Improvement relating to respiratory interface device

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 related manufacturing methods. [Background technology]

[0002] To connect the respiratory apparatus to the patient's respiratory system, the respiratory apparatus typically includes some form of respiratory interface device. There are 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 such as laryngeal mask airways.

[0003] Many of these interface devices are configured to seal against a surface of the patient's body, which can be an exterior surface or an interior surface, to form an effective seal with the patient's airway. For example, non-invasive interface devices typically include a sealing member that seals the device against the patient's face and forms an effective connection between the device and the patient's mouth and / or nose, while invasive interface devices often include a sealing member that seals the device against an interior 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 cuff, which is formed by a thin enclosing wall that surrounds a gas-filled interior chamber.

[0005] An example of a respiratory interface device is an anesthesia mask. An anesthesia mask is a respiratory mask that is held over a patient's nose and mouth during the delivery of anesthesia gas to the patient. These masks generally include a mask body that includes a tubular connector that connects to a source of anesthesia gas, and an inflatable sealing cushion that extends around the periphery of an inlet to the mask body. The inflatable sealing cushion has thin walls that require sufficient pressure of gas above atmospheric pressure inside the sealing cushion to retain its shape and allow elastic deformation. The sealing cushion generally includes an inlet with a one-way valve that allows the sealing cushion to be inflated. The sealing cushion can also be deflated using a syringe. In use, a conventional anesthesia mask with an inflated sealing cushion is placed over the patient's nose and mouth and is urged against the patient's face until a sufficient seal is obtained to allow the anesthesia gas to be delivered to the patient. However, a significant amount of pressure may be required to achieve an acceptable seal.

[0006] A further significant drawback of respiratory interface devices that include an inflatable portion is the cost of manufacture, which typically requires an assembly step to attach the inflatable portion to the rest of the device, and in many devices an additional step to provide a valve to allow inflation of the inflatable portion. Specifically, blow molding is commonly used to form an inflatable sealing member that is then bonded to a body portion, such as a more rigid mask body. Blow molding uses either a pre-formed insert with a hollow interior that is expanded in a mold in a process called injection blow molding, or an extruded parison tube that is clamped at each end and expanded 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 an anatomically shaped, flexible sealing member to provide an effective seal with the patient, e.g., the patient's face. These devices can be formed in a two-shot injection molding process that reduces assembly steps compared to the manufacture of respiratory interface devices with inflatable portions. In general, these masks require less applied pressure to achieve an acceptable seal. However, these devices have the disadvantage that if an acceptable seal is not achieved, the sealing cushion or sealing cuff cannot further adapt to the patient's face when increased pressure is applied, and there is a risk that the sealing member will deform and expand when pressure is applied, resulting in leakage. Summary of the Invention [Problem to be solved by the invention]

[0008] SUMMARY OF THE DISCLOSURE An improved method of manufacturing a respiratory interface device, and an improved respiratory interface device, has now been devised that overcomes or substantially mitigates the above-referenced and / or other disadvantages associated with the prior art. [Means for solving the problem]

[0009] According to a first aspect of the present invention, there is provided a method of manufacturing a sealing member for a respiratory interface device, the method comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold through the polymer injection port; (c) introducing a gas into the cavity of the mold through the gas introduction port; Including, thereby forming a sealing member for the respiratory interface device; The sealing member of the respiratory interface device includes an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed from the polymer, the enclosure wall including a patient-contacting surface, the patient-contacting surface having a shape determined by the cavity of the mold and providing an anatomical fit with a patient.

[0010] The method according to the invention provides a sealing member for a respiratory interface device, the sealing member comprising an internal chamber at least partially surrounded by an elastically deformable enclosure wall defined by a polymer and thus capable of functioning similarly to the inflatable portion of prior art devices, and the enclosure wall including a patient contacting surface determined by a mold cavity and having a shape that provides an anatomical fit with the patient and thus configured to function similarly to the anatomically shaped sealing membranes of the prior art. This combination of features allows for the formation of a sealing member that provides an effective seal with the patient due to its anatomical fit, but also allows the sealing member to be biased by its internal chamber against the patient, e.g., the patient's face, if an improved seal is required.

[0011] The patient contacting surface may provide an anatomical fit with the patient before the sealing member is deformed in use, i.e. the patient contacting surface may be anatomically shaped. To provide an anatomical fit, the patient contacting surface may have a leading portion, i.e. the portion that contacts the surface of the patient before the sealing member is deformed, which leading portion is anatomically shaped. This anatomical shape is determined at least in the direction in which the sealing member engages the surface of the patient, whereby the position of the leading portion of the patient contacting surface may vary in this direction, for example at different positions along the patient contacting surface. The leading portion of the patient contacting surface may have the shape of a closed loop, for example extending around a mask body of a respiratory mask, or a laryngeal mask airway or an airway tube of an endotracheal tube. The leading portion of the patient contacting surface and / or a centerline on the leading portion may have a varying position relative to a reference plane, such as a reference plane or a reference cylindrical plane, where the reference plane may be disposed perpendicular to the direction in which the sealing member engages the surface of the patient, or the direction of the overall pressure exerted by the sealing member on the surface of the patient. The leading portion of the patient contacting surface and / or a centerline on the leading portion may have a position that varies non-linearly relative to a reference surface.

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

[0013] The gas inlet port of the mould may protrude into the cavity, for example in the form of a nozzle. The gas inlet port may protrude relative to an inner circumferential surface of the mould that defines the cavity. The gas inlet port may have an outlet opening into the cavity, through which gas enters the cavity. When the sealing member is worn on a patient, the longitudinal axis of the sealing member may coincide with the longitudinal axis of the patient. In the case of a sealing member for a respiratory mask, the gas inlet port may be located at an end of the cavity that corresponds to the apex of the nose part of the sealing member for the respiratory mask.

[0014] The gas introduction port may have an outlet opening formed in a wall of the mold. The outlet opening may be spaced from the inner periphery of the mold that defines the cavity. The outlet opening may be approximately centrally located with respect to a cross-section of the cavity, for example, within 35-65% of the longest dimension of the cross-section of the cavity. By cross-section, we mean a surface of the cavity oriented approximately perpendicular to a central axis of the cavity that loops along the center of the cavity.

[0015] The gas introduction port can protrude relative to an inner periphery of the mold that defines the cavity, thereby forming an opening in the surrounding wall of the sealing member, which opening can be in fluid communication with the interior chamber of the sealing member.

[0016] According to a further aspect of the present invention, there is provided a method of manufacturing a sealing member for a respiratory interface device, the method comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold; (c) introducing a gas into the cavity of the mold through the gas introduction port; Including, thereby forming a sealing member for the respiratory interface device; The sealing member of the respiratory interface device includes an interior chamber at least partially surrounded by an elastically deformable surrounding wall formed from the polymer, the surrounding wall including a patient-contacting surface, and the gas introduction port protrudes relative to an inner circumferential surface of the mold defining the cavity, thereby forming an opening in the surrounding wall of the sealing member.

[0017] The opening may be in fluid communication with the interior chamber of the sealing member.

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

[0019] A gas introduction port for the cavity can be located adjacent to a polymer injection port for the cavity.

[0020] The polymer injected into the cavity of the mold can have a volume that is smaller than the volume of the cavity. During injection of the polymer, the polymer is soft enough to flow, for example in the form of a polymer melt. After injection of the polymer but before the introduction of the gas, the polymer can extend only partially along the cavity. The polymer can then have the form of a unitary structure that is separated from the end of the cavity opposite the end where the polymer injection port is located.

[0021] A polymer injection port for the cavity can be located at one end of the sealing member during manufacture, and polymer can flow from the polymer injection port in both directions along the cavity to form the sealing member.

[0022] The injected gas can guide, deform, and / or displace the polymer within the mold cavity to form the sealing member. The gas can apply pressure to the polymer to form the interior chamber and the polymer enclosure. The pressure applied by the gas can have a radial component that can guide, deform, or displace the polymer outwardly toward the interior surface of the cavity, thereby forming the enclosure of the sealing member. The pressure applied by the gas can have an axial component that can guide, deform, or displace the polymer axially along the cavity, away from the gas introduction port.

