U.S. patent application number 12/656466 was filed with the patent office on 2010-08-05 for patient interface structure and method/tool for manufacturing same.
This patent application is currently assigned to MAP Medizin-Technologie GmbH. Invention is credited to Achim Biener, Bernd Lang.
Application Number | 20100192955 12/656466 |
Document ID | / |
Family ID | 40637109 |
Filed Date | 2010-08-05 |
United States Patent
Application |
20100192955 |
Kind Code |
A1 |
Biener; Achim ; et
al. |
August 5, 2010 |
Patient interface structure and method/tool for manufacturing
same
Abstract
Component of a patient interface, particularly a cushion,
comprising a first part and a second part, wherein the second part
is made of a foamed material which is foamed-on the first part. A
Method and tool for manufacturing a component of a patient
interface, particularly a cushion, comprising the steps molding a
first part of the component and foaming a second part on the first
part.
Inventors: |
Biener; Achim; (Aufkirchen,
DE) ; Lang; Bernd; (Grafelfing, DE) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Assignee: |
MAP Medizin-Technologie
GmbH
Martinsried
DE
|
Family ID: |
40637109 |
Appl. No.: |
12/656466 |
Filed: |
January 29, 2010 |
Current U.S.
Class: |
128/206.24 ;
264/46.4; 425/588 |
Current CPC
Class: |
A61M 16/0616 20140204;
A61M 16/0633 20140204; A61M 16/06 20130101; A61M 16/0622
20140204 |
Class at
Publication: |
128/206.24 ;
264/46.4; 425/588 |
International
Class: |
A61M 16/06 20060101
A61M016/06; B29C 67/20 20060101 B29C067/20; B29C 45/16 20060101
B29C045/16 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 30, 2009 |
EP |
09001344.2 |
Claims
1. Method of manufacturing a component of a patient interface,
particularly a cushion, comprising the steps: molding a first part
of the component and foaming a second part on the first part.
2. Method according to claim 1, further comprising the steps:
handling the first part, the second part and/or the component,
wherein the first part constitutes and/or comprises the handling
structure.
3. Method of producing a component of a patient interface,
particularly according to claim 1, comprising the following steps:
a) providing a molding tool having a first mold part and a second
mold part which are adapted to define a first mold cavity there
between; b) providing, preferably injecting, a first material into
the first molding tool in order to provide a first part of the
component; c) removing the first part from the first cavity; d)
providing a third mold and a fourth mold part adapted to define a
second mold cavity between them; e) inserting the first part into
the second cavity; f) providing a second foamed material into the
second mold cavity in order to provide a foamed second part
integral with the first part.
4. Method according to claim 1, wherein the hardness of the first
part is higher than the hardness of the second part.
5. Method according to claim 1, wherein first part removed from the
first mold part and the second mold part and inserted into a third
mold part and/or a fourth mold part, thereby defining, preferably
in combination with the third mold part and/or the fourth mold
part, a second cavity for foaming on a second part on the first
part.
6. Method according to claim 1, wherein a third mold part and/or a
fourth mold part are provided having at least one pressure rim
structure and wherein the pressure rim structure(s) is/are
sealingly pressed against the first part for defining a merging
surface on the first part and/or for sealingly defining a second
cavity.
7. Method according to claim 1, wherein a first mold part and/or a
second mold part are provided having at least one negative pressure
rim structure and wherein the molded first part comprises at least
one pressure rim structure molded by the negative pressure rim
structure(s) of the first and/or second part.
8. Method according to claim 1, wherein mold parts are provided
having a sealing means, preferably a silicone sealing lip and/or
silicone sealing ring defining at least one pressure rim which
is/are sealingly pressed against the first part for defining a
merging surface on the first part and/or for sealingly defining a
second cavity.
9. Component of a patient interface, particularly a cushion,
comprising a first part and a second part, wherein the second part
is made of a foamed material which is foamed-on the first part.
10. Component according to claim 9, wherein the second part is a
foam, e.g., polyurethane foam or silicone foam and/or wherein the
first part is a plastic material, preferably a polymer or a
thermoplastic elastomer, which is preferably elastic or hard.
11. Component according to claim 9, wherein the merging or contact
surface of the first part is a plane, angled or U-shaped surface
structure along at least a portion of the component's
circumference, and wherein the second component is foamed-on the
first part such that it at least partly merges at the contact or
merging surface.
12. Component according to claim 9, constituting a face mask
cushion, a forehead pad, and/or a component of a headband for
securing a device at a wearer's head.
13. Component according to claim 9, comprising a pressing flange on
the first part, wherein the pressing flange, preferably at least
partly, defines the boundary of the merging surface.
14. Tool for manufacturing a component according to claim 9,
comprising first mold part, a second mold part, a third mold part
and a fourth mold part, wherein the first mold part and the second
mold part are adapted to define a first cavity, wherein a first
part is moldable in the first cavity, and wherein the third mold
part, the molded first part and/or the fourth mold part are adapted
to define a second cavity, and wherein one or more pressure
flange(s) is are provided integrally with the third mold part, the
fourth mold part and/or the molded first part, and wherein second
mold cavity is preferably adapted to contain the first part and to
be filled with a second foamed material.
15. Tool according to claim 14, wherein pressure-flange(s) is/are
adapted for sealingly contacting the third mold part, the first
part and/or the fourth mold part such that the merging surface
between the first part and the second part to be molded in the
second cavity is defined by the pressure flange.
16. Tool according to claim 14, wherein the third and/or fourth
mold part comprise a sealing means, preferably an O-ring or sealing
lip seated in a groove provided in the third and/or fourth mold
part, wherein the merging surface between the first part and the
second part to be molded in the second cavity is defined by the
sealing means.
Description
[0001] The invention relates to patient interfaces such as
breathing masks covering nose and/or mouth of a patient and
components or structures thereof as well as to methods for
manufacturing such patient interfaces or components thereof and
further relates to tools for manufacturing the same. Furthermore,
the present invention relates to cushions, pads, supporting
structures and/or sealing structures, such as mask cushions or
forehead pads etc. for a patient interface such as a breathing
mask. Moreover, the present invention relates to a patient
interface or component of a patient interface obtainable by a
method according to the present invention as well as to a tool for
producing such interface or component and/or for performing a
respective method.
[0002] The invention concerns, in particular, a pad or cushion and
a patient interface such as a breathing mask which is equipped with
such pad or cushion. An internal space of a breathing mask is
established by the patient interface in conjunction with sealing
contact of the pad or cushion with the surface of the face of a
user. This internal space is sealed in relation to the ambient
atmosphere in such a way that a pressure which is preferably
increased in relation to the ambient pressure can be obtained, e.g.
in phase-wise fashion, in the internal space of the patient
interface or breathing mask. Breathing masks of that kind are used
in particular in connection with the medical or therapeutic
administration of breathable gases and also in the technical
sector, for example in the sector of breathing apparatus
technology, and particularly for CPAP and BiPAP therapy. The
invention further concerns a sealing, contact and/or support
structure and a process and tool for the production thereof in
general.
