Drug delivery device with wake-up feature

Abstract

The technology described herein relates to computerized methods and devices for determining when a drug delivery device is ready for use. The method includes obtaining temperature data indicative of a temperature from a temperature sensor of the drug delivery device. The method includes obtaining, from an ambient light sensor, ambient light data indicative of an amount of ambient light to which at least a portion of the drug delivery device is exposed. The method includes determining whether the temperature exceeds a temperature threshold based on the temperature data. The method includes determining whether the amount of light exceeds an ambient light threshold based on ambient light data. The method includes outputting an indication that the drug delivery device has been ready for use when the temperature exceeds a temperature threshold and the amount of ambient light exceeds an ambient light threshold.

Description

Background Art

[0001] Many pharmaceutical products need to be stored at low temperatures. Patients are often instructed not to take or administer these products when they are in a cold state. Therefore, before taking or using, patients need to take the medications out of cold storage and allow them to warm up for a specified duration. Summary of the invention

[0002] According to an exemplary embodiment of the present disclosure, a computerized method is provided. The method includes obtaining temperature data indicating a temperature from a temperature sensor of a drug delivery device. The method includes obtaining ambient light data indicating an amount of ambient light to which at least a portion of the drug delivery device is exposed from an ambient light sensor. The drug delivery device includes a reservoir configured to contain a drug. The drug delivery device includes an actuation button for initiating injection of the drug. The method includes determining whether the temperature exceeds a temperature threshold based on the temperature data. The method includes determining whether the amount of light exceeds an ambient light threshold based on the ambient light data. The method includes outputting an indication that the drug delivery device is ready for use when the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold.

[0003] In some embodiments, the method includes determining whether the temperature increases over time based on the temperature data and previously obtained temperature data. In some embodiments, outputting the indication that the drug delivery device is ready for use includes outputting the indication after determining that the temperature increases over time.

[0004] In some embodiments, the drug delivery device comprises a visual indicator. In some embodiments, outputting the indication that the drug delivery device is ready for use comprises outputting the indication via the visual indicator.

[0005] In some embodiments, the visual indicator comprises at least one light emitting diode (LED).

[0006] In some embodiments, obtaining the temperature data and the ambient light data includes obtaining the temperature data and the ambient light data after a specified duration has elapsed since a start-up event.

[0007] In some embodiments, obtaining the temperature data and the ambient light data comprises receiving a wireless signal. In some embodiments, obtaining the temperature data and the ambient light data comprises obtaining the temperature data and the ambient light data after a specified duration has elapsed since receiving the wireless signal.

[0008] In some embodiments, the wireless signal comprises a Bluetooth Low Energy (BLE) signal.

[0009] In some embodiments, obtaining the temperature data includes obtaining data indicative of a temperature of a drug contained within the drug delivery device.

[0010] In some embodiments, the indication that the drug delivery device is ready for use is output after a period of time has elapsed after the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold, and after a period of time.

[0011] In some embodiments, a first preheat indication is provided when the temperature does not exceed the temperature threshold and / or the amount of ambient light does not exceed the ambient light threshold, a second preheat indication is provided during the timing of the elapsed period of time, or both. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Other embodiments of the present disclosure and their features and advantages will become more apparent by referring to the description herein in conjunction with the accompanying drawings. The components in the accompanying drawings are not necessarily drawn to scale. In addition, in the drawings, the same reference numerals represent corresponding parts in different views.

[0013] Figure 1 is a cross-sectional view of the injection device before use.

[0014] Figure 2 is a cross-sectional view of an injection device with the syringe assembly in a reservoir position and ready for an injection event.

[0015] Figure 3 is a cross-sectional view of the injection device with the syringe assembly in an injection position.

[0016] Figure 4 is a cross-sectional view of an injection device showing the placement of one or more main PCBs within the end of the injection device housing.

[0017] Figure 5A is a top (ie, far end) perspective view of the primary PCB and the secondary PCB.

[0018] Figure 5B is a bottom (ie, near-end) perspective view of the main PCB and the auxiliary PCB.

[0019] Fig. 6A It is a top view of the main PCB and auxiliary PCB.

[0020] Figure 6B Here is a bottom view of the main and auxiliary PCBs.

[0021] Figure 7 It is a system architecture diagram of the electrical components within the injection device and the electrical components of the external equipment.

[0022] Figure 8 is a block diagram depicting an example system 800 for determining when a drug delivery device is ready for use in accordance with some embodiments of the technology described herein.

[0023] Fig. 9 is a flow chart illustrating an exemplary computerized method 900 for determining when a drug delivery device is ready for use in accordance with some embodiments of the technology described herein.

[0024] Fig.10 is a flow chart illustrating an exemplary computerized method 1000 for determining when to begin obtaining temperature data and ambient light data in accordance with some embodiments of the technology described herein.

[0025] Fig.11 is a flow chart illustrating an exemplary computerized method 1100 for determining when to begin obtaining temperature data and ambient light data in accordance with some embodiments of the technology described herein.

[0026] Fig.12 is a block diagram illustrating an example system 1200 for determining when a drug delivery device is ready for use in accordance with some embodiments of the technology described herein.

[0027] Fig.13 is a diagram illustrating an example temperature sensing circuit 1302 in accordance with some embodiments of the techniques described herein.

[0028] Fig.14 An illustrative implementation of a computer system is shown that can be used to perform any aspect of the techniques and embodiments disclosed herein. DETAILED DESCRIPTION

[0029] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will be understood, however, that the invention is not thereby limited in its scope.

[0030] Provided herein is a technique for evaluating whether a drug and / or a drug delivery device is ready for use. According to some embodiments, the technique evaluates the readiness of a drug delivery device containing a drug based on available data, such as temperature data and ambient light data associated with the drug and / or the drug delivery device. For example, the drug delivery device may include one or more temperature sensors configured to sense the temperature of at least a portion of the drug delivery device, the temperature of the drug contained in the drug delivery device, and / or the ambient temperature to which the drug delivery device is exposed. Additionally or alternatively, the drug delivery device may include one or more ambient light sensors configured to sense the amount of light to which at least a portion of the drug delivery device and / or the drug is exposed. According to some embodiments, the technique determines whether the temperature exceeds a temperature threshold and whether the amount of ambient light exceeds an ambient light threshold based on the temperature data and the ambient light data. When the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold, in some embodiments, the technique outputs an indication that the drug delivery device is ready for use. For example, the drug delivery device may include a user feedback interface (e.g., a light emitting diode (LED), a display, a tactile indicator, and / or an audio indicator) that notifies the user that the drug delivery device is ready for use.

[0031] The inventor has realized that many drug products are stored at low temperatures (e.g., below ambient room temperature) and need to be preheated before use. Therefore, the patient needs to take the drug product out of a storage room (e.g., a refrigerator or a refrigerator) and wait for a period of time (e.g., 30 minutes) for the product to be preheated. However, the inventor has realized that the patient may not be able to track and / or may not remember the amount of time that the drug product has been taken out of the storage room. For example, although the patient can simply set a timer when taking out the drug product from the storage room, the patient may forget to do so. As another example, although the patient can try to remember the time passed with his brain, the patient may also forget to do so and / or not remember the time passed. Therefore, the patient may inject the drug prematurely when the drug is still in a low temperature state. Alternatively, the patient may be too cautious and leave the product for too long, thereby causing the drug to deteriorate, which may waste the patient's time and cause possible health consequences to the patient.

[0032] The inventors have recognized that many drug products, such as the drug delivery devices described herein, are provided to patients in a low power mode due to battery limitations. Such low power modes do not allow for a notification method that indicates that the product is ready for use. Furthermore, while a patient-facing button may be used to wake the product from a low power mode, providing such a button may be particularly costly from a manufacturing perspective, particularly if the product is intended for single use. Furthermore, providing such a button requires patient training and interaction, which may result in many of the same disadvantages described above. For example, the patient may forget to press the button.

[0033] The inventors have also recognized that a drug product may not be ready for use even if it is exposed to temperatures exceeding storage temperatures. For example, drug products can be exposed to warmer non-storage temperatures at the manufacturing plant, during transportation, at the pharmacy, and on the way to a patient's home. Therefore, whether a drug product is ready for use cannot be determined based solely on the product's temperature.

[0034] Therefore, the inventors have developed technology for evaluating and outputting an automatic indication of the readiness of a drug delivery device that addresses (e.g., mitigates or avoids) the above-mentioned limitations of conventional drug products. In some embodiments, the technology obtains temperature data from a temperature sensor and obtains light data from a light sensor (e.g., an ambient light sensor). After determining based on the obtained data that the sensed temperature and the sensed amount of light each exceed a corresponding threshold, the technology outputs an indication that the drug delivery device is ready for use.

[0035] In some embodiments, the processing circuitry of the drug delivery device may periodically perform the techniques described herein. The processing circuitry may be configured to remain in a low power mode and only wake up from the low power mode to periodically obtain temperature data and ambient light data, thereby preserving battery life. Additionally or alternatively, the processing circuitry may be configured to wake up from the low power mode upon determining that the drug delivery device is ready for use. Thus, the notification method may alert the user of readiness without relying on user intervention.