[0023] Introducing gas into the mold cavity through the gas inlet port can form a bubble of gas in the polymer extending from the gas inlet port. The gas inlet port can be located at one end of the sealing member during manufacture, and the internal chamber can be formed by gas flowing in both directions from the gas inlet port through the polymer and along the cavity. However, other configurations including multiple gas inlet ports in different regions of the cavity can be used.

[0024] The internal chamber can be filled with a gas during manufacture. The resulting enclosure wall can have a thickness of less than 4 mm, less than 3 mm, or less than 2.5 mm. The enclosure wall can have a substantially uniform thickness over at least a majority of the internal chamber, e.g., less than 20% variation from an average thickness over at least 80% of the surface area of ​​the enclosure wall.

[0025] Gas introduced into the cavity can also move the polymer along the cavity, for example toward the end of the cavity opposite the end where the polymer injection port and / or gas introduction port are located.

[0026] A polymer can be moved along said cavity having the shape of a closed loop in a direction opposite the polymer injection port and / or gas introduction port, such that the polymer has two branches advancing along the cavity, and the branches of the polymer can meet, join and bond to form a sealing member of the respiratory interface device extending along the closed loop.

[0027] The sealing member can have a solid portion, i.e., a portion without an internal chamber, which can be located at the end of the cavity opposite the gas inlet port. Thus, the internal chamber formed by the injected gas can have a first end and a second end, which can be separated by a continuous solid body of polymer, for example at the end of the respiratory interface device opposite the gas inlet port. The internal chamber can include a tapered end adjacent the solid portion of the sealing member.

[0028] The solid portion may provide greater resistance to deformation in one or more selected regions of the sealing member. For example, the solid portion may provide greater resistance to deformation in one or more selected regions of the sealing member of a respiratory mask, such as the chin region, thereby eliminating the need for separate reinforcement. Similarly, the solid portion may provide greater resistance to deformation in a distal region of a sealing cuff of a laryngeal mask airway, thereby reducing the risk of the sealing cuff collapsing upon insertion into a patient's airway, thereby eliminating the need for separate reinforcement.

[0029] One or more additional gas introduction ports can be provided to allow for the introduction of a gas having a pressure that balances the movement of the polymer along the cavity, and the gas introduced through the one or more additional gas introduction ports can be exhausted as the polymer moves along the cavity.

[0030] The interior chamber may be filled with a gas during manufacture, and this gas may 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 the gas or ambient air to enter and exit the interior 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 melt, and the injection unit may be moved into engagement with and fluid communication with the injection port of the cavity of the mold. The injection unit may then apply pressure to the polymer melt and inject the polymer melt into the cavity of the mold through the polymer injection port. If the polymer is a thermoplastic, the polymer melt in the cavity is cooled to solidify the polymer. If the polymer is a thermosetting polymer, the polymer may be heated in the injection unit to a temperature where it is soft enough to flow but not begin to harden, and the polymer melt in the cavity may be heated to begin to harden the polymer. Alternatively, in liquid injection molding, the polymer may not be a polymer melt, but a liquid mixture that may be at or below room temperature in the injection unit, and may be hardened in the mold, for example, by applying heat.

[0032] According to a further aspect of the present invention there is provided a method of manufacturing a sealing member for a respiratory interface device, the method comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold through the polymer injection port; (c) introducing a gas into the cavity of the mold through the gas introduction port; Including, This forms a sealing member for the respiratory interface device. This results in an internal chamber being formed within the cavity of the mold and within the sealing member, at least partially surrounded by an elastically deformable enclosure wall formed from the polymer, the enclosure wall including a patient contacting surface that provides an anatomical fit with the patient.

[0033] According to a further aspect of the present invention there is provided a method of manufacturing a sealing member for a respiratory interface device, the method comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold through the polymer injection port; (c) introducing a gas into the mold cavity through the gas inlet port once the mold cavity is at least partially filled with the polymer; Including, This forms a sealing member for the respiratory interface device. The sealing member of the respiratory interface device includes an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed from the polymer, the enclosure wall including a patient-contacting surface that provides an anatomical fit with a patient.

[0034] According to a further aspect of the present invention there is provided a method of manufacturing a sealing member for a respiratory interface device, the method comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold through the polymer injection port such that the cavity of the mold is only partially filled; (c) introducing a gas into the mold cavity through the gas inlet port once the mold cavity is at least partially filled with the polymer; Including, This forms a sealing member for the respiratory interface device. The interior chamber is thereby at least partially surrounded by a resiliently deformable enclosure wall formed from the polymer, the enclosure wall including a patient contacting surface that provides an anatomical fit with the patient.

[0035] According to a further aspect of the present invention there is provided a sealing member manufactured by any of the above defined methods.

[0036] According to a further aspect of the present invention there is provided a sealing member for a respiratory interface device comprising an internal chamber at least partially surrounded by an elastically deformable surrounding wall, the surrounding wall including a patient contacting surface having a shape that provides an anatomical fit with a patient, the sealing member including an opening in fluid communication with the internal chamber of the sealing member and with ambient air, whereby ambient air can pass through and exit the internal chamber in use.

[0037] The sealing member according to this aspect of the invention comprises an elastically deformable enclosure wall including a patient contact surface that provides an anatomical fit with the patient, in combination with an internal chamber at least partially surrounded by the elastically deformable enclosure wall, and an opening through which ambient air can enter and leave the internal chamber in use. This combination of features provides the sealing member with an effective seal with the patient due to its anatomical fit, but the internal chamber and the opening through which ambient air can enter and leave the internal chamber in use also allow the sealing member to be biased against the patient, e.g. the patient's face, if an improved seal is required. In particular, the internal chamber and the opening through which ambient air can enter and leave the internal chamber in use can provide the sealing member with a greater ability to deform for a given thickness of the elastically deformable enclosure wall compared to prior art inflatable sealing members. This allows for a thicker wall thickness than prior art inflatable sealing members that do not allow gas to leave the internal chamber in use, which can provide advantages including better retention of the anatomical shape during and after deformation, increased durability and reduced risk of damage, and a sealing member that does not need to be re-inflated before use. Furthermore, compared to prior art sealing members that are not inflatable, the configuration of this aspect of the present invention reduces the risk that the sealing member will expand and cause a leak when pressure is applied by the clinician.

[0038] Thus, the patient contacting surface of the sealing member may be formed with a predetermined anatomical shape.The patient contacting surface of the sealing member may have the shape of a closed loop.

[0039] If the sealing member is for a respiratory mask, the patient-contacting surface may generally conform to the patient's frontal plane in use, but may include a convex surface in the cheek region of the patient-contacting surface, and / or a concave surface circumferentially in the nose and / or chin region of the patient-contacting surface. The patient-contacting surface may include a laterally or radially convex surface. The circumferential convex surface of the patient-contacting surface may extend along the majority of the length of the mask, and the circumferential concave surface of the patient-contacting surface may extend along the width of the mask, for example at each end. The convex and / or concave curvature may result in the patient-contacting surface changing position relative to the patient's sagittal axis in use.

[0040] Where the sealing member is for a laryngeal mask airway 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 may be provided in the surrounding wall of the sealing member. The opening may be in fluid communication with the internal chamber of the sealing member. If multiple internal chambers are provided, an opening may be provided in the surrounding wall of the sealing member for each internal chamber.

[0042] In a respiratory mask, the openings in the sealing member can provide fluid communication between the internal chamber of the sealing member and the ambient air. In this embodiment, if an improved seal is required, in use, the user can urge the sealing member against the patient's face, for example by applying pressure to the respiratory device interface towards the patient's face. The sealing member and the internal chamber are compressed and air escapes from the internal chamber, but the resilience of the sealing member is sufficient such 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 be always open or may be opened by the flow of air into or out of the internal chamber of the sealing member. The opening may be valveless having a closed configuration. In some embodiments, the opening may include a valve that regulates the flow of ambient air into or out of the internal chamber of the sealing member.

