CN211094134U - Caps for dosing devices - Google Patents

Abstract

A cover for a dosing device contains a piston detector mechanism. The piston detector mechanism includes at least one inner housing having: a first open end through which a drug delivery pen can be inserted; a second end opposite the first end; an outer surface and an opposing inner surface define a side wall; and a channel extending from the outer surface to the inner surface. The sidewall extends between the first and second ends, thereby defining a pen receiving chamber therebetween. The piston detector mechanism further includes at least one switch and a translatable shaft disposed at least partially in the channel. 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 toggle the at least one switch during capping of the drug delivery pen into the inner housing.

Description

Caps for dosing devices

technical field

The present invention relates to devices, methods and systems comprising piston detectors. In certain embodiments, the plunger detector may be located within a cap of a dosing device such as a drug delivery pen. The devices, methods, and systems provided herein can collect temporal data on removal and/or replacement of the cap from the dosing device, which temporal data can then be used to determine treatment settings and/or treatment recommendations.

Background technique

Diabetes is a chronic metabolic disorder in which the body cannot absorb sugar normally due to insufficient insulin secretion. This lack of insulin secretion results in hyperglycemia, the presence of excess glucose in the plasma. Chronic hyperglycemia can lead to a variety of severe symptoms and long-term life-threatening complications, such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage with the attendant risk of amputation . The typical approach to treating diabetes is self-monitoring of blood glucose and self-administration of insulin. However, the "correct" dose of insulin varies with the amount of glucose in the blood. Insufficient insulin doses can lead to hyperglycemia, while excessive insulin doses can lead to hypoglycemia. Low blood sugar can cause clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death. Consequently, people with diabetes (PWD) face a considerable cognitive burden in determining whether insulin doses are appropriate.

Collecting treatment data for PWD can be used to improve treatment decisions, so reliable and robust data collection tools are needed.

SUMMARY OF THE INVENTION

In one embodiment, a cap for a drug delivery pen contains 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 , which is defined by an outer surface and an opposing inner surface; and a channel 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 disposed at least partially in the channel. 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 toggle the at least one switch during capping of the drug delivery pen into the inner housing.

In one embodiment, a capping method for detecting a drug delivery pen comprises: capping a drug delivery pen within the cap sleeve containing the piston detector mechanism; during capping, capping the drug delivery pen Movement is communicated to the translatable shaft of the piston detector mechanism such that the switch engagement portion interacts with the switch to cause the switch to be toggled.

In one embodiment, a system includes: the cap including the piston detector mechanism; an analyte sensor system in communication with the cap, wherein the analyte sensor includes a blood glucose meter, ambulatory glucose monitoring A meter, or continuous glucose monitor, and a mobile computing device capable of wireless communication with the cover.

Some other advantages of the embodiments will be set forth in the following description, from which additional parts may be understood, or may be learned by practicing the embodiments. The advantages of the invention may be realized and attained by combining the elements pointed out in the appended claims.

Both the above discussion and the following detailed description are merely illustrative and explain the related art in the technical field of the present invention, and therefore should not be construed as limiting the scope of the claims.

Description of drawings

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 disclosed in this patent application.

1A illustrates a diabetes management system that may include embodiments described herein including a cap, an insulin injection pen, a glucose sensor, and a mobile device.

Figure 1B shows how a PWD can use a glucose sensor on the arm to detect the blood glucose level of the PWD, and how a user can use a cap, including an embodiment of the cap as described herein, that has been secured to the fast-acting insulin pen, from the glucose sensor retrieve data.

Figures 1C to 1E illustrate one embodiment of a cover that may display information such as time, recommended doses, and meal recommendations on the cover display when, for example, being capped or removed.

FIG. 2 illustrates an exemplary communication architecture for the system of FIG. 1A.

Figures 3A to 3D are perspective views of a cover containing the piston detector mechanism of the present invention, Figure 3C is a top side view (including a close-up view of the piston detector), and Figure 3D is a bottom side view (including the piston detector) close-up image).

Figure 3E is a cross-sectional view of the inner casing of the cover shown in Figures 3A-3D.

4A-4B are cross-sectional views of the piston detector mechanism in action when a drug delivery pen with a needle is inserted into the cap of an embodiment.

5A-5B are cross-sectional views of the piston detector mechanism in action when a needleless drug delivery pen is inserted into the cap of an embodiment.

6A-6C are perspective views of varying degrees of detail of a cover that includes at least two Near Field Communication (NFC) antennas in an embodiment.

6D is a perspective view of a dual NFC antenna that may be used in the cover sleeve of FIGS. 6A-6C.

Figures 7A to 7B show how a PWD can use a glucose sensor on the right arm (Figure 7A) or its left arm (Figure 7B) to detect the blood glucose level of the PWD, and how the user can use the cover in Figures 6A to 6C to secure the fast acting The insulin pen comes up to get data from the glucose sensor.

Notably, the drawings in the present disclosure have been simplified for a better understanding of the related art in the present disclosure and the drawings in the present disclosure do not strictly adhere to structural precision, detail and scale.

Detailed ways

Embodiments of the present disclosure are described in detail with reference to the accompanying drawings, some of which are shown in the accompanying drawings. Wherever possible, the same drawing numbers will refer to the same or corresponding parts.

