U.S. patent application number 15/034351 was filed with the patent office on 2017-06-08 for cushion element for a patient interface.
The applicant listed for this patent is 4A ENGINEERING GMBH, MEDIZINISCHE UNIVERSITAT GRAZ. Invention is credited to CORNELIS PETRUS HENDRIKS, ROLAND ALEXANDER VAN DE MOLENGRAAF.
Application Number | 20170157350 15/034351 |
Document ID | / |
Family ID | 51753225 |
Filed Date | 2017-06-08 |
United States Patent
Application |
20170157350 |
Kind Code |
A1 |
VAN DE MOLENGRAAF; ROLAND ALEXANDER
; et al. |
June 8, 2017 |
CUSHION ELEMENT FOR A PATIENT INTERFACE
Abstract
The present invention relates to a cushion element (14) for a
patient interface (10) for providing a flow of breathable gas to a
patient (12), wherein the cushion element (14) comprises a
face-contacting layer (32) for contacting a face of the patient
(12) during use of the cushion element (14) and a responsive layer
(34) which is covered by the face-contacting layer (32). The
responsive layer (34) comprises a plurality of active and passive
zones (38, 40) that are arranged alternately side by side to one
another. Each of the active zones (38) comprises at least one
actuator (42) for moving the face-contacting layer (32), and
wherein each of the passive zones (40) comprises a cushion material
that is arranged between the actuators (42). The face-contacting
layer (32) forms a corrugated or undulating surface (46) covering
both the active and the passive zones (38, 40), wherein first parts
(48) of said surface (46) covering the active zones (38) project
beyond or are recessed relative to second parts (50) of said
surface (46) covering the passive zones (40).
Inventors: |
VAN DE MOLENGRAAF; ROLAND
ALEXANDER; (GELDROP, NL) ; HENDRIKS; CORNELIS
PETRUS; (EINDHOVEN, NL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
4A ENGINEERING GMBH
MEDIZINISCHE UNIVERSITAT GRAZ |
Traboch
Graz |
|
AT
AT |
|
|
Family ID: |
51753225 |
Appl. No.: |
15/034351 |
Filed: |
September 30, 2015 |
PCT Filed: |
September 30, 2015 |
PCT NO: |
PCT/EP2014/072499 |
371 Date: |
May 4, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/02 20130101;
A61B 5/14503 20130101; A61M 2005/1583 20130101; A61B 5/14532
20130101; A61B 5/150412 20130101; A61M 25/01 20130101; A61M 16/0633
20140204; A61B 5/155 20130101; A61M 2005/1585 20130101; A61M
25/0102 20130101; A61B 5/150656 20130101; A61M 25/0606 20130101;
A61M 16/0605 20140204; A61M 5/14276 20130101; A61M 25/00 20130101;
A61B 5/150503 20130101; A61B 5/153 20130101; A61B 5/6852 20130101;
A61B 5/15003 20130101; A61M 5/158 20130101; A61M 2205/0272
20130101; A61M 2205/0283 20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 28, 2013 |
DE |
10 2013 224 431.2 |
Claims
1. A cushion element for a patient interface for providing a flow
of breathable gas to a patient, wherein the cushion element
comprises: a face-contacting layer for contacting a face of the
patient during use of the cushion element; and a responsive layer
which is covered by the face-contacting layer; wherein the
responsive layer comprises a plurality of active and passive zones
that are arranged alternately side by side to one another, wherein
each of the active zones comprises at least one actuator for moving
the face-contacting layer, and wherein each of the passive zones
comprises a cushion material that is arranged between the
actuators, wherein the face-contacting layer forms a corrugated or
undulating surface covering both the active and the passive zones,
wherein first parts of said surface covering the active zones
project beyond or are recessed relative to second parts of said
surface covering the passive zones.
2. The cushion element according to claim 1, wherein the actuators
are configured to move the first parts of said surface relative to
the second parts of said surface by expanding the active zones in a
first direction towards the face of the patient and/or by
contracting the active zones in a direction opposite the first
direction.
3. The cushion element according to claim 2, wherein the active
zones are configured to communicate with the passive zones via the
cushion material that is integrated in the responsive layer, such
that an expansion of the active zones causes a contraction of the
passive zones, and a contraction of the active zones causes an
expansion of the passive zones.
