Status sensing system for a connected injection device

Abstract

A drug delivery system is configured to generate an indication about a skill level, familiarity, or experience of a user operating such a system. The system can include an injection barrel assembly, one or more skin contact sensors, and one or more injection barrel assembly sensors configured to detect initiation and / or completion of a dispensing event. The system can also include one or more processing circuits configured to measure a duration of time between when a skin contact sensor detects contact with skin tissue and when the injection barrel assembly initiates a dispensing event, compare the measured duration of time to a threshold duration of time, and generate a user indication signal if the measured duration of time exceeds the threshold duration of time.

Description

Technical Field

[0001] This disclosure relates to a drug delivery device, and more particularly to a status sensing system used in a connected drug delivery device. Background Technology

[0002] Injection devices in the form of syringes or including syringes are widely used by healthcare professionals and patients self-administering medications. Patients with a variety of different conditions often need to inject themselves with medications, and various devices have been developed to facilitate this self-administration. In one example, automated injection devices that include mechanisms that perform several steps in the injection process make self-administration more convenient for patients, especially those with limited hand dexterity. Automated injection devices are typically disposable devices that are discarded after use. Summary of the Invention

[0003] In some exemplary embodiments, a drug delivery system is provided, comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an injection cartridge assembly at least partially disposed within the internal volume, the injection cartridge assembly including a cartridge body configured to hold a drug and an injection needle extending from the cartridge body; a drive mechanism configured to initiate a dispensing event, in which the injection cartridge assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more injection cartridge assembly sensors disposed within the housing, configured to... The system comprises: outputting a syringe assembly sensor signal based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly; and one or more processing circuits configured to: determine when one or more skin contact sensors detect contact with skin tissue; determine when the syringe assembly initiates a dispensing event based at least in part on the syringe assembly sensor signal; measure a first duration between when one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates a dispensing event; compare the first duration with a first pre-programmed threshold duration; and generate a first user indication signal when the first duration is greater than the first threshold duration.

[0004] In some exemplary embodiments, a drug delivery system is provided, comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an injection cartridge assembly at least partially disposed within the internal volume, the injection cartridge assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a movable base cap configured to cover the opening; one or more injection cartridge assembly sensors configured to detect at least one of a position of at least a portion of the injection cartridge assembly and movement of at least a portion of the injection cartridge assembly; one or more base cap sensors configured to detect when the movable base cap has been removed from the opening; and one or more processing circuitry configured to: determine when the injection cartridge assembly initiates a dispensing event based on data output from the one or more injection cartridge assembly sensors; and generate a misuse indication signal when the one or more base cap sensors detect that the movable base cap has been removed from the opening and is then subsequently returned to its original position to cover the opening before the injection cartridge assembly initiates a dispensing event.

[0005] In some exemplary embodiments, a drug delivery system is provided, comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more syringe assembly sensors disposed within the housing, wherein... The system is configured to output a syringe assembly sensor signal based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly; and one or more processing circuits configured to: determine, at least in part based on the syringe assembly sensor signal, when the syringe assembly initiates a dispensing event; count the number of proximity events in which one or more skin contact sensors detect contact with skin tissue and then subsequently stop detecting contact with skin tissue before the syringe assembly initiates a dispensing event; compare the number of proximity events with a pre-programmed maximum threshold; and generate a user indication signal when the number of proximity events is greater than the pre-programmed maximum threshold.

[0006] In some exemplary embodiments, a drug delivery system is provided, comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an injection cartridge assembly at least partially disposed within the internal volume, the injection cartridge assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event in which the injection cartridge assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to output a skin detection signal when contact with skin tissue is detected; and one or more other sensors disposed within the housing. A plurality of syringe assembly sensors configured to output syringe assembly sensor signals based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly; and one or more processing circuits configured to: determine, at least in part based on the syringe assembly sensor signals, when the syringe assembly initiates a dispensing event and when the syringe assembly completes a dispensing event; process one or more skin detection signals received from one or more skin contact sensors after the dispensing event is initiated and before the dispensing event is completed to derive data indicating the continuity of skin contact during the dispensing event; and generate a user indication signal when the data meets one or more pre-programmed criteria.

[0007] In other exemplary embodiments, a drug delivery system is provided, comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an injection cartridge assembly at least partially disposed within the internal volume, the injection cartridge assembly including a cylinder configured to hold a drug and an injection needle extending from the cylinder; a movable base cap configured to cover the opening; one or more injection cartridge assembly sensors configured to detect at least one of a position of at least a portion of the injection cartridge assembly and movement of at least a portion of the injection cartridge assembly; one or more base cap sensors configured to detect when the movable base cap has moved from the opening; and one or more processing circuits configured to: determine when the movable base cap has been removed from the opening based on data output from the one or more base cap sensors; determine when the injection cartridge assembly initiates a dispensing event based on data output from the one or more injection cartridge assembly sensors; and generate a user instruction signal when the injection cartridge assembly does not initiate a dispensing event within a threshold time after the base cap has been removed from the opening. Attached Figure Description

[0008] The above and other features of this disclosure, and the ways in which they are implemented, will become more apparent from the following description, taken in conjunction with the accompanying drawings and reference to embodiments thereof, and the invention itself will be better understood, wherein:

[0009] Figure 1This is a cross-sectional view of the injection device before use.

[0010] Figure 2 This is a cross-sectional view of the injection device, showing the syringe assembly in its storage position and ready for dispensing events.

[0011] Figure 3 This is a cross-sectional view of the injection device, with the syringe assembly in the injection position.

[0012] Figure 4 This is a perspective view of the plunger.

[0013] Figure 5 This is a perspective view of the syringe holder.

[0014] Figure 6 This is a perspective view of the upper shuttle component.

[0015] Figure 7 This is a perspective view of the lower shuttle component.

[0016] Figure 8 This is a cross-sectional view of the injection apparatus according to the first embodiment, illustrating the placement of one or more main PCBs within the end portion of the housing of the injection apparatus.

[0017] Figure 9A It is a top (i.e., far-side) perspective view of the main PCB and sub-PCB according to the first set of embodiments.

[0018] Figure 9B This is a bottom (i.e., near-side) perspective view of the main PCB and sub-PCB of the first embodiment.

[0019] Figure 10A This is a top view of the main PCB and sub-PCB of the first embodiment.

[0020] Figure 10B This is a bottom view of the main PCB and sub-PCB of the first embodiment.

[0021] Figure 11 This is a cross-sectional side view of the injection device according to the first embodiment, and shows the spatial relationship between the magnet and the two magnetometers.

[0022] Figure 12 This is a system architecture view of the electrical components and external devices within the injection device according to the first set of embodiments.

[0023] Figure 13 This is a flowchart illustrating a process for “pairing” or establishing a communication session between an injection device and an external device, according to any of the first set of embodiments and any of the second and third sets of embodiments.

[0024] Figure 14A and14B A flowchart illustrating a process implemented by a mobile medical application running on an external device according to any of the first, second, and third sets of embodiments is depicted.

[0025] Figure 15 This is a schematic diagram for displaying the status of a skin contact sensor on a display of an external device.

[0026] Figure 16A , 16B 16C is a view of an alternative shape of the outwardly flared end portion of the injection device housing according to any of the first, second, and third sets of embodiments.

[0027] Figure 17A This is a top perspective view of the main PCB and the syringe position detector switch according to the second embodiment.

[0028] Figure 17B This is a bottom perspective view of the main PCB and the syringe position detector switch according to the second embodiment.

[0029] Figure 18A This is a top view of the main PCB and the syringe position detector switch according to the second embodiment.

[0030] Figure 18B This is a bottom view of the main PCB and the syringe position detector switch according to the second embodiment.

[0031] Figure 19 This is a side view of the injection device according to the second set of embodiments when the syringe assembly is in the storage position or the retracted position.

[0032] Figure 20 This is a side view of the injection device when the syringe assembly is in the injection position, according to the second embodiment.

[0033] Figure 21A This is a top perspective view of the main PCB according to the third embodiment.

[0034] Figure 21B This is a bottom perspective view of the main PCB according to the third embodiment.

[0035] Figure 22A This is a top view of the main PCB according to the third embodiment.

[0036] Figure 22B This is a bottom view of the main PCB according to the third embodiment.

[0037] Figure 23A and 23B This is a perspective view of the base cover with the sensor removed according to the third embodiment.

[0038] Figure 24A This is a perspective view of the main PCB and the base cover removal sensor associated with the removal of the end cap, according to a third embodiment.

[0039] Figure 24B This is a perspective view of the main PCB and the base cover removal sensor associated with the removal of the end cap, according to a third embodiment.

[0040] Figure 25A This is a side view of the base cover removing the sensor when the end cap is removed from the injection device, according to a third embodiment.

[0041] Figure 25B This is a side view showing the base cover removing the sensor when the end cap is attached to the injection device according to the third embodiment.

[0042] Figure 26 This is a graph illustrating an exemplary signal output from an accelerometer disposed on an injection device according to a third set of embodiments.

[0043] Figure 27 This is a system architecture view of the electrical components within the injection device according to the third embodiment.

[0044] Figure 28 This is a flowchart depicting an exemplary process implemented by the processing circuitry on the injection device according to a third set of embodiments.

[0045] Figure 29 This is a circuit diagram illustrating exemplary logic for determining whether an allocation event has been initiated and completed according to a third set of embodiments.

[0046] Figure 30 This is a flowchart describing an exemplary process for detecting the initiation and completion of an allocation event according to a third set of embodiments.

[0047] Figure 31 This is a flowchart depicting another exemplary process for detecting the initiation and completion of an allocation event according to a third set of embodiments.

[0048] Figure 32 This is a flowchart depicting yet another exemplary process for detecting the initiation and completion of an allocation event according to a third set of embodiments.

[0049] Figure 33 This is a flowchart depicting an exemplary process for detecting acceleration spikes according to a third set of embodiments.

[0050] Figure 34 An exemplary sequence of user steps for using the injection device according to any of the first, second, or third sets of embodiments is depicted.

[0051] Figure 35 This is a flowchart depicting an exemplary process for generating a user instruction if the user does not initiate an allocation event within a threshold time period after placing the device on the patient's body.

[0052] Figure 36 This is a flowchart depicting an exemplary process for generating a user instruction if the user does not remove the device from the patient's body within a threshold time for completing the assignment event.

[0053] Figure 37 This is a flowchart depicting an exemplary process for generating a misuse instruction that instructs the user to remove the base cover of the injection device and then return the base cover of the injection device to its original position without initiating and / or completing a dispensing event.

[0054] Figure 38 This is a flowchart depicting an exemplary process that generates a user instruction if a user places the device against a patient's body once or multiple times without initiating an allocation event.

[0055] Figure 39 A flowchart depicts an exemplary process of generating user instructions if the user removes the device from the patient's body while an assignment event is in progress.

[0056] Figure 40 This describes an exemplary process that generates a user instruction depending on whether the user initiates an assignment event within a certain threshold time after removing the base cover.

[0057] Throughout the views, corresponding reference numerals indicate the corresponding parts. Although the examples set forth herein illustrate embodiments of this disclosure in several forms, the embodiments disclosed below are not intended to be exhaustive or to be construed as limiting the scope of the invention to the precise forms disclosed. Detailed Implementation

[0058] This disclosure relates to a sensing system for a drug delivery device. The sensing system can be integrated within the delivery device or incorporated into a removable module attached to the delivery device. Such a sensing system can be configured to determine the current operating state of the device by sensing various parameters or signals representing the operating state of the device.

[0059] In some embodiments, the sensing system can sense the position or movement of a device component relative to other device components. For example, such a sensing system can track the position and / or movement of a plunger used to expel medication from a drug delivery device. By tracking the position or movement of the plunger, the drug delivery device can determine how much medication has been expelled, the rate at which the medication is expelled, and / or when the medication within the delivery device has been completely delivered. Such a sensing system can utilize various types of sensors, such as visual sensors that track the movement of the device components, optical or radiation sensors that detect when a device component enters or exits a target detection area of ​​the sensing system, magnetic field sensors that detect changes in the sensing magnetic field caused by the movement of the device components, or one or more accelerometers that detect the movement of the device components.

[0060] In some embodiments, the sensing system can determine the orientation of the device. The determined orientation can be used to determine whether the drug delivery device is correctly oriented to deliver the drug—for example, when the device is oriented upside down, or in any orientation that makes safe and reliable drug delivery difficult or impossible, the delivery device can warn its user or prevent drug delivery. Such a sensing system can utilize one or more accelerometers located at one or more sites on the device, the accelerometers being configured to determine the direction of gravity. The sensing system may also include processor circuitry configured to determine the orientation of the device about one, two, or three orientation axes based on readings from the accelerometers.

[0061] In some embodiments, the sensing system can measure the temperature of a drug stored within a drug delivery device. Some drugs may need to be stored in a first (e.g., lower) temperature range to avoid deterioration, but must reach a second (e.g., higher) temperature range before being delivered to a patient. The temperature sensing system can be used to monitor the temperature of the drug within the delivery device while it is being stored, ensuring that the drug is not exposed to unsafe temperatures that could render it unsuitable for ingestion. The temperature sensing system can also be used to warn the user when the drug temperature approaches an unsafe level. When the device is ready for use, the sensing system can be used to determine when the drug temperature has entered the second temperature range. The drug delivery device can then notify the user, for example, by using a visual indicator (e.g., by lighting and / or extinguishing one or more LEDs), an auditory indicator (e.g., a notification or sound output from a speaker), or a wireless signal transmitted to an external mobile device (which in turn notifies the user). Such a temperature sensing system can utilize any of a variety of sensors to measure the temperature of the drug, such as infrared sensors or thermistors.

[0062] In some embodiments, the sensing system may include one or more sensors configured to determine when and / or which parts of the drug delivery device come into contact with the patient's skin. The drug delivery device can use such a sensing system to determine when the device is correctly positioned to inject a drug into the patient. Such a sensing system may include one or more sensors configured to measure resistance or capacitance, and processing circuitry configured to determine when individual sensors come into contact with human tissue, such as skin, based on the measured resistance or capacitance. Where the sensing system includes multiple sensors, the system may be configured to determine which individual sensors among the multiple sensors are in contact with human tissue. Such a sensing system may also include temperature sensors, similar to those discussed above, configured to determine when sensors come into contact with human tissue.

[0063] The sensing system can determine the current operating state of the device. This current state can be communicated to the user, for example, via visual, auditory, or tactile indicators integrated with or physically attached to the delivery device, such as one or more displays, LEDs, speakers, or vibration motors. The current state can also be communicated to the user by sending data about the current state to an external device via a wired or wireless communication link—the external device can then communicate the current state to the user. For example, in some embodiments, the drug delivery device may include a short-range wireless communication interface, such as Near Field Communication (NFC), Bluetooth, and / or Bluetooth Low Energy (BLE) communication circuitry, which transmits data about the current operating state of the delivery device to an external device. This external device may be an electronic computing device configured to execute software and / or firmware to receive and process data and communicate the operating state of the delivery device to the user. Exemplary external devices include mobile handheld devices (e.g., smartphones, mobile phones, pagers, personal digital assistants (PDAs), tablets, etc.), wearable devices (e.g., smartwatches or augmented or virtual reality devices), portable general-purpose computers (e.g., laptops), or desktop general-purpose computers. When a user is notified of the device's operational status, they are less likely to take actions that could impair the device's effective use, such as removing the device from the injection site before drug delivery is complete, or delivering the drug before it has been heated to the appropriate delivery temperature. By way of illustration, the drug delivery device is described as being in the form of an auto-injector device. However, the drug delivery device can be any device used to deliver a drug dose, such as a pen syringe, infusion pump, and syringe. The drug can be of any type that can be delivered by such a drug delivery device.

[0064] Advantageously, a single sensing system positioned along the device can be provided to capture at least one of the following states: needle guard presence, injection preparation, needle insertion, drug delivery, and needle retraction, or any combination thereof. It can also be advantageous to use modules to determine whether a dose is delivered and / or the operational status during the injection process without altering the mechanical architecture of the delivery device's drive mechanism.

[0065] exist Figure 1-3 The present invention depicts a drug injection device 20 in various operational states. An example of such a device and its operation is described in U.S. Patent No. 8,734,394 B2 to Adams et al., issued May 24, 2014, the entire disclosure of which is incorporated herein by reference. Device 20 includes a syringe assembly 22, a drive mechanism 24, and a retraction mechanism 26, and may include one or more main printed circuit boards (PCBs) 82 and / or one or more secondary PCBs 84, as will be described later. Figure 8 , 9A As shown in 9B, 10A, and 10B, the syringe assembly 22 includes a barrel 30 and a piston 32. The barrel 30 forms a container body for holding a drug, and the piston 32 is disposed within the barrel 30 for driving the drug out of the barrel. The syringe assembly 22 also includes a needle assembly 33 having a hollow injection needle 34 and a needle holder 35 that mounts the needle 34 to the syringe barrel 30. The piston 32 is advanced within the barrel 30 toward the needle 34 to dispense the drug through the needle 34.

[0066] The device described herein (such as device 20) may also include a drug, such as, for example, within a syringe barrel 30. In another embodiment, the system may include one or more devices, including device 20 and a drug. The term “drug” or “medication product” refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists (such as dulaglutide or liraglutide), glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, gastric acid regulator analogs, gastric acid regulator derivatives, therapeutic antibodies, including but not limited to IL-23 antibody analogs or derivatives (such as mirikizumab, IL-17 antibody analogs or derivatives), therapeutic agents for pain-related treatment (such as galcanzeumab or lasmiditan), and any therapeutic agent capable of being delivered by the device described herein. The drug used in the device may be formulated with one or more excipients. The device is typically operated by a patient, caregiver, or healthcare professional in the manner described above to deliver the drug to a person.

[0067] Figure 1The diagram illustrates the device 20 in its initial configuration before use. Here, an end cap 36 is attached to the injection device housing 38 and covers the proximal opening 40 in the housing 38. As used herein, distal and proximal refer to the axial position relative to such an injection site when the device is oriented for use at such site; thus, for example, the proximal end of the housing refers to the housing end closest to such an injection site, and the distal end of the housing refers to the housing end furthest from such an injection site. The housing 38 may be formed of a plastic material and is shown extending generally longitudinally along the longitudinal axis 48 between the distal end immediately adjacent to the actuation button 52 and the proximal end immediately adjacent to the end opening 40. Figure 2 and Figure 8 As shown, the housing 38 may include a user-gripable portion 37 configured to be gripped by a user's hand, the user-gripable portion 37 extending radially outward from the longitudinal axis 48 by a distance 41. In some embodiments, the length of the radial distance 41 may be between 5 and 10 mm (e.g., in some embodiments, 5-8 mm may be a suitable length). Similarly, as... Figure 2 and Figure 8 As shown, the housing 38 may further include an outwardly flared end portion 39 adjacent to the proximal opening 40 at the proximal end of the housing. This end portion extends radially outward from the longitudinal axis 48 by a distance 43 greater than the radial distance 41. In some embodiments, the length of the radial distance 43 may be greater than 10 mm. For example, in some embodiments, the length of the radial distance 43 may be between 10 and 20 mm (e.g., in some embodiments, 15-20 mm may be a suitable length). Figure 1-3 As shown, the end portion 39 can be smoothly inclined radially outward from the user-gripable portion 37. In other embodiments, the end portion 39 may take the form of other shapes. Figure 16A -C illustrates several exemplary alternative shapes for the end portion 39, but the end portion 39 can take any shape that extends away from the longitudinal axis 48 by a radial distance 43 greater than the radial distance 41 of the user-gripable portion.

[0068] A needle protector 42 is mounted on the syringe assembly 22 and covers and surrounds the needle 34. The end cap 36 and needle protector 42 protect the user from accidental needle pricks and also protect the needle 34 from damage. When using the device 20 to dispense medication, for example, to inject medication into a patient, the end cap 36 and needle protector 42 are removed first. Figure 2 The illustration shows the device 20 after the end cap 36 and needle guard 42 have been removed from the syringe assembly 22, with the syringe assembly in a stored position and the device 20 ready to perform a dispensing event.

[0069] The syringe assembly 22 is movable relative to the injection device 20 between a storage position and an injection position. Figure 3The illustration shows that the syringe assembly 22 has been removed from the device 20. Figure 2 The device 20 shown is moved from its storage position to the injection position. At the storage position ( Figure 1 and 2 In the injection position, needle 34 retracts to a position where it is positioned within the housing 38 of device 20. Figure 3 In the case, the needle 34 protrudes outward from the housing 38 beyond the proximal opening 40 in a proximal direction parallel to the longitudinal axis 48, thereby allowing the needle 34 to be inserted into the patient's body.

[0070] The drive mechanism 24 includes a plunger 44 that engages the piston 32. The drive mechanism 24 also includes a spring 46 that drives the plunger 44 in a translating motion. In the illustrated embodiment, the spring 46 advances the plunger 44 along a linear path defined by the longitudinal axis 48 of the device 20. As the plunger 44 advances, the foot 50 of the plunger 44 contacts the piston 32. As the plunger 44 advances further, the syringe assembly 22 advances along axis 48 from its storage position to its injection position. After the syringe assembly 22 has advanced to its injection position, continued proximal advance of the plunger 44 causes the piston 32 within the syringe 30 from its initial piston position (e.g., ...). Figure 1 and 2 As shown) advances proximally to its final piston position (as shown) Figure 3 (As shown), so that medication is dispensed from needle 34 during a dispensing event. Before any medication dispensing, and while the syringe barrel 30 holds the full initial volume of medication, piston 32 will be in its initial piston position. After piston 32 has advanced its full stroke length toward needle assembly 33, piston 32 will be in its final piston position near needle assembly 33, and medication within the syringe barrel 30 will be expelled from the barrel. In a single use, syringe assembly 22 will hold a single dose of medication to be delivered in a single dispensing event, and in that single dispensing event, piston 32 will advance from its initial piston position to its final piston position, thereby delivering the full single dose contents of syringe assembly 22. Although the device is shown as a single-use device, multiple-use devices can also benefit from the status indication of the device during a single use.

[0071] Advancement of plunger 44 will generally not result in dispensing of medication from syringe assembly 22 until syringe assembly 22 has advanced to the injection position. Before the syringe reaches the injection position, there are factors that may inhibit medication dispensing. One factor may be friction between piston 32 and syringe body 30. Typically, piston 32 will be made of rubber, and syringe body 30 will be made of glass. The frictional resistance between these two components is sufficient to prevent piston 32 from advancing within syringe body 30 until syringe assembly 22 has advanced to its injection position, and engagement with a suitable stop member prevents syringe assembly 22 from advancing further. Additionally, the medication within the syringe may be somewhat viscous, thus providing some resistance to the outflow needle 34. If necessary, modifying piston 32 and syringe body 30 to change the frictional resistance of the dispensing movement of engagement member 32 relative to syringe body 30 can limit or prevent premature dispensing of medication before syringe 22 reaches its injection position.

[0072] The plunger 44 may include a magnet 25 adjacent to the foot 50. For example... Figure 1-3 As shown, magnet 25 is configured to maintain a fixed axial distance from piston 32. Magnet 25 emits a magnetic field, which is sensed by magnetometers 118 and 112, as will be discussed below. Figure 9A , 9B Let's discuss with 11.

[0073] To activate the drive mechanism 24, a person presses the actuation button 52 at the distal end of the device 20. Pressing the button 52 causes one or two elongated tips 54 on the plunger 44 (such as...) Figure 4 (As shown) Disengages from the shuttle assembly 60, thereby allowing the spring 46 to propel the plunger 44 axially. The spring 46 has a helical shape and surrounds the tip 54. The proximal end of the spring 46 biasably engages the flange 56 on the plunger 44.

