Improved reservoir unit for a drug delivery device

Abstract

A disposable reservoir unit (1) for a drug delivery device (50), the disposable reservoir unit being detachably connectable to a drive unit (51) of the drug delivery device (50), the reservoir unit (1) comprising: a holder (2) for an insertable prefilled reservoir (3); a cap assembly (4) axially movable relative to the holder (2) or relative to the prefilled reservoir (3); a sensor assembly (5) wirelessly activatable for read and write operations, wherein the sensor assembly (5) comprises a wireless tag (21) and a temperature sensor (6) thermally couplable to the prefilled reservoir (3), and wherein the sensor assembly (5) is integrable in one or both of the holder (2) or the cap assembly (4) by a dedicated accommodation cavity (8) adapted to form-fit at least a portion of an outer shape (7) of the sensor assembly (5).

Description

Technical Field

[0001] This invention relates to a drug delivery device or drug administration device for injecting, transporting, administering, injecting, or dispensing substances and / or liquids, such as insulin, hormone preparations, or vaccines. The drug delivery device or drug administration device is separate from an injection device and includes a reusable drive unit and a disposable reservoir unit configured for releasable attachment to the drive unit. Background Technology

[0002] A wide variety of diseases require routine treatment with medication administered subcutaneously, and numerous drug delivery devices have been developed to support accurate and controlled delivery of specific amounts of medication to patients during self-administration. Delivery devices include injection devices that are removed from the injection site after each medication event or drug delivery process, and infusion devices with cannulas or needles that remain in place in the patient's skin for an extended period.

[0003] For example, with the aid of multivariable dosing insulin pens, diabetes can be treated by self-administering insulin or its derivatives. Pen devices typically have an elongated body that defines the device's longitudinal axis. Autopilots have a motor or drive spring for biasing the plunger rod and displacing the piston within the container; the drive spring may need to be manually charged or strained before the dose is injected. Manually powered delivery drives require the user to manually provide energy to move the piston, for example, by applying a distal force component to the injection device.

[0004] Typically, the dosage of medication to be injected can be manually selected by turning the dosage knob and observing the actual dial dose from the dosage window or display of the insulin pen. Dosage is dispensed by inserting the needle into the appropriate part of the skin and manually moving the piston or pressing the release button on the auto-injection device. Auto-injection devices may include an electronic dosage dial mechanism to automatically set the dosage.

[0005] The use of autoinjectors with a syringe is also known. An autoinjector typically includes a body for housing the syringe and a drive mechanism to move the plunger of the syringe when the autoinjector is actuated. The drive mechanism typically includes a drive source, such as a motor or a strong spring, for moving a transmission element, such as a lever, acting on the plunger of the syringe.

[0006] For safety and hygiene reasons, it is desirable that the needle not protrude from the housing of the autoinjector except when the needle is being used to inject medication. Therefore, either the autoinjector removes the needle from the housing for injection and returns it to the housing after injection; or the housing provides a needle guard that can be moved to expose the needle for injection and can be returned to its needle-covered position after injection.

[0007] Most autoinjectors are configured as single-use devices, integrating the syringe and drive mechanism into a single housing. For hygiene reasons, such devices are typically disposable.

[0008] Disposable autoinjectors, including those with electric actuators or electronic controllers, require a power source, typically in the form of batteries. However, in such cases, the autoinjector should not be disposed of as conventional waste but must undergo special handling or recycling, which is an additional burden on the patient. Furthermore, disposing of the battery, motor, and / or electronics after a single use is wasteful of resources and increases the cost of the autoinjector.

[0009] To meet the need for handling and disposing of drug delivery device components in different ways, semi-reusable devices have been developed. These devices typically include a reusable drive unit and a disposable syringe, cartridge, or reservoir unit, which is releasably coupled to the drive unit. The drive unit usually includes an actuation mechanism and electronics, while the reservoir unit includes a syringe with a needle and a sleeve covering the needle. Therefore, the user can discard the reservoir unit when it is empty or after use, and can load a new reservoir unit into the drive unit for an upcoming injection.

[0010] Drug delivery devices in the prior art may include a temperature measurement system and / or an identification system, such that a unit of the device can process drug information received from a tag sensor of the identification system and determine the drug temperature in the reservoir based on the processed information.

