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    • 专利摘要:
    A monitoring system for monitoring the handling of an inhaler (10) comprises a flow measuring device (45) for determining a flow signal indicating a flow rate through the inhaler (10) and a secondary measuring device (49) for determining a secondary signal indicating the handling of the inhaler . An event analyzer (47) receives the flow signal and the secondary signal and analyzes these signals with regard to temporal correlations. Based on the temporal correlations between the flow signal and the secondary signal, the event analyzer determines whether a handling event has occurred. This reduces the likelihood that incorrect handling events will be detected.
    公开号:CH715947A2
    申请号:CH00247/20
    申请日:2020-03-02
    公开日:2020-09-15
    发明作者:Alt Andreas；Zipkes Christoph；Hornung Mark
    申请人:Sensirion Ag；
    IPC主号:
    专利说明:

    TECHNICAL AREA
    The present invention relates to a monitoring system for monitoring the handling of a medical inhaler, to a method for operating such a monitoring system and to a corresponding computer program product.
    STATE OF THE ART
    Inhalers are the most widely used devices for treating respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). They are designed to deliver a drug in the form of an aerosol (i.e. a dispersion of fine solid particles or liquid droplets in air) into the patient's lungs. The most common types of inhalers are pressurized metered-dose inhalers (MDIs) and dry-powder inhalers (DPIs).
    An MDI is e.g. disclosed in US 2002/0144678 A1. The drug is stored in solution or suspension together with a propellant in a pressure vessel. The container is closed with a metering valve. The container is held in a plastic housing which delimits an air inlet and an air outlet of the inhaler. The housing forms a mouthpiece at the air outlet. The housing comprises a socket for receiving a valve stem of the metering valve. The socket defines a channel that leads to a nozzle opening located in the air flow path between the air inlet and the air outlet of the inhaler. In use, the user inhales through the mouthpiece. This creates a flow of air through the housing and past the nozzle opening. After the user has started to inhale, he pushes the container into the housing onto the valve stem, which is seated in the socket, whereby the metering valve is opened and a metered amount of the medicament is released through the nozzle opening. The released medicament mixes with the air flow and is thus inhaled by the user through the mouthpiece.
    Studies have shown that many patients make at least one mistake when using an inhaler that results in incomplete drug delivery into the lungs. The two biggest and most serious mistakes in using an MDI are both related to the patient's inhalation. The first mistake is a lack of coordination between inhalation and the triggering of the inhaler dose release; even a short delay can mean that only a small amount of the drug gets to the lungs. The second most important mistake is not breathing deep enough, which can also result in less drug getting into the lungs.
    [0005] Andreas Alt, “Flow Measurements in Smart Inhalers for Connected Drug Delivery”, ONdrugDelivery 93 (2018), pp. 22-26, deals with these questions. The document discloses a 3-D printed inhaler attachment that includes a flow sensor for monitoring inhalation events. The principle of flow measurement is based on the Venturi / Bernoulli effect, and the flow sensor is arranged in such a way that the air flow through the inhaler to which the additional device is attached is not disturbed. Further details are contained in European patent application No. 18 207 022.7, which was filed on November 19, 2018 by the same applicant as the present patent application. The content of this European patent application is incorporated herein by reference in its entirety.
    It is often necessary that the user shake the inhaler before use to ensure a good mixture of the drug and the propellant in the drug container. When using an inhaler for the first time, it may be necessary to first flush the drug pathway inside the inhaler by performing multiple pseudo-release events, operating the inhaler as in a normal drug-release event, but without inhaling through the inhaler.
    WO 2017/178865 A1 discloses an MDI which is equipped with an additional device which is attached to a mouthpiece part of the MDI. The additional device comprises a first pressure sensor for registering changes in air pressure due to inhalation by the user, a second pressure sensor for registering the compression of the housing of the additional device when the user releases the medication, and a movement sensor for registering movements due to the MDI being shaken by the User. If the additional device registers shaking processes with the aid of the motion sensor, it wakes up from a sleep mode in order to monitor a subsequent drug delivery process. During the drug delivery process, an inhalation event is detected based on the signals from the first pressure sensor and a drug release event based on the signals from the second pressure sensor. The event detection is always based on the signals of a single sensor. This can lead to the device registering incorrect events.
    DISCLOSURE OF THE INVENTION
    It is an object of the present invention to provide a monitoring system for monitoring the handling of an inhaler, which monitoring system has a reduced likelihood that false events will be registered.
    [0009] This object is achieved by a monitoring system according to claim 1. Further embodiments of the invention are given in the dependent claims.
    The present invention provides a monitoring system for monitoring the handling of an inhaler, the monitoring system comprising:<tb> <SEP> a flow measuring device for determining a flow signal indicative of a flow rate through the inhaler;<tb> <SEP> a secondary measuring device for determining a secondary signal indicating the handling of the inhaler; and<tb> <SEP> an event analyzer designed to perform the following procedure:<tb><SEP> <SEP> receiving the flow signal from the flow measuring device;<tb><SEP> <SEP> receiving the secondary signal from the secondary measuring device;<tb><SEP> <SEP> analyzing the flow signal and the secondary signal with regard to temporal correlations; and<tb><SEP> <SEP> Determination of an event indicator which indicates a handling event during handling of the inhaler, taking into account the temporal correlations between the flow signal and the secondary signal.
    According to the invention, the flow signal is correlated with a secondary measurement signal for recognizing certain handling events. In this way, events can be registered more reliably than if only the signals from a single sensor are used, and the chance that incorrect events will be registered is reduced.
