Respiratory interface device and method of manufacturing a sealing member for a respiratory interface device

Abstract

A method of manufacturing a sealing member for a respiratory interface device is provided. The method includes the steps of: (a) providing a mold having a cavity, a polymer injection port, and a gas inlet port; (b) injecting a polymer through the polymer injection port into the cavity of the mold; and (c) introducing a gas through the gas inlet port into the cavity of the mold to form a sealing member of the respiratory interface device, thereby forming a sealing member of the respiratory interface device. The sealing member of the respiratory interface device includes an interior chamber at least partially bounded by an elastically deformable wall formed from the polymer, the wall including a patient contact surface having a conformation determined by the cavity of the mold and providing an anatomic fit with a patient.

Description

[0001] This invention relates to a breathing interface device and related manufacturing methods.

[0002] Respiratory equipment typically includes some form of respiratory interface device to connect the equipment to a patient's respiratory system. A variety of different interface devices exist, including non-invasive devices such as face masks and nasal masks, and invasive devices such as endotracheal tubes and supraglottic airways, such as laryngeal mask airways.

[0003] Many of these interface devices are adapted to seal surfaces of the patient's body, either external or internal, to form an effective seal with the patient's airway. For example, non-invasive interface devices typically include a sealing member that seals the device to the patient's face, thereby forming an effective connection between the device and the patient's mouth and / or nose, while invasive interface devices typically include a sealing member that seals the device to the inner surface of the patient's airway, thereby forming an effective connection between the device and the airway.

[0004] Many of these breathing interface devices include inflatable sealing components, such as sealing gaskets or sealing sleeves, which are formed by thin walls surrounding an inflatable internal chamber.

[0005] An example of a breathing interface device is an anesthesia mask. An anesthesia mask is a breathing mask worn over a patient's nose and mouth while anesthetic gas is delivered to the patient. These masks typically include a mask body comprising a tubular connector for connection to an anesthetic gas supply device, and an inflatable sealing pad extending around the outer edge of the mask body's inlet. The walls of the inflatable sealing pad are thin, requiring sufficient gas pressure exceeding atmospheric pressure inside the pad to maintain its shape and elastic deformation. The sealing pad typically includes an inlet with a one-way valve that allows the sealing pad to inflate. The sealing pad can also be deflated using a syringe. In use, a standard anesthesia mask with an inflatable sealing pad is placed over the patient's nose and mouth and pushed toward the patient's face until a sufficient seal is achieved to deliver the anesthetic gas to the patient. However, considerable pressure may be required to achieve an acceptable seal.

[0006] Another significant drawback of breathing interface devices that include an inflatable section is manufacturing cost. They typically require an assembly step to attach the inflatable section to the rest of the device, and in many devices, an additional step is needed to provide a valve to allow the inflatable section to inflate. Specifically, blow molding is commonly used to form the inflatable sealing member, which is then glued to the body portion, such as a more rigid mask body. Blow molding uses a preformed insert with a hollow interior that is inflated within a mold in a process called injection blow molding, or an extruded preform clamped at both ends and inflated within a mold in a process called extrusion blow molding.

[0007] Another approach to using inflatable portions in breathing interface devices is to provide a sealing member with an anatomically shaped and anatomically conformal design to provide an effective seal with the patient (e.g., the patient's face). These devices can be formed in a secondary injection molding process, which reduces assembly steps compared to manufacturing breathing interface devices with inflatable portions. These masks typically require relatively low pressure to achieve an acceptable seal. However, a drawback of these devices is that, without achieving an acceptable seal, the sealing pad or bladder may not conform well to the patient's face when increased pressure is applied, and there is a risk that the sealing member will deform and open if pressure is applied, resulting in leakage.

[0008] Improved methods for manufacturing breathing interface devices and improved breathing interface devices have now been designed, which overcome or significantly reduce the above and / or other disadvantages associated with the prior art.

[0009] According to a first aspect of the present invention, a method for manufacturing a sealing member for a breathing interface device is provided, the method comprising the following steps:

[0010] (a) Provide a mold with a cavity, a polymer injection port and an air inlet;

[0011] (b) Injecting the polymer into the cavity of the mold through a polymer injection port; and

[0012] (c) Introduce gas into the mold cavity through the air inlet.

[0013] This forms a sealing member for a breathing interface device, wherein the sealing member includes an internal chamber defined at least partially by an elastically deformable enclosure formed of a polymer, the enclosure including a patient contact surface having a shape defined by a mold cavity and providing anatomical fit with the patient.

[0014] The method according to the invention provides a sealing member for a breathing interface device, comprising an internal chamber at least partially defined by an elastically deformable enclosure defined by a polymer, and thus capable of functioning in a manner similar to an inflatable portion of the prior art, and an enclosure including a patient contact surface having a morphology defined by a cavity of a mold and providing an anatomically compatible fit with the patient, and thus capable of being configured to function in a manner similar to an anatomically shaped sealing membrane of the prior art. This combination of features enables the formation of a sealing member that provides an effective seal with the patient through its anatomically compatible fit, but where a greater seal is required, the sealing member can also be pushed toward the patient, for example, toward the patient's face, via its internal chamber.

[0015] The patient contact surface can provide an anatomical fit with the patient before any deformation of the sealing member occurs during use; that is, the patient contact surface can be anatomically shaped. To provide this anatomical fit, the patient contact surface can have a guide portion, which is the portion of the surface that contacts the patient before any deformation of the sealing member, and is anatomically shaped. The anatomical shape can be defined at least in the engagement direction between the sealing member and the patient surface, such that the position of the guide portion of the patient contact surface varies in this direction, for example, at different locations along the patient contact surface. The guide portion of the patient contact surface can have a closed-loop shape, for example, extending around the mask body for a breathing mask, or an airway tube or endotracheal tube for a laryngeal mask airway. The centerline of the guide portion and / or the guide portion of the patient contact surface can have a varying position relative to a reference surface, such as a reference plane or a reference cylinder, wherein the reference surface can be arranged perpendicular to the engagement direction between the sealing member and the patient surface, or the direction of the overall pressure applied by the sealing member to the patient surface. The centerline of the guide portion and / or the guide portion of the patient contact surface can have a non-linearly varying position relative to the reference surface.

[0016] The mold's air inlet can be connected to a gas source, which may include a controller for determining the volume, pressure, temperature, and / or time period for introducing the gas. The gas may have a pressure sufficient to guide, deform, and / or move the polymer within the mold cavity to form a sealing member. For example, the gas may be injected, for instance, through a gas injection port, and may be supplied by a compression source. When the gas is supplied by a compression source, the gas may be nitrogen or another sufficiently inert gas.

[0017] The air inlet of the mold can protrude into the cavity, for example, in the form of a nozzle. The air inlet can protrude relative to the surrounding inner surface of the defined cavity of the mold. The air inlet can have an outlet opening through which gas enters the cavity. When the sealing member is fitted to a patient, the longitudinal axis of the sealing member can correspond to the longitudinal axis of the patient. For a sealing member used in a breathing mask, the air inlet can be located at the end of the cavity corresponding to the nasal apex of the sealing member used in a breathing mask.

[0018] The outlet opening of the air inlet can be formed in the wall of the mold. The outlet opening can be separated from the surrounding inner surface of the mold's defined cavity. The outlet opening can be positioned substantially centrally relative to the cross-section of the cavity, for example, within the range of 35-65% of the longest dimension of the cavity's cross-section. A transverse plane refers to a plane of the cavity oriented substantially perpendicular to the central axis of the cavity, extending along the center of the annular cavity.

[0019] The air inlet may protrude relative to the surrounding inner surface of the defined cavity of the mold, which can result in the formation of a hole in the surrounding wall of the sealing member. The hole can communicate fluidly with the internal cavity of the sealing member.

[0020] According to another aspect of the present invention, a method for manufacturing a sealing member for a breathing interface device is provided, the method comprising the following steps:

[0021] (a) Provide a mold with a cavity, a polymer injection port and an air inlet;

[0022] (b) Injecting the polymer into the cavity of the mold; and

[0023] (c) Introduce gas into the mold cavity through the air inlet.

[0024] This forms the sealing component of the breathing interface device.

[0025] The sealing member of the breathing interface device includes an internal chamber defined at least partially by an elastically deformable enclosure formed of a polymer, the enclosure including a patient contact surface, and wherein an air inlet protrudes relative to the surrounding inner surface of the defined cavity of the mold, such that a hole is formed in the enclosure of the sealing member.

[0026] The orifice can be in fluid communication with the internal cavity of the sealing component.

[0027] In a breathing mask, orifices in the sealing member provide fluid communication between the internal chamber of the sealing member and ambient air. In invasive breathing interface devices such as laryngeal mask airways, orifices in the sealing member provide fluid communication between the internal chamber of the sealing member and a gas source for inflating the sealing member.

