(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`
`
`(43) International Publication Date
`21 May 2004 (21.05.2004)
`
`(10) International Publication Number
`
`PCT
`
`WO 2004/041341 A1
`
`(51) International Patent Classification7:
`A62B 18/08
`
`A61M 16/06,
`
`(21) International Application Number:
`PCT/AU2003/001 161
`
`(22) International Filing Date:
`5 September 2003 (05.09.2003)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/424,694
`
`8 November 2002 (08.11.2002)
`
`US
`
`(71) Applicant (for all designated States except US): RESMED
`LINHTED [AU/AU]; 97 Waterloo Road, North Ryde, New
`South Wales 2113 (AU).
`
`(74)
`
`(31)
`
`Amal, Shirley [AU/AU]; 29 Grace Avenue, Beecroft,
`New South Wales 2119 (AU). LITHGOW, Perry, David
`[AU/AU]; 9 Staff Avenue, Glenwood, New South Wales
`2768 (AU). GUNEY, Memduh [AU/AU]; 52 Eastgate
`Avenue, Killara, New South Wales 2071 (AU).
`
`Agents: DAVIDSON, Geoffrey, Robert et al.; Halford &
`Co., Level 7, 1 Market Street, Sydney, New South Wales
`2000 (AU).
`
`Designated States (national): AE, AG, AL, AM, AT, AU,
`AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU,
`CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD, GE, GH,
`GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC,
`LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW,
`MX, MZ, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC,
`SD, SE, SG, SK, SL, SY, TJ, TM, TN, TR, TT, TZ, UA,
`UG, US, UZ, VC, VN, YU, ZA, ZM, ZW.
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): AMARASINGHE,
`
`(34)
`
`Designated States (regional): ARIPO patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW),
`
`[Continued on next page]
`
`(54) Title: HEADGEAR ASSEMBLY FOR A RESPIRATORY MASK ASSEMBLY
`
`A respiratory mask
`(57) Abstract:
`assembly for delivering breathable gas to a
`patient includes a frame (12) and a headgear
`assembly (16) removably attachable to the
`frame. The headgear assembly includes a
`pair of side portions (18) and a rear portion
`(20)
`that
`interconnects the pair of side
`portions. The pair of side portions includes
`at least one strap (22,24). The rear portion
`has at least two layers of material. One
`of the layers of material has a more rigid
`construction than the other of the layers
`of material to resist compression of the at
`least one strap of the rear portion in a first
`direction which resists movement of the at
`
`least one strap of the rear portion in a first
`direction which resists movement of the at
`
`least one strap of the pair of said straps in
`the first direction.
`
`RMD 1029
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`
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`WO2004/041341A1||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||l
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`1
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`RMD 1029
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`WO 2004/041341 A1
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`||||||||||||||ll|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`Eurasian patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE,
`ES, FI, FR, GB, GR, HU, IE, IT, LU, MC, NL, PT, RO,
`SE, SI, SK, TR), OAPI patent (BF, BJ, CF, CG, CI, CM,
`GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`Published:
`
`— with international search report
`
`For two—letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes andAbbreviations” appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`
`2
`
`

`
`WO 2004/041341
`
`PCT/AU2003/001161
`
`HEADGEAR ASSEMBLY FOR A RESPIRATORY MASK ASSEIVIBLY
`
`CROSS-REFERENCE TO PRIORITY APPLICATIONS
`
`The present application claims priority to U.S. Provisional Application Serial No.
`
`60/424,694 filed November 8, 2002. This application is hereby incorporated herein by
`
`reference in its entirety.
`
`FIELD OF THE INVENTION
`
`The present invention relates to a headgear assembly for use in holding a respiratory
`
`mask assembly in position on a patient’s face, the mask assembly being used for treatment,
`
`eg, of Sleep Disordered Breathing (SDB) with Non-invasive Positive Pressure Ventilation
`
`(NPPV).
`
`BACKGROUND OF THE INVENTION
`
`Respiratory mask assemblies such as the Mirage® nasal mask assembly manufactured
`
`by RedMed Ltd. and used for treatment of SDB such as Obstructive Sleep Apnea (OSA) are
`
`typically held in position on a patient’s head by a headgear assembly. A headgear assembly
`
`typically includes a pair of side portions and a rear portion. The side portions are adapted to
`
`engage with the patient’s mask and the rear portion is adapted to engage the back of the
`
`patient’ s head.
`
`Headgear assemblies are structured to position and stabilize a patient interface, such as
`
`a nasal mask, on a patient's face so that a good seal can be maintained. In addition, the
`
`headgear assembly should be comfortable so that a patient can wear the mask assembly at
`
`night while they sleep. Many prior art headgear assemblies are uncomfortable to wear for long
`
`periods. It is desirable that one form of headgear assembly is suitable for a broad range of
`
`patients in order to reduce inventory, and ultimately reduce costs.
`
`Completely rigid headgear assemblies are ‘known, but they typically suffer from being
`
`uncomfortable to wear for long periods. In addition, because of their rigidity, they typically do
`
`not fit a broad range of patients, being suitable only for a subset.
`
`3
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`