4. The cushion element according to claim 1, wherein the active and
passive zones are arranged in columns next to one another, wherein
columns forming the active zones and columns forming the passive
zones are arranged alternately side by side to one another.
5. The cushion element according to claim 2, wherein the columns
forming the active zones and the columns forming the passive zones
are arranged parallel to the first direction.
6. The cushion element according to claim 1, further comprising a
support layer for providing mechanical stability to the responsive
layer, wherein the support layer is arranged on a first side of the
responsive layer, and wherein the face-contacting layer is arranged
on a second side opposite the first side of the responsive
layer.
7. The cushion element according to claim 1, wherein the at least
one actuator of each active zone comprises an electroactive polymer
and an electrode for activating the electroactive polymer.
8. The cushion element according to claim 1, wherein each of the
active zones comprises a plurality of actuators.
9. The cushion element according to claim 2, wherein each of the
plurality of actuators comprises an electroactive polymer and an
electrode that is arranged transverse to the first direction.
10. The cushion element according to claim 2, wherein each of the
active zones has a width (w) of 100 .mu.m.ltoreq.w.ltoreq.100 mm,
said width (w) being measured in a second direction transverse to
the first direction.
11. The cushion element according to claim 1, wherein the plurality
of active zones are arranged in concentric closed loops.
12. The cushion element according to claim 1, wherein the cushion
element is one of a nose cushion, a mouth cushion and a forehead
cushion.
13. A patient interface for providing a flow of breathable gas to a
patient, wherein the patient interface comprises a cushion element
according to claim 1.
14. The patient interface according to claim 13, further comprising
a voltage source which is connected to the at least one actuator of
each active zone.
15. A pressure support system, comprising: a pressure generator for
generating a flow of breathable gas; and a patient interface for
providing the flow of breathable gas to a patient, wherein the
patient interface comprises a cushion element according to claim 1.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a cushion element for a
patient interface for providing a flow of breathable gas to a
patient. The present invention particularly relates to a cushion
element that is improved with respect to a more efficient
prevention of a formation of red marks within the face of the
patient. Still further, the present invention relates to a patient
interface and a pressure support system which make use of such a
cushion element.
BACKGROUND OF THE INVENTION
[0002] Patient interfaces, such as masks for covering the mouth
and/or nose, are used for delivering gas to a patient. Such gases,
like air, cleaned air, oxygen, or any modification of the latter,
are submitted to the patient via the patient interface in a
pressurized or unpressurized way.
[0003] For several chronic disorders and diseases, a long-term
attachment of such a patient interface to a patient is necessary or
at least advisable.
[0004] One non-limiting example for such a disease is obstructive
sleep apnea or obstructive sleep apnea syndrome (OSA). OSA is
usually caused by an obstruction of the upper airway. It is
characterized by repetitive pauses in breathing during sleep and is
usually associated with a reduction in blood oxygen saturation.
These pauses in breathing, called apneas, typically last 20 to 40
seconds. The obstruction of the upper airway is usually caused by a
reduced muscle tonus of the body that occurs during sleep. The
human airway is composed of walls of soft tissue which can collapse
and thereby obstruct breathing during sleep. Tongue tissue moves
towards the back of the throat during sleep and thereby blocks the
air passages. OSA is therefore commonly accompanied with
snoring.
[0005] Different invasive and non-invasive treatments for OSA are
known. One of the most powerful non-invasive treatments is the
usage of Continuous Positive Airway Pressure (CPAP) or Bi-Positive
Airway Pressure (BiPAP) in which a patient interface is connected
to a pressure generator via a patient circuit including one or more
tubes, wherein the pressure generator blows pressurized gas into
the patient interface and into the patient's airway in order to
keep it open. Positive air pressure is thus provided to a patient
by means of the patient interface that is worn by the patient
typically during sleep.
[0006] Examples for such patient interfaces are:
[0007] nasal masks, which fit over the nose and deliver gas through
the nasal passages,
[0008] oral masks, which fit over the mouth and deliver gas through
the mouth,
[0009] full-face masks, which fit over both the nose and the mouth
and deliver gas to both, and
[0010] nasal pillows, which are regarded as patient interfaces as
well within the scope of the present invention and which consist of
small nasal inserts that deliver gas directly to the nasal
passages.
