Apparatus for use in a respiratory support system
By introducing a pneumatically connected design for the humidifier chamber, inspiratory tubing, and filter into the respiratory support system, the reusability of the inspiratory tubing is achieved, solving the problem of frequent inspiratory tubing replacement, reducing waste and costs, and improving the maintenance of oxygen saturation and patient safety and comfort.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2016-03-31
- Publication Date
- 2026-03-17
AI Technical Summary
In existing respiratory support systems, inspiratory tubes need to be changed frequently to prevent contamination between patients, resulting in waste and increased costs. At the same time, oxygen saturation is difficult to maintain during intubation, especially in difficult intubation procedures, which may lead to multiple interruptions and health risks.
A respiratory support system kit has been designed, including a humidifier chamber, an inspiratory tubing, a filter, and a patient interface. The kit delivers humidified gas to the patient via pneumatic communication, uses a filter to prevent contamination, and allows the inspiratory tubing to be reused.
It reduces the frequency of inspiratory tube replacement, lowers waste and costs, while improving oxygen saturation maintenance during intubation, thus enhancing patient safety and comfort.
Smart Images

Figure CN112891694B_ABST
Abstract
Description
[0001] This application is a divisional application of the invention patent application entitled "Device for use in a respiratory support system", with an international filing date of March 31, 2016, international application number PCT / IB2016 / 051815, and national application number 201680020286.7. Technical Field
[0002] This disclosure generally relates to methods and / or structures for preventing contamination of breathing circuits by patients, including but not limited to respiratory support kits or kits comprising respiratory support components for providing respiratory support to patients undergoing anesthesia, intubation, or endoscopy. Background Technology
[0003] Patients may lose respiratory function during anesthesia or sedation, or more generally during certain medical procedures. Prior to the procedure, patients can be pre-oxygenated by medical professionals to provide an oxygen saturation reserve; this pre-oxygenation is typically performed using a bag and mask. Once the patient is under general anesthesia, intubation is necessary to provide ventilation. In some cases, intubation is completed within 30 to 60 seconds, but in others, especially if traversing the patient's airway is difficult (e.g., due to cancer, severe injury, obesity, or neck muscle spasm), intubation will take significantly longer. While pre-oxygenation provides a buffer against a drop in oxygen saturation, prolonged intubation procedures require interruptions and re-application of the mask to restore the patient's oxygen saturation to an adequate level. Difficult intubation procedures may involve several interruptions, which is time-consuming and puts the patient at serious health risk. The procedure is usually abandoned after approximately three attempts at intubation.
[0004] Breathing therapy circuits are typically single-use items. Once a patient has used the treatment circuit (e.g., a breathing gas tubing), the tubing is discarded along with the patient interface. One reason for this is to prevent contamination from one patient to another when using the same flow source and / or humidifier.
[0005] Respiratory support systems used in multi-patient settings typically require at least the discarding and replacement of inspiratory tubes and patient interfaces between patients to ensure that the components provided to each patient are clean and uncontaminated by previous users. This is time-consuming and can be harmful in emergencies. It also results in significant waste and increases the overall cost of the procedure, or at least the overall operating cost of the hospital, as the hospital needs to maintain a large inventory of inspiratory tubes. This cost may sometimes be passed on to the patient.
[0006] Humidity allows for the comfortable delivery of gas to the patient at high flow rates, enabling the use of gas flow during the patient's preparation phase while awake.
[0007] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge in the relevant field in any country of the world. Summary of the Invention
[0008] The purpose of disclosing certain embodiments herein is to provide a method or apparatus that can solve one or more of the problems described above, or at least to provide a useful option for the public.
[0009] The purpose of certain embodiments disclosed herein is to provide a device for use in a respiratory support system that will at least partially improve the aforementioned problems or at least provide a useful option for the public or the healthcare industry. An alternative or additional purpose of certain embodiments disclosed herein is to provide a kit for use in a respiratory support system that allows for the reuse of the inspiratory tubing.
[0010] In some configurations, humidified gas can be used for comfortable gas delivery during the patient's sedation phase. Humidity prevents or helps to minimize airway dryness, and thus can prevent or minimize airway damage, and can also improve or help maintain patient comfort while receiving the gas flow delivered to their airway.
[0011] Therefore, according to at least one embodiment disclosed herein, a device or kit for use in a respiratory support system for delivering humidified gas to a user or patient is disclosed. The device or kit includes:
[0012] Humidifier chamber, the humidifier chamber being pneumatically connected to a gas source or configured to be placed in pneumatic communication with the gas source;
[0013] An air intake duct, which is pneumatically connected to the humidifier cavity downstream of the humidifier cavity, or is configured to be placed in pneumatic communication with the humidifier cavity downstream of the humidifier cavity;
[0014] A filter, either pneumatically connected to or configured to be placed downstream of the inhalation conduit in pneumatic communication with it; and
[0015] A patient interface for delivering humidified gas to a user or patient, wherein the patient interface is pneumatically connected to the filter downstream of the filter, or is configured to be placed in pneumatic communication with the filter downstream of the filter.
[0016] In the device or kit, the filter may be coupled to the patient interface, or may be configured to be coupled to the patient interface. In the device or kit, the patient interface may include a patient interface gas conduit, wherein the filter may include a gas inlet port and a gas outlet port, and wherein the gas outlet port of the filter and the patient interface gas conduit may include complementary coupling features to enable the filter to be coupled to the patient interface to provide pneumatic communication between the filter and the patient interface gas conduit, wherein the filter is connected in series with a gas flow path through the patient interface gas conduit. In the device or kit, the complementary coupling features may be detachable from each other to allow the filter to be disconnected from the patient interface gas conduit.
[0017] The filter can be connected to an interface tube (e.g., a patient interface gas conduit) connected to the manifold. The patient interface gas conduit can be a tube or a short section of a conduit. For example, the patient interface gas conduit can be about 20 cm to about 50 cm long, or about 25 cm to about 40 cm long, or about 30 cm to about 35 cm long, or it can be about 32 cm long.
[0018] In the device or kit, the patient interface may include a patient interface gas conduit, wherein the filter may be integrated into the patient interface gas conduit to provide pneumatic communication between the filter and the patient interface gas conduit, wherein the filter is in series with a gas flow path through the patient interface gas conduit. Optionally, in such an arrangement, the gas inlet to such an integrated filter may include a complementary coupling feature. This complementary coupling feature may be provided, for example, by an adapter insert attached to the gas inlet of such an integrated filter component.
[0019] Referring to the complementary connection features described herein, these features may optionally be provided by providing an adapter insert to articles or components that require such complementary connection features to achieve connection and disconnection, or to connect and disconnect (e.g., gas inlets or outlets, such as filters, catheters, or gas inlets leading to patient interfaces). Such adapter inserts are described elsewhere in this specification.
[0020] In the device or kit, the gas inlet port of the filter and the gas outlet port of the inhalation conduit may include complementary coupling features to enable the inhalation conduit to be coupled to the filter to provide pneumatic communication between the inhalation conduit and the filter. In the device or kit, the complementary coupling features of the gas inlet port of the filter and the gas outlet port of the inhalation conduit may be disengaged from each other to enable the inhalation conduit to be disconnected from the filter.
[0021] In the device or kit, the gas inlet port of the intake duct and the gas outlet port of the humidifier chamber may include complementary coupling features to enable the intake duct to be coupled to the humidifier to provide pneumatic communication between the humidifier chamber and the intake duct. In the device or kit, the complementary coupling features of the gas outlet of the humidifier chamber and the gas inlet of the intake duct may be disengaged from each other to enable the intake duct to be disconnected from the humidifier chamber.
[0022] The device or kit may further include a gas delivery conduit pneumatically connected to or configured to be placed in pneumatic communication with the gas source, wherein the humidifier chamber is pneumatically connected to or configured to be placed in pneumatic communication with the gas delivery conduit downstream of the gas delivery conduit. In the device or kit, the gas outlet port of the gas delivery conduit and the gas inlet port of the humidifier chamber may include complementary coupling features that enable the gas delivery conduit to be coupled to the humidifier to provide pneumatic communication between the humidifier chamber and the gas delivery conduit. In the device or kit, the gas outlet port of the gas delivery conduit and the gas inlet port of the humidifier chamber include complementary coupling features that may be detachably connected to each other, allowing the gas delivery conduit to be disconnected from the humidifier chamber.
[0023] In the device or kit, the filter may be one or more of the following: high-efficiency particulate air (HEPA) filter, pleated filter (such as a pleated filter made of glass microfiber), nanofiber filter, sock bag filter, disc filter, spiral filter, filter media block, filter media disc having a filter media flow that flows freely from the disc into and out of the disc in a fluid manner, ceramic filter, fabric filter (e.g., woven silk cloth), porous plastic filter (e.g., plastic powder molded into a porous rigid shape), nonwoven media filter (e.g., dry-molded, wet-molded, or membrane filter).
[0024] The filter may contain filter material.
[0025] The filter material may include one or more of the following materials: pleated paper, nanofibers, cellulose, cotton, wood pulp, glass, glass fiber, glass microfiber, or composite materials, polymers, and metals. The polymers may include polytetrafluoroethylene (PTFE), polycarbonate (PC), acrylic fibers including modified acrylic fibers, synthetic fibers, fluoropolymers, thermoplastic polyurethane (TPU), polyethylene (PE), polyamide, polyester, polypropylene (PP), and nylon. The metals may include galvanized steel, stainless steel, aluminum, and copper.
[0026] The composite material may be composed of the following: polyamide, polyethersulfone, polysulfone, ceramic, carbon, polymer, such as polytetrafluoroethylene (PTFE), polycarbonate (PC), acrylic, synthetic fiber, fluoropolymer, thermoplastic polyurethane (TPU), polyethylene (PE), polyamide, polyester, polypropylene (PP), and nylon.
[0027] The filter or the filter material of the filter may include electrostatic, hydrophilic, or hydrophobic properties or characteristics.
[0028] The patient interface may include a nasal cannula or nasal mask, wherein the nasal cannula or nasal mask includes at least one gas flow path that is pneumatically in communication with the filter, or configured to be placed to be pneumatically in communication with the filter when the filter is attached to the patient interface. In some configurations, the nasal cannula includes at least one nasal delivery element that extends from a flow manifold and is adapted to be placed in one or more nostrils of a user to deliver humidified gas to the user, whether in a sealed or unsealed manner.
[0029] The intake conduit may include a heating element for heating the humidified gas as it travels through the intake conduit.
[0030] The humidifier chamber may include a housing defining a liquid reservoir, a gas inlet port pneumatically connected to the liquid reservoir, a gas outlet port pneumatically connected to the liquid reservoir, and a base, wherein the base is arranged to be positioned on or above a heating element for heating the liquid in the liquid reservoir, and wherein the gas inlet port, the liquid reservoir, and the gas outlet port provide a gas flow path from the gas inlet port through or across the liquid reservoir to the gas outlet port to humidify the gas traveling along the gas flow path.
[0031] The inhalation conduit may further include components adapted to engage with the inhalation conduit and support the inhalation component.
[0032] The inhalation conduit may further include a component adapted to engage with the inhalation conduit, and the component is provided with grippers extending from the body of the component, the grippers being adapted to hold an article and thereby support the inhalation component.
[0033] Optionally, the grippers may be a pair of opposing grippers for holding items, such as sheets or clothing or other items or objects (e.g., medical brackets or parts attached thereto).
[0034] The body of the component may substantially surround the periphery of the conduit or tube in which it is located.
[0035] The grippers of the component can interact with each other in the closed position.
[0036] The body includes a shoulder portion associated with each of the pair of grippers, the shoulder portion providing a surface for actuation by a user.
[0037] The shoulder portion is an enlarged area of the body.
[0038] The dimensions of the shoulder section are determined for actuation by the user's fingers or fingerboard.
[0039] The body is configured to be substantially annular around the outer surface of one or more corresponding tubes or each corresponding tube.
[0040] The component may be a clamp capable of engaging with the outer surface or surface of a conduit or tube (e.g., an inhalation conduit), wherein the clamp further includes a pair of jaws adapted for gripping an article, such that the conduit or tube can be supported when the jaws of the clamp grip the article.
[0041] The component may be described, for example, by PCT / NZ2012 / 000169 (published as WO2013 / 073970), the entire contents of which are incorporated herein by reference.
[0042] The device or kit may be provided as a kit.
[0043] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, an apparatus or kit is provided for delivering humidified gas to a user or patient. In some applications, the patient is under anesthesia and / or has been anesthetized and is not breathing spontaneously. In some applications, the patient is pre-oxygenated before being anesthetized.
[0044] Additionally, a packaging component is disclosed based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein. The packaging component includes a sealed container or bag that houses the equipment or kit outlined in the foregoing aspects.
[0045] The filter, humidifier chamber, inhalation tubing, gas delivery tubing, and patient interface may each be disposed separately in the package (i.e., not connected or integrated). Alternatively, at least some of these components may be disposed together in the package in a connected manner.
[0046] For example, the first kit or package may include "consumable" components such as a gas delivery conduit (i.e., a conduit of the type extending from a gas source to the inlet of a humidifier chamber), a humidifier chamber, an inhalation conduit (i.e., a conduit of the type extending from the outlet or downstream side of the humidifier chamber toward the patient interface), a clamp (i.e., a component of the type that may be attached to or can be attached to the conduit, such as an inhalation conduit, to help support or position the inhalation conduit relative to an article), a filter, an adapter insert (i.e., for facilitating connection between components), and a patient interface (i.e., a patient interface of the type described elsewhere in this specification, but which may include a nasal cannula or nasal mask). It should be understood that the gas delivery conduit may be of the type referred to as a "dryline" because it is not downstream of a humidification device (e.g., a humidifier chamber) that provides humidity to the gas flow toward the patient interface.
[0047] For example, another kit or package may include a "patient" component, such as a "patient" component for use by a single patient and / or for a single use or procedure. A "patient" component is, for example, a patient interface and a filter for connecting to such an interface. In another kit or package, the patient interface and the filter may be housed in entirely different or separate packages for sale independently (e.g., a patient interface and filter sold together), or for providing such combinations of these components to the healthcare industry.
[0048] For example, another kit or package may include components needed when the patient is not receiving humidified gas, thus eliminating the need for a humidifier chamber or suitable downstream catheter associated with the delivery of humidified gas. Such a kit or package may include a patient interface, a filter, and a catheter (such a catheter may be a gas delivery catheter or a non-heated inhalation catheter) for delivering gas from a gas source to the patient interface.
[0049] The patient interface and filter may be provided separately in the package (i.e., not coupled or integrated). In some configurations, the patient interface and filter are coupled in the package, or the filter is integrated into the patient interface gas tube of the patient interface.
[0050] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for assembling a breathing circuit is disclosed. The method includes: providing a device, kit, or package as outlined in the foregoing aspects; positioning the inspiratory conduit downstream of the humidifier cavity; and positioning the filter and the patient interface downstream of the inspiratory conduit.
[0051] The method may further include receiving gas from the gas source at the humidifier, humidifying the gas, receiving the humidified gas from the humidifier at the filter, and delivering the humidified gas from the filter to the patient interface.
[0052] The method may further include positioning the gas delivery conduit upstream of the humidifier cavity and downstream of the gas source before receiving gas from the gas source at the humidifier.
[0053] The method may further include coupling the filter to the patient interface before delivering the humidified gas from the filter to the patient interface.
[0054] In some applications, the method further includes disconnecting the filter from the humidifier. In some applications, the method further includes operatively connecting the filter to another gas source.
[0055] After disconnecting the filter from the humidifier, the method may further include: providing an additional device or kit including a patient interface and a filter, the patient interface being used to deliver humidified gas to a patient, the filter being pneumatically connected to or configured to be placed in pneumatic communication with the patient interface; and positioning the filter and patient interface of the additional device downstream of the humidifier.
[0056] The method may further include receiving humidified gas from the humidifier at the filter and delivering the humidified gas from the filter to the patient interface.
[0057] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for delivering gas to a user or patient is disclosed. The method includes: providing a breathing circuit including a gas source and a device or kit or package as described above; and configuring the breathing circuit such that a humidifier receives gas from the gas source, an inhalation conduit is positioned downstream of the humidifier and delivers humidified gas from the humidifier to a filter, and a patient interface is positioned downstream of the filter and receives humidified gas from the filter and delivers the humidified gas to the user or patient.
[0058] The method may further include positioning the gas conduit downstream of the gas source to deliver gas from the gas source to the humidifier to humidify the gas.
[0059] In some applications, the patient is not breathing spontaneously and has already been anesthetized. In other applications, the patient is pre-oxygenated before being anesthetized.
[0060] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a device or kit is disclosed for use in a respiratory support system for delivering humidified gas to a user or patient. The device or kit includes:
[0061] A filter, the filter being positioned downstream of a humidifier to receive humidified gas from the humidifier, or configured to be positioned downstream of a humidifier to receive humidified gas from the humidifier; and
[0062] A patient interface for delivering humidified gas to a user or patient, wherein the patient interface is pneumatically connected to the filter downstream of the filter, or configured to be placed in pneumatic communication with the filter downstream of the filter.
[0063] The filter includes a gas inlet, a gas outlet, or both the gas inlet and the gas outlet, which includes a connection feature that enables the filter to be connected in an arrangement in which the filter is pneumatically connected to and disconnected from the patient interface.
[0064] The filter can be connected to the patient interface, or can be configured to be connected to the patient interface.
[0065] The patient interface may include a patient interface gas tube, wherein the filter includes a gas inlet port and a gas outlet port, and wherein the gas outlet port of the filter and the patient interface gas tube include complementary connection features to enable the filter to be coupled to the patient interface to provide pneumatic communication between the filter and the patient interface gas tube, wherein the filter is connected in series with a gas flow path through the patient interface gas tube.
[0066] The complementary connection features can be disconnected from each other, allowing the filter to be disconnected from the patient interface gas tube of the patient interface.
[0067] The patient interface may include a patient interface gas tube, wherein the filter is integrated into the patient interface gas tube to provide pneumatic communication between the filter and the patient interface gas tube, wherein the filter is in series with a gas flow path through the patient interface gas tube. Optionally, in such an arrangement, the gas inlet to such an integrated filter may include a complementary coupling feature. This complementary coupling feature may be provided, for example, by an adapter insert attached to the gas inlet of such an integrated filter component.
[0068] The filter may be a high-efficiency particulate filter (HEPA).
[0069] The filter may include a filter housing containing filter material. The filter material may include pleated paper, nanofibers, sock bag filters, stacked disc filters, spiral filters, filter media blocks, or filter media discs, wherein the filter media discs have a filter media flow that freely flows in and out of the discs.
[0070] The patient interface may include a nasal cannula or nasal mask, wherein the nasal cannula or nasal mask includes at least one gas flow path that is pneumatically in communication with the filter, or configured to be placed to be pneumatically in communication with the filter when the filter is attached to the patient interface. The nasal cannula may include at least one nasal delivery element extending from a flow manifold and adapted for placement in one or more of a user's nostrils to deliver humidified gas to the user, whether in a sealed or unsealed manner.
[0071] The device or kit may be provided as a kit.
[0072] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, an apparatus or kit is provided for delivering humidified gas to a user or patient. In some applications, the patient is under anesthesia and / or has been anesthetized and is not breathing spontaneously. In some applications, the patient is pre-oxygenated before being anesthetized.
[0073] Additionally, a packaging component is disclosed based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein. The packaging component includes a sealed container or bag that houses the equipment or kit outlined in the foregoing aspects.
[0074] The patient interface and filter are provided separately in the package.
[0075] The patient interface and filter can be coupled in the package, or the filter can be integrated into the gas tube of the patient interface.
[0076] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for assembling a breathing circuit is disclosed. The method includes: providing a device or kit or package as described above; and positioning the filter and patient interface downstream of a humidifier.
[0077] The method may further include receiving humidified gas from the humidifier at the filter and delivering the humidified gas from the filter to the patient interface.
[0078] The method may further include coupling the filter to the patient interface before delivering the humidified gas from the filter to the patient interface.
[0079] The method may include disconnecting the filter from the humidifier. In some applications, the method also includes operatively connecting the filter to another gas source.
