Drug delivery system, method of providing feedback related to use of drug delivery system, and method of detecting use of drug delivery system

Abstract

A drug delivery device includes an injection pen and a cap. The pen cap comprises one or more detectors, a vibration motor and a controller. The controller is configured to receive information about physical interactions between the cap and the injection pen from the one or more detectors of the cap, analyze the received information to identify at least one of an incorrect physical interaction or a correct physical interaction between the cap and the injection pen, and provide feedback via a vibration motor of the drug delivery device in response to identifying at least one of an incorrect physical interaction or a correct physical interaction between the cap and the injection pen.

Description

[0001] Priority declaration

[0002] This application claims the benefit of the filing date of U.S. Provisional Patent Application Serial No. 63 / 367,443, filed on June 30, 2022, "MEDICINE DELIVERY SYSTEM, METHODS OF PROVIDING FEEDBACK RELATED TO USE OF MEDICINE DELIVERY SYSTEM, AND METHODS OF DETECTING USAGES OF MEDICINE DELIVERY SYSTEM," the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to drug delivery systems and methods that improve medication therapy management by providing confirmation of proper use of a drug delivery device, and generating awareness of improper use of a drug delivery device. Background Art

[0004] Drug delivery dosing pens are commonly used to deliver a variety of drugs for a variety of different drug treatments. The treatments typically include a dosing regime for one or more of growth hormone, insulin, fertility drugs, homozygous familial hypercholesterolemia (HoFH) treatment, etc.

[0005] Regarding insulin therapy, diabetes is a chronic metabolic disorder caused by the inability of the human pancreas to produce sufficient amounts of the insulin hormone, so that the human metabolism cannot provide the proper absorption of sugar and starch. This may lead to hyperglycemia or hypoglycemia. Hyperglycemia refers to the presence of excess glucose in the plasma. Sustained hyperglycemia is associated with various severe symptoms and life-threatening long-term complications (such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage with the risk of amputation). Hypoglycemia refers to a situation where the glucose level is below the standard range. Hypoglycemia is associated with various symptoms (such as clumsiness, difficulty speaking, confusion) and life-threatening long-term complications (such as loss of consciousness, epileptic seizures or death). Because it is not yet possible to cure, it is necessary to provide permanent treatment for constant blood sugar control, so that the blood sugar level is constantly maintained within the normal range. This blood sugar control is achieved by periodically supplying external drugs to the patient's body to reduce the elevated blood sugar level.

[0006] Typically, permanent treatment is required to maintain an appropriate blood sugar level within the normal range. The maintenance of an appropriate glucose level is achieved by periodically supplying insulin to a patient with diabetes (PWD). Maintaining an appropriate blood sugar level can bring a significant cognitive burden to PWD and affect many aspects of PWD life. For example, the cognitive burden of PWD can be attributed to tracking diet, continuous inspection, and small process corrections to blood sugar levels. PWD can include injecting insulin, tracking insulin dosage and glucose, deciding how much insulin to inject, how often to inject, at which position to inject insulin, and how to arrange the time of insulin administration relative to diet and / or glucose fluctuations to adjust blood sugar levels. The above factors only constitute a part of the significant cognitive burden of PWD.

[0007] The following example of a typical daily activity of a PWD further illustrates the significant cognitive burden of a PWD. In the morning, the first thought / action of a PWD is usually related to their glucose, such as, what is their blood sugar level? How is their blood sugar level overnight? And how do they feel now? When checking their blood sugar level (e.g., using a blood glucose meter or monitor), the PWD can then consider what actions to take, such as adjusting their morning activities, changing the time or food to eat breakfast, or determining to inject a rapid-acting (RA) insulin and deciding at which site to inject the rapid-acting (RA) insulin. Before they eat breakfast (or any meal), the PWD will consider the amount of food they plan to eat and the type of food, and may modify their RA insulin dose based on the carbohydrate content of the food they choose to eat. Before administering RA insulin, the PWD will try to remember when their last dose of insulin was injected, what happened when they last ate a specific meal, and how they felt.

[0008] Before leaving the house, PWDs consider whether they have adequate supplies for glucose monitoring or insulin administration, among other things. This can include batteries, charging equipment, backup supplies, glucose testing supplies, and insulin supplies to treat high blood sugar levels. Additionally, PWDs need to consider any physical activities that could affect their glucose (e.g., taking children to school, going to the gym, riding a bike), as exercise could cause their blood sugar to be lower than expected. Before even driving a vehicle, PWDs check their glucose to determine if it is at a safe driving level.

[0009] As lunchtime approaches, PWDs consider their glucose before eating lunch, such as when they might expect to eat and what they expect to eat throughout the day. Therefore, PWDs count carbohydrates in their head and adjust their insulin doses. PWDs also consider recent insulin doses and whether those doses are still lowering their blood sugars. This is all done in parallel with what they are doing in their busy day, so PWDs often forget or fail to fully consider all of the above factors.

[0010] Throughout the day, PWDs frequently check glucose levels, especially on days when their activities differ from a typical day. This constant thinking, checking, and planning can be exhausting, especially when each check requires decision-making, math, and possible behavior changes. Additionally, during the day, PWDs may check supply inventory, talk with a healthcare provider (HCP), refill prescriptions, and contact their health insurance to discuss their treatments and / or supplies.

[0011] In the evening, PWDs may have to inject their daily insulin dose of long-acting (LA) insulin. Additionally, PWDs may want to make sure their glucose remains stable before they go to sleep. If they use an infusion pump, they must check if their pump is low on insulin and if they need to refill before bed. If they have a continuous glucose monitor, they must check it and see if it is working. Even so, depending on what they eat for dinner, the nighttime insulin may not keep their glucose stable. Glucose levels at night may interfere with sleep and increase anxiety that may disrupt sleep.

[0012] Therefore, managing diabetes requires a high level of attention to detail throughout the day. Even with careful planning and self-monitoring, PWDs may skip doses, double doses, or administer the wrong amount and / or type of insulin. Not enough insulin can lead to high blood sugar levels, while too much insulin can lead to low blood sugar levels, which can cause clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death.

[0013] To assist in self-treatment, some diabetes treatment devices (e.g., but not limited to, blood glucose meters, insulin pumps) are equipped with an insulin bolus calculator that enables the user to input an estimate (e.g., a numerical estimate) of the amount of carbohydrates (or additionally or alternatively, protein, fat, or other dietary data) that has been or will be ingested, and the bolus calculator outputs a recommended size for an insulin bolus dose. Although the bolus calculator eliminates some of the mental calculations that the user has to do in determining an appropriate insulin bolus dose, the bolus calculator still subjects the user to the mental task of assessing the composition of their meal, may require the use of an auxiliary device, and often requires manual data entry.

[0014] Although conventional drug delivery systems may eliminate some of the mental burden on PWDs in determining appropriate recommendations related to insulin administration, drug delivery systems still subject PWDs to one or more of the mental tasks of manually evaluating treatment data, manually determining dosing recommendations, manually determining injection sites, and manually entering data. Summary of the invention

[0015] Various embodiments described below provide benefits and / or solve one or more of the foregoing or other problems in the art using systems and methods for using a drug delivery device. Embodiments include a method of providing feedback to a user of a drug delivery device. The method includes: receiving information from one or more detectors of a pen cap of a drug delivery device, analyzing the received information to identify at least one incorrect or correct use of the drug delivery device, and in response to identifying one or more of the incorrect use or correct use, providing feedback via one or more feedback components of the pen cap of the drug delivery device.

