DE102020112097B4 - MEDICAL APPLICATION DEVICE, DETECTION STRUCTURE FOR A MEDICAL APPLICATION DEVICE, METHOD FOR CALIBRATING THE SAME, AND METHOD FOR OPERATING THE MEDICAL APPLICATION DEVICE - Google Patents

Abstract

Medical application device (100) provided for administering a liquid drug, the medical application device (100) comprising: a reservoir (104) which is set up to receive the liquid drug; an application structure (106) which is set up to administer the liquid medicament from the reservoir (104) into an environment (116) external to the application device; a dosing device (108) which is coupled to the reservoir (104) and is set up to set a dose of the liquid medicament in the reservoir (104), which dose can be administered in one application of the medical application device (100), and for administering the dose ; a distance detection device (114) which has an optical transceiver which is set up to detect a distance (118) between the application structure (106) and the environment (116) external to the application device; a position detection device (112) which is set up to detect a position (130) of the medical application device (100) with respect to the environment (116) external to the application device; and a dose detection device (110) which is set up to detect the dose of the liquid medicament to be administered and the administration of the dose.

Description

Various exemplary embodiments relate to a medical application device, a detection structure for a medical application device, methods for calibrating the same and a method for operating the medical application device.

For the self-medication of diseases such as diabetes, patients often use injection devices for liquid medication. Since the therapy takes place in the home setting, reliable logging is crucial for success.

In order to better monitor the therapy, additional electronic devices can be attached to the mostly purely mechanical injection devices. These record the set dose on the injection device and transmit the data together with other data to a mobile device.

In conventional injection devices, for example, the dose setting is recorded using clicks and vibrations when the dosing rotary knob is operated with microphones or acceleration sensors. The dose is calculated from the measured values using specially adapted algorithms. To ensure correct dose detection, however, error-free filtering of interfering signals (e.g. rattling) is necessary. It is also necessary to reliably identify the direction of rotation of the dosing button. If the user corrects the dose, i.e. turning the button in the opposite direction, errors will occur. Manual correction by the user is required.

Various methods are conventionally known for recognizing the click or for differentiating the direction of rotation. A conventional approach is based on the detection of a threshold value (level). If the sensor signal exceeds a threshold value, e.g. the click of a dosing button that is recorded by a microphone, the event is counted as a click (dosing step). However, only the level is considered here, the time course is not analyzed. The conventional algorithm cannot differentiate between a click and an interfering signal, since only the level is considered. Interfering noises, e.g. knocking on the device, can be interpreted as a dose selection. A manual correction or confirmation of the recognized dose by the patient is therefore necessary.

Another conventional approach is based on the detection of the edge rise. The acceleration or the rate of rotation of the dosing button are measured with an acceleration sensor or gyroscope. The course of the signal over time (rise of the edge) provides information about the direction of rotation of the dosing knob.

Another conventional approach is based on a level measurement with case differentiation using additional sensor data. The click of the dose button is detected by a sensor, e.g. a microphone. In addition, a force sensor measures the resulting finger force during the injection. If the measured values exceed a specified threshold value, one click is counted. Click detection is only possible when a force (injection) is present. It is not possible to recognize the set dose before the injection.

Conventional injection devices are still subject to tolerances. Furthermore, the application of the drug is very individual. Therefore, the level, the slope, the click duration and the click sequence vary greatly. Only a few characteristic elements of the edge signal are evaluated. This leads to errors and a correction or confirmation of the recognized dose by the patient is necessary.

Out US 2018/0 043 097 A1 and US 2017/0 259 015 A1 Injection devices are also known which perform distance detection based on skin contact sensors.

It is an object of a medical application device to provide a detection structure for a medical application device and a method for calibrating the same that reduces or eliminates one or more of the aforementioned problems. For example, one task is to determine the actual amount of a drug that is being applied to a target tissue. As an example, how much insulin is actually injected into the target tissue with a pre-filled pen.

In one aspect, a medical application device for administering a liquid medicament having the features according to claim 1 is provided.

This enables a higher recognition rate of the user actions of the application device, for example the recognition of the correspondence of a user activity with a predetermined usage profile or profile. A predetermined usage profile can be, for example, priming an injection device, in which the injection device is held vertically upwards with the needle and a small amount of liquid medicament is dispersed. Alternatively or additionally, simple and safe operation of the application device or administration of a dose of the medicament can be made possible.

A user activity of the application device is illustrated by means of a distance detection (by means of the distance detection device), a position or inertial detection (by means of the position detection device) and a dose detection or by means of a force and / or torque sensor (by means of the Dosing detection device) recognized. The values acquired by means of the acquisition devices (distance, position, dose / dose delivery) can be evaluated using machine learning algorithms, which results in a very high level of reliability in recognizing user activities.

The distance detection device can clearly be a distance sensor that is located near the application structure, for example a needle of a syringe, and detects the distance between the needle tip or another predefined location of the application device and tissue that the needle tip is intended to puncture. If the dose of drug is delivered and the distance obtained indicates that the tip of the needle punctured the tissue, it can be assumed that the drug was injected into the tissue. However, if no distance or an “infinite” distance can be determined during the administration of the dose, for example during a priming, it can be assumed that the needle tip did not puncture the tissue and thus effectively no dose of the drug was administered. When priming, the syringe is usually held vertically with the needle tip pointing upwards and a small amount of medication is dispersed in order to remove air bubbles or air inclusions from the syringe and / or the needle.

The distance detection device is, for example, an optical transceiver, a time-of-flight sensor or an infrared sensor, which measures the distance to the target tissue at certain points. Alternative examples not according to the invention include a capacitive sensor or a mechanical sensor, for example a mechanical button at an outer end of the application device, for example a tip of the application device.

