Electronic modules for drug delivery devices

Abstract

An electronic module configured to be removably attached to a drug delivery device (20) comprises a printed circuit board (16c) having an electronic circuit (29), a battery (16b), and a switch for operating the electronic module (16). The switch comprises an electrically operated contact (28) that provides connection to the electronic circuit (29) and a battery contact extension (27) extending from terminals (16d, 16e) of the battery (16b). The battery contact extension (27) is biased toward the electrical contact (28) to close a switching gap (30) between the battery contact extension (27) and the electrically operated contact (28), and the battery contact extension (27) is configured to engage with the operating elements (11, 6) of the drug delivery device (20) such that the operating elements (11, 6) push 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, which includes a switch for operating the electronic module.

Background Art

[0002] Injection or infusion devices such as injection pens, autoinjectors, autopen, patch syringes, or patch pumps use a drive mechanism to eject a drug from the device. The drive mechanism includes, for example, mechanical components for advancing a piston rod that advances a stopper in a reservoir or for driving a pump mechanism. These injection or infusion devices may be disposable or reusable devices. These devices are mainly mechanically driven using a spring or driven by a gas generated on-site or a compressed gas in a cartridge. These mechanical devices have functions for providing feedback to the user, such as a click sound at the start of injection or a click sound at the end of injection generated by the drive mechanism. The monitoring functions of these devices for providing feedback to the user are limited by the mechanical drive mechanisms used.

[0003] For example, by adding an electronic module to a mechanical device, it is necessary to include additional monitoring and communication functions in these mechanical devices. Examples of electronic modules can be a connection module having a transmitter and / or receiver enabling communication with other devices, a detection module for detecting device or drug delivery status, or patient parameters such as blood glucose level, a position module indicating geographical location, a timer or calendar module, and a communication or training module including a speaker. The electronic module may be added as an independent additional or auxiliary device to an existing mechanically driven device. The additional device may be incorporated into the mechanical device by the device manufacturer as a so-called built-in add-on that can be removed after use.

[0004] The electronic module is configured to monitor device functions such as, for example, the initiation of injection, the end of injection, the retention time after injection, the removal of the electronic module, the reattachment of the electronic module to another drug delivery device after use in one drug delivery device, monitoring and counting the number of times the monitoring unit has been attached to multiple devices (lifetime management), and the identification of the drug being used. The data can be stored in the electronic module's memory 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 must be powered by a battery, and the module's usable time may be limited by the battery capacity and / or the time the electronic module is operating, or at least a part of the electronic module is operating. The electronic module may be activated to switch on the electronic module, or a part of the electronic module may be activated to monitor the function of the drug delivery device. Therefore, the electronic module requires a switch element to start and / or operate the electronic module.

[0006] EP4122512Al discloses an automatic syringe having a module housing that encloses an electronic module, the electronic module being removably mounted in a main housing that includes an injection mechanism. The electronic module includes a separate switch mounted on a printed circuit board (PCB) for operating the module, thereby requiring additional components that occupy space within the module.

[0007] International Publication No. 2017032586 presents a monitoring unit for a drug delivery device having an actuation switch. The actuation switch is a separate switch located on the PCB, thereby requiring additional components and an additional length for the monitoring unit.

[0008] U.S. Patent Application Publication 2021 / 0196891(A1) discloses a drug delivery device that houses a monitoring unit powered by a battery and designed to be activated upon dose delivery. This activation is performed by an insulating component compressed between the battery and terminal contacts, which is designed to be retracted by being operably connected to an actuating member that moves axially upon dose delivery, thereby closing an electronic circuit.

[0009] U.S. Patent Application Publication No. 2014 / 243749(A1) describes a drug delivery device having an electronically controlled unit powered by a battery. The battery extends from a PCB at one end and contacts a flexible clip that secures the battery to the PCB at the other end. The device's cap features a battery insulating projection that is pressed between the clip and the battery and is released when the cap is removed, thereby activating the control unit.

[0010] U.S. Patent Application Publication No. 2022 / 288325(A1) relates to a cap assembly having an electronic control unit for an autoinjector device. The cap is equipped with a helical spring, which loosens and closes an electronic circuit when the cap is removed. The control unit is designed to record a dose delivery event by recording the removal of the cap.

[0011] The object of the present invention is to improve upon the prior art in electronic modules. There is a need for a robust and reliable electronic module that requires fewer components, thereby enabling a space-saving configuration. These objectives are addressed by the independent claims, and specific modifications are disclosed in the dependent claims. Furthermore, a drug delivery device including an electronic module is presented. definition The term “drug” or “medicine” includes any fluid pharmaceutical preparation suitable for controlled administration by means such as a cannula or hollow needle, and includes liquids, solutions, gels, or microsuspensions containing one or more pharmaceutically active ingredients. A drug may be a composition containing a single active ingredient, or a pre-mixed or co-compounded composition having two or more active ingredients in a single container. A drug includes drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing drugs or their inducers or analogues), proteins and hormones, active ingredients of biological origin or derived from biological sources, hormone or gene-based active ingredients, nutritional preparations, enzymes, and other substances in solid (suspension) or liquid form, but also includes polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies, and appropriate basic substances, auxiliary substances, and carrier substances.

