Drug Delivery Devices, Systems, and Methods

Abstract

A drug delivery method, device, and system are provided. The drug delivery device includes a user interface element, a control circuit, and a memory. The method includes receiving user's analyte measurement data, presenting information related to the analyte measurement data to the user, and determining a dosage of an intended drug based on the analyte measurement data, optionally, at least one of treatment related conditions, treatment parameters, or a calculated insulin on board (IOB) value. When the user is queried to indicate that the user is ready for delivery without presenting the dosage of the intended drug to any of the one or more user interface elements of the drug delivery device, the intended dosage is automatically delivered after receiving an instruction from the user.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 63 / 365,849, filed on June 3, 2023, and U.S. Patent Application No. 63 / 382,443, filed on November 4, 2022. The disclosures of the prior applications are considered part of the disclosure of this application and are hereby incorporated by reference in their entirety.

[0002] This disclosure generally relates to drug delivery devices and methods. More particularly, this disclosure relates to devices and methods for automatically delivering a desired dosage of a drug to a user without presenting the dosage to the user on any user interface of the drug delivery device.

Background Art

[0003] Diabetes treatment devices (e.g., glucose meters, insulin pumps, insulin injection devices, etc.) are widely used for patients with diabetes (PWD) to self - administer externally biologically active drugs (e.g., insulin or its analogs). Some diabetes treatment devices or mobile applications include an insulin bolus calculator to recommend insulin bolus administration to PWD. Typically, it is up to the patient to determine the actual amount of drug to be delivered.

Summary of the Invention

[0004] This disclosure generally relates to drug delivery devices and methods. More particularly, this disclosure relates to devices and methods for automatically delivering a desired dosage of a drug to a user without presenting the dosage to the user on any user interface of the drug delivery device.

[0005] Briefly, in one embodiment, this disclosure describes a method of 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 the user's analyte measurement data via a drug delivery device, presenting information related to the analyte measurement data to the user via one or more user interface elements, determining an intended dose of a drug based on at least one of the analyte measurement data, optionally one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, or a calculated insulin on board (IOB) value, querying the user to indicate that the user is ready to deliver the drug without presenting the intended dose on any of one or more user interface elements of the drug delivery device, and automatically delivering the intended dose after receiving an instruction from the user.

[0006] In another embodiment, the present disclosure describes a housing configured such that a drug delivery device receives a drug cartridge. The drug cartridge includes a vial extending between its distal end and proximal end and having a septum at the distal end, and a displacement member inside the vial and movable from the proximal end to the distal end to deliver the drug received by the vial from the distal end. The drug delivery device further includes a drive mechanism within the housing configured to advance the displacement member within the drug cartridge to deliver the drug when the drug cartridge is received within the housing, and one or more position sensors positioned to detect the position of the displacement member within the drug cartridge when the drug cartridge is received within the housing. The drug delivery device further includes a control circuit configured to determine an intended dose of the drug to be delivered and to obtain information from one or more position sensors. The information indicates the position of the displacement member within the drug cartridge. The control circuit is further configured to determine a first position of the displacement member within the drug cartridge based on information from one or more position sensors. The first position identifies the position of the displacement member before delivery of the dose of the drug. The control circuit is further configured to determine a second position of the displacement member within the drug device based on the intended dosage of the drug to be delivered, the second position indicating a desired position of the displacement member within the drug cartridge after delivery of the dosage of the drug. The control circuit is further configured to instruct the drive mechanism to advance the displacement member from the first position and, upon obtaining information from one or more position sensors indicating that the displacement member has reached the second position, to instruct the drive mechanism to stop the advancement of the displacement member.

[0007] In another embodiment, the present disclosure includes a housing configured to receive a drug cartridge that extends between its distal and proximal ends and has a septum at the distal end, and a displacement member that is inside the vial and is movable from the proximal end to the distal end to deliver the drug received by the vial from the distal end. The drug delivery device further includes a drive mechanism within the housing configured to advance the displacement member within the drug cartridge to deliver the drug when the drug cartridge is received within the housing, one or more position sensors positioned to detect the position of the displacement member within the drug cartridge, and a control circuit configured to control the operation of the drug delivery device. A method of delivering a drug using the drug delivery device, the method including a control circuit that determines the dosage of the intended drug to be delivered, one or more position sensors that detect the position of the displacement member within the drug cartridge and provide information indicating the position of the drug cartridge to the control circuit, the control circuit obtaining information from the one or more position sensors indicating the position of the displacement member within the drug cartridge, the control circuit determining a first position of the displacement member within the drug cartridge based on the information from the one or more position sensors, the first position identifying the position of the displacement member before delivery of the dosage of the drug, the control circuit determining a second position of the displacement member within the drug device based on the intended dosage of the drug to be delivered, the second position indicating the desired position of the displacement member within the drug cartridge after delivery of the dosage of the drug, the control circuit instructing the drive mechanism to advance the displacement member from the first position, and the control circuit obtaining information from the one or more position sensors indicating that the displacement member has reached the second position and instructing the drive mechanism to stop the advancement of the displacement member.

[0008] Various aspects and advantages of exemplary embodiments of the present disclosure are 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 the accompanying drawings. Refer to the accompanying drawings that form a part of this disclosure and illustrate embodiments that can implement the systems and methods described herein.

Brief Description of the Drawings

[0009]

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Modes for Carrying Out the Invention

[0010] Certain 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 that may be embodied in various forms. To avoid obscuring the present disclosure with unnecessary detail, well-known functions or structures are not described in detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as a representative basis for teaching one skilled in the art to variously use the present disclosure in substantially any appropriately detailed structure and as a basis for the claims. In this specification and the drawings, like reference numerals represent like, similar, or equivalent elements that can perform the same, similar, or equivalent functions.

[0011] The present disclosure generally relates to drug delivery devices and methods. More particularly, the present disclosure relates to devices and methods for automatically delivering an intended drug dosage to a user without presenting any dosage to the user on any user interface element of a drug delivery device.

[0012] The systems, devices, and methods described herein can deliver various drugs and can be applied to manage various diseases, including, for example, diabetes, anticoagulants such as heparin, palliative care analgesics, treatment of growth hormone deficiency such as somatotropin, and infertility treatment such as human chorionic gonadotropin or follicle-stimulating hormone.

[0013] In some embodiments, the systems, devices, and methods described herein can provide a user with multiple daily deliveries of a drug, for example, a mixture of rapid-acting and long-acting insulin via a drug delivery device. The systems, devices, and methods can facilitate the management of multiple daily deliveries of a drug without burdening the user (e.g., a diabetic patient or PWD) with a mental task to calculate an appropriate drug bolus dosage, evaluate the impact of treatment-related conditions (e.g., meal size, exercise program, or other lifestyle factors) on the drug bolus dosage, and determine the actual dosage delivered, etc.

[0014] <Drug Delivery and Management System> FIG. 1 shows a drug delivery and management system 100. 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 deliver various drugs and manage various diseases. The system 100 includes a specimen sensor system 102, one or more drug delivery devices (plural available) 110, a mobile application 104, and optionally, one or more secondary devices (plural available) 106. The drug delivery and management system 100 can further include one or more web services 105 that communicate with the mobile application 104 via a network 108 (e.g., cloud networking).

[0015] One or more drug delivery devices (plural available) 110 can participate in the system 100, exit the system, interact with the user to determine the intended dosage, and automatically deliver the intended dosage of the drug to the user without presenting the intended dosage on any user interface element of the drug delivery device (plural available) 110. In some cases, one or more drug delivery devices (plural available) 110 can be a syringe having a suitable shape, such as a pen shape. In some cases, one or more drug delivery devices (plural available) 110 can include an insulin delivery device, such as an insulin injection pen. In some cases, the insulin injection pen can be reusable by receiving, discharging, and receiving a new insulin cartridge.

