Determination of the usage status of a device for the single administration of a drug

Abstract

The invention relates to a device for the single administration of a drug, comprising a housing and a component movably arranged within the housing. During the complete administration of the drug, the movably arranged component moves from a first position relative to the housing to a second position relative to the housing, and during this change of position, it influences the amount of light from a light source reaching a light sensor. The sensor signal can be read via an electronic circuit or chip connected to the light sensor and comprising a passive data transmission unit.The invention further relates to a mobile device comprising an active data transmission unit for communication with the passive data transmission unit of the electronic circuit or chip, a user interface and / or a communication interface, a memory in which a correlation between the sensor signal and the usage status of the auto-injector is stored, and a processor that communicates with the active data transmission unit, the memory, and the user interface and / or the communication interface. The processor is programmed to assign the sensor signal to the corresponding usage status of the device for the single administration of a drug.

Description

[0001] The invention relates to a device for the single administration of a drug for medical treatment. The invention relates in particular to a drug delivery device for self-medication.

[0002] Single-dose drug delivery devices include, for example, pre-filled syringes or cartridges. These are often combined with auto-injectors so that patients can self-administer the drug from the pre-filled syringe or cartridge. Auto-injectors are available in electronic versions with a motor or in mechanical versions.

[0003] A key safety requirement for single-use drug delivery devices is the ability to detect whether the device has already been used. This is important for safety reasons, firstly to prevent the device from being reused under the assumption that it still contains a full dose of the drug when only part of the contents has already been used. Furthermore, any remaining contents could be contaminated after use. Secondly, this is necessary because the patient may not remember whether they have used the device completely or partially, and previous use is not readily apparent from the outside.

[0004] Electronic auto-injectors are known to contain systems for tracking their use. These systems collect and store data regarding the time of use, duration of application, amount of medication administered, and potentially other data. The data may also be analyzed and communicated to other devices. Alternatively, additional devices are proposed that connect to the auto-injector to collect the relevant data and potentially assist the user with medication administration, for example, through a reminder function that sends a signal to the user after a certain period of non-use.

[0005] WO2019 / 032784 A1 discloses a medication delivery system for a prefilled syringe with an adapter that is attached to the medication delivery system and reads information from a magnetic sensor. The magnetic sensor is attached to the housing of the medication delivery system or to the adapter. The medication delivery system has a piston that pushes the medication out of the prefilled syringe. A permanent magnet is attached to this piston.

[0006] WO2018 / 195270 A1 discloses a method for tracking a patient's use of an auto-injector and a corresponding external electronic adapter that can accommodate the auto-injector. The electronic adapter has a magnetic field sensor that detects the magnetic field of a magnetic element located on a movable component of the auto-injector.

[0007] All these systems have in common that they are electronic and battery-powered.

[0008] A trend in auto-injectors is toward disposable auto-injectors, which are disposed of after a single use, for hygiene reasons. To conserve resources, disposable auto-injectors should not contain resource-intensive components. Nevertheless, the safety requirement that the system's usage status is recognizable to the user should still be met.

[0009] WO 2021 / 254840 A1 discloses a device for determining the usage status of a device for single-dose drug administration that does not contain its own power supply. The usage status determination works based on magnetic fields. However, with magnetic fields, the decrease in magnetic field strength is continuous, and shadowing is not readily possible. Therefore, it is not always possible to clearly distinguish between multiple states based on the distance between magnets.

[0010] The object of the present invention is to provide an improved system for detecting the usage status for devices for the single administration of drug, wherein the system should be as resource-efficient as possible and therefore, for example, should not have its own power supply such as a battery.

[0011] The solution to the problems according to the invention consists of a device for the single administration of a drug. The device can be a pre-filled syringe or an auto-injector into which a cartridge or a pre-filled syringe, which can also be needle-free, is inserted. The device according to the invention can also be a syringe without a needle or a portable device such as a patch pump. Devices consisting of a syringe and an additional element or adapter are also conceivable. Crucially, there is a first component and a second component, and the second component is movable relative to the first component and is moved for the application. Hereinafter, the first component is referred to as the "housing." The "longitudinal axis" of the housing is defined parallel to the housing wall with its longest dimension.The term “housing” includes, for example, a syringe body, an additional element attached to the syringe body, or a housing of an auto-injector suitable for holding a prefilled syringe or a cartridge (each optionally also needle-free). The term “housing” also includes the housing of other mechanical injection systems. Accordingly, the second, movable component can be a syringe plunger or the plunger of an auto-injector. Other movable elements of an auto-injector, such as a drive spring or a needle shield, can also be considered as movable components, provided that these elements experience a sufficiently large spatial displacement relative to the housing when the drug is administered. The displacement occurs parallel to the longitudinal axis of the housing.

