Inhalation treatment device

Abstract

An inhalation treatment device comprises a housing body (4), a reservoir (2), a membrane unit comprising a membrane (5), an actuator (6) and a flow path (7). A liquid is supplied to the first side of the membrane, and an aerosol is generated at the second side. A flow is created in a first flow direction from the second opening to the first opening of the flow path upon inhalation and a flow is created in a second flow direction from the first opening to the second opening upon exhalation. The second opening is shaped to establish a flow resistance of 160 Pa + / -100 Pa upon inhalation of the user, and the flow resistance upon exhalation is at least 25% lower than the flow resistance upon inhalation, the flow resistance measured at peak flow rates of sinus breathing modes with inhalation and exhalation times of two seconds, respectively, and tidal volume of 500 ml.

Description

TECHNICAL FIELD

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

[0002] Inhalation therapy devices, also referred to as (inhalation) nebulizers or aerosol delivery devices, are widely used for delivering a therapeutically effective amount of a medicament, such as a drug and a vaccine, to a user in the form of an aerosol through the user’s respiratory system. Inhalation therapy devices can also be used for diagnostic purposes, using radioisotopes for lung challenge tests. For therapy, aerosol inhalation is the preferred route of administration for some drugs, which can be used to treat systemic or respiratory diseases.

[0003] To achieve the intended therapy, the aerosol particles have to be deposited at a specific site of the respiratory tract of the user’s body, 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 having a MMAD (mass median aerodynamic diameter) of less than 5 pm or even less than 4 pm and at least 1 pm are required to allow deposition in the intended part of the respiratory system.

[0004] Using an inhalation therapy device, an aerosol for therapeutic purposes is generated and delivered into the user’s body, in particular into his or her respiratory tract. To this end, a fluid or liquid to be aerosolized or nebulized, i.e. a medicament, a drug, a vaccine, etc., is supplied to a reservoir for holding the fluid or liquid in the inhalation therapy device. To aerosolize or nebulize the liquid in the reservoir, the inhalation therapy device can comprise, for example, a membrane unit.

[0005] Such a membrane unit comprises a membrane having a plurality of orifices and an actuator coupled to the membrane, directly or indirectly via a support plate supporting the membrane, to vibrate the membrane.

[0006] The fluid or liquid can be brought into contact with a first side of the membrane by gravity. The fluid or liquid, i.e. the drug, passes through the orifices from the first side of the membrane and generates an aerosol on a second side of the membrane opposite the first side of the membrane when the membrane is vibrated.

[0007] The aerosolized or nebulized fluid or liquid, i.e. the aerosol, within the inhalation therapy device is then supplied to the user’s respiratory system in the context of the inhalation therapy when the user inhales through the inhalation therapy device. This means that, when the user applies a suction force by breathing, in particular his or her inhalation, through the inhalation therapy device, the aerosol is at least partially (by the suction force) delivered from the interior of the inhalation therapy device to the user’s respiratory tract.

[0008] An example of a conventional inhalation therapy device with such a configuration can be derived, for example, from DE 199 53 317 C1. The membrane unit of the disclosed inhalation therapy device comprises a cylindrical liquid reservoir which is delimited at one end face by a membrane having a disc shape. The side of the liquid-contacting membrane facing the liquid reservoir is provided in the liquid reservoir.

[0009] DE 199 53 317 C1 also discloses a membrane which is connected (welded) to a base plate (support plate) and an oscillation generator, for example a piezoelectric crystal, which surrounds the membrane in a circular manner and is connected (glued) to the base plate, so that the membrane can be oscillated by the oscillation generator and an electrical drive circuit.

[0010] The liquid on the membrane applied to the first side of the membrane is thus conveyed through the orifice in the oscillating membrane to the second side of the membrane opposite the first side of the membrane to the chamber in the form of an aerosol. The disclosed inhalation therapy device also comprises a mouthpiece or face mask connected to the outlet of the chamber and having an exhalation valve. Thus, when the user exhales, the exhalation airflow will not or only to a limited extent enter the chamber, but will be discharged through the exhalation valve to the environment of the device.

[0011] The disclosed device continuously drives the piezoelectric crystal over the entire (single) treatment time (single dosing interval), wherein substantially the entire liquid in the liquid reservoir is aerosolized by the membrane. During exhalation by the user, the generated aerosol is temporarily stored in the chamber, forming an aerosol cloud which, when inhaled, is inhaled and transported to the respiratory tract of the user for treatment. Thus, the treatment time can be kept relatively short.

[0012] However, one potential disadvantage is that with increasing output rate of the aerosol generator (membrane, piezoelectric crystal, drive circuit, etc.), the deposition on the inner walls of the device (referred to as so-called "deposits") increases, in particular the amount of aerosol in the chamber. This leads to an increased loss of administrable aerosol / drug.

[0013] Other conventionally known inhalation therapy devices drive the piezoelectric crystal only during inhalation and stop driving the piezoelectric crystal during exhalation. Those inhalation therapy devices are often referred to as breath-triggered devices or breath-actuated devices. It has been found that such inhalation therapy devices often suffer from a long treatment time, i.e. a long treatment duration (long dosing interval), which can be annoying for the user, leading to a lack of compliance of the user, for example, that the treatment is interrupted or ended prematurely before the intended dose of fluid or liquid in the liquid reservoir is aerosolized and delivered to the respiratory tract of the user for treatment.

[0014] The two conventional inhalation therapy devices described above are typically operated in such a way that the user only inhales through the inhalation therapy device (an inhalation flow is generated through the fluid path of the device) and removes the inhalation therapy device from the user's mouth and / or nose upon exhalation. While both are able to achieve unobstructed exhalation of the user, the entire therapy cannot be satisfactorily monitored because data such as flow parameters in the flow path of the device cannot be obtained during exhalation. Moreover, in the case of continuous operation, the generated aerosol is lost without any therapeutic effect on the user.

[0015] Most importantly, the removal of the inhalation therapy device upon each exhalation negatively impacts the "natural" breathing of the user (i.e. his or her steady breathing cycle).

[0016] Therefore, there is still a need for a simple and effective inhalation therapy device which enables a short total therapy / therapy time (single dosing interval).

[0017] In some cases, the single dosing interval can comprise at least five breathing cycles, which include five inhalations and five exhalations, and use at least 0.25 mL of fluid or liquid. In other cases, the single dosing interval can comprise at least ten breathing cycles, which include ten inhalations and ten exhalations, and use at least 0.5 mL of fluid or liquid. SUMMARY

[0018] In view of the foregoing, it is an object of the present disclosure to establish an inhalation therapy device which improves the overall quality of drug delivery while keeping the total therapy time as short as possible.

[0019] This object is solved by an inhalation therapy device according to independent claim 1. Different embodiments can be derived from the dependent claims.

[0020] According to a first aspect of the present disclosure, the inhalation therapy device comprises a housing body, a reservoir for holding a liquid, a membrane unit and a flow path.

[0021] The membrane unit is arranged inside the housing body and comprises a membrane which is arranged in the housing body in such a way that the liquid is supplied to a first side of the membrane when a fluid or liquid to be aerosolized or aerosolized (i.e. a drug) is held in the reservoir of the inhalation therapy device.

[0022] The membrane unit further comprises an actuator which is coupled to the membrane, directly or indirectly via a support plate supporting the membrane, for vibrating the membrane. For generating an aerosol, the membrane comprises a plurality of orifices, wherein upon vibration of the membrane, the liquid passes through said orifices and an aerosol is generated at a second side of the membrane, the second side of the membrane being opposite to the first side of the membrane.

[0023] The fluidic path itself is defined in the housing body and comprises a first opening at one end of the fluidic path leading to the outside of the housing body (ambient) and a second opening at the other end leading to the outside of the housing body.

[0024] The membrane unit is arranged in the flow path between the first and second openings. This configuration is not limited to an in-line arrangement of the membrane unit in the flow path itself. For example, the membrane unit can also be arranged in a separate channel in fluid communication with the flow path, such that the generated aerosol can likewise be transmitted to the flow path. One example of such a configuration is a T-connection inside the flow path. At the same time, the membrane unit can be arranged directly / in-line in the fluidic path in such a way that it can at least partially be surrounded by the flow in the fluidic path. In other words, an envelope flow is generated around the circumference or a portion of the circumference of the membrane.

[0025] Thus, when the user inhales at the first opening, a flow in the fluidic path can be generated from the second opening to the first opening in at least the first flow direction to entrain and deliver the aerosol generated at the second side of the membrane inside the fluidic path to the user or patient.