[0080] After disconnecting the filter from the humidifier, the method may include: providing further devices, kits, or packages as outlined above; and positioning the filter and patient interface of the additional device downstream of the humidifier.
[0081] The method may further include receiving humidified gas from the humidifier at the filter and delivering the humidified gas from the filter to the patient interface.
[0082] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for delivering gas to a user or patient is disclosed. The method includes: providing a breathing circuit including a gas source, a humidifier receiving gas from the gas source downstream, and a device, kit, or package as outlined in the foregoing; and configuring the breathing circuit such that a filter is positioned downstream of the humidifier and receives humidified gas from the humidifier, and a patient interface is positioned downstream of the filter and receives humidified gas from the filter and delivers the humidified gas to the user or patient.
[0083] In some applications, the patient is not breathing spontaneously and has already been anesthetized. In other applications, the patient is pre-oxygenated before being anesthetized.
[0084] Furthermore, a respiratory support system is disclosed based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein. The respiratory support system includes:
[0085] An inhalation conduit having an inlet port and an outlet port, the inlet port being configured to receive gas from a gas source; a filter having an inlet port and an outlet port, wherein the inlet port of the filter is coupled to the outlet port of the inhalation conduit, such that the filter is in pneumatic communication with the inhalation conduit; and a patient interface including a patient catheter and a nasal cannula or nasal mask for delivering gas to a patient, wherein the patient interface is in pneumatic communication with the outlet port of the filter to receive gas from the outlet port of the filter, or
[0086] A single inspiratory catheter having an inlet port and an outlet port, the single inspiratory catheter providing for delivering a gas flow to a patient interface, the inlet port being configured to receive a gas flow from a gas source; a common filter having an inlet port and an outlet port, wherein the inlet port of the common filter is coupled to the outlet port of the single inspiratory catheter such that the common filter is in pneumatic communication with the single inspiratory catheter, and wherein the common filter receives a gas flow from the single inspiratory catheter; and a patient interface including a patient catheter and a nasal cannula or nasal mask for delivering gas to be filtered by the common filter to a patient, wherein the patient interface is in pneumatic communication with the outlet port of the common filter to receive gas from the outlet port of the common filter.
[0087] The filter can be connected in series between the outlet port of the inspiratory catheter and the patient catheter, or the common filter can be connected in series between the outlet port of the single inspiratory catheter and the patient catheter.
[0088] This specification may provide or reference to an inspiratory conduit, which may be a single inspiratory conduit. This inspiratory conduit provides an interface for delivering a flow of gas to the patient.
[0089] In this specification, where a filter is provided or referenced, such filter may be a common filter for filtering the gas flow supplied from the inspiratory conduit. This common filter receives the gas flow from the inspiratory conduit (e.g., a single inspiratory conduit). Therefore, gas delivered to the patient interface is provided from said common filter.
[0090] The patient catheter may include a patient interface gas catheter, wherein the filter (e.g., a common filter) is connected in series with the patient interface gas catheter.
[0091] The inlet port of the inhalation duct (e.g., a single inhalation duct) can be configured to receive humidified gas from the humidifier.
[0092] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a kit for use in a respiratory support system for delivering humidified gas to a user or patient is disclosed. The kit includes:
[0093] Humidifier chamber, the humidifier chamber being configured to be placed in pneumatic communication with a gas source;
[0094] An air intake duct, which is pneumatically connected to the humidifier cavity downstream of the humidifier cavity, or is configured to be placed in pneumatic communication with the humidifier cavity downstream of the humidifier cavity;
[0095] A filter, either pneumatically connected to or configured to be placed downstream of the inhalation conduit in pneumatic communication with it; and
[0096] A patient interface for delivering humidified gas to a user or patient, wherein the patient interface is pneumatically connected to the filter downstream of the filter, or is configured to be placed in pneumatic communication with the filter downstream of the filter.
[0097] The filter can be integrated into the patient interface. Optionally, in this embodiment, an adapter insert can be disposed on the gas inlet of the filter; such an adapter insert can be, for example, the type described elsewhere in this specification.
[0098] The kit may also include a gas delivery conduit configured to be placed in pneumatic communication with the gas source, wherein the humidifier chamber is pneumatically connected to the gas delivery conduit downstream of the gas delivery conduit, or is configured to be placed in pneumatic communication with the gas delivery conduit downstream of the gas delivery conduit.
[0099] At least some of the components in the kit can be provided separately in the kit.
[0100] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a kit for use in a respiratory support system for delivering humidified gas to a user or patient is disclosed. The kit includes:
[0101] A filter, configured to be positioned downstream of a humidifier to receive humidified gas from the humidifier; and
[0102] A patient interface for delivering humidified gas to a patient, wherein the patient interface is pneumatically connected to the filter downstream of the filter, or is configured to be placed in pneumatic communication with the filter downstream of the filter.
[0103] The filter can be integrated into the patient interface.
[0104] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a device or kit for use in a respiratory support system for delivering humidified gas to a user or patient is disclosed, the device or kit comprising:
[0105] A gas delivery conduit, which is pneumatically connected to a gas source or configured to be placed in pneumatic connection to the gas source;
[0106] A humidifier chamber, which is pneumatically connected to the gas delivery conduit downstream of the gas delivery conduit, or is configured to be placed in pneumatic communication with the gas delivery conduit downstream of the gas delivery conduit; and
[0107] An air intake conduit, which is pneumatically connected to the humidifier cavity downstream of the humidifier cavity, or is configured to be placed in a position to be pneumatically connected to the humidifier cavity downstream of the humidifier cavity.
[0108] Additionally, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a kit for use in a respiratory support system for delivering humidified gas to a user or patient is disclosed, the kit comprising:
[0109] It is configured to be placed into a gas delivery conduit that is pneumatically connected to a gas source;
[0110] A humidifier chamber, which is pneumatically connected to the gas delivery conduit downstream of the gas delivery conduit, or is configured to be placed in pneumatic communication with the gas delivery conduit downstream of the gas delivery conduit; and
[0111] An air intake conduit, which is pneumatically connected to the humidifier cavity downstream of the humidifier cavity, or is configured to be placed in a position to be pneumatically connected to the humidifier cavity downstream of the humidifier cavity.
[0112] The device or kit, package, respiratory support system, or kit may be configured for use in anesthesia procedures or procedures in which the patient’s respiratory power is impaired or reduced.
[0113] Each device or kit can be supplied individually or together. Different types of kits can be supplied together or individually. For example, a single package can contain two or more kits of the same or different types.
[0114] In addition, certain features, aspects, and advantages of the filters are provided independently or in accordance with at least one embodiment of the embodiments disclosed herein.
[0115] The filter arrangement may include a filter housing comprising a gas inlet port and a gas outlet port, wherein at least one (or both) of the inlet port and / or the outlet port is adapted to connect to another component (e.g., a connector located at the end of a conduit) via one or more (preferably at least one pair) male connecting fingers extending outward therefrom. Optionally, such male connecting fingers may provide complementary connection portions.
[0116] The male connector can be configured to extend from the gas outlet port. Alternatively, or alternatively, the male connector can be configured to extend from the gas inlet port.
[0117] One or each of the gas inlet port or gas outlet port may include an adapter insert configured to facilitate the connection with the other component.
[0118] The adapter insert may include the male connecting finger extending from a first end of the adapter insert.
[0119] The adapter insert may include one or more retaining members, each of which is substantially engageable with an inner surface portion of the filter housing.
[0120] Each retaining member can be configured to engage with the inner surface of the filter housing to retain the adapter insert within the port where the adapter is inserted.
[0121] Each of the retaining members can be configured to resist axial displacement of the adapter in the direction toward the outer end of the port.
[0122] Each of the retaining members may include at least a hook or other surface protrusion (e.g., a radially outwardly extending lug) to engage or lock with the inner surface of the filter housing.
[0123] This or each retaining member can hold the adapter insert within the port of the filter housing.
[0124] There can be four retaining members, or there can be two retaining members, or there can be multiple retaining members.
[0125] When more than one retaining member is provided, the retaining members can be arranged in an array that travels around the inner surface of the filter housing.
[0126] The adapter insert may include a first end, a second end, and a handle connecting the first end and the second end, wherein the male connector extends from the first end and the one or more retaining members extend from the second end.
[0127] The handle may include a cavity or gas flow path for gas to flow between the first end and the second end respectively.
[0128] The handle can be substantially accommodated within the port into which the adapter insert will be inserted.
[0129] The adapter insert may include one or more sealing members.
[0130] The adapter insert may include two or more sealing members.
[0131] The adapter insert may include two sealing members.
[0132] The adapter insert may include at least a first sealing member disposed around the handle portion and at least a second sealing member, the second sealing member being substantially disposed at or adjacent to the first end portion of the adapter insert.
[0133] At least one first sealing member may be provided around the handle.
[0134] The first sealing member or the first sealing member may be arranged around the circumference of the handle.
[0135] This or each of the first sealing members can be configured to provide a first sealing surface extending radially outward from the handle.
[0136] This or each of the first sealing members can be configured to provide a first sealing surface for sealing with the inner surface of the port of the filter housing.
[0137] This or each of the first sealing members may be located between the first end and the second end of the adapter insert.
[0138] At least one second sealing member may be disposed substantially at or adjacent to the first end of the adapter insert.
[0139] When the male connector extends from the first end of the adapter insert, the at least one second sealing member may be substantially at or adjacent to the base of the male connector.
[0140] The first end of the adapter insert may include a radially extending lug or lip.
[0141] The at least one second sealing member may be substantially located on the upper surface of the lug or lip.
[0142] The lug or lip may extend radially outward, such that its outer diameter is equal to or less than the outer diameter of the port in which the adapter insert will be located. Advantageously, the outer diameter of the lug or lip may be greater than the inner diameter of the port in which the adapter insert will be located.
[0143] The lower surface of the lug or lip can contact the terminal face of the port where the adapter insert will be located.
[0144] The distance between the lower surface of the lug or lip and the retaining member can match or can be substantially equal to the distance between the port in which the adapter insert will be positioned and the length of the adapter insert.
[0145] The lug or lip can be inserted into or clamped between the end of the handle and the first end of the adapter insert.
[0146] The lug or lip can be sandwiched between the base of the male connecting finger and the end of the handle.
[0147] The at least one second sealing member can be sandwiched between the base of the male connecting finger and the end of the handle.
[0148] The at least one second sealing member can be sandwiched between the base of the male connecting finger and the upper surface of the lug or lip.
[0149] The at least one second sealing member can provide a surface seal for the second sealing surface to abut against another component (e.g., another connector). Optionally, the other component (e.g., another connector) can be connected or engaged with the male connector, and in use, when such connection or engagement is made, the other component can additionally engage the second sealing member, and the second sealing member can be configured to operatively assist the pneumatic connection between the adapter insert and the other component.
[0150] Either or both of the first sealing member and the second sealing member may be an O-ring.
[0151] One or more splines or ribs may be positioned around the shank.
[0152] The one or more splines or ribs may extend longitudinally along the shank.
[0153] The one or more splines or ribs may extend radially outward from the shank to at least partially engage or make surface contact with the inner surface of the port in which the adapter insert will be positioned.
[0154] One or each of the one or more splines or ribs may be configured to provide reinforcement or structural support for the wall of the port in which the adapter insert will be positioned.
[0155] In addition to the one or more first sealing members, the adapter insert may have a maximum radial outer diameter equal to or less than 22 mm.
[0156] The lumen or gas flow path can transition from a generally wider orifice (or larger inner diameter) at the second end of the adapter insert to a generally narrower orifice (or smaller inner diameter) at the first end of the adapter insert.
[0157] The transition of the lumen or gas flow path can be a substantially gradual or substantially linear change between different apertures or inner diameters between the ends of the first end and the second end.
[0158] The adapter insert may be a modifiable component, a component that can be positioned with the component, or an insertable component, so as to configure the male connector as a connection system or connector for the component in which the adapter is inserted or positioned.
[0159] Additionally, adapter inserts are disclosed independently or in at least one of the other embodiments disclosed herein.
[0160] The adapter insert includes one or more (but may be at least a pair) male connecting fingers configured for connection or engagement with another connector, and one or more retaining members, each of which is substantially engageable with an inner surface portion of the body of the component in which the adapter insert will be positioned.
[0161] The adapter insert can be configured to be located in the gas inlet or gas outlet port of a component, for example, at the end of a conduit or at the inlet or outlet port of another component (e.g., but not limited to: a humidifier or a flow source generator).
[0162] As described in this specification, off-the-shelf filters can be adapted by inserting an adapter insert. The retaining member of the adapter insert helps to hold the adapter insert in the intended insertion position relative to the port of such filter (whether as an inlet or outlet port).
[0163] In the case of a component having a gas inlet port or a gas outlet port, such a port may include an adapter insert configured to facilitate engagement or connection with another component (e.g., a filter).
[0164] Optionally, the filter or filter arrangement includes a filter housing with a gas inlet port and a gas outlet port, wherein at least one (or both) of the inlet port and / or the outlet port is adapted to connect via the male connector of the adapter to another component (e.g., a connector located at the end of a conduit) when the adapter insert is located within the port.
[0165] The male connector of the adapter insert can be configured to extend from the gas outlet port or gas inlet port of the component (extending outward from there).
[0166] The male connector can extend from the first end of the adapter insert.
[0167] Each of the retaining members can be configured to engage substantially with the inner surface portion of the component in which the adapter insert will be positioned.
[0168] Each retaining member can be configured to engage with the inner surface of the component to retain the adapter insert within the port into which the adapter insert will be inserted.
[0169] Each of the retaining members can resist axial displacement of the adapter insert in the direction toward the outer end of the port of the component (e.g., the retaining members help resist accidental disconnection of the adapter insert from the component into which it is inserted, or positioned, or has been inserted, or has been positioned).
[0170] Each of the retaining members can be configured to position the adapter insert internally in an internal anchoring position within the component.
[0171] Each of the retaining members may include at least a hook or other surface protrusion (e.g., a radially outwardly extending lug) to engage or lock with the inner surface of the component.
[0172] This or each retaining member can hold the adapter insert within the port of the component.
[0173] There can be four retaining members, or there can be two retaining members, or there can be one retaining member, or there can be multiple retaining members.
[0174] When more than one retaining member is provided, at least some of the retaining members can be arranged to form an array around the inner surface of the component.
[0175] The adapter insert may include a first end, a second end, and a handle connecting the first end and the second end, wherein the male connector extends from the first end and the one or more retaining members extend from the second end.
[0176] The handle may include a cavity or gas flow path for gas to flow between the first end and the second end respectively.
[0177] The handle can be substantially accommodated within the port of the component into which the adapter insert will be inserted.
[0178] The adapter insert may include one or more sealing members.
[0179] The adapter insert may include two or more sealing members.
[0180] The adapter insert may include two sealing members.
[0181] The adapter insert may include at least a first sealing member disposed around the handle portion and at least a second sealing member, the second sealing member being substantially disposed at or adjacent to the first end portion of the adapter insert.
[0182] At least one first sealing member may be provided around the handle.
[0183] The first sealing member or the first sealing member may be arranged around the circumference of the handle.
[0184] This or each of the first sealing members can be configured to provide a first sealing surface extending radially outward from the handle.
[0185] This or each of the first sealing members can be configured to provide a first sealing surface for sealing with the inner surface of the port of the component.
[0186] This or each of the first sealing members may be located between the first end and the second end of the adapter insert.
[0187] At least one second sealing member may be disposed substantially at or adjacent to the first end of the adapter insert.
[0188] When the male connector extends from the first end of the adapter insert, the at least one second sealing member may be substantially at or adjacent to the base of the male connector.
[0189] The first end of the adapter insert may include a radially extending lug or lip.
[0190] The at least one second sealing member may be substantially located on the upper surface of the lug or lip.
[0191] The lug or lip may extend radially outward, such that its outer diameter is equal to or less than the outer diameter of the port of the component in which the adapter insert will be located. Advantageously, the outer diameter of the lug or lip may be greater than the inner diameter of the port of the component in which the adapter insert will be located.
[0192] The lower surface of the lug or lip can contact the terminal face of the port of the component in which the adapter insert will be located.
[0193] The distance between the lower surface of the lug or lip and the retaining member can match or be substantially equal to the distance from the port of the component in which the adapter insert will be positioned to the length of the adapter insert.
[0194] The lug or lip can be inserted or clamped between the end of the handle and the first end of the adapter insert.
[0195] The lug or lip can be sandwiched between the base of the male connecting finger and the end of the handle.
[0196] The at least one second sealing member can be sandwiched between the base of the male connecting finger and the end of the handle.
[0197] The at least one second sealing member can be sandwiched between the base of the male connecting finger and the upper surface of the lug or lip.
[0198] The at least one second sealing member can provide a surface seal for the second sealing surface to abut against another component (e.g., another connector). Optionally, the other component (e.g., another connector) can be connected or engaged with the male connector, and in use, when such connection or engagement is made, the other component can additionally engage the second sealing member, and the second sealing member can be configured to operatively assist the pneumatic connection between the adapter insert and the other component.
[0199] Either or both of the first sealing member and the second sealing member may be an O-ring.
[0200] One or more splines or ribs may be positioned around the shank.
[0201] The one or more splines or ribs may extend longitudinally along the shank.
[0202] The one or more splines or ribs may extend radially outward from the shank to at least partially engage or make surface contact with the inner surface of the port of the component in which the adapter insert will be positioned.
[0203] One or each of the one or more splines or ribs may be configured to provide reinforcement or structural support to the wall of the port of the component in which the adapter insert will be positioned.
[0204] In addition to the one or more first sealing members, the adapter insert may have a maximum radial outer diameter equal to or less than 22 mm.
[0205] The lumen or gas flow path can transition from a generally wider orifice (or larger inner diameter) at the second end of the adapter insert to a generally narrower orifice (or smaller inner diameter) at the first end of the adapter insert.
[0206] The transition of the lumen or gas flow path can be a substantially gradual or substantially linear change between different apertures or inner diameters between the ends of the first end and the second end.
[0207] The components described above can be filters, such as the filters defined above.
[0208] Another component may be a connector provided as part of a medical breathing circuit or another section of a breathing system.
[0209] According to any one or more embodiments described herein, the following additional features may be provided:
[0210] For example, when referring to the patient interface, this interface could be a nasal cannula or a nasal mask.
[0211] For example, the device described herein may be provided as part of a system that includes a gas supply that can be coupled to the device to supply gas to a patient interface or other components associated with a breathing circuit or respiratory therapy system.
[0212] The gas supply can be configured to supply gas to the humidifier at a flow rate between about 5 liters per minute (LPM) and about 120 LPM, or at a flow rate up to about 150 LPM, or at a flow rate between about 50 LPM and about 80 LPM, or at a flow rate of about 70 LPM. In some configurations, the humidifier can be configured to supply gas to the patient interface at a humidity of about 44 mg / L.
[0213] The humidifier can be configured to supply gas to the patient interface at a temperature of approximately 37°C.
[0214] According to the various configurations or embodiments disclosed in this specification, the patient interface may be a nasal cannula or nasal mask interface, which includes a gas delivery component in the form of a manifold detachably attached to the body of the nasal cannula or nasal mask.
[0215] The detachably attached manifold allows for left-right reversibility of the gas delivery catheter supplying gas to the patient interface. The manifold may be a push-fit arrangement or may be attached to the body but detachable to allow rotation or swivel of the manifold relative to the body for reorientation of the manifold and associated gas supply catheter.
[0216] The patient interface used according to the different embodiments described in this disclosure may be a type of headgear that includes at least one strap, such as a strap that includes a bifurcated segment or region (i.e., a weak line or other predetermined region that can be separated by the user).
[0217] The tubing described herein (which may also be referred to herein as catheter, conduit, or conduit circuit) is preferably made of medical tubing or medical-grade tubing suitable for use in medical procedures and / or as part of a breathing circuit or respiratory therapy circuit.
[0218] The adapter insert described herein can be used in conjunction with filters (e.g., gas inlets or outlets of filters) described elsewhere in this specification, or for fitting to the end of a conduit, for example, with a connector located at such a conduit end. The adapter insert facilitates connection to other components that do not have suitably configured connectors other than the adapter insert. Therefore, the insert not only allows for the fitting of components to be attached but also provides an adapter connector that can be connected to other components.