[0011] The patient interface is usually positioned and donned to
the patient's head using some kind of headgear. Further, the
patient interface may comprise a forehead support. Such a forehead
support is often designed as a pad that touches the forehead of a
patient during use. It is often included in order to relief the
pressure which the patient interface exerts onto the nose
bridge.
[0012] Wearing a patient interface can be uncomfortable, since for
providing an airtight seal between the patient interface and the
patient's face, the patient interface has to be worn with a
sufficient level of pressure on the face. It is thus evident that
users of the patient interfaces experience a lot of disadvantages,
wherein the most prominent disadvantage is the formation of facial
red marks after a long-term usage of the patient interface. These
red marks result from occlusions of blood vessels which arise from
the pressure exerted by the patient interface.
[0013] A promising concept for preventing uncomfortable pressure
points, red marks, indentations, and overall prolonged discomfort
is the use of cushion elements that provide an alternating pressure
onto the skin of the patient. This restores the skin blood flow in
the depressurized part of the cushion element. One approach for
providing cushion elements with an alternating pressure
distribution is the use of electroactive polymers (EAPs) within the
cushion elements. Dielectric elastomer actuators (DEAs) are smart
material systems which produce large strains (up to 300%) and
belong to the group of EAPs. Based on their simple working
principle DEAs transform electric energy directly into mechanical
work. DEAs are lightweight and free shapeable.
[0014] A DEA is a thin and flexible electroactive polymer sheet
enclosed between two compliant electrodes. The thickness of the
electroactive polymer sheet is controlled by the applied electrode
voltage. Correspondingly, a thickness change results in elongation
change. So both the thickness as well as the elongation of the
sheet can be controlled. If applied to the skin, the alternating
dimensions will impose an alternating pressure or stretch to the
skin.
[0015] An example for a cushion element that includes EAP-actuators
is known from WO 2013/183018 A1. The EAP-actuators used therein
continuously alter the skin pressure distribution, provide a slow
massaging motion to the skin, and relieve high local pressure
peaks.
[0016] However, there is still room for improvement. One of the
main technical challenges is the technical design and arrangement
of such actuators within the cushion element. It is particularly
challenging to design and arrange the actuators in such a way that
static pressure points may be effectively avoided.
[0017] A typical way to produce an EAP actuator is to spin coat or
blade the polymer layer and to spray coat or paint the compliant
electrode. There is a need to segment the electrodes so that
alternating pressure (switching from segment A to segment B) can be
realized. However, these electrode-segments are placed at a certain
distance away from each other in order to prevent electric arcing
from one electrode to the other. The gap between the
electrode-segments is usually in the range of 1-2 mm and minimally
in the range of 200-500 .mu.m. This gap can be responsible for
static pressure points on the cushion element, which can lead to
red marks.
SUMMARY OF THE INVENTION
[0018] It is an object of the present invention to provide an
improved cushion element for a patient interface, wherein the
cushion element more effectively overcomes the problem of a red
mark formation due to static pressure points on or within the
cushion element. It is especially an object of the present
invention to provide a cushion element including one or more
actuators for providing an alternating pressure distribution within
the cushion element, wherein the technical design and the
arrangement of the actuators within the cushion element is
improved.
[0019] According to an aspect of the present invention, a cushion
element for a patient interface for providing a flow of breathable
gas to a patient is presented, wherein the cushion element
comprises:
[0020] a face-contacting layer for contacting a face of the patient
during use of the cushion element; and
[0021] a responsive layer which is covered by the face-contacting
layer;
[0022] wherein the responsive layer comprises a plurality of active
and passive zones that are arranged alternately side by side to one
another,
[0023] wherein each of the active zones comprises at least one
actuator for moving the face-contacting layer, and wherein each of
the passive zones comprises a cushion material that is arranged
between the actuators,
[0024] wherein the face-contacting layer forms a corrugated or
undulating surface covering both the active and the passive zones,
wherein first parts of said surface covering the active zones
project beyond or are recessed relative to second parts of said
surface covering the passive zones.
[0025] According to a further aspect of the present invention, a
patient interface comprising a cushion element of the
above-mentioned type is presented.
[0026] According to still further aspect of the present invention,
a pressure support system is presented which comprise a pressure
generator for generating a flow of breathable gas, and a patient
interface for providing the flow of breathable gas to a patient,
wherein the patient interface comprises a cushion element of the
above-mentioned type.
