`
`
`
`1111111111111101111110101111111141!11111811111,!111111111111011011110111111
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0025882 Al
`Feb. 12, 2004
`Madaus et al.
`(43) Pub. Date:
`
`(54) HOLDING DEVICE FOR A RESPIRATORY
`MASK
`
`(76)
`
`Inventors: Stefan Madaus, Krailling (DE);
`Harald Vogele, Gauting (DE)
`
`Publication Classification
`
`(51) Int. C1.7
`(52) U.S. Cl.
`
` A62B 18/08; A62B 9/06
` 128/206.27; 128/207.11; 128/207.17
`
`Correspondence Address:
`PILLSBURY WINTHROP, LLP
`P.O. BOX 10500
`MCLEAN, VA 22102 (US)
`
`(21)
`
`Appl. No.:
`
`10/333,020
`
`(22)
`
`PCT Filed:
`
`Jun. 22, 2001
`
`(86)
`
`PCT No.:
`
`PCT/EP01/07132
`
`(30)
`
`Foreign Application Priority Data
`
`Jul. 21, 2000
`
`(DE)
`
` 100 35 946.9
`
`2O
`
`(57)
`
`ABSTRACT
`
`A holding device for a respiratory mask, especially for use
`in the field of sleep medicine, includes a headband which, in
`an application position, extends from the forehead area of
`the patient to behind the ear area of the patient, whereby the
`headband is provided with a flexible reinforcing insert for
`reinforcing the headband in a lateral direction. This makes it
`advantageously possible to provide the mask retention
`forces, which are necessary for reliably applying a respira-
`tory mask, in a manner that is very compatible with regard
`to ergonomics.
`
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`EXHIBIT 1018 - PAGE 1
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`Patent Application Publication Feb. 12, 2004 Sheet 1 of 6
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`US 2004/0025882 Al
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`1
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`Fig. 1
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`EXHIBIT 1018 - PAGE 2
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`Patent Application Publication Feb. 12, 2004 Sheet 2 of 6
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`US 2004/0025882 Al
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`Fig. 2
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`Fig. 3
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`Fig. 4
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`2
`6
`g
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`10
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`Fig. 5
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`10
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`Fig. 6
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`EXHIBIT 1018 - PAGE 3
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`Patent Application Publication Feb. 12, 2004 Sheet 3 of 6
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`US 2004/0025882 Al
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`'2..0
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`Fig. 7
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`'1-
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`EXHIBIT 1018 - PAGE 4
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`Patent Application Publication Feb. 12, 2004 Sheet 4 of 6
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`US 2004/0025882 Al
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`Fig. 8
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`1.2
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`ZZ.
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`21 a.
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`Fig. 9
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`Patent Application Publication Feb. 12, 2004 Sheet 5 of 6
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`US 2004/0025882 Al
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`c•%--
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`L.
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`EXHIBIT 1018 - PAGE 6
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`Patent Application Publication Feb. 12, 2004 Sheet 6 of 6
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`US 2004/0025882 Al
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`Z
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`Fig. 11
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`US 2004/0025882 Al
`
`Feb. 12, 2004
`
`1
`
`HOLDING DEVICE FOR A RESPIRATORY MASK
`
`[0001] The present invention refers to a holding device for
`a respiratory mask, as it may for instance be used in the field
`of sleep medicine for fixing a nasal mask to the face of a
`patient.
`
`[0002] Known holding devices of the above-mentioned
`kind usually comprise an upper belt arrangement and a
`lower belt arrangement, which are joined through a web
`arrangement arranged in the application position of the
`holding device at the back head portion of the patient. The
`two belt arrangements are made of a flexible textile material.
`In the area of the free end portions of the upper and lower
`belt arrangement, Velcro fastener means are provided
`through which the effective length and thus the press-on
`pressure of the respiratory mask against the face of the
`patient can be adjusted depending on the respective need.
`The upper belt arrangement may be connected in certain
`mask types with a forehead holding device so that the
`press-on pressure of the forehead rest element against the
`forehead of the patient can be defined by adjusting the
`effective length of the upper belt arrangement.
