Drug delivery system, method for providing feedback related to use of a drug delivery system, and method for detecting use of a drug delivery system - Patent Application 20070122997

Abstract

The present invention relates to a drug delivery system, a method for providing feedback related to use of the drug delivery system, and a method for detecting use of the drug delivery system. The drug delivery device includes an injection pen and a pen cap. The pen cap includes one or more detectors, a vibration motor, and a controller. The controller is configured to receive information from the one or more detectors in the pen cap regarding a physical interaction between the pen cap and the syringe, 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 syringe, and provide feedback via the vibration motor of the drug delivery device in response to identifying at least one of the incorrect physical interaction or the correct physical interaction between the pen cap and the syringe.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 367,443, filed June 30, 2022, for "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 this reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure generally relates to drug delivery systems and methods that improve drug therapy management by providing confirmation of correct use of a drug delivery device and generating awareness of incorrect use of a drug delivery device. [Background technology]

[0003] Drug delivery pens are commonly utilized to deliver a variety of therapeutic agents for a number of different medical treatments, often including one or more regimens of growth hormone, insulin, fertility medications, Homozygous Familial Hypercholesterolemia (HoFH) treatment, etc.

[0004] With regard to insulin therapy, diabetes mellitus is a chronic metabolic disorder caused by the inability of a person's pancreas to produce sufficient amounts of the hormone insulin, thereby preventing the person's metabolism from properly absorbing sugars and starches. This can result in hyperglycemia or hypoglycemia. Hyperglycemia refers to the presence of excessive amounts of glucose in the blood plasma. Persistent hyperglycemia is associated with a variety of serious 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 limb amputation. Hypoglycemia is a condition in which glucose levels are lower than the normal range. Hypoglycemia is associated with a variety of symptoms, such as clumsiness, difficulty speaking, confusion, and life-threatening long-term complications, such as loss of consciousness, seizures, or death. Because a cure is not yet possible, permanent treatment is required to provide consistent glycemic control, which is achieved by periodically delivering an exogenous drug to the patient's body, thereby lowering elevated blood glucose levels, in order to maintain blood glucose levels consistently within the normal range.

[0005] Permanent treatment is often required to maintain adequate blood glucose levels within the normal range. Maintaining adequate glucose levels is achieved by providing a person with diabetes (PWD) with regular insulin. Maintaining adequate blood glucose levels poses a significant cognitive burden for PWD, affecting many aspects of their lives. For example, cognitive burden on PWDs can result from, among other things, tracking meals and regularly checking and slightly correcting blood glucose levels. Regulating blood glucose levels by PWDs may involve taking insulin, administering insulin and tracking glucose, as well as determining the amount of insulin to take, how often to take insulin, where to inject insulin, and when to administer insulin relative to meals and / or glucose fluctuations. The aforementioned factors constitute only a small portion of the significant cognitive burden on PWDs.

[0006] The following example of a typical daily routine for a PWD further illustrates the significant cognitive burden of PWD: In the morning, a PWD's first thoughts / actions are often related to their glucose, such as what their blood glucose level is. What were the PWD's blood glucose levels overnight? And how does the PWD feel now? Checking the PWD's blood glucose levels (e.g., using a blood glucose meter or monitor) often leads the PWD to consider what action to take, such as adjusting the PWD's morning activities, changing when or what they eat for breakfast, or deciding to take rapid-acting (RA) insulin and where to inject the RA insulin.

[0007] Before the PWD eats breakfast (or any meal), the PWD thinks about the amount and type of food they plan to eat and possibly alters their RA insulin dose based on the carbohydrate content of the foods they choose to eat. Before the PWD administers their RA insulin, the PWD tries to remember when they took their last dose of insulin, what happened the last time they ate a particular meal, and how they felt.

[0008] Before leaving home, PWDs consider whether they have sufficient supplies for glucose monitoring or insulin dosing, among other things, which may include batteries, charging devices, backup supplies, glucose testing supplies, and insulin supplies to treat high blood glucose levels. Additionally, because exercise can lower blood glucose more than expected, PWDs should consider any physical activity that affects glucose (e.g., children walking to school, going to the gym, riding a bicycle). Even before driving a car, PWDs should check their glucose to determine if it is at a safe level for driving.

[0009] As lunchtime approaches, PWDs consider their glucose prior to eating lunch, for example, what time they expect to eat, and what they expect to eat throughout the day. Thus, PWDs mentally tally carbohydrates and adjust insulin doses. PWDs also consider which insulin doses they have taken recently and whether those doses are still working to lower blood glucose. This is all done in parallel with what PWDs are doing in their busy daily lives, so they often forget or don't consider all of the above factors at all.

[0010] Throughout the day, PWDs often check their glucose levels, especially on days when their activities differ from their typical days. This constant thinking, checking, and planning can be exhausting, especially when each check requires decisions, calculations, and possible behavioral changes. Additionally, during the day, PWDs may check supply inventory, speak with health care providers (HCPs), refill prescriptions, and contact health plans to discuss treatment and / or supplies.

[0011] In the evening, the PWD may have to take their daily insulin dose of long-acting (LA) insulin. Additionally, the PWD may determine whether their glucose is stable before going to sleep. If the PWD uses an infusion pump, they must check if their insulin pump is low on insulin and needs to be refilled before sleep. If they have a continuous glucose monitor, they must check if it is working. Even then, based on what the PWD ate for dinner, nighttime insulin may not be able to keep the PWD's glucose stable. Nighttime glucose levels can not only disrupt sleep, but can also add to anxiety, which can interfere with sleep.

[0012] Therefore, managing diabetes requires significant attention to detail throughout the day. Even with careful planning and self-monitoring, PWDs may skip doses, take double doses, or take the wrong amount and / or type of insulin. Insufficient insulin can result in hyperglycemia, and too much insulin can result in hypoglycemia, which can lead to clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death.

[0013] To assist with self-treatment, some diabetes treatment devices (e.g., without limitation, blood glucose meters, insulin pumps) include an insulin bolus calculator that allows the user to input an estimate (e.g., a numerical estimate) of the amount of carbohydrates consumed or to be consumed (or additionally or alternatively, protein, fat, or other dietary data), and the bolus calculator outputs a recommended size of an insulin bolus dosage. Although bolus calculators somewhat reduce the mental calculations performed by users in determining appropriate insulin bolus dosages, bolus calculators still burden users with the mental task of evaluating the components of a PWD's meal, may require the use of a secondary device, and often require manual entry of data.