[0011] WO16140853 A1 discloses various devices including a transponder for determining characteristics of a dose delivery device. The transponder may include a first sensor configured to detect a first parameter of the dose delivery device based on movement of at least one of the dose delivery device or a drug contained within the dose delivery device, wherein the first sensor is configured to generate a first signal indicating the first parameter. The transponder may include a processor operatively coupled to the first sensor and configured to process the first signal. The transponder may include an indicator unit operatively coupled to the processor and configured to generate an output based on the first signal, wherein the output is perceptible to a user. The transponder may also include a battery configured to power at least one of the first sensor, the processor, and the indicator unit.

[0012] WO16033507 A2 discloses a system for a pharmaceutical delivery device, comprising a temperature control system and an identification system. The temperature control system includes a heater, one or more temperature sensors, and a control unit, configured to identify and control the temperature of a cartridge containing a pharmaceutical product. The identification system includes a control unit and a label sensor electrically coupled to the control unit, configured to identify a cartridge containing a pharmaceutical product, wherein the label sensor is activated upon detecting the presence of the cartridge. The pharmaceutical delivery device includes both the temperature control system and the identification system, such that the control unit of the device can process pharmaceutical information received from the label sensor of the identification system, and determine and control the temperature of the pharmaceutical product within the cartridge based on at least a portion of the processed information.

[0013] WO16115372 A1 discloses an intelligent module configured to work with a syringe device. The intelligent module may include electronics, such as sensors and indicators, and is programmed to detect environmental parameters. If the sensors detect parameters outside predetermined boundaries or ranges, the indicator can be activated to notify the user that the syringe device may be unsafe for drug administration. Summary of the Invention

[0014] The object of this invention is to improve the safety of the reservoir unit or the drug delivery device including the reservoir unit during operation or use. Another object of this invention is to provide simplified manufacturing and assembly, as well as to reduce waste in automated drug delivery devices.

[0015] These objectives are achieved by the disposable reservoir unit or drug delivery device according to the independent claims. Variations of embodiments of the invention are apparent from the dependent claims and this specification.

[0016] This invention relates to a disposable reservoir unit for a drug delivery device, the reservoir unit being detachably connected to a disposable or reusable drive unit of the automated drug delivery device, the reservoir unit comprising: - A retainer for an insertable pre-filled reservoir; - A cap assembly that is axially movable relative to the retainer or relative to the pre-filled reservoir; - A sensor assembly, which is wirelessly activatable for read and write operations, wherein The sensor assembly includes a wireless tag and a temperature sensor, the temperature sensor being thermally coupled to the pre-filled reservoir, and wherein the sensor assembly can be integrated into one or both of the retainer or the cap assembly via a dedicated receiving cavity adapted to positively fit at least a portion of the external shape of the sensor assembly. For example, the dedicated receiving cavity can be formed into a box, groove, drilled hole, blind hole, or pocket with shape-fit, locking, or snap-fit ​​capabilities.

[0017] In a variant embodiment of the invention, the final assembled reservoir unit does not include the sensor assembly in the accommodating cavity.

[0018] The intended use, preservation, and compliant administration of modern pharmaceuticals require certain physical or chemical parameters of the drug to be within a defined range. Temperature is crucial for most parameters, such as viscosity, activity, dispersibility, or absorbability. Using the dedicated containment cavity according to the invention, sensor assemblies can be precisely and reliably placed near the drug volume.

[0019] In addition, the disposable reservoir unit can be assembled or used without the sensor assembly being inserted into the receiving cavity, reducing the amount of operation and tooling required in the production process, making it suitable for cost-sensitive platform variants or environmentally friendly applications.

[0020] A disposable reservoir unit is part of a semi-disposable or semi-reusable drug delivery device. Therefore, the reservoir unit is inoperable without a reusable drive unit for the drug delivery device. To prepare a drug delivery device for drug delivery purposes, the user must attach or connect the reservoir unit to a drive unit. The drive unit may include a drive mechanism adapted to dispense liquid medicine from a reservoir held within the reservoir unit once the reservoir unit is attached to the drive unit.