`
`[0003] Depending on required therapeutic pressure of the
`respiratory gas supplied via the respiratory mask and
`depending on the individual face structure of the patient,
`mask press-on forces are partially required, which leave
`visible marks after a longer application of the mask on the
`face of the patient or in the forehead area.
`
`[0004] The invention is based on the object to provide a
`manageable holding device for a respiratory mask through
`which a desired respiratory mask press-on force by obtain-
`ing an improved wearing comfort can be exerted in a reliable
`manner.
`
`[0005] This object is solved according to the invention by
`a holding device for a respiratory mask by the features
`defined in claim 1.
`
`[0006] Thereby it becomes possible in an advantageous
`manner to fix the respiratory mask at low tension forces on
`the face of the patient. For the case that e.g. due to an
`increased internal mask pressure, the mask tends to lift off
`the patient's face, a correspondingly greater mask fixing
`force is automatically exerted.
`
`[0007] An extremely reliable fixing of the forehead rest
`element in the forehead portion of the patient is achieved in
`an advantageous manner without significant tensile forces
`being exerted on the belt arrangement extending across the
`forehead and the back of the head.
`
`[0008] An embodiment that is especially advantageous in
`view of an especially high wearing comfort is given in that
`the upper belt arrangement is formed with a waist in a
`manner that it extends from the forehead portion to the
`respective ear portion of the patient, and then takes a course
`diverging in the area of the ears towards the parting, and
`directly behind the ears descends and encompasses the back
`head portion of the patient in the area of the neck or
`approximately on the level of the patient's nose.
`
`[0009] The flexible insert provided in the holding device
`may for instance be made of a thermoplastic plastic material
`layer having a thickness of 0.8 to 1.5 mm. A pad support is
`arranged in an area provided between the tensile-rigid inset
`and the patient. This pad support is according to an espe-
`
`cially preferred embodiment of the invention formed by a
`thin and locally stitched foam layer on whose outer side a
`web material is backed. This web material may be a textile
`material or for instance a washable material to be wet-
`cleaned.
`
`[0010] The headband arrangement of the respiratory mask
`is preferably provided with an adjustment means through
`which the effective length of the headband can be adjusted
`variably. The adjustment means may also be formed by a
`lock/clamping shift mechanism and/or by a Velcro fastener
`means.
`
`[0011] According to an especially preferred embodiment
`of the invention, the flexible layer is formed of a plastic
`material, e.g. of a thermoplastic plastic material. As an
`alternative hereto or in combination therewith, it is also
`possible to make the flexible layer of a metal material, e.g.
`of a thin spring steel sheet. The bending elasticity of the
`flexible layer may be affected in a defined way by punchings
`or deep drawing structures. The flexible layer is, according
`to an especially preferred embodiment of the invention,
`punched out of a corresponding web material by means of a
`punching process. As an alternative, it is also possible to
`make the flexible layer by means of a plastic shaping
`process, e.g. of a thermoplastic material in an injection tool.
`It is also possible to provide especially reinforcing or
`functional structures on the mask holding device.
`
`[0012] According to an especially preferred embodiment
`of the invention, the flexible layer is made of a thermo-
`formable material. Thereby it becomes possible in an advan-
`tageous manner to adapt the headband heated to a tempera-
`ture of 60° C. individually to the patient, wherein the
`headband after cooling to ambient temperature may keep an
`advantageous spatial shape in view of a possible low surface
`pressure.
`
`[0013] An embodiment that is especially advantageous in
`view of an especially high wearing comfort is provided in
`that the headband section is provided with a padding means.
`The padding means may preferably be formed of an open-
`cell foamed foam material. The padding means is preferably
`provided with a textile or washable layer. By the formation
`of locally stitched sections, the padding behavior of the
`padding means may be adapted in an advantageous manner.
`
`[0014] An embodiment of the invention that is especially
`advantageous in view of an especially reliable fixing of the
`respiratory mask on the headband is given in that the holding
`device is provided—at least section-wise—with one of the
`two complementary structures of a Velcro fastening means.
`For this purpose, the headband is formed in a multi-layered
`backed manner. Thus, the flexible layer possibly provided
`with breakthroughs may for instance form the core portion
`of the headband, wherein a padding and a cover layer chosen
`with respect to structure and color are backed on the side
`facing the head of the patient in the application position of
`the headband.
