Search

EP-4647095-B1 - ELECTRONIC ADD-ON MODULE AND ASSEMBLY OF AN ELECTRONIC ADD-ON MODULE AND A DRUG DELIVERY DEVICE

EP4647095B1EP 4647095 B1EP4647095 B1EP 4647095B1EP-4647095-B1

Inventors

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

Dates

Publication Date
20260506
Application Date
20240510

Claims (17)

  1. An electronic add-on module configured for releasable attachment to a drug delivery device (100) which comprises a device housing (101) and a device dial grip (103), the electronic add-on module comprises at least - a body (1, 12, 24, 34, 47, 60) configured to be releasably attached to the device housing (101), - a coupler (3, 14, 26, 36, 49, 62) configured to be releasably attached to the device dial grip (103), and - a dial (4, 15, 27, 37, 50, 63) configured to be axially displaceable with respect to the coupler (3, 14, 26, 36, 49, 62), wherein an electric power source (80), a circuit board assembly (81) electrically connected to the electric power source, and a sensor arrangement (9, 23, 33, 45, 57, 72) electrically connected to the circuit board assembly are arranged in the dial (4, 15, 27, 37, 50, 63), characterized in that the electronic add-on module is configured to be switched between a dialing mode in which the dial (4, 15, 27, 37, 50, 63) is rotationally constrained to the coupler (3, 14, 26, 36, 49, 62) and a dispensing mode by means of an axial displacement of the dial (4, 15, 27, 37, 50, 63) relative to the body (1, 12, 24, 34, 47, 60), and wherein the electronic add-on module further comprises a tube (2, 13, 25, 35, 48, 61) which is configured to be permanently rotationally constrained to the body (1, 12, 24, 34, 47, 60) and configured to be axially displaceable relative to the body (1, 12, 24, 34, 47, 60) and in that the dial (4, 15, 27, 37, 50, 63) is configured to be rotatable relative to the tube (2, 13, 25, 35, 48, 61) at least in the dialing mode.
  2. The electronic add-on module according to claim 1, wherein the body (1, 12, 24, 34, 47, 60) and the tube (2, 13, 25, 35, 48, 61) each comprise mating splines (5, 8, 16, 17, 29, 52, 53, 66, 67) configured to permanently rotationally constrain the tube (2, 13, 25, 35, 48, 61) to the body (1, 12, 24, 34, 47, 60) and to permit axial displacement of the tube (2, 13, 25, 35, 48, 61) relative to the body (1, 12, 24, 34, 47, 60).
  3. The electronic add-on module according to any of the preceding claims, wherein the tube (2, 13, 25, 35, 48, 61) is axially constrained to the coupler (14, 26, 36, 49, 62) or to the dial (4, 15, 27, 37, 50, 63).
  4. The electronic add-on module according to any of the preceding claims, wherein the coupler (3, 14, 26, 36, 49, 62) is rotatable relative to the tube (2, 13, 25, 35, 48, 61).
  5. The electronic add-on module according to any of the preceding claims, wherein the sensor arrangement (9, 23, 33, 45, 57, 72) comprises at least one non-contact sensor.
  6. The electronic add-on module according to claim 5, wherein the non-contact sensor is at least one optical sensor (9, 23, 33, 45, 57, 72), wherein the coupler (3, 14, 26, 36, 49, 62) and/or the tube (2, 13, 25, 35, 48, 61) comprises regions of reflectivity (10, 11, 22, 43, 54, 68) and regions of absorption, and wherein the at least one optical sensor (9, 23, 33, 45, 57, 72) is configured and arranged to sense the regions of reflectivity (10, 11, 22, 43, 54, 68).
  7. The electronic add-on module according to any of the preceding claims, wherein at least a portion of the body (1, 12, 24, 34, 47, 60), the tube (2, 13, 25, 35, 48, 61) and/or the dial (4, 15, 27, 37, 50, 63) is optically transparent.
  8. The electronic add-on module according to any of the preceding claims, further comprising a first clutch (6, 7, 19, 21, 65, 70) for rotationally coupling and decoupling the coupler (3, 14, 26, 62) and the dial (4, 15, 27, 63), wherein the electronic add-on module is configured to be switched between the dialing mode in which the dial (4, 15, 27, 63) is rotationally constrained to the coupler (3, 14, 26, 62) and the dispensing mode in which the dial (4, 15, 27, 63) is rotationally decoupled from the coupler (3, 14, 26, 62).
  9. The electronic add-on module according to claim 8, wherein the electronic add-on module is configured to be switched from the dialing mode into the dispensing mode by means of a distal axial displacement of the dial (4, 15, 27, 63) towards the body (1, 12, 24, 34, 47, 60).
  10. The electronic add-on module according to any of the preceding claims, further comprising a second clutch (18, 20, 64, 69) for rotationally coupling and decoupling the tube (13, 61) and the dial (15, 63), wherein, in the dispensing mode of the electronic add-on module, the tube (13, 61) and the dial (15, 63) are rotationally constrained.
  11. The electronic add-on module according to any of the preceding claims, further comprising a separate button (28, 38, 51) arranged at the proximal end of the dial (27, 37, 50) and guided therein such that button (28, 38, 51) is rotatable with respect to the dial (27, 37, 50).
  12. The electronic add-on module according to any of claims 1 to 10, wherein the dial (4, 15, 63) is a combined dial button with a proximal actuation end face.
  13. The electronic add-on module according to any of the preceding claims, wherein the body (1, 12, 24, 34, 47, 60) comprises on its inner side at least one elastomeric grip and/or at least one mechanical clip configured to be releasably attached to the device housing (101).
  14. The electronic add-on module according to any of the preceding claims, wherein the coupler (3, 14, 26, 36, 49, 62) comprises on its inner side at least one elastomeric grip and/or at least one mechanical clip configured to be releasably attached to the device dial grip (103).
  15. The electronic add-on module according to any of the preceding claims, wherein the circuit board assembly (81) and the sensor arrangement (9, 23, 33, 45, 57, 72) are adapted and configured to detect or calculate a dose set by a user in the dialing mode, a dialing start point, a dialing end point, a dispensing start point, a dispensing end point and/or a dose amount ejected from the drug delivery device (100) in the dispensing mode.
  16. The electronic add-on module according to any of the preceding claims, further comprising a switch electrically connected to the electric power source (80) and/or the circuit board assembly (81), wherein the switch is configured to be operated when the electronic add-on module is switched from the dialing mode into the dispensing mode and/or when the drug delivery device is dialed.
  17. An assembly comprising a drug delivery device (100) and an electronic add-on module according to any one of the preceding claims, wherein the drug delivery device (100) comprises a device housing (101) and a device dial grip (103) which is rotatable relative to the device housing (101) for setting a dose, wherein the body (1, 12, 24, 34, 47, 60) of the electronic add-on module is releasably attached to the device housing (101), and wherein the coupler (3, 14, 26, 36, 49, 62) of the electronic add-on module is releasably attached to the device dial grip (103).

