Electronic module for a drug delivery device

Abstract

An electronic module configured for releasable attachment to a drug delivery device (20) comprises a printed circuit board (16c) having an electronic circuit (29), a battery (16b), and a switch for activating the electronic module (16). The switch includes an electrically active contact (28) providing connection with the electronic circuit (29) and a battery contact extension (27) extending from the terminals (16d, 16e) of the battery (16b). The battery contact extension (27) is biased towards the electrical contact (28) for closing a switching gap (30) between the battery contact extension (27) and the electrically activated contact (28), and the battery contact extension (27) is configured to engage an actuation element (11, 6) of the drug delivery device (20) such that the actuation element (11, 6) urges the battery contact extension (27) against the bias, thereby creating the switching gap (30).

Description

TECHNICAL FIELD

[0001] The present invention relates to an electronic module for a drug delivery device, the electronic module comprising a switch for activating the electronic module. BACKGROUND

[0002] Injection or infusion devices, such as injection pens, auto-injectors, auto-pens, patch injectors or patch pumps, use a drive mechanism to expel a drug from the device. The drive mechanism comprises a mechanical assembly for advancing, for example, a piston rod, which advances a stopper in a container or drives a pumping mechanism. Injection or infusion devices can be disposable or reusable devices. These devices mainly use a spring for the mechanical drive or are driven by a gas generated on site or compressed in the cartridge. These mechanical devices have features to provide feedback to the user, such as a click at the beginning of the injection generated by the drive mechanism or a click at the end of the injection. The monitoring functionality of these devices for providing feedback to the user is limited by the mechanical drive mechanism used.

[0003] There is a need to add additional monitoring and communication features to those mechanical devices, for example, by adding an electronic module to the mechanical device. Examples for those electronic modules can be connectivity modules with transmitters and / or receivers to allow communication with other devices, sensing modules for sensing a status of the device or the drug delivery or a patient parameter such as a blood glucose value, location modules indicating a geographical position, timer or calendar modules, communication or training modules comprising a loudspeaker. The electronic module can be added to an existing mechanical drive device as a separate additional device or as an auxiliary device. The additional device can be integrated into the mechanical device by the device manufacturer as a so-called integrated additional device, which can be removed after use.

[0004] The electronic module is configured to monitor a function of the device, such as, for example, the start of an injection, the end of an injection, the hold time after an injection, the removal of the electronic module, the re-attachment of the electronic module to another drug delivery device after use on a drug delivery device, monitoring and counting the number of times the monitoring unit has been attached to a number of devices (life management), the identification of the drug used, etc. The data can be stored in a storage module of the electronic module and the electronic module can be configured to transmit data to an external device or to receive information from an external device.

[0005] The electronic module needs to be powered by a battery and the service life of the module can be limited by the battery capacity and / or the time of activity of the electronic module or at least a part of the electronic module. The electronic module can be activated to switch on the electronic module or a part of the electronic module can be activated for monitoring a function of the drug delivery device. Therefore, the electronic module needs a switch element for activating and / or actuating the electronic module.

[0006] In EP 4122512 Al an auto-injector is disclosed having a module housing enclosing an electronic module releasably attached to a main housing comprising an injection mechanism. The electronic module comprises a separate switch attached to a printed circuit board (PCB) for actuating the module, thereby requiring additional components occupying space in the module.

[0007] WO 2017032586 proposes a monitoring unit for a drug delivery device having an actuation switch. The actuation switch is a separate switch on the PCB, thereby requiring additional length and additional components of the monitoring unit.

[0008] US 2021 / 0196891 Al discloses a drug delivery device housing a monitoring unit powered by a battery and designed to be activated upon dose delivery. The activation is achieved by an insulating portion wedged between the battery and the terminal contact portion, which is designed to be pulled apart by an actuation member operably connected to be axially moved during dose delivery, resulting in the closure of the electronic circuit.

[0009] US 2014 / 243749 Al shows a drug delivery device having an electronic control unit powered by a battery. The battery is in contact at one end with a flexible clip extending from the PCB and at the other end clamps the battery to the PCB. The cover of the device features a battery insulating protrusion wedged between the clip and the battery and removed when the cover is removed, resulting in the activation of the control unit.

[0010] US 2022 / 288325 Al relates to a cover assembly having an electronic control unit of an auto-injector device. The cover is provided with a coil spring that relaxes and closes the electronic circuit upon removal of the cover. The control unit is designed to record a dose delivery event by registering the removal of the cover.

[0011] It is an object of the present invention to improve the electronic module of the prior art. There is a need for a robust and reliable electronic module requiring less components, allowing for a space saving configuration. These objects are solved by the independent claims, and specific variants are disclosed in the dependent claims. Furthermore, a drug delivery device comprising the electronic module is proposed.

[0012] Definitions The term "medicament" or "drug" includes any flowable pharmaceutical preparation suitable for administration by control of a component such as, for example, a cannula or hollow needle, and includes a liquid, solution, gel or fine suspension containing one or more pharmaceutically active ingredients. The medicament can be a composition comprising a single active ingredient, or a pre-mixed or co-formulated composition with more than one active ingredient presented in a single container. The drug includes a medicine, for example a peptide (e.g. insulin, a medicament containing insulin, a medicament containing GLP-1 or a derivatized or analogous preparation), a protein and a hormone, an active ingredient derived from or harvested from a biological source, a hormone- or gene-based active ingredient, a nutritional preparation, an enzyme and other substances in solid (suspended) or liquid form, as well as polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies, and also suitable basic, auxiliary and carrier substances.