[0021] The drug delivery device can be manual or automatic, such as an autoinjector, auto-injector, or auto-pen. Automatic devices typically include an automatic drive mechanism, such as an elastic element (e.g., a pre-tensioned spring), or an electric motor to drive the dispensing assembly to dispense liquid medication from a reservoir, such as a pre-filled syringe or pre-filled vial, both of which provide a barrel containing the medication and a movable stopper as the dispensing assembly. Manual injection devices include a manual actuator, such as a dispensing button or plunger, which must be pressed by the user to move the dispensing assembly in the dispensing direction.

[0022] The cap assembly or needle cap is movable along a longitudinal axis and guided by a reservoir retainer or holder. The cap assembly can be implemented as a shield or sleeve, or as a sleeve-shaped element adapted to cover or enclose the needle of a pre-filled syringe or the needle hub and diaphragm of a pre-filled syringe mounted inside the reservoir retainer. The movement of the needle cap allows switching between a safe state and an injection state, in which the needle or needle hub is covered and the needle is not protruding from the device housing; in the injection state, the needle is not covered and is exposed or protruding from the housing.

[0023] In one embodiment, the cap assembly is the outermost part of the disposable reservoir unit, forming part of the device housing. This means that the reservoir unit does not include any outer housing or enclosure, but only includes the removable cap assembly. This provides a simple design. In an alternative embodiment, a label is affixed to the cap assembly.

[0024] The retainer, cap assembly, and cap can be plastic parts. The term "separate" means that the parts can operate independently of each other prior to assembly and can be manufactured separately and independently from other parts. This does not preclude these parts from being connected once the reservoir unit is assembled. These parts can be connected to each other, for example, by snap-fit ​​or threaded and / or linear guide structures.

[0025] In this application, the terms “substance,” “pharmaceutical,” “drug,” and “pharmaceutical preparation” should be understood to include any flowable medical formulation suitable for controlled administration via a device, such as a cannula or hollow needle, and to include liquids, solutions, gels, or microsuspensions containing one or more medically active ingredients. A drug can be a composition containing a single active ingredient, or a premixed or co-formulated composition having more than one active ingredient present in a single container. Pharmaceutical preparations include drugs, such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing drugs or derivatives or similar preparations), proteins and hormones, active ingredients derived from or harvested from biological sources, hormone- or gene-based active ingredients, nutritional formulations, enzymes, and other substances in solid (suspension) or liquid form, as well as polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or antibody portions, and suitable basic, auxiliary, and carrier substances.

[0026] The term "distal" refers to the direction or end of a drug delivery device that carries the injection needle or cannula, while the term "proximal" refers to the opposite direction or end to the needle or cannula.

[0027] The term “injection system” or “injector” refers to a drug delivery device that is removed from the injection site after each drug event or drug delivery process, while the term “infusion system” refers to a device with a cannula or needle that remains in the patient’s skin for an extended period of time (e.g., several hours).

[0028] In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude multiple. For example, "an arm" does not exclude the fact that there may be two arms that functionally or structurally fulfill the purpose of an "arm." The fact that certain elements or steps are described in different claims should not exclude the existence of other meaningful combinations of such elements or steps.

[0029] The sensor assembly can be integrally constructed with a flat or cylindrical substrate or base, for example as a printed circuit with an adhesive film or as an integrated circuit encapsulated in a glass or resin body (e.g., a cylindrical glass body or epoxy resin body with, for example, a circular cross-section and spherical ends).

[0030] For example, in high-volume production or in pre-production batches of platform variants, the substrate or base allows for the cost-effective, accurate, and loss-proof placement of sensor assemblies within the housing. Furthermore, the package or base protects the circuitry from damage or environmental influences.

[0031] The wireless tag is integrated into the sensor assembly, or the wireless tag is separate from the rest of the sensor assembly and connected via wiring.

[0032] These arrangements allow for optimized thermal coupling of the temperature sensor relative to the reservoir body, as well as optimized radio frequency exposure of the wireless tag.

[0033] The sensor assembly is integrated with a dedicated housing cavity by means of shape fitting only and / or by one or more of the following processes: adhesive process, welding process (e.g., welding between or under one or more protective layers), press-fitting, clamping, snapping, or overmolding.

