Inhalation therapy device

Abstract

The present disclosure relates to an inhalation therapy device. The inhalation therapy device comprises a housing body, a reservoir for holding a liquid, a membrane unit, and a valve. The membrane unit comprises an aerosol-generating membrane and an actuator. The aerosol-generating membrane is disposed in the housing body and comprises a plurality of pores. The membrane is disposed such that, when the liquid is held in the reservoir, the liquid is supplied to a first side of the aerosol-generating membrane by gravity. The actuator is coupled to the aerosol-generating membrane for vibrating the aerosol-generating membrane, whereby the liquid passes through the plurality of pores, an aerosol is generated at a second side of the aerosol-generating membrane opposite the first side, and a negative pressure is established in the reservoir. The valve is configured to open when an amount of the negative pressure in the reservoir reaches a threshold value upon use of the inhalation therapy device, in particular upon vibration of the aerosol-generating membrane, and to close when the amount of the negative pressure falls below the threshold value.

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 pharmaceuticals (such as drugs and vaccines) to the user in aerosol form via the user's respiratory system. Inhalation therapy devices can also be used for diagnostic purposes, such as performing lung provocation tests using radioactive isotopes. For therapeutic purposes, aerosol inhalation is a preferred route of administration for certain medications 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 mass median aerodynamic diameter (MMAD) of less than 5 μm or even less than 4 μm and at least 1 μm are required to allow deposition at the intended sites in the respiratory system.

[0004] Therapeutic aerosols are generated and delivered to the user's body, particularly to the desired location in the user's respiratory tract, using an inhalation therapy device. For this purpose, the fluid to be aerosolized or nebulized, especially a liquid (i.e., a drug, medicine, vaccine, etc.), 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 includes an aerosol generator.

[0006] Such an aerosol generator may, for example, include a membrane unit comprising an aerosol generating membrane having multiple pores and an actuator directly or indirectly connected to the aerosol generating membrane via a support plate supporting the aerosol generating membrane for vibrating the aerosol generating membrane.

[0007] A fluid or liquid can come into contact with a first side of the aerosol-generating membrane by gravity. The fluid or liquid (i.e., a reagent) passes through multiple pores from the first side and generates an aerosol on a second side opposite the first side of the aerosol-generating membrane when the membrane is vibrated.

[0008] A fluid or liquid atomized or nebulized within an inhalation therapy device (i.e., an aerosol) is subsequently supplied to the user's respiratory system within the scope of inhalation therapy when inhaled by the user through the inhalation therapy device. This means that, as the user breathes, and especially as he or she applies suction through inhalation via the inhalation therapy device, the aerosol is at least partially (through suction) delivered from within the inhalation therapy device to the user's airway.

[0009] Examples of conventional inhalation therapy devices with this configuration can be found, for example, from DE 19953317C1. The membrane unit of the disclosed inhalation therapy device includes 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.

[0010] The aerosol generating membrane disclosed in DE19953 317C1 is connected to (welded) a substrate (support plate) and an oscillator, such as a piezoelectric crystal, which is circularly arranged around the aerosol generating membrane and connected to (bonded) the substrate, so that the aerosol generating membrane can oscillate by means of the oscillator and an electric drive circuit.

[0011] Thus, liquid applied to the first side of the aerosol-generating membrane is transported through pores in the oscillating aerosol-generating membrane to the second side of the aerosol-generating membrane opposite to the first side, so as to be emitted as an aerosol into the chamber. The disclosed inhalation therapy device also includes a mouthpiece or a mask connected to the chamber outlet and having an exhalation valve. Therefore, when the user exhales, the exhaled airflow will not enter or only enter the chamber to a limited extent, but will be discharged into the environment of the device through the exhalation valve (or exhalation opening).

[0012] The disclosed device continuously drives the piezoelectric crystal throughout the entire (single) treatment time (single application interval), during which virtually all the liquid in the reservoir is aerosolized through an aerosol generation membrane. During the user's exhalation, the generated aerosol is temporarily stored in the chamber, forming an aerosol cloud (clump), which is inhaled and delivered to the user's respiratory tract for treatment. Therefore, the treatment time can be kept relatively short.

[0013] 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 walls of the device (especially in the chamber) increases; this aerosol deposited on the inner walls of the device is known as rainout. This leads to an increase in the loss of applicable aerosols / drugs.

[0014] Other conventionally known inhalation therapy devices only activate the piezoelectric crystal during inhalation and deactivate it during exhalation. These inhalation therapy 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 administration intervals), which can be annoying to users and lead to poor user adherence, for example, interrupting treatment or prematurely ending treatment before the intended dose of liquid or fluid in the reservoir has been nebulized and delivered to the user's airway for treatment.

[0015] The two conventional inhalation therapy devices described above typically operate in such a manner that the user inhales only through the device, i.e., 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 allow the user to exhale without resistance, overall treatment monitoring is unsatisfactory because data, such as flow parameters in the device's flow path, is not available during exhalation, preferably by detecting pressure within the flow path. Furthermore, in the case of continuous operation, the generated aerosol is lost without any therapeutic effect on the user.

[0016] In addition, removing the inhalation therapy device with each exhalation can negatively impact the user's natural breathing (i.e., his or her stable breathing cycle).

[0017] Therefore, conventional systems face the need for an effective inhalation therapy device that can achieve a short overall treatment time (single application interval) while reducing the loss of rain and / or generated aerosols in the absence of any therapeutic effect on the user.

[0018] To achieve this, various control mechanisms for aerosol generation within inhalation therapy devices have been proposed. While the activation (during inhalation) and deactivation (during exhalation) of the piezoelectric crystal—overall—ensures that the loss of drug-containing aerosolized fluid or liquid can be reduced, turning aerosol generation on and off (i.e., triggering it at the correct time) is quite challenging.

[0019] On the one hand, aerosol generation must begin no later than the time the user starts inhaling 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.

[0020] To achieve this, the applicant has considered a so-called "pre-open / pre-close" inhalation therapy device. In this "pre-open / pre-close" inhalation therapy device, aerosol generation begins before the user actually inhales, such that a certain amount of aerosol is generated before actual inhalation, i.e., pre-inhalation aerosol similar to the aerosol clumps described above is generated, and the actuation of the piezoelectric crystal stops before exhalation begins, i.e., pre-exhalation aerosol generation is stopped.

[0021] To achieve this, all discontinuous inhalation therapy devices need to precisely monitor the user's breathing pattern at least along the inhalation direction in order to adequately control the actuation of the piezoelectric crystal and thus control aerosol generation.

