Drug delivery device, system and method

Abstract

Drug delivery methods, devices, and systems are provided. A drug delivery device includes a user interface element, a control circuit, and a memory. In one embodiment, a method includes receiving analyte measurement data of a user, presenting information related to the analyte measurement data to the user, and determining an expected dose of a drug based on one or more of the analyte measurement data, optional therapy-related conditions, therapy parameters, or calculated active insulin (IOB) values. When a user is queried whether a desired dose has been ready for delivery without presenting the desired dose on any of one or more user interface elements of the drug delivery device, the desired dose will be automatically delivered after receiving a user confirmation indication.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Application Serial No. 63 / 365,849 filed on June 3, 2023 and U.S. Application Serial No. 63 / 382,443 filed on November 4, 2022. The disclosure of the prior application is considered part of the disclosure of the present application, which is incorporated in its entirety into the present application. Technical Field

[0003] The present disclosure relates generally to drug delivery devices and methods. More specifically, the present disclosure relates to devices and methods for automatically delivering a desired dose of a drug to a user. Background Art

[0004] Diabetes treatment devices (e.g., blood glucose meters, insulin pumps, insulin injection devices, etc.) are widely used by patients with diabetes (PWD) to self-administer external biologically effective drugs (e.g., insulin or its analogs). Some diabetes treatment devices or mobile applications are equipped with insulin bolus calculators to recommend insulin bolus doses for PWD. Typically, the actual amount of drug to be delivered is determined by the patient. Summary of the invention

[0005] The present disclosure relates generally to drug delivery devices and methods. More specifically, the present disclosure relates to devices and methods for automatically delivering an intended dose of a drug to a user without presenting the dose to the user on any user interface of the drug delivery device.

[0006] In brief, in one embodiment, the present disclosure describes a method for delivering a drug using a drug delivery device. The drug delivery device includes one or more user interface elements, a control circuit, and a memory. The method includes receiving analyte measurement data of a user via a drug delivery device; presenting information related to the analyte measurement data to the user via one or more user interface elements; based on at least one analyte measurement data, one or more therapy-related conditions, one or more therapy parameters stored in a storage device of the drug delivery device, or a calculated active insulin (insulin-on-board, IOB) value, determining the expected dose of the drug; asking the user whether the drug is ready for delivery without presenting the expected dose on any of the one or more user interface elements of the drug delivery device; and automatically delivering the expected dose after receiving a confirmation indication from the user.

[0007] In another embodiment, the present disclosure describes a drug delivery device, which includes a housing configured to accommodate a cartridge. The cartridge extends between its distal end and proximal end, and includes a vial with a diaphragm at the distal end and a displacement member inside the vial, the displacement member being movable from the proximal end to the distal end to deliver the drug contained in the vial from the distal end. The drug delivery device also includes a drive mechanism and one or more position sensors located inside the housing, wherein the drive mechanism is configured to move the displacement member forward in the cartridge to deliver the drug when the cartridge is accommodated in the housing, and the one or more position sensors are positioned to detect the position of the displacement member in the cartridge when the cartridge is accommodated in the housing. The drug delivery device also includes a control circuit configured to determine an expected dose of the drug to be delivered, and to obtain information from one or more position sensors. The information represents the position of the displacement member in the cartridge. The control circuit is also configured to determine a first position of the displacement member in the cartridge based on information from the one or more position sensors. The first position represents the position of the displacement member before delivering the drug dose. The control circuit is further configured to determine a second position of the displacement member within the medical device based on an expected dose of the drug to be delivered, the second position representing a desired position of the displacement member within the cartridge after the dose of the drug is delivered. The control circuit is further configured to instruct advancement of the displacement member from the first position, and to instruct cessation of advancement of the displacement member after obtaining information from the one or more position sensors indicating that the displacement member has reached the second position.

[0008] In another embodiment, the present disclosure describes a method for delivering a drug using a drug delivery device, the drug delivery device comprising a housing configured to accommodate a cartridge, the cartridge extending between a distal end and a proximal end thereof and comprising a vial having a septum at the distal end and a displacement member in the vial, the displacement member being movable from the proximal end to the distal end to deliver the drug contained in the vial from the distal end, the drug delivery device further comprising a drive mechanism inside the housing, one or more position sensors positioned to detect a position of the displacement member in the cartridge, and a control circuit configured to control the operation of the drug delivery device, wherein the drive mechanism is configured to cause the displacement member to move forward in the cartridge to deliver the drug when the cartridge is accommodated in the housing, the method comprising the control circuit determining an expected dose of the drug to be delivered; the one or more position sensors detecting the displacement member The control circuit determines the position of the displacement member in the cartridge and provides information indicating the position of the cartridge to the control circuit; the control circuit obtains information indicating the position of the displacement member in the cartridge from one or more position sensors; the control circuit determines a first position of the displacement member in the cartridge based on the information from the one or more position sensors, wherein the first position represents the position of the displacement member before delivering a dose of the drug; the control circuit determines a second position of the displacement member in the drug device based on an expected dose of the drug to be delivered, wherein the second position represents the expected position of the displacement member in the cartridge after delivering the dose of the drug; the control circuit instructs the displacement member to be moved forward from the first position; and the control circuit instructs to stop moving the displacement member forward after obtaining information indicating that the displacement member has reached the second position from the one or more position sensors.

[0009] Various aspects and advantages of exemplary embodiments of the present disclosure have been summarized. The above summary is not intended to describe each illustrated embodiment. Other features and aspects will become apparent by considering the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Reference is made to the accompanying drawings, which constitute a part of this disclosure and illustrate embodiments in which the systems and methods described in this specification may be implemented.

[0011] Figure 1 is a block diagram of a medication delivery and management system according to one embodiment.

[0012] Figure 2 is a block diagram of a drug delivery device according to one embodiment.

[0013] Figure 3 is a top perspective view of a drug delivery device according to one embodiment.

[0014] Figure 4A yes Figure 3 A perspective view of a test of a drug delivery device.

[0015] Figure 4B yes Figure 4A A first end view of a drug delivery device.

[0016] Figure 4C yes Figure 4A A second end view of a drug delivery device.

[0017] Figure 5A yes Figure 3 Cross-sectional view of a drug delivery device.

[0018] Figure 5B yes Figure 5A A cross-sectional view of a portion of a drug delivery device.

[0019] Figure 6 is a flow chart of a method of delivering a drug using a drug delivery device according to one embodiment.

[0020] Figure 7 is a flow chart of a method of delivering a drug using a drug delivery device according to another embodiment.

[0021] Figure 8 Shown is a screenshot of a user interface of a medication delivery device according to some embodiments.

[0022] Specific embodiments of the present disclosure are described herein with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present disclosure, and the present disclosure can be implemented in various forms. Well-known functions or structures are not described in detail to avoid unnecessary details obscuring the present disclosure. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to use the present disclosure in different ways in essentially any appropriate detailed structure. In this specification and the drawings, similar reference numerals represent similar elements that can perform the same, similar, or equivalent functions. DETAILED DESCRIPTION

[0023] The present disclosure generally relates to drug delivery devices and methods. More specifically, the present disclosure relates to devices and methods for automatically delivering an expected dose of a drug to a user, particularly without presenting any dose information to the user on any user interface element of the drug delivery device.

[0024] The systems, devices, and methods described herein can be applied to the delivery of a variety of medications and the management of a variety of diseases, including, for example, diabetes medications, anticoagulants such as heparin, palliative pain medications, growth hormone deficiency treatments such as growth hormone, fertility treatments such as human chorionic gonadotropin or follicle-stimulating hormone, and the like.

[0025] In some embodiments, the systems, devices, and methods described herein can provide multiple daily deliveries of a drug (e.g., a mixture of rapid-acting and long-acting insulin) to a user via a drug delivery device. The systems, devices, and methods allow a user (e.g., a diabetic or PWD) to easily administer multiple daily deliveries of a drug without burdening the user with the mental tasks of calculating an appropriate drug bolus dose, assessing the effect of therapy-related conditions (e.g., meal size, exercise program, or other lifestyle factors) on the drug bolus dose, and determining the actual dose delivered.

[0026] Drug delivery and management systems

[0027] Figure 1 A drug delivery and management system 100 is shown. In one embodiment, the system 100 is an insulin therapy delivery and management system. It should be understood that the system 100 can be applied to the delivery of various drugs and the management of various diseases. The system 100 includes an analyte sensor system 102, one or more drug delivery devices 110, a mobile application 104, and optionally one or more auxiliary devices 106. The drug delivery and management system 100 may also include one or more network services 105, which communicate with the mobile application 104 via a network 108 (e.g., a cloud network). One or more drug delivery devices 110 can join and leave the system 100, interact with a user to determine an expected dose, and automatically deliver an expected dose of a drug to the user without presenting the expected dose on any user interface element of the drug delivery device 110.

