Monitoring system and method for injection devices

Abstract

A monitoring system and associated methods for an infusion device or simulated infusion device are disclosed. The monitoring system may include a force sensor configured to output a force signal when a user applies force to a plunger to operate the infusion device or simulated infusion device to perform or simulate a drug infusion; an infusion completion sensor configured to output an infusion completion signal when the user moves the plunger from an initial position to a final position relative to the drug container during operation of the infusion device or simulated infusion device; and a torque sensor configured to output a torque signal. The monitoring system may further include a computing unit configured to determine one or more parameters related to the user's preparation and / or operation of the infusion device or simulated infusion device from any one or a combination of the force signal, the infusion completion signal, and the torque signal.

Description

Technical Field

[0001] Cross - reference to Related Applications Priority is claimed to U.S. Provisional Patent Application No. 63 / 526,906, filed Jul. 14, 2023, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to injection devices, and more particularly to monitoring various parameters related to preparing and operating an injection device for drug delivery.

Background Art

[0003] Often, to prepare and operate an injection device, such as a syringe, for drug delivery, a user needs to manually handle, manipulate, configure, position, connect, disconnect, and / or interact with various components of the injection device. As an example, a user may need to twist off a protective cap covering a dispensing element before using a syringe for injection. As another example, a user may need to push a plunger through the barrel of a syringe to expel a drug contained within the barrel of the syringe.

[0004] In situations where users are at least partially responsible for manually preparing or operating the infusion device, it may be beneficial, or even essential, to consider various human factors and ergonomic considerations in the device design. These considerations may include ensuring that an acceptable proportion of the target user population or the general population possesses the physical strength, stamina, and / or dexterity necessary to safely and effectively prepare and operate the infusion device. Furthermore, in some cases, design choices that can improve the usefulness of the infusion device may not coincide with, or even conflict with, operational needs, such as sealing requirements to ensure drug sterility and the forces required, which are determined by the drug viscosity characteristics. Therefore, incorporating human factors and ergonomic considerations into the design of an infusion device can be a challenging endeavor.

[0005] To address one or more of the needs and challenges described herein and other related needs and challenges, this disclosure describes advantageous monitoring systems and methods for injection devices. [Overview of the Initiative] [Means for solving the problem]

[0006] One aspect of the present disclosure provides a monitoring system for an infusion device or a simulated infusion device. The infusion device or simulated infusion device may include a drug container and a plunger at least partially located within the drug container. The monitoring system may include a force sensor configured to output a force signal when a user applies force to the plunger in order to operate the infusion device or simulated infusion device to perform or simulate a drug infusion. The monitoring system may further include a computing unit configured to determine, from at least the force signal, at least one parameter relating to the user's operation of the infusion device or simulated infusion device.

[0007] Another aspect of the present disclosure provides a method for monitoring the operation of an infusion device or a simulated infusion device. The infusion device may include a drug container and a plunger at least partially located within the drug container. The method may include receiving a force signal from or via a force sensor when a user applies force to the plunger to operate the infusion device or simulated infusion device to perform or simulate a drug infusion, and determining at least one parameter related to the user's operation of the infusion device or simulated infusion device from at least the force signal.

[0008] Further aspects of the present disclosure provide a system comprising an infusion device or a simulated infusion device. The infusion device or simulated infusion device may include a drug container and a plunger at least partially positioned within the drug container. The plunger may be movable relative to the drug container from an initial position to a final position during operation of the infusion device or simulated infusion device. The system may further include a force sensor connected to the plunger and configured to output a force signal when a user applies force to the plunger to operate the infusion device or simulated infusion device to perform or simulate a drug infusion. Furthermore, the system may include an infusion completion sensor connected to the drug container and configured to output an infusion completion signal when the plunger is in its final position.

[0009] Further aspects of the present disclosure include a simulated injection device comprising a drug container and a plunger at least partially disposed within the drug container, wherein the plunger is coupled to the drug container (e.g., fixedly coupled) so that the plunger does not move relative to the container when a user applies force to the plunger to simulate drug injection. The system may further include a force sensor coupled to the plunger and configured to output a force signal when a user applies force to the plunger to simulate drug injection.

[0010] Another aspect of the present disclosure provides a monitoring system for a removable cap of an injection device. The monitoring system may include a simulated portion of the injection device configured to connect the removable cap to the monitoring system. Furthermore, the monitoring system may include a torque sensor configured to output a torque signal when the removable cap is rotated or attempted to be rotated in order to remove the removable cap from the simulated portion of the injection device.

[0011] Further aspects of the present disclosure provide a method for monitoring a removable cap connected to a simulated portion of an injection device. The method may include receiving a torque signal from or via a torque sensor when a user rotates or attempts to rotate the removable cap in order to remove it from the simulated portion of the injection device, and / or determining from at least the torque signal at least one parameter related to the user's removal or attempt to remove the removable cap from the simulated portion of the injection device.

[0012] Further embodiments of the present disclosure provide a plunger for a drug delivery device. The plunger may include a distal end and a proximal end. The distal end of the plunger may be configured to be at least partially located within the drug container of the drug delivery device. The proximal end of the plunger may include a pressing surface configured to facilitate the application of distally directed force to the plunger during operation of the drug delivery device. The proximal end of the plunger may further include a non-slip member extending proximally from the pressing surface and configured to facilitate the measurement of the length of the plunger between the pressing surface and another part of the plunger, such as a portion of the distal end of the plunger.

[0013] This disclosure is intended to be better understood from the following description in conjunction with the accompanying drawings. Some of the drawings have been simplified by omitting selected elements for the purpose of more clearly illustrating other elements. Such omissions of elements in some of the drawings do not indicate the presence or absence of any particular element in any of the exemplary embodiments, unless explicitly stated in the corresponding description. Furthermore, none of the drawings are necessarily drawn to a constant scale. [Brief explanation of the drawing]

[0014] [Figure 1] This is a perspective view of an exemplary injection device in various embodiments. [Figure 2] Exemplary monitoring systems for injection devices are shown according to various embodiments. [Figure 3] This document illustrates another exemplary monitoring system for an injection device, according to various embodiments. [Figure 4] Another diagram of an exemplary monitoring system for the injection device shown in Figure 3 is shown. [Figure 5] This document illustrates another exemplary monitoring system for an injection device, according to various embodiments. [Figure 6] Exemplary monitoring systems for simulated portions of injection devices are shown according to various embodiments. [Figure 7] An exemplary monitoring system for the simulated portion of the injection device shown in Figure 6, as used by the user, is shown. [Figure 8] Figure 6 shows a graph of the torque-time profile output by an exemplary monitoring system for a simulated portion of the injection device. [Figure 9] Another exemplary monitoring system for a simulated injection device, according to various embodiments, is shown. [Figure 10] Figure 9 shows a cross-sectional view of the simulated injection device along the longitudinal axis A. [Figure 11]Another exemplary monitoring system for a simulated injection device, according to various embodiments, is shown. [Figure 12] Figure 11 shows a cross-sectional view of the drug container of the simulated injection device, viewed along the longitudinal axis A. [Figure 13] Another exemplary monitoring system for a simulated injection device, according to various embodiments, is shown. [Figure 14] An exemplary side view of a plunger for a drug delivery device according to various embodiments is shown. [Figure 15] Figure 14 shows a cross-sectional view of the plunger along its major axis B. [Figure 16] Figure 14 shows a top view of the proximal end of the plunger. [Modes for carrying out the invention]

[0015] The present disclosure generally relates to systems and methods for monitoring one or more parameters associated with a user who must prepare and / or operate an injection device (e.g., a drug delivery device) for the purpose of, for example, administering or delivering a drug to a patient. The injection device can take various forms, including but not limited to syringes such as standard syringes, prefilled syringes, luer lock syringes, safety syringes, and similar variations. The user can be any individual, including, for example, a medical professional such as a physician or nurse, or a layperson such as a patient. Embodiments of the monitoring systems and methods disclosed herein can facilitate tests, including, for example, clinical trials, that are performed to evaluate the safety, effectiveness, efficacy, ergonomics, etc. of the injection device or a portion thereof. For example, the monitoring systems and methods of the present disclosure can be useful for evaluating whether the design, manufacture, and / or intended use of the injection device meets various human factors and / or regulatory requirements and / or standards, including, for example, limitations on the amount and / or duration of force and / or torque that a user may need to apply to the injection device when preparing or operating the injection device for drug delivery. Further, by utilizing one or more sensors and a computing unit to identify one or more parameters associated with the preparation or operation of the injection device by a user, the systems and methods of the present disclosure can provide reliable empirical information for guiding the development and / or use of the injection device. Additionally, the embodiments disclosed herein can be configured to monitor and measure parameters related to not only active functional injection devices, but also simulated or dummy injection devices that may or may not be capable of administering a drug to a patient and / or that are designed to facilitate various test and / or training arrangements and / or purposes.

[0016] To provide background for various embodiments of the monitoring system and method described further below, reference is made to FIG. 1 to describe a non-limiting example of an injection device 10 that may be used or configured to simulate a monitoring system and method. This example of the injection device 10 generally takes the form of a syringe, but it should be noted that the monitoring system and method of the present disclosure are not limited to syringes and may be applied to other injection devices, including, for example, any injection device that requires at least some manual intervention or action on the user side for preparation and / or operation.

[0017] Referring to FIG. 1, the injection device 10 can be configured to deliver a drug, sometimes referred to herein as a medicament or pharmaceutical product, into, for example, a patient's subcutaneous tissue, ocular tissue, or other tissue or simulated tissue. The drug can be various biological agents, including but not limited to peptides, peptibodies, and / or antibodies. The drug can be in a fluid or fluid form, gelatin form, and / or powder form, but the present disclosure is not limited to a particular form or state of the drug. The injection device 10 shown in FIG. 1 can be in its final assembled form and / or pre-delivery or storage state.

[0018] The injection device 10 can include a drug container 12 (shown as transparent in FIG. 1), a plunger 14, a stopper 16, a needle 18, and a flange extender 20. The drug container 12 can have a longitudinal axis A and a proximal end 12a and a distal end 12b disposed along the longitudinal axis A. The drug container 12 can include a barrel 24 having a generally cylindrical wall 26 that partially or entirely defines an internal bore or reservoir 28. At least the wall 26 of the barrel 24 can be made of a rigid or semi-rigid material, including, for example, glass, plastic (e.g., polypropylene), and / or any other suitable material or combination of materials. At least a portion or the entire barrel 24 can have a generally circular or any other suitable cross-sectional shape (e.g., in a plane perpendicular to the longitudinal axis A).

[0019] In its stored state, the drug container 12 may be partially or completely filled with the drug, or it may be empty. In some embodiments, the drug container 12 may be pre-filled with the drug by, for example, the manufacturer and / or other supplier, and shipped to the point of care ready or substantially ready for user operation. In some such embodiments, the infusion device 10 may take the form of a pre-filled syringe. In other embodiments, the infusion device 10 may be provided to the user empty, and the user may be required to fill the drug container 12 by transferring the drug from a vial or other external drug storage container into the drug container 10 immediately or substantially immediately before operating the infusion device 10 to perform an infusion, for example, at the point of care.

[0020] In some embodiments, the volume of drug placed in the drug container 12 of the infusion device 10 is equal to 0.5 mL, or approximately (e.g., ±10%) equal to 0.5 mL, or equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.25 mL, or approximately (e.g., ±10%) equal to 2.25 mL, or equal to 3 mL, or approximately (e.g., ±10%) equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 1 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) It may be 3 mL or less, or approximately (e.g., ±10%) 4 mL or less, or approximately (e.g., ±10%) less than 5 mL, or approximately (e.g., ±10%) 10 mL or less, or approximately (e.g., ±10%) within the range of 0.5 to 10 mL, or approximately (e.g., ±10%) within the range of 0.5 to 5 mL, or approximately (e.g., ±10%) within the range of 0.5 to 4 mL, or approximately (e.g., ±10%) within the range of 0.5 to 3 mL, or approximately (e.g., ±10%) within the range of 0.5 to 2.25 mL.

