Source: https://patents.google.com/patent/EP1910053B1/en
Timestamp: 2018-06-20 16:28:48
Document Index: 500297401

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 11', 'arts 3']

EP1910053B1 - Method for manufacturing a respiratory mask - Google Patents
Method for manufacturing a respiratory mask Download PDF
EP1910053B1
EP1910053B1 EP20060760882 EP06760882A EP1910053B1 EP 1910053 B1 EP1910053 B1 EP 1910053B1 EP 20060760882 EP20060760882 EP 20060760882 EP 06760882 A EP06760882 A EP 06760882A EP 1910053 B1 EP1910053 B1 EP 1910053B1
EP20060760882
EP1910053A4 (en )
EP1910053A1 (en )
It should be noted that the phrase "respiratory mask" in this specification includes any type of patient interface, including full face masks, nasal masks, and nasal prong masks etc.
International Patent Application PCT/EP02/11798 , filed by Medizintechnik fur Arzt und Patient (MAP), now ResMed Germany, discloses a respiratory mask for administering a breathable gas to a user. This respiratory mask makes it possible, when worn by a user, to seal off an interior volume of the respiratory mask from the environment. Such respiratory masks are used particularly in conjunction with medical or therapeutic administration of breathable gases (and additions thereto, such as drug vapours), as well as in the industrial field, for instance in the field of gas masks and breathing equipment. Typically, the interior volume is sealed using a sealing cushion or lip structure that is inwardly curved and extends around an opening in the mask and seals against the user's face. Sealing cushions are generally made from an elastically deformable material, such as silicone and seal by compression against the user's face. The level of sealing achieved generally increases with the contact pressure of the sealing cushion against the face.
It is known that good mask aesthetics can be achieved by a sleek, simple design that does not have a 'busy' appearance. However, the various functional requirements of masks sometimes impinges on a designers ability to design a mask with good aesthetics. This problem can be compounded when masks are made from a relatively large number of components that do not connect in a smooth, contoured fashion.
Document US 2003/0075180 relates to a respiratory mask assembly for use in the delivery of non-invasive positive airway pressure to a user. The assembly includes a rigid shell having a channel portion defined by an inner wall, an outer wall and a channel floor, a face-contacting cushion acting to space the shell away from the user's face and a sealing tab extending from the cushion to engage a portion of the shell to provide a continuous airtight seal between the cushion and the shell.
Document US 2002/0100479 A1 relates to a seal with a first portion defined by a gel substance and a second portion associated with the first portion.
BRIEF SUMMARY OF THE INVENTION 3.0 Embodiments of The Present Invention
According to the invention, there is provided a method for manufacturing a respiratory mask as defined in claim 1, the method comprising: providing an elastomeric material for forming into a first component; providing a second component that is less flexible than the elastomeric material in a mould; and integrally forming the elastomeric material onto the second component within the mould in order to form the first component.
The first component can be manually separated from the second component, and at the same time the first component is joined to the second component in an intimately adhering manner. The method further comprises pre-treating the second component to strengthen adhesion between the first and second components. The pre-treating step may comprise applying plasma, preferably an atmospheric gas plasma, to a bonding surface of the second component. Corona treatment is an alternative. The integral forming may be carried out in an injection moulding tool.
In one example, there is described a method for manufacturing a respiratory mask wherein at least one step in the manufacturing process is the integral forming of at least two components in or from at least two different materials. Another aspect of the invention relates to a respiratory mask manufactured by the above method.
Preferably, the integral forming is an overmoulding operation which is automated, for example, by using robotics. Overmoulding may be performed by any known moulding technique, including surface treatment by any known treatment, such as plasma treatment. An overmoulding step may be used to mould a flexible component onto a component that is less flexible than the flexible material (henceforth a "substantially rigid component"). In one example, the mask cushion (e.g., silicone) and frame (e.g., polycarbonate) are co-moulded using one of the manufacturing processes described herein.
In an aspect, the integral forming of a flexible component onto a substantially rigid component is done directly in an injection moulding tool. This injection moulding tool preferably includes multiple cavities.
A liquid silicone rubber (LSR) material is preferably used for the flexible material and a polycarbonate plastic is preferably used for the substantially rigid material. In an example, the integral forming of the components is carried out in such a way that the flexible component can be manually separated from the substantially rigid component. This allows the flexible component to be removed as required. It is also possible to accomplish the integral forming such that the flexible component is coupled with the substantially rigid component in an intimately adhering way (i.e. the components cannot be manually separated).
In an aspect at least one of the flexible components of the respiratory mask is a sealing cushion. The sealing cushion is preferably integrally formed onto the substantially rigid component in such a way that an intimate adhesive bond results. The bonding geometries of the substantially rigid component and the flexible components as well as other factors may be manipulated to provide a required level of adhesion.
According to another aspect, there is provided a respiratory mask for administering a breathable gas to a patient, the respiratory mask comprising a) a first component formed from an elastomeric material; and b) a second component formed from a material that is less flexible than the elastomeric material, wherein the first component is integrally formed onto the second component.
In another example, there is provided a respiratory mask comprising a substrate made of a relatively rigid material, wherein the substrate includes at least one treated portion inclined to accept a reactive substance; and an elastomer that is made of a relatively more flexible material compared to the relatively rigid material of the substrate, said elastomer being applied to the substrate and secured to the substrate via an induced adhesive bond formed between said treated portion and a surface of the elastomer abutting the treated portion.
According to yet another example, there is provided a mould for a respiratory mask for administering a breathable gas to a patient, the respiratory mask comprising a first component formed from an elastomeric material; and a second component formed from a material that is less flexible than the elastomeric material, wherein the first component is integrally formed onto the second component, wherein the mould comprises a mould cavity in which the first component is moulded onto the second component.
According to an aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomers to or with the substrate, wherein the mask includes a mask frame and an elbow provided to the frame, and wherein the elbow or frame includes at least one selected portion including said substrate, and the method further comprises overmoulding said elastomer onto the selected portion.
According to another example there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame, a cushion provided to the frame and a forehead support positioned above the frame, wherein the mask comprises a flexible portion coupling the frame and the forehead support, the flexible portion including a structural member including said substrate and at least one disc or tube including said elastomer.
According to yet another example, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame made at least in part from said elastomer and a retaining ring including said substrate, wherein the method further includes overmoulding the frame onto the ring.
According to another aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask comprises a frame and a cushion and a headgear assembly to support the frame and cushion, wherein the headgear assembly includes a yoke associated with a strap and a seal ring provided to the yoke, wherein the yoke includes at least one selected portion including the substrate and the method comprises co-moulding the seal ring onto the yoke.
According to another aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a frame and a gas washout vent having at least one hole or pore, wherein the frame includes at least one selected portion including the substrate and the method comprises co-moulding the gas washout vent onto the frame.
In an example, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a frame having an aperture and a plug provided to close the aperture, the frame including at least a selected portion including said substrate and the method comprise overmoulding the plug onto the frame.
According to another example there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a conduit including said substrate and a wall member formed at least in part by said elastomer, and said method further comprises overmoulding the wall member and the reinforcement member.