[0012] The distal end or distal direction is defined by the direction of the hollow needle configured to enter the patient's skin. In injection devices such as injection pens, this can be the injection needle, and the distal end is the end of the pen that holds, or is configured to hold, the needle. In infusion devices, the distal end and distal direction is the direction of the needle configured to enter the patient's skin, which may be along the axis of the device, or it may be inclined or perpendicular to the axis of the device. In infusion devices, the distal direction indicates the direction in which the drug flows toward the insertion needle. The proximal direction or proximal end is opposite to the distal direction or distal end.

[0013] In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude plurals. For example, “a battery extension” does not exclude the fact that there may be two battery extensions that functionally or structurally serve the purpose of “a battery extension.” The mere fact that a particular element or step is described in a separate claim does not preclude the existence of further meaningful combinations of these elements or steps. [Overview of the Initiative] [Means for solving the problem]

[0014] The present invention relates to an electronic module for a drug delivery device. The electronic module includes a printed circuit board (PCB), electronic circuits arranged on the PCB, a battery, and a switch element for operating the electronic module. The switch element is part of the electronic circuit and includes an electrically operated contact connected to the electronic circuit and a battery contact extension that extends from the battery terminals and contacts the battery terminals. The battery contact extension is biased toward the electrically operated contact to close the switching gap between the battery contact extension and the electrically operated contact. The battery contact extension is configured to engage with an operating element of a drug delivery device, which is configured to counteract the biasing of the battery contact extension and maintain the switch element in an open state in the initial or shipping state of the operating element, for example, before drug delivery. The switching gap is a physical gap or void between the battery contact extension and the electrically operated contact, in which there is no solid insulator.

[0015] An electronic module is presented which includes a printed circuit board having electronic circuits, a battery, and an operating contact providing a connection to the electronic circuits, configured to be removably attached to a drug delivery device. A battery contact extension extends from the terminals of the battery and is biased toward the operating contact to close the switching gap between the battery contact extension and the electrical operating contact. The battery contact extension is configured to engage with the operating element of the drug delivery device such that the operating element pushes the battery contact extension against the bias, bringing the switching element into an open state.

[0016] The electronic module may be configured to be detachably mounted to a drug delivery device and subsequently detached from the drug delivery device. The electronic module may be detachably mounted to the same or another drug delivery device. The same drug delivery device and another drug delivery device preferably include the same delivery mechanism or the same mechanical interface for connecting the electronic module. The drug delivery device may be an injection device, an auto-injector, or a patch injector.

[0017] The printed circuit board may be rigid or flexible, or may include both flexible and rigid elements. By combining rigid and flexible elements, rigid PCB elements can be stacked on top of each other for a space-saving configuration of the electronic module's PCB. The battery for supplying power to the electronic module may be rechargeable or non-rechargeable. The battery may preferably be connected to the PCB and housed in a battery holder. The battery holder may be mechanically connected to the PCB or fixed to part of the electronic module's housing, such as the electronic module's closure cap or housing. Further components of the electronic module that can be placed on the PCB include a microprocessor, transmitter, receiver, antenna, memory module, user communication module, or scanner or camera. The communication module may include a visual display device such as an LCD or OLED display, a speaker, or a buzzer. The scanner may be configured to read barcodes or two-dimensional QR codes (registered trademark). The electronic module may include input devices such as a touch-sensitive screen.

[0018] Activating a switch element can activate or wake up an electronic module, or activate a microprocessor located on the PCB. Activating a switch element can also deactivate an electronic circuit, or deactivate a part of an electronic circuit.

[0019] The switch element includes an electrically operated contact or contact area in or as part of an electronic circuit. One end of the battery contact extension contacts a terminal of the battery or a battery holder that holds the battery. The battery contact extension may also be part of a battery holder that holds and contacts the battery, or it may extend from the battery holder. The battery contact extension is biased toward the electrically operated contact or contact area and configured to close the switching gap between the battery contact extension and the electrically operated contact, thereby closing the switch element. The battery contact extension is configured to engage with an actuating element of a drug delivery device, which may be a drive element, signaling element, or indicator element. The actuating element of the drug delivery device is configured to push or move at least a portion of the battery contact extension against bias, thereby creating a switching gap and opening the switch element. The switch element is open or not actuated. Compared to the prior art, additional switches and actuating elements of the drug delivery device can be eliminated, resulting in an electronic module that can operate with fewer components and exhibits a space-saving configuration. This space can be used, for example, for a battery with a larger capacity.

[0020] When the electronic module is removed from or taken away from the drug delivery device, the engagement between the actuating element and the battery contact extension is lost, and the biasing force on the battery contact extension closes the switch element, thus allowing the switch element to be activated.

[0021] When an electronic module is attached to a drug delivery device, the delivery mechanism of the drug delivery device can activate a switch element. The switch element can be activated multiple times, and each activation can produce a different signal from the one previously generated by the electronic module. The switch element can be activated when the module is attached, when the drug delivery device is used for drug delivery, or when the electronic module is removed. The switch element can monitor several functions or states of the drug delivery device over its available lifespan.