In one embodiment, the distance detection device can have a distance sensor which is offset from the longitudinal axis of the syringe, for example in a range from approximately 5 mm to approximately 20 mm, for example in a range from 10 mm to 15 mm, offset parallel to the longitudinal axis. The optical axis or detection axis of the distance sensor and the longitudinal axis of the application device, for example the longitudinal axis of the syringe, can span an angle, for example in a range from approximately 0 ° to approximately 45 °, for example in the range between 0 ° to 30 °. By means of the angle, the sensor of the distance detection device can be focused, for example, on the tip of the needle of the application structure or another area of the needle or in front of the tip of the needle. This enables reliable detection of whether the target tissue has been punctured and thus a reliable detection of whether or that a dose of the drug has been administered.

In various embodiments, the dose detection device can have a force sensor and / or a torque sensor, for example in the case of a mechanical dosing device. The dose detection device detects, for example, the forces and torques acting before and during the application of the application device, for example during the administration of the dose of the drug, for example during the actuation of the dosing button of an application device.

In various embodiments, the position detection device can have an inertial sensor. The inertial sensor can consist of or have an acceleration sensor and a gyroscope. The orientation of the application device in an environment external to the application device can be detected by means of the inertial sensor. Alternatively or in addition, vibrations of the application devices, for example when the dosing button is actuated, can be determined. This enables, for example, an alignment of the application device to be determined in an environment external to the application device. As an example, the administration of the dose into a tissue can be determined if the application device is held vertically downwards during the administration of the dose and a priming of the application device can be determined if the application device is held vertically upwards during the administration of the dose. In various embodiments, the acceleration sensor can be used to determine that a threshold value has been exceeded, for example to monitor a fall of the application device (fall event) in order to detect possible damage and / or misalignment of the application device.

In various embodiments, the acquired values of the various acquisition devices and an improved algorithm with the aid of machine learning for recognizing the set dose (before the injection) and the dose actually injected can enable a more precise acquisition of the administered dose of a drug. This makes it possible to monitor or control drug intake, for example for dementia Patients whether, when and in what amount a drug was taken.

In a further aspect, a detection structure for a medical application device for administering a liquid medicament having the features of claim 11 is provided.

The detection structure can be attached to the application device in a material, non-positive and / or form-fitting manner. The application device can, for example, be a disposable syringe. The detection structure can be set up so that it surrounds the application device completely or essentially completely (for example except for the application structure).

The detection structure can be set up in such a way that important information from the application device, for example a label on a disposable syringe, remains visible. The detection structure can be set up with respect to predetermined application devices in such a way that the detection structure can be attached to the application device in such a way that, for example, forces or torques acting on the dosing button can be detected with the dose detection device.

In a further aspect, a method for calibrating a medical application device having the features according to claim 15 is provided.

In a further aspect, a method for calibrating a detection structure having the features according to claim 16 is provided.

A user of the application device can comfortably train or calibrate this or the detection structure in order to adapt it to his habits. To train the static model, the data can be transferred to an external, powerful end device, such as a smartphone. The machine learning algorithms can be used, for example, to determine both the dose set on the application device (before the injection) and the dose actually injected (during the injection). It is also possible to identify other user actions, e.g. priming (removing air pockets from a syringe and / or cannula).

In a further aspect, a method for operating a medical application device having the features according to claim 18 is provided.

Developments are presented in the dependent claims.

Exemplary embodiments are shown in the figures and are explained in more detail below.

• 1A und 1B schematische medizinische Applikationsvorrichtungen gemäß verschiedenen Ausführungsformen;
• 2 eine schematische Ausführungsform einer Injektionsvorrichtung als medizinische Applikationsvorrichtungen gemäß verschiedenen Ausführungsformen;
• 3 ein Ablaufdiagram eines Verfahrens zum Kalibrieren einer Erfassungsstruktur bzw. einer medizinischen Applikationsvorrichtung gemäß verschiedenen Ausführungsformen;
• 4-7 Mess-Diagramme eines Erprobungsbeispiels einer medizinischen Applikationsvorrichtung gemäß verschiedenen Ausführungsbeispielen; und
• 8-9 Ablaufdiagramme eines Erprobungsbeispiels eines Verfahrens zum Kalibrieren einer Erfassungsstruktur bzw. einer medizinischen Applikationsvorrichtung gemäß verschiedenen Ausführungsformen gemäß verschiedenen Ausführungsbeispielen.

Show it

• 1A and 1B schematic medical application devices according to various embodiments;
• 2 a schematic embodiment of an injection device as medical application devices according to various embodiments;
• 3 a flowchart of a method for calibrating a detection structure or a medical application device according to various embodiments;
• 4-7 Measurement diagrams of a test example of a medical application device according to various exemplary embodiments; and
• 8-9 Flowcharts of a test example of a method for calibrating a detection structure or a medical application device in accordance with various embodiments in accordance with various exemplary embodiments.

In the following detailed description, reference is made to the accompanying drawings, which form a part of the specification, and in which there is shown, for purposes of illustration, specific embodiments in which the invention may be practiced. It goes without saying that other embodiments can be used and structural or logical changes can be made without departing from the scope of protection of the present invention. It goes without saying that the features of the various exemplary embodiments described herein can be combined with one another, unless specifically stated otherwise. The following description is therefore not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

In the context of this description, a usage profile or a profile of a predetermined user activity (also referred to as user action or operating state) of an (initially indeterminate or abstract) user of the application device or the detection structure with an application device. A profile can be dependent on the specific design of the application device. For example, an injection device can have different profiles than a transdermal patch. A profile can be, for example: a priming of the application device, a dose reduction, a dose increase, a dose administration, a fall event, a battery change, a Filling the reservoir with a liquid drug, recording the quality and / or quantity of a predetermined liquid drug, changing and / or changing the application structure, etc.