[0022] Therefore, most conventional discontinuous inhalation therapy devices include sensors. Such sensors observe the flow through the inhalation therapy device and are thus necessary for the precise triggering of aerosol generation.

[0023] However, previous solutions suffer from deterioration in aerosol generation, particularly at the beginning and / or end of a single application interval, i.e., at the beginning and end of the overall treatment time. This deterioration in aerosol generation leads to the loss of rain and / or generated aerosols without any therapeutic effect on the user.

[0024] An example of a publicly disclosed first solution in this field can be found in WO2012 / 069531A2. According to the abstract of WO2012 / 069531A2, the inhalation therapy device disclosed therein includes a liquid reservoir and an aerosol-generating membrane with an opening, the liquid reservoir being configured in a sealed state to maintain an initial liquid volume V. L Volume V R A liquid reservoir is connected to an aerosol-generating membrane to supply liquid to one side of the membrane. The aerosol-generating membrane is oscillable to allow liquid to flow through an opening, thereby ejecting the liquid as an aerosol on the other side of the membrane. Before the aerosol-generating membrane is oscillated, the volume V of the liquid reservoir is... R Configured to the initial volume V of the liquid L It contains more than 5 ml of gas when the volume is at least 5 ml. Summary of the Invention

[0025] In view of the foregoing, the 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 throughout the administration interval.

[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, the inhalation therapy device includes a housing body, a reservoir for holding liquid, a membrane unit, and a valve.

[0028] The membrane unit includes an actuator and an aerosol-generating membrane disposed within the housing body and including multiple pores. The aerosol-generating membrane is configured such that, when liquid is held in the reservoir, liquid is supplied to a first side of the aerosol-generating membrane by gravity.

[0029] An actuator is connected to the aerosol generating membrane to vibrate the aerosol generating membrane, thereby holding the liquid in the reservoir and supplying it by gravity to the first side of the aerosol generating membrane through the plurality of holes, generating aerosols on the second side of the aerosol generating membrane opposite to the first side, and establishing a negative pressure in the reservoir.

[0030] The valve is configured to open when the amount of negative pressure (also understood as underpressure) in the reservoir reaches a threshold during / when the inhalation therapy device is used. Preferably, the valve is configured to open when the amount of negative pressure in the reservoir reaches the threshold during / when the aerosol-generating membrane vibrates.

[0031] In addition, the valve is configured to close when the negative pressure (amount) drops below a threshold.

[0032] As the negative pressure gradually increases during the application interval—becoming increasingly negative due to the reduction in the liquid filling volume in the reservoir caused by aerosol generation via the membrane unit—the valve allows air locked in the reservoir to exchange with the environment (i.e., the outside of the reservoir) once a threshold is reached. In this case, the valve opens, thus allowing air to enter the reservoir. This causes a decrease in negative pressure, i.e., a reduction in the negative pressure within the reservoir. In other words, the pressure in the reservoir becomes less negative. Once the negative pressure inside the reservoir drops below the threshold (i.e., the negative pressure has become less negative), the valve closes, and a certain amount of negative pressure below the threshold can still be maintained—independent of the fluid filling volume in the reservoir.

[0033] The reservoir holds the liquid or fluid in a "sealed" state during treatment, and during use, the only opening through which the liquid or fluid leaves the reservoir of the inhalation therapy device is via the pores of the aerosol-generating membrane. Simultaneously, a valve ensures that the amount of negative pressure established during treatment as more and more liquid is aerosolized through the pores of the aerosol-generating membrane remains within an acceptable range, i.e., below a certain maximum pressure value (the aforementioned threshold). This mechanism and the resulting negative pressure, and maintaining it within a certain range, ensure that all liquid or fluid (i.e., the drug) supplied to the first side of the aerosol-generating membrane by gravity is aerosolized, and that the delivered dose of the liquid or fluid (i.e., the drug) is maximized.

[0034] Preferably, the valve is a one-way valve.

[0035] This provides a simple valve configuration without requiring any electrical components, especially sensing components, to trigger the opening and / or closing of the valve. At the same time, the one-way valve effectively prevents any negative environmental influences from entering the reservoir in an undesirable manner.

[0036] More preferably, the one-way valve is an umbrella valve, which is capable of taking different opening pressures based on the Shore hardness of its material. Therefore, the umbrella valve assumes the function of a spring within the valve itself. The term "opening pressure" should be understood as the threshold of negative pressure as outlined above. This means that the umbrella valve opens when the negative pressure becomes more negative and closes when the negative pressure decreases (i.e., becomes more positive (less negative)).

[0037] However, the configuration of a check valve is not limited to such umbrella-shaped valves. Preset pressure-dependent check valves with different configurations can also be provided. For example, a spring-loaded stationary valve can also operate, just like an electronically or mechanically (actively) controlled valve.

[0038] The threshold for the amount of negative pressure is a single negative pressure value. Preferably, the single value of the threshold for the amount of negative pressure is in the range of 20 mbar to 400 mbar, such as 100 mbar or 200 mbar.

[0039] It should be understood that the actual negative pressure value may deviate in practice due to factors such as production variations, valve materials and the valve's behavior upon activation, or environmental conditions. That is, the described threshold (single value) should be understood to include a deviation of ±25 mbar or even ±50 mbar, such that the threshold can be understood as a negative pressure range around the corresponding single negative pressure value. For example, if the single negative pressure value is, for instance, 100 mbar, the actual value in practice may fall within the range of 50 mbar to 150 mbar or 75 mbar to 125 mbar. This applies to both the same device under different operating or environmental conditions, and different devices within the same series under the same conditions.

[0040] Depending on the fluid or liquid to be used for inhalation therapy, it may be further possible to use a valve configuration with a negative pressure threshold of up to 300 mbar or even up to 400 mbar as the threshold for triggering the opening and closing of the valve.

[0041] Since this disclosure uses negative pressure values ​​(i.e. negative pressure values) as triggers for opening and closing valves, the threshold of negative pressure in the reservoir that triggers both opening and closing should be understood as approximately -100 mbar or -200 mbar (see above).

[0042] Having such a negative pressure trigger value allows the delivered dose to be maintained as high as possible, and the maximum amount of liquid (i.e., the drug) held in the reservoir is aerosolized through the membrane unit for treatment.

[0043] Specifically, the negative pressure ensures that a "suction" effect is prevented from the first side of the aerosol-generating film facing the interior of the reservoir to the second side of the aerosol-generating film inside the housing body. Therefore, difficulties in initiating atomization (such as "bleeding effects," where fluid passes through the pores of the aerosol-generating film without being aerosolized, or liquid foam is retained in the reservoir) can be avoided, and the total output rate (TOR) can thus be advantageously increased.