[0219] Because of the relatively high gas delivery flow rate that can be used with the embodiments or configurations described herein, the gas supplied to or delivered to a user or patient can be delivered to different parts of the user's or patient's airway. The supplied gas can reach the patient's lungs or any part of the respiratory system.
[0220] For example, according to the different embodiments and configurations described herein, the flow rate of gas supplied or provided to the interface or via the system (such as through a flow path) may include, but is not limited to, a flow rate of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, or 150 liters per minute (LPM) or more, and the available range may be selected between any of these values (e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 80 LPM). Optionally, the supplied gas may be delivered in a fully saturated or humidified state, or saturated or humidified gas may be mixed with other gases to supply or deliver to the patient interface or the patient.
[0221] Such relatively high gas flow rates can help deliver the supplied gas into the user's airway or to different parts of the user's airway. For example, such flow rates can allow the gas to be delivered to the upper or lower airway regions. The upper airway regions typically include the nasal cavity, pharynx, and larynx, while the lower airway regions typically include the trachea, main bronchi, and lungs.
[0222] It is desirable to provide a system and piping for such a system, wherein the humidity and temperature of the gas in the system reach ideal gas conditions as quickly as possible, such as about 37°C and about 44 mg / L.
[0223] According to at least one embodiment disclosed herein, a connector is provided for connecting a breathing circuit to a patient interface including a filter.
[0224] The connector may include a one-way valve.
[0225] According to at least one other embodiment disclosed herein, a connector is provided for connecting a breathing circuit to a patient interface, the patient interface including a filter pneumatically connected to a one-way valve.
[0226] In the connector, the filter is a HEPA filter, a sock bag filter, a disc filter, a spiral filter, a pleated plate filter, a filter media block, a nanofiber filter, or a filter media disc, wherein the filter media disc has a filter media flow that flows freely from the disc into and out of the disc.
[0227] In the connector, the one-way valve can open in response to the application of flow applied through the breathing circuit or toward the patient interface, and can close or shut in response to the absence of flow applied through the breathing circuit or toward the patient interface.
[0228] In the connection, the filter can be attached to the outlet of the one-way valve.
[0229] In the connector, the one-way valve may be a duckbill valve.
[0230] In the connection, the filter may include expandable filter media attached to the duckbill end of the duckbill valve such that when the valve is opened, the filter media expands to allow flow through the valve and the filter media.
[0231] The connector may be a shrink fitting, a sleeve, or an adapter.
[0232] In the connector, the filter is formed of a filter media comprising one or more of the following materials: mineral fibers, glass fibers, ceramic fibers, polypropylene, expanded polytetrafluoroethylene, modified polyacrylate, and Estane polyurethane elastic fibers. Cellulose fibers or electrostatic fibers.
[0233] The filter may be hydrophobic.
[0234] The filter can be for still water.
[0235] The filter allows air and water vapor to pass through.
[0236] The connector can be provided as a disposable item.
[0237] According to at least one embodiment disclosed herein, a breathing circuit including a filter is provided. Optionally, the conduit of the breathing circuit may include the filter. The filter may be located at or adjacent to an end of the conduit. The filter may include one or more features as described above with respect to a connector including a filter.
[0238] According to at least one embodiment disclosed herein, the filter for a breathing circuit and / or patient interface is one of the following: a HEPA filter, a sock-bag filter, a disc filter, a spiral filter, a pleated filter, a nanofiber filter, a filter media block, or a filter media disc having a filter media flow that freely flows in and out of the disc. The filter is adapted to be fitted into a patient interface or breathing circuit tubing.
[0239] According to the above embodiments, the filter can be formed from filter media comprising one or more of the following materials: mineral fibers, glass fibers, ceramic fibers, polypropylene, expanded polytetrafluoroethylene, modified polyacrylate, and Estane polyurethane elastic fibers. Cellulose fibers or electrostatic fibers.
[0240] The filter may be hydrophobic.
[0241] The filter can be for still water.
[0242] The filter allows air and water vapor to pass through.
[0243] The connector can be provided as a disposable item.
[0244] According to at least one embodiment disclosed herein, a patient interface tube is provided comprising an open-pore foam material having a sealing epidermis, such that the patient interface tube is breathable because it allows water vapor to pass through the material and the sealing epidermis, but does not allow liquid water or a large flow of gas to pass through therethrough, the interface tube providing a tube or conduit for providing a gas flow from a breathing circuit to the patient interface.
[0245] According to at least one embodiment disclosed herein, a nasal cannula is provided, the nasal cannula comprising one or two nose forks for wearing into a patient's nostrils, each nose fork providing a filter for gas flow from the patient interface to the patient.
[0246] According to at least one embodiment disclosed herein, a filter and valve arrangement for a breathing circuit is provided, the filter and valve arrangement including a one-way valve and a filter attached to the outlet of the one-way valve.
[0247] The one-way valve may be a duckbill valve.
[0248] The filter may include expandable filter media attached to the duckbill end of the duckbill valve, such that when the valve is opened, the filter media expands to allow flow through the valve and the filter media.
[0249] According to at least one embodiment disclosed herein, a method for preventing contamination of a breathing circuit used by more than one patient is provided, the method comprising installing a filter in the breathing circuit or patient interface to prevent contamination of the breathing circuit used by multiple patients.
[0250] According to at least one embodiment disclosed herein, a method for preventing contamination of a breathing circuit used by more than one patient is provided, the method comprising disinfecting the breathing tubing or tube of the breathing circuit with a disinfectant, wherein the disinfectant comprises one or more of phthalaldehyde, glutaraldehyde, hydrogen peroxide, and nitrogen dioxide (in liquid or gaseous form).
[0251] The disinfectant can be dispensed from the disinfectant reservoir into the breathing tube or tubing, and the disinfectant is released from the disinfectant reservoir when the circuit is not in use on the patient.
[0252] The method can also use a sterilization sac that covers the end of the breathing circuit.
[0253] The bladder may include a button for releasing disinfectant.
[0254] The bladder can be built into the breathing circuit or it can be a separate component that the user inserts into the end of the breathing circuit.
[0255] The disinfectant reservoir can be disposed in the wall of the connector of the breathing circuit or the conduit of the breathing circuit, and can be released into the breathing circuit via a release mechanism and a one-way valve.
[0256] The release mechanism can be actuated by a signal generated when the patient interface is removed from the circuit. For example, the signal can be an electrical signal, a mechanical signal, or a magnetic signal.
[0257] The rinsing and disinfection unit can be attached to each end of the breathing circuit and the circuit can be rinsed alternately with water or disinfectant.
[0258] According to at least one embodiment disclosed herein, a disinfectant sac for disinfecting a breathing circuit is provided, the disinfectant sac including a reservoir and a release mechanism for releasing disinfectant into the breathing circuit.
[0259] The sac can form a cap for covering the end of the breathing tube or conduit of the breathing duct.
[0260] The release mechanism may include a button for releasing disinfectant.
[0261] The bladder can be built into the breathing circuit or it can be a separate component that the user inserts into the end of the breathing circuit.
[0262] A signal can be generated when the patient interface is removed from the circuit to trigger the release of disinfectant. Such a signal can be an electrical, mechanical, or magnetic signal.
[0263] According to at least one embodiment disclosed herein, a breathing circuit is provided, the breathing circuit including a reservoir and one or more valves, the reservoir being in the wall of a tube or conduit of the breathing circuit for storing a certain amount of disinfectant, the one or more valves being between the reservoir and the lumen of the breathing circuit, wherein, in use, the disinfectant is released from the reservoir or can be released into the breathing circuit by actuation of the valves.
[0264] The breathing circuit may include a release mechanism for actuating the valve to release the disinfectant.
[0265] A signal can be generated when the patient interface is removed from the circuit to trigger the release of disinfectant. Such a signal can be an electrical, mechanical, or magnetic signal.
[0266] According to at least one embodiment disclosed herein, a method is provided for preventing contamination of a breathing circuit intended for use by more than one patient, the method comprising attaching a rinsing and disinfection unit to each end of the breathing circuit and using the unit to alternately rinse the circuit with water and disinfectant.
[0267] According to at least one embodiment disclosed herein, a method for preventing contamination of a breathing circuit used by more than one patient is provided, the method comprising providing radiation (e.g., ultraviolet light or near-infrared ultrashort pulse laser) to the breathing circuit to inactivate microorganisms.
[0268] The method may include emitting sheet radiation at the connection point between the breathing circuit and the patient interface.
[0269] The radiation can be continuously delivered to the breathing circuit, including during the patient's use of the circuit.
[0270] The radiation can only be delivered to the breathing circuit when the patient interface (from the breathing circuit) is disconnected.
[0271] According to at least one embodiment disclosed herein, a connector or conduit for a breathing circuit is provided, which includes a radiation source to prevent contamination of the breathing circuit for use by more than one patient.
[0272] The radiation source can provide sheet radiation at the connection point used to connect the patient interface to the breathing circuit.
[0273] The radiation source can provide individual beam radiation or sheet radiation throughout the circuit.
[0274] According to at least one embodiment disclosed herein, a humidifier or other hardware for a respiratory system upstream of a breathing circuit is provided, which is connected to an end of the breathing circuit including a radiation source that provides radiation to the breathing circuit to prevent contamination of the breathing circuit used by more than one patient.
[0275] According to at least one embodiment disclosed herein, a method for preventing contamination of a breathing circuit is provided, comprising increasing the heat in the breathing circuit to kill microorganisms during a period of time between patients (with or without gas flow).
[0276] The method may include increasing the heat output of the heating element in the breathing circuit during the time period.
[0277] The disinfection unit can be attached to each end of the breathing circuit and is used to circulate hot water and detergent (e.g., at 90°C) through the breathing circuit during the stated time period. The disinfection unit can be a separate unit or can be integrated with any other hardware (e.g., a humidifier) upstream of the breathing circuit.
[0278] A heating collar can be installed at the connection point between the breathing circuit and the patient interface to prevent infectious substances from migrating from the patient into the breathing circuit.
[0279] According to at least one embodiment disclosed herein, a breathing circuit is provided, comprising a tube or conduit or other component in contact with breathing gas, said tube or conduit or other component being formed of a plastic material having one or more antimicrobial additives.
[0280] The additives may be one or more of the following: silver and silver-based additives (colloidal silver, silver salts, silver zeolite, nano silver), siloxane additives, triclosan, and copper.
[0281] The breathing circuit may include a collar around the end or connection point of the breathing circuit that is attached or attachable to the patient interface, the collar being formed of the material and one or more antimicrobial additives.
[0282] The breathing circuit or the entire breathing circuit can be made with antimicrobial additives, for example, the breathing tube or catheter can be made of plastic material including antimicrobial additives.
[0283] According to at least one embodiment disclosed herein, a breathing circuit is provided, which includes a cap for covering the end of the breathing circuit to prevent contamination of the breathing circuit.
[0284] The sealing cap can be built into the breathing circuit and can be activated by a signal to cover the end of the breathing circuit. For example, the signal can be an electrical, mechanical, or magnetic signal generated when the patient interface is removed or pulled out of the breathing circuit.
[0285] The breathing circuit may include a pressure relief system or a choke system to prevent overpressure in the breathing circuit when the cap covers the end of the breathing circuit.
[0286] The cap may include a pressure relief mechanism.
[0287] The sealing cap may include a pressure reducing valve.
[0288] According to at least one embodiment disclosed herein, a breathing circuit is provided that includes an orifice to generate a rapid flow through the orifice to prevent infectious material from returning to the apex breathing circuit against the flow direction through the orifice.
[0289] The orifice can be configured to provide a Pecklet number greater than 1, or 10, or 1000.
[0290] According to at least one embodiment disclosed herein, a breathing circuit, or patient interface, or connector for connecting the breathing circuit to the patient interface is provided, which includes a one-way valve to prevent contaminants from the patient from entering the breathing circuit.
[0291] The valve may be one of a duckbill valve, umbrella valve, check ball valve, or constant speed valve.
[0292] The valve can be aspirated, such that gas flow passes through the valve only during the aspiration process when the pressure difference across the valve allows the valve to open.
[0293] The breathing circuit may include a pressure relief system to ensure that the breathing circuit is not overpressurized.
[0294] According to at least one embodiment disclosed herein, a method is provided for preventing contamination of a breathing circuit used by more than one patient, the method comprising providing a one-way valve to the breathing circuit or patient interface to prevent contaminants from the patient from entering the breathing circuit.
[0295] The valve may be one of a duckbill valve, umbrella valve, check ball valve, or constant speed valve.
[0296] The valve can be configured as a separate element to be inserted into or attached to a catheter and / or patient interface.
[0297] According to at least one embodiment disclosed herein, a method is provided for preventing contamination of a breathing circuit used by more than one patient, the method comprising: providing a breathing gas flow to a patient through the breathing circuit at a first flow rate during an operating mode; and providing a breathing gas flow through the breathing circuit at a second flow rate during a non-operating mode, wherein the first flow rate is higher than the second flow rate. Flow along the breathing circuit at the second flow rate is sufficient to prevent or reduce contamination entering the breathing circuit.
[0298] The first flow rate may be about 70 L / min, and the second flow rate may be about 10 L / min.
[0299] The flow source can provide a respiratory gas flow to the breathing circuit or other hardware of the breathing system upstream of the breathing circuit, the flow source including a switching switch that allows the flow to switch from a first flow rate in an operating mode to a second flow rate in a non-operating mode.
[0300] The upstream device (such as a flow source) of the breathing circuit may include an electrical connection that enables a second flow rate when the flow source is connected to the breathing circuit and / or when the patient interface is disconnected from the breathing circuit.
[0301] The equipment (such as a flow source) upstream of the breathing circuit may include an electrical connection that enables a second flow rate when the breathing circuit is connected to a patient interface.
[0302] Upstream equipment (such as a flow source) in the breathing circuit may include a mechanical switching switch (e.g., a push valve) that allows orifice openings of different sizes to be introduced into the flow path to switch between the first flow rate and the second flow rate.
[0303] According to at least one embodiment disclosed herein, a breathing circuit, or patient interface, or connector for connecting the breathing circuit to the patient interface is provided, comprising a screen made of a hydrophobic material at a connection point between the patient interface and the breathing circuit for breathing, the screen being adapted to prevent contaminants from the patient from entering the breathing circuit.
[0304] The breathing circuit may include a catheter, and the screen is disposed at the end of the catheter.
[0305] The patient interface may include an inlet for connection to the breathing circuit, and the screen is disposed in the inlet.
[0306] The screen may be hydrophobic.
[0307] The screen may have a certain pore size that allows flow through the screen at an operating flow rate and operating pressure at the patient interface, but does not allow (or prevent) exhaled breaths from the patient to pass through the screen, such that the pressure (or flow rate) of the exhaled breaths is too low for the exhaled breaths to pass through the screen.
[0308] The sieve may have a pore size that allows an operating flow rate of approximately 70 L / min to be delivered from the breathing circuit to the patient.
[0309] Because the relatively high gas delivery flow rate can be used with the embodiments or configurations described herein, the gas supplied or delivered to the patient can be delivered to different parts of the patient's airway.
[0310] Filters as described herein, or components associated with said filters, can be adapted by connecting adapter inserts, which may be as described elsewhere in this specification.
[0311] For example, depending on the different embodiments and configurations described herein, the flow rate of gas supplied or provided to an interface or via a system (e.g., through a breathing circuit) may include, but is not limited to, the flow rate defined by the high gas delivery flow rate described above.
[0312] This relatively high gas flow rate can help deliver the supplied gas into the patient's airway or to different parts of the airway. For example, such a flow rate can allow the gas to be delivered to the upper or lower airway regions. The upper airway regions typically include the nasal cavity, pharynx, and larynx, while the lower airway regions typically include the trachea, main bronchi, and lungs.
[0313] Certain features, aspects, and advantages of some configurations disclosed herein have been described with reference to respiratory circuits intended for use in parallel with or in conjunction with anesthesia respiratory circuits. However, certain features, aspects, and advantages of the described configurations can be advantageously used with other respiratory systems.
[0314] As used in this specification, the term "comprising" means "consisting of at least in part with...". When interpreting each statement in this specification containing the term "comprising," there may also be features other than the one or more features following that term. Related terms such as "comprise" and "comprises" will be interpreted in the same manner.
[0315] The invention may also be broadly represented as including, individually or collectively, any or all combinations of any two or more of the parts, elements or features mentioned or indicated in the application specification, and when a particular whole having a known equivalent in the field of the invention is referred to herein, such known equivalents are considered to be incorporated herein as if set forth separately.
[0316] This invention includes the foregoing, and also contemplates constructions described below as examples only. Attached Figure Description
[0317] Referring to the following figures, specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein, in which:
[0318] Figure 1 A typical human airway is shown, and arrows are included to indicate how to effectively propel or drive the supplied gas further or deeper into the user's airway when the human body is not in a normal or typical spontaneous breathing state, or when the patient is experiencing respiratory arrest, using a relatively high flow rate of gas supplied to the user.
[0319] Figure 2 It schematically illustrates the combination of Figure 3 or Figure 4 The kit is a respiratory therapy system in which patient P wears a patient interface.
[0320] Figure 3 Components of a first configuration kit or device for use in the respiratory therapy system are shown.
[0321] Figure 4 Components for a second configuration kit or device used in the respiratory therapy system are shown.
[0322] Figure 5 A side view of a cross section of an exemplary filter used in the kit or device is shown.
[0323] Figures 6A-6D It shows Figure 5 The assembly process of the filter.
[0324] Figure 6E Is it through Figure 6F A cross-sectional view. Figure 6F An arrangement is shown in which the filter housing has an adapter insert located within a port, and another component is connected to the adapter insert.
[0325] Figure 6G It is a side view of the adapter insert including the sealing member.
[0326] Figure 6HIt was rotated 90° Figure 6G Adapter inserts.
[0327] Figure 6I yes Figure 6G A cross-sectional view of the adapter insert.
[0328] Figure 6J This is a side view of the adapter insert excluding the sealing component.
[0329] Figure 6K yes Figure 6J A cross-sectional view of the adapter insert.
[0330] Figure 6L and Figure 6M These are different end perspective views of the adapter insert.
[0331] Figure 6N yes Figure 6E and Figure 6F An exploded perspective view of the parts shown that fit together or join (or connect to each other).
[0332] Figure 7 This is a perspective view of a first exemplary form of nasal cannula assembly for use in the kit or device.
[0333] Figure 8 yes Figure 7 An exploded perspective view of the first form of the nasal cannula assembly shows the two parts that make up the nasal cannula: a face mounting portion and a gas flow manifold portion attached to a conduit for supplying gas to the patient.
[0334] Figure 9 This is a perspective view of a second exemplary form of nasal cannula assembly for use in the kit or device, showing conduits that supply gas to the gas flow manifold portion and the facial mounting portion when connected.
[0335] Figure 10 yes Figure 9 A perspective view of a second form of nasal cannula assembly, wherein the gas flow manifold portion is disengaged from the facial mounting portion.
[0336] Figure 11 yes Figure 9 A perspective view of a second form of nasal cannula assembly, wherein the gas flow manifold portion is disengaged from the face mount portion, showing that the manifold portion can be fitted onto either side of the face mount portion.
[0337] Figure 12 yes Figure 9 A rear perspective view of the second form of the nasal cannula shows a removable breathable pad on the inside of the face mounting portion, which rests against the patient's face.
[0338] Figure 13 This is a perspective view of a third exemplary form of nasal cannula assembly for use in the kit and device, with particular emphasis on a gas flow manifold portion that allows attachment of a removable fork.
[0339] Figure 14 This is a perspective view of the third form of nasal cannula assembly, showing its assembly into... Figure 13 The straps and breathable pads on the manifold section.
[0340] Figure 15 It is able to attach to Figure 13 A perspective view of the first form of removable fork on the manifold section.
[0341] Figure 16 It is able to attach to Figure 13 A perspective view of the second form of removable fork on the manifold section.
[0342] Figure 17 Is wearing Figure 9 A perspective view of a patient with a nasal cannula assembly, showing the use of a neck strap to support some of the weight of the cannula and a head strap to help hold the assembly in the patient's face.