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

[0045] The sealing member may have the shape of a loop. An interior chamber of the sealing member may be continuous and extend around at least a majority of the loop. The interior chamber may have a central longitudinal axis that follows a curved path. The curved path may extend around at least a majority of the loop.

[0046] The loop may be circular, elliptical, triangular or oval in nature. For example, the sealing member may be the sealing membrane of the respiratory interface device and the outer surface may be the patient-contacting surface. An opening may be formed in the patient-contacting surface to receive the nasal and / or mouth regions of the patient's face. The patient-contacting surface and / or its opening may be approximately triangular in nature, i.e., conforming 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 length of the loop. The internal chamber can extend around 80-100%, 80-90%, or 90-100% of the length of the loop. The length of the loop can refer to the length of the central axis of the loop. The loop can extend over an angle of 360 degrees, and the internal chamber can extend over an angle of 300-360 degrees around the loop, an angle of 300-330 degrees around the loop, or an angle of 330-360 degrees around the loop. In some examples, the internal chamber can extend around the entire loop, i.e., the internal chamber can form a loop.

[0048] The cross-sectional area of ​​the internal chamber may vary, for example, by varying the location and / or thickness of the surrounding wall.

[0049] The sealing member can have one or more solid portions, i.e., portions without an internal chamber. The internal chamber can have a first end and a second end, which can be separated by one or more solid portions of the sealing member. The internal chamber can include a tapered end adjacent the solid portion of the sealing member.

[0050] According to a further aspect of the present invention, a sealing member of a respiratory interface device is provided, the sealing member including an internal chamber at least partially surrounded by an elastically deformable surrounding wall, the surrounding wall including a patient-contacting surface, the internal chamber having a first end and a second end separated by one or more solid portions of the sealing member.

[0051] The one or more solid portions of the sealing member separating the first and second ends of the interior chamber may be a single continuous solid portion.

[0052] The one or more solid portions can provide greater resistance to deformation in one or more selected regions of the sealing member. For example, the one or more solid portions can provide greater resistance to deformation in one or more selected regions of the sealing member of a respiratory mask, such as the chin region, thereby eliminating the need for separate reinforcement. Similarly, the one or more solid portions can provide greater resistance to deformation in a distal region of a sealing cuff of a laryngeal mask airway, thereby reducing the risk of the sealing cuff collapsing upon insertion into a patient's airway, thereby eliminating the need for separate reinforcement.

[0053] It has also been found that, compared with the prior art methods for manufacturing an expandable sealing member, such as the blow molding method, the method for manufacturing a sealing member for a respiratory interface device according to the present invention can manufacture a respiratory interface device with fewer assembly steps, shorter manufacturing time, and reduced manufacturing costs. In particular, it has been found that the method for manufacturing a sealing member for a respiratory interface device according to the present invention can be incorporated into a manufacturing process in which the sealing member is fixed to the body of the respiratory interface device in the sealing member forming step, such as a two-shot molding or overmolding process. This has not been possible in the past when manufacturing a respiratory interface device having an expandable sealing member.

[0054] According to a further aspect of the present invention, there is provided a sealing member of a respiratory interface device, the sealing member including an interior chamber at least partially surrounded by an elastically deformable surrounding wall, the surrounding wall including a patient contacting surface, the patient contacting surface having a shape that provides an anatomical fit with a patient.

[0055] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device comprising a method of manufacturing a sealing member of a respiratory interface device as defined above.

[0056] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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 a first polymer into the first cavity of the mold through the first polymer injection port to form a body portion of the respiratory interface device; (c) injecting a second polymer into the second cavities of the one or more molds through the second polymer injection port and introducing a gas into the second cavities of the one or more molds through the gas introduction port to form a sealing member of the respiratory interface device, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient-contacting surface determined by the second cavities of the one or more molds and having a shape that provides an anatomical fit with a patient; Including, The body portion and the sealing member of the respiratory interface device may be formed in any order, whereby one of the body portion or the sealing member is an earlier formed portion and the other of the body portion and the sealing member is a later formed portion, and during injection molding of the later formed portion, the later formed portion engages with the earlier formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together.

[0057] The method of manufacturing a respiratory interface device according to the present invention is advantageous because it may allow for fewer assembly steps, reduced manufacturing time, and reduced manufacturing costs compared to prior art methods of forming a respiratory interface device having an inflatable portion.

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

[0059] The body of the respiratory interface device formed by the method according to the invention may include the flow paths of the respiratory interface device and may also include connectors for connecting the flow paths of the device to respiratory equipment such as a breathing tube and / or a source of breathing gas.

[0060] The body of the respiratory interface device will generally be the first part formed and the sealing member of the respiratory interface device will generally be the last part formed, however, in some embodiments it may be advantageous for the sealing member of the respiratory interface device to be the first part formed and the body of the respiratory interface device to be the last part formed.

[0061] One or more molds are configured having a first cavity, a second cavity, and a gas inlet port opening into the second cavity such that a later-formed portion of the respiratory interface device can be positioned adjacent to or within a cavity (either the first cavity or the second cavity) that forms the later-formed portion of the respiratory interface device, such that, during injection molding of the later-formed portion, the later-formed portion can be engaged with the earlier-formed portion in a manner that secures the body and sealing member of the respiratory interface device together. During injection molding of the later-formed portion, the later-formed portion can be brought into contact with the earlier-formed portion.

[0062] The fastening between the body portion and the sealing member can be by one or more of a chemical bond and a mechanical bond. The bond can be formed immediately after injection molding of the subsequently formed portion of the respiratory interface device, which eliminates the need for an additional assembly step to fasten the body portion and the sealing member together.

[0063] The second polymer may contact a boundary region of a body portion of a respiratory interface device, such as a mask body or an airway tube, which may include a periphery. If the second polymer contacts a single boundary region of a body portion of a respiratory interface device, the interior chamber may be surrounded only by an enclosure wall defined by the second polymer.

[0064] The gas introduction port may protrude relative to an inner circumferential surface of the mold defining either the first cavity or the second cavity, thereby forming the opening in either the main body portion of the respiratory interface device and / or the surrounding wall of the sealing member of the respiratory interface device.

[0065] A gas inlet port in the mold can protrude into the second cavity relative to an inner periphery of the mold that defines the second cavity.

[0066] In this embodiment, the previously formed portion may be formed in a first or second cavity of the mold in a first shot configuration, and then the mold may be moved to a second shot configuration such that the previously formed portion of the respiratory interface device is disposed adjacent to the other of the first or second cavity forming the later formed portion of the respiratory interface device, and during injection molding of the later formed portion, the later formed portion engages with the previously formed portion in a manner that secures the body portion and sealing member of the respiratory interface device together. For example, in the second shot configuration of the mold, a surface of the body portion of the respiratory interface device, such as a periphery of the body portion or a border area of ​​a surface of the body portion adjacent the periphery, may be exposed to the interior of the cavity forming the later formed portion of the respiratory interface device. It should be noted that although the first cavity may be defined by the mold in a first shot configuration and the second cavity may be defined by the mold in a second shot configuration, the first cavity and the second cavity are not necessarily defined by the mold at the same time. The mold can therefore be housed in a single injection molding machine, a process commonly referred to as two-shot molding.

[0067] Alternatively, the 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 previously formed portion of the respiratory interface device in the first mold or the second mold, the first mold or the second mold may be opened and the previously formed portion of the respiratory interface device may be transferred to the other of the first mold and the second mold such that the previously formed portion is disposed in the cavity forming the later formed portion of the respiratory interface device, and during injection molding of the later formed portion, the later formed portion engages with the previously formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together. Thus, the first and second molds may be provided in two separate injection molding machines, and this process is commonly referred to as overmolding.