[0012] The device according to the invention for the single administration of a drug comprises a housing and a second component movably arranged within the housing. During the complete administration of the drug, the second component moves from a first position within the housing to a second position. A light source and a sensor are mounted opposite each other within the housing, such that the sensor detects the light from the light source. The light source and sensor are positioned on or within the housing such that, in the first position, the second component does not interfere with the sensor's detection of the light from the light source. In the second position, the second component is located between the light source and the sensor, and the sensor no longer detects the light from the light source.

[0013] In one variant, the light source and sensor are positioned on or inside the housing such that, in the first position, the second component is located between the light source and the sensor, and the sensor does not detect the light from the light source. In the second position, the second component has no influence on the sensor's detection of the light from the light source.

[0014] In another embodiment of the device according to the invention for the single administration of a drug, a light source and a sensor are mounted side by side in or on the housing, so that the sensor does not directly detect the light from the light source. The detection threshold is set such that stray light from the opposite side of the housing does not trigger a signal at the sensor. The beam profile or frequency of the light source is also selected so that no direct light from the light source reaches the detector. The light source and the sensor are positioned on or in the housing such that, in the first position, the second component has no influence on the detection or non-detection of the light from the light source by the sensor. In the second position, the second component is located next to the light source and sensor, and the second component reflects the light from the light source onto the sensor.

[0015] In a variant of this, the light source and sensor are positioned on or in the housing in such a way that the second component in the first position is located next to the light source and sensor and reflects the light from the light source onto the sensor, while the second component in the second position has no influence on the detection of the light from the light source by the sensor.

[0016] In the various versions, the sensor signal—that is, whether the sensor detects light or not—corresponds to the position of the second component. If the second component is in the first position, the single-dose drug delivery device has not yet been used; if the second component is in the second position, the single-dose drug delivery device has already been used. Thus, the sensor signal corresponds to the usage status of the single-dose drug delivery device.

[0017] In all variants, it is also possible to detect intermediate positions of the second component in which the second component only partially shades the light source or only partially reflects the light from the light source. Light is then detected at the detector, but with a reduced light intensity compared to detection without partial shade or without partial reflection. In this case, an additional signal (“attenuated”) from the sensor relating to the light detection can be read out. This is particularly relevant if the intermediate position is close to the second position of the second component and the light sensor in the second position blocks the light from the light source or does not reflect it. When the drug is fully administered, the second component moves from a first position in the housing to the second position in the housing. An intermediate position means that part but not all of the drug has been administered.

[0018] When using multiple sensors and one or more light sources mounted in or on the housing parallel to its longitudinal axis, several intermediate positions of the second component can be detected, each corresponding to an unadministered amount of drug. In these intermediate positions, the light from the light source(s) is either completely or partially blocked or completely or partially reflected for one or more of the sensors. For each individual sensor, the signal indicating light detection (yes / no) or the signal indicating "attenuation" can be read.

[0019] Unless the housing is inherently transparent, it may have a window through which the user can, for example, inspect the position of the second component or the presence of medication in the housing.

[0020] The sensor is connected to an electronic circuit or chip that can communicate with a mobile device via a passive data transmission unit, e.g., via Radio Frequency Data Transmission (RFID). This allows a user to read the sensor's signal (e.g., light detection: yes / no / attenuated). Preferably, an application (app) on a mobile device (e.g., smartphone) is used to transmit the sensor's signal. This application utilizes, for example, high-frequency data transmission capabilities such as UHF, NFC, or RFID, which are available in commercially available mobile devices. To read the signal from the light sensor(s), the app prompts the user (patient, healthcare professional) to touch, nearly touch, or approach the single-dose drug delivery device with the mobile device.The electronics integrated into the single-dose drug delivery device (optical sensor and electronic circuit or chip with passive data transmission unit) are powered by the mobile device, e.g., via radio frequency. This also activates the light source. The mobile device's processor assigns the sensor signal to a usage status (used / unused / incompletely administered) of the single-dose drug delivery device stored in its memory.