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`WO 2004/041341
`
`PCT/AU2003/001161
`
`2
`
`For reasons of costs, it is desirable to be able to cut headgear assemblies from a flat
`
`piece of fabric or composite, yet in use the headgear assembly should conform to a complex
`
`three-dimensional shape. Hence a problem to overcome is to have a design of headgear
`
`assembly which can be easily manufactured by cutting or stamping, and yet in use be able to fit
`
`a wide range of head shapes and sizes.
`
`Known forms of headgear assemblies include the ResCapTM, ResCapTM II and
`
`M[RAGE® headgear, as shown in Figs. 11-16. These headgear assemblies are constructed
`
`from fabric or composite layers of fabric and neoprene. Because of the soft flexible nature of
`
`the straps in the headgear assembly, there is the possibility of some movement ofthe headgear
`
`assembly on the patient's head, particularly during the course of a night's sleep. Hence, while
`
`the headgear assembly may be initially correctly positioned on a patient's head, they may
`
`subsequently move to an incorrect position.
`
`A form of connector to enable the headgear assembly to engage with the patient’s mask
`
`is taught in U.S. Patent No. 6,374,826 (Gunaratnam et al.), the contents of which are hereby
`
`incorporated by reference.
`
`U.S. Patent No. 6,422,238 (Lithgow) shows a form of headgear assembly including a
`
`quick-release mechanism. The contents of the Lithgow patent are hereby incorporated by
`
`reference. The headgear assembly taught by Lithgow includes an upper and lower strap in
`
`each side portion extending between the patient’s face and the rear ofthe patient’s head. The
`
`upper straps lie above the ears on the patient’s head. The lower straps lie below the ears on the
`
`patient’s head.
`
`A problem which can occur with prior art mask assemblies, such as the mask
`
`assemblies shown i11 Figs. 11-16 and taught by Gunaratnam and Lithgow, is that the lower
`
`straps of the mask assemblies can ride up the patient’s head while in use and cause chafing and
`
`irritation of the lower portion of the patient’s ears.
`
`SUMMARY OF THE INVENTION
`
`One aspect ofthe present invention is directed towards a mask assembly having a
`
`headgear assembly that offers more comfort to the patient yet does not sacrifice functionality.
`
`4
`
`

`
`WO 2004/041341
`
`PCT/AU2003/001161
`
`3
`
`Another aspect ofthe present invention provides a respiratory mask assembly for
`
`delivering breathable gas to a patient. The respiratory mask assembly according to one
`
`embodiment includes a frame and a headgear assembly removably attachable to the frame.
`
`The headgear assembly includes a pair of side portions and a rear portion that interconnects the
`
`pair of side portions. The pair of side portions includes at least one strap. The rear portion has
`
`at least one strap constructed of at least two layers of material. One of the layers of material
`
`has a more rigid construction than the other of the layers of material to resist compression of
`
`the at least one strap of the rear portion in a first direction and thereby resist movement of the
`
`at least one strap of the pair of side straps in the first direction.
`
`Another aspect of the invention is to provide a means for maintaining flexible headgear
`
`straps of a mask assembly in correct relative position on a patient's head in use.
`
`Another aspect of the invention is to provide a comfortable headgear assembly for a
`
`mask assembly which fits a wide range of head shapes and sizes.
`
`Another aspect of the invention is to provide a comfortable headgear assembly of a
`
`mask assembly which fits a wide range of patients and can be cut from a flat piece of fabric.
`
`Other aspects, features and advantages of this invention will become apparent from the
`
`following detailed description when taken in conjunction with the accompanying drawings,
`
`which are part of this 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:
`
`Fig. 1 is a side view illustrating a mask assembly having a headgear assembly
`
`constructed in accordance with an embodiment of the invention mounted on a patient’s head;
`
`Fig. 2 is a rear view illustrating the headgear assembly of Fig. I mounted on a patient’s
`
`head;
`
`Fig. 3 is a rear perspective View illustrating the headgear assembly of Fig. I mounted
`
`on a patient’s head;
`
`5
`
`

