Annotation and event log information associated with an analyte sensor
阅读说明：本技术 与分析物传感器相关联的注释和事件日志信息 (Annotation and event log information associated with an analyte sensor ) 是由 A·库玛 J·戈德史密斯 于 2019-02-05 设计创作，主要内容包括：个人体内各种分析物的检测有时对于监视其健康状况会是至关重要的。与正常分析物水平的偏离能够指示多种生理状况。允许用户输入关于传感器用户的生活方式的数据并允许用户访问与分析物监视传感器关联的事件日志的改进的计算设备可以是有益的。(The detection of various analytes in an individual can sometimes be critical to monitoring their health condition. Deviations from normal analyte levels can be indicative of a variety of physiological conditions. An improved computing device that allows a user to enter data regarding a lifestyle of a sensor user and to access an event log associated with an analyte monitoring sensor may be beneficial.)
1. A method, comprising:
displaying, on a computing device, an analyte monitoring scan display window, the analyte monitoring scan display window including an add annotation button;
upon actuation of the add note button, transitioning to an input display window on the computing device that lists a limited number of user inputs associated with the sensor user's lifestyle events at a particular date and time;
selecting one or more of a limited number of user inputs, the input display window configured for entering information associated with the one or more selected user inputs;
receiving input of information associated with the one or more selected user inputs in an input display window; and
displaying a selectable symbol on an analyte monitoring daily display window on the computing device related to a summary of information input at the particular date and time,
wherein selection of the selectable symbol displays a pop-up display window on the computing device that displays a summary of the information input overlaid on the analyte monitoring daily display window.
2. The method of claim 1, wherein the computing device is communicatively coupled to an analyte monitoring sensor.
3. The method of claim 1, wherein the computing device is communicatively coupled to a glucose monitoring sensor.
4. The method of claim 1, wherein a summary of the input of information is linked to the analyte measurement at the specific date and time.
5. The method of claim 1, wherein the pop-up display window further comprises a selectable edit button.
6. The method of claim 1, wherein the limited number of user inputs are selected from the group consisting of food, fast acting insulin, exercise, commentary, and any combination thereof.
7. The method of claim 1, wherein the analyte monitoring scan display window displays a graphical representation of the analyte concentration.
8. The method of claim 1, wherein the analyte monitoring scan display window displays a graphical representation of glucose concentration.
9. The method of claim 1, wherein the analyte monitoring daily display window displays a graphical representation of analyte concentration.
10. The method of claim 1, wherein the analyte monitoring daily display window displays a graphical representation of glucose concentration.
11. The method of claim 1, further comprising closing a pop-up display window.
12. The method of claim 1, wherein the computing device is communicatively coupled to the analyte monitoring sensor and the limited number of user inputs associated with the lifestyle events of the sensor user are dynamic based on the analyte measurements from the analyte monitoring sensor.
13. A system, comprising:
a computing device having a display configured to display a plurality of display windows, the plurality of display windows comprising:
an analyte monitoring scan display window including an add annotation button;
an input display window listing a limited number of user inputs associated with lifestyle events of the sensor user at a particular date and time and configured for input of information associated with one or more selected user inputs;
an analyte monitoring daily display window configured to display selectable symbols related to a summary of the entry of information at the specific date and time; and
a pop-up display window displaying a summary of the input of information upon selection of a selectable symbol,
wherein the pop-up display window overlays the analyte monitoring daily display window;
and
an analyte monitoring sensor communicatively coupled to the computing device.
14. The system of claim 13, wherein the computing device is communicatively coupled to an analyte monitoring sensor.
15. The system of claim 13, wherein the computing device is communicatively coupled to a glucose monitoring sensor.
16. The system of claim 13, wherein the summary of the input of information is linked to the analyte measurement at the specific date and time.
17. The system of claim 13, wherein the pop-up display window further comprises a selectable edit button.
18. The system of claim 13, wherein the limited number of user inputs are selected from the group consisting of food, fast acting insulin, exercise, commentary, and any combination thereof.
19. The system of claim 13, wherein the analyte monitoring scan display window displays a graphical representation of the analyte concentration.
20. The system of claim 13, wherein the analyte monitoring daily display window displays a graphical representation of analyte concentration.
21. A computing device having a display configured to display a plurality of display windows, the plurality of display windows comprising:
an analyte monitoring scan display window including an add annotation button;
an input display window listing a limited number of user inputs associated with a lifestyle of a sensor user at a particular date and time and configured for input of information associated with one or more selected user inputs;
an analyte monitoring daily display window configured to display selectable symbols related to a summary of the entry of information at the specific date and time; and
a pop-up display window displaying a summary of the entry of information upon selection of the selectable symbol, wherein the pop-up display window overlays the analyte monitoring daily display window.
22. A method, comprising:
displaying a menu display window of the computing device, the menu display window listing a limited number of user-selectable buttons, including an event log button; and
upon selection of the event log button, transition to an event log display window of the computing device,
wherein the event log display window displays one or more events associated with the analyte monitoring sensor at a particular date and time.
23. The method of claim 22, wherein the analyte monitoring sensor is a glucose monitoring sensor.
24. The method of claim 22, wherein the limited number of user-selectable buttons including the event log button further comprises a button selected from the group consisting of: how to apply the sensor buttons, how to scan the sensor buttons, a user manual button, a terms of use button, a privacy statement button, and any combination thereof.
25. The method of claim 22, further comprising accessing a menu display window from a main menu display window.
26. The method of claim 22, further comprising accessing a menu display window from a main menu display window upon a user selecting a help button.
27. The method of claim 22, wherein the one or more events associated with an analyte monitoring sensor are selected from the group consisting of a scan error event, a sensor undercooling event, a new sensor discovery event, and any combination thereof.
28. The method of claim 22, wherein the event log display window further comprises a send troubleshooting data button.
29. The method of claim 22, wherein the event log display window further comprises a send troubleshooting data button, further comprising sending information associated with the event to customer service personnel upon selection of the send troubleshooting data button.
30. The method of claim 22, wherein an event log display window displays the one or more events associated with the analyte monitoring sensor and an accompanying description of the one or more events.
31. The method of claim 22, wherein an event log display window displays the one or more events associated with the analyte monitoring sensor and an accompanying icon or symbol.
32. The method of claim 22, further comprising a reference on an event log display window to a link of a user manual and its associated pages associated with the one or more events.
33. The method of claim 22, further comprising providing remedial instructions associated with the one or more events on an event log display window.
34. A system, comprising:
a computing device having a display configured to display a plurality of display windows, the plurality of display windows comprising:
a menu display window listing a limited number of user-selectable buttons, including an event log button,
an event log display window displaying one or more events associated with the analyte monitoring sensor at a particular date and time; and
an analyte monitoring sensor communicatively coupled to the analyte monitoring sensor.
35. The system of claim 34, wherein the analyte monitoring sensor is a glucose monitoring sensor.
36. The system of claim 34, wherein the limited number of user-selectable buttons including the event log button further comprises a button selected from the group consisting of: how to apply the sensor buttons, how to scan the sensor buttons, a user manual button, a terms of use button, a privacy statement button, and any combination thereof.
37. The system of claim 34, wherein the menu display window is accessed from a main menu display window.
38. The system of claim 34, wherein the menu display window is accessed from a main menu display window upon a user selecting a help button.
39. The system of claim 34, wherein the one or more events associated with an analyte monitoring sensor are selected from the group consisting of a scan error event, a sensor undercooling event, a new sensor discovery event, and any combination thereof.
40. The system of claim 34, wherein the event log display window further comprises a send troubleshooting data button.
41. The system of claim 34, wherein the event log display window further comprises a send troubleshooting data button, the send troubleshooting data button upon selection sending information associated with the event to a customer service person.
42. The system of claim 34, wherein an event log display window displays the one or more events associated with the analyte monitoring sensor and accompanying descriptions of the one or more events.
43. A computing device having a display configured to display a plurality of display windows, the plurality of display windows comprising:
a menu display window listing a limited number of user-selectable buttons, including an event log button,
an event log display window displaying one or more events associated with the analyte monitoring sensor at a particular date and time.
Background
The detection of various analytes in an individual is sometimes critical to monitoring their health condition. Deviations from normal analyte levels can be indicative of a variety of physiological conditions. For example, in diabetic patients, detection of abnormal glucose levels may be essential to maintain good health. By monitoring glucose levels with sufficient regularity, a diabetic may be able to take corrective action (e.g., by injecting insulin to lower glucose levels or by eating to raise glucose levels) before significant physiological damage occurs. It may similarly be desirable to monitor other analytes that suffer from physiological disorders in order to maintain good health.