[0026] The "first opening" can for example be understood as a "mouthpiece", an inhalation mask, etc., or at least a connection to such an element through which the user can apply a suction to the flow path of the inhalation therapy device.

[0027] Thus, in order to establish said flow through the fluidic path in the first flow direction, air must accordingly be able to enter the flow path at the second opening. Thus, when the user inhales at the first opening of the therapy device, the "second opening" at least serves as an "entrance" for air to entrain and deliver the generated aerosol inside the inhalation therapy device. The second opening can thus also be referred to as an "entrance opening" in the first flow direction and the first opening can thus also be referred to as an "exit opening" in the first flow direction during the inhalation phase.

[0028] In view of the above, the first flow direction can be interpreted as the "inhalation direction" of the (air) flow through the inhalation therapy device.

[0029] When the user or patient exhales into the fluidic path at the first opening to expel air from the user's airways, a flow in the second flow direction can also be generated in the fluidic path, opposite from the first opening to the second opening. Thus, the second flow direction can be interpreted as the "exhalation direction" of the (air) flow through the inhalation therapy device. The second opening can thus also be referred to as an "exit opening" and the first opening can thus also be referred to as an "entrance opening" during the exhalation phase.

[0030] This allows the inhalation therapy device to remain in contact with the user (e.g. his or her mouth, and thus his or her respiratory tract) during the entire treatment duration (treatment time) of a single dosing interval, and inhalation and exhalation can take place through the airflow of the inhalation therapy device.

[0031] According to a first aspect, the second opening of the inhalation therapy device is shaped to act as a flow resistor.

[0032] To this end, the second opening is shaped in such a way that it establishes a flow resistance of 160 Pa ± 100 Pa at inhalation by the user, and a flow resistance that is at least 25% lower than the flow resistance at inhalation at exhalation, measured at a peak flow of a sinusoidal breathing pattern with an inhalation time and an exhalation time of two seconds each and a tidal volume of 500 ml.

[0033] Preferably, the flow resistance at inhalation by the user resulting from the shape of the second opening is in the range of 160 Pa ± 60 Pa.

[0034] More preferably, the flow resistance at inhalation by the user resulting from the shape of the second opening is in the range of 160 Pa ± 30 Pa.

[0035] Thus, the “flow resistance at inhalation” can also be understood as the “inhalation resistance” (or “pressure loss”) that the user has to overcome to breathe when performing inhalation through the inhalation therapy device. Thus, this can also be understood as the negative pressure inside the inhalation therapy device established via the shape of the second opening of the flow path of the inhalation therapy device. Similarly, the “flow resistance at exhalation” can also be understood as the “exhalation resistance”.

[0036] The “peak air flow” of a breathing pattern is a standardized way of evaluating air flow of anesthetic and breathing equipment, such as nebulization systems and components thereof. To this end, it is common practice to apply the sinusoidal breathing pattern with an inhalation time and an exhalation time of two seconds each and a tidal volume of 500 ml at the anesthetic and breathing equipment to establish comparative information between such anesthetic and breathing equipment. Details on how to detect / measure these peak air flow values, the equipment required to do so, and the experimental conditions are for example reflected in the “DIN Committee for Standards in Rescue Services and Hospitals” standard DIN ISO 27427.

[0037] This international standard aims to cover “general purpose” inhalation therapy devices and is based on adult test parameters for evaluating the suitability of individual inhalation therapy devices disclosed by manufacturers, and for evaluating their safety as well as the compatibility between the materials of the inhalation therapy device components and the dispensed liquid.

[0038] The flow resistance is essentially controlled by the second opening used as a flow restrictor only. This is because all cross sections within the flow path inside the inhalation therapy device are typically significantly higher than (at least) the cross section of the second opening used as a flow restrictor at the time of inhalation by the user. It is therefore reasonable to assume that the second opening acting as a flow restrictor is responsible for almost 100% of the flow resistance, i.e. the entire flow resistance inside the inhalation therapy device, because the potential hydrodynamic effects of the other cross sections within the flow path of the inhalation therapy device are (typically) negligible due to the larger cross section of the second opening.

[0039] Based on the above-mentioned standard DIN ISO 27427 and based on the fact that all remaining (flow) cross sections in the device other than the second opening (used as a flow restrictor) are sufficiently large so that the absolute dynamic pressure is not greater than the inhalation resistance, it is reasonable to assume that, during the application of the standard (experimental) sinusoidal breathing pattern (inhalation and exhalation times of two seconds each, tidal volume of 500 ml) to the inhalation therapy device, at the above-mentioned "peak flow", which is the maximum absolute pressure value detected inside the inhalation therapy device during said application of the sinusoidal breathing pattern.

[0040] This peak flow therefore corresponds to a flow rate of 23.56 l / min through the inhalation therapy device and the pressure value inside the inhalation therapy device when applying the above-mentioned breathing pattern can be determined using the standard setup of a differential pressure sensor having one sensor port located inside the device (measuring the static pressure) and one sensor port located in the environment (measuring the reference pressure), thereby determining the flow resistance.

[0041] In this respect, conventional inhalation therapy devices either only achieve similar inhalation and exhalation flow resistances or require more complex arrangements with additional structural elements to shorten the single dosing interval. Having an increased but identical flow resistance in the inhalation and exhalation direction through the inhalation therapy device negatively affects inhalation due to increased breathing effort, faster exhalation or breathing difficulties and a comparably short inhalation time, while also negatively affecting exhalation due to an undesired prolonged exhalation time against a significant exhalation resistance.

[0042] While a prolonged exhalation time and / or a significant exhalation resistance often leads to an undesired feeling of the user due to the resistance against the exhalation, a comparably short inhalation time negatively affects the therapy efficiency in the respiratory tract of the user.

[0043] The present disclosure therefore proposes to provide a second opening used as a flow restrictor configured to establish the above-mentioned flow resistance at the time of inhalation by the user to achieve an inhalation therapy device which on the one hand can prolong the inhalation time while keeping the exhalation resistance low, thereby shortening the exhalation time due to the reduced "exhalation resistance".

[0044] Simultaneously increasing the inhalation resistance and decreasing the exhalation resistance provides four main advantages:

[0045] i) The maximum flow rate during inhalation is limited due to the increased breathing resistance (caused by the second opening used as a flow restrictor) resulting in a higher drug deposition in the lungs. Thus, the amount of drug deposition in the user's lungs can be increased which allows to reduce the amount of drug compound that needs to be aerosolized for the treatment. Ultimately, this enables a shorter overall treatment time.

[0046] ii) The duration of inhalation is prolonged resulting in a longer (time) window in which the aerosol can be generated and ultimately in a shorter treatment duration.

[0047] iii) When inhalation is prolonged due to the increased breathing resistance, exhalation is shortened due to the decreased breathing resistance. This reduces the breathing effort as the user is able to maintain the breathing frequency and the minute ventilation.

[0048] iiii) The inhalation pressure signal usually plays a more important role in opening the membrane unit (i.e. the aerosolization unit). The increased absolute pressure during inhalation by the inventive shape of the second opening facilitates the triggering and results in an improved treatment, in particular an improved reliability and a shorter treatment duration.

[0049] In other words, the prolonged inhalation time caused by the above inhalation resistance range advantageously influences the treatment success as a longer and slower (in terms of flow rate) inhalation by the user through the inhalation device can be achieved so that the aerosolized liquid (i.e. the drug) can be supplied to the user's respiratory tract in an improved way. This is because the delivery dose rate (per inhalation and inhalation treatment) can be increased.

[0050] The inhalation treatment device is also capable of being continuously held on the user's mouth and / or nose during the treatment (single dosing interval) and both inhalation and exhalation are conducted through the fluid path of the inhalation treatment device.

[0051] It should also not be neglected that having a flow restrictor directly at the opening of the flow path (here the second opening) leads to an improved cleanability and sterilization of the inhalation treatment device. This is because a flow restrictor arranged between the first opening and the second opening can cause an increased contamination in the resulting undercuts. This is the case because such a flow restrictor will hydraulically and of course also geometrically divide one large cavity into two smaller cavities while causing said undercuts.

[0052] According to a second aspect, the inhalation treatment device additionally comprises a sensor. The sensor comprises a measurement port arranged in the flow path. The sensor is configured to detect a flow parameter of the flow in the flow path via the measurement port.

[0053] In its preferred configuration, the detected or measured "flow parameter" is a pressure value, a volume flow, etc.

