Medical components with thermoplastic moldings bonded to substrates

Abstract

To provide a molding member having a robust substrate-molding material interface capable of preventing or delaying the peeling of a molding material from a substrate in a high humidity and / or high temperature environment.SOLUTION: A molded member (10) containing a thermoplastic material and a substrate (11), wherein at least a portion of the substrate is coupled to the thermoplastic material via a silicon-containing linker (14), and a respiratory apparatus containing the molded member are disclosed. A respiratory apparatus containing a molded member, wherein the molded member contains a thermosetting material and a substrate, and wherein at least a portion of the substrate is coupled to the thermosetting material via a silicon-containing linker is also disclosed.SELECTED DRAWING: Figure 1B

Description

REFERENCE TO RELATED APPLICATIONS

[0001] Incorporation by reference to any priority application This application claims priority to U.S. Provisional Patent Application No. 62 / 669,321, filed May 9, 2018, the entire contents of which are incorporated herein by reference. Any and all applications for which a foreign or domestic priority claim is identified in an Application Data Sheet filed with this application are incorporated herein by reference under 37 CFR 1.57. [Technical field]

[0002] The present disclosure relates generally to components suitable for medical applications, and more particularly to components suitable for providing humidified gas to and / or removing humidified gas from a patient. [Background technology]

[0003] In a medical circuit, various components naturally or artificially transport humidified gases to and from a patient. For example, a breathing system may include a breathing device that may humidify and heat gas passing through the breathing device to improve the patient's comfort and / or improve the patient's prognosis of a respiratory disease. Some breathing devices may include a water reservoir and a heating element that heats the water in the reservoir. As the temperature of the water increases, water vapor is formed, which may join the flow of gas passing through the breathing device. Some breathing devices may include a liquid flow controller that provides a controlled flow of liquid, and a heating system that includes a heating surface located in the gas passage and configured to humidify the gas passing through the passage. Summary of the Invention [Means for solving the problem]

[0004] Some embodiments provide molding members with a robust substrate-molding material interface that can prevent or retard delamination of the molding material from the substrate in high humidity and / or high temperature environments.

[0005] Some embodiments disclosed herein relate to a humidification device (e.g., for respiratory humidification, insufflation, etc.). In some embodiments, the humidification device comprises a gas flow path. The gas flow path can have an interior region and an inlet configured to receive gas into the interior region. The gas flow path can have an outlet configured to allow passage of gas from the interior region of the gas flow path. In some embodiments, the device comprises a heater having a heating surface. The heater can be disposed between the inlet and the outlet of the gas flow path. In some implementations, the heater is configured to heat the received humidification liquid by the heating surface to humidify the gas flowing through the gas flow path. In some embodiments, the heater comprises a printed circuit board (PCB). The PCB can have a heating track. The PCB can have at least one electrical contact. In some embodiments, the electrical contact is configured to receive and / or transmit an electrical signal (e.g., from a power source, etc.). In some embodiments, the electrical contact is configured to receive electricity from a power source (e.g., through electrical conductors connected to the electrical contact) and provide power to the PCB. In some embodiments, the electrical contact is in electrical communication with the heating track. In some implementations, the heater comprises a molding material disposed over at least a portion of the PCB. The molding material and the portion of the PCB can be adhered by a bonding layer comprising a silicon-containing linker. In some embodiments, the bonding layer couples at least a portion of the molding material to the PCB. In some implementations, the respiratory apparatus is configured to provide humidified gas to a patient.

[0006] In some embodiments, the PCB can span a portion of the gas flow path from an interior region to a region external to the gas flow path. A portion of the PCB can be exposed at the exterior region of the gas flow path, and a different portion of the PCB can be in thermal communication with the interior region of the gas flow path. In some embodiments, the PCB is in thermal communication with the gas flow path. For example, in some embodiments, the PCB can receive temperature information from the gas flow path (e.g., from gas in the gas flow chamber), transfer thermal energy to the gas flow path (e.g., to heat the gas in the gas flow path), or do both.

[0007] In some implementations, the PCB comprises one or more electrical components configured to receive, transmit and / or process information regarding the condition of the internal region of the respiratory apparatus. For example, in some embodiments, the PCB can receive, transmit and / or process information regarding one or more gases in the apparatus (e.g., temperature, pressure and humidity data). In some implementations, the PCB comprises one or more electrical components configured to receive, transmit and / or process information regarding the condition of the internal region of the gas flow path. The PCB can comprise one or more sensors. In some embodiments, the PCB can comprise one or more temperature sensors in thermal communication with the internal region of the gas flow path. The PCB can comprise two or more temperature sensors, at least one of the temperature sensors configured to measure a temperature of the heated surface. The PCB can comprise two or more temperature sensors, at least one of the temperature sensors configured to measure a surface temperature of the molding material. In some embodiments, the PCB comprises a temperature sensor configured to detect whether the heated surface is wetted by the humidification liquid in at least one region. The one or more temperature sensors can be located on, on, adjacent to or in close proximity to the heated surface. The one or more temperature sensors may be located in, on, adjacent to or proximate to the molding material. In some embodiments, the PCB comprises one or more of a pressure sensor, a flow sensor, a humidity sensor and / or a fluid level sensor.

[0008] In some embodiments, the heating track of the PCB is in thermal communication with the interior region of the gas flow path. The heating track of the PCB can be covered by the molding material and simultaneously in thermal communication with the interior region of the gas flow path through the molding material. For example, the heating surface can include a portion of the molding material covering the heating track. In other embodiments, the heating surface includes the heating track, and the heating track (or a portion thereof) is directly exposed to the interior region of the gas flow path.

[0009] In some embodiments, the molding material covers one or more of the electrical components and / or sensors of the PCB. The molding material can isolate one or more of the electrical components and / or sensors from direct contact with an interior region of the gas flow passage (e.g., through the molding material). The molding material can be configured to enable monitoring of the interior region of the gas flow passage (e.g., temperature, pressure, humidity, relative proportions of different gases therein if more than one is present, etc.) by the electrical components and / or sensors of the PCB through the molding material.

[0010] In some embodiments, the humidification device comprises a humidification liquid inlet for supplying humidification liquid from a reservoir to the heater. In some embodiments, the humidification device comprises a humidification liquid inlet for delivering humidification liquid from a reservoir to a heating surface of the heater. In some embodiments, the inlet is configured to drip humidification liquid (e.g., water) onto the heating surface. In some embodiments, the inlet is configured to supply humidification liquid onto a surface of the device (e.g., a wall, a groove, a slope, etc. of the device) that directs the humidification liquid to the heating surface. In some embodiments, the humidification device comprises a humidification liquid pre-heater. In some embodiments, the respiratory humidification device comprises a humidification liquid flow controller. In some embodiments, the liquid flow controller comprises a metering system and / or a pump. In some embodiments, the humidification device comprises a gas pre-heater.

[0011] In some implementations, the molding material comprises a thermoplastic material and / or a thermoset material. In some implementations, the molding material comprises a thermoplastic material. In some implementations, the molding material comprises a thermoset material. In some embodiments, the molding material comprises an injection molded thermoplastic material. In some embodiments, the molding material comprises an overmolded thermoplastic material. In some embodiments, the heater is formed by overmolding a thermoplastic material around the PCB. In some embodiments, the heater is formed by injection molding a thermoplastic material around the PCB. In some embodiments, the heater is formed by insert molding a thermoplastic material around the PCB. In some embodiments, the thermoplastic material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene, crosslinkable polyolefin, and combinations thereof. In some embodiments, the molding material comprises a thermosetting material. In some embodiments, the thermosetting material comprises one or more of silicone rubber, epoxy, and polyurethane.

[0012] In some embodiments, the molding material encapsulates at least a portion of the PCB. In some embodiments, the portion of the PCB encapsulated by the molding material includes a portion of the heating track. In some embodiments, the PCB is encapsulated such that it is not exposed to the interior region of the gas flow path. In some embodiments, the molding material physically isolates the PCB from the interior region of the gas flow path while allowing the PCB to collect and / or distribute information about the interior region of the gas flow path (such as the temperature, humidity, flow rate of the gas, etc.). In some embodiments, the encapsulated PCB has portions that are not covered by the molding material (e.g., portions of the PCB that are external to the gas flow path), thereby allowing contact with the PCB (e.g., with electrical wires / conduits, etc.). In some embodiments, the molding material provides a barrier between the PCB and the gas flow path. In some embodiments, the molding material completely isolates the PCB from the interior region of the gas flow path. In some embodiments, at least one electrical contact of the PCB is not encapsulated and / or covered by the molding material.

[0013] In some embodiments, a portion of the molding material comprises microchannels and / or surface structures. In some embodiments, the microchannels and / or surface structures are configured to receive, distribute, and / or hold humidifying liquid, such that the humidifying liquid can be heated by a heating track. In some embodiments, a portion of the molding material is configured to receive and hold humidifying liquid, such that the humidifying liquid can be heated by a heating track. In some embodiments, the portion of the molding material configured to receive humidifying liquid is coupled to the PCB by a bonding layer. In some embodiments, the molding material is hydrophilic or hydrophobic.

[0014] In some embodiments, the bonding layer chemically couples the molding material to a portion of the PCB (e.g., a portion of a substrate that is a portion of the PCB). In some embodiments, the bonding layer chemically couples the thermoplastic resin to a portion of the heater. In some embodiments, the bonding layer comprises one or more of covalent bonds, hydrogen bonds, van der Waals forces, and / or ionic bonds that link the molding material to a portion of the PCB. In some embodiments, the bonding layer comprises covalent bonds between substituents on the molding material and substituents on the PCB. In some embodiments, the bonding layer is formed, at least in part, through reaction of one or more of epoxy ring, amine, succinic anhydride, methoxyl, and / or ethoxyl moieties with one or more of carboxyl, amine, epoxy ring, succinic anhydride, and / or reactive silanol moieties. In some embodiments, the bonding layer is formed, at least in part, through reaction between succinic anhydride moieties and amine moieties. In some embodiments, the bonding layer is formed, at least in part, through reaction between succinic anhydride moieties and secondary amine moieties.

[0015] In some embodiments, the silicon-containing linker is [ka] or a polymerized silane coupling linker thereof; ** is the point of attachment to the molding material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is the attachment point to the PCB, and at least one of R' is -O- * Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; -L- ** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] is selected from the group consisting of:

[0016] In some embodiments, the silicon-containing linker is [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxyl, —O— * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- ** and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0017] In some embodiments, the silicon-containing linker is [ka] and polymerized siloxane linkers thereof, wherein each Z is independently hydroxy or -O- * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material;-L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L-″ **and -L-'' ** teeth, [ka] is selected from the group consisting of ** is a bond point to the thermoplastic material; at least one of Z is -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''- ** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than 1; and n is an integer greater than 1.

[0018] In some embodiments, the humidification liquid comprises water.

[0019] Some embodiments relate to a respiratory system. In some embodiments, the respiratory system comprises a gas (e.g., air, oxygen, etc.) flow source. In some embodiments, the respiratory system comprises a humidification device as disclosed above or elsewhere herein. In some embodiments, the respiratory system comprises an inspiratory tube. In some embodiments, the respiratory system comprises a patient interface. In some embodiments, the gas flow source is configured to provide high flow therapy. In some embodiments, the system provides a flow rate in the range of about 2 L / min to about 150 L / min, or other flow rates as disclosed elsewhere herein.

[0020] Some embodiments relate to a component for use in a respiratory system or a medical air delivery system. In some embodiments, the component includes an electronic component including conductive tracks and a substrate, the conductive tracks being located on the substrate. In some embodiments, the component includes a molding material molded onto at least a portion of the electronic component. In some embodiments, the component includes a bonding layer that couples the molding material to at least a portion of the electronic component. In some embodiments, the bonding layer includes a silicon-containing linker.

[0021] In some embodiments, the bonding layer is a separate layer from the molding material and the electronic component. In some embodiments, the bonding layer includes pendant groups that are covalently bonded to the molding material and matching pendant groups that are covalently bonded to the electronic component. In some embodiments, the pendant groups from the substrate (e.g., the electronic component) may or may not be covalently bonded to the pendant groups of the molding material. In some embodiments, the bonding layer chemically couples the molding material to the portion of the electronic component. In some embodiments, the bonding layer includes one or more of covalent bonds, hydrogen bonds, van der Waals forces, and / or ionic bonds that link the molding material to the portion of the electronic component. In some embodiments, the bonding layer physically couples the molding material to the substrate (e.g., the electronic component).

[0022] In some embodiments, the tie layer is formed through a reaction of one or more of an epoxy ring, an amine, a succinic anhydride, a methoxyl, or an ethoxyl moiety with one or more of a carboxyl, an amine, an epoxy ring, a succinic anhydride, or a reactive silanol moiety. In some embodiments, the tie layer is formed through a reaction between a succinic anhydride moiety and an amine moiety. In some embodiments, the succinic anhydride moiety is provided by the electronic component and the amine moiety is provided by the molding material. In some embodiments, the electronic component and the succinic anhydride moiety are provided by the molding material. In some embodiments, the tie layer is formed through a reaction between a succinic anhydride moiety and a secondary amine moiety. In some embodiments, the succinic anhydride moiety is provided by the electronic component and the secondary amine moiety is provided by the molding material. In some embodiments, the secondary amine moiety is provided by the electronic component and the succinic anhydride moiety is provided by the molding material.

[0023] In some embodiments, the silicon-containing linker is [ka] or a polymerized silane coupling linker thereof; ** is the point of attachment to the molding material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is the attachment point to the PCB, and at least one of R' is -O- * Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N, -L- ** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] is selected from the group consisting of:

[0024] In some embodiments, the silicon-containing linker is [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, —O— * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- ** and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0025] In some embodiments, the silicon-containing linker is [ka] and polymerized siloxane linkers thereof, wherein each Z is independently hydroxy or -O- * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material, -L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L″- ** and -L''- ** teeth, [ka] is selected from the group consisting of ** is a bond point to the thermoplastic material; at least one of Z is -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''- ** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than 1; and n is an integer greater than 1.

[0026] In some embodiments, the electronic component is a printed circuit board (PCB). In some embodiments, the PCB is rigid or flexible.

[0027] In some embodiments, the electronic component comprises silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink, or combinations thereof.

[0028] In some embodiments, the portion of the electronic component on which the molding material is applied is exposed to heat and moisture in the breathing system.

[0029] In some embodiments, the molding material comprises a thermoplastic material or a thermosetting material. In some embodiments, a thermoplastic material is used. In some embodiments, the thermoplastic material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene, crosslinkable polyolefin, and combinations thereof. In some embodiments, the thermoplastic material comprises an overmolded thermoplastic material. In some embodiments, the component is formed by injection molding a thermoplastic material around an electronic component. In some embodiments, the component is formed by overmolding a thermoplastic material around an electronic component. In some embodiments, the component is formed by insert molding a thermoplastic material around an electronic component. In some embodiments, a thermosetting material is used. In some embodiments, the molding material comprises a thermosetting polymer. In some embodiments, the thermosetting material comprises one or more of a silicone rubber, an epoxy, and a polyurethane.

[0030] In some embodiments, the molding material comprises microchannels and / or surface features on a surface. In some embodiments, the microchannels and / or surface features are configured to receive, distribute, and / or retain humidification liquid. In some embodiments, the molding material is hydrophilic or hydrophobic.

[0031] In some embodiments, the electronic component comprises one or more sensors. In some embodiments, the one or more sensors include one or more of a temperature sensor, a pressure sensor, a flow sensor, a humidity sensor, and / or a fluid level sensor. In some embodiments, the one or more sensors include one or more of a temperature sensor, a pressure sensor, a flow sensor, and / or a humidity sensor, where the one or more of the pressure sensor, the flow sensor, and / or the humidity sensor are configured to detect a parameter of the gas in the gas flow path. In some embodiments, the PCB comprises a fluid level sensor and / or a liquid sensor. In some embodiments, the molding material covers the sensor.

[0032] In some embodiments, the component is part of a breathing system further comprising one or more of a housing for a filter, a gas conduit, a chamber, an inlet tube, a tube connector, a tube fitting, a tube elbow, a heating element, a water injection component, and / or a patient interface component. In some embodiments, the electronic component comprises electrical contacts. In some embodiments, the component, when in use, is exposed to a higher temperature and / or humidity in the gas flow path relative to the surrounding environment. In some embodiments, the component further comprises a humidification chamber.

[0033] Some embodiments relate to a respiratory or medical air insufflation device comprising the above-mentioned components. In some embodiments, the respiratory or medical air insufflation device further comprises a humidification chamber.

[0034] Some embodiments relate to a heater for a humidification chamber. In some embodiments, the heater comprises a heating component comprising a heating track and a substrate, the heating track being disposed on the substrate. In some embodiments, the heater comprises a molding material disposed on at least a portion of the heating component. In some embodiments, the heater comprises a bonding layer that couples at least a portion of the molding material to the heating component. In some embodiments, the heater comprises a bonding layer that couples the molding material to the heating component where the molding material is disposed on the heating component. In some embodiments, the bonding layer comprises a silicon-containing linker.

[0035] In some embodiments, the bonding layer is a separate layer from the molding material and the heating component. In some embodiments, the bonding layer includes pendant groups covalently bonded to the molding material and matching pendant groups covalently bonded to the electronic component. In some embodiments, the bonding layer chemically couples the molding material to the portion of the electronic component. In some embodiments, the bonding layer includes one or more of covalent bonds, hydrogen bonds, van der Waals forces, and / or ionic bonds that link the molding material to the portion of the electronic component. In some embodiments, the bonding layer is formed through a reaction between one or more of an epoxy ring, an amine, a succinic anhydride, a methoxyl, or an ethoxyl moiety and one or more of a carboxyl, an amine, an epoxy ring, a succinic anhydride, or a reactive silanol moiety. In some embodiments, the bonding layer is formed at least in part through a reaction between a succinic anhydride moiety and an amine moiety. In some embodiments, the bonding layer is formed at least in part through a reaction between a succinic anhydride moiety and a secondary amine moiety.

[0036] In some embodiments, the silicon-containing linker is [ka] or a polymerized silane coupling linker thereof; ** is the point of attachment to the molding material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is the attachment point to the PCB, and at least one of R' is -O- * Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; -L- ** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] is selected from the group consisting of:

[0037] In some embodiments, the silicon-containing linker is [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, —O— * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- ** and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0038] In some embodiments, the silicon-containing linker is [ka] and polymerized siloxane linkers thereof, wherein each Z is independently selected from the group consisting of hydroxyl or -O- * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material;-L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L″- ** and -L''- ** teeth, [ka] is selected from the group consisting of ** is a bond point to the thermoplastic material; at least one of Z is -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''- ** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than 1; and n is an integer greater than 1.

[0039] In some embodiments, the heating component is a printed circuit board (PCB). In some embodiments, the PCB is rigid or flexible. In some embodiments, the substrate comprises silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, or combinations thereof. In some embodiments, the molding material comprises a thermoplastic material or a thermoset material. In some embodiments, the molding material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene, crosslinkable polyolefin, and combinations thereof. In some embodiments, the thermoplastic material comprises an injection molded thermoplastic material (e.g., an overmolded thermoplastic material, an insert molded thermoplastic material, etc.). In some embodiments, the heater is formed by injection molding a thermoplastic material around a heating component. In some embodiments, the heater is formed by overmolding a thermoplastic material around the heating component. In some embodiments, the heater is formed by insert molding a thermoplastic material around the heating component. In some embodiments, the thermoset material includes one or more of silicone rubber, epoxy, and polyurethane.

[0040] In some embodiments, the molding material comprises microchannels and / or surface features. In some embodiments, the microchannels or surface features are configured to retain humidifying liquid. In some embodiments, the molding material is hydrophilic or hydrophobic.

[0041] In some embodiments, the heating track is configured to heat the humidification liquid when in thermal communication with the heating component, causing the humidification liquid to vaporize into the gas flow path, hi some embodiments, the heating component comprises an electrical connector.

[0042] Some embodiments relate to a heater for a humidification chamber. In some embodiments, the heater comprises a heating component comprising a heating track disposed on a substrate. In some embodiments, the heater comprises a molding material encapsulating the heating component, the heating component being separated from an interior region of the humidification chamber by the molding material. In some embodiments, the heater comprises a bonding layer coupling the molding material to the heating component.

[0043] In some embodiments, the bonding layer is a separate layer from the molding material and the heating component. In some embodiments, the bonding layer includes a pendant group that is covalently bonded to the molding material and a corresponding pendant group that is covalently bonded to the electronic component. In some embodiments, the bonding layer includes a silicon-containing linker layer. In some embodiments, the bonding layer chemically couples the molding material to the electronic component. In some embodiments, the bonding layer includes one or more of covalent bonds, hydrogen bonds, van der Waals forces, and / or ionic bonds that link the molding material and the portions of the heating component. In some embodiments, the bonding layer is formed at least in part through a reaction between one or more of an epoxy ring, an amine, a succinic anhydride, a methoxyl, or an ethoxyl moiety and one or more of a carboxyl, an amine, an epoxy ring, a succinic anhydride, or a reactive silanol moiety. The epoxy reacts at least with the amine or the carboxyl. The succinic anhydride reacts at least with the amine. The amine reacts at least with the carboxyl, the epoxy ring, and the succinic anhydride. The ethoxyls and methoxyls react with the silanols. In some embodiments, the tie layer is formed at least in part through a reaction between succinic anhydride moieties and amine moieties. In some embodiments, the tie layer is formed at least in part through a reaction between succinic anhydride moieties and secondary amine moieties.

[0044] In some embodiments, the silicon-containing linker is [ka] or a polymerized silane coupling linker thereof; ** is the point of attachment to the molding material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is the attachment point to the PCB, and at least one of R' is -O- * Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; -L- ** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] is selected from the group consisting of:

[0045] In some embodiments, the silicon-containing linker is [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, —O— * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- **and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0046] In some embodiments, the silicon-containing linker is [ka] and polymerized siloxane linkers thereof, wherein each Z is independently hydroxy or -O- * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material;-L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L″- ** and -L''- ** teeth, [ka] is selected from the group consisting of ** is a bond point to the thermoplastic material; at least one of Z is -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''- ** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, **is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than 1; and n is an integer greater than 1.

[0047] In some embodiments, the heating component comprises a printed circuit board (PCB). In some embodiments, the PCB and / or the substrate of the PCB is rigid or flexible. In some embodiments, the PCB and / or the substrate of the PCB comprises silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink, or combinations thereof.

[0048] In some embodiments, the molding material comprises a thermoplastic material or a thermosetting material. In some embodiments, the thermoplastic material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene, crosslinkable polyolefin, and combinations thereof.

[0049] In some embodiments, the heater is formed by injection molding a thermoplastic material around the heating component. In some embodiments, the heater is formed by overmolding a thermoplastic material around the heating component. In some embodiments, the heater is formed by insert molding a thermoplastic material around the heating component. In some embodiments, the thermoset material comprises one or more of silicone rubber, epoxy, and polyurethane. In some embodiments, the molding material comprises microchannels and / or surface features. In some embodiments, the microchannels or surface features are configured to retain a humidifying liquid. In some embodiments, the molding material is hydrophilic or hydrophobic.

[0050] In some embodiments, the heating track is configured to heat the humidification liquid when in thermal communication with the heating component, causing the humidification liquid to vaporize into the gas flow path, hi some embodiments, the heating component comprises an electrical connector.

[0051] Some embodiments relate to a humidification chamber comprising an inlet for receiving gas from a gas source and an outlet for delivering gas to a patient, the inlet and outlet defining a gas flow path. In some embodiments, the humidification chamber includes a heater as disclosed above or elsewhere herein. In some embodiments, the heater is configured to heat and humidify the gas while in the gas flow path. In some embodiments, the chamber is configured for use in a breathing system or a medical air delivery system.

[0052] Some embodiments relate to a molded member. In some embodiments, the molded member comprises a thermoplastic material and a substrate. In some embodiments, at least a portion of the substrate is coupled to the thermoplastic material via a silicon-containing linker. In some embodiments, the silicon-containing linker is formed at least in part through a reaction between a succinic anhydride moiety and an amine moiety.

[0053] Some embodiments relate to a method of coupling a thermoplastic material to a substrate. In some embodiments, the method includes providing a substrate having at least one silicon-containing linking agent attached to a surface. In some embodiments, the method includes contacting a thermoplastic material with the attached silicon-containing linking agent to form a bond between the thermoplastic material and the substrate. In some embodiments, the bond includes a reaction product from a reaction between a succinic anhydride moiety and an amine moiety. In some embodiments, the succinic anhydride moiety is provided on a silicon-containing linker. In some embodiments, the amine moiety is provided on a thermoplastic resin. In some embodiments, the amine moiety is provided on a silicon-containing linker. In some embodiments, the succinic anhydride moiety is provided on a thermoplastic resin. In some embodiments, the amine moiety includes a secondary amine moiety. In some embodiments, providing a substrate having at least one silicon-containing linking agent attached to a surface includes providing a substrate comprising hydroxyls and / or carboxyls on a surface and reacting the silicon-containing linking agent with the hydroxyls and / or carboxyls on the surface of the substrate. In some embodiments, reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate comprises hydrolyzing the silicon-containing linking agent to form reactive silanols and contacting the reactive silanols with hydroxyls and / or carboxyls on the substrate. In some embodiments, reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate comprises plasma enhanced chemical vapor deposition (PECVD). In some embodiments, providing a substrate comprising hydroxyls and / or carboxyls on a surface further comprises activating the substrate surface by plasma treatment, corona discharge, ozone treatment, chemical treatment, or flame treatment.

[0054] In some embodiments, the silicon-containing linking agent is a silane coupling agent. In some embodiments, the silane coupling agent has the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2 and R3 in (A1) or at least one of R1, R2, R3, R4, R5 and R6 in (A2) is hydroxyl or C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; and X is selected from the group consisting of primary and secondary amines and succinic anhydride.

[0055] In some embodiments, the silane coupling agent is selected from the group consisting of 3-aminopropyltrimethoxysilane (APTMS), 3-aminopropyltriethoxysilane (APTES), (3-triethoxysilyl)propylsuccinic anhydride (TEPSA) and bis(3-trimethoxysilylpropyl)amine. In some embodiments, the silicon-containing linking agent is a siloxane.

[0056] In some embodiments, the silane coupling agent has the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2, R3, R4 and R5 in (A5), at least one of R1, R2, R3, R4, R5 and R6 in (A6) and (A7), and at least two of R1 and R2 in (A8) are independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; X is selected from the group consisting of primary amines, secondary amines, and succinic anhydride; m is an integer of 1 or greater; and n is an integer of 1 or greater.

[0057] In some embodiments, the siloxane is selected from the group consisting of aminopropyl silsesquioxane, aminoethyl aminopropyl silsesquioxane, aminopropyl silsesquioxane-methyl silsequioxane, and non-functional siloxane.

[0058] In some embodiments, the substrate is part of (e.g., forms part of) a printed circuit board (PCB). In some embodiments, the PCB is rigid. In some embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0059] Some embodiments relate to a respiratory device comprising a molding member comprising a thermosetting material and a substrate. In some embodiments, at least a portion of the substrate is coupled to the thermosetting material via a silicon-containing linker. In some embodiments, the silicon-containing linker has the following formula: [ka] or a polymerized silicon-containing linker thereof; ** is the point of attachment to the thermosetting material; each R' is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, or -O- * and * is a point of attachment to the substrate, and at least one of R' is -O- * and;-L'- ** teeth [ka] where R is H or C1-C8 alkyl; [ka] teeth [ka] and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0060] In some embodiments, the thermosetting material includes -Si-H moieties. In some embodiments, the thermosetting material is silicone rubber. In some embodiments, the molded member is a housing for a filter, a gas conduit, a chamber, an intake tube, a tube connector, a tube fitting, a tube elbow, a heating element, or a patient interface component. In some embodiments, the thermosetting material is a molding material on a substrate. In some embodiments, the molded member is formed by injection molding the molding material around the substrate. In some embodiments, the molded member is formed by insert molding the molding material around the substrate. In some embodiments, the molded member is formed by overmolding the molding material around the substrate. In some embodiments, the molded material comprises microchannels or structures on a surface.

[0061] In some embodiments, the substrate comprises a material that can be activated to form hydroxyl groups on a surface. In some embodiments, the substrate is silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink, or combinations thereof. In some embodiments, the substrate is part of (or forms part of) a printed circuit board (PCB). In some embodiments, the PCB is rigid. In some embodiments, the PCB is flexible. In some embodiments, the substrate is rigid or flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a pressure sensor, a flow sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0062] Some embodiments relate to a method of bonding a thermosetting material to a substrate. In some embodiments, the method includes providing a substrate having a silicon-containing linking agent attached to a surface thereof. In some embodiments, the method includes reacting a silicone resin with the attached silicon-containing linking agent. In some embodiments, the silicone resin includes -Si-H moieties. In some embodiments, the method further includes curing the silicone resin to form a thermosetting material. In some embodiments, the thermosetting material is a silicone rubber. In some embodiments, the attached silicon-containing linking agent includes vinyl moieties. In some embodiments, reacting the silicone resin with the attached silicon-containing linking agent on the substrate includes reacting -Si-H moieties in the silicone resin with vinyl moieties in the attached silicon-containing linking agent. In some embodiments, providing a substrate having a silicon-containing linking agent attached to a surface thereof further includes providing a substrate including hydroxyls and / or carboxyls on a surface thereof and reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate. In some embodiments, reacting the silicon-containing linking agent with hydroxyl and / or carboxyl on the substrate comprises hydrolyzing the silicon-containing linking agent to form reactive silanols and contacting the reactive silanols with hydroxyl and / or carboxyl on the substrate. In some embodiments, reacting the silicon-containing linking agent with hydroxyl and / or carboxyl on the substrate comprises plasma enhanced chemical vapor deposition (PECVD). In some embodiments, providing a substrate comprising hydroxyl and / or carboxyl on its surface further comprises activating the substrate surface by plasma treatment, corona discharge, ozone treatment, chemical treatment or flame treatment.

[0063] In some embodiments, the silicon-containing linking agent is a vinyl-functionalized silane coupling agent. In some embodiments, the vinyl-functionalized silane coupling agent has the formula: [ka] wherein R1, R2 and R3 in (A9) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least one of R1, R2 and R3 is hydroxyl or C1-C8 alkoxy; R1, R2, R3, R4, R5 and R6 in (A10) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least one of R1, R2, R3, R4, R5 and R6 is hydroxyl or C1-C8 alkoxy; X' is [ka] where R is H or C1-C8 alkyl; -X'- is [ka] and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from N and O.