Analyte monitoring of an individual may be performed periodically or continuously over a period of time. Periodic analyte monitoring may be performed by taking samples of a bodily fluid (such as blood) at set time intervals and performing in vitro analysis. Continuous analyte monitoring may be performed using one or more sensors that remain implanted within the tissue of the individual (such as dermally, subcutaneously, or intravenously implanted) so that analysis may be performed in vivo. The implanted sensor may continuously or occasionally collect analyte data, depending on the particular health needs of the individual.
An individual's analyte levels may be affected by various external stimuli associated with the individual's particular lifestyle. For example, if an individual has diabetes, the individual's food intake, exercise, or insulin injection can affect their glucose levels. Such lifestyle behavior may additionally affect other analyte levels. Moreover, other person-specific lifestyle events can affect analyte levels and/or it is valuable for a person to monitor to determine which lifestyle events affect their analyte levels.
Conventionally, analyte sensors provide feedback to a user based on information (e.g., data) collected by the sensor via a receiver, which can limit the user's ability to input lifestyle data, particularly data that can affect the output of the analyte sensor. Additionally, errors or events encountered during operation of the receiver and/or sensor may be inaccessible or difficult to access by a user and/or troubleshooting personnel (e.g., customer service personnel). As such, unstable analyte measurements can result without a known source or cause.
Drawings
The following drawings are included to illustrate certain aspects of the present disclosure and should not be taken as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, without departing from the scope of this disclosure.
Fig. 1A and 1B illustrate display screens of a computing device presenting an analyte monitoring scan display window, compatible with one or more embodiments of the present disclosure.
Fig. 2A-2C illustrate display screens of a computing device presenting an input display window, compatible with one or more embodiments of the present disclosure.
Fig. 3A-3J illustrate a series of input display window views depicting user interaction therewith, compatible with one or more embodiments of the present disclosure.
Fig. 4A-4J illustrate a series of input display window views depicting user interaction therewith, compatible with one or more embodiments of the present disclosure.
Fig. 5A and 5B illustrate display screens of a computing device presenting an analyte monitoring scan display window after user input, compatible with one or more embodiments of the present disclosure.
Fig. 6A-6D illustrate display screens of a computing device presenting an analyte monitoring daily display window compatible with one or more embodiments of the present disclosure.
Fig. 7A-7C illustrate display screens of a computing device presenting a pop-up display window, compatible with one or more embodiments of the present disclosure.
Fig. 8A and 8B illustrate display screens of a computing device presenting various user selections to generate a report, compatible with one or more embodiments of the present disclosure.
Fig. 9A and 9B illustrate display screens of a computing device presenting a limited number of user selections, including event log buttons, compatible with one or more embodiments of the present disclosure.
Fig. 10A and 10B illustrate display screens of a computing device presenting an event log display window, compatible with one or more embodiments of the present disclosure.
Fig. 11 is a block diagram depicting an example of an in vivo analyte monitoring system compatible with one or more embodiments of the present disclosure.
Fig. 12 is a block diagram depicting an example of a data processing unit compatible with one or more embodiments of the present disclosure.
Fig. 13 is a block diagram depicting an example of a display device compatible with one or more embodiments of the present disclosure.
Fig. 14 is a schematic diagram depicting an example of an analyte sensor compatible with one or more embodiments of the present disclosure.
Fig. 15A is a perspective view depicting an example embodiment of a skin-penetrating analyte sensor compatible with one or more embodiments of the present disclosure.
Fig. 15B is a cross-sectional view depicting a portion of the analyte sensor of fig. 15A compatible with one or more embodiments of the present disclosure.
Fig. 15C and 15D illustrate plan views of transcutaneous sensors compatible with one or more embodiments of the present disclosure.
Fig. 16-19 are cross-sectional views depicting examples of analyte sensors compatible with one or more embodiments of the present disclosure.
Fig. 20A is a cross-sectional view depicting an example of an analyte sensor compatible with one or more embodiments of the present disclosure.
Fig. 20B-20C are cross-sectional views depicting examples of analyte sensors viewed from line a-a of fig. 20A compatible with one or more embodiments of the present disclosure.
Fig. 21 is a conceptual diagram depicting an example of an analyte monitoring system compatible with one or more embodiments of the present disclosure.
Fig. 22 is a block diagram depicting an example of an on-body electronic device compatible with one or more embodiments of the present disclosure.
Fig. 23 is a block diagram depicting an example of a display device compatible with one or more embodiments of the present disclosure.
Fig. 24 is a flow diagram depicting an example of information exchange within an analyte monitoring system compatible with one or more embodiments of the present disclosure.
Fig. 25A and 25B illustrate display screens of a computing device presenting a launch display window, compatible with one or more embodiments of the present disclosure.
Detailed Description
The present disclosure relates generally to computing devices that allow a user to enter data regarding a lifestyle of a sensor user and to access event logs associated with an analyte monitoring sensor.
The computing device described in this disclosure allows for improved user interaction by allowing a user to customize input related to the lifestyle of a sensor user and easily and quickly access such information, particularly when it is related to specific analyte levels occurring within the sensor user's body. As used herein, with reference to the use of the computer device and display window of the present disclosure, the term "user" and grammatical variations thereof includes any individual manipulating a computing device and interacting with its display, including but not limited to a sensor user, a physician of the sensor user, a relative of the sensor user, and the like. As used herein, the term "sensor user" and grammatical variants thereof refers to an individual whose analyte level(s) is being measured or monitored. The computing devices described herein also allow for improved user interaction by allowing a user to access event information associated with the functionality of an analyte monitoring system that is communicatively coupled to the user so that the user can self-troubleshoot and/or send such information to customer service personnel for assistance.
As used herein, the term "computing device" and grammatical variations thereof refers to any type of device capable of processing and displaying information, including but not limited to a cellular telephone, a tablet computer, a receiver or data reader, a PDA, etc., whether the display is grayscale or color, and as further defined below with reference to display
In some embodiments, the computing device of the present application is preferably handheld, such as a touch screen cellular telephone. As used herein, the term "lifestyle" and grammatical variations thereof refers to a behavioral pattern of a sensor user, including, but not limited to, food intake, activity, exercise, sleep patterns, stress, and the like.
Computing devices associated with analyte monitoring sensors or other means for transmitting information to the computing device are often limited in availability and require multiple steps to access data or activate a particular function. As used herein, the term "analyte monitoring sensor," "analyte sensor," or simply "sensor," and grammatical variations thereof, refers to any in vitro or in vivo sensing device that can determine analyte levels of a body and transmit data therefrom that is associated with those analyte levels. In a preferred embodiment, the analyte monitoring sensor is an in-vivo sensor, such as a continuous analyte monitoring sensor. The sensor and sensing system are described in more detail below.
That is, conventional computing devices typically require the data and functionality to be divided into multiple layers and views, requiring the user to scroll through many windows or periodically switch views, which often wastes the user's time. When such computing devices are coupled with analyte monitoring sensors designed to manage disease or monitor health, the inconvenience of these multiple layers and views can negatively impact the user's experience, including total discouragement of use.
Conventional computing devices associated with analyte monitoring sensors typically do not allow a user to enter specific information about the lifestyle of the sensor user that can be easily entered and then easily accessed without the user having to browse through many views. For example, conventional computing devices may stratify various potential lifestyle inputs without allowing specific input or customization of information, such that data is limited (e.g., meals without associated carbohydrate amounts, exercises without intensity or duration, etc.) and yet cannot be viewed in a single display window. However, linking the lifestyle of the sensor user to a particular date and time of the analyte level measurement (e.g., concentration) is critical for controlling a particular disease (e.g., diabetes) or for the health of the sensor user. The multi-step nature of conventional computing devices may prevent users from linking sensor users' lifestyle events to their analyte levels, potentially leading to poor disease management or adverse health consequences.
Further, embodiments of the present disclosure allow a user to quickly access events related to the functionality of a paired analyte monitoring sensor, thereby allowing the user to determine how to troubleshoot the operation of the sensor. Conventional computing devices do not provide such functionality and therefore may result in failure to obtain accurate analyte level measurements, thereby also resulting in poor disease management or adverse health consequences.