[0021] The proximal end 12a of the drug container 12 may include a proximal axial opening 27 through which the plunger rod 14 extends. The distal end 12b of the drug container 12 may include a distal axial opening 30 configured to provide fluid communication with the drug in the reservoir 28 of the drug container 12. In some embodiments, the needle 18 may be fixedly connected to the distal end 12b of the drug container 12 and / or to the reservoir 28 via the distal axial opening 30. The proximal end 18a of the needle 18 may be bonded to, crimped to, or otherwise firmly mechanically connected to the wall 26 of the barrel 24, or integrally formed with the wall 26, so that the needle 18 cannot move relative to the wall 26 of the barrel 24. The distal end 18b of the needle 18 may include a sharp tip or other sharp shape that allows the distal end 18b of the needle 18 to pierce and / or penetrate the patient's skin, subcutaneous tissue, eye tissue, and / or other tissues. The needle 18 may be hollow and / or include an axial passage parallel to and / or coaxial with the longitudinal axis A of the drug container 12. One or more openings may be formed at the distal end 18b of the needle 18 to allow the drug to flow out of the needle 18 into the patient's body during operation of the infusion device 10. The needle 18 may be made of metal, plastic, and / or any other preferably rigid material. The distal end 18b of the needle 18 may be covered with a removable sterile barrier (not shown in Figure 1), such as a rigid needle shield (RNS) or a non-rigid needle shield (nRNS), before use. The removable sterile barrier may be configured to protect the needle 18 from contaminants in the external or surrounding environment before operation of the infusion device 10. The user may need to remove the removable sterile barrier from the needle 18 before operating the infusion device 10 to perform drug infusion. In alternative embodiments, the needle 18 may be omitted or, at the very least, not be connected to the drug container 12 from the outset. In such alternative embodiments, the distal end 12b of the drug container 12 may be connected to, and / or form, a nozzle or other fluid path member, including, for example, a male or female Luer lock fitting.

[0022] The proximal end 12a of the drug container 12 may include a flange 34, which in some embodiments may correspond to a barrel flange. The flange 34 may be integrally formed with the wall 26 of the barrel 24 so that the flange 34 and the wall 26 define a single, integrated structure, or alternatively, the flange 34 and the wall 26 of the barrel 24 may be separate structures that are rigidly connected to each other. The flange 34 may extend generally radially outward with respect to the longitudinal axis A of the barrel 24. The flange 34 may extend all or partially around the barrel 24. In some embodiments, two or more separate barrel flanges may extend radially outward from each portion of the wall 26 of the barrel 24. In some embodiments, the flange 34 may be configured to prevent the injection device 10 from rolling unintentionally on a flat surface when placed sideways.

[0023] The stopper 16 can be movably positioned within the barrel 24 of the drug container 12 so as to be able to move at least distally along the longitudinal axis A from an initial position near the proximal end 12a of the drug container 12 to at least an end-of-injection position near the distal end 12b of the drug container 12. In at least some embodiments, proximal movement of the stopper 16 along the longitudinal axis A may also be possible. The stopper 16 can be constructed of an elastomer material such as rubber, or any other suitable material. The stopper 16 can be slidably and / or in a sealed contact with the inner surface of the barrel wall 26 of the barrel 24 so as to prevent or stop the drug in the reservoir 28 from leaking beyond the stopper 16 when the stopper 16 moves distally. As an example, the stopper 16 may form a fluid seal with the inner surface of the barrel wall 26 of the barrel 24. By moving the stopper 16 distally, the drug can be pushed from the reservoir 28 into the needle 18 and discharged through the needle 18.

[0024] The plunger 14 can extend through the opening 26 at the proximal end 12a of the drug container 12 such that the distal end 14b of the plunger 14 is at least partially located inside the drug container 12 and the proximal end 14a of the plunger 14 is at least partially located outside the drug container 12. The distal end 14b of the plunger 14 can be connected to the proximal end of the stopper 16. In some embodiments, this connection can be achieved by one or more threaded surfaces. Generally, the plunger 14 can be configured to allow the user to manually or semi-manually move the stopper 16 distally and / or proximally along the longitudinal axis A. As an example, the plunger 14 may have a longitudinal axis parallel to and / or coaxial with the longitudinal axis A of the drug container 12. As a more specific example, the proximal end 14a of the plunger 14 may include a thumb rest 40, which in some embodiments corresponds to the plunger flange, and allows the user to press their thumb against the proximal surface 40a of the thumb rest 40 to push the plunger 14, and thereby the stopper 16, distally along the longitudinal axis A, thereby discharging the drug from the reservoir 28 through the needle 18 into, for example, the patient's tissue. The thumb rest 40 may also include a distal surface 40b, which can be used to detect and determine the completion state of the injection device 10, as will be described later.

[0025] In embodiments where the drug container 12 is provided to the user empty and the user needs to draw the drug from a vial or other external drug storage container into the reservoir 28 of the drug container 12, the user can pull the thumb rest 40 proximal, thereby moving the stopper 16 proximal along the longitudinal axis A. This action can create a vacuum that allows the drug to be drawn into the reservoir 28, for example, via a needle 18. As shown in Figure 1, the thumb rest 40 can be configured as a flange of the plunger 14 that extends radially outward with respect to the portion immediately adjacent to the thumb rest 40.

[0026] Continuing to refer to Figure 1, the flange extender 20 can be connected to the flange 34 of the drug container 12. The flange extender 20 may be an accessory or add-on component that is initially separate from the infusion device 10 and then connected to the flange 34 before operating the infusion device 10 to deliver the drug to the patient. For example, the user of the infusion device 10 may be responsible for connecting the flange extender 20 to the flange 34 of the drug container 12 before operation. In alternative embodiments, the flange extender 20 may be omitted.

[0027] The flange extender 20 can be configured to facilitate the user's gripping of the drug container 12 during, for example, operation of the infusion device 10 for delivering drugs to a patient. Generally, the flange extender 20 serves to extend the radial length of the flange 34 of the drug container 12, thereby increasing the surface area available for the user to press one or more of their other fingers against, for example, the proximal end 14a of the plunger 14 while the user presses their thumb against the proximal end 14a of the plunger 14. As an example, the user can press their index and / or middle fingers against the flange extender 20 to apply one or more proximal forces to the flange extender 20, while simultaneously pressing their thumb of the same hand against the thumb rest 40 of the plunger 14 to apply a distal force to the plunger 14. In some embodiments, the user may press one or more of their other fingers (instead of or in addition to their thumb) against the thumb rest 40 to apply a distal force to the plunger 14. In some such embodiments, to grip the flange extender 20, the user may use one or more of their thumb and / or other fingers that are not pressing on the thumb rest 40.

[0028] At least a portion of the flange extender 20, when connected to the drug container 12, can extend generally radially outward with respect to the longitudinal axis A of the barrel 24. The flange 34 can extend all or partially around the barrel 24.

[0029] Furthermore, the flange extender 20 may include one or more generally distally facing surfaces 20a and 20b that come into contact with one or more of the user's fingers during operation of the infusion device 10 for administering a drug. For example, the user can press one or more of their fingers against the distally facing surfaces 20a and 20b of the flange extender 20, thereby applying a generally proximal force to the distally facing outer surfaces 20a and 20b of the flange extender 20 during operation of the infusion device 10 for administering a drug. Generally, the distally facing outer surfaces 20a and 20b of the flange extender 20 can be configured such that the functional structure of the force applied to the flange extender 20 by the user facilitates the efficient conversion of the force from the plunger rod 14 into the movement of the stopper 16 (for example, the movement of the stopper 16 distally along the longitudinal axis A) to expel the drug from the infusion device 10. As an example, the distal outer surfaces 20a and 20b of the flange extender 20 may be configured to prevent or block the user's fingers from sliding radially and / or axially, thereby maintaining the fingers in their respective mechanically desired positions (e.g., a desired radial distance measured from the longitudinal axis A). Furthermore or alternatively, the distal outer surfaces 20a and 20b of the flange extender 20 may be configured to apply a repulsive force to the user's fingers in a mechanically desired direction (e.g., parallel to or substantially parallel to the longitudinal axis A). To facilitate the efficient conversion of the force applied by the user into the movement of the stopper 16, the flange extender 20 can reduce or minimize force loss and / or make it easier and / or less cumbersome for the user to operate the injection device 10 compared to a conventional syringe.

[0030] According to at least some embodiments, operating the infusion device 10 to inject a drug may include a user (which may be a patient) first removing the RNS or other protective element (if any) covering the needle 18, inserting the distal end of the needle 18 into the patient's tissue at the desired injection site, pushing the plunger 14 distally to discharge the desired amount or all of the drug in the drug container 12 through the needle 18 into the patient's tissue, removing the needle 18 from the injection site, and, if the infusion device 10 is intended for single use, placing the infusion device 10, for example, in a Sharps container. In some embodiments, pushing the plunger 14 distally to discharge the drug from the infusion device 10 may involve moving the plunger 14 relative to the drug container 12 from an initial position, as shown in Figure 1, where the distal surface 40b of the thumb rest 40 is separated from the proximal surface 20c of the flange extender 20 by a first axial distance, to a final position where the distal surface 40b of the thumb rest 40 is separated from the proximal surface 20c of the flange extender 20 by a second axial distance less than the first axial distance. In some embodiments, the distal surface 40b of the thumb rest 40 may be in contact with or positioned immediately adjacent to the proximal surface 20c of the flange extender 20 at the final position, such that the second axial distance is zero or a few millimeters. When the plunger 14 is in its final position, in some embodiments this may correspond to the end of the infusion state of the infusion device 10, where all or substantially all of the drug, or the intended amount or dose of the drug, has been discharged from the infusion device 10.

[0031] Figure 2 shows one embodiment of a monitoring system 50 for an infusion device, including, for example, an infusion device 10 and / or a simulated version thereof. The monitoring system 50 can generally be configured to detect, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical characteristics, conditions, states, and / or properties) relating to the infusion device, including, for example, the operation of the infusion device or simulated infusion device by a user to perform or simulate drug infusion. Thus, this embodiment of the monitoring system 50 may include a force sensor 52, an infusion completion sensor 54, and a computing unit 56. In other embodiments, the monitoring system 50 may omit one or more of the force sensor 52, the infusion completion sensor 54, and the computing unit 56, and / or include additional sensors and / or computing units. In some embodiments, the computing unit 56 may be omitted.

[0032] The force sensor 52 may be any device that detects or detects the amount of force or load applied to and / or received by the force sensor 52 and / or structures connected to the force sensor 52. In some embodiments, the force sensor 52 may include load cells (e.g., compression load cells, miniature compression load cells, and / or any other suitable load cells), strain gauges, pressure transducers, and / or any other devices configured to convert mechanical forces into electrical signals and / or other computer-readable signals. The force sensor 52 may be configured to output, for example, an electrical signal or other computer-readable signal (also referred to herein as a “force signal”) representing the magnitude of the applied force when a force is applied to the plunger 14, including a distally directed force applied by a user to move or attempt to move the plunger 14 distally during injection or simulated injection. The force sensor 52 may be configured to output this signal to the computing unit 56 over the duration of the applied force so that the computing unit 56 can monitor and analyze the variation (or absence of variation) in the magnitude of the applied force over time.

[0033] In some embodiments, the force sensor 52 may be connected to the plunger 14 (e.g., directly connected) so that the force sensor 52 can measure the force applied to the plunger 14, or at least the distal and / or proximal force applied to the plunger 14 in a direction parallel or substantially parallel to the longitudinal axis A. In some such embodiments, the force sensor 52 may be positioned and / or bonded to the proximal outer surface of the plunger 14, for example, including the proximal surface 40a of the thumb rest 40, as shown in Figure 1, so that the force sensor 52 can be axially positioned between the user's thumb and the thumb rest 40 when the user operates the infusion device 10 or a simulated version thereof to perform or simulate drug infusion. As a result, when the user operates the infusion device 10 or a simulated version thereof to perform or simulate drug infusion, the user's thumb can directly contact the force sensor 52 or the housing housing the force sensor 52. By having the user's thumb directly contact the force sensor 52 or position it immediately adjacent to the force sensor 52, the accuracy and / or reliability of the force sensor 52 in detecting the force applied by the user can be improved, at least in some cases.