[0016] The specimen sensor system 102 is configured to acquire various specimen measurement data and transmit the acquired specimen measurement data to the drug delivery device (plural available) 110. In some cases, the specimen sensor system 102 can include a glucose sensor system adapted to determine glucose values, such as, for example, a blood glucose meter (BGM), a flash glucose monitor, a continuous glucose monitor (CGM), etc. In some cases, the glucose sensor system 102 can function as a flash glucose monitor, a continuous glucose monitor, or both, by enabling intermittent and / or on-demand transmission of glucose data. In some cases, the glucose sensor system 102 can monitor changes in glucose values over a given period and provide glucose trend data. In some cases, the specimen sensor system 102 can wirelessly transmit data when queried by a reader device (e.g., using NFC communication). In some cases, the glucose sensor can wirelessly transmit data at predetermined intervals (e.g., using radio frequency) using any suitable communication standard (e.g., Bluetooth Low Energy (BLE)). In some cases, the specimen sensor system 102 can include multiple glucose sensor systems (e.g., one or more of a continuous glucose monitor, a flash glucose monitor, a glucose meter, etc.).

[0017] The specimen sensor system 102 can transmit specimen measurement data (e.g., glucose data) using multiple communication technologies. In some embodiments, one or more of the mobile application 104 and / or the drug delivery device(s) 110 can include an NFC reader adapted to obtain specimen measurement data from the specimen sensor system 102 when brought within the interrogation distance of the specimen sensor system 102. In some embodiments, one or more of the mobile application 104 and / or the drug delivery device(s) 110 can wirelessly receive sample measurement data from the sample sensor system 102 that is disseminated at a predetermined interval (e.g., every 30 seconds, every minute, every 2 minutes, every 3 minutes, every 5 minutes, every 10 minutes, every 15 minutes, etc.).

[0018] In the interrogation operation mode, the sample sensor system 102 can wirelessly transmit the sample measurement data to one or more of the mobile application 104 and / or the drug delivery device(s) 110. For example, when the drug delivery device(s) 110 interrogates the glucose sensor system 102, it can receive stored glucose data from the past 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, etc. Optionally, the disseminated glucose data can include the current or more recent glucose value and current glucose trend data. Optionally, one or more of the mobile application 104 and / or the drug delivery device(s) 110 can directly receive the latest glucose data (e.g., from the last 5, 10, 20, or 30 minutes) from the glucose sensor system 102 and issue an alarm, warning, or notification based on the latest glucose data.

[0019] The drug delivery device(s) 110 can be configured to supplement information regarding the delivery of the drug, including, for example, one or more user interface elements for presenting or displaying information and receiving user input, internal sensors for actual dose replenishment, and other communication interfaces for wireless or wired communication with one or more of the other drug delivery devices 110, the sample sensor system 102, the mobile application 104, and the optional secondary device(s) 106. Optionally, the drug delivery device(s) 110 may be associated with various specific types of insulin, such as rapid-acting insulin, long-acting insulin, a mixture of rapid-acting insulin and long-acting insulin, etc.

[0020] Rapid - acting insulin begins to function approximately 15 minutes after injection, reaches its peak approximately 1 hour or 2 hours after injection, and can last for about 2 - 4 hours. Long - acting insulin reaches the bloodstream several hours after injection and can tend to lower glucose levels for up to 24 hours. In some embodiments, a first drug delivery device 110 can be associated with long - acting insulin delivery, and a second drug delivery device 110 can be associated with rapid - acting insulin delivery. It should be understood that the drug delivery device(s) 110 may be configured to deliver any type of insulin other than rapid - acting insulin and long - acting insulin.

[0021] The drug delivery device(s) 110 can execute one or more algorithms to determine the intended dosage of the drug based on the sample measurement data from the sample sensor system 102. In some cases, the intended dosage can be further determined based on one or more treatment - related conditions from the user's input, one or more treatment parameters stored in the memory of the drug delivery device(s) 110, or a calculated insulin - on - board (IOB) value.

[0022] The drug delivery device(s) 110 can have one or more user interface elements to query the user to indicate that the user is ready for delivery without presenting the intended dosage on any of the user interface elements of the drug delivery device(s) 110. After receiving the user's instruction, the drug delivery device(s) 110 can automatically deliver the intended dosage.

[0023] In various embodiments described herein, the determined intended dosage is not normally displayed to the user in the normal operating mode of the drug delivery device(s) 110 via one or more user interface elements. In some cases, the drug delivery device(s) can operate in a service / maintenance mode in which the intended dosage or other dosage-related information can be presented or displayed to a technician, for example, via one of the user interface elements of the drug delivery device(s) 110, for device service / maintenance.

[0024] The service / maintenance mode can be triggered, for example, after input of a complex function on the drug delivery device(s) 110 or by a mobile application via a secondary device. In some cases, the intended dosage or other dosage-related information may be presented or displayed via one or more of the user interface elements of the drug delivery device(s) 110 in a particular service / maintenance mode with certain restrictions, such as a small font size that may not be readily apparent to the user.

[0025] In some embodiments, when a user attempts to access and / or adjust the intended dosage determined by the drug delivery device(s) 110 and not presented on any of the user interface elements of the drug delivery device(s) 110, the user can use one or more optional secondary device(s) 106 to access and / or adjust the intended dosage.

[0026] The secondary device(s) 106 can include, for example, smartphones, laptops, tablets, portable computers, and the like. Each of the secondary device(s) 106 can include a user interface for interacting with the user. The secondary device(s) 106 can present a query to the user indicating whether the user needs to access and / or manually adjust the intended dosage determined by the drug delivery device(s) 110. The secondary device(s) 106 can receive a user input dosage representing an adjustment of the dosage or intended dosage. The secondary device(s) 106 can wirelessly communicate with the drug delivery device(s) 110 to transmit the received user input dosage to the drug delivery device(s) 110. After receiving the user input dosage from the secondary device(s) 106, the drug delivery device(s) 110 can present (e.g., display) an indication that the drug delivery device(s) 110 has received the user input dosage from the secondary device(s) 106 via at least one of its user interface elements.

[0027] The drug delivery device(s) 110 can query the user to indicate that the user is ready to deliver the user input dosage and automatically deliver the user input dosage after receiving the user's instruction. In some embodiments, the drug delivery device(s) 110 can execute one or more algorithms to determine the actual dosage of the drug after delivering the intended dosage. The drug delivery device(s) 110 can compare the actual dosage with the intended dosage. If the actual dosage is not the same as the intended dosage, the drug delivery device(s) 110 can calculate an insulin on board (IOB) value based on the actual dosage and calculate a subsequent intended dosage for the next predetermined time based on the calculated IOB value. The IOB value refers to the amount of active insulin remaining in the user. Based on the history of the actual dosage delivered to the user and current data, the drug delivery device(s) 110 can execute one or more algorithms to calculate or predict the user's current IOB value.

[0028] In some embodiments, the drug delivery device(s) 110 can 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(s) 110 to prompt the user to input treatment-related conditions. The treatment-related conditions can include any external factors that can biologically affect the user's pharmaceutical requirements, including, for example, at least one of meal amount, exercise plan, sleep plan, and other lifestyle factors. For example, when the user is about to administer for a meal, a query may be presented to the user via the user interface of the drug delivery device(s) 110 to prompt the user to input an indication of the meal amount or category (e.g., small meal, medium meal, or large meal).