[0022] When the switching gap is closed for a defined minimum closing time, an electronic circuit, or the microprocessor or receiver / transmitter of an electronic circuit, can be activated by the switch element. The wake-up of the electronic circuit can be established when contact is established (the switch element is closed) for a specific time, for example, longer than 10 milliseconds, preferably longer than 100 milliseconds. When the switch element is closed, the wake-up procedure of the microprocessor can be initiated first, but if continuous operation of the switch element does not continue, the electronic module can return to sleep mode. This prevents unintended operation, such as the switch element briefly closing due to impact (drop test).

[0023] Both battery terminals are permanently in contact with the PCB, thereby supplying power to an electronic module or a part of an electronic circuit. Another part of the electronic circuit may remain in sleep mode. Parts of the electronic circuit that include power-consuming components such as a microprocessor or transmitter may not initially be powered by the battery. The operation of a switch element acts as a load switch, thereby adding and powering further components of the electronic circuit. Alternatively, one terminal of the battery can be in contact with the PCB, and the other terminal can be connected to the PCB via a switch element, in which case power is not supplied to the electronic circuit until the switch element is activated and thereby activates the electronic module.

[0024] The connector between the battery terminals and the PCB combines electrical (conductive) function and mechanical support, allowing the battery or battery holder to be positioned on the PCB. The battery contact extension of the electronic module may include a spring element or spring that biases the battery contact extension toward the electrically operated contact. The spring element or spring may be a coil spring, a torsion spring, or a leaf spring. The spring may be attached to the battery holder or may be part of the battery holder.

[0025] The battery contact extension may include a detection pin, and a spring element or spring is positioned between the battery terminals and the detection pin. The spring may also be positioned between the battery holder and the detection pin. The detection pin may be at the distal end of the battery contact extension or may extend from the spring element.

[0026] The actuating element of the drug delivery device can be configured to abut against the detection pin of the battery contact extension or the distal end of the detection pin when the electronic module is attached to or incorporated into the drug delivery device, thereby generating a switching gap or opening a switch element. The actuating element of the delivery device and the detection pin of the electronic module preferably move axially along the longitudinal axis of the delivery device when the actuating element moves away from the initial or shipped state during drug delivery.

[0027] The detection pin and the spring element may be provided as an integral component and may be made of a conductive material such as metal. Examples include stainless steel or copper. The switch element can be configured as a bistable clicker element having two preferred configurations: a configuration where the switch is closed and a configuration where the switch is open. The switch element can be made from a sheet, wire, or a pressed part. The battery holder, the spring, and the detection pin can be made as an integral component, thereby reducing the number of parts used in the electronic module.

[0028] The battery holder holds the battery and contacts the terminals of the battery. The battery holder may be mechanically fixed to a PCB or another housing part. The contact between the PCB and the battery or the battery holder may provide only mechanical support, only electrical operating contact, or both mechanical support and electrical operating contact.

[0029] In a preferred embodiment, the spring element is a leaf spring, and the detection pin can extend from the leaf spring, be oriented substantially perpendicular to the leaf spring, and form a bend or a bend portion 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 tilted at an angle in the range between 45 degrees and 80 degrees or between 100 degrees and 145 degrees with respect to the leaf spring. The spring may be formed by a bend between the leaf spring and the detection pin.

[0030] Electrical operating contacts of an electronic circuit can at least partially surround a passage or hole in a printed circuit board. Electrical operating contacts may be made of gold or copper, may be incorporated into the conductive path of the electronic circuit, or may be connected to the conductive path of the electronic circuit. Electrical operating contacts surrounding a passage are preferably located on one side of the PCB. Alternatively, electrical operating contacts may be located on both sides of the PCB.

[0031] The detection pin can pass through or penetrate at least partially the passage, and the distal end of the detection pin is configured to engage with an operating element of a drug delivery device. Preferably, the electrical operating contact is on one side of the passage, and the distal end of the detection pin is on the opposite side of the passage.

[0032] The bent portion can be configured to contact the electrical contacts of the electronic circuit on one side of the passage. The PCB passages may have fixed dimensions, such as a fixed diameter, or they may have a variable diameter with respect to the central axis of the passage. The passages may taper. The distal portion of the passage may include a smaller dimension for (mechanically) guiding the detection pin through the passage, while the proximal portion has a larger dimension (diameter) for the electrical operating contact. Properly guiding the battery contact extension can improve the reliability, robustness, and shock resistance of the switch. Making the entrance portion of the passage for receiving the detection pin larger can be beneficial in reducing the sensitivity of the switch element to variations in manufacturing tolerances.

[0033] The PCB may have multiple pathways, one for guiding the battery contact extensions and another for providing electrical switching when closing the switching gap. The battery contacts may have multiple battery contact extensions.

[0034] The bent portion is positioned on one side of the PCB and can contact the electrical operating contact, while the distal end of the detection pin is on the opposite side of the PCB and can contact the operating element. The electrical contacts can at least partially cover the inner surface of the passage. The contact area is extended from the top surface of the PCB to at least partially surround the passage so that the electrical contacts include the inner surface of the passage, thereby increasing the reliability of the switch.

