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`US 20060042629Al
`
`(19) United States
`(12) Patent Application Publication
`Geist
`
`(10) Pub. No.: US 2006/0042629 Al
`Mar. 2, 2006
`(43) Pub. Date:
`
`(54) MASK, MASK SHELL AND SEAL WITH
`IMPROVED MOUNTING, MASK SEAL,
`METHOD OF MASK MANUFACTURE AND
`MASK WITH REDUCED EXHALATION
`NOISE
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`(2006.01)
`A62B 18/08
`(52) U.S. Cl. ........ 128/206.24; 128/206.21; 128/205.25;
`128/206.26; 128/206.27
`
`(75)
`
`Inventor: Leroy D. Geist, Parker, CO (US)
`
`(57)
`
`ABSTRACT
`
`Correspondence Address:
`R. GALE RHODES, ESQ. I MOSER IP LAW
`GROUP
`1040 BROAD STREET
`2ND FLOOR
`SHREWSBURY, NJ 07702 (US)
`
`(73)
`
`Assignee: Vital Signs Inc.
`
`(21)
`
`Appl. No.:
`
`10/932,849
`
`(22)
`
`Filed:
`
`Sep. 1, 2004
`
`A mask, a mask shell and seal provided with cooperative
`mounting members for mounting the seal to the shell,
`method of manufacturing such mask, mask shell and seal, a
`mask including a plurality of headstraps and a headstrap
`retention bracket for mounting the headstraps removably to
`the mask, a mask seal including an embedded seal mounting
`member for mounting the seal to a mask shell, a mask shell
`including a malleable member in its peripheral portion
`which may be deformed to customize the mask seal to a
`person's face, and a mask with a plurality of angular vent
`holes for reducing the noise of a mask wearer's exhaled
`breath and for directing the exhaled breath away substan(cid:173)
`tially parallel to the mask wearer's body.
`
`44
`
`25-15
`
`~228
`
`Page 1
`
`Fisher & Paykel Ex. 1208
`IPR Petition - USP 8,944,061
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 1 of 12
`
`US 2006/0042629 Al
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`14
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`
`Page 2
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 2 of 12
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`Patent Application Publication Mar. 2, 2006 Sheet 3 of 12
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`Patent Application Publication Mar. 2, 2006 Sheet 4 of 12
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`Patent Application Publication Mar. 2, 2006 Sheet 5 of 12
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`Patent Application Publication Mar. 2, 2006 Sheet 6 of 12
`
`US 2006/0042629 Al
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`40
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`33
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`Page 7
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 7 of 12
`
`US 2006/0042629 Al
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`
`Page 8
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 8 of 12
`
`US 2006/0042629 Al
`
`46
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`44
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`/14
`
`48
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`FIG. 7
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`
`Page 9
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 9 of 12
`
`US 2006/0042629 Al
`
`12
`
`38
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`32
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`
`Page 10
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 10 of 12
`
`US 2006/0042629 Al
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`33
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`Page 11
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 11 of 12
`
`US 2006/0042629 Al
`
`77
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`
`Page 12
`
`

`

`Patent Application Publication Mar. 2, 2006 Sheet 12 of 12
`
`US 2006/0042629 Al
`
`FIG. 17
`
`80
`
`FIG. 18
`
`Page 13
`
`

`

`US 2006/0042629 Al
`
`Mar. 2, 2006
`
`1
`
`MASK, MASK SHELL AND SEAL WITH
`IMPROVED MOUNTING, MASK SEAL, METHOD
`OF MASK MANUFACTURE AND MASK WITH
`REDUCED EXHALATION NOISE
`
`BACKGROUND OF THE INVENTION
`
`[0001] This invention relates generally to masks for sup(cid:173)
`plying breathable gas to a person, and more particularly,
`relates to a nasal CPAP (Continuous Positive Airway Pres(cid:173)
`sure) mask particularly useful for supplying pressurized
`breathing gas, such as oxygen, to a person in the treatment
`of obstructive sleep apnea.