[0029] The indication of the meal amount or category (e.g., meal icon or indicator) can be based on the size of the icon, the number of carbohydrates displayed, the label (e.g., small or S, medium or M, large or L), or other characteristics of the meal such as, for example, the preferred meal selection made by the user, the meal having selected nutritional characteristics (e.g., carbohydrates), or a specific meal based on time (e.g., breakfast, lunch, dinner, snack).

[0030] It should be understood that in some embodiments, the drug delivery device(s) 110 may not present dosage recommendations for different meal amounts that have a low, moderate, or high impact on blood glucose to any of its user interface elements. Instead, the drug delivery device(s) 110 receives the user's input of one or more treatment-related conditions (e.g., meal amount) and determines the intended dosage of the drug based on the received treatment-related conditions without presenting the dosage to any of the user interface elements of the drug delivery device.

[0031] In some embodiments, the query to the user regarding treatment-related conditions can be generated or determined based on the user's personalized pattern data. The user's personalized pattern data can include, for example, the user's meal times in a day, the user's drug delivery times in a day, the user's exercise times in a day, the user's sleep times in a day, specimen measurement data (e.g., glucose levels) in response to the user's input for different treatment-related conditions, the user's lifestyle factor data or historical data regarding actual dosage data, etc. The lifestyle factor data or historical data can be collected by the specimen sensor system 102, the drug delivery device(s) 110, the mobile application 104, and / or other components of the system 100.

[0032] The drug delivery device(s) 110 can include a memory for storing the user's personalized pattern data. The drug delivery device(s) 110 can determine the content and timing (e.g., time) of the query in order to present the query to the user on the user interface element based on the user's personalized pattern data.

[0033] In some embodiments, the drug delivery device(s) 110 can include a memory for storing user-specific treatment or dosage parameters, such as, for example, a predetermined daily dosage or total daily basal dosage (TDBD) of long-acting insulin, insulin sensitivity factor (ISF), carbohydrate-to-insulin ratio (CR), correction amount based on glucose level range, total daily insulin dosage (TDD), target glucose value, recommended rapid-acting dosage for different meal amounts or categories, etc.

[0034] In some embodiments, the user-specific treatment or dosage parameters can be time- or day-dependent. For example, the CR and ISF values can be time-dependent.

[0035] In some embodiments, the drug delivery device(s) 110 can include a memory that stores a predetermined dosage of rapid-acting insulin for different meals or different meal amounts or categories.

[0036] In some embodiments, user-specific dosage parameters and / or different predetermined dosages for different meals can be updated via a mobile application 104 that is in wireless communication with one or more of the drug delivery device(s) 110. For example, an algorithm within the secondary device(s) 106 or network 108 can update user-specific treatment or dosage parameters.

[0037] In some embodiments, user-specific treatment or dosage parameters may be updated manually by a healthcare professional or by the user or caregiver.

[0038] In some embodiments, the drug delivery device(s) 110 can include an algorithm within the memory that is executed by a processor to automatically update user-specific treatment or dosage parameters.

[0039] In some embodiments, the drug delivery device(s) 110 can display or otherwise notify the user of the current glucose level and / or glucose trend data (e.g., the rate of change of the glucose level) based on glucose data received from the analyte sensor system 102. The drug delivery device(s) 110 can automatically determine the intended dosage of a drug (e.g., insulin) based on one or more of glucose data, user-specific treatment or dosage parameters, user input of treatment-related conditions, recommended dosages set by the user or a healthcare professional, time, meal data or classification, or any other suitable input.

[0040] The mobile application 104 can be stored and executed on any suitable mobile computing device, such as one or more of the secondary devices 106 which can be, for example, a smartphone, laptop, tablet, portable computer, etc. The mobile application 104 can be adapted to input and output (e.g., display) treatment-related information received wirelessly from other components of the system 100. The mobile application 104 can enable a graphical user interface (GUI) that allows a user to interact with the mobile application 104.

[0041] In some embodiments, the secondary device(s) 106 can store and execute a trusted mobile application within a trusted execution environment (hardware and / or software). Various functions and calculations related to the drug delivery and treatment management system 100, including notifications, warnings, queries, and recommendations presented to the user, can be executed, at least in part, by the trusted mobile application. Furthermore, some or all of the communication with the drug delivery device(s) 110 may be restricted to the trusted mobile application or the trusted mobile computing device. In some cases, the mobile application 104 can enable an authorized user to adjust the intended dosage to be delivered by one or more drug delivery device(s) 110 via a trusted mobile computing device such as the secondary device(s) 106 of FIG. 1.

[0042] Generally, embodiments of the present disclosure can use any suitable wireless communication protocol for communication between the drug delivery device(s), specimen sensor system, secondary device(s), other electronic devices, and / or other mobile devices of the system 100. Examples of suitable wireless communication protocols include Near Field Communication (ISO / IEC 14443 and 18092 compliant technologies), wireless modems and routers (IEEE 802.11 compliant technologies), and Bluetooth® / Bluetooth Low Energy (BLE) (IEEE 802.15 compliant technologies). In some cases, one or more drug delivery devices 110 may include one or more accessories such as, for example, a cap and / or a carrying case for the drug delivery device(s) 110. The one or more drug delivery device(s) 110 and the accessories may be integrated (e.g., attached or functionally connected) and may be implemented within an electronic package (e.g., a smart electronic device). In some cases, one or more drug delivery devices 110 may be combined with the system 100 via a profile created by the mobile application 104. In one embodiment, the mobile application 104 may query the web service 105 as to whether a profile for a particular user's device already exists and, if it does, request that it be transmitted.

[0043] The user profile may include the user's personalized pattern data, such as, for example, decision algorithms for determining the user's intended dosage, the user's historical data or physiological attributes (e.g., insulin sensitivity), actual glucose measurements, and historical or current data related to glucose response analysis. Once the user profile is created, the mobile application 104 may save insulin therapy-related settings along with the profile. The insulin therapy-related settings may include user-specific dosage parameters for the user, the delivery characteristics of the device, and specific techniques that may be used to determine the intended dosage.

[0044] In one embodiment, each delivery device profile may include a user profile that includes pre-configured dosage corrections for specific analyte measurement data (e.g., a specific glucose range) or specific treatment-related conditions (e.g., different meal amounts), or may be part of the user profile. In one embodiment, the pre-configured dosage can be entered in the mobile application 104. In another embodiment, the pre-configured dosage may be entered in one of the web services 105 (e.g., by a healthcare provider or a parent) and downloaded to the mobile application 104.

[0045] In some embodiments, a user profile that includes the user's personalized pattern data can be generated by the system 100 and updated over time. The system 100 enables the user or a healthcare professional to generate a user profile, for example, by setting the user's treatment parameters (e.g., the daily dosage of long-acting insulin, the dosage for different meal amounts or categories, the insulin effect value, the carbohydrate-to-insulin ratio, etc.) via the mobile application 104 or the web service 105, such as by creating a table of dosage corrections to be used for a specific range of glucose values.

[0046] The user profile can be stored in the memory of the drug delivery device(s) 110 and updated over time. For example, in some embodiments, one or more of the glucose data received from the analyte sensor system 102, the actual dosage data determined by the drug delivery device(s) 110, or the calculated IOB value can be analyzed to adjust the user's dosage parameters and / or meal-based dosage corrections.

[0047] <Drug Delivery Device> FIG. 2 is a block diagram of a drug delivery device 200 suitable for use as the drug delivery device(s) 110 within the system 100 of FIG. 1, according to some embodiments. The drug delivery device 200 includes a control circuit 210, a communication interface 202, a memory 204, sensing and actuation components 208, and one or more user interface elements 206.

[0048] The sensing and actuation components 208 include a drive mechanism 220, one or more position sensors 230, and one or more skin sensors 240.