[0034] In some embodiments, the sensor 52 may be positioned partially or completely within the plunger 14 instead of being positioned on the outer surface of the plunger 14. In some such embodiments, the sensor 52 may be positioned within the proximal end 14a or the distal end 14b of the plunger 14. Furthermore, in some embodiments, the force sensor 52 may be connected to the stopper 16 (e.g., directly) instead of, or in addition to, the plunger 14.

[0035] The injection completion sensor 54 may be any device that detects or indicates that the plunger 14 is in a position corresponding to the injection completion state of the injection device 10. In some embodiments, the injection completion sensor 54 may be configured to detect that the plunger 14 is in the final position after it has been moved from the initial position to the final position by the user. As described above, when the plunger 14 is in the final position, the distal surface 40b of the thumb rest 40 may be in contact with or immediately adjacent to the proximal surface 20c of the flange extender 20.

[0036] In some embodiments, the injection completion sensor 54 may include a touch sensor (e.g., a piezoelectric touch sensor, a capacitive touch sensor, a resistive touch sensor, and / or any other suitable touch sensor), a proximity sensor (e.g., a Hall effect proximity sensor, a photoelectric proximity sensor, and / or any other suitable proximity sensor), and / or any other device configured to convert physical contact or proximity of two or more objects into an electrical signal and / or other computer-readable signal. The injection completion sensor 54 may be configured to output an electrical signal or other computer-readable signal (also referred to herein as the “injection completion signal”) indicating that the plunger 14 is in the final position when the user operates the injection device 10 or the simulated injection device to perform or simulate an injection and moves the plunger 14 from its initial position to its final position. In some embodiments, the signal output by the injection completion sensor 54 may not indicate the progress of the plunger 14 as it moves from the initial position to the final position, but only indicate that the plunger 14 is in the final position (when that happens). In other embodiments, the signal output by the injection completion sensor 54 may indicate the progress of the plunger 14 as it moves from the initial position to the final position.

[0037] In some embodiments, the injection end sensor 54 may be connected (e.g., directly connected) to any other part of the injection device 10 that contacts or is immediately adjacent to the flange extender 20, the proximal end 12a of the drug container 12 (including the flange 34), and / or to a portion of the plunger 14 when the plunger 14 is in its final position rather than its initial position. In some embodiments, as shown in Figure 2, the injection end sensor 54 may be positioned on and / or bonded to the proximal surface 20c of the flange extender 20. Furthermore, in some embodiments, the injection end sensor 54 may be aligned with at least a portion of the thumb rest 40 of the plunger 14 such that at least a portion of the thumb rest 40 contacts or is immediately adjacent to the injection end sensor 54 when the plunger 14 is in its final position. To achieve this positioning, the radial distance between the injection end sensor 54 and the longitudinal axis A may be less than or equal to the radial distance between the outermost radial portion of the thumb rest 40 and the longitudinal axis A. By the plunger 14 contacting or being immediately adjacent to the injection completion sensor 54, the injection completion sensor 54 can output an injection completion signal to at least the computing unit 56.

[0038] The computing unit 56 can generally be configured to receive signals output or transmitted from any one or combination of the force sensor 52, the injection completion sensor 54, other sensors, and other devices, and to process those signals (e.g., by analyzing, comparing, and evaluating them) to determine one or more parameters related to the user's preparation and / or operation of the injection device 10 or a simulated version thereof for, for example, performing or simulating a drug injection. The computing unit 56 can perform these functions in real time, or substantially in real time, for example, while the user is preparing and / or operating the injection device 10 or the simulated injection device to, for example, perform or simulate a drug injection.

[0039] In some embodiments, the computing unit 56 may take the form of a general-purpose or dedicated computer, or any other suitable computing device. Furthermore, in some embodiments, the computing unit 56 may be a programmable logic controller, a desktop computer, a laptop computer, a tablet computer, a smartphone, a server, or any combination thereof. The computing unit 56 may be a standalone device, or it may be integrated with the injection device 10, the force sensor 52, or the injection termination sensor 54, or it may be distributed across a plurality of these or other devices. In some embodiments, the computing unit 56 may be an electrical device (e.g., a hardwired circuit and / or circuit component), a combination of electrical devices, a mechanical device, a combination of mechanical devices, or a combination of mechanical and electrical devices. Furthermore, in some embodiments, the computing unit 56 may not include a physical processor or other physical components, and may be configured as a program module consisting of a set of non-temporary computer-readable instructions executed by the processor of the computer on which the program module is installed.

[0040] Referring to Figure 2, in some embodiments, the computing unit 56 may include at least one or any combination of a processor 60 (e.g., a microprocessor), a sensor interface 62, a program memory 64, a user interface 66, a network interface 68, a monitoring parameter memory 70, and a system bus that enables one or more of the elements of the computing unit 56 to communicate with one or more of the other elements of the computing unit 56.

[0041] The sensor interface 62 can be configured to communicate via wired and / or wireless (e.g., Bluetooth) communication with the force sensor 52, the injection completion sensor 54, and / or other sensors. In some embodiments, the sensor interface 62 may include an analog-to-digital converter configured to convert analog signals received from the force sensor 52, the injection completion sensor 54, and / or other sensors into digital signals for processing by the processor 60.

[0042] The program memory 64 may include, for example, a non-temporary computer-readable storage medium configured to store data, such data including, for example, non-temporary computer-readable instructions constituting one or more services or programs, and any data operated by or generated in such services or programs. The program memory 64 may store data on volatile memory (e.g., RAM) and / or non-volatile memory (e.g., hard disk), and may be removable or non-removable memory. The monitoring parameter memory 70 may be configured in a similar manner to the program memory 64, may be part of the program memory 64, or may be separate from it. In some embodiments, the monitoring parameter memory 70 may be implemented in local memory and / or remote memory according to any preferred data storage technique (e.g., as a relational database).

[0043] The processor 60 may be configured to fetch and execute instructions stored in program memory 64 to perform various functions of the methods disclosed herein, for example, including determining one or more parameters related to the preparation and / or operation of a user-injection device or simulated injection device for performing or simulating a drug injection, based on signals received from one or more of the sensors. In some embodiments, the computing unit 56 may include one or more processors in addition to the processor 60.

[0044] The user interface 66 may include at least one or any combination of a graphical display (e.g., an LED monitor, a touchscreen, etc.), an input unit (e.g., a keypad, a keyboard, buttons, knobs, etc.), lights, and speakers. In some embodiments, by executing instructions stored in the program memory 64, the processor 60 may be caused to display visual representations (e.g., graphs, charts, tables, text, infographics, symbols, colored and / or flashing lights, etc.) and / or sounds that indicate one or more parameters determined by the computing unit 56 related to the preparation and / or operation of the injection device 10 or simulated injection device by the user for, for example, to perform or simulate drug injection.

[0045] The network interface 68 may be configured to establish communication with external devices over a network (e.g., the Internet), and may include an antenna for wireless communication, a port for wired connections, a connection to a modem, a connection to a router (e.g., a wireless router), or any combination thereof.

[0046] In some embodiments, the monitoring system 50 may include an oscilloscope that is separate from or integrated with the computing unit 56. The oscilloscope may be coupled with a force sensor 52, an injection termination sensor 54, and / or other sensors, and may generate a real-time or substantially real-time display of the shape, amplitude, frequency, and / or other characteristics of the signals output by the sensors.

[0047] In some embodiments, the monitoring module 72 may be stored in the program memory 64 as a set of instructions executable on the processor 60 and / or other processors. The monitoring module 72 can receive and process, for example via the processor 60, one or more force signals output by the force sensor 52, an injection completion signal 54 output by the injection completion sensor 54, and / or other signals output from other sensors or devices to determine and / or generate data representing one or more parameters related to the preparation and / or operation of the injection device 10 or simulated injection device by the user for, for example, performing or simulating a drug injection. In some embodiments, the monitoring module 72 can generate graphs, charts, tables, infographics, symbols, text, and / or other visual representations of the data to be displayed via a screen or monitor included in the user interface 66. Furthermore, in some embodiments, the monitoring module 72 can store (e.g., record) the data it generates in the monitoring parameter memory 70.

[0048] One or more parameters determined by another element of the monitoring module 72 and / or computing unit 56 may include at least (a) the length of time required for the user to operate the infusion device 10 or simulated infusion device to complete or substantially complete drug infusion; (b) the force-time profile of the force applied to the plunger 14 of the infusion device 10 or simulated infusion device when the user is operating the infusion device 10 or simulated infusion device to perform or simulate drug infusion or simulated infusion; (c) the time when drug infusion begins; (d) the time when drug infusion is completed or substantially completed; and (e) any one or combination of the maximum, minimum, and / or average force applied to the plunger 14 of the infusion device 10 or simulated infusion device when the user is operating the infusion device 10 or simulated infusion device to perform or simulate drug infusion.

[0049] In some embodiments, the monitoring module 72 and / or other elements of the computing unit 56 may determine the length of time required for the user to operate the infusion device 10 or simulated infusion device to complete or substantially complete drug infusion by processing (e.g., analyzing, comparing, evaluating, etc.) both the force signal from the force sensor 52 and the infusion completion signal from the infusion completion sensor 54. In some such embodiments, this length of time may be determined by identifying when the force signal from the force sensor 52 exceeds a predetermined force level or threshold, identifying when the infusion completion signal is received from the infusion completion signal 54, and calculating the amount of time between these two events. In alternative embodiments, the monitoring module 72 and / or other elements of the computing unit 56 may determine the length of time required for the user to operate the infusion device 10 or simulated infusion device to complete or substantially complete drug infusion by analyzing only the force signal from the force sensor 52. In some embodiments, the length of time required for the user to operate the infusion device 10 or simulated infusion device may correspond to the length of time required for the user to move the plunger 14 from its initial position to its final position.

[0050] In some embodiments, the monitoring module 72 and / or other elements of the computing unit 56 may be configured to generate a graph plotting the force-time profile of the force applied to the plunger 14 of the infusion device 10 or simulated infusion device when the user operates the infusion device 10 or simulated infusion device to perform or simulate drug infusion. This graph may include force measured in Newtons (or another unit of measurement used to quantify force) on the vertical, i.e., "y" axis, and time in seconds (or another unit of measurement used to quantify time) on the horizontal, i.e., "x" axis. In some embodiments, the user interface 66 may display this graph on a screen or monitor.

[0051] In some embodiments, the monitoring module 72 and / or other elements of the computing unit 56 may determine the time when drug infusion begins by identifying when the force signal from the force sensor 52 exceeds a predetermined force level or threshold. In some embodiments, the monitoring module 72 and / or other elements of the computing unit 56 may determine the time when drug infusion begins without any input from any sensor other than the force sensor 52. In some embodiments, the time when drug infusion begins may correspond, for example, to the point when the plunger 14 begins to move distally relative to the drug container 12 as a result of the user applying a distal force to the plunger 14.

[0052] In some embodiments, the point at which drug injection is completed or substantially completed may correspond to the point at which the plunger 14 is in its final position, as indicated by or extrapolated from an injection completion signal from the injection completion sensor 54, receiving little or no force from the user, as indicated by or extrapolated from a force signal from the force sensor 52, and / or has stopped moving distally relative to the drug container 12, as indicated by or extrapolated from a force signal from the force sensor 52.