Notwithstanding that the numerical ranges and parameters setting forth the broad application of the embodiments are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, is subject to certain error due to the standard deviation of its testing measurements. Furthermore, all ranges in this disclosure are to be understood to encompass any and all subranges subsumed therein. For example, a range of "less than 10" may include any and all subranges between (and including) a minimum value of zero and a maximum value of 10, that is, any and all subranges with values equal to or A minimum value greater than zero and a maximum value equal to or less than 10, such as 1 to 5. In some cases, values as stated for parameters may exhibit negative values. In this case, the numerical value in the range of "less than 10" may be a negative value, such as -1, -2, -3, -10, -20, -30, etc.

For illustrative purposes only, the following embodiments are described with reference to the accompanying drawings. Those skilled in the art will appreciate that the following detailed description is a description of non-limiting exemplary embodiments and that modifications may be made to the parameters set forth herein without departing from the scope of the embodiments of the present invention. The specification and examples should not be limiting, but are merely examples of embodiments. The different embodiments are not mutually exclusive, and some embodiments can be combined with one or more other embodiments to form new embodiments. It will be appreciated that the structures shown in the figures may be simplified, which may contain other features, and that structures shown in the figures may be removed or modified.

The caps in this disclosure may use any suitable technique to obtain pen capping information. In some cases, the caps of the present disclosure may have a piston detector mechanism that includes a piston that extends into the inner pen-receiving housing of the cap and is inserted into the pen-receiving inner housing of the cap. The cap contacts the injection pen when in the cap and presses against the switch when the cap is fastened to the injection pen.

In an exemplary embodiment of a therapy management system provided in the present disclosure, FIG. 1A below illustrates a diabetes management system 10 that includes insulin injection pens 110 and 120 , a glucose sensor 130 , and a mobile device 140 . The mobile device may be any suitable computer application device, such as a smartphone or tablet computer. The mobile device may store and execute a mobile application for displaying relevant treatment information wirelessly received from other components of the diabetes management system.

As shown, each insulin injection pen 110 and 120 includes a corresponding cover 112 and 122, each of which includes a button and a display, respectively. In the embodiment shown in Figure 1, the insulin pen may be a commercially available mechanical insulin pen containing any suitable insulin, including long-acting insulin and fast-acting insulin (sometimes referred to as fast-acting insulin or ultra-fast-acting insulin) ). Available as rapid-acting insulins are Humalog ^™ , Novolog ^™ , Apidra ^™ and Fiasp ^™ . Available as long acting insulins are Lantus ^™ , Levemir ^™ , Toujeo ^™ and Tresiba ^™ . As shown, the insulin injection pen 110 represents a long-acting insulin pen, while the insulin injection pen 120 represents a fast-acting insulin pen.

As shown, caps 112 and 122 may have unique colors, shapes, or other physical or digitally distinct features to assist patients with diabetes (PWD) in distinguishing between long-acting caps 112 and quick-acting caps 122 . The cover can communicate wirelessly with the mobile device 140 so that data from the cover can be received and displayed by the mobile application.

Glucose sensor 130 may be any suitable glucose sensor, such as a blood glucose meter (BGM) and ambulatory glucose sensor, or a continuous glucose sensor (CGM). In some cases, the glucose sensor may wirelessly transmit data as it is read by a reader device (eg, using NFC communication). In some cases, the glucose sensor 130 may wirelessly transmit data at predetermined intervals (eg, using radio frequencies) using any suitable communication standard (eg, BLE). In some cases, the glucose sensor 130 may transmit glucose data using a variety of communication techniques. In some cases, one or more of the mobile device 140 and/or the insulin injection pen or cap may include an NFC reader. The NFC reader may be adapted to obtain blood glucose data when within interrogation distance of a glucose sensor. In some cases, mobile device 140 and/or one or more of insulin injection pens 110, 120 or caps 112, 122 may wirelessly receive data from a glucose sensor at predetermined time intervals (eg, every minute, every 5 minutes, etc.) 130 broadcast blood glucose data.

When using the example diabetes management system 10, the PWD (or its caregiver) may be responsible for determining when and how much insulin to inject, but the system 10 may be based on current data from a glucose sensor, based on stored treatment parameters, and/or based on Data on insulin injections to assist PWDs (or caregivers) in determining appropriate insulin doses. In some cases, the cap can provide data as to when the last insulin injection was made based on the data reflected by the piston detector mechanism of the present disclosure. For example, caps 112 and 122 can be detected by the piston detector mechanism of the present disclosure when each cap is reapplied to its insulin injection pen, which can be considered the injection time. In some cases, the caps 112 and 122 can note the amount of insulin remaining in the insulin pen and can determine the amount of insulin per injection. Reference may be made to co-pending US Patent Application Nos. 62/599,963 and 62/648,064, both incorporated herein by reference, as well as the published patent and application number WO 2017/ 009724A1; US 8,817,258B1; and EP 2987 518B1.