According to another aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the frame includes a port portion and a port cap provided to the frame, wherein the port portion includes at least a selected portion including the substrate and the method further comprises overmoulding the port cap onto the frame.
In a further aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein said mask includes a frame with said substrate and a bladder is provided to the frame and formed at least in part from said elastomer.
Still in a further aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a frame including at least one port, and nasal cannulae, wherein the frame includes said substrate and the cannulae are formed at least in part from the elastomer, the cannulae being in communication with the port.
According to another example, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a frame, a cushion, a forehead support positioned above the frame, and a forehead pad provided to the forehead support, the forehead pad including said elastomer and the forehead support including said substrate.
According to another aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame including the substrate and a mask cushion including the elastomer, wherein the frame includes a peripheral region and the cushion includes a T-shaped or L-shaped rim overmoulded to the frame
According to another example, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame including the substrate and a mask cushion including the elastomer, in which the mask frame and the mask cushion form at least one of a diagonal joint, a lap joint and/or a V-joint.
According to yet another example, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a frame and a cushion, the cushion having an expandable bladder having an interior defined by an interior surface of the elastomer and a portion of the frame that is not treated, and the frame includes a port to allow introduction of a substance delivered to the interior to expand the bladder.
In a further aspect, there is provided a method for manufacturing a respiratory mask comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame a cushion and a cushion clip to secure the cushion to the frame, wherein the substrate is provided as part of the cushion clip and the cushion includes the elastomer.
According to another aspect, there is provided a humidifier tub for a flow generator comprising a substrate made of a relatively rigid material, wherein the substrate includes at least one treated portion inclined to accept a reactive substance; and an elastomer that is made of a relatively more flexible material compared to the relatively rigid material of the substrate, said elastomer being applied to the substrate and secured to the substrate via an induced adhesive bond formed between said treated portion and a surface of the elastomer abutting the treated portion wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer.
According to yet another example, there is provided a method for manufacturing a humidifier tub comprising forming a substrate made of a relatively rigid material; and overmoulding an elastomer to or with the substrate, wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer.
According to another aspect, there is provided a humidifier tub comprising a substrate made of a relatively rigid material; and an elastomer overmoulded with or to the substrate, wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer. Furthermore, there are provided the following aspects which are numbered starting from 35:
Fig. 1 is a side, partial cross-sectional view of a respiratory mask shown in situ on a patient's face;
Fig. 2 is a cross-sectional perspective view of a respiratory mask ;
Fig. 3 is a cross-sectional perspective view of an enlarged portion of the frame/ cushion interface of the respiratory mask of Fig. 2 and illustrates the bonding configuration therebetween;
Fig. 6 is a schematic, side, cross-sectional view of a cushion to frame connection;
Fig. 8 is a side, partial cross-sectional view of the respiratory mask of Fig. 1 and illustrates a flexible portion between the frame and forehead upport;
Fig. 9 is a side, partial cross-sectional view of a respiratory mask and illustrates a flexible portion that incorporates a conduit section therethrough;
Fix. 10 is a perspective exploded view of a respiratory mask frame, elbow and elbow retaining clip
illustrating a bonded elastomer sealing portion on the elbow;
Fig. 11 is a perspective exploded view of a respiratory mask frame, elbow and elbow retaining clip
illustrating a number of additional bonded elastomer sealing portions on the socket and retaining clip;
Fig. 12 is a perspective exploded view of an elbow of a respiratory mask illustrating a number of bonded elastomer sealing portions;
Fig. 13 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig. 16 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig. 20 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig. 23 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig. 26 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig.27 is a perspective, cross-sectional view of the portion of the frame and elbow of Fig. 26;
Fig. 29 is a perspective view of a portion of a respiratory mask frame and elbow;
Fig. 32 is a perspective, exploded view of an elbow and a frame having a flexible enclosure, a rigid elbow connection ring defining an aperture in the frame and a rigid surrounding portion;
Fig. 33 is a perspective, exploded view of an elbow, frame and headgear member;
Fig. 34 is a side, partial cross-sectional view of a respiratory mask and illustrates a vent;
Fig. 35 is a perspective exploded view of a respiratory mask frame and vent plug;
Figs. 36(a)-36(d) are schematic diagrams showing three types of conduit reinforcing structure;
Fig. 37 is a side, cross-sectional view of a ports cap configured on a frame of a respiratory mask;
Fig. 38 is a perspective, exploded view of a frame, elbow and elbow retaining clip including a plurality of gripping portions;
Fig. 39 is a perspective view of a frame including a large gripping portion;
Fig. 40 is a perspective view of a frame including a detachable conduit; arrangement
Fig. 41 is a perspective view of a flow generator including a humidifier tub having a lid;
Fig. 44 is a non-vented full face mask;
Fig. 48 is a perspective view of an elbow having elastomer seal;
Fig. 49 is an exploded perspective view of a test ring having a seal for insertion within a receptacle;
Figs. 50-53 illustrate partial cross-sectional views of plug seals; and
Fig. 54 illustrates a schematic diagram of a mould system.
DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS OF THE INVENTION 5.0 Introduction 5.0.1 Definitions 5.0.1.1 "Overmoulding"
The word "overmoulding" is used in this specification in its broadest sense, that is, in the sense of moulding one component onto another component, or integrally forming two components. A number of different moulding processes that are deemed to fall within the ambit of the word 'overmoulding' as used in this specification are described below. It should be appreciated that this group of moulding processes is inclusive and not exhaustive.
Overmoulding is used to refer to the process of forming a bond between a first material, known as the "substrate material", and a second material known as the "overmould". However, the word 'overmoulding' also refers to moulding where no bond or substantive bond is formed but where respective components are held together, for example, only by a mechanical interlocking, keying or undercut. Mechanical interlocking can be either macroscopic (e.g., undercuts) or microscopic (e.g., depending on abrasion of the substrate).
The word 'overmoulding' also refers to a type of moulding where the two materials to be joined are inserted into the mould at the same time or at two points in time close together. For example, overmoulding includes "overmoulding" or "co-injection moulding". A co-injection moulding process involves a first step where a first component (e.g., substrate) is moulded in a first mould and once ejected progresses to a second step where the first component is placed inside a second mould for the moulding of a second component (e.g., elastomer) on to it. In between the moulding steps, the first component may be treated to more readily accept a reactive substance. Treatment may take the form of plasma treatment, for example, and this treatment may take place within the mould(s) or outside the moulds. What distinguishes co-injection moulding from other types of overmoulding is that when the first component is being progressed through the second step another first component is being manufactured by the first step. That is, the first and second steps are being performed simultaneously for sequentially manufactured products. This can be achieved with a rotating tool set (e.g., a turntable with two or more moulding stations) or robotic arm.
'Overmoulding' also refers to "Moving Cores Moulding" where one injection moulding machine fitted with two injection systems is used. Once the substrate has cooled sufficiently a section of the tool retracts, forming a cavity for the overmould material. Moving cores have conventionally been best suited to simple overmoulds, where a uniform thickness of overmould is required.