[0053] For example, monitoring a user's operation of the infusion device 10 or a simulated infusion device to perform or simulate drug infusion may include one or more of the following steps: As a preliminary step, unless already completed by the manufacturer or other entity or individual, the user may connect the force sensor 52 to the thumb rest 40 or another part of the plunger 14, connect the infusion end sensor 54 to the flange extender 20 and / or drug container 12, and / or connect the force sensor 52 and / or infusion end sensor 54 to the sensor interface 62 of the computing unit 56. Furthermore, as a preliminary step, if not yet completed by the manufacturer or other entity or individual, the user may fill the reservoir 28 of the drug container 12 with drug to a desired level. Next, the user inserts the distal end 18b of the needle 18 into the patient's tissue or simulated tissue and applies a distal force to the plunger 14, causing the plunger 14, and therefore the stopper 16, to also move distally from its initial position to its final position, thereby allowing the drug to be discharged from the drug container 12 through the needle 18 into the patient's tissue or simulated tissue. At least while the plunger 14 is moving from its initial position to its final position, the force sensor 52 can output a force signal, and the sensor interface 62 of the computing unit 56 can receive the force signal directly or indirectly from the force sensor 52. When the plunger 14 has moved to its final position, the injection completion sensor 54 can output an injection completion signal, and the sensor interface 62 of the computing unit 56 can receive the injection completion signal directly or indirectly from the injection completion sensor 54. Based on the analysis, comparison, evaluation, and / or other processing of any one or combination of force signals, injection completion signals, other sensor signals, and information pre-stored in the program memory 64, the monitoring module 72 of the computing unit 56 can determine any one or combination of the above-mentioned parameters and / or other data related to the user's operation of the injection device 10 or simulated injection device for performing or simulating drug injection.The determined one or more parameters and / or other data can be stored, for example, in the monitoring parameter memory 70. Furthermore, or alternatively, the program memory 64 and / or other elements of the computing unit 56 may generate one or more visual and / or audio displays of the one or more parameters and / or other data and output those displays, for example, through the user interface 66 of the computing unit 56 for consumption by the user and / or another individual.

[0054] While the aforementioned monitoring system 50 and related methods have been described in relation to monitoring the preparation and / or operation of the injection device 10 or a simulated version thereof, the monitoring system 50 and related methods can be used to monitor the preparation and / or operation of other injection devices and simulated versions thereof. Other such injection devices include, for example, Luer lock syringes, safety syringes, and similar variations, as well as simulated variations thereof.

[0055] Figures 3 and 4 show another embodiment of the injection device indicated by reference numeral 110, which can be prepared and / or operated by the user by the monitoring system 50 and associated methods described above. Various features of the injection device 110 in Figures 3 and 4 may be similar or identical in structure, configuration and / or function to the features of the injection device 10 described above in relation to Figures 1 and 2. Such features are assigned the same reference numerals as those used in Figures 1 and 2, except that they are increased by 100. Some descriptions of these features have been simplified or omitted for brevity.

[0056] The infusion device 110 generally takes the form of a Luer Lock syringe (also referred to as a Luer Lock syringe). Unlike the infusion device 10, the infusion device 110 does not necessarily have a needle connected to the distal end 112b of the drug container 112 when stored. Instead, the distal end 112b of the drug container 112 may have a Luer Lock connector member 180 that, when stored, is connected to a removable cap 182 and thereby partially or completely covered, as shown in Figure 2. In some embodiments, the removable cap 182 may be configured to protect the distal end 112 of the drug container by sealing engagement with the Luer Lock connector member 180, for example, to prevent or block the entry of contaminants into the drug container 112 via the Luer Lock connector member 180. Before performing the injection using the injection device 110, the user can remove the removable cap 182 from the Luer lock connector member 180 to expose the Luer lock connector member 180, and then connect a needle having a Luer lock hub (not shown) to the Luer lock connector member 180.

[0057] In some embodiments, the removable cap 182 may have a male fitting with a male thread, and the Luer lock connector member 180 may have a female fitting with a female thread configured to screw-engage with the female thread, or vice versa. The male thread of the male fitting screw-engage with the female thread of the female fitting so that, for example, a user of the injection device 110 can screw the removable cap 182 into / on the Luer lock connector member 180 and / or loosen / remove it from there. In some embodiments, the user can remove the removable cap 182 by rotating the removable cap 182 relative to the drug container 112 and / or by pulling the removable cap 182 proximal. In some embodiments, the axis of rotation of the removable cap 182 may be parallel to and / or coaxial with the longitudinal axis A of the drug container 112. In some embodiments, the removable cap 182 may include an internal sealing element having an inner surface that seals with the outer surface of the tip or cone formed by the distal end 112b of the drug container 112. Friction between this internal sealing element of the removable cap 182 and the tip or cone of the drug container 112, and / or friction between the threads of the male and female fittings of the removable cap 182 and the Luer lock connector member 180 can resist rotation of the removable cap 182 when a user attempts to loosen or otherwise remove the removable cap 182 from the drug container 112. In some embodiments, after removing the removable cap 182, the user can connect a needle with a Luer lock hub to the Luer lock connector member 180 by screwing the Luer lock hub onto (or into) the Luer lock connector member 180.

[0058] As shown in Figures 3 and 4, the force sensor 152 and / or injection completion sensor 154 can be connected to the injection device 110. The structure, configuration, and / or function of the force sensor 152 and injection completion sensor 154 may be the same as or identical to the force sensor 52 and injection completion sensor 54 described above in relation to the injection device 10, respectively. Furthermore, the force sensor 152 and injection completion sensor 154 can be connected to a monitoring system 50 or a similar system and output signals to it, which can then process those signals in the same or identical manner as described above with respect to processing the signals output by the force sensor 52 and injection completion sensor 54, respectively, in order to determine one or more parameters related to the user's operation of the injection device 110 or a simulated version thereof for performing or simulating drug injection.

[0059] Figure 5 shows one implementation of the injection device 110 in which an external clip 190 is used to connect the injection end sensor 154 to the flange extender 120. The external clip 190 facilitates positioning the injection end sensor 154 relative to the plunger 114 such that the thumb rest 140 of the plunger 140 reliably or consistently contacts the injection end sensor 154 when the plunger 114 is in its final position, or is positioned immediately adjacent to the injection end sensor 154. As seen in Figure 5, the external clip 190 can be positioned on the proximal-facing surface 120c of the flange extender 120 and can be configured to grip the outer edge of the flange extender 120 or otherwise clip in place. The injection end sensor 154 may be bonded to the proximal-facing surface of the external clip 190 or connected by other means. In some embodiments, the external clip 190 may position the injection completion sensor 154 such that the radial distance between the injection completion sensor 154 and the longitudinal axis A is less than or equal to the radial distance between the outermost radial portion of the thumb rest 140 and the longitudinal axis A.

[0060] The embodiments described above primarily relate to monitoring or simulating user operation of an infusion device to move a plunger to discharge a drug from the infusion device, but other embodiments of the present disclosure, including those described later, relate to monitoring other user interactions with an infusion device or a simulated infusion device, including, for example, user operation of a simulated infusion device having, for example, an improved plunger configured not to move relative to a drug container when pressed by the user.

[0061] Figure 6 shows one embodiment of the monitoring system 200 including a simulated portion of the infusion device 220. The simulated portion of the infusion device 220 can be configured to simulate, for example, the drug container 112 of the infusion device 110, or at least the distal end 112b of the drug container 112 of the infusion device 110. As an example, the simulated portion of the infusion device 220 may include the same or similar dimensions, features, geometric shape, and / or other physical and / or functional characteristics as the drug container 112 of the infusion device 110 or at least its distal end 112b. The monitoring system 200 can generally be configured to detect, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical characteristics, conditions, states, and / or traits) related to the simulated portion of the infusion device 220 and / or components connected to the simulated portion of the infusion device 220 and manual user interaction with them. In some embodiments, including the embodiment in Figure 6, the monitoring system 200 can be configured to detect, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) related to the user's removal of the removable cap, including the removable cap 182 connected to a simulated portion of the infusion device 220, in a manner that simulates the aforementioned connection between the removable cap 182 and the distal end 112 of the drug container 112 in the stored state of the infusion device 110. To these purposes, this embodiment of the monitoring system 200 may include a torque sensor 252 and / or a computing unit 256. In other embodiments, the monitoring system 200 may omit one or more of the torque sensor 252 and the computing unit 256, and / or include additional sensors and / or computing units.

[0062] In embodiments such as the one shown in Figure 6, where the simulated portion of the infusion device 220 is configured to simulate the distal end 112b of the drug container 112 of the infusion device 110, the simulated portion of the infusion device 220, or a portion thereof, may have a cylindrical or substantially cylindrical shape, and / or may have the same or substantially the same outer diameter as at least a portion of the distal end 112b of the drug container 112 of the infusion device 110. Furthermore, in such embodiments, the distal end of the simulated portion of the infusion device 220 may simulate the threaded inner surface of the Luer lock connector member 180 of the distal end 112b of the drug container 112 of the infusion device 110, or have a corresponding threaded inner surface (for example, a threaded surface facing radially inward with respect to the longitudinal axis). Therefore, the removable cap 182 can be connected to (e.g., screwed into) and / or separated from (e.g., loosened) a simulated portion of the infusion device 110 in the same or similar manner as the removable cap 182 is connected to and / or separated from a Luer lock connector member 180 at the distal end 112b of the drug container 112 of the infusion device 220.

[0063] The torque sensor 252 may be any device that senses or detects the amount of torque applied to or received by the torque sensor 252 and / or structures connected to the torque sensor 252. In some embodiments, the torque sensor 252 may include a torque transducer, a strain gauge, and / or any other device configured to convert mechanical torque into an electrical signal and / or other computer-readable signal. The torque sensor 252 may be configured to output an electrical signal or other computer-readable signal (also referred to herein as the “torque signal”) representing, for example, the magnitude of the applied torque when torque is applied to the simulated portion of the injection device 220, for example, as a result of torque applied to a removable cap 182 connected to the simulated portion of the injection device 220. The torque sensor 252 may be configured to output this signal to the computing unit 256 over the duration of the applied torque so that the computing unit 256 can monitor and analyze the temporal variation (or lack thereof) of the magnitude of the applied torque.

[0064] In some embodiments, the torque sensor 252 may be connected (e.g., directly connected) to a simulated portion of the infusion device 220 so that the torque applied to the simulated portion of the infusion device 220, including torque applied via a removable cap 182 connected to the simulated portion of the infusion device 220, can be measured by the torque sensor 252. In some embodiments, the torque sensor 252 may be configured to detect a rotation axis parallel to and / or coaxial with the longitudinal axis of the simulated portion of the infusion device 220 (e.g., including a longitudinal axis that simulates or corresponds to the longitudinal axis A of the infusion device 110). In some embodiments, as shown in Figure 6, the torque sensor 252 may be connected to a simulated end 112a of the drug container 112 of the infusion device 220 or to a corresponding end of the simulated portion of the infusion device 110. Furthermore, as shown in Figure 6, in some embodiments, the torque sensor 252 may be partially or completely housed within the sensor housing 224, which may be detachably connected to the fixture stand 226. During use or testing, the torque sensor 252 and its housing 224 may be separated from the fixture stand 226, as shown in Figure 7.

[0065] In some embodiments, the torque sensor 252 may be located on the outer surface of the simulated portion of the injection device 220, and in other embodiments, the torque sensor 252 may be located partially or completely within the simulated portion of the injection device 220, or otherwise integrated.

[0066] In some embodiments, the torque sensor 252 may be locked to prevent rotation of the simulated portion of the injection device 220 so that when a user rotates or attempts to rotate the removable cap 182 to remove it from the simulated portion of the injection device 220, the simulated portion of the injection device 220 does not rotate relative to the torque sensor 252.

[0067] In some embodiments, the monitoring system 200 may include a signal conditioner 228 connected to a torque sensor 252 and / or a computing unit 256. The signal conditioner 228 can be configured to process and / or modify the torque signal and / or other signals output by the torque sensor 222 so that they are suitable for further processing by the computing unit 256, such processing may include, for example, filtering and / or removing noise from the signal, amplifying the signal, and / or converting the signal from one form to another.

[0068] The computing unit 256 can generally be configured to receive signals output from or transmitted from any one or combination of the torque sensor 252, other sensors, and other devices, and to process those signals (e.g., by analyzing, comparing, and evaluating them) to determine one or more parameters related to the user's preparation and / or operation of the simulated portion of the injection device 220 for, for example, performing or simulating a drug injection. The computing unit 256 can perform these functions in real time, or substantially in real time, while, for example, the user prepares and / or operates the injection device 220 or the simulated portion of the simulated injection device to, for example, perform or simulate a drug injection.

[0069] In some embodiments, the computing unit 256 may have similar or identical features to those of the computing unit 56. The following description of the computing unit 256 focuses primarily on the differences between the computing unit 256 and the computing unit 56.

