Inhalation therapy device

Abstract

An inhalation therapy device comprising a housing body (4), a reservoir (2), a membrane unit (3) equipped with a membrane (5) and an actuator (6), and a flow path (7). Liquid is supplied to the first side of the membrane, and an aerosol is generated on the second side. During inhalation, a flow can be generated in a first flow direction from the second opening (9) to the first opening (8) of the flow path, and during exhalation, a flow can be generated in a second flow direction from the first opening to the second opening. The second opening is formed to establish a flow resistance of 160 Pa ± 100 Pa during the user's inhalation and to establish a flow resistance at least 25% lower than the flow resistance during inhalation during exhalation, and this flow resistance is measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time and exhalation time of 2 seconds each and a tidal volume of 500 ml.

Description

Technical Field

[0001] The present disclosure relates to an inhalation therapy device for entraining a generated aerosol and delivering it to a user or patient.

Background Art

[0002] Inhalation therapy devices, also known as (inhalation) nebulizers or aerosol delivery devices, are widely used to deliver a therapeutically effective amount of pharmaceuticals such as drugs and vaccines in the form of an aerosol through the respiratory system of a user. Inhalation therapy devices can also be used for diagnostic purposes using radioactive isotopes in pulmonary loading tests. For therapy, aerosol inhalation is a preferred source of administration for some pharmaceuticals that can be intended for the treatment of systemic or respiratory diseases.

[0003] To achieve the intended treatment, aerosol particles must deposit on specific sites in the airways of a user's body, such as the lungs. Different particle sizes tend to deposit in different parts of the respiratory system. In this field, it is generally known that particles having a MMAD (aerodynamic mass median diameter) of less than 5 μm or less than 4 μm and at least 1 μm are required to enable deposition on the intended sites of the respiratory system.

[0004] Therapeutic aerosols are generated using an inhalation therapy device and delivered to a desired location in a user's body, particularly their airways. For this purpose, a fluid or liquid to be aerosolized or atomized, i.e., a drug, medicine, vaccine, etc., is supplied to a fluid or liquid reservoir in the inhalation therapy device. To aerosolize or atomize the liquid in the reservoir, the inhalation therapy device may comprise, for example, a membrane unit.

[0005] Such a membrane unit comprises a membrane having a plurality of apertures and an actuator coupled directly or indirectly (via a support plate supporting the membrane) to the membrane for vibrating the membrane.

[0006] A fluid or liquid can come into contact with a first side of the membrane by gravity. When the membrane is vibrated, the fluid or liquid (i.e., drug) passes through the aperture from the first side of the membrane, and an aerosol is generated on the second side of the membrane opposite to the first side.

[0007] The aerosolized or atomized fluid or liquid, i.e., aerosol, within the inhalation therapy device is supplied to the user's respiratory system within the scope of inhalation therapy when the user inhales it through the inhalation therapy device. In other words, when the user applies suction force by breathing, particularly by inhaling, through the inhalation therapy device, the aerosol is at least partially transported (by suction force) from inside the inhalation therapy device into the user's airway.

[0008] An example of a conventional inhalation therapy device having such a configuration can be derived, for example, from Patent Document 1. The membrane unit of the disclosed inhalation therapy device comprises a cylindrical liquid reservoir container, one end of which is separated by a disc-shaped membrane. The liquid placed in the reservoir container is in contact with the side of the membrane facing the reservoir.

[0009] Patent Document 1 further discloses a film connected (welded) to a substrate (support plate) and a vibration generator, such as a piezoelectric crystal, that surrounds the film in the circumferential direction and is connected (bonded) to the substrate, thereby allowing the film to be vibrated by the vibration generator and an electric drive circuit.

[0010] As a result, the liquid applied to the first side of the membrane is carried through the vibrating membrane aperture to the second side of the membrane opposite to the first side and discharged into the chamber as an aerosol. The disclosed inhalation therapy device further embodies a mouthpiece or mask connected to the chamber outlet and having a discharge valve. As a result, when the user exhales, the discharge flow does not enter the chamber, or enters only to a very limited extent, and is rather discharged to the external environment of the device through the discharge valve.

[0011] The disclosed device continuously drives a piezoelectric crystal throughout a (single) treatment time (single dosing interval). During this time, substantially all of the liquid in the reservoir is aerosolized by the membrane. During the user's exhalation, the generated aerosol is temporarily stored in the chamber, forming an aerosol cloud (a large clump). This aerosol cloud is inhaled upon inhalation and delivered to the user's airway for treatment. Thus, the treatment time can be kept relatively short.

[0012] However, one potential drawback is that as the power output of the aerosol generator (membrane, piezoelectric crystal, drive circuit, etc.) increases, the amount of aerosol that accumulates on the inner walls of the device (especially inside the chamber) (known as so-called "rainout") also increases. This leads to increased loss of administerable aerosol / pharmaceutical.

[0013] In other conventional inhalation therapy devices, the piezoelectric crystal is driven only during inhalation and stopped during exhalation. These inhalation therapy devices are often called respiratory trigger devices or respiratory actuation devices. These inhalation therapy devices often have the problem of long treatment times, i.e., long duration of therapy (long dosing intervals), which can be cumbersome for the user and may result in poor user adherence, such as interruption or premature termination of treatment before the intended dose of fluid or liquid in the reservoir is atomized and delivered to the user's airway for treatment.

[0014] All of the conventional inhalation therapy devices described above are typically operated by the user simply inhaling through the device (the inhalation flow is generated through the device's pathway), and the device is removed from the user's mouth and / or nose during exhalation. While the user can exhale without resistance, data such as flow parameters in the device's pathway cannot be obtained during exhalation, making it impossible to adequately monitor the entire treatment. Furthermore, in the case of continuous operation, the generated aerosol is lost without providing any therapeutic effect to the user.

[0015] Furthermore, removing the inhalation device after each exhalation negatively impacts the user's "natural" breathing, i.e., a stable respiratory cycle. Therefore, there is still a need for a simple and effective inhalation therapy device that can shorten the total treatment / therapy time (shorter interval between single doses).

[0016] In some cases, a single dosing interval may include at least five respiratory cycles, which consist of five inhalations and five exhalations, using at least 0.25 mL of fluid or liquid. In other cases, a single dosing interval may include at least ten respiratory cycles, which consist of ten inhalations and ten exhalations, using at least 0.5 mL of fluid or liquid. [Prior art documents] [Patent Documents]

[0017] [Patent Document 1] German Patent No. 19953317 [Overview of the project] [Problems that the invention aims to solve]

[0018] Based on the above, the purpose of this disclosure is to establish an inhalation therapy device that improves the overall quality of drug delivery while keeping the total therapy time as short as possible. [Means for solving the problem]

[0019] This objective is addressed by the inhalation therapy device according to independent claim 1. Different embodiments are derived from the dependent claims. According to a first aspect of this disclosure, the inhalation therapy device comprises a housing body, a reservoir for holding liquid, a membrane unit, and a flow path.

[0020] The membrane unit is disposed within the housing body and includes a membrane. When the fluid or liquid (i.e., drug) aerosolized or atomized in the reservoir of the inhalation therapy device is held by the membrane, the liquid is disposed within the housing body so as to be supplied to the first side of the membrane.

[0021] The membrane unit also includes an actuator for vibrating the membrane, and the actuator is coupled directly or indirectly via a support plate that supports the membrane. To generate an aerosol, the membrane includes a plurality of apertures, and when the membrane vibrates, the liquid passes through the apertures and an aerosol is generated on the second side, which is opposite to the first side of the membrane.

[0022] The flow path itself is defined within the housing body and includes a first opening at one end leading to the outside (environment) of the housing body (inhalation therapy device), and a second opening at the other end leading to the outside of the housing body.

[0023] The membrane unit is disposed within the flow path between the first opening and the second opening. This configuration is not limited to the membrane unit being arranged in series with the flow path itself. For example, the membrane unit can also be disposed within a separate channel in fluid communication with the flow path so that the generated aerosol can similarly be transmitted to the flow path. An example of such a configuration is a T-shaped connection within the flow path. At the same time, it is also possible to directly / serially dispose the membrane unit within the flow path so as to be at least partially surrounded by the flow within the flow path. In other words, an envelope flow is generated around or at a part of the membrane.