[0054] Any of these flow parameters can be used to trigger aerosol generation within the fluid path of the inhalation therapy device by the membrane unit.

[0055] The arrangement of the measurement port in the flow path also enables at least an accurate assessment of the quality of inhalation and, from this, an inference as to whether, for example, inhalation has been carried out for long enough or should be further prolonged. Likewise, not only can the flow in the first flow direction be assessed, but also the flow in the second flow direction, i.e. the exhalation by the user through the inhalation therapy device. This assessment enables an optimized activation of the membrane unit of the inhalation therapy device and / or a so-called "breath trigger".

[0056] Preferably, the measurement port is arranged upstream of the membrane of the flow path when viewed in the first flow direction. In other words, the measurement port is arranged "behind" the membrane unit when the inhalation therapy device is held by the user and / or used for inhalation therapy. The measurement quality can thereby be improved, since an undesired amount of aerosol / fluid particles, sputum and / or bacteria originating from the user can be effectively prevented from coming into contact with the measurement port.

[0057] According to a third aspect, the flow path is shaped in such a way that, upon inhalation, the entire flow in the first direction to the first opening passes through the second opening.

[0058] In this respect, the "flow in the first direction" is to be understood as the volume of air breathed by the user upon inhalation through the inhalation therapy device and thus moving in and out of the inhalation therapy device into the respiratory tract of the user. However, for the sake of completeness, it is noted that not all of the volume that passes through the second opening into the inhalation therapy device reaches the respiratory tract of the user due to the volume of the inhalation therapy device itself.

[0059] This enables a reduction in the structural complexity inside the housing body, since any sub-paths, measurement paths, etc. can be omitted. Thus, the device can be more easily sterilized and / or cleaned.

[0060] According to a fourth aspect, the second opening is arranged upstream of the membrane unit when viewed in the first flow direction.

[0061] That is, the second opening can be understood to be arranged "behind" the membrane unit when the inhalation therapy device is used for therapy, i.e. when air is inhaled via the first opening of the flow path into the respiratory tract of the user. This enables the second opening to be arranged away from the first opening, which is arranged downstream of the membrane unit when viewed in the first flow direction. Thus, when viewed in the first flow direction from the second opening through the flow path, the air flow is directed from "behind" the membrane unit, then the air passes through the membrane unit, e.g. by being directed around the membrane unit, the flow through its region around and / or in the second side of the membrane of the membrane unit merges with the generated aerosol, and then is directed through the flow path towards the first opening.

[0062] According to a fifth aspect, the second opening is arranged at an upper half of the housing body when the inhalation therapy device is held by the user during therapy. For example, the therapy will be performed in a sitting position of the user with his or her head in an upright position.

[0063] This enables to prevent that the second opening, through which air enters the flow path, is accidentally blocked by a user holding the inhalation therapy device in a sitting position with his or her head in an upright position during therapy. Thus, it can be ensured that the detection of the flow parameter, e.g. the measurement of the pressure value within the flow path, can be reliably performed during therapy. Vice versa, it can be ensured that the second opening is permanently open and cannot be accidentally blocked.

[0064] Preferably, the second opening is arranged not only in an upper half of the housing body, but also in a region at a distance of 5 mm to 10 mm from an uppermost position of the housing body when the inhalation therapy device is held by the user in a sitting position with his or her head in an upright position during therapy.

[0065] Thus, the risk of accidentally blocking the second opening during therapy can be successfully reduced. This is the case because it is very unlikely that the second opening arranged at the uppermost position of the housing body is blocked by a hand or a finger of a user holding the inhalation therapy device, for example.

[0066] In this respect, the term "uppermost position" is to be understood to refer to the housing body only. Thus, any additional structural elements of the inhalation therapy device, e.g. a lid for covering the reservoir, are not to be considered.

[0067] Alternatively, the term "uppermost position" is to be understood to refer to the flow path in the inhalation therapy device only when the inhalation therapy device is held by the user in a sitting position with his or her head in an upright position during therapy.

[0068] According to a preferred embodiment, the inhalation treatment device can additionally comprise a handle portion for enabling a user to hold the inhalation treatment device comfortably. The holding portion can be reversibly attached to and detachable from a lower portion of the housing body, in this respect, the lower portion of the housing body can be understood as the aerosolization portion. Thus, the second opening is arranged in the aerosolization portion at a position distal from the handle portion, preferably at a position most distal from the handle portion. This again enables to prevent the second opening from being obstructed by a user's hand or finger, for example during a treatment using the inhalation treatment device.

[0069] In another embodiment, the second opening can be shaped as a diversion channel leading to the housing body, i.e. the outer shell of the inhalation treatment device, to more reliably avoid an obstruction by a user or a user's hand / finger during a (inhalation) treatment using the inhalation treatment device. The diversion channel can comprise a rib, a partition or a fin extending towards the housing body to form the outer shell of the device at the position of the second opening in the housing body.

[0070] According to a sixth aspect, the cross-sectional shape of the second opening gradually, preferably continuously, decreases when seen from the first opening to the second opening along the second flow direction.

[0071] This is an exemplary shape of the second opening how to achieve a desired inhalation flow resistance of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa. This enables to prolong the inhalation time and thus to improve the application of the aerosolized fluid or aerosolized liquid, i.e. the medicament, to the user's respiratory tract.

[0072] The cross-section of the second opening gradually, preferably continuously, decreases along the second flow direction such that air entering the fluid path through the second opening upon inhalation faces a narrowing cross-sectional shape and an arc, i.e. a sharp edge at the outermost position of the second opening. This shape causes a flow separation at the outermost position of the second opening leading to an increased flow resistance upon inhalation due to the push of the increasing velocity. At the same time, the decreasing cross-sectional shape along the second flow direction causes a reduced exhalation resistance due to the absence of a sharp edge and thus avoids a flow separation of the flow along the second flow direction.

[0073] This leads to a facilitated exhalation through the inhalation treatment device and thus to a more comfortable feeling of the user as it is not necessary to perform the expulsion of air against a large resistance. Thus, the inhalation time can be prolonged and the exhalation time can be shortened leading to a high duty cycle and thus to a short overall treatment time.

[0074] The "gradually decreasing cross-sectional shape" along the first flow direction can for example be understood as a conical shape of the second opening with a narrower cross-section to the outside of the housing body than to the inside. However, the term is not limited to such a shape.

[0075] The second opening of the fluidic path can be configured as a separate structural element that delimits the fluidic path inside the housing body to the outside, or can be shaped as an integral part of the housing body. In any case, the outermost position of the second opening can protrude from the housing body, or be arranged in a way that is offset inwardly, resulting in a uniform outer shape of the housing body.

[0076] According to a seventh aspect, the end of the second opening that is oriented towards the outside of the housing body comprises an oval, elliptical, polygonal or circular cross-sectional shape.

[0077] Preferably, the second opening comprises a curved housing in the rear portion, i.e. in the region of the second opening that is oriented towards the inside of the inhalation therapy device.

[0078] As mentioned above, this configuration facilitates achieving a desired inhalation flow resistance of at least 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa, while establishing a remaining shape of the inhalation therapy device that is suitable and a reduced exhalation resistance.

[0079] According to an eighth aspect, the end of the second opening that is oriented towards the outside of the housing body comprises a V-shape.

[0080] In other words, the second opening that is oriented towards the outside of the housing body is shaped as a V-shaped nozzle.

[0081] For example, the V-shape is well known in the aerospace (and wind energy) industry as a "serration" pattern on the trailing edge of jet engine nozzles (or windmills) for noise reduction. For example, in aerospace turbines, the sharp edges enable the hot air from the engine core and the cool air flowing through the engine fan to mix smoothly, which reduces the noise that creates turbulence.

[0082] In line with this, the second opening of the flow path through the housing body of the inhalation therapy device can also be provided with such a V-shape, i.e. a serration pattern, on the end of the second opening that is oriented towards the housing body, in order to reduce any noise due to air flow, such as whistling, hissing, etc. Thus, the V-shape is able to reduce background noise during therapy, resulting in an improved application of the inhalation therapy device of the present invention.

[0083] In a preferred embodiment, the V-shape, preferably at least three V-shapes, more preferably six V-shapes, are distributed evenly in a circumferential direction around the end of the second opening that is oriented towards the outside of the housing body.

[0084] According to a ninth aspect, the inhalation treatment device according to any one of the first to seventh aspects can additionally comprise a resilient protection member arranged at the end of the second opening which is oriented towards the outside of the housing body. In this respect, the resilient protection member is shaped in such a way that the second opening remains open when the user inhales and / or exhales through the inhalation treatment device.