[0070] In some embodiments, the monitoring module can be stored in the program memory of the computing unit 256 as a set of instructions executable on the processor of the computing unit 256 and / or other processors. The monitoring module can receive and process torque signals output from the torque sensor 252, and / or signals from other sensors and / or devices, for example via the aforementioned processor, to determine and / or generate one or more parameters related to the preparation and / or operation of a simulated portion of the injection device 220 by the user for performing or simulating drug injection, for example. In some embodiments, the monitoring module of the computing unit 256 can generate graphs, charts, tables, infographics, symbols, text and / or other visual representations that are displayed via a screen or monitor included in the user interface included in the computing unit 256. Furthermore, in some embodiments, the monitoring module of the computing unit 256 can store (e.g., record) the data it generates in the monitoring parameter memory included in the computing unit 256.

[0071] One or more parameters determined by the computing unit 256 may include at least one or a combination of the following: (a) the torque-time profile of the torque applied to the simulated portion of the injection device 220 when the user is removing or attempting to remove the removable cap 182 from the simulated portion of the injection device 220; (b) the maximum torque applied to the simulated portion of the injection device 220 when the user is removing or attempting to remove the removable cap 182 from the simulated portion of the injection device 220; (c) the average maximum torque applied to the simulated portion of the injection device 220 over a selected period of time when the user is removing or attempting to remove the removable cap 182 from the simulated portion of the injection device 220; and (d) the length of time required for the user to remove or substantially remove the removable cap 182 from the simulated portion of the injection device 220. In some embodiments, any one or a combination of these parameters and / or other parameters may be analyzed to determine or investigate, for example, the limit of user force and / or the force of a target user group when removing the removable cap 182 from the injection device 110, and / or the minimum user force required to remove the removable cap 182 from the injection device 110.

[0072] In some embodiments, the computing unit 256 may be configured to generate a graph plotting the torque-time profile of the torque applied to the simulated portion of the injection device 220 when the user is removing or attempting to remove the removable cap 182 from the simulated portion of the injection device 200. This graph may include torque measured in Newton meters on the vertical, i.e., "y" axis (or another unit of measurement used to quantify torque) and time in seconds on the horizontal, i.e., "x" axis (or another unit of measurement used to quantify time). Figure 8 shows an example of such a graph. In some embodiments, the user interface of the computing unit 256 may display this graph and / or other graphs on a screen or monitor.

[0073] Monitoring the removal or attempt to remove the removable cap 182 from the simulated portion of the injection device 220 by the user may include one or more of the following steps: As a preliminary step, the user may connect the torque sensor 252 to the sensor interface and / or other elements of the computing unit 256. Next, as shown in Figure 7, the user may grasp the removable cap 182 with one or more of their hands and grasp the simulated portion of the injection device 220 with their other hand. The user may then rotate or attempt to rotate the removable cap 182 relative to the simulated portion of the injection device 220 in order to loosen, or otherwise remove or separate the removable cap 182 from the simulated portion of the injection device 220. At a minimum, while the user rotates or attempts to rotate the removable cap 182 relative to the simulated portion of the injection device 220, the torque sensor 252 can output a torque signal, and the sensor interface of the computing unit 256 can directly or indirectly receive the torque signal from the torque sensor 252. Based on the analysis, comparison, evaluation, and / or other processing of one or more of the torque signals, other sensor signals, and pre-stored information in the memory of the computing unit 256, the program memory of the computing unit 256, and / or other elements, the program memory of the computing unit 256 and / or other elements can determine any one or more of the parameters and / or other data described above related to the user's removal or attempt to remove the removable cap 182 from the simulated portion of the injection device 220. The one or more parameters and / or other data determined can be stored, for example, in the monitoring parameter memory of the computing unit 256.Furthermore, or otherwise, the program memory and / or other elements of the computing unit 256 may generate one or more visual and / or audio representations of one or more parameters and / or other data, and output those representations, for example, through the user interface of the computing unit 256 for consumption by the user and / or another individual. In some embodiments, such representations may be graphs as shown in Figure 8.

[0074] Figures 9 to 12 illustrate embodiments relating to monitoring user operation of a simulated infusion device having a modified plunger, which can be configured, for example, to not move relative to the drug container when pressed by the user. These embodiments facilitate the measurement of one or more parameters related to user operation of the infusion device at one or more predetermined operational stages, moments during operation, and the axial position of the plunger and / or stopper relative to the drug container.

[0075] Figures 9 and 10 show a simulated injection device 310, generally configured to simulate an injection device including, for example, the injection device 10 described above, provided that the injection device has a plunger that is fixed (e.g., fixed so as not to move) to a final position corresponding to the end of injection, or, alternatively, to an initial position (e.g., fixed so as not to move) corresponding to the minimum or low fill volume of the drug container. The simulated injection device 310 may include a drug container 312 (shown generally as transparent in Figure 9), a plunger 314, a needle 318, and / or a flange extender 320. In some embodiments, the drug container 312, plunger 314, needle 318, and flange extender 320 may be similar to or identical in structure, configuration, and / or function to the drug container 12, plunger 14, needle 18, and flange extender 20 described above, with at least the following differences.

[0076] The drug container 312 may not be filled with drug or may not be fillable, and / or at least a portion (or all thereof) of the distal end 312b of the drug container 312 may be solid (instead of being hollow like the distal end 312b of the drug container 12). In some embodiments, as shown in Figures 9 and 10, the distal end 312b of the drug container 312 may include at least one proximal-facing inner surface 312c located proximal to the neck or tip 312d of the drug container 312. The proximal-facing inner surface 312c of the drug container 312 may be configured to engage and / or connect with the distal-facing surface 314c of the plunger 314 so as to prevent or selectively prevent the plunger 312 from moving distally and / or proximal relative to the drug container 312 when a user applies a distal and / or proximal force to the plunger 314.

[0077] In some embodiments, the axial distance X1 between the proximal inner surface 312c and the proximal outer end surface 312e of the drug container 312 is when the distal end surface 314c of the plunger 314 engages with or contacts the proximal inner surface 312c of the drug container 312, and the axial distance X2 between the proximal surface 340a of the thumb rest 340 of the plunger 314 and the proximal outer end surface 312e of the drug container 312 is when the actual injection device is in the injection completion state (for example, the plunger of the actual injection device) The axial distance between similar faces of the actual infusion device (e.g., infusion device 10, and / or another device intended to be simulated by the simulated infusion device 310) may be selected to correspond to (e.g., be equal to or substantially equal to) the axial distance between similar faces of the actual infusion device (e.g., infusion device 10, and / or another device intended to be simulated by the simulated infusion device 310) when the plunger is in its final position, and / or when the actual infusion device is in a retracted state (e.g., when the plunger of the actual infusion device is in its initial position), and / or when it is filled with a minimum or low volume of drug (e.g., a minimum dose of drug).

[0078] In some embodiments, the needle 318 may be a simulated needle, for example, one made of plastic and / or having a blunt and / or non-sharp distal tip. In some such embodiments, the simulated needle may be configured to mimic or otherwise simulate the fluid resistance of an actual needle. Furthermore, in some embodiments, the needle 318 may be omitted.

[0079] Figure 9 shows that the simulated infusion device 310 may be connected to or part of the monitoring system 350. The monitoring system 350 can generally be configured to detect, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) related to the user's manual interaction with the simulated infusion device 310 and / or components connected to the simulated infusion device 310. In some embodiments, the monitoring system 350 may be configured to detect, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) related to the user's attempt to move the plunger 314 distally toward the drug container 312. Thus, this embodiment of the monitoring system 350 may include a force sensor 322 and / or a computing unit 356 and / or additional sensors and / or computing units.

[0080] The force sensor 352 may be any device that detects or detects the amount of force or load applied to and / or received by the force sensor 352 and / or structures connected to the force sensor 352. In some embodiments, the force sensor 352 may include load cells (e.g., compression load cells, miniature compression load cells, and / or any other suitable load cells), strain gauges, pressure transducers, and / or any other devices configured to convert mechanical forces into electrical signals and / or other computer-readable signals. The force sensor 352 may be configured to output, for example, an electrical signal or other computer-readable signal (also referred to herein as a “force signal”) representing the magnitude of the applied force when a force is applied to the plunger 314, including a distal force applied by a user to move or attempt to move the plunger 314 distally during injection or simulated injection. The force sensor 352 can be configured to output this signal to the computing unit 356 over the duration of the applied force, so that the computing unit 356 can monitor and analyze the temporal fluctuations (or lack thereof) of the magnitude of the applied force.

[0081] In some embodiments, the force sensor 352 may be connected to the plunger 314 (e.g., directly connected) so that the force applied to the plunger 314, or at least distal and / or proximal forces applied to the plunger 314 in a direction parallel or substantially parallel to the longitudinal axis A, can be measured by the force sensor 352. In some embodiments, the force sensor 352 may be at least partially located within the plunger 314 (as shown in Figure 10), or it may be fully located within the plunger 314. In other embodiments, the force sensor 352 may be located on and / or bonded to the proximal outer surface of the plunger 314, for example, including the proximal surface 340a of the thumb rest 340.

[0082] The computing unit 356 can generally be configured to receive signals output or transmitted from any one or combination of the force sensor 352, other sensors, and other devices, and to process those signals (e.g., by analyzing, comparing, and evaluating them) to determine one or more parameters related to the user's handling of the simulated injection device 310, for example, one or more predetermined operating stages, moments in operation, and the axial position of the plunger and / or stopper relative to the drug container. The computing unit 356 can perform these functions in real time or substantially in real time, for example, while the user is using the simulated injection device 310.

[0083] In some embodiments, the computing unit 356 may include features similar to or identical to those of the computing unit 56. The following description of the computing unit 356 focuses primarily on the differences between the computing unit 356 and the computing unit 56. In some embodiments, the monitoring module may be stored in the program memory of the computing unit 356 as a set of instructions executable on the processor of the computing unit 356 and / or other processors. The monitoring module may, for example, receive and process force signals output from the force sensor 352 and / or signals from other sensors and / or devices via the aforementioned processor to determine and / or generate data representing one or more parameters related to the user's handling of the simulated injection device 310 for simulating one or more predetermined operating stages, moments in operation, and / or the axial positions of the plunger and / or stopper relative to the drug container. In some embodiments, the monitoring module of the computing unit 356 may generate graphs, charts, tables, infographics, symbols, text, and / or other visual representations to be displayed via a screen or monitor included in the user interface included in the computing unit 356. Furthermore, in some embodiments, the monitoring module of the computing unit 356 can store (e.g., record) the data it generates in the monitoring parameter memory included in the computing unit 356.

[0084] One or more parameters determined by the computing unit 356 may include at least one or a combination of the following: (a) the force-time profile of the force a user applies to the plunger 314 when attempting to move the plunger 314 against the vessel 312; (b) the maximum time duration for which a user can apply force to the plunger 314 when attempting to move the plunger 314 against the vessel 312; and (c) the maximum, minimum, and / or average force a user applies to the plunger 314 when attempting to move the plunger 314 against the vessel 312. In some embodiments, one or a combination of these parameters and / or other parameters may be analyzed to determine, for example, the limits of user force and / or force for a target user group when operating an actual injection device that the simulated injection device 310 may be configured to simulate.