"Rotating Platen or Stripper Plate" moulding is also considered a overmoulding process. This process involves rotation of the tool once the substrate has cooled. A rotating platen rotates the component on its core, whereas a rotating stripper plate lifts the component off its core before rotating. The main advantage of these methods is that they allow a different shaped cavity or core to be used to form the overmould. More sophisticated components can be created using this method.
The words "flexible material/component" as used in this specification include any material with physical properties similar to or the same as an elastomer material which is defined in the Webster's New World Dictionary as, "a rubber-like synthetic polymer, as silicone rubber". Therefore, a rubber, a natural polymer or any other rubber-like material including some gels are included within the scope of the words "flexible material/component".
The words "flexible material/component" also refer to various mixtures of individual elastomer components. These elastomers may be pre-mixed or mixed in the mould. Examples of elastomers are liquid silicone rubber (LSR), solid silicone rubber and thermoplastic elastomers (TPEs).
A substantially rigid component includes all materials that are less flexible than the flexible material. Examples of substantially rigid components are polycarbonate (e.g. Lexan) and phenol formaldehyde (e.g.Bakelite.)
One such pretreatment is the application of plasma, such as an atmospheric gas plasma, to the bonding area of the substrate. Plasma treatment chemically activates the bonding area to enhance chemical bonding. Plasma treatment is effected by blasting highly energized gases at the surface which causes reactive molecules to be embedded in the surface. These molecules form a bond with the relatively less rigid component, e.g., in the case of silicone, a polydimethyl siloxane bond may be formed. The gas is typically compressed air, but it can be nitrogen or other gases. It should be noted that the longer a plasma treated surface is left before bonding, the less effective the treatment will be. Plasma treatment is described in "Plasma Processes and Polymers" by d'Agostino et al., published by Wiley, 2005.
Examples of commercially available atmospheric gas plasma guns include Atomflo™ by Surfx Technologies LLC of USA and PlasmaTEC™ by Dyne Technology Ltd of UK.
Adhesion strength is also dependant on timing. A better bond may be formed when the second component is moulded onto the first component if the temperature of the first component is still raised. In the case that a chemical bond is not required, temperature differences and the resulting shrinkage differential may improve mechanical interlocking.
A respiratory mask 2A is shown in Fig.1 1 in situ on the face of a user 1000. The mask 2A comprises a frame 4A, formed from a substantially rigid component, such as a polycarbonate material, a sealing cushion 6A formed from an elastomeric material, such as liquid silicone rubber (LSR), and a forehead support 8A, which is adjustably coupled to the frame 4A via a flexible portion 10A. The forehead support 8A includes a forehead pad 12A, made from an elastomeric material.
Various bond configurations are possible. In one example shown in Figs 2 and 3, the cushion 6B of a respiratory mask 2B has a T-shaped rim 20B that is sized to be bonded to a peripheral region 22B of the frame 4B. The T-shaped rim 20B provides a bonding surface 24B that is larger than it would otherwise be if no T-shaped bonding rim 20B was provided. This larger bonding surface 24B allows a stronger bond to form. Alternatively, an L-shaped bonding rim could be provided. However, the T-shaped bonding rim 20B is advantageous with respect to the L-shaped rim because when the cushion 6B is pulled away from the frame 4B, no bending moment is created. A bending moment could assist a tear developing through the bond. Other suitable bonding configurations include a diagonal joint, a lap joint and a V-joint. Furthermore, the bonding could occur on an interior surface of frame 4B, e.g., a lap joint.
Referring to Figs 4 and 5, selective bonding can be utilized to form a bladder 26B that can be expanded. The bladder 26B can be expanded by delivery of pressurized air to a port 30B. The stenciling or masking procedure described in Section 5.0.2 may be utilized to chemically activate bonding areas 32B where sides of the wall 34B of the bladder 26B join the frame 4B. The bonding areas 32B adhere to the portions of the cushion in contact with the bonding areas, while the surface of the bladder 26B is free to separate from the frame 4B since those portions of the frame have not been treated. The pressurized air may be pressurized to 2 bar or any other suitable pressure. Furthermore, gases other than normal air could be used to pressurize the bladder 26B. Alternatively, a gel, foam, liquid or other soft substance may be inserted into the bladder 26B instead of a gas, such that a soft, flexible pad is formed. The pad maybe filled and permanently sealed or be releasably or temporarily sealed. The inside surfaces of the pad may be provided with a permetion-resistant liner.
In one example, the gel cushion could be provided using a skin made of LSR that is filled with a gel, e.g., silicone. To prevent the gel from permeating through the LSR skin, the inside surface of the skin could be coated with a liner, such as polyester and/or polyurethane. The liner could be applied using any number of techniques, e.g., spraying (just before the gel is introduced, e.g., in Fig. 5), co-moulding, dipping, brushing, etc.
Referring to Fig 6, an alternative reinforced bladder arrangement 36C is shown. In this arrangement the cushion 6C is not directly formed onto the frame 4C but is co-moulded to a clip 38C. The clip 38C is attachable to the frame 4C by a mechanical interlock. The cushion 6C may also be bonded to the clip 38C in a manner such that when attached to the frame 4C, a portion of the cushion 6C is sandwiched between the frame 4C and clip 38C providing a mechanical interlock. The clip 38C is configured with a reinforcing member 40C for supporting and stabilizing an under surface 42C of the cushion 6C. This limits rotation/ movement of the cushion 6C on the face of the user.
Referring now to Fig 7, the forehead support 8A and forehead pad 12A may be embodied as co-moulded components. The forehead pad 12A is formed by injection-moulding an elastomeric material onto the forehead support 8A which is made from a dimensionally stable plastic material, such as a polycarbonate. A slot 44A is formed in the forehead pad 12A during the overmoulding process by virtue of the shape of the forehead support 8A. The slot 44A provides a mechanical interlock such that the forehead support 8A can be releasably secured to the forehead support 8A. There is no intended or significant adhesive bond between the forehead support 8A and forehead pad 12A in this embodiment. This may be achieved by not using a surface pre-treatment and/or overmoulding the parts once the forehead support 8A is completely set (i.e. after moulding). The benefit of not including a substantive bond in this instance is that the forehead support can be removed for separate cleaning or replaced with a new or different type of forehead support.
The flexible portion 10A will now be described with reference to Fig 8. The flexible portion 10A comprises a structural spine 50A and a number of elastomer discs 52A that have been co-moulded onto the spine 50A and between the frame 4A and the spine 50A. Because the elastomer discs 52A are flexible, the frame 4A is able to articulate with respect to the forehead support 8A. The elastomer discs 52A may be made from the same elastomer material that the cushion 6A is made out of or from a different flexible material. In an alternative example the elastomer discs 52A comprise bladders formed from an elastomeric material (or otherwise) that are filled with a compressed gas, liquid or soft solid such as foam, gel or mineral particles.
