DE102016219759A1 - Sensor unit for an inhaler, inhaler and monitoring device - Google Patents

Abstract

A sensor unit for an inhaler, comprising a motion sensor, which is adapted to detect a shaking motion and optionally to provide corresponding motion sensor output signal, a position sensor, which is designed to determine its orientation in three-dimensional space and optionally the presence of a preferred orientation for the delivery of inhalant is prescribed to provide indicative position sensor output, a trigger sensor adapted to detect a trigger measurand which, upon initiation of a delivery of inhalant, provides a prior art trigger measurement signal and optionally provides a trigger sensor output signal an ambient sensor configured to detect, in the presence of the trigger sensor output signal, a current value of at least one ambient atmosphere measured variable characterizing an atmospheric environment of the sensor unit and a detected one rt corresponding ambient sensor output signal, and a message unit configured to detect the motion sensor output signal, the position sensor output signal and the ambient sensor output signal in the presence of the trigger sensor output signal, and to save together with current timestamp data or a message Interface to external output.

Description

The present invention relates to a sensor unit for an inhaler, an inhaler and a monitoring arrangement with an inhaler.

From the publication DE 692 25 604 T2 is an inhaler with feedback for the patient as well as for medical personnel known. The apparatus described therein is intended to improve compliance with medical treatment by providing feedback to a patient regarding correct and consistent use of a medicament inhaler. The device described in this publication determines how much air is inhaled through the inhaler over time and detects certain events, such as triggering the release of the aerosol. Furthermore, the device includes a motion sensor which serves to determine whether the container of the device is shaken before each actuation.

The aim of the present invention is to improve such a known inhaler.

• – einen Bewegungssensor, der ausgebildet ist, eine Schüttelbewegung zu detektieren und gegebenenfalls entsprechendes Bewegungssensor-Ausgangssignal zu liefern;
• – einen Lagesensor, der ausgebildet ist, seine Orientierung im dreidimensionalen Raum zu ermitteln und gegebenenfalls ein das Vorliegen einer Vorzugsorientierung, die für die Abgabe von Inhalationsmittel vorgeschrieben ist, anzeigendes Lagesensor-Ausgangssignal zu liefern;
• – einen Auslösesensor, der ausgebildet ist, eine Auslöse-Messgröße zu erfassen, die bei einem Auslösen einer Abgabe von Inhalationsmittel ein vorbekanntes Auslöse-Messsignal liefert und gegebenenfalls ein Auslösesensor-Ausgangssignal zu liefern;
• – einen Umgebungssensor, der ausgebildet ist, bei Vorliegen des Auslösesensor-Ausgangssignals einen aktuellen Wert mindestens einer Umgebungsatmosphären-Messgröße zu erfassen, die eine atmosphärische Umgebung der Sensoreinheit charakterisiert, und ein dem erfassten Wert entsprechendes Umgebungssensor-Ausgangssignal zu liefern; und
• – eine Nachrichteneinheit, die ausgebildet ist, bei Vorliegen des Auslösesensor-Ausgangssignals das Bewegungssensor-Ausgangssignal, das Lagesensor-Ausgangssignal und das Umgebungssensor-Ausgangssignal zu erfassen, und zusammen mit aktuellen Zeitstempeldaten zu speichern oder über eine Nachrichten-Schnittstelle nach extern auszugeben.

According to a first aspect of the present invention, a sensor unit for an inhaler is proposed. The sensor unit comprises:

• A motion sensor configured to detect a shaking motion and to provide, if appropriate, a corresponding motion sensor output signal;
• A position sensor adapted to determine its orientation in three-dimensional space and, if appropriate, to provide a position sensor output indicative of the presence of a preferential orientation prescribed for the delivery of inhalant;
• A triggering sensor configured to detect a triggering measure which, upon initiation of a delivery of inhalant, provides a previously known triggering measurement signal and optionally to provide a triggering sensor output signal;
• An environment sensor configured to detect, in the presence of the trigger sensor output signal, a current value of at least one ambient atmosphere measurement variable characterizing an atmospheric environment of the sensor unit and to provide an environmental sensor output signal corresponding to the detected value; and
• - A message unit which is adapted to detect in the presence of the trigger sensor output signal, the motion sensor output signal, the position sensor output signal and the ambient sensor output signal, and store together with current timestamp data or externally output via a message interface.