[0085] For example, monitoring a user's handling of the simulated injection device 310 to simulate one or more predetermined operating stages, moments in operation, and the axial positions of the plunger and / or stopper relative to the drug container may include one or more of the following steps: As a preliminary step, the user may connect the force sensor 222 to the sensor interface and / or other elements of the computing unit 356 and / or connect the force sensor 222 to the plunger 314 of the simulated injection device 310. The user may then apply a distal force to the plunger 314 by attempting to move the plunger 314 distally relative to the drug container 312. However, due to contact between the distal surface 314c of the plunger 314 and the proximal inner surface 312c of the drug container 312, and / or other fixed connections between the plunger 314 and the drug container 312, the plunger 314 may not move relative to the drug container 312. At a minimum, while the user applies a distal force to the plunger 314, the force sensor 352 can output a force signal, and the sensor interface of the computing unit 356 can receive the force signal directly or indirectly from the force sensor 352. Based on the analysis, comparison, evaluation, and / or other processing of any one or combination of the force signal, other sensor signals, and pre-stored information in the program memory of the computing unit 356, the monitoring module of the computing unit 356 can determine, for example, any one or combination of the parameters and / or other data described above relating to the user's handling of the simulated injection device 310 to simulate one or more predetermined operating stages, moments in operation, and the axial positions of the plunger and / or stopper relative to the drug container. The one or more parameters and / or other data determined can be stored, for example, in the monitoring parameter memory of the computing unit 356.Furthermore, or otherwise, the program memory and / or other elements of the computing unit 356 may generate one or more visual and / or audio representations of one or more parameters and / or other data, and output those representations, for example, through the user interface of the computing unit 356 for consumption by a user and / or another individual.

[0086] Figures 11 and 12 show another embodiment of the simulated injection device, indicated by reference numeral 410, whose preparation and / or operation by the user can be monitored by the monitoring system 350 and associated methods described above. Various features of the injection device 410 in Figures 11 and 12 may be similar or identical in structure, configuration and / or function to the features of the simulated injection device 310 described above in relation to Figures 9 and 10. Such components are assigned the same reference numerals as those used in Figures 9 and 10, except that they are increased by 100. Some descriptions of these features have been simplified or omitted for brevity.

[0087] The simulated injection device 410 is generally configured to simulate an injection device, for example, the injection device 10 described above, provided that the injection device has a plunger that is fixed in an initial position (for example, fixed so as not to move) corresponding to, for example, the stored state and / or the maximum or high-fill capacity of the drug container. The simulated injection device 410 may include a drug container 412, a plunger 414, a needle 418 and / or a flange extender 420. In some embodiments, the drug container 412, the plunger 414, the needle 418 and the flange extender 420 may be similar to or identical to the drug container 312, the plunger 314, the needle 318 and the flange extender 320 described above in terms of structure, configuration and / or function, with at least the following differences.

[0088] The axial distance X3 between the proximal surface 412c of the drug container 412 and the proximal outer end surface 412e of the drug container 412 may be selected such that, when the distal end surface of the plunger 414 engages with or contacts the proximal inner surface 412c of the drug container 412, the axial distance between the proximal surface 440a of the thumb rest 440 of the plunger 414 and the proximal outer end surface of the drug container 412 corresponds to (e.g., is equal to or substantially equal to) the axial distance between similar surfaces of the actual infusion device (e.g., infusion device 10, and / or another device intended to be simulated by the simulated infusion device 410) when the actual infusion device is in a retracted state (e.g., when the plunger of the actual infusion device is in its initial position) and / or when the actual infusion is filled with the maximum or high volume of drug (e.g., the maximum dose of drug). The axial distance X3 may be smaller than the axial distance X1.

[0089] For example, monitoring the user's handling of the simulated injection device 410 to simulate one or more predetermined operating stages, moments in operation, and the axial position of the plunger and / or stopper relative to the drug container may include one or more of the steps described above or similar to the steps for monitoring the simulated injection device 310 via the monitoring system 350.

[0090] Figure 13 shows an additional embodiment of the simulated injection device indicated by reference numeral 510, whose preparation and / or operation by the user can be monitored by the monitoring system 350 and associated methods described above. Various features of the injection device 510 in Figure 13 may be similar or identical in structure, configuration and / or function to the features of the simulated injection device 410 described above in relation to Figures 11 and 12. Such components are assigned the same reference numerals as those used in Figures 11 and 12, except that they are increased by 200. Some descriptions of these features have been simplified or omitted for brevity.

[0091] The simulated injection device 510 is generally configured to simulate a safety syringe, but only if the safety syringe has a plunger that is fixed (e.g., fixed so as not to move) in an initial position corresponding to, for example, the stowed state and / or the maximum or high-fill volume of the drug container. In an alternative embodiment, the simulated injection device 510 may generally be configured to simulate a safety syringe only if the safety syringe has a plunger that is fixed (e.g., fixed so as not to move) in a final position corresponding to, for example, the end-of-injection state, or alternatively, fixed (e.g., fixed so as not to move) in an initial position corresponding to the minimum or low-fill volume of the drug container. The simulated injection device 510 may include a drug container 512, a plunger 514, a needle 518 and / or a flange extender 520. In some embodiments, the drug container 512, plunger 514, needle 518, and flange extender 520 may be similar to or identical to the drug container 412, plunger 414, needle 418, and flange extender 420 described above, except for the following differences:

[0092] The simulated injection device 510 may include a needle cover 590 configured to simulate a needle cover that selectively moves relative to the needle 518 to cover the needle 518 when the plunger 514 is in its final position and / or in the end of injection state or when it is in such a state. In some embodiments, the needle cover 590 may move in a similar manner to the needle cover it is intended to simulate and otherwise function similarly, but in other embodiments, the needle cover 590 may be fixed and coupled to the drug container 514 (e.g., coupled in a way that prevents movement) so that the needle cover 590 does not move relative to the needle 518 during use of the simulated injection device 510.

[0093] Furthermore, in some embodiments, the simulated injection device 510 may include a spring biasing mechanism 592 configured to simulate a spring biasing mechanism that automatically moves the needle cover 590 to cover the needle 518 when the plunger 514 is in its final position and / or injection completion state or if it is. In some embodiments, the spring biasing mechanism 592 may automatically move the needle cover 590 in a similar manner to the spring biasing mechanism it is intended to simulate, and otherwise function similarly, but in other embodiments, the spring biasing mechanism 592 may prevent the needle cover 590 from automatically moving to cover the needle 518 (for example, via a fixed connection with the drug container 512).

[0094] In some embodiments, such as that shown in Figure 13, the force sensor 352 can be positioned and / or connected to the proximal end of the plunger 514 so that the user's thumb can directly contact the force sensor 352 or the housing housing the force sensor 352 when the user handles the simulated injection device 510 to simulate drug injection. In other embodiments, the force sensor 352 may be at least partially positioned within the plunger 514, for example, as shown in the arrangement in Figure 10.

[0095] For example, monitoring the user's handling of the simulated injection device 510 to simulate one or more predetermined operating stages, moments in operation, and the axial position of the plunger and / or stopper relative to the drug container may include one or more of the steps described above or similar to the steps described above with respect to monitoring the simulated injection device 310 and / or simulated injection device 410 via the monitoring system 350.

[0096] In some embodiments, the force sensor 352 and / or other force sensors may be configured to detect or sense the force applied by the user to activate (e.g., release) the spring biasing mechanism 592 so that the spring biasing mechanism 592 automatically moves the needle cover 590 to cover the needle 518, for example, at the end of injection. Furthermore or alternatively, the force sensor 352 and / or other force sensors may be configured to detect or sense any force that may be applied to and / or felt by the user as a result of (e.g., caused by) the activation and / or operation of the spring biasing mechanism 592.

[0097] Figures 14–16 show one embodiment of a plunger, reference numeral 614, for discharging a drug from a drug delivery device, such as a syringe. Plunger 614 can be used in any of the systems, devices, and methods described above, for example, as a replacement for plunger 14 of infusion device 10. Various features of the plungers in Figures 14–16 may be similar or identical in structure, configuration, and / or function to the features of plunger 14 described above in relation to Figures 1 and 2. Such components are assigned the same reference numerals as those used in Figures 1 and 2, except that they are increased by 600. Some descriptions of these features have been simplified or omitted for brevity.

[0098] In some cases, measuring the length of a plunger before use may be useful or even essential. For example, it may be necessary to verify the accuracy of the plunger length to ensure that the plunger can travel the required distance within the syringe barrel to dispense the indicated amount of drug from the syringe. In particular, in medical applications where accurate dosage is required for patient safety, it may be necessary to measure and verify the length of the plunger before use. The measurement may be performed, for example, by the manufacturer as part of the quality control process and / or by the user of the plunger. Furthermore, ensuring that the plunger has a standardized length may, in some cases, make it possible to swap plungers between different syringe brands and models. The plunger 614 shown in Figures 14-16 is configured to facilitate such measurement of its length.

[0099] The plunger 614 extends along the longitudinal axis B and may have a proximal end 614a and a distal end 614b. At least the distal end 614b may be configured to be at least partially located within a drug container of a drug delivery device, for example, including a drug container 12 of an infusion device 10. The distal end 614b may include a threaded portion 680 configured to screw-engage with a stopper, for example, including a stopper 16.

[0100] The proximal end 614a of the plunger 614 can generally be configured to allow a user and / or machine to apply a distally directed force to the plunger 614, for example, to move the plunger 614 within a drug container during operation of a drug delivery device. In some embodiments, the proximal end 614a of the plunger 614 may include a pressing surface 682 configured to facilitate the application of a distally directed force to the plunger 614 during operation of a drug delivery device. The pressing surface 682 may be flat or substantially flat and may face proximal or substantially proximal. Furthermore, in some embodiments, the pressing surface 682 may define at least a portion of the outermost edge 683 of the proximal end 614a of the plunger 614. In some embodiments, the outermost edge 683 may correspond to the radially outermost edge of the proximal end 614a of the plunger 614.

[0101] In some embodiments, the pressing surface 682 may correspond to a surface facing the proximal end of the thumb rest 640. The thumb rest 640 can be configured to allow the user to press their thumb against the plunger 614 during operation of the drug delivery device and push it distally to eject the drug from the drug container. The thumb rest 640 may have an enlarged cross-section compared to the distal end 614b of the plunger 614 and may include a radially outward-extending flange 684 that overhangs a portion of the plunger 614 distal to the thumb rest 640. This configuration allows the thumb rest 640 to provide an increased surface area for the user to rest their thumb when pressing against the plunger 614.

[0102] The proximal end 614a of the plunger 614 may further include an anti-slip member 686 configured to prevent or block lateral or radial movement of a thumb, other fingers, and / or other objects relative to the pressing surface 682 when a distal force is applied to the pressing surface 682. In some embodiments, the anti-slip member 686 may extend proximal to the pressing surface 682. The anti-slip member 686 may include one or more protruding structures and / or textures applied to the pressing surface 682 or a portion thereof, as shown in Figures 14 to 16. In some embodiments, the anti-slip member 686 may define at least a portion of the outermost edge 683 of the proximal end 614a of the plunger 614.

[0103] In some embodiments, the anti-slip member 686 may include an annular projection 688 extending proximal to the pressing surface 682. The annular projection 688 or a portion thereof may have a radius of curvature similar to that of the outermost edge 683 of the proximal end 614a of the plunger 614. As will be described later, the annular projection 688 may include one or more openings, and its ring shape may not be continuous in the circumferential direction, but instead have one or more discontinuous portions in the circumferential direction.

[0104] Because the anti-slip member 686 extends proximal to the pressing surface 682, when the plunger 614 is viewed laterally from the side, it may obstruct the view of the pressing surface 682 depending on the viewer's position. As a result, measuring the length of the plunger 614 between the pressing surface 682 and a portion of the distal end 614b of the plunger 614, such as length L in Figure 14, may be impossible or significantly complicated. For example, when measuring or determining the axial position of the pressing surface 682 using a light beam directed perpendicular to the longitudinal axis B, the anti-slip member 686 may obstruct the light beam (depending on the position of its light source), which may result in an inaccurate measurement of the axial position and / or length L of the pressing surface 682.

[0105] To address this problem, the anti-slip member 686 can be configured to facilitate measuring the length of the plunger 614 between the pressing surface 682 and another part of the plunger 618, such as a portion of the distal end 614b of the plunger 618. For example, the anti-slip member 686 may include one or more openings (e.g., holes, slots, notches, apertures, recesses, grooves, discontinuities, etc.) to improve the visibility of the pressing surface 682, for example, when the pressing surface 682 is viewed laterally from the side, for example, when viewed radially with respect to the longitudinal axis B. In a more specific example, one or more openings may be arranged such that one or more first portions of the outermost edge 683 of the proximal end 614a of the plunger 614 are at least partially defined by the pressing surface 682, and one or more second portions of the outermost edge 683 of the proximal end 614a of the plunger 614 are at least partially defined by the anti-slip member 686. As a more specific example, one or more pairs of openings may be formed in the anti-slip member 868, each pair of openings spaced circumferentially 180 degrees or approximately (e.g., ±10%) 180 degrees from each other around the proximal end 614a of the plunger 614. A pair of such openings can facilitate the measurement of an optical base of length L by allowing, for example, a light beam to pass through the anti-slip member 686, which could be useful, for example, for locating the position of the pressing surface 682.