    In some embodiments, the secondary measuring device comprises an acceleration sensor which is configured to detect movements of the inhaler, and the secondary signal is accordingly an acceleration signal. In this case, the acceleration sensor can not only be used to correlate the flow rate with the movements of the inhaler in order to detect certain handling events, but it is also possible, on the basis of the acceleration signals received from the acceleration sensor, to orientate the inhaler during its use determine. This can be important information for at least some types of inhaler.
    In other embodiments, the secondary measuring device comprises a microphone which is configured to detect sound signals that can be attributed to the handling of the inhaler. In particular, certain noise patterns are characteristic of certain actions that are carried out by the user, e.g. drug release or shaking, and such sound patterns can be recognized and correlated with flow rate to more reliably detect certain handling events.
    In other embodiments, the secondary measuring device has an actuation sensor that is configured to detect actuation signals that indicate actuation of the inhaler. The actuation sensor can be sensitive to movements between a medicament container of the inhaler and a housing part of the inhaler. The actuation sensor can be an inductive sensor. In the case of an MDI, the actuation consists in the user pushing the medication container into the housing, and the actuation sensor can accordingly e.g. be arranged next to the drug container to detect movements of the drug container relative to the housing. With other types of inhalers, the actuation sensor can be arranged next to other inhaler parts in order to detect relative movements between two inhaler parts. Such movements can be correlated with the flow rate in order to detect certain handling processes more reliably.
    In some embodiments, the event indicator may be a shake event indicator that indicates that a user is shaking the inhaler. In this case, the event analyzer is configured to determine the shake event indicator taking into account the following cumulative conditions:<tb> <SEP> the secondary signal indicates that the inhaler is exposed to a movement pattern that is characteristic of shaking; and<tb> <SEP> the flow signal indicates a flow rate pattern that matches the movement pattern.
    The shaking event indicator can indicate not only whether the inhaler was shaken at all, but also whether the shaking was performed correctly, e.g. with sufficient strength and for a sufficiently long time interval.
    If, for example, the secondary measuring device is an acceleration sensor, the acceleration signal determined by the sensor shows rapid oscillation behavior when the inhaler is shaken, the amplitude of the acceleration signal depending on the intensity of the shaking process. This characteristic movement pattern is easy to recognize. Due to the inertia of the air inside the inhaler, the flow signal also oscillates rapidly. This characteristic flow pattern is also easy to recognize. The movement pattern and the flow rate pattern can then be compared to see if they match one another, i.e. whether they occur simultaneously and have similar properties. If a movement pattern but no matching flow rate pattern is detected, or vice versa, this can indicate either a false detection or a malfunction of the device and thus trigger further analysis.
    A similar analysis can also be carried out if the secondary measuring device is a microphone that records a characteristic noise pattern due to the shaking of the inhaler, or if the secondary measuring device is an actuation sensor that also generates characteristic signals due to inevitable relative movements of the inhaler parts (in particular small relative movements between the medication container and the housing) when shaking the inhaler.
    The secondary measuring device often requires significantly less electrical energy than the flow measuring device for its operation. It is therefore advantageous to activate the flow meter only when the secondary signal indicates that the inhaler is being moved. In particular, the event analyzer can be configured to perform the following procedure:<tb> <SEP> Operation in a sleep mode in which the secondary meter is activated while the flow meter is deactivated;<tb> <SEP> executing a wake-up routine when the secondary signal indicates that the inhaler is exposed to movement, the wake-up routine causing the flow measuring device to be activated;<tb> <SEP> operating the flow measuring device to determine the flow signal and to transmit the flow signal to the event analyzer; and<tb> <SEP> Determination of the shaking event indicator taking into account the temporal correlations between the flow signal and the secondary signal.
    In some embodiments, the event indicator may be a trigger event indicator that indicates that a user is actuating the inhaler while inhaling through the inhaler. In this case, the event analyzer is configured to determine the triggering event indicator based on the following cumulative conditions:<tb> <SEP> the flow signal shows a flow pattern that is characteristic of inhalation through the inhaler;<tb> <SEP> the secondary signal indicates that the inhaler is subject to a movement pattern characteristic of a drug release event; and<tb> <SEP> the movement pattern characteristic of a drug release event occurs while the flow pattern is indicative of inhalation.
    In other words, an inhalation event as determined by the flow meter is correlated with a drug release event as determined by the secondary measurement device, and these events are correlated to avoid false drug release events from being detected. The flow measurement defines the time frame in which the secondary signal can potentially indicate a drug release event. This correlation analysis is particularly advantageous if the secondary measuring device is an acceleration sensor or a microphone. When such sensors are used to detect drug release events, the likelihood that false drug release events will be detected is particularly high unless the secondary signals from these sensors are compared to an independent signal, e.g. the flow signal, checked twice. By analyzing the correlations between the flow signal and the secondary signal, it is practically possible to dispense with a separate trigger sensor and instead use the acceleration sensor or the microphone to detect drug release events.
    A drug release event can also cause a small additional signature in the flow signal itself that is superimposed on the flow rate pattern by inhalation. Therefore, it can be beneficial if the event analyzer is configured to take into account the following additional conditions:<tb> <SEP> the flow signal shows an additional flow signature that is characteristic of a drug release event during inhalation, in addition to the flow rate pattern that is characteristic of inhalation through the inhaler; and<tb> <SEP> the additional flow signature occurs concurrently with the movement pattern characteristic of a drug release event as determined by the secondary meter.