[0049] The drive mechanism 220 is configured to advance a displacement member (e.g., a plunger) of a drug cartridge received within a housing to deliver a drug from the drug cartridge.

[0050] One or more position sensors 230 are positioned to detect the position of a displacement member (e.g., a plunger) within the drug cartridge. In some cases, the drive mechanism 220 can include an advancement mechanism (e.g., a piston) that engages a displacement member (e.g., a plunger) of the drug cartridge. The position sensor 230 is positioned to detect the position of an advancement mechanism or displacement member within the drug cartridge when the drug cartridge is received by the drug delivery device 200.

[0051] Examples for detecting the position of the displacement member are described in U.S. Patent No. 9,255,830, U.S. Patent No. 10,255,991, and U.S. Patent No. 10,183,120, as well as International Publication No. 2019 / 123257, International Publication No. 2019 / 123258, International Publication No. 2017 / 009724, International Publication No. 2019 / 186261, International Publication No. 2020 / 255085, and International Publication No. 2019 / 123441, all of which are hereby incorporated by reference in their entirety.

[0052] 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 and determines whether the drug delivery device 200 is in the correct position, location, or orientation for drug delivery. In some cases, various device components may be received or supported by the housing and integrated as a smart electronic device.

[0053] The communication interface 202 is coupled to the control circuit 210 and includes any suitable hardware, circuitry, logic, firmware, and other related components of the drug delivery device 200 configured to support communication between the drug delivery device 200 and one or more external electronic devices, mobile computing devices, and cloud networking such as the network 108 shown in the system 100 of FIG. 1. In some cases, the communication interface 202 can use one or more wireless communication technologies such as, for example, Near Field Communication (NFC), Bluetooth low energy (BLE), WiFi, etc. In some embodiments, the communication interface 202 can also support wired communication.

[0054] One or more user interface elements 206 include any suitable hardware, circuitry, logic, firmware, and other related components of the drug delivery device 200 configured to support user communication and interaction between the drug delivery device 200 and the user. One or more user interface elements 206 associated with the drug delivery device 200 can include one or more output elements such as, for example, a visual output device such as a display, an audio output device such as a speaker, a vibration device, etc.

[0055] One or more user interface elements 206 can further include one or more input elements such as, for example, buttons, knobs, touch screens or panels. In some cases, one or more user interface elements 206 can include a delivery button operable by a user to trigger a drive mechanism 220 to deliver a desired dosage of a medicament via a medicament cartridge 20. In some cases, one or more user interface elements 206 can include an ejection button operable by a user to trigger an ejection mechanism to eject the medicament cartridge 20 from the housing.

[0056] A suitable delivery button or ejection button can be a tactile push-button functionally coupled to a control circuit 210 to transmit a corresponding actuation signal to the control circuit 210 in response to different user actions.

[0057] The control circuit 210 is coupled to a communication interface 202, a memory 204, sensing and actuation components 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 medicament delivery device described herein. For example, the control circuit 210 supports the operation of the sensing and actuation components 208 in response to a user command from one or more user interface elements 206 to deliver a predetermined dosage of a medicament to the user via a medicament cartridge 20 to which a needle is attached.

[0058] Depending on the embodiment, the control circuit 210 can be implemented or realized in 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, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. In this regard, the steps of the methods or algorithms described in connection with the embodiments disclosed herein may be embodied directly in hardware, firmware, a software module executed by the control circuit 210, or any practical combination thereof.

[0059] In various embodiments, the control circuit 210 may further include, or be capable of, access to a memory 204 that can include any suitable non-transitory computer-readable medium for 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.

[0060] For the drug delivery device(s) 110 of FIG. 1 and the drug delivery device 200 of FIG. 2, various embodiments of the drug delivery device are provided. FIG. 3 is a perspective view of a drug delivery device 300 according to one embodiment.

[0061] The drug delivery device 300 includes a housing 10 that extends longitudinally between its first end 11 and its second end 13.

[0062] The housing 10 defines an internal space for receiving a drug cartridge 20 through an opening 15 at the first end 11 of the housing 10.

[0063] As shown in FIG. 3, the drug cartridge 20 is inserted into the housing 10 through the opening 15 at the first end 11 of the housing 10 along the longitudinal direction as indicated by the arrow. In some cases, the entire body of the drug cartridge 20 can be positioned inside the housing 10, and the distal end 21 of the drug cartridge 20 is accessible from the opening 15 for the user to install a needle thereon. In some cases, the main body portion of the drug cartridge 20 can be positioned inside the housing 10, and the distal end 21 projects outside the housing 10 through the opening 15.

[0064] In the embodiment shown in FIG. 3, the housing 10 can have an integral structure that can be formed from a plurality of parts assembled together.

[0065] In some embodiments, the housing 10 may have a first portion at a first end 11 and a second portion at a second end 13, and the first portion and the second portion can be engaged with each other by an engagement mechanism (e.g., a screwing mechanism). The drug cartridge is loaded into the first and / or second portions and can be discharged via a discharge mechanism such as a spring-loaded bayonet mechanism.

[0066] The drug delivery device 300 further includes a display panel 12 disposed on the outer surface of the housing 10.

[0067] The display panel 12 can include a display for presenting various information to the user, such as, for example, analyte measurement data (e.g., continuous glucose monitor (CGM) data, flash glucose monitor data, glucose meter data, etc.), queries to the user to prompt input of treatment-related conditions, indicators or icons representing treatment-related conditions (e.g., meal amount, exercise plan, etc.), warnings for glucose measurement values outside a predetermined range, queries indicating whether the user needs to manually adjust the intended dose, an indication that the drug delivery device has received a user input dose from a secondary device, instructions to the user to prime the drug delivery device before automatically delivering the intended dose, and the like.

[0068] The display panel 12 can be part of a user interface (UI) of the drug delivery device 300 for the user to interact and communicate with the drug delivery device 300. The display panel 12 may further include a touch screen, one or more touch buttons, one or more smart sensors for detecting a user's action (e.g., a finger touch), or other input mechanisms for receiving a user's input. One or more touch buttons on the touch screen can include, for example, an injection button, a discharge button. It should be understood that one or more of the touch buttons on the touch screen may be tactile buttons disposed on the outer surface of the housing 10. For example, in the embodiment shown in FIG. 5A, the drug delivery device 300 includes an injection button 14 and a discharge button 18 disposed on the outer surface of the housing 10.

[0069] FIG. 4A is a side perspective view of the drug delivery device 300. FIG. 4B is a first end view of the drug delivery device 300. FIG. 4C is a second end view of the drug delivery device 300.

[0070] As shown in FIG. 4A, the entire body of the drug cartridge 20 is positioned inside the housing 10, and the distal end 21 is recessed from the edge surface 111 of the first end 11 of the housing 10. The distal end 21 is accessible from the opening 15 for the user to install a needle thereon. It should be understood that the housing 10 can be configured to receive cartridges of different lengths.

[0071] As shown in FIG. 4B, the drug delivery device 300 includes one or more skin sensors 16 disposed on the edge surface 111 of the first end 11 of the housing 10.

[0072] 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 can include one or more capacitance sensors disposed on the edge surface 111 and configured to measure information resulting from the proximity interaction between the edge surface 111 and the user's skin. Although a pair of skin sensors are shown in FIG. 4B, it should be understood that one or more skin sensors 16 can be arranged at the first end 11 of the housing to detect the proximity of the skin. In some cases, the detection data from multiple skin sensors can be used to detect the orientation of the housing 10 with respect to the user's skin. For example, if the housing 10 is tilted at an angle such that the needle is not straight into the skin, the skin sensor 16 can detect 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 in an acceptable orientation, the skin sensor 16 can transmit a signal indicating that the drug delivery device 300 is in an acceptable position for drug delivery. In some embodiments, the drug delivery device 300 can further include one or more accelerometers for determining the insertion angle of the needle with respect to the user's skin surface.