`
`[0002] The prior art is replete with masks which are of
`many different sizes, structures and for use in many different
`applications. Many different full face masks covering both
`the nose and the mouth are known to the art, and many
`different nasal masks covering only the nose are known to
`the art. A typical mask may include a shell of relatively hard
`or stiff material and a seal mounted to the shell and for
`conforming to the contours of a person's face, surrounding
`the nose and/or mouth, and for engaging such contours in an
`air-tight or sealing engagement. Such shell and seal may be
`made of numerous materials known to the art and also
`known to the art are numerous methods and structures for
`mounting the seal to the shell.
`
`[0003] As is further known to the art, such masks typically
`include head gear comprising a plurality of heads traps which
`encircle the person's head and/or neck and which are adjust(cid:173)
`able to individualize the tension applied to the mask thereby
`individualizing the amount of force applied to the seal so
`that the seal will sealingly engage different contours of the
`faces of different people.
`
`[0004] As is further known, the shells of such prior art
`masks are provided with venting means, such as a hole or
`plurality of holes, for preventing the accumulation of carbon
`dioxide in the shell and for providing for the exiting of the
`person's exhaled breath. Such prior art venting can produce
`a noisy or turbulent air flow or jet of air which can impinge
`annoyingly on the mask wearer or onto nearby persons such
`as a sleep partner.
`
`[0005] Accordingly, it is believed that there is a need in the
`art for a mask having improved venting which reduces the
`noise level of the vented air and which directs the vented air
`away from the mask wearer thereby reducing discomfort to
`the mask wearer and annoyance to adjacent people such as
`a sleep partner.
`
`[0006] Referring more particularly to the above-noted
`obstructive sleep apnea treatment, typically, in the night time
`treatment of obstructive sleep apnea, a nasal mask is placed
`over a person's nose and forced into sealing engagement
`with the contours of the patient's face surrounding the nose
`by adjusting and tightening the above-noted headstraps. The
`mask is connected to a ventilator which supplies breathing
`gas to the patient for the night time obstructive sleep apnea
`treatment. Typically, the adjustable headstraps are mounted
`fixedly to the mask which requires the headstraps to be
`loosened or removed to free the person from the mask for
`movement during the night time such as going to the
`bathroom. Upon return and recommencement of the obstruc(cid:173)
`tive sleep apnea treatment, the mask must again be placed
`into sealing engagement with the face and the headstraps
`
`again readjusted or retightened. This loosening and re(cid:173)
`tightening of the headstraps is known to be quite annoying.
`
`[0007] Further, the mask, particularly the seal, must be
`cleaned and since, as noted, the mask is typically mounted
`fixedly to the headstraps, this makes cleaning more difficult
`than is desirable. Further, the cleaning of a mask or seal
`mounted fixedly to the headstraps can cause the headstraps
`to become wet and possibly suffer shrinkage or at least some
`structural or functional impairment.
`
`[0008] Accordingly, it is believed there is a need in the art
`for a new and improved mask mounted removably to the
`adjustable heads traps which permits the mask to be removed
`from the headstraps during the night time, freeing the person
`from the mask and ventilator and permitting the person to
`move about while the headstraps remain on the person's
`head, tightened and still individually adjusted to
`the
`patient's head. It is also believed there is a need in the art for
`such removable mask and headstrap combination which
`permits the mask and seal to be cleaned separately and apart
`from the headstraps.
`
`[0009] Referring again to the prior art mask seals, some
`prior art mask seals are comprised of thermoset silicone,
`closed-cell foams, molded silicone and some include a soft
`material interposed between two thin plastic films and which
`are mounted to the mask shell by different mounting tech(cid:173)
`niques. These prior art seal structures are generally known to
`be costly to manufacture.