[0044] As more and more liquid from the reservoir is aerosolized, and thus supplied from the first side of the aerosol-generating membrane to the second side, a negative pressure is established inside the reservoir. A threshold ensures that the amount of negative pressure in the reservoir, i.e. on the first side of the membrane, does not exceed the corresponding threshold given above, which may vary depending on the liquid or fluid to be aerosolized.

[0045] Simultaneously, these trigger values ​​for valve closure and opening ensure that a consistent level of negative pressure is maintained inside the reservoir during treatment, preventing liquid from passing through the pores of the aerosol-generating membrane and thus failing to function as an effective aerosol in aerosol therapy. Without this negative pressure, droplets would remain on the second side of the aerosol-generating membrane inside the housing body, without any therapeutic effect.

[0046] Preferably, the inhalation therapy device further includes a cap for sealing the opening of the reservoir.

[0047] The cap allows easy access to the reservoir used to hold the liquid, and the reservoir can be refilled after it has been opened via the cap.

[0048] Although such a (refill) opening is sealed by a cap to prevent accidental spillage of liquid, gas can still enter the reservoir when the inhalation therapy device is used, for example, when there is no liquid in the reservoir, because the gas can pass through the pores of the aerosol-forming membrane.

[0049] More preferably, the valve is arranged in the cover.

[0050] Therefore, the reservoir itself can be formed as part of the inhalation therapy device in a particularly simple and cost-effective form, while the cover including the valve contains the main structural element for generating and maintaining negative pressure throughout the treatment interval.

[0051] This valve arrangement allows the valves to be configured as a single unit. However, this disclosure is not limited to such a valve position. For example, the valves can also be arranged away from the cover. For example, the valves can be located in the side wall of the (fluid) reservoir, or can be fluidly connected to the fluid reservoir via a piping structure. However, it must be remembered and noted that the valve arrangement does not encounter the liquid filled into the (fluid) reservoir for aerosolization (i.e., for inhalation therapy). That is, it is preferable to arrange the valves above the maximum liquid fill level of the reservoir when the inhalation therapy device is held in its normal position during its therapeutic use to avoid any damage or contamination to the valves.

[0052] Preferably, the inhalation therapy device (more preferably the cover) further includes a negative pressure generating device for generating an initial negative pressure in the reservoir before the inhalation therapy device is operated (preferably before the aerosol generating membrane of the inhalation therapy device vibrates).

[0053] This results in a negative pressure already present in the (filled) reservoir when aerosolization begins via vibration of the aerosol-generating membrane. Given that the negative pressure establishes optimal conditions in the reservoir, and is crucial for optimizing the amount of fluid available for treatment, aerosol generation is further improved.

[0054] In addition, it can prevent the air volume sealed between the liquid held in the reservoir and the cap from creating positive pressure in the reservoir when the cap is closed, which could negatively affect treatment success because of the "leakage" discussed above that occurs through the pores of the aerosol-generated membrane.

[0055] It should be understood in this regard that the initial negative pressure generation in the reservoir is independent of valve actuation. If, for any reason, the amount of negative pressure built up in the reservoir exceeds a threshold (i.e., the amount of negative pressure is more negative than the valve's predetermined negative pressure threshold), the valve will open to adjust the amount of negative pressure in the reservoir to a value less negative than the threshold. This is unrelated to whether the initial pressure has already been generated by the negative pressure generating device before treatment begins.

[0056] In this respect, preferably, the cover includes a cover body, and the negative pressure generating device includes an annular seal and a movable component.

[0057] When the cap is placed on the reservoir, the annular seal is clamped at its outer circumference between the cap body and the circumferential edge of the reservoir defining the opening.

[0058] The movable component is attached to the inner circumferential portion of the seal. The movable component is configured such that, when the cap body is fastened to the reservoir, the inner circumferential portion of the seal moves away from the aerosol-generating film to generate an initial negative pressure.

[0059] This structural configuration allows for the initial negative pressure to be generated in the reservoir before the inhalation therapy begins (i.e., before the aerosol-generating membrane vibrates to generate aerosols), without requiring any electrically or mechanically actuated components. Instead, the shape of the configuration enables the negative pressure to be established before aerosol generation begins in a simple, cost-effective, and reliable manner.

[0060] Therefore, treatment success can be improved because the delivered dose can be kept as high as possible and the largest possible volume of fluid can be used for treatment.

[0061] Valves can be arranged in moving components.

[0062] This establishes a continuous negative pressure in the sealed reservoir before and during inhalation therapy using the aforementioned inhalation therapy device.

[0063] The interaction between the negative pressure generating device and the negative pressure sensitive valve arranged in the cover enables two advantageous functions to be achieved solely through the configuration of the cover throughout the entire treatment: generating negative pressure before the start of treatment and maintaining negative pressure within a preferred range that does not necessarily have to be the same as the initial negative pressure.

[0064] Therefore, such a cap can also be used to update conventional membrane atomizers to achieve the above-mentioned effects.

[0065] Furthermore, the cover configuration allows for the establishment and maintenance of an initial negative pressure without any operational steps performed by an electric operating controller or the like, and the negative pressure need not be the same as the initial negative pressure.

[0066] In addition, the arrangement of the valve in the cap (more preferably in the moving member) ensures that the liquid filled into the reservoir does not come into contact with the cap, even when the inhalation therapy device is held at a 30° tilt angle relative to an ideal position, which is the position when the inhalation therapy device is held by the user in a (standing or) sitting position with the user's head in an upright position during treatment. Attached Figure Description

[0067] The following explanation of non-limiting examples of this disclosure is made with reference to the accompanying drawings, in which: Figure 1 An embodiment of the inhalation therapy device according to the present disclosure is shown in an isometric view.

[0068] Figure 2 It shows along Figure 1 A schematic cross-sectional view of the flow path of an inhalation therapy device.

[0069] Figure 3 It shows Figure 1 An exploded view of the nebulizer housing of an inhalation therapy device.

[0070] Figure 4a and Figure 4b The operating status of the negative pressure generating device is shown.

[0071] Figure 5 A schematic diagram illustrating, exemplarily, the negative pressure curve inside the reservoir in an inhalation therapy device across single administration intervals is provided. Detailed Implementation

[0072] A presently preferred embodiment of the present disclosure relating to an inhalation therapy device 1 will now be described with reference to the accompanying drawings. Such an inhalation therapy device 1 is also commonly referred to as an "aerosol delivery device" or "nebulizer," for example, for therapeutic purposes via the user's respiratory system.