Thus, embodiments described herein allow a user to access snapshot views (snap-shot views) of important sensor user lifestyle data and snapshot views of important events associated with the functionality of an analyte monitoring sensor. These snapshot views bring together data (if included) that would otherwise be different that is included in a conventional computing device. The aggregation of such data encourages the entry of lifestyle information and allows easy access to aggregated data associated with the lifestyle of the sensor user (e.g., by the sensor user, by a treating physician, by a relative (such as a parent or sibling), etc.). Thus, embodiments of the present disclosure improve the performance of the display and interactive interface associated with analyte sensor measurements, thereby improving the assessment and treatment of various analyte monitoring diseases.
Access to such a snapshot of lifestyle information in relation to specific analyte measurements (e.g., concentrations at specific dates and times) allows for quick and accurate adjustments to the user's health and/or determination of positive or negative lifestyle choices. For example, a user may determine whether exercise at a certain intensity is beneficial or detrimental to their analyte levels and alter their exercise regimen accordingly. The user can target (pinpoint) specific food groups that are beneficial or detrimental to their analyte levels and adjust the dietary decisions accordingly.
Access to a snapshot of event log information that is relevant to a particular analyte measurement of the present disclosure (e.g., concentration at a particular date and time) allows a user to troubleshoot potentially erroneous analyte measurements that may result in unnecessary or potentially harmful therapeutic behavior (e.g., if the sensor is too cold to make an accurate measurement, the user will know not to immediately inject insulin or eat certain foods to change their glucose level). Moreover, the combination of the event log of the present disclosure and the lifestyle information of the sensor user will further allow the user to more accurately understand their analyte measurements to make appropriate treatment decisions.
Although fig. 1A-10B describe the computing device of the present disclosure with reference to a glucose analyte monitoring sensor, it should be understood that the computing device of the present disclosure is suitable for use with any other type of analyte monitoring sensor (e.g., a lactate monitoring sensor) without departing from the scope of the present disclosure.
Annotation and input of information corresponding to lifestyle of sensor user
Referring now to fig. 1A and 1B, two exemplary embodiments of a display of a computing device displaying an analyte monitoring scan display window, or more specifically, in these embodiments, a my glucose display window, are shown. As used herein, "analyte monitoring scan display window" or simply "scan display window" and grammatical variations thereof refer to a display window of a computing device having a display screen configured to show at least one characteristic (e.g., date and time) of a measured analyte associated with a particular analyte scanning event, but which may include additional analyte measurements. The scan display window may be distinct from an analyte monitoring daily display window of the computing device, which will be discussed in detail herein below.
As shown in fig. 1A and 1B, the scanning display window may include an icon in the upper right corner of the display window that, when selected, allows a user to scan an analyte monitoring sensor communicatively coupled to a computing device having a display screen displaying the scanning display window. For example, in one embodiment, actuating or selecting a "scan" icon (or any other selectable symbol or button prompting to scan, e.g., "ready to scan" or "please scan," etc.) may automatically gather data from the computing devices described herein. In some embodiments, after the computing device is placed in proximity to the analyte monitoring sensor, a connection (e.g., a Near Field Communication (NFC) connection) may be established and data from the sensor may be transmitted to the computing device. In certain embodiments, a scanning display window or other display window may be automatically activated to display the sensor user's analyte level (e.g., display a graphical representation, actual analyte level or concentration, other derived analyte levels (e.g., A1c), etc.) for use. That is, one or more of the display screens of the computing device may automatically (e.g., as a notification) alert the user to scan data (e.g., the display window of fig. 1A or 1B may automatically appear on the computing device). The display may display any or all of the analyte level trend arrows, trend analyte level messages, current analyte readings, etc., as described below.
In some embodiments, if the computing device is idle (e.g., the cellular telephone is in sleep mode), a notification banner may appear to remind the user (e.g., the sensor user) to initiate scanning the display window and/or scan the analyte monitoring sensor. That is, the computing device may be configured to prompt the user to scan the sensor user for analyte levels at particular times, which may be pre-configured or configured by the user, including the sensor user. For example, if the computing device is a cellular telephone, then even if it is locked or otherwise in a "sleep" mode (and any variations thereof), a scan display window will be displayed and/or another form of prompt will appear without departing from the scope of this disclosure. That is, if the computing device has a sleep mode, the embodiments described herein allow the computing device to communicate to the user the need to scan the sensor user for analyte levels, allowing the user to easily obtain analyte levels (e.g., glucose) without actually activating or removing the computing device from the sleep mode. In some embodiments, upon placing a computing device described herein (e.g., a cell phone, tablet, PDA, health monitor or pedometer, etc.) in proximity to an analyte monitoring system, the computing device may automatically scan for analyte measurements. That is, in embodiments of the present disclosure, physical scanning may or may not be required.
Thus, the scan display window displays a particular just past scan (e.g., a scan that occurred immediately or shortly before the scan display window was displayed, shown as 137mg/dL in fig. 1A), but may further be used by the user to initiate a new scan (e.g., a back-to-back scan from a previous scan, or a subsequent scan after any period of time has elapsed). For example, a user may wish to perform a continuous scan immediately or shortly after a previous scan to test the accuracy of the coupled sensor.
The scanning the display window may further comprise one or more of: a clock (digital or analog, as applicable throughout all display windows herein), a current analyte level concentration based on a last scan of the analyte monitoring sensor, a graphical representation of the analyte level over time, and a target range of encoding of the analyte level (e.g., the shaded region between 100 and 140mg/dL in fig. 1A and 1B). As shown in fig. 1A and 1B, the graphical representation of analyte levels over time is depicted with time on the x-axis and analyte levels in milligrams per deciliter (mg/dL) on the y-axis. Other units (e.g., using a 24 hour clock, using millimoles per liter (mmol/L) for analyte levels, etc.) or unit intervals may define the graphical representation without departing from the scope of the present disclosure, so long as the analyte level is linked to a particular date and time.
In some embodiments, as shown in fig. 1A and 1B, the scanning display window may inform the sensor user whether their analyte level is within a particular target range by displaying an analyte level trend arrow and/or a trending analyte level message. The target range may be defined by the computing device or by a user (e.g., a sensor user), and accordingly may be adjustable in some embodiments to allow personalization.
The trend arrows may include: a diagonal right arrow pointing upward to indicate that the analyte level is rising; a vertical arrow pointing up to indicate that the analyte level is rising rapidly; an arrow horizontal to the right or left (preferably to the right) to indicate that the analyte level is stable or slowly changing; a diagonal arrow pointing downward to indicate that the analyte level is falling; and/or a vertical arrow pointing downward to indicate that the analyte level is dropping rapidly. The trend analyte level message may include language stating that the analyte level is above the high threshold, between the target range and the high threshold, within the target range, below the low threshold, or between the target range and the low threshold. Alternatively, or in addition to the trend arrow and/or trend message, color coding may also be color coded, such as orange, yellow, green, yellow, and red, respectively, to indicate that the analyte level is above the high threshold, between the target range and the high threshold, within the target range, below the low threshold, or between the target range and the low threshold. In embodiments of the present disclosure, the trend arrows, trend messages, and color coding may be displayed in the scanning display window simultaneously or alternately. Thus, one or more means of communicating the trend of the sensor user's analyte levels may be employed in order to suit a particular individual (e.g., a color blind user may find color coding to be non-helpful and thus may rely on one or both of the trend arrows and/or messages). As shown in fig. 1A and 1B, the glucose analyte level is within the target range, showing a trend arrow to the right of the level, the message being each of a "glucose in range" trend message and a color coding of green.
Thus, once the analyte level of the sensor user corresponding to the measurement provided by the analyte monitoring sensor is scanned, the scan display window of the computing device(s) described herein having a display screen may be accessed. The scanning display window may also be a display window that accesses other functions, including accessing user input buttons associated with the lifestyle of the sensor user at a certain date and time. As used herein, the term "button" and grammatical variations thereof refer to an element of a computing device having multiple displays that, when actuated (e.g., pressed or contacted), causes some alteration in a particular display window without the limitations of size, style, texture, tactile sensation, shape, etc. (e.g., implemented in a computer screen, hyperlink, keyboard, slider, scroll bar, etc.). It is understood that various components of the scan display window may be changed without departing from the scope of this disclosure, including but not limited to terms, color coding, arrow directions, proportions, sizes, arrangements, and/or icons (iconology).