`
`WO 2004/041341
`
`PCT/AU2003/001161
`
`Fig. 4 is a top View illustrating the headgear assembly of Fig. I laid flat;
`
`4
`
`Fig. 5 is an enlarged top View illustrating an embodiment of a stiffener of the headgear
`assembly of Fig. 1;
`
`Fig. 6 is an enlarged photographic top View illustrating an embodiment of a stiffener of
`
`the headgear assembly of Fig. 1;
`
`Fig. 7 is an enlarged photographic side View illustrating an embodiment of a stiffener of
`
`the headgear assembly of Fig. 1;
`
`Fig. 8 is a top view illustrating the headgear assembly of Fig. I laid flat and showing
`
`typical dimensions of an embodiment (R-radius);
`
`Fig. 9 is a top View illustrating an embodiment of a stiffener of the headgear assembly
`
`of Fig. 1 and showing typical dimensions of an embodiment (R-radius);
`
`Fig. 10 is a rear View illustrating a headgear assembly constructed in accordance with
`
`another embodiment of the invention mounted on a patient’s head;
`
`Fig. 11 is a side View of a prior art ResCapTM headgear assembly;
`
`Fig. 12 is a rear View of a prior art ResCapTM headgear assembly;
`
`Fig. 13 is a side View of a prior art ResCapTM II headgear assembly;
`
`Fig. 14 is a rear View of a prior art ResCapTM II headgear assembly;
`
`Fig. 15 is a side View of a prior art MIRAGE® headgear assembly; and
`
`Fig. 16 is a rear View of a prior art M1RAGE® headgear assembly.
`
`DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
`
`Fig. 1 shows a respiratory mask assembly 10 that includes a frame 12 and a cushion 14
`
`that may be permanently or removably connected to the frame 12. A headgear assembly 16 is
`
`removably attached to the frame 12 and is structured to maintain the frame 12 and cushion 14
`
`in a desired adjusted position on a patient’s face. In the illustrated embodiment, the mask
`
`assembly 10 is a nasal mask structured to deliver breathable gas to a patient’s nose. However,
`
`6
`
`