[0027] Preferred embodiments of the invention are defined in the
dependent claims. It shall be understood that the claimed patient
interface and the claimed pressure support system have similar
and/or identical preferred embodiments as the claimed cushion
element and as defined in the dependent claims.
[0028] The herein presented cushion element comprises a plurality
of actuators which are configured to move the face-contacting layer
of the cushion element in a predefined movement pattern in order to
prevent a formation of red marks within the face of the patient. In
contrast to prior art cushion elements of this type, the herein
presented cushion element provides an improved arrangement of the
actuators as well as an improved technical design of the cushion
element itself.
[0029] The cushion element comprises a face-contacting layer which
is configured to contact the face of the patient during use of the
cushion element. This face-contacting layer builds the top surface
of the cushion element. The face-contacting layer is preferably
realized as a continuous layer that (fully) covers a responsive
layer which is arranged below. The responsive layer is divided into
so-called active and passive zones. However, it shall be noted that
the terms "active" and "passive" shall not be considered to be
limiting or to imply any special meaning other than the following.
The active zones of the responsive layer are zones or areas in
which at least one actuator is arranged. The passive zones are
zones or areas in which a cushion material is arranged but no
actuator. The active and passive zones could alternatively also be
denoted as first and second zones. It shall be furthermore noted
that the term "a plurality of" shall mean "at least two".
[0030] It is important that the active and passive zones are
arranged alternately side by side to one another. This means that
each active zone is sandwiched between two neighbouring passive
zones, and each passive zone (except the passive zones arranged at
the border of the cushion element) is sandwiched between two
neighbouring active zones.
[0031] Since the actuators for moving the face-contacting layer are
only arranged in the active zones, an actuation of the actuators
will cause a direct movement of the active zones and the parts
(herein denoted as "first parts") of the face-contacting layer
covering and contacting the active zones. However, since the
passive zones are sandwiched in between the active zones, an
actuation of the actuators at least indirectly also causes a
movement of the passive zones of the responsive layer and the parts
(herein denoted as "second parts") of the face-contacting layer
covering and contacting the passive zones. This indirect movement
of the passive zones arises from the fact that cushion material,
which may be present in the active zones between the electrodes of
the actuators, is transferred to and from the passive zones due to
material movement as soon as the actuators deform the active zones
of the cushion element. It is therefore preferred that the cushion
material comprises a pliable, resilient and/or elastic material
that is deformable under pressure. Typical materials of this type
are elastomers, like silicon, acrylics or polyurethane.
[0032] The one or more actuators that are arranged in each of the
active zones of the cushion element are preferably configured to
move the face-contacting layer in a periodic manner.
[0033] A further characterizing feature of the herein presented
cushion element is the shape of the face-contacting layer. The
face-contacting layer forms a corrugated or undulating surface
which covers both the active and the passive zones. The first parts
of said corrugated or undulating surface cover and contact the
active zones, and the second parts of said corrugated and
undulating surface cover and contact the passive zones of the
responsive layer. The first and second parts of said surface are
thus also arranged alternately side by side to one another (similar
as the active and passive zones of the responsive layer). The first
parts preferably also contact the neighbouring second parts, such
that the corrugated or undulating surface is a continuously
connected surface. The term "corrugated or undulating surface"
shall mean that said surface is an uneven surface having
elevations/bumps and recesses. The first parts of said surface,
which cover the active zones, project beyond or are recessed
relative to the second parts of said surface, which cover the
passive zones. An activation of the actuators thus causes an
undulating or wavelike movement of the face-contacting layer. This
undulating or wavelike movement may be, but does not necessarily
have to be a periodic movement. This movement prevents static
pressure points and provides a smooth massaging effect in the face
of the patient.
[0034] It shall be noted that the elevations and recesses of the
face-contacting layer are not restricted to any special shape of
their cross-sections. The elevations and recesses of the
face-contacting layer may have any shape, like a cubical,
rectangular, round, conical or elliptical shape.
[0035] According to an embodiment of the present invention, the
actuators are configured to move the first parts of the corrugated
or undulating surface relative to the second parts of said surface
by expanding the active zones in a first direction towards the face
of the patient and/or by contracting the active zones in a
direction opposite the first direction. Thus, fairly simple and
cost-saving actuators may be used which either contract or expand
the cushion material within the active zones upon activation. The
first direction is preferably meant to denote a direction
transverse or perpendicular to the interface between the cushion
element and the patient's face during use.