[0085] When the inhalation treatment device is accidentally dropped or exposed to other types of impact or stress, the resilient protection member can have a suitable resilience to successfully prevent any damage of the potentially protruding second opening and its potentially protruding sharp edges to the outside of the flow path.

[0086] At the same time, the resilience is chosen in such a way that the resilient protection member does not completely cover the second opening during inhalation / exhalation. That is, the resilient protection member should not be understood as a duckbill valve or the like which would cause the second opening to close when the user inhales at the first opening. Rather, the resilient protection member is shaped in such a way that the second opening remains open at any time, i.e. even when the user inhales and / or exhales through the inhalation treatment device. Thus, the resilient protection member is a protection member for protecting the second opening from any damage caused by external forces, while not affecting the achievable flow resistance established by the shape of the second opening itself.

[0087] However, in another configuration, the deflection of the resilient protection member during inhalation (and exhalation) can contribute to achieve the required flow resistance during inhalation (and exhalation) by correspondingly increasing or decreasing the cross section of the end of the second opening towards the outside of the housing body.

[0088] In particular, the flexibility of the resilient protection member at the second opening can also support the generation of an inhalation resistance which deviates from the exhalation resistance. Upon inhalation, the flexible member of the second opening bends inwards, only partially closing the second opening, thus increasing the inhalation resistance. During exhalation, the resilient protection member bends outwards due to its flexibility, providing more space for the exhalation flow, which results in a lower velocity at the second opening and thus a reduced exhalation resistance. Thus, this embodiment can also be understood as functioning like a cut-off duckbill valve.

[0089] The resilient protection member can be made of TPU (= thermoplastic polyurethane), for example.

[0090] In a preferred configuration, the resilient protection member also comprises a V-shaped piece.

[0091] According to an alternative configuration of the ninth aspect, the inhalation therapy device according to any one of the first to seventh aspects can additionally comprise a protection member arranged at the end of the second opening which is oriented towards the outside of the housing body. In this respect, the protection member is shaped in such a way that the second opening remains open when the user inhales and / or exhales through the inhalation therapy device and the protection member is configured as a plurality of fins, ribs or V-shaped pieces.

[0092] In line with the above configuration, this successfully prevents any damage of the potentially protruding second opening and its potentially protruding sharp edges to the outside of the flow path when the inhalation therapy device is accidentally dropped or exposed to other types of impacts or stresses.

[0093] According to a tenth aspect, the flow path is shaped in such a way that upon inhalation the entire flow in the first direction passes through the second opening and upon exhalation the entire flow in the second direction also passes through the second opening.

[0094] Thus, the air which shall be used for therapy is completely introduced into the flow path towards the first opening for entraining and transporting the generated aerosol through the second opening and at the same time also expelled from the inhalation therapy device via the second opening. Thus, the inhalation therapy device comprises only a single flow path "channel" through which the entire inhalation flow for therapy passes. Also in this respect, for the sake of completeness, it is again pointed out that not all of the volume which passes through the second opening into the inhalation therapy device reaches the respiratory tract of the user due to the volume of the inhalation therapy device itself, i.e. due to its dead space.

[0095] This allows to omit the requirement of having more than one channel in which various related elements, sensors etc. are arranged.

[0096] In this respect, the second opening is shaped as a fixed geometry passive valve. A "fixed geometry passive valve" is to be understood as a geometry which does not require a control and / or the presence of any moving element which needs to be operated to allow air to be introduced into the fluid path and expelled from the fluid path upon exhalation.

[0097] The second opening shaped as a fixed geometry passive valve is configured to create a flow resistance in the first flow direction upon inhalation which is at least 25%, preferably 50%, more preferably 75% and most preferably 90% higher than the flow resistance in the second flow direction upon exhalation.

[0098] The simultaneous increase of the inhalation (flow) resistance and the decrease of the exhalation (flow) resistance provides four main advantages:

[0099] i) The increased respiratory resistance due to the second opening as a flow restrictor leads to a higher drug deposition in the lungs, the maximum flow rate during inhalation is limited. Thus, the amount of drug deposition in the user's lungs can be increased, which allows to reduce the amount of drug compound that needs to be aerosolized for the treatment. Ultimately, this enables a shorter overall treatment time.

[0100] ii) The duration of inhalation is prolonged, leading to a longer (time) window in which the aerosol can be generated, and ultimately to a shorter treatment duration.

[0101] iii) When inhalation is prolonged due to the increased respiratory resistance, exhalation is shortened due to the reduced respiratory resistance by the passive valve of fixed geometry as defined above. This reduces the breathing effort, as the user is able to maintain the respiratory rate and minute ventilation.

[0102] iiii) The inhalation pressure signal usually plays a more important role in opening the aerosolization unit. The increased absolute pressure during inhalation with the inventive shape of the second opening favors the triggering of the membrane unit and leads to an improved treatment, in particular improved reliability and shorter treatment duration.

[0103] In line with the above, these values of the flow resistance in the first and second flow direction are also measured at the peak flow of a (standard) sinusoidal breathing pattern with an inhalation time and exhalation time of two seconds and a tidal volume of 500 ml.

[0104] This can be achieved, for example, by a shape in which, during inhalation, the effective cross section of the second opening is reduced compared to the (effective) cross-sectional shape of the second opening in the exhalation direction, so that an increased flow rate is required in the inhalation direction and, thus, a higher resistance, which allows to achieve a hysteresis effect. Vice versa, in the exhalation direction, essentially the entire cross section of the second opening shaped as a passive valve of fixed geometry can be used, so that exhalation can be performed at a smaller velocity and, thus, against a smaller resistance.

[0105] The shape of the second opening that causes a different inhalation resistance than exhalation resistance can thus also be understood as a "fluidic diode".

[0106] However, the geometry is not limited to the described configuration. Rather, the effect can also be produced by using a shape in which the gas flow is directed to bypass an obstacle (e.g. a turn, a deflection, a narrowing) during inhalation, while during exhalation the gas flow can pass through this section relatively smoothly, i.e. with a reduced flow resistance in the exhalation flow direction. One generally known shape of such a second opening that causes a different inhalation resistance than exhalation resistance can be a "Tesla valve".

[0107] Regardless of the chosen geometry, an inhalation therapy device can be realized in which the inhalation flow resistance is higher than the exhalation flow resistance. This allows the advantages described above to be achieved.

[0108] According to an eleventh aspect, the second opening is not limited to a configuration with a single second opening having a flow path to the outside of the housing body.

[0109] According to the eleventh aspect, the second opening of the inhalation therapy device according to the tenth aspect is formed by a plurality of sub-openings which are each shaped as a passive valve of fixed geometry. Each of the sub-openings provides an opening of a flow path to the outside of the housing body. Furthermore, the sub-openings are configured to together create a flow resistance in the first flow direction when inhaling which is at least 25%, preferably 50%, more preferably 75%, most preferably 90% higher than the flow resistance in the second flow direction when exhaling.

[0110] The division of the configuration of the second opening into a plurality of sub-openings enables the risk of completely blocking the second opening during therapy to be reduced, while at the same time enabling greater freedom to accommodate the flow restrictor on the device. At the same time, the provision of the second sub-openings also allows inhalation flow resistances of 160 Pa ± 100 a, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa, to be achieved, and an exhalation resistance which can be reduced in comparison with the inhalation resistance, as described previously, which advantageously influences the duration of therapy.

[0111] According to a twelfth aspect, the second opening of the inhalation therapy device according to the tenth or eleventh aspect is shaped such that the flow resistance in the first flow direction when inhaling is 25% to 500%, preferably 50% to 300%, more preferably 75% to 200% higher than the flow resistance in the second flow direction when exhaling.

[0112] While the inhalation flow resistance should remain in the range of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa, this configuration and shape of the second opening results in an exhalation resistance which is significantly lower than the inhalation resistance.

[0113] According to a thirteenth aspect, the second opening of the inhalation therapy device according to any one of the tenth to twelfth aspects is shaped in such a way that the flow resistance when exhaling in the second flow direction does not exceed 135 Pa, preferably 100 Pa, more preferably 80 Pa, measured at a peak flow of a (standard) sinusoidal breathing pattern with a two-second inhalation time, a two-second exhalation time and a tidal volume of 500 ml.

[0114] Experiments and flow simulations have shown that, for the above reasons, the above-mentioned configuration of inhalation flow resistance and said maximum exhalation resistance of 80 Pa is a preferred range for entraining and delivering the aerosol generated to the respiratory tract of the user.