[0343] Figure 18 This is a front view of a patient wearing a nasal cannula assembly, which is held in place on the patient's face with the help of an ear loop.
[0344] Figure 19 yes Figure 18 Side view of the patient and nasal cannula assembly.
[0345] Figure 20 This is a perspective view of an exemplary tracheostomy fitting that can be used in place of the nasal intubation assembly in the kit and device.
[0346] Figure 21 This is the patient's front view, in which, Figure 20 The tracheostomy fittings are attached to the respiratory supply, with a neck strap or lanyard used to support the tube supplying gas to the patient.
[0347] Figure 22A It is a schematic diagram of a connector or component that includes a filter element.
[0348] Figure 22B It is a schematic diagram of a connector or component that includes an alternative filter element.
[0349] Figure 22C It is a schematic diagram of a connector or component that includes another alternative filter element.
[0350] Figure 22DIt is a schematic diagram of a connector or component that includes another alternative filter element.
[0351] Figure 22E This is a schematic diagram of another alternative filter element.
[0352] Figure 23A and Figure 23B It is a schematic diagram of a connector or component including a one-way valve and a filter element integrated with the one-way valve. Figure 23A A one-way valve in a closed configuration is shown, and Figure 23B A one-way valve in the open configuration is shown.
[0353] Figure 24A A sterilization sac or reservoir adapted for insertion into a breathing tube is shown.
[0354] Figure 24B It is assembled into the end of the catheter. Figure 24A A schematic diagram of the cross-section of the disinfection sac is shown.
[0355] Figure 25A A schematic diagram showing the end of the breathing circuit catheter and the radiation sheet delivered at the end of the catheter to prevent contamination.
[0356] Figure 26A and Figure 26B A cap provided to a breathing circuit is shown to prevent contamination from entering the breathing circuit.
[0357] Figure 27A A one-way valve is shown as part of a breathing circuit or patient interface, and the valve is shown in both the closed and open positions.
[0358] Figure 27B An alternative one-way valve is shown as a part of a breathing circuit or patient interface, and the valve is shown in both the closed and open positions.
[0359] Figure 27C An alternative one-way valve is shown as a part of a breathing circuit or patient interface, and the valve is shown in both the closed and open positions. Detailed Implementation
[0360] Figure 1A typical human airway is illustrated, and arrows are included to indicate how a relatively high flow rate of gas supplied to the user can be used to effectively propel or drive the supplied gas further or deeper into the user's airway when the person is not in a normal or typical spontaneous breathing state. Using high-flow-rate gas delivery helps to push the gas flow and therefore O2 deeper into the patient's airway. In certain situations, high-flow-rate gas delivery can be utilized when the patient is not breathing spontaneously (i.e., when the patient is experiencing respiratory arrest).
[0361] The device described herein can be used in respiratory care or treatment systems, whether for high-flow or low-flow therapy, or as a sealed or unsealed interface, such as a humidified PAP delivery system or an inpatient respiratory care system.
[0362] Figure 2 A humidified breathing circuit is illustrated. Patient P receives humidified and pressurized gas via a nasal cannula assembly of patient interface 601, which is operatively connected via filter 501 to the delivery path of the humidified gas or inhalation conduit 401. Inhalation conduit 401 is then connected to a humidifier 200 (including a humidifier chamber 251), to which gas is supplied from a blower 15 or other suitable gas supply device via gas delivery conduit 301. The gas delivery conduit is a 'dry' conduit, meaning it is positioned upstream of the humidifier. A headgear 620 is provided to support the patient's face and hold the patient interface.
[0363] An intake conduit 401 is connected to an outlet 257 of a humidifier chamber 251, which contains a volume of liquid, such as water. The humidifier chamber 251 may be formed of a plastic material and may have a highly thermally conductive base 259 (e.g., an aluminum base) that is in direct contact with the heater plate 203 of the humidifier 200.
[0364] The humidifier 200 is equipped with a control device or electronic controller 205, which may include a microprocessor-based controller that executes computer software commands stored in associated memory. Gas flowing through the inhalation duct 401 is delivered to the patient via a filter 501 and a patient interface 601.
[0365] The controller 205 receives input from a source such as a user input device or dial 207, through which the user of the device can, for example, set a predetermined desired value (preset value) for the humidity or temperature of the gas supplied to the patient P. In response to the user-set humidity or temperature value input via dial 207 and other possible inputs (e.g., internal sensors sensing gas flow or temperature), or parameters calculated in the controller, the controller 205 determines when (or to what level) to energize the heater plate 203 to heat the water in the humidifier chamber 251. When a certain volume of water in the humidifier chamber 251 is heated, water vapor begins to fill the volume of the chamber above the water surface and is conveyed out of the outlet port 257 of the humidifier chamber 251 with a gas flow (e.g., air) provided by a gas supply device or blower 15 that enters the chamber through the gas inlet port 255. It should be noted that the relationship between the humidity of the gas in the humidifier chamber 251 and the temperature of the heater plate 203 can be obtained. Therefore, the humidity of the gas can be determined using the heater plate temperature in an algorithm or lookup table.
[0366] Blower 15 may be equipped with a variable-speed pump or fan 2 that draws in air or other gases through blower inlet 17. The speed of the variable-speed pump or fan 2 may be controlled by another controller or electronic controller 18 in response to inputs from controller 205 and a predetermined desired value (preset value) of pressure, fan speed, or flow rate set by the user via dial 19 or other input device (or alternatively, the function of this controller 18 may be performed by another controller 205). Alternatively, gas may be supplied from a wall supply (i.e., the wall gas port GP in wall W).
[0367] The blower housing 16 is equipped with an outlet port 20. The inlet port 303 of the gas delivery duct 301 and the outlet port 20 of the blower are equipped with complementary coupling features to connect the outlet port 20 to the inlet port 303 and provide a gas flow path through them. These complementary coupling features may be provided in part by an adapter insert providing a male connector, such as an adapter insert 900. In this way, different ports of articles or components to which the adapter insert can be attached or connected can be considered as 'another component' to which the adapter insert can be attached or connected, as further described in this specification.
[0368] The yang connection refers to the first part that can provide a complementary connection.
[0369] In some configurations, instead of using a blower 15, the gas flow can be obtained from other gas sources. For example, in some configurations, the gas source may include one or more containers of compressed air and / or another gas, and one or more valve arrangements adapted to control the rate at which the gas exits the one or more containers. As another example, in some configurations, the gas may be obtained from an oxygen concentrator. The system may also include a supplemental gas source to provide a mixture of air and supplemental gas. For example, the supplemental gas may be O2. In some configurations, the device may be adapted for delivering high-flow-rate therapy.
[0370] As used in this disclosure, “high-flow therapy” may refer to the delivery of gas to a patient at a flow rate greater than or equal to about 5 or 10 liters per minute (5 or 10 LPM).
[0371] In some configurations, "high-flow-rate therapy" can refer to the delivery of gas to a patient at a flow rate between about 5 or 10 LPM and about 150 LPM, or about 15 LPM and about 95 LPM, or about 20 LPM and about 90 LPM, or about 25 LPM and about 85 LPM, or about 30 LPM and about 80 LPM, or about 35 LPM and about 75 LPM, or about 40 LPM and about 70 LPM, or about 45 LPM and about 65 LPM, or about 50 LPM and about 60 LPM. For example, according to these different embodiments and configurations described herein, the flow rate of gas supplied or provided to an interface or via a system (e.g., through a flow path) may include, but is not limited to, at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 L / min or more, and useful ranges may be selected from any of these values (e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L / min, about 70 to 80 L / min).
[0372] The delivered gas may contain a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%.
[0373] High-flow therapy has been found to be effective in meeting or exceeding a patient's normal actual inspiratory needs, thereby increasing oxygenation and / or reducing the work of breathing. Additionally, high-flow therapy can generate effective flushing in the nasopharynx, thus clearing anatomically dead spaces in the upper airway with a high inlet gas flow. This creates a reserve of fresh gas available with each breath while minimizing the re-inhalation of carbon dioxide, nitrogen, etc.
[0374] The humidifier 200 has a humidifier base that includes a housing 201 with a heater 203, a controller 205 coupled to the heater, and a user input device 207 that allows a user to turn the humidifier on and off and select the desired temperature to be provided by the heater. The user input device 207 may be, for example, a button, a switch, or a touchscreen display. The heater 203 may include one or more heating elements.
[0375] The humidifier base is configured to receive a humidifier cavity 251. The humidifier cavity 251 includes a housing 253 defining an internal liquid reservoir 254, an upstream gas inlet port 255 in fluid / pneumatic communication with the liquid reservoir, a downstream gas outlet port 257 in fluid / pneumatic communication with the liquid reservoir, and a base 259. The base 259 is arranged to be positioned on or above a heater 203 to heat the liquid in the liquid reservoir. The base may include a flange 261 projecting outward from an adjacent portion of the housing 253 to aid in positioning the humidifier cavity appropriately on the humidifier base.
[0376] Gas inlet port 255, liquid reservoir 254, and gas outlet port 257 are in fluid / pneumatic communication to provide a gas flow path from gas inlet port 255 through or across the liquid reservoir to gas outlet port 257 to heat and humidify the gas traveling along the gas flow path.
[0377] The humidifier chamber 251 can be any suitable chamber that holds a suitable liquid (e.g., water) for humidifying the gas. The humidifier chamber 251 can be a manually filled chamber and can be filled via a liquid inlet port 263. Alternatively, the humidifier chamber 251 can be an automatically filled chamber, and liquid can be supplied to the humidifier chamber from a liquid container, bag, or other liquid source. The humidifier chamber may include a float valve in a liquid reservoir configured to control the flow of liquid from the liquid container into the liquid reservoir.
[0378] Gas delivery conduit 301 is located upstream of humidifier chamber 251. Gas delivery conduit 301 is in fluid / pneumatic communication with humidifier chamber 251, or is configured to be in fluid / pneumatic communication upstream of humidifier chamber 251 (i.e., downstream of humidifier chamber 251). Gas delivery conduit 301 is configured to receive one or more gases from a gas source and deliver the gas to gas inlet port 255 of the humidifier chamber.
[0379] The gas delivery conduit 301 has an upstream gas inlet port 303 at one end of the conduit and a downstream gas outlet port 305 at the opposite end of the conduit. The gas inlet port 303 and the gas outlet port 305 are in fluid / pneumatic communication to provide a gas flow path from the gas inlet port 303 through the gas delivery conduit to the gas outlet port 305. The gas outlet port 305 of the gas delivery conduit and the gas inlet port 255 of the humidifier chamber 251 may include complementary coupling features to allow the gas delivery conduit 301 to be coupled to the humidifier to provide fluid / pneumatic communication between the gas delivery conduit 301 and the humidifier chamber 251. The complementary coupling features of the gas outlet port 305 of the gas delivery conduit 301 and the gas inlet port 255 of the humidifier chamber 251 may be disconnectable from each other, allowing the gas delivery conduit 301 to be disengaged from the humidifier chamber 251. Alternatively, the complementary coupling features may be permanently or semi-permanently coupled.
[0380] Regarding the complementary connection features, at least some of them may be provided by an adapter insert, such as an adapter insert 900 including a male connection finger 901.
[0381] The gas inlet port 303 of the gas delivery conduit may be equipped with one or more connection features to enable the gas delivery conduit to be connected to the gas source.
[0382] An inspiratory conduit 401 extends from a humidifier chamber 251, thereby connecting the humidifier to a patient interface 601 via a series filter 501. The inspiratory conduit 401 may include a conduit heater 403 adapted to heat the gas passing through it. The heater 403 helps minimize or prevent the formation of condensation in the inspiratory conduit, which could otherwise occur due to the temperature difference between the inside and outside of the conduit wall. In other configurations, the conduit heater 403 may be absent. The inspiratory conduit 401 includes an upstream gas inlet port 409 at one end of the conduit and a downstream gas outlet port 405 at the opposite end of the conduit, wherein the conduit defines a gas flow path from the gas inlet port 409 to the gas outlet port 405.
[0383] The humidifier chamber 251 is in fluid / pneumatic communication with the intake duct 401 upstream of it, or is configured to be positioned to be in fluid / pneumatic communication with the intake duct 401 upstream of it (i.e., with the intake duct positioned downstream of the humidifier chamber 251). The gas outlet port 257 of the humidifier chamber 251 and the gas inlet port 409 of the intake duct 401 may include complementary coupling features to allow the intake duct to be coupled to the humidifier to provide fluid / pneumatic communication between the humidifier chamber 251 and the intake duct 401. These complementary coupling features may be disconnectable from each other, allowing the intake duct 401 to be disconnected from the humidifier chamber 251. Alternatively, these complementary coupling features may be permanently or semi-permanently coupled.
[0384] The inhalation conduit 401 typically has a longer length than the gas delivery conduit 301.
[0385] Filter 501 includes a generally cylindrical filter housing 503 having an enlarged central body portion. The leading edge of the enlarged central body portion includes a tapered wall terminating at an upstream gas inlet port 505, and the trailing edge of the enlarged central body portion terminates at a downstream gas outlet port 507. The gas inlet port 505 and the gas outlet port 507 are in fluid / pneumatic communication via the central body portion. The filter may be a high-efficiency particulate air (HEPA) filter. The enlarged central portion of the filter housing contains a suitable filter material. For example, the filter material may include pleated paper, nanofibers, or any other suitable filter material, including sock-bag filters, disc filters, spiral filters, single or multiple media blocks, multiple or multiple media discs having a fluid flow of media flowing freely from the disc into and out of the disc. The filter captures and prevents particulates, bacteria, and / or other infectious substances from being passed downstream of the inspiratory conduit to the patient, and captures and prevents bacteria and / or other infectious substances from being passed upstream of the patient into the inspiratory conduit.
[0386] Reference here Figures 5 to 6D An exemplary filter is described. Alternatively, the filter can be any other suitable type.
[0387] The inhalation conduit 401 is in fluid / pneumatic communication with the filter 501 upstream of the filter, or is configured to be positioned to be in fluid / pneumatic communication with the filter (i.e., with a filter located downstream of the inhalation conduit) upstream of the filter. The gas inlet port 505 of the filter 501 and the gas outlet port 405 of the inhalation conduit 401 include complementary coupling features to allow the inhalation conduit to be coupled to the filter to provide fluid / pneumatic communication between the inhalation conduit and the filter. The complementary coupling features of the gas inlet port 505 of the filter and the gas outlet port 405 of the inhalation conduit are disconnectable from each other, allowing the inhalation conduit 401 to be disconnected from the filter 501.
[0388] In one configuration, the complementary connection features between the gas outlet port 405 of the inspiratory conduit 401 and the gas inlet port 505 of the filter include a 22mm medical connection or a 22mm medical tapered connection. Figure 3 An electrical connection 407 is shown at the gas inlet port 409 of the inhalation duct. This electrical connection can provide an electrical connection to the heating wire of the inhalation duct, or via it, to any associated component of the inhalation duct or other part of the kit or assembly. The electrical connection can also provide connection to signal, communication, or sensor lines.
[0389] Filter 501 is in fluid / pneumatic communication with patient interface 601 upstream of the patient interface, or is configured to be placed in fluid / pneumatic communication with patient interface 601 upstream of patient interface 601 (i.e., with the patient interface located downstream of the filter). In one configuration, filter 501 is coupled to patient interface 601, or is configured to be coupled to patient interface 601.
[0390] The patient interface 601 includes a patient interface gas conduit 603 having an upstream gas inlet port 605 at one end. The opposite downstream end of the patient interface gas conduit 603 is in fluid / pneumatic communication with the patient cannula 30 / 607 to deliver gas from the patient interface gas conduit 603 to the patient P.
[0391] In one configuration, the gas outlet port 507 of the filter 501 and the gas inlet port 605 of the patient interface gas conduit include complementary coupling features to enable the filter 501 to be coupled to the patient interface 601 to provide fluid / pneumatic communication between the filter and the patient interface gas conduit, the filter being connected in series with a gas flow path through the patient interface gas conduit. The complementary coupling features may be disengaged from each other, allowing the filter to be disconnected from the patient interface gas conduit of the patient interface. Alternatively, the complementary coupling features may be permanently or semi-permanently coupled.
[0392] In one configuration, the complementary connection feature between the gas outlet port 507 of the filter 501 and the gas inlet port 605 of the patient interface 601 includes a 22mm medical tapered connection.
[0393] In an alternative configuration, patient interface 601 includes patient interface gas conduit 603, and filter 501 is integrally formed with patient interface gas conduit to provide fluid / pneumatic communication between filter 501 and patient interface gas conduit 603, wherein the filter is connected in series with a gas flow path through the patient interface gas conduit. That is, the filter and patient interface can be an integrated unit.
[0394] In another alternative, the complementary connection feature may be provided at least in part by an adapter insert (e.g., the male connector 901 of adapter insert 900). This male connector 901 may provide the first complementary connection feature, while the other complementary connection feature may be provided by another component, such as the end of component 805 (all of which may be provided by another component, such as the male connector 901 of adapter insert 900). Figure 6E (As shown). In this way, a filter (e.g., filter 501) can be suitably adapted to be equipped with complementary connection features, thereby allowing such a filter to be connected and disconnected from the breathing circuit as needed.
[0395] In one configuration, multiple filters, each provided in series (e.g., "common filters" as previously described herein), can be used with a nasal cannula, nasal mask, or other patient interface. The multiple filters, arranged in series to form the common filter, can receive a flow of gas from the inspiratory catheter at the inlet port of the common filter. The outlet port of the common filter can be pneumatically connected to a patient interface for delivering gas filtered by the common filter to the patient.
[0396] Patient interface 601 is shown as a nasal cannula, although it should be understood that other patient interfaces may be suitable in some configurations. For example, in some configurations, the patient interface may include a sealed or unsealed interface and may include a nasal mask, face mask, oronasal mask, full face mask, nasal pillow mask, nasal cannula, endotracheal tube, tracheostomy tube, and combinations of the above or some other gas delivery systems. In embodiments, patient interface 601 includes an unsealed interface such as a nasal cannula, which allows gas exchange with the environment. For example, an unsealed cannula allows the removal and / or clearance of carbon dioxide from the patient's airway when the patient receives flow therapy from the system. Furthermore, in embodiments, the patient interface is in the form of a nasal interface so that the system does not interfere with other oral airway devices and / or apparatuses (e.g., endotracheal tubes in intubation procedures). Accordingly, the patient can continue to receive flow therapy throughout the intubation procedure.
[0397] The patient interface gas conduit 603 forms a first gas lumen defined by a tubular wall. The first gas lumen is adapted to be used via… Figure 2 The inhalation tube 401 and filter 501 shown receive gas from the respiratory therapy system and direct the gas to the patient P.
[0398] The first gas cavity shown is at least partially defined by a wall that can guide the gas.
[0399] The first gas lumen may optionally include a reinforcing element adapted to strengthen the first gas lumen and / or increase its stiffness to prevent deformation or collapse of the first gas lumen due to forces applied to it. The reinforcing element may include various structures, including but not limited to plastic or metal reinforcing beads located in or on the wall of the first gas lumen. Alternatively, in some configurations, the lumen may include weakened sections or sections that cannot self-maintain their flow path or fluid flow channel to allow a cover to seal onto a patient interface (e.g., a nasal cannula or nasal mask) and reduce or prevent gas flow to the patient interface.
[0400] The first gas lumen 603 is in fluid / pneumatic communication with the flow manifold 609. The flow manifold 609 receives gas from the first gas lumen 603 and delivers it to one or more nasal delivery elements 611 (e.g., the nasal fork of a nasal cannula). The one or more nasal delivery elements 611 extend outward from the flow manifold 609. The one or more nasal delivery elements 611 are adapted to be non-sealed in one or more nostrils of the patient P.
[0401] As shown in the figure, in one example, the patient interface 601 may include two nasal delivery elements 611 adapted to be positioned in each of the patient's nostrils. The shape and angle of each nasal delivery element 611 may be determined such that it extends inward toward the nasal septum of the patient's nose.