[0035] The battery contact extension may include a radial extension or a lateral extension and / or a tip for contacting the electrically operated contacts, in which case the outer dimension of the radial extension or lateral extension is greater than the inner dimension of the passage. The inner dimension may be the diameter of the passage. The radial extension or lateral extension may be shaped as a flange. The tip may hang from the lateral extension or flange. The radial extension or lateral extension may be adjacent to a bend, or it may be positioned between the bend and the tip. The radial extension or lateral extension is configured to contact the electrically operated contacts of the electronic circuit surrounding the passage, while the tip is configured to engage with the contact surface inside the passage of the PCB. The tip and / or flange can remove contaminants or corrosive surfaces from the electrically operated contacts when the switch is closed. The tip may be roughened to act as sandpaper, thereby removing corrosive layers that may accumulate from the conductive surface during storage.

[0036] The operating element of a drug delivery device may move axially along the longitudinal axis of the drug delivery device, or tilt with respect to the longitudinal axis, or rotate about the longitudinal axis when the drug delivery device is in use. When the electronic module is attached to the delivery device, the operating element disengages from the battery contact extension, closes the switching gap, and activates the switch. The switching element can be repeatedly activated when the drug delivery device is in use, for example, when the module is attached to the drug delivery device, or at the start and / or end of an injection. When the drug delivery device is removed after use, the switching gap can be closed again because the operating element is no longer in contact with the battery extension. Each time the switching element is mechanically activated, the electronic module or a part of the electronic module can be activated. Alternatively, activation can deactivate the electronic module or a part of the electronic module.

[0037] In another embodiment, the actuating element of the drug delivery device indirectly acts on a switch element via a coupling or coupling member that can move, tilt, or rotate in the axial direction by the movement of the actuating part during dose delivery, the coupling or coupling member can contact a battery contact extension, preferably a detection pin.

[0038] The electronic module may include a mechanical interface configured to be detachably attached to a complementary mechanical interface of a drug delivery device. The mechanical interface includes a coupler or coupling means for engaging with a complementary coupler or coupling means of the complementary mechanical interface of the drug delivery device. The mechanical interface may be configured to be repeatedly attached and detached, or the mechanical interface of the electronic module may be coupled to the complementary mechanical interface of the drug delivery device only once. After being removed, the electronic module cannot be attached to an (empty) device and can only be attached to a drug delivery device that is ready for use or filled with drug. This facilitates the initiation of treatment only with a drug-filled drug delivery device.

[0039] The detection pins of the switch element may be part of the mechanical interface of the electronic module, or they may be located on the mechanical interface. Alternatively, the switch element may be located outside the mechanical interface.

[0040] The electronic module described above can be detachably mounted to or detachably integrated into a drug delivery device. Battery contact extensions or detection pins can engage with the operating elements of the drug delivery device during mounting or integration of the electronic module, thereby opening the switch elements and creating a switching gap against spring bias. The mechanical interface of the electronic module engages with the complementary mechanical interface of the drug delivery device during mounting or integration. The mechanical interface of the electronic module may have arms, elastic arms, projections, detachable snap-fit ​​connectors, screw connectors, bayonet connectors, or push-in rotary connectors configured to engage with the complementary mechanical interface of the drug delivery device, including recesses, rims, elastic arms, screw connectors, or mating bayonet or push-in rotary connectors. The mechanical interface of the electronic module may be configured to lock or unlock the drug delivery device, for example, the drug delivery device may only be able to operate in a unlocked state from the mounted or integrated electronic module.

[0041] The drug delivery device may be a spring-driven automatic injector that includes an injection spring for moving the drive element distally when delivering a dose. The injection spring can rotate or tilt the actuating element, or move the actuating element axially in the distal or delivery direction, thereby disengaging the battery contact extension from the actuating element and closing the switch. During injection, the actuating element is first moved distally and then proximally, thereby reactivating the switch element.

[0042] The present invention is described in detail in the following drawings and the above-mentioned general description, but such description is intended to be descriptive or illustrative and not limiting. Variations of the disclosed embodiments can be understood and practiced by those skilled in the art and those practicing the claimed invention by examining the drawings, the disclosure and the appended claims. [Brief explanation of the drawing]

[0043] [Figure 1] This is an exploded view of an automatic syringe. [Figure 2] Figure 2a is a longitudinal cross-sectional view of the automatic syringe shown in Figure 1. Figure 2b is a longitudinal cross-sectional view of the automatic syringe perpendicular to Figure 2a. [Figure 3] Figure 3a is a longitudinal cross-sectional view of a prior art electronic module having independent switches and detection pins, with the automatic syringe before use. Figure 3b is a diagram of the prior art electronic module of Figure 3a, with the automatic syringe in use. [Figure 4] Figure 4a is a longitudinal cross-sectional view of an electronic module according to an embodiment of the present disclosure, with the automatic syringe before use. Figure 4b is a diagram of the electronic module of Figure 4a, with the automatic syringe in use. [Figure 5] Figure 5a is a perspective view of the electronic module, with the auto-syringe before use. Figure 5b is a perspective view of the electronic module, with the auto-syringe in use. [Figure 6] Figure 6a is a side view of the electronic module with the switch open. Figure 6b is a side view of the electronic module with the switch closed. [Figure 7] Figure 7a is a perspective view of an electronic module with a battery contact extension tip, and the switch is open. Figure 7b is a perspective view of an electronic module with a battery contact extension tip, and the switch is closed. [Figure 8] Figure 8a is a detailed view of Figure 7a. Figure 8b is a detailed view of Figure 7b. [Modes for carrying out the invention]