The scanning display window of the present disclosure may include functionality for quickly accessing a limited number of user input buttons associated with the sensor user's lifestyle at a particular date and time. As depicted in fig. 1A and 1B, access to the user input buttons may be in the form of buttons having pen or pencil shaped icons. In some embodiments, the pen or pencil icon may be depicted as pointing generally downward and to the left, although other configurations are within the scope of the present disclosure. The icon may be separate or have accompanying text, such as "add comment" shown in FIG. 1A. As used herein, the term "add comment button" and grammatical variations thereof refers to a button that is part of a display window (e.g., a scanning display window) of a computing device having multiple display windows that allows user input regarding the lifestyle of a sensor user and is not limited to any particular term or icon. For example, other text or symbols, such as adding a diary, entering notes, notepad icons, etc., may be used alone or in combination without departing from the scope of the present disclosure.
The add note button may include an icon and any accompanying text that the user may select (e.g., via a touch screen in this embodiment) and transition to an input display window having a limited number of user input buttons associated with the sensor user's lifestyle at a particular date and time. It should be understood that any other icon and/or text design or terminology that may prompt a user to understand that selecting a button associated therewith will result in access to an input display window may be used in accordance with the present disclosure without departing from the scope hereof.
Thus, upon selection of the add note button (see fig. 1A and 1B), a computer device having the display screen of the present disclosure can transition to an input display window. Referring now to fig. 2A and 2B, two exemplary embodiments of a display of a computing device are shown that displays an input display window, or more specifically, an "add comment" display window in these embodiments. As used herein, "input display window" and grammatical variations thereof refer to a display window of a computing device having a display configured to allow a user to input information about a lifestyle of a sensor user, whether in free form or according to specific prompts.
The input display window of the present disclosure may include a list of a limited number of user input buttons associated with the lifestyle of the sensor user at a particular date and time. These user input buttons may be designed to track certain known influencing factors of the analyte being measured by an analyte monitoring sensor communicatively coupled to the computing device. As shown in fig. 2A-2C, such a limited number of user input buttons may include, but are not limited to, food, fast acting insulin, long acting insulin, exercise, comments, and any combination thereof. Various user input buttons may be associated with various icons, as shown in fig. 2A and 2B. It should be understood that such icons need not be present, and that the particular style of any icon present is not limited to the styles shown in fig. 2A and 2B, so long as they represent a particular user input button.
In some embodiments, the user input may be dynamic based on previously gathered information from previously input information. For example, in some embodiments, the user input buttons that appear are associated with the most commonly used functions (such as meals or insulin boluses). In other embodiments, the computing device may be configured such that the display is predictive. For example, if the sensor user's analyte level is high, the computing device may automatically display or provide a user input button to prompt the user (e.g., the sensor user) to enter data related to the sensor user's lifestyle, such as a recent meal or insulin injection. That is, the computing device may be configured to detect certain spikes in analyte levels and prompt the user to enter data related to the lifestyle of the sensor user. For example, if glucose is soaring, a "food" user input button may appear because the sensor user is just eating, or if glucose levels suddenly drop, a "quick-acting" or "long-acting" user input button may automatically appear because the sensor user is just administering a bolus of insulin. Thus, the user may be prompted to enter an input based on the dynamic readings of the analyte monitoring sensor.
The user input buttons of the input display window may be selected by selecting the associated icon, a description of the user input button, and/or a selectable symbol (e.g., a checkbox). For example, as shown in fig. 2A and 2B, the user input buttons of "food", "quick-acting insulin", "long-acting insulin", and "exercise" may be selected using selectable symbols in the form of check boxes, and the input button of "comment" may be selected upon selection of the word "comment" or "comment" icon (see fig. 2A). As described herein, any variation that is optional is contemplated in the teachings of the present disclosure without departing from the scope thereof.
The input display window may also include a number of additional information for viewing or manipulation by a user of the computing device, including, but not limited to, current analyte level concentrations based on a last scan of the analyte monitoring sensor, trend arrows and/or messages, color coding, specific date and time, selectable cancel buttons, and/or selectable accept (or "complete") buttons. Other features of the input display window may include selectable scan buttons or icons, selectable main menu buttons or icons, selectable set buttons or icons, and/or selectable return buttons or icons, such as those shown in fig. 2B, without departing from the scope of the present disclosure. It is understood that various components of the input display window, including but not limited to terms, color coding, arrow directions, proportions, sizes, arrangements, and/or icons, may be changed without departing from the scope of the present disclosure, so long as there are a limited number of user input buttons for user input regarding the lifestyle of the sensor user.
Referring now to fig. 3A-3J, a series of views of an input display window showing user interaction therewith is illustrated, in accordance with one or more embodiments of the present disclosure. Within the input display window (e.g., fig. 2A and 2B), the user may interact with a limited number of user input buttons displayed therein. When a limited number of user input buttons are selected for use in entering certain information about the sensor user's lifestyle, any icons associated therewith may be highlighted or otherwise emphasized (e.g., by color, bold, etc.) to illustrate to the user that the input is in progress or is in progress. As described below, each user input regarding the lifestyle of the sensor user is linked to the user input information via the electronic device of the computing device and accepts a specific date and time of the input (e.g., selecting a "done" button). In doing so, the user may track the lifestyle choices of the sensor user that are associated with the particular analyte level being measured or monitored by the analyte monitoring sensor. Moreover, as described below, a computing device having a display according to embodiments described herein directly associates lifestyle information of a sensor user with analyte monitoring data on a scanning display and further allows direct access to the lifestyle information therefrom.
As shown in fig. 3A-3C, the user may select the "food" user input button by selecting a selectable symbol (e.g., a check box) and then prompt the user for additional information within the input display window. In this embodiment, the user is prompted to select the appropriate meal for entry, which may be in the form of a drop down menu, a scrolling menu, or other selectable menu type. Meal choices may include, but are not limited to, "breakfast," "lunch," "dinner," and "snacks," without being constrained by any particular order. As shown in fig. 3C, once an appropriate meal (e.g., "lunch") is selected, the user may enter specific information about the meal, which may be related to the particular analyte level being measured or monitored by the analyte monitoring sensor. As shown in fig. 3C, the user may enter a particular number of grams of carbohydrates associated with the sensor user's meal, which may be entered, for example, via a keyboard or touch screen, via voice-activated text, and/or another recordable or selectable menu. Other specific information may also be prompted for entry by the user, so long as such information is associated with the analyte level of interest, such as a specific type of sugar for glucose monitoring, without departing from the scope of the present disclosure.
Once a single user input is entered regarding the sensor user's lifestyle, the user may accept the entry and input to the input display window that the user has completed his entry (e.g., by selecting a "complete" button). Alternatively, the user may wish to continue to enter additional information about the sensor user's lifestyle. Fig. 3D and 3E depict a user who has entered a food input, in turn, selecting a selectable symbol for entering rapid-acting insulin, where thereafter the user may be prompted to enter specific units of rapid-acting insulin to be ingested by the user at that particular date and time. Although not shown, the user may similarly select a selectable symbol for entering a dose (e.g., in units) of long-acting insulin. As shown in fig. 3E, once additional input regarding the sensor user's lifestyle is entered, any previous entries remain visible and editable to the user to ensure that the full picture of the sensor user's lifestyle at that particular date and time is accurately captured. If the user has entered multiple items of information about the sensor user's lifestyle, the input display window may include a scroll bar (e.g., on the right or left side of the display window) to allow the user to access information beyond the size of the display of the computing device (see fig. 4H-4J, which show the scroll bar on the right side of the display window).
Fig. 3F and 3J depict the user further selecting a selectable symbol for entering an exercise, after which the user may be prompted to select a particular energy intensity level. For example, the "select intensity" prompt shown in fig. 3F may provide a selectable menu (e.g., a drop-down menu, a scrollable menu, etc.) that allows the user to select a particular intensity, such as the "low intensity", "medium intensity", and "high intensity" options shown in fig. 3G. Once a particular exercise intensity is selected by the user, the user may be prompted to enter a duration of the exercise, as shown in fig. 3H. As shown in fig. 3H, a selectable menu for entering a duration may be selected by the user, and upon selection, the display of the computing device may transition to a duration display window (see fig. 3I).