The sensor unit first detects whether there is a necessary for the treatment with an inhalant preparation and correct handling of the inhaler concerned. To do this, the sensor unit uses a motion sensor to detect whether it is properly shaken before operating the inhaler, and whether the inhaler is held in the correct orientation for correct dispensing of the inhalant when actuated.

In connection with triggering a delivery of inhalant, the sensor unit detects at least one ambient atmosphere measured variable. This ambient atmosphere measure provides information about the patient's atmospheric environmental conditions at the time of inhalation. This information provides important clues as to possible health effects on the patient at the time of treatment with the inhalant. Atmospheric pressures, such as certain levels of relative humidity, certain concentrations of pollutants, or articles in the air, can exacerbate the health of asthma patients. The detection and provision of appropriate information on the message unit of the sensor unit according to the invention therefore provide both the patient and a treating physician, this information can be transmitted via the message unit, essential assistance to the situation adapted dosage of the frequency of drug intake.

The sensor unit according to the invention thus enables improved monitoring of environmental factors that influence the health of an asthma patient. As a result, the treatment of the patient can be better adapted to the current situation.

Embodiments of the sensor unit according to the invention are described in more detail below, followed by the description of preferred applications in the form of developments.

The sensor unit according to the invention for an inhaler advantageously forms a component to be integrated in an inhaler, for example in the form of a correspondingly populated printed circuit board. As such, it can be integrated into known commercial inhalation devices. In particular, such known inhalation devices with the Sensor unit according to the invention be retrofitted to expand the scope of functions accordingly.

• – eine von einer Menge an Stickstoffdioxid in der Umgebungsatmosphäre abhängige Messgröße;
• – eine von einer Menge an Schwefeldioxid in der Umgebungsatmosphäre abhängige Messgröße;
• – eine von einer Temperatur der Umgebungsatmosphäre abhängige Messgröße;
• – eine von einer relativen Feuchtigkeit der Umgebungsatmosphäre abhängige Messgröße;
• – eine vom Druck der Umgebungsatmosphäre abhängige Messgröße; und
• – eine von einer Menge in der Umgebungsatmosphäre enthaltener Partikel vorbestimmter Maximalgröße abhängige Messgröße.

In one embodiment, the environmental sensor is configured to detect at least one of the following ambient atmosphere measured variables:

• A measured quantity dependent on an amount of nitrogen dioxide in the ambient atmosphere;
• A measured quantity dependent on an amount of sulfur dioxide in the ambient atmosphere;
• - A dependent of a temperature of the ambient atmosphere measured variable;
• - A dependent of a relative humidity of the ambient atmosphere measured variable;
• - A dependent of the pressure of the ambient atmosphere measured variable; and
• - A dependent of an amount in the ambient atmosphere particles of predetermined maximum size dependent measurement.

The mentioned measured variables are suitable for providing information about the load of the environment atmosphere of the patient with substances that can worsen the health status of an asthma patient.

In one embodiment, different sensors of the sensor unit are distributed via different spatially separated components. Thus, for example, air pollutants such as nitrogen dioxide, sulfur dioxide and particles may be provided in a separate sensor module that is not intended to be installed in an inhaler. In such a case, this separate sensor module has an additional message unit configured to store the ambient sensor output signals detected by the separate sensor module together with current timestamp data or output externally via a module message interface.

In another embodiment, the trigger sensor includes a microphone configured to detect and identify a prior art triggering noise. Such a known triggering sound during the dispensing of inhalation agent can be made identifiable, for example, by storing a corresponding signal pattern and comparing a sound detected by the microphone with the relevant signal pattern. The signal processing capacity required for this purpose can be provided in the form of a suitable signal processor as part of the sensor unit.