[0074] Shuttle assembly 60 may include Figure 6 The upper shuttle component 62 shown and Figure 7 The lower shuttle member 64 is shown. Shuttle members 62 and 64 are fixed together in the final assembly. In the final assembly, the upper shuttle member 62 captures the button 52 and the spring 46, thereby limiting the axial movement of these parts in the distal direction. When the device is in Figure 1 and Figure 2 Under the conditions shown, the tip 54 engages the surface on the upper shuttle 62. Pressing down button 52 causes the protrusion on button 52 to engage the bevel 55 on tip 54, biasing tip 54 inward and disengaging it from the upper shuttle member 62. After tip 54 has disengaged, spring 46 applies a biasing force on flange 56 to cause plunger 44 to... Figure 2 Proceed to the position shown Figure 3The position is shown. As the plunger 44 advances, it moves the syringe assembly 22 to the injection position, and then causes the piston 32 to advance to dispense the drug, as discussed above.

[0075] When the dispensing event is completed, the retraction mechanism 26 optionally retracts the syringe assembly 22 from... Figure 3 The injection position shown is moved back to the retracted position. More specifically, the retraction mechanism is adapted to move the drug container from the injection position to the retracted position during the retraction movement. The retracted position can be similar to the storage position because the syringe assembly is pulled back into the housing 38, so that the needle 34 no longer protrudes proximally from the proximal opening 40 and is fully disposed within the housing 38. In some embodiments, the retracted position can be the same as the storage position. However, in other embodiments, the syringe assembly 22 in the retracted position can be located slightly proximal or distal to the syringe assembly in the storage position. In the illustrated embodiment, the retraction mechanism includes a spring 66, Figure 5 The syringe holder 68 and the rotating member 70, which acts as a follower, are shown. In other embodiments, the device 20 may not include the retraction mechanism 26, allowing the syringe assembly to remain in its injection position indefinitely after the medication has been dispensed, until the syringe assembly is manually removed or repositioned by the user.

[0076] The plunger 44 may include an extension bracket 58, which unlocks the rotating member 70 when the plunger 44 approaches the end of its stroke in the proximal direction. The rotating member 70 is rotatably secured to the lower shuttle member 64 by engagement between a latch and a latch recess in the lower shuttle member 64. The extension bracket 58 unlocks the member 70 by depressing the latch. A spring 66 is torsionally preloaded and has one end engaging with the member 70 and an opposite end engaging with the shuttle assembly 60. When the latch is depressed, the spring 66 rotates the member 70. See also... Figure 7 The member 70 may include a groove for receiving a protrusion 78 on the lower shuttle member 64. At one end of the groove, the member 70 defines an axially extending channel. As the member 70 rotates, the protrusion 78 may move within the groove on the member 70 until the protrusion 78 reaches the axially extending channel.

[0077] Component 70 may rotate within housing 38 but may not move axially relative to housing 38. Other embodiments may include a component 70 that is also axially movable. A radial flange on rotating component 70 may engage a crossbar within housing component 38 to limit proximal movement of component 70. Spring 66 may apply an axial force, a torsional force, or both to component 70 to proximal bias component 70, thereby holding component 70 in an axial position where the radial flange of component 70 engages the internal crossbar of housing component 38. Shuttle assembly 60 may include an axially extending channel or rib that engages a corresponding feature on housing component 38, which allows shuttle assembly 60 to move axially within housing 38 but prevents relative rotation of shuttle assembly 60 relative to housing component 38.

[0078] Spring 66 is also axially preloaded and applies a distally pointing biasing force to shuttle assembly 60. As protrusion 78 reaches the axially extending channel, spring 66 moves shuttle assembly 60 distally within housing 38 as protrusion 78 slides axially through the channel. Damping components may be arranged adjacent to rotating member 70 to slow rotation of member 70 and allow the dispensing event to complete before protrusion 78 reaches the axially extending channel. For example, rotating member 70 may include a skirt with multiple axially extending protrusions disposed in a grease ring to provide damping.

[0079] As the shuttle assembly 60 moves distally, it carries the injection cartridge assembly 22 distally and moves it back to its original position. Figure 2 The storage location is shown. Spring 66 biases distally to compress the return mechanism 26, thereby holding the syringe assembly 22 in its retracted position after a dispensing event. Locking mechanisms (such as pawls on the shuttle assembly 60 and grooves on the housing 38 member) may additionally provide a locking engagement to secure the syringe assembly 22 in the retracted position after a dispensing event, with the needle 34 disposed within the housing 38, thereby allowing the user to safely set or otherwise handle the device 20.

[0080] Injector holder 68 Figure 5 As shown in the diagram, the bow-shaped arm 84 of the holder can grip the barrel 30 of the syringe assembly 22. The syringe holder 68 also includes a flange 86. The flange on the syringe barrel 30 is captured between the arm 84 and the flange 86. A portion of the lower side 88 of the flange 86 engages a small flange 90 on the plunger 44, and thus prevents axial movement of the syringe assembly 22 proximally before the plunger 44 advances. When the shuttle 60 retracts, the lower shuttle member 64 engages the arm 84 to carry the syringe assembly 22 distally to its retracted position.

[0081] although Figure 1-7Exemplary actuation mechanism 24 and exemplary retraction mechanism 26 are depicted and described, but other mechanisms may also be used to drive the syringe assembly 22 from the storage position to the injection position, and / or from the injection position to the retracted position. Such actuation and / or retraction mechanisms may (but are not required to) include one or more springs or deformable portions that store energy when held in a pre-triggered state and release the stored energy when triggered to drive the syringe assembly from the storage position to the injection position, and / or from the injection position to the retracted position. Such mechanisms may (but are not required to) include mechanisms that generate prime movers using a chemical reaction or process (e.g., generating a gas from a mixture of two or more reagents, or by igniting a small amount of flammable or explosive material). Such chemical actuation mechanisms may include one or more storage containers for chemical reagents, a trigger that punctures or opens the storage containers, allows the reagents to mix and / or provides a spark or other ignition source to initiate a chemical reaction, and a movable piston or other component that moves in response to the increased gas pressure generated by the resulting chemical reaction. Such a mechanism may (but is not required to) include a mechanism that uses stored electrical energy (e.g., in a battery) to operate an electric motor that drives and / or retracts the syringe assembly, or to trigger other physical or chemical mechanisms. Such a mechanism may (but is not required to) include hydraulic or pneumatic systems (e.g., pipes), gears, cables, pulleys, or other known components for transferring kinetic energy from one component to another. In some embodiments, instead of having a separate mechanism for driving and then retracting the syringe assembly, a single mechanism may be configured to both drive and then retract the syringe assembly.

[0082] Figure 8 The illustration shows an exemplary placement of one or more main PCBs 82 within an end portion 39 according to a first set of embodiments of device 20. One or more main PCBs may be arranged perpendicular to the longitudinal axis 48 and may be stacked on top of each other, and / or may be arranged adjacent to each other in the same plane perpendicular to the longitudinal axis 48. The main PCBs define an opening 83 through which the injection needle 34 of the syringe assembly 22 is configured, for example, to pass when the end cap 36 is removed and the injection needle is driven proximally to inject the patient during a dispensing event. As shown, the radial distance 45 extending of the main PCBs away from the longitudinal axis 48 is greater than the radial distance 41 of the user-gripable portion 37. Figure 8 One or more sub-PCBs 84, extending substantially perpendicular to the main PCB and parallel to the longitudinal axis 48, are also shown. These sub-PCBs can be communicatively coupled to the main PCB via one or more PCB connectors 114. While additional sensing systems can be mounted on the sub-PCBs 84, such sub-PCBs are optional and can be excluded in some embodiments to reduce manufacturing complexity and cost.

[0083] The end portion 39 can be a favorable location and size for placing the main PCB within the device 20. The increased footprint of the end portion 39 is due to the radial extension of the end portion outward from the longitudinal axis 48 by a radial distance 43, which is greater than the radial distance 41 of the user-gripable portion. Due to the increased footprint, more space is available to accommodate the main PCB and its various components compared to other locations within the device 20. For this purpose, many components can be pre-assembled onto the main PCB located in the favorable position of the end portion 39. As a result, incorporating the main PCB into the end portion 39 requires little or no alteration to the shape of the existing autoinjector housing, reducing disruption to the manufacturing process and lowering manufacturing costs. Furthermore, placing the main PCB in the end portion 39 allows the skin contact sensors 122, 123, and 124 to be positioned further away from the longitudinal axis 48, increasing the reliability of skin contact readings received from these sensors.

[0084] Figure 9A A top perspective view of the main PCB and sub-PCB according to a first embodiment of device 20 is shown, while Figure 9B A bottom perspective view of the same PCB is shown. Figure 10A and 10B Top and bottom views of the same PCB are shown respectively. Main PCB 82 (in Figure 8 (As shown in the diagram) may have a top surface 82a that includes or supports the power supply 102. Figure 9A and 10A As shown in the diagram—top surface 82a is understood to be part of PCB 82—in some embodiments, power supply 102 may include a battery such as a coin cell battery. Power supply 102 provides electrical power to electrical components integrated or coupled to the injection device 20. The main PCB 82 may also include processing circuitry 108. In some embodiments, processing circuitry 108 may take the form of a system-on-a-chip (SOC) integrated circuit including a processor, memory, and input / output ports. However, processing circuitry 108 may also be implemented using other types of components, such as a microcontroller (MCU) or application-specific integrated circuit (ASIC). Processing circuitry 108 may be configured to execute computer-executable instructions stored on a non-transitory storage medium. The main PCB may also include multiple different types of sensors, such as a microswitch sensor 110, a magnetometer 112, an accelerometer 140, an ambient light sensor 106, and / or one or more skin contact resistance sensors 122, 123, and 124. In embodiments that include a sub-PCB, the sub-PCB may include additional sensors, such as another microswitch sensor 116, a magnetometer 118, and an infrared temperature sensor 120.

[0085] Microswitch sensors 110 and 116 can be communicatively coupled to processing circuitry 108. Each microswitch sensor may include a physical switch coupled to circuitry that outputs an electrical signal to processing circuitry 108 depending on the physical position or orientation of the physical switch. Microswitch sensors 110 and 116 can be used to detect the position of components of injection device 20. For example, microswitch sensor 110 can be used to detect whether end cap 36 is attached to the proximal end of device housing 38. As discussed in more detail below, depending on the output of microswitch sensor 110, processing circuitry 108 can indicate to the user whether end cap 36 is attached to device 20. Similarly, microswitch sensor 116 can be used to detect whether syringe assembly 22 is in one of two states, such as (i) storage position or (ii) injection position. Microswitch sensor 116 can also be configured to detect whether syringe assembly 22 is in one of three states, such as (i) storage position, (ii) injection position, or (iii) retracted position. Depending on the output of the microswitch sensor 116, the processing circuit 108 can indicate to the user the position of the syringe assembly 22.

[0086] Ambient light sensor 106 is communicatively coupled to processing circuitry 108 and can detect the amount or intensity of ambient light to which the injection device 20 is exposed. Excessive exposure to ambient light may render the medication stored in cartridge 30 ineffective or unsafe for injection. In some embodiments, processing circuitry 108 can record the intensity and / or duration of ambient light detected by ambient light sensor 106. If the intensity and / or duration of exposure to ambient light exceeds a predetermined threshold, the user can be notified that the medication should not be administered.

[0087] Accelerometer 140 is communicatively coupled to processing circuitry 108 and can determine the orientation of injection device 20 (e.g., pointing up, down, or sideways). This can be important for certain types of pharmaceuticals that may be significantly affected by gravity due to particle settling, etc., requiring delivery with a specific orientation. Processing circuitry 108 can also use the output of accelerometer 140 to alert the user device 20 if injection is incorrectly oriented (e.g., if the device is upside down). As described further below, accelerometer 140 can also be used to detect vibrations from external devices to aid in wireless pairing of injection device 20 with external devices.

[0088] Many types of medications need to be stored at a first relatively cold temperature (e.g., between 36 and 46 degrees Fahrenheit, or between 2 and 8 degrees Celsius) to prevent deterioration, but then need to be heated to a second, warmer temperature (e.g., to room temperature, or between 65 and 75 degrees Fahrenheit, or between 18 and 24 degrees Celsius) before being injected into a patient. To ensure that the medication within the cartridge 30 is stored at the appropriate storage temperature, and / or to ensure that the medication is heated to the appropriate injection temperature, the injection device 20 may be equipped with a mechanism for estimating the medication temperature. By ensuring that the medication has been heated to the appropriate temperature, this information may be transmitted to a telephone, or the device itself may signal to the patient that the device is ready for use. In some embodiments, this temperature measurement function may be performed by an infrared (IR) temperature sensor 120 on the sub-PCB 84. The IR sensor 120 may be communicatively coupled to the processing circuitry 108. Figure 8 Ideally, the IR sensor 120 can be positioned adjacent to and facing the injection cartridge 30. The IR sensor 120 detects and measures electromagnetic radiation in the IR spectrum from the cartridge 30 and outputs an electrical signal based on the detected IR radiation. By sampling the electrical signal output by the IR sensor 120, the processing circuit 108 can estimate the temperature of the drug inside the cartridge 30.

[0089] The main PCB can also be equipped with one or more antennas for transmitting or receiving wireless communications. For example, Figure 9A and 9B A Bluetooth Low Energy (BLE) antenna 104 is depicted on the upper surface 82a of the main PCB, and a Near Field Communication (NFC) antenna 126 (shown as a thick black line element) is depicted on the bottom surface 82b of the main PCB. Other embodiments are also possible, where the main PCB is equipped with only one antenna or only one type of antenna. As discussed in further detail below, these antennas allow the injection device 20 to establish a wireless communication link with an external device.

[0090] The main PCB can also be communicatively coupled or integrated with multiple sensors that detect contact with skin tissue. Skin contact sensors can be used to verify proper contact with the user's skin before the user activates the injection device 20. The injection device 20 can also indicate to the user which sensors detected skin contact and which did not; this lets the user know in which direction he or she should tilt or move the injection device 20 before injection. This feature reduces the likelihood of a failed injection, in which case the needle 34 fails to penetrate the user's skin or penetrates at an inappropriate shallow angle.

[0091] Figure 9B and 10BAn exemplary embodiment comprising three skin contact sensors 122, 123, and 124 is depicted, which are disposed on the bottom surface 82b of a main PCB and arranged in a symmetrical trilobal shape. In this exemplary embodiment, each skin contact sensor 122, 123, and 124 includes two independent electrical terminals—sensor 122 includes terminals 122a and 122b, sensor 123 includes terminals 123a and 123b, and sensor 124 includes terminals 124a and 124b. Although only two electrical terminals are depicted for each sensor, other embodiments with more than two electrical terminals per sensor are also possible. Each skin contact sensor can measure the resistance between its electrical terminals and output an electrical signal to processing circuitry 108 based on the measured resistance. The resistance of skin tissue is generally lower than that of air, and therefore, when the measured resistance is below a predetermined threshold, processing circuitry 108 can determine that a particular skin contact sensor is in contact with skin tissue.

[0092] although Figure 9B and 10B Each skin contact sensor 122, 123, and 124 is depicted as having two electrical terminals, but other embodiments with only one electrical terminal per skin contact sensor are also possible. In such a case, the electrical terminal of one skin contact sensor (e.g., sensor 122) can be used as a reference electrode for outputting a predetermined voltage. The electrical terminals on each of the other two skin contact sensors (e.g., sensors 123 and 124) can be used as sensor electrodes for measuring the resistance of the conductive path between themselves and the reference electrode. When the measured resistance between the reference electrode and the particular sensor electrode is below a predetermined threshold, the processing circuit 108 can determine that both the reference electrode and the particular sensor electrode are in contact with human tissue (such as skin). When both sensor electrodes (e.g., on sensors 123 and 124) report that the measured resistance is below a predetermined threshold, the processing circuit 108 can determine that both the reference electrode and both sensor electrodes are in contact with human tissue. The following is in conjunction with... Figure 17A , 17B Exemplary embodiments of the device 20 including the capacitive sensor will be discussed using a second set of embodiments, 18A and 18B, and device 20.

[0093] like Figure 10B As best shown, each skin contact sensor 122, 123, and 124 can be located from the longitudinal axis 48 (in Figure 10BIn the view shown, extending outwards at radial distances 128, 130, and 132 (extending into the page). Sensors 122, 123, and 124 may optionally be arranged symmetrically around opening 83 such that radial distances 128, 130, and 132 are equal to each other, and the angular spacing between each sensor is also equal (e.g., 120° in this case). Radial distances 128, 130, and 132 are greater than the radial distance 41 of the user-gripable portion 37 (e.g., extending into the page). Figure 2 (as shown in Figure 9), and the length can be greater than 10 mm. For example, in some embodiments, the lengths of the radial distances 128, 130, and 132 can each be between 10 mm and 20 mm—in some cases, a distance of 15 mm to 20 mm may be appropriate. Although three skin sensors are depicted, other embodiments with only one or two skin sensors are also possible. Conversely, embodiments with more than three skin contact sensors are also possible—in such embodiments, the skin sensors can (but are not required) be arranged symmetrically around the opening 83. For example, other embodiments including four to twenty skin sensors are also conceivable.

[0094] Although skin contact sensors 122, 123, and 124 have been described above as measuring resistance, these skin contact sensors can alternatively be configured to detect skin contact by measuring capacitance. Capacitive sensors can be configured to detect the proximity of such tissue by detecting the effect of the electric field generated by the human tissue on the sensor (e.g., by detecting the effect of such tissue on the capacitance of the circuit monitored or measured by the sensor). Capacitive sensors do not require metal electrical terminals in direct contact with the skin tissue and can therefore be partially or completely sealed behind a protective, non-conductive cover (e.g., made of plastic). This increases the durability of the capacitive sensor by reducing the penetration of moisture or foreign matter into sensitive electrical components. Capacitive sensors also reduce the risk of electrostatic discharge damage to sensitive electrical components within the device because they do not require exposed metal contacts. Exemplary embodiments of the device 20 incorporating capacitive sensors are described below regarding... Figure 21A , 21B The third set of embodiments, including 22A and 22B, and device 20, will be discussed.

[0095] The injection device 20 may also be equipped with a device for estimating the axial position or movement of the piston 32 within the barrel 30. This estimated axial position and / or movement may be used by the processing circuitry 108 to estimate the amount of drug remaining and / or the amount of drug already dispensed within the barrel 30, if any. In some embodiments, this may be achieved by providing a magnet on or near the piston 32 as the piston 32 slides along the longitudinal axis 48, and by one or more magnetometers that sense the magnetic field emitted by the magnet as the piston 32 slides along the longitudinal axis. Figure 1-3Figures 1 and 11 show an exemplary magnet 25 disposed on the plunger 44 such that the magnet 25 maintains a fixed axial distance from the piston 32 as the piston slides within the cylinder 30 along the longitudinal axis 48. Figure 9A , 9B Figures 10A and 10B also show an exemplary arrangement of two magnetometers: magnetometer 112 on the main PCB 82 and magnetometer 118 on the secondary PCB 84. As shown, magnetometer 112 can be positioned radially further away from the longitudinal axis 48 than magnetometer 118. Furthermore, magnetometer 118 can be positioned at the midpoint along the length of the cylinder 30, rather than being positioned near one end of the cylinder 30.

[0096] Figure 11 A side view of the injection device 20 is provided, and the spatial relationship between the magnet 25 and the magnetometers 112 and 118 according to a first embodiment of the device 20 is shown. Figure 11 The image depicts an injection device 20, with the syringe assembly 22 in a storage position and an end cap 36 fixed to the device housing 38 to cover the proximal opening 40. When the magnet 25 is sufficiently close to the magnetometer, the magnet 25 outputs a magnetic field that can be sensed by magnetometers 112 and 118. Each magnetometer can output a signal to processing circuitry 108 based on the strength of the sensed magnetic field. As the magnet 25 slides along the longitudinal axis 48 in the direction of arrow 1102, the strength of the magnetic field sensed by magnetometers 112 and 118 varies based on the position of the magnet 25. For example, when the syringe assembly 22 is in the storage position and the piston 32 is in its initial piston position at the distal end of the syringe 30 (e.g., ...). Figure 11 as well as Figure 1 and 2 As depicted, magnetometers 118 and 112 may detect only a very weak or non-existent magnetic field. When the syringe assembly 22 advances to the injection position but the piston 32 remains in its initial piston position, magnetometer 112 may continue to detect only a weak magnetic field or no magnetic field at all, but magnetometer 118 may detect a stronger magnetic field than when the syringe assembly is in the storage position. In some embodiments, by sampling the magnetic field strength measured by magnetometers 112 and 118, processing circuitry 108 can determine whether the syringe assembly 22 is in the storage or injection position.

[0097] When the syringe assembly 22 is in the injection position, and when the piston 32 moves from its initial position toward its final piston position in the direction of arrow 1102 (e.g.) Figure 3As the magnet 25 moves forward (as shown), it approaches, passes by, and then moves away from the magnetometer 118, which detects a rising and then falling magnetic field. Simultaneously, advancing the piston 32 in the direction of arrow 1102 causes the magnetometer 112 to detect a rising magnetic field as the magnet 25 moves closer to it. By sampling the magnetic field strengths detected by magnetometers 118 and 112, the processing circuit 108 can estimate the position of the magnet 25 along the longitudinal axis 48. Based on this position estimate, the processing circuit 108 can estimate the position of the piston 32 and the amount of drug still retained within the cylinder 30.

[0098] Figure 12 A system architecture view of the electrical components within device 20 according to a first set of embodiments of device 20 and the communication link with an exemplary external device 1250 is provided. As described above, processing circuitry 108 may be powered by battery 102 and may include processing core 1208 and memory 1210 (e.g., internal flash memory, onboard electrically erasable programmable read-only memory (EPROM), etc.). Memory 1210 may store instructions that, when executed by processing core 1208, cause processing circuitry 1208 to perform the operations described herein. Processing circuitry 108 may also be communicatively coupled to multiple sensors, such as ambient light sensor 106, end cap microswitch 110, magnetometer 112, accelerometer 140, and skin contact sensors 122, 123, and 124. Processing circuitry 108 may also optionally be communicatively coupled to one or more sub-PCBs via flexible connector 114. Sub-PCBs may also incorporate microswitch 116, magnetometer 118, and IR temperature sensor 120. The processing circuitry 108 may also be connected to a device integrated with device 20 for user feedback 1208. The device for user feedback may include one or more indicator lights (e.g., implemented using light-emitting diodes (LEDs), a display, a tactile indicator such as a vibration motor, and / or an auditory indicator such as a speaker. The processing circuitry 108 may be communicatively coupled to each of the foregoing components via one or more physical and electrical channels such as (but not limited to) general purpose input / output (GPIO) pins, an internal integrated circuit (I2C) bus, a serial peripheral interface (SPI) connection, a universal asynchronous receiver / transmitter (UART) connection, and / or a controller area network (CAN) bus. In some cases, signals received by the processing circuitry 108 from some or all of the sensors may also be converted from analog signals to digital signals using an analog-to-digital converter (ADC).

[0099] The processing circuitry 108 can also be configured to allow the injection device 20 to communicate wirelessly with external devices (such as, for example, mobile phones, wearable devices, laptops, and / or server databases). To facilitate wireless communication, the processing circuitry 108 may include an NFC antenna 1205 (such as...) Figure 9B and 10B The NFC antenna 126 depicted is communicatively coupled to a Near Field Communication (NFC) circuit 1204. The NFC circuit 1204 and NFC antenna 1205 allow the processing circuit 108 to establish a wireless NFC communication link 1232 with an external device 1250. Alternatively or additionally, the processing circuit 108 may include a Bluetooth Low Energy (BLE) circuit 1206 communicatively coupled to a BLE antenna 1207, such as... Figure 9A and 10A The BLE antenna 104 is depicted in the diagram. The BLE circuit 1206 and BLE antenna 1207 allow the processing circuit 108 to establish a wireless BLE communication link 1234 with the external device 1250.

