Inhalation therapy device

Abstract

The present disclosure relates to an inhalation therapy device. The inhalation therapy device comprises a housing, an aerosol generator configured to generate an aerosol from a liquid, a space, a measurement passage of a sensor connecting the space and a pressure transmitting member. The space is defined in the housing and fluidically connected to a first opening outside the housing and a second opening outside the housing, wherein, when a patient inhales at the first opening, at least an inhalation flow from the second opening to the first opening can be generated for entraining and delivering the generated aerosol. The sensor is positioned outside the space and configured to detect a pressure in the space via the measurement passage. The pressure transmitting member is adapted to transmit the pressure in the space to the sensor, wherein the pressure transmitting member encloses the measurement passage and is impermeable to the liquid.

Description

Technical Field

[0001] This disclosure relates to an inhalation therapy device for entraining and delivering generated aerosols to a user or patient. Background Technology

[0002] Inhalation therapy devices, also known as (inhalation) nebulizers or aerosol delivery devices, are widely used to deliver therapeutically effective amounts of medicines, such as drugs and vaccines, to a user in aerosol form via the user's respiratory system. Inhalation therapy devices can also be used for diagnostic purposes, such as lung provocation tests using radioactive isotopes. For therapeutic purposes, aerosol inhalation is a preferred route of administration for some medicines, which may be intended to treat systemic or respiratory diseases.

[0003] To achieve the desired therapeutic effect, aerosol particles must be deposited in specific locations within the user's respiratory tract, such as the lungs. Particles of different sizes tend to deposit in different parts of the respiratory system. It is generally known in the art that particles with a MMAD (median mass aerodynamic diameter) of less than 5 μm or even less than 4 μm and at least 1 μm are required to allow for efficient deposition in the intended sites of the respiratory system.

[0004] Inhalation therapy devices generate aerosols for therapeutic purposes and deliver them to the desired location within the user's body, particularly their respiratory tract. For this purpose, a fluid, especially a liquid (i.e., a drug, medication, vaccine, etc.), to be aerosolized or nebulized is supplied to a reservoir for holding the fluid or liquid within the inhalation therapy device.

[0005] In order to aerosolize or nebulize the liquid in the reservoir, the inhalation therapy device may include, for example, an aerosol generator.

[0006] Such an aerosol generator may, for example, include a membrane unit comprising an aerosol generating membrane having a plurality of orifices and an actuator directly or indirectly connected to the aerosol generating membrane via a support plate supporting the aerosol generating membrane to cause the aerosol generating membrane to vibrate.

[0007] A fluid or liquid may come into contact with the first side of the aerosol-generating membrane by gravity. Alternatively or additionally, the fluid or liquid may come into contact with the first side of the aerosol-generating membrane by venting a closed, flexible container. The fluid or liquid (i.e., the agent) passes through an orifice from the first side, and when the aerosol-generating membrane is vibrated, an aerosol is generated at a second side of the aerosol-generating membrane opposite the first side.

[0008] Then, as the user inhales through the inhalation therapy device, within the inhalation therapy range, the aerosolized or nebulized fluid or liquid (i.e., aerosol) inside the inhalation therapy device is supplied to the user's respiratory system. This means that when the user breathes through the inhalation therapy device, especially when he or she applies suction while inhaling, the aerosol is at least partially delivered from inside the inhalation therapy device (by suction) to the user's airway.

[0009] Alternatively or additionally, when a user breathes using a respiratory support device such as CPAP (Continuous Positive Airway Pressure), BiPAP (Bilevel Positive Airway Pressure), a ventilator, or a mechanical ventilator, the aerosol inside the inhalation therapy device may be supplied to the user's respiratory system within the inhalation therapy range.

[0010] Examples of conventional inhalation therapy devices with this configuration can be derived, for example, from EP 1 227 856 B1, US 6,962,151 B1, or DE 199 53 317 C1. The membrane unit of such disclosed inhalation therapy devices includes, for example, a cylindrical liquid reservoir container defined at one end face by an aerosol-generating membrane having a disc shape. The liquid disposed in the reservoir contacts the reservoir-facing side of the aerosol-generating membrane.

[0011] For example, DE 199 53 317 C1 discloses an aerosol generating membrane connected (welded) to a substrate (support plate) and an oscillator, such as a piezoelectric crystal, which surrounds the aerosol generating membrane in a circular manner and is connected (glued) to the substrate; so that the aerosol generating membrane can be oscillated by means of the oscillator and an electric drive circuit.

[0012] Therefore, liquid applied to the aerosol-generating membrane on the first side of the aerosol-generating membrane is transported through orifices in the aerosol-generating membrane to the second side of the aerosol-generating membrane opposite to the first side, so as to be discharged as an aerosol into the chamber. The disclosed inhalation therapy device further includes a mouthpiece or a mask connected to the outlet of the chamber and having an exhalation valve. Thus, when the user exhales, the exhaled flow will not enter the chamber, or only to a limited extent, but will be discharged into the environment of the device through the exhalation valve.

[0013] The disclosed device continuously drives the piezoelectric crystal during the (single) treatment time (single application interval), wherein substantially all the liquid in the reservoir is aerosolized by an aerosol generation membrane. During the user's exhalation, the generated aerosol is temporarily stored in the chamber, forming an aerosol cloud, which is inhaled and delivered to the user's respiratory tract for treatment during inhalation. Therefore, the treatment time can be kept relatively short.

[0014] However, a potential drawback is that as the output rate of the aerosol generator (aerosol generating membrane, piezoelectric crystal, drive circuit, etc.) increases, the amount of aerosol deposited on the inner wall of the device (especially inside the chamber) also increases accordingly; this phenomenon is known as 'rainout'. This leads to an increase in the loss of applicable aerosols / pharmaceuticals.

[0015] Other conventionally known inhalation therapy devices only actuate the piezoelectric crystal during inhalation and stop actuating it during exhalation. These devices are often referred to as respiratory triggering devices or respiratory actuation devices. It has been found that such inhalation therapy devices often have the problem of long treatment durations (long dosing intervals), which can lead to user apathy and poor user compliance, for example, treatment being interrupted or prematurely terminated before the intended dose of fluid or liquid in the reservoir has been nebulized and delivered to the user's airway for treatment.

[0016] The aforementioned traditional inhalation therapy devices are typically operated by the user through inhalation only; that is, an inhalation flow is generated through the device's flow path, and the device is removed from the user's mouth and / or nose during exhalation. While both methods allow for unobstructed exhalation, they do not provide satisfactory monitoring of overall treatment because data such as flow parameters within the device's flow path cannot be obtained during exhalation. Furthermore, with continuous operation, the resulting aerosol loss provides no therapeutic benefit to the user.

[0017] In addition, removing the inhalation therapy device with each exhalation can negatively impact the user's natural breathing—that is, his or her steady breathing cycle.

[0018] Therefore, traditional systems face the need for effective inhalation therapy devices that can achieve short total treatment time (single application interval), while reducing condensation and / or loss of generated aerosols that have no therapeutic effect on the user, and allowing the user to rest during treatment, i.e., without any medical loss during the single application interval.

[0019] To achieve this, various control mechanisms have been proposed for aerosol generation within inhalation therapy devices. The actuation of the piezoelectric crystal generally ensures that the loss of the aerosolized fluid or liquid containing the drug can be minimized during activation (during inhalation) and deactivation (during exhalation). Turning aerosol generation on and off, i.e., triggering it at the correct time, is quite challenging.

[0020] On the one hand, aerosol generation must begin no later than the moment the user begins inhalation to avoid unnecessarily prolonging the treatment time. On the other hand, aerosol generation must cease early enough to prevent the generated aerosols from being expelled from the inhalation device and the user's upper respiratory tract without any therapeutic application when the user exhales through the inhalation device.

[0021] To achieve the same purpose, the applicant has considered a so-called "pre-open / pre-close" inhalation therapy device. In this device, aerosol generation begins before the user actually inhales, thereby generating a certain amount of aerosol before actual inhalation, which is similar to pre-inspiratory aerosol generation, similar to the aerosol clusters discussed above; and the actuation of the piezoelectric crystal stops before exhalation begins, i.e., pre-expiratory aerosol generation is stopped.

[0022] To achieve this, all non-continuously operating inhalation therapy devices need to precisely monitor the user's breathing pattern, at least in the inhalation direction, to fully control the actuation of the piezoelectric crystal and thus fully control aerosol generation.

[0023] Therefore, most conventional non-continuously operating inhalation therapy devices include sensors. These sensors observe the flow through the inhalation therapy device and are thus necessary for precisely triggering aerosol generation.