FIG. 1B shows how the PWD 20 may apply the glucose sensor 130 to its arm to detect the blood glucose level of the PWD, and how the user may use the cap 122 fastened to the rapid-acting insulin pen 120 to read data from the glucose sensor 130 . Before and/or after the user slides the cover 122 in Figure IB, the cover 122 may display relevant treatment information. In some cases, the relevant treatment information may include information about the most recent insulin injection or injections, glucose data, and/or recommendations for one or more insulin doses. For example, the cover 122 can display the time of the most recent insulin dose before or after slipping. In some cases, before the cover 122 slips adjacent the glucose sensor 130, the cover 122 may display an insulin dosage recommendation for the meal that does not include a correction component. In some cases, after the cover 122 has slipped adjacent to the glucose sensor 130, the cover 122 may display a corrected insulin dosage recommendation or an insulin dosage recommendation for a meal and including a corrected portion.

For example, FIG. 1C shows a display 124 on the cover 122 that can display the most recent medication or "last medication" time 125. Time 125 may assist the user in recalling whether they have taken a medicament for a recent meal and/or help the user avoid accidental re-dosing. In some cases, such as when the cap is able to detect the dose administered, the display may additionally display the last dose value. In some cases, the last dose time may use a clock to indicate how much time has elapsed since the last dose. In some cases, the display may display the most recently measured blood glucose level and when it was measured. In some cases, the display may be an e-ink display. In some cases, the display may contain identifying information (eg, the user's name, such as a logo for "Sarah's Pen") and/or type information for his insulin pen (eg, the brand of insulin).

FIG. 1D shows a cover 122 presenting blood glucose data 129 . The blood glucose data 129 may include the current blood glucose level and a blood glucose level trend arrow, which may be received from the glucose sensor 130 after the cap is capped as shown in FIG. IB. Figure ID also contains a correction dose recommendation 127d and a corresponding correction dose icon 126d.

Figure 1E shows a cover 122 with meal dosage recommendations 127a-127c that may be given for different sized meals represented by meal icons 126a-126c. Additionally or alternatively, the user may personalize meal icons 126a-126c to represent different types of meals (eg, B, L, D labels to indicate breakfast, lunch, dinner, or pictures of meal types, such as the salad icon, the sandwich icon, and the macaroni icon). For example, in use, after seeing the display of Figure ID, the user may press button 123 to obtain meal dosage recommendations. In some cases, meal dosage recommendations may be given based on set values set by the healthcare professional, PWD, or caregiver during setup using the mobile app, or updated meal dosage updates by the healthcare professional, PWD, or caregiver value is given. In some cases, meal dosage recommendations may be given based on the user's personal dosage parameters that are automatically updated by the system using any suitable algorithm. In some cases, when the user has recently (eg, within the last 5, 10, 15, 20, or 30 minutes) reading blood glucose levels, the meal dose recommendations 127a-127c may contain both meal doses and corrected doses. In some cases, if the cap 122 has identified other recent dosing times (eg, by detecting capping actions within the last 3 hours, the last 4 hours, or the last 5 hours) without knowing the dose, the cap may Refuse to add the correcting amount to prevent accidental re-dosing of the correcting agent. In some cases, the meal icons 126a-126c may indicate whether the meal dosage recommendations include corrected portions. In some cases, additional icons or display data may be used to indicate whether the meal dosage recommendation includes a corrected dosage recommendation and/or how much of the suggested corrected dosage. In some cases, by pressing button 123, the user may see the display showing the current blood glucose value, trend information (eg, trend arrows), and a suggested correction dose. In some cases, if there has been a recent dose of insulin (eg, within the last 1, 2, 3, or 4 hours), a warning may appear near or above the corrected dose recommendation to alert the recent dose to prevent accidental re-use of insulin. In some cases, a notification icon 128 may be presented on the cover 122 to indicate to the user that more detailed advice, prompts, warnings or alerts are available to the user in a mobile application on the mobile device 140 .

Caps 112 and 122 and other methods, devices, and systems provided in the present disclosure can simply and easily provide a user with treatment-related information and/or treatment recommendations, while and/or collecting and using a pen to cap the information.

Covers 112 and 122 may be configured to communicate wirelessly with one or more glucose sensors and/or one or more mobile computing devices. In some cases, the covers provided in the present disclosure may 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 covers 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. Under certain circumstances, the first wireless communication technology may have a closer expected communication range than the second communication technology. In some cases, the user must obtain glucose data from the glucose sensor using the first communication technology, while the transmission of the glucose data occurs automatically via the second communication technology. In some cases, the cap communicates with the glucose sensor 130 using NFC and the user must place the cap close to the glucose sensor 130 that has been subcutaneously implanted in the body to obtain glucose data. In some cases, the cover can communicate with the mobile computing device using BLE. The BLE communication can be triggered at regular intervals and/or automatically after the cover receives glucose data from the glucose sensor. In some cases, mobile device 140 may also receive glucose data from a glucose sensor and may transmit glucose data from mobile computing device 140 to cover 112 or 122 using any suitable technique. In some cases, the glucose data may include data in a single transmission from the glucose sensor to the cap that enables the cap to determine at least two estimated glucose values (EGVs) over an interval extending to at least 30 minutes. In some cases, a single transmission of data may contain 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.