[0028] The air inlet of the cavity can be set to be adjacent to the polymer injection port of the cavity.

[0029] The volume of polymer injected into the mold cavity can be smaller than the cavity volume. During polymer injection, the polymer will be sufficiently soft to flow, for example, in the form of a polymer melt. After polymer injection, but before gas introduction, the polymer can extend only partially along the cavity. The polymer can then have a monolithic form, separated from the end of the cavity opposite the end where the polymer injection port is located.

[0030] The polymer injection port for the cavity can be located at one end of the sealing member during manufacturing, and the sealing member can be formed by polymer flowing from the polymer injection port along the cavity in two directions.

[0031] The injected gas can guide, deform, and / or move the polymer within the mold cavity to form a sealing member. The gas can apply pressure to the polymer to form internal chambers and walls. The pressure applied by the gas can have a radial component that can guide, deform, or move the polymer outward toward the inner surface of the cavity, thereby forming the walls of the sealing member. The pressure applied by the gas can also have an axial component that can guide, deform, or move the polymer axially along the cavity away from the air inlet.

[0032] The step of introducing gas into the cavity of the mold through an air inlet can form bubbles extending from the air inlet within the polymer. The air inlet can be located at one end of a sealing member during manufacturing, and the internal cavity can be formed by the injected gas flowing from the air inlet through the polymer along the cavity in two directions. However, other arrangements can be used, including multiple air inlets in different areas of the cavity.

[0033] The internal chamber can be filled with gas during manufacturing. The thickness of the formed enclosure wall can be less than 4 mm, or less than 3 mm, or less than 2.5 mm. The enclosure wall can have a substantially uniform thickness, with the average thickness variation being less than 20% over at least a majority of the internal chamber, for example, over at least 80% of the surface area of ​​the enclosure wall.

[0034] The gas introduced into the cavity can also cause the polymer to move along the cavity, for example toward the end of the cavity opposite to the end of the cavity where the polymer injection port and / or air inlet is located.

[0035] The polymer can move in opposite directions along a cavity from a polymer inlet and / or an air inlet, wherein the cavity has a closed-loop shape such that the polymer has two branches advancing along the cavity. The branches of the polymer can meet and engage to form a sealing member of the breathing interface device that extends along the closed loop.

[0036] The sealing member may have a solid portion, i.e., a portion without an internal chamber, which may be located at the end of the cavity opposite the air inlet. The internal chamber formed by the injected gas may therefore have a first end and a second end, which can be separated by a continuous solid body of polymer, for example, at the end of the breathing interface device opposite the air inlet. The internal chamber may include a tapered end adjacent to the solid portion of the sealing member.

[0037] The solid portion can provide greater resistance to deformation of the sealing member in one or more selected areas. For example, the solid portion can provide greater resistance to deformation of the sealing member of the breathing mask in one or more selected areas (e.g., the chin region), which can eliminate the need for a separate reinforcement structure. Similarly, the solid portion can provide greater resistance to deformation of the tip region of the sealing cuff of the laryngeal mask airway, which can reduce the risk of the sealing cuff folding during insertion into the patient's airway and can eliminate the need for a separate reinforcement structure.

[0038] One or more additional air inlets can be provided to allow the introduction of gas with pressure that counteracts the movement of the polymer along the cavity. As the polymer moves along the cavity, the gas introduced through the one or more additional air inlets can be discharged.

[0039] The internal chamber can be filled with gas during manufacturing, and this gas can be replaced with ambient air once the sealing element has been removed from the mold. The sealing element may include openings or fluid passages that allow gas or ambient air to enter or exit the internal chamber.

[0040] The mold may include a polymer injection port for the cavity. The injection molding step may involve an injection unit. The injection unit may be configured to heat the polymer until it is soft enough to flow, thereby forming a polymer melt, and the injection unit may be moved to engage and fluidly communicate with the injection port of the mold cavity. The injection unit may then apply pressure to the polymer melt and inject the polymer melt into the mold cavity through the polymer injection port. If the polymer is a thermoplastic, the polymer melt within the cavity may be cooled to allow the polymer to solidify. If the polymer is a thermoset, the polymer may be heated in the injection unit until it is soft enough to flow, but the temperature does not cause solidification, and the polymer melt within the cavity may be heated to cause solidification of the polymer. Alternatively, in liquid injection molding, the polymer may be a liquid mixture rather than a polymer melt, which may be at room temperature or lower in the injection unit and then solidified within the mold, for example, by heating.

[0041] According to another aspect of the present invention, a method for manufacturing a sealing member for a breathing interface device is provided, the method comprising the following steps:

[0042] (a) Provide a mold with a cavity, a polymer injection port and an air inlet;

[0043] (b) Injecting the polymer into the cavity of the mold through a polymer injection port; and

[0044] (c) Introduce gas into the mold cavity through the air inlet.

[0045] This forms the sealing component of the breathing interface device.

[0046] Such that an internal cavity, at least partially defined by an elastically deformable enclosure formed of polymer, is formed in a sealing member within the cavity of a mold, the enclosure including a patient contact surface that provides anatomical fit with the patient.

[0047] According to another aspect of the present invention, a method for manufacturing a sealing member for a breathing interface device is provided, the method comprising the following steps:

[0048] (a) Provide a mold with a cavity, a polymer injection port and an air inlet;

[0049] (b) Injecting the polymer into the cavity of the mold through a polymer injection port; and

[0050] (c) When the cavity of the mold is at least partially filled with polymer, gas is introduced into the cavity of the mold through an air inlet.

[0051] This forms the sealing component of the breathing interface device.

[0052] The sealing component of the breathing interface device includes an internal chamber defined at least partially by an elastically deformable enclosure formed of a polymer, the enclosure including a patient contact surface that provides anatomical fit with the patient.

[0053] According to another aspect of the present invention, a method for manufacturing a sealing member for a breathing interface device is provided, the method comprising the following steps:

[0054] (a) Provide a mold with a cavity, a polymer injection port and an air inlet;

[0055] (b) Injecting the polymer into the mold cavity through a polymer injection port, such that the mold cavity is only partially filled; and

[0056] (c) Introduce gas into the mold cavity through the air inlet.

[0057] This forms the sealing component of the breathing interface device.

[0058] The internal chamber is at least partially defined by an elastically deformable enclosure formed of a polymer, the enclosure including a patient contact surface that provides anatomical fit with the patient.

[0059] According to another aspect of the invention, a sealing member manufactured by any of the methods defined above is provided.

[0060] According to another aspect of the invention, a sealing member for a breathing interface device is provided, the sealing member including an internal chamber defined at least partially by an elastically deformable enclosure wall, the enclosure wall including a patient contact surface having a shape that provides anatomical fit with a patient, wherein the sealing member includes an internal chamber of the sealing member and an orifice in fluid communication with ambient air, such that ambient air can enter and exit the internal chamber during use.

[0061] A sealing member according to this aspect of the invention comprises an elastically deformable enclosure including a patient contact surface providing an anatomically compatible fit with the patient, and an internal cavity and an orifice defined at least partially by the elastically deformable enclosure through which ambient air can enter and exit during use. This combination of features provides the sealing member with an effective seal to the patient by virtue of its anatomically compatible fit, but when a greater seal is required, the sealing member can also be pushed toward the patient, for example, toward the patient's face, by virtue of its internal cavity and the orifice through which ambient air can enter and exit during use. In particular, compared to prior art inflatable sealing members, the internal cavity and the orifice through which ambient air can enter and exit during use provide greater deformability to the elastically deformable enclosure of a given thickness of the sealing member. This achieves a thicker wall than prior art inflatable sealing members that do not allow gas to exit the internal cavity during use, and this thicker wall provides advantages including better maintenance of the anatomical shape during and after deformation, improved durability and reduced risk of damage, and the ability to achieve a sealing member that does not require re-inflating before use. Furthermore, compared to the non-inflatable sealing components of the prior art, this aspect of the invention reduces the risk of the sealing component opening and causing leakage when pressure is applied by a clinician.

[0062] The patient contact surface of the sealing member can therefore be formed with a predetermined anatomical shape. The patient contact surface of the sealing member can have a closed-loop morphology.

[0063] When a sealing component is used in a breathing mask, the patient contact surface is typically aligned with the patient's forehead plane during use, but may include a convex surface in the cheek region of the patient contact surface and / or a concave surface in the nose and / or chin region of the patient contact surface in the circumferential direction. The patient contact surface may include a convex surface in the transverse or radial direction. The circumferential convex surface of the patient contact surface may extend along a large portion of the length of the mask, and the circumferential concave surface of the patient contact surface may extend along the width of the mask, for example, at each end. In use, the convex curvature and / or concave curvature can provide a varying position of the patient contact surface relative to the patient's sagittal axis.