[0064] In some embodiments, the silicon-containing linking agent is gamma-methacryloxypropyltrimethoxysilane (γ-MPTS), vinyltrimethylsilane (VTMS) (3-acryloxylpropyl)trimethoxysilane, 1,1-bis(trimethoxysilylmethyl)ethylene, 1,2-bis(methyldiethoxysilyl)ethylene, and bis(3-trimethoxysilylpropyl) fumarate.

[0065] In some embodiments, the substrate is ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, or filled polymer. In some embodiments, the substrate is a printed circuit board (PCB). In some embodiments, the PCB is rigid. In some embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0066] One aspect of the present disclosure includes a molding member comprising a thermoplastic material and a substrate, wherein at least a portion of the substrate is coupled to the thermoplastic material via a silicon-containing linker.In some embodiments, the silicon-containing linker is covalently bonded to the thermoplastic material.In some embodiments, the silicon-containing linker is covalently bonded to the substrate.

[0067] In some embodiments, the silicon-containing linker is a silane coupling linker, a silicon alkoxy linker, or a siloxane linker.

[0068] In some embodiments, the silane coupling linker is [ka] or a polymerized silane coupling linker thereof; ** is the point of attachment to the thermoplastic material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is a point of attachment to the substrate, and at least one of R' is -O- * Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N, -L-** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] is selected from the group consisting of:

[0069] In some embodiments, the silicon alkoxy linker is [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxyl, —O— * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- ** and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0070] In some embodiments, the siloxane linker is [ka] and polymerized siloxane linkers thereof; wherein each Z is independently selected from the group consisting of hydroxy or -O- * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material, -L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L″- ** and -L''- ** teeth, [ka] at least one of Z is selected from the group consisting of -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''- ** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than 1; and n is an integer greater than 1.

[0071] In some embodiments, the thermoplastic material comprises an amino, carboxyl, epoxy, succinic anhydride or silane moiety. In some embodiments, the thermoplastic material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene and crosslinkable polyolefin. The molded part is a housing for a filter, a gas conduit, a chamber, an air inlet tube, a tube connector, a tube fitting, a tube elbow, a heating element, an irrigation part or a patient interface part.

[0072] In some embodiments, the thermoplastic material is a molding material on a substrate. In some embodiments, the molding member is formed by injection molding the molding material around the substrate. In some embodiments, the molding member is formed by insert molding the molding material around the substrate. In some embodiments, the molding member is formed by overmolding the molding material around the substrate. In some embodiments, the molding material comprises microchannels or structures on a surface.

[0073] In some embodiments, the thermoplastic material has a Shore hardness greater than about 30. In some embodiments, the thermoplastic material is hydrophilic. In some embodiments, the thermoplastic material is hydrophobic.

[0074] In some embodiments, the substrate comprises a material that can be activated to form hydroxyl groups on a surface. In some embodiments, the substrate is a printed circuit board (PCB). In some embodiments, the PCB is rigid and in other embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of temperature sensors, pressure sensors, flow sensors, humidity sensors, and fluid level sensors. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector. In some embodiments, the substrate is silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink, or combinations thereof.

[0075] One aspect of the present disclosure includes a respiratory apparatus including the molded member described above.

[0076] One aspect of the present disclosure includes a method of coupling a thermoplastic material to a substrate, the method comprising the steps of providing a substrate having at least one silicon-containing linking agent attached to a surface thereof, and bonding a thermoplastic material to the attached silicon-containing linking agent.

[0077] In some embodiments, the thermoplastic material comprises an amino, carboxyl, epoxy, succinic anhydride or silane moiety. In some embodiments, the thermoplastic material is selected from the group consisting of ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene and crosslinkable polyolefin.

[0078] In some embodiments, the attached silicon-containing linking agent comprises a moiety selected from the group consisting of a primary or secondary amine, a succinic anhydride, and an epoxy group.

[0079] In some embodiments, bonding the thermoplastic material to the substrate further comprises reacting an amino or carboxyl group in the thermoplastic material with an epoxy in the attached silicon-containing linking agent. In other embodiments, bonding the thermoplastic material to the substrate further comprises reacting an epoxy, carboxyl or succinic anhydride in the thermoplastic material with an amino in the attached silicon-containing linking agent. In other embodiments, bonding the thermoplastic material to the substrate further comprises reacting an amino in the thermoplastic material with a succinic anhydride in the attached silicon-containing linking agent. In other embodiments, bonding the thermoplastic material to the substrate further comprises hydrolyzing a thermoplastic material that includes a silane moiety to form at least one silanol on the surface and reacting the at least one silanol with a hydroxyl in the attached silicon-containing linking agent.

[0080] In some embodiments, the step of providing a substrate having a silicon-containing linking agent attached thereto comprises providing a substrate comprising hydroxyls and / or carboxyls on a surface thereof and reacting the silicon-containing linking agent with the hydroxyls and / or carboxyls on the surface of the substrate.

[0081] In some embodiments, reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate comprises hydrolyzing the silicon-containing linking agent to form reactive silanols and contacting the reactive silanols with hydroxyls and / or carboxyls on the substrate. In other embodiments, reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate further comprises plasma enhanced chemical vapor deposition (PECVD).

[0082] In some embodiments, the step of providing a substrate comprising hydroxyls and / or carboxyls on a surface further comprises activating the substrate surface by plasma treatment, corona discharge, ozone treatment, chemical treatment, or flame treatment.

[0083] In some embodiments, the silicon-containing linking agent is a silane coupling agent having the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2 and R3 in (A1) or at least one of R1, R2, R3, R4, R5 and R6 in (A2) is hydroxyl or C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; and X is selected from the group consisting of epoxy, primary and secondary amines, and succinic anhydride. In some embodiments, the silane coupling agent is selected from the group consisting of 3-glycidoxypropyltrimethoxysilane (GPTMS), 3-aminopropyltrimethoxysilane (APTMS), 3-aminopropyltriethoxysilane (APTES), (3-triethoxysilyl)propylsuccinic anhydride (TEPSA), and bis(3-trimethoxysilylpropyl)amine.

[0084] In some embodiments, the silicon-containing linking agent is a silicon alkoxide, the silicon alkoxide having the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least two of R1, R2, R3 and R4 in (A3) and at least two of R1, R2, R3, R4, R5 and R6 in (A4) are hydroxyl or C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N. In some embodiments, the silicon alkoxide is selected from the group consisting of tetramethoxysilane (TMOS), tetraethoxysilane (TEOS) and 1,2-bis(triethoxysilyl)ethane.

[0085] In some embodiments, the silicon-containing linking agent is a siloxane and the silane coupling agent has the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2, R3, R4 and R5 in (A5), at least one of R1, R2, R3, R4, R5 and R6 in (A6) and (A7), and at least two of R1 and R2 in (A8) are independently selected from the group consisting of hydroxyl or is C1-C8 alkoxy;Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N;Y' is C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N;X is selected from the group consisting of epoxy, primary or secondary amines, and succinic anhydride;m is an integer equal to or greater than 1;n is an integer equal to or greater than 1. In some embodiments, the siloxane is selected from the group consisting of aminopropyl silsesquioxane, aminoethyl aminopropyl silsesquioxane, aminopropyl silsesquioxane-methyl silsequioxane, and non-functional siloxane.

[0086] In some embodiments, the substrate is ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, or filled polymer. In other embodiments, the substrate is a printed circuit board (PCB). In some embodiments, the PCB is rigid. In other embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0087] One aspect of the present disclosure includes a respiratory device including a molding member, the molding member including a thermosetting material and a substrate, at least a portion of the substrate being coupled to the thermosetting material via a silicon-containing linker.

[0088] In some embodiments, the silicon-containing linker is covalently bonded to the thermosetting material. In some embodiments, the silicon-containing linker is covalently bonded to the substrate. In some embodiments, the silicon-containing linker has the following formula: [ka] or a polymerized silicon-containing linker thereof; ** is the point of attachment to the thermosetting material; each R' is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, or -O- * and * is a point of attachment to the substrate, and at least one of R' is -O- * and;-L'- ** teeth [ka] where R is H or C1-C8 alkyl; [ka] teeth [ka] and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0089] In some embodiments, the thermosetting material includes -Si-H moieties, hi some embodiments, the thermosetting material is a silicone rubber.

[0090] In some embodiments, the molded member is a housing for a filter, a gas conduit, a chamber, an intake tube, a tube connector, a tube fitting, a tube elbow, a heating element, or a patient interface component. In some embodiments, the thermosetting material is a molded material on a substrate.

[0091] In some embodiments, the molding member is formed by injection molding the molding material around the substrate. In some embodiments, the molding member is formed by insert molding the molding material around the substrate. In some embodiments, the molding member is formed by overmolding the molding material around the substrate. In some embodiments, the molding material comprises microchannels or structures on a surface.

[0092] In some embodiments, the substrate comprises a material that can be activated to form hydroxyl groups on a surface. In some embodiments, the substrate is silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink, or combinations thereof. In some embodiments, the substrate is a printed circuit board (PCB). In some embodiments, the PCB is rigid. In other embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0093] One aspect of the present disclosure includes a method of coupling a thermosetting material to a substrate, the method comprising the steps of providing a substrate having a silicon-containing linking agent attached to a surface thereof and reacting a silicone resin with the attached silicon-containing linking agent.

[0094] In some embodiments, the silicone resin comprises --Si--H moieties.

[0095] In some embodiments, the method further comprises curing the silicone resin to form a thermoset material.

[0096] In some embodiments, the thermosetting material is a silicone rubber. In some embodiments, the attached silicon-containing linking agent comprises a vinyl moiety.

[0097] In some embodiments, the step of reacting the silicone resin with the attached silicon-containing linking agent on the substrate comprises reacting -Si-H moieties in the silicone resin with vinyl moieties in the attached silicon-containing linking agent.

[0098] In some embodiments, the step of providing a substrate having a silicon-containing linking agent attached to a surface thereof further comprises providing a substrate comprising hydroxyls and / or carboxyls on a surface thereof and reacting the silicon-containing linking agent with the hydroxyls and / or carboxyls on the substrate.

[0099] In some embodiments, the step of reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate comprises hydrolyzing the silicon-containing linking agent to form reactive silanols and contacting the reactive silanols with the hydroxyls and / or carboxyls on the substrate.

[0100] In some embodiments, reacting the silicon-containing linking agent with hydroxyls and / or carboxyls on the substrate comprises plasma enhanced chemical vapor deposition (PECVD).

[0101] In some embodiments, providing a substrate comprising hydroxyls and / or carboxyls on a surface further comprises activating the substrate surface by plasma treatment, corona discharge, ozone treatment, chemical treatment, or flame treatment.

[0102] In some embodiments, the silicon-containing linking agent is a vinyl-functionalized silane coupling agent. In some embodiments, the vinyl-functionalized silane coupling agent has the formula: [ka] wherein R1, R2 and R3 in (A9) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least one of R1, R2 and R3 is hydroxyl or C1-C8 alkoxy; R1, R2, R3, R4, R5 and R6 in (A10) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least one of R1, R2, R3, R4, R5 and R6 is hydroxyl or C1-C8 alkoxy; X' is [ka] where R is H or C1-C8 alkyl; -X'- is [ka] and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene containing one or more heteroatoms selected from N and O. In some embodiments, the silicon-containing linking agent is gamma-methacryloxypropyltrimethoxysilane (γ-MPTS), vinyltrimethylsilane (VTMS) (3-acryloxylpropyl)trimethoxysilane, 1,1-bis(trimethoxysilylmethyl)ethylene, 1,2-bis(methyldiethoxysilyl)ethylene, and bis(3-trimethoxysilylpropyl)fumarate.

[0103] In some embodiments, the substrate is ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, or filled polymer. In some embodiments, the substrate is a printed circuit board (PCB). In some embodiments, the PCB is rigid. In other embodiments, the PCB is flexible. In some embodiments, the PCB comprises one or more sensors. In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor. In some embodiments, the PCB comprises a heating element. In some embodiments, the PCB comprises an electrical connector.

[0104] Numerous modifications in structure and widely different embodiments and applications of the invention will occur to those skilled in the art to which this invention pertains without departing from the scope of the invention as defined in the appended claims. The disclosures and descriptions herein are merely illustrative and are not intended to be in any sense limiting.

[0105] Various embodiments of the present disclosure will now be described, by way of illustrative example only, with reference to the accompanying drawings in which like elements have like reference numerals, and in which: [Brief description of the drawings]

[0106] [Figure 1A] 1 shows the surface chemistry prior to reaction between a thermoplastic material and a silanized substrate. [Figure 1B] 1 shows the interface between the bonded thermoplastic material and the substrate. [Figure 2A] FIG. 1 is a perspective view of an exemplary molded-in-one elbow according to one embodiment of the present disclosure. [Figure 2B] FIG. 13 is a longitudinal cross-sectional view of a molded elbow showing the placement of a PCB board. [Figure 3A] FIG. 1 is a perspective view of an exemplary molded elbow according to one embodiment of the present disclosure. [Figure 3B] FIG. 13 is a longitudinal cross-sectional view of a molded elbow showing the placement of a PCB board. [Figure 4A] FIG. 2 is a perspective view of an exemplary chamber molding according to one embodiment of the present disclosure. [Figure 4B] FIG. 1 is a longitudinal cross-sectional view of a molding chamber showing the placement of a PCB board. [Figure 4C] FIG. 13 is a perspective view of an exemplary chamber molding according to another embodiment of the present disclosure. [Figure 4D] FIG. 1 is a longitudinal cross-sectional view of a molding chamber showing the placement of a PCB board. [Figure 5A] FIG. 2 is a perspective view of an exemplary chamber molding according to one embodiment of the present disclosure. [Figure 5B] FIG. 1 is a longitudinal cross-sectional view of a molding chamber showing the placement of a PCB board. [Figure 6A] FIG. 2 is a perspective view of an exemplary chamber molding according to one embodiment of the present disclosure. [Figure 6B] FIG. 1 is a longitudinal cross-sectional view of a molding chamber showing the placement of a PCB board. [Figure 7A] FIG. 2 is a perspective view of an exemplary chamber molding according to one embodiment of the present disclosure. [Figure 7B] FIG. 1 is a longitudinal cross-sectional view of a molding chamber showing the placement of a PCB board. [Figure 8A] FIG. 1 is a perspective view of an exemplary breathing tube connector according to one embodiment of the present disclosure. [Figure 8B] FIG. 1 is a longitudinal cross-sectional view of a breathing tube connector showing the layout of a PCB board. [Figure 9A] FIG. 1 is a perspective view of an exemplary breathing tube connector according to one embodiment of the present disclosure. [Figure 9B] FIG. 1 is a longitudinal cross-sectional view of a breathing tube connector showing the layout of a PCB board. [Figure 10A] FIG. 1 is a perspective view of an exemplary heater for a humidifier, illustrating a PCB board configuration according to one embodiment of the present disclosure. [Figure 10B] FIG. 10B is a cross-sectional detail view of a heater for the example humidifier shown in FIG. 10A. [Figure 11] FIG. 2 is a perspective view of an exemplary heater for a humidifier illustrating a configuration of a PCB board according to one embodiment of the present disclosure. [Figure 12A]FIG. 2 is a perspective view of an exemplary heater for a humidifier illustrating a configuration of a PCB board according to one embodiment of the present disclosure. [Figure 12B] FIG. 12B is a cross-sectional detail view of a heater for the example humidifier shown in FIG. 12A. [Figure 13A] FIG. 2 is a perspective view of an exemplary heater for a humidifier illustrating a configuration of a PCB board according to one embodiment of the present disclosure. [Figure 13B] FIG. 13B is a cross-sectional detail view of a heater for the example humidifier shown in FIG. 13A. [Figure 14A] FIG. 1 is a diagram of an exemplary configuration of a respiratory therapy system. [Figure 14B] FIG. 1 is a diagram of an exemplary configuration of a respiratory therapy system. [Figure 14C] FIG. 1 is a diagram of an exemplary configuration of a respiratory therapy system. [Figure 15A] FIG. 1 is a perspective view of a printed circuit board heating element according to one embodiment of the present disclosure. [Figure 15B] FIG. 2 illustrates a top view of a printed circuit board heating element according to an embodiment of the present disclosure. [Figure 15C] FIG. 2 is a partial top view of a printed circuit board heating element according to one embodiment of the present disclosure. [Figure 15D] 1A-1D show top views of two embodiments of etched foil heating elements according to one embodiment of the present disclosure. [Figure 15E] 1 illustrates one embodiment of an etched foil heating element in a wrapped configuration. [Figure 16A] FIG. 1 is a perspective view of an example respiratory humidification system according to one embodiment of the present disclosure. [Figure 16B] FIG. 16B is a longitudinal cross-sectional view showing gas flow in the humidification system of FIG. 16A. [Figure 16C] FIG. 16B is a vertical cross-sectional view showing the water flow of the humidification system of FIG. 16A. [Figure 16D] FIG. 16B is a horizontal cross-sectional view of the respiratory humidification system of FIG. 16A. [Figure 16E] 1 shows a respiratory humidification system configured for use with a flow generation system. [Figure 16F] 1 shows a respiratory humidification system configured for use with a flow generation system. [Figure 17A] FIG. 1 illustrates a lattice microchannel water distribution pattern according to one embodiment of the present disclosure. [Figure 17B] FIG. 1 illustrates a radial microchannel water distribution pattern according to one embodiment of the present disclosure. [Figure 18A] FIG. 1 is a perspective axial cross-sectional view of a partial respiratory humidification system showing an example of a connection according to an embodiment of the present disclosure. [Figure 18B] FIG. 18B is a perspective side cross-sectional view of the respiratory humidification system of FIG. 18A including an example connection. [Figure 18C] FIG. 18B is a side view of the humidification system of FIG. 18A including an exemplary connection. [Figure 18D] FIG. 18B is a perspective assembly axial view of the humidification system of FIG. 18A. [Figure 19] FIG. 13 is a perspective view of a distribution tube connection wrapped over the edge of a heated surface according to one embodiment of the present disclosure. [Figure 20] FIG. 1 is a diagram of a porous media connection according to one embodiment of the present disclosure. [Figure 21A] FIG. 13 is a perspective view of a radial connection according to one embodiment of the present disclosure. [Figure 21B] FIG. 21B is a perspective cross-sectional view of the radial connector of FIG. 21A. [Figure 22A] FIG. 1 is a perspective view of a sandwich joint according to one embodiment of the present disclosure. [Figure 22B] FIG. 22B is a perspective cross-sectional view of the sandwich joint of FIG. 22A. [Figure 22C] FIG. 22B is a cross-sectional view of the sandwich joint of FIG. 22A attached to a humidification housing according to one embodiment of the present disclosure. [Figure 22D] FIG. 22B is a cross-sectional view of the sandwich joint of FIG. 22A attached to a humidification housing including a printed circuit board heating element according to one embodiment of the present disclosure. [Figure 23A] FIG. 13 is a perspective view of an alternative embodiment of a humidification system according to an embodiment of the present disclosure. [Figure 23B] FIG. 23B is a cross-sectional view of the humidification system of FIG. 23A. [Figure 23C]FIG. 23B is a cross-sectional view showing the top layer of the humidification system of FIG. 23A. [Figure 23D] FIG. 23B is a cross-sectional view showing the bottom layer of the humidification system of FIG. 23A. [Figure 24] FIG. 1 is a diagram of an in-line humidification system according to one embodiment of the present disclosure. [Diagram 25] FIG. 1 illustrates an embodiment of an air delivery system including a humidifier and / or humidification chamber. [Figure 26A] 1 shows peel force data for a PP / Scona molded part having a tie layer with a silicon-containing linker versus a control overmolded device. [Figure 26B] 1 shows peel force data for a PP / Scona molded part having a tie layer with a silicon-containing linker versus a control overmolded device. [Figure 27A] 1 shows peel force data for an Elvaloy molded part having a tie layer containing a silicon-containing linker versus a control overmolded device. [Figure 27B] 1 shows peel force data for an Elvaloy molded part having a tie layer containing a silicon-containing linker versus a control overmolded device. [Figure 28A] 1 shows peel force data for a PEX molded member having a tie layer with a silicon-containing linker versus a control overmolded device. [Figure 28B] 1 shows peel force data for a PEX molded member having a tie layer with a silicon-containing linker versus a control overmolded device. [Figure 29A] 1 shows peel force data for a Desmopan molded member having a tie layer containing a silicon-containing linker versus a control overmolded device. [Figure 29B] 1 is a scanning electron microscope image showing a PCB after the Desmopan molding having a tie layer containing a silicon-containing linker has been peeled off. [Figure 29C] 1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 29D]1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 30A] 1 is a scanning electron microscope image of the Surlyn molding material after it has been peeled off from a PCB to which it was previously bonded via a tie layer that includes a silicon-containing linker. [Figure 30B] 1 is a scanning electron microscope image of the Surlyn molding material after it has been peeled off from a PCB, to which it was bonded via a tie layer that includes a silicon-containing linker prior to peeling; and 12 is an elemental analysis of several regions of the scanning electron microscope image of the molding material. [Figure 30C] 1A-1D provide scanning electron microscope images of the PCB after the Surlyn molding material has been peeled away, along with elemental analysis of several areas of the scanning electron microscope images of the PCB. [Figure 30D] 1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 30E] 1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 31A] 1 is a scanning electron microscope image showing a PCB after a Nucrel molded member having a tie layer including a silicon-containing linker has been peeled off. [Figure 31B] 1 is a scanning electron microscope image showing a PCB after a Nucrel molded member having a tie layer including a silicon-containing linker has been peeled off. [Figure 31C] 1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 31D] 1 is a scanning electron microscope image of a control overmolded PCB device after peel testing. [Figure 32A] 1 shows peel force data for a Pebax molded member having a tie layer with a silicon-containing linker versus a control overmolded device. [Diagram 33] 1 illustrates various schemes according to aspects of the present disclosure. [Diagram 34]1 illustrates various schemes according to aspects of the present disclosure. [Diagram 35] 1 illustrates various schemes according to aspects of the present disclosure. [Diagram 36] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 37] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 38] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 39A] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 39B] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 39C] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 40A] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 40B] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 41A] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 41B] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 42A] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 42B] 1 illustrates various schemes according to aspects of the present disclosure. [Diagram 43] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 44A] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 44B] 1 illustrates various schemes according to aspects of the present disclosure. [Diagram 45] 1 illustrates various schemes according to aspects of the present disclosure. [Diagram 46] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 47] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 48] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 49] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 50] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 51] 1 illustrates various schemes according to aspects of the present disclosure. [Figure 52] 1 illustrates various schemes according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0107] The following description is merely exemplary in nature and is not intended to limit the present disclosure, its application or use in any way. For the purpose of clarity, the same reference numbers are used to identify similar elements in the figures. However, for convenience, some features that are present or referenced in some figures of the present disclosure are not shown or referenced in other figures of the present disclosure. Unless otherwise clearly required by the context, these omissions should not be interpreted as meaning that features omitted from one figure drawing cannot be equally incorporated or implemented in the configuration of the disclosed methods, devices and systems associated or incorporated in other figures. Conversely, unless otherwise clearly required by the context, the presence of some features in some figures of the present disclosure should not be assumed to mean that the disclosed methods, devices and systems associated or incorporated in such figures must necessarily include these features.

[0108] The term "alkyl" as used herein refers to a radical of a fully saturated hydrocarbon, including, but not limited to, methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, tert-butyl, n-hexyl, etc. When the term "alkyl" and more specific terms for alkyl (propyl, butyl, etc.) are used without specifying straight chain or branched, the term should be interpreted to include straight chain alkyls and branched alkyls.

[0109] The term "alkenyl" as used herein refers to a monovalent straight or branched chain radical of 2 to 20 carbon atoms containing a carbon double bond, including, but not limited to, 1-propenyl, 2-propenyl, 2-methyl-1-propenyl, 1-butenyl, 2-butenyl, and the like.

[0110] The term "alkoxy" as used herein refers to a straight or branched chain alkyl radical covalently bonded to a parent molecule through an -O- bond. Examples of alkoxy groups include, but are not limited to, methoxy, ethoxy, propoxy, isopropoxy, butoxy, n-butoxy, sec-butoxy, t-butoxy, and the like. When the term "alkoxy" and more specific terms for alkoxy (such as propoxy, butaoxy, etc.) are used without specifying straight chain or branched, the term should be interpreted to include straight chain alkoxy and branched alkoxy.

[0111] The term "alkylene" as used herein refers to a divalent saturated aliphatic radical that is considered to be derived from an alkene by the opening of a double bond or from an alkane by the removal of two hydrogen atoms to form a linker that connects molecular fragments together through their terminal carbon atoms. Examples include, but are not limited to, methylene (-CH2-), ethylene (-CH2CH2-), propylene (-CH2CH2CH2-), butylene (-(CH2)4-), pentylene (-(CH2)5-), hexylene (-(CH2)6-), and the like.

[0112] The term "heteroalkylene" as used herein refers to an alkylene group in which one or more of the carbon atoms are individually replaced with the same or different heteroatoms selected from oxygen, sulfur, and nitrogen. Heteroalkylene can have 1 to 4 heteroatoms, 1 to 3 heteroatoms, 1 to 2 heteroatoms, or 1 heteroatom. Examples of heteroalkylene include, but are not limited to, -CH2-O-, -CH2-CH2-O-, -CH2-CH2-CH2-O-, -CH2-NH-, -CH2-CH2-NH-, -CH2-CH2-CH2-NH-, -CH2-CH2-NH-CH2-, -CH2-CH2-NH-CH2-CH2-, -CH2-CH2-O-CH2-CH2-, -O-CH2-CH2-O-CH2-CH2-O-, -O-CH2-CH2-O-CH2-CH2-, and the like.

[0113] As used herein, the term "epoxy" refers to a three-membered ring ether.

[0114] The term "halo" as used herein refers to fluoro, chloro, bromo or iodo.

[0115] The term "amino" or "amine" as used herein refers to a primary amine, a secondary amine, or a tertiary amine.

[0116] As used herein, the term "glycidyl methacrylate" means [ka] group, where R is C1-C8 alkyl.

[0117] As used herein, the term "vinyl" refers to -CH=CH-.

[0118] As used herein, the term "succinic anhydride" means [ka] Refers to...

[0119] The term "carboxyl" as used herein refers to -C(O)OH.

[0120] In devices that deliver gas to a patient (e.g., respiratory devices and systems, insufflation devices and systems, etc.), it may be useful to heat the gas or monitor the humidity level, temperature and flow rate of the gas passing through the gas passageway. Delivering humidified heated gas to a patient may be beneficial during surgical procedures and respiratory therapy. Humidified gas may, for example, increase comfort for a patient using the delivery device and increase compliance. Thus, various substrates configured to include sensors or heating elements may be incorporated or embedded into gas delivery device components (e.g., respiratory device components, insufflation device components, etc.) such as connectors, gas flow paths, tubes or humidifier chambers. The substrates may be integrated into or embedded into the gas delivery device components using injection molding (either high pressure or low pressure). The injection molding may be insert molding or overmolding. For example, the substrate may be insert molded to form the respiratory device component.

[0121] Although various substrates can be physically incorporated or embedded into components for respiratory devices, in high humidity and / or high temperature environments, liquid ingress into the interface between the substrate and the molding material can occur. This can result in delamination of the molding material from the substrate. Delamination can cause the device to fail, resulting in leaks that often require expensive part replacement. Delamination can also result in loss of control and / or regulation of the system, which can cause one or more components to overheat and melt. If delamination occurs, one or more components of the device can short circuit (e.g., water contacting electrical components, water exiting the humidification system, etc.), resulting in failure of the device. If the device fails, the patient may be inconvenienced, or worse, the patient's safety may be compromised. Additionally, partial or complete delamination can make it difficult to clean and reuse the humidification device or its components. This contamination (e.g., bacteria) can increase the likelihood of respiratory infections and, in the case of air delivery devices, the possible introduction of foreign agents into the body.

[0122] As disclosed elsewhere herein, in some embodiments, a molding member is provided with a robust substrate-molding material interface (i.e., a bonding layer) that can prevent and / or delay delamination of the molding material from the substrate in high humidity and / or high temperature environments. In some embodiments, a bonding layer is provided between the molding material and the substrate to promote adhesion between the molding material and a substrate (or a portion thereof) that is integrated with, encapsulated by (e.g., embedded in) or bonded to the molding material. In some embodiments, the bonding layer attaches the molding material to the substrate via one or more of chemical or physical interactions. In some embodiments, a chemical bond can be formed between the substrate and the molding material. For example, forming a covalent bond (and / or chemical bond) between the substrate and the molding material can improve adhesion of the two different materials and delay or prevent delamination due to environmental stresses such as heat, pressure, mechanical force, or liquid ingress. Silicon-containing linking agents can be used to chemically bond (e.g., covalently bond, etc.) the two types of materials. The molding material can include thermoplastic and thermosetting materials.

[0123] In some embodiments, as disclosed elsewhere herein, a bonding layer can be formed at the interface between the surface of the molding material and the substrate. In some implementations, the substrate and molding material are not otherwise intermixed. In other words, the bulk material of the substrate remains unchanged as the bulk material of the molding material. In some embodiments, bonding between the two layers occurs only at the interface of these materials (i.e., through the bonding layer). In some implementations, it has been determined that substantially improved adhesion properties can be obtained even with a relatively small amount of interaction between surface functionalities at the interface of the molding material and the substrate (e.g., compared to epoxy resins, paints, etc.).

[0124] In some embodiments, as disclosed elsewhere herein, the bonding layer comprises a silicon-containing linker. In some embodiments, the bonding layer differs from a conventional adhesive layer in that it can comprise pendant groups from the molding material and pendant groups from the substrate. These pendant groups can interact to provide a strong bond between the materials in which they reside. In some implementations, the layer comprises a silicon-containing linker. In some implementations, as disclosed elsewhere herein, the bonding layer comprises one or more types of chemical interactions. The bonding layer can comprise one or more of covalent bonds, hydrogen bonds, van der Waals bonds, and / or ionic bonds. The bonding layer can comprise chemical bonds, physical bonds, or both. Physical bonds can include chain entanglements, etc.