[0036] The active zones are preferably configured to communicate
with the passive zones via the cushion material that is integrated
in the responsive layer, such that an expansion of the active zones
causes a contraction of the passive zones, and a contraction of the
active zones causes an expansion of the passive zones. Depending on
the movement of the active zones the cushion material is thus
pushed from the active zones into the neighbouring passive zones or
vice versa. If the actuators contract the active zones upon
activation of the actuators, the cushion material present in the
active zones in between the actuators will be pushed into the
neighbouring passive zones. This will automatically cause the
second parts of the face-contacting layer covering the passive
zones to bulge outwardly towards the patient's face, whereas the
first parts of the face-contacting layer covering the active zones
will be pulled-in at the same time. A deactivation of the actuators
would in this case cause the active zones to expand again, such
that the cushion material will be pulled in the active zones from
the neighbouring passive zones. This will cause the first parts of
the face-contacting layer to bulge outwardly towards the patient's
face, whereas the second parts of said layer will be pulled in. A
periodic activation and deactivation of the actuators thus causes
the corrugated or undulating surface of the face-contacting layer
to move in an undulating or wave-like manner. The pressure points
where the face-contacting layer touches the skin of the patient so
to say switch places during this movement of the cushion element.
The cushion element will alternately contact the patient's face
with the first parts and the second parts of the face-contacting
layer.
[0037] According to an embodiment, the active and passive zones are
arranged in columns next to one another, wherein columns forming
the active zones and columns forming the passive zones are arranged
alternately side by side to one another. The columns forming the
active zones and the columns forming the passive zones are
preferably arranged parallel to one another and parallel to the
first direction. It shall be noted again that this first direction
denotes the direction of the movement of the active zones towards
the patient's face, which movement is caused by the actuators. A
parallel arrangement of the active and passive zones furthermore
has the advantage that the switching pressure points are equally
distributed over the cushion element. This results in a
well-controllable and comfortable massaging effect of the patient's
skin that prevents a formation of red marks. Leakages occurring at
the interface between the patient's face and the cushion element
are also prevented, since it is ensured that either the first parts
or the second parts of the corrugated or undulating surface contact
the skin and thereby provide a sufficient seal.
[0038] According to a further embodiment, the cushion element
additionally comprises a support layer for providing mechanical
stability to the responsive layer, wherein the support layer is
arranged on a first side of the responsive layer, and wherein the
face-contacting layer is arranged on a second side opposite the
first side of the responsive layer. The responsive layer is in this
embodiment thus sandwiched between the support layer and the
face-contacting layer. It is especially preferred that each of the
active zones and each of the passive zones contact the responsive
layer with their first side and the face-contacting layer with
their second side.
[0039] The additional support layer is preferably configured to be
stiffer or less resilient than the face-contacting layer and/or the
responsive layer of the cushion element. In this way it is ensured
that the movement of the actuators is mainly translated into a
movement of the face-contacting layer and not into a movement of
the support layer.
[0040] According to a further embodiment, the at least one actuator
of each active zone comprises an electroactive polymer and an
electrode for activating the electroactive polymer. The
electroactive polymer material may be the same as the
before-mentioned cushion material. By the help of such
electroactive polymer materials, electric energy may be directly
transformed into mechanical work. Electroactive polymers provide
the advantage that they are lightweight and free shapeable. By
applying an alternating voltage to the electrodes the electroactive
polymer material may be forced to expand and contract
alternatingly. Examples of such electroactive polymer materials
are: piezoelectric polymers, electromechanical polymers, relaxor
ferroelectric polymers, electrostrictive polymers, dielectric
elastomers, liquid crystal elastomers, conjugated polymers, Ionic
Polymer Metal Composites, ionic gels, and polymer gels.
[0041] Even though the usage of such EAP actuators is preferred
according to the present invention, the above-mentioned actuation
and movement principle may also be accomplished with other types of
actuators. Instead of EAPs, light-activated materials could e.g. be
used as well. Other responsive materials, which could be used as
actuators for the present invention, are: electroactive composites,
electrostrictive ceramics or crystals, shape memory polymers,
photomechanical materials, magnetostrictive materials,
chemomechanical materials, and bimetal composites.