[0115] Considering the fact that these inhalation and exhalation resistances can be achieved by the second opening being shaped as a passive valve of fixed geometry, a particularly simple, compact, but effective inhalation therapy device is allowed.

[0116] According to a fourteenth aspect, the inhalation therapy device according to any one of the tenth to thirteenth aspects further comprises an air filtering device. Preferably, the air filtering device is reversibly detachable and attachable to the housing body. This air filtering device is configured to filter harmful, even toxic, substances from the aerosol generated inside the housing body by the membrane unit and delivered to the respiratory tract of the user upon exhalation by the user, so that the aerosol does not escape into the environment.

[0117] To this end, the air filtering device is shaped so as to cover the second opening, so that upon inhalation, the entire flow in the first flow direction passes through the air filtering device, and upon exhalation, the entire flow in the second flow direction also passes through the air filtering device.

[0118] In an alternative embodiment, the air filter device can be arranged in the flow path at a position upstream of the second opening, when seen in the second flow direction (i.e. the second opening can be placed downstream of the filter).

[0119] Irrespective of the chosen configuration, the entire flow in the first and second directions passes through the second opening and the air filtering device. It should be noted in this context that the shape of the air filtering device and the second opening together result in an increased inhalation and exhalation flow resistance. This means that the air filtering device and the second opening together are crucial for defining the flow resistance in the inhalation and exhalation directions.

[0120] However, in another embodiment, the resistance of the second opening during inhalation and exhalation can be adjusted so as to minimize the additional breathing resistance due to the filter.

[0121] According to a fifteenth aspect, the inhalation therapy device according to any one of the first to ninth aspects further comprises a third opening leading to the outside of the housing body, wherein the third opening is arranged in the fluid path between the first opening and the second opening.

[0122] This third opening is provided with a check valve configured to restrict the flow in the first flow direction through the first opening and configured to allow the flow in the second flow direction from the first opening through the third opening to the second opening, so as to enable at least partially, preferably substantially entirely, expelling air through the third opening.

[0123] This inhalation treatment device is configured to allow the inhalation flow through the second opening, as the "check valve" at the third opening blocks the opening in the fluid path upon inhalation, while upon exhalation through the inhalation treatment device, the third opening and its check valve reduce the resistance for expelling air from the inhalation treatment device due to the opening of the check valve. This way, at least a substantial part of the expelled air can be expelled at the third opening through this freely open check valve. Hence, the "check valve" can equally be interpreted as a "one-way valve" establishing a hysteresis. The increased opening area of the second opening and the third opening combined during exhalation leads to a reduced local flow velocity at the openings at a given volumetric flow rate and hence to a reduced exhalation resistance.

[0124] According to a sixteenth aspect, the third opening in the inhalation treatment device according to the fifteenth aspect is arranged upstream of the membrane unit of the fluid path when seen in the first flow direction.

[0125] Hence, the third opening and its check valve can be arranged far enough away from the first opening meeting the user's mouth or mouth and nose, so that an unpleasant feeling of air expelled through the inhalation treatment device can be avoided.

[0126] According to a seventeenth aspect, the inhalation treatment device according to the fifteenth or sixteenth aspect further comprises an air filter device, which is preferably reversibly detachable and attachable to the housing body. The air filter device is configured to filter harmful substances from the aerosol. Furthermore, the air filter device is shaped to cover the third opening, preferably the second opening and the third opening, so that the flow in the second flow direction upon exhalation passes through the air filter device outside the housing body.

[0127] In alternative embodiments, the air filter device can be arranged in the flow path at a position upstream of the second opening and the third opening when seen in the second flow direction (i.e. the second opening and the third opening can be placed downstream of the filter).

[0128] This configuration makes it unnecessary for the inhalation flow from the second opening to the first opening (i.e. the direction of the inhalation flow through the housing body to entrain and transport the generated aerosol) to pass through the air filter device. At the same time, by covering the third opening and its check valve with the air filter device, safety of the environment during treatment can be ensured, so that the main flow in the second flow direction can be filtered. Hence, a substantial amount of toxic substances can be avoided to be expelled from the inhalation treatment device into the environment. BRIEF DESCRIPTION OF DRAWINGS

[0129] In the following, non-limiting examples of the present disclosure are explained with reference to the enclosed drawings, in which:

[0130] Figure 1 An embodiment of an inhalation treatment device according to the present invention is shown in a perspective view.

[0131] Figure 2 A schematic cross-sectional view along Figure 1 the flow path of the inhalation therapy device is shown.

[0132] Figure 3 An exemplary configuration of the second opening of the inhalation therapy device is shown.

[0133] Figure 4 Another exemplary configuration of the second opening of the inhalation therapy device is shown.

[0134] Figure 5 Yet another exemplary configuration of the second opening of the inhalation therapy device is shown.

[0135] Figure 6 An inhalation flow into the second opening of the inhalation therapy device of the present invention is shown.

[0136] Figure 7 An exhalation through the inhalation therapy device and its second opening is shown.

[0137] Figure 8 An exemplary configuration of the second opening with a protective member is shown. DETAILED DESCRIPTION

[0138] The presently preferred embodiments of the present disclosure will now be described with reference to the accompanying drawings. The preferred embodiments relate to an inhalation therapy device 1.

[0139] In the following, preferred embodiments of the inhalation therapy device 1 of the present disclosure will be described with reference to Figure 1 and Figure 2 In the following, preferred embodiments of the inhalation therapy device 1 of the present disclosure will be described with reference to

[0140] It is to be understood that such an inhalation therapy device 1 is also commonly referred to as “aerosol delivery device” or “nebulizer”, e.g. for therapeutic use in / through the respiratory system of a user.

[0141] Figure 1 An exemplary perspective view of the inhalation therapy device 1 according to the presently preferred embodiments of the present disclosure is shown.

[0142] It can thus be derived that the overall shape of the inhalation therapy device 1 is divided into two main parts. The inhalation therapy device 1 comprises a holding part 16, which can also be referred to as “controller part”, and an aerosolization part 17, which can also be referred to as “nebulizer part” or “nebulizing means”. However, the present disclosure is not limited to such a “split” configuration: it is also possible to form the holding part 16 and the aerosolization part 17 as one integral element. Although as Figure 1The holding portion 16 shown is intended to enable the inhalation therapy device 1 to be held by the user during the (aerosol) therapy, but the aerosolization unit 17 itself is arranged to be accessed via the membrane unit 3 (which will be described in more detail below) Figure 2 in more detail) to aerosolize or nebulize a fluid or liquid (i.e. a medicament, a drug, an active substance, a radioactive substance, etc.).

[0143] The holding portion 16 can comprise the most relevant, preferably all, electronic features necessary for operating the inhalation therapy device 1, so that the aerosolization unit 17 can be configured as a disposable product or a product to be used for a certain amount of time (e.g. a certain number of therapies, weeks or months). At the same time, the holding portion 16, which comprises all relevant electrical and sensor elements for operating the inhalation therapy device 1 and monitoring the therapy process, can be interpreted as a durable element, which hardly needs to be cleaned or particularly disinfected before each therapy. For example, for cleaning the holding portion 17, a moistened cleaning tissue is sufficient.

[0144] In order to make the aerosolization unit 17 well cleanable and to easily access the membrane unit 3 arranged inside the aerosolization unit 17, according to Figure 1 exemplary embodiments a latch 18 is provided. The latch 18 enables access to the interior of the inhalation therapy device 1, in particular to the membrane unit 3 inside the aerosolization unit 17 of the inhalation therapy device 1.

[0145] In the given technical field, such a membrane unit 3 is also referred to as "head unit". Similarly, the aerosolization unit 17 is referred to as "nebset", which reflects the abbreviation of the nebulization device.

[0146] Figure 1 The preferred embodiment shown is an inhalation therapy device 1, through which the user inhales and exhales during the therapy. That is, the inhalation therapy device 1 is in contact with the mouth of the user, for example by a mouthpiece, or with the mouth and nose of the user, for example by a face mask, so that the user inhales and exhales regularly through the inhalation therapy device 1. That is, during the aerosol therapy, the inhalation therapy device 1, in particular its first opening 8 (which will be described in more detail below), should not be removed from the mouth (mouthpiece) or mouth and nose (face mask) of the user.