[0402] Furthermore, the shape and angle of each nasal delivery element can be determined such that each nasal delivery element points towards the posterior part of the patient's head during use. Figure 2 and Figure 3 In the illustrated embodiment, the flow manifold 609 receives flow from one side of the flow manifold 609 (e.g., relative to an imaginary vertical plane bisecting the face of patient P) and directs the flow to each nasal delivery element 611. In other configurations, the patient interface 601 may include more (e.g., three or four) or fewer (e.g., one) nasal delivery elements 611.
[0403] In other configurations, each nasal delivery element 611 may have different characteristics. For example, one of a pair of nasal delivery elements 611 may be relatively long, and the other nasal delivery element 611 may be relatively short. In some configurations, the flow manifold 609 may be configured to receive from both lateral sides of the flow manifold 609 (e.g., from the 'left' and 'right' sides of the flow manifold 609, and not just as... Figure 2 The flow is directed to the 'left side' of the flow manifold 609 shown. In some such configurations, multiple gas lumens may be used to provide pneumatic communication between the flow manifold 609 and the respiratory therapy system. In some configurations, the flow manifold 609 may be configured to receive flow from a non-lateral side of the flow manifold 609 (e.g., from the 'bottom' or 'top' of the flow manifold 609).
[0404] In other configurations, as described above, the manifold can be a separately attached component to the body of the interface (e.g., a nasal cannula or nasal mask). Such a manifold can be a completely independent component capable of detaching from the interface, or detaching from the operating position to allow for reorientation of the manifold (and associated supply catheter) relative to the interface. For example, the manifold can be a push-fit arrangement that is pushed to engage with the interface body, or it can be a rotatable connection to the interface body to allow for reorientation. Reorientation allows the supply catheter to be positioned to the left or right of the interface (and thus from one side of the patient to the other). This can allow for improved convenience or arrangement of components in a system for delivering gas to the patient. For example, if those assisting with the medical procedure need to approach the patient from a particular side, the manifold can be reoriented, and the supply catheter can be repositioned to extend from the opposite side of the patient. Such an arrangement allows for relatively inconvenient use of the patient interface and its associated components away from the healthcare worker.
[0405] When the patient interface is in the form of a nasal cannula, it can utilize a headgear with a branching strap configuration (i.e., it can be configured with weak lines or other segmented arrangements) to allow the headgear or its straps to be reconfigured from a single strap arrangement into a branching strap arrangement.
[0406] When the patient interface is in the form of a nasal cannula, it may utilize a pair of side arms extending from the body (to which the manifold is to be connected). The side arms may include features that allow the gas supply tube to be held, secured, or positioned on the side arms (to prevent uncontrolled back-and-forth movement of the gas supply tube).
[0407] The patient interface 601 may also include mounting and / or support components, such as cheek supports, for attaching and / or supporting the gas lumen 603 and / or cannulas 30 / 607 to the patient's face. For example, a releasable connection system may be used to position or place the interface on the patient's face, but allows for relatively quick removal or repositioning of the interface if necessary.
[0408] The filter can be connected to an interface tube, such as a patient interface gas conduit or gas lumen, which is connected to the manifold. The patient interface gas conduit or gas lumen can be a short section of a tube or conduit. For example, the patient interface gas conduit or gas lumen can be about 20 cm to about 50 cm long, or about 25 cm to about 40 cm long, or about 30 cm to about 35 cm long, or about 32 cm long.
[0409] Figure 3Also shown is a component 410 located on or around a conduit, such as an inhalation conduit 401. Component 410 is adapted to engage with a conduit such as an inhalation conduit 401 and is equipped with grippers 413 extending from the body 411 of component 410, the grippers 413 being adapted to hold an article in use and thereby support the conduit, such as the inhalation component 401.
[0410] Grippers 411 may be a pair of opposing grippers for holding items, such as sheets or clothing or other items or objects (e.g., medical brackets or components attached thereto) (not shown). The grippers 411 of component 410 may interact with each other in the closed position.
[0411] The body of the component may substantially surround the periphery of the conduit or tube in which it is located.
[0412] The ability to position medical tubing (such as inhalation tubes or cannulas) relative to the user has certain advantages. The ability to help support the weight of medical tubing connected to a device associated with the user has numerous advantages, including, but not limited to, reducing the weight transferred to the user or the device associated with the user, which in turn can affect the efficiency of treatment provided to the user or the overall comfort experienced by the user when using such a device.
[0413] Additionally, when a user moves or repositions their body relative to a medical conduit or associated device, strain can be transferred to the conduit or, via the associated device, to the user. Relatively quick and efficient repositioning or relocation of the conduit to provide support again would be useful.
[0414] Such a component 410 can be used to position or place, for example, aspiratory medical tubing or other tubing associated with such a medical circuit.
[0415] Therefore, component 410 is provided for use with a tube or conduit (e.g., an inhalation conduit 401). Component 410 generally includes the outer surface of the conduit or tube (e.g., the outer surface of a bellows, for example...). Figure 3 (As shown) an engageable body 411. Component 410 includes a pair of grippers 413 extending from the body 411. The grippers 413 can be used to attach to an article (not shown) or to hold an article.
[0416] like Figure 3 As shown, the body 411 includes a shoulder portion 412 associated with each of a pair of grippers 413, the shoulder portion 412 providing a surface for actuation by a user. The shoulder portion 412 is an enlarged area of the body 413. The dimensions of the shoulder portion 412 can be determined for actuation by a user's fingers or a fingerboard.
[0417] It should be understood that the body 411 is configured to be generally annular around the outer surface of the said or respective tubes or conduits (e.g., inhalation conduit 401) on which it will be associatedly disposed.
[0418] Component 410 may be a clamp capable of engaging with the outer surface or surface of a conduit or tube (e.g., an inhalation conduit 401), wherein the clamp additionally includes a pair of jaws 413 adapted for gripping an article, such that the conduit or tube can be supported when the jaws 413 of the clamp grip the article. Component 410 may be described, for example, by PCT / NZ2012 / 000169 (disclosed as WO2013 / 073970), the entire contents of which are incorporated herein by reference.
[0419] Kits and Usage
[0420] Figure 3 The diagram illustrates the form in which the components of the device will be provided to a patient for use. The described components will be provided as a kit within a package comprising [components / materials]. Figure 3 The dashed lines indicate a sealed container or bag. The packaging may be, for example, a clamshell package. The container or bag will contain a humidifier chamber 251, a gas delivery conduit 301, an inhalation conduit 401, a filter 501, and a patient interface 601. Optionally, a clamp (e.g., component 410) may also be provided in such packaging. The clamp may be provided for attaching, or already attached to, the inhalation conduit 401 (and may be positioned or placed, for example, near the patient end of such conduit), to secure the conduit to an item (e.g., bedding) to help reduce circuit load or support circuitry on the patient's face, thereby reducing the risk of the interface detaching from the patient.
[0421] Optionally, an adapter (e.g., a fitting insert 900) may also be provided in such a package. The adapter (e.g., fitting insert 900) can be used to facilitate connection between components of the system. Optionally, the inlet and / or outlet of the conduit in the system may include engagement features (e.g., engagement features of another connector 805) that can function to engage with features of the adapter.
[0422] One or more of the components may be provided separately in the package, meaning they will not be coupled together. In one configuration, the filter 501, humidifier chamber 251, inhalation conduit 401, and gas delivery conduit 301 are provided separately in the package. The patient interface 601 and filter 501 may be provided separately in the package (i.e., not coupled or integrated). Alternatively, the patient interface and filter may be coupled in the package, or the filter may be integrally formed with the patient interface gas conduit of the patient interface.
[0423] Different components may be provided in their respective arrangements of proper connection or connection with each other, or in arrangements of disconnection or disconnection, or variations thereof. For example, it may be appropriate to provide a patient interface and filter in a connected arrangement (e.g., via gas delivery conduit 301) in the package, but these components may not be provided as connected to humidifier chamber 251 or inhalation conduit 401. In another arrangement, the inhalation conduit 401 component may be provided in a connection arrangement with the gas inlet of humidifier chamber 251. Furthermore, those components intended for interchangeability between patients, such as patient interface 601, gas delivery conduit 301, and filter 501, may be provided in separate sections of the package; while those sections that will remain in the circuit despite multiple patients receiving treatment or procedures (e.g., those upstream of the filter, such as humidifier chamber 251 and inhalation conduit 401) may be provided in another separate section of the package. Discrete or separate components in the package can help maintain the cleanliness of different components until they are needed.
[0424] Methods for assembling breathing circuits using the aforementioned device, and use of the aforementioned device.
[0425] The aforementioned device allows multiple patients to reuse the gas delivery tubing 301, the inhalation tubing 401, and the humidifier chamber 251. The filter 501 prevents individual patients from contaminating the inhalation tubing 401. Each patient will have their own filter 501 and patient interface 601.
[0426] The first patient will be provided with [services] within a specific time period. Figure 3 The packaging shown. This time period is an acceptable time period in a medical setting for the reuse of the inhalation tube 401, humidifier chamber 251, and gas delivery tube 301.
[0427] use Figure 3The method for assembling a breathing circuit in the packaging will include: positioning a gas delivery conduit 301 upstream of a humidifier chamber 251 and downstream of a gas source, and connecting the gas delivery conduit 301 to the gas source (e.g., connecting the gas delivery conduit to a wall gas source such as a gas port GP via a flow controller such as a flow control valve or control knob) and connecting it to the humidifier chamber 251; positioning the humidifier chamber 251 on a humidifier base 201; positioning an inhalation conduit 401 downstream of the humidifier chamber 251 and connecting the inhalation conduit 401 to... The process proceeds to humidifier chamber 251; filter 501 and patient interface 601 are positioned downstream of inhalation conduit 401, and filter 501 is connected to inhalation conduit 401, and if not already connected, to patient interface 601; patient interface 601 is positioned on the patient; gas from the gas source is received at humidifier 251, the gas is humidified, the humidified gas from humidifier 251 is received at filter 501, and the humidified gas is delivered from the filter to patient interface 601. It should be understood that the steps of the method can be performed in any suitable order or simultaneously.
[0428] The assembled device can be used to deliver gas to a patient during pre-oxygenation, when the patient is anesthetized, and / or when the patient is already anesthetized (i.e., during respiratory arrest). For example, when the patient is already anesthetized, the device can be used to deliver a heated, humidified, high-velocity gas flow at a flow rate between 5 L / min and 150 L / min, advantageously at least about 70 L / min, but also possible at least about 50 L / min. When patients are anesthetized, their respiratory dynamics are impaired, and they do not breathe spontaneously. The high flow rate allows the patient's oxygen level to be maintained at a safe level. This provides a useful alternative to masks and bags commonly used for artificial ventilation of patients.
[0429] The method can be used, alternatively, when the patient is pre-oxygenated before anesthesia. At this time, the patient is breathing spontaneously. Pre-oxygenation is performed to increase the oxygen concentration in the patient's lungs.
[0430] In both cases, the temperature of the gas delivered to the patient can advantageously be about 37°C, and the humidity can be about 44 mg / L H2O.
[0431] Connect the same kit to subsequent devices
[0432] Once the medical procedure for the first patient has been completed, filter 501 and the resulting patient interface 601 will be disconnected from the inhalation tube 401. Filter 501 and patient interface 601 can then be discarded. Alternatively, if it is expected or apparent that the patient will require further respiratory support, patient interface 601 can remain on the patient, and filter 501, connected to patient interface 601, can then be connected directly or indirectly to another gas source. Alternatively, if the filter is not in use or if further connection to reusable components is not required, the filter can be removed. For example, another gas source can be provided elsewhere in the medical facility, such as in a post-surgical recovery room.
[0433] Then another kit was connected to the same humidifier / inhalation duct.
[0434] After the first filter 501 has been disconnected from the inhalation tubing 401, another device, including a new filter 501 and a new patient interface 601, can be connected to the inhalation tubing to make the gas delivery tubing 301, humidifier chamber 251, and inhalation tubing 401 available for a subsequent patient. Specifically, the user will position the new filter 501 downstream of the inhalation tubing 401 and will connect the filter 501 to the inhalation tubing 401. If not already connected, the user will connect the filter to the patient interface. The method then involves: positioning the new patient interface 601 on the patient; receiving gas from the gas source at the humidifier 251, humidifying the gas, receiving the humidified gas from the humidifier 251 at the filter 501, and delivering the humidified gas from the filter to the patient interface 601. It should be understood that the steps of the method can be performed in any suitable order or simultaneously.
[0435] For subsequent patients, a similar process can be repeated: disconnect the used filter 501 and patient interface 601 from the inspiratory tube 401, and then connect the new filter 501 and the resulting new patient interface 601 to the inspiratory tube 401.
[0436] At the end of a specified period (e.g., a day), the humidifier chamber 251, gas delivery conduit 301, and intake conduit 401 can all be disengaged and discarded, and can provide, for example Figure 3 The new packaging shown will be used in the next period.
[0437] Because the gas delivery tube 301, humidifier chamber 251, and inhalation tube 401 can all be used multiple times on multiple patients (due to the presence and placement of filter 501), most new patients will only require a new filter 501 and a new patient interface 601. These two components will be supplied as a kit in a package comprising a sealed container or bag. The package may be, for example, a clamshell package. The container or bag may be airtight, and its contents may be sterile. The container or bag will contain filter 501 and patient interface 601. Such a package is as follows: Figure 4 As shown.
[0438] Patient interface 601 and filter 501 can be Figure 4 The patient interface 601 and the filter 501 are provided separately in the package. Alternatively, the patient interface 601 and the filter 501 may be coupled in the package. Alternatively, the filter may be integrally formed with the patient interface gas tube of the patient interface.
[0439] Figure 4 The use of the patient interface 601 and the filter in the packaging will be as described above.
[0440] The patient interface 601 and filter 501 are intended for use by a single patient or user, but can also be used to deliver gas from one or more devices, for example, for use by a patient before and / or during anesthesia and / or during postoperative recovery.
[0441] Another kit may include a gas delivery tube 301, an inhalation tube 401, and a humidifier chamber 251, but excluding a filter 501 or a patient interface 604. Similarly, this kit may be housed in a package of the type described above, and the components may be supplied together or separately.
[0442] Different types of kits can be supplied together or separately. For example, a single package may contain two or more kits of the same or different types.
[0443] Exemplary Filter
[0444] Figures 5 to 6D An exemplary filter 501 that can be used in the device is shown. (Reference) Figure 5The filter has a filter housing F1 formed by a first housing portion F2 and a second housing portion F3. The first housing portion and the second housing portions F2 and F3 are joined at their respective peripheries F4 and F5. The periphery F6 of a mesh F7 of filter media is sandwiched between the peripheries F4 and F5 of the first portion and the second housing portions F2 and F3. Each of the first housing portion and the second housing portion F2 and F3 includes one of an inlet port F8 and an outlet port F9. The inlet port and the outlet port are substantially indistinguishable and interchangeable. An insulating outer wall F10 is configured as a cover covering the main filter medium, sealing the body of the filter housing F1.
[0445] A pair of enclosed air spaces F11 and F12 are formed between the filter housing F1 and the surrounding outer wall F10. These enclosed air spaces F11 and F12 isolate the filter housing F1 from the environmental conditions outside the surrounding outer wall F10. The surrounding outer wall F10 is formed by a pair of cover sections F13 and F14, which have a snap-fit connection with each other at their peripheries F15 and F16. Each cover section F13 and F14 has a corresponding collar F17 and F18 respectively fitted onto the inlet port F8 or the outlet port F9. Each collar F17 and F18 has an extension F19 and F20 extending toward the mesh F7 of the filter medium to abut against the surfaces F21 and F22 of the corresponding housing portions F2 and F3 extending outward from the ports F8 and F9 in the direction of the mesh F7 of the filter medium.
[0446] exist Figure 5 As can be seen, in the form shown, the filter is rotationally symmetric, so any cross-section on the longitudinal plane will appear as... Figure 5 As shown. Of course, the filter can be constructed in a more rectangular shape with, for example, a mesh F7 for the filter media and associated peripheries F4, F5 for the housing portions F2, F3, wherein walls F21, F22 converge between the peripheries F4, F5 and the circular peripheries of the inlet and outlet ports F8, F9.
[0447] In some applications, it is preferable that the filter has more than one port on one or more sides of the filter medium, for example, two ports on the gas supply side of the filter medium and a single port on the patient side of the filter medium. In this case, the two ports may be, for example, side by side, or alternatively, coaxial ports for connection to a coaxial tube or disconnector. In a coaxial arrangement, the configuration of the filter housing and the isolation cap can be as simple as... Figure 5 As shown. In a side-by-side configuration, the corresponding filter housing portion will have a pair of ports and a corresponding cover section, which fit tightly onto the pair of ports via a pair of orifices or openings.
[0448] The main components of the filter (excluding the filter media) can be formed from suitable plastic materials, particularly those approved for medical use. For example, the first housing portion and the second housing portions F2, F3, and the cover sections F13, F14 can be injection molded from medical-grade polypropylene material. The filter media can vary depending on the intended application to include, for example, antimicrobial properties or simply as a particulate filter. In the latter case, the filter media can be, for example, a nonwoven felt of electrostatically charged polypropylene fibers, such as that sold by All Felt Incorporated under the trademark ELECTROSTAT. Another alternative example of a suitable filter media can be, for example, a pleated sheet made of glass microfibers or paper, or any other type of filter media disclosed herein.
[0449] Other examples of filter media types include: ceramics, woven metals (e.g., woven fabrics), porous plastics (e.g., but not limited to plastic powders molded into porous rigid shapes), and nonwoven media (e.g., dry-molded, wet-molded, or membrane-type).
[0450] Other examples of filter media materials may include: cellulose, cotton, wood pulp, glass, glass fiber, glass microfiber, or composite materials, polymers, metals, such as polytetrafluoroethylene (PTFE), polycarbonate (PC), acrylics including modified acrylic fibers, synthetic fibers, fluoropolymers, thermoplastic polyurethane (TPU), polyethylene (PE), polyamide, polyester, polypropylene (PP), nylon, and metals such as galvanized steel, stainless steel, aluminum, and copper.
[0451] Composite materials can consist of the following: polyamide, polyethersulfone, polysulfone, ceramics, carbon, or any other polymer listed above, such as polytetrafluoroethylene (PTFE), polycarbonate (PC), acrylics, synthetic fibers, fluoropolymers, thermoplastic polyurethane (TPU), polyethylene (PE), polyamide, polyester, polypropylene (PP), and nylon. Composite materials can be multilayered because they have a multi-layered structure. Individual layers can have different functions (e.g., support or reinforcement layers), different filtration efficiencies, or pore sizes for gas absorption, in order to contain particles and / or contaminants within the inner or different layers of the composite filter.
[0452] It will also be understood that the filter media may be or include electrostatic, hydrophilic or hydrophobic properties or characteristics.
[0453] The connection between the first housing portion and the second housing portions F2, F3 can be achieved through a permanent adhesive process to ensure a proper seal between the two portions. For this purpose, the first and second portions F2, F3 each have overlapping flanges F24, F23, and these flanges provide surfaces that can be joined by suitable adhesives or by ultrasonic welding in a known manner. For the periphery F6 of the mesh F7 of the filter medium sandwiched between the peripheries F4, F5 of the first housing portion and the second housing portions F2, F3, one or more suitable ridges F25 can be provided on one of the housing portions F2, F3 (in this case, the second housing portion F3).
[0454] As described above, in use, the filter can be connected between the inspiratory conduit 401 and the patient interface 601, located between the two long sides of the breathing circuit. The patient interface tube 603 can be, for example, a ventilator to prevent or remove condensation and to deliver gas to the patient at approximately 37°C. The enclosed space F26 within the filter 501 is substantially isolated from the external environmental conditions of the outer wall F10, significantly reducing condensation formation on the filter wall within the filter. In an alternative configuration, one or more orifices (not shown) can be provided at position F50 in the walls F21 and / or F22 of the housing portions F2 and F3 adjacent to their peripheral flanges F4 and F5, such that if a sufficient number of such orifices are provided, any liquid accumulation in the space F26 will flow through these orifices into the cavities F11 and F12.