[0028] In some cases, one or more drug delivery devices 110 may be a syringe, which may have a suitable shape, such as a pen shape, etc. In some cases, one or more drug delivery devices 110 may include an insulin delivery device, such as an insulin injection pen, etc. In some cases, the insulin injection pen may be reused by receiving an insulin cartridge, ejecting the insulin cartridge, and receiving a new insulin cartridge.

[0029] The analyte sensor system 102 is configured to obtain various analyte measurement data and transmit the analyte measurement data to the drug delivery device 110. In some cases, the analyte sensor system 102 may include a blood glucose sensor system suitable for determining blood glucose values, including, for example, a blood glucose meter (BGM), a rapid blood glucose monitor, a continuous blood glucose monitor (CGM), etc. In some cases, the blood glucose sensor system 102 may act as a rapid blood glucose monitor or a continuous blood glucose monitor by allowing intermittent and / or on-demand transmission of blood glucose data, or act as a blood glucose monitor and a continuous blood glucose monitor at the same time. In some cases, the blood glucose sensor system 102 may detect changes in blood glucose values ​​within a specified time period and provide blood glucose trend data. In some cases, when inquired by a reading device (e.g., using NFC communication), the analyte sensor system 102 may transmit data wirelessly. In some cases, the blood glucose sensor may use any suitable communication standard (e.g., low power consumption Bluetooth (BLE)) to transmit data wirelessly at predetermined time intervals (e.g., using radio frequency). In some cases, the analyte sensor system 102 may include multiple blood glucose sensor systems (e.g., one or more of a continuous blood glucose monitor, a rapid blood glucose monitor, a blood glucose meter, etc.).

[0030] The analyte sensor system 102 can transmit analyte measurement data (e.g., blood glucose data) using a variety of communication technologies. In some embodiments, the mobile application 104 and / or one or more drug delivery devices 110 can include an NFC reader that is suitable for obtaining analyte measurement data from the analyte sensor system 102 when brought within the query distance of the analyte sensor system 102. In some embodiments, the mobile application 104 and / or one or more drug delivery devices 110 can wirelessly receive analyte measurement data from the analyte sensor system 102, which is broadcast at a predetermined time period (every 30 seconds, every minute, every 2 minutes, every 3 minutes, every 5 minutes, every 10 minutes, every 15 minutes, etc.).

[0031] In the query operation mode, the analyte sensor system 102 can wirelessly send analyte measurement data to the mobile application 104 and / or one or more drug delivery devices 110. For example, when the drug delivery device 110 queries the blood glucose sensor system 102, it can receive data stored from the previous 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, etc. In some cases, the blood glucose data reported can include the current or earlier blood glucose value and the current blood glucose trend data. In some cases, the mobile application 104 and / or one or more drug delivery devices 110 can directly receive the latest blood glucose data (e.g., from the last 5, 10, 20 or 30 minutes) from the blood glucose sensor system 102, and issue an alarm, warning or notification based on the latest blood glucose data.

[0032] The drug delivery device 110 may be configured to capture information related to drug delivery, including, for example, one or more user interface elements for presenting or displaying information and receiving user input, internal sensors for actual dose capture, and other communication interfaces for wireless or wired communication with one or more of other drug delivery devices 110, analyte sensor system 102, mobile application 104, and optional auxiliary device 106. In some cases, the drug delivery device 110 may be associated with various specific types of insulin (such as rapid-acting insulin, long-acting insulin, a mixture of rapid-acting and long-acting insulin, etc.). Rapid-acting insulin can start working about 15 minutes after injection, reach a peak about one or two hours after injection, and last for about two to four hours. Long-acting insulin can reach the bloodstream several hours after injection and reduce blood sugar levels within up to 24 hours. In some embodiments, the first drug delivery device 110 can be associated with long-acting insulin delivery, and the second drug delivery device 110 can be associated with rapid-acting insulin delivery. It should be understood that the drug delivery device 110 can be configured to deliver any type of insulin except rapid-acting insulin and long-acting insulin.

[0033] The drug delivery device 110 may execute one or more algorithms to determine an expected dose of a drug based on the analyte measurement data from the analyte sensor system 102. In some cases, the expected dose may also be determined based on one or more therapy-related conditions input from a user, one or more therapy parameters stored in a memory of the drug delivery device 110, or a calculated insulin active (IOB) value. The drug delivery device 110 may have one or more user interface elements to present a query to the user asking if the user is ready to deliver without presenting the expected dose on any user interface element of the drug delivery device 110. After receiving a confirmation indication from the user, the drug delivery device 110 may automatically deliver the expected dose.

[0034] In the embodiments described herein, in the normal functional mode of the drug delivery device 110, the determined expected dose is generally not displayed to the user via one or more user interface elements. In some cases, the drug delivery device can operate in a service / maintenance mode, in which case the expected dose or other dose-related information can be presented or displayed via one of the user interface elements of the drug delivery device 110, for example, to a device service / maintenance technician. For example, the service / maintenance mode can be triggered by a mobile application after a complex function is entered on the drug delivery device 110 or through an auxiliary device. In some cases, the expected dose or other dose-related information can be presented or displayed via one or more user interface elements of the drug delivery device 110 in certain service / maintenance modes with certain limitations, such as in a small font size that is not easily perceived by the user.

[0035] In some embodiments, when a user wants to access and / or adjust an expected dose determined by the drug delivery device 110 and not presented on any user interface element of the drug delivery device 110, the user can use one or more optional auxiliary devices 106 to access and / or adjust the expected dose. The auxiliary device 106 may include, for example, a smart phone, a laptop, a tablet, a portable computer, etc. The auxiliary device 106 may each include a user interface for interacting with the user. The auxiliary device 106 may present a query to the user to ask whether the user needs to access and / or manually adjust the expected dose determined by the drug delivery device 110. The auxiliary device 106 may receive a dose amount representing the expected dose or an adjusted user input dose. The auxiliary device 106 may wirelessly communicate with the drug delivery device 110 to transmit the received user input dose to the drug delivery device 110. After receiving the user input dose from the auxiliary device 106, the drug delivery device 110 may present (e.g., display) an indication that the drug delivery device 110 has received the user input dose from the auxiliary device 106 via at least one of its user interface elements. The drug delivery device 110 may query the user whether the user is ready for delivery of the user-input dose, and automatically deliver the user-input dose upon receiving a confirmation indication from the user.

[0036] In some embodiments, the drug delivery device 110 can execute one or more algorithms to determine the actual dose of the drug after the expected dose is delivered. The drug delivery device 110 can compare the actual dose with the expected dose. When the actual dose is different from the expected dose, the drug delivery device 110 can calculate the active insulin (IOB) value based on the actual dose, and calculate the subsequent expected dose for the next scheduled time based on the calculated IOB value. The IOB value refers to the amount of active insulin remaining in the user's body. Based on historical data and current data on the actual dose delivered to the user, the drug delivery device 110 can execute one or more algorithms to calculate or predict the user's current IOB value.

[0037] In some embodiments, the drug delivery device 110 may execute one or more algorithms to generate a query and present the query to the user via one or more user interface elements of the drug delivery device 110 to request the user to enter a therapy-related condition. The therapy-related condition may include any external factor that may biologically affect the user's need for medication, including, for example, at least one of meal size, exercise schedule, sleep schedule, other lifestyle factors, etc. When the user is about to eat a meal, a query may be presented to the user via the user interface of the drug delivery device 110 to request the user to enter an indication of the meal size or meal category (e.g., small, medium, or large). The indication of the meal size or meal category (e.g., a meal icon or indicator) may be based on the size of the icon, the number of carbohydrates displayed, a label (e.g., Small or S, Medium or M, Large or L), or other meal characteristics (such as a preferred meal selection made by the user, a meal with a selected nutritional characteristic (e.g., carbohydrates), certain meals based on the time of day (e.g., breakfast, lunch, dinner, snacks), etc.). It should be understood that in some embodiments, the drug delivery device 110 may not present dosage recommendations for different meal sizes with small, medium, or large effects on blood sugar on any of its user interface elements. Instead, the drug delivery device 110 receives one or more therapy-related conditions (e.g., meal size) input by the user, and determines the expected dosage of the drug based on the received therapy-related conditions without presenting the dosage on any user interface element of the drug delivery device.

[0038] In some embodiments, an inquiry to a therapy-related condition of a user can be generated or determined based on the user's personalized pattern data. The user's personalized pattern data may include the user's lifestyle factor data or historical data related to the following, such as the user's meal time of the day, the user's drug delivery time of the day, the user's exercise time of the day, the user's sleep time of the day, the analyte measurement data (e.g., blood sugar level) of different therapy-related conditions input by the user, actual dosage data, etc. The lifestyle factor data or historical data can be collected by the analyte sensor system 102, the drug delivery device 110, the mobile application 104, and / or other components of the system 100. The drug delivery device 110 may include a memory for storing the user's personalized pattern data. The drug delivery device 110 can determine the content of the inquiry and the time (e.g., time of the day) of the inquiry presented to the user on its user interface element based on the user's personalized pattern data.