[0064] When the sealing member is used for a laryngeal mask airway or endotracheal tube, the sealing member may have a shape that provides an anatomical fit to the patient's larynx or trachea.

[0065] An orifice may be provided in the enclosure wall of the sealing member. The orifice may be in fluid communication with an internal chamber of the sealing member. In the case of multiple internal chambers, each internal chamber may have an orifice provided in the enclosure wall of the sealing member.

[0066] In a breathing mask, the orifice in the sealing member provides fluid communication between the internal chamber of the sealing member and ambient air. In this embodiment, if a stronger seal is needed during use, the user can push the sealing member toward the patient's face, for example, by applying pressure to the patient's face at the breathing device interface. The sealing member and the internal chamber will be compressed, causing air to leave the internal chamber, but the elasticity of the sealing member may be sufficient to prevent the internal chamber from completely collapsing, i.e., maintaining separation between the opposing inner surfaces of the enclosure, and returning to its original shape once the pressure is removed.

[0067] The orifice may be normally open, or it may be opened by air flowing into and out of the internal chamber of the sealing member. The orifice may not have any valve with a closing configuration. In some embodiments, the orifice may include a valve that regulates the flow of ambient air into and out of the internal chamber of the sealing member.

[0068] In invasive breathing interface devices such as laryngeal mask airways, holes in the sealing member can provide fluid communication between the internal chamber of the sealing member and a gas source for inflating the sealing member, and can thus form part of a supply catheter or a connector for the supply catheter.

[0069] The sealing member may have a ring shape. The internal cavity of the sealing member may be continuous and extend at least most of the way around the ring. The internal cavity may have a central longitudinal axis along a curved path. The curved path may extend at least most of the way around the ring.

[0070] The ring can be circular, elliptical, triangular, or similarly elliptical in shape. For example, the sealing member can be a sealing membrane for a breathing interface device, and the outer surface can be a patient contact surface. The patient contact surface can have holes formed therein for receiving the nasal and / or mouth areas of the patient's face. The patient contact surface and / or the holes therein can be substantially triangular in shape, i.e., matching the shape of the nose and mouth of the patient's face.

[0071] The internal chamber may extend about 80% or 90% of the length of the ring. The internal chamber may extend about 80-100%, 80-90%, or 90-100% of the length of the ring. The length of the ring may refer to the length of the ring's central axis. The ring may extend at a 360-degree angle, and the internal chamber may extend about 300-360 degrees, 300-330 degrees, or 330-360 degrees around the ring. In some instances, the internal chamber may extend about the entire ring, meaning the internal chamber may also form a ring.

[0072] The cross-sectional area of ​​the internal chamber can vary, for example, by means of variations in the position and / or thickness of the surrounding walls.

[0073] The sealing member may have one or more solid portions, i.e., portions without an internal chamber. The internal chamber may have a first end and a second end, which can be separated from the one or more solid portions of the sealing member. The internal chamber may include a tapered end adjacent to the solid portion of the sealing member.

[0074] According to another aspect of the invention, a sealing member for a breathing interface device is provided, the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure including a patient contact surface, and the internal chamber having a first end and a second end separated by one or more solid portions of the sealing member.

[0075] One or more solid portions of the sealing member separating the first and second ends of the internal chamber can be a single continuous solid portion.

[0076] One or more solid sections can provide greater deformation resistance to the sealing member in one or more selected areas. For example, one or more solid sections can provide greater deformation resistance to the sealing member of a breathing mask in one or more selected areas (e.g., the chin region), which can eliminate the need for a separate reinforcement structure. Similarly, one or more solid sections can provide greater deformation resistance to the tip region of the sealing cuff of a laryngeal mask airway, which can reduce the risk of the sealing cuff folding during insertion into the patient's airway and can eliminate the need for a separate reinforcement structure.

[0077] Compared to existing methods for manufacturing inflatable sealing components, such as blow molding, it has been found that the method for manufacturing sealing components of a breathing interface device according to the present invention can manufacture the breathing interface device with fewer assembly steps, reduced manufacturing time, and lower manufacturing costs. In particular, it has been found that the method for manufacturing sealing components of a breathing interface device according to the present invention can be incorporated into a manufacturing process in which the step of forming the sealing component also secures the sealing component to the body portion of the breathing interface device, such as through secondary injection molding or overmolding processes. This is typically not possible when manufacturing breathing interface devices with inflatable sealing components.

[0078] According to another aspect of the invention, a sealing member for a breathing interface device is provided, the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure, the enclosure including a patient contact surface, and the patient contact surface having a morphology that provides anatomical fit with a patient.

[0079] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising a method for manufacturing a sealing member for a breathing interface device as defined above.

[0080] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0081] (a) Providing one or more molds, the molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port into the second cavity, and an air inlet opening;

[0082] (b) Injecting the first polymer into the first cavity of the mold through the first polymer injection port to form the body part of the breathing interface device;

[0083] (c) Injecting a second polymer into a second cavity of one or more molds through a second polymer injection port, and introducing gas into the second cavity of one or more molds through an air inlet to form a sealing member of a breathing interface device, the sealing member comprising an internal chamber at least partially defined by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of one or more molds and providing anatomical conformation to the patient; and

[0084] The body portion and sealing member of the breathing interface device can be formed in any order, such that either the body portion or the sealing member is formed earlier, and the other of the body portion and the sealing member is formed later. During the injection molding process of the later formed portion, the later formed portion is joined to the earlier formed portion in a manner that fixes the body portion and the sealing member of the breathing interface device together.

[0085] The method for manufacturing a breathing interface device according to the present invention is advantageous because, compared with prior art methods for forming a breathing interface device with an inflatable portion, it enables fewer assembly steps, reduces manufacturing time, and lowers manufacturing costs.

[0086] Methods for manufacturing a breathing interface device may include any or any combination of methods defined above for manufacturing sealing components for a breathing interface device.

[0087] The body portion of the breathing interface device formed by the method according to the invention may include a flow channel for the breathing interface device. The body portion of the breathing interface device may also include a connector for connecting the flow channel of the device to a breathing apparatus such as a breathing tube and / or a supply device for breathing gas.

[0088] The body portion of a breathing interface device is typically formed earlier, while the sealing member is typically formed later. However, in some embodiments, it may be advantageous for the sealing member to be formed earlier and the body portion later.

[0089] One or more molds having a first cavity, a second cavity, and an air inlet opening into the second cavity can be arranged such that an earlier formed portion of the breathing interface device can be located near or inside the cavity (first or second cavity) for forming a later formed portion of the breathing interface device, such that during the injection molding of the later formed portion, the later formed portion is joined to the earlier formed portion in a manner that secures the body portion and the sealing member of the breathing interface device together. During the injection molding of the later formed portion, the later formed portion can contact the earlier formed portion.

[0090] The bonding between the body portion and the sealing member can be achieved through one or more of chemical and mechanical bonding methods. The bonding can be formed immediately after the injection molding of a later-formed portion of the breathing interface device, eliminating the need for further assembly steps to secure the body portion and sealing member together.

[0091] The second polymer may contact the boundary region of the body portion of the breathing interface device, such as the mask body or airway tube, which may include a peripheral edge. In the case where the second polymer contacts a single boundary region of the body portion of the breathing interface device, the internal chamber may be defined solely by a wall defined by the second polymer.

[0092] The air inlet may protrude relative to the inner surface of the defined first or second cavity of the mold, which may allow a hole to be formed in the body portion of the breathing device and / or in the wall of the sealing member of the breathing interface device.

[0093] The air inlet of the mold can protrude into the second cavity relative to the surrounding inner surface of the mold defining the second cavity.

[0094] In this embodiment, the earlier formed portion can be formed in a first or second cavity of the mold in a first injection configuration. The mold can then be moved to a second injection configuration such that the earlier formed portion of the breathing interface device is positioned near another of the first or second cavities used to form a later formed portion of the breathing interface device. During the injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that secures the body portion and sealing member of the breathing interface device together. For example, in the second injection configuration of the mold, surfaces of the body portion of the breathing interface device, such as the peripheral edge of the body portion and the boundary region of the surface adjacent to the peripheral edge, can be exposed to the interior of the cavity used to form the later formed portion of the breathing interface device. It should be noted that the first cavity can be defined by the mold in the first injection configuration, and the second cavity can be defined by the mold in the second injection configuration, but the first and second cavities are not necessarily defined simultaneously by the mold. Therefore, the mold can be provided in a single injection molding machine, and this process is generally referred to as two-stage injection molding.