[0003] Usually, with such patient interfaces, the sealing action in
relation to the surface of the face of the user of the interface is
achieved by a sealing lip structure. Such sealing lip structure,
e.g., extends in inwardly directed relationship around an opening
of the mask, and is made from an elastically deformable
material.
[0004] The sealing action achieved with sealing lips of that kind
generally increases with the pressure with which the sealing lip is
pressed against the surface of the face. In the case of
comparatively high contact pressures, in particular long-term use
of breathing masks of that kind can give rise to troubles.
[0005] Patient interfaces and patient interface structures or
components, e.g., sealing lips, are known in the prior art, for
example, in the field of face masks for delivering breathable air
to a patient. In such face masks, often hollow cushions or bent,
resilient lip-structures are used for providing contact zones for
contacting the face of the user in order to avoid dents and to
improve wearing comfort of the user. Furthermore, such structures
are used as a sealing structure for sealing the mask interior from
the exterior in the contact region where the mask rests on a user's
face.
[0006] A disadvantage of structures known in the art is that they
are complicated to manufacture and a number of manual manufacturing
steps is often necessary. Often a number of different parts is
manufactured wherein the parts are provided with connection
structures and have to be assembled to form the final product.
[0007] For examples, breathing masks are known which comprise an
individually molded part made of polyurethane foam which is loosely
fitted into the mask frame for constituting part of a face mask
cushion. However, this kind of assembly requires providing
structures in the mask seal, the mask body or both that allow for a
mechanical linkage between these at least two components. This
typically requires the use of additional materials to form
different parts of a mask structure, increases the complexity of
the design as well as the manufacture of the mask. This leads to
limitations in design due to the requirements of providing
connection structures, and requires a complex hand assembly or hand
manipulation for assembling the mask etc.
[0008] The solutions known in the prior art are in particular, not
easy to handle, not durable, complicated and expensive to
manufacture, not suitable for automating, not bio-compatible as
well as optically and hygienically objectionable. The known
solutions are further disadvantageous in that they do not or
insufficiently allow individualization and are less comfortable for
a wearer, particularly with regard to material properties such as
weight and hardness.
[0009] WO 2007/009182A1 refers to a respiratory mask and a method
for manufacturing a respiratory mask comprising a first component
formed from a material that is more rigid than the flexible
material, wherein the first component is formed onto the second
component by an over molding process.
[0010] WO 03/105921A2 relates to a mask cushioning and forehead pad
for a respiratory mask, and a method for its production comprising
a mask cushioning having zones with an increased cross section that
are configured in the mask cushioning, wherein the mask cushioning
material in said zones has different material properties in such a
way that the Shore hardness of the mask cushioning in the boarder
region is higher than in the core region. Although, this disclosure
is advantageous in that it provides a one piece hygienic component,
it still suffers from the above disadvantageous, particularly from
limitations in the design of the sealing structures and from
complex manufacturing methods.
[0011] It is an object underlying the present invention to provide
a patient interface or a component of a patient interface, such as
a cushion or pad, a method for manufacturing such patient interface
and/or component as well as a tool for manufacturing the same which
overcome the deficiencies of the prior art. Alternatively or
additionally, it is an object underlying the present invention to
provide a patient interface or component thereof which has an
improved sealing effect and/or an improved level of wearing
comfort. Alternatively or additionally, it is an object underlying
the present invention to provide a method for manufacturing a
patient interface or component thereof and/or a tool for
manufacturing the same which allows efficient and effective
production and handling of improved patient interfaces and/or
components thereof.
[0012] These objects are fulfilled with the features of the claims
wherein dependent claims relate to preferred features of the
present invention.
[0013] The present invention relates to a patient interface
structure or component, e.g., a breathing mask and components
thereof. Such components are, e.g., a pad or a cushion for
supporting and/or sealingly supporting a breathing mask or patient
interface on a user's skin. Moreover, the present invention relates
to a method and tool for manufacturing a patient interface or
patient interface component, particularly those according to the
present invention.
[0014] According to the present invention, a component of a patient
interface, such as a face mask, and in particular a patient
interface cushion comprises a first part and a second part, wherein
the second part is made of a foamed material which is foamed-on the
first part. The first and second parts are preferably parallelly
and/or subsequently co-molded. Preferably, the first and second
part have a different hardness wherein the first part is molded in
a first step and wherein the second part is subsequently molded-on
or foamed-on the first part. Preferably, the first part is made of
a hard material, particularly with regard to the second material,
and the second material is made of a soft material, particularly
with regard to the first material. Preferably, the first material
is harder than the second material.
[0015] Preferably, foaming-on of the second part to the first part
and the co-molding of the first part and the second part results in
the first and second part being formed integrally with one
another.
[0016] The method and tool according to present invention
particularly allow to mold a foamed part on or onto another part in
an easy, reliable, efficient and effective manner. In particular,
the present invention does not require that a component of a first
part and a foamed second part are formed by `surrounding` the first
part by a foamed material wherein the first part constitutes a
core. Preferably, there is no positive locking or form closure
needed for foaming or molding the second material to the first
material.
[0017] According to a further alternative or additional aspect, the
present invention relates to a component of a patient interface,
such as a breathing mask, and in particular to a patient interface
cushion comprising a support structure, such as a frame-component
and a cushion or undercushion for supporting the interface on a
patient's face. Preferably, the component further comprises a
membrane, particularly for sealing the cushion against a users
face.
[0018] According to a preferred aspect of the present invention,
the first part and the second part integrally merge at a merging or
contact surface constituting the contact area between said two
parts. Said merging surface preferably is a substantially plane
surface and/or a surface having a substantially plane
cross-section. Preferably, the merging or contact surface comprises
at least two distinct surface portions. Preferably, the merging or
contact surface comprises a first surface portion and the second
surface portion wherein the first surface portion and the second
surface portion are inclined towards one another.
[0019] Preferably, the merging or contact surface has a plane, an
elbow-shaped, u-shaped, recessed, cup-like, and/or hook-shaped
profile at least at a part of its cross-section. Preferably, the
merging or contact surface does not have undercuts. Also
preferably, the first portion and second portion solely merge via
such merging surface and/or are not connected by means of
structural or mechanical fastening means. Preferably, the contact
surface of the first material comprises bores and/or cavities which
are at least partly filled by the second material when foaming the
second material on the first material.
[0020] According to a preferred embodiment, the component of a
patient interface according to the present invention is a breathing
mask cushion for sealingly supporting a breathing mask on a
wearer's face, a forehead pad for supporting a breathing mask on a
wearer's face, part of a headband for securing a device such as a
breathing mask to a wearer's head or other parts or components for
contacting a wearer's body.
[0021] Preferably, such interface comprises a thin membrane for
sealingly contacting a user's skin and an undercushion being
thicker than the the membrane and being arranged--when viewed from
the patient--under or behind said membrane. Preferably, the second
part according to the present invention constitutes such
undercushion wherein the first part is adapted to support the
second portion and to connect it to a patient interface frame.
Preferably, the first part also comprises the membrane being
integrally formed therewith or being, preferably releasably,
attached thereto.