    In some embodiments, the event indicator may be a pseudo release event indicator that indicates that a user is actuating the inhaler without inhaling through the inhaler, and the event analyzer is configured to determine the pseudo release event indicator based on the following cumulative conditions:<tb> <SEP> the secondary signal indicates that the inhaler is subject to a movement pattern characteristic of a drug release event;<tb> <SEP> the flow signal indicates a flow signature that is characteristic of a drug release event in the absence of inhalation; and<tb> <SEP> the flow signature that is characteristic of a drug release event in the absence of inhalation occurs concurrently with the movement pattern that is characteristic of a drug release event.
    In this way it is possible to monitor whether the user has correctly flushed the inhaler before the first use.
    The monitoring system can comprise an optical or acoustic output device that outputs feedback on the handling by the user on the basis of the event indicator. The monitoring system can e.g. Provide feedback on whether the inhaler was shaken correctly, whether the inhalation was performed correctly, whether a drug release event was correctly timed during the inhalation, or whether the inhaler was properly flushed prior to first use.
    The monitoring system can be configured to transmit the event indicator to a remote device over a wireless connection. The remote device can be, for example, a smartphone, a tablet or notebook computer, or a remote server that is accessible via a wide area network such as the Internet. The monitoring system can for example comprise a module that enables a wireless point-to-point connection with the remote device, such as a Bluetooth ™ module, or a module that enables network communication with the remote device via a wireless connection, e.g. over a WiFi ™ network or over a cellular network such as a GSM network. The remote device can be used to provide feedback to the user, medical staff, or a remote analyzer instead of, or in addition to, providing user feedback on the inhaler itself.
    Additionally or alternatively, the event indicator can be stored in the monitoring system or in the remote device in order to be read out later.
    The present invention further provides an inhaler or an accessory for an inhaler, comprising a monitoring system of the type described above. The accessory can be an accessory which is configured so that it can be detachably attached to an existing inhaler, whereby a standard inhaler is expanded to include "intelligent" functions.
    It is not necessary for the entire monitoring system to form a single unit. In some embodiments, only some of the components of the monitoring system are provided in or on the inhaler itself or in the additional device, while other components are arranged remotely from the inhaler and / or additional device. In particular, it is possible that the flow measuring device and the secondary measuring device are arranged in or on the inhaler or in the additional device, while the event analyzer is arranged in a remote device. The event analyzer can be implemented, for example, as an app on a smartphone, and the inhaler or the additional device can be configured so that the flow signal and the secondary signal are transmitted to the smartphone for analysis.
    [0030] The present invention also provides a corresponding method for monitoring the handling of an inhaler. The procedure includes:<tb> <SEP> determining a flow signal indicative of a flow rate through the inhaler;<tb> <SEP> determining a secondary signal indicating handling of the inhaler;<tb> <SEP> analyzing the flow signal and the secondary signal with regard to temporal correlations; and<tb> <SEP> Determination of an event indicator which indicates a handling event during handling of the inhaler, taking into account the time correlations between the flow signal and the secondary signal.
    As already discussed, the secondary signal may be an acceleration signal that indicates movements of the inhaler, a sound signal that indicates noises during handling of the inhaler, or an actuation signal that indicates the actuation of the inhaler.
    As discussed above, the event indicator may be a shake event indicator, a trigger event indicator, or a pseudo trigger event indicator.
    As discussed above, the method may include providing visual or audible handling information to a user based on the event indicator and / or transmitting the event indicator to a remote device over a wireless connection.
    The present invention further provides a computer program product for operating a monitoring system for monitoring the handling of an inhaler, the monitoring system comprising a flow measuring device for determining a flow signal indicating a flow rate through the inhaler, a secondary measuring device for determining a secondary signal indicating the handling of the inhaler, and having an event analyzer, the computer program product having program instructions which can be executed by a processor of the event analyzer in order to carry out the method described above. The computer program can be stored on a storage medium, in particular on a non-volatile data carrier, or can be made available for downloading via a network.
    BRIEF DESCRIPTION OF THE DRAWINGS
    Preferred embodiments of the invention are described below with reference to the drawings, which serve to illustrate the present preferred embodiments of the invention and not to limit the same. In the drawings show:<tb> Fig. 1 <SEP> in a highly schematic longitudinal section an inhalation system comprising an inhaler and an accessory part, the accessory part implementing a monitoring system according to a first embodiment, together with a remote control device;<tb> Fig. 2 <SEP> shows, in a highly schematic longitudinal section, part of an inhalation system which has an inhaler and an accessory according to a second embodiment;<tb> Fig. 3 <SEP> is a highly schematic block diagram of an exemplary monitoring system for an inhaler;<tb> Fig. 4 <SEP> is a schematic diagram showing acceleration and flow signals when shaking the inhaler;<tb> Fig. 5 <SEP> is a flowchart illustrating a possible wake-up process of the monitoring system in FIG.<tb> Fig. 6 <SEP> is a schematic diagram showing acceleration and flow signals during a trigger event;<tb> Fig. 7 <SEP> is a flowchart showing a possible detection process in the event of a triggering event;<tb> Fig. 8 <SEP> is a schematic diagram showing acceleration and flow signals during a pseudo release event; and<tb> Fig. 9 <SEP> is a flowchart illustrating one possible detection method for a pseudo release event.
    DESCRIPTION OF PREFERRED EMBODIMENTS
    Exemplary embodiment of an inhaler with an accessory comprising a monitoring system
    1 shows, in a highly schematic manner, an inhalation system which includes a monitoring system according to a first embodiment. The inhalation system comprises an inhaler 10 and an accessory 40. The accessory 40 is attached to the inhaler 10 with the aid of a fastening structure 42 so that it can be detached from the inhaler 10. The monitoring system is implemented in the accessory 40.
