Drug delivery device with electronic system

Abstract

An electronic system for a drug delivery device is disclosed. The electronic system comprises a dose setting and drive mechanism. The dose setting and drive mechanism comprises a first member and a button module. The dose setting and drive mechanism is configured such that, at least in the dose delivery operation and/or in the dose setting operation, the first member moves relative to the button module. The electronic system has at least a first low power consumption state and a second high power consumption state. A rotation and/or axial movement of the button module relative to the first member generates a movement component of the at least one switch member relative to the button module and the first member, which triggers switching between the first low power consumption state and the second high power consumption state.

1 - 15 . (canceled) 
     
     
         16 . An electronic system for a drug delivery device, the electronic system comprising:
 a dose setting and drive mechanism configured to perform (i) a dose setting operation for setting a dose to be delivered by the drug delivery device and (ii) a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member; and   a button module comprising an electronic control unit connected to at least a rotary sensor, a communication unit, and a use detection unit, the communication unit being configured to communicate with another device, the use detection unit having multiple switches comprising a rotational switch and an axial switch,   wherein the electronic control unit is configured to control an operation of the electronic system, and has a distal surface facing towards the dose setting and drive mechanism,   wherein the button module and the dose setting and drive mechanism are configured such that
 the first member rotates relative to the button module during the dose delivery operation but does not rotate relative to the button module during the dose setting operation, and 
 the button module moves axially relative to the first member during a transition from the dose setting operation to the dose delivery operation, or when the button module is pressed in a dialled condition of a zero unit dose, 
   wherein the switches comprise at least four contact pads at the distal surface of the electronic control unit and at least two switch members each having at least two corresponding switch contacts defining
 a first electrical state when one of the switch contacts is not connected to a corresponding contact pad, and 
 a second electrical state when both contact pads of the respective switch members are connected to the corresponding switch contacts, 
   wherein a rotation of the first member relative to the button module generates a movement component of a switch member of the rotational switch relative to the button module and the first member, thereby switching between the first electrical state and the second electrical state which in turn triggers activation of the rotary sensor,   wherein an axial movement of the button module relative to the first member generates a movement component of a switch member of the axial switch relative to the button module and the first member, thereby switching between the first and the second electrical states which in turn activates the communication unit.   
     
     
         17 . The electronic system according to  claim 16 , wherein a least one of (i) the movement component generated as a result of the rotation of the first member relative to the button module or (ii) the movement component generated as a result of an axial movement of the button module relative to the first member is an axial movement relative to the button module and the first member. 
     
     
         18 . The electronic system according to  claim 16 , wherein the rotary sensor comprises at least one of a light source with a corresponding optical sensor, an electrical sliding contact, a mechanical switching arrangement, or a magnetic sensor. 
     
     
         19 . The electronic system according to  claim 16 , wherein each switch member comprises at least a respective first elastically deformable switch contact abutting or connected to one of the contact pads, and a respective second elastically deformable switch contact arranged axially offset to the respective first elastically deformable switch contact and spaced from one of the other contact pads. 
     
     
         20 . The electronic system according to  claim 16 , wherein the axial switch is operable by a relative axial displacement of the button module and the first member, wherein the axial switch comprises a switch chassis constraining a switch contact strip comprising elastically deformable switch contacts. 
     
     
         21 . The electronic system according to  claim 20 , wherein the switch contact strip is substantially U-shaped with two legs each forming one of the elastically deformable switch contacts, and wherein the switch contact strip is arranged such that the legs are axially offset to each other. 
     
     
         22 . The electronic system according to  claim 20 , wherein the switch chassis is interposed between a module chassis of the button module and the electronic control unit with an axially extending protrusion of the switch chassis extending towards the first member, such that when the button module moves axially towards the first member, one of the switch contacts is brought into abutment with one of the contact pads. 
     
     
         23 . The electronic system according to  claim 16 , wherein the rotational switch is operable by a relative rotation of the button module and the first member, wherein the rotational switch comprises a rocker constraining a switch contact pressing comprising elastically deformable switch contacts, wherein the rocker is pivotably guided in the button module. 
     
     
         24 . The electronic system according to  claim 23 , wherein the switch contact pressing comprises two contact arms, wherein tips of the two contact arms are axially offset to each other and form elastically deformable switch contacts. 
     
     
         25 . The electronic system according to  claim 23 , wherein the rocker is interposed between a module chassis of the button module and the electronic control unit with a radially extending protrusion of the rocker extending towards the first member, such that when the button module rotates relative to the first member a radial motion of the protrusion of the rocker results in an axial motion at the switch contacts, and results in one of the switch contacts to be brought into abutment with one of the contact pads. 
     