[0021] With multiple sensors, further usage statuses can be assigned, depending on which intermediate positions of the second component are detected by corresponding signals at the sensors at the relevant points along the housing. The detected intermediate positions can be assigned to the amount of unapplied drug, e.g., 1 ml not applied, 0.5 ml not applied, etc.

[0022] The optical sensor(s) and / or electronic circuit or chip can be attached to or incorporated into the single-dose drug delivery device as a label (smart label).

[0023] An advantage of the described invention is that the sensor signal can be read and precisely assigned to a usage status without requiring a power supply (e.g., battery) at the single-dose drug delivery device, as the mobile device provides the power when reading the sensor signal for detection (yes / no / attenuated). The usage status (used / unused / incompletely administered, or other) is assigned and communicated by the mobile device. This increases the sustainability of the single-dose drug delivery device and reduces the required user steps, as no separate component or adapter, possibly with an electronic unit, needs to be connected to the device before administration to check the usage status.

[0024] The mobile device has at least the following features: a. An active data transmission unit for communication with the passive data transmission unit of the electronic circuit or chip in the single-dose drug delivery device connected to a processor, b. a memory in which a correlation between the signal of the sensor(s) and the usage status of the auto-injector is stored, c. a processor connected to the active data transmission unit, memory and a user interface and / or a communication interface, wherein the processor is programmed to associate the signal from the sensor(s) with the corresponding usage status of the single-dose drug delivery device.

[0025] The mobile device can be a conventional smartphone, tablet computer, smartwatch, or similar device, provided it has the necessary data transmission unit to communicate with the electronic circuit or chip in the single-dose drug delivery device. This is the case, for example, with conventional smartphones, tablet computers, or smartwatches. Information about the status of the single-dose drug delivery device, such as "used" or "unused," or, if applicable, "incompletely administered," or about the remaining amount of drug, can be provided to the user via the user interface, for example, a display, icon, speaker, or audio output. This information can be transmitted to another digital (end) device.The processor can also be programmed via an application that is loaded onto the separate device.

[0026] The invention further relates to a computer-implemented method, comprehensive the steps - Reading the signal from one or more optical sensors on a device for the single administration of a drug; - Assignment of the sensor signal(s) to the corresponding usage status of the single-dose drug delivery device; - Delivery of information corresponding to the usage status via an interface to the user and / or via a communication interface.

[0027] The invention also relates to a computer program product comprising the commands which, when executed by a mobile terminal equipped with an active data transmission unit, cause it to perform the following process steps. - Reading the signal from the optical sensor(s) on a single-dose drug delivery device; - Assignment of the sensor signal(s) to the corresponding usage status of the single-dose drug delivery device; - Providing information corresponding to the usage status via an interface to the user and / or via a communication interface.

[0028] The computer program product may be an application for a smartphone, tablet computer, smartwatch, or similar device. Figures and examples

[0029] The invention is explained in more detail below in connection with preferred embodiments and with reference to the drawings. Fig. 1 Schematic representation of an auto injector in an unused state Fig. 2 Schematic representation of an auto-injector after incomplete application Fig. 3 Schematic representation of an auto-injector after complete application Fig. 4a Diagram of a moving component in the first position relative to a first arrangement of light source and light sensor Fig. 4b Diagram of a movable component in the 2nd position relative to a first arrangement of light source and light sensor Fig. 5a Diagram of a moving component in 1st position relative to a second arrangement of light source and light sensor Fig. 5b Diagram of a movable component in the 2nd position relative to a second arrangement of light source and light sensor Fig. 6 Schematic representation of an auto-injector in use with a smartphone Reference symbol 100 Auto-Injector 102 cases 104 containers 106 Outlet 108 Piston rod 109 pistons 110 Light source 111 Light 112 Light sensor 114 Sensor electronics 120 distal end 122 proximal end 202 housings 204 moving component 206 Light source 208 Light 210 Light sensor 220 distal end 222 proximal end 300 smartphones

[0030] Some preferred embodiments of the invention are illustrated in the following examples. It should be emphasized, however, that the invention is not limited to these, but may be embodied in other ways within the scope of the claims.

