Therapeutic devices, methods, and systems including a piston detector

Abstract

A pen cover for a medication delivery pen includes a piston detector mechanism. The piston detector mechanism includes at least one inner housing having a first open end through which the medication delivery pen can be inserted, a second end opposite the first end, a sidewall defined by an outer surface and an opposite inner surface, and a passage extending from the outer surface to the inner surface. The sidewall extends between the first end and the second end thereby defining a pen receiving chamber therebetween. The piston detector mechanism further includes at least one switch and a translatable shaft at least partially disposed in the passage. The translatable shaft includes a body extending at least from a pen engaging portion in the pen receiving chamber to a switch engaging portion in the pen receiving chamber. The translatable shaft is oriented to travel from a first position to at least a second position to actuate the at least one switch during capping of a medication delivery pen into the inner housing.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to devices, methods, and systems including a piston detector. In particular embodiments, the piston detector can be located within a cap of a dose administration device, such as a drug delivery pen. The devices, methods, and systems provided herein can collect time data regarding removal and / or replacement of the cap from the dose administration device, which can then be used to determine therapy settings and / or therapy recommendations. BACKGROUND

[0002] Diabetes is a chronic metabolic disorder in which the body's inability to properly absorb sugar is caused by insufficient insulin secretion. This insufficient insulin secretion leads to hyperglycemia, i.e., the presence of excess glucose in the blood plasma. Long-term hyperglycemia can lead to a variety of serious symptoms and life-threatening long-term complications, such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage with its attendant risk of amputation. The typical method of treating diabetes is blood glucose self-monitoring and insulin self-administration. However, the "correct" dose of insulin varies with the glucose content in the blood. An insufficient dose of insulin can lead to hyperglycemia, while an excess dose of insulin can lead to hypoglycemia. Hypoglycemia can lead to clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death. Thus, a PWD faces a considerable cognitive burden in determining whether the insulin dose is appropriate.

[0003] Collecting therapy data for PWDs can be used to improve therapy decisions, and thus reliable and robust data collection tools are desirable. SUMMARY

[0004] In one embodiment, a cap for a drug delivery pen includes a piston detector mechanism. The piston detector mechanism includes at least one inner housing having a first open end through which the drug delivery pen can be inserted, a second end opposite the first end, a sidewall defined by an outer surface and an opposite inner surface, and a passageway extending from the outer surface to the inner surface. The sidewall extends between the first end and the second end, thereby defining a pen-receiving chamber therebetween. The piston detector mechanism further includes at least one switch and a translatable shaft at least partially disposed in the passageway. The translatable shaft includes a body extending at least from a pen-engaging portion in the pen-receiving chamber to a switch-engaging portion in the pen-receiving chamber. The translatable shaft is oriented to travel from a first position to at least a second position to actuate the at least one switch during capping of the drug delivery pen into the inner housing.

[0005] In one embodiment, a method for capping a medication delivery pen includes: capping a medication delivery pen into the cap sleeve containing the plunger detector mechanism; during capping, communicating movement of the medication delivery pen to the translatable shaft of the plunger detector mechanism such that the switch engagement portion interacts with the switch to cause toggling of the switch.

[0006] In one embodiment, a system includes: the cap sleeve containing the plunger detector mechanism; an analyte sensor system in communication with the cap sleeve, wherein the analyte sensor includes: a blood glucose meter, a dynamic glucose monitor, or a continuous glucose monitor and a mobile computing device capable of wireless communication with the cap sleeve.

[0007] Additional advantages of embodiments will be set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of embodiments. The advantages of the application will be realized and attained by means of the elements particularly pointed out in the appended claims.

[0008] The above discussion and the following detailed description are both illustrative and explanatory only and should not be considered limiting in any regard. BRIEF DESCRIPTION OF DRAWINGS

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description, serve to explain the principles of the patent application disclosure.

[0010] Figure 1A A diabetes management system is described that can include embodiments described herein including a cap sleeve, an insulin injection pen, a glucose sensor, and a mobile device.

[0011] Figure 1B A PWD is shown using a glucose sensor on an arm to detect the PWD's blood glucose level, and a user is shown using a cap sleeve that has been affixed to a fast-acting insulin pen, including embodiments of a cap sleeve as described herein, to obtain data from the glucose sensor.

[0012] Figures 1C to 1E A cap sleeve of an embodiment is shown displaying information such as time, suggested dose, and meal suggestions on the cap sleeve display, for example, when capping or uncapping.

[0013] Figure 2 An example communication architecture for a system including a cap sleeve of the present application is shown. Figure 1A An example communication architecture for a system including a cap sleeve of the present application is shown.

[0014] Figures 3A to 3D A perspective view of a cap sleeve including a plunger detector mechanism of the present application, Figure 3C A top side view (including a close-up view of a plunger detector), Figure 3DThis is a bottom side view (a close-up of the piston detector).

[0015] Figure 3E for Figures 3A to 3D The image shows a cross-sectional view of the inner shell of the cover.

[0016] Figures 4A to 4B This is a cross-sectional view of the piston detector mechanism in action when the drug delivery pen with the needle is inserted into the cover of the embodiment.

[0017] Figures 5A to 5B This is a cross-sectional view of the piston detector mechanism in action when a drug delivery pen without a needle is inserted into the cover of the embodiment.

[0018] Figures 6A to 6C This is a perspective view showing varying degrees of detail of a cover containing at least two Near Field Communication (NFC) antennas in an embodiment.

[0019] Figure 6D For use Figures 6A to 6C A perspective view of the dual NFC antennas in the cover.

[0020] Figures 7A to 7B This demonstrates how PWD uses a glucose sensor on the right arm. Figure 7A ) or his left arm ( Figure 7B This allows for the detection of PWD blood glucose levels and how users can use it. Figures 6A to 6C The cap is fixed to the rapid-acting insulin pen to acquire data from the glucose sensor.

[0021] It is worth noting that, in order to better understand the relevant technologies in this invention, the drawings in this disclosure have been simplified and the drawings in this disclosure do not strictly adhere to structural accuracy, detail and proportion. Detailed Implementation

[0022] Embodiments of this disclosure are described in detail with reference to the accompanying drawings, some of which are shown in the drawings. The same drawing numbers will be used to refer to the same or corresponding parts wherever possible.