    In the present example, the inhaler 10 is a typical pressurized MDI inhaler (English. Pressurized MDI, pMDI). It comprises an essentially cylindrical medicament reservoir (medicament container) 11, which has a metering valve at its lower end for the controlled delivery of single doses of medicament through a hollow valve stem 12. The metering valve is actuated by pressing the valve stem 12 into the medicament container 11.
    The medicament container 11 is received in an inhaler housing 20. The inhaler housing 20 is substantially L-shaped. The upright leg of the L forms an upwardly open receiving part for the medicament container 10. The receiving part has the shape of a hollow cylinder which extends upward to an upper end 22. The receiving part is defined by a circumferential housing wall 21. At the open upper end 22 of the receiving part, the housing wall 21 forms an annular end face. The medicament container 11 is held in the receiving part by a plurality of spacer ribs 23 which extend radially inward from the housing wall 21. As a result, the outer circumferential wall of the medication container 11 is spaced apart from the housing wall 21 of the housing 20, and axially extending air channels are thus formed between the housing wall 21 and the medication container 11.
    At the lower end of the receiving part, the inhaler housing 20 contains a hollow nozzle 30. The valve stem 12 of the medicament container 11 sits in the nozzle 30. The nozzle 30 defines a channel 31 which leads from the outlet of the valve stem 12 to a nozzle opening 32. The nozzle opening 32 opens into the interior of the inhaler housing 20 in a lateral direction which runs transversely to the cylinder axis of the receiving part, but not necessarily perpendicular to the cylinder axis.
    The transverse leg of the L-shaped housing 20 extends in the same lateral direction as the nozzle opening 32. At its distal end it forms a hollow mouthpiece 24 for insertion into a user's mouth. The mouthpiece 24 is open laterally at its end 25. It usually has a flattened cross-sectional shape that conforms to the anatomy of a human user's mouth. This cross-sectional shape generally differs from the cross-sectional shape of the receiving part.
    The open upper end 22 of the receiving part of the inhaler housing 20 forms, together with the peripheral wall of the medicament container 11, an air inlet which allows air to enter the inhaler. The open end 25 of the mouthpiece 24 forms an air outlet. A flow path through the inhaler housing 20 exists between the air inlet and the air outlet. The nozzle opening 32 is arranged in this air flow path. Downstream of the nozzle opening 32, the inhaler housing 20 delimits a mixing zone 33 for mixing the air stream with the medicament released from the medicament container 11.
    In use, the user first shakes the inhaler to thoroughly mix the medicament and propellant within the medicament container 11. Then the user exhales and puts his mouth around the mouthpiece 24. The user then inhales through the mouthpiece 24, thereby generating an air flow F1 through the inhaler housing 20 from the air inlet to the air outlet. After the user begins to inhale through the mouthpiece 14, the medication container 11 is pushed down into the housing 20 to release a dose of medication. Due to the pressure in the medicament container 11, the medicament is driven through the channel 31 and the nozzle opening 32 into the mixing zone 33, where it mixes with the air flow to form an aerosol flow F1 'and is inhaled by the user.
    The accessory part 40 comprises an accessory housing 41 which is held on the inhaler housing 20 with the aid of the fastening structure 42. In the present example, the fastening structure 42 forms a ring which is pushed onto the open upper end of the receiving part of the inhaler housing 20. At its upper end, the ring has an inwardly extending flange which rests on the upper end face of the housing wall 21 at the open upper end 22 of the receiving part and thereby forms an axial stop structure together with the upper end 22 of the receiving part. This ensures that the accessory housing 41 is attached to the inhaler housing 20 in a defined axial position.
    In the interior of the accessory housing 41 there is a carrier 50 in the form of a printed circuit board. The carrier 50 carries an electronic pressure sensor 45, a controller 47, a battery 48 and an acceleration sensor 49. An opening in the accessory housing 41 defines a pressure connection 43. The electronic pressure sensor 45 communicates pneumatically via a channel 44 with the pressure connection 43.
    The pressure connection 43 is arranged in an inwardly directed wall section of the accessory housing 41, which directly adjoins the open upper end 22 of the inhaler housing 20. The pressure connection 43 is arranged in such a way that the air flow F1 flows over the pressure connection 43 immediately before it enters the inhaler housing 20 at the air inlet. The surface of the wall part of the accessory housing 41 in which the pressure connection 43 is arranged is flush with the inner surface of the housing wall 21 of the inhaler housing 20. These areas together limit the air flow F1 at the air inlet. The accessory 40 of the first embodiment does not have a structure that protrudes into the air flow F1. This ensures that the air flow F1 is disturbed as little as possible by the presence of the accessory 40.
    In use, the air flow F1, which is caused by the inhalation of the user, causes a negative pressure at the pressure port 43 due to the Bernoulli / Venturi effect, which is created by the acceleration of the air flow when entering the inhaler. The amount of the negative pressure is directly related to the amount of the flow rate of the air flow F1. The negative pressure is registered by the electronic pressure sensor 45. The controller 47 reads the electronic pressure sensor 45 and determines a flow signal from the sensor signals read out by the electronic pressure sensor 45. For this purpose, the controller 47 can use calibration data that relate measured pressure values to known flow values of the air flow F1. In this way, the pressure sensor 45 essentially realizes a flow measuring device for determining an air flow rate through the inhaler 10.
    It should be noted that the pressure sensor 45 not only registers an air flow caused by the inhalation of the user, but also any other air flow through the inhaler 10, including an air flow caused by shaking the inhaler 10 by the user or by the user delivering a dose of the drug without inhalation.