`
`[0010] Accordingly, it is further believed that there is a
`need in the art for a new and improved mask seal which may
`be manufactured cost effectively and for a new and
`improved structure for mounting the seal to the shell.
`
`SUMMARY OF THE INVENTION
`
`[0011] A mask including a shell provided with shell
`mounting members and a seal provided with seal mounting
`members for engaging the shell mounting members to
`mount the seal to the shell, method of manufacturing a mask
`including such mask shell and seal, a mask including a
`plurality of headstraps and a headstrap retention bracket
`mounted to the headstrap for mounting the headstraps
`removably to a mask, a mask seal of generally hollow
`triangular soft resilient material including a peripheral por(cid:173)
`tion and a generally hollow triangular seal mounting mem(cid:173)
`ber embedded in the seal peripheral portion and for mount(cid:173)
`ing the seal to a mask shell, a mask shell having a
`deformable malleable member in its peripheral portion
`which may be deformed to customize the mask seal to a
`person's face and a mask with a plurality of angular vent
`holes for reducing the noise of a mask wearer's exhaled
`breath and for directing the exhaled breath away substan(cid:173)
`tially parallel to the mask wearer's body.
`
`DESCRIPTION OF THE DRAWINGS
`
`[0012] FIG. 1 is a perspective view of a mask embodying
`the present invention;
`
`[0013] FIG. 2A is an exploded view taken generally from
`the left to the right showing the elements comprising the
`mask shell and seal of the present invention;
`
`[0014] FIG. 2B is an exploded view substantially the
`reverse of FIG. 2A;
`
`Page 14
`
`

`

`US 2006/0042629 Al
`
`Mar. 2, 2006
`
`2
`
`[0015] FIG. 2C is a side view of the mask elements shown
`in FIG. 2A;
`
`[0016] FIG. 2D is a top view of the mask element shown
`in FIG. 2A;
`
`[0017] FIG. 3 is a front perspective view of the mask shell
`of the present invention;
`
`[0018] FIG. 4 is generally the reverse of FIG. 3 showing
`the interior of the mask shell;
`
`[0019] FIG. 5 is a front elevational view of the mask of the
`present invention;
`
`[0020] FIG. 6 is a cross-sectional view taken generally
`along the line 6-6 in FIG. 5 and in the direction of the
`arrows;
`
`[0021] FIG. 7 is a perspective view of the mask seal of the
`present invention;
`
`[0022] FIG. 8 is a diagrammatical illustration of the
`mounting of the mask seal to the mask shell of the present
`invention;
`
`[0023] FIG. 9 is the same as FIG. 6 but showing in detail
`the mounting of the mask seal to the mask shell of the
`present invention and further illustrating in detail the mount(cid:173)
`ing of the dual swivel members to the mask shell of the
`present invention;
`
`[0024] FIG. 10 is a perspective view taken generally from
`the bottom of the mask shell of the present invention and
`illustrating the vent holes of the present invention;
`
`[0025] FIG. 11 is an enlarged view of the encircled
`portion of FIG. 10;
`
`[0026] FIG. 12 is a front view of the mask shell of the
`present invention;
`
`[0027] FIG. 13 is a cross-sectional view taken generally
`along the line 13-13 in FIG. 12 and in the direction of the
`arrows;
`
`[0028] FIG. 13A is an enlarged view of the encircled
`portion of FIG. 13;
`
`[0029] FIG. 14 is a separate perspective view of the
`headstrap retention bracket of the present invention;
`
`[0030] FIG. 15 is a rear elevational view of the headstrap
`retention bracket of the present invention;
`
`[0031] FIG. 16 is a front elevational view of the headstrap
`retention bracket of the present invention;
`
`[0032] FIG. 17 is an illustration of the mask of the present
`invention attached by headstraps to the portions of a per(cid:173)
`son's face surrounding the nose; and
`
`[0033] FIG. 18 is an illustration of the removable mount(cid:173)
`ing of the mask shell and seal of the present invention to a
`headstrap retention bracket of the present invention and
`thereby to the headstraps of the mask of the present inven(cid:173)
`tion.
