Monitoring systems and methods for injection devices

Abstract

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

Description

MONITORING SYSTEMS AND METHODS FOR INJECTION DEVICESCROSS-REFERENCE TO RELATED APPLICATION

[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 526,906, filed July 14, 2023, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE

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

[0003] Preparing and operating an injection device such as a syringe for drug delivery in many cases requires a user to manually handle, manipulate, configure, position, connect, disconnect, and / or interact various components of the injection device. As an example, the user may be required to twist off a protective cap covering a dispensing element prior to using a syringe to perform an injection As another example, a user may be required to push a plunger through a barrel of the syringe to expel the drug contained therein.

[0004] In situations where the user is at least partly responsible for manually preparing or operating the injection device, it may be beneficial or even essential for the design of the device to account for various human factors and ergonomic considerations. These considerations may encompass factors such as ensuring that an acceptable percentage of a target user population, or the general population, has the strength, stamina, and / or dexterity needed to prepare and operate the injection device in a safe and effective manner. Moreover, in some instances, design choices which may improve the usability of the injection device may not coincide with, or may even conflict with, operational needs such as sealing requirements for ensuring drug sterility and force demands determined by drug viscosity characteristics. Thus, incorporating human factors and ergonomic considerations into the design of an injection device can be a challenging endeavor.

[0005] To address one or one of the needs and challenges mentioned herein and other related needs and challenges, the present disclosure set forth advantageous monitoring systems and methods for injection devicesSUMMARY

[0006] One aspect of the present disclosure provides a monitoring system for an injection device or simulated injection device. The injection device or simulated injection device may include a drug container and a plunger disposed at least partially within the drug container. The monitoring system may include a force sensor configured to output a force signal when a user applies a force to the plunger to operate the injection device or simulated injection device to perform or simulate a drug injection. 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 operation of the injection device or simulated injection device by the user.

[0007] Another aspect of the present disclosure provides a method of monitoring operation of an injection device or simulated injection device. The injection device may include a drug container and a plunger disposed at least partially within the drug container. The method may include: receiving, from or via a force sensor, a force signal when a user applies a force to the plunger to operate the injection device or simulated injection device to perform or simulate a drug injection; and / or determining, from at least the force signal, at least one parameter relating to the operation of the injection device or simulated injection device by the user.

[0008] An additional aspect of the present disclosure provides a system including an injection device or simulated injection device. The injection deice or simulated injection device may include a drug container and a plunger disposed at least partially within drug container The plunger may be moveable with respect to the drug container from an initial position to a final position during operation of the injection device or simulated injection device. The system may further include a force sensor coupled with the plunger and configured to output a force signal when a user applies a force to the plunger to operate the injection device orsimulated injection device to perform or simulate a drug injection. Additionally, the system may include an end-of-injection sensor coupled with the drug container and configured to output an end-of-injection signal when the plunger is in the final position.

[0009] A further aspect of the present disclosure provides a system including a simulated injection device comprising a drug container and a plunger disposed at least partially within the drug container, the plunger being coupled with (e g , fixedly coupled with) the drug container such that the plunger does not move with respect to the container when a user applies a force to the plunger to simulate a drug injection. The system may further include a force sensor coupled with the plunger and configured to output a force signal when the user applies the force to the plunger to simulate a 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 couple the removable cap to the monitoring system. Furthermore, the monitoring system may include a torque sensor configured to output a torque signal when a user rotates or attempts to rotate the removable cap to remove the removable cap from the simulated portion of the injection device.

[0011] An additional aspect of the present disclosure provides a method of monitoring a removable cap coupled with a simulated portion of an injection device. The method may include receiving, from or via a torque sensor, a torque signal when a user rotates or attempts to rotate the removable cap to remove the removable cap from the simulated portion of the injection device; and / or determining, from at least the torque signal, at least one parameter relating to the removal or attempted removal, by the user, of the removable cap from the simulated portion of the injection device.

[0012] A further aspect of the present disclosure provides 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 disposed at least partially within a drug container of the drug delivery device. The proximal end of the plunger may include a press surface configured to facilitate application of a distally directed force to the plunger during operation of the drug delivery device. The proximal end of the plunger may additionally include an anti-slip member extending in a proximal direction from the press surface and configured to facilitate measuring a length of the plunger between the press surface and another portion of the plunger such as a portion of the distal end of the plungerBRIEF DESCRIPTION OF THE DRAWINGS

[0013] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily drawn to scale

[0014] Fig 1 is a perspective view of an exemplary injection device in accordance with various embodiments.

[0015] Fig 2 illustrates an exemplary monitoring system for an injection device in accordance with various embodiments

[0016] Fig 3 depicts another exemplary monitoring system for an injection device in accordance with various embodiments.

[0017] Fig 4 illustrates another view of the exemplary monitoring system for an injection device shown in Fig. 3.

[0018] Fig 5 depicts another exemplary monitoring system for an injection device in accordance with various embodiments.

[0019] Fig 6 illustrates an exemplary monitoring system for a simulated portion of an injection device in accordance with various embodiments

[0020] Fig 7 illustrates the exemplary monitoring system for a simulated portion of an injection device of Fig. 6 in use by a user.

[0021] Fig 8 illustrates a graph of a torque-time profile outputted by the exemplary monitoring system for a simulated portion of an injection device of Fig 6.

[0022] Fig 9 illustrates another exemplary monitoring system for a simulated injection device in accordance with various embodiments.

[0023] Fig 10 illustrates a cross-sectional view taken along the longitudinal axis A of the simulated injection device in Fig. 9.

[0024] Fig 11 illustrates another exemplary monitoring system for a simulated injection device in accordance with various embodiments.

[0025] Fig 12 illustrates a cross-sectional view taken along the longitudinal axis A of a drug container of the simulated injection device in Fig. 11.

[0026] Fig 13 illustrates another exemplary monitoring system for a simulated injection device in accordance with various embodiments.

[0027] Fig 14 illustrates a side view of an exemplary plunger for a drug delivery device in accordance with various embodiments.

[0028] Fig 15 illustrates a cross-sectional view taken along the longitudinal axis B of the plunger in Fig. 14.

[0029] Fig 16 illustrates a top view of a proximal end of the plunger in Fig. 14.DETAILED DESCRIPTION

[0030] The present disclosure generally pertains to systems and methods for monitoring one or more parameters relating to a user having to 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, such as a syringe, including but not limited to a standard syringe, a prefilled syringe, a Luer Lock syringe, a safety syringe, and similar variations. The user can be any individual including, for example, a healthcare professional such as a doctor or nurse or a layperson such as the patient Embodiments of the monitoring system and methods disclosed herein may facilitate testing, including, for example, clinical trials, performed to evaluate the safety, effectiveness, efficacy, ergonomics, and the like of an injection device or a portion thereof. For example, the presently disclosed monitoring systems and methods may be useful in evaluating if the design, manufacture, and / or intended use of an injection device meets various human factors and / or regulatory requirements and / or standards, including, for example, limitations on an amount and / or duration of a force and / or torque that a user may be required to apply to the injection device in preparing or operating the injection device for drug delivery Furthermore, by utilizing one or more sensors and computing units to determine the one or more parameters relating to a user's preparation or operation of the injection device, the presently disclosed systems and methods may provide reliable, empirical information for guiding the development and / or use of the injection device. Moreover, the embodiments disclosed herein may be configured to monitor and measure parameters associated not only with active, functional injection devices but also simulated or dummy injection devices, which may or not be capable of administering a drug to a patient and / or which may be designed to facilitate various testing and / or training arrangements and / or objectives.

[0031] To provide context for the various embodiments of the monitoring systems and methods described further below, a non-limiting example of an injection device 10 for which the monitoring systems and methods may be used or configured to simulate will be described with reference to Fig. 1 . While the present example of the injection device 10 generally takes the form of a syringe, it should be noted that the monitoring systems and methods of the present disclosure are not limited to syringes and may be applied to other injection devices, including, for example, any injection device whose preparation and / or operation requires at least some manual intervention or action on behalf of a user.

[0032] Referring to Fig. 1, the injection device 10 may be configured for delivering a drug, which may also be referred to herein as a medicament or drug product, into, for example, subcutaneous tissue, ocular tissue, or other tissue or simulated tissue of a patient. The drug may be, but is not limited to, various biologies such as peptides, peptibodies, and / or antibodies. The drug may be in a fluid or liquid form, gelatin form, and / or powdered form, although the present disclosure is not limited to a particular formor state of the drug. The injection device 10 illustrated in Fig. 1 may be in its final assembled form and / or in a pre-delivery or storage state.

[0033] The injection device 10 may include a drug container 12 (depicted as being generally transparent in Fig. 1), a plunger 14, a stopper 16, a needle 18, and a flange extender 20 The drug container 12 may have a longitudinal axis A and a proximal end 12a and a distal end 12b arranged along the longitudinal axis A. The drug container 12 may include a barrel 24 having a generally cylindrical wall 26 defining, partially or entirely, an internal bore or reservoir 28. At least the wall 26 of the barrel 24 may 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 of or the entirety of the barrel 24 may have cross-sectional shape (e.g., in a plane perpendicular to the longitudinal axis A) that is generally circular or any other suitable shape.

[0034] In a storage state, the drug container 12 may be filled partially or entirely with a drug, or may be empty. In some embodiments, the drug container 12 may be prefilled with a drug, for example, by a manufacturer and / or other supplier, and shipped to the point-of-care ready or substantially ready for operation by the user. In certain such embodiments, the injection device 10 may to take the form of a prefilled syringe. In other embodiments, the injection device 10 may be provided to the user empty and the user may be required to fill the drug container 12 at the point-of-care, for example, 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 injection device 10 to perform an injection.

[0035] In some embodiments, a volume of the drug disposed in the drug container 12 of the injection device 10 may be equal to 0.5 mL, or equal to approximately (e.g., ±10%) 0.5 mL, or equal to 1 mL, or equal to approximately (e.g , ±10%) 1 mL, or equal to 2 25 mL, or equal to approximately (e g , ±10%) 2 25 mL, or equal to 3 mL, or equal to approximately (e g , ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 1 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g., ±10%) 10 mL, or within a range between approximately (e.g, ±10%) 0.5 - 10 mL, or within a range between approximately (e.g, ±10%) 0.5 - 5 mL, or within a range between approximately (e.g, ±10%) 0.5 - 4 mL, or within a range between approximately (e.g, ±10%) 0.5 - 3 mL, or within a range between approximately (e.g, ±10%) 0.5 - 2.25 mL.