[0024] Thus, when the user inhales at the first opening, a flow within the flow path can be generated at least in the first flow direction from the second opening to the first opening. Thereby, it becomes possible to entrain the aerosol generated on the second side of the membrane within the flow path and deliver it to the user or patient.

[0025] The "first opening" can be understood, for example, as a "mouthpiece", an inhalation mask or the like, or at least as a connection to an element through which the user can apply a suction force to the flow path of the inhalation therapy device.

[0026] Therefore, in order to establish the flow in the flow path in the first flow direction, air needs to enter the flow path from the second opening. Therefore, when inhalation by the user is performed at the first opening of the therapy device and the aerosol generated in the inhalation therapy device is entrained and delivered, the "second opening" functions at least as an "entrance" for air. During the inhalation phase, the second opening may also be referred to as the "entrance opening" in the first flow direction, and the first opening may also be referred to as the "exit opening" in the first flow direction.

[0027] From the above perspective, the first flow direction can be interpreted as the "inhalation direction" of the (air) flow through the inhalation therapy device. Also, when the user or patient exhales air from the user's airway into the flow path at the first opening, it is also possible to generate a flow in the flow path in the reverse second flow direction from the first opening to the second opening. Therefore, the second flow direction can be interpreted as the "exhalation direction" of the (air) flow through the inhalation therapy device. Therefore, in the exhalation phase, the second opening may also be referred to as the "exit opening", and the first opening may also be referred to as the "entrance opening".

[0028] Thereby, the inhalation therapy device can maintain contact with the user (e.g., their mouth, and thus the airway) during the entire therapy duration (treatment time) of a single dosing interval, and inhalation and exhalation can be performed through the air flow of the inhalation therapy device.

[0029] The second opening of the inhalation therapy device according to the first aspect is shaped to function as a flow restrictor. Therefore, the second opening is shaped such that the flow resistance during the user's inhalation is 160 Pa ± 100 Pa, and the flow resistance during exhalation is at least 25% lower than the flow resistance during inhalation. These flow resistances are measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time of 2 seconds and an exhalation time of 2 seconds each, and a tidal volume of 500 ml.

[0030] Preferably, the flow resistance during user inhalation, generated by the shape of the second opening, is in the range of 160 Pa ± 60 Pa. More preferably, the flow resistance during user inhalation, generated by the shape of the second opening, is in the range of 160 Pa ± 30 Pa.

[0031] Therefore, "inhalation flow resistance" can also be understood as the "inhalation resistance" (or "pressure loss") that the user must breathe against when inhaling through the inhalation therapy device. This can also be understood as the negative pressure inside the inhalation therapy device, established by the shape of the second opening of the flow path of the inhalation therapy device. Similarly, "exhalation flow resistance" can also be understood as "exhalation resistance."

[0032] Measuring the "peak airflow" of a breathing pattern is a standard method for evaluating the airflow of anesthesia and respiratory equipment, such as nebulizer systems and their components. Therefore, to establish comparative information between anesthesia and respiratory equipment, it is common practice to apply the aforementioned sinusoidal breathing pattern—with an inhalation time of 2 seconds, an exhalation time of 2 seconds, and a tidal volume of 500 ml—to such equipment. Details regarding the detection and measurement methods, necessary equipment, and experimental conditions for these peak airflow values ​​are reflected, for example, in DIN ISO 27427, a standard of the DIN Standardization Committee for Emergency Services and Hospitals.

[0033] This international standard is designed for "general-purpose" inhalation therapy devices and is based on adult test parameters to evaluate the suitability of each device for the intended use as published by the manufacturer, as well as safety and compatibility between the materials of the device's components and the fluids administered.

[0034] Flow resistance is essentially determined solely by the second opening, which acts as a flow limiter. This is because the entire cross-section within the flow path of the inhalation therapy device is usually significantly larger than the cross-section of the second opening, which acts as a flow limiter when the user inhales. Therefore, it is justifiable to assume that the second opening, which acts as a flow limiter, is responsible for almost 100% of the flow resistance, i.e., the total flow resistance within the inhalation therapy device. This is because the other cross-sections within the flow path of the inhalation therapy device are larger than the cross-section of the second opening, and their potential hydrodynamic effects are (generally) negligibly small.

[0035] Based on the aforementioned standard DIN ISO 27427, and on the fact that the remaining (flow) cross-section within the device other than the second opening (which functions as a flow limiter) is sufficiently large, and as a result the absolute dynamic pressure does not exceed the inhalation resistance, it is justified to consider the aforementioned "peak flow rate" during the application of a standard (experimental) sinusoidal breathing pattern (inhalation time and exhalation time of 2 seconds each, tidal volume of 500 ml) to the inhalation therapy device as the maximum absolute pressure value detected inside the inhalation therapy device during the application of the sinusoidal breathing pattern.

[0036] Therefore, this peak flow rate corresponds to a flow rate of 23.56 l / min through the inhalation therapy device, and the pressure value inside the inhalation therapy device, and thus the flow resistance, can be determined using a standard setting with a differential pressure sensor that has one sensor support (for static pressure measurement) placed inside the device and one sensor support (for reference pressure measurement) in the environment when the aforementioned breathing pattern is applied.

[0037] In this regard, conventional inhalation therapy devices can only achieve equivalent flow resistance in inhalation and exhalation, or require a more complex configuration with additional structural elements to shorten the single-dose interval. When the flow resistance in the inhalation and exhalation directions through an inhalation therapy device increases and is the same, inhalation is adversely affected by increased respiratory effort, accelerated fatigue, or dyspnea and a considerably shorter inhalation time, and exhalation is also adversely affected by an undesirable prolongation of exhalation time due to significant exhalation resistance.

[0038] Prolonged exhalation time and / or significant inhalation resistance often cause discomfort to the user due to the need to breathe against the resistance, while a very short inhalation time negatively impacts the therapeutic effect in the user's airway.

[0039] Accordingly, this disclosure proposes providing a second opening that functions as a flow limiter configured to establish the aforementioned flow resistance when the user inhales, thereby realizing an inhalation therapy device that can extend the inhalation time while keeping the discharge resistance low, and thereby keep the discharge time short by reducing the "discharge resistance".

[0040] By increasing the intake resistance while simultaneously decreasing the discharge resistance, four main advantages can be obtained: i) The maximum flow rate during inhalation is limited by increased respiratory resistance (caused by a second opening that acts as a flow limiter), resulting in improved drug deposition in the lungs. Therefore, the amount of drug deposited in the user's lungs increases, and the amount of medical compound that needs to be aerosolized for therapy can be reduced. As a result, the total therapy time can be shortened.

[0041] ii) By extending the inhalation duration, the (time) window for aerosol generation is lengthened, ultimately shortening the duration of therapy. iii) Increased respiratory resistance prolongs inhalation, while decreased respiratory resistance shortens exhalation. This allows the user to maintain respiratory rate and minute ventilation, thus reducing respiratory effort.

[0042] iiii) In the operation of the membrane unit (i.e., the atomizing unit), the inhalation pressure signal generally plays a more important role. The inventive shape of the second opening increases the absolute pressure during inhalation, which facilitates triggering and improves the therapy, particularly in terms of increased reliability and a shorter duration of therapy.

[0043] In other words, the extended inhalation time caused by the aforementioned range of inhalation resistance is advantageous for the success of therapy. This is because the user's inhalation through the inhaler becomes longer and more gradual (in terms of flow rate), allowing the aerosolized liquid (i.e., the drug) to be delivered to the user's airways in an improved manner. This allows for an increase in the dosage (per inhalation and per inhalation therapy).

[0044] This inhalation therapy device can also be held continuously in the user's mouth and / or nose during therapy (a single dosing interval), and both inhalation and exhalation are performed through the pathway of the inhalation therapy device.

[0045] Furthermore, it cannot be ignored that placing a flow limiter directly at the opening of the flow path, in this case the second opening, improves the cleanability and disinfection of the inhalation therapy device. This is because placing the flow limiter between the first and second openings could increase contamination in the resulting undercut. This is because such a flow limiter hydrodynamically and, naturally, geometrically separates one large cavity into two smaller cavities, inducing the undercut.

[0046] According to a second embodiment, the inhalation therapy device further comprises a sensor. The sensor includes a measurement port located in the flow path. The sensor is configured to detect flow parameters of the flow in the flow path via the measurement port.