[0023] Notwithstanding that the numerical ranges and parameters setting forth the broadest scope of applicability of the embodiments are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, can contain certain errors associated with the standard deviation found in their respective testing measurements. Further, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of "less than 10" can include any and all subranges between (and including) the minimum value of zero and the maximum value of 10, that is, any and all subranges having a minimum value of equal to or greater than zero, and a maximum value of equal to or less than 10, e.g., 1 to 5. In some cases, numerical values as set forth can take on negative values. In this case, ranges disclosed as "less than 10" can have lower bounds of negative values, e.g. -1, -2, -3, -10, -20, -30, etc.

[0024] The following examples are described with reference to the accompanying drawings for illustrative purposes only. One skilled in the art will appreciate that the following specific description is descriptive, not limiting, of exemplary embodiments and that modifications can be made to the parameters set forth herein without departing from the scope of the embodiments of the present disclosure. The specification and examples do not restrict the scope of the embodiments of the present disclosure, which are merely examples. Different embodiments are not mutually exclusive, and some embodiments can be combined with one or more other embodiments to form new embodiments. It should be understood that the structures shown in the drawings have been simplified and can include other features, while the structures shown in the drawings can be removed or modified.

[0025] The cap sleeve in the present disclosure can use any appropriate technology to obtain the pen capping information. In some cases, the cap sleeve in the present disclosure can have a piston detector mechanism that includes a piston that extends into the injection pen receiving inner housing of the cap sleeve and contacts the injection pen when the injection pen is inserted into the cap sleeve, and presses against a switch when the cap sleeve is secured to the injection pen.

[0026] In exemplary embodiments of the therapy management system provided in the present disclosure, the following Figure 1A A diabetes management system 10 is shown, which includes insulin injection pens 110 and 120, a glucose sensor 130, and a mobile device 140. The mobile device can be any suitable computer application device, such as a smartphone or a tablet computer. The mobile device can store and execute a mobile application program for displaying relevant therapy information wirelessly received from other components of the diabetes management system.

[0027] As shown, each insulin injection pen 110 and 120 includes a respective cap 112 and 122, each of which includes a button and a display. In the embodiment shown in FIG. 1, the insulin pens can be mechanical insulin pens available on the market containing any suitable insulin, including long-acting insulin and rapid-acting insulin (sometimes referred to as fast-acting insulin or ultrafast-acting insulin). Among the rapid-acting insulins that can be used are Humalog® TM , Novolog® TM , Apidra® TM , and Fiasp® TM . Among the long-acting insulins that can be used are Lantus® TM , Levemir® TM , Toujeo® TM , and Tresiba® TM . As shown, insulin injection pen 110 is representative of a long-acting insulin pen, while insulin injection pen 120 is representative of a rapid-acting insulin pen.

[0028] As shown, caps 112 and 122 can have unique colors, shapes, or other physical or digital differentiating features to assist a person with diabetes (PWD) in distinguishing between the long-acting cap 112 and the rapid-acting cap 122. The caps can be in wireless communication with the mobile device 140 so that data from the caps can be received and displayed by the mobile application.

[0029] The glucose sensor 130 can be any suitable glucose sensor, such as a blood glucose meter (BGM) and a dynamic glucose sensor, or a continuous glucose sensor (CGM). In some cases, the glucose sensor can wirelessly transmit data when read by a reader device (e.g., using NFC communication). In some cases, the glucose sensor 130 can use any suitable communication standard (e.g., BLE) to wirelessly transmit data at predetermined intervals (e.g., using radio frequencies). In some cases, the glucose sensor 130 can use multiple communication technologies to transmit glucose data. In some cases, the mobile device 140 and / or one or more of the insulin injection pens or caps can include an NFC reader. The NFC reader can be adapted to obtain blood glucose data when within an interrogation distance of the glucose sensor. In some cases, the mobile device 140 and / or one or more of the insulin injection pens 110, 120 or caps 112, 122 can wirelessly receive blood glucose data broadcast from the glucose sensor 130 at predetermined time intervals (e.g., every minute, every 5 minutes, etc.).

[0030] In use of example diabetes management system 10, the PWD (or their caregiver) can be responsible for determining when to inject insulin and how much insulin to inject, but system 10 can assist the PWD (or caregiver) in determining the appropriate insulin dosage according to current data from the glucose sensor, according to stored treatment parameters, and / or according to relevant data for the insulin injection. In some cases, the cap can provide data regarding when the last insulin injection was performed according to data reflected by the piston detector mechanism in the present disclosure. For example, caps 112 and 122 can detect, through the piston detector mechanism in the present disclosure, the time at which each cap is reapplied to its insulin injection pen, which can be considered the time of injection. In some cases, caps 112 and 122 can note the amount of insulin remaining in the insulin injection pen and can determine the amount of insulin injected each time. Reference can be made to commonly-pending U.S. Patent Applications Nos. 62 / 599,963 and 62 / 648,064, both incorporated by reference herein, as well as published patents and applications numbers WO 2017 / 009724 Al; US 8,817,258 Bl; and EP 2987 518 Bl, all incorporated by reference herein.

[0031] Figure 1B An example is shown of how PWD 20 can apply glucose sensor 130 to their arm, thereby detecting the PWD’s blood glucose level, and how the user can use cap 122 fastened to rapid-acting insulin pen 120 to read data from glucose sensor 130. Before and / or after the user slides cap 122 in FIG. 1 Figure 1B In some cases, the relevant treatment information can include information about one or more insulin injections recently administered, glucose data, and / or a suggestion of one or more insulin dosages. For example, cap 122 can display the time of the most recent insulin administration before or after the slide. In some cases, before cap 122 is slid adjacent to glucose sensor 130, cap 122 can display an insulin dosage suggestion for a meal that does not include a correction component. In some cases, after cap 122 is slid adjacent to glucose sensor 130, cap 122 can display a correction insulin dosage suggestion or an insulin dosage suggestion for a meal that includes a correction component.