[0016] Some embodiments include a drug delivery device. A drug delivery device may include an injection pen and a pen cap. The pen cap may include one or more detectors, a vibration motor, and a controller. The controller may include at least one processor, and at least one non-transitory computer-readable storage medium storing instructions thereon, which instructions, when executed by the at least one processor, cause the controller to: receive information about a physical interaction between the pen cap and the injection pen from one or more detectors of the pen cap, analyze the received information to identify at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen, and provide feedback via the vibration motor of the drug delivery device in response to identifying at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen.

[0017] One or more embodiments include a non-transitory computer-readable medium storing instructions thereon, which, when executed by at least one processor, cause the at least one processor to perform steps including: receiving information about a physical interaction between a pen cap and an injection pen of a drug delivery device, analyzing the received information to identify at least one incorrect physical interaction between the pen cap and the injection pen, and in response to identifying at least one incorrect physical interaction, providing tactile feedback via the pen cap. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Various embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0019] Figure 1 shows a perspective view of a drug delivery device according to one or more embodiments;

[0020] Figure 2 According to one or more embodiments, Figure 1 Schematic representation of a drug delivery device;

[0021] Figure 3 A flow chart showing a method of providing feedback to a user regarding the use of a drug delivery device according to one or more embodiments; and

[0022] Figure 4 A block diagram of an exemplary computing device is illustrated in accordance with one or more embodiments. DETAILED DESCRIPTION

[0023] The illustrations presented herein are not intended to be actual views of any particular drug delivery device or any of its components, but are merely idealized representations used to describe the present invention.

[0024] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0025] As used herein, the term "may" with respect to a material, structure, feature, function, or method act indicates that it is intended for use in the implementation of an embodiment of the present disclosure, and this term is used in preference to the more restrictive term "is" to avoid any suggestion that other compatible materials, structures, features, functions, and methods that may be used in combination therewith should or must be excluded.

[0026] As used herein, any relational terms, such as “first”, “second”, etc., are used for clarity and convenience in understanding the present disclosure and the drawings, and do not imply or rely on any particular preference or order unless the context clearly indicates otherwise.

[0027] As used herein, the term "substantially" with reference to a given parameter, property, action, or condition means and includes to the extent that one skilled in the art will understand that the given parameter, property, or condition is met with a small degree of variation, such as within acceptable manufacturing tolerances. As an example, depending on the particular parameter, property, or condition that is substantially met, the parameter, property, or condition may be at least 90.0% met, at least 95.0% met, at least 99.0% met, or even at least 99.9% met.

[0028] As used herein, the term "about" used with reference to a given parameter is inclusive of the stated value and has the meaning dictated by the context (e.g., it includes the degree of error associated with measurement of the given parameter, as well as variations caused by manufacturing tolerances, etc.).

[0029] Embodiments of the present disclosure include a drug delivery device, which has one or more detectors (e.g., sensors) for detecting the interaction between the pen cap of the drug delivery device and the injection pen (e.g., insulin pen) of the drug delivery device and / or detecting the interaction between the drug delivery device and the user (e.g., drug administration action). In addition, the drug delivery device includes one or more feedback components (e.g., tactile, visual and / or audio feedback components) for providing feedback about the interaction between the pen cap and the injection pen and / or the interaction between the drug delivery device and the user to the user. For example, embodiments of the present disclosure include providing feedback via one or more feedback components in response to the following: the injection pen is inserted into the pen cap after the drug is administered, a new injection pen (e.g., insulin pen) is inserted into the pen cap, the correct injection pen is inserted into the pen cap, the injection pen is inserted into the pen cap by mistake, the injection pen is inserted into the pen cap together with a needle and / or a sheath, and / or the injection pen is removed from the pen cap. In addition, feedback can indicate correct and / or incorrect interaction via duration, amplitude, frequency and / or rhythm of, for example, feedback. For example, feedback can be specific to correct and / or incorrect interaction.

[0030] Accordingly, the drug delivery device described herein can provide advantages over conventional delivery devices. For example, the drug delivery device of the present disclosure can improve the user experience of using the drug delivery device by providing confirmation (e.g., feedback) of correct actions (e.g., correct use) and notification (e.g., creating perception) of incorrect actions (e.g., incorrect use) when using the drug delivery device. As a non-limiting example, the drug delivery device can provide feedback through tactile feedback (e.g., vibration feedback), and the tactile feedback can create a more consistent user experience when inserting the injection pen into the pen cap and removing the injection pen from the pen cap compared to conventional delivery devices. In addition, a consistent user experience can reduce learning time and can reduce user confusion compared to conventional delivery devices.

[0031] For example, users of conventional delivery devices may experience various challenges when operating the delivery devices. One challenge that users may experience when using conventional delivery devices is "diabetic fatigue syndrome" (DFS). As used herein, DFS can be defined as "a multifactorial syndrome of fatigue or fatigability occurring in diabetic patients," which can be caused by various factors. Accordingly, reducing learning barriers and reducing confusion when using a delivery device can reduce the cognitive burden on the user and can improve the user experience. Another challenge that users may experience is neuropathy. PWDs often suffer from nerve damage; accordingly, providing feedback via tactile feedback can benefit users with limited fine motor skills and dexterity. Similarly, tactile feedback can benefit users with hearing and / or visual impairments. In view of the foregoing, the drug delivery device of the present disclosure can reduce the cognitive burden on the user by providing confirmation of correct actions and notification of incorrect actions (e.g., creating perception).

[0032] Embodiments of the present disclosure include providing tactile feedback, which includes vibrations of a specified duration, amplitude, frequency, and / or rhythm. In addition, the parameters of the feedback (e.g., tactile parameters) can depend on the drug regimen and / or the drug (e.g., the type of insulin) present in the injection pen (e.g., present in the cartridge in the injection pen) and / or be customized based on the drug regimen and / or the drug present in the injection pen. The parameters of the feedback can be adjusted automatically and / or manually to address the environmental and / or other challenges inherent to the user receiving the drug regimen (e.g., using a drug delivery device). For example, the parameters can depend on the user profile of the user and / or be customized based on the user profile of the user. For example, depending on the fine motor skills of the user, parameters such as the length and amplitude of the tactile feedback can be adjusted to accommodate user preferences and / or abilities.

[0033] Figure 1 is a perspective view of a drug delivery device 100 according to one or more embodiments of the present disclosure. Figure 1 As depicted in , in some embodiments, the drug delivery device 100 may include an injection pen 102 (e.g., an insulin pen) and a pen cap 104. In some embodiments, the drug delivery device 100 may include one or more of a quick-acting insulin (QAI) pen or a long-acting insulin (LAI) pen. As discussed in more detail below, the pen cap 104 may wirelessly communicate with one or more of a client device 106, an application 108 of the client device 106, a glucose monitor 110, and / or an external system / resource 114 via one or more networks 105.