[0073] Figure 1 An exemplary isometric view of an inhalation therapy device 1 according to a currently preferred embodiment of the present disclosure is shown.

[0074] The overall shape of the inhalation therapy device 1 is defined by its housing body 2, which is divided into two main parts. The housing body 2 includes an atomizer housing 3 and a controller housing 4, which can be equivalently interpreted as the aerosolization part, and the controller housing can also be referred to as the controller part or the holding part.

[0075] However, this disclosure is not limited to such a separate configuration: the atomizer housing 3 and the controller housing 4 constituting the housing body 2 of this embodiment can also be formed as a single unit. However, such a configuration will not be discussed in more detail here.

[0076] The atomizer housing 3 houses the membrane unit 5, also known as the aerosol generator. The membrane unit 5 is configured to generate an aerosol from a liquid or fluid (i.e., a pharmaceutical agent). This will be explained in the reference below. Figure 2 and Figure 3 To describe in more detail.

[0077] 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 necessary to operate the inhalation therapy device 1 and monitor the treatment process.

[0078] Therefore, the controller housing 4 can be interpreted as a durable element that has lower cleaning and / or disinfection requirements compared to the atomizer housing 3. The atomizer housing can be configured as a disposable product or a product for use within a certain period of time, such as a certain number of treatments, weeks, or months.

[0079] 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 fixed at least temporarily by interlocking fasteners (not shown), and therefore it is also possible to reversibly attach and detach the nebulizer housing 3 from the controller housing 4 by means of said interlocking fasteners to facilitate cleaning of both parts of the housing body 2 and replacement of the nebulizer housing 3. The interlocking fasteners may also include magnetically interacting mating elements.

[0080] To achieve proper cleaning and / or disinfection of the atomizer housing 3 and easy access to the membrane unit 5 arranged inside the atomizer housing 3, from Figure 3 It is evident that a latch 6 is provided at the atomizer housing 3. The latch 6 allows access to the interior of the atomizer housing 3, particularly to the membrane unit 5 disposed therein. To date, Figure 1 The inhalation therapy device 1 is shown when the latch 6 holds the nebulizer housing 3 in the closed position, and Figure 3 The inhalation therapy device 1 is shown with the latch holding the nebulizer housing in the open position, allowing access ( Figure 3 (Not shown) Membrane unit 5. However, the latch 6 is not mandatory. A nebulizer housing 3 that cannot be opened by the user, operator, hospital staff or patient may also be provided, in which the membrane unit 5 is arranged in a fixed position and cannot be accessed / replaced.

[0081] In the given technical field, such a membrane unit 5 is typically referred to as a membrane unit or head unit. Similarly, the atomizer housing 3 is called a "nebset," which reflects the abbreviation for nebulization set.

[0082] A preferred embodiment is an inhalation therapy device 1 used by the user during treatment, through which they inhale and exhale. That is, the inhalation therapy device 1 contacts the user's mouth (preferably, mouth and nose) via a mask, for example, so that the user's regular inhalation and exhalation are performed by the inhalation therapy device 1. In other words, 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. Therefore, it goes without saying that such an inhalation therapy device can also be understood as an aerosol therapy device applied during the user's inhalation and exhalation.

[0083] The generation of aerosols inside the inhalation therapy device 1 and the actual aerosol therapy will now be described in more detail.

[0084] Figure 2The orientation of the inhalation therapy device 1 when held by a patient in an ideal position during treatment (i.e., in a seated position with the patient's head upright) is shown. 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 passing through the inhalation therapy device 1 along the flow path 8. In this respect, it is shown that the nebulizer housing 3 includes the flow path 8 passing through the nebulizer housing 3, and the membrane unit 5 is shown disposed in the flow path 8.

[0085] In the indicated location, a reservoir 9 for holding a liquid or fluid (i.e., a medication) is disposed in the upper section of the nebulizer housing 3. For filling with the liquid or fluid, the reservoir 9 of the inhalation therapy device 1 includes an opening 21. More specifically, the reservoir 9 includes a circumferential edge 27 that defines the reservoir 9 from the environment.

[0086] A cap 10, including a cap body 22, is disposed in the upper section of the reservoir 9, specifically on its circumferential edge 27, to ensure that fluid or liquid in the reservoir 9 does not spill during treatment. Until now, the circumferential edge 27 of the reservoir 9 has defined an opening 21 when the cap 10 is placed on the reservoir 9. Therefore, the cap 10 is configured to seal the opening 21 of the reservoir, for example, via threads that cause a reversible connection between the cap body 22 and the reservoir 9 disposed within the nebulizer housing 3.

[0087] In order to generate an aerosol for treatment, the membrane unit 5 is disposed in the housing body 2, particularly in the nebulizer housing 3, and even more particularly in the flow path 8 extending through the nebulizer housing 3.

[0088] Membrane unit 5 includes an aerosol generating membrane 11 and an actuator 12. Figure 3 In the diagram, membrane unit 5 is not shown for easier orientation.

[0089] exist Figure 2 In the cross-sectional view, the aerosol generating membrane 11 is arranged in an upright position (i.e., 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 first side 11.1 of the aerosol generating membrane 11 of the membrane unit 5 for generating an aerosol for user treatment. This is achieved by preferably arranging the aerosol generating membrane 11 at the lowest part of the reservoir 9 when the inhalation therapy device 1 is held by the user during treatment (see [link to relevant documentation]). Figure 2 ).

[0090] The aerosol generating membrane 11 includes a plurality of pores (not shown), and an actuator 12 is coupled to the aerosol generating membrane 11 such that the actuator can vibrate the aerosol generating membrane. In doing so, liquid passes through the pores and aerosol is generated on a second side 11.2 of the aerosol generating membrane 11 opposite to the first side 11.1. That is, aerosol agglomerates (also understood as "aerosol plumes") are formed within the membrane unit 5 inside the atomizer housing 3. Figure 2 It is generated in the left chamber.

[0091] Because the aerosol is generated on the second side 11.2 of the aerosol generating membrane 11, a negative pressure is established in the reservoir 9, which is closed by the cap 10. The more aerosol is generated, the more negative the pressure in the reservoir 9 becomes.

[0092] The negative pressure is desirable to ensure that the entire fluid is aerosolized through membrane unit 5. However, if the amount of negative pressure is established too high, i.e. becomes too strong (too negative), it may also be detrimental to aerosol formation, especially since this could lead to droplets that cannot be used as aerosols for treatment. Therefore, it is desirable to maintain the amount of negative pressure in reservoir 9 within a certain range.