Covers 112 and 114 may contain one or more processors and memory for controlling wireless communications, controlling user interfaces, and/or determining treatment recommendations. In some cases, the covers provided in the present disclosure can include a processor and associated memory that, in conjunction with an algorithm, can determine EGV values from sensor raw data. Under some conditions, the glucose sensor may transmit an EGV value. In some cases, the caps provided in the present disclosure may include memory for storing the user's personal dosage parameters (eg, daily dosage 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's personal dose parameters may be time or day related parameters, eg, both CR and ISF values vary with the time of day. In some cases, the caps provided in the present disclosure may have memory for storing rapid-acting insulin dosage recommendations for different meals or for different meal categories. In some cases, the user's personal dosage parameters and/or different dosage recommendations for different meals may be updated via a mobile computing device in wireless communication with the cover. For example, algorithms in the mobile computing device or in the cloud may update these parameters or dosage recommendations. In some cases, parameters or dosage recommendations can be updated by a healthcare professional or manually by a PWD or caregiver. In some cases, the cap may contain an algorithm within the cap memory that, when executed by the processor, updates the user's personal dose parameters or dose recommendations.

In some cases, the covers provided in the present disclosure may display or otherwise inform a user based on glucose data received from a continuous glucose monitor, flash glucose monitor, blood glucose meter, or any other suitable glucose sensor Current blood glucose levels and/or blood glucose trend data (eg, rate of change). Covers provided in the present disclosure may also be based on blood glucose data, user personal metering parameters, dosage recommendations set by the user or a healthcare professional, time of day, meal data or meal category, or any other suitable One or more of the information in the input provides insulin dosage recommendations.

Pen capping information (ie, time information when the cap was fastened to and/or released from the pen) may contain information about the current capping period (eg, time elapsed since last capping) , time interval information about one or more capping and time information for each capping and each capping (eg, the specific time of capping each day or the elapsed time since the last capping). In some cases, the cap can display pen capping information for the user. In some cases, the pen capping information may be notified to the user by a speaker in the cap sleeve. For example, in some cases, the sleeve may provide a timer clock that counts the total elapsed time since the cap sleeve was last tightened until the injection pen. In some cases, the cap may wirelessly communicate pen capping information to the mobile device 140 (eg, a smartphone, tablet, etc. running a mobile application).

Pen plus capping information can be used to adjust the user experience. In some cases, the cap may adjust the user presentation of treatment-related information and/or recommendations based on the pen capping information. For example, in some cases, the cap may suggest a corrective dose of medicament capable of correcting elevated blood glucose levels based on data from the glucose sensor, but the cap may only work when the pen capping interval is greater than a threshold time period (eg, This corrective agent recommendation is presented at least 3 hours, at least 4 hours, or at least 5 hours). In some cases, the cap may provide a notification, warning, or alarm to the user based on the pen capping information. For example, if the cap is removed from the injection pen within a threshold period of time from the last decapping time (eg, within 30 minutes or 1 hour), the cap may provide a visual, audible or A notification with vibration to alert the user that the user may have recently injected insulin with the pen. In some cases, the cover can communicate wirelessly with the mobile computing device (eg, smartphone, tablet) and the mobile computing device can notify or display one or more notifications, warnings, or alerts based on the pen capping information.

Storing, displaying, and analyzing the pen capping information along with the glucose data can determine user behavior, such as whether the user is using insulin correctly for meals and/or correcting for elevated blood sugar levels. In some cases, the pen capping information may be presented on a graph of the user's blood glucose data and presented to the user and/or the healthcare professional at the same time. In some cases, evaluating blood glucose data over a period of time after each capping can determine whether the user is using insulin correctly at the time of capping and whether the user is under or overdosing.

FIG. 2 illustrates an exemplary communication architecture for the system of FIG. 1A, and illustrates possible communication links between components of the system of FIG. 1A. 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 according to the ongoing system workflow at a specific point in time. As shown, glucose sensor 130 may communicate with quick-acting cover 122, communication link 231 and/or with mobile device 140, communication link 232 via NFC. In some cases, the long-lasting cap 112 can communicate with the glucose sensor 130 via NFC communication. In some cases, the long-acting cap 112 does not communicate directly with the glucose sensor via NFC communication to prevent user confusion because the insulin used as a correction or meal dose is only rapid-acting insulin. In some cases, the glucose sensor 130 may additionally communicate with the mobile device via a radio that transmits blood glucose values at predetermined intervals. Both covers 112 and 122 can communicate with mobile device 140 via BLE communication. Blood glucose data, programmed therapy parameters (eg, daily dose of long-acting insulin, doses for different meal sizes (which may vary by time of day), insulin sensitivity factors, carbohydrate-insulin ratio, etc.), pen caps Data (with or without dose data detected by the cover) may be communicated between the mobile device 140 and each cover 112 and 122, and system data may be communicated via WiFi or cellular connection 241 to web service 250 (which Can be any remote server). In some cases, each cap may be configured with an included processor and memory to execute algorithms to determine dosage recommendations. In some cases, the mobile device may implement therapy recommendations or implement 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 implement algorithms to recommend changes and/or automatically update programmed therapy parameters.