[0034] This enables captive integration of sensor components, combined with defined thermal conductivity and anti-detachment assembly steps.

[0035] A receiving cavity adapted to the external shape of the sensor assembly ensures partial integration and positioning of the sensor assembly within or on the reservoir unit. The receiving cavity and / or the external shape includes one or more of the following on or in one or more of the retainer (2), the cover assembly (4), or the sensor assembly (5): a depression, notch, recess, pin, cam, surface, rib, drill hole, slot, or clamp. The external shape of the sensor assembly may, for example, be complementary to the internal shape of the receiving cavity.

[0036] These mutually compatible constructions allow for precise placement and orientation relative to the reservoir's cylinder during the assembly and use of the sensor assembly.

[0037] The integration of the sensor assembly into one or both of the retainer or cap assembly can be performed before, during, or after the assembly of the reservoir unit.

[0038] These alternatives enable streamlined assembly steps and facilitate monitoring of the assembly process. Due to the captive integration fit of the sensor assembly within the accommodating cavity, the sensor assembly is securely positioned within unassembled or pre-assembled components (e.g., retainers or cover assemblies).

[0039] Thermal coupling between the temperature sensor and the inserted reservoir can be improved by creating elastic contact pressure and / or gapless contact between the retainer or cap assembly and the surface of the reservoir around the cavity.

[0040] It can achieve shorter measurement delay and better anti-interference ability for measuring temperature values.

[0041] Alternatively or additionally, the thermal coupling between the temperature sensor and the retainer or cap assembly or the inserted reservoir can be enhanced by filling the gap formed between and around the accommodating cavity and the external shape of the sensor assembly with thermally conductive paste, or by using a thermally conductive film or molded body, or by adding thermally conductive additives to the injection-molded plastic.

[0042] It can achieve shorter measurement delay and better anti-interference ability for measured temperature values.

[0043] In a preferred embodiment of the reservoir unit, the cap assembly is a sleeve. The retainer is then concentrically arranged within the sleeve. Therefore, if the cap assembly is not obstructed or held in the covered position, it can be movable along the longitudinal axis, outside the retainer, and relative to the retainer. The reservoir unit may also include a cap and / or label or a pre-filled reservoir.

[0044] The form of the sleeve allows for a compact design.

[0045] In one embodiment, thermal coupling between the temperature sensor and the inserted reservoir occurs at or inside the axial portion of the pre-filled reservoir containing the drug.

[0046] It can achieve shorter measurement delay and better anti-interference ability for measured temperature values.

[0047] In one embodiment, the insertable or insertable pre-filled reservoir includes a cannula (e.g., a stabilized needle) or a permeable diaphragm (e.g., a permeable diaphragm held by a crimped collar) with a non-removable connection at the distal portion.

[0048] In addition, insertable or pre-filled reservoirs include releasably tight-closed sleeves (e.g., rigid needle guards "RNS" at the distal portion) that completely enclose the distal portion or cannula.

[0049] In embodiments of the reservoir unit, the sensor components can be wirelessly activated, written to, or read from by the read / write unit.

[0050] The present invention also relates to a drug delivery device comprising a reservoir unit (e.g., the disposable reservoir unit described above) and a drive unit (e.g., a reusable drive unit). The latter may include a plunger rod and an actuator for moving the plunger rod along a dispensing direction to dispense a drug from a reservoir, such as a syringe including a stopper (e.g., a rubber stopper). The reservoir unit may be releasably attached to the drive unit.

[0051] As mentioned above, the drug delivery device can be a manual injection device that requires user force to drive the plunger rod to dispense medication, or alternatively, the injection device can be an automated injection device including an automatic actuator, such as a biased spring assembly or an electric motor. The drug delivery device can be a semi-reusable (or semi-disposable) auto-injector. The automatic actuator may include an electric motor adapted to drive the plunger rod to dispense medication from a syringe.

[0052] The drive unit of the drug delivery device may also include a read / write unit. Additionally or alternatively, an external device, such as a remote control, accessory, or smartphone, may include a read / write unit. The drive unit may include a controller, a display, and buttons.

[0053] In one embodiment, the cap assembly can be locked to a retainer in the covered position, and the cap assembly can be unlocked by relative movement between the reservoir unit and the drive unit. The reservoir unit can be moved manually by a user or automatically by an automatic actuator of the drive unit.