[0014] Although conventional medication dispensing systems may reduce some of the mental burden on PWDs in determining appropriate recommendations related to insulin dosing, medication dispensing systems still burden PWDs with one or more of the following mental tasks: 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 benefit and / or solve one or more of the above-referenced or other problems in the art using systems and methods for utilizing drug delivery devices. Embodiments include a method for providing feedback to a user of a medication delivery device. The method includes receiving information from one or more detectors of a pen cap of a medication delivery device, analyzing the received information to identify at least one incorrect or correct use of the medication delivery device, and providing feedback via one or more feedback components of the pen cap of the medication delivery device in response to identifying one or more of the incorrect use or correct use.

[0016] Some embodiments include a drug delivery device. The medication delivery device may include an injection pen and a pen cap, which may include one or more detectors, a vibration motor, and a controller.

[0017] The controller may include at least one processor and at least one non-transitory computer-readable storage medium storing instructions that, when executed by the at least one processor, cause the controller to: receive information regarding a physical interaction between the pen cap and the injection pen from one or more detectors in 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 a vibration motor of the medication 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.

[0018] One or more embodiments include a non-transitory computer-readable medium storing instructions that, when executed by at least one processor, cause the at least one processor to perform steps including receiving information regarding a physical interaction between a pen cap of a medication delivery device and an injection pen; analyzing the received information to identify at least one erroneous physical interaction between the pen cap and the injection pen; and providing tactile feedback via the pen cap in response to identifying the at least one erroneous physical interaction. Various embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of a medication delivery device according to one or more embodiments. [Figure 2] 2 is a schematic diagram of the drug delivery device of FIG. 1 according to one or more embodiments. [Figure 3] 1 is a flow diagram of a method for providing feedback to a user regarding use of a medication delivery device according to one or more embodiments. [Figure 4] FIG. 1 is a block diagram of an exemplary computing device according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0020] The diagrams presented herein are not actual diagrams of any particular drug delivery device or any of its components, but are merely idealized representations used for purposes of explaining the present invention. As used herein, the singular forms following "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0021] As used herein, the term "may" in reference to a material, structure, feature, function, or method action indicates that it is contemplated for use in the implementation of one embodiment of the present disclosure, and such term is used in preference to the limiting term "is" to avoid any suggestion that other compatible materials, structures, features, functions, and methods that can be used in combination therewith are or must be excluded. As used herein, the use of "first," "second," and any related terms is used for clarity and convenience in understanding this disclosure and the accompanying drawings, and no particular preference or order is implied or relied upon unless the context clearly dictates otherwise. As used herein, the term "substantially" with respect to a given parameter, characteristic, operation, or condition includes the extent to which one of ordinary skill in the art would understand that the given parameter, characteristic, or condition is met with minor variations, such as within acceptable manufacturing tolerances. By way of example, depending on the particular parameter, characteristic, or condition that is substantially met, the parameter, characteristic, or condition may be at least 90.0% met, at least 95.0% met, at least 99.0% met, or at least 99.9% met. As used herein, the term "about" when used in 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 the measurement of the given parameter, as well as variations resulting from manufacturing tolerances, etc.).

[0022] Embodiments of the present disclosure include a medication delivery device having one or more detectors (e.g., sensors) that detect interaction between the pen cap of the medication delivery device and an injection pen (e.g., an insulin pen) of the medication delivery device and / or that detect interaction between the medication delivery device and a user (e.g., a medication administration action).

[0023] Additionally, the medication delivery device includes one or more feedback components (e.g., tactile, visual, and / or audio feedback components) for providing feedback to the user regarding the interaction between the pen cap and the injection pen and / or the interaction between the medication delivery device and the user. For example, embodiments of the present disclosure include providing feedback via one or more feedback components in response to an injection pen being inserted into the pen cap after administering a therapeutic agent, a new injection pen (e.g., an insulin pen) being inserted into the pen cap, a correct injection pen being inserted into the pen cap, an incorrect insertion of an injection pen into the pen cap, an injection pen being inserted into the pen cap with a needle and / or sheath, and / or an injection pen being removed from the pen cap.

[0024] Additionally, the feedback may be indicated, for example, via feedback duration, amplitude, frequency, and / or rhythm, correct and / or incorrect interactions. For example, feedback may be specific to correct and / or incorrect interactions.

[0025] Thus, the medication delivery devices described herein may provide advantages over conventional delivery devices. For example, the medication delivery devices of the present disclosure may improve the user experience when utilizing the medication delivery device by providing confirmation (e.g., feedback) of correct behavior (e.g., correct use) and notification (e.g., creating awareness) of incorrect behavior (e.g., incorrect use) when utilizing the medication delivery device.

[0026] As a non-limiting example, the medication delivery device may provide feedback through tactile feedback (e.g., vibration feedback), which may create a consistent user experience when inserting and removing the injection pen into and from the pen cap compared to conventional delivery devices. Furthermore, the consistent user experience may reduce learning time and reduce user confusion compared to conventional delivery devices.

[0027] For example, users of conventional delivery devices may experience various challenges when operating the delivery device. One challenge that users may experience when using conventional delivery devices is "diabetes fatigue syndrome" (DFS). As used herein, DFS may be defined as a "multifactorial syndrome of fatigue or easy fatigability occurring in diabetic patients" that may be caused by a variety of factors. Therefore, reducing learning disabilities and reducing confusion when using a delivery device can reduce the user's cognitive burden and improve the user experience. Another challenge that users may experience is neurological impairment. PWDs often have nerve damage, and therefore providing feedback via tactile feedback can be beneficial to users with limited fine motor skills and dexterity. Similarly, tactile feedback can be beneficial to users with hearing and / or visual impairments. In light of the above, the drug delivery device of the present disclosure can reduce the user's cognitive burden by providing confirmation of correct actions and notification of incorrect actions (e.g., creating awareness).

[0028] Embodiments of the present disclosure include providing tactile feedback that includes vibrations of a specified duration, amplitude, frequency, and / or rhythm. Additionally, the feedback parameters (e.g., tactile parameters) may depend on and / or be customized based on the drug treatment regimen and / or the therapeutic agent (e.g., type of insulin) present in the injection pen (e.g., present in a cartridge within the injection pen). The parameters of the feedback may be adjusted automatically and / or manually to address environmental and / or other challenges specific to a user undergoing a drug treatment regimen (e.g., utilizing a drug delivery device). For example, the parameters may be dependent on and / or customized based on a user profile of the user. For example, depending on the user's fine motor skills, parameters such as the length and amplitude of the haptic feedback may be adjusted to accommodate the user's preferences and / or abilities.