[0095] Alternatively, one or more molds may include a first mold defining a first cavity and a second mold defining a second cavity. In this embodiment, after an earlier formed portion of the breathing interface device is formed in the first or second mold, the first or second mold can be opened and the earlier formed portion can be transferred to the other of the first and second molds, such that the earlier formed portion of the breathing interface device is disposed within the cavity for forming a later formed portion of the breathing interface device, and during the injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that secures the body portion and the sealing member of the breathing interface device together. The first and second molds can therefore be provided in two separate injection molding machines, and this process is commonly referred to as overmolding.

[0096] Therefore, the method for manufacturing the breathing interface device can be a two-stage injection molding process or an overmolding process, and in both processes, the body portion of the breathing interface device is usually formed earlier, and the sealing component of the breathing interface device is usually formed later. These two embodiments are defined below.

[0097] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0098] (a) A mold having a first injection configuration defining a first cavity and a first polymer injection port, and a second injection configuration defining a second cavity, a second polymer injection port entering the second cavity, and an air inlet opening;

[0099] (b) Arrange the mold in the first injection configuration;

[0100] (c) Injecting the first polymer into the first cavity of the mold through the first polymer injection port to form the body part of the breathing interface device;

[0101] (d) Arrange the mold in the second injection configuration such that the body portion of the breathing interface device is located near the second cavity; and

[0102] (e) A second polymer is injected into a second cavity of a mold through a second polymer injection port, and gas is introduced into one or more second cavities of the mold through an air inlet to form a sealing member of a breathing interface device. During the injection molding of the sealing portion, the sealing member is engaged with the body portion in such a way that it secures the body portion of the breathing interface device and the sealing member together. The sealing member of the breathing interface device includes an internal cavity defined at least partially by an elastically deformable enclosure formed of the second polymer. The enclosure includes a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of the mold and provided to conform to the patient's anatomical structure.

[0103] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0104] (a) A first mold having a first cavity and a first polymer injection port, and a second mold having a second cavity, a second polymer injection port entering the second cavity, and an air inlet opening;

[0105] (b) Injecting a first polymer into a first cavity of a first mold through a first polymer injection port to form the body portion of the breathing interface device;

[0106] (c) Transferring the main body portion of the breathing interface device to the second mold, such that the main body portion of the breathing interface device is disposed within or near the second cavity; and

[0107] (d) A second polymer is injected into a second cavity of a second mold through a second polymer injection port, and gas is introduced into the second cavity of the second mold through an air inlet to form a sealing member of a breathing interface device. During the injection molding of the sealing portion, the sealing member is engaged with the body portion in a manner that fixes the body portion of the breathing interface device and the sealing member together. The sealing member of the breathing interface device includes an internal cavity defined at least partially by an elastically deformable enclosure formed of the second polymer. The enclosure includes a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of one or more molds and provided to conform to the anatomical fit of the patient.

[0108] The air inlet of the mold can protrude into the second cavity. The air inlet can protrude relative to the inner surface of the mold defining the second cavity. Alternatively, the air inlet can protrude into the second cavity through the body portion of the respirator. In a two-stage injection molding process, in the first injection configuration of the mold, the air inlet can protrude relative to the inner surface of the mold defining the first cavity, such that when the first polymer is injected into the first cavity of the mold to form the body portion of the respirator, the air inlet extends through the first polymer in the first cavity, and in the second injection configuration of the mold, the air inlet can then protrude into the second cavity through the body portion of the respirator.

[0109] The air inlet may have an outlet opening through which gas enters the second cavity. The outlet opening of the air inlet may be aligned with the longitudinal axis of the second cavity, and thus with the longitudinal axis of the breathing interface device. When the breathing interface device is fitted to a patient, the longitudinal axis of the breathing interface device may correspond to the longitudinal axis of the patient. For a breathing mask, the air inlet may be located at the end of the second cavity corresponding to the apex of the nose portion of the breathing mask.

[0110] During manufacturing, an opening for entry into the internal chamber can be formed around the air inlet, allowing ambient air to enter and exit the internal chamber during use. The opening can be formed within a resiliently deformable enclosure formed of a second polymer. Alternatively, the internal chamber can be at least partially defined by a wall having a first layer defined by a first polymer and a second layer defined by a second polymer, and the opening for entry into the internal chamber can be formed within said wall.

[0111] The air inlet may protrude relative to the surrounding inner surface of the defining first or second cavity of the mold, thereby forming an opening in the body portion of the breathing device and / or the surrounding wall of the sealing member of the breathing interface device. The opening may be in fluid communication with the internal chamber of the sealing member of the breathing interface device.

[0112] In a breathing mask, orifices can thus be formed in the mask body and / or sealing member, and the orifices can provide fluid communication between the internal chamber of the sealing member and ambient air. In invasive breathing interface devices such as laryngeal mask airways, orifices can provide fluid communication between the internal chamber of the sealing member and a gas source for inflating the sealing member.

[0113] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0114] (a) Providing one or more molds, the one or more molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port into the second cavity, and an air inlet opening;

[0115] (b) Injecting the first polymer into the first cavity of the mold through the first polymer injection port to form the body part of the breathing interface device;

[0116] (c) Injecting a second polymer into a second cavity of one or more molds through a second polymer injection port and introducing gas into the second cavity of one or more molds through an air inlet to form a sealing member of a breathing interface device, the sealing member of the breathing interface device including an internal chamber defined at least partially by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface;

[0117] The body portion and sealing member of the breathing interface device can be formed in any order, such that either the body portion or the sealing member is formed earlier, and the other is formed later. During the injection molding process of the later-formed portion, the later-formed portion is joined to the earlier-formed portion in a manner that fixes the body portion and sealing member of the breathing interface device together; and

[0118] The air inlet protrudes from the inner surface of the first or second cavity defined by the mold, such that a hole is formed in the enclosure of the body part of the breathing device and / or the sealing member of the breathing interface device, and the hole is in fluid communication with the internal cavity of the sealing member of the breathing interface device.

[0119] The method according to the invention can be used with one or more mold tools that define one or more molds having a first cavity and a second cavity, each cavity being defined by an inner wall of the mold.

[0120] The air inlet of the mold can protrude into the second cavity. The air inlet can protrude relative to the surrounding inner surface of the mold defining the second cavity. Alternatively, the air inlet can protrude into the second cavity through the body portion of the breathing mask.

[0121] Therefore, the method for manufacturing the breathing interface device can be a two-stage injection molding process or an overmolding process, and in both processes, the body portion of the breathing interface device is usually formed earlier, and the sealing component of the breathing interface device is usually formed later. These two embodiments are defined below.

[0122] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0123] (a) A mold having a first injection configuration defining a first cavity and a first polymer injection port, and a second injection configuration defining a second cavity, a second polymer injection port entering the second cavity, and an air inlet opening;

[0124] (b) Arrange the mold in the first injection configuration;

[0125] (c) Injecting the first polymer into the first cavity of the mold through the first polymer injection port to form the body part of the breathing interface device;

[0126] (d) Arrange the mold in the second injection configuration such that the body portion of the breathing interface device is located near the second cavity; and

[0127] (e) A second polymer is injected into a second cavity of a mold through a second polymer injection port, and gas is introduced into one or more second cavities of the mold through an air inlet to form a sealing member of a breathing interface device. During the injection molding of the sealing portion, the sealing member is engaged with the body portion in such a way that it secures the body portion of the breathing interface device and the sealing member together. The sealing member of the breathing interface device includes an internal cavity defined at least partially by an elastically deformable enclosure formed of the second polymer. The enclosure includes a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of the mold and provides anatomical fit with the patient.

[0128] The air inlet protrudes from the inner surface of the first or second cavity defined by the mold, such that a hole is formed in the enclosure of the body part of the breathing device and / or the sealing member of the breathing interface device, and the hole is in fluid communication with the internal cavity of the sealing member of the breathing interface device.

[0129] The air inlet may protrude relative to the inner surface surrounding the defining second cavity of the mold. Alternatively, in a first injection configuration of the mold, the air inlet may protrude relative to the inner surface surrounding the defining first cavity of the mold, such that when a first polymer is injected into the first cavity of the mold to form the body portion of the breathing interface device, the air inlet extends through the first polymer in the first cavity, and in a second injection configuration of the mold, the air inlet may then protrude through the body portion of the breathing mask into the second cavity.