[0125] In some embodiments, the molding material includes pendant groups (e.g., silicon-containing linkers, moieties of the molding material, etc.) that are covalently bonded to the molding material. In some embodiments, the substrate includes pendant groups (and / or functional groups) that are covalently bonded to the substrate. In some embodiments, the pendant groups (and / or functional groups) of the molding material interact with the pendant groups (and / or functional groups) of the substrate to provide a bonding layer. In some implementations, the bonding layer does not include a separate adhesive from the pendant groups and / or functional groups of the substrate and / or molding material. In some embodiments, the pendant groups and / or functional groups of the substrate form chemical bonds (e.g., covalent bonds, etc.) with matching pendant groups and / or functional groups of the molding material to bond the substrate and molding material together. In some implementations, as disclosed elsewhere herein, the chemical bonds do not occur through the bulk material (e.g., through the molding member and / or substrate), but instead occur only at the interface of the two materials.

[0126] 1A and 1B show bonding or coupling between a substrate 11 and a molding material 12. A substrate 11 is provided having a silicon-containing linking agent 13 attached to its surface, and a molding material 12 is bonded to the substrate 11. The molding material 12 (or a precursor thereof) includes a moiety 16 that can react with the silicon-containing linking agent 13. Bonding occurs when a moiety 15 in the attached silicon-containing linking agent 13 reacts with a moiety 16 in the molding material 12 to form a silicon-containing linker 14 that bonds the substrate 11 and the molding material 12 to each other (see FIG. 1B).

[0127] As disclosed herein, the molding member 10 can include a substrate 11 and a molding material 12, such as a thermoplastic or thermosetting material, with at least a portion of the substrate 11 coupled to the molding material 12. In some embodiments, the substrate 11 can be embedded in or integral with the molding material 12. The substrate 11 can be embedded in or integral with the molding material 12 using injection molding (either high pressure or low pressure). The injection molding can be insert molding or overmolding. In some embodiments, the substrate 11 can be insert molded into the molding material 12 to form the molding member 10. In some embodiments, the molding material 12 is an overmolded article on or around the substrate 11. At least a portion of the substrate 11 is coupled to the molding material 12 via a silicon-containing linker 14, with the bond between the silicon-containing linker 14 and the substrate 11 and the bond between the silicon-containing linker 14 and the molding material 12 being covalent.

[0128] The molded part can be formed by coupling a molding material 12 to a substrate 11. A substrate is provided having at least one silicon-containing linking agent attached to a surface thereof, and a molding material 12 is bonded to the at least one attached silicon-containing linking agent. In some embodiments, the molded part can be a part of a respiratory apparatus or device. Non-limiting examples of parts include housings for filters, gas conduits, chambers, inlet tubes, tube connectors, tube fittings, tube elbows, heating elements, patient interface parts, and water injection parts.

[0129] In some embodiments, as disclosed elsewhere herein, the disclosed bonding layer is adapted to prevent or slow delamination of the molding material from the substrate (or vice versa) due to high humidity and / or high temperature or rapid changes in conditions (e.g., temperature). In some embodiments, the high humidity is a humidity higher than the humidity of the ambient conditions and / or conditions in the gas source (e.g., compressed gas cylinder, etc.). In some embodiments, the high humidity includes gas (e.g., in a gas humidification system) having a relative humidity of about 40%, 50%, 60%, 70%, 80%, 90%, 99%, 99.9%, 100%, and / or a range including and / or spanning the values ​​listed above. In some embodiments, water (e.g., liquid water) poured onto the surface of the molding material can cause delamination. In some embodiments, the high temperature includes gas (e.g., in a gas humidification system) having a temperature higher than the ambient temperature. In some embodiments, the temperature of the gas in the gas delivery system is greater than or equal to about 15°C, 20°C, 25°C, 30°C, 35°C, 40°C, 45°C, 50°C, 60°C, and / or a range including and / or spanning these temperatures.

[0130] Silicon-Containing Linkers In embodiments where the molding material 12 is a thermoplastic material, the silicon-containing linker 14 can be a silane coupling linker, a silicon alkoxide, or a siloxane linker. In some embodiments, the silicon-containing linker has the following formula: [ka] In the formulas (L1) and (L2), ** is the point of attachment to the thermoplastic material; each R' is selected from hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, and -O- * are individually selected from the group consisting of * is a point of attachment to the substrate, and at least one of R' is -O- *Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N, -L- ** teeth, [ka] -L''- is selected from the group consisting of ** teeth, [ka] wherein: ** is the bond point to the thermoplastic material.

[0131] In some embodiments, the polymerized silane coupling linker is [ka] wherein X″ is independently X or -L- ** where X is selected from the group consisting of epoxy, a primary or secondary amine, or succinic anhydride; X''' is H or -L''- ** and at least one of X'' is -L- ** and at least one of R' is -O- * and at least one of X''' is -L''- ** and p is an integer greater than 1.

[0132] In some embodiments, the silicon-containing linker has the formula: [ka] or a polymerized silicon alkoxy linker thereof; wherein R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxyl, —O— * Or -O- ** and * is the attachment point to the substrate, **is a bond point to the thermoplastic material, and at least one of R'' is -O- * and at least one of R'' is -O- ** and Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0133] In some embodiments, the polymerized silicon alkoxy linker is [ka] where p is an integer greater than 1.

[0134] In some embodiments, the silicon-containing linker has the formula: [ka] or a polymerized siloxane linker thereof; * and * is a point of attachment to the substrate; each Z′ is an epoxy, a primary amine, a secondary amine, a succinic anhydride, and -L- ** is selected from the group consisting of ** is the bond point to the thermoplastic material, -L- ** teeth, [ka] Z″ is selected from the group consisting of hydrogen or -L″- ** and -L''- ** teeth, [ka] is selected from the group consisting of ** is a bond point to the thermoplastic material; at least one of Z is -O- * and at least one of Z' is -L- ** or at least one of Z'' is -L''-** Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- * Or -O- ** and * is the attachment point to the substrate, ** is a bond point to the thermoplastic material, and at least one of Z'' is -O- * and at least one of Z''' is -O- ** m is an integer greater than or equal to 1; and n is an integer greater than or equal to 1. In some embodiments, m and n can independently be integers from 1 to 200, 1 to 70, 1 to 50, 1 to 30, or 1 to 10.

[0135] In some embodiments, the siloxane linker can be further polymerized to form a polymerized siloxane linker (e.g., a polysiloxane linker). A polymerized siloxane can be formed when a hydroxyl group on a siloxane linker structure condenses with a hydroxyl group on another siloxane linker.

[0136] In embodiments where the molding material is a thermosetting material, such as silicone rubber, the silicon-containing linker may be of the following formula: [ka] or a polymerized vinyl-functionalized silane coupling linker thereof; ** is the point of attachment to the thermosetting material; each R' is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, or -O- * and * is a point of attachment to the substrate, and at least one of R' is -O- * and -L'- in (L9). * teeth [ka] or [ka] And in (L10) [ka] teeth [ka] where R is H or C1-C8 alkyl; and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0137] In some embodiments, the polymerized silane coupling linker is [ka] wherein V is independently X′ or -L′- * and V' is independently -X'- or [ka] and X' is [ka] and;-L'- ** teeth [ka] and -X'- is [ka] and; [ka] teeth [ka] wherein R is H or C1-C8 alkyl; R' is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, or -O- * and * is a point of attachment to the substrate, and at least one of R' is -O- * and p is an integer greater than 1.

[0138] In some embodiments of the formulas described herein, p can be an integer from 2 to 200, 2 to 70, 2 to 50, 2 to 30, or 2 to 10. In some embodiments of the formulas described herein, m and n can independently be integers from 1 to 200, 1 to 70, 1 to 50, 1 to 30, or 1 to 10. In some embodiments, p is an integer greater than or equal to about 1, 10, 50, 100, 200, or a range inclusive and / or spanning the recited values.

[0139] In some embodiments, the silicon-containing linker described herein may be in polymerized form when one or more silanol groups in a structure condense with silanol groups in another structure. In general, polysiloxane can be used to describe siloxane bonds (Si-O-Si) that bond together to become a polymer. For example, two or more molecules of a silane coupling linker or silicon alkoxy linker can be polymerized to form a chain or cluster of siloxane linkers, and the chain / cluster of siloxane linkers can be further polymerized to form a polysiloxane linker. Two or more siloxane linkers can also be further polymerized to form a polymerized siloxane linker, which is also a polysiloxane linker. Thus, the silicon-containing linker described herein can include any siloxane or polysiloxane formed by polymerization of a simpler form of a silicon-containing linker.

[0140] In some embodiments, the silicon-containing linker is covalently bonded to the thermoplastic material, hi some embodiments, the silicon-containing linker is covalently bonded to the substrate.

[0141] Silicon-containing linking agents Certain silicon-containing linking agents may be suitable for covalent bonding with thermoplastic materials. The silicon-containing linking agent may be a silane coupling agent, a silicon alkoxide, or a siloxane. In some embodiments, the silane coupling agent has the following formula: [ka] wherein R1, R2, and R3 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl, and C1-C8 alkoxy, and at least one of R1, R2, and R3 in (A1) is hydroxyl or C1-C8 alkoxy, Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; and X is selected from the group consisting of epoxy, primary or secondary amine, and succinic anhydride.

[0142] In some embodiments, the silane coupling agent has the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2, R3, R4, R5 and R6 in (A2) is hydroxyl or C1-C8 alkoxy; and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0143] A fully hydrolyzed silanol has three hydroxyl groups in formula (A1) and six hydroxyl groups in formula (A2). In some embodiments, as a reactive silanol, formula (A1) can have one, two, or three hydroxyl groups, and formula (A2) can have one, two, three, four, five, or six hydroxyl groups. In embodiments where any of R1, R2, R3, R4, R5, and R6 is a hydroxyl group, the silane coupling agent is a reactive silanol. In embodiments where any of R1, R2, R3, R4, R5, and R6 is a C1-C8 alkoxy group, one or more of the C1-C8 alkoxy groups can be hydrolyzed to form a hydroxyl group, thereby making the silane coupling agent a reactive silanol.

[0144] In some embodiments, silane coupling agents having hydrolyzable groups (e.g., alkoxy) can form polysiloxanes after the sol-gel process. The sol-gel process involves hydrolysis of the silane to form reactive silanols and subsequent condensation of the silanol groups. Bipodal silanes can form six bonds to the substrate, whereas non-bipodal silanes can only form three bonds to the substrate. Thus, in some embodiments, bipodal silanes (e.g., formula (L2)) have much higher inherent hydrolytic stability than non-bipodal silanes (e.g., formula (L1)). Thus, in some embodiments, bipodal silanes can provide better adhesion to the substrate than non-bipodal silanes, and can also have higher resistance to heat and water ingress.

[0145] Therefore, the molding member containing the bipodal silane coupling agent can have a longer shelf life.The commercially available bipodal silane with desired functional group is not always available.However, by using the bipodal silane without functional group in combination with the non-bipodal silane with desired functional group, suitable silicon-containing linking agent can be formed.In such a case, the above-mentioned benefits of the bipodal silane are maintained.Therefore, in some embodiments, the combination of the bipodal silane and the non-bipodal silane can affect the substrate bonding, hydrolysis stability and mechanical strength of polysiloxane by increasing crosslink density by using the combination of the bipodal silane and the non-bipodal silane.

[0146] In some embodiments, in a sol-gel process, a silane coupling agent (containing a functional group X) can be hydrolyzed and condensed with another functional bipodal silane to form a polysiloxane containing a functional group X.

[0147] Examples of silane coupling agents include the following: [ka]

[0148] In some embodiments, the silicon alkoxide has the formula: [ka] wherein R1, R2, R3 and R4 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least two of R1, R2, R3 and R4 in (A3) are independently hydroxyl or C1-C8 alkoxy.

[0149] In some embodiments, the silicon alkoxide has the formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least two of R1, R2, R3, R4, R5 and R6 in (A4) are independently hydroxyl or C1-C8 alkoxy; and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0150] A fully hydrolyzed silanol has four hydroxyl groups in formula (A3) and six hydroxyl groups in formula (A5). In some embodiments, as a reactive silanol, formula (A3) can have one, two, three, or four hydroxyl groups, and formula (A4) can have one, two, three, four, five, or six hydroxyl groups. In embodiments where any of R1, R2, R3, R4, R5, and R6 is a hydroxyl group, the silicon alkoxide is a reactive silanol. In embodiments where any of R1, R2, R3, R4, R5, and R6 is a C1-C8 alkoxy group, one or more of the C1-C8 alkoxy groups can be hydrolyzed to form a hydroxyl group, thereby making the silicon alkoxide a reactive silanol.

[0151] Some examples of silicon alkoxides are provided below. [ka]

[0152] In some embodiments, the siloxane has the following formula: [ka] wherein R1, R2, R3, R4, R5 and R6 are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; and at least one of R1, R2, R3, R4 and R5 in (A5), at least one of R1, R2, R3, R4, R5 and R6 in (A6) and (A7), and at least two of R1 and R2 in (A8) are independently selected from the group consisting of hydroxyl or is a C1-C8 alkoxy; Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl, or a C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; X is selected from the group consisting of epoxy, a primary or secondary amine, and succinic anhydride; m is an integer equal to or greater than 1; and n is an integer equal to or greater than 1. In some embodiments of all of the formulas described herein, m and n can be independently integers from 1 to 200, 1 to 70, 1 to 50, 1 to 30, or 1 to 10.

[0153] Examples of siloxanes include aminopropyl silsesquioxane, aminoethyl aminopropyl silsesquioxane, aminopropyl silsesquioxane-methyl silsesquioxane, and non-functional siloxanes. [ka]

[0154] Certain silicon-containing linking agents may be suitable for covalent bonding with thermosetting materials, such as silicone rubber. In some embodiments, the silicon-containing coupling agent has the formula: [ka] wherein R1, R2 and R3 in (A9) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy, and at least one of R1, R2 and R3 in (A9) is hydroxyl or C1-C8 alkoxy; R1, R2, R3, R4, R5 and R6 in (A10) are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl and C1-C8 alkoxy; at least one of R1, R2, R3, R4, R5 and R6 in (A10) is hydroxyl or C1-C8 alkoxy; X' is [ka] and -X'- is [ka] where R is H or C1-C8 alkyl; and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

[0155] Examples of vinyl-containing silane coupling agents include the following: [ka]

[0156] Similar to the above-mentioned silane coupling agents, the vinyl-functionalized silane coupling agents can also be polymerized to form oligomers and polymers (such as siloxanes and / or polysiloxanes). Thus, polymerized vinyl-functionalized silane coupling agents are also within the scope of the present application.

[0157] substrate Suitable substrates can include materials with hydroxyl (-OH)-containing surfaces. Substrates can also include materials that can be activated to form hydroxyl groups or hydroxyl-bearing groups on the surface. The -OH groups can react with silanols derived from or already present in the silicon-containing linking agent, resulting in anchoring of the silanols derived from the silicon-containing linking agent. The more -OH groups present on the substrate surface, the more sites available for bonding to silanols derived from or present in the silicon-containing linking agent. The silanols derived from the silicon-containing linking agent that contain two or more alkoxy groups can form two or more bonds with the substrate.

[0158] In some embodiments, the surface of the substrate has -OH groups or moieties that contain -OH groups. Some surfaces, such as glass, react with silicon-containing linking agents without any pretreatment. Other surfaces, such as printed circuit boards (PCBs), may require pretreatment or activation before the silanols derived from or present in the silicon-containing linking agents can be attached. The surface of the substrate can be activated through plasma treatment, corona discharge, ozone treatment, flame treatment, or chemical treatment with an oxidizing agent such as chromic acid. These surface treatments promote surface oxidation and hydroxylation, which produces a wide variety of oxygen moieties. In chemical analysis of treated substrates, carbonyl (-C=O), carboxyl (-COOH), hydroxyl (-OH) and hydroperoxide (-OOH) groups are commonly found.

[0159] Plasma processing (i.e., low pressure plasma processing and atmospheric pressure plasma processing, see FIG. 33) involves partially ionizing a gas by subjecting it to an electric field at high frequency. The induced free electrons are accelerated by the electric field, which causes them to collide with other atoms in the gas. As a result, more electrons are released and a mixture of neutral atoms, atomic ions, molecular ions, free radicals, and molecules existing in excited and ground states are produced.

[0160] Corona discharge is an electrical process involving ionization of air in contact with a substrate. Typically, an electrode at high potential in the air passes a high voltage, e.g., 10 kilovolts, ionizing it and creating a plasma around the electrode. The ionized gas, positive ions, and electrons are then passed through an electric field, increasing their kinetic energy. A ground electrode then attracts the ionic species, completing the circuit and maintaining the current to the surface of the substrate.

[0161] Ozone treatment uses ultraviolet light and ozone to both clean and modify substrate surfaces. The process involves ultraviolet irradiation, which causes photolysis of contaminating organic compounds on the surface, generating ions, free radicals, excited molecules, and neutral molecules on the surface.

[0162] Flame treatment involves radical reactions due to the combustion of air and combustible gases. A plasma field is created when combustible gases and air are combined and burn to form an intense blue flame. Brief exposure to excited particles in this flame affects the distribution and density of electrons and polarized surface molecules on the surface of the substrate through oxidation. Water and carbon dioxide are the final reaction products. However, the radical reaction also produces radicals consisting of oxygen species (i.e., -OH, HO2, H2O2, and O2).

[0163] The substrate may be a portion of a printed circuit board (PCB) and may include one or more of ceramic, fiberglass, fiberglass, sized fiberglass, silicone rubber, metal, etched foil, or filled polymers such as glass-reinforced polymers. In some embodiments, the filled polymer may include talc, carbon black, carbon fiber, basalt fiber, silica powder, and combinations thereof. In some embodiments, the sized fiberglass includes fiberglass that has been chemically treated with a sizing agent to allow for better bonding with the PCB matrix. In some embodiments, the substrate includes inorganic materials, organic materials, or both. In some embodiments, the portion of the substrate that includes the linker is organic. In some embodiments, the portion of the substrate that includes the linker is not inorganic. In some embodiments, the substrate does not include inorganic materials.

[0164] In some embodiments, the substrate is layered. In some embodiments, the substrate, its layers and / or its outer surface comprises a polymer, for example an organic polymer. In some embodiments, the substrate, its layers and / or its surface comprises one or more of an epoxy resin, fiberglass, phenol formaldehyde resin, paper or polyester resin. In some embodiments, the substrate, its layers and / or its surface comprises one or more of a polyester, a polyetherimide or a polyimide. In some embodiments, the substrate, its layers and / or its surface comprises one or more of an epoxy (which may be solvent or water-based) or a polyethylene. In some embodiments, a material (e.g., a conductive material, a conductive track, etc.) can be provided on the substrate. In some embodiments, the material comprises one or more of copper or aluminum. In some embodiments, the substrate, its layers and / or its outer surface comprises an ink. In some embodiments, the ink is colored and can provide colored text (e.g., white, black, orange or other color). In some embodiments, the substrate, its layers, its outer surface and / or the material provided on the substrate comprises one or more heat or flame resistant materials.

[0165] In some embodiments, the PCB includes a substrate. In some embodiments, the PCB includes a substrate and one or more conductive tracks. In some embodiments, the PCB includes a silk screen ink (e.g., an ink disclosed elsewhere herein). In some embodiments, the PCB includes a solder mask (which may be pigmented). In some embodiments, the solder mask includes one or more of an epoxy or polyethylene (which may be solvent or water-based). In some embodiments, the PCB or the conductive tracks include a conductor (e.g., one or more of copper or aluminum). In some embodiments, the PCB includes a thermally conductive material (e.g., aluminum as a heat sink). In some embodiments, the PCB includes a bulk material (e.g., one or more of an epoxy resin, fiberglass, phenol formaldehyde resin, paper, or polyester resin, which may be provided as a substrate). In some embodiments, the PCB includes a flexible material (e.g., one or more of a polyester, polyetherimide, or polyimide). In some embodiments, the PCB is arranged as a layered stack such that a layer of flexible material is under a bulk material layer or conductor, the bulk material layer is under or over the conductor, the conductor or bulk material is under a solder mask, and the solder mask is under a silk screen ink. In some embodiments, one or more of the layers are optional and any layer can be omitted. For example, in some embodiments, the layered PCB is free of silk screen, solder mask, and / or flexible material. For example, the PCB can be an FR-4 PCB, which is a PCB that includes an FR-4 laminate (e.g., a composite material made of woven glass fabric with an epoxy resin binder that is flame retardant). In some embodiments, the PCB or portions thereof are heat resistant or flame retardant.

[0166] The substrate, if part of a PCB, can be rigid or flexible. In some embodiments, the substrate can be configured to have one or more sensors thereon (e.g., a PCB can include a substrate with one or more sensors). For example, the sensors can be temperature sensors, pressure sensors, flow sensors, humidity sensors, fluid level sensors. In some embodiments, the substrate can be configured to include a heating element or an electrical connector.

[0167] Thermoplastic Materials The thermoplastic material can have at least one moiety capable of reacting with the silicon-containing linking agent. For example, the moiety of the thermoplastic material capable of reacting with the silicon-containing linking agent can be selected from the group consisting of amino, carboxyl, epoxy, succinic anhydride, and silane. In some embodiments, the thermoplastic material is hydrophilic. In some embodiments, the thermoplastic material is hydrophobic. Useful thermoplastic materials can include acrylate copolymers, acrylate terpolymers, maleic anhydride grafted polymers, thermoplastic polyurethanes (TPUs), polyamides, and crosslinkable polymers. For example, the thermoplastic material may be selected from one of the following: ethylene / methacrylic acid copolymer, propylene / methacrylic acid copolymer, ethylene / methacrylic acid / acrylate terpolymer, propylene / methacrylic acid / acrylate terpolymer, ethylene / acrylate copolymer, propylene / acrylate copolymer, succinic anhydride grafted polypropylene, succinic anhydride grafted polyethylene, polyurethane, polyamide, ethylene / butyl acrylate / glycidyl methacrylate terpolymer, propylene / butyl acrylate / glycidyl methacrylate terpolymer, ethylene / glycidyl methacrylate copolymer, propylene / glycidyl methacrylate copolymer, crosslinkable polyethylene, crosslinkable polypropylene, and crosslinkable polyolefin. In some embodiments, the thermoplastic resin comprises polypropylene random copolymers; maleic anhydride functionalized polypropylenes; thermoplastic aromatic polyether based polyurethanes; polyether block amides; ethylene / methacrylic acid (E / MAA) copolymers; terpolymers of ethylene, methacrylic acid and acrylates; trimethoxysilyl modified polyethylenes; ethylene-butyl acrylate-glycidyl methacrylate terpolymers; and / or combinations thereof.In some embodiments, the thermoplastic resin comprises Ranpelen J-560S (polypropylene random copolymer), Scona TPP9012 (maleic anhydride functionalized polypropylene); Desmopan 9370A (thermoplastic aromatic polyether based polyurethane), Pebax MV1074 (polyether block amide), Surlyn 9020 (ethylene / methacrylic acid (E / MAA) copolymer), Nucrel AE (ethylene, methacrylic acid and acrylate terpolymer), PEX (trimethoxysilyl modified polyethylene), Elvaloy PTW (ethylene-butyl acrylate-glycidyl methacrylate terpolymer) and / or combinations thereof.

[0168] The thermoplastic material can be overmolded onto the substrate or the substrate can be embedded in the thermoplastic material using insert molding. In some embodiments, the thermoplastic material has a Shore A hardness greater than about 30, greater than about 35, greater than about 40, greater than about 50, greater than about 60, greater than about 70, greater than about 80, greater than about 90, or greater than about 95. In some embodiments, the thermoplastic material has a Shore A hardness greater than about 30, 35, 40, 50, 60, 70, 80, 90, 95, or a range including and / or spanning the values ​​set forth above. In some embodiments, the thermoplastic material surface (e.g., an overmolded surface, an insert molded surface, an injection molded surface, etc.) can comprise micro- or nano-sized structures or features. For example, the surface can have microchannels or microstructures. In some embodiments, the microchannels can extend in only one direction. In some embodiments, the microchannels can be radially distributed from a single point or can be interconnected or a pattern. The thermoplastic surface can be immersed in a gas flow.

[0169] Silanization of the substrate surface Silane coupling agents can be attached or deposited on substrate surfaces through wet chemical or plasma enhanced chemical vapor deposition (PECVD) processes. Substrate surfaces with -OH functional groups or other hydroxyl-containing groups, such as carboxyl, can react with silanol moieties to form covalent bonds.

[0170] wet chemistry In some embodiments, the wet chemical treatment can be a dip-coating, spin-coating or spray-coating process. The substrate is coated with a solution containing silanols, either derived from silicon-containing linking agents (such as silane coupling agents and silicon alkoxides) or already present in silicon-containing linking agents (such as siloxanes).

[0171] As shown in FIG. 34, in the case of silane coupling agents and silicon alkoxides, the wet chemical treatment starts with a sol-gel process, which involves hydrolysis of the alkoxy groups in the silane coupling agent or silicon alkoxide. This results in a reaction intermediate that is a hydroxyl-silicon species or silanol (containing Si-OH). Thus, the silane solution consists of a small amount of water to hydrolyze the silane. In some embodiments, an organic solvent is used to adjust the viscosity of the reaction solution. In some embodiments, the reaction can use an acid or base catalyst. FIG. 34 shows an example of the hydrolysis reaction of a silane coupling agent.

[0172] If the silicon-containing linking agent is a siloxane, hydrolysis is not necessary. The siloxane already has a hydroxyl group suitable for covalent bonding with the substrate. Thus, the hydrolysis of the silane coupling agent or silicon alkoxide forms a reactive silanol, and the siloxane is a reactive silanol.

[0173] The reactive silanols can then react with, for example, hydroxyl groups on the substrate surface through a condensation reaction. This process forms a covalent bond between the reactive silanols and the substrate, such that the reactive silanols form silicon-containing linkers. Thus, the reactive silanols attach or stick to the surface of the substrate. Because the condensation reaction requires the elimination of water, the coated substrate is typically cured at high temperatures to accelerate the water removal process. This process is shown later in FIG. 35 for silane coupling agents.

[0174] Reactive silanol species can also react with other silanol species to form oligomers through condensation reactions. Two silicon centers are crosslinked with each other, resulting in the formation of siloxanes (Si-O-Si bonds). When at least one of R1 and R3 contains an alkoxyl group, the alkoxyl group can also be hydrolyzed to -OH, and the -OH moiety in the siloxane can also react with the hydroxyl group on the substrate surface, resulting in the siloxane being attached to the substrate surface.

[0175] Once reactive silanol species are formed, the silanol species on one silane coupling agent can also react with silanol species on another silane coupling agent to form oligomers through a condensation reaction, as shown in Figure 36 for the silane coupling agents.

[0176] With regard to siloxane, it can be adhered to a substrate such as an oxygen plasma treated PCB via wet chemistry, for example as shown in FIG.

[0177] Plasma-enhanced Chemical Vapor Deposition (PECVD) Silane coupling agents or silicon alkoxides can also be attached to substrate surfaces by PECVD. Without being bound by theory, silane coupling agents or silicon alkoxides undergo fragmentation caused by collisions with radicals, ions and free electrons in plasma. The derived silane radicals are then absorbed on the substrate surface and form chemical bonds at reactive sites. Silane radicals can also condense with other silane radicals and polymerize to form siloxane networks.

[0178] When the silane coupling agent is attached to the substrate surface through plasma treatment (see FIG. 38), the hydrolysis reaction of the silane is not necessary because the silane coupling agent is activated through plasma treatment. The activated silane can react with -OH groups and carboxyl groups (-COOH) on the substrate surface to form covalent bonds. Similarly, as discussed herein, siloxanes can be generated during the reaction, and the siloxanes can also be attached to the substrate surface. Both low pressure / vacuum plasma treatment and atmospheric pressure plasma treatment can be utilized.

[0179] Bonding of Thermoplastic Materials to Silanized Substrates As shown in Figure 38, the silanized substrate has multiple pendant functional groups X on its surface, which allows a thermoplastic material containing a suitable functional group W to be cast onto the silanized substrate. The reaction between X and W results in a covalent bond that increases adhesion between the substrate and the thermoplastic material.

[0180] In some embodiments, the silicon-containing linking agent can be a silane coupling agent or a siloxane. The silane coupling agent or the siloxane has a functional group X.

[0181] In some embodiments, the reaction between the X group in the silane coupling agent or siloxane and the W group in the thermoplastic material is based on an epoxy ring-opening reaction, which can be achieved by reacting an epoxy with a carboxyl or an amine.

[0182] As shown in FIG. 39A, epoxy rings bridged by opened carboxyl groups produce two different reaction products: esters of the primary hydroxyl groups and esters of the secondary hydroxyl groups.

[0183] Esters of primary hydroxyl groups can undergo esterification reactions with epoxy rings to form ethers, as shown in Figure 39B.

[0184] Esters of secondary hydroxyl groups can also undergo esterification reactions with carboxyl groups to produce the full ester and water as a by-product, as shown in Figure 39C.

[0185] As shown in Figures 40A and 40B, the epoxy rings can be opened and crosslinked by primary or secondary amines.

[0186] In some embodiments, the reaction between the X group in the silane coupling agent or siloxane and the W group in the thermoplastic material is based on a succinic anhydride ring-opening reaction, which can be accomplished by reacting succinic anhydride with a primary amine.

[0187] As shown in FIG. 41A, succinic anhydride can be ring-opened and crosslinked with primary amines forming amide and imide bonds, respectively.

[0188] The succinic anhydride ring can react with a hydroxyl group to form an ester bond, as shown in Figure 41B.

[0189] In some embodiments, the silicon-containing linking agent can be a silicon alkoxide. In this embodiment, the silicon alkoxide can be subjected to a sol-gel process. During the sol-gel process, the silicon alkoxide can hydrolyze to form reactive silanols, as shown in FIG. 42A.

[0190] In some embodiments, the reaction between the silanol groups derived from the silicon alkoxide and the hydroxyl groups in the thermoplastic material is based on a condensation reaction.

[0191] As shown in FIG. 42B, the silanol groups can react with and thereby be crosslinked by the hydroxyl groups in the thermoplastic material.

[0192] Surprisingly, thermoplastic materials can bond to substrates to provide the desired protective properties. Protective coatings exist that are covalently bonded to substrates, but these protective coatings are paints and resins that contain reactive groups that react with chemical groups on the substrate. Paints and resins are beneficial in terms of low viscosity, excellent wetting properties, and relatively long curing cycles. When the paint dries and the resin cures, the reactive sites on the substrate and in the paint are relatively likely to come into contact with each other, and therefore covalent bonds can be easily formed.