[0024] However, previous solutions faced degradation in sensor signal quality during single or multiple consecutive application intervals. This was due to sensor contamination, such as by dust, dirt, germs, bacteria, viruses, moisture, fluids, sputum, and / or any other microorganisms, originating from the user's exhalation into the inhalation therapy device. This led to inaccurate sensor measurements, resulting in inhalation therapy device malfunctions and ultimately reduced treatment success rates, as well as an increased risk of microbial contamination of the inhalation therapy device, leading to increased cleaning workload. Summary of the Invention

[0025] In view of the above, one object of this disclosure is to provide an inhalation therapy device that improves the overall quality of drug delivery in a consistent and reliable manner.

[0026] This objective is achieved by means of an inhalation therapy device according to independent claim 1. Different embodiments can be derived from the dependent claims.

[0027] According to a first aspect of this disclosure, an inhalation therapy device includes a housing, an aerosol generator configured to generate an aerosol from a liquid, a space, a measurement passage, and a pressure transmission component.

[0028] The space is defined within a housing. The space is at least fluidly connected or communicated with a first opening and a second opening outside the housing, wherein when a patient inhales at the first opening, an inhalation flow from the second opening to the first opening can be generated to entrain and deliver the generated aerosol. Specifically, the space may be separate from, but fluidly connected to, a flow path. Alternatively, the space may form or be a flow path. The flow path may include a first opening at one end leading to the exterior of the housing (inhalation therapy device), i.e., the environment, and a second opening at the other end leading to the exterior of the housing (inhalation therapy device), i.e., the environment. Thus, when a patient inhales at the first opening, at least one inhalation flow from the second opening to the first opening can be generated in the flow path to entrain and deliver the generated aerosol.

[0029] Therefore, when a user inhales through the first opening, this flow from the second opening to the first opening can also be understood as the first flow direction, the inhalation flow direction, or simply the inhalation direction of the airflow (preferably a flow of air and aerosol) through the inhalation therapy device. Needless to say, the inhalation therapy device is not limited to operation solely by ambient air. The gas entering the flow path can be ambient air, 100% oxygen, or a mixture of oxygen and ambient air.

[0030] For example, the first opening can be understood as a mouthpiece, an inhalation mask, or at least a connection to such an element through which the user can apply suction to the flow path of the inhalation therapy device.

[0031] Alternatively, the device can also be used on ventilated patients, where the inhaled therapy device is connected to a respiratory support device, such as CPAP (Continuous Positive Airway Pressure), BiPAP (Bilevel Positive Airway Pressure), a ventilator, or a mechanical ventilator, to entrain and deliver the generated aerosol to the user's respiratory system.

[0032] Therefore, in order to establish the flow through the flow path in the first flow direction (i.e., the inhalation flow direction), air must thus be able to enter the flow path at the second opening. Therefore, when the user inhales through the first opening of the treatment device to entrain and deliver the aerosol generated inside the inhalation treatment device, the second opening at least serves as an air inlet. During the inhalation phase, the second opening can therefore also be referred to as the "inlet opening," and the first opening can therefore also be referred to as the "outlet opening."

[0033] Similarly, when the user exhales through the first opening, a flow in the opposite second flow direction is generated in the flow path from the first opening to the second opening to expel air from the respiratory tract. Therefore, the second flow direction can be interpreted as the exhalation flow direction or simply as the direction of (air) flow through the inhalation therapy device. During the exhalation phase, the second opening can therefore also be referred to as the "outlet opening," and the first opening can therefore also be referred to as the "inlet opening."

[0034] This allows the inhalation therapy device to remain in contact with the user (e.g., in contact with his or her mouth, and thus with his or her airway) throughout the entire treatment duration (or therapeutic time) of a single application interval (one inhalation therapy application), and both inhalation and exhalation can be achieved through the flow path and the airflow through the inhalation therapy device.

[0035] The measurement path connects the space (or, if the space is a flow path, the flow path) and the sensor. In other words, the measurement path is configured to allow the sensor to be positioned outside the space (or flow path), i.e., away from the surface of the space (or flow path) confined within the housing.

[0036] The sensor is configured to detect pressure in the space (or flow path) via a measurement pathway. This pressure measurement via the space (or flow path) and the measurement pathway—that is, via the inhalation therapy device fluidly connected to the air path (flow path) or even in the space within the air path (flow path)—makes it particularly possible to generate information about flow, especially volumetric flow rate, inhaled volume and / or exhaled volume, and information about the optimal start and stop points for aerosol generation via the aerosol generator when the patient inhales (and exhales) at the first opening.

[0037] Furthermore, the pressure measurement, performed via a fluid connection of the inhalation therapy device to an air path (flow path) or even within the space of the air path (flow path), allows for the acquisition / generation / calculation of information regarding respiratory rate, minute volume, I / E ratio (inhalation / exhalation ratio), flow rate above a certain threshold, cumulative volume above a certain threshold, minimum and maximum flow rate, etc.

[0038] Therefore, the measurement path can also be understood as the (measurement) channel connecting the space (or flow path) and the sensor, and the arrangement of the sensor outside the space (or flow path) can also be interpreted as being arranged away from the space (or flow path) and / or not being directly located in the space (or flow path).

[0039] Therefore, dynamic pressure effects, which would otherwise negatively impact pressure measurements taken by sensors in the space (or flow path), can be reduced.

[0040] Sensors configured to detect pressure in a space (or flow path) are also referred to as pressure sensors in the given technical field.

[0041] The pressure transmission component of an inhalation therapy device is a structural element adapted / configured to transmit pressure in a space (or flow path) and measurement pathway to a sensor, which can be generated by the user's inhalation (and exhalation) through the inhalation therapy device.

[0042] In this respect, the pressure transmission component closes the measurement path. In particular, the pressure transmission component closes the measurement path leading to space (or flow path).

[0043] Therefore, the pressure transmission components are constructed using an impermeable liquid.

[0044] The aforementioned configuration, capable of / configured to transmit pressure, should be understood as such that its shape and form enable the transmission of aerosol / gas pressure through the inhalation therapy device and to the pressure sensor without causing drastic losses that would degrade and / or adulterate the pressure value detected by the sensor. In other words, pressure can be transmitted through the pressure transmission member, and the sensor “behind” the pressure transmission member can be protected from any kind of liquid because the pressure transmission member seals the measurement passage. The term “behind” in this respect should be understood as an arrangement away from the space (or flow path) through the housing of the inhalation therapy device. Thus, the pressure transmission member completely seals the measurement passage in a way that prevents liquid from penetrating, and therefore acts as a hygienic barrier between the space (or flow path) and the sensor. Accordingly, liquid cannot pass through the pressure transmission member arranged in the measurement passage or at the interconnection between the space (or flow path) and the measurement passage.

[0045] Accordingly, the key concept of this disclosure is to provide a sealing element (i.e., a component) in the measurement path between the space (or flow path) and the sensor, which is capable of transmitting the pressure generated by inhalation (and exhalation) through the flow path (or flow path) in the space, while being impermeable to (at least) liquid to protect the sensor, thereby improving and maintaining the quality of pressure detection. Simultaneously, it establishes hygienic protection for the user, enabling the inhalation therapy device to be cleaned and disinfected with liquid according to the instructions for use, thereby achieving constant pressure detection quality using the sensor at a high level of hygiene.

[0046] Therefore, while the pressure transmission component allows pressure in the space (or flow path) to be transmitted to the sensor, it also improves the measurement quality of the pressure sensor, thereby improving the control of the inhalation therapy device. This is especially true when the measuring surface of the pressure sensor can be protected from any liquids that would negatively affect the sensor's measurement, which would ultimately affect the control of the inhalation therapy device, i.e., aerosol generation via the aerosol generator. Furthermore, the interaction of the measurement pathways allows the sensor to be positioned externally, not directly in the space (or flow path) along with the pressure transmission component. This enables the reduction or avoidance of dynamic pressure effects on pressure detection and protects the pressure sensor from environmental influences such as aerosol droplets, aerosol particles, sputum, any fluid or liquid from the (fluid) reservoir, dust, dirt, impurities, contaminants, germs, bacteria, viruses, moisture, sputum, and / or other microbial contamination.

[0047] Therefore, the generated flow of the device, particularly the flow path and pressure detection, can be functionally decoupled, and thus, the overall quality of drug delivery can be increased in a consistent and reliable manner when using an inhalation therapy device. Furthermore, it increases the freedom of design, as the sensors can be arranged remotely from the interior space (or flow path) of the inhalation therapy device's housing.

[0048] Preferably, at least one surface of the pressure transmission member oriented away from the sensor (optionally the entire pressure transmission member) comprises hydrophobic properties. These hydrophobic properties allow for the avoidance of deposition of the contaminants listed above, and thereby achieve improved pressure detection quality over long periods of time.

[0049] In addition to hydrophobic properties, pressure transmission components may also include lipophobic properties or other properties that prevent the deposition of said contaminants. This can be achieved, for example, through coatings or surface structures.

[0050] Therefore, contamination of the pressure transmission components can be prevented, such as contamination caused by germs, bacteria, viruses, moisture, fluids, phlegm and / or other microbial contaminants, such as those originating from the user's exhalation into the inhalation therapy device or from the aspiration of ambient air into the inhalation therapy device, and thus prevents the adulteration of pressure detection quality.

