Improvements to respiratory interface devices

Abstract

To provide a manufacturing method for a sealing member for a respiration interface device.SOLUTION: A manufacturing method for a sealing member for a respiration interface device includes the steps of: (a) providing a mold having a cavity, a polymer injection port, and a gas inlet port, (b) injecting a polymer into the cavity of the mold via the polymer injection port; and (c) introducing gas into the cavity of the mold via the gas inlet port, thereby forming a sealing member for the respiration interface device. The sealing member for the respiration interface device includes an internal chamber 44 at least partially surrounded by an elastically deformable surrounding wall formed of the polymer. The surrounding wall includes a patient-contacting surface. The patient-contacting surface has a shape which is determined by the cavity of the mold and brings about an anatomical fit with a patient.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to a respiratory interface device and a related manufacturing method.

Background Art

[0002] To connect a breathing apparatus to a patient's respiratory system, the breathing apparatus generally includes some form of respiratory interface device. There is a wide range of different interface devices, including non-invasive interface devices such as face masks and nasal masks, and invasive interface devices such as endotracheal tubes and supraglottic airways like laryngeal mask airways.

[0003] Many of these interface devices are configured to seal against the surface of the patient's body, which can be either the outer surface or the inner surface, in order to form an effective seal with the patient's airway. For example, non-invasive interface devices generally include a sealing member that seals the device against the patient's face and forms an effective connection between the device and the patient's mouth and / or nose, and invasive interface devices often include a sealing member that seals the device against the inner surface of the patient's airway and forms an effective connection between the device and that airway.

[0004] Many of these respiratory interface devices include an inflatable sealing member, such as a sealing cushion or a sealing cuff, which is formed by a thin enclosing wall surrounding an internally gas-filled chamber.

[0005] An example of a respiratory interface device is an anesthetic mask. An anesthetic mask is a breathing mask held to cover a patient's nose and mouth while delivering anesthetic gas to the patient. These masks generally consist of a mask body with a tubular connector that connects to a source of anesthetic gas, and an inflatable sealing cushion extending around the periphery of the inlet to the mask body. The walls of the inflatable sealing cushion are thin, and sufficient pressure of gas exceeding atmospheric pressure is required inside the sealing cushion to maintain its shape and be elastically deformable. The sealing cushion generally includes an inlet with a one-way valve that allows for inflation of the sealing cushion. The sealing cushion can also be deflated using a syringe. When in use, a conventional anesthetic mask with an inflated sealing cushion is positioned to cover the patient's nose and mouth and is biased against the patient's face until a sufficient seal is obtained to deliver anesthetic gas to the patient. However, a considerable amount of pressure may be required to achieve an acceptable seal.

[0006] A further significant drawback of respiratory interface devices that include inflatable parts is the manufacturing cost, which generally requires an assembly step to attach the inflatable part to the rest of the device and, in many devices, an additional step to provide a valve that allows the inflatable part to inflate. Specifically, blow molding is commonly used to form the inflatable sealing member, which is then bonded to the main body, such as a more rigid mask body. Blow molding uses either a pre-formed insert with a hollow interior that is inflated in a mold in a process called injection blow molding, or an extruded parison tube that is clamped at each end and inflated in a mold in a process called extrusion blow molding.

[0007] An alternative approach to the use of inflatable portions in respiratory interface devices is to provide anatomically shaped, flexible sealing members to achieve an effective seal with the patient, such as the patient's face. These devices can be formed using a two-shot injection molding process, which reduces assembly steps compared to the manufacture of respiratory interface devices with inflatable portions. Generally, these masks require less pressure to achieve an acceptable seal. However, these devices have the drawback that if an acceptable seal is not achieved, the sealing cushion or sealing cuff may become less adaptable to the patient's face when increased pressure is applied, and there is a risk that the sealing member may deform and expand under pressure, resulting in leakage. [Overview of the project] [Problems that the invention aims to solve]

[0008] Herein, an improved method for manufacturing a respiratory interface device and an improved respiratory interface device have been devised that overcome or substantially mitigate the above-mentioned shortcomings and / or other shortcomings associated with the prior art. [Means for solving the problem]

[0009] According to a first aspect of the present invention, a method for manufacturing a sealing member for a respiratory interface device is provided. This method is (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting the polymer into the cavity of the mold through the polymer injection port, (c) The step of introducing gas into the cavity of the mold via the gas introduction port, Includes, This forms a sealing member for the respiratory interface device, The sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, the enclosure wall including a patient contact surface, the patient contact surface having a shape determined by the cavity of the mold, which provides an anatomical fit with the patient.

[0010] The method according to the present invention provides a sealing member for a respiratory interface device, comprising an internal chamber at least partially enclosed by an elastically deformable enclosure wall defined by a polymer, and thus capable of functioning similarly to the inflatable portion of a prior art device; and an enclosure wall that includes a patient contact surface having a shape determined by a mold cavity and providing an anatomical fit with the patient, and thus capable of being configured to function similarly to an anatomically shaped sealing membrane of the prior art. This combination of features makes it possible to form a sealing member that provides an effective seal with the patient by its anatomical fit, but if it is necessary to improve the seal, the sealing member can also be biased against the patient, for example, the patient's face, by its internal chamber.

[0011] The patient contact surface can provide an anatomical fit with the patient before the sealing member deforms during use; that is, the patient contact surface can be anatomically shaped. To provide an anatomical fit, the patient contact surface can have a leading portion, i.e., the portion that contacts the patient's surface before the sealing member deforms, and this leading portion is anatomically shaped. This anatomical shape is determined at least in the direction in which the sealing member engages with the patient's surface, thereby the position of the leading portion of the patient contact surface can vary in this direction at different positions along the patient contact surface, for example. The leading portion of the patient contact surface can have the shape of a closed loop extending around, for example, the mask body of a respiratory mask, or the airway tube of a laryngeal mask squareway or endotracheal tube. The leading portion of the patient contact surface and / or the centerline on the leading portion can have a position that varies with respect to a reference plane, such as a reference plane or reference cylindrical plane, where the reference plane can be positioned perpendicular to the direction in which the sealing member engages with the patient's surface, or the direction of the overall pressure applied to the patient's surface by the sealing member. The leading edge of the patient contact surface and / or the centerline on the leading edge may have a position that changes non-linearly with respect to the reference plane.

[0012] The mold's gas introduction port can be connected to a gas source, which may include a controller that determines the volume, pressure, temperature, and / or time for gas introduction. The gas can have sufficient pressure to induce, deform, and / or move the polymer to form a sealing member within the mold cavity. For example, the gas can be injected via the gas introduction port, or supplied from a compression source. If the gas is supplied by a compression source, the gas can be nitrogen or another sufficiently inert gas.

[0013] The gas introduction port of the mold can protrude into the cavity, for example, in the form of a nozzle. The gas introduction port can protrude relative to the inner circumferential surface of the mold that defines the cavity. The gas introduction port may have an outlet opening to the cavity, through which the gas enters the cavity. When the sealing member is fitted to a patient, the longitudinal axis of the sealing member can coincide with the longitudinal axis of the patient. In the case of a sealing member for a breathing mask, the gas introduction port can be positioned at the end of the cavity corresponding to the apex of the nose portion of the sealing member for the breathing mask.

[0014] The gas introduction port outlet opening can be formed in the mold wall. The outlet opening can be positioned away from the inner circumferential surface of the mold that defines the cavity. The outlet opening can be positioned approximately in the center of the cavity's cross-section, for example, within the range of 35-65% of the longest dimension of the cavity's cross-section. The cross-section refers to the cavity surface oriented approximately perpendicular to the central axis of the cavity, which extends in a loop along the center of the cavity.

[0015] The gas introduction port can protrude from the inner circumferential surface of the mold defining the cavity, thereby forming an opening in the enclosure wall of the sealing member. This opening can be used to establish fluid communication with the internal chamber of the sealing member.

[0016] A further aspect of the present invention provides a method for manufacturing a sealing member for a respiratory interface device. This method is (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting the polymer into the cavity of the mold, (c) The step of introducing gas into the cavity of the mold via the gas introduction port, Includes, This forms a sealing member for the respiratory interface device, The sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, the enclosure wall including a patient contact surface, and the gas introduction port protrudes toward the inner circumferential surface of the mold defining the cavity, thereby forming an opening in the enclosure wall of the sealing member.

[0017] The opening can be made to communicate fluidly with the internal chamber of the sealing member.

[0018] In a respiratory mask, an opening in the sealing member can provide fluid communication between the internal chamber of the sealing member and the ambient air. In invasive respiratory interface devices such as laryngeal mask squareways, an opening in the sealing member can provide fluid communication between the internal chamber of the sealing member and the gas source for inflating the sealing member.

[0019] The gas introduction port for the cavity can be positioned adjacent to the polymer injection port for the cavity.