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

[0069] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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) placing the mold in a first shot configuration; (c) injecting a first polymer into a first cavity of the mold through a first polymer injection port to form a body portion of the respiratory interface device; (d) placing the mold in a second shot configuration such that the body portion of the respiratory interface device is located adjacent to the second cavity; (e) injecting a second polymer into the second cavity of the mold through a second polymer injection port and introducing a gas into one or more of the second cavities of the mold through a gas introduction port to form a sealing member of the respiratory interface device, wherein the sealing member engages the body portion of the respiratory interface device in a manner that secures the body portion and the sealing member together during injection molding of the sealing member, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable surrounding wall formed of the second polymer, the surrounding wall including a patient-contacting surface that is dictated by the second cavity of the mold and has a shape that provides an anatomical fit with the patient; Includes.

[0070] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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) injecting a first polymer into a first cavity of a first mold through a first polymer injection port to form a body portion of a respiratory interface device; (c) transferring the body portion of the respiratory interface device to a second mold such that the body portion of the respiratory interface device is disposed within or adjacent to the second cavity; (d) injecting a second polymer into the second cavity of the second mold through the second polymer injection port and introducing a gas into the second cavity of the second mold through the gas introduction port to form a sealing member of the respiratory interface device, wherein the sealing member engages the body portion of the respiratory interface device in a manner that secures the body portion and the sealing member together during injection molding of the sealing member, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable surrounding wall formed of the second polymer, the surrounding wall including a patient-contacting surface that is shaped by the one or more mold second cavities to provide an anatomical fit with the patient; Includes.

[0071] The gas inlet port of the mold can protrude into the second cavity. The gas inlet port can protrude relative to the inner peripheral surface of the mold that defines the second cavity. Alternatively, the gas inlet port can protrude through the body of the respiratory mask into the second cavity. In a two-shot molding process, the gas inlet port can protrude relative to the inner peripheral surface of the mold that defines the first cavity in a first shot configuration of the mold, such 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 inlet port penetrates the first polymer in the first cavity, and the gas inlet port can protrude through the body of the respiratory mask into the second cavity in a second shot configuration of the mold.

[0072] The gas inlet port may have an exit opening into the second cavity through which gas enters the second cavity. The exit opening of the gas inlet port may be aligned with a longitudinal axis of the second cavity and thus with a longitudinal axis of the respiratory interface device. When the respiratory interface device is worn on a patient, the longitudinal axis of the respiratory interface device may be aligned with a longitudinal axis of the patient. In the case of a respiratory mask, the gas inlet port may be located at an end of the second cavity corresponding to the apex of the nose portion of the respiratory mask.

[0073] During manufacture, an opening to the internal chamber can be formed around the gas inlet port, which allows 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 can be at least partially surrounded by a wall having a first layer defined by a first polymer and a second layer defined by a second polymer, and the opening to the internal chamber can be formed in the wall.

[0074] The gas introduction port can protrude relative to an inner peripheral surface of the mold that defines either the first cavity or the second cavity, thereby forming an opening in either the body portion of the respiratory device and / or the surrounding wall of the sealing member of the respiratory interface device. The opening can be in fluid communication with an internal chamber of the sealing member of the respiratory interface device.

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

[0076] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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 a first polymer into the first cavity of the mold through the first polymer injection port to form a body portion of the respiratory interface device; (c) injecting a second polymer into the second cavities of the one or more molds through the second polymer injection port and introducing a gas into the second cavities of the one or more molds through the gas introduction port to form a sealing member of the respiratory interface device, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient-contacting surface; Including, the body portion and the sealing member of the respiratory interface device may be formed in any order, whereby one of the body portion or the sealing member is an earlier formed portion and the other of the body portion and the sealing member is a later formed portion, and during injection molding of the later formed portion, the later formed portion engages with the earlier formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together; The gas introduction port protrudes relative to the inner peripheral surface of the mold defining the first cavity or the second cavity, thereby forming an opening in the main body portion of the respiratory device and / or the surrounding wall of the sealing member of the respiratory interface device, the opening being fluidly connected to the internal chamber of the sealing member of the respiratory interface device.

[0077] Methods according to the invention may use one or more mould tools defining one or more moulds having a first cavity and a second cavity, each cavity being defined by an inner wall of the mould.

[0078] The gas inlet port of the mold can protrude into the second cavity. The gas inlet port can protrude relative to an inner periphery of the mold that defines the second cavity. Alternatively, the gas inlet port can protrude through the body of the respirator into the second cavity.

[0079] The method of manufacturing the respiratory interface device may be a two-shot molding process or an overmolding process, and in both of these processes, the body portion of the respiratory interface device is generally the first formed part and the sealing member of the respiratory interface device is generally the second formed part, and these two embodiments are defined separately below.

[0080] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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) placing the mold in a first shot configuration; (c) injecting a first polymer into a first cavity of the mold through a first polymer injection port to form a body portion of the respiratory interface device; (d) placing the mold in a second shot configuration such that the body portion of the respiratory interface device is located adjacent to the second cavity; (e) injecting a second polymer into the second cavity of the mold through a second polymer injection port and introducing a gas into one or more of the second cavities of the mold through a gas introduction port to form a sealing member of the respiratory interface device, wherein the sealing member engages the body portion of the respiratory interface device in a manner that secures the body portion and the sealing member together during injection molding of the sealing member, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable surrounding wall formed of the second polymer, the surrounding wall including a patient-contacting surface that is dictated by the second cavity of the mold and has a shape that provides an anatomical fit with the patient; Including, The gas introduction port protrudes relative to the inner peripheral surface of the mold defining the first cavity or the second cavity, thereby forming an opening in the main body portion of the respiratory device and / or the surrounding wall of the sealing member of the respiratory interface device, the opening being fluidly connected to the internal chamber of the sealing member of the respiratory interface device.

[0081] The gas inlet port can protrude relative to an inner peripheral surface of the mold that defines the second cavity. Alternatively, the gas inlet port can protrude relative to an inner peripheral surface of the mold that defines the first cavity in a first shot configuration of the mold, such that when the first polymer is injected into the first cavity of the mold to form the body portion of the respiratory interface device, the gas inlet port penetrates the first polymer in the first cavity, and the gas inlet port can protrude through the body portion of the respiratory mask into the second cavity in a second shot configuration of the mold.

[0082] According to a further aspect of the present invention there is provided a method of manufacturing a respiratory interface device, the method comprising: (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) injecting a first polymer into a first cavity of a first mold through a first polymer injection port to form a body portion of a respiratory interface device; (c) transferring the body portion of the respiratory interface device to a second mold such that the body portion of the respiratory interface device is disposed within or adjacent to the second cavity; (d) injecting a second polymer into the second cavity of the second mold through the second polymer injection port and introducing a gas into the second cavity of the second mold through the gas introduction port to form a sealing member of the respiratory interface device, wherein the sealing member engages the body portion of the respiratory interface device in a manner that secures the body portion and the sealing member together during injection molding of the sealing member, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable surrounding wall formed of the second polymer, the surrounding wall including a patient-contacting surface that is shaped by the one or more mold second cavities to provide an anatomical fit with the patient; Including, The gas introduction port of the mold can protrude into the second cavity relative to an inner circumferential surface of the mold that defines the second cavity, thereby forming an opening in the surrounding wall of the sealing member of the respiratory interface device, the opening being in fluid communication with the internal chamber of the sealing member of the respiratory interface device.

[0083] In some embodiments, the gas introduction port can protrude through the body of the respiratory mask into the second cavity, such as through an opening formed during injection molding in the first mold.

