Self-regulating dosage injection

Abstract

Systems, methods, and apparatuses generally relate to autonomous dosage injection. One or more examples relate to a durable insulin injection device. Such a durable dosage injection device can include a chamber, a drive mechanism, logic circuitry, and an actuator. The chamber may be for receiving a filled insulin cartridge. The drive mechanism can apply a force to a plunger of the received filled insulin cartridge, and the plunger is arranged to move within the received cartridge in response to the force applied by the drive mechanism, thereby pushing the fluid within the received cartridge toward an interface for dispensing the fluid. The logic circuitry may be for receiving user analyte data and calculating a target amount of insulin to be delivered to the user. The dosage ready confirmation actuator may be for the user to activate to cause insulin to be delivered to the user. In one or more examples, the durable insulin injection device does not provide the user with an indication of the calculated target amount of insulin for a non-zero calculated target amount of insulin.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of 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 a part of the disclosure of this application and are hereby incorporated by reference in their entirety.

[0002] One or more examples generally relate to injection dosages of therapeutic agents, including drugs and insulin, and devices and systems therefor.

Background Art

[0003] When a medical condition cannot be cured, treatments and therapies may be used to alleviate or control the medical condition. For example, one or more drugs can be administered to the body to alleviate or control the medical condition or its symptoms. As a non - limiting example, biologically active substances ( "drugs") can be injected, infused, or inhaled into the body to alleviate, prevent, or otherwise control a medical condition or its symptoms. Sometimes, multiple administrations of one or more drugs per day are required, so the patient, or the patient's healthcare provider or caregiver, must pre - plan the time, type, and amount of the drug to be administered. When a medical condition is self - managed, the patient may have to self - monitor their physiological state or biological characteristics via a biological sample (e.g., but not limited to, a blood or tissue sample) or other means and self - administer a drug. To self - administer, the patient may have to determine the amount of the drug to be administered, which can be based on various physiological or lifestyle factors. Thus, the patient faces a significant cognitive burden in self - managing the medical condition.

[0004] To easily identify the description of any particular element or act, the most significant digit of a reference number refers to the figure number in which that element is first introduced.

Brief Description of the Drawings

[0005]

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DETAILED DESCRIPTION OF THE INVENTION

[0006] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof and show, by way of illustration, specific examples of the examples in which the disclosure may be practiced. These examples are described in sufficient detail to enable those skilled in the art to practice the disclosure. However, other examples made possible by this specification may be utilized and changes may be made in structure, materials, and processes without departing from the scope of the disclosure.

[0007] The figures presented herein are not meant to be actual views of any particular method, system, device, or structure, but are merely idealized representations used to illustrate examples of the disclosure. In some cases, similar structures or components in the various figures may retain the same or similar numerals for the convenience of the reader. However, the similarity of the numerals does not necessarily mean that the sizes, compositions, configurations, or other characteristics of the structures or components are the same.

[0008] The following description may include examples to assist one of ordinary skill in the art in implementing the disclosed examples. The use of the terms "exemplary," "by example," and "for example" means that the relevant description is illustrative, and the scope of the present disclosure is intended to include examples and legal equivalents, but the use of such terms is not intended to limit either the scope of the examples or the present disclosure to the specified components, steps, features, functions, etc.

[0009] It will be readily understood that the components of the examples generally described herein and shown in the drawings can be arranged and designed in a wide variety of different configurations. Accordingly, the following description of the various examples is not intended to limit the scope of the present disclosure and is merely representative of the various examples. Although various aspects of the examples can be presented in the drawings, the drawings are not necessarily drawn to scale unless otherwise indicated.

[0010] Furthermore, the specific embodiments illustrated and described are merely examples and should not be construed as the only way to implement the present disclosure unless otherwise specified herein. To avoid obscuring the present disclosure with unnecessary detail, elements, circuits, and functions can be shown in block diagram form. Conversely, the specific embodiments illustrated and described are merely examples and should not be construed as the only way to implement the present disclosure unless otherwise specified herein. Furthermore, the block designations and the logical partitioning between various blocks are examples of specific embodiments. It will be readily apparent to one of ordinary skill in the art that the present disclosure can be implemented by many other partitioning solutions. For the most part, details regarding timing considerations and the like are not necessary for a complete understanding of the present disclosure and are omitted when within the capabilities of one of ordinary skill in the art.

[0011] One of ordinary skill in the art will understand that information and signals can be represented using any of a variety of different technologies and techniques. Some of the drawings may present signals as a single signal for clarity of presentation and explanation. A signal can represent a bus of signals, the bus can have various bit widths, and it will be understood by those skilled in the art that the present disclosure can be implemented for any number of data signals including a single data signal.

[0012] The various illustrative logical blocks, modules, and circuits described in connection with the examples disclosed herein can be implemented or executed using a general purpose processor, a dedicated processor, a digital signal processor (DSP), an integrated circuit (IC), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gates or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor (also referred to herein as a host processor or simply a host) may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration. A general purpose computer including a processor is regarded as a dedicated computer while the general purpose computer is configured to execute computing instructions (e.g., software code) related to the examples of the present disclosure.

[0013] The examples may be described with respect to processes illustrated or described as a flow process, a flowchart, a flow diagram, a structural diagram, or a block diagram. A flowchart can describe operational actions as a sequential process, but many of these actions can be performed in a different sequence, in parallel, or substantially simultaneously. Also, the order of the actions may be rearranged. The process can correspond to a method, a thread, a function, a procedure, a subroutine, a subprogram, other structures, or a combination thereof. Furthermore, the methods disclosed herein may be implemented in hardware, software, or both. When implemented in software, the functionality may be stored or transmitted as one or more instructions or codes on a computer-readable medium. The computer-readable medium includes both a computer storage medium and a communication medium that facilitates transfer of a computer program from one place to another.

[0014] Any reference in this specification to an element using terms such as "first", "second", etc. does not limit the quantity or order of those elements unless such a limitation is explicitly stated. Rather, these terms may be used herein as a convenient way to distinguish between two or more elements or examples of elements. Thus, references to first and second elements do not mean that only two elements can be used there, or that the first element must come before the second element in any way. Furthermore, unless otherwise specified, a set of elements can include one or more elements.

[0015] As used herein, the term "substantially" with respect to a given parameter, characteristic, or condition includes the degree to which one of ordinary skill in the art would understand that the given parameter, characteristic, or condition is met with a small degree of variance, such as within acceptable manufacturing tolerances. By way of example, depending on the particular parameter, characteristic, or condition being substantially met, the parameter, characteristic, or condition may be met at least 90%, at least 95%, or at least 99%.

[0016] In this description, the term "coupled" and its derivatives may be used to indicate that two elements cooperate or interact with each other. When an element is described as being "coupled" to another element, that element may be in direct physical or electrical contact, or there may be intervening elements or layers. In contrast, when an element is described as being "directly coupled" to another element, there are no intervening elements or layers. The term "connected" may be used interchangeably with the term "coupled" in this specification and has the same meaning unless specifically indicated otherwise or the context indicates otherwise to one of ordinary skill in the art.

[0017] Type 1 diabetes is a chronic metabolic disorder that occurs when a person's pancreas cannot produce sufficient amounts of the hormone insulin, resulting in the person's metabolism being unable to properly absorb sugars and starches. This can lead to hyperglycemia or hypoglycemia. Hyperglycemia is the presence of excessive amounts of glucose in the plasma. Persistent hyperglycemia is associated with a variety of severe symptoms, as well as life-threatening long-term complications such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic kidney failure, retinal damage, and nerve damage that carries a risk of limb amputation. Hypoglycemia is the case when the amount of glucose in the plasma is below the normal range. Hypoglycemia is associated with a variety of symptoms such as fine motor impairment, difficulty speaking, confusion, and life-threatening long-term complications such as loss of consciousness, seizures, or death. Since a cure is not yet possible, a permanent treatment that provides a certain level of blood glucose control is needed to keep blood glucose levels within the normal range at all times. Such blood glucose control is achieved by periodically supplying an external agent to the patient's body, thereby reducing elevated blood glucose levels.