[0044] Figure 1 shows an exploded view of the auto-injector. The elongated, sleeve-shaped housing 2 can be grasped by the user during injection, and this housing defines the longitudinal axis L. The injection mechanism, configured to be driven by a coiled compression spring, is enclosed within the housing 2. To illustrate the function of the components, Figures 2a and 2b show longitudinal cross-sections of the auto-injector 20. The pre-filled syringe 21 (Figure 2) is received in the syringe holder 1, which is secured to the housing 2 axially and rotationally by a snap-fit ​​connection. The auto-injector 20, provided to the patient, is closed at the distal end by a pen cap 4, which must be removed before using the auto-injector. The needle shield 22 of the pre-filled syringe 21 is coupled to the cap 4 by a needle shield remover 14, so that when the pen cap 4 is removed, the needle shield 22 is also removed, thereby exposing the hollow needle 23. The needle cover sleeve 3 is guided axially by the housing 2 along its longitudinal axis and can be moved relative to the housing 2 by a distance corresponding to the actuation hub. The needle cover sleeve 3 can slide proximal to actuate the injection mechanism and dispense the drug from the auto-injector 20. The mechanic holder 5 snaps into the housing 2 and is fixed to the housing 2 in the rotational and axial directions. The mechanic holder 5 includes an elastic element 5c (retaining spring) at its distal end, which contacts the proximal end 21a of the pre-filled syringe 21 and biases the pre-filled syringe distally into the syringe holder 1.

[0045] The injection mechanism includes a compression spring that functions as an injection spring 9. In its initial state, the injection spring 9 is almost completely enclosed by the piston rod 7, and the distal end 9a of the injection spring 9 biases the piston rod 7 distally. The proximal end 9b of the injection spring abuts against a retaining element 6, which includes two arms 6b extending distally from the proximal end 6d and a central pin 6a for guiding the injection spring 9. Each arm 6b includes a projection 6c oriented toward the axis L, and both projections engage with recesses 7a on the outer surface of the piston rod 7. In the initial state of the automatic syringe, the switching module 8, 15, which includes a switching sleeve 15 and a locking sleeve 8, prevents distortion of the arms 6b so that the arms 6b are constrained within the locking sleeve 8, thereby preventing relative movement between the piston rod 7 and the retaining element 6, and thus keeping the injection spring 9 compressed. The piston rod 7 is prevented from moving distally. At least the distal end 15a of the switching sleeve 15 engages with or abuts against the proximal end 3a of the needle cover sleeve 3. The switching sleeve 15 is biased distally by the needle cover sleeve spring 10. The distal end 10a of the needle cover sleeve spring 10 abuts against the rim 15b of the switching sleeve 15, and the proximal end 10b of the needle cover sleeve spring 10 abuts against a signal element 11, which abuts against an end cap 12 fixed to the housing 2 in the axial and rotational directions. In the initial state of the automatic syringe 20, the proximal force of the needle cover sleeve spring 10 is directed to the end cap 12 of the housing 2 via the signal element 11. In the distal direction, the needle cover sleeve spring 10 biases the needle cover sleeve 3 distally via the switching sleeve 15. To initiate the injection, the needle cover sleeve 3 is pressed against the patient's skin and moved proximal to the housing 2, thereby moving the switching modules 15 and 8 proximal to the needle cover sleeve spring 10.At the most proximal position of the switching modules 15 and 8, the locking sleeve 8 can engage axially with the mechanic holder 5 (or, alternatively, with the signal element 11 discussed below), while the switching sleeve 15, which is axially guided and spline-coupled to the locking sleeve 8, is held in the proximal position by the needle cover sleeve 3 against the biasing force of the spring force provided by the needle cover sleeve spring 10.

[0046] The proximal movement of the switching modules 8 and 15 disengages the projection 6c of the retaining element 6 from the recess 7a of the piston rod 7. The spring force is released, and the piston rod 7 moves distally, while the retaining element 6 is allowed to move its initial hub proximal until its proximal end 6d contacts the end cap 12 of the housing 2. Optionally, an acoustic or tactile signal is generated at the time of contact to indicate the start of injection. The piston rod 7 contacts the stopper 19 in the prefilled syringe, moving it distally toward the outlet, thereby discharging the drug through the needle 23.