[0029] FIG. 1 is a perspective view of a medication delivery device 100 according to one or more embodiments of the present disclosure.

[0030] As shown in FIG. 1, in some embodiments, a medication delivery device 100 may include an injection pen 102 (eg, an insulin pen) and a pen cap 104. In some embodiments, the medication delivery device 100 may include one or more of a quick acting insulin (QAI) pen or a long acting insulin (LAI) pen.

[0031] As described in more detail below, the pen cap 104 may wirelessly communicate with one or more of the client device 106, the application 108 on the client device 106, the glucose monitor 110, and / or external systems / resources 114 via one or more networks 105.

[0032] In some embodiments, the application 108 (e.g., a tools application) of the client device 106 may include a drug therapy management system that enables a user to manage their drug therapy and at least partially control and / or configure the drug delivery device 100 (e.g., adjust settings of the drug delivery device 100).

[0033] As a non-limiting example, the application 108 may be directed to assisting a user in managing their insulin therapy. In some cases, the application 108 may be a web application for managing a user's insulin therapy. In some embodiments, the application 108 may be local to the client device 106 .

[0034] 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 medication delivery device 100 .

[0035] In some embodiments, client device 106 may execute one or more applications (e.g., application 108) to implement the functionality of the various embodiments and processes described herein.

[0036] 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 running on a mobile device, such as a smartphone or tablet.

[0037] The application 108 may be native to the operating system of the client device 106 . Further, in some embodiments, the application 108 may be a client application that is associated with the drug therapy management system and / or at least a portion of the drug delivery device 100 (e.g., the pen cap 104 of the drug delivery device 100) and configured to be able to interact directly with the drug therapy management system through the application 108.

[0038] The client device 106 , the glucose monitor 110 , one or more external systems / resources 114 , and the medication delivery device 100 may communicate via one or more networks 105 .

[0039] In one or more embodiments, the one or more networks 105 may include a combination of a cellular or mobile communications network, a public switched telephone network (PSTN), and / or the Internet or World Wide Web that facilitates the transmission of data between the client device 106 (e.g., the injection site determination system 106), the glucose monitor 110, one or more external systems / resources 114, and the drug delivery device 100. However, network 105 may include a variety of other types of networks using different communication technologies and protocols, such as a wireless local 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.

[0040] In additional embodiments, the client device 106, the glucose monitor 110, one or more external systems / resources 114, and the medication delivery device 100 may communicate via Bluetooth and near field communication in addition to or instead of one or more networks 105.

[0041] 1 illustrates a particular arrangement of the client device 106, the glucose monitor 110, the one or more external systems / resources 114, the one or more networks 105, and the drug delivery device 100. For example, the drug delivery device 100, the glucose monitor 110, and / or the one or more external systems / resources 114 may communicate directly with the client device 106, bypassing the network 105. A user may interface with the client device 106 to utilize the drug therapy management system, for example, to enter user preferences, adjust profiles, view notifications, interact with providers, adjust settings on the drug delivery device 100, etc.

[0042] The client devices 106 may be any one or more of various types of computing devices. For example, the client devices 106 may include mobile devices such as mobile phones, smartphones, PDAs, tablets, or laptops, or non-mobile devices such as desktops or other types of computing devices. Further details regarding the client devices 106 are described below with respect to FIG. 4.

[0043] The external systems / resources 114 may include additional systems that interface with the client device 106, the application 108, the drug therapy management system, and / or the drug delivery device. The external systems / resources 114 may, in some embodiments, include additional medical devices.

[0044] Medical devices may include additional insulin delivery systems, including, but not limited to, insulin delivery devices (e.g., infusion pumps, injection pens, and inhalers), glucose sensors (e.g., CGMs and blood glucose meters), therapy managers (e.g., controllers for controlling open-loop and closed-loop delivery of insulin or aspects of insulin delivery, and recommendation systems for providing therapy recommendations to users and / or healthcare providers), and combinations thereof.

[0045] In some embodiments, external systems / resources 114 may include subject matter expert input data, clinical literature, conventional therapeutic regimens, and the like. The external systems / resources 114 may, in various embodiments, include a treatment management system.

[0046] The therapy management system may include a diabetes management system that monitors blood glucose data and therapy data and manages therapy settings. In further embodiments, the external systems / resources 114 may include healthcare provider devices. In additional embodiments, the external systems / resources 114 may include a cloud computing platform and / or one or more servers. Additionally, the drug therapy management system may run at least in part on external systems / resources 114 .

[0047] In some embodiments, glucose monitor 110 may include any known glucose monitor, for example, one or more of a continuous glucose monitor (CGM), a flash glucose monitor, a blood glucose meter (BGM), or any other suitable sensor. In the case of CGMs and flash glucose monitors, the CGMs and flash glucose monitors may provide glucose data based on the user's interstitial fluid glucose levels, which may be correlated to blood glucose levels. BGMs may be configured to provide blood glucose data typically based on blood samples. Thus, the term "blood glucose" is not limited to use solely with blood glucose data, values, levels, etc., but also includes interstitial fluid glucose levels, as well as any intermediate measurements.

[0048] Figure 2 is a schematic diagram of the medication delivery device 100 of Figure 1, including a pen cap 104 and an injection pen 102. Referring jointly to Figures 1 and 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 a 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., and one or more indicator lights 122 that may illuminate to indicate that data is being transferred, illuminate to indicate that user attention is required, and / or illuminate to indicate whether a dosage capture function is activated.

[0049] Additionally, the pen cap 104 may utilize the display screen 120 to display one or more of the estimated glucose value (EVG), units of EVG, a trend indicator for EVG, a recommended dosage, an identification of the insulin type, a recommended site of injection, the time and amount of the previous dose, and / or an insulin on-board value to remind the user of their most recent dose. In some embodiments, the display screen 120 of the pen cap 104 may include a touchscreen, which may include one or more inputs 116 and / or one or more inputs 118 . Additionally, the pen cap 104 itself may include dosage capture technology.

[0050] With continued reference to FIGS. 1 and 2 together, the pen cap 104 may include a controller 124 that includes a processor 126, a data storage device 128 (or memory), and a communication subsystem 130.

