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EP-3710082-B1 - WIRELESS ELECTRONICS ASSEMBLY FOR INJECTION DEVICES

EP3710082B1EP 3710082 B1EP3710082 B1EP 3710082B1EP-3710082-B1

Inventors

  • DIEFENBACH, Holger

Dates

Publication Date
20260513
Application Date
20181112

Claims (15)

  1. An electronics assembly (340) for use in a drug delivery device (100), comprising: a processor (343); a sensor (341) arranged to measure a fill level of a drug container of the drug delivery device (100) and output a measurement signal to the processor (343) ; a wireless module (345) to which an external device (480) can be paired; a power module (346) arranged to supply power to the sensor (341), the processor (343), and the wireless module (345); and at least one non transitory computer readable medium storing instructions characterized in that the non transitory computer readable medium is operable to cause the processor (343) to perform operations comprising: activating the sensor (341) at a first frequency and receiving the measurement signal, determining, based on the received measurement signal, if the drug container contains medicament, when the drug container is determined to contain medicament, switching the activating of the sensor (341) at the first frequency to activating the sensor (341) at a second frequency and receiving the measurement signal, wherein the second frequency is higher than the first frequency, for each activating of the sensor (341) at the second frequency, determining, based on the received measurement signal, a change in the fill level of the drug container, and when the change in the fill level is detected, activating the wireless module (345) for a first duration to enable the external device (480) to pair with the wireless module (345).
  2. The electronics assembly (340) of claim 1, wherein the instructions stored on the at least one non transitory computer readable medium include: when the wireless module (345) is paired, transmitting the change in the fill level of the drug container to the external device (480) and deactivating the wireless module (345).
  3. The electronics assembly (340) of any of claims 1 and 2, wherein the electronics assembly (340) comprises a switch arranged to be activated by assembly of the electronics assembly (340) into the drug delivery device (100) such that the switch activates the electronics assembly (340).
  4. The electronics assembly (340) of any of claims 1 to 3, wherein the second frequency corresponds to a time interval that is less than one hour.
  5. The electronics assembly (340) of any of claims 1 to 3, wherein the first frequency corresponds to a time interval that is more than 12 hours and the first duration is less than 30 minutes.
  6. The electronics assembly (340) of any of claims 1 and 5, wherein the instructions stored on the at least one non transitory computer readable medium include: determining a remaining power level of the power module (346), and adjusting the first duration based on the remaining power level.
  7. The electronics assembly (340) of any of claims 1 and 5, wherein the instructions stored on the at least one non transitory computer readable medium include: storing each change in the fill level of the drug container in the memory, and when the wireless module (345) is paired, transmitting each of the stored changes in the fill level of the drug container to the external device (480) and deactivating the wireless module (345).
  8. The electronics assembly (340) of any of claims 1 to 7, wherein the sensor (341) is arranged to be disposed inside of a bung, and wherein the bung is configured to be inserted into the drug container.
  9. The electronics assembly (340) of any of claim 1 to 8, wherein the electronics assembly (340) is configured to be inserted into the bung.
  10. The electronics assembly (340) of any of claims 8 and 9, wherein the electronics assembly (340) and/or the sensor (341) is integrally formed with the bung.
  11. The electronics assembly (340) of any of claims 8 to 10, wherein the sensor (341) is configured to measure the fill level of the drug container by measuring a position of the bung in the drug container and wherein the instructions include calculating the fill level of the drug container based on the sensed position of the bung.
  12. The electronics assembly (340) of any of claims 1 to 10, wherein the sensor (341) comprises an ultrasonic transmitter and corresponding detector, the ultrasonic transmitter configured to emit an ultrasonic signal into the drug container, and the corresponding detector being configured to receive a reflection of the ultrasonic signal from the drug container and output the measurement signal to the processor.
  13. The electronics assembly (340) of any of claims 1 to 12, wherein the electronics device is selected from the following: a smart phone, a smart watch, a tablet, and a personal computer.
  14. The electronics assembly (340) of any of claims 1 to 13, wherein the drug delivery device (100) or the drug container comprises printed identification or expiration information, and wherein the instructions stored on the at least one non transitory computer readable medium include: when the wireless module (345) is paired, transmitting confirmation identification corresponding to the printed identification or expiration information.
  15. A system comprising: a drug delivery device (100) comprising a housing; a drug container configured to be contained in the housing of the drug delivery device; and a bung disposed in a cavity of the drug container and configured to be driven into the drug container by a drive mechanism of the drug delivery device, wherein the bung or the drug container comprises the electronics assembly (340) of claim 1.