[0036] In some embodiments, by considering both the temperature and the amount of ambient light to which the drug delivery device is exposed, the technology can detect not only when the drug delivery device is removed from a cold storage chamber, but also when the drug delivery device is removed from its packaging (e.g., a box containing the drug delivery device). Thus, the technology can determine whether a temperature change is associated with an intended use of the drug delivery device by a patient based on whether the drug delivery device is also removed from its packaging. In some embodiments, when both conditions are met, it can indicate that the drug delivery device is ready for use. Such technology can also avoid indicating that the drug delivery device is ready for use when it is not intended to be used, such as when a user stores the drug delivery device in a refrigerator and is storing miscellaneous items (e.g., so that although the drug delivery device is exposed to light, the temperature does not rise enough to wake the drug delivery device).

[0037] Although various embodiments have been described, it will be apparent to those skilled in the art that there may be many more embodiments and implementations. Therefore, the embodiments described herein are examples, rather than the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that every embodiment will achieve all of the described advantages.

[0038] Figure 1-3 An exemplary drug delivery device or drug injection device 20 is shown in various operating states. Examples of such devices and their operation are described in U.S. Patent No. 8,734,394 B2, entitled “Automatic Injection Device with Delay Mechanism Including Dual Functioning Biasing Member,” filed by Adams et al. on May 27, 2014, and U.S. Patent No. 11,123,488 B2, entitled “Status Sensing Systems within an Injection Device Assembly,” filed by Adams et al. on September 21, 2021, the entire disclosures of which are incorporated herein by reference. The 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 auxiliary PCBs 84, such as those described later in Figure 4 . The syringe assembly 22 includes a barrel 30 forming a container body for containing a drug and a piston 32 disposed in 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 connector 35 for mounting the needle 34 to the syringe barrel 30. The piston 32 in the barrel 30 is pushed toward the needle 34 to administer the drug through the needle 34. Although the device 20 is described in detail herein as an automatic injector, other delivery devices with electronic devices may also be combined with one or more aspects described herein, such as injection pens, other types of automatic injectors, large-volume push syringes, and other types of disposable or reusable devices that are configured for variable and / or fixed dose therapy.

[0039] The devices described herein, such as device 20, may also include a drug, for example, in syringe barrel 30. In another embodiment, the system may include one or more devices, the one or more devices including device 20 and a drug. The term "drug" 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 peptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, including but not limited to IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, IL-2 antibody analogs or derivatives, therapeutic agents for pain-related treatment such as galcanzeumab or lasmiditan, and any therapeutic agent that can be delivered by the devices described herein. The drug used in the device can be formulated with one or more excipients. The device is typically operated by the patient, caregiver, or healthcare professional in the manner described above to deliver medication to a person.

[0040] Figure 1 The device 20 is shown in its initial pre-use configuration. Here, an end cap 36 is secured to an injection device housing 38 and covers a proximal opening 40 in the housing 38. As used herein, distal and proximal refer to axial positions relative to an injection site when the device is oriented for use at an injection site, whereby, for example, the proximal end of the housing refers to the end of the housing closest to the injection site and the distal end of the housing refers to the end of the housing farthest from the injection site. The housing 38 may be formed of a plastic material and is shown extending generally longitudinally along a longitudinal axis 48 between a distal end proximal to an actuation button 52 and a proximal end proximal to the proximal opening 40. As shown in FIG. Figure 2 and 4 As shown, the housing 38 may include a user-graspable portion 37 configured to be grasped by a user's hand, the user-graspable portion 37 extending radial distance 41 outward from the longitudinal axis 48. In some embodiments, the length of the radial distance 41 may be between 5-10 mm (e.g., in some embodiments, 5-8 mm may be a suitable length). Figure 2 and 4As shown, the housing 38 may also optionally include an outwardly flared end 39 located at the proximal end of the housing adjacent the proximal opening 40. The optional end extends outwardly from the longitudinal axis 48 by a radial distance 43 that is 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 10-20 mm (e.g., in some embodiments, 15-20 mm may be a suitable length). The end 39 may be smoothly radially outwardly inclined from the user-graspable portion 37, such as Figure 1-3 In other embodiments, the end 39 can take other forms of shape. For example, the end 39 can take any shape extending from the longitudinal axis 48 by a radial distance 43 that is greater than the radial distance 41 of the user-graspable portion.

[0041] Needle guard 42 is mounted on syringe assembly 22 and covers and surrounds needle 34. End cap 36 and needle guard 42 protect the user from accidental needle sticks and also protect needle 34 from damage. When using device 20 to administer medication, such as injecting medication into a patient, end cap 36 and needle guard 42 are first removed. Figure 2 The device 20 is shown after the end cap 36 and the needle guard 42 have been removed from the syringe assembly 22, wherein the syringe assembly is in a reservoir position and the device 20 is ready for a medication administration event.

[0042] The syringe assembly 22 is movable relative to the injection device 20 between a storage position and an injection position. Figure 3 The syringe assembly 22 is shown relative to the device 20. Figure 2 The device 20 is shown after the storage position has been moved to the injection position. Figure 1 and 2 ), the needle 34 is retracted to a position such that the needle 34 is disposed within the housing 38 of the device 20. In the injection position ( Figure 3 ), the needle 34 protrudes outward from the housing 38 in a proximal direction parallel to the longitudinal axis 48 beyond the proximal opening 40, whereby the needle 34 can be inserted into the patient's body.

[0043] The drive mechanism 24 includes a plunger 44 that engages the piston 32. The drive mechanism 24 includes a spring 46 that drives the plunger 44 in a translational 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 is further advanced, the syringe assembly 22 is advanced along the axis 48 from its reservoir position to its injection position. After the syringe assembly 22 is advanced to its injection position, the subsequent proximal advancement of the plunger 44 causes the piston 32 to move from its initial piston position (e.g., 1.5 mm) within the barrel 30. Figure 1 and 2) is advanced proximally to its final piston position (as shown Figure 3 34) to dispense medication from needle 34 during an administration event. Prior to any administration, and when syringe barrel 30 contains the entire original volume of medication, piston 32 will be in its initial piston position. After piston 32 is advanced toward needle assembly 33 over its entire stroke length range, piston 32 will be in its final piston position close to needle assembly 33, and medication from within barrel 30 will be expelled. In a single use, syringe assembly 22 contains a single dose of medication that will be delivered in a single injection event, and piston 32 will be advanced from its initial piston position to its final piston position in the single injection event, thereby delivering the entire single dose of medication from syringe assembly 22. Although the device is shown as a single-use device, device 20 may also be configured as a multiple-use device with appropriate modifications.

[0044] The advancement of plunger 44 does not usually result in the discharge of the drug from syringe assembly 22 until after syringe assembly 22 is advanced to the injection position. Before the syringe is advanced to the injection position, there are some factors that may inhibit the administration of the drug. One factor is the friction between piston 32 and barrel 30. Typically, piston 32 will be formed of a rubber material, and barrel 30 will be glass. The friction resistance between these two components is sufficient to prevent piston 32 from advancing in barrel 30 until syringe assembly 22 is advanced to its injection position, and the engagement with a suitable stop member prevents further advancement of syringe assembly 22. In addition, the drug in the syringe may be a little viscous, which may slightly hinder the flow from needle 34. When necessary, modifying piston 32 and syringe barrel 30 to change the friction resistance of engagement member 32 relative to the medication dispensing movement of syringe barrel 30 can limit or prevent premature medication before container 22 reaches its injection position.

[0045] To activate the drive mechanism 24, a person presses an actuation button 52 at the distal end of the device 20. Pressing the button 52 disengages one or both elongated prongs 54 on the plunger 44 from the shuttle assembly 60, thereby allowing the spring 46 to axially advance the plunger 44. The spring 46 has a helical shape and surrounds the prongs 54. The proximal end of the spring 46 engages a flange on the plunger 44 in a biasing manner.

[0046] The shuttle assembly 60 may include an upper shuttle member 62 and a lower shuttle member 64. In final assembly, the shuttle members 62, 64 are secured together. In final assembly, the upper shuttle member 62 captures the button 52 and the spring 46, thereby limiting axial movement of these components in the distal direction. Figure 1 and 2In the state shown, the fork 54 engages with the surface on the upper shuttle 62. Pressing the button 52 causes the protrusion on the button 52 to engage with the inclined surface on the fork 54 to bias the fork 54 inwardly, thereby disengaging the fork 54 from the upper shuttle member 62. After the fork 54 is disengaged, the spring 46 applies a biasing force on the flange to move the plunger 44 from Figure 2 The position shown is advanced to Figure 3 As plunger 44 is advanced, it moves syringe assembly 22 to the injection position and then advances piston 32 to administer the medication as described above.