[0034] In some embodiments, the applications 108 (e.g., tool applications) of the client device 106 may include a medication therapy management system that enables a user to manage their medication therapy and at least partially control and / or configure the drug delivery device 100 (e.g., adjust settings of the drug delivery device 100). As a non-limiting example, the application 108 may be directed to help the user manage the user's insulin therapy. In some instances, the application 108 may be a web application for managing the user's insulin therapy. In some embodiments, the application 108 may be local to the client device 106. In other embodiments, the application 108 may be stored and / or at least partially operated via a cloud computing service. In additional embodiments, the application 108 may be stored and / or at least partially operated on the drug delivery device 100. In some embodiments, the client device 106 may execute one or more applications (e.g., application 108) for performing the functions of the various embodiments and processes described herein.

[0035] In one or more embodiments, the application 108 may be a native application installed on the client device 106. For example, the application 108 may be a mobile application installed and run on a mobile device such as a smart phone or a tablet. The application 108 may be specific to the operating system of the client device 106. In addition, in some embodiments, the application 108 may be a client application that is associated with at least a portion of the medication therapy management system and / or the medication delivery device 100 (e.g., the pen cap 104 of the medication delivery device 100) and is configured to be able to interact directly with the medication therapy management system through the application 108.

[0036] The client device 106, the glucose monitor 110, one or more external systems / resources 114, and the drug delivery device 100 can communicate via one or more networks 105. In one or more embodiments, the one or more networks 105 may include a combination of a cellular or mobile telecommunications network, a public switched telephone network (PSTN), and / or the Internet or the World Wide Web, which facilitates data transmission between the client device 106 (e.g., the injection site determination system 106), the glucose monitor 110, the one or more external systems / resources 114, and the drug delivery device 100. However, the network 105 may include various other types of networks using various communication technologies and protocols, such as a wireless local area network (WLAN), a wide area network (WAN), a metropolitan area network (MAN), other telecommunications networks, or a combination of two or more of the foregoing networks. In additional embodiments, the client device 106, the glucose monitor 110, the one or more external systems / resources 114, and the drug delivery device 100 can communicate via Bluetooth and near field communications in addition to or as an alternative to the one or more networks 105.

[0037] although Figure 1 A particular arrangement of the client device 106, glucose monitor 110, one or more external systems / resources 114, one or more networks 105, and the drug delivery device 100 is shown, but various additional arrangements are possible. For example, the drug delivery device 100, glucose monitor 110, and / or one or more external systems / resources 114 may communicate directly with the client device 106, bypassing the network 105.

[0038] For example, a user may interface with the client device 106 to utilize a medication therapy management system in order to enter user preferences, adjust a profile, view notifications, interact with a provider, adjust settings of the medication delivery device 100, and the like.

[0039] Client device 106 may be any one or more of a variety of types of computing devices. For example, client device 106 may include a mobile device such as a mobile phone, smart phone, PDA, tablet computer, or laptop computer, or a non-mobile device such as a desktop computer or other type of computing device. Figure 4 Additional details regarding client device 106 are discussed.

[0040] The external system / resource 114 may include additional systems that are docked with the client device 106, the application 108, the medication management system, and / or the medication delivery device. In some embodiments, the external system / resource 114 may include additional medical devices. The medical device may include additional insulin delivery systems, including but not limited to insulin delivery devices (e.g., insulin pumps, injection pens, and inhalers), glucose sensors (e.g., CGM and blood glucose meters), treatment managers (e.g., controllers for controlling the open-loop and closed-loop delivery of insulin or aspects of delivering insulin, and a recommendation system for providing treatment recommendations to users and / or health providers) and combinations thereof. In some embodiments, the external system / resource 114 may include subject matter expert input data, clinical literature, conventional drug regimens, etc. In various embodiments, the external system / resource 114 may include (multiple) treatment management systems. The treatment management system may include a diabetes management system for monitoring blood sugar data and treatment data and managing treatment settings. In further embodiments, the external system / resource 114 may include health care provider equipment. In additional embodiments, the external system / resource 114 may include a cloud computing platform and / or one or more servers. Additionally, the medication therapy management system may operate at least in part on external systems / resources 114 .

[0041] In some embodiments, glucose monitor 110 may include any known glucose monitor. For example, glucose monitor may include one or more of a continuous glucose monitor (CGM), a rapid glucose monitor, a blood glucose meter (BGM), or any other suitable sensor. In the case of CGM and a rapid glucose monitor, CGM and a rapid glucose monitor may provide glucose data based on the user's interstitial fluid glucose level, and the interstitial fluid glucose level may be related to the blood glucose level. BGM may be configured to provide blood glucose data based on a blood sample, generally. Accordingly, the term "blood glucose" is not limited to using only blood glucose data, values, levels, etc., but also includes interstitial fluid glucose levels and any intermediate measurements.

[0042] Figure 2 The invention comprises a pen cap 104 and an injection pen 102. Figure 1 Schematic diagram of a drug delivery device 100. Figure 1 and Figure 2 , the pen cap 104 may include: a display screen 120; one or more inputs 116 (e.g., dials, buttons, and / or touch screen areas) for the user to set the dose to be delivered; one or more inputs 118 for entering meal information, entering insulin dosage information, responding to recommendations, etc.; one or more indicator lights 122, which may light up to indicate that it is transmitting data, light up to indicate that the user's attention is required, and / or light up to indicate whether the dose capture function is working. Additionally, the pen cap 104 may utilize the display screen 120 to display one or more of an estimated glucose value (EVG), a unit of EVG, a trend indicator of EVG, a recommended dosing, an identification of the insulin type, a recommended site injection, the time and amount of a previous dose, and / or an onboard insulin value to remind the user of their recent dosing. In some embodiments, the display screen 120 of the pen cap 104 may include a touch screen, which may include one or more inputs 116 and / or one or more inputs 118. Additionally, the pen cap 104 itself may include dose capture technology.

[0043] Still refer to Figure 1 and Figure 2, the pen cap 104 may include a controller 124, the controller 124 including a processor 126, a data storage 128 (or memory), and a communication subsystem 130. The communication subsystem 130 can enable wireless communication between the pen cap 104 and the client device 106 and / or the glucose monitor 110. In some instances, the communication subsystem 130 may include a near field communication (NFC) chip. In some instances, the communication subsystem 130 may include a Bluetooth low energy (BLE) chip. In some instances, the communication subsystem 130 may include an optical communication device, an infrared communication device, a wireless communication device (such as an antenna) and / or a chipset (such as a Bluetooth device (e.g., Bluetooth low energy, classic Bluetooth, etc.), a near field communication (NFC) device, an 802.6 device (e.g., a metropolitan area network (MAN), a Zigbee device, etc.), a WiFi device, a WiMax device, a cellular communication facility, etc.), etc. In these and other cases, the communication subsystem 130 can exchange data with a network and / or any other device or system described in the present disclosure.

[0044] Additionally, in some embodiments, the pen cap 104 may include a power source 132, which may include a rechargeable or non-rechargeable battery. Furthermore, the pen cap 104 may include a pen type detector 134, a microswitch 136, (multiple) optical sensors 138, and (multiple) position sensors 140. In one or more embodiments, the controller 124 may determine the pen type based on data from the pen type detector 134. The controller 124 may also use one or more of the microswitch 136, (multiple) optical sensors 138, and (multiple) position sensors 140 to determine the position of the plunger 142 within the injection pen 102. Based on the determined position of the plunger 142, a dosing event and / or the amount of insulin delivered may be determined by the controller 124.