Fig 9 shows another example of a mask 2D having a flexible portion 10D including an elastomer tube 56D around which a less flexible exoskeleton 58D is disposed. The ends 60D & 62D of the elastomer tube 56D have been comoulded to the frame 4D and forehead support 8D, respectively. This arrangement allows the frame 4D to articulate with respect to the forehead support 8D, and consequently, the cushion 6D to rotate and move to a degree with respect to the patient's face. This means that the mask 2D is able to provide a better seal against the patient's face. This elastic deformation behavior can be varied by changing the wall thickness or wall section of the exoskeleton 58D.
A mask in accordance with other examples may include a translatable adjustment rather than a rotatable adjustment.
Referring to Fig 10, a mask 2E is shown which has a frame 4E that comprises a socket 68E that is adapted to receive a first end 70E of an elbow 72E. The first end 70E of the elbow 72E is swivel mounted to the socket 68E and the elbow 72E provides fluid communication between a conduit (not shown) and the mask 2E. A clip 74E is provided to the first end 70E of the elbow 72E to retain it in the socket 68E in use.
In Fig 10 the second end 76E of the elbow 72E has an elastomer portion 76E co-moulded thereto to provide an improved connection and seal with the conduit to which it is attached. In an altemative (not shown), the conduit has an elastomer sealing portion rather than the second end 76E.
Referring to Fig 11 the socket 68G has a dimensionally rigid material portion 78G and an elastomer portion 80G co-moulded onto an inner surface thereof. The elastomer portion 80G provides a better seal with the first end 70G of the elbow 72G in use. The clip 74G also includes an elastomer portion 88G co-moulded thereon. This provides a more acoustically pleasing clipping sound.
Fig. 12 illustrates an elbow 72H generally similar in design and construction to the elbow of Figs 10 & 11 in its component parts. The elbow 72H features a number of elastomer portions 90H that serve to aid sealing, dampening, the reduction of rattle and/or the tactility and acoustics of connecting parts.
A number of different elbow-to-frame sealing arrangements will now be described. These are suitable for use on a variety of masks. Following this a sealing elbow arrangement for the ResMed Meridian mask [ U.S. Provisional Patent Application No. 60/682827 ] and a sealing arrangement for the ResMed Swift mask [ U.S. Provisional Patent Application No. 60/734282 ] will be described.
Figs. 13 to 15 show a two stage radial seal 92I comoulded to an elbow 721 and adapted to seal against a frame 4I. The seal 92I comprises a long elastomer lip 94I that abuts an inner surface 84I of a socket 68I of a frame 4I. The seal 92I further comprises two shorter lips 96I that are moulded in the line of draw. In use, the long lip 94I presses into the socket 68I and flexes back onto the two shorter lips 96I such that the long lip 94I is supported in a position where it abuts and seals against the socket 68I. This geometry accommodates misalignment of the elbow 72I with respect to the frame 4I.
The elbow 72I further incorporates three circumferential flanges. A first flange 98I is integrally moulded to the elbow 721 to prevent the seal 92I from contacting any flat supporting surface when the elbow 721 is disassembled from the frame 4I. This minimises risk of damage to the seal 921 during transport, storage and cleaning. A second flange 100I is provided on the elbow 72I and engages the socket 68I to stabilize the elbow 68I. While in this embodiment the second flange 100I is located inboard from the seal 92I, in other embodiments it could be moved outboard providing a greater moment arm. A third flange 102I is positioned within the socket 68I to engage a shoulder 1031 of the elbow 41, adjacent where the socket 681 begins to extend beyond the outer surface 104I of the frame 4I.
Optionally, only a line contact seal is provided to the frame 4I as opposed to an area contact seal. A line contact seal reduces the torque required to rotate the elbow with respect to the frame.
The example shown in Figs 16 to 19 includes a seal 106J that is similar to the seal 921 of Figs 13-15 except that the seal geometry has been altered to provide less contact area between the seal 106J and the frame 4J. The seal 106J comprises a long elastomer lip 94J and one shorter lip 96J that are moulded in the line of draw. The long lip 94J presses into the socket 68J of the frame 4J and flexes back onto the shorter lip 96J such that the long lip 94J is supported in a position abutting and sealing with the inner surface 84J of the socket 68J. This geometry accommodates misalignment of the elbow 72J with respect to the frame 4J.
The elbow 72J incorporates three circumferential flanges to stabilize the elbow 72J within the socket 68J. A first flange 98J is positioned outside the socket 68J and frame 4J. The first flange 98J prevents the seal 106J from contacting any flat surface when the elbow 72J is disassembled from the frame 4J thereby reducing the risk of damage to the seal 106J during transport, storage and cleaning. A second flange 100J is positioned outside the socket 68J and inside the frame 4J and abuts the socket 68J to stabilize the elbow 68J. A third flange 102J is positioned within the socket 68J adjacent where the socket 68J begins to extend beyond the outer surface 104J of the frame 4J.
In another example, only a line contact seal is provided to the frame 4J as opposed to an area contact seal. A line contact seal reduces the torque required to rotate the elbow with respect to the frame.
This design avoids undercuts and crevices to ensure ease of cleaning.
Referring to the mask 2K of Figs 20-22 an elbow 72K is provided having a single radial lip seal 108K that acts on an inner surface 84K of a socket 68K. The elbow 72K incorporates four circumferential flanges to support and stabilize the elbow 72K on the frame 4K. A first flange 98K is positioned outside the socket 68K and frame 4K. A second flange 100K is positioned outside the socket 68K and inside the frame 4K. A third and fourth flange, 102K & 110K respectively, are positioned on either side of the seal 108K. This design avoids undercuts and crevices to ensure ease of cleaning.
Figs 23 to 25 show a mask 2L incorporating a double radial seal 112L. The double radial seal 112L has two lips 114L & 116L, respectively, adjacent each other, that seal against an inner surface 84L of a socket 68L of a frame 4L. Each lip 114L, 116L is configured with a generally triangular cross-section such that it has a degree of stiffness to enhance sealing.
The elbow 72L incorporates three circumferential flanges 98L, 100L & 102L that are arranged in the same fashion as the embodiment of Section 5.5.1 and Figures 13-15. This design avoids undercuts and crevices to ensure ease of cleaning.
The example shown in Figs 26-28 provides 3 sealing zones between the elbow 72M and the socket 68M. The 3 sealing zones include a radial seal 114M disposed on the elbow 72M inside the socket 68M, an axial seal 116M that seals against an end face 118M of the socket 68M and an external radial lip seal 120M that seals against an outside the socket 68M.
Referring to Figs 29-31 a sealing arrangement 122N is shown. The sealing arrangement 122N comprises a radial lip seal 124N of triangular cross-section that seals against an inner surface 84N of the socket 68N and an axial lip seal 126N that seals against an end face 118N of the socket 68N.
The elbow incorporates the same arrangement of three circumferential flanges for stabilization of the elbow 72N within the socket 68N as is provided in the embodiment of Figs 13-15 described in Section 5.5.1.
5.5.7 ResMed Meridian Mask [US Patent Application No. 60/682827]
Referring to Fig 32, the ResMed Meridian Mask Assembly 20 comprises a flexible silicone frame 40 having a hard peripheral portion 1270, a polycarbonate elbow 720 and a retaining ring 1280 that is used to connect the frame 40 to the elbow 720 and allow them to swivel relative to each other.