[0130] According to another aspect of the present invention, a method for manufacturing a breathing interface device is provided, the method comprising the following steps:

[0131] (a) A first mold having a first cavity and a first polymer injection port, and a second mold having a second cavity, a second polymer injection port entering the second cavity, and an air inlet opening;

[0132] (b) Injecting a first polymer into a first cavity of a first mold through a first polymer injection port to form the body portion of the breathing interface device;

[0133] (c) Transferring the main body portion of the breathing interface device to the second mold, such that the main body portion of the breathing interface device is disposed within or near the second cavity; and

[0134] (d) A second polymer is injected into a second cavity of a second mold through a second polymer injection port, and gas is introduced into the second cavity of the second mold through an air inlet to form a sealing member of a breathing interface device. During the injection molding of the sealing part, the sealing member is engaged with the body part in such a way that the body part of the breathing interface device and the sealing member are fixed together. The sealing member of the breathing interface device includes an internal cavity defined at least partially by an elastically deformable enclosure formed of the second polymer. The enclosure includes a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of one or more molds and provides an anatomical fit to the patient.

[0135] The air inlet protrudes into the second cavity relative to the inner surface of the defined second cavity of the mold, thereby forming a hole in the wall of the sealing member of the breathing interface device, and the hole is in fluid communication with the internal cavity of the sealing member of the breathing interface device.

[0136] In some implementations, the air inlet can protrude into the second cavity through the body portion of the breathing mask, for example, through a hole formed during injection molding in the first mold.

[0137] Each cavity may have a single polymer inlet port with an outlet opening through which polymer enters the cavity. The outlet opening of the polymer inlet port may be aligned with the longitudinal axis of the second cavity, and thus with the longitudinal axis of the breathing interface device. When the breathing interface device is fitted to a patient, the longitudinal axis of the breathing interface device may correspond to the longitudinal axis of the patient. For a breathing mask, the polymer inlet port may be located at the end of the second cavity corresponding to the nasal apex of the breathing mask. The outlet opening may be formed in the wall of the mold and may be coplanar with the surrounding inner surface of the defining cavity of the mold.

[0138] Each of the first and second polymers can be injected into the corresponding cavity as a polymer melt, which is a polymer liquid above its glass and / or crystallization temperature. However, the injection molding process will differ depending on whether the polymer is a thermoplastic or a thermosetting plastic. Furthermore, in liquid injection molding, the polymer can be a liquid mixture rather than a polymer melt, which solidifies within the mold, for example, by heating.

[0139] A first polymer can be supplied to a first injection unit. The first polymer can be heated in the injection unit until it is soft enough to flow, thereby forming a first polymer melt, and the first injection unit can be moved to engage and fluidly communicate with the injection port of a first cavity of the mold.

[0140] A second polymer can be supplied to the second injection unit. The second polymer can be heated in the second injection unit until it is soft enough to flow, thereby forming a second polymer melt, and the second injection unit can be moved to engage and fluidly communicate with the injection port of the second cavity of the mold.

[0141] A first polymer is injected into a first cavity of a mold to form the body portion of a breathing interface device, such as the mask body of a breathing mask or the airway tube or endotracheal tube of a laryngeal mask airway. The first polymer may be polypropylene, poly(styrene-butadiene-styrene) (SBS), polycarbonate, or other suitable materials. The first polymer and the second polymer may be different.

[0142] A second polymer is injected into a second cavity of a mold to form a sealing member of the breather interface device. The elastic modulus of the second polymer may be lower than that of the corresponding elastic modulus of the first polymer. The second polymer may be a thermoplastic elastomer or a thermosetting elastomer, such as liquid silicone rubber.

[0143] In the case of a two-stage injection molding process, the polymer for the later-formed portion can be injected into the mold cavity after the polymer for the earlier-formed portion has been injected and before the polymer for the earlier-formed portion has fully cured. In the case of an overmolding process, the earlier-formed portion of the breather interface device can be substantially or completely cured before being transferred to the cavity for forming the later-formed portion of the breather interface device.

[0144] When the polymer is a thermoplastic, the polymer melt is heated to above ambient temperature before injection to allow it to flow, and the melt is maintained at this elevated temperature relative to ambient temperature during the injection step. Once sufficiently cooled, the polymer melt solidifies. Ambient temperature refers to typical room temperature, such as 15-25°C.

[0145] When the polymer is thermosetting, it can be heated in the injection unit to make it soft enough to flow, but the temperature will not trigger solidification. Alternatively, in liquid injection molding, the polymer can be a liquid mixture rather than a polymer melt, which solidifies within the mold, for example, by heating. The polymer can then be injected into the cavity of the mold. The injection of gas and the formation of the sealing components will be the same as for thermoplastics. However, the polymer is not allowed to cool and solidify. Instead, the mold is heated, for example, at a temperature of 80 to 200°C, to trigger solidification.

[0146] According to another aspect of the present invention, a breathing interface device manufactured by the above method is provided.

[0147] The sealing component of the breathing interface device can be fixed to the body of the breathing interface device by chemical or mechanical bonding, for example, through secondary injection molding or overmolding. The bond between the body and the sealing component can be permanent.

[0148] The patient contact surface of the sealing member can have a closed-loop shape. In use, the patient contact surface is typically aligned with the patient's forehead plane, but may include a convex surface in the cheek region of the patient contact surface and / or a concave surface in the nose and chin regions of the patient contact surface in the circumferential direction. The patient contact surface may include a convex surface in the transverse or radial direction. The circumferential convex surface of the patient contact surface may extend along a large portion of the mask's length. In use, the convex curvature and / or concave curvature can provide a varying position of the patient contact surface relative to the patient's sagittal axis.

[0149] The body portion of the breathing interface device may include a flow channel, such as defined by the mask body in a breathing mask and the airway tube in an endotracheal tube or laryngeal mask airway. A sealing member may be used to seal a surface of the patient's body, either an outer or inner surface, to form an effective seal with the patient's airway.

[0150] The breathing interface device can be a non-invasive interface device, wherein a sealing member seals a flow channel (e.g., the mask body) to the patient's face, thereby creating an effective fluid connection between the flow channel and the patient's mouth and / or nose. Alternatively, the breathing interface device can be an invasive interface device, wherein a sealing member seals a flow channel to the inner surface of the patient's airway, thereby creating an effective fluid connection between the device's flow channel (e.g., an airway tube) and the patient's airway.

[0151] The sealing member and / or patient contact surface may be configured as a continuous ring that extends around the inlet of the flow channel in the breathing interface device.

[0152] The breathing interface device may be a face mask, wherein the body portion of the breathing interface device defines a face mask body for receiving a nose or mouth and a sealing member for engaging with a patient's face, and may have the form of a sealing pad. The body portion of the breathing interface device may also include a connector for connecting the face mask body of the device to a breathing device such as a breathing tube and / or a supply device for breathing gas. The connector may be positioned at the other end of the flow channel defined by the face mask body relative to the end where the sealing member is located.

[0153] The breathing interface device can be an endotracheal tube or a supraglottic airway, such as a laryngeal mask airway, wherein the body portion of the breathing interface device defines the airway tube, and a sealing member for engaging with the patient's larynx or trachea, which may be in the form of a sealing cuff. The body portion of the breathing interface device may also include a connector for connecting the airway tube of the device to a respiratory device such as a breathing tube and / or a supply device for breathing gases. The connector may be positioned at the other end of the flow passage defined by the airway tube, relative to the end where the sealing member is located.

[0154] The sealing member may have one or more solid portions, i.e., portions without an internal chamber. The internal chamber may have a first end and a second end, which can be separated from the one or more solid portions of the sealing member. The internal chamber may include a tapered end adjacent to the solid portion of the sealing member.

[0155] According to another aspect of the invention, a breathing interface device is provided, comprising a body portion of the breathing interface device formed of a first polymer and a sealing member of the breathing interface device formed of a second polymer, the sealing member being fixed to the body portion of the breathing interface device, and the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface, wherein the internal chamber has one or more solid portions of the sealing member separating a first end and a second end.

[0156] The sealing component of the breathing interface device can be fixed to the body of the breathing interface device by chemical or mechanical bonding, for example, through secondary injection molding or overmolding. The bond between the body and the sealing component can be permanent.

[0157] Each solid portion of the sealing member may be a single continuous solid body of the second polymer. One or more solid portions of the sealing member separating the first and second ends of the internal chamber may be single continuous solid bodies of the second polymer.

[0158] One or more solid sections can provide greater deformation resistance to the breathing interface device in one or more selected areas. For example, one or more solid sections can provide greater deformation resistance to the sealing member of a breathing mask in one or more selected areas (e.g., the chin region), which can eliminate the need for a separate reinforcement structure. Similarly, one or more solid sections can provide greater deformation resistance to the distal region of the sealing cuff of a laryngeal mask airway, which can reduce the risk of the sealing cuff folding during insertion into the patient's airway and can eliminate the need for a separate reinforcement structure.