[0036] 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, a needle 18 may be fixedly coupled with the distal end 12b of the drug container 12 and / or in fluid communication with the reservoir 28 via the distal axial opening 30. A proximal end 18a of the needle 18 may be adhered, staked, or otherwise rigidly mechanically connected to, or integrally formed with, the wall 26 of the barrel 24 such that the needle 18 cannot move with respect to the wall 26 of the barrel 24. A distal end 18b of the needle 18 may include a sharpened tip or other pointed geometry allowing the distal end 18b of the needle 18 to pierce and / or penetrate through a patient’s skin, subcutaneous tissue, ocular tissue, and / or other tissue of the patient. The needle 18 may be hollow and / or include an axial passage that is parallel to and / or coaxial with the longitudinal axis A of the drug container 12. One or more openings may be formed in the distal end 18b of the needle 18 to allow drug to flow out of the needle 18 into the patient during operation of the injection device 10. The needle 18 may be made of metal, plastic, and / or any other suitably rigid material. Prior to use, the distal end 18b of the needle 18 may be covered with a removable sterile barrier (not shown in Fig. 1) such as, for example, a rigid needle shield (RNS) or a non-rigid needle shield (nRNS). The removable sterile barrier may be configured to protect the needle 18 from contaminants in an external or ambient environment prior to operation of the injection device 10. The user may be required to remove the removable sterile barrier from the needle 18 prior to operating the injection device 10 to perform a drug injection In alternative embodiments, the needle 18 may be omitted or atleast not initially coupled with the drug container 12. In such alternative embodiments, the distal end 12b of the drug container 12 may be coupled with and / or form a nozzle or other fluid path member including, for example, a male or female Luer Lock fitting.

[0037] 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 such that the flange 34 and the wall 26 define a single, unitary structure; or, alternatively, the flange 34 and the wall 26 of the barrel 24 may be separate structures which are rigidly coupled with each other. The flange 34 may generally extend in a radially outwardly direction with respect to the longitudinal axis A of the barrel 24 The flange 34 may extend completely or partially around the barrel 24. In some embodiments, two or more distinct barrel flanges may extend radially outwardly from respective portions of the wall 26 of the barrel 24 In some embodiments, the flange 34 may be configured to prevent the injection device 10 from inadvertently rolling across a flat surface when lying on its side.

[0038] The stopper 16 may be moveably disposed within the barrel 24 of the drug container 12 such that it can move in at least a distal direction 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 Proximal movement of the stopper 16 along the longitudinal axis A may also be possible in at least some embodiments. The stopper 16 may be constructed of an elastic material such as rubber or any other suitable material or combination of materials. The stopper 16 may slidably and / or sealingly contact an interior surface of the wall 26 of the barrel 24 such that, for example, the drug in the reservoir 28 is prevented or inhibited from leaking past the stopper 16 when the stopper 16 moves in the distal direction As an example, the stopper 16 may form a fluid-tight seal with the interior surface of the wall 26 of the barrel 24. Distal movement of the stopper 16 may expel the drug from the reservoir 28 and into and out through the needle 18

[0039] The plunger 14 may extend through an opening 26 in the proximal end 12a of the drug container 12 such that a distal end 14b of the plunger 14 is disposed at least partially within the drug container 12 and a proximal end 14a of the plunger 14 is disposed at least partially outside of the drug container 12 The distal end 14b of the plunger 14 may be coupled with a proximal end of the stopper 16. In some embodiments, this coupling may be achieved via one or more threaded surfaces Generally, the plunger 14 may be configured to allow a user to manually or semi-manually move the stopper 16 in the distal and / or proximal direction along the longitudinal axis A. As an example, the plunger 14 may have a longitudinal axis that is 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 may correspond to a plunger flange, allowing a user to press his or her thumb against a proximally facing surface 40a of the thumb rest 40 to push the plunger 14, and thereby the stopper 16, in the distal direction along the longitudinal axis A to expel the drug from the reservoir 28 through the needle 18 and into, for example, the patient’s tissue. The thumb rest 40 may include a distally facing surface 40b, which, as described below, may be used in sensing and determining an end-of-injection state of the injection device 10.

[0040] In embodiments where the drug container 12 is provided empty to the user and the user is require to draw drug from a vial or other external drug storage container into the reservoir 28 of the drug container 12, a user may pull up on the thumb rest 40 in the proximal direct, thereby moving the stopper 16 in a proximal direction along the longitudinal axis A. This action may create a vacuum capable of suctioning the drug into the reservoir 28 via, for example, the needle 18. As seen in Fig. 1 , the thumb rest 40 may be configured as a flange which extends radially outwardly with respect to a portion of the plunger 14 immediately adjacent to the thumb rest 40

[0041] With continued reference to Fig. 1, the flange extender 20 may be coupled with the flange 34 of the drug container 12. The flange extender 20 may be an accessory or add-on component which initially is separate from the injection device 10 and subsequently coupled with the flange 34 prior to operating the injection device 10 to deliver a drug to the patient. As an example, a user of the injection device 10 may be responsible for coupling the flange extender 20 with the flange 34 of the drug container 12 prior to operation. In alternative embodiments, the flange extender 20 may be omitted.

[0042] The flange extender 20 may be configured to facilitate a user’s grip of the drug container 12 during, for example, operation of the injection device 10 to deliver a drug to a patient. The flange extender 20 generally serves to extend the radial length of the flange 34 of the drug container 12 and thereby increase the surface area available for one or more of the user’s fingers to press against while, for example, the user presses his or her thumb against the proximal end 14a of plunger 14 As an example, the user may press his or her index finger and / or middle finger against the flange extender 20 to apply one or more proximally directed forces to the flange extender 20 while simultaneously pressing his or her thumb of the same hand against the thumb rest 40 of the plunger 14 to apply a distally directed force to the plunger 14. In some embodiments, the user may press one or more of their fingers (instead of or in addition to their thumb) against the thumb rest 40 to apply the distally directed force to the plunger 14 In certain such embodiments, to grip the flange extender 20, the user may employ their thumb and / or one or more of their fingers not pressing on the thumb rest 40.

[0043] At least a portion of the flange extender 20, when coupled with the drug container 12, may extend in a generally radially outwardly direction with respect to the longitudinal axis A of the barrel 24 The flange 34 may extend completely or partially around the barrel 24.

[0044] Furthermore, the flange extender 20 may include one or more generally distally facing surfaces 20a and 20b for contacting one or more fingers of the user during operation of the injection device 10 to perform an injection of a drug. As an example, the user may press one or more of his or her fingers against the distally facing exterior surface 20a and 20b of the flange extender 20, thereby applying generally proximally directed force(s) to the distally facing exterior surfaces 20a and 20b of the flange extender 20 during operation of the injection device 10 to perform the injection. Generally, the distally facing exterior surface 20a and 20b of the flange extender 20 may be configured such that the mechanics of the force(s) applied by the user to the flange extender 20 facilitate an efficient transfer force from the plunger 14 into motion of the stopper 16 to expel the drug from the injection device 10 (e g., motion of the stopper 16 in the distal direction along the longitudinal axis A). As an example, the distally facing exterior surfaces 20a and 20b of the flange extender 20 may be configured to prevent or inhibit the user’s finger(s) from slipping in the radial and / or axial direction(s), thereby maintaining the finger(s) at respective mechanically desirable location(s) (e.g., a desired radial distance measured from the longitudinal axis A). Additionally or alternatively, the distally facing exterior surface 20a and 20b of the flange extender 20 may be configured to apply reaction force(s) to the user’s finger(s) in a mechanically desirable direction (e.g., in a direction parallel or substantially parallel to the longitudinal axis A). In facilitating an efficient transfer of user applied force(s) into motion of the stopper 16, the flange extender 20 may reduce or minimize force loss(es) as compared to conventional syringes and / or make the injection device 10 easier and / or less cumbersome to operate for the user.

[0045] According to at least some embodiments, operating the injection device 10 to inject a drug may involve a user (who may be the patient) initially removing, if included, an RNS or other protective element covering the needle 18, inserting the distal end of the needle 18 into the patient’s tissue at a desired injection site, pushing the plunger 14 in the distal direction to expel a desired amount of, or all of, the drug in the drug container 12 out through the needle 18 into the patient’s tissue, removing the needle 18 from the injection site, and, if the injection device 10 is intended for single use, disposing the injection device 10 in, for example, a sharps container. In some embodiments, pushing the plunger 14 in the distal direction to expel the drug from the injection device 10 may involve moving the plunger 14 with respect to the drug container 12 from an initial position, such as that shown in Fig. 1 , where the distally facing surface 40b of the thumb rest 40 is spaced from a proximally facing surface 20c of the flange extender 20 by a first axial distance, to a final position where the distally facing surface 40b of the thumb rest 40 is spaced from a proximally facing surface 20c of the flange extender 20 by a second axial distance which is less than the first axial distance. In some embodiments, the distally facing surface 40b of the thumb rest 40 may contact, or being disposed immediately adjacent to, the proximally facing surface 20c of the flange extender 20 in the final position, such that the second axial distance is zero or a few millimeters. When the plunger 14 is in the final position, this may correspond to, in some embodiments, an end-of-injection state of the injection device 10, where all of or substantially all of the drug, or an intended amount or dose of the drug, has been expelled from the injection device 10.

[0046] Fig 2 illustrates an embodiment of a monitoring system 50 for an injection device including, for example, the injection device 10 and / or a simulated version thereof The monitoring system 50 generally may be configured to sense, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) relating to an injection device, including, for example, a user’s operation of the injection device or simulated injection device to perform or simulate a drug injection Pursuantly, the present embodiment of the monitoring system 50 may include a force sensor 52, an end-of-injection 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 end-of-injection sensor 54, and the computing unit 56, and / or include additional sensor(s) and / or computing unit(s) In some embodiments, the computing unit 56 may be omitted.