[0051] According to another aspect of this disclosure, the housing includes an atomizer housing and a controller housing. The atomizer housing defines a space (and / or a flow path) and houses the aerosol generator. The atomizer housing is removable from the controller housing. The controller housing houses a controller configured to control the aerosol generator and a sensor.

[0052] A portion of the measurement pathway is formed in the nebulizer housing, and another portion is formed in the controller housing. In this respect, the corresponding portions of the measurement pathway are airtightly connected when the inhalation therapy device is in use to ensure that pressure is transmitted from the space (or flow path) through the entire measurement pathway to the sensor.

[0053] The pressure transmission component is a portion of the measurement passage within the closed controller housing or a portion of the measurement passage within the atomizer housing.

[0054] The ability to detach the atomizer housing from the controller housing facilitates cleaning, storage, and / or replacement of both the atomizer and controller housings, and / or facilitates the sterilization of all components. For example, all components contained within the atomizer housing, particularly the front and rear of the aerosol generator, can be thoroughly rinsed under running tap water. Furthermore, the atomizer housing can be sterilized using a heat sterilizer with an operating time of at least 6 minutes or by continuously applying boiling water for approximately 15 minutes.

[0055] While the nebulizer housing, which defines the space (and / or flow path), will be cleaned after each application interval or at least daily, the controller housing, which does not come into direct contact with actual aerosols or other contaminants during treatment, contains the main electrical components used to operate the inhalation therapy device and only needs to be cleaned and / or disinfected after several consecutive application intervals, for example, with a clean, lint-free, damp cloth. Thus, functional separation is achieved because the sensitive electronic components in the controller housing are arranged separately from the actual space (or flow path) and aerosol generation within the nebulizer housing.

[0056] When the nebulizer housing and controller housing are in a non-detached state, i.e., when they are interconnected and thus attached, these portions of the housing establish a sufficiently airtight connection. This connection allows pressure entering the space (or flow path) to be transmitted between the nebulizer housing and the controller housing, particularly between the measurement passage portions in the controller housing and the nebulizer housing, and via a pressure-transmitting diaphragm towards a sensor disposed in the controller housing. This is achieved due to the airtight connection between the controller housing and the nebulizer housing when using the inhalation therapy device. This can be achieved, for example, through a form-fit connection between the controller housing and the nebulizer housing in the attached state and / or through the support of sealing members such as O-rings, one or more sealing lips, etc.

[0057] Therefore, this arrangement defines the alignment of portions of the measurement pathway in the nebulizer housing and portions of the measurement pathway in the controller housing. That is, when the inhalation therapy device is in use, they have the same central axis at least at the contact area of ​​the measurement pathways in the nebulizer housing and the controller housing.

[0058] The portion of the controller housing that encloses the measurement pathway with the pressure transmission component allows the number of parts in the atomizer housing that need to be cleaned after each use (i.e., after each application interval) to be kept as low as possible, making cleaning and / or disinfection as easy as possible. Additionally, the controller housing with the pressure transmission component ensures that the sensor is protected from environmental conditions even when the atomizer housing is removed from the controller housing.

[0059] Conversely, by enclosing the portion of the measurement path within the atomizer housing by making the pressure transmission component close, any liquids, fluids, or other elements that could negatively affect sensor operation can be kept as far away as possible from the controller housing and thus from the sensor.

[0060] Preferably, in the use state of the inhalation therapy device, the position of the nebulizer housing relative to the controller housing is secured via interlocking fasteners. This may include magnets that provide interaction. The arrangement of the interlocking fasteners and / or interacting magnets allows for ensuring / secured airtight connection between portions of the measurement passage in the controller housing and portions of the measurement passage in the nebulizer housing during the use state of the inhalation therapy device.

[0061] Such interlocking fasteners can also be understood as mesh-like fastening members, which reliably ensure precise definition of the relative position of the nebulizer housing relative to the controller housing. This allows for the alignment of the central axis of portions of the measurement pathways formed in the nebulizer housing with the central axis of portions of the measurement pathways formed in the controller housing. Therefore, the flow of gas / air / aerosol through the flow paths and interconnected measurement pathways can be prevented from being negatively affected during treatment.

[0062] Preferably, the inhalation therapy device includes two pressure transmission components. One pressure transmission component encloses a portion of the measurement passage in the controller housing, while the other encloses a portion of the measurement passage in the nebulizer housing.

[0063] Having two such pressure transmission components allows the measurement path portions in the controller housing and the nebulizer housing to be enclosed relative to the environment, combining the aforementioned advantages: the arrangement at the nebulizer housing provides hygienic separation because the controller housing itself does not need to be cleaned in such detail, and it prevents water, droplets, phlegm, etc., from contacting the controller housing. The pressure transmission components in the measurement path portion of the controller housing still protect the sensor even when the nebulizer housing is removed from the controller housing.

[0064] In this regard, it should be understood that in a configuration including two pressure-transmitting components, both pressure-transmitting components can be configured as non-deflecting bodies (described later), both pressure-transmitting components can be configured as flexible pressure-transmitting membranes (described later), or one pressure-transmitting component can be configured as a non-deflecting body and the other pressure-transmitting membrane can be configured as a flexible pressure-transmitting membrane. In any of these combinations, it is also possible that one or both of the two pressure-transmitting components are replaced by a gel (described later). In other words, the configuration of the two pressure-transmitting components can be selected from non-deflecting body type, flexible pressure-transmitting membrane type, and gel type, respectively.

[0065] Preferably, the aerosol generator is positioned in the flow path between the first opening and the second opening. When viewed in the direction of the suction flow, the connection between the measuring passage and the flow path is positioned upstream of the aerosol generator in the flow path.

[0066] That is, when viewed in the direction of inhalation flow, the measurement path containing the sensor is arranged "behind" the aerosol generator positioned within the flow path. In other words, it is located in a particularly "dry" area within the housing of the inhalation therapy device. Therefore, the potential contact between the measurement path and, consequently, the pressure transmission components and any kind of liquid, sputum, aerosol droplets, condensate, etc., can be kept to a minimum. This improves the measurement quality of the pressure sensor and, consequently, improves the therapeutic outcome of the inhalation therapy device.

[0067] However, this disclosure is not limited to this configuration. When viewed in the direction of the suction flow, the connection between the measurement passage and the flow path can also be located downstream of the aerosol generator in the flow path.

[0068] Preferably, the housing includes a support surface for supporting the inhalation therapy device on a horizontal surface. That is, for example, a portion of the housing is shaped to reliably maintain the position of the inhalation therapy device when it is placed on the support surface. Pressure transmission members, or when two pressure transmission members are present, are arranged inclined to the support surface.

[0069] Therefore, preventing aerosol droplets from adhering to (one or more) pressure transmission components avoids degradation of sensor measurement quality when the inhalation therapy device is placed, for example, on a table.

[0070] In addition, it is possible that one or more pressure transmission components are arranged at an elevated position inside the inhalation therapy device to further reduce the risk of adhesion and improve the drainage of any germs, sputum and / or aerosol droplets.

[0071] According to another aspect of this disclosure, the pressure transmission component is configured as a non-deflection body.

[0072] The term "non-deflection" should be understood as the pressure-transmitting element being shaped and sized such that it does not oscillate, i.e., deflect, during normal inhalation (and exhalation) through the flow path of an inhalation therapy device, in order to transmit the resulting pressure to the sensor via a non-deflection body. Conversely, the non-deflection body is impermeable to liquids but permeable to gases, such as air, to transmit pressure in the space (or flow path) to the sensor without requiring deflection for any type of pressure transmission.

[0073] In other words, the non-deflecting body is a rigid element, such as a disc or plate, that protectively seals the measurement path toward the sensor but allows pressure to pass through the non-deflecting body itself. That is to say, it can also be understood as a filter material that enables pressure transmission but prevents any liquid from passing through the non-deflecting body.

[0074] All ranges disclosed in this application, regardless of whether they are attributes such as pressure range, diameter range, thickness range, etc., are to be interpreted as including their respective upper and lower thresholds.

[0075] In this regard, it is preferred that the thickness of the non-deflecting body ranges from 0.1 mm to 5 mm, more preferably from 0.5 mm to 3 mm, more preferably from 0.5 mm to 2.5 mm, and most preferably from 1 mm to 2 mm.

[0076] This thickness of the non-deflecting body allows the pressure generated by the inhalation and / or exhalation flow through the flow path to be transferred in an improved manner via the measurement pathway to a sensor located behind the non-deflecting body: on the one hand, it can prevent accidental damage to the pressure transmission components, for example, during cleaning of the inhalation therapy device, while on the other hand, the measurement quality can be kept as high as possible because the potential loss in pressure transmission through / via the non-deflecting body can be kept as small as possible.