[0039] In some embodiments, the drug delivery device 110 may include a memory for storing user-specific therapy or dosage parameters, including, for example, a predetermined daily dose or total daily basal dose (TDBD) of long-acting insulin, an insulin sensitivity factor (ISF), a carbohydrate to insulin ratio (CR), a correction amount based on a blood glucose level range, a total daily insulin dose (TDD), a target blood glucose value, a recommended rapid-acting dose for different meal sizes or meal categories, etc. In some embodiments, the user-specific therapy or dosage parameters may be time or date related. For example, CR and ISF values ​​may depend on the time of day. In some embodiments, the drug delivery device 110 may include a memory that stores predetermined doses of rapid-acting insulin for different meals or for different meal sizes or meal categories.

[0040] In some embodiments, user-specific dosage parameters and / or different predetermined dosages for different meals can be updated via a mobile application 104 that wirelessly communicates with one or more drug delivery devices 110. For example, an algorithm in an auxiliary device 106 or network 108 can update a user-specific therapy or dosage parameter. In some embodiments, the user-specific therapy or dosage parameter can be updated by a healthcare professional or manually by a user or caregiver. In some embodiments, the drug delivery device 110 can include an algorithm in a memory that is executed by a processor to automatically update the user-specific therapy or dosage parameter.

[0041] In some embodiments, the drug delivery device 110 may display the current blood glucose level and / or blood glucose trend data (e.g., rate of change of blood glucose level) to the user or otherwise provide notification to the user based on the blood glucose data received from the analyte sensor system 102. The drug delivery device 110 may automatically determine the expected dose of a drug (e.g., insulin) based on one or more of the blood glucose data, user-specific therapy or dosage parameters, therapy-related conditions input by the user, a recommended dose set by a user or a healthcare professional, time of day, meal data or category, or any other suitable input.

[0042] The mobile application 104 may be stored and executed on any suitable mobile computing device, such as one or more auxiliary devices 106, which may be, for example, smart phones, laptops, tablet computers, etc. The mobile application 104 may be adapted to input and output (e.g., display) therapy-related information wirelessly received from other components of the system 100. The mobile application 104 may allow the use of a graphical user interface (GUI) that enables a user to interact with the mobile application 104.

[0043] In some embodiments, the auxiliary device 106 may store and execute a trusted mobile application within a trusted execution environment (hardware and / or software). Various functions and computations associated with the drug delivery and therapy management system 100, including notifications, warnings, queries, and recommendations presented to the user, may be performed at least in part by the trusted mobile application. Additionally, some or all communications with the drug delivery device 110 may be limited to the trusted mobile application or the trusted mobile computing device. In some cases, the mobile application 104 may allow an authorized user to access the drug delivery device 110 via a trusted mobile computing device such as Figure 1 to adjust the expected dose to be delivered by one or more drug delivery devices 110 using auxiliary devices 106 and the like.

[0044] In general, embodiments of the present disclosure may use any suitable wireless communication protocol to communicate between drug delivery devices, analyte sensor systems, auxiliary devices, other electronic devices, and / or other mobile applications of system 100. Examples of suitable wireless communication protocols include near field communication (technology compliant with ISO / IEC 14443 and 18092), wireless modems and routers (technology compliant with IEEE 802.11), and Bluetooth® / Bluetooth Low Energy (BLE) (technology compliant with IEEE802.15).

[0045] In some cases, one or more drug delivery devices 110 may include one or more accessories, such as a cover and / or a carrying case for the drug delivery device 110. One or more drug delivery devices 110 and accessories may be integrated (e.g., attached or functionally connected) into an electronic package (e.g., a smart electronic device) and executed therein.

[0046] In some cases, one or more drug delivery devices 110 may be paired with the system 100 via a profile created by the mobile application 104. In one embodiment, the mobile application 104 may query the network service 105 whether a device profile already exists for a particular user, and if so, request that it be sent. The user profile may include the user's personalized mode data, for example, including a determination algorithm for determining the user's expected dose, the user's historical data or physiological attributes (e.g., insulin sensitivity), historical data or current data related to actual blood glucose measurement and blood glucose response analysis, etc. After creating the user profile, the mobile application 104 may save insulin therapy related settings with the profile. The insulin therapy related settings may include user-specific dosing parameters of the user, delivery characteristics of the device, specific techniques that can be used to determine the expected dose, etc. In one embodiment, each delivery device profile may include or be part of a user profile that includes a preset correction dose for specific analyte measurement data (e.g., a specific blood glucose range) or specific therapy-related conditions (e.g., different meal sizes). In one embodiment, the preset dose may be entered in the mobile application 104. In another embodiment, a pre-set dosage may be entered into one of the web services 105 (eg, by a healthcare provider or parent) and downloaded to the mobile application 104 .

[0047] In some embodiments, a user profile including user personalized mode data can be generated by the system 100 and updated over time. The system 100 can allow a user or a healthcare professional to generate a user profile through the mobile application 104 or the network service 105, for example, by setting the user's therapy parameters (e.g., daily dose of long-acting insulin, dose for different meal sizes or meal categories, insulin sensitivity factor, carbohydrate to insulin ratio, etc.), by creating a correction dose table for a specific blood glucose value range, etc. The user profile can be stored in the memory of the drug delivery device 110 and updated over time. For example, in some embodiments, one or more of the blood glucose data received from the analyte sensor system 102, the actual dose data determined by the drug delivery device 110, or the calculated IOB value can be analyzed to adjust the user's dose parameters and / or meal-based dose correction.

[0048] Drug delivery devices

[0049] Figure 2 is suitable for use as a Figure 11 is a block diagram of a drug delivery device 200 of a drug delivery device 110 in a system 100 of the present invention. The drug delivery device 200 includes a control circuit 210, a communication interface 202, a memory 204, a sensing and actuation assembly 208, and one or more user interface elements 206. The sensing and actuation assembly 208 includes a drive mechanism 220, one or more position sensors 230, and one or more skin sensors 240. The drive mechanism 220 is configured to move a displacement member (e.g., a plunger) forward of a cartridge contained in a housing to deliver a drug from the cartridge. One or more position sensors 230 are positioned to detect the position of the displacement member (e.g., a plunger) within the cartridge. In some cases, the drive mechanism 220 may include a forward movement mechanism (e.g., a piston) engaged with the displacement member (e.g., a plunger) of the cartridge. The position sensor 230 is positioned to detect the position of the forward movement mechanism or the displacement member within the cartridge when the cartridge is contained in the drug delivery device 200. Examples for detecting the position of a displacement member are described in the following documents: U.S. Patent Nos. 9,255,830; 9,255,830; 10,255,991; and 10,183,120; and PCT Publication Nos. WO2019 / 123257; WO2019 / 123258; WO2017 / 009724; WO2019 / 186261; WO2020 / 255085; WO2019 / 123441 and WO2019 / 123441, all of which are incorporated herein by reference in their entirety. One or more skin sensors 240 are positioned at the distal end of the housing to detect the user's skin. The control circuit 210 receives sensing data from the skin sensor 240 to determine whether the drug delivery device 200 is in the correct position, location, or orientation for drug delivery. In some cases, the various device components can be housed or supported by the housing and integrated into an intelligent electronic device.

[0050] The communication interface 202 may include any suitable hardware, circuitry, logic, firmware, and other related components of the drug delivery device 200 that are coupled to the control circuit 210 and configured to support communication between the drug delivery device 200 and one or more external electronic devices, mobile computing devices, and cloud networks (such as Figure 1 In some cases, the communication interface 202 may use one or more wireless communication technologies, such as near field communication (NFC), Bluetooth low energy (BLE), WiFi, etc. In some embodiments, the communication interface 202 may also support wired communication.

[0051] The one or more user interface elements 206 may include any suitable hardware, circuitry, logic, firmware, and other related components of the drug delivery device 200, which are configured to support user communication and interaction between the drug delivery device 200 and the user. The one or more user interface elements 206 associated with the drug delivery device 200 may include one or more output elements, including, for example, a visual output device (such as a display, etc.), an audio output device (such as a speaker, etc.), a vibration device, etc. The one or more user interface elements 206 may also include one or more input elements, such as buttons, knobs, touch screens or panels, etc. In some cases, the one or more user interface elements 206 may include a delivery button that can be actuated by a user to trigger the drive mechanism 220, thereby delivering the expected dose of the drug via the cartridge 20. In some cases, the one or more user interface elements 206 may include an eject button that can be actuated by a user to trigger the eject mechanism, thereby ejecting the cartridge 20 from the housing. A suitable delivery button or eject button may be a touch-sensitive button that is functionally coupled to the control circuit 210, thereby sending a corresponding actuation signal to the control circuit 210 according to different actions of the user.