The elastomer frame 40 can be overmoulded to the retaining ring 1280. This ameliorates any difficulties encountered in mounting the ring 1280 on the frame 40 and takes away the step of connecting the two parts during assembly.
5.5.8 ResMed Swift Mask Elbow [US Patent Application No. 60/758200]
Referring to Figure 33, a portion of a ResMed Swift Mask 2P is shown including a cushion assembly 6P, yoke 130P that is attached to a headgear strap, seal 132P and elbow 72P. The yoke 130P includes a yoke ring 134P that is adapted to surround a portion of the seal 132P and the seal 132P is adapted to surround a portion of the elbow 72P. The cushion assembly 6P may be adjustably rotated with respect to the yoke 130P.
Referring to Fig 34, the frame 4P includes a co-moulded vent 54P for allowing exhaled breath to exit an interior region of the frame 4P into the surrounding environment. The vent 54P is formed from an elastomer material that has been co-moulded to the frame 4P. The geometry of the frame 4P and vent 54P are such that they mechanically engage in a manner that allows the vent 54P to be retained or removed from the frame 4P, as required.
In another example, the vent 54P is substantially inseparably coupled to the frame 4P by a chemical bond in addition to the mechanical interlock. The vent may also be embodied as an insert that comprises a plurality of fluid conduits (or vent holes or pores (e.g., sintering)) that connect the interior region of the frame 4P to the surrounding environment.
Fig 35 depicts a vented mask 2Q having a vent aperture 54Q and a plug 136Q. For ease of visualization Fig 35 shows the plug 136Q separately from the mask 2Q but in reality the plug 136Q is formed in the vent 54Q by overmoulding to form a non-vented mask. In this case, the plug 136Q is formed from silicone.
In one example, the conduit structure is configured as a reinforcement structure, e.g., an exoskeleton over/within, and/or inside the flexible conduit wall. Clearly, where the conduit structure extends continuously along the conduit wall, the conduit structure must be formed of a flexible material to allow the conduit to bend. Fastening of the flexible wall to the conduit structure may be achieved by either mechanical engagement, molecular bonding or both.
Three examples of conduit structures are shown in Figs. 36(a)-36(c). The first, shown in Fig 36(a), is a helical conduit structure 140S that provides significant torsional strength. The second conduit structure 140T, shown in Fig 36(b), comprises a plurality of circular ribs 142T interconnected by longitudinal members 144T that are provided on alternating opposing sides of the conduit wall (not shown). Fig 36(c) depicts a third conduit structure 140U comprising a plurality of circular ribs 142U interconnected by dual longitudinal members 144U that are provided on opposing sides of the conduit wall (not shown). Fig 36(d) depicts a fourth conduit structure 145.
5.9 Mask Surfaces 5.9.1 Gripping
An example of how gripping regions might be incorporated into a mask frame 4W and elbow 72W is illustrated in Fig 38. A number of small gripping regions 152W are co-moulded onto each side of the frame 4W and at least one relatively large gripping region 154W is co-moulded onto each side of the elbow 72W. The elbow gripping regions 72W assist: (1) gripping of the elbow 72W during manufacture, and/or (2) removal of the elbow 72W from the frame 4W by a patient or clinician.
5.9.2 Soft Touch.
Other mask examples include one or more soft touch surface(s) co-moulded to the mask frame. The soft touch surface(s) feels nicer and less clinical to a patient than a hard surface(s) (e.g. polycarbonate). By varying the thickness and hardness of a soft touch surface, a range of different feels may be provided. Other parts of respiratory masks may also include soft touch surfaces such as the headgear clips or forehead support
Co-moulded elastomer regions also provide suitable surfaces for the placement of product or company branding or logos, e.g., "ResMed" could be spelled out by co-moulding onto various mask components such as the frame, headgear, forehead support, elbow, etc. In one embodiment, the branding indicia is embossed into the elastomer or the elastomer forms the branding indicia. It should be noted that any one elastomer region could be used for a multiplicity of purposes, such as more than one of gripping, soft touch and branding. The elastomer could also be coloured to improve aesthetics, or for branding purposes etc.
5.10 Other Overmoulding Applications for Masks 5.10.1 Mask Volume Reduction Bladder
Referring to Fig 39, a mask volume reduction bladder (MVRB) 156Y may be incorporated into a mask frame 4Y by overmoulding an expandable pocket onto an interior surface 158Y of the frame 4Y, and more particularly, overmoulding a peripheral edge 160Y of the pocket to the interior surface 158Y of the frame 4Y. The bladder 156Y is positioned and configured such that it is expandable to occupy at least a portion of the gas dead space within the mask. In this particular example, the bladder walls are made from a thin sheet of silicone (0.1 - 0.6 mm thick).
In another variation the bladder inflates and deflates responsive to the breathing cycle of the patient, reducing the volume required to be displaced by the patient's lungs during exhalation. In yet another embodiment, the bladder deflates during exhalation to increase the volume and thus reduce the expiration pressure peak and subsequently the work of breathing. In another example the bladder is co-moulded to an outer surface of the frame and an interior portion of the bladder is in fluid communication with an inner region of the frame (e.g. via an aperture in the frame). During exhalation the bladder can expand and thus reduce the expiration pressure peak and subsequently the work of breathing.
Fig 40 shows a frame 4Z of a respiratory mask incorporating oxygen cannulae 162Z that are formed by overmoulding silicone to an interior surface of the frame 4Z. The cannulae 162Z can be peeled away from the frame 4Z starting at the cannula exit apertures 164Z such that the exit apertures 164Z are positioned directly beneath a patient's nares. The cannulae 162Z are in fluid communication with frame ports 166Z to which an oxygen delivery conduit (not shown) or gas receiving conduit (not shown) may be attached. A gas receiving conduit might be used to receive exhaled breath in order to detect levels of different gases (e.g. oxygen) in the exhaled breath. The frame ports 1-66Z are sealed by plugs when the cannulae 162Z are not in use and the cannulae 162Z may be completely removed (torn off) the frame 4Z. The plugs may take the same or similar form to those described in Section 5.8.
5.10.3 Humidifier Tub Seal [US Patent Application No. US 10/533940]
Referring to Figs 41-43, a ResMed S8 flow generator 168AA is shown comprising a humidifier 170AA. The humidifier 170AA has a lid 172AA, an underside of which is shown in Fig 42 and includes a recess 174AA. Fig 43 shows an elastomer seal 176AA that is adapted to fit in the recess 174AA.
The improvement over US Patent Application No. US 10/533940 is that the elastomer seal 176AA is co-moulded to the lid 172AA about the air exit aperture 178AA. This overmoulding provides a stronger mounting of the seal 176AA to the lid 172AA than a mere mechanical interlock and also ameliorates the problem of biological growth in crevices. The overmoulding can be in the form of a full surface bond or a peripheral bond.
Fig. 44 shows a full face mask 2.1 having a frame 2.2 and an elbow 2.3 provided to the frame. Details of the overall mask are described in relation to U.S. Patent Application No. 11/027,689, filed January 3, 2005 . A seal is formed between the elbow and the frame and may be formed on the frame or the elbow using the overmoulding techniques described herein.