[0084] Each cavity may have a single polymer injection port with an exit opening into the cavity through which the polymer may enter the cavity. The exit opening of the polymer injection port may be aligned with the longitudinal axis of the second cavity and thus with the longitudinal axis of the respiratory interface device. When the respiratory interface device is worn on a patient, the longitudinal axis of the respiratory interface device may be aligned with the longitudinal axis of the patient. In the case of a respiratory mask, the polymer injection port may be located at an end of the second cavity corresponding to the apex of the nose portion of the respiratory mask. The exit opening may be formed in a wall of the mold or may be flush with the inner periphery of the mold that defines 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 process of injection molding differs depending on whether the polymer is a thermoplastic or a thermoset. 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] A first polymer can be provided to a first injection unit. The first polymer can be heated in the injection unit until the polymer is soft enough to flow, thereby forming a first polymer melt, and the first injection unit can be moved into engagement with and fluid communication with an injection port of a first cavity of the mold.

[0087] A second polymer can be provided to a second injection unit, the second polymer can be heated in the injection unit until the polymer is soft enough to flow, thereby forming a second polymer melt, and the second injection unit can be moved into engagement with and fluid communication with an injection port of a second cavity of the mold.

[0088] A first polymer is injected into a first cavity of the mold to form a body portion of a respiratory interface device, such as a mask body of a respiratory mask, or an airway tube of a laryngeal mask airway 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 can be different.

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

[0090] If 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 completed and before the polymer for the earlier formed portion is completely solidified. If an overmolding process is used, the earlier formed portion of the respiratory interface device can be nearly or completely solidified before being transferred into the cavity that will form the later formed portion of the respiratory interface device.

[0091] If the polymer is a thermoplastic, the polymer melt is heated above ambient temperature before injection so that it can flow, and is kept at an elevated temperature relative to ambient during the injection step. The polymer melt solidifies when it has cooled sufficiently. Ambient temperature means typical room temperature, e.g. 15-25°C.

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

[0093] According to a further aspect of the present invention there is provided a respiratory interface device manufactured by the method defined above.

[0094] For example, the sealing member of the respiratory interface device may be secured to the body portion of the respiratory interface device by a chemical or mechanical bond in the form provided by either two-shot molding or overmolding. The bond between the body portion and the sealing member may be permanent.

[0095] The patient contacting surface of the sealing member may have the shape of a closed loop. If the sealing member is for a respiratory mask, the patient contacting surface may generally conform to the patient's frontal plane in use, but may include a circumferential convexity in cheek regions of the patient contacting surface, and / or a concavity in nose and / or chin regions of the patient contacting surface. The patient contacting surface may include a laterally or radially convexity. The circumferential convexity of the patient contacting surface may extend along a majority of the length of the mask. The convex and / or concave curvature may result in the patient contacting surface changing position relative to the sagittal axis of the patient in use.

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

[0097] The respiratory interface device may be a non-invasive interface device in which the sealing member seals the flow passage, e.g., the mask body, against the patient's face, thereby forming an effective fluid connection between the flow passage and the patient's mouth and / or nose, or the respiratory interface device may be an invasive interface device in which the sealing member seals the flow passage against an interior surface of the patient's airway, thereby forming an effective fluid connection between the flow passage of the device, e.g., the airway tube, and the patient's airway.

[0098] The sealing member and / or the patient contacting surface may be configured as a continuous loop, which may extend around the entrance to the flow passage of the respiratory interface device.

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

[0100] The respiratory interface device may be an endotracheal tube or a supraglottic airway such as a laryngeal mask airway, where the body of the respiratory interface device defines an airway tube and the sealing member is for engaging the patient's larynx or trachea and may have the form of a sealing cuff. The body of the respiratory interface device may also include a connector for connecting the airway tube of the device to respiratory equipment such as a breathing tube and / or a source of breathing gas. The connector may be located at an end of the flow passage defined by the airway tube opposite the end where the sealing member is located.

[0101] The sealing member can have one or more solid portions, i.e., portions without an internal chamber. The internal chamber can have a first end and a second end, which can be separated by one or more solid portions of the sealing member. The internal chamber can include a tapered end adjacent the solid portion of the sealing member.

[0102] According to a further aspect of the present invention, there is provided a respiratory interface device including a respiratory interface device body portion formed from a first polymer and a respiratory interface device sealing member formed from a second polymer, the respiratory interface device sealing member being secured to the respiratory interface device body portion, the respiratory interface device sealing member including an internal chamber at least partially surrounded by an elastically deformable surrounding wall formed from the second polymer, the surrounding wall including a patient contacting surface, 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, the sealing member of the respiratory interface device may be secured to the body portion of the respiratory interface device by a chemical or mechanical bond in the form provided by either two-shot molding or overmolding. The bond between the body portion and the sealing member may be permanent.

[0104] The or each solid portion of the sealing member may be a single, continuous solid body of the second polymer. One or more solid portions of the sealing member separating the first and second ends of the interior chamber may be a single, continuous solid body of the second polymer.

[0105] The one or more solid portions can provide greater resistance to deformation in one or more selected regions of the respiratory interface device. For example, the one or more solid portions can provide greater resistance to deformation in one or more selected regions of the sealing member of the respiratory mask, such as the chin region, thereby eliminating the need for separate reinforcement. Similarly, the one or more solid portions can provide greater resistance to deformation in a distal region of the sealing cuff of a laryngeal mask airway, thereby reducing the risk of the sealing cuff collapsing upon insertion into a patient's airway, thereby eliminating the need for separate reinforcement.

[0106] The respiratory interface device may include an opening in an enclosing wall of the sealing member and / or in a wall of a body portion of the respiratory interface device, such as a mask body, such that the opening is in fluid communication with an internal chamber of the sealing member of the respiratory interface device to allow ambient air to enter or exit the internal chamber in use. This feature may improve the compliance of the sealing member when urged against a patient's surface in use, and therefore improve the seal achieved with that surface.

[0107] According to a further aspect of the present invention, there is provided a respiratory interface device including a body portion of the respiratory interface device formed from a first polymer and a sealing member of the respiratory interface device formed from a second polymer, the sealing member of the respiratory interface device secured to the body portion of the respiratory interface device, the sealing member of the respiratory interface device including an internal chamber at least partially surrounded by an elastically deformable surrounding wall formed from the second polymer, the surrounding wall including a patient-contacting surface, and the respiratory interface device including an opening in the surrounding wall of the sealing member and / or in a wall of the body portion of the respiratory interface device, whereby the opening is in fluid communication with the internal chamber of the sealing member of the respiratory interface device to allow ambient air to pass through and exit the internal chamber during use.

[0108] The respiratory interface device according to this aspect of the invention comprises an elastically deformable enclosure wall including a patient contact surface that provides an anatomical fit with the patient, in combination with an internal chamber at least partially surrounded by the elastically deformable enclosure wall, and an opening through which ambient air can enter and leave the internal chamber in use. This combination of features provides the sealing member with an effective seal with the patient due to its anatomical fit, but the internal chamber and the opening through which ambient air can enter and leave the internal chamber in use can also bias the sealing member against the patient, e.g., the patient's face, if an improved seal is required. In particular, the internal chamber and the opening through which ambient air can enter and leave the internal chamber in use can provide the sealing member with a greater ability to deform for a given thickness of the elastically deformable enclosure wall compared to prior art inflatable sealing members. This allows for a thicker wall thickness than prior art inflatable sealing members that do not allow gas to leave the internal chamber in use, which can provide advantages including better retention of the anatomical shape during and after deformation, increased durability and reduced risk of damage, and a sealing member that does not need to be re-inflated before use. Furthermore, compared to prior art sealing members that are not inflatable, the configuration of this aspect of the present invention reduces the risk that the sealing member will expand and cause a leak when pressure is applied by the clinician.

[0109] The respiratory interface device may be a respiratory mask. The opening may be always open or may be opened by the flow of air into and out of the internal chamber of the sealing member. The opening may be valve-free with a closed configuration. In some embodiments, the opening may include a valve that regulates the flow of ambient air into and out of 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 respiratory interface device and any wall of the underlying sealing member, the risk of the opening being blocked during use may be reduced.

[0110] In this configuration, the gas pressure within the internal chamber can be atmospheric, but the surrounding wall can nevertheless be rigid enough to retain its shape during handling, for example unless forced against a patient's face with sufficient pressure during use.