[0054] The scope of this invention includes the use of the reservoir unit of the above-described variations according to embodiments of the invention in the construction of a drug delivery device. The invention may also include the use of pre-filled reservoirs and / or drive units and / or caps in the construction of a drug delivery device. Attached Figure Description

[0055] In the following, the subject matter of the invention will be explained in more detail with reference to the preferred exemplary embodiments shown in the accompanying drawings, wherein: Figure 1 An exploded perspective view of a first embodiment of a disposable liquid reservoir unit according to the present invention is depicted; Figure 2a Depicting Figure 1 The proximal view and lateral view of the disposable reservoir unit in the image. Figure 2b Depicting Figure 2a Cross-sectional view (CC) of the disposable reservoir unit in the middle; Figure 2c Depicting Figure 2a A cross-sectional view (DD) of the disposable reservoir unit in the middle; Figure 3 An exploded perspective view depicting a second embodiment of a disposable reservoir unit having a sensor assembly is shown. Figure 4a Depicting Figure 3 A side view of the disposable liquid reservoir unit in its pre-assembled state; Figure 4b Depicting Figure 3 A perspective view of the disposable liquid reservoir unit in its pre-assembled state; Figure 5a Depicting Figure 3 Near-side view, side view and sectional view (KK) of the disposable liquid reservoir unit in the middle; Figure 5b Depicting Figure 5a A cross-sectional view of the disposable liquid reservoir unit (JJ); Figure 5c Depicting Figure 5a A cross-sectional view (LL) of the disposable reservoir unit in the middle has a accommodating cavity and a sensor unit; Figure 6 An exploded perspective view depicting components of another embodiment of the disposable reservoir unit shows alternative mounting locations for the sensor assembly; Figure 7a A perspective view of a drug delivery device with external components is depicted; Figure 7b Depicting Figure 7a A partial cross-sectional perspective view of the drug delivery device.

[0056] The reference numerals used in the accompanying drawings and their main meanings are listed in summary form in the list of drawings. In principle, the same parts or equivalent functional units in the drawings are given the same reference numerals. Detailed Implementation

[0057] In this instruction manual, the term "distal" refers to the side where the injection needle is located. This is located on the side where the needle is positioned. Figures 1 to 7b The left side of the figure. The term "proximal" refers to the opposite side or rear end of the device, and is located on the right side of the figure. The structural features and components of the reservoir unit 1 and the drug delivery device 50 according to the invention will be described exemplarily below. Subsequently, the function of the semi-reusable drug delivery device 50 will be explained.

[0058] Figure 1 A perspective view of a first embodiment of the disposable reservoir unit 1 is shown. A retainer 2 is adapted to coaxially hold the reservoir in the form of a pre-filled syringe 3 and the needle sleeve 16 in the form of a rigid needle sheath. A sensor assembly 5 is integrally constructed with a substrate or base, and includes an integrated circuit protected within a cylindrical glass body having a circular cross-section and a spherical cap. A cap assembly 4 is adapted to coaxially receive and axially guide the retainer 2 and the reservoir 3, respectively. The cap 13 is detachable from the distal end of the cap assembly 4 and is adapted to remove the needle sleeve.

[0059] exist Figure 2aThe near-side view shows Figure 1 The reservoir unit 1 is pre-filled. The reservoir 3 is inserted into the retainer 2 and the cap assembly 4. Figure 2a The side view shows the reservoir unit 1, with its cap 13 attached to the distal end of the cap assembly 4.

[0060] Figure 2b As shown Figure 2a The CC section view is marked in the center. It shows a pre-filled reservoir 3 having a distal portion 15 and a cannula 14 fixed therein. The reservoir 3 is assembled in a retainer 2. The cap assembly 4 is held axially movable on the retainer 2.

[0061] Figure 2c As shown Figure 2a The diagram shows a cross-sectional view of DD (marked in center). It illustrates a pre-filled reservoir 3 containing the drug 12 within it. A receiving cavity 8 is formed in the retainer 2 in the form of a blind hole or a bag. The receiving cavity 8 abuts the outer surface 10 of the reservoir 3. A sensor assembly 5 (which has an external shape 7) is embedded in the receiving cavity 8 within a glass body 22 and is thus thermally coupled tightly to the drug 12 in the pre-filled reservoir 3. The sensor assembly 5 houses circuitry within it, including a wireless tag 21 and a temperature sensor 6.