[0047] After the administration event is complete, the retraction mechanism 26 optionally moves the syringe assembly 22 out of the Figure 3 The injection position shown moves back to the retracted position. More specifically, the retraction mechanism is suitable for moving the drug container from the injection position to the retracted position in a retraction motion. 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 completely 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 slightly closer to or farther away from the syringe assembly in the storage position. In the illustrated embodiment, the retraction mechanism includes a spring 66, a syringe carrier 68, and a rotating member 70 used as a follower. In other embodiments, the device 20 may not include the retraction mechanism 26, so that the syringe assembly remains in its injection position indefinitely after administration until the syringe assembly is manually removed or repositioned by the user.

[0048] The plunger 44 may include a sprag (not shown) that unlocks the rotating member 70 when the plunger 44 approaches the end of its stroke in the proximal direction. The rotating member 70 is rotationally fixed to the lower shuttle member 64 by engagement between the latch and the latch recess in the lower shuttle member 64. The sprag unlocks the member 70 by depressing the latch. The spring 66 is torsionally preloaded, one end of which engages with the member 70 and the other end of which engages with the shuttle assembly 60. When the latch is depressed, the spring 66 rotates the member 70.

[0049] The member 70 is rotatable within the housing 38 but cannot be axially moved relative to the housing 38. Other embodiments may include a member 70 that is also axially movable. The rotation of the member 70 serves as a delay mechanism to prevent the retraction mechanism 26 from retracting the syringe assembly 22 until the syringe assembly completes its drug dose delivery. The rotation speed of the member 70 can be adjusted by adjusting the viscosity of the grease disposed on or around the surface of the member 70 in contact with the housing 38 - a higher viscosity grease results in slower rotation, while a lower viscosity grease results in faster rotation. The radial flange on the rotating member 70 can engage with a crosspiece within the housing member 38 to limit the proximal movement of the member 70. The spring 66 can apply an axial force, a torsional force, or both forces on the member 70 to bias the member 70 toward the proximal end, thereby maintaining the member 70 in an axial position in which the radial flange of the member 70 engages with the internal crosspiece of the housing member 38.

[0050] The shuttle assembly 60 may include axially extending channels or ribs that engage corresponding features on the housing member 38 that allow the shuttle assembly 60 to move axially within the housing 38 but prevent relative rotation of the shuttle assembly 60 relative to the housing member 38. The shuttle assembly 60 is biased in the distal direction by the spring 66, but is prevented from moving distally by engagement of a latch (not shown) prior to activation of the drive mechanism 24. When the rotating member 70 completes its rotation, it disengages the latch, thereby allowing the shuttle assembly 60 to move distally under the biasing force of the spring 66.

[0051] As shuttle assembly 60 moves distally, it carries syringe assembly 22 distally and moves it back to Figure 2 The spring 66 biases the retraction mechanism 26 distally, thereby maintaining the syringe assembly 22 in its retracted position after an injection event. A locking mechanism, such as a detent on the shuttle assembly 60 and a recess on a member of the housing 38, can additionally provide a locking engagement to secure the syringe assembly 22 in the retracted position after an injection event with the needle 34 disposed within the housing 38 so that the user can place or otherwise handle the device 20 in a safe manner.

[0052] although Figure 1-3An exemplary drive mechanism 24 and an exemplary retraction mechanism 26 are shown and described, but other mechanisms may be used to drive the syringe assembly 22 from the storage position to the injection position, and / or from the injection position to the retraction position. Such a drive and / or retraction mechanism may (but not necessarily) include one or more springs or deformable components that store energy when maintained 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 retraction position. Such a mechanism may (but not necessarily) include a mechanism that generates power using a chemical reaction or process (e.g., by generating a gas from a mixture of two or more reagents, or by igniting a small amount of flammable or explosive material). Such a chemical drive mechanism may include one or more storage containers for chemical reagents; a trigger that pierces or opens the storage container, allows the reagents to mix, and / or provides a spark or other ignition source to start a chemical reaction; and a movable piston or other component that moves in response to an increase in gas pressure generated by the resulting chemical reaction. Such a mechanism may (but need not) include a motor that uses stored electricity (e.g., in a battery) to run a motor that drives and / or retracts the syringe assembly, or a mechanism that triggers other physical or chemical mechanisms. Such a mechanism may (but need not) include a hydraulic or pneumatic system (e.g., a tube), gears, cables, pulleys, or other known components for transferring kinetic energy from one component to another. In some embodiments, rather than having separate mechanisms for driving the syringe assembly and then retracting the syringe assembly, a single mechanism may be configured to drive and then retract the syringe assembly.

[0053] Figure 4 An exemplary placement of one or more main PCBs 82 within the end 39 is shown according to a first set of embodiments of the device 20. The one or more main PCBs can be arranged perpendicular to the longitudinal axis 48 and can be stacked on top of each other and / or can be arranged adjacent to each other in the same plane perpendicular to the longitudinal axis 48. The main PCB defines an opening 83 through which the injection needle 34 of the syringe assembly 22 is configured to pass, for example, when the end cap 36 is removed and the injection needle is driven proximally to inject a patient during an administration event. As shown, the main PCB extends a radial distance 45 away from the longitudinal axis 48, which is greater than the radial distance 41 of the user-graspable portion 37. Figure 4 Also shown are one or more auxiliary PCBs 84 extending substantially perpendicular to the primary PCB and parallel to the longitudinal axis 48, which auxiliary PCBs may be communicatively coupled to the primary PCB via one or more PCB connectors 114. While the auxiliary PCBs 84 may mount additional sensing systems, such auxiliary PCBs are optional and may be excluded in certain embodiments to reduce manufacturing complexity and cost.

[0054] Figure 5A shows a top perspective view of the main PCB and the auxiliary PCB, and Figure 5B A bottom perspective view of the same PCB is shown. Fig. 6A and 6B The top view and bottom view of the same PCB are shown respectively. Figure 4 ) may have a top surface 82a (as shown Figure 5A and 6A The main PCB 82 is shown in Figure 82 (top surface 82a is understood to be part of PCB 82), which includes or supports a power source 102, which in some embodiments can include a battery such as a button cell. The power source 102 provides power to electrical components integrated or coupled with the injection device 20. The main PCB 82 can also include a processing circuit 108. In some embodiments, the processing circuit 108 can take the form of a system-on-chip (SOC) integrated circuit, which includes a processor, a memory, and an input / output port. However, the processing circuit 108 can also be implemented using other types of components, such as a microcontroller (MCU) or an application-specific integrated circuit (ASIC). The processing circuit 108 can be configured to execute computer-executable instructions stored on a non-transitory storage medium. The main PCB can also include a plurality of 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 an auxiliary PCB, the auxiliary PCB may include other sensors, such as another micro switch sensor 116 , a magnetometer 118 , and an infrared temperature sensor 120 .

[0055] The micro switch sensors 110 and 116 can be communicatively coupled to the processing circuit 108. Each micro switch sensor can include a physical switch coupled to a circuit that outputs an electrical signal to the processing circuit 108 based on the physical position or orientation of the physical switch. The micro switch sensors 110 and 116 can be used to detect the position of the components of the injection device 20. For example, the micro switch sensor 110 can be used to detect whether the end cap 36 is attached to the proximal end of the device housing 38. As discussed in more detail below, based on the output of the micro switch sensor 110, the processing circuit 108 can indicate to the user whether the end cap 36 is attached to the device 20. Similarly, the micro switch sensor 116 can be used to detect whether the syringe assembly 22 is in one of the following two states: such as (i) a reservoir position or (ii) an injection position. The micro switch sensor 116 can also be configured to detect whether the syringe assembly 22 is in one of the following three states: such as (i) a reservoir position, (ii) an injection position, or (iii) a retracted position. Based on the output of micro switch sensor 116, processing circuit 108 can indicate to the user what position syringe assembly 22 is in.

[0056] The ambient light sensor 106 may be communicatively coupled to the processing circuit 108 and may detect the amount or intensity of ambient light to which the injection device 20 is exposed. Excessive exposure to ambient light may render the injection of the medication stored in the cartridge 30 ineffective or unsafe. In some embodiments, the processing circuit 108 may record the intensity and / or duration of ambient light detected by the ambient light sensor 106. If the intensity and / or duration of exposure to ambient light exceeds a predetermined threshold, the user may be notified that the medication should not be used.

[0057] The accelerometer 140 may be communicatively coupled to the processing circuit 108 and may determine the orientation (e.g., pointing up, pointing down, or pointing to the side) of the injection device 20. This may be important for certain types of medications, which may be significantly affected by gravity due to settling of particulate matter, etc., which would require the medication to be delivered in a specific orientation. The processing circuit 108 may also use the output of the accelerometer 140 to warn the user if the orientation of the device 20 is not appropriate for injection (e.g., if the device is upside down).

