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EP-4072618-B1 - DRUG DELIVERY DEVICE, SYSTEM COMPRISING A DRUG DELIVERY DEVICE, AND ASSOCIATED METHOD

EP4072618B1EP 4072618 B1EP4072618 B1EP 4072618B1EP-4072618-B1

Inventors

  • BLANCKE, STEFAN
  • JUGL, MICHAEL

Dates

Publication Date
20260513
Application Date
20201208

Claims (14)

  1. A drug delivery device (100), the drug delivery device comprising: - a thermal coupling surface (130) which is arranged and configured to transfer thermal energy, - a thermally controlled member (150), which is thermally conductively connected to the thermal coupling surface, wherein the thermally controlled member (150) is configured to operate in response to thermal energy transferred through the thermal coupling surface (130), and wherein the drug delivery device (100) is configured to perform a drug delivery operation, wherein the thermally controlled member (150) is arranged and configured to move in response to thermal energy transferred through the thermal coupling surface (130), wherein the movement is used for the operation of the drug delivery device; wherein the drug delivery device (100) comprises an activation surface (124), wherein the activation surface is arranged to be contacted by a user to initiate the drug delivery operation of the drug delivery device, and wherein the thermal coupling surface (130) is accessible on the activation surface; and wherein regions laterally surrounding or adjacent to the thermal coupling surface are formed of a material having lower thermal conductivity than the thermal coupling surface.
  2. The drug delivery device of claim 1 wherein the thermally controlled member (150) is an electrical, preferably electronic, temperature sensor or an electrical, preferably electronic, temperature triggerable switch.
  3. The drug delivery device of any one of the preceding claims, wherein the thermally controlled member (150) is a bimetallic member.
  4. The drug delivery device of any one of the preceding claims, wherein the thermally controlled member (150) is designed to operate at a temperature greater than or equal to one of the following values: 22 °C, 23 °C, 24 °C, 25 °C, 26 °C, 27 °C, 28 °C, 29 °C, 30 °C, 31 °C, 32 °C, 33 °C, 34 °C.
  5. The drug delivery device of any one of the preceding claims, wherein the thermally controlled member (150) is designed to operate at a temperature less than or equal to one of the following values: 44 °C, 43 °C, 42 °C, 41 °C, 40 °C, 39 °C, 38 °C, 37 °C, 36 °C, 35 °C, 34 °C, 33 °C, 32 °C, 31 °C, 30 °C, 29 °C.
  6. The drug delivery device of any one of the preceding claims, wherein the drug delivery device (100) comprises a housing (110) and a receptacle (114), which is provided in the housing or permanently or releasably connected to the housing, wherein the receptacle is designed to receive a medicament container (160) or wherein the medicament container is received in the receptacle, and wherein the drug delivery device comprises a drive mechanism, which is operable to drive the drug delivery operation, wherein the drive mechanism comprises at least one moveable drive member (190) which is configured to be moved with respect to the housing in order to deliver medicament from the medicament container through a dispensing opening of the drug delivery device during the drug delivery operation.
  7. The drug delivery device of claim 6, wherein the thermal coupling surface (130) is associated with the receptacle of the drug delivery device (100) such that the thermal coupling surface is thermally conductively connected to the medicament container, when the medicament container is arranged in the receptacle.
  8. The drug delivery device of any one of the preceding claims, wherein the drug delivery device (100) is configured such that in response to thermal energy supplied to the thermal coupling surface (130) a mechanical lock is released, wherein the mechanical lock, when established, prevents movement of an element of the device and, when the mechanical lock is released, the movement of the element is allowed.
  9. The drug delivery device of claim 8, wherein the element is a trigger member for initiation of the drug delivery operation, and wherein the trigger member is a trigger button or a needle shroud.
  10. The drug delivery device of any one of the preceding claims, wherein the drug delivery device comprises a bearing surface (116), which is arranged to contact the skin of a user or patient during and/or before the drug delivery operation, wherein the thermal coupling surface (130) is accessible on the bearing surface.
  11. The drug delivery device of any one of the preceding claims, wherein the drug delivery device (100) comprises an electronic control unit (200), wherein the thermally controlled member (150) is operatively coupled or coupleable to the electronic control unit and wherein the drug delivery device is configured such that the electronic control unit permits initiation of the drug delivery operation only if a temperature at the thermal coupling surface (130) is within a predetermined temperature range.
  12. The drug delivery device of any one of the preceding claims, wherein the drug delivery device (100) is configured to store and/or transmit data on the temperature at the thermal coupling surface, in particular when the drug delivery operation has been initiated and/or while the drug delivery operation is being performed.
  13. A system comprising the drug delivery device (100) of any one of the preceding claims and an evaluation unit (500) which is integrated into or operatively coupleable to the drug delivery device, wherein the drug delivery device is configured to transfer temperature data which is indicative for the temperature at the thermal coupling surface, in particular during a delivery operation, to the evaluation unit.
  14. A method for evaluating a drug delivery device (100) according to any one of the preceding claims 1 to 12, comprising the step of comparing a temperature at the thermal coupling surface (130) with a predetermined temperature or temperature range, the temperature being preferably derived from the thermally controlled member, e.g. before, during or after the delivery operation.