A mould for a respiratory mask or humidifier tub is provided in one example. The substantially rigid component mould provides the substantially rigid component with very small sealing rims around the periphery of the elastomer bonding region and the elastomer mould has corresponding notches that form a tortuous path that is difficult for the liquid elastomer or other material to flow through. Fig. 54 shows a sample rotating mould system 4.1 having a turntable 4.2 that rotates about an axis 4.3. Turntable 4.2 includes a first moulding station 4.4 for moulding a first component, e.g., the substrate (e.g., frame) and a second moulding station 4.5 for moulding a second component, e.g., the elastomer (e.g., cushion, pad, seal, etc.).
An automated manufacturing process for a mask is further described. The automated manufacturing process utilizes overmoulding to manufacture and/or bond appropriate components, in combination with at least one automated assembly step (e.g. fitting the elbow in the socket or attaching the headgear to the headgear clips).
Biocompatibility (specifically- ISO 10993, parts 3, 5, 6, 10 &11)
"Dynaflex® TPE Compounds" and "Versalloy®" made by GLS
"Santoprene™ Thermoplastic Vulcanizate" and "Santoprene™ Thermoplastic Vulcanizate" made by Advanced Elastomer Systems.
Silastic ™ Silicone rubbers made by Dow Coming.
Elastosil ™ Silicone rubbers made by Wacker.
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 as defined in the appened claims. For example, any functionally suitable materials may be utilized in conjunction with this invention. Furthermore, the flexible and substantially rigid materials could have the same level of flexibility or resilience. Optionnally, the substantially rigid material could be more flexible than the flexible material.
an elastomer that is made of a relatively more flexible material compared to the relatively rigid material of the substrate, said elastomer being applied to the substrate and secured to the substrate via an induced adhesive bond formed between said treated portion and a surface of the elastomer abutting the treated portion.
36. The respiratory mask according to aspect 35, wherein the mask includes a mask frame and an elbow provided to the frame, wherein the elbow includes at least one selected portion including said substrate and said elastomer is provided to the selected portion.
37. The respiratory mask according to aspect 36, wherein the elbow includes a plurality of components and the selected portion includes the interface between any two elbow components.
38. The respiratory mask according to aspect 35, wherein the mask includes a mask frame and an elbow provided to the frame, wherein the frame includes a socket defining said substrate and the elastomer is provided to said socket.
39. The respiratory mask according to aspect 35, wherein the mask includes a mask frame, a cushion provided to the frame and a forehead support positioned above the frame.
40. The respiratory mask according to aspect 39, further comprising a flexible portion coupling the frame and the forehead support, the flexible portion including a structural spine including said substrate and at least one disc including said elastomer.
41. The respiratory mask according to aspect 39, further comprising a flexible portion coupling the frame and the forehead support, the flexible portion including an exoskeleton including said substrate and a tube including said elastomer.
42. The respiratory mask according to aspect 41, wherein the tube has first and second ends that are co-moulded to the frame and the forehead support, respectively.
43. The respiratory mask according to aspect 36, wherein the elastomer is in the form of a seal.
44. The respiratory mask according to aspect 43, wherein the seal includes a relatively long elastomer lip flexibly positionable and bendable against and adjacent a socket of the frame, and at least one relatively shorter lip positioned between the relatively long elastomer lip and an outer circumference of the elbow in use.
45. The respiratory mask according to aspect 43, wherein the seal includes at least one relatively shorter lip extending radially between the elbow and the socket of the frame.
46. The respiratory mask according to any one of aspects 44-45, wherein the at least one relatively shorter lip includes two lips.
47. The respiratory mask according to any one of aspects 43-46, wherein the elbow includes a first circumferential flange provided towards a proximal portion of the elbow and a second circumferential flange provided towards a distal portion of the elbow, wherein the seal is provided on the outer circumference of the elbow between the first and second flanges.
48. The respiratory mask according to aspect 47, further comprising a third circumferential flange between the first and second flanges, the seal being provided between the first and third flanges.
49. The respiratory mask according to any one of aspects 47-48, wherein the second flange includes a surface to engage an inboard surface of the socket of the frame.
50. The respiratory mask according to any one of aspects 48-49, wherein the third flange includes a surface that engages with a shoulder of the elbow.
51. The respiratory mask according to any one of aspects 48-50, further comprising a fourth circumferential flange adjacent the third flange, wherein the seal is provided between the third and fourth flanges.
52. The respiratory mask according to any one of aspects 43,47-51, wherein the seal includes a radial seal portion, an axial seal portion and an external seal portion.
53. The respiratory mask according to any one of aspects 43, 47-51 wherein the seal includes a radial lip seal that seals against an inner surface of a socket of the elbow and an axial lip seal that seals against an end face of the socket.
54. The respiratory mask according to aspect 35, wherein the mask includes a mask frame made at least in part from said elastomer and a retaining ring provided to the frame, wherein the retaining ring includes at least a selected portion including said substrate.
55. The respiratory mask according to aspect 35, further comprising a headgear assembly, wherein the headgear assembly includes a yoke associated with a strap and a seal ring provided to the yoke, wherein the yoke includes at least one selected portion including the substrate and the elastomer forms at least a part of the seal ring.
56. The respiratory mask according to aspect 39, wherein the mask includes a frame and a gas washout vent having at least one hole or pore, wherein the frame includes at least one selected portion including the substrate and the gas washout vent is formed at least in part from said elastomer.
57. The respiratory mask according to aspect 35, wherein the mask includes a frame having an aperture and a plug provided to close the aperture, the frame including at least a selected portion including said substrate and the plug is formed at least in part from said elastomer.
58. The respiratory mask according to aspect 35, wherein the mask includes a conduit including said substrate and a wall member formed at least in part by said elastomer, said substrate including a reinforcement structure.
59. The respiratory mask according to aspect 58, wherein said reinforcement structure includes a helical member.
60. The respiratory mask according to aspect 58, wherein said reinforcement structure includes at least two circular ribs interconnected by longitudinal members provided on alternating opposing sides of the wall member.
61. The respiratory mask according to aspect 58, wherein the reinforcement structure includes a plurality of circular ribs interconnected by dual longitudinal members provided on opposing sides of the wall member.
62. The respiratory mask according to aspect 35, wherein the frame includes a port portion and a port cap provided to the frame, wherein the port portion includes at least a selected portion including the substrate and the port cap is formed at least in part with said elastomer.
63. The respiratory mask according to aspect 35, wherein said mask includes a frame and an elbow provided to the frame, wherein said substrate with said treated portion is formed on an exterior surface of said frame and/or said elbow, and said elastomer is provided to each said treated portion to create a gripping portion and/or a logo.
64. The respiratory mask according to aspect 35, wherein said mask includes a frame with said treated portion and a bladder provided to the frame and formed at least in part from said elastomer.
65. The respiratory mask according to aspect 35, wherein the mask includes a frame including at least one port, and nasal cannulae, wherein the frame includes said treated portion of the substrate and the cannulae are formed at least in part from the elastomer, the cannulae being in communication with the port.