[0047] The force sensor 52 may be any device which senses or detects an amount of force or load applied to and / or experienced by the force sensor 52 and / or a structure coupled with the force sensor 52 In some embodiments, the force sensor 52 may include a load cell (e.g., a compressive load cell, a subminiature compressive load cell, and / or any other suitable load cell), a strain gauge, a pressure transducer, and / or any other device configured to convert mechanical force into an electrical and / or other computer-readable signal. The force sensor 52 may be configured such that when a force is applied to the plunger 14, including, for example, a distally directed force applied by a user to move or attempt to move the plunger 14 in a distal direction during an injection or simulated injection, the force sensor 52 outputs an electrical or other computer-readable signal (also referred to herein as a "force signal") representative of, for example, the magnitude of the applied force The force sensor 52 may be configured to output this signal to the computing unit 56 over the duration of the applied force, such that variations (or the lack thereof) in the magnitude of the applied force over time can be monitored and analyzed by the computing unit 56.

[0048] In some embodiments, the force sensor 52 may be coupled with (e.g., directly coupled with) the plunger 14 such that a force applied to the plunger 14, or at least a distally and / or proximally directed force applied to the plunger 14 in a direction parallel or substantially parallel to the longitudinal axis A, can be measured by the force sensor 52. In certain such embodiments, the force sensor 52 may be disposed on and / or adhered to a proximally facing exterior surface of the plunger 14, including, for example, the proximally facing surface 40a of thumb rest 40, as shown in Fig. 1, such that the force sensor 52 may be positioned axially between the user’s thumb and the thumb rest 40 when the user operates the injection device 10 or a simulated version thereof to perform or simulate a drug injection. As a result, the user’s thumb may directly contact the force sensor 52, or a housing containing the force sensor 52, when the user operates the injection device 10 or a simulated version thereof to perform or simulate the drug injection Having the user’s thumb directly contact or be positioned immediately adjacent to the force sensor 52 may, in at least some cases, improve the accuracy and / or reliability of the force sensor 52 in detecting the force applied by the user.

[0049] In some embodiments, instead of being disposed on an exterior surface of the plunger 14, the sensor 52 may be positioned partially or entirely within the plunger 14. In certain such embodiments, the sensor 52 may be positioned within the proximal end 14a of the plunger 14 or the distal end 14b of the plunger 14. Furthermore, in some embodiments, the force sensor 52 may be coupled with (e.g., directly coupled with) the stopper 16 as an alternative to, or in addition to, being coupled with the plunger 14.

[0050] The end-of-injection sensor 54 may be any device which senses or detects the plunger 14 in a position corresponding to the end-of-injection state of the injection device 10. In some embodiments, the end-of-injection sensor 54 may be configured to detect that the plunger 14 is in the final position, after the plunger 14 has been moved by the user from the initial position to the final position. As described above, when the plunger 14 is in the final position, the distally facing surface 40b of the thumb rest 40 may contact, or be disposed immediately adjacent to, the proximally facing surface 20c of the flange extender 20.

[0051] In some embodiments, the end-of-injection 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 and / or other computer-readable signal. The end-of-injection sensor 54 may be configured such that when the user has finished operating the injection device 10 or a simulated injection device to perform or simulate an injection and has moved the plunger 14 from its initial position to its final position, the end-of-injection sensor 54 outputs an electrical or other computer-readable signal (also referred to herein as an “end-of-injection signal”) indicating that the plunger 14 is in the final position. In some embodiments, the signal output by the end-of-injection sensor 54 may not indicate the progress of the plunger 14 in moving from the initial position to the final position but rather indicate only that the plunger 14 is in the final position (when that happens). In other embodiments, the signal output by the end-of-injection sensor 54 may indicate the progress of the plunger 14 in moving from the initial position to the final position.

[0052] In some embodiments, the end-of-injection sensor 54 may be coupled with (e g., directly coupled with) the flange extender 20, the proximal end 12a of the drug container 12 (including, for example, the flange 34), and / or any other portion of the injection device 10 which contacts or is immediately adjacent to a portion of the plunger 14 when the plunger 14 is in the final position but not the initial position. In some embodiments, the end-of-injection sensor 54 may be disposed on and / or adhered to the proximally facing surface 20c of the flange extender 20, as shown in Fig. 2. Furthermore, in some embodiments, the end-of- injection sensor 54 may be aligned with at least a portion of the thumb rest 40 of the plunger 14, such that when the plunger 14 is in the final position the at least a portion of the thumb rest 40 contacts or is immediately adjacent to the end-of-injection sensor 54. To achieve this positioning, a radial distance between the end-of-injection sensor 54 and the longitudinal axis A may be equal to or less than a radial distance between a radially outermost portion of the thumb rest 40 and the longitudinal axis A. The plunger 14 being in contact with or immediately adjacent to the end-of-injection sensor 54 may cause the end-of-injection sensor 54 to output an end-of-injection signal to at least the computing unit 56.

[0053] The computing unit 56 generally may be configured to receive signal(s) outputted or transmitted from any one or combination of the force sensor 52, the end-of-injection sensor 54, other sensor(s), and other device(s), and process (e.g., analyze, compare, evaluate, etc.) those signal(s) to determine one or more parameters relating to a user’s preparation and / or operation of the injection device 10 or a simulated version thereof to, for example, perform or simulate a drug injection. The computing unit 56 may perform these functions in real-time, or substantially in real-time, while, for example, a user prepares and / or operates the injection device 10 or simulated injection device to, for example, perform or simulate a drug injection.

[0054] In some embodiments, the computing unit 56 may take the form of a general purpose or special purpose 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 some combination thereof. The computing unit 56 may be a standalone device or may be integrated into the injection device 10, the force sensor 52, or the end- of-injection sensor 54, or may be distributed across multiple of these or other devices. In some embodiments, the computing unit 56 may be an electrical device (e.g., a hard-wired 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-transitory computer-readable instructions to be executed by a processor of a computer on which the program module is installed.

[0055] Referring to Fig. 2, in some embodiments, the computing unit 56 may include any one or combination of at least: a processor 60 (e.g., a microprocessor), a sensor interface 62, a program memory 64, a user interface 66, a network interface 68,a user interface 68, a monitored parameters memory 70, and a system bus enabling one or more of the elements of the computing unit 56 to communicate with one or more of other elements of the computing unit 56.

[0056] The sensor interface 62 may be configured for wired and / or wireless (e g., Bluetooth) communications with the force sensor 52, the end-of-injection sensor 54, and / or other sensors In some embodiments, the sensor interface 62 may include an analog-to-digital converter configured to convert analog signal(s) received from the force sensor 52, the end-of-injection sensor 54, and / or other sensors into digital signals for processing by the processor 60.

[0057] The program memory 64 may include a non-transitory computer-readable storage medium configured to store data, including, for example, non-transitory computer-readable instructions constituting of one or more services or programs and any data operated on or produced by such services or programs. The program memory 64 may store the data on a volatile (e g., RAM) and / or non-volatile memory (e.g., a hard disk), and may be a removable or non-removable memory. The monitored parameters memory 70 may be configured in a similar manner as the program memory 64 and may be part of or separate from the program memory 64. In some embodiments, the monitored parameters memory 70 may be implemented in a local and / or remote memory in accordance with any suitable data storage techniques (e.g., as a relational database).

[0058] The processor 60 may be configured to fetch and execute the instructions stored in the program memory 64 in order to perform various functions of the methods disclosed herein, including, for example, determining from signal(s) received from one or more of the sensors one or more parameters relating to the user’s preparation and / or operation of an injection device or a simulated injection device to, for example, perform or simulate a drug injection. In some embodiments, one or more processors in addition to the processor 60 may be included in the computing unit 56.

[0059] The user interface 66 may include any one or combination of at least: graphical display(s) (e g , an LED monitor, a touchscreen, etc.), input unit(s) (e.g., a keypad, a keyboard, buttons, knobs, etc.), light(s), and speaker(s). In some embodiments, executing the instructions stored in the program memory 64 may cause the processor 60 to control the user interface 66 to display visual representation (e.g., graphs, charts, tables, text, infographics, symbols, colored and / or flashing lights, etc.) and / or a sound indicative of, for example, the one or more parameters determined by the computing unit 56 relating to the user’s preparation and / or operation of the injection device 10 or a simulated injection device to, for example, perform or simulate a drug injection.

[0060] The network interface 68 may be configured to establish communication with external devices via a network (e g., the Internet) and may include an antenna for wireless communications, a port for a wired connection, a connection to a modem, a connection to a router (e.g., a wireless router), or some combination thereof.

[0061] In some embodiments, the monitoring system 50 may include an oscilloscope, which is separate from or integrated into the computing unit 56. The oscilloscope may be coupled with the force sensor 52, the end-of-injection sensor 54, and / or other sensors, and may generate a real-time, or substantially in real-time, display of the shape, amplitude, frequency, and / or other characteristics of the signal(s) outputted by the sensor(s).

[0062] In some embodiments, a monitoring module 72 may be stored in the program memory 64 as a set of instructions executable on the processor 60 and / or other processor(s). The monitoring module 72 may receive and process, via, for example, the processor 60, one or more of the force signal outputted by the force sensor 52, the end-of-injection signal 54 outputted by the end-of-injection sensor 54, and / or other signal(s) outputted from other sensor(s) or device(s) to determine and / or generate data representative of one or more parameters relating to a user’s preparation and / or operation of the injection device 10 or a simulated injection device to, for example, perform or simulate a drug injection. In some embodiments, the monitoring module 72 may generate graphs, charts, tables, infographics, symbols, text, and / or other visual representations of the data for display via a screen or monitor included in the user interface 66. Furthermore, in some embodiments, the monitoring module 72 may store (e.g., record) the data it generates in the monitored parameters memory 70

[0063] The one or more parameters determined by the monitoring module 72 and / or another element of the computing unit 56 may include any one or combination of at least the following: (a) a length of time needed for the user to operate the injection device 10 or a simulated injection device to complete or substantially complete an injection of a drug; (b) a force-time profile of a force applied by the user to the plunger 14 of the injection device 10 or simulated injection device when operating the injection device 10 or simulated injection device to perform or simulate a drug injection; (c) a time when the drug injection begins; (d) a time when the drug injection is complete or substantially complete; and (e) a maximum, minimum, and / or average force applied by the user to the plunger 14 of the injection device 10 or simulated injection device when operating the injection device 10 or simulated injection device to perform or simulate a drug injection.

