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EP-4623956-B1 - ATTACHMENT MECHANISM, MODULE AND ASSEMBLY HEREWITH

EP4623956B1EP 4623956 B1EP4623956 B1EP 4623956B1EP-4623956-B1

Inventors

  • DRAPER, PAUL RICHARD
  • O'HARE, AIDAN MICHAEL
  • VEASEY, ROBERT FREDERICK
  • WALLACE, ANDREW

Dates

Publication Date
20260513
Application Date
20240328

Claims (11)

  1. An electronic add-on module (100) configured to be releasable attached to a drug delivery device (1), wherein the electronic add-on module (100) comprises at least one attachment mechanism configured for releasable attachment to a portion (11) of the drug delivery device (1), the module further comprising a main housing (101) with a distal attachment surface and a proximal actuation surface (108), wherein the proximal actuation surface (108) defines an auxiliary injection user interface configured to apply pressure onto an injection user interface (11) of the drug delivery device, wherein the main housing (101) encases an electrical power source (109) comprising a rechargeable battery, characterized in that the attachment mechanism comprises at least one attachment member (102) with a longitudinal axis (X), a distal end surface (103) forming the distal attachment surface of the module and an opposite proximal end surface (104), wherein the distal end surface (103) is an adhesive surface and that the proximal end surface (104) is an adhesive surface, and in that the proximal actuation surface (108) comprises electrodes (110) forming a capacitive switch, wherein the electrodes (110) of the proximal actuation surface (108) form connectors for charging the rechargeable battery.
  2. The electronic add-on module (100) according to claim 1, wherein the attachment member (102) is a self-adhesive tape or a or double-sided adhesive tape.
  3. The electronic add-on module (100) according to claim 1 or 2, wherein the proximal end surface (104) has a lower adhesion force than the distal end surface (103).
  4. The electronic add-on module (100) according to any of the preceding claims, wherein the proximal end surface (104) has a peel adhesion which is at least 10%, preferably 25%, lower than the peel adhesion of the distal end surface (103).
  5. The electronic add-on module (100) according to claim 4, wherein the proximal end surface (104) has a peel adhesion of 2 N/cm to 10 N/cm, preferably about 5 N/cm.
  6. The electronic add-on module (100) according to any of the preceding claims, wherein the main housing (101) encases a printed circuit board assembly (105), a sensor (106) arrangement, for example an acoustic sensor arrangement, configured to detect a relative movement between at least two component parts of the drug delivery device (1), a communication unit for communicating with another device, and/or a switch arrangement (107, 110).
  7. The electronic add-on module (100) according to any of the preceding claims, wherein the proximal actuation surface (108) is an elastically deformable surface with a snap dome type switch (107) positioned beneath the proximal actuation surface (108).
  8. The electronic add-on module (100) according to any of the preceding claims, wherein the sensor (106) arrangement comprises at least one microphone connected to the printed circuit board assembly (105).
  9. The electronic add-on module (100) according to any of the preceding claims, wherein the sensor (106) arrangement is configured to detect click sounds generated by a relative rotational movement between at least two component parts of the drug delivery device (1), and wherein the electronic module (100) is configured to determine an amount of dose selected and/or dispensed on the basis of the click sounds detected by the sensor (106) arrangement.
  10. An assembly comprising a drug delivery device and an electronic add-on module (100) according to any one of the preceding claims configured for attachment to the drug delivery device, wherein the drug delivery device comprises: • a device housing (10) with a container (14) configured to receive a drug or a cartridge filled with a drug, • a dose setting unit comprising a dose dial user interface (12) at least rotationally moveable with respect to the device housing (10) during dose setting and an injection user interface (11) at least axially moveable with respect to the device housing (10) for causing dose dispensing, and • a dose delivery unit comprising a plunger at least axially moveable with respect to the device housing (10) during dose dispensing, characterized in that the electronic add-on module (100) is releasably attached to the drug delivery device (1) by means of the attachment mechanism.
  11. The assembly according to claim 10, wherein the drug delivery device (1) further comprises a clicker mechanism generating an acoustic feedback signal at least during dose setting or dose dispensing.