`
`DETAILED DESCRIPTION OF IBE
`INVENTION
`
`[0034] An embodiment of the mask of the present inven(cid:173)
`tion is shown in the drawings and indicated by general
`numerical designation 10. It will be understood that the
`
`mask 10 is dimensioned to be a nasal mask particularly
`useful as a nasal CPAP mask, but it will be still further
`understood that the mask of the present invention also may
`be embodied as other masks such as, for example and not by
`way of limitation, a full face mask.
`
`[0035] The mask 10, referring particularly to FIGS. 1 and
`2A-2D, includes a mask shell indicated by general numeri(cid:173)
`cal designation 12, a mask seal indicated by general numeri(cid:173)
`cal designation 14, a hollow generally triangular malleable
`member 16, a hollow generally triangular seal mounting
`member indicated by general numerical designation 18, a
`head strap retention bracket indicated by general numerical
`designation 20, and a dual swivel indicated by general
`numerical designation 22 and of the type known to the art for
`providing swiveling in two directions as indicated by the
`double headed arrows 22A and 22B in FIG. 2A. The dual
`swivel 22 includes hollow conduit swivel members 23, 24
`and 25 for being connected by a suitable gas supply hose to
`a suitable gas supply such as a ventilator or other positive
`airway pressure device (not shown) for supplying pressur(cid:173)
`ized breathing gas to a wearer of the mask 10 during
`obstructive sleep apnea treatment. The mask shell 12, FIG.
`2A, may be provided with two hollow cylindrical port
`members 26 and 27 in fluid communication with the interior
`of the shell and the mask may further include two removable
`port cap members 28 and 29 for opening and closing the port
`members 26 and 27. The port member 26 may be used, for
`example, to measure the pressure inside the mask and the
`port member 27 may be used to provide supplemental
`breathing gas, such as supplemental oxygen, to the mask and
`thereby to a wearer of the mask.
`
`[0036] The mask shell 12, referring particularly to FIGS.
`3 and 4, includes a top or an apex portion 30 and triangular
`walls 31, 32 and 33. The apex portion 30 and the triangular
`walls 31, 32 and 33 cooperatively provide the shell 12 with
`a generally triangular hollow interior 34 and the triangular
`walls 31, 32 and 33 terminate in, or provide the shell with,
`an outer shell periphery or peripheral portion indicated by
`general numerical designation 36. As may be best seen in
`FIG. 3, the shell apex portion 30 is provided with a circular
`opening 37 circumscribed by, as may be best seen in FIG.
`3, an outwardly extending hollow cylindrical wall 38 pro(cid:173)
`vided with an outwardly extending rectangular radial ridge
`39. The shell outer peripheral portion 36 is provided, as
`shown in FIGS. 3 and 4, with a plurality of outwardly
`extending solid generally cylindrical pins or connecting pins
`40.
`
`[0037] The mask shell 12 may be made from a suitable
`plastic, such as for example polyurethane, and made by
`suitable injection molding. It will be further understood that
`the hollow generally triangular malleable member 16 may
`be injection molded into the shell outer peripheral portion 36
`by suitable injection molding techniques known to the art.
`The malleable member 16 in the preferred embodiment was
`a 0.304 stainless steel wire fully annealed at finish and
`having a diameter of about 0.052 inch.
`
`[0038] The seal 14, FIGS. 2A-2D, and 7-9, may be made
`of a suitable soft resilient material sufficiently soft to con(cid:173)
`form to the contours of a person's face surrounding the mask
`wearer's nose and sufficiently resilient to return to its
`original, or at least substantially its original, shape upon
`removal from the person's face. In the preferred embodi-
`
`Page 15
`
`

`

`US 2006/0042629 Al
`
`Mar. 2, 2006
`
`3
`
`ment, the seal 12 was made of a body of material comprising
`styrene-ethylene butylene-styrene copolymer modified with
`a mineral oil. Such material may also contain antioxidants
`and Vitamin E. Such material is available from California
`Medical Innovations, 873 E. Arrow Highway, Pamona,
`California 91767 and available under the name Dermasol.