[0093] Therefore, this embodiment includes a valve, specifically a one-way valve 23, which is disposed within the cover 10. The one-way valve 23 (which in an exemplary embodiment is formed as an umbrella valve (see example...) Figure 2 Figure 4a and Figure 4b The device is configured to open when the amount of negative pressure in reservoir 9 reaches a threshold during membrane vibration, and to close when the amount of negative pressure drops below the threshold, i.e., when the negative pressure decreases, it means that it becomes more positive (less negative).

[0094] Numerous experimental studies have demonstrated that optimal therapeutic outcomes and maximum TOR can be achieved by using valve opening and closing thresholds of -100 mbar or -200 mbar (a single value), depending on the liquid or fluid to be aerosolized. In this embodiment, the threshold for triggering the opening and therefore closing of the one-way valve 23 is set to -100 mbar. This prevents excessive negative pressure from being established in the reservoir 9 when aerosols are generated by vibrating the aerosol-generating membrane 11 via the actuator 12. Simultaneously, it allows maintaining a certain amount of negative pressure below the threshold during treatment to avoid any "leakage" effect on the second side 11.2 of the aerosol-generating membrane 11. As previously mentioned, the threshold may vary in practice, considering that the same device may operate under different environmental conditions or different devices in the same series may operate under the same conditions. Therefore, the actual value in practice may range from 50 mbar to 150 mbar or from 75 mbar to 125 mbar for the same device under different operating or environmental conditions or different devices in the same series may operate under the same conditions.

[0095] As previously described, the one-way valve 23 of the exemplary embodiment is configured as an umbrella valve.

[0096] As the name suggests, an umbrella valve, like an (at least partially) open umbrella protecting a user from rain or sun, is an elastomeric valve component. This elastomeric valve component includes a central rod and a radially extending convex diaphragm-shaped valve disc, which can also be understood as a sealing disc. This sealing disc acts as a counterpart to a check valve, abutting against the valve seat when the valve 23 is closed and held in the closed state. In this respect, from Figure 2 Figure 4a and Figure 4b It is evident that the cover body 22 serves as a valve seat in this configuration.

[0097] This elastomeric valve component (i.e., umbrella valve) serves as a sealing element acting as an anti-backflow device or a check valve / one-way valve, and thus can be understood as a venting valve, pressure relief valve, or metering valve that helps maintain the desired amount of negative pressure inside the reservoir 9 during treatment.

[0098] When the diaphragm of the umbrella valve abuts against the valve seat, it flattens out and absorbs a certain amount of valve seat irregularities, reliably generating a sealing force. Thus, once the head pressure generates sufficient force to lift the diaphragm from the valve seat, the umbrella valve can achieve forward flow. Therefore, the umbrella valve will allow unidirectional flow at a predetermined pressure and immediately prevent backflow in the opposite direction.

[0099] The main advantages of umbrella valves compared to other types of valves (such as spring-loaded disc valves) are that they utilize the properties of their elastic materials and their preloaded convex shape to generate a sealing force against the valve seat. Furthermore, umbrella valves use a central stem to hold components in place, thus eliminating the need for additional components such as springs, and for one or more central or circumferential disc positioners. This simplifies component design, allows the valve to fit within a minimal space, reduces the number of parts in the valve, simplifies valve assembly, and, last but not least, is highly cost-effective.

[0100] In other words, the one-way valve 23, configured as an umbrella valve, allows for simple, consistent, and reliable positioning with a simple configuration, and thus reliably opens and closes the valve 23 on the valve seat near a predetermined threshold. This interaction between the valve seat and the umbrella valve thus reliably and consistently maintains the desired amount of negative pressure inside the reservoir 9, thereby improving inhalation therapy.

[0101] exist Figure 2 Figure 4a and Figure 4bIn the exemplary embodiments shown, the one-way valve 23 is an umbrella valve of Minivalve International UM 070.006-141.01 or UM 070.006-171B.01, with a valve disc diameter of 7 mm and a total (stem) height of 4.5 mm. However, depending on, for example, given environmental conditions, the fluid or liquid to be used, and the selected inhalation therapy device configuration, other umbrella valves, or even different types of (one-way) valves, may be used.

[0102] Consistent with the above, Figure 5 A schematic diagram is provided, exemplarily illustrating the negative pressure curve inside the reservoir 9 of the inhalation therapy device 1 across a single administration interval.

[0103] Specifically, Figure 5 The pressure p, which is generally present inside the reservoir 9 sealed by the cap 10, is shown as negative pressure (underpressure), in millibars (mbar) on the y-axis, and the treatment time t is in seconds on the x-axis.

[0104] From the above Figure 5 It can be seen that for the first 10 seconds, the pressure inside the reservoir 9 is the ambient pressure, i.e., 0. This reflects the situation where the cover 10 has not yet closed the reservoir 9, for example, during the filling of the reservoir 9 with liquid or fluid.

[0105] Once the liquid or fluid is poured into reservoir 9, cap 10 is closed, and aerosol generation begins via actuator 12 to vibrate aerosol-generating membrane 11 after the first 10 seconds of treatment. This initiates negative pressure buildup within reservoir 9, creating a negative pressure within the reservoir. As previously described, valve 23 in cap 10 is configured to open when a threshold value of -100 mbar is met.

[0106] like Figure 5 As shown, due to the inertia of valve actuation, the negative pressure exceeds the negative pressure threshold very briefly, reaching a maximum of about 108 mbar. Figure 5 The pressure curve then continues with slight fluctuations (overflush and underflush), and ideally, during further stages of the dosing interval, it tends to stabilize at 110 seconds of treatment (out of a total of 120 seconds) due to the operation of the valve (i.e., opening and closing) and the aforementioned configuration of the valve. Therefore, the amount of negative pressure inside reservoir 9 can be maintained at / around a certain negative pressure level (here, -100 mbar).

[0107] Figure 5It was also shown that the internal pressure of reservoir 9 dropped slightly from about 102 mbar to 96 mbar after 120 seconds. This is due to the fact that after 120 seconds, i.e., 110 seconds after aerosol generation, the amount of the exemplary fluid or liquid (here, NaCl) used was almost entirely aerosolized, so that the pores of the membrane on the first side 11.1 of the membrane were no longer completely covered by liquid, and air could pass through the pores.

[0108] To prevent the positive effects of aerosol generation caused by the controlled negative pressure range inside the reservoir 9 due to the configuration of the one-way valve 23 in the cover 10 from being obtained only after the negative pressure has been established to a sufficient level after aerosol generation has begun, the inhalation therapy device 1 also includes a negative pressure generating device.

