Pen-type drug injection device with controller and time lock-out mechanism for its drive

1. A drive mechanism for a drug delivery device, comprising:

a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction during a dose dispensing action,

at least one actuation member mechanically coupled with the piston rod to induce a distally directed displacement of the piston rod when actuated by a user, wherein the at least one actuation member comprises a stop element extending radially from the at least one actuation member,

an electronic control module integrated into the drive mechanism to ascertain at least one predefined condition of use and to store and to record subsequent actuation procedures or actuation instants of the drive mechanism, and

at least one interlock member coupled with and displaceable by the electronic control module to mechanically obstruct displacement of the piston rod if the condition of use is not fulfilled, wherein the at least one interlock member comprises a locking sleeve,

wherein the electronic control module is configured to impede displacement of the at least one actuation member by modifying an axial distance between the locking sleeve and the stop element.

2. The drive mechanism according to claim 1 , wherein the interlock member is adapted to releasably engage with any one of the piston rod, a drive member, the actuation member or with any other component mechanically engaged therewith.

3. The drive mechanism according to claim 1 , wherein the electronic control module is adapted to monitor and/or to verify a user-driven actuation of the drive mechanism.

4. The drive mechanism according to claim 1 , wherein the electronic control module is adapted to verify whether actuation of the drive mechanism matches with the at least one predefined condition of use.

5. The drive mechanism according to claim 1 , wherein the electronic control module communicates with at least any one of:

a pressure sensor coupled with the piston rod,

an authorization and/or communication module,

a chemical analysis module to determine usability of a medicament contained in the cartridge,

a skin touch sensor to register contact with the skin of a patient,

a timer circuit,

an electromechanical vibration module, and

at least one visual, audible and/or tactile indicator.

6. The drive mechanism according to claim 1 , wherein the electronic control module is configured to transfer the interlock member into a release mode only when the at least one condition of use is fulfilled.

7. The drive mechanism according to claim 1 , wherein the interlock member is adapted to releasably obstruct a user-initiated dose setting and/or a dose dispensing actuation if the condition of use is not fulfilled.

8. The drive mechanism according to claim 1 , wherein the electronic control module is capable to trigger a visual, an audible and/or a tactile indication that actuation of the device is due.

9. The drive mechanism according to claim 1 , wherein the electronic control module is capable to visually, audibly and/or tactilely instruct a user to correctly operate the drive mechanism.

10. The drive mechanism according to claim 1 , further comprising an electrically operated drive engaged with the locking sleeve and configured for axial displacement of the locking sleeve, wherein the electrically operated drive is controlled by the electronic control module.

11. A drug delivery device to set and to dispense a dose of a medicament and comprising:

a cartridge holder to receive a cartridge filled with a medicament,

a housing to accommodate a drive mechanism being operably connected with the cartridge holder, and

the drive mechanism comprising:

a piston rod to operably engage with a piston of the cartridge to displace the piston in a distal direction during a dose dispensing action,

at least one actuation member mechanically coupled with the piston rod to induce a distally directed displacement of the piston rod when actuated by a user, wherein the at least one actuation member comprises a stop element extending radially from the at least one actuation member,

an electronic control module integrated into the drive mechanism to ascertain at least one predefined condition of use and to store and to record subsequent actuation procedures or actuation instants of the drive mechanism, and

at least one interlock member coupled with and displaceable by the electronic control module to mechanically obstruct displacement of the piston rod if the condition of use is not fulfilled, wherein the at least one interlock member comprises a locking sleeve,

wherein the electronic control module is configured to impede displacement of the at least one actuation member by modifying an axial distance between the locking sleeve and the stop element.

12. The drug delivery device according to claim 11 , comprising a cartridge disposed in the cartridge holder being at least partially filled by the medicament.

13. The drug delivery device according to claim 11 , wherein the housing and/or the cartridge holder comprise a visual, audible and/or tactile indicator to indicate to the user whether a condition of use is actually fulfilled.

14. The drug delivery device according to claim 11 , further comprising an electrically operated drive engaged with the locking sleeve and configured for axial displacement of the locking sleeve, wherein the electrically operated drive is controlled by the electronic control module.

15. A method of operating a drug delivery device comprising a cartridge filled with a medicament and comprising a drive mechanism, wherein the method of operating comprises the steps of:

monitoring a dose setting and/or dose dispensing actuation of the drive mechanism by means of an electronic control module,

storing and recording subsequent actuation procedures or actuation instants of the drive mechanism,

determining at least one actual state parameter of the drug delivery device and comparing the state parameter with at least one predefined condition of use of the drug delivery device, and

mechanically obstructing or releasing actuation of the drive mechanism in response to the comparison of the state parameter and the at least one predefined condition of use, wherein mechanically obstructing or releasing actuation of the drive mechanism comprises modifying, by the electronic control module, an axial distance between a stop element of the drive mechanism and a locking sleeve of the drive mechanism.

16. A drive mechanism for a drug delivery device, comprising:

a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction during a dose dispensing action, wherein the piston rod comprises an outer thread,

at least one actuation member mechanically coupled with the piston rod to induce a distally directed displacement of the piston rod when actuated by a user,

an electronic control module integrated into the drive mechanism to ascertain at least one predefined condition of use and to store and to record subsequent actuation procedures or actuation instants of the drive mechanism, and

at least one interlock member coupled with the electronic control module to mechanically obstruct displacement of the piston rod if the condition of use is not fulfilled,

wherein the interlock member comprises a radially extending protrusion to engage with the outer thread,

wherein the interlock member is pivot mounted with regard to a pivot axis extending substantially parallel to the extent of the piston rod,

wherein the electronic control module is configured to pivot the interlock member between a release configuration and an interlock configuration, and

wherein, in the interlock configuration, the interlock member is engaged with the outer thread of the piston rod and impedes axial displacement of the piston rod.

17. A drug delivery device to set and to dispense a dose of a medicament and comprising:

a cartridge holder to receive a cartridge filled with a medicament,

a housing to accommodate a drive mechanism being operably connected with the cartridge holder, and

the drive mechanism comprising:

a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction during a dose dispensing action, wherein the piston rod comprises an outer thread,

at least one actuation member mechanically coupled with the piston rod to induce a distally directed displacement of the piston rod when actuated by a user,

an electronic control module integrated into the drive mechanism to ascertain at least one predefined condition of use and to store and to record subsequent actuation procedures or actuation instants of the drive mechanism, and

at least one interlock member coupled with the electronic control module to mechanically obstruct displacement of the piston rod if the condition of use is not fulfilled,

wherein the interlock member comprises a radially extending protrusion to engage with the outer thread,

wherein the interlock member is pivot mounted with regard to a pivot axis extending substantially parallel to the extent of the piston rod,

wherein the electronic control module is configured to pivot the interlock member between a release configuration and an interlock configuration, and

wherein, in the interlock configuration, the interlock member is engaged with the outer thread of the piston rod and impedes axial displacement of the piston rod.