[0018] Biologically active agents from the outside (e.g., insulin or its analogs) are generally administered by daily injections via a reusable transdermal liquid administration device (commonly referred to as an "insulin pen") or a subcutaneous syringe, and in some cases, by multiple daily injections (MDI) of rapid-acting insulin or long-acting insulin. Since injections are typically administered by a person with diabetes (PWD), self-monitoring of blood glucose and self-administration of insulin are required. PWDs who manage their own care using MDI often pre-plan their daily insulin injections based on their basal insulin requirements and, among other factors, external factors such as diet, exercise, and sleep. A typical dosing schedule will include the time of day of each dose, the type of insulin for each dose (e.g., but not limited to, rapid-acting, long-acting, or a mixture of rapid-acting and long-acting), and the amount of insulin for each dose. In addition, PWDs self-monitor their blood glucose and, if their blood glucose is too high, self-administer a "bolus" dose of rapid-acting insulin, and if their blood glucose is too low, consume carbohydrates (or in some cases, administer glycogen).

[0019] The "correct" insulin dose correlates with physiological factors such as blood glucose levels in the blood, a person's insulin sensitivity, and lifestyle factors such as diet (e.g., recently consumed carbohydrates that have not yet been metabolized to glucose and absorbed into the blood). Even with careful planning and self-monitoring, PWDs can miss doses, double-dose, or administer the wrong amount and / or type of insulin. Insufficient insulin can lead to hyperglycemia, and excessive insulin can lead to hypoglycemia.

[0020] Therefore, PWDs face a significant cognitive burden in self-monitoring their blood glucose and self-administering their insulin.

[0021] A variety of diabetes treatment devices for assisting self-monitoring (e.g., but not limited to, blood glucose meters (BGMs), continuous glucose monitors (CGMs), treatment applications) and a variety of diabetes treatment devices for assisting self-administration of insulin (e.g., but not limited to, injection pens, infusion pumps, and bolus calculators) have been developed.

[0022] FIG. 1 is a block diagram showing a system 100 (also referred to herein as the "treatment management system 100") for assisting drug treatment management and diabetes management, more generally, by one or more examples. As shown in FIG. 1, the system 100 can include a dosage injection device 102, a mobile device 104, a treatment application 106, an analyte sensor 108, a physiological sensor 110, a cloud service 112, and a network 114.

[0023] The dosage injection device 102 is configured for autonomous dosage injection as described herein and may also be referred to herein as the "autonomous dosage injection device 102". Here, when the dosage injection is described as "autonomous", it means that the dosage injection device 102 controls the calculation and delivery of the dosage associated with autonomous dosage injection without informing the user of the calculated dosage or the value of the delivered dosage. The dosage injection device 102 "makes the user aware of the administration" (i.e., notifies that the dosage has been administered), but does not make the user aware of the "calculated dosage" or the "delivered dosage". Accordingly, the user does not know at least the dose calculated or delivered via the dose injection device 102, but these amounts can be learned from other sources via, by way of non-limiting example, a therapeutic application 106 or a cloud service 112. In one or more examples, the dose injection device 102 can display an indication as to whether the calculated analyte value or the user's analyte level is within a predetermined range (e.g., without limitation, within a normal range not associated with risks such as hyperglycemic or hypoglycemic risks, within a range associated with a risk such as within a range associated with hyperglycemia, or within a range associated with hypoglycemia). In this way, the cognitive burden on the user of the dose injection device 102 can be reduced to monitor whether the user's analyte level, and more generally the user's medical condition, is being managed.

[0024] By way of non-limiting example, in one or more examples, 102 can display an indication as to whether the calculated glucose value or the user's blood glucose is within a predetermined range (e.g., without limitation, within a normal range not associated with hyperglycemic or hypoglycemic risks, within a range associated with hyperglycemia, or within a range associated with hypoglycemia). In this way, the cognitive burden on the user of the dose injection device 102 can be reduced to monitor whether the user's blood glucose value, and more generally, whether the user's diabetes is being managed.

[0025] The dose injection device 102 is configured to deliver a dose of a drug to the body. In one or more examples, the dose injection device 102 delivers the drug via, without limitation, a syringe such as a needle. In one or more examples, the dose injection device 102 is a syringe pen configured to deliver a drug to the subcutaneous tissue of a human body. In one or more examples, the dose injection device 102 may be a durable syringe pen configured to receive a pre-filled disposable drug cartridge.

[0026] In one or more examples, the agent may be insulin, an insulin analog, or a similar therapeutic agent, and the dosage injection device 102 may be configured to receive a pre-filled disposable insulin cartridge.

[0027] The mobile device 104 is a mobile computing device for receiving, transmitting, storing, processing, and / or displaying data and executing application software. Non-limiting examples of mobile computing devices include smartphones, personal data assistants (PDAs), tablet computers, laptop computers, or wearable computers (e.g., but not limited to, smartwatches or smart glasses). In one or more examples, the mobile device 104 includes, but is not limited to, a memory, at least one processor for executing application software stored in the memory (e.g., but not limited to, the treatment application 106), and a communication device for wirelessly communicating with one or more of the analyte sensor 108, the dosage injection device 102, the cloud service 112, or any physiological sensor 110.

[0028] The treatment application 106 is generally application software configured to perform various features and functions of treatment management discussed herein. The treatment application 106 can connect to and communicate with other components of the system 100 including the analyte sensor 108, the dosage injection device 102, the cloud service 112, and the physiological sensor 110. The treatment application 106 can function as an interface between a user (e.g., but not limited to, a PWD, a caregiver, a healthcare provider) and the PWD's pharmaceutical treatment. In one or more examples, the treatment application 106 can receive, aggregate, process, and present treatment data for a PWD, and present the treatment data to a user of the treatment application 106, for example, via a display (not shown) of the mobile device 104. The treatment data received, aggregated, processed, and presented by the treatment application 106 can include one or more of analyte data 116 received from the analyte sensor 108 (as described below), dosing data 118 received from the dosing injection device 102 (as described below), physiological data 122 received from the physiological sensor 110 (as described below), or treatment parameters 124 received from the cloud service 112.

[0029] The analyte sensor 108 is generally an apparatus configured to generate analyte data including values representative of analytes present in a person's bloodstream or body. Such presence of an analyte in a person's body is referred to herein as a "body analyte", and a value representative of a body analyte based at least in part on a sample taken from the body is referred to herein as an "analyte value".

[0030] As a non-limiting example, 108 can be considered a glucose sensor shown as glucose sensor 108'. The presence of glucose in a person's bloodstream, referred to herein as "blood glucose". In one or more examples, the glucose sensor 108' can be configured to estimate blood glucose using any suitable indication of glucose present in a person's bloodstream, such as glucose present in a person's vein or artery. As a non-limiting example, the glucose sensor 108' can be configured to sample the interstitial fluid glucose level of a user, determine a value representative of a blood glucose value based at least in part on the sample, and store glucose data including or based at least in part on an estimated glucose value (also referred to herein as a "glucose value"). In various examples, the glucose data generated by the glucose sensor 108 can further include information regarding the estimated glucose value, such as the date and time when the estimated glucose value was determined. The glucose sensor 108’ can be, by way of non-limiting example, a continuous glucose monitor (CGM), a flash glucose monitor (FGM), a blood glucose meter (BGM), or any other suitable sensor for determining a value representative of the blood glucose level in the body based at least in part on the interstitial fluid glucose level or an intermediate measurement thereof.

[0031] In one or more examples, the analyte sensor 108 can include means for communicating the analyte data 116 generated by the analyte sensor 108 to, for example, but not limited to, the therapy application 106 or the dosing injector device 102. By way of non-limiting example, the analyte data 116 in the analyte sensor 108 can communicate via near field communication (NFC), for example, via an NFC tag in the analyte sensor 108 and an NFC reader in the mobile device 104 or the dosing injector device 102.