[0159] The breathing interface device may include a hole in the enclosure of the sealing member and / or in the wall of the body portion of the breathing interface device (e.g., the mask body), such that the hole is in fluid communication with the internal chamber of the sealing member of the breathing interface device, and ambient air can enter and exit the internal chamber during use. This feature can improve the compliance of the sealing member when pushed against a patient's surface during use, and thus improve the seal achieved with that surface.

[0160] According to another aspect of the invention, a breathing interface device is provided, comprising a body portion of the breathing interface device formed of a first polymer and a sealing member of the breathing interface device formed of a second polymer, the sealing member being fixed to the body portion of the breathing interface device, and the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface, wherein the breathing interface device includes a hole in the enclosure of the sealing member and / or in the wall of the body portion of the breathing interface device, such that the hole is in fluid communication with the internal chamber of the sealing member of the breathing interface device, and ambient air can enter and exit the internal chamber during use.

[0161] The breathing interface device according to this aspect of the invention includes a resiliently deformable enclosure comprising a patient contact surface providing an anatomically compatible fit with the patient, and an internal chamber and an orifice defined at least partially by the resiliently deformable enclosure through which ambient air can enter and exit the internal chamber. This combination of features provides the sealing member with an effective seal against the patient by virtue of its anatomical fit, but when a greater seal is required, the sealing member can also be pushed toward the patient, for example, toward the patient's face, by virtue of its internal chamber and the orifice through which ambient air can enter and exit the internal chamber during use. In particular, compared to prior art inflatable sealing members, the internal chamber and the orifice through which ambient air can enter and exit the internal chamber during use provide greater deformability to the resiliently deformable enclosure of a given thickness of the sealing member. This achieves a thicker wall than prior art inflatable sealing members that do not allow gas to exit the internal chamber during use, and this thicker wall can provide advantages including better maintenance of the anatomical shape during and after deformation, improved durability and reduced risk of damage, and the ability to achieve a sealing member that does not require re-inflating before use. Furthermore, compared to the non-inflatable sealing components of the prior art, this aspect of the invention reduces the risk of the sealing component opening and causing leakage when pressure is applied by a clinician.

[0162] The breathing interface device may be a breathing mask. The orifice may be normally open or open by air flowing into and out of the internal chamber of the sealing member. The orifice may not have any valve with a closing configuration. In some embodiments, the orifice may include a valve regulating the flow of ambient air into and out of the internal chamber of the sealing member. This valve may be a two-way valve. When the orifice is formed in the wall of the mask body of the breathing interface device and in any lower wall of the sealing member, the risk of the orifice becoming blocked during use can be reduced.

[0163] In this arrangement, the gas pressure within the internal chamber can be atmospheric pressure, and the walls can still have sufficient rigidity to maintain their shape during treatment, for example, unless sufficient pressure is applied to the patient's face during use.

[0164] If a user pushes the sealing member against the patient's surface, for example by applying pressure to the patient's surface at the breathing device interface, the sealing member and the internal chamber will be compressed, causing air to escape from the internal chamber. However, the stiffness of the sealing member is sufficient to prevent the internal chamber from completely collapsing during compression, i.e., to remain separated between the opposing inner surfaces of the enclosure, and once the pressure is removed, the stiffness of the sealing member is sufficient to allow the enclosure and the internal chamber to return to their original shape.

[0165] According to another aspect of the invention, there is a breathing interface device comprising a body portion of the breathing interface device formed of a first polymer and a sealing member of the breathing interface device formed of a second polymer, the sealing member being fixed to the body portion of the breathing interface device, and the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface, wherein the patient contact surface provides anatomical fit with a patient.

[0166] According to another aspect of the invention, there is a breathing circuit that includes a breathing gas supply device, a patient interface device as defined above, and a breathing tube extending between the breathing gas supply device and the patient interface device.

[0167] Practical embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, wherein:

[0168] Figure 1 This is a rear view of the mask body formed during the first injection of the secondary injection molding method according to the first embodiment of the present invention.

[0169] Figure 2 This is a schematic diagram of the first stage of the second injection in the secondary injection molding method according to the first embodiment of the present invention, wherein the polymer melt for the second injection is being introduced.

[0170] Figure 3 This is a schematic diagram of the second stage of the second injection in the secondary injection molding method according to the first embodiment of the present invention, wherein the polymer melt of the second injection has been fully introduced;

[0171] Figure 4 This is a schematic diagram of the third stage of the second injection in the secondary injection molding method according to the first embodiment of the present invention, wherein gas is partially introduced into the polymer melt of the second injection.

[0172] Figure 5 This is a schematic diagram of the fourth stage of the second injection in the secondary injection molding method according to the first embodiment of the present invention, wherein gas is completely introduced into the polymer melt of the second injection.

[0173] Figure 6 The breathing mask is formed by a secondary injection molding method according to a first embodiment of the present invention, wherein a polymer for the second injection and a gas inlet are shown.

[0174] Figure 7 This is a first perspective view of a breathing mask formed by a secondary injection molding method according to a second embodiment of the present invention; and

[0175] Figure 8This is a second perspective view of a breathing mask formed by a secondary injection molding method according to a second embodiment of the present invention.

[0176] Figure 1-6 The method shown in the first embodiment of the present invention is a secondary injection molding method for manufacturing a breathing mask.

[0177] Injection molding processes typically involve equipment comprising injection units, each including an exit nozzle, a tooling unit defining the mold, and a clamping unit. The clamping unit is arranged to move the molding tooling assembly between a closed configuration, in which polymer melt can be injected into the mold cavity, and in the open configuration, the molded article can be removed from the mold.

[0178] The mold tool defines a mold having a first cavity and a second cavity, each cavity having a polymer injection port for introducing polymer melt into the cavity, and each cavity being defined by an inner wall of the mold.

[0179] The first injection unit for the first injection in the secondary injection molding method is provided with a first polymer melt, which in this embodiment is polypropylene (PP), a thermoplastic. The first polymer melt is heated in the injection unit until it is sufficiently soft to flow, and the outlet nozzle of the injection unit is moved to engage and fluidly communicate with the injection port of the first cavity of the mold.

[0180] Furthermore, the second injection unit for the second injection in the secondary injection molding method is provided with a second polymer melt, which in this embodiment is a thermoplastic elastomer (TPE), a thermoplastic plastic. The second polymer melt is heated in the second injection unit until it is soft enough to flow, and the outlet nozzle of the second injection unit is moved to engage and fluidly communicate with the injection port of the second cavity of the mold.

[0181] In the first injection of the method according to a first embodiment of the invention, the mold is moved to a first injection configuration of the mold. Then, a first injection unit, for example using a piston and cylinder assembly (which may also be referred to in the art as a screw and barrel assembly), applies pressure to a first polymer melt and injects the first polymer melt through an outlet nozzle and a polymer injection port into a first cavity of the mold. The polymer melt within the first cavity is then allowed to begin cooling while maintaining the pressure applied to the polymer melt until the polymer melt partially solidifies.

[0182] The polymer melt injected into the first cavity takes the form of a mask body 10. This mask body is shown in... Figure 1 The mold is not shown in the image for clarity.

[0183] The mask body 10 includes a peripheral edge 16 and a tapered wall 12 extending forward and inward from the peripheral edge 16 to a tubular connector 14. The tubular connector 14 is a conventional male or female cylindrical connector, for example, 22 mm in diameter, for connection to a breathing circuit. The tapered wall 12 is typically dome-shaped, having a mouth portion with a generally annular cross-section in a plane corresponding to the patient's facial plane (i.e., the forehead plane) during use, and a generally triangular, narrow nose portion with a rounded apex for engagement with the patient's nasal bridge. Figure 1 In the mask body shown, the nose portion of the conical wall 12 also includes a narrowing portion along the longitudinal axis of the mask body, which extends from the tubular connector 14 toward the circular apex of the nose portion of the conical wall 12. This narrowing portion of the conical wall 12 defines a side surface that can be gripped by a user (e.g., in a pinching motion).

[0184] Once the mask body 10 has been partially cured in the first injection of the secondary injection molding method, the mold is then moved to the second injection configuration such that the second cavity of the mold is in fluid communication with the boundary region of the outer periphery 16 of the mask body 10 and the surface of the mask body 10 adjacent to the outer periphery 16.

[0185] In the second injection of the method according to the first embodiment of the present invention, while the mask body 10 remains in a partially solidified state, the second injection unit applies pressure to the polymer melt, for example using a piston and cylinder device, and injects the second polymer melt through an outlet nozzle and a polymer injection port into the second cavity of the mold. Before applying pressure and injecting into the second cavity of the mold, a foaming agent can be mixed with the second polymer melt in the second injection unit, which ensures a more uniform process of the injected gas through the mold cavity. This method is further described in UK Patent Application No. 2013108.2.