[0073] As shown in FIG. 4C, the drug delivery device 300 includes an ejection button 18 at the second end 13, allowing the user to press it to disengage and eject the drug cartridge 20 from the drug delivery device 300.

[0074] The charging port 172 is also provided to allow the user to charge a battery (e.g., battery 174 as shown in FIG. 5A) included inside the housing 10. The charging port 172 can have battery charging specifications according to various industry standards (e.g., Universal Serial Bus (USB) industry standards).

[0075] FIG. 5A is a cross-sectional view of the drug delivery device 300. FIG. 5B is a cross-sectional view of a portion of the drug delivery device 300 of FIG. 5A.

[0076] The housing 10 of the drug delivery device 300 defines an internal space 19 for receiving the drug cartridge 20. The medicament cartridge 20 extends longitudinally between a distal end 21 and a proximal end 23. The medicament cartridge 20 includes a vial 20a having a partition wall at the distal end 21. The medicament cartridge 20 contains a plurality of doses of medicament and includes a displacement member 22 disposed at least partially inside the vial 20a of the medicament cartridge 20 between the proximal end 23 and the distal end 21.

[0077] The displacement member 22 is movable along the longitudinal direction of the medicament cartridge 20 from the proximal end 23 to the distal end 21 and delivers the medicament from the distal end 21 of the medicament cartridge 20. The displacement member 22.

[0078] In the embodiment shown in FIG. 5A, the displacement member 22 is a plunger. The vial 20a of the medicament cartridge 20 can have a transparent or translucent wall so that a user can observe the medicament inside the vial 20a. Dimension / dosage marks can be provided on the vial wall. Exemplary insulin cartridges are commercially available from Novo Nordisk A / S (Bagsvaerd, Denmark) under the trade name NovoLog and from Eli Lilly and Company (Indianapolis, Indiana) under the trade name HUMALOG.

[0079] The medicament delivery device 300 further includes a drive mechanism 32 disposed at an end of the internal space 19 opposite the opening 15.

[0080] The drive mechanism 32 is mechanically connected to a forward member 34 and is configured to move the forward member 34 longitudinally towards the opening 15.

[0081] In the embodiment shown in FIG. 5A, the forward 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 that engages a displacement member 22 (e.g., a plunger) of the drug cartridge 20 to advance the plunger 22 forward within the drug cartridge 20 when the drug cartridge 20 is received within the housing 10 of the drug delivery device 300. It should be understood that the advancing member 34 of the drug delivery device 300 may have any suitable configuration other than a piston.

[0082] The drug delivery device 300 further includes one or more position sensors 42 positioned to detect the position of the advancing member 34 or the displacement member 22 within the drug cartridge 20. For example, when the displacement member 22 (e.g., a plunger) advances longitudinally along by the advancing member 34 (e.g., a piston) at any point between the proximal end 23 and the distal end 21, the position sensor 42 can emit an optical signal towards the drug cartridge 20 and collect the reflected or transmitted optical signal from the drug cartridge 20.

[0083] The position sensor 42 is mounted inside the housing 10 facing the drug cartridge 20.

[0084] In some embodiments, an array of position sensors 42 is arranged along the longitudinal direction of the housing 10 between the proximal end 23 and the distal end 21 of the drug cartridge 20 to detect the position of the advancing member 34 or the displacement member 22 within the drug cartridge 20.

[0085] The drug delivery device 300 further includes a printed circuit board assembly (PCBA) 17 that can include various control circuits or electronic components such as, for example, a logic circuit, a drive controller circuit, a wireless communication circuit, a memory, and the like.

[0086] The printed circuit board assembly (PCBA) 17 is supported by the housing 10, powered by the 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.

[0087] The control circuit is configured to execute one or more algorithms stored in the memory to determine the intended dosage of the drug to be delivered. The control circuit is further configured to obtain information indicating the position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 from one or more position sensors 42. Based on the information from the one or more position sensors 42, the control circuit can execute one or more algorithms to determine a first position of the displacement member 22 within the drug cartridge 20. The first position identifies the position of the displacement member 22 before the delivery of the drug dosage.

[0088] In some embodiments, one or more position sensors 42 can detect a signal when a new drug cartridge is received by the housing 10. After receiving a signal from the position sensor 42, the control circuit can generate instructions for priming the drug delivery device and present them to the user. After the device is primed, 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 drug cartridge 20 for the control circuit to determine whether the device is properly primed. After determining that the device is properly primed, the control circuit can determine the first position of the displacement member 22 before the delivery of the drug dosage.

[0089] Based on the determined first position, the control circuit can determine a second position of the advancement member 34 or the displacement member 22 within the drug device based on the intended dosage of the drug to be delivered. The second position indicates the desired position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 after the delivery of the drug dosage.

[0090] At the determined first and second positions, the control circuit commands the drive mechanism 32 to advance the displacement member 22 from the determined first position, and when obtaining information indicating that the advance member 34 or the displacement member 22 has reached the second position from one or more position sensors 42, the drive mechanism 32 can be commanded to stop the advance of the displacement member 22.

[0091] After the delivery of the drug dosage, the control circuit is further configured to determine a third position of the advance member 34 or the displacement member 22 within the drug cartridge 20 based on information from one or more position sensors 42 after the displacement member 22 has stopped advancing.

[0092] The control circuit is further configured to determine the actual dosage of the drug delivered based on the first and third positions of the advance member 34 or the displacement member 22 within the drug cartridge 20. The actual dosage refers to the amount of drug delivered from the drug cartridge 20 after the displacement member 22 has stopped advancing. The control circuit can compare the actual dosage with the intended dosage. If the actual dosage is not the same as the intended dosage, the control circuit can execute one or more algorithms to calculate an insulin on - board (IOB) value based on the actual dosage and calculate a subsequent intended dosage for the next predetermined time based on the calculated IOB value.

[0093] Automatically deliver drugs to the user FIG. 6 is a flowchart of a method 600 for delivering a drug using a drug delivery device according to an embodiment.

[0094] The drug delivery device includes one or more user interface elements, a control circuit, and a memory. Method 600 can be implemented, for example, by any drug delivery and management system and / or any drug delivery device described herein, such as the drug delivery and management system 100 of the embodiment shown in FIG. 1 and the drug delivery devices 200, 300 of the embodiments shown in FIGS. 2-5B.

[0095] At 610, the drug delivery device receives the user's analyte measurement data. The drug delivery device can include a wireless communication component to receive analyte measurement data from an analyte sensor system, such as the analyte sensor system 102 shown in FIG. 1. For example, in some embodiments, the drug delivery device can receive glucose data (e.g., current glucose level) or glucose trend data (e.g., rate of change of glucose level) from a glucose sensor system.

[0096] Then, method 600 proceeds to 620. 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, if the drug delivery device determines that the received glucose data or trend data exceeds a predetermined criterion, the drug delivery device can generate an alert or warning for presentation to the user on the user interface element. In some embodiments, if the drug delivery device determines that the received glucose data or trend data is within a predetermined criterion, the drug delivery device can present the received glucose data and / or trend data to the user on the user interface element without triggering an alert or warning.

[0097] Then, method 600 proceeds to 630. FIG. 8 shows an exemplary user interface 810 for a drug delivery device, including a graphic display of glucose data 811 and / or glucose trend data 812 on the display or touch screen 802. The trend data 812 includes a series of glucose data along an axis indicating time. The user interface 810 further includes virtual touch buttons 813 on the touch screen 802 to receive user input 816 (e.g., press and hold with the user's finger) for displaying data. The touch screen 802 can be configured to receive user input 817 (e.g., swipe with the user's finger) to change the graphic display of the glucose data 811 and / or the glucose trend data 812. The user interface 810 further includes a graphic display of a notification 814 regarding the displayed glucose data 811 and / or trend data 813.