66. The respiratory mask according to aspect 35, wherein the mask includes a frame, an elbow provided to the frame, and a seal made at least in part from the elastomer, wherein said substrate is provided as part of said elbow or said frame.
67. The respiratory mask according to aspect 66, wherein the seal is formed on the elbow.
68. The respiratory mask according to aspect 67, wherein the seal is formed on an inner circumferential portion of the elbow to seal against a base portion of the frame inlet.
69. The respiratory mask according to aspect 67, wherein the seal is formed on an outer circumferential portion of the elbow to seal against the frame.
70. The respiratory mask according to aspect 68, wherein the seal is formed on the frame.
71. The respiratory mask according to aspect 66, wherein the seal is a syringe type seal.
72. The respiratory mask according to aspect 66, wherein the seal is a blade style seal.
73. The respiratory mask according to aspect 66, wherein the seal is an axial type seal structured to engage an angled face of the frame.
74. The respiratory mask according to aspect 66, wherein the seal has a generally rectangular cross-section.
75. The respiratory mask according to aspect 35, further comprising a forehead pad provided to a forehead support, the forehead pad being co-moulded to the forehead support and secured thereto without adhesion.
76. The respiratory mask according to aspect 35, wherein the mask includes a mask frame including the substrate and a mask cushion including the elastomer.
77. The respiratory mask according to aspect 76, wherein the frame includes a peripheral region and the cushion includes a T-shaped or L-shaped rim applied to the treated portion of the frame.
78. The respiratory mask according to aspect 76, wherein the treated portion forms at least a portion of a diagonal joint, a lap joint and/or a V-joint.
79. The respiratory mask according to aspect 76, wherein the cushion includes an expandable bladder having an interior defined by an interior surface of the elastomer and a portion of the frame that is not treated, and the frame includes a port to allow introduction of a substance delivered to the interior to expand the bladder.
80. The respiratory mask according to aspect 79, wherein the substance includes gel, foam, and/or liquid.
81. The respiratory mask according to aspect wherein the mask includes a mask frame a cushion and a cushion clip to secure the cushion to the frame, wherein the substrate is provided as part of the cushion clip and the cushion includes the elastomer.
82. The respiratory mask according to any one of aspects 35-81, wherein the treated portion includes a plasma treated surface.
83. The respiratory mask according to aspect 82, wherein the plasma treated surface is an atmospheric gas plasma treated surface.
84. The respiratory mask according to any one of aspects 35-81, wherein the selected portion includes a corona treated surface.
85. The respiratory mask according to any one of aspects 35-81, wherein the selected portion includes at least one surface treated with an adhesion promoter or solvent.
86. The respiratory mask according to any one of aspects 35-81, wherein the selected portion includes a flame oxidized surface.
87. The respiratory mask according to any one of aspects 35-81, wherein the adhesive bond includes an adsorptive bond, a chemical bond, a diffusion bond, and/or an electrostatic bond.
88. The respiratory mask according to aspect 35, wherein the relatively rigid material includes polycarbonate, polypropylene, polysulphone, phenol formaldehyde, thermoplastic or thermoset polymer..
89. The respiratory mask according to any one of aspects 35-88, wherein the relatively more flexible material includes liquid silicone rubber, solid silicone rubber and/or thermoplastic elastomers.
90. The respiratory mask according to aspect 35, wherein the treated portion of the substrate and the surface of the elastomer are overmoulded.
91. The respiratory mask according to aspect 90, wherein the selected portion of the substrate and the surface of the elastomer component are co-moulded.
92. The respiratory mask according to any one of aspects 35-91, wherein the elastomer is a non-self adhesive elastomer.
93. The respiratory mask according to any one of aspects 35-92, wherein portions of said elastomer in contact with the treated portion are subject to said adhesive bond while portions not in contact with said treated portion are not strongly bonded to the substrate.
94. The respiratory mask according to aspect 93, wherein said treated portion is only a sub-portion of said substrate.
95. A method for manufacturing a respiratory mask comprising:
wherein the mask includes a mask frame and an elbow provided to the frame, and wherein the elbow or frame includes at least one selected portion including said substrate, and the method further comprises overmoulding said elastomer onto the selected portion.
96. The method according to aspect 95, wherein said substrate is formed on one or more exterior surface portions of said frame and/or said elbow, and said elastomer is provided to each said exterior surface portion to create a gripping portion and/or a logo.
97. The method according to any one of aspects 95-96, wherein the elastomer is in the form of a seal formed on the elbow and/or frame.
98. The method according to aspect 97, wherein the seal is formed on an inner circumferential portion of the elbow to seal against a base portion of an inlet of the frame.
99. The method according to aspect 97, wherein the seal is formed on an outer circumferential portion of the elbow to seal against the frame.
100. The method according to any one of aspects 97-99, wherein the seal is a syringe type seal.
101. The method according to any one of aspects 97-99, wherein the seal is a blade style seal.
102. The method according to any one of aspects 97-99, wherein the seal is an axial type seal structured to engage an angled face of the frame.
103. The method according to any one of aspects 97-99, wherein the seal has a generally rectangular cross-section.
104. The method according to aspect 97, wherein the seal includes a relatively long elastomer lip flexibly positionable and bendable against and adjacent a socket of the frame, and at least one relatively shorter lip positioned between the relatively long elastomer lip and an outer circumference of the elbow in use.
105. The method according to aspect 97, wherein the seal includes at least one relatively shorter lip extending radially between the elbow and the socket of the frame.
106. The method according to any one of aspects 104-105, wherein the at least one relatively shorter lip includes two lips.
107. The method according to any one of aspects 94, 104-106, wherein the elbow includes a first circumferential flange provided towards a proximal portion of the elbow and a second circumferential flange provided towards a distal portion of the elbow, wherein the seal is provided on the outer circumference of the elbow between the first and second flanges.
108. The method according to aspect 107, further comprising a third circumferential flange between the first and second flanges, the seal being provided between the first and third flanges.
109. The method according to any one of aspects 107-108, wherein the second flange includes a surface to engage an inboard surface of the socket of the frame.
110. The method according to any one of aspects 108-109, wherein the third flange includes a surface that engages with a shoulder of the elbow.
111. The method according to any one of aspects 108-110, further comprising a fourth circumferential flange adjacent the third flange, wherein the seal is provided between the third and fourth flanges.
112. The method according to any one of aspects 97, 107-111, wherein the seal includes a radial seal portion, an axial seal portion and an external seal portion.
113. The method according to any one of aspects 97, 107-111 wherein the seal includes a radial lip seal that seals against an inner surface of a socket of the elbow and an axial lip seal that seals against an end face of the socket.
114. The method according to aspect 95, wherein the elbow includes a plurality of components and the selected portion includes the interface between any two elbow components.
115. The method according to aspect 95, wherein the frame includes a socket defining said substrate and the elastomer is provided to said socket.
116. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame, a cushion provided to the frame and a forehead support positioned above the frame, wherein the mask comprises a flexible portion coupling the frame and the forehead support, the flexible portion including a structural member including said substrate and at least one disc or tube including said elastomer.
