube drag and other factors.

In the illustrated ment, each of the lower stabilizing straps 260 makes an angle [3 of 0° to 30° with respect to the horizontal plane H (as defined in Fig. 32) of the sealing assembly 212 . The lower stabilizing straps 260 are aligned in this manner so that the bottom strap portions 232 will extend close to the base of the patient's ear and remain ily on the bony part of the patient's skull. This arrangement minimizes the sections of bottom strap portions 232 that extend horizontally over the patient's neck. In this way, the ar assembly 218 remains firmly attached to the patient's head as there is no ve movement (e.g., distance s) between headgear components when t is moving or rolling around and therefore stability of the mask system 210 is maximized. By way of explanation, if the headgear extended over the patient's neck it wouldmove or tighten and loosen with head movements of the patient. This angle also ensures that the bottom strap portions 232 intersect with the crown strap 240 at the appropriate location at the base. of the occiput of the patient's head. § 1. 1.3 ment to Frame §1. 1.3. 1 First Embodiment ar As illustrated in Figs. 1, 11, and 12, the upper stabilizing straps 250 are removably ted to an upper portion ofthe frame 274, and the lower stabilizing straps 260 are removably connected to a lower portion ofthe flame 274.

As shown in Figs. 11 and 12, each of the upper and lower izing straps 250, 260 includes a strap attachment member 254 secured at one end and a flame attachment member 264 secured at the opposite end. The strap attachment member 254 includes crossbar that enables the end portion of the tive top and bottom strap portion 222, 232 to be wrapped around, in a known manner. The flee end of each of the top and bottom strap portions_'222, 232 includes a strip of Velcro® material 228, 238 that engages the remainder of the strap portion to adjustably pull or secure the strap attachment member 254 in place. Thus, the length of the top and bottom strap portions 222, 232 may be easily adjusted. However, other adjustment arrangements are possible, e. g., adjustment via ladderlock, ratcheting mechanism, etc.

As best shown in Figs. 1 and 13, the flame attachment member 264 of each of the upper and lower stabilizing straps 250, 260 is in the form a swivel attachment that of the upper stabilizing straps 250 is provides a post element 266. The swivel attachment 250 to rotate in one plane in order to arranged to allow respective upper stabilizing straps 13. The swivel attachment of accommodate a wide range of facial angles, as shown in Fig. for easy engagement]disengagement. the lower stabilizing straps 260 is ed to allow Specifically, as best shown in Figs. 1 and 11, the frame 274 includes a main side thereof. The main body includes an body having a side flame portion 278 on each lateral elbow 214 for delivering breathable gas. Upper aperture 280 that is coupled to the swivel side flame portion 278 thereof. As best shown lower anchors 256, 258 are provided on each the form of a female connector that provides a in Figs. 14 and 16, each anchor 256,2581s in substantiallyin line slot opening 262. Also, as shownIn Fig. 31, the upper anchors 256 are the frame 274 (see arcuate dashed line). with the prongs when the prongs are receivedin is ocked with a respective In use, each flame attachment member 264 the respective slot opening 262 anchor 256, 258 by moving the post element 266 adjacent slot opening 262, e.g., with a such that the post element 266 engages within the tive ends of the upper stabilizing straps 250 snap-fit. The flame attachment members 264 on the anchors 256 on the flame 274 (see are adapted to ably interlock with respective upper 264 on the ends of the lower izing Figs. 14—15), and the flame attachment members flame interlock with respective lower anchors 258 on the straps, 260 are adapted to releasably soft flexible finger tab 268 is ed on 274 (see Figs. 16-18). As shown in Figs. 16-18, a ofthe lower stabilizing straps 260 to facilitate the end of each flame attachment member 264 attachment member 264 to the lower anchors engagement and agement of the flame 258. 262 of respective upper anchors As shown in Figs. 14 and 15, the slot opening 212'in order to eliminate inadvertent 256 is oriented towards the flont of the sealing assembly 250 is pulling directly disengagement. When in use, the force on the upper stabilizing strap of the upper anchor slot opening 262, and up against a solid section away flom the respective 256. of respective lower anchors 258 ] As shown in Figs. 16-18, the slot opening 262 212 in order to allow for easy is oriented dicular to the flont ofthe sealing assembly 210 with a quick engagement/disengagement. This arrangement provides the mask system release system so that the mask system 210 may be removed quickly and easily flom the patient's face in the event of an emergency or panic attack, as shown in Fig. 18.

The headgear attachment points, i.e., anchors 256, 258, are located towards . the top and at the lowest point on the flame 274, e.g., see Fig. 1. This arrangement allows the stabilizing straps 250, 260 to articulate and rotate as described above, without the stabilizing straps 250, 260 having to bend as they run over the top of the flame 274. This fleedom of rotation allows the stabilizing straps 250, 260 to conform to the patient’s face. §1. 1.3.2 Second Embodiment In an alternative embodiment, the frame attachment member of each of the lower stabilizing straps 260 may be in the form of a locking clip 364. As shown in Figs. 19- flexible 21, the locking clip 364 includes upper and lower arms 365, 367 that are resiliently towards one another. Also, the upper arm 365 es spaced—apart protrusions 369. In an ment, the locking clip 364 is molded in one-piece along with the yoke n 244 of the respectiVe lower stabilizing strap 260. Alternatively, the locking clip 364 may be formed separately flom the yoke n 244 and attached thereto, e.g., by an adhesive or rotational connection, etc.

] As shown in Figs. 22-23, the flame 274 is provided with clip receptacles 371 slots 373. on each side flame member thereof. Each clip receptacle 371 includes spaced-apart In use, each clip 364 is interlocked with a tive clip receptacle 371 by first moving the clip 364 into the respective clip receptacle 371 such that the protrusions 369 extend through respective slots 373 with a snap fit. The clip 364 may be released flom the respective clip receptacle 371 by depressing the arms 365, 367 towards one another until the protrusions 369 release from the slots 373. The clip ement may provide audible feedback when the clips 364 are attached to the respective clip receptacles 371.

Also, the clip arrangement may have other suitable designs, such as those disclosed in U.S. Patent Application No. 10/390,681, filed March 19, 2003, U.S. Patent Application No. 10/655,621, filed September 5, 2003, and U.S. Patent No. 6,374,826, the ' contents of each being hereby incorporated by nce in its entirety. §1. 1.3.3 Third Embodiment ] In r alternative embodiment, the flame attachment member of each of the upper and lower stabilizing straps 250, 260 may be in the form of a preSs-stud type interface. As shownin Figs. 24-25, the end of each stabilizing strap 250, 260 es a protruding stud 465. A sofi: flexible finger tab 468 is provided on the end of each stabilizing strap to facilitate engagement and disengagement to the flame 274.

The frame 274 is provided with stud receivers on each side flame member f. In use, each stud 465 is press-fit into a respective stud receiver. This arrangement allows the stabilizing straps 250, 260 to rotate with respect to the flame 274 to allow the mask system to align on the patient's face. In an alternative embodiment, the studs 465 may be provided on the flame 274 and the stud receivers may be provided on the stabilizing straps 250, 260. § 1. 1.4 Alternative izing Systems Figs. 26-29 illustrate alternative embodiments for stabilizing the mask system on the patient's face. For example, Figs. 26-27 show a mask system 512 that es an adjustable chin support 502. As illustrated, the flame ofthe mask system 512 includes an extension 504 that supports a V—shaped chin support flame 506. The V—shaped chin support flame 506 has two spaced elastomeric chin cushion elements 508 removably attached thereto and ured to engage a patient's chin. The V-shaped chin t flame 506 is moveably mounted to the flame extension 504 to adjust the position ofthe chin cushion elements 508 relative to the patient's chin, e.g., by adjusting a‘thumb screw 509. However, the chin support 502 may be adjusted in other suitable manners, e.g., via a t-type mechanism, butterfly mechanism, push-button ement, tongue/groove arrangement, and/or gear arrangement, as described in US. Patent No. 6,532,961, incorporated herein by reference in its entirety.

Figs. 28a and 28b show a mask system 612 that includes chin and cheek supports 602, 604 integrally formed with the cushion 672. As illustrated, the cushion 672 es a chin support 602 that extends downwardly flom a lower side wall thereof. The chin support 602 is contoured to conform to the patient's chin. The cushion 672 also includes a cheek support 604 that extends upwardly flom an upper side wall thereof. The cheek support 604 is contoured to conform to the patient's cheeks.

Fig. 29 shows a mask system 712 that includes a scuba-style support 702 integrally formed with the cushion_772. As illustrated, the support 702 extends outwardly from a lower portion and side portions of the cushion 772. The support 702 is red to m with chin and cheek regions ofthe patient's face that surround the patient's mouth. §1.2 Mouth Cushion and Frame Shape As shown in Figs. 1 and 30-33, the sealing assembly 212 of the mask system 210 includes a mouth cushion 272 ured to sealingly engage around an exterior of a patient's mouth in use and a pair ofnasal prongs 270 ured to sealingly communicate with the nasal passages of the patient's nose in use and in ular the base of the patient's nares. The cushion 272 may be integrally formed in one-piece along with the prongs 270, e.g. by silicone in an injection molding process The cushion 272 is ured to be bly and replacably attached to a substantially rigid frame 274, e.g., by friction fit, mechanical fastening means, etc. Also, the frame 274 includes an aperture 280 that coupled to the swivel elbow 214 for delivering breathable gas. Further, one or more vent openings may be provided in the frame and/or swivel elbow for CO2 washout. For example, Figs. 1, 11, 12, and 32 illustrate the frame 274 including a vent 281. The vent 281 may have a similar form to those disclosed in US. Provisional Patent Application No. 60/643,114 to Veliss, filed January 12,‘ 2005, the contents ofwhich are hereby orated by reference in their entirety.

In an alternative embodiment, as shown in Fig. 11, opposing ends ofthe mask system may include cylindrical tubes 282, one ofwhich may be provided with a plug or vent and the other ofwhich may be provided with an elbow 214 for delivering breathable gas. The positions of the elbow and plug/vent may be interchanged, depending on patient ence.

Also, in another embodiment, the mask system (with or without cylindrical tubes 282) may be ventless such as the ventless design described 1n U. S. Patent Application No. 60/667,052, filed April 1, 2005, the contents of which are hereby orated reference1n its ty.

A low profile1s provided by sweeping back the frame 274 immediately around the prongs in order to achieve frame attachment points 256, 258 as close as possible to the face without touching the lips. In a preferred embodiment as shown in Fig. 31, the frame 274 is swept back in side frame portions 278 of the flame 274 such that these side frame portions 278 are about 15+/-5mm below the frame height at which the frame 274 receives the prongs, i.e., the region 276. This arrangement improves the mouth cushion height to depth ratio and reduces the height ofthe mask system 210 on the patient's face. In addition, this arrangement allows the headgear attachment points 256, 258 to be as close as possible to the patient’s face.

Both of these factors combine to improve stability ofthe mask system 210.

Fig. 33 illustrates the position of the upper headgear anchors 256. As illustrated, the axis A between the centers of the upper anchors 256 lies centrally between the nasal prongs 270 and the upper sealing surface of the mouth cushion 272. This lized location enables the headgear vector to radiate from these points in an orientation that is optimized for sealing both the nasal prongs 270 and mouth cushion 272. That is, the chosen comfortable vector achieves a good balance in compressing the nasal prongs 270 to e a seal in the nose and compressing the mouth cushion 272 to achieve a comfortable seal at the mouth. Concurrently, this vector orientation and on is in a plane such that the headgear stabilizing straps 250, 260 achieve a tangential point of contact with the cheek region on the patient‘s face. This is advantageous for comfort.

Also, the use of a low profile cushion 272 uses less silicone, which effectively reduces the weight of the mask system 210. Further, the low profile design has the additional benefit ofreducing the total internal deadspace volume of the mask system 210. §1_.3 Nasal Prong Design The nasal prongs 270 may be formed separately from the n 272, e.g., fi'orn silicone in an ion molding s, and then inserted and d to the cushion 272. However, the nasal prongs 270 may be constructed from other suitable materials, e.g., gel material. This ement provides a r scope of patient fitting by being able to select cushion size and nasal prong size independently. Also, the nasal prongs 270 may be ndently aligned (i.e., by rotation of the prongs) with respect to the. cushion 272 for optimal fit.

Fig. 34a shows an embodiment of an insertable nasal prong 270. As illustrated, the nasal prong 270 is a single prong that includes a nasal portion 284 that sealingly engages with a respective patient naris or nostril and a base portion 286 that is mountable to the cushion 272, e.g., via an annular recess. For example, Fig. 34b illustrates a cushion 272 with an r recess 273 adapted to receive the base portion 286 ofthe prong 270 therein. The base n 286 ofthe prong 270 may be secured within the recess 273 via a press-fit or glued butt joint, for example. The single prong arrangement is advantageous because it allows customization of fit, e.g., more angular ment ofthe prong to match nasal angle and possibility of different sizes in each patient nostril. In an ative embodiment, the prongs 270 may be provided as a pair with a thin silicone section joining the prongs at respective base portions 286. The paired-prong arrangement may e usability, e.g., improved ease of assembly and alignment.