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`WO 2004/041341
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`PCT/AU2003/001161
`
`5
`
`the mask assembly 10 may be a nasal and mouth mask or the mask assembly 10 may be a full-
`
`face mask.
`
`As shown in Figs. 1-4, the headgear assembly 16 includes two side portions 18 with a
`
`rear portion 20 connecting the side portions 18. Each side portion 18 comprises an upper side
`
`strap 22 and a lower side strap 24. The rear portion 20, which interconnects the two side
`
`portions 18, includes a curved upper strap 26, a lower strap 28, and an intermediate strap
`
`arrangement 30 therebetween. The intermediate strap arrangement 30 is generally H-shaped
`
`and has a pair ofupper straps 32, a pair of lower straps 34, and a cross-bar strap 36. The upper
`
`straps 32 are angled with respect to the curved upper strap 26 and the lower straps 34 are
`
`angled with respect to the lower strap 28. However, the straps of the headgear assembly 16
`
`may have any suitable configuration to maintain the frame 12 and cushion 14 in a desired
`
`adjusted position on a patient’s face. For example, the upper strap 26 may not be curved with
`
`respect to the upper straps 22 and the intermediate strap arrangement 30 may have any suitable
`
`shape, i.e., not H-shaped.
`
`Each upper side strap 22 is removably connected to an upper portion of the frame 12
`
`and each lower side strap 24 is rernovably connected to a lower portion of the frame 12. As
`
`shown in Fig. 4, the end portion 38, 40 of each upper and lower strap 22, 24, respectively, has
`
`a reduced width that enables each upper and lower strap 22, 24 to be wrapped around a
`
`respective clip structure 42 (see Fig. 1) provided on the frame 12. Fastening of the upper and
`
`lower straps 22, 24 to the frame 12 may be assisted by use of a hook and loop material, such as
`
`VELCRO®. As shown in Fig. 4, the free end of each upper and lower strap 22, 24 includes a
`
`strip of hook material 44 attached thereto by stitching, for example. The upper and lower
`
`straps 22, 24 are constructed of a loop material that engages the strip of hook material 44 when
`
`the upper and lower straps 22, 24 are connected to the frame 12.
`
`However, the upper and lower straps 22, 24 may be connected to the frame 12 in any
`
`other suitable manner. For example, the upper and lower straps 22, 24 may include locking
`
`clips attached thereto that are adapted to interlockingly engage with the flame 12.
`
`Alternatively, the upper and lower straps 22, 24 may be magnetically coupled with the frame
`
`12 so as to interconnect the frame 12 and headgear assembly 16. Further, the frame 12 may
`
`include a forehead support movably mounted to an upper portion thereof. In such an
`
`7
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`