[0042] In order to amplify the movement of the face-contacting
layer while still being able to use relatively low voltages (low
energy), it is especially preferred that each of the active zones
comprises a plurality of actuators. In case of the use of EAP
actuators it is preferred that each of the plurality of actuators
comprises an electroactive polymer and an electrode that is
arranged transverse to the first direction. The electrodes are thus
arranged above each other, wherein the gaps between the electrodes
are filled up with the electroactive polymer material (the cushion
material). Some electrodes may belong to two neighbouring
actuators, whereas actuators arranged at the borders of the active
zones belong to only one actuator. The plurality of actuators in
each active zone may also be referred to as one common actuator
arrangement.
[0043] According to a further embodiment, each of the active zones
has a width (w) of 100 .mu.m.ltoreq.w.ltoreq.100 mm, said width (w)
being measured in a second direction transverse to the first
direction. Said width dimensions of the active zones ensure a large
enough but not too large movement of the first parts of the
corrugated or undulating surface.
[0044] According to a further embodiment, the active zones are
arranged in concentric closed loops. Such an arrangement is
especially preferred if the cushion element is realized as a nose
cushion or a mouth cushion. The passive zones will then similarly
be arranged in concentric closed loops sandwiched between the
active zones. This provides the advantage that even though the
face-contacting layer alternatingly moves in the above-mentioned
way during use, no pressure leakages occur, as the active and
passive zones so to say fully surround the nose and/or the mouth of
the patient. However, it shall be noted that such an arrangement is
not necessarily needed if the cushion element is realized as a
cushion or pad of a forehead support of the patient interface. Such
forehead cushions usually do not have to form a seal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] These and other aspects of the invention will be apparent
from and elucidated with reference to the embodiment described
hereinafter. In the following drawings
[0046] FIG. 1 shows an exemplary embodiment of a patient interface
in which a cushion element according to the present invention may
be applied;
[0047] FIG. 2 shows a backside of the patient interface shown in
FIG. 1; and
[0048] FIG. 3 shows a schematic cross section of an embodiment of
the cushion element according to the present invention, wherein
FIG. 3A shows the cushion element in a first operating state and
FIG. 3B shows the cushion element in a second operating state.
DETAILED DESCRIPTION OF THE INVENTION
[0049] FIG. 1 shows an exemplary embodiment of a patient interface
for delivering a flow of breathable gas to a patient. The patient
interface is therein in its entirety denoted by reference numeral
10.
[0050] In this embodiment the patient interface 10 is designed as a
full-face mask covering the mouth and the nose of a patient 12. It
shall be noted that the patient interface 10 may alternatively be
designed as a nose mask, a mouth mask or as a total face mask
without leaving the scope of the present invention.
[0051] The patient interface 10 comprises a cushion element 14 and
a mask shell 16. The cushion element 14 is designed to contact the
face of the patient 12 and to provide an airtight seal at the
interface between the patient's face and the patient interface 10.
The cushion element 14 usually comprises a soft material, like
silicon or any other rubber or suitable elastic material. The mask
shell 16 provides a flexible, semi-rigid or rigid support structure
for holding the cushion element 14. The mask shell 16 is usually
connected to the backside of the cushion element 14, wherein the
backside is meant to denote the side of the cushion element 14
opposite to the side of the cushion element 14 contacting the
patient's face during use. The mask shell 16 may either be
releasably or fixedly connected to the cushion element 14. The
cushion element 14 and the mask shell 16 thus together form a
cavity which is in this case designed to receive the mouth and the
nose of the patient 12. It shall be noted that the cushion element
14 and the mask shell 16 may alternatively be formed as one
integral piece.
[0052] On the opposite side directing away from the patient's face,
the mask shell 16 preferably comprises a connector 18. Via this
connector 18 the patient interface 10 may be connected to a hose
(not shown) via which a pressurized flow of breathable gas can be
submitted to the patient interface 10. The mask shell 16 is further
connected to a headgear 20. This headgear 20 is used for attaching
the patient interface 10 to the patient's head. According to the
exemplary embodiment shown in FIG. 1, the headgear 20 comprises a
rigid frame 22 and lower and upper headgear straps 24, 26. These
lower and upper headgear straps 24, 26 may be connected to the
frame 22 of the headgear 20 and used for donning the mask shell 16
and the cushion element 14 to the patient's face.