[0013] The distal end or distal direction is defined by the direction of the hollow needle configured to penetrate the patient's skin. For an injection device such as an injection pen, this can be the injection needle, and the end of the pen holding the needle or configured to hold the needle is the distal end. For an infusion device, the distal end and distal direction are towards the needle configured to penetrate the patient's skin, which can be along the axis of the device or inclined or perpendicular to the axis of the device. The distal direction in an infusion device represents the direction in which the drug flows towards the inserted needle. The proximal direction or proximal end is opposite to the distal direction or distal end.

[0014] In the claims, the word "comprising" does not exclude other elements or steps, and the SUMMARY

[0015] The present invention relates to an electronic module for a drug delivery device. The electronic module comprises a printed circuit board (PCB), an electronic circuit on the printed circuit board, a battery and a switching element for activating the electronic module. The switching element comprises an electrically activated contact which is part of and connected to the electronic circuit and a battery contact extension which extends from and contacts a terminal of the battery. The battery contact extension is biased towards the electrically activated contact for closing a switching gap between the battery contact extension and the electrically activated contact. The battery contact extension is configured for engaging an actuation element of the drug delivery device which is adapted to compensate for the bias of the battery contact extension and to keep the switching element open in an initial or shipping state of the actuation element, e.g. before drug delivery. The switching gap is a physical or air gap between the battery contact extension and the electrically activated contact without any solid insulator.

[0016] An electronic module is proposed which is configured for releasable attachment to a drug delivery device comprising a printed circuit board with an electronic circuit, a battery and an activation contact providing a connection to the electronic circuit. A battery contact extension extends from a terminal of the battery, the battery contact extension is biased towards the activation contact for closing a switching gap between the battery contact extension and the electrically activated contact. The battery contact extension is configured to engage an actuation element of the drug delivery device such that the actuation element can force the battery contact extension against the bias in or into an open state of the switching element.

[0017] The electronic module can be configured for releasable attachment to a drug delivery device and subsequent detachment from the drug delivery device. The electronic module can be releasably attached to the same or another drug delivery device. The same drug delivery device and the other drug delivery device preferably comprise the same delivery mechanism or the same mechanical interface for connecting the electronic module. The drug delivery device can be an injection device, an auto-injector or a patch injector.

[0018] The printed circuit board can be rigid, flexible or comprise flexible and rigid elements. The combination of rigid and flexible elements can allow rigid PCB elements to be stacked on top of each other for a space saving configuration of the PCB in the electronic module. The battery can be rechargeable or non-rechargeable for powering the electronic module. The battery is preferably connected to the PCB and can be provided in a battery holder. The battery holder can be mechanically connected to the PCB or can be fixed to a part of the housing of the electronic module, for example to the cover or housing of the electronic module. Further components of the electronic module that can be located on the PCB include a microprocessor, a transmitter, a receiver, an antenna, a memory module, a communication module for a user or a scanner or camera. The communication module can comprise a visual display, for example an LCD or OLED display, a speaker or a buzzer. The scanner can be configured to read barcodes or two-dimensional QR codes. The electronic module can comprise an input device, for example a touch-sensitive screen.

[0019] The actuation of the switch element can activate or wake up the electronic module or activate the microprocessor located on the PCB. The actuation of the switch element can also deactivate the electronic circuit or deactivate a part of the electronic circuit.

[0020] The switch element comprises an electrically activated contact or contact area on the electronic circuit or on a part of the electronic circuit. One end of the battery contact extension contacts a terminal of the battery or contacts a battery holder holding the battery. The battery contact extension can also be a part of or extend from a battery holder holding and contacting the battery. The battery contact extension is biased towards the electrically activated contact or contact area and is configured to close a switching gap between the battery contact extension and the electrically activated contact and to close the switch element. The battery contact extension is configured to engage an actuation element of the drug delivery device, which can be a drive element or a signaling element or a display element. The actuation element of the drug delivery device is configured to at least force or axially displace a part of the battery contact extension against the bias, thereby configured to create the switching gap and open the switch element. The switch element is open or not actuated. In comparison to the prior art, no additional switch and actuation element of the drug delivery device can be required, so that the electronic module can be actuated with less components and represents a space saving configuration. This space can be used for example for a battery with a larger capacity.

[0021] Upon separation or removal of the electronic module from the drug delivery device, the switch element can be actuated, as there is no engagement between the actuation element and the battery contact extension and the bias on the battery contact extension closes the switch element.

[0022] When the electronic module is attached to the drug delivery device, then the switch element can be actuated by the delivery mechanism of the drug delivery device. The switch element can be actuated several times, and each actuation of the switch element can trigger a different signal than the signal previously generated by the electronic module. The switch element can be actuated when the module is attached, or can be actuated when the drug delivery device is used during drug delivery, or can be actuated when the electronic module is removed. The switch element can monitor several functions or states of the drug delivery device throughout the lifetime of the drug delivery device.