[0052] The control circuit 210 is coupled to the communication interface 202, the memory 204, the sensing and actuation assembly 208, and one or more user interface elements 206. The control circuit 210 is configured to support the operation, tasks, and / or processes of the drug delivery device described herein. For example, the control circuit 210 supports the operation of the sensing and actuation assembly 208 in response to user instructions from one or more user interface elements 206, thereby delivering a predetermined dose of the drug to the user via the cartridge 20 with a needle attached. According to this embodiment, the control circuit 210 can be implemented or realized with a general-purpose processor, a microprocessor, a controller, a microcontroller, a state machine, a content addressable memory, an application-specific integrated circuit, a field programmable gate array, any suitable programmable logic device designed to perform the functions described herein, a discrete gate or transistor logic component, a discrete hardware component, or any combination thereof. In this regard, the steps of the method or algorithm described in conjunction with the embodiments disclosed herein can be directly embodied in hardware, firmware, a software module executed by the control circuit 210, or any practical combination thereof.

[0053] In various embodiments, the control circuit 210 may also include or have access to a memory 204, which may include any suitable non-transitory computer-readable medium capable of storing programming instructions for execution by the control circuit 210. The computer-executable programming instructions, when read and executed by the control circuit 210, cause the control circuit 210 to perform the tasks, operations, functions, and processes described herein.

[0054] Various embodiments of drug delivery devices are provided for Figure 1The drug delivery device 110 and Figure 2 A drug delivery device 200 is provided. Figure 3 300 is a perspective view of a drug delivery device according to one embodiment. The drug delivery device 300 includes a housing 10 extending in a longitudinal direction between a first end 11 and a second end 13 thereof. The housing 10 defines an interior space to receive a cartridge 20 via an opening 15 at the first end 11 of the housing 10. Figure 3 As shown, the cartridge 20 is inserted into the housing 10 longitudinally as indicated by the arrow via the opening 15 at the first end 11 of the housing 10. In some cases, the entire body of the cartridge 20 can be positioned within the housing 10, and the distal end 21 of the cartridge 20 can be accessed from the opening 15 for the user to install a needle thereon. In some cases, the main body portion of the cartridge 20 can be positioned inside the housing 10, and the distal end 21 protrudes outside the housing 10 through the opening 15. Figure 3 In the illustrated embodiment, the housing 10 may have an integral structure that may be formed by a plurality of components assembled together. In some embodiments, the housing 10 may have a first portion located at the first end 11 and a second portion located at the second end 13, and the first portion and the second portion may be engaged with each other by an engagement mechanism (e.g., a threaded mechanism). The cartridge may be loaded into the first and / or second portion and ejected via an ejection mechanism (e.g., a spring-loaded bayonet mechanism).

[0055] The drug delivery device 300 also includes a display panel 12 disposed on an outer surface of the housing 10. The display panel 12 may include a display to present various information to the user, including, for example, analyte measurement data (e.g., continuous glucose monitor (CGM) data, rapid glucose monitor data, blood glucose meter data, etc.), inquiries to the user requesting the user to input therapy-related conditions, indicators or icons representing therapy-related conditions (e.g., meal size, exercise plan, etc.), warnings for blood glucose measurement values ​​outside a predetermined range, inquiries indicating whether the user needs to manually adjust the expected dose, indications that the drug delivery device has received a user-input dose from an auxiliary device, instructions for the user to start the drug delivery device before automatically delivering the expected dose, and the like.

[0056] The display panel 12 may be part of a user interface (UI) of the drug delivery device 300 for a user to interact and communicate with the drug delivery device 300. The display panel 12 may also include a touch screen, one or more touch buttons, one or more smart sensors for detecting user actions (e.g., finger touches), or other input mechanisms for receiving user input. The one or more touch buttons on the touch screen may include, for example, an injection button, an eject button. It should be understood that the one or more touch buttons on the touch screen may be touch buttons disposed on the outer surface of the housing 10. For example, Figure 5AIn the illustrated embodiment, the drug delivery device 300 includes an injection button 14 and an ejection button 18 disposed on an outer surface of the housing 10 .

[0057] Figure 4A is a side perspective view of drug delivery device 300 . Figure 4B is a first end view of drug delivery device 300 . Figure 4C FIG. 4 is a second end view of the drug delivery device 300. Figure 4A As shown, the entire body of the cartridge 20 is located within the housing 10, with its distal end 21 recessed from the edge surface 111 at the first end 11 of the housing 10. The distal end 21 is accessible from the opening 15 for the user to mount a needle thereon. It should be understood that the housing 10 can be configured to receive barrels of different lengths.

[0058] like Figure 4B As shown, the drug delivery device 300 includes one or more skin sensors 16 disposed on an edge surface 111 at the first end 11 of the housing 10. The skin sensor 16 is configured to detect the user's skin when the edge surface 111 of the first end 11 of the housing 10 is in close contact with the user's skin. In some cases, the skin sensor 16 may include one or more capacitive sensors disposed on the edge surface 111, which are configured to measure information generated by the proximity interaction between the edge surface 111 and the user's skin. Figure 4B A pair of skin sensors are shown in the figure, but it should be understood that one or more skin sensors 16 can be located at the first end 11 of the shell to detect the proximity of the skin. In some cases, the sensing data from multiple skin sensors can be used to detect the orientation of the shell 10 relative to the user's skin. For example, when the shell 10 is tilted at a certain angle so that the needle does not penetrate the skin straight, the skin sensor 16 can sense the angle and send a signal indicating that the orientation needs to be adjusted. When the edge surface 111 and the user's skin are in close contact with each other and the orientation is in an acceptable position, the skin sensor 16 can send a signal to indicate that the drug delivery device 300 is in an acceptable position for drug delivery. In some embodiments, the drug delivery device 300 may also include one or more accelerometers to determine the insertion angle of the needle relative to the user's skin surface.

[0059] like Figure 4C As shown, the drug delivery device 300 includes an ejection button 18 located at the second end 13 to allow a user to push to disengage and eject the cartridge 20 from the drug delivery device 300. A charging port 172 is also provided to allow a user to charge a battery (e.g., Figure 5A The charging port 172 may have a battery charging specification according to various industry standards (eg, the Universal Serial Bus (USB) industry standard).

[0060] Figure 5A is a cross-sectional view of drug delivery device 300 . Figure 5B yes Figure 5A A cross-sectional view of a portion of a drug delivery device 300. The housing 10 of the drug delivery device 300 defines an internal space 19 to accommodate a cartridge 20. The cartridge 20 extends between a distal end 21 and a proximal end 23 in a longitudinal direction. The cartridge 20 includes a vial 20a having a septum at the distal end 21. The cartridge 20 contains a plurality of doses of a drug and includes a displacement member 22 at least partially disposed inside the vial 20a of the cartridge 20 and between the proximal end 23 and the distal end 21. The displacement member 22 can be moved from the proximal end 23 to the distal end 21 in a longitudinal direction of the cartridge 20 to deliver the drug from the distal end 21 of the cartridge 20. Figure 5A In the illustrated embodiment, the displacement member 22 is a plunger. The vial 20a of the cartridge 20 can have a transparent or translucent wall so that the user can observe the medicine in the vial 20a. Size / dose markings can be provided on the vial wall. The trade name of an exemplary insulin cartridge is NovoLog, which can be commercially available from Novo Nordisk A / S (Bagsvaerd, Denmark), and the trade name is HUMALOG, which can be commercially available from Eli Lilly and Company (Indianapolis, Indiana).

[0061] The drug delivery device 300 further includes a drive mechanism 32 disposed at an end of the interior space 19 opposite the opening 15. The drive mechanism 32 is mechanically connected to the advancement member 34 and is configured to move the advancement member 34 toward the opening 15 in a longitudinal direction. Figure 5A In the illustrated embodiment, the advancement member 34 is a piston. The piston 34 includes a piston rod 342 mechanically coupled to the drive mechanism 32 and a pressure block 344 engaged with the displacement member 22 (e.g., plunger) of the cartridge 20, so that when the cartridge 20 is accommodated in the housing 10 of the drug delivery device 300, the plunger 22 is advanced in the cartridge 20. It should be understood that the advancement member 34 of the drug delivery device 300 can have any suitable configuration other than a piston.

[0062] The drug delivery device 300 also includes one or more position sensors 42, which are positioned to detect the position of the advancement member 34 or the displacement member 22 in the cartridge 20. For example, when the advancement member 34 (e.g., piston) advances the displacement member 22 (e.g., plunger) at any point along the longitudinal direction between the proximal end 23 and the distal end 21, the position sensor 42 can emit an optical signal to the cartridge 20 and collect the optical signal reflected or transmitted from the cartridge 20. The position sensor 42 is installed inside the housing 10, facing the cartridge 20. In some embodiments, an array of position sensors 42 is arranged between the proximal end 23 and the distal end 21 of the cartridge 20 along the longitudinal direction of the housing 10 to detect the position of the advancement member 34 or the displacement member 22 in the cartridge 20.