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`WO 2004/041341
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`6
`
`arrangement, the upper straps 22 may be removably connected to clip structures provided on
`
`the forehead support.
`
`The straps of the headgear assembly 16 are constructed from a soft, flexible composite
`
`material such as Breathe-O-PreneTM manufactured by Accumed Technologies, Inc. As shown
`
`in Fig. 7, the straps include two layers of material A, B wit11 one of the layers A having a loop
`
`material to facilitate the connection with the strip of hook material 44 provided on the free ends
`
`the upper and lower straps 22, 24. However, the straps may be constructed from any other
`
`suitable soft, flexible material.
`
`In the illustrated embodiment, a stiffener 46 is attached to the rear portion 20 of the
`
`headgear assembly 16. As shown in Figs. 2 and 4-6, the stiffener 46 has a general C-shape
`
`including a body 48 and a pair of arm members 50. The stiffener 46 is attached to the H-
`
`shaped intennediate strap arrangement 30 such that the body 48 of the stiffener 46 extends
`
`along the cross-bar strap 36 and the arm members 50 of the stiffener 46 extend along
`
`respective lower straps 34. The body 48 has a width that is greater than a width of the arm
`
`members 50. Further, the free ends of the arm members 50 have a greater width than the
`
`remaining portion of the arm members 50. However, the stiffener 46 may have any suitable
`
`structure and width dimensions. The stiffener 46 is constructed from a semi-rigid skin-
`
`compatible material such as thermoplastics, e.g., nylon or polyester or a thermoplastic
`
`elastomer, e.g. santoprene. The stiffener 46 has a thickness in the range of 0.8 mm to 1.5 mm,
`
`preferably 1 mm.
`
`The stiffener 46 is attached to the corresponding straps 34, 36 with adhesives, stitching,
`
`or other known attachment mechanisms or by semi-permanent means such as Velcro, pocket
`
`sleeve, etc. As shown in Fig. 5, the stiffener 46 is secured to the straps 34, 36 by stitching
`
`around the periphery of the stiffener 46. As shown in Fig. 6, the stiffener 46 is secured to the
`
`straps by stitching an intermediate portion of the stiffener 46. Fig. 7 is an enlarged View that
`
`illustrates the stiffener 46 secured to the straps by stitching. The stitch line is in the range of 2-
`
`3 mm, preferably 2.5 mm, from the edge of the stiffener 46.
`
`The stiffener 46 is narrower than the straps 34, 36 so that when the stiffener 46 is
`
`attached to the straps 34, 36, the softer material of the straps 34, 36 extends beyond the more
`
`rigid material of the stiffener 46, thereby preventing or at least reducing the opportunity for
`
`8
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`WO 2004/041341
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`PCT/AU2003/001161
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`7
`
`contact between the patient and the more rigid material of the stiffener 46 that could cause
`
`irritation or discomfort.
`
`The stiffener 46 adds to the rigidity of the headgear assembly 16 in certain planes and
`
`directions, which assists in stabilizing the mask assembly l0 on the head of the patient during
`
`use. In other planes and directions, the headgear assembly 16 has a different rigidity.
`
`For example, the stiffener 46 reduces the flexibility of the straps 34, 36 at the back of
`
`the patient’s head along the direction of arrow A or in a reverse direction of arrow A, as shown
`
`in Fig. 2. The presence of the stiffener 46 stops compression of the straps 34, 36 along the
`
`reverse direction of arrow A. In this way, the straps 34, 36 and stiffener 46 should be able to
`
`resist the riding up of the lower straps 24 towards the patient’s ears 52. In general, the straps
`
`34, 36 and stiffener 46 should be able maintain their positions with respect to the head of the
`
`patient when the straps 34, 36 and stiffener 46 are connected to the frame 12. Thus, the
`
`likelihood that the lower straps 24 will ride up into the lower portion of the cars 52 of the
`
`patient is reduced.
`
`Further, the headgear assembly 16 is shaped to avoid interference with the patient’s
`
`ears 52. In particular, the upper side strap 22 is connected to the frame 12 above the patient’s
`
`eyes and patient’s cars 52. The lower side strap 24 is connected to the frame 12 and extends
`
`below the patient’s ear 52. The upper straps 32 and lower straps 34 interconnect the upper and
`
`lower straps 22, 24 and are angled sufficiently away from the patient’s cars 52. Also, the upper
`
`and lower straps 32, 34 are of sufficient length to space the upper and lower straps 22, 24 from
`
`the patient’s ears 52. Due to the added rigidity provided by the stiffener 46, all the straps of
`
`the headgear assembly 16 are better able to maintain a predetermined shape. The thickness of
`
`the stiffener 46 may vary across its profile to modify flexibility characteristics, for example,
`
`thicker regions may be stiffer.
`
`On the other hand, a certain degree of flexibility of the headgear assembly 16 is
`
`provided such that variations in patient physiology can be accommodated to a certain degree.
`
`For example, the lower strap 28 has relatively more flexibility along arrow direction B or its
`
`reverse direction than straps 34, 36 with the stiffener 46 attached.
`
`The H-shaped intermediate strap arrangement 30 of the headgear assembly 16 also
`
`helps maintain the headgear assembly 16 in a desired adjusted position on the patient. As
`
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`WO 2004/041341
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`8
`
`shown in Fig. 1, the curved upper strap 26 extends across a rear upper portion of the patient’s
`
`head and the lower strap 28 and cross-bar strap 36 extend across a rear lower portion ofthe
`
`patient’s neck and head, respectively. More specifically, the curved upper strap 26 is
`
`structured to engage a posterior portion of the parietal bone of the patient’s head in order to
`
`prevent downward movement of the headgear assembly 16 opposite the direction of arrow A in
`
`Fig. 2. The cross-bar strap 36 is structured to engage a lower portion of the occipital bone of
`
`the patient’s head and the lower strap 28 is structured to engage a rear upper portion ofthe
`
`patient’s neck. As a result, the cross-bar strap 36 and the lower strap 28 prevent upward
`
`movement of the headgear assembly 16 in the direction of arrow A in Fig. 2. Moreover, the
`
`stiffener 46 is structured to resist the riding up of the lower straps 34 and hence the lower
`
`straps 24 towards the patient’s ears 52. However, the intermediate strap arrangement 30 may
`
`have any suitable configuration to maintain the frame 12 and cushion 14 in a desired adjusted
`
`position on a patient’s face.
`
`Further, the straps 28, 34, and 36 form an opening 54 therebetween that can
`
`accommodate any skin folds of a patient which may extend through the opening 54.
`
`Specifically, movement of the patient’s head can create a fold of skin adj acent the patient’s
`
`neck. The straps 28, 34, and 36 are structured and positioned on the patient’s head such that
`
`any skin folds will extend through the opening 54 and not adversely affect the positioning of
`
`r,
`
`the headgear assembly 16 on the patient’s head. The opening 54 formed between the straps 28,
`
`34, and 36 may have any suitable shape, i.e., trapezoidal or non-trapezoidal shape. The
`
`reduced width of strap 28 allows it to stretch over the fatter lower neck, that is, fl'1Cl‘C is a
`
`different stretch between strap 36 and strap 28.
`
`Fig. 8 illustrates dimensions of an embodiment of the headgear assembly 16. For
`
`example, the overall length of the headgear assembly 16 is in the range of 640-680 mm,
`
`preferably 660 mm and the overall height of the headgear assembly 16 is in the range of 175-
`
`215 mm, preferably 196.1 mm. The upper straps 32 are angled in the range of 40-50°,
`
`prcfcrably 45°, with respect to the upper straps 22 and have a width in the range of 16-22 mm,
`
`preferably 19 mm. The curved upper strap 26 has a radius of curvature in the range of 145-170
`
`mm, preferably 166 mm. Further, the lower strap 28 has a width in the range of 17-23 mm,
`
`preferably 20 mm, and the end portions 38, 40 of the upper and lower straps 22, 24 have a
`
`width in the range of 16-23 mm, preferably 19 mm. In an embodiment of the headgear
`
`assembly 16, the dimensions illustrated in Fig. 8 vary J:10%.
`
`10
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`9
`
`Fig. 9 illustrates dimensions of an embodiment of the stiffener 46. For example, the
`
`overall length of the stiffener 46 is in the range of 100-140 mm, preferably 120 mm and the
`
`overall height of the stiffener 46 is in the range of 40-80 mm, preferably 62.8 mm. The arm
`
`members 50 are angled in the range of 110-140°, preferably 125°, with respect to the body 48.
`
`In an embodiment of the stiffener 46, the dimensions illustrated in Fig. 9 vary i10%.
`
`Fig. 10 illustrates another embodiment of the stiffener, indicated as 246. In this
`
`embodiment, the stiffener is in the form of a pair of arcuate-shaped stiffeners 246. Each
`
`stiffener 246 extends along the upper strap 32, across the cross-bar strap 36, and along the
`
`lower strap 34. Similar to the stiffener 46, the stiffeners 246 reduces the flexibility of the
`
`10
`
`straps 32, 34, and 36 at the back of the patient’s head along the direction of arrow A or in a
`
`reverse direction of arrow A, so as to resist the riding up of the lower straps 24 towards the
`
`patient’s ears 52.
`
`The straps of the headgear assembly 16 and the stiffener 46, 246 may be formed of a
`
`single material, so long as patient comfort and the appropriate rigidity/flexibility are
`
`15
`
`maintained.
`
`It can thus be appreciated that the aspects of the present invention have been fiilly and
`
`effectively accomplished. The foregoing specific embodiments have been provided to
`
`illustrate the structural and functional principles of the present invention, and are not intended
`
`to be limiting. To the contrary, the present invention is intended to encompass all
`
`20
`
`modification, alterations and substitutions within the spirit and scope of the present invention.
`
`11
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`WO 2004/041341
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`WHAT IS CLAIMED IS:
`
`1.
`
`A headgear assembly for attachment to a frame of a respiratory mask assembly
`
`for delivering breathable gas to a patient, comprising:
`
`a pair of side portions; and
`
`a rear portion that interconnects the pair of side portions, the pair of side
`
`portions including at least one strap,
`
`wherein the rear portion has at least one strap constructed of two layers of
`
`material, one of the layers of material having a more rigid construction than the other of the
`
`layers of material to resist compression of the at least one strap of the rear portion in a first
`
`direction which resists movement of the at least one strap of the pair of side straps in the first
`
`direction.
`
`2.
`
`The headgear assembly according to claim 1, wherein each ofthe pair of side
`
`portions includes an upper strap removably attachable to an upper portion of the frame and a
`
`lower strap removably attachable to a lower portion of the frame, the upper strap extending
`
`above the patient’s ear and the lower strap extending below the patient’s ear, and
`
`wherein the rear portion includes an upper strap, a lower strap, and an
`intermediate strap arrangement between the upper and lower straps ofthe rear portion, the
`
`intermediate strap arrangement including the at least one strap constructed of two layers of
`
`material.
`
`3.
`
`The headgear assembly according to claim 2, wherein the at least one strap of
`
`the intennediate strap arrangement resists movement of the lower strap of each of the pair of
`
`side portions in the first direction which is towards the patient’s ear.
`
`4.
`
`The headgear assembly according to any one of claims 2 or 3, wherein the at
`
`least one strap ofthe intermediate strap arrangement includes a stiffener attached thereto that
`
`adds rigidity of the at least one strap of the intermediate strap arrangement.
`
`!5\OOO\lO\U1-l>UJl\J!-‘
`
`l 2 3 4 5 6 7 8
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`12
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`