[0020] The polymer injected into the mold cavity may have a volume smaller than the volume of the cavity. During injection, the polymer is soft enough to flow, for example, in the form of a polymer molten state. After injection but before gas introduction, the polymer may only partially stretch along the cavity. At this point, the polymer may have the form of a single structure separated from the end of the cavity opposite to the end where the polymer injection port is located.

[0021] During manufacturing, a polymer injection port for the cavity can be positioned at one end of the sealing member, and the polymer can be formed by flowing in both directions from the polymer injection port along the cavity.

[0022] The injected gas can induce, 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 an internal chamber and the surrounding wall of the polymer. The pressure applied by the gas can have a radial component that induces, deforms, or moves the polymer outward toward the inner surface of the cavity, thereby forming the surrounding wall of the sealing member. The pressure applied by the gas can have an axial component that induces, deforms, or moves the polymer axially along the cavity away from the gas introduction port.

[0023] The step of introducing gas into the mold cavity through the gas introduction port can form gas bubbles in the polymer that extend from the gas introduction port. The gas introduction port can be disposed at one end of the sealing member during manufacture, and the internal chamber can be formed by the gas flowing in both directions along the cavity through the polymer from the gas introduction port. However, other configurations including multiple gas introduction ports in different regions of the cavity may also be used.

[0024] The internal chamber can be filled with gas during manufacture. The thickness of the formed surrounding wall can be less than 4 mm, less than 3 mm, or less than 2.5 mm. The surrounding wall can have a substantially uniform thickness over at least most of the internal chamber, such as a variation of less than 20% from the average thickness over at least 80% of the surface area of the surrounding wall.

[0025] Also, the gas introduced into the cavity can move the polymer along the cavity toward, for example, the end of the cavity opposite the end where the polymer injection port and / or the gas introduction port is disposed.

[0026] The polymer can be moved along the cavity, which has a closed-loop shape, in the direction opposite to the polymer injection port and / or gas introduction port, thereby giving the polymer two branches that advance along the cavity. The polymer branches can merge, join, and bond to form a sealing member of the breathing interface device that extends along the closed loop.

[0027] 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 gas introduction port. Thus, the internal chamber formed by the injected gas may have a first end and a second end, separated by a continuous solid polymer, for example, at the end of a breathing interface device opposite the gas introduction port. The internal chamber may include a tapered end adjacent to the solid portion of the sealing member.

[0028] The solid portion can provide greater deformation resistance in one or more selected areas of the sealing member. For example, the solid portion can provide greater deformation resistance in one or more selected areas of the sealing member of a respiratory mask, such as the jaw area, thereby eliminating the need to form additional reinforcement. Similarly, the solid portion can provide greater deformation resistance in the tip area of ​​the sealing cuff of a laryngeal arma squareway, thereby reducing the risk of the sealing cuff breaking during insertion into the patient's airway and eliminating the need to form additional reinforcement.

[0029] One or more additional gas introduction ports can be provided to allow the introduction of a gas having a pressure that equilibrium with the movement of the polymer along the cavity. As the polymer moves along the cavity, the gas introduced through one or more additional gas introduction ports can be discharged.

[0030] The internal chamber can be filled with gas during manufacturing, and this gas can be replaced with ambient air after the sealing member is removed from the mold. The sealing member may include openings or fluid passages that allow gas or ambient air to enter or exit the internal chamber.

[0031] The mold may include a polymer injection port for the cavity. The injection molding step may include an injection unit. The injection unit may be configured to heat the polymer until it is soft enough to flow, thereby forming a polymer molten mass, and to move the injection unit to engage with the injection port in the mold cavity and establish fluid communication with it. The injection unit can then apply pressure to the polymer molten mass and inject it into the mold cavity through the polymer injection port. If the polymer is a thermoplastic resin, the polymer molten mass in the cavity is cooled to solidify the polymer. If the polymer is thermosetting, the polymer can be heated in the injection unit to a temperature soft enough to flow but not yet curing, thereby heating the polymer molten mass in the cavity to initiate curing of the polymer. Alternatively, in liquid injection molding, the polymer may be a liquid mixture that can be kept below room temperature in the injection unit, rather than a polymer molten mass, and this can be cured in the mold, for example, by applying heat.

[0032] A further aspect of the present invention provides a method for manufacturing a sealing member for a respiratory interface device. This method is (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting the polymer into the cavity of the mold through the polymer injection port, (c) The step of introducing gas into the cavity of the mold via the gas introduction port, Includes, This forms the sealing member for the respiratory interface device, As a result, an internal chamber, at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, is formed within the sealing member in the cavity of the mold, and the enclosure wall includes a patient contact surface that provides an anatomical fit with the patient.

[0033] A further aspect of the present invention provides a method for manufacturing a sealing member for a respiratory interface device. This method is (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting the polymer into the cavity of the mold through the polymer injection port, (c) 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 gas introduction port, Includes, This forms the sealing member for the respiratory interface device, The sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, the enclosure wall including a patient contact surface that provides an anatomical fit with the patient.

[0034] A further aspect of the present invention provides a method for manufacturing a sealing member for a respiratory interface device. This method is (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting a polymer into the cavity of the mold via the polymer injection port such that the cavity of the mold is only partially filled, (c) 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 gas introduction port, Includes, This forms the sealing member for the respiratory interface device, As a result, the internal chamber is at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, the enclosure wall including a patient contact surface that provides an anatomical fit with the patient.

[0035] A further aspect of the present invention provides a sealing member manufactured by any of the methods defined above.

[0036] A further aspect of the present invention provides a sealing member for a respiratory interface device, the sealing member comprising an internal chamber at least partially enclosed by an elastically deformable enclosure wall, the enclosure wall comprising a patient contact surface having a shape that provides an anatomical fit with the patient, and the sealing member comprising an opening of the sealing member that is in fluid communication with the internal chamber and ambient air, thereby allowing ambient air to enter and exit the internal chamber during use.

[0037] A sealing member according to this aspect of the present invention comprises an elastically deformable enclosure wall including a patient contact surface that provides an anatomical fit with the patient, an internal chamber at least partially enclosed by the elastically deformable enclosure wall, and an opening that allows ambient air to enter and exit the internal chamber during use. This combination of features provides the sealing member with an effective seal to the patient through its anatomical fit, but if the seal needs to be improved, the internal chamber and the opening that allows ambient air to enter and exit the internal chamber during use can also bias the sealing member towards the patient, for example, the patient's face. In particular, the internal chamber and the opening that allows ambient air to enter and exit the internal chamber during use can give the sealing member greater deformability for a given thickness of the elastically deformable enclosure wall compared to conventional inflatable sealing members. This allows for a thicker wall thickness than conventional inflatable sealing members that do not release gas from the internal chamber during use, and this thicker wall thickness 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 provide a sealing member that does not need to be reinflated before use. Furthermore, compared to conventional sealing members that are not expandable, this embodiment of the present invention reduces the risk of leakage due to the sealing member expanding when pressure is applied by a clinician.

[0038] Therefore, the patient contact surface of the sealing member can be formed in a predetermined anatomical shape. The patient contact surface of the sealing member can have a closed-loop shape.

[0039] When the sealing member is for a respiratory mask, the patient contact surface can generally coincide with the patient's forehead during use, but may include convex surfaces in the cheek region and / or concave surfaces in the nasal and / or chin region of the patient contact surface in the circumferential direction. The patient contact surface may include convex surfaces in the lateral or radial direction. The circumferential convex surface of the patient contact surface may extend along most 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. The convex and / or concave curvature can cause a change in the position of the patient relative to the sagittal axis of the patient contact surface during use.

[0040] When the sealing member is for a laryngeal arm squareway or endotracheal tube, the sealing member may have a shape that provides an anatomical fit with the patient's larynx or trachea.

[0041] An opening can be provided in the enclosure wall of the sealing member. The opening can allow fluid communication with the internal chamber of the sealing member. If multiple internal chambers are provided, an opening can be provided in the enclosure wall of the sealing member of each internal chamber.

[0042] In a respiratory mask, the opening in the sealing member can provide fluid communication between the internal chamber of the sealing member and the ambient air. In this embodiment, if the seal needs to be improved, the user can, during use, bias the sealing member toward the patient's face by, for example, applying pressure to the respiratory device interface toward the patient's face. The sealing member and the internal chamber are compressed, and air is released from the internal chamber, but the elasticity of the sealing member is sufficient to the extent that the internal chamber does not collapse completely, i.e., a gap remains between the opposing internal surfaces of the enclosure wall, and returns to its original shape when the pressure is removed.

[0043] The opening may always be open, or it may be opened by the airflow entering and leaving the internal chamber of the sealing member. The opening may not have a valve with a closing configuration. In some embodiments, the opening may include a valve that regulates the airflow of ambient air entering and leaving the internal chamber of the sealing member.