[0023] When the switching gap is closed for a defined minimum closing time, the electronic circuit or a microprocessor or a receiver / transmitter in the electronic circuit can be activated by the switch element. The wake-up of the electronic circuit can be established when the contact is established (the switch element is closed) for a certain duration, for example more than 10 milliseconds, preferably more than 100 milliseconds. The closing of the switch element can initially start a wake-up procedure of the microprocessor, but if the switch element is not subsequently continuously actuated, the electronic module can return to the sleep mode. This can avoid accidental actuation, for example during a shock (drop test), where the shock leads to a short closing time of the switch element.

[0024] The terminals of the battery can both be in permanent contact with the PCB, thereby powering the electronic module or a part of the electronic circuit permanently. Another part of the electronic circuit can remain in sleep mode. The part of the electronic circuit containing power consuming components, such as the microprocessor or the transmitter, can initially not be powered by the battery. The actuation of the switch element can act as a load switch, thereby increasing and powering the additional components of the electronic circuit. Alternatively, one of the terminals of the battery can be in contact with the PCB, while the other terminal can be connected to the PCB via the switch element, in which case no electrical power is supplied to the electronic circuit until the switch element is operated thereby activating the electronic module.

[0025] The connector between the terminals of the battery and the PCB can have a combined electrical (conductive) function and also provide mechanical support to position the battery or the battery holder on the PCB.

[0026] The battery contact extension of the electronic module can comprise a spring element or spring that biases the battery contact extension towards the electrical activation contact. The spring element or spring can be a coil spring, a torsion spring or a leaf spring. The spring can be attached to the battery holder or can be part of the battery holder.

[0027] The battery contact extension can comprise a detection pin, and the spring element or spring is located between the terminal of the battery and the detection pin. The spring can also be located between the battery holder and the detection pin. The detection pin can be located at a distal end of the battery contact extension and can extend from the spring element.

[0028] The actuation element of the drug delivery device can be configured to abut the detection pin or the distal end of the detection pin of the battery contact extension when the electronic module is attached or integrated into the drug delivery device, thereby creating a switching gap or opening the switching element. During drug delivery, the actuation element of the drug delivery device and the detection pin of the electronic module are preferably moved axially along the longitudinal axis of the delivery device when the actuation element is moved away from the initial or shipping state.

[0029] The detection pin and the spring element can be provided as a single assembly and made of an electrically conductive material, such as metal. Examples are stainless steel or copper. The switching element can be configured as a bi-stable clicker element, which has two preferred configurations, one for a closed switch and one for an open switch. The switching element can be made of a sheet, a wire, or a stamped part. The battery holder, the spring, and the detection pin can be made as a single assembly, thereby reducing the number of components for the electronic module.

[0030] The battery holder holds the battery and contacts the terminals of the battery, and the battery holder can be mechanically fixed to the PCB or another housing part. The contact between the PCB and the battery or the battery holder can provide only mechanical support or can provide only electrically active contact or can provide both mechanical support and electrically active contact.

[0031] In a preferred embodiment, the spring element is a leaf spring, and the detection pin can extend from the leaf spring and be oriented substantially perpendicular to the leaf spring, thereby forming a kink or bend between the leaf spring and the detection pin. Substantially perpendicular is defined as an angle between 80 degrees and 100 degrees, preferably between 85 degrees and 95 degrees. Alternatively, the detection pin is inclined at an angle in the range of 45 degrees to 80 degrees or at an angle of 100 degrees to 145 degrees relative to the leaf spring. The spring can be formed by the kink between the leaf spring and the detection pin.

[0032] The electrically active contact on the electronic circuit can at least partially surround a channel or a boring in the printed circuit board. The electrically active contact can be made of gold or copper and can be integrated and connected to the conductive paths of the electronic circuit. The electrically active contact surrounding the channel is preferably located on one side of the PCB. Alternatively, the electrically active contact is located on both sides of the PCB.

[0033] The detection pin can at least partially pass through or by the channel, and the distal end of the detection pin is configured to engage the actuation element of the drug delivery device. Preferably, the electrically active contact is located on one side of the channel, and the distal end of the detection pin is located at the opposite side of the channel.

[0034] The kink can be configured for contacting the electrically active contact of the electronic circuit on one side of the channel.

[0035] The passage in the PCB can have a fixed size, e.g. a fixed diameter, or can have a variable diameter with respect to a central axis of the passage. The passage can be conical. The distal portion of the passage can comprise a smaller size for (mechanically) guiding the detection pin through the passage, while the proximal portion has a larger size (diameter) for electrically activating the contact. Correct guidance of the battery contact extension can increase reliability, robustness and shock resistance of the switch. The larger size of the entrance portion of the passage for receiving the detection pin can facilitate reducing the sensitivity of the switch element to tolerance variations during manufacturing.

[0036] The PCB can have multiple passages, one passage for guiding the battery contact extension and another passage can provide electrical switching when closing the switching gap. The battery contact can have multiple battery contact extensions.

[0037] The kink can be located at one side of the PCB for contacting the electrically active contact and the distal end of the detection pin can be located at the opposite side of the PCB for contacting the actuation element.

[0038] The electrically active contact can at least partially cover the inner surface of the passage. The contact area can increase from the top surface of the PCB, in which the electrically active contact at least partially surrounds the passage, to include the inner surface of the passage, thereby increasing the reliability of the switch.