[0062] Figure 3 A perspective view of a second embodiment of the disposable reservoir unit 1 is depicted. A retainer 2 is adapted to coaxially hold the reservoir, which is in the form of a pre-filled syringe 3 having a needle sleeve 16 in the form of a rigid needle sheath. A sensor assembly 5 is integrally constructed with a substrate or base, and includes an integrated circuit protected within a cylindrical glass body having a circular cross-section and a spherical cap. A cap assembly 4 is adapted to coaxially receive and axially guide the retainer 2 and the reservoir 3, respectively. The cap 13 is removable from the distal end of the cap assembly 4 and adapted to remove the needle sleeve.

[0063] exist Figure 4a The side view shows the pre-assembled state. Figure 3 The reservoir unit 1 is located in the middle, with a cap 13 attached to the distal end of the cap assembly 4, and a retainer 2 coaxially inserted into the cap assembly 4 in the middle position. A sensor assembly 5 is inserted into a receiving cavity 8. The receiving cavity 8 has the shape of a box or groove, which is molded by or in the wall of the retainer 2.

[0064] exist Figure 4b The perspective view shows Figure 4aThe reservoir unit 1 is in a pre-assembled state, with a cap 13 attached to the distal end of a cover assembly 4, and a retainer 2 coaxially inserted into the cover assembly 4 in a central position. A sensor assembly 5 is inserted into a receiving cavity 8. The receiving cavity 8 has the shape of a box or groove molded by or in the wall of the retainer 2.

[0065] exist Figure 5a The near-side view shows Figure 3 The reservoir unit 1 is pre-filled. The reservoir 3 is inserted into the retainer 2 and the cap assembly 4. Figure 5a The side view shows the reservoir unit 1, with the cap 13 attached to the distal end of the cover assembly 4. The pre-filled reservoir 3 can be seen through a window in the cover assembly 4. Figure 5a In the KK cross-sectional view, the sensor assembly 5 is held in the accommodating cavity 8. The accommodating cavity 8 is thermally coupled to the surface 10 of the syringe 3, wherein the syringe contains the drug 12.

[0066] Figure 5b As shown Figure 5a The JJ cross-sectional view is marked in the middle. It shows a pre-filled reservoir 3 containing the inserted drug 12 and a needle sleeve 16 hermetically mounted on the distal portion 15 of the pre-filled reservoir 3. The needle sleeve 16 is operatively coupled to a cap 13, which is attached to a cap assembly 4. The pre-filled reservoir 3 is coaxially held within a retainer 2.

[0067] Figure 5c As shown Figure 5a The LL cross-sectional view is marked in the middle. It shows the cap assembly 4 with the cap 13 attached and the retainer 2 with the pre-filled reservoir 3 inserted. In the retainer 2, the receiving cavity 8 can be seen having sensor assemblies 5 that are inserted or captured respectively. The sensor assembly 5 includes a wireless tag 21 (e.g., RFID circuitry) and a temperature sensor 6 mounted on a substrate 9 (e.g., a printed circuit board). This arrangement is sealed in a glass body 22 having an external shape 7.

[0068] Figure 6 An exploded perspective view depicting other embodiments or examples of the reservoir unit 1 is shown. It exemplarily illustrates an option where the sensor assembly 5 is formed as a rectangular substrate attached to a suitable receiving cavity 8 (e.g., a notch for the cap 13, cover assembly 4, retainer 2, outer label 20, and reservoir unit 3).

[0069] Figure 7aAn autoinjector 50 in an assembled state is depicted, having a reservoir unit 1 attached to a drive unit 51. The reservoir unit 1 is inserted, thereby causing a position sensor to detect movement, and a controller 54 in an electronic module to detect the presence of the reservoir unit 1 within the drive unit 51. A wireless code reader (not shown) within the drive unit 51 reads an RFID code and the temperature of the reservoir unit 1. Subsequently, the controller 54 of the drive unit 51 can send the drug information read from the code and / or the measured temperature value to an external device 18 for verification of the drug or agent using predefined information. Alternatively, the controller 54 in the drive unit 51 can compare the drug information read from the code with predefined information stored in a memory within the drive unit 51. In a variant, a read / write unit 17 located in an external device 18, such as a smartphone, can directly perform read / write operations on the sensor assembly 5 in the reservoir unit 1.