[0193] In contrast, thermoplastic resins are high viscosity materials whose viscosity increases rapidly when the thermoplastic material cools after contact with the substrate. Therefore, chemical bonds between reactive groups in the thermoplastic resin and chemical groups on the substrate are not expected to form, and good covalent bonds are especially not expected. It is not expected that the molded thermoplastic materials disclosed herein and the substrate can form covalent bonds and / or layers with improved adhesion.

[0194] thermoset material In some embodiments, a thermosetting material is provided as the molding material, as disclosed elsewhere herein. In some embodiments, the thermosetting material is an epoxy, polyurethane, or silicone rubber. In some embodiments, the thermosetting material is a liquid silicone rubber (LSR) system, which is a two-component platinum-catalyzed silicone elastomer. The part A component is polydimethylmethylvinylsiloxane containing vinyl functional groups and a platinum catalyst. The part B component is polydimethylmethylhydrogensiloxane containing a hydride crosslinker and inhibitor. In the LSR curing process, the catalyst promotes the addition reaction of -CH=CH2 groups in part A with ≡SiH in part B. The addition reaction of parts A and B is shown in FIG. [ka]

[0195] In embodiments where LSR is used as the molding material (or other thermosetting material as disclosed elsewhere herein), the silane coupling agent gamma-methacryloxypropyltrimethoxysilane ("γ-MPTS", also known as "methacryloxypropyltrimethoxysilane" or "MPTMS"), vinyltrimethylsilane (VTMS) (3-acryloxypropyl)trimethoxysilane, 1,1-bis(trimethoxysilylmethyl)ethylene, 1,2-bis(methyldiethoxysilyl)ethylene, or bis(3-trimethoxysilylpropyl)fumarate can be used to provide a covalent bond between the PCB and the thermosetting material (e.g., silicone rubber).

[0196] The attachment of vinyl-functionalized silanes onto PCBs can be performed in a similar manner to the method shown above. The vinyl groups (-CH=CH2) in γ-MPTS and VTMS, like the vinyl groups in part A of LSR, can react with platinum catalyst in part A to form crosslinks with ≡Si-H in part B. Figures 44A and 44B show the chemical reaction of γ-MTPS with LSR. A vinyl-functionalized silane coupling agent such as γ-MPTS is first attached to the substrate, and then the silicone resin reacts with the attached vinyl-functionalized silane coupling agent. The silicone resin then cures to form silicone rubber.

[0197] Molded parts / components Any part that includes a molding material, such as a thermoplastic or thermosetting material, to which a substrate is embedded or coupled / bonded can benefit from increased adhesion at the interface of these two different materials. Increased adhesion is particularly beneficial when the interface between the molding material and the substrate is exposed to harsh environments, such as chemical or salt exposure, high temperature and / or humidity. For simplicity, when referring to a substrate that is coupled / bonded to a molding material, the bond between the substrate and the molding material may simply be referred to as a bond layer. Whenever a bond layer is mentioned, the bond layer may include a silicon-containing linker, as disclosed elsewhere herein.

[0198] The shaped member may be a housing, a gas conduit, a chamber, an inhalation tube, a tube connector, a patient interface part (e.g., a respiratory gas interlace and / or a surgical gas interface), a tube fitting, a tube elbow, a heating element, a water infusion part, or any part for a filter for a breathing circuit or device. The shaped member may also be a part or the entire housing, a gas conduit, a chamber, a tube connector, a patient interface part, a tube fitting, a tube elbow, a heating element, a water infusion part, or any part for a filter for an air delivery circuit or device. To understand the present disclosure in more detail, reference is made to various parts that may be used in a breathing device, an air delivery device, or other device that provides air and / or gas flow to a patient, especially when increased adhesion may be applied. The humidifiers and / or humidification chambers described herein may be used, for example, in any suitable medical / surgical procedure, as well as in any suitable medical humidification system with a gas delivery circuit, such as, for example, invasive ventilation, non-invasive ventilation, high flow delivery, positive pressure delivery (e.g., CPAP), etc.

[0199] 2A and 2B show an example of a molded part, in this case a molded elbow 100 that is a part of a respiratory device. The PCB 101 is inserted into and through the wall of the molded elbow 100 by injection molding the elbow around the PCB 101. A portion of the PCB 101 is exposed to the interior of the molded elbow 100 (i.e., not covered by the molding material 103) and is therefore exposed to the gas flow through the molded elbow 100. The PCB 101 can be configured to include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. The sensors can be protrusions on the exposed portion of the PCB. In some embodiments, the PCB can also be configured to include an electrical connection to the respiratory device or component. As shown, the interface 102 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molded part here, a covalent bond is formed at the interface 102 between the PCB 101 and the molding material 103 of the molded elbow 100.

[0200] 3A and 3B, a portion of the PCB 101 is embedded or encapsulated within a recess in the wall of the molded elbow 100 by injection molding the elbow around the PCB 101. The PCB 101 can be configured to include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. The PCB 101 can also be configured to include an electrical connection to a breathing device or component. As shown, the interface 102 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molded member here, a covalent bond is formed at the interface 102 between the PCB 101 and the molding material 103 of the molded elbow 100. As shown in FIGS. 3A and 3B, in some embodiments, as exemplified by the molded elbow 100, the molded member can include an interior region 150 and an exterior region 151. In some embodiments, although shown as a separate piece in FIGS. 3A and 3B, as disclosed elsewhere herein, the shaping member may be part of a humidified gas flow system (e.g., a gas conduit of a gas flow path) such that the interior region is substantially isolated from the exterior region. In some embodiments, the interior region is exposed to and / or includes a gas environment that is different from the gas environment of the exterior region (e.g., the interior and exterior regions are exposed to one or more of different gases, different ratios of gases, different humidity, different temperatures, etc.). In some embodiments, the shaping member is part of a substantially closed system. In some embodiments, features in the interior region are exposed to more severe conditions (e.g., higher temperatures, higher humidity, higher pressures, etc.) than the exterior region. In some embodiments, the system is not closed.

[0201] In some embodiments, as shown in FIGS. 3A and 3B, the molding material can encapsulate at least a portion of the substrate (e.g., PCB). In some embodiments, the PCB (or substrate) can be fully encapsulated, e.g., any conductive parts (e.g., conductive tracks or electrical contacts) are covered or substantially covered by the molding material. In some embodiments, the PCB (or substrate) can be encapsulated such that it is not directly exposed to the gas flow of the respiratory or medical air delivery system (e.g., the environment within the interior region 150 of the molding member of the gas flow path). In some embodiments, the molding material 103 physically isolates the PCB 101 from the gas flow path (e.g., the interior region 150). In some embodiments not shown, the molding material encapsulates the PCB such that the PCB physically isolates the PCB (or substrate) from the exterior region of the gas flow path.

[0202] In some embodiments where the molding material encapsulates the substrate (e.g., of a PCB) (e.g., isolated from the humidified and / or heated gases of the humidification device) (as shown in FIGS. 3A and 3B), delamination can be delayed and / or prevented for a longer duration than if a portion of the substrate of the molding member were directly exposed to the humidified conditions. For example, in some embodiments, the encapsulation can prevent liquids, vapors, and gases from the humidification device from interacting with the molding material-substrate interface (e.g., a bonding layer). In some embodiments, the intersection of the molding material and the substrate (e.g., of a PCB) is more susceptible to delamination when the substrate (or PCB) is encapsulated. In some embodiments where a bonding layer is present, the encapsulation prevents or blocks water or gas from accessing the bonding layer, further preventing delamination.

[0203] In some embodiments, although isolated from direct contact from the interior region 150, the PCB is nevertheless configured to collect and / or distribute information (such as temperature, humidity, flow rate of gas, etc.) about the interior region 150 of the passageway. In some embodiments, the PCB is configured to conduct electricity. In some embodiments, as shown, the encapsulated PCB 101 has portions (e.g., portions of the PCB external to the gas flow path) that are not covered by the molding material so that contact with the PCB (e.g., with wires / conductors, etc.) can be made. In some embodiments, the molding material provides substantially complete or complete physical separation of the PCB from the interior region of the gas flow path (e.g., such that the passageway and the PCB are not in gas communication). In some embodiments, at least one electrical contact of the PCB is not encapsulated and / or covered by the molding material.

[0204] Other embodiments (e.g., as shown in Figures 4C, 4D, 8A, 8B, 9A, and 9B) may comprise a molding member including a molding material that encapsulates the PCB (or substrate), as disclosed above. In some embodiments, the PCB (or substrate) may be fully encapsulated, e.g., any conductive portions (e.g., conductive tracks or electrical contacts) are covered or substantially covered by the molding material. For example, the electrical contacts may include wires that protrude from the molding material, but the contacts themselves are covered by the molding material. In some embodiments, the PCB (or substrate) may be encapsulated such that it is not directly exposed to the gas flow (e.g., the environment of the gas flow path) of the respiratory or medical air delivery system, as disclosed elsewhere herein. In some embodiments, the molding material physically isolates the PCB from the gas flow path. In some embodiments, the molding material forms a barrier between the PCB and the gas flow path. In some embodiments, the molding material encapsulates the PCB such that it physically isolates the PCB from an area outside the gas flow path. In some embodiments, the molding material forms a barrier between the PCB and the exterior region of the gas flow path. In some embodiments, the integrated humidification system of FIG. 16A can include a partially or fully encapsulated PCB or substrate as disclosed elsewhere herein.

[0205] The molded elbow 100 depicted in Figures 2A, 2B, 3A and 3B may also be any portion of a pipe or gas flow path with the PCB 101 penetrating, embedded in, enclosed within or attached to a wall.

[0206] 4A and 4B show another example of a molding member, in this case a molding chamber 200 to which a PCB 201 is attached. A covalent bond is formed at the interface 202 between the molding chamber 200 and the PCB 201. The PCB 201 can be configured to include a heating element to heat a liquid, or more specifically water. The PCB 201 can extend across the bottom of the chamber or partially across the base of the chamber. In some embodiments, the PCB 201 can also include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. In some embodiments, the PCB 201 is configured to be a heater plate and can further include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. The portion of the PCB 201 outside the chamber can provide an electrical connection to a breathing apparatus or other components.

[0207] 4C and 4D show another example of a molded member, in this case a molded chamber 200 with a chamber base molding 204 molded on a PCB 201. The PCB 201 is partially embedded in the chamber base molding 204. As shown, the interface 202 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molded member here, a covalent bond is formed at the interface 202 between the PCB 201 and the molding material 203 of the chamber base molding 204. The chamber base molding 204 can be configured to couple with the molded chamber 200 and, optionally, an O-ring or seal 206 between the chamber base 204 and the molded chamber 200. The PCB 201 can be configured to include a heating element to heat a liquid, or more specifically, water. The PCB 201 can extend completely across the chamber base molding 204 or partially across the chamber base molding 204. In some embodiments, the PCB 201 may also include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. In some embodiments, the PCB 201 is configured to be a heater plate and may further include one or more sensors, such as a humidity sensor, a temperature sensor, or a flow sensor. A portion of the PCB 201 outside the chamber may provide electrical connections to the breathing apparatus or other components. In some embodiments, the PCB 201 may be embedded in the molding chamber 200 by injection molding the chamber around the PCB 201.

[0208] 5A and 5B show an example of another molding member, in this case a molding chamber 200 with a PCB 201 integrated into the inlet and outlet. The PCB 201 is inserted into and through the walls of the inlet and outlet, with portions of the PCB 201 exposed to the interior of the chamber 200 at the inlet and outlet (i.e., not covered by the molding material). Other portions of the PCB 201 are outside the chamber and may be configured to provide electrical connections to a breathing apparatus or other components. The PCB 201 may be integrated into the molding chamber 200 by injection molding the chamber around the PCB 201. The PCB 201 may include one or more sensors, such as a humidity sensor, a temperature sensor, a pressure sensor, a flow sensor, or a liquid level sensor. As shown, the interface 202 may include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molding member here, a covalent bond is formed at the interface 202 between the PCB 201 and the molding material 203 of the chamber 200.

[0209] 6A and 6B show another example of a molding member, in this case a molding chamber 200 with a PCB 201 integrated into the sidewall. The PCB 201 can also be integrated into the wall of the molding chamber 200 elsewhere. The PCB 201 is inserted into and through the wall of the chamber body, with a portion of the PCB 201 exposed to the interior of the chamber 200 (e.g., not covered by an injection, insert or overmolding material). Another portion of the PCB 201 is outside the chamber and can be configured to provide electrical connections to a breathing apparatus or other components. The PCB 201 can be integrated into the molding chamber 200 by injection molding the chamber around the PCB 201. The PCB 201 can include a humidity sensor, a temperature sensor, a pressure sensor, a flow sensor or a liquid level sensor. As shown, the interface 202 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, such as in the molded member herein, a covalent bond is formed at the interface 202 between the PCB 201 and the molding material 203 of the chamber 200.

[0210] 7A and 7B show another example of a molding member, in this case a molding chamber 200 with a PCB 201 integrated into the inlet and outlet. As shown, in some embodiments, the PCB 201 is inserted into and through the walls of the inlet and outlet, with a portion of the PCB 201 exposed to the interior of the chamber 200 (i.e., not covered by the molding material). Other portions of the PCB 201 are outside the chamber and may be configured to provide electrical connections to a breathing apparatus or other components. The PCB 201 may be integrated into the molding chamber 200 by injection molding the chamber around the PCB 201. The PCB 201 may be configured as a humidity sensor, a temperature sensor, a pressure sensor, a fluid level sensor, or a flow rate sensor at each of the inlet and outlet. In some embodiments, the PCB 201 may also be used as a liquid level sensor, for example, having an elongated portion or protrusion 205 that extends to a lower portion of the chamber 200. As shown, the interface 202 may include a bonding layer. In some embodiments, one or more of the bonding layers include a silicon-containing linker. In some embodiments, such as in the molded member herein, a covalent bond is formed at the interface 202 between the PCB 201 and the molding material 203 of the chamber 200.

[0211] 8A and 8B show another embodiment of a molded member, in this case a molded tube connector 300. As shown, in some embodiments, a PCB 301 is encapsulated and positioned within the molded tube connector 300, which can be connected to a breathing tube 305. In some embodiments, as shown, the PCB 301 is substantially completely covered and protected by the molding material 303. As shown, the interface 302 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molded member here, a covalent bond is formed at the interface 202 between the PCB 301 and the molding material 303 that encapsulates the PCB 301. The PCB 301 can be integrated into the connector 300 by injection molding the connector 300 around the PCB 301. The PCB 301 can also include a humidity sensor, a temperature sensor, a pressure sensor, or a flow sensor. In some embodiments, the PCB 301 can also include a tag, such as an RFID, an EPROM, or a resistor, to allow for identification. In some embodiments, the PCB 301 may also be positioned within an inhalation tube, an interface tube, or any tube or connector that is part of the respiratory device. In some embodiments, the PCB includes one or more electrical components, such as a processor, a controller, an identifier, a memory component, a sensor, etc. In some embodiments, the PCB may receive, transmit, and / or process information. Information may be transmitted and received wirelessly.

[0212] 9A and 9B show another embodiment of a molded tube connector 300. A PCB 301 is partially encapsulated and positioned in the molded tube connector 300 that connects to a breathing tube 305. A portion of the PCB 301 is attached and bonded to the molding material 303. As shown, the interface 102 can include a bonding layer. In some embodiments, the bonding layer includes a silicon-containing linker. In some embodiments, as in the molded member here, a covalent bond is formed at the interface 302 between the PCB 301 and the molding material 303. The PCB 301 can be integrated into the connector 300 by injection molding the connector 300 around the PCB 301. A portion of the PCB 301 is directly exposed to the gas flow (i.e., not covered by the molding material). The PCB 301 can include a humidity sensor, a temperature sensor, a pressure sensor, or a flow sensor. In some embodiments, the PCB 301 can also include a tag, such as an RFID, an EPROM, or a resistor, to allow for identification. In some embodiments, the PCB 301 may also be positioned within an intake tube, an interface tube, or any tube or connector that is part of the respiratory device.

[0213] FIG. 10A shows an embodiment of a heater 400 for a humidifier, optionally including a water injection system. FIG. 10B is a cross-sectional view of a portion of the heater 400 comprising a flexible PCB. A molding material 405 is injection molded around a portion of the flexible PCB 401 and adhered thereto through a bonding layer (e.g., by a silane bond). In some embodiments, the bonding layer comprises a silicon-containing linker. A portion of the PCB 401 can be configured to include a heating element, and the portion not overmolded (or covered by the molding material) serves as a connector to the respiratory device or other components. In some embodiments, as here, a covalent bond is formed at the interface 407 between the PCB 401 and the molding material 405. The flexible heating element can be configured to have a helical form or shape, allowing air / gas to pass through the helix while being acted upon by the heating element. The molding material 405 further comprises microchannels 406 on the surface exposed to the air / gas flow. In embodiments with a water injection system, water may flow onto the heating element through inlet port 404 and be distributed along microchannels 406 to the shaped flexible heating element. The water may then vaporize from the heated shaped surface and mix with the air / gas flow. Microchannels 406 run along a spiral in the embodiment shown in Figure 10A, but may run in any direction or follow other patterns.

[0214] FIG. 11 shows another embodiment of a heater 400 for a humidifier, optionally including a water injection system 404. FIG. 10B also shows a cross-sectional view of the heater shown in FIG. 11. A molding material 405 is molded around a portion of a flexible PCB 401 and adhered thereto by a silane bond. A portion of the PCB 401 can be configured to include a heating element, with the portion not covered by the molding material serving as a connector to a breathing device or other component. In some embodiments, as here, a covalent bond is formed at the interface 407 between the PCB 401 and the molding material 405. The flexible heating element can be configured to have a helical form or shape, such that air / gas can pass through the helix while being acted upon by the heating element. The molding material 405 further includes microchannels 406 on the surface exposed to the air / gas flow. In an embodiment with a water injection system, water can flow over the heating element via the inlet port 404 and be distributed along the microchannels 406 to the molded flexible heating element. The water can then be vaporized from the hot mold material surface and mixed with the air / gas flow. The microchannels 406 run perpendicular to the helix in the embodiment shown in Figure 11. However, the microchannels 406 can run in other directions or follow other patterns.

[0215] FIG. 12A shows one embodiment of a heater 500 for a humidifier, optionally including a water injection system 504. FIG. 12B is a cross-sectional view of a portion of the heater 500 comprising a PCB 501. A molding material 505 is molded around a portion of the flexible PCB 501 and is bonded thereto through a bonding layer (e.g., by a silane bond). A portion of the PCB 501 can be configured to include a heating element, and the portion not covered by the molding material serves as a connector to a breathing device or other components. In some embodiments, as here, a covalent bond is formed at the interface 507 between the PCB 501 and the molding material 505. The flexible heating element can be formed in a corrugated pattern, and air / gas can flow past the molding material surface in the same direction of the corrugations while being acted upon by the heating element. The molding material 505 further comprises microchannels 506 on the surface exposed to the air / gas flow. In embodiments with a water injection system, water can flow onto the heating element through inlet port 504 and be distributed along microchannels 506 to the molded flexible heating element. The water can then be vaporized from the hot molded material surface and mixed with the air / gas flow. In the embodiment shown in Figure 12A, the microchannels 506 run in the same direction as the corrugations. In other embodiments, the microchannels 506 can run in other directions or follow other patterns.

[0216] FIG. 13A shows yet another embodiment of a heater 500 for a humidifier, optionally including a water injection system. FIG. 13B also shows a cross-sectional view of the heater shown in FIG. 13A. A molding material 505 is molded around a portion of a flexible PCB 501 and is bonded thereto through a bonding layer (e.g., by a silane bond). A portion of the PCB 501 can be configured to include a heating element, and the portion not covered by the molding material serves as a connector to a breathing device or other component. In some embodiments, as here, a covalent bond is formed at the interface between the PCB 501 and the molding material 505. The flexible heating element can be formed in a corrugated pattern, and air / gas can flow through the molding material surface in the same direction of the corrugations while being acted upon by the heating element. The molding material further includes microchannels 506 on the surface exposed to the air / gas flow. In an embodiment with a water injection system, water can flow over the heating element through the inlet port 504 and be distributed along the microchannels 506 to the molded flexible heating element. The water can then be vaporized from the hot mold material surface and mixed with the air / gas flow. The microchannels 506 run perpendicular to the corrugations as shown in Figure 13A, but can run in any direction or follow other patterns.

[0217] Molded elbows, tubes, chambers, inlets, outlets, walls, tube connectors, heaters, water injection systems, and combinations thereof can be included in the air and gas humidification system. These components can comprise molded materials and can be molded members comprising PCBs (or substrates) bonded together via bonding layers as disclosed elsewhere herein. These components, or other molded members as disclosed elsewhere herein, can be part of a humidification circuit and / or system. Additionally, the humidification circuit and / or system can be part or component of a breathing system, an insufflation system, and / or other gas delivery system that provides heated, humidified gas to a patient. In some embodiments, an insufflation system can be used to provide heated and / or humidified gas to a patient's body cavity (e.g., to the abdomen) before, during, or after a surgical procedure. By way of example, insufflation gas can be used for various purposes during a surgical procedure. In open surgery, such as in cardiac surgery, gas can be insufflated into a body cavity for degassing. In laparoscopic surgery, gas can be used to expand the abdominal wall to provide a location for instrument insertion and tissue incision. During these surgical procedures, it may be desirable to introduce insufflation gases into the surgical cavity under controlled operating parameters, such as specific flow rates, pressures, temperatures, or humidity.

[0218] In some embodiments, the humidification system comprises a heating system comprising one or more molding members as disclosed elsewhere herein. In some embodiments, the heating system comprises a heating surface configured to receive a controlled flow of liquid and humidify gas passing through the humidification system. In some embodiments, the heating surface comprises a portion of a molding member as disclosed elsewhere herein. In some embodiments, one or more molding members (as disclosed elsewhere herein) of the system are provided with one or more temperature sensors that measure the surface temperature of the heating surface. The temperature sensor (and / or any other sensor disclosed herein, such as a flow sensor, humidity sensor, etc.) can comprise a substrate (e.g., a PCB) having one or more sensing regions bonded to the molding material as described elsewhere herein.

[0219] In some embodiments, the humidification system disclosed herein may comprise one or more sensors in electronic communication with one or more of the liquid flow controllers providing a controlled flow of liquid, namely: one or more hardware processors for deterministically controlling the humidity level of the gas passing through the breathing system by instructing the liquid flow controller to adjust the controlled flow rate of the liquid received in the heating system, instructing the heating system to adjust the surface temperature of the heated surface (which is controlled to create a known vaporization area by adjusting the surface temperature of the heated surface), and one or more liquid sensors configured to detect whether the heated surface is wetted in at least one area. In some embodiments, the one or more liquid sensors may be at least two liquid sensors configured to detect whether the heated surface is wetted in two or more areas of the heated surface. The at least two liquid sensors may be two temperature sensors. The one or more liquid sensors may be located on, on, adjacent to, or in close proximity to the heated surface, and in some embodiments may be part of the same molded member, as disclosed elsewhere herein. In some embodiments, the liquid may be water.

[0220] In some embodiments, the disclosed shaped members and parts or portions thereof (disclosed elsewhere herein) can be configured to receive water and / or distribute water over the heating element. The heating element is in fluid communication with the gas channel as needed, as opposed to heating the entire supply fluid at once or heating an otherwise excessive volume of liquid, such as a chamber of liquid. In some embodiments, by measuring the inlet gas flow rate, inlet gas dew point temperature and / or gas channel pressure level, the fluid flow rate of the liquid to the heating surface can be determined and controlled to achieve a desired output humidity and temperature level (or outlet dew point temperature) of the gas to be delivered to the patient. In some embodiments, where the controller is in electronic communication with one or more sensors, the controller can automatically adjust one or more parameters of the gas, such as increasing or decreasing the humidity and / or temperature.

[0221] 14A, a non-limiting exemplary configuration of a respiratory therapy system 600 is shown. In the illustrated configuration, the respiratory therapy system 600 includes a flow generator 620. The flow generator 620 may have, for example, a blower 621 adapted to force gas through the respiratory therapy system 600. The gas forced using the blower 621 may include, for example, air received from an environment external to the respiratory therapy system 600 (e.g., "ambient air" or "ambient gas") and / or gas (e.g., oxygen, nitrogen, CO2, etc.) from a gas container (e.g., see gas reservoir 637 in FIG. 14C) in communication with the respiratory therapy system 600. The gas from the flow generator 620 is directed to and / or through a respiratory humidification system 601 adapted to add moisture to the gas. The respiratory humidification system 601 includes a gas channel 602 (sometimes referred to herein as a "breathing tube" or "inhalation tube") adapted to receive gas from a flow generator 620 and / or another gas source and direct the gas to an outlet, such as a patient interface 622. As shown at the top of FIG. 14 (U→D), in use, gas may travel generally in a downstream direction from the flow generator 620 to the respiratory humidification system 601 (e.g., through the gas channel 602) and from the respiratory humidification system 601 to an outlet or patient interface 622 (e.g., through the gas channel 602). In some embodiments, the patient interface may include a mask, a nose fitting, an esophageal tracheal airway tube, or the like. The patient interface may be of the sealed or non-sealing type. For embodiments providing a respiratory gas delivery system, as disclosed elsewhere herein, the patient interface may include any suitable interface, including, but not limited to, a nasal cannula (e.g., including manifolds, nasal prongs, etc.), a face mask, a nasal pillow mask, a nasal mask, and / or a tracheostomy interface. In some embodiments where a portion of the respiratory humidification system comprises a molded member (e.g., a wall, a tube, a chamber, etc., having one or more PCBs), the molding material may be bonded to a substrate of the molded member via a bonding layer.

[0222] With further reference to the non-limiting exemplary configuration shown in FIG. 14A, the respiratory humidification system 601 includes a fluid reservoir 606 that contains a fluid during use. "Fluid" in this context may refer to a liquid or a flowable solid that is suitable for humidifying respiratory gas, and may include, for example, water. The fluid may be water with an additive that is more volatile than water. The fluid reservoir 606 is fluidly or otherwise physically coupled to a metering device (also referred to herein as a liquid flow controller or a water flow controller) 610. The metering device 610 is configured to meter fluid from the fluid reservoir 606 to a humidification housing 615 located within the gas channel 602 or outside of but in pneumatic communication with the gas channel 602. The metering device 610 may further include a pump. The pump may be, for example, a positive displacement pump, such as a piezoelectric diaphragm pump, a peristaltic pump, a micron pump, or a progressive cavity pump. The pump may also be a pressure-fed device, such as a gravity-fed device in series with a control valve. The metering device may include a wicking structure that employs capillary action to controllably meter water to the wicking element and / or to the heated surface.

[0223] The metering device 610 can be controlled by a water flow controller. The water flow controller can be a pump in an open loop configuration. The water flow controller can be a pump or flow actuator in series with a flow sensor in a closed loop configuration. The water flow controller can provide a continuous flow of water at a value equal to or at least about 0 mL / min, 1 mL / min, 2 mL / min, 5 mL / min, 10 mL / min, or a range including and / or spanning the values ​​set forth above (e.g., a range of 2 mL / min to 10 mL / min, a range of 0 mL / min to 5 mL / min, etc.). The water flow controller can provide a flow rate of water with an accuracy of about ±1%, ±2.5%, ±5%, ±10%±15%, or a range including and / or spanning the values ​​set forth above.

[0224] The water flow controller, including the metering system 610, can be configured (e.g., can be in electronic communication with the heating element) to ensure that the surface of the heating element 614 is fully wetted (saturated). A fully wetted surface can improve humidity control. A wetted surface also means that humidity can increase more quickly because water moves more quickly over a wet surface than over a dry surface.

[0225] Any positive displacement pump can be used in the water controller or metering device 610. A positive displacement pump works by dispensing a fixed amount of water and generally provides good accuracy. Any of a variety of positive displacement pumps are suitable, e.g., peristaltic, diaphragm, vane, plunger, etc., most of which can be adjusted to work at the flow rates contemplated herein. However, piezoelectric micropumps (miniature diaphragm pumps using piezoelectric elements as actuators) and peristaltic pumps (using rollers to squeeze water through tubes at a fixed flow rate) may be particularly advantageous, as many are already commercially available in sizes, prices, operating ranges, and powers that are suitable for the systems described herein. Additionally, pumps can be replaced by pumping devices, such as gravity feed devices in series with control valves (see FIG. 14D), and / or wicking / capillary action. In some configurations, electronic / magnetic-hydrodynamic pumps can be used.

[0226] If the water flow controller includes a flow sensor, in some configurations, the flow sensor can be a thermal mass flow meter. The flow sensor can be provided as a PCB including a molding compound bonded to a substrate (e.g., PCB) as disclosed elsewhere herein. These sensors work by heating the liquid and measuring the power required to heat it (e.g., heated flow beads) or an induced temperature gradient, or any variation thereto. Alternatively, the flow sensor can be replaced or supplemented by a dripping device (which counts droplets, as is the common way to measure flow in an IV), a differential pressure sensor to measure the pressure drop across a constriction to calculate the flow rate, and / or a volumetric sensor that senses the flow rate using the same principles as a volumetric pump.

[0227] The fluid reservoir 606 can be connected to the metering device 610 via a first fluid conduit 608 as shown. The first conduit 608 can have a check valve configured to maintain the metering device in a primed state. The first conduit 608 can also have a check valve configured to maintain the pump in a primed state. The first conduit 608 can also have a safety valve, such as a pressure relief valve, in the conduit leading to the metering device to prevent liquid flow in the event of a pump or water controller failure. The respiratory humidification system 601 can also have a flow restriction device positioned between the reservoir 606 and the metering device 610 to prevent gravity-driven flow from affecting the water flow path. The flow restriction device can be an elastic protrusion that squeezes or otherwise restricts the flow path. The metering device 610 meters the fluid through a second fluid conduit 612 to the humidification housing 615. In some embodiments, the metered fluid can enter the humidification housing 615 through an inlet 616 to the humidification housing 615. The first conduit and / or the second conduit can comprise or be a molding member as disclosed elsewhere herein, for example, comprising one or more substrates (e.g., having sensors, heating tracks, etc.) coupled to a molding material.