[0039] The battery contact extension can comprise a radial or lateral extension and / or a conical portion for contacting the electrically active contact, wherein the radial or lateral extension has an outer dimension larger than an inner dimension of the passage. The inner dimension can be a diameter of the passage. The radial or lateral extension can be shaped as a flange. The conical portion can hang down from the lateral extension or flange. The radial or lateral extension can be adjacent to the kink and the radial or lateral extension can be located between the kink and the conical portion. The radial or lateral extension is configured for contacting the electrically active contact of the electronic circuit surrounding the passage, while the conical portion is configured for engaging a contact surface within the passage of the PCB. The conical portion and / or the flange can remove contaminants or corroded surfaces from the electrically active contact when the switch is closed. The conical portion can be roughened to act as sandpaper, thereby removing a layer of corrosion that can have accumulated during shelf life from the conductive surface.

[0040] When using the drug delivery device, the actuation element of the drug delivery device can be moved axially along the longitudinal axis of the drug delivery device, or tilted relative to the longitudinal axis of the drug delivery device, or rotated around the longitudinal axis of the drug delivery device. When the electronic module is attached to the delivery device, then the actuation element can release the engagement between the actuation element and the battery contact extension, and close the switching gap and actuate the switch. The switch element can be actuated repeatedly during the use of the drug delivery device, for example when attaching the module to the drug delivery device, or at the beginning and / or end of an injection. When the drug delivery device is removed after use, the switching gap can be closed again, since the actuation element is not in contact with the battery extension. Each mechanical actuation of the switch element can activate the electronic module or a part of the electronic module. As an alternative, the actuation can deactivate the electronic module or a part of the electronic module.

[0041] In another embodiment, the actuation element of the drug delivery device indirectly actuates the switch element via a coupling part or coupling member, which can be moved axially, tilted or rotated due to the movement of the actuation assembly during dose delivery, and which can abut the battery contact extension, preferably the detection pin.

[0042] The electronic module can comprise a mechanical interface configured for releasable attachment to or detachable from a complementary mechanical interface on the drug delivery device. The mechanical interface comprises a coupling or coupling part for engaging a complementary coupling or coupling part on the complementary mechanical interface of the drug delivery device. The mechanical interface can be configured for repeated attachment or repeated detachment, or the mechanical interface of the electronic module can be coupled to the complementary mechanical interface on the drug delivery device only once. After detachment, the electronic module can not be attached to an empty device, but only to a ready-to-use or full drug delivery device. This can facilitate that the treatment can only be started from a full drug delivery device.

[0043] The detection pin of the switch element can be part of or located in the mechanical interface of the electronic module. Alternatively, the switch element is located outside the mechanical interface.

[0044] The electronic module described above can be releasably attached or detachably integrated into a drug delivery device. During attachment or integration of the electronic module, the battery contact extension or detection pin can engage an actuation element of the drug delivery device, thereby opening a switch element and creating a switching gap against the bias of a spring. During attachment or integration, a mechanical interface of the electronic module engages a complementary mechanical interface on the drug delivery device. The mechanical interface of the electronic module can have an arm, a resilient arm, a protrusion, a releasable snap-fit connector, a screw-type connector, a bayonet-type connector, a push-turn connector configured to engage a complementary mechanical interface on the drug delivery device, a counterpart of a groove edge, a resilient arm, a screw-type connector or a bayonet-type connector or a push-turn connector. The mechanical interface of the electronic module can be configured to lock or unlock the drug delivery device, e.g. the drug delivery device can only be operated in an unlocked state with an attached or integrated electronic module.

[0045] The drug delivery device can be a spring-driven auto-injector comprising an injection spring for moving a drive element in a distal direction during dose delivery. The injection spring can rotate an actuation element or tilt an actuation element or axially move an actuation element in a distal or delivery direction to release the engagement between the battery contact extension and the actuation element, thereby closing the switch. During injection, the actuation element can be moved in a proximal direction after first being moved in a distal direction, thereby actuating the switch element again.

[0046] While the application has been described in detail in the foregoing drawings and preceding general description, such description being deemed to be illustrative or exemplary only, not limiting. Variations and modifications of the disclosed embodiments can be understood and effected by those skilled in the art and practising the claimed application, according to the study of the drawings, the disclosure and the appended claims. BRIEF DESCRIPTION OF DRAWINGS

[0047] Figure 1 : exploded view of an auto-injector, Figure 2a : Figure 1 : longitudinal sectional view of an auto-injector in the middle, Figure 2b : longitudinal sectional view of an auto-injector in a view perpendicular to Figure 2a : longitudinal sectional view of an auto-injector in a view perpendicular to Figure 3a : longitudinal sectional view of an electronic module according to the prior art with separate switch and detection pin; auto-injector before use, Figure 3b : electronic module according to the prior art of Figure 3a : electronic module according to the prior art of Figure 4a : longitudinal sectional view of an electronic module according to an embodiment of the present disclosure; auto-injector before use, Figure 4b : Figure 4a Electronic module; automatic injector during use, Figure 5a : Perspective view of electronic module; automatic injector before use, Figure 5b : Perspective view of electronic module; automatic injector during use, Figure 6a : Side view of electronic module, switch open, Figure 6b : Side view of electronic module, switch closed, Figure 7a : Perspective view of electronic module with conical part for battery contact extension; switch open, Figure 7b : Perspective view of electronic module with conical part for battery contact extension; switch closed, Figure 8a : Figure 7a Details of, Figure 8b : Figure 7b Details of. DETAILED DESCRIPTION