[0044] In invasive respiratory interface devices such as laryngeal arma squareways, the opening in the sealing member can provide fluid communication between the internal chamber of the sealing member and the gas source for inflating the sealing member, and thus can form part of a supply conduit or a connector for a supply conduit.

[0045] The sealing member may have a loop shape. The internal chamber of the sealing member may be continuous and extend around at least a large portion of the loop. The internal chamber may have a longitudinal central axis along a curved path. The curved path may extend around at least a large portion of the loop.

[0046] The loop can be circular, elliptical, triangular, or oval in shape. For example, the sealing member can be a sealing membrane for a respiratory interface device, with its outer surface being the patient contact surface. An opening can be formed in the patient contact surface to accommodate the nasal and / or oral regions of the patient's face. The patient contact surface and / or its opening can be made approximately triangular in shape, i.e., to conform to the shape of the nose and mouth of the patient's face.

[0047] The internal chamber can extend around at least 80% or at least 90% of the loop's length. The internal chamber can extend around 80–100%, 80–90%, or 90–100% of the loop's length. The loop length can refer to the length of the loop's central axis. The loop can extend over a 360-degree angle, and the internal chamber can extend around the loop over an angle of 300–360 degrees, 300–330 degrees, or 330–360 degrees. In some examples, the internal chamber can extend around the entire loop, i.e., the internal chamber can even form a loop.

[0048] The cross-sectional area of ​​the internal chamber can change, for example, due to variations in the position and / or thickness of the enclosure wall.

[0049] 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 may be separated by one or more solid portions of the sealing member. The internal chamber may include tapered ends adjacent to the solid portions of the sealing member.

[0050] A further aspect of the present invention provides a sealing member for a respiratory interface device, the sealing member comprising an internal chamber at least partially enclosed by an elastically deformable enclosure wall, the enclosure wall comprising 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.

[0051] One or more solid portions of the sealing member separating the first end and the second end of the internal chamber can be made into a single continuous solid portion.

[0052] One or more solid sections can provide greater deformation resistance in one or more selected areas of a sealing member. For example, one or more solid sections can provide greater deformation resistance in one or more selected areas of a respiratory mask sealing member, such as the jaw area, thereby eliminating the need to form additional reinforcement. Similarly, one or more solid sections can provide greater deformation resistance in the tip area of ​​the sealing cuff of a laryngeal mask squareway, thereby reducing the risk of the sealing cuff breaking during insertion into the patient's airway and eliminating the need to form additional reinforcement.

[0053] Furthermore, compared to conventional methods for manufacturing inflatable sealing members, such as blow molding, the method for manufacturing sealing members for respiratory interface devices according to the present invention reduces assembly steps, shortens manufacturing time, and lowers manufacturing costs, enabling the production of respiratory interface devices. In particular, it was found that the method for manufacturing sealing members for respiratory interface devices according to the present invention can be incorporated into manufacturing processes that fix the sealing member to the main body of the respiratory interface device in the sealing member formation step, such as two-shot molding or overmolding processes. This was previously impossible when manufacturing respiratory interface devices having inflatable sealing members.

[0054] According to a further aspect of the present invention, a sealing member for a respiratory interface device is provided, the sealing member comprising an internal chamber at least partially enclosed by an elastically deformable enclosure wall, the enclosure wall comprising a patient contact surface, the patient contact surface having a shape that provides an anatomical fit with the patient.

[0055] A further aspect of the present invention provides a method for manufacturing a respiratory interface device, including a method for manufacturing a sealing member of the respiratory interface device as defined above.

[0056] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing one or more molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, (b) Injecting the first polymer into the first cavity of the mold via the first polymer injection port to form the main body of the breathing interface device, (c) A step of forming a sealing member of the respiratory interface device, wherein the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape determined by the second cavity of the one or more molds and providing an anatomical fit with the patient, Includes, The main body and sealing member of the respiratory interface device can be formed in any order, so that one of the main body or the sealing member is formed first, and the other of the main body and the sealing member is formed later, and when the later formed portion is injection molded, the later formed portion is engaged with the earlier formed portion in a manner that fixes the main body and the sealing member of the respiratory interface device together.

[0057] The method for manufacturing a respiratory interface device according to the present invention is advantageous because it enables fewer assembly steps, shorter manufacturing time, and lower manufacturing costs compared to conventional methods for forming a respiratory interface device having an inflatable portion.

[0058] A method for manufacturing a respiratory interface device may include any of the methods for manufacturing a sealing member of a respiratory interface device as defined above, or any combination thereof.

[0059] The main body of a respiratory interface device formed by the method according to the present invention may include a flow path for the respiratory interface device. The main body of the respiratory interface device may also include a connector for connecting the device's flow path to a respiratory device such as a breathing tube and / or a source of breathing gas.

[0060] The main body of a respiratory interface device is generally formed first, while the sealing member of the respiratory interface device is generally formed later. However, in some embodiments, there may be advantages to having the sealing member of the respiratory interface device formed first and the main body of the respiratory interface device formed later.

[0061] One or more molds having a first cavity, a second cavity, and a gas introduction port opening to the second cavity can be configured such that the portion formed at the front of the respiratory interface device can be positioned adjacent to or within the cavity (either the first cavity or the second cavity) that forms the portion formed after the respiratory interface device, thereby allowing the portion formed after to engage with the portion formed before in a manner that fixes the main body and sealing member of the respiratory interface device together during injection molding of the portion formed after. During injection molding of the portion formed after, the portion formed after can be brought into contact with the portion formed before.

[0062] The main body and the sealing member can be fixed together by one or more chemical and mechanical bonds. The bond can be formed immediately after injection molding of the portion formed after the respiratory interface device, thereby eliminating the need for further assembly steps to fix the main body and the sealing member together.

[0063] The second polymer can come into contact with the boundary region of the main body of a respiratory interface device, such as a mask body or an airway tube, and this may include the periphery. If the second polymer comes into contact with a single boundary region of the main body of the respiratory interface device, the internal chamber can be surrounded only by the enclosure wall defined by the second polymer.

[0064] The gas introduction port can protrude from the inner circumferential surface of the mold defining either the first cavity or the second cavity, thereby allowing the opening to be formed in either the main body of the respiratory interface device and / or the enclosure wall of the sealing member of the respiratory interface device.

[0065] The gas introduction port of the mold can protrude into the second cavity relative to the inner circumferential surface of the mold that defines the second cavity.

[0066] In this embodiment, the portion to be formed first can be formed in the first or second cavity of the mold in the first shot configuration, and then the mold can be moved to the second shot configuration such that the portion to be formed first of the breathing interface device is positioned adjacent to the other of the first or second cavity that forms the portion to be formed later of the breathing interface device, and the portion to be formed later is engaged with the portion to be formed first in such a manner that the main body and sealing member of the breathing interface device are fixed together during injection molding of the portion to be formed later. For example, in the second shot configuration of the mold, the surface of the main body of the breathing interface device, such as the periphery of the main body or the boundary region of the surface of the main body adjacent to the periphery, can be exposed inside the cavity that forms the portion to be formed later of the breathing interface device. The first cavity can be defined by the mold in the first shot configuration, and the second cavity can be defined by the mold in the second shot configuration, but it should be noted that the first and second cavities are not necessarily defined simultaneously by the mold. Therefore, this mold can be installed in a single injection molding machine, and this process is commonly referred to as two-shot molding.

[0067] 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 forming the tip portion of the respiratory interface device in the first or second mold, the first or second mold can be opened and the tip portion can be moved to the other of the first and second molds so that it is positioned in the cavity forming the later portion of the respiratory interface device, and the later portion is engaged with the tip portion in such a manner that the main body and sealing member of the respiratory interface device are fixed together during injection molding of the later portion. Thus, the first and second molds can be provided in two separate injection molding machines, and this process is generally called overmolding.

[0068] Therefore, the manufacturing method of the respiratory interface device may be either a two-shot molding process or an overmolding process, and in both of these processes, the main body of the respiratory interface device is generally formed first, while the sealing member of the respiratory interface device is generally formed later. These two embodiments are defined separately below.

[0069] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing a mold having a first shot configuration defining a first cavity and a first polymer injection port, and a second shot configuration defining a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, (b) The step of arranging the mold in a first shot configuration, (c) The step of injecting a first polymer into a first cavity of a mold through a first polymer injection port to form the main body of a respiratory interface device, (d) The step of arranging the mold in a second shot configuration such that the main body of the respiratory interface device is positioned adjacent to the second cavity, (e) A step of forming a sealing member of a respiratory interface device by injecting a second polymer into a second cavity of a mold via a second polymer injection port and introducing gas into one or more second cavities of a mold via a gas introduction port, wherein, during injection molding of the sealing portion, the sealing member is engaged with the main body of the respiratory interface device in such a manner that the main body and the sealing member are fixed together, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape determined by the second cavity of the mold and providing an anatomical fit with the patient, Includes.