Description

The present disclosure is generally directed to an electronic add-on module and to an assembly of an electronic system, e.g. an electronic add-on module, which is configured to be releasably attached to a drug delivery device. A variety of diseases exists that require regular treatment by injection of a medicament. Such injection can be performed by using injection devices (drug delivery devices), which are 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 insulin doses, for example once or several times per day. For instance, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a re-usable pen may be used. A reusable pen allows replacement of an empty medicament cartridge by a new one. Some drug delivery devices only allow injection of a previously fixed dose (so-called fixed dose devices). In other devices (so-called variable dose devices) the medicament dose to be injected can be manually selected at the injection device by turning a dosage knob, often referred to as dial grip, and observing the actual dose from a dose window or display of the injection device. The dose is then injected by inserting the needle into a suited skin portion and pressing an injection button of the injection device. Known drug delivery devices are explained in more detail for example in EP 1 570 876 B1, EP 2 814 547B1, EP 2 890 434 B1, EP 3 164 173 A1, WO 2005/018721 A1, WO 2009/132777 A1, WO 2014/033195 A1, US 5,693,027 A, US 6,663,602 B2, US 7,241,278 B2 or US 9,937,294 B2. To be able to monitor medicament injection, for instance to prevent false handling of the insulin pen or to keep track of the doses already applied, it is desirable to measure information related to a condition and/or use of the injection device, such as for instance information on the injected medicament dose. For example electronic add-on modules are known which measure relevant data with respect to dose setting and/or dose dispensing. An exemplary data collection device for attachment to an injection device is for example shown in WO 2016/198516 A1. This data collection device is configured as a cap which can be attached onto a dial grip of a drug delivery device. The device of WO 2016/198516 A1 is applicable to drug delivery devices providing a sufficient rotational reference to the stationary components of the drug delivery device. However, some known drug delivery devices do not have relatively rotating components easily accessible to the module. Without this rotational reference the dose recording of the electronic module might be susceptible to errors caused by rotations induced by the user when dispensing. Another add-on module is known from WO 2021/260404 A1. This module comprises a portion which is fixed to the stationary outer housing of the drug delivery device and another portion which is fixed to the rotatable dial grip of the drug delivery device. The module comprises a magnetic field production means and a plurality of magnetic sensors and is configured to calculate and determine whether or not all of the dose or amount set by the user of the drug delivery device has been ejected from the drug delivery device. This module can only be used with a drug delivery device having an axially stationary dial grip, i.e. without a so-called dial extension during dose dialing. Other add-on modules are known from WO 2023/169924 A1, WO 2019/162235 A1, US 2023/347066 A1 and US 11 554 221 B2. Further, using the detection of relative movements often requires further, especially structural, modifications to the drug delivery device as movements of components inside the drug delivery device may best to be sensed in order to gather relevant dose event information. These structural modifications, for example the provision of encoder patterns, are less suitable for retrofitting a drug delivery device with an electronic add-on module. Consequently, there is a need to provide an electronic add-on module which may be used with a variety of different drug delivery devices without requiring structural modifications of the drug delivery devices. In addition, it is an object of the present invention to provide an improved electronic add-on module that is configured to detect dose events of different drug delivery devices in a reliable and safe manner. This object is solved by an electronic add-on module according to claim 1 as well as by an assembly according to claim 17. An electronic add-on module according to the present disclosure is configured for releasable attachment to an, e.g. pen injector type, drug delivery device, especially to a device housing and a device dial grip. The electronic add-on module may comprise at least a body configured to be releasably attached to the device housing, a coupler configured to be releasably attached to the device dial grip, and a dial configured to be axially displaceable with respect