[0063] The drug delivery device 300 also includes a printed circuit board assembly (PCBA) 17, which may include various control circuits or electronic components, such as logic circuits, drive controller circuits, wireless communication circuits, memory, etc. The printed circuit board assembly (PCBA) 17 is supported by the housing 10, powered by a battery 174, and functionally connected to other components of the drug delivery device 300, such as the drive mechanism 32, the skin sensor 16, the display 12, etc. The control circuit is configured to execute one or more algorithms stored in the memory to determine the expected dose of the drug to be delivered.

[0064] The control circuit is also configured to obtain information from the one or more position sensors 42 that indicates the position of the advancement member 34 or the displacement member 22 within the cartridge 20. The control circuit may execute one or more algorithms to determine a first position of the displacement member 22 within the cartridge 20 based on the information from the one or more position sensors 42. The first position determines the position of the displacement member 22 prior to delivery of a dose of medication.

[0065] In some embodiments, one or more position sensors 42 can detect a signal when a new cartridge is received by the housing 10. After receiving the signal from the position sensor 42, the control circuit can generate and present to the user an instruction to start the drug delivery device. After starting the device, the one or more position sensors 42 can obtain information indicating the position of the advancement member 34 or the displacement member 22 within the cartridge 20 for the control circuit to determine whether the device is properly started. After determining that the device is properly started, the control circuit can determine the first position of the displacement member 22 before delivering a dose of the drug.

[0066] Using the determined first position, the control circuit can determine a second position of the advancement member 34 or displacement member 22 within the drug device based on an expected dose of drug expected to be delivered. The second position indicates a desired position of the advancement member 34 or displacement member 22 within the cartridge 20 after a dose of drug is delivered.

[0067] With the first and second positions determined, the control circuit can instruct 32 to advance the displacement member 22 from the determined first position, and after obtaining information from one or more position sensors 42 indicating that the advancement member 34 or the displacement member 22 has reached the second position, instruct 32 to stop advancing the displacement member 22.

[0068] After delivering a certain dose of medicine, the control circuit is also configured to determine the third position of the forward member 34 or the displacement member 22 in the cartridge 20 after the displacement member 22 has stopped moving forward based on the message from the one or more position sensors 42. The control circuit is also configured to determine the actual dose of medicine delivered based on the first position and the third position of the forward member 34 or the displacement member 22 in the cartridge 20. The actual dose refers to the amount of medicine delivered from the cartridge 20 after the displacement member 22 stops moving forward. The control circuit can compare the actual dose with the expected dose. When the actual dose is different from the expected dose, the control circuit can execute one or more algorithms to calculate the active insulin (IOB) value based on the actual dose, and calculate the subsequent expected dose for the next scheduled time based on the calculated IOB value.

[0069] Automatically deliver medicines to users

[0070] Figure 6 6 is a flow chart of a method 600 for delivering a drug using a drug delivery device according to one embodiment. The drug delivery device includes one or more user interface elements, control circuitry, and memory. It should be understood that the method 600 can be implemented by any drug delivery and management system and / or any drug delivery device described herein, such as by Figure 1 The drug delivery and management system 100 of the illustrated embodiment and Figure 2-5B This can be achieved by using the drug delivery devices 200, 300, etc. shown in FIG.

[0071] At 610, a drug delivery device receives analyte measurement data from a user. The drug delivery device may include a wireless communication component to communicate with an analyte sensor system (such as Figure 1 The method 600 may further include receiving analyte measurement data from the analyte sensor system 102 shown in the figure. For example, in some embodiments, the drug delivery device may receive blood glucose data (e.g., current blood glucose level) or blood glucose trend data (e.g., rate of change of blood glucose level) from a blood glucose sensor system. The method 600 then proceeds to 620.

[0072] At 620, the drug delivery device presents information related to the analyte measurement data to the user via one or more user interface elements. For example, in some embodiments, when the drug delivery device determines that the received blood glucose data or trend data exceeds a predetermined standard, the drug delivery device can generate an alarm or warning to present to the user on the user interface element. In some embodiments, when the drug delivery device determines that the received blood glucose data or trend data is within the predetermined standard, the drug delivery device can present the received blood glucose data and / or trend data to the user on the user interface element without triggering an alarm or warning. The method 600 then proceeds to 630. Figure 8 An example user interface 810 of a drug delivery device is shown, including a graphical presentation of blood glucose data 811 and / or blood glucose trend data 812 on its display or touch screen 802. The trend data 812 includes a series of blood glucose data along an axis representing time. The user interface 810 also includes a virtual touch button 813 on the touch screen 802 for receiving a user's input 816 (e.g., by pressing and holding a user's finger) to display data. The touch screen 802 can be configured to receive a user's input 817 (e.g., by sliding a user's finger) to change the graphical presentation of blood glucose data 811 and / or blood glucose trend data 812. The user interface 810 also includes a graphical presentation of a notification 814 about the displayed blood glucose data 811 and / or trend data 813.

[0073] At 630, the drug delivery device determines an expected dose of the drug based on the received analyte measurement data. In some embodiments, the expected dose can be determined or adjusted based on one or more therapy-related conditions, one or more therapy parameters stored in a memory of the drug delivery device, or a calculated insulin active (IOB) value. The method 600 then proceeds to 640.

[0074] The one or more therapy-related conditions may include, for example, at least one of meal size, sleep schedule, exercise schedule, etc. The one or more therapy parameters may include, for example, daily dose of long-acting insulin, doses for different meal sizes or meal categories, insulin sensitivity factor, carbohydrate to insulin ratio, etc. In some embodiments, the drug delivery device may present a query to the user via one or more user interface elements to request the user to input one or more therapy-related conditions.

[0075] In some embodiments, the content of the inquiry and the timing of presenting the inquiry to the user can be determined based on the user's personalized pattern data. The personalized pattern data may include the user's lifestyle factor data or historical data related to, for example, the user's meal times of the day, the user's medication delivery times of the day, the user's exercise times of the day, the user's sleep times of the day, analyte measurement data (e.g., blood glucose levels) in response to different treatment-related conditions input by the user, actual dosage data, etc. The lifestyle factor data or historical data can be stored in a memory of the drug delivery device. The drug delivery device may include an analysis engine implemented by the control circuit of the drug delivery device to analyze the user's lifestyle factor data or historical data, thereby determining the content of the inquiry and the timing (e.g., time of day) of presenting the inquiry to the customer on the user interface element based on the user's personalized pattern data. It should be understood that the analysis engine can be implemented by a drug delivery and management system (such as Figure 1 The invention can be implemented by any computing device / component of the embodiment 100 shown in the figure, etc., so as to execute one or more algorithms to analyze personalized pattern data and determine the query. Exemplary patient pattern data are described in U.S. Patent Nos. 10,426,896, 11,083,852, 10,456,090 and PCT Publication No. WO / 2021 / 072437, which are incorporated herein by reference.

[0076] The one or more therapy parameters may include, for example, daily dose of long-acting insulin, doses for different meal sizes or meal categories, insulin sensitivity factor, carbohydrate to insulin ratio, etc. In some embodiments, therapy parameters for a particular user may be stored in a memory of the drug delivery device. The drug delivery device may receive a message from a mobile application (e.g., Figure 1 The mobile application 104 of the illustrated embodiment, etc.) receives updates on one or more therapy parameters.

[0077] In some embodiments, one or more algorithms may be provided by a mobile application via a secondary device such as Figure 1 106 of the embodiment shown), or via a network (such as Figure 1 The mobile application can automatically deliver the updated therapy parameters to the drug delivery device. In some embodiments, the therapy parameters can be updated by a healthcare professional or manually updated by a user or a caregiver. In some embodiments, the drug delivery device can include an algorithm in a memory that is executed by a processor to automatically update the therapy parameters. In some embodiments, the drug delivery device can receive user input via one or more user interface elements to confirm the update of one or more therapy parameters.

[0078] In some embodiments, the system can be connected to the auxiliary device (e.g., Figure 1 The user interface of the auxiliary device 106, etc. in the device 106a asks the user whether it is necessary to update one or more therapy-related conditions, one or more therapy parameters, and / or manually adjust the expected dose determined by the drug delivery device.

[0079] At 640 , the drug delivery device asks the user if the user is ready to deliver without presenting the expected dose on any of the one or more user interface elements of the drug delivery device. Method 600 then proceeds to 650 .