In preferred embodiments, the message interface is configured to externally output the motion sensor output, the position sensor output, and the ambient sensor output via a wireless interface. Particularly suitable for this purpose are wireless radio technologies such as Bluetooth or ZigBee. In these technologies, a portable surveillance unit, such as a suitably equipped portable computer, such as a smartphone, and the sensor unit may be carried by the patient and communicate with each other. The advantage of radio technologies is that a line of sight connection between the sensor unit and the monitoring unit is not required. However, where line of sight connection is possible, other known transmission technologies such as red light or infrared light transmission may be used. A wired transmission of information from the message unit to external devices such as a monitoring unit is provided in other embodiments forms. Particularly flexible sensor units contain different interfaces for output.

In other embodiments, the sensor unit includes a display device configured to indicate to a user the presence of the motion sensor output signal or the presence of the preferential orientation. This additionally facilitates the proper preparation and use of an inhaler for the user. As a display device, for example, flares such as light emitting diodes are. However, the signals can also be conveyed via other carriers such as sound. Thus, the delivery of different sounds may help in the correct orientation of the inhaler in preparation for drug delivery.

The sensor unit preferably contains a power supply unit. The energy supply of the sensor unit is carried out in an embodiment in a simple manner with a rechargeable battery as energy storage. In a particularly easy to handle variant, the rechargeable battery is connected to a wireless charging interface and rechargeable via the wireless charging interface.

• – eine Aufnahme für einen Vorratsbehälter mit einem darin befindlichen Inhalationsmittel;
• – ein Betätigungselement, das mit dem Vorratsbehälter verbindbar ist, wenn dieser sich in der Aufnahme befindet, und durch dessen Betätigung eine Abgabe von Inhalationsmittel aus dem Vorratsbehälter veranlassbar ist; und
• – eine Sensoreinheit gemäß dem ersten Aspekt der Erfindung oder einer ihrer Ausführungsbeispiele.

A second aspect of the present invention is an inhaler comprising

• - A receptacle for a reservoir with an inhalant therein;
• - An actuator which is connectable to the reservoir when it is in the receptacle, and by the actuation of a delivery of inhalant from the reservoir is veranlassbar; and
• - A sensor unit according to the first aspect of the invention or one of its embodiments.

The inhaler of the second aspect of the invention includes a receptacle for a Reservoir. In this respect, it is preferably used for different drugs and the reservoir can be exchanged in particular. In an alternative embodiment of the inhaler, which can be used as a "disposable product" for example in the clinical field under increased hygiene requirements, the reservoir is firmly integrated.

Further embodiments of the inhaler correspond in their additional features to the embodiments of the sensor unit.

A third aspect of the present invention is a monitoring assembly incorporating an inhaler of the third aspect of the invention or one of its embodiments. Furthermore, the monitoring arrangement includes a monitoring unit which is connectable to the message unit of the sensor unit of the inhaler to enable data communication and which is adapted to receive the received from the message unit position sensor output, ambient sensor output together with current timestamp data and according to a predetermined processing algorithm to process.

The monitoring unit is, for example, a computer. Preferably, the computer is portable. In particular, mobile computers, such as smartphones, are suitable. The processing of the data obtained by the inhaler in the monitoring unit takes place in particular with the aid of a computer-executable data processing program. In one embodiment, the processing consists in forwarding the received data to a further computer, in particular a server, via a remote transmission network, such as, for example, a mobile radio network.

• – einen Exhalator mit einer Exhalations-Sensoreinheit, die ausgebildet ist, einen aktuellen Wert mindestens einer Exhalations-Messgröße zu erfassen, die Information über eine stoffliche Zusammensetzung eines Exhalationsluftstoßes enthält, und
• – eine Nachrichteneinheit, die ausgebildet ist, die mindesten eine Exhalations-Messgröße zu erfassen und zusammen mit aktuellen Zeitstempeldaten zu speichern oder über eine Nachrichten-Schnittstelle an die Überwachungseinheit auszugeben.