`
`[0015] An embodiment that is advantageous in view of an
`especially high wearing comfort is given in that the head-
`band section has, seen in application position, an extension
`directed from the forehead portion to the upper ear portion,
`and an extension locally drawn up in the ear portion,
`wherein the headband portion directly after the ear portion
`has an extension descending towards the back of the head.
`
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`EXHIBIT 1018 - PAGE 8
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`US 2004/0025882 Al
`
`Feb. 12, 2004
`
`2
`
`[0016] The above-mentioned object is solved according to
`a further solution idea by a holding device for a respiratory
`mask, having an element of increased flexural strength
`extending from the forehead portion laterally to the upper
`ear portion, and a bracket section descending behind the ear
`towards the neck, and a means for supporting the bracket
`section in the back head portion.
`
`[0017] Thus, it becomes possible in an advantageous
`manner to apply a respiratory mask in a comfortable manner
`and possibly to refrain from using a belt arrangement.
`
`[0018] The element of increased flexural strength may for
`instance be made of a wire material, in particular of a spring
`steel material. In an advantageous manner the element of
`increased flexural strength has a section projecting towards
`the nose tip of the patient that urges the respiratory mask
`against the face of the patient.
`
`[0019] The introduction of forces into the respiratory mask
`is preferably implemented in that a deformation axis extends
`through a point of gravity of the mask support surface.
`
`[0020] The support on the back of the head is preferably
`implemented by a padded band element in a manner that a
`deformation axis is defined which basically corresponds to
`the deformation axis acting on the mask.
`
`[0021] Further details can be derived from the following
`description in connection with the drawing.
`
`[0022] FIG. 1 shows a simplified view to explain the
`application position of a holding device for a respiratory
`mask according to a first preferred embodiment of the
`invention;
`
`[0023] FIG. 2 shows a simplified sectional view to explain
`a preferred internal structure of a holding device for a
`respiratory mask with a flexible inset that is has lateral
`flexural strength;
`
`[0024] FIG. 3 shows a further, simplified sectional view to
`explain the inner structure of a further preferred embodiment
`of the holding device for a respiratory mask, also having a
`flexible insert;
`
`[0025] FIG. 4 shows a simplified sectional view through
`a holding device for a respiratory mask according to a fourth
`preferred embodiment having a padded circumferential edge
`stitched by a stitching seam;
`
`[0026] FIG. 5 shows a perspective view of a section of a
`holding device for a respiratory mask with a flexible inset
`that has flexural strength in the lateral direction and that has
`an integrated padding means;
`
`[0027] FIG. 6 shows a simplified detail sectional view to
`explain the stitching points formed by a melt-welding pro-
`cess on the inner side of the headband of the holding device;
`
`[0028] FIG. 7 shows a perspective view of a further
`embodiment of a holding device for a respiratory mask, in
`this case with a bracket element for exerting a respiratory
`mask press-on force;
`
`[0029] FIG. 8 shows a simplified perspective view of a
`further embodiment of a holding device for a respiratory
`mask having a reinforcement insert;
`
`[0030] FIG. 9 shows a simplified view of the holding
`device, however basically with integrated forehead rest
`attachment flaps according to FIG. 8 in application position;
`
`[0031] FIG. 10 shows a simplified view to explain a
`further embodiment of a holding device of a respiratory
`mask with a flexible reinforcement insert and an opening
`shown in this Figure in application position in the back head
`portion;
`
`[0032] FIG. 11 is a principle sketch to explain the flexural
`strength of the flexible insert around their main axes.
`
`[0033] FIG. 1 shows a first preferred embodiment of a
`holding device for a respiratory mask, which comprises a
`headband section 1, which is laterally reinforced by a layer
`flexible in the winding direction. The headband section 1
`extends in the application position from the forehead portion
`of the patient around the back head portion of the patient. To
`adapt the effective length of the headband section 1 to the
`individual head circumference of the patient, an adjustment
`means 2 is provided, which in the embodiment shown is
`formed by a Velcro fastener means. The outer portion of the
`headband section 1 visible in this case is formed by a fleece
`material, which can be brought into an adhesive connection
`with corresponding complementary Velcro fastener struc-
`tures. Thus, it becomes possible, in particular in the area
`indicated by the dotted lines 3 to fix a forehead rest element
`of a respiratory mask. It is possible by the flexible layer
`integrated into the headband to give the headband an arbi-
`trary extension in the lateral direction. In the embodiment
`shown in this case, the headband extends from the front
`forehead portion towards the upper ear portion and above
`the ear it has an extension diverging towards the top. In its
`further extension towards the back head portion, the head-
`band descends towards the neck.