[0111] When a user urges the sealing member against the patient's surface, for example by applying pressure to the respiratory device interface towards the patient's surface, the sealing member and the internal chamber are compressed and air escapes from the internal chamber, however the sealing member is sufficiently rigid that the internal chamber does not completely collapse upon compression, i.e. a gap remains between the opposing internal surfaces of the enclosing wall, and the enclosing wall and the internal chamber return to their original shape when the pressure is removed.

[0112] According to a further aspect of the present invention, there is provided a respiratory interface device including a respiratory interface device body portion formed from a first polymer and a respiratory interface device sealing member formed from a second polymer, the respiratory interface device sealing member being secured to the respiratory interface device body portion, the respiratory interface device sealing member including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall including a patient contacting surface, the patient contacting surface providing an anatomical fit with a patient.

[0113] According to a further aspect of the present invention there is provided a breathing circuit including a source of breathing gas, a patient interface device as defined above, and a breathing tube extending between the source of breathing gas and the patient interface device.

[0114] Possible embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0115] [Figure 1]FIG. 2 is a rear view of a mask body formed in the first shot of a two-shot molding method according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a schematic diagram of a first stage of a second shot of a two-shot molding process according to a first embodiment of the present invention, in which the polymer melt of the second shot is introduced. [Diagram 3] FIG. 2 is a schematic diagram of a second stage of the second shot of the two-shot molding method according to the first embodiment of the present invention, where the polymer melt of the second shot is fully introduced. [Figure 4] FIG. 2 is a schematic diagram of a third stage of the second shot of the two-shot molding method according to the first embodiment of the present invention, in which gas is partially introduced into the polymer melt of the second shot. [Diagram 5] FIG. 2 is a schematic diagram of a fourth stage of the second shot of the two-shot molding method according to the first embodiment of the present invention, where gas has been fully introduced into the polymer melt of the second shot. [Figure 6] 1 is a respirator formed by a two-shot molding method according to a first embodiment of the present invention, showing the polymer and gas inlets for the second shot. [Figure 7] FIG. 13 is a first perspective view of a respiratory mask formed by a two-shot molding process in accordance with a second embodiment of the present invention. [Figure 8] FIG. 13 is a second perspective view of a respiratory mask formed by a two-shot molding method according to a second embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 producing respiratory masks.

[0117] An injection molding process typically involves an apparatus with injection units each including an outlet nozzle, a tool defining a mold, and a clamping unit arranged to move the mold components between a closed configuration in which a polymer melt can be injected into the mold cavity, and an open configuration in which the molded article can be removed from the mold.

[0118] The mold tool defines a mold with a first cavity and a second cavity, each cavity having a polymer injection port for introducing a polymer melt into the cavity, each cavity being defined by an interior wall of the mold.

[0119] A first injection unit for the first shot of the two-shot injection molding process is provided with a first polymer melt, which in this embodiment is a thermoplastic polypropylene (PP). The first polymer melt is heated in the injection unit until it is soft enough to flow, and an outlet nozzle of the injection unit is moved into engagement and fluid communication with an injection port of a first cavity of a mold.

[0120] Additionally, a second injection unit for the second shot of the two-shot injection molding process is provided with a second polymer melt, which in this embodiment is a thermoplastic elastomer (TPE) of a thermoplastic resin, which is heated in the second injection unit until it is soft enough to flow, and an outlet nozzle of the second injection unit is moved into engagement and fluid communication with an injection port of a second cavity of the mold.

[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. Then, the first injection unit applies pressure to the first polymer melt 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 melt into the first cavity of the mold through the outlet nozzle and the polymer injection port. Then, while maintaining the pressure applied to the polymer melt, cooling of the polymer melt in the first cavity is started, and the polymer melt is partially solidified.

[0122] The polymer melt injected into the first cavity takes the form of a mask body 10. This mask body is shown in Figure 1, without the mold shown for clarity.

[0123] The mask body 10 includes 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, e.g., 22 mm in diameter, for connection to a breathing circuit. The tapered wall 12 is generally dome-shaped with a mouth portion having a generally circular cross-section in a plane that corresponds in use to the face of the patient, i.e., the frontal plane, and a narrowed nose portion that is generally triangular in shape and has a rounded apex for engaging the bridge of the patient's nose. In the mask body shown in FIG. 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 to 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 gripped by a user, e.g., in a pinching motion.

[0124] Once the mask body 10 is formed in a partially solidified state in the first shot of the two-shot injection molding process, the mold is then moved into a second shot configuration, whereby the second cavity of the mold is in fluid communication with the periphery 16 of the mask body 10 and a boundary region of the surface of the mask body 10 adjacent the periphery 16.

[0125] In the second shot of the method according to the first embodiment of the present invention, while the mask body 10 is in a partially solidified state, the second injection unit applies pressure to the polymer melt, for example using a piston and cylinder arrangement, to inject the second polymer melt into the second cavity of the mould through the outlet nozzle and polymer injection port. A blowing agent may be mixed with the second polymer melt of the second injection unit before applying pressure to inject into the second cavity of the mould, which can ensure a more uniform progression of the gas injected through the mould cavity. This method is further described in UK Patent Application No. 2013108.2.

[0126] 2 shows the second polymer melt 20 partially introduced into the second cavity, and FIG. 3 shows the second polymer melt 20 completely introduced into the second cavity. The second polymer melt 20 only partially fills the second cavity as shown in FIG. 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 FIG. 6), and the second cavity extends from the polymer injection port 28 in both directions around the periphery 16 of the mask body 10, so that the second polymer melt 20 flows from the polymer injection port 28 along the second cavities in the two branches 21, 22 and extends into the second cavities in each branch 21, 22 at approximately the same distance.

[0127] Once the second polymer melt 20 has been completely introduced into the second cavity, partially filling the second cavity, nitrogen gas 30 is introduced into the second polymer melt 20 in the second cavity via a gas introduction port 38 (see FIG. 6 ). The gas introduction port 38 is located adjacent to and oriented perpendicular to the polymer injection port 28 for the second cavity. The gas introduction port 38 extends from a wall of the second cavity into a central region of the second cavity such that the gas forms a bubble in the second polymer melt 20 in the second cavity.

[0128] Additionally, since the gas inlet port 38 is located at the apex of the nose portion of the mask body 10 and the second cavities extend in both directions from the gas inlet port 38 around the periphery 16 of the mask body 10, bubbles of gas 30 flow from the gas inlet port 38 along the central axis of the second polymer melt 20 within the second cavities of the two branches 31, 32.

[0129] FIG. 4 shows the gas 30 partially introduced into the second polymer melt 20 in the second cavity, and FIG. 5 shows the gas completely introduced into the second polymer melt 20 in the second cavity.

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

[0131] Once the respirator sealing cushion 42 is formed, the pressure exerted on the polymer melt by the gas 30 is maintained while the mask body 10 and sealing cushion 42 are cooled and fully solidified, thereby bonding the second polymer to the border areas and periphery of the mask body 10 and bonding the mask body 10 and sealing cushion 42 of the respirator together. Thus, no additional assembly steps, such as gluing, are required to secure the mask body 10 and sealing cushion 42 together.

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

[0133] The respirator sealing cushion 42 includes a thin enclosure wall that surrounds a gas-filled interior chamber 44. Additionally, because the gas inlet port 38 extends from the wall of the second cavity into the central region of the second cavity, the wall of the respirator sealing cushion 42 forms around the gas inlet port 38, thereby providing an opening in the wall of the respirator sealing cushion 42 when the respirator is removed from the mold. This opening in the wall of the respirator sealing cushion 42 provides fluid communication between the gas-filled interior chamber 44 of the respirator sealing cushion 42 and the ambient air.