`California Medical Innovations states that such material is a
`thermoplastic elastomer which has a durometer of 15-20 on
`the Shore 00 scale. It has been found that when such material
`is injection molded it has a durometer of about 63.6 on the
`Shore 000 scale. As shown in FIGS. 2A-2D, the seal 14
`includes peripheral portions 44 and 46 with the peripheral
`portion 44 being provided with a contour to enhance sealing
`engagement with portions or contours of a person's face
`surrounding the nose and the peripheral portion 46, note
`particularly FIGS. 2A and 2C, and FIG. 7, is provided with
`a generally triangular indentation 48 complementary in
`shape to and for receiving the generally triangular shell
`peripheral portion 36 (FIGS. 3 and 4). The seal mounting
`member 18, note particularly FIGS. 2A and 2B, includes a
`hollow generally triangular frame 50 provided with a plu(cid:173)
`rality of outwardly extending bosses 52. The seal mounting
`member 18 is molded into the seal periphery or peripheral
`portion 46 using injection molding techniques known to the
`art and is thereby embedded in the seal peripheral portion 46
`as may be best understood from FIGS. 8 and 9. As will be
`further understood from FIG. 8, the mask seal 14 is mounted
`to the mask shell 12 by inserting, or forcing, the mask shell
`connecting pins 40 into the mask seal bosses 52 as indicated
`by the arrow 55 in FIG. 8. It will be understood that the shell
`connecting pins 40 and the seal bosses 52 are suitably
`dimensioned for an interference fit so as to mount the seal 14
`fixedly to the shell 12. Such mounting is illustrated in detail
`in FIG. 9. Referring again to FIG. 8, it will be understood
`that the representative embedded seal boss 52 is slightly
`recessed behind the seal indentation 48 whereby the seal
`peripheral portions 56 and 57 will compress upon the pins 40
`being inserted into the bosses 52 and act or function as a
`gasket to assure an air tight seal between the seal 14 and
`shell 12.
`[0039] As will be understood from FIG. 9, the dual swivel
`member 23 is mounted into the circular opening 37 (FIG. 4)
`formed in the apex shell portion 30 and the swivel members
`24 and 25 are thereafter suitably mounted to each other, in
`the manner known to the art, to provide the above-described
`dual swiveling indicated by the double headed arrows 22A
`and 22B in FIG. 2A.
`[0040] The mask and mask vent holes of the present
`invention are illustrated in FIGS. 10-13. The vent holes are
`exit vent holes and are for venting the exhaled breath of a
`wearer of the mask 10. As shown in FIGS. 10 and 11, the
`vent holes comprise a plurality of vent holes which are
`disposed in a curved array of vent holes including, in the
`preferred embodiment, two curved rows of vent holes; the
`plurality or curved array of vent holes are indicated by
`general numerical designation 60 in FIGS. 10 and 11, and
`the two rows of curved vent holes are indicated by numerical
`designations 61 and 62 in FIG. 11. It will be understood
`from FIG. 11 that the distance Dl between the vent holes in
`each row is equal to, or at least substantially equal to, the
`distance D2 between opposed vent holes or the vent holes in
`each curved row that are opposed to each other. The vent
`holes have a diameter, and it will be further understood from
`FIG. 11 that the distances Dl and D2 are equal to at least
`
`three times the diameter of the vent holes. In the preferred
`embodiment, the vent holes had a diameter of 0.040 inch and
`the distances Dl and D2 were 0.140 inch. It has been found
`that such vent hole diameter and vent hole spacings create a
`pattern of discrete laminar flow jets such that the flow
`exiting one vent hole does not generate turbulence in the
`flow from adjacent vent holes. This reduces the noise level
`generally associated with a person's exhaled breath exiting
`mask vent holes and such noise reduction reduces the
`annoyance to the wearer of the mask, and to a sleep partner,
`which generally arises from a patient's exhaled breath
`exiting mask vent holes known to the prior art.