[0032] For example, Figure 1CThe cap 122 is shown with a display 124 that can show the most recent medication or "last medication" time 125. The time 125 can assist the user in recalling whether they have taken medication for a recent meal and / or help the user avoid accidentally double dosing. In some cases, such as when the cap is able to detect the medication dose given, the display can additionally show the last medication dose value. In some cases, the last medication time can be represented as a clock showing how much time has elapsed since the last medication. In some cases, the display can show the most recently measured blood glucose level and the time of the measurement. In some cases, the display can be an e-ink display. In some cases, the display can include identifying information (e.g., the user's name, such as the identification "Sarah's pen") and / or information about the type of insulin pen (e.g., the brand of insulin).

[0033] Figure 1D The cap 122 is shown with blood glucose data 129 presented. The blood glucose data 129 can include the current blood glucose level and a blood glucose level trend arrow that can be received from the glucose sensor 130 after the cap is capped as shown in Figure 1B Figure 1D Also included are correction dose suggestions 127d and corresponding correction dose icons 126d.

[0034] Figure 1E The cap 122 is shown with meal dose suggestions 127a-127c that can be given for different sized meals represented by meal icons 126a-126c. Additionally or alternatively, the user can personalize the meal icons 126a-126c to represent different types of meals (e.g., B, L, D labels to indicate breakfast, lunch, dinner, or pictures of meals such as a salad icon, a sandwich icon, and a pasta icon). For example, in use, upon seeing Figure 1D ​After the display, the user can press button 123 to obtain a meal bolus recommendation. In some cases, the meal bolus recommendation can be given based on the setting values set by the healthcare professional, PWD, or caregiver during setup using the mobile application, or updated values of meal bolus updated by the healthcare professional, PWD, or caregiver. In some cases, the meal bolus recommendation can be given according to the user's personal bolus parameters that are automatically updated by the system using any suitable algorithm. In some cases, when the user recently (e.g., within the last 5, 10, 15, 20, or 30 minutes) read the blood glucose level, the meal bolus recommendations 127a-c can include both meal bolus and correction bolus at the same time. In some cases, if the cap 122 has recognized other recent medication times (e.g., by detecting capping action of the cap within the last 3 hours, last 4 hours, or last 5 hours) without knowing the medication bolus, the cap can refuse to add the correction component to prevent accidental repeated administration of the correction medication. In some cases, the meal bolus icons 126a-c can indicate whether the meal bolus recommendation includes a correction component. In some cases, additional icons or display data can be used to indicate whether the meal bolus recommendation includes a correction bolus recommendation and / or how much of the correction bolus is recommended. In some cases, by pressing button 123, the user can see the display showing the current blood glucose value, trend information (e.g., trend arrow), and the recommended correction bolus. In some cases, if there has been a recent medication of insulin (e.g., within the last 1, 2, 3, or 4 hours), a warning alert can appear near or above the correction bolus recommendation to prevent accidental repeated use of insulin. In some cases, a notification icon 128 can be presented on the cap 122 to indicate to the user that the user can obtain more detailed recommendations, tips, warnings, or alerts in the mobile application on the mobile device 140.

[0035] The caps 112 and 122 and other methods, devices, and systems provided in the present disclosure can simply and easily provide users with therapy-related information and / or therapy recommendations, while and / or collect and use pen capping information.

[0036] The cover sleeves 112 and 122 can be configured to wirelessly communicate with one or more glucose sensors and / or one or more mobile computing devices. In some cases, the cover sleeves provided in the present disclosure can be adapted to wirelessly receive glucose data from a glucose sensor and wirelessly transmit glucose data from the glucose sensor to a mobile computing device. In some cases, the cover sleeves provided in the present disclosure can receive glucose data from a glucose sensor using a first wireless communication technology and transmit glucose data to a mobile computing device using a second wireless communication technology. In some cases, the first wireless communication technology can have a closer intended communication range than the second communication technology. In some cases, a user must use the first communication technology to obtain glucose data from a glucose sensor while transmission of the glucose data is automatically made via the second communication technology. In some cases, the cover sleeve communicates with a glucose sensor 130 using NFC and the user must bring the cover sleeve in close proximity to a glucose sensor 130 that has been subcutaneously implanted in a human to obtain glucose data. In some cases, the cover sleeve can communicate with a mobile computing device using BLE. The BLE communication can be triggered at intervals and / or automatically after the cover sleeve receives glucose data from a glucose sensor. In some cases, the mobile device 140 can also receive glucose data from a glucose sensor using any suitable technology and can transmit glucose data from the mobile computing device 140 to the cover sleeve 112 or 122. In some cases, glucose data in a single transmission from a glucose sensor to a cover sleeve can include data that enables the cover sleeve to determine at least two estimated glucose values (EGVs) over a period of at least 30 minutes. In some cases, a single transmission of data can include at least 1 hour of glucose data, at least 2 hours of glucose data, at least 4 hours of glucose data, at least 6 hours of glucose data, or at least 8 hours of glucose data.

[0037] The cover sleeves 112 and 114 can include one or more processors and memory for controlling wireless communications, controlling user interfaces, and / or determining therapy recommendations. In some cases, the cover sleeves provided in the present disclosure can include a processor and associated memory that can determine EGV values from sensor raw data with an algorithm. In some cases, the glucose sensor can transmit the EGV values. In some cases, the cover sleeves provided in the present disclosure can include memory to store user personal dosing parameters (e.g., daily dose recommendations for long-acting insulin or total daily basal dose (TDBD), insulin sensitivity factor (ISF), carbohydrate-insulin ratio (CR), total daily insulin dose (TDD), target glucose value, etc.). In some cases, the user personal dosing parameters can be time- or day-dependent parameters, such as CR and ISF values that vary with time of day. In some cases, the cover sleeves provided in the present disclosure can have memory to store bolus insulin dose recommendations for different meals or for different meal categories. In some cases, the user personal dosing parameters and / or different dose recommendations for different meals can be updated via a mobile computing device in wireless communication with the cover sleeve. For example, an algorithm in the mobile computing device or in the cloud can update these parameters or dose recommendations. In some cases, the parameters or dose recommendations can be updated by a health care professional or manually by the PWD or caregiver. In some cases, the cover sleeve can include an algorithm within the cover sleeve memory that, when executed by the processor, updates the user personal dosing parameters or dose recommendations.