`
`[0034] FIG. 2 shows a simplified sectional view through
`a section of the headband 1.
`
`[0035] The headband 1 has a reinforcement layer 4 which
`is formed in this case of a thermoplastic material, the
`thickness of the reinforcement insert being in this case 0.75
`mm. On the side of the reinforcement insert 5 facing the
`patient in the application position, a padding 5 is provided,
`which in this case is formed of an open-cell foamed foam
`material. The padding 5 in turn is covered by a cover layer
`6 which is formed in this case by a textile material. The
`cover layer 6 and the padding 5 are coupled via a connection
`point 7 with the flexible layer. The connection point 7 is in
`this case formed by a stitching seam.
`
`[0036] The padding 5 and a section of the cover layer are
`guided around a lateral edge of the reinforcement layer 4.
`This leads to an especially advantageous padding of the
`lateral edge of the reinforcement insert 4. The section guided
`around the reinforcement insert 4 is sewed onto the rein-
`forcement insert 4 by means of said stitching seam. The
`stitching seam extends in the embodiment shown through a
`fleece material 8, which points towards the outside in the
`application position of the headband. The fleece material 8
`is additionally directly adhered onto the reinforcement insert
`4.
`
`[0037] FIG. 3 shows a further embodiment of the head-
`band. Here, the padding body 5 is backed onto the rein-
`forcement insert during a flame backing process. A fleece
`material layer 8 is provided on the rear side of the rein-
`forcement insert 4 similar to the embodiment according to
`FIG. 2. The fleece material layer 8 is formed with respect to
`its layer thickness in a manner that a sufficient padding effect
`
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`EXHIBIT 1018 - PAGE 9
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`US 2004/0025882 Al
`
`Feb. 12, 2004
`
`3
`
`is achieved also towards the outside due to the fleece
`material layer 8. If needed, a padding may also be provided
`between the fleece material layer 8 and the reinforcement
`insert 4. In the embodiment shown in FIG. 3, the lateral
`edges of the reinforcement insert 4 are also lined by the
`material of a cover layer, which is guided around the lateral
`edges of the reinforcement insert and which is fixed by
`stitching seams.
`
`[0038] The embodiment of the headband shown in FIG. 4
`also comprises a reinforcement insert 4 and a fleece material
`layer 8 provided on the outwardly pointing side of the
`headband, said fleece material layer being guided around the
`lateral edge portion of the reinforcement insert 4 and which
`is fixed on the sides of the padding 5 together with a cover
`layer 6. The fixing is made preferably by stitching seams 9
`that are shown in a highly magnified manner.
`
`[0039] FIG. 5 shows in a partially broken-up view a
`section of a headband according to the invention. The
`headband shown in this Figure again comprises a flexible
`reinforcement insert 4, which reinforces the headband
`against a bending around an axis perpendicularly to the
`headband rest surface. The flexible layer 4 is embedded
`between the rear cover layer, which is formed e.g. by the
`fleece material 8, and the inner cover layer 6 by interposition
`of the padding body 5. Stitching points 10 can be formed
`preferably by a thermo-welding process on the inner side of
`the headband, said stitching points providing the padding
`with a certain pre-load. The stitching points can for instance
`be formed during an ultrasonic welding process or by a
`correspondingly heated punching tool. An embodiment of
`the headband that is especially inexpensive to manufacture
`is provided in that the two layers 6, 8, and possibly also the
`reinforcement insert 4, are also connected to one another by
`an adhesion process.
`
`[0040] A preferred embodiment of the stitching sections is
`shown in FIG. 6. As can be recognized, the cover layer 6 is
`welded onto the reinforcement layer 4 in the area of the
`welding points 10 through the hot-molten material of the
`padding 5.