`
`[0041] The angular disposition of the cylindrical vent
`holes of the present invention is illustrated in FIGS. 12-13A.
`Representative vent holes 64 and 66 are shown in FIGS. 13
`and 13A. As will be understood from FIG. 13, the out(cid:173)
`wardly extending hollow cylindrical wall 38 of the mask
`shell 12 terminates in a plane 68, and as will be further
`understood from FIG. 13 the vent holes, note representative
`vent hole 64, are disposed at an acute exit angle A with
`respect to the plane 68; in the preferred embodiment the
`angle A was 30°. As will be further understood from FIG.
`13A, the wall 33 in which the vent holes are formed has a
`thickness T and the vent holes have a diameter D which is
`less than the thickness T. In the preferred embodiment, the
`mask wall 33 had a thickness of 0.050 inch and the vent
`holes had a diameter D of 0.040 inch. It has been found that
`such angular disposition of the vent holes in the mask shell
`wall 33 causes the patient's exhaled breath to exit in a flow
`stream which is substantially parallel to the body of the
`wearer of the mask 10. This permits the person's exhaled
`breath to escape the mask without causing discomfort to the
`wearer of the mask or to a sleep partner onto which the
`escaped exhaled breath may be flowing or escaping.
`
`[0042] The removable mounting of the mask seal 14 and
`shell 12 of the mask 10 of the present invention to the
`headstraps for fastening the mask to a wearer's face is
`provided, in part, by the headstrap retention bracket 20
`shown in separate detail in FIGS. 14-16. The headstrap
`retention bracket 20 is provided with a generally semi(cid:173)
`circular indentation 72, FIG. 15, which is provided gener(cid:173)
`ally centrally with an outwardly extending rectangular
`indentation 73. The indentations 72 and 73, FIGS. 14 and
`16, are circumscribed by an outwardly extending generally
`semi-circular wall or member 74 including a radially out(cid:173)
`wardly extending portion providing a radially inwardly
`extending recess 73A. The wall 74 is complementary in
`shape to and for receiving portions of the shell hollow
`cylindrical wall 38 in a wedged or friction engagement with
`the radial ridge being received in the radial recess 73A. The
`headstrap retention member 20, FIGS. 14-16, is provided
`with three openings 75, 76 and 77 for respectively receiving
`headstraps 78, 79 and 80 as shown in FIGS. 17 and 18.
`
`[0043] The mask 10 of the present invention may include
`such headstraps and is illustrated as being attached to a
`person's face in FIG. 17 as a nasal CPAP mask for the
`treatment of obstructive sleep apnea treatment. A corrugated
`gas supply hose 90 is attached to the dual swivel hollow
`conduit member 26 (FIG. 1) and is inserted through a
`headstrap member 92, FIG. 17, and is further connected to
`a ventilator (not shown), in the manner known to the art, for
`supplying pressurized breathing gas to a person for the
`above-noted night time sleep apnea treatment.