[0032] The physiological sensors among the optional physiological sensors 110 include any sensors suitable for capturing information regarding a person's physiological state and providing that information to the mobile device 104 as physiological data 122. By way of non-limiting example, the physiological sensor 110 can include, but is not limited to, a heart rate monitor, a thermometer, or an electrocardiogram. The physiological sensor 110 can be an individual device that can communicate with the therapy application 106, or a sensor within a multi-purpose device for capturing multiple types of physiological data 122. In one or more examples, one or more of the physiological sensors 110 can be included in a smart device, and capturing the physiological data 122 can be one of several services performed by a smart device such as a smartwatch.

[0033] Figures 2A and 2D show an example of system 100 (hereinafter, systems 200a and 200d), and an assumed usage of systems 200a and 200d by user 206 according to another example.

[0034] Figure 2A shows an example of a dosage injection device 102 (hereinafter, dosage injection device 202) being swiped over an example of an analyte sensor 108 (hereinafter, analyte sensor 204) within the hand H of user 206 to receive analyte data (e.g., but not limited to, analyte data 116) from the analyte sensor 204 via NFC. In one or more examples, the analyte data may be received via an alternative channel (e.g., but not limited to, Bluetooth, Bluetooth Low Energy (BLE)), or via an example of a mobile device 104 (an exemplary mobile device not shown in Figure 2A).

[0035] In one or more examples, the dosage injection device 202 is configured to display information regarding the user's body analyte, e.g., one or more of an analyte value, an indication of whether the user's analyte value is within a desired range of the analyte value, an indication that a dosage is ready, or an indication that a dosage has been delivered.

[0036] As a non-limiting example, the dosage injection device 202 may be configured to display information regarding the user's blood glucose, e.g., one or more of a glucose value, an indication of whether the user's glucose value is within a desired range of the glucose value (e.g., normal, out-of-range blood glucose, out-of-range hyperglycemic), an indication that a dosage is ready, or an indication that a dosage has been delivered.

[0037] Figures 2B and 2C are diagrams showing exemplary display screens, here display screen 200b and display screen 200c, for a dosage injection device 102, such as dosage injection device 202, according to one or more examples, by way of non-limiting example.

[0038] In one or more examples, display screens 200b and 200c can be configured for touch or pressure sensing, by way of non-limiting example, incorporating a volumetric or resistive sensing system, which facilitates user interaction with a user interface that more generally enables a user to interact with dosage injection device 102 and system 100. In one or more examples, a portion of display screens 200b and 200c, or a device coupled to display screens 200b and 200c, can include buttons, dials, or switches that provide some or all of the functionality of user interfaces 210 and 218.

[0039] In one or more examples, display screen 200b may display a user interface 210 that enables a user to interact with dosage injection device 102. User interface 210 can include a dosage preparation completion notification 212, a dosage preparation completion confirmation 214, and a dosage preparation completion confirmation 214.

[0040] In one or more examples, dosage preparation completion notification 212 is configured to notify the user that the dosage of the pharmaceutical is ready to be delivered. In one or more examples, dosage preparation completion notification 212 can be a visual indicator (e.g., a blinking light, an icon, display text (e.g., but not limited to, "Dosage Preparation Complete")), and optionally can be accompanied by an audible indicator (e.g., but not limited to, a predefined tone audible to a person). In one or more examples, the dosage preparation completion notification 212 does not include the value of the target dosage or any other information regarding the target dosage. This reduces user confusion because most users only need to recognize that the dosage is ready to be injected and can assume that the target dosage has been calculated to appropriately control their analyte levels. As a non-limiting example, a typical PWD may assume that a target dosage of insulin has been calculated to appropriately control its glucose level.

[0041] In one or more examples, the last analyte value information 216 is configured to provide the user with information regarding the last (e.g., but not limited to, most recent) analyte value representing the user's blood glucose level. Such an analyte value may, as a non-limiting example, be included in or at least partially based on analyte data 116 received from an analyte sensor, at least partially in response to the dosage injection device 202 being swiped by the analyte sensor as shown in FIG. 2A.

[0042] As a non-limiting example, the last analyte value information 216 may include, as a non-limiting example, a glucose value included in or at least partially based on glucose data received from a glucose sensor, at least partially in response to the dosage injection device being swiped by the glucose sensor. Such a glucose value may be in milligrams per deciliter (mg / dL).

[0043] In some cases, when the dosage injection device displays an analyte value, the user may be distracted or confused. For example, if the user assumes that the dosage injection device has calculated the appropriate dosage of insulin and notified the user that the dosage is ready at the appropriate time, the purpose of a particular analyte value may confuse the user and potentially delay treatment. In some cases, the indication that the latest analyte value has been received may be sufficient for the user to initiate the operation of reading the analyte data 116 from the analyte sensor 108 if the latest value has not been received.

[0044] In one or more examples, the last analyte value information 216 may not present the actual value of the blood glucose level, but rather an indication that an analyte value was received within a threshold period during which it is likely safe for the user to administer the drug, or that no analyte value was received within a threshold period during which it may not be safe for the user to administer the drug, and the latest analyte value should be updated before administering the drug.

[0045] In one or more examples, the dosage preparation completion confirmation 214 is configured such that the user can confirm with the dosage injection device 102 that the user is ready to deliver the dosage of the drug. Since the user does not know the target dosage calculated by the dosage injection device 102, the dosage preparation completion confirmation 214 does not confirm or verify the calculated target dosage associated with the dosage preparation completion notification 212.

[0046] Upon receiving the dosage preparation completion confirmation 214, the dosage injection device 102 can optionally initiate the injection of insulin if all other conditions are met.

[0047] In one or more examples, the dosage injection device 102 controls the user interface 210 to generate the dosage preparation completion notification 212 at least partially in response to the determination of the target dosage. In one or more examples, the target dosage utilized by the dosage injection device 102 to deliver the dosage of the drug may be different from the target dosage utilized to generate the dosage preparation completion notification 212. As a non-limiting example, the dosage injection device 102 can change the value of the target dosage in response to various conditions, such as receiving a new analyte value indicating a different target dosage of the drug. In particular, since the value of the target dosage is not provided to the user, the user may not be aware of the change.

[0048] As a non-limiting example, the target dosage can be for the target dosage of insulin. The dosage injection device 102 can be configured to change the value of the target dosage of insulin in response to conditions such as receiving an announcement of a meal after a notification is generated but before the insulin dosage is injected, or receiving a new glucose value indicating a different target dosage of insulin.

[0049] FIG. 2C is a diagram showing an exemplary display screen 200c of the dosage injection device 102 according to one or more examples. The exemplary display screen of the dosage injection device 102 may be configured as the display screen 200B, the display screen 200c, or may be configured to alternately display the display screen 200b or the display screen 200c.

[0050] In one or more examples, the display screen 200c may display a user interface 218 that enables the user to interact with the dosage injection device 102. The user interface 218 includes the last glucose value information 222 and the meal announcement 220. The last glucose value information 222 may be configured similarly to the last glucose value information 216.

[0051] In one or more examples, the meal announcement 220 is configured to be able to provide an indication that the user has recently consumed a meal. The meal announcement 220 can optionally include a size classification, for example, but not limited to, classifications of meal announcements such as "small", "medium", or "large". The amount of carbohydrates associated with the meal size may be preset, and the amount may be personalized based at least in part on values provided by the treatment application 106 or the cloud service 112. The personalized value may be based at least in part on the user's average meal size. As a non-limiting example, the treatment application 106 can include or communicate with a meal tracking application and can infer the meal sizes of small, medium, and large meals based on meal data entered into the meal tracking application. In another example, the user can use the treatment application 106 to enter a value for the amount of carbohydrates associated with a small, medium, or large meal.