[0070] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing 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 a gas introduction port opening into the second cavity, (b) The step of injecting a first polymer into a first cavity of a first mold via a first polymer injection port to form the main body of a respiratory interface device, (c) The step of transferring the main body of the respiratory interface device to a second mold such that the main body of the respiratory interface device is positioned inside or adjacent to the second cavity, (d) A step of forming a sealing member of a respiratory interface device by injecting a second polymer into a second cavity of a second mold via a second polymer injection port and introducing gas into the second cavity of the second mold via a gas introduction port, wherein, during injection molding of the sealing portion, the sealing member is engaged with the main body of the respiratory interface device in such a manner that the main body and the sealing member are fixed together, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape that provides an anatomical fit with the patient, determined by the second cavities of one or more molds, Includes.

[0071] The gas introduction port of the mold can protrude into the second cavity. The gas introduction port can protrude relative to the inner circumferential surface of the mold defining the second cavity. Alternatively, the gas introduction port can protrude into the second cavity through the body of the breathing mask. In a two-shot molding process, the gas introduction port can protrude relative to the circumferential inner surface of the mold defining the first cavity in the first shot configuration of the mold, thereby penetrating the first polymer in the first cavity when the first polymer is injected into the first cavity of the mold to form the body of the breathing interface device, and the gas introduction port can protrude into the second cavity by penetrating the body of the breathing mask in the second shot configuration of the mold.

[0072] The gas introduction port may have an outlet opening to a second cavity through which the gas enters the second cavity. The outlet opening of the gas introduction port can be aligned with the longitudinal axis of the second cavity, and therefore with the longitudinal axis of the respiratory interface device. When the respiratory interface device is fitted to a patient, the longitudinal axis of the respiratory interface device can be aligned with the longitudinal axis of the patient. In the case of a respiratory mask, the gas introduction port can be positioned at the end of the second cavity corresponding to the apex of the nasal portion of the respiratory mask.

[0073] During manufacturing, an opening to the internal chamber can be formed around the gas introduction port, allowing ambient air to enter and exit the internal chamber during use. The opening can be formed in an elastically deformable enclosure wall formed of a second polymer. Alternatively, the internal chamber may be at least partially surrounded by a wall having a first layer defined by the first polymer and a second layer defined by the second polymer, and the opening to the internal chamber may be formed in this wall.

[0074] The gas introduction port can project outward from the inner surface of the mold defining either the first or second cavity, thereby forming an opening in either the main body of the respiratory device or / or the enclosure wall of the sealing member of the respiratory interface device. The opening can be in fluid communication with the internal chamber of the sealing member of the respiratory interface device.

[0075] Therefore, in a respiratory mask, an opening can be formed in the mask body and / or sealing member, and the opening can provide fluid communication between the internal chamber of the sealing member and the ambient air. In invasive respiratory interface devices such as laryngeal mask squareway, the opening can provide fluid communication between the internal chamber of the sealing member and the gas source that inflates the sealing member.

[0076] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing one or more molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, (b) Injecting the first polymer into the first cavity of the mold via the first polymer injection port to form the main body of the breathing interface device, (c) A step of forming a sealing member of the respiratory interface device, wherein the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface, Includes, The main body and sealing member of the respiratory interface device can be formed in any order, thereby allowing one of the main body or the sealing member to be formed first, and the other of the main body and the sealing member to be formed later, and during injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that fixes the main body and the sealing member of the respiratory interface device together. The gas introduction port protrudes from the inner circumferential surface of the mold defining the first cavity or the second cavity, thereby forming an opening in the enclosure wall of the main body of the breathing device and / or the sealing member of the breathing interface device, and the opening is in fluid communication with the internal chamber of the sealing member of the breathing interface device.

[0077] The method according to the present invention may use one or more mold tools to define one or more molds having a first cavity and a second cavity, each cavity being defined by the inner wall of the mold.

[0078] The gas introduction port of the mold can protrude into the second cavity. The gas introduction port can protrude relative to the inner circumferential surface of the mold that defines the second cavity. Alternatively, the gas introduction port can penetrate the body of the breathing mask and protrude into the second cavity.

[0079] The respiratory interface device may be manufactured using either a two-shot molding process or an overmolding process. In both of these processes, the main body of the respiratory interface device is generally formed first, while the sealing member of the respiratory interface device is generally formed later. These two embodiments are defined separately below.

[0080] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing a mold having a first shot configuration defining a first cavity and a first polymer injection port, and a second shot configuration defining a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, (b) The step of arranging the mold in a first shot configuration, (c) The step of injecting a first polymer into a first cavity of a mold through a first polymer injection port to form the main body of a respiratory interface device, (d) The step of arranging the mold in a second shot configuration such that the main body of the respiratory interface device is positioned adjacent to the second cavity, (e) A step of forming a sealing member of a respiratory interface device by injecting a second polymer into a second cavity of a mold via a second polymer injection port and introducing gas into one or more second cavities of a mold via a gas introduction port, wherein, during injection molding of the sealing portion, the sealing member is engaged with the main body of the respiratory interface device in such a manner that the main body and the sealing member are fixed together, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape determined by the second cavity of the mold and providing an anatomical fit with the patient, Includes, The gas introduction port protrudes from the inner circumferential surface of the mold defining the first cavity or the second cavity, thereby forming an opening in the enclosure wall of the main body of the breathing device and / or the sealing member of the breathing interface device, and the opening is in fluid communication with the internal chamber of the sealing member of the breathing interface device.

[0081] The gas introduction port can project outwards from the inner circumferential surface of the mold defining the second cavity. Alternatively, the gas introduction port can project outwards from the circumferential inner surface of the mold defining the first cavity in the first shot configuration of the mold, so that when the first polymer is injected into the first cavity of the mold to form the body of the respiratory interface device, the gas introduction port can penetrate the first polymer in the first cavity, and the gas introduction port can penetrate the body of the respiratory mask and project into the second cavity in the second shot configuration of the mold.

[0082] A further aspect of the present invention provides a method for manufacturing a respiratory interface device. This method is (a) Providing 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 a gas introduction port opening into the second cavity, (b) The step of injecting a first polymer into a first cavity of a first mold via a first polymer injection port to form the main body of a respiratory interface device, (c) The step of transferring the main body of the respiratory interface device to a second mold such that the main body of the respiratory interface device is positioned inside or adjacent to the second cavity, (d) A step of forming a sealing member of a respiratory interface device by injecting a second polymer into a second cavity of a second mold via a second polymer injection port and introducing gas into the second cavity of the second mold via a gas introduction port, wherein, during injection molding of the sealing portion, the sealing member is engaged with the main body of the respiratory interface device in such a manner that the main body and the sealing member are fixed together, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape that provides an anatomical fit with the patient, determined by the second cavities of one or more molds, Includes, The gas introduction port of the mold can protrude into the second cavity relative to the inner circumferential surface of the mold defining the second cavity, thereby forming an opening in the enclosure wall of the sealing member of the breathing interface device, and the opening is in fluid communication with the internal chamber of the sealing member of the breathing interface device.

[0083] In some embodiments, the gas introduction port may penetrate the body of the breathing mask and protrude into the second cavity, for example, through an opening formed during injection molding in the first mold.

[0084] Each cavity may have a single polymer injection port with an outlet opening into the cavity, through which the polymer can enter the cavity. The outlet opening of the polymer injection port can be aligned with the longitudinal axis of the second cavity, and therefore with the longitudinal axis of the respiratory interface device. When the respiratory interface device is fitted to a patient, the longitudinal axis of the respiratory interface device can be aligned with the longitudinal axis of the patient. In the case of a respiratory mask, the polymer injection port can be located at the end of the second cavity corresponding to the apex of the nasal portion of the respiratory mask. The outlet opening may be formed in the wall of the mold and may be coplanar with the inner circumferential surface of the mold defining the cavity.

[0085] Each of the first and second polymers can be injected into the corresponding cavity in the form of a polymer melt, which is a polymer liquid above its glass temperature and / or crystallization temperature. However, the injection molding process differs depending on whether the polymer is a thermoplastic or a thermosetting resin. Furthermore, in liquid injection molding, the polymer can be a liquid mixture rather than a polymer melt, which is cured in the mold, for example, by applying heat.

[0086] The first polymer can be supplied to the first injection unit. The first polymer can be heated in the injection unit until it becomes soft enough to flow, thereby forming a first polymer molten mass, and the first injection unit can be moved to engage with the injection port of the first cavity of the mold, thereby establishing fluid communication with it.

[0087] The second polymer can be supplied to the second injection unit. The second polymer can be heated in the injection unit until it becomes soft enough to flow, thereby forming a second polymer molten mass. The second injection unit can then be moved to engage with the injection port of the second cavity of the mold, thereby establishing fluid communication with it.