In the illustrated embodiment, the nasal prong 270 includes a line-like detail at both top and bottom horizontal segments 291, 290 ofthe nasal column 288. As rated, the sectional thickness, e.g., nominally 0.75mm, of the nasal portion 284 and nasal column 288 is maintained for a zed area at the base portion 286 ofthe prong 270, i.e., where the nasal column 288 meets the base portion 286 (either the cushion in the case of an integral assembly or the base portion in the case of insertable prongs), before transitioning into the base portion 286, e.g., nominally >1 .Smm. This section (indicated by horizontal segment 290, radial segment 292, and vertical segment 294) acts as a line in use. In the illustrated embodiment, the size and shape (outline) ofthe trampoline—like base is closely d, e.g., identical or close to identical in size, to that of the outer periphery 295 ofthe nasal portion 284. When the nasal prong 270 is brought into contact with the patient's nose, compression (nasal portion 284 will m0ve towards base portion 286) will occur. Nasal compression is effectively the result of the nasal column 288 ng (rolls back onto itself) - into both the nasal portion 284 and base portion 286. Because the thickness of these horizontal sections at the top 291 and bottom 290 of the nasal column 288 are identical, the , nasal column 288 will recede by a similar degree at both ofthese locations.

The inclusion of the trampolineelike detail at the top and base ofthe nasal column 288 has a two-fold effect. First, the increased flexibility at the top and base of the nasal column 288. allows these transitions to act much like a ball-in—socket arrangement. This allows increased articulation of the nasal prong 270, thereby allowing a greater range of naso- labial angles to be matched. Second, the compression at the top and base of the nasal column 288 will act as a form of sion. In this way, the mouth cushion 272 can move away from the nasal prongs 270, e.g., move downward or side to side, without disrupting the seal at the patient's nose. As the mouth cushion 272 moves, the nasal prongs 270 can uncompress while still maintaining sufficient load and hence seal at the patient's nose.

] In an alternative embodiment, the prong design may be modified to remove the radial and vertical ts 292, 294. However, the inclusion of these ts is preferred as they ze the trampoline effect.

Figs. 340-1 to 340-13 illustrate the trampoline effect of the nasal prong in greater detail. Figs. 340-1 and 34072 illustrate the nasal prong in its free state. As illustrated, the nasal prong includes a nasal or head portion 284 (also referred to as a pillow), a column or stalk 288, a base portion 286 cormnunicated with the mouth cushion volume 287, an upper trampoline base 297, and a lower trampoline base 299. The stalk 288 transitions into the upper and lower trampoline bases 297, 299 with radius R1.

As shown in Fig. 34c-3 and 340-4, when the pillow 284 linearly compresses, the upper trampoline base 297 extends into the pillow’s head portion and the lower trampoline base 299 extends into the mouth cushion volume 287. The overall effect is that the trampoline bases 297, 299 flex sufficiently so that the head n of the pillow 284 can adjust to a height and angle to fit most ls. The change in height may be represented as H t in free state) minus h (height in compressed state).

This flexing increases the length of the respective trampoline bases as shown in Fig.- 34c—5. Specifically, L1 represents the stalk 288 and trampoline base 299 in its free state, and L2 represents the stalk 288 and trampoline base 299 in its compressed state. As illustrated, the length Le2 ofthe trampoline base in its compressed or flexed state is greater than the length Lel ofthe trampoline base in its free state. The extra material required to increase the length of the line bases comes from the following isms: the trampoline base silicone stretching, and the stalk’s end rolling over and being drawn into the trampoline base as shown in Figs. 34c—6 (showing upper trampoline base 297 in its free state) and 340-7 (showing upper trampoline base 297 in its compressed state).

When The stalk 288 has an elliptical section which does not readily roll over. roll over does occur, resistance to this deformation will act against the stalk 288. Figs. 340-3, when the stalk 288 rolls 34c-4, 34c-5, and 34c-7 illustrate the mechanical ons that occur over; As illustrated, the transition radius between stalk 288 and trampoline base 297, 299 ofthe radius increases to R2 due to the flexible nature of the silicone. As a consequence in Figs. 340-1 increasing, the stalk 288 will get thinner, e.g., reduce from D to d as illustrated in the case of an to 34c-7. The stalk will thin more y in its weakest plane, which elliptical stalk is its minor axis. Also, Figs. 34c—6 and 34c-7 provide dots DT to show how material moves into the trampoline base. In addition, Fig. 34c-7 shows roll-over action AC and roll—over reaction RE that pulls in the stalk 288.

As shown in Fig. 34c-1, the stalk 288 is a l tube that merges at ofthe degrees into the trampoline bases 297, 299 which are conical es. The nature member and the adjacent trampoline geometry dictates that the stalk 288 is a relatively rigid and 340-9, when a bases 297, 299 are relatively flexible members. As shown in Figs. 340-8 rotational non—axial force F is applied to the head portion of the pillow 284 creating a the trampoline base movement to the pillow 284, the pillow 284 will react in such a way that stalk 288. or bases 297, 299 will rotationally flex around the relatively rigid Fig. 34c-8 34c—9 illustrates the upper trampoline base 297 rotating about the stalk 288, and Fig. the stalk 288. illustrates the upper and lower trampoline bases 297, 299 rotating about The trampoline base flexing is a combinatiOn of one side stretching and 340—10 illustrates other side buckling according to the ion of rotation. For example, Fig. about hing S and buckling B ofthe lower line base 299 as the stalk 288 rotates axis AR. Therefore, the stalk to trampoline base intersection acts as a junction for articulation.

A trampoline base 297, 299 ed at the top and bottom of the stalk enables the head n of the equips the pillow 284 with two articulation junctions, which pillow 284 to align to most patient nostrils. . both In most instances ofmask , the pillows 284 will be subjected to compression and rotation in order for the head portion of the pillow 284 to adjust in height and angle to conform to the patient's nose and attain seal. The trampoline bases 297, 299 will unison. therefore experience the compression and rotation actions mentioned above in Figs. and rotation scenarios for the pillow 34c-11 to 340-13 illustrate some possible compression and head portion rotated 284. For example, Fig. 34c-ll illustrates the pillow compressed about the stalk. Fig. 340-12 illustrates the g the upper line base 297 to rotate the stalk to rotate about top and pillow compressed and head portion translated causing and head bottom trampoline bases 297, 299.. Fig. 340-13 illustrates the pillow compressed bases 297, 299 to rotate about the stalk. portion rotated causing upper and lower trampoline be provided to a base of In an alternative embodiment, a leaf spring 300 may The leaf spring 300 may provide substantially the nasal prong 270 as shown in Fig. 34d. sections 292 and 294 shown above in Fig similar movement and force that is provided by 34a, e.g. lower trampoline base. §1.3.1 Nasal Prong Sizes nasal prongs 270 are provided as a In a preferred embodiment, the insertable of a number of different nasal prong , pain, Moreover, the pair may be provided in any one shown in the sizes and may be anatomically shaped. In Figs. 35-36, the nasal prongs 270 are mouth cushion 272. In on, the section position they would take when led on the For each ofthese sizes, the spacing between that mayjoin each pair together is not shown. nasal portions 284 the two nasal portions 284 is substantially the same, even though the illustrates three ent sizes of themselves are ofdiffering sizes. For example, Fig.

As illustrated, the size of the nasal ns nasal prongs 270, i.e., small, medium, and large. nasal portions 284 remains the same. 284 changes, but the spacing between the base matches that of the outer [002061 Also, as noted above, the size of the trampoline In order to allow all insertable prong ery 295 of the nasal n 284 (see Fig 34a). each size ofprong has the same overall sizes to interface with an identical mouth cushion, in dashed lines with diameter D in Fig. 36) base size. The overall base size 296 ated size 296 is the mouth cushion 272. The overall base the connector or plug that interfaces with shown in Fig. 36. For the large size, the designed to accommodate the largest prong size, as and medium ofthe overall base 296. For the small axis of the prong 270 aligns with the axis is progressively offset toward the sizes, the axis of the prong 270 (and trampoline base) between the nasal portions is identical centerline of the prong set so that the separation section on the base that remains may be (Offset — L = 0 < Offset — M < Offset — S). The greater than about 1.5mm as above. This ensures that the trampoline base works similarly or identically for all sizes. §1.3.2 Nasal Prong with Articulating Portion ] As shown in Fig. 37, the nasal prong 270 may include an articulating portion 201, or double prong configuration, to add flexibility and articulation of the nasal prong 270 with respect to the cushion 272. In the illustrated embodiment, the nasal prong 270 is structured such that it is partially "nestable" or significantly compresses once positioned in the patient's nose. For e, Fig. 37 illustrates the nasal prong 270 in a free state and Fig. 38 illustrates the nasal prong 270 in a compressed state.

In an embodiment, compression ofthe nasal prong 270 may be ofthe order of about 40%. To achieve this, the articulating portion 201 is structured such that it has a substantially horizontal lower wall 202. That is, the lower wall 202 ofthe articulating portion 201 is perpendicular to the lower column 203. This allows the prong 270 to compress as the lower column 203 moves into the articulating n 201. The nasal n 284 and upper column 204 ofthe prong 270 are similarly structured although these are marginally stiffer than the articulating n 201 and lower column 203. This bias allows the lating portion 201 and lower column 203 to ss more readily than the nasal portion 284 and upper column 204, although compression ofboth sections does occur. The upper portion 205 ofthe articulating portion 201 is designed to odate the compression ofthe lower column 203, i.e.-, there exists sufficient height in the upper portion 205 of the articulating n 201 so that the lower column 203 can move into this region. In an embodiment, the articulating portion 201 is structured such that it does not inflate and operate in an extended manner.

The selected geometry of the articulating portion 201 allows the prong 270 to compress when inserted into the patient's nose. Due to the elastic properties of the silicone (or other compressible material), this compression results in a load that assists in sealing at the patient's nose and is reacted at the frame. In effect, the prong 270 acts as a spring.

The articulating portion 201 allows additional articulation of the prong 270 ve to the flame 274 and mouth cushion 272. In operation, the lower column 203 201 as shown in Figs. 38-39. In this way, this compresses into the articulating portion of this ement is such articulating portion 201 acts as a ball-type joint. The ry undeformed with the prong 270 that the upper and lower columns 204, 203 remain essentially 204 and the lower wall 206, and the lower pivoting at the junction between the upper column lower column 203 and the lower wall 202. Further, the prong 270 is ured such that the 204. This arrangement ensures that the column 203 is initially aligned with the upper column be effectively transferred via the load desired to seal the prong 270 at the patient's nose can headgear attached to the frame. effect, Also, the compressed prong 270 acts to provide a suspension-type from the similar to that used1n vehicles. In this way, the mouth n 272 can move away side to side, without disrupting the seal at the patient‘s prong 270, i.e., move downward or the prong 270 can uncOmpress while still nose. As the mouth cushion 272 moves, maintaining sufficient load and hence seal at the t's nose (see Fig. 39). 284 and the articulating In the illustrated embodiment, both the nasal portion The shape of the nasal portion 284 ensures portion 201 have a substantially elliptical shape. loading into the patient's substantially even loading across a lower surface, and hence even the articulating portion 201 is also elliptical in shape so nose. This arrangement dictates that 284. However, the prongs 270 may that the load is transferred evenly to the nasal portion other closed section. have any other Suitable shape, e.g., circular or any Mask system §2. Second Illustrated Embodiment of §2.1 General , constructed according to another Figs. 40-44 illustrate a mask system the mask system 10 includes a g embodiment of the present invention. As illustrated, and the patient’ s seal with both the t’ 5 mouth assembly 12 that provides an effective and a structured to deliver breathable gas to the patient, nasal es, inlet conduits 14, 16 12 in. a desired position on the headgear assembly 18 to maintain the sealing assembly patient's face. mouth covering assembly 20 having a The sealing assembly 12 includes a and a exterior of a t's mouth in use cushion 22 structured to sealingly engage around an with ofnasal prongs 26 structured to sealingly engage nasal prong assembly 24 having a pair the nasal prong in use. As illustrated in Fig. 40, the nasal-passages of the patient's nose In an ofthe mouth covering assembly 20. assembly 24 is supported by a side wall 32 with is integrally formed in ece along embodiment, the mouth covering assembly However, the silicone in an injection molding process. the nasal prong assembly 24, e.g., by 24 may be formed separately from mouth covering assembly 20 and nasal prong assembly to one another. Advantageously, a stande mouth cushion size one another and then attached costs since the with a variety of nasal prong sizes reducing can be used in conjunction not be as ive as multiple multiple moldings d for different sized prongs may moldings for different sized mouth cushions. nasal prong assembly 24 include tubes 28, As illustrated, opposing ends of the inlet conduits 14, 16, e.g., via that are adapted to engage respective e.g., cylindrical tubes, cross-sectional conduits 14, 16 may have any suitable friction fit. The tubes 28 and inlet n, etc. In use, the inlet conduits 14, 16 are shape, e.g., cylindrical, elliptical, flatter via an air delivery device, and the supplied with breathable gas under pressure, e.g., ends of the nasal prong assembly 24 via pressurized breathable gas isdelivered into opposing be coupled and nasal prong ly 24 may the tubes 28. The mouth ng assembly each of these. This allows gas to be red such that gas is allowed to pass between Alternatively, the gas may be allowed to pass both the patient's nasal passages and mouth. nasal such that gas is red to only the patient's through the nasal prong assembly 24 only, passages. In this arrangement, the mouth covering assembly 20 just acts as a mouth seal. In another embodiment, the gas may be allowed to pass h the mouth covering assembly 20 only, such that gas is delivered to only the patient's mouth. In this arrangement, the nasal prong assembly 24 is d and just acts as a nasal seal.