As used herein, "duration display window" and grammatical variations thereof refer to a display window of a computing device having a display configured to allow a user to select or enter a particular duration. As shown in fig. 3I, the duration display window may include a selectable menu for entering hour and minute duration information, depicted as a scrolling menu in fig. 3I, but which may be any form of selectable menu, including allowing the user to enter (via typing, text or voice activated entry, etc.) hour and minute duration information. In some embodiments, the duration display window also allows for entry of other time intervals, such as seconds, without departing from the scope of the present disclosure. The duration display may also include other features and functions, such as a title of the duration display window (e.g., "edit time"), a selectable cancel button, and/or a selectable accept (or "complete") button, without departing from the scope of the present disclosure. Upon accepting the entered time, the display of the computing device transitions back to the input display window.
In other embodiments, rather than transitioning to the duration display window, a selectable menu for entering hour and minute duration information may appear directly on the input display window (see fig. 4H and 4I) once the user selects a selectable symbol for entering an exercise and thereafter selects a particular energy intensity level. In such embodiments, information is directly entered into the input display window and viewable along with additional input information entered by the user that is relevant to the lifestyle of the sensor user.
Although not shown, the user may additionally enter comments into the input display window, which may be via a keyboard or touch screen, via voice activated text, or selectable menus with specific pre-coded narration. These pre-coded narratives may be included as part of the computing device or may be user-configurable. For example, such narration may relate to stress, sleep patterns, or other common lifestyle events associated with the life of the sensor user. These comments, when included, may, but need not, be visible with other input information in the input display (and in the pop-up display windows of fig. 7A and 7B) without departing from the scope of this disclosure.
Fig. 4A-4J illustrate a series of views of an input display window showing user interaction therewith according to one or more embodiments of the present disclosure, according to one or more embodiments described herein. Fig. 4A-4J illustrate embodiments that differ in aesthetics and certain features, but are substantially similar to the embodiments described above with reference to fig. 3A-3J, and thus will not be discussed in detail herein.
Fig. 3J and 4J represent user-completed input displays that allow a user to view all input information and accept entered information (e.g., by selecting a "complete" button) at a single location, according to one or more embodiments of the present disclosure. It should be understood that any or all of the user input buttons may have been selected, and that the information input regarding the lifestyle of the sensor user includes a comment input without departing from the scope of this disclosure.
Once input information associated with the sensor user's lifestyle is accepted, the display of the computing device may again transition to a scanning display window and associate particular input data with the particular date and time the input was accepted, and the particular input may be displayed as a selectable icon (see fig. 5A). As shown in fig. 5A and 5B, the scan display window may be updated to display the time at which the user accepts input information and to associate such time with a particular analyte level. Alternatively, if data is entered within a limited duration (e.g., less than 3 minutes or 5 minutes) after a scan, the user input information may be automatically associated with the particular date and time of the last scan, or the user may enter a particular date and time for association, without departing from the scope of the present disclosure.
Visually, this time can be thought of as a clock or the amount of time that has elapsed since the last scan and/or user input. The scan display window may display the last scan as a hatched line in a graphical representation of the analyte level over a relatively short period of time (e.g., 8 to 12 hours), may include a selectable icon or other selectable symbol to indicate that user information is associated with the analyte level or the particular scan at a particular time, and/or may include a selectable edit button to allow the user to enter additional comments and/or edit comments that have been entered (e.g., "edit comments" of fig. 5A or pencil or pen icons of fig. 5B). As shown, icons or other symbols may be used to indicate that user information has been entered for a particular date and time, and may be edited by selecting a selectable edit button or by directly selecting an icon or symbol, without departing from the scope of the present disclosure.
The analyte monitoring daily display window of the computing device may be accessed by transitioning from the analyte monitoring scan display window, such as hitting a return arrow icon shown in the upper left corner of fig. 5A and 5B, or by other ways of transitioning the display window. As used herein, the term "analyte monitoring daily display window" or simply "daily display window" and grammatical variations thereof refers to a display window of a computing device having a display configured to show a plurality of measured analyte levels (e.g., concentrations), each measured analyte level associated with a particular date and time and lasting at least 24 hours. The daily display window may be the primary display window of the computing device described herein. Representative embodiments of daily display windows in accordance with one or more embodiments of the present disclosure are shown in fig. 6A-6D.
As shown in FIGS. 6A-6D, characteristics of the daily display window may include, but are not limited to, an icon banner indicating a countdown (e.g., represented by a color-changing or shape-changing graphic (such as a bar) in units of days and hours) of sensor life of the associated analyte monitoring sensor, a graphical representation of analyte levels over a period of at least 24 hours, a target range of encoding of analyte levels (e.g., a shaded area between 100 and 140mg/dL in FIGS. 6A and 6B), a selectable scan button or icon (e.g., an upper right icon in FIG. 6A or a bell icon in FIG. 6B), a selectable main menu button or icon (e.g., an upper left hamburger icon in FIGS. 6A and 6B), a selectable set button or icon (e.g., an upper right vertical dot icon in FIG. 6B), An indication of the time period represented by the daily display window (e.g., "24 hours past"), an indication of when the new sensor is ready to be used (e.g., an indication of its remaining warm-up time or the time the sensor will be ready) (which includes an icon ("i") indicating that such information is being displayed), and/or various data related to the analyte level during the measurement time period (e.g., "time in target," "last scan," "average," etc.). In some embodiments, selectable setting buttons or icons may be integrated such that information about such settings and as described below is located within a selectable main menu (i.e., rather than having two separate menus).
In addition to these features, the daily display window may also display one or more selectable symbols related to the user-entered data regarding the lifestyle of the sensor user as described above, as shown in fig. 6A and 6B. The selectable symbols may be positioned along a timeline of the graphical representation such that their positions are related to the date and time that the particular input was recorded. In doing so, input information regarding the sensor user's lifestyle can be correlated to specific analyte levels, allowing the sensor user to make informed decisions about future lifestyle choices and their impact on specific analyte levels. As shown in fig. 6A and 6B, the dates may be relative displays with reference to the current date (e.g., "wednesday/thursday" in fig. 6A and "saturday/sunday" in fig. 6B) and/or the actual dates may be displayed. Other features may be displayed on the daily display window of the computing device described herein without departing from the scope of the present disclosure. It should also be understood that various components of the daily display window may be changed without departing from the scope of the present disclosure, including but not limited to terms, color coding, arrow directions, proportions, sizes, arrangements, and/or icons.
The selectable symbol (or icon) of the daily display window may be any signal that indicates a summary of the information entered by the user. In some embodiments, the selectable symbols of the daily display window may be a single symbol (e.g., the runner symbol in fig. 6A), two or more overlapping symbols (e.g., the apple and syringe symbol in fig. 6B), or a stacked symbol showing a number representing the number of inputs for a particular date and time (e.g., a stacked symbol showing the number "3" in fig. 6A or the number "4" in fig. 6B). Any other symbols may be suitable without departing from the scope of the present disclosure, as long as they represent user input information, and may or may not be related to the symbols (if any) displayed in the input display window.
The user may select one of the selectable icons from the daily display window to display a pop-up display window that overlays a summary of the input information on the daily display window, as shown in the embodiments of fig. 7A through 7C. As shown, the pop-up display window may include a summary of the entered time and input information entered by the user, which may vary depending on what limited user input buttons the user selects to select and provide input (see, e.g., fig. 2A and 2B above). The pop-up display window may include any summary indicating information input by the user, including but not limited to associated icons, descriptions of user input buttons, and input data provided by the user, as shown in fig. 7A-7C. In addition, the pop-up display window may include a selectable edit icon (e.g., a pencil or pen icon, or any other form of selectable edit button) located at a selectable location within the pop-up display window to allow the user to again access the input display window and alter its input, for example, if such alteration is necessary to ensure accuracy of the input. Additionally, in some embodiments, an optional accept button (e.g., "OK") may be included, wherein upon selection of the accept button, the pop-up display window is closed (e.g., not displayed or no longer displayed) to again reveal the daily display window in its entirety. Alternatively or additionally, the user may select a portion of the pop-up display window (i.e., not a selectable edit icon button or an accept button) to not display the pop-up display window and again expose the daily display window in its entirety, or the user may select a portion of the daily display window (i.e., not another selectable button) to not display the pop-up display window and again expose the daily display window in its entirety.
Other features may be displayed on the pop-up display window of the computing device described herein without departing from the scope of the present disclosure, so long as they contain a summary of the input information at a particular date and time related to the lifestyle of the sensor user. It should also be understood that the various components of the daily display window may be changed without departing from the scope of the present disclosure, including but not limited to terms, color coding, arrow directions, proportions, sizes, arrangements, and/or icons.