[0228] A heating device or heater 614 may be present within (as part of a molded member bonded as disclosed elsewhere herein), at or near the humidification housing 615. The heater 614 may have a wicking element configured to distribute fluid dispensed to the heater 614. The wicking element may be part of a molded material (e.g., bonded to a substrate as disclosed elsewhere herein) formed in a shape that conforms to a mold. In some configurations, the wicking element is configured to wick the dispensed fluid evenly across a surface of the heating device 614. The heater 614 may be configured to vaporize the dispensed fluid so that it is mixed into the gas flow by the respiratory therapy system 600 in use. The heater 614 may be configured to maintain a heated surface at a temperature range. The temperature of the heated surface through the molding material can be up to about 30° C., 35° C., 40° C., 45° C., 50° C., 60° C., 70° C., 80° C., 90° C., 99.9° C., and / or ranges including and / or spanning these temperatures. In some embodiments, the molded heated surfaces disclosed herein can be heated to temperatures in excess of 100° C. for weeks, months, or even years without substantial delamination, unlike conventional heated surfaces.

[0229] The heating surface may include a heating element configured to provide heat to the heating surface. As disclosed elsewhere herein, the heating surface and / or heating element may be part of a PCB that is bonded to the molding material via a bonding layer. The heating element may be a circuit board (e.g., a PCB disclosed elsewhere herein). The circuit board may be a printed circuit board (e.g., as shown and described below with respect to Figures 16A-16C). The circuit board (e.g., a PCB) may include, among others, a resistive element (e.g., a trace or tracking), an etched foil film, a heating coil, or a PTC element. The circuit board may be a flexible circuit board. The flexible circuit board may be made of aluminum-polyimide. The circuit board may have a plurality of resistive tracks. The resistive tracks may be copper. The heating element may be an etched foil (e.g., as shown and described below with respect to Figures 16D and 16E). The heating element may be a heating wire bonded to the substrate via a bonding layer as disclosed elsewhere herein and molded and coupled to the molding material. The heating wire can be Nichrome. The heating element can be a Positive Temperature Coefficient (PTC) ceramic. The PTC ceramic can be Barium Titanate. The heating element can be a thermoelectric element. The thermoelectric element can be a Peltier element.

[0230] As disclosed elsewhere herein, the wicking surface can be provided by molding material on a circuit board, molding material having microchannels, and molding material bonded to a substrate (e.g., a circuit board) via a bonding layer (e.g., including a silicon-containing linker). The heating surface temperature can be measured, at least in part, by determining the resistance level or other characteristic of the heating element. The resistance level of the heating element can be used to indicate the average temperature of the heating surface. The heating element can be arranged to provide a higher power density to a designated area of ​​the heating element compared to the power density provided to other areas of the heating element (e.g., as described with respect to FIG. 16C). The designated relatively high density area of ​​the heating element can be located at the outlet of the water supply to the heating surface. The designated relatively high density area of ​​the heating element can be located at the water pre-heat area of ​​the heating surface.

[0231] Components of the respiratory therapy system 600 or respiratory humidification system 601 may include a controller 618 that may control the operation of components of the respiratory therapy system 600 or respiratory humidification system 601, including, but not limited to, the flow generator 620, the metering device 610, and / or the heating device 614. The metering device 610 may be configured to meter or allocate fluid to the humidification housing 615 and / or to the heating device 614 at a metering rate that increases the moisture content of the gas passing through the gas channel 602 such that the gas reaches a predetermined, calculated, or estimated humidity level that represents a level of gas humidity required or desired by a patient using the respiratory humidification system 601, while taking care to reduce or eliminate the possibility of excessive moisture accumulation in the gas channel 602. In some embodiments, a controller is provided that may control one or more components in the system. In some embodiments, the controller varies the metering rate of the metering device 610 based on, for example, measured parameters of the system (e.g., a measured flow rate of gas through the gas channel 602, a measured humidity of the gas upstream of the humidification housing 615 or in the gas flow path, a measured pressure level corresponding to a pressure level in the gas channel 602, etc.). In some configurations, the control of the water flow rate to the heated surface by the controller can be based on the flow rate of gas in the gas channel. The control of the water flow rate to the heated surface can be based on the evaporation rate of water from the heated surface. The control of the water flow rate to the heated surface can be based on the temperature of the heated surface, where the temperature of the heated surface is maintained at a constant temperature. More information regarding controllers (including deterministic controllers) can be found in International Application PCT / NZ2015 / 050128, published as WO 2016 / 036260, which is incorporated herein by reference in its entirety.

[0232] Advantageously, the molding members disclosed herein can extend the life of a system (e.g., a breathing system and / or an air delivery system) by substantially preventing or delaying delamination of one or more molding members of the system. In some aspects, preventing and / or substantially delaying delamination prevents or reduces sensor corrosion, gas pressure leakage, and / or humidity loss resulting from delamination. In some embodiments, delamination is prevented altogether over the life of the device or a part thereof. In other cases, the bonding layers disclosed herein (e.g., bonding layers including covalent bonds and / or silicon-containing linkers) extend the life of the device or a part thereof (e.g., by delaying delamination, etc.) by about 2-fold, 4-fold, 6-fold, 10-fold, 20-fold, 50-fold, 100-fold, or more than a range including or spanning the values ​​set forth above.

[0233] In some embodiments, as shown, the first fluid conduit 608 and the second fluid conduit 612 can be configured to fluidly communicate the various components of the respiratory humidification system 601. As shown in FIG. 14A, the first fluid conduit 608 can be configured to fluidly communicate the fluid from the fluid reservoir 606 to the metering device 610, and the second fluid conduit 612 can be configured to fluidly communicate the fluid from the metering device 610 to the humidification housing 615. In some configurations, the first fluid conduit 608 and / or the second fluid conduit 612 are optional. For example, if the fluid reservoir 606 is in direct fluid communication with the metering device 610, the first fluid conduit 608 need not be present. Similarly, if the metering device 610 is in direct fluid communication with the humidification region 615, the second fluid conduit 612 need not be present.

[0234] As shown in FIG. 14C, the first fluid conduit 608 and / or the second fluid conduit 612 may further comprise one or more filters 628 configured to remove contaminants, impurities or other undesirable substances from the fluid coming from the fluid reservoir 606. In some embodiments, the housing for the filter is or comprises a shaped member as disclosed elsewhere herein. In some implementations, the filter 628 may comprise any structure, including a permeable or semi-permeable membrane, positioned in the fluid flow path of the first conduit 608 and / or the second conduit 612 configured to do so and / or configured for use in microfiltration, ultrafiltration or reverse osmosis. The presence of one or more filters 628 in the first conduit 608 and / or the second conduit 612 may help reassure a user of the respiratory humidification system 601 that the quality of the fluid introduced into the humidification housing 615 is at an acceptable level. If one or more of the filters 628 have been used for too long, the filter 628 may be replaced. In some embodiments, the first conduit 608 and / or the second conduit 612 may also be replaced (e.g., if contaminated). Advantageously, however, due to the robust nature of the molded members disclosed herein, in some embodiments, a cleaning cycle with a germicide and / or at a germicidal temperature (e.g., 100° C. or higher) may be performed without damaging the structure of the breathing system or its components. In some implementations where the filter is replaced, the molded housing for the filter remains intact for continued use. The life of the filter 628 may be indicated to the user, for example, through a chemical color change indicator located in or on the first conduit 608 and / or the second conduit 612, or the filter 628 may change color over time due to prolonged exposure to gases and / or fluids. The filter 218 may act as a reserve distributor of humidification liquid.

[0235] As discussed above, the metering device 610 may serve to meter fluid from the fluid reservoir 606 to the humidification housing 615. The metering device 610 may include, for example, a fluid displacement pump that may actively transport fluid from the fluid reservoir 606 to the humidification housing 615, for example along the first conduit 608 and / or the second conduit 612. In some embodiments, the metering device 610 may operate in reverse or act to draw fluid from the humidification housing 615. The fluid displacement pump may include, for example, a positive displacement pump, such as a piezoelectric diaphragm pump, a peristaltic pump, a micropump, or a progressive cavity pump.

[0236] As shown in Figure 14B, the system can be embodied as an in-line humidifier. In this embodiment, the humidification system 601 can be an extension to the breathing circuit used in any flow-generating system, or it can be a stand-alone humidifier that uses ambient air and relies on normal patient breathing to generate the gas flow.

[0237] In some embodiments not shown, the heating device 614 can be positioned outside of the gas channel 602. For example, the heating device 614 can be in a separate compartment. In some embodiments, the compartment is or includes a shaped member as disclosed elsewhere herein. The compartment can be physically coupled to the gas channel 602, but can be fluidically isolated from the gas channel 602. The compartment 624 can be fluidically isolated from the gas channel 602 by using a semi-permeable membrane positioned between the compartment and the gas channel 602. In some implementations, the membrane is connected to the system through a housing. In some configurations, the semi-permeable membrane can prevent fluid from passing through, but allow the vaporized fluid to pass through (so that the vaporized fluid can merge with the gas passing through the gas channel 602). Examples of suitable materials for use with the semipermeable membrane include perfluorinated polymers or polymers having micropores, including materials such as those used in the tubing described in commonly owned U.S. Patent No. 6,769,431, filed May 8, 2001, entitled "Expiratory Limit for a Breathing Circuit," and U.S. Patent Application No. 13 / 517,925, filed December 22, 2010, entitled "Components for Medical Circuits," both of which are incorporated herein by reference in their entireties. In use, fluid may be metered into the compartment through the outlet 616, vaporized using a heating device 614 (which may be further positioned within the compartment), and forced through the semipermeable membrane to interact with gas moving downstream through the gas channel 602. Fluidically isolating the outlet 616 from the gas channel 602 may reduce the likelihood of liquid water being present in the gas channel 602, for example.

[0238] It should be understood that the metering device 610 does not necessarily include a pump, but may simply include a structure configured to allocate fluid to the humidification housing 615 in a predetermined, desired, or regulated amount. For example, in some embodiments not shown, the fluid reservoir 606 can be suspended vertically above the gas channel 602 and / or the humidification housing 615. The fluid reservoir 606 can be in communication with an electromechanical valve that can be partially or fully opened or closed to control the passage of fluid from the fluid reservoir 606 through the second fluid conduit 612 to the humidification housing 615 in response to a signal generated by the controller 618. In some implementations, the fluid reservoir can include one or more sensors molded into the reservoir (e.g., on one or more PCBs). In some implementations, the fluid reservoir is or includes a molded member having one or more sensors in communication with the contents of the reservoir via a bonding layer as disclosed elsewhere herein.

[0239] In some configurations, the second fluid conduit 612 may not be present and the fluid reservoir 606 may cooperate with the electromechanical valve to transport fluid directly to the humidification region 615 (and / or to a location at or near the heating device 614). Fluid flow sensors, such as, but not limited to, microelectromechanical systems or MEMS sensors, may be used to determine the fluid flow rate through the electromechanical valve or the second fluid conduit 612. In some embodiments, these sensors are PCB sensors that may be molded into the system via bonding layers as disclosed elsewhere herein. Signals from the fluid flow sensors or values ​​derived therefrom may be used to control the operation of the electromechanical valve, for example, via closed loop control. In some implementations, the fluid reservoir 606 may be vertically above the gas channel 602, although in some configurations, the fluid reservoir 606 may be at the same level as the gas channel 602 or at a lower level than the gas channel 602. Other forces may act on the fluid reservoir 606 to meter fluid in combination with the electromechanical valve. For example, the respiratory humidification system 601 may be configured such that fluid is forced out of the reservoir 606 using the force of gas passing through the respiratory therapy system 600 and / or the respiratory humidification system 601. In some configurations, the gas may act directly on the fluid in the fluid reservoir 606. In some configurations, the fluid reservoir 606 may be pressurized by a fluid-filled pouch (e.g., filled with gas from the gas generator 620 or from a separate gas source) that forces fluid out of the fluid reservoir 606. The pressure exerted by the pouch may be controlled using a biasing force generated, for example, by a spring or other mechanical configuration.

[0240] In some embodiments, the heating device 614 can be configured to transfer heat to a fluid metered on or near the heating device 614 to promote vaporization of the fluid and entrainment into the gas flow passing through the gas channel 602. As disclosed elsewhere herein, the particular form of the heating device 614 is not limited, and many different heating devices can be envisioned for use with the respiratory humidification system 601 (or air delivery system, etc.). In some configurations, the heating device 614 can include a molded member (disclosed elsewhere herein) with a heating surface or element that can be resistively heated upon application of electrical energy. The resistive heating plate can be constructed from a conductive metallic material, but can also be made from a conductive plastic.

[0241] The controller 618 may include a microprocessor or some other architecture configured to direct the operation of the controllable components of the system 600, 601. In some implementations, these microprocessors or other architectures communicate (e.g., electronically communicate) with sensors or features that are part of the molded member (e.g., sensors on a PCB that connects to components of the system and is coupled to the molded material via a bonding layer, as disclosed elsewhere herein). In some configurations, one controller 618 may control the operation of all controllable components of the respiratory therapy system 600 and / or respiratory humidification system 601 (or other humidification systems), including, but not limited to, the metering device 610, the heating device 614, and / or the flow generator 620. The controller 618 may be physically present in, on, or near components of the respiratory therapy system 600, including, but not limited to, the flow generator 620, the respiratory humidification system 601, the housing 603, and / or the gas channel 602. In some configurations, the controller 618 may be physically separate from the respiratory therapy system 600. For example, the controller 618 can be located on a remote computer, tablet, cell phone, smart watch, or another device, and the controller 618 can remotely direct the operation of the controllable components of the respiratory therapy system 600. In some configurations, multiple controllers can be used to control the controllable components of the respiratory therapy system 600 and / or the respiratory humidification system 601. The multiple controllers can each be directed to exclusive control of one or more controllable components of one or both of the systems 600, 601. In some configurations, control of one or more controllable components of one or both of the systems 600, 601 can be handled by multiple controllers. The multiple controllers can be configured to communicate with each other.

[0242] As shown in FIG. 14C, a flow sensor may be present. A gas flow sensor 634 (see FIG. 14C) positioned within the gas channel 602 may generate a flow signal representative of the flow rate of gas passing through the gas channel 602. The signal generated by the gas flow sensor 634 may be processed and converted into a gas flow value. The flow sensor may be part of a molded member as disclosed elsewhere herein. A humidity sensor 636 (e.g., as shown in FIG. 14C) positioned upstream of the humidification housing 615 or external to the respiratory therapy system 600 may generate a humidity signal representative of the relative or absolute humidity of the gas upstream of the humidification housing 615 or of the ambient gas external to the respiratory therapy system 600. The signal generated by the humidity sensor 636 may be processed and converted into a humidity value.

[0243] Various sensor modules may also be positioned downstream of the humidification housing 615 within the gas channel 602. As discussed in FIG. 14C, the sensor modules may include, for example, a flow sensor 638, a humidity sensor 640 (including, for example, an absolute humidity sensor and / or a relative humidity sensor), a temperature sensor 641, and / or a pressure sensor 642. Each of these sensors may be bonded individually or collectively via a bonding layer to a molding material that provides a part of the system. For example, a molding member (disclosed elsewhere herein) may be part of the wall of the channel 602. One or more sensors may be provided on the molding member. One or more of these sensors may be used by the controller 618 to facilitate control of components of the respiratory therapy system 600 and / or respiratory humidification system 601, including control of the operation of the gas flow generator 620 (including, for example, the motor speed of the blower 621), the heat output of the heating device 614, the metering rate of the metering device 610, and / or any other components.

[0244] Also, as demonstrated in FIG. 14C, a gas concentration sensor 635 (which may be bonded to components of the system via a bonding layer) may be positioned within the gas channel 602. The gas concentration sensor 635 may be configured to sense the concentration of one or more gases in the gas stream. The gas concentration sensor 635 may include, for example, an ultrasonic sensor adapted to sense oxygen. The detected gases may include, for example, oxygen, nitric oxide, carbon dioxide, and / or heliox, which are introduced into the gas channel 602 from a gas reservoir 637 through a gas concentration regulator valve 639. The gas concentration sensor 635 may use the gas concentration signal generated by the gas concentration sensor 635 to control (e.g., via closed loop control) the gas concentration regulator valve 639 based on a predetermined desired gas concentration (e.g., input by a user via the user interface 605).

[0245] In some configurations, as demonstrated in FIG. 14C , a fluid sensor 617 can be in communication with the humidification housing 615 and / or the heating device 614 as a safety measure to help avoid scalding the patient with superheated gases. Illustratively, the fluid sensor 617 can be configured to generate a signal upon detecting the presence of fluid in the humidification housing 615 and / or in or on the heating device 614. The controller 618 can use the signal emitted by the fluid sensor 617 to control the operation of the metering device 610 and / or the operation of the heating device 614. For example, the metering rate of the metering device 610 and / or the heat output of the heating device 614 can be set as a function of the signal generated by the fluid sensor 617. If the signal does not indicate the presence of fluid in or near the humidification housing 615 or in the module area of ​​the heating device because the heating device is intended to be covered with a thin layer of humidification fluid, the metering rate of the metering device 610 can be increased. Similarly, the heat output of the heating device 614 can be reduced or set to zero if the signal does not indicate the presence of fluid in or near the humidification housing 615 or in the module area of ​​the heating device to avoid heating the gas to an unsafe temperature. Thus, the fluid sensor 617 can be used to help control the metering device 610 and / or heating device 614 if it is determined that fluid is not present in the humidification area 615 and / or on the heating surface of the heating device 614 when it would otherwise be expected to be present therein (e.g., if the metering device 610 is attempting to meter fluid at an ascending rate). In some configurations, the respiratory therapy system 600 or components thereof (including the respiratory humidification system 601) can be configured to generate an alarm or communicate a message to the user (e.g., via the user interface 605) when a determination is made to inform the user that they should correct the situation (e.g., by refilling the fluid reservoir 606).

[0246] In some configurations, the fluid sensor 617 may include a capacitive fluid sensor. If a heating surface of the heating device 614 is present, the capacitive fluid sensor may include, for example, a pair of conductive sense electrodes positioned on either side of the heating surface. When the conductive sense electrodes are connected in a circuit and a voltage is applied, the capacitance of the circuit changes in response to the presence or absence of water. The capacitance of the circuit may be measured, for example, using a standard AC measurement circuit. Many other sensing systems may also be used to determine the presence of fluid, including ultrasonic or optical level sensing systems. The capacitive fluid sensor or a portion thereof may be molded in place or bonded to the molding material via a bonding layer.

[0247] To control the various components of the respiratory therapy system 600 and / or respiratory humidification system 601, the controller 618 may utilize various sensor modules. The sensor modules may include one or more sensors that detect various characteristics of the gas in the gas channel 602 or elsewhere in, around, or near the respiratory therapy system 600 (including in or near the gas inlet 623, gas outlet 627, patient interface 622, or in the humidification housing 615, upstream and / or downstream thereof), including pressure, gas flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration, ambient temperature, and / or ambient humidity. One or more of these sensors and / or sensor modules may be used to facilitate, for example, control of the flow generator 620 (including control of the pressure and / or flow rate of the gas pushed downstream by the flow generator 620), control of the heat output of the heating device 614 (including control of the temperature of the heating device), and / or control of the metering rate of the metering device 610 (including control of the power and / or current applied to the metering device 610). These sensors may be molded into the molded member (disclosed elsewhere herein). In some configurations, the respiratory activity of a patient using the respiratory therapy system 600 and / or respiratory humidification system 601 may be determined, estimated, or calculated using one or more of the sensors or sensing modules described above or elsewhere in this disclosure. The controller 618 may control various components of the respiratory therapy system 600 and / or respiratory humidification system 601 such that they operate based on the determined respiratory activity or state.

[0248] In some configurations, the flow generator 620 can include, for example, a source or container of compressed gas (e.g., air, oxygen, etc.). If a container is used, the container can include a valve that can be adjusted to control the flow rate of gas exiting the container. In some configurations, the flow generator 620 can use such a compressed gas source and / or another gas source in place of the blower 621. In some configurations, the flow generator 620 can use such a compressed gas source and / or another gas source in conjunction with the blower 621. The blower 621 can include an electric blower or a bellows configuration, or some other structure adapted to generate a gas flow. In some configurations, the flow generator 620 can draw in atmospheric gas through the gas inlet 623. In some configurations, the flow generator 620 can be adapted to draw in atmospheric gas through the gas inlet 623 as well as accept other gases (e.g., oxygen, nitric oxide, carbon dioxide, etc.) through the same gas inlet 623 or through a different gas inlet (not shown). In some configurations, as demonstrated in FIG. 14B, the flow generator 620 may not be present and the respiratory therapy system 600 can be configured such that only unpressurized ambient air is humidified and directed to the outlet / patient interface 622.

[0249] In some configurations, as demonstrated in FIG. 14C, the respiratory therapy system 600 and / or respiratory humidification system 601 can include an electromagnetic radiation emitter 651 (e.g., positioned within the gas channel 602). The emitter 651 can include an ultraviolet light source (e.g., UV LED), a microwave emitter, or some other radiation emitter configured to sterilize the gas flow path. A means of sterilizing the passageway through which the gas passes through the respiratory therapy system 600 and / or respiratory humidification system 601 can reduce issues of patient infection due to the introduction of unwanted pathogens. The emitter can be provided as a molded member (e.g., the emitter can be part of a PCB that is bonded to the molding material of the system via a bonding layer).

[0250] In some configurations, as discussed in FIG. 14C, the respiratory therapy system 600 and / or respiratory humidification system 601 can include a gas heating region 632. The gas heating region 632 can preheat the gas passing through the gas channel 602 before the gas reaches the humidification housing 615. If the gas is preheated before being humidified, the efficiency of the humidification can be improved. The gas heating region 632 can include, for example, one or more resistive heating wires or heating elements on a PCB that reside in, on, around or near the inner and / or outer walls of the gas channel 602. The gas heating region 632 can be controlled by and in electrical communication with the controller 618, which can use the sensor signal to control the heat output of the gas heating region 632, for example, in a manner similar to the control of the heat output of the heating device 614 described elsewhere in this disclosure. The controller 618 can control the temperature and / or heat output of the gas heating region 632 so that the gas reaches the gas outlet 627, the patient interface 622, or the patient at a temperature of about 31° C. to about 43° C. In some cases, if the gas heating region 632 is further from the gas outlet 627 or the patient interface 622, the gas heating region 632 can heat the gas to a higher temperature of about 37° C. to about 43° C. so that the gas reaches the gas outlet 627, the patient interface 622, or the patient at a desired temperature (due to temperature losses as the gas travels, for example, along the gas channel 602). In some embodiments, the heating device of the gas heating region 632, or a portion thereof, can be molded into the molding material of the system via a bonding layer.

[0251] The gas heating area 632 may include a gas preheater that may include a gas heating element. The gas heating element may be a printed circuit board (as shown in Figures 15A-15C). As disclosed elsewhere herein, the PCB may be part of a molded part and may be molded with a molding material via a bonding layer. The PCB may have a resistive element. The gas heating element may be an etched foil film (see, for example, Figures 15D and 15E). The gas heating element may be a heating coil. The gas heating element may be a PTC ceramic. The respiratory humidification system 600 may have a temperature sensor. The temperature sensor may be positioned downstream of the gas preheater in the gas channel. The temperature sensor may be positioned upstream of the gas preheater in the gas channel instead of or in addition to a temperature sensor positioned downstream of the gas preheater. Characterization of the gas heating element may be used to determine the temperature of the gas. Control of the power level supplied to the gas heating element may be based on information provided by a temperature sensor positioned downstream of the gas preheater in the gas channel. Control of the power level provided to the gas heating element can be based on information provided by a gas flow sensor and by a temperature sensor positioned upstream of the gas preheater in the gas channel. The desired downstream temperature of the gas can be determined based on the evaporation rate of water from the heating surface. As disclosed elsewhere herein, the heating surface can include a heating element configured to provide heat to the heating surface. The heating element can include a plurality of resistive tracks. The heating element can be a printed circuit board. The printed circuit board can have resistive elements. The heating element can be an etched foil film (see Figures 15D and 15E). Similarly, the system can also include preheating the water flow. This can be done by either heating the water source, heating the water supply line, or having special zones on the heater plate (e.g., the water is wicked over the water preheater before reaching the evaporation area, or the initial area has a higher power density). Each of these heat sources can be part of the molded member of the humidification system (e.g., a portion of a PCB bonded to the molding material via a bonding layer).

[0252] The inlet conditioning and testing can include an inlet subsystem at or near the gas supply location, including one or more inlet sensors configured to measure inlet gas ambient humidity, inlet gas flow rate, inlet gas temperature, and pressure levels in the gas channel. An inlet gas heater can also be provided at or near the gas supply location to preheat the gas to a desired (predetermined) temperature as it enters and passes through the gas channel so that it reaches the humidification location at the desired temperature. By preheating the gas separately, energy provided to the heating element in the humidification area can be used to vaporize the humidification fluid, thereby separating the functions of heating the gas in the gas channel (by providing sensible heat from the gas preheater) and humidifying the gas (by providing latent heat from the heating element). Advantageously, this separation of functions allows the heating element to be operated at a lower power level corresponding to a lower temperature level, thereby making the operation of the respiratory humidification system safer and more efficient. Furthermore, the temperature of the heated gas can be changed quickly, such that the system is more responsive to changes than a system that heats the entire fluid reservoir or a significant volume beyond the required volume. The liquid flow controller may include a humidification fluid flow control subsystem that monitors and controls the rate at which fluid is metered to the humidification region, and more specifically to the heating element. A fluid flow sensor measures the flow rate of the humidification fluid and provides measurements to the fluid flow controller. In some embodiments, the controller compares the measured fluid flow rate to a desired fluid flow rate (which may be predefined, estimated, or deterministically derived) and adjusts the power level to the metering device accordingly. In some embodiments, the humidification fluid is preheated before being delivered to the heating element for vaporization to reduce the amount of latent heat required by the heating element to vaporize the humidification fluid. Various modes of preheating the humidification fluid may be used, including heating a fluid reservoir, heating a fluid supply line, or having a special fluid preheat zone of the heating element before reaching the vaporization region. According to some embodiments, a check valve is placed before the metering device in the fluid supply line to prevent backflow of the humidification fluid.In some embodiments, a relief valve is placed in the fluid supply line before the metering device to relieve pressure in the line due to pump failure among other possible causes. The heater plate controller can include a heated surface subsystem that monitors and controls the temperature of the heating element. The heating surface includes an area where the humidification fluid is dispersed and vaporized by thermal energy provided by the heating surface. A wicking element is provided on at least a portion of the heating surface. The wicking element is configured to receive and distribute a layer of humidification fluid having a thickness over one or more portions of the heating surface that provide heat to vaporize the fluid. The wicking element can include paper, fabric, microfiber, or microstructures including microfluidic channels (e.g., molded and bonded via a bonding layer onto the heating surface). The heating surface can include a heating plate, a resistive heating plate, or a circuit board with resistive tracks, to name a few. In some embodiments, the heating surface is a circuit board molded with a molding material, e.g., a thermoplastic material, as disclosed elsewhere herein. In some embodiments, multiple heating surfaces or zones can be used. Each heating surface can be maintained at the same or different temperature levels. A heating surface temperature sensor is in thermal contact with the heating surface and in communication with the heating surface temperature controller. A surface heater, also in communication with the surface temperature controller, is configured to control the temperature of the heating surface, or multiple heating surfaces or zones, depending on the configuration of the heating surface.

[0253] FIG. 16A is a perspective view of an example integrated humidification system 700 according to one embodiment of the present disclosure. FIG. 16B is a longitudinal section view of the humidification system 700 showing air flow. FIG. 16C is a longitudinal section view of the humidification system 700 showing water flow. FIG. 16D is a horizontal section view of the humidification system 700. In some configurations, the humidification system 700 can be a stand-alone humidifier that uses ambient air and relies on normal patient breathing to generate gas flow. In some configurations, the humidification system 700 can be an extension to a breathing circuit for use with any flow generation system, for example, a ventilator. FIG. 16E and FIG. 16F show the humidification system 700 installed for use with a flow generation system in an integrated system.

[0254] As shown in FIG. 16A, the humidification system 700 includes a housing 703, a gas inlet 731, and a gas outlet 733. The gas inlet 731 is configured to receive gas into the humidification system 700. In some configurations, the gas inlet 731 is adapted to connect to a gas inlet tube, a flow generation system, or other gas source. The gas outlet 733 is configured to deliver humidified gas out of the humidification system 700 to the patient. In some configurations, the gas outlet 733 is adapted to connect to a gas outlet tube, for example, a breathing tube connected to a patient interface (e.g., a cannula). The humidification system 700 also includes one or more water inlets 708 configured to allow water to be received into the humidification system 700 from a water flow controller. In some embodiments, the humidification system 700 includes an inlet and an outlet for water. In some embodiments, it includes only an inlet because all water put into the system is vaporized to humidify the gas. The humidification system 700 also includes an electrical connector 751 that provides power to the system and communicates with the various components of the system. The humidification system can also serve to provide power to the heated breathing tube and built-in sensors, and this design acts as a conduit for downstream system components that require power or communication. FIG. 16B is a longitudinal cross-sectional view of the airflow of the humidification housing of FIG. 16A. As shown in FIG. 16B, the housing 703 defines a gas flow path 738. In this configuration, gas enters the humidification system 700 at the gas inlet 731 and is directed downward by the inner wall 737. An opening 738 at the bottom of the inner wall 737 allows the gas to pass to the other side of the inner wall 737, where the gas is directed upward and out of the humidification system 700 at the gas outlet 733. The housing 703 can include an internal baffle 705. Along the flow path 735, the gas is humidified by the vaporized water that evaporates from the heating element 714. Heating element 714 is partially visible through gas inlet 731 in Figure 16A, and a cross section of heating element 714 is visible in Figures 16C and 16D. An example configuration of heating element 714 is described as heating element 800 with respect to Figures 15A-15C.In some embodiments, any part of the respiratory humidification system, such as the housing, inlet, outlet, etc., comprises a molded member which may contain one or more PCBs.

[0255] FIG. 16C is a vertical cross-sectional view of the water flow in the humidification housing of FIG. 16A. In the configuration shown, water entering through the inlet 708 is distributed through the channel 718 to contact the heating element 714. In the configuration shown, the channel 718 is partially located within the inner wall 737. As shown, most or substantially all of the heating element 714 is encapsulated (e.g., surrounded, sealed, etc.) within a molding material that can be bonded to a substrate of the heating device via a bonding layer. FIG. 16D is a horizontal cross-sectional view of the humidification housing of FIG. 16A. As shown in FIG. 16D, the heating element 714 can divide the housing 703 in a first direction, and the inner wall 737 can divide the housing 703 in a second direction orthogonal to the first direction. Thus, the heating element 714 is immersed within the flow path. In some configurations, this configuration effectively doubles the surface area, dramatically increasing power efficiency, making surface temperature readings more accurate, and allowing the housing 703 to remain relatively cool (and therefore safe). The embodiment of FIG. 16D includes a baffle 705 in the air flow path.