[0147] How the aerosol is generated and how the actual therapy is performed inside the inhalation therapy device 1 will now be described in more detail with reference to Figure 2

[0148] Figure 2 A cross-sectional view along the flow path 7 through the inhalation therapy device 1 is shown, and in this respect, focus is on Figure 1 the (upper) aerosolization unit 17 of the inhalation therapy device 1. Thus, Figure 2 ​Only the uppermost part of the holding portion 16 is shown in the

[0149] The circumference of the inhalation therapy device 1, in particular of the aerosolization unit 17 thereof, is defined by the housing body 4.

[0150] Here and in the following, it is to be understood that Figure 2 The orientation of the inhalation therapy device 1 is shown when the user holds the inhalation therapy device 1 in the ideal position during a standing or sitting therapy.

[0151] In this case, the reservoir 2 for holding a fluid or liquid, i.e. a medicament, is arranged at the upper part of the housing body 4. From Figure 1 It is apparent from the Figure 2 In the In order to make orientation easier, the cover is not shown in the

[0152] Furthermore, it is derivable from Figure 2 that the membrane unit 3 is also arranged in the housing body 4.

[0153] In order to generate an aerosol for the therapy, the membrane unit 3 comprises a membrane 5 and an actuator 6. In Figure 2 The cross-sectional view shows that the membrane 5 is arranged in the housing body 4 in an upright position, i.e. in a vertical position, so that the membrane 5 can encounter the fluid or liquid held in the reservoir 2. In other words, the reservoir 2 and the membrane 5 are arranged adjacent to each other so that the liquid can be supplied to a first side 5.1 of the membrane 5 when the fluid or liquid is held in the reservoir 2. This enables the fluid or liquid to be transported to the membrane 5 of the membrane unit 3 automatically, i.e. gravitationally, by gravity, to generate an aerosol for the therapy of the user. This is achieved by arranging the membrane 5 at the lowest position of the reservoir 2 when the inhalation therapy device 1 is held by the user during the therapy (see Figure 2 ).

[0154] The membrane 5 comprises a plurality of orifices, and the actuator 6 is coupled to the membrane 5 so that the actuator 6 can vibrate the membrane 5. By doing so, the liquid passes through the orifices and an aerosol is generated at a second side 5.2 of the membrane 5 opposite the first side 5.1 of the membrane 5. That is, for example, the aerosol is generated in the chamber at the left-hand side of the membrane unit 3 inside the housing body 4 upon inhalation. Figure 2

[0155] In order to entrain and transport the aerosol generated at the second side 5.2 of the membrane 5 within the housing body 4 of the inhalation therapy device 1 to the respiratory tract of the user, the inhalation therapy device 1 comprises a flow path 7.

[0156] The flow path 7 comprises a first opening 8 at one end thereof leading to the outside of the housing body 4 and a second opening 9 at the other end thereof leading to the outside of the housing body 4. In Figure 2 In the embodiment shown, the first opening 8 and the second opening 9 are arranged at opposite sides of the housing body 4 and can be formed as separate structural elements forming the end portions of the flow path. However, the arrangement is not restrictive and it is also possible that, for example, the position of the second opening 9 is arranged offset from the longitudinal axis through the first opening 8 of the flow path 7 and that the first and second openings of the flow path 7 are an integral part of the housing body (having a shape described in more detail below).

[0157] As already mentioned, the first opening 8 will be in contact with the respiratory tract of the user through the mouth or mouth and nose of the user, directly or indirectly (e.g. through a face mask), for inhalation and exhalation through the inhalation therapy device 1 during aerosol therapy.

[0158] Conversely, the second opening 9 allows air to enter the flow path 7 and to exit therefrom. Thus, the fluid path 7 and its first and second openings 8, 9 leading to the outside of the housing body 4 are such that when the user inhales at the first opening 8, a flow is generated in the fluid path 7 from the second opening 9 to the first opening 8 at least in a first flow direction A.

[0159] The membrane unit 3 is arranged in the flow path 7 and thereby in said "flow" which can be generated by the user breathing, in particular his or her inhalation, such that the membrane unit 3 can be at least partially surrounded by the flow through the flow path 7. For example, the membrane unit 3 can be arranged in an axially and circumferentially central position of the flow path 7 such that during breathing through the inhalation therapy device 1 during therapy, during inhalation of the user, and preferably during exhalation, the sheath envelope flow can pass the membrane unit 3 within the flow path 7.

[0160] In this regard, the above-mentioned flow from the second opening 9 to the first opening 8 in the first flow direction A can also be understood as an inhalation flow (cf. Figure 2 Since the exhalation of the user shall also be conducted through the inhalation therapy device 1, when the user exhales at the first opening 8, a second flow direction B can also be generated in the fluid path 7 from the first opening 8 to the second opening 9, which can be understood as an "exhalation flow".

[0161] Figure 2 The first flow direction A and the second flow direction B are shown. In addition thereto, Figure 2 The curved arrow extending from the second opening 9 to the first opening 8 in the middle represents an exemplary flow path 7 of air in the first flow direction A, i.e. the inhalation flow.

[0162] Since the membrane unit 3 within the fluid path 7 is arranged to be at least partially, preferably completely, surrounded by the air sheath flow when the user inhales through the inhalation therapy device 1, the aerosol generated at the second side of the membrane can be merged with the air guided through the fluid path 7 from the second opening 9 in the area in front of the second side 5.2 of the membrane 5 in the first flow direction A and thus can be "transported" to the first opening 8 to entrain the generated aerosol and transport it to the respiratory tract of the user.

[0163] This is the case because the inhalation of the user at the first opening 8 establishes the above-mentioned "flow" due to the suction force on the air within the fluid path 7 and the air entering the flow path 7 via its second opening 9.

[0164] To assess the quality of the inhalation therapy, it is necessary to observe the way inhalation and exhalation are performed through the inhalation therapy device 1. In this regard, a "good therapy" equals a therapy in which, among other parameters, the inhalation flow rate is low and the tidal volume is high. A low inhalation flow rate can be achieved by increasing the flow resistance during inhalation. However, if the resistance during inhalation and exhalation is increased above a certain level, this can lead to an unpleasant feeling or even breathing difficulties for the user, which increases the chance that the inhalation therapy is interrupted by the user. If the exhalation resistance is reduced, this can be avoided, leading to a shortened exhalation duration and, thus, to a normal minute ventilation of the user can be maintained. This fact increases the ratio between the inhalation and exhalation duration, which leads to a higher duty cycle in the operation of the membrane unit 3 and, finally, to a shorter therapy time. In case a pressure sensor is used, it also improves the signal quality of the sensor during inhalation, thus allowing an accurate triggering of the membrane unit 3. In summary, the quality of the therapy is thus improved.

[0165] So far, the preferred embodiment of the present disclosure finds a solution that is easy to manufacture and to sterilize, which achieves a beneficial short total therapy time in which the inhalation flow rate can be limited without an unpleasant resistance during therapy.

[0166] To assess the flow parameters at least when the user inhales, the inhalation therapy device 1 comprises a sensor 10 configured to detect, for example, a pressure value within the flow path 7. To this end, the sensor 10 comprises a measurement port 11 arranged in the flow path 7. Accordingly, the sensor 10 can detect a pressure value via the measurement port 11 for assessing the flow resistance of at least the inhalation flow in the flow path 7. As Figure 2 is shown, the arrangement of the measurement port 11 allows the sensor 10 to be arranged within the flow path 7 away from the measurement port 11. From Figure 2As can be seen in the cross-sectional view, for example, the sensor 10 can be arranged in the holding portion 16, while the measurement port 11 can be arranged in the fluid path 7 through the housing body 4 of the aerosolization unit 17. In order to be able to detect the flow pressure, the measurement port 11 and the sensor 10 can be connected, for example, via a hose, as shown in Figure 2 The pressure sensor 10 can be, for example, a differential pressure sensor, which determines the static pressure within the fluid path 7 and compares it to the ambient pressure, i.e. the reference pressure.

[0167] In order to achieve the success of the desired aerosol therapy, the inventors have detected that, in particular, an inhalation flow resistance of 160 Pa ± 30 Pa inside the housing body 4 allows to achieve a sufficient resistance to the regular breathing pattern of the user, while not making the inhalation resistance too high for the user, which could potentially lead to an early termination of the therapy.

[0168] In order to establish said flow resistance when the user inhales, the second opening 9 is shaped to act as a flow restrictor. That is, when the user inhales at the first opening 8, the geometry of the second opening 9 acts as an “obstacle” for the air being sucked into the fluid path 7 into the inhalation therapy device 1.