[0058] Many types of medications need to be stored at a first, relatively low temperature (e.g., between 36 and 46 degrees Fahrenheit, or between 2 and 8 degrees Celsius) to prevent spoilage, but need to be heated to a second, higher temperature (e.g., heated to room temperature, or 65 to 75 degrees Fahrenheit, or 18 to 24 degrees Celsius) before being injected into the patient. In order to ensure that the medication within the barrel 30 is stored at an appropriate 40 storage temperature, and / or to ensure that the medication is heated to an appropriate injection temperature, the injection device 20 can be equipped with a mechanism for estimating the temperature of the medication. By ensuring that the medication has been heated to the appropriate temperature, 45 this information can be transmitted to a cell phone, or the device itself can signal the patient that the device is ready for use. In some embodiments, this temperature measurement function can be performed by an infrared (IR) temperature sensor 120 on the auxiliary PCB 84. The IR sensor 120 can be communicatively coupled 50 to the processing circuit 108. As Figure 4 As best seen in FIG. 1 , the IR sensor 120 can be disposed proximate to and facing the barrel 30. The IR sensor 120 can detect and measure electromagnetic radiation in the IR spectrum from the barrel 30 and output 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 within the barrel 30.

[0059] The main PCB may also be equipped with one or more antennas for sending or receiving wireless communications. Figure 5A and 5BA Bluetooth Low Energy (BLE) antenna 104 is shown disposed on the upper surface 82a of the main PCB, and a Near Field Communication (NFC) antenna 126 (shown as a thick black lining element) is disposed on the bottom surface 82b of the main PCB. Other embodiments are 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 can allow the injection device 20 to establish a wireless communication link with an external device.

[0060] The main PCB may also be communicatively coupled or integrated with a plurality of sensors that detect contact with skin tissue. The skin contact sensors may be used to verify proper contact with the user's skin before the user activates the injection device 20. The injection device 20 may also indicate to the user which sensors detected skin contact and which did not; this lets the user know in which way he or she should tilt or move the injection device 20 before an injection. This functionality reduces the likelihood of a failed injection (where the needle 34 fails to penetrate the user's skin, or penetrates at an inappropriately shallow angle).

[0061] Figure 5B and 6B An exemplary embodiment including three skin contact sensors 122, 123 and 124 is shown, which are arranged on the bottom surface 82b of the main PCB and arranged in a symmetrical trilobate shape. In this exemplary embodiment, each skin contact sensor 122, 123 and 124 includes two separate 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 of each sensor are shown, other embodiments in which each sensor has more than two electrical terminals are also possible. Each skin contact sensor can measure the resistance between its electrical terminals and output an electrical signal to the processing circuit 108 based on the measured resistance. The resistance of skin tissue is generally lower than the resistance of air, so when the measured resistance is lower than a predetermined threshold, the processing circuit 108 can determine that a specific skin contact sensor is in contact with skin tissue.

[0062] although Figure 5B and 6BEach skin contact sensor 122, 123 and 124 is shown as having two electrical terminals, but other embodiments in which each skin contact sensor has only one electrical terminal are also possible. In this case, the electrical terminal of one skin contact sensor (e.g., sensor 122) can be used as a reference electrode that outputs a predetermined voltage. The electrical terminal on each of the other two skin contact sensors (e.g., sensors 123 and 124) can be used as a sensor electrode that measures the resistance of the conductive path between itself and the reference electrode. When the measured resistance between the reference electrode and the specific sensor electrode is lower than a predetermined threshold, the processing circuit 108 can determine that the reference electrode and the specific sensor electrode are both in contact with human tissue (such as skin). When the measured resistance reported by two sensor electrodes (e.g., on sensors 123 and 124) is lower than a predetermined threshold, the processing circuit 108 can determine that the reference electrode and the two sensor electrodes are both in contact with human tissue.

[0063] like Figure 6B As best shown, each skin contact sensor 122, 123 and 124 can be located at a position from the longitudinal axis 48 (at Fig.10 B, the longitudinal axis 48 extends into the page) outward at radial distances 128, 130 and 132. Sensors 122, 123 and 124 can optionally be arranged symmetrically around opening 83 so that radial distances 128, 130 and 132 are equal to each other and the angular separation between each sensor is also equal (e.g., 120° in this case). Radial distances 128, 130 and 132 are greater than radial distance 41 of user-graspable portion 37 (e.g., 120° in this case). Figure 2 and 9 83) and may be greater than 10 mm in length. For example, in some embodiments, radial distances 128, 130, and 132 may each be between 10 mm and 20 mm in length - in some cases, distances of 15 mm to 20 mm are suitable. Although three skin sensors are shown, other embodiments having only one or two skin sensors are possible. Conversely, embodiments having more than three skin contact sensors are possible - in these embodiments, the skin sensors may (but are not necessarily) symmetrically arranged around opening 83. For example, other embodiments including four to twenty skin sensors are also contemplated.

[0064] Although skin contact sensors 122, 123, and 124 are described above as measuring resistance, these skin contact sensors may alternatively be configured to detect skin contact by measuring capacitance. Capacitive sensors may be configured to detect the proximity of human tissue by detecting the effect of human tissue on the electric field generated by the sensor (e.g., by detecting the effect of such tissue on the capacitance of a circuit monitored or measured by the sensor). Capacitive sensors do not require metal electrical terminals that directly contact skin tissue and, therefore, may be partially or completely sealed behind a protective non-conductive cover (e.g., made of plastic). This may improve the durability of the capacitive sensor by reducing the penetration of moisture or foreign matter into sensitive electrical components. Capacitive sensors may also reduce the risk of electrostatic discharge damaging sensitive electrical components within a device because capacitive sensors do not require exposed metal contacts.

[0065] 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 circuit 108 to estimate the amount of drug remaining in the barrel 30 and / or the amount of drug that has been administered (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 one or more magnetometers that sense the magnetic field emitted by the magnet as the piston 32 slides along the longitudinal axis. Figure 1-3 An exemplary magnet 25 is shown disposed on the plunger 44 such that it maintains a fixed axial distance from the piston 32 as the piston slides along the longitudinal axis 48 within the barrel 30 . Figure 5A , 5B , 6A and 6B also show an exemplary placement of two magnetometers: magnetometer 112 on the main PCB 82 and magnetometer 118 on the auxiliary PCB 84. As shown, magnetometer 112 can be radially disposed farther from the longitudinal axis 48 than magnetometer 118. In addition, magnetometer 118 can be disposed at an intermediate point along the length of barrel 30, rather than being positioned near one end of barrel 30.

[0066] Figure 7A system architecture view of the electrical components within the apparatus 20 and a communication link with an exemplary external device 750 is provided. As described above, the processing circuit 108 can be powered by the battery 102 and can include a processing core 708 and a memory 710 (e.g., internal flash memory, on-board electrically erasable programmable read-only memory (EPROM), etc.). The memory 710 can store instructions that, when executed by the processing core 708, cause the processing circuit 108 to perform the operations described herein. The processing circuit 108 can also be communicatively coupled to a plurality of sensors, such as an ambient light sensor 106, an end cap microswitch 110, a magnetometer 112, an accelerometer 140, and skin contact sensors 122, 123, and 124. The processing circuit 108 can also be communicatively coupled to one or more auxiliary PCBs, optionally via a flexible connector 114. The auxiliary PCB can also include a microswitch 116, a magnetometer 118, and an IR temperature sensor 120. The processing circuit 108 can also be connected to a device 708 for user feedback integrated with the apparatus 20. Means for user feedback may include one or more indicator lights (e.g., implemented using light emitting diodes (LEDs)), displays, tactile indicators such as vibration motors, and / or audible indicators such as speakers. Processing circuitry 108 may be communicatively coupled to each of the above components via one or more physical, electrical channels, such as (but not limited to) general purpose input / output (GPIO) pins, an inter-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, the signals received by 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).

[0067] The processing circuit 108 may also be configured to allow the injection device 20 to communicate wirelessly with an external device such as, for example, a mobile phone, a wearable device, a laptop computer, and / or a server database. To facilitate wireless communication, the processing circuit 108 may include a NFC antenna 705 such as, Figure 5B and 6B 126) is communicatively coupled to a near field communication (NFC) circuit 1204. The NFC circuit 704 and the NFC antenna 705 allow the processing circuit 108 to establish a wireless NFC communication link 732 with the external device 750. Alternatively or additionally, the processing circuit 108 may include a BLE antenna 707 (such as, Figure 5A and 6A The processing circuit 108 is shown as a BLE antenna 104 that is communicatively coupled to a Bluetooth Low Energy (BLE) circuit 706. The BLE circuit 706 and the BLE antenna 707 allow the processing circuit 108 to establish a wireless BLE communication link 734 with an external device 750.

[0068] Figure 7 Also shown is an exemplary external device 750 that is physically separate from the injection device 20. In this embodiment, the exemplary external device 750 can take the form of a mobile smartphone having a processor 752 (e.g., a microprocessor or CPU) and a storage device 758. The storage device 758 can include a non-transitory computer-readable medium storing computer-executable instructions that, when executed by the processor 752, cause the device 750 to perform the operations described herein. These computer-executable instructions can include a mobile application, such as a medical mobile application. The device 750 can also include a display 760 and a user input device 762. The user input device 762 can include a physical button or switch integrated with the smartphone. Although in Figure 7 760, but all or part of the user input device 762 may be integrated with the display 760, for example in a touch-sensitive screen. The device 750 may also include a vibration source 764, such as a vibration motor.