[0047] In a preferred configuration, the “flow parameter” to be detected or measured is a pressure value, volumetric flow rate, or something similar. All of these flow parameters can be used to trigger aerosol generation within the flow path of the inhalation therapy device via the membrane unit.

[0048] By placing the measurement port within the flow path, it becomes possible to accurately evaluate at least the quality of inhalation, which allows for determinations such as whether inhalation is being performed for a sufficient duration or whether it should be extended. Similarly, evaluation is possible not only in the first flow direction but also in the second flow direction, i.e., the flow of the user's exhalation through the inhalation therapy device. This evaluation enables optimized operation of the membrane unit of the inhalation therapy device and / or so-called "beat triggering."

[0049] Preferably, the measurement port is located upstream of the membrane in the flow path when viewed in the first flow direction. In other words, when the inhalation therapy device is held by the user and / or used for inhalation therapy, the measurement port is located "rear" of the membrane unit. This improves measurement quality because it effectively prevents unwanted amounts of aerosol / fluid particles, sputum, and / or bacteria from the user from coming into contact with the measurement port.

[0050] According to the third embodiment, the flow path is shaped such that the entire flow rate that flows in the first direction toward the first opening during suction passes through the second opening. In this context, "flow rate along the first direction" is understood as the amount that the user inhales during inhalation through the inhalation therapy device, which then moves within the device and reaches the user's airway. However, for completeness, it should be noted that, due to the volume of the inhalation therapy device itself, not the entire amount that flows into the device through the second opening reaches the user's airway.

[0051] This reduces the structural complexity inside the housing because sub-channels and measurement paths can be omitted. Consequently, disinfection and / or cleaning of the device becomes easier.

[0052] According to the fourth embodiment, the second opening is located on the upstream side of the membrane unit when viewed in the first flow direction. In other words, when the inhalation therapy device is used for therapy, that is, when air is inhaled into the user's airway from the first opening of the flow path, the second opening can be understood as being located "rear" of the membrane unit. This makes it possible to position the second opening far away from the first opening, so that the first opening is located downstream of the membrane unit when viewed in the first flow direction. Therefore, air is guided from the "rear" of the membrane unit when viewed in the first flow direction through the flow path from the second opening, and this air passes through the membrane unit, for example by being guided to bypass the membrane unit, and merges with the aerosol generated by its flow around and / or in the area of ​​the second side of the membrane of the membrane unit, and is then guided through the flow path toward the first opening.

[0053] According to the fifth embodiment, the second opening is located in the upper half of the housing body when the inhalation therapy device is held by the user during therapy. The therapy is performed, for example, in the user's seated position with the user's head in an upright position.

[0054] This prevents the second opening through which air enters the flow path from being accidentally blocked by the user holding the inhalation device while the user is seated with their head upright during therapy. Thus, it can be ensured that flow parameters, such as the pressure value in the flow path, can be reliably detected during therapy. Conversely, it can be ensured that the second opening is always open and not accidentally blocked.

[0055] Preferably, the second opening is located not only in the upper half of the housing body, but also in an area 5 mm to 10 mm from the top of the housing body when the inhalation therapy device is held by a user who is sitting with their head upright during therapy.

[0056] Therefore, the risk of the second opening being accidentally blocked during therapy can be effectively reduced. This is because the second opening, located at the top of the housing body, is extremely unlikely to be blocked, for example, by the user's hand or fingers holding the inhalation therapy device.

[0057] In this context, the term "uppermost position" is understood to refer only to the housing itself. Therefore, additional structural elements of the inhalation therapy device, such as the lid covering the reservoir, are not considered.

[0058] Alternatively, when the inhalation therapy device is held by a user in a seated position with their head upright during therapy, the term “highest position” is interpreted to refer only to the flow path within the inhalation therapy device.

[0059] In a preferred embodiment, the inhalation therapy device may further include a gripping portion for allowing the user to comfortably hold the inhalation therapy device. This gripping portion may be reversibly detachable from the lower part of the housing body, in which case the lower part of the housing body can be understood as the atomizing portion. Thus, the second opening is positioned in the aerosolizing portion at a distance from the gripping portion, preferably at the furthest possible distance. This, too, prevents the second opening from being blocked, for example, by the user's hand or fingers, during therapy using the inhalation therapy device.

[0060] In yet another embodiment, the second opening may be formed as a divided channel into the housing body, i.e., the outer shell of the inhalation therapy device, to more reliably prevent it from being blocked by the user or the user's hand / finger during (inhalation) therapy with the inhalation therapy device. This divided channel may comprise ribs, partitions, or fins extending toward the housing body forming the outer shell of the device at the location of the second opening in the housing body.

[0061] According to the sixth embodiment, the cross-sectional shape of the second opening decreases gradually, preferably continuously, when viewed along the second flow direction from the first opening to the second opening. This is an exemplary shape of the second opening to achieve a desired inhalation flow resistance of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, and more preferably 160 Pa ± 30 Pa. This extends the inhalation time, resulting in improved application of the aerosolized fluid or aerosolized liquid (i.e., drug) to the user's airway.

[0062] As the cross-sectional area of ​​the second opening gradually, preferably continuously, decreases along the second flow direction, the air entering the flow path from the second opening during intake faces the narrowed cross-sectional shape and the projections (arres), i.e., sharp edges, at the outermost position of the second opening. This shape causes flow separation at the outermost position of the second opening, increasing flow resistance during intake due to the need for increased velocity. At the same time, the reduction in cross-sectional area along the second flow direction reduces discharge resistance due to the absence of sharp edges, and as a result avoids flow separation along the flow direction.

[0063] This facilitates exhalation through the inhalation therapy device, eliminating the need to expel air against significant resistance, thus improving user comfort. Consequently, inhalation time can be extended and exhalation time shortened, resulting in a higher duty cycle and a reduction in the overall therapy time.

[0064] The “gradually decreasing cross-sectional shape” along the first flow direction can be understood, for example, as a second conical opening on the outside of the housing body, where the cross-section is narrower on the inside than on the outside. However, this term is not limited to such shapes.

[0065] The second opening of the flow path may be configured as a separate structural element separating the inner flow path from the outer one within the housing body, or it may be molded as an integral part of the housing body. In either case, the outermost position of the second opening may protrude from the housing body or be offset inward to obtain a uniform outer shape of the housing body.

[0066] According to the seventh embodiment, the end of the second opening facing outward from the housing body has an oval, elliptical, polygonal, or circular cross-sectional shape. Preferably, the second opening has a curved outer shell at the rear, i.e., in the region of the second opening facing inward towards the inhalation therapy device.

[0067] As described above, this configuration is advantageous for achieving a desired inhalation flow resistance of at least 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, and more preferably 160 Pa ± 30 Pa, while establishing a form that conforms to the rest of the shape of the inhalation therapy device and a reduced discharge resistance.

[0068] According to the eighth aspect, the end of the second opening facing outward from the housing body has a V-shape. In other words, the second opening, which faces outward from the main housing, has a shape resembling a V-shaped nozzle.

[0069] The sawtooth pattern is well known, for example, in the aerospace (and wind energy) industry as a noise-reducing "sawtooth" pattern applied to the trailing edge of jet engine nozzles (or wind turbines). In aerospace turbines, for example, its sharp edges allow for smooth mixing of the hot air in the engine core and the cooling air passing through the engine fan, thereby reducing noise-generating turbulence.

[0070] Similarly, a similar V-shape, or sawtooth pattern, can be provided at the second opening of the flow path through the housing body of the inhalation therapy device. Specifically, it can be provided at the end of the second opening facing the housing body, reducing noise such as hissing or whistling sounds caused by the airflow. As a result, this V-shape reduces background noise during therapy, thereby improving the applicability of the inhalation therapy device of the present invention.

[0071] In a preferred embodiment, the V-shapes, preferably at least three V-shapes, more preferably six V-shapes, are evenly distributed on the circumference of the end of the second opening facing outward from the housing body.

[0072] According to the ninth aspect, an inhalation therapy device according to any of the first to seventh aspects may further include an elastic protective member positioned at the end of a second opening facing outward from the housing body. In this regard, the elastic protective member is shaped to maintain the second opening open even when the user inhales and / or exhales through the inhalation therapy device.

[0073] The elastic protective member may have sufficient elasticity to reliably prevent damage to the second opening and its sharp edges, which may protrude outside the flow path, in the event that the inhalation therapy device is accidentally dropped or subjected to other impacts or stresses.