[0051] The communication subsystem 130 may enable wireless communication between the pen cap 104 and the client device 106 and / or glucose monitor 110. In some cases, the communication subsystem 130 may include a near field communication (NFC) chip. In some cases, the communication subsystem 130 may include a Bluetooth Low Energy (BLE) chip. In some cases, the communication subsystem 130 may include optical communication devices, infrared communication devices, wireless communication devices (such as antennas), and / or chipsets (e.g., Bluetooth devices (e.g., Bluetooth Low Energy, Classic Bluetooth, etc.), near field communication (NFC) devices, 802.6 devices (e.g., metropolitan area networks (MANs), Zigbee devices, etc.), WiFi devices, WiMax devices, cellular communication facilities, etc.). In these and other cases, the communications subsystem 130 may exchange data with a network and / or any other device or system described in this disclosure.

[0052] Additionally, in some embodiments, the pen cap 104 may include a power source 132, which may include a rechargeable or non-rechargeable battery. Additionally, the pen cap 104 may include a pen-type detector 134 , a microswitch 136 , an optical sensor 138 , and a position sensor 140 . In one or more embodiments, the controller 124 may determine the pen type from data from the pen type detector 134 . The controller 124 may also use one or more of the microswitch 136, the optical sensor 138, and the position sensor 140 to determine the position of the plunger 142 in the injection pen 102. Based on the determined position of the plunger 142, a dosing event and / or the amount of insulin to be delivered may be determined by the controller 124.

[0053] Additionally, the pen cap 104 may include one or more sensors / detectors 144 (hereinafter referred to as "one or more detectors 144") operably coupled to the controller 124 for determining and identifying 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 insertion detector, an injection pen insertion level detector, an injection pen pull force detector, an accelerometer, a temperature sensor, or a grip force detector.

[0054] The injection pen insertion detector may be located in an opening in the pen cap 104 configured to receive the injection pen 102 . In some embodiments, the injection pen insertion 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 insertion detector may include a non-contact sensor. The injection pen insertion detector may be utilized to detect the insertion and / or removal of the injection pen 102 and to provide information (e.g., data) to the controller 124 regarding whether the injection pen 102 is inserted into and / or removed from the pen cap 104. In some embodiments, the proximity sensors may include one or more of optical proximity sensors, acoustic proximity sensors, magnetic proximity sensors, and / or capacitive proximity sensors. Further, the infrared sensors may include one or more of transmissive or reflective infrared sensors.

[0055] The image sensor may include one or more of a charge coupled device sensor or a CMOS image sensor.

[0056] The injection pen insertion level detector may be located proximate to the end (e.g., bottom) of the pen cap 104 opposite 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 utilized to detect when the injection pen 102 reaches the end of the pen cap 104 opposite the opening of the pen cap 104 and to provide information (e.g., data) to the controller 124 regarding 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 the opening of the pen cap 104 (e.g., fully inserted into the pen cap 104).

[0057] The proximity sensor may include any of the proximity sensors described above. The force sensor may include one or more of a load cell, a strain gauge, a pressure sensor, or any other known force sensor.

[0058] The injection pen tensile force detector may be located within one or more portions (e.g., gripping, radial bump, frictional gripping) of the pen cap 104 configured to couple (e.g., grip, engage, etc.) the injection pen 102 via mechanical force when the injection pen 102 is placed within the pen cap 104. In one or more embodiments, the injection pen pull force detector may include a force sensor.

[0059] The injection pen pull force detector may be utilized to determine the amount of force that the injection pen 102 is experiencing at a given moment and to provide information (e.g., data) to the controller 124 regarding the force that the injection pen 102 is experiencing. In some embodiments, the injector pen pull force detector may be configured to determine the amount of force that the injector pen 102 is experiencing in a direction parallel to the longitudinal axis of the pen cap 104 .

[0060] The force sensor may include any of the force sensors described above. In some embodiments, data from the injection pen pull force detector may be utilized as a safety mechanism to allow the user to remove the injection pen 102 from the pen cap 104 with the gripping mechanism in an engaged state (i.e., gripping mechanism malfunction).

[0061] The grip force detector may be located within one or more portions of the pen cap 104 that are configured to couple (e.g., grip, engage, etc.) the injection pen 102 via mechanical force when the injection pen 102 is placed within the pen cap 104. In one or more embodiments, the grip force detector may include a force sensor. The grip force detector may be utilized to determine the amount of force that the pen cap 104 is applying to the injection pen 102 at a given moment and to provide information (e.g., data) to the controller 124 regarding the force being applied to the injection pen 102. In some embodiments, the gripping force detector may be configured to determine the amount and direction of force that the pen cap 104 (e.g., a gripping mechanism of the pen cap 104) is applying to the injection pen 102. The force sensor may include any of the force sensors described above.

[0062] The accelerometer may be located in any portion of the pen cap 104 . The accelerometer may be utilized to identify the movement and / or orientation of the pen cap 104 and to provide information (eg, data) regarding the movement and / or orientation of the pen cap 104 to the controller. Information received from the accelerometer may be utilized in the operation of the pen cap 104 wake-up functions, sleep modes, and power consumption.

[0063] The temperature sensor may be located in any portion of the pen cap 104 . The temperature sensor may be utilized to monitor the temperature of the pen cap 104, the injection pen 102, or both, and to provide information (eg, data) regarding the temperature sensor of the pen cap 104 to the controller. Information received from the temperature sensor may be used to determine the viability of therapeutic drugs, optimize battery charging, and determine usage patterns.

[0064] With continued reference to Figures 1 and 2, the pen cap 104 may further include one or more feedback components 146 for providing feedback to the user.

[0065] One or more feedback components 146 may be disposed in or on any portion of the pen 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 (eg, a solenoid), an audio transducer, or a display (eg, the display screen 120).

[0066] As described in more detail below, the feedback component 146 may be utilized to provide feedback to the user to indicate correct user interaction with the pen cap 104, the proper state of the pen cap 104, the correct interaction between the pen cap 104 and the injection pen 102 (e.g., correct insertion of the injection pen 102 into the pen cap 104), and / or the correct orientation of the pen cap 104 relative to the injection pen 102, and / or to indicate incorrect user interaction with the pen cap 104, the improper state of the pen cap 104, the incorrect interaction between the pen cap 104 and the injection pen 102 (e.g., incorrect insertion of the injection pen 102 into the pen cap 104), and / or the incorrect orientation of the pen cap 104 relative to the injection pen 102. Additionally, the feedback component 146 may be utilized to provide feedback to the user regarding continuous glucose monitor or blood glucose meter scans, battery level, temperature, drug viability in the injection pen 102, incorrect injection pen insertion, and / or insertion of a foreign object.