A profile can be mapped by means of a model that is based on recorded values of the recording devices. The profile can be assigned to a specific user by means of the profile, for example priming an injection device, and the corresponding model for the profile, for example a statistical evaluation of the values of the individual recording devices recorded during the priming in the calibration process. In other words: a first user can have a different model in a profile (for example priming) than a second user. The different models or the corresponding recorded values are based on the fact that the second user operates the application device differently than the first user - as an example: left-handed compared to right-handed; Users with muscle tremors, etc.

A model can be provided for each profile. The model clearly describes the recorded values of the recording devices for a specific profile. The recorded values of a profile can be correlated with one another. For example, the detected distance during an injection can be correlated with the position of the injection device - as an example: the detected distance can increase or decrease if the injection device is not held exactly vertically during the dose administration.

If at a later point in time, while a user is using the application device, a match between the values recorded by means of the recording devices and a model can be determined, the corresponding profile, i.e. the user activity, can be carried out without further user input. In other words: by means of the model, the user activity of a specific user can be assigned to a predetermined profile. A profile based on the acquired values of the acquisition device and the model can thus be acquired without additional user input. As an example, a priming of an injection device can be automatically recognized based on the model corresponding to the priming, for example values of the acquisition device acquired during the calibration process in the “priming” profile. The recorded values of the “priming” model correspond, for example, to: the application structure is oriented vertically upwards and a low dose of drug is administered. The alignment of the application device can be detected by means of the position detection device (for example by means of an inertial sensor) and the distance detection device (no detected distance or “infinite distance”). The dose delivered can be detected by means of the dose detection device. “Automatically recognized” in this sense means that the user does not necessarily have to enter on the injection device that, for example, priming is or should be carried out.

By means of the profile corresponding to a user activity, for example the dose of the liquid medicament administered during priming can be automatically recognized as a “non-injected dose” or “not administered dose” without further user input being required. In a similar way, other profiles or predetermined user activities can be recognized automatically. In this way, for example, more precise monitoring of the drug administration can be made possible.

However, profiles can also be provided which are assigned to multiple users or not just to a specific user, for example a fall event of the application device. In the event of a fall, the reservoir can be damaged and / or the adjustment of the dosing device can be changed. The fall event can be detected, for example, by means of an acceleration sensor of the position detection device. It can be irrelevant how (assignment to a specific user) the fall event was caused.

1A illustrates a schematic view of a medical application device 100 for the administration of a liquid medicament according to various embodiments.

The medical application device 100 has a housing in various embodiments 102 , a reservoir 104 , an application structure 106 , a dosing device 108 , a distance detecting device 114 , a position detecting device 112 , a dose detection device 110 , a memory 122 , and (at least) one processor 120 on.

The reservoir 104 is set up to receive the liquid medicine. The reservoir 104 can be an ampoule, for example.

The application structure 106 is set up to remove the liquid medicine from the reservoir 104 in an environment external to the application device 116 to administer. The application structure 106 can for example be a needle, a cannula or an atomizer (for aerosol generation).

In various embodiments, the application structure 106 be set up for administering the dose in a cavity. In other words: the medical application device can be set up as an instillation device. For example, the application structure 106 with regard to the diameter of the opening of a cannula or needle and / or the speed / acceleration of the dose delivery with regard to the surface tension of the drug; and / or an aerosol formation structure, for example as a metered dose inhaler.

In various embodiments, the medical application device can 100 be set up as a transdermal patch or injector, for example as a hormone or nicotine patch.

The dosing device 108 is with the reservoir 104 coupled and arranged to maintain a dose of the liquid drug in the reservoir 104 set that in an application of the medical application device 100 is administrable, and for administering the dose. The dosing device 108 can for example have a conventional mechanical mechanism, for example a push button.

The distance detection device 114 is set up a distance 118 between the application structure 106 and a target tissue 116 capture. The distance detection device 114 can for example have an optical transceiver, an optical sensor, an infrared sensor. Optionally, the distance detection device 114 have a capacitive sensor and / or a mechanical button for distance detection.

The position detection device 112 is set up a location 130 the medical application device 100 with regard to the environment external to the application device 116 capture.

The dose detection device 110 is set up to record the dose of the liquid drug to be administered and the administration of the dose. The dose detection device 110 can with a mechanical metering device 108 for example have a force sensor and / or a torque sensor. Alternatively, the dose detection device 110 have a spring and a button. When force is applied to the dosing device 108 can be a relative movement between dose detection device 110 and housing are formed. This can be done, for example, by means of a button on the dose recording device 110 are recorded.

The processor 120 is with the distance detecting device 114 , the position detection device 112 and / or the dose detection device 110 communicatively coupled (in 1A illustrated by the dashed line).

The memory 122 may contain instructions that, when sent by the at least one processor 120 be executed, the at least one processor 120 cause the situation 130 the medical application device 100 by means of the position detection device 112 capture; the distance 118 between the application structure 106 and the environment external to the application device 116 by means of the distance detecting device 114 capture; the set dose by means of the dose detection device 110 capture; and / or to record the administration of the set dose. Furthermore, the processor can be made to determine the administered dose and to provide an output based on the determined dose to a device external to the application device.

In various embodiments, a communication device can be provided which is set up to provide one or more of the acquired values from the group: the by means of the position acquisition device to an application device-external device 112 recorded situation 130 the medical application device; by means of the distance detection device 114 detected distance 118 between the application structure 106 and the environment external to the application device 116 ; by means of the dose detection device 110 recorded set dose; and / or the administration of the set dose.