[0074] At the same time, its elasticity is selected such that the elastic protective member cannot completely cover the second opening during inhalation / exhalation. That is, the elastic protective member is not understood as a duckbill valve or the like that can close the second opening when the user inhales from the first opening. Rather, the elastic protective member is shaped so that the second opening remains open at all times, i.e., even when the user inhales and / or exhales through the inhalation therapy device. As a result, the elastic protective member is a protective member for protecting the second opening from damage by external forces, and at the same time does not affect the achievable flow resistance established by the shape of the second opening itself.

[0075] However, in an alternative configuration, the deflection of the elastic protective member during suction (and discharge) may help achieve the desired flow resistance during suction (and discharge) by increasing or decreasing the cross-sectional area of ​​the end of the second opening directed outward from the housing body.

[0076] Specifically, the flexibility of the elastic protective member at the second opening can also help generate an inhalation resistance distinct from the exhalation resistance. During inhalation, the flexible member at the second opening bends inward, partially closing the second opening and increasing the inhalation resistance. During exhalation, the elastic protective member bends outward due to its flexibility, providing a wider space for the exhalation flow, which reduces the flow velocity at the second opening and consequently reduces the breathing resistance during exhalation. Therefore, this embodiment can be understood to function like a shut-off duckbill valve.

[0077] The elastic protective member can be formed from, for example, TPU (thermoplastic polyurethane). In a preferred configuration, the elastic protective member also has a V-shape. According to an alternative configuration of the ninth embodiment, an inhalation therapy device according to any of the first to seventh embodiments may further include a protective member positioned at the end of a second opening facing outward from the housing body. In this regard, the protective member is shaped such that the second opening remains open even when the user inhales and / or exhales through the inhalation therapy device, and the protective member is configured as a plurality of fins, ribs, or V-shapes.

[0078] With the above configuration, even if the inhalation therapy device is accidentally dropped or subjected to other impacts or stresses, the second opening and its sharp edges, which may protrude outside the flow path, can be effectively prevented from being damaged.

[0079] According to the tenth embodiment, the flow path is shaped such that, during suction, the entire flow rate along the first direction passes through the second opening, and during discharge, the entire flow rate along the second direction also passes through the second opening.

[0080] Therefore, the air to be used for therapy is fully introduced into the flow path toward the first opening in order to deliver the generated aerosol through the second opening, and simultaneously discharged from the inhalation therapy device through the second opening. Thus, the inhalation therapy device has only a single flow path "channel" through which the entire inhalation flow for therapy passes. Also in this regard, for completeness, it should be reiterated that, due to the volume of the inhalation therapy device itself, i.e., dead space, not all of the amount flowing into the inhalation therapy device from the second opening reaches the user's airway.

[0081] This eliminates the need for multiple channels to arrange various related elements, sensors, etc. In this regard, the second opening is molded as a fixed-shape passive valve. A "fixed-shape passive valve" is understood as a geometric structure that does not require the control and / or presence of any movable elements that need to be operated to introduce air into the flow path and to discharge it from the flow path when discharged.

[0082] The second opening, molded as a fixed-shape passive valve, is configured to generate a flow resistance in the first flow direction during suction that is at least 25%, preferably 50%, more preferably 75%, and most preferably 90% higher than the flow resistance in the second flow direction during discharge.

[0083] By increasing the intake (flow) resistance while simultaneously decreasing the discharge (flow) resistance, four main advantages can be obtained: i) The maximum flow rate during inhalation is limited by increased respiratory resistance caused by a second opening that acts as a flow limiter, resulting in improved drug deposition in the lungs. Therefore, the amount of drug deposited in the user's lungs increases, and the amount of medical compound that needs to be aerosolized for therapy can be reduced. As a result, the total therapy time can be shortened.

[0084] ii) By extending the inhalation duration, the (time) window for aerosol generation is lengthened, ultimately shortening the duration of therapy. iii) Increased respiratory resistance prolongs inhalation, while decreased respiratory resistance shortens exhalation. This allows the user to maintain respiratory rate and minute ventilation, thus reducing respiratory effort.

[0085] iiii) In the operation of the atomizing unit, the inhalation pressure signal generally plays a more important role. The inventive shape of the second opening increases the absolute pressure during inhalation, which facilitates the triggering of the membrane unit and improves the therapy, particularly in terms of increased reliability and a shorter duration of therapy.

[0086] As mentioned above, these flow resistance values ​​in the first and second flow directions are also measured at the peak flow rate of a (standard) sinusoidal breathing pattern with inhalation and exhalation times of 2 seconds each and a tidal volume of 500 ml.

[0087] This can be achieved, for example, by a shape that, during suction, reduces the effective cross-section of the second opening compared to the (effective) cross-sectional shape of the second opening in the discharge direction, resulting in a higher flow velocity in the suction direction and therefore requiring higher resistance to achieve a hysteresis effect. Conversely, in the discharge direction, substantially the entire cross-section of the second opening, molded as a fixed-shape passive valve, can be utilized, thereby enabling discharge at lower flow velocities, i.e., against less resistance.

[0088] The shape of the second opening, which causes a different intake resistance than the discharge resistance, can therefore also be understood as a "fluid diode." However, the shape is not limited to the above configuration. Conversely, the same effect can be obtained by using a shape in which the flow is guided to bypass obstacles (e.g., bends, deflections, and constrictions) during intake, and the flow can pass through relatively smoothly during discharge, i.e., the flow resistance is reduced in the discharge flow direction. One commonly known shape of a second opening that produces intake resistance different from discharge resistance may be a "Tesla valve".

[0089] Regardless of the chosen geometric shape, it is possible to create an inhalation therapy device in which the inhalation flow resistance is higher than the discharge flow resistance. This makes it possible to achieve the advantages mentioned above. According to the eleventh embodiment, the second opening is not limited to a single second opening having a flow path to the outside of the housing body.

[0090] According to the eleventh embodiment, the second opening of the inhalation therapy device according to the tenth embodiment is formed by a plurality of sub-openings, each molded as a fixed-shape passive valve. Each of the sub-openings provides an opening for a flow path leading to the outside of the housing body. Furthermore, these sub-openings are configured to together generate a flow resistance in the first flow direction during inhalation that is at least 25%, preferably 50%, more preferably 75%, and most preferably 90% higher than the flow resistance in the second flow direction during discharge.

[0091] By dividing the configuration of the second opening into multiple sub-openings, the risk of the second opening becoming completely blocked during therapy can be reduced, while increasing the flexibility to accommodate a flow limiter in the device. At the same time, by providing the second sub-openings, an inhalation flow resistance of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, and more preferably 160 Pa ± 30 Pa can be achieved, and a reduced discharge resistance, which has a beneficial effect on therapy time compared to the inhalation resistance, can be achieved as described above.

[0092] According to the twelfth aspect, the second opening of the inhalation therapy device according to the tenth or eleventh aspect is shaped such that the flow resistance during inhalation in the first flow direction is 25% to 500%, preferably 50% to 300%, and more preferably 75% to 200%, higher than the flow resistance during discharge in the second flow direction.

[0093] The intake flow resistance is maintained in the range of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, and more preferably 160 Pa ± 30 Pa, but the configuration and shape of this second opening result in a discharge resistance that is significantly lower than the intake resistance.

[0094] According to the 13th embodiment, the second opening of the inhalation therapy device according to any of the 10th to 12th embodiments is shaped such that the flow resistance during inhalation in the second flow direction does not exceed 135 Pa, preferably 100 Pa, and more preferably 80 Pa, when measured at the peak flow rate of a (standard) sinusoidal breathing pattern with an inhalation time and exhalation time of 2 seconds each and a tidal volume of 500 ml.

[0095] Experiments and fluid simulations demonstrate that, for the reasons stated above, the combination of the inhalation resistance and the discharge resistance up to 80 Pa is within a favorable range for entraining and delivering the generated aerosol to the user's airway.

[0096] Given that these inhalation and exhalation resistances can be achieved by the geometric shape of the second opening, which is molded as a fixed-shape passive valve, a particularly simple, compact, and efficient inhalation therapy device becomes possible.

[0097] According to the 14th embodiment, the inhalation therapy device according to any of the 10th to 13th embodiments further comprises an air filter device. Preferably, the air filter device is reversibly detachable from the housing body. This air filter device is configured to filter out harmful or toxic substances from the aerosol generated within the housing body via a membrane unit and delivered to the user's airway when the user exhales, thereby preventing the aerosol from leaking into the environment.