[0052] In one or more examples, the meal announcement 220 may be associated with a number of carbohydrates personalized for the user based on other user-specific dosing parameters (e.g., total daily dose of long-acting insulin (e.g., U / day), total daily dose of insulin (e.g., total of long-acting and rapid-acting), carbohydrate-to-insulin ratio, insulin sensitivity factor, glucose setting value, or a combination thereof) entered by the user via the treatment application 106 for the system 100. In some cases, the carbohydrate value assigned to the meal announcement 220 and each category of the meals included therein may be personalized over time based on an estimated amount of each meal consumed when the meal announcement 220 button was selected, based on the glucose response after each meal was consumed. In some cases, the number of carbohydrates assigned to each preset icon or button may optionally be displayed with any amount less than 5 grams of carbohydrates rounded. In one or more examples, the number of carbohydrates for each button is not displayed. In one or more examples, the number of carbohydrates assigned to each user-selectable icon or button can be initially set to a predetermined starting point or determined based on the entered user information, and then iteratively adjusted up or down over time based on the selected meal amount and blood glucose response to the bolus.

[0053] In one or more examples, the initial settings of the meal announcements 220 may be preset with a predetermined value or range (e.g., small = 20 g or 15 - 25 g, medium = 30 g or 30 - 45 g, large = 50 g or 50 - 75 g). Additionally or alternatively, the initial settings may be set based on the entered user data or based on one or more user-specific dosage parameters entered via the therapy application 106. In some cases, the initial settings of one or more user-selectable icons or buttons may be based on the initially entered or determined and programmed total daily long-acting insulin (TDLAI) dosage (e.g., U / day) for a day. For example, the relationship between the LAI dosage [U / day] characterized by a line corresponding to the major axis of the superellipse and the geometric mean meal amount [g] is μ*MS = 12.1*BR0.387. The relationship between the geometric mean meal amount [g] and the geometric standard deviation of the meal amount is σ*MS = 1.92 - μ*MS / 186, where MS can represent the meal amount and BR can represent the basal amount of insulin. Thus, the initial meal amount groups can correspond to a predetermined percentile of the meal amount distribution by combining the above equations and, optionally, rounding the meal amount groups to less than 1 gram, 5 grams, or 10 grams. In some cases, the relationship between a typical meal amount and other user-specific dosing parameters can be determined according to demographics. In some cases, the number of carbohydrates associated with each user-selectable icon or button can be displayed on and / or adjacent to the user-selectable icon or button, which can help the user understand how to use the insulin delivery device or system and can avoid deskilling the user. For example, checking the number of carbohydrates assumed for each meal amount can help a user who thinks about meals in terms of carbohydrates get used to using the button to indicate the meal amount. Furthermore, by starting with a displayed number that is rounded off for less than 5 grams, the user can perceive that precision is not required, thus reducing the user's cognitive burden. Furthermore, since the system iterates to personalize the amount of carbohydrates for each specific user-selectable icon or button, the system can adjust these numbers in smaller units (e.g., 1 gram) to demonstrate to the user that the system is adjusting the number of carbohydrates associated with the user-selectable icon or button.

[0054] In particular, neither display screen 200b nor display screen 200c contains information regarding the target dose to be delivered or the actual dose delivered. In some cases, the user may be confused by these values because, as a non-limiting example, the user assumes that an appropriate amount for the target dose is calculated and delivered.

[0055] In particular, one of ordinary skill in the art will understand that display screen 200c may include inputs for announcements in addition to or as an alternative to meal announcement 220 to announce physiological or lifestyle conditions that affect analyte levels in a person's body.

[0056] Figure 2D shows a user 206 injecting a drug (208) via an exemplary dosage injection device 102, here the dosage injection device 202. Further information regarding the various components of this dosage injection device 202 is shown in FIG. 3.

[0057] FIG. 3 is a block diagram of an apparatus 300 for automatically injecting a dosage of a drug according to one or more examples. Apparatus 300 is a non-limiting example of the dosage injection device 102 of FIG. 1 or its components. As shown in FIG. 3, apparatus 300 can include a drive mechanism 302, a chamber 304, a position sensor 310, a drive controller 312, and a logic circuit 324. Chamber 304 may be configured to hold an optional cartridge 306 having a plunger 324.

[0058] Logic circuit 314 is generally configured to calculate a target dosage 318 for delivery to a user of apparatus 300, or more generally a user of dosage injection device 102, as a non-limiting example. In one or more examples, logic circuit 314 can calculate the value of target dosage 318 at least in part in response to treatment parameters 326 and optional diet or other lifestyle data 328. Treatment parameters 326 can include user-specific dosage parameters. In one or more examples, user-specific dosage parameters can include, but are not limited to, an insulin sensitivity factor (ISF), a carbohydrate ratio (CR), a daily dosage of long-acting insulin (LAI), or a current BGL, for example, for insulin therapy for treating diabetes.

[0059] In one or more examples, the value of at least some of the treatment parameters 326 may be updated based at least in part on the value of the treatment parameters 120 provided by the treatment application 106. In one or more examples, the value of at least some of the treatment parameters 326 may be updated by the logic circuit 314.

[0060] The logic circuit 314 may be configured to provide a notification request 330 for a notification to indicate to the user that the dosage is ready. The logic circuit 314 can provide the notification request 330 at least in response to calculating the value of the target dosage. Upon receiving the administration confirmation 336, the logic circuit 314 can send a request to deliver the target dosage 318 to the drive controller 312. In one or more examples, the logic circuit 314 does not send a request to deliver the target dosage 318 unless it receives an administration confirmation 336 related to the target dosage 318, and in one or more examples, does not send a request to deliver the target dosage 318 unless it receives the administration confirmation 336 within a predetermined period of calculating the value of the target dosage 318 or sending the notification request 330.

[0061] The chamber 304 is a space or region at least partially defined within the housing of the device 300, or more generally within a dosage injection device that includes the device 300 (the housing not shown), and receives and holds the drug cartridge 306. In one or more examples, the chamber 304 is configured to optionally receive a filled cartridge 306 for receiving a filled cartridge 306, discharging an empty cartridge 306 (e.g., but not limited to, having an insufficient amount of drug remaining for the dosage), and replacing the empty cartridge 306 (i.e., "replacement cartridge 306"). In one or more examples, the chamber 304 may be configured to non-removably hold the cartridge 306 until the cartridge 306 is depleted. One or more walls of the body of the cartridge 306 may surround a plunger 324 disposed within the cartridge 306 to form a fluid reservoir of the cartridge 306. The gasket of the plunger 324 can be sized / dimensioned to form a tight (e.g., but not limited to, airtight or fluid-tight) seal within the cartridge 306 while still allowing the plunger 324 to move within the cartridge 306. In the case of a cartridge 306 that has not discharged fluid internally, when the plunger 324 moves, the fluid within the cartridge 306 is pushed out towards an interface for distributing the fluid located at the opposite end of the cartridge 306. Generally speaking, the volume of the fluid reservoir of the cartridge 306, when pre-filled, is larger than the volume in the discharged state.

[0062] The drive mechanism 302 is generally configured to apply a force 308 to the plunger 324 of the received cartridge 306, advance the plunger 324 within the cartridge 306 by the force 308, and distribute fluid therefrom. In one or more examples, the drive mechanism 302 may include a piston that is operably coupled to the plunger 324 of the cartridge 306, and the force 308 is applied to the plunger 324 via the piston. In one or more examples, the drive mechanism 302 can include an electric motor such as a DC or AC motor. In one or more examples, the drive mechanism 302 may be a current-controlled electric motor, a voltage-controlled electric motor, or a pulse-width-controlled electric motor. The drive mechanism 302 may be configured to generate the force 308 at least partially in response to a control signal such as the control signal 322.

[0063] The drive controller 312 is generally configured to generate a control signal 322 for the drive mechanism 302. The control signal 322 can include a first control signal for causing the drive mechanism 302 to generate a force 308 and / or to apply the force 308 to the plunger 324, and a second different control signal for causing the drive mechanism 302 not to generate the force 308 or to stop generating it, and / or for not applying the force 308 to the plunger 324 or for stopping the application of the force. Using the control signal 322, the drive controller 312 can control the length of the period during which the drive mechanism 302 applies the force 308 to the plunger 324 and, indirectly, the amount of fluid dispensed from the cartridge 306.