    The electronic pressure sensor 45 can in particular be a differential pressure sensor based on a flow measurement principle. Such a differential pressure sensor has two sensor connections: a sensor inlet and a sensor outlet. A pressure difference between the sensor inlet and the sensor outlet causes a sensor gas flow through a sensor flow channel delimited inside the differential pressure sensor. A flow sensitive structure is arranged adjacent to the sensor flow channel to measure a flow rate of the sensor gas flow through the sensor flow channel. Such a differential pressure sensor thus essentially functions as a flow sensor which is configured in such a way that it determines the pressure difference on the basis of the determination of a flow rate through a flow channel between the sensor connections.
    A suitable flow sensor that can be used to determine the differential pressure is e.g. given in US 2016/0161314 A1. The inlet and outlet pipes of the flow sensor disclosed in this document can function as the sensor connections mentioned in the present disclosure.
    If a differential pressure or flow sensor is used, one of the sensor connections of the sensor is pneumatically connected to the pressure connection 43 in a fluid-tight manner. The other sensor connection is advantageously pneumatically connected to the surroundings of the accessory 40 in an area that is not influenced by the air flow F1. For this purpose, the accessory housing 41 can have a reference connection 46 in the form of an opening, the opening being arranged in a region of the accessory housing 41 facing away from the inhaler. The opening causes the pressure inside the accessory housing 41 to be equal to the ambient pressure of the accessory 40 in an area that is not influenced by the air flow F1. The sensor connection, which is not connected to the pressure connection 43, can therefore simply be opened towards the interior of the accessory housing 41 without a fluid-tight connection between this sensor connection and the reference connection 46 being required.
    Movements of the inhaler cause the acceleration sensor 49 to register acceleration signals. The acceleration signals can in particular be caused by the user shaking the inhaler or by the user pushing the container 11 downwards in order to release a dose of the medicament. However, the acceleration sensor 49 also registers all other movements, including unintentional movements.
    The controller 47 receives flow signals from the pressure sensor 45 and acceleration signals from the acceleration sensor 49 and other signals from all other sensors that may be present in the accessory 40. The controller 47 carries out a monitoring process on the basis of these sensor signals. The monitoring method comprises an analysis of the correlations between the flow signals of the pressure sensor 45 and the acceleration signals of the acceleration sensor 49 in order to detect certain handling events, as will be described in more detail below. The result of the analysis is an event indicator that shows whether a certain type of handling event has taken place. The controller 47 thus implements an event analyzer.
    The accessory 40 may include structure for generating user feedback for the user based on the detected events. For example, the accessory can contain a tone generator that generates an acoustic signal that indicates to the user whether the inhaler has been shaken correctly, whether the flow rate is within a desired range, whether a dose has been delivered at the correct time, etc. As another example the accessory includes a vibrator to generate a tactile signal in the form of a vibration pattern that indicates to the user whether these goals have been achieved. As a further example, the accessory can be a display, e.g. an LCD display or one or more LEDs to produce a visual signal that indicates to the user whether these goals have been achieved.
    The accessory 40 may include a wireless communication module for transmitting the event indicator to a remote device 60 over a wireless connection. The remote device 60 may e.g. be a smartphone, tablet or notebook computer. In other embodiments, the remote device may be a special purpose device specially configured to interact with the accessory 40. In other embodiments, the remote device can be a remote server. The module for wireless communication can e.g. a Bluetooth ™ module for establishing a point-to-point connection between the accessory 40 and the remote device 60, or it can be a WiFi ™ module for connecting the accessory 40 to a wireless LAN that the remote device 60 has contains.
    Differentiation of different flow directions
    It should be noted that the accessory 40 of the first embodiment cannot distinguish between a flow F1 caused by inhalation through the inhaler and a reverse flow in the opposite direction as it can during exhalation through the inhaler would be the case.
    Fig. 2 shows schematically a second embodiment which avoids this disadvantage. The second embodiment is largely identical to the first embodiment and only a portion around the upper open end of the inhaler housing 20 is shown. Elements that have the same functionality as in the first embodiment are denoted by the same reference symbols as in FIG. 1.
    An essential difference of the second embodiment compared to the first embodiment lies in the execution of the accessory housing 41 in the immediate vicinity of the pressure connection 43. While in the first embodiment, the pressure connection 43 is arranged in a smooth wall part of the accessory housing 41, which the air flow F1 only changed minimally, the accessory housing 41 in the second embodiment comprises a flow-modifying structure 51 which deliberately protrudes into the flow path of the air flow F1 in order to change the air flow. In the present example, the flow-modifying structure 51 acts as a local barrier for a reversed air flow F2 immediately downstream of the pressure connection 43, whereby a positive dynamic pressure (dynamic pressure) is generated at the pressure connection 43 for the reversed airflow F2. In this way, the air flow F1 through inhalation and the reversed air flow F2 through exhalation can easily be differentiated on the basis of the sign of the pressure change at the pressure connection 43.
    The fluid-tight connection between the electronic sensor 45 and the channel 44, which leads to the pressure connection 43, is also shown in FIG. 2, symbolized by a seal 52.
    Exemplary structure of the monitoring system
    FIG. 3 is a block diagram which illustrates one possible structure of the controller 47 in a highly schematic manner. The controller comprises a microprocessor 71 which communicates with various other components via a bus 72.
    A ROM module (Read-Only Memory) 73 and a RAM module (Random Access Memory) 77 are also connected to the bus 72. The ROM module 73 stores, inter alia, a first look-up table (LUT) 74, which contains calibration data for determining a flow signal from the output of the electronic pressure sensor 45, and a second look-up table (LUT) 75, the calibration data for contains the acceleration sensor 49. The ROM module 73 also stores program data with instructions for the microprocessor 71 to carry out the monitoring method.
