Capture system for electronic control of a drug delivery system

Abstract

The present disclosure relates to an electronically controlled capturing system (100) for capturing data (126) representing an amount of drug expelled or discharged from a drug reservoir (6) by a drug delivery system (1), the capturing system (100) comprising an electronic circuit (108) comprising an electrical energy unit (116) comprising an electrical energy store (117), a processing unit (114) operable by electrical power obtained from the electrical energy unit (116), the processing unit (114) being operable for acquiring data (126), an electronic storage unit (118) connected to the processing unit (114), the electronic storage unit (118) being configured to store the acquired data (126), wherein the processing unit (114) is operable for writing the acquired data (126) into the electronic storage unit (118), and wherein the processing unit (114) is operable for reading the stored data (126) from the electronic storage unit (118) and for providing the stored data (126) from the electronic storage unit (118), a data read-out disabling unit (160) operably connected to at least one of the processing unit (114), the electronic storage unit (118) and the electrical energy unit (116), the data read-out disabling unit (160) being switchable into an active state in which the data read-out disabling unit (160) permanently prevents at least one of the reading out of stored data (126) from the electronic storage unit (118) or the providing of stored data (126) from the electronic storage unit (118).

Description

Technical Field

[0001] This disclosure relates to the field of drug delivery systems, and more particularly to drug delivery systems for parenteral administration of drugs or pharmaceutical preparations. This disclosure also relates to an electronically controlled capture system for capturing data representing the amount of drug expelled or discharged from a drug reservoir via the drug delivery system. This disclosure further relates to an electronically controlled capture system provided as a stand-alone device or as a discrete device configured to be connected to or attached to a drug delivery system. This disclosure further relates to an electronically controlled capture system integrated into a drug delivery system, such as an injection device, infusion device, like a pen syringe, or an infusion pump. Background Technology

[0002] Drug delivery systems and devices for setting and dispensing single or multiple doses of liquid medications are well known in the art. Typically, such devices can serve purposes substantially similar to those of ordinary syringes.

[0003] Drug delivery devices (such as pen injectors) must meet many user-specific requirements. For example, patients with chronic conditions such as diabetes may be frail and visually impaired. Therefore, suitable drug delivery devices, especially those designed for home use, need to be robust in construction and easy to use. Furthermore, the manipulation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide the setting and subsequent dispensing of variable-sized drug doses. In addition, the dosage setting and dispensing procedures must be easy to operate and clearly defined.

[0004] Typically, such devices include a housing or specific cartridge adapted to receive a drug reservoir, such as a cartridge at least partially filled with a drug to be dispensed or expelled. The device further includes a drive mechanism, typically having a displaceable piston rod operably engaged with a stopper or piston of the cartridge. By means of the drive mechanism and its piston rod, the stopper or piston of the cartridge can be displaced distally or in the dispensing direction, and thus a predefined amount of drug can be expelled via a puncture assembly (e.g., in the form of an injection needle), which is releasably coupled to a distal segment of the housing of the drug delivery device. Other drug delivery systems may include a pump that provides a fairly continuous parenteral administration of liquid drugs, for example, by infusion.

[0005] For some drug delivery devices (such as pen-type injection devices), the user may have to set a variable dose by rotating the dose selector dial and dose selector sleeve clockwise or in the dose-increasing direction relative to the body or housing of the injection device. To inject and dispense a dose of liquid medication, the user may have to press a trigger or dose button distally and therefore toward the body or housing of the injection device. Typically, the user applies distal pressure to the dose button (located proximal to the dose selector dial and dose selector sleeve) with their thumb while gripping the housing of the injection device with the remaining fingers of the same hand.

[0006] Some drug delivery devices (such as pen syringes) are configured as single-use devices. They are pre-filled with injectable medication. When the medication is used up, the entire drug delivery device is discarded. There are also reusable drug delivery devices, such as pen syringes, equipped with a medication reservoir intended to be replaced when the medication contained therein is depleted. Such reusable drug delivery or injection devices make it possible to replace the medication reservoir or medication container, such as a cartridge.

[0007] For injection devices, it is desirable to be able to accurately, reliably, and semi-automatically monitor and / or collect administration-related data, such as injection-related data during the use of the drug delivery device or injection device. Some drug delivery devices may be equipped with electronically implemented add-ons or data capture devices configured to monitor actions caused by the user of the injection device. Some other drug delivery devices may include integrated data capture units or data capture devices configured to capture and / or collect data regarding the administration of medication to the patient. Data capture units or devices are particularly useful for debilitated patients or those who have difficulty accurately remembering the dosage to be administered or the timing of medication administration.

[0008] Data capture systems and devices used in conjunction with drug delivery systems or devices can collect highly personal data, such as indicating the dosage of a specific medication administered to a particular patient. This highly sensitive data may remain in the electronic storage of such capture systems even after the associated injection device or system is no longer in use. Drug delivery systems or devices that include integrated data capture systems or devices may reach the end of their lifecycle and should not be used subsequently. This is particularly true for single-use drug delivery devices or injection devices intended to be discarded entirely after use. When the lifecycle of a data capture system or at least one of the associated drug delivery systems or devices has ended, the data captured and stored in the capture system should be protected from unauthorized use.

[0009] Therefore, it is desirable to provide a capture system for capturing data about the amount of drug expelled or discharged by a drug delivery system, the capture system providing prevention of unauthorized use of the captured data when the capture system and / or the associated drug delivery system or drug delivery device has reached the end of its life cycle. In this regard, the purpose of the capture system is to prevent unauthorized use of personal data captured during the use of the drug delivery system or drug delivery device. Summary of the Invention

[0010] In one instance, this disclosure relates to an electronically controlled capture system for capturing data representing the amount of drug discharged or released from a drug reservoir via a drug delivery system or drug delivery device. The capture system includes electronic circuitry. The electronic circuitry includes a power unit that includes a power storage device. The electronic circuitry further includes a processing unit that is operable by power obtained from the power unit. The processing unit is operable to acquire data. The electronic circuitry further includes an electronic storage unit connected to the processing unit. The electronic storage unit is configured to store the acquired data. Specifically, the electronic storage unit is configured to store data previously acquired by the processing unit. The processing unit is also operable to write the acquired data into the electronic storage unit. The processing unit is also operable to read the stored data from the electronic storage unit. The processing unit is also operable to provide the stored data from the electronic storage unit.

[0011] The electronic circuitry further includes a data read-disable unit operatively connected to at least one of the processing unit, the electronic storage unit, and the power unit. The data read-disable unit can be switched to an active state. In the active state, the data read-disable unit permanently prevents at least one of the following: reading the stored data from the electronic storage unit or providing the stored data from the electronic storage unit.

[0012] The electronic circuitry's data readout disable unit provides inhibition of data access to data previously acquired by the processing unit and / or stored in the electronic storage unit during the lifecycle of the electronically controlled capture system and / or during the lifecycle of the drug delivery system associated with the electronically controlled capture system.

[0013] In the active state, the data read disable unit can be configured to disable the operation of the processing unit. Here, the data read disable unit can be configured to shut down the processing unit or disconnect the processing unit from any other data processing device (such as a transmission interface). Therefore, the data read disable unit can be configured to disable data communication from at least the processing unit. Furthermore, the data read disable unit can be operatively connected to the processing unit in a manner that allows the data read disable unit to disconnect the processing unit from at least one of the power unit and the electronic storage unit.

[0014] Therefore, the data read disable unit can be configured to disconnect the processing unit from at least one of the power unit or the electronic storage unit. In this way, data stored in the electronic storage unit can no longer be retrieved from the electronic storage unit. The processing unit may not have its own electronic storage device. Furthermore, the electronic storage unit can only be accessed through the processing unit. The electronic storage unit and the processing unit are components of an electronic circuit. Data stored within the processing unit can only be acquired and read through the processing unit.

[0015] In other instances, and when the data read disable unit is operatively connected to the electronic storage unit, the data read disable unit can also be configured to disconnect the data connection between the electronic storage unit and the processing unit.

[0016] Alternatively, the data read disable unit can be operated to corrupt and / or destroy data stored in the electronic storage unit. In some instances, the data read disable unit can be configured to modify the data stored in the electronic storage unit to effectively render the data unusable. Furthermore, the data read disable unit can be operated to delete data stored in the electronic storage unit. The data read disable unit can also be operated to reorganize or disrupt the storage management of the electronic storage unit. In this way, data can remain in the electronic storage unit but cannot be read in a controlled manner.

[0017] In another instance, and when the data read disable unit is operatively connected to the power unit, when switched to the active state, the data read disable unit can be configured to disconnect the power unit from at least one of the processing unit and the electronic storage unit. By disconnecting the power unit from the processing unit, the processing unit becomes substantially inoperable. As long as the data read disable unit is active, the power unit is disconnected from at least one of the processing unit and the electronic storage unit and remains disconnected. In this way, the data read disable unit is configured to cut off power to the processing unit and / or the electronic storage unit. When the processing unit is disconnected from the power unit by activating the data read disable unit, the reading and provisioning of data stored in the electronic storage unit is effectively prohibited. In another case, and when the electronic storage unit is disconnected or disconnected from the power unit due to the activation of the data read disable unit, the processing unit becomes unable to access the stored data allocated in the electronic storage unit.

[0018] In other instances, the data read disable unit is operatively connected to the power unit such that the data read disable unit is operable to deplete or release the power unit's electrical energy when switched to an active state.

[0019] As long as the data read disable unit is in and remains in an active state, the data read disable unit will permanently prevent the stored data from being read from the electronic storage unit or the stored data from being provided from the electronic storage unit.

[0020] Specifically, and when switched to the active state, the data read disable unit is operable to disconnect or disrupt communication or connection between the power unit and the processing unit, between the processing unit and the electronic storage unit, and / or between the power unit and the electronic storage unit. In another instance, and when switched to the active state, the data read disable unit is configured to modify the configuration, structure, or operation of at least one of the power unit, the processing unit, and the electronic storage unit.

[0021] In any way, and in all instances of electronically controlled capture systems, once the data read disabling unit is activated, the data stored in the electronic storage unit becomes permanently inaccessible. Even if the data read disabling unit can be switched to a deactivated state, the data remains inaccessible.

[0022] In another instance, the data readout disable unit is irreversibly switched to an active state. Typically, and throughout the entire lifecycle of the electronically controlled capture system and / or associated drug delivery system or device, the data readout disable unit is in a deactivated state. Through user action or when the end of the lifecycle of the electronically controlled capture system or drug delivery system has been reached, the data readout disable unit is manually or autonomously switched from a deactivated state to an active state, thereby permanently preventing at least one of the following: reading the stored data from the electronic storage unit or providing the stored data from the electronic storage unit. Once the data readout disable unit is switched to an active state, it cannot be switched back to a deactivated state.

[0023] In some instances, switching a data read disabling unit from a disabled state to an active state results in the irreversible shutdown of the processing unit or the irreversible disconnection of the processing unit from at least one of the power unit and the electronic storage unit. This shutdown or disconnection is irreversible. In other words, once the processing unit is shut down, it cannot be restarted. Furthermore, once the processing unit has been disconnected from the electronic storage unit or from another data processing device, it cannot be reconnected to the electronic storage unit or the other data processing device, for example, implemented as a transmission interface.

[0024] Furthermore, when the activation of the data read disable unit involves disconnecting the processing unit from the power unit, this disconnection is irreversible. Once the processing unit has been disconnected from the power unit and / or from the electronic storage unit, this connection cannot be re-established even if it is possible for the data read disable unit to switch from the active state back to the deactivated state.

[0025] Therefore, the first or subsequent activation of the data read disable unit typically has an irreversible effect on the connection between one or more of the power unit, processing unit, and electronic storage unit, and / or between any two of the power unit, processing unit, and electronic storage unit. By switching the data read disable unit to the active state, at least one of the processing unit, electronic storage unit, and processing unit can become irreversibly modified or reconfigured, such that reading the stored data and / or providing the data to another data processing device (e.g., a transmission interface) will be permanently blocked and therefore no longer possible.

[0026] According to another example, the energy storage device is a finite storage device for electrical energy. Alternatively or additionally, the energy storage device is non-rechargeable. Specifically, the energy storage device may include a non-replaceable and / or non-rechargeable battery. In this way, and once the power of the energy unit has been consumed, any further operation of the electronically controlled capture system is disabled due to power loss. When switched to the active state, the data read disable unit is operable to invoke the premature depletion or disconnection of the finite energy storage device. Therefore, in the case of a finite energy storage device, and particularly in the case of a non-replaceable and non-rechargeable battery, the data read disable unit can be configured to deplete the electrical energy from the energy storage device, thereby prohibiting further electrical operation of the electronically controlled capture system.