[0100] Figure 12 An exemplary external device 1250 physically separate from the injection device 20 is also shown. In this embodiment, the exemplary external device 1250 may take the form of a mobile smartphone having a processor 1252 (e.g., a microprocessor or CPU) and a storage device 1258. The storage device 1258 may include a non-transitory computer-readable medium storing computer-executable instructions that, when executed by the processor 1252, cause the device 1250 to perform the operations described herein. These computer-executable instructions may include mobile applications, such as medical mobile applications. The device 1250 may further include a display 1260 and a user input device 1262. The user input device 1262 may include physical buttons or switches integrated with the smartphone. Although in Figure 12 The display 1260 is depicted separately, but all or part of the user input device 1262 may be integrated with the display 1260, for example, in a touch-sensitive screen. The device 1250 may also include a vibration source 1264, such as a vibration motor.

[0101] Device 1250 may be configured to establish a wireless communication link with injection device 20. For example, external device 1250 may include NFC circuitry 1254 coupled to NFC antenna 1255, which communicates with processing circuitry 108 via communication link 1232. Device 1250 may also include BLE circuitry 1256 coupled to BLE antenna 1207, which communicates with processing circuitry 108 via communication link 1234.

[0102] Figure 13This is a flowchart illustrating an exemplary process 1300 for “pairing” or establishing a communication session between the injection device 20 and the external device 1250. Process 1300 can be used by any of the first set of embodiments of device 20 as well as any of the second and third sets of embodiments of device 20 described below. To conserve power, the injection device 20 may initially be stored in a low-power sleep mode 1326. When in this sleep mode 1326, some or all components coupled to or integrated with the processing circuitry 108 may be turned off or placed in a low-power state to conserve power. For example, some or all sensors coupled to the processing circuitry 108 may be de-energized, the BLE circuitry 1206 and the BLE antenna 1207 may be de-energized, and some or all of the processing core 1208 may be de-energized or operate at a slower clock speed. If device 20 is in low-power sleep mode 1326, the device may need to be “wake up” before it can pair with the external device 1250.

[0103] One way to wake up the injection device 20 is to configure the external device 1250 to emit an NFC field (e.g., an electromagnetic field) using its NFC circuitry 1254 and NFC antenna 1255 (step 1328). When the external device 1250 is placed close to the injection device 20 (e.g., within a few centimeters), the emitted NFC field induces a current flowing within the NFC antenna 1205 coupled to the processing circuitry 108. The processing circuitry 108 can then be configured to wake the injection device 20 from its low-power sleep mode when it detects this induced current. The processing circuitry 108 can also be configured to wake the device 20 only when it detects an induced current that matches a desired code or pattern, in order to prevent false background electromagnetic radiation from waking up the injection device 20.

[0104] Another way to wake up the injection device 20 is to configure it to wake up when it detects a specific vibration pattern (also step 1328). For example, to wake up the device 20, a user can position the device 20 so that it contacts the external device 1250—for example, the device 20 can be placed on top of the external device 1250. The user can then instruct the external device 1250 to vibrate using the vibration source 1264 according to a specific predetermined pattern. The vibration from the external device 1250 can be detected by the accelerometer 120 in the injection device 20. When the detected vibration matches the expected pattern, the processing circuitry 108 can be configured to wake up the injection device 20 from its low-power sleep mode.

[0105] When the injection device 20 first awakens from its low-power sleep mode, the processing circuitry 108 can initiate a BLE pairing process 1330 with the external device 1250. The BLE pairing process 1330 may be similar to or identical to the BLE pairing process defined in the Bluetooth Core Specification v5.0, published by the Bluetooth SIG on December 6, 2016, the entire contents of which are incorporated herein by reference. The BLE pairing process 1330 may begin by the injection device 20 broadcasting one or more BLE advertising packets using its BLE circuitry 1206 and BLE antenna 1207. When the external device 1250 receives the broadcast BLE advertising packet via the BLE circuitry 1256 and BLE antenna 1257, it can respond with a wireless BLE transmission that initiates a communication process between the injection device 20 and the external device 1250. The end result of this communication process is the establishment of a BLE communication session between the injection device 20 and the external device 1250, through which the two devices can exchange data.

[0106] Figure 14A and 14B This is a flowchart illustrating an exemplary process 1400 implemented by a mobile healthcare application running on an external device 1250. Process 1400 can be used in combination with any of the first set of embodiments of device 20, as well as any of the second and third sets of embodiments of device 20 described below. Process 1400 begins (step 1402) when a BLE connection is established between the injection device 20 and the external device 1250. In step 1404, the external device 1250 receives data from the injection device 20 via the established BLE connection. The data received from the injection device 20 may include data or measurements from some or all of the aforementioned sensors in the injection device 20, or information derived from or based on such data or measurements. The data received from the injection device 20 may also include data stored in the memory of the device 20, or information derived from such data—this data may include the type of medication stored in the injection device 20, the expiration date of the medication, the identity of the prescribing physician, the location or date of manufacture of the medication, the model of the injection device, etc.

[0107] In step 1406, process 1400 determines whether the medication has expired. This can be done by comparing the medication expiration date received in step 1404 with the current date. If the medication has expired, process 1400 branches to step 1414, where an external device 1250 notifies the user that the medication has expired, such as via a message on the device 1250's display or via an auditory message. If the medication has not expired, process 1400 branches to step 1408.

[0108] In step 1408, process 1400 determines whether the drug has been exposed to unsafe conditions. This step may include checking data stored in or derived from an ambient light exposure log stored by processing circuitry 108. If the intensity and / or duration of exposure to ambient light exceeds a predetermined threshold, process 1400 may branch to step 1414 and notify the user that the drug should not be used. The logic for comparing data from the ambient light exposure log with predetermined limits on exposure intensity and / or duration may be performed by processing circuitry 108 of injection device 20, processor 1252 of external device 1250, or a combination of both. Alternatively or additionally, step 1408 may include determining whether the drug has been exposed to unsafe temperatures during storage or transport. This can be achieved by checking data stored in or derived from a drug temperature log stored by processing circuitry 108. If the drug has been exposed to temperatures outside its ideal storage range (e.g., between 36 and 46 degrees Fahrenheit), or if the drug has been exposed to temperatures outside its ideal storage range for an unacceptable duration, process 1400 may also branch to step 1414 and notify the user that the drug should not be used. The logic for comparing temperature log data with predetermined temperature limits may also be executed by the processing circuitry 108 of the injection device 20, the processor 1252 of the external device 1250, or a combination of both.

[0109] In step 1410, process 1400 determines whether the medication is at a safe temperature for injection. While the medication in injection device 20 may need to be stored at a lower temperature (e.g., between 36 and 46 degrees Fahrenheit) to prevent deterioration, the medication may need to be heated to a warmer temperature (e.g., close to room temperature, or between 65 and 75 degrees Fahrenheit) before injection. In step 1410, process 1400 determines whether the medication has been heated to the target injection temperature. If not, process 1400 branches to step 1416, where process 1400 informs the user that the medication is still being heated, and then branches back to step 1410. If yes, process 1400 branches to step 1422 (as in step 1416). Figure 14B (As shown). If, in step 1410, process 1400 determines that the user has started injection before the medication has been heated to the target injection temperature, then process 1400 may branch to step 1414, where process 1414 notifies the user of his / her error and advises the user to allow the medication to be heated to the target injection temperature before dispensing. Alternatively or additionally, process 1400 may also record the user's error in memory and / or send a notification of the user's error to caregivers and / or device manufacturers, payers, or designers.

[0110] Now for reference Figure 14BIn step 1422, process 1400 may instruct the user to remove end cap 36. In step 1424, process 1400 determines whether end cap 36 has been removed. As discussed above, processing circuitry 108 may use end cap microswitch sensor 110 to determine whether end cap 36 has been removed and may notify external device 1205 via BLE communication link 1234. If the end cap has not been removed, process 1400 branches back to step 1422. If the end cap has been removed, process 1400 branches to step 1426.

[0111] In step 1426, process 1400 may instruct the user to position the injection device 20 for injection. This may include instructing the user to place the device 20 flush against a part of the user's body, such as the user's abdomen or one of the user's thighs. In step 1428, process 1400 determines whether all skin contact sensors (e.g., sensors 122, 123, and 124) have detected contact with skin tissue. If not all skin contact sensors have detected contact with skin tissue, process 1400 branches to step 1430. If all skin contact sensors have detected contact with skin tissue, process 1400 branches to step 1432.

[0112] In step 1430, process 1400 may indicate to the user which individual sensors among the plurality of skin contact sensors (e.g., sensors 122, 123, and 124) detected contact with skin tissue and which individual sensors did not detect contact with skin tissue. Figure 15 As shown, this can be accomplished by displaying schematic 1502 on the display 1260 of the external device 1250. Schematic 1502 may include three separate indicators 1522, 1523, and 1524, corresponding to skin contact sensors 122, 123, and 124, respectively. As shown, indicators 1522, 1523, and 1524 may be arranged to mimic the physical arrangement of skin contact sensors 122, 123, and 124; for example, the indicators may be symmetrically arranged around a central opening. In embodiments with fewer or more than three skin contact sensors, schematic 1502 may also include a corresponding number of indicators. When the skin contact sensor does not detect contact with skin tissue, schematic 1502 may change the appearance of the corresponding indicator for the skin sensor. Figure 15In the example shown, skin contact sensors 122 and 123 detect skin contact, but skin contact sensor 124 does not detect contact with skin tissue. Therefore, the indicator 1524 corresponding to skin contact sensor 124 is filled with a different color, texture, or visual pattern than that of indicators 1522 and 1523 corresponding to skin contact sensors 122 and 123 (as shown by the crosshairs of indicator 1524). Other ways of indicating the presence or absence of skin contact are also possible—for example, the shape of the indicator may change, or icons or symbols may appear or disappear, depending on whether a particular skin contact sensor detects any contact with skin tissue.

[0113] Alternatively or additionally, device 20 may be equipped with a visual indicator (e.g., a light-emitting diode (LED)) that indicates to the user which skin contact sensors detected skin contact and which did not. For example, device 20 may have multiple LEDs disposed on the top surface of the main PCB 82a, with each LED corresponding to one of the skin contact sensors. The physical arrangement of the LEDs may correspond to the arrangement of the skin contact sensors to make it clear to the user which LED corresponds to which skin contact sensor—for example, each LED may be disposed on top of its corresponding skin contact sensor. One such exemplary LED has been depicted as... Figure 11 LED 142. Depending on whether the sensor detects contact with skin tissue, the corresponding LED can light up, turn off, and / or change color. This provides the user with another intuitive way to quickly determine which skin contact sensors are not detecting contact with skin tissue, and in what way the user should tilt or move the device 20 to achieve better skin contact.

[0114] Figure 17A A top perspective view of the main PCB 1782 according to a second embodiment of device 20 is shown, while Figure 17B A bottom perspective view of the same PCB 1782 is shown. Figure 18A and 18B Top and bottom views of the same PCB are shown respectively. Similar to the main PCB 82 in the first set of embodiments described above, the main PCB 1782 can also be positioned in the end portion 39 of the housing 38 of the device 20, such as... Figure 8As shown. Similarly to the aforementioned main PCB 82, main PCB 1782 defines an opening 1703 (similar to opening 83 in PCB 82) through which the injection needle 34 of the syringe assembly 22 is configured. Main PCB 1782 includes a top surface 1782a and a bottom surface 1782b (both surfaces 1782a and 1782b are understood as part of PCB 1782). Top surface 1782a includes or supports a power source 1702, which in some embodiments may include a battery, such as a coin cell battery. Power source 1702 provides electrical power to electrical components integrated or coupled to the injection device 20. Main PCB 1782 may also include processing circuitry 1708, which may be configured similarly to the previously described processing circuitry 108.

[0115] The main PCB 1782 in the second set of embodiments may differ from the main PCB 82 in the first set of embodiments in several aspects. For example, from Figure 9A and 17A As best seen in the comparison, instead of the secondary PCB 84, the main PCB 1782 is equipped with a syringe position detector switch 1710, which allows the processing circuit 1708 to determine whether the syringe assembly 22 is in the storage position, injection position, or retracted position. The syringe position detector switch 1710 includes two arms 1710a and 1710b extending proximally. In one example, arm 1710a is an angled arm 1710a, and arm 1710b is positioned adjacent to arm 1710a. In one example, each of arms 1710a and 1710b includes a distal end coupled to PCB 1782 (in the illustrative example, the distal end includes a foot configuration for mounting to the PCB), and the arms may extend proximally in a parallel relationship. An angled arm 1710a includes an angled radial portion and a lateral extension. The radial portion extends inward toward the longitudinal axis 48 for contact with the movable syringe barrel to cause deflection of arm 1710a. The lateral extension overlaps with a contact portion of arm 1710b for selective electrical contact with arm 1710b. Both arms can be made of metal or any other relatively flexible conductive material and can be electrically connected to processing circuitry 1708. When the contact portion of arm 1710a contacts arm 1710b, the contact completes the circuit between the angled arms 1710a and 1710b. When the angled arm 1710a is not in contact with the straight arm 1710b, the circuit between the two arms is broken. By continuously or periodically monitoring whether the two arms 1710a and 1710b are in contact, processing circuitry 1708 can determine whether the syringe assembly is in a storage position, an injection position, or a retracted position.

[0116] Figure 19A side view of the device 20 is shown when the syringe assembly 22 is in the storage position or the retracted position. As shown, when the syringe assembly 22 is in one or both of these positions, the angled arms 1710a and the straight arm 1710b are positioned slightly apart and do not contact each other. Figure 20 A side view of the device 20 is shown when the syringe assembly 22 is in the injection position. As the syringe assembly 22 moves into the injection position, the barrel 30 of the syringe assembly 22 translates downward in the distal direction, as indicated by arrow 1902. Because the barrel 30 has a wider diameter than the needle 34 or needle hub 35, the downward translation of the barrel 30 causes the barrel 30 to contact the angled portion of the angled arm 1710a and push the angled arm 1710a radially away from the longitudinal axis 48, causing it to contact the straight arm 1710b. This completes the circuit between the angled arm 1710a and the straight arm 1710b. Therefore, when the processing circuit 1708 detects an open circuit between arms 1710a and 1710b, it can determine whether the syringe assembly 22 is in the storage position or the retracted position. When the processing circuit 1708 detects a closed circuit between arms 1710a and 1710b, it can determine that the syringe assembly is in the injection position.

[0117] The main PCB 1782 may also differ from the main PCB 82 in the construction of its skin contact sensor. For example, in... Figure 9B and 17BIn the best-of-the-line comparison seen, instead of using three skin contact sensors, each including two electrodes (e.g., in the first set of embodiments, sensor 122 includes electrodes 122a and 122b, sensor 123 includes electrodes 123a and 123b, and sensor 124 includes electrodes 124a and 124b), in the second set of embodiments, the bottom surface 1782b of the main PCB 1782 includes only three single electrodes 1722, 1723, and 1724 pointing distally from the distal surface of the PCB. These electrodes can be radially equidistant from the longitudinal axis 48 and can also be circumferentially equidistant from each other. One of these three electrodes (e.g., electrode 1722) can be connected to a voltage supply providing a reference voltage V. The other two electrodes can each be connected to a separate voltage sensor. The outputs of the two voltage sensors can be connected to processing circuitry 1708. If the voltage sensor connected to electrode 1723 senses a positive voltage above a reference threshold, processing circuitry 1708 can determine that electrodes 1722 and 1723 are both in contact with skin tissue. If the voltage sensor connected to electrode 1724 senses a positive voltage above a threshold, processing circuit 1708 can determine that both electrodes 1722 and 1724 are in contact with skin tissue. If the voltage sensors connected to both electrodes 1722 and 1723 detect a voltage above a threshold, processing circuit 1708 can determine that all three electrodes 1722, 1723, and 1724 are in contact with skin tissue. Compared to the main PCB 82 in the first set of embodiments, this arrangement of electrodes 1722, 1723, and 1724 reduces the number of electrodes required, thereby reducing manufacturing and assembly complexity and cost.

[0118] Although the foregoing description of the second set of embodiments of device 20 describes the differences between the second set of embodiments and the foregoing first set of embodiments, it should be understood that the second set of embodiments may also include features present in the first set of embodiments, as well as other features. For example, some embodiments of the second set of embodiments may include the sub-PCB 84 of the first set of embodiments, in place of or attached to the proximal arms 1710a, 1710b. The sub-PCB 84 in the second set of embodiments may include one, some, or all of the previously described sensors mounted on the sub-PCB 84 in the first set of embodiments. The second set of embodiments of device 20 may also use different configurations of skin contact sensors, including configurations that are the same as or similar to those described with respect to the first set of embodiments. As an example, in some embodiments, the main PCB 1782 in the second set of embodiments may include electrode pairs similar to the electrode pairs described in the first set of embodiments (e.g., electrodes 122a and 122b, 123a and 123b, etc., such as...). Figure 9B (As shown). The main PCB 1782 may include one, two, three or more such electrode pairs.

[0119] Figure 21A A top perspective view of the main PCB 2082 according to the third embodiment is shown, while Figure 21B A bottom perspective view of the same PCB 2082 is shown. Figure 22A and 22B Top and bottom views of the same PCB are shown respectively. Similar to the main PCB 82 in the first set of embodiments described above, the main PCB 2082 can also be positioned in the end portion 39, such as... Figure 8 As shown. Similarly to the main PCB 82 in the first set of embodiments described above, the main PCB 2082 defines an opening 2003 (similar to opening 83 in PCB 82) through which the injection needle 34 of the syringe assembly 22 is configured. The main PCB 2082 includes a top surface 2082a and a bottom surface 2082b (the top surface 2082a and bottom surface 2082b are understood as part of PCB 2082). The top surface 2082 includes or supports a power source 2002, which in some embodiments may include a battery, such as a coin cell battery. The power source 2002 provides electrical power to electrical components integrated or connected to the injection device 20. A battery door (not shown) in the housing 38 may be hinged or swing-open to allow access to the power source 2002. The main PCB 2082 may also include processing circuitry 2008, which may be configured similarly to the previously described processing circuitry 108.

[0120] The main PCB 2082 may optionally differ from the main PCB 82 (in the first set of embodiments) and the main PCB 1782 (in the second set of embodiments) in several aspects.

[0121] First, the main PCB 2082 may not include the secondary PCB 84 or the syringe position detector switch 1710. Other methods (e.g., using an accelerometer) can be used to detect the position of the syringe assembly 22, making the secondary PCB 84 and / or the syringe position detector switch 1710 unnecessary. Removing the secondary PCB 84 and / or the syringe position detector switch 1710 reduces manufacturing and assembly complexity and / or cost.

[0122] Second, the main PCB 2082 can mount or support a temperature check button 2001. The temperature check button 2001 can extend from a port or cutout (not shown) on the housing 38 of the device 20. As discussed in further detail below, the button 2001 can be a physical button that, when actuated by a user, sends an electrical and / or digital signal to energize the processing circuitry 2008 to check the temperature of the device 20 and indicate to the user whether the device 20 is at the correct temperature for administering the medication.

[0123] Third, instead of using NFC or BLE trace antennas arranged on the top and / or bottom surfaces of the PCB, NFC or BLE connectivity can be provided by one or more chip antennas 2004 mounted on the PCB 2082. These chip antennas 2004 can receive signals from the processing circuitry 2008, which enable the antenna to transmit wireless communication to external devices. Although Figure 21A A single chip antenna 2004 is depicted, but some embodiments in the third set of embodiments may include two or more chip antennas, such as a BLE chip antenna and a separate NFC chip antenna. In some embodiments, the processing circuitry 2008 itself may include an integrated BLE antenna, while the chip antenna 2004 may include an NFC antenna. Some embodiments in the third set of embodiments may also use PCB trace antennas (similar to those discussed above for the first set of embodiments) instead of chip antennas.

[0124] Fourth, the main PCB 2082 may include a base cover removal sensor 2010, which allows the processing circuit 2008 to detect whether the base cover 36 is attached to the housing 38 or has been removed by the user. The base cover removal sensor 2010 may be communicatively or electrically coupled to the processing circuit 2008. Figure 23A and 23BA more detailed perspective view of the base cover removal sensor 2010 is provided. The sensor 2010 includes a base 2302 supporting a first arm 2304 and a second arm 2306. The base 2302 may be coupled to a PCB and may be circumferentially disposed along a proximal surface of the PCB. The arms extend proximally away from the base 2302 and may be parallel to each other. The first arm 2304 is connected to a horizontal bar 2310. In one example, the arm 2304 and the bar 2310 form an L-shape and may be a single unit. The bar 2310 further supports an angled protrusion 2308 and a first contact surface 2309. The surface 2309 may be angled with the bar 2307 and extend distally and / or radially inward. The protrusion 2308 is shown suspended from the bar 2310 and disposed between the arms 2304 and 2306. The protrusion 2308 may include an angled portion extending radially inward toward a longitudinal axis 48. The rod 2310 is shown with a multi-planar structure, wherein a first portion adjacent to arm 2304 runs along a first radial plane, and a second portion adjacent to contact surface 2309 runs along a second radial plane further away from the longitudinal axis 48 than the first radial plane. A second arm 2306 is connected to a second contact surface 2307. Contact surface 2307 may be angled with the body of arm 2306 and, in some angles, extend proximally and / or radially outward. Contact surfaces 2307, 2309 are shaped and configured to be in contact in one configuration (such as when the base cover is removed) and in a separated configuration in another configuration (such as, for example, when the base cover is attached), or vice versa. The first arm 2304, the second arm 2306, and the protrusions mounted on the two arms and the contact surfaces may be formed of metal or any other suitable flexible and conductive material.

[0125] Figure 24A The diagram illustrates the relationship between the PCB 2082, the base cover, and the sensor 2010 when the end cap 36 is removed from the rest of the device 20. For clarity, the housing 38 surrounding and supporting the PCB 2082 has been removed. When the sensor 2010 is mounted on the PCB 2082, the angled protrusion 2308 points inward toward the longitudinal axis 48. The end cap 36 includes an internal protrusion 2402. The end cap 36 can be attached to the housing 38 by moving the end cap 36 in the direction of arrow 2404. Figure 24B The diagram shows PCB 2082 and end cap 36 when the end cap 36 is attached. When the end cap 36 is attached, the internal protrusion 2402 extends upward through the opening 2003 in PCB 2082 and abuts against the angled protrusion 2308. This radially pushes the angled protrusion 2308 and the horizontal bar 2310 on which the angled protrusion 2308 is mounted in the direction of arrow 2406.

[0126] Figure 25A and25B It shows when from Figure 23A and 23B When observing the sensor in the direction of axis 2312, remove the base cover from the sensor 2010. Figure 25A The diagram illustrates the removal of the sensor 2010 from its base cover when the sensor is in a neutral state, for example, when the end cover 36 is removed and therefore the internal protrusion 2402 is not in contact with any part of the sensor 2010. When the sensor 2010 is in this neutral state, the first contact surface 2309 is biased by the horizontal bar 2310 into contact with the second contact surface 2307. The contact between the first contact surface 2309 and the second contact surface 2307 completes the circuitry between the first arm 2304 and the second arm 2306. When the processing circuitry 2008 detects that this circuitry has been formed, the processing circuitry 2008 can determine that the end cover 36 has been removed.