[0088] The first polymer is injected into the first cavity of the mold to form the main body of a respiratory interface device, such as the mask body of a respiratory mask, or the airway tube of a laryngeal mask squareway or endotracheal tube. The first polymer can be polypropylene, poly(styrene-butadiene-styrene) (SBS), polycarbonate, or other suitable material. The first polymer and the second polymer may be different.

[0089] The second polymer is injected into the second cavity of the mold to form a sealing member for the breathing interface device. The second polymer may have a lower modulus of elasticity than the corresponding modulus of the first polymer. The second polymer may be a thermoplastic elastomer such as liquid silicone rubber or a thermosetting elastomer.

[0090] When a two-shot molding process is used, the polymer for the later-formed portion can be injected into the mold cavity after the injection of the polymer for the earlier-formed portion is complete, but before the polymer for the earlier-formed portion has completely solidified. When an overmolding process is used, the earlier-formed portion of the respiratory interface device can be solidified almost or completely before being transferred to the cavity that will form the later-formed portion of the respiratory interface device.

[0091] If the polymer is a thermoplastic resin, the polymer molten is heated to a temperature higher than the ambient temperature before injection so that it can flow, and is maintained at a temperature higher than the ambient temperature during the injection step. The polymer molten solidifies once it has cooled sufficiently. Ambient temperature refers to typical room temperature, for example, 15-25°C.

[0092] If the polymer is thermosetting, it can be heated in the injection unit to a temperature that is soft enough to flow but does not begin to harden. Alternatively, in liquid injection molding, the polymer can be a liquid mixture rather than a polymer molten, which is hardened in the mold, for example, by applying heat. The polymer can then be injected into the mold cavity. Gas injection and sealing member formation are the same as in the case of thermoplastic resins. However, the polymer is not cooled to solidify. Instead, the mold is heated to a temperature of, for example, 180-200°C to initiate hardening.

[0093] A further aspect of the present invention provides a respiratory interface device manufactured by the method defined above.

[0094] For example, a sealing member of a respiratory interface device can be fixed to the main body of the respiratory interface device by a chemical or mechanical bond provided by either two-shot molding or overmolding. The bond between the main body and the sealing member can be made permanent.

[0095] The patient contact surface of the sealing member may have a closed-loop shape. When the sealing member is for a respiratory mask, the patient contact surface may generally coincide with the patient's forehead during use, but may include a convex surface in the cheek region and / or a concave surface in the nasal and / or chin region of the patient contact surface in the circumferential direction. The patient contact surface may include convex surfaces in the lateral or radial direction. The circumferential convex surface of the patient contact surface may extend along most of the length of the mask. The convex and / or concave curvature may cause a change in the position of the patient relative to the sagittal axis of the patient contact surface during use.

[0096] The main body of the respiratory interface device may include, for example, the mask body of a respiratory mask or a flow path defined by an endotracheal tube or the airway tube of a laryngeal mask squareway. The sealing member may be for sealing against a surface of the patient's body, which may be an outer or inner surface, to form an effective seal with the patient's airway.

[0097] A respiratory interface device can be a non-invasive interface device in which a sealing member seals the flow path, for example, the mask body, against the patient's face, thereby forming an effective fluid connection between the flow path and the patient's mouth and / or nose. Alternatively, a respiratory interface device can be an invasive interface device in which a sealing member seals the flow path against the inner surface of the patient's airway, thereby forming an effective fluid connection between the device's flow path, for example, the airway tube, and the patient's airway.

[0098] The sealing member and / or patient contact surface can be configured as a continuous loop, which can extend around the inlet of the flow path of the respiratory interface device.

[0099] The respiratory interface device can be a mask, where the main body of the respiratory interface device defines a mask body that accommodates the nose, or mouth and nose, and the sealing member is for engaging with the patient's face and may take the form of a sealing cushion. The main body of the respiratory interface device may also include a connector for connecting the mask body of the device to a respiratory device such as a breathing tube and / or a source of respiratory gas. The connector can be located at one end of the flow path defined by the mask body relative to the end where the sealing member is located.

[0100] The respiratory interface device can be an endotracheal tube or a supraglottic airway such as a laryngeal arm squareway, where the main body of the respiratory interface device defines the airway tube, and the sealing member engages with the patient's larynx or trachea and may have the form of a sealing cuff. The main body of the respiratory interface device may also include a connector for connecting the device's airway tube to a respiratory device such as a breathing tube and / or a source of breathing gas. The connector can be located at one end of the flow path defined by the airway tube relative to the end where the sealing member is located.

[0101] 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 may be separated by one or more solid portions of the sealing member. The internal chamber may include tapered ends adjacent to the solid portions of the sealing member.

[0102] A further aspect of the present invention provides a respiratory interface device comprising a main body of a respiratory interface device formed from a first polymer and a sealing member of a respiratory interface device formed from a second polymer, wherein the sealing member of the respiratory interface device is fixed to the main body of the respiratory interface device, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall 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.

[0103] For example, a sealing member of a respiratory interface device can be fixed to the main body of the respiratory interface device by a chemical or mechanical bond provided by either two-shot molding or overmolding. The bond between the main body and the sealing member can be made permanent.

[0104] The solid portion of the sealing member or each solid portion can be a single continuous solid body of the second polymer. One or more solid portions of the sealing member separating the first end and the second end of the internal chamber can be a single continuous solid body of the second polymer.

[0105] One or more solid sections can provide greater deformation resistance in one or more selected areas of a respiratory interface device. For example, one or more solid sections can provide greater deformation resistance in one or more selected areas of a respiratory mask sealing member, such as the jaw area, thereby eliminating the need to form additional reinforcement. Similarly, one or more solid sections can provide greater deformation resistance in the tip area of ​​the sealing cuff of a laryngeal arma squareway, thereby reducing the risk of the sealing cuff breaking during insertion into the patient's airway and eliminating the need to form additional reinforcement.

[0106] The respiratory interface device may include an opening in the enclosure wall of the sealing member and / or in the wall of the main body of the respiratory interface device, such as the mask body, so that the opening is in fluid communication with the internal chamber of the sealing member of the respiratory interface device, allowing ambient air to enter and exit the internal chamber during use. This feature can improve the compliance (elasticity) of the sealing member when biased against the patient's surface during use, and therefore improve the seal achieved with that surface.

[0107] According to a further aspect of the present invention, a respiratory interface device comprising a main body of a respiratory interface device formed from a first polymer and a sealing member of a respiratory interface device formed from a second polymer, wherein the sealing member of the respiratory interface device is fixed to the main body of the respiratory interface device, the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall includes a patient contact surface, and the respiratory interface device includes an opening in the enclosure wall of the sealing member and / or in the wall of the main body of the respiratory interface device, thereby enabling fluid communication between the opening and the internal chamber of the sealing member of the respiratory interface device, allowing ambient air to enter and exit the internal chamber during use.

[0108] A respiratory interface device according to this aspect of the present invention comprises an elastically deformable enclosure wall including a patient contact surface that provides an anatomical fit with the patient, an internal chamber at least partially enclosed by the elastically deformable enclosure wall, and an opening that allows ambient air to enter and exit the internal chamber during use. This combination of features provides an effective seal between the sealing member and the patient due to its anatomical fit, but if the seal needs to be improved, the internal chamber and the opening that allows ambient air to enter and exit the internal chamber during use can also bias the sealing member towards the patient, for example, the patient's face. In particular, the internal chamber and the opening that allows ambient air to enter and exit the internal chamber during use can give the sealing member greater deformability relative to a given thickness of the elastically deformable enclosure wall compared to conventional inflatable sealing members. This allows for a thicker wall thickness than conventional inflatable sealing members that do not release gas from the internal chamber during use, and this thicker wall thickness can provide advantages including better maintenance of the anatomical shape during and after deformation, improved durability and reduced risk of damage, and a sealing member that does not need to be reinflated before use. Furthermore, compared to conventional sealing members that are not expandable, this embodiment of the present invention reduces the risk of leakage due to the sealing member expanding when pressure is applied by a clinician.

[0109] The breathing interface device can be a breathing mask. The opening may always be open or may be opened by the airflow entering and leaving the internal chamber of the sealing member. The opening may not have a valve with a closing configuration. In some embodiments, the opening may include a valve that regulates the airflow of ambient air entering and leaving the internal chamber of the sealing member. The valve may be a two-way valve. If the opening is formed in the wall of the mask body of the breathing interface device and in any wall of the sealing member below it, the risk of the opening becoming blocked during use can be reduced.

[0110] In this configuration, the gas pressure inside the internal chamber can be set to atmospheric pressure, but the enclosure walls can nevertheless have sufficient rigidity to maintain their shape during handling, unless, for example, they are subjected to sufficient pressure against the patient's face during use.