[0069] The device 750 may be configured to establish a wireless communication link with the injection device 20. For example, the external device 750 may include an NFC circuit 754 coupled to an NFC antenna 755, which communicates with the processing circuit 108 via the communication link 732. The device 750 may also include a BLE circuit 756 coupled to a BLE antenna 707, which communicates with the processing circuit 108 via the communication link 734.

[0070] Figure 8 8 is a block diagram illustrating an exemplary system 800 for determining when a drug delivery device is ready for use according to some embodiments of the technology described herein. System 800 includes a drug delivery device 820 that is optionally configured to communicate with an external device 850 via a network 830 .

[0071] In some embodiments, the drug delivery device 820 includes a processing circuit 812 that is communicatively coupled to the temperature sensor 802, the ambient light sensor 806, the user feedback interface 808, and the memory 810. A timer 815 is also shown as part of the device. The timer can be a clock, a real-time timer clock, a software clock, a counter, etc. The drug delivery device 820 can include any suitable drug delivery device, such as, for example, the drug delivery device 20 described herein, including at least about Figure 1-7 The drug delivery device.

[0072] In some embodiments, the processing circuit 812 is configured to obtain temperature data from the temperature sensor 802 and / or obtain ambient light data from the ambient light sensor 806. The processing circuit 812 processes the temperature data and / or the ambient light data to determine a state of the drug delivery device 820. For example, the processing circuit 812 may process the temperature data and / or the ambient light data to determine whether the drug delivery device 820 is ready for use (e.g., to administer / take medication).

[0073] In some embodiments, the temperature sensor 802 includes one or more temperature sensors, each of which is configured to sense a temperature. The sensed temperature can be the temperature of the drug delivery device 820, the temperature of the drug contained within the drug delivery device 820, and / or the temperature of the environment to which at least a portion of the drug delivery device 820 is exposed. The temperature sensor 802 can take the form of any suitable sensor for sensing temperature, such as, but not limited to, a thermistor (e.g., a negative temperature coefficient (NTC) thermistor or a resistance temperature detector (RTD)), a thermocouple, an infrared (IR) temperature sensor, or a semiconductor-based temperature sensor. For example, the temperature sensor 802 can include the ambient temperature sensor 135 and / or the IR temperature sensor 102 described herein, including at least a reference Figure 5A-7 The temperature sensor.

[0074] In some embodiments, the processing circuit 812 is configured to estimate the state of the drug delivery device 820 based on the temperature data obtained from the temperature sensor 802 and / or the memory 810. For example, the processing circuit 812 can be configured to determine whether the temperature associated with the drug delivery device 820 exceeds a temperature threshold based on the temperature data. Additionally or alternatively, the processing circuit 812 can be configured to determine whether the temperature associated with the drug delivery device 820 has increased over a period of time. In some embodiments, the temperature associated with the drug delivery device 820 includes the temperature of the drug contained within the drug delivery device 820, the ambient temperature to which the drug delivery device 820 is exposed, and / or the temperature of the drug delivery device 820 itself.

[0075] In some embodiments, ambient light sensor 806 includes one or more light sensors configured to sense the amount of light to which at least a portion of drug delivery device 820 is exposed. Ambient light sensor 806 can take the form of any suitable sensor for sensing light, such as, but not limited to, a sensor utilizing one or more photodiodes, photoresistors, and / or phototransistors. For example, ambient light sensor 806 can include ambient light sensor 106 as described herein, including at least one embodiment of the present invention. Figure 5A-7 The ambient light sensor 106 .

[0076] In some embodiments, processing circuit 812 is configured to estimate a state of drug delivery device 820 based on ambient light data obtained from ambient light sensor 806 and / or memory 810. For example, processing circuit 812 can be configured to determine whether an amount of ambient light exceeds an ambient light threshold based on the ambient light data. In some embodiments, ambient light includes ambient light to which at least a portion of drug delivery device 820 has been exposed.

[0077] In some embodiments, the processing circuit 812 is configured to estimate the state of the drug delivery device 820 based on a combination of the ambient light data and the temperature data. For example, the processing circuit 812 can be configured to determine whether the amount of ambient light exceeds an ambient light threshold, whether the temperature exceeds a temperature threshold, and / or whether the temperature increases over a period of time based on the ambient light data and the temperature data. Techniques for estimating the state of a drug delivery device are described herein, including at least Fig. 9 The technology described.

[0078] According to some embodiments, the processing circuit 812 may take the form of a processor (e.g., a microprocessor or microcontroller, a field programmable gate array (FPGA), and / or a digital signal processor (DSP, or any combination of the foregoing)) that is configured to execute logic stored in a memory to perform the operations described herein. The terms "logic," "control logic," "instructions," or "applications" as used herein may include software and / or firmware executed on any of the foregoing processing circuits. Other examples of processors are described herein, including at least with respect to Figure 7 and 14 The example described.

[0079] In some embodiments, the processing circuit 812 is configured to communicate with the user feedback interface 808 and cause the user feedback interface 808 to output feedback (e.g., to a user). The user feedback interface 808 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 audible indicator (such as a speaker). In some embodiments, the processing circuit 812 may cause the user feedback interface 808 to output feedback based on the state of the drug delivery device 820. For example, the processing circuit 812 may cause the user feedback interface 808 to illuminate an LED, display text and / or graphics, vibrate, and / or output a sound in response to receiving an indication from the processing circuit 812 that the drug delivery device 820 is ready for use.

[0080] In some embodiments, the processing circuit 812 is configured to transmit temperature data, ambient light data, and / or data indicative of the status of the drug delivery device 820 to the memory. The memory 810 can be any suitable computer-readable medium accessible to the processing circuit, and includes both volatile and non-volatile memory. Exemplary memories include random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, magnetic storage devices, optical disk storage devices, or any other suitable medium configured to store data and accessible directly or indirectly by the processor circuit via one or more intermediate devices or wired or wireless communication links. Although the foregoing description assumes that the memory 810 is separate from the processing circuit but communicatively coupled, in some embodiments, the memory 810 may also be integrated with the processing circuit 812. In some embodiments, instead of a processor executing logic stored in the memory 810, the processing circuit 812 may take the form of hard-wired logic, such as a state machine and / or an application-specific integrated circuit (ASIC) that performs the functions described herein. Other examples of memory are described herein, including at least with respect to Figure 7 and 14 The example described.

[0081] In some embodiments, drug delivery device 820 (eg, processing circuit 812) is configured to communicate with one or more external devices 850 via network 830. Example external devices include mobile device 850a, Bluetooth beacon 850b, and second drug delivery device 850c.

[0082] The mobile device 850a may include any device that receives, stores, and / or processes data from the drug delivery device 820 via wireless signals received by the communication circuitry of the mobile device 850a. Exemplary mobile devices include smartphones, smart watches, tablet computers, and / or laptop computers. The wireless signal may be an active signal, where the mobile device 850a receives a signal sent by the communication circuitry (not shown) of the drug delivery device 820, or it may be a passive signal, where the mobile device 850a senses modulation of a signal sent by the drug delivery device 820. The mobile device 850a may include separate communication circuitry configured to communicate with other devices (e.g., using a long-range or cellular transmission protocol).

[0083] In some embodiments, the drug delivery device 820 is configured to send information indicating the status of the drug delivery device 820 to the mobile device 850a. For example, such information may indicate that the drug delivery device 820 is ready for use. In some embodiments, the mobile device 850a is configured to display information indicating the status of the drug delivery device 820 on a user interface. For example, a display on the user interface of the mobile device 850a may notify the user that the drug delivery device 820 is ready for use. Additionally or alternatively, the user interface of the mobile device may be configured to display additional information about the drug delivery device 820, such as information about the drug contained within the drug delivery device 820, information about the patient's dosing regimen, and / or any other suitable information, as aspects of the technology described herein are not limited in this regard.

[0084] In some embodiments, the Bluetooth beacon 850b includes a hardware transmitter configured to broadcast a Bluetooth signal (e.g., a Bluetooth low energy (BLE) signal) to nearby devices (e.g., a drug delivery device, a mobile device, etc.). In particular, the Bluetooth beacon 850b can send an information packet including a unique identifier (e.g., a universally unique identifier (UUID)) that is configured to cause an event at a receiving device. For example, the drug delivery device 820 can be configured to receive a signal from the Bluetooth beacon 850b, which can cause a start event at the processing circuit 812 of the drug delivery device 820. For example, the signal can cause the processing circuit 812 to enter a low power mode.