[0064] The drive controller 312 can generate the control signal 322 in response, at least in part, to one or more of the target dosage 318 generated by the logic circuit 314 or the position signal 316 generated by the position sensor 310. The distance the plunger 324 moves during the dispensing operation generally corresponds to the displacement of the fluid and thus the amount of drug delivered. In one or more examples, the drive controller 312 can monitor the position of the plunger 324 as an indication of the amount of drug delivered based on the position signal 316 received from the position sensor 310.

[0065] In one or more examples, the drive controller 312 can provide a signal indicating the actual dosage (e.g., but not limited to, the dispensed dosage 332) delivered to the logic circuit 314. In particular, the dispensed dosage 332 delivered during the dispensing operation may be different from the target dosage 318 required by the logic circuit 314, and thus the value of the dispensed dosage 332 provided by the drive controller 312 may be different from the value of the target dosage 318 required by the logic circuit 314.

[0066] The difference between the dispensed dosage 332 and the target dosage 318 can be due to, as non-limiting examples, non-linearity of the drive controller 312, the drive mechanism 302, the plunger 324 and the cartridge 306, or the position sensor 310. The logic circuit 314 can provide the value of the dosage 332 that is delivered to the treatment application 106 along with the dosing data 334 / dosing data 118.

[0067] In one or more examples, the drive controller 312 can provide the delivered dosage 332 at least partially in response to the detection of the delivery of the dosage. The drive controller 312 can include dosage detection logic (not shown) for detecting the delivery of the dosage using two or more positions of the plunger 324 indicated by the position signal 316. As a non-limiting example, the drive controller 312 can store a first position of the plunger 324 indicated by the position signal 316 and later compare it to a second position of the plunger 324 indicated by the position signal 316. The drive controller 312 may detect the dosage at least partially in response to a determination that the first position and the second position are different.

[0068] The position sensor 310 can generate the position signal 316 at least partially in response to the presented position 320 of the plunger 324. In one or more examples, the position sensor 310 can be any sensor suitable for reliably detecting the position of the plunger 324 and providing a lockout signal 510 indicating the presented position 320.

[0069] In one or more examples, the position signal 316 can be a sensor module that interrogates the plunger 324 and / or the cartridge 306 using light. Such a sensor module includes one or more light sources (e.g., but not limited to, light emitting diodes (LEDs)) arranged to emit electromagnetic radiation, one or more light guides (e.g., but not limited to, light tubes, light pipes, light columniators) for dispersing the electromagnetic radiation across the chamber 304, and one or more fixed detectors for optically coupling to the one or more light guides / sources via the dispersed electromagnetic radiation. When an object made of an opaque material (a material that inhibits the passage of light), such as the material of the plunger 324, is located in the path of the dispersed light, the object interferes with the optical coupling between the detector and the light guide / source. The output of each detector changes at least partially in response to the disrupted optical coupling. Since the position of the detector is fixed, the changed output of each detector can be correlated (e.g., but not limited to, via a look-up table) by the logic of the drive controller 312 to the specific position of the object that interferes with the optical coupling. In the case of the plunger 324 moving through the cartridge 306, when the plunger interferes with the optical coupling of each detector, the position of the plunger 324 can be estimated and provided via the position signal 316.

[0070] In one or more examples, for a given dosing operation, the drive controller 312 can know the initial or starting position of the plunger 324. When instructed by the logic circuit 314 to deliver a target dose 318, the logic of the drive controller 312 can determine the end position of the plunger 324 at least partially in response to the target displacement amount corresponding to the target dose 318, the starting position of the plunger 324, and the total displacement amount per unit displacement of the plunger 324. In one or more examples, the end position can substantially correspond to the position of each detector of the position sensor 310.

[0071] In one or more examples, the placement of the detectors of the position sensor 310 may be preselected such that the spacing between the detectors corresponds to a conventionally used dosage of the drug, a multiple of the conventionally used dosage of the drug, or a fraction of the conventionally used dosage of the drug. As a non-limiting example, the spacing between the detectors can be selected to correspond to 0.25 units of insulin, where a unit of insulin corresponds to 1 international unit of insulin or 0.0347 milligrams of insulin.

[0072] FIG. 4 is a diagram of a position sensor device 400 (position sensor apparatus 400) according to one or more examples. As shown in FIG. 4, the position sensor device 400 includes light sources 402a, 402b, 402c, and 402d arranged for optical coupling (optical couplings 412a, 412b, 412c, and 412d) with detectors 404a, 404b, 404c, and 404d. Light guides are omitted for ease of explanation but may optionally be included.

[0073] Each of the spacings 414, 416, and 418 between detectors 404a, 404b, 404c, and 404d may be of substantially the same length and generally corresponds to a predetermined amount of insulin expected to be dispensed by advancing plunger 408 within cartridge 406 (410) over a distance substantially equal to spacings 414, 416, and 418. In one or more examples, the spacing may be selected to correspond to a small number of units of insulin (e.g., but not limited to, 0.1 unit, 0.2 unit, 0.25 unit, 0.5 unit), a single unit of insulin (e.g., but not limited to, 1 unit), or a plurality of units of insulin (e.g., but not limited to, 10 units, 20 units, 30 units, 40 units, 50 units, 60 units, 70 units, 80 units, 90 units, or 100 units).

[0074] During a given dispensing operation, if plunger 408 obstructs the optical coupling between detector 404b and light source 402b, detector 404b generates a changed output 420. Sensor logic 422 determines which of detectors 404a - 404d generated the changed output 420 and the output position signal 424, and the output position signal 424 indicates the position of plunger 408. The position signal 424 can be utilized to determine that the plunger 408 is disposed at a distance equal to the interval 414 from its starting position for a given dosing operation.

[0075] In one or more examples, the entire detector / light source pair can be actuated during the dosing operation. However, in one or more examples, a number of detector / light source pairs less than the entire detector / light source pair shown in FIG. 4 can be actuated for the dosing operation. As a non - limiting example, by actuating fewer detector / light source pairs than the entire set, the power utilized by device 300 to perform the dosing operation can be reduced.

[0076] As a non - limiting example, drive controller 312 can indicate the target end position of the plunger for a given dosing operation before generating the control signal 322 to initiate the dosing operation. Sensor logic 422 in position sensor 310 determines which of detectors 404a, 404b, 404c, and 404d corresponds to the target end position 426 and can actuate only the detector / light source pair of the determined detector. If the plunger 408 obstructs the optical coupling between the actuated detector / light source pair, the determined detector is read by sensor logic 422 and generates a changed output utilized to generate the position signal 424.

[0077] FIG. 5 is more generally a simplified block diagram showing device 500 for skin contact detection as a condition for performing a dosing operation in device 300 and dosing syringe device 102. As shown in FIG. 5, the apparatus 500 can include a detector 504, a changed output 506, a lockout circuit 508, a drive mechanism 512, a needle housing 514, and a user's body 516.

[0078] The detector 504 is generally configured to detect a direct physical contact 518 between the needle housing 514 and the user's body 516 by a display of the shown contact 502. Assuming that when the user is ready to inject an insulin dose, the needle housing 514 is arranged to be in direct physical contact 518 with the user's body 516 (e.g., but not limited to, the skin), the detector 504 changes from a first state corresponding to no physical contact between the needle housing 514 and the user's body 516 to a second stage corresponding to direct physical contact between the needle housing 514 and the user's body 516, and can be configured to generate a changed output 506 in response to a change in the shown contact 502.

[0079] In one or more examples, the detector 504 may be or may include a capacitance sensor, and the direct physical contact between the needle housing 514 and the user's body 516 may be indicated by a change in the capacitance of the needle housing 514. As a non-limiting example, when the needle housing 514 is not in direct physical contact with the user's body 516, the needle housing 514 may exhibit a first capacitance, and when the needle housing is in direct physical contact with the user's body 516, it may exhibit a second capacitance different from the first capacitance. The detector 504 can detect a change in capacitance from the first capacitance to the second capacitance and generate a changed output 506 to indicate that the state of the shown contact 502 changes from a state of no direct physical contact to a state of direct physical contact.