[0027] According to another embodiment, the data read disable unit is operable to disconnect the processing unit from at least one of the electronic storage unit and the power unit when it is in an active state. Specifically, the data read disable unit is operable to irreversibly disconnect the processing unit from at least one of the electronic storage unit and the power unit when switching to an active state. Here, there is a particular advantage to the data read disable unit irreversibly switching to an active state. Therefore, once the data read disable unit has switched to an active state, the processing unit is disconnected from at least one of the electronic storage unit and the power unit. Permanently and / or irreversibly disconnecting the processing unit from the electronic storage unit prevents the reading of stored data from the electronic storage unit. Disconnecting the processing unit from the power unit results in complete failure of the electronic circuitry. In this way, the data stored in the electronic storage unit is and remains inaccessible.

[0028] According to another example, the data read disable unit is operable to disconnect the power unit from the processing unit when in an active state. Alternatively or additionally, when in an active state, the data read disable unit is operable to disconnect the power unit from the electronic storage unit. In some specific examples, the data read disable unit is operable to irreversibly disconnect the power unit from at least one of the processing unit and the electronic storage unit when in an active state. By disconnecting the power unit from the processing unit, the processing unit no longer has sufficient power to drive itself. In some examples, and when the electronic storage unit includes volatile memory, by disconnecting the power unit from the electronic storage unit, the data stored in the volatile memory can be automatically deleted or corrupted to effectively prevent the stored data from being read.

[0029] According to another example, the data read disable unit is operable to discharge the power unit when it is in an active state. By activating the data read disable unit, the power unit can be discharged. The electrical energy supplied in the power unit can be depleted by switching the data read disable unit to an active state. For this purpose, the data read disable unit may include a mechanical switch or a micromechanical switch that, when activated, causes the power unit to be depleted. The switch or micromechanical switch is operable to provide a short circuit or bypass to deplete the remaining electrical energy from the power unit when the data read disable unit is activated.

[0030] In this example, and when the data read disable unit is operable to discharge from or deplete the power unit, the power unit is typically implemented as a limited storage device for electrical energy. Here, the power unit may consist of a non-rechargeable and non-replaceable battery. If the power unit's energy has been depleted or consumed to a predefined level, further operation of the electronically controlled capture system will be disabled.

[0031] According to another example, the data read disable unit is operable to delete stored data from the electronic storage unit when it is in an active state. Furthermore, by switching the data read disable unit to an active state, data stored in the electronic storage unit can be deleted, particularly irreversibly. Here, the data read disable unit can be configured to overwrite or overwrite many volatile or non-volatile memory blocks of the electronic storage unit. By overwriting the data stored in the volatile or non-volatile memory of the electronic storage unit, the data previously stored in the electronic storage unit is irrecoverably lost. Highly sensitive personal data captured and stored in the electronic storage unit will never be able to be read again.

[0032] In another example, the data read disable unit is operable to encrypt acquired data or data stored in an electronic storage unit when it is in an active state. Typically, the data read disable unit is operable to irreversibly encrypt acquired or stored data when switched to an active state and / or afterwards.

[0033] Furthermore, when switching the data read disabling unit, the data obtained from the processing unit and / or the data previously stored in the electronic storage unit is irreversibly encrypted. To this end, an encryption routine is performed using an encryption key with a predetermined bit size. The length of the encryption key is selected based on the available computing power. Typically, the encryption key is selected such that even using a supercomputer with the maximum available computing power would require several years to crack the encryption code or key.

[0034] In this example, the data acquired by the processing unit is stored and remains stored in an electronic storage unit. However, the data is irreversibly encrypted and cannot be decoded using currently available computing power. Therefore, the encrypted acquired or stored data cannot be read from and / or provided to the electronic storage device.

[0035] According to another example, the data read disabling unit is operable to prevent the decryption of stored data, which is stored in the electronic storage unit in an encrypted format, when it is in the active state. Here, using this example, the processing unit is operable to decrypt acquired data and store it in the processing unit in an encrypted format. The processing unit is operable to decrypt the data stored in the electronic storage unit in an encrypted format as long as the data read disabling unit is inactive and therefore disabled. However, when the data read disabling unit is activated, the decryption capability of the processing unit is disabled. The decryption capability of the processing unit is typically irreversibly disabled.

[0036] Disabling the decryption capability of the processing unit can be provided in many different ways. Specific functions of the processing unit can be permanently disabled when the data read disabling unit is switched to an active state. Here, the data read disabling unit can be operated to manipulate or reconfigure the processing unit such that, in response to the activation of the data read disabling unit, the processing unit's decryption capability is permanently disabled. Here, the disabling of the processing unit's decryption capability can be implemented in software. For example, the decryption or encryption key stored locally in the processing unit can be modified or corrupted, causing the decryption or encryption key to become irrecoverably lost.

[0037] In another instance, disabling the decryption capability of the processing unit can be achieved by storing the corresponding encryption or decryption key in a volatile memory block of the electronic storage unit. By activating the data read disabling unit, the power supply to the electronic storage unit can be cut off. In this way, the encryption or decryption key stored in the volatile memory is irrecoverably lost. Without the corresponding encryption or decryption key, data stored in the electronic storage unit in encrypted format cannot be decrypted. In effect, encrypted data is irrecoverably lost without access to the encryption or decryption key. In another instance, the encryption or decryption key is simply deleted when the data read disabling unit is activated.

[0038] According to another example, the electronically controlled capture system further includes a data transmission interface connected to the processing unit and connectable to an external electronic device via data transmission. Here, a data read disable unit is operable to interrupt or disable the data transmission connection between the processing unit and the data transmission interface. In some instances, the data read disable unit is operable to irreversibly interrupt or disable the data transmission connection between the processing unit and the data transmission interface. In this manner, the processing unit may be further operable to read data from the electronic storage unit, but the data read from the electronic storage unit will no longer be available to the data transmission interface. Alternatively, the data read disable unit may be configured or operable to modify or reconfigure the data transmission interface such that it is no longer possible to submit data from the electronically controlled capture system to an external electronic device.

[0039] Therefore, the data read disable unit is configured to interrupt or disrupt the data transmission connection between the processing unit and the data transmission interface. The data read disable unit can be configured to irreversibly interrupt or disrupt the data transmission connection between the processing unit and the data transmission interface. Alternatively, the data read disable unit can be configured to disable the operation of the data transmission interface or the data transmission capability of the processing unit. Additionally, or as another alternative, the data read disable unit can operate a data transmission protocol for irreversibly modifying or reconfiguring at least one of the data transmission interface and the processing unit. In this way, data transmission communication between the processing unit and the data transmission interface can be permanently and / or irreversibly disabled.

[0040] In many instances, the data read-disable unit is implemented entirely electronically. In some instances, the data read-disable unit is implemented entirely in software. The data read-disable unit may be implemented as a logical unit of at least one of the power unit, the processing unit, or the electronic storage unit. In other instances, the data read-disable unit is implemented in hardware. It can be implemented by hardware electrically connected to at least one of the power unit, the processing unit, and the electronic storage unit. Furthermore, the data read-disable unit may be provided and implemented as a discrete mechanical or electromechanical component operatively connected to at least one of the processing unit, the electronic storage unit, and the power unit. The data read-disable unit can be manually activated by a user simply by pressing a button or some other type of mechanical actuation mechanism. By manually activating the data read-disable unit, hardware modifications to the electronically controlled capture system can be easily made, where such modifications are typically irreversible. Once the hardware is modified by activating the data read-disable unit, the operation of at least one of the power unit, the processing unit, and the electronic storage unit is modified so that it is no longer possible to read the stored data.

[0041] Alternatively, or in an alternative, the interaction between at least two of the power unit, processing unit, and electronic storage unit is modified or reconfigured to permanently disable the reading of stored data from the electronic storage device.

[0042] In some instances of the capture system, and when the capture system includes a data transmission interface connected to the processing unit, the activation of the data read disabling unit, and thus the switching of the data read disabling unit to an active state, is blocked as long as the data stored in the electronic storage unit has not yet been transferred to an external electronic device via the data transmission interface. In other words, activation of the data read disabling unit requires the transfer of stored data from the electronic storage device to the external electronic device via the data transmission interface. In this way, it is ensured that the acquired data stored in the storage unit has been further processed and backed up. Specifically, the stored data can be further processed for data analysis, such as for checking adherence to prescription medication schedules.

[0043] In some instances, preventing the reading or provision of stored data from the electronic storage unit applies only to a portion of the data stored in the storage unit. At least one of the data read disabling unit, the electronic storage unit, and the processing unit can be configured to disable the reading or provision of stored data only for data preceding a predefined time interval in actual time. Here, the data read disabling unit can be configured to limit the expiration period. In this way, the data read disabling unit is operable to prevent at least one of the following from being read from or provided from the electronic storage unit only for the portion of stored data earlier than the expiration date.

[0044] The expiration date can be a moving date or a moving time, and can be defined by a time interval compared to the actual time. This ensures and specifies that recently acquired and stored data in the electronic storage unit cannot be prematurely deleted or erased. In this way, information regarding the recent discharge or release of a certain amount of medication from the drug reservoir by the drug delivery system can be specified as readable by the processing unit. Therefore, in an emergency, medical personnel and others can at least read the most recently stored data from the electronic storage unit. This may help identify or classify temporary emergency situations in patients.

[0045] According to another example, the electronic circuitry further includes a lifecycle end-of-life identification unit. This lifecycle end-of-life identification unit is operable to determine and / or indicate the lifecycle end of at least one of the capture system and the drug delivery system. The lifecycle end-of-life identification unit can be implemented in a variety of different ways. Using the lifecycle end-of-life identification unit, a point in time after which the electronically controlled capture system or drug delivery system should no longer be used and should be discarded can be identified automatically or autonomously. The lifecycle end-of-life identification unit enables the automatic determination of the lifecycle end of the capture system and / or the associated drug delivery system or drug delivery device. Once the lifecycle end condition has been identified or indicated, a data readout disable unit can be switched to an active state. The lifecycle end-of-life configuration can be identified through the lifecycle end-of-life identification unit. This can help or can be used as a trigger to activate the data readout disable unit and permanently disable or prevent the reading or provision of stored data from the electronic storage unit.

[0046] The lifecycle end identification unit is operatively connected to at least one of a data readout disable unit, a processing unit, an electronic storage unit, and a power unit. In some instances, the lifecycle end identification unit is limited to indicating the lifecycle end configuration of the drug delivery device. The user may then become aware of the lifecycle end configuration and may decide to manually activate the data readout disable unit before discarding the electronically controlled capture system. In other instances, the lifecycle end identification unit is operatively connected to the data readout disable unit such that the lifecycle end identification unit is operable and / or configured to switch the data readout disable unit to an active state upon detecting or determining the lifecycle end configuration. However, again here, switching the data readout disable unit to an active state may require further user interaction. For example, the lifecycle end identification unit may be configured to communicate with the user of the electronically controlled capture system and may require the user to acknowledge that the data readout disable unit is automatically activated or triggered by the lifecycle end identification unit.

[0047] According to another example, the lifecycle end identification unit is operatively connected to the data read disable unit. The lifecycle end identification unit is operable to set the data read disable unit to an active state. The lifecycle end identification unit is also operable to switch the data read disable unit to an active state. The lifecycle end identification unit may be specifically implemented to automatically switch the data read disable unit to an active state, thereby permanently preventing at least one of the following: reading the stored data from the electronic storage unit or providing the stored data from the electronic storage unit.

[0048] According to another example, the lifecycle end-of-life identification unit is operable to determine the amount of available electrical energy of an energy unit. The lifecycle end-of-life identification unit is also operable to compare the determined or available electrical energy with a predefined minimum electrical energy of the energy unit. In other words, the lifecycle end-of-life identification unit is operable to autonomously detect or determine the amount of available or remaining power or energy of the energy unit. By comparing the available or remaining amount of electrical energy with a predefined minimum, the lifecycle end-of-life identification unit is operable to indicate to at least one of the processing unit, electronic storage unit, or data read-disable unit that the capture system and / or the energy unit is approaching a state of insufficient power or energy shortage.

[0049] For example, a predefined minimum amount of electrical energy can reflect the minimum amount of electrical energy required to initiate or execute a write or erase procedure on the electronic storage unit. Here, the lifecycle end-of-life identification unit can operate to trigger at least one of the processing unit and the data read disable unit to initiate and / or execute the deletion or erasure operation of data stored in the electronic storage device. By determining the available or remaining electrical energy of the power unit, uncontrolled power loss can be avoided. In this way, and before the system detects a lack of power or energy, the data read disable unit can autonomously switch to an active state to prevent the reading of stored data from the electronic storage unit or the provision of stored data.