[0022] Thus, preferably, the membrane forms an outer portion of the
patient interface (cushion) for, preferably sealingly, contacting a
wearer's skin wherein the second part or undercushion is shielded
vis-a-vis the wearer's skin by the membrane and is attached,
preferably releasably, to the patient interface by means of the
first part. Thus, the second part preferably does not directly
contact the wearer's skin.
[0023] Preferably, a patient interface component, here e.g. a mask
cushion, comprises a membrane or sealing lip portion and a cushion
or undercushion comprising a connection portion for connecting it
to a mask frame. The membrane or sealing lip portion is preferably
an independent, non-integral part which is individually connected
to the mask frame. According to an alternative preferred
embodiment, the membrane or sealing lip portion is co-molded and
integrally formed with support portions of the patient interface,
such as, e.g., the mask frame and/or the first part according to
the preset invention. The mask cushion or undercushion comprises a
cushion portion and a connection portion. Preferably, the
connection portion corresponds to the first part as referred to
herein wherein the cushion portion corresponds to the second part
as referred to herein. The connecting portion or the first part and
the cushion portion or second part of the component, respectively,
form a merging surface or contact area along which the first and
second part merge. The second part is made of a foam or a foamed
material. Preferably, the second part is co-molded to or foamed-on
the first part along the contact area or merging surface.
[0024] The component according to the invention preferably forms an
undercushion of a breathing mask cushion which is shielded or
covered vis-a-vis a wearer by a membrane or sealing lip portion
which at least partially extends along and over undercushion
portion, respectively, when assembled to a mask frame.
[0025] Preferably, the second part is located in the mask interior
oriented or facing towards the outside environment of the mask or
towards a wearer, respectively whereas the first part of the mask
cushion is located in the mask interior oriented or facing towards
the inside of the mask or or away from a wearer, respectively.
[0026] Preferably, the first part is not or does not comprise a
foam or foamed material wherein the second part is made of or
comprises a foamed material. Preferably, the first part has a first
material characteristic and the second part has a second material
characteristic different from the first material characteristic.
Preferably, said characteristic is hardness. Preferably, the
(first) hardness of the first part is higher than the (second)
hardness of the second part.
[0027] Preferred materials are resilient or elastic materials
allowing application of different hardnesses. According to a
preferred embodiment, the first part comprises a polymer, e.g., a
polysiloxane; silicone; liquid silicone rubber, and/or
thermoplastic elastomer. According to a preferred embodiment, the
second part comprises foamed materials, e.g., foamed silicone
and/or foamed polyurethane. Preferably, the second part is made of
a material having visco-elastic properties.
[0028] The breathing mask cushion and patient interface,
respectively, preferably comprises a longitudinal axis extending
generally perpendicular to a contact plane in which the cushion or
interface substantially contacts a wearer. Preferably, at least a
portion of the contact region or merging surface between the first
part and the second part is parallel with regard to said axis
and/or said contact plane in which the cushion or interface
substantially contacts a wearer. Preferably, the contact region
comprises one or more, at least two and preferably three distinct
portions. According to a preferred embodiment the contact region is
directed towards one side of the first/second part only.
Preferably, the second part does not surround or include the first
part or portions thereof. Preferably, the contact region, the first
part and/or the second part are generally ring shaped. The ring can
be closed or can be open, i.e. a ring-segment. The method and tool
according to the present invention particularly allow to foam the
second part on the first part from one side only and onto
substantially plane surfaces, generally to any surface of the first
part.
[0029] In addition or alternatively, the present invention relates
to a method for producing a component of a patient interface or a
patient interface, respectively. In particular, the method
according to the present invention relates to the production of a
patient interface or component of a patient interface, such as a
breathing mask cushion, as discussed and disclosed in the present
application. A preferred method according to the present invention
comprises the steps of providing a molding tool having a first mold
part and a second mold part which are adapted to define a first
mold cavity therebetween for molding a first part of said patient
interface or patient interface component. A first material having
first material characteristics, such as a first hardness, is
injected into the first molding tool and into the first cavity
defined thereby in order to provide the first part of the
component. After said first material has been injected into the
first cavity and has at least partially solidified or fully
solidified the first mold cavity is opened and the first part is
removed. Preferably, the molded first part is ejected or removed
from the first mold part and is provided into a second cavity
formed between at least a third and a fourth mold part. The third
and fourth mold parts are designed and arranged so that the second
mold cavity is established, as discussed above. The second cavity
is larger than the first molded part so that a cavity is formed
between the third mold part, the fourth mold part, and/or the first
molded part.
[0030] A second material having a second material characteristic,
such as a second hardness, is then fed into the second mold cavity
in order to provide a second part integral with the first part. The
second material is provided as a foam or foamed material. This
includes that the second material is introduced or fed into the
second cavity in a foamed state and/or that the second material is
foamed inside the second cavity, e.g., by mans of a foaming agent.
Preferably, the second material is provided or fed into the second
cavity at elevated pressure and/or resulting in an elevated
pressure in the second cavity, e.g. by means of the foaming
agent.
[0031] Preferably, as discussed above with regard to the patient
interface or patient interface component according to the present
invention, the first material characteristic and the second
material characteristic, such as the first hardness and the second
hardness, differ from one another wherein, preferably, the first
hardness is larger than the second hardness.
[0032] The mold parts are preferably arranged around a turntable.
After the first part has been molded, preferably injection molded,
the first molded part is removed from the first mold cavity and the
first mold part is provided into the second mold cavity by turning
of the turntable and by placing it in a defined position in
relation to the third and fourth mold part so that it is positioned
in the second cavity. Then, the second part is molded.
[0033] After the second molding step with which the second material
of the second part has been provided or fed into the second cavity
is finalized the tool is opened and the patient interface component
can be ejected or withdrawn from the tool.
[0034] According to a further aspect of the present invention,
there is provided a tool for manufacturing a patient interface or a
patient interface component as discussed in the present application
and/or for performing a method as discussed in the present
application. Aspects of such tool have already been discussed in
combination with the patient interface component or the method of
the invention.
[0035] Such tool preferably comprises a first mold part and a
second mold part which are adapted to define a first mold cavity
therebetween. There is further provided a third mold part and a
fourth mold part adapted to define a second mold cavity
therebetween and/or between the first part of a patient interface
component and the third and/or fourth mold part.
[0036] Preferably, the first and second mold part define walls of
said first cavity whereas the third mold part, the fourth mold part
and/or the first molded part define walls of said second cavity.
The wall of said second cavity is preferably partly formed by or
comprises the merging surface or contact region formed by the first
molded part of the patient interface component.
[0037] The third mold part, the fourth mold part and/or the first
molded part preferably comprise at least one pressure-flange for
sealing the second cavity and preferably the first part against the
third mold part and/or the fourth mold part.
[0038] Preferably, the one or more pressure flange(s) is/are
designed and arranged such that it/they define(s) the merging
surface on the first part of the patient interface component. Thus,
the second cavity for molding the second part of the patient
interface component is sealed against the first molded part so that
a contact or merging surface is defined forming part of the walls
of the second cavity for molding the second part of the patient
interface on the first part at the merging surface.