[0455] The isolation filter 501 has a simple construction. (See reference) Figures 6A to 6D This construction is illustrated. The filter involves five simple components: a first housing portion and second housing portions F2 and F3, a mesh for the filter media F7, and cover sections F13 and F14 forming the outer wall. Figure 6A The first step of assembly is depicted in the cross-sectional side view. Housing portions F2 and F3 are joined together as indicated by arrows F26 and F27 to clamp the periphery F6 of the filter media mesh F7 between the outwardly extending peripheral flanges F4 and F5 of housing portions F2 and F3. An annular protruding rib F25 on the forward-facing surface of the peripheral flange F5 of housing portion F3 clamps the periphery F6 of the filter media mesh F7 and presses it against the peripheral flange F4 of housing portion F2. Thus, the assembled filter housing... Figure 6B As shown in the side view. Therefore, in the state shown, the peripheral flange F28 of the housing formed by the peripheral flanges F4 and F5 is subjected to ultrasonic welding to firmly and sealingly join the housing portions F2 and F3 together.
[0456] Then see Figure 6CA first cover section F13 is introduced, having a collar F19 that extends over or surrounds the inlet port F8 of the filter housing F1. A second cover section F14 is introduced such that its collar F20 extends over or surrounds the outlet port F9. The first cover section and the second cover sections F13, F14 are joined together in the directions indicated by arrows F29, F30, such that the frontally facing peripheral flanges F15, F16 overlap, and that the complementary mating surfaces formed thereon engage with each other to connect the cover sections F13, F14 to each other.
[0457] The filter, including the isolation cap, is a fully assembled unit. Figure 6D It is depicted in the side view.
[0458] Based on the description herein, and when provided in conjunction with those embodiments described herein or independently of those embodiments, an alternative filter arrangement 701 for use in a respiratory support system for delivering gas to a user or patient is disclosed. Figure 6E , Figure 6F and Figure 6N The filter arrangement 701 shown has a similar configuration to the filter 501 described herein. Therefore, additional details regarding the filter arrangement 701 can be found in the details of the filter 501.
[0459] This filter arrangement 701 includes a filter housing 703. The filter housing 703 has a gas inlet port 707 and a gas outlet port 705. At least one (or both) of the inlet port and / or outlet port 707, 705 is adapted to connect to another component 805 (e.g., a connector located at the end of a conduit) via one or more (especially a pair) male connectors 901. The male connectors 901 extend outward from one or both ports.
[0460] For example, the male connection finger 901 can be configured to extend from the gas outlet port 705 or the gas inlet port 707 of the filter arrangement 701, or from both ports 705 and 707.
[0461] like Figure 6E-6N As shown more specifically, one or each of the gas inlet port or gas outlet port 707, 705 may include an adapter insert 900.
[0462] The adapter insert 900 is configured to facilitate connection with another component (e.g., a connector located at the end of a conduit), such as to the gas inlet port 605 of another component. Figure 4 As shown.
[0463] The adapter insert 900 includes one or more (particularly a pair) male connecting fingers 901. The male connecting fingers 901 extend from a first end 902 of the adapter insert.
[0464] The male connector 901 may optionally include a notch or recess (or even the entire window) 915. These recesses 915 may be shaped to suitably engage a protrusion or projection 820 located on or provided on another component 805 that will receive the male connector 915.
[0465] The adapter insert 901 includes one or more retaining members 903 disposed at a second end 904 of the adapter insert 900. Each retaining member 903 is configured to substantially engage with an inner surface portion 709 of the filter housing 703.
[0466] Each retaining member 903 is configured to engage with the inner surface 709 of the filter housing 703 to retain the adapter insert 900 within the port into which the adapter 900 will be inserted (e.g., either or both of these ports indicated as article 707 or 705).
[0467] In use, when engaged with the inner surface 709 of the filter housing 703, each retaining member 903 is used to prevent axial displacement (e.g., disengagement) of the adapter insert 900 to prevent it from moving toward the outer end 711 of the port where the adapter insert 900 is located.
[0468] Each retaining member 903 may be configured to include at least a hook or other surface protrusion to more forcefully engage or lock the inner surface 709 of the filter housing 703.
[0469] In different embodiments, there may be one or more retaining members 903, or multiple retaining members 903, or two retaining members 903, or in other embodiments there may be four retaining members 903.
[0470] A single retaining member 903 may be provided. However, more than one retaining member 903 may be used, and in this case, these retaining members 903 may be arranged symmetrically around the second end 904 in the form of a series or sequence, or may be formed together in an array around the second end 904, which in turn provides an array of retainers that can engage with the inner surface 709 of the filter housing 701.
[0471] A handle 905 extends between a first end 902 from which the male connecting finger 901 extends and a second end 904 from which one or more retaining members 903 extend. The handle 905 connects the first end 902 and the second end 904.
[0472] The handle 905 includes a lumen or gas flow path 912 for gas to pass between each of the first end and the second ends 902, 904. In a particular embodiment, the gas may flow in a direction from the second end 904 to the first end 902.
[0473] The lumen or gas flow path 912 may be configured and / or internally shaped to transition from a substantially wider aperture (or larger inner diameter) at the second end 904 of the adapting insert 900 to a substantially narrower aperture (or smaller inner diameter) at the first end 902. In certain embodiments, the lumen or gas flow path 912 may transition substantially gradually or have a substantially linear change between the different apertures or inner diameters between each end of the first and second ends 902, 904. Such a transitional lumen 912 (or flow channel) can help minimize or reduce resistance to the gas flow passing through it. The substantially smooth inner wall or surface of the lumen 912 can further help minimize this resistance to the gas flow.
[0474] When the adapter insert 900 is located within a port of the filter housing, the handle 905 is advantageously received substantially within or by that particular port. One or more splines or ribs 906 may be positioned along or around the handle 905. In a particular embodiment, the one or more splines or ribs 906 may extend longitudinally along the handle 905. In an alternative embodiment, one or more of the splines or ribs 906 may be configured as circumferentially (whether continuous or discontinuous) or radially expanding ribs. Regardless of whether the splines or ribs 906 have a longitudinal or circumferential orientation, in some configurations, the one or more splines or ribs 906 may extend radially outward from the handle 905 to at least partially engage or make surface contact with the inner surface 907 of the port in which the adapter insert 900 will be placed.
[0475] One or each of the one or more splines or ribs 906 can be configured to provide at least some reinforcement or structural support to the wall of the port in which the adapter insert 900 will be positioned. This can be particularly useful when such a filter (and filter housing) is used for the purposes disclosed herein, where the port from the filter housing can benefit from structural support or reinforcement.
[0476] The spline or rib 906 can provide a tapered fit between the handle and the port of the filter housing. In this way, this tapered fit can help improve the fit of the adapter insert into the port. The spline or rib 906 may tapere in one direction such that the tolerance between any such spline or rib 906 and the inner surface (e.g., wall) of the port becomes more or larger toward the second end of the adapter insert 904, and the tolerance between the spline or rib 906 and the port wall or inner surface is much smaller (or a tighter fit) at the first end of the insert 902.
[0477] The spline or rib 906 extending from the handle 905 can further help to hold the adapter insert 900 in place relative to the filter housing port where the insert will be placed, and can also provide stability for the adapter insert.
[0478] In yet another embodiment, the adapter insert 900 may additionally include one or more sealing members 908, or two or more sealing members, or in certain cases may have two sealing members.
[0479] Advantageously, at least one first sealing member 908A may be provided around the handle 905. This first sealing member 908A may be provided around a circumferential or radial region of the handle 905. This first sealing member 908A assists in forming a first sealing surface extending radially outward from the handle 905. When additional first sealing members are provided around or along the handle 905, these additional first sealing members provide additional sealing surfaces that can contact and / or form a seal with the inner surface 907 of the port to be received in the handle.
[0480] As shown in the figure, this or each of the first sealing members 908A is located between the first end 902 and the second end 904 of the adapter insert 900. In one specific embodiment, the first sealing member 908A is positioned approximately midway along the handle 905 and is configured as a circumferential seal of the O-ring type.
[0481] In another embodiment, the adapter insert 900 may provide at least a first sealing member 908A disposed around the handle 905 and at least a second sealing member 908B, the second sealing member being substantially disposed at or adjacent to a first end 902 of the adapter insert 900.
[0482] The first sealing member 908A helps to account for any gaps between the handle 905 or spline and rib 906 and the inner wall portion of the port where the adapter insert will be placed. Furthermore, by sealing against the inner surface 907, the first sealing member 908A helps to form a pneumatic seal between the adapter insert 900 and the port of the filter housing 703. This first sealing member 908A can provide a better seal between the adapter insert and the port where it will be placed than the self-ductility of an interference fit.
[0483] In one embodiment, the sealing member 908 may be positioned on the adapter insert 900 by a recess or groove 908C of appropriate shape. For example, a first sealing member 908A may be received in a recess or groove 908C in the handle 905 such that the two walls of the groove 908C secure the sealing member 908A in place. However, it should be understood that alternative systems may be used as part of other embodiments to maintain the orientation or positioning of different sealing members 908 on the adapter insert.
[0484] In another embodiment, the handle 905 of the adapter insert 900 may be sized to form a pneumatic seal with the inner wall portion of the port into which the adapter insert will be placed. The handle 905 may be sized to form an interference fit with the inner surface 907.
[0485] At least one second sealing member 908B may be substantially disposed at or adjacent to the first end 902 of the adapter insert 900. For example, in one embodiment, such a second sealing member 908B may be located or positioned substantially at or adjacent to the base 909 of the male connecting finger 901. The base 909 is located at the end of the male connecting finger 901 extending from the first end 902 of the adapter insert 900.
[0486] The second sealing member 908B can be operated or function to create a pneumatic seal with the surface of the female connector (e.g., at least one or more of the inner surface, end face, or chamfered surface of the female connector when abutting against the second sealing member). The O-ring is preferably an interference fit seal only because of the higher pressure when engaging or surface-contacting with the second sealing member and / or the male connector finger 901. Such a second sealing member can help provide a better pneumatic seal with the female connector compared to an interference fit seal alone, but the use of an interference fit seal alone is not excluded.
[0487] In another embodiment, the first end 902 of the adapter insert 900 may additionally include a radially extending lug or lip 910. In these embodiments, the second sealing member 908B may be located or positioned substantially on the upper surface of the lug or lip 910.
[0488] Such a lug or lip 910 may extend radially outward such that its outer diameter is equal to or less than the outer diameter of the port in which the adapter insert 900 will be placed. The outer diameter of the lug or lip 910 may be greater than the inner diameter of the port in which the adapter insert will be placed.
[0489] The specific maximum outer or external size or dimension of the adapter insert 900 (excluding the first sealing member 908A) can help and mean that, even when the adapter insert 900 is to be connected to the filter housing port, a 22mm tapered female connector or other component can be fitted onto the adapter insert 900 and onto the outer surface of the port in which the adapter insert will be received or placed during use (e.g., in this case, the outer diameter of the filter housing port will effectively serve as a 22mm tapered male connector). In emergency situations, this can mean that other systems can be quickly connected to the filter housing without having to remove the adapter insert itself.
[0490] The lower surface 911 of the lug or lip 910 can contact the terminal face (e.g., the surface marked 713) of the port to which the adapter insert 900 is located.
[0491] Therefore, the lower surface 911 can serve as a stop end surface to prevent the adapter insert 900 from being over-inserted into the filter housing 703 through the port. Similarly, the retaining member 903 can serve as a stop end or other feature to prevent the adapter insert 900 from being accidentally removed or detached from the port into which it is inserted. In this way, once the adapter insert 900 is configured to connect or retain with or be retained to the component or port into which it is inserted, it can be permanently retained or attached.
[0492] In different arrangements, the distance between the lower surface 911 of the lug or lip 910 and the retaining member 903 can match or can be substantially equal to the length of the port in which the fitting insert will be positioned.
[0493] The lug or lip 910 may be inserted into or clamped between the end of the handle 905 and the first end 902 of the adapter insert 900. Alternatively, the lug or lip 910 may be clamped between the base 909 of the male connecting finger 901 and the end (e.g., the first end 902) of the handle 905. In a certain configuration, the at least one second sealing member 908B is clamped between the base 909 of the male connecting finger 901 and the end of the handle 905. Alternatively, the at least one second sealing member 908B may be clamped between the base 909 of the male connecting finger 901 and the upper surface of the lug or lip 910.
[0494] Advantageously, in use, the at least one second sealing member 908B provides a second sealing surface for sealing against the surface of another component (e.g., a connector or the port of another connector) that abuts against the second sealing surface. This or each second sealing member 908B may be an O-ring type.
[0495] Regarding the second sealing member 908B, when another component is connected or engaged with the male connecting finger 901, and during use, when such a connection or engagement is established therebetween, the other component can be configured to additionally engage the second sealing member and the second sealing surface it provides. In this way, the second sealing member can operatively assist in establishing a pneumatic connection between the adapter insert and the other component. This can help improve the pneumatic connection, reduce gas loss in the breathing circuit, and consequently benefit the improved / stable delivery of the desired treatment to the end user or patient.
[0496] As described herein, the adapter insert 900, when considered not to include one or more first sealing members, may have a maximum radial outer diameter (or outer profile) equal to or less than 22 mm.
[0497] The above embodiments and configurations relate to an 'other component'. This 'other component' can be any other suitable component that can create a connection, particularly as part of a medical breathing circuit. However, it is contemplated that it is particularly preferred that the 'other component' be an end connector provided as part of another segment of the medical breathing circuit.
[0498] For example, Figure 6N An exploded perspective view shows the filter housing 703, the adapter insert 900, and another component 805. Figure 6E and Figure 6F Demonstrates the use of in-situ adapter inserts (in...) Figure 6F The filter housing (only the side of the lug or lip 910 can be observed) and the connection with another component 805. Figure 6E Is it through Figure 6F A cross-sectional view.
[0499] Figure 6G -M each independently displays the adapter insert 900.
[0500] For example, Figure 6G This is a first side view of the adapter insert 900, which includes a single first sealing member 908A and a single second sealing member 908B. Figure 6I yes Figure 6G The cross-sectional view helps to show the relative positioning of the different sealing components 908. Figure 6I Too Figure 6H A cross-sectional view along DD. Figure 6H From Figure 6G The view of the adapter insert 900 obtained by rotating the adapter insert axially by 90°.
[0501] Figure 6J With Figure 6H The same orientation shows the adapter insert 900, but helps to show the insert 900 before the sealing member 908 is placed in place. Figure 6K Showing with Figure 6J The same adapter insert 900, but rotated 90° axially. Figure 6K yes Figure 6J A cross-sectional view along EE.
[0502] Figure 6L and Figure 6M Each end perspective view shows the adapter insert 900.
[0503] The adapter insert 900 described herein can engage with ports of various components; however, it is particularly desirable to provide an adapter for the filter housing. Providing such an adapter allows for a series connection between the components of the breathing circuit and the filter body. Therefore, the series filter can be more easily and simply (and accurately and pneumatically) inserted into the gas flow path of the medical breathing circuit.
[0504] Exemplary nasal cannula
[0505] Figures 7 to 21 An exemplary configuration of a nasal cannula that can be used in the patient interface 601 of the device described herein is shown. It will be understood that a filter 501 will be disposed upstream of the nasal cannula and downstream of the inspiratory duct.
[0506] The nasal intubation assembly provides patients with a suitable interface for delivering a high-speed, high-humidity gas flow into the nasal cavity. Nasal intubation is useful in anesthesia settings because it occupies a relatively small area and is positioned above the upper lip, leaving the mouth and larynx open for surgeons to insert additional instruments with minimal obstruction or interference, or minimal obstruction or interference with procedures performed in the mouth / larynx. For patients receiving nasal intubation in such situations, the tube needs to be non-intrusive, comfortable to wear, noiseless, and suitable for wearing during sleep. The tube can also be used for other treatments, such as continuous positive airway pressure (CPAP) therapy.
[0507] exist Figure 7 and Figure 8The first form of the nasal cannula assembly 30 / 607 is shown. This nasal cannula, generally indicated by 20, includes a face mount portion 21 and a gas flow manifold portion 24. The face mount portion includes a pair of tubular nose forks 22, 23 integrally molded with or removably attached to the face mount portion 21. The gas flow manifold portion is integrally molded with or attached to the conduit 603 as described above.
[0508] As described above, the nasal cannula may be equipped with a removable and attachable manifold for delivering a gas flow to the interface, the manifold being reorientable to position the gas supply connection to the left or right side of the interface (or the patient). One or a pair of side arms of such a nasal cannula allow the interface to be positioned on the patient's face and may optionally include a relatively soft outer material or overmolded material, at least in the patient contact surface.
[0509] The removable manifold can be redirected as described above. This redirection can be done manually by the user or by someone assisting the patient / user.
[0510] The headgear disclosed herein can be provided in combination with a nasal cannula and may include at least one strap that is bifurcated (i.e., may have a weak line or other predefined area to allow the user to divide the strap into two parts).
[0511] The body of the nasal cannula may include a barrel-shaped portion into which the manifold is inserted and removable to allow for left-right interchange. The nasal cannula may additionally or optionally include headgear connectors attached to one or both side arms.
[0512] The face mount portion 21 and forks 22, 23 can be molded from silicone or other flexible materials known in the field of cannulation construction. The gas flow manifold portion 24 can be made of a rigid plastic material, but it can be manufactured from other suitable materials.
[0513] The face mount portion 21 can be integrally molded with the forks 22 and 23 and is shaped to generally follow the contours of the patient's face around the upper lip area. The inner side (not shown) of the face mount portion 21 may be equipped with the following breathable pad. An elongated elliptical recess 26 and two elliptical recesses 27 and 28 are molded in the outer side 25 of the face mount portion 21. These two elliptical recesses extend through the face mount portion 21 and each connects to a tubular channel formed in the respective tubular forks 22 and 23.
[0514] The gas flow manifold portion 24 is generally tubular in shape, having a substantially circular inlet (not shown) on one side that curves into an elongated elliptical outlet 29. The circular inlet receives the end of a conduit or pipe 603, allowing gas to be supplied to the gas flow manifold portion 24 and to flow through the inlet and out of the outlet 29. The conduit 603 may be permanently attached to the manifold portion 24 or may be releasably attached.
[0515] The outlet 29 is elongated and elliptical in shape, and is fitted into the elongated recess 26 by friction or snap-fit engagement with the manifold 21, making it necessary to apply considerable force to remove the manifold portion 24 from the elongated recess 26. Furthermore, because the face mount portion 21 is flexible and the manifold portion 24 is made of a relatively rigid plastic material, the outlet 29 of the manifold portion can be easily pushed or forced into the elongated recess 26. When the manifold portion 24 is engaged with the face mount portion 21 and in use, gas flows from the conduit 603 through the gas flow manifold portion 24 and out of its outlet 29, into the various elliptical recesses 27, 28, into the various forks 22, 23, and into the patient's nostrils.
[0516] The elongated recess 26 of the facial mounting portion and the outlet 29 of the manifold portion are symmetrical in shape and configuration, and therefore the manifold portion 24 can be switched or flipped so that the tube 603 extends from the left or right side of the patient's nostril. This means that the nasal cannula assembly 20 and the associated tube 603 are relatively less obstructive, as the cannula 20 requires only a single horizontal side inlet instead of two inlets.
[0517] The nasal cannula assembly is more comfortable to wear when it is located below the nasal septum and supports two nasal forks. Because the forks are molded from a single piece of soft material (such as silicone), they are easy to insert into the patient's nostrils and are more comfortable for the patient.
[0518] The contour of the face mount 21 is designed such that the pressure distribution within the face mount 21 forces the airflow on each nose fork to be uniform, in order to reduce the whistling sound of the airflow.
[0519] Now for reference Figures 9 to 12 The diagram illustrates a second form of the nasal cannula assembly. In this form, the nasal cannula assembly 30 / 607 has a... Figure 7 and Figure 8 The first nasal cannula assembly is of a substantially similar form and includes a face mount portion 32, a pair of nose forks 33, 34, a gas flow manifold portion 35, and a conduit 603. The face mount portion 32 and the nose forks 33, 34 can be integrally molded as a single piece from a soft plastic material such as silicone, although in other forms the face mount portion and forks can be separate but can be attached together for use.
[0520] The nose forks 33 and 34 are tubular in shape and can have a constant diameter, but can be shaped to fit the contour of human nostrils.