[0085] In some embodiments, drug delivery device 850c is a second drug delivery device separate from drug delivery device 820. For example, drug delivery device 850c and drug delivery device 820 can be stored together (e.g., in the same refrigerator or freezer). In some embodiments, drug delivery device 850c and drug delivery device 820 can contain doses of a drug to be used together. In some embodiments, drug delivery device 850c and drug delivery device 820 can contain doses of a drug to be used at different times.

[0086] In some embodiments, the drug delivery device 820 and the drug delivery device 850c are configured to communicate with each other via the network 830. For example, the drug delivery device 850c may include a communication circuit capable of wirelessly communicating with the drug delivery device 820. In some embodiments, the drug delivery device 850c may send information indicating its status to the drug delivery device 820. For example, the drug delivery device 850c may send information indicating that it is or was previously ready for use. The drug delivery device 820 may store the information received from the drug delivery device 850c in the memory 810 and / or send the information to another external device, such as the mobile device 850a.

[0087] Network 830 may be or include a wide area network (eg, the Internet), a local area network (eg, a corporate Internet), and / or any other suitable type of network. Figure 8 Any of the devices shown may be connected to the network 830 using one or more wired links, one or more wireless links, and / or any suitable combination thereof. Thus, the network 830 may be, for example, a hardwired network (e.g., a local area network within a medical facility), a wireless network (e.g., connected via Wi-Fi and / or a cellular network), a cloud-based computing network, or any combination thereof.

[0088] Fig. 9 820) is a flow chart illustrating an exemplary method 900 for determining when a drug delivery device (e.g., drug delivery device 820) is ready for use according to some embodiments of the technology described herein. Method 900 can be implemented on a drug delivery device (such as drug delivery device 820) and can be a computerized method or implemented in a simulation.

[0089] In some embodiments, method 900 includes a subprocess 902 for evaluating the amount of light to which the drug delivery device is exposed, a subprocess 904 for evaluating the temperature to which the drug delivery device is exposed, and a subprocess 906 for evaluating the temperature trend to which the drug delivery device has been exposed. In some embodiments, one or more of subprocesses 902, 904, and 906 may be optional. For example, subprocess 906 may be optional. Subprocesses 902, 904, and / or 906 may be performed in parallel or in any suitable order.

[0090] Subprocess 902 includes steps 902a and 902b. In step 902a, a processing circuit (e.g., processing circuit 812) obtains ambient light data from an ambient light sensor (e.g., ambient light sensor 806) of a drug delivery device. The ambient light data may indicate an amount of light to which a portion (e.g., some, most, or all) of the drug delivery device is exposed. For example, the ambient light data may indicate an amount of light to which an exterior portion (e.g., a portion of a housing) of the drug delivery device is exposed.

[0091] In step 902b, the processing circuit determines whether the amount of ambient light exceeds an ambient light threshold based on the ambient light data. When the amount of ambient light exceeds the ambient light threshold, this may indicate that the drug delivery device has been exposed to a new environment. For example, this may indicate that the drug delivery device has been removed from a storage container (e.g., packaging, a refrigerator, etc.) and is now exposed to more light. Therefore, in some embodiments, the ambient light threshold is configured to specify a transition between the amount of light in a storage environment and the amount of light in a non-storage environment. For example, the ambient light threshold can be a value in the range of 0 lux to 50 lux, and in one example, the ambient light threshold is 10 lux. However, it should be understood that the ambient light threshold may depend on the packaging and / or expected storage conditions of the drug delivery device.

[0092] Subprocess 904 includes steps 904a and 904b. In step 904a, the processing circuit obtains temperature data from a temperature sensor of the drug delivery device (e.g., temperature sensor 802). The temperature data may indicate the temperature of the environment to which at least a portion of the drug delivery device is exposed, the temperature of the drug contained in the drug delivery device, and / or the temperature of the drug delivery device itself.

[0093] At step 904b, the processing circuit determines whether the temperature exceeds a temperature threshold based on the temperature data. In some embodiments, the drug contained in the drug delivery device needs to be stored at or below a specific temperature. When the temperature exceeds the temperature threshold, this may indicate that the drug delivery device has been exposed to a temperature higher than a specified storage temperature. Therefore, in some embodiments, the temperature threshold is configured to specify a transition between a storage temperature and a non-storage temperature. As a non-limiting example, the temperature threshold may be a value in the range of 0°C to 40°C, and in one example, the temperature threshold is 10°C. However, it should be understood that the temperature threshold may depend on the specified storage temperature of the drug contained in the drug delivery device.

[0094] Subprocess 906 includes steps 906a and 906b. In step 906a, the processing circuit can obtain previously obtained temperature data. For example, the processing circuit can obtain previously obtained temperature data from a memory on the drug delivery device (e.g., memory 810). In some embodiments, the previously obtained temperature data can indicate the temperature sensed by the temperature sensor at one or more previous times (e.g., before performing method 900). In some embodiments, the processing circuit can also obtain the output of step 904a, which can include the most recently obtained temperature data (e.g., obtained when performing method 900).

[0095] At step 906b, the processing circuit may determine whether the temperature has increased over time based on the previously obtained temperature data and the temperature data obtained at step 904a. Assessing whether the temperature has increased over time may help determine whether the temperature change is only temporary. For example, when a drug delivery device is transported between a pharmacy refrigerator and a patient's home refrigerator, the drug delivery device may experience a temporary temperature change (e.g., the temperature increases for a period of time and then decreases). In contrast, when a drug delivery device is removed from a refrigerator and thawed, the drug delivery device may experience a permanent temperature change (e.g., the temperature only increases for a period of time).

[0096] At step 908, method 900 includes outputting an indication that the drug delivery device is ready for use when the amount of ambient light exceeds an ambient light threshold, the temperature exceeds a temperature threshold, and (optionally) when the temperature increases over time. In some embodiments, the processing circuit can communicate with a user feedback interface (e.g., user feedback interface 808) and / or an external device (e.g., mobile device 850a) to prompt the user feedback interface and / or external device to output an indication that the drug delivery device is ready for use. For example, the user feedback interface can illuminate an LED, display text and / or graphics, vibrate, and / or output a sound in response to receiving an indication that the drug delivery device is ready for use. Additionally or alternatively, the external device can display text and / or graphics on the user interface, output a sound, and / or vibrate in response to receiving an indication that the drug delivery device is ready for use.

[0097] According to some embodiments, at step 908, if the drug delivery device is not ready for use, method 900 may return to subprocesses 902, 904, and 906. For example, if the ambient light does not exceed an ambient light threshold, the temperature does not exceed a temperature threshold, or the temperature does not increase over time, the drug delivery device may not be ready for use.

[0098] According to some embodiments, at step 908, the drug delivery device may not be ready for use, and method 900 may delay outputting an indication for a period of time after the amount of ambient light exceeds an ambient light threshold and the temperature exceeds a temperature threshold, and (optionally) when the temperature increases over time. For example, when the manufacturer determines that the drug temperature is lower than the device temperature or the ambient temperature, the drug delivery device may not be ready for use even if the ambient light exceeds the ambient light threshold, the temperature exceeds the temperature threshold, or the temperature increases over time. It is determined that a further delay before outputting an indication can allow the drug temperature to increase to an acceptable level. The method can continue to determine whether the ambient light exceeds the ambient light threshold, whether the temperature exceeds the temperature threshold, or whether the temperature increases at any time. The amount of the time delay can be based on many factors, such as, for example, drug formulation characteristics, device structure, container structure, etc. In one example, it can be determined that a fifteen minute delay is sufficient time for the drug temperature to reach an acceptable injection level after other conditions are met. In this case, once the conditions of subprocesses 902, 904, and 906 are met, the timer (see Figure 8 The timer 815 in the example of FIG. 810 may be started for a determined or predetermined amount of time, and after the countdown timer has elapsed, the method of outputting the indication may occur. Initially providing during the phases of running the subprocesses 902, 904, and 906, user feedback of a preheat indication of a first state, e.g., a first pattern of LED colors and / or sounds, sequences, and frequencies, or nothing, providing user feedback of another preheat indication of a second state different from the first state, e.g., a second pattern of LED colors and / or sounds, sequences, and frequencies, or both preheat indications may be provided.

[0099] In some embodiments, step 908 may check for one or more additional drug delivery devices. For example, as described herein, a patient's dosing regimen may require the use of multiple drug delivery devices for a single drug administration. Thus, the drug delivery device may check (e.g., via a wireless signal) whether one or more additional drug delivery devices are also within range and activated and / or being activated. If a second drug delivery device is not detected, step 908 may not indicate that the drug delivery device is available for use and / or may provide a related notification to indicate that a second partner drug delivery device was not detected within range.

[0100] As described above, the processing circuitry of the drug delivery device can be configured to periodically execute method 900 to determine whether the drug delivery device is ready for use. In some embodiments, to initiate periodic execution of method 900, the processing circuitry is initiated during a manufacturing step. For example, the processing circuitry can be initiated at some point before the drug delivery device is packaged. However, after such a manufacturing step, the drug delivery device may remain in the manufacturing plant for a period of time (e.g., one or several hours, days, or weeks). While at the manufacturing plant, the drug delivery device may be packaged, repackaged, transferred to a vehicle, and otherwise handled. During this period, the drug delivery device may be exposed to conditions that meet the reference Fig. 9 Therefore, the drug delivery device may be incorrectly awakened from the low power mode before being shipped to the pharmacy or patient.