[0098] At 630, the drug delivery device determines the intended dose of the drug based on the received analyte measurement data. In some embodiments, the intended dose can be further determined or adjusted based on one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, or a calculated insulin on-board (IOB) value.

[0099] The method 600 then proceeds to 640. The one or more treatment-related conditions can include, for example, at least one of a meal amount, a sleep schedule, an exercise plan, etc. The one or more treatment parameters can include, for example, the daily dose of basal insulin, the dose for different meal amounts or categories, an insulin effectiveness value, a carbohydrate-to-insulin ratio, etc.

[0100] In some embodiments, the drug delivery device can present a query to the user to prompt the user to input one or more treatment-related conditions via one or more user interface elements. In some embodiments, the content of the query and the timing of presenting the query to the user can be determined based on the user's personalized pattern data.

[0101] The personalized pattern data can include, 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, specimen measurement data (e.g., glucose levels) in response to the user's input for different treatment-related conditions, actual dosage data, etc., that is, the user's lifestyle factor data or historical data. The lifestyle factor data or historical data can be stored in the memory of the drug delivery device. The drug delivery device can 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 to determine the content and timing (e.g., time) of the query, and to present the query to the user 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 any computing device / component of a drug delivery and management system such as 100 of the embodiment shown in FIG. 1 to execute one or more algorithms to analyze the personalized pattern data and determine the query. Exemplary patient pattern data is described in U.S. Patent No. 10,426,896, U.S. Patent No. 11,083,852, U.S. Patent No. 10,456,090, and International Publication No. 2021 / 072437, which are hereby incorporated by reference.

[0102] One or more treatment parameters can include, for example, the daily dosage of long-acting insulin, the dosage for different meal amounts or categories, the insulin effect value, the carbohydrate-to-insulin ratio, etc.

[0103] In some embodiments, the treatment parameters of a particular user may be stored in the memory of the drug delivery device. The drug delivery device can receive an update of one or more treatment parameters from a mobile application, such as the mobile application 104 of the embodiment shown in FIG. 1, via its wireless communication component. In some embodiments, in order to update the treatment parameters, one or more algorithms can be executed by the mobile application via a secondary device, such as the secondary device(s) 106 of the embodiment shown in FIG. 1, or via a network, such as the network 108 of FIG. 1.

[0104] The mobile application can automatically deliver the updated treatment parameters to the drug delivery device. In some embodiments, the treatment parameters may be updated manually by a healthcare professional or by the user or caregiver. In some embodiments, the drug delivery device can include an algorithm in the memory executed by a processor to automatically update the treatment parameters.

[0105] In some embodiments, the drug delivery device can receive user input via one or more user interface elements to confirm an update of one or more treatment parameters. In some embodiments, a query may be presented via the user interface of a secondary device (e.g., the secondary device(s) 106 of FIG. 1) to indicate whether the user needs to update one or more treatment-related conditions, one or more treatment parameters, and / or manually adjust the intended dosage determined by the drug delivery device.

[0106] At 640, the drug delivery device queries the user to indicate that the user is ready for delivery without presenting the intended dosage on any of the one or more user interface elements of the drug delivery device.

[0107] Next, method 600 proceeds to 650. In some embodiments, the drug delivery device can 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 located on the user's skin for drug delivery. The control circuit of the drug delivery device receives skin detection data from the skin sensors and executes 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, generating a corresponding query and presenting it on one or more of the user interface elements to indicate whether the user is ready for delivery or if any adjustment is needed. In some embodiments, the user can access and / or adjust the intended dosage using a secondary device, such as secondary device(s) 106 of FIG. 1, before querying the user at 640. After receiving the user input dosage from the secondary device, the drug delivery device presents (e.g., displays) an indication that the drug delivery device has received the user input dosage from the secondary device via at least one of its user interface elements and can query the user to indicate that the user is ready to deliver the user input dosage.

[0108] At 650, after receiving the user's instruction, the drug delivery device automatically delivers a defined dosage of the drug based on the intended dosage determined at 630. When the user receives an indication that the drug delivery device is ready for drug delivery from a user interface element of the drug delivery device, the user can engage a user interface element, such as a delivery button, to trigger the device to deliver a defined dosage of the drug. The drug delivery device attempts to deliver the dosage based on the intended dosage automatically determined by the drug delivery device at 630, but it should be understood that the actual dosage delivered to the user may differ from the intended dosage for various reasons.

[0109] Embodiments of drug delivery devices and methods provide for controlling a device to deliver a dosage based on an intended dosage, determining an actual dosage of the drug after delivery, calculating an insulin on board (IOB) value based on the actual dosage, and determining a subsequent intended dosage over a next predetermined time period based on the calculated IOB value.

[0110] FIG. 7 is a flowchart of a method 700 of delivering a drug using a drug delivery device including a housing configured to receive a drug cartridge, according to another embodiment. A suitable drug cartridge includes a vial extending between its distal end and proximal end and having a septum at the distal end, and a displacement member inside the vial and movable from the proximal end to the distal end to deliver the drug received by the vial from the distal end. A suitable drug delivery device as used herein includes a drive mechanism within a housing and, when a drug cartridge is received within the housing, advances the displacement member within the drug cartridge to deliver the drug.

[0111] The drug delivery device further includes one or more position sensors positioned to detect the position of the displacement member within the drug cartridge, and a control circuit configured to control the operation of the drug delivery device.

[0112] It should be understood that method 600 can be implemented, for example, by any drug delivery and management system and / or any drug delivery device described herein, such as the drug delivery and management system 100 of FIG. 1 and the drug delivery devices 200, 300 of FIGS. 2-5B.

[0113] At 710, the control circuit of the drug delivery device determines an intended dosage of the drug to be delivered. The intended dosage of the drug can be determined based on received analyte measurement data. In some embodiments, the intended dosage may be further determined or adjusted based on one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, or a calculated insulin on board (IOB) value. The control circuit of the drug delivery device can determine the intended dosage by any suitable method described herein, such as, for example, at 630 of method 600 of FIG. 6.

[0114] At 720, one or more position sensors of the drug delivery device detect the position of the displacement member within the drug cartridge and provide information indicating the position of the drug cartridge to the control circuit. For example, in the embodiment shown in FIG. 5A, one or more position sensors 42 of the drug delivery device 300 are positioned to detect the position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 and provide information indicating the position of the drug cartridge 20 to the control circuit 17.

[0115] At 730, the control circuit of the drug delivery device obtains information indicating the position of the displacement member within the drug cartridge from one or more position sensors. For example, in the embodiment shown in FIG. 5A, the control circuit 17 of the drug delivery device 300 can obtain information indicating the position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 from one or more position sensors 42.

[0116] At 740, the control circuit of the drug delivery device determines a first position of the displacement member within the drug cartridge based on the information from one or more position sensors obtained at 730. The first position identifies the position of the displacement member before delivery of the dosage of the drug. For example, in the embodiment shown in FIG. 5A, the control circuit 17 of the drug delivery device 300 can execute one or more algorithms stored in the memory to determine the first position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 based on the information from one or more position sensors 42 obtained at 730.

[0117] At 750, the control circuit of the drug delivery device determines the second position of the displacement member within the drug device based on the intended dosage of the drug to be delivered. The second position indicates the desired position of the displacement member within the drug cartridge after delivery of the dosage of the drug. For example, in the embodiment shown in FIG. 5A, the control circuit 17 of the drug delivery device 300 may execute one or more algorithms stored in a memory to determine the second position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 based on the intended dosage of the drug to be delivered.