[0048] Figure 1 An exploded view of the automatic injector is shown. During injection, the elongated sleeve-shaped housing 2 can be grasped by the user and this housing defines a longitudinal axis L. An injection mechanism configured to be driven by a helical compression spring is encapsulated in the housing 2. To illustrate the functioning of the assembly, Figure 2a and 2b depict a longitudinal section of the automatic injector 20. The prefilled syringe 21 (Fig. 2) is housed in the syringe holder 1 and the syringe holder 1 is axially and rotationally fixed to the housing 2 with a snap-fit connection. The automatic injector 20 for delivery to a patient is closed at the distal end by a cap 4 which has to be removed before using the automatic injector. The needle shield 22 of the prefilled syringe 21 is coupled to the cap 4 by a needle shield remover 14 so that removing the cap 4 also removes the needle shield 22, exposing the hollow needle 23. The needle guard sleeve 3 is axially guided by the housing 2 and can be moved relative to the housing 2 along the longitudinal axis L by a distance corresponding to the actuation hub. The needle guard sleeve 3 can be slid in the proximal direction for actuating the injection mechanism for expelling the drug from the automatic injector 20. The mechanical holder 5 is snap-fitted into the housing 2 and rotationally and axially fixed to the housing 2. The mechanical holder 5 comprises a resilient element 5c (holding spring) at the distal end which abuts the proximal end 21a of the prefilled syringe 21 and biases the prefilled syringe distally into the syringe holder 1.

[0049] The injection mechanism comprises a compression spring serving as an injection spring 9. The injection spring 9 is in its initial state almost completely surrounded by the piston rod 7 and a distal end 9a of the injection spring 9 biases the piston rod 7 in distal direction. A proximal end 9b of the injection spring abuts against the holding element 6 and the holding element 6 comprises two arms 6b extending in distal direction from a proximal end 6d and one central pin 6a for guiding the injection spring 9. Each arm 6b comprises a protrusion 6c pointing towards the axis L and both protrusions are engaged with a groove 7a on the outer surface of the piston rod 7. In the initial state of the auto-injector the switching module 8, 15 comprising the switching sleeve 15 and the locking sleeve 8 prevents a deflection of the arms 6b as the arms 6b are constrained within the locking sleeve 8 and thereby prevents a relative movement between the piston rod 7 and the holding element 6 and thereby maintains the injection spring 9 in a compressed state. The piston rod 7 is prevented from moving in distal direction. At least a distal end 15a of the switching sleeve 15 is engaged or abuts with a proximal end 3a of the needle cover sleeve 3. The switching sleeve 15 is biased in distal direction by the needle cover sleeve spring 10. A distal end 10a of the needle cover sleeve spring 10 abuts against an edge 15b on the switching sleeve 15 and a proximal end 10b of the needle cover sleeve spring 10 abuts against the signaling element 11 and the signaling element abuts against the end cap 12 which is axially and rotationally fixed to the housing 2. In the initial state of the auto-injector 20 the force of the needle cover sleeve spring 10 in proximal direction is guided via the signaling element 11 to the end cap 12 of the housing 2. In distal direction the needle cover sleeve spring 10 biases the needle cover sleeve 3 in distal direction via the switching sleeve 15. To start the injection the needle cover sleeve 3 is pushed against the skin of a patient and moved in proximal direction relative to the housing 2 thereby moving the switching module 15, 8 in proximal direction and tensioning the needle cover sleeve spring 10. In the most proximal position of the switching module 15, 8 the locking sleeve 8 can axially engage with the mechanical holder 5 (or alternatively with the signaling element 11 as will be discussed below) and the switching sleeve 15 which is axially guided and splined onto the locking sleeve 8 is held in proximal position by the needle cover sleeve 3 against the bias of the spring force provided by the needle cover sleeve spring 10.

[0050] The proximal movement of the switching module 8, 15 releases the engagement between the protrusions 6c on the holding element 6 and the grooves 7a in the piston rod 7. The spring force is released and the piston rod 7 moves in distal direction while the holding element 6 can move the initial hub in proximal direction until the proximal end 6d of the holding element 6 abuts against the end cap 12 of the housing 2. Optionally a sound or haptic signal is generated upon abutment indicating the start of the injection. The piston rod 7 abuts against the stopper 19 in the pre-filled syringe which moves distally towards the outlet expelling the drug through the needle 23.

[0051] The needle cover sleeve spring 10 is a metal coil spring acting as a compression spring, and the proximal end 10b abuts a signaling element 11 which abuts an end cap 12 of the housing 2 prior to injection. The signaling element 11 comprises two longitudinally extending arms 1 lb each having a protrusion 11a oriented towards the longitudinal axis L. The protrusions 11a engage another groove 7b in the piston rod 7, and the sleeve of the switching module 8, 15 ensures that the signaling element 11 is axially coupled to the piston rod 7 prior to and during the initial phase of the injection. The arms 1 lb with protrusions 11a are also constrained within the locking sleeve 8, preventing the protrusions from being released from the groove. During the initial phase of the injection, the piston rod 7 is advanced distally and thereby also drives the signaling element 11 in distal direction away from the end cap 12 by the locking sleeve 8. The signaling element 11 is moved a distance in distal direction or the tensioning hub until the protrusions 11a are released from the groove 7b of the piston rod 7, as the arms 1 lb are no longer constrained by the locking sleeve 8 and can bend radially outwards. The arms 1 lb have further protrusions 11c pointing in radial outward direction, and those outward protrusions 11c engage the switching module 8, 15, holding the tensioning hub of the signaling element 11. The arms 11c preferably engage the locking sleeve 8, thereby holding the locking sleeve 8 in a proximal position (alternatively, the locking sleeve engages the mechanical holder 5 as described above). The arms 1 lb can slide along the outer surface of the piston rod 7, and at the end of the injection, the piston rod has advanced such that the arms 1 lb of the signaling element 11 can bend radially inwards again, and the signaling element 11 is released from the switching module 8, 15. The signaling element 11 is biased proximally by the needle cover sleeve spring 10, and is accelerated and moved back towards the end cap 12, creating an audible and / or tactile end-of-injection click.