As best shown in Figs. 43 and 44, the cushion 22 includes a non-face- contacting portion and a face-contacting portion. The non-.face—contacting portion includes a front wall 30 and a side wall 32 extending away fiom the fiont wall 30. The front and side walls 30, 32 define a chamber for receiving the t's mouth and a breathable gas when communicated to the nasal prong assembly 24. Also, opposing sides of the cushion 22 include a crossbar 34. Each crossbar 34 extends from the side wall 32 and is adapted to ably engage a lower strap of the headgear assembly 18.

] The face-contacting portion ofthe cushion 22 es a ne 36 that extends from the side wall 32. The membrane 36 is structured to form a seal around the lips of a patient. The face-contacting portion is contoured to follow generally the curvature of the t's face. The face—contacting portion may include one or more undercushions 35 (see Fig. 43) to provide a support structure for the membrane 36. In an embodiment, the undercushion 35 may have a similar form to those disclosed in US. Patent No. 6,701,927, the contents ofwhich are hereby incorporated by nce in its entirety.

The side wall 32 of the cushion 22 supports the nasal prong assembly 24. As illustrated, the nasal prong ly 24 includes a hollow body 3 8 that defines an air chamber, rical tubes 28 extending from the body 38, and a pair ofnasal prongs 26 supported by a substantially flat rear wall 37 of the hollow body 38. Each nasal prong 26 is substantially oval in cross-section and includes a flange or widened portion 40 (also referred to as heads) at an upper end thereof (see Fig. 44). The nasal prongs 26 may be angled with respect to the rear wall 37 to properly position the nasal prongs 26 with the nasal passages of the patient.

In the illustrated ment, the nasal prongs 26 are in the form ofnasal inserts. In use, the nasal prongs 26 are inserted into the patient's nasal passages and retained therein by respective flanges 40. One or more vent ports 27 may be provided in a front wall 39 of the body 38 for CO2 washout. In an embodiment, the nasal prong assembly 24 and nasal prongs 26 thereofmay have a similar form to those disclosed in US. Patent Nos. reference in their ofwhich are hereby incorporated by 6,478,026 and 6,595,215, the contents cannula, be1n the form of nasal pillows, nozzles, entirety. However the nasal prongs 26 may the patient's nasal passages in any nasal puffs, and may sealingly engage with manner. assembly 24 may include one or As noted above, the body of the nasal prong in the side wall of the more openings that icate with one or more gs provided 38 to the from the air chamber defined by the body cushion 22 to allow breathable gas to pass air chamber defined by the mouth covering assembly of the mouth cover assembly 20 In the illustrated embodiment, the components from a substantially soft material, e.g., and the nasal prong ly 24 are constructed certain components may be ucted silicone, and may be integrally formed. However, such as the front wall 30, side wall 32, from a substantially rigid or semi-rigid material, the mouth ng assembly 20. ars or rigid mounting loop 34 of §2.2 Headgear Assembly assembly 18 includes an upper As best shown in Figs. 40 and 42, the headgear connectable to the sealing assembly 12. Specifically, Fastening of the upper strap 42 to the patient's patient's forehead and above the patient's ears. material, e.g, Velcro®. The upper strap head may be provided by a hook and loop the patient's ears in use. As illustrated, includes tube retainers 46 that are positioned adjacent conduits 14, 16 inlet conduits 14, 16 so that the inlet the tube retainers 46 retain tive 46 is a In an embodiment, each tube retainer extend up and around the patient's ears. and upper strap 42. the respective inlet conduit 14,16 Velcro® strap thatIS wrapped around neck and below the patient's The lower strap 44 extends around the patients crossbar 34 lower strap 44 are wrapped around a respective ears. End portions of the by a hook and loop material such as ed on the cushion 22 and fastenedin place, e.g., other be attached to the cushion 22in any Velcro®. However, the lower strap 44 may 44 may be suitable manner, e.g., via a clip arrangement. Also, the upper and lower straps 42, joined to one another, e. g., joined to one another at the back of the patient‘s head similar to the arrangement shown in Fig. 10. §2.3 Low Profile ] As best shown in Fig. 42, the sealing assembly 12 has a low profile which improves the comfort level ofthe patient, and reduces the forces which may tend to pivot sealing assembly 12 relative to the patient’s face. §3. Third Illustrated Embodiment of Mask system Figs. 45-47 illustrate a third embodiment of a mask system 410 according to the present invention. Mask system 410 is similar to the mask systems described above, and even includes common elements that have been indicated with similar reference numbers.

For example, mask system 410 includes a sealing assembly 412, a swivel elbow 414 and a headgear assembly 418.

The overall ecture of the headgear straps in Figs. 45-47 is similar to the l architecture of the headgear straps in Fig. 12. However, one main difference in the embodiment of Figs. 45—47 relates to the use of a stabilizing structure 475. The stabilizing ure 475 in this example has one end connected to attachment member 464 provided to the flame and a second end that extends toward top strap portion 422. The second end may be connected to a tab or extension ofupper strap ment member or buckle 454. The stabilizing structure 475, attachment member 464, and buckle 454 may be integrally as a one- piece structure. atively, the stabilizing ure 475, attachment member 464, and buckle 454 may be formed separately from one another and then assembled to one another.

Stabilizing structure 475 has a “3D” form and is contoured to sit more flush with the face. In one e, the stabilizing structures are generally “S—shaped”, and extend from the patient’s temple, along the. cheekbones and towards the attachment members 464.

The shape also helps to move the stabilizing structure away from the patient’s eyes. e they are generally rigid, stabilizing structures 475 can be ly spaced from the patient’s cheek region, if desired. The stabilizing ures may be made of any rigid or semi-rigid al, e.g., polycarbonate, nylon. The stabilizing structures 475 can also be made of clear material, to minimize obtrusiveness to the patient.

Headgear assembly may include a padded material or soft portion 477 positioned between the stabilizing ure 475 and the patient’s face. However, the stabilizing structure 475 may be constructed of a relatively soft material and therefore a padded material may be unnecessary.

Mask system 410 includes a plurality of flame attachment members 464. The flame attachment members 464 associated with the top strap portions are similar to those shown in Figs. 14 and 15. The frame attachment s associated with the bottom strap portions are similar to those shown in Figs. 22 and 23.

Fig. 47 also depicts an oxygen 3. ports cap 483 for selective attachment of delivery cannulae or the like. §4. Fourth Illustrated Embodiment of Mask system §4.1 General ment of the Fig. 48 rates a mask system 1010 according to another elements that are similar present invention. The mask system 1010 may include one or more the mask system 1010 includes to those ofthe mask systems described above. As illustrated, seal with both the patient’s mouth and the a sealing assembly 1012 that es an ive and a headgear patient’s nasal passages, an elbow assembly 1014, e.g., swivel elbow, the patient's assembly 1018 to maintain the sealing ly 1012 in a desired position on which is face. The mask system 1010 enables the ry oftherapy in a manner unobtrusive, quiet, comfortable, and effective. mouth cushion The sealing assembly 1012 of the mask system 1010 es a mouth in use and a pair 1072 structured to sealingly engage around an exterior of a patient's nasal passages of the ofnasal prongs 1070 structured to sealingly communicate with the and replacably attached patient's nose in use. The cushion 1072 is structured to be removably to a substantially rigid frame 1074. §4.2 Nasal Prongs The nasal prongs 1070 may be formed separately from the cushion 1072, e.g., and secured to the cushion by silicone in an injection molding process, and then inserted able to select 1072. This arrangement provides a greater scope ofpatient fitting by being cushion size and nasal prong size independently. other It should be understood that nasal prongs, nasal pillows, nozzles, or device that go up of seal near the patient's nose may be used. In addition, most people can ofnasal prong. obtain a good nasal seal with at least one ofthree different sizes r, cushion that seals d of a pair of nasal prongs (one for each nostril), a single sealing around, e.g., just under, both nostrils may be used. §4.2. 1 -Prong Arrangement Figs. 49-52 illustrate a paired-prong arrangement wherein nasal prongs 1070 ' are provided as a pair on a single insert. As illustrated, each nasal prong 1070 includes nasal portion or head portion 1084 adapted to sealingly communicate with a respective patient nasal passage and a base portion 1086. The tip of each prong 1070 is slightly inserted into the nose, with the head n 1084 engaging the patient's nare. Each head portion 1084 includes a curved area 1085 that provides lift or spring to the head portion 1084. The prongs l070 are joined at respective base portions 1086 by a bridging or connecting strap 1088, e.g., thin silicone section. {00236} The base portions 1086 are adapted to be mounted to the cushion 1072, e.g., via an annular recess that defines a mounting flange. For example, Fig. 99 illustrates n 1072 with spaced-apart annular recesses that define flanges 1073 adapted to engage a tive groove provided in each of the base portions 1086 of the prongs 1070 n.

Each base portion 1086 may be secured within a respective flange 1073 via a interference-fit or adhesive such as glue, for e. The base portions 1086 are mounted from the ing r side of the cushion 1072 such that the bridging strap 1088 extends along an interior surface of the breathing chamber.

The paired-prong arrangement provides head portions 1084 that are pre— aligned with respect to one another. For example, each head portion 1084 has a general oval- shape with an oval-shaped nasal opening (see Fig. 50). The pair ofhead portions 1084 may be angled with t to one another to provide a better fit with the patient's nares. As shown in Fig. 50, the head portions 1084 may define an angle A therebetween of about 50°- 60°, e.g., 54°. However, other angles are possible and may be customized based on the patient. The paired-prong ement provides correct alignment with the mating cushion 1072 and with the patient‘s nares. Specifically, the head portions 1084 are pre-angled to match the patient's nares, the base portions 1086 match the oval shape ofthe flanges 1073, and the connecting strap 1088 may flex or bend to find its position.

In an alternative embodiment, as shown in Figs. 52B—52E, the major axes of ' the ical head portions 1084 may be parallel to each other, e.g., molded parallel to one another. The bridging strap 1088 may have a circular section (see Fig. 52D). When assembling the prongs 1070 onto the cushion 1072, the patient must align the prongs 1070 at to achieve the The ng strap 1088 is flexible or bendable an angle as shown in Fig. 52E. allows for either the left or right prong, which desired angle. The patient can vary the angle individual left and right prongs 1070 from customization. The bridging strap 1088 prevents and right prongs 1070 becoming ted and lost. Also, the symmetrical design (as the lefi This arrangement also allows enables easier assembly onto the cushion. are molded el) from different orientations, one being rotated 180° the insert to be inserted into the cushion in with the mating ] The paired-prong arrangement provides correct alignment each prong is held in angular alignment cushion 1072 and with the patient‘s nares because Also, the nature of its connection with the other prong. 2 with respect to the other prong by loss of component, e.g., loss of nasal . paired-prong arrangement prevents accidental of assembly. In an embodiment, in addition, the -prong arrangement may improve ease into the the paired-prong insert can be inserted the prongs 1070 may be configured such that side or the outward facing side, for error cushion 1072 in from either the breathing chamber proofing. §4.2.2 Single-Prong Arrangement wherein a nasal prong 1070 Figs. 53-56 illustrate a single-prong arrangement the cushion 1072. Similar to the above, the nasal is molded and assembled individually to to be mounted to head portion 1084 and a base portion 1086 adapted prong 1070 includes a adhesive. the cushion 1072, e.g., via a press-fit or because it allows customization The single prong arrangement is advantageous to the 0 may be independently aligned with respect of fit. For example, each nasal prong 107 of each prong to match nasal angle. cushion 1072 for optimal fit, e.g., angular ment each the possibility of different prong sizes in Also, the single prong ement provides and small prong size for right nare. patient nare, e.g., large prong size for left nare §4.2.3 Nasal Prong Ribs As shown in Figs. 57 and 58, one or more ribs 1090 may be integrally molded with each nasal prong 1070 to provide axial and radial spring and/or lateral/circumferential structural rigidity/reinforcement, e.g., increased radial strength.