[0070] In the event of successful drug validation, controller 54 receives an enable signal (either from external device 18 or from an internal comparison). Controller 54 then controls the electric motor to rotate the threaded rod, causing the trigger sleeve in drive unit 51 to move a short distance of a few millimeters in the proximal direction and locking reservoir unit 1 in drive unit 51.

[0071] The controller 54 displays the locked or unlocked status to the user, for example, on the external device 18 or on the LED 52 on the drive unit 51 of the autoinjector 50.

[0072] In this state, cap 13 remains mounted on the distal end of cap assembly 4. The next step is decapping, which can be initiated by pressing button 53. Then, controller 54 drives the motor to move reservoir unit 1 back and forth. Thus, cap 13 is removed. Alternatively, the proximal movement of the trigger sleeve in drive unit 51 releases the cap lock of reservoir unit 1, meaning that cap 13 is no longer locked to reservoir unit 1, and the user can manually remove cap 13.

[0073] The auto-injector 50 is now decapped and ready for injection. The controller 54 displays a corresponding notification on the display 52 and / or the external device 18.

[0074] As a next step, the user places the distal end of the cap assembly 4 at the injection site and pushes the autoinjector 50 toward the injection site. This causes the cap assembly 4 to move from the distal coverage position to the proximal position into the drive unithousing (push against the skin). This further movement is detected by a position sensor, which triggers the controller 54 in the electronic module to initiate the injection. This means that the controller 54 drives the electric motor along the dispensing direction, and thus rotates the threaded rod, thereby moving the plunger rod distally. The distal flange of the plunger rod causes the piston inside the prefilled reservoir 3 to move distally, and thus dispenses the liquid medication, allowing it to pass through the cannula 14 and exit from the prefilled reservoir 3.

[0075] The controller 54 displays the hold time, indicating the period during which the user must hold the autoinjector 50 on the injection side after injection to ensure complete drug delivery and absorption. The controller 54 may display a decrementing count, informing the user of the remaining hold time. Once the hold time has elapsed, a notification is displayed to the user that the autoinjector can be removed from the injection site. Alternatively, the end of the hold time may be indicated solely by an LED.

[0076] When the user removes the autoinjector 50 from the injection site, the cap assembly 4 moves distally back to the needle-covering position.

[0077] Furthermore, the user can pull out the entire reservoir unit 1 from the drive unit 51. The user can now discard and / or recycle the reservoir unit 1, and the drive unit 3 is ready to be loaded with a new reservoir unit 1.

[0078] Figure 7b Depicting Figure 7a The automatic injector 50 is shown in a partial perspective cross-section in its locked state, and the injector 50 has a cap 13. The reservoir unit 1 is inserted, and the markers 5, 6, 21, and 8 point to the area of ​​the housing portion of the drive unit 51 covering the sensor assembly 5, temperature sensor 6, wireless tag 21, and accommodating cavity 8. Next to the controller 54 (which has internal components including buttons 53 and a display 52), the read / write unit 17 can be seen.

[0079] Although the invention has been described in detail in the accompanying drawings and the foregoing description, such description should be considered illustrative or exemplary, and not restrictive. Those skilled in the art, in practicing the claimed invention, will understand and implement various variations of the disclosed embodiments by studying the drawings, this disclosure, and the appended claims.