[0098] Therefore, the air filter device is shaped to cover the second opening, so that during intake, the entire flow rate along the first flow direction passes through the air filter device, and during discharge, the entire flow rate along the second flow direction similarly passes through the air filter device.

[0099] In an alternative embodiment, the air filter device may be positioned in the flow path upstream of the second opening when viewed in the second flow direction (i.e., the second opening may be positioned downstream of the filter).

[0100] Regardless of the selected configuration, the entire flow rate along the first and second directions passes through the second opening and the air filter. It should be noted in this scenario that the combined shapes of the air filter and the second opening increase the intake and discharge flow resistance. In other words, both the air filter and the second opening are important in determining the flow resistance in the intake and discharge directions.

[0101] However, in further embodiments, the resistance of the second opening during inhalation and exhalation may be adjusted to minimize additional breathing resistance due to the filter. According to the 15th aspect, the inhalation therapy device according to any of the first to 9 aspects further comprises a third opening that extends to the outside of the housing body, the third opening being located in the flow path between the first opening and the second opening.

[0102] A check valve is provided in this third opening, which is configured to restrict the flow through the first opening in the first flow direction and to allow the flow through the third opening in the second flow direction from the first opening to the second opening, thereby enabling at least partial, preferably substantially complete, discharge of air through the third opening.

[0103] Such an inhalation therapy device is configured such that during inhalation, a "check valve" in the third opening blocks the opening in the flow path, allowing the inhalation flow through the second opening. However, during exhalation through the inhalation therapy device, the check valve opens, reducing the resistance of the third opening and its check valve to expel air from the inhalation therapy device. Therefore, at least a large portion of the expelled air can be expelled through the freely opening check valve of the third opening. Thus, the "check valve" can be interpreted as equivalent to a "one-way valve," establishing hysteresis. During exhalation, the combined opening area of ​​the second and third openings increases, reducing the local flow velocity at the openings at a given volumetric flow rate, and consequently reducing the discharge resistance.

[0104] According to the sixteenth aspect, the third opening of the inhalation therapy device according to the fifteenth aspect is provided on the upstream side of the membrane unit of the flow path when viewed along the first flow direction. Therefore, the third opening and its check valve can be positioned sufficiently far from the user's mouth, or the first opening that comes into contact with the mouth and nose, thereby avoiding discomfort caused by the air discharged from the inhalation therapy device.

[0105] According to the 17th aspect, the inhalation therapy device according to the 15th or 16th aspect further comprises an air filter device, which is preferably reversibly detachable from the housing body. The air filter device is configured to filter out harmful substances from the aerosol. Furthermore, the air filter device is shaped to cover a third opening, preferably a second opening and a third opening, so that, as a result, during discharge, the flow in the second flow direction passes through the air filter device outside the housing body.

[0106] In an alternative embodiment, the air filter device may be positioned in the flow path upstream of the second and third openings when viewed in the second flow direction (i.e., the second and third openings may be positioned downstream of the filter).

[0107] With this configuration, the inhalation flow from the second opening to the first opening, i.e., the inhalation flow direction through the housing body for delivering the generated aerosol, does not need to pass through the air filter device. At the same time, by covering the third opening and its check valve with the air filter device, the main flow in the second direction can be filtered, thereby ensuring the safety of the environment during therapy. This prevents large amounts of toxic substances from being released into the environment from the inhalation therapy device.

[0108] Non-limiting examples of this disclosure are described below with reference to the drawings. [Brief explanation of the drawing]

[0109] [Figure 1]An embodiment of the inhalation therapy device according to this disclosure is shown in a perspective view. [Figure 2] Figure 1 shows a schematic cross-sectional view along the flow path of the inhalation therapy device. [Figure 3] An exemplary configuration of the second opening of the inhalation therapy device is shown. [Figure 4] Another exemplary configuration of the second opening of the inhalation therapy device is shown. [Figure 5] Another exemplary configuration of the second opening of the inhalation therapy device is shown. [Figure 6] This shows the inhalation flow to the second opening of the inhalation therapy device of the present invention. [Figure 7] This shows an inhalation therapy device and its discharge through a second opening. [Figure 8] An exemplary configuration of a second opening equipped with a protective member is shown. [Modes for carrying out the invention]

[0110] Hereinafter, preferred embodiments of the present disclosure will be described with reference to the accompanying drawings. The preferred embodiment refers to inhalation therapy device 1. Hereinafter, preferred embodiments of the inhalation therapy device 1 of this disclosure will be described with reference to Figures 1 and 2.

[0111] It should be understood that such inhalation therapy devices 1 are often also called "aerosol delivery devices" or "nebulizers" in relation to therapeutic applications that involve / through the user's respiratory system.

[0112] Figure 1 shows an exemplary perspective view of an inhalation therapy device 1 according to a currently preferred embodiment of the present disclosure. From this figure, it can be deduced that the overall shape of the inhalation therapy device 1 is divided into two main parts. The inhalation therapy device 1 comprises a holding part 16, which may also be called the "controller part," and an aerosolizing part 17, which may also be called the "nebulizer part" or "nebulization set." However, this disclosure is not limited to such a "divided" configuration. It may also be possible to form the holding part 16 and the aerosolizing part 17 as a single integrated element. The holding part 16 shown in Figure 1 is intended to ensure that the user can securely hold the inhalation therapy device 1 during (aerosol) therapy. The aerosolizing unit 17 itself is provided to aerosolize or atomize a fluid or liquid (i.e., a drug, pharmaceutical, active substance, radioactive substance, etc.) via a membrane unit 3 (which will be described in detail below with reference to Figure 2).

[0113] The holding portion 16 may be equipped with the most relevant, preferably all, electronic features necessary for operating the inhalation therapy device 1. This allows the aerosolizing unit 17 to be configured as a disposable product or a product used for a certain period (e.g., a certain number of therapy sessions, several weeks, several months). At the same time, the holding portion 16, equipped with all the relevant electrical and sensing elements for operating the inhalation therapy device 1 and monitoring the therapy process, can be considered a long-life element, which requires virtually no cleaning, especially disinfection, before each therapy session. For example, a damp cleaning tissue is sufficient for cleaning the holding portion 17.

[0114] To ensure proper cleaning of the aerosolization unit 17 and to allow easy access to the membrane unit 3 located inside the aerosolization unit 17, the exemplary embodiment shown in Figure 1 provides a latch 18. The latch 18 allows access to the inside of the inhalation therapy device 1, and in particular to the membrane unit 3 located inside the aerosolization unit 17 of the inhalation therapy device 1.

[0115] In a given technical field, such a membrane unit 3 is also known as a "head unit." Similarly, the aerosolizing unit 17 is known as a "nebset," which reflects the abbreviation of nebulization set.

[0116] A preferred embodiment shown in Figure 1 is an inhalation therapy device 1 through which the user inhales and exhales during therapy. That is, the inhalation therapy device 1 is brought into contact with the user's mouth, for example, via a mouthpiece, or into contact with the user's mouth and nose via a face mask, so that the user's normal inhalation and exhalation are performed through the inhalation therapy device 1. In other words, during aerosol therapy, the inhalation therapy device 1, in particular its first opening 8 (details to be described later), must not come off the user's mouth (mouthpiece) or mouth and nose (face mask).

[0117] The method for generating aerosols inside the inhalation therapy device 1 and the method by which the actual therapy is performed are described in detail with reference to Figure 2. Figure 2 shows a cross-sectional view along the flow path 7 through the inhalation therapy device 1, and in this regard, focuses on the (upper) aerosolizing unit 17 of the inhalation therapy device 1 in Figure 1. Thus, only the uppermost section of the holding part 16 is shown in Figure 2, at which point the inhalation therapy device 1 is held in an ideal position by the user during therapy, with the user in a seated position with their head upright.

[0118] The area surrounding the inhalation therapy device 1, particularly its aerosolization unit 17, is defined by the housing body 4. Hereafter, it will be understood that Figure 2 shows the orientation of the inhalation therapy device 1 as it is held in the ideal position by the user while the user is performing therapy in a standing or sitting position.