[0127] Figure 25B The image illustrates the base cover removal sensor 2010 when the end cap 36 is attached. When the end cap 36 is attached, the internal protrusion 2402 contacts and pushes against the angled protrusion 2308 of the sensor 2010. This push causes the angled protrusion 2308 and the horizontal bar 2310 on which it is mounted to be displaced outward in the direction of arrow 2406. This forces the first contact surface 2309 to move relative to the stationary second contact surface 2307, disengaging from contact with the second contact surface 2307, thereby breaking the circuit between the first arm 2304 and the second arm 2306. When the processing circuit 2008 detects that this circuit has been broken, the processing circuit 2008 can determine that the end cap 36 has been attached.

[0128] Fifth, instead of using electrodes that detect skin contact by measuring resistance (as in the first and second sets of embodiments), the main PCB 2082 uses two capacitive pads 2022 and 2023 to detect skin contact. Pads 2022 and 2023 are shown as discrete planar structures disposed along the distal surface of the PCB. The capacitive pads 2022 and 2023 can be configured to detect the proximity of human tissue by the effect of the electric field generated by such human tissue on the sensor, for example, by measuring the effect of such human tissue on the capacitance of a circuit monitored or measured by the sensor. The capacitive sensor does not require metal terminals in direct contact with the skin tissue and can therefore be partially or completely sealed behind a protective non-conductive cover (e.g., made of plastic). This increases the durability of the capacitive sensor by reducing the penetration of moisture or foreign matter into sensitive electrical components. The capacitive sensor also reduces the risk of electrostatic discharge damage to sensitive electronic components within the device because it does not require exposed metal contacts. The capacitive pads 2022 and 2023 can each detect contact with skin tissue individually, allowing the processing circuitry 2008 to determine when one pad detects contact while the other does not. although Figure 21B and 22B 2022 and 2023 are depicted with only two capacitor pads, but other embodiments in the third set of examples may have fewer or more capacitor pads. For example, the main PCB 2082 may include only a single capacitor pad, or it may have three, four, five, six or more capacitor pads.

[0129] Sixth, in this third embodiment, the main PCB 2082 includes an accelerometer 2012 that detects an impact or acceleration caused by the initiation of a dispensing event, in which the syringe assembly 22 is driven from a storage position to an injection position by a drive mechanism 24. The accelerometer 2012 can also detect an impact or acceleration caused by a retraction motion upon completion of the dispensing event, in which the syringe assembly 22 is driven from an injection position to a retracted position by a retraction mechanism 26. The accelerometer 2012 can send an output signal to the processing circuitry 2008 via one or more electrical connections, allowing the processing circuitry to analyze the output signal.

[0130] Figure 26 A graph illustrating an exemplary signal output from accelerometer 2012 according to a third embodiment is depicted. The vertical Y-axis of graph 2600 shows the signal amplitude in volts. The x-axis of graph 2600 depicts the passage of time, for example, in seconds. In this example, the signal from accelerometer 2012 is centered at a voltage of approximately 1.75V. This 1.75V signal can represent a constant downward gravitational acceleration. Deviations near this constant value indicate the acceleration or impact (other than gravity) experienced by device 20 or device 20, and are detected by accelerometer 2012 mounted on main PCB 2082. For example, accelerometer 2012 can detect acceleration, vibration, or impact caused by removing base cover 36 (indicated by mark 2062) or unlocking actuation button 52 (indicated by mark 2064).

[0131] In some embodiments, processing circuitry 2008 may analyze signals output from accelerometer 2012 to determine a condition or state of device 20, or to detect the occurrence of an event or action. For example, processing circuitry 2008 may analyze output signals to determine when base cover 36 has been removed (e.g., as indicated by the signal at 2062), or when actuation button 52 has been unlocked (e.g., as indicated by tag 2064). Processing circuitry 2008 may also be configured to determine when an assignment event is initiated or completed based on signals from accelerometer 2012, individually or in combination with signals from one or more skin contact sensors.

[0132] When a dispensing event is initiated, drive mechanism 24 is activated to drive syringe assembly 22 from the storage position to the injection position. This drive motion imparts one or more accelerations, which can be detected from the signal output by accelerometer 2012. For example, when drive mechanism 24 drives syringe assembly 22 away from the storage position in the proximal direction, the thrust imparted by drive mechanism 24 can cause accelerometer 2012 to detect acceleration in the distal direction along longitudinal axis 48. When syringe assembly 22 strikes its stop position at the injection position at the end of this drive motion, the sudden stop of syringe assembly 22 can cause accelerometer 2012 to detect acceleration in the proximal direction along longitudinal axis 48. This proximal or distal acceleration (or both) can cause accelerometer 2012 to output a first acceleration spike (indicated by reference numeral 2606) that can be detected by processing circuitry 2008. This first acceleration spike can indicate the initiation of a dispensing event.

[0133] Similarly, when the dispensing event has been completed, the retraction mechanism 26 is activated to drive the syringe assembly 22 from the injection position to the retracted position. This driving motion imparts one or more accelerations, which can also be detected in the signal output from the accelerometer 2012. For example, when the retraction mechanism 26 drives the syringe assembly 22 from the injection position in the distal direction, the thrust imparted by the retraction mechanism 26 can cause the accelerometer 2012 to detect acceleration in the proximal direction along the longitudinal axis 48. When the syringe assembly reaches the retracted position, the sudden stop of the syringe assembly 22 can cause the accelerometer 2012 to detect acceleration in the distal direction along the longitudinal axis 48. This proximal or distal acceleration (or both) can cause the accelerometer 2012 to output a second acceleration spike (indicated by mark 2068) that can be detected by the processing circuitry 2008. This second acceleration spike can indicate the completion of the dispensing event. As used herein, an “acceleration spike” is defined as any artificial phenomenon in the acceleration or vibration signal output by an accelerometer or vibration sensor (e.g., a piezoelectric sensor) that indicates the initiation and / or completion of an assignment event.

[0134] Seventh, instead of using the IR sensor 120 mounted on the sub-PCB 84 to measure the temperature of the drug in the cylinder 30 (e.g. Figure 8 and 9AAs shown, in the third embodiment, the main PCB 2082 utilizes a temperature sensor 2025 directly mounted on the main PCB 2082 to estimate the temperature of the drug. This temperature sensor can be communicatively or electrically coupled to the processing circuitry 2008 and output a temperature output signal received and analyzed by the processing circuitry. In one example, the temperature sensor 2025 is mounted on the distal surface of the PCB and, in some cases, is circumferentially spaced from pads 2022 and 2023. By using the temperature sensor 2025 directly mounted on the main PCB 2082 and completely omitting the sub-PCB 84, the main PCB 2082 in the third embodiment reduces manufacturing and assembly costs and complexity.

[0135] Temperature sensor 2025 may include any of a variety of temperature sensors that can be mounted on a PCB, such as, but not limited to, thermistors (e.g., negative temperature coefficient (NTC) thermistors or resistance temperature detectors (RTDs)), thermocouples, or semiconductor-based temperature sensors. Temperature sensor 2025 may be configured and positioned to measure the temperature of a thermal ballast. The thermal ballast may include all or a portion of the silicon substrate of the main PCB 2082 itself. Alternatively, the thermal ballast may include a suitable heat sink made of other materials (e.g., polymers) mounted on the main PCB 2082. The thermal ballast may be in contact with or surround all or a portion of temperature sensor 2025.

[0136] The material, size, shape, and location of the thermal ballast can be selected to give it a thermal time constant (τ) close to that of the drug in the cylinder. 药品 The thermal time constant (τ) 镇流器 As used herein and in the claims, the “thermal time constant (τ)” of an object (such as a thermal ballast or a drug within cylinder 30) should be understood as a constant that satisfies the following Equation 1:

[0137] Equation 1:

[0138] in:

[0139] T(t) = the temperature of the object at time t;

[0140] T ∞ = The ambient temperature of the medium surrounding the object (e.g., the atmosphere); and

[0141] T i = Initial temperature of the object

[0142] In other words, the thermal time constant τ of an object characterizes the rate at which the object's temperature adjusts to match the ambient temperature of its environment—a high thermal time constant means the object adjusts its temperature quickly, while a low thermal time constant means the object adjusts its temperature slowly. Therefore, when the thermal ballast has a thermal time constant (τ) close to that of the drug in the cylinder 30... 药品 The thermal time constant (τ) 镇流器 In this case, it can be assumed that the temperature of the thermal ballast rises or falls at approximately the same rate as the drug temperature to match the ambient temperature. Because the thermal ballast can be mounted on the main PCB 2082, it will typically be exposed to the same ambient temperature as the drug in the canister 30. Therefore, the processing circuit 2008 can estimate the temperature of the drug in the canister 30 by measuring the temperature of the thermal ballast and assuming that the temperature of the drug in the canister 30 is equal to the measured temperature. Thus, in this third embodiment, the main PCB 2082 can estimate the temperature of the drug in the canister 30 without having to place an infrared (IR) sensor or other type of temperature sensor exactly next to (or in physical contact with) the canister 30. This reduces manufacturing and assembly costs and complexity, and also reduces the space and form factor requirements of the device 20.

[0143] In some embodiments, the material, size, shape, and / or location of the thermal ballast can be selected such that τ 镇流器 In τ 药品 Within 10%. In other embodiments, the material, size, shape, and / or location of the thermal ballast can be selected such that τ 镇流器 In τ 药品 Within 5%. In some embodiments requiring high-precision determination of drug temperature, the material, size, shape, and / or location of the thermal ballast can be selected such that τ 镇流器 In τ 药品 Within 2%. In another embodiment, the material, size, shape, and / or location of the thermal ballast can be selected such that when both the ballast and the drug are brought from a first relatively cold storage temperature (e.g., between 36 and 46 degrees Fahrenheit, or between 2 and 8 degrees Celsius) to a second relatively warmer temperature (e.g., to room temperature, or between 65 and 75 degrees Fahrenheit), the temperature of the ballast is always within a certain degree (e.g., + / - 2°C, or + / - 5°C) of the drug in the cylinder 30.

[0144] Figure 27 A system architecture view of the electrical components within device 20 according to a third set of embodiments of device 20 is provided. Some or all of these components can be installed as previously described... Figure 21A , 21BOn the main PCB 2082 depicted in 22A and 22B. As previously described and depicted in the foregoing figures, these electrical components may include processing circuitry 2008. In some embodiments, processing circuitry 2008 may take the form of a Bluetooth Low Energy (BLE) System-on-Chip (SOC). Such a BLE SOC may include a chip comprising computing circuitry (e.g., a microprocessor or arithmetic logic unit (ALU)), onboard memory (e.g., a non-transitory computer-readable medium, such as volatile or non-volatile memory) for storing programming instructions executed by the computing circuitry, and a BLE antenna 2714. Processing circuitry 2008 is configured to control and coordinate... Figure 27 The function of the electrical components described.

[0145] According to the third set of embodiments, the processing circuit 2008 can be powered in one of two ways: it can receive power from the battery 2002 via the battery enabling circuit 2718, or it can receive power from the battery 2002 via the power latching circuit 2716. The battery enabling circuit 2718 can be one or more physical circuits that route power from the battery 2002 to the processing circuit 2008 when certain conditions are met, and cut off power to the processing circuit 2008 when those conditions are not met. In other words, the battery enabling circuit 2718 can both power on and power off the processing circuit 2008 depending on the sensed conditions. For example, in some embodiments, the battery enabling circuit 2718 may route power to the processing circuit 2008 when either of the following two conditions is met: i) the base cover removal sensor 2010 detects that the base cover 36 has been removed, and / or (ii) the temperature check button 2001 mounted on the main PCB 2082 has been pressed and is being held down by the user, or the temperature check button 2001 has been pressed within a past period of time (e.g., within the past 45 minutes). The battery enabling circuit 2718 may also route power to the processing circuit 2008 when both conditions are met. In some embodiments, the battery enabling circuit 2718 may consider only condition (i) or (ii), without considering the other of condition (ii) or (i). The battery enabling circuit 2718 may also be configured to consider other conditions besides or alternative to those discussed above, such as device orientation, sensed shock or acceleration, or temperature. If neither of the two conditions is met, the battery enabling circuit 2718 can be configured to cut off the power to the processing circuit 2008.

[0146] The power latch circuit 2716 may be one or more physical circuits that receive output signals from the processing circuit 2008 via general purpose input / output (GPIO) pins. The power latch circuit 2716 may be configured to route power from the battery 2002 to the processing circuit 2008 when it receives a "power latch" signal from the processing circuit 2008 via a GPIO pin. This power latch signal may be a simple high or low voltage signal, or it may be a more complex coded signal including multiple high and / or low voltage signals. Once the power latch circuit 2716 receives the power latch signal, it will "latch," meaning it will continue to route power from the battery 2002 to the processing circuit 2008 regardless of whether the power latch circuit 2716 continues to receive power latch signals. In other words, once the power latch circuit 2716 is latched, it will continue to supply power to the processing circuit 2008 until the battery 2002 is depleted (or a timer indicating the expected battery life of the battery 2002 expires, thus indicating that the battery 2002 is nearing depletion). Depending on the embodiment, the processing circuit 2008 may be configured to send a power latch signal to the power latch circuit 2716 under different circumstances.

[0147] Although the battery enabling circuit 2718 and the power latching circuit 2716 may take the form of one or more physical circuits performing the functions described above, they may also take the form of software or firmware instructions stored on a non-transitory computer-readable medium (e.g., non-volatile memory) that perform the functions described above when executed by the processing circuitry. For example, a secondary low-power processor may be mounted on the main PCB 2082, which is separate and independent from the processing circuitry 2008 and determines when power is supplied from the battery 2002 to the processing circuitry 2008.

[0148] The processing circuitry 2008 can also be connected to the internal integrated circuit (I2C) bus 2724. The I2C bus can then be communicatively coupled to multiple electrical components, including NFC circuitry 2004, one or more touch sensors 2706, accelerometer 2012, and battery gauge 2710.

[0149] NFC circuit 2004 may include an NFC antenna and onboard non-volatile memory, and may support both passive and active NFC communication. Passive NFC communication occurs when NFC circuit 2004 communicates with an external device while NFC circuit 2004 is not powered, wherein NFC circuit 2004 relies solely on power provided wirelessly by the external device. Active NFC communication occurs when NFC circuit 2004 communicates with an external device while NFC circuit 2004 is powered by an internal power source (e.g., battery 2002). In embodiments where NFC circuit 2004 supports active NFC communication, NFC circuit 2004 may be coupled to battery 2002. NFC circuit 2004 may also be configured to passively (i.e., not powered by battery 2002) store data and / or programming instructions received via its NFC antenna to its onboard non-volatile memory.

[0150] The touch sensor 2706 can take the form of capacitive pads 2022 and 2023, as previously described. Figure 21B and 22B As described and illustrated in [the original text]. However, the touch sensor 2706 can also take the form of any other type of sensor configured to detect contact with skin tissue, including those previously described in [the original text]. Figure 9B The resistance sensors 122, 123, and 124 depicted and described in [the text], and / or previously [described in the text] Figure 17B The resistive sensors 1722, 1723, and 1724 are depicted and described in the text. In other words, the touch sensor 2706 is not limited to the touch sensors described with respect to the third set of embodiments, but may also include some or all of the skin contact sensor features described with respect to the first and second sets of embodiments.

[0151] The accelerometer 2012 can take the form of any circuit configured to detect and distribute the initiation and / or completion of an associated shock, vibration, and / or acceleration, as previously described. For example, the accelerometer 2012 can take the form of an accelerometer configured to detect acceleration along one, two, or three axes, or it can take the form of a piezoelectric vibration sensor.

[0152] The battery gauge 2710 may be physical circuitry, software, and / or firmware that monitors the remaining power stored in the battery 2002 and reports the remaining power level to the processing circuitry 2008.

[0153] The processing circuit 2008 can also be coupled to other electrical components via channels other than the I2C bus 2724. For example, the processing circuit 2008 can be coupled to the aforementioned temperature sensor 2025 via analog input pins. The processing circuit can also be coupled to a watchdog integrated circuit (IC) 2722 via GPIO pins. The watchdog IC 2722 can be an integrated circuit with a continuously running counter. The integrated circuit can be configured to reset or restart the processing circuit 2008 when the counter expires (e.g., by sending a "reset" signal or interrupting power to the processing circuit 2008). The counter can be reset by a check signal from the processing circuit 2008. The processing circuit 2008 can further be configured to periodically send a check signal to the watchdog IC 2722. In this configuration, the watchdog IC 2722 helps ensure that the processing circuit 2008 is not erroneously trapped in a programming loop. By periodically sending a check signal to the watchdog IC 2722, the processing circuit 2008 indicates that it is not trapped in an erroneous programming loop or some other fault condition. If the watchdog IC 2722 does not receive a detection signal from the processing circuit 2008 when the counter expires, the watchdog IC 2722 will send a "reset" signal to the processing circuit 2008 (and / or cut off the power) to force the processing circuit 2008 to restart itself.

[0154] Figure 28 This is a flowchart illustrating an exemplary process 2800 implemented by the processing circuit 2008 when it receives power, according to a third embodiment of device 20. In this exemplary embodiment, if the processing circuit 2008 stops receiving power at any point, all progress through process 2800 is lost. Therefore, when the processing circuit 2008 receives power again, it restarts at the beginning of process 2008, i.e., at step 2802.

[0155] Process 2800 begins at step 2802, where the battery enabling circuit 2718 supplies power to the processing circuit 2008. As previously described, this occurs when: (i) the base cover removal sensor 2010 detects that the base cover 36 has been removed, and / or (ii) when the temperature check button 2001 mounted on the main PCB 2082 has been pressed or held by the user during a specific time period (e.g., the last 45 minutes). After the processing circuit 2008 begins receiving power, it proceeds to step 2804.

[0156] In step 2804, the processing circuitry 2008 reads the Universally Unique Identifier (UUID) and / or the drug type from a memory (e.g., a non-volatile and non-transitory computer-readable medium). This memory may be a non-volatile memory coupled to or integrated with the processing circuitry 2008, and it has been programmed during the manufacture or assembly of the device 20. In some embodiments, the memory may be coupled to or integrated with the NFC circuitry 2004.

[0157] A UUID may include a serial number or a sequence of alphanumeric symbols. Depending on the embodiment, the UUID may be unique for a specific device 20, a specific manufacturing batch of device 20 (e.g., a batch of devices manufactured on a specific assembly line on a specific date), and / or a specific device configuration. The UUID may also specify the type of drug contained within device 20. Alternatively, the memory may store a data field separate from the UUID that specifies the type of drug contained within device 20. In some embodiments, the processing circuitry 2008 may also read other data and / or programming instructions from the memory.

[0158] Some or all of this data (e.g., UUID, drug type, programming instructions, and / or other data) can be stored in a memory coupled to or integrated with the NFC circuit 2004 instead of the processing circuit 2008 to simplify the manufacturing and assembly process. In some embodiments, depending on the configuration of the device 20, the programming memory coupled to or integrated with the processing circuit 2008 may require the processing circuit 2008 to be powered on. Such programming operations can consume valuable power stored in the battery 2002, thereby reducing the available battery life of the entire device. On the other hand, the memory coupled to or integrated with the NFC circuit 2004 can be programmed with some or all of this data via passive NFC communication without drawing any power from the battery 2002. Therefore, to save power, the instructions to be executed by the processing circuit 2008 can be programmed into the NFC circuit 2004 via passive NFC communication during manufacturing. Then, when the processing circuit 2008 is powered on, it can be configured to read the stored data / instructions from the memory of the NFC circuit 2004. After the processing circuit 2008 reads the UUID, drug type and / or any other data or programming instructions from the memory, the processing circuit 2008 proceeds to step 2805.

[0159] In step 2805, the processing circuit 2008 begins to periodically broadcast wireless signals conveying the status of the injection device 20 via the BLE antenna 2714. In some embodiments, these wireless signals may take the form of BLE advertising packets, although other types of wireless signals and wireless protocols may also be used. The wireless signals may be broadcast at regular intervals, such as once per second or once every five seconds, and may contain data about some or all of the following parameters or fields: (i) the device's UUID, (ii) an indication of the type of medication, (iii) an indication of whether the base cap is still attached to the device, whether the base cap has been removed from the device, and / or an indication of whether the base cap has been removed and reattached to the device, (iv) the amount of time elapsed since the base cap was first removed (e.g., in seconds), (v) the duration of skin contact (e.g., the amount of time the device has been in contact with the skin), (vi) an indication of whether a dose has been initiated and / or whether a dose has been initiated and completed, (vii) the detected dose start time, and / or the time elapsed since the initiated dose was completed. (viii) The elapsed time, which in some embodiments may be defined as the amount of time between the initiation and completion of the dose event, (ix) the temperature sensed by the temperature sensor 2025, (x) the device orientation measured by the accelerometer, (xi) the temperature check count, such as the number of times the user has pushed the temperature check button, (xii) the orientation of the device when the dose is given, (xiii) the detected fault or error condition associated with any or all of the temperature sensor, accelerometer, skin contact sensor and / or base cover removal sensor, (xiv) any data derived or calculated from one or more fields from (i) to (xiii), and / or (xv) any other device or environmental conditions observed or measured by that device.

[0160] Throughout process 2800, processing circuitry 2008 may periodically broadcast these wireless signals. During this time, in step 2805, some or all fields included in the wireless signals may be empty or blank until processing circuitry 2008 begins receiving and processing data from the onboard sensors of device 20. As processing circuitry 2008 receives and processes signals from the onboard sensors of device 20 (e.g., base cover removal sensor 2010, touch sensor 2706, accelerometer 2012, temperature sensor 2025, etc.), it continuously updates the transmitted wireless signals to reflect the latest status of the device. Processing circuitry 2008 then proceeds to step 2806.

[0161] In step 2806, processing circuit 2008 determines whether a drug stored in device 20 requires temperature checking based on UUID, drug type, and / or other data and programming instructions. Some types of drugs that can be administered through device 20 may require temperature checking, while others may not. If the stored drug does not require temperature checking, processing circuit 2008 branches to step 2810. If the drug does require temperature checking, processing circuit 2008 branches to step 2808.

[0162] In step 2808, the processing circuit 2008 checks the temperature measured by the temperature sensor 2025. As previously mentioned, this temperature can indicate the temperature of the drug stored in the cylinder 30. The sensed temperature is then included in a continuous stream of wireless signals that are periodically broadcast.

[0163] In step 2812, the processing circuit compares the measured temperature with a preset threshold to determine whether the measured temperature meets certain predefined and pre-stored ideal injection temperature parameters. For example, when the measured temperature is within the ideal temperature range for injection, such as between 65 and 75 degrees Fahrenheit, or between 18 and 24 degrees Celsius, the measured temperature meets the ideal injection temperature parameters. In other, simpler embodiments, the processing circuit may simply determine whether the measured temperature is above a certain minimum temperature threshold (e.g., above 65 degrees Fahrenheit or 18 degrees Celsius), without determining whether the measured temperature is below a certain maximum temperature threshold. If the measured temperature meets the ideal injection temperature parameters, the processing circuit 2008 branches to step 2814, where the processing circuit 2008 sets an indicator to notify the user of the determination. Such an indicator may include one or more LEDs, a halo, a message on a display, or a panel that slides open to display a message or color on the body of the injection device. After setting such an indicator, the processing circuit 2008 branches to step 2810. If the measured temperature does not meet the ideal injection temperature parameters, the processing circuit 2008 branches directly to step 2810 without setting the indicator.

[0164] In step 2810, processing circuit 2008 checks whether touch sensor 2706 has detected contact with skin tissue. If touch sensor 2706 has detected contact, processing circuit 2008 branches to step 2816. If touch sensor 2706 has not detected contact, processing circuit 2008 continues to loop back to step 2810 until skin contact is detected. Again, processing circuit 2008 automatically updates the wireless signal based on the output of touch sensor 2706.