[0101] Thus, in some embodiments, techniques are employed to delay execution of the method 900 for determining whether a drug delivery device is ready for use. Fig.10 is a flow chart illustrating an exemplary method 1000 for determining a timing for obtaining temperature data and ambient light data (eg, beginning execution of method 900 ) in accordance with some embodiments of the techniques described herein.

[0102] At step 1002, the processing circuitry of the drug delivery device is activated. For example, as described above, the drug delivery device may be activated during a manufacturing step of the drug delivery device.

[0103] However, at step 1004, the processing circuitry is configured to allow a specified duration to elapse rather than immediately executing method 900 (e.g., obtaining and processing temperature data and ambient light data). For example, the processing circuitry may be configured to allow sufficient time to elapse such that the drug delivery device is no longer at the manufacturing facility when method 1000 proceeds to act 1006. For example, the processing circuitry may be configured to allow one or more hours, a day or days, and / or a week or weeks to elapse before method 1000 proceeds to step 1006.

[0104] At step 1006, after the designated duration has elapsed, the processing circuitry of the drug delivery device begins acquiring temperature data and / or ambient light data (eg, begins executing method 900).

[0105] In some embodiments, additional or alternative techniques may be employed to delay execution of method 900 . Fig.11 is a flow chart illustrating an exemplary method 1100 (computerized or simulated) for determining timing for obtaining temperature data and ambient light data in accordance with some embodiments of the techniques described herein.

[0106] At step 1102, the processing circuitry of the drug delivery device is activated. For example, as described above, the drug delivery device may be activated during a manufacturing step of the drug delivery device.

[0107] After booting up, in some embodiments, the processing circuit is configured to enter a sleep state at step 1104. For example, in the sleep state, the processing circuit does not perform steps of method 900, such as obtaining temperature data and ambient light data.

[0108] At step 1106, after a specified duration, the processing circuit is configured to cause a start event, such as waking the circuit from a sleep state. For example, the processing circuit may be configured to be awakened from a sleep state after one or several hours, a day or several days, or a week or several weeks.

[0109] In some embodiments, after the processing circuit is awakened from the sleep state at step 1106, the processing circuit can be configured to listen for wireless signals. In some embodiments, the wireless signals can include any suitable wireless signals, such as, for example, wireless signals from a Bluetooth beacon (e.g., Bluetooth beacon 850b) located in a manufacturing plant.

[0110] If the processing circuit receives a wireless signal at step 1108, the method 1110 returns to step 1104 and the processing circuit re-enters the sleep state. For example, the processing circuit may cause another start event, such as re-entering the sleep state within the same specified duration as described above with respect to action 1106. Alternatively, the processing circuit may re-enter the sleep state within a different specified duration (e.g., one or several hours, days, or weeks).

[0111] If the processing circuit does not receive a wireless signal at step 1108, then method 1100 proceeds to act 1110. At act 1110, in some embodiments, the processing circuit begins obtaining temperature data and / or ambient light data (eg, begins executing method 900).

[0112] In some embodiments, additional or alternative techniques are provided for assessing when a drug delivery device is ready for use. The techniques described herein include at least Fig.12 and 13 The described techniques rely on ultra-low power analog circuitry to assess when a drug delivery device is ready for use. In some embodiments, the output signal of such circuitry is provided as an input to a processing circuit of a drug delivery device, as described herein. In some embodiments, the signal can cause the processing circuitry to wake up from a low power mode and allow the drug delivery device to output an indication that it is ready for use.

[0113] Fig.128 is a block diagram illustrating an exemplary system 1200 for determining when a drug delivery device is ready for use according to some embodiments of the technology described herein. As with system 800, system 1200 includes a drug delivery device 820 that includes at least a processing circuit 812 and a user feedback interface 808. In some embodiments, drug delivery device 820 is also optionally coupled to an external device 850 via a network 830.

[0114] Unlike System 800, Fig.12 In the illustrated embodiment, the drug delivery device 820 includes a temperature sensing circuit 1202. In some embodiments, the temperature sensing circuit 1202 is configured to sense a temperature associated with the drug delivery device 820. For example, the sensed temperature may include the temperature of the drug delivery device 820 and / or the temperature of the environment to which at least a portion of the drug delivery device 820 is exposed. For example, the temperature sensing circuit may include the example temperature sensing circuits described herein, including at least about Fig.13 An example temperature sensing circuit is described.

[0115] In some embodiments, the temperature sensing circuit 1202 is configured to generate an output signal (eg, an output voltage) based on the sensed temperature. For example, the temperature sensing circuit 1202 may provide an output signal in response to sensing a temperature exceeding a temperature threshold.

[0116] In some embodiments, the temperature sensing circuit 1202 is configured to provide its output as an input to the processing circuit 812. For example, the output of the temperature sensing circuit 1202 may be used as an input to a wake-up pin coupled to the processing circuit 812. Additionally or alternatively, the output of the temperature sensing circuit 1202 may directly power the processing circuit 812. Thus, in some embodiments, the processing circuit 812 may not be powered (e.g., it may be in an "off" or "power-off" state) before the temperature sensing circuit 1202 provides an output signal.

[0117] In some embodiments, after processing circuit 812 is powered on, processing circuit 812 may communicate with user feedback interface 808 to cause user feedback interface 808 to output feedback. For example, processing circuit 812 may cause user feedback interface 808 to provide feedback indicating the status of drug device 820. Such feedback may indicate to the user that drug delivery device 820 is ready for use.

[0118] Additionally or alternatively, after processing circuit 812 is powered on, processing circuit 812 may communicate with external device 850 via network 830. Processing circuit 812 may cause external device 850 to notify a user that the drug is ready for injection and / or display other information about drug delivery device 820 and / or the drug.

[0119] Fig.13 1 is a diagram illustrating an example temperature sensing circuit 1302 according to some embodiments of the techniques described herein. The temperature sensing circuit 1302 includes a battery 1322, resistors 1324a-d, and a comparator 1326. In some embodiments, the output of the comparator 1326 is provided as an input to a processing circuit, such as the processing circuit 812 described herein, including at least Figure 8 and 12 The processing circuit.

[0120] In some embodiments, resistors 1324a-d include resistors whose resistances cause comparator 1326 to switch between voltage output levels when operating in conjunction with battery 1322 and comparator 1326 and when exposed to temperatures within a specified temperature range. Table 1 shows example values ​​for components of temperature sensing circuit 1302 for causing comparator 1326 to switch between voltage output levels when temperature sensing circuit 1302 is exposed to temperatures between 9° C. and 11° C. However, it should be understood that any suitable values ​​may be used to cause comparator 1326 to switch between voltage output levels when temperature sensing circuit 1302 is exposed to any suitable temperature range, as aspects of the present technology are not limited in this regard.

[0121]

[0122]

[0123] Table 1. Example values ​​for components of temperature sensing circuit 1302.

[0124] Fig.14 An illustrative implementation of a computer system 1400 that can be used to perform any aspect of the techniques and embodiments disclosed herein is shown in . The computer system 1400 may include one or more processors 1410 and one or more non-transitory computer-readable storage media (e.g., memory 1420, and one or more non-volatile storage media 1430) and a display 1440. The processor 1410 may control writing data to and reading data from the memory 1420 and the non-volatile storage device 1430 in any suitable manner, as the various aspects of the invention described herein are not limited in this regard. In order to perform the functions and / or techniques described herein, the processor 1410 may execute one or more instructions stored in one or more computer-readable storage media (e.g., memory 1420, storage media, etc.), which may be used as a non-transitory computer-readable storage medium to store instructions for execution by the processor 1410.

[0125] In conjunction with the techniques described herein, code for, for example, identifying patients for inclusion in a clinical trial can be stored on one or more computer-readable storage media of the computer system 1400. The processor 1410 can execute any such code to provide any of the techniques described herein for identifying an object. Any other software, program, or instruction described herein can also be stored and executed by the computer system 1400. It should be understood that the computer code can be applied to any aspect of the methods and techniques described herein. For example, the computer code can be used to interact with an operating system to identify an object through conventional operating system processes.

[0126] The various methods or processes outlined herein may be encoded as software that can be executed on one or more processors that employ any of a variety of operating systems or platforms. In addition, such software may be written using any of a variety of suitable programming languages ​​and / or programming or scripting tools, and may also be compiled into executable machine language code or intermediate code that is executed on a virtual machine or suitable framework.