[0045] In addition, the pen cap 104 may include one or more sensors / detectors 144 (hereinafter referred to as "one or more detectors 144"), which are operably coupled to the controller 124 and are used to determine and identify user interaction with the pen cap 104, the state of the pen cap 104, the interaction between the pen cap 104 and the injection pen 102, and / or the orientation of the pen cap 104 relative to the injection pen 102, and vice versa. For example, the one or more detectors 144 may include one or more of an injection pen entry detector, an injection pen insertion level detector, an injection pen tension detector, an accelerometer, a temperature sensor, or a fastening force detector.

[0046] The injection pen entry detector may be disposed at an opening of the pen cap 104 that is configured to receive the injection pen 102. In some embodiments, the injection pen entry detector may include one or more of a proximity sensor, an infrared sensor, or an image sensor. In one or more embodiments, the injection pen entry detector may include a contactless sensor. The injection pen entry detector may be used to detect entry and / or removal of the injection pen 102 and provide information (e.g., data) to the controller 124 regarding whether the injection pen 102 is inserted into the pen cap 104 and / or removed from the pen cap 104. In some embodiments, the proximity sensor may include one or more optical proximity sensors, sound proximity sensors, magnetic proximity sensors, and / or capacitive proximity sensors. In addition, the infrared sensor may include one or more of a transmissive or reflective infrared sensor. The image sensor may include one or more of a charge coupled device sensor or a CMOS image sensor.

[0047] The injection pen insertion level detector may be disposed near the end (e.g., bottom) of the pen cap 104 opposite to the opening of the pen cap 104. In some embodiments, the injection pen insertion level detector may include one or more of a proximity sensor or a force sensor. The injection pen insertion level detector may be used to detect when the injection pen 102 reaches the end of the pen cap 104 opposite to the opening of the pen cap 104, and provide information (e.g., data) to the controller 124 about when the injection pen 102 has been inserted into the pen cap 104 to the extent that a portion of the injection pen 102 has reached the end of the pen cap 104 opposite to the opening of the pen cap 104 (e.g., fully inserted into the pen cap 104). The proximity sensor may include any of the above-mentioned proximity sensors. The force sensor may include one or more of a load sensor, a strain gauge, a pressure sensor, or any other known force sensor.

[0048] The injection pen tension detector may be disposed within one or more portions (e.g., snaps, radial protrusions, friction snaps, etc.) of the pen cap 104, the one or more portions being configured to grip (e.g., fasten, engage, etc.) the injection pen 102 via mechanical force when the injection pen 102 is disposed within the pen cap 104. In one or more embodiments, the injection pen tension detector may include a force sensor. The injection pen tension detector may be used to determine the amount of force that the injection pen 102 is experiencing at a given moment, and provide information (e.g., data) about the force that the injection pen 102 is experiencing to the controller 124. In some embodiments, the injection pen tension detector may be configured to determine the amount of force that the injection pen 102 is experiencing in a direction parallel to the longitudinal axis of the pen cap 104. The force sensor may include any of the force sensors described above. In some embodiments, data from the injection pen tension detector may be used as a safety mechanism to enable a user to remove the injection pen 102 from the pen cap 104 if the fastening mechanism is in an engaged state (i.e., the operation of the fastening mechanism fails).

[0049] The fastening force detector may be disposed in one or more portions of the pen cap 104 that are configured to grip (e.g., fasten, engage, etc.) the injection pen 102 via mechanical force when the injection pen 102 is disposed in the pen cap 104. In one or more embodiments, the fastening force detector may include a force sensor. The fastening force detector may be used to determine the amount of force applied to the injection pen 102 by the pen cap 104 at a given moment and provide information (e.g., data) about the force applied to the injection pen 102 to the controller 124. In some embodiments, the fastening force detector may be configured to determine the amount and direction of force applied to the injection pen 102 by the pen cap 104 (e.g., a fastening mechanism of the pen cap 104). The force sensor may include any of the force sensors described above.

[0050] The accelerometer may be disposed within any portion of the cap 104. The accelerometer may be used to identify movement and / or orientation of the cap 104 and provide information (e.g., data) about the movement and / or orientation of the cap 104 to the controller. Information received from the accelerometer may be used in the operation of the cap 104's wake-up features, sleep modes, and power consumption.

[0051] The temperature sensor may be disposed within any portion of the pen cap 104. The temperature sensor may be used to monitor the temperature of the pen cap 104, the injection pen 102, or both, and provide information (e.g., data) about the temperature sensor of the pen cap 104 to the controller. Information received from the temperature sensor may be used to determine drug viability, optimize battery charging, and determine usage patterns.

[0052] Still reference Figure 1 and Figure 2, the cap 104 may further include one or more feedback components 146 for providing feedback to the user. The one or more feedback components 146 may be disposed in or on any portion of the cap 104 and may be operably coupled to the controller 124. The one or more feedback components 146 may include one or more of a vibration motor (e.g., a solenoid), an audio transducer, or a display (e.g., display screen 120). As described in more detail below, the feedback component 146 may be used to provide feedback to the user to indicate a correct interaction of the user with the pen cap 104, a correct state of the pen cap 104, a correct interaction between the pen cap 104 and the injection pen 102 (e.g., the injection pen 102 is correctly inserted into the pen cap 104), and / or a correct orientation of the pen cap 104 relative to the injection pen 102, or vice versa, and / or to indicate an incorrect interaction of the user with the pen cap 104, an incorrect state of the pen cap 104, an incorrect interaction between the pen cap 104 and the injection pen 102 (e.g., the injection pen 102 is incorrectly inserted into the pen cap 104), and / or an incorrect orientation of the pen cap 104 relative to the injection pen 102. Additionally, the feedback component 146 may be used to provide feedback to the user regarding a scan of a continuous glucose monitor or blood glucose meter, battery level, temperature, viability of a medication within the injection pen 102, incorrect injection pen insertion, and / or insertion of a foreign object.

[0053] The vibration motor may include any conventional vibration motor (e.g., a haptic solenoid) and may be configured to provide tactile feedback to the user. In some embodiments, the vibration motor may include a specified motor. In additional embodiments, the vibration motor may be part of another element of the cap 104, such as an actuating motor for another operation of the cap 104.

[0054] The audio transducer may include one or more of an audio speaker or a piezoelectric transducer.

[0055] The display may include any conventional display for providing (e.g., displaying) information. For example, the display may include one or more of electronic paper (e.g., electronic ink (e-ink) or electrophoretic display), a liquid crystal display (LCD) screen, a light emitting diode (LED) screen, or any other conventional display.

[0056] Figure 3 A flow chart of a method 300 of providing feedback to a user regarding the use of a drug delivery device is shown. Figure 1-3 , the method 300 may include receiving information (eg, data) from one or more sensors / detectors 144, such as Figure 3302 of . For example, the controller 124 may receive information from one or more of a pen entry detector, a pen insertion level detector, a pen tension detector, an accelerometer, a temperature sensor, or a fastening force detector, such as any of the above-described detectors 144. In some embodiments, the controller 124 may receive the information via one or more of a wireless or wired connection. In one or more embodiments, the controller 124 may provide at least a portion of the received information to the client device 106.