[0119] In this scenario, a reservoir 2 for holding a fluid or liquid (i.e., a drug) is provided in the upper section of the housing body 4. As is clear from Figure 1, the upper section of reservoir 2 is covered with a lid to prevent the fluid or liquid in reservoir 2 from spilling during therapy. However, in Figure 2, this lid is not shown for the sake of a simpler explanation.

[0120] Furthermore, Figure 2 indicates that a membrane unit 3 is also provided within the housing body 4. To generate a therapeutic aerosol, the membrane unit 3 comprises a membrane 5 and an actuator 6. In the cross-sectional view of Figure 2, the membrane 5 is positioned upright, i.e., vertically, within the housing body 4, thereby allowing the membrane 5 to come into contact with the fluid or liquid held in the reservoir 2. In other words, the reservoir 2 and the membrane 5 are positioned adjacent to each other, and when the reservoir 2 holds a fluid or liquid, the liquid can be supplied to the first side 5.1 of the membrane 5. This allows the fluid or liquid to be automatically, i.e., transported by gravity, to the membrane 5 of the membrane unit 3, generating a therapeutic aerosol for the user. This is achieved by positioning the membrane 5 at the lowest position of the reservoir 2 when the inhalation therapy device 1 is held by the user during therapy (see Figure 2).

[0121] The membrane 5 has multiple apertures, and the actuator 6 is coupled to the membrane 5, which in turn allows the membrane 5 to vibrate. This causes the liquid to pass through the apertures, and an aerosol is generated on the second side 5.2, which is located opposite the first side 5.1 of the membrane 5. That is, for example, during inhalation, an aerosol is generated in the left chamber of the membrane unit 3 in Figure 2 within the housing body 4.

[0122] The inhalation therapy device 1 is equipped with a flow path 7 to deliver the aerosol generated on the second side 5.2 of the membrane 5 inside the housing body 4 of the inhalation therapy device 1 to the user's airway. The flow path 7 has a first opening 8 at one end that leads to the outside of the housing body 4, and a second opening 9 at the other end that leads to the outside of the housing body 4. In the embodiment shown in Figure 2, the first opening 8 and the second opening 9 are located on opposite sides of the housing body 4 and may be formed as separate structural elements that form the ends of the flow path. However, this arrangement is not constrained, and for example, the position of the second opening 9 may be offset from the longitudinal axis passing through the first opening 8 of the flow path 7, and the first and second openings of the flow path 7 may be an integral part of the housing body (having the shape described in detail below).

[0123] As described above, the first opening 8 is designed to come into direct or indirect contact (e.g., via a mask) with the user's mouth or the user's airway via mouth and nose in order to enable inhalation and exhalation through the inhalation therapy device 1 during aerosol therapy.

[0124] Conversely, the second opening 9 allows air to flow into and out of the flow path 7. Thus, the flow path 7 and the first and second openings 8 and 9 to the outside of the housing body 4 allow a flow to be generated in the flow path 7 in at least a first flow direction A from the second opening 9 to the first opening 8 when the user inhales through the first opening 8.

[0125] The membrane unit 3 is positioned within the flow path 7, thereby being within the “flow” generated by the user’s respiration, particularly inhalation, and this positioning allows the membrane unit 3 to be at least partially surrounded by the flow passing through the flow path 7. For example, the membrane unit 3 may be positioned at the axial and circumferential center of the flow path 7, so that during therapy, while breathing through the inhalation therapy device 1, while the user inhales, preferably while exhaling, an enveloping covering flow can pass through the membrane unit 3 in the flow path 7.

[0126] In this regard, the flow described above in the first flow direction A from the second opening 9 to the first opening 8 can also be understood as an inhalation flow (see Figure 2). Since the user's exhalation is also performed through the inhalation therapy device 1, when the user exhales at the first opening 8, a second flow direction B can also be created in the flow path 7 from the first opening 8 to the second opening 9, which can be understood as an "exhalation flow".

[0127] Figure 2 shows the first flow direction A and the second flow direction B. In addition, the curved arrow in Figure 2 extending from the second opening 9 to the first opening 8 represents an exemplary airflow path 7 along the first flow direction A (i.e., intake flow).

[0128] The membrane unit 3 in the flow path 7 is positioned so as to be at least partially, preferably completely, surrounded by an air sheath-type airflow when the user inhales through the inhalation therapy device 1, and the aerosol generated on the second side of the membrane can merge with the air guided through the flow path 7 from the second opening 9 along the first flow direction A in the forward region of the second side 5.2 of the membrane 5, and thus can be "carried" to the first opening 8 to deliver the generated aerosol to the user's airway.

[0129] This is because the user's inhalation at the first opening 8 establishes the aforementioned "flow" through the suction force on the air in the flow path 7 and the air drawn into the flow path 7 through the second opening 9.

[0130] To evaluate the quality of inhalation therapy, it is necessary to observe how inhalation and exhalation occur through the inhalation therapy device 1. In this context, "good therapy" refers to therapy with a particularly low inhalation flow rate and a high tidal volume among other parameters. A low inhalation flow rate can be achieved by increasing the flow resistance during inhalation. However, raising the resistance during inhalation and exhalation above a certain level can cause discomfort, and even shortness of breath, to the user, which increases the likelihood of the user interrupting the inhalation therapy. This can be avoided by lowering the exhalation resistance and shortening the exhalation duration, thus maintaining the user's normal minute ventilation. This fact increases the ratio of inhalation to exhalation duration, improves the duty cycle in the operation of the membrane unit 3, and ultimately shortens the treatment time. This also improves the quality of the sensor signal during inhalation when using a pressure sensor, thus enabling accurate activation triggering of the membrane unit 3. Overall, the quality of therapy is improved as a result.

[0131] To date, preferred embodiments of the present disclosure have found easy-to-manufacture and disinfection solutions that enable limiting the inhalation flow rate without unpleasant resistance during therapy, resulting in beneficially shorter overall therapy times. To evaluate flow parameters at least during user inhalation, the inhalation therapy device 1 includes a sensor 10 configured to detect, for example, the pressure value in the flow path 7. Therefore, the sensor 10 includes a measurement port 11 located within the flow path 7. Thus, the sensor 10 can detect a pressure value via the measurement port 11 to evaluate the flow resistance of the inhalation flow within the flow path 7. As shown in Figure 2, providing the measurement port 11 allows the sensor 10 to be positioned away from the measurement port 11 within the flow path 7. As can be seen from the cross-sectional view in Figure 2, for example, the sensor 10 can be located in the holding portion 16, and the measurement port 11 can be located in the flow path 7 through the housing body 4 of the aerosolization unit 17. To enable detection of flow pressure, the measurement port 11 and the sensor 10 may be connected via a hose, for example, as shown in Figure 2. The pressure sensor 10 may be, for example, a differential pressure sensor that measures the static pressure in the flow path 7 and compares it to the ambient pressure, i.e., a reference pressure.

[0132] To achieve the desired success in aerosol therapy, the inventors have discovered that, particularly when the inhalation flow resistance inside the housing body 4 is 160 Pa ± 30 Pa, it provides sufficient resistance to the user's normal breathing pattern without burdening the user with excessive inhalation resistance that could lead to premature termination of therapy.

[0133] To establish the flow resistance during the user's inhalation, the second opening 9 has a shape that functions as a flow limiter. That is, the geometric shape of the second opening 9 acts as a "barrier" to the air drawn into the flow path 7 within the inhalation therapy device 1 when the user inhales through the first opening 8.

[0134] At the same time, the shape of the second opening 9 acts as a less intense "barrier" to the air expelled from the patient's airway during exhalation and entering the flow path 7. Therefore, a stronger inhalation resistance can be achieved compared to the exhalation resistance.

[0135] To accurately and relatively measure and determine the flow parameters within the housing body 4 and its flow path 7 during the user's inhalation, this flow measurement is performed via the aforementioned pressure sensor 10 at the peak flow rate of a sinusoidal breathing pattern with inhalation and exhalation times of 2 seconds each and a tidal volume of 500 ml. This is strictly defined in DIN ISO 27427.

[0136] In the exemplary embodiment shown in Figure 2, not only the measurement port 11 but also the second opening 9 of the flow path 7 is located upstream of the membrane unit 3 when viewed in the first flow direction A. In the embodiment shown in Figure 2, the entire flow rate along the first flow direction A up to the first opening 8 passes through the second opening 9, enters the flow path 7, goes past the measurement port 11 and the membrane unit 3, merges with the aerosol at the second side 5.2 of the membrane 5, and is then discharged from the inhalation therapy device 1 into the user's body at the first opening 8 of the flow path 7.