[0077] To achieve the aforementioned effects and advantages, it is preferable that the non-deflection body is composed of a porous material, which can also be understood as a foam layer. This porous material may have a pore size in the range of 0.1 to 50 μm, preferably in the range of 2 to 40 μm, and more preferably in the range of 3 to 35 μm. Each of the porous material configurations may have an average pore size of approximately 10 μm.

[0078] Preferably, the non-deflecting body comprises a thickness of 1.5 mm and a pressure differential of 0.01 to 10 m under a pressure difference of 5 mbar. 3 / min / m 2 The gas permeability is preferably 0.1 to 10 m at a pressure difference of 5 mbar. 3 / min / m 2The gas permeability is preferably 0.4 to 4 m at a pressure difference of 5 mbar. 3 / min / m 2 Gas permeability.

[0079] An example of a material with such properties at a thickness of 1.5 mm is the porous material VYON 1.5M from W. KÖPP GmbH & Co. KG (hereinafter referred to as KÖPP for easier orientation), such that the non-deflection body is preferably composed of KÖPP's VYON 1.5M material.

[0080] Alternatively, the non-deflection body can also be constructed from KÖPP's VYON 1.5F material. In such a configuration, the non-deflection body comprises a thickness of 1.5 mm and a thickness of 14 m under a pressure differential of 2.5 mbar. 3 / min / m 2 The corresponding gas permeability, and / or at a pressure difference of 10 mbar at 43 m 3 / min / m 2 The corresponding gas permeability, and / or at a pressure difference of 20 mbar at 75 m 3 / min / m 2 The corresponding gas permeability. In this configuration, the non-deflecting substrate is composed of a porous material with a pore size ranging from 8-12 μm to 95-115 μm. More preferably, the pore size is within the above range, with an average pore size in the range of 31-45 μm.

[0081] The diameter of the non-deflecting body can range from 3 mm to 50 mm, preferably from 5 mm to 20 mm, more preferably from 8 mm to 12 mm, and most preferably 10 mm.

[0082] These diameters may suggest a circular shape for the pressure-transmitting membrane. However, the pressure-transmitting membrane of this disclosure is not limited to a circular shape. Rather, the corresponding surface area generated by the exemplary diameters is crucial for obtaining reliable and efficient pressure transmission through the non-deflecting body while ensuring adequate protection of the sensor. For completeness, it is noted that the surface area covered by such a diameter of the non-deflecting body can be readily expressed by π×r. 2 Or π × (d / 2) 2 calculate.

[0083] The non-deflection substrate can be made of suitable plastics such as HDPE (high-density polyethylene). The non-deflection substrate can be made of UHMWPE (ultra-high molecular weight PE), HDPE (high-density polyethylene), PTFE (polytetrafluoroethylene or "Teflon"), or PE (polyethylene). PTFE is known as a PFAS material. Such PFAS materials may be susceptible to future government regulation. In this case, any suitable PFAS alternative material can be used, such as PAN (polyacrylonitrile polymer), polypropylene, polyurethane dendritic polymers, and PEEK polymers.

[0084] It is also possible that the non-deflecting body is formed of different materials that can also act as filters to transmit pressure, but prevent the transmission of any liquid or fluid, while also being corrosion-resistant. Examples could be synthetic fibers, PE felt, metals, or other porous media.

[0085] This allows for simple cleaning without the risk of any bacteria adhering to the surfaces of pressure-transmitting components oriented toward the space (or flow path).

[0086] According to an alternative aspect of this disclosure, the pressure transmission member is not a non-deflecting body, but a flexible pressure transmission membrane that is impermeable to both liquids and gases, and is configured to transmit the pressure in the space (or flow path) to the sensor due to deflection of the pressure transmission membrane caused by pressure in the space (or flow path).

[0087] Therefore, a flexible pressure-transmitting membrane should be understood as a membrane configured to oscillate / deflect as air is inhaled (and exhaled) through a flow path, thus transmitting pressure in the space (or flow path) to the sensor, much like an eardrum or a deflecting body.

[0088] The configuration allows any liquid and gas to be moved away from the sensor, while the pressure is transferred consistently through the deflection membrane, which can therefore be understood as a diaphragm.

[0089] In such a configuration, it is particularly preferred that the diameter of the pressure transmission membrane ranges from 3 mm to 50 mm, more preferably from 5 mm to 20 mm, more preferably from 6 mm to 20 mm, and most preferably from 6 mm to 15 mm.

[0090] This allows for a large effective diameter to be achieved for transmitting the pressure generated in the space (or flow path) by the patient's inhalation / exhalation through the flow path and measurement pathway of the inhalation therapy device. Therefore, only a small deflection is required, and minimal damping loss can be achieved.

[0091] Preferably, the thickness of the pressure transmission membrane ranges from 0.1 mm to 2 mm, more preferably from 0.1 mm to 1 mm, more preferably from 0.2 mm to 1 mm, and most preferably from 0.3 mm to 0.5 mm.

[0092] This allows for the creation of a particularly thin membrane, sufficiently robust to withstand forces acting on the membrane during cleaning of the inhalation therapy device, for transmitting pressure generated in the space (or flow path) by the patient's inhalation / exhalation through the flow path and measurement pathway of the device. In other words, this thickness ensures reliable pressure transmission while minimizing the risk of the flexible pressure-transmitting membrane rupture.

[0093] Preferably, the pressure-transmitting membrane is made of an elastomer, optionally a thermoplastic elastomer, which is commonly abbreviated as TPE, latex, or silicone.

[0094] This allows for simple cleaning without the risk of any bacteria adhering to the surface of the pressure-transfer membrane oriented toward the space (or flow path). This is especially true when (T)PE or silicone membranes result in a smooth surface that is easy and reliably cleaned. Additionally, the cost of the pressure-transfer membrane can be kept as low as possible.

[0095] Appropriately, the volume between the pressure transmission membrane and the sensor is greater than 1 mm³, preferably greater than 5 mm³, and less than 1600 mm³, preferably less than 1000 mm³, and more preferably less than 800 mm³.

[0096] In other words, the pressure-transmitting membrane and the sensor are arranged at a distance, such that a volume is provided between the components. This distance should be understood as the length of the normal from the surface of the flexible pressure-transmitting membrane to the surface of the sensor located at the end of the measurement passage (i.e., behind the pressure-transmitting membrane when viewed from the space (or flow path) of the inhalation therapy device) / at the end of the measurement passage.

[0097] The presence of such a volume between the pressure-transmitting diaphragm and the sensor results in the decoupling of the sensor's measuring surface from the pressure-transmitting diaphragm itself, allowing the diaphragm to oscillate freely when actuated by pressure. In this respect, a small volume between the pressure-transmitting diaphragm and the sensor allows potential pressure transfer losses to be kept as low as possible. This is the case when the amount of gas, particularly air, filling the volume as a compressible medium is kept as low as possible. The smaller the locked volume, the smaller the volume change with changes in the pressure to be transferred, the smaller the deflection of the pressure-transmitting diaphragm, and therefore, the less the degradation of measurement quality.

[0098] Preferably, and in order to ensure minimal loss of pressure in the space (or flow path) and interconnected measurement pathways transmitted to the pressure sensor via the flexible pressure transmission membrane, the hardness of the pressure transmission membrane ranges from 10 to 100 Shore A.

[0099] Such low stiffness ensures that potential losses in pressure transmission from one side of the flexible pressure-transmitting membrane, positioned in the spatial orientation (or flow path), to the other side, where the sensor arrangement in the measurement passage of the flexible pressure-transmitting membrane is located, can be kept as low as possible. Therefore, reliable control of the inhalation therapy device and thus the therapy itself can be achieved.

[0100] According to another alternative aspect of this disclosure, the pressure transmission member is neither a non-deflecting body nor a flexible pressure transmission membrane, but is configured as a liquid and gas impermeable gel, which is configured to transmit pressure in the space (or flow path) to the sensor.

[0101] This configuration allows the sensor to be protected from any environmental contamination while transferring the pressure to be detected by the sensor in a consistent and reliable manner.

[0102] According to another alternative aspect of this disclosure, in the case of a pressure transmission member, the pressure transmission member may be a non-deflecting body or a flexible pressure transmission membrane, and a portion of the measurement path between the pressure transmission member and the sensor is filled, in particular substantially completely filled, with a liquid- and gas-impermeable gel. For example, the gel comprises a very high viscosity that is impermeable to liquids and gases.

[0103] In the case of two pressure transmission components, both pressure transmission components are composed of non-deflecting bodies, both pressure transmission components are composed of flexible pressure transmission membranes, or one pressure transmission component is composed of a non-deflecting body and the other pressure transmission component is composed of a flexible pressure transmission membrane, and the two parts of the measurement path can be filled with a gel that is impermeable to liquids and gases.