In the rated ment, multiple ribs 1090 are located internally on the upper n of the nasal portion or head n 1084. The multiple ribs 1090 provide increased radial strength to allow the use of thin walled head portion 1084 without collapsing.

In this way, the head portion 1084 can inflate to a certain degree, to match nasal opening shape, but still retain sufficient rigidity to allow insertion into the nasal opening. Each rib 1090 may be attached or unattached at its base (adjacent the curved area 1085) to control spring rate and stiffness. Also, the cross-sectional thickness of each rib 1090, e.g., rib , may vary along its length to control spring rate and stiffiiess. Clearly, ribs are particularly advantageous where the cushion is formed from a very thin and/or very flexible membrane; §4.2.4 Single- Wall Nasal Prong Figs. 59-62 illustrate another embodiment of a nasal prong 1070 having a single-wall head portion 1084. As illustrated, the base portion 1086 of the nasal prong 1070 includes a slot 1092 to facilitate assembly to the n 1072. In addition, the upper flange that defines the slot 1092 (e.g., a circumferential groove) includes a curved exterior surface 1094, and the lower flange that defines the slot 1092 includes a chamfered surface 1096. This ement es a tapered lead-in to allow easier assembly to the cushion 1072.

, Also, the section of the nasal prong 1070 (where the nasal column 1087 meets the base portion 1086) provides axial spring and compression (e.g., similar to a shock absorber) to compensate for slight variation in angle and ce between the cushion and the patient's nares. Specifically, this section provides a trampoline-type arrangement that allows the nasal column 1087 to move axially into the base portion 1086. This forms a kind ofball joint which odates both short and large axial distances to the patient's nares.

The upper section profile of the head portion 1084 may be varied to better odate nares of different patients. For example, the upper section profile may haVe a convex shape (as shown in Fig.‘63), a straight shape (as shown in Fig. 64), or a concave shape (as shown in Fig. 65). In an alternative embodiment, the head portion 1084 may be formed of be deformed to conform so that the head portion 1084 may a deformable material, e.g., foam, to a patient's nare. be varied to control lateral Also the wall section of the head portion 1084 may head portion 1084 having one wall stiffness/rigidity. For example, Fig. 66 illustrates a than an opposing wall section. section (the left side) that is thicker §4.2.5 Nasal Prong Length known in the art, e.g., nasal prongs ] The nasal prongs are longer than those filed on February 20, 2004, the entirety disclosed in U.S. Patent Application No. ,929, is desired for a number ofreasons. incorporated herein by nce. This increased length ” to the back of the to “reac ] First, the length of the nasal prong is desired cushion which spaces the base ofthe patient's nose. This is due to the presence of the mouth “behind” the face. prongs from the t's Specifically, the base of the prongs is positioned lip. Thus, the prongs must be membrane and undercushion that seal on the patient‘s upper to the patient's nose. In contrast, the nasal prong of longer to extend from the mouth cushion the patient's face so its length is shorter. the '929. application sits very close to desired to ensure that g on all Second, the length of the nasal prong is mouth match varying naso-labi'al angles. The facial geometries can be satisfied, i.e., to Due to the height ofthe cushion precludes rotation of the device to match naso-labial angles. in distance at the bottom of the mouth cushion, mask, rotation would result in a large change which would present a sealing challenge. In the '929 application, the prongs are provided to match g naso-labial angles. a “barrel” that can be rotated section allows greater Third, the additional length of the nasal prong This in turns provides additional compression than that achievable in the '929 application. balance ofnose and mouth g. sealing at the nose and s in achieving an appropriate of “suspension”. In this base ofthe column will act as a form In addition, compression at the section (i.e., m0ve downward or side cushion can move away from the prong way, the mouth section moves, the seal at the nose. As the mouth cushion to side) without disrupting the and hence seal at the while still maintaining sufficient load prong section can uncompress nose. This is not provided in the '929 application as the absence of a mouth n means the device is much more difficult to disrupt on the face.

In an embodiment, the column or stalk 1087 has a length in the range of 9-20 mm. In a preferred embodiment, the stalk 1087 has a length of 12 mm.

In an alternative embodiment, nasal prongs 1070 in their free state may be inset into the mouth cushion 1072 as shown in Fig. 66B. The prongs 1070 shown in Fig. 66B may have a length ofup to 70 mm. A r embodiment is disclosed in PCT Application No. , filed December 24, 2004, which is incorporated herein by reference in its entirety. § 4.2.6 Articulation The prong arrangement ofthe present invention provides independent movement ofboth ends ofthe "stalk" or nasal column ofthe prong. Hence the head portion or pillow section can articulate independent ofthe base portion'or "trampoline" n. This form ofindependent suspension allows both axial and rotational movement ofthe top of the prong. It also allows for the head portion and base n to remain parallel despite movement or bending ofthe stalk.

To match the varying naso-labial angles, the prongs are designed to articulate at both ends. The ry used allows the joints at each end to act much like “ball in socket” joints and conform to ent facial geometries. The additional length of the prongs allow this articulation (rotation of the prong around its base) without the underside of the prong interfering with the mouth cushion. §4.2. 7 Dual- Wall Nasal Prong Figs. 67-70 illustrate a nasal prong 1070 having a dual or double-wall head portion 1084. As rated, the head portion 1084 includes an inner wall 1002 and an outer wall 1004 that surrounds the inner wall 1002. In an ment, the outer wall 1004 is substantially thinner than the inner wall 1002, and no more than 0.65 mm thick. In the illustrated embodiment, the inner and outer walls 1002, 1004 are molded in its in use position. In use, the thin outer wall 1004 inflates and/0r allows conformance to the inner periphery of the patient's nare to enhance the seal of the head portion 1084 against the patient's nare. The dual wall nasal prong may reduce the time of mask set-up as it provides more y to seal, e. g., thin outer wall conforms to the patient's nasal contours. An early generation dual-wall nasal prong is disclosed in PCT Application No. , filed December 24, 2004, which is incorporated herein by reference in its entirety. Also, a all nasal n is disclosed in US. Patent No. 6,112,746, which is incorporated herein by nce in its ty.

The thin outer wall 1004 (also referred to as an outer membrane) may have a thickness in the range of 0.1 mm to 0.65 mm. In a preferred embodiment, the thin outer wall 1004 has a thickness of 0.35 mm. In contrast, the inner wall 1002 (also referred to as an inner ne) has a thickness of about 0.75 mm, which is substantially similar to the thickness ofthe base 1086 and the column or stalk 1087. In other arrangements, it would also be possible to eliminate the inner wall, just leaving the thinner outer wall membrane for contact with the patient.

The outer wall 1004 is relatively thin to provide compliance and/or conformance with the patient's nose to enhance the seal of nasal prong 1070. That is, the thinner outer wall 1004 allows superior sealing due to its ability to conform to the nasal contours. The thicker inner wall 1002 supports the thinner outer wall 1004 as the prong 1070 is inserted and/or engaged with the patient's nose, e.g., so the outer wall 1004 does not collapse. When the prong 1070 is rized, the outer wall 1004 conforms to the patient's outer wall nose and the inner wall 1002 "floats" under the patient's nose, e.g., spaced from the 1004. An adequate gap, e.g., 0.75 mm, is provided between the inner wall 1002 and the outer wall 1004 to allow movement of the inner wall 1002 without disturbing the seal of the outer wall 1004. The gap between the inner and outer walls 1002, 1004 may vary around the perimeter of the head portion 1084 in use, e.g., depending on set-up and/or movement during use.

] The relatively thin wall thickness, e.g., 0.35 mm, is preferably provided to an outer wall of a all prong configuration. However, the thin wall thickness may be ed to a nasal prong-having a single wall configuration. As noted above, the thin membrane allows superior sealing due to its ability to conform to the patient's nasal contours.

For example, a nasal prong having a single wall head portion may have a wall thickness in the range of 0.1 mm to 0.65 mm, e.g., ably 0.35 mm. In an embodiment, as shown in Fig. 62B, the thin head n 1084 may include a r top section or bead 1089 to prevent excessive flash and/or tearing as the nasal prong 1070 is removed fiom its mold.

However, the head portion may include other structure to prevent excessive flash and/or tearing. For example, one or more internal ribs may be added to the head portion 1084, e.g., in lieu of or in addition to beading 1089. As shown in Figs. 57 and 58, ribs 1090 may be provided to a thin, single wall head n 1084. In another embodiment, a single wall head portion may be provided with a tapered or varying cross-section along its , e.g., wall thickness tapers from vely thin to thick.

In an alternative embodiment, instead of a one-piece arrangement, a thin outer membrane may be provided as a separate ent that is retro-fit (attached, coupled, glued, etc.) to a single wall nasal prong. For example, a thin outer membrane may be provided to an exterior surface of the head portion and secured in position, e.g., by an elastic ring. The other ne 1004 need not be made of the same material (e.g., Silicone) as the inner wall 1002, so long as it is patient friendly and compliant.

In a red embodiment, the head portion 1084 of the dual wall nasal prong includes a substantially ht conical section 51 that ramps down to a relatively large elliptical or curved section s2, e.g., see Fig. 70. The curved section is configured to match the t's nares g at the bottom, the conical n improves insertion into the patient's this profile nose, and dual-wall configuration achieves a quicker more effective seal. That is, arrangement has the ability to locate or insert the head portion into the nose easier, which optimizes set-up time. In use, patients may establish a seal about halfway up the head portion. This profile arrangement may also be provided in a single wall nasal prong, e.g., see Fig. 62.

In the illustrated embodiment, the base portion 1086, stalk 1087, head portion 1084, and opening 1069 each include oval or elliptical shapes when viewed in plan view, e.g., see Fig. 68. However, other shapes are possible depending on application, e.g., shape of the patient's nose. For example, the base portion, stalk, head portion, and/or opening may have a circular shape. Also, the nasal prong may be configured such that portions ofthe prong transition from elliptical to circular shapes, e.g., base portion ofthe head portion may be generally ar and the head portion and outlet openings may be elliptical and the prong transitions therebetween.

In the illustrated embodiments, the dual wall nasal prong has an outer wall 1004 that is longer than the inner wall 1002, e.g., see Figs. 67 and 70. This arrangement may help with sealing and may assist in removal of the dual wall nasal prong from the molding tool. In ative embodiments, the outer wall 1004 may be of an equivalent length or shorter than the inner wall 1002.

Also, a surface finish may be added to one or more surfaces of the dual-wall nasal prong. The surface finish may help in removing the nasal prong fiom its molding tool. ln addition, the e finish may help with sealing.

Specifically, a surface finish may be provided on the inner surface of the outer wall 1004 to assist removal of the nasal prong from the tool, e.g., a g core. A surface finish provided on the outer surface of the outer wall 1004 may also help removal ofthe nasal prong fiom the tool and may assist sealing with the patient's nare. Similarly, a surface finish removal of may be provided on the inner and/or outer surface of the inner wall 1002 to help the nasal prong from the tool. As noted above, beading around the top periphery of the outer wall 1004 may be applied to prevent excessive flash and/or tearing on removal from the tool.

In addition, the molding tool itself may include surface finish, e.g., frosted surface finish, to facilitate removal from the nasal prong. For example, a surface finish may be added to molding tool surfaces that engage the inner surface of the outer wall 1004 and/or the outer surface of the inner wall 1002. However, the entire exterior surface or portions of the exterior surface ofthe tool may have a surface finish.

] The base portion 1086 of the dual—wall nasal prong is similar to that of the nasal prong having a single-wall slot 1092, rounded upper flange 1094, chamfered , e.g., lower flange 1096, and axial spring section. However, the base of the all nasal prong and 58. may have other suitable constructions, e. g., such as the base shown in Figs. 55, 56, ] As bed above, the nasal prong es upper and lower trampoline-like bases that provide articulation, a self-adjusting length, and a force for sealing. The trampoline-like base includes two curved sections at the top and bottom thereof, and a straight section at the middle thereof. This structure provides the nasal prong with a form of suspension.

Specifically, the trampoline base detail is provided at both ends of the stalk.

The trampoline base detail acts as a universal mechanism to articulate and align the head portion of the pillow to the patient's alar and nasolabial angles, self-adjust the stalk length to suit the patient's bial height, and/or provide a table sealing force to the nares.

That is, the trampoline base detail allows on of the stalk relative to both the head portion ofthe pillow and the base portion, and allows reduction in height of the head n of the pillow relative to the base n.

Figs. 70B-1 to 70B-10 illustrate a paired-prong arrangement wherein nasal prongs 1070 are provided as a pair on a single insert. As illustrated, each nasal prong 1070 includes dual-wall head portion such as that described above in Figs. 67-70. The prongs 1070 are joined at respective base portions by a bridging or connecting strap 1088.