[0067] The vibration motor may include any conventional vibration motor (eg, a haptic solenoid) and may be configured to provide haptic feedback to the user. In some embodiments, the vibration motor may include a designated motor. In additional embodiments, the vibration motor may be part of another element of the pen cap 104, such as an actuation motor for another operation of the pen cap 104.

[0068] The audio transducer may include one or more of an audio speaker or a piezoelectric transducer.

[0069] The display may include any conventional display for providing (eg, 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.

[0070] FIG. 3 shows a flow diagram of a method 300 for providing feedback to a user regarding the use of a medication delivery device.

[0071] 1-3, method 300 may include receiving information (eg, data) from one or more sensors / detectors 144, as shown at operation 302 in FIG.

[0072] For example, the controller 124 may receive information from one or more of an injection pen insertion detector, an injection pen insertion level detector, an injection pen pull force detector, an accelerometer, a temperature sensor, or a grip force detector, such as any of the detectors 144 described above. In some embodiments, the controller 124 may receive 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 . 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 interaction with one or more of the injection pen 102 or pen cap 104 (e.g., one or more of the detectors 144 that detect the user interaction).

[0073] The user interaction may include one or more of a user inserting the injection pen 102 into the pen cap 104 (e.g., a cap installation event), a user removing the injection pen 102 from the pen cap 104 (e.g., a cap removal event), or a medication dispensing action or event. The dispensing actions and events may include any of the dispensing actions and events described in U.S. patent application Ser. No. 16 / 442,281 to Bowland et al., filed June 14, 2019, and / or U.S. Patent No. 11,154,660 to Sjolund et al., filed December 12, 2018, the disclosures of which are incorporated herein by reference in their entireties.

[0074] In some embodiments, the controller 124 may receive information in response to the amount of time that has elapsed since a user interaction (eg, an event). In one or more embodiments, the controller 124 may receive information in response to the measured temperature. In some embodiments, the controller 124 may receive the information continuously.

[0075] In one or more embodiments, the information received from the detector 144 may include one or more of an indication of the insertion and / or removal of the injection pen 102 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 the injection pen 102 is experiencing at a given moment and an indication of the amount of force the pen cap 104 is applying to the injection pen 102 at a given moment, an indication of the movement and / or direction of the pen cap 104, and / or an indication of the temperature of the pen cap 104.

[0076] In response to receiving information (eg, data) from one or more sensors / detectors 144, method 300 may include analyzing the information, as shown in operation 304 of FIG. 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 client device 106 may analyze the received information. In some embodiments, analyzing the received information may include identifying correct and / or incorrect use of the injection pen 102 and / or pen cap 104 .

[0077] 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 therapeutic agent via the injection pen 102 and pen cap 104, or any other use of a pen cap or injection pen that is typical when administering a drug (e.g., insulin) therapy. Additionally, "use" can refer to the insertion of the injection pen 102 into the pen cap 104 after administering a therapeutic agent, the insertion of a new injection pen into the pen cap 104, and the insertion of the injection pen 102 with or without a needle and / or sheath into the pen cap 104.

[0078] As discussed above, identifying the use of the injector pen 102 and / or pen cap 104 may include identifying correct and / or incorrect use of the injector pen 102 and / or pen cap 104 .

[0079] As a non-limiting example, the controller 124 may determine whether the injector pen 102 is correctly or incorrectly inserted into the pen cap 104 . In some embodiments, the controller 124 may utilize information from one or more of the injection pen insertion detector, the injection pen insertion level detector, and the grip force detector to determine whether the injection pen 102 is correctly or incorrectly inserted into the pen cap 104. For example, the controller 124 may determine whether the injection pen 102 is fully inserted into the pen cap 104 (e.g., whether the longitudinal end of the injection pen 102 is within a predetermined distance from the end of the pen cap 104) via an injection pen insertion detector and / or an injection pen insertion level detector. Additionally, the controller 124 may determine, via a grip force detector, whether the force being applied to the injector pen 102 is within a predetermined range (eg, an appropriate range).

[0080] In response to determining that the injection pen 102 is fully inserted within the pen cap 104 and that the force being applied to the injection pen 102 is within a predetermined appropriate range, the controller 124 may determine that the injection pen 102 is properly inserted within the pen cap 104 and constitutes correct use (e.g., interaction). In response to determining that the injection pen 102 is not fully inserted within the pen cap 104 or that the force being applied to the injection pen 102 is outside a predetermined appropriate range, the controller 124 may determine that the injection pen 102 is improperly inserted within the pen cap 104, constituting incorrect use (e.g., interaction).

[0081] As another non-limiting example, the controller 124 may determine whether a capping or uncapping event of the pen cap 104 properly aligns with a scheduled and / or detected therapeutic agent dispensing action. For example, the controller 124 may determine whether the pen cap 104 has been uncapped from the injection pen 102 prior to or during a scheduled therapeutic drug dispensing operation. Additionally, the controller 124 may determine whether the pen cap 104 has been placed on the injection pen after a scheduled and / or detected therapeutic drug dispensing event.

[0082] In some embodiments, the controller 124 may determine the length of time that the pen cap 104 has been uncapped from the injection pen 102 and whether the time that the pen cap 104 has been uncapped from the injection pen 102 has been sufficient to perform a therapeutic drug dispensing operation.

[0083] In response to determining that a capping and / or uncapping event of the pen cap 104 properly aligns with a scheduled and / or detected therapeutic drug dispensing action, the controller 124 may determine or infer that the therapeutic drug dispensing action occurred properly and constitutes correct use (e.g., interaction). In response to determining that a capping and / or uncapping event of the pen cap 104 does not properly align with a scheduled and / or detected therapeutic drug dispensing action, the controller 124 may determine or infer that a therapeutic drug dispensing action did not occur, constituting incorrect use (e.g., interaction).

[0084] As described above, the controller 124 may also determine, via one or more 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 an 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 pen cap 104, and (5) the temperature experienced by the injection pen 102 and / or pen cap 104. Additionally, per the foregoing examples, the controller 124 may identify a use (eg, an interaction) for a detected or scheduled medication action. Additionally, for each of the foregoing examples, the controller 124 may determine whether the usage (eg, interaction) is correct or incorrect.

[0085] In response to analyzing the received information, method 300 may include determining feedback to provide to the user, as shown in operation 306 of FIG. For example, controller 124 may utilize the analysis performed above with respect to operation 304 of FIG. 3 to determine the feedback to provide to the user. For example, as described in more detail below, the controller 124 may determine the feedback to provide 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.