[0111] When a user applies pressure to the respiratory device interface toward the patient's surface, for example, the sealing member is biased toward the patient's surface, the sealing member and the internal chamber are compressed, causing air to escape from the internal chamber. However, the rigidity of the sealing member is sufficient if, upon compression, the internal chamber does not collapse completely, that is, a gap remains between the opposing internal surfaces of the enclosure walls, and the enclosure walls and internal chamber return to their original shape when the pressure is removed.

[0112] A further aspect of the present invention provides a respiratory interface device comprising a main body of a respiratory interface device formed from a first polymer and a sealing member of a respiratory interface device formed from a second polymer, wherein the sealing member of the respiratory interface device is fixed to the main body of the respiratory interface device, and the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall including a patient contact surface, and the patient contact surface providing an anatomical fit with the patient.

[0113] A further aspect of the present invention provides a breathing circuit comprising a breathing gas source, a patient interface device as defined above, and a breathing tube extending between the breathing gas source and the patient interface device.

[0114] With reference to the attached drawings, implementable embodiments of the present invention will be described as merely examples. [Brief explanation of the drawing]

[0115] [Figure 1]This is a rear view of the mask body formed in the first shot of the two-shot molding method according to the first embodiment of the present invention. [Figure 2] This is a schematic diagram of the first stage of the second shot in the two-shot molding method according to the first embodiment of the present invention, in which the polymer molten material of the second shot is introduced. [Figure 3] This is a schematic diagram of the second stage of the second shot in the two-shot molding method according to the first embodiment of the present invention, where the polymer molten material of the second shot has been completely introduced. [Figure 4] This is a schematic diagram of the third stage of the second shot in a two-shot molding method according to the first embodiment of the present invention, in which gas is partially introduced into the polymer molten material of the second shot. [Figure 5] This is a schematic diagram of the fourth stage of the second shot in the two-shot molding method according to the first embodiment of the present invention, where the gas has been completely introduced into the polymer molten material of the second shot. [Figure 6] This is a breathing mask formed by a two-shot molding method according to the first embodiment of the present invention, and shows polymer and gas inlets for a second shot. [Figure 7] This is a first perspective view of a breathing mask formed by a two-shot molding method according to a second embodiment of the present invention. [Figure 8] This is a second perspective view of a breathing mask formed by a two-shot molding method according to a second embodiment of the present invention. [Modes for carrying out the invention]

[0116] The method according to the first embodiment of the present invention, shown in Figures 1 to 6, is a two-shot injection molding method for manufacturing a breathing mask.

[0117] An injection molding process typically involves an apparatus comprising an injection unit which includes an exit nozzle, a tool for defining the mold, and a clamping unit. The clamping unit is positioned to move the mold components between a closed configuration that allows the polymer molten material to be injected into the mold cavity and an open configuration that allows the molded part to be removed from the mold.

[0118] The mold tool defines a mold having a first cavity and a second cavity, each cavity having a polymer injection port for introducing a polymer molten material into the cavity, and each cavity is defined by the inner wall of the mold.

[0119] In this embodiment, the first injection unit for the first shot of the two-shot injection molding method is provided with a first polymer molten material, which is polypropylene (PP), a thermoplastic resin. The first polymer molten material is heated in the injection unit until it is soft enough to flow, and the outlet nozzle of the injection unit is moved to engage with the injection port of the first cavity of the mold, thereby establishing fluid communication.

[0120] Furthermore, the second injection unit for the second shot of the two-shot injection molding method is provided with a second polymer molten material, which in this embodiment is a thermoplastic elastomer (TPE) of a thermoplastic resin. The second polymer molten material 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 with the injection port of the second cavity of the mold, thereby establishing fluid communication.

[0121] In the first shot of the method according to the first embodiment of the present invention, the mold is moved to its first shot configuration. Next, the first injection unit applies pressure to the first polymer molten material using, for example, a piston and cylinder configuration (also known in the art as a screw and barrel configuration) and injects (injects) the first polymer molten material into the first cavity of the mold through an outlet nozzle and a polymer injection port. Then, while maintaining the pressure applied to the polymer molten material, the polymer molten material in the first cavity is cooled, and the polymer molten material is partially solidified.

[0122] The polymer molten material injected into the first cavity takes the shape of the mask body 10. This mask body is shown in Figure 1, and the mold is not shown for clarity.

[0123] The mask body 10 comprises a periphery 16 and a tapered wall 12 extending forward and inward from the periphery 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 generally dome-shaped and comprises a mouth portion having a substantially annular cross-section on the surface of the patient's face, i.e., the frontal surface, when in use, and a narrowed nose portion that is substantially triangular in shape and has a rounded apex for engaging with the bridge of the patient's nose. In the mask body shown in Figure 1, the nose portion of the tapered wall 12 also includes a narrowed portion along the longitudinal axis of the mask body, which extends from the tubular connector 14 toward the rounded apex of the nose portion of the tapered wall 12. This narrowed portion of the tapered wall 12 defines a side that can be grasped by the user, for example, by a pinching motion.

[0124] In the two-shot injection molding method, once the mask body 10 is formed in a partially solidified state in the first shot, the mold is then moved to enter the second shot configuration, thereby establishing fluid communication between the second cavity of the mold and the peripheral edge 16 of the mask body 10 and the boundary region of the surface of the mask body 10 adjacent to the peripheral edge 16.

[0125] In the second shot of the method according to the first embodiment of the present invention, while the mask body 10 is partially solidified, the second injection unit applies pressure to the polymer molten material, for example using a piston and cylinder configuration, and injects the second polymer molten material into the second cavity of the mold through an outlet nozzle and a polymer injection port. A foaming agent may be mixed with the second polymer molten material of the second injection unit before applying pressure and injecting it into the second cavity of the mold, thereby ensuring that the gas injected through the mold cavity is more uniform. This method is further described in UK Patent Application No. 2013108.2.

[0126] Figure 2 shows the second polymer melt 20 partially introduced into the second cavity, and Figure 3 shows the second polymer melt 20 fully introduced into the second cavity. The second polymer melt 20 only partially fills the second cavity as shown in Figure 3, and therefore the volume of the second polymer melt 20 is smaller than the volume of the second cavity. 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), and the second cavity extends in both directions from the polymer injection port 28 around the periphery 16 of the mask body 10, so the second polymer melt 20 flows from the polymer injection port 28 along the second cavity in two branches 21, 22, extending approximately the same distance to the second cavity in each branch 21, 22.

[0127] Once the second polymer molten material 20 has been fully introduced into the second cavity and partially filled the second cavity, nitrogen gas 30 is introduced into the second polymer molten material 20 in the second cavity through a gas introduction port 38 (see Figure 6). The gas introduction port 38 is located adjacent to and perpendicular to the polymer injection port 28 for the second cavity. The gas introduction port 38 extends from the wall of the second cavity into the central region of the second cavity so that the gas forms bubbles within the second polymer molten material 20 in the second cavity.

[0128] Furthermore, the gas introduction port 38 is located at the apex of the nose portion of the mask body 10, and the second cavity extends in both directions from the gas introduction port 38 around the periphery 16 of the mask body 10. As a result, the bubbles of gas 30 flow from the gas introduction port 38 into the second cavities of the two branches 31 and 32 along the central axis of the second polymer molten body 20.

[0129] Figure 4 shows the gas 30 partially introduced into the second polymer molten material 20 of the second cavity, and Figure 5 shows the gas fully introduced into the second polymer molten material 20 of the second cavity.

[0130] As shown in Figures 4 and 5, the introduction of gas 30 causes the second polymer molten material 20 to move further along the second cavity toward the jaw region of the mask body 10 until the two branches 21 and 22 of the second polymer molten material 20 merge, mix, and bond in the jaw region of the mask body 10. In this embodiment, the gas 30 introduced into the second polymer molten material 20 in the second cavity is sufficient to form a thin sealing cushion 42 from the second polymer molten material 20, which has a gas-filled internal chamber 44. However, the gas 30 introduced into the second polymer molten material 20 in the second cavity remains within the two branches 31 and 32 and does not merge in the jaw region of the mask body 10. Instead, the two branches 31 and 32 of the gas-filled internal chamber 44 each terminate at tapered ends, each tapered end positioned on each side of the solid portion of the second polymer molten material, i.e., the portion of the second polymer molten material that does not contain the gas-filled interior, and these portions form the jaw region 46 of the sealing cushion 42.

[0131] Once the sealing cushion 42 of the breathing mask is formed, the pressure applied to the polymer molten material by the gas 30 is maintained while the mask body 10 and the sealing cushion 42 are cooled and completely solidified. This causes the second polymer to bond to the boundary region and periphery of the mask body 10, and the mask body 10 and the sealing cushion 42 of the breathing mask are joined together. Therefore, no additional assembly steps, such as adhesive bonding, are required to fix the mask body 10 and the sealing cushion 42 to each other.

[0132] The second cavity of the mold is shaped to bring an anatomical shape to the sealing cushion 42 of the breathing mask that is configured to correspond to the contours of the patient's face around the nose and mouth.