Figs. 70B-l to 70B-10 illustrate exemplary dimensions for a paired prong arrangement, e.g., medium size. In the illustrated embodiment, D[ is 10.5 mm, D2 is 22.5 mm, D3 is 33.6 mm, D4 is 38.9 mm, D5 is 41 mm, D6 is 8 mm, D7 is 10.3 mm, D8 is 25.1 mm, D9 is 4.6 mm, D10 is 7 mm, D“ is 20.1 mm, D12 is 14.2 mm, D3 is 9.4 mm, D14 is 66.45 nun, and D15 is 24.5 mm. Although specific dimensions are provided, it is to be understood that these dimensions are merely exemplary and other dimensions are possible depending on application. For e, the exemplary diniensions may vary by 10—20% or more or less depending on application.

] In an embodiment, all internal surfaces of each prong 1070 are relatively flash fi‘ee. In addition, the outer wall 1004 is relatively free from partlines and flash. Also, the free end of the outer wall 1004 is smooth and has a rounded edge, e. g., no sharp edges, and‘ vely free from flash and tears. Further, the entire paired prong ement may be mirror polished, although some selected surfaces may have a non-polished surface finish, e.g., inner surface of outer wall.

In an embodiment, one of the inner and 'outer walls may be molded in an open position and then inverted to form the dual wall construction. This arrangement simplifies the g process.

For example, the inner wall 2502 may be molded in an open position (as shown in Figs. 71—74), and then inverted internally to form the dual wall construction (as shown in Figs. 75-77). The wall section may be varied to_ control stiffiiess/rigidity. For example, one wall (e.g., inner wall 2502) may be thicker than the other, or both walls may be vely thin. Also, as shown in Fig. 72, an integrated hinge 2506 may be provided between the walls 2502, 2504 to control the fold-over location.

Figs. 78-83 illustrate an alternative arrangement wherein the outer wall 2604 may be molded in an open position (as shown in Figs. 78-80), and then ed externally With respect to the inner wall 2602 to form the dual wall construction (as shown in Fig. 81- 83). The wall section may be varied to control stiffiiess/rigidity (e.g., inner wall 2602 (e.g., 0.7 mm) thicker than outer wall 2604). In an embodiment, the outer wall 2604 acts like a "tacky" filler between the head portion 1084 and the patient's nare.

Figs. 84-89 illustrate a nasal prong 1070 having a triple-wall construction. It should be tood that the nasal prong 1070 may have other suitable multi—wall constructions, e.g., head portion 1084 with two or more walls. As illustrated, first and second outer walls 2704, 2705 may be molded in an open position (as shown in Figs. 84-86), and then inverted externally with respect to inner wall 2702 to form the triple wall construction (as shown in Fig. 87-89).' The wall section may be varied to control stiffness/rigidity.

Furthermore, the fold lines may be positioned differently to e a ent length fold- over portion.

The dual wall arrangement facilitates sealing of the nasal prong in the nares by combining a structure-defining thicker wall with a seal-forming thinner wall. A very thin wall, while suitable for forming a seal, may lack sufficient stiffness by itself to t the necessary structure in use. As discussed above, adding ribs can stiffen a wall otherWise too thin to support itself in use.

The dual-wall nasal prong may be orated into other mask systems. For example, the dual-wall nasal prong may be orated into a nozzle assembly such as that sed in US. Patent Application No. 10/781,929, filed February 20, 2004, the entirety incorporated herein by reference.

] Fig. 89B illustrates an embodiment of such an arrangement. As illustrated, the nozzle assembly 2810 includes a base portion 2811 and a pair of dual-wall nasal prongs 2870 provided thereto. The base portion 281] is d to be attached to a frame as described in l the '929 application. As described above, each dual-wall nasal prong 2870 includes a head portion 2884 having an inner wall 2802 and an outer wall 2804.

In an embodiment, the outer wall 2804 may have a surface finish applied to improve manufacturability. §4.3 Mouth Cushion As best shown in Figs. 94, 96, 106 and 120B-120F, the mouth cushion 1072 es a non-face-contacting portion 1038 and a face-contacting n 1040. The non- face-contacting portion 1038 is structured to be removably and ably attached to the frame 1074. In the illustrated embodiment, the non-face-contacting portion 1038 includes arrow-head, type design having a tapered end portion 1042 with a sealing lip 1044. The tapered end portion 1042 is’ adapted to, be easily inserted and retained, via a retaining bead 1049, within a channel 1075 provided on the frame 1074 (see Figs. 121, 167, and 120B- 120F). The sealing lip 1044 provides a seal around the perimeter ofthe cushion 1072 and also retains the cushion 1072 onto the frame 1074. In an embodiment, alignment es, e.g., diamonds or triangles or other s, may be provided on the n 1072 and frame 1074 to aid correct assembly. Cushion ment to the flame may be similar to that disclosedin U.S Application No 10/390,682, which1S incorporated herein by reference 1n its entirety. However, other cushion attachment methods are possible.

The face-contacting portion 1040 of the n 1072 includes a side wall 1046, an undercushion 1047 extending away from the side wall 1046, and a membrane 1048 provided to substantially surround the ushion 1047 and provide a sealing structure for the face-contacting portion 1040. The inner edge of the membrane 1048 defines an aperture that receives the patient's month. Also, the side wall 1046 includes spaced-apart prong support structures 1045 that provide annular recesses 1073 adapted to support respective prongs 1070 (e.g., see Figs. 94, 96, 112, and 113). As illustrated, the prong support structures 1045 provide an angled al that project the prongs at the, correct angle to the patient's nares. §4. 3.1 Shape of Lower Chin Region in Front and Side Views Figs. 90-98 illustrate the shape of the cushion 1072 with respect to ResMed's full face mask cushion 1200 (shown in isolation in Figs. 91 and 97) and ResMed's mouth in the comparison in Figs. 92 and 98). As rated mask cushion 1300 (shown in isolation lower chin region 1072 has a different shape in the views of Figs. 93 and 96, the cushion side. when viewed from the front and the to width ratio different) Specifically, the cushion 1072 is "squarer" (height dots D) ofthe patient's mouth (area indicated by the lower chin region and lower s full face mask in Fig. 93, as compared to ResMed's when viewed from the front as shown ofthe ofthe cushion 1072 covers more cushion 1200 which is more curved . This shape lower chin region as indicated by the hatched region in Fig. 93. Also, this shape of the chin region based on variations in facial curvature in the cushion 1072 better accommodates seals around deep lines radiating anthropometric data. Further, this shape of the cushion 1072 mouth This provides a better seal when from the mouth often found on older patients. indicated in shape in the lower chin region (area movements occur during sleep. This change viewed from the side as shown in Fig. by dot D) is also illustrated when about the axis of the mouth (see ] In addition, the cushion 1072 is assymetric about the axis of the mask cushion 1300 is rical Fig. 90), whereas ResMed's mouth outer radius in the chin region mouth (see Fig. 92). Also, the n 1072 has a smaller ruin Fig. 90). radius in the upper lip region (shown as (shown as r1 in Fig. 90) than the outer and Bottom Views - Chin and Upper Lip Regions in Top §4.3.2 Shape of Membrane at Lower ResMed's ofthe cushion 1072 with respect to Figs. 99—103 illustrate the shape mouth mask in isolation in Fig. 102) and ResMed‘s full face mask n 1200 (shown As best shown in the comparison views cushion 1300 (shown in isolation in Fig. 103). in curvature at the chin 1048 of the cushion 1072 is r Figs. 99 and 100, the membrane 1200 at the chin to ResMed's full face mask cushion and upper lip regions when compared chin (when viewed from the bottom ofthe cushion membrane 1048 at the area. The curvature the curvature of the cushion is substantially similar or the same as as shown in Fig. 100) viewed fi'om the top as shown in Fig. 99). membrane 1048 at the upper lip region (when ofthe cushion membrane 1048 includes _a As shown in Fig. 101, this ure S joined to the side C and txvo convex curved side regions concave parabolic center region walls of the cushion 1072. This arrangement is in contrast to the curvature of ResMed's mouth mask cushion 1300 which is definedby a shallower radius (see Figs. 99 and 100). §4. 3.3 Shape of Undercushion in Top and Bottom Wews Figs. 8 illustrate the shape of the undercushion 1047 with respect to ResMed's full face mask cushion 1200 (shown in isolation Fig. 108). ResMed's mouth mask cushion 1300 does not include an undercushion. As illustrated in the comparison views of Figs. 104 and 106, the undercushion 1047 is the same or similar in curvature at the chin and upper lip regions to ResMed‘s full face mask undercushion 1200.

The curvature of the undercushion 1047 at the chin region (as viewed from the bottom in Fig. 106) is the same or similar to the curvature of the undercushion 1047 at the upper lip region (as viewed item the top in Fig. 104); This curvature is illustrated in Fig. 107 and includes a ntially flat center portion C and angled side portions S. The center and side portions are joined together by /radii portions R1. The side portions S merge into a second smaller radius R2 where the cross-sectional out has been made. §4.'3.4 Width of Undercushion and Membrane at Upper Lip and Chin Regions As shown in Figs. 109-110, the width of the undercushion 1047 and the membrane 1048 at the upper lip region is less than the width of the undercushion 1047 and the membrane 1048 at the chin region. The width ofthe undercushion 1047 in the upper lip region is smaller such that it fits in the relatively narrow region between the nares and the upper lip (see Fig. 111) and anthropometric variations in patient population.

In an embodiment, the Width ofthe undercushion 1047 and membrane 1048 at the upper lip is between 20% to 80% of the width ofthe undercushion 1047 and membrane ' 1048 at the chin region. For example, as shown in Fig. lllB, dimension A may be about 4 mm, dimension B may be about 6 mm, ion C may be about 8.8 mm, and ion D may be about 11 mm. These ions may be similar for small and large size ns.

Although specific dimensions are provided, it is to be tood that these dimensions are merely exemplary and other dimensions are possible depending on application. For example, the exemplary ions may vary by 10—20% or more or less depending on application. §4.3.5 Cushion Wall Cross-Section As shown in Figs. 112-119, the section of the cushion 1072 varies along the perimeter of the cushion 1072. In the illustrated embodiment, there are three distinct cross-sections that define the shape of the membrane 1048 and undercushion 1047 along their perimeters. As illustrated, cross-sections A, B, and C are provided in upper lip, side, and chin regions of the cushion 1072. It is noted that the cross-section B is symmetrical on both sides ofthe cushion 1072. However, alternative embodiments may e more than three cross- sections. l00295] Elements that define each cross-section A, B, and C (for both the undercushion 1047 and the membrane 1048) include angles [3 and a between the cushion side wall 1046 and the tip of the undercushion 1047 and the tip ofthe membrane 1048, respectively (see Fig. 117), widths WI and W2 fi'om the cushion side wall 1046 to the tip of the undercushion 1047 and ne 1048, respectively (see Fig. 118), heights H1 and 'H2 fiom the top of the cushion side wall 1046 to the tip of the undercushion 1047 and membrane 1048, respectively (see Fig. 119), and radii r1 and r2 between thecushion Side wall 1046 and the tip of the undercushion 1047 and membrane 1048, respectively (see Fig. 118). The undercushion 1047 and membrane 1048 ofthe illustrated embodimentsalso e straight portions s1 and s2, respectively, at some cross-sections. However, other elements may be included to define each cross-section.

In an embodiment, the shape or profile of the cushion 1072 may be defined by three points selected at common points of each of the three cross-sections. At each of the three points, x, y, and z coordinates are defined, Where x dimensions are measured from an anthropometrical datum, y dimensions are measured'from a al symmetry line, and 2 dimensions are measured from the cushion height. The shape of the n 1072 ly varies between the three points along its perimeter.‘ §4.‘4 Frame As best shown in Figs. 4 and 167, the flame 1074 includes a main body 1076 having a side flame portion 1078 on each lateral side thereof. The main body 1076 includes an aperture 1080 and a flanged collar member 1082 that surrounds the aperture 1080.

The elbow assembly 1014 is coupled to the flanged collar member 1082 in a manner as described below. The flame 1074 also includes the channel 1075 for retaining the cushion 1072 as bed above.

In the illustrated embodiment, a vent assembly 1079 is provided in each side flame portion 1078, ofthe frame 1074 for CO2 washout. The vent assembly may be Configured such as those disclosed in US. Provisional Patent Application No. 60/_, ed "Nasal Assembly" and filed April 28, 2006 (Docket No. 4398-527), which is incorporated herein by reference in its entirety. However, one or more vent openings may be provided in the swivel elbow 1014 for CO2 washout.

As shown in Figs. 124B—124I, the vent assembly 1079 is provided in each side flame portion 1078 ofthe flame 1074, adjacent the upper anchors 1041 bed below.