In various embodiments, a fastening structure can be provided which is set up, the medical application device 100 to fix on or in an organic tissue, for example as a transdermal applicator.

In various embodiments, the reservoir 104 , the dosing device 108 , the distance detection device 114 , the position detection device 112 and the dose detection device 110 at least partially in the housing 102 be integrated.

In various embodiments, an energy supply structure can be provided which is set up, at least the distance detection device 114 , the position detection device 112 and the dose detection device 110 to be supplied with electrical energy, the energy supply structure in the housing 102 is integrated.

1B Figure 11 illustrates a schematic view of a sensing structure 150 for a medical application device 160 for the administration of a liquid medicament according to various embodiments.

In contrast to the embodiment described in 1A As illustrated, in various embodiments the sensing structure 150 a recording structure 140 have, which is set up, the medical application device 160 to be included in this way (in 1B by means of the arrow 170 illustrates) that the acquisition structure 150 on the application device 160 is fixable (in 1B by means of the arrow 172 illustrated). In this embodiment, the distance detecting device 114 be set up a distance 118 between the acquisition structure 150 and the environment external to the acquisition structure 116 capture. The position detection device 112 can be set up a location 130 the acquisition structure 150 with regard to the environment external to the acquisition structure 116 capture. The instructions in memory 122 can if they are from the at least one processor 120 be executed, the at least one processor 120 cause the situation 130 the acquisition structure 150 by means of the position detection device 112 capture; the distance 118 between the acquisition structure 150 and the environment external to the acquisition structure 116 by means of the distance detecting device 114 capture. The communication device can be set up to provide one or more of the acquired values from the group: the by means of the position acquisition device to a device external to the acquisition structure 112 recorded situation 130 the acquisition structure 150 ; by means of the distance detection device 114 detected distance 118 between the acquisition structure 150 and the environment external to the acquisition structure 116 .

In various embodiments, the application structure 106 be arranged to puncture an organic tissue for administration of the dose. In other words: the medical application device 100 can be set up as an injection device. One embodiment of an application device 100 as an injection device is shown schematically in 2 illustrated.

The injection device can have parts which are set up as a single-use product with a multiple-use detection structure 150 for example a disposable syringe 160 surrounds ( 1B) , or the injection device can be set up as a multiple product ( 1A) . The distance detection device 114 can be set up at a distance, for example in a range between 5 mm and 20 mm, and / or at an angle, for example in a range between 0 ° and 45 °, to the longitudinal axis. The dosing device 108 can be a conventional mechanical dosing unit with a rotary and push button. The dose detection device 110 can with the application device 104 be coupled, for example such that the dose detection device 110 Vibrations and / or clicking noises of the application device 104 or the dosing device 108 through the application device 104 can capture. The position detection device 112 can be set up the position of the application device 100 in an environment external to the application device 130 capture. For example, by means of the position detection device 112 be determined whether the application device 100 with the application structure 106 upwards or with the application structure 106 is held down.

3 Figure 11 illustrates a flow diagram of a method 300 for calibrating a medical application device ( 1A) or a recording structure ( 1B) . One embodiment of the method is shown in FIG 8th illustrated.

The procedure 300 indicates: Select 302 a profile that corresponds to a predetermined operating state of the medical application device 100 is associated from a group of predetermined operating states.

The selection can take place in a computer program product that is stored on the application device or the acquisition structure or on a device external to this, see for example 802 in FIG 8th .

The profile can, for example, be one of: priming, increasing dose, reducing dose, administering dose, fall event. The profile or the operating state can correspond to a predetermined user activity, see, for example, 804 in FIG 8th .

The procedure 300 can also execute 304 of the predetermined operating state with the medical application device. Depending on the profile, this may require the application device to be picked up by the user by hand, see, for example, 806 in FIG 8th .

The method can also include detection 306 have at least one value (depending on the profile to be calibrated) based on: the location 130 the medical application device 100 by means of the position detection device 112 ; the distance between the medical application device 100 to the application device-external environment 116 by means of the distance detecting device 114 ; the set dose using the dose Detection device 110 and / or the dose delivered by means of the dose detection device 110 .

The procedure 300 can also save 308 of the at least one recorded value in the profile, for example in the memory of the application device and / or detection structure. This can require that the user activity or the corresponding operating state associated with the profile be carried out, see for example 808 in FIG 8th . The at least one recorded value can be stored in the application device or the recording structure and / or transmitted to the external device, see 808, 810 in 8th .

If the at least one recorded value is transmitted to an external device, a confirmation of the transmitted values can optionally be provided, see for example 812 in 8th . Alternatively, the at least one recorded value can be confirmed on the application device or the recording structure.

Based on the at least one recorded value, a model corresponding to the profile can be determined or calculated 308. In the model, a correlation between several recorded values and / or a statistical or systematic variance or deviation of the individual recorded values can be determined are associated with the profile.

The model can be determined, for example calculated, in the application device or the acquisition structure and / or in the external device, see for example 814 in 8th .

Optionally, the determined model can be stored in the external device and / or transmitted to the application device or the acquisition structure and stored locally, see for example 816 or. 818 in 8th .

The procedure 300 by means of a computer program product that is stored on an application device-external device or a detection structure-external device. The application device or the acquisition structure can be or can be communicatively coupled to the device in order to transmit the values acquired by means of the acquisition structure to the device. The selection of the profile and / or the determination of the model can be carried out on the external device. The model that corresponds to the profile can be transmitted from the external device to the application device or the acquisition structure.