[0086] In some embodiments, determining the feedback to provide to the user may include determining whether feedback to the user is justified (e.g., necessary or appropriate) given an analysis of the received information. For example, if incorrect use is identified through analysis, the controller 124 may determine that feedback is appropriate, acknowledging the incorrect use and indicating that corrective action is required, and / or as an alarm.

[0087] As another non-limiting example, if correct use is identified via analysis, the controller 124 may determine that feedback is appropriate to indicate correct use to the user (e.g., that the user correctly performed the action (e.g., cap placement and / or medication administration)) and / or as positive reinforcement of the action. In some embodiments, if correct daily use is identified through analysis, the controller 124 may determine that feedback is not warranted or necessary. In some embodiments, determining whether feedback to the user is warranted may be based at least in part on a user profile and / or user preferences (e.g., previously made selections).

[0088] In some embodiments, only certain uses (eg, actions) are classified as legitimate feedback. For example, in one or more embodiments, uses determined and / or classified (e.g., classified by a provider) as important or necessary to a user's insulin treatment plan may be classified as legitimate feedback. For example, medication administration, cap placement and / or cap removal actions may be classified as valid feedback.

[0089] In one or more embodiments, determining the feedback to provide to the user may include determining the type of feedback to provide to the user. For example, the controller 124 may determine the type of feedback to provide, such as tactile, audible, and / or visual feedback. Additionally, in response to determining the type of feedback to provide to the user, the controller 124 may determine the form of the feedback. For example, with respect to haptic feedback, the controller 124 may determine one or more of the intensity, duration, amplitude, frequency, and / or cadence of the haptic feedback.

[0090] With respect to audible feedback, the controller 124 may determine one or more of the volume, tone, duration, amplitude, frequency, and / or cadence of the audible 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.

[0091] In some embodiments, the type and form of feedback may be pre-selected and customized via user settings, user profile, and / or provider settings, and the type and form of feedback may be customized within a drug treatment plan (e.g., an insulin treatment plan) to accommodate user preferences and / or capabilities.

[0092] In response to determining the feedback to provide to the user, the method 300 may include providing the feedback via one or more feedback components 146 of the pen cap 104 and / or feedback components of the injection pen 102, as shown in operation 308 of FIG. For example, the controller 124 may cause one or more feedback components 146 of the pen cap 104 to output the feedback determined in operation 306 of FIG.

[0093] As non-limiting examples, the controller 124 may cause one or more of a vibration motor in the pen cap 104, an audio transducer, or a display (e.g., the display screen 120), and / or feedback components in the injection pen 102 to output feedback.

[0094] As a non-limiting example, in embodiments in which the one or more feedback components 146 of the pen cap 104 include a vibration motor, the controller 124 may cause the vibration motor to vibrate according to the determined form of feedback. In embodiments in which one or more feedback components 146 of the pen cap 104 include an audio transducer, the controller 124 may cause the audio transducer to output sound according to the determined form of feedback. In embodiments in which the one or more feedback components 146 of the pen cap 104 include 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 form (e.g., visual appearance) of the feedback. Additionally, the controller 124 may cause one or more feedback components 146 of the pen cap 104 to provide feedback via any combination of the above-mentioned methods.

[0095] In some embodiments, the controller 124 may also cause the feedback components of the injector pen 102 to provide feedback via any combination of the above-described methods. For example, the controller 124 may cause the feedback component 146 of the pen cap 104 to output two or more types of feedback (e.g., both tactile feedback and audible feedback, both tactile feedback and visual feedback, or both audible feedback and visual feedback).

[0096] In some embodiments, the medication delivery device 100 (e.g., the pen cap 104) may transmit data to the client device 106 (e.g., a mobile device) along 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 transfer data to the client device 106 along with instructions to provide the determined feedback in addition to or instead of the feedback output by the drug delivery device 100.

[0097] 1-3, the drug delivery device 100, one or more detectors 144, and one or more feedback components 146 (collectively referred to herein as "drug delivery device 100") described herein may provide advantages over conventional delivery devices.

[0098] For example, the drug delivery device 100 of the present disclosure may improve the user experience when using the drug delivery device 100 by providing confirmation (e.g., feedback) of correct operation (e.g., correct use) and notification (e.g., creating awareness) of incorrect operation (e.g., incorrect use) when using the drug delivery device 100.

[0099] As described above, the medication delivery device 100 may provide feedback through tactile feedback (e.g., vibration feedback), which may create a consistent user experience when inserting the injection pen 102 into and removing the injection pen 102 from the pen cap 104 compared to conventional delivery devices. Additionally, a consistent user experience may reduce learning time and reduce user confusion compared to conventional delivery devices.

[0100] For example, users of conventional delivery devices may experience various challenges when operating the delivery device. One problem that users may experience when using conventional delivery devices is "diabetes fatigue syndrome" (DFS).

[0101] As used herein, DFS may be defined as a "multifactorial syndrome of fatigue or easy fatigability occurring in diabetic patients" that may be caused by a variety of factors. Therefore, reducing learning disabilities and reducing confusion when using a delivery device can reduce the cognitive burden on the user and improve the user experience. Another challenge that users may experience is neurological impairment.

[0102] PWDs often have nerve damage, and therefore providing feedback via haptic feedback can be beneficial to users with limited fine motor skills and dexterity. Similarly, tactile feedback may be beneficial to users with hearing and / or visual impairments. In light of the above, the medication delivery device 100 of the present disclosure may reduce the cognitive burden on the user by providing confirmation of correct actions and notification (e.g., creating awareness) of incorrect actions.

[0103] With continued reference to FIGS. 1-3 together, any of the above-described feedback may occur in response to different interactions between the injector pen 102 and the pen cap 104. For example, in response to the injection pen 102 being inserted into the pen cap 104 after administration of insulin, any of the above-described feedback may occur 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 using a needle and / or sheath, and / or when the injection pen 102 is removed from the pen cap 104.

[0104] The feedback described herein may include vibrations of a specified duration, amplitude, frequency, and / or rhythm. Additionally, the feedback parameters (e.g., tactile parameters) may depend on and / or be customized based on the drug treatment regimen and / or the therapeutic agent (e.g., type of insulin) present in the injection pen 102 (e.g., present in a cartridge within the injection pen 102).

