Source: https://patents.google.com/patent/EP2213324B1/en
Timestamp: 2019-06-20 01:48:56
Document Index: 477038541

Matched Legal Cases: ['art 2', 'art 2', 'art 3', 'art 2', 'art 2', 'art 2', 'art 3', 'art 3', 'art 2', 'art 3', 'art 3', 'art 2', 'art 2', 'art 2', 'art 3', 'art 3', 'art 3', 'art 2', 'art 2', 'art 3', 'art 3', 'art 3', 'art 2', 'arts 2', 'art 2', 'art 3']

EP2213324B1 - Patient interface structure and method/tool for manufacturing same - Google Patents
EP2213324B1
EP2213324B1 EP09001344.2A EP09001344A EP2213324B1 EP 2213324 B1 EP2213324 B1 EP 2213324B1 EP 09001344 A EP09001344 A EP 09001344A EP 2213324 B1 EP2213324 B1 EP 2213324B1
EP09001344.2A
EP2213324A1 (en
2009-01-30 Application filed by ResMed R&D Germany GmbH filed Critical ResMed R&D Germany GmbH
2009-01-30 Priority to EP09001344.2A priority Critical patent/EP2213324B1/en
2010-08-04 Publication of EP2213324A1 publication Critical patent/EP2213324A1/en
2016-07-27 Publication of EP2213324B1 publication Critical patent/EP2213324B1/en
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 border 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.
WO-A-2008/106716 relates to a respiratory mask comprising a cushion 12 which may be integrally formed from silicone or foam by an injection-moulding process as well as a support structure 14 which may be made of nylone but could also be made of polypropylene or other suitable engineering material, wherein the support structure 14 may be formed by an injection moulding process. In a sample embodiment, the cushion 12 is said to be over-moulded onto the support structure 14.
It is an object underlying the present invention to provide a method for manufacturing a patient interface or a component of a patient interface, such as a cushion or pad a tool for manufacturing the same which overcome the deficiencies of the prior art.
Disclosed is 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.
Disclosed is also 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.
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.
According to a further alternative or additional aspect, the application discloses 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.
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.
According to an example, the component of a patient interface 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.
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.
Disclosed is also 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.
A disclosed component preferably forms an undercushion of a breathing mask cushion which is shielded or covered vis-à-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.
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. The 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. 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.
Preferably, as discussed above with regard to the patient interface or patient interface component as disclosed herein, 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.
In a preferred embodiment where at least one pressure flange is provided on the first molded 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.
Disclosed is 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.
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 material.
The structure of the component as disclosed 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.
As disclosed it may be possible 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.
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 viso-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.
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.
In accordance with an aspect as disclosed 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.
The patient interface as disclosed 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.
The configuration 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.
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.
The present invention is related to the following aspects.
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.
Method according to any one of the preceding aspects, wherein the first and/or second material comprises a color, preferably a differing color..
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.
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 1mm and more preferably of about 0,35mm.
Figures 6a to 6d show preferred embodiments of components according to the present invention wherein Figures 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 Figures 6c and 6d show further preferred embodiments of the component according to the present invention.
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.
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.
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.
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.
According to a further aspect, 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.
Figure 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.
Figure 6b shows the use of a component 1 according to the present invention similar to the embodiment discussed with regard to Figure 6a. As with the embodiment shown in Figure 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 Figure 6a, membrane 15 according to Figure 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.
Figure 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 Figure 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 Figure 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 Figure 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 Figure 7.
Extension 18 provides an additional advantageous possibility to apply a pressure rim (not shown in Figure 6c) to define merging surface 5h and to prevent foam or second foamed part 3 to extend beyond boundary point/line 19.
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 Figure 6c) and be build up or filled up to first molded part 2.
The preferred embodiment according to Figure 6d generally corresponds to the one discussed with regard to Figure 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.
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.
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 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. 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.