4th , 5 , 6th and 7th illustrate measurement diagrams of a test example of a medical application device according to various exemplary embodiments. The recorded values 400 , 500 , 600 , 700 vibrations in the x-direction 410, y-direction 412 and z-direction 414 in the application device are detected by means of the position detection device, for example in the form of an inertial sensor. The acceleration is illustrated 404 (as a multiple of g) as a function of time 402 (in seconds). In 4th the setting is illustrated 406 of 20 units of a drug (here insulin) and dispensing 408 of the previously set 20 units. 5 illustrates the values detected by means of the position detection device 500 during shooting 502 , 504 of the dose button 108 in the plus direction (turn the dose button in the positive direction to increase the set dose). 6th illustrates the values detected by means of the position detection device 600 during shooting 602 , 604 of the dose button 108 in the minus direction (turn the dose button in the negative direction to reduce the set dose). 7th illustrates the recorded values 700 while pressing the dose button 108 and the delivery of two doses 702 , 704 the medicine (press the injection button and dispense the dose). Out 5 and 6th it can be seen that the directions of rotation of the dosing button ( 108 ) from the recorded values 500 , 600 are distinguishable from each other. It can also be seen that drug delivery ( 7th ) from the dose setting ( 5 and 6th ) is distinguishable. Using suitable data processing or a suitable algorithm, for example by means of machine learning, the status or the operation of the application device can be determined 100 be determined.

Different states of the application device 100 are dependent on the patient's habits and can in principle be detected. For example, removing air bubbles (priming). The application device is mainly held vertically upwards and a small dose is dispensed. When setting a dose, the application device is mainly held horizontally. When administering a dose, the application device is mainly held vertically downwards. The needle, for example the application structure, is left in the target tissue for a period of time, for example 10 seconds. The application structure is held still during the dose administration. With a filter, relevant information can be determined from the values detected by means of the position detection device. The orientation of the application device can be included in the frequency range from 0 Hz to 1 Hz, for example for priming. Based on the frequency components in the range from approximately 10 Hz to 100 Hz recognizable which actions the user is doing on the rotary knob 108 performs.

Out 4th until 7th it can also be seen that the signals for every action (profile) on the application device follow a complex pattern. Conventional, simple analysis methods for signal recognition, for example edge rise, duration, threshold value recognition, cross-correlation or dynamic time normalization (dynamic time warping), can be highly error-prone or only provide limited accuracy. However, by means of machine learning for pattern recognition or for click recognition, the different states can be classified, trained and recognized more reliably.

With regard to the use of machine learning for status monitoring in injection devices, the following basic work steps can result: storage of recorded values while the application device is in use; Classification of the recorded values and subdivision into separate data sets (e.g. plus, minus, injection); Creation (training or calibration) of a static model on the basis of the data sets; Implementation and application of the static model.

For a high accuracy of the machine learning algorithm, an adaptation (training) of the predefined static model to the individual handling by the patient can be helpful. This may require an external, powerful device, e.g. a mobile device or PC. The powerful device can use the recorded values to determine an individually adapted static model (for the respective user of the application device).

8th until 9 illustrate flowcharts of a test example of a method for calibrating a detection structure or a medical application device in accordance with various embodiments in accordance with various exemplary embodiments.

A training method or calibration method 800 can have the following steps: a start 802 a training program on an external device, for example on a smartphone. The procedure 800 can be a picking 804 the class of a user action to be trained, for example a dose selection (plus). The procedure 800 can still record 806 the application device with the detection structure. The procedure 800 can still perform 808 the selected action with the application device and a storage of the recorded values in the application device. The procedure 800 can also store the application device and transmit 810 of the at least one recorded value to the external device. Dropping can indicate hibernation or termination of user activity. The procedure 800 can still confirm 812 which have data read into the external device for the training. The procedure 800 can still recalculate 814 a statistical model on the external device based on the transmitted data. The procedure 800 can still have a memory 816 of the new statistical model on the external device. The procedure 800 can still transmit 818 have the new statistical model on the application device.

In various embodiments, a method 900 provided for operating a medical application device. In 9 One embodiment of the method is illustrated and described in greater detail below. The medical application device can be set up according to a described embodiment.

The procedure 900 can determine 902 , 904 , 906 at least one recorded value relating to an operating state of the metering device 108 corresponds, by means of the dose detection device 110 wherein the operating state corresponds to setting a dose and / or administering the dose; Detect 908 , 910 at least one value that corresponds to the distance 118 corresponds by means of the distance detecting device 114 ; and determine 912 , 914 at least one value related to the location 130 corresponds, by means of the position detection device 112 exhibit.

The procedure 900 may include determining a profile from at least a first profile and a second profile, for example from a group or a plurality of different profiles. The profiles can correspond to different user activities and / or to different users. The first profile can be associated with a first user activity and the second profile can be associated with a second user activity. The first profile can have a first model that contains statistical values for the recorded values that correspond to the first user activity. The second profile can have a second model that contains statistical values for the recorded values that correspond to the second user activity. The profile can be determined based on a comparison of the recorded values with the first model and the second model.

The procedure 900 can also provide an output, for example a data signal, an acoustic and / or optical signal or have something similar based on the determined profile.

The output, for example in the form of a data signal, can be transmitted to an external device. In the case of insulin as a liquid medicament, the external device can be, for example, a diabetes management system. The device can have a computer program product which is set up to monitor the dose administration. The received output can be compared in the device to a predetermined dose administration of the liquid medicament.

With the diabetes management system, the amount of insulin to be injected can be clearly calculated and then checked whether it has been applied in full.