[0052] After the drug has been delivered, the auto-injector 20 is removed from the skin, and the switching sleeve 15 is advanced together with the needle cover sleeve 3 by the needle cover sleeve spring 10, which is at least partially decompressed. The switching sleeve 15 is moved in distal direction and slides along the locking sleeve 8, which has been locked prior to the injection into the mechanical holder 5. The switching sleeve 15 can be locked in the most distal position by the flexible arms 8a of the locking sleeve 8 engaging the cutouts 15c of the switching sleeve 15, preventing the switching sleeve 15 from moving proximally after the injection. The needle cover sleeve 3 can be locked in the most distal position by the arms 1a of the syringe holder 1 extending radially into the grooves 3b of the needle cover sleeve 3, preventing the needle cover sleeve 3 from moving proximally after the injection.

[0053] The end cap 12 is axially and rotationally fixed to the housing 2. The end cap 12 can be snap fitted, glued or welded to the housing 2. If no additional module is added to the auto-injector, the end cap 12 can be the closure cap for the auto-injector, which defines the mechanical assembly of the device in proximal direction. The end cap can provide a protrusion, rib or 3D structure as shock absorber. Preferably, the end cap 12 provides a platform or adapter for adding additional modules to the auto-injector. Preferably, this is the electronic module 16 and the module is enclosed by a closure cap 17 engaging the end cap 12 and / or the housing 2 of the auto-injector. The closure cap 17 can provide a protrusion, rib or 3D structure on the outer surface to act as a shock absorber. Preferably, the module is a releasable module, which can be released and detached from the auto-injector after injection. The electronic module 16 can comprise a sensor or switch 16a and a battery 16b and a printed circuit board 16c. The printed circuit board 16c can comprise a microprocessor, a transmitter / receiver unit, an antenna and / or a light source such as an LED. The light source can be used to signal the device status to the user, e.g. “ready to use” or “injection completed”. The sensor 16a can also be part of the PCB 16c and is configured to detect whether the signaling element 11 is in the proximal-most position. The sensor 16a can be a switch on the PCB 16c which detects whether the signaling element 11 is in the proximal-most position before injection and / or after injection and / or is not in contact with the sensor during injection. The signaling element 11 can have a protrusion extending into the proximal direction and is optionally guided through a passage in the end cap 12 for contacting the sensor 16a. Alternatively, the signaling element 11 indirectly contacts the sensor 16a, e.g. via a pivoting element, a rotating element or an element moving along the pen axis 18 which is part of or coupled to the end cap 12. The microprocessor detects the signal from the sensor 16a and is able to transmit the data of the injection, e.g. time, duration, failure, to an external device using a communication module comprising e.g. a transmitter and / or a receiver.

[0054] The signaling element 11 or an extension of the signaling element 11 can thus directly or indirectly contact the sensor 16a before injection, as the signaling element is in the proximal-most position. During injection, the signaling element is driven in distal direction by the piston rod 7 and the signaling element 11 or its extension can not contact the sensor 16a. At the end of the injection, the signaling element 11 is moved in proximal direction and can contact the sensor 16b again. Each event can be recorded and can be transmitted to an external device or can trigger a visual or audible signal by the electronic module.

[0055] Figure 3a and Figure 3bDetails of an electronic module 16 according to the prior art are shown and comprise a separate switch 16a on a printed circuit board 16c. The electronic module is located between the end cap 12 and the closure cap 17. The electronic module comprises a battery 16b connected to the PCB. The closure cap 17 comprises a hole 17a closed by a transparent plug 25 so that a LED light source 24 on the PCB can provide a light signal to the user. The plug 25 can comprise elastic arms 25a around the hole in the plug which are used to direct the LED light. The elastic arms 25a can also provide a spring force on the surface of the PCB for mechanical fixation of the PCB or for compensation of manufacturing tolerances. The electronic module 16 is attached to the proximal end of the auto-injector by a mechanical interface, for example by a bayonet type connection between the closure cap 17 and the housing 2 or between the closure cap 17 and the end cap 12. The housing 2 encloses the injection mechanism driven by an injection spring 9 which can act on the signaling element 11 and / or the retaining element 6 at different stages of the injection. In Figure 3a and Figure 3b In the embodiment shown in Figs. 1 1 and 12, the signaling element 11 is configured to abut the distal end of the detection pin 18 ( Figure 3a ). During injection, the signaling element 11 moves in the distal direction and actuates the switch 16a ( Figure 3b ). In this embodiment, the detection pin moves along the longitudinal axis of the auto-injector, but can also be tilted or pivoted relative to the longitudinal axis L. The actuation of the switch 16a can register the start of the injection or the end of the injection or trigger the start of the post-injection holding time. Figure 3a and Figure 3b The electronic module according to the prior art shown in Figs. 1 and 2 comprises a separate switch 16a on a PCB which occupies space, in addition, a separate detection pin is used which is part of the auto-injector and is encapsulated in the auto-injector.