[0050] If a comparison of available electrical energy with a predefined minimum electrical energy indicates that the available or remaining power is greater than the predefined minimum electrical energy, then the capture system can operate in a conventional manner to acquire data and store the data in an electronic storage unit.

[0051] However, and when a comparison of the available or remaining amount of electrical energy with a predefined minimum amount of electrical energy indicates that the capture system is running out of power or energy, at least one of the processing unit and the data read disable unit can autonomously trigger a lifecycle end routine. The lifecycle end routine can be configured in many different ways. In one instance, the lifecycle end routine is programmable in the processing unit or in the data read disable unit. The lifecycle end routine can define a number of steps that must be performed or executed when the capture system reaches its lifecycle end configuration.

[0052] In some instances, the lifecycle end routine may include initiating a backup of the stored data from the electronic storage unit. Here, the processing unit may autonomously trigger the transfer of acquired and / or stored data from the electronic storage unit to an external electronic device. For this purpose, the electronic storage unit may operate to establish a communication link to a transmission interface or establish a communication link between the transmission interface of the capture system and a matched transmission interface of the external electronic device. When the data backup process is complete, the lifecycle end routine may include further steps to erase the data stored in the electronic storage unit.

[0053] In other instances, the lifecycle end routine may include the step of irreversibly disconnecting the processing unit from at least one of the power unit and the electronic storage unit. In other instances, the lifecycle end routine includes the step of disconnecting the power unit from at least one of the processing unit and the electronic storage unit. In other instances, the lifecycle end routine includes the step of irreversibly depleting the power or energy from the power unit. In yet another instance, the lifecycle end routine may be operable to trigger irreversible encryption of acquired data or stored data in the electronic storage unit. By yet another instance, the lifecycle end routine includes the step of irreversibly preventing the decryption of data stored in the electronic storage unit in an encrypted format. In practice, the lifecycle end routine may include or provide any of the foregoing means to prevent at least one of the following: reading the stored data from the electronic storage unit or providing the stored data from the electronic storage unit.

[0054] According to another example, the lifecycle end identification unit includes a counter operable to determine at least one of the following: the number of times the drug delivery system has been used, the time since one of the drug delivery system and the capture system was first used, and the number of replaceable drug containers used with the drug delivery system. The counter and / or the lifecycle end identification unit may be integrated into the processing unit of the capture system. The number of times the drug delivery system has been used, the time since one of the drug delivery system and the capture system was first used, and / or the number of replaceable drug containers used with the drug delivery system may be derived from data obtained by the processing unit during the expected use of the combination of the capture system and the drug delivery system.

[0055] Furthermore, the counter can be activated by the user of the capture system and / or the user of the drug delivery system. Here, the counter and / or the lifecycle end identification unit can be set with a predefined maximum number of uses of the drug delivery system, a maximum time since the first use of either the drug delivery system or the capture system, and a maximum number of replaceable drug containers used with the drug delivery system. If the determined quantity or the determined time is close to, equal to, or exceeds the predefined maximum quantity or the predefined maximum time, then the lifecycle end identification unit can operate to indicate that the lifecycle end configuration of the capture system and / or the drug delivery system and / or the drug containers used with the drug delivery system has been reached. The lifecycle end identification unit can indicate this lifecycle end condition to the user of the capture system and / or the user of the drug delivery system. The lifecycle end configuration identified in this particular manner by the lifecycle end identification unit can further autonomously trigger at least one of the processing unit and the data read disable unit to switch the data read disable unit to an active state, thereby permanently preventing at least one of the following: reading stored data and / or providing stored data from the electronic storage unit.

[0056] Once the counter determines that the number of times the drug delivery system has been used is close to, equal to, or exceeds the predefined maximum number of uses for the drug delivery system, the lifecycle end identification unit and / or processing unit can be operated to trigger or perform the aforementioned lifecycle end routine. This also applies when the counter determines that the time since the first use of one of the drug delivery system and the capture system is close to, equal to, or exceeds the predefined maximum time since the first use of one of the drug delivery system and the capture system.

[0057] Accordingly, at least one of the lifecycle end identification unit, processing unit, and data reading disable unit may be configured to initiate or trigger the lifecycle end routine when a determined number of replaceable drug containers used with the drug delivery system approaches, equals, or exceeds a predetermined maximum number of replaceable drug containers used with the drug delivery system.

[0058] According to another example, the life-cycle end identification unit is operatively connected to at least one sensor. The at least one sensor is operable to determine at least one of the following: temperature, pressure, humidity, motion, orientation, presence and / or intensity of electromagnetic radiation, and integrity of the drug delivery system. In this manner, the sensor may include, or may be implemented as, a temperature sensor, pressure sensor, humidity sensor, motion or acceleration sensor, orientation sensor, light detection sensor, or integrity sensor of the drug delivery system. The life-cycle end identification unit is also operable to process signals provided from the at least one sensor. The sensor provides sensor signals processed by the life-cycle end identification unit to generate sensor data. At least one of the data readout disable unit, processing unit, and life-cycle end identification unit is operable to compare the sensor data provided and / or processed by the life-cycle end identification unit with predefined sensor data (e.g., defining the environment or environmental conditions under which the drug delivery system should be used).

[0059] For example, in cases where a drug delivery system is used or stored in a non-compliant environment or surrounding environment, such as when the drug delivery system is kept at high temperatures for more than the maximum permissible time interval, the drugs contained in the reservoir may deteriorate and should no longer be used. Such non-compliant environmental conditions can be detected by means of at least one sensor. If the environmental conditions are detected as no longer matching predefined environmental conditions, the lifecycle end identification unit can instruct the user of the capture system or drug delivery system that the drugs provided in the drug reservoir should no longer be used and, for example, the entire drug delivery system should be discarded. This is particularly applicable to instances where the drug delivery system is a disposable drug delivery system and / or where the capture system is integrated into the drug delivery system. In this case, the lifecycle end identification unit is operable to trigger at least one of the processing unit and the data read disabling unit to switch the data read disabling unit to an active state.

[0060] The at least one sensor may be implemented as an environmental sensor. Examples of environmental sensors used with drug delivery systems (such as injection devices) are disclosed, for example, in WO2016 / 115372 A1, the disclosure of which is incorporated herein by reference.

[0061] According to another example, the lifecycle end-of-life identification unit includes a controller operable to detect user-initiated actions of the drug delivery system, wherein such user-initiated actions include dispensing a dose of drug. The controller is also operable to record user-initiated actions over time. The controller is further operable to estimate a drug dosing regimen based on the recorded user-initiated actions, the dosing regimen including at least one of periodicity and time or time window for the user-initiated actions of the drug delivery system. The controller is also operable to determine any discrepancies between the use of the drug delivery system and the estimated dosing regimen. Therefore, the controller may be pre-programmed or may be provided with predefined dosing regimens.

[0062] The controller can also be operated to detect and record user-initiated actions of the drug delivery system over time. In this way, the controller can be operated to estimate whether actual use of the drug delivery system conforms to a predefined medication or prescription schedule. When the controller determines non-compliance with the use of the drug delivery system, this can be an indication that the user has lost access to the drug delivery system and / or the capture system. Detection of non-compliance with the estimated dosing regimen can automatically trigger the lifecycle end-of-life routine as described above and / or trigger the data read-disable unit to switch to an active state. Detection or determination of non-compliance can be an indication that the user no longer uses the drug delivery system and / or the capture system. To prevent misuse of the stored data in the electronic storage unit, determining or detecting non-compliance between the use of the drug delivery system and the estimated dosing regimen can therefore automatically trigger the data read-disable unit to switch to an active state, thereby permanently preventing at least one of the following: reading the stored data from the electronic storage unit or providing the stored data.

[0063] Some examples of how to determine non-compliance with the use of a drug delivery system and the estimated dosing regimens implemented herein are described in document EP2729202 B1, the disclosure of which is incorporated herein by reference.

[0064] According to another example, the controller of the lifecycle end-of-life identification unit is integrated into the processing unit. Here, the processing unit may include the controller of the lifecycle end-of-life identification unit. Furthermore, the entire lifecycle end-of-life identification unit may be integrated into the processing unit of the electronic circuitry of the electronically controlled capture system. The controller of the lifecycle end-of-life identification unit may be a logic unit or logic module of the processing unit. The lifecycle end-of-life identification unit and / or its controller may be integrated into the hardware components of the processing unit. In this way, the production cost and expenditure of the hardware components used to provide the electronic circuitry can be kept at a considerably low level, thereby enabling the implementation of the electronic circuitry in a disposable electronically controlled capture system.

[0065] According to another example, the lifecycle end identification unit includes a data exchange detector. The data exchange detector is operable to detect and / or record data communications established between the capture system and external electronic devices over time. The data exchange detector can be integrated into the controller of the lifecycle end identification unit. Therefore, the data exchange detector can also be integrated into the processing unit of the electronic circuitry. With the help of the data exchange detector, periodic data communications between the capture system and external electronic devices can be monitored and surveyed. The data exchange detector can estimate the data exchange scheme between the capture system and external electronic devices based on detected user-initiated actions. Estimated or predefined data exchange schemes can be provided based on periodicity and / or based on predefined data exchange routines or procedures.

[0066] A data exchange detector can detect whether the data exchange conforms to the estimated data exchange scheme. In this way, and upon detecting a discrepancy between the data communication between the capture system and the external electronic device and the estimated or predefined data exchange scheme, the lifecycle end-of-life identification unit is operable to trigger at least one of the processing unit and the data read disabling unit to switch the data read disabling unit to an active state. The external electronic device can be implemented as a mobile electronic device equipped with a matching transmission interface operable to establish a communication link with the transmission interface of the capture system.

[0067] External electronic devices may include smartphones, smartwatches, blood glucose monitoring devices, and / or wired or wireless data exchange environments. In typical use cases, the data exchange detector and / or end-of-life identification unit may periodically pair with selected or predefined external electronic devices. The data exchange detector and / or end-of-life identification unit may be programmed to periodically request or periodically establish a communication link with at least one of the previously identified or detected external electronic devices. If such external electronic devices are unavailable within predefined time intervals (e.g., over several hours, days, or weeks), this can be an indication that the capture system is no longer being used in the trusted data exchange environment. This situation can be autonomously identified by the data exchange detector as a non-compliance with the data exchange scheme. In response to the detection of non-compliance, the data exchange detector may operate to activate and / or switch the data read disabling unit to an active state, using at least one of the trigger processing unit and the data read disabling unit.

[0068] In another example, the end-of-life identification unit is integrated into the processing unit. Therefore, the end-of-life identification unit and the processing unit are provided by the same hardware component. Typically, the electronic circuitry includes a microprocessor. Both the end-of-life identification unit and the processing unit are integrated within the microprocessor. The processing unit and the end-of-life identification unit are discrete logic blocks within the microprocessor.

[0069] According to another example, the processing unit is provided by a microprocessor. Alternatively, the processing unit is implemented within a microprocessor. The microprocessor may include at least one or more microcontrollers. The microprocessor may include a field-programmable gate array (FPGA).

[0070] According to another example, the microprocessor is configured to set the data read-disable unit to an active state. Here, the switching of the data read-disable unit to the active state can be performed and triggered by the microprocessor. In this way, the data read-disable unit can be switched to the active state through electronic signal processing provided by the microprocessor. Switching the data read-disable unit to the active state can be implemented exclusively by software. The activation of the data read-disable unit can be caused by a software command initiated by the user or autonomously initiated by the processing unit and / or the life-cycle end identification unit. In this way, and when the capture system is equipped with a suitable transmission interface, the data read-disable unit can even be switched to the active state via a remote data connection. Therefore, in the event of the loss of the capture system and / or the drug delivery system equipped with the capture system, and when the user of the corresponding system can no longer physically access at least one of the drug delivery system and the capture system, the data read-disable unit can be activated via a remote data link or via data communication between the transmission interface and the processing unit.

[0071] When the microprocessor is configured to activate the data read disable unit, the microprocessor and the data read disable unit can be provided as separate hardware components. Here, for example, the data read disable unit can be implemented to discharge or deplete the power unit's electrical energy. The data read disable unit can be provided as a separate controller or as an electronically activated switch separate from but controllable by the microprocessor. In other instances, the data read disable unit, when activated, can be operated to detune the transmission interface of the capture system. This detuning can also be provided by a separate electronically controllable switch.

