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EP-4192550-B1 - DRUG DELIVERY DEVICE AND MODULE HEREWITH

EP4192550B1EP 4192550 B1EP4192550 B1EP 4192550B1EP-4192550-B1

Inventors

  • GAZELEY, Oliver, Charles
  • TOPOREK, MAURICE

Dates

Publication Date
20260506
Application Date
20210802

Claims (14)

  1. A drug delivery device, comprising a dose setting and driving assembly for dialing and dispensing a dose of a medicament from a cartridge of the drug delivery device, the dose setting and driving assembly comprising an outer housing (1, 11), a number sleeve (3) and a dose dial grip (4), wherein a portion of the number sleeve (3) is visible through an aperture or window (5) in the outer housing (1,11) to display the actually dialed dose, wherein the number sleeve (3) and the dose dial grip (4) are rotatable relative to the outer housing (1, 11) during dose dialing and wherein the number sleeve (3) is rotatable relative to the outer housing (1, 11) during dose dispensing, while the dose dial grip (4) is axially displaceable and rotationally constrained to the outer housing (1, 11) during dose dispensing, wherein the dose dial grip (4) comprises an outer skirt (6) partially protruding out of the outer housing (1, 11), characterized in that at least one of the number sleeve (3) and the skirt (6) of the dose dial grip (4) is provided with a series of circumferentially spaced conductive strips (12, 13, 14; 29) distributed around the outer circumference of the number sleeve (3) or the skirt (6) to provide at least two different pattern portions (110, 112, 114, 116) which are electrically separated, and that a series of contacts (164, 166, 168; 30) is arranged within the outer housing (1, 11) biased to abut the conductive strips, wherein the series of contacts (164, 166, 168; 30) is part of at least one bridging contact (15) in the drug delivery device configured and operable to selectively establish an electric connection between the at least two different pattern portions (110, 112, 114, 116) as number sleeve (3) and/or the skirt (6) is subject to a helical or rotational movement relative to the outer housing (1, 11), wherein the conductive strips (12, 13, 14; 29) and/or the contacts (15; 164, 166, 168; 30) are directly accessible from outside the outer housing (1, 11).
  2. The drug delivery device according to claim 1, wherein the series of contacts (164, 166, 168) form at least one reference element (15; 30), wherein the conductive strips (12, 13, 14; 29) form a pattern, and wherein the contacts and the conductive strips together form a detector arrangement comprising at least one electric sensor being operable to detect a positional variation of the pattern relative to the at least one reference element (15; 30) and to generate at least one electric signal in response to the positional variation of the pattern during at least one of the movements of the number sleeve (3) and/or the skirt (6) during dose dialing and dose dispensing relative to the outer housing (1, 11).
  3. The drug delivery device according to claim 2, wherein the pattern comprises at least a first pattern portion (110) that is electrically conductive and at least a second pattern portion (112) that is electrically insulating.
  4. The drug delivery device according to claim 3, wherein the contacts (164, 166, 168; 30) of the detector arrangement are operable to alternately connect to the first pattern portion (110) and the second pattern portion (112) of the pattern during at least one of the movements of the number sleeve (3) and/or the skirt (6) during dose dialing and dose dispensing relative to the outer housing (1, 11).
  5. The drug delivery device according to claim 3 or 4, wherein the pattern comprises at least a third pattern portion (114) that is electrically conductive, wherein the first pattern portion (110) and the third pattern portion (114) are electrically separated.
  6. The drug delivery device according to claim 5, wherein the detector arrangement and the at least one electric sensor are arranged on the outer circumference of the number sleeve (3) or the skirt (6), wherein the at least one electric sensor is electrically connected to the first pattern portion (110) and wherein the at least one reference element (15; 30) is arranged on the outer housing (1, 11) and comprises an electrical bridging contact (15) configured to alternately establish and interrupt an electric contact between the first pattern portion (110) and the third pattern portion (114) during at least one of the movements of the number sleeve (3) and/or the skirt (6) during dose dialing and dose dispensing relative to the outer housing (1, 11).
  7. The drug delivery device according to claim 6, wherein the electrical bridging contact (15) comprises a first electrical contact tap (164) and a second electrical contact tap (166), wherein the first electrical contact tap (164) and the second electrical contact tap (166) are electrically connected and wherein the first electrical contact tap (164) and the second electrical contact tap (166) are spatially separated from each other along a first separation direction (D1) parallel to a distance between the first pattern portion (110) and the third pattern portion (114).
  8. The drug delivery device according to claim 7, wherein the electrical bridging contact (15) comprises a third electrical contact tap (168) spatially separated from at least one of the first electrical contact tap (164) and the second electrical contact tap (166) along a second separation direction (D2) non-parallel to the first separation direction (D1).
  9. The drug delivery device according to any one of claims 6 to 8, wherein the electrical bridging contact (15) comprises a body made of sheet-metal and comprising at least one flexible arm, wherein at least one of the first electrical contact tap (164) and the second electrical contact tap (166) is arranged at a free end of the at least one flexible arm.
  10. The drug delivery device according to any one of the preceding claims, wherein the conductive strips (12, 13, 14) are printed on the skirt (6) of the dose dial grip (4).
  11. The drug delivery device according to any one of claims 1 to 9, wherein the conductive strips are provided on an encoder wheel (29) fixed to the number sleeve (3).
  12. The drug delivery device according to any one of the preceding claims, wherein the dose dial grip (4) comprises mechanical fixation means, e.g. clip features (23), and/or rotational alignment means (27) for attaching a separate module (20) on the dose dial grip (4).
  13. A module for detecting movement of at least one component part of a drug delivery device according to any one of the preceding claims, wherein the module (20) comprises - a microprocessor (21) for processing and/or storing data from a detector arrangement of the drug delivery device, - electrical connectors (22) to releasably establish contact with conductive strips (12, 13, 14) or contacts (30) of the drug delivery device, wherein the electrical connectors (22) comprise metal clips having a free end biased radially inwards for abutting the conductive strips (12, 13, 14) or contacts (30) of the drug delivery device, and - mechanical fixation means, e.g. clip features (23), and/or rotational alignment means (27) for attaching the module (20) on the dose dial grip (4) of the drug delivery device.
  14. The module according to claim 13, further comprising a cap (25, 26) to be, e.g. releasably, fitted over the dose dial grip (4) of the drug delivery device, wherein the cap (25, 26) comprises an outer profiled gripping surface and encloses the microprocessor (21) and the electrical connectors (22).