[0104] This reduces potential losses when transferring pressure to the pressure sensor, as air, for example, as a compressible medium, is replaced by the gel. More preferably, the gel can be biocompatible. Attached Figure Description

[0105] The following description, with reference to the accompanying drawings, explains non-limiting examples of this disclosure, wherein: Figure 1 An embodiment of the inhalation therapy device according to the present disclosure is shown in perspective.

[0106] Figure 2 It shows along Figure 1 A schematic cross-sectional view of the flow path of an inhalation therapy device.

[0107] Figure 3 A frontal cross-sectional view of the aerosol generator of the inhalation therapy device is shown, wherein the cross-section is taken perpendicular to the first flow direction.

[0108] Figure 4 An exploded view of the atomizer housing is shown, which can be connected to the controller housing shown in the additional diagram; together they form a... Figure 1 Inhalation therapy device.

[0109] Figure 5 A schematic enlarged partial cross-sectional view through a portion of the atomizer housing and a portion of the controller housing is shown to illustrate the corresponding configuration and arrangement of the pressure transmission components in the atomizer housing and the controller housing. Detailed Implementation

[0110] The present preferred embodiment of the present disclosure relating to an inhalation therapy device 1 will now be described with reference to the accompanying drawings. This inhalation therapy device 1 is also commonly referred to as an "aerosol delivery device" or "nebulizer," for example, for therapeutic purposes via a user's respiratory system.

[0111] Figure 1 An exemplary isometric view of an inhalation therapy device 1 according to a currently preferred embodiment of the present disclosure is shown.

[0112] The overall shape of the inhalation therapy device 1 is defined by its housing 2, which is divided into two main parts. The housing 2 includes an atomizer housing 3 and a controller housing 4. The atomizer housing 3 can also be interpreted as the aerosolization part, and the controller housing 4 can also be referred to as the controller part or the holding part.

[0113] However, this disclosure is not limited to such a separate configuration: the atomizer housing 3 and the controller housing 4 constituting the housing 2 of this embodiment can also be formed as a single unit. However, such a configuration will not be discussed in more detail here.

[0114] The atomizer housing 3 houses an aerosol generator 5, which is configured to generate an aerosol from a liquid or fluid (i.e., a pharmaceutical agent), as will be described in the following reference. Figure 2 , Figure 3 and Figure 5 To describe in more detail.

[0115] The controller housing 4 is generally designed to allow the inhalation therapy device 1 to be held by the user during (aerosol) therapy and contains the most relevant, preferably all, electronic features and sensing elements required to operate the inhalation therapy device 1 and monitor the treatment process.

[0116] Therefore, the controller housing 4 can be interpreted as a durable component, requiring less cleaning and / or sterilization compared to the nebulizer housing 3, which can be configured as a disposable product or a product intended for use over a certain period of time (such as a certain number of treatments, weeks, months, or years). For example, the nebulizer housing 3 and the aerosol generator 5 can be replaced every month, every three months, or every year (annual package).

[0117] To date, in the use state of the inhalation therapy device 1, the position of the nebulizer housing 3 relative to the controller housing 4 is at least temporarily fixed by interlocking fasteners, and thereby the nebulizer housing 3 can be reversibly attached to and removed from the controller housing 4 via the interlocking fasteners, so as to facilitate the cleanliness of both parts of the housing 2 and the replacement of the nebulizer housing 3. Figure 2 , Figure 4 and Figure 5 It is evident that the interlocking fastener can be implemented, for example, by a spring hook 23. The illustrated spring hook 23 is exemplarily arranged at the front section of the controller housing 4, interacting with a recess formed in the nebulizer housing 3 to stabilize the relative position of the nebulizer housing 3 with respect to the controller housing 4 during use of the inhalation therapy device 1. Therefore, having this spring hook 23 eliminates the need for an opening mechanism.

[0118] To facilitate obtaining the correct relative position of the controller housing 4 and the nebulizer housing 3, a preferred embodiment of this disclosure additionally includes interacting magnets (not shown). These are respectively arranged in the controller housing 4 and the nebulizer housing 3 to support the controller housing 4 and the nebulizer housing 3 in place, wherein interlocking fasteners—temporarily securing the relative position of the two housing portions during use of the inhalation therapy device 1—and secure the following airtight connection of the two portions 15.1 and 15.2 of the measurement passages in the nebulizer housing 3 and the controller housing 4.

[0119] To achieve good cleanliness and / or disinfection of the atomizer housing 3 and easy access to the aerosol generator 5 arranged inside the atomizer housing 3, from Figure 1 and Figure 4 As clearly visible, latch 6 is located at the atomizer housing 3. Latch 6 allows access to the interior of the atomizer housing 3, especially to the aerosol generator 5 disposed therein. To date, Figure 1 The inhalation therapy device 1 is shown when the latch 6 holds the nebulizer housing 3 in a closed state, while Figure 4 The same device in the open state is shown, such that ( Figure 4(Not shown) The aerosol generator 5 can be accessed. However, the latch 6 is not mandatory. A nebulizer housing 3 that cannot be opened by the user, operator, hospital staff, or patient can also be provided. This can be achieved, for example, by forming a nebulizer housing 3 in which the aerosol generator 5 is positioned in a fixed location and cannot be accessed / replaced.

[0120] In a given technical field, such as Figure 3 The aerosol generator 5 illustrated herein is often referred to as a diaphragm unit or head unit. Similarly, the atomizer housing 3 is referred to as a "nebset," which reflects the abbreviation for nebulization set. Alternatively, "nebset" is also referred to as a "mouthpiece assembly" (MPA), which includes the diaphragm unit (also known as the head unit) and the mouthpiece for the user.

[0121] A preferred embodiment is an inhalation therapy device 1 through which the user inhales and exhales during treatment. That is, the inhalation therapy device 1 contacts the user's mouth, for example, via a mouthpiece, or via a (face) mask, for example, so that the user's normal inhalation and exhalation are performed through the inhalation therapy device 1. Specifically, the inhalation therapy device 1, particularly its first opening 7 (which will be described in more detail below), should not be removed from the user's mouth (and nose) during aerosol therapy.

[0122] The generation of aerosols within the inhalation therapy device 1 and the actual treatment will now be described in more detail.

[0123] Figure 2 The illustration shows the orientation when the patient holds the inhalation therapy device 1 in an ideal position during treatment, i.e., the patient is seated and the patient's head is upright. For orientation purposes, only the uppermost section of the controller housing 4 is shown when the inhalation therapy device 1 is held in the said ideal position. Meanwhile, Figure 2 A cross-sectional view is shown along the flow path 8 through the inhalation therapy device 1 and Figure 5 A schematic enlarged partial cross-sectional view through a portion of the atomizer housing and a portion of the controller housing is shown to illustrate the corresponding configuration and arrangement of pressure transmission components within the atomizer housing and the controller housing. In this respect, the atomizer housing 3 is illustrated to include a flow path 8 through the atomizer housing 3, and an aerosol generator 5 is disposed within the flow path 8. In the illustrated embodiment, the flow path 8 corresponds to a space in which pressure is measured. In other embodiments, the space may be separate from the flow path 8, but fluidly connected or communicating with it, such that the pressure in the space is meaningful or indicative of the flow (pressure) in the flow path.

[0124] exist Figure 2 and Figure 5 In the illustrated location, a reservoir 9 for holding liquid or fluid (i.e., medication) is located in the upper section of the nebulizer housing 3. Additionally, a cover 10 is provided on the upper section of the reservoir 9 to ensure that the fluid or liquid in the reservoir 9 does not overflow during treatment.

[0125] To generate an aerosol for therapeutic use, an aerosol generator 5, arranged in a flow path 8 through the nebulizer housing 3, includes a membrane unit comprising an aerosol-generating membrane 11 and an actuator 12, which are connectable via a plug 24. This is in Figure 3 A more detailed illustration is provided. Conversely, for easier orientation, [the following is an example]. Figure 4 No membrane unit is illustrated. For example, as described in the... Figure 3 It is evident that actuator 12 can be configured as a piezoelectric ring or an oscillator. Figure 3 In this process, the actuator 12 is a piezoelectric crystal that surrounds the aerosol-generated film 11 in a circular manner and is bonded to the substrate.

[0126] exist Figure 2 In the cross-sectional view, the aerosol generating membrane 11 is arranged in an upright position, i.e., a vertical position, within the nebulizer housing 3, such that the aerosol generating membrane 11 can come into contact with the fluid or liquid held in the reservoir 9. In other words, the reservoir 9 and the aerosol generating membrane 11 are arranged adjacent to each other such that when the fluid or liquid is held in the reservoir 9, the fluid or liquid can be supplied to the first side 11.1 of the aerosol generating membrane 11. This allows the fluid or liquid to be automatically (i.e., by gravity) delivered to the aerosol generating membrane 11 of the aerosol generator 5 to generate aerosol for the user's treatment. This is achieved by positioning the aerosol generating membrane 11 at its lowest position in the reservoir 9 when the user holds the inhalation therapy device 1 during treatment (see [link to relevant documentation]). Figure 2 ).