[0080] The lockout circuit 508 is generally configured to generate a lockout signal at least partially in response to the output of the detector 504. More specifically, the lockout circuit 508 asserts the lockout signal 510 at least in part in response to the output of the detector 504 indicating no direct physical contact 518 between the needle housing 514 and the user's body 516, and de-asserts the lockout signal 510 at least in part in response to the output of the detector 504 indicating direct physical contact 518 between the needle housing 514 and the user's body 516.

[0081] In one or more examples, the enable input of the drive mechanism 512 is coupled to receive the lockout signal 510. The connection between the lockout circuit 508 and the enable input of the drive mechanism 512 is configured such that when the lockout signal 510 is asserted, the enable input is deactivated, and when the lockout signal 510 is de-asserted, the enable input is activated. When the enable input is activated, the drive mechanism 512 can operate to apply force to a plunger (e.g., but not limited to, plunger 324 of FIG. 3), and when the drive mechanism 512 is deactivated, the drive mechanism cannot operate to apply force to the plunger (e.g., but not limited to, plunger 324).

[0082] In one or more examples, the disclosed dosage injection device may be configured to alternately enable or disable dosage injections at least in part in response to detection of dosage conditions. The dosage conditions may be preconfigured rules in the disclosed dosage injection device that are satisfied to deliver a dosage via the dosage injection device 102.

[0083] In one or more examples, when the dosage conditions are not detected, the injection mechanism is disabled. When the dosage conditions are detected, the injection mechanism is enabled.

[0084] In one or more examples, when the administration conditions are not detected, the logic circuit (e.g., but not limited to, logic circuit 314) of the dosage injection device does not generate a dosage preparation completion notification. When the administration conditions are detected, the logic circuit of the dosage injection device can generate a dosage preparation completion notification. The administration conditions can include first and second administration conditions. The first administration condition is an important administration condition. In one or more examples, the logic circuit 314 requests the target dosage 318 only when it detects that all possible first administration conditions are met. The second administration condition is, individually, an unimportant administration condition. In one or more examples, the logic circuit 314 requests the target dosage 318 only when it detects that the threshold number of second administration conditions are met.

[0085] Non-limiting examples of the first administration condition include meal announcement, dosage preparation completion confirmation, administration warning, the state of the injection device, and the last analyte value. Non-limiting examples of the first administration condition in the context of a user with diabetes include meal announcement, dosage preparation completion confirmation, administration warning, the state of the injection device, and the last glucose value. Such examples are when the effective current glucose value exceeds a predetermined threshold corresponding to the risk of hypoglycemia (e.g., but not limited to, 50 / 60 / 70 mg / dl), the indication of a malfunction of the dosage injection device is "false", and the dosage preparation completion confirmation is "true", etc., the indication of skin contact detection is "true". Non-limiting examples of the second administration condition include heart rate, exercise, meal timing, sleep, allergies, menstruation, smoking, temperature, weight, hormones, stress, caffeine and alcohol intake, and medications. Non-limiting examples of the second administration condition in the context of a user with diabetes include heart rate, exercise, meal timing, sleep, allergies, menstruation, smoking, temperature, weight, hormones, stress, caffeine and alcohol intake, and medications.

[0086] Figure 7 is a simplified block diagram of a user interface 700 for a user to interact with the disclosed dosage injection system and device, according to one or more examples. In one or more examples, the user interface 700 may be provided via any suitable hardware including, but not limited to, icons, buttons, lights, or dials on a touch display.

[0087] The user interface 700 can include one or more inputs 702 for the user to provide meal announcements 710 and dosage preparation completion confirmations 712 to the autonomous dosage injection system 802. The inputs 702 of the user interface 700 can be any suitable input for the user to make meal announcements or delivery confirmations, such as clickable buttons or icons on a touchpad that respectively correspond to meal announcements 710 for small, medium, or large meals. In another example, the input 702 can be a dial having an associated analog or digital display that changes as the user rotates the dial. As the user rotates the dial, the associated display can present options to select meal announcements 710 for small, medium, or large meals.

[0088] The user interface 700 can include one or more outputs for presenting information to the user. In the specific non - limiting example shown in FIG. 7, the user interface 700 includes an output 706 indicating the state of the injection device 714 and an output 708 indicating a dosage warning 716. The state of the injection device 714 shown to the user may include whether the autonomous dosage injection system 802 is enabled or disabled. As a non - limiting example, the autonomous dosage injection system 802, as described with reference to FIG. 5, is disabled when no skin contact is detected and enabled when skin contact is detected, and such a state (disabled or enabled) is indicated by the output 706. As another non-limiting example, since the first administration condition or the second administration condition is not detected, the state of the injection device 714 may be disabled.

[0089] The output 708 can present a dosing warning 716 to the user. The dosing warning notifies the user whether it is time to administer insulin or not. The output 718 can present the last glucose value 720 to the user. The last glucose value 720 notifies the user as described above.

[0090] Figure 8 is a simplified block diagram of a dosing injection device 800 according to one or more examples. In the specific non-limiting example shown in Figure 8, the dosing injection device 800 includes an autonomous dosing injection system 802, a user interface 804, and a communication device 806.

[0091] The autonomous dosing injection system 802 is generally a system or device configured to autonomously inject an insulin dose, such as the device 300.

[0092] The user interface 804 is for the user to interact with the dosing injection device 800 according to one or more examples.

[0093] The communication device 806 is a communication device for the dosing injection device 800 to wirelessly communicate with the analyte sensor 108 and the treatment application 106.

[0094] In one or more examples, different communication interfaces can be provided to communicate with components of the autonomous dosing injection system and devices or applications remote from the dosing injection device. FIG. 9 is a simplified block diagram showing a system 900 that utilizes a first communication interface for communicating with components of an autonomous dosage injection system and a second communication interface for communicating with a device or application remote from the dosage injection device. In the non-limiting example shown in FIG. 9, system 900 includes a first communication interface 902, a second communication interface 904, components 906 of an autonomous dosage injection system, a device or application 908 remote from the dosage injection device, and a logic circuit 910.

[0095] The first communication interface 902 is an interface for a communication system (e.g., but not limited to, a communication bus) for communicating with components 906 of an autonomous dosage injection system. As a non-limiting example, logic circuit 314 may be configured to use the first communication interface 902 to provide a target dosage 318 to drive controller 312 and a notification 330 to user interface 804.

[0096] The second communication interface 904 is an interface for a communication system (e.g., but not limited to, a communication bus) for communicating with a device or application 908 remote from the dosage injection device. As a non-limiting example, logic circuit 910 may use the second communication interface 904 to communicate with treatment application 106 via communication device 806, and more specifically, provide dosage data 118 to treatment application 106.

[0097] FIG. 10 is a diagram showing an exemplary display screen 1000 of a mobile device (e.g., but not limited to, mobile device 104 that executes treatment application 106) that executes a treatment application. As described above, in one or more examples, the display screen on dosage injection device 102 does not display the value of the target dosage or the delivered dosage. In some cases, the user may wish to view such information, and thus, or in more cases, the treatment application 106 can receive the target dose and the dose delivered from the dose injection device 102, and the user interface 1002 of the treatment application can display one or more of the time of the last dose in field 1004, the target dose in field 1006, or the dose delivered in field 1008. This information may be updated from time to time based at least in part on the dosing data 118 transmitted by the dose injection device 102.

[0098] FIG. 11 is a swimlane diagram showing a process 1100 for controlling dosing according to one or more examples. A logic circuit 1102 (e.g., but not limited to, logic circuit 314) and a user interface 1104 (e.g., but not limited to, user interface 210) are shown.