Event logs associated with analyte monitoring sensors
As described above, a computing device of the present disclosure that includes multiple displays may include event logs associated with analyte monitoring sensors at specific dates and times. Thus, the computing device may track the functionality of the analyte monitoring sensor, allow a user to access an event log of the analyte monitoring sensor for monitoring or troubleshooting, and allow the user to transmit event log data to a customer service representative that can assist the user in troubleshooting the sensor. Fig. 8A-10B illustrate one or more embodiments of a computing device described herein that allows a user to access and transmit event logs of communicatively coupled analyte monitoring sensors. It is understood that various features of fig. 8A-10B may be changed without departing from the scope of the present disclosure, including but not limited to terms, color coding, proportions, sizes, arrangements, and/or icons.
Referring now to fig. 8A and 8B, displays of a computing device of the present disclosure are illustrated displaying various user-selectable buttons accessible from a selectable main menu button or icon or a selectable setup button or icon, in accordance with one or more embodiments of the present disclosure. The user-selectable buttons may be generic buttons for navigating multiple displays of the computing device, which in some embodiments may be accessed via icons or menu symbols (e.g., hamburger icons or vertical dot icons). Thus, the universal user-selectable buttons allow a user to select to access various displays associated with the computing device and/or an analyte monitoring sensor communicatively coupled to the computing device. Any suitable user-selectable buttons may be included in the embodiments shown in fig. 9A and 9B, including but not limited to a home page display window, a logbook display window, a reminder display window, a report display window associated with various usage modes (e.g., daily mode, time in target, low or high analyte (e.g., glucose) events, average analyte (e.g., glucose) levels, daily graphics, estimated analyte levels or levels associated with analytes (e.g., A1c), and/or sensor usage), a setup display window, a shared display window, a related display window, an account display window, and/or a help display window, without departing from the scope of the present disclosure. Without limitation, any one or more icons may or may not be associated with user-selectable buttons.
Upon selecting one of the general user-selectable buttons from the main menu or setup menu (collectively referred to herein as the "main menu"), the user may be directed to a new menu display window that shows a list of a limited number of additional user-selectable buttons, including event log buttons. As shown in fig. 9A and 9B, the generic button may be a "help" button that transitions to a menu display window having a limited number of user-selectable buttons (including an "event log" button). In the non-limiting embodiment shown in fig. 9A and 9B, other user-selectable buttons displayed on the menu display window may include, but are not limited to, how to apply the sensor, how to scan the sensor, an analyte (e.g., glucose) reading, a user manual, terms of use, and/or privacy statements. It should be understood that while the event log button is depicted in fig. 9A and 9B as part of the help menu display window, the location of the event log button may be accessed via any of the other general user-selectable buttons described above without departing from the scope of this disclosure. The menu display window (shown as a help menu display window in fig. 9A and 9B) may also include selectable scan buttons or icons, a main menu or set menu icon, and/or a back button, among other potential features.
The user may select the event log button and be directed to the event log of the computing device of the present disclosure. That is, once the user selects the event log button, the computing device transitions to the event log display window. As used herein, the term "event log display window" and grammatical variations thereof refers to a display window of a computing device having a display configured to show at least one event associated with an analyte monitoring sensor at a particular date and time. Fig. 10A and 10B illustrate an embodiment of an event log display window in accordance with one or more embodiments of the present disclosure. As shown, each event may, but need not, be accompanied by an event association number (e.g., "375" in FIG. 10A and "335" and "336" in FIG. 10B), an event title, an event description, an event icon or symbol, and/or the date and time of the event occurrence, among other potential features.
In some embodiments, the event log records events related to errors in scanning the analyte monitoring sensor, events related to the temperature of the sensor (e.g., the sensor may be too cold to accurately provide analyte measurements), and/or sensing by a new sensor. Any suitable event associated with the functionality of the sensor may additionally be included in the event log without departing from the scope of the present disclosure. In some embodiments, the event log prompts the user and/or sensor user to take a particular action, such as using a new sensor sensed by the computing device to begin analyte measurement or monitoring. In other embodiments, the event log may also display a link or page number of the user manual describing the event (e.g., possibly an error event) and the associated remediation steps. The link may be a link to a user manual stored on the device or a website containing information about the error. If multiple event log entries are received by the computing device, the event log display window may include a scroll bar (e.g., on the right or left side of the window) to allow the user to access information beyond the size of the display of the computing device, as shown in fig. 10A and 10B.
While event logs may be useful to users of computing devices and associated sensors, the event log display window may also allow users to send event log data to customer service personnel, such as manufacturers of sensors experiencing events. The event log data may be transmitted to customer service personnel using a user-selectable button, such as a "send troubleshooting data button" as shown in figure 10B. As used herein, the term "send troubleshooting data button" and grammatical variations thereof refers to a user-selectable button that is capable of transmitting event log information associated with an analyte monitoring sensor regardless of the terminology, size, shape, etc. of the particular button. Alternatively or additionally, the send troubleshooting data button may transmit data to customer service personnel associated with the computing device as well as the manufacturer of the sensor. In other embodiments, upon receiving the data event log, confirmation of receipt of the message may be sent back to the user in the form of a banner, icon, or other symbol. The message may contain further information regarding remedial actions that the customer service personnel may take, such as alerting the user that the sensor is malfunctioning, suggesting that the user stop using the sensor, alerting the user that a new replacement sensor is being sent, or a combination thereof.
Referring now to fig. 25A and 25B, various display screens of a computing device presenting a launch display window are illustrated, compatible with one or more embodiments of the present disclosure. The launch display window may include various elements, as shown, including a brand name (e.g., FreeStyle)TMLibreLinkTM) An analyte monitoring device (e.g., a glucose sensor) communicably coupled to the computing device, one or more brand icons (e.g., butterflies), a button that allows access to a plurality of additional displays, a selectable main menu button or icon, and/or a selectable setup button or icon.
Exemplary embodiments of in vivo analyte monitoring systems
Referring now to fig. 11, an
Also shown in fig. 11 is an optional
According to embodiments of the present disclosure, the computing device having multiple display screens described herein may be either or both of the
In the embodiment of
In a multi-component environment, each component may be configured to be uniquely identified by one or more of the other components in the system so that communication conflicts between the various components within
In some embodiments,
In some embodiments, the
In operation, in some embodiments, the
With continued reference to FIG. 11, the
The
In some embodiments, the
Fig. 12 is a block diagram depicting an embodiment of the
As can be seen from the embodiment of fig. 12, the analyte sensor 101 (fig. 11) includes four contacts, three of which are electrodes: a working electrode (W)210, a reference electrode (R)212, and a counter electrode (C)213, each of which is operatively coupled to the
Fig. 13 is a block diagram of an embodiment of a receiver/monitor unit (such as primary display device 104) of the analyte monitoring system shown in fig. 11. The
In some embodiments, the
In further embodiments, the
Fig. 14 schematically illustrates an embodiment of an
The
Fig. 15A shows a perspective view of an embodiment of an analyte sensor 500, the analyte sensor 500 having a first portion (which in this embodiment can be characterized as a primary portion) positionable above a skin surface 510 and a second portion (which in this embodiment can be characterized as a secondary portion) comprising an insertion tip 530, the insertion tip 530 being positionable below the skin surface (e.g., penetrating the skin and into a subcutaneous space 520) and in contact with a biological fluid, such as interstitial fluid, of a user. The contact portion 511 of the working electrode, the contact portion 512 of the reference electrode, and the contact portion 513 of the counter electrode are positioned on a first portion of the sensor 500 above the skin surface 510. Working
Fig. 15B shows a cross-sectional view of a portion of the sensor 500 of fig. 15A. The
A first insulating layer 505 (such as a first dielectric layer in some embodiments) is disposed or laminated over at least a portion of the first
A second insulating layer 506 (such as a second dielectric layer in some embodiments) may be disposed or laminated over at least a portion of the second
In some embodiments, some or all of the
Referring now to fig. 15C and 15D, another embodiment of an analyte monitoring sensor according to one or more embodiments of the present disclosure is shown and represents a variation of the sensor 500 of fig. 15A. As shown in fig. 15C and 15D, a transcutaneous sensor 520 according to one or more embodiments of the present disclosure includes a substrate 521, a first working electrode 522 on the substrate 521, a second working electrode 523 on the substrate 521, and a sensor membrane 524 covering the substrate 421 and the first and second working electrodes 522, 523. Although in the illustrated embodiment, first working electrode 522, second working electrode 523 are positioned on opposite sides of substrate 511, in one or more embodiments first working electrode 522, second working electrode 523 can be positioned in any other suitable location on substrate 521. For example, in one or more embodiments, first working electrode 522, second working electrode 523 can be on the same side of substrate 521. The substrate 521 includes a distal end 525 configured for insertion into the skin of a user and a proximal end 526 opposite the distal end 525 configured for connection to various electrical connections for transmitting the output signal of the transcutaneous sensor 520. The distal end 525 may have a pointed or rounded tip, or other shaped tip that facilitates insertion of the sensor 520 into the skin of the user.