In some cases, initial therapy parameters can be programmed into a mobile application on mobile device 140 and transmitted to the cover via BLE communication links 211 and 221 . In some cases, the cover 122 may provide corrected dosage and meal dosage recommendations using treatment parameters received from the mobile application. In some cases, treatment parameters can include meals for different or different sized meals (eg, small, medium, and large meals; or breakfast, lunch, and dinner; or salads, sandwiches, and pasta) food dose. In some cases, the treatment parameters may include treatment parameters for correcting blood glucose values, such as insulin sensitivity factors. In some cases, the cap 112 may receive a therapeutic parameter that specifies a daily dose of long-acting insulin. In some cases, the cap 112 may receive from the mobile device mobile application 140 a suggested time to use the long-acting insulin (eg, 9 pm daily, 8 am daily, 8 am and 8 pm twice a day, etc. ).

The cap can also be configured to understand dosage recommendations that the user may follow. For example, as described in US Patent Application Serial No. 15/717,805, a cover (whether or not the cover has a dose-capture feature) may contain a classification of meal notifications (eg, S, M, L), and each The data in the notification can indicate whether the user may have used the appropriate insulin dose for the S, M or L meal. US Patent Application No. 15/717,805 is incorporated herein by reference. In some cases, multiple presses of the button on the cover 122 may present dosage recommendations for subsequent S-meal, M-meal, and L-meal, and the methods and systems provided in this disclosure may assume that the user has Insulin was recommended for the dose shown at the previous time. In some cases, the information on the residual insulin level in the pen at various time intervals (once a day, once a few days, once a week) added on the mobile application may indicate whether the user is generally following treatment recommendations or whether the user is ignoring all treatment recommendations. In some cases, the methods and systems provided in the present disclosure may be implemented by analyzing glucose data, pen capping information, insulin remaining in one or more pens data, and/or answers to questions given in a mobile application. Determining or scoring the user's likelihood of following dosage recommendations. The methods and systems provided in the present disclosure can use this determined likelihood or score to determine whether a dosage adjustment is recommended or to provide guidance to the user.

The methods and systems provided in the present disclosure may also include a mobile application running on a mobile device (eg, a smartphone or tablet) that wirelessly communicates (eg, via BLE) with one or more covers in the present disclosure . In some cases, blood glucose data may be transmitted from the glucose sensor via the cap and/or directly from the glucose sensor. In some cases, the mobile application may have a user interface to graphically display blood glucose data. In some cases, a graph showing blood glucose data over time may include indicators conveying pen capping information.

In order to collect the capping and decapping information described above, a mechanism capable of detecting capping and/or decapping may be placed within the cap sleeve, such as in the cap sleeve 112 and/or the cap sleeve 122 . Figures 3A to 3D illustrate a cap 312 for use with a dosing device such as a drug delivery pen (not shown). In FIG. 3A, the cover 312 includes an outer casing 301, and several components can be accommodated in the outer casing 301, as shown in FIG. 3B. The outer 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 connected by friction, snap fit, welding, gluing, melting, or any other suitable bonding method. In some embodiments, the outer housing 301 may have a unitary spatial configuration (not shown).

Internal components such as display 314 and/or buttons 309 may be housed in outer housing 301 . Display 314 may be an LCD, e-paper, LED, OLED, or any other suitable display that is viewable through opening 308 in outer housing 301 . Button 309 may be a mechanical spring loaded button, a touch reactive button (ie, a touch screen and/or a tactile response) that a user may use via opening 308 or via a separate opening. The outer housing 301, the first portion 301a and/or the second portion 301b may comprise one or more of plastic, metal, any other suitable material, combination thereof, or any other suitable type of material. The housing may be of varying transparency, including from substantially transparent (eg, internal components can be seen through the housing) to substantially opaque (eg, the interior cannot be seen through the housing). The housing may be fabricated using any suitable manufacturing process and suitable materials thereof, such as machining (eg, CNC, turning, etc.), additive manufacturing (eg, 3D printing), injection molding, blow molding, casting, stamping , laser cutting, etc.

As shown in the exploded view of the cover sleeve 312 shown in Figure 3B, the piston detector mechanism 315 is housed in the outer housing 301 along with the display and buttons. The display, button and piston detector mechanism 315 may be attached together, eg forming a common unit. The common unit may have a modular design that enables 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, for example, on a common support base (not visible), and may be connected to a circuit board (not visible) along with a memory and a processor, which is not visible in communication with the memory and configured to execute instructions stored in the memory; and an on-board power source (not shown), such as a rechargeable battery.

The piston detector mechanism 315 includes: an inner housing 350 designed to receive the insulin delivery pen, a housing 350 that communicates with the insulin delivery pen when the insulin delivery pen is fastened to the cap (capping action) or removed from the cap (decapping action). The plunger assembly 360 that interacts with the insulin delivery pen and the electronic circuitry 370 that provides an electrical path for the plunger assembly to communicate the capping or decapping action to the circuit board and ultimately to the processor. For example, the electronic circuit 370 transmits a signal via the opening 303 when the piston assembly 360 interacts with the drug delivery pen while the drug delivery pen is being capped or decapped.

As shown in Figures 3C-3E, 4A-4B and 5A-5B and as further described below, the inner housing 350 includes a pen body securing portion 351, a needle securing portion 353 and an opening 303 through which the pen can pass Insert into the pen receiving chamber (not visible) and channel (not visible) to allow the piston assembly 360 to enter the cap.