[0039] In a preferred embodiment where at least one pressure flange
is provided on the first nolded part this is preferably achieved by
providing a negative form of the pressure flange by the first
cavity, preferably in the first mold part and/or the second mold
part such that the pressure flange is molded integrally with the
first molded part. The pressure flange(s) allow forming of a second
cavity by sealing the first molded part, and particularly the
merging surface of the first molded part against the third and or
fourth mold parts, respectively.
[0040] Preferably, the first and second mold part providing the
first cavity constitute an injection molding mold wherein the third
and fourth mold part providing the second cavity constitute a
foaming mold.
[0041] Alternatively and/or additionally to the embodiments
discussed above, the pressure flange(s) is/are preferably
constituted by the provision of a sealing ring, made of, e.g.
silicone material. Preferably, such sealing ring, e.g. in the form
of an O-ring or the like, is attached to the third and/or fourth
mold part(s) by the provision of a fastening groove for attaching
said ring type pressure flange to the third mold part and/or fourth
mold part. This embodiment comprising one or more silicone sealing
rings constituting one or more pressure flange(s) is particularly
preferred for manufacturing a second molded part made of
polyurethane foam.
[0042] The present invention is of particular advantage in that it
provides an improved patient interface and patient interface
component such as a breathing mask cushion with enhanced
characteristics. In particular, the patient interface and patient
interface component according to the present invention allows
improved comfort for a wearer and avoids reddening and pressure
marks occurring on a wearer's face. Moreover, the present invention
allows the provision of special and interchangeable geometries and
properties of a patient interface and a patient interface component
for improved compliance with a user's physiognomy and
anthropometry. The present invention particularly allows efficient
and effective production of improved patient interfaces and/or
components and an automated production. Moreover, optically and
hygienically as well as structurally improved patient interfaces
and patient interface components can be provided. In particular,
individualization and comfortable wearing of such improved patient
interfaces and patient interface components is allowed by the
technology discussed and disclosed in this application. Preferably,
the present invention additionally or alternatively allows the
provision of an improved usability of the molded product,
particularly by allowing the provision of a supporting structure
integrally combined with a softer, foamed part.
[0043] For example the use of a first and second molded part allows
the provision of a soft and comfortable material for e.g.
comfortably supporting a patient interface on a users skin and of a
harder material for providing improved haptic and hygienic
properties, for supporting the soft comfortable material, i.e., the
second portion, and/or for allowing the provision of, e.g.,
additional fastening means for, e.g., securing, preferably
releasably and interchangeably securing, a patient interface
component to a patient interface frame. A patient interface
according to the present invention preferably exhibits advanced
comfort to a wearer due to its light weight and the second parts
material properties, which are preferably visco-elastic.
[0044] The method and tool according to the present invention
particularly provide for an effective and efficient manufacturing
of an improved patient interface or patient interface component
having a improved characteristics. Also, the hardness and geometry
of the patient interface or patient interface component may be
easily adjusted or individualized without the need of an exchange
of expensive tool components. Rather, e.g., a first, second, third
and/or fourth mold part may be easily replaced or exchanged in
order to adjust the above-listed characteristics wherein the
remaining mold part(s) can be maintained. Moreover, the production
of an improved patient interface or patient interface component
with improved properties as regards comfort etc. is achieved in an
easy and cheap manner in an automized process. Also, the present
invention allows an improved production of harmonized and
exchangeable modules for patient interfaces wherein the interface
measures are maintained while only features relevant for the
individual improvement of the patient interface or patient
interface component are adjusted.
[0045] The present invention particularly and preferably has the
advantageous effect that it allows the provision of an improved
manufacturing process and that, e.g. during production gripping or
handling sections are comolded integrally with the first and/or
second molded part. These gripping or handling parts can preferably
be used for demolding the patient interface component and/or for
handling the patient interface component during subsequent
manufacturing and/or assembly steps. The gripping or handling parts
are preferably being provided on the harder, non-foamed first part.
Preferably, the gripping or handling parts are adapted to be easily
removed when they are not needed any more. Preferably, such
gripping or handling parts comprise a predetermined breaking point
zone. Additionally and/or alternatively, the gripping or handling
parts are provided on the first molded part. Preferably, these
gripping or handling parts, at least partly, constitute part of the
contact surface. Preferably, the second material is foamed on or
over the gripping or handling parts provided on the first molded
part. Thus, the present invention allows an improved and automated
manufacturing process. In particular, the present invention allows
to handle the first part by means of a handling part, e.g. from the
first cavity to the second cavity, wherein the handling part is
subsequently covered by the second
[0046] The structure of the component of the present invention and
particularly of the contact region or merging surface allows an
improved filling and/or venting of the foaming tool. Moreover, the
present invention preferably advantageously allows an easy and
efficient production of the first part with high tolerances and low
requirements or restrictions as regards the quality of the contact
region or merging surface since this surface will be contacted and
thus covered by the foamed second part. Furthermore, the preferred
structure, e.g., a plane-, u-, cup- or elbow-shaped structure, of
the merging surface of the first part allows to easily heal
deficiencies in the optical appearance of the foamed second
material. In particular, the preferred structures of the first part
allow, e.g., to cover voids, vent structures and/or the like of the
first part and/or foamed second part while at the same time
allowing a secure and advanced integral connection between the
first and second part.
[0047] The present invention particularly allows to manufacture one
part molded with different hardness zones and/or different
functionalities for use as, e.g., forehead pads (e.g., higher
hardness for the attachment mechanism to the mask and lower
hardness towards the patient), support portions of a headband or
string, or an enhanced cushion to be attached to standard or
harmonized frame interfaces.
[0048] The present invention furthermore allows to optimize the
structure of a patient interface and patient interface component,
respectively, based on e.g. different material characteristics.
Thus, e.g., the soft, preferably visco-elastic, foam can be used
for providing a cushion for in combination with a portion of higher
hardness for supporting the cushion, hidden behind and covering the
back of the cushion. This is also combinable with hard contact or
fastening or support area(s) towards a mask frame for attachment of
the component to the mask. At the same time, the production of such
patient interface component is achieved in an effective and
efficient manner.
[0049] According to preferred embodiments, the present invention
allows to co-mold a foamed low hardness undercushion to a high
hardness support, preferably in one tool. There is provided, e.g.,
a low hardness and vino-elastic separately molded foamed silicone
undercushion and a high hardness, preferably thin, support
structure. Preferably, one of the two parts, such as the foamed
second part comprises coloured particles so that is has a
predefined visual appearance. Preferably, the present invention
allows to manufacture such multi characteristic patient interface
or patient interface component in one part and in one tool. At the
same time it allows to be fitted to existing, non-modified frames.
The use of foam or a foamed material as the second part is of
particular advantage since it also allows, although not required,
the provision of, preferably small, undercuts in the connection or
merging surface between the first and second part. An advantageous,
effective and strong but small connection zone or merging surface
or design, particularly reduced in size, is achieved.
[0050] Preferably, the tool according to the present invention is
built as a tool on a turn table machine. The present invention
allows to adjust the hardness/geometry of the foamed undercushion
by changing only one mold half in the tool. It thus allows for
anthropometrical adjustments in the tool with limited effort and/or
costs.