[0256] 16E and 16F show the humidification system 700 installed for use with one embodiment of a flow generation system 790. The flow generation system 790 can include a gas inlet 791 that connects to an external gas source and a gas outlet 793 that can be adapted to connect to the gas inlet 731 of the humidification system 700. In the illustrated configuration, the flow generation system 790 includes a plurality of inlet controls 795. In some configurations, the flow generation system 790 can be an Airvo available from Fisher & Paykel Healthcare of Auckland, NZ. In some embodiments, one or more components of the flow generation system (e.g., flow tubes, etc.) include sensors molded into and coupled to the molded material via a bonding layer within a molded member (disclosed elsewhere herein) of the system.

[0257] Figure 15A is a perspective view of one embodiment of a heating element 800 according to one embodiment of the present disclosure. Figure 15B is a top view of the heating element 800. Figure 15C is a partial top view of the heating element 800. In some configurations, the printed circuit board heating element 800 can be used as the heating device 814 of the humidification system 700 described above with respect to Figures 16A-16F, or as any other heating device described herein (e.g., heating device 614 of Figures 14A-14C), as disclosed elsewhere herein.

[0258] As disclosed elsewhere herein, the heating element 800 may include a printed circuit board 801 that provides heating. The printed circuit board 801 may include a plurality of resistive tracks 811. The resistive tracks 811 may be copper and / or aluminum. The outer surface of the heating element 800 may include a wicking surface. The wicking surface may be provided by a molding material on the printed circuit board 801 (and bonded via a bonding layer). The molding material may have microchannels therein (the microchannels are described in more detail below). The molding material may be a thermoplastic material as disclosed elsewhere herein and / or may be a thermosetting material. The heating element 800 may have modular zones. For example, in the illustrated embodiment, the resistive track 811 is divided into three modular zones 803, 805A, 805B. In some configurations, the modular zones 805A and 805B are connected in series. In some configurations, the heating element 800 can have a first zone configured to preheat the water and a second zone configured to vaporize the water, as described with respect to FIG. 15C. A single zone can be wetted and powered. This allows flexibility to the controller. Alternatively, the entire heater surface can be powered and the entire heater surface can be kept wetted rather than operating isolated zones.

[0259] As shown in FIG. 15B, the heating element 800 can include electrical contacts 857 (either for power transfer or communication) that can be used to power additional components of the respiratory humidification system. While the remainder of the heating element can be covered (e.g., encapsulated) by the molding material, these electrical components may span the walls or surfaces of the molding material and may be connected, for example, to electrical conduits or the like outside the humidification chamber of the humidification system. In some embodiments, the electrical contacts 857 can provide power to a heated breathing tube (HBT). As another example, the electrical contacts 857 can be used to power or communicate with additional sensors (e.g., temperature sensors, pressure sensors, or other sensors described herein, which can be molded and bonded to the molding material via a bonding layer).

[0260] In some embodiments, the microchannels can provide a wicking surface. The wicking surface can work synergistically with the gas preheating to ensure that the heated surface is maintained at a relatively low temperature. This is because lower temperatures require a larger surface area to generate the necessary vapor flux, and larger areas require more efficient mechanisms to distribute the liquid to recruit more of the heated surface for vaporization. In some configurations, the microchannels can be small-scale (e.g., microscale) grooves formed on a surface. The surface can be flat or curved. In some configurations, the microchannels can be highly ordered. In some configurations, the microchannels are arranged in a pattern (see, e.g., FIG. 17A for one example of a lattice structure pattern and FIG. 17B for one example of a radial pattern, these examples are non-limiting and other patterns are possible). In some configurations, the purpose of the microchannels is to distribute the liquid across a surface, thereby increasing its surface area for a given volume. In some configurations, the microchannels have a substantially uniform cross-sectional profile along their length. For example, a microchannel can have a circular or semicircular, elliptical or semi-elliptical, rectangular, triangular (V-shaped), or trapezoidal cross-section. In some configurations, a microchannel can include rounded edges and / or corners. In some configurations, a microchannel can have a variable cross-sectional profile that changes over the length of the microchannel. For example, a microchannel can become deeper and / or wider along its length. A microchannel can be an "open" microchannel that includes at least one side that opens to the environment. For example, a microchannel can be a V-shaped groove formed in a surface, and liquid in or on the microchannel can open to the environment at least at the open side of the V. Such a microchannel can promote vaporization of a liquid because the open side of the microchannel provides a place for the vaporized liquid to go. For example, the open side of an open microchannel can open to a gas passage.Liquid on or in the microchannel can be vaporized, and the vaporized liquid can be entrained in the gas flowing through the gas passage. In some configurations, the microchannel can have a depth (which can also be considered a height) of about 1 μm, 10 μm, 20 μm, 30 μm, 50 μm, 100 μm, 200 μm, 500 μm, 1000 μm, or a range including and / or ranging from the values ​​mentioned above. In some configurations, the microchannel can have a width of about 1 μm, 10 μm, 20 μm, 50 μm, 100 μm, 200 μm, 500 μm, 1000 μm, or a range including and / or ranging from the values ​​mentioned above. In some configurations, the slope of the sidewall of the microchannel can range from 0 to 45 degrees. The slope of the sidewall as used herein is measured between the wall and a vertical surface (in other words, between the wall and an axis extending perpendicular to the surface in which the microchannel is formed). That is, a wall gradient of 0 degrees represents generally vertical walls. For example, if the sidewalls of a microchannel include a wall gradient of 0 degrees, the microchannel may be substantially square-shaped, and the square may be open at the top. In another example, if the sidewalls of a microchannel include a wall gradient of 45 degrees, the microchannel may be substantially V-shaped if the gradient sidewalls intersect directly, or substantially trapezoidal shaped if the sidewalls intersect a horizontal flat bottom surface of the microchannel, and the top of the microchannel may be open. In some configurations, the gradient of the sidewalls of the microchannel may range from 5 to 20 degrees. Microchannels can spread liquids by wicking (capillary action) or, in some cases, by gravity flow of the liquid through the channel. In some configurations, the microchannels can be defined by protrusions extending above a surface, in which case the microchannels are formed by the spaces between the protrusions.

[0261] In some configurations, the heating element 800 includes one or more sensors that measure the temperature of the surface of the heating element 800. The one or more sensors may be a thermistor 821. In some configurations, the heating surface temperature may be calculated, at least in part, by determining a resistance level or other characteristic of the heating element 800. The resistance level of the heating element may be used to indicate an average temperature of the heating surface. The heating element may be arranged to provide a higher power density to a designated area of ​​the heating element compared to the power density provided to other areas of the heating element. The designated relatively dense area of ​​the heating element may be located at the outlet of the water supply to the heating surface. The designated relatively dense area of ​​the heating element may be located at a water pre-heating area at the heating surface. The respiratory humidification system may include a temperature sensor at the exit location of the gas channel, which may act as a safety check.

[0262] The resistive track 811 and / or the sensor, e.g., thermistor 821, may be electrically connected to electrical contacts 852 positioned on a contact area 851 of the printed circuit board 801 (which may, for example, extend from a molding compound encapsulated portion of the PCB to an area external to the chamber (e.g., the humidification chamber)). The contact area 851 may be positioned to mate with an electrical connector 751 of the humidification system 700.

[0263] In some configurations, the heating element 800 is configured to provide some "pre-heat" to the water. This can be accomplished in some configurations by simply increasing the track (and therefore power) density in the area where the water is introduced. This zone has a power density increased by the additional amount needed to heat the water in a small area. For example, as shown in FIG. 15C, if water is introduced to the heating element 800 at location 808 and the surface of the heating element is configured to wick the water across the heating element 800 in the direction of the arrow, the heating element 800 can include a relatively high density of resistive tracking 811 at and around location 818 (in other words, closer to location 808 where the water is introduced) and a relatively low density of resistive tracking 811 around location 828 (in other words, farther from location 818). In some embodiments, the air and / or water is pre-heated by the heating element. Another option for providing preheat to the water is to include a heater in the water supply line (i.e., between the pump / flow sensor and the coupling to the surface), which could be a PTC (positive temperature coefficient) element, or a heating coil, or any other heater, in thermal contact with the water flow that heats the water to the same temperature as the surface of the heating element 800. Although the heating element 800 has been described above with respect to heating water, a similar heating element 800 could also be used to heat gas, for example as a gas preheater.

[0264] FIG. 15D shows a top view of two alternative embodiments of heating elements 800A, 800B according to an embodiment of the present disclosure. The heating elements 800A, 800B can include etched foil films 801A, 801B. The etched foil films 801A, 801B can include a plurality of resistive tracking 811A, 811B. The heating elements 800A, 800B can also include electrical connections 851A, 851B, respectively. These electrical connections can be located outside the overmolded portion of the heating element. For example, as disclosed elsewhere herein, the heating portion of the PCB can be inside the chamber of the system, encapsulated by the molding material and fused to the molding material via a bonding layer, while the electrical conduit is outside the chamber. In some embodiments, the circular embodiment 800B can provide the bottom or top of the chamber humidification system (e.g., as shown in FIG. 4A). FIG. 15E shows an embodiment of the heating element 800A in a rolled configuration.

[0265] In some configurations, the humidification system includes various components that provide humidification fluid to the heating element, such as a distribution and / or wicking system. In some configurations, it is preferable to provide water to the heating element surface across its entire surface, in other words, to saturate the surface. In some embodiments, the distribution / wicking system can maintain a flow rate. In some configurations, it is not enough to simply distribute water onto the surface if the distributor cannot wick the water fast enough to keep the heating element saturated. In some configurations, the distributor can maintain a liquid flow rate of about 0 mL / min to about 5 mL / min, about 1 mL / min to about 4 mL / min, and about 2 mL / min to about 3 mL / min.

[0266] The distribution and / or wicking system can include two parts: a wicking surface that distributes water across the surface, and a coupling portion that connects a water source to the surface at one or more points. The coupling portion can also do some of the water distribution (e.g., by coupling water across an area or line rather than a point). Technologies that can be used for both coupling and wicking include, but are not limited to, fabric / paper (e.g., Kimberly-Clark Hydroknit); microchannels; hydrophilic coatings (e.g., Lotus Leaf Coatings HydroPhil); capillary / contact wicks (custom designs) and / or porous polymers (e.g., Porex fiber). In some configurations, the wicking surface can be a microchannel surface, which can include, among other possible configurations, parallel channels in only one direction; a small set of distribution channels connected to a larger number of main channels; and / or channels that are radially distributed from a single point. The wicking surface can also be an absorbent fiber or paper, a superhydrophilic coating surface, or a thin porous medium.

[0267] FIG. 17A illustrates an embodiment of a lattice microchannel water distribution pattern 900A according to an embodiment of the present disclosure. The distribution pattern 900A includes a water input area 901A, a first microchannel 902A, and a second microchannel 903A. The first microchannel can act as a distribution channel that distributes water to the second microchannel. The second microchannel distributes water across the surface. The lattice microchannel water distribution pattern 900A can be applied to the surface of the heating element 800 (e.g., as a molding compound that is molded and bonded to a PCB as a substrate via a bonding layer). The lattice microchannel water distribution pattern 900A is one example of a wicking element described herein. In some configurations, the first microchannel 902A moves water in a first direction and the second microchannel 903A moves water in a second direction orthogonal to the first direction. However, the lattice microchannel water distribution pattern can be modified to include the first microchannel oriented at other positions relative to the second microchannel. In some configurations, the lattice microchannel water distribution pattern includes only the first microchannel or only the second microchannel. In general, a lattice microchannel water distribution pattern is a system in which the microchannel distributes water, i.e., water is fed into several distribution channels, which then split into many channels that wick across most of the surface.

[0268] FIG. 17B illustrates a radial microchannel water distribution pattern 900B according to one embodiment of the present disclosure. FIG. 17B is a still image taken from a video showing radial microchannels wicking fluorescent dye. The fluorescent dye was dropped onto a central point 901B and wicked outward by the channels. The radial microchannel water distribution pattern 900B includes microchannels that radiate from a central point 901B where water is introduced. In some configurations, to maintain the same channel density, the microchannels can split to radiate outward from the central point 901B. The radial microchannel water distribution pattern 900B can also include microchannels that extend in a circumferential direction.

[0269] FIG. 18A is a perspective axial cross-sectional view of an embodiment of a respiratory humidification system 1000 including a glass slide interface 1031 according to an embodiment of the present disclosure. FIG. 18B is a perspective side cross-sectional view of the respiratory humidification system 1000 of FIG. 18A. FIG. 18C is a side view of the respiratory humidification system 1000 of FIG. 18A. FIG. 18D is a perspective assembled axial view of the respiratory humidification system 1000 of FIG. 18A. The glass slide interface 1031 can be considered a contact angle / capillary line distributor. In the illustrated embodiment, the respiratory humidification system 1000 includes a gas inlet 1001 and a gas outlet 1003 with a gas flow path 1005 extending therebetween. Gas is humidified in the flow path 1005 as it travels from the inlet 1001 to the outlet 1003. The respiratory humidification system 1000 also includes a micropump 1021 adapted to supply water into the system from a water source. Water is pumped into the flow path 1005 from the micropump 1021 via the water line inlet 1021. The respiratory humidification system further includes a glass slide interface 1031, which is held at an acute angle 1025 (see FIG. 18C) with respect to the surface 1033 of the heating element 1014. The surface 1033 includes microchannels that extend in the direction of the arrow and perpendicular to the glass slide 1031. The water line 1023 is disposed at the intersection of the glass slide interface 1031 and the surface 1033. Due to the acute angle 1025 (see FIG. 18C) between the glass slide interface 1031 and the surface 1033, the water is wicked along the intersection and then across the surface 1033 by the microchannels. Notably, the interface 1031 exposes the heater element 1014 on only one side, although in some configurations this design can be modified to expose the heater element 1014 on both sides. The respiratory humidification system 1000 may also include a honeycomb gas diffuser 1045 in the gas flow path 1005. The heating elements described herein may be partial PCBs that are molded with a molding material to provide a molded member that includes a bonding layer.

[0270] 19 is a perspective view of a distribution pipe connection 1100 wrapped around the edge of a heating element 1114 according to one embodiment of the present disclosure. This view shows a tube 1101 being used as a connection or distributor. The tube 1101 clips onto the heating element 1114 and water is then pumped into the tube 1101. As the tube 1114 fills, water is drawn across the heating element 1114. In particular, the pipe connection 1100 can distribute water to both the top 1114a and bottom 1114b of the heating element 1114. In some embodiments, the tube comprises a shaped member as disclosed elsewhere herein.

[0271] 20 is a diagram of a porous media interface 1200 according to one embodiment of the present disclosure. The interface 1200 is shown as a chopped strip extending along the surface of the heating element 1214. The interface can be, for example, a piece of fabric. Water can be poured onto the fabric and distributed along the microchannels. In some configurations, the interface 1200 can be a thin porous media, such as a porous or sintered polymer. In some embodiments, the polymer or other material is molded onto and attached to the heating element via a bonding layer as disclosed elsewhere herein.

[0272] FIG. 21A is a perspective view of a radial connector 1300 according to one embodiment of the present disclosure. FIG. 21B is a perspective cross-sectional view of the radial connector 1300 of FIG. 21A. The radial connector 1300 can be considered a cavity / surface connector. Generally, the connector 1300 pushes water to the surface of the heating element. In some configurations, the connector 1300 is configured to work with surfaces that are sufficiently hydrophilic or absorbent. In some configurations, the connector 1300 is adapted so that, if there are multiple outlets, the outlets are balanced, e.g., water does not simply prefer one path and flow in that direction entirely. In some embodiments, the connector 1300 receives a supply of water at an inlet 1301 and supplies it radially at the center of the heating element and to both sides. As shown in FIG. 21B, water flows from the inlet 1301 down a series of channels 1303 to the heating element (not shown). The connector 1300 can include multiple outlets 1305. In some configurations, the connection 1300 also pumps water through a central channel 1307 that extends through the holes in the heating element to a similar system on the other side. In Figure 21B, arrows have been added to show the flow of water.

[0273] FIG. 22A is a perspective view of a sandwich joint 1400 according to one embodiment of the present disclosure. FIG. 22B is a perspective cross-sectional view of the sandwich joint 1400 of FIG. 22A. The joint 1400 includes a body 1401 with one or more protruding portions 1403. A water outlet 1405 can be positioned on one or each of the inwardly facing surfaces of the protruding portions 1403. As shown in FIG. 22B, the joint 1400 includes a water inlet 1411 and an internal channel that routes water to the water outlet 1405. Arrows have been added to FIG. 22B to show the flow of water. A heating element (as shown in FIG. 22C and FIG. 22D) can be positioned between the protruding portions 1403 and receive water from the outlet 1405. As disclosed elsewhere herein, the heating element can be coupled (e.g., secured) to the molding material (e.g., part of the sandwich joint) via a bonding layer. Figure 22C is a cross-sectional view of the sandwich coupling 1400 of Figure 22A attached to a humidification housing 703 according to one embodiment of the present disclosure. Figure 22D is a cross-sectional view of the sandwich coupling 1400 of Figure 22A attached to a humidification housing 703 including a printed circuit board heating element 800 according to one embodiment of the present disclosure. The housing 703 may be similar to the housing 703 of the humidification system 700 described with respect to Figures 16A-16D. The heating element 800 may be similar to the heating element 800 described with respect to Figures 15A-15C.

[0274] FIG. 23A is a perspective view of an alternative embodiment of a humidification system 1500 according to an embodiment of the present disclosure. FIG. 23B is a cross-sectional view of the humidification system 1500 of FIG. 23A. As shown in FIG. 23B, the humidification system 1500 includes a top layer and a bottom layer. FIG. 23C is a cross-sectional view of the top layer of the humidification system 1500 of FIG. 23A. FIG. 23D is a cross-sectional view of the bottom layer 1500 of the humidification system of FIG. 23A. The humidification system 1500 can include a gas inlet 1501 and a gas outlet 1502. The humidification system can include a blower 1531 configured to move gas from the gas inlet 1501 to the gas outlet 1502. The inlet 1501 and the outlet 1502 can be connected by a channel. A flow sensing device 1551 and a gas sensing device 1581 can be located within the channel. The flow sensing device and portions of the gas sensing device may be overmolded and bonded to the molding material via a bonding layer as disclosed elsewhere herein. Humidification system 1500 includes a power / communications connector 1503.

[0275] The humidification system 1500 can include a heater face cavity 1511 configured to receive a heating element as described elsewhere herein. The heating element can be molded with a bonding material via a bonding layer as described elsewhere herein. The heater face cavity also includes a water inlet portion 1561 that can be configured to have a connection to apply water to the heating element. The water inlet portion 1561 can be in fluid communication with the liquid flow module 1541, the water inlet 1542, the check valve 1543, and the micron pump 1544. The humidification system 1500 can also include an electronics cavity 1571 accessible via a port 1572.

[0276] FIG. 24 is a diagram of an in-line humidification system according to one embodiment of the present disclosure. The in-line humidification system of FIG. 24 includes a preheater and a heater (the heater represented by a heating surface) in the gas path between the inlet and the outlet. A heater controller is connected to both the preheater and the heater. The preheater heats the gas before it reaches the heater. The heater is also connected to a water controller that dispenses water onto the heating surface. The amount of water applied by the water controller and the amount of heat applied by the heater controller can be deterministically controlled according to the principles described herein to vaporize the water and humidify the gas. The outlet of the system can be connected to a heated breathing tube (HBT), i.e., an intake or delivery tube. The necessary power and sensing systems for the HBT can be provided integrally by the humidification system or provided separately or externally. The advantages of including the humidification system as part of the delivery tube are simplicity, cost savings, and quality control by ensuring that it is replaced when necessary.

[0277] Reference is now made to Figure 25, which is a diagram of a medical insufflation humidification system including a humidifier and / or humidification chamber constructed and operable in accordance with one embodiment. Figure 25 shows an insufflation humidification system 1600 for delivering a temperature and humidity controlled gas flow to a patient 1602, the insufflation system 1600 having a humidification device or humidifier 1604 incorporating a humidifier control system 1606. The humidifier 1604 is connected to a gas source 1608 through an inlet conduit 1610. The humidifier 1604 delivers humidified gas to the patient 1602 through a gas delivery conduit 1612. The conduits 1610, 1612 can be made from flexible plastic tubing. The conduits 1610, 1612 form part of a breathing circuit, which is a gas flow path that delivers gas from the gas source 1608 to the patient. The gas source 1608 may be integrated with the system 1600 and may comprise a flow generator including, for example, a blower (i.e., the gas source 1608 and the humidifier 1604 may be combined to form a single device, or the two separate components may be modular and configured to couple to each other without the need for a separate conduit between them, as is known in the art). Alternatively or in addition, the gas source may be separate but connected to the system 1600, and may include, for example, a hospital compressed gas source.

[0278] The humidifier 1604 may receive gas from a gas source 1608 through a gas supply or inlet conduit 1610. The gas may be filtered through a filter 1611 and sent to the humidifier 1604 through a humidifier inlet 1614. The gas is humidified as it passes through a humidification chamber 1616 and flows out through a humidifier outlet 1618 into a patient conduit 1612. The gas then travels through the patient conduit 1612 to the patient 1602 via a connector 1640 (e.g., a luer connector) and a patient interface 1636. The patient interface 1636 may be, for example, but is not limited to, a trocar or cannula for laparoscopic surgery or a diffuser for open surgery. The patient conduit 1612 includes a gas delivery conduit that forms part of a breathing circuit that includes one or more conduits or tubes that form a gas flow path between a flow generator and a patient, including the gas supply conduit 1610.

[0279] The humidifier chamber 1616 may be removably engageable with the body 1624 of the humidifier 1604. The humidifier chamber 1616 may comprise sidewalls and a base / bottom. The humidifier chamber 1616 may further comprise a top, an openable lid, or may be topless (e.g., lidless, in which case the humidifier chamber 1616 may be received within a sealable cavity of the humidifier body 1624). In some embodiments, the top, base, and sidewalls together may define any one of a substantially circular chamber, a substantially square chamber, a substantially rectangular chamber, or other shapes (such as a triangle) when the chamber is viewed from above. In the case of a rounded (e.g., circular) chamber, the sidewalls may be arcuate in shape and may define other arcuate shapes. For example, the chamber may be an elliptical chamber when viewed from above, or any other chamber having an arcuate, but not necessarily perfectly circular, shape when viewed from above. The chamber may be symmetrical about at least one axis when viewed from above. Preferably, the chamber is symmetrical about two axes, a horizontal axis and a vertical axis when viewed from above.

[0280] The base 1621 of the humidification chamber 1616 may have thermally conductive (e.g., metal) areas or may be completely thermally conductive and may be adapted to hold a volume or reservoir 1620 of water that may be heated by a heater plate 1622. The heater plate 1622 may include a heating element configured to provide heat to a heating surface. As disclosed elsewhere herein, the heating plate and / or heating element may be part of a molded member that is bonded to a molding material (e.g., chamber base) via a bonding layer. The heater plate 1622 may be in thermal contact with the thermally conductive base 1621 of the humidification chamber 1616. By providing power to the heater plate 1622, heat may flow from the heater plate 1622 through the thermally conductive base 1621 to the water 1620. When heated, the water 1620 in the humidification chamber 1616 can vaporize, and the vaporized water can mix with gas flowing through the humidification chamber 1616 from the gas source 1608, optionally via filter 1611. Thus, the humidified gas exits the humidification chamber 1616 via the outlet 1618, passes through the patient conduit 1612, the connector 1640, the patient interface 1636 to the patient 1602, and into the surgical site, for example to insufflate the surgical site and / or expand a body cavity.

[0281] The humidifier 1604 includes a humidifier control system 1606 configured to control the temperature and / or humidity of the gas being delivered to the patient 1602. The humidifier control system 1606 can be configured to regulate the amount of humidity provided to the gas by controlling the power provided to the heater plate 1622. The humidifier control system 1606 can control the operation of the humidifier system 1604 according to instructions set in software and in response to system inputs. The system inputs can include a heater plate sensor 1626, a chamber outlet temperature sensor 1628, and a chamber outlet flow sensor 1630. For example, the humidifier control system 1606 can receive temperature information from the heater plate sensor 1626 and use this information as input to a control module that is used to control the power or temperature setpoint of the heater plate 1622. The humidifier control system 1606 can be provided with inputs of the temperature and / or flow rate of the gas. For example, a chamber outlet temperature sensor 1628 may be provided to the humidifier control system 1606 to indicate the temperature of the humidified gas as it exits the outlet 1618 of the humidifier chamber 1616. The temperature of the gas exiting the chamber may be measured using any suitable temperature sensor 1628, such as a wire-based or PCB-based temperature sensor. A chamber outlet flow sensor 1630 may be provided to indicate the flow rate of the humidified gas to the humidifier control system 1606. The flow rate of the gas through the chamber 1616 may be measured using any suitable flow sensor 1630, such as a hot wire anemometer or a thermistor configured to be used as a flow sensor. In some embodiments, the temperature sensor 1628 and the flow sensor 1630 are in or otherwise provided in the same sensor housing. The temperature sensor 1628 and the flow sensor 1630 may be connected to the humidifier 1604 via a connector 1632. For example, additional sensors may be incorporated into the air delivery system 1600 to sense parameters at the patient end of the patient conduit 1612. Alternatively, the sensors may be wirelessly coupled to the controller.Alternatively, the connector may be internal, i.e., the sensor is coupled to the controller by an integrated wire rather than an external cable. The sensor (flow sensor, humidity sensor, temperature sensor, etc.) may be a substrate (e.g., PCB) with one or more sensing areas to which the molding compound is bonded via a bonding layer as disclosed elsewhere herein.

[0282] The humidifier control system 1606 can be in communication with the heater plate 1622 such that it can control the power supplied to the heater plate 1622 and / or control the temperature setpoint of the heater plate 1622. As described further herein, the humidifier control system 1606 can determine the amount of power to supply to the heater plate 1622 or the heater plate setpoint based, at least in part, on any one or more of the flow conditions, the operating mode, the flow rate readings, the outlet temperature readings, and the heater plate sensor readings.

[0283] The air delivery system 1600 can include a conduit heating wire 1634 configured to provide heat to the gas traveling along the patient or gas delivery conduit 1612. In some embodiments, the heating wire is a resistive track on a PCB. In some embodiments, the PCB is coupled to the molding compound via a bonding layer as disclosed elsewhere herein. The gas exiting the outlet 1618 of the humidifier chamber 1616 can have a high relative humidity (e.g., about 100%). As the gas travels along the patient conduit 1612, water vapor can condense on the conduit walls, reducing the moisture content of the gas. In some embodiments, the conduit heating wire 1634 can be provided in the gas flow path along all or a portion of the patient conduit to reduce condensation of the gas within the conduit. In some embodiments, the conduit heating wire 1634 can be embedded within the wall of the patient conduit. In some embodiments, the conduit heating wire 1634 can be external to the patient conduit along all or a portion of the patient conduit. In some embodiments, the heating wire can be positioned at least partially within the wall of the patient conduit. Power can be provided from the humidifier 1604 to the conduit heating wire 1634 and can be controlled through the humidifier control system 1606. In some embodiments, the heating wire 1634 is configured to maintain the temperature of the gas flowing through the patient conduit 1612. In some embodiments, the conduit heating wire 1634 can be configured to provide additional heating of the gas to increase the gas temperature to maintain the humidity generated by the heated water bath in the humidifier 1604. The conduit heating wire can be provided on the substrate and on a portion of the molded member.

[0284] The gas delivery conduit can be single-walled or have a dual-conduit configuration including an outer conduit and an inner conduit. The inner conduit carries the gas and can include a heating wire 1634. The outer conduit can provide insulation for the inner conduit. The outer and inner conduits can be coaxial and there can be an air gap between the outer and inner conduits.

[0285] A further filter or filter assembly (not shown) may optionally be provided and positioned between the humidifier 1604 and the patient interface 1636 in use to allow reuse of the inlet conduit 1610 and / or the inhalation conduit and possibly reuse of the humidification chamber 1616. The filter assembly may comprise a filter media for filtering gases exiting the outlet 1618 of the humidification chamber 1616. The filter assembly may also comprise a housing and a heating element. The filter media may be positioned within the housing such that the humidified gases flowing through the housing are filtered to remove particles. The heating element may be positioned in the gas flow path between the inlet and outlet of the housing, but spaced apart from the filter media and the housing. In some embodiments, the housing for the filter and / or heating element is or comprises a shaped member as disclosed elsewhere herein. The heating element may be configured to heat the filter media to reduce condensation and prevent the filter from clogging. Such filters are described, for example, in WO 2018 / 106127, the entirety of which is incorporated by reference herein.

[0286] The connector 1640 may be a luer connector comprising a body having an interior region defining a gas flow passageway through which insufflation gas can flow. The body may comprise a first end that removably connects to a fitting of the patient interface 1636 and a second end that is preferably permanently attached to the tube of the patient conduit 1612. It will be appreciated that the luer connector 1640 of FIG. 25 may be a high flow luer connector that provides certain sealing and retention characteristics that provide less resistance to gas flow than conventional luer connectors in the art. An embodiment of such a high flow luer connector is described, for example, in WO 2018 / 097738, which is incorporated herein by reference in its entirety.

[0287] In some embodiments, the humidifier chamber 1616 of the humidifier 1604 can be configured to provide a controlled gas flow pattern for the insufflation gas. The humidifier chambers according to embodiments described herein, including those shown in Figures 4A-7B, provide high humidification levels and strong bonding between the molded material and the heating surface. The embodiments herein are particularly adapted for use in respiratory systems such as CPAP or high flow respiratory gas systems, e.g., high flow systems used in anesthesia and sedation procedures. Respiratory systems in which the chambers may be particularly useful are CPAP, BiPAP, high flow therapy, variable high flow therapy, low flow air, low flow O2 delivery, bubble CPAP, apnea high flow (i.e., high flow to anesthetized patients), invasive ventilation, and non-invasive ventilation. Additionally, the chambers described herein may be useful in systems other than respiratory systems.