[0080] In some embodiments, the drug delivery device may include one or more skin sensors positioned to determine the relative position of the drug delivery device with respect to the user's skin when the drug delivery device is seated on the user's skin for drug delivery. The control circuitry of the drug delivery device may receive skin sensing data from the skin sensors and execute one or more algorithms to determine whether the drug delivery device is in an acceptable position and orientation on the user's skin for drug delivery, and generate a corresponding query to be presented on one or more user interface elements to inquire whether the user is ready for delivery or needs to make any adjustments.

[0081] In some embodiments, the user can use an auxiliary device (such as Figure 1 The device may further include a secondary device 106, etc.) to access and / or adjust the expected dose before querying the user at 640. After receiving the user input dose from the secondary device, the drug delivery device may present (e.g., display) via at least one user interface element thereof an indication that the drug delivery device has received the user input dose from the secondary device and query the user whether the user is ready to deliver the user input dose.

[0082] At 650, the drug delivery device automatically delivers a dose of drug based on the expected dose determined at 630 after receiving a confirmation indication from the user. When the user receives an indication from a user interface element of the drug delivery device that the drug is ready for delivery, the user may engage a user interface element (such as a delivery button, etc.) to trigger the device to deliver the dose of drug. It should be understood that while the drug delivery device attempts to deliver a dose based on the expected dose automatically determined by the drug delivery device at 630, the actual dose delivered to the user may be different from the expected dose for various reasons. Embodiments of drug delivery devices and methods are provided to control a device to deliver a dose based on the expected dose, determine an actual dose of drug after delivery, calculate an active insulin (IOB) value based on the actual dose, and determine a subsequent expected dose for the next scheduled time based on the calculated IOB value.

[0083] Figure 7is a flow chart of a method 700 for delivering a drug using a drug delivery device according to another embodiment, the drug delivery device including a housing configured to accommodate a cartridge. A suitable cartridge extends between a distal end and a proximal end thereof, and includes a vial having a diaphragm at the distal end and a displacement member within the vial, the displacement member being movable from the proximal end to the distal end to deliver the drug contained in the vial from the distal end. A suitable drug delivery device for use herein includes a drive mechanism within the housing, the drive mechanism being used to move the displacement member forward within the cartridge to deliver the drug when the cartridge is accommodated in the housing. The drug delivery device also includes one or more position sensors positioned to detect the position of the displacement member within the cartridge, and a control circuit configured to control the operation of the drug delivery device. It should be understood that the method 600 may be implemented by any drug delivery and management system and / or any drug delivery device described herein, such as by Figure 1 The drug delivery and management system 100 and Figure 2-5B This is achieved by using drug delivery devices 200, 300, etc.

[0084] At 710, the control circuitry of the drug delivery device determines an expected dose of the drug to be delivered. The expected dose of the drug may be determined based on the received analyte measurement data. In some embodiments, the expected dose may be determined or adjusted based on one or more therapy-related conditions, one or more therapy parameters stored in a memory of the drug delivery device, or a calculated insulin active (IOB) value. The control circuitry of the drug delivery device may determine the expected dose of the drug to be delivered by any suitable method described herein (such as Figure 6 630 of method 600, etc.) to determine the expected dose.

[0085] At 720, one or more position sensors of the drug delivery device detect the position of the displacement member within the cartridge and provide information indicative of the position of the cartridge to the control circuit. Figure 5A In the illustrated embodiment, one or more position sensors 42 of the drug delivery device 300 are positioned to detect the position of the advancement member 34 or displacement member 22 within the cartridge 20 and provide information indicative of the position of the cartridge 20 to the control circuit 17 .

[0086] At 730, the control circuitry of the drug delivery device obtains information from one or more position sensors indicating the position of the displacement member within the cartridge. Figure 5A In the illustrated embodiment, the control circuit 17 of the drug delivery device 300 is further configured to obtain information indicative of the position of the advancement member 34 or the displacement member 22 within the cartridge 20 from the one or more position sensors 42 .

[0087] At 740, the control circuitry of the drug delivery device determines that the displacement member is in a first position within the cartridge based on the information from the one or more position sensors obtained at 730. The first position represents the position of the displacement member before the drug dose is delivered. For example, Figure 5A In the illustrated embodiment, control circuitry 17 of drug delivery device 300 may execute one or more algorithms stored in memory to determine a first position of advancement member 34 or displacement member 22 within cartridge 20 based on information obtained from one or more position sensors 42 at 730 .

[0088] At 750, the control circuitry of the drug delivery device determines a second position of the displacement member within the drug device based on the expected dose of drug to be delivered. The second position indicates a desired position of the displacement member within the cartridge after a dose of drug is delivered. For example, Figure 5A In the illustrated embodiment, control circuitry 17 of drug delivery device 300 may execute one or more algorithms stored in memory to determine a second position of advancement member 34 or displacement member 22 within cartridge 20 based on an expected dose of drug to be delivered.

[0089] At 760, the control circuit of the drug delivery device instructs the displacement member to move forward from the first position. Figure 5A In the illustrated embodiment, control circuitry 17 of drug delivery device 300 may instruct 32 to advance advancement member 34 or displacement member 22 from the first position.

[0090] At 765, the control circuitry of the drug delivery device obtains information about the position of the displacement member from the position sensor. For example, Figure 5A In the illustrated embodiment, when the drive mechanism 32 advances the displacement member 22 via the advancement member 34 , the control circuit 17 of the drug delivery device 300 can obtain information about the position of the advancement member 34 or the displacement member 22 within the cartridge 20 from the position sensor 42 .

[0091] At 770, the control circuit of the drug delivery device instructs to stop advancing the displacement member after obtaining information from one or more position sensors indicating that the displacement member has reached the second position. Figure 5A In the illustrated embodiment, control circuitry 17 of drug delivery device 300 instructs 32 to stop advancing displacement member 22 after obtaining information from one or more position sensors 42 indicating that advancement member 34 or displacement member 22 has reached the second position.

[0092] At 775, after a dose of the drug is delivered, the control circuit determines a third position of the displacement member within the cartridge after the displacement member has stopped advancing based on information from the one or more position sensors. Figure 5AIn the illustrated embodiment, the control circuit 17 executes one or more algorithms stored in memory to determine a third position of the advancement member 34 or the displacement member 22 within the cartridge 20 after the advancement member 34 or the displacement member 22 has stopped moving forward based on information from the one or more position sensors 42.

[0093] At 780, the control circuit determines the actual dose of drug delivered based on the first position and the third position of the displacement member within the cartridge. Figure 5A In the illustrated embodiment, the control circuit 17 executes one or more algorithms stored in the memory to determine the actual dose of the drug delivered based on the first position and the third position of the advancement member 34 or the displacement member 22 in the cartridge 20. In some embodiments, the control circuit can compare the actual dose with the expected dose. When the actual dose is different from the expected dose, the control circuit can execute one or more algorithms to calculate the active insulin (IOB) value based on the actual dose, and calculate the subsequent expected dose for the next scheduled time based on the calculated IOB value.

[0094] Multiple aspects:

[0095] It should be understood that any aspect may be combined with any other aspect.

[0096] Aspect 1 is a method of delivering a drug using a drug delivery device, the drug delivery device comprising one or more user interface elements, a control circuit, and a memory, the method comprising:

[0097] receiving analyte measurement data of a user via a drug delivery device;

[0098] presenting information related to the analyte measurement data to a user via one or more user interface elements;

[0099] determining an intended dosage of a drug product based on the analyte measurement data;

[0100] Asking a user whether they are ready for drug delivery without presenting the intended dose on any of the one or more user interface elements of the drug delivery device; and automatically delivering the intended dose upon receipt of a confirmation indication from the user.

[0101] Aspect 2 is the method of aspect 1, wherein the expected dose is further determined based on at least one of: one or more therapy-related conditions, one or more therapy parameters stored in a memory of the drug delivery device, and a calculated active insulin dosage (IOB) value.

[0102] Aspect 3 is the method described in aspect 1 or 2, further comprising receiving a user input dose via a user interface of an auxiliary device, the user input dose representing a dose amount or adjustment of an intended dose, wherein the auxiliary device wirelessly communicates with the drug delivery device to transmit the received user input dose to the drug delivery device.

[0103] Aspect 4 is the method of aspect 3, further comprising displaying, via at least one of the one or more user interface elements of the drug delivery device, an indication that the drug delivery device has received a user-input dose from the auxiliary device.

[0104] Aspect 5 is the method of aspect 4, further comprising asking the user whether the user is ready for delivery of the user-input dose, and automatically delivering the user-input dose after receiving a confirmation indication from the user.

[0105] Aspect 6 is the method of any one of aspects 3 to 5, further comprising asking a user via a user interface of the auxiliary device whether manual adjustment of the expected dose is desired.

[0106] Aspect 7 is the method of any of aspects 1-6, further comprising presenting a query to the user via one or more user interface elements at a predetermined time to request the user to input one or more therapy-related conditions.