In one embodiment, the method 900 for monitoring the injection process and recognizing the set or injected dose according to the in 9 the illustrated schedule. The procedure 900 can have the following steps: readout 902 the dose detection device 110 , for example a torque and / or force sensor; Check 904 whether the detected force exceeds a threshold value - if so ( 904 - yes) - read out 908 the distance detection device 114 , for example a distance sensor. If the detected distance is greater than a threshold value ( 910 - no), the dose recording device can 110 can be read out again. If the detected distance is less than a threshold value ( 910 - yes), the position detection device can 112 , for example an inertial sensor, read out 912 and the machine learning algorithm 916 to be started. Should an injection click by pressing the dose button 108 to be recorded ( 918 - yes), the counter of the administered dose can be increased 922 and the dose to be administered 926 . Should no injection click be detected ( 918 - no), the dose recording device can 110 can be read out again. Should the administration be finished ( 930 - yes), the procedure is over. If the administration has not ended ( 930 - no), the dose recording device can 110 can be read out again.

If the detected force does not exceed the threshold value ( 904 - no), it can be checked whether the torque exceeds a threshold value 906 . If the threshold value is not exceeded ( 906 - no), the dose recording device can 110 can be read out again. If the threshold value is exceeded ( 906 - yes), the position detection device can 110 are read out and the machine learning algorithm 916 to be started. Should a dose setting click by turning (plus or minus) the dose knob 108 to be recorded ( 920 - yes), the dose to be administered can be calculated 924 and the dose to be administered can be dispensed 928 . Should a dose setting click no turning (plus or minus) the dose knob 108 to be recorded ( 920 - no), the dose recording device can 110 can be read out again.

In the following, various examples are described which relate to what is described herein and shown in the figures.

Example 1 is a medical application device for administering a liquid drug. The medical application device has: a reservoir which is set up to receive the liquid medicament; an application structure which is set up to administer the liquid medicament from the reservoir into an environment external to the application device; a dosing device which is coupled to the reservoir and is set up to set a dose of the liquid medicament in the reservoir, which dose can be administered in one application of the medical application device, and for administering the dose; a distance detection device which has an optical transceiver which is set up to detect a distance between the application structure and the environment external to the application device; a position detection device which is set up to detect a position of the medical application device with respect to the environment external to the application device; and a dose detection device which is set up to detect the dose of the liquid medicament to be administered and the administration of the dose.

In example 2, example 1 can optionally further include: a memory, and at least one processor, the processor being communicatively coupled to the distance detection device, the position detection device and / or the dose detection device.

In example 3, example 2 can optionally have that the memory contains instructions which, when they are executed by the at least one processor, cause the at least one processor to: detect the position of the medical application device by means of the position detection device; to detect the distance between the application structure and the environment external to the application device by means of the distance detection device; to detect the set dose by means of the dose detection device; and / or to record the administration of the set dose. In example 4, example 2 or 3 can optionally include that the memory contains instructions that, when executed by the at least one processor, the at least one Cause processor to: determine the administered dose and provide an output based on the determined dose to a device external to the application device.

In example 5, one of examples 1 to 4 can optionally have a communication device that is set up to provide one or more of the recorded values from the group: the position of the medical application device detected by means of the position detection device; the distance between the application structure and the environment external to the application device detected by means of the distance detection device; the set dose detected by means of the dose detection device; and / or the administration of the set dose.

In example 6, one of examples 1 to 5 can optionally have a fastening structure which is set up to fix the medical application device on or in an organic tissue.

In example 7, one of examples 1 to 6 can furthermore have a housing, the reservoir, the dosing device, the distance detection device, the position detection device and the dose detection device being at least partially integrated in the housing.

In example 8, example 7 can furthermore have an energy supply structure which is set up to supply at least the distance detection device, the position detection device and the dose detection device with electrical energy, the energy supply structure being integrated in the housing.

In example 9, one of examples 1 to 8 can optionally have that the application structure is set up to puncture an organic tissue for administering the dose. In example 10, one of examples 1 to 8 can optionally have the application structure set up for administering the dose in a cavity.

In example 11, one of examples 1 to 8 can optionally be set up as a transdermal patch.

Example 12 is a detection structure for a medical application device for administering a liquid drug. The medical application device has: a reservoir which is set up to receive the liquid drug and an application structure which is set up to administer the liquid drug from the reservoir into an environment external to the application device. The detection structure has: a receiving structure which is set up to receive the medical application device in such a way that the detection structure can be fixed on the application device; a dosing device which can be coupled to the reservoir and is set up to set a dose of the liquid medicament in the reservoir which can be administered in one application of the medical application device; a distance detection device having an optical transceiver which is configured to detect a distance between the detection structure and the environment outside the detection structure; a position detection device which is set up to detect a position of the detection structure with respect to the environment external to the detection structure; a dose detection device which is set up to detect the dose of the liquid medicament to be administered and the administration of the dose.

In example 13, example 12 can further optionally have a memory and at least one processor, the processor being communicatively coupled to the distance detection device, the position detection device and / or the dose detection device.

In example 14, example 13 can optionally have that the memory contains instructions which, when executed by the at least one processor, cause the at least one processor to: detect the position of the detection structure by means of the position detection device; to detect the distance between the detection structure and the environment external to the detection structure by means of the distance detection device; to detect the set dose by means of the dose detection device; and / or to record the administration of the set dose.

In example 15, example 13 or 14 can optionally include the memory containing instructions that, when executed by the at least one processor, cause the at least one processor to: determine the dose administered, and output based on the determined To provide dose to a device external to the detection structure. In example 16, one of examples 12 to 15 can optionally have a communication device which is set up to provide one or more of the detected values from the group: the position of the detection structure detected by means of the position detection device to a device external to the detection structure; the distance between the detection structure and the environment external to the detection structure detected by means of the distance detection device; the set dose detected by means of the dose detection device; and / or the recorded administration of the set dose.

In example 17, one of examples 12 to 16 can furthermore optionally have a fastening structure which is set up to fix the medical application device and / or the acquisition structure on or in an organic tissue.