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`WO 2004/041341
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`PCT/AU2003/001161
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`11
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`5.
`
`The headgear assembly according to any one of claims 2-4, wherein the
`
`intermediate strap arrangement includes a pair of upper straps angled with respect to the
`
`upper strap of the rear portion, a pair of lower straps angled with respect to the lower strap of
`
`the rear portion, and a cross-bar strap that extends between the upper and lower straps of the
`
`intermediate strap arrangement.
`
`6.
`
`The headgear assembly according to any one of claims 4 or 5, wherein the
`
`stiffener is generally C-shaped including a body that extends along the cross-bar strap and a
`
`pair of arm members that extend along respective lower straps of the intermediate strap
`
`arrangement.
`
`7.
`
`The headgear assembly according to any one of claims 4-6, wherein the
`
`stiffener has an overall length in the range of 100-140 mm, preferably 120 mm, an overall
`
`height in the range of 40-80 mm, preferably 62.5 mm, and the arm members are angled in the
`
`range of 110-140“, preferably 125°, with respect to the body.
`
`8.
`
`The headgear assembly according to any one of claims 4-7, wherein the
`
`stiffener comprises a pair of arcuate-shaped stiffeners, each ofthe pair of stiffeners extending
`
`along a respective upper strap and lower strap of the intermediate strap arrangement.
`
`9.
`
`The headgear assembly according to any one of claims 5-8, wherein the cross-
`
`bar strap of the intcmiediatc strap arrangement, the pair of lower straps of the intermediate
`
`strap arrangement, and the lower strap of the rear portion define an opening therebetween that
`
`is adapted to allow folds of the patient’s skin extend therethrough.
`
`10.
`
`The headgear assembly according to any one of claims 1-9, wherein an overall
`
`length of the headgear assembly is in the range of 640-680 mm, preferably 660 mm, and an
`
`overall height of the headgear assembly is in the range of 175-215 mm, preferably 196.1 mm.
`
`11.
`
`The headgear assembly according to any one of claims 2-10, wherein the pair
`
`of upper straps of the intermediate strap arrangement are angled with respect to the upper
`
`13
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`