[0165] In step 2816, processing circuitry 2008 reads the output of accelerometer 2012. In some embodiments of process 2800, processing circuitry 2008 does not read or evaluate the output of accelerometer 2012 unless skin contact is detected. This can be achieved by cutting off power to accelerometer 2012 unless skin contact is detected, so that accelerometer 2012 does not output any acceleration signal unless skin contact is detected. Alternatively, accelerometer 2012 may receive power and output acceleration signals even when no skin contact is detected, and processing circuitry 2008 may be configured to record the skin contact time and duration in memory, but otherwise not take action based on any output signal from accelerometer 2012 until skin contact is detected. By requiring skin contact to be detected before determining that an assignment event has been detected, processing circuitry 2008 mitigates the occurrence of false positives, in which processing circuitry 2008 records an assignment event even if no assignment event has occurred.

[0166] In step 2818, the processing circuit 2008 determines, based on the output of the accelerometer 2012, whether the allocation event has been initiated and completed. This determination can be performed in different ways, and exemplary logic for performing this determination is described below. Figure 29 , 30 Further details are provided in steps 31 and 32. If no completed allocation event is detected, processing circuit 2008 branches back to step 2810. If processing circuit 2008 determines at step 2818 that both the allocation event has been initiated and completed, processing circuit 2008 records the initiation and / or completion of the allocation event in memory. Processing circuit 2008 may also communicate the initiation and / or completion of the allocation event to the user by setting indicators, such as one or more LEDs, light rings, or other visual and / or auditory indicators. Thereafter, processing circuit 2008 branches to step 2820.

[0167] In step 2820, the processing circuit sends a signal to the power latch circuit 2716, causing the power latch circuit 2716 to latch. As previously described, once the power latch circuit 2716 is latched, it will continue to route power from the battery 2002 to the processing circuit 2008 until the battery 2002 is depleted. After the power latch circuit 2716 is latched, the processing circuit 2008 proceeds to step 2822.

[0168] In step 2822, processing circuit 2008 starts a time-from-dose counter. This time-from-dose counter can be an internal or external counter of processing circuit 2008 that counts continuously at regular periodic intervals (e.g., every second, every 30 seconds, or every minute). In some embodiments, the time-from-dose counter only starts counting when processing circuit 2008 reaches step 2822 (or when power latch circuit 2716 is latched in step 2820). In other embodiments, the time-from-dose counter can start counting from the moment processing circuit 2008 receives power (e.g., at battery enable event 2802), and when processing circuit 2008 reaches step 2822, processing circuit 2008 records the current value of the time-from-dose counter.

[0169] In step 2824, processing circuit 2008 updates the broadcast wireless signal to indicate that the allocation event has been successfully initiated and completed. As previously discussed, the wireless signal may include the detected dose start time and / or the amount of time elapsed since the initiated dose was completed. In an embodiment where a time counter starting to count from the dose start timer when processing circuit 2008 reaches step 2822, the broadcast signal may include the current value of the time counter starting from the dose start timer. In an embodiment where the time counter starting from the dose start timer continuously counts upwards from the moment processing circuit 2008 receives power, the broadcast signal may include the difference between the current value of the time counter starting from the dose start timer and the value of the time counter starting from the dose start timer when processing circuit reaches step 2822.

[0170] The periodically broadcast wireless signals can be received by an external device, such as mobile device 1250. These wireless signals enable the external device to determine the type or configuration of device 20, the type of medication administered to the patient, the temperature of the medication at the time of administration (or whether the medication temperature at the time of administration meets the ideal injection temperature parameters), and / or the amount of time that has elapsed since the medication was administered. The external device can also determine the absolute time of medication administration at its location by subtracting the amount of time that has elapsed since the medication was administered from the current absolute time (e.g., the time determined by a clock integrated into or communicating with the external device). For example, if the external device receives a wireless signal from device 20 indicating that medication was administered one hour ago, and if the clock on the external device indicates that the current time is 2:00 PM Eastern Standard Time on December 21, 2018, the external device can determine that the medication was administered at 1:00 PM Eastern Standard Time on December 21, 2018 by subtracting the elapsed time (1 hour) from the current absolute time.

[0171] After each broadcast, processing circuit 2008 monitors the remaining power level in battery 2002 via battery gauge 2710 (step 2826). Processing circuit 2008 then compares the remaining power level with a minimum low battery threshold (step 2828). If the remaining battery power level is greater than the low battery threshold, processing circuit 2008 branches back to step 2824, where it continues broadcasting the wireless signal. If the remaining battery power level is less than or equal to the low battery threshold, processing circuit 2008 determines that it will soon lack the power to continue effectively broadcasting the wireless signal. As a result, processing circuit 2008 branches to step 2830.

[0172] In step 2830, processing circuit 2008 writes its "final state" to NFC circuit 2004. This "final state" may include information indicating both (i) that the dispensing event was initiated and completed, and (ii) the current value (e.g., X hours, minutes, or seconds) of the time counter since the dose was administered when processing circuitry reaches step 2830. Since NFC circuit 2004 can be queried even when it is not powered by battery 2002, writing this "final state" to NFC circuit 2004 ensures that external devices will still be able to determine at least these two pieces of information by querying NFC circuit 2004. In other words, external devices will still be able to determine that device 20 (i) successfully dispensed its drug load, and (ii) the drug was dispensed at least X hours, minutes, or seconds prior.

[0173] Process 2800 can be modified by rearranging, deleting, adding, or reconfiguring certain steps. For example, in some embodiments, process 2800 can be configured to avoid broadcasting wireless signals until a successful allocation event has been detected, i.e., before reaching step 2824. By avoiding broadcasting wireless signals before an allocation event is detected, process 2800 can conserve battery power and also minimize signal interference or clutter in environments where other devices are also transmitting and receiving wireless signals. In some embodiments, process 2800 may not continuously check battery level 2826, but instead can use a timer to determine when to write the “final state” to NFC circuitry 2004 and turn it off. This timer can be configured such that instruction processing circuitry 2008 writes the “final state” and turns off after a specific period of time has elapsed since processing circuitry 2008 was first powered on or when processing circuitry 2008 first began transmitting wireless signals.

[0174] Figure 29An exemplary circuit diagram is depicted illustrating the logic used to determine whether an allocation event has been initiated and completed (i.e., step 2818 in process 2800). Although the logic is depicted and described as a circuit diagram, it should be understood that the logic can be implemented as hardware logic circuitry, software or firmware instructions executed on processing circuitry, or some combination of hardware, software, and / or firmware.

[0175] like Figure 29 As shown, the output signal from accelerometer 2012 first passes through a high-pass filter, which includes a capacitor 2904 and a resistor 2906 connected to ground 2908. The high-pass filter is configured to filter out low-frequency acceleration signals due to gravity, but allow high-frequency signals from sharp impacts / accelerations indicating the initiation or completion of a distribution event to pass through. The output of the high-pass filter is fed into the first input of signal comparator 2912. The second input of signal comparator 2912 is connected to a reference voltage threshold 2910. When the output of the low-pass filter is greater than or equal to the reference voltage threshold 2910, signal comparator 2912 outputs an ON signal (e.g., high voltage); otherwise, signal comparator 2912 outputs an OFF signal (e.g., low voltage). In other words, if an acceleration spike is detected, i.e., if the high-pass filtered signal from accelerometer 2012 is greater than or equal to the reference voltage threshold 2910, the output of signal comparator 2912 is turned on. Otherwise, signal comparator 2912 outputs an OFF signal.

[0176] The output of signal comparator 2912 is coupled to the first input of AND gate 2916. The second input of AND gate 2916 is coupled to a valid touch signal 2914. The valid touch signal 2914 can be turned on or off based on the output of touch sensor 2706—an ON signal can indicate that a valid skin contact has been detected, while an OFF signal can indicate that a valid skin contact has not been detected. Some embodiments of device 20 with multiple skin contact sensors may require all skin contact sensors to detect a valid skin contact before the valid touch signal 2914 is turned on. Alternatively, some embodiments of device 20 may require only one or a specified number or subset of the multiple skin contact sensors to detect a valid skin contact before the valid touch signal 2914 is turned on. Therefore, the output of AND gate 2916 is turned on only when both of the following conditions are met: (i) an acceleration spike is detected (i.e., the output of signal comparator 2912 is turned on) and (ii) a valid touch signal 2914 is detected. The simultaneous occurrence of conditions (i) and (ii) indicates that a dispensing event has been initiated, wherein the syringe assembly 22 is driven from the storage position to the injection position by the drive mechanism 24. By requiring conditions (i) and (ii) to be satisfied before determining that a dispensing event has been initiated, this logic mitigates the possibility of false positives, in which case a dispensing event is recorded when no actual dispensing event has occurred.

[0177] The output of AND gate 2916 is coupled to the first input of OR gate 2918, which functions as a trigger event latch. The second input of OR gate 2918 is coupled to its output. The output of OR gate 2918 remains closed until the output of AND gate 2916 outputs an ON signal. Afterward, OR gate 2918 will remain open indefinitely until it is reset (e.g., by cutting off power to OR gate 2918). If the output of AND gate 2916 is closed again after being open, the output of OR gate 2918 will remain open. OR gate 2918 is therefore called a trigger event latch because it "latches" after a trigger event (e.g., the initiation of an assignment event) and remains open indefinitely.

[0178] The output of OR gate 2918 is coupled to debouncing circuit 2932. Debouncing circuit 2932 outputs an OFF signal until the following two conditions are met: (i) the trigger event latch outputs an ON signal indicating that the initiation of an allocation event has been detected, and (ii) the output of AND gate 2916 outputs an OFF signal. In other words, debouncing circuit 2932 only turns on after detecting a first acceleration spike indicating the initiation of an allocation event, and only after the first acceleration spike has passed and is no longer detectable. Once both conditions are met, the debouncing circuit will remain on indefinitely until it is reset.

[0179] The debouncing circuit 2932 includes an inverter 2920, an AND gate 2922, and an OR gate 2924. The output of the AND gate 2916 is inverted by the inverter 2920 before being passed to the first input of the AND gate 2922. The output of the trigger event latch (OR gate 2918) is passed to the second input of the AND gate 2922. Therefore, the output of the AND gate 2922 will only be on when (i) the trigger event latch output is on and (ii) the output of the AND gate 2916 is off. The output of the AND gate 2922 is coupled to the first input of the OR gate 2924. The second input of the OR gate 2924 is coupled to the output of the OR gate 2924. Therefore, the output of the OR gate 2924 is off until the output of the AND gate 2922 is on. Thereafter, the OR gate 2924 will remain on indefinitely until it is reset, for example by cutting off power to the OR gate 2924. If the output of AND gate 2922 is turned off again after it has been turned on, the output of OR gate 2924 will remain on.

[0180] The output of the debounce circuit 2932 is coupled to the first input of the AND gate 2926. The second input of the AND gate 2926 is coupled to the output of the AND gate 2916. Therefore, the output of the AND gate 2926 will only be turned on when both of the following conditions are met: (i) the debounce circuit 2932 is turned on, indicating that a first acceleration spike indicative of the initiation of the dispensing event has been detected, and the first acceleration spike has now passed; and (ii) the output of the AND gate 2916 is turned on, indicating that a second acceleration spike has been detected, and valid skin contact has been detected simultaneously. This second acceleration spike indicates the completion of the dispensing event, wherein the syringe assembly 22 is driven from the injection position to the retracted position by the retraction mechanism 26 in a retraction movement. Again, by requiring valid skin contact to be detected simultaneously with the detection of the acceleration spike before recording the retraction movement, this logic mitigates the possibility of false positives, where a retraction event is recorded when no retraction event actually occurs.

[0181] The output of AND gate 2926 is coupled to the first input of OR gate 2928, which acts as a retraction event latch. The second input of OR gate 2928 is coupled to its output. Therefore, the output of OR gate 2928 remains closed until the output of AND gate 2926 opens, indicating that a second acceleration spike in the retraction motion indicative of completion of the dispensing event has been detected. Once the output of AND gate 2926 opens, OR gate 2928 is latched, remaining open indefinitely until it is reset by cutting off power to OR gate 2928 (even if the output of AND gate 2926 subsequently closes). OR gate 2928 is thus referred to as a "retraction event latch" because it latches indefinitely after a retraction event is detected, such as the retraction motion of syringe assembly 22 driven from the injection position to the retraction position by retraction mechanism 26. The output of OR gate 2928 is coupled to the dispensing event output signal 2930.

[0182] Therefore, in general, the allocation event output signal 2930 is turned on and remains on only when the following conditions are met: (i) a first acceleration spike is detected simultaneously with effective skin contact, thus indicating that the allocation event has been initiated; (ii) the first acceleration spike has passed; and (iii) a second acceleration spike is detected simultaneously with effective skin contact, thus indicating that the allocation event has been completed and a retraction motion has been detected. When all these conditions (i)-(iii) are met, the allocation event output signal 2930 is latched on, thereby indicating that both the allocation event has been initiated and completed. As stated above... Figure 28 As discussed above, once the processing circuit 2008 determines that both the allocation event has been initiated and completed, the processing circuit 2008 can record the initiation and / or completion of the allocation event in memory, and also communicate the completion of the allocation event to the user.

[0183] Figure 29 An exemplary method for detecting acceleration spikes is described, which involves passing the output signal of an accelerometer through a high-pass filter and then comparing the filtered signal with a reference voltage threshold—an acceleration spike is detected if the filtered signal is greater than the reference threshold. However, it should be understood that other methods for detecting acceleration spikes can also be used, either instead of or supplemented to the above. Figure 29 The method described in the text.

[0184] exist Figure 33Another exemplary process 3300 for detecting acceleration spikes is described and depicted. In step 3302, processing circuitry 2008 records a skin contact sample, denoted as C[n], in a first-in-first-out (FIFO) buffer. Processing circuitry 2008 also records a raw accelerometer sample, denoted as S, output from accelerometer 2012, in another FIFO buffer. raw [n]. In this exemplary process 3300, C[n] and S raw [n] is a discrete digital sampled signal. For example, C[n] may include data indicating whether skin contact was detected each time touch sensor 2706 is sampled. Depending on the embodiment, C[n] may include individual samples for each sampling time of each sensor in the touch sensors, a single sample indicating whether any sensor detected skin contact, a single sample indicating whether all or a subset of the sensors detected skin contact, or other data derived or calculated from the output of one or more of the touch sensors 2706. C[n] may include a binary indication of whether contact was detected, or data indicating the determinism of skin contact. raw [n] can include the output signal from the accelerometer 2012 at each time sample. Depending on the embodiment, C[n] and S raw The sampling rate of [n] can be different. For example, C[n] can be sampled at a rate of 20Hz, while S[n] can be sampled at a rate of 20Hz. raw [n] can be sampled at a rate of 1600Hz. With C[n] and S raw When the [n] FIFO buffer is full, the oldest sample will be deleted to make room for new samples.

[0185] In step 3304, the processing circuit 2008 causes S to... raw [n] Through a filter, such as a high-pass or band-pass filter, and then set S f [n] is equal to the amplitude of the filtered signal, used to calculate the filtered acceleration signal S. f [n]. In some embodiments, the processing circuit 2008 may further process the filtered signal to remove any acceleration detected due to the effects of gravity.

[0186] In step 3306, the processing circuit performs processing on S f [n] is integrated to calculate the integral signal S. int [n]. The integral signal S int [n] can be used to move the window S before, after, or both before and after time n. f The integral signal S is calculated by summing a certain number of samples of [n]. int [n] can also be used arbitrarily according to S fScaling is achieved by varying the scaling factor [n]. Calculate S int An exemplary way of [n] is described in Equation 1 below:

[0187] Equation 1:

[0188] According to Equation 1, if S f [n] is less than a certain minimum acceleration signal threshold S min (For example, 3.5Gs), then S int [n] will be set to 0. However, if S f [n] is greater than S min Then S int [n] will be passed through S first f [n](For example, S) f [n]+S f [n+1]+S f [n+2]...+S f The next W samples of [n+W] are integrated (e.g., summed), and the result of the integration is then multiplied by a scaling factor to derive the product. The parameter W can vary depending on the implementation—for example, W can be set to 150 samples.

[0189] The scaling factor can be used to allow the processing circuitry 2008 to adjust its sensitivity depending on how tightly the user grips the device 20. This can be based on S... f The scaling factor is calculated using the magnitude of [n]. For example, in this embodiment, S is used. max -S f The [n] terms calculate the scaling factor, where S max It is a constant. In some embodiments, S max The scaling factor can be set to be equal to the maximum measurable acceleration signal of the accelerometer 2012 (e.g., 8 Gs). The scaling factor helps the processing circuitry 2008 adapt its sensitivity to the acceleration sensed in different environments. For example, when a user grips the device 20 tightly, the detected acceleration signal may be severely damped—in this case, the scaling factor will be larger. When the device 20 is gripped loosely, the detected acceleration may be less damped—in this case, the scaling factor will be smaller. Other methods for calculating the scaling factor are also possible. Generally, any method for calculating the scaling factor can be used, where S... f Increasing [n] results in a smaller scaling factor (and vice versa).

[0190] In step 3308, the processing circuit 2008 detects or records the acceleration spike at each time n that satisfies the following condition:

[0191] (1)S f[n]≥S min

[0192] (2)D min ≤S int [n]≤D max

[0193] (3) No acceleration spikes were detected in the N number of samples before n.

[0194] The purpose of condition (1) is to ensure that only the filtered acceleration signal S... f An acceleration spike is detected when [n] is greater than a minimum threshold (e.g., 3.5Gs).

[0195] The purpose of condition (2) is to ensure that the integral signal S int [n] at a certain minimum threshold D min (e.g., 2.5) and a certain maximum threshold D max (For example, 8). Values ​​2.5 and 8 are merely exemplary and may vary depending on the implementation. If S int [n] is too small (i.e., less than D). min If the acceleration detected at S[n] is too short and / or too strong to be caused by the initiation and / or completion of the assignment event, then the acceleration is unlikely to correspond to an acceleration spike, as it is too brief and / or too strong to be caused by the initiation and / or completion of the assignment event. int [n] is too large (i.e., greater than D) max If the acceleration detected at S[n] is not likely to correspond to an acceleration spike, the device is subjected to too strong or too sustained acceleration force rather than caused by the initiation and / or completion of the distribution event. Such strong and / or sustained acceleration may be caused, for example, by a user dropping the device 20 onto a hard surface or by the device 20 being pushed during handling or transportation.

[0196] The purpose of condition (3) is to ensure that once an acceleration spike is detected, the processing circuit 2008 stops searching for another acceleration spike for at least N samples. For example, the processing circuit 2008 can be configured to stop searching for acceleration spikes for one second after the first acceleration spike is detected. This mitigates the occurrence of false positives, in which noise or vibration from a single trigger or retraction event causes multiple acceleration spikes to be detected.

[0197] Process 3300 is merely exemplary and can be modified in different ways. For example, step 3304 can be omitted, allowing direct access from S... raw [n] instead of S f [n] Calculate the integral signal S int [n]. Step 3306 can be achieved by calculating S. int[n] can be modified without using a scaling factor, or with a scaling factor different from that in Equation 1. Step 3306 can also be done by calculating S for all n values. int [n] is used to modify, and not just S f [n] is greater than S min Those values. When filtering S in condition 2. int When [n], some embodiments may utilize only the maximum threshold D. max And without using the minimum threshold D min Other embodiments may utilize only the minimum threshold D. min And without using the maximum threshold D max In addition, besides S after time n... f In addition to integrating or summing the value of [n], or replacing the value of S before time n, f The value of [n] can be integrated or summed, or it can be obtained by integrating or summing the values ​​of S before time n. f S is calculated by integrating or summing the values ​​of [n]. int [n].

[0198] Alternatively, process 3300 can be modified so that it only occurs when S... f When the current received value of [n] represents the most recent peak, by adjusting S in step 3306 f S is calculated by [n] integration (and optionally scaling). int [n]. When S f When the currently received sample [n] is the highest received sample within the last N samples (e.g., N can be set to 1,000 accelerometer samples), it represents the most recent peak. This is in addition to or replaces the previously described method for calculating S. int The condition of [n], for example S f [n] is greater than or equal to S min It can be applied only in S f S is calculated only if [n] is the value of the most recent peak. int The requirement of [n]. This requirement is only applied when S is received. f S is calculated when [n] reaches its most recent peak. int [n], Process 3300 can mitigate the occurrence of false positives, in which aftershocks or vibrations from a falling or impacting device are mistaken for acceleration spikes indicating the initiation and / or completion of an allocation event. In other words, S f The sample [n] does not represent the value of the most recent peak and therefore may indicate aftershocks or damped vibrations caused by a drop or impact on the device, making it unsuitable to be considered as a potential acceleration spike indicating the initiation and / or completion of an allocation event. In some embodiments, step 3306 may be further modified such that if a value greater than S is received... min But less than the recent peak Sf The additional samples of [n] can expand the sample size N. This means that if the last few samples are greater than S... min Therefore, process 3300 can consider a larger number of recent samples, instead of strictly considering only the last N samples when calculating the recent peak.

[0199] Other methods for detecting acceleration spikes can also be used. For example, such acceleration spikes can be detected by analyzing the frequency content of the signal output by the accelerometer 2012, for example, by processing the output signal using a Fast Fourier Transform (FFT). If the frequency components of the accelerometer output signal are higher than a specific frequency threshold or exceed a preset threshold within a specific frequency range, the processing circuit 2008 can determine that an acceleration spike has been detected. Another way to detect acceleration spikes is to differentiate the accelerometer output signal. If the differential of the output signal has an amplitude greater than a certain threshold, the processing circuit can determine that an acceleration spike has been detected. Generally, the processing circuit 2008 can use any process or algorithm for detecting acceleration spikes from severe shocks or vibrations experienced by the indicating device 20. Any of these processes or algorithms for detecting acceleration spikes can be used... Figure 30 , 31 The process described and illustrated in 32.

[0200] Figure 30 This is a flowchart illustrating another exemplary process 3000 according to a third set of embodiments, which may be implemented by processing circuitry 2008 to detect the initiation and completion of allocation events (e.g., step 2818 in process 2800). Process 3000 may be similar to Figure 29 The logic shown may differ in some aspects.

[0201] After step 3002 begins, processing circuit 2008 branches to step 3004, where it evaluates whether at least one skin contact sensor (e.g., at least one, a specified number, a specified subset, or all of touch sensors 2706) has detected contact with the skin. If so, processing circuit 2008 branches to step 3006, where it reads or analyzes the acceleration signal output by accelerometer 2012 to detect acceleration spikes. If not, processing circuit 2008 continues looping back to step 3004 until skin contact is detected. Processing circuit 2008 does not read or analyze any signal output by accelerometer 2012 until skin contact is detected, thus mitigating false positives. Again, this can be achieved by cutting off power to accelerometer 2012 so that it does not output any signal (unless skin contact is detected). Alternatively, even when no skin contact is detected, the accelerometer 2012 can receive power and output an acceleration signal to the processing circuit 2008, but the processing circuit 2008 can be configured not to proceed to step 3006 unless skin contact is detected.

[0202] In step 3006, processing circuit 2008 reads or analyzes the acceleration signal output by accelerometer 2012 to detect acceleration spikes. This can be done using any of the procedures or methods described above for detecting acceleration spikes. After analyzing the accelerometer output signal, processing circuit 2008 can branch to step 3008.

[0203] In step 3008, processing circuit 2008 determines whether a first acceleration spike is detected upon skin contact. If not, processing circuit 2008 branches back to step 3004. If yes, processing circuit branches to step 3010, where processing circuit 2008 determines that the first acceleration spike may be caused by the initiation of an allocation event. Therefore, processing circuit 2008 records the initiation of the allocation event by setting an indicator in memory or by setting logic circuitry, and proceeds to step 3012.