In example 18, one of examples 12 to 17 can further optionally have a power supply structure which is set up to supply at least the distance detection device, the position detection device and the dose detection device with electrical energy, and a housing, wherein the distance detection device , the position detection device, the dose detection device and the energy supply structure are at least partially integrated in the housing.

Example 19 is a method of calibrating a medical application device. The medical application device can be set up according to one of Examples 1 to 11. The method comprises: selecting a profile that is associated with a predetermined operating state of the medical application device from a group of predetermined operating states; Executing the predetermined operating state with the medical application device; Detecting at least one value based on: the position of the medical application device by means of the position detection device; the distance between the medical application device and the environment external to the application device by means of the distance detection device; the set dose by means of the dose detection device and / or the dose dispensed by means of the dose detection device; Determining a statistical model based on the at least one recorded value, the model corresponding to the selected profile; and storing the model in the application device.

Example 20 is a method of calibrating a sensing structure. The detection structure can be set up in accordance with one of Examples 12 to 17. The method comprises: selecting a profile which is associated with a predetermined operating state of the detection structure from a group of predetermined operating states; Executing the predetermined operating state with the detection structure; Detecting at least one value based on: the position of the detection structure by means of the position detection device; the distance between the detection structure and the environment external to the detection structure by means of the distance detection device; the set dose by means of the dose detection device and / or the dose dispensed by means of the dose detection device; and determining a statistical model based on the at least one recorded value, the model corresponding to the selected profile; and storing the model in the acquisition structure.

In example 21, one of examples 19 or 20 can optionally have the method being carried out by means of a computer program product that is stored on a device external to the application device or a device external to the detection structure, the application device or the detection structure also being carried out the device is communicatively coupled in order to transmit the values detected by means of the detection structure to the device; and wherein the model that corresponds to the profile is transmitted to the application device or the acquisition structure.

Example 22 is a method for operating a medical application device according to one of Examples 1 to 11. The method comprises: determining at least one recorded value, which corresponds to an operating state of the dosing device, by means of the dose detection device, the operating state leading to a setting of a Dose and / or an administration of the dose corresponds; Determining at least one value which corresponds to the distance by means of the distance detection device; Determining at least one value which corresponds to the position by means of the position detection device; Determining a profile from at least a first profile and a second profile, the first profile being associated with a first user activity and the second profile being associated with a second user activity, the first profile having a first model that contains statistical values for the recorded values which correspond to the first user activity, and the second profile has a second model that contains statistical values for the recorded values that correspond to the second user activity, and wherein the profile is based on a comparison of the recorded values with the first model and the second model is determined; and providing an output based on the determined profile.

In example 23, example 22 can optionally include that the output is transmitted to an external device, the device comprising a computer program product that is configured to monitor the dose administration; and based on the received output being compared to a predetermined dose administration of the liquid medicament by the external device.

In Example 24, either of Examples 22 or 23 may optionally include that the liquid drug is insulin.

It goes without saying that functions, algorithms, etc. which are described herein with reference to a device can also be implemented in a method in the same or a similar manner, and vice versa.

Claims (20)