[0038] In some cases, the cover sleeves provided in the present disclosure can display or otherwise inform the user of current blood glucose content and / or blood glucose trend data (e.g., rate of change) based on glucose data received from a continuous glucose monitor, flash glucose monitor, blood glucose meter, or any other suitable glucose sensor. The cover sleeves provided in the present disclosure can also provide insulin dose recommendations based on one or more of blood glucose data, user personal dosing parameters, bolus recommendations set by the user or health care professional, time of day, meal data or meal category, or any other suitable inputs.

[0039] Pen cap-on and cap-off information (i.e., time information of when a cap is secured to and / or released from an injection pen) can include information about the current cap-on period (e.g., the time elapsed since the last cap-on), time interval information about one or more cap-offs, and time information of each cap-off and each cap-on (e.g., the specific time of day that a cap-off occurs or the time elapsed since the last cap-off). In some cases, the cap can display pen cap-on and cap-off information to the user. In some cases, pen cap-on and cap-off information can be announced to the user by a speaker in the cap. For example, in some cases, the cap can provide a timer clock that times the total time elapsed since the last time the cap was secured to the injection pen. In some cases, the cap can wirelessly communicate pen cap-on and cap-off information to a mobile device 140 (e.g., a smartphone, tablet, etc. running a mobile application).

[0040] Pen cap-on and cap-off information can be used to adjust the user experience. In some cases, the cap can adjust the presentation of therapy-related information and / or recommendations to the user based on the pen cap-on and cap-off information. For example, in some cases, the cap can recommend a correction bolus dose that is capable of correcting a high blood glucose level based on data from a glucose sensor, but the cap can only present this correction bolus recommendation when the pen cap-on and cap-off interval is greater than a threshold period of time (e.g., at least 3 hours, at least 4 hours, or at least 5 hours). In some cases, the cap can provide notifications, warnings, or alerts to the user based on the pen cap-on and cap-off information. For example, if the cap is removed from the injection pen within a threshold period of time from the last cap-on and cap-off time (e.g., within 30 minutes or 1 hour), the cap can provide a visual, audible, or vibratory notification to alert the user that the injection pen can have recently been used by the user to inject insulin. In some cases, the cap can wirelessly communicate with a mobile computing device (e.g., a smartphone, tablet) and the mobile computing device can notify or display one or more notifications, warnings, or alerts generated based on the pen cap-on and cap-off information.

[0041] Storing, displaying, analyzing pen cap-on and cap-off information together with glucose data can determine user behavior, such as whether the user is using insulin correctly for meals and / or to correct high blood glucose levels. In some cases, pen cap-on and cap-off information can be presented on a user's glucose data graph and presented to the user and / or a health care professional at the same time. In some cases, evaluating blood glucose data over a period of time after each cap-on can determine whether the user is using insulin correctly at cap-on and whether the user is under- or over-dosing.

[0042] Figure 2 An exemplary communication architecture for a system for Figure 1A is presented, and an exemplary system for Figure 1APossible communication links between components of the system. The various components can be connected to each other via wireless control, NFC, or BLE communication protocols. Each component in the system displays, transmits, and receives information depending on the system workflow that is being conducted at a particular point in time. As shown, the glucose sensor 130 can communicate via NFC with the fast-acting cap 122, communication link 231, and / or with the mobile device 140, communication link 232. In some cases, the long-acting cap 122 can communicate with the glucose sensor 130 via NFC communication. In some cases, because only fast-acting insulin is used as a correction or meal dose, the long-acting cap 122 is not directly in communication with the glucose sensor via NFC to prevent user confusion. In some cases, the glucose sensor 130 can additionally communicate with the mobile device via a radio that transmits blood glucose values at predetermined intervals. Both caps 112 and 122 can communicate with the mobile device 140 via BLE communication. Blood glucose data, programmed therapy parameters (e.g., daily dose of long-acting insulin, doses for different meal sizes (which can vary depending on the time of day), insulin sensitivity factor, carbohydrate-insulin ratio, etc.), pen plus cap data (with or without dose data detected by the cap), can be communicated between the mobile device 140 and each cap 112 and 122, and system data can be communicated to a network service 250 (which can be any remote server) via WiFi or cellular connection 241. In some cases, each cap can be configured with the processor and memory included to perform an algorithm to determine a dose recommendation. In some cases, the mobile device can implement a therapy recommendation or implement a therapy parameter update algorithm to recommend changes to and / or automatically update programmed therapy parameters. In some cases, the network service 250 can implement an algorithm to recommend changes and / or automatically update programmed therapy parameters.

[0043] In some cases, initial therapy parameters can be programmed into a mobile application on the mobile device 140 and transmitted to the caps via the BLE communication links 211 and 221. In some cases, the cap 122 can provide correction dose and meal dose recommendations using therapy parameters received from the mobile application. In some cases, the therapy parameters can include meal doses for different or different sized meals (e.g., small, medium, and large meals; or breakfast, lunch, and dinner; or salad, sandwich, and pasta). In some cases, the therapy parameters can include therapy parameters for correcting blood glucose values, such as an insulin sensitivity factor. In some cases, the cap 112 can receive a therapy parameter that specifies a daily dose of long-acting insulin. In some cases, the cap 112 can receive a recommended time of use of long-acting insulin from the mobile device mobile application 140 (e.g., 9 PM every day, 8 AM every day, 8 AM and 8 PM twice a day, etc.).

[0044] The cap can also be configured to understand the dosage recommendations a user may be following. For example, as described in U.S. Patent Application No. 15 / 717,805, the cap (regardless of whether it has a dose-capturing feature) may contain a classification of meal notifications (e.g., S, M, L), and data in each notification may indicate whether the user may have used an appropriate insulin dose for an S, M, or L meal. U.S. Patent Application No. 15 / 717,805 is incorporated herein by reference. In some situations, multiple presses of a button on the cap 122 may display dosage recommendations for subsequent S, M, and L meals, and the methods and systems provided in this disclosure may assume that the user has used insulin according to a previously displayed dosage recommendation. In some situations, information on the residual insulin level in the pen at different time intervals (once daily, every few days, once a week) added to a mobile application may indicate whether the user is generally following treatment recommendations or whether the user is ignoring the treatment recommendations. In some situations, the methods and systems provided in this disclosure can determine the likelihood of a user following dosage recommendations or rate the user by analyzing glucose data, pen capping information, data on the remaining insulin levels in one or more pens, and / or answers to questions provided in a mobile application. The methods and systems provided in this disclosure can use this likelihood or rating to determine whether dosage recommendations need to be adjusted or to provide guidance to the user.