In a further embodiment of the arrangement additionally comprises

• An exhaler with an exhalation sensor unit, which is designed to detect a current value of at least one exhalation measured variable which contains information about a material composition of an exhalation air blast, and
• - A message unit, which is adapted to detect the at least one exhalation measured variable and store together with current timestamp data or output via a message interface to the monitoring unit.

With the additional information that the patient / user can detect with the help of the exhalator when exhaling the breath, the current state of health of the patient with additional accuracy can be determined. This additional information can thus be used to provide additional information to the patient for the future dosage of the drug, for example in the form of an altered number of sprays in an inhalation.

In a further embodiment, the arrangement additionally contains an activity monitor, which is designed to detect information about activity of the patient in the form of physical movement with suitable attachment to the body of the patient. Such an activity monitor may for example be in the form of a wrist-worn device. Such a device may additionally be designed to detect, for example with a PPG sensor, information about the current pulse and the oxygen saturation of the blood of the patient.

Hereinafter, further embodiments will be explained with reference to the drawings. Show it:

1 a block diagram of a sensor unit according to an embodiment of the invention;

2 a block diagram of another embodiment of a sensor unit of the present invention;

3 a photographic representation of an inhaler with inserted drug reservoir according to an embodiment of the present invention, here in the open state;

4 a photographic representation of the inhaler 3 , here in the closed state;

5 an embodiment of a monitoring arrangement according to the present invention; and

6 another embodiment of a monitoring arrangement according to the present invention.

1 shows a block diagram of a sensor unit 100 according to an embodiment of the invention. The sensor unit 100 is on a circuit board 102 integrated. It contains a motion sensor 104 , The motion sensor is implemented in the form of an acceleration sensor. An example of a suitable acceleration sensor is an MMA8451 acceleration sensor from NXP Semiconductors. The acceleration sensor is designed to detect a shaking movement. In the case of detection of a shaking motion, a corresponding motion sensor output signal is generated. For this purpose, a suitable filtering of the motion sensor output signals can be set, with the example slow Movements are filtered out so that only shaking movements, which typically have high frequencies and high acceleration values are detected. Such filtering is already adjustable in the motion sensor itself by suitable integrated signal processing.

Furthermore, the sensor unit contains 100 a position sensor 106 , The position sensor is for example of the type BMX055 from Bosch SensorTec. With the help of the position sensor 106 the orientation of the sensor unit in three-dimensional space can be determined. Depending on the mounting orientation of the sensor unit in a given type of inhaler, a preferred orientation may be specified as the orientation appropriate for the delivery of inhalant. The position sensor provides a corresponding position sensor output signal when setting this preferred orientation.

The sensor unit 100 also contains a trigger sensor 108 in the form of a microphone module 108 , One in the microphone module 108 built-in microphone (example: MP34DT01 of ST Microelectronics) is followed by a signal processing, not shown here, which is designed to identify a tripping noise when triggering a release of inhalant based on the detected characteristic sound signal and optionally to provide a corresponding trigger sensor output signal.

The sensor unit further includes an environmental sensor in the form of an environmental sensor 110 , The environment sensor is configured to detect at least one ambient atmosphere measurement that is an atmospheric environment of the sensor unit 100 characterized. The environmental sensor provides an environmental sensor output signal corresponding to the sensed value. In one embodiment, the environmental sensor is configured to measure ambient pressure, ambient temperature, and the relative humidity of the atmospheric environment. Suitable for this example is a BME280 sensor from Bosch SensorTec. In another embodiment, the environmental sensor additionally detects certain substances present in the atmosphere environment. Of course, instead of the integration of a signal evaluation into the respective sensor modules, alternatively or additionally, a signal processing and evaluation downstream of the sensor is possible in a microcontroller or microprocessor, not shown here.