[0204] In step 3012, processing circuitry 2008 again evaluates whether at least one skin contact sensor (e.g., at least one, a specified number, a specified subset, or all of touch sensors 2706) has detected contact with the skin. If yes, processing circuitry 2008 branches to step 3014. If not, processing circuitry 2008 continues to loop back to step 3012 until skin contact is detected. Again, processing circuitry 2008 does not read or evaluate any signal output from accelerometer 2012 until skin contact is detected.

[0205] In step 3014, the processing circuit reads or analyzes the acceleration signal output by the accelerometer 2012 again to detect acceleration spikes. This analysis can be performed using any of the methods discussed above.

[0206] In step 3016, processing circuit 2008 determines whether a second acceleration spike is detected upon skin contact. If not, processing circuit 2008 branches back to step 3012. If yes, processing circuit 2008 branches to step 3018, where processing circuit 2008 determines that the second acceleration spike is most likely caused by the retraction motion upon completion of the allocation event. Therefore, processing circuit 2008 records the completion of the allocation event and proceeds to step 3020.

[0207] In step 3020, the processing circuit 2008 records and / or communicates the initiation and completion of the allocation event. As previously described, this can be accomplished by recording the allocation event in memory and / or broadcasting a wireless signal announcing the completion of the allocation event. Alternatively or additionally, the processing circuit 2008 may indicate to the user that the allocation event has been completed by turning one or more LEDs on or off, emitting a sound, or via any other visual, tactile, or auditory indicator.

[0208] Figure 31 This is a flowchart illustrating another exemplary process 3100 according to a third set of embodiments, which may be implemented by processing circuitry 2008 to detect the initiation and completion of allocation events (e.g., step 2818 in process 2800). Process 3100 may be similar to Figure 29 and 30 The logic is shown, but it can differ in some respects. Specifically, process 3100 uses a timer to ensure that a second acceleration spike is detected within a preset time after the first acceleration spike before the allocation event is determined to be complete. If the second acceleration spike is not detected within the preset time, processing circuit 2008 ignores or deletes the first acceleration spike. Process 3100 also reverses... Figure 29 and 30 The operational sequence discussed in the text is: instead of continuously monitoring skin contact from at least one touch sensor 2706 and only reading / evaluating the signal from the accelerometer 2012 when skin contact is detected, process 3100 continuously reads / evaluates the acceleration spikes of the signal from the accelerometer 2012 and only reads / evaluates the signal from at least one touch sensor 2706 when an acceleration spike is detected.

[0209] After starting from step 3102, processing circuit 2008 branches to step 3104, where processing circuit 2008 continuously or periodically reads, monitors, and / or evaluates the signal output from accelerometer 2012, regardless of whether any skin contact is detected. This differs from the above... Figure 30 The logic described herein stipulates that the processing circuitry does not read, monitor, and / or evaluate any signals from the accelerometer 2012 until skin contact is detected. The processing circuitry 2008 may use any of the techniques discussed above to analyze acceleration spikes in the signals from the accelerometer 2012. Once a first acceleration spike is detected, the processing circuitry 2008 proceeds to step 3105. The processing circuitry 2008 may also optionally record the occurrence of the first acceleration spike in memory.

[0210] In step 3105, processing circuit 2008 determines whether at least one skin contact sensor (e.g., at least one, a specified number, a specified subset, or all of touch sensors 2706) detected skin contact when the first acceleration spike was detected. If not, processing circuit 2008 branches to step 3108, where it either ignores the first acceleration spike or deletes the memory record showing the occurrence of the first acceleration spike, and then branches back to step 3104. If yes, processing circuit 2008 branches to step 3106.

[0211] In step 3106, processing circuit 2008 determines that the first acceleration spike is caused by the initiation of a dispensing event, wherein syringe assembly 22 is driven from the storage position to the injection position by drive mechanism 24. Processing circuit 2008 also starts a timer that counts down from a preset duration (e.g., a specified number of seconds). After starting the timer, processing circuit 2008 proceeds to step 3110.

[0212] In step 3110, processing circuit 2008 determines whether the timer has expired. If yes, processing circuit 2008 branches to step 3108. If not, processing circuit 2008 proceeds to step 3112.

[0213] In step 3112, the processing circuit 2008 continuously or periodically reads, monitors, and / or evaluates the second acceleration spike from the signal output of the accelerometer 2012, regardless of whether any skin contact is detected. If no second acceleration spike is detected, the processing circuit 2008 branches back to step 3110, where it evaluates whether a timer has expired. If a second acceleration spike is detected, the processing circuit 2008 branches to step 3114. The processing circuit 2008 may also optionally record the occurrence of the second acceleration spike in memory. The processing circuit 2008 thus continuously loops between steps 3110 and 3112 until the timer expires (in which case, the processing circuit 2008 branches to step 3108) or a second acceleration spike is detected (in which case, the processing circuit 2008 branches to step 3114).

[0214] In step 3114, processing circuit 2008 determines whether at least one skin contact sensor (e.g., at least one, a specified number, a specified subset, or all of touch sensors 2706) detected skin contact when the second acceleration spike was detected. If not, processing circuit 2008 branches to step 3116, in which it either ignores the second acceleration spike or deletes the memory record of the occurrence of the second acceleration spike, and then branches back to step 3110. If yes, processing circuit 2008 branches to step 3118.

[0215] In step 3118, the processing circuit 2008 determines that the second acceleration spike is caused by the retraction motion upon completion of the allocation event. The processing circuit 2008 then stops the timer, records the initiation and completion of the allocation event in memory, and / or communicates the initiation and / or completion of the allocation event to an external device or user.

[0216] Figure 32 This is a flowchart illustrating yet another exemplary process 3200 according to a third set of embodiments, which may be implemented by processing circuitry 2008 to detect the initiation and completion of an allocation event (e.g., step 2818 in process 2800). Process 3200 may be similar to... Figure 29 , 30 The logic is the same as shown in 31, but may differ in some respects. Specifically, process 3200 imposes a requirement that the two acceleration spikes fit within a certain time window before determining that the allocation event has been initiated and completed. Process 3200 also requires that, before determining that the allocation event has been successfully initiated and completed, at least one skin contact sensor detects skin contact during the time period between the first and second acceleration spikes.

[0217] After step 3202 begins, processing circuit 2008 proceeds to step 3204, in which processing circuit 2008 continuously reads, monitors, and / or evaluates acceleration spikes in the signal output from accelerometer 2012. Processing circuit 2008 can analyze the signal from accelerometer 2012 to detect acceleration spikes using any of the techniques discussed above.

[0218] In step 3206, processing circuit 2008 determines whether two acceleration spikes fitted within a specified time window are detected. If yes, the processing circuit branches to step 3212; otherwise, processing circuit 2008 branches back to step 3204. For example, only if the time interval between the detection of two acceleration spikes is not less than a minimum time threshold T. min In the case of (e.g., 1 second), the processing circuit 2008 may branch to step 3212. Alternatively or additionally, the processing circuit may only branch to step 3212 if the two acceleration spikes are detected to be no more than a maximum time threshold T apart. max In cases where the event occurs (e.g., between 5 and 10 seconds), processing circuitry 2008 can branch to step 3212. In some embodiments, the time window may include only the maximum time threshold T. max And excluding the minimum time threshold; in other words, the minimum time threshold T min It can be set to 0 seconds.

[0219] In step 3212, processing circuitry 2008 determines whether at least one skin contact sensor (e.g., at least one, a specified number, a specified subset, or all of touch sensors 2706) detected skin contact during the time period between the first and second acceleration spikes. Some illustrative criteria for evaluating skin contact are listed below:

[0220] (1) Skin contact was detected throughout the entire period between the first and second acceleration spikes.

[0221] (2) Skin contact was detected at a point between the first and second acceleration peaks, but only briefly.

[0222] (3) Skin contact is detected at a point between the first and second acceleration peaks for a specified duration, for example, between 1 and 3 seconds, or between 50 and 100% of the time period between the first and second acceleration peaks.

[0223] (4) Skin contact was detected only at the first acceleration peak, however briefly.

[0224] (5) Skin contact was detected during the specified duration at the first acceleration peak.

[0225] (6) Skin contact was detected only at the second acceleration peak, however briefly.

[0226] (7) Skin contact was detected during the specific duration that led to the second acceleration spike.

[0227] Depending on the embodiment, processing circuit 2008 may evaluate any detected skin contact against any one or more of the criteria (1)-(7) listed above. For example, processing circuit 2008 may maintain a log or buffer in memory of the time and / or duration of the most recently sensed skin contact, and then consult that log in step 3212 to determine whether there is a skin contact that meets the applicable criteria. If processing circuit detects a skin contact that meets the applicable criteria, processing circuit 2008 branches to step 3216. If the applicable criteria are not met, processing circuit 2008 branches to step 3204.

[0228] In step 3216, the processing circuit 2008 determines that the first acceleration spike is caused by the initiation of the allocation event, and the second acceleration spike is caused by the retraction motion upon completion of the allocation event. The processing circuit 2008 then records the initiation and completion of the allocation event in memory, and / or communicates the initiation and / or completion of the allocation event to an external device or user.

[0229] Thus far, process 3000 ( Figure 30 ), 3100 Figure 31 ) and 3200 ( Figure 32 Each of these processes is described as being implemented by processing circuitry 2008 within device 20. However, in some embodiments, some or all of the steps in each of these processes may be performed by processing circuitry at an external device separate from device 20, or in coordination with such processing circuitry, such as processor 1252 at external device 1250 (see [link to relevant documentation]). Figure 12For example, some or all of the steps in each of processes 3000, 3100, and 3200 may be performed by a processor within a mobile device (e.g., a smartphone or laptop) or by a server that receives skin contact data and accelerometer data from device 20. This skin contact and accelerometer data may be derived from measurements or signals output by skin contact sensor 2706 and / or accelerometer 2012 and may be received via a wireless communication link between device 20 and an external device or via a network communication link (e.g., via the Internet or a cellular network). The external device may then record the completion of the assignment event in memory or a report, notify and / or communicate the assignment event to the user, or perform other actions or steps based on the completion of the assignment event. The steps performed by the external device may be performed in real time, for example, while device 20 is measuring data, or at some point after device 20 has measured and recorded the skin contact and accelerometer data (e.g., hours, days, or years).

[0230] Although the foregoing description of the third set of embodiments of device 20 describes the differences between this third set of embodiments and the first and second sets of embodiments described above, it should be understood that the third set of embodiments may also include features present in the first or second set of embodiments, as well as other features. For example, some embodiments of the third set of embodiments may include the sub-PCB 84 of the first set of embodiments, including some or all of the sensors previously described and mounted thereon. Some embodiments of the third set of embodiments may also include the proximal arms 1710a, 1710b of the second set of embodiments.

[0231] Figure 34 An exemplary sequence 3400 of user steps for using the drug injection device 20 is shown. This exemplary sequence 3400 can be applied to any of the first, second, or third sets of embodiments of the device 20 described herein. The device 20 may begin at step 3402, in which the device is maintained in a storage environment (e.g., a refrigerator) at a relatively cold storage temperature (e.g., between 36 and 46 degrees Fahrenheit, or between 2 and 8 degrees Celsius) to protect the drug stored therein from deterioration.

[0232] In step 3404, the user removes device 20 from the storage environment.

[0233] In step 3406, the user may optionally press the temperature check button to wake up the processing circuitry on device 20 and detect its temperature. For devices belonging to the first group of embodiments, this can be accomplished by pressing the button to wake up the processing circuitry 108 and read the IR sensor 120. For devices belonging to the third group of embodiments, this can be accomplished by pressing the temperature check button 2001 and causing the processing circuitry 2008 to read the temperature sensor 2025.

[0234] In step 3408, one or more LEDs mounted on device 20 may light up or flash to indicate the temperature status, thereby informing the user whether the drug stored in device 20 is at or within the ideal temperature range for administration (e.g., at room temperature, or between 65 and 75 degrees Fahrenheit, or between 18 and 24 degrees Celsius). For drugs that do not require temperature checks, steps 3406 and 3408 may be skipped.

[0235] In step 3410, if no further activity is detected, device 20 may return to sleep mode to conserve battery power. Device 20 may enter sleep mode by de-energizing some or all of its electrical components or by operating some of its components in a low-power mode. For example, in some embodiments, device 20 enters sleep mode by cutting off power to its processing circuitry. In some cases, power may be cut off from the processing circuitry when the user releases the temperature check button. In other cases, power may be cut off from the processing circuitry for a preset period of time (e.g., a few seconds or minutes) after the user releases the temperature check button. Other electrical components (e.g., LEDs and / or sensors) may also be de-energized to conserve power.

[0236] In step 3412, device 20 detects when the user removes the base cover 36. For devices belonging to the third group of embodiments, device 20 may use the base cover removal sensor 2010 to detect when the base cover 36 has been removed. This action causes device 20 to wake up again, for example, by energizing its processing circuitry.

[0237] In step 3414, the user presses device 20 against his or her body (e.g., his or her abdomen) and activates the device by unlocking and pressing the actuation button 52 on the distal end of device 20. Unlocking and pressing the actuation button 52 causes the drive mechanism 24 to drive the syringe assembly 22 from the storage position to the injection position. For the device in the third set of embodiments, device 20 senses the contact with the user's skin and the acceleration spikes associated with the movement of the syringe assembly 22. As discussed earlier, these two sensed parameters can be interpreted by device 20 as indicative of the initiation of a dispensing event.

[0238] In step 3416, at the end of the dispensing event, the retraction mechanism 26 drives the syringe assembly 22 from the injection position to the retracted position. For the device in the third embodiment, device 20 senses the contact with the user's skin and the acceleration spike associated with the retraction movement of the syringe assembly 22. As discussed earlier, these two sensed parameters can be interpreted by device 20 as indications of the completion of the dispensing event.

[0239] In step 3418, device 20 illuminates one or more LEDs mounted on the device body to indicate to the user that the allocation event has been successfully initiated and completed.

[0240] In step 3420, device 20 repeatedly broadcasts injection data. This data may be received by an external device (e.g., mobile device 1250) and indicates that the dispensing event has been successfully initiated and completed, the amount of time elapsed since the completion of the dispensing event, the type and / or configuration of device 20, the type of drug administered, or any other data or parameters sensed and / or stored by device 20. An application running on the external device may optionally acknowledge receipt of the data by sending an acknowledgment message to device 20.

[0241] In step 3422, the device 20 may be arranged in any suitable manner, for example, in the depicted container of sharp objects.

[0242] Users of the disclosed injection device may have varying levels of proficiency and / or experience when operating the device. Users with a high level of proficiency and / or experience in operating the device may require fewer instructions and / or supervision when dispensing medication using the disclosed device. Conversely, users with a low level of proficiency and / or experience in operating the device may require additional instructions and / or supervision. However, providing longer and / or more detailed instructions to all users may frustrate or tire users with a high level of proficiency and / or experience. Similarly, providing increased supervision to all users by caregivers, regardless of proficiency and / or experience level, may be unnecessarily costly, as experienced users may not require such supervision. A method is needed to determine the user's proficiency and / or experience in correctly operating the disclosed injection device. This determination should allow the disclosed injection device, mobile devices communicating with such injection device, and / or caregivers to provide supplemental instructions, supervision, and / or training only to users who require such instructions or training. A method is also needed to assess how the user's proficiency and / or experience in operating the disclosed injection device changes over time. Through repeated use, users can be expected to improve their proficiency with the disclosed device. If some users do not improve their proficiency with the disclosed device over time, or do not improve as quickly as other users, caregivers may provide such users with supplemental instructions, supervision, and / or training. Alternatively or additionally, if users do not improve their proficiency over time or exhibit certain common and recurring errors in operating the device, caregivers, manufacturers, designers, distributors, and / or those who pay for the delivery of such devices may redesign the device and / or provide modified or supplemental usage instructions.

[0243] Figure 35-40Various exemplary processes are described to determine whether a user of any of the injection devices disclosed herein possesses a high or low level of proficiency and / or experience in operating the injection device. Some or all of these processes may also be used to detect certain potential misuses of the injection device. Each process may be implemented on one or more processing circuits. One or more processing circuits may be entirely located on the injection device (e.g., processing core 1208 in device 20; see...). Figure 12 ), entirely on an external device that communicates wirelessly with the injection device (e.g., processor 1252 on an external device 1250 that communicates wirelessly with device 20 via communication links 1232 and / or 1234; see Figure 12 Alternatively, the processing circuitry can be distributed between the injection device and the external device. In embodiments where one or more processing circuits are distributed between the injection device and the external device, some steps of each process can be performed on the injection device, while other steps of the process can be performed on the external device. In some embodiments, some or all steps of each process can also be jointly performed by processing circuitry on both the injection device and the external device. Figure 35-40 The processes described can be executed or implemented independently, sequentially, or in parallel.

[0244] Figure 35 This is a flowchart depicting an exemplary process 3500 for generating an indication of whether a user of any injection device disclosed herein possesses a high or low level of proficiency or experience in operating the injection device. Process 3500 measures the amount of time elapsed between when one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates a dispensing event. If the measured time exceeds a threshold duration, one or more processing circuits implementing process 3500 thereon can generate a user indication signal indicating that the user may have a relatively low level of proficiency or experience.

[0245] Process 3500 begins at step 3502, in which a drug delivery device is provided. An example of a suitable drug delivery device is device 20, including any embodiments disclosed herein. The provided drug delivery device may include a device housing defining an internal volume and an opening communicating with the internal volume. The drug delivery device may include a syringe assembly at least partially disposed within the internal volume, the syringe assembly including a barrel configured to hold a drug and an injection needle extending from the barrel, and a drive mechanism configured to move the syringe assembly from a storage position to an injection position, in which the injection needle at least partially extends out of the opening. In some embodiments, as described herein, the drug delivery device may also optionally include a retraction mechanism configured to move the syringe assembly from the injection position to a retracted position.

[0246] The drug delivery device may also include one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor being configured to detect contact with skin tissue. Suitable skin contact sensors include both resistive and capacitive sensors, as discussed herein.

[0247] The drug delivery device may also include one or more syringe assembly sensors disposed within the device housing, configured to output syringe assembly sensor signals based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly. In some embodiments, the syringe assembly sensor may include one or more sensors configured to determine the position of a piston sliding along the longitudinal axis of the syringe assembly, such as magnetometers 112 and / or 118, configured to detect or measure the magnetic field generated by magnet 25 (see [link to relevant documentation]). Figure 11 In other embodiments, the syringe assembly sensor may include one or more sensors configured to detect the position of the syringe assembly. Suitable examples of such a syringe assembly sensor include a microswitch sensor 116 (see...). Figure 9A ) and / or syringe position detector switch 1710 (see Figure 17A , 17B 19, 20). In other embodiments, the syringe assembly sensor may include one or more sensors configured to detect acceleration caused by the syringe assembly as it moves from a storage position to an injection position or from an injection position to a retracted position. A suitable example of such a syringe assembly sensor includes an accelerometer 2012 (see 19, 20). Figure 21A ).

[0248] In step 3504, the processing circuitry determines when one or more skin contact sensors detect contact with skin tissue. As discussed in detail herein, skin contact sensors can detect contact with skin tissue in different ways, such as by measuring resistance between two or more terminals and / or measuring capacitance. In some embodiments, step 3504 may include recording in memory a timestamp corresponding to the time point when the one or more skin contact sensors detect contact with skin tissue. Alternatively or additionally, step 3504 may include starting a timer when the one or more skin contact sensors detect contact with skin tissue.

[0249] In step 3506, the processing circuitry determines when a dispensing event has been initiated by the syringe assembly. This determination can be based on the position or movement of the piston within the syringe assembly. For example, the processing circuitry can determine that a dispensing event has been initiated when the syringe assembly sensor detects that the piston has begun to slide proximally along the longitudinal axis of the syringe assembly, or when the piston occupies a proximal position from its initial position when the syringe assembly is filled with medication. The position and / or movement of the piston can be determined using magnetometers 112 and / or 118 (see [link to relevant documentation]). Figure 11 Alternatively or additionally, this determination can be made based on the position or movement of the entire syringe assembly. For example, when the syringe assembly sensor detects that the syringe assembly has moved from the storage position to the injection position, the processing circuitry can determine that the syringe assembly has initiated a dispensing event. This movement can be detected using any sensor or method disclosed herein, such as the microswitch sensor 116 (see [link to related document]). Figure 9A ) and / or syringe position detector switch 1710 (see Figure 17A , 17B 19, 20). In some embodiments, an accelerometer (such as accelerometer 2012, see 19, 20) Figure 21A This can be used to detect impacts applied to the injection device as the syringe assembly moves from its storage position or is driven to its injection position. Optionally, the skin contact sensor can also be used in conjunction with an accelerometer to provide further accuracy in determining when the syringe assembly has initiated a dispensing event—an embodiment of using a skin contact sensor in conjunction with an accelerometer to detect the initiation and / or completion of a dispensing event has already been described above regarding… Figure 28-32 The discussion has been conducted. In some embodiments, step 3506 may include recording a timestamp in memory corresponding to the point in time when the syringe assembly initiates a dispensing event. Alternatively or additionally, step 3506 may include a stop timer that is activated when one or more skin contact sensors detect contact with skin tissue.

[0250] In step 3508, the processing circuitry measures a first duration between when the at least one skin contact sensor detects contact with skin tissue and when the syringe assembly initiates a dispensing event. This measurement can be accomplished by subtracting the timestamp corresponding to when the one or more skin contact sensors detect contact with skin tissue from the timestamp corresponding to when the syringe assembly initiates a dispensing event. Alternatively or additionally, step 3508 may include reading the value of a timer that starts when one or more skin contact sensors detect contact with skin tissue and stops when the syringe assembly initiates a dispensing event.

[0251] In step 3510, the processing circuit compares the first duration with a first pre-programmed threshold duration (e.g., 1 second, 3 seconds, 5 seconds). In step 3512, when the first duration is greater than the first threshold duration, the processing circuit may generate a first user indication signal. The user indication signal may indicate that the user of the drug delivery device may have a relatively low level of proficiency and / or experience in operating the drug delivery device. This is because experienced or skilled users of the drug delivery device may initiate a dispensing event shortly after placing the delivery device against the skin tissue. The fact that the user delays in initiating a dispensing event after placing the device against the skin may indicate that the user has spent an excessive amount of time checking and repeatedly verifying that the device is correctly placed, rereading the instructions for using the delivery device, and / or unlocking the device to initiate a dispensing event. In some embodiments, the first user indication signal is generated only if the first duration is greater than the first threshold duration.

[0252] Figure 36 This is a flowchart depicting another exemplary process 3600, used to generate an indication of whether a user of any of the injection devices disclosed herein possesses a high or low level of proficiency or experience in operating the injection device. Specifically, process 3600 generates an indication of whether the user can determine when the injection device has completed a dispensing event. Some of the injection devices disclosed herein incorporate mechanical features that allow the user to indicate when a dispensing event has been completed. For example, when the syringe assembly moves from the injection position to the retracted position at the end of a dispensing event, the user may be able to feel the impact of the movement of the syringe assembly in his / her hand and hear an audible click from the movement of the syringe assembly. In embodiments where the device housing is wholly or partially transparent, the user may be able to visually see the movement of the syringe assembly as it moves from the injection position to the retracted position. An experienced or sophisticated user who can see, hear, and / or feel any of the aforementioned mechanical indicators can be expected to remove the injection device from the injection site shortly after the dispensing event has been completed. If the user does not remove the injection site within a specific time period after the assignment event has been completed, this may indicate that the user cannot see, hear, and / or feel the aforementioned mechanical indicators (e.g., due to reduced sensory acuity), is unaware of looking for any of the aforementioned mechanical indicators, or is unaware that the aforementioned indicators indicate that the assignment event has been completed.