[0288] High flow therapy as discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art, generally referring to a respiratory assistance system that delivers a target flow rate of humidified respiratory gas through an intentionally unsealed patient interface at a flow rate generally intended to meet or exceed the patient's inspiratory flow rate. Exemplary patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range, but are not limited to, from about 15 liters / minute to about 70 liters / minute or more. Typical flow rates for pediatric patients (such as neonates, infants, and children) often range, but are not limited to, from about 1 liter / minute per kilogram of patient weight to about 3 liters / minute per kilogram of patient weight or more. High flow therapy can also optionally include administration of a gas mixture composition and / or therapeutic agent that includes supplemental oxygen. High-flow therapy is often referred to as nasal high flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high flow (THF), among other common names. In some configurations, the flow rate of gas supplied or provided to the interface through the system or from a flow source includes flow rates of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 liters per minute (LPM) or more, and useful ranges may be selected to be any of these values ​​(e.g., about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).

[0289] High flow therapy can be used as a means to promote gas exchange and / or respiratory support through the delivery of oxygen and / or other gases and through the removal of CO2 from the patient's airways. High flows of delivered gas can be particularly useful before, during, or after a medical procedure. When used before a medical procedure, high gas flows can pre-charge the patient with oxygen so that the patient's blood oxygen saturation and the amount of oxygen in the lungs are high to provide an oxygen buffer while the patient is in the apneic phase during the medical procedure. During medical procedures (such as during anesthesia) where respiratory function may be compromised (reduced or stopped), a continuous supply of oxygen is essential to maintain healthy respiratory function. When this supply is compromised, hypoxia and / or hypercarbia can occur. During medical procedures, such as anesthesia and / or general anesthesia where the patient is unconscious, the patient is monitored to detect when this occurs. If oxygen delivery and / or CO2 removal is compromised, the clinician stops the medical procedure and promotes oxygen delivery and / or CO2 removal. This can be accomplished, for example, by manually ventilating the patient through an anesthesia bag and mask, or by using a high-flow therapy system to provide a high flow of gas to the patient's airway. These high-flow systems can include shaped members as disclosed herein. Additional benefits of high-flow gas flow include that it increases pressure within the patient's airway, thereby providing pressure support to keep the airway, trachea, lungs / alveoli, and bronchioles open. The patency of these structures promotes oxygenation and, to some extent, aids in the removal of CO2. The increased pressure can also keep structures such as the larynx from obscuring the vocal cords during intubation. When humidified, high-flow gas flow can also keep the airway from drying out, reducing mucociliary damage and reducing the risk of laryngospasm and the risks associated with airway drying, such as nosebleeds, aspiration (as a result of nosebleeds), and airway obstruction, swelling, and bleeding. Another benefit of high gas flow is that the flow can clear smoke that is generated during airway surgery. For example, the smoke may be generated by a laser and / or ablation device.

[0290] Pressure relief or regulating devices are particularly desirable for use in respiratory systems, such as high flow systems with unsealed patient interfaces, to provide an upper pressure limit for the system. Most importantly, the upper pressure limit can be configured to provide a patient safety limit or to prevent damage to tubing, fluid connections or other components. Pressure relief or regulating devices can be used in CPAP (Continuous Positive Airway Pressure), BiPAP (Bilevel Positive Airway Pressure) and / or Bubble CPAP systems to regulate the pressure provided to the patient. Exemplary CPAP devices are described in WO 2011 / 056080, the contents of which are incorporated herein by reference in their entirety.

[0291] The gas delivery system disclosed herein may include one or more of the following features: The system may include a flow source, such as an in-wall oxygen source, an oxygen tank, a blower, a flow therapy device, or any other source of oxygen (e.g., compressed oxygen) or other gas (e.g., compressed air). The system may also include an additive gas source including one or more other gases that may be coupled to the flow source. The flow source may provide a pressurized high flow gas flow that may be delivered to the patient via a delivery conduit and a patient interface (such as a nasal cannula). A humidifier is also provided that may humidify the gas and, in some embodiments, adjust the temperature of the gas. The humidifier includes a humidification chamber as disclosed above. One or more sensors may be located throughout the system (on a PCB in the humidifier) ​​and / or at, on or near the patient, such as flow, oxygen, pressure, humidity, temperature, or other sensors. Portions of the blower, valves, sensors, and / or heating elements may be attached to and / or integrated with the system, as disclosed elsewhere herein.

[0292] In some embodiments, a controller may be provided in the gas delivery system. In some embodiments, the controller may be in communication with the flow source, the additive gas source, the humidifier, and the sensor. In some embodiments, the controller may control the flow source to provide a desired flow rate of gas. In some embodiments, the controller may control the flow rate, pressure, composition (if more than one gas is provided), volume, and / or other parameters of the gas provided by the flow source based on feedback from the sensor. In some embodiments, the controller may also control any other suitable parameters of the flow source to meet oxygenation requirements. In some embodiments, the controller may control the humidifier (e.g., based on feedback from the sensor). In some embodiments, using input from the sensor, the controller may determine the oxygenation requirements and control parameters of the flow source and / or the humidifier as needed.

[0293] In some embodiments, the humidified gas can be delivered to a patient via a delivery conduit and a patient interface or "interface" (as described elsewhere herein), such as a cannula, a mask, a nasal interface, an oral device, or a combination thereof, as described above. In some embodiments, a high flow gas flow (optionally humidified) can be delivered to a patient in surgical applications, for example for surgical insufflation. In these embodiments, the "interface" is a surgical interface, which may be a surgical cannula, a trocar, or other suitable interface. The patient interface may be substantially sealed, partially sealed, or substantially unsealed. As used herein, a nasal interface is a device such as a cannula, a nasal mask, nasal pillows, or other type of nasal device, or a combination thereof. A nasal interface may also be used in combination with a mask or oral device (such as a tube inserted into the mouth), and / or a mask or oral device (such as a tube inserted into the mouth) that can be detached and / or attached to the nasal interface. A nasal cannula is a nasal interface that includes one or more prongs configured to be inserted into the patient's nasal passages. Mask refers to an interface that covers the patient's nasal passages and / or mouth, and may include devices in which the portion of the mask that covers the patient's mouth is removable, or other patient interfaces such as laryngeal mask airways or endotracheal tubes. Mask also refers to a nasal interface that includes nasal pillows that create a substantial seal with the patient's nares. The controller controls the system to provide the required oxygenation.

[0294] In some embodiments of the system, a gas flow generator in the form of a motor / impeller arrangement is provided along with the humidifier. In some embodiments, the humidifier comprises a humidification chamber as disclosed above. In some embodiments, the controller is configured or programmed to control the components of the device, including operating the flow generator to generate a flow of gas (gas flow) to be delivered to the patient, operating the humidifier to humidify and / or heat the generated gas flow, receiving user input from a user interface for reconfiguration and / or user-defined operation of the device, and outputting information to a user (e.g., on a display). The user may be a patient, a medical professional, or another person interested in using the device. In some embodiments, the controller adjusts one or more parameters of the humidifier based on information collected from a sensor on a PCB (e.g., a PCB that is part of a molded member that may be on the humidifier).

[0295] In some embodiments, the respiratory assistance device may be a stand-alone humidifier device comprising a main housing and a humidifier. An exemplary stand-alone humidifier device is described in WO 2015 / 038013, the contents of which are incorporated herein by reference in their entirety.

[0296] The patient respiratory conduit may be connected to a gas flow exhaust or patient outlet port in the housing of the respiratory assistance device and may be connected to a patient interface, such as a nasal cannula with a manifold and nasal prongs. Additionally or alternatively, the patient respiratory conduit may be connected to a face mask (or other respiratory system patient interface). Additionally or alternatively, the patient respiratory conduit may be connected to a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface, or other suitable type of patient interface. A humidified gas flow generated by a respiratory system (e.g., a respiratory assistance device) may be delivered to a patient through a patient interface via the patient respiratory conduit. The patient respiratory conduit may have a heater wire that heats the gas flow that flows to the patient. As disclosed elsewhere herein, the heater wire may be located on a substrate that is molded and bonded (e.g., as part of a PCB) to a molding compound through the substrate. In some embodiments, the heat output of the heater wire is controlled by a controller. The patient respiratory conduit and / or the patient interface may be considered as part of the respiratory assistance device, or alternatively as peripheral to the respiratory assistance device. The respiratory assistance device, the respiratory conduit and the patient interface together may form a respiratory assistance system, or in some configurations a flow therapy system.

[0297] In some embodiments, the controller controls the flow generator to generate a gas flow at a desired flow rate, controls one or more valves to control the mix of air and oxygen or other alternative gas, and controls the humidifier to humidify and / or heat the gas flow to an appropriate level. The gas flow can be directed through a patient breathing conduit and a patient interface to exit to the patient. The controller can also control a heating element in the humidifier (which may also include shaping elements as described elsewhere herein) and / or a heating element in the patient breathing conduit (which may also include shaping elements as described elsewhere herein) to humidify and / or heat the gas to a desired temperature that achieves a desired level of therapy and / or patient comfort. In some embodiments, the controller can be set and programmed with a suitable target temperature for the gas flow, or the controller can determine such a target temperature.

[0298] Operational sensors such as flow, temperature, humidity and / or pressure sensors can be located at various locations in the gas delivery device (e.g., breathing apparatus, insufflation apparatus, etc.) and / or the patient breathing conduit and / or other patient interface (e.g., surgical cannula, etc.). These sensors can be molded and bonded to the molding material via a bonding layer formed between the sensor (and / or the substrate on which the sensor's sensing features reside) and the molding material, as described elsewhere herein. As disclosed elsewhere herein, in some embodiments, the output from the sensor is received by a controller, which helps the controller operate the gas delivery device to provide a targeted therapy. In some configurations, providing a targeted therapy includes meeting or exceeding the patient's inspiratory flow rate. The device can have a transmitter and / or receiver that allows the controller to receive signals from the sensor and / or control various components of the gas delivery device, including, but not limited to, a flow generator, a humidifier and heater wire, or accessories or peripheral devices associated with the breathing assistance device. Each of these features can be molded and bonded to the molding material via a bonding layer. Additionally or alternatively, the transmitter and / or receiver may send data to a remote server or allow remote control of the device.

[0299] In some embodiments, as disclosed elsewhere herein, the humidification chamber according to the embodiments described herein can be adapted for use in a respiratory assistance system to deliver heated humidified gas to a patient, the respiratory assistance system including a respiratory patient interface configured to deliver a flow of respiratory gas received from a gas source, an inlet conduit configured to be in fluid communication with the patient interface and the gas source via a humidifier. In some embodiments, as disclosed elsewhere herein, the humidification chamber (and / or shaped member described throughout this disclosure) can be adapted for use in a gas delivery system to provide gas for a surgical procedure that is not breathable (e.g., for delivering heated and humidified gas to a patient during insufflation), the gas delivery system including a patient interface (e.g., a cannula) configured to deliver a flow of gas received from a gas source, a conduit configured to be in fluid communication with the patient interface and the gas source via a humidifier. The humidifier can include a humidification chamber according to the disclosure above having at least one wall defining a chamber capable of holding a liquid, a chamber inlet, a chamber outlet, and a gas flow path between the chamber inlet and the chamber outlet. The chamber inlet can be configured to be in fluid communication with a gas source, and the chamber outlet can be configured to be in fluid communication with an inhalation conduit. The humidification chamber can hold a volume of liquid (such as water). The humidifier can include a heater plate (e.g., overmolded by the molding material of the chamber and secured via a bonding layer). The heater plate can be configured to heat the volume of liquid and the flow of respiratory gas in the gas flow path in the humidification chamber to heat and humidify the flow of respiratory gas. In some embodiments, the humidifier can also include a controller having one or more hardware processors configured to control an amount of power provided to the heater plate.

[0300] In some embodiments, the humidifiers and methods of use described herein can be used to provide non-invasive and / or invasive therapy. The humidifier can operate in invasive, non-invasive, high flow, or other modes. In some embodiments, the humidifier can operate with a variety of patient interfaces, such as, for example, a tracheostomy tube (ET tube), a full face mask, a nasal mask, a nasal cannula, nasal pillows, sealing prongs, or any other interface. Other desired humidity levels may be possible, and other types of treatment systems can be used. The chamber outlet temperature setpoint can be adjusted according to the therapy provided and the desired humidity level.

[0301] In some embodiments, the respiratory assistance system includes a humidifier, a gas source, a patient interface, and an inhalation conduit configured to transfer respiratory gas from the humidifier to the patient interface. In some embodiments, the gas source and the humidifier may be in separate housings, or may optionally be co-located, in the same housing, and / or included in a single device. In some embodiments, the humidifier comprises a humidification chamber as disclosed elsewhere herein. In some embodiments, the respiratory assistance system includes an optional exhalation conduit configured to transfer gas from the patient interface to the gas source, and an optional Y-piece configured to connect the inhalation conduit and the exhalation conduit to the patient interface. In some embodiments, the respiratory assistance system may not include an exhalation conduit or may include an exhalation port.

[0302] In some embodiments, the gas source includes a ventilator, which may include a blower or alternatively a turbine. The gas source may also include other mechanisms, such as a valve arrangement or a pump, that pump or push the flow of breathing gas to the humidifier. In some embodiments, the gas source is a room or ambient air intake type ventilator. In some embodiments, the gas source may include an inlet through which ambient air is drawn into the gas source, for example by the ventilator. In some embodiments, the gas source may optionally include a controller configured to control the operation of the ventilator, the humidifier, or other components of the respiratory assistance system. In some embodiments, the gas source may optionally include a user interface that may provide information regarding user input to the controller. In some embodiments, the controller may control the operation of the ventilator based on information provided by the user interface and / or based on other information, such as, but not limited to, feedback from the ventilator or humidifier, such as from sensors associated with the ventilator or humidifier. As disclosed elsewhere herein, such sensors may be molded and bonded to the molding material via a bonding layer. In some embodiments, instead of drawing in ambient air, the inlet can be connected to a dry gas supply, such as a gas canister or tank. These types of ventilators can be referred to as non-intake ventilators and can be controlled by one or more valves, such as proportional valves. The one or more valves can be controlled by a controller.

[0303] In some embodiments, the humidifier may include a humidification chamber and a heater plate, as disclosed elsewhere herein. The humidification chamber may be configured to hold a volume of water or other suitable liquid and may include features according to the features of the humidification chamber disclosed above. The heater plate may be configured to heat the volume of water and the respiratory gas in the humidification chamber, which may increase the temperature of the respiratory gas and generate steam from the volume of water that is absorbed by the respiratory gas. In some embodiments, the heater plate may include a molding material and a molded PCB, the molding material and the PCB being connected via a bonding layer, as disclosed elsewhere herein. The humidification chamber may include a chamber inlet and a chamber outlet. An inhalation conduit (or, in some cases, a delivery conduit) may be configured to connect to the chamber outlet, and the heated and humidified respiratory gas (or delivery gas, etc.) may be transported from the humidification chamber to the patient interface by the inhalation conduit and then delivered to the patient. Gas exhaled by the patient into the patient interface may optionally be returned to the gas source by the expiratory conduit. The respiratory assistance system may not include an expiratory conduit, and therefore gases exhaled by the patient into the patient interface may be vented to the atmosphere, either directly or optionally through an expiratory port.

[0304] In some embodiments, the humidifier may include a controller that may control, for example and without limitation, the operation of the heater plate. If the humidifier and the gas source form an integrated device, the controller may be the same hardware processor or a separate processor. In some embodiments, the humidifier may also include a user interface that provides and / or receives information regarding user input to the controller. In some embodiments, the humidifier may further include an inlet temperature sensor. In some embodiments, the inlet temperature sensor may be configured to detect the temperature of the gas entering the humidifier. In some embodiments, the inlet temperature sensor may measure a characteristic of the ambient air near the location of the inlet temperature sensor, such as the temperature of the ambient air. In some embodiments, the inlet temperature sensor may also be a temperature sensor located at or near the chamber inlet. In some embodiments, the temperature sensor at the chamber inlet may optionally measure both the temperature and flow rate of the air coming out of the gas source. This measurement may indicate ambient conditions. Additionally and / or alternatively, the respiratory assistance system may include two or more sensors located at or near the chamber inlet. In some embodiments, the inlet sensor may include a temperature sensor and a separate flow rate sensor. In some embodiments, the inlet sensor(s) can be located anywhere from the gas source 1902 to the humidification chamber. In some embodiments, the outlet sensor(s) and the inlet sensor(s) can be coupled with a molding material of the humidification chamber. In some embodiments, for example, the sensors can be provided on a PCB (or other substrate) that can be molded with the molding material. In some embodiments, the molding material is attached to the substrate (or some portion of the sensor) via a bonding layer as disclosed elsewhere herein. In some embodiments, the controller can receive information from the inlet temperature sensor regarding characteristics of the ambient air near the location of the inlet temperature sensor.The controller can be configured to control the operation of the heater plate based on information provided by the user interface, based on information provided by the inlet temperature sensor, and / or based on other information, such as feedback from the heater plate, such as, but not limited to, from a temperature sensor located at or near the heater plate. As disclosed elsewhere herein, in some embodiments where a PCB-based heating element is used, the temperature sensor can be on the same PCB as the heating element. In some embodiments, the controller can be configured to determine an amount of power or power duty cycle to provide to the heater plate such that the heater plate delivers a desired amount of heat to the respiratory gas and volume of water in the humidification chamber.

[0305] In some embodiments, the respiratory assistance system (or other gas delivery system, such as an insufflation system) may include one or more outlet sensors associated with the chamber outlet location. In some embodiments, the one or more outlet sensors may also be located at or near the chamber outlet. In some embodiments, the outlet sensor may include two sensors: a temperature sensor and a flow sensor. In some embodiments, the temperature sensor may be a thermistor (such as a heated thermistor). In some embodiments, the thermistor may also be used as a flow sensor. Thus, there may be a single sensor at or near the chamber outlet. Other types of temperature and flow sensors that may function in the respiratory assistance system may also be used. In some embodiments, the outlet sensor may be located at the chamber outlet, in the inhalation conduit (or patient interface conduit) near the connection between the chamber outlet and the inhalation conduit, or in another suitable location downstream of the humidification chamber. In some embodiments, the controller may receive information from the outlet sensor regarding characteristics of the respiratory gas flowing past the location of the outlet sensor. In some embodiments, the controller may be configured to control the operation of the heater plate based on information provided by the outlet sensor instead of or in addition to other sources of information such as those described above. The outlet sensor can be integrated (e.g., molded) into the heater base or can be located on a cartridge that is removably attachable to the vertical portion of the heater base. In some embodiments, the sensor can be insertable into the inlet and outlet ports when the chamber is positioned in an operating position on the heater base. In some embodiments, the chamber inlet and chamber outlet can include openings that correspond to and receive the inlet temperature sensor and the outlet sensor. The sensor opening of the chamber can include a polymer cover configured to cover the sensor tip when inserted into the gas path such that the sensor does not need to be sterilized because the sensor does not actually contact the gas.The sensor may be bonded to the molding material of the chamber, walls and / or conduits, as disclosed elsewhere herein, and may be attached to the molding material by one or more bonding layers.

[0306] As disclosed elsewhere herein, breathing gas (or surgical gas for insufflation or other surgical applications) flowing through the inhalation conduit may lose heat through the walls of the inhalation conduit, which may reduce the temperature of the breathing gas and may cause condensation within the inhalation conduit (or patient interface conduit). In some embodiments, the inhalation conduit (or patient interface conduit) may include a conduit heater configured to heat the conduit to reduce or prevent this heat loss. In some embodiments, the conduit heater may be coupled to the molding material of the conduit via a bonding layer, as disclosed elsewhere herein. In some embodiments, the controller may be configured to control operation of the conduit heater based on one or more sources of information, such as those described above. In some embodiments, the controller may be configured to determine an amount of power or power duty cycle to provide to the conduit heater such that the conduit heater delivers a desired amount of heat to the conduit. The conduit heater may be disposed within the wall of the conduit or may be disposed within the lumen of the conduit.

[0307] In some embodiments, the respiratory assistance system may include one or more conduit sensors located in the inhalation conduit (or interface conduit). In some embodiments, the conduit sensor may be located in the conduit near the connection of the conduit to the Y-piece (if present), at the connection of the inhalation conduit to the patient interface if the conduit is directly connected to the patient interface, or at the Y-piece or the patient interface. The conduit sensor may measure a characteristic of the gas flowing past the conduit sensor location, such as the temperature of the gas. The conduit sensor may include a temperature sensor. In some embodiments, the conduit sensor may also include a separate flow sensor. In some embodiments, the conduit sensor may include an integrated flow and temperature sensor that may measure both temperature and flow, such as those described herein. In some embodiments, the controller may receive information regarding the characteristic of the gas flowing past the conduit sensor location from the conduit sensor. In some embodiments, the controller may determine the flow rate of the gas flowing past the conduit sensor. In some embodiments, the controller may be configured to control the operation of the conduit heater and / or the operation of the heater plate based on information received from the conduit sensor instead of or in addition to the other sources of information discussed above. In some embodiments, the conduit sensor can be embedded within the conduit and extend into the gas path defined by the conduit. Additionally, the wires of the conduit sensor can be embedded within the wall of the conduit or extend along the conduit. As disclosed elsewhere herein, the sensor can be part of a PCB that is bonded to the molding compound by one or more bonding layers.

[0308] In some embodiments, the gas may also lose heat through the walls of the patient interface, the Y-piece, and / or any other system components that may connect the patient interface to the inhalation conduit (or patient interface conduit). The patient interface, the Y-piece, and / or any other system components that may connect one or more of the patient interfaces to the conduit may include an associated heater and / or an associated sensor. In some embodiments, the heater and / or the associated sensor are provided on a PCB that is bonded to the bonding material by a bonding layer as disclosed elsewhere herein. In some embodiments, the controller may receive information from such associated sensors regarding characteristics of the breathing gas flowing past the sensor location. In some embodiments, the controller may use information received from such associated sensors to control the operation of the respective associated heater. In some embodiments, the heater and / or sensor may be bonded to the molding material by one or more bonding layers to form a molding member as disclosed elsewhere herein, and the molding member may be coupled to the chamber, the wall, and / or the conduit.

[0309] In some embodiments, one or more of the patient interface, the Y-piece, and any other system components that may connect the patient interface to a conduit may not include an associated heater and / or an associated sensor.

[0310] In some embodiments, the humidifier can be used in any respiratory support system to deliver heated and humidified respiratory gas to a patient for multiple types of respiratory therapy, including but not limited to invasive ventilation, non-invasive ventilation, high-flow therapy, BiPaP therapy, continuous positive airway pressure, or other respiratory support therapy. The humidity condition of the respiratory gas provided by the gas source to the humidifier can be modified. For example, the type of gas source used in the respiratory support system may depend on the type of respiratory therapy, the breathing system configuration, the location of use (such as home or hospital), or the availability of different gas supplies. Gas from different supplies may have different characteristics, including temperature and humidity. Ambient air, especially in tropical weather and / or during summer months, may have higher humidity than gas obtained from compressed gas tanks or bottles. It may be beneficial to adjust the operating parameters of the respiratory support system using a control system so that the patient receives comfortable care, for example, with reduced and / or minimal rainout at the inspiratory tract and / or patient interface, while still adequately receiving humidified gas despite the characteristics of the different supply gases. The control system may be able to automatically adjust the operating parameters based on an inference that the supply gas is dry or ambient air. The operating parameters may include some temperature set point. Additionally or alternatively, the operating parameters may be dew point, humidity output of a humidifier, or other suitable parameters. Additionally, high flow therapy may create a flushing effect in the nasal pharynx such that the anatomical dead space of the upper airway is flushed by the incoming high flow gas stream. This provides a reservoir of fresh gas available for every breath while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0311] The patient interface may be a non-sealing interface that prevents barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere). The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface.

[0312] Several embodiments of humidification chambers have been described and illustrated herein. Although specific embodiments have been described, the disclosure is not intended to be limited to those specific embodiments, as the disclosure is as broad as the art allows, and it is intended that the specification be read in the same manner. Thus, although specific types of inlet configurations / arrangements, outlet configurations / arrangements, heater plates, heating elements, numbers, sizes, shapes, etc. for the humidification chambers have been disclosed, it will be understood that any suitable combination of these features can be used to provide the humidification chamber. Furthermore, although specific types of configurations / arrangements, heater plates, heating elements, numbers, sizes, shapes, etc. for the humidification chambers, etc. have been disclosed, it will be understood that other types can be used. Thus, it will be understood that those skilled in the art can make still other modifications to the disclosed embodiments without departing from the spirit and scope of those disclosed or claimed.

[0313] In any of the embodiments described herein, the shape of the heater for the humidifier is not limited. The flexible heating element can be formed into any shape, including flat, folded or curved, according to the need for a particular location and / or condition. The microchannels can also be surface structures that affect or direct the flow of gas / air and water / liquid. The orientation of the channels and structures is not limited and can be designed according to any particular need. The pattern and arrangement of the channels and structures is also not limited.

[0314] As disclosed elsewhere herein, in some embodiments, the bonding layer disclosed herein prevents or retards the peeling of thermoplastic resin from substrate.In some embodiments, the life span of the molding material disclosed herein (relative to conventional molding materials that do not contain silicon-containing linker) is improved and / or extended by about 1.25 times, 1.5 times, 1.75 times, 2 times, 5 times, 10 times, 20 times, 40 times, or more than the range including and / or ranging above the above values.Peel strength can also be used as a measure to demonstrate the improved properties of the embodiments of the molding material disclosed herein (relative to conventional molding materials that do not contain silicon-containing linker bonding layer). In some embodiments, using an Instron peel strength apparatus and a 90 degree peel angle at 50 mm / min, the molding members disclosed herein have improved peel strengths (compared to a matched conventional plasma-treated control that does not contain a silicon-containing linker and / or a control that is not plasma-treated and does not have a silicon-containing linker) of about 2.5 N / mm, 5 N / mm, 10 N / mm, 20 N / mm, 40 N / mm, 60 N / mm, 80 N / mm, 100 N / mm, 150 N / mm, or a range including and / or ranging from the values ​​mentioned above (compared to a matched conventional plasma-treated control that does not contain a silicon-containing linker). In some embodiments, using these peel test parameters, the molding members disclosed herein have peel strengths of about 2.5 N / mm, 5 N / mm, 10 N / mm, 20 N / mm, 40 N / mm, 60 N / mm, 70 N / mm, 100 N / mm, 150 N / mm, 200 N / mm, 250 N / mm, or a range including and / or ranging from the values ​​mentioned above. In some embodiments, using these peel test parameters, the molding materials disclosed herein undergo cohesive failure in addition to or instead of adhesive failure.

[0315] For the sake of brevity, in some embodiments disclosed herein, a molded member may be disclosed as being one of an overmolded or an insert molded member (and / or prepared by either of these methods). When one of these terms is used, it should be understood that injection molding is also more generally envisioned, as injection molding can be overmolded or insert molding. Thus, even when embodiments are disclosed as being overmolded, they may more generally be injection molded. Also, when embodiments are disclosed as being overmolded, they may be insert molded. Also, for the sake of brevity, in some embodiments disclosed herein, reference is made to a respiratory device when discussing, for example, housings for filters, gas conduits, gas flow chambers, chambers, tube connectors, tube fittings, tube elbows, heating elements, PCBs, water infusion components, humidification chambers, etc. However, it should be understood that the description of any of these parts, components, and combinations thereof is also applicable to apparatus and components that deliver surgical gases (e.g., insufflation apparatus, etc.). Thus, even when embodiments are disclosed with respect to a respiratory apparatus, they may also be used with insufflation devices. Similarly, where embodiments are disclosed with respect to an insufflation apparatus, those embodiments may also be used with breathing devices. EXAMPLES

[0316] Example 1 (FIG. 45): Silanization of epoxy-containing silanes via wet chemistry The PCB substrate was subjected to oxygen plasma treatment using a low-pressure plasma chamber to activate the surface. When the surface was oxidized, reactive species such as -OH and -COOH were generated on the surface. An epoxy ring-containing silane coupling agent, 3-glycidoxypropyltrimethoxysilane (GPTMS), was attached to the PCB surface by a wet chemical process.

[0317] Example 2 (FIG. 46): Silanization of amine-containing silanes via wet chemistry An amine-containing silane coupling agent, 3-aminopropyltrimethoxysilane (APTMS), was attached to the PCB surface by wet chemistry, followed by activation of the PCB surface using oxygen plasma treatment.

[0318] Example 3 (FIG. 47): Bonding of thermoplastic material to PCB Thermoplastic polymers, Surlyn® 9020 ionomer and Nucrel® AE were overmolded onto the PCB substrate. Surlyn® 9020 is a modified ethylene / methacrylic acid (E / MMA) copolymer in which the MMA groups are partially neutralized with zinc ions. Nucrel® AE is a terpolymer of ethylene, methacrylic acid and acrylates. The epoxy rings on the GPTMS on the PCB surface can be opened and crosslinked by the carboxyl groups in Surlyn® and Nucrel®.

[0319] Example 4 (FIG. 48): Bonding of thermoplastic material to PCB Three amine-containing thermoplastics were attached to the silane-modified PCB surface. Desmopan® 9370A, a polyurethane; Pebax® MV1074, a block copolymer of polyamide and polyether; and Nylon Ultramid® B3S, a polyamide 6, are thermoplastics that contain secondary amine groups. The amine groups in Desmopan®, Pebax®, and Nylon reacted with the epoxy groups on the GPTMS to form covalent bonds.

[0320] Example 5 (FIG. 49): Bonding of thermoplastic material to PCB Elvaloy® PTW is an ethylene terpolymer consisting of ethylene / butyl acrylate / glycidyl methacrylate terpolymer (E / BA / GMA), and Lotader® AX8840 is a random copolymer of ethylene and glycidyl methacrylate. The epoxy rings in Elvaloy® and Lotader® can be opened and crosslinked by primary amines from APTMS.

[0321] Example 6 (FIG. 50): Bonding of thermoplastic material to PCB Orevac® 18732, Scona® TPPP9012PA, Modic TM P563 and Fusabond® P613 are propylene functionalized with succinic anhydride. Orevac®, Scona®, Modic TM The succinic anhydride in P563, Fusabond® P613, can be ring-opened and crosslinked by the primary amine from APTMS.

[0322] The combinations of silane coupling agents and molding materials are summarized in Table 1.

[0323] [Table 1]

[0324] Example 7 (FIG. 51): Bonding of thermoplastic material to PCB Visico, a cross-linked polyethylene (PEX) TM / Ambicat TM and Dynasylan®, a silane-crosslinkable polyolefin resin, Linklon®. TM are based on silane copolymer technology. They can crosslink with tetramethoxysilane (TMOS) or tetraethoxysilane (TEOS) modified PCBs. A summary of silicon alkoxide and PEX combinations is listed in Table 2.