[0072] According to some other examples, a data read disable unit is integrated into the microprocessor. Here, the microprocessor itself is operable to permanently prevent at least one of the following: reading the stored data from the electronic storage unit or providing the stored data from the electronic storage unit. This is particularly applicable to instances where the data read disable unit, and therefore the processing unit, is operable to erase or overwrite the data stored in the electronic storage unit. In other examples, and when the data read disable unit is integrated into the microprocessor, the microprocessor can irreversibly switch to a state preventing data from being read from the electronic storage unit.

[0073] According to another example, the data read disable unit includes at least one of an electronic switch and a mechanical switch. Each of the electronic and mechanical switches is operable to activate the data read disable unit. Therefore, by means of at least one electronic switch and / or at least one mechanical switch, the data read disable unit can be switched to an active state. The switch, i.e., the electronic switch and / or the mechanical switch, can be implemented to irreversibly erase data stored in the electronic storage unit. The switch is operable to trigger a processing unit to initiate or execute a deletion or erasure operation of the data stored in the electronic storage unit. The switch can be user-actuable. In this way, the user can decide to initiate and / or execute the data erasure operation.

[0074] The switch can be actuated by the processing unit. Therefore, activation of the switch can be controlled by software and / or software commands executed by the processing unit. The switch, i.e., at least one of an electronic switch and a mechanical switch, can also be operated to disconnect the processing unit from the power unit and / or, upon actuation, disconnect the power unit from either the processing unit or the electronic storage unit. Furthermore, the switch can be implemented to disconnect the electronic storage unit from the processing unit or vice versa. Any disconnection of the electronic or electrical connection between any of the power unit, processing unit, and electronic storage unit can be irreversible. Once the electronic or electrical connection between one of the power unit, processing unit, and electronic storage unit and another of the processing unit, electronic storage unit, and power unit is disconnected, this disconnected connection cannot be re-established or reconnected.

[0075] In another aspect, this disclosure relates to a data capture device configured for attachment to a drug delivery system. The data capture device is operable to collect data indicating the amount of drug discharged or released from a drug container of the drug delivery system. The data capture device includes a housing and a capture system as described above. The capture system is disposed within or integrated into the housing.

[0076] In some instances, the housing of the data capture device may be attached to and / or secured to the housing of the drug delivery system. The housing of the data capture device may also be integrated into the housing of the drug delivery system. The entire data capture device may be implemented as a component or a unit integrated into the drug delivery system. Two or more of the data capture device and the drug delivery system may be implemented or configured as disposable devices or systems, respectively. Therefore, when the end of the lifecycle of the data capture device and / or the drug delivery system has been reached, the respective device or system is intended to be discarded entirely. Before or during the discarding of the data read-disabling unit of the capture system, activation of the data read-disabling unit may be triggered by direct or remote interaction with the user or autonomously, particularly when the end-of-life configuration of the electronically controlled capture system or the corresponding drug delivery system has been detected or determined.

[0077] According to another aspect, this disclosure also relates to a drug delivery system for discharging or releasing a quantity of liquid medication. The drug delivery system includes a housing configured to contain a drug container filled with the liquid medication. The drug delivery system also includes a drive mechanism operable to discharge or release the quantity of medication from the drug container. The drug delivery system further includes a capture system as described above. Here, the capture system is disposed within or on the housing. The capture system can be integrated into the drug delivery system. Furthermore, the capture system can be integrated into a drug delivery device. The drug delivery device may include an injection or infusion device or may be implemented as an injection or infusion device. The drug delivery system may include an injection pen configured for subcutaneous injection of a liquid medication. When implemented as an injection pen, the drug delivery device, particularly the drug delivery mechanism, includes a piston rod or plunger rod configured to advance distally, i.e., in the dose dispensing direction, to apply thrust to a piston of a cylindrical drug container for discharging a quantity (e.g., a dose) of medication through a distal outlet of the drug container.

[0078] When implemented as an infusion device, the drive mechanism may include a pump configured to, for example, draw or expel a predefined amount, such as a dose of drug or agent, from a drug container by suction. Here, the pump may include a peristaltic pump or a similar pumping mechanism.

[0079] In another example, the drug delivery system further includes a drug container filled with drug and disposed within a housing. The drug delivery system and / or corresponding drug delivery device can be configured or implemented as a pre-filled drug delivery system or device, wherein the drug container is already assembled therein. Such pre-filled drug delivery systems or devices, particularly pre-filled drug injection devices, can be implemented as disposable systems or devices intended to be discarded entirely when the drug provided in the drug container has been used up or should no longer be used.

[0080] According to another aspect, this disclosure relates to a method for preventing the reading or provision of data from an electronic storage unit of a data acquisition system as described above. The method includes the steps of: setting the data reading disable unit to the active state and permanently preventing at least one of the following: reading data from the electronic storage unit or providing data from the electronic storage unit.

[0081] Methods to prevent the reading or provision of data can be implemented by the electronically controlled capture system described above. With regard to any features, benefits, and effects described above in conjunction with the electronically controlled capture system, the same applies to methods to prevent the reading or provision of data from the electronic storage unit; and vice versa.

[0082] According to another aspect, this disclosure also relates to a method for preventing the reading out or provision of data from an electronically controlled capture system. The capture system is operable to capture data in an electronic storage unit. The data represents the amount of drug discharged or released from a drug reservoir by a drug delivery system. The method includes the step of detecting the end of the lifecycle of at least one of the drug delivery system and the capture system. The method further includes the step of activating a data read-disabling unit of the capture system in response to the detection of the end-of-life cycle, and the method further includes the step of permanently preventing at least one of: reading data from the electronic storage unit or providing data from the electronic storage unit. Typically, this method is also configured to be performed by an electronically controlled capture system as described above. With regard to any features, benefits, and effects described above in conjunction with the electronically controlled capture system, the method for preventing the reading out or provision of data from the electronic storage unit is equally applicable; and vice versa.

[0083] Any method of preventing data from being read or provided, including setting the data read disabling unit to an active state or activating the data read disabling unit, is irreversible. Once the data read disabling unit is activated, it cannot be deactivated, or deactivating the data read disabling unit has no effect on restoring the stored data provided in the electronic storage unit.

[0084] Generally, the scope of this disclosure is defined by the claims. The injection device is not limited to a particular embodiment or example, but includes any combination of elements from different embodiments or examples. For this purpose, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in different examples or embodiments.

[0085] In this article, the term "distal" or "far end" refers to the end of the injection device facing the injection site in a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0086] As used in this article, the terms "drug" or "pharmaceutical preparation" refer to a pharmaceutical formulation containing at least one pharmaceutically active compound.

[0087] In one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da, and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or antibody fragment, hormone or oligonucleotide, or a mixture of the above pharmaceutically active compounds.

[0088] In another embodiment, the pharmaceutically active compound may be used to treat and / or prevent diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic diseases (such as deep vein or pulmonary thromboembolism), acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0089] In another embodiment, the pharmaceutically active compound includes at least one peptide for treating and / or preventing diabetes or diabetes-related complications such as diabetic retinopathy.

[0090] In another embodiment, the pharmaceutically active compound includes at least one human insulin or human insulin analog or derivative, glucagon-like peptide-1 (GLP-1) or its analog or derivative, or exendin-3 or exendin-4, or an analog or derivative of exendin-3 or exendin-4.

[0091] Insulin analogs include, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0092] Insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB2 9LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithochyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0093] Venomous exopeptide-4, for example, refers to venomous exopeptide-4 (1-39), a peptide having the following sequence: H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0094] Venomous lizard exopeptide-4 derivatives are selected from the following list of compounds:

[0095] H-(Lys)4-desPro36,desPro37 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0096] H-(Lys)5-desPro36,desPro37 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0097] des Pro36 Venomous Lizard Exopeptide-4(1-39)

[0098] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),

[0099] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),

[0100] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),

[0101] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),

[0102] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0103] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),

[0104] des Pro36[Met(O)14Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0105] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] lizard exopeptide-4(1-39); or

[0106] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),

[0107] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),

[0108] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),

[0109] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),

[0110] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0111] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),

[0112] des Pro36[Met(O)14Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0113] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] Lizard Exopeptide-4(1-39),

[0114] Among them, the group -Lys6-NH2 can bind to the C-terminus of the lizard exopeptide-4 derivative;

[0115] Or a lizard exopeptide-4 derivative having the following sequence:

[0116] des Pro36 Venomous Lizard Exopeptide-4(1-39)-Lys6-NH2(AVE0010),

[0117] H-(Lys)6-des Pro36[Asp28]exotropic peptide-4(1-39)-Lys6-NH2,

[0118] des Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0119] H-(Lys)6-des Pro36,Pro38[Asp28]exotropic peptide-4(1-39)-NH2、

[0120] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-NH2、

[0121] des Pro36,Pro37,Pro38[Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2、

[0122] H-(Lys)6-des Pro36,Pro37,Pro38[Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2、

[0123] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0124] H-(Lys)6-des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-Lys6-NH2、

[0125] H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]exotropic peptide-4(1-39)-NH2、

[0126] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2、

[0127] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2、

[0128] des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0129] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0130] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0131] H-(Lys)6-desPro36[Met(O)14,Asp28]exotropic peptide-4(1-39)-Lys6-NH2、

[0132] des Met(O)14Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0133] H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0134] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0135] des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0136] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0137] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0138] H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-Lys6-NH2,

[0139] H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]exotropic peptide-4(1-39)-NH2、

[0140] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0141] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2、

[0142] des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0143] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(S1-39)-(Lys)6-NH2,

[0144] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2;

[0145] Or a pharmaceutically acceptable salt or solvate of any of the above-mentioned lizard exopeptide-4 derivatives.

[0146] Hormones are, for example, pituitary or hypothalamic hormones or regulatory peptides and their antagonists listed in Chapter 50 of the Rote Liste, 2008 edition, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, gamete maturation hormone), somatropine (growth hormone), desmopressin, terlipressin, gonarelin, triptorelin, leuprorelin, buserrelin, nafarelin, and goserelin.

[0147] Polysaccharides are, for example, glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated forms of the above polysaccharides (e.g., polysulfated forms), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

[0148] Antibodies are globular plasma proteins (approximately 150 kDa), also known as immunoglobulins sharing a basic structure. They are glycoproteins because they have sugar chains added to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimers with two Ig units (such as IgA), tetramers with four Ig units (such as bony fish IgM), or pentamers with five Ig units (such as mammalian IgM).

[0149] Ig monomers are Y-shaped molecules composed of four polypeptide chains; two identical heavy chains and two identical light chains are linked by disulfide bonds between cysteine ​​residues. Each heavy chain is approximately 440 amino acids long; each light chain is approximately 220 amino acids long. Both heavy and light chains contain intrachain disulfide bonds that stabilize their folding. Each chain consists of domains called Ig domains. These domains contain approximately 70–110 amino acids and are categorized according to their size and function (e.g., variable regions or V regions and constant regions or C regions). These domains exhibit a characteristic immunoglobulin fold, where the two β-folds form a "sandwich" shape, held together by interactions between conserved cysteine ​​residues and other charged amino acids.

[0150] There are five types of mammalian Ig heavy chains, denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of the antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0151] The different heavy chains vary in size and composition; α and γ contain approximately 450 amino acids, δ contains approximately 500 amino acids, and μ and ε contain approximately 550 amino acids. Each heavy chain has a constant region (C0). H ) and variable region (V H The heavy chains consist of two regions. Within a species, the constant region is substantially the same across all antibodies of the same isotype, but differs across antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region consisting of three tandem Ig domains and a hinge region for increased flexibility; heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable region of the heavy chains differs across antibodies produced by different B cells, but is identical for all antibodies produced by a single B cell or a B cell clone. Each variable region of the heavy chain is approximately 110 amino acids long and consists of a single Ig domain.

[0152] In mammals, there are two types of immunoglobulin light chains, denoted by λ and κ. A light chain has two continuous domains: a constant domain (CL) and a variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two identical light chains; in mammals, each antibody possesses only one type of light chain, either κ or λ.

[0153] Although all antibodies share a very similar general structure, the unique properties of a given antibody are determined by variable (V) regions, as detailed above. More specifically, variable loops (three on each light chain (VL) and three on each heavy chain (VH)) are responsible for binding the antigen, i.e., for its antigen specificity. These loops are called complementarity-determining regions (CDRs). Because multiple CDRs from the VH and VL domains constitute the antigen-binding site, it is the combination of the heavy and light chains (rather than each individually) that determines the final antigen-specific combination.