[0047] The needle cover sleeve spring 10 is a metal coil spring acting as a compression spring, with its proximal end 10b abutting a signal element 11 that abuts against the end cap 12 of the housing 2 before injection. The signal element 11 includes two longitudinally extending arms 11b, each having a projection 11a oriented toward the longitudinal axis L. The projections 11a engage with another recess 7b of the piston rod 7, and the sleeves of the switching modules 8, 15 ensure that the signal element 11 is axially coupled to the piston rod 7 before injection and in the initial stages of injection. The arms 11b with the projections 11a are also constrained within the locking sleeve 8, thereby preventing the projections from disengaging from the recesses. In the initial stages of injection, the piston rod 7 advances distally, thereby driving the signal element 11 distally away from the end cap 12 via the locking sleeve 8. When the arm 11b is no longer constrained by the locking sleeve 8 and can bend radially outward, the signal element 11 is moved distally by a certain distance or under tension on the hub until the projection 11a disengages from the recess 7b of the piston rod 7. The arm 11b has another projection 11c oriented radially outward, and these outward projections 11c engage with the switching modules 8, 15 and maintain tension on the hub of the signal element 11. The arm 11c preferably engages with the locking sleeve 8, thereby keeping the locking sleeve 8 in a proximal position (alternatively, the locking sleeve engages with the mechanic holder 5 as discussed above). The arm 11b can slide along the outer surface of the piston rod 7, and at the end of injection, the piston rod advances so that the arm 11b of the signal element 11 can again bend radially inward and the signal element 11 disengages from the switching modules 8, 15. The signal element 11 is biased proximal by the needle cover sleeve spring 10, accelerated and retracted toward the end cap 12, thereby generating an audible and / or tactile click sound indicating the end of injection.

[0048] 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 released. The switching sleeve 15 moves distally and slides along the locking sleeve 8, which was locked to the mechanic holder 5 before injection. The switching sleeve 15 is locked in its most distal position by the flexible arm 8a of the locking sleeve 8 engaging with the notch 15c of the switching sleeve 15, thereby preventing the switching sleeve 15 from moving proximal after injection. The needle cover sleeve 3 is locked in its most distal position by the arm 1a of the syringe holder 1, which extends radially into the recess 3b of the needle cover sleeve 3, thereby preventing the needle cover sleeve 3 from moving proximal after injection.

[0049] The end cap 12 is fixed to the housing 2 in the axial and rotational directions. The end cap 12 may be snap-fitted to the housing 2, bonded, or welded. The end cap 12 can be the closing cap of the autosyringer, forming the proximal boundary of the device's mechanical components when no further modules are to be added to the autosyringer. The end cap may provide projections, ribs, or 3D structures that act as shock absorbers. Preferably, the end cap 12 provides a platform or adapter for adding additional modules to the autosyringer. Preferably, this is an electronic module 16, which is closed by a closing cap 17 that engages with the end cap 12 and / or housing 2 of the autosyringer. The closing cap 17 may provide projections, ribs, or 3D structures on its outer surface that act as shock absorbers. Preferably, the module is a removable module that can be removed and separated from the autosyringer after injection. The electronic module 16 may include a sensor or switch 16a and a battery 16b, as well as a printed circuit board 16c. The printed circuit board 16c may include a microprocessor, a transmitter / receiver unit, an antenna, and / or a light source such as an LED. The light source may be used to inform the user of the status of the device, e.g., "ready to use" or "injection complete." The sensor 16a may be part of the PCB 16c and is configured to detect whether the signal element 11 is in its most proximal position. The sensor 16a may be a switch located on the PCB 16c that detects whether the signal element 11 is in its most proximal position before injection, and / or after injection, and / or whether there is contact with the sensor at injection. The signal element 11 may have a projection extending in the proximal direction and optionally be guided through a passage in the end cap 12 to contact the sensor 16a. Alternatively, the signal element 11 may indirectly contact the sensor 16a via, for example, a pivot element, a rotating element, or an element that is part of or coupled to the end cap 12 and moves along the pen axis 18.The microprocessor can detect signals from sensor 16a and transmit injection data (e.g., time, duration, failure) to an external device using a communication module, for example, including a transmitter and / or receiver.

[0050] Therefore, the signal element 11 or its extension can directly or indirectly contact the sensor 16a before injection, when the signal element is in its most proximal position. During injection, the signal element is driven distally by the piston rod 7, and the signal element 11 or its extension cannot contact the sensor 16a. At the end of injection, the signal element 11 moves proximal and can again contact the sensor 16b. Each event may be recorded, transmitted to an external device, or an electronic module may generate a visual or acoustic signal.

[0051] Figures 3a and 3b show details of a prior art electronic module 16, which includes an independent switch 16a on a printed circuit board 16c. The electronic module is positioned between an end cap 12 and a closing cap 17. The electronic module includes a battery 16b connected to the PCB. The closing cap 17 includes an opening 17a closed by a transparent plug 25, allowing an LED light source 24 on the PCB to provide a light signal to the user. The plug 25 may include an elastic arm 25a surrounding the hole in the plug for guiding the LED light. The elastic arm 25a can also provide elastic force to the surface of the PCB to mechanically secure the PCB or to compensate for manufacturing tolerances. The electronic module 16 is attached to the proximal end of the auto-syringe by a mechanical interface, for example, a bayonet connection between the closing cap 17 and the housing 2, or between the closing cap 17 and the end cap 12. The housing 2 encloses an injection mechanism driven by an injection spring 9, which can act on a signal element 11 and / or a retaining element 6 at different stages of injection. In the embodiments shown in Figures 3a and 3b, the signal element 11 is configured to abut against the distal end of the detection pin 18 (Figure 3a). During injection, the signal element 11 moves distally, activating the switch 16a (Figure 3b). The detection pin in this embodiment moves along the longitudinal axis of the auto-injector, but may be tilted or pivotal with respect to the longitudinal axis L. Activation of the switch 16a can record the start or end of an injection, or initiate a post-injection holding time. The prior art electronic module shown in Figures 3a and 3b occupies space on the PCB, including a separate switch 16a, and is also part of the auto-injector, with a separate detection pin surrounded by the auto-injector being used.