[0169] At the same time, the shape of the second opening 9 acts as a less strong “obstacle” for the air being expelled from the patient’s airways upon exhalation into the flow path 7. Thus, a stronger inhalation resistance compared to the exhalation resistance can be achieved.

[0170] In order to precisely and comparatively measure and determine the flow parameters within the housing body 4 and its fluid path 7 when the user inhales, the flow measurement will be taken by the above-mentioned pressure sensor 10 and at a peak flow value of a sinusoidal breathing pattern with an inhalation time of two seconds, an exhalation time of two seconds, and a tidal volume of 500 ml. This is precisely defined in DIN ISO 27427.

[0171] In the exemplary embodiment of Figure 2 In the exemplary embodiment of Figure 3 to Figure 5 In the embodiment of

[0172] In the embodiment of Figure 2 Upon exhalation, the entire flow along the second flow direction B also passes through the second opening 9.

[0173] In this regard, from Figure 3It is apparent that the second opening 9 is arranged at the upper half of the housing body 4.

[0174] Reference will now be made to Figure 4 The actual shape of the second opening 9, which is responsible for considering it as a flow restrictor, will be described in more detail.

[0175] To achieve the above-mentioned flow resistance by the shape of the second opening, a geometry needs to be established that makes the flow resistance in the inhalation flow direction higher than the flow resistance in the exhalation flow direction. A typical relationship of the inhalation flow resistance to the exhalation flow resistance established by the shape of the second opening is 125%, 150%, 175%, 200%, or even 300% or 400%. In the most preferred embodiment, the relationship of the inhalation flow resistance to the exhalation flow resistance established by the shape of the second opening is 200%. Thus, an inhalation resistance of 160 Pa can be established, while the exhalation resistance is "only" 80 Pa.

[0176] To achieve the same effect, the second opening 9 of the fluid path is shaped as a passive valve of fixed geometry. The second opening 9 can be formed as an integral part of the housing body 4 or as a separate structural element that is connected to the housing body 4 and forms the outlet of the fluid path 7 through said housing body 4 for delivering the generated aerosol to the user during the treatment.

[0177] From Figure 5 , Figure 2 to Figure 5 , Figure 2 to Figure 5 and Figure 3 It can be seen that the cross-sectional shape of the second opening 9 continuously decreases along the second flow direction B. This continuously decreasing cross-sectional shape of the second opening 9 along the second flow direction B makes it possible for the flow resistance in the first flow direction A to be higher than the flow resistance in the second flow direction B without any active elements, such as actuated valves or the like. However, it is not necessarily required to establish said relationship of the inhalation flow resistance to the exhalation flow resistance with only one single second opening 9 in the housing body 4. It is equally possible that the relationship of the inhalation flow resistance to the exhalation flow resistance is achieved by multiple sub-openings that together form the above-mentioned flow resistance of the second opening 9. However, to make orientation easier, the focus will now be on embodiments with a single second opening 8, as shown in Figure 4 .

[0178] Figure 5 The embodiments of Figs. 1 to 3 share a continuously decreasing cross-sectional shape along the second direction B, but their shape differs, which can be seen most easily at the end 12 of the second opening 9 that is oriented towards the outside of the housing body 4.

[0179] Depending on the desired shape on the outside of the housing body 4 and its appearance, for example, the end 12 of the second opening 9 can be formed which is oriented with an oval or elliptical cross-sectional shape towards the outside of the housing body 4. This is shown in Figure 5 .

[0180] At the same time, it can be seen from Figure 6 , for example, that the end 12 of the second opening 9 can also be provided as a polygon, here a rectangular cross-sectional shape, which likewise establishes the desired relationship between the inhalation flow resistance and the exhalation flow resistance established by the shape of the second opening.

[0181] Thus, as is exemplarily shown in Figure 6 , an end 12 with a circular cross-sectional shape can also be provided. The desired inhalation flow resistance of 160 Pa ± 30 Pa within the flow path 7 in the housing body 4 can be established, for example, upon inhalation by the user, wherein the cross-sectional shape of the second opening 9 continuously decreases in the second flow direction B, resulting in an inner diameter of the second opening 9 of approximately 6.6 mm, a radius of the shown bell mouth (which can also be understood as a suction bell mouth) of 6.5 mm, and a radius of the "bell" of 5 mm.

[0182] As is apparent from Figure 7 , regardless of the cross-sectional shape of the end 12, the end 12 of the second opening 9 can be provided with V-shaped elements 13 which positively influence the noise propagation due to inhalation (and exhalation) through the inhalation therapy device. These "serration" patterns, also referred to as V-shaped elements 13, at the end 12 of the second opening 9 make it possible to omit any undesirable acoustic side effects during treatment using the inhalation therapy device.

[0183] In order to facilitate the understanding of the shape of the second opening, which enables it to act as a flow restrictor, reference will now be made to Figure 6 and 7 , which show exemplary geometrical shapes and flow lines of an exemplary inhalation flow Figure 6 and an exemplary exhalation flow Figure 7 through the second opening 9 of the fluid path. Since Figure 6 shows the inhalation flow, the arrows for the first flow direction A are highlighted in bold, while the arrows for the (not shown) second flow direction B are shown in dashed lines in Figure 6 . Since Figure 7 shows the exhalation flow, the arrows for the second flow direction B are highlighted in bold, while the (not shown) arrows for the first flow direction A are shown in dashed lines.

[0184] From Figure 7It is apparent that the air sucked into the flow path 7 via the second opening 9 acting as a flow restrictor is directed towards a sharp edge, namely the end portion 12 of the second opening 9 which is oriented towards the outside of the housing body 4. Irrespective of its elliptical, polygonal or e.g. circular cross-sectional shape, this fluid-dynamically sharp edge (of the end portion 12) reduces the effective cross-section for the suction flow due to flow separation. From Figure 6 It can be seen that the air passes through the end portion 12 of the second opening only in the first flow direction A with the first flow diameter D1. This leads to a relatively high velocity of the flow through the second opening 9 and thus to a relatively high flow resistance. The flow resistance upon inhalation by the user is thus achieved by the shape of the second opening 9.

[0185] With reference to Figure 3 it is apparent that these flow rate limiting effects are generally not given in the exhalation flow direction B. This is because the shape of the second opening 9 is such that in the second flow direction B, the air flow does not encounter any sharp edges, so that the entire cross-section of the second opening 9, in particular the end portion 12 of the second opening 9 to the outside of the housing body 4, can be used by the air expelled to the outside during inhalation by the user. This is shown by the second flow diameter D2 in Figure 4 It is apparent that the first flow diameter D1 (suction flow diameter) shown in Figure 5 is smaller than the second flow diameter (exhalation flow diameter) at the end portion 12 of the second opening 9 (D1 < D2). The velocity of the flow through the second opening 9 is thus relatively low and, accordingly, the flow resistance is relatively low. In summary, the fixed-geometry passive valve uses the hysteresis effect between the two flow directions. Here, the flow resistance upon exhalation should not exceed 135 Pa, preferably 80 Pa, which is measured at a peak flow of 500 ml and a tidal volume of two seconds of sinusoidal breathing pattern at inhalation and exhalation times, respectively, since these 135 Pa do not lead to a feeling of discomfort during exhalation as well as an increased inhalation resistance.

[0186] In addition to the various exemplary shapes of the second opening 9 shown in Figure 8 , Figure 8 and Figure 3 , Figure 4 another exemplary configuration of the second opening 9 is shown. In the embodiment shown in Figure 5 it can be combined with any shape of the second opening 9 shown in Figure 8 , Figure 2 to Figure 8 and Figure 1 , the end portion 12 of the second opening 9 is additionally provided with a protective member. In ​In exemplary embodiments of the protective member, the protective member is implemented via a plurality of ribs in a circumferential direction around the end 12 of the second opening 9. This enables protection of the "sharp edges" of the second opening 9, which is open to the environment of the inhalation therapy device 1, from any damage or mechanical stress.

[0187] In a further preferred configuration, the second opening 9 can be arranged in the housing body 4 in such a way that the end 12 of the second opening 9 is flush with the outer circumference of the housing body 4. This enables protection of the end 12 of the second opening 9 from any damage or mechanical stress.

[0188] Reference is made to ​ All aspects discussed are based on the case that the entire flow of inhalation and exhalation is directed through the second opening 9 of the flow path 7.

[0189] However, in another embodiment, a further third opening 14 to the outside of the housing body 4 can also be provided in the flow path 7 between the first opening 8 and the second opening 9.