[0051] In accordance with an aspect of the present invention there
is provided a patient interface component for a breathing mask
comprising a receiving opening which in the position of application
of the breathing mask coincides at least with the nose and/or mouth
opening region of a user of the mask, and a sealing lip which is
formed from an elastomer material and which extends around the
receiving opening and which in the application position fits on the
surface of the face of the user of the mask. Said patient interface
component may comprise zones of thickened and/or reduced
cross-section.
[0052] In that way it is advantageously possible to provide a mask
pad device which is distinguished by particularly high adaptability
to the most widely varying individual face structures.
[0053] The patient interface according to the invention can be of
such a nature that it can be fitted for example by way of a
peripheral edge portion in sealing relationship to a dish-shaped or
arch-shaped body in the form of a hard shell member. That makes it
possible for the mask pad device to be removed from the hard shell
member for cleaning, replacement, and/or adaptation purposes.
[0054] As an alternative to the measure described hereinbefore it
is also possible for the patient interface component to be formed
integrally with the dish-shaped or arch-shaped body. That avoids
the formation of a gap region between the patient interface or
interface component and the dish-shaped or arch-shaped body.
[0055] The patient interface component can be so designed that the
radial cross-sections, that is to say preferably the cross-sections
of the mask pad device, vary.
[0056] The above-described patient interface component forms a
component part of a patient interface such as a breathing mask
which, in the application position, engages over the nose and/or
the mouth region of the user of a mask. It can be used in a
corresponding configuration in relation to a nasal mask and also in
relation to a mouth or full-face mask.
[0057] The configuration according to the invention of the
cross-section of the elastomer structures can also be used in
relation to a forehead contact element. Thus, in accordance with a
further and also alternative concept, it is possible for forehead
contact pads to be of such a configuration that the deformation
characteristics thereof are imparted by foamed components.
[0058] Although the present application discusses the
provision/production of a first molded part and a second molded
part it is apparent for the person skilled in the art that also
third and further molded parts having individual characteristics
may be provided/produced.
[0059] Additional and/or alternative preferred embodiments of the
present invention are directed to the following aspects.
[0060] Method of manufacturing a component of a patient interface,
particularly a cushion, comprising the steps of molding a first
part of the component and foaming a second part on the first
part.
[0061] Method according to any one of the preceding aspects,
further comprising the step of handling the first part, the second
part and/or the component, wherein the first part constitutes the
handling structure.
[0062] Method of producing a component of a patient interface,
particularly according to any one of the preceding aspects,
comprising the following steps: providing a molding tool having a
first mold part and a second mold part which are adapted to define
a first mold cavity there between; providing, preferably injecting,
a first material into the first molding tool in order to provide a
first part of the component; removing the first part from the first
cavity; providing a third mold and a fourth mold part adapted to
define a second mold cavity between them; inserting the first part
into the second cavity; and providing a second foamed material into
the second mold cavity in order to provide a foamed second part
integral with the first part.
[0063] Method according to any one of the preceding aspects,
further comprising the step of foaming the second material,
preferably inside the second mold cavity and/or prior to providing
the second material into the second mold cavity.
[0064] Method according to any one of the preceding aspects,
wherein the hardness of the first part is higher than the hardness
of the second part. Method according to any one of the preceding
aspects, wherein the second part is visco-elastic.
[0065] Method according to any one of the preceding aspects,
wherein the second material is co-molded to the first portion.
Method according to any one of the preceding aspects, wherein first
part removed from the first mold part and the second mold part and
inserted into a third mold part and/or a fourth mold part, thereby
defining, preferably in combination with the third mold part and/or
the fourth mold part, a second cavity for foaming on a second part
on the first part.
[0066] Method according to any one of the preceding aspects,
wherein the first and/or second material comprises a color,
preferably a differing color.
[0067] Method according to any one of the preceding aspects,
wherein a third mold part and/or a fourth mold part are provided
having at least one pressure rim structure and wherein the pressure
rim structure(s) is/are sealingly pressed against the first part
for defining a merging surface on the first part and/or for
sealingly defining a second cavity.
[0068] Method according to any one of the preceding aspects,
wherein a first mold part and/or a second mold part are provided
having at least one negative pressure rim structure and wherein the
molded first part comprises at least one pressure rim structure
molded by the negative pressure rim structure(s) of the first
and/or second part.
[0069] Method according to any one of the preceding aspects,
wherein mold parts are provided having a sealing means, preferably
a silicone sealing lip and/or silicone sealing ring defining at
least one pressure rim which is/are sealingly pressed against the
first part for defining a merging surface on the first part and/or
for sealingly defining a second cavity.
[0070] Component of a patient interface, particularly a cushion,
comprising a first part and a second part, wherein the second part
is made of a foamed material which is foamed-on the first part.
Component according to the previous aspect, wherein the first part
has a hardness greater than the hardness of the second part.
[0071] Component according to and one of the previous aspects,
wherein the second part is a foam, e.g., polyurethane foam or
silicone foam.
[0072] Component according to any one of the previous aspects,
wherein the first part is a plastic material, preferably a polymer
or a thermoplastic elastomer, which is preferably elastic or
hard.
[0073] Component according to any one of the previous aspects,
wherein the merging or contact surface of the first part is a
plane, angled or U-shaped surface structure along at least a
portion of the component's circumference, and wherein the second
component is foamed-on the first part such that it at least partly
merges at the contact or merging surface.
[0074] Component according to any one of the previous aspects,
wherein the first portion comprises a thin membrane having a
thickness of preferably about 0.1 to 1 mm and more preferably of
about 0.35 mm.
[0075] Component according to any one of the previous aspects,
wherein the component forms a cushion or an undercushion of a
patient interface and wherein the second part forms the cushion or
under-cushion, and wherein the first part forms a support structure
that is adapted to be connected, preferably releasably connected,
to a frame of the patient interface.
[0076] Component according to any one of the previous aspects,
wherein the contact area between the first and second part is a
substantially plane surface and/or a surface having a substantially
plane cross-section.
[0077] Component according to any one of the previous aspects,
constituting a face mask cushion, a forehead pad, and/or a
component of a headband for securing a device at a wearer's
head.
[0078] Component according to any one of the previous aspects,
comprising a pressing flange on the first part, wherein the
pressing flange, preferably at least partly, defines the boundary
of the merging surface.
[0079] Component according to any one of the previous aspects,
manufactured according to a method according to any one of the
preceding aspects.
[0080] Tool for manufacturing a component according to any one of
the previous aspects and/or for performing a method according to
any one of the previous aspects, comprising first mold part, a
second mold part, a third mold part and a fourth mold part, wherein
the first mold part and the second mold part are adapted to define
a first cavity, wherein a first part is moldable in the first
cavity, and wherein the third mold part, the molded first part
and/or the fourth mold part are adapted to define a second cavity,
and wherein one or more pressure flange(s) is are provided
integrally with the third mold part, the fourth mold part and/or
the molded first part.