[0031] For the sake of clarity, the figures are schematic and simplified. They show only details essential for understanding the invention, while other details have been omitted. Examples Example 1

[0032] Fig. 1 to Fig. Figure 3 shows an auto-injector 100 with a housing 102. A cartridge with a cannula or a pre-filled syringe with a container 104 for a liquid drug is inserted into the housing 102. To administer the drug from the container 104, a piston rod 108, which is movably mounted in the container 104 parallel to the longitudinal axis of the housing 102, is moved from an initial position ( Fig. 1) in a proximal direction via an intermediate position ( Fig. 2) into a final position ( Fig. 3). The piston rod 108 is in contact with a piston 109 and presses on the piston 109 in the container 104 during application. This forces the drug out of the container 104 of the pre-filled syringe or cartridge in the proximal direction and applies it through the outlet 106.

[0033] If the piston rod 108 with piston 109 is in the intermediate position ( Fig. 2) remain, then the drug from the container 104 would only be applied incompletely.

[0034] A light source 110 and a light sensor 112 are located on the outer wall of the container 104 located in the housing 102 in the region of the proximal end 122 of the container 104. The light source 110 and the light sensor 112 are arranged on opposite sides on the outer wall of the container 104. In Fig. In state 1, where the piston 109 is in its initial state and the pre-filled syringe or cartridge is still unused, the light 111 is not affected and is detected by the light sensor 112. Fig. 2, in which the piston 109 is in an intermediate position and has not yet reached the final position, i.e., the full dose has not been applied, the light 111 is partially blocked by the piston 109 and only the residual light is detected by the light sensor 112. Fig. 3, in which the piston 109 has reached its final position and the full dose has been applied, the light 111 from the light source 110 is completely blocked by the piston 109 and cannot be detected by the light sensor 112. Example 2a

[0035] Fig. 4a and Fig. Figure 4b shows a housing 202 with a light source 206 and a light sensor 210 on the inner wall of the housing 202 in the region of the proximal end 222 of the housing 202. The light source 206 and the light sensor 210 are arranged on opposite sides of the inner wall of the housing 202 near the proximal end 222. Fig. 4a, in which the movable component 204 is located in its initial state at the distal end 220 of the housing 202, the light 208 is not affected and is detected by the light sensor 210. Fig. 4b in which the movable component 204 is in the end position near the proximal end 222 of the housing 202, the light 208 of the light source 206 is blocked or reflected by the movable component 204 and is not detected by the light sensor 210. Example 2b

[0036] Fig. 5a and Fig. Figure 5b shows a housing 202 with a light source 206 and a light sensor 210 on the inner wall of the housing 202 in the region of the proximal end 222 of the housing 202. The light source 206 and the light sensor 210 are arranged next to each other on the inner wall of the housing 202. Fig. In 5a, where the movable component 204 is located in its initial state at the distal end 220 of the housing 202, the light 208 is not detected by the light sensor 210. Fig. 5b in which the movable component 204 is in the end position near the proximal end 222 of the housing 202, the light 208 from the light source 206 is reflected through the movable component 204 and detected by the light sensor 210, which is located next to the light source 206.

[0037] In Fig. Figure 6 shows schematically how the sensor signal is read by a smartphone.

[0038] The smartphone contains a receiver for wirelessly receiving electronic data, e.g., via UHF, NFC, or RFID. An application loaded onto the smartphone 300 controls the measurement of the signal from sensor 112 and its subsequent processing. The measurement is taken at or near a marking on the housing 102 of the auto-injector 100. The display of the smartphone 300 is placed on or near the housing 102 of the auto-injector 100, and the sensor signal is detected. The marking indicates to the user precisely where on or near the housing 102 the smartphone 300 with its display should be positioned. The marking on the housing 102 could be, for example, a mark on the outside of the housing 102 or an adhesive label.

[0039] The application programs the processor of the Smart Phone 300 to assign the signal from the sensor(s) to a usage status of the auto-injector. This usage status is then displayed to the user on the screen or via other means (e.g., haptic feedback). QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2019 / 032784 A1

[0005] WO 2018 / 195270 A1

[0006] WO 2021 / 254840 A1

[0009]