[0107] Aspect 8 is the method of aspect 7, further comprising determining the query based on the user's personalized pattern data.

[0108] Aspect 9 is the method of any of aspects 2-8, further comprising updating one or more therapy parameters based on at least one of: one or more previously stored therapy parameters and previous analyte measurement data, dosage data, and meal data.

[0109] Aspect 10 is the method of aspect 9, further comprising receiving an update of one or more therapy parameters from the mobile application via the wireless communication component of the drug delivery device.

[0110] Aspect 11 is the method of aspect 9 or 10, further comprising receiving user input via one or more user interface elements to confirm the update of one or more therapy parameters.

[0111] Aspect 12 is the method of any one of aspects 1-11, further comprising determining an actual dose of the drug after the intended dose is delivered.

[0112] Aspect 13 is the method of aspect 12, further comprising comparing the actual dose with the expected dose, calculating an active insulin (IOB) value based on the actual dose when the actual dose is different from the expected dose, and calculating a subsequent expected dose at the next scheduled time based on the calculated IOB value.

[0113] Aspect 14 is the method of any of aspects 1-13, wherein asking the user whether they are ready includes presenting instructions to the user to activate the drug delivery device prior to automatically delivering the intended dose.

[0114] Aspect 15 is a drug delivery device, comprising:

[0115] a housing configured to house a cartridge extending between a distal end and a proximal end thereof and including a vial having a septum at the distal end and a displacement member located inside the vial, the displacement member being movable from the proximal end to the distal end to deliver a drug contained in the vial from the distal end;

[0116] a drive mechanism located inside the housing and configured to advance the displacement member within the cartridge to deliver the drug when the cartridge is received in the housing;

[0117] one or more position sensors positioned to detect the position of the displacement member within the cartridge when the cartridge is received in the housing; and

[0118] A control circuit configured to:

[0119] Determine the expected dose of drug to be delivered,

[0120] obtaining information from one or more position sensors indicating the position of the displacement member within the cartridge,

[0121] determining a first position of the displacement member within the cartridge based on information from the one or more position sensors, wherein the first position represents a position of the displacement member prior to delivery of a dose of the drug,

[0122] determining a second position of the displacement member within the medical device based on an expected dose of the drug to be delivered, the second position being indicative of a desired position of the displacement member within the cartridge after delivery of a dose of the drug,

[0123] instructing the displacement member to move forward from the first position, and

[0124] After obtaining information from the one or more position sensors indicating that the displacement member has reached the second position, the drive mechanism is instructed to stop advancing the displacement member.

[0125] Aspect 16 is the drug delivery device of aspect 15, wherein after delivering a dose of the drug, the control circuit is configured to:

[0126] determining a third position of the displacement member within the cartridge after the displacement member stops advancing based on information from the one or more position sensors, and

[0127] An actual dose of the drug delivered is determined based on the displacement member being in the first position and the third position within the cartridge.

[0128] Aspect 17 is the drug delivery device of aspect 15 or 16, further comprising a button for triggering the drive mechanism.

[0129] Aspect 18 is the drug delivery device of aspect 15, further comprising a skin sensor positioned at the distal end of the housing to detect the skin.

[0130] Aspect 19 is the drug delivery device of aspect 15, further comprising a wireless communication component configured to receive analyte measurement data from the analyte sensor system.

[0131] Aspect 20. The drug delivery device of Aspect 19, wherein the analyte measurement data comprises at least one of: continuous glucose monitor (CGM) data, rapid glucose monitor data, or blood glucose meter data.

[0132] Aspect 21 is the drug delivery device of aspect 19, wherein the wireless communication component is configured to receive one or more therapy parameters from the mobile application.

[0133] Aspect 22 is the drug delivery device of aspect 21, wherein the one or more therapy parameters include at least one of the following: daily dose of long-acting insulin, doses for different meal sizes, insulin sensitivity factor, or carbohydrate to insulin ratio.

[0134] Aspect 23 is the drug delivery device of aspect 15, further comprising one or more user interface elements for displaying analyte measurement data to a user.

[0135] Aspect 24 is the drug delivery device of aspect 15, further comprising one or more user interface elements for presenting a query to request user input of one or more therapy-related conditions.

[0136] Aspect 25 is the drug delivery device of aspect 24, wherein the one or more therapy-related conditions include at least one of: meal size or exercise program.

[0137] Aspect 26 is the drug delivery device of Aspect 15, which is a smart insulin injection pen.

[0138] Aspect 27 is a method of delivering a drug using a drug delivery device, the drug delivery device comprising a housing configured to accommodate a cartridge, the cartridge extending between a distal end and a proximal end thereof and comprising a vial having a septum at the distal end, the drug delivery device further comprising a drive mechanism within the housing, one or more position sensors positioned to detect a position of a displacement member within the cartridge, and a control circuit configured to control operation of the drug delivery device, wherein the drive mechanism is configured to advance a displacement member within the cartridge when the cartridge is accommodated in the housing to deliver the drug, the method comprising:

[0139] The control circuit determines the intended dose of drug to be delivered;

[0140] One or more position sensors detect the position of the displacement member within the cartridge and provide information indicative of the cartridge position to the control circuit;

[0141] The control circuit obtains information indicative of the position of the displacement member within the cartridge from one or more position sensors;

[0142] the control circuitry determining a first position of the displacement member within the cartridge based on information from the one or more position sensors, wherein the first position represents a position of the displacement member prior to delivery of a dose of the drug;

[0143] the control circuit also determining a second position of the displacement member within the medical device based on an expected dose of the drug to be delivered, the second position indicating a desired position of the displacement member within the cartridge after delivery of the dose of the drug;

[0144] The control circuit instructs the displacement member to move forward from the first position; and

[0145] The control circuit instructs to stop the displacement member from moving forward after obtaining information from the one or more position sensors indicating that the displacement member has reached the second position.

[0146] Aspect 28 is the method of aspect 27, further comprising

[0147] After delivery of the dose of medication, the control circuit determines, based on information from the one or more position sensors, that the displacement member is in a third position within the cartridge after the displacement member stops advancing; and

[0148] The control circuit determines an actual dose of drug delivered based on the displacement member being in the first position and the third position within the cartridge.

[0149] Aspect 29 is the method of aspect 28, further comprising comparing the actual dose with the expected dose, calculating an active insulin (IOB) value based on the actual dose when the actual dose is different from the expected dose, and calculating a subsequent expected dose for the next scheduled time based on the calculated IOB value.

[0150] Aspect 30 is the method of aspect 27, further comprising receiving analyte measurement data from the analyte sensor system via the wireless communication component.

[0151] Aspect 31 is the method of aspect 30, wherein the analyte measurement data comprises at least one of: continuous glucose monitor (CGM) data, rapid glucose monitor data, or blood glucose meter data.

[0152] Aspect 32 is the method of aspect 27, further comprising receiving one or more therapy parameters from the mobile application via the wireless communication component.

[0153] Aspect 33 is the method of aspect 32, wherein the one or more therapy parameters include at least one of the following: daily dose of long-acting insulin, dose for different meal sizes, insulin sensitivity factor, or carbohydrate to insulin ratio.

[0154] Aspect 34 is the method of aspect 27, further comprising presenting a query to the user via the user interface to request the user to input one or more therapy-related conditions.

[0155] Aspect 35 is the method of aspect 34, wherein the one or more therapy-related conditions include at least one of: meal size or exercise program.

[0156] Aspect 36 is the method of aspect 27, further comprising displaying the analyte measurement data to a user via a user interface of the drug delivery device.

[0157] Aspect 37 is the method of aspect 36, further comprising displaying, via the user interface, a warning for blood glucose measurement values ​​outside a predetermined range.

[0158] Aspect 38 is the method of aspect 27, further comprising detecting the user's skin via a skin sensor to determine the relative position of the distal end of the device relative to the user's skin.

[0159] Aspect 39 is the method of Aspect 27, wherein the expected dose of the drug is determined based on at least one of: analyte measurement data, optionally one or more therapy-related conditions, one or more parameters stored in a memory of a drug delivery device, or a calculated active insulin (IOB) value.

[0160] Aspect 40 is the method of aspect 27, further comprising receiving input from a user via the user interface, the input indicating that the user is ready for delivery.

[0161] The terms used in this specification are intended to describe specific embodiments and are not intended to be limiting. Unless otherwise expressly stated, the terms "a", "an", and "said / the" also include plural forms. When used in this specification, the terms "include" and / or "comprise" specify the presence of stated features, wholes, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, and / or components.

[0162] With respect to the foregoing description, it should be understood that changes in detail may be made without departing from the scope of the present disclosure, especially in the construction materials adopted and the shapes, sizes and arrangements of the components. This specification and the described embodiments are exemplary only, and the true scope and connotation of the present disclosure are indicated by the appended claims.