[0109] The negative pressure generating device is configured to generate an initial negative pressure in the reservoir 9 before the aerosol generating membrane 11 vibrates and thus generates aerosols. In other words, the negative pressure generating device allows aerosol generation to begin in the presence of negative pressure in the reservoir 9. Therefore, improved aerosol generation can be achieved from the very first moment the aerosol generating membrane 11 is vibrated, without the aforementioned risk of "leaking" aerosols through the pores of the aerosol generating membrane 11 without being aerosolized.

[0110] In order to generate the initial negative pressure in the reservoir 9 before the aerosol generating membrane 11 vibrates, from Figure 2 Figure 4a and Figure 4b It is obvious that the negative pressure generating device includes an annular seal 24 and a moving member 25. In this regard, Figures 4a and 4a show... Figure 4b The cover 10 of the inhalation therapy device, the valve 23 of the cover, and the initial negative pressure generating device arranged in the cover are shown. For easier orientation, Figures 4a and 4b are shown. Figure 4b The circumferential edge 27 of the reservoir 9 and the rest of the atomizer housing 3 are not shown.

[0111] The annular seal 24 includes an outer circumferential portion 26 and an inner circumferential portion 28.

[0112] The outer circumferential portion 26 of the annular seal 24 is sandwiched between the cap body 22 of the cap 10 and the circumferential edge 27 of the reservoir 9, thus defining and sealing the cap 10 to the environment in the area of ​​the opening 21. In other words, during treatment, the outer circumferential portion 26 of the annular seal 24 seals the contact area between the circumferential edge 27 of the reservoir 9 and the cap body 22. Therefore, any leakage of fluid or liquid in the contact area between the cap body 22 and the reservoir 9 can be reliably prevented.

[0113] The opposing inner circumferential portions 28 of the annular seal 24 are attached to the movable member 25. Thus, the annular seal 24 interconnects and seals the area between the cap body 22 and the movable member 25 in a flexible and movable manner. In other words, even when the position of the movable member 25 changes to generate an initial negative pressure (which will be described in more detail below), the reservoir 9 can be reliably sealed to the environment via the cap 10 and the annular seal 24.

[0114] In the illustrated embodiment, the movable member 25 forms the central portion of the negative pressure generating device. However, this embodiment is not limited to such a central arrangement of the negative pressure generating device within the cover 10.

[0115] To generate an initial negative pressure via the negative pressure generating device, the moving member 25 is configured to move the inner circumferential portion 28 of the annular seal 24 away from the aerosol generating film 11, particularly away from the first side 11.1 of the aerosol generating film 11, when the cap body 22 is fastened to the reservoir 9. That is, this configuration of the moving member 25 and the resulting movement away from the aerosol generating film 11 allow for an increase in the sealed volume of liquid or fluid and air interlocked and sealed in the reservoir 9 via the interconnected caps 10, and by this movement, a negative pressure is generated even when the actuator 12 is not operated. Figure 2 In the diagram, arrow D indicates an exemplary direction of movement D of the inner circumferential portion 28 of the annular seal 24 when the cap body 22 is fastened to the reservoir 9 to generate an initial negative pressure. It is evident that the moving member 25 moves the inner circumferential portion 28 of the annular seal 24 toward the upper side of the inhalation therapy device 1, away from the nebulizer housing 3.

[0116] Already from the applicant's previous application EP4249022A1 Figure 3 A and Figure 3 B and the corresponding descriptive paragraphs are known, and the operating mechanism of the negative pressure generating device that allows the initial negative pressure to be generated inside the reservoir 9 before the membrane unit 5 begins operation is hereby incorporated by reference.

[0117] For completeness, the operation of the negative pressure generating device is shown in Figure 4a and Figure 4a of this disclosure. Figure 4b A brief explanation of the cross-sectional view is provided.

[0118] The movable component 25 is movably linked to the cover body 22 via an annular seal 24. (See Figure 4a and...) Figure 4bAs shown, the movable member 25 is connected to the inner circumferential portion 28 of the annular seal 24, and the outer circumferential portion 26 of the annular seal 24 is tightly pressed between the circumferential edge 27 of the reservoir 9 and the cap body 22. In other words, due to the threaded connection between the circumferential edge 27 and the cap body 22, the annular seal 24 is clamped / tightened between the circumferential edge 27 of the reservoir 9 and the cap body 22. Therefore, the opening 21 can be sealed to the environment.

[0119] Regarding the generation of negative pressure via the negative pressure generating device, Figure 4a shows the movable member 25 at position 1. Figure 4b The movable member 25 is shown in position 2. A comparison of these two positions clearly shows that when the cap body 22 is attached to the atomizer housing 3, the movable member 25 moves with the annular seal 24 from position 1 in FIG. 4a to position 2 in FIG. 4a, where a negative pressure can be generated in the reservoir 9. This is achieved because the movable member 25 and the cap body 22 also engage threadedly via the negative pressure through the threads 29. Since the movable member 25 cannot rotate with the cap 10 once the annular seal 24 is clamped between the circumferential edge 27 and the cap body 22, the rotation of the cap 10 is converted from position 1 in FIG. 4a to... Figure 4b The translational movement of position 2 in the membrane generates an (initial) negative pressure even if the membrane unit is not operated.

[0120] The one-way valve 23 is arranged in the moving member 25, and thus moves together with the moving member 25 and the inner circumferential portion 28 of the annular seal 24 when the cap body 22 is fastened to the reservoir 9.

[0121] In addition, from Figure 2 It is evident that, in order to carry 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.

[0122] The flow path 8 includes a first opening 7 at one end of the atomizer housing 3 leading to the housing body 2, particularly the outside of the atomizer housing, and a second opening 13 at the other end of the atomizer housing 3 leading to the housing body 2, particularly the outside of the atomizer housing 3.

[0123] 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 it is also possible, for example, that the position of the second opening 13 is arranged off-center from the longitudinal axis passing through the first opening 7 of the flow path 8.

[0124] As previously stated, the first opening 7 is to be brought into contact with the user’s airway directly or indirectly (e.g., via a mouthpiece or mask) through his or her mouth and optionally his or her nose, so that during aerosol therapy, inhalation and exhalation can be achieved through the flow path 8 of the inhalation therapy device 1.

[0125] Conversely, the second opening 13 allows air to enter and exit the flow path 8. Therefore, the flow path 8 and the first opening 7 and second opening 13 leading to the outside of the nebulizer housing 3 enable a flow to be generated in the flow path 8 along 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, wherein 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 channel 15 (described in more detail below) and the membrane unit 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.

