Injection device and method of unlocking operation of the injection device

Patent metadata

Field	Value
Publication number	US-2025032724-A1
Application number	US-202218706854-A
Country	US
Kind code	A1
Filing date	Nov 1, 2022
Priority date	Nov 3, 2021
Publication date	Jan 30, 2025
Grant date	—

Abstract

The present disclosure relates to a method of unlocking operation of an injection device. The injection device includes a housing configured to accommodate a medicament container, and a drive mechanism operably engageable with the medicament container for expelling or withdrawing a dose of medicament from the medicament container. The drive mechanism includes at least one interlock configured to disable at least one of setting of the dose and dispensing of the dose. The injection device further includes an identifier provided on or associated with the medicament container, and an electronic unit operable to control the at least one interlock. The electronic unit includes a NFC (NFC) interface for obtaining information indicative of the identifier. The electronic unit is configured to process signals of the NFC interface to at least temporarily deactivate the at least one interlock.

First claim

1 - 19 . (canceled)

20 . An injection device for injecting of a dose of a medicament, the injection device comprising:
a housing configured to accommodate a medicament container, a drive mechanism operably engageable with the medicament container for expelling or withdrawing the dose of the medicament from the medicament container, wherein the drive mechanism comprises at least one interlock configured to disable at least one of setting of the dose or dispensing of the dose, an identifier provided on or associated with the medicament container, an electronic unit operable to control the at least one interlock and comprising a near-field communication interface for obtaining information indicative of the identifier, wherein the electronic unit is configured to process signals of the near-field communication interface to at least temporarily deactivate the at least one interlock.

21 . The injection device according to claim 20 , wherein the housing comprises a distal housing component and a proximal housing component, wherein the distal housing component is configured to accommodate the medicament container and the proximal housing component is configured to accommodate or to support the drive mechanism.

22 . The injection device according to claim 21 , wherein the identifier is located on or inside the distal housing component and the electronic unit is provided in or on the proximal housing component.

23 . The injection device according to claim 20 , wherein the identifier comprises a passive electronic identifier.

24 . The injection device according to claim 23 , wherein the passive electronic identifier comprises a near-field communication (NFC) tag configured to communicate with the near-field communication interface of the electronic unit.

25 . The injection device according to claim 20 , wherein the electronic identifier comprises a non-volatile memory to store at least one of a medicament name, a medicament manufacturing date, a medicament expiry date, a lot number of the medicament, and a unique medicament container ID.

26 . The injection device according to claim 25 , wherein the non-volatile memory is erasable and/or writable by the near-field communication interface.

27 . The injection device according to claim 20 , wherein the interlock remains activated and use of the injection device is impeded or blocked when the identifier does not match with the drive mechanism and/or when the information obtained by the near-field communication interface does not match with predefined medicament container-related data.

28 . The injection device according to claim 20 , wherein a transmission range of the near-field communication interface is smaller than a spatial distance between the near-field communication interface and the identifier when the medicament container is operably engaged with the drive mechanism.

29 . The injection device according to claim 20 , wherein the electronic unit further comprises a short-range communication interface to communicate with a corresponding short-range communication interface of an external electronic device.

30 . The injection device according to claim 29 , wherein the transmission range of the near-field communication interface is smaller than a transmission range of the short-range communication interface.

31 . The injection device according to claim 29 , wherein the short-range communication interface comprises a wireless communication interface based on one of the following communication standards: Bluetooth, Bluetooth low energy (BLE), Zigbee or Wi-Fi.

32 . The injection device according to claim 20 , wherein the electronic unit comprises at least one processor operable to process data or information of the identifier captured or read out by the electronic unit.

33 . The injection device according to claim 20 , wherein:
the at least one interlock comprises an electromechanical interlock configured to mechanically engage with a first component of the injection device and with a second component of the injection device, the first component is movable relative to the second component for at least one of setting of the dose and injecting of the dose, and the at least one interlock is operable to switch between an interlocked state in which the first component is fixed relative to the second component and a release state in which the first component is movable relative to the second component.

34 . The injection device according to claim 20 , wherein:
the drive mechanism comprises at least one clutch operable to switch the drive mechanism between a dose setting mode and a dose injecting mode, and the at least one interlock is operably engaged with the at least one clutch to selectively disable switching of the drive mechanism from one of the dose setting mode and the dose injecting mode into the other one of the dose setting mode and the dose injecting mode.

35 . The injection device according to claim 20 , wherein the medicament container filled with the medicament is arranged inside the housing.

36 . A method of unlocking operation of an injection device for at least one of setting or injecting of a dose of a medicament, wherein:
the injection device comprises a housing configured to accommodate a medicament container and a drive mechanism operably engageable with the medicament container for expelling or withdrawing the dose of the medicament from the medicament container, and the drive mechanism comprises at least one interlock configured to disable at least one of setting of the dose or dispensing of the dose, the method comprising:
capturing or reading an identifier provided on or associated with the medicament container by a near-field communication interface of an electronic unit of the injection device,
validating the identifier by comparing medicament-related data obtained from the identifier with predefined data related to the injection device, and
temporarily deactivating or re-activating the at least one interlock on the basis of the validation of the identifier.

37 . The method according to claim 36 , wherein for capturing or reading the identifier, the medicament container is at least temporarily arranged or brought within a transmission range of the near-field communication interface.

38 . The method according to claim 36 , wherein the electronic unit is configured to process signals of the near-field communication interface to at least temporarily deactivate the at least one interlock.

39 . A computer-readable medium comprising instructions that, when executed by an electronic unit of an injection device, cause the electronic unit to execute the steps of:
capturing or reading an identifier provided on or associated with a medicament container of the injection device by a near-field communication interface of the electronic unit of the injection device, validating the identifier by comparing medicament-related data obtained from the identifier with predefined data related to the injection device, and at least one of temporarily deactivating or re-activating the at least one interlock on the basis of the validation of the identifier.

Assignees

• Sanofi Sa

Inventors

• Alt Stefan
• Helmer Michael
• Schabbach Michael
• Vitt Martin

Classifications

• A61M5/31571

  Means preventing accidental administration (for automatic syringes A61M5/20) · CPC title

• A61M5/31546 Primary

  Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons · CPC title

• A61M2205/6009

  for matching patient with his treatment, e.g. to improve transfusion security · CPC title

• A61M2205/6063

  Optical identification systems · CPC title

• A61M2205/6054

  Magnetic identification systems · CPC title