[0154] An "antibody fragment" comprises at least one antigen-binding fragment as defined above and exhibits essentially the same function and specificity as the intact antibody derived from it. Restrictive proteolysis with papain cleaves the Ig prototype into three fragments. Two identical N-terminal fragments are antigen-binding fragments (Fab), each containing a complete L-chain and approximately half an H-chain. The third fragment is a crystallizable fragment (Fc), similar in size but containing half of the carboxyl terminus of both heavy chains and their interchain disulfide bonds. Fc contains a carbohydrate, a complement binding site, and an FcR binding site. Restricted pepsin digestion yields a single F(ab')2 fragment containing both a Fab segment and a hinge region, including the HH interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. Furthermore, the variable regions of the heavy and light chains can be fused together to form a single-chain variable fragment (scFv).

[0155] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, salts having cations selected from: alkali or alkaline earth metals, such as Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently represent: hydrogen, optionally substituted C1-C6-alkyl groups, optionally substituted C2-C6-alkenyl groups, optionally substituted C6-C10-aryl groups, or optionally substituted C6-C10-heteroaryl groups. Other examples of pharmaceutically acceptable salts are described in: Remington's Pharmaceutical Sciences, 17th edition, Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.

[0156] Pharmaceutically acceptable solvates are, for example, hydrates.

[0157] It will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from its scope. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of this disclosure. Attached Figure Description

[0158] In the following sections, numerous examples of injection devices including fill level indicators will be described in more detail with reference to the accompanying drawings, wherein:

[0159] Figure 1 shows an example of a drug delivery device.

[0160] Figure 2 shows an example of a drug delivery system that includes a drug delivery device and electronic devices.

[0161] Figure 3 is a detailed illustration of the proximal end of the drug delivery device.

[0162] Figure 4 is a detailed illustration of the proximal end of the drug delivery device having an electronic device attached thereto.

[0163] Figure 5 shows another example of a drug delivery device with integrated electronics.

[0164] Figure 6 is a block diagram illustrating the general working principle of the data read disabling unit.

[0165] Figure 7 is a block diagram of an example of an electronic device.

[0166] Figure 8 is a block diagram of an example of an electronic storage device in an electronic device.

[0167] Figure 9 is a schematic diagram of the data stored in the electronic storage device.

[0168] Figure 10 schematically illustrates an example of preventing data from being read from the electronic storage device.

[0169] Figure 11 schematically illustrates an example of preventing data from being read from the electronic storage device.

[0170] Figure 12 schematically illustrates another example of preventing data from being read from the electronic storage device.

[0171] Figure 13 schematically illustrates another example of preventing data from being read from the electronic storage device.

[0172] Figure 14 schematically illustrates another example of preventing data from being read from the electronic storage device.

[0173] Figure 15 shows a flowchart of the method for preventing data reading out, and

[0174] Figure 16 shows another flowchart of another method to prevent data reading. Detailed Implementation

[0175] As shown in Figures 1 and 2, the injection device 1 can be implemented as a pre-filled, disposable injection device, comprising a housing 10 to which a needle assembly 15 can be attached. The injection needle 24 of the needle assembly 15 is protected by an inner needle cap 16 and an outer needle cap 17 or protective cap 18, the protective cap being configured to close and protect a distal section of the housing 10 of the injection device 1. The housing 10 may include and form a main housing portion configured to house a drive mechanism 30. The injection device 1 may further include a distal housing component, indicated as a drug container holder 14. The drug container holder 14 may be permanently or releasably attached to the main housing 10. The drug container holder 14 is typically configured to contain a drug container 6 filled with a liquid medication. The drug container 6 may include a cartridge that is sealed distally by a puncture-resistant seal (such as a diaphragm).

[0176] As further indicated in Figure 1, the injection device 1 includes a housing 10 and a container 6 filled with a liquid medication. The container 6 provides a drug reservoir or agent reservoir. It may include a generally tubular cylinder or bottle filled with a liquid medication. The agent reservoir 6 may be closed by a repositionable stopper 7 or plug in the proximal direction 3. The stopper 7 may mechanically contact a piston rod 26 of an actuation mechanism 30, which is configured for stepwise or continuous distal displacement to further push the stopper 7 along the distal direction 2 and thus toward the distal outlet of the agent reservoir 6. At or near the outlet, the agent reservoir 6 may include a puncturable membrane. The needle assembly 15 includes a threaded needle seat 22 configured for threaded connection with a threaded socket 20 disposed at the distal end of the drug container holder 14. As shown in Figure 2, the distal end of the drug container holder 14 includes a through opening 21 to receive the proximal tip segment of the injection needle 24. Specifically, the injection device needle 24 of the needle assembly 15 interacts with the needle hub 22 and includes a double-tipped cannula.

[0177] The drive mechanism 30 includes a piston rod 26 operable to push a stopper in a distal direction and displace medication from a medication reservoir 6 (e.g., from a cartridge). The distal end of the piston rod 26 typically includes a pressure member 28 having a radially widened structure compared to the elongated piston rod 26. The pressure member 28 is configured to directly mechanically contact the proximal side of the stopper 7 to displace the stopper 7 relative to the sidewall of the medication reservoir 6. The piston rod 26 may include a screw threaded into the housing 10.

[0178] Figure 2 illustrates an example of a data capture system 100. The data capture system 100 includes a data capture device 102. The structure and possible configurations of the data capture device 102 are shown in more detail in Figures 3-14. The data capture device 102 includes a housing 101. The data capture system 100 and / or the data capture device 102 can be directly attached to and secured to the housing 10 of the drug delivery system or drug delivery device 1. However, mechanically securing the data capture system 100 or the data capture device 102 to the drug delivery device 10 may not be necessary. It may be sufficient when the data capture device 102 or the data capture system 100 is connected to or can be connected to the drug delivery system or drug delivery device 1 via a transmission interface (e.g., a wireless transmission interface). In this way, the data capture system 100 or the data capture device 102 can acquire data 126 from the drug delivery system or drug delivery device 1, wherein the acquired data represents the amount of drug discharged or released from the drug reservoir 1.

[0179] In some instances, the data capture device 102 may be attached to and / or secured to the housing 10, 14 of the drug delivery device 1. For this purpose, at least one of the housings 10, 14 of the drug delivery device 1 and the capture device 102 includes fasteners for releasably or non-releasably connecting and / or attaching the capture device 102 to the drug delivery device 1.

[0180] The drug delivery device 1 includes a dose selector dial 12 and a trigger 11. In the example shown in FIG1, the dose selector dial 12 and the trigger 11 are provided at the proximal end of the housing 10. The injection device 1 further includes a dose window 13, which visually indicates the dose of the currently set medication. To set the dose, the user simply rotates the dose selector dial 12 relative to the housing 10 in the dose increment direction 4. During dose setting, continuously increasing numbers are displayed in the dose window 13. If the currently set dose is too high, the user may also reduce the dose by tossing or rotating the dose selector dial 12 in the opposite direction (i.e., the dose decrement direction 5). Once the appropriate dose size is set or selected, the dose dispensing procedure can be triggered or controlled by pressing the trigger 11 (e.g., forming the proximal end face of the injection device). The trigger 11 can be pressed by the user's thumb.

[0181] As will be further explained below, referring to Figure 7, the data capture system 100 and / or data capture device 102 includes a data transmission interface 111. The data transmission interface 111 can be implemented to establish a communication link with at least one external electronic device 40, 60, 90, as shown in Figure 2. The data communication environment is schematically illustrated therein. By means of the data transmission interface 111, the data capture device 102 can establish a wireless data transmission link to any one of the external electronic devices 40, 60, 90. In the illustration of Figure 2, the external electronic device 40 is implemented as a portable electronic device. It can be implemented as a smartwatch, smartphone, tablet, or similar portable electronic device, operable to communicate wirelessly with the data capture device 102. An additional or alternative external electronic device 60 can be implemented as a non-portable or fixed external electronic device. It can be implemented as a router or an access point providing wireless network access.

[0182] External electronic devices 40 and 60 can be configured to establish another communication link to network 80 (e.g., to the Internet, and thus to database 90). Database 90 can provide electronic storage space for patient or treatment-related data. Database 90 can provide electronic storage space for data backup, particularly for data acquired and stored by an electronically controlled capture system. Wireless communication between wireless transmission interface 111 and external electronic devices 40 and 60 can be based on one of several available wireless data transmission standards, such as Wi-Fi, NFC, RFID, or Bluetooth. Typically, wireless transmission of data between data capture device 102 and any of the external electronic devices 40 and 60 is based on RF broadcast technology.

[0183] In a typical scenario, the data transmission interface 111 can be configured to communicate with external electronic device 40 via a Bluetooth-type wireless connection. It can also communicate with external electronic device 60 via a Wi-Fi wireless communication protocol. The communication link between the data transmission interface 111 and either of the available external electronic devices 40 or 60 can be unidirectional or bidirectional.

[0184] Referring to Figure 3, the dosage setting and dispensing of the drug delivery device are shown in more detail. There, the dosage selector 12 and trigger 11 are part of the selection extension 50. During and / or for setting the dosage, rotating the dosage selector 12 causes longitudinal displacement of the selection extension 50 in the proximal direction 3 relative to the housing 10. During dispensing and when the trigger 11 is pressed in the distal direction 2, the selection extension 50 undergoes longitudinal displacement in the distal direction 2 until it reaches the initial configuration indicated in Figure 1. The selection extension 50 may further include a dosage selector sleeve 52, which includes a plurality of numerical symbols on its outer surface. Such numbers or symbols, as indicated in Figure 3, will be displayed in the dosage window 13 during dosage setting and / or dispensing.

[0185] Figure 4 shows another example of a data capture system 100 and a data capture device 102. The data capture device 102 includes a housing 101, which is attachable to the dose selection extension 50 of the drug delivery device 1. The data capture device 102 includes a trigger 171, which is operatively connected to or operable to the trigger 11 of the drug delivery device 1. As shown in Figure 4, the housing 101 of the data capture device 102 is fixable and attachable to the dose selection disk 12 of the drug delivery device. The housing 101 is torque-transmitted to the dose selection disk 12, and therefore connected to the dose selection disk in a non-slip manner. Therefore, rotation of the housing 101 relative to the housing 10 results in a corresponding rotation of the dose selection disk 12 relative to the housing 10. Depending on the specific implementation of the drive mechanism 30, the dose selection disk 12 may undergo a combination of longitudinal and rotational movement relative to the housing 10 during dose setting and / or dispensing. In other implementations of the drive mechanism 30, the dose selection disk 12 is fixed axially or longitudinally to the housing 10. For dose setting and during dose setting, the dose selector 12 only undergoes rotational movement relative to the housing 10, while it remains axially fixed to the housing 10.

[0186] Figure 5 illustrates another example of the data capture system 100 and the data capture device 102. Here, the data capture device 102 and the data capture system 100 are or are integrated into the housing 10 of the drug delivery device 1. Also here, the drug delivery device 1 is implemented as a handheld and portable injection device. The drug delivery device 1 is implemented electronically or electromechanically. The drug delivery device 1 may include an electric actuator operable to displace the piston rod 26 in the distal direction 2 for dose dispensing and during dispensing.

[0187] The data capture device 102 is integrated into the drug delivery device 1. The data capture device 102 and / or the drug delivery device include a visual output 112, which may be implemented as a display. The data capture device 102 and / or the drug delivery device 1 further include at least one input 110, for example, implemented as a button, for controlling or configuring the operation of the drug delivery device 1 and / or the data capture device 102.

[0188] For any embodiment of the capture system 100 and data capture device 102 shown in Figures 1-5, the electronically controlled capture system 100 or corresponding data capture device 102 includes an electronic circuit 108 as shown in Figure 7. The electronic circuit 108 includes a power unit 116, which includes a power storage unit 117. The electronic circuit 108 further includes a processing unit 114, which can be operated by power obtained from the power unit 116. The electronic circuit 108 further includes an electronic storage unit 118 connected to the processing unit 114. The processing unit 114 is operable to acquire data 126, wherein the data 126 represents the amount, e.g., dosage, of a drug discharged or released from the drug reservoir 6 by the drug delivery system or drug delivery device 1.

[0189] Processing unit 114 is operable to write the acquired data 126 into electronic storage unit 118. Processing unit 114 is also operable to read the stored data 126 from electronic storage unit 118 and provide the stored data 126 from electronic storage unit 118. To provide data 126 to external electronic devices 40, 60, the capture system 100 shown in FIG. 7 further includes a data transmission interface 111. The capture system 100 includes at least one output 112. Output 112 may include a wireless data transmission antenna operable to establish or set up a data communication link with at least one of the external electronic devices 40, 60 via a wireless communication protocol.