[0106] Figure 16 shows that the annular projection 688 includes a first opening 690 and a second opening 692. In other embodiments, fewer or additional openings may be included. The first opening 690 is configured such that a first portion 682a of the pressing surface 682 is not covered by the annular projection 688, and the second opening 692 is configured such that a second portion 682b of the pressing surface 682 is not covered by the ring-shaped projection 688. The first opening 690 and the second opening 692 may be spaced circumferentially 180 degrees or approximately (e.g., ±10%) 180 degrees around the proximal end 614a of the plunger 614. Other spacings between the first opening 690 and the second opening 692 are also possible. In some embodiments, the first opening 690 and the second opening 692 may give the annular projection 688 the appearance of two C-shaped members when viewed from above, as seen in Figure 16.

[0107] All features described herein, including this specification, the claims, the abstract, and the drawings, as well as all steps in any method or process described herein, may be combined in any combination, except for any combination in which one or more of these features and / or steps are mutually exclusive.

[0108] As can be understood, the systems and methods described herein may have one or more advantages over the prior art, any one or more of which may exist in particular embodiments according to the features of the disclosure included in those embodiments. Other advantages not specifically mentioned herein may also be understood.

[0109] The above description relates to various devices, assemblies, components, subsystems, and methods used in connection with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, the drugs specified below, and their generic and biosimilar equivalents, but not limited to those drugs. As used herein, the term "drug" may be interchangeable with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional medicines, dietary supplements, supplements, biological preparations, biological activators and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid, lyophilized, or reconstituted forms from lyophilized forms. The following list of exemplary drugs should not be considered exhaustive or restrictive.

[0110] The drug is contained within a reservoir. In some cases, the reservoir is a primary container that is either filled with or pre-filled with the drug for therapeutic purposes. The primary container may be a vial, cartridge, or pre-filled syringe.

[0111] In some embodiments, the reservoir of a drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used in conjunction with such factors. Examples of such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0112] In other embodiments, drug delivery devices may contain or be used with erythropoiesis-stimulating factors (ESAs), which may be in liquid or lyophilized form. ESAs are any molecules that stimulate erythropoiesis. In some embodiments, ESAs are erythropoiesis-stimulating proteins. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing dimerization of the receptor. Examples of erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Examples of erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin a). Examples include, but are not limited to, epoetin alpha (alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0113] Particularly exemplary proteins include the specific proteins listed below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies, peptide bodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies (also referred to as RANKL-specific antibodies, peptide bodies, etc.); myostatin-binding proteins, peptide bodies, and related proteins, including myostatin-specific peptide bodies; IL-4 receptor-specific antibodies, peptide bodies, and related proteins, particularly those that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; and Tahleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptide bodies, related proteins, etc.; Ang2 specific antibodies, peptide bodies, related proteins, etc.; NGF specific antibodies, peptide bodies, related proteins, etc.; CD22 specific antibodies, peptide bodies, related proteins, etc., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, for example, epratuzumab (CAS registry number 501423-23-0) Human CD22-specific IgG antibodies, including but not limited to human CD22-specific fully humanized antibodies such as CD22-specific fully humanized antibodies; human CD22-specific antibodies, including but not limited to humanized and fully human monoclonal antibodies; humanized and fully human antibodies, including but not limited to anti-IGF-1R antibodies; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins, including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies; fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; B7-related protein 1-specific antibodies, peptide bodies, and related proteins, including but not limited to those that inhibit the interaction between B7RP-1 and its native receptor ICOS on activated T cells (also referred to as "B7RP-1," as well as B7H2, ICOSL, B7h, and CD275); e.g., 145c7, HuMax This includes, but is not limited to, IL-15 antibodies and related proteins, particularly IL-15-specific antibodies such as humanized monoclonal antibodies, peptide bodies, and related proteins;Includes, but is not limited to, human IFN-gamma specific antibodies, peptide bodies, and related proteins, including, but not limited to, fully human anti-IFN-gamma antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopoietin receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; and fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as NAL antibodies; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-beta-specific antibodies, peptide bodies, and related proteins; amyloid-beta protein-specific antibodies, peptide bodies, and related proteins; and proteins that bind to c-Kit and / or other stem cell factor receptors, but is not limited to these. No, c-Kit specific antibodies, peptide bodies, related proteins, etc.; OX40L specific antibodies, peptide bodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa); erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine]; darbepoetin alfa; novel erythropoiesis-stimulating protein NESP; Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (aremtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti® (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin® or other product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (Trademark) (Panitumumab), Xgeva (Registered Trademark) (Denosumab), Prolia (Registered Trademark) (Denosumab), Immunoglobulin G2 Human Monoclonal Antibody against RANK Ligand, Enbrel (Registered Trademark) (Etanercept, TNF Receptor / Fc Fusion Protein, TNF Blocker), Nplate (Registered Trademark) (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution; Infergen (Registered Trademark) (Interferon Alphacon-1); Natrecor (Registered Trademark) (Nesiritide; Recombinant Human Type B Natriuretic Peptide (hBNP); Kineret (Registered Trademark) (Anakinra); Leukine (Registered Trademark) (Sargamostim, rhuGM-CSF); LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex(registered trademark) (17-1A, edrecolomab); Trabio(registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem(registered trademark) (IDM-1); OvaRex(registered trademark) (B43.13); Nuvion(registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon(registered trademark) (epoetin beta); Neumega(registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (epoetin alfa); Remicade(registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (absiximab, anti-GP) Ib / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanorimumab); Mvasi® (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark)-(interferon alpha-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (saltumumab); M200 (boroxiximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; Anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388); Anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); Anti-CD25 mAb (HuMax-TAC); Anti-CD3 mAb (NI-0401); Adekatumumab; Anti-CD30 mAb (MDX-060); MDX-1333 (Anti-IFNAR); Anti-CD38 mAb (HuMax CD38); Anti-CD40L mAb; Anti-Cripto mAb; Anti-CTGF idiopathic pulmonary fibrosis stage I fibrogen (FG-3019); Anti-CTLA4 mAb; Anti-eotaxin 1 mAb (CAT-213); Anti-FGF8 mAb; Anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesoterin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (H; uMax-ZP3).

[0114] In some embodiments, the drug delivery device may contain or be used with sclerostin antibodies, such as romosozumab, brosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), and other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, as well as, in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with, or the device may be used with, IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207,1716;NV1020;NV12023;NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors (TIMPs) of metalloproteinases, including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with, Aimovig® (Erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonist antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to erenumab and bispecific antibody molecules targeting the CGRP receptor and other headache targets, can also be delivered using the drug delivery device of this disclosure.Furthermore, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to apelin or its analogues. In some embodiments, therapeutically effective doses of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibodies may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola® (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-4-yl]acetamide or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used with Parsabiv® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used with another product containing ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF inhibitor such as a non-antibody VEGF inhibitor and / or a VEGF trap such as aflibercept (fused to the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2, and the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamutib mecarbil, a small molecule selective cardiac myosin activator, or another product containing myotrope, which directly targets the cardiac contractile mechanism, or a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotrasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor.In some embodiments, the drug delivery device may contain or be used with tezeperumab, a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita® or Amgevita® (formerly ABP501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product containing the half-life extension (HLE) anti-prostate-specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain or be used with AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133 or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extension (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing anti-PD-1 × IL-21 mutaine and / or an IL-21 receptor agonist designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing the anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being studied as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 427, or the half-life extension (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multispecific FAP×4-1BB-targeted DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19×CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavalakin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device is AMG 59. 6, or another product containing the CD3 × epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule may be accommodated or used together with it. In some embodiments, the drug delivery device may be accommodated or used together with it. AMG 673, or another product containing the long-lived (HLE) anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may be accommodated or used together with it. AMG 701, or another product containing the long-lived (HLE) anti-B cell maturation antigen (BCMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may be accommodated or used together with it. AMG 757, or another product containing the long-lived (HLE) anti-delta-like ligand 3 (DLL3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing the HLE (Hyperlife Extension) epithelial cell tight junction protein claudin 18.2×CD3 BiTE® (bispecific T cell engager) construct.

[0115] While drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, these are not limited to exemplary embodiments. The detailed descriptions should be interpreted as illustrative only and do not describe all possible embodiments of the Disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but these embodiments still fall within the scope of the claims defining the invention disclosed herein.

[0116] Those skilled in the art will understand that a variety of modifications, alterations, and combinations can be made to the embodiments described herein without departing from the spirit and scope of the invention as disclosed herein, and that such modifications, alterations, and combinations will be construed as falling within the scope of the concept of the invention.

Claims

1. A monitoring system for an infusion device or simulated infusion device comprising a drug container and a plunger at least partially disposed within the drug container, A force sensor configured to output a force signal when a user applies force to the plunger in order to operate the infusion device or the simulated infusion device to perform or simulate drug infusion, A computing unit configured to determine at least one parameter related to the user's operation of the injection device or the simulated injection device from at least the force signal, A monitoring system equipped with the following features.

2. The monitoring system according to claim 1, wherein the at least one parameter determined by the computing unit includes a force-time profile of the force applied to the plunger when the user operates the infusion device or the simulated infusion device to perform or simulate the drug infusion.

3. The monitoring system according to claim 1 or 2, wherein the at least one parameter determined by the computing unit includes the time at which the user initiates or simulates the drug infusion.

4. The monitoring system according to claim 3, wherein the computing unit is configured to determine the point in time when the user begins to perform or simulate the drug injection, without input from any sensor other than the force sensor.

5. The monitoring system according to any one of claims 1 to 4, wherein the force sensor is configured to be connected to the plunger.

6. The monitoring system according to claim 5, wherein at least a portion of the force sensor is positionable between the user's thumb and / or other fingers and the thumb rest of the plunger during operation of the injection device or the simulated injection device.

7. The monitoring system according to any one of claims 1 to 6, wherein the force sensor includes a compression load cell.

8. The monitoring system according to any one of claims 1 to 7, wherein the force sensor is at least partially positionable within the plunger.

9. The monitoring system according to any one of claims 1 to 8, further comprising an injection completion sensor configured to output an injection completion signal when the user moves the plunger from an initial position to a final position relative to the drug container during operation of the injection device or the simulated injection device.

10. The monitoring system according to claim 9, wherein the computing unit is configured to determine the at least one parameter by processing the force signal and the injection completion signal.

11. The monitoring system according to claim 10, wherein the at least one parameter determined by the computing unit includes the length of time the user completes or substantially completes the drug infusion using the infusion device or the simulated infusion device.

12. The monitoring system according to any one of claims 9 to 11, wherein the computing unit is configured to determine the at least one parameter relating to the operation of the infusion device or the simulated infusion device from the infusion completion signal, the at least one parameter including the time when the drug infusion is completed or substantially completed.

13. The monitoring system according to any one of claims 9 to 12, comprising a flange extender connected to the drug container, wherein the injection completion sensor is connected to the flange extender.

14. The monitoring system according to claim 13, further comprising a clip configured to connect the injection completion sensor to the flange extender.

15. The monitoring system according to any one of claims 9 to 14, wherein the injection completion sensor is positionable such that it does not contact the plunger when the plunger is in the initial position, and contacts the plunger when the plunger is in the final position.

16. The monitoring system according to any one of claims 9 to 15, wherein the injection completion sensor includes a touch sensor.

17. The monitoring system according to claim 16, wherein the touch sensor is a piezoelectric touch sensor.

18. The monitoring system according to any one of claims 1 to 17, comprising the injection device or the simulated injection device, wherein at least a portion of the plunger is movably disposed within the drug container.