[0045] The methods and systems provided in this disclosure may also be included in a mobile application running on a mobile device (e.g., a smartphone or tablet computer) that wirelessly communicates (e.g., via BLE) with one or more covers in this disclosure. In some cases, glucose data may be transmitted from the glucose sensor via the cover and / or directly from the glucose sensor. In some cases, the mobile application may have a user interface to graphically display the glucose data. In some cases, a graph displaying glucose data over time may include an indicator conveying pen-on-cap-off information.

[0046] In order to collect the cap-adding and / or cap-removing information described above, a mechanism capable of detecting cap-adding and / or cap-removing may be placed inside the cap sleeve, for example, inside cap sleeve 112 and / or cap sleeve 122. Figures 3A to 3D A cover 312 is shown for use with a dosing device, such as a drug delivery pen (not shown). Figure 3A In the middle, the cover 312 includes a housing 301, and several components can be accommodated within the housing 301, such as Figure 3BAs shown. The housing 301 may include a first portion 301a and a second portion 301b joined together at a seam 302 to define a first opening 304 and a second opening 306. The first portion 301a and the second portion 301b may be joined by friction, snap-fit, welding, gluing, melting, or any other suitable adhesive method. In some embodiments, the housing 301 may have an integral spatial configuration (not shown).

[0047] For example, the internal components of display 314 and / or button 309 may be housed within housing 301. Display 314 may be an LCD, electronic paper, LED, OLED, or any other suitable display, viewable through opening 308 in housing 301. Button 309 may be a mechanically spring-loaded button, a touch-responsive button (i.e., a touchscreen and / or haptic response), accessible to the user via opening 308 or via a separate opening. Housing 301, first portion 301a, and / or second portion 301b may comprise one or more of plastic, metal, any other suitable material, combinations thereof, or any other suitable material type. Housings may have varying degrees of transparency, ranging from substantially transparent (e.g., internal components are visible through the housing) to substantially opaque (e.g., the interior is not visible through the housing). Housings may be manufactured using any suitable manufacturing process and its appropriate materials, such as machining (e.g., CNC machining, turning, etc.), additive manufacturing (e.g., 3D printing), injection molding, blow molding, casting, stamping, laser cutting, etc.

[0048] like Figure 3B As shown in the exploded view of the cover 312, the piston detector mechanism 315, along with the display and button, is housed within the housing 301. The display, button, and piston detector mechanism 315 can be attached together, for example, to form a common unit. The common unit may have a modular design that allows each component to be individually attached to or detached from other components. For example, the display 314, button 309, and piston detector mechanism 315 may be mounted on, for example, a common support base (not visible), and may be connected to a circuit board (not visible) along with a memory and processor that communicates with the memory and is configured to execute instructions stored in the memory; and an onboard power supply (not shown), such as a rechargeable battery.

[0049] The piston-type detector mechanism 315 includes: an inner shell 350 designed to receive an insulin delivery pen; a piston assembly 360 that interacts with the insulin delivery pen when it is fastened to the cap (capping action) or removed from the cap (uncapping action); and electronic circuitry 370 that provides an electrical path for the piston assembly to transmit the capping or uncapping action to a circuit board and ultimately to a processor. For example, when the piston assembly 360 interacts with the delivery pen during capping or uncapping, the electronic circuitry 370 transmits a signal via an opening 303.

[0050] like Figures 3C to 3E As shown in 4A to 4B and 5A to 5B and further described below, the inner shell 350 includes a pen body fastening portion 351, a needle fastening portion 353, and an opening 303 through which the pen can be inserted into a pen receiving chamber (not visible) and a channel (not visible) to allow the piston assembly 360 to enter the cover.

[0051] like Figures 3C to 3E As shown in the enlarged view, the inner housing 350 of the piston detector mechanism 315 may further include a second end 356 opposite to the first end 303, and a sidewall 358 defined by an outer surface 352 and an opposite inner surface 354. The sidewall 358 extends between the first end 303 and the second end 356 to define a pen receiving chamber 351'. The second end 356 may further define a needle receiving chamber 353'. A channel 355 includes a first opening 355' adjacent to the chamber 351' and an opposite second opening 355'. The channel 355 allows a translational shaft 361 disposed in the inner housing to slidably pass through at least a portion of the inner housing 350.

[0052] For example, electronic circuit 370 includes at least one switch 371 that is usable by piston assembly 360, for instance, when drug delivery pen 380 is inserted through opening 303. The at least one switch may be a microswitch with a toggle arm 371'. In some embodiments, the at least one switch may be a "normally open" switch, meaning that the at least one switch is in an open-circuit configuration by default when there is no external influence to toggle the switch within the circuit. In some embodiments, the at least one switch may be a "normally closed" switch, meaning that it is in an open-circuit configuration by default when there is no external influence to toggle the switch within the circuit.

[0053] The piston assembly 360 includes a translational shaft 361 that can be at least partially disposed in a channel 355. The translational shaft 361 may include a body extending at least from the pen engagement portion 361' to its switch engagement portion 361". As further described below, and Figures 4A to 4Band as shown in more detail in 5A to 5B, the translatable shaft 361 is oriented to travel from a first position to at least a second position during capping of the drug delivery pen with the cap sleeve to actuate at least one switch. After removal of the drug delivery pen, the translatable shaft 361 can be configured to return to the first position. For example, the piston return 363 can be configured to automatically return the translatable shaft 361 to the first position.

[0054] Figures 4A to 4B A cross-sectional view of the operation of the piston detector mechanism is shown when a drug delivery pen with a needle is inserted into the cap sleeve of the embodiment. As described above, the translatable shaft 361 can be slidably disposed in the channel 355 via the first opening 355' and the second opening 355". As shown, the piston return 363 can comprise a spring that is concentrically disposed on the translatable shaft between the first opening 355" and the switch engagement portion 361'. Figures 4A to 4B and Figures 5A to 5B As shown, during capping or decapping of the drug delivery pen with the cap sleeve, the translatable shaft is oriented to travel from a first position to at least a second position. As shown, the piston return 363 can comprise a spring that is concentrically disposed on the translatable shaft between the first opening 355" and the switch engagement portion 361'. To prevent the translatable shaft 361 from sliding completely through the channel 355 and into the pen receiving chamber 351', it can comprise a limiter 364, such as a collar assembly or an integrated shoulder portion having a wider diameter than the second opening 355" of the channel 355.