[0190] This is shown, for example, in ​ When viewed in the first flow direction A, the third opening 14 is arranged upstream of the membrane unit 3. Furthermore, the third opening 14 is provided with a non-return valve 15, which is configured to restrict the flow through the third opening 14 in the first flow direction A. That is, the non-return valve 15 prohibits any flow through the third opening 14 of the flow path 7 upon inhalation. However, the non-return valve 15 is also configured to enable a flow from the first opening 8 through the third opening 14 to the second opening 9 in the second flow direction B in order to enable a partial exhalation of air through the third opening 14.

[0191] Whether or not the third opening 14 is present, in a further not shown embodiment, the inhalation therapy device 1 can comprise an air filter device, which is reversibly attachable to and detachable from the housing body 4. The air filter device is configured to filter harmful substances from the aerosol. If the third opening 14 is present, the air filter device is shaped to cover the third opening 14, its non-return valve 15 and the second opening 9, such that the flow in the second flow direction B upon exhalation passes through the air filter device to the outside of the housing body 4. Vice versa, if the third opening 14 is not present and the flow path 7 extends only between the first opening 8 and the second opening 9, the air filter device is shaped to cover the second opening 9, which is the only opening of the flow path 7 to the outside of the housing body 4, in addition to the first opening 8, such that the entire flow in the first flow direction A upon inhalation and the entire flow in the second flow direction B upon exhalation passes through the air filter device.

[0192] According to a further, not shown embodiment, the end portion 12 of the second opening 9 which is oriented towards the outside of the housing body 4 can be provided with a resilient protection member. This resilient protection member is intended to protect the above-mentioned sharp edge of the end portion 12 of the second opening 9 and is shaped such that the second opening remains open even when the user inhales and / or exhales through the inhalation therapy device 1.

[0193] List of reference signs

[0194] 1 inhalation therapy device

[0195] 2 reservoir

[0196] 3 membrane unit

[0197] 4 housing body

[0198] 5 membrane

[0199] 5.1 first side of the membrane

[0200] 5.2 second side of the membrane

[0201] 6 actuator

[0202] 7 flow path

[0203] 8 first opening

[0204] 9 second opening

[0205] 10 sensor

[0206] 11 measurement port

[0207] 12 end portion

[0208] 13 V-piece

[0209] 14 third opening

[0210] 15 check valve

[0211] 16 grip portion

[0212] 17 aerosolization portion

[0213] 18 latch

[0214] 19 protection member (rib)

[0215] A first flow direction

[0216] B second flow direction

[0217] D1 first flow diameter

[0218] D2 second flow diameter

Claims

1. An inhalation therapy device (1) comprising: a housing body (4), a reservoir (2) for holding a liquid, a membrane unit (3) comprising: a membrane (5) provided in the housing body (4) and having a plurality of orifices, wherein the membrane (5) is arranged such that when a liquid is held in the reservoir (2), the liquid is supplied to a first side (5.1) of the membrane (5), and an actuator (6) coupled to the membrane (5) for vibrating the membrane (5) whereby the liquid passes through the orifices and generates an aerosol at a second side (5.2) of the membrane (5) opposite the first side (5.1) of the membrane (5), wherein the inhalation therapy device (1) further comprises a flow path (7) defined in the housing body (4) and having a first opening (8) to the outside of the housing body (4) at one end and a second opening (9) to the outside of the housing body (4) at the other end, such that when a user inhales at the first opening (8), a flow is generated in the flow path (7) at least in a first flow direction (A) from the second opening (9) to the first opening (8) to entrain and transport the generated aerosol, and when the user exhales into the flow path (7) at the first opening (8), a flow is generated in the flow path (7) in a second flow direction (B) from the first opening (8) to the second opening (9); and wherein the membrane unit (3) is arranged in the flow path (7) between the first opening (8) and the second opening, characterized in that the second opening (9) is shaped to function as a flow restrictor configured to establish a flow resistance of 160 Pa ± 100 Pa, preferably 160 Pa ± 60 Pa, more preferably 160 Pa ± 30 Pa, when the user inhales, and to establish a flow resistance that is at least 25% lower than the flow resistance when inhaling, when exhaling, the flow resistance being measured at a peak flow of a sinusoidal breathing pattern with an inhalation time and an exhalation time of two seconds each and a tidal volume of 500 ml.

2. Inhalation treatment device (1) according to claim 1, wherein the inhalation therapy device (1) further comprises a sensor (10) comprising a measurement port (11) arranged in the flow path (7), preferably upstream of the membrane unit (3) when looking in the first flow direction (A), the sensor (10) being configured to detect a flow parameter of the flow in the flow path (7) via the measurement port (11).

3. Inhalation treatment device (1) according to any one of the preceding claims, wherein the flow path (7) is shaped in such a way that the entire flow along the first direction (A) to the first opening (8) when inhaling passes through the second opening (9).

4. Inhalation treatment device (1) according to any one of the preceding claims, wherein the second opening (9) is arranged upstream of the membrane unit (3) when looking in the first flow direction (A).

5. Inhalation treatment device (1) according to any one of the preceding claims, wherein The second opening (9) is arranged in an upper half of the housing body (4) when the user holds the inhalation therapy device (1) in a sitting position with the user's head in an upright position during therapy.

6. Inhalation treatment device (1) according to any one of the preceding claims, wherein The cross-sectional shape of the second opening (9) gradually decreases when seen along the second flow direction (B) from the first opening (8) to the second opening (9).

7. Inhalation treatment device (1) according to any one of the preceding claims, wherein The end (12) of the second opening (9) oriented towards the outside of the housing body (4) comprises an elliptical, polygonal, preferably rectangular or circular cross-sectional shape.

8. Inhalation treatment device (1) according to any one of the preceding claims, wherein The end (12) of the second opening (9) oriented towards the outside of the housing body (4) comprises a V-shaped piece (13).

9. The inhalation treatment device (1) according to claims 1 to 7, wherein A protection member is arranged at the end (12) of the second opening (9) oriented towards the outside of the housing body (4), the protection member being shaped such that the second opening (9) remains open even when the user inhales and / or exhales through the inhalation therapy device (1), wherein the protection member is a plurality of ribs, fins or V-shaped pieces (13), or wherein the protection member is a resilient protection member, and preferably the resilient protection member comprises a V-shaped piece (13).

10. Inhalation treatment device (1) according to any one of the preceding claims, wherein The flow path (7) is shaped in such a way that the entire flow in the first direction (A) passes through the second opening (9) upon inhalation and the entire flow in the second direction (B) passes through the second opening (9) upon exhalation, and wherein the second opening (9) is shaped as a fixed-geometry passive valve configured to generate a flow resistance in the first flow direction (A) upon inhalation that is at least 25%, preferably 50%, more preferably 75%, most preferably 90% higher than a flow resistance generated in the second flow direction (B) upon exhalation, the flow resistances being measured at the peak flow of the sinusoidal breathing pattern with an inhalation time and an exhalation time of two seconds and a tidal volume of 500 ml.

11. The inhalation treatment device (1) according to claim 10, wherein The second opening (9) is formed by a plurality of sub-openings, the plurality of sub-openings being respectively shaped as fixed-geometry passive valves, and wherein the sub-openings are configured to together generate a flow resistance in the first flow direction (A) upon inhalation that is at least 25%, preferably 50%, more preferably 75%, most preferably 90% higher than a flow resistance in the second flow direction (B) upon exhalation, the flow resistances being measured at the peak flow of the sinusoidal breathing pattern with an inhalation time and an exhalation time of two seconds and a tidal volume of 500 ml.

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

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

14. The inhalation treatment device (1) according to any one of claims 10 to 13, wherein The inhalation therapy device (1) further comprises an air filter device, which is preferably reversibly detachable from the housing body (4), wherein the air filter device is configured to filter harmful substances from the aerosol, and wherein the air filter device (1) is shaped to cover the third opening (14) such that the flow in the second flow direction (B) passes through the air filter device to the outside of the housing body (4) when exhaling.

15. The inhalation treatment device (1) according to any one of claims 1 to 9, wherein A third opening (14) to the outside of the housing body (4) is provided in the flow path (7) between the first opening (8) and the second opening (9), and wherein the third opening (14) is provided with a check valve (15) configured to restrict the flow through the third opening (14) in the first flow direction (A) and configured to allow the flow from the first opening (8) through the third opening (14) to the second opening (9) in the second flow direction (B) to allow at least partially, preferably substantially completely, expelling air through the third opening (14).

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

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

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