Medical application device (100) for administering a liquid medicament, the medical application device (100) having: • a reservoir (104) which is arranged to hold the liquid medicament; • an application structure (106) which is set up to administer the liquid medicament from the reservoir (104) into an environment (116) external to the application device; • a dosing device (108) which is coupled to the reservoir (104) and is set up to set a dose of the liquid medicament in the reservoir (104) which can be administered in one application of the medical application device (100) and for administering the Dose; • a distance detection device (114) which has an optical transceiver which is set up to detect a distance (118) between the application structure (106) and the environment (116) external to the application device; A position detection device (112) which is set up to detect a position (130) of the medical application device (100) with respect to the environment (116) external to the application device; and • a dose detection device (110) which is set up to detect the dose of the liquid medicament to be administered and the administration of the dose. Medical application device (100) according to Claim 1 , further comprising: • a memory (122), and • at least one processor (120), wherein the processor (120) with the distance detection device (114), the position detection device (112) and / or the dose detection device ( 110) is communicatively coupled. Medical application device (100) according to Claim 2 wherein the memory (122) contains instructions which, when they are executed by the at least one processor (120), cause the at least one processor (120) to do the following: the location (130) of the medical application device (100) by means of the location - detecting device (112) to detect; • to detect the distance (118) between the application structure (106) and the environment (116) external to the application device by means of the distance detection device (114); • to detect the set dose by means of the dose detection device (110); and / or • to record the administration of the set dose; and • to determine the administered dose, and • to provide an output based on the determined dose to a device external to the application device. Medical application device (100) according to one of the Claims 1 until 3 , further comprising a communication device which is set up to provide one or more of the recorded values from the group to a device external to the application device: the position (130) of the medical application device detected by means of the position detection device (112); The distance (118) between the application structure (106) and the environment (116) external to the application device, detected by means of the distance-detecting device (114); • the set dose detected by means of the dose detection device (110); and / or • the administration of the set dose. Medical application device (100) according to one of the Claims 1 until 4th , wherein the application structure (106) has a needle and the optical transceiver of the distance detection device (114) is focused on a region of the needle or in front of the tip of the needle. Medical application device (100) according to one of the Claims 1 until 5 , further comprising a housing (102), wherein the reservoir (104), the dosing device (108), the distance detection device (114), the position detection device (112) and the dose detection device (110) are at least partially in the housing (102) are integrated. Medical application device (100) according to Claim 6 , further comprising: an energy supply structure which is set up to supply at least the distance detection device (114), the position detection device (112) and the dose detection device (110) with electrical energy, wherein the energy supply structure in the housing (102) is integrated. Medical application device (100) according to one of the Claims 1 until 7th , wherein the application structure (106) is set up to puncture an organic tissue for administering the dose. Medical application device (100) according to one of the Claims 1 until 7th , wherein the application structure (106) is set up for administering the dose in a cavity. Medical application device (100) according to one of the Claims 1 until 9 , set up as a transdermal patch. Detection structure (150) for a medical application device (160) for administering a liquid medicament, the medical application device (160) having: • a reservoir (104) which is arranged to hold the liquid medicament; • an application structure (106) which is set up to administer the liquid medicament from the reservoir (104) into an environment (116) external to the application device; comprising the sensing structure (150): • a receiving structure (140) which is set up to receive the medical application device (160) in such a way that the detection structure (150) can be fixed on the application device (160); • a dosing device (108) which can be coupled to the reservoir (104) and is set up to set a dose of the liquid medicament in the reservoir (104) which can be administered in one application of the medical application device (100); • a distance detection device (114) having an optical transceiver which is set up to detect a distance (118) between the detection structure (150) and the environment (116) external to the detection structure; • a position detection device (112) which is set up to detect a position (130) of the detection structure (150) with respect to the environment (116) external to the detection structure; • a dose detection device (110) which is set up to detect the dose of the liquid medicament to be administered and the administration of the dose. Detection structure (150) according to Claim 11 , further comprising: • at least one processor (120), wherein the processor (120) is communicatively coupled to the distance detection device (114), the position detection device (112) and / or the dose detection device (110); and • a memory (122), the memory (122) containing instructions which, when executed by the at least one processor (120), cause the at least one processor (120) to: • the location (130) of the sensing structure (150) to be detected by means of the position detection device (112); • to detect the distance (118) between the detection structure (150) and the environment (116) external to the detection structure by means of the distance detection device (114); • to detect the set dose by means of the dose detection device (110); • record the administration of the set dose; • to determine the administered dose, • to provide an output based on the determined dose to a device external to the detection structure. Detection structure (150) according to one of the Claims 11 until 12th , further comprising a communication device which is set up to provide one or more of the acquired values from the group to a device external to the acquisition structure: the position (130) of the acquisition structure (150) acquired by means of the position acquisition device (112); • the distance (118) between the detection structure (150) and the environment (116) external to the detection structure, detected by means of the distance detection device (114); • the set dose detected by means of the dose detection device (110); and / or • the recorded administration of the set dose. Detection structure (150) according to one of the Claims 11 until 13th , further comprising • a power supply structure which is set up to supply at least the distance detection device (114), the position detection device (112) and the dose detection device (110) with electrical energy, and • a housing (102), wherein the distance detection device (114), the position detection device (112), the dose detection device (110) and the energy supply structure are at least partially integrated in the housing (102). Method (300) for calibrating a medical application device, the medical application device (100) according to one of the Claims 1 until 10 , the method (300) comprising: ■ selecting (302, 804) a profile associated with a predetermined operating state of the detection structure (150) from a group of predetermined operating states; ■ executing (304, 808) the predetermined operating state with the detection structure (150); Acquisition (306, 808) of at least one value based on: • the position (130) of the acquisition structure by means of the position acquisition device (112); • the distance between the detection structure and the environment (116) external to the detection structure by means of the distance detection device (114); • the set dose by means of the dose detection device (110) and / or • the dose dispensed by means of the dose detection device (110); Determining (308, 816) a statistical model based on the at least one recorded value, the model corresponding to the selected profile; and ■ storing (818) the model in the application device. Method (300, 800) for calibrating a detection structure (150), the detection structure (150) according to one of the Claims 11 until 14th , the method comprising: selecting (302, 804) a profile associated with a predetermined operating state of the sensing structure (150) from a group of predetermined operating states; ■ executing (304, 808) the predetermined operating state with the detection structure (150); Acquisition (306, 808) of at least one value based on: • the position (130) of the acquisition structure by means of the position acquisition device (112); • the distance between the detection structure and the environment (116) external to the detection structure by means of the distance detection device (114); • the set dose by means of the dose detection device (110) and / or • the dose dispensed by means of the dose detection device (110); Determining (308, 816) a statistical model based on the at least one recorded value, the model corresponding to the selected profile; and ■ storing (818) the model in the acquisition structure. Procedure according to Claim 15 or 16 , wherein the method (300, 800) is carried out by means of a computer program product that is stored on an application device-external device or a detection structure-external device, the application device or the detection structure being communicatively coupled to the device in order to to transmit the values acquired by means of the acquisition structure to the device; and wherein the model that corresponds to the profile is transmitted to the application device or the acquisition structure. Method (900) for operating a medical application device, the medical application device (100) according to one of the Claims 1 until 10 , the method (900) comprising: determining (902, 904, 906) at least one recorded value, which corresponds to an operating state of the dosing device (108), by means of the dose detection device (110), the operating state being a setting of a dose and / or corresponds to an administration of the dose; • determining (908, 910) at least one value which corresponds to the distance (118) by means of the distance detection device (114); • determining (912, 914) at least one value which corresponds to the position (130) by means of the position detection device (112); • Determination of a profile from at least a first profile and a second profile, ■ wherein the first profile is associated with a first user activity and the second profile is associated with a second user activity, ■ wherein the first profile has a first model, the statistical values for contains the recorded values that correspond to the first user activity, and ■ the second profile has a second model that contains statistical values for the recorded values that correspond to the second user activity, and ■ wherein the profile is based on a comparison of the recorded values is determined with the first model and the second model; and ■ providing an output based on the determined profile. Procedure according to Claim 18 the output being communicated to an external device, the device comprising a computer program product configured to monitor dose administration; and based on the received output being compared to a predetermined dose administration of the liquid medicament by the external device. Procedure according to Claim 19 , where the liquid drug is insulin.

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