[0056] Figure 4aAn electronic module according to the present application is shown. The electronic module is enclosed in a closure cap 17 which is attached to the housing 2 or end cap 12 of an auto-injector. The PCB 16c is located at the proximal end of the extension 12a and the guide sleeve 12b. The battery 16b is fixed to the PCB by a battery holder 26 which contacts the terminals 16d, 16e of the battery 16b. One of the battery holders 26, in this example the one which contacts the negative terminal 16e, comprises a battery contact extension 27. The battery contact extension 27 and the battery holder 26 for the negative terminal are made as one single component from a stamped metal sheet. The battery contact extension 27 comprises a portion which is oriented substantially parallel to the battery terminal and a portion which is oriented substantially perpendicular to the battery terminal. A kink 27b is located between the parallel and perpendicular oriented portions. The portion of the battery contact extension which is oriented perpendicular to the battery terminal provides a detection pin 27c and the portion which is oriented parallel to the terminal provides a leaf spring 27a. The PCB comprises a channel 16f for the detection pin 27c. The distal end 27d of the detection pin 27c is guided by the guide sleeve 12b through a channel 12c in the end cap 12 towards a signalling element 11 of the auto-injector. Prior to use of the auto-injector, the signalling element 11 abuts the distal end 27d of the detection pin and pushes the detection pin 27c in proximal direction against the bias provided by the leaf spring 27a, thereby creating a switching gap between the battery contact extension 27 and the PCB 16c to open a switch which will be discussed in more detail below.

[0057] During use of the auto-injector, Figure 4a The electronic module of Figure 4b is shown in Fig. 2. During dose delivery, the signalling element 11 is driven in distal direction by the injection spring. Due to the bias provided by the leaf spring 27a, the distal end 27d of the detection pin 27c follows the distal movement. The battery contact extension 27 contacts a contact which is part of the electronic circuit 29 located on the PCB 16c, thereby closing the switch.

[0058] Figure 3a and Figure 4a The comparison of Figure 3a shows the effect of replacing the switch 16a according to the prior art by the battery contact extension 27 and the electrically activated contact 28 of the present disclosure. Less parts are required for activating the module by actuating the switch. Furthermore, the space occupied by the switch 16a in Figure 4a can be used for a larger battery with more capacity in

[0059] Figure 5aA perspective view of the electronics module 16 without the closure cap is shown. The battery seat 26 contacts the positive terminal 16d (top surface of the battery) and the extension 26a is connected to the PCB 16c, providing mechanical support for the battery seat 26 and / or providing electrical activation contact to the electronic circuitry 29 on the PCB. The extension 26a also extends from the battery seat that contacts the negative terminal (bottom surface of the battery). In Figure 5a the embodiment shown in Figure 5a , two extensions 26a extend from the battery seat 26 to provide mechanical support for the battery and / or to provide electrical contact to the electronic circuitry 29 on the PCB. The battery contact extension 27 is located between the two extensions 26a for the battery seat to contact the negative terminal or bottom surface of the battery. In Figure 5b , the auto-injector before use is shown and the battery contact extension 27 is moved in the proximal direction against the bias of the leaf spring so that the battery contact extension 27 does not contact the electrical activation contact 28, e.g. a switch, that is part of the electronic circuitry 29 (27, 28 is open). In , the auto-injector during use is shown and the switch (27, 28) is closed.

[0060] Figure 6a In Figure 6b , a side view of the electronics module with the switch open is shown and in Figure 6a , a side view of the electronics module with the switch closed is shown. The two battery seats 26 with their extensions 26a are positioned and hold the battery 16b on top of the PCB 16c. The battery contact extension 27 extends from the negative battery terminal 16e. The kink 27b of the battery contact extension is located between the leaf spring 27a and the detection pin 27c. The PCB 16c comprises a channel 16f for the detection pin 27c and the distal end 27d is configured for engaging the drive element of the auto-injector, thereby pushing the battery contact extension 27 in the proximal direction against the bias of the leaf spring. In Figure 6b , the battery contact extension 27 does not contact the electrical activation contact 28 (switch open) and in , the switch is closed.

[0061] In Figure 7a and Figure 7b , perspective bottom views of the electronics module with a sectional cut are shown and Figure 8a and 8b show details. The battery contact extension 27 is made from a stamped metal sheet, where the detection pin 27c is formed as a narrow extension adjacent to the kink 27b, leaving a lateral extension 27e on one side of the channel 16f in the PCB when the detection pin 27c is guided through the channel 16f. A tapered portion 27f is hanging down from the lateral extension 27e (details as in Figure 8aThe electrically active contact 28 on the PCB surrounds the channel 16f and can contact the lateral extension 27e of the battery contact extension 27 for closing the switch 27, 28. In Figure 7a and Figure 8a The switch is open in Figure 7b and Figure 8b The switch is closed and the lateral extension 27e of the battery contact extension 27 contacts the electrically active contact 28. As an option, the electrically active contact can cover at least a part of the surface of the channel 16f itself. The electrically active contact in the channel 28a is configured for contacting the tapered portion 27f. The tapered portion can remove deposits or corrosion products from the surface of the contact 28, 28a when moving from the open switch ( Figure 8a ) to the closed switch ( Figure 8b ).