[0064] In some embodiments, the monitoring module 72 and / or another element of the computing unit 56 may determine the length of time needed for the user to operate the injection device 10 or a simulated injection device to complete or substantially complete an injection of the drug by processing (e g., analyzing, comparing, evaluating, etc ) both the force signal from the force sensor 52 and the end-of-injection signal from the end-of-injection sensor 54. In certain such embodiments, the 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 end-of-injection signal is received from the end-of-injection signal 54, and calculating an amount of time between these two events. In alternative embodiments, the monitoring module 72 and / or another element of the computing unit 56 may determine the length of time needed for the user to operate the injection device 10 or a simulated injection device to complete or substantially complete an injection of the drug by analyzing solely the force signal from the force sensor 52. In some embodiments, the length of time needed for the user to operate the injection device 10 or a simulated injection device may correspond to an amount of time needed for the user to move the plunger 14 from the initial position to the final position

[0065] In some embodiments, the monitoring module 72 and / or another element of the computing unit 56 may be configured to generate a graph plotting the force-time profile of the force applied by the user to the plunger 14 of the injection device 10 or simulated injection device when operating the injection device 10 or simulated injection device to perform or simulate a drug injection. This graph may include the force measured in Newtons (or another unit of measurement used to quantify force) on the vertical or “y” axis and time in seconds (or another unit of measurement used to quantify time) on the horizontal or “x” axis. In some embodiments, the user interface 66 may display this graph on a screen or monitor.

[0066] In some embodiments, the monitoring module 72 and / or another element of the computing unit 56 may determine the time when the drug injection 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 another element of the computing unit 56 may determine the time when the drug injection begins without input from any sensor other than the force sensor 52 In some embodiments, the time when the drug injection begins may correspond to a time when the plunger 14 begins to move in the distal direction with respect to the drug container 12 as a result of, for example, the user applying a distally directed force to the plunger 14.

[0067] In some embodiments, the time when the drug injection is complete or substantially complete may correspond to a time when the plunger 14: is in the final position as indicated by or extrapolated from the end-of-injection signal from the end-of- injection sensor 54, subjected to little or no force by a user as indicated by or extrapolated from the force signal from the force sensor 52, and / or has ceased moving in the distal direction with respect to the drug container 12 as indicated by or extrapolated from the force signal from the force sensor 52.

[0068] Monitoring a user's operation of the injection device 10 or a simulated injection device to, for example, perform or simulate a drug injection may involve one or more of the following steps. As a preliminary step, unless already completed by a manufacturer or other entity or individual, a user may couple the force sensor 52 with the thumb rest 40 or another portion of the plunger 14, couple the end-of-injection sensor 54 with the flange extender 20 and / or the drug container 12, and / or couple the force sensor 52 and / or end-of-injection sensor 54 with the sensor interface 62 of the computing unit 56. Additionally, as apreliminary step if not already completed by a manufacturer or other entity or individual, the user may fill the reservoir 28 of the drug container 12 to a desired level with a drug. Next, the user may insert the distal end 18b of the needle 18 into a patient’s tissue or a simulated tissue and apply a distally directed force to the plunger 14 to cause the plunger 14, and thus also the stopper 16, to move in the distal direction from the initial position to the final position, thereby expelling the drug from the drug container 12 and out through the needle 18 into the patient’s tissue or simulated tissue. At least while the plunger 14 moves from the initial position to the final position, the force sensor 52 may output the force signal, and the sensor interface 62 of the computing unit 56 may directly or indirectly receive the force signal from the force sensor 52. When the plunger 14 moves into its final position, the end-of-injection sensor 54 may output the end-of-injection signal, and the sensor interface 62 of the computing unit 56 may directly or indirectly receive the end-of-injection signal from the end-of-injection sensor 54 Based on an analysis, comparison, evaluation, and / or other processing of any one or combination of the force signal, the end-of-injection signal, other sensor signal(s), and pre-stored information in the program memory 64, the monitoring module 72 of the computing unit 56 may determine any one or combination of the above-described parameters and / or other data relating to the user’s operation of the injection device 10 or simulated injection device to perform or simulate the drug injection. Once determined, the one or more parameters and / or other data may be stored in, for example, the monitored parameters memory 70 Additionally, or alternatively, the program memory 64 and / or another element of the computing unit 56 may generate one or more visual and / or audio indication(s) of the one or more parameters and / or other data and output those indication(s) via, for example, the user interface 66 of the computing unit 56 for consumption by the user and / or another individual(s).

[0069] While the foregoing monitoring system 50 and related method are described in connection with monitoring the preparation and / or operation of the injection device 10 or a simulated version thereof, the monitoring system 50 and related method can be used for monitoring the preparation and / or operation of other injection devices and simulated versions thereof. Other such injection devices include, for example, a Luer Lock syringe, a safety syringe, and similar variations, and simulated versions thereof.

[0070] Figs. 3 and 4 illustrate another embodiment of an injection device, designated with reference numeral 110, whose preparation and / or operation by a user can be monitored by the monitoring system 50 and related method described above. Various features of the injection device 110 in Figs. 3 and 4 may be similar or identical in structure, configuration, and / or function to features of the injection device 10 described above in conjunction with Figs. 1 and 2. Such features are assigned with the same reference numeral as used in Figs. 1 and 2, except incremented by 100. A description of some of these features is abbreviated or eliminated in the interest of conciseness.

[0071] The injection device 110 generally takes the form of a Luer Lock syringe (also referred to as a Luer Lok syringe) Unlike the injection device 10, the injection device 110, when in the storage state, may not have a needle coupled with the distal end 112b of the drug container 112. Instead, the distal end 112b of the drug container 112 may have a Luer Lock connector member 180 which, in the storage state, is coupled with and partially or entirely covered by a removable cap 182, as seen in Fig. 2. In some embodiments, the removable cap 182 may be configured to protect the distal end 112 of the drug container, for example, by sealingly engage the Luer Lock connector member 180 so as to prevent er inhibit the ingress of contaminants into the drug container 112 via the Luer Lock connector member 180. Prior to using the injection device 110 to perform an injection, the user may remove the removable cap 182 from the Luer Lock connector member 180 to expose the Luer Lock connector member 180 and subsequently couple a needle having a Luer Lock hub (not illustrated) to the Luer Lock connector member 180.

[0072] In some embodiments, the removable cap 182 may have a male fitting with an external thread and the Luer Lock connector member 180 may have a female fitting with an internal thread configured to threadably engage the internal thread, or vice versa. The external thread of the male fitting may threadably engage the internal thread of the female fitting such that the removable cap 182 can be screwed into / onto and / or out of / off of the Luer Lock connector member 180, for example, by the user of the injection device 110 In some embodiments, the user may remove the removable cap 182 by rotating the removable cap182 with respect to the drug container 112 and / or pulling the removable cap 182 in the proximal direction. In some embodiments, an 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 which sealingly engages an external surface of a 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 Luer Lock connector member 180 may resist rotation of the removable cap 182 when a user attempts to screw off or otherwise remove the removable cap 182 from the drug container 112. In some embodiments, after removing the removable cap 182, a user may couple a needle having 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.

[0073] As seen in Figs. 3 and 4, a force sensor 152 and / or an end-of-injection sensor 154 may be coupled with the injection device 110. The force sensor 152 and end-of-injection sensor 154 may be similar or identical in structure, configuration, and / or function to, respectively, the force sensor 52 and an end-of-injection sensor 54 described above in conjunction with the injection device 10. Furthermore, the force sensor 152 and end-of-injection sensor 154 may be coupled with and output signals to the monitoring system 50 or a similar system, which may then process those signal(s) in a similar or identical manner as described above with respect to the processing of the signals output by, respectively, the force sensor 52 and end-of-injection sensor 54, in order to determine one or more parameters relating to a user’s operation of the injection device 110 or a simulated version thereof to perform or simulate a drug injection.

[0074] Fig 5 illustrates an implementation of the injection device 110 where an external clip 190 is used to couple the end-of- injection sensor 154 to the flange extender 120 The external clip 190 may facilitate positioning the end-of-injection sensor 154 with respect to the plunger 114 such that the thumb rest 140 of the plunger 140 reliably or consistently contacts, or is positioned immediately adjacent to, the end-of-injection sensor 154 when the plunger 114 is in the final position As seen in Fig. 5, the external clip 190 may be disposed on the proximally facing surface 120c of the flange extender 120 and may be configured to grasp or otherwise clip onto the outer edge of the flange extender 120 The end-of-injection sensor 154 may be adhered to or otherwise coupled to the proximally facing surface of the external clip 190. In some embodiments, the external clip 190 may position the end-of-injection sensor 154 such that a radial distance between the end-of-injection sensor 154 and the longitudinal axis A may be equal to or less than a radial distance between a radially outermost portion of the thumb rest 140 and the longitudinal axis A

[0075] While the foregoing embodiments primarily concern monitoring a user's operation of an injection device to move a plunger to expel a drug from the injection device or simulating this act, other embodiments of the present disclosure, including those described below, relate to monitoring other user interactions with an injection device or a simulated injection device, including, for example, a user’s preparation of an injection device or simulated portion thereof for later use in a drug injection and / or a user’s operation of a simulated injection device having modified plunger which is configured such that, for example, the modified plunger does not move with respect to a drug container when pressed upon by the user.

[0076] Fig 6 illustrates an embodiment of a monitoring system 200 including a simulated portion of an injection device 220. The simulated portion of an injection device 220 may be configured to simulate, for example, the above-described drug container 112 of the injection device 110 or at least the distal end 112b of the drug container 112 of the injection device 110 As an example, the simulated portion of an injection device 220 may include the same or similar dimensions, features, geometry, and / or other physical and / or functional characteristics as the drug container 112 of the injection device 110 or at least the distal end 112b thereof. The monitoring system 200 generally may be configured to sense, measure, determine, analyze, store, and / or output one or more parameters (e.g. , physical properties, conditions, states, and / or characteristics) relating to a user’s manual interaction(s) with the simulated portion of an injection device 220 and / or component(s) coupled with the simulated portion of an injection device 220. In some embodiments, including the Fig. 6 embodiment, the monitoring system 200 may be configured tosense, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) relating to a user’s removal of a removable cap, including, for example, the above-described removable cap 182, which is coupled with the simulated portion of an injection device 220 in a manner simulating the above-described coupling between the removable cap 182 and the distal end 112 of the drug container 112 in the storage state of the injection device 110. Pursuant to these aims, the present 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 sensor(s) and / or computing unit(s).