[0099] In operation 1106, the logic circuit 1102 calculates a dose, i.e., the target dose. In operation 1108, the logic circuit 1102 sends a request to the user interface 1104 to provide a dose preparation complete notification. The dose preparation complete notification is to notify the user that the injection of the dose is ready. In operation 1110, the user interface 1104 provides the dose preparation complete notification. As described above, the dose preparation complete notification 212 may be a visual indicator and an audible indicator recognizable by the user to indicate that the insulin dose is ready. In operation 1112, the logic circuit 1102 detects a timeout state. The timeout state occurs when a predetermined time has elapsed since the logic circuit 1102 requested the dose preparation complete notification in operation 1108 without receiving a dosing confirmation from the user. The predetermined duration may be set to any desired time interval. For example, it can be 15 minutes, 30 minutes, 45 minutes, or 1 hour. The time interval is not limited, but can be set based on any of several factors, including the latest analyte value (since it is the latest analyte value within the normal range, waiting for a normal amount of time) or the trend of the analyte value (since an increase in the analyte value indicates an urgent need to administer insulin, the time interval is set shorter than the normal time interval). In operation 1114, in response to detecting the timeout state in operation 1112, the logic circuit 1102 sends a request to the user interface 1104 not to provide a dosage preparation completion notification. In response to the request not to provide a dosage preparation completion notification, the user interface 1104 stops providing the dosage preparation completion notification in operation 1116. In operation 1118, the logic circuit 1102 optionally ignores the user confirmation received by the logic circuit 1102 while in timeout or while a dosage confirmation request is pending.

[0100] FIG. 12 is a swimlane type flow diagram showing a process 1200 for providing a dosage of insulin that complements process 1100. In operation 1208, the logic circuit 1102 calculates a target dosage. In operation 1210, the logic circuit 1202 sends a request to the user interface 1204 to provide a dosage preparation completion notification. In operation 1212, the user interface 1204 provides a dosage preparation completion notification. In operation 1214, the user interface 1204 sends a dosage confirmation initiated by a user interacting with the user interface 1204. In operation 1216, in response to the dosage preparation completion dosage confirmation, the logic circuit 1202 requests the drive controller 1206 to provide a dosage corresponding to the calculated dosage.

[0101] Figure 13 is a swimlane-type flowchart showing a process 1300 for injecting a dosage of insulin according to one or more examples. A detector 1302, a lockout circuit 1304, and a drive mechanism 1306 are shown. In operation 1308, the lockout circuit 1304 instructs the drive mechanism 1306 to disable (e.g., but not limited to, de-asserting an enable signal). When disabled, the drive mechanism 1306 does not respond to requests to deliver a dosage. In operation 1310, the detector 1302 detects a direct physical contact between a required housing (e.g., but not limited to, the needle housing 514) and the user's body (e.g., but not limited to, the user's body 516). In operation 1312, the detector 1302 notifies the lockout circuit 1304 that a direct physical contact has been detected. In response to the notification that a direct physical contact has been detected, in operation 1314, the lockout circuit 1304 instructs the drive mechanism 1306 to enable (e.g., but not limited to, asserting an enable signal).

[0102] Figure 14 is a swimlane-type flowchart showing a process 1400 for injecting a dosage of insulin according to one or more examples. A detector 1402, a lockout circuit 1404, and a drive mechanism 1406 are shown. In operation 1408, the lockout circuit 1404 instructs the drive mechanism 1406 to disable (e.g., but not limited to, de-asserting an enable signal). When disabled, the drive mechanism 1406 does not respond to requests to deliver a dosage. In operation 1410, the detector 1402 notifies the lockout circuit 1404 that a first dosing condition has been detected. In response to the notification that a first dosing condition has been detected, in operation 1412, the lockout circuit 1404 instructs the drive mechanism 1406 to enable (e.g., but not limited to, asserting an enable signal).

[0103] FIG. 15 is a swimlane diagram showing a process 1500 for injecting a dosage of insulin according to one or more examples. A detector 1502, a lockout circuit 1504, and a drive mechanism 1506 are shown. In operation 1508, the lockout circuit 1504 instructs the drive mechanism 1506 to disable (e.g., without limitation, deassert an enable signal). When disabled, the drive mechanism 1506 does not respond to requests to deliver a dosage. In operation 1510, the detector 1502 notifies the lockout circuit 1504 that a threshold number of second dosing conditions have been detected. In response to the notification that the first dosing condition has been detected, in operation 1512, the lockout circuit 1504 instructs the drive mechanism 1506 to enable (e.g., without limitation, assert an enable signal).

[0104] FIG. 16 is a diagram of an injection pen 1600 configured as a dosage injection device 102 according to one or more examples.

[0105] FIG. 16 shows an injection pen 1600 including a housing 1604 and a syringe 1610. The walls of the housing 1604 may be relatively opaque to select (e.g., without limitation, filter) only the wavelengths of electromagnetic radiation (e.g., without limitation, infrared or microwave radiation) that pass therethrough. The housing 1604 can define an internal volume 1612 (e.g., a reservoir) or chamber for receiving a medicated disposable cartridge 1606. The filled cartridge 1606 can include an actuator 1608, e.g., a plunger portion configured to be in fluid communication with the medicament and to deliver a predetermined amount of the medicament to the user. The actuator 1608 can also include a drive mechanism, a drive controller, and a position sensor configured to dispense a variable amount of the medicament, e.g., without limitation, by a logic circuit, as described with respect to device 300. The syringe 1610 (e.g., but not limited to, a needle within a needle housing) may be configured to penetrate the user's tissue for intramuscular, subcutaneous, and / or intravenous delivery of a medicament. In one or more examples, the injection pen 1600 may further include, for example, a communication device for transmitting and receiving data with an analyte sensor or a therapeutic application, a power source (e.g., but not limited to, a battery) for powering the actuator 1608, and a user interface 1602 that enables the user to interact with the injection pen 1600 (e.g., but not limited to, display screen 200B or display screen 200C), and the communication device. In one or more examples, the injection pen 1600 and the dosage injection device 102 may more generally be a durable injection device that can be used in a residence.

[0106] Figures 17A - 17F show various perspective views of an exemplary dosage injection device 108, according to one or more examples.

[0107] Examples of self - administered dosages can be utilized in conditions other than diabetes. For example, self - administered dosages can be used for anticoagulants such as heparin, palliative care analgesics, treatment of growth hormone deficiency (GHD) such as somatotropin, and infertility treatments such as human chorionic gonadotropin (hCG) or follicle stimulating hormone (FSH). For these treatments, those skilled in the art will understand that the first and second dosing conditions discussed herein can be adjusted for conditions that affect treatment and management.

[0108] As used in this disclosure, the terms "module" or "component" may refer to a particular hardware implementation configured to perform the operations of the module or component, and / or a software object or software routine stored on and / or executed by general-purpose hardware of a computing system (e.g., but not limited to, a computer-readable medium, a processing device). In one or more examples, the different components, modules, engines, and services described in this disclosure may be implemented as objects or processes that execute on a computing system (e.g., as separate threads). Some of the systems and methods described in this disclosure are generally described as being implemented in software (stored and / or executed by general-purpose hardware), but specific hardware implementations or combinations of specific software implementations and specific hardware implementations are also possible and contemplated.

[0109] As used in this disclosure, the term "combination" with respect to a plurality of elements can include either a combination of all elements or a partial combination (sub-combination) of some of the elements. For example, the phrase "A, B, C, D, or combinations thereof" can refer to A, B, C, or D; to each combination of A, B, C, and D; to any partial combination of A, B, C, or D such as A, B, and C; to A, B, and D; to A, C, and D; to B, C, and D; to A and B; to A and C; to A and D; to B and C; to B and D; or to C and D.

[0110] The terms used in this disclosure and in particular in the appended claims (e.g., the body of the appended claims) are generally intended to be open terms (e.g., without limitation, the term "including" should be construed as "including but not limited to", the term "having" should be construed as "having at least", and the term "includes" should be construed as "including but not limited to").