[0190] In this manner, and during normal operation, the electronically controlled capture system 100 is operable to repeatedly capture or acquire data 126 and store the corresponding data in the electronic storage unit 118. At fixed time intervals and / or upon request, the processing unit 114 is operable to read data 126 from the electronic storage unit 118, and typically makes the data 126 available to at least one of the external electronic devices 40, 60 via output 112 and / or via data transmission interface 111.

[0191] The capture system 100 and therefore the capture device 102 are also equipped with a data read-disable unit 160. The data read-disable unit 160 is operatively connected to at least one of the processing unit 114, the electronic storage unit 118, and the power unit 116. The data read-disable unit can be switched to an active state. In the active state, the data read-disable unit 160 permanently prevents at least one of the following: reading out of stored data 126 from the electronic storage unit or providing stored data 126 from the electronic storage unit 118. By a typical example, the data read-disable unit 160 is in a deactivated mode by default. It irreversibly switches from the deactivated state to the active state. Therefore, once activated, it cannot be deactivated again, or deactivation has no reversible effect on reading out or providing stored data 126.

[0192] In some instances, the power unit 116 is a limited source of electrical energy. The power unit may include one or more energy storage devices 117. As shown in FIG. 7, the energy storage device 117 may include or be composed of batteries. In some instances, the power unit 116 and / or the energy storage device 117 are non-rechargeable and non-replaceable. In this case, and when the electrical energy supplied and stored in the power unit 116 has been exhausted or consumed, the electronic circuitry 108 and therefore the processing unit 114 are no longer operational.

[0193] Electronic storage cell 118 is shown schematically in more detail in FIG8. Electronic storage cell 118 may include volatile memory 140 and non-volatile memory 142. Both volatile memory 140 and non-volatile memory 142 may include a plurality of memory blocks. In other instances, electronic storage cell 118 may include only non-volatile memory 142 or only volatile memory 140.

[0194] Processing unit 114 typically includes a clock generator 122 operable to provide a time or clock signal for distributing acquired data 126 with time indication or timestamp. Clock generator 122 may be an integral part of processing unit 114. Clock generator 122 may also be provided as a discrete component located away from processing unit 114.

[0195] The data read-disable unit 160 is operatively connected to at least one of the processing unit 114, the power unit 116, and the electronic storage unit 118. In some embodiments, the data read-disable unit 160 is connected to only one or two of the processing unit 114, the electronic storage unit 118, and the power unit 116. In other instances, the data read-disable unit 160 is operatively connected to a connection or data link between any two of the processing unit 114, the electronic storage unit 118, and the power unit 116.

[0196] In any of these ways, the data read disable unit 160 is operable to modify, reconfigure, damage, or destroy the integrity and / or operability of at least one of the power unit 116, processing unit 114, and electronic storage unit 118. Similarly, the data read disable unit 160 is operable to disconnect or destroy the connection between any two of the processing unit 114, power unit 116, and electronic storage unit 118.

[0197] As shown in Figure 6, the power unit 116 is connected to the processing unit 114 via a power supply connection 115. Power or electrical energy from the power unit 116 can be transferred to the processing unit 114 via the power supply connection 115. When properly connected to the power unit 116 via the power supply connection 115, the processing unit 114 is driven by the electrical energy provided by the power unit 116.

[0198] Processing unit 114 is connected to or coupled to electronic storage unit 118 via write data link 106 and read data link 103. Data 126 acquired and provided to processing unit 114 or processed thereby can be written to a suitable storage block in electronic storage unit 118 via write data link 106. Stored data 126 can be read from electronic storage unit 118 via read data link 103.

[0199] The processing unit 114 is also provided with a data transmission interface 111. The data transmission interface 111 enables and provides any type of external communication between the processing unit 114 and any external electronic devices 40, 60. For this purpose, the data transmission interface 111 provides a downlink data link 105 and an uplink data link 104. Through the downlink data link 105, data 126 acquired by the data acquisition system of the capture system 100 or data 126 acquired from the dose-size measurement sensor is provided to the processing unit 114. Data acquired via the downlink data link 105 can be processed by the processing unit 114 and can be stored in the electronic storage unit 118 via the write data link 106. Conversely, data 126 read from the electronic storage unit 118 and provided to the processing unit 114 via the read data link 103 can be transmitted via the data transmission interface 111 at both ends of the uplink data link 104 and by means of the uplink data link.

[0200] To prevent misuse of the stored data 126 stored in the electronic storage unit 118 at the end of the lifecycle of the capture system 100 and / or the drug delivery system 1, the data read disable unit 160 provides at least one of a number of methods to permanently prevent at least one of the following: reading out of or providing the stored data 126 from the electronic storage unit 118.

[0201] Using a method, the data readout disable unit 160 is operable to manipulate or reconfigure the power unit 116. Here, the data readout disable unit 160 is operable to prematurely discharge or deplete the power from the power unit. Here, the power unit 116 is a limited energy storage device. The power unit 116 is non-rechargeable and non-replaceable integrated into the electronic circuitry. When the data readout disable unit 160 is activated, it causes the power unit 116 to deplete or discharge. Then, the capture system 100 will no longer have sufficient power to read data 126 from the electronic storage unit 118.

[0202] In another example, the data read disable unit 160 is operable to disconnect or damage the power supply connection 115 between the power unit 116 and the processing unit 114. Here, the processing unit 114 does not have its own power supply. By irreversibly disconnecting and / or irreversibly damaging the power supply connection 115, the processing unit 114 is permanently shut down and cannot be set back to operating mode. In this way, the reading of the data 126 stored in the electronic storage unit 118 is permanently prevented.

[0203] In another example, the data read disable unit 160 is operable to trigger or reconfigure the processing unit 114. Therefore, the data read disable unit 160 is operable to switch the processing unit 114 into a data erase mode. When switched to data erase mode, the processing unit 114 is operable to erase the data 126 in the electronic storage unit 118. Here, the data may be overwritten by some other data or random data. Overwriting the memory unit or storage unit provides permanent deletion of the data 126 previously stored in the electronic storage unit 118.

[0204] In another example, processing unit 114 is equipped with or includes an encoder 124 or a decoder. Encoder 124 is operable to encode or encrypt data 126 stored in electronic storage unit 118. Therefore, when triggered by data read disable unit 160, processing unit 114 is operable to encrypt or encode data 126 stored in electronic storage unit 118. Encryption can be based on a key. The key can be randomly generated by processing unit 114. After data encryption is complete, the key can be deleted by processing unit 114. Without a matching key, data 126 stored in electronic storage unit 118 is undecodeable and cannot be decrypted. Even if data 126 remains stored in electronic storage unit 118 in encrypted format, it cannot be read or accessed.

[0205] In another example, each default processing unit 114 stores the acquired data 126 in the electronic storage unit 118 only in encrypted format. For the reading of data 126, the processing unit 114 performs decryption of the data before it is transmitted to external electronic devices 40, 60 via output 112. Here, and when appropriately triggered by the data read disable unit, the processing unit 114 can be configured to delete the decoding or decryption key, so that data previously stored in the electronic storage unit 118 in encrypted format can no longer be decrypted.

[0206] In this scenario, and when the data stored in the electronic storage unit 118 is encrypted or will be encrypted upon reaching the end of its lifespan, the corresponding key 144 for encryption or decryption can be stored in the volatile storage 140 of the electronic storage unit 118. During normal operation and as long as the data read disabling unit is in a deactivated state, the processing unit 114 can read or retrieve the key 144 from the volatile storage 140 to decode or decrypt the stored data 126 during the execution or performance of a data read process. In this example, and when the data read disabling unit 160 is configured to deplete or consume electrical energy from the power unit 116, and / or when the power supply between the power unit 116 and the electronic storage unit 118 is disconnected when the data read disabling unit is activated, the key 144 in the volatile storage device 140 is irreversibly lost. Therefore, even if someone attempts to supply power to the processing unit 114, it will no longer be possible to decrypt the stored data 126.

[0207] According to another example, the data read disable unit 160 is operable to erase or overwrite the stored data 126 in the electronic storage unit 118. In another example, the data read disable unit 160 is operable to disconnect or damage the read data link 103, through which the stored data 126 can be transferred from the electronic storage unit 118 to the processing unit 114. Here, the data read disable unit 160 can be configured to irreversibly disconnect or irreversibly damage the read data link 103. Since the electronic storage unit 118 does not have any additional data link configured to retrieve data from the storage device, reading the data stored in the electronic storage unit 118 is effectively prevented.

[0208] In other instances, the data read disable unit 160 is operable to modify or reconfigure, for example, to detune the uplink data link 104 when switched to an active state. In this way, the processing unit 114 can maintain the ability to read the stored data 126 from the electronic storage unit 118, even if the data read disable unit has been switched to an active state. However, the data 126 read by and provided to the processing unit 114 cannot be further or retransmitted to any of the external electronic devices 40, 60. Here, the data read disable unit 160 is operable to detune the data transmission frequency or carrier frequency of the wireless communication link between the data transmission interface 111 and a corresponding matching data transmission interface of one of the external electronic devices 40, 60.

[0209] Figures 10-14 show some examples of a data read disable unit 160, which is operable to irreversibly switch to an active state, wherein data readout or transmission of stored data is permanently blocked or prevented.

[0210] For simplicity, only a few components of electronic circuit 108 are shown in Figures 10-14. In the example of Figure 10, power unit 116 is a limited storage device for electrical energy. It includes a non-rechargeable battery. Processing unit 114 includes microprocessor 113, which is electrically connected to and driven by power unit 116. Power management 150 including electronic switch 152 is also provided. The electronic switch may include one or more transistors, such as field-effect transistors or bipolar transistors, such as MOSFETs, JFETs, or FETs. Power management 150 may further include numerous discrete electronic components, such as resistors or capacitors not shown in more detail here.

[0211] Electronic switch 152 can be switched from a disabled state to an active state. In the disabled state, the two input ports of microprocessor 113 are electrically connected to the two ports or poles of energy storage 117. When electronic switch 152 is switched to the active state, the input ports of microprocessor 113 are effectively disconnected from energy unit 116, and therefore disconnected from energy storage 117. Here, by switching electronic switch 152 to the active state, data read disable unit 160 is also switched to the active state.

[0212] Processing unit 114 and therefore microprocessor 113 are irreversibly disconnected from power. Alternatively, a mechanical switch 162, as indicated in FIG5, can be implemented instead of electronic switch 152. Both electronic switch 152 and / or mechanical switch 162 can be manually actuated by the user of capture system 100 to irreversibly disconnect processing unit 114 from power unit 116.

[0213] In an alternative example shown in Figure 11, power management 150 includes a power management integrated circuit 156 (power management IC), which can be switched via corresponding outputs of processing unit 114 and / or microprocessor 113. Therefore, when the end of its lifecycle has been reached or detected, processing unit 114 can trigger power management IC 156 to permanently disconnect processing unit 114 from power unit 116. The power management IC may include one of a DDS chip, a boost converter and a buck converter, a low-dropout regulator, a buck converter, a boost converter, or a current driver circuit.

[0214] In another example of the data read disable unit 160 shown in Figure 12, the processing unit 114 and / or the corresponding microprocessor 113 are operable to shut themselves down. Here, one or more output ports of the microprocessor 113 can be switched or activated at the end of its lifecycle, causing the processing unit 114 to irreversibly enter a lifecycle-end mode from which it cannot be recovered. For example, the microprocessor 113 may include a reset pin or an on / off pin, thereby allowing the microprocessor 113 to be permanently shut down or irreversibly set to a sleep mode.

[0215] In another example, as shown in Figure 13, the data readout disable unit 160 is configured to detun or modify the output 112 of the data transmission interface 111. For this purpose, and upon reaching the end of its lifespan, the data readout disable unit 160 and / or processing unit 114 are operable to activate the electronic switch 152, thereby permanently detuning or connecting the impedance of the antenna 158 to ground. The antenna 158 may represent or provide at least one of an uplink data link 104 and a downlink data link 105. By irreversibly modifying the antenna 158, wireless communication links with any external electronic devices 40, 60 can be effectively prevented. The data 126 stored in the electronic storage unit 118 cannot be transmitted to any external electronic devices 40, 60.

[0216] As another example and as shown in Figure 14, the data readout disable unit 160 includes an electrical load 154, for example, in the form of an electrically operable light source (e.g., an LED). An electronic switch 152, which can be activated by the processing unit 114 and / or by the microprocessor 113, is also provided. Upon detecting the end of its lifecycle or an end-of-lifecycle configuration, the data readout disable unit 160 (e.g., the processing unit 114) can be configured to turn on the electronic switch, thereby causing a reduction in the power supply unit 116 via the electrical load 154. Here, this provides for the premature depletion or dissipation of electrical energy in the power supply unit 116. The electronic circuit 108 is depleting its power.