[0118] At 760, the control circuit of the drug delivery device commands the drive mechanism to advance the displacement member from the first position. For example, in the embodiment shown in FIG. 5A, the control circuit 17 of the drug delivery device 300 may command the drive mechanism 32 to advance the advancement member 34 or the displacement member 22 from the first position.

[0119] At 765, the control circuit of the drug delivery device obtains information regarding the position of the displacement member from the position sensor. For example, in the embodiment shown in FIG. 5A, when the drive mechanism 32 advances the displacement member 22, the control circuit 17 of the drug delivery device 300 may obtain information regarding the position of the advancement member 34 or the displacement member 22 within the drug cartridge 20 from the position sensor 42 via the advancement member 34.

[0120] At 770, when the control circuit of the drug delivery device obtains information from one or more position sensors indicating that the displacement member has reached the second position, it commands the drive mechanism to stop the advancement of the displacement member. For example, in the embodiment shown in FIG. 5A, when the control circuit 17 of the drug delivery device 300 obtains information from one or more position sensors 42 indicating that the advancement member 34 or the displacement member 22 has reached the second position, it may command the drive mechanism 32 to stop the advancement of the displacement member 22.

[0121] At 775, after delivery of the dosage of the medicament, the control circuit determines a third position of the displacement member within the medicament cartridge after the displacement member has stopped advancing, based on information from one or more position sensors. For example, in the embodiment shown in FIG. 5A, the control circuit 17 executes one or more algorithms stored in the memory to determine a third position of the advancing member 34 or the displacement member 22 within the medicament cartridge 20 after the advancing member 34 or the displacement member 22 has stopped advancing based on information from one or more position sensors 42.

[0122] At 780, the control circuit determines the actual dosage of the medicament delivered based on the first and third positions of the displacement member within the medicament cartridge. For example, in the embodiment shown in FIG. 5A, the control circuit 17 executes one or more algorithms stored in the memory to determine the actual dosage of the medicament delivered based on the first and third positions of the advancing member 34 or the displacement member 22 within the medicament cartridge 20.

[0123] In some embodiments, the control circuit can compare the actual dosage to the intended dosage. If the actual dosage is not the same as the intended dosage, the control circuit can execute one or more algorithms to calculate an insulin on board (IOB) value based on the actual dosage and calculate a subsequent intended dosage for the next predetermined time based on the calculated IOB value.

[0124] <Aspect> It is understood that any one of the aspects can be combined with one or more other aspects (if any).

[0125] Aspect 1 is a method of delivering a medicament using a medicament delivery device, the medicament delivery device comprising one or more user interface elements, a control circuit, and a memory, receiving, via the medicament delivery device, the user's analyte measurement data, and Presenting information related to the analyte measurement data to the user via one or more user interface elements; Determining a dosage of the drug intended based on the analyte measurement data; Querying the user to indicate that the user is ready to deliver the drug without presenting the intended dosage to any of the one or more user interface elements of the drug delivery device; Automatically delivering the intended dosage after receiving an instruction from the user. The method includes the above steps.

[0126] Aspect 2 is the method of Aspect 1, wherein the intended dosage is further determined based on at least one of one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, and a calculated insulin on board (IOB) value.

[0127] Aspect 3 further includes receiving, via the user interface of the secondary device, a user input dosage representing an adjustment of the dosage or the intended dosage, and the secondary device wirelessly communicates with the drug delivery device to transmit the received user input dosage to the drug delivery device. This is the method of Aspect 1 or 2.

[0128] Aspect 4 further includes 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 the user input dosage from the secondary device. This is the method of Aspect 3.

[0129] Aspect 5 further includes querying the user to indicate that the user is ready to deliver the user input dosage, and automatically delivering the user input dosage after receiving an instruction from the user. This is the method of Aspect 4.

[0130] Aspect 6 is any one of the methods of Aspects 3 to 5, further including querying the user via the user interface of the secondary device to indicate whether the user needs to manually adjust the intended dosage.

[0131] Aspect 7 is any one of the methods of Aspects 1 to 6, further including presenting to the user a query that prompts the user to enter one or more treatment-related conditions via one or more user interface elements at a predetermined time.

[0132] Aspect 8 is the method of Aspect 7, further including determining the query based on the user's personalized pattern data.

[0133] Aspect 9 is any one of the methods of Aspects 2 to 8, further including updating one or more treatment parameters based on one or more previously stored treatment parameters and at least one of previous specimen measurement data, dosage data, and dietary data.

[0134] Aspect 10 is the method of Aspect 9, further including receiving an update of one or more treatment parameters from a mobile application via the wireless communication component of the drug delivery device.

[0135] Aspect 11 is the method of Aspect 9 or 10, further including receiving the user's input via one or more user interface elements to confirm the update of one or more treatment parameters.

[0136] Aspect 12 is any one of the methods of Aspects 1 to 11, further including determining the actual dosage of the drug after delivering the intended dosage.

[0137] Aspect 13 is the method of Aspect 12, further including comparing an actual dosage with an intended dosage, calculating an insulin on board (IOB) value based on the actual dosage when the actual dosage is not the same as the intended dosage, and calculating a subsequent intended dosage for a next predetermined time based on the calculated IOB value.

[0138] Aspect 14 is any one of the methods of Aspects 1 to 13, including prompting the user for an instruction to prime a drug delivery device before automatically delivering an intended dosage, by querying the user to indicate that the user is ready.

[0139] Aspect 15 includes a housing configured to receive a drug cartridge including a vial extending between its distal end and proximal end and having a septum at the distal end, and a displacement member inside the vial and movable from the proximal end to the distal end to deliver the drug received by the vial from the distal end, a drive mechanism within the housing configured to advance the displacement member within the drug cartridge to deliver the drug when the drug cartridge is received within the housing, one or more position sensors positioned to detect the position of the displacement member within the drug cartridge when the drug cartridge is received within the housing, determining the intended dosage of the drug to be delivered, obtaining information from one or more position sensors indicating the position of the displacement member within the drug cartridge, determining a first position of the displacement member within the drug cartridge based on the information from the one or more position sensors, the first position identifying the position of the displacement member before delivery of the dosage of the drug, determining a second position of the displacement member within the drug device based on the intended dosage of the drug to be delivered, the second position indicating the desired position of the displacement member within the drug cartridge after delivery of the dosage of the drug, instructing the drive mechanism to advance the displacement member from the first position When information from one or more position sensors indicating that the displacement member has reached the second position is acquired, the drive mechanism is configured to command the displacement member to stop advancing. A drug delivery device comprising a control circuit.

[0140] Aspect 16 is that after the delivery of the drug dosage, the control circuit Based on information from one or more position sensors, determine the third position of the displacement member in the drug cartridge after the displacement member has stopped advancing. The drug delivery device of aspect 15, which is configured to determine the actual dosage of the drug delivered based on the first and third positions of the displacement member in the drug cartridge.

[0141] Aspect 17 is the drug delivery device of aspect 15 or 16, further comprising a push button for triggering the drive mechanism.

[0142] Aspect 18 is the drug delivery device of aspect 15, further comprising a skin sensor positioned at the distal end of the housing for detecting the skin.

[0143] Aspect 19 is the drug delivery device of aspect 15, further comprising a wireless communication component configured to receive specimen measurement data from a specimen sensor system.

[0144] Aspect 20 The specimen measurement data includes at least one of continuous glucose monitor (CGM) data, flash glucose monitor data, or glucose meter data. The drug delivery device of aspect 19.