[0127] from Figure 3 As can be clearly seen, the aerosol generating membrane 11 includes a plurality of orifices (not shown), and the actuator 12 is coupled to the aerosol generating membrane 11 such that it can vibrate the aerosol generating membrane 11. In doing so, liquid passes through the orifices and aerosol is generated at the second side 11.2 of the aerosol generating membrane 11 opposite to its first side 11.1. That is, within the chamber inside the atomizer housing 3... Figure 2 Aerosol plumes are generated on the left side of the aerosol generator 5. These aerosol plumes can also be understood as "aerosol streams".

[0128] In order to entrain and deliver the aerosol generated at the second side 11.2 of the aerosol generating membrane 11 inside the nebulizer housing 3 of the inhalation therapy device 1 to the user's respiratory tract, the inhalation therapy device 1 includes a flow path 8.

[0129] The flow path 8 includes a first opening 7 at one end leading to the outside of the housing 2 (particularly the atomizer housing 3), and a second opening 13 at the other end leading to the outside of the housing 2 (particularly the atomizer housing 3).

[0130] exist Figure 2 In the illustrated embodiment, the first opening 7 and the second opening 13 of the flow path 8 are arranged on opposite sides of the atomizer housing 3. However, this arrangement is not restrictive and may also be, for example, arranged off-center from the longitudinal axis passing through the first opening 7 of the flow path 8.

[0131] As mentioned above, the first opening 7 may come into contact with the user’s airway, directly or indirectly through the user’s mouth and optionally through his or her nose, for example, via a mouthpiece or mask, so that inhalation and exhalation can be performed through the flow path 8 of the inhalation therapy device 1 during aerosol therapy.

[0132] Conversely, the second opening 13 allows air to enter and exit the flow path 8. Therefore, the flow path 8 and its first opening 7 and second opening 13 leading to the outside of the nebulizer housing 3 enable the generation of a flow in the flow path 8 in a first flow direction A from the second opening 13 to the first opening 7 when the user inhales at the first opening 7. This flow can be understood as an inhalation flow, in which the entire flow volume along the first flow direction A to the first opening 7 passes through the second opening 13 into the flow path 8, passes through the measuring passage 15 (which will be described in more detail below) and the aerosol generator 5, and merges with the aerosol at the second side 11.2 of the aerosol generating membrane 11, before being discharged from the inhalation therapy device 1 into the user's body at the first opening 7 of the flow path 8.

[0133] exist Figure 2 In one embodiment, when a user exhales at the first opening, the entire flow volume along the second flow direction B (i.e., the direction of exhalation flow from the first opening 7 to the second opening 13) also passes through the second opening 13 and enters the flow path 8.

[0134] Figure 2 The diagram illustrates the first flow direction A, i.e. the direction of inhalation flow, from the second opening 13 to the first opening 7 in the flow path 8, and the second flow direction B, i.e. the direction of exhalation flow, from the first opening 7 to the second opening 13.

[0135] Regarding the shape of flow path 8, from Figure 2It is clearly visible that the shape of the flow path 8 is designed to prevent air from flowing directly (non-redirectingly) from the second opening 13 to the first opening 7, and vice versa. This exemplary flow through the flow path 8 in the atomizer housing 3 is caused by... Figure 2 The diagram is illustrated by line C. It is evident that the center points of the cross-sections of the first opening 7, the aerosol generator 5, and the second opening 13 are not aligned with a single axis, thereby causing a redirection of the air passing through the inhalation therapy device 1 and thus avoiding a pipe-shaped flow path structure.

[0136] As from Figure 3 A frontal cross-sectional view of the aerosol generator 5 of the inhalation therapy device 1 clearly shows that the aerosol generator 5 is disposed in the flow path 8, and thus disposed in the flow that can be generated by the user's breathing (especially his or her inhalation and exhalation), so that it can be surrounded by the flow through the flow path 8. Figure 3 As illustrated, the aerosol generating membrane 11 is arranged via three webs 21 and held in an axially and circumferentially centered position in the flow path 8, such that during the user's inhalation and exhalation through the inhalation therapy device 1 during treatment, the sheath envelope flow can pass through the entire effective area of ​​the aerosol generator 5 inside the flow path 8.

[0137] Figure 2 Line C extending from the second opening 13 to the first opening 7 represents an exemplary flow of air (i.e., a suction (air) flow) along the first flow direction A. However, it should be understood that this exemplary flow path 8 is not limited to the flow passing below the aerosol generator 5, through the lowest point of the flow path 8, and across the aerosol generator 5 toward the first opening 7. This is merely one example of the flow illustrated through a cross-section of the flow path 8. In reality, the flow is a sheath envelope flow (see...). Figure 3 It passes through the aerosol generator 5 and the illustrated reservoir 9, for example, also on the side of the aerosol generator 5, because it is arranged such that an envelope flow is generated around the circumference of the aerosol generating film 11 of the aerosol generator 5.

[0138] During inhalation, the airflow is redirected to be directed around the aerosol generating membrane 11 of the aerosol generator 5 for entraining and delivering the generated aerosol.

[0139] To trigger the actuator 12 of the aerosol generator 5 and assess the quality of inhalation therapy, it is necessary to observe the manner in which inhalation and exhalation are performed via the inhalation therapy device 1. To date, preferred embodiments have provided an easily manufactured and sterilized solution that reliably monitors / measures the pressure and negative pressure within the flow path 8 as flow parameters within the flow path 8 during inhalation and exhalation.

[0140] For this purpose, the inhalation therapy device 1 includes a sensor 14, which is disposed in the controller housing and configured to detect the pressure value inside the flow path 8.

[0141] from Figure 2 and Figure 5 The illustration of the inhalation therapy device 1 clearly shows that, in addition to a controller (not shown), the controller housing 4 also houses the sensor 14. The controller is configured to control the aerosol generator 5, i.e., it is configured to trigger the actuator 12 to generate an aerosol for therapy. Therefore, the sensor 14, arranged in the controller housing 4, is positioned outside the flow path 8 extending through the nebulizer housing 3.

[0142] To provide observation of pressure values ​​in the flow path 8 via sensor 14, the inhalation therapy device 1 includes a measurement passage 15 connecting the flow path 8 and sensor 14. Considering that the flow path 8 extends through the nebulizer housing 3 and the sensor 14 is securely housed in the controller housing 4, the measurement passage 15 includes a portion 15.1 formed in the nebulizer housing 3 and a portion 15.2 formed in the controller housing 4. In a preferred embodiment, the entire measurement passage 15 has a circular shape, and the central axes of the portion 15.1 formed in the nebulizer housing 3 and the portion 15.2 formed in the controller housing 4 are aligned with each other, such that the portion 15.1 formed in the nebulizer housing 3 and the portion 15.2 formed in the controller housing 4 form a single airtight cylindrical channel, hose, tube, etc., which interconnects the flow path 8 and sensor 14 without disrupting the flow slowdown in the measurement passage 15 due to turbulence or other disturbances. Therefore, the pressure generated by the patient's inhalation and exhalation can be slowed down by the flow path 8 and the measurement passage 15 so that it can be detected by sensor 14. In the given exemplary embodiment, the airtightness is achieved by the sealing lip 22 between portion 15.1 formed in the nebulizer housing 3 and portion 15.2 formed in the controller housing 4. Nevertheless, when using the inhalation therapy device, the airtightness between portion 15.1 formed in the nebulizer housing 3 and portion 15.2 formed in the controller housing 4 can also be achieved by providing an O-ring or by the shape fit between portion 15.1 formed in the nebulizer housing 3 and portion 15.2 formed in the controller housing 4.

[0143] For example, as from Figure 5As is clearly seen, the sealing lip 22 of the exemplary embodiment accommodates the pressure transmission member 17 and is positioned within the atomizer housing 3 by having two undercuts along the axial direction of the sealing lip 22. Therefore, the sealing lip 22 combines the functions of positioning the pressure transmission member 17 within portion 15.1 of the measurement passage 15 formed within the atomizer housing and of providing an airtight seal between portion 15.1 and portion 15.2 disposed within the controller housing 4.

[0144] When viewed from the direction of the inhalation flow A, the connection between the measurement passage 15, particularly portion 15.1 of the measurement passage 15 in the atomizer housing 3, and the flow path 8 is located upstream of the aerosol generator 5 in the flow path 8. To illustrate this, the aerosol generator 5 is located upstream of the aerosol generator 5. Figure 4 The atomizer housing 3 shown in the diagram is hidden when it is open. Figure 2 and Figure 5 The configuration is also illustrated.