Claims

[1] Device for single administration of medicinal substance containing, a housing; a component movably arranged in the housing, wherein the movably arranged component moves from a first position relative to the housing to a second position relative to the housing upon complete administration of the drug; a light source and a light sensor positioned opposite each other in or on the housing such that in the first position of the movable component, the light from the light source is detected by the light sensor and in the second position, the movable component is located between the light source and the light sensor and blocks the detection of the light at the light sensor, or which are positioned opposite one another in or on the housing in such a way that in the second position of the movable component the light from the light source is detected by the light sensor and in the first position the movable component is located between the light source and the light sensor and blocks the detection of the light at the light sensor; an electronic circuit or chip connected to the light sensor and having a passive data transmission unit through which the sensor's signal regarding light detection (yes / no) can be read. [2] Device for single administration of medicinal substance containing, a housing; a component movably arranged in the housing, wherein the movably arranged component moves from a first position relative to the housing to a second position relative to the housing upon complete administration of the drug; a light source and a light sensor positioned next to each other in or on the housing in such a way that in the first position of the movable component, the light from the light source is not detected by the light sensor and in the second position, the movable component is located in front of the light source and the light sensor and enables the detection of the light by the light sensor by reflecting the light from the light source on the movable component, or which are positioned next to one another in or on the housing in such a way that in the second position of the movable component the light from the light source is not detected by the light sensor and in the first position the movable component is located in front of the light source and the light sensor and enables the detection of the light by the light sensor by reflecting the light from the light source on the movable component; an electronic circuit or chip connected to the light sensor and having a passive data transmission unit through which the sensor's signal regarding light detection (yes / no) can be read. [3] Device according to claim 1 or 2, characterized by that the component which is arranged to be movable in the housing assumes an intermediate position between the first position and the second position in the case of incomplete administration of the medicinal substance, and in the intermediate position partially shades or partially reflects the light of the light source, and that a further signal from the sensor relating to the partial light detection (“attenuated”) can be read out. [4] Device according to one of claims 1 to 3, characterized bythat several sensors and one or more light sources are mounted opposite one another in or on the housing parallel to the longitudinal axis of the housing, and the component which is movably arranged in the housing assumes an intermediate position between the first position relative to the housing and the second position relative to the housing in the event of incomplete administration of the medicinal substance and in the intermediate position completely or partially shades or completely or partially reflects the light of the light source or of the several light sources for one or more of the sensors, and that for each individual sensor the signal for light detection (yes / no) and preferably also the signal for “attenuated” can be read out. [5] Device according to one of claims 1 to 4, characterized by that the case is transparent. [6] Device according to one of claims 1 to 4, characterized by that the housing has a window. [7] Device according to one of claims 1 to 6, characterized by that the housing is a syringe body and the moving component is a syringe plunger or a stopper. [8] Device according to one of claims 1 to 6, characterized by that the housing is an additional element attached to the syringe body and the movable component is a syringe plunger or a plug and the additional element is preferably a finger flange. [9] Device according to one of claims 1 to 6, characterized by that the housing is an auto-injector housing suitable for receiving a pre-filled syringe or cartridge and the moving component is a piston rod, a drive spring or a needle shield. [10] Device according to one of claims 1 to 9, characterized by that the electronic circuit or chip and preferably also the light sensor are integrated into a label applied in or on the housing. [11] Device according to one of claims 1 to 10, characterized by that the location of the electronic circuit or chip is marked on the outside of the housing. [12] Mobile device comprising an active data transmission unit for communicating with the passive data transmission unit of the electronic circuit or chip in the single-dose drug delivery device according to any one of claims 1 to 11; an interface to the user and / or a communication interface; a memory in which a correlation between the signal of the sensor(s) and the usage status of the auto-injector is stored; a processor connected to the active data transmission unit, the memory and the user interface and / or the communication interface, the processor being programmed to associate the signal from the sensor(s) with the corresponding usage status of the single-dose drug delivery device. [13] Mobile terminal according to claim 12, characterized by that the processor is programmed to output the determined usage status of the device for the single administration of medicines via the interface to the user as information indicating the status "used" or "unused" or, where appropriate, "incompletely applied". [14] Mobile terminal according to claim 13, characterized by that the information reflects an unadministered amount of drug. [15] Mobile terminal according to one of claims 12 to 14, characterized bythat the interface to the user is a display, an icon, a speaker, an audio output. [16] Mobile terminal according to one of claims 12 to 15, characterized by that the information is reproduced via an optical or haptic (vibration) signal. [17] Device according to one of claims 12 to 16, characterized by that the mobile device is a smartphone, a smart watch or a tablet computer.

Images