[0077] In embodiments where the simulated portion of an injection device 220 is configured to simulate the distal end 112b of the drug container 112 of the injection device 110, such as the embodiment illustrated in Fig. 6, the simulated portion of an injection device 220, or a portion thereof, may have a cylindrical or substantially cylindrical shape and / or have an outer diameter that is the same or substantially the same as the outer diameter of at least a portion of the distal end 112b of the drug container 112 of the injection device 110. Furthermore, in such embodiments, the distal end of the simulated portion of an injection device 220 may have a threaded inner surface (e g., a threaded surface facing radially inwardly toward a longitudinal axis) simulating or corresponding to the threaded inner surface of the Luer Lock connector member 180 of the distal end 112b of the drug container 112 of the injection device 110. Accordingly, the removable cap 182 may be coupled with (e g., screwed into) and / or de-coupled from (e.g., screwed out of) the simulated portion of an injection device 220 in the same manner or a similar manner as how the removable cap 182 is coupled with and / or de-coupled from the Luer Lock connector member 180 of the distal end 112b of the drug container 112 of the injection device 110.

[0078] The torque sensor 252 may be any device which senses or detects an amount of torque applied to or experienced by the torque sensor 252 and / or a structure coupled with 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 and / or other computer-readable signal. The torque sensor 252 may be configured such that when a torque is applied to the simulated portion of an injection device 220, including, for example, as a result of a torque applied to the removable cap 182 coupled with the simulated portion of an injection device 220, the torque sensor 252 outputs an electrical or other computer- readable signal (also referred to herein as a “torque signal”) representative of, for example, the magnitude of the applied torque. The torque sensor 252 may be configured to output this signal to the computing unit 256 over the duration of the applied torque, such that variations (or the lack thereof) in the magnitude of the applied torque over time can be monitored and analyzed by the computing unit 256.

[0079] In some embodiments, the torque sensor 252 may be coupled with (e.g., directly coupled with) the simulated portion of an injection device 220 such that a torque applied to the simulated portion of an injection device 220, including, for example, a torque applied via the removable cap 182 coupled with the simulated portion of an injection device 220, can be measured by the torque sensor 252 In some embodiments, the torque sensor 252 may be configured to detect a torque having an axis of rotation that is parallel to and / or coaxial with a longitudinal axis of the simulated portion of an injection device 220 (including, e.g., a longitudinal axis which simulates or corresponds to the longitudinal axis A of the injection device 110). In some embodiments, as shown in Fig. 6, the torque sensor 252 may be coupled with an end of the simulated portion of an injection device 220 which simulates or corresponds to the proximal end 112a of the drug container 112 of the injection device 110. Furthermore, as seen in Fig. 6, in some embodiments, the torque sensor 252 may be contained partially or entirely within a sensor housing 224, and the sensor housing 224 may be removably coupled with a fixture stand 226. During use or testing, the torque sensor 252 and its housing 224 may be de-coupled from the fixture stand 226, as seen in Fig 7.

[0080] In some embodiments, the torque sensor 252 may be disposed on an exterior surface of the simulated portion of an injection device 220; whereas, in other embodiments, the torque sensor 252 may be disposed partially or entirely disposed within, or otherwise integrated into, the simulated portion of an injection device 220.

[0081] In some embodiments, the torque sensor 252 may be rotationally locked with respect to the simulated portion of an injection device 220 such that, when the user rotates or attempts to rotate the removable cap 182 to remove the removable cap 182 from the simulated portion of an injection device 220, the simulated portion of an injection device 220 does not rotate with respect to the torque sensor 252

[0082] In some embodiments, the monitoring system 200 may include a signal conditioner 228 coupled with the torque sensor 252 and / or the computing unit 256. The signal conditioner 228 may be configured to process and / or modify the torque signal output by the torque sensor 222 and / or other signals to make them suitable for further processing by the computing unit 256, including, for example, filtering and / or removing noise from the signal(s), amplifying the signal(s), and / or converting the signal(s) from one form to another form

[0083] The computing unit 256 generally may be configured to receive signal(s) outputted or transmitted from any one or combination of the torque sensor 252, other sensor(s), and other device(s), and process (e g., analyze, compare, evaluate, etc.) those signal(s) to determine one or more parameters relating to a user’s preparation and / or operation of the simulated portion of an injection device 220 to, for example, perform or simulate a drug injection. The computing unit 256 may perform these functions in real-time, or substantially in real-time, while, for example, a user prepares and / or operates the simulated portion of an injection device 220 or simulated injection device to, for example, perform or simulate a drug injection.

[0084] In some embodiments, the computing unit 256 may include similar or identical features as the computing unit 56. The description below of the computing unit 256 primarily focuses on differences between the computing unit 256 and the computing unit 56.

[0085] In some embodiments, a monitoring module may be stored in a program memory of the computing unit 256 as a set of instructions executable on a processor of the computing unit 256 and / or other processor(s). The monitoring module may receive and process, via, for example, the mentioned processor(s), the torque signal outputted from the torque sensor 252 and / or signals from other sensor(s) and / or device(s) to determine and / or generate data representative of one or more parameters relating to a user's preparation and / or operation of the simulated portion of an injection device 220 to, for example, perform or simulate a drug injection. In some embodiments, the monitoring module of the computing unit 256 may generate graphs, charts, tables, infographics, symbols, text, and / or other visual representations of the data for display via a screen or monitor included in a user interface included in the computing unit 256. Furthermore, in some embodiments, the monitoring module of the computing unit 256 may store (e.g. , record) the data it generates in a monitored parameters memory included in the computing unit 256.

[0086] The one or more parameters determined by the computing unit 256 may include any one or combination of at least the following: (a) a torque-time profile of a torque applied by the user to the simulated portion of an injection device 220 when removing or attempting to remove the removable cap 182 from the simulated portion of an injection device 220; (b) a maximum torque applied by the user to the simulated portion of an injection device 220 when removing or attempting to remove the removable cap 182 from the simulated portion of an injection device 220; (c) an average maximum torque applied by the user to the simulated portion of an injection device 220 over a selected time period when removing or attempting to remove the removable cap 182 from the simulated portion of an injection device 220; and (d) a length of time needed for the user to remove or substantially remove the removable cap 182 from the simulated portion of an injection device 220. In some embodiments, any one or combination of these parameters and / or other parameter(s) may be analyzed to determine or investigate, for example: limit(s) of the strength of a user and / or the strength of a target user population in removing the removable cap 182 from the injection device 110; and / or a minimum user strength needed for removing the removable cap 182 from the injection device 110.

[0087] In some embodiments, the computing unit 256 may be configured to generate a graph plotting the torque-time profile of the torque applied by the user to the simulated portion of an injection device 200 when removing or attempting to remove the removable cap 182 from the simulated portion of an injection device 220. This graph may include the torque measured in Newton-meters (or another unit of measurement used to quantify torque) on the vertical or “y” axis and time in seconds (oranother unit of measurement used to quantify time) on the horizontal or “x” axis Fig. 8 illustrates 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

[0088] Monitoring a user’s removal or attempted removal of the removable cap 182 from the simulated portion of an injection device 220 may involve one or more of the following steps. As a preliminary step, a user may couple the torque sensor 252 with a sensor interface and / or other element of the computing unit 256. Next, as seen in Fig. 7, the user may grasp the removable cap 182 with one or their hands and, with the other one of their hands, grasp the simulated portion of an injection device 220. The user may then rotate or attempt to rotate the removable cap 182 with respect to the simulated portion of an injection device 220 to, for example, screw the removable cap 182 off of or otherwise remove or de-couple the removable cap 182 from the simulated portion of an injection device 220 At least while the user rotates or attempts to rotate the removable cap 182 with respect to the simulated portion of an injection device 220, the torque sensor 252 may output the torque signal, and a sensor interface of the computing unit 256 may directly or indirectly receive the torque signal from the torque sensor 252. Based on an analysis, comparison, evaluation, and / or other processing of any one or combination of the torque signal, other sensor signal(s), and pre-stored information in a memory of the computing unit 256, a program memory and / or other element of the computing unit 256 may determine any one or combination of the above-described parameters and / or other data relating to the user’s removal or attempted removal of the removable cap 182 from the simulated portion of an injection device 220. Once determined, the one or more parameters and / or other data may be stored in, for example, the monitored parameters memory of the computing unit 256. Additionally, or alternatively, a program memory and / or another element of the computing unit 256 may generate one or more visual and / or audio indication(s) of the one or more parameters and / or other data and output those indication(s) via, for example, a user interface of the computing unit 256 for consumption by the user and / or another individual(s). In some embodiments, such an indication may be the graph illustrated in Fig 8

[0089] Figs. 9-12 illustrate embodiments relating to monitoring a user’s operation of a simulated injection device having modified plunger which may be configured such that, for example, the modified plunger does not move with respect to a drug container when pressed upon by the user. These embodiments facilitate, for example, measuring one or more parameters relating to a user’s operation of an injection device at one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect to the drug container.

[0090] Figs. 9 and 10 illustrate a simulated injection device 310 which is generally configured to simulate an injection device, including, for example, the above-described injection device 10, to the extent the injection device has a plunger which is fixed (e.g., fixed immovably) in a final position corresponding to, for example, an end-of-injection state, or, alternatively, is fixed (e.g., fixed immovably) in an initial position corresponding to, for example, a minimum or low fill volume of a drug container. The simulated injection device 310 may include a drug container 312 (shown as being generally transparent in Fig. 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 or identical in structure, configuration, and / or function to, respectively, the above-described drug container 12, plunger 14, needle 18, and flange extender 20, except for at least the following differences.

[0091] The drug container 312 may not be filled or fillable with a drug and / or at least a portion of (or the entirety 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, the distal end 312b of the drug container 312 may include at least one proximally facing inner surface 312c which is disposed proximal to the neck or tip 312d of the drug container 312, as seen in Figs. 9 and 10. The proximally facing inner surface 312c of the drug container 312 may be configured to engage and / or couple with a distally facing surface 314c of the plunger 314 such that the plunger 312 is prevented, or selectively prevented, from moving in the distal direction and / or the proximal direction with respect to the drug container 312 when a user applies a distally and / or proximally directed force to the plunger 314.

[0092] In some embodiments, an axial distance X1 between the proximally facing inner surface 312c of the drug container 312 and a proximally facing exterior end surface 312e of the drug container 312 may be selected such that, when the distally facing end surface 314c of the plunger 314 engages or contacts the proximally facing inner surface 312c of the drug container 312, the axial distance X2 between a proximally facing surface 340a of a thumb rest 340 of the plunger 314 and the proximally facing exterior end surface 312e of the drug container 312 corresponds to (e g., is equal to or substantially equal to) an axial distance between similar surfaces of a real injection device (e g., the injection device 10 and / or another device which the simulated injection device 310 is intended to simulate) when the real injection device is in the end-of-injection state (e g., when the plunger of the real injection device is in its final position) and / or when the real injection device is in a storage state (e.g., when the plunger of the real injection device is in an initial position) and / or filled with a minimum or low volume of a drug (e.g., a minimum dosage of a drug).