[0055] Further, the outer housing 301 cooperates with the inner housing 350 of the piston detector mechanism 315 to define at least an inner chamber to prevent ingress of moisture or any other foreign matter that can harm some components of the piston detector mechanism, such as the circuit 370 and at least one switch 371', which can be positioned individually or together, for example, in the inner chamber between the inner housing 350 and the outer housing 301. The outer housing 301 can cooperate with the inner housing 350 to prevent liquid ingress into the inner chamber to thereby form a water-resistant inner chamber, or to form a chamber having an IPX5 or better (IEC Standard 60529) water resistance rating. To prevent ingress of moisture or any other foreign matter from the pen receiving chamber 351' into the inner chamber, a seal 365 can be disposed at the second opening 355". The seal can be a boot seal that can be compressed between the first opening 365' and the pen 380. The seal can also or further comprise a coating, such as a sealant and / or lubricant composition applied to the surface of the body of the piston.

[0056] In embodiments, the switch 371 can detect one, two, three, or different configurations. For example, a toggle switch 371'can toggle into two different positions (e.g., a first position and a second position) or three different positions (a first, second, and third). For example, the toggle switch 371'can be in a first "off' toggle position where the translatable shaft is in its original, undisturbed position because the boot and pen are not secured together; and the toggle switch 371'can be in a second toggle position where the piston has traveled a first distance because the boot is secured to the injection pen without a needle. The toggle switch 371'can additionally be in a third toggle position where the piston has traveled a second distance because the boot is secured to the injection pen with a needle, which second distance can be the first or second distance depending on the configuration of the pen.

[0057] The provision of various contacts for a foreign object, such as a pen, inserted into the boot can depend on the shape, size, and orientation of the piston. For example, in some cases, the piston can include a first section having a first outer diameter and a second section having a second outer diameter such that the piston moves the switch to a third toggle configuration with a secured needle, but to a second configuration without a secured needle. In another example, the piston can have a diameter that gradually decreases along the length of the piston body from a first position to a second position such that the switch can determine the relative depth of the pen inserted into the boot, thereby further determining whether the inserted pen has a needle. The detected data of whether the inserted pen has a needle can be used to determine whether the user likely changes the needle after each injection or uses the same needle for multiple injections. In some cases, the detected data of whether the inserted pen has a needle can be used to determine the number of needle refills for the user and / or provide instructions to the user regarding proper needle replacement. In embodiments, the switch can include a proximity sensor to detect the distance traveled by the translatable shaft, thereby analyzing the distance a drug delivery pen has been inserted into the inner housing of the boot or whether the drug delivery pen has been fully inserted (i.e., secured) into the inner housing of the boot.

[0058] In embodiments, the channel for the translatable shaft is configured parallel to the long axis of the inner housing. In embodiments, the channel 355 for the translatable shaft 361 is configured parallel offset from the long axis of the inner housing. In embodiments, the translatable shaft is disposed parallel offset from the central axis (b-b') of the inner housing 350 and travels in a direction (a-a') parallel to the central axis (b-b') of the inner housing 350. Thus, the presence or absence of a needle on the pen has no effect on detecting the capping or uncapping of the pen. This is because the engagement location 383 between the pen and the piston detection mechanism is at the pen body shoulder 381.

[0059] As described above and Figures 1A to 1ESimilar to the cap covers 112 and 122 shown, the cap cover 312 can be part of a system that further includes an analyte sensor system (e.g., a blood glucose meter, a dynamic glucose monitor, or a continuous glucose monitor) in communication with the cap cover, and / or a mobile computing device that can be used to configure therapy parameters including bolus recommendations for meals of different sizes, insulin sensitivity factors, carbohydrate-insulin ratios, long-acting insulin daily doses, or combinations of the above information. The cap cover can wirelessly communicate with the mobile computing device to transmit, for example, dosing time data to a remote user interface. The wireless communication can include pairing the cap cover with the analyte sensor system, setting or updating therapy parameters, and sending therapy information. The wireless communication can include sending therapy information to the cloud for analysis, updating therapy parameters, or one or more of the above combinations. The wireless communication can also include therapy information such as capping data, analyte data, or combinations of the above information.

[0060] The cap cover can include an NFC reader for reading blood glucose data of a glucose sensor when within an interrogation distance of the glucose sensor. A PWD can wave the cap cover secured to a fast-acting insulin pen to begin interrogation of a glucose sensor by applying the glucose sensor to an arm to detect the PWD's blood glucose level.

[0061] Figures 6A to 6C A perspective view of a cap cover 612 for a dosing device, such as a medication delivery pen (not shown), is shown. As shown, the cap cover 612 includes an outer housing 601, a display 614, and an inner housing 650 mated with the outer housing 601. The inner housing 650 can include a first open end 603 through which the pen can be inserted, a second end 656 opposite the first end 603, and a sidewall defined by an outer surface and an opposing inner surface, where the sidewall extends between the first end (opening 603) and the second end, thereby defining a pen-receiving chamber (not visible). A first NFC antenna 691 can be configured to receive at least one signal generated by a transcutaneous sensor. The first NFC antenna 691 can be located between the housing and a first side of the inner housing 650. Meanwhile, a second NFC antenna 693 can be configured to receive at least one signal generated by a transcutaneous sensor and located between the outer housing 601 and a second side of the inner housing 650. In one example, the inner housing 650 is disposed between the first NFC antenna 691 and the second NFC antenna 693.

[0062] The cap cover 612 for a medication delivery pen as described herein can also include a memory (not visible), a processor in communication with the memory (not visible) and configured to execute instructions stored in the memory, and an NFC reader (not visible) in communication with the processor.