[0133] The sealing cushion 42 of the breathing mask includes a thin enclosure wall surrounding the gas-filled internal chamber 44. Furthermore, since the gas introduction port 38 extends from the wall of the second cavity to the central region of the second cavity, the wall of the breathing mask sealing cushion 42 is formed around the gas introduction port 38, thereby creating an opening in the wall of the breathing mask sealing cushion 42 when the breathing mask is removed from the mold. This opening in the wall of the breathing mask sealing cushion 42 provides fluid communication between the gas-filled internal chamber 44 of the breathing mask sealing cushion 42 and the ambient air.

[0134] Figures 7 and 8 show a breathing mask 100 formed by a two-shot molding method according to a second embodiment of the present invention. This breathing mask 100 is identical to the breathing mask formed by the first embodiment of the method according to the present invention described above, except for the position of the opening 138 formed by the gas introduction port 38.

[0135] In a breathing mask 100 formed by a second embodiment of the method according to the present invention, the opening 138 formed by the gas introduction port is located on the wall of the mask body 112 and the sealing cushion 142 beneath it, rather than on the deformable wall of the sealing cushion 142 extending from the mask body 112. This position of the opening 138 is achieved in a second shot configuration of the mold by providing a mold in which the gas introduction port 38 extends from the wall of the first cavity of the mold to the central region of the second cavity of the mold. In this configuration, when the 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 gas introduction port 38. In the second shot configuration of the mold, the gas introduction port 38 penetrates the mask body 112 in the first cavity and protrudes into the second cavity. In this configuration, when the second polymer is injected into the second cavity of the mold to form the sealing cushion 142, the wall of the sealing cushion 142 beneath the adjacent wall of the mask body 112 is formed around the gas introduction port 38. Thus, when the breathing mask 100 is removed from the mold, an opening 138 is formed in the wall of the mask body 112 and the sealing cushion 142 beneath it. This opening 138 provides fluid communication between the gas-filled internal chamber of the sealing cushion 42 of the breathing mask 100 and the ambient air.

[0136] In a third embodiment of the method according to the present invention, an overmolding process is used. This differs from the first and second embodiments, which are two-shot molding processes, in that the mask body (substrate) formed of the first polymer is generally almost or completely solidified before being transferred to a second cavity in a second mold, and the second polymer is injected into the second cavity and molded, 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 chemical and mechanical bonds.

[0137] Furthermore, any of the first, second, and third embodiments can be used in conjunction with a thermosetting polymer for sealing members, for example. For instance, liquid silicone rubber (LSR) can be used as the second polymer for forming the sealing member. However, when using a thermosetting polymer, the injection molding step and associated apparatus differ from those described above, as thermosetting polymers generally require heat to begin curing. In the case of liquid silicone rubber, a liquid injection molding (LIM) process is commonly used.

[0138] The materials commonly used in the LIM process are silicone and acrylic. In the LIM process, a base-forming plastic that can be reinforced with additives and fibers and a catalyst are combined using a pump. Each is injected in a 1:1 ratio into a static mixer to form a mixture, for example, liquid silicone rubber (LSR). The outlet nozzle of the injection unit is moved to engage with the injection port in the mold cavity, establishing fluid communication with it.

[0139] Next, the liquid mixture is poured into the mold cavity. Gas injection and sealing member formation are the same as described above for thermoplastic resins. However, the polymer is not cooled to solidify. Instead, the mold is heated to a temperature of, for example, 180-200°C to initiate curing. Once the polymer has cured, the breathing interface device can be removed from the mold.