[0186] Figure 2 The second polymer melt 20, partially introduced into the second cavity, is shown, and Figure 3 The second polymer melt 20 is shown being fully introduced into the second cavity. (See image.) Figure 3 As shown, the second polymer melt 20 only partially fills the second cavity, and therefore the volume of the second polymer melt 20 is smaller than the volume of the second cavity. Since the polymer injection port 28 for the second cavity is located at the apex of the nose portion of the mask body 10 (see...), Figure 6 The second cavity extends from the polymer injection port 28 around the outer edge 16 of the mask body 10 in two directions, and the second polymer melt 20 flows from the polymer injection port 28 along the second cavity in the two branches 21, 22 and extends substantially the same distance into the second cavity in each branch 21, 22.

[0187] Once the second polymer melt 20 is fully introduced into and partially fills the second cavity, nitrogen gas 30 is introduced into the second polymer melt 20 within the second cavity through the inlet 38 (see...). Figure 6 The air inlet 38 is located adjacent to and perpendicular to the polymer injection port 28 of the second cavity. The air inlet 38 extends from the wall of the second cavity to the central region of the second cavity, causing the gas to form bubbles within the second polymer melt 20 in the second cavity.

[0188] Since the air inlet 38 is also located at the apex of the nose portion of the mask body 10, and the second cavity extends from the air inlet 38 around the outer peripheral edge 16 of the mask body 10 in two directions, the gas bubbles 30 flow from the air inlet 38 along the central axis of the second polymer melt 20 in the second cavity in the two branches 31, 32.

[0189] Figure 4 This shows that gas 30 is partially introduced into the second polymer melt 20 within the second cavity. Figure 5 This shows that the gas is completely introduced into the second polymer melt 20 of the second cavity.

[0190] like Figure 4 and 5 As shown, the introduction of gas 30 causes the second polymer melt 20 to move further along the second cavity toward the chin region of the mask body 10 until the two branches 21, 22 of the second polymer melt 20 meet, mix, and engage in the chin region of the mask body 10. In this embodiment, the gas 30 introduced into the second polymer melt 20 within the second cavity is sufficient to form a thin-walled sealing pad 42 with an inflatable internal chamber 44. However, the gas 30 introduced into the second polymer melt 20 within the second cavity remains in the two branches 31, 32 and does not meet in the chin region of the mask body 10. Instead, the two branches 31, 32 of the inflatable internal chamber 44 each terminate with a tapered end, each tapered end being disposed on each side of the solid portion of the second polymer melt, i.e., the portion of the second polymer melt not containing the inflatable interior, which forms the chin region 46 of the sealing pad 42.

[0191] Once the sealing gasket 42 of the respirator has been formed, the mask body 10 and the sealing gasket 42 are allowed to cool and fully solidify while maintaining the pressure applied to the polymer melt by the gas 30. This bonds a second polymer to the boundary region and outer edge of the mask body 10, thus binding the mask body 10 and the sealing gasket 42 together. Therefore, no additional assembly steps (such as gluing) are required to hold the mask body 10 and the sealing gasket 42 together.

[0192] The second cavity of the mold is shaped to provide an anatomical shape for the sealing pad 42 of the breathing mask, which is configured to correspond to the facial contours around the patient's nose and mouth.

[0193] The sealing gasket 42 of the respirator includes a thin wall surrounding the inflatable internal chamber 44. Furthermore, since the air inlet 38 extends from the wall of the second cavity into the central region of the second cavity, the wall of the sealing gasket 42 is formed around the air inlet 38, which provides an opening in the wall of the sealing gasket 42 when the respirator is removed from the mold. This opening in the wall of the sealing gasket 42 provides fluid communication between the inflatable internal chamber 44 of the sealing gasket 42 and ambient air.

[0194] Figure 7 and Figure 8 This shows a respirator 100 formed by a secondary injection molding method according to a second embodiment of the present invention. Except for the location of the hole 138 formed by the air inlet 38, this respirator 100 is the same as those respirators formed by the first embodiment of the present invention as described above.

[0195] In a breathing mask 100 formed according to a second embodiment of the method of the invention, the hole 138 formed by the air inlet is located in the mask body 112 and in the lower wall of the sealing pad 142, rather than in the deformable wall of the sealing pad 142 extending from the mask body 112. This location of the hole 138 is achieved by providing a mold in which, in a second injection configuration of the mold, the air inlet 38 extends from the wall of the first cavity of the mold and enters into the central region of the second cavity. In this arrangement, when a first polymer is injected into the first cavity of the mold to form the mask body 112, the mask body 112 is formed around the air inlet 38. In the second injection configuration of the mold, the air inlet 38 extends through the mask body 112 in the first cavity and protrudes into the second cavity. In this arrangement, when a second polymer is injected into the second cavity of the mold to form the sealing pad 142, the wall of the sealing pad 142 located below the adjacent wall of the mask body 112 is formed around the air inlet 38. When the breathing mask 100 is removed from the mold, a hole 138 is thus formed in the mask body 112 of the breathing mask 100 and in the wall below the sealing gasket 142. The hole 138 provides fluid communication between the inflatable internal chamber of the sealing gasket 42 of the breathing mask 100 and the ambient air.

[0196] In a third embodiment of the method according to the invention, an overmolding process is used. This differs from the first and second embodiments, which are secondary injection molding processes, in that, typically once substantially or completely cured, the mask body (substrate) formed of the first polymer is transferred to a second cavity in a second mold, and then the second polymer is injection molded into the second cavity, thus "overmolding" the mask body. In this embodiment, the sealing member formed of the second polymer is fixed to the mask body formed of the first polymer by one or more of chemical bonding and mechanical bonding.

[0197] Furthermore, any of the first, second, and third embodiments can also be used with thermosetting polymers, for example, for sealing components. For instance, liquid silicone rubber (LSR) can be a second polymer used to form the sealing component. However, when using thermosetting polymers, the injection molding steps and associated equipment will differ from those described above because thermosetting polymers typically require heating to initiate curing. For liquid silicone rubber, liquid injection molding (LIM) is typically used.

[0198] The materials commonly used in the LIM process are silicone and acrylic resins. Using a pump, the LIM process combines a base plastic and a catalyst that can be reinforced with additives and fibers. For example, each is pumped into a static mixer in a 1:1 ratio, triggering a mixing reaction to form liquid silicone rubber (LSR). The outlet nozzle of the injection unit is moved to engage and fluidly communicate with the injection port of the mold cavity.

[0199] The liquid mixture is then injected into the cavity of the mold. Gas injection and the formation of the sealing components are the same as for the thermoplastics described above. However, the polymer is not allowed to cool and cure. Instead, the mold is heated, for example at a temperature of 80 to 200°C, to initiate curing. Once the polymer has cured, the breather port device can be removed from the mold.

Claims

1. A method for manufacturing a sealing member for a breathing interface device, the method comprising the following steps: (a) Provide a mold with a cavity, a polymer injection port and an air inlet; (b) Injecting the polymer into the cavity of the mold through the polymer injection port; as well as (c) Gas is introduced into the cavity of the mold through the air inlet, thereby forming a sealing member of the breathing interface device. The sealing member of the breathing interface device includes an internal chamber defined at least partially by an elastically deformable enclosure formed of the polymer, the enclosure including a patient contact surface having a shape defined by the cavity of the mold and providing anatomical fit with the patient, wherein the internal chamber has a first end and a second end separated by one or more solid portions of the sealing member.

2. The method according to claim 1, wherein, The patient contact surface has a guide portion that is the portion of the surface that contacts the patient before any deformation of the sealing member occurs. The guide portion is anatomically shaped at least in the engagement direction between the sealing member and the patient's surface, such that the position of the guide portion of the patient contact surface varies in that direction at different locations along the patient contact surface.

3. The method according to claim 2, wherein, The guide portion of the patient contact surface and / or the centerline on the guide portion have a varying position relative to a reference surface, the reference surface being a reference plane or a reference cylinder, wherein the reference surface is arranged perpendicular to the engagement direction between the sealing member and the patient's surface, or the direction of the overall pressure applied by the sealing member to the patient's surface.

4. The method according to claim 1, wherein, The air inlet of the mold is connected to a gas source, and the gas has a pressure sufficient to guide, deform, and / or move the polymer within the cavity of the mold to form the sealing member.

5. The method according to claim 1, wherein, The air inlet of the mold protrudes into the cavity and has an outlet opening for entering the cavity, through which the gas enters the cavity, the outlet opening being separate from the surrounding inner surface of the mold that defines the cavity.

6. The method according to claim 1, wherein, The air inlet protrudes relative to the inner surface of the mold defining the cavity, which results in a hole being formed in the enclosure of the sealing member, the hole being in fluid communication with the internal chamber of the sealing member.