[0111] Further, if a specific number of introductions of claim recitations is intended, such intent is explicitly recited in the claim, and if there is no such recitation, such intent does not exist. For example, for purposes of illustration, the following appended claims may include the use of introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to limit any particular claim that introduces a claim recitation with the indefinite article "a" or "an" to an example that includes only one such recitation even if the same claim is introduced with an introductory phrase such as "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should be construed to mean "at least one" or "one or more"). The same holds true for the use of definite articles used to introduce claim recitations.

[0112] Further, even if a specific number of introductions of claim recitations is explicitly recited, one of ordinary skill in the art will recognize that such recitation should be construed to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers means at least two recitations, or two or more recitations). Furthermore, when conventions similar to "but not limited to, at least one of A, B, and C" or "but not limited to, one or more of A, B, and C" are used, generally, such a construction is intended to include, but not be limited to, only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together.

[0113] Furthermore, any discrete words or phrases presenting two or more alternative terms, regardless of whether in the specification, claims, or drawings, should be understood to contemplate including one of the terms, any of the terms, or both terms. For example, the phrase "A or B" should be understood to include the possibilities of "A" or "B" or "A and B". Although the present disclosure has been described herein with respect to specific exemplified examples, those skilled in the art will recognize and understand that the invention is not so limited. Rather, many additions, deletions, and modifications to the illustrated and described examples can be made without departing from the scope of the invention claimed below, together with their legal equivalents. Furthermore, features from one example can still be included within the scope of the invention contemplated by the inventor and combined with features from another example.

Claims

1. A dosage injection device, A chamber for receiving the cartridge, A drive mechanism for applying force to a plunger of a received cartridge, wherein the plunger moves within the received cartridge in response to the force applied by the drive mechanism, thereby displacing the fluid within the received cartridge toward an interface for distributing fluid; A sensor that generates a position signal indicating the plunger position, A logic circuit for calculating the target amount of insulin to deliver to the user, A drive controller for generating a control signal for the drive mechanism, wherein the control signal corresponds to the target amount of insulin calculated by the logic circuit, and A dosage injection device equipped with the following features.

2. The aforementioned drive controller is A first control signal is generated to instruct the drive mechanism to apply force to the plunger. Preferably, the drive controller generates the first control signal in at least partially in response to a user action in the dose injection device. More preferably, the dosage injection device includes a user interface for receiving user actions. The dosage injection device according to claim 1.

3. The aforementioned drive controller is A second control signal is generated to instruct the drive mechanism to stop applying force to the plunger. Preferably, the drive controller generates the second control signal in at least part of the position signal indicating the plunger position, More preferably, the drive controller detects that the position of the plunger, indicated by the position signal indicating the plunger position, is a predetermined plunger position related to the target amount of insulin. More preferably, the drive controller determines a plunger position that represents an amount of insulin delivered that is substantially equal to the target amount of insulin calculated by the logic circuit. The dosage injection device according to claim 1.

4. It has a user interface for receiving meal announcements, and / or, a user interface for notifying the user that it is time to administer the dose, and / or, comprising memory for storing one or more of the following: treatment parameters, predetermined dosages, blood analyzer level data, or meal announcement data. The dosage injection device according to claim 1.

5. The logic circuit, at least in part, in response to the detection of the first condition, requests the calculated target amount of insulin. The dosage injection device according to claim 1.

6. The first administration condition includes having one or more of the following values ​​from the dose injection device: the most recent blood analyte level, the time since the last dose, the blood analyte level from the most recent dose to the last dose, and the therapeutic setting value. The dosage injection device according to claim 5.

7. The logic circuit, at least in part, in response to the detection of the threshold number of the second administration condition, requests the calculated target amount of insulin. Preferably, the second administration condition includes having a trend value for blood analyzer levels. The dosage injection device according to claim 5.

8. A detector for detecting direct physical contact between the needle housing and the user's body, A lockout circuit for alternately enabling or disabling the drive mechanism, at least in part, in response to the output of the detector, Equipped with, Preferably, the signal sensed by the detector changes in a generally predictable manner in response to a change in the capacitance of the needle housing. The dosage injection device according to claim 1.

9. It includes communication equipment for wirelessly interfacing with glucose monitoring and treatment management applications running on a mobile device, The logic circuit calculates the target amount of insulin to be delivered to the user, at least partially based on the analyte data and therapeutic parameters received via the communication device. The dosage injection device according to claim 1.

10. It includes communication equipment for wirelessly interfacing with a treatment management application running on a mobile device, The amount of insulin delivered or the target amount of insulin, or both, are accessible to the user only through the treatment management application. and / or comprising communication equipment for wirelessly interfacing with a treatment management application running on a mobile device, The amount of insulin delivered or the target amount of insulin, or both, are not accessible to the user via the dose injection device. and / or comprising a first interface for communicating with components of the dose injection device, and a second interface for communicating with a device or application located away from the dose injection device, The amount of insulin delivered or the target amount of insulin, or both, are available only through the second interface. The dosage injection device according to claim 1.

11. Memory to remember the time since the last dose, A lockout circuit for alternately enabling or disabling the drive mechanism, at least in part, depending on the value of the time since the last dose. Equipped with, Preferably, the lockout circuit disables the drive mechanism at least in part in response to detecting that the value of the time since the last dose is outside a predetermined range for administration. and / or preferably, the lockout circuit enables the drive mechanism at least in part to detect that the value of the time since the last dose is within a predetermined range to be administered. The dosage injection device according to claim 1.

12. A lockout circuit for alternately enabling or disabling the aforementioned drive mechanism, An interface for alternately indicating that the drive mechanism is disabled or enabled. Equipped with, The dosage injection device according to claim 1.

13. A drug treatment management system, Analytical sensor and, Therapeutic applications and A dosage injection device, Based at least partially on the treatment parameters received from the treatment application and the blood analyte values ​​received from the analyte sensor, the system calculates a target amount of insulin to be delivered to the user's body. The system provides a notification that the dosage preparation is complete, relating to the calculated target amount of insulin. A dose injector that delivers an insulin dose corresponding to the calculated target amount of insulin, at least in part, in response to receiving confirmation of administration. A drug treatment management system equipped with the following features.

14. The aforementioned dosage preparation completion notification includes a flashing LED or a flashing icon. and / or, the dose injector delivers the dose of insulin, at least in part in response to detection of receipt of the dose confirmation, while providing a dose ready notification relating to the calculated target amount of insulin. and / or, the analyte sensor includes a continuous glucose monitor (CGM), a flash glucose monitor (FGM), or a blood glucose meter (BGM), and / or, the analyte sensor communicates analyte data via a short-range wireless communication signal, and / or, the treatment application includes a mobile application, A drug treatment management system according to claim 13.

15. Calculating the target amount of insulin to deliver to the user, To provide a notification that the dosage preparation is complete, relating to the calculated target amount of insulin. To receive confirmation of administration in response to the notification that the dosage preparation is complete, In response to receiving the aforementioned confirmation of administration, at least in part, to request the delivery of the aforementioned target amount of insulin. Methods that include...

16. The aforementioned notification of completion of dosage preparation does not disclose the target amount of insulin to be delivered. and / or, the notification of completion of dosage preparation does not disclose the amount of insulin to be delivered. The method according to claim 15.

17. A durable insulin injection device, A chamber for receiving a pre-filled insulin cartridge, A drive mechanism for applying force to a plunger of a received, filled insulin cartridge, wherein the plunger is positioned to move within the received cartridge in response to the force applied by the drive mechanism, thereby pushing the fluid within the received cartridge toward an interface for distributing fluid; A logic circuit that receives user analysis data and calculates the target amount of insulin to deliver to the user, A dosage preparation confirmation actuator, which the user activates to deliver insulin to the user, A durable insulin injection device comprising, wherein the durable insulin injection device does not provide the user with an indication of the calculated target amount of insulin against a non-zero calculated target amount of insulin.

18. Includes notification that the dosage is ready. and / or the dosage preparation completion notification includes a flashing light-emitting diode (LED) or a flashing icon, and / or comprising a skin detector, wherein the dosage ready notification uses the skin detector to determine whether the durable insulin injection device is configured to allow injection by the user. A durable insulin injection device according to claim 17.

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