117. The method according to aspect 116, wherein the tube has first and second ends that are co-moulded to the frame and the forehead support, respectively.
118. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame made at least in part from said elastomer and a retaining ring including said substrate, wherein the method further includes overmoulding the frame onto the ring.
119. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask comprises a frame and a cushion and a headgear assembly to support the frame and cushion, wherein the headgear assembly includes a yoke associated with a strap and a seal ring provided to the yoke, wherein the yoke includes at least one selected portion including the substrate and the method comprises overmoulding the seal ring onto the yoke.
120. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a frame and a gas washout vent having at least one hole or pore, wherein the frame includes at least one selected portion including the substrate and the method comprises co-moulding the gas washout vent onto the frame.
121. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a frame having an aperture and a plug provided to close the aperture, the frame including at least a selected portion including said substrate and the method comprise overmoulding the plug onto the frame.
122. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a conduit including said substrate and a wall member formed at least in part by said elastomer, and said method further comprises overmoulding the wall member and the reinforcement member.
123. The method according to aspect 122, wherein said reinforcement structure includes a helical member.
124. The method according to aspect 122, wherein said reinforcement structure includes at least two circular ribs interconnected by longitudinal members provided on alternating opposing sides of the member wall.
125. The method according to aspect 122, wherein the reinforcement structure includes a plurality of circular ribs interconnected by dual longitudinal members provided on opposing sides of the member wall.
126. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the frame includes a port portion and a port cap provided to the frame, wherein the port portion includes at least a selected portion including the substrate and the method further comprises overmoulding the port cap onto the frame.
127. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein said mask includes a frame with said substrate and a bladder is provided to the frame and formed at least in part from said elastomer.
128. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a frame including at least one port, and nasal cannulae, wherein the frame includes said substrate and the cannulae are formed at least in part from the elastomer, the cannulae being in communication with the port.
129. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a frame, a cushion, a forehead support positioned above the frame, and a forehead pad provided to the forehead support, the forehead pad including said elastomer and the forehead support including said substrate.
130. A method for manufacturing a respiratory mask comprising:
Overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame including the substrate and a mask cushion including the elastomer, wherein the frame includes a peripheral region and the cushion includes a T-shaped or L-shaped rim overmoulded to the frame.
131. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame including the substrate and a mask cushion including the elastomer, in which the mask frame and the mask cushion form at least one of a diagonal joint, a lap joint and/or a V-joint.
132. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a frame and a cushion, the cushion having an expandable bladder having an interior defined by an interior surface of the elastomer and a portion of the frame that is not treated, and the frame includes a port to allow introduction of a substance delivered to the interior to expand the bladder.
133. The method according to aspect 132, wherein the substance includes gel, foam, and/or liquid.
134. A method for manufacturing a respiratory mask comprising:
overmoulding an elastomer to or with the substrate, wherein the mask includes a mask frame a cushion and a cushion clip to secure the cushion to the frame, wherein the substrate is provided as part of the cushion clip and the cushion includes the elastomer.
135. The method according to any one of aspects 95-134, wherein the overmoulding includes selectively treating the substrate with plasma.
136. The method according to aspect 135, wherein the plasma is an atmospheric gas plasma.
137. The method according to any one of aspects 95-134, wherein the overmoulding includes one or more of the following: corona treatment, co-injection moulding, moving cores moulding, rotating platen and/or stripper plate moulding.
138. The method according to any one of aspects 95-134, wherein the overmoulding includes treating at least one surface with an adhesion promoter or solvent.
139. The method according to any one of aspects 95-134, wherein the overmoulding includes treating at least one surface of the substrate with flame oxidation.
140. The method according to any one of aspects 95-134, further comprising bonding the substrate and the elastomer to form an adhesive bond including at least one of an adsorptive bond, a chemical bond, a diffusion bond, and/or an electrostatic bond.
141. The method according to any one of aspects 95-140, wherein the relatively rigid material includes polycarbonate, polypropylene, polysulphone, phenol formaldehyde, thermoplastic or thermoset polymer.
142. The method according to any one of aspects 95-141, wherein the elastomer includes liquid silicone rubber, solid silicone rubber and/or thermoplastic elastomers.
143. The method according to aspect 95, wherein the selected portion of the substrate and the surface of the elastomer component are co-moulded.
144. The method according to any one of aspects 95-141, wherein the elastomer is a non-self adhesive elastomer.
145. The method according to any one of aspects 95-143, wherein portions of said elastomer in contact with the selected portion are subject to said adhesive bond while portions not in contact with said treated portion are not bonded to the substrate.
146. The method according to aspect 95, wherein said selected portion is only a sub-portion of said substrate.
147. A humidifier tub for a flow generator comprising:
an elastomer that is made of a relatively more flexible material compared to the relatively rigid material of the substrate, said elastomer being applied to the substrate and secured to the substrate via an induced adhesive bond formed between said treated portion and a surface of the elastomer abutting the treated portion
wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer.
148. A method for manufacturing a humidifier tub comprising:
overmoulding an elastomer to or with the substrate, wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer.
149. A humidifier tub comprising:
a substrate made of a relatively rigid material; and
an elastomer overmoulded with or to the substrate, wherein the humidifier tub includes a lid having said substrate and a seal made in part from said elastomer.
A method for manufacturing a respiratory mask, comprising:
providing an elastomeric material for forming into a first component;
providing a second component that is less flexible than the elastomeric material in a mould; and
integrally forming the elastomeric material onto the second component within the mould in order to form the first component, characterized in that the first component is joined to the second component in both a manually separable manner and a manually non-separable adhering manner, in different places, further comprising pre-treating the second component in selected places to strengthen the manually non-separable adhesion between the first and second components relative to the non-selected places of the second component.
The method as claimed in claim 1, wherein the first component can be removed from the second component in the separably joined places.
The method as claimed in clams 1 or 2, wherein the pre-treating step comprises applying plasma to a bonding surface of the second component.
The method as claimed in claim 3, wherein the plasma is an atmospheric gas plasma.
The method as claimed in one of the claims 1 to 4, wherein the integral forming is carried out in an injection moulding tool.
EP20060760882 2005-07-19 2006-07-19 Method for manufacturing a respiratory mask Active EP1910053B1 (en)
EP1910053A1 true EP1910053A1 (en) 2008-04-16
EP1910053A4 true EP1910053A4 (en) 2010-03-24
EP1910053B1 true EP1910053B1 (en) 2016-04-27
EP20060760882 Active EP1910053B1 (en) 2005-07-19 2006-07-19 Method for manufacturing a respiratory mask
EP20060762713 Active EP1909876B1 (en) 2005-07-19 2006-07-19 Breathing mask device and method for producing same
US20140083431A1 (en) 2014-03-27 application
Inventor name: LANG, BERND, C.
Inventor name: HENRY, ROBERT, EDWARD
Inventor name: CAMPBELL, GEORGE, GILES
Inventor name: HUXTABLE, PAUL, STEWART
Inventor name: PENDERGRAST, IAN, HOWARD
Inventor name: BURZ, JOHANN, S.
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