[0253] Process 3600 begins at step 3614, where the processing circuitry determines when the syringe assembly has completed a dispensing event. This determination can be based on the position or movement of the piston within the syringe assembly's barrel. For example, the processing circuitry can determine that the syringe assembly has completed a dispensing event when the syringe assembly sensor detects that the piston has completed movement along the barrel of the syringe assembly in the proximal direction, or when the piston occupies a position along the barrel indicating a completed dispensing event. Alternatively or additionally, this determination can be based on the position or movement of the entire syringe assembly. For example, the processing circuitry can determine that the syringe assembly has completed a dispensing event when the syringe assembly sensor detects that the syringe assembly has moved from the injection position to the retracted position. Such movement of the syringe assembly can be detected using any sensor or method disclosed herein, such as the microswitch sensor 116 (see [link to sensor]). Figure 9A ) and / or syringe position detector switch 1710 (see Figure 17A , 17B 19, 20). In some embodiments, an accelerometer (such as accelerometer 2012, see 19, 20) Figure 21A This can be used to detect the impact imparted to the injection device as the syringe assembly moves from the injection position or is driven to the retracted position. Optionally, as discussed above, the skin contact sensor can also be used in conjunction with an accelerometer to provide further accuracy in determining when the syringe assembly has completed the dispensing event. In some embodiments, step 3614 may include recording a timestamp in memory corresponding to the time point when the syringe assembly completes the dispensing event. Alternatively or additionally, step 3614 may include starting a timer when the syringe assembly completes the dispensing event.

[0254] In step 3616, the processing circuitry determines when the at least one skin contact sensor stops detecting contact with skin tissue. This determination can be made by detecting when the skin contact sensor transitions from a state where skin contact was detected to a state where no skin contact was detected. In some embodiments, step 3616 may include recording a timestamp in memory corresponding to the point in time when the at least one skin contact sensor stops detecting contact with skin tissue. Alternatively or additionally, step 3616 may include stopping a timer that was started when the syringe assembly completes a dispensing event.

[0255] In step 3618, the processing circuit measures a second duration between the time the syringe assembly completes the dispensing event and the time when the at least one skin contact sensor stops detecting contact with the skin tissue. This measurement can be performed by subtracting the timestamp corresponding to the time when the syringe assembly completes the dispensing event from the timestamp corresponding to the time when the at least one skin contact sensor stops detecting contact with the skin tissue. This subtraction operation can be performed on the injection device or on a mobile device that is wirelessly connected to the injection device. In some embodiments, this measurement can be performed by simply reading the value of a timer started in step 3614 and stopped in step 3616.

[0256] In step 3620, the processing circuit compares the second duration with a second pre-programmed threshold duration (e.g., 1 second, 3 seconds, 5 seconds, 10 seconds). In step 3622, when the second duration is greater than the second threshold duration, the processing circuit may generate a second user indication signal. The second user indication signal may indicate that the user of the drug delivery device cannot see, hear, and / or feel any mechanical indicators that may accompany the completion of the dispensing event, and / or the user does not understand the importance of the aforementioned mechanical indicators. In some embodiments, the second user indication signal may only be generated if the second duration is greater than the second threshold duration. In other embodiments, the second user indication signal may also be generated under other circumstances. In some embodiments, the second user indication signal may be the same signal as the first user indication signal.

[0257] Figure 37 This is a flowchart depicting another exemplary process 3700, used to generate an indication of whether a user of any of the drug delivery devices disclosed herein has a high or low level of proficiency or experience in operating the injection device. Specifically, process 3700 determines whether a user might misuse the drug delivery device by attempting to return the base cover of the device to its original position. For some of the injection devices disclosed herein, the user may be instructed not to remove and then return the base cover (e.g., base cover 36) covering the injection needle of the injection device without initiating and / or completing the dispensing event. This is because removing and then returning the base cover may bend or otherwise damage the injection needle. For such injection devices, it is generally recommended not to remove the base cover until shortly before initiating and completing the dispensing event. If it is necessary to remove the base cover prematurely before injection, the entire injection device should be discarded. Therefore, removing and then returning the base cover without initiating and / or completing the dispensing event is a misuse of such an injection device. While this may be clear to the user from the instructions for using the device, it would be preferable to implement measures to automatically detect such misuse of the injection device.

[0258] Process 3700 begins at step 3702, where a drug delivery device is provided. An example of a suitable drug delivery device is device 20, including any embodiments thereof disclosed herein. The provided drug delivery device may include a device housing defining an internal volume and an opening (e.g., opening 40) communicating with the internal volume, and a syringe assembly at least partially disposed within the internal volume. The syringe assembly may include a barrel configured to hold a drug and an injection needle extending from the barrel. The device may also include a movable base cap (e.g., base cap 36) configured to cover the opening. The device may also include one or more syringe assembly sensors and one or more base cap sensors, the syringe assembly sensors being configured to detect at least one of position and movement of at least a portion of the syringe assembly, and the base cap sensors being configured to detect when the movable base cap is removed from the opening. Suitable examples of syringe assembly sensors include magnetometers 112 and / or 118, microswitches 116 and / or syringe position detector switches 1710, and / or one or more accelerometers 2012, as previously discussed. Suitable examples of base cover sensors include base cover removal sensors 2010.

[0259] In step 3704, the processing circuit monitors data output from one or more syringe assembly sensors to detect when the syringe assembly initiates or completes a dispensing event. Any method described herein for determining the initiation and / or completion of a dispensing event can be used. In step 3706, the processing circuit monitors data output from one or more base cap sensors to determine whether the base cap covers the opening.

[0260] In step 3708, when data from one or more base cap sensors indicates that the movable base cap has been removed from the opening and then subsequently returned to cover the opening before the syringe assembly initiates or completes a dispensing event, the processing circuitry generates a misuse indication signal. The misuse indication signal can indicate that the user is misusing the injection device in a manner that could damage the injection needle and impair device performance. In some embodiments, the misuse indication signal is generated only if the injection device's sensors detect that the base cap has been removed and subsequently returned to its original position before the syringe assembly initiates or completes a dispensing event.

[0261] In other embodiments, the misuse indication signal may also be generated under other circumstances. For example, even after the dispensing event has been completed, one or more processing circuits may generate a misuse indication signal if the device detects that the user is attempting to put the base cover back in place. In other words, in some embodiments, a misuse indication signal may be generated if the user attempts to put the base cover back in place after removing it, regardless of whether the dispensing event has been initiated and / or completed. This is because, in some embodiments, the user may be instructed to place the injection device in the sharps container without attempting to put the base cover back in place, as doing so could result in an accidental needle prick. If the user attempts to put the base cover back in place even after the dispensing event has been completed, the device can detect such an attempt and mark or record it as misuse of the device. In some embodiments, putting the base cover back in place after the dispensing event has been completed may result in the generation of a second misuse indication signal, different from the first misuse indication signal.

[0262] Figure 38 This is a flowchart depicting another exemplary process 3800, used to generate an indication of whether a user of the drug delivery device has a high or low level of proficiency or experience in operating the injection device. Specifically, if the injection device detects multiple instances of skin contact sensors detecting contact with skin tissue but no dispensing event is initiated before the skin contact is broken, process 3800 generates a user indication signal. This could indicate to the user that they are unsure which injection site to use, and at which injection site to place the device multiple times and remove the device from the patient's body. An experienced user would be expected to make a firm device-skin contact at an injection site and move quickly to initiate an injection or dispensing event; the fact that multiple skin contacts were detected without injection indicates that the user may be inexperienced or unsure.

[0263] Process 3800 begins at step 3802, where a drug delivery device is provided. The provided delivery device may be similar to that described above. Figure 35 The device type discussed in step 3502 of process 3500.

[0264] In step 3804, the processing circuit counts the number of proximity events that occur before the initiation of a dispensing event is detected by one or more syringe assembly sensors. As used herein, a proximity event is defined as an event in which the one or more skin contact sensors detect contact with skin tissue and then subsequently cease detecting contact with skin tissue. Once the processing circuit detects the initiation of a dispensing event, it can stop counting the number of detected proximity events. The initiation of a dispensing event can be determined using any of the methods discussed above with respect to step 3506 of process 3500.

[0265] In step 3806, the processing circuit compares the number of proximity events with a pre-programmed maximum threshold, such as one, three, five or more events.

[0266] In step 3808, when the number of proximity events exceeds a pre-programmed maximum threshold, the processing circuit generates a user indication signal. For example, the processing circuit can generate a user indication signal when the number of proximity events exceeds zero, one, two, three, or four proximity events.

[0267] Figure 39 This is a flowchart depicting another exemplary process 3900 for generating an indication of whether a user of any drug delivery device disclosed herein has a high or low level of skill or experience in operating the injection device. Specifically, process 3900 determines whether the user may inappropriately remove the device from the patient's skin during a dispensing event. If the skin contact sensor detects a break in contact with the skin during injection, i.e., after the dispensing event is initiated but before it is completed, a user indication signal (indicating a low level of skill or experience) can be generated. Such premature removal could indicate a potentially incomplete dose, as well as a lack of experience or uncertainty on the part of the user.

[0268] Process 3900 begins at step 3902, in which a drug delivery device is provided. The provided delivery device may be similar to that described above. Figure 35 The device type discussed in step 3502 of process 3500.

[0269] In step 3904, the processing circuitry determines when the syringe assembly initiates a dispensing event and when the syringe assembly completes a dispensing event. These determinations may be based, at least in part, on syringe assembly sensor signals output by one or more syringe assembly sensors disposed on the drug delivery device. The initiation of the dispensing event may be detected by the processing circuitry using any of the methods discussed above regarding step 3506 of process 3500. The completion of the dispensing event may be detected by the processing circuitry using any of the methods discussed above regarding step 3506 of process 3500. Figure 36 Step 3614 of process 3600 discusses any method for detection.

[0270] In step 3906, the processing circuitry processes one or more skin detection signals from one or more skin contact sensors on the drug delivery device. The processed signals can be received after the distribution event is initiated and before it is completed; that is, the processed signals can be received during or while the distribution event is in progress. In step 3908, when data indicating skin contact continuity meets one or more pre-programmed criteria, the processing circuitry generates a user instruction signal.

[0271] The processing circuitry processes this signal to generate data indicating the continuity of skin contact during the assignment event. At this step, the processing circuitry can use different measurements indicating the continuity of skin contact. For example, the processing circuitry can count the number of lift-off events, where each lift-off event includes an event in which the one or more skin contact sensors transition from a state in which skin contact was detected to a state in which skin contact was not detected. In such an embodiment, if the number of lift-off events exceeds a pre-programmed maximum threshold, such as zero, one, two, three, four, or five lift-off events, the processing circuitry can generate a user indication signal.

[0272] Alternatively or additionally, the processing circuitry may calculate the ratio of the amount of time during which skin contact was detected to the amount of time during which skin contact was not detected. In such an embodiment, if the calculated ratio is below a pre-programmed threshold, the processing circuitry may generate a user indication signal.

[0273] Alternatively or additionally, the processing circuitry may calculate the ratio of the amount of time during which skin contact is detected to the total duration of the assigned events. In such an embodiment, if the calculated ratio is less than a pre-programmed threshold, the processing circuitry may generate a user indication signal.

[0274] Alternatively or additionally, the processing circuitry may calculate the ratio of the amount of time during which no skin contact was detected to the total duration of the assigned events. In such an embodiment, if the calculated ratio is greater than a pre-programmed threshold, the processing circuitry may generate a user indication signal.

[0275] Alternatively or additionally, if the amount of time during which no skin contact is detected exceeds a pre-programmed threshold during the assigned event, the processing circuitry may generate a user indication signal.

[0276] Figure 40This is a flowchart depicting yet another exemplary process 4000 for generating an indication of whether a user of any drug delivery device disclosed herein possesses a high or low level of proficiency or experience in operating the injection device. Specifically, process 4000 determines whether the user initiates a dispensing event within a certain threshold time after the repositioning of the base cap. A skilled or experienced user would be expected to initiate a dispensing event quickly after the repositioning of the base cap. However, a user with a low level of proficiency or experience may wait longer after the repositioning of the base cap to initiate a dispensing event, possibly because the user is checking or repeatedly checking the device's instructions for use, locating an appropriate injection site on the patient, or is unsure how to operate the device for other reasons. In particular, waiting a long time after the repositioning of the base cap to initiate a dispensing event may increase the risk of contamination of the exposed sterile needle. A long wait may also increase the risk that the liquid drug product stored in the cartridge may dry out and partially or completely clog the needle, thus hindering drug delivery.

[0277] Process 4000 begins at step 4002, in which a drug delivery device is provided. The provided delivery device may be similar to that described above. Figure 37 The device type discussed in step 3702 of process 3700.

[0278] In step 4004, the processing circuit monitors data output from the one or more syringe assembly sensors to detect when the syringe assembly initiates a dispensing event. Any method described herein for determining the initiation and / or completion of a dispensing event can be used. In step 4006, the processing circuit monitors data output from the one or more base cap sensors to determine whether the base cap has moved from an opening in the housing through which the needle of the syringe assembly extends when the syringe assembly moves to the injection position.

[0279] In step 4008, if the syringe assembly does not initiate a dispensing event within a threshold time after the base cap has moved from the opening, the processing circuit generates a user indication signal. This can be accomplished by starting a timer after the base cap sensor detects that the base cap has been moved. If the processing circuit does not detect the initiation of a dispensing event when the timer expires (or until the timer reaches a certain threshold duration), the processing circuit can generate a user indication signal. Alternatively or additionally, the processing circuit can record a first timestamp associated with the time when the base cap has moved, and a second timestamp associated with the time when the syringe assembly initiated a dispensing event. The processing circuit can then calculate the difference between the first and second timestamps. If this difference is greater than the threshold duration, the processing circuit can generate a user indication signal.

[0280] As previously discussed, each of processes 3500, 3600, 3700, 3800, 3900, and 4000 can be implemented on one or more processing circuits, which are either entirely located on the injection device or on both the injection device and an external device that communicates wirelessly with the injection device. In embodiments where the process is implemented by both the injection device and the external device, various types of data can be transferred between the injection device and the external device to perform processes 3500, 3600, 3700, 3800, 3900, and 4000. For example, the injection device can periodically (e.g., every second, every few seconds, or multiple times per second) transmit data packets to the external device containing information about: (a) whether a dispensing event has been initiated, (b) whether a dispensing event has been completed, (c) skin contact has been detected, and / or (d) the position of the base cap (e.g., open or closed) at the time the data packet is transmitted. In some embodiments, the injection device may not begin transmitting such data packets until the base cap is removed, or until after a dispensing event has been initiated. In other embodiments, the injection device may wait until the injection event has been completed before sending a data packet. In such embodiments, the data packet may contain a timestamp indicating when the base cover was removed and / or when the allocation event was initiated. Upon receiving such a data packet, the external device then executes logic to determine whether the various conditions of processes 3500, 3600, 3700, 3800, 3900, and 4000 described above are met, and if so, generates the aforementioned user instruction signal or misuse indication signal. In some embodiments, the logic for checking whether some or all of the aforementioned conditions for processes 3500, 3600, 3700, 3800, 3900, and 4000 are met is not implemented on the external device, but on one or more processing circuits within the injection device. In such embodiments, the injection device may send one or more data packets containing the user instruction and / or misuse indication signals as described above.

[0281] Each user instruction signal (and / or misuse indication signal) generated by each of processes 3500, 3600, 3700, 3800, 3900, and 4000 may be transmitted to a respective destination and / or cause different actions or responses from processing circuitry or from devices communicating with one or more processing circuitry. Some of the aforementioned user instruction signals and / or misuse indication signals may be the same signal or may trigger the same response from one or more processing circuitry. In some embodiments, each of these signals may cause the one or more processing circuitry to display or play instructions on how to properly use the injection device. For example, in process 3500, a first user instruction signal may cause a mobile application on a user's mobile device (e.g., external device 1250) to display a screen showing instructions or providing the user with one or more instructive video or audio messages on how to unlock, place, and activate the drug delivery device; similarly, a second user instruction signal in process 3600 may cause a mobile application to display a screen and / or message on how to determine when the drug delivery device has completed dispensing events. The misuse indication signal in process 3700 may prompt a mobile application to display a screen and / or message warning the user that replacing the base cap after removal may damage the needle, and / or suggesting that the medication delivery device should be activated shortly thereafter once the base cap is removed. In some embodiments, the user indication signal and / or misuse indication signal may cause the user's mobile device to display a suggestion or prompt to contact a help desk agent (e.g., via a telephone line or chat line). The user indication signal and / or misuse indication signal may also prompt the injection device itself to provide additional instructions, such as one or more pre-recorded audio messages played through a speaker mounted on the injection device.

[0282] Alternatively or additionally, user instruction signals and / or misuse indication signals may be transmitted via a network (e.g., via the Internet or cellular networks) to a remote server or device, for example, in the form of text messages, push notifications, emails, or other remote electronic notifications. The remote server or device may be associated with the user's care provider, such as a nurse, registered nurse, doctor, family member, or other care provider. In this case, the user instruction signals and / or misuse indication signals may indicate to the care provider that the user may require additional supervision or assistance when using the medication delivery device. In other embodiments, the remote server or device may be associated with the manufacturer, designer, distributor, or payer of the injection device. In this case, the user instruction signals and / or misuse indication signals may provide such an entity with real-world evidence regarding how the user uses the injection device. When compiled among a group of injection device users, this real-world evidence may inform decisions regarding whether to compensate for such an injection device (and if so, at what rate and under what conditions), whether / how to redesign such an injection device, and / or whether additional instructions or training are required for effective use. User instruction signals and / or misuse indication signals may also be recorded and tracked for individual users or groups of users. Ideally, as users become more familiar with and / or proficient with the injection device, the occurrence of user instruction signals and / or misuse instruction signals should decrease over time. If the occurrence of such signals does not decrease, or does not decrease as rapidly as expected, the manufacturer, designer, distributor, and / or payer of the injection device may consider implementing additional actions, such as redesigning the injection device, or providing additional instructions or training.

[0283] While the invention has been described with exemplary design, embodiments of this disclosure may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the disclosed embodiments using its general principles.

[0284] Several aspects were disclosed, including but not limited to the following:

[0285] 1. A drug delivery system comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more syringe assembly sensors disposed within the housing, configured to be based on the syringe assembly. The device outputs a syringe assembly sensor signal based on at least one of the positions of at least a portion of the component and the movement of at least a portion of the syringe assembly; and one or more processing circuits configured to: determine when one or more skin contact sensors detect contact with skin tissue; determine when the syringe assembly initiates a dispensing event based at least in part on the syringe assembly sensor signal; measure a first duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates a dispensing event; compare the first duration with a first pre-programmed threshold duration; and generate a first user indication signal when the first duration is greater than the first threshold duration.

[0286] 2. The drug delivery system according to aspect 1, wherein: the syringe assembly further includes a piston configured to slide along a longitudinal axis within the syringe body to eject the drug from the injection needle; a syringe assembly sensor signal is based on the position of the piston; and the one or more processing circuits are configured to determine, based on the position of the piston, when the syringe assembly has initiated a dispensing event.

[0287] 3. The drug delivery system according to aspect 1, wherein the drive mechanism is configured to move the syringe assembly from a storage position to an injection position, wherein the injection needle extends at least partially out of the opening.

[0288] 4. The drug delivery system according to aspect 3, wherein the one or more processing circuits are configured to determine when the syringe assembly has initiated a dispensing event by determining when the syringe assembly has moved from the storage location to the injection location.

[0289] 5. The drug delivery system according to aspect 4, wherein the one or more syringe assembly sensors include a syringe position detector switch.

[0290] 6. The drug delivery system according to any one of aspects 4-5, wherein the one or more syringe assembly sensors include an accelerometer configured to output a syringe assembly sensor signal based on sensed acceleration caused by motion of the syringe assembly; and the one or more processing circuits are configured to determine, at least in part, when the syringe assembly has initiated a dispensing event based on the sensed acceleration.

[0291] 7. The drug delivery system according to any one of aspects 1-6, wherein at least one of the one or more processing circuits is disposed within the device housing.

[0292] 8. The drug delivery system according to any one of aspects 1-7, wherein at least one of the one or more processing circuits is disposed within a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

[0293] 9. The drug delivery system according to aspects 1-8, wherein the one or more processing circuits are further configured to display or play instructions on how to use the drug delivery system in response to the first user instruction signal.

[0294] 10. The drug delivery system according to any one of aspects 1-9, wherein the one or more processing circuits are configured to send a first user instruction signal to a remote device via a network.

[0295] 11. The drug delivery system according to any one of aspects 1-10, wherein the one or more processing circuits are further configured to: determine, at least in part based on the syringe assembly sensor signals, when the syringe assembly completes a dispensing event; determine when the one or more skin contact sensors cease detecting contact with skin tissue; measure a second duration between when the syringe assembly completes the dispensing event and when the one or more skin contact sensors cease detecting contact with skin tissue; compare the second duration with a second pre-programmed threshold duration; and generate a second user indication signal when the second duration is greater than the second threshold duration.

[0296] 12. The drug delivery system according to aspect 11, wherein the one or more processing circuits are further configured to display or play instructions on how to determine when the syringe assembly has completed dispensing in response to the second user instruction signal.

[0297] 13. The drug delivery system according to any one of aspects 11-12, wherein the one or more processing circuits are configured to transmit the second user instruction signal to a remote device via a network.

[0298] 14. The drug delivery system according to any one of aspects 1-13, wherein the cylinder holds the drug.

[0299] 15. A method for generating instructions for a user of a drug delivery device, the device comprising: a device housing defining an internal volume and an opening communicating with the internal volume; a syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event in which the syringe assembly dispenses the drug from the injection needle as the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more syringe assemblies disposed within the device housing. A sensor configured to output an injection cartridge assembly sensor signal based on at least one of the position of at least a portion of the injection cartridge assembly and the movement of at least a portion of the injection cartridge assembly, the method comprising: determining when the one or more skin contact sensors detect contact with skin tissue; determining when the injection cartridge assembly initiates a dispensing event based at least in part on the injection cartridge assembly sensor signal; measuring a first duration between when the at least one skin contact sensor detects contact with skin tissue and when the injection cartridge assembly initiates a dispensing event; comparing the first duration with the first pre-programmed threshold duration; and generating a first user indication signal when the first duration is greater than the first threshold duration.

[0300] 16. The method according to aspect 15 further includes displaying or playing instructions on how to use the drug delivery device in response to a first user instruction signal.

[0301] 17. The method according to any one of aspects 15-16 further includes sending a first user instruction signal to a remote device via a network.

[0302] 18. The method according to any one of aspects 15-17, further comprising: determining, at least in part, based on syringe assembly sensor signals, when a dispensing event is completed by the syringe assembly; determining when the one or more skin contact sensors cease detecting contact with skin tissue; measuring a second duration between when the syringe assembly completes the dispensing event and when the one or more skin contact sensors cease detecting contact with skin tissue; comparing the second duration with a second pre-programmed threshold duration; and generating a second user indication signal when the second duration is greater than the second threshold duration.

[0303] 19. The method according to aspect 18 further includes displaying or playing instructions on how to determine when the syringe assembly has completed dispensing in response to a second user instruction signal.

[0304] 20. The method according to any one of aspects 18-19 further includes transmitting a second user instruction signal to a remote device via a network.

[0305] 21. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform any of the methods according to any one of aspects 15-20.