[0325] [Table 2]

[0326] Example 8: Preparation and testing of molded parts General silane preparation procedure Below, we outline a general method for preparing reactive coupling silanols from silanes and functionalizing substrates (e.g., PCBs) with those reactive silanols. As disclosed below, these reactive coupling silanols can be used to prepare substrates functionalized with silane coupling linkers.

[0327] The generic ingredients include silane, deionized water, 5% acetic acid, and methanol or ethanol. Generally, a 2% silane-methanol solution was prepared for coating the PCB. Alternatively, the silane can be prepared based on the intended concentration of linker on the PCB coating, adjusted based on the molecular weight and density of the silane. Water was used to achieve hydrolysis of the silane. Calculations were used to determine the minimum water requirement for preparation of reactive silanols for functionalization of each silane to the PCB substrate. While the hydrolysis of some silanes can be slow at neutral pH values, such silanes can benefit from the use of an acid catalyst to accelerate hydrolysis. Aminosilanes are alkaline in nature and do not require a catalyst to catalyze the hydrolysis. The procedure for preparing reactive silanols was as follows: add the specified amount of water, add the silane, add enough 5% acetic acid to change the pH to 4-5 (if a catalyst is desired), and add methanol to achieve the desired volume and concentration. For example, to prepare 50 mL of silanol solution from a trialkoxysilane, 3 equivalents of water and 1 equivalent of silane were added to a 50 mL volumetric flask. Acetic acid was added to achieve a pH of 4-5. The solution was then diluted to 50 mL using methanol.

[0328] Epoxide-based silanes (3-Glycidoxypropyl)trimethoxysilane (GPTMS) - Product code: SIG5840.0 [ka] Molecular weight - 236.34 g / mol; density - 1.07 g / mL; 2% GPTMS = 1 mL in 50 mL solution. 1 mL GPTMS = 1.07 g / mL x 1 = 1.07 g; 1.07 g GPTMS / 236.34 g / mol = 0.00453 mol; GPTMS:H2O = 1:3 (trimethoxysilane); minimum amount of water is 0.00453 x 3 = 0.0136 x 18.015 g / mol = 0.245 g.

[0329] To prepare a solution for functionalization of the substrate, add 0.245 mL of water (e.g., 0.245 g water) to a 50 mL volumetric flask. Add 1 mL of GPTMS to the water. The solution was acidified to pH 4-5 with 5% acetic acid, and the resulting solution was diluted to 50 mL with methanol.

[0330] Amine Silanes Aminopropylsilsesquioxane in aqueous solution, 25% (WSA-9911) - Product code: WSA-9911 [ka] 4 mL of a 25% concentration aqueous solution of WSA-9911 (eg, 1 mL of WSA-9911) was added to a 50 mL flask and diluted to 50 mL with methanol.

[0331] Bis(3-triethoxysilylpropyl)amine, 95% (SIB1824.5) - Product code: SIB1824.5 [ka] Molecular weight of SIB1824.5 - 425.71 g / mol; density - 0.97 g / mL; 2% SIB1824.5 = 1 mL in 50 mL solution; 1 mL SIB1824.5 x 0.97 g / mL = 0.97 g; 0.97 g of SIB1824.5 / 425.71 g / mol = 0.00228 mol; SIB1824.5:H2O = 1:6 (bipodial); the minimum amount of water is 0.00228 x 6 = 0.0137 x 18.015 g / mol = 0.247 g.

[0332] To prepare a solution for functionalization of the substrate, 0.247 mL of water was added to a 50 mL volumetric flask. To the water, 1 mL of SIB1824.5 was added. The solution was acidified to pH 4-5 with 5% acetic acid, and the resulting solution was diluted to 50 mL with methanol.

[0333] Bis(3-trimethoxysilylpropyl)amine, 96% (SIB1833.0) - Product code: SIB1833.0 [ka] Molecular weight - 341.56 g / mol; density - 1.04 g / mL; 2% SIB1833.0 = 1 mL in 50 mL solution; 1 mL SIB1833.0 x 1.04 g / mL = 1.04 g; 1.04 g of SIB1833.0 / 341.56 g / mol = 0.00304 mol; SIB1833.0:H2O = 1:6 (bipodial); the minimum amount of water is 0.00304 x 6 = 0.0182 x 18.015 g / mol = 0.328 g.

[0334] To prepare a solution for functionalization of the substrate, 0.328 mL of water was added to a 50 mL volumetric flask. To the water, 1 mL of SIB1833.0 was added. The resulting solution was diluted to 50 mL with methanol.

[0335] Succinic anhydride silane (3-Triethoxysilyl)propylsuccinic anhydride, 95% (TEPSA) - Product code: SIT8192.6 [ka] Molecular weight - 304.41 g / mol; density - 1.07 g / mL; 2% TEPSA = 1 mL in 50 mL solution; 1 mL TEPSA x 1.07 g / mL = 1.07 g; 1.07 g of TEPSA / 304.41 g / mol = 0.00351 mol; TEPSA:H2O = 1:3 (trialkoxysilane); minimum amount of water is 0.00351 x 3 = 0.0105 x 18.015 g / mol = 0.190 g.

[0336] To prepare a solution for functionalization of the substrate, 0.190 mL of water was added to a 50 mL volumetric flask. To the water, 1 mL of TEPSA was added. The solution was acidified to pH 4-5 with 5% acetic acid, and the resulting solution was diluted to 50 mL with methanol.

[0337] TEOS / TMOS Tetraethoxysilane, 98% (TEOS) - Product code: SIT7110.0 [ka] Molecular weight - 208.33 g / mol; density - 0.9335 g / mL; 2% TEOS = 1 mL in 50 mL solution; 1 mL TEOS x 0.9335 g / mL = 0.9335 g; 0.9335 g / 208.33 g / mol = 0.00448 mol of TEOS; TEOS:H2O = 1:4 (tetraalkoxysilane); minimum amount of water is 0.00448 x 4 = 0.0179 x 18.015 g / mL = 0.323 g.

[0338] To prepare a solution for functionalization of the substrate, 0.323 mL of water was added to a 50 mL volumetric flask. To the water, 1 mL of TEOS was added. The solution was acidified to pH 4-5 with 5% acetic acid, and the resulting solution was diluted to 50 mL with methanol.

[0339] Tetramethoxysilane, 98% (TMOS) - Product code: SIT7510.0 [ka] Molecular weight - 152.22 g / mol; density - 1.032 g / mL; 2% TMOS = 1 mL in 50 mL solution; 1 mL TMOS x 1.032 g / mL = 1.032 g; 1.032 g of TMOS / 152.22 g / mol = 0.00678 mol; TMOS:H2O = 1:4 (tetralkoxysilane); minimum amount of water is 0.00678 x 4 = 0.0271 x 18.015 g / mL = 0.488 g.

[0340] To prepare a solution for functionalization of the substrate, 0.488 mL of water was added to a 50 mL volumetric flask. To the water, 1 mL of TMOS was added. The solution was acidified to pH 4-5 with 5% acetic acid, and the resulting solution was diluted to 50 mL with methanol.

[0341] Plasma treatment of substrates To prepare a plasma treated substrate (e.g., PCB), the following general procedure was performed: The PCB (or other substrate) is plasma treated using a Plasmaetch PE-25. The following conditions were used: Oxygen pressure: 20 PSI from the oxygen tank regulator; Treatment time: 15 minutes; Power level: High; Oxygen flow rate: Approximately zero; Vacuum pressure: 110 mtorr.

[0342] Substrate functionalization with silanols To prepare the silane coated su...

Claims

1. a gas flow path having an interior region, the gas flow path having an inlet configured to receive gas into the interior region of the gas flow path and an outlet configured to allow passage of the gas from the interior region of the gas flow path; a heater having a heating surface disposed between the inlet and the outlet of the gas flow path, the heater heating a humidification liquid received by the heating surface to humidify the gas flowing through the gas flow path; a printed circuit board (PCB) having a heating track, the PCB having at least one electrical contact; a molding material disposed over at least a portion of the PCB; a tie layer comprising a silicon-containing linker, the tie layer coupling at least a portion of the molding material to the PCB; A heater comprising: Equipped with A respiratory humidification device configured to provide humidified gas to a patient.

2. 2. A respiratory humidification device as described in claim 1, wherein the PCB spans a portion of the gas flow path from the internal region to a region external to the gas flow path, a portion of the PCB is exposed in the external region, and a portion of the PCB is in thermal communication with the internal region of the gas flow path.

3. A respiratory humidification device as described in claim 1 or 2, wherein the PCB comprises one or more electrical components configured to receive, transmit and / or process information regarding the status of the respiratory humidification device and / or the gas flow path.

4. A respiratory humidification device according to any preceding claim, wherein the PCB comprises one or more temperature sensors in thermal communication with the interior region of the gas flow path.

5. A respiratory humidification device according to any one of claims 1 to 4, wherein the PCB comprises two or more temperature sensors, at least one of the temperature sensors being configured to measure the temperature of the heated surface.

6. A respiratory humidification device according to any one of claims 1 to 5, wherein the PCB comprises a temperature sensor configured to detect whether the heated surface is wetted by the humidification liquid in at least one area.

7. A respiratory humidification device according to any one of claims 4 to 6, wherein at least one temperature sensor is located at, on, adjacent or in close proximity to the heated surface.

8. A respiratory humidification device as described in any one of claims 1 to 7, wherein the PCB comprises one or more of a pressure sensor, a flow sensor and / or a humidity sensor, the one or more of the pressure sensor, the flow sensor and / or the humidity sensor configured to detect a parameter of gas in the gas flow path.

9. A respiratory humidification device according to any preceding claim, wherein the PCB comprises a fluid level sensor and / or a liquid sensor.

10. A respiratory humidification device according to any preceding claim, wherein the heated track of the PCB is in thermal communication with the interior region of the gas flow path.

11. 11. A respiratory humidification device according to claim 10, wherein the heated tracks of the PCB are covered by the molding compound and are in thermal communication with the interior region of the gas flow path through the molding compound.

12. A respiratory humidification device according to claim 10 or 11, wherein the heated surface comprises a portion of the moulding material covering the heating track.

13. A respiratory humidification device as described in any one of claims 3 to 12, wherein the molding material covers one or more of the electrical components and / or sensors of the PCB, and the molding material isolates the one or more of the electrical components and / or sensors from direct contact with the internal area of ​​the gas flow passage.

14. 14. A respiratory humidification device according to claim 13, wherein a moulding material is configured to enable monitoring of the interior area of ​​the gas flow passage by the electrical components of the PCB and / or the sensor through the moulding material.

15. A respiratory humidification device according to any preceding claim, comprising a humidification liquid inlet for supplying the humidification liquid from a reservoir to the heater.

16. A respiratory humidifier device according to any preceding claim, comprising a humidification liquid pre-heater.

17. A respiratory humidification device according to any preceding claim, comprising a humidification liquid flow controller.

18. 18. Respiratory humidification device according to claim 17, wherein the liquid flow controller comprises a metering system and / or a pump.

19. A respiratory humidification apparatus according to any preceding claim comprising a gas pre-heater.

20. A respiratory humidifier device according to any preceding claim, wherein the moulding material comprises a thermoplastic material.

21. A respiratory humidifier device according to any preceding claim, wherein the moulding material comprises a thermosetting material.

22. A respiratory humidifier device according to any preceding claim, wherein the moulding material encapsulates at least a part of the PCB.

23. 23. A respiratory humidification device according to claim 22, wherein the portion of the PCB encapsulated by the molding compound includes a portion of the heating track.

24. 24. A respiratory humidification device according to claim 22 or 23, wherein the moulding material provides a barrier between the PCB and the gas flow path.

25. A respiratory humidification device according to any preceding claim, wherein the at least one electrical contact of the PCB is not encapsulated and / or covered by the moulding compound.

26. A respiratory humidification device according to any preceding claim, wherein a portion of the moulding material is provided with microchannels and / or surface structures.

27. 27. A respiratory humidification device as described in claim 26, wherein the microchannels and / or surface structures are configured to receive, distribute and / or retain the humidification liquid such that the humidification liquid can be heated by the heating track.

28. A respiratory humidification device according to any preceding claim, wherein a portion of the moulding material is configured to receive and hold the humidification liquid such that the humidification liquid can be heated by the heating track.

29. 29. A respiratory humidification device according to claim 28, wherein the portion of molding material configured to receive the humidification liquid is coupled to the PCB by the bonding layer.

30. A respiratory humidifier device according to any one of the preceding claims, wherein the moulding material is hydrophilic or hydrophobic.

31. A respiratory humidification device according to any preceding claim, wherein the bonding layer chemically couples the moulding material to the portion of the PCB.

32. 1. A heater for a humidification chamber, comprising: a heating component comprising a heating track and a substrate, the heating track being disposed on the substrate; a molding material disposed over at least a portion of the heating component; a bonding layer coupling at least a portion of the molding material to the heating element; Equipped with A heater, wherein the bonding layer comprises a silicon-containing linker.

33. 33. The heater of claim 32, wherein the bonding layer is a separate layer from the molding material and the heating component.

34. A heater according to any one of claims 32 to 33, wherein the tie layer chemically couples the moulding material to the portion of the heating component.

35. A heater as claimed in any one of claims 32 to 34, wherein the bonding layer comprises one or more of covalent bonds, hydrogen bonds, van der Waals forces and / or ionic bonds connecting the moulding material to the portion of the heating component.

36. 36. The heater of any one of claims 32-35, wherein the bonding layer is formed through a reaction between one or more of an epoxy ring, an amine, a succinic anhydride, a methoxyl, or an ethoxyl moiety and one or more of a carboxyl, an amine, an epoxy ring, a succinic anhydride, or a reactive silanol moiety.

37. The heater of any one of claims 32-36, wherein the tie layer is formed, at least in part, through a reaction between succinic anhydride moieties and amine moieties.

38. The heater of any one of claims 32-36, wherein the tie layer is formed, at least in part, through a reaction between succinic anhydride moieties and secondary amine moieties.

39. The silicon-containing linker is 【Chemistry 1】 or a polymerized silane coupling linker thereof, During the ceremony, ＊＊ is a bonding point to the molding material, Each R' is selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy and -O- ＊ are individually selected from the group consisting of ＊ is a point of attachment to the heating component, and at least one of the R's is -O- ＊ and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; -L- ＊＊ but, 【Chemistry 2】 is selected from the group consisting of -L''- ＊＊ but, 【Chemistry 3】 The heater according to any one of claims 32 to 38, selected from the group consisting of:

40. The silicon-containing linker is 【Chemistry 4】 or a polymerized silicon alkoxy linker thereof, In the formula, R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxyl, —O— ＊ Or -O- ＊＊ and ＊ is a connection point to the heating element; ＊＊ is a bond point to the molding material, and at least one of the R″ is —O— ＊ and at least one of the R″ is —O— ＊＊ and 36. The heater of any one of claims 32 to 35, wherein Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

41. The silicon-containing linker is 【Chemistry 5】 and polymerized siloxane linkers thereof, wherein each Z is independently hydroxy or -O- ＊ and ＊ is a connection point to the heating element; Each Z' is selected from the group consisting of epoxy, primary and secondary amines, succinic anhydride and -L- ＊＊ is selected from the group consisting of ＊＊ is a bond point to the molding material; -L- ＊＊ but, 【Chemistry 6】 is selected from the group consisting of Z″ is hydrogen or -L″- ＊＊ and -L''- ＊＊ but, 【Chemistry 7】 is selected from the group consisting of ＊＊ is a bond point to the molding material; At least one of the Z's is -O- ＊ and at least one of the Z' is -L- ＊＊ or at least one of said Z'' is -L''- ＊＊ and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl or a C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- ＊ Or -O- ＊＊ and ＊ is a connection point to the heating element; ＊＊ is a bond point to the molding material, and at least one of the Z''' is -O- ＊ and at least one of said Z''' is -O- ＊＊ and m is an integer greater than 1; A heater according to any one of claims 32 to 38, wherein n is an integer greater than 1.

42. A heater according to any one of claims 32 to 41, wherein the heating component is a printed circuit board (PCB).

43. A heater according to any one of claims 32 to 42, wherein the moulding material comprises a thermoplastic material.

44. 44. The heater of claim 43, wherein the thermoplastic material comprises an overmolded thermoplastic material.

45. A heater according to any one of claims 32 to 36 or 42, wherein the moulding material comprises a thermosetting material.

46. 46. ​​The heater of claim 45, wherein the thermoset material comprises one or more of a silicone rubber, an epoxy, and a polyurethane.

47. A heater according to any one of claims 32 to 46, wherein the moulding material comprises microchannels and / or structural features.

48. A heater according to any one of claims 32 to 47, wherein the moulding material is hydrophilic or hydrophobic.

49. A heater according to any one of claims 32 to 48, wherein the heating track is configured to heat humidification liquid when in thermal communication with the heating component, causing the humidification liquid to vaporize into the gas flow path.

50. a heating component comprising a heating track provided on a substrate; a molding material encapsulating a portion of the heating component, the portion of the heating component being separated from an interior region of the humidification chamber by the molding material; and a bonding layer coupling a portion of the molding material to a portion of the heating element; 16. A heater for a humidification chamber comprising:

51. 51. The heater of claim 50, wherein the bonding layer is a separate layer from the molding material and the heating component.

52. A heater according to any one of claims 50 to 51, wherein the bonding layer comprises a silicon-containing linker layer.

53. A heater as claimed in any one of claims 50 to 52, wherein the tie layer chemically couples the moulding material to the heating component.

54. 54. A heater as claimed in any one of claims 50 to 53, wherein the bonding layer comprises one or more of covalent bonds, hydrogen bonds, van der Waals forces and / or ionic bonds connecting the moulding material and the portion of the heating component.

55. 55. The heater of any one of claims 50-54, wherein the bonding layer is formed at least in part through a reaction between one or more of an epoxy ring, an amine, a succinic anhydride, a methoxyl, or an ethoxyl moiety and one or more of a carboxyl, an amine, an epoxy ring, a succinic anhydride, or a reactive silanol moiety.

56. The heater of any one of claims 50 to 55, wherein the tie layer is formed at least in part through a reaction between succinic anhydride moieties and amine moieties.

57. The heater of any one of claims 50 to 55, wherein the tie layer is formed at least in part through a reaction between succinic anhydride moieties and secondary amine moieties.

58. The silicon-containing linker is 【Chemistry 8】 or a polymerized silane coupling linker thereof, During the ceremony, ＊＊ is a bonding point to the molding material, Each R' is selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy and -O- ＊ are individually selected from the group consisting of ＊ is a point of attachment to the heating component, and at least one of the R's is -O- ＊ and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; -L- ＊＊ but, 【Chemistry 9】 is selected from the group consisting of -L''- ＊＊ but, 【Chemistry 10】 58. The heater of any one of claims 52 to 57, selected from the group consisting of:

59. The silicon-containing linker is 【Chemistry 11】 or a polymerized silicon alkoxy linker thereof, In the formula, R″ is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxyl, —O— ＊ Or -O- ＊＊ and ＊ is a connection point to the heating element; ＊＊ is a bond point to the molding material, and at least one of the R″ is —O— ＊ and at least one of the R″ is —O— ＊＊ and 55. The heater of any one of claims 50 to 54, wherein Y is a single bond, a C1-C8 alkylene, or a C1-C8 heteroalkylene, the C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

60. The silicon-containing linker is 【Chemistry 12】 and polymerized siloxane linkers thereof, wherein each Z is independently hydroxy or -O- ＊ and ＊ is a connection point to the heating element; Each Z' is selected from the group consisting of epoxy, primary and secondary amines, succinic anhydride and -L- ＊＊ is selected from the group consisting of ＊＊ is a bond point to the molding material; -L- ＊＊ but, 【Chemistry 13】 is selected from the group consisting of Z″ is hydrogen or -L″- ＊＊ and -L''- ＊＊ but, 【Chemistry 14】 is selected from the group consisting of ＊＊ is a bond point to the molding material; At least one of the Z's is -O- ＊ and at least one of the Z' is -L- ＊＊ or at least one of said Z'' is -L''- ＊＊ and Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is a C1-C8 alkyl or a C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; Z''' is independently hydroxyl, -O- ＊ Or -O- ＊＊ and ＊ is a connection point to the heating element; ＊＊ is a bond point to the molding material, and at least one of the Z''' is -O- ＊ and at least one of said Z''' is -O- ＊＊ and m is an integer greater than 1; A heater according to any one of claims 50 to 57, wherein n is an integer greater than 1.

61. A heater according to any one of claims 50 to 60, wherein the heating component is a printed circuit board (PCB).

62. 62. The heater of any one of claims 50 to 61, wherein the substrate comprises silicone rubber, ceramic, metal, fiberglass, fiberglass, sized fiberglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, ink, or combinations thereof.

63. A heater according to any one of claims 50 to 62, wherein the moulding material comprises a thermoplastic material.

64. 63. A heater as claimed in any one of claims 50 to 55 or any one of claims 61 or 62, wherein the moulding material comprises a thermosetting material.

65. 65. The heater of claim 64, wherein the thermoset material comprises one or more of a silicone rubber, an epoxy, and a polyurethane.

66. A heater according to any one of claims 50 to 65, wherein the moulding material comprises microchannels and / or structural features.

67. A heater according to any one of claims 50 to 66, wherein the moulding material is hydrophilic or hydrophobic.

68. A heater as claimed in any one of claims 50 to 67, wherein the heating track is configured to heat the humidifying liquid when in thermal communication with the heating component, causing the humidifying liquid to vaporise into the gas flow path.

69. an inlet for receiving gas from a gas source and an outlet for delivering gas to a patient, the inlet and the outlet defining a gas flow path; A heater according to any one of claims 32 to 68 configured to heat and humidify the gas while in the gas flow path; A humidification chamber comprising:

70. Thermoplastic Materials and Substrates Equipped with at least a portion of the substrate is coupled to the thermoplastic material via a silicon-containing linker; the silicon-containing linker is formed at least in part through a reaction between a succinic anhydride moiety and an amine moiety; Molded parts.

71. 1. A method of coupling a thermoplastic material to a substrate, comprising the steps of: providing said substrate having at least one silicon-containing linking agent attached to a surface thereof; contacting the thermoplastic material with the deposited silicon-containing linking agent to form a bond between the thermoplastic material and the substrate; Including, The method, wherein the linkage comprises a reaction product from a reaction between a succinic anhydride moiety and an amine moiety.

72. 72. The shaped member of claim 70 or the method of claim 71, wherein the succinic anhydride moiety is provided on the silicon-containing linker.

73. 73. The molded member of claim 70 or 72 or the method of claim 71 or 72, wherein the amine moieties are provided on the thermoplastic resin.

74. 72. The molded member of claim 70 or the method of claim 71, wherein the amine moiety is provided on the silicon-containing linker.

75. 75. The molding member of claim 70 or 74 or the method of claim 71 or 74, wherein the succinic anhydride moieties are provided on the thermoplastic resin.

76. The molded member of claim 70 or any one of claims 72 to 75, or the method of any one of claims 71 to 75, wherein the amine moieties comprise secondary amine moieties.

77. 77. The method of any one of claims 71 to 76, wherein the step of providing a substrate having at least one silicon-containing linking agent attached to a surface thereof comprises providing the substrate comprising hydroxyls and / or carboxyls on the surface thereof and reacting a silicon-containing linking agent with the hydroxyls and / or carboxyls on the surface of the substrate.

78. 78. The method of claim 77, wherein reacting the silicon-containing linking agent with the hydroxyls and / or carboxyls on the substrate comprises hydrolyzing the silicon-containing linking agent to form a reactive silanol and contacting the reactive silanol with the hydroxyls and / or carboxyls on the substrate.

79. 78. The method of claim 77, wherein reacting a silicon-containing linking agent with the hydroxyls and / or carboxyls on the substrate comprises plasma enhanced chemical vapor deposition (PECVD).

80. 80. The method of any one of claims 77 to 79, wherein providing the substrate comprising hydroxyls and / or carboxyls on the surface further comprises activating the substrate surface by plasma treatment, corona discharge, ozone treatment, chemical treatment or flame treatment.

81. The molded part according to claim 70 or any one of claims 72 to 80, or the method according to any one of claims 71 to 80, wherein the silicon-containing linking agent is a silane coupling agent.

82. The silane coupling agent is represented by the following formula: 【Chemistry 15】 is represented by In the formula, R １ , R ２ , R ３ , R ４ , R ５ and R ６ are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl, and C1-C8 alkoxy; R in (A1) １ , R ２ and R ３ or R in (A2) １ , R ２ , R ３ , R ４ , R ５ and R ６ at least one of is hydroxyl or C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; 82. The molding member or method of claim 81, wherein X is selected from the group consisting of primary and secondary amines and succinic anhydride.

83. 83. The molded member or method of claim 82, wherein the silane coupling agent is selected from the group consisting of 3-aminopropyltrimethoxysilane (APTMS), 3-aminopropyltriethoxysilane (APTES), (3-triethoxysilyl)propylsuccinic anhydride (TEPSA) and bis(3-trimethoxysilylpropyl)amine.

84. The molded part according to claim 70 or any one of claims 72 to 80, or the method according to any one of claims 71 to 80, wherein the silicon-containing linking agent is a siloxane.

85. The silane coupling agent is represented by the following formula: 【Chemistry 16】 is represented by In the formula, R １ , R ２ , R ３ , R ４ , R ５ and R ６ are each independently selected from the group consisting of hydrogen, halogen, hydroxyl, C1-C8 alkyl, and C1-C8 alkoxy; R in (A5) １ , R ２ , R ３ , R ４ and R ５ At least one of R in (A6) and (A7) １ , R ２ , R ３ , R ４ , R ５ and R ６ and R in (A8). １ and R ２ at least two of are independently hydroxyl or C1-C8 alkoxy; Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N; Y' is C1-C8 alkyl or C1-C8 heteroalkyl containing one or more heteroatoms selected from O and N; X is selected from the group consisting of primary amines, secondary amines, and succinic anhydride; m is an integer of 1 or more, 85. The molding member or method of claim 84, wherein n is an integer equal to or greater than 1.

86. 86. The molding member or method of claim 84 or 85, wherein the siloxane is selected from the group consisting of aminopropyl silsesquioxane, aminoethyl aminopropyl silsesquioxane, aminopropyl silsesquioxane-methyl silsesquioxane, and non-functional siloxanes.

87. A moulded part according to claim 70 or any one of claims 72 to 86, or a method according to any one of claims 71 to 86, wherein the substrate is part of a printed circuit board (PCB).

88. 88. The molded member or method of claim 87, wherein the PCB is rigid.

89. 88. The molding member or method of claim 87, wherein the PCB is flexible.

90. A moulded member or method according to any one of claims 87 to 89, wherein the PCB comprises one or more sensors.

91. 91. The molding member or method of claim 90, wherein the one or more sensors are selected from the group consisting of a temperature sensor, a flow sensor, a pressure sensor, a humidity sensor, and a fluid level sensor.

92. A moulded member or method according to any one of claims 87 to 91, wherein the PCB is provided with a heating element.

93. 93. A moulded member or method according to any one of claims 87 to 92, wherein the PCB is provided with electrical connectors.

94. Molded member comprising a thermosetting material and a substrate Equipped with A respiratory device, wherein at least a portion of the substrate is coupled to the thermosetting material via a silicon-containing linker.

95. The silicon-containing linker has the formula: 【Chemistry 17】 or a polymeric silicon-containing linker thereof; During the ceremony, ＊＊ are bond points to the thermosetting material; Each R' is independently hydrogen, halogen, hydroxyl, C1-C8 alkyl, C1-C8 alkoxy, or -O- ＊ and ＊ is a point of attachment to the substrate, and at least one of the R's is -O- ＊ and -L'- ＊＊ but 【Chemistry 18】 where R is H or C1-C8 alkyl; 【Chemistry 19】 but 【Chemistry 20】 and 95. A respiratory apparatus as claimed in claim 94, wherein Y is a single bond, C1-C8 alkylene, or C1-C8 heteroalkylene containing one or more heteroatoms selected from O and N.

96. 96. A respiratory apparatus as claimed in claim 94 or 95, wherein the thermoset material comprises a -Si-H moiety.

97. 97. A respiratory apparatus according to any one of claims 94 to 96, wherein the thermoset material is a silicone rubber, an epoxy or a polyurethane.

98. A respiratory apparatus according to any one of claims 94 to 97, wherein the shaped part is a housing for a filter, a gas conduit, a chamber, an intake tube, a tube connector, a tube fitting, a tube elbow, a heating element or a patient interface component.

99. A respiratory apparatus as claimed in any one of claims 94 to 98, wherein the thermosetting material is a moulding material on the substrate.

100. A respiratory apparatus as claimed in any one of claims 94 to 99, wherein the moulded member is formed by injection moulding the moulding material around the substrate.

101. A respiratory apparatus as claimed in any one of claims 94 to 99, wherein the moulded member is formed by insert moulding the moulding material around the substrate.

102. A respiratory apparatus according to any one of claims 94 to 99, wherein the moulded member is formed by overmolding the moulding material around the substrate.

103. A respiratory apparatus as claimed in any one of claims 94 to 102, wherein the moulding material comprises microchannels or structures on a surface thereof.

104. A respiratory apparatus according to any one of claims 94 to 103, wherein the substrate comprises a material that can be activated to form hydroxyl groups on the surface.

105. 105. A respiratory apparatus according to any one of claims 94 to 104, wherein the substrate is silicone rubber, ceramic, metal, fiberglass, fibreglass, sized fibreglass, etched foil, filled polymer, epoxy resin, phenol formaldehyde resin, paper or polyester resin, polyester, polyetherimide, polyimide, epoxy, polyethylene, copper, ink or combinations thereof.

106. A respiratory apparatus according to any one of claims 94 to 105, wherein the substrate is part of a printed circuit board (PCB).

107. 107. A respiratory apparatus as claimed in claim 106, wherein the PCB is rigid.

108. 107. A respiratory apparatus as claimed in claim 106, wherein the PCB is flexible.

109. A respiratory apparatus according to any one of claims 106 to 108, wherein the PCB comprises one or more sensors.

110. 110. The respiratory apparatus of claim 109, wherein the one or more sensors include a temperature sensor, a pressure sensor, a flow sensor, a humidity sensor and a fluid level sensor or combinations thereof.

111. A respiratory apparatus according to any one of claims 106 to 110, wherein the PCB comprises a heating element.

112. A respiratory apparatus according to any one of claims 106 to 111, wherein the PCB comprises an electrical connector.

Images