    An input / output interface 78 provides an interface for various input and output devices, in particular for the electronic pressure sensor 45, the acceleration sensor 49, a microphone 81, an inductive actuation sensor 82, a loudspeaker 83 and a visual display 84 such as a LED or an LCD screen.
    A wireless communication module 79, e.g. a Blueetoth ™ or WiFi ™ module, enables a wireless connection to a remote device 60.
    Remote device
    In the present example, the remote device 60 executes a computer program (an "app") that causes the remote device 60 to receive the event indicator from the accessory 40 over the wireless link and generate user feedback via an output device on the remote device. For example, the app can cause the remote device to display the user feedback and / or instructions for correct handling of the inhaler on a screen of the remote device. In another example, the app can cause the remote device to emit an acoustic signal, e.g. a voice message, over a speaker on the remote device, instructing the user to manipulate the inhaler in a particular manner. In another example, the app can cause the remote device to provide tactile feedback, e.g. by vibration, depending on how the user is handling the inhaler. All of this can be done in real time.
    In addition, the app can cause the remote device to store the received event indicators for later reading and / or the received event indicators or variables derived from the received event indicators, such as e.g. statistical data to be transmitted to a remote server for analysis. This enables remote monitoring of the use of the inhaler by medical personnel. In other embodiments, the event indicators are transmitted directly from the accessory to a remote server for analysis.
    Detection of shaking events
    Fig. 4 illustrates how a shaking event can be reliably detected. When the inhaler is shaken, the acceleration sensor 49 outputs an acceleration signal “a” that oscillates rapidly with a high amplitude at the frequency with which the inhaler is shaken. The acceleration signal is registered by the controller 47. The resulting signal pattern 91 is very characteristic of the shaking and can easily be recognized by known pattern recognition algorithms.
    Shaking the inhaler also causes an oscillating flow of air inside the inhaler due to the inertia of the air. This oscillating air flow is detected by the pressure sensor 45, which accordingly outputs an oscillating flow signal “f”, which is shown schematically in FIG. 4 as flow pattern 92.
    In order to reduce the probability of registering a false shaking event or to detect malfunctions of the system, the controller 47 analyzes the acceleration signal “a” and the flow signal “f” to determine whether the movement pattern 91 corresponds to the flow pattern 92. A match is e.g. then detected when both patterns occur at the same time and have vibrations with the same frequency.
    Based on this analysis, the controller 47 determines a shake event indicator. This indicator can be output, transmitted to remote device 60, or stored for later use.
    Between uses, the controller 47 can go into a sleep mode, in which the pressure sensor 45 and other components such as the wireless communication module 79 are deactivated and only the acceleration sensor 49 remains active. The controller 47 can then, through the detection of large acceleration signals, e.g. the signals resulting from the shaking are woken up. When the controller wakes up, it activates the pressure sensor 45 and other components and records both the flow signal and the acceleration signal to perform the analysis described above.
    Fig. 5 is a flow diagram illustrating a corresponding sequence of actions. Initially, the controller is in sleep mode (box 101). If the controller registers movements of the inhaler with the acceleration sensor (box 102), it wakes up (box 103) and also begins to detect flow signals from the pressure sensor (box 104). The controller then correlates the acceleration signal to the flow signal (box 105) to determine the shake event indicator. If the shake event indicator indicates that the system is functioning properly and the shaking was performed correctly (step 106), control begins monitoring the acceleration and flow signals for a drug delivery event (box 108). Otherwise, it issues a corresponding error message (box 107) and / or goes back to sleep mode.
    Detection of drug delivery events
    Fig. 6 shows a typical flow profile 93 during inhalation. The flow rate first increases, then reaches a plateau and finally drops again. A drug release event is registered when the accelerometer detects a typical movement pattern 94 corresponding to a situation where a user is actuating the inhaler to release a dose of drug while the flow signal indicates that inhalation is taking place, e.g. while the flow signal is above a certain threshold. The movement pattern 94 is shown only symbolically in FIG. Its exact shape generally depends on the type of inhaler. This pattern can easily be recognized by pattern recognition algorithms.
    Furthermore, the drug release event can cause a small additional flow signature 95 in the flow signal in addition to the flow profile 93, which can additionally be taken into account for the detection of the drug release event.
    The correlation of the acceleration signal with the flow signal thus makes it possible to reliably detect drug release events with the acceleration sensor, while the sole consideration of the acceleration signal would lead to a large number of false events being registered.
    A corresponding flow chart is shown in FIG. Flow and acceleration signals are recorded (boxes 111, 112). These signals are analyzed in terms of the patterns described above. If typical patterns are recognized in one of the signals, the signals are analyzed for correlations in order to determine an indicator of a triggering event (box 113).
    If the release event indicator indicates that a release event has been registered (step 114), the indicator can be transmitted to the remote device for further analysis (box 115), or user feedback can be derived and output.
    Detection of pseudo-release events
    Figure 8 shows the acceleration signal and flow rate in the case of a pseudo-release event in which the inhaler is operated as if a dose was being released, but without inhalation.
    As in FIG. 6, the acceleration signal shows a typical movement pattern 96 that is characteristic of actuation of the inhaler to release a dose of the medicament. The flow signal has a small signature 97 caused by the flow of propellant within the inhaler. By recognizing and correlating these features, a pseudo release event can be reliably identified.
    The correlation of the acceleration signal with the flow signal thus makes it possible to reliably detect pseudo-release events with the acceleration sensor, while consideration of the acceleration signal alone would lead to a large number of false events being registered.