Method of producing a component (1) of a patient interface, comprising the following steps:
b) providing, preferably injecting, a first material into the first cavity in order to provide a first part (2) of the component;
d) providing a third mold (7) and a fourth mold part (9) adapted to define a second mold cavity between them;
f) providing a second foamed material into the second mold cavity in order to provide a foamed second part (3) integral with the first part,
wherein the third mold part and/or a fourth mold part are provided having at least one pressure rim structure (11; 11a, 11b) and wherein the pressure rim structure(s) is/are sealingly pressed against the first part for defining a merging surface (5; 5a, 5b) on the first part and for sealingly defining the second cavity and/or
wherein the 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 (2) comprises at least one pressure rim structure (11; 11a, 11b) molded by the negative pressure rim structure(s) of the first and/or second part.
Method of manufacturing a component (1) of a patient interface, particularly a cushion, according to claim 1 comprising the steps:
molding a first part (2) of the component (1) and foaming a second part (3) on the first part.
Method according to any one of the preceding claims, further comprising the steps:
handling the first part (2), the second part (3) and/or the component (1), wherein the first part constitutes and/or comprises the handling structure.
Method according to any one of the preceding claims, wherein the hardness of the first part (2) is higher than the hardness of the second part (3).
Method according to any one of the preceding claims, wherein first part (2) removed from the first mold part and the second mold part and inserted into a third mold part (7) and/or a fourth mold part (9), thereby defining, preferably in combination with the third mold part (7) and/or the fourth mold part (9), a second cavity for foaming on a second part on the first part.
Method according to any one of the preceding claims, 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 (11) which is/are sealingly pressed against the first part (2) for defining a merging surface on the first part and/or for sealingly defining a second cavity.
Tool for performing a method according to any one of claims 1 to 6, comprising first mold part, a second mold part, a third mold part (7) and a fourth mold part (9), wherein the first mold part and the second mold part are adapted to define a first cavity, wherein a first part (2) is moldable in the first cavity, and wherein the third mold part (7), the molded first part (2) and/or the fourth mold part (9) are adapted to define a second cavity, and wherein one or more pressure flange(s) (11) is are provided integrally with the third mold part (7), the fourth mold part (9) and/or the molded first part (2), and wherein second mold cavity is adapted to contain the first part and to be filled with a second foamed material.
Tool according to claim 7, wherein pressure-flange(s) (11) is/are adapted for sealingly contacting the third mold part (7), the first part (2) and/or the fourth mold part (9) such that the merging surface between the first part (2) and the second part (3) to be molded in the second cavity is defined by the pressure flange (11).
Tool according to any one of claims 7 or 8, wherein the third (7) and/or fourth (9) mold part comprise a sealing means, preferably an O-ring or sealing lip seated in a groove provided in the third (7) and/or fourth (9) mold part, wherein the merging surface (5; 5a, 5b) between the first part (2) and the second part (3) to be molded in the second cavity is defined by the sealing means.
EP09001344.2A 2009-01-30 2009-01-30 Patient interface structure and method/tool for manufacturing same Active EP2213324B1 (en)
EP09001344.2A EP2213324B1 (en) 2009-01-30 2009-01-30 Patient interface structure and method/tool for manufacturing same
US12/656,466 US20100192955A1 (en) 2009-01-30 2010-01-29 Patient interface structure and method/tool for manufacturing same
US15/945,532 US20180221612A1 (en) 2009-01-30 2018-04-04 Patient interface structure and method/tool for manufacturing same
EP2213324A1 EP2213324A1 (en) 2010-08-04
EP2213324B1 true EP2213324B1 (en) 2016-07-27
EP09001344.2A Active EP2213324B1 (en) 2009-01-30 2009-01-30 Patient interface structure and method/tool for manufacturing same
AU2016294431B2 (en) * 2015-07-14 2019-03-14 Qalo Llc Compression molded silicone ring
2009-01-30 EP EP09001344.2A patent/EP2213324B1/en active Active
2010-01-29 US US12/656,466 patent/US20100192955A1/en not_active Abandoned
2018-04-04 US US15/945,532 patent/US20180221612A1/en active Pending
US20180221612A1 (en) 2018-08-09
EP2213324A1 (en) 2010-08-04
US20100192955A1 (en) 2010-08-05
JP6456715B2 (en) 2019-01-23 Mask system
EP1910053B1 (en) 2016-04-27 Method for manufacturing a respiratory mask
CN1325034C (en) 2007-07-11 Improved baby products and methods for mfg. same
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