[0057] In some embodiments, the controller 124 may receive information in response to an event. For example, the controller 124 may receive information in response to a user's interaction with one or more of the injection pen 102 or the pen cap 104 (e.g., one or more of the detectors 144 detects a user interaction). The user interaction may include one or more of the following: the user inserts the injection pen 102 into the pen cap 104 (e.g., a capping event), the user removes the injection pen 102 from the pen cap 104 (e.g., an uncapping event), or a drug administration action or event. The drug administration action and drug administration event may include any of the drug administration actions and drug administration events described in U.S. Application No. 16 / 442,281 of Bowland et al., filed on June 14, 2019, and / or U.S. Patent No. 11,154,660B2 of Sjolund et al., filed on December 12, 2018, the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the controller 124 may receive information in response to the time elapsed since a user interaction (e.g., an event). In one or more embodiments, the controller 124 may receive information in response to a measured temperature. In some embodiments, the controller 124 may receive information continuously.

[0058] In one or more embodiments, the information received from the detector 144 may include one or more of the following: an indication of the injection pen 102 entering and / or being removed from the pen cap 104, an indication of when the injection pen 102 reaches the end of the pen cap 104 opposite the opening of the pen cap 104, an indication of the amount of force experienced by the injection pen 102 at a given moment, and an indication of the amount of force applied to the injection pen 102 by the pen cap 104 at a given moment, an indication of the movement and / or orientation of the pen cap 104, and / or an indication of the temperature of the pen cap 104.

[0059] In response to receiving information (eg, data) from one or more sensors / detectors 144, method 300 may include analyzing the information, such as Figure 3As shown in action 304 of . For example, the controller 124 may analyze the received information. In additional embodiments, the controller 124 may provide the received information to a server (e.g., an external system / resource 114) and / or a client device 106 (e.g., a mobile phone), and the server and / or the client device 106 may analyze the received information. In some embodiments, analyzing the received information may include identifying the correct use and / or incorrect use of the injection pen 102 and / or the pen cap 104. As used herein, the term "use" may refer to capping the injection pen 102 with the pen cap 104, uncapping the pen cap 104 from the injection pen 102, administering a drug via the injection pen 102 and the pen cap 104, or any other typical use of the pen cap or injection pen when performing a drug (e.g., insulin) therapy. Additionally, "use" may refer to inserting the injection pen 102 into the pen cap 104 after administering the drug, inserting a new injection pen into the pen cap 104, and inserting the injection pen 102 with or without a needle and / or sheath into the pen cap 104. As described above, identifying the use of the injection pen 102 and / or the pen cap 104 may include identifying proper use and / or improper use of the injection pen 102 and / or the pen cap 104 .

[0060] As a non-limiting example, the controller 124 may determine whether the injection pen 102 has been correctly or incorrectly inserted into the pen cap 104. In some embodiments, the controller 124 may use information from one or more of the injection pen entry detector, the injection pen insertion level detector, and the fastening force detector to determine whether the injection pen 102 has been correctly or incorrectly inserted into the pen cap 104. For example, the controller 124 may determine whether the injection pen 102 has been sufficiently inserted into the pen cap 104 (e.g., whether the longitudinal end of the injection pen 102 is within a predetermined distance of the end of the pen cap 104) via the injection pen entry detector and / or the injection pen insertion level detector. Additionally, the controller 124 may determine whether the force applied to the injection pen 102 is within a predetermined range (e.g., an appropriate range) via the fastening force detector.

[0061] In response to determining that the injection pen 102 has been sufficiently inserted into the pen cap 104 and the force applied to the injection pen 102 is within a predetermined appropriate range, the controller 124 may determine that the injection pen 102 has been properly inserted into the pen cap 104 and constitutes a correct use (e.g., interaction). In response to determining that the injection pen 102 has been insufficiently inserted into the pen cap 104 or the force applied to the injection pen 102 is outside the predetermined appropriate range, the controller 124 may determine that the injection pen 102 has been improperly inserted into the pen cap 104 and constitutes an incorrect use (e.g., interaction).

[0062] As another non-limiting example, the controller 124 may determine whether a capping or uncapping event of the pen cap 104 is properly aligned with a scheduled medication administration action and / or a detected medication administration action. For example, the controller 124 may determine whether the pen cap 104 has been uncapped from the injection pen 102 before or at the time of the scheduled medication administration action. Additionally, the controller 124 may determine whether the pen cap 104 has been capped onto the injection pen after the scheduled and / or detected medication administration action. In some embodiments, the controller 124 may determine how long the pen cap 104 has been uncapped from the injection pen 102 and whether the amount of time the pen cap 104 has been uncapped from the injection pen 102 is sufficient to perform a medication administration action.

[0063] In response to determining that the capping and / or uncapping events of the pen cap 104 are properly aligned with the scheduled and / or detected medication administration action, the controller 124 can determine or infer that the medication administration action occurred properly and constitutes a correct use (e.g., interaction). In response to determining that the capping and / or uncapping events of the pen cap 104 are not properly aligned with the scheduled and / or detected medication administration action, the controller 124 can determine or infer that the medication administration action did not occur and constitutes an incorrect use (e.g., interaction).

[0064] As described above, the controller 124 may also determine, via one or more of the detectors 144, (1) when a new injection pen 102 is inserted into the pen cap 104, (2) when a correct or incorrect injection pen 102 is inserted into the pen cap 104, (3) when the injection pen 102 is inserted into the pen cap 104 with or without a needle and / or sheath, (4) the orientation of the injection pen 102 and / or the pen cap 104, and (5) the temperature to which the injection pen 102 and / or the pen cap 104 is subjected. In addition, for each of the foregoing examples, the controller 124 may identify a use (e.g., interaction) relative to a detected or scheduled drug administration action. In addition, for each of the foregoing examples, the controller 124 may determine whether the use (e.g., interaction) is correct or incorrect.

[0065] In response to analyzing the received information, method 300 may include determining feedback to provide to the user, such as Figure 3 As shown in action 306 of . For example, the controller 124 can use the above Figure 3 The controller 124 may determine the feedback to be provided to the user based at least in part on whether the analysis indicates correct and / or incorrect use of the injection pen 102 and / or pen cap 104, as discussed in further detail below.

[0066] In some embodiments, determining feedback to be provided to the user may include determining whether feedback to the user is desired (e.g., necessary or appropriate) given an analysis of the received information. For example, if incorrect use is identified via analysis, the controller 124 may determine that the feedback is suitable for making people aware of incorrect use, indicating the need for corrective action, and / or serving as an alarm. As another non-limiting example, if correct use is identified via analysis, the controller 124 may determine that the feedback is suitable for indicating correct use to the user (e.g., the user correctly performed the action (e.g., capping and / or feeding action)) and / or serving as positive reinforcement for the action. In some embodiments, if correct regular use is identified via analysis, the controller 124 may determine that feedback is not desired or necessary. In some embodiments, determining whether feedback to the user is desired may be based at least in part on a user profile and / or user preferences (e.g., previously made selections).

[0067] In some embodiments, only certain uses (e.g., actions) are categorized as needing feedback. For example, in one or more embodiments, uses that are determined and / or categorized (e.g., categorized by a provider) as being essential or unwanted to a user's insulin regimen can be categorized as needing feedback. For example, a dosing action, a capping action, and / or an uncapping action can be categorized as needing feedback.