[0145] Aspect 21 is the drug delivery device of aspect 19, wherein the wireless communication component is configured to receive one or more treatment parameters from a mobile application.

[0146] Aspect 22 is the drug delivery device of Aspect 21, wherein one or more treatment parameters include at least one of the daily dose of sustained insulin, the dose for different meal amounts, the insulin effect value, or the carbohydrate-to-insulin ratio.

[0147] Aspect 23 is the drug delivery device of Aspect 15, further comprising one or more user interface elements for displaying the sample measurement data to the user.

[0148] Aspect 24 is the drug delivery device of Aspect 15, further comprising one or more user interface elements for presenting a query prompting the user to input one or more treatment-related conditions.

[0149] Aspect 25 is the drug delivery device of Aspect 24, wherein one or more treatment-related conditions include at least one of the meal amount or the exercise plan.

[0150] Aspect 26 is the drug delivery device of Aspect 15 which is a smart insulin injection pen.

[0151] Aspect 27 is a method of delivering a drug using a drug delivery device, the drug delivery device comprising a housing configured to receive a drug cartridge including a vial extending between its distal end and proximal end and having a partition at the distal end, and a displacement member inside the vial and movable from the proximal end to the distal end to deliver the drug received by the vial from the distal end, the drug delivery device further comprising a drive mechanism in the housing configured to advance the displacement member in the drug cartridge to deliver the drug when the drug cartridge is received in the housing, one or more position sensors positioned to detect the position of the displacement member in the drug cartridge, and a control circuit configured to control the operation of the drug delivery device, the method comprising: determining, by the control circuit, the intended dose of the drug to be delivered; One or more position sensors detect the position of a displacement member within a drug cartridge and provide information indicating the position of the drug cartridge to a control circuit, the control circuit obtains information from one or more position sensors indicating the position of a displacement member within the drug cartridge, the control circuit determines a first position of the displacement member within the drug cartridge based on information from one or more position sensors, wherein the first position identifies the position of the displacement member prior to delivery of a dosage of the drug, determining the first position, the control circuit determines a second position of the displacement member within the drug device based on the intended dosage of the drug to be delivered, wherein the second position indicates the desired position of the displacement member within the drug cartridge after delivery of the dosage of the drug, determining the second position, the control circuit instructs a drive mechanism to advance the displacement member from the first position, when the control circuit obtains information from one or more position sensors indicating that the displacement member has reached the second position, the control circuit instructs the drive mechanism to stop advancing the displacement member, a method comprising.

[0152] Aspect 28 is, after delivery of a dosage of the drug, the control circuit determines a third position of the displacement member within the drug cartridge based on information from one or more position sensors, after the displacement member has stopped advancing, the control circuit further determines the actual dosage of the drug delivered based on the first and third positions of the displacement member within the drug cartridge, the method of aspect 27.

[0153] Aspect 29 further includes comparing the actual dosage to the intended dosage, calculating an insulin on-board (IOB) value based on the actual dosage if the actual dosage is not the same as the intended dosage, and calculating a subsequent intended dosage for a next predetermined time based on the calculated IOB value, the method of aspect 28.

[0154] Aspect 30 is the method of aspect 27, further comprising receiving sample measurement data from a sample sensor system via a wireless communication component.

[0155] Aspect 31 is the method of aspect 30, wherein the sample measurement data includes at least one of continuous glucose monitor (CGM) data, flash glucose monitor data, or glucose meter data.

[0156] Aspect 32 is the method of aspect 27, further comprising receiving one or more treatment parameters from a mobile application via a wireless communication component.

[0157] Aspect 33 is the method of aspect 32, wherein the one or more treatment parameters includes at least one of the daily dose of long-acting insulin, the dose for different meal amounts, the insulin effect value, or the carbohydrate-to-insulin ratio.

[0158] Aspect 34 is the method of aspect 27, further comprising presenting to the user a query prompting the user to input one or more treatment-related conditions via a user interface.

[0159] Aspect 35 is the method of aspect 34, wherein the one or more treatment-related conditions includes at least one of the meal amount or the exercise plan.

[0160] Aspect 36 is the method of aspect 27, further comprising displaying the sample measurement data to the user via a user interface of a drug delivery device.

[0161] Aspect 37 is the method of aspect 36, further comprising displaying a warning for glucose measurement values outside a predetermined range via a user interface.

[0162] 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 with respect to the user's skin.

[0163] Aspect 39 is the method of Aspect 27, wherein the intended dosage of the drug is determined based on at least one of the sample measurement data, optionally one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, or the calculated insulin on board (IOB) value.

[0164] Aspect 40 is the method of Aspect 27, further comprising receiving, via a user interface, an input from the user indicating that the user is ready for delivery.

[0165] The terms used herein are intended to describe particular embodiments and are not intended to be limiting. The terms "a", "an", and "the" include the plural unless specifically stated otherwise. The terms "comprises" and / or "comprising", as used herein, specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or components. With respect to the foregoing description, it should be understood that various changes may be made in detail, particularly with regard to the materials used, as well as the shape, size, and arrangement of the parts, without departing from the scope of the present disclosure. The present specification and the described embodiments are merely illustrative, and the true scope and spirit of the present disclosure are indicated by the following claims.

Claims

1. A method for delivering a drug using a drug delivery device, wherein the drug delivery device comprises one or more user interface elements, a control circuit, and a memory. The drug delivery device receives the user's sample measurement data, To present information related to the sample measurement data to the user via the one or more user interface elements, Based on the aforementioned sample measurement data, the intended dosage of the drug is determined, Without displaying the intended dosage in any of the one or more user interface elements of the drug delivery device, the device prompts the user to indicate that they are ready to deliver the drug, A method comprising automatically delivering the intended dose after receiving instructions from the user.

2. The intended dose is determined based on at least one of one or more treatment-related conditions, one or more treatment parameters stored in the memory of the drug delivery device, and a calculated insulin onboard (IOB) value. The method according to claim 1.

3. The secondary device further includes receiving a user-input dosage representing a dosage or adjustment of the intended dosage via the user interface of the secondary device, and the secondary device wirelessly communicates with the drug delivery device to transmit the received user-input dosage to the drug delivery device. The method according to claim 1.

4. The drug delivery device further includes displaying an indication via at least one of the one or more user interface elements of the drug delivery device that the drug delivery device has received the user-inputted dosage from the secondary device, The method according to claim 3.

5. The further includes querying the user to indicate that the user is ready to deliver the user-inputted dosage, and automatically delivering the user-inputted dosage after receiving instructions from the user. The method according to claim 4.

6. The secondary device further includes querying the user via the user interface to indicate whether the user needs to manually adjust the intended dosage, The method according to claim 3.

7. The further includes presenting the user with a query prompting the user to input one or more treatment-related conditions via one or more user interface elements at a predetermined time, The method according to claim 1.

8. The query is further determined based on the user's personal pattern data, The method according to claim 7.

9. The further includes updating one or more previously stored therapeutic parameters, as well as at least one of previous specimen measurement data, dosage data, and dietary data, The method according to claim 2.

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

11. The system further includes receiving user input via one or more user interface elements to confirm updates to one or more treatment parameters. The method according to claim 9.

12. The process further includes determining the actual dose of the drug after delivering the intended dose. The method according to claim 1.

13. The further steps include comparing the actual dose with the intended dose, calculating an insulin onboard (IOB) value based on the actual dose if the actual dose is not the same as the intended dose, and calculating a subsequent intended dose for the next predetermined time based on the calculated IOB value. The method according to claim 12.

14. Prompting the user to indicate that the user is ready includes presenting the user with an instruction to prime the drug delivery device before automatically delivering the intended dose. The method according to claim 1.

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