[0217] It should be noted that any electronic switch 152 shown in any of Figures 10-14 may be electronically implemented and may be switchable or actuated by the microprocessor 113 and / or by the processing unit 114 itself. In all the illustrated examples, it is generally conceivable to replace the electronic switch 152 with a mechanical switch 162 that can be actuated by the user of the device. The mechanical switch 162 may be provided with or equipped with a reuse preventer or a reactivation preventer. Therefore, when the mechanical switch has been actuated to switch the data read disable unit 160 to the active state, a reverse switch of the data read disable unit from the active state back to the deactivated state is not possible. The reuse preventer of the mechanical switch may include a perforated mechanical structure configured to irreversibly disintegrate when the switch is actuated. Furthermore, the mechanical switch 162 may include an irreversibly removable flap or strip that cannot be reattached to the mechanical switch when detached or peeled from the data capture device 102.

[0218] Figure 9 illustrates an example of the structure of stored data 126 stored in electronic storage unit 118. Numerous storage blocks are provided, shown as rows with consecutive numbering. For each row, dosage or drug delivery information is provided. Each row is set with, for example, a timestamp generated by clock generator 122 and the amount of drug actually discharged or released from drug reservoir 6. In the example of Figure 9, the dosage is given as an integer.

[0219] Each storage block is represented by a number. For example, storage block 93 indicates the amount of 20 units of medication or drug that was administered at 8:03 AM. Subsequent storage block 94 indicates the amount of 30 units that was administered at 8:05 PM. Data 126 shown in Figure 9 can represent a dosing regimen. Here, the patient may have to administer 20 units at 8:00 AM and 30 units at 8:00 PM each day. Data 126 can be stored entirely in the non-volatile storage 142 of electronic storage unit 118. It is also conceivable that only some of the data 126 is stored in the non-volatile storage 142, while other data, such as non-recent or older data, such as storage blocks 93, 94, and 95, is stored in the volatile storage 140. In this configuration, and when the data read disable unit 160 is operable to prematurely deplete power or disconnect the power unit 116 from the processing unit 114 and / or from the electronic storage unit 118, only the most recent data, such as data in storage blocks 99, 98, 97, and 96, can be read in principle. In this way, the care provider can always obtain or read the latest administration-related data from the electronic storage unit 118. This can be extremely useful in emergency situations where information about actual or recent medication administration may be very valuable and important.

[0220] The data 126 stored in the electronic storage unit 118 can be further analyzed to estimate the dosing regimen. For example, and using the data shown in Figure 9, the capture system can be operated to determine or estimate a dosing regimen, such as administering 20 units at 8:00 AM and 30 units at 8:00 PM. If the data 126 now acquired by the processing unit 114 deviates significantly from the estimated dosing regimen, this may be an indication that the capture system and / or drug delivery system is no longer in use, especially when the currently due dosing action has not been performed or cannot be detected even several hours after the due date or time. This determination that the use of the drug delivery system does not conform to the estimated or predefined dosing regimen can serve as a trigger indicating that the capture system and / or drug delivery system 1 has reached the end of its lifecycle.

[0221] In many instances, the capture system 100 shown in FIG7 is equipped with a lifecycle end identification unit 120. This lifecycle end identification unit is operable to determine and / or indicate the lifecycle end of at least one of the capture system 100 and the drug delivery system. The lifecycle end identification unit 120 is operablely connected to a data readout disable unit 160. The lifecycle end identification unit 120 is operable to set the data readout disable unit 160 to an active state. In this way, and once the lifecycle end configuration of at least one of the drug delivery system 1 and the capture system 100 is detected or determined, the data readout disable unit 160 can be automatically switched to an active state by the lifecycle end identification unit 120, thereby preventing the reading or provision of stored data 126 from the electronic storage unit 118.

[0222] The lifecycle end identification unit 120 may optionally be equipped with a sensor 130, such as an environmental sensor. The sensor 130 may also be operable to determine the fill level of the drug container 6. The sensor 130 may be further configured to determine or detect the instantaneous configuration of the drive mechanism 30 of the drug delivery system 1 or drug delivery device. Specifically, the sensor 130 may be configured to determine the axial or longitudinal position of the piston rod 26 relative to the drug container 6 or relative to the housing 10.

[0223] Furthermore, sensor 130 can be implemented as an environmental sensor operable to determine at least one of temperature, pressure, humidity, motion, orientation, the presence and / or intensity of electromagnetic radiation, and the integrity of the drug delivery system or drug delivery device. For example, if sensor 130 is operable to determine or detect disassembly of the drug delivery device, this can be detected by detector 130 when the drug delivery device is disassembled. Therefore, lifecycle end identification unit 120 will appropriately detect that the device has been disassembled and has reached the end of its lifecycle period. Therefore, lifecycle end identification unit 120 is operable to switch data read disable unit 160 to an active state, thereby prohibiting the reading or provision of previously acquired and / or stored data.

[0224] The lifecycle end identification unit 120 may optionally include a controller 132 and / or a data exchange detector 134. In this way, many other scenarios and situations indicating the end of the lifecycle can also be performed. With the aid of the controller 132 and the data exchange detector 134, the lifecycle end identification unit 120 can determine, detect, or record the establishment of data communication between the data capture system 100 and external electronic devices 40, 60 over time. Here, the maximum amount of data exchange can be set and / or stored in the lifecycle end identification unit 120. If the maximum allowed amount of data has been exchanged, the lifecycle end identification unit 120 is operable to set or switch the data read disable unit 160 to an active state.

[0225] Furthermore, and by way of another example, the lifecycle end identification unit 120 may include a counter 121. The counter 121 is operable to determine at least one of the following: the number of times the drug delivery system or drug delivery device 1 has been used, the time since one of the drug delivery system or device and the capture system 100 was first used, and / or the number of replaceable drug containers used with the drug delivery system. In this way, other criteria for determining the lifecycle end of the capture system and / or the drug delivery system or drug delivery device may be implemented. For example, the lifecycle end identification unit 120 may be configured to count the number of doses or uses of the drug delivery system 1. If, for example, a predefined maximum allowable number of uses has been exceeded or reached, such as 200 uses, then the lifecycle end identification unit 120 is operable to switch the data read disable unit 160 to an active state, thereby disabling the reading of stored data 126.

[0226] Similarly, and when the electronically controlled capture system 100 is equipped with a non-rechargeable, limited energy storage unit 117 (known to last for a predetermined time interval from the first activation of the capture system), the counter 121 is operable to record the time from the first activation date or time. Before or at the time when the energy unit is guaranteed to last for a predetermined time, the lifecycle end identification unit 120 may trigger a final backup procedure for the data 126 stored in the electronic storage unit 118, and may further trigger the subsequent activation of the data read disable unit 160.

[0227] The lifecycle end identification unit 120 is operatively connected to at least one of the data read disable unit 160 and the processing unit 114. In some cases, this may be advantageous when the lifecycle end identification unit 120 is connected only to the processing unit 114. The processing unit 114 can then trigger a final conversation or communication with the user of the drug delivery device 1 before the data read disable unit 160 is irreversibly activated. In this way, the user is given the possibility of over-control, such as the autonomous activation of the data read disable unit 160 or manual triggering of final data erasure.

[0228] The block diagram of the capture system 100 according to Figure 7 is illustrative only. The data readout disable unit 160 can be fully integrated into the processing unit 114. The processing unit 114 and the electronic storage unit 118 can be fully integrated into the electronic circuit 108. The electronic circuit 108 can be implemented in the microprocessor 113.

[0229] Figure 15 illustrates three consecutive steps 200, 202, and 204 of a method for preventing the reading or provision of data from the electronic storage unit 118 of the data acquisition system 100. In the first step 200, the end of the lifecycle of the drug delivery system 1 or drug delivery device has been detected or determined by the user of the respective device. In step 202, the data reading disable unit 160 is switched to an active state. Subsequently, and in step 204, when the data reading disable unit 160 is activated, at least one of the following is permanently prevented: reading the stored data 126 from the electronic storage unit 118 or providing the stored data 126 from the electronic storage unit 118. The detection of the end of the lifecycle in step 200 can be performed according to any of the methods and schemes described above. The activation of the data reading disable unit 160 in step 202 can be performed according to any of the steps and schemes described above, and the prevention of data reading or data provision in step 204 can also be performed in any of the manner described above.

[0230] In another flowchart of the method for disabling the reading or provision of data from the electronically controlled capture system shown in Figure 16, in the first step 300, the lifecycle end identification unit 120 is in a loop mode by default and repeats steps 300 and 302. In step 300, sensor data or other input data is processed. In the subsequent step 302, the processed data is verified, for example, by comparing it with predefined or stored data, to determine whether the lifecycle end configuration has been reached. If the lifecycle end configuration has not been reached, the method returns to step 300, in which further data regarding the use of the drug delivery system or drug delivery device 1 is generated and / or processed. If, in step 302, the lifecycle end identification unit 120 determines that the lifecycle end configuration has been reached, the method continues to step 304. In step 304, the data reading disable unit 160 is switched to an active state, with the aforementioned consequences regarding the reading or provision of stored data.

[0231] By way of other examples, the mechanical switch 162 or electronic switch 152 described above can also be integrated or implemented into one of the trigger 11 and the dose selector 12. This is particularly applicable to the injection device 1 shown in FIG. 5. Here, the trigger 11 and / or the dose selector 12 can be connected to an input 110, which is operatively connected to the processing unit 114. The input 110 may include one or more sensors or switches mechanically connected to the trigger 11 and / or the dose selector 12.

[0232] Numerous encoding schemes may exist for using or operating the dose selector 12 and / or trigger 11, which are interpreted by the processing unit 114 as switching the data read disable unit to an active state. For example, pressing and releasing the trigger 11 twice within a predefined time interval can be interpreted by either the processing unit 114 or the life-cycle end identification unit 120 as a life-cycle end signal. When detected and correctly interpreted, at least one of the processing unit 114 and the life-cycle end identification unit 120 is operable to switch the data read disable unit 160 to an active state. In response to the data read disable unit 160 switching to an active state, stored data 126 can be deleted from the electronic storage unit 118.

[0233] In another embodiment of the defined lifecycle end configuration, trigger 11 can be pressed and released twice without selecting the dose between the first and second press actions. Thereafter, the dose selection dial 12 is set to arbitrary units and thus selected as arbitrary units in the dose increment direction. Subsequently, the dose selection dial 12 is dialed in the opposite direction and returns to the zero-dose configuration. To confirm deletion or lifecycle end configuration, trigger 11 is pressed again.

[0234] In another example, the dose selector dial 12 is set to any unit greater than 1. Within a predefined time interval after reaching a predefined dose value, the dose selector dial is turned back in the dose-decreasing direction until a zero-dose configuration is reached again. In this zero-dose configuration, the trigger is pressed once. Then, after the predefined time interval has elapsed, the trigger is pressed a second time. This use case can also be interpreted as a lifecycle end signal, by which the processing unit 114 and / or the lifecycle end identification unit 120 trigger the data read disable unit 160 to switch to an active state.

[0235] In another example, the dose selector dial 12 is moved to a predefined dose size in the dose increment direction. It is then moved to the initial zero-dose configuration in the opposite direction, i.e., the dose decrement direction. Trigger 11 is then pressed once. To confirm the activation of the data readout disable unit 160, the dose selector dial 12 is moved to the predetermined dose size and then moved in the opposite direction until the zero-dose configuration is reached again.

[0236] These and other examples are generally applicable to drug delivery devices 1 with an integrated capture system 100, wherein the flicking of a dose selector 12 and the pressing of a trigger 11 are electronically detected and / or quantitatively measured.

[0237] In another example, the capture system 100 is equipped with a torque sensor. This torque sensor is an example of sensor 130 belonging to the life-cycle end recognition unit 120 shown in FIG. 7. A tactile stop can be provided to define the zero-dose position of the dose selector disc. In one scenario of use, when in a zero-dose configuration, the dose selector disc 12 rotates in the dose-decreasing direction. Here, the stop prevents the dose selector disc 12 from being turned in the dose-decreasing direction. However, the torque applied by the user to the dose selector disc 12 and against the stop is measured by the torque sensor. If the user holds or rotates the dose selector disc 12 against the tactile end-of-life stop for a period of time exceeding a predefined time interval, this will be interpreted as a life-cycle end signal. Therefore, the processing unit 114 and / or the life-cycle end recognition unit 120 will be operable to switch the data reading disable unit 160 to an active state.