    A corresponding flow chart is shown in FIG. Flow and acceleration signals are recorded (boxes 121, 122). These signals are analyzed for the characteristics described above. If the features described above are detected in at least one of the signals, the signals are analyzed for correlations to determine a pseudo release event indicator (box 123).
    If the pseudo-release event indicator indicates that a pseudo-release event has been registered (step 124), the indicator can be transmitted to the remote device for further analysis (box 125) or feedback to the user can be derived and provided. For example, if the inhaler has been used for the first time, the number of pseudo-release events that will be required before the inhaler can be used for treatment can be indicated.
    Modifications
    While exemplary embodiments of the invention have been illustrated with reference to the drawings, the invention is in no way limited to these embodiments, and many modifications are possible without departing from the scope of the present invention.
    While in the above-mentioned embodiments the monitoring system is implemented in a single unit (the accessory 40), this does not necessarily have to be the case. The surveillance system can also be distributed across two or more units that interact with each other. For example, instead of performing the correlation of the movement and acceleration signals by the microprocessor 71 in the accessory, the movement and acceleration signals can be transmitted to the remote device 60 and the correlation performed by a processor in the remote device 60.
    Instead of implementing the monitoring system or parts thereof in an accessory part that is separate from the inhaler (“intelligent accessory”), the monitoring system can be implemented in the inhaler itself (“intelligent inhaler”).
    If the monitoring system is implemented using an accessory of an inhaler, the accessory can be attached to the inhaler in a manner other than that described. The accessory can e.g. be clamped onto the inhaler housing with two hook-like arms.
    The flow rate through the inhaler does not have to be determined on the basis of the Bernoulli / Venturi effect, as in the above embodiments. It can also be determined with any other type of flow meter. Many different types of flow meters are known and can be used in connection with the present invention. While it is advantageous to use flow meters that do not interfere with the flow of air through the inhaler, as in the above embodiments, this is not a requirement of the present invention.
    If the flow rate is determined on the basis of the Bernoulli / Venturi effect, the pressure sensor need not be a flow-based sensor, as described above. The pressure sensor can be of any other type, e.g. an absolute pressure sensor or a relative pressure sensor that is based on a different measuring principle than a flow measurement. In particular, the pressure sensor can be a barometric pressure sensor.
    Instead of an acceleration sensor, other types of secondary measuring devices can also be used, in particular a microphone or an actuation sensor.
    The inhaler does not necessarily have to be an MDI. It can be any other type of inhaler, including DPIs.
    REFERENCE LIST
    10 inhaler 11 medication container 12 valve stem 20 inhaler housing 21 housing wall 22 upper end 23 spacer rib 24 mouthpiece 25 air outlet 30 hollow nozzle 31 channel 32 nozzle opening 33 mixing zone 40 accessory 41 accessory housing 42 fastening structure 43 pressure connection 44 channel 45 electronic sensor 46 reference connection 47 control 48 battery 49 Accelerometer 50 carrier 51 flow-modifying structure 52 seal 53, 54 sensor connector 60 remote device 71 microprocessor 72 bus 73 ROM 74, 75 look-up table 76 program memory 77 RAM 78 I / O device 79 communication device 81 microphone 82 inductive sensor 83 loudspeaker 84 visual display 91 movement pattern 92 Flow pattern 93 Flow pattern 94 Movement pattern 95 Additional flow signature 96 Movement pattern 97 Flow signature 101 Sleep mode 102 Motion detection 103 Wake-up procedure 104 Flow detection 105 Correlation 106 Analysis for shaking 107 Error condition 108 Inhalation monitoring 111 Flow detection 112 Motion detection 113 Correlation 114 Analysis for release 115 Transmission 121 Flow detection 122 Motion detection 123 Correlation 124 Analysis for pseudo release 125 Transmission F1 air flow F1 'aerosol flow F2 reverse air flow
    权利要求:
    Claims (15)
    [1]
    1. A monitoring system for monitoring the handling of an inhaler (10), the monitoring system comprising:a flow measuring device (45) for determining a flow signal (f) indicative of a flow rate through the inhaler (10); anda secondary measuring device for determining a secondary signal (a) which indicates the handling of the inhaler (10),characterized in that the monitoring system has an event analyzer (47) which is designed to carry out the following method:Receiving the flow signal (f) from the flow measuring device (45);Receiving the secondary signal (a) from the secondary measuring device (45);Analyzing the flow signal (f) and the secondary signal (a) with regard to temporal correlations; andDetermining an event indicator which indicates a handling event during handling of the inhaler (10), taking into account the temporal correlations between the flow signal (f) and the secondary signal (a).
    [2]
    2. Monitoring system according to claim 1, wherein the secondary measuring device comprises an acceleration sensor (49) which is configured to detect movements of the inhaler (10), and wherein optionally the event analyzer (47) is configured to, on the basis of the acceleration sensor ( 49) received acceleration signals to determine an orientation of the inhaler (10).
    [3]
    3. Monitoring system according to claim 1 or 2, wherein the secondary measuring device comprises a microphone (81) which is configured to detect sound signals during handling of the inhaler (10), or an actuation sensor (82) which is configured to provide actuation signals detect that indicate an actuation of the inhaler (10).
    [4]
    The monitoring system of any preceding claim, wherein the event indicator is a shake event indicator indicating that a user is shaking the inhaler (10), and wherein the event analyzer (47) is configured to determine the shake event indicator taking into account the following cumulative conditions :the secondary signal (a) indicates that the inhaler (10) is exposed to a movement pattern (94) which is characteristic of the shaking; andthe flow signal (f) has a flow pattern (92) which corresponds to the movement pattern (91).