[0140] The following are additional notes to this disclosure. (Additional note 1) A method for manufacturing a sealing member for a respiratory interface device, (a) A step of providing a mold having a cavity, a polymer injection port and a gas introduction port, (b) The step of injecting the polymer into the cavity of the mold through the polymer injection port, (c) The step of introducing gas into the cavity of the mold via the gas introduction port, Includes, This forms the sealing member for the respiratory interface device, The sealing member of the respiratory interface device comprises an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, the enclosure wall comprising a patient contact surface, the patient contact surface having a shape determined by the cavity of the mold, which provides an anatomical fit with the patient. (Additional note 2) The method according to Appendix 1, wherein the patient contact surface has a leading portion which is the part that contacts the patient's surface before the sealing member deforms, and the leading portion is anatomically shaped in a direction in which the sealing member engages with the patient's surface, so that the position of the leading portion of the patient contact surface changes in this direction at different positions along the patient contact surface. (Additional note 3) The method according to Appendix 2, wherein the leading portion of the patient contact surface and / or the center line on the leading portion have a position that changes with respect to a reference plane which is a reference plane or a reference cylindrical surface, and the reference plane is positioned perpendicular to the direction in which the sealing member engages with the patient's surface, or to the direction of the overall pressure applied to the patient's surface by the sealing member. (Additional note 4) The method according to any one of Appendix 1 to 3, wherein the gas introduction port of the mold is connected to a gas source, and the gas has sufficient pressure to induce, deform, and / or move the polymer in the cavity of the mold to form the sealing member. (Additional note 5) The method according to any one of appendices 1 to 4, wherein the gas introduction port of the mold protrudes into the cavity and has an outlet opening to the cavity, the gas enters the cavity through the outlet opening, and the outlet opening is away from the inner circumferential surface of the mold defining the cavity. (Additional note 6) The method according to any one of the appendices 1 to 5, wherein the gas introduction port protrudes from the inner circumferential surface of the mold defining the cavity, thereby forming an opening in the enclosure wall of the sealing member, and the opening is in fluid communication with the internal chamber of the sealing member. (Additional note 7) The method according to any one of the appendices 1 to 6, wherein a polymer is injected into the cavity of the mold via the polymer injection port such that the cavity of the mold is only partially filled. (Additional note 8) The method according to Appendix 7, wherein, after the injection of the polymer but before the introduction of gas, the polymer injected into the cavity of the mold has a volume smaller than the volume of the cavity, so that the polymer extends only partially along the cavity in the form of a single structure separated from the end of the cavity opposite to the end of the cavity where the polymer injection port is located. (Additional note 9) The method according to any one of appendices 1 to 8, wherein, once 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 gas introduction port. (Additional note 10) The method according to any one of appendices 1 to 9, wherein the internal chamber, at least partially enclosed by an elastically deformable enclosure wall formed of the polymer, is formed within the sealing member in the cavity of the mold. (Additional note 11) The method according to any one of appendices 1 to 10, wherein during manufacturing, the polymer injection port for the cavity is located at one end of the sealing member, and the sealing member is formed by the polymer flowing in both directions from the polymer injection port along the cavity. (Additional note 12) The gas applies pressure to the polymer to form the internal chamber and the surrounding wall of the polymer. The method according to any one of the appendices 1 to 11, wherein 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, thereby forming the enclosure wall 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 gas introduction port. (Additional note 13) The method according to any one of appendices 1 to 12, wherein during manufacturing, the gas introduction port is located at one end of the sealing member, and the internal chamber is formed by the gas flowing in both directions from the gas introduction port through the polymer along the cavity. (Additional note 14) The method according to any one of appendices 1 to 13, wherein the polymer is moved along the cavity having a closed-loop shape in the direction opposite to the polymer injection port and / or the gas introduction port, so that the polymer has two branches that advance along the cavity. (Additional note 15) The method according to any one of appendices 1 to 14, wherein the sealing member has a solid portion which is a portion without an internal chamber, and the solid portion is located at the end of the cavity opposite to the gas introduction port. (Additional note 16) A sealing member for a respiratory interface device manufactured by the method described in any one of the appendices 1 to 15. (Additional note 17) The sealing member according to Appendix 16, comprising an internal chamber at least partially enclosed by an elastically deformable enclosure wall, the enclosure wall comprising a patient contact surface having a shape that provides an anatomical fit with the patient, and the sealing member comprising an opening of the sealing member that is in fluid communication with the internal chamber and ambient air, thereby allowing ambient air to enter and exit the internal chamber during use. (Additional note 18) The sealing member according to Appendix 16 or Appendix 17, wherein the sealing member is for a respiratory mask, and the patient contact surface generally coincides with the patient's forehead when in use, but the patient contact surface includes a convex surface in the cheek region and / or a concave surface in the circumferential direction in the nasal and / or chin regions of the patient contact surface. (Additional note 19) The sealing member according to Appendix 17 or Appendix 18, wherein an opening is provided in the enclosure wall of the sealing member, and the opening is in fluid communication with the internal chamber of the sealing member and the surrounding air, thereby allowing the surrounding air to enter and exit the internal chamber during use. (Additional note 20) The sealing member according to Appendix 19, wherein the opening includes a valve that regulates the flow of ambient air entering and leaving the internal chamber of the sealing member, and the valve is opened by the flow of air entering and leaving the internal chamber of the sealing member. (Additional note 21) The sealing member according to any one of the appendices 15 to 20, wherein the sealing member has one or more solid portions without an internal chamber, so that the internal chamber has a first end and a second end separated by one or more solid portions of the sealing member. (Additional note 22) The sealing member according to Appendix 21, wherein the one or more solid portions of the sealing member separating the first end and the second end of the internal chamber consist of a single continuous solid portion. (Additional note 23) The sealing member according to any one of the appendices 15 to 22, wherein the sealing member is for a breathing mask, and the one or more solid portions provide greater deformation resistance in one or more selected regions of the sealing member, including the jaw region. (Additional note 24) The sealing member according to any one of the appendices 15 to 22, wherein the sealing member is for a laryngeal squareway, and the one or more solid portions can provide greater deformation resistance in the tip region of the sealing cuff of the laryngeal squareway. (Additional note 25) A method for manufacturing a respiratory interface device, comprising a method for manufacturing a sealing member for a respiratory interface device as described in any one of the appendices 1 to 15. (Additional note 26) A method for manufacturing a respiratory interface device, (a) Providing one or more molds having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, (b) Injecting the first polymer into the first cavity of the mold via the first polymer injection port to form the main body of the breathing interface device, (c) A step of forming a sealing member of the respiratory interface device, wherein the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface having a shape determined by the second cavity of the one or more molds and providing an anatomical fit with the patient, Includes, A method wherein the main body and sealing member of the respiratory interface device can be formed in any order, thereby allowing one of the main body or the sealing member to be formed first, and the other of the main body and the sealing member to be formed later, and during injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that fixes the main body and the sealing member of the respiratory interface device together. (Additional note 27) The method according to Appendix 26, which includes a method for manufacturing a sealing member for a respiratory interface device as described in any one of Appendix 1 to 15. (Additional note 28) The method according to Appendix 26 or Appendix 27, wherein the main body of the respiratory interface device is formed first, and the sealing member of the respiratory interface device is formed later. (Additional note 29) The method according to any one of the appendices 26 to 28, wherein one or more molds are configured such that a portion formed before the respiratory interface device is adjacent to or located within a cavity of either the first cavity or the second cavity that forms a portion formed after the respiratory interface device, thereby allowing the portion formed later to engage with the portion formed earlier during injection molding of the portion formed later in such a manner that the main body and the sealing member of the respiratory interface device are fixed together. (Additional note 30) The method according to Appendix 29, wherein the later-formed portion is brought into contact with the earlier-formed portion during injection molding of the later-formed portion. (Additional note 31) The one or more molds include a mold having a first shot configuration defining a first cavity and a first polymer injection port, and a second shot configuration defining a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity, wherein in the first shot configuration, the first polymer is injected into the first cavity of the mold via the first polymer injection port to form the main body of the respiratory interface device, and in the second shot configuration, the respiratory interface The method according to any one of the appendices 26 to 30, wherein the main body of the breathing interface device is positioned adjacent to the second cavity, the second polymer is injected into the second cavity of the mold via the second polymer injection port, the gas is introduced into the second cavity of the mold via the gas introduction port to form the sealing member of the breathing interface device, and the sealing member is engaged with the main body in such a manner that the main body and the sealing member of the breathing interface device are fixed together during injection molding of the sealing portion. (Additional note 32) 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 a gas introduction port opening into the second cavity, thereby injecting the first polymer into the first cavity of the first mold via the first polymer injection port to form the main body of the respiratory interface device, and then positioning the main body of the respiratory interface device in or adjacent to the second cavity. The method according to any one of the appendices 26 to 30, comprising transferring the main body of the respiratory interface device to the second mold, injecting the second polymer into the second cavity of the second mold via the second polymer injection port, introducing the gas into the second cavity of the second mold via the gas introduction port to form the sealing member of the respiratory interface device, and engaging the sealing member with the main body of the respiratory interface device in such a manner that the main body and the sealing member are fixed together during injection molding of the sealing portion. (Additional note 33) The method according to any one of appendices 26 to 32, wherein the second polymer contacts the boundary region of the main body of the respiratory interface device. (Additional note 34) The method according to any one of the appendices 26 to 33, wherein during manufacturing, an opening to the internal chamber is formed around the gas introduction port, and the opening allows ambient air to enter and exit the internal chamber during use. (Additional note 35) The method according to appendix 34, wherein the opening is formed in the elastically deformable enclosure wall formed from the second polymer. (Additional note 36) The method according to appendix 34, wherein the internal chamber is at least partially surrounded by a wall having a first layer defined by the first polymer and a second layer defined by the second polymer, and the opening to the internal chamber is formed in the wall. (Additional note 37) The method according to any one of appendices 34 to 36, wherein the gas introduction port protrudes from the inner surface of the mold defining either the first cavity or the second cavity, thereby forming the opening in either the main body of the respiratory interface device and / or the enclosure wall of the sealing member of the respiratory interface device. (Additional note 38) The method according to any one of appendices 34 to 37, wherein the gas introduction port penetrates the main body of the breathing mask and protrudes into the second cavity. (Additional note 39) A respiratory interface device manufactured by any one of the methods described in Appendix 25 to 38. (Additional note 40) A respiratory interface device including a sealing member as described in any one of the appendices 16 to 24. (Additional note 41) A respiratory interface device as described in Appendix 40, manufactured by the method described in any one of Appendix 25 to 38. (Additional note 42) A breathing circuit comprising a source of breathing gas, a patient interface device as described in any one of appendices 39 to 41, and a breathing tube extending between the source of breathing gas and the patient interface device.

Claims

1. A respiratory interface device comprising a main body of the respiratory interface device formed from a first polymer and a sealing member of the respiratory interface device formed from a second polymer, wherein the sealing member of the respiratory interface device is fixed to the main body of the respiratory interface device, the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall includes a patient contact surface, and the respiratory interface device includes an opening in the wall of the main body of the respiratory interface device, thereby enabling fluid communication between the opening and the internal chamber of the sealing member of the respiratory interface device, allowing ambient air to enter and exit the internal chamber during use. A respiratory interface device wherein the internal chamber is at least partially surrounded by a wall having a first layer defined by the first polymer and a second layer defined by the second polymer, wherein the first layer and the second layer are bonded to each other in the wall so as to overlap, and the opening to the internal chamber is formed in the wall.

2. A respiratory interface device according to claim 1, which is a respiratory mask.

3. The respiratory interface device according to claim 1 or 2, wherein the opening is always open.

4. The respiratory interface device according to any one of claims 1 to 3, wherein the opening is not a valve having a closing configuration.

5. The respiratory interface device according to any one of claims 1 to 4, wherein the sealing member has one or more solid portions that do not have an internal chamber.

6. The breathing interface device according to claim 5, wherein the internal chamber has a first end and a second end, and the first end and the second end are separated by one or more solid portions of the sealing member.

7. The respiratory interface device according to claim 6, wherein the one or more solid portions of the sealing member separating the first end and the second end of the internal chamber are a single continuous solid body.

8. The respiratory interface device according to any one of claims 5 to 7, wherein the sealing member is for a respiratory mask, and the one or more solid portions provide greater deformation resistance in one or more selected regions of the sealing member.

9. The respiratory interface device according to claim 8, wherein the one or more solid portions provide greater deformation resistance in the jaw region of the sealing member.

10. The respiratory interface device according to any one of claims 5 to 7, wherein the sealing member is for a laryngeal arma squareway, and the one or more solid portions provide greater deformation resistance to the tip region of the sealing cuff of the laryngeal arma squareway.

11. A method for manufacturing a respiratory interface device according to any one of claims 1 to 10, (a) A device having a first cavity, a first polymer injection port, a second cavity, a second polymer injection port, and a gas introduction port opening into the second cavity The steps include providing one or more molds, (b) Injecting the first polymer into the first cavity of the mold via the first polymer injection port to form the main body of the breathing interface device, (c) A step of forming a sealing member of the respiratory interface device, wherein the sealing member of the respiratory interface device includes an internal chamber at least partially enclosed by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient contact surface, Includes, The main body and sealing member of the respiratory interface device can be formed in any order, thereby allowing one of the main body or the sealing member to be formed first, and the other of the main body and the sealing member to be formed later, and during injection molding of the later formed portion, the later formed portion is engaged with the earlier formed portion in a manner that fixes the main body and the sealing member of the respiratory interface device together. The gas introduction port protrudes from the inner circumferential surface of the mold defining the first cavity or the second cavity, thereby forming an opening in the enclosure wall of the main body and / or the sealing member of the respiratory interface device, and the opening is in fluid communication with the internal chamber of the sealing member of the respiratory interface device. The method wherein the internal chamber is at least partially surrounded by a wall having a first layer defined by the first polymer and a second layer defined by the second polymer, wherein the first layer and the second layer are bonded to each other in the wall so as to overlap, and the opening to the internal chamber is formed in the wall.

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