[0052] Figure 4a shows an electronic module according to the present invention. The electronic module is surrounded by a closing cap 17 attached to the housing 2 or the end cap 12 of an automatic syringe. A PCB 16c is located at the proximal end of the extension 12a and guide sleeve 12b. A battery 16b is secured to the PCB by a battery holder 26 that contacts the terminals 16d, 16e of the battery 16b. One of the battery holders 26, in this example, the battery holder that contacts the negative terminal 16e, includes a battery contact extension 27. The battery contact extension 27 and the battery holder 26 for the negative terminal are made as a single unit from a pressed metal sheet. The battery contact extension 27 includes a portion oriented substantially parallel to the battery terminal and a portion oriented substantially perpendicular to the battery terminal. A bend 27b is located between the parallel and perpendicular portions. The portion of the battery contact extension oriented perpendicular to the battery terminal provides a sensing pin 27c, and the portion parallel to the terminal provides a leaf spring 27a. The PCB includes a passage 16f for the detection pin 27c. The distal end 27d of the detection pin 27c is guided by a guide sleeve 12b through a passage 12c in the end cap 12 toward the signal element 11 of the auto-syringe. Before the auto-syringe is put into use, the signal element 11 contacts the distal end 27d of the detection pin, pushing the detection pin 27c proximal against the biasing force provided by the leaf spring 27a, thereby creating a switching gap between the battery contact extension 27 and the PCB 16c, opening the switch, which will be discussed in more detail below.

[0053] The electronic module shown in Figure 4a is shown in Figure 4b when an automatic syringe is in use. During dose delivery, the signal element 11 is driven distally by the injection spring. The distal end 27d of the detection pin 27c moves distally due to the biasing force provided by the leaf spring 27a. The battery contact extension 27 contacts a contact that is part of the electronic circuit 29 located on the PCB 16c, thereby closing the switch.

[0054] Comparing Figures 3a and 4a, the effect of replacing the conventional switch 16a with the battery contact extension 27 and electrical contact 28 of this disclosure can be seen. Fewer components are needed to start the module by activating the switch. In addition, the space occupied by the switch 16a in Figure 3a can be used for a larger battery with a higher capacity in Figure 4a.

[0055] Figure 5a shows a perspective view of the electronic module 16 without a cover cap. The battery holder 26 contacts the positive terminal 16d (top surface of the battery), and the extension 26a is connected to the PCB 16c to provide mechanical support to the battery holder 26 and / or electrical contact to the electronic circuit 29 of the PCB. The extension 26a also extends from the battery holder and contacts the negative terminal (bottom surface of the battery). In the embodiment shown in Figure 5a, two extensions 26a extend from the battery holder 26 to provide mechanical support to the battery and / or electrical contact to the electronic circuit 29 of the PCB. A battery contact extension 27 is located between the two extensions 26a of the battery holder and contacts the negative terminal or bottom surface of the battery. Figure 5a shows the automatic syringe before use, where the battery contact extension 27 is moved proximal against the biasing force of the leaf spring, and as a result the battery contact extension 27 is not in contact with the electrically operated contact 28 which is part of the electronic circuit 29, for example the switch (27, 28) is open. Figure 5b shows the automatic syringe in use, where the switch (27, 28) is closed.

[0056] Figure 6a shows a side view of the electronic module with the switch open, and Figure 6b shows a side view of the electronic module with the switch closed. Two battery holders 26, each having an extension 26a, position and hold the battery 16b on top of the PCB 16c. The battery contact extension 27 extends from the negative terminal 16e of the battery. The bent portion 27b of the battery contact extension is located between the leaf spring 27a and the detection pin 27c. The PCB 16c includes a passage 16f for the detection pin 27c, the distal end 27d of which is configured to engage with the drive element of the auto-injector, thereby pushing the battery contact extension 27 proximal against the biasing force of the leaf spring. In Figure 6a, the battery contact extension 27 is not in contact with the electrically operated contact 28 (the switch is open), and in Figure 6b, the switch is closed.

[0057] A partial bottom perspective view of the electronic module is shown in Figures 7a and 7b, with further details shown in Figures 8a and 8b. The battery contact extension 27 is made from a pressed metal sheet and has a detection pin 27c formed as a narrow extension adjacent to the bent portion 27b, so that a lateral extension 27e is left on one side of the passage 16f as the detection pin 27c is guided through the passage 16f of the PCB. The tip portion 27f hangs from the lateral extension 27e (details shown in Figure 8a). The electrical operating contacts 28 of the PCB surround the passage 16f and can contact the lateral extension 27e of the battery contact extension 27 to close the switches 27, 28. In Figures 7a and 8a, the switches are open because there is a switching gap 30 between the battery contact extension 27 and the electrical operating contacts 28. In Figures 7b and 8b, the switch is closed, and the lateral extension 27e of the battery contact extension 27 is in contact with the electrical operating contact 28. Optionally, the electrical operating contact may cover at least a portion of the surface of the passage 16f itself. The electrical operating contact in the passage 28a is configured to contact the tip section 27f. The tip section can remove deposits or corrosion products from the surfaces of the contacts 28, 28a as the switch moves from the open state (Figure 8a) to the closed state (Figure 8b). [Explanation of Symbols]