[0145] like Figure 2 and Figure 5 As illustrated, the arrangement of the measurement passage 15 allows the sensor 14 to be positioned away from the flow path 8. In an exemplary embodiment, the pressure sensor 14 is a differential pressure sensor that determines the static pressure in the flow path 8 and compares it with ambient pressure (i.e., a reference pressure), which can also be understood as surrounding pressure. To detect the ambient pressure, the controller housing 4 may additionally include a hose 16 extending through the controller housing 4, which is capable of detecting the ambient pressure and comparing it with the pressure in the flow path 8 via the differential pressure sensor 14. In this scenario, the hose 16 is part of the measurement passage 15, specifically part 15.2 of the measurement passage within the controller housing 4.

[0146] In an exemplary embodiment, when viewed from the first flow direction A, not only the measuring passage 15 but also the second opening 13 of the flow path 8 is arranged upstream of the aerosol generator 5. In this respect, from... Figure 2 , Figure 4 and Figure 5 It is clearly visible that the second opening 13 is located in the upper half of the atomizer housing 3.

[0147] In addition, from Figure 2 and Figure 5As clearly seen in the cross-sectional view, when viewed along the first flow direction A, the measurement passage 15 is essentially positioned midway between the aerosol generator 5 and the second opening 13 in the flow path 8. However, this arrangement is not particularly restrictive, and the interconnection between the measurement passage 15 and the flow path 8 can also be arranged in the flow path 8 closer to the second opening 13 than the aerosol generator 5, or even the measurement passage 15 can be arranged in the flow path 8 closer to the aerosol generator 5 than the second opening 13.

[0148] To best protect the sensor 14, connected to the flow path 8 via the measurement passage 15, from liquids, aerosols (droplets), phlegm, etc., and to allow safe and reliable cleaning of the inhalation therapy device 1 even when the nebulizer housing 3 and the controller housing 4 are disassembled, the inhalation therapy device 1 according to the preferred embodiment illustrated in this disclosure includes two pressure transmission members 17, 18. One pressure transmission membrane 17 seals / encloses a portion 15.1 of the measurement passage 15 in the nebulizer housing 3, while the other pressure transmission membrane 18 seals / encloses / encloses / encloses a portion 15.2 of the measurement passage 15 in the controller housing 4.

[0149] In this respect, pressure transmission components 17 and 18 are configured to transmit pressure in the flow path 8 to the sensor 14 while being impermeable to liquid. Both pressure transmission components 17 and 18 have a basic cylindrical structure, and their surfaces oriented towards the interconnection area between the controller housing 4 and the atomizer housing 3 are hydrophobic to prevent any liquids, fluids, phlegm, etc., from adhering to the pressure transmission components 17 and 18, which could otherwise potentially affect or even interfere with the pressure transmission through the pressure transmission components 17 and 18 to the sensor 14 via the measurement passage 15 (see [link to relevant documentation]). Figure 2 and Figure 5 ).

[0150] Each of the pressure transmission components 17 and 18 in the illustrated embodiment is configured as a rigid, non-deflecting body that closes the corresponding portions 15.1 and 15.2 of the measurement passage 15 and allows pressure transmission due to its liquid impermeability but gas permeability, especially air permeability.

[0151] To date, the corresponding non-deflection body in this embodiment has been constructed from KÖPP VYON 1.5M material with a thickness of 1.5 mm. That is, the non-deflection body is composed of a porous (filtering) material made of PE with a pore size ranging from 5 to 35 µm, an average pore size of 10 µm, and a thickness of 1.5 mm. At this thickness, the non-deflection body exhibits 3 m... 3 / min / m 2 The gas permeability, and / or having 6 m at a pressure difference of 10 mbar.3 / min / m 2 The gas permeability, and / or having 13 m at a pressure difference of 20 mbar. 3 / min / m 2 Gas permeability.

[0152] Independently, the non-deflecting body includes a diameter of 10 mm, but is not limited to the exemplary diameter stated herein. Due to the characteristics of the pressure transmission members 17 and 18, which are respectively configured as non-deflecting bodies for use as filters for liquids, the diameters used to transmit pressure through the respective pressure transmission members 17 and 18, and thus the effective area used to transmit pressure, can vary depending on the device size, environmental conditions, and / or intended use.

[0153] from Figure 2 and Figure 5 As is clearly visible, the sensor 14 in the controller housing 4 is not in direct contact with the pressure transmission membrane 18, which closes a portion 15.2 of the measurement passage 15 between the sensor 14 and the pressure transmission membrane 18 in the controller housing 4. Instead, the pressure transmission membrane 18 and the sensor 14 are spaced apart from each other. In the exemplary embodiment illustrated in the figures, the volume is 775 mm³.

[0154] However, this disclosure is not limited to the configuration of pressure transmission components 17, 18 consisting of non-deflecting bodies.

[0155] In contrast, one or both of the non-deflection bodies of pressure transmission components 17 and 18 may be replaced by a liquid- and gas-impermeable gel configured to transmit pressure in the flow path 8 to sensor 14.

[0156] As a further alternative, one or both of the non-deflecting bodies of pressure transmission components 17 and 18 may be replaced by a flexible pressure transmission membrane that is impermeable to liquids and gases and is simultaneously configured to transmit pressure in flow path 8 to sensor 14 due to deflection (i.e., oscillation) of the corresponding pressure transmission membrane caused by pressure in flow path 8.

[0157] In this scenario, the effective area of ​​the pressure-transmitting membrane, i.e., the pressure-transmitting membrane formed, for example, from TPE, should be formed to be as large as possible, such that the diameter can be selected, for example, as 10 mm.

[0158] Unlike the non-deflecting body mentioned above, the flexible pressure-transmitting membrane should be formed as thin as possible to achieve reliable deflection with minimal loss during inhalation and exhalation via the inhalation therapy device 1, while remaining robust enough to prevent any breakage during cleaning. Therefore, in this exemplary embodiment, the thickness of the pressure-transmitting membrane forming the pressure-transmitting member 17 and / or pressure-transmitting member 18 can be, for example, 0.4 mm, 0.5 mm, or 0.6 mm.

[0159] Furthermore, in a given context, the hardness of the pressure-transmitting membrane can range from 10 to 100 Shore A, and for two pressure-transmitting membranes, 80 Shore A can be selected as an example.

[0160] However, this disclosure is not limited to this configuration of the thickness, diameter, and material of the flexible pressure-transmitting membranes. To minimize the losses discussed above due to pressure transmission through the pressure-transmitting membranes 17, 18, the thickness, stiffness, diameter, and / or material configuration of one or both pressure-transmitting membranes 17, 18 can also be adjusted. This includes the pressure-transmitting membrane 17 in the atomizer housing 3 having a different configuration than the pressure-transmitting membrane 18 in the controller housing 3. Of course, this also applies to the configuration of the non-deflection body discussed above.

[0161] The second opening 13 can be shaped such that it can be considered a flow restrictor. To achieve the desired flow resistance, a geometry is established that causes higher flow resistance in the inhalation flow direction than in the exhalation flow direction. Typical relationships between inhalation and exhalation flow resistance established by the shape of the second opening are 125%, 130%, 150%, 175%, 190%, or even 300%, 400%, or 500%. In the most preferred embodiment, the relationship between inhalation and exhalation flow resistance established by the shape of the second opening is 190%. This allows for an advantageously longer inhalation time while simultaneously shortening the exhalation time.

[0162] Now refer to Figure 2 To describe in more detail, the actual shape of the second opening 13 is responsible for treating it as the current limiter mentioned above.

[0163] For this purpose, the second opening 13 of the flow path is designed as a passive valve with a fixed geometry. The second opening 13 can be formed as an integral part of the nebulizer housing 3, or as a separate structural element connected to the nebulizer housing 3 and forming an outlet through the flow path 8 of the nebulizer housing 3, for delivering the generated aerosol to the user during treatment.

[0164] from Figure 2It can be seen that the cross-sectional shape of the second opening 13 continuously decreases along the second flow direction B. This continuously decreasing cross-sectional shape of the second opening 13 along the second flow direction B makes it possible to make the flow resistance in the second flow direction B lower than the flow resistance in the first flow direction A, without the need for any active elements such as actuating valves.

[0165] In another embodiment, a third opening 19 leading to the outside of the atomizer housing 3 may also be provided in the flow path 8 between the first opening 7 and the second opening 13.

[0166] This is for example in Figure 1 The diagram shows that, when viewed in the first flow direction A, the third opening 19 is located upstream of the aerosol generator 5. Furthermore, the third opening 19 is equipped with a check valve 20, which is configured to restrict flow through the third opening 19 in the first flow direction A. That is, the check valve 20 prohibits any flow through the third opening 19 during intake. However, the check valve 20 is also configured to allow flow through the third opening 19 in the second flow direction B, from the first opening 7 to the second opening 13, thereby allowing air to be discharged at least partially, and preferably substantially entirely, through the third opening 19.

[0167] This configuration allows for the desired inhalation flow resistance to be achieved, while also allowing for a further reduction in exhalation flow resistance, as the check valve 20 facilitates the discharge of air via the check valve 20 and the third opening 19 of the flow path 8.