Each vent assembly 1079 includes an array or pattern ofrelatively small holes 1011 arranged in a plurality of columns, e.g., 3-10 columns, and in the example rated, 5 columns. The columns are vertically staggered with respect to one another; Also, the first hole in each column cooperate to form an axis A that is angled at an angle a (when viewed flom the flont as shown in Fig. 124E) of about 15-3 5°, e.g;, 25°, with respect to vertical axis V. As best . shown in'the side View of Fig. 124G, each hole is provided along a plane P (approximate ' plane shown in Fig. 124G due to flame angle in side View) that forms an angle [3 of about 20- 40°, e.g., 30°, with respect to vertical axis V. As shown in the bottom View of Fig. 124H, each hole has a longitudinal axis L that is angled at an angle of about -10° to 45°, e.g., 0°, with respect to transverse axis T. Each column includes 2-6 holes, e.g., 4 holes. In the illustrated embodiment, each hole 1011 has a generally part conic shape, including opposed Walls that converge flom a larger er to a smaller er, as viewed in the direction of ted gas. The smaller diameter may be about 0.7mm, the larger diameter may be about 1mm, the included angle ofthe cone may be about 10° and the height ofthe cone may be about 1.7mm. However, other vent arrangements are possible.

As illustrated, the holes 1011 are located away flom the aperture 1080 to avoid air flow erenCe. Also, the holes 1011 are d near headgear attachment points where the flame 1074 is relatively flat to the users face for the anchor structures. In addition, the holes 1011 are positioned on vely flat portions of the flame 1074 so that air may be vented perpendicularly flom the general plane of the patient’s face to avoid air jetting towards a bed partner. Thus, this vent arrangement optimizes mask operation and is synergistic in that it utilizes an area of the flame. 1074 which is relatively flat to the patient's face for two es, i.e., anchor structure and perpendicular venting. Aesthetics of the flame 1074 are also improved significantly by reducing the number of relatively flat areas that are provided on the flame 1074. §4.4. 1 Anchor Points for Headgear Assembly ] Each side frame portion 1078 includes upper and lower anchors 1041, 1043 for attaching the ar assembly 1018. As best shown in- Figs. 120-124‘ and 167, each upper anchor 1041 is in the form of a female connector that provides a slot opening 1062, and each lower anchor is in the form of a clip receptacle 1071. Attachment of the flame 1074 to. the headgear assembly 1018 will be described in greater detail below.

The flame 1074 provides four anchor points (as shown in Figs. 120 and 167) for securing the mask system 1010 onto the t's face. As rated, the anchor points are located at the vertical and horizontal extremities ofthe flame 1074 to provide maximum stability by acting as "outrigger" elements. §4.5 Elbow Assembly As shov'vn in Figs. 125-140, the elbow ly 1014, e.g., swivel elbow, includes an elbow 1051, an anti-asphyxia valve (AAV) 1052, and a clip member 1053 to secure the AAV 1052 to the elbow 1051.

The elbow 1051 includes a first portion 1081 connectable to the flame 1074 and a second portion 1083 connectable to an air delivery tube 1008 (see Figs. 48, 155, and 120). The first portion 1081 of the elbow 1051 is releasably connected to the flanged collar member 1082 ofthe flame 1074 in a snap-fit manner as is known flom U.S. Patent Application Publication No. 2003/0196656, which is orated herein by reference in its entirety.

The elbow 1051 also includes a slot 1091 to receive the AAV 1052, a port 1093 that is selectively closed by a flap n 1063 of the AAV 1052 (depending on the presence of pressurized gas), and two recesses or protrusions (not visible) for attaching the clip member 1053 with a snap-fit.

The AAV 1052 interlocks with the clip member 1053 to provide a sub— ly that is removably attached to the elbow 1051 with a snap-fit. Specifically, the AAV 1052, e.g., constructed of flexible silicone or other elastic material, includes an arrowhead- shaped sion 1095 that removably interlocks with a slot 1097 provided on the clip member 1053, e.g., ucted of rigid plastic. As illustrated, the inside edges of the slot 1097 are filleted to allow for easier assembly of the AAV 1052. In addition, the arrdwhead shape of the protrusion 1095 facilitates assembly. However, the inside edges ofthe slot 1097 may have a conical fillet or chamfer, for example, to facilitate assembly. Also, the protrusion 1095 ofthe AAV 1052 may have a filleted, curved, charnfered, or tapered end to facilitate assembly.

The clip member 1053 es two tabs 1099 that interlock with tive recesses/protrusions (not shown) provided to the elbow 1051. In addition, the clip member 1053 es structure to prevent incorrect assembly ofthe AAV 1052 to the elbow 1051.

Specifically, the clip member 1053 includes recessed sides 1033 and a central vertical rib 1035 integrally molded with the clip member 1053. When the clip member 1053 is assembled to the elbow 1051, the recessed sides 1033 and central al rib 1035 are located against the elbow outer surface 103 7, e.g., flush against the elbow outer surface, to prevent the AAV 1052 fi'om being assembled between the clip member 1053 and the elbow 1051. For example, if the clip member 1053 is assembled to the elbow 1051 with the AAV 1052 in an incorrect orientation (as shown in Fig. 140 and in dashed lines in Figs. 137 and 138), the ’flap portion 1063 of the AAV 1052 will be positioned between the central vertical rib 1035 and the elbow outer surface 1037, which prevents the clip member 1053 fiom interlocking with the elbow 1051. It would then be evident to a user that the AAV 1052 had not been correctly installed.

In addition, as shown in Fig. 140, the flap portion 1063 of the AAV 1052 is longer than the clip member 1053 is wide such that if the AAV 1052 is incorrectly assembled, the flap portion 1063 will extend e of the clip member 1053 and thereby provide a visual and tactile cue to the patient that the AAV 1052 has been ectly assembly to the elbow 1 05 1 . surrounding the port 1093 of In an embodiment, al, e. g., wall thickness, material. However, sufficient material is the elbow 1051 may be cutuaway to reduce 1063 of the AAV 1052 in use. maintained to allow surface area for engaging the flap portion 1014 are disclosed in PCT ative embodiments of the elbow assembly incorporated herein by nce in its Application No. , which is entirety. §4.6 Headgear Assembly 1018 includes an As best shown in Figs. 141-154, the headgear assembly that is attached to the upper 1020 and a lower headgear section 1030 upper headgear section 1050 are provided between the upper headgear section 1020. Upper izing elements and lower stabilizing ts 1060 are provided ar section 1020 and the frame 1074, and the frame 1074. between the lower headgear section 1030 ' a pair r The headgear assembly preferably includes elastic straps, e.g., includes the rigid or semi-rigid stabilizing and a pair of lower elastic straps, and preferably from the c straps, may comprise a ts. The stabilizing elements may be separate of the mask frame In any event, the sub-assembly with the elastic straps, or may form part having sufficient magnitude and direction headgear assembly defines a sealing force vector nasal region. effect a seal t both the mouth and lower nasal mask alone, nasal prongs Unlike prior art mask systems including a surfaces 1010 provides a sealing force against two alone, or a full-face mask, the mask system the mouth and the nares. The which are almost at right angles to one another, namely and arranged to achieve sufficient headgear straps and stabilizing elements are configured The headgear ofprior art masks typically only sealing force ents in both directions. . substantially in one direction. provide a sealing force in one direction or several factors including the The magnitude of the sealing force relates to are tightened. The direction of elasticity ofthe headgear straps and how tightly they is attached to the frame and where it engages sealing force relates to where the headgear strap with the patient's head. ts that in turn conne The upper straps connect to upper stabilizing and mouth. lies generally between the nose the mask frame in a region which in use that and connect with a rear headgear n the upper straps pass over the patient's temples elements allow a generally engages the occiput of a patient'3 head. The upper stabilizing of the the nares without obscuring the vision patient. sufficient force component to seal with of the patient's skull Furthermore, by engagement with rigid or bony s and tendon), the seal provided by the headgear assembly and avoiding non-rigid (e.g., muscle movement of the patient's head. 1018 is less likely to be ted by _ §4.6. 1 Headgear Sections 1020 includes upper straps As shown in Figs. 141, the upper headgear section end of each upper strap 1022 1022, bridge straps, 1024, and front crown straps 1026. The free elements for use in securing the upper stabilizing includes a tab ro® material 1028 tab 1028 may be 1020 (see Fig. 143). The Velcro® 1050 to the upper headgear section for example. In the illustrated d to the upper strap 1022 by ultrasonic welding, formed, e.g.,_ punched, from the same piece of embodiment, the bridge straps 1024 are the bridge straps front crown straps 1026 such that material as the upper straps 1022 and the the bridge 1022 as shown in Fig. 141. Then, 1024 are separated from tive upper straps three-dimensional shape. straps 1022 to form a straps 1024 are attached to respective upper in Fig. 4d.

This arrangement is similar to that shown section 1030 includes lower straps As shown in Fig. 142, the lower headgear 1032 includes a tab of The free end of each lower strap 1032 and rear crown straps 1034. elements 1060 to the lower Velcro® material 1036 for use in securing the lower stabilizing to the lower The Velcro® tab 1036 may be secured headgear section 1030 (see Fig. 143). for example. strap 1032 by ultrasonic welding, mensional upper and lower headgear ] Figs. 141 and 142 illustrate the section embodiments of the upper 9 illustrate dimensions of 1020, 103 0, and Figs. and 10 1030. wer headgear sections 1020, Specifically, Figs. 6 illustrate exemplary dimensions for large, medium, and small upper headgear sections 1020, respectively, lower for large, medium, and small headgear Figs. 147-l49 illustrate exemplary dimensions sections 1030, respectively. In an embodiment, as shown in Figs. 144-146, LDI is 153 mm, MDl is 128 mm, MD2 is 147°, MD3 is 119 mm, MD,1 is 18 mm, MD, is 33°, MD6 is 76.9 mm, MD7 is 118.9 mm, MD, is 84 mm, MD9 is 18 mm, MDlo is 25 mm, and SDl is 107 mm. In an embodiment, as shown in Figs. 147-148, LD1 is 245 mm, MDl is 220 mm, MD2 is 147°, MD is 18 mm, MD4 is 25 mm, MD5 is 107.9 mm, MD6 is 67 mm, MD7 is 33°, MD, is 25°, and SDl is 220 mm. Although specific dimensions of the upper and lower headgear sections 1020, 1030 are provided, it is to be understood that these dimensions are merely exemplary and other ions are possible depending on application. For example, the exemplary diinensions may vary by 10-20%.

The mensional first and second headgear sections 1020, 1030 are attached to one another, e.g., machine sewn butt joints, to form a three-dimensional anatomically shaped headgear assembly 1018. Figs. 141 and 142illustrate the attachment points in dotted lines, e.g., A joins to A, B joins to B, C joins to C, and D joins to D. As illustrated, the fiee end of each rear crown strap 1034 includes a widened portion 1019 to facilitate ment.

Figs. 4 illustrate the three-dimensional headgear assembly 1018 positioned on the patient's head. As illustrated, the crown straps 1026, 1034 cooperate to form a round-shaped crown strap that cups the parietal bone and tal bone of the patient's head. Fig. 141 illustrates a cross-over point Y where the upper headgear n 1020 crosses over the crown of the patient's head, and Fig. 142 illustrates a cross—over point Z where the lower headgear section 1030 crosses over the lower occiput of the patient's head (i.e., bony structure at the back ofthe patient‘s head). §4. 6.2 Stabilizing Elements ] As best shown in Figs. 48 and 155; the upper and lower stabilizing elements 1050, 1060 provide a stable connection system between the upper and lower straps 1022, 1032 and the sealing assembly 1012 in order to protect and ensure the seal with both the patient’s mouth and the patient’s nasal es. That is, the upper and lower stabilizing elements 1050, 1060 in the position of the upper and lower straps 1022, 1032 relative to .each other, and secure the mask system 1010 at the correct orientation on the patient's face.

The upper and lower izing elements 1050, 1060 also act as "outriggers" to the flame 1074 to provide a larger footprint on the patient's face. This increases the stability of the mask system. .1 Upper Stabilizing ts . As shown in Figs. 156-158 (illustrating a left side upper stabilizing element, the right side upper stabilizing element being symmetrical in design to the left side), each upper stabilizing element 1050 is constructed from a rigid or semi-rigid al, e.g., plastic al or nylon, and includes a three-diniensional shape so as to contour or conform to the shape of a patient's face. As shown by the dotted lines in Fig. 157, each upper stabilizing t 1050 includes at least one bending plane, e.g., two distinct bending planes B1 and BZ, that allows flexing to conform to the shape of a patient’s face.

One end of each upper stabilizing element 1050 includes a ar 1054 that enables the end portion of a respective upper headgear strap 1022 to be wrapped around, in a known manner. Each upper strap 1022 es the Velcro® band 1028 that engages the remainder of the strap to ably secure the crossbar 1054 in place. The opposite end of each upper stabilizing element 1050 includes a post element 1066. Each post element 1066 engages Within a respective slot opening 1062 provided to the frame 1074, e.g., with a snap- fit. This attachment is similar to that shown in Figs. 11-15 described above.

Figs. 158b-1 to 158b-6 illustrate an alternative embodiment of the upper stabilizing element 2550 that includes structure to prevent misassembly with the flame 1074.