[0053] In the illustrated example the headgear 20 furthermore
comprises a forehead support 28. This forehead support 28 allows
stabilizing the patient interface 10 while being donned to the
patient's face. The forehead support 28 reduces the pressure that
is exerted onto the patient's nose during use. In order to make the
forehead support 28 as comfortable as possible, the forehead
support 28 furthermore comprises a forehead cushion 30 which is
attached thereto. This forehead cushion 30 is according to the
present invention also considered as a cushion element (similar as
cushion element 14).
[0054] FIG. 2 shows a schematic view of the patient interface 10,
the cushion element 14 and the forehead support 28 from the other
side, i.e. from the side with which the cushion element 14 and the
forehead cushion 30 contact the patient's face.
[0055] FIGS. 3A and 3B show a schematic cross section of the
cushion element 14 according to an embodiment of the present
invention. The multi-layer structure of the cushion element 14 is
therein illustrated in detail.
[0056] In the illustrated example the cushion element 14 basically
comprises three layers: a face-contacting layer 32, a responsive
layer 34 and a support layer 36. The face-contacting layer 32 forms
the top surface of the cushion element 14 that contacts the
patient's face during use. It may be made of a thin elastomeric
film and has the function to provide a skin-friendly interface. The
support layer 36 is arranged at the backside of the cushion element
14 that is usually connected to the mask shell 16. This support
layer 36 is preferably made of a rubber material that is stiffer
and less resilient than the materials from which the
face-contacting layer 32 and the responsive layer 34 are made. The
support layer 36 shall provide mechanical stability. However, it
shall be noted that this support layer 36 is not necessarily needed
if the function of providing mechanical stability is fulfilled by
the mask shell 16 itself. The responsive layer 34 would in this
case be sandwiched between the face-contacting layer 32 and the
mask shell 16 instead of being sandwiched between the
face-contacting layer 32 and the support layer 36 as shown in FIG.
3. Both alternatives are possible.
[0057] One of the central features of the presented cushion element
14 is the structure of the responsive layer 34. The responsive
layer 34 is split up into active zones/areas 38 and passive
zones/areas 40. Zones 38 are called active zones since these zones
of the responsive layer 34 are configured to actively move the
face-contacting layer 32. Zones 40 are denoted as passive zones
since these zones are not actively moved (actuated), but move
indirectly as soon as the active zones 38 are moved. This will
become more apparent from the explanations given below.
[0058] As it can be seen in FIGS. 3A and 3B, the active zones 38
and the passive zones 40 are arranged alternately side by side to
one another. The active and passive zones 38, 40 are in the shown
example arranged in parallel columns next to one another. Each
active zone 38 comprises a plurality of actuators 42. These
actuators 42 are configured to move the face-contacting layer 32 by
expanding the active zones 38 in a first direction 44 towards the
patient's face and/or by contracting the active zones 38 in a
direction opposite the first direction 44. The actuators 42 are
preferably configured to periodically expand and contract the
active zones 38 of the responsive layer 34. In order to realize
this movement the use of electrically actuated actuators 42 is
preferred. Such actuators 42 may, for example, be controlled in
such a way that the active zones 38 are contracted when the
actuators 42 are activated, whereas the active zones 38 are
expanded again when the actuators 42 are deactivated. However, it
is also possible to control such actuators 42 the other way around,
such that, they expand the active zones 38 when being activated and
contract the active zones 38 again when being deactivated. A
preferred embodiment for such actuators 42 will be explained
further below.
[0059] A further central feature of the cushion element 14
according to the present invention is the technical design and
structure of the face-contacting layer 32. In contrast to most
cushion elements 14 according to the prior art, this
face-contacting layer 32 is not formed as an even, flat surface,
but rather formed as an uneven, corrugated or undulating surface 46
(see FIGS. 3A and 3B). This surface 46 comprises several
interconnected segments which are herein denoted as first parts 48
and second parts 50 of the surface 46. The first parts 48 are the
parts of the corrugated or undulating surface 46 that cover the
active zones 38. The second parts 50 are the parts of the surface
46 that cover the passive zones 40. The first and second parts 48,
50 are therefore also arranged alternately side by side to one
another. Depending on the activation state of the actuators 42, the
first parts 48 of the surface 46 either project beyond or are
recessed relative to the second parts 50 of the surface 46. In the
exemplary embodiment shown in FIG. 3, FIG. 3A shows the deactivated
state of the actuators 42 and FIG. 3B shows the activated state of
the actuators 42. In this example, the first parts 48 thus project
beyond the second parts 50 in the deactivated state (see FIG. 3A),
whereas the first parts 48 are recessed relative to the second
parts 50 in the activated state of the actuators 42 (see FIG. 3B).