With continued reference to the embodiment shown in fig. 1B, first working electrode 522 may include a first active sensing region 527 and second working electrode 523 may include a second active sensing region 528. Although not shown, first active sensing region 527 of first working electrode 522 is configured to convert an analyte signal into a first output signal (e.g., a current output signal), and second active sensing region 528 of second working electrode 523 is configured to convert an analyte signal into a second output signal (e.g., a current output signal). The output signals of the first and second active sensing regions 527, 528 correspond to a physiological condition of the user, such as for example a blood glucose level of the user. Furthermore, in the illustrated embodiment, first active sensing region 527 of first working electrode 522 has a first area and second active sensing region 528 of second working electrode 523 has a second area, which may be the same or different.
First active sensing region 527 of first working electrode 522 is longitudinally offset along substrate 521 from second active sensing region 528 of second working electrode 523. In the illustrated embodiment, the distal-most end of the first active sensing region 527 is spaced apart from the distal end 525 of the substrate 521 by a first distance d1, and the distal-most end of the second active sensing region 528 is spaced apart from the distal end 525 of the substrate 521 by a second distance d2 that is greater than the first distance d1 (i.e., the distal-most end of the second active sensing region 528 is spaced apart from the distal end 525 of the substrate 521 by a greater distance than the distal-most end of the first active sensing region 527). Further, in the illustrated embodiment, the proximal-most ends of the first active sensing regions 527 are spaced apart from the distal end 525 of the substrate by a third distance d3, and the proximal-most ends of the second active sensing regions 528 are spaced apart from the distal end 525 of the substrate 521 by a fourth distance d4 equal to or substantially equal to the third distance d3 (i.e., the proximal-most ends of the first and second active sensing regions 527, 528 are spaced apart from the distal end 525 of the substrate 521 by the same or substantially the same distance). Thus, in the illustrated embodiment, the longitudinally central portion 529 of the first active sensing region 527 is offset from the longitudinally central portion 530 of the second active sensing region 528. In one or more embodiments, the proximal-most end of the first active sensing region 527 may not be aligned with the proximal-most end of the second active sensing region 528.
Furthermore, in the illustrated embodiment, the first area of the first active sensing region 527 is greater than the second area of the second active sensing region 528. In the illustrated embodiment, the first and second active sensing regions 527, 528 each comprise a series of discrete sensing spots 531, 532 (e.g., dots), respectively. In the illustrated embodiment, the size of each discrete sensing spot 531 in the first active sensing area 527 is equal or substantially equal to the size of each discrete sensing spot 532 in the second active sensing area 528. In a preferred embodiment, the number of discrete sensing spots 531 in the first active sensing region 527 is larger than the number of discrete spots 532 in the second active sensing region 528; however, in other embodiments, the discrete sensing spots 531, 532 may be equal in number or the discrete sensing spot 531 may be fewer than the discrete sensing spot 532 without departing from the scope of the present disclosure. Although there are six (6) uniformly sized discrete sensing spots 531 in the first active sensing region 527 and three (3) uniformly sized discrete sensing spots 532 in the second active sensing region 528 in the illustrated embodiment, the first and second active sensing regions 527, 528 may include any other suitable number of discrete sensing spots in one or more embodiments without departing from the scope of the present disclosure. Furthermore, in one or more embodiments, the first active sensing region 527 and/or the second active sensing region 528 can comprise a continuous strip (e.g., an elongated oval) rather than a series of discrete sensing spots. Further, in one or more embodiments, the first area of the first active sensing region 527 can be equal or substantially equal to the second area of the second active sensing region 528.
Further, in one or more embodiments, transcutaneous sensor 520 may include a reference electrode, a counter electrode, or a counter-reference electrode. In the illustrated embodiment, transcutaneous sensor 520 includes a counter electrode 533 and a reference electrode 534. In the illustrated embodiment, the reference electrode 534 and the counter electrode 533 are on opposite sides of the substrate 521, but may be on the same side of the substrate 521 without departing from the scope of the present disclosure. Further, in the illustrated embodiment, counter electrode 533 is separated from first working electrode 522 by a first dielectric insulator layer 535, and reference electrode 534 is separated from second working electrode 523 by a second dielectric insulator layer 536.
Embodiments of a dual-sided stacked sensor configuration that may be used in conjunction with the present disclosure are described herein with reference to fig. 16-18. Fig. 16 shows a cross-sectional view of a distal portion of a dual-sided analyte sensor 600. The analyte sensor 600 includes an at least substantially planar insulating base substrate 601, such as an at least substantially planar dielectric base substrate, having a first conductive layer 602 covering substantially the entire first surface area (e.g., top surface area) of the insulating substrate 601, e.g., extending substantially the entire length of the substrate to the distal edge and across the entire width of the substrate from side edge to side edge. The second conductive layer 603 covers substantially the entire second surface (e.g., bottom side) of the insulating base substrate 601. However, one or both of the conductive layers may terminate proximal of the distal edge and/or may have a width that is less than the width of the insulating substrate 601, where the width ends at a selected distance from the side edges of the substrate, which may be equidistant or different relative to each side edge.
One of the first or second conductive layers (e.g., first conductive layer 602) may be configured to include a working electrode of the sensor. The opposing conductive layer (here, second conductive layer 603) can be configured to include a reference electrode and/or a counter electrode. Where conductive layer 603 serves as either a reference electrode or a counter electrode but not both, a third electrode may optionally be provided on either the surface area of the proximal portion of the sensor (not shown), on a separate substrate, or as an additional conductive layer positioned above or below conductive layer 602 or 603 and separated from those layers by one or more insulating layers. For example, in some embodiments, where analyte sensor 600 is configured to be partially implanted, conductive layer 603 may be configured to include a reference electrode, and a third electrode (not shown) present only on the non-implanted proximal portion of the sensor may be configured to include a counter electrode of the sensor.
A first insulating layer 604 covers at least a portion of the conductive layer 602 and a second insulating layer 605 covers at least a portion of the conductive layer 603. In one embodiment, at least one of first insulating layer 604 and second insulating layer 605 does not extend to the distal end of analyte sensor 600, leaving exposed areas of the one or more conductive layers.
Fig. 17 shows a cross-sectional view of a distal portion of a dual-
In the embodiment of fig. 17,
In the embodiment of fig. 17,
A first insulating
In an alternative embodiment, as shown in fig. 18, the analyte sensor 800 has an insulating layer 804 on the working electrode side of an insulating base substrate 801, which insulating layer 804 may be disposed before the sensing region 802A, whereby the insulating layer 804 has at least two portions spaced apart from each other on the conductive layer 802. Then, a sensing region 802A is provided in the space between the two portions. For example, where multiple sensing components or layers are desired, more than two spaced apart portions may be provided. The bottom insulating layer 805 has a length terminating near the auxiliary conductive layer 803A on the bottom main conductive layer 803. As described above, additional conductive and dielectric layers may be provided on either or both sides of the sensor.
Although fig. 16-18 are depicted or discussed herein as being able to position the working and reference electrodes in a particular layered configuration, it should be noted that the relative positioning of these layers may be modified. For example, the counter electrode layer may be disposed on one side of an insulating base substrate, while the working and reference electrode layers are disposed in a stacked configuration on the opposite side of the insulating base substrate. Further, by adjusting the number of conductive layers and insulating layers, a different number of electrodes than depicted in fig. 16-18 may be provided. For example, a three (3) or four (4) electrode sensor may be provided.