As illustrated, the post element 2566 of the upper stabilizing element 2550 is ted by opposing end portions 2567, 2569. One of the end portions 2567 is relatively larger than the other of the end portions 2569. The enlarged end portion 2567 provides a key to facilitate assembly of the upper stabilizing element 2550 to the frame 1074 in the correct orientation.

As shown in Fig. 158b-7, each upper anchor 1041 of the flame 1074 is ured such that sufficient space is provided on only one side of the upper anchor 1041 to accommodate the enlarged end portion 2567. Thus, if the upper stabilizing element 2550 is attempted to be engaged in the wrong orientation With the upper anchor 1041, the enlarged with the respective element 2566 from ocking end portion 2567 will prevent the post 1041. slot opening 1062 of the upper anchor another embodiment of an upper stabilizing Figs. 158c-1 to 158c—4 illustrate 2641 structured to accommodate element 2650 and a frame 2674 having an upper anchor side upper such upper izing element 2650. Figs. 1580—1 and 158c-2 show a right element 2650. shows a lefi side upper stabilizing izing element 2650, and Fig. 1580-3 includes an each upper stabilizing element 2650 Similar to the embodiment described above, 2641 of enlarged end portion 2667 to t misassembly with the respective upper anchor element 2650 includes a keyway or the frame 2674. In addition, each upper stabilizing upper anchor to receive a key 2673 provided on a respective groove 2671 that is adapted the same side of the side stabilizing element 2650 is on 2641. The keyway 2671 ofthe right and the keyway 2671 ofthe left side stabilizing enlarged end portion 2667 (see Fig. 158c-2), 158c-3). of the enlarged end n 2667 (see Fig. element 2650 is on the opposite side 2673 is offrame 2674. As illustrated, the key Fig. 1580-4 shows the right side chor 2641. The left upper anchor (not shown) ed on an outer side of the right upper an the right thereof. This arrangement ensures that will have the key d on the inner side and the left side attach to the right side anchor 2641, side izing element 2650 can only the left side anchor. Specifically, the key 2673 on stabilizing element 2650 can only attach to element the keyway 2671 of the right side stabilizing the right side anchor 2641 only allows element 2650 can 2667 ofthe right side stabilizing 2650 to pass, and the ed end portion anchor 2641. Similarly, the key on the left side anchor only fit on the outer side of the right and the left side stabilizing element 2650 to pass, only allows the keyway 2671 of the the outer stabilizing element 2650 can only fit on enlarged end portion 2667 of the lefi side 2671 end portion 2667 and key 2673/keyway side of the left anchor. Thus, the enlarged orientation ofthe upper stabilizing elements 2650 can take place. ensure that only the correct §4.6.2.2 Lower Stabilizing Elements constructed lower stabilizing element 1060 is As shown in Figs. 159-166, each and allows flexing to conform to a from a rigid or semi-rigid material, e.g., plastic material, patient’s face. Specifically, each lower stabilizing element 1060 includes a locking Clip 1064 and a tail section 1065.

The tail section 1065 includes a crossbar 1067 that enables the end n of respective lower strap 1032 to be d around, in a known manner. Each lower strap 1032 es the Velcro® band 1036 that engages the remainder of the strap to adjustably secure the crossbar 1067‘in place. As 'best shown in Figs. 161 and 165, the tail section 1065 is angled with respect to the locking clip 1064 towards the patient's face so as to conform to the patient's face, In addition, the tail section 1065 is relatively thin to allow flexing under the influence gear tension so as to contour to the shape of a patient's face.

In some embodiments, the tail section 1065 may be markedly shorter or deleted altogether. In this way, the locking clip acts as bed in US. Patent Application No. 10/390,681 filed March 19, 2003, the contents being hereby incorporated by reference in its entirety. §4. 6.2.3 Locking Clip Each locking clip 1064 es two spring aims 1056 and a central tab 1058 between the two spring arms 1056. Each clip 1064 is interlocked with a respective clip receptacle 1071 provided to the flame 1074 with a snap-fit. Clip attachment is similar to that disclosed in US. Patent Application No. 10/390,681, filed March 19, 2003, US. Patent Application No. 10/655,621, filed September 5, 2003, and US. Patent No. 6,374,826, the ts of each being hereby incorporated by reference in its entirety.

] As best shown in dashed lines in Fig. 166, each spring arm 1056 and the adjacent tail section 1065 are contoured to provide an ergonomic grip and to provide a tactile cue to help differentiate the lower stabilizing t 1060 fiom the frame 1074 during disassembly. Also, each spring arm 1056 has raised grips to tate finger grip.

The central tab 1058 has a rounded front face surface 1059 (when viewed fi'om the top and bottom as shown in Figs. 163 and 166) to improve ease of assembly into the clip receptacle 1071. Also, as shown in Figs. 163 and 166, the fiont of the central tab 1058 has a bull—nose shape to prevent the locking clip 1064 fi~om becoming caught/tangled with. other parts during manufacture and assembly as well as to prevent the locking clip 1064 from ng caught on the time 1074 and receptacle 1071 during fitting.

In addition, the rear side of the central tab 1058 has a central channel 1061 with a wide open mouth that is adapted to engage a tapered rib 1068 (see Figs. 121 and 167) provided in the clip receptacle 1071. This arrangement facilitates entry and assembly of the g clip 1064 into the clip receptacle 1071. Specifically, an error with alignment of the locking clip 1064 to the clip receptacle 1071 during assembly is compensated for by the wide open mouth of the channel 1061, i.e., wide open mouth allows insertion at wider range of angles, as shown in Figs. 167-170. $4.624 g al A padded backing material or soft portion may be applied on the rear surface ofthe upper and lower stabilizing elements 1050, 1060 (i.e., the surface facing the patient‘s face) to provide comfort and to t skin irritation (particularly when the patient is sleeping on r side). The backing material may be constructed from the same material as the headgear straps, e.g., Breathe-O-PreneTM manufactured by Accumed Technologies Inc.

However, other le materials could be used, e.g., foam or cotton. The backing material may be secured to the upper and lower stabilizing elements 1050, 1060 in any suitable manner, e.g., glued or stitched. §4.6.2.5 Positioning Figs. 48, 155, 171, and 172 rate the positioning of the upper and lower stabilizing elements 1050, 1060 on the patient's face in use. As illustrated, the upper stabilizing element 1050 is contoured so that it does not obscure the forward field of view or appear in the patient’s peripheral vision. Also, the upper stabilizing element 1050 is contoured so that it conforms to the shape ofthe patient's face, particularly at the upper cheek area. The relatively thin section coupled with the inherent flexibility of the plastic material and applied headgear strap tension also assist the upper izing t 1050 to conform to the shape ofthe patient's face.

The lower stabilizing element 1060 is angled (as viewed in Figs. 161 and 165) in order to contour to the shape of the patient's face, particularly at the chin region. The relatively thin cross-section of the tail section 1065 coupled with the inherent flexibility of the plastic al and applied headgear strap n also assist the lower stabilizing element 1060 to conform to the shape of the patient's face.

] As shown in Fig. 171, the headgear assembly provides a force in the Y- direction Fy to seal under the patient's nares and top ofmouth and a force in the X-direction Fx to seal around the patient‘s lower mouth. The sealing plane and sealing'force against the patient's nares is indicated at SN, and the sealing plane and sealing force against the patient's mouth is indicated at SM.

Specifically, the pair r straps 1022 defines a first force vector (FY) that provides a force in the Y—direction and the pair of lower straps 1032 defines a second force vector (FX) that provides a force in the X-direction. As illustrated, the first force vector FY extends from the upper cheek to the crown and the second force vector Fx extends fi'om the lower chin to the lower occiput (i.e., the area where bone meets muscle at the back of the patient‘s head). The curved configuration of the upper stabilizing elements 1050 offsets the first force vector FY so that the headgear assembly does obscure the patient's vision, e. g., headgear assembly is ently clear ofthe patient's eyes. For example, the dashed line L in Fig. 171 illustrates a line of force that would cause the mask to move such that the patient's vision would be obscured.

One aspect ofthis system is the angle that the upper stabilizing element 1050 makes to the mask frame and face. The angle that has been chosen is ed to affect scaling in the planes of the nasal opening and the mouth g. In this way, tightening the upper straps 1022 will simultaneously draw the nasal prongs “up” into engagement with the na'res while also drawing the mouth cushion “back” against the face (particularly above the upper lip). The angle chosen, and the resultant force vector when headgear tension is applied, allows for optimal sealing at both the nasal pillows and also at the mouth cushion. The chosen angle takes into account the various forces the mask is subject to. These include the force desired to seal against the ent pressure (as a function of sealing area), and the force desired to offset tube drag and other factors. This angle provides the l balance between nose and mouth seal.

In an alternative embodiment, instead of the headgear ly positioning and retaining both the mouth cushion and nasal pillows in a sealing position, Only one of the pair is ed by the headgear assembly, and the other of the two is ctly positioned.

That is, the headgear assembly may e a sealing force for one of the nares and mouth, and provide a platform for a force for sealing the other ofthe nares and mouth.

For example, the mouth cushion may be held in a sealing position on the face by the headgear assembly and the nasal prongs may be pushed into on under the nose by a spring mechanism extending from the mouth cushion. Thus, the headgear assembly may provide a sealing force for the patient's mouth, and the mouth cushion is used as a platform for a spring ferce to spring the prongs into sealing engagement with the patient's nares.

In another example, the nasal prongs may be held in position by headgear and the mouth cushion may be positioned by a spring mechanism extending from the nasal prongs. Thus, the headgear assembly may provide a sealing force for the patient's nares and provide a platform for a spring force to spring the mouth cushion into sealing engagement with the patient's mouth. In both examples, a force is provided in two directions to seal the patient‘s nose and mouth.

As shown in Fig. 172, the lower circumferential distance from lower chin to the lower tal region, i.e., the ce spanned by the lower headgear straps 1032, and' the upper circumferential distance fiom the upper lip to the crown, i.e., the distance spanned by the upper headgear straps 1022, remains substantially constant even when the patient's head is rotated sideways or up or down. This dimensional stability allows the mask System 1012 to be more securely retained onto the t's face, i.e., the headgear strap tension is less likely to ically change if the upper and lower circumferential distances are kept substantially constant. §4. 6.2.6 Alternative Embodiments of Upper izing Elements , Figs. 5 illustrate alternative embodiments of the upper stabilizing elements. For example, as shown in Fig. 173, the frame 1074 may include an extension 1077 that supports an upper stabilizing element 1550. As illustrated, the upper stabilizing element 1550 has a curved configuration. Intermediate and end portions of the upper stabilizing t are also supported on the frame by support elements 1555. Each end of the upper stabilizing element includes a crossbar element 1557 that enables attachment to a respective upper strap 1022.

As shown in Fig. 174, the flame 1074 may e an extension 1077 that supports an upper stabilizing element 1650. As illustrated, the upper stabilizing element 1650 is bent into a lly U-shaped configuration. Intermediate and end portions ofthe upper stabilizing t 1650 are also supported on the frame by support elements 1655. Each end ofthe upper stabilizing element 1650 includes a ar element 1657 that enables attachment to a respective upper strap 1022.

As shown in Fig. 175, the frame 1074 may include an extension 1077 that supports a pair ofupper stabilizing elements 1750. As illustrated, each upper stabilizing element 1750 has a curved configuration. Support elements 1755 extend between the pair of upper stabilizing elements 1750. Also, each end of the upper stabilizing elements 1750 includes a crossbar element 1757 that enables attachment to a tive upper strap 1022.

Figs. 176-177 rate alternative arrangements for moving the upper stabilizing elements away from the patient' eyes. For example, Fig. 176 illustrate upper stabilizing elements 1850, 1950, 2050 having different shapes. Fig. 177 illustrates an upper stabilizing element 2250 with an inverted profile to clear the patient's eyes. In another embodiment, the attachment points 1041 on the frame 1074 may be Wider, e.g., by a.distance Ad as shown in Figs. 124E, for moving the upper stabilizing ts 1050 away from the patient's eyes. In yet anOther embodiment, the upper stabilizing element may have an alternative connection to the frame 1074, such as those shown in Figs. 173-175. §5. Alternative ments Figs. 178-181 rate another embodiment of a headgear assembly 2418 including upper and lower headgear sections 2420, 2430 attached to one another. In the illustrated embodiment, the headgear assembly 2418 may include a different stitching pattern or attachment arrangement with t to the headgear assemblies described above, which may facilitate alignment and assembly. Specifically, instead ofjoints that are angled with respect to one another, the joints are vely flat, i.e., not . Figs. 178—181 illustrate the attachment points, e.g., A joins to A, B joins to B, and C joins to C.

As illustrated, the headgear assembly 2418 provides a right-angled joining ry that makes the end portions easier to align for joining. Also, the headgear assembly 2418 moves the joint area away from where the velcro fastens to the ar, which prevents potential damage to the joints, e.g., sewn joints.

Figs. 182-184 illustrate another embodiment of a lower stabilizing element 2560 including a locking clip 2564 and a tail section 2565. The locking clip 2564 is adapted to be interlocked with a respective clip receptacle provided to the mask frame and the tail section 2565 is adapted to be attached to a headgear strap.