As shown in the enlarged views of FIGS. 3C to 3E , the inner housing 350 of the piston detector mechanism 315 may further include a second end 356 opposite the first end 303 , and a side defined by an outer surface 352 and an opposite inner surface 354 wall 358. A side wall 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'. Channel 355 includes a first opening 355 ′ adjacent to chamber 351 ′ and an opposing second opening 355 ″. Channel 355 allows a translatable shaft 361 disposed in the inner housing to slide through at least a portion of inner housing 350 .

For example, the electronic circuit 370 includes at least one switch 371 that can be used by the piston assembly 360 when the drug delivery pen 380 is inserted through the opening 303, for example. The at least one switch may be a micro switch with a toggle arm 371'. In some embodiments, the at least one switch may be a "normally open" switch, whereby the at least one switch defaults to an open circuit configuration when there is no external influence in the circuit to toggle the switch. In some embodiments, the at least one switch may be a "normally closed" switch such that it defaults to an open circuit configuration when there is no external influence on the circuit to toggle the switch.

Piston assembly 360 includes a translatable shaft 361 that can be disposed at least partially in channel 355 . Translatable shaft 361 may include a body extending at least from pen engagement portion 361' to switch engagement portion 361" thereof. As described further below, and shown in greater detail in Figures 4A-4B and 5A-5B, the translatable The shaft 361 is oriented to travel from a first position to at least a second position to toggle at least one switch during capping of the drug delivery pen using the cap. After removal of the drug delivery pen, the translatable shaft 361 can be configured to return to First position. For example, piston return 363 may be configured to automatically return translatable shaft 361 to the first position.

4A-4B illustrate cross-sectional views of the operation of the piston detector mechanism when inserting a drug delivery pen with a needle into the cap of an embodiment. As described above, the translatable shaft 361 can be slidably seated in the channel 355 via the first opening 355' and the second opening 355". As shown in FIGS. The translatable shaft is oriented to travel from a first position to at least a second position when the delivery pen is capped or decapped. As shown, the piston return 363 may include a spring that engages the switch at the first opening 355" 361' are concentrically mounted on the translatable shaft. To prevent the translatable shaft 361 from sliding completely through the channel 355 and into the pen receiving chamber 351 ′, it may include a limiter 364 , such as a collar assembly or an integrated shoulder portion having a larger size than the channel 355 Second opening 355" wider diameter.

Additionally, the outer housing 301 cooperates with the inner housing 350 of the piston detector mechanism 315 to define at least an inner chamber to protect against moisture or any other possible hazards such as may be individually or together positioned within eg between the inner housing 350 and the outer housing 301 Foreign matter ingress of some components of the piston detector mechanism such as circuit 370 and at least one switch 371' in the chamber. The outer casing 301 may cooperate with the inner casing 350 to prevent liquids from entering the inner chamber thereby forming a waterproof inner chamber, or a chamber having a waterproof rating of IPX5 or better (IEC Standard 60529). To prevent moisture or any other foreign matter from entering the inner chamber from the pen receiving chamber 351 ′, a seal 365 may be positioned at the second opening 355 ″. The seal may be a boot seal, which may be located at the first opening 365 ' and the pen 380. The seal may also or further comprise a coating, such as a sealant and/or lubricant composition applied to the surface of the body of the piston.

In embodiments, switch 371 may detect one, two, three or different configurations. For example, toggle switch 371' can be toggled to two different positions (eg, first position and second position) or three different positions (first, second, and third). For example, toggle switch 371' can be in a first "off" toggle position, where the translatable shaft is in its original undisturbed position because the cap and pen are not fastened together; and toggle The movable switch 371' can be in a second toggle position, wherein the piston travels the first distance because the cap is fastened to the injection pen without the needle. The toggle switch 371' may additionally be in a third toggle position, wherein because the cap is fastened to the injection pen with the needle, the piston travels a second distance, which may be, depending on the configuration of the pen first or second distance.

The provision of various contacts for a foreign object, such as a pen, inserted into the cap may depend on the shape, size and orientation of the piston. For example, in some cases, the piston may 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 the third with the securing needle in place Toggle the configuration, but move to the second configuration without tightening the needle. In another example, the piston may have a diameter that decreases along the length of the piston body from the first position to the second position, such that the switch may determine the relative depth of insertion of the pen in the cover, thereby further determining whether the pen is inserted Comes with needles. The detected data of whether the inserted pen has a needle can be used to determine whether the user is likely to change the needle after each injection or use the same needle for multiple injections. In some cases, the detected data on whether the inserted pen has a needle can be used to determine the user's needle resupply amount and/or to provide the user with instructions for proper needle replacement. In an embodiment, the switch may include a proximity sensor to detect the distance traveled by the translatable shaft to analyze, for example, how far the drug delivery pen has been inserted into the cap inner housing or whether the drug delivery pen has been fully inserted (ie, fastened) to the in the inner shell of the cover.

In an embodiment, the channel for the translatable shaft is arranged parallel to the long axis of the inner housing. In an embodiment, the channel 355 for the translatable shaft 361 is configured to be parallel and offset from the long axis of the inner housing. In an embodiment, the translatable shaft is positioned parallel offset from the central axis (bb') of the inner casing 350 and travels in a direction (a-a') parallel to the central axis (bb') of the inner casing 350 . Therefore, the presence or absence of a needle on the pen has no effect on detecting the capping or decapping 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 .