[0093] In some embodiments, the needle 318 may be a simulated needle, including, for example, a simulated needle which is made from plastic and / or has a blunt and / or non-sharpened distal tip. In certain such embodiments, the simulated needle may be configured to mimic or otherwise simulate the fluidic resistance of a real needle Furthermore, in some embodiments, the needle 318 may be omitted.

[0094] Fig 9 shows that the simulated injection device 310 may be coupled with, or part of, a monitoring system 350. The monitoring system 350 generally may be configured to sense, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) relating to a user’s manual interaction(s) with the simulated injection device 310 and / or component(s) coupled with the simulated injection device 310. In some embodiments, the monitoring system 350 may be configured to sense, measure, determine, analyze, store, and / or output one or more parameters (e.g., physical properties, conditions, states, and / or characteristics) relating to a user’s attempt to move the plunger 314 in the distal direction with respect to the drug container 312. Pursuantly, the present embodiment of the monitoring system 350 may include a force sensor 322 and / or a computing unit 356, and / or include additional sensor(s) and / or computing unit(s)

[0095] The force sensor 352 may be any device which senses or detects an amount of force or load applied to and / or experienced by the force sensor 352 and / or a structure coupled with the force sensor 352. In some embodiments, the force sensor 352 may include a load cell (e.g., a compressive load cell, a subminiature compressive load cell, and / or any other suitable load cell), a strain gauge, a pressure transducer, and / or any other device configured to convert mechanical force into an electrical and / or other computer-readable signal. The force sensor 352 may be configured such that when a force is applied to the plunger 314, including, for example, a distally directed force applied by a user to move or attempt to move the plunger 314 in a distal direction during an injection or simulated injection, the force sensor 352 outputs an electrical or other computer-readable signal (also referred to herein as a “force signal”) representative of, for example, the magnitude of the applied force. The force sensor 352 may be configured to output this signal to the computing unit 356 over the duration of the applied force, such that variations (or the lack thereof) in the magnitude of the applied force over time can be monitored and analyzed by the computing unit 356.

[0096] In some embodiments, the force sensor 352 may be coupled with (e g., directly coupled with) the plunger 314 such that a force applied to the plunger 314, or at least a distally and / or proximally directed force 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 disposed at least partially within the plunger 314 (as seen in Fig. 10) or disposed entirely within the plunger 314. In other embodiments, the force sensor 352 may be disposed on and / or adhered to a proximally facing exterior surface of the plunger 314, including, for example, the proximally facing surface 340a of thumb rest 340.

[0097] The computing unit 356 generally may be configured to receive signal(s) outputted or transmitted from any one or combination of the force sensor 352, other sensor(s), and other device(s), and process (e.g., analyze, compare, evaluate, etc.) those signal(s) to determine one or more parameters relating to a user’s handling of the simulated injection device 310 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plungerand / or stopper with respect to the drug container The computing unit 356 may perform these functions in real-time, or substantially in real-time, while, for example, a user uses the simulated injection device 310.

[0098] In some embodiments, the computing unit 356 may include similar or identical features as the computing unit 56. The description below of the computing unit 356 primarily focuses on differences between the computing unit 356 and the computing unit 56. In some embodiments, a monitoring module may be stored in a program memory of the computing unit 356 as a set of instructions executable on a processor of the computing unit 356 and / or other processor(s). The monitoring module may receive and process, via, for example, the mentioned processor(s), the force signal outputted from the force sensor 352 and / or signals from other sensor(s) and / or device(s) to determine and / or generate data representative of one or more parameters relating to the user’s handling of the simulated injection device 310 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect 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 of the data for display via a screen or monitor included in a user interface included in the computing unit 356. Furthermore, in some embodiments, the monitoring module of the computing unit 356 may store (e g., record) the data it generates in a monitored parameters memory included in the computing unit 356.

[0099] The one or more parameters determined by the computing unit 356 may include any one or combination of at least the following: (a) a force-time profile of a force applied by the user to plunger 314 when attempting to move the plunger 314 with respect to the container 312; (b) a maximum length of time that a user is able to apply a force to plunger 314 when attempting to move the plunger 314 with respect to the container 312; and (c) a maximum, minimum, and / or average force applied by the user to the plunger 314 when attempting to move the plunger 314 with respect to the container 312 In some embodiments, any one or combination of these parameters and / or other parameter(s) may be analyzed to determine, for example, limit(s) of the strength of a user and / or the strength of a target user population in operating a real injection device which the simulated injection device 310 may be configured to simulate.

[0100] Monitoring a user's handling of the simulated injection device 310 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect to the drug container, may involve one or more of the following steps. As a preliminary step, a user may couple the force sensor 222 with a sensor interface and / or other element of the computing unit 356 and / or coupled the force sensor 222 with the plunger 314 of the simulated injection device 310 Next, the user may apply a distally directed force to the plunger 314 in an attempt to cause the plunger 314 to move in the distal direction with respect to the drug container 312 However, the plunger 314 may not move with respect to the drug container 312, due to the contact between the distally facing surface 314c of the plunger 314 and the proximally facing inner surface 312c of the drug container 312 and / or other fixed connection between the plunger 314 and the drug container 312. At least while the user applies the distally directed force to the plunger 314, the force sensor 352 may output the force signal, and a sensor interface of the computing unit 356 may directly or indirectly receive the force signal from the force sensor 352. Based on an analysis, comparison, evaluation, and / or other processing of any one or combination of the force signal, other sensor signal(s), and pre-stored information in a program memory of the computing unit 356, a monitoring module of the computing unit 356 may determine any one or combination of the above-described parameters and / or other data relating to the user’s handling of the simulated injection device 310 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect to the drug container. Once determined, the one or more parameters and / or other data may be stored in, for example, a monitored parameters memory of the computing unit 356. Additionally, or alternatively, a program memory and / or another element of the computing unit 356 may generate one or more visual and / or audio indication(s) of the one or more parameters and / or other data and output those indication(s) via, for example, a user interface of the computing unit 356 for consumption by the user and / or another individual(s).

[0101] Figs. 11 and 12 illustrate another embodiment of a simulated injection device, designated with reference numeral 410, whose preparation and / or operation by a user can be monitored by the monitoring system 350 and related method described above. Various features of the injection device 410 in Figs. 11 and 12 may be similar or identical in structure, configuration, and / or function to features of the simulated injection device 310 described above in conjunction with Figs 9 and 10 Such features are assigned with the same reference numeral as used in Figs 9 and 10, except incremented by 100. A description of some of these features is abbreviated or eliminated in the interest of conciseness.

[0102] The simulated injection device 410 generally is configured to simulate an injection device, including, for example, the above-described injection device 10, to the extent the injection device has a plunger which is fixed (e.g., fixed immovably) in an initial position corresponding to, for example, a storage state and / or a maximum or high fill volume of a 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, plunger 414, needle 418, and flange extender 420 may be similar or identical in structure, configuration, and / or function to, respectively, the above-described drug container 312, plunger 314, needle 318, and flange extender 320, except for at least the following differences.

[0103] The axial distance X3 between the proximally facing inner surface 412c of the drug container 412 and a proximally facing exterior end surface 412e of the drug container 412 may be selected such that, when the distally facing end surface of the plunger 414 engages or contacts the proximally facing inner surface 412c of the drug container 412, the axial distance between a proximally facing surface 440a of a thumb rest 440 of the plunger 414 and the proximally facing exterior end surface of the drug container 412 corresponds to (e.g., is equal to or substantially equal to) an axial distance between similar surfaces of a real injection device (e g , the injection device 10 and / or another device which the simulated injection device 410 is intended to simulate) when the real injection device is in the storage state (e.g., when the plunger of the real injection device is in its initial position) and / or when the real injection filled with a maximum or high volume of a drug (e.g., a maximum dosage of a drug). The axial distance X3 may be less than the axial distance X1 .

[0104] Monitoring a user's handling of the simulated injection device 410 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect to the drug container, may involve one or more of the steps or similar steps as those described above with respect to monitoring the simulated injection device 310 via the monitoring system 350.

[0105] Fig 13 illustrates an additional embodiment of a simulated injection device, designated with reference numeral 510, whose preparation and / or operation by a user can be monitored by the monitoring system 350 and related method described above. Various features of the injection device 510 in Fig. 13 may be similar or identical in structure, configuration, and / or function to features of the simulated injection device 410 described above in conjunction with Figs 11 and 12. Such features are assigned with the same reference numeral as used in Figs. 11 and 12, except incremented by 200. A description of some of these features is abbreviated or eliminated in the interest of conciseness

[0106] The simulated injection device 510 generally is configured to simulate a safety syringe, to the extent the safety syringe has a plunger which is fixed (e.g., fixed immovably) in an initial position corresponding to, for example, a storage state and / or a maximum or high fill volume of a drug container. In alternative embodiments, the simulated injection device 510 generally may be configured to simulate a safety syringe, to the extent the safety syringe has a plunger which is fixed (e.g , fixed immovably) in a final position corresponding to, for example, an end-of-injection state, or, alternatively, is fixed (e.g., fixed immovably) in an initial position corresponding to, for example, a minimum or low fill volume of a 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 or identical in structure, configuration, and / or function to, respectively, the above-described drug container 412, plunger 414, needle 418, and flange extender 420, except for at least the following differences.

[0107] The simulated injection device 510 may include a needle cover 590 configured to simulate a needle cover which selectively moves with respect to the needle 518 to, for example, cover the needle 518 when or if the plunger 514 is in the final position and / or end-of-injection state. In some embodiments, the needle cover 590 may move and otherwise function in a similar manner as the needle cover it is intended to simulate; whereas, in other embodiments, the needle cover 590 may be fixedly coupled (e g., immovably coupled) to the drug container 514 such that the needle cover 590 does not move with respect to the needle 518 during use of the simulated injection device 510.