[0068] In one or more embodiments, determining the feedback to be provided to the user may include determining the type of feedback to be provided to the user. For example, the controller 124 may determine to provide a type of feedback such as tactile, auditory, and / or visual feedback. In addition, in response to determining the type of feedback to be provided to the user, the controller 124 may determine the form of the feedback. For example, with respect to tactile feedback, the controller 124 may determine one or more of the intensity, duration, amplitude, frequency, and / or rhythm of the tactile feedback. With respect to auditory feedback, the controller 124 may determine one or more of the volume, sound, duration, amplitude, frequency, and / or rhythm of the auditory feedback. With respect to visual feedback, the controller 124 may determine one or more of the message, icon, shape, and / or appearance of the visual feedback.

[0069] In some embodiments, the type and form of feedback can be pre-selected and customized via user settings, user profiles, and / or provider settings, and the type and form of feedback can be customized within a medication regimen (e.g., an insulin regimen) and accommodate user preferences and / or capabilities.

[0070] In response to determining that feedback is to be provided to the user, the method 300 may include providing feedback via one or more feedback components 146 of the pen cap 104 and / or feedback components of the injection pen 102, such as Figure 3For example, the controller 124 may cause one or more feedback components 146 of the pen cap 104 to output a Figure 3 The feedback determined in action 306 of . As non-limiting examples, the controller 124 may cause one or more of a vibration motor, an audio transducer, or a display (eg, display screen 120 ) of the cap 104 and / or a feedback component of the injection pen 102 to output feedback.

[0071] As a non-limiting example, in an embodiment where one or more feedback components 146 of the cap 104 include a vibration motor, the controller 124 may cause the vibration motor to vibrate according to the determined feedback form. In an embodiment where one or more feedback components 146 of the cap 104 are audio transducers, the controller 124 may cause the audio transducer to output a sound according to the determined feedback form. In an embodiment where one or more feedback components 146 of the cap 104 are a display (e.g., display screen 120), the controller 124 may cause the display to display one or more messages, icons, lights, etc. according to the determined feedback form (e.g., visual appearance). Additionally, the controller 124 may cause the one or more feedback components 146 of the cap 104 to provide feedback via any combination of the above. In some embodiments, the controller 124 may further cause the feedback components of the injection pen 102 to provide feedback via any combination of the above. For example, the controller 124 may cause the feedback components 146 of the cap 104 to output two or more types of feedback (e.g., both tactile and auditory feedback, both tactile and visual feedback, and both auditory and visual feedback).

[0072] In some embodiments, the drug delivery device 100 (e.g., the pen cap 104) may transmit data to a client device 106 (e.g., a mobile device) with instructions for providing the determined feedback or one or more portions of the determined feedback. In one or more embodiments, the drug delivery device 100 (e.g., the pen cap 104) may transmit data to a client device 106 with instructions for providing the determined feedback in addition to or as an alternative to the feedback output by the drug delivery device 100.

[0073] Reference together Figures 1 to 3, the drug delivery device 100, one or more detectors 144, and one or more feedback components 146 described herein (hereinafter collectively referred to as "drug delivery device 100") can provide advantages over conventional delivery devices. For example, the drug delivery device 100 of the present disclosure can improve the user experience of using the drug delivery device 100 by providing confirmation (e.g., feedback) of correct actions (e.g., correct use) and notification (e.g., creating perception) of incorrect actions (e.g., incorrect use) when using the drug delivery device 100. As described above, the drug delivery device 100 can provide feedback through tactile feedback (e.g., vibration feedback), and the tactile feedback can create a more consistent user experience when inserting the injection pen 102 into the pen cap 104 and removing the injection pen 102 from the pen cap 104 compared to conventional delivery devices. In addition, a consistent user experience can reduce learning time and reduce user confusion compared to conventional delivery devices.

[0074] For example, users of conventional delivery devices may experience various challenges when operating the delivery devices. One challenge that users may experience when using conventional delivery devices is "diabetic fatigue syndrome" (DFS). As used herein, DFS can be defined as "a multifactorial syndrome of fatigue or fatigability occurring in diabetic patients," which can be caused by various factors. Accordingly, reducing learning barriers and reducing confusion when using the delivery device can reduce the cognitive burden on the user and can improve the user experience. Another challenge that users may experience is neuropathy. PWDs often suffer from nerve damage; accordingly, providing feedback via tactile feedback can benefit users with limited fine motor skills and dexterity. Similarly, tactile feedback can benefit users with hearing and / or visual impairments. In view of the foregoing, the drug delivery device 100 of the present disclosure can reduce the cognitive burden on the user by providing confirmation of correct actions and notification of incorrect actions (e.g., creating a perception).

[0075] Still refer to Figures 1 to 3 , any of the above feedbacks may occur in response to different interactions between the injection pen 102 and the pen cap 104. For example, when the injection pen 102 is inserted into the pen cap 104 after administering insulin, when a new injection pen 102 (e.g., an insulin pen) is inserted into the pen cap 104, when the correct injection pen 102 is inserted into the pen cap 104, when the injection pen 102 is incorrectly inserted into the pen cap 104, when the injection pen 102 is inserted into the pen cap 104 together with the needle and / or sheath, and / or when the injection pen 102 is removed from the pen cap 104, any of the above feedbacks may occur.

[0076] The feedback described herein can include vibrations of a specified duration, amplitude, frequency, and / or rhythm. In addition, the parameters of the feedback (e.g., tactile parameters) can depend on the medication regimen and / or the medication (e.g., the type of insulin) present in the injection pen 102 (e.g., present in a cartridge in the injection pen 102) and / or be customized based on the medication regimen and / or the medication present in the injection pen 102. The parameters of the feedback can be adjusted automatically and / or manually to address environmental and / or other challenges inherent to the user receiving the medication regimen (e.g., using a drug delivery device). For example, the parameters can depend on the user profile of the user and / or be customized based on the user profile of the user. For example, depending on the fine motor skills of the user, parameters such as the length and amplitude of the tactile feedback can be adjusted to accommodate user preferences and / or abilities.

[0077] Figure 4 4 is a block diagram of an exemplary computing device 400 that may be used as a client device (e.g., client device 106) or within and / or as a part of a drug delivery device 100 that may be configured to perform one or more of the above-described processes. It will be appreciated that one or more computing devices may implement computing device 400. Computing device 400 may include processor 402, memory 404, storage device 406, I / O interface 408, and communication interface 410, which may be communicatively coupled via communication infrastructure 412. Although Figure 4 An exemplary computing device is shown in FIG. Figure 4 The components shown in are not intended to be limiting. Additional or alternative components may be used in other embodiments. Furthermore, in some embodiments, computing device 400 may include more than Figure 4 The components shown in FIG. 1 are fewer than those shown in FIG. 1 . Figure 4 Components of computing device 400 are shown in .

[0078] In one or more embodiments, the processor 402 includes hardware for executing instructions, such as instructions that constitute a computer program. By way of example and not limitation, to execute instructions, the processor 402 may retrieve (or obtain) instructions from internal registers, internal caches, memory 404, or storage device 406, and decode and execute the instructions. In one or more embodiments, the processor 402 may include one or more internal caches for data, instructions, or addresses. By way of example and not limitation, the processor 402 may include one or more instruction caches, one or more data caches, and one or more translation lookaside buffers (TLBs). The instructions in the instruction cache may be copies of instructions in the memory 404 or storage device 406.