[0058] 1 Syringe holder 1a Arm 2 Housing 3-needle cover sleeve 3a Proximal end 3b recess 4 Pen caps 5 Mechanic Holder 5c retaining spring 6 Retention elements 6a Center pin, guide pin 6b Arm 6c protrusion 6d proximal end 7 Piston rod 7a recess 7b recess 8 Locking sleeve 8a Flexible arm 9. Injection spring 9a Distal end 9b Proximal end 10 Needle cover sleeve spring 10a Distal end 10b Proximal end 11 Signal Elements 11a protrusion 11b Arm 11c protrusion 12 End caps 12a Projection / Rim 12b Guide Sleeve 12c aisle end cap 14-needle shield remover 15 Switching Sleeves 15a Distal end 15b rim 15c notch 16 Electronic Modules 16a Conventional Sensors / Switches 16b Battery 16c printed circuit board, PCB 16d Battery terminal (+) 16e Battery terminal (-) 16f passage PCB 17 Closing cap 17a aperture 18 pivot elements, detection pins 19 stopper 20 auto-injector 21 Pre-filled syringes 21a Proximal end 22-needle shield 23 Hollow needle 24 LED 25 transparent plugs 25a Wing 26 Battery holder 26a Extension 27 Battery contact extension 27a Leaf spring 27b Bend part 27c detection pin 27d distal end 27e Lateral extension 27f Front details 28 Electrical contact PCB 28a Electrical contact passage 29 Electronic circuit PCB 30 Switching gap L Longitudinal axis 8, 15 Switching Modules 27, 28 Switch

Claims

1. An electronic module configured for a drug delivery device (20), - A printed circuit board (16c) having an electronic circuit (29), - Battery (16b), - A switch element for operating the electronic module (16) and In an electronic module comprising, the switch element is - An electrically operated contact (28) that provides connection to the aforementioned electronic circuit (29), - Battery contact extension (27) extending from the terminals (16d, 16e) of the battery (16b) and Equipped with, The battery contact extension (27) is biased toward the electrical operating contact (28) to close the switching gap (30) between the battery contact extension (27) and the electrical operating contact (28). An electronic module characterized in that the operating elements (11, 6) are configured to engage with the operating elements (11, 6) of the drug delivery device (20) such that the operating elements (11, 6) press the battery contact extension (27) against the biasing force and maintain the switch element in an open state.

2. An electronic module according to claim 1, wherein the battery contact extension (27) comprises a spring element (27a) that biases the battery contact extension (27) toward the electrical operating contact (28).

3. An electronic module according to claim 2, wherein the battery contact extension (27) comprises a detection pin (27c), and the spring element (27a) is positioned between the terminals (16d, 16e) of the battery (16b) and the detection pin (27c).

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

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

6. An electronic module according to claim 5, wherein the spring member is a leaf spring (27a), the detection pin (27c) is oriented substantially perpendicular to the leaf spring (27a), and a bent portion (27b) is formed between the leaf spring (27a) and the detection pin (27c).

7. An electronic module according to any one of claims 4 to 6, wherein the electrical contact (28) at least partially surrounds the passage (16f) of the printed circuit board (16c).

8. An electronic module according to claim 7, wherein the detection pin (27c) is configured to pass at least partially through the passage (16f) and the distal end (27d) of the detection pin (27c) engages with the actuation elements (11, 6) of the drug delivery device (20).

9. An electronic module according to claim 8, wherein the electrical contact (28) at least partially covers the inner surface of the passage (16f).

10. An electronic module according to claim 9, wherein the battery contact extension (27) comprises a lateral extension (27e) and a tip section (27f) for contacting the electrically operated contacts (28, 28a), and the lateral extension (27e) has an outer dimension larger than the inner dimension of the passage (16f).

11. An electronic module according to any one of claims 1 to 10, wherein when the drug delivery device is in use, the engagement between the actuation element (11, 6) and the battery contact extension (27) is released when the actuation element (11, 6) of the drug delivery device moves axially along the longitudinal axis of the drug delivery device (20), or tilts with respect to the longitudinal axis of the drug delivery device (20), or rotates around the longitudinal axis of the drug delivery device (20), thereby closing the switching gap (30).

12. An electronic module according to any one of claims 1 to 11, further comprising a mechanical interface configured to be detachably attached to the drug delivery device (20).

13. An electronic module according to claim 12, wherein the detection pin (27c) is part of the mechanical interface or is located on the mechanical interface.

14. A drug delivery device comprising an electronic module according to any one of claims 1 to 13, wherein the electronic module is detachably attached to the drug delivery device (20) or incorporated into the drug delivery device (20).

15. A drug delivery device according to claim 14, wherein the drug delivery device (20) is a spring-driven automatic syringe, and the injection spring (9) moves the drive element (7) distally, rotates the actuation elements (11, 6), tilts the actuation elements (11, 6), or moves the actuation elements (11, 6) axially in the distal direction to release the engagement between the battery contact extension (27) and the actuation elements (11, 6).

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