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`WO 2004/041341
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`PCT/AU2003/001161
`
`12
`
`strap of the rear portion in the range of 40-50°, preferably 45°, and have a width in the range
`
`of 16-22 mm, preferably 19 mm.
`
`12.
`
`The headgear assembly according to any one of claims 2-1], wherein the
`
`upper strap of the rear portion is curved and has a radius of curvature in the range of 145-170
`
`mm, preferably 166 mm.
`
`13.
`
`The headgear assembly according to any one of claims 4-12, wherein the
`
`stiffener has a thickness in the range of 0.8 mm to 1.5 mm, preferably 1.0 mm.
`
`14.
`
`The headgear assembly according to any one of claims 4-13, wherein the
`
`stiffener is attached to the at least one strap of the intermediate strap arrangement by at least
`
`one of stitching, placing it in a pocket which is permanently attached to the at least one strap
`
`of the intermediate strap arrangement, and utilizing a hook and loop fastening system.
`
`15.
`
`The headgear assembly according to any one of claims 1-14, wherein the at
`
`least one strap of the rear strap portion includes a stiffener attached thereto that adds rigidity
`
`of the at least one strap of the rear portion.
`
`16.
`
`The headgear assembly according to claim 15, wherein the at least one strap of
`
`the rear strap portion with the stiffener attached thereto resists movement of the at least one
`
`strap ofthe pair of side straps in the first direction which is towards the patient’s ear.
`
`17.
`
`A headgear assembly for stabilizing and positioning a respiratory mask
`
`assembly on a patient's head, comprising:
`
`a pair of side straps;
`
`at least two rear straps,
`
`at least one of the pair of side straps and at least two rear straps having a
`
`flexible strap; and
`
`a stiffener positioned between the at least one flexible strap and another of the
`
`14
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`

