U.S. patent application number 13/616036 was filed with the patent office on 2013-01-03 for holding device for a respiratory mask.
This patent application is currently assigned to MAP Medizin Technologie GmbH. Invention is credited to Stefan Rolf MADAUS, Harald VOGELE.
Application Number | 20130000648 13/616036 |
Document ID | / |
Family ID | 7649989 |
Filed Date | 2013-01-03 |
United States Patent
Application |
20130000648 |
Kind Code |
A1 |
MADAUS; Stefan Rolf ; et
al. |
January 3, 2013 |
HOLDING DEVICE FOR A RESPIRATORY MASK
Abstract
A holding arrangement for a respiratory mask includes a strap
portion having at least a portion providing a multi-layered
construction including a rigid or semi-rigid material enclosed by a
softer, patient contacting material. The rigid or semi-rigid
material includes a flat plastic layer and the softer, patient
contacting material includes a fabric layer provided between the
flat plastic layer and the patient's skin and adapted to contact
the patient's skin. Lateral edges of the multi-layered construction
are fixed by stitching.
Inventors: |
MADAUS; Stefan Rolf;
(Krailling, DE) ; VOGELE; Harald; (Gauting,
DE) |
Assignee: |
MAP Medizin Technologie
GmbH
Martinsried
DE
|
Family ID: |
7649989 |
Appl. No.: |
13/616036 |
Filed: |
September 14, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11529296 |
Sep 29, 2006 |
8286634 |
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13616036 |
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10333020 |
Jun 2, 2003 |
7562658 |
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PCT/EP01/07132 |
Jun 22, 2001 |
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11529296 |
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Current U.S.
Class: |
128/207.13 |
Current CPC
Class: |
A61M 16/0633 20140204;
A61M 16/0616 20140204; A61M 16/0688 20140204; A61M 16/0683
20130101; A61M 16/06 20130101; A42B 1/00 20130101 |
Class at
Publication: |
128/207.13 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 21, 2000 |
DE |
DE 100 35 946.9 |
Claims
1-16. (canceled)
17. A holding arrangement for a respiratory mask, comprising: a
strap portion having at least a portion providing a multi-layered
construction including a rigid or semi-rigid material enclosed by a
softer, patient contacting material, the rigid or semi-rigid
material including a flat plastic layer and the softer, patient
contacting material including a fabric layer provided between the
flat plastic layer and the patient's skin and adapted to contact
the patient's skin, wherein lateral edges of the multi-layered
construction are fixed by stitching.
18. A holding arrangement according to claim 17, wherein the fabric
layer includes a textile material layer provided on one side of the
flat plastic layer and adapted to contact the patient's skin.
19. A holding arrangement according to claim 18, wherein the
softer, patient contacting material includes a fleece material
layer provided on the opposite side of the flat plastic layer and
adapted to face away from the patient's skin.
20. A holding arrangement according to claim 17, wherein the strap
portion includes an upper strap adapted to pass along the patient's
forehead, a lower strap adapted to pass along the patient's cheek,
and a rear strap adapted to descend behind the ears of the patient
towards the patient's neck.
21. A holding arrangement according to claim 20, wherein the strap
portion includes upper and lower back straps adapted to cup and/or
rest on the patient's occiput.
22. A holding arrangement according to claim 17, wherein the strap
portion includes a fastening portion.
23. A holding arrangement according to claim 22, wherein the
fastening portion includes hook and loop fasteners.
24. A respiratory mask arrangement, comprising: a respiratory mask;
and the holding arrangement according to claim 17.
25. A respiratory mask arrangement according to claim 24, wherein
the mask includes a frame and a nasal seal provided to the frame.
Description
[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 obtaining 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 especially 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 advantageous manner to
adapt the headband heated to a temperature of 60.degree. 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 headband 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.
[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 process 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 structures. 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 arbitrary 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 headband 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 reinforcement 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 headband. Here, the
padding body 5 is backed onto the reinforcement insert during a
flame backing process. A fleece material layer 8 is provided on the
rear side of the reinforcement 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 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 preferably
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 embodiment 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.
[0047] Instead of the elastic tension 22 provided in the 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 of the reinforcement insert 4.
Deformations and reinforcement insert 4 around the main axis z
extending perpendicularly 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 reinforcement
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 r1, 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 latticework-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.
[0051] In zones of an especially high bending load it is also
possible to provide a plurality of reinforcement inserts in the
headband, or to form the reinforcement layers with locally thicker
portions.
* * * * *