It is clear that the technical design may be chosen to be just the
way around.
[0060] Due to the above-mentioned structure of the cushion element
14, the face-contacting layer 32 does not contact the patient's
face along the whole surface 46 during use, but rather performs an
undulating or wavelike movement. This prevents static pressure
points which could otherwise lead to a formation of red marks
within the patient's face.
[0061] In the preferred embodiment illustrated in FIGS. 3A and 3B
the actuators 42 are designed as electroactive polymer (EAP)
actuators. In this case each EAP actuator 42 comprises two opposing
electrodes 52 and an electroactive polymer material 54 that is
arranged in between the electrodes 52. The electroactive polymer
material 54 may be either configured to contract or to expand as
soon as a voltage is applied to the electrodes 52. In the shown
example, the electroactive polymer material 54 is configured to
contract as soon as a voltage is applied thereto
[0062] It can be furthermore seen from FIGS. 3A and 3B that each
active zone 38 of the responsive layer 34 comprises a plurality of
electrodes 52 and electroactive polymer layers 54 arranged in
between them. The electrodes 52 are preferably arranged
perpendicular to the first direction 44, i.e. parallel to the first
parts 48 of the undulating surface 46.
[0063] FIG. 3B shows the activated state of the actuators 42, i.e.
the state in which a voltage is applied to the electrodes 52. By
comparing FIG. 3A with FIG. 3B it may be seen that the first parts
48 of the undulating surface 46 so to say change places with the
second parts 50 of the undulating surface 46 as soon as a voltage
is applied to the electrodes 52 of the actuators 42. This results
from the following fact: The active zones 38 communicate with the
passive zones 40 via the cushion material that is integrated in the
responsive layer 34. An activation of the actuators 42 causes the
active zones 38 to contract (see FIG. 3B). This contraction shifts
the material, which is present in between the electrodes 52, from
the active zones 38 into the passive zones 40. The second parts 50
of the undulating surface 46 will then bulge outwardly so that they
then project beyond the first parts 48 of the undulating 46. A
wavelike movement of the face-contacting layer 32 may thus be
achieved by alternately activating and deactivating the actuators
42 in the active zones 38 of the responsive layer 34. During this
movement the first parts 48 and the second parts 50 of surface 46
will be alternately in contact with the patient's face.
[0064] The actuators 42 of the above-mentioned exemplary embodiment
may be easily driven by a voltage source (e.g. a battery) which is
either integrated into the cushion element 14 itself or arranged at
another position on the patient interface 10. This voltage source
(not shown) is preferably connected to each of the actuators 42 via
a voltage converter. A simple microprocessor may be used to steer
the actuators 42 in the above-mentioned way.
[0065] The width w of the active and passive zones 38, 40 may be
designed in a relatively free manner. Experiments of the applicant
have shown that the best massaging effects may be achieved if the
width w ranges between 100 .mu.m and 100 mm.
[0066] It shall be further noted that the above-mentioned structure
of the cushion element 14 may not only be used in the main cushion
14 forming the airtight seal of the mask 10, but could
alternatively or additionally also be used in the forehead cushion
30. The only difference is that in the sealing cushion 14 one also
needs to take account for the sealing behavior such a cushion
element should fulfill. It is therefore preferred that the active
zones 38 and passive zones 40 of the responsive layer 34 are
arranged in concentric closed loops (see FIG. 2).
[0067] While the invention has been illustrated and described in
detail in the drawings and foregoing description, such illustration
and description are to be considered illustrative or exemplary and
not restrictive; the invention is not limited to the disclosed
embodiments. Other variations to the disclosed embodiments can be
understood and effected by those skilled in the art in practicing
the claimed invention, from a study of the drawings, the
disclosure, and the appended claims.
[0068] In the claims, the word "comprising" does not exclude other
elements or steps, and the indefinite article "a" or "an" does not
exclude a plurality. A single element or other unit may fulfill the
functions of several items recited in the claims. The mere fact
that certain measures are recited in mutually different dependent
claims does not indicate that a combination of these measures
cannot be used to advantage.
[0069] Any reference signs in the claims should not be construed as
limiting the scope.
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