`
`[0041] FIG. 7 shows a further preferred embodiment of a
`holding device for a respiratory mask, which in this Figure
`comprises a headband 12, which is preferably in the same
`manner as the above-described headband 1 provided with an
`integral reinforcement layer. The headband 12 is provided
`with an element 14 having flexural strength, which extends
`in the application position of the holding device in a bracket-
`like descending manner behind the ear of the patient towards
`the neck portion. The element 14 having flexural strength
`may be supported via a support means 15 at the back head
`or neck portion of the patient. In the embodiment of the
`invention shown, the support means is formed by a band
`element 15 that is longitudinally adjustable, which is
`coupled below the ear portion of the patient with the element
`14 having flexural strength. A mask fixing means 16 is
`provided on the element 14 having flexural strength, said
`mask fixing means extending from the forehead portion to
`the nose tip of the patient. The mask fixing means 16 is
`coupled with a respiratory mask 17 in a section which
`basically extends in the area of the point of gravity that
`extends through the sealing pad of the facial rest zone
`defined by the respiratory mask. In the embodiment shown,
`the coupling of the respiratory mask 17 with the mask fixing
`
`means 16 is implemented in that the respiratory mask can be
`tilted to a certain extent. The arrangement is preferably
`adapted so that the deformation axis of the press-on force
`acting on the respiratory mask 17 substantially corresponds
`to the deformation axis caused by the support means 15a and
`the headband 12 themselves.
`
`[0042] The element 14 having flexural strength is prefer-
`ably releasably fixed to the headband 12 via a Velcro
`fastener means.
`
`[0043] The mask fixing means 16 and the element 14
`having flexural strength are made of a steel spring wire in the
`embodiment shown in this case.
`
`[0044] The headband 12 further comprises quick acting
`closure means 20 through which the headband 12 can be
`expanded and shortened in a defined manner. In the embodi-
`ment shown it is possible to attach a further band element
`(only indicated by way of a hint) to the element 14 having
`flexural strength, by means of which said band element
`additional holding forces can be exerted in the fashion of a
`belt arrangement onto the respiratory mask 17.
`
`[0045] FIG. 8 shows a further embodiment of a holding
`device for a respiratory mask, which in turn comprises a
`headband 1, which is provided in the application surface
`with a substantially lateral reinforcement insert 4 which is of
`flexural strength and can be unwound in the circumferential
`direction. The headband 1 comprises in the application
`position behind the ear portion of the patient descending
`sections subsequently extending around the neck portion. An
`elastic band 22 is provided to fix the headband 1, said band
`extending around the back head portion of the patient. On
`the section of the headband 1 resting in the application
`position on the forehead of the patient, a forehead rest
`element of a respiratory mask arrangement may be fixed via
`a Velcro fastener means. Further forces may be exerted onto
`the respiratory mask via further lower belts 22.
`
`[0046] FIG. 9 shows as an example a holding means for
`a respiratory mask in the application position, the structure
`thereof basically corresponding to the holding device shown
`in FIG. 8. The holding device 1 extends from the forehead
`portion of the patient towards its upper ear portion and
`directly descends behind the ears of the patient towards the
`patient's neck. A respiratory mask (not shown in detail) may
`additionally be fixed via the lower belt arrangement. By
`fixing the respiratory mask via the forehead rest element and
`the lower belt arrangement, an application of the respiratory
`mask advantageous in terms of ergonomics is obtained. The
`forehead support element of the respiratory mask (not
`shown) may be implemented via a Velcro fastener 23 shown
`in a simplified manner.
`
`Instead of the elastic tension 22 provided in the
`[0047]
`embodiment according to FIG. 8, it is also possible to design
`the holding device 1 in a manner that this holding device
`defines in the back head portion of the patient a larger
`opening and is supported via at least two back head sections
`23, 24 in the back head portion of the patient. The back head
`sections 23, 24 are preferably, as shown, adjustable in
`length.
`
`[0048] FIG. 11 shows a basic sketch to explain the
`mechanical properties of the flexible reinforcement insert 4.