[0081] Tool according to any one of the previous aspects, wherein
pressure-flange(s) is/are adapted for sealingly contacting the
third mold part, the first part and/or the fourth mold part such
that the merging surface between the first part and the second part
to be molded in the second cavity is defined by the pressure
flange.
[0082] Tool according to any one of the previous aspects, wherein
the first mold cavity is adapted to be filled with a first material
in a first molding, preferably injection molding, step and wherein
the second mold cavity is adapted to contain the first part and to
be filled with a second foamed material.
[0083] Tool according to any one of the previous aspects, wherein
the third and/or fourth mold part comprise a sealing means,
preferably an O-ring or sealing lip seated in a groove provided in
the third and/or fourth mold part, wherein the merging surface
between the first part and the second part to be molded in the
second cavity is defined by the sealing means.
[0084] A breathing mask comprising: a component according to any
one of the previous aspects and/or a component manufactured by a
method according to any one of the previous aspects or by a tool
according to any one of the previous aspects.
[0085] Use of a tool according to any one of the previous aspects
to perform a method according to any one of the previous aspects
and/or for manufacturing a component according to any one of the
previous aspects.
[0086] Other aspects, features, and advantages of this invention
will become apparent from the following detailed description when
taken in conjunction with the accompanying drawings, which are a
part of this disclosure and which illustrate, by way of example,
principles of the invention.
[0087] The accompanying drawings facilitate an understanding of the
various embodiments of this invention. In such drawings:
[0088] FIG. 1 is a schematic three-dimensional cross-sectional view
of a patient interface component of the present invention, here a
patient interface cushion with a support structure;
[0089] FIG. 2 shows a schematic view of the cross-section of the
component according to in FIG. 1;
[0090] FIG. 3 shows a schematic three-dimensional cross-sectional
view of another embodiment of a patient interface component
according to the present invention, here a patient interface
cushion with a support structure;
[0091] FIG. 4 shows a schematic view of the cross-section of the
component according to FIG. 3;
[0092] FIG. 5 shows a three-dimensional schematic view of a
component according to the present invention, here a patient
interface cushion with a support structure; and
[0093] FIGS. 6a to 6d show preferred embodiments of components
according to the present invention wherein FIGS. 6a and 6b show
preferred embodiments of the component according to the present
invention in combination with further structures of a patient's
interface component, here a breathing mask and wherein FIGS. 6c and
6d show further preferred embodiments of the component according to
the present invention.
[0094] The following description is provided in relation to several
embodiments which may share common characteristics and features. It
is to be understood that one or more features of any one embodiment
may be combinable with one or more features of the other
embodiments. In addition, each single feature or combination of
features in any of the embodiments may constitute an additional
embodiment.
[0095] In this specification, the word "comprising" is to be
understood in its "open" sense, that is, in the sense of
"including", and thus not limited to its "closed" sense, that is
the sense of "consisting of". A corresponding meaning is to be
attributed to the corresponding words "comprise", "comprised" and
"comprises" where they appear.
[0096] In accordance with the present invention, FIG. 1 shows a
three-dimensional schematic cross-sectional view of a patient
interface structure or component 1 according to the present
invention. The patient interface structure comprises a first part 2
and a second part 3 wherein the second part 3 is made of a foamed
material which is foamed on the first part 2. The first part 2 and
the second part 3 integrally merge at a merging surface 5 (5a, 5b)
which constitutes the contact area between the first part 2 and the
second part 3. According to the embodiment shown in FIG. 1, the
first part 2 constitutes a frame or a support portion wherein the
second part 3 constitutes a cushion or under cushion portion of the
patient interface. The patient interface component 1 according to
the present invention, and preferably its first portion 2,
preferably comprises structural fastening or connection means 4 for
connecting the patient interface component 1 to a patient interface
structure such as a breathing mask or a mask frame.
[0097] The second part 3 is made of or comprises a foamed material
or a foam material, preferably silicone foam or polyurethane foam.
The first part 2 preferably is or comprises a plastic material such
as a polymer, or thermoplastic elastomer. Preferably, the first
part 2 has a greater hardness than the second part 3. Furthermore,
preferably, the material of the second part 3 has greater
elasticity and/or viscoelastisity than the material of the first
part 2.
[0098] FIG. 2 shows a schematic cross-sectional view of the cross
section shown on the right hand side in FIG. 1. As shown in FIGS. 1
and 2 the contact or merging surface 5 between the first part 2 and
the second part 3 comprises two distinct surface portions 5a, 5b
which are inclined toward to another by an angle, preferably of
about 90.degree., and form a contiguous contact zone or merging
surface 5.
[0099] During manufacturing, the first part (first molded part) 2
is molded in a first mold cavity between a first mold part (not
shown) and a second mold part (not shown). After molding of the
first part 2, the first molded part 2 is removed from the mold and
is inserted into a second cavity formed or to be formed between a
third mold part 7 and a fourth mold part 9. Preferably, the third
mold part 7 and the fourth mold part 9 define a second cavity
between them. Preferably, the first molded part 2 is located in
said second cavity wherein the second cavity is larger than the
first molded part 2. Thus, once the first molded part 2 is inserted
into the cavity formed between the third and fourth mold part and
the third and fourth mold parts are closed still a cavity remains.
This remaining cavity is also referred to a second cavity herein.
Preferably, a part of the wall of said second cavity is defined by
the first part 2 contained between the third mold part 7 and/or the
fourth mold part 9. Said second cavity being for molding the second
part 3.
[0100] The second cavity and thus the second part 3 preferably has
varying dimensions and measures, particularly along the
circumference of the patient interface, and/or the contact surface
5 preferably has varying dimensions and measures, particularly
along the circumference of the patient interface. This is shown,
e.g. in FIG. 1.
[0101] Generally, it is to be noted that the third mold part, the
fourth mold part or any further mold parts according to the present
invention can be constituted by one, two or more individual parts.
For example, in the embodiment shown in FIG. 2, the fourth mold
part 9 can be defined by two mold parts 9a and 9b (not shown).
[0102] The fourth mold part 9 and/or the third mold part 7 comprise
a pressure-flange 11 for sealingly contacting the first molded part
2 contained in the second cavity between the third mold part 7 and
the fourth mold part 9.
[0103] Preferably, the pressure flange(s) is(are) designed and
arranged such that it(they) defines (define) the contact of merging
surface 5 on the first part 2 of the patient interface component 1.
Thus, the second cavity for molding the second part 3 of the
patient interface component 1 is sealed against the first molded
part so that a contact or merging surface 5 is defined forming part
of the walls of the second cavity for molding the second part 3 of
the patient interface 1.
[0104] Additionally or alternatively, at least one pressure flange
11, and preferably two pressure flanges 11 (11a, 11b) is/are
provided on the third mold part 7, the fourth mold part 9 and/or
the first part 2. In a preferred embodiment, where a pressure
flange 11 is provided on the first part 2 this is preferably
achieved by providing a negative form of the pressure flange 11 in
the first mold part and/or the second mold part such that the
pressure flange 11 is molded integrally with the first part 2. The
pressure flange(s) 11 allow forming of a second cavity by sealing
the first part 2, and particularly the merging surface 5 of the
first part 2 against the third and/or fourth mold part.