     
         26 . The electronic system according to  claim 16 , wherein the first member is a dial sleeve assembly or a member axially and/or rotationally locked thereto, wherein the first member is rotatable relative to a housing of the dose setting and drive mechanism at least in the dose setting operation, and wherein the button module is axially displaceable relative to the first member and rotationally constrained to the housing at least in the dose delivery operation. 
     
     
         27 . The electronic system according to  claim 26 , wherein the first member is rotatable relative to the housing of the does setting and drive mechanism along a helical path. 
     
     
         28 . The electronic system according to  claim 25 , wherein a switch chassis of the axial switch is interposed between a module chassis of the button module and the electronic control unit with an axially extending protrusion of the switch chassis extending towards the first member, such that when the button module moves axially towards the first member, one of the switch contacts is brought into abutment with one of the contact pads, and
 wherein the first member comprises
 an encoder ring having a radial ratchet profile for interaction with the radially extending protrusion of the rocker of the rotational switch, and 
 a proximally facing, ring-shaped running face for interaction with the axially extending protrusion of the switch chassis of the axial switch. 
   
     
     
         29 . The electronic system according to  claim 16 , wherein the rotary sensor is in a sleeping mode in a first low power consumption state and is configured to be activated to enter a second high power consumption state, with the electronic system being configured such that it is switched from the first low power consumption state into the second high power consumption state by the electronic control unit in response to a signal of the rotational switch, thereby inducing the rotary sensor to initiate a motion detection. 
     
     
         30 . The electronic system according to  claim 29 , wherein the electronic control unit is adapted to switch the rotary sensor into the first low power consumption state in response to a signal indicating that the axial switch is switched from a first electrical state of the axial switch to a second electrical state of the axial switch. 
     
     
         31 . The electronic system according to  claim 30 , wherein the first electrical state of the axial switch is an electrically open circuit state, and the second electrical state of the axial switch is an electrically closed circuit state of the axial switch. 
     
     
         32 . The electronic system according to  claim 29 , wherein the electronic control unit is adapted to generate a failure indicating signal when a difference in rotational positon is detected by the rotary sensor without detection of a state change of the rotational switch, or when a rotational switch state change is received with no corresponding axial switch state change. 
     
     
         33 . The electronic system according to  claim 16 , wherein the communication unit is in a sleeping mode in a first low power consumption state and is configured to be activated to enter a second high power consumption state. 
     
     
         34 . The electronic system according to  claim 33 , wherein the communication unit comprises a wireless communication interface for communicating with another device, with the electronic system being configured such that it is switched from the first low power consumption state into the second high power consumption state by the electronic control unit in response to a signal of the axial switch, thereby inducing the communication unit to initiate a manual synchronization and/or a pairing with another device. 
     
     
         35 . A drug delivery device comprising:
 a electronic system comprising
 a dose setting and drive mechanism configured to perform (i) a dose setting operation for setting a dose to be delivered by the drug delivery device and (ii) a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member; and 
 a button module comprising an electronic control unit connected to at least a rotary sensor, a communication unit, and a use detection unit, the communication unit being configured to communicate with another device, the use detection unit having multiple switches comprising a rotational switch and an axial switch, 
 wherein the electronic control unit is configured to control an operation of the electronic system, and has a distal surface facing towards the dose setting and drive mechanism, 
 wherein the button module and the dose setting and drive mechanism are configured such that
 the first member rotates relative to the button module during the dose delivery operation but does not rotate relative to the button module during the dose setting operation, and 
 the button module moves axially relative to the first member during a transition from the dose setting operation to the dose delivery operation, or when the button module is pressed in a dialled condition of zero unit dose, 
 
 wherein the switches comprise at least four contact pads at the distal surface of the electronic control unit and at least two switch members each having at least two corresponding switch contacts defining
 a first electrical state when one of the switch contacts is not connected to a corresponding contact pad, and 
 a second electrical state when both contact pads of the respective switch members are connected to the corresponding switch contacts, 
 
 wherein a rotation of the first member relative to the button module generates a movement component of a switch member of the rotational switch relative to the button module and the first member, thereby switching between the first and the second electrical states which in turn triggers activation of the rotary sensor, 
 wherein an axial movement of the button module relative to the first member generates a movement component of a switch member of the axial switch relative to the button module and the first member, thereby switching between the first and the second electrical states which in turn activates the communication unit; and 
   a container receptacle that is permanently or releasably connected to the dose setting and drive mechanism, and adapted to receive a container containing a medicament.