Similar to caps 112 and 122 as described above and shown in FIGS. 1A-1E, cap 312 may be part of a system that further includes an analyte sensor system (eg, blood glucose meter, dynamic glucose monitor or continuous glucose monitor), and/or a mobile computing device that can be used to configure treatment parameters including dosage recommendations for different sized meals, insulin sensitivity factors, carbohydrate-insulin ratios, long daily dose of effective insulin or a combination of the above information. The cover can communicate wirelessly with the mobile computing device to transmit, for example, medication time data to a remote user interface. The wireless communication can include pairing the cap with the analyte sensor system, setting or updating therapy parameters, and sending therapy information. The wireless communication may include sending treatment information to the cloud for analysis, updating treatment parameters, or one or more of a combination of the above. The wireless communication may also include treatment information such as capping data, analyte data, or a combination of the above.

The cover may contain an NFC reader for reading blood glucose data from the glucose sensor when within interrogation distance of the glucose sensor. The blood glucose level of the PWD is detected by applying a glucose sensor to the arm, the PWD can swing the cap fastened to the fast-acting insulin pen within the interrogation distance of the glucose sensor to initiate the interrogation of the glucose sensor.

Figures 6A to 6C show perspective views of a cap 612 for a dosing device such as a drug delivery pen (not shown). As shown in the figure, the cover 612 includes an outer casing 601 , a display 614 and an inner casing 650 matched with the outer casing 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 opposite inner surface, wherein A sidewall extends between the first end (opening 603) and the second end, thereby defining a pen receiving chamber (not visible). The first NFC antenna 691 may be configured to receive at least one signal generated by the transcutaneous sensor. The first NFC antenna 691 may be located between the housing and the first side of the inner housing 650 . Meanwhile, the second NFC antenna 693 may be configured to receive at least one signal generated by the transcutaneous sensor and be located between the outer housing 601 and the second side of the inner housing 650. In one example, the inner case 650 is disposed between the first NFC antenna 691 and the second NFC antenna 693 .

A cover 612 for a drug delivery pen as described herein may 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 a communication with the processor NFC reader for communication (not visible).

Similar to caps 112 and 122 as described above and shown in FIGS. 1A-1E, cap 612 may be part of a system that further includes an analyte sensor system (eg, a blood glucose meter) in communication with the cap. , ambulatory glucose monitor, or continuous glucose monitor), and/or a mobile computing device that can be used to configure treatment parameters including recommended doses for different sized meals, insulin sensitivity factors, carbohydrate-to-insulin ratios , the daily dose of long-acting insulin, or a combination of the above information. The cover can communicate wirelessly with the mobile computing device to transmit, for example, medication time data to a remote user interface. Wireless communication can include pairing the cap with the analyte sensor system, setting or updating therapy parameters, and sending therapy information. Wireless communication may include sending therapy information to the cloud for one or more analyses, updating therapy parameters, or a combination of the above. The wireless communication may also include treatment information such as decapping data, analyte data, or a combination of the above.

As shown in FIGS. 6C-6D , the antennas used in the cover 612 include 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 portion of the substrate on which the first NFC antenna 691 is disposed, and a second portion of the substrate on which the second NFC antenna 693 is disposed. The first NFC antenna 691 is separated from the base portion by a first curved or hinged portion 697 . The second NFC antenna 693 is separated from the base portion by a second curved or hinged portion 699. The antenna may be connected to circuit 670 by means of contacts 694. A stiffener, as shown at 692, may be added to the antenna to prevent antenna damage. The first NFC antenna 691 and the second NFC antenna 693 may be positioned on opposite sides of the display 614 . For example, a first NFC antenna 691 may be positioned on a first side of display 614 and a second antenna 693 may be positioned on an opposite second side of display 614 . The first NFC antenna 691 and the second NFC antenna 693 may 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 each or be oriented substantially parallel to the display 614 or substantially perpendicular thereto, such as at an angle of about 0° to about 90° with respect to the main display surface of the display 614 , at an angle of about 15o to about 85o and even at an angle of about 35o to about 65o, including at an angle of about 45o.

It should be noted that the features of the middle cover sleeve 312 described above can be combined with the features of the cover sleeve 612 . For example, a cover for a dosing device such as a drug delivery pen may include both a piston detector mechanism for detecting insertion/removal of the pen and dual antennas with eg a first NFC antenna and a second NFC antenna system. Thus, inner housing 650 may contain any and all features of inner housing 350 .

Figures 7A-7B illustrate methods of detecting signals collected by sensors, eg, an analyte sensor may detect signals as a subcutaneous sensor. Specifically, the method describes how a PWD can use a glucose sensor on its right arm (FIG. 7A) or its left arm (FIG. 7B) to detect the blood sugar level of a PWD, and how a user can use a fast-acting insulin pen 6A to 6C to read data from the glucose sensor on either arm.

A cover 612 containing a first NFC antenna 691 and a second NFC antenna 693 is placed adjacent to the analyte sensor 631 . As shown in Figure 7A, in some embodiments, when the cap is placed adjacent to the analyte sensor 630 subcutaneously in the right arm of the PWD, 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 is placed adjacent to the analyte sensor 630 subcutaneously in the PWD right arm, the second NFC antenna 693 is closer to the subcutaneous sensor than the first NFC antenna 691. One NFC reader can be activated to read the first NFC antenna 691 and the second NFC antenna 693 alternately. 6A-6C, the first NFC antenna 691 and the second NFC antenna 693 may be located between the outer housing 601 and the inner housing 350 when the cover 612 is oriented relative to the analyte sensor 630, eg, in a first orientation (eg, in a first orientation). 7A), the first NFC antenna 691 receives the signal strength of at least one signal, eg, generated by the analyte sensor, at a higher signal strength than the second NFC antenna 693. And, when the cap 612 is oriented relative to the analyte sensor 630, for example, in a second orientation (eg, as shown in FIG. 7B ), the second NFC antenna 693 receives this at a higher signal strength than the first NFC antenna 691 The signal strength of at least one signal.

When the user holds the cap 612 to scan the glucose sensor 630 on his right arm "R" as shown in FIG. 7A, the user may hold the cap 612 in a first orientation. Alternatively, when the user holds the cap 612 to scan the glucose sensor 630 on his left arm "L" as shown in Figure 7B, the user may hold the cap 612 in the second orientation. In some implementations, the display information provided by the display 614 may be automatically rotated. This would allow the user to read the information "face up" without the inconvenience of presenting "upside-down" text on displays without auto-rotation capabilities. Therefore, the orientation of the information display will help the user to quickly identify whether the sensor is on his left arm or his right arm.

Instructions to select the orientation of the information display based on the orientation stored in the last scan, eg, until the glucose sensor was scanned on the opposite side, may be stored in memory and executed by the processor. This instruction may be implemented based on user input or based on a sensed condition, such as a change in the direction of gravity sensed by an onboard accelerometer. Alternatively, the information provided by the display 614 may not rotate automatically, so that the information remains stationary regardless of the orientation of the housing or which arm is being scanned.

Although the examples have been described with reference to one or more embodiments, changes and/or modifications may be made to the described examples without departing from the spirit and scope of the appended claims. Furthermore, although a particular feature of an example may have been disclosed with respect to only one of several embodiments, such feature may be combined with one or more other Feature combination.

Furthermore, to the extent that the terms "including, includes," "having, has, with," or variations thereof are used in the detailed description and claims, such terms are intended to be The same is inclusive. As used herein, phrases such as "one or more of" A, B, and C mean any of the following: A, B, or C alone; or a combination of the two, such as A and B, B and C and A and C; or a combination of three A, B and C.

Other embodiments will be apparent to those skilled in the art from consideration of this specification and practice of the descriptions disclosed herein. Both the specification and the examples are exemplary only, the proper scope and spirit of the embodiments being indicated by the following claims.

Claims (14)

1. A cover sleeve for a dosage device, the cover sleeve comprising:

a detector mechanism, the detector mechanism comprising:

an inner shell comprising

The first open end of the first tube is,

a second end opposite to the first end, an

A sidewall having an outer surface and an inner surface, the sidewall extending between the first end and the second end, an

A channel extending through a portion of the inner shell,

at least one switch;

a translatable shaft disposed at least partially in the passageway and comprising a dosing medical device engagement portion in a dosing medical device receiving cavity, a switch engagement portion, and a body extending between the dosing medical device receiving cavity and the switch engagement portion.

2. The cover sleeve of claim 1, 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 upon covering the dosing device into the inner housing.

3. The cover of claim 1, further comprising an outer housing, wherein the outer housing cooperates with an inner housing of a detector mechanism to define at least one inner chamber, the at least one switch being located in the inner chamber between the inner housing and the outer housing.

4. The cover sleeve of claim 3, further comprising a processor in communication with a switch in the inner chamber.

5. The cover sleeve of claim 4, further comprising a memory in communication with a processor in the inner chamber.

6. The cover sleeve of any one of the preceding claims, wherein the second end of the inner shell defines a needle receiving chamber.

7. The cover sleeve of claim 1, further comprising a limiter that limits travel of the translatable shaft.

8. The cover sleeve of claim 1, further comprising a spring, wherein the spring is positioned such that the spring remains compressed during the covering of the dosage form, the spring being positioned such that the spring returns to at least a lesser compressed state during the removal of the dosage form from the cover sleeve.

9. The cover sleeve of claim 1, wherein the translatable shaft is offset from and travels in a direction parallel to a central axis of the inner shell.

10. The cover sleeve of claim 1, further comprising a seal extending around a portion of the translatable shaft extending into the receiving chamber.

11. The cover sleeve of claim 10, wherein said seal comprises a hydrophobic lubricant in said channel along said translatable shaft.

12. The cover sleeve of claim 1, wherein the cover sleeve further comprises a proximity sensor.

13. The cover sleeve of claim 1, wherein the cover sleeve further comprises a display.

14. The cover sleeve of claim 3, further comprising a first NFC antenna and a second NFC antenna, the first NFC antenna being located between the outer shell and the first side of the inner shell, the second NFC antenna being located between the outer shell and the second side of the inner shell.

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