The sensor unit 110 also contains a message unit 112 , which is the different sensor output signals of the sensors 104 - 110 be supplied. The news unit 112 is configured, in particular in the presence of the trigger sensor output signal to store a set of sensor output signals with a current time stamp or via an in 1 output not shown message interface. Such a message interface can, for example, connect the sensor unit to a base board, as described below with reference to FIG 2 is explained in more detail. However, the detection and output of sensor output signals can of course also be done at other times.

The message interface of the message unit 112 allows in the embodiment shown here a wired electrical signal transmission via electrical contacts.

With reference to the embodiment described below the 2 explains how the message unit 112 may alternatively be formed, in particular to provide one or more message interfaces for the implementation of different forms of data communication with external devices as an extension.

2 shows a block diagram of another embodiment of a sensor unit 200 for an inhaler. The sensor unit 200 contains a sensor part in the form of the sensor unit 100 out 1 , but with a below explained in more detail feature deviation. For details of the design of the sensor part is therefore on 1 directed. Furthermore, the sensor unit contains 200 a news unit 202 in the form of a news module 202 with a number of communication modules for implementing different forms of data communication. The exact features of the news module 202 can be adapted to the needs of a particular application. With the present equipment, which is described in more detail below, a particularly high degree of flexibility in the implementation of data communication is achieved. In the present embodiment is on the sensor unit 100 instead of the above related 1 alone a wired electrical interface (for example, a connector) for signaling to the message module 202 intended. The news module 202 is connected to this interface and receives corresponding sensor output signals from it via the electrical interface. The received signals can then be processed by a microcontroller 203 in the form of messages in accordance with a respectively suitable message protocol, either individually or in parallel via one of the following message interfaces: an infrared interface 204 , a USB interface 206 , and / or a radio interface, for example a Bluetooth interface 208 ,

The 3 and 4 show photographic representation of an inhaler 300 , The inhaler has a receptacle 302 for a storage container 304 with an inhalant contained therein. By means of an actuating mechanism, which can not be recognized in the figure, an intermittent delivery of the inhalant through a mouthpiece can be achieved 306 to be triggered. The mechanism in the present example provides that the patient to trigger the reservoir 304 depressed with a release force. Furthermore, the inhaler contains a sensor unit 308 in their functionality one of the above-described embodiments of the sensor units 100 and 200 equivalent. 4 shows the inhaler 300 out 3 with an attached housing 310 which is the interior of the inhaler 300 protects.

5 shows an embodiment of a monitoring arrangement 500 according to the present invention. The monitoring arrangement serves to support the monitoring of the state of health of, for example, asthma patients. An inhaler 502 is equipped with a sensor unit according to one of the embodiments described above. He is about his message unit and its message interface with a monitoring unit 504 connected. The monitoring unit 504 is in this example a smartphone. A software application (App) installed on the smartphone is used to receive, evaluate and forward the information from the inhaler 502 transmitted data. Further measurement data is received by the monitoring unit 504 from an exhaler with connected sensor unit 506 , This provides values of exhalation measures of the breath of air exhaled by a patient, for example temperature as an indicator of the presence of respiratory infection, and additionally measures indicative of a material composition of the ambient atmosphere, in particular the concentration of nitrogen dioxide, sulfur dioxide and certain particles in the ambient air. The exhaler contains this 506 also a message unit with appropriate functionality as described above for the sensor unit of the inhaler. The arrangement also includes an activity monitor 508 in the form of a wrist-worn motion sensor that provides information about the user's motion profile. Finally, the monitoring arrangement 500 an additional sensor 510 have, for example, is designed to detect certain substances in the breathing air as an additional breathing air sensor. Alternatively or in addition to the monitoring unit 504 can be an evaluation computer 512 be provided. This has in particular greater storage capacity and more powerful processors, so that more complex evaluation and monitoring algorithms can be performed. From the monitoring unit 504 The data collected is sent to a database 514 In addition, they can be forwarded via a data connection to other external computers in a server environment (cloud), with which they are additionally evaluated in connection with other patient data processed there and reactions in the form of further therapy offers, instructions for drug dosing or immediate can cause medical contact.