One or more membranes may be included in, on, or near the sensor, which may serve as an analyte flux modulating layer and/or one or more of an interference rejection layer and/or a biocompatible layer (e.g., as one or more of the outermost layer (s)) as discussed in more detail below. The membranes of the present disclosure can take many forms. For example, the film may include only one component or a plurality of components. The membrane may have a spherical shape, such as if the membrane covers the terminal region (e.g., sides and terminal tip) of the sensor. The membrane may have a substantially planar structure and may be characterized as a layer. The planar membrane may be smooth or may have small surface (topological) variations. The membrane may also be configured in other non-planar configurations. For example, the membrane may have a cylindrical or partial cylindrical shape, a hemispherical or other partial spherical shape, an irregular shape, or other rounded or curved shape.
In some embodiments, as shown in fig. 17,
In other sensor embodiments, as shown in fig. 18, a single homogenous film 806 may be coated over the entire sensor surface area or at least over both sides of the distal tail portion. Note that in order to coat the distal and side edges of the sensor, it may be necessary to apply the membrane material after singulation (singulation) of the sensor precursors (precorsors). In some embodiments, the analyte sensor is dip coated after singulation to apply one or more membranes. Alternatively, the analyte sensor may be slot-die coated, wherein each side of the analyte sensor is coated separately.
Fig. 19 illustrates a cross-sectional view of a distal portion of an example dual-
In the embodiment of fig. 19,
In the embodiment of FIG. 19, the
In the embodiment shown in fig. 19, the
As shown in fig. 19, the
When manufacturing layered sensors, it may be desirable to reduce the overall sensor width with a relatively thin insulating layer. For example, referring to fig. 19, insulating
One way to address this potential problem is to provide one of the conductive layers (e.g., electrode layers) at least partially as a relatively narrow electrode, including, for example, a relatively narrow conductive trace, such that during the singulation process, the sensor is cut on either side of the narrow electrode, such that one electrode is cut without cutting through the narrow electrode.
For example, referring to fig. 20A-20C, a
With continued reference to fig. 20A and 20C, the
As shown in fig. 20B, first
An embodiment of a sensing region may be described as the region schematically shown as 508 in fig. 115B and as 908 in fig. 9. As described above, the sensing region may be provided as a single sensing component, as shown as 508 in fig. 15B, as 702A in fig. 17, and as 802A in fig. 18, or as a plurality of sensing components, as 908 in fig. 19. Multiple sensing components or sensing "spots" are described in U.S. patent application publication No.2012/0150005, which is incorporated herein by reference in its entirety.
As used herein, the term "sensing region" and grammatical variations thereof is a broad term and can be described as an active chemical region of an analyte monitoring sensor or biosensor. The sensing region may take a variety of forms. The sensing region may include only one component or multiple components (e.g., such as
The sensing region formulation, which may include a glucose transduction agent, may include, for example, a redox mediator such as, for example, hydrogen peroxide or a transition metal complex such as a ruthenium-containing complex or an osmium-containing complex, and an analyte-responsive enzyme such as, for example, a glucose-responsive enzyme (e.g., glucose oxidase, glucose dehydrogenase, etc.) or a lactate-responsive enzyme (e.g., lactate oxidase), among other components. In some embodiments, the sensing region comprises glucose oxidase. The sensing region may also include other optional components, such as, for example, polymers and bifunctional short-chain epoxide cross-linkers (such as polyethylene glycol (PEG)).
In some embodiments, the sensing region formulation includes a protein switch component that allows for the detection of any desired analyte. The use of a protein switch allows a selected redox mediator, such as, for example, hydrogen peroxide or a transition metal complex, such as a ruthenium-containing complex or an osmium-containing complex, to be coupled to a selected enzyme, such as, for example, a glucose-responsive enzyme (e.g., glucose oxidase, glucose dehydrogenase, etc.) or a lactate-responsive enzyme (e.g., lactate oxidase), to provide a qualitative or quantitative detection platform for any desired analyte. The selected enzyme is coupled (e.g., covalently linked) to a selective analyte binding ligand (e.g., a peptide, antibody fragment, other immunoglobulin, aptamer (aptamer), etc.), such that binding of the analyte present in the analyzed sample to the analyte binding ligand alters (e.g., inhibits or enhances) the activity of the selected enzyme. Thus, the presence of analyte in the sample being analyzed increases or decreases with a detectable product of the enzyme activity (e.g., a change in the redox state of the reaction solution), as desired. Although certain examples of selected enzyme components of protein switches are described herein, it is understood that any enzyme or enzymatically functional portion thereof that catalyzes the production of a product that can be detected (e.g., electrochemically detected) may be employed. Such systems can be used to detect a wide variety of analytes, including but not limited to proteins and peptides, lipids, carbohydrates, metabolites, hormones, synthetic molecules (e.g., drugs) or metabolites thereof, antibodies, pathogen components, nucleic acids, toxins, minerals, and the like. The analyte binding portion of the protein switch may be derived from a protein that binds to an analyte. Such proteins that bind analytes may include, for example, antibodies, receptors (including full-length, fragment, and single-chain receptors), and artificially-bound proteins made using scaffold or display techniques. Alternatively, when the analyte to be detected is or is derived from a receptor, the analyte binding moiety may be derived from a ligand.
The protein switch may be derived from a protein having binding affinity for the analyte, which may allow the protein switch to detect the analyte at physiological levels. The protein switch may be made of an analyte binding protein having the desired kinetics for binding a physiological level of analyte. Specific exemplary protein switch components for multiple analytes and methods of designing, making, enhancing, and optimizing protein switch components (e.g., using libraries of fusion proteins and high-throughput screening techniques) are described in U.S. provisional patent application serial No. 62/468,878 (filed on 8/2017) and U.S. provisional patent application serial No. 62/544,364 (filed on 11/2017), both of which are incorporated by reference in their entirety and for all purposes.
In some embodiments, two or more different protein switching systems responsive to two or more different analytes are employed in a single sensor. In some such embodiments, different analytes generate the same reporter signal in the same region, such that the presence of any analyte produces a detectable result. In other embodiments, different analytes generate different or distinguishable signals, such that each analyte can be detected and analyzed separately (e.g., generating a different signal or generating the same signal in different regions (e.g., different layers of a multi-layer sensor)).
In some cases, the analyte-responsive enzyme is distributed throughout the sensing region. For example, the analyte-responsive enzyme may be uniformly distributed throughout the sensing region such that the concentration of the analyte-responsive enzyme is substantially the same throughout the sensing region. In some cases, the sensing region may have a homogeneous distribution of analyte-responsive enzyme. In some embodiments, the redox mediator is distributed throughout the sensing region. For example, the redox mediator may be uniformly distributed throughout the sensing region such that the concentration of the redox mediator is substantially the same throughout the sensing region. In some cases, the sensing region can have a homogeneous distribution of redox mediator. In some embodiments, as described above, both the analyte-responsive enzyme and the redox mediator are uniformly distributed throughout the sensing region.
As described above, the analyte sensor may include an analyte-responsive enzyme to provide a sensing component or sensing zone. Some analytes (such as oxygen) may be directly electro-oxidized or electro-reduced on the sensor and more specifically at least on the working electrode of the sensor. Other analytes, such as glucose and lactate, require the presence of at least one electron transfer agent and/or at least one catalyst to facilitate the electrooxidation or electroreduction of the analyte. The catalyst may also be used for analytes (such as oxygen) that can be directly electro-oxidized or electro-reduced at the working electrode. For these analytes, each working electrode includes a sensing region on or near the surface of the working electrode (see, e.g.,
The sensing region may include one or more components configured to facilitate electrochemical oxidation or reduction of the analyte. The sensing region can include, for example, a catalyst for catalyzing a reaction of the analyte and producing a response at the working electrode, an electron transfer agent for transferring electrons between the analyte and the working electrode (or other component), or both.
A variety of different sensing region configurations may be used in embodiments of the present disclosure. The sensing region is often positioned in contact with or near an electrode (e.g., a working electrode). In some embodiments, the sensing region is deposited on the conductive material of the working electrode. The sensing region may extend beyond the conductive material of the working electrode. In some cases, the sensing region may also extend over other electrodes, for example over the counter and/or reference electrodes (or if a counter/reference electrode is provided).
The sensing region in direct contact with the working electrode may contain an electron transfer agent for transferring electrons directly or indirectly between the analyte and the working electrode, and/or a catalyst that facilitates a reaction of the analyte. For example, a glucose, lactate, or oxygen electrode having a sensing region containing a catalyