Therapeutic Devices, Methods, and Systems Including Piston-Based Detectors

Abstract

To provide devices, methods and systems including a piston-style detector that can collect data about the timing of the removal and / or replacement of a cap from a dosing device.SOLUTION: The piston-style detector mechanism includes at least an inner shell having a first open end 603 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 opposing inner surface, and a passageway extending from the outer surface to the inner surface. The piston-style detector mechanism further includes at least one switch and a translatable shaft that are at least partially disposed in the passageway. The translatable shaft includes a body that extends at least from a pen-interfacing portion in the pen-receiving cavity to a switch-interfacing portion thereof.SELECTED DRAWING: Figure 6A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application Nos. 62 / 667,085, filed May 4, 2018, and 62 / 667,111, filed May 4, 2018. The disclosures of the prior applications are considered part of the disclosure of this application and are incorporated herein in their entireties.

[0002] The present invention relates to devices, methods, and systems that include a piston-type detector. In certain embodiments, the piston-type detector can be located in a cap of a medication dispensing device, such as a medication delivery pen. The devices, methods, and systems provided herein can collect data regarding the timing of cap removal and / or replacement from the medication dispensing device, which can optionally be used to determine treatment settings and / or treatment recommendations. [Background technology]

[0003] Diabetes is a chronic metabolic disorder caused by the inability of a person's pancreas to produce sufficient amounts of the hormone insulin and the inability of the person's metabolism to provide adequate absorption of sugar. This disorder leads to hyperglycemia, i.e., the presence of excessive amounts of glucose in the blood plasma. Persistent hyperglycemia Diabetes is associated with a variety of serious and life-threatening long-term complications, including dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage with the risk of limb amputation. Self-monitoring of blood glucose levels and self-administration of insulin are typical methods for treating diabetes. The "right" insulin dose is a function of blood glucose levels. Insufficient insulin doses can lead to hyperglycemia, while excessive insulin doses can lead to hypoglycemia, which can lead to clumsiness, speech problems, confusion, loss of consciousness, seizures, or death. Therefore, people with diabetes (PWD) face a significant cognitive burden when determining the appropriate insulin dose.

[0004] Data collected about the treatment of PWD can be used to improve treatment decisions, so reliable and robust data collection tools are needed. Summary of the Invention

[0005] In one embodiment, there is a pen cap for a medication delivery pen that includes a piston-type detector mechanism. The piston-type detector mechanism includes an inner shell having at least a first open end into which a medication delivery pen can be inserted, a second end opposite the first end, a sidewall defined by an outer surface and an opposing 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 cavity therebetween. The piston-type detector mechanism further includes at least one switch at least partially disposed within the passageway and a translatable shaft. The translatable shaft includes a body extending from a pen interface portion within at least the pen-receiving cavity to a switch interface portion thereof. The translatable shaft is oriented to move from a first position to at least a second position during capping of the medication delivery pen within the inner shell to toggle the at least one switch.

[0006] In one embodiment, there is a method for detecting capping of a medication delivery pen, the method comprising: capping the medication delivery pen with a pen cap including a piston-based detector mechanism; and during capping, transmitting movement of the medication delivery pen to a translatable shaft of the piston-based detector mechanism such that a switch interface portion interfaces with and switches a switch.

[0007] In one embodiment, there is a system including a pen cap including a piston-type detector mechanism, an analyte sensor system in communication with the pen cap, the analyte sensor including a blood glucose meter, a flash glucose monitor, or a continuous glucose monitor, and further including a mobile computing device, wherein the cap is in wireless communication with the mobile computing device.

[0008] Additional advantages of the embodiments will be set forth in part in the description that follows, and in part will be understood from the description, or may be learned by practice of the embodiments. The advantages will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the embodiments, as claimed.

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present teachings and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0011] [Figure 1A] FIG. 1 illustrates a diabetes management system that may include an embodiment of the pen cap described herein, including an insulin injection pen, a glucose sensor, and a mobile device. [Figure 1B] 1A and 1B illustrate how a PWD can apply a glucose sensor to their arm to detect their blood glucose level, and how a user can interrogate the glucose sensor using a pen cap, including an embodiment of the pen cap described herein, secured to a rapid-acting insulin pen. [Figure 1C] FIG. 10 illustrates information such as time of day, recommended dosage, and meal recommendations that may be displayed on the display of the cap of one embodiment based on, for example, a capping or decapping event. [Figure 1D] FIG. 10 illustrates information such as time of day, recommended dosage, and meal recommendations that may be displayed on the display of the cap of one embodiment based on, for example, a capping or decapping event. [Figure 1E]FIG. 10 illustrates information such as time of day, recommended dosage, and meal recommendations that may be displayed on the display of the cap of one embodiment based on, for example, a capping or decapping event. [Figure 2] FIG. 1B illustrates an exemplary communications architecture for the system shown in FIG. 1A. [Figure 3A] FIG. 1 is a perspective view of a pen cap including a piston-type detector mechanism according to one embodiment. [Figure 3B] FIG. 1 is a perspective view of a pen cap including a piston-type detector mechanism according to one embodiment. [Figure 3C] 1 is a perspective view of a pen cap including a piston-type detector mechanism according to one embodiment, and an enlarged (top) view of the piston-type detector. FIG. [Figure 3D] 1 is a perspective view of a pen cap including a piston-type detector mechanism according to one embodiment, and an enlarged (bottom) view of the piston-type detector. FIG. [Figure 3E] FIG. 3D is a cross-sectional view of the inner shell of the pen cap of FIGS. 3A-3D. [Figure 4A] 10A-10C are cross-sectional views illustrating the operation of a piston-type detector mechanism when a medication delivery pen with an attached needle is inserted into the pen cap of one embodiment. [Figure 4B] 10A-10C are cross-sectional views illustrating the operation of a piston-type detector mechanism when a medication delivery pen with an attached needle is inserted into the pen cap of one embodiment. [Figure 5A] 10A-10C are cross-sectional views illustrating the operation of a piston-type detector mechanism when a medication delivery pen without an attached needle is inserted into one embodiment of a pen cap. [Figure 5B] 10A-10C are cross-sectional views illustrating the operation of a piston-type detector mechanism when a medication delivery pen without an attached needle is inserted into one embodiment of a pen cap. [Figure 6A] 1A-1C are perspective views of different levels of detail of a pen cap including at least two NFC antennas, according to one embodiment. [Figure 6B] 1A-1C are perspective views of different levels of detail of a pen cap including at least two NFC antennas, according to one embodiment. [Figure 6C] 1A-1C are perspective views of different levels of detail of a pen cap including at least two NFC antennas, according to one embodiment. [Figure 6D] FIG. 6C is a perspective view of a dual NFC antenna that can be incorporated for use in the pen cap of FIGS. 6A-6C. [Figure 7A] 6A-6C illustrate how a PWD can apply a glucose sensor to their right arm to detect their blood glucose level, and how a user can use the pen cap of FIGS. 6A-6C secured to a rapid-acting insulin pen to interrogate the glucose sensor on their right arm. [Figure 7B] 6A-6C illustrate how a PWD can apply a glucose sensor to their left arm to detect their blood glucose level, and how a user can use the pen cap of FIGS. 6A-6C secured to a rapid-acting insulin pen to interrogate the glucose sensor on their left arm. DETAILED DESCRIPTION OF THE INVENTION

[0012] It should be noted that some details in the figures have been simplified and are drawn to facilitate understanding of the present teachings rather than to maintain strict structural accuracy, detail, and scale.

[0013] Reference will now be made in detail to the present embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0014] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the embodiments are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein should be understood to encompass all subranges encompassed therein. For example, a range "less than 10" can include all subranges between (and including) a minimum value of 0 and a maximum value of 10, i.e., all subranges having a minimum value greater than or equal to zero and a maximum value less than or equal to 10, e.g., 1 to 5. In some cases, the numerical values ​​recited for a parameter may be negative. In this case, example values ​​in a range recited as "less than 10" can assume negative values, e.g., -1, -2, -3, -10, -20, -30, etc.

[0015] The following embodiments are described for purposes of illustration only, with reference to the drawings. Those skilled in the art will appreciate that the following description is exemplary in nature and that various modifications can be made to the parameters described herein without departing from the scope of the present embodiments. The specification and examples are intended to be considered merely exemplary. Various embodiments are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments. It will be understood that structures shown in the drawings may include additional features not shown for simplicity, and that shown structures may be removed or modified.

[0016] The pen caps provided herein can use any suitable technique for obtaining pen capping information. In some cases, the pen caps provided herein extend into the injection pen, which receives, among other things, an inner shell of the pen cap, contacts the injection pen when the injection pen is inserted into the pen cap, and contacts the injection pen when the pen cap is secured to the injection pen. The sensor may include a piston-type detector mechanism including a piston that is forced against the switch.

[0017] In an exemplary embodiment of the therapy management system provided herein, FIG. 1A below shows a diabetes management system 10 including insulin injection pens 110, 120, a glucose sensor 130, and a mobile device 140. The mobile device may be any suitable computing device, such as a smartphone or tablet. The mobile device may store and execute a mobile application adapted to display therapy-related information received wirelessly from other components of the system.

[0018] As shown, each insulin injection pen 110, 120 includes a respective pen cap 112, 122, each including buttons and a display. In the embodiment shown in FIG. 1 , the insulin pens may be commercially available mechanical insulin pens containing any suitable insulin, including long-acting insulins and fast-acting insulins (sometimes referred to as fast-acting insulins or ultra-rapid-acting insulins). Suitable fast-acting insulins include Humalog™, Novolog™, Apidra™, and Fiasp™. Suitable long-acting insulins include Lantus™, Levemir™, Toujeo™, and Tresiba™. As shown, insulin injection pen 110 represents an exemplary long-acting insulin pen, and insulin injection pen 120 represents an exemplary fast-acting insulin pen.

[0019] As shown, the pen caps 112, 122 may have different colors, shapes, or other indicia, which may be physical or digital, to help a person with diabetes (PWD) distinguish the long-acting pen cap 112 from the fast-acting pen cap 122. The pen caps may communicate wirelessly with the mobile device 140 so that data from the pen caps can be received and displayed by the mobile application.

[0020] The glucose sensor 130 may be any suitable glucose sensor, such as a blood glucose meter (BGM), a flash glucose sensor, or a continuous glucose meter (CGM). In some cases, the glucose sensor may transmit data wirelessly (e.g., using NFC communication) when interrogated by a reader device. In some cases, the glucose sensor 130 may transmit data wirelessly (e.g., using radio frequency) at predetermined intervals using any suitable communication standard (e.g., BLE). In some cases, the glucose sensor 130 may transmit glucose data using multiple communication technologies. In some cases, the mobile device 140 and / or one or more insulin injection pens or pen caps may include an NFC reader adapted to acquire blood glucose data from the glucose sensor when brought within 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 pen caps 112, 122 may wirelessly receive blood glucose data broadcast from the glucose sensor 130 at predetermined times (e.g., every minute, every five minutes, etc.).

[0021] When using the exemplary diabetes management system 10, the PWD (or their caregiver) can be responsible for determining when and how much insulin to inject, but the system 10 can help the PWD (or caregiver) determine the appropriate insulin dose based on current data from a glucose sensor, based on stored treatment parameters, and / or based on data regarding insulin injections. In some cases, the pen cap can provide data about when the last insulin injection was administered by using data from a piston-type detector mechanism provided herein. For example, the pen caps 112, 122 can use the piston-type detector mechanism provided herein to detect when each pen cap is reapplied to its insulin injection pen, which can be assumed to be the time of injection. In some cases, the pen caps 112, 122 can track the remaining insulin in the insulin injection pen and determine the amount of each dose. Tracking and quantity determination functionality is described in pending U.S. patent applications 62 / 599,963 and 62 / 648,064, all of which are incorporated herein by reference, and published patent and application numbers WO 2017 / 009724 A1, U.S. Pat. No. 8,817,258 B1, and EP 2987 518 B1, all of which are incorporated herein by reference.

[0022] FIG. 1B illustrates how a PWD 20 can apply a glucose sensor 130 to their arm to detect the PWD's blood glucose level and how a user can interrogate the glucose sensor 130 using a pen cap 122 secured to a rapid-acting insulin pen 120. Before and / or after a user swipes the pen cap 122 in FIG. 1B , the pen cap 122 can display treatment-related information. In some cases, the treatment-related information can include information regarding one or more recent insulin doses, glucose data, and / or one or more insulin dose recommendations. For example, the pen cap 122 can display the time of the most recent dose before or after it is swiped. In some cases, before the pen cap 122 is swiped adjacent to the glucose sensor 130, the pen cap 122 can display a recommended meal dose of insulin without a correction component. In some cases, the pen cap 122 can display a recommended correction dose or a recommended meal and correction dose after the pen cap 122 is swiped adjacent to the glucose sensor 130.

[0023] For example, Figure 1C shows that the display 124 on the pen cap 122 can display the most recent dose, or "last dose" time 125. The time 125 can help the user remember if they administered a bolus for a recent meal and / or or help the user avoid unintentional bolus stacking. In some cases, such as with a dose-detecting pen cap, the display may additionally display the number of units of the last dose. In some cases, the timing of the last dose may be a ticking clock to indicate how long ago the last dose was administered. In some cases, the display may show the most recently obtained blood glucose value and the time it was obtained. In some cases, the display may be an electronic ink display. In some cases, the display may include identification information (e.g., the user's name, such as a label such as "Sarah's Pen") and / or information about the type of insulin pen it is attached to (e.g., brand of insulin).

[0024] Figure 1D shows the pen cap 122 displaying blood glucose data 129, which may include a current blood glucose level and trend arrows that may be received from the glucose sensor 130 after capping the pen as shown in Figure 1B. Figure 1D also includes a recommended correction dose 127d and a corresponding correction dose icon 126d.

[0025] FIG. 1E shows a pen cap 122 with meal recommendations 127a-127c, which can be displayed for different meal sizes identified by meal icons 126a-126c. Additionally or alternatively, the meal icons 126a-126c can be personalized by the user to represent different types of meals (e.g., B, L, and D labels indicating breakfast, lunch, and dinner, or pictures of meal types such as salad icons, sandwich icons, and pasta icons). For example, during use, a user can press button 123 after viewing the screen of FIG. 1D to obtain meal recommendations. In some cases, the recommended meals can be based on meal amounts set by a healthcare professional, PWD, or caregiver using the mobile application during setup or updated by a healthcare professional, PWD, or caregiver. In some cases, the meal recommendations can be based on user-specific dosage parameters that are automatically updated by the system using an appropriate algorithm to update dosage parameters. In some cases, if the user has recently obtained a blood glucose level (e.g., within the past 5, 10, 15, 20, or 30 minutes), the meal recommendations 127a-127c may include both meal amounts and correction doses. In some cases, if the pen cap 122 identifies other recent doses without knowing the dose amount (e.g., by detecting the capping action of the pen cap within the past 3, 4, or 5 hours), the pen cap may refuse to add a correction component to prevent unintentional stacking of correction boluses. In some cases, the meal icons 126a-126c may indicate whether the recommendation includes a correction component. In some cases, an additional icon or display may indicate whether a recommended correction dose is included and / or the size of the recommended correction dose. In some cases, by pressing button 123, the user may obtain a screen displaying the current blood glucose level, trend information (e.g., trend arrows), and recommended correction doses.In some cases, if there has been a recent administration of insulin (e.g., within the last 1, 2, 3, or 4 hours), a warning screen may appear next to or above the recommendation to indicate the recent administration to prevent unintentional stacking of insulin. In some cases, a notification icon 128 may appear on the pen cap 122 to indicate to the user that more detailed suggestions, tips, alerts, or alarms are available to the user in a mobile application on the mobile device 140.

[0026] In an exemplary embodiment, the pen cap 112 can be used with a long-acting insulin injection pen 110. As shown in Figures 1A-1E, the pen cap 112, 122 prevents the user from accidentally dispensing their long-acting insulin and their fast-acting insulin, as unintentional delivery of the wrong type of insulin can cause hypoglycemic or hyperglycemic events. The pen cap 112 may have distinct visual appearances (e.g., different colors) to help distinguish between the types of insulin. The pen cap 112 may include a button 113 and a display 114. When the button 113 is pressed by the user, the display may remind the user (via an appropriate icon 116) about the amount of long-acting insulin 117 the PWD should inject based on the stored therapy parameters. In some cases, if the user recently uncapped the pen cap 112 from the pen 110, the display may show information about when the pen cap 112 was uncapped or other warnings to prevent unintentional double delivery of long-acting insulin. In some cases, the pen cap 112 may provide an audible notification to the user that it is time to deliver long-acting insulin based on the stored therapy parameters. In some cases, an appropriate therapy titration algorithm may suggest that the user change the stored therapy parameters and / or automatically update the stored therapy parameters related to the administration of long-acting insulin. In some cases, the pen cap 112 can be configured to send a notification to the mobile application to inform the user that it is time to deliver an missed long-acting insulin dose (e.g., if no long-acting insulin has been administered in the past 24 hours). In some cases, the pen cap 112 can interrogate the glucose sensor 130 to receive glucose data and / or receive blood glucose data via the mobile device 140 and / or the pen cap 122. In some cases, the display 114 can depict recent blood glucose data, the time of the data, and / or glucose trend data (e.g., trend arrows).

[0027] The pen caps 112, 122, as well as other methods, devices, and systems provided herein, can easily provide treatment-related information and / or treatment recommendations to a user and / or can collect and use pen-capping information.

[0028] The pen caps 112, 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 pen caps provided herein can be adapted to wirelessly receive glucose data from the glucose sensor and wirelessly transmit glucose data from the glucose sensor to the mobile computing device. In some cases, the pen caps provided herein can receive glucose data from the glucose sensor using a first wireless communication technology and transmit glucose data to the mobile computing device using a second wireless communication technology. In some cases, the first wireless communication technology may have a shorter expected communication range than the second communication technology. In some cases, a user must interact to obtain glucose data from the glucose sensor using the first communication technology, while transmission of glucose data via the second communication technology occurs automatically. In some cases, the pen cap uses NFC communication with the glucose sensor 130, requiring the user to place the pen cap adjacent to the glucose sensor 130, which can be placed subcutaneously on the person's body, to obtain glucose data. In some cases, the pen cap can use BLE communication with the mobile computing device. The BLE communication can be triggered periodically and / or automatically after receiving glucose data at the pen cap from the glucose sensor. In some cases, the mobile device 140 can also receive glucose data from the glucose sensor using any suitable technique, and the glucose data can be transmitted from the mobile computing device 140 to the pen cap 112 or 122. In some cases, the glucose data transmitted from the glucose sensor to the pen cap in a single transmission can include data that the pen cap can use to determine at least two estimated glucose values ​​(EGVs) for a period spanning at least 30 minutes. In some cases, a single transmission can include at least one hour of glucose data, at least The glucose data may include 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.

[0029] The pen caps 112, 122 may include one or more processors and memory for controlling wireless communications, controlling a user interface, and / or determining treatment recommendations. In some cases, the pen caps provided herein may include a processor and associated memory that can be used with an algorithm to determine EGV from raw sensor data. In some cases, a glucose sensor may transmit EGV. In some cases, the pen caps provided herein may include memory that stores user-specific dosage parameters (e.g., a recommended daily dose or total daily basal dose (TDBD) of long-acting insulin, an insulin sensitivity factor (ISF), a carbohydrate-to-insulin ratio (CR), a total daily insulin dose (TDD), a target glucose value, etc.). In some cases, the user-specific dosage parameters may be time- or day-dependent, such as CR and ISF values ​​that are time-dependent of the day. In some cases, the pen caps provided herein may have memory that stores recommended dosages of fast-acting insulin for different meals or different meal categories. In some cases, the user-specific dosage parameters and / or different recommended dosages for different meals may be updated via a mobile computing device via wireless communication with the pen cap. For example, an algorithm on a mobile computing device or in the cloud can update these parameters or recommended dosages. In some cases, the parameters or recommended dosages can be updated by a medical professional or manually by the PWD or caregiver. In some cases, the pen cap can include algorithms in memory that a processor executes to update user-specific dosage parameters or recommended dosages.

[0030] The pen caps provided herein may, in some cases, display or notify the user of their current blood glucose level and / or blood glucose trend data (e.g., rate of change) based on glucose data received from a continuous glucose monitor, a flash glucose monitor, a blood glucose meter, or other suitable glucose sensor. The pen caps provided herein may also provide recommended insulin dosages based on one or more of the blood glucose data, user-specific dosage parameters, recommended dosages set by the user or a medical professional, time of day, meal data or classification, or other suitable input.

[0031] The pen capping information (i.e., information regarding when the pen cap is secured to and / or released from the injection pen) may include information regarding the current capping period (e.g., time since last capping), information regarding the duration of one or more uncappings, and the timing of each uncapping and each capping (e.g., time of day or elapsed time). In some cases, the pen capping information may be displayed to the user on the pen cap. In some cases, the pen capping information may be announced by a speaker on the pen cap. For example, in some cases, the pen cap may provide a timer clock that counts up from when the pen cap was last secured to the injection pen. In some cases, the pen cap may wirelessly communicate the pen capping information to a mobile device 140 (e.g., a smartphone, tablet, etc. running a mobile application).

[0032] The pen capping information can be used to tailor the user experience / behavior. In some cases, the pen cap tailors the presentation of therapy-related information and / or recommendations provided to the user based on the pen capping information. For example, in some cases, the pen cap may provide a bolus recommendation to correct an elevated blood glucose level based on data from a glucose sensor, but may tailor the presentation of such correction bolus recommendations based on the data from the glucose sensor. , the current pen capping period may be limited to a period longer than a threshold period (e.g., at least 3 hours, at least 4 hours, or at least 5 hours). In some cases, the pen cap may provide a notification, alert, or alarm to the user based on the pen capping information. For example, if the pen cap is removed from the injection pen within a threshold period (e.g., within 30 minutes or 1 hour) of the previous capping, the pen cap may provide a visual, audible, or vibratory notification to indicate that the user may have recently used the pen to administer insulin. In some cases, the pen cap may wirelessly communicate with a mobile computing device (e.g., a smartphone, a tablet), and one or more notifications, alerts, or alarms based on the pen capping information may be announced or displayed on the mobile computing device.

[0033] The pen capping information can be stored, displayed, and analyzed in combination with glucose data to determine user behavior, such as whether a person is appropriately administering insulin for a meal and / or whether to correct an elevated blood glucose level. In some cases, the pen capping information can be presented in a graphical representation of the user's blood glucose data and presented to the user and / or a medical professional. In some cases, the blood glucose data for a period of time after each capping event can be evaluated to determine whether the user appropriately administered insulin for that uncapping event and whether the user underdosed or overdosed.

[0034] FIG. 2 illustrates an exemplary communications architecture for the system shown in FIG. 1A, illustrating possible communication links between the system's components. The various components can interface with each other via controlled radio, NFC, or BLE protocols. Each of these components displays, transmits, and receives information based on the system workflow ongoing at a given time. As shown, the glucose sensor 130 can communicate with the rapid-acting pen cap 122, communication link 231, and / or the mobile device 140, communication link 232, via NFC. In some cases, the long-acting pen cap 112 can communicate with the glucose sensor 130 via NFC communication. In some cases, the long-acting pen cap 112 does not communicate directly with the glucose sensor via NFC to prevent user confusion because only fast-acting insulin should be used for correction or meal doses. In some cases, the glucose sensor 130 can further communicate with the mobile device via radio, transmitting blood glucose values ​​at predetermined intervals. Both pen caps 112, 122 can communicate with the mobile device 140 via BLE communication. Glucose data, programmed therapy parameters (e.g., daily dosage of long-acting insulin, dosages of various meal sizes (which may vary depending on the time of day), insulin sensitivity factors, carbohydrate-to-insulin ratios, etc.), pen cap data (and optionally dosage data if detected by the pen cap) can be exchanged between the mobile device 140 and each pen cap 112, 122, and system data can be exchanged with a web service 250 (which may be any remote server) via a WiFi or cellular connection 241. In some cases, each pen cap can include a processor and memory configured to execute algorithms that determine recommended dosages. In some cases, the mobile device can execute therapy recommendation or therapy parameter update algorithms to recommend changes to programmed therapy parameters and / or automatically update programmed therapy parameters.In some cases, the web service 250 may execute algorithms to recommend changes to programmed treatment parameters and / or automatically update programmed treatment parameters.

[0035] In some cases, initial treatment parameters are programmed into a mobile application on the mobile device 140 and transmitted to the pen cap via BLE communication links 211, 221. In some cases, the pen cap 122 can recommend correction doses and meal doses using the treatment parameters received from the mobile app. In some cases, the treatment parameters can include meal portions for different or differently sized meals (e.g., small meals, medium meals, and large meals or breakfast, lunch, dinner or salads, sandwiches, and pasta). In some cases, the treatment parameters can include treatment parameters for correcting blood glucose levels, such as insulin sensitivity factors. In some cases, the pen cap 112 can receive treatment parameters indicating a daily dose of long-acting insulin. In some cases, the pen cap 112 can receive recommended times for administering long-acting insulin (e.g., 9 PM daily, 8 AM daily, twice a day at 8 AM and 8 PM, etc.) from the mobile application 140 on the mobile device.

[0036] The pen cap can also be configured to provide insight into dosage recommendations that the user is likely to follow. For example, as described in U.S. Patent Application No. 15 / 717,805, the pen cap (whether or not it has a dose capture feature built into the pen cap) can include meal notification classifications (e.g., S, M, L), and data for each notification can indicate whether the user is likely to have administered the appropriate amount for the S, M, or L meal. U.S. Patent Application No. 15 / 717,805 is incorporated herein by reference. In some cases, the button on the pen cap 122 can be pressed multiple times to indicate successive recommendations for an S meal, an M meal, and an L meal, and the methods and systems provided herein can assume the user has administered insulin based on the last displayed recommendation. In some cases, information added via a mobile application indicating the amount of insulin remaining in the pen at various intervals (daily, every few days, weekly) can indicate whether the user is generally following the recommended regimen or ignoring it. In some cases, the methods and systems provided herein can analyze glucose data, pen capping information, data regarding the amount of insulin remaining in one or more pens, and / or responses to questions posed via a mobile app to determine a likelihood or assessment of the user's compliance with a recommended dosage, which can be used by the methods and systems provided herein to determine whether to adjust the recommended dosage or provide coaching to the user.

[0037] The methods and systems provided herein may further include a mobile application executing on a mobile device (e.g., a smartphone or tablet) that wirelessly communicates (e.g., via BLE) with one or more pen caps described herein. In some cases, blood glucose data can be transmitted from the glucose sensor via the pen cap and / or directly from the glucose sensor. In some cases, the mobile application may have a user interface that displays a graphical representation of the blood glucose data. In some cases, the graphical display of the blood glucose data over time may include an indicator that conveys pen capping information.

[0038] To generate the above-described capping information, a mechanism for detecting capping and / or uncapping events can be incorporated into a pen cap, such as pen cap 112 and / or pen cap 122. FIGS. 3A-3D show a pen cap 312 for a medication dispensing device, such as a medication delivery pen (not shown). In FIG. 3A, pen cap 312 is shown as including an outer housing 301 that can house several components therein, as shown in FIG. 3B. Outer housing 301 can include first and second portions 301a and 301b connected together at a seam 302 to define first and second openings 304 and 306. First and second portions 301a and 301b can be secured together by friction, snap fit, welding, adhesive, melting, or other means. The connection may be made by any suitable coupling method. In some embodiments, the outer housing 301 may have a one-piece housing configuration (not shown).

[0039] Internal components, such as a display 314 and / or buttons 309, can be disposed in the external housing 301. The display, which may be an LCD, e-paper, LED, OLED, or any other suitable display, is viewable through an opening 308 in the external housing 301. The buttons 309 may be mechanical, spring-loaded, touch-responsive (i.e., touchscreen and / or tactilely responsive) buttons and may be accessible to a user through the opening 308 or a separate opening. The external housing 301, first portion 301a, and / or second portion 301b may comprise one or more types of plastic, metal, any other suitable material, combinations thereof, or any other suitable material. The housing may be provided in various degrees of transparency, including from substantially transparent (e.g., internal components can be seen through the housing) to substantially opaque (e.g., the interior cannot be seen through the housing). The housings may be manufactured by any suitable process for manipulating the material from which they are made, such as machining (e.g., CNC, lathe, etc.), additive manufacturing (e.g., 3D printing), injection molding, blow molding, casting, punching, laser cutting, etc.

[0040] As shown in the exploded view of pen cap 312 in FIG. 3B , piston-type detector mechanism 315 is disposed in outer housing 301 along with a display and buttons. The display, buttons, and piston-type detector mechanism 315 can be attached together to form a common unit, for example. The common unit can have a modular design, allowing each component to be individually attached / detached to / from the other components. For example, display 314, buttons 309, and piston-type detector mechanism 315 can be attached via a common support base (not visible), for example, and can be connected to a circuit board (not shown) along with a memory and a processor configured to communicate with the memory and execute instructions stored in the memory, and an on-board power source (not shown), such as a rechargeable battery.

[0041] The piston-based detector mechanism 315 includes an inner shell 350 designed to receive an insulin delivery pen, a piston assembly 360 configured to interact with the pen when secured to the pen cap (capping event) or removed from the pen cap (uncapping event), and electronic circuitry 370 configured to provide an electrical path for communicating a capping or uncapping event from the piston assembly to a circuit board and ultimately to a processor. For example, the electronic circuitry 370 transmits a signal when the piston assembly 360 interacts with the pen during capping or uncapping of the medication delivery pen through the opening 303.

[0042] The inner shell 350 includes a pen body fixing portion 351, a needle fixing portion 353, and an opening 303 through which the pen is inserted into the pen receiving cavity (not visible) and a passageway (not visible) to allow the piston assembly 360 access to the cap, as shown in Figures 3C-3E, 4A-4B, and 5A-5D and further described below.

[0043] As shown in the enlarged views of FIGS. 3C-3E , the inner shell 350 of the piston-type detector mechanism 315 can further include a second end 356 opposite the first end 303 and a sidewall 358 defined by an outer surface 352 and an opposing inner surface 354. The sidewall 358 extends between the first end 303 and the second end 356 and defines a pen-receiving cavity 351′. The second end 356 can further define a needle-receiving cavity 353′. The passageway 355 includes a first opening 355′ adjacent to the cavity 351′ and an opposing second opening 355″. The passageway 355 allows the translatable shaft 361 to pass through the inner shell 350. to allow the device to be slidably disposed through at least a portion of the

[0044] For example, electronic circuitry 370 includes at least one switch 371 that can be operated by piston assembly 360, such as in response to receiving medication delivery pen 380 in opening 303. The at least one switch can be a microswitch having a toggle arm 371'. In some embodiments, the at least one switch can be a "normally open" switch such that, when incorporated into the circuit, it defaults to an open circuit configuration without any external influence to toggle the switch. In some embodiments, the at least one switch can be a "normally closed" switch such that, when incorporated into the circuit, it defaults to an open circuit configuration without any external influence to toggle the switch.

[0045] The piston assembly 360 includes a translatable shaft 361 that can be at least partially disposed within the passageway 355. The translatable shaft 361 can include a body that extends from at least its pen interface portion 361″ to its switch interface portion 361′. As described further below and shown in more detail in FIGS. 4A-4B and 5A-5B , the translatable shaft 361 is oriented to move from a first position to at least a second position during capping of the medication delivery pen with a pen cap to toggle at least one switch. Upon removal of the pen, the translatable shaft 361 can be configured to return to the first position. For example, a piston return 363 can be configured to automatically return the translatable shaft 361 to the first position.

[0046] 4A-4B are cross-sectional views illustrating the operation of the piston-type detector mechanism when a medication delivery pen with an attached needle is inserted into one embodiment of the pen cap. As described above, the translatable shaft 361 can be slidably positioned within the passageway 355 via the first opening 355′ and the second opening 355″. During capping or uncapping of the medication delivery pen with the pen cap, the translatable shaft is oriented to move from a first position to at least a second position, as shown between FIGS. 4A and 4B and between FIGS. 5A and 5B. As shown, the piston return 363 can include a spring disposed concentrically with the shaft and disposed between the second opening 355″ and the switch interface portion 361′. To prevent the translatable shaft 361 from sliding completely through the passageway 355 into the pen receiving cavity 351′, the limiter 364 can include, for example, a collar component or an integrated shoulder portion having a wider diameter than the second opening 355″ of the passageway 355.

[0047] Additionally, the external housing 301 mates with the internal shell 350 of the piston-type detector mechanism 315 to define at least an internal cavity and prevent the ingress of moisture or other foreign matter that may be harmful to some components of the piston-type detector mechanism, such as, for example, circuitry 370 and at least one switch 371, which may be disposed separately or together within the internal cavity, e.g., between the internal shell 350 and the external housing 301. The external housing 301 and the internal shell 350 may mate to provide protection from the ingress of liquid into the internal cavity, thus forming a watertight internal cavity, or a cavity having a water resistance level of IPX5 or higher (IEC Standard 60529). A seal 365 may be disposed in the second opening 355'' to prevent the ingress of moisture or other foreign matter that may enter the internal cavity from the pen receiving cavity 351'. The seal may be a boot seal that may be compressed between the first opening 365' and the pen 380. Alternatively, the seal may be or further include a coating, for example a sealant and / or lubricant composition coated on the surface of the piston body.

[0048] In one embodiment, switch 371 may be configured to detect one, two, three, or different configurations. For example, toggle 371' can be switched between two different positions (e.g., a first position and a second position) or three different positions (first, second, and third). For example, toggle 371' can be in a first "open" toggle position in which the pen cap and pen are not secured to one another, and therefore the translatable shaft is home and unobstructed, and a second toggle position in which the pen cap is secured to an injection pen without a needle attached, causing the piston to move a first distance. Toggle 371' can also be in a third toggle position in which the pen cap is secured to an injection pen with a needle attached, causing the piston to move a second distance, which may be the first or second distance depending on the pen configuration.

[0049] The shape, size, and orientation of the piston can also be relied upon to provide various contact points with foreign objects, such as a pen inserted into the pen cap. 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, so that if the needle is locked, the piston moves the switch to the third toggle configuration, but only to the second configuration if the needle is not locked. In another example, the piston can have a diameter that gradually decreases along the length of the piston body from the first position to the second position, so that the switch can determine the relative depth of the pen inserted into the pen cap and, therefore, whether a needle is attached to the pen. Data regarding whether a needle is attached to the pen can be used to determine whether a user is likely to replace the needle between injections or retain the needle in the pen for multiple injections. In some cases, data regarding the needle attached to the pen can be used to determine the amount of needle resupply to the user and / or to provide instructions to the user regarding the appropriate needle replacement. In one embodiment, the switch may include a proximity sensor that detects the distance traveled by the translatable shaft, for example, to assess how far the medication delivery pen is inserted into the inner shell of the pen cap or whether the pen is fully inserted (i.e., secured) into the inner shell of the pen cap.

[0050] In one embodiment, the passage for the translatable shaft is configured parallel to the longitudinal axis of the inner shell. In one embodiment, the passage 355 for the translatable shaft 361 is configured offset from and parallel to the longitudinal axis of the inner shell. In one embodiment, the translatable shaft is positioned offset parallel to the central axis (b-b') of the inner shell 350 and moves in the direction (a-a'). Thus, detection of a capping or uncapping event can be made unaffected by the presence or absence of a needle on the pen because the interface location 383 between the pen and the piston-type detection mechanism is at the pen body shoulder 381.

[0051] Like the pen caps 112, 122 shown in FIGS. 1A-1E described above, the pen cap 312 may be included as part of a system that further includes an analyte sensor system (e.g., a blood glucose meter, a flash glucose monitor, or a continuous glucose monitor) that communicates with the pen cap and / or a mobile computing device that can be used to set treatment parameters, including one or more recommended dosages for different sized meals, insulin sensitivity factors, carbohydrate-to-insulin ratios, daily doses of long-acting insulin, or combinations thereof. The cap can wirelessly communicate with the mobile computing device, for example, to transmit dose timing data to a remote user interface. Wireless communication can include pairing the pen cap to the analyte sensor system, setting or updating treatment parameters, and transmitting treatment information. Wireless communication can include transmitting treatment information to the cloud for one or more analyses, updating treatment parameters, or a combination thereof. Wireless communication can also include information such as capping event data, analyte data, or a combination thereof.

[0052] The pen cap can include an NFC reader adapted to acquire blood glucose data from the glucose sensor when brought within interrogation distance of the glucose sensor. When the glucose sensor is applied to the PWD's arm to detect the PWD's blood glucose level, the PWD can swipe such pen cap secured to the rapid-acting insulin pen within interrogation distance of the glucose sensor to initiate interrogation of the glucose sensor.

[0053] 6A-6C show perspective views of a pen cap 612 for a medication dispensing device, such as a medication delivery pen (not shown). As shown, the pen cap 612 includes an outer housing 601, a display 614, and an inner shell 650 that mates with the outer housing 601. The inner shell 650 can include a first open end 603 through which a pen can be inserted, a second end 656 opposite the first end 603, and a sidewall defined by an inner surface opposite the outer surface, the sidewall extending between the first end (opening 603) and the second end, thereby defining a pen-receiving cavity (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 disposed between the housing and a first side of the inner shell 650. Meanwhile, the second NFC antenna 693 is configured to receive at least one signal generated by the transcutaneous sensor and may be disposed between the outer housing 601 and a second side of the inner shell 650. In one example, the inner shell 650 is disposed between the first NFC antenna 691 and the second NFC antenna 693.

[0054] The pen cap 612 for the medication delivery pen described herein may also include a memory (not visible), a processor in communication with the memory (not visible) configured to execute instructions stored in the memory, and an NFC reader (not visible) in communication with the processor.

[0055] Like the pen caps 112, 122 shown in FIGS. 1A-1E described above, the pen cap 612 may be included as part of a system that further includes an analyte sensor system (e.g., a blood glucose meter, a flash glucose monitor, or a continuous glucose monitor) that communicates with the pen cap and / or a mobile computing device that can be used to set treatment parameters, including one or more recommended dosages for different sized meals, insulin sensitivity factors, carbohydrate-to-insulin ratios, daily doses of long-acting insulin, or combinations thereof. The cap can wirelessly communicate with the mobile computing device, for example, to transmit dose timing data to a remote user interface. Wireless communication can include pairing the pen cap to the analyte sensor system, setting or updating treatment parameters, and transmitting treatment information. Wireless communication can include transmitting treatment information to the cloud for one or more analyses, updating treatment parameters, or a combination thereof. Wireless communication can also include information such as capping event data, analyte data, or a combination thereof.

[0056] As shown in FIGS. 6C-6D, an antenna for use with cap 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 base portion 695, a first substrate portion on which first NFC antenna 691 is disposed, and a second substrate portion on which second NFC antenna 693 is disposed. First NFC antenna 691 is separated from the base portion by a first flex or hinge portion 697. Second NFC antenna 693 is separated from the base portion by a second flex or hinge portion 699. The antennas can be connected to circuitry 670 via contacts 694. Stiffeners, such as those shown at 692, can be added to the antennas to prevent damage to the antennas. First The NFC antenna 691 and the second NFC antenna 693 may be disposed on opposite sides of the display 614. For example, the first NFC antenna 691 may be disposed on a first side of the display 614, and the second antenna 693 may be disposed on a second, opposite side of the display 614. The first NFC antenna 691 and the second NFC antenna 693 may be oriented substantially perpendicular to a primary display surface of the display 614. For example, the first NFC antenna 691 and the second NFC antenna 693 may each or separately be oriented at an angle between substantially parallel to the display 614 and substantially perpendicular to the display 614, e.g., at an angle of about 0° to about 90°, e.g., about 15° to about 85°, or even about 35° to about 65°, including about 45°, relative to the primary display surface of the display 614.

[0057] It should be noted that the features of cap 312 described above can be combined with the features of cap 612. For example, a cap for a medication device such as a medication delivery pen can include both a piston-type detector mechanism for detecting pen insertion / removal and a dual antenna system as described with first and second NFC antennas. Thus, inner shell 650 can include all the features of inner shell 350.

[0058] 7A-7B illustrate a method for detecting a signal generated by a sensor, such as an analyte sensor, which may be placed as a subcutaneous sensor. Specifically, the method describes how a PWD can apply a glucose sensor to their right arm (FIG. 7A) or left arm (FIG. 7B) to detect their blood glucose level, and how a user can use the pen cap of FIGS. 6A-6C secured to a rapid-acting insulin pen to interrogate the glucose sensor in either arm.

[0059] A pen cap 612 including a first NFC antenna 691 and a second NFC antenna 693 is positioned adjacent to an analyte sensor 631. In some embodiments, during placement of the pen cap adjacent to an analyte sensor 630 that may be placed subcutaneously on the right arm, as shown in FIG. 7A , the first antenna 691 is closer to the subcutaneous sensor than the second antenna 693. In one example, during placement of the pen cap adjacent to an analyte sensor 630 that may be placed subcutaneously on the right arm, as shown in FIG. 7B , the second NFC antenna 693 is closer to the subcutaneous sensor than the first NFC antenna 691. The NFC reader can be activated to alternately read between the first NFC antenna 691 and the second NFC antenna 693. 6A-6C, the first NFC antenna 691 and the second NFC antenna 693 can be disposed between the outer housing 601 and the inner shell 350 such that, when the pen cap 612 is oriented in a first orientation, e.g., with respect to the analyte sensor 630 (e.g., as in FIG. 7A ), the signal strength of the at least one signal generated by the analyte sensor is received with a higher strength by the first NFC antenna 691 than by the second NFC antenna 693. And, when the pen cap 612 is oriented in a second orientation, e.g., with respect to the analyte sensor 630 (e.g., as in FIG. 7B ), the signal strength of the at least one signal is received with a higher strength by the second NFC antenna 693 than by the first NFC antenna 691.

[0060] The pen cap 612 can be held in a first orientation when the user is holding the device while scanning a glucose sensor 630 applied to the right arm "R," as shown in FIG. 7A. Alternatively, the pen cap 612 can be held in a second orientation when the user is scanning a glucose sensor 630 applied to the left arm "L," as shown in FIG. 7B. In some implementations, the displayed information provided by the display 614 can be auto-rotated. This allows the user to read the information "right side up" without the inconvenience of text being displayed "upside down" by a display without auto-rotation capabilities. Thus, the displayed information The orientation helps the user quickly identify whether the sensor is on the left or right arm.

[0061] For example, instructions may be stored in memory and executed by a processor to select a display orientation based on the orientation of the last scanned side until the glucose sensor is scanned on the opposite side. The instructions may be executed based on user input or based on a sensed condition, such as a change in the direction of gravity sensed by an on-board accelerometer. Alternatively, the information provided by the display 614 may not auto-rotate, thereby remaining static regardless of the orientation of the housing or which arm is being scanned.

[0062] Although the embodiments have been illustrated with respect to one or more implementations, changes and / or modifications can be made to the illustrated examples without departing from the spirit and scope of the appended claims. Furthermore, while a particular feature of an embodiment may be disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of other implementations that may be desirable and advantageous for any given or particular function.

[0063] Furthermore, to the extent that the terms "including," "having," or variations thereof are used in either the detailed description or the claims, such terms are intended to be as inclusive as the term "comprising." As used herein, the phrase "one or more," e.g., A, B, and C, means either A, B, or C alone, or any of two combinations such as A and B, B and C, A and C, or any three combinations such as A, B, and C.

[0064] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the teachings disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the embodiments being indicated by the following claims.

Claims

1. 1. A method for detecting a time between uses of a medication delivery pen, comprising: receiving the medication delivery pen within a receiving cavity of an inner shell defined at least in part by a sidewall of a pen cap; moving a translatable shaft in a passageway through the inner shell from a first position to at least a second position while capping the medication delivery pen within the inner shell to toggle a switch in an electronic circuit; a processor in communication with the switch storing a most recent switching time of the switch; calculating the time lapse since the most recent toggling of the switch to determine the time elapsed between capping of the medication delivery pen; the translatable shaft includes a body at least partially disposed within the passageway and extending from the inner shell to the switch, and is slidably disposed within the passageway and oriented to move from a first position to at least a second position during capping of the medication delivery pen within the inner shell to toggle at least one switch; method.

2. the electronic circuit sends an electronic signal to a processor after the translatable shaft toggles the switch. The method of claim 1.

3. transmitting the latest switching time of the switch to a remote user interface; displaying the latest switching time of the switch on a display of the pen cap; further comprising: The method of claim 1.

4. The method further includes a timer clock that counts up from the time immediately after the pen cap is secured to the medication delivery pen. The method of claim 1.

5. The method further includes a step of announcing, via a speaker in the pen cap, the time elapsed since the most recent flip of the switch. The method of claim 1.

6. A pen cap for a medication delivery pen, comprising: an inner shell, at least one switch, a translatable shaft, and a processor in communication with the switch; the inner shell having a sidewall at least partially defining the inner shell and a passageway extending through the inner shell; the translatable shaft has a body at least partially disposed within the passageway and extending from the inner shell to the switches, and is slidably disposed within the passageway and configured to move from a first position to at least a second position to toggle at least one of the switches when a medication delivery pen is capped onto the inner shell; the processor stores the most recent time the switch was toggled and calculates the time elapsed since the most recent time the switch was toggled to determine the time elapsed between capping the medication delivery pen. Pen cap.

7. The method of claim 1, further comprising: providing a translatable shaft to transmit an electronic signal to a processor after the translatable shaft toggles the switch.

7. The pen cap according to claim 6.

8. The processor transmits the latest switching time of the switch to a remote user interface and displays the latest switching time of the switch on a display.

7. The pen cap according to claim 6.

9. The method of claim 8, further comprising: a timer clock that counts up from the time immediately after the pen cap is secured to the medication delivery pen.

7. The pen cap according to claim 6.

10. Further comprising a speaker configured to announce the time elapsed since the most recent toggling of the switch.

7. The pen cap according to claim 6.

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