[0127] In this regard, various inventive concepts may be embodied as at least one non-transitory computer-readable storage medium (e.g., computer memory, one-time programmable memory, one or more floppy disks, compact disks, optical disks, tapes, flash memory, circuit configurations in field programmable gate arrays or other semiconductor devices, etc.), which is encoded with one or more programs that, when executed on one or more computers or other processors, implement various embodiments of the present invention. The non-transitory computer-readable medium is transportable so that the one or more programs stored thereon can be loaded onto any computer resource to implement various aspects of the present invention as described above.

[0128] The terms "program", "software" and / or "application" are used in this article in a general sense to refer to any type of computer code or computer executable instruction set that can be used to program a computer or other processor to implement various aspects of the above-mentioned embodiments. In addition, it should be understood that according to one aspect, one or more computer programs that implement the methods of the present invention when executed do not need to reside on a single computer or processor, but can be distributed in a modular manner between different computers or processors to implement various aspects of the present invention.

[0129] Computer executable instructions may be in a variety of forms, such as program modules that are executed by one or more computers or other devices. Typically, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. Typically, in various embodiments, the functionality of program modules may be combined or distributed as desired.

[0130] In addition, the data structure can be stored in a non-transient computer-readable storage medium in any suitable form. The data structure can have fields that are related by location in the data structure. This relationship can also be achieved by assigning storage locations to the fields in the non-transient computer-readable medium, which convey the relationship between the fields. However, any suitable mechanism can be used to establish the relationship between the information in the data structure fields, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0131] Various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed that perform the actions in an order different from the order shown, which may include performing some actions simultaneously, even though the actions are shown as sequential actions in the illustrative embodiments.

[0132] Unless expressly indicated to the contrary, the indefinite articles "a" and "an" as used herein in the specification and claims are to be understood as "at least one". As used herein in the specification and claims, when referring to a list of one or more elements, the phrase "at least one" is to be understood as at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, nor does it exclude any combination of elements in the list of elements. This allows for the optional presence of other elements in addition to the elements specifically identified in the list of elements to which the phrase "at least one" refers, whether or not these other elements are related to those specifically identified elements.

[0133] As used herein in the specification and claims, the phrase "and / or" should be understood to refer to "any or all two" of the elements so combined (i.e., elements that exist in combination in some cases and separately in other cases). Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether or not these other elements are related to those specifically identified. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising," a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; may refer to only B (optionally including elements other than A) in another embodiment; may refer to both A and B (optionally including other elements) in yet another embodiment, etc.

[0134] As used herein in the specification and claims, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as being inclusive, i.e., including multiple elements or at least one element in a list of elements, but also including more than one element, and optionally including other unlisted items. Only terms that clearly indicate the opposite, such as "only one" or "exactly one", or "consisting of..." used in the claims, refer to the inclusion of multiple elements or exactly one element in a list of elements. In general, when preceded by exclusive terms, such as "any", "one of", "only one" or "exactly one", "essentially consisting of...", the term "or" used herein should only be interpreted as indicating exclusive substitution (i.e., "one or the other, but not all two"), and when used in the claims, it should have the ordinary meaning used in the field of patent law.

[0135] The use of ordinal terms such as "first," "second," and "third" in the claims to modify claim elements does not in itself imply any priority, precedence, or order of one claim element relative to another, nor does it imply a temporal order in which method actions are performed. Such terms are merely used as labels to distinguish one claim element with a particular name from another element with the same name (except when an ordinal number is used).

[0136] The phraseology and terminology used herein is for the purpose of description only and should not be regarded as limiting. The use of "includes," "comprising," "having," "containing," "involving," and variations thereof, means to include the items listed thereafter and other items.

[0137] After describing several embodiments of the present invention in detail, it will be easy for those skilled in the art to think of various modifications and improvements. These modifications and improvements are intended to fall within the spirit and scope of the present invention. Therefore, the above description is only for example and is not intended to be limiting.

[0138] This disclosure describes various aspects, including but not limited to the following:

[0139] 1. A method, comprising: obtaining temperature data indicating a temperature from a temperature sensor of a drug delivery device; obtaining ambient light data indicating an amount of ambient light to which at least a portion of the drug delivery device is exposed from an ambient light sensor, wherein the drug delivery device further comprises: a reservoir configured to contain a drug; and an actuation button for initiating injection of the drug; determining, based on the temperature data, whether the temperature exceeds a temperature threshold; determining, based on the ambient light data, whether the amount of light exceeds an ambient light threshold; and outputting an indication that the drug delivery device is ready for use when the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold.

[0140] 2. The method according to aspect 1 further includes: determining whether the temperature increases over time based on the temperature data and previously obtained temperature data, wherein outputting the indication that the drug delivery device is ready for use also includes outputting the indication after determining that the temperature increases over time.

[0141] 3. The method of aspect 1, wherein the drug delivery device further comprises a visual indicator, and wherein outputting the indication that the drug delivery device is ready for use comprises outputting the indication via the visual indicator.

[0142] 4. The method of aspect 3, wherein the visual indicator comprises at least one light emitting diode (LED).

[0143] 5. The method of clause 1, wherein obtaining the temperature data and the ambient light data comprises obtaining the temperature data and the ambient light data after a specified duration has elapsed since a start-up event.

[0144] 6. The method of aspect 1, wherein obtaining the temperature data and the ambient light data comprises: receiving a wireless signal; and obtaining the temperature data and the ambient light data after a specified duration has elapsed since receiving the wireless signal.

[0145] 7. The method of clause 6, wherein the wireless signal comprises a Bluetooth Low Energy (BLE) signal.

[0146] 8. The method of aspect 1, wherein obtaining the temperature data comprises obtaining data indicative of a temperature of a drug contained within the drug delivery device.

[0147] 9. A method according to aspect 1, wherein the outputting step includes outputting the indication that the drug delivery device is ready for use after a period of time has passed after the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold, and after a period of time.

[0148] 10. The method according to aspect 1 also includes providing a first preheat indication when the temperature does not exceed the temperature threshold and / or the ambient light amount does not exceed the ambient light threshold, providing a second preheat indication during the timing of the elapsed period of time, or both.

[0149] 11. A system comprising a memory storing instructions, and a processor configured to execute the instructions to perform the method according to any one of aspects 1-10.

[0150] 12. A non-transitory computer-readable medium comprising instructions which, when executed by one or more processors on a computing device, are operable to cause the one or more processors to perform the method according to any one of aspects 1-10.

[0151] 13. A drug delivery device comprising a memory configured to store instructions, and a processor configured to execute the instructions to perform the method according to any one of aspects 1-10.

Claims

1. A method comprising: obtaining temperature data indicative of a temperature from a temperature sensor of the drug delivery device; obtaining ambient light data indicative of an amount of ambient light to which at least a portion of the drug delivery device is exposed from an ambient light sensor, wherein the drug delivery device further comprises: a reservoir configured to contain a drug; and an actuation button for initiating injection of the drug; Based on the temperature data, determining whether the temperature exceeds a temperature threshold; determining, based on the ambient light data, whether the amount of light exceeds an ambient light threshold; and When the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold, an indication is output that the drug delivery device is ready for use.

2. The method according to claim 1, further comprising: determining whether the temperature increases over time based on the temperature data and previously acquired temperature data, Wherein, outputting the indication that the drug delivery device is ready for use further comprises outputting the indication after determining that the temperature increases over time.

3. The method according to claim 1, in, The drug delivery device also includes a visual indicator, and Wherein outputting the indication that the drug delivery device is ready for use comprises outputting the indication via the visual indicator.

4. The method according to claim 3, wherein: The visual indicator includes at least one light emitting diode (LED).

5. The method according to claim 1, wherein: Obtaining the temperature data and the ambient light data includes obtaining the temperature data and the ambient light data after a specified duration has elapsed since a start-up event.

6. The method according to claim 1, wherein: Obtaining the temperature data and the ambient light data includes: receiving wireless signals; and The temperature data and the ambient light data are obtained after a specified duration has elapsed since the wireless signal was received.

7. The method according to claim 6, wherein: The wireless signal includes a Bluetooth Low Energy (BLE) signal.

8. The method according to claim 1, wherein: Obtaining the temperature data includes obtaining data indicative of a temperature of a drug contained within the drug delivery device.

9. The method according to claim 1, wherein: The outputting step includes outputting the indication that the drug delivery device is ready for use after a period of time has elapsed after the temperature exceeds the temperature threshold and the amount of ambient light exceeds the ambient light threshold, and after a period of time.

10. The method of claim 1, further comprising providing a first preheat indication when the temperature does not exceed the temperature threshold and / or the amount of ambient light does not exceed the ambient light threshold, providing a second preheat indication during the timing of the elapsed period of time, or both.

11. A system comprising a memory storing instructions, and a processor configured to execute the instructions to perform the method according to any one of claims 1-10.

12. A non-transitory computer readable medium comprising instructions which, when executed by one or more processors on a computing device, are operable to cause the one or more processors to perform the method according to any one of claims 1-10.

13. A drug delivery device comprising a memory configured to store instructions, and a processor configured to execute the instructions to perform the method according to any one of claims 1-10.

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