6 is a schematic illustration of another embodiment of a monitoring arrangement. The surveillance arrangement 600 is presently based on local data communication in a realized via Bluetooth communication Body Area Network of the patient 602 limited. The monitoring unit 604 , here as well as in the embodiment of 5 designed as a smartphone, collects measurement data from an inhaler 606 , an exhaler 608 , an activity monitor 610 and an environmental sensor 612 , evaluates these and, after appropriate data processing, provides instructions to the patient for further dosage and time planning of the therapy.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 69225604 T2 [0002]

Claims (10)

Sensor unit for an inhaler, comprising A motion sensor configured to detect a shaking motion and to provide, if appropriate, a corresponding motion sensor output signal; A position sensor adapted to determine its orientation in three-dimensional space and, if appropriate, to provide a position sensor output indicative of the presence of a preferential orientation prescribed for the delivery of inhalant; A triggering sensor configured to detect a triggering measure which, upon initiation of a delivery of inhalant, provides a previously known triggering measurement signal and optionally to provide a triggering sensor output signal; An environment sensor configured to detect, in the presence of the trigger sensor output signal, a current value of at least one ambient atmosphere measurement variable characterizing an atmospheric environment of the sensor unit and to provide an environmental sensor output signal corresponding to the detected value; and - A message unit which is adapted to detect in the presence of the trigger sensor output signal, the motion sensor output signal, the position sensor output signal and the ambient sensor output signal, and store together with current timestamp data or externally output via a message interface. Sensor unit according to claim 1, wherein the environmental sensor is designed to detect at least one of the following ambient atmosphere measured variables: A measured quantity dependent on an amount of nitrogen dioxide in the ambient atmosphere; One of a quantity dependent on the amount of sulfur dioxide in the ambient atmosphere; - A dependent of a temperature of the ambient atmosphere measured variable; - A dependent of a relative humidity of the ambient atmosphere measured variable; and - A dependent of the pressure of the ambient atmosphere measured value. The sensor unit of claim 1, wherein the triggering sensor includes a microphone configured to detect and identify a prior art triggering noise that arises upon initiation of the delivery of inhalant. A sensor unit according to any one of the preceding claims, wherein the message interface of the message unit is adapted to externally output the motion sensor output signal, the position sensor output signal and the ambient sensor output signal via a wireless interface. Sensor unit according to one of the preceding claims, with a display device which is designed to indicate to a user the presence of the motion sensor output signal or the presence of the preferred orientation. Sensor unit according to one of the preceding claims, comprising a power supply unit which contains an energy store and a wireless charging interface, wherein the energy store can be charged via the wireless charging interface.  Inhaler, comprising - A receptacle for a reservoir with an inhalant therein; - An actuator which is connectable to the reservoir when it is in the receptacle, and by the actuation of a delivery of inhalant from the reservoir is veranlassbar; and - A sensor unit according to any one of the preceding claims. An inhaler according to claim 7, wherein a reservoir having an inhalant therein is contained in the receptacle. Monitoring arrangement comprising An inhaler according to claim 7 or 8, - A monitoring unit which is connectable to the message unit of the sensor unit of the inhaler and which is adapted to receive from the message unit received position sensor output signal, ambient sensor output together with current timestamp data and to process according to a predetermined processing algorithm. Arrangement according to claim 9, additionally comprising An exhaler with an exhalation sensor unit, which is designed to detect a current value of at least one exhalation measured variable which contains information about a physical property or a substance composition of an exhalation air blast, and - A message unit, which is adapted to detect the at least one exhalation measured variable and store together with current timestamp data or output via a message interface to the monitoring unit.

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