[0079] Memory 404 may be used to store data, metadata, and programs for execution by the processor(s). Memory 404 may include one or more of volatile and non-volatile memories, such as random access memory ("RAM"), read-only memory ("ROM"), solid state disk ("SSD"), flash memory, phase change memory ("PCM"), or other types of data storage devices. Memory 404 may be internal memory or distributed memory.

[0080] Storage device 406 includes a memory for storing data or instructions. As an example and not limitation, storage device 406 may include the above-mentioned non-transient storage medium. Storage device 406 may include a hard disk drive (HDD), a floppy disk drive, a flash memory, an optical disk, a magneto-optical disk, a tape or a universal serial bus (USB) drive or a combination of two or more of these. Where appropriate, storage device 406 may include a removable or non-removable (or fixed) medium. Storage device 406 may be inside or outside of computing device 400. In one or more embodiments, storage device 406 is a non-volatile solid-state memory. In other embodiments, storage device 406 includes a read-only memory (ROM). Where appropriate, the ROM may be a mask-programmed ROM, a programmable ROM (PROM), an erasable PROM (EPROM), an electrically erasable PROM (EEPROM), an electrically alterable ROM (EAROM) or a flash memory or a combination of two or more of these.

[0081] The I / O interface 408 allows a user to provide input to the computing device 400, receive output from the computing device 400, and otherwise transmit data to and receive data from the computing device 400. The I / O interface 408 may include a mouse, a keypad or keyboard, a touch screen, a camera, an optical scanner, a network interface, a modem, other known I / O devices, or a combination of such I / O interfaces. The I / O interface 408 may include one or more devices for presenting output to a user, including but not limited to a graphics engine, a display (e.g., a display screen), one or more output drivers (e.g., a display driver), one or more audio speakers, and one or more audio drivers. In some embodiments, the I / O interface 408 is configured to provide graphical data to the display for presentation to the user. The graphical data may represent one or more graphical user interfaces and / or any other graphical content that may serve a particular implementation.

[0082] Communication interface 410 may include hardware, software, or both. In any event, communication interface 410 may provide one or more interfaces for communication (such as, for example, packet-based communication) between computing device 400 and one or more other computing devices or networks. By way of example and not limitation, communication interface 410 may include a network interface controller (NIC) or network adapter for communicating with an Ethernet or other wired-based network, or a wireless NIC (WNIC) or wireless adapter for communicating with a wireless network such as WI-FI.

[0083] Additionally or alternatively, the communication interface 410 may facilitate communication with an ad hoc network, a personal area network (PAN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), or one or more portions of the Internet, or a combination of two or more of these. One or more portions of one or more of these networks may be wired or wireless. As an example, the communication interface 410 may facilitate communication with a wireless PAN (WPAN) such as, for example, WPAN), a WI-FI network, a WI-MAX network, a cellular telephone network (such as, for example, a Global System for Mobile Communications (GSM) network), or other suitable wireless networks, or a combination thereof.

[0084] Additionally, the communication interface 410 can facilitate communication of various communication protocols. Examples of communication protocols that can be used include, but are not limited to, data transmission media, communication devices, transmission control protocol ("TCP"), Internet protocol ("IP"), file transfer protocol ("FTP"), Telnet, hypertext transfer protocol ("HTTP"), secure hypertext transfer protocol ("HTTPS"), session initiation protocol ("SIP"), simple object access protocol ("SOAP"), extensible markup language ("XML") and its variants, simple mail transfer protocol ("SMTP"), real-time transport protocol ("RTP"), user datagram protocol ("UDP"), global system for mobile communications ("GSM") technology, code division multiple access ("CDMA") technology, time division multiple access ("TDMA") technology, short message service ("SMS"), time division multiple access ("TDMA") technology, short message service ("SMS"), multimedia message service ("MMS"), radio frequency ("RF") signaling technology, long term evolution ("LTE") technology, wireless communication technology, in-band and out-of-band signaling technology, and other suitable communication networks and technologies.

[0085] The communication infrastructure 412 may include hardware, software, or both that couples components of the computing device 400 to each other. By way of example and not limitation, the communication infrastructure 412 may include an accelerated graphics port (AGP) or other graphics bus, an enhanced industry standard architecture (EISA) bus, a front side bus (FSB), a HyperTransport (HT) interconnect, an industry standard architecture (ISA) bus, an InfiniBand interconnect, a low pin count (LPC) bus, a memory bus, a micro channel architecture (MCA) bus, a peripheral component interconnect (PCI) bus, a PCI-Express (PCIe) bus, a serial advanced technology attachment (SATA) bus, a video electronics standards association local (VLB) bus, or another suitable bus or combination thereof.

[0086] Embodiments of the present disclosure further include:

[0087] Embodiment 1. A method for providing feedback to a user of a drug delivery device, comprising: receiving information from one or more detectors of a pen cap of the drug delivery device, analyzing the received information to identify at least one of incorrect use or correct use of the drug delivery device, and in response to identifying one or more of the incorrect use or correct use, providing feedback via one or more feedback components of the pen cap of the drug delivery device.

[0088] Embodiment 2. The method of embodiment 1, wherein identifying at least one of improper use or proper use comprises identifying a physical interaction between a pen cap of the drug delivery device and the injection pen.

[0089] Embodiment 3. The method of embodiment 1 or 2, wherein identifying at least one of incorrect use or correct use comprises identifying a capping event between a pen cap of the drug delivery device and an injection pen of the drug delivery device.

[0090] Embodiment 4. The method of any one of embodiments 1-3, wherein identifying at least one of incorrect use or correct use comprises identifying an uncapping event between a pen cap of the drug delivery device and an injection pen of the drug delivery device.

[0091] Embodiment 5. The method of any one of embodiments 1-4, wherein identifying at least one of improper use or proper use comprises identifying insertion of a new injection pen into a pen cap of a drug delivery device.

[0092] Embodiment 6. The method of any one of embodiments 1-5, wherein identifying at least one of incorrect use or correct use comprises identifying that an injection pen of the drug delivery device is not fully inserted into a pen cap of the drug delivery device.

[0093] Embodiment 7. The method of any one of embodiments 1-6, wherein identifying at least one of incorrect use or correct use comprises identifying that the injection pen of the drug delivery device is fully inserted into the pen cap of the drug delivery device.

[0094] Embodiment 8. The method of any one of embodiments 1-7, wherein identifying at least one of improper use or correct use comprises identifying an injection pen having at least one of a needle or a sheath of the drug delivery device inserted into a pen cap of the drug delivery device.

[0095] Embodiment 9. The method of any of Embodiments 1-8, wherein receiving information from one or more detectors of a pen cap of the drug delivery device comprises receiving information from an injection pen entry detector.

[0096] Embodiment 10. The method according to embodiment 9, wherein receiving information from the injection pen entry detector comprises receiving information about the injection pen being entered into the pen cap or the injection pen being removed from the pen cap.

[0097] Embodiment 11. The method of any of Embodiments 1-10, wherein receiving information from one or more detectors of a pen cap of the drug delivery device comprises receiving information from an injection pen insertion level detector.