[0521] The strap or strap attachment device 31 may be integrally formed or attached to the face mounting portion 32 so that the nasal cannula assembly 30 / 607 can be held in place relative to the patient's face.
[0522] The face mount portion 32 has an open tubular recess 38 extending below the nose forks 33, 34, which receives a gas flow manifold portion 35 attached to or integrally formed with the tube 603. Tubular channels within the nose forks 33, 34 extend through the face mount portion and into the recess 38. The gas flow manifold portion 35 is blocked at one end 39 but attached to the tube at the other end and has an elongated opening 37 serving as an outlet for gas received from the tube 603. Due to the flexible nature of the material used to make the face mount portion 32, and because the gas flow manifold portion 35 is made of a rigid plastic material, the gas flow manifold portion 35 can be pushed through the tubular recess 38 in the face mount portion 32, and the elongated opening 37 in the gas flow manifold portion 35 engages with the tubular channels of the forks 33, 34. Therefore, in use, the gas flowing through the pipe and into the gas flow manifold section 35 exits through the opening 37 and enters the tubular channels in the forks 33 and 34, and then enters the patient's nostrils.
[0523] To assist in retaining the gas flow manifold portion 35 within the manifold recess 38, the manifold portion 35 is equipped with an inner recess 60 and wavy lip regions 58, 59. When engaged with the face mount portion 32, the tubular body forming the recess 38 is located within the inner recess 60, and the edges of the tubular body abut against the lips 58, 59 formed on the manifold portion 35.
[0524] An optional breathable pad can be supplied with any of the aforementioned nasal cannula components. Specifically, this pad 36 is... Figure 12 The second form of the nasal cannula assembly is shown in the diagram.
[0525] The pad can be attached to the inner surface of the face mount portion 32, which connects to the upper lip of the patient wearing the cannula. When the face mount portion 32 rests against the patient's face, the pad 36, made of absorbent fabric, reduces heat and moisture on the patient's upper lip.
[0526] The pad 36 can be attached to the face mount portion 32 by an adhesive. For example, the pad can be supplied with an adhesive backing that adheres to the face mount portion, so that the pad can be easily removed from the face mount portion and replaced when needed.
[0527] The pad (if present) reduces the effect of heat on the patient's skin and improves hygiene, as any contaminants or microorganisms that may grow near the patient's skin in a warm environment can be removed when the pad is removed and replaced.
[0528] Now for reference Figures 13 to 16 The third form of the nasal cannula assembly is shown, which comprises three parts.
[0529] First of all, Figure 13 The diagram shows a gas flow manifold section 40, designed for left-hand or right-hand orientation, and providing symmetrical flow to a pair of nasal cannula assembly forks 41, 42 (see [reference]). Figure 15 or Figure 16 ).
[0530] Next, a pair of soft nose forks 41 or 42 are provided, which can be attached to the top of the gas flow manifold portion 40, thus allowing the patient to use forks of various shapes and spacings. Figure 15 and Figure 16 Two forks with this configuration, 41 and 42, are shown in the figure. Figure 15 The fork 41 is a narrow, elongated tubular component 43, 44 of a substantially constant diameter that fits into the patient's nostril. The fork is integrally molded with the body 45, which can be engaged with the gas flow manifold portion 40 (see [link to body]) by appropriate means (e.g., friction or snap-fit). Figure 13 )assembly. Figure 16 The fork 42 is a tapered tubular member 46, 47 molded onto the body 48. Similarly, the body 48 can be fitted (by friction, snap-fit, or other means) to... Figure 13 The gas flow manifold section. These forks can be made of soft plastic materials such as silicon, but other suitable materials can also be used.
[0531] Because the forks are removable, they are easy to clean and can also be sterilized for a second or subsequent use on a particular patient.
[0532] Figures 13 to 16 The third part of the third type of nasal cannula assembly shown is Figure 14 The face mounting portion 49 includes a head strap 53 attached to a pad 50, which may be a substantially rigid pad formed by molding or shaping, for example, made of a plastic material (such as polypropylene). Figure 14 The pad 50 shown may include a breathable fabric pad on its surface that rests against the patient's face (as per relevant information). Figure 12 The described pad 36 is similar, or a head strap 53 may extend to the rear of the pad. The head strap 53 may be made of a flexible material such as neoprene.
[0533] Plastic pad 50 Figure 14 The image shows and includes a plurality of orifices 61 formed therein to allow heat and moisture to dissipate from the patient's facial surface. The pad 50 has fastening devices 51, 52 for holding the gas flow manifold portion 49 in the correct position on the patient's upper lip. These fastening devices may be clips 51, 52 that can be fitted into complementary recesses 54, 55, 56, 57 disposed in or on the manifold portion 40 (see Figure 50). Figure 13 However, other suitable fastening devices can also be provided for the cannula. Examples of other fastening devices are collars integrally molded as part of the fork, which wrap around the face mount portion and lock onto a protrusion on the manifold portion, thereby enclosing the face mount portion and securing the components together stably and securely. Another example of a fastening device is Velcro (a plastic nylon fastener). TM The attachment is of the type ) which attaches to one side of the manifold portion 40 and the other side to the plastic pad 50. For Figure 13 and Figure 14 The fastening device shown must have at least one recess on each side of the manifold 40. In a preferred embodiment of the nasal cannula assembly, two recesses 54, 55 are provided on one side of the manifold 40, and two other recesses 56, 57 are provided on the other side of the manifold 40.
[0534] The attachment between the face mounting portion 49 and the manifold portion 40 allows for left- or right-hand orientation of the manifold portion and associated pipes.
[0535] The cannula can be discarded after use. Alternatively, the cannula can be stored and subsequently reused on a single patient, for example, when the patient is moved from the operating room to the recovery room. The cannula can be removed and stored until it is needed during recovery. Using a single inflow cannula results in less condensation due to the reduced surface area for heat loss, and thus the cannula reduces the effect of condensation buildup in the tubing and cannula.
[0536] Typically, the unheated, flexible section of the tubing is placed proximal to the patient to reduce torque or tension at the patient interface and to minimize potential heat problems or overheating near the patient. To reduce condensation formation in the unheated tubing, tubing with vapor permeability can be provided. (See now for further details.) Figure 17 The nasal cannula (particularly the second type described herein) may be equipped with a short section of ventilated tubing 603 between the nasal cannula 30 / 607 and the heated inhalation tube 401. As described above, a filter will be provided between 603 and 401. The tubing 603 may be made of a material that allows water to pass through, such as a hydrophilic material, for example, SYMPATEX. TM .
[0537] Test results show that in a room with ambient air temperature of 22°C and 50% RH, when operating with an air input of 42.2 mg / L absolute humidity and an airflow of 10 liters per minute (LPM), the performance of the 420 mm long vent tube only reduced the absolute humidity to 41.15 mg / L at the dryer tube outlet. In contrast, under the same conditions, a 420 mm long airtight but insulated polyethylene tube also output air with a humidity of 41.15 mg / L. The measured condensation in the vent tube was significantly reduced; therefore, humidity that would otherwise be lost as condensation on the walls was dissipated through the vent wall.
[0538] The result of providing a short section of the ventilated tubing 603 is that most of the humidity in the gas is transferred to the patient, and the humidity loss through the ventilated wall of the short tubing 603 is negligible and unmeasurable, while condensation is reduced. The high-flow-rate, high-humidity system has been optimized to deliver ventilated gas therapy to the patient at near-body temperature and under conditions of full vapor saturation. It was originally expected that using an unheated ventilated tubing close to the patient to provide a highly flexible connection and avoid respiratory condensation would reduce the humidity of the gas therapy, thereby reducing its effectiveness. These results are surprising and counterintuitive, and in part explain why the ventilated tubing is used as a short section of tubing before the patient undergoes examination. This short tubing 603 is envisioned for use with any tubing that delivers heated and humidified gas to the patient.
[0539] In alternative configurations, a neck strap or lanyard can be provided together with the nasal cannula assembly. Figure 17 A tether 63 is shown. Tether 63 can be attached to tubes 401 or 603, or to filter 501 (not shown in this figure). A buckle 64 can be provided with the neck tether 63 to adjust its length. The purpose of the neck tether is to support part of the weight of tube 401 and prevent the weight of tube 401 from pulling on the nasal cannula assembly 30 / 607. This helps prevent the fork from interfering with or dislodging the very sensitive liner of the nasal passage. The loosely fitted neck tether also provides a convenient way to attach tube 401 to the patient outside a blanket. This allows the patient to turn over in bed and avoids overheating of tube 401 if placed under a blanket.
[0540] The described strap or lanyard can be used with any breathing device or interface that supplies gas to a patient, such as a nasal mask or face mask, or a tracheostomy fitting or connector. When used with such a device or interface, the strap or lanyard supports the weight of the one or more tubes or tubing that supply gas to the mask, connector, or cannula, and helps reduce tension on the mask, connector, or cannula.
[0541] Figure 20and Figure 21 A tracheostomy fitting or connector that can be used with a neck strap or lanyard is shown. The tracheostomy fitting can replace a nasal tube as a patient interface in the kits and devices described herein. Again, a filter, such as filter 501, will be provided between the patient interface (in this case, tracheostomy connector 69) or tube 71 and inspiratory tube 401. In one specific example, a particularly advantageous arrangement includes a filter 501 that is adapted by an adapter insert 900, thereby facilitating simple connection via tube 71 to the outlet of filter 501. Tracheostomy connector 69 is attached to tracheostomy mount 72, which extends through a hole in the neck of patient 68 into the tracheostomy tube (not shown) and into its airway passage. Connector 69 provides a direct connection between the tracheostomy tube and the supply of respiratory gas received via tube 71. Tube 71 can be constructed of a breathable material, similar to that described above, but can also be a heated tube.
[0542] The connector 69 has a conduit 71 directly attached thereto and also includes an exhalation port 70 that allows gas to be exhaled. During inhalation, because the gas flow to the connector 69 is greater than the patient's peak inspiratory flow, no gas flows out of the port 70. Therefore, little or no gas from ambient air is inhaled.
[0543] Excessive weight on the tracheostomy tube can lead to excessive movement of the tube, resulting in complications such as displacement or re-intubation of the tracheostomy tube, granulation tissue formation, or more serious oral erosion. To eliminate or reduce these problems, a tether or sling 73 can be attached to the catheter 71 or an additional connector 74 (which can, for example, connect the catheter 71 to an additional gas supply catheter 75). The tether or sling 73 transfers the weight of the catheters 71, 75, and connector 74 from the tracheostomy tube or connector 72 and distributes it to the patient's neck, minimizing direct load on the tracheostomy tube or connector 72. The tether or sling 73 can be adjustable, allowing the length of the tether or sling to be changed to suit the patient's needs. Alternatively, a headgear can be used to hold the tracheostomy tube. The tracheostomy tube can be used to deliver high-flow therapy. In some configurations, the tracheostomy tube has a leak connection to the patient to reduce the possibility of barotrauma or over-pressurization of the lungs when using high-flow therapy.
[0544] The orientation of the nasal cannula is crucial for patient comfort. If the nasal cannula is not securely fixed in the proper position, it may deviate, placing unnecessary stress on the inner surface of the patient's nostrils. To overcome this problem, headbands typically include a nasal cannula, but if the headband is not tight, the cannula may still shift. This type of tension can affect patient comfort when the cannula is pushed further into the patient's nose due to pressure on the head and face. Ideally, the nasal cannula should attach securely to the patient's face with minimal stress on the head and face.
[0545] refer to Figure 18 and Figure 19 A nasal cannula attachment device may be provided to hold the nasal cannula assembly 30 / 607 to the patient's face. The attachment device may be an ear loop 65, 66 attached to the strap 31 of the face mounting portion 32 of the nasal cannula assembly 30 / 607.
[0546] Loops 65 and 66 extend from the face mounting portion 32 to around the patient's ears and provide rigid anchoring when using non-elastic materials. Loops 65 and 66 may be made of thin, round cords with their ends plastically captured and adjustable. The plastic ends of the loops 65 and 66 are inserted into cavities specially manufactured in the strap 31, allowing for length adjustment to ensure a comfortable and secure fit.
[0547] In use, to assemble the nasal cannula assembly, a first loop (e.g., loop 65) is placed over one ear, positioning the nasal cannula assembly in the patient's face and nose. Then, a second loop (e.g., loop 66) is passed through the other ear, so that both loops are snugly behind the ear. This method of assembling the nasal cannula avoids the initial discomfort of air being blown into the patient's eyes when the cannula assembly is pulled down along the face for assembly of other headgear. This method of securing the nasal cannula provides a means of horizontal attachment with minimal tension applied to the ear-connecting loops. The ear loops offer an additional advantage for supine patients, as there are no straps behind the head that would move due to head movement on the pillow.
[0548] The conduit described herein can be formed from tubing. The tubing configuration can be adapted to deliver gas at high flow rates as described herein. For example, flow rates between about 45 and 150 liters per minute (LPM), or between about 10 and 120 LPM, or between about 60 LPM and about 80 LPM, or about 70 LPM.
[0549] The complementary connection features between the components of the device can be of any suitable form. For example, the features can be one or more of the following: push-fit, interference fit, latch / lock fitting, bayonet fitting, and medical tapered or medical connector. In one example, the connection feature between all components can be a 22mm medical tapered connector. Soft seals such as O-rings can be provided between the ports of the components to provide a seal at the connector or connection point. Different types of connection features can be used to connect different components, such that there is only one possible assembly configuration for the components in the system. In another form, a complementary connection feature can be provided for at least one side of the connection by an adapter insert (e.g., labeled item 900).
[0550] The gas used in the above configuration is typically oxygen. Alternatively, the gas may be air or one or more other suitable gases.
[0551] The liquid used for humidification in the above configuration is typically water. Alternatively, the liquid can be one or more other liquids suitable for the humidification process.
[0552] The devices, kits, and methods disclosed herein are particularly useful in anesthesia settings. The described configuration allows the same inspiratory tubing (and upstream components) to be used for multiple patients by simply changing the patient interface / filter combination.
[0553] In anesthesia settings, due to the risk of infection, the inspiratory tubing and patient interface need to be changed for each patient. During anesthesia, the use of the inspiratory tubing is significantly shorter than in other ventilation applications. Ventilation may occur over several days of treatment, while anesthesia typically lasts only a few hours at most. Therefore, cascading the filter with the cannula allows the user to reuse the inspiratory tubing (as well as upstream components, such as the humidifier chamber and gas delivery tubing) on subsequent patients. This complements existing practices.
[0554] In anesthesia setups, anesthesia breathing circuits are commonly observed, which attach the anesthesia system to a patient interface and are reused between patients on the same day of surgery. A filter may be placed between the circuit and the patient interface, and both the filter and the patient interface may be replaced for each patient to minimize the risk of infection. As described herein, packages or kits providing components for such circuits may be equipped with some components that are individual to a particular patient (i.e., components used only by a single patient) as well as other components (e.g., components upstream of such a filter, including but not limited to inspiratory tubing and optional humidifier chambers).
[0555] With the advent of high-flow nasal cannula and its intended use in anesthesia settings via separate breathing circuits from those used for anesthesia, it is conceivable that breathing circuits will be reused. Breathing therapy circuits (such as those used during high-flow nasal cannula) are typically single-use items. One reason for this is to prevent contamination from one patient to another when using the same flow source and / or humidifier.
[0556] The following embodiments relate to other alternatives for preventing contamination and infection, allowing for the reuse of breathing circuits between patients during anesthesia. However, it should be noted that these ideas are not limited to anesthesia. It is conceivable that the embodiments described below can be used in general respiratory settings, such as CPAP therapy, to allow for the reuse of breathing circuits in any application.
[0557] In some embodiments, a filter may be used to prevent patient contamination of the breathing circuit. The filter may be a mechanical filter for capturing particles by direct interception. Alternatively, the filter may be electrostatic to capture particles by electrostatic attraction. In other alternatives, the filter may be hydrophobic, such that it repels water and does not promote microbial growth. The filter should allow air and water vapor (i.e., humidity) to pass through without compromising filtration of infectious material and condensate. In various instances, the filter media or filter media composition may comprise one or more of the following: mineral fibers, glass fibers, ceramic fibers, polypropylene, expanded polytetrafluoroethylene (PTFE), acrylic fibers including modified acrylic fibers and thermoplastic polyurethanes (e.g., Estane), cellulose fibers, or electrostatic fibers. Other filter media or media have been described in this specification, and specific properties or characteristics of these media or materials are repeated herein.
[0558] The filter can be located at the connection point between the patient interface (e.g., but not limited to a nasal cannula or nasal mask) and the breathing circuit. For example, the filter can be configured as a component for insertion into the end of a catheter that forms part of the breathing circuit, or as a component for insertion into the patient interface to be connected to the breathing circuit.
[0559] refer to Figures 22A to 22E The filter connector or component 1010 includes a filter or filter element 1012. Figures 22A to 22EIn this embodiment, component 1010 is a connector adapted to connect between the main tubing of the breathing circuit and the patient interface or patient interface conduit, having the same diameter as the main tubing. It should be understood that some embodiments may utilize an interface conduit with a smaller diameter than the main tubing. In other embodiments, the filter may be concentric with the main tubing and designed to have the same diameter as the main tubing and the interface or nasal cannula connections on each side. The filter, or the component including the filter or filter element, may even be substantially elongated to facilitate a design where the same filter media contact surface area becomes a substantially larger diameter.
[0560] Therefore, component 1010 may include a connector or socket, or a reducing connector or socket, or an adapter 1011 including filter 1012. The reducing connector, or socket, or adapter has one end with a first diameter (e.g., inlet) and the opposite end with a second diameter (outlet), wherein the first diameter is larger than the second diameter, or has the necessary diameter to operate with the component it must assemble with.
[0561] like Figure 22A As shown, filter 1012 may include a sock-bag type filter. Alternatively, such as Figure 22B As shown, filter 1012 may include a stacked disc filter. Furthermore, such as... Figure 22C As shown, filter 1012 may include a spiral filter. Furthermore, as... Figure 22D As shown, filter 1012 may include a pleated filter. In other alternatives, filter 1012 may include filter media blocks. In yet another alternative, such as... Figure 22E As shown, the filter 1012 may include a filter media disc 1012a having a filter media flow 1012b, the material flow being a fluid flow freely flowing in and out of the disc. The free-flowing material may vibrate at a high flow rate, aiding in filtration. The flow may contain small holes to capture particles.
[0562] For example Figures 22A to 22D As shown, the filter 1012 is equipped with a connector 1011 for connection between the patient interface and the catheter of the breathing circuit. The filter 1012 can be configured as a separate filter element to be inserted into or attached to the catheter and / or patient interface. For example, Figure 22E The filter can be inserted into the end of the catheter and / or the inlet of the patient interface, and the interface and the catheter are adapted to be assembled together for fluid communication, or can be integrated into the interface or as part of the interface arrangement itself.
[0563] In a further example, the patient interface tube (e.g., Figure 26AItem 1017) can be made of a perforated foam material with a sealed outer layer, making the interface tube breathable because it allows water vapor to pass through but not liquid water or large volumes of gas. In some embodiments, the patient interface is a nasal cannula comprising one or two nasal forks for fitting into a patient's nostrils. In such embodiments, each fork may provide a filter.
[0564] In some embodiments, the filter combined with the valve can be used to prevent patient contamination of the breathing circuit. For example, in some embodiments, the filter components may include a one-way valve 1013 and a filter attached to the outlet of the one-way valve. In some embodiments, the one-way valve may be a duckbill valve. Figure 23A and Figure 23B As shown, the expanded filter media can be attached to the duckbill end of the valve, such that when the valve is opened, the filter media expands to allow flow through the valve and the filter media and prevent contaminants from flowing back through the valve.
[0565] In some embodiments, disinfectants can be used to kill or remove infectious material from the breathing circuit, or alternatively, to reduce the level of infectious material to a safe level. In this specification and claims, the term "prevent" should be interpreted as having the equivalent meaning of "reducing to an acceptable level." Some examples of possible (liquid or gaseous) disinfectants include phthalaldehyde, glutaraldehyde, hydrogen peroxide, and nitrogen dioxide.