As illustrated, the tail n 2565 is markedly shorter than the tail section 1065 oflower stabilizing element 1060 bed above. Also, the lower stabilizing element 2560 may not require a padded backing because it is shorter and does not contact the patient's face or does not contact the patient's face as much as the lower stabilizing element 1060. This arrangement provides one less assembly step, e.g., assembly ofbacking material, and less material is provided, thereby reducing costs.

] Figs. 185—189 illustrate another embodiment of a mask system 2610. As illustrated, the mask system 2610 is ntially similar to the mask system 1010 described above. In contrast, [the mask system 2610 may include lower stabilizing elements 2560 such as those shown in Figs. 182-184. Also, the mask system 2610 may have a "large:' size, wherein D1 is about 126 mm, D2 is about, 119 mm, D3 is about 151 mm, D4 is about 120 mm, and D5 is about 349 mm. These dimensions are merely exemplary and other dimensions are le depending on application, e.g., size.

Figs. 190-193 illustrate another embodiment of an elbow 2751 for a mask system. In this embodiment, the elbow 2751 may be a rib formed from a thicker wall n ofthe elbow.

Figs. 194-196 illustrate another embodiment of a clip member 2853 for securing an AAV to an elbow. In this embodiment, the clip member 2853 may include an e raised potion that s the shape of the vent.

Fig. 197 illustrates another embodiment of a mouth cushion 3072 with a "boomerang profile". Specifically, the mouth cushion 3072 es a chin section 3015 that is shaped like a boomerang or an inverted U and is designed to rest between the lower lip and the mental protuberance of the t in use. A full-face cushion including a boomerang profile is disclosed in US. Patent ation No. 10/655,622, filed September 5, 2003, which is incorporated herein by reference in its entirety.

While the ion has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the sed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope ofthe invention. Also, the s embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. In addition, while the invention has particular application to patients who suffer fiom OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, es, morbid obesity, stroke, tric surgery, etc.) can derive benefit fiom the above teachings.

Moreover, the above teachings have applicability with patients and non-patients alike in non- medical applications.

JAWS ref: 504290DIVA

Claims (40)

1. A headgear assembly to secure a mask system to a patient to receive positive airway pressure therapy, the headgear assembly comprising: a crown strap constructed and arranged to be soft, flexible and elastic in use; a first top strap portion and a second top strap portion that are configured to in use extend from said crown strap above the patient’s ears for connection with an upper portion of a mask frame; a first bottom strap portion and a second bottom strap portion that are configured to in use extend from said crown strap below the patient’s ears for connection with a lower portion of the mask frame; and wherein the first bottom strap portion and the second bottom strap portion are constructed and arranged to remain primarily on the bony part of the patient’s skull in use and thereby to substantially avoid the muscle and tendon of the patient’s head and neck; and wherein at least said crown strap is constructed at least in part from a two-dimensional first ar section, and a two-dimensional second headgear n, the two-dimensional first and second headgear sections being attached to one another so as to e the crown strap with a shape to cup at least a portion of the parietal bone and at least a portion of the occipital bone of the patient’s head in use, and thereby to provide a three-dimensional anatomically-shaped headgear assembly.

2. The headgear assembly according to claim 1, wherein the two-dimensional first ar section includes crown strap portions and the two-dimensional second headgear section includes crown strap portions, and wherein the respective crown strap portions cooperate to form the crown strap and to e it with a substantially round shape to thereby cup the parietal bone and occipital bone of the patient’s head in use.

3. The headgear assembly ing to claim 2, wherein the two-dimensional first ar section includes a first bridge strap n attached to a first crown strap portion of the JAWS ref: 504290DIVA two-dimensional first headgear section and to the first top strap n, and the twodimensional first headgear section includes a second bridge strap portion attached to a second crown strap portion of the two-dimensional first headgear n and to the second top strap portion.

4. The headgear assembly according to any one of claims 1 to 3, further comprising upper stabilizing straps provided between the top strap portions and the frame, and lower izing straps provided between the bottom strap ns and the frame.

5. The headgear assembly according to claim 4, wherein each of the upper and lower stabilizing straps includes a substantially rigid yoke section attached to a flexible material g.

6. A method of forming a headgear assembly to secure a mask system to a t to receive positive airway pressure therapy, the method sing the steps of: (a) forming a two-dimensional first ar section; (b) forming a two-dimensional second headgear section; wherein forming the two-dimensional first headgear section and the two-dimensional second headgear section involves forming: a crown strap constructed and arranged to be soft, flexible and c in use, a first top strap portion and a second top strap portion, each configured to extend from said crown strap above the patient’s ears in use for connection with an upper portion of a mask frame, a first bottom strap portion and a second bottom strap portion, each configured to extend from said crown strap below the patient’s ears in use for connection with a lower portion of the mask frame, and wherein forming the first bottom strap portion and the second bottom strap portion orientates the bottom strap portions with respect to the crown strap to remain primarily on the bony part of the patient’s skull in use and thereby to substantially avoid the muscle and tendon of the patient’s head and neck in use; and (c) attaching the two-dimensional first headgear section and the two-dimensional second headgear section to one another to provide the crown strap with a shape to cup at least a JAWS ref: DIVA portion of the parietal bone and at least a portion of the occipital bone of the patient’s head in use and thereby to form a three-dimensional anatomically-shaped headgear assembly.

7. The method according to claim 6, n forming the crown strap involves forming crown strap portions of the two-dimensional first headgear section and crown strap ns of the two-dimensional second headgear n which in use cooperate with each other to form the crown strap and provide it with a substantially round shape to thereby cup at least a portion of the tal and the parietal bone of the patient’s head in use.

8. The method according to claim 7, wherein forming the two-dimensional first headgear n includes forming a first bridge strap portion attached to the first top strap portion and a first crown strap portion of the two-dimensional first headgear section, and forming a second bridge strap portion attached to the second top strap portion and a second crown strap portion of the two-dimensional first ar section.

9. The method according to claim 8, wherein forming the two-dimensional first headgear section includes forming the first top strap portion, the second top strap portion the first crown strap portion of the two-dimensional first headgear section, the second crown strap portion of the two-dimensional first ar section, the first bridge strap portion, and the second bridge strap portion from the same piece of material.

10. The method according to either one of claims 8 or 9, further including the steps of separating the first bridge strap portion from the first top strap portion and separating the second bridge strap portion from the second top strap portion, reattaching the first bridge strap portion to the first top strap n in a different location, and reattaching the second bridge strap portion to the second top strap portion in a different location, to thereby form a three-dimensional first headgear section.

11. The method according to claim 8, wherein forming the two-dimensional first headgear section includes forming the first bridge strap portion attached to the first crown strap JAWS ref: 504290DIVA portion of the two-dimensional first headgear section, forming the second bridge strap portion ed to the second crown strap portion of the two-dimensional first headgear n, and separating the first bridge strap portion from the first top strap portion and separating the second bridge strap portion from the second top strap portion.

12. The method ing to claim 11, including the steps of reattaching the first bridge strap portion to the first top strap portion at a different location, and reattaching the second bridge strap portion to the second top strap portion at a different location to thereby form a three-dimensional first headgear section.

13. The method according to claim 8, the method including the step of separating the first bridge strap n from the first crown strap portion of the two-dimensional first headgear section, and ting the second bridge strap portion from the second crown strap portion of the two-dimensional first headgear section.

14. The method according to claim 13, including the step of ching the first bridge strap portion of the two dimensional first headgear section to the first crown strap portion of the mensional first headgear section at a different location and reattaching the second bridge strap portion of the two-dimensional first headgear section to the second crown strap portion of the two-dimensional first headgear section at a different location to thereby form a three-dimensional first headgear section.

15. The method according to claim 8, including the step of separating the bridge strap portions from the respective top strap portions, and reattaching the first bridge strap portion to the first top strap portion at a different location, and reattaching the second bridge strap portion to the second top strap portion at a different location to thereby form a dimensional first headgear section.

16. The method according to any one of claims 7 to 15, wherein g the ensional second headgear section includes forming the first bottom strap portion and the second bottom strap portion and the crown strap portions of the two-dimensional second headgear section. JAWS ref: 504290DIVA

17. The method according to claim 16, n attaching the two-dimensional first headgear section and two-dimensional second headgear section to one another es attaching an end of the crown strap portions of the two-dimensional first headgear section and an end of the crown strap portions of the two-dimensional second headgear section to one

18. The headgear assembly according to claim 1, wherein the first top strap portion, the second top strap portion, a first bridge strap portion, a second bridge strap portion and crown strap ns are constructed from the same piece of material; and wherein the first bottom strap n, the second bottom strap portion and crown strap portions are constructed from the same piece of material.

19. The headgear assembly according to claim 18, wherein the first bridge strap portion is attached to the first top strap portion and to the first crown strap portion of the twodimensional first headgear section to form a three-dimensional first headgear section.

20. The headgear assembly according to claim 19, wherein the second bridge strap n is attached to the second top strap portion and to the second crown strap portion of the ensional first headgear section to form the three-dimensional first headgear section.

21. The headgear assembly according to any one of claims 1 to 5 or 18 to 20, wherein the first top strap portion includes a first top strap fastener configured to couple the first top strap portion to the upper portion of the mask frame.

22. The headgear assembly according to claim 21, wherein the first top strap fastener is a loop and hook type fastener.

23. The headgear assembly according to any one of claims 1 to 5 or 18 to 22, wherein the second top strap portion includes a second top strap fastener configured to couple the second top strap portion to the upper portion of the mask frame. JAWS ref: 504290DIVA

24. The headgear assembly of claim 23, wherein the second top strap fastener is a loop and hook type fastener.

25. The headgear assembly ing to any one of claims 1 to 5 or 18 to 24, wherein the first bottom strap portion includes a first bottom strap fastener configured to couple the first bottom strap portion to the lower portion of the mask frame.

26. The headgear assembly according to claim 25, wherein the first bottom strap fastener is a loop and hook type fastener.

27. The headgear assembly according to any one of claims 1 to 5 or 18 to 26, n the second bottom strap portion includes a second bottom strap fastener configured to couple the second bottom strap n to the lower n of the mask frame.

28. The ar assembly according to claim 27, wherein the second bottom strap fastener is a loop and hook type fastener.

29. The headgear assembly according to any one of claims 1 to 5 or 18 to 28, wherein the crown strap is ucted from at least two segments of soft, flexible material.

30. The headgear assembly according to any one of claims 1 to 5 or 18 to 29, wherein at least a portion of the crown strap has a width of 18mm.

31. The headgear assembly according to any one of claims 1 to 5 or 18 to 30, wherein a portion of the top strap portions has a first elasticity and a n of the bottom strap portions has a second elasticity, and wherein said first elasticity and said second elasticity are different to each other.

32. The headgear assembly according to any one of claims 1 to 5 or 18 to 31, wherein the crown strap forms a substantially round aperture which overlays the crown of a patient’s head in use. JAWS ref: 504290DIVA

33. The headgear assembly according to any one of claims 1 to 5 or 18 to 32, wherein the first top strap portion and the second top strap portion are configured to extend across the patient’s forehead in use.

34. The method according to claim 6, wherein the step of forming the two-dimensional first headgear section forms the first and second top strap portions, a first bridge strap portion and a second bridge strap n, and crown strap portions of the two-dimensional first headgear section from the same piece of al; and wherein forming the ensional second headgear section forms the first and second bottom strap portions and crown strap portions of the two-dimensional second headgear section from the same piece of material.

35. The method according to claim 34, further comprising the steps of separating the first bridge strap portion from the first top strap portion of the two-dimensional first headgear section and separating the second bridge strap portion from the second top strap portion of the two-dimensional first headgear section, and reattaching the first bridge strap portion to the first top strap portion of the two dimensional first headgear section in a different location and ching the second bridge strap portion to the second top strap portion of the two-dimensional first ar section in a ent location to thereby form a three-dimensional first headgear section.

36. The method according to any one of claims 6 to 17 or 34 to 35, wherein the crown strap is formed such that at least a portion of the crown strap has a width of 18mm.

37. The method according to any one of claims 6 to 17, or 34 to 36, including the step of selecting the respective materials from which the two-dimensional first headgear section and the mensional second headgear n are formed so that the twodimensional first headgear section and the two-dimensional second ar section have a different elasticity to each other. JAWS ref: 504290DIVA

38. The method according to any one of claims 6 to 17, or 34 to 37, wherein forming the crown strap forms a substantially round aperture to overlay the crown of a patient’s head in use.

39. The method according to any one of claims 6 to 17, or 34 to 38, wherein forming the first top strap portion and the second top strap portion orientates them to extend across a patient’s forehead in use.

40. The method according to any one of claims 6 to 17, or 34 to 39, wherein the crown strap is formed such that the shape of the crown strap in use fits snugly to a patient’s head t buckling.