[0126] In example Figure 2 In the embodiment shown, when the user exhales into the flow path 8 at the first opening 7, the entire flow volume along the second flow direction B (i.e., the direction of the exhaled airflow from the first opening 7 to the second opening 13) also passes through the second opening 13.

[0127] Figure 2 The first flow direction A (i.e., the direction of the inhalation flow) from the second opening 13 to the first opening 7 is shown, and the second flow direction B (i.e., the direction of the exhalation flow) from the first opening 7 to the second opening 13 is shown.

[0128] Regarding the shape of flow path 8, from Figure 2 It is evident that the flow path 8 is shaped to prevent air from flowing directly (unredirected) from the second opening 13 to the first opening 7 of the flow path 8, and vice versa. This exemplary flow through the flow path 8 in the atomizer housing 3 is caused by... Figure 2 Line C is shown in the diagram. From... Figure 2 It is evident that the center point of the cross section of the first opening 7, the center point of the cross section of the membrane unit 5, and the center point of the cross section of the second opening 13 are not aligned on a single axis, thereby causing the air to be redirected through the inhalation therapy device 1, and thus omitting the tubular flow path structure.

[0129] The membrane unit 5 is arranged in the flow path 8 in such a way that the membrane unit can be surrounded by the flow passing through the flow path 8, and thus in the flow that can be generated by the user's breathing, particularly his or her inhalation and exhalation. As shown, the membrane unit 5 is arranged in a centrally located position in the axial and circumferential directions of the flow path 8 such that when the user breathes through the inhalation therapy device 1 during treatment, the sheathing enveloping flow can pass through the entire membrane unit 5 in the flow path 8 during inhalation or exhalation.

[0130] The line C extending from the second opening 13 to the first opening 7 represents an exemplary flow of air along the first flow direction A (i.e., the intake (air) flow). However, it should be understood that this exemplary flow path 8 is not limited to the flow passing through the lowest point of the flow path 8 below the membrane unit 5. This is merely one example of the flow shown in a cross-sectional view through the flow path 8. In reality, the flow passes through the membrane unit 5 and the reservoir 9, which is also shown, for example, on the side of the membrane unit 5, because it is arranged in such a way that an envelope flow is generated around the circumference of the membrane unit 5.

[0131] It is precisely the airflow that is redirected to be directed around membrane unit 5 in order to entrain and transport the generated aerosol upon inhalation.

[0132] To trigger the actuator 12 of membrane unit 5 and assess the quality of inhalation therapy, it is necessary to observe the manner of inhalation and exhalation performed by inhalation therapy device 1. To date, preferred embodiments have provided an easily manufactured and sterilizable scheme that reliably monitors / measures the pressure and negative pressure within the flow path 8 during inhalation and exhalation as flow parameters within the flow path 8.

[0133] For this purpose, the inhalation therapy device 1 includes a sensor 14 configured to detect the pressure value inside the flow path 8.

[0134] from Figure 3 The exploded isometric view of the inhalation therapy device 1 clearly shows that the controller housing 4, in addition to housing the controller, also houses the sensor 14. The controller is configured to control the membrane unit 5, that is, 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.

[0135] To provide observation of pressure values ​​in the flow path 8 via sensor 14, the inhalation therapy device 1 includes a measurement channel 15 connecting the flow path 8 and sensor 14. Given 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 channel 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 channel 15 has a circular shape, and the central axes of the portions 15.1 in the nebulizer housing 3 and 15.2 in the controller housing 4 are aligned with each other, such that the portions 15.1 in the nebulizer housing 3 and 15.2 in the controller housing 4 form a single cylindrical channel, hose, or conduit, etc., which interconnects the flow path 8 and sensor 14 without disrupting the smooth flow transmission (mitigation) in the measurement channel 15 due to turbulence or other disturbances. Therefore, the pressure generated by the patient's inhalation and exhalation can be smoothly transmitted through the flow path 8 and the measurement channel 15 for detection by the sensor 14.

[0136] When viewed along the direction of the inhalation flow A, the connection between the measuring channel 15, particularly portion 15.1 of the measuring channel 15 in the atomizer housing 3, and the flow path 8 is located upstream of the membrane unit 5 in the flow path 8. To illustrate this, in Figure 3 In the open state of the atomizer housing 3 shown, the membrane unit 5 is hidden.

[0137] like Figure 2 and Figure 3 As shown, the arrangement of the measurement channel 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 the ambient pressure (i.e., a reference pressure, which can also be understood as ambient pressure). To detect the ambient pressure, the controller housing 4 may additionally include a hose 16 extending through the controller housing 4, which enables the detection of the ambient pressure and comparison of that ambient pressure with the pressure in the flow path 8 via the differential pressure sensor 14.

[0138] In an exemplary embodiment, when viewed along the first flow direction A, not only the measuring channel 15, but also the second opening 13 of the flow path 8 is arranged upstream of the membrane unit 5. In this respect, from Figure 2 It is evident that the second opening 13 is located in the upper half of the atomizer housing 3.

[0139] In addition, from Figure 2As can be seen from the cross-sectional view, when viewed along the first flow direction A, the measuring channel 15 is essentially positioned in the middle of the flow path 8 between the membrane unit 5 and the second opening 13. However, this arrangement is not particularly restrictive, and it is also possible to arrange the interconnection between the measuring channel 15 and the flow path 8 closer to the second opening 13 in the flow path 8 than the membrane unit 5, or even to arrange the measuring channel 15 closer to the membrane unit 5 in the flow path 8 than the second opening 13.

[0140] To protect the sensor 14 from liquids, aerosols (droplets), or phlegm in the best possible way, 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 separated from each other, the inhalation therapy device 1 includes two pressure-transmitting membranes 17 and 18. One pressure-transmitting membrane 17 seals / encloses / seals portion 15.1 of the measurement channel 15 in the nebulizer housing 3, while the other pressure-transmitting membrane 18 seals / encloses / seals portion 15.2 of the measurement channel 15 in the controller housing 4.

[0141] In order to keep any pressure loss as low as possible when the pressure is smoothly transmitted through the flow path 8 and through the measurement channel 15 toward the sensor 14, pressure transmission membranes 17 and 18 are respectively configured to transmit the pressure in the flow path 8 to the sensor 14, wherein the pressure transmission membrane 17 arranged in the atomizer housing 3 is impermeable to liquid, while the pressure transmission membrane 18 arranged in the controller housing 4 is impermeable to both liquid and air.