[0108] Furthermore, in some embodiments, the simulated injection device 510 may include a spring-biased mechanism 592 configured to simulate a spring-biased mechanism which automatically moves the needle cover 590 to cover the needle 518 when or if the plunger 514 is in the final position and / or end-of-injection state In some embodiments, the spring-biased mechanism 592 may automatically move needle cover 590 and otherwise function in a similar manner as the spring-biased mechanism it is intended to simulate; whereas, in other embodiments, the spring-biased mechanism 592 may be prevented (e.g., via a fixed coupling with the drug container 512) from automatically moving the needle cover 590 to cover the needle 518.

[0109] In some embodiments, such as the one illustrated in Fig. 13, the force sensor 352 may be disposed on and / or coupled with a proximal end of the plunger 514 such that a user’s thumb may directly contact the force sensor 352, or a housing containing the force sensor 352, when the user handles the simulated injection device 510 to simulate a drug injection. In other embodiments, the force sensor 352 may be disposed at least partially within the plunger 514, similar to, for example, the arrangement shown in Fig 10.

[0110] Monitoring a user's handling of the simulated injection device 510 to, for example, simulate one or more specific stages of operation, moments in time during operation, and axial positions of the plunger and / or stopper with respect to the drug container, may involve one or more of the steps or similar steps as those described above with respect to monitoring the simulated injection device 310 and / or simulated injection device 410 via the monitoring system 350.

[0111] In some embodiments, the force sensor 352 and / or another force sensor(s) may be configured to sense or detect the force applied by the user to activate (e.g., release) the spring-biased mechanism 592 so that the spring-biased mechanism 592 automatically moves the needle cover 590 to cover the needle 518 at, for example, the end of an injection Additionally or alternatively, the force sensor 352 and / or other force sensor(s) may be configured to sense or detect any potential force applied to and / or felt by the user as a result of (e.g., caused by) the activation of the spring-biased mechanism 592 and / or its operation.

[0112] Figs. 14-16 illustrate an embodiment of a plunger, designated with reference numeral 614, for expelling a drug from a drug delivery device, including, for example, a syringe. The plunger 614 may be used with any of the systems, devices, and methods described above, including, for example, being used as a substitute for the plunger 14 of the injection device 10.Various features of the plunger in Figs. 14-16 may be similar or identical in structure, configuration, and / or function to features of the plunger 14 described above in conjunction with Figs. 1 and 2 Such features are assigned with the same reference numeral as used in Figs. 1 and 2, except incremented by 600. A description of some of these features is abbreviated or eliminated in the interest of conciseness.

[0113] It may be useful or even essential in certain instances to measure the length of a plunger prior to use. For example, verifying the accuracy of a plunger's length may be necessary to ensure that the plunger can travel a required distance within a barrel of a syringe to expel a prescribed amount of a drug from the syringe. Particularly in medical applications where precise dosages are needed for patient safety, it may be necessary to measure and confirm the length of the plunger prior to use The measurement may be performed by, for example, a manufacturer as part of a quality control process and / or by a user of the plunger Furthermore, ensuring that a plunger is of standardized length may in certain cases allow it to be interchangeable between different syringe brands and models. The plunger 614 illustrated in Figs. 14-16 is configured to facilitate such a measurement of its length.

[0114] The plunger 614 may extend along a longitudinal axis B and have proximal end 614a and a distal end 614b. At least the distal end 614b may be configured to be disposed at least partially within a drug container of a drug delivery device, including, for example, the drug container 12 of the injection device 10. The distal end 614b may include a threaded portion 680 configured to threadably engage a stopper including, for example, the stopper 16

[0115] The proximal end 614a of the plunger 614 generally may be configured to allow a user and / or machine to apply a distally directed force to the plunger 614 to, for example, move the plunger 614 through the drug container during operation of the drug delivery device In some embodiments, the proximal end 614a of the plunger 614 may include a press surface 682 configured to facilitate the application of the distally directed force to the plunger 614 during operation of the drug delivery device. The press surface 682 may be planar or substantially planar and face in the proximal direction or substantially in the proximal direction. Furthermore, in some embodiments, the press surface 682 may define at least a portion of an outermost peripheral edge 683 of the proximal end 614a of the plunger 614. In some embodiments, the outermost peripheral edge 683 may correspond to a radially outermost peripheral edge of the proximal end 614a of the plunger 614

[0116] In some embodiments, the press surface 682 may correspond to a proximally facing surface of a thumb rest 640. The thumb rest 640 may be configured to allow a user to press his or her thumb against the plunger 614 and push it in the distal direction to expel a drug from a drug container during operation of the drug delivery device. The thumb rest 640 may have an enlarged cross section as compared to the distal end 614b of the plunger 614 and may include a radially outwardly extending flange 684 which overhangs a portion of the plunger 614 which is distal to the thumb rest 640. This configuration may enable the thumb rest 640 to provide an increased surface area for the user to place his or her thumb when pushing against the plunger 614.

[0117] The proximal end 614a of the plunger 614 may further include an anti-slip member 686 configured to prevent or inhibit lateral or radial movement of a thumb, finger, and / or other object with respect to the press surface 682 when applying a distally directed force to the press surface 682. In some embodiments, the anti-slip member 686 may extend in a proximal direction from the press surface 682. The anti-slip member 686 may include one or more protruding structures as seen in Figs. 14-16 and / or a texture applied to the press surface 682 or a portion thereof. In some embodiments, the anti-slip member 686 may define at least a portion of the outermost peripheral edge 683 of the proximal end 614a of the plunger 614

[0118] In some embodiments, the anti-slip member 686 may include a ring-shaped protrusion 688 extending in a proximal direction from the press surface 682. The ring-shaped protrusion 688, or a portion thereof, may have a radius of curvature similar to that of the outermost peripheral edge 683 of the proximal end 614a of the plunger 614. As described below, the ring-shaped protrusion 688 may include one or more openings such that its ring shape is not continuous in a circumferential direction but instead has one or more discontinuities in the circumferential direction

[0119] Due to its proximal extension from the press surface 682, the anti-slip member 686 may conceal the press surface 682 from view when the plunger 614 is viewed laterally from the side, depending on the location of the viewer As a result, measuring a length of the plunger 614, such as the length L in Fig. 14, between the press surface 682 and a portion of the distal end 614b of the plunger 614 may not be possible, or significantly complicated. For example, if a light beam aimed in a direction perpendicular to the longitudinal axis B is used to measure or identify the axial location of the press surface 682, the anti-slip member 686 potentially could obstruct the light beam (depending on the location of its source) and thereby potentially result in an inaccurate measurement of the axial location of the press surface 682 and / or the length L

[0120] To address this issue, the anti-slip member 686 may be configured to facilitate measuring a length of the plunger 614 between the press surface 682 and another portion 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, cut-outs, apertures,depressions, grooves, discontinuities, etc.) to facilitate visibility of the press surface 682, including, for example, when the press surface 682 is viewed laterally from the side, such as being viewed along a radial direction with respect to the longitudinal axis B As a more specific example, the one or more openings may be arranged such that: one or more first portions of the outermost peripheral edge 683 of the proximal end 614a of the plunger 614 is / are at least partially defined by the press surface 682; and one or more second portions of the outermost peripheral edge 683 of the proximal end 614a of the plunger 614 is / are at least partially defined by the anti-slip member 686. As an even more specific example, one or more pairs of openings may be formed in the anti-slip member 868, with the openings in each pair being spaced 180 degrees or approximately (e.g., ±10%) 180 degrees apart from each other in the circumferential direction around the proximal end 614a of the plunger 614. A pair of such openings may facilitate, for example, an optical based measurement of the length L by allowing a light beam to pass through the anti-slip member 686, which may, for example, assist in use of the light beam for identifying the location of the press surface 682.

[0121] Fig 16 shows that the ring-shaped protrusion 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 press surface 682 is not covered by the ring-shaped protrusion 688, and the second opening 692 is configured such that a second portion 682b of the press surface 682 is not covered by the ring-shaped protrusion 688. The first opening 690 and the second opening 692 may be spaced 180 degrees or approximately (e.g., ±10%) 180 degrees apart from each other in the circumferential direction around the proximal end 614a of the plunger 614. Other spacing of the first and second openings 690 and 692 is also possible In some embodiments, the first and second openings 690 and 692 may result in the ring-shaped protrusion 688 having the appearance of two C-shaped members when viewed from above, as seen in Fig. 16.

[0122] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.

[0123] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well

[0124] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0125] The drug will be contained in a reservoir In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0126] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF) Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim , 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)

[0127] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0128] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 ("IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti- IGF-1 R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal I gG2 antibodies, including but not limited to fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like;Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor;another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x 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 a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct

[0130] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0131] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

What is claimed is:

1. A monitoring system for an injection device or simulated injection device comprising a drug container and a plunger disposed at least partially within the drug container, the monitoring system comprising: a force sensor configured to output a force signal when a user applies a force to the plunger to operate the injection device or simulated injection device to perform or simulate a drug injection; and a computing unit configured to determine, from at least the force signal, at least one parameter relating to the operation of the injection device or simulated injection device by the user2. The monitoring system of claim 1, wherein the at least one parameter determined by the computing unit comprises a force-time profile of the force applied by the user to the plunger when operating the injection device or simulated injection device to perform or simulate the drug injection.

3. The monitoring system of claims 1 or 2, wherein the at least one parameter determined by the computing unit comprises a time when the user begins to perform or simulate the drug injection.

4. The monitoring system of claim 3, wherein the computing unit is configured to determine the time when the user begins to perform or simulate the drug injection without input from any sensor other than the force sensor5. The monitoring system of any one of claims 1 to 4, wherein the force sensor is configured to be coupled with the plunger6 The monitoring system of claim 5, wherein at least a portion of the force sensor is positionable between a thumb and / or finger of the user and a thumb rest of the plunger during operation of the injection device or simulated injection device.

7. The monitoring system of any one of claims 1 to 6, wherein the force sensor comprises a compressive load cell8. The monitoring system of any one of claims 1 to 7, wherein the force sensor is positionable at least partially within the plunger.

9. The monitoring system of any one of claims 1 to 8, comprising an end-of-injection sensor configured to output an end-of-injection signal when the user moves the plunger with respect to the drug container from an initial position to a final position during operation of the injection device or simulated injection device10. The monitoring system of claim 9, wherein the computing unit is configured to determine the at least one parameter by processing the force signal and the end-of-injection signal.11 The monitoring system of claim 10, wherein the at least one parameter determined by the computing unit comprises a length of time for the user to complete or substantially complete the drug injection using the injection device or simulated injection device.