[0098] Embodiment 12. The method of embodiment 11, wherein receiving information from the injection pen insertion level detector comprises receiving information about a proximity of an end of the injection pen to an end of the pen cap opposite to the opening of the pen cap.

[0099] Embodiment 13. The method of any of Embodiments 1-12, wherein receiving information from one or more detectors of a pen cap of a drug delivery device comprises receiving information from an injection pen tension detector.

[0100] Embodiment 14. The method of embodiment 13, wherein receiving information from the injection pen tension detector comprises receiving information about an amount of force experienced by the injection pen in a direction parallel to a longitudinal axis of the pen cap.

[0101] Embodiment 15. The method of any of Embodiments 1-14, wherein receiving information from one or more detectors of a pen cap of the drug delivery device comprises receiving information from a fastening force detector.

[0102] Embodiment 16. The method of Embodiment 15, wherein receiving information from the fastening force detector comprises receiving information about an amount of force applied by the pen cap on the injection pen.

[0103] Embodiment 17. A drug delivery device, comprising: an injection pen; and a pen cap, the pen cap comprising: one or more detectors; a vibration motor; and a controller, the controller comprising: at least one processor; and at least one non-transitory computer-readable storage medium storing instructions thereon, the instructions, when executed by the at least one processor, causing the controller to: receive information about physical interaction between the pen cap and the injection pen from one or more detectors of the pen cap; analyze the received information to identify at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen; and provide feedback via the vibration motor of the drug delivery device in response to identifying at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen.

[0104] Embodiment 18. The drug delivery device of Embodiment 17, wherein the one or more detectors of the pen cap include one or more of a pen entry detector, a pen insertion level detector, a pen tension detector, or a fastening force detector.

[0105] Embodiment 19. A drug delivery device according to any one of embodiments 17 or 18, further comprising instructions which, when executed by at least one processor, cause the controller to: identify at least one of an incorrect dosing action or a correct dosing action; and provide feedback via a vibration motor of the drug delivery device in response to identifying at least one of an incorrect dosing action or a correct dosing action.

[0106] Embodiment 20. A non-transitory computer-readable storage medium storing instructions thereon, which, when executed by at least one processor, causes the at least one processor to perform steps including: receiving information about physical interactions between a pen cap and an injection pen of a drug delivery device; analyzing the received information to identify at least one incorrect physical interaction between the pen cap and the injection pen; and providing tactile feedback via the pen cap in response to identifying at least one incorrect physical interaction.

[0107] The exemplary embodiments of the present disclosure described above and illustrated in the accompanying drawings do not limit the scope of the present invention, as these embodiments are merely examples of embodiments of the present invention, and the scope of the present invention is defined by the appended claims and their legal equivalents. Any equivalent embodiments are intended to fall within the scope of the present invention. In fact, in addition to the various modifications shown and described herein, various modifications of the present disclosure such as alternative useful combinations of the described content features may become apparent to those skilled in the art from the description. Such modifications and embodiments are also intended to fall within the scope of the appended claims and legal equivalents.

Claims

1. A method of providing feedback to a user of a drug delivery device, comprising: receiving information from a detector of a pen cap of the drug delivery device; analyzing the received information to identify at least one of an improper use of the drug delivery device or a proper use of the drug delivery device; as well as In response to identifying the at least one of incorrect use or correct use, feedback is provided via at least one feedback component of the pen cap of the drug delivery device.

2. The method according to claim 1, characterized in that Identifying at least one of improper use or proper use includes identifying a physical interaction between the pen cap and an injection pen of the drug delivery device.

3. The method according to claim 1, characterized in that Identifying at least one of improper use or proper use includes identifying a capping event between the pen cap of the drug delivery device and an injection pen of the drug delivery device.

4. The method according to claim 1, characterized in that: Identifying at least one of improper use or proper use includes identifying a decapping event between the pen cap of the drug delivery device and an injection pen of the drug delivery device.

5. The method according to claim 1, characterized in that Identifying at least one of improper use or proper use includes identifying insertion of a new injection pen into the pen cap of the drug delivery device.

6. The method according to claim 1, characterized in that At least one of identifying improper use or correct use includes identifying that an injection pen of the drug delivery device is not fully inserted into the pen cap of the drug delivery device.

7. The method according to claim 1, characterized in that Identifying at least one of improper use or correct use includes identifying that an injection pen of the drug delivery device is fully inserted into the pen cap of the drug delivery device.

8. The method according to claim 1, characterized in that Identifying at least one of improper use or correct use includes identifying an injection pen having at least one of a needle or a sheath of the drug delivery device inserted into the pen cap of the drug delivery device.

9. The method according to claim 1, characterized in that: Receiving information from a detector of the pen cap of the drug delivery device includes receiving information from a pen entry detector.

10. The method according to claim 9, characterized in that Receiving information from the injection pen entry detector includes receiving information about the injection pen being entered into the pen cap or the injection pen being removed from the pen cap.

11. The method according to claim 1, characterized in that: Receiving information from a detector of the pen cap of the drug delivery device includes receiving information from an injection pen insertion level detector.

12. The method according to claim 11, characterized in that Receiving information from the injection pen insertion level detector includes receiving information regarding proximity of an end of the injection pen to an end of the pen cap opposite to an opening of the pen cap.

13. The method according to claim 1, characterized in that Receiving information from a detector of the pen cap of the drug delivery device includes receiving information from an injection pen tension detector.

14. The method according to claim 13, characterized in that Receiving information from the injection pen tension detector comprises receiving information about an amount of force experienced by the injection pen in a direction parallel to a longitudinal axis of the pen cap.

15. The method according to claim 1, characterized in that Receiving information from a detector of the pen cap of the drug delivery device includes receiving information from a fastening force detector.

16. The method according to claim 15, characterized in that Receiving information from the fastening force detector includes receiving information about an amount of force exerted by the pen cap on the injection pen.

17. A drug delivery device comprising: Injection pen; as well as A pen cap, comprising: one or more detectors; Vibration motor; and A controller, the controller comprising: at least one processor; and at least one non-transitory computer-readable storage medium having stored thereon instructions that, when executed by the at least one processor, cause the controller to: receiving information about physical interactions between the pen cap and the injection pen from the one or more detectors of the pen cap; analyzing the received information to identify at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen; and In response to identifying the at least one of an incorrect physical interaction or a correct physical interaction between the pen cap and the injection pen, providing feedback via the vibration motor of the drug delivery device.

18. The drug delivery device according to claim 17, characterized in that The one or more detectors of the pen cap include one or more of a pen entry detector, a pen insertion level detector, a pen tension detector, or a fastening force detector.

19. The drug delivery device of claim 17, further comprising instructions that, when executed by the at least one processor, cause the controller to: identifying at least one of an incorrect dosing action or a correct dosing action; and In response to identifying the at least one of an incorrect dosing action or a correct dosing action, providing feedback via the vibration motor of the drug delivery device.

20. A non-transitory computer-readable storage medium having instructions stored thereon, which, when executed by at least one processor, cause the at least one processor to perform steps comprising: receiving information regarding a physical interaction between a pen cap of a drug delivery device and an injection pen; analyzing the received information to identify at least one improper physical interaction between the pen cap and the injection pen; and In response to identifying the at least one incorrect physical interaction, tactile feedback is provided via the pen cap.

Images