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

[0135] In the respiratory mask 100 formed by the second embodiment of the method according to the present invention, the opening 138 formed by the gas inlet port is located in the wall of the mask body 112 and the underlying sealing cushion 142, rather than in the deformable wall of the sealing cushion 142 extending from the mask body 112. This location of the opening 138 is achieved by providing a mold in which the gas inlet port 38 extends from the wall of the first cavity of the mold to a central region of the second cavity of the mold in the second shot configuration 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 inlet port 38. In the second shot configuration of the mold, the gas inlet 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, a wall of the sealing cushion 142 underlying the adjacent wall of the mask body 112 is formed around the gas inlet port 38. Thus, when the respirator 100 is removed from the mold, an opening 138 is formed in the mask body 112 of the respirator 100 and the underlying wall of the sealing cushion 142. This opening 138 provides fluid communication between the gas-filled interior chamber of the sealing cushion 42 of the respirator 100 and the ambient air.

[0136] The third embodiment of the method according to the present invention uses an overmolding process. This differs from the first and second embodiments, which are two-shot molding processes, in that the mask body (substrate) formed from the first polymer is generally nearly 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 by the second polymer is fixed to the mask body formed by the first polymer by one or more of chemical and mechanical bonds.

[0137] Furthermore, any of the first, second, and third embodiments can be used with a thermosetting polymer, for example, for the sealing member. For example, liquid silicone rubber (LSR) can be the second polymer for forming the sealing member. However, when using a thermosetting polymer, the injection molding step and related equipment are different from those described above, since the thermosetting polymer generally requires heat to initiate curing. For liquid silicone rubber, a liquid injection molding (LIM) process is generally used.

[0138] Commonly used materials in the LIM process are silicone and acrylic. In the LIM process, a base forming plastic, which can be reinforced with additives and fibers, and a catalyst are pumped together. They are pumped in a 1:1 ratio into a static mixer where the mixing reaction occurs to form, for example, liquid silicone rubber (LSR). The outlet nozzle of the injection unit is moved to engage and fluidly communicate with the injection port of the mold cavity.

[0139] The liquid mixture is then injected into the mold cavity. Injection of the gas and formation of the sealing member are the same as described above for thermoplastics. However, the polymer is not cooled to solidify. Instead, the mold is heated, for example to a temperature of 180-200°C, to initiate curing. Once the polymer has cured, the respiratory interface device can be removed from the mold.

[0140] The following are appended claims to this disclosure. (Additional note 1) 1. A method of manufacturing a sealing member for a respiratory interface device, comprising: (a) providing a mold having a cavity, a polymer injection port, and a gas introduction port; (b) injecting a polymer into the cavity of the mold through the polymer injection port; (c) introducing a gas into the cavity of the mold through the gas introduction port; Including, This forms a sealing member for the respiratory interface device. The method, wherein the sealing member of the respiratory interface device includes an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed from the polymer, the enclosure wall including a patient-contacting surface, the patient-contacting surface having a shape determined by the cavity of the mold and providing an anatomical fit with a patient. (Additional note 2) 2. The method of claim 1, wherein the patient contacting surface has a leading portion that is a portion of the sealing member that contacts the surface of the patient prior to deformation of the sealing member, the leading portion being anatomically shaped at least in a direction in which the sealing member engages the surface of the patient, such that a position of the leading portion of the patient contacting surface varies in this direction at different positions along the patient contacting surface. (Additional note 3) 3. The method of claim 2, wherein the leading portion of the patient contacting surface and / or a centerline on the leading portion has a varying position relative to a reference plane, which may be a reference plane or a reference cylindrical surface, the reference plane being oriented perpendicular to a direction in which the sealing member engages the patient's surface or a direction of overall pressure applied by the sealing member to the patient's surface. (Additional note 4) 4. The method of any one of claims 1 to 3, wherein the gas inlet port of the mold is connected to a gas source, and the gas has a pressure sufficient to induce, deform, and / or displace the polymer to form the sealing member within the cavity of the mold. (Additional note 5) 5. The method according to any one of appended items 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 spaced apart from an inner circumferential surface of the mold that defines the cavity. (Additional note 6) The method according to any one of appended items 1 to 5, wherein the gas introduction port protrudes relative to an inner circumferential surface of the mold that defines the cavity, thereby forming an opening in the surrounding wall of the sealing member, and the opening is in fluid communication with the internal chamber of the sealing member. (Additional note 7) 7. The method according to any one of claims 1 to 6, wherein a polymer is injected into the cavity of the mold through the polymer injection port such that the cavity of the mold is only partially filled. (Additional note 8) 8. The method of claim 7, wherein the polymer injected into the cavity of the mold has a volume that is smaller than the volume of the cavity, such that after injection of the polymer but before introduction of gas, the polymer extends only partially along the cavity in the form of a unitary structure separated from the end of the cavity opposite the end of the cavity where the polymer injection port is located. (Additional note 9) 9. The method according to any one of claims 1 to 8, wherein the gas is introduced into the cavity of the mold through the gas inlet port once the cavity of the mold is at least partially filled with the polymer. (Additional note 10) The method according to any one of claims 1 to 9, wherein the internal chamber is formed within the sealing member in the cavity of the mold, the internal chamber being at least partially surrounded by an elastically deformable surrounding wall formed of the polymer. (Additional note 11) 11. The method according to any one of claims 1 to 10, wherein during manufacture, the polymer injection port for the cavity is located at one end of the sealing member, and the sealing member is formed by flowing the polymer from the polymer injection port in both directions along the cavity. (Additional note 12) the gas applies pressure to the polymer to form the interior chamber and the surrounding wall of the polymer; 12. The method according to any one of claims 1 to 11, wherein the pressure applied by the gas has a radial component that guides, deforms or moves the polymer outwardly towards an interior surface of the cavity, thereby forming the enclosing 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 and away from the gas introduction port. (Additional note 13) 13. The method according to any one of claims 1 to 12, wherein during manufacture, the gas inlet port is located at one end of the sealing member, and the internal chamber is formed by flowing the gas from the gas inlet port, through the polymer, and along the cavity in both directions. (Additional note 14) 14. The method according to any one of claims 1 to 13, wherein the polymer is moved along the cavity having a shape of a closed loop in a direction opposite to the polymer injection port and / or the gas introduction port, whereby the polymer has two branches advancing along the cavity. (Additional note 15) 15. The method according to any one of claims 1 to 14, wherein the sealing member has a solid portion that is a portion without an internal chamber, and the solid portion is disposed at an end of the cavity opposite the gas introduction port. (Additional note 16) A sealing member for a respiratory interface device, manufactured by the method according to any one of claims 1 to 15. (Additional note 17) 17. The sealing member of claim 16, wherein the sealing member comprises an internal chamber at least partially surrounded by an elastically deformable surrounding wall, the surrounding wall including a patient contacting surface having a shape that provides an anatomical fit with a patient, and the sealing member includes an opening in fluid communication with the internal chamber of the sealing member and with ambient air, whereby ambient air can pass through and exit the internal chamber in use. (Additional note 18) 18. The sealing member of claim 16 or 17, wherein the sealing member is for a respiratory mask, and the patient contacting surface generally coincides with the frontal plane of the patient in use but circumferentially includes a convex surface in a cheek region of the patient contacting surface, and / or a concave surface in a nose region and / or a chin region of the patient contacting surface. (Additional note 19) 19. The sealing member of claim 17 or 18, wherein an opening is provided in the surrounding wall of the sealing member, the opening being in fluid communication with the internal chamber of the sealing member and with ambient air, thereby allowing ambient air to enter and exit the internal chamber in use. (Additional note 20) 20. The sealing member of claim 19, wherein the opening includes a valve for regulating the flow of ambient air into and out of the internal chamber of the sealing member, the valve being opened by the flow of air into and out of the internal chamber of the sealing member. (Additional note 21) 21. The sealing member of any one of claims 15 to 20, wherein the sealing member has one or more solid portions without an internal chamber, whereby the internal chamber has a first end and a second end separated by the one or more solid portions of the sealing member. (Additional note 22) 22. The sealing member of claim 21, wherein the one or more solid portions of the sealing member separating the first end and the second end of the internal chamber comprise a single, continuous solid portion. (Additional note 23) 23. The sealing member of any one of claims 15 to 22, wherein the sealing member is for a respiratory mask and the one or more solid portions provide greater resistance to deformation in one or more selected regions of the sealing member including a chin region. (Additional note 24) 23. The sealing member according to any one of appended claims 15 to 22, wherein the sealing member is for a laryngeal mask airway, and the one or more solid portions are capable of providing greater deformation resistance to a distal region of a sealing cuff of the laryngeal mask airway. (Additional note 25) A method for producing a respiratory interface device, comprising a method for producing a sealing member for the respiratory interface device according to any one of appended claims 1 to 15. (Additional note 26) 1. A method of manufacturing a respiratory interface device, comprising: (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 a first polymer into the first cavity of the mold through the first polymer injection port to form a body portion of the respiratory interface device; (c) injecting a second polymer into the second cavities of the one or more molds through the second polymer injection port and introducing a gas into the second cavities of the one or more molds through the gas introduction port to form a sealing member of the respiratory interface device, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient-contacting surface determined by the second cavities of the one or more molds and having a shape that provides an anatomical fit with a patient; Including, A method in which the body portion and the sealing member of the respiratory interface device can be formed in any order, whereby one of the body portion or the sealing member is an earlier formed portion and the other of the body portion and the sealing member is a later formed portion, and during injection molding of the later formed portion, the later formed portion engages with the earlier formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together. (Additional note 27) The method according to claim 26, comprising a method for producing a sealing member for the respiratory interface device according to any one of claims 1 to 15. (Additional note 28) The method according to claim 26 or 27, wherein the main body portion of the respiratory interface device is a part that is formed first and the sealing member of the respiratory interface device is a part that is formed later. (Additional note 29) 29. The method of any one of claims 26 to 28, wherein the one or more moulds are configured to allow a later-formed portion of the respiratory interface device to be positioned adjacent to or within either the first cavity or the second cavity forming the later-formed portion of the respiratory interface device, such that during injection moulding of the later-formed portion, the later-formed portion can be engaged with the earlier-formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together. (Additional note 30) 30. The method of claim 29, wherein the later-forming portion is contacted with the earlier-forming portion during injection molding of the later-forming portion. (Additional note 31) The one or more molds include a mold having a first shot configuration defining the first cavity and the first polymer injection port, and a second shot configuration defining the second cavity, the second polymer injection port, and the gas introduction port opening into the second cavity, whereby in the first shot configuration, the first polymer is injected through the first polymer injection port into the first cavity of the mold to form the body portion of the respiratory interface device, and in the second shot configuration, the first polymer is injected through the first polymer injection port into the first cavity of the mold to form the body portion of the respiratory interface device. the second polymer is injected into the second cavity of the mold via the second polymer injection port; and the gas is introduced into the second cavity of the mold via the gas introduction port to form the sealing member of the respiratory interface device. The method of any one of claims 26 to 30, further comprising: disposing the body portion of a respiratory interface device adjacent to the second cavity; injecting the second polymer into the second cavity of the mold via the second polymer injection port; and engaging the sealing member with the body portion in a manner that fixes the body portion and the sealing member of the respiratory interface device together during injection molding of the sealing portion. (Additional note 32) The one or more molds include a first mold having the first cavity and the first polymer injection port, and a second mold having the second cavity, the second polymer injection port, and the gas introduction port opening into the second cavity, whereby the first polymer is injected into the first cavity of the first mold through the first polymer injection port to form the body portion of the respiratory interface device, and then the body portion of the respiratory interface device is disposed within or adjacent to the second cavity. The method according to any one of appended claims 26 to 30, further comprising transferring the body portion of the respiratory interface device to the second mold, injecting the second polymer into the second cavity of the second mold through the second polymer injection port, introducing the gas into the second cavity of the second mold through the gas introduction port to form the sealing member of the respiratory interface device, and engaging the sealing member with the body portion in a manner that fixes the body portion and the sealing member of the respiratory interface device together during injection molding of the sealing portion. (Additional note 33) 33. The method of any one of claims 26 to 32, wherein the second polymer contacts a boundary region of the body portion of the respiratory interface device. (Additional note 34) 34. The method of any one of claims 26 to 33, wherein during manufacture, an opening to the internal chamber is formed around the gas inlet port, the opening allowing ambient air to enter and exit the internal chamber during use. (Additional note 35) 35. The method of claim 34, wherein the opening is formed in the elastically deformable enclosure wall formed from the second polymer. (Additional note 36) 35. The method of claim 34, wherein the interior 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 interior chamber is formed in the wall. (Additional note 37) The method according to any one of appended claims 34 to 36, wherein the gas introduction port protrudes relative to an inner peripheral surface of the mold that defines 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 surrounding wall of the sealing member of the respiratory interface device. (Additional note 38) 38. The method according to any one of claims 34 to 37, wherein the gas introduction port penetrates the body of the respiratory mask and protrudes into the second cavity. (Additional note 39) A respiratory interface device manufactured by the method according to any one of claims 25 to 38. (Additional note 40) A respiratory interface device comprising the sealing member according to any one of claims 16 to 24. (Additional note 41) A respiratory interface device according to claim 40, manufactured by a method according to any one of claims 25 to 38. (Additional note 42) A breathing circuit comprising a source of breathing gas, a patient interface device according to any one of claims 39 to 41, and a breathing tube extending between the source of breathing gas and the patient interface device.