[0306] 22. A drug delivery system comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an injection cartridge assembly at least partially disposed within the internal volume, the injection cartridge assembly including a cartridge body configured to hold a drug and an injection needle extending from the cartridge body; a movable base cap configured to cover the opening; one or more injection cartridge assembly sensors configured to output an injection cartridge assembly sensor signal based on at least one of a position of at least a portion of the injection cartridge assembly and movement of at least a portion of the injection cartridge assembly; one or more base cap sensors configured to detect when the movable base cap has been removed from the opening; and one or more processing circuitry configured to: determine when the injection cartridge assembly initiates a dispensing event based at least partially on the injection cartridge assembly sensor signal; and generate a misuse indication signal when the one or more base cap sensors detect that the movable base cap has been removed from the opening and is then subsequently returned to its original position to cover the opening before the injection cartridge assembly initiates a dispensing event.

[0307] 23. The drug delivery system according to aspect 22, wherein the one or more processing circuits are further configured to generate the misuse indication signal when the one or more base cover sensors detect that the movable base cover has been removed from the opening and is then subsequently returned to its original position to cover the opening after the syringe assembly initiates a dispensing event.

[0308] 24. The drug delivery system according to any one of aspects 22-23, wherein: the syringe assembly further includes a piston configured to slide along a longitudinal axis within the syringe body to eject the drug from the injection needle; the syringe assembly sensor signal is based on the position of the piston; and one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event based on the position of the piston.

[0309] 25. The drug delivery system according to any one of aspects 22-23, wherein the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event by determining when the syringe assembly has moved from a storage location to an injection location.

[0310] 26. The drug delivery system according to aspect 25, wherein the one or more syringe assembly sensors include a syringe position detector switch.

[0311] 27. The drug delivery system according to any one of aspects 25-26, wherein the one or more syringe assembly sensors include an accelerometer configured to output sensed acceleration caused by movement of the syringe assembly; and the one or more processing circuits are configured to determine, at least in part, when the syringe assembly initiates a dispensing event based on the sensed acceleration.

[0312] 28. The drug delivery system according to any one of aspects 22-27, wherein at least one of the one or more processing circuits is disposed within the device housing.

[0313] 29. The drug delivery system according to any one of aspects 22-28, wherein at least one of the one or more processing circuits is disposed within a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

[0314] 30. The drug delivery system according to any one of aspects 22-29, wherein the one or more processing circuits are further configured to display or play instructions for using the drug delivery system in response to a misuse indication signal.

[0315] 31. The drug delivery system according to any one of aspects 22-30, wherein the one or more processing circuits are configured to transmit a misuse instruction to a remote device via a network.

[0316] 32. The drug delivery system according to any one of aspects 22-31, wherein the one or more processing circuits are further configured to generate a second type of misuse indication signal when the one or more base cover sensors detect that the movable base cover has been removed from the opening and then subsequently returned to its original position to cover the opening after the syringe assembly initiates a dispensing event.

[0317] 33. The drug delivery system according to any one of aspects 22-32, wherein the cylinder holds the drug.

[0318] 34. A method for generating instructions for a user of a drug delivery device, the device comprising: a device housing defining an internal volume and an opening communicating with the internal volume; a syringe assembly at least partially disposed within the internal volume; the syringe assembly including a barrel configured to hold a drug and an injection needle extending from the barrel; a movable base cover configured to cover the opening; one or more syringe assembly sensors configured to output syringe assembly sensor signals based on at least one of a position of at least a portion of the syringe assembly and movement of at least a portion of the syringe assembly; and one or more base cover sensors configured to detect when the movable base cover has been removed from the opening, the method comprising: monitoring data output from the one or more syringe assembly sensors to detect when the syringe assembly initiates a dispensing event; monitoring syringe assembly sensor signals from the one or more base cover sensors to determine whether the base cover covers the opening; and generating a misuse instruction to a user of the drug delivery system when data from the one or more base cover sensors indicates that the movable base cover has been removed from the opening and is then subsequently returned to its original position to cover the opening before the syringe assembly initiates a dispensing event.

[0319] 35. The method according to aspect 34 further includes generating a misuse indication to the user when data from one or more base cover sensors indicates that the movable base cover has been removed from the opening and is then subsequently returned to its original position to cover the opening after a dispensing event is initiated by the syringe assembly.

[0320] 36. The method according to any one of aspects 34-35 further includes displaying or playing instructions for using the drug delivery system in response to a misuse indication signal.

[0321] 37. The method according to any one of aspects 34-36 further includes transmitting a misuse instruction to a remote device via a network.

[0322] 38. The method according to any one of aspects 34-37, further comprising generating a second type of misuse indication signal when one or more base cover sensors detect that the movable base cover has been removed from the opening and then subsequently returned to its original position to cover the opening after a dispensing event is initiated by the syringe assembly.

[0323] 39. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform the method according to any one of aspects 34-38.

[0324] 40. A drug delivery system comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an syringe assembly at least partially disposed within the internal volume, the syringe assembly including a barrel configured to hold a drug and an injection needle extending from the barrel; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more syringe assembly sensors disposed within the housing, configured to... At least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly outputs a syringe assembly sensor signal; and one or more processing circuits configured to: determine, at least in part, based on the syringe assembly sensor signal, when the syringe assembly initiates a dispensing event; count the number of proximity events in which the one or more skin contact sensors detect contact with skin tissue and then subsequently stop detecting contact with skin tissue before the syringe assembly initiates a dispensing event; compare the number of proximity events with a pre-programmed maximum threshold; and generate a user indication signal when the number of proximity events is greater than the pre-programmed maximum threshold.

[0325] 41. The drug delivery system according to aspect 40, wherein: the syringe assembly further includes a piston configured to slide along a longitudinal axis within the syringe body to eject the drug from the injection needle; the syringe assembly sensor signal is based on the position of the piston; and the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event based on the position of the piston.

[0326] 42. The drug delivery system according to aspect 40, wherein the drive mechanism is configured to move the syringe assembly from a storage position to an injection position, in which the injection needle extends at least partially out of the opening.

[0327] 43. The drug delivery system according to aspect 42, wherein the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event by determining when the syringe assembly has moved from a storage location to an injection location.

[0328] 44. The drug delivery system according to aspect 43, wherein the one or more syringe assembly sensors include a syringe position detector switch.

[0329] 45. The drug delivery system according to any one of aspects 43-44, wherein the one or more syringe assembly sensors include accelerometers configured to output syringe assembly sensor signals based on sensed acceleration caused by motion of the syringe assembly; and the one or more processing circuits are configured to determine, at least in part, when the syringe assembly initiates a dispensing event based on the sensed acceleration.

[0330] 46. ​​The drug delivery system according to any one of aspects 40-45, wherein at least one of the one or more processing circuits is disposed within the device housing.

[0331] 47. The drug delivery system according to any one of aspects 40-46, wherein at least one of the one or more processing circuits is disposed within a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

[0332] 48. The drug delivery system according to any one of aspects 40-47, wherein the one or more processing circuits are further configured to display or play instructions on how to use the drug delivery system in response to a user instruction signal.

[0333] 49. The drug delivery system according to any one of aspects 40-48, wherein the one or more processing circuits are configured to transmit user instruction signals to a remote device via a network.

[0334] 50. The drug delivery system according to any one of aspects 40-49, wherein the cylinder holds the drug.

[0335] 51. A method for generating a user instruction regarding a drug delivery device, the device comprising: a device housing defining an internal volume and an opening communicating with the internal volume; a syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cylinder configured to hold a drug and an injection needle extending from the cylinder; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle as the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and one or more syringe assembly sensors disposed within the device housing, configured to detect the initiation of a dispensing event using the syringe assembly, the method comprising: counting the number of proximity events in which the one or more skin contact sensors detect contact with skin tissue and then subsequently stop detecting contact with skin tissue before the one or more syringe assembly sensors detect the initiation of a dispensing event; comparing the number of proximity events with a pre-programmed maximum threshold; and generating a user instruction signal when the number of proximity events is greater than the pre-programmed maximum threshold.

[0336] 52. The method according to aspect 51 further includes displaying or playing instructions on how to use the drug delivery device in response to a user instruction signal.

[0337] 53. The method according to any one of aspects 51-52 further includes transmitting a user instruction signal to a remote device via a network.

[0338] 54. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform any of the methods according to any one of aspects 51-53.

[0339] 55. A drug delivery system comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to output a skin detection signal when contact with skin tissue is detected; and one or more syringe assemblies disposed within the housing. A syringe assembly sensor is configured to output a syringe assembly sensor signal based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly; and one or more processing circuits are configured to: determine, at least in part based on the syringe assembly sensor signal, when the syringe assembly initiates a dispensing event and when the syringe assembly completes a dispensing event; process one or more skin detection signals received from the one or more skin contact sensors after the dispensing event is initiated and before the dispensing event is completed to derive data indicating the continuity of skin contact during the dispensing event; and generate a user indication signal when the data meets one or more pre-programmed criteria.

[0340] 56. The drug delivery system according to aspect 55, wherein: the derived data includes a plurality of lift-off events, wherein each lift-off event includes an event in which the one or more skin contact sensors transition from a state in which skin contact is detected to a state in which skin contact is not detected; and when the number of lift-off events exceeds a pre-programmed threshold, the one or more processing circuits generate a user instruction signal.

[0341] 57. The drug delivery system according to aspect 55, wherein: the derived data includes a ratio of the amount of time in which skin contact was detected to the amount of time in which skin contact was not detected; and when the ratio is less than a pre-programmed threshold, the one or more processing circuits generate a user instruction signal.

[0342] 58. The drug delivery system according to aspect 55, wherein: the derived data includes a ratio of the amount of time in which skin contact is detected to the total duration of the delivery event; and when the ratio is less than a pre-programmed threshold, the one or more processing circuits generate a user instruction signal.

[0343] 59. The drug delivery system according to aspect 55, wherein: the derived data includes a ratio of the amount of time during which no skin contact was detected to the total duration of the delivery event; and when the ratio is greater than a pre-programmed threshold, the one or more processing circuits generate a user instruction signal.

[0344] 60. The drug delivery system according to aspect 55, wherein: the derived data includes the amount of time during which no skin contact was detected during the delivery event; and when the amount of time is greater than a pre-programmed threshold, one or more processing circuits generate a user instruction signal.

[0345] 61. The drug delivery system according to any one of aspects 55-59, wherein: the syringe assembly further includes a piston configured to slide along a longitudinal axis within the syringe body to eject the drug from the injection needle; the syringe assembly sensor signal is based on the position of the piston; and the one or more processing circuits are configured to determine, based on the position of the piston, when the syringe assembly initiates a dispensing event and when the dispensing event is completed.

[0346] 62. The drug delivery system according to any one of aspects 55-59, wherein the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event and completes a dispensing event based on the position of the syringe assembly.

[0347] 63. The drug delivery system according to aspect 62, wherein the one or more syringe assembly sensors include a syringe position detector switch.

[0348] 64. The drug delivery system according to any one of aspects 62-63, wherein: the one or more syringe assembly sensors include accelerometers configured to output syringe assembly sensor signals based on sensed acceleration caused by the motion of the syringe assembly; and the one or more processing circuits are configured to determine, at least in part, when the syringe assembly initiates a dispensing event and completes a dispensing event based on the sensed acceleration.

[0349] 65. The drug delivery system according to any one of aspects 55-64, wherein at least one of the one or more processing circuits is disposed within the device housing.

[0350] 66. The drug delivery system according to any one of aspects 55-65, wherein at least one of the one or more processing circuits is disposed within a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

[0351] 67. The drug delivery system according to any one of aspects 55-66, wherein the one or more processing circuits are further configured to display or play instructions on how to use the drug delivery system in response to a user instruction signal.

[0352] 68. The drug delivery system according to any one of aspects 55-67, wherein the one or more processing circuits are configured to transmit user instruction signals to a remote device via a network.

[0353] 69. The drug delivery system according to any one of aspects 55-68, wherein the cylinder holds the drug.

[0354] 70. A method for generating instructions for a user of a drug delivery device, the device comprising: a device housing defining an internal volume and an opening communicating with the internal volume; a syringe assembly at least partially disposed within the internal volume, the syringe assembly including a cartridge configured to hold a drug and an injection needle extending from the cartridge; a drive mechanism configured to initiate a dispensing event, in which the syringe assembly dispenses the drug from the injection needle as the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; and disposed within the device housing. One or more syringe assembly sensors, configured to output syringe assembly sensor signals based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly, the method comprising: determining, at least in part based on the syringe assembly sensor signals, when the syringe assembly initiates a dispensing event and when the syringe assembly completes a dispensing event; processing one or more skin detection signals received from the one or more skin contact sensors after the dispensing event is initiated and before the dispensing event is completed, to derive data indicating the continuity of skin contact during the dispensing event; and generating a user indication signal when the data meets one or more pre-programmed criteria.

[0355] 71. The method according to aspect 70, wherein: the derived data includes a plurality of lift-off events, wherein each lift-off event includes an event in which the one or more skin contact sensors transition from a state in which skin contact is detected to a state in which skin contact is not detected; and a user indication signal is generated when the number of lift-off events exceeds a pre-programmed threshold.

[0356] 72. The method according to aspect 70, wherein: the derived data includes a ratio of the amount of time in which skin contact was detected to the amount of time in which skin contact was not detected; and a user indication signal is generated when the ratio is less than a pre-programmed threshold.

[0357] 73. The method according to aspect 70, wherein: the derived data includes a ratio of the amount of time during which skin contact was detected to the total duration of the assigned event; and when the ratio is less than a pre-programmed threshold, a user indication signal is generated.

[0358] 74. The method according to aspect 70, wherein: the derived data includes the ratio of the amount of time in which no skin contact was detected to the total duration of the assigned event; and when the ratio is greater than a pre-programmed threshold, a user indication signal is generated.

[0359] 75. The method according to aspect 70, wherein: the derived data includes the amount of time during which no skin contact was detected during the assignment event; and when the amount of time is greater than a pre-programmed threshold, a user indication signal is generated.

[0360] 76. The method according to any one of aspects 70-74 further includes displaying or playing instructions on how to use the drug delivery system in response to a user instruction signal.

[0361] 77. The method according to any one of aspects 70-76 further includes transmitting a user instruction signal to a remote device via a network.

[0362] 78. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform any of the methods according to any one of aspects 70-77.

[0363] 79. A drug delivery system comprising: a device housing defining an internal volume and an opening communicating with the internal volume; an syringe assembly at least partially disposed within the internal volume, the syringe assembly including a barrel configured to hold a drug and an injection needle extending from the barrel; a movable base cap configured to cover the opening; one or more syringe assembly sensors configured to output syringe assembly sensor signals based on at least one of a position of at least a portion of the syringe assembly and movement of at least a portion of the syringe assembly; one or more base cap sensors configured to detect when the movable base cap has moved from the opening; and one or more processing circuits configured to: determine when the movable base cap has been removed from the opening based on data output from the one or more base cap sensors; determine when the syringe assembly initiates a dispensing event based at least partially on the syringe assembly sensor signals; and generate a user instruction signal when the syringe assembly does not initiate a dispensing event within a threshold time after the base cap has moved from the opening.

[0364] 80. The drug delivery system according to aspect 79, wherein: the syringe assembly further includes a piston configured to slide along a longitudinal axis within the syringe body to eject the drug from the injection needle; the syringe assembly sensor signal is based on the position of the piston; and the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event based on the position of the piston.

[0365] 81. The drug delivery system according to any one of aspects 79-80, wherein the one or more processing circuits are configured to determine when the syringe assembly initiates a dispensing event by determining when the syringe assembly has moved from a storage location to an injection location.

[0366] 82. The drug delivery system according to aspect 81, wherein the one or more syringe assembly sensors include a syringe position detector switch.

[0367] 83. The drug delivery system according to any one of aspects 81-82, wherein the one or more syringe assembly sensors include an accelerometer configured to output sensed acceleration caused by the movement of the syringe assembly; and the one or more processing circuits are configured to determine, at least in part, when the syringe assembly initiates a dispensing event based on the sensed acceleration.

[0368] 84. The drug delivery system according to any one of aspects 79-83, wherein at least one of the one or more processing circuits is disposed within the device housing.

[0369] 85. The drug delivery system according to any one of aspects 79-84, wherein at least one of the one or more processing circuits is disposed within a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

[0370] 86. The drug delivery system according to any one of aspects 79-85, wherein the one or more processing circuits are further configured to display or play instructions for using the drug delivery system in response to a misuse indication signal.

[0371] 87. The drug delivery system according to any one of aspects 79-86, wherein the one or more processing circuits are configured to transmit a misuse instruction to a remote device via a network.

[0372] 88. The drug delivery system according to any one of aspects 79-87, wherein the cylinder holds the drug.

[0373] 89. A method for generating a user instruction regarding a drug delivery device, the device comprising: a device housing defining an internal volume and an opening communicating with the internal volume; a syringe assembly at least partially disposed within the internal volume, the syringe assembly including a barrel configured to hold a drug and an injection needle extending from the barrel; a movable base cover configured to cover the opening; one or more syringe assembly sensors configured to output syringe assembly sensor signals based on at least one of a position of at least a portion of the syringe assembly and movement of at least a portion of the syringe assembly; and one or more base cover sensors configured to detect when the movable base cover has been removed from the opening, the method comprising: monitoring syringe assembly sensor signals output from the one or more syringe assembly sensors to detect when the syringe assembly initiates a dispensing event; monitoring data output from the one or more base cover sensors to determine when the movable base cover has moved from the opening; and generating a user instruction signal when the syringe assembly has not initiated the dispensing event within a threshold time after the base cover has moved from the opening.

[0374] 90. The method according to aspect 89 further includes displaying or playing instructions for using the drug delivery system in response to a misuse indication signal.

[0375] 91. The method according to any one of aspects 89-90 further includes transmitting a misuse instruction to a remote device via a network.

[0376] 92. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform any of the methods according to any one of aspects 89-91.

Claims

1. A drug delivery system, comprising: A device housing that defines the internal volume and the opening communicating with the internal volume; An injection cartridge assembly, at least partially disposed within an internal volume, includes a cartridge configured to hold a drug and an injection needle extending from the cartridge. A drive mechanism configured to initiate a dispensing event in which the syringe assembly dispenses medication from the injection needle when the injection needle extends at least partially out of the opening; One or more skin contact sensors are disposed on the housing adjacent to the opening, each skin contact sensor being configured to detect contact with skin tissue; One or more syringe assembly sensors disposed within the housing are configured to output syringe assembly sensor signals based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly. and One or more processing circuits are configured as follows: Determine when the one or more skin contact sensors detect contact with skin tissue; The timing of the dispensing event is determined, at least in part, based on the sensor signals from the syringe assembly. The measurement determines the first duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates a dispensing event. Compare the first duration with the first pre-programmed threshold duration, and When the first duration is greater than the first pre-programmed threshold duration, a first user indication signal is generated.

2. The drug delivery system according to claim 1, wherein: The syringe assembly also includes a piston configured to slide along a longitudinal axis within the syringe to expel the drug from the injection needle. The syringe assembly sensor signal is based on the position of the piston; and The one or more processing circuits are configured to determine, based on the position of the piston, when the syringe assembly has initiated a dispensing event.

3. The drug delivery system according to claim 1, wherein, The drive mechanism is configured to move the syringe assembly from a storage position to an injection position, in which the injection needle extends at least partially out of the opening.

4. The drug delivery system according to claim 3, wherein, The one or more processing circuits are configured to determine when the syringe assembly has initiated a dispensing event by determining when the syringe assembly has moved from the storage location to the injection location.

5. The drug delivery system according to claim 4, wherein, The one or more syringe assembly sensors include a syringe position detector switch.

6. The drug delivery system according to any one of claims 4-5, wherein The one or more syringe assembly sensors include accelerometers configured to output syringe assembly sensor signals based on sensed acceleration caused by motion of the syringe assembly; and The one or more processing circuits are configured to determine, at least in part, when the syringe assembly has initiated a dispensing event based on the sensed acceleration.

7. The drug delivery system according to any one of claims 1-5, wherein, At least one of the one or more processing circuits is disposed within the device housing.

8. The drug delivery system according to any one of claims 1-5, wherein, At least one of the one or more processing circuits is disposed in a mobile device that is separate from the device housing and communicates wirelessly with a wireless transmitter disposed within the device housing.

9. The drug delivery system according to any one of claims 1-5, wherein, The one or more processing circuits are also configured to display or play instructions on how to use the drug delivery system in response to the first user instruction signal.

10. The drug delivery system according to any one of claims 1-5, wherein, The one or more processing circuits are configured to transmit a first user instruction signal to a remote device via a network.

11. The drug delivery system according to any one of claims 1-5, wherein, The one or more processing circuits are further configured to: The timing of the dispensing event of the syringe assembly is determined at least in part based on the sensor signals of the syringe assembly. Determine when the one or more skin contact sensors stop detecting contact with skin tissue; Measure a second duration between when the syringe assembly completes a dispensing event and when the one or more skin contact sensors stop detecting contact with skin tissue; Compare the second duration with the second pre-programmed threshold duration; as well as When the second duration is greater than the second pre-programmed threshold duration, a second user indication signal is generated.

12. The drug delivery system according to claim 11, wherein, The one or more processing circuits are also configured to display or play instructions on how to determine when the syringe assembly has completed dispensing in response to the second user indication signal.

13. The drug delivery system according to claim 11, wherein, The one or more processing circuits are configured to transmit the second user instruction signal to a remote device via a network.

14. The drug delivery system according to any one of claims 1-5, wherein, The cylinder holds the drug.

15. A method for generating instructions for a user of a drug delivery device, the device comprising: A device housing that defines an internal volume and an opening communicating with the internal volume; An injection cartridge assembly, at least partially disposed within the internal volume, includes a cartridge configured to hold a drug and an injection needle extending from the cartridge. A drive mechanism configured to initiate a dispensing event in which the syringe assembly dispenses medication from the injection needle when the injection needle extends at least partially out of the opening; One or more skin contact sensors are disposed on the housing adjacent to the opening, each skin contact sensor being configured to detect contact with skin tissue; And one or more syringe assembly sensors disposed within the device housing, configured to output syringe assembly sensor signals based on at least one of the position of at least a portion of the syringe assembly and the movement of at least a portion of the syringe assembly, the method comprising: Determine when the one or more skin contact sensors detect contact with skin tissue; The timing of the dispensing event of the syringe assembly is determined, at least in part, based on the sensor signals of the syringe assembly. Measure the first duration between when the at least one skin contact sensor detects contact with skin tissue and when the syringe assembly initiates a dispensing event; Compare the first duration with the first pre-programmed threshold duration; and When the first duration is greater than the first pre-programmed threshold duration, a first user indication signal is generated.

16. The method of claim 15, further comprising displaying or playing instructions on how to use the drug delivery device in response to the first user instruction signal.

17. The method according to any one of claims 15-16, further comprising transmitting a first user instruction signal to a remote device via a network.

18. The method according to any one of claims 15-16, further comprising: The timing of the dispensing event of the syringe assembly is determined at least in part based on the sensor signals of the syringe assembly. Determine when the one or more skin contact sensors stop detecting contact with skin tissue; Measure a second duration between when the syringe assembly completes a dispensing event and when the one or more skin contact sensors stop detecting contact with skin tissue; Compare the second duration with the second pre-programmed threshold duration; as well as A second user indication signal is generated when the second duration is greater than the second pre-programmed threshold duration.

19. The method of claim 18, further comprising displaying or playing an instruction on how to determine when the syringe assembly has completed dispensing in response to the second user indication signal.

20. The method of claim 18, further comprising transmitting the second user indication signal to a remote device via a network.

21. A non-transitory computer-readable medium storing instructions operable, when executed by at least one processing circuit, to cause the at least one processing circuit to perform the method according to any one of claims 15-20.

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