Description

This description relates to an electronics assembly with wireless capabilities for use in a drug delivery device. A variety of diseases exist that require treatment by injection of a medicament. Such injections can be performed using drug delivery devices, which can be applied either by medical personnel or by patients themselves. As an example, type-1 and type-2 diabetes can be treated by patients themselves by injection of drug doses, for example once or several times per day. For instance, a pre-filled disposable drug pen or autoinjector can be used as a drug delivery device. Alternatively, a re-usable pen or autoinjector may be used. A re-usable pen or autoinjector allows replacement of an empty medicament cartridge by a new one. Either type of pen or autoinjector may come with a set of one-way needles that are replaced before each use. International application WO 2016/019375 A1 describes an apparatus for measuring medicament volume in a container. The apparatus includes light sources configured to emit electromagnetic radiation towards a medicament container and optical sensors optically coupled to the light sources for detecting electromagnetic radiation emitted by the light sources. The apparatus further includes a temperature sensor for measuring the temperature of liquid in the container. The apparatus also includes at least one processor to receive data from all of the sensors and convert the data into a signature representative of the EMR detected by the sensors. Thus, the apparatus of WO 2016/019375 can measure the quantity and/or temperature of a liquid disposed in a drug delivery device while accounting for the effects that temperature can have on the measuring of a quantity of liquid. International application WO 2017/189153 A1 describes a drug delivery device with a "smart" plunger head having sensors for calculate the quantity of medication in the drug delivery device. A transducer is disposed in the plunger head. The transducer is configured to measure a compressive force applied to the plunger head. The plunger head also includes a power source and a microcontroller disposed in the plunger head. The microcontroller is communicatively coupled to the power source and the transducer. The microcontroller is configured to enter a high-power mode in response to sensing application of the compressive force to the plunger head. Thus, in response to detecting a pressure being applied to the plunger head, the plunger head can switch from a low-power mode, where medicament detection is not occurring, to a high-power mode, where the plunger head's sensors are operating to sense the amount of medicament in the drug delivery device. This disclosure relates to drug delivery devices having electronics capable of detecting certain properties related to the drug delivery device, such as the fill level of medicament within a cartridge in the drug delivery device, and wirelessly transmitting those detected properties to an external device, such as a mobile phone, tablet, or computer, for a user to view. In certain cases, the electronics are housed within a bung or stopper of the cartridge. In a representative overview, an electronics assembly is inserted into the bung of the cartridge. The electronics assembly detects the fill level of the cartridge (e.g., by detecting a position of the bung), and, in some instances, the temperature of the cartridge or medicament therein. The fill level in the cartridge varies as the patient uses the device and the electronics assembly senses this change at a short time interval (e.g., 5 minutes) and this level change activates a Bluetooth transmitter at the moment the detection is sensed. Thereafter, the patient is able to pair or link an external device with the electronics assembly to activate a transmission of the measured data (e.g., the delivered dose). After a short time (e.g., 10 minutes), if no further change in the fill level in the cartridge has been measured and no external device has been paired, the Bluetooth transmitter can again be automatically set to sleep mode and the electronics assembly resumes sensing at regular intervals for the next drug delivery operation. After each detected injection, a new transfer of the device with the external device is possible. As an additional feature, a printed variable data (i.e., a batch or expiration date) or the material code of the label can be used when paired. These can either be read with a camera or can be entered manually by the patient in order to confirm that the data received from the electronics assembly matches the drug delivery device. In a representative example, an electronics assembly is arranged in a cartridge or otherwise positioned in a drug delivery device to enable a sensor of the electronics assembly to detect changes in the cartridge or a drive mechanism of the drug delivery device that is used for changing the fill level of the cartridge (e.g., a filling operation and a drug delivery operation).