Claims

1. 1. A respiratory interface device comprising: a respiratory interface device body portion formed from a first polymer; and a respiratory interface device sealing member formed from a second polymer, the respiratory interface device sealing member secured to the respiratory interface device body portion, the respiratory interface device sealing member including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed from the second polymer, the enclosure wall including a patient-contacting surface, the respiratory interface device including an opening in a wall of the respiratory interface device body portion, the opening being in fluid communication with the interior chamber of the respiratory interface device sealing member to allow ambient air to pass through and exit the interior chamber in 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, the first layer being bonded to the second layer, and the opening to the internal chamber being formed in the wall.

2. 10. The respiratory interface device of claim 1 which is a respiratory mask.

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

4. The respiratory interface device of claim 1 , wherein the opening is free of a valve having a closed configuration.

5. The respiratory interface device of claim 1 , wherein the sealing member has one or more solid portions that are devoid of an internal chamber.

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

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

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

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

10. 8. A respiratory interface device according to any one of claims 5 to 7, wherein the sealing member is for a laryngeal mask airway, and the one or more solid portions provide greater resistance to deformation in a distal region of a sealing cuff of the laryngeal mask airway.

11. A method for manufacturing a respiratory interface device according to any one of claims 1 to 10, comprising the steps of: (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 said second cavity; (b) injecting a first polymer into the first cavity of the mold through the first polymer injection port to form a body portion of the respiratory interface device; (c) injecting a second polymer into the second cavities of the one or more molds through the second polymer injection port and introducing a gas into the second cavities of the one or more molds through the gas introduction port to form a sealing member of the respiratory interface device, the sealing member of the respiratory interface device including an interior chamber at least partially surrounded by an elastically deformable enclosure wall formed of the second polymer, the enclosure wall including a patient-contacting surface; Including, the body portion and the sealing member of the respiratory interface device may be formed in any order, whereby one of the body portion or the sealing member is an earlier formed portion and the other of the body portion and the sealing member is a later formed portion, and during injection molding of the later formed portion, the later formed portion engages with the earlier formed portion in a manner that secures the body portion and the sealing member of the respiratory interface device together; the gas introduction port protrudes relative to an inner peripheral surface of a mold defining the first cavity or the second cavity, thereby forming an opening in the body portion of the respiratory interface device and / or the surrounding wall of the sealing member of the respiratory interface device, the opening being in fluid communication with the internal chamber of the sealing member of the respiratory interface device; the interior 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, the first layer bonded to the second layer, and the opening to the interior chamber is formed in the wall.

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