[0137] In the embodiment shown in Figure 2, even during discharge, the entire flow rate along the second flow direction B passes through the second opening 9. In this regard, as is clear from Figure 2, the second opening 9 is located in the upper half of the housing body 4.

[0138] The actual shape of the second opening 9, which can be considered as a flow limiter, will be described in more detail with reference to Figures 3-5. To achieve the aforementioned flow resistance through the shape of the second opening, it is necessary to establish a geometric shape that induces higher flow resistance in the intake flow direction than in the discharge flow direction. Typical intake flow resistance versus discharge flow resistance relationships established by the shape of the second opening are 125%, 150%, 175%, 200%, or 300% or 400%. In the most preferred embodiment, the intake flow resistance versus discharge flow resistance relationship established by the shape of the second opening is 200%. Thus, an intake resistance of 160 Pa can be established, while the discharge resistance is "only" 80 Pa.

[0139] To achieve this, the second opening 9 of the flow path is molded as a fixed-shape passive valve. The second opening 9 can be formed as an integral part of the housing body 4 or as a separate structural element connected to the housing body 4, and can form an outlet for the flow path 7 through the housing body 4 for delivering the aerosol generated during therapy to the user.

[0140] Figures 2, 3, 4, and 5 show that the cross-sectional shape of the second opening 9 decreases continuously along the second flow direction B. This continuously decreasing cross-sectional shape of the second opening 9 along the second flow direction B allows the flow resistance in the first flow direction A to be set higher than that in the second flow direction B, without requiring an active element such as an operating valve or similar. However, the aforementioned relationship between intake flow resistance and discharge flow resistance does not need to be established by a single second opening 9 within the housing body 4. The relationship between intake flow resistance and discharge flow resistance can also be achieved by a combination of multiple small openings forming the flow resistance of the second opening 9 described above. However, for the sake of simplicity, we will focus on embodiments having a single second opening 8, as shown in Figures 2-5.

[0141] The embodiments shown in Figures 2-5 share a cross-sectional shape that continuously decreases along the second direction B, but its shape is different, which can be most easily seen at the end 12 of the second opening 9 facing outward from the housing body 4.

[0142] Depending on the desired shape and appearance of the outside of the housing body 4, for example, the end 12 of the second opening 9 facing outwards from the housing body 4 can be formed into an oval or elliptical cross-sectional shape. This is shown in Figure 3.

[0143] At the same time, as is evident from, for example, Figure 4, it is also possible to give the end 12 of the second opening 9 a polygonal, in this case a rectangular cross-sectional shape, which similarly establishes the same desirable relationship between intake flow resistance and discharge flow resistance established by the shape of the second opening.

[0144] Therefore, as illustrated in Figure 5, it may also be possible to give the end portion 12 a circular cross-sectional shape. The desired suction flow resistance of 160 Pa ± 30 Pa in the flow path 7 within the housing body 4 can be established during user inhalation, for example, by continuously decreasing the cross-sectional shape of the second opening 9 along the second flow direction B, such that the inner diameter of the second opening 9 is approximately 6.6 mm, the radius of the illustrated bell mouth (which can also be understood as a suction bell mouth) is 6.5 mm, and the radius of the "horn" is 5 mm.

[0145] As is clear from Figure 5, regardless of its cross-sectional shape, the end 12 of the second opening 9 can be provided with a V-shape 13 that has a positive effect on noise propagation caused by inhalation (and exhalation) through the inhalation therapy device. These "sawtooth" patterns (also known as V-shapes 13) provided at the end 12 of the second opening 9 make it possible to eliminate undesirable acoustic side effects that occur during therapy using the inhalation therapy device.

[0146] To facilitate understanding of the shape of the second opening that enables it to function as a flow limiter, refer to Figures 6 and 7. These show exemplary shapes and streamlines of exemplary suction flow (Figure 6) and exemplary discharge flow (Figure 7) through the second opening 9 of the flow path. Since Figure 6 shows the suction flow, the arrows for the first flow direction A are highlighted with thick lines in Figure 6, while the arrows for the second flow direction B (not shown) are shown with dashed lines. Since Figure 7 shows the discharge flow, the arrows for the second flow direction B are highlighted with thick lines, while the arrows for the first flow direction A (not shown) are shown with dashed lines.

[0147] As is clear from FIG. 6, the air sucked into the flow path 7 through the second opening 9 functioning as a flow restrictor is guided toward the sharp edge, that is, the end 12 of the second opening 9 facing the outside of the housing body 4. This hydrodynamically sharp edge (i.e., that of the end 12) with respect to the outside of the housing body 4, regardless of its oval, polygonal, or for example circular cross-sectional shape, reduces the effective cross-sectional area of the suction flow as a result of flow separation. From FIG. 6, it can be seen that the air passes through the end 12 of the second opening in the first flow direction A only with the first flow diameter D1. This makes the velocity of the flow passing through the second opening 9 relatively high, and thus the flow resistance is also relatively high. Therefore, the flow resistance during the user's inhalation is realized by the shape of the second opening 9.

[0148] Referring to FIG. 7, it is clear that these flow-restricting effects generally do not occur in the discharge flow direction B. This is achieved because in the second flow direction B, the air flow does not encounter a sharp edge, and as a result, the entire cross-section of the second opening 9, particularly the end 12 of the second opening 9 with respect to the outside of the housing body 4, is made available for the air discharged to the outside during the user's exhalation because the second opening 9 is shaped accordingly. This is shown by the second flow diameter D2 in FIG. 7. It is clear that the first flow diameter D1 (suction flow diameter) shown in FIG. 6 is smaller (D1 < D2) than the second flow diameter (discharge flow diameter) at the end 12 of the second opening 9. Therefore, the flow velocity through the second opening 9 is relatively low, and thus the flow resistance is also relatively low. In summary, the fixed-shape passive valve utilizes the hysteresis effect between the two flow directions. Here, the flow resistance during inhalation should not exceed 135 Pa, preferably 80 Pa, when measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time and an exhalation time of 2 seconds each and a tidal volume of 500 ml. This is because, in combination with an increase in inhalation resistance, a resistance of 135 Pa does not cause discomfort during exhalation.

[0149] In addition to the various exemplary shapes of the second opening 9 shown in Figures 3, 4, and 5, Figure 8 shows another exemplary configuration of the second opening 9. In the embodiment shown in Figure 8, which can be combined with any of the shapes of the second opening 9 shown in Figures 3, 4, and 5, a protective member is additionally provided at the end 12 of the second opening 9. In the exemplary embodiment of the protective member in Figure 8, the protective member is embodied by a plurality of ribs surrounding the end 12 of the second opening 9. This makes it possible to protect the "sharp edge" of the second opening 9, which is exposed to the environment of the inhalation therapy device 1, from damage or mechanical stress.

[0150] In a more preferred configuration, the second opening 9 may be positioned within the housing body 4 such that its end 12 is flush with the outer circumferential surface of the housing body 4. This makes it possible to protect the end 12 of the second opening 9 from damage or mechanical stress.

[0151] All embodiments discussed with reference to Figures 2-8 are based on a scenario in which the entire flow rate of suction and discharge is guided through the second opening 9 of the flow path 7. However, in another embodiment, a third opening 14 to the outside of the housing body 4 may be provided in the flow path 7 between the first opening 8 and the second opening 9.

[0152] This is shown, for example, in Figure 1. The third opening 14 is located upstream of the membrane unit 3 when viewed in the first flow direction A. Furthermore, a check valve 15 is provided at the third opening 14, which is configured to restrict the flow through the third opening 14 in the first flow direction A. That is, the check valve 15 completely prohibits the flow through the third opening 14 of the flow path 7 during suction. However, the check valve 15 is also configured to allow the flow through the third opening 14 in the second flow direction B from the first opening 8 to the second opening 9 in order to enable partial discharge of air through the third opening 14.