7. The method according to claim 1, wherein, The polymer is injected into the cavity of the mold through the polymer injection port, such that the cavity of the mold is only partially filled.

8. The method according to claim 7, wherein, The polymer injected into the cavity of the mold has a volume smaller than the volume of the cavity, such that after the polymer is injected but before the gas is introduced, the polymer extends only partially along the cavity in a monolithic form, separating from the end of the cavity opposite to the end where the polymer injection port is located.

9. The method according to claim 1, wherein, When the cavity of the mold is at least partially filled with the polymer, the gas is introduced into the cavity of the mold through the air inlet.

10. The method according to claim 1, wherein, The internal cavity, at least partially defined by an elastically deformable enclosure formed of the polymer, is formed in the sealing member within the cavity of the mold.

11. The method according to claim 1, wherein, The polymer injection port for the cavity is disposed at one end of the sealing member during manufacturing, and the sealing member is formed by the polymer flowing from the polymer injection port along the cavity in two directions.

12. The method according to claim 1, wherein, The gas applies pressure to the polymer to form the internal chambers and surrounding walls of the polymer, and The pressure applied by the gas has a radial component that guides, deforms, or moves the polymer outward toward the inner surface of the cavity to form the enclosure of the sealing member, and / or the pressure applied by the gas has an axial component that guides, deforms, or moves the polymer axially along the cavity away from the air inlet.

13. The method according to claim 1, wherein, The air inlet is located at one end of the sealing member during manufacturing, and the internal cavity is formed by the gas flowing from the air inlet through the polymer along the cavity in two directions.

14. The method according to claim 1, wherein, The polymer moves from the polymer injection port and / or the air inlet along the cavity in opposite directions, wherein the cavity has a closed-loop shape such that the polymer has two branches that advance along the cavity.

15. The method according to claim 1, wherein, The solid portion is located at the end of the cavity opposite to the air inlet.

16. A sealing member for a breathing interface device manufactured by the method according to any one of claims 1 to 15.

17. The sealing member according to claim 16, wherein, The sealing member includes an internal cavity defined at least partially by an elastically deformable enclosure wall, the enclosure wall including a patient contact surface having a morphology that provides anatomical fit with a patient, wherein the sealing member includes an opening in fluid communication with the internal cavity of the sealing member and with ambient air, such that ambient air can enter and exit the internal cavity during use.

18. The sealing member according to claim 16 or claim 17, wherein, The sealing member is used for a breathing mask, and the patient contact surface is generally aligned with the patient's forehead plane during use, but includes a convex surface in the cheek region of the patient contact surface in the circumferential direction, and / or a concave surface in the nose and / or chin region of the patient contact surface.

19. The sealing member according to claim 17, wherein, An opening is provided in the enclosure of the sealing member, the opening being in fluid communication with the internal chamber of the sealing member and with ambient air, such that ambient air can enter and exit the internal chamber during use.

20. The sealing member according to claim 19, wherein, The orifice includes a valve that regulates the inflow and outflow of ambient air into and out of the internal chamber of the sealing member, the valve being opened by the air flowing into and out of the internal chamber of the sealing member.

21. The sealing member according to claim 16, wherein, The one or more solid portions are portions without internal chambers.

22. The sealing member according to claim 21, wherein, The one or more solid portions of the sealing member separating the first and second ends of the internal chamber are composed of a single continuous solid portion.

23. The sealing member according to claim 21, wherein, The sealing member is used for a breathing mask, and the one or more solid portions provide greater resistance to deformation of the sealing member in one or more selected regions including the chin region.

24. The sealing member according to claim 21, wherein, The sealing member is used for the laryngeal mask airway, and the one or more solid portions can provide greater resistance to deformation at the tip region of the sealing sleeve of the laryngeal mask airway.

25. A method of manufacturing a breathing interface device, the method comprising a method of manufacturing a sealing member for the breathing interface device according to any one of claims 1 to 15.

26. A method for manufacturing a breathing interface device, the method comprising the following steps: (a) Providing one or more molds, the one or more molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port, and an air inlet for entering the second cavity; (b) Injecting a first polymer into the first cavity of the mold through the first polymer injection port to form the body portion of the breathing interface device; (c) Injecting a second polymer into the second cavity of the one or more molds through the second polymer injection port, and introducing gas into the second cavity of the one or more molds through the air inlet to form a sealing member of the breathing interface device, the sealing member comprising an internal chamber defined at least partially by an elastically deformable enclosure formed of the second polymer, the enclosure including a patient contact surface, wherein the patient contact surface has a morphology defined by the second cavity of the one or more molds and providing anatomical fit with a patient, wherein the internal chamber has a first end and a second end, the first end and the second end being separated by one or more solid portions of the sealing member; and The body portion and the sealing member of the breathing interface device can be formed in any order, such that either the body portion or the sealing member is an earlier formed portion, and the other of the body portion and the sealing member is a later formed portion, and during the injection molding process of the later formed portion, the later formed portion is joined to the earlier formed portion in a manner that fixes the body portion and the sealing member of the breathing interface device together.

27. The method according to claim 26, wherein, The method includes a method for manufacturing a sealing member for a breathing interface device according to any one of claims 1 to 15.

28. The method according to claim 26 or claim 27, wherein, The body portion of the breathing interface device is the earlier formed portion, and the sealing member of the breathing interface device is the later formed portion.

29. The method according to claim 26, wherein, The one or more molds may be arranged such that the earlier formed portion of the breathing interface device can be located near or inside the cavity (first or second cavity) for forming the later formed portion of the breathing interface device, such that during the injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that secures the body portion of the breathing interface device and the sealing member together.

30. The method according to claim 29, wherein, During the injection molding process of the later-formed portion, the later-formed portion comes into contact with the earlier-formed portion.

31. The method according to claim 26, wherein, The one or more molds include a mold having a first injection configuration defining a first cavity and a first polymer injection port, and a second injection configuration defining a second cavity, a second polymer injection port, and an air inlet for entering the second cavity, such that in the first injection configuration, the first polymer is injected into the first cavity of the mold through the first polymer injection port to form the body portion of the breathing interface device, and in the second injection configuration, the body portion of the breathing interface device is disposed near the second cavity, and the second polymer is injected into the second cavity of the mold through the second polymer injection port, and the gas is introduced into the second cavity of the mold through the air inlet to form the sealing member of the breathing interface device, and during the injection molding of the sealing member, the sealing member is engaged with the body portion in a manner that secures the body portion of the breathing interface device and the sealing member together.

32. The method according to claim 26, wherein, The one or more molds include a first mold having a first cavity and a first polymer injection port, and a second mold having a second cavity, a second polymer injection port, and an air inlet for entering the second cavity, such that the first polymer is injected into the first cavity of the first mold through the first polymer injection port to form the body portion of the breathing interface device, and then the body portion of the breathing interface device is transferred to the second mold such that the body portion of the breathing interface device is disposed inside or near the second cavity, and the second polymer is injected into the second cavity of the second mold through the second polymer injection port, and the gas is introduced into the second cavity of the second mold through the air inlet to form the sealing member of the breathing interface device, and during the injection molding of the sealing member, the sealing member is engaged with the body portion in a manner that fixes the body portion of the breathing interface device and the sealing member together.

33. The method according to claim 26, wherein, The second polymer contacts the boundary region of the body portion of the breathing interface device.

34. The method according to claim 26, wherein, During manufacturing, an opening is formed around the air inlet to enter the internal chamber, and the opening allows ambient air to enter and exit the internal chamber during use.

35. The method according to claim 34, wherein, The pores are formed in the elastically deformable enclosure formed of the second polymer.

36. The method according to claim 34, wherein, The internal cavity is at least partially defined by a wall having a first layer defined by the first polymer and a second layer defined by the second polymer, and the opening for entering the internal cavity is formed in the wall.

37. The method of claim 34, wherein, The air inlet protrudes relative to the inner surface of the mold defining the first cavity or the second cavity, which causes the hole to be formed in the body portion of the breathing interface device and / or in the enclosure of the sealing member of the breathing interface device.

38. The method according to claim 34, wherein, The air inlet protrudes into the second cavity through the body portion of the breathing interface device.

39. A breathing interface device manufactured by the method according to any one of claims 25 to 38.

40. A breathing interface device comprising a sealing member according to any one of claims 16 to 24.

41. The breathing interface device according to claim 40, manufactured by the method according to any one of claims 25 to 38.

42. A breathing circuit comprising a breathing gas supply device, a breathing interface device according to any one of claims 39 to 41, and a breathing tube extending between the breathing gas supply device and the patient interface device.

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