12. The monitoring system of any one of claims 9 to 11 , wherein the computing unit is configured to determine the at least one parameter relating to operation of the injection device or simulated injection device from the end-of-injection signal, and the at least one parameter comprises a time when the drug injection is complete or substantially complete.

13. The monitoring system of any one of claims 9 to 12, comprising a flange extender coupled with the drug container, wherein the end-of-injection sensor is coupled with the flange extender.

14. The monitoring system of claim 13, comprising a clip configured to couple the end-of-injection sensor to the flange extender.

15. The monitoring system of any one of claims 9 to 14, wherein the end-of-injection sensor is positionable such that the end-of-injection sensor 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 of any one of claims 9 to 15, wherein the end-of-injection sensor comprises a touch sensor.

17. The monitoring system of claim 16, wherein the touch sensor is a piezoelectric touch sensor.18 The monitoring system of claims 1 to 17, comprising the injection device or simulated injection device, wherein at least a portion of the plunger is movably disposed within the drug container.

19. The monitoring system of claim 18, wherein the injection device or simulated injection device comprises a needle fixedly coupled with the drug container.

20. The monitoring system of claim 19, wherein the injection device or simulated injection device comprises a spring- biased mechanism configured to automatically cover the needle when the plunger is in the final position.21 . The monitoring system of any one of claims 18 to 20, wherein the injection device or simulated injection device is a prefilled syringe or simulated prefilled syringe.

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

23. The monitoring system of any one of claims 1 to 8, comprising the simulated injection device, wherein the plunger of the simulated injection device is coupled with the drug container of the simulated injection device such that the plunger of the simulated injection device does not move with respect to the drug container of the simulated injection device when the user applies the force to the plunger of the simulated injection device.

24. The monitoring system of claim 23, wherein the plunger is positioned with respect to the drug container to simulate at least one of: the drug container being filled with a drug to a maximum fill volume, and the plunger being in an initial position.

25. The monitoring system of any one of claims 23 or 24, wherein the plunger is positioned with respect to the drug container to simulate an end-of-injection state of the plunger.26 The monitoring system of any one of claims 23 to 25, wherein the simulated injection device comprises a needle or simulated needle fixedly coupled with the drug container.

27. The monitoring system of claim 26, wherein the simulated injection device is dimensioned to simulate a prefilled syringe.

28. The monitoring system of any one of claims 23 to 27, wherein the simulated injection device is dimensioned to simulate a safety syringe29. The monitoring system of any one of claims 23 to 28, wherein the simulated injection device is dimensioned to simulate a Luer Lock syringe30. A method of monitoring operation of an injection device or simulated injection device comprising a drug container and a plunger disposed at least partially within the drug container, the method comprising: receiving, from or via a force sensor, a force signal when a user applies a force to the plunger to operate the injection device or simulated injection device to perform or simulate a drug injection; and determining, from at least the force signal, at least one parameter relating to the operation of the injection device or simulated injection device by the user.31 . The method of claim 30, wherein the at least one parameter comprises a force-time profile of the force applied by the user to the plunger when operating the injection device or simulated injection device to perform or simulate the drug injection.

32. The method of claims 30 or 31, wherein the at least one parameter comprises a time when the user begins to perform or simulate the drug injection.

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

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

35. The method of claim 34, wherein determining the least one parameter relating to the operation of the injection device or simulated injection device comprises determining the least one parameter relating to the operation of the injection device or simulated injection device from processing the force signal and the end-of-injection signal.

36. The method of claim 35, wherein the at least one parameter comprises a length of time for the user to complete or substantially complete the drug injection when operating the injection device or simulated injection device.

37. The method of any one of claims 30 to 34, wherein the plunger is coupled with the drug container such that the plunger does not move with respect to the drug container when the user applies the force to the plunger.38 A system comprising: an injection device or simulated injection device comprising a drug container and a plunger disposed at least partially within drug container, the plunger being moveable with respect 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 coupled with the plunger and configured to output a force signal when a user applies a force to the plunger to operate the injection device or simulated injection device to perform or simulate a drug injection; and an end-of-injection sensor coupled with the drug container and configured to output an end-of-injection signal when the plunger is in the final position.

39. The system of claim 38, comprising a flange extender coupled with the drug container, wherein the end-of-injection sensor is disposed on the flange extender.

40. The system of claim 39, wherein the end-of-injection sensor is disposed on a proximally facing surface of the flange extender and contacts a distally facing surface of the plunger when the plunger is in the final position.41 The system of any one of claims 38 to 40, wherein the end-of-injection sensor comprises a touch sensor42. The system of any one of claims 38 to 41, wherein the force sensor comprises a compressive load cell.

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

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

45. The system of any one of claims 38 to 44, wherein the injection device or simulated injection device is a prefilled syringe or simulated prefilled syringe46. The system of any one of claims 38 to 45, wherein the injection device or simulated injection device is a safety syringe or simulated safety syringe.

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

48. A system comprising: a simulated injection device comprising a drug container and a plunger disposed at least partially within the drug container, the plunger being coupled with the drug container such that the plunger does not move with respect to the container when a user applies a force to the plunger to simulate a drug injection; anda force sensor coupled with the plunger and configured to output a force signal when the user applies the force to the plunger to simulate a drug injection.49 The system of claim 48, wherein the force sensor is disposed at least partially within the plunger50. The system of claims 48 or 49, wherein the plunger comprises a distal end and a proximal end, the distal end of the plunger is disposed at least partially within the drug container, the proximal end of the plunger comprises a thumb rest, and the force sensor is disposed on a proximally facing surface of the thumb rest.51 . The system of any one of claims 48 to 50, wherein the force sensor comprises a compressive load cell52. The system of any one of claims 48 to 51 , wherein the plunger is positioned with respect to the drug container to simulate at least one of: the drug container being filled with a drug to a maximum fill volume, and the plunger being in an initial position.

53. The system of any one of claims 48 to 52, wherein the plunger is positioned with respect to the drug container to simulate an end-of-injection state of the plunger.54 The system of any one of claims 48 to 53, wherein the simulated injection device is dimensioned to simulate a prefilled syringe.

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

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

57. A monitoring system for a removable cap of an injection device, the monitoring system comprising: a simulated portion of the injection device configured to couple the removable cap to the monitoring system; and a torque sensor configured to output a torque signal when a user rotates or attempts to rotate the removable cap to remove the removable cap from the simulated portion of the injection device.

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

59. The monitoring system of claim 58, wherein the at least one parameter determined by the computing unit comprises 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 device60. The monitoring system of claims 58 or 59, wherein the at least one parameter determined by the computing unit comprises a 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 of any one of claims 58 to 60, wherein the at least one parameter determined by the computing unit comprises an average maximum torque applied by the user over a selected time period when removing or attempting to remove the removable cap from the simulated portion of the injection device62. The monitoring system of any one of claims 58 to 61 , wherein the at least one parameter determined by the computing unit comprises a length of time for the user to remove or substantially remove the removable cap from the simulated portion of the injection device.

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

64. The monitoring system of any one of claims 57 to 63, wherein the torque sensor comprises a torque transducer65. The monitoring system of any one of claims 57 to 64, wherein the simulated portion of the injection device is rotationally locked with respect to torque sensor such that, when the user rotates or attempts to rotate the removable cap to remove the removable cap from the simulated portion of the injection device, the simulated portion of the injection device does not rotate with respect to the torque sensor.

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

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

68. The monitoring system of 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 coupled with the torque sensor, and the distal end is configured to couple the removable cap to the simulated portion of the injection device.

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

70. The monitoring system of claim 69, wherein the threaded surface of the distal end of the simulated portion of the injection device faces radially inwardly.71 . The monitoring system of any one of claims 68 to 70, comprising a housing, wherein the torque sensor and the proximal end of the simulated portion of the injection device are each disposed at least partially within the housing.

72. A method of monitoring a removable cap coupled with a simulated portion of an injection device, the method comprising: receiving, from or via a torque sensor, a torque signal when a user rotates or attempts to rotate the removable cap to remove the removable cap from the simulated portion of the injection device; and determining, from at least the torque signal, at least one parameter relating to the removal or attempted removal, by the user, of the removable cap from the simulated portion of the injection device.

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

74. The method of claims 73 or 73, wherein the at least one parameter comprises a torque-time profile of the toque applied by the user when removing or attempting to remove the removable cap from the simulated portion of the injection device75. The method of any one of claims 72 to 74, wherein the at least one parameter determined comprises a 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 of any one of claims 72 to 75, wherein the at least one parameter determined comprises an average maximum torque applied by the user over a selected time period when removing or attempting to remove the removable cap from the simulated portion of the injection device77. The method of any one of claims 72 to 76, wherein the at least one parameter determined comprises length of time for the user to remove or substantially remove the removable cap from the simulated portion of the injection device.

78. A plunger for a drug delivery device, the plunger comprising: a distal end configured to be disposed at least partially within a drug container of the drug delivery device; and a proximal end comprising: a press surface configured to facilitate application of a distally directed force to the plunger during operation of the drug delivery device; and an anti-slip member extending in a proximal direction from the press surface and configured to facilitate measuring a length of the plunger between the press surface and another portion of the plunger.

79. The plunger of claim 78, wherein the proximal end of the plunger comprises an outermost peripheral edge, wherein at least a first portion of the outermost peripheral edge is at least partially defined by the press surface and at least a second portion of the outermost peripheral edge is at least partially defined by the anti-slip member80. The plunger of any one of claims 78 or 79, wherein the anti-slip member comprises a ring-shaped protrusion extending in the proximal direction from the press surface.81 . The plunger of claim 80, wherein the ring-shaped protrusion at least partially defines an outermost peripheral edge of the proximal end of the plunger.

82. The plunger of any one of claims 80 or 81 , wherein the ring-shaped protrusion is discontinuous in a circumferential direction.

83. The plunger of any one of claims 80 to 82, wherein the ring-shaped protrusion comprises a first opening configured such that at least a first portion of the press surface is not covered by the ring-shaped protrusion.

84. The plunger of claim 83, wherein the ring-shaped protrusion comprises a second opening configured such that at least a second portion of the press surface is not covered by the ring-shaped protrusion.

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

86. The plunger of any one of claims 78 to 85, wherein the proximal end of the plunger comprises a thumb rest, and wherein a proximally facing surface of the thumb rest comprises the press surface.

87. The plunger of claim 86, wherein the thumb rest comprises a radially outwardly extending flange.

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