[0105] The feedback parameters may be adjusted automatically and / or manually to address environmental and / or other challenges specific to a user undergoing a drug treatment regimen (e.g., utilizing a drug delivery device). For example, the parameters may be dependent on and / or customized based on a user profile of the user. For example, depending on the user's fine motor skills, parameters such as the length and amplitude of the haptic feedback may be adjusted to accommodate the user's preferences and / or abilities.

[0106] FIG. 4 is a block diagram of an exemplary computing device 400 that may be utilized as a client device (e.g., client device 106) or within and / or as part of medication delivery device 100, which may be configured to perform one or more of the processes described above. It will be appreciated that one or more computing devices may implement computing device 400 .

[0107] Computing device 400 may include a processor 402, memory 404, a storage device 406, an I / O interface 408, and a communication interface 410, which may be communicatively coupled by a communication infrastructure 412. Although an exemplary computing device is illustrated in Figure 4, the components illustrated in Figure 4 are not intended to be limiting. In other embodiments, additional or alternative components may be used. Furthermore, in certain embodiments, computing device 400 may include fewer components than those shown in Figure 4. The components of computing device 400 shown in Figure 4 will now be described in more detail.

[0108] In one or more embodiments, processor 402 includes hardware for executing instructions, such as those making up a computer program. By way of example, and not limitation, to execute instructions, processor 402 may retrieve (or fetch) instructions from an internal register, an internal cache, memory 404, or storage device 406, decode them, and execute them.

[0109] In one or more embodiments, processor 402 may include one or more internal caches for data, instructions, or addresses. By way of example and not limitation, processor 402 may include one or more instruction caches, one or more data caches, and one or more translation lookaside buffers (TLBs). Instructions in an instruction cache may be copies of instructions in memory 404 or storage device 406.

[0110] The memory 404 may be used to store data, metadata, and programs for execution by the processor. The memory 404 may include one or more of volatile and non-volatile memory, 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. The memory 404 may be an internal memory or a distributed memory.

[0111] The storage device 406 includes a storage device for storing data or instructions. By way of example, and not limitation, the storage device 406 may comprise a non-transitory storage medium as described above. The 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 magnetic tape, or a Universal Serial Bus (USB) drive, or a combination of two or more of these. The storage device 406 may include removable or non-removable (or fixed) media, where appropriate. The storage device 406 may be internal or external to the computing device 400 .

[0112] In one or more embodiments, the storage device 406 is non-volatile solid-state memory. In other embodiments, storage device 406 includes read-only memory (ROM), which may be mask-programmed ROM, programmable ROM (PROM), erasable PROM (EPROM), electrically erasable PROM (EEPROM), electrically alterable ROM (EAROM), or flash memory, or a combination of two or more of these, where appropriate.

[0113] I / O interface 408 allows a user to provide input to, receive output from, and otherwise transfer data to and receive data from 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.

[0114] 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 particular embodiments, I / O interface 408 is configured to provide graphical data to a display for presentation to a user. The graphical data may represent one or more graphical user interfaces and / or any other graphical content useful in a particular implementation.

[0115] The communication interface 410 may include hardware, software, or both. In any event, communication interface 410 may provide one or more interfaces for communication (e.g., packet-based communication, etc.) 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. Additionally or alternatively, communication interface 410 may facilitate communication with one or more portions of 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 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. By way of example, communication interface 410 may facilitate communication with a wireless PAN (WPAN) (e.g., a BLUETOOTH® WPAN, etc.), a WI-FI network, a WI-MAX network, a cellular network (e.g., a Global System for Mobile Communications (GSM) network), or other suitable wireless network, or a combination thereof.

[0116] Additionally, communication interface 410 may facilitate communication of various communication protocols. Examples of communication protocols that may 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"), Hypertext Transfer Protocol Secure ("HTTPS"), Session Initiation Protocol ("SIP"), Simple Object Access Protocol ("SOAP"), Extensible Markup Language ("XML") and variations thereof, 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"), 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.

[0117] Communications infrastructure 412 may include hardware, software, or both that couple the components of computing device 400 together. By way of example, and not limitation, communications 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.

[0118] Embodiments of the present disclosure further include: Embodiment 1. A method of providing feedback to a user of a medication delivery device, the method comprising: receiving information from one or more detectors in a pen cap of the medication delivery device; analyzing the received information to identify at least one of incorrect use or correct use of the medication delivery device; and providing feedback via one or more feedback components in the pen cap of the medication delivery device in response to identifying the one or more incorrect uses or correct uses. Embodiment 2. The method of embodiment 1, wherein identifying at least one of incorrect use or correct use comprises identifying a physical interaction between a pen cap of the medication delivery device and an injection pen. Embodiment 3. The method of any one of embodiments 1 or 2, wherein identifying at least one of incorrect use or correct use includes identifying a cap installation event between a pen cap of the medication delivery device and an injection pen of the medication delivery device. Embodiment 4. The method of any one of embodiments 1 to 3, wherein identifying at least one of incorrect use or correct use comprises identifying a cap removal event between a pen cap of the medication delivery device and an injection pen of the medication delivery device. Embodiment 5. The method of any one of embodiments 1 to 4, wherein identifying at least one of incorrect use or correct use comprises identifying the insertion of a new injection pen into the pen cap of the medication delivery device. Embodiment 6. The method of any one of embodiments 1 to 5, wherein identifying at least one of incorrect use or correct use comprises identifying incomplete insertion of an injection pen of the medication delivery device into a pen cap of the medication delivery device. Embodiment 7. The method of any one of embodiments 1 to 6, wherein identifying at least one of incorrect use or correct use comprises identifying full insertion of an injection pen of the medication delivery device into a pen cap of the medication delivery device. Embodiment 8. The method of any one of embodiments 1 to 7, wherein identifying at least one of incorrect use or correct use includes identifying insertion of an injection pen of the medication delivery device into a pen cap of the medication delivery device using at least one of a needle or a sheath. Embodiment 9. The method of any one of embodiments 1 to 8, wherein receiving information from one or more detectors of a pen cap of the medication delivery device comprises receiving information from an injection pen insertion detector. Embodiment 10. The method of embodiment 9, wherein receiving information from the injection pen insertion detector includes receiving information regarding insertion of the injection pen into the pen cap or removal of the injection pen into the pen cap. Embodiment 11. The method of any one of embodiments 1 to 10, wherein receiving information from one or more detectors of a pen cap of the medication delivery device comprises receiving information from an injection pen insertion level detector. Embodiment 12. The method of embodiment 11, wherein receiving information from the injection pen insertion level detector includes receiving information regarding the proximity of the end of the injection pen to the end of the pen cap opposite the opening of the pen cap. Embodiment 13. The method of any one of embodiments 1 to 12, wherein receiving information from one or more detectors of a pen cap of the medication delivery device comprises receiving information from an injection pen pull force detector. Embodiment 14. The method of embodiment 13, wherein receiving information from the injection pen tensile force detector includes receiving information regarding the amount of force the injection pen is subjected to in a direction parallel to the longitudinal axis of the pen cap. Embodiment 15. The method of any one of embodiments 1 to 14, wherein receiving information from one or more detectors of a pen cap of the medication delivery device comprises receiving information from a grip force detector. Embodiment 16. The method of embodiment 15, wherein receiving information from the grip force detector includes receiving information regarding the amount of force being applied to the injection pen by the pen cap. Embodiment 17. A medication delivery device comprising an injection pen and a pen cap, wherein the pen cap comprises one or more detectors, a vibration motor, and a controller, wherein the controller comprises at least one processor and at least one non-transitory computer-readable storage medium storing instructions, which, when executed by the at least one processor, cause the controller to receive information regarding a physical interaction between the pen cap and the injection pen from the 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 medication 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. Embodiment 18. The medication delivery device of embodiment 17, wherein the one or more detectors of the pen cap comprise one or more of an injection pen insertion detector, an injection pen insertion level detector, an injection pen pull force detector, or a grip force detector. Embodiment 19. A medication delivery device as described in any one of embodiments 17 or 18, further comprising instructions that, when executed by at least one processor, cause the controller to identify at least one of an incorrect medication dispensing operation or a correct medication dispensing operation, and provide feedback via a vibration motor of the medication delivery device in response to identifying at least one of the incorrect medication dispensing operation or the correct medication dispensing operation. Embodiment 20. A non-transitory computer-readable medium storing instructions that, when executed by at least one processor, cause the at least one processor to perform steps including receiving information regarding a physical interaction between a pen cap of a medication delivery device and an injection pen; analyzing the received information to identify at least one erroneous physical interaction between the pen cap and the injection pen; and providing tactile feedback via the pen cap in response to identifying the at least one erroneous physical interaction.