[0238] In another example, the rotary dose selector button is pressed against a tactile stop during a predefined time interval, such as one second or more. The dose selector 12 remains in this button configuration. To confirm the activation of the data readout disable unit 160, the user must then press the trigger 11 once.

[0239] In another example, the dose selector 12 rotates against the zero-dose stop and remains in this zero-dose configuration for a predefined time interval, such as greater than or equal to one second. Before the data readout disable unit switches to the active state, the user must confirm the detected rotation of the dose selector 12, for example, by rotating the dose selector 12 in the dose increment direction 4 until a predefined or arbitrary dose has been set, and then by subsequently rotating the dose selector 12 in the opposite dose decrement direction 5 until the zero-dose configuration is reached again.

[0240] For confirmation of switching the data reading disable unit 160 to the active state, it is even conceivable that the dose selector 12 is released after rotating against the mechanical stop within a predefined time interval. Therefore, no torque should be applied to the dose selector 12 for the second predefined time interval. Thereafter, the dose selector 12 can be rotated repeatedly against the stop and can remain in this stop configuration for a third predefined time interval. The first, second, and third time intervals can be greater than or equal to one second.

[0241] In some other instances, user-initiated end-of-lifecycle activation or user-activated data read disable unit 160 can be achieved using a drug delivery device 1 with an integrated capture system 100, as shown in Figure 5, for example. There, trigger 11 can be pressed for a period of time, for example, during a predefined time interval, until output 112 (e.g., in display form) indicates to the user that the data erasure mode has been activated. To confirm data erasure, the user may have to press trigger 11 again.

[0242] In another instance, trigger 11 must be pressed at least once. Afterward, the dose selector dial 12 must be rotated against the zero-dose stop. It is held in the zero-dose stop until the erase mode is indicated in output 111. To confirm data erasure, trigger 11 must be pressed at least one more time.

[0243] In another instance, and in order to activate the erasure of data 126, trigger 11 must be pressed at least once. Afterward, the dose dial 12 rotates against the zero-dose stop and remains in this zero-dose position until the erasure mode is activated. To confirm the erasure action, the dose dial 12 must again rotate against the zero-dose stop and must remain in this configuration or position for a predetermined time interval.

[0244] Using another example, the erasure or deletion of data 126 can be triggered by a user by rotating the dose dial 12 against the zero-dose stop at predetermined time intervals (e.g., greater than or equal to one second). The dose dial 12 remains in this configuration until, for example, the erasure mode is activated by output 112. To confirm the erasure of data, trigger 11 must be pressed at least once.

[0245] In another example, after activating the erase mode as described above for confirming data erasure, the dose selector dial 12 is rotated again against the zero-dose stop and held in this configuration until output 112 confirms data erasure. To indicate the activation of the erase mode and / or to indicate the completion of the data erasure operation, output 112 may include a display or at least one or more light-emitting elements, such as LEDs configured to flash in continuous, interrupted, or repetitive modes. Many or a single LED may also be configured to illuminate in one or more colors to indicate the activation of the data erase mode and / or to indicate the completion of data deletion or erasure.

[0246] List of reference numerals

[0247] 1. Drug delivery device

[0248] 2. Distal direction

[0249] 3. Proximal direction

[0250] 4. Direction of dose escalation

[0251] 5. Direction of dose reduction

[0252] 6. Medicine containers

[0253] 7. Plugs

[0254] 10. Shell

[0255] 11 Triggers

[0256] 12 Dosage Selection Panel

[0257] 13 Dosage window

[0258] 14. Drug container holder

[0259] 15-pin assembly

[0260] 16 Inner pin cap

[0261] 17. Outer pin cap

[0262] 18 Protective Helmets

[0263] 19 windows

[0264] 20 threaded socket

[0265] 21 Through opening

[0266] 22 needle hubs

[0267] 24 Injection needles

[0268] 26 Piston rod

[0269] 28 Pressure components

[0270] 30 Drive mechanism

[0271] 40 External electronic devices

[0272] 50 Selection Extension Section

[0273] 52 Dosage Selection Sleeve

[0274] 60 External electronic devices

[0275] 80 Network

[0276] 90 Databases

[0277] 100 capture system

[0278] 101 Casing

[0279] 102 Data capture device

[0280] 103 Data Link

[0281] 104 Data Link

[0282] 105 Data Link

[0283] 106 Data Link

[0284] 110 input

[0285] 111 Data Transmission Interface

[0286] 112 Output

[0287] 113 microprocessor

[0288] 114 Processing Units

[0289] 115 Power supply connection

[0290] 116 electrical energy units

[0291] 117 Energy Storage Device

[0292] 118 electronic storage units

[0293] 120 Lifecycle End Identification Unit

[0294] 121 counter

[0295] 122 Clock Generator

[0296] 124 Encoder / Decoder

[0297] 126 data

[0298] 130 sensor

[0299] 132 controller

[0300] 134 Data Exchange Detector

[0301] 140 Volatile Storage

[0302] 142 Non-volatile storage

[0303] 144 key

[0304] 150 Power Management

[0305] 152 Electronic Switch

[0306] 154 Electrical Load

[0307] 156 Power Management IC

[0308] 158 antennas

[0309] 160 Data Reading Disabled Unit

[0310] 162 Mechanical Switch

[0311] 171 trigger

Claims

1. An electronically controlled capture system (100) for capturing data (126) representing the amount of drug discharged or released from a drug reservoir (6) via a drug delivery system (1), the capture system (100) comprising electronic circuitry (108) including: - An electrical energy unit (116) comprising an energy storage device (117), - A processing unit (114) that is operable by power obtained from the power unit (116), the processing unit (114) being operable for acquiring data (126). - An electronic storage unit (118) connected to the processing unit (114), the electronic storage unit (118) being configured to store acquired data (126), The processing unit (114) is operable to write the acquired data (126) into the electronic storage unit (118), and the processing unit (114) is operable to read the stored data (126) from the electronic storage unit (118) and provide the stored data (126) from the electronic storage unit (118). - A data read-disable unit (160), operably connected to at least one of the processing unit (114), the electronic storage unit (118), and the power unit (116), wherein the data read-disable unit (160) is irreversibly switchable to an active state, wherein in the active state, the data read-disable unit (160) permanently prevents at least one of the following: - Read the stored data (126) from the electronic storage unit (118), or - The stored data (126) is provided from the electronic storage unit (118), and - A lifecycle end identification unit (120) operable to determine and / or indicate the lifecycle end of at least one of the capture system (100) and the drug delivery system (1), wherein the lifecycle end identification unit (120) is operablely connected to the data read disable unit (160), and wherein the lifecycle end identification unit (120) is operable to set the data read disable unit (160) in the active state.

2. The capture system according to claim 1, wherein the energy storage device (117) is a finite energy storage device and / or the energy storage device is non-rechargeable.

3. The capture system according to any one of claims 1-2, wherein the data read disable unit (160) is operable to disconnect the processing unit (114) from at least one of the electronic storage unit (118) and the power unit (116) when in the active state.

4. The capture system according to any one of claims 1-2, wherein the data read disable unit (160) is operable to disconnect the power unit (116) from the processing unit (114) when in the active state.

5. The capture system according to any one of claims 1-2, wherein the data readout disable unit (160) is operable to discharge the power unit (116) when in the active state.

6. The capture system according to any one of claims 1-2, wherein the data read disable unit (160) is operable to delete stored data (126) from the electronic storage unit (118) when in the active state.

7. The capture system according to any one of claims 1-2, wherein the data read disabling unit (160) is operable to irreversibly encrypt the acquired data or the stored data (126) in the electronic storage unit (118) when in the activated state.

8. The capture system according to any one of claims 1-2, wherein the data read disable unit (160) is operable to prevent the decryption of the stored data (126) when in the active state, wherein the stored data (126) is stored in the electronic storage unit (118) in an encrypted format.

9. The capture system according to claim 8, wherein the encryption key or decryption key is stored in the volatile storage block (140) of the electronic storage unit (118), and wherein when the data read disabling unit (160) is activated, the encryption key or decryption key is deleted or the power supply to the electronic storage unit (118) is cut off.

10. The capture system according to any one of claims 1-2, further comprising a data transmission interface (111) connected to the processing unit (114) and capable of being connected to an external electronic device (40, 60), wherein the data read disable unit (160) is operable to interrupt or disable the data transmission connection between the processing unit (140) and the data transmission interface (111).

11. The capture system according to claim 1 or 2, wherein the life cycle end identification unit (120) is operable to determine the available electrical energy of the power unit (116), and wherein the life cycle end identification unit (120) is operable to compare the available electrical energy with a predefined minimum electrical energy of the power unit (116).

12. The capture system according to claim 1 or 2, wherein the lifecycle end identification unit (120) includes a counter (121) operable to determine at least one of the following: - Number of times the drug delivery system (1) is used, -The time since one of the drug delivery system (1) and the capture system (100) was first used, - The number of replaceable drug containers (6) used with the drug delivery system (1).

13. The capture system according to claim 1 or 2, wherein the life cycle end identification unit (120) is operatively connected to at least one sensor (130), the at least one sensor (130) being operatively configured to determine at least one of temperature, pressure, humidity, motion, orientation, presence and / or intensity of electromagnetic radiation, and integrity of the drug delivery system (1).

14. The capture system according to claim 1 or 2, wherein the lifecycle end identification unit (120) includes a controller (132) operable to: - Detect user-initiated actions of the drug delivery system (1), including dispensing a dose of drug. - Record user-initiated actions over time. - Estimate the drug administration regimen based on recorded user-initiated actions, the administration regimen including at least one periodicity and time or time window of the user-initiated actions for the drug delivery system (1), and - Determine the inconsistency between the use of the drug delivery system (1) and the estimated dosing regimen.

15. The capture system of claim 14, wherein the controller (132) is integrated into the processing unit (114).

16. The capture system according to claim 1 or 2, wherein the lifecycle end identification unit (120) includes a data exchange detector (134) operable over time to detect and / or record data communication established between the capture system (100) and external electronic devices (40, 60).

17. The capture system according to claim 1 or 2, wherein the lifecycle end identification unit (120) is integrated into the processing unit (114).

18. The capture system according to any one of claims 1-2, wherein the processing unit (114) is provided by a microprocessor (113) or wherein the processing unit (114) is implemented in the microprocessor (113).

19. The capture system of claim 18, wherein the microprocessor (113) is configured to set the data read disable unit (160) to an active state.

20. The capture system according to claim 18 or 19, wherein the data read disable unit (160) is integrated into the microprocessor (113).

21. The capture system according to any one of claims 1-2, wherein the data readout disable unit (160) comprises at least one of an electronic switch (152) and a mechanical switch (162), each of the electronic switch and the mechanical switch being operable to switch the data readout disable unit (160) to the active state.

22. A data capture device (102) configured for attachment to a drug delivery system (1), the data capture device (102) being operable to collect data (126) indicating the amount of drug discharged or released from a drug container (6) of the drug delivery system (1), the data capture device (102) comprising: -Shell (101), - The capture system (100) according to any one of the preceding claims.

23. A drug delivery system for discharging or releasing a certain amount of liquid drug, the drug delivery device system comprising: - A housing (10) configured to contain a drug container (6) filled with the liquid drug, - A drive mechanism (30) operable to discharge or release the specified amount of the drug from the drug container (6), and - The capture system (100) according to any one of the preceding claims 1-21 is disposed within or on the housing (10).

24. The drug delivery system of claim 23, further comprising a drug container filled with a drug and disposed within the housing (10).

25. A method for preventing the reading or provision of data (126) from an electronic storage unit (118) of a capture system (100) according to any one of claims 1-21, the method comprising: - Set the data reading disable unit (160) to the active state, and - Permanently prevent at least one of the following: reading data (126) from the electronic storage unit (118), or providing data (126) from the electronic storage unit (118).

26. A method for preventing the reading out or delivery of data (126) from an electronically controlled capture system (100), wherein the capture system (100) is operable to capture data (126) in an electronic storage unit (118), the data (126) representing the amount of drug discharged or released from a drug reservoir (6) by a drug delivery system (1), the method comprising: - Detect the lifecycle end of at least one of the drug delivery system (1) and the capture system (100), - The data read disabling unit (160) of the capture system (100) is irreversibly activated in response to the detection of the end of the lifecycle. - Permanently prevent at least one of the following: reading data (126) from the electronic storage unit (118) or providing data (126) from the electronic storage unit (118).

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