[0142] from Figure 3 It is evident that the sensor 14 in the controller housing 4 does not directly contact the pressure transmission membrane 18, which encloses the portion 15.2 of the measurement channel 15 in the controller housing 4 between the sensor 14 and the pressure transmission membrane 18. Instead, the pressure transmission membrane 18 and the sensor 14 are spaced apart from each other. The volume of the portion of the measurement channel 15 created by this distance is filled with gel to eliminate pressure loss that may be caused by a compressible medium, such as air, which would fill the volume if the gel were not present.

[0143] The second opening 13 can be shaped in such a way that it can be considered a flow restrictor. To achieve flow resistance, a geometry is created that causes higher flow resistance in the inhalation flow direction than in the expiratory flow direction. Typical relationships between inhalation and expiratory 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 expiratory flow resistance established by the shape of the second opening is 190%. This allows for advantageously prolonged inhalation time while potentially shortening expiratory time.

[0144] Now refer to Figure 2 The actual shape of the second opening 13, which is responsible for treating the second opening as the aforementioned flow restrictor, is described in more detail.

[0145] For this purpose, the second opening 13 of the flow path is shaped as a fixed geometric passive valve. 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 to deliver the generated aerosol to the user during treatment.

[0146] from Figure 2 It 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 allows the flow resistance in the second flow direction B to be lower than the flow resistance in the first flow direction A, without requiring any active components, such as an actuation valve.

[0147] In another embodiment, it is also possible to provide a third opening 19 in the flow path 8 between the first opening 7 and the second opening 13, leading to the outside of the atomizer housing 3.

[0148] This is for example in Figure 1 As shown, when viewed along the first flow direction A, the third opening 19 is arranged upstream of the membrane unit 5. Furthermore, the third opening 19 is provided with a one-way valve 20, which is configured to restrict flow through the third opening 19 along the first flow direction A. That is, the one-way valve 20 of the third opening 19 prohibits any flow through the third opening 19 during intake. However, the one-way valve 20 of the third opening 19 is also configured to allow flow from the first opening 7 to the second opening 13 through the third opening 19 along the second flow direction B, so that air can be at least partially, preferably substantially completely, discharged through the third opening 19.

[0149] This configuration allows for the desired inhalation flow resistance to be achieved, while also allowing for a further reduction in expiratory flow resistance, because the one-way valve 20 of the third opening 19 facilitates the expulsion of air via the one-way valve 20 of the third opening 19 and the third opening 19 of the flow path 8.

[0150] Regardless of the presence of the third opening 19, in another embodiment (not shown), the inhalation therapy device 1 may include an air filter device reversibly attachable and detachable to the nebulizer housing 3. The air filter device 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. Assuming the presence of the third opening 19, the air filter device is shaped to cover the third opening 19 and a one-way valve 20, such that during exhalation, the flow in the second flow direction B primarily passes through the air filter device to 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 device is shaped to cover the second opening 13 (which, besides the first opening 7, is the only opening in the flow path 8 leading 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 device, and during exhalation, the entire flow volume along the second flow direction B passes through the air filter device.

[0151] Reference number list 1. Inhalation therapy device 2. Shell body 3. Atomizer housing 4. Controller housing 5 membrane units 6. Latch 7. The first opening in the flow path 8 Flow path 9. Liquid reservoir 10 lids 11 Aerosol Formation Membrane 11.1 The first side of the aerosol-forming membrane 11.2 The second side of the aerosol-forming membrane 12 Actuators 13. The second opening in the flow path 14. Sensor (Pressure Sensor) 15 Measurement Channels 15.1 Measurement channel portion within the atomizer housing 15.2 Measurement channel portion within the controller housing 16 Hose 17. Pressure transmission membrane in the atomizer housing 18. Pressure transmission diaphragm in the controller housing 19 Third Opening 20. One-way valve with third opening 21. Opening of the reservoir 22 Cover body 23 (One-way) Valve 24 Annular seal 25 Moving components 26. Outer circumference of the annular seal 27. The circumferential edge of the reservoir 28. Inner circumferential portion of an annular seal. 29. Negative pressure generates threads A. First flow direction (inhalation flow direction) B. Second flow direction (exhalation flow direction) C. An exemplary flow through the flow path. D. Direction of movement of the inner circumferential portion of the annular seal caused by the moving component.

Claims

1. An inhalation therapy device (1), comprising: Shell body (2); Liquid reservoir (9), the liquid reservoir being used to hold liquid; Membrane unit (5), the membrane unit comprising: An aerosol generating membrane (11) is disposed in the housing body (2) and has a plurality of pores, wherein the aerosol generating membrane (11) is configured such that, when liquid is held in the reservoir (9), the liquid is supplied by gravity to a first side (11.1) of the aerosol generating membrane (11); and An actuator (12) is coupled to the aerosol generating membrane (11) for vibrating the aerosol generating membrane (11), thereby allowing the liquid to pass through the plurality of holes and generate an aerosol on the second side (11.2) of the aerosol generating membrane (11) opposite to the first side (11.1), and establishing a negative pressure in the reservoir (9); The valve (23) is configured to open when the amount of negative pressure in the reservoir (9) reaches a threshold during use of the inhalation therapy device (1), preferably when the aerosol generating membrane (11) vibrates, and to close when the amount of negative pressure drops below the threshold.

2. The inhalation therapy device (1) according to claim 1, wherein, The valve is a one-way valve (23).

3. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The threshold for the amount of negative pressure is a single value in the range of 20 mbar to 400 mbar, such as 100 mbar or 200 mbar.

4. The inhalation therapy device (1) according to any one of the preceding claims, wherein, The inhalation therapy device (1) also includes a cap (10) for sealing the opening (21) of the reservoir (9).

5. The inhalation therapy device (1) according to claim 4, wherein, The valve (23) is arranged in the cover (10).

6. The inhalation therapy device (1) according to claim 4 or 5, wherein, The cover (10) also includes a negative pressure generating device for generating an initial negative pressure in the reservoir (9) before the inhalation therapy device (1) is used, preferably before the aerosol generating membrane (11) is vibrated.

7. The inhalation therapy device (1) according to claim 6, wherein... The cover (10) includes a cover body (22), and The negative pressure generating device includes: An annular seal (24) is clamped at its outer circumferential portion (26) between the cap body (22) and the circumferential edge (27) of the reservoir (9) defining the opening (21) when the cap (10) is placed on the reservoir (9). A movable member (25) is attached to the inner circumferential portion (28) of the annular seal (24), the movable member (25) being configured to move the inner circumferential portion (28) of the annular seal (24) away from the aerosol generating film (11) when the cap body (22) is fastened to the reservoir (9) to generate the initial negative pressure.

8. The inhalation therapy device (1) according to claim 7, wherein, The valve (23) is arranged in the moving member (25).

Images