Description

The present invention is generally directed to a drug delivery device. The present invention further relates to a module, e.g. an add-on electronic device, to be used in conjunction with a drug delivery device. Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This may be increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their disease. In practice, such a drug delivery device allows a user to individually select and dispense a number of user variable doses of a medicament. There are basically two types of drug delivery devices: resettable devices (i.e., reusable) and non-resettable (i.e., disposable). For example, disposable pen delivery devices are supplied as self-contained devices. Such self-contained devices do not have removable pre-filled cartridges. Rather, the pre-filled cartridges may not be removed and replaced from these devices without destroying the device itself. Consequently, such disposable devices need not have a resettable dose setting mechanism. The present invention is generally applicable for disposable and reusable devices. However, the present invention is especially applicable in pre-filled, disposable pen type devices. Such drug delivery devices typically comprise dose setting and/or a drive mechanism to select an individual dose and to deliver this dose by displacing the piston in a cartridge containing a medicament. It is important for patients to be able to precisely select (dial) a desired dose prior to dispensing, thereby avoiding underdosage or overdosage which may result in severe health problems. For this purpose, it is known to provide a display on which the actually selected dose is indicated. In addition, a tactile or audible feedback may be generated, for example a click sound for each dose unit dialed. WO 2010/139636 A1 and EP 2 890 434 B1 each disclose such a drug delivery device having a display and a feedback mechanism comprising a detent or clicker which provides the user with an audible and tactile feedback as a dose is set. In addition to providing a feedback or indication relating to the currently selected dose to the patient, it is known to track and manage data relating to the type and/or amount of drug administered. For example, WO 2019/101962 A1, WO 2019/040117 A1 and WO 2020/127006 A each propose an electronic module to detect a movement of a component part of a drug delivery device which movement may be indicative for a state of the device or a quantity of a selected (dialed) or dispensed dose. These modules are integrated into the respective drug delivery device which raises the costs for manufacturing the devices. Thus, these modules are typically applicable in re-usable devices. WO 2014/111341 A1, WO 2014/111343 A1 and WO 2014/111335 A1 disclose similar electronic modules suitable for use wth a drug delivery device, wherein e.g. WO 2014/111341 A1 proposes a module detachable from the drug delivery device. In these devices, an electrically conductive track may be provided on a component part of the drug delivery device, e.g. on the number sleeve. In addition, it is known to use separate modules which may be clamped onto the drug delivery device and use contactless technologies to detect a movement of a component part of a drug delivery device. It is an object of the present invention to provide an improved drug delivery device allowing reliable and cost-effective detection of the selected dose. It is a further object to provide a module for use with such a drug delivery device. This object is solved for example by the subject matter defined in the independent claims. Advantageous embodiments and refinements are subject to the dependent claims. However, it should be noted that the disclosure is not restricted to the subject matter defined in the appended claims. Rather, the disclosure may comprise improvements in addition or as an alternative to the ones defined in the independent claims as will become apparent from the following description. An example of a drug delivery device comprises a dose setting and driving assembly for dialing and dispensing a dose of a medicament from a cartridge of the drug delivery device. Preferably, the dose setting and driving assembly comprises an outer housing, a number sleeve and a dose dial grip, wherein a portion of the number sleeve is visible through an aperture or window in the outer housing to display the actually dialed dose. The number sleeve and the dose dial grip may be rotatable relative to the outer housing during dose dialing and the number sleeve may be rotatable relative to the outer housing during dose dispensing, while the dose dial grip is axially displaceable and rotationally constrained to the outer housing during dose dispensing. The dose dial grip may comprise an outer skirt partially protruding out of the outer housing. Preferably, the outer skirt co