[0080] List of reference numerals 1 Liquid Storage Unit 2 retainers 3 Pre-filled reservoirs 4-Cover Components 5 sensor components 6 temperature sensors 7External shape 8 accommodating cavities 9 substrates 10 surfaces 11 Axial Section 12 doses 13 hats 15. Distal portion 16 Needle sleeve 17 Reading and Writing Unit 18 External devices 20 tags 21 wireless tags 22 Glass body 23. Diaphragm 50 Drug delivery device 51 drive unit 52 monitors 53 buttons 54 controllers

Claims

1. A disposable reservoir unit (1) for a drug delivery device (50), the disposable reservoir unit being detachably connected to a drive unit (51) of the drug delivery device (50), the reservoir unit (1) comprising: - Retainer (2), the retainer being for insertable pre-filled reservoir (3); - A cap assembly (4), which is axially movable relative to the retainer (2) or relative to the pre-filled reservoir (3); - Sensor assembly (5), which is wirelessly activatable for read and write operations. Its features are, The sensor assembly (5) includes a wireless tag (21) and a temperature sensor (6) thermally coupled to the prefilled reservoir (3), and wherein the sensor assembly (5) is integrated into one or both of the retainer (2) or the cap assembly (4) via a dedicated receiving cavity (8) adapted to mate with at least a portion of the external shape (7) of the sensor assembly (5), wherein the sensor assembly (5) includes printed circuitry within a cylindrical glass body (22).

2. The disposable reservoir unit (1) according to claim 1, wherein the disposable reservoir unit does not have a bias spring assembly or electric motor for dispensing liquid from the pre-filled reservoir (3).

3. The disposable reservoir unit (1) according to claim 1 or 2, wherein the wireless tag (21) is integrated into the sensor assembly (5), or the wireless tag (21) is separate from the rest of the sensor assembly (5) and connected by wiring.

4. The disposable reservoir unit (1) according to any one of claims 1 to 3, wherein the sensor assembly (5) is integrated in the dedicated receiving cavity (8) by form fitting only and / or by one or more of adhesive processes, welding processes, press fitting, clamping, snap-fitting or overmolding.

5. The disposable reservoir unit (1) according to any one of claims 2 to 4, wherein the receiving cavity (8) ensures the partial integration and positioning of the sensor assembly (5) in or on the reservoir unit (1), the receiving cavity (8) being adapted to the external shape (7) of the sensor assembly (5), the receiving cavity (8) and / or the external shape (7) comprising one or more of the recesses, grooves, pins, cams, surfaces, ribs, drill holes, slots, and clamps on or in one or more of the retainer (2), the cap assembly (4) or the sensor assembly (5).

6. The disposable reservoir unit (1) according to any one of claims 1 to 5, wherein the integration of the sensor assembly (5) may be performed prior to assembling the reservoir unit (1).

7. The disposable reservoir unit (1) according to any one of claims 1 to 6, wherein the temperature sensor (6) is thermally coupled to the inserted reservoir (3) by contact pressure and / or gapless contact through the elastic action of the retainer (2) or the cap assembly (4) around the receiving cavity (8) with the surface (10) of the reservoir (3).

8. The disposable reservoir unit (1) according to any one of claims 1 to 7, wherein the thermal coupling of the temperature sensor (6) is enhanced by thermally conductive paste, film, molding body or by thermally conductive additives in injection molding material.

9. The disposable reservoir unit (1) according to any one of claims 1 to 8, wherein the reservoir unit (1) further comprises an inserted reservoir (3) and a cap (13).

10. The disposable reservoir unit (1) according to claim 9, wherein the thermal coupling between the temperature sensor (6) and the inserted reservoir (3) occurs at the axial portion (11) of the pre-filled reservoir (3) containing the agent (12).

11. The disposable reservoir unit (1) according to claim 9 or 10, wherein the inserted reservoir (3) includes a non-detachably connected cannula (14) or a permeable diaphragm (23) at the distal portion (15).

12. The disposable reservoir unit (1) according to any one of claims 9 to 11, wherein the inserted reservoir (3) includes a releasably tightly closed sleeve (16) at the distal portion (15) that completely surrounds the distal portion (15) or the cannula (14).

13. The disposable reservoir unit (1) according to any one of claims 1 to 12, wherein the sensor assembly (5) can be wirelessly activated, written to or read out by the read / write unit (17).

14. The disposable reservoir unit (1) according to claim 13, wherein the drive unit (51) of the drug delivery device (50) includes the read / write unit (17), and / or wherein an external device (18), such as a remote control, an accessory device or a smartphone, includes the read / write unit (17).

15. Use of the disposable reservoir unit (1) according to any one of claims 1 to 14 in constructing a drug delivery device (50).

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