Claims

1. A method for delivering a drug using a drug delivery device, the drug delivery device comprising one or more user interface elements, control circuitry, and memory, the method comprising: receiving analyte measurement data of a user via the drug delivery device; presenting information related to the analyte measurement data to the user via the one or more user interface elements; determining an expected dosage of a drug based on the analyte measurement data; asking the user whether the user is ready for drug delivery without presenting the expected dose on any of one or more user interface elements of the drug delivery device; and After receiving a confirmation indication from the user, the desired dose is automatically delivered.

2. The method of claim 1, wherein: The expected dose is also determined based on at least one of: one or more therapy related conditions, one or more therapy parameters stored in a memory of the drug delivery device, and a calculated active insulin IOB value.

3. The method of claim 1 , further comprising receiving a user input dose via a user interface of an auxiliary device, the user input dose representing a dose amount or adjustment of the expected dose, wherein The supplemental device wirelessly communicates with the drug delivery device to transmit the received user input dose to the drug delivery device.

4. The method of claim 3, further comprising displaying, via one or more user interface elements of the drug delivery device, an indication that the drug delivery device has received the user-input dose from the auxiliary device.

5. The method of claim 4, further comprising querying the user whether the user is ready for delivery of the user-input dose, and automatically delivering the user-input dose upon receiving a confirmation indication from the user.

6. The method of claim 3, further comprising asking the user via a user interface of the auxiliary device whether manual adjustment of the intended dose is desired.

7. The method of claim 1, further comprising presenting a query to a user via the one or more user interface elements at a predetermined time to request the user to input one or more therapy-related conditions.

8. The method of claim 7, further comprising determining the query based on personalized pattern data of the user.

9. The method of claim 2, further comprising updating the one or more therapy parameters based on one or more previously stored therapy parameters and one or more of previous analyte measurement data, dosage data, and meal data.

10. The method of claim 9, further comprising receiving updates of the one or more therapy parameters from a mobile application via a wireless communication component of the drug delivery device.

11. The method of claim 9, further comprising receiving user input via the one or more user interface elements to confirm the updating of the one or more therapy parameters.

12. The method of claim 1, further comprising determining an actual dose of the drug after delivering the expected dose.

13. The method of claim 12, further comprising comparing the actual dose with the expected dose, calculating an active insulin IOB value based on the actual dose when the actual dose is different from the expected dose, and calculating a subsequent expected dose for a next scheduled time based on the calculated IOB value.

14. The method of claim 1, wherein asking the user whether they are ready comprises: Prior to automatically delivering the desired dose, the user is presented with instructions to activate the drug delivery device.

15. A drug delivery device comprising: a housing configured to house a cartridge extending between a distal end and a proximal end thereof and comprising a vial having a septum at the distal end and a displacement member located inside the vial, the displacement member being movable from the proximal end to the distal end to deliver a drug contained in the vial from the distal end; a drive mechanism located inside the housing, the drive mechanism being configured to advance the displacement member within the cartridge to deliver a drug when the cartridge is received in the housing; one or more position sensors positioned to detect the position of the displacement member within the cartridge when the cartridge is received in the housing; and The control circuit is configured as follows: Determine the expected dose of drug to be delivered, acquiring information from the one or more position sensors, the information being indicative of the position of the displacement member within the cartridge, determining a first position of the displacement member within the cartridge based on information from the one or more position sensors, wherein the first position represents a position of the displacement member prior to delivery of the dose of medication, determining a second position of the displacement member within the medical device based on an expected dose of the medical product to be delivered, the second position representing a desired position of the displacement member within the cartridge after delivery of the dose of the medical product, instructing the drive mechanism to move the displacement member forward from the first position, and After obtaining information from the one or more position sensors indicating that the displacement member has reached the second position, the drive mechanism is instructed to stop advancing the displacement member.

16. The drug delivery device of claim 15, wherein: After delivering the drug dose, the control circuit is configured to: determining a third position of the displacement member within the cartridge after the displacement member stops advancing based on information from the one or more position sensors, and Based on the first position and the third position of the displacement member within the cartridge, an actual dose of drug delivered is determined.

17. The drug delivery device of claim 15, further comprising a button for activating the drive mechanism.

18. The drug delivery device of claim 15, further comprising a skin sensor positioned at a distal end of the housing to detect skin.

19. The drug delivery device of claim 15, further comprising a wireless communication component configured to receive analyte measurement data from the analyte sensor system.

20. The drug delivery device of claim 19, wherein the analyte measurement data comprises at least one of continuous glucose monitor (CGM) data, rapid glucose monitor data, or blood glucose meter data.

21. The drug delivery device of claim 19, wherein the wireless communication component is configured to receive one or more therapy parameters from a mobile application.

22. The drug delivery device of claim 21, wherein the one or more therapy parameters include at least one of: daily dose of long-acting insulin, doses for different meal sizes, an insulin sensitivity factor, or a carbohydrate to insulin ratio.

23. The drug delivery device of claim 15, further comprising one or more user interface elements for displaying analyte measurement data to a user.

24. The drug delivery device of claim 15, further comprising one or more user interface elements for presenting a query requesting the user to input one or more therapy-related conditions.

25. The drug delivery device of claim 24, wherein the one or more therapy-related conditions include at least one of meal size or exercise program.

26. The drug delivery device of claim 15, which is a smart insulin injection pen.

27. A method of delivering a drug using a drug delivery device, the drug delivery device comprising: A housing configured to accommodate a cartridge, the cartridge extending between a distal end and a proximal end thereof and comprising a vial having a septum at the distal end and a displacement member located within the vial, the displacement member being movable from the proximal end to the distal end to deliver the drug contained in the vial from the distal end, the drug delivery device further comprising: a drive mechanism located within the housing, the drive mechanism being configured to advance the displacement member within the cartridge to deliver the drug when the cartridge is accommodated in the housing; one or more position sensors positioned to detect the position of the displacement member within the cartridge; and a control circuit configured to control operation of the drug delivery device, the method comprising: The control circuit determines an expected dose of drug to be delivered; the one or more position sensors detecting the position of the displacement member within the cartridge and providing information indicative of the position of the cartridge to the control circuit; the control circuitry obtaining information indicative of the position of the displacement member within the cartridge from the one or more position sensors; the control circuitry determining a first position of the displacement member within the cartridge based on information from the one or more position sensors, wherein the first position represents a position of the displacement member prior to delivery of the dose of medication; the control circuit also determining a second position of the displacement member within the medical device based on an expected dose of the drug to be delivered, the second position representing a desired position of the displacement member within the cartridge after delivery of the dose of the drug; The control circuit instructs the drive mechanism to move the displacement member forward from the first position; and The control circuit instructs the drive mechanism to stop advancing the displacement member after obtaining information from the one or more position sensors indicating that the displacement member has reached the second position.

28. The method of claim 27, further comprising After delivering the dose of medicine, the control circuit determines, based on information from the one or more position sensors, a third position of the displacement member within the cartridge after the displacement member stops advancing; and The control circuit determines an actual dose of drug delivered based on the first and third positions of the displacement member within the cartridge.

29. The method of claim 28, further comprising comparing the actual dose with the expected dose, calculating an active insulin IOB value based on the actual dose when the actual dose is different from the expected dose, and calculating a subsequent expected dose for a next scheduled time based on the calculated IOB value.

30. The method of claim 27, further comprising receiving analyte measurement data from an analyte sensor system via a wireless communication component.

31. The method of claim 30, wherein the analyte measurement data comprises at least one of the following data: continuous glucose monitor (CGM) data, rapid glucose monitor data, or blood glucose meter data.

32. The method of claim 27, further comprising receiving one or more therapy parameters from a mobile application via the wireless communication component.

33. The method of claim 32, wherein the one or more therapy parameters include at least one of: daily dose of long-acting insulin, dose for different meal sizes, insulin sensitivity factor, or carbohydrate to insulin ratio.

34. The method of claim 27, further comprising presenting a query to the user via a user interface requesting the user to input one or more therapy-related conditions.

35. The method of claim 34, wherein the one or more therapy-related conditions include at least one of meal size or exercise program.

36. The method of claim 27, further comprising displaying analyte measurement data to a user via a user interface of the drug delivery device.

37. The method of claim 36, further comprising displaying, via the user interface, a warning for blood glucose measurement values ​​outside a predetermined range.

38. The method of claim 27, further comprising sensing a user's skin via a skin sensor to determine a relative position of a distal end of the device relative to the user's skin.

39. The method of claim 27, wherein the expected dose of the drug is determined based on at least one of: analyte measurement data, optionally one or more therapy-related conditions, one or more therapy parameters stored in a memory of the drug delivery device, or a calculated active insulin IOB value.

40. The method of claim 27, further comprising receiving input from a user via a user interface, the input indicating that the user is ready to deliver.

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