[0119] The embodiments of the present disclosure described above and illustrated in the accompanying drawings are merely examples of embodiments of the present invention, as defined by the appended claims and their legal equivalents, and therefore these embodiments do not limit the scope of the present invention. Any equivalent embodiments are intended to be within the scope of the present invention. Indeed, various modifications of the present disclosure, in addition to those shown and described herein, may become apparent to those skilled in the art from the description, including alternative useful combinations of the described content features. Such modifications and embodiments are also intended to be included within the scope of the appended claims and their legal equivalents.

Claims

1. 1. A method for providing feedback to a user of a medication delivery device, comprising: receiving information from a detector in a pen cap of the medication delivery device; analyzing the received information to identify at least one of incorrect use of the medication delivery device or correct use of the medication delivery device; and providing feedback via at least one feedback component of the pen cap of the medication delivery device in response to the identification of at least one of incorrect use or correct use.

2. 10. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying a physical interaction between the pen cap of the medication delivery device and an injection pen.

3. 2. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying a cap installation event between the pen cap of the medication delivery device and an injection pen of the medication delivery device.

4. 2. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying a cap removal event between the pen cap of the medication delivery device and an injection pen of the medication delivery device.

5. 10. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying the insertion of a new injection pen into the pen cap of the medication delivery device.

6. 2. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying incomplete insertion of an injection pen of the medication delivery device into the pen cap of the medication delivery device.

7. 2. The method of claim 1, wherein identifying at least one of incorrect use or correct use comprises identifying full insertion of an injection pen of the medication delivery device into the pen cap of the medication delivery device.

8. 2. The method of claim 1, wherein the step of identifying at least one of incorrect use or correct use comprises the step of identifying insertion of an injection pen of the medication delivery device into the pen cap of the medication delivery device using at least one of a needle or a sheath.

9. 10. The method of claim 1, wherein receiving information from a detector of the pen cap of the medication delivery device comprises receiving information from an injection pen insertion detector.

10. 10. The method of claim 9, wherein receiving information from the injection pen insertion detector comprises receiving information regarding insertion of an injection pen into the pen cap or removal of the injection pen from the pen cap.

11. 10. The method of claim 1, wherein receiving information from a detector of the pen cap of the medication delivery device comprises receiving information from an injection pen insertion level detector.

12. 12. The method of claim 11, wherein receiving information from the injection pen insertion level detector comprises receiving information regarding the proximity of an end of an injection pen to an end of the pen cap opposite an opening in the pen cap.

13. 10. The method of claim 1, wherein receiving information from a detector of the pen cap of the medication delivery device comprises receiving information from an injection pen pull force detector.

14. 14. The method of claim 13, wherein receiving information from the injection pen pull force detector comprises receiving information regarding an amount of force experienced by the injection pen in a direction parallel to a longitudinal axis of the pen cap.

15. The method of claim 1 , wherein receiving information from a detector of the pen cap of the medication delivery device comprises receiving information from a grip force detector.

16. 16. The method of claim 15, wherein receiving information from the grip force detector comprises receiving information regarding an amount of force being applied to an injection pen by the pen cap.

17. An injection pen, Pen cap and 1. A medication delivery device comprising: one or more detectors; a vibration motor; Controller and wherein the controller: at least one processor; at least one non-transitory computer-readable storage medium storing instructions; the instructions, when executed by the at least one processor, cause the controller to: receiving information from the one or more detectors of the pen cap regarding a physical interaction between the pen cap and the injection pen; 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 providing feedback via the vibration motor of the medication 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.

18. 18. The medication delivery device of claim 17, wherein the one or more detectors of the pen cap comprise one or more of an injection pen insertion detector, an injection pen insertion level detector, an injection pen pull force detector, or a grip force detector.

19. When executed by the at least one processor, the controller: identifying at least one of an incorrect medication dispensing action or a correct medication dispensing action; 18. The medication delivery device of claim 17, further comprising instructions to: provide feedback via the vibration motor of the medication delivery device in response to identifying at least one of an incorrect medication dispensing operation or a correct medication dispensing operation.

20. 1. A non-transitory computer-readable medium storing instructions that, when executed by at least one processor, cause the at least one processor to: receiving information regarding a physical interaction between a pen cap of a medication delivery device and an injection pen; analyzing the received information to identify at least one erroneous physical interaction between the pen cap and the injection pen; and providing tactile feedback via the pen cap in response to identifying the at least one erroneous physical interaction.

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