Description

Background The present disclosure relates to a drug delivery device, a system with a drug delivery device, and a method relating to a drug delivery device, e.g. a method for evaluating a drug delivery device, in particular an operation of the drug delivery device. Drug delivery devices are usually used by users such as patients and/or caregivers or other medically trained or untrained people to administer drugs from a drug container into a body such as a human body. Examples of such drug delivery devices can be found in WO 2016/041872 A1, WO 2008/105958 A2, WO 2017/090019 A2, WO 2016/120207 A1 and GB 2 490 721 A. It is an object of the present disclosure to provide improvements relating to drug delivery devices and/or their operation. This object is achieved by the subject-matter of the independent claims. Advantageous embodiments and refinements may be subject to dependent claims or are contained elsewhere in the disclosure. Also, the present disclosure may contain subject-matter which relates to improvements of drug delivery devices but is not claimed be it dependently or independently. Summary The invention is defined in claims 1 and 14. Advantageous embodiments are subject of the dependent claims. According to one aspect, the present disclosure relates to a drug delivery device. The drug delivery device may be configured to perform a drug delivery operation, in particular when actuated or initiated by a user. According to another aspect, the present disclosure relates to a system comprising the drug delivery device. According to yet another aspect, the present disclosure relates to a method. The method may be a method for evaluating or influencing a drug delivery device, in particular an operation of the drug delivery device such as a delivery operation. The device evaluated in the method is preferably the disclosed drug delivery device. It should be understood that features which are disclosed in relation to different aspects or embodiments do also apply for other aspects or embodiments. For example, features which are disclosed for the drug delivery device do also apply for the system and the method and vice versa. Also, features disclosed in conjunction with different embodiments can be combined with one another. In an embodiment, the drug delivery device comprises a thermal coupling surface. The thermal coupling surface may be arranged and/or configured to transfer, e.g. to receive and/or emit, thermal energy, e.g. heat. The thermal coupling surface may be configured to be coupled thermally to another element. The thermal coupling surface may be formed by a thermally conductive material, e.g. a metal or metal alloy. Regions laterally surrounding or adjacent to the thermal coupling surface are formed of a material having lower thermal conductivity. Typically, plastics have lower thermal conductivity than metals. For the energy transfer, the thermal coupling surface may be brought into thermal conductive connection, e.g. into mechanical contact, with the surface of another element with which the energy transfer should take place, e.g. the skin of the subject which should receive the drug to be delivered with the device. The drug delivery device may be configured such that thermal energy , e.g. heat, is guided away from the thermal coupling surface after it has been received by the thermal coupling surface. In an embodiment, the drug delivery device comprises a thermally controlled or operated member. The thermally controlled member may change its state in response to thermal energy provided to it. The thermally controlled member may be thermally conductively connected to the thermal coupling surface. The thermally controlled member may be configured to operate in response to the thermal energy transferred through the thermal coupling surface. Accordingly, thermal energy may be used within the drug delivery device such as to monitor an operation of the device, evaluate an operation of the device, control an operation of the device, and/or influence an operation of the device. The operation may be the drug delivery operation. In an embodiment, the thermally controlled member is a thermal energy conversion member. The thermal energy conversion member may be arranged and/or configured to convert thermal energy into non-thermal energy, in particular thermal energy transferred through the thermal coupling surface, e.g. to the thermal energy conversion member. In the device the converted non-thermal energy may be used to evaluate, monitor and/or influence the operation of the drug delivery device. In an embodiment, the thermal energy is supplied to the thermally controlled member through the thermal coupling surface. The thermal coupling surface may, therefore, act as an energy input surface. In an embodiment, the non-thermal energy is electrical energy or mechanical energy, e.g. kinetic energy. In an embodiment, the non-thermal energy is kinetic energy for moving or potential energy which is convertable int