[0105] The second cavity is then filled with a foamed material for
forming the second part 3. Preferably, a second material and/or a
foaming agent are provided into the second cavity such that the
second cavity is filled with a foamed or foaming material that
contacts and merges with the first part 2 at merging or contact
surface 5.
[0106] The contact or merging surface 5 can be a surface lying in
one plane, or, as shown, e.g., in FIGS. 1 and 2, a surface having
surface portions lying in two or more planes. In FIG. 2, a third
mold art 7 and a fourth mold part 9 have been schematically and
exemplarily indicated. The third mold half 7 is shown to comprise a
pressure flange 11, preferably two pressure flanges 11a and 11b,
which sealingly contact(s) the first part 2. Each pressure flange
11 is arranged and designed such that it defines a, or part of a,
contact or merging surface 5. Preferably, each pressure flange 11
is of a continuous structure such that there is defined an
enclosed, clearly defined individual contact or merging surface 5
on the first part 2. Preferably, the pressure flange(s) have a
continuous, ring like shape so that a continuous boundary of the
merging surface 5 is defined. This can also be achieved by
providing two or more pressure flanges which supplement one another
to define such merging surface. Preferably, merging surface 5 is of
ring like shape, and is preferably defined by two ring like
pressure flanges.
[0107] Preferably there will be provided two endless or loop-like
pressure flanges 11a and 11b extending all around the circumference
of a molded first part 2 and define between them the contact or
merging surface 5. This is of particular advantage for molding a
patient interface components as shown in FIG. 1, 3, or 5 (discussed
below) which are of generally circular, oval or triangular but
generally ring-like shape. Alternatively, the pressure rim or
pressure flange has a ring-like structure enclosing, inside said
structure, the merging surface 5. In such case, the patient
interface component does not need to be generally ring-shaped,
e.g., in case of a forehad cushion or a headband support.
[0108] Alternatively, pressure rim or pressure flange 11 can also
be provided on the fourth mold half 9.
[0109] The pressure flange or pressure rim 11 preferably seals the
second mold cavity against the first part 2. Thus, the second mold
cavity is defined by the contact or merging surface 5 of the first
part 2 and surface portions of the first mold part 7 and/or the
third mold part 9. Preferably, at least one of the pressure flanges
has an interruption, particularly in order to provide, e.g., a
sprue or a venting structure.
[0110] The embodiment shown in FIGS. 3 and 4 basically corresponds
to the embodiment discussed above with regard to FIGS. 1 and 2. It
is thus referred to the above discussion. The embodiment shown in
FIGS. 3 and 4 differs from the embodiment discussed above e.g. with
regard to the structure and design of the contact surface 5. As can
be seen in the cross-sectional view according to FIG. 3, the shape
and structure of the contact surface 5 may vary along its length,
here along the circumference of the patient interface component. As
shown on the left hand side in FIG. 3, a contact surface 5 (here
referred to as 5c) is a plane surface. Compared thereto, on the
right hand side in FIG. 3 a contact surface 5 comprises different
surface sections referred to as 5d, 5e, 5f, 5g, 5h. In its general
structure, the contact or merging surface 5 on the right hand side
of FIG. 3 has a U-shaped structure with flange portions 5d, 5h at
the opening of the U. In other words, contact surface 5 on the
right hand side of the embodiment shown in FIG. 3 comprises a
depression or groove 6 defined by surface portions 5e, 5f and
5g.
[0111] As shown in FIG. 4, such structure or merging surface 5 can
be manufactured by using a tool comprising a third mold half 7 and
a fourth mold half 9 wherein the third mold half 7 comprises a
pressure rim 11d for sealingly contacting the first molded part 2
and defining one border or boundary of contact surface 5. Fourth
mold half 9 comprises a second pressure rim 11c for sealingly
contacting the first part 2 and defining a second border or
boundary of contact surface 5.
[0112] The discussions provided above with regard to the definition
of the second cavity or the structure of the tool etc. also apply
to the embodiment shown in FIGS. 3 and 4.
[0113] According to the present invention, the pressure rim(s) 11
provided on one or more of the mold halves and/or the first part 2
is/are a thin, preferably sharp rim or protrusion. Pressure
flange(s) 11 is/are pressed against and into the material of the
first part 2 and/or the mold halves in order to sealingly define
the second cavity as discussed above. Pressure flange(s) 11 is/are
either pressed against and into the molded first part 2 by pressing
a mold part 9 and thus the pressure flange(s) against the first
part 2. Additionally or alternatively, one or more pressure
flange(s) 11 sealingly abut(s) the first part 2 since it/they
already form part of the third mold part 7 in which the first part
2 is inserted.
[0114] Preferably, the pressure flange protrudes from the remainder
of the mold halves surfaces. Preferably, the pressure rim has a
tapered or pointed configuration.
[0115] The shape and arrangement of the contact or merging surface
is preferably adapted to apply certain structural features being
advantageous for the molding process, the tool design and/or the
final product, e.g. a patient interface component. According to a
preferred embodiment, the design of the merging surface 5 changes
along the circumference of the first part 2, preferably in order to
exhibit certain functionalities and advantages discussed herein at
predefined positions of a wearer's face. For example, a contact or
merging surface 5 comprising two angled surface components, such as
surface portions 5a and 5b shown in FIGS. 1 and 2, allows a clear
positioning of the second part with respect to the first part and
thus with respect to the remainder of the patient interface. For
example, according to a preferred embodiment, the first part 2
defines a connection structure for connecting the second part 3,
preferably an under-cushion of a patient interface, to the face
mask thereby facilitating guidance, connectability,
exchangeability, individualizeability etc. of the patient interface
component and thus the patient interface according to the present
invention. This preferably allows a decoupling of the softer second
part 3 from the mask body by means of the first molded part 2
serving as an adapter.
[0116] Alternatively or additionally, the design of the contact or
merging surface 5 is chosen to influence the hardness, elasticity
and support functionality of the patient interface component and
particularly of the foamed second part 3, preferably constituting a
patient interface under-cushion.
[0117] Furthermore, contact surface shapes as shown in FIG. 2 or
FIG. 4 allow a foaming of the second part 3 onto the first part 2
such that any potentially hygienically and/or optically
deteriorated parts or surfaces of the foamed second part 3 are
hidden and sealed by the merging surface 5, e.g. in the corner of
merging surface portions 5a and 5b according to FIG. 2 or in the
recess 6 formed by surface portions 5f, 5g, 5h according to FIG. 4.
Preferably, the mold parts constituting the second mold cavity for
forming the foamed second part 3 are designed and arranged such,
e.g. with regard to gravity, that any potentially deteriorated
and/or visually or hygienically disadvantageous part of the foamed
second part and/or the merging surface 5 is covered or sealed as
discussed above.
[0118] According to a further preferred embodiment of the present
invention, venting structures 13 are formed into the first molded
part 2, preferably while molding the first part 2. Preferably, the
respective venting structures or channels are provided in or at the
contact or merging surface 5 and, preferably, in or at those
portions discussed above as being suitable for hiding and sealing
certain parts of the second part. E.g., in FIG. 4, a venting
structure 13 is exemplary depicted as being provided in merging
surface portion 5f in groove 6.