`The flexible reinforcement insert allows a bending strain
`around the main axes x and y extending in the main level e
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`EXHIBIT 1018 - PAGE 10
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`US 2004/0025882 Al
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`Feb. 12, 2004
`
`4
`
`of the reinforcement insert 4. Deformations and reinforce-
`ment insert 4 around the main axis z extending perpendicu-
`larly to the level e are substantially avoided due to the large
`width of the reinforcement insert. The width B of the
`reinforcement insert 4 and the thickness t of the reinforce-
`ment insert 4 and the E-module E of the reinforcement insert
`4 are preferably adapted such that the bending momentum
`around the main axis Z occurring during the application of
`the respiratory mask does not cause indadmissibly great
`deformations.
`
`[0049] Since the flexural strength of the reinforcement
`layer 4 around the main axis Z is substantially defined by the
`edge zone portion rl, r2 of the reinforcement insert 4, it is
`possible to provide openings in the intermediate portion, so
`that the reinforcement insert 4 has a substantially lattice-
`work-like structure.
`
`[0050] A latticework-like structure of the reinforcement
`insert 4 may in particular be realized in the manufacture of
`the reinforcement insert 4 by a plastic injection tool.
`
`In zones of an especially high bending load it is
`[0051]
`also possible to provide a plurality of reinforcement inserts
`in the headband, or to form the reinforcement layers with
`locally thicker portions.
`
`1. A holding device for a respiratory mask comprising a
`headband section, which in application position extends
`from the forehead portion of the patient up to the back head
`portion of the patient located behind the ears, wherein the
`headband has at least a flexible layer which substantially has
`flexural strength for reinforcing the headband section in the
`lateral direction.
`2. A holding device as claimed in claim 1, characterized
`in that the flexible layer is made of a flat plastic material.
`3. A holding device as claimed in claim 1, characterized
`in that the flexible layer is made of a sheet strip.
`4. A holding device as claimed in claim 1 or 2, charac-
`terized in that the flexible layer is made of a thermo-
`formable material.
`5. A holding device as claimed in one of claims 1 to 4,
`characterized in that the headband section is provided with
`a padding means.
`6. A holding device as claimed in one of claims 1 to 5,
`characterized in that the headband section is provided with
`a Velcro fastener fleece material.
`
`7. A holding device as claimed in at least one of claims 1
`to 6, characterized in that the headband is formed in a
`multi-layered backed manner.
`8. A holding device as claimed in at least one of claims 1
`to 7, characterized in that the flexible layer is provided with
`breakthroughs.
`9. A holding device as claimed in at least one of claims 1
`to 8, characterized in that the headband section has an
`extension in the application direction directed from the
`forehead portion of the patient towards the upper ear portion
`and that it has a locally drawn-up extension descending in
`the back head portion.
`10. A holding device as claimed in at least one of claims
`1 to 9, characterized in that the padding of the headband is
`formed by a foam layer, which is located in the application
`position of the headband between the flexible reinforcement
`inset and the patient.
`11. A holding device for a breathing mask as claimed in
`claim 10, characterized in that the padding comprises
`stitched sections.
`12. A holding device for a respiratory mask as claimed in
`claim 10 or 11, characterized in that the stitched sections are
`formed by a thermal welding process.
`13. A holding device for a respiratory mask having an
`element of increased flexural strength extending from the
`forehead portion laterally to the ear portion, having bracket
`sections descending behind the respective ear portion
`towards the neck, and having a means for supporting the two
`bracket sections in the back head portion.
`14. A holding device for a respiratory mask as claimed in
`claim 13, characterized in that the element of increased
`flexural strength has a section projecting towards the nose
`tip of the patient, which urges the respiratory mask against
`the face of the patient.
`15. A holding device as claimed in claim 13 or 14,
`characterized in that the introduction of forces into the
`respiratory mask is performed in a manner that a deforma-
`tion axis extends through a point of gravity which extends
`through the pressure distribution of the mask rest surface.
`16. A holding device for a respiratory mask as claimed in
`at least one of claims 13 to 15, characterized in that the
`support on the back of the head defines a deformation axis
`that corresponds to the deformation axis acting on the mask.
`
`*
`
`*
`
`*
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`*
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`*
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`EXHIBIT 1018 - PAGE 11
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