[0168] Regardless of the presence of the third opening 19, in another embodiment (not shown), the inhalation therapy device 1 may include an air filter reversibly attachable and detachable relative to the nebulizer housing 3. The air filter is configured to filter harmful substances from the exhaled flow. The exhaled flow may contain substances and / or aerosols that may contain materials or bacteria that are potentially harmful to the environment. If the third opening 19 is present, the air filter is shaped to also cover the third opening 19 and its check valve 20, such that during exhalation, the flow in the second flow direction B primarily / also passes through the air filter to reach the outside of the nebulizer housing 3. Conversely, if the third opening 19 is absent and the flow path 8 extends only between the first opening 7 and the second opening 13, the air filter is shaped to cover the second opening 13, which is the only opening of the flow path 8, besides the first opening 7, to the outside of the nebulizer housing 3, such that during inhalation, the entire flow volume along the first flow direction A passes through the air filter, and during exhalation, the entire flow volume along the second flow direction B passes through the air filter.

[0169] List of reference numerals

[0170] 1. Inhalation therapy device

[0171] 2. Shell

[0172] 3. Atomizer housing

[0173] 4. Controller housing

[0174] 5 Aerosol Generator

[0175] 6. Latch

[0176] 7. The first opening in the flow path

[0177] 8. Flow path (space)

[0178] 9. Storage

[0179] 10 lids

[0180] 11 Aerosol Formation Membrane

[0181] 11.1 First side of the aerosol-forming film

[0182] 11.2 Second side of the aerosol-forming film

[0183] 12 Actuators

[0184] 13. The second opening in the flow path

[0185] 14. Sensor (Pressure Sensor)

[0186] 15 Measurement Path

[0187] 15.1 Measurement passage portion in the atomizer housing

[0188] 15.2 Measurement path portion within the controller housing

[0189] 16 Hose

[0190] 17 Pressure transmission components in the atomizer housing

[0191] 18 Pressure transmission components in the controller housing

[0192] 19 Third Opening

[0193] 20 Check valve

[0194] 21. Web

[0195] 22 Sealing Lip

[0196] 23 Spring Hook

[0197] 24 Plugs

[0198] A. First flow direction (inhalation flow direction)

[0199] B. Second flow direction (exhalation flow direction)

[0200] C. An exemplary flow through a flow path

Claims

1. An inhalation therapy device (1), the inhalation therapy device comprising: Shell (2); Aerosol generator (5), the aerosol generator being configured to generate aerosols from liquid. A space defined within the housing (2), fluidly connected to a first opening (7) leading to the exterior of the housing (2) and a second opening (13) leading to the exterior of the housing (2), wherein, when a patient inhales at the first opening (7), at least an inhalation flow (A) is generated from the second opening (13) to the first opening (7) for entrainment and delivery of the generated aerosol. A measurement path (15) connects the space (30) and a sensor (14), wherein the sensor (14) is located outside the space and configured to detect pressure in the space via the measurement path (15), and A pressure transmission component for transmitting pressure in the space to the sensor (14). The pressure transmission components (17, 18) seal the measurement passage (15) and are impermeable to liquid.

2. The inhalation therapy device (1) according to claim 1, wherein, At least one surface of the pressure transmission member (17, 18) oriented away from the sensor (14) includes hydrophobic properties.

3. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The housing (2) includes: Atomizer housing (3), the atomizer housing defining the space and accommodating the aerosol generator (5), and A controller housing (4) housing a controller configured to control the aerosol generator (5) and the sensor (14). The atomizer housing (3) is detachable from the controller housing (4). Wherein, a portion (15.1) of the measurement passage (15) is formed in the atomizer housing (3), and another portion (15.2) of the measurement passage (15) is formed in the controller housing (4), and The pressure transmission components (17, 18) close the other part (15.2) of the measurement passage (15) in the controller housing (4) or the part (15.1) of the measurement passage (15) in the atomizer housing (3).

4. The inhalation therapy device (1) according to claim 3, wherein, In the use state of the inhalation therapy device (1), the position of the nebulizer housing (3) relative to the controller housing (4) is fixed by interlocking fasteners and / or interacting magnets to ensure an airtight connection between the other part (15.2) of the measurement passage (15) in the controller housing (4) and the part (15.1) of the measurement passage (15) in the nebulizer housing (3) in the use state of the inhalation therapy device (1).

5. The inhalation therapy device (1) according to claim 3 or 4, wherein, The inhalation therapy device (1) includes two pressure transmission members (17, 18), wherein one pressure transmission member closes the other portion (15.2) of the measurement passage (15) in the controller housing (4), and the other pressure transmission member closes the portion (15.1) of the measurement passage (15) in the nebulizer housing (3).

6. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The space is connected to a flow path (8) or a flow path (8) including a first opening (7) located at one end of the flow path (8) and a second opening (13) located at the other end of the flow path (8), wherein when the patient inhales at the first opening (7), the inhalation flow (A) from the second opening (13) to the first opening (7) can be generated in the flow path (8) for entraining and delivering the generated aerosol.

7. The inhalation therapy device (1) according to claim 6, wherein, When viewed in the direction of the inhalation flow (A), the aerosol generator (5) is positioned in the flow path (8) between the first opening (7) and the second opening (13), and the connection between the measurement passage (15) and the flow path (8) is located upstream of the aerosol generator (5) in the flow path (8).

8. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The housing (2) includes a support surface for supporting the inhalation therapy device (1) on a horizontal surface, and The pressure transmission components (17, 18) are arranged at an angle relative to the support surface.

9. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The pressure transmission components (17, 18) are non-deflecting bodies that are impermeable to liquids but permeable to gases, for transmitting pressure in the space to the sensor (14).

10. The inhalation therapy device (1) according to claim 9, wherein, The thickness of the non-deflecting body ranges from 0.1 mm to 5 mm, preferably from 0.5 mm to 3 mm, more preferably from 0.5 mm to 2.5 mm, and most preferably from 1 mm to 2 mm.

11. The inhalation therapy device (1) according to claim 9 or 10, wherein, The non-deflection body is composed of a porous material with a pore size in the range of 0.1 to 50 μm, preferably in the range of 2 to 40 μm, more preferably in the range of 3 to 35 μm, and most preferably about 10 μm.

12. The inhalation therapy device (1) according to claim 10 or 11, wherein, The non-deflection body comprises a thickness of 1.5 mm and a pressure differential of 0.01 to 10 m under a pressure difference of 5 mbar. 3 / min / m 2 The gas permeability is preferably 0.1 to 10 m³ under a pressure difference of 5 mbar. 3 / min / m 2 The gas permeability is more preferably 0.4 to 4 m at a pressure difference of 5 mbar. 3 / min / m 2 Gas permeability.

13. The inhalation therapy device (1) according to any one of claims 9 to 12, wherein, The diameter of the non-deflecting body ranges from 3 mm to 50 mm, preferably from 5 mm to 20 mm, more preferably from 8 mm to 12 mm, and most preferably 10 mm.

14. The inhalation therapy device (1) according to any one of claims 9 to 13, wherein, The non-deflection body is made of PTFE, PE or PFAS alternatives, such as PAN.

15. The inhalation therapy device (1) according to any one of claims 1 to 8, wherein, The pressure transmission member (17, 18) is a flexible pressure transmission membrane that is impermeable to both liquids and gases, and the pressure transmission member is configured to transmit the pressure in the space to the sensor (14) due to the deflection of the pressure transmission membrane caused by the pressure in the space.

16. The inhalation therapy device (1) according to claim 15, wherein, The diameter of the pressure transmission membrane ranges from 3 mm to 50 mm, preferably from 5 mm to 20 mm, more preferably from 6 mm to 20 mm, and most preferably from 6 mm to 15 mm.

17. The inhalation therapy device (1) according to claim 15 or 16, wherein, The thickness of the pressure transmission membrane ranges from 0.1 mm to 2 mm, preferably from 0.1 mm to 1 mm, more preferably from 0.2 mm to 1 mm, and most preferably from 0.3 mm to 0.5 mm.

18. The inhalation therapy device (1) according to any one of claims 15 to 17, wherein, The pressure transmission membranes (17) and (18) are made of elastomer, thermoplastic elastomer (TPE), latex or silicone resin.

19. The inhalation therapy device (1) according to any one of claims 15 to 18, wherein, The volume between the pressure transmission membrane and the sensor (14) is greater than 1 mm³, preferably greater than 5 mm³, and less than 1600 mm³, preferably less than 1000 mm³, and more preferably less than 800 mm³.

20. The inhalation therapy device (1) according to any one of claims 15 to 19, wherein, The hardness range of the pressure transmission membrane is from 10 to 100 Shore A.

21. The inhalation therapy device (1) according to any one of claims 1 to 8, wherein, The pressure transmission components (17, 18) are liquid- and gas-impermeable gels configured to transmit pressure in the space to the sensor (14).

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