[0063] The cap cover 612 for a medication delivery pen as described herein can also include a memory (not visible), a processor in communication with the memory (not visible) and configured to execute instructions stored in the memory, and an NFC reader (not visible) in communication with the processor. Figures 1A to 1ESimilar to caps 112 and 122 shown, cap 612 may be part of a system that further includes an analyte sensor system (e.g., a blood glucose meter, a dynamic glucose monitor, or a continuous glucose monitor) communicating with the cap, and / or a mobile computing device that can be used to configure treatment parameters, including a combination of information such as recommended doses for different meal sizes, insulin sensitivity factors, carbohydrate-insulin ratios, daily doses of long-acting insulin, etc. The cap may wirelessly communicate with the mobile computing device to transmit, for example, medication time data to a remote user interface. The wireless communication may include pairing the cap with the analyte sensor system, setting or updating treatment parameters, and sending treatment information. The wireless communication may also include sending treatment information to the cloud for one or more analyses, updating treatment parameters, or a combination of the above functions. The wireless communication may also include treatment information such as cap-on / cap-off data, analyte data, or a combination of the above.

[0064] like Figures 6C to 6D As shown, the antenna for the cover 612 includes a first NFC antenna 691 and a second NFC antenna 693 disposed on a common substrate and separated by a base portion 695. The substrate includes: a base portion 695, a first substrate portion on which the first NFC antenna 691 is disposed, and a second substrate portion on which the second NFC antenna 693 is disposed. The first NFC antenna 691 is separated from the base portion by a first bent or hinged portion 697. The second NFC antenna 693 is separated from the base portion by a second bent or hinged portion 699. The antenna can be connected to circuitry 670 by means of a contact 694. A reinforcement, as shown at 692, can be added to the antenna to prevent damage. The first NFC antenna 691 and the second NFC antenna 693 can be disposed on opposite sides of the display 614. For example, the first NFC antenna 691 can be disposed on a first side of the display 614, and the second antenna 693 can be disposed on an opposite second side of the display 614. The first NFC antenna 691 and the second NFC antenna 693 can be oriented substantially perpendicular to the main display surface of the display 614. For example, the first NFC antenna 691 and the second NFC antenna 693 may be oriented, respectively, to be substantially parallel to or substantially perpendicular to the display 614, such as at an angle of about 0° to about 90°, an angle of about 15° to about 85°, and even an angle of about 35° to about 65°, including an angle of about 45°, relative to the main display surface of the display 614.

[0065] It should be noted that the features of the above cap sleeve 312 can be combined with the features of the cap sleeve 612. For example, a cap sleeve for a dose administration device, such as a medication delivery pen, can contain both a piston detector mechanism for detecting insertion / removal of the pen and a dual antenna system with, for example, a first NFC antenna and a second NFC antenna. Accordingly, the inner housing 650 can contain any and all features of the inner housing 350.

[0066] Figures 7A to 7B Methods of presenting signals collected by a detection sensor, such as an analyte sensor, are presented that can detect signals as a subcutaneous sensor. In particular, the methods describe how a PWD can use a glucose sensor on their right arm Figure 7A ) or their left arm Figure 7B ) to detect the PWD's blood glucose level, and how a user can use a cap sleeve on a fast-acting insulin pen to read data from a glucose sensor on either arm. Figures 6A to 6C

[0067] The cap sleeve 612, which contains a first NFC antenna 691 and a second NFC antenna 693, is placed proximally to an analyte sensor 631. As shown in Figure 7A , in some embodiments, when the cap sleeve is placed proximally to an analyte sensor 630 on a PWD's right arm, the first antenna 691 is closer to the subcutaneous sensor than the second antenna 693. In an example, as shown in Figure 7B , in some embodiments, when the cap sleeve is placed proximally to an analyte sensor 630 on a PWD's right arm, the second NFC antenna 693 is closer to the subcutaneous sensor than the first NFC antenna 691. A NFC reader can be activated to alternate reading the first NFC antenna 691 and the second NFC antenna 693. Referring to Figures 6A to 6C , the first NFC antenna 691 and the second NFC antenna 693 can be positioned between the outer housing 601 and the inner housing 650, when the cap sleeve 612 is oriented relative to the analyte sensor 630, for example, in a first orientation (e.g., as shown in Figure 7A ), the first NFC antenna 691 receives a signal strength of at least one signal, for example, generated by the analyte sensor, with a higher signal strength than the second NFC antenna 693. And, when the cap sleeve 612 is oriented relative to the analyte sensor 630, for example, in a second orientation (e.g., as shown in Figure 7B ), the second NFC antenna 693 receives the signal strength of the at least one signal with a higher signal strength than the first NFC antenna 691.

[0068] When a user holds the cap sleeve 612 to scan a glucose sensor 630 on their right arm "R" as shown in Figure 7A , the user can hold the cap sleeve 612 to have a first orientation. Alternatively, when a user holds the cap sleeve 612 to scan a glucose sensor 630 on their left arm "L" as shown in Figure 7B ​The user can hold the cap 612 with the second orientation as the cap 612 scans the glucose sensor 630 on the left arm "L" of the user. In some embodiments, the display information provided by the display 614 can automatically rotate. This will allow the user to read the information "right side up" without the inconvenience of having to present "upside down" text from a display that does not have an automatic rotation feature. Thus, the orientation of the information display will help the user quickly identify whether the sensor is on the left arm or the right arm of the user.

[0069] The instructions to select the orientation of the information display according to the orientation stored from the last scan, for example, until the glucose sensor is scanned on the opposite side, can be stored in memory and executed by the processor. The instructions can be implemented according to user input or according to sensed conditions, such as a change in the direction of gravity sensed by an on-board accelerometer. Alternatively, the information provided by the display 614 can not automatically rotate, such that the information remains stationary regardless of the orientation of the housing or which arm is being scanned.

[0070] While embodiments have been illustrated and described, it is to be understood that changes and modifications can be made by those skilled in the art, without departing from the spirit and scope of the following claims. In addition, while a particular feature of the embodiments can have been disclosed with respect to only one of several embodiments, such feature can be combined with one or more other features of the other embodiments as to an application of any given or particular function or techniques. It is therefore intended that such changes and modifications that have eluded the spirit and scope of the claims attach hereto.