    [5]
    The surveillance system of claim 4, wherein the event analyzer (47) is configured to perform the following method:Operating in a sleep mode in which the secondary measuring device is activated while the flow measuring device (45) is deactivated;Executing a wake-up routine when the secondary signal (a) indicates that the inhaler (10) is exposed to movement, the wake-up routine causing the flow measuring device (45) to be activated;Operating the flow measuring device (45) to determine the flow signal (f) and to transmit the flow signal (f) to the event analyzer (47); andDetermination of the shaking event indicator taking into account the temporal correlations between the flow signal (f) and the secondary signal (a).
    [6]
    6. The monitoring system of any preceding claim, wherein the event indicator is a release event indicator indicating that a user is actuating the inhaler (10) while inhaling through the inhaler (10), and wherein the event analyzer (47) is configured to that it determines the release event indicator based on the following cumulative conditions:the flow signal (f) has a flow pattern (93) which is characteristic of inhalation by the inhaler (10);the secondary signal (a) indicates that the inhaler (10) is exposed to a movement pattern (94) which is characteristic of a drug release event; andthe movement pattern (94) characteristic of a drug release event occurs while the flow pattern (93) is indicative of inhalation.
    [7]
    7. The surveillance system of claim 6, wherein the event analyzer is configured to take into account the following additional conditions:the flow signal (f) has an additional flow signature (95) characteristic of a drug release event during inhalation, in addition to the flow pattern (93) characteristic of inhalation through the inhaler (10); andthe additional flow signature (95) occurs simultaneously with the movement pattern (94) characteristic of a drug release event as determined by the secondary measurement device.
    [8]
    The monitoring system of any preceding claim, wherein the event indicator is a pseudo-release event indicator which indicates that a user is actuating the inhaler (10) without inhaling through the inhaler (10), and wherein the event analyzer (47) is configured to that it determines the pseudo-release event indicator based on the following cumulative conditions:the secondary signal (a) indicates that the inhaler (10) is subjected to a movement pattern (96) which is characteristic of a drug release event;the flow signal (f) has a flow signature (97) which is characteristic of a drug release event in the absence of inhalation; andthe flow signature (97), which is characteristic of a drug release event in the absence of inhalation, occurs simultaneously with the movement pattern (96) which is characteristic of a drug release event.
    [9]
    9. Monitoring system according to one of the preceding claims,the monitoring system including a visual or audible output device (83; 84) configured to output handling information to a user based on the event indicator; and orwherein the monitoring system is configured to transmit the event indicator to a remote device (60) over a wireless connection.
    [10]
    10. Inhaler (10) or accessory part (40) for an inhaler (10), comprising the monitoring system of one of the preceding claims.
    [11]
    11. A method of monitoring the handling of an inhaler (10), the method comprising:Determining a flow signal (f) indicative of a flow rate through the inhaler (10);Determining a secondary signal (a) which indicates handling of the inhaler (10);characterized in that the method further comprises:Analyzing the flow signal (f) and the secondary signal (a) with regard to temporal correlations;Determining an event indicator which indicates a handling event during handling of the inhaler (10), taking into account the time correlations between the flow signal (f) and the secondary signal (a).
    [12]
    12. The method according to claim 11,wherein the secondary signal is an acceleration signal that indicates the movements of the inhaler,wherein the secondary signal is a sound signal indicating noises during handling of the inhaler, orwherein the secondary signal is an actuation signal indicative of actuation of the inhaler.
    [13]
    13. The method according to claim 11 or 12,wherein the event indicator is a shake event indicator that indicates that a user is shaking the inhaler (10), and wherein the shake event indicator is determined based on the following cumulative conditions: the secondary signal (a) indicates that the inhaler (10) has a movement pattern (91) which is characteristic of the shaking, and the flow signal (f) indicates a flow pattern (92) which matches the movement pattern (91); orwherein the event indicator is a release event indicator indicating that a user is actuating the inhaler (10) while inhaling through the inhaler (10), and wherein the release event indicator is determined based on the following cumulative conditions: the flow signal (f) shows indicates a flow pattern (93) which is characteristic of inhalation through the inhaler (10), the secondary signal indicates that the inhaler (10) is exposed to a movement pattern (94) which is characteristic of a drug release event, and the movement pattern ( 94), characteristic of a drug release event, occurs while the flow pattern (93) is indicative of inhalation; orwherein the event indicator is a pseudo-release event indicator which indicates that a user actuates the inhaler without inhaling through the inhaler, and wherein the pseudo-release event indicator is determined taking into account the following cumulative conditions: the secondary signal (a) indicates that the inhaler (10 ) is subjected to a movement pattern (96) which is characteristic of a drug release event, the flow signal (f) shows a flow signature (97) which is characteristic of a drug release event in the absence of an inhalation, and the flow signature (97) which is for a drug release event is characteristic in the absence of inhalation occurs concurrently with the movement pattern (96) characteristic of a drug release event.
    [14]
    14. The method according to any one of claims 11 to 13, further comprising:Outputting visual or audible handling information to a user based on the event indicator; and orTransmitting the event indicator to a remote device (60) over a wireless connection.
    [15]
    15. Computer program product for operating a monitoring system for monitoring the handling of an inhaler (10), wherein the monitoring system comprises a flow measuring device (45) for determining a flow signal (f) which indicates a flow rate through the inhaler (10), a secondary measuring device (49) for Determination of a secondary signal (a), which indicates the handling of the inhaler (10), and an event analyzer (47), wherein the computer program product has program instructions that can be executed by a processor of the event analyzer (47) to the method according to one of the claims 11 to 14.
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    同族专利:
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    EP19160499|2019-03-04|
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