[0119] Alternatively and/or additionally to the embodiments
discussed above, pressure flange 11 can also be constituted by the
provision of a sealing means or sealing ring, made of, e.g.
silicone material. Preferably, such sealing ring, preferably in the
form of, e.g. a sealing lip, a flexible sealing means, an O-ring or
the like, is attached to the third and/or fourth mold part(s) by
the provision of a fastening groove for attaching said sealing
means to the third mold part and/or fourth mold part. This
embodiment comprising one or more silicone sealing structures or
rings constituting pressure flange(s) is particularly preferred for
manufacturing a second part 3 made of polyurethane foam.
[0120] According to a preferred embodiment, the pressure rim(s) are
provided on the first part 2 for sealingly contacting the fourth
mold part 9. In this case, the pressure flange(s) 11 is/are part of
the molded first part 2. This is preferably achieved by providing a
first and/or second groove or recess of the negative shape of the
pressure flange 11 in the first mold part 7 and/or the second mold
part so that the molded first part integrally comprises the
pressure flange 11.
[0121] According to a preferred embodiment, the first molded part 2
is designed such that it comprises a membrane forming a sealing lip
for sealingly contacting a user's skin.
[0122] FIG. 6a shows a component according to the present invention
comprising a first molded part 2 and a second foamed part 3 being
attached to a mask frame 14. Further attached to mask frame 14 is a
membrane 15 which extends over second foamed part 3. Preferably,
membrane 15 and/or component 1 (comprising first molded part 2 and
second part 3) are releasably attached to mask frame 14 by means of
respective fastening means (not shown). Preferably, membrane 15
extends over component 1 so that when the breathing mask is worn by
a patient, membrane 15 contacts the user's skin wherein the mask is
supported on the user's skin by means of component 1, i.e., foamed
second part 3 constituting a mask cushion or undercushion which is
held or supported by means of first molded part 2 which is
connected to the breathing mask via mask frame 14. Preferably,
membrane 15 is a silicone membrane.
[0123] FIG. 6b shows the use of a component 1 according to the
present invention similar to the embodiment discussed with regard
to FIG. 6a. As with the embodiment shown in FIG. 6a, membrane 15 is
releasably attached to frame 14 wherein membrane 15 supports,
covers, protects, and/or extends over component 1. Contrary to the
embodiment shown in FIG. 6a, membrane 15 according to FIG. 6b
comprises a cavity or recess 16 which preferably allows a good
gliding and dampening function of membrane 15. Membrane 15 also
comprises an abutment surface 17 which preferably supportingly
abuts against component 1.
[0124] FIG. 6c shows a first part 2 inserted in third mold half 7.
Mold part 2 as a generally u-shaped contour in the cross-section
according to FIG. 6c, wherein the ends of the generally u-shaped
contour of first element 2 are bent. Thus, corresponding to the
embodiment shown and discussed with regard to FIG. 4, merging
surface 5d and 5h are formed. Preferably, at least one bent or bent
end of the generally u-shaped contour of first element 2 extends
beyond a second foam part 3. A respective extension 18 is indicated
in FIG. 6c. It will be apparent for the person skilled in the art
that a respective extension can be formed on both ends of u-shaped
contour of first element 2. Additionally and/or alternatively, a
respective configuration can also be achieved with the embodiment
shown in FIG. 7.
[0125] Extension 18 provides an additional advantageous possibility
to apply a pressure rim (not shown in FIG. 6c) to define merging
surface 5h and to prevent foam or second foamed part 3 to extend
beyond boundary point/line 19.
[0126] With regard to gravity, when foaming second part 3 onto
first part 2, first part 2 is arranged in the upper part of the
tool whereas second foamed part 3 constitutes the lower part of the
tool. Accordingly, the foam constituting of building second foamed
part 3 will build up from the lower part of the cavity (which is
the upper end of second foamed part 3 according to FIG. 6c) and be
build up or filled up to first molded part 2.
[0127] As already indicated, first part 2 and/or second part 3
preferably comprise the same or different colour pigments allowing
to indicate, e.g., different sizes and/or structural features of
component 1.
[0128] The preferred embodiment according to FIG. 6d generally
corresponds to the one discussed with regard to FIG. 6c wherein
extensions 18 are provided on both ends of first parts 2 generally
u-shaped contour. In addition, second part 2 comprises venting
structures 13 which can be used for venting and/or filling of the
second cavity for molding or foaming the second foamed part 3.
[0129] The present invention, particularly the method according to
the present invention and the tool according to the present
invention allow an advantageous foaming of a second part on a first
part which has been proven to be either not possible or
disadvantageous as discussed in the introductory portion of the
specification. In this context, it is particularly to be noted that
material to be foamed or foamed material is generally a liquid
material having a low viscosity and is formed under pressure so
that the achievement of a reliable easy, efficient and effective
seal in accordance with the present invention is of great
advantage. Such material to be foamed or foamed material
furthermore generally exhibits sticky characteristics. Thus, the
present invention it is of advantage in order to avoid the
production of deficient parts or clogging of the mold parts. Thus,
according to the present invention, there is no need to cut off or
stamp out certain parts of the foamed material or to clean any
remaining surfaces of the mold parts or the first molded part.
[0130] The present invention moreover or alternatively allows
improved connection and/or mounting of the foamed second part. The
foaming of the second part on the first molded part preferably
provides improved tolerances and/or sealing properties of the
molded first and/or part against the remaining mask components
and/or a patient's face. Preferably, the present invention
additionally or alternatively allows selective stiffening or
reinforcing of the foamed second part by designing the first molded
part and/or the merging surface accordingly. This leads to improved
sealing properties of a patient interface component in line with
the present invention. Correspondingly, the present invention
allows improved automating of production and particularly of the
deforming of the foamed part and subsequent manufacturing steps
such as flash removing. Preferably, also the filling and/or venting
of the second cavity is improved. The present invention preferably
alternatively or additionally allows the application of colour,
such as coloured codes, to the molded parts, such as the foamed
second part. Correspondingly, automation of the assembly and hiding
of defects is allowed.
[0131] While the invention has been described in connection with
what are presently considered to be the most practical and
preferred embodiments, it is to be understood that the invention is
not to be limited to the disclosed embodiments, but on the
contrary, is intended to cover various modifications and equivalent
arrangements included within the spirit and scope of the invention.
Also, the various embodiments described above may be implemented in
conjunction with other embodiments, e.g., aspects of one embodiment
may be combined with aspects of another embodiment to realize yet
other embodiments. Further, each independent feature or component
of any given assembly may constitute an additional embodiment. In
addition, while the invention has particular application to
patients who suffer from sleep disordered breathing such as OSA, it
is to be appreciated that patients who suffer from other illnesses
(e.g., congestive heart failure, diabetes, morbid obesity, stroke,
bariatric surgery, etc.) can derive benefit from the above
teachings. Moreover, the above teachings have applicability with
patients and non-patients alike in non-medical applications.
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