[0071] Further, to the extent that the terms "including", "includes", "having", "has", "with", or variants thereof are used in either the detailed description and the claims, such terms are intended to be inclusive in a manner similar to the term "comprising". As used herein, the phrase "one or more of", for example, A, B and C, means any of the following: A alone, B alone, C alone; any two of the following: A and B, B and C, and A and C; or all three of A, B and C.

[0072] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the aspects disclosed herein. The specification and examples are exemplary only, with the true scope and spirit of the embodiments being indicated by the following claims.

Claims

1. A cap for a drug delivery pen, comprising: The detector mechanism includes: outer shell; Inner shell, the inner shell comprising The first open end is configured to receive a drug delivery pen. The second end, which is opposite to the first open end and defines a needle receiving chamber, and A sidewall having an outer surface and an inner surface, the sidewall extending between the first open end and the second end, and Channels that extend through the inner shell, At least one switch in an electronic circuit; A translatable shaft, at least partially disposed in the channel and comprising a body extending at least from a pen engagement portion in a pen receiving chamber to its switch engagement portion, wherein the translatable shaft is slidably disposed in the channel via a first opening and a second opening, and is oriented to travel from a first position to at least a second position to toggle the at least one switch. The translatable axis deviates from and travels in a direction parallel to the central axis of the inner shell, and the translatable axis is configured to return to the first position after the drug delivery pen is removed; and A piston return section is configured to automatically cause the translational axis to return to the first position after the drug delivery pen is removed; The translatable shaft includes a limiter comprising a collar assembly or an integrated shoulder portion having a diameter larger than the diameter of a second opening in the channel to prevent the translatable shaft from sliding completely through the channel.

2. The cover according to claim 1, further comprising a first NFC antenna, a second NFC antenna, and an NFC reader, wherein the first NFC antenna is configured to receive at least one signal generated by an analyte sensor and is located between a first side of the outer shell and the inner shell, the second NFC antenna is configured to receive at least one signal generated by the analyte sensor and is located between a second side of the outer shell and the inner shell, and the NFC reader communicates with the first NFC antenna and the second NFC antenna.

3. The cover according to claim 1, further comprising: monitor; Memory; as well as A processor that communicates with the memory.

4. The cover according to claim 1, wherein the piston return portion further includes a spring positioned concentric with the translational shaft and disposed between the first opening and the switch engagement portion.

5. The cover according to claim 1, wherein the at least one switch is a normally open switch.

6. The cover according to claim 1, further comprising a seal.

7. The cover according to claim 6, wherein the seal comprises a protective cover seal extending about a portion of the translational axis that extends into the pen receiving chamber.

8. The cover according to claim 6 or 7, wherein the seal comprises a hydrophobic lubricant in the channel along the translational axis.

9. The cover according to any one of claims 1-7, further comprising a proximity sensor, wherein the proximity sensor is configured to sense the travel distance of the translational axis.

10. The cover according to claim 1, further comprising a seal configured to prevent moisture or other foreign matter from entering the inner chamber from the pen receiving chamber, wherein the seal is one of: a protective shield seal compressible between the first opening and the drug delivery pen; or a coating applied to the surface of the body of the translational shaft.

11. A method for detecting the usage time of a drug delivery pen, the method comprising: The drug delivery pen is received into a receiving chamber, which is defined by the sidewall of the cap according to any one of claims 1 to 10; A translational shaft is engaged within the channel to travel from a first position to at least a second position to toggle a switch in an electronic circuit, wherein the translational shaft deviates from and travels in a direction parallel to the central axis of the inner housing. Store the time of the last toggle switch activation; as well as Calculate the time elapsed since the most recent toggle switch was activated.

12. The method of claim 11, wherein the electronic circuit transmits an electronic signal to the processor after the switch is toggled by the translational axis.

13. The method of claim 11, wherein the method comprises: Send the time of the most recent toggle switch activation to the remote user interface; Displays the time since the last toggle switch was activated.

14. A diabetes management system, comprising: The cap for a drug delivery pen according to any one of claims 1 to 10, the cap comprising a piston-type detector mechanism, wherein the piston-type detector mechanism comprises: Channels that extend from the outer surface to the inner surface. At least one switch; A translational axis, at least partially disposed in the channel, wherein the translational axis is oriented to travel from a first position to at least a second position to toggle the at least one switch, wherein the translational axis deviates from and travels in a direction parallel to the central axis of the inner housing, and wherein the translational axis is configured to return to the first position after the drug delivery pen is removed. An analytical material sensor system that communicates wirelessly with the cover; and A remote user interface that communicates wirelessly with the cover.

15. The system of claim 14, wherein the remote user interface is wirelessly connected to the cloud.

16. The system of claim 14, wherein the wireless communication between the remote user interface and the cover comprises: Transmit the time of the most recent toggle of the switch and at least one read from the analyte sensor system to the remote user interface, and set or update treatment parameters.

17. The system of claim 15, wherein the wireless communication between the remote user interface and the cloud comprises: Report the time when the switch was most recently toggled and at least one read from the analyte sensor system to the cloud in order to perform at least one analysis and update the treatment parameters.

18. The system according to claim 14, characterized in that, The cover further includes a piston return section configured to automatically cause the translational axis to return to the first position after the drug delivery pen is removed.

19. A diabetes management system, comprising: The cap for a drug delivery pen according to any one of claims 1 to 10, the cap comprising a piston-type detector mechanism, wherein the piston-type detector mechanism comprises: Channels that extend from the outer surface to the inner surface. At least one switch; A translatable shaft, at least partially disposed in the channel, wherein the translatable shaft is oriented to travel from a first position to at least a second position to toggle the at least one switch, wherein the translatable shaft deviates from and travels in a direction parallel to the central axis of the inner housing, and wherein the translatable shaft is configured to return to the first position after the drug delivery pen is removed; and A remote user interface that communicates wirelessly with the cover.

20. The system of claim 19, wherein the remote user interface is wirelessly connected to the cloud.

21. The system of claim 19, wherein the wireless communication between the remote user interface and the cover comprises: The time when the switch was last toggled is transmitted to the remote user interface, and treatment parameters are set or updated.

22. The system of claim 20, wherein the wireless communication between the remote user interface and the cloud includes reporting the time of the most recent toggle of the switch to the cloud for at least one analysis and updating treatment parameters.

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