19. The monitoring system according to claim 18, wherein the injection device or the simulated injection device comprises a needle fixedly connected to the drug container.

20. The monitoring system according to claim 19, wherein the injection device or the simulated injection device includes a spring biasing mechanism configured to automatically cover the needle when the plunger is in the final position.

21. The monitoring system according to any one of claims 18 to 20, wherein the injection device or the simulated injection device is a pre-filled syringe or a simulated pre-filled syringe.

22. The monitoring system according to any one of claims 18 to 21, wherein the injection device or the simulated injection device is a Luer lock syringe or a simulated Luer lock syringe.

23. A monitoring system according to any one of claims 1 to 8, comprising the simulated injection device, wherein the plunger of the simulated injection device is connected to the drug container of the simulated injection device, and when the user applies force to the plunger of the simulated injection device, the plunger of the simulated injection device does not move relative to the drug container of the simulated injection device.

24. The monitoring system according to claim 23, wherein the plunger is positioned relative to the drug container to simulate at least one of the following: the drug container being filled with drug to its maximum capacity, and the plunger being in its initial position.

25. The monitoring system according to claim 23 or 24, wherein the plunger is positioned relative to the drug container to simulate the end of the injection state of the plunger.

26. The monitoring system according to any one of claims 23 to 25, wherein the simulated injection device comprises a needle or simulated needle fixedly connected to the drug container.

27. The monitoring system according to claim 26, wherein the simulated injection device is sized to simulate a pre-filled syringe.

28. The monitoring system according to any one of claims 23 to 27, wherein the simulated injection device is sized to simulate a safety syringe.

29. The monitoring system according to any one of claims 23 to 28, wherein the simulated injection device is sized to simulate a Luer lock syringe.

30. A method for monitoring the operation of an injection device or simulated injection device comprising a drug container and a plunger at least partially positioned within the drug container, When a user applies force to the plunger in order to operate the infusion device or the simulated infusion device to perform or simulate drug infusion, a force signal is received from or via the force sensor. Determining at least one parameter related to the user's operation of the injection device or the simulated injection device from at least the force signal, Methods that include...

31. The method according to claim 30, wherein the at least one parameter includes a force-time profile of the force applied to the plunger when the user operates the infusion device or the simulated infusion device to perform or simulate the drug infusion.

32. The method according to claim 30 or 31, wherein the at least one parameter includes the time at which the user initiates or simulates the drug injection.

33. The method according to any one of claims 30 to 32, comprising outputting at least one visual and / or audio representation of the at least one parameter relating to the operation of the injection device or simulated injection device.

34. The method according to any one of claims 30 to 33, comprising receiving an injection completion signal from or via an injection completion sensor when the user moves the plunger from an initial position to a final position relative to the drug container during operation of the injection device or the simulated injection device.

35. The method according to claim 34, wherein determining the at least one parameter relating to the operation of the injection device or the simulated injection device is a process of processing the force signal and the injection completion signal, and thus determining the at least one parameter relating to the operation of the injection device or the simulated injection device.

36. The method according to claim 35, wherein the at least one parameter includes the length of time it takes for the user to complete or substantially complete the drug infusion when operating the infusion device or the simulated infusion device.

37. The method according to any one of claims 30 to 34, wherein the plunger is connected to the drug container so that the plunger does not move relative to the drug container when the user applies the force to the plunger.

38. It is a system, An injection device or simulated injection device comprising a drug container and a plunger at least partially disposed within the drug container, wherein the plunger is movable relative to the drug container from an initial position to a final position during operation of the injection device or simulated injection device, A force sensor connected to the plunger and configured to output a force signal when a user applies force to the plunger to operate the infusion device or the simulated infusion device to perform or simulate drug infusion, An injection completion sensor, connected to the drug container and configured to output an injection completion signal when the plunger is in the final position, A system equipped with these features.

39. The system according to claim 38, comprising a flange extender connected to the drug container, wherein the injection completion sensor is located on the flange extender.

40. The system according to claim 39, wherein the injection completion sensor is positioned on the proximal surface of the flange extender and contacts the distal surface of the plunger when the plunger is in the final position.

41. The system according to any one of claims 38 to 40, wherein the injection completion sensor includes a touch sensor.

42. The system according to any one of claims 38 to 41, wherein the force sensor includes a compression load cell.

43. The system according to any one of claims 38 to 42, wherein the force sensor is at least partially located within the plunger.

44. The system according to any one of claims 38 to 43, wherein the plunger includes a distal end and a proximal end, the distal end of the plunger is at least partially located within the drug container, the proximal end of the plunger includes a thumb rest, and the force sensor is located on the surface facing the proximal side of the thumb rest.

45. The system according to any one of claims 38 to 44, wherein the injection device or the simulated injection device is a pre-filled syringe or a simulated pre-filled syringe.

46. The system according to any one of claims 38 to 45, wherein the injection device or the simulated injection device is a safety syringe or a simulated safety syringe.

47. The system according to any one of claims 38 to 46, wherein the injection device or the simulated injection device is a Luer lock syringe or a simulated Luer lock syringe.

48. It is a system, A simulated injection device comprising a drug container and a plunger at least partially disposed within the drug container, wherein the plunger is connected to the drug container and does not move relative to the container when a user applies force to the plunger to simulate drug injection. A force sensor connected to the plunger and configured to output a force signal when the user applies force to the plunger to simulate drug injection, A system equipped with these features.

49. The system according to claim 48, wherein the force sensor is at least partially located within the plunger.

50. The system according to claim 48 or 49, wherein the plunger includes a distal end and a proximal end, the distal end of the plunger is at least partially located within the drug container, the proximal end of the plunger includes a thumb rest, and the force sensor is located on the proximal surface of the thumb rest.

51. The system according to any one of claims 48 to 50, wherein the force sensor includes a compression load cell.

52. The system according to any one of claims 48 to 51, wherein the plunger is positioned relative to the drug container to simulate at least one of the following: the drug container being filled with drug to its maximum capacity, and the plunger being in its initial position.

53. The system according to any one of claims 48 to 52, wherein the plunger is positioned relative to the drug container to simulate the end of the injection state of the plunger.

54. The system according to any one of claims 48 to 53, wherein the simulated injection device is sized to simulate a pre-filled syringe.

55. The system according to any one of claims 48 to 54, wherein the simulated injection device is sized to simulate a safety syringe.

56. The system according to any one of claims 48 to 55, wherein the simulated injection device is sized to simulate a Luer lock syringe.

57. A monitoring system for a removable cap of an injection device, A simulated portion of the injection device, configured to connect the removable cap to the monitoring system, A torque sensor is configured to output a torque signal when a user rotates or attempts to rotate the removable cap in order to remove the removable cap from the simulated portion of the injection device. A monitoring system equipped with the following features.

58. The monitoring system according to claim 57, comprising a computing unit configured to determine, from at least the torque signal, at least one parameter relating to the user's removal or attempt to remove the removable cap from the simulated portion of the injection device.

59. The monitoring system according to claim 58, wherein the at least one parameter determined by the computing unit includes a torque-time profile of the torque applied by the user when removing or attempting to remove the removable cap from the simulated portion of the injection device.

60. The monitoring system according to claim 58 or 59, wherein the at least one parameter determined by the computing unit includes the maximum torque applied by the user when removing or attempting to remove the removable cap from the simulated portion of the injection device.

61. The monitoring system according to any one of claims 58 to 60, wherein the at least one parameter determined by the computing unit includes the average maximum torque applied over a selected period of time when the user removes or attempts to remove the removable cap from the simulated portion of the injection device.

62. The monitoring system according to any one of claims 58 to 61, wherein the at least one parameter determined by the computing unit includes the length of time the user removes or substantially removes the removable cap from the simulated portion of the injection device.

63. The monitoring system according to any one of claims 57 to 62, wherein the simulated portion of the injection device is configured to removably connect the removable cap to the monitoring system.

64. The monitoring system according to any one of claims 57 to 63, wherein the torque sensor is a torque converter.

65. A monitoring system according to any one of claims 57 to 64, wherein when the user rotates or attempts to rotate the removable cap to remove it from the simulated portion of the injection device, the simulated portion of the injection device rotates and locks relative to the torque sensor so that the simulated portion of the injection device does not rotate relative to the torque sensor.

66. The monitoring system according to any one of claims 57 to 65, wherein the simulated portion of the infusion device is sized to simulate at least a portion of the drug container of the infusion device.

67. The monitoring system according to claim 66, wherein at least a portion of the simulated portion of the infusion device is at least substantially cylindrical and / or has an outer diameter corresponding to the outer diameter of the drug container of the infusion device.

68. The monitoring system according to any one of claims 57 to 67, wherein the simulated portion of the injection device has a proximal end and a distal end, the proximal end is connected to the torque sensor, and the distal end is configured to connect the removable cap to the simulated portion of the injection device.

69. The monitoring system according to claim 68, wherein the distal end of the simulated portion of the injection device includes a threaded surface configured to engage with the threaded surface of the removable cap.

70. The monitoring system according to claim 69, wherein the threaded surface of the distal end of the simulated portion of the injection device faces radially inward.

71. A monitoring system according to any one of claims 68 to 70, comprising a housing, wherein the proximal ends of the torque sensor and the simulated portion of the injection device are each at least partially located within the housing.

72. A method for monitoring a removable cap connected to a simulated portion of an injection device, When a user rotates or attempts to rotate the removable cap in order to remove it from the simulated portion of the injection device, a torque signal is received from or via the torque sensor. Determining from at least the torque signal at least one parameter related to the user's removal or attempt to remove the removable cap from the simulated portion of the injection device, Methods that include...

73. The method according to claim 72, further comprising outputting at least one visual and / or audio indication of the at least one parameter relating to the user's removal or attempt to remove the removable cap from the simulated portion of the injection device.

74. The method according to claim 73 or the method according to claim 73, wherein the at least one parameter includes a torque-time profile of the torque applied when the user removes or attempts to remove the removable cap from the simulated portion of the injection device.

75. The method according to any one of claims 72 to 74, wherein the at least one parameter determined includes the maximum torque applied by the user when removing or attempting to remove the removable cap from the simulated portion of the injection device.

76. The method according to any one of claims 72 to 75, wherein the at least one parameter determined includes the average maximum torque applied over a selected period of time when the user removes or attempts to remove the removable cap from the simulated portion of the injection device.

77. The method according to any one of claims 72 to 76, wherein the at least one parameter determined includes the length of time the user has to remove or substantially remove the removable cap from the simulated portion of the injection device.

78. A plunger for a drug delivery device, A distal end configured to be at least partially positioned within the drug container of the drug delivery device, The proximal end, A pressing surface configured to facilitate the application of distal force to the plunger during operation of the drug delivery device, A proximal end comprising: an anti-slip member extending proximal to the pressing surface and configured to facilitate measuring the length of the plunger between the pressing surface and another portion of the plunger; A plunger equipped with a plunger.

79. The plunger according to claim 78, wherein the proximal end of the plunger includes the outermost edge, at least a first portion of the outermost edge is at least partially defined by the pressing surface, and at least a second portion of the outermost edge is at least partially defined by the anti-slip member.

80. The plunger according to claim 78 or 79, wherein the anti-slip member includes an annular projection extending in the proximal direction from the pressing surface.

81. The plunger according to claim 80, wherein the annular projection at least partially defines the outermost edge of the proximal end of the plunger.

82. The plunger according to claim 80 or 81, wherein the annular projection is discontinuous in the circumferential direction.

83. The plunger according to any one of claims 80 to 82, wherein the annular projection includes a first opening configured such that at least a first portion of the pressing surface is not covered by the annular projection.

84. The plunger according to claim 83, wherein the annular projection includes a second opening configured such that at least a second portion of the pressing surface is not covered by the annular projection.

85. The plunger according to claim 84, wherein the first opening and the second opening are spaced 180 degrees or approximately 180 degrees apart from each other in the circumferential direction.

86. The plunger according to any one of claims 78 to 85, wherein the proximal end of the plunger includes a thumb rest, and the surface facing the proximal side of the thumb rest includes the pressing surface.

87. The plunger according to claim 86, wherein the thumb rest includes a flange extending radially outward.

Images