`
`Page 16
`
`

`

`US 2006/0042629 Al
`
`Mar. 2, 2006
`
`4
`
`[0044] The removable mounting of the mask shell 12 and
`seal 14 to the headstraps 78-80 is illustrated diagrammati(cid:173)
`cally in FIG. 18. The headstraps are inserted through the
`loops or holes formed in the headstrap retention bracket 20,
`as illustrated diagrammatically in FIG. 18, and the headstrap
`retention bracket 20, as indicated by the downwardly
`extending arrow 94 in FIG. 18 is forced downwardly, with
`manual force applied by the person to wear the mask, to
`force the generally semi-circular wall 74 of the headstrap
`retention bracket 20 into wedged or interference friction
`engagement with the portions of hollow cylindrical wall 38
`provided on the mask shell 12 and with the mask shell
`outwardly extending rectangular radial ridge 39 being
`received within the inwardly extending rectangular recess 73
`formed in the wall 74 of the head retention bracket 20. The
`receipt of the ridge 39 in the recess 73A orients the head
`retention bracket 20 to the shell 12 and seal 14 and thereby
`orients the headstraps to the mask shell and seal. Also, this
`mounts the mask shell 12 and seal 14 removably to the
`headstrap retention bracket 20, and thereby removably to the
`headstraps 78-80, which permits the mask shell 12 and seal
`to be removed from the headstrap retention bracket, and
`thereby from the headstraps, with the use of manual force
`from the mask wearer.
`
`[0045] Upon the mask shell 12 and seal 14 being mounted
`to the headstrap retention bracket 20 and the headstraps
`78-80, the headstraps may be placed over and around
`portions of the person's head as shown in FIG. 17 and
`manual force from the mask wearer is used to apply tension
`to the adjustable headstrap members, as indicated by the
`arrows in FIG. 17, to adjust the tension supplied to the mask
`and to adjust the amount of force with which the mask seal
`14 is forced into air tight sealing engagement with the
`portions of the mask wearer's face surrounding the nose.
`The malleable member 16, embedded in the outer peripheral
`portion of the mask shell 12, particularly FIGS. 8 and 9,
`may be deformed to further individualize or customize the
`fitting of the mask seal 14 to the portions or contours of the
`mask wearer's face surrounding the nose.
`
`[0046] Should, for example, the mask wearer undergoing
`the noted obstructive sleep apnea treatment need to get up
`and move about, such as to go to the bathroom, the previ(cid:173)
`ously adjusted headstraps need not be removed from the
`person's face but instead, the previously adjusted headstraps
`may remain adjusted and fastened to the person's head, and
`the mask shell 12 and seal 14 may be removed from the
`headstrap retention bracket while the headstraps remain
`attached to the person's head. Such removal is accomplished
`by the use of manual force from the mask wearer with the
`mask shell 12 and seal 14 being pulled downwardly, oppo(cid:173)
`site the direction of the arrow 94 in FIG. 18, to disengage
`or unwedge the mask shell cylindrical wall 38 from the
`semi-cylindrical wall 74 of the headstrap retention bracket
`20. The gas supply hose 90, FIG. 19, is then removed from
`the heads trap member 92 and the person is now free from the
`mask shell 12, seal 14 and the gas supply hose 90. The
`person may move about freely while the headstraps remain
`previously individualized and attached to the person's head.
`Upon the person returning to resume the sleep apnea treat(cid:173)
`ment, the mask shell 12 and seal 14 are again mounted to the
`headstrap retention bracket 20 as described above and
`illustrated in FIG. 18.
`
`It will be understood by those skilled in the art that
`[0047]
`many variations and modifications may be made in the
`present invention without departing from the spirit and the
`scope thereof.
`
`What is claimed is:
`1. Mask, comprising:
`
`a generally triangular shell including an apex portion and
`triangular walls providing an interior and including a
`shell outer peripheral portion, said apex portion pro(cid:173)
`vided with a circular opening circumscribed by an
`outwardly extending hollow cylindrical member termi(cid:173)
`nating in a plane and for supplying gas to said mask,
`said shell outer peripheral portion provided with first
`mounting means;
`
`a seal including a seal outer peripheral portion provided
`with second mounting means for engaging said first
`mounting means to mount said seal to said shell;
`
`one of said walls for being disposed beneath a person's
`nose and wherein said one wall is provided with a
`plurality of vent holes extending upwardly from said
`interior and angularly outwardly through said one wall;
`
`a malleable member mounted in said shell outer periph(cid:173)
`eral portion and for being deformed to deform said
`shell and thereby said seal to fit said seal to portions of
`a person's face;
`
`a plurality of adjustable headstraps for surrounding and
`being attached to a person's head; and
`
`a headstrap retention bracket mounted to said plurality of
`headstraps and provided with a generally inwardly
`extending indentation generally complementary in
`shape to said cylindrical member and for permitting
`said headstrap retention bracket to wedgedly engage
`said cylindrical member to mount said shell and said
`seal removably to said plurality of headstraps.