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`WO 2004/041341
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`PCT/AU2003/001161
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`13
`
`pair of side straps and at least two rear straps, the stiffener being structured to maintain the at
`
`least one flexible strap in correct relative position on the patient's head in use.
`
`18.
`
`A headgear assembly for stabilizing and positioning a respiratory mask
`
`assembly on a patient's head, comprising:
`
`a pair of side straps; and
`
`at least two rear straps,
`
`wherein at least one of the at least two rear straps has a curved portion with a
`
`radius in the range of 145-170 mm.
`
`11
`
`12
`
`O\U1-hUJI\)I--\
`
`19.
`
`A respiratory mask assembly for delivering breathable gas to a patient
`
`comprising a frame and a headgear assembly according to any one of claims 1-1 8.
`
`15
`
`15
`
`

`
`WO 2004/041341
`
`16110N300mMTCP
`
`16
`
`

`
`WO 2004/041341
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`PCT/AU2003/001161
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`17
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`

`
`WO 2004/041341
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`PCT/AU2003/001161
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`18
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`

`
`WO 2004/041341
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`PCT/AU2003/001161
`
`3L
`
`O
`
`Q‘
`LG
`00
`(\l
`
`O1
`
`-D
`
`19
`
`

`
`WO 2004/041341
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`PCT/AU2003/001161
`
`5/16
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`20
`
`20
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`WO 2004/041341
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`PCT/AU2003/001161
`
`21
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`

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`22
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`

`
`WO 2004/041341
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`16110M3002U./ATCP
`
`23
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`

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`WO 2004/041341
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`PCT/AU2003/001161
`
`24
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`

`
`WO 2004/041341
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`PCT/AU2003/001161
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`25
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`

`
`26
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`WO 2004/041341
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`PCT/AU2003/001161
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`FIG. 12
`RELATED ART
`
`27
`
`

`
`28
`
`

`
`WO 2004/041341
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`PCT/AU2003/001161
`
`FIG. 14
`RELATED ART
`
`29
`
`

`
`WO 2004/041341
`
`PCT/AU2003/001161
`
`FIG. 15
`RELATED ART
`
`30
`
`

`
`WO 2004/041341
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`PCT/AU2003/001161
`
`j F
`
`IG. 16
`RELATED ART
`
`31
`
`

`
`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/AU03/01 161
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`Int. C1. 7=
`
`Accordin
`
`B.
`
`A61M 16/06, A62B 18/08
`
`to International Patent Classification IPC or to both national classification and IPC
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`AU IPC_ A6lM 16/06, A62B 18/08
`-
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`'
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`DWPI IPC A61M 16/06, A62B 18/08 and Keywords (harness or headgear or fiam, strap) and like terms
`
`C.
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to
`claim No.
`
`WO 02/47749 Al (RESMED LTD) 20 June 2002
`page 10, lines 12-17 Figs. 4,i6B
`
`WO 02/47763 A1 (MSA AUER GMBH) 20 June 2002
`abstract Fig. 1
`
`W0 02/07806 Al (MAP MEDIZINTECHNIK FUR ARZT UND PATIENT Gl\/[BH &
`CO KG) 31 January 2002
`abstract Figs. 2-5
`
`i:| Further documents are listed in the continuation of Box C
`Special categories of cited documents:
`docinnent defining the general state of the art
`which is not considered to be of particular
`relevance
`earlier application or patent but published on or
`after the international filing date
`
`"Tu
`
`"X"
`
`See patent family annex
`
`later document published after the international filing date or priority date
`and not in eonflict with the application but cited to understand the principle
`or theory underlying the invention
`document of particular relevance; the c