[0062] Part annotation 1 syringe holder 15c cutout 1a arm 16 electronic module 2 housing 16a prior art sensor / switch 3 needle cover sleeve 16b battery 3a proximal end 16c printed circuit board, PCB 3b groove 16d battery terminal (+) 4 cap 16e battery terminal (-) 5 mechanical holder 16f channel PCB 5c holding spring 17 closure cap 6 holding element 17a hole 6a center pin, guide pin 18 pivot element, detection pin 6b arm 19 stopper 6c protrusion 20 auto-injector 6d proximal end 21 pre-filled syringe 7 piston rod 21a proximal end 7a groove 22 needle shield 7b groove 23 hollow needle 8 locking sleeve 24 LED 8a flexible arm 25 transparent stopper 9 injection spring 25a wing 9a distal end 26 battery seat 9b proximal end 26a extension 10 needle cover sleeve spring 27 battery contact extension 10a distal end 27a leaf spring 10b proximal end 27b kink 11 signaling element 27c detection pin 11a protrusion 27d distal end 11b arm 27e lateral extension 11c protrusion 27f tapered portion 12 end cap 28 electrically activated contact PCB 12a protrusion / edge 28a electrically activated contact passage 12b guide sleeve 29 electronic circuit PCB 12c passage end cap 30 switching gap 14 needle shield remover L longitudinal axis 15 switching sleeve 8, 15 switching module 15a distal end 27, 28 switch 15b edge

Claims

1. An electronics module configured for a drug delivery device (20), comprising - a printed circuit board (16c) with an electronic circuit (29), - a battery (16b), - a switching element for activating the electronics module (16), characterized in that the switching element comprising - an electrical activation contact (28) provided in connection with the electronic circuit (29), - a battery contact extension (27) extending from a terminal (16d, 16e) of the battery (16b), wherein the battery contact extension (27) is biased towards the electrical activation contact (28) for closing a switching gap (30) between the battery contact extension (27) and the electrical activation contact (28), and wherein the battery contact extension (27) is configured to engage an actuation element (11, 6) of the drug delivery device (20) such that the actuation element (11, 6) pushes the battery contact extension (27) against the bias to maintain the switching element open.

2. The electronic module of claim 1, wherein, The battery contact extension (27) comprises a spring element (27a) biasing the battery contact extension (27) towards the electrical activation contact (28).

3. The electronic module of claim 2, wherein, The battery contact extension (27) comprises a detection pin (27c), and wherein the spring element (27a) is located between the terminal (16d, 16e) of the battery (16b) and the detection pin (27c).

4. The electronic module of claim 3, wherein, The detection pin (27c) of the battery contact extension (27) is adapted to abut the actuation element (11, 6) of the drug delivery device (20) in a direction along a longitudinal axis of the drug delivery device.

5. The electronic module of claim 4, wherein, The detection pin (27c) and the spring element (27a) are provided as a single component made of an electrically conductive material.

6. The electronic module of claim 5, wherein, The spring element is a leaf spring (27a), and wherein the detection pin (27c) is oriented substantially perpendicular to the leaf spring (27a), forming a kink (27b) between the leaf spring (27a) and the detection pin (27c).

7. The electronic module of claims 4-6, wherein, The electrical activation contact (28) at least partially surrounds a channel (16f) in the printed circuit board (16c).

8. The electronic module of claim 7, wherein, The detection pin (27c) at least partially passes through the channel (16f), and a distal end (27d) of the detection pin (27c) is configured to engage the actuation element (11, 6) of the drug delivery device (20).

9. The electronic module of claim 8, wherein, The electrical activation contact (28) at least partially covers an inner surface of the channel (16f).

10. The electronic module of claim 9, wherein, The battery contact extension (27) comprises a lateral extension (27e) and a tapered portion (27f) for contacting the electrical activation contact (28, 28a), wherein the lateral extension (27e) has an outer dimension larger than an inner dimension of the channel (16f).

11. The electronic module of any of the preceding claims, wherein, When using the drug delivery device, the engagement between the actuation element (11, 6) and the battery contact extension (27) is adapted to be released and closed when the actuation element (11, 6) of the drug delivery device (20) is axially moved along the longitudinal axis of the drug delivery device (20), or tilted relative to the longitudinal axis of the drug delivery device (20), or rotated around the longitudinal axis of the drug delivery device (20).

12. The electronic module according to any of the preceding claims, further comprising a mechanical interface configured for releasable attachment to the drug delivery device (20).

13. The electronic module of claim 12, wherein, The detection pin (27c) is part of or located in the mechanical interface.

14. A drug delivery device comprising an electronic module according to any of the preceding claims, the electronic module being releasably attached or integrated into the drug delivery device (20).

15. The drug delivery device of claim 14, wherein, The drug delivery device (20) is a spring driven auto-injector and wherein an injection spring (9) moves a drive element (7) in a distal direction during drug delivery and rotates the actuation element (11, 6) or tilts the actuation element (11, 6) or axially moves the actuation element (11, 6) in the distal direction to release the engagement between the battery contact extension (27) and the actuation element (11, 6).

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