`2. The mask according to claim 1 wherein said first
`mounting means comprise a plurality of pins extending
`outwardly from said shell outer peripheral portion and
`wherein said second mounting means comprise a plurality of
`bosses extending outwardly to said seal outer peripheral
`portion and for wedgedly receiving said pins.
`3. The mask according to claim 1 wherein said seal
`comprises a generally hollow triangular body comprising a
`styrene-ethylene butylene-styrene copolymer modified with
`a mineral oil.
`4. The mask according to claim 1 wherein said seal
`comprises a generally hollow triangular body comprising a
`styrene-ethylene butylene-styrene copolymer modified with
`a mineral oil having a durometer of about 63.6 on the Shore
`000 scale.
`5. The mask according to claim 1 wherein said seal
`comprises a body of moldable material and wherein said
`second mounting means is molded into said moldable mate(cid:173)
`rial.
`6. The mask according to claim 5 wherein said moldable
`material comprises a styrene-ethylene butylene-styrene
`copolymer modified with a mineral oil.
`7. The mask according to claim 1 wherein said shell
`comprises a body of first moldable material, wherein said
`first mounting means comprise a plurality of pins extending
`outwardly from said shell outer peripheral portion, and
`wherein said seal comprises a body of second moldable
`
`Page 17
`
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`US 2006/0042629 Al
`
`Mar. 2, 2006
`
`5
`
`material and wherein said second mounting means comprise
`a plurality of outwardly extending bosses for wedgedly
`receiving said pins.
`8. The mask according to claim 7 wherein said second
`mounting means comprise a hollow generally triangular
`frame molded into said seal outer peripheral portion and
`provided with said plurality of bosses.
`9. The mask according to claim 1 wherein said mask
`comprises a body of moldable material and wherein said
`malleable member is molded into said shell outer peripheral
`portion.
`10. The mask according to claim 1 wherein said plurality
`of vent holes are disposed at an exit angle of approximately
`30° with respect to said plane.
`11. The mask according to claim 1 wherein said one wall
`has a thickness and wherein said vent holes are cylindrical
`and have a diameter less than said thickness of said one wall.
`12. The mask according to claim 1 wherein said hollow
`cylindrical member is provided with an outwardly extending
`radial ridge, wherein said indentation is a generally semi(cid:173)
`circular indentation provided with a generally central
`inwardly extending radial indentation, wherein said inden(cid:173)
`tations are circumscribed by an outwardly extending gener(cid:173)
`ally semi-cylindrical member including an inwardly extend(cid:173)
`ing portion providing a radial recess and wherein said
`generally semi-cylindrical member is for wedgedly engag(cid:173)
`ing said cylindrical member with said radial recess receiving
`said radial ridge to orient said retention bracket with respect
`to said shell and to mount said shell and said seal removably
`to said plurality of headstraps.
`13. The mask according to claim 1 wherein said seal outer
`peripheral portion is provided with a seal indentation
`complementary to and for receiving said shell outer periph(cid:173)
`eral portion to facilitate mounting of said seal to said shell.
`14. The method of manufacturing a mask, comprising the
`steps of:
`
`molding a seal having first mounting means molded
`therein; and
`
`providing a shell having second mounting means, and
`mounting said seal to said shell by engaging said first
`mo