[0566] In some embodiments, disinfectant can be dispensed into the breathing circuit via a disinfectant reservoir, which releases disinfectant when the circuit is no longer in use on the patient. For example, as... Figure 24A and Figure 24B As shown, a disinfection sac 1014 can be provided to cover the end of the breathing circuit 10100. The sac may have a button 1015 for releasing disinfectant. Figure 24A The reservoir 1014 may be built into the breathing circuit or may be a separate component inserted by the user into the end of the breathing circuit, as shown. In some embodiments, the reservoir may be disposed in the wall of the connector of the breathing circuit or the conduit of the breathing circuit and may be released into the breathing circuit via a release mechanism through a one-way valve. The release mechanism may be actuated by an electrical signal generated when the patient interface is removed from the circuit. In some embodiments, a rinsing and disinfection unit may be attached to each end of the breathing circuit. The disinfection unit may alternately rinse the breathing circuit with water or disinfectant. The rinsing and disinfection unit may be a separate unit or may be built into the humidifier.
[0567] In some embodiments, the breathing circuit can be sterilized by providing radiation (e.g., ultraviolet or near-infrared ultrashort pulse laser) to the breathing circuit to inactivate microorganisms. Figure 25A As shown, in some embodiments, sheet radiation 1020 may be emitted at the connection point between the breathing circuit and the patient interface. For example, in some embodiments, the radiation source may be embedded in a connector 10100 at the end of the conduit of the breathing circuit. In some embodiments, the radiation may be provided as a separate radiation beam embedded throughout the circuit, or as beam and / or sheet radiation emitted throughout the circuit. In some embodiments, the radiation is continuously delivered to the breathing circuit, including during patient use of the circuit. In some embodiments, radiation is emitted to the breathing circuit only when the patient interface is disconnected. In some embodiments, the radiation source may be embedded in a humidifier or other hardware of a respiratory system upstream of the breathing circuit, which is connected to the end of the breathing circuit.
[0568] In some embodiments, heat sterilization can be used to kill microorganisms in the breathing circuit. For example, in some embodiments, the conduit of the breathing circuit may include a heating wire or heating element to prevent 'rain' or condensation from forming in the conduit. In some configurations, a heating element, such as a wire, may be positioned within the gas flow within the conduit. For example, the heating element may lie horizontally through the lumen of the conduit, or it may be placed on or fixed to the inner wall surface of the conduit. In some configurations, the heating element may be integrated into the wall of the conduit, or it may be wrapped around the outer surface of the conduit. The heating element may be co-molded in the wall of the conduit, or it may be clamped, glued, or otherwise held in a suitable position inside or outside the conduit. During a sterilization cycle, heat can be delivered to the breathing circuit to kill microorganisms by increasing the heat output of the heating element of the breathing circuit for a period of time between patients (with or without gas flow).
[0569] In some embodiments, disinfection units attached to the respective ends of the breathing circuit can be used, and these units disinfect by circulating hot water (e.g., at 90°C) and detergent through the breathing circuit. The disinfection units can be separate from or integrated with any other hardware (e.g., a humidifier) upstream of the breathing circuit. Alternatively, the disinfection units can be downstream of the breathing circuit. In some configurations, the disinfection unit can have a built-in gas source, such as a blower unit. In some embodiments, a heated collar can be provided at the connection point between the breathing circuit and the patient interface to prevent infectious material from migrating from the patient into the breathing circuit. In some embodiments, one or more of the filters and / or valves described above can be used in conjunction with the breathing circuit and disinfection units or disinfection methods described herein. In some embodiments, the connection for connecting the breathing circuit to the patient interface can also include a heating element to heat the connection, thereby disinfecting the connection point between the circuit and the patient interface.
[0570] In some configurations, the disinfection cycle can be initiated automatically or manually (e.g., by rinsing with disinfectant, radiation, and / or heating as described above). For example, the disinfection cycle can be initiated automatically by disconnecting the patient interface from the breathing circuit. Alternatively, the disinfection cycle can be activated on a timer sequence.
[0571] In some embodiments, an antimicrobial additive may be provided in the breathing circuit. For example, some possible additives include silver and silver-based additives (colloidal silver, silver salts, silver zeolite, nano-silver), siloxane additives, triclosan, and copper. The additive may be added to the breathing circuit, for example, by a collar around the end or connection point of the breathing circuit to which the patient interface is attached. The collar may be made of antimicrobial plastic. In some embodiments, the entire breathing circuit may be made of antimicrobial additives; for example, the breathing tube or catheter may be made of antimicrobial plastic. The antimicrobial additive may be integrated into the catheter as an additive in a polymer used to manufacture the catheter. In some embodiments, the release of the antimicrobial additive may be activated by using fresh water, other disinfectants, or by applying heat or humidity or UV light to the catheter containing the additive. The above disinfection methods can be used to release the antimicrobial additive in the catheter.
[0572] In some embodiments, the cap 1025 may be configured to cover the end of the breathing circuit, such as... Figure 26A and Figure 26B As shown, a cap can be provided at the connection point between the patient interface tube 1017 and the breathing circuit 10101, for example... Figure 26A As shown. In some embodiments, such as... Figure 26BAs shown, a suffix 1025 can be disposed between the patient interface 10200 and the breathing circuit at a connection point adjacent to the patient interface. In some embodiments, the suffix 1025 is a separate device that the user places on the end of the circuit when the patient interface is removed. In some embodiments, the suffix 1025 can be attached to the end of the breathing circuit, for example, by a cord. In some embodiments, the suffix is built into the breathing circuit and is activated by a signal (e.g., an electrical, mechanical, or magnetic signal) when the patient interface is removed or pulled out of the breathing circuit. In some embodiments, a pressure relief system or a throttling system may be included. For example, the suffix 1025 may include a pressure relief mechanism such as a pressure reducing valve to release excess pressure when the suffix is attached and if a gas or pressure source continues to pressurize the breathing circuit.
[0573] In this way, when the interface is not attached (i.e., when the interface is changed between patients), contaminants cannot enter or are prevented from entering the breathing circuit. When the flow is traveling in one direction (or mainly in one direction), contaminants from the interface cannot enter or are prevented from entering the circuit during use.
[0574] The cap may also optionally be made of filter media or may include a one-way valve. In this way, additional protection against contamination can be provided. For example, this may be particularly useful in situations where the gas flow to the patient interface is shut off but the interface is still on the patient; without the cap or filter, condensate or contaminants from the patient could potentially travel along the circuit.
[0575] Alternatively, the gas supply can be triggered by connecting / disconnecting the interface (i.e., the flow is always on or kept on (at least at a low level) when the interface is connected, and shut off once the interface is disconnected from the gas source).
[0576] In some embodiments, the breathing circuit may include an orifice to generate a rapid flow through the orifice, thereby preventing infectious material from traveling back into the breathing circuit against the flow direction through the orifice. This is related to the Peckley number (the ratio of convection rate to diffusion rate). If the Peckley number is greater than 1, convection dominates relative to diffusion, and infectious material will not be able to diffuse into the breathing tube through the orifice. Ideally, the higher the Peckley number (100, 1000, etc.), the less likely diffusion will affect infectious material, and the less likely infectious material will travel across the orifice into the breathing circuit.
[0577] In some embodiments, a one-way valve system may be provided that allows only unidirectional flow from the breathing circuit to the patient interface. The one-way valve allows the flow of breathing gases from the breathing circuit to the patient interface and the patient, but prevents flow back from the patient interface into the breathing circuit. The one-way valve prevents or reduces the entry of infectious substances from the patient interface into the breathing circuit. The patient interface can be discarded after use, and the breathing circuit can subsequently be used by another patient.
[0578] In some embodiments, the valve may be located at the connection point between the patient interface and the breathing circuit. For example, in some embodiments, the valve may be provided as a component for insertion into the end of a catheter forming part of the breathing circuit, or in some embodiments, the valve may be provided as a component for insertion into a patient interface to be connected to the breathing circuit.
[0579] In some embodiments, the valve may be disposed within a connector for connecting a patient interface to a breathing circuit. In some embodiments, the valve may be provided as a separate element to be inserted into or attached to a catheter and / or patient interface.
[0580] In some embodiments, the valve may be as follows: Figure 27A The duckbill valve 1031 shown is as follows: Figure 27B The umbrella valve 1032 shown is as follows: Figure 27C The check ball valve 1033 shown is a constant speed valve.
[0581] In some embodiments, the valve can be triggered by inhalation. This means that flow is delivered only during inhalation when pressure allows the valve to open. During exhalation, the valve closes, and flow is not allowed to return to the breathing circuit.
[0582] In some embodiments, the breathing circuit may include a pressure relief system to ensure that the breathing circuit is not overpressurized.
[0583] In some embodiments, the flow source that provides the breathing gas flow to the breathing circuit or other hardware of the breathing system upstream of the breathing circuit includes a toggle switch that allows the flow to be adjusted to an ON mode (e.g., up to 70 L / min or some other high flow rate or pressure associated with a high flow rate) and an OFF mode (e.g., up to 10 L / min or some other low flow rate or pressure associated with a low flow rate).
[0584] When the system is off, a low-speed flow still exists from the flow source to the patient interface, and therefore, the reverse flow and transfer of infectious material back into the breathing circuit is not possible. For example, in some embodiments, upstream device articles such as flow sources in the breathing circuit include electrical connections that allow / initiate OFF flow when the flow source is connected to the breathing circuit and allow / initiate ON flow when the breathing circuit is connected to the patient interface. In some embodiments, upstream device articles such as flow sources in the breathing circuit include mechanical toggle switches (e.g., push valves) that allow orifice openings of different sizes to be introduced into the flow path to control the flow.
[0585] In some embodiments, a hydrophobic screen may be provided at the connection point between the patient interface and the breathing circuit. For example, in some embodiments, the screen may be provided at the end of a conduit forming part of the breathing circuit, or in some embodiments, the screen may be provided at the patient interface to which the breathing circuit is to be connected. The hydrophobic screen may have a pore size determined to ensure sufficient supply pressure at 70 L / min (or some other target high flow rate) for flow through the pores of the screen from the breathing circuit to the patient interface, but where the expiratory pressure from the patient is too low for expiratory breathing to return from the patient interface to the breathing circuit through the screen.
[0586] Unless the context clearly requires otherwise, the words “comprising,” “including,” etc., used throughout this specification and claims shall be interpreted in a non-limiting sense (as opposed to an exclusionary or exhaustive sense), that is, meaning “including but not limited to.”
[0587] The intention is that references to the numerical ranges disclosed herein (e.g., 1 to 10) also combine references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and to any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore all subranges of all ranges explicitly disclosed herein are explicitly disclosed herein. These are merely examples specifically contemplated, and all possible combinations of values between the lowest and highest values are considered to be clearly indicated in a similar manner in this application.
[0588] The “(s)” following a noun used here refers to the plural and / or singular form of that noun.
[0589] As used herein, the term “and / or” means “and” or “or”, or in some cases the context allows for both.
[0590] Where the term “configure as” is used in this document, the term may be replaced by “arrange as” or “adapt as”.
[0591] In the above description, wherever reference has been made to an integral or component having a known equivalent, these integrals are incorporated herein as if they were presented individually.
[0592] The invention can also be generally regarded as existing in any or all combinations of the components, elements and features individually or collectively mentioned or indicated in the specification of this application, and two or more of the components, elements or features.
[0593] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge in the relevant field in any country of the world.
[0594] Certain features, aspects, and advantages of some configurations of this disclosure have been described with reference to the use of the gas humidification system with a respiratory therapy system. However, certain features, aspects, and advantages of the described gas humidification system can be advantageously used with other therapeutic or non-therapeutic systems that require gas humidification. Certain features, aspects, and advantages of the methods and apparatus disclosed herein can be equally applied to use with other systems.
[0595] Although this disclosure has been described with reference to specific embodiments, other embodiments that will be apparent to those skilled in the art are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, different components may be repositioned as needed. Features of any configuration described above may be combined with each other and / or the respiratory support system or humidifier may include one or more of the above configurations. Furthermore, implementing this disclosure does not necessarily require all features, aspects, and advantages. Therefore, the scope of this disclosure should be defined only by the appended claims.
Claims
1. A filter for use in a respiratory support system for delivering humidified gases to a user or patient at high flow rates, the filter comprising: A filter housing comprising a gas inlet port and a gas outlet port, wherein at least one of the gas inlet port and gas outlet port comprises an adapter insert comprising at least one pair of male connection fingers, the adapter insert configured to be located in the gas inlet port and / or gas outlet port such that the at least one pair of male connection fingers extends outwardly from the gas inlet port and / or gas outlet port, wherein the adapter insert is configured to facilitate connection with a connector located at a terminal end of a conduit via the at least one pair of male connection fingers, wherein the adapter insert comprises one or more retention members, each retention member substantially engageable with an inner surface portion of the filter housing.
2. The filter of claim 1, wherein, The male connection fingers comprise a notch or recess.
3. The filter of claim 2, wherein, The notch or recess is in an outer surface of the male connection finger.
4. The filter of claim 1, wherein, The male connection fingers extend only from the gas inlet port.
5. The filter of claim 1, wherein, The filter comprises a pleated panel filter.
6. The filter of claim 1, wherein, The filter or filter material of the filter comprises a hydrophobic characteristic or property.
7. The filter of claim 1, wherein, The adapter insert comprises a plurality of retention members, the plurality of retention members forming an array.
8. The filter of claim 1, wherein, Each retention member is configured for engagement with an inner surface of the filter housing.
9. The filter of claim 1, wherein, Each retention member is configured to resist axial displacement of the adapter in a direction towards an outer end of the port.
10. The filter of claim 1, wherein, Each retention member comprises at least a hook or other surface protrusion to engage or lock with the inner surface of the filter housing.
11. The filter of claim 1, wherein, The adapter insert comprises at least four retention members.
12. The filter of claim 1, wherein, The adapter insert comprises a first end portion from which the male connection fingers extend, a second end portion from which the one or more retention members extend, and a shank portion connecting the first end portion and the second end portion.
13. The filter of claim 12, wherein, The shank portion comprises a lumen or gas flow path for gas flow communication between each of the first end portion and the second end portion.
14. The filter of claim 12, wherein, The adapter insert comprises at least a first sealing member disposed about the shank portion and at least a second sealing member substantially disposed at or adjacent the first end portion of the adapter insert.
15. The filter of claim 14, wherein, The second sealing member provides a second sealing surface for surface sealing against a connector located at a terminal end of a conduit.
16. The filter of claim 14, wherein, Either or both of the first sealing member and the second sealing member is an O-ring.
17. The filter of claim 14, wherein, The first sealing member is disposed about a circumference of the shank portion.
18. The filter of claim 14, wherein, The first sealing member is configured to provide a first sealing surface extending radially outwardly from the shank portion.
19. The filter of claim 14, wherein, The first sealing member is configured to provide a first sealing surface for sealing with an inner surface of the port of the filter housing.
20. The filter of claim 14, wherein, The first sealing member is intermediate the first end portion and the second end portion of the adapter insert.
21. The filter of claim 14, wherein, The second sealing member is substantially disposed at or adjacent the first end portion of the adapter insert.
22. The filter of claim 14, wherein, The second sealing member is substantially at or adjacent a base of the male connection finger when the male connection finger extends out of the first end portion of the adapter insert.
23. The filter of claim 14, wherein, The first end of the adaptor insert includes a radially extending lug or lip.
24. The filter of claim 23, wherein, The second sealing member is located substantially on an upper side surface of the lug or lip.
25. The filter of claim 23, wherein, The lug or lip extends radially outwardly such that its outer diameter is equal to or less than an outer diameter of the port in which the adaptor insert is to be located.
26. The filter of claim 23, wherein, The lug or lip extends radially outwardly such that its outer diameter is greater than an inner diameter of the port in which the adaptor insert is to be located.
27. The filter of claim 23, wherein, A lower side surface of the lug or lip contacts a terminal face of the port in which the adaptor insert is to be located.
28. The filter of claim 23, wherein, A distance between the lower side surface of the lug or lip and the retaining member matches or is substantially equal to a length of the port in which the adaptor insert is to be positioned from the adaptor insert.
29. The filter of claim 23, wherein, The lug or lip is inserted or sandwiched between the end of the shank and the first end of the adaptor insert.
30. The filter of claim 23, wherein, The lug or lip is sandwiched between the base of the male connection finger and the end of the shank.
31. The filter of claim 14, wherein, The second sealing member is sandwiched between the base of the male connection finger and the end of the shank.
32. The filter of claim 23, wherein, The second sealing member is sandwiched between the base of the male connection finger and the upper side surface of the lug or lip.
33. The filter of claim 12, wherein, One or more splines or ribs are positioned around the shank, the one or more splines or ribs extending longitudinally along the shank.
34. The filter of claim 33, wherein, The one or more splines or ribs extend radially outwardly from the shank by a radial distance so as to at least partially engage or make surface contact with an inner surface of the port in which the adaptor insert is to be positioned.
35. The filter of claim 33, wherein, One or each of the one or more splines or ribs is configured to provide reinforcement or structural support to a wall of the port in which the adaptor insert is to be positioned.
36. The filter of claim 13, wherein, The lumen or gas flow path transitions from a substantially wider bore or larger inner diameter at the second end of the adaptor insert to a substantially narrower bore or smaller inner diameter at the first end of the adaptor insert.
37. The filter of claim 36, wherein, The lumen or gas flow path transition includes a substantially gradual or substantially linear change between different bore or inner diameters between the ends of the first end and the second end.
38. A kit for use in a respiratory support system for delivering humidified gas to a user or patient at a high flow rate, the kit comprising components to be changed between patients using the respiratory support system, the kit comprising: a filter as claimed in claim 1 located downstream of a humidifier chamber for receiving humidified gas from the humidifier chamber, or configured to be located downstream of a humidifier chamber for receiving humidified gas from the humidifier chamber; and a patient interface for delivering humidified gas to a user or patient, wherein the patient interface is in pneumatic communication with, or configured to be placed in pneumatic communication with, the filter downstream of the filter, wherein a male connection finger of the filter provides a portion of complementary coupling features that enable coupling and decoupling of the filter from a setup in which the filter is in pneumatic communication with the patient interface. wherein a male connection finger of the filter provides a portion of complementary coupling features that enable coupling and decoupling of the filter from a setup in which the filter is in pneumatic communication with the patient interface.
39. The kit of claim 38, wherein, The filter is coupled to, or configured to be coupled to, the patient interface, and wherein the patient interface includes a patient interface gas tube, wherein a gas outlet port of the filter and the patient interface gas tube include complementary coupling features to enable the filter to be coupled to the patient interface to provide pneumatic communication between the filter and the patient interface gas tube, with the filter in series with a gas flow path through the patient interface gas tube.
40. The kit of claim 39, wherein, The complementary coupling features are disconnectable from one another to enable the filter to be uncoupled from the patient interface gas tube of the patient interface.
41. The kit of claim 38, wherein, The patient interface is non-sealing.
42. A respiratory support system for delivering humidified gas to a user or patient at a high flow rate, the respiratory support system comprising: a gas source; a humidifier chamber in pneumatic communication with, or configured to be placed in pneumatic communication with, the gas source; an inhalation conduit in pneumatic communication with, or configured to be placed in pneumatic communication with, the humidifier chamber downstream of the humidifier chamber; a filter as claimed in claim 1 downstream of the humidifier chamber for receiving humidified gas from the humidifier, or configured to be downstream of the humidifier chamber for receiving humidified gas from the humidifier chamber; and a patient interface for delivering humidified gas to a user or patient, wherein the patient interface is in pneumatic communication with, or configured to be placed in pneumatic communication with, the filter downstream of the filter, wherein the male connection finger of the filter provides a portion of complementary coupling features that enable the filter to be coupled and uncoupled from an arrangement in which the filter is in pneumatic communication with the patient interface.
43. The respiratory support system of claim 42, wherein, The patient interface is non-sealing.
44. The respiratory support system of claim 43, wherein, The gas source supplies gas at a flow rate of up to about 150 LPM, or at a flow rate of between about 20 LPM and about 90 LPM, or at a flow rate of between about 40 LPM and about 70 LPM.
Citation Information
Patent Citations
Locking tube clip
WO2013073970A2
Improved latch assembly for satchel
CN2263904Y
Apparatus and method for humidification of inspired gases
US20050178381A1