Description

The present disclosure is generally directed to an attachment mechanism suitable for attaching for example a module to an object which may have an essentially circular or annular end surface, e.g. to a portion of a drug delivery device. Further, the disclosure is directed to an electronic system, e.g. an electronic add-on module, which is configured to be, e.g. releasably, attached to a drug delivery device as well as an assembly comprising the electronic add-on module as well as the drug delivery device. Electronic add-on modules may be used attached on to a drug delivery device, e.g. a pen-type injection device. Such drug delivery devices often comprise a housing with a container configured to receive a drug or a cartridge filled with a drug, a dose setting unit comprising a dose dial user interface, e.g. a dial grip, at least rotationally moveable with respect to the housing during dose setting and an injection user interface, e.g. a dose button, at least axially moveable with respect to the housing for causing dose dispensing, and a dose delivery unit comprising a plunger at least axially moveable with respect to the housing during dose dispensing. Electronic add-on modules for releasable attachment to drug delivery devices are generally known and often used to measure relevant data with respect to dose setting and/or dose dispensing. Due to the different dimensions and working principles of known injection devices, especially regarding dose dial user interfaces and injection user interfaces, such add-on modules are typically tailored to fit to one specific drug delivery device. This requires providing different modules for different devices. An electronic add-on module is known from WO 2016/198516 A1 which comprises a sleeve-like portion to be positioned over a dosage knob or dial grip of an injection device. A resilient padding is provided on the inner surface of the sleeve-like portion. The padding deforms to accommodate the dosage knob within the cavity of the sleeve-like portion. Further, a monitoring device for attachment to an injection device is known from US 2023/248906 A1 or WO 2019/145415 A1. The latter add-on device comprises a coupling element adapted for accommodating the push button and the selector of an insulin pen. In order to adapt to the specific form of any dose selector, the coupling element comprises a gasket with an inner orifice, whose inner surface is similar to the external surface of the selector, such that it can slide along it and embrace it achieving a firm attachment thereto. By employing different designs for the gasket, the device can be used with any available model of drug pen. The gasket is a removable element which can be detached from the coupling element for example, to be interchanged with other gaskets for the adaptation of the device for its coupling to different models of drug pens. A double-sided adhesive sticker for posters is known from EP 0 118 250 A2. It is an object of the present disclosure to provide an improved attachment mechanism, an improved electronic add-on module suitable to be used with various different drug delivery devices and an improved assembly comprising a drug delivery device and such an electronic add-on module. This object is essentially solved by an electronic add-on module according to claim 1 and an assembly according to claim 10. In the field of dose recording modules for injection devices it is advantageous to attach the module on the proximal end of the injection device so that the small cylindrical form is maintained, which is important for comfortable use of the device. This means it is advantageous to attach the module to either the dose dial grip of the injection device or the dose button. If the module is attached to the dose dial grip then this does have the downside of adding diametric size to the assembly, and furthermore in many injection devices the dose dial grip rotates during dosing and therefore the users hand needs to be clear of that part of the module to prevent blocking. Therefore, it is advantageous to attach a module to the dose button of the device. However, for most injection devices the dose button does not have suitable features to form a purely mechanical attachment. Therefore the present disclosure provides an attachment mechanism suitable to attach a module to the dose button of a drug delivery device. An attachment mechanism suitable for attaching a module to an object that may have an essentially circular or annular end surface, like an, e.g. cylindrical, drug delivery device or a portion thereof, may comprise at least one attachment member with a longitudinal axis, a distal end surface and an opposite proximal end surface. Attachment of a module or the like to a drug delivery device or the like may be effected by means of the distal end surface being an adhesive surface and the proximal end surface being an adhesive surface, for example a peelable adhesive surface. The attachment member may have a s