[0153] Regardless of the presence or absence of the third opening 14, the inhalation therapy device 1 may, in another embodiment not shown, be equipped with an air filter device that is reversibly detachable from the housing body 4. The air filter device is configured to filter out harmful substances from the aerosol. If the third opening 14 is present, the air filter device is shaped to cover the third opening 14, its check valve 15, and the second opening 9, so that during discharge, the flow in the second flow direction B passes through the air filter device and flows to the outside of the housing body 4. Conversely, if the third opening 14 is absent and the flow path 7 extends only between the first opening 8 and the second opening 9, the air filter device is shaped to cover the second opening 9, which is the only opening in the flow path 7 that leads to the outside of the housing body 4, in addition to the first opening 8, so that during inhalation, the entire flow along the first flow direction A passes through the air filter device, and during discharge, the entire flow along the second flow direction B passes through the air filter device.

[0154] In yet another, not-shown embodiment, an elastic protective member may be provided at the end 12 of the second opening 9 facing outward from the housing body 4. This elastic protective member is intended to protect the aforementioned sharp edge of the end 12 of the second opening 9 and is shaped to maintain the second opening open even when the user inhales and / or exhales through the inhalation therapy device 1. [Explanation of Symbols]

[0155] 1. Inhalation therapy device 2 Reservoirs 3 Membrane Units 4 Housing body 5 membrane 5.1 First side of the membrane 5.2 The second side of the membrane 6 Actuators 7 channels 8. First opening 9. Second opening 10 sensors 11 measurement ports 12 End 13 Yamagata 14. The third opening 15. Check valve 16 Holding part 17 Aerosolized portion 18 Latch 19. Protective component (rib) A. First flow direction B Second flow direction D1 First flow diameter D2 Second flow diameter

Claims

1. Inhalation therapy device (1), Housing body (4) and A reservoir (2) for holding liquid, A membrane unit (3), A membrane (5) disposed within the housing body (4) and having a plurality of apertures, wherein the membrane (5) is arranged such that when liquid is held in the reservoir (2), the liquid is supplied to the first side (5.1) of the membrane (5), and An actuator (6) coupled to the membrane (5) for vibrating the membrane (5), wherein the liquid passes through the aperture and an aerosol is generated on the second side (5.2) of the membrane (5) opposite to the first side (5.1) of the membrane (5), It comprises a membrane unit (3) having the following The inhalation therapy device (1) further comprises a flow path (7) defined within the housing body (4), the flow path (7) having a first opening (8) at one end leading to the outside of the housing body (4) and a second opening (9) at the other end leading to the outside of the housing body (4), so that in order to deliver the generated aerosol, when the user inhales through the first opening (8), a flow can be generated in the flow path (7) in at least a first flow direction (A) from the second opening (9) to the first opening (8), and when the user exhales through the first opening (8) into the flow path (7), a flow can be generated in the flow path (7) in a second flow direction (B) from the first opening (8) to the second opening (9). In the inhalation therapy device (1), the membrane unit (3) is positioned within the flow path (7) between the first opening (8) and the second opening (9). The second opening (9) is shaped to function as a flow limiter configured to establish a flow resistance of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa, during the user's inhalation, and a flow resistance at exhalation that is at least 25% lower than the flow resistance during inhalation, the flow resistance being measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time of 2 seconds and an exhalation time of 2 seconds, and a tidal volume of 500 ml. An inhalation therapy device (1) characterized by the following features.

2. The inhalation therapy device (1) according to claim 1, further comprising a sensor (10) having a measurement port (11) disposed within the flow path (7), preferably located upstream of the membrane unit (3) when viewed in the first flow direction (A), wherein the sensor (10) is configured to detect flow parameters of the flow in the flow path (7) via the measurement port (11).

3. The inhalation therapy device (1) according to claim 1 or 2, wherein the flow path (7) is shaped such that, during inhalation, the entire flow rate along the first direction (A) leading to the first opening (8) passes through the second opening (9).

4. The inhalation therapy device (1) according to any one of claims 1 to 3, wherein the second opening (9) is located upstream of the membrane unit (3) when viewed in the first flow direction (A).

5. The inhalation therapy device (1) according to any one of claims 1 to 4, wherein when the inhalation therapy device (1) is held by a user in a seated position with their head upright during therapy, the second opening (9) is positioned in the upper half of the housing body (4).

6. Inhalation therapy device (1) according to any one of claims 1 to 5, wherein when viewed along the second flow direction (B) from the first opening (8) to the second opening (9), the cross-sectional shape of the second opening (9) gradually becomes smaller.

7. The inhalation therapy device (1) according to any one of claims 1 to 6, wherein the end (12) of the second opening (9) facing outward from the housing body (4) has an oval, polygonal, preferably rectangular, or circular cross-sectional shape.

8. The inhalation therapy device (1) according to any one of claims 1 to 7, wherein the end (12) of the second opening (9) facing outward from the housing body (4) is provided with a V-shape (13).

9. A protective member is positioned at the end (12) of the second opening (9) facing outward from the housing body (4), and the protective member is shaped such that the second opening (9) remains open even when the user inhales and / or exhales through the inhalation therapy device (1). The protective member is a plurality of ribs, fins, or V-shapes (13), Or, The protective member is an elastic protective member, and preferably the elastic protective member has a V-shape (13). An inhalation therapy device (1) according to any one of claims 1 to 7.

10. The flow path (7) is shaped such that, during suction, the entire flow rate along the first direction (A) passes through the second opening (9), and during discharge, the entire flow rate along the second direction (B) passes through the second opening (9). The inhalation therapy device (1) according to any one of claims 1 to 9, wherein the second opening (9) is molded as a fixed-shape passive valve configured to generate a flow resistance in the first flow direction (A) during inhalation that is at least 25%, preferably 50%, more preferably 75%, and most preferably 90% higher than the flow resistance in the second flow direction (B) during discharge, and the flow resistance is measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time and discharge time of 2 seconds each and a tidal volume of 500 ml.

11. The second opening (9) is formed by a plurality of sub-openings, each molded as a fixed-shape passive valve. The plurality of sub-openings are configured together to generate a flow resistance in the first flow direction (A) during inhalation that is at least 25%, preferably 50%, more preferably 75%, and most preferably 90% higher than the flow resistance in the second flow direction (B) during exhalation, and the flow resistance is measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time and exhalation time of 2 seconds each, and a tidal volume of 500 ml, according to claim 10, inhalation therapy device (1).

12. The inhalation therapy device (1) according to claim 10 or 11, wherein the second opening (9) is shaped such that the flow resistance in the first flow direction (A) during inhalation is 25% to 500%, preferably 50% to 300%, more preferably 75% to 200%, higher than the flow resistance in the second flow direction (B) during discharge.

13. The inhalation therapy device (1) according to any one of claims 10 to 12, wherein the second opening (9) is shaped such that the flow resistance in the second flow direction (B) during discharge does not exceed 135 Pa, preferably 100 Pa, more preferably 80 Pa, and the flow resistance is measured at the peak flow rate of a sinusoidal breathing pattern with an inhalation time and discharge time of 2 seconds each and a tidal volume of 500 ml.

14. The inhalation therapy device (1) further comprises an air filter device, and the air filter device is preferably reversibly detachable from the housing body (4). The air filter device is configured to filter and remove harmful substances from the aerosol, The inhalation therapy device (1) according to any one of claims 10 to 13, wherein the air filter device (1) is shaped to cover the second opening (9) such that the entire flow rate along the first flow direction (A) passes through the air filter device during inhalation, and the entire flow rate along the second flow direction (B) passes through the air filter device during discharge.

15. A third opening (14) to the outside of the housing body (4) is provided in the flow path (7) between the first opening (8) and the second opening (9). An inhalation therapy device (1) according to any one of claims 1 to 9, wherein a check valve (15) is provided in the third opening (14), and the check valve (15) is configured to restrict the flow through the third opening (14) in the first flow direction (A), and to allow the flow through the third opening (14) in the second flow direction (B) from the first opening (8) to the second opening (9), thereby enabling at least partial, preferably substantially complete, discharge of air through the third opening (14).

16. The inhalation therapy device (1) according to claim 15, wherein the third opening (14) is provided upstream of the membrane unit (3) in the flow path (7) when viewed along the first flow direction (A).

17. The inhalation therapy device (1) further comprises an air filter device, and the air filter device is preferably reversibly detachable from the housing body (4). The air filter device is configured to filter the aerosol, The inhalation therapy device (1) according to claim 15 or 16, wherein the air filter device is formed to cover the third opening (14), so that when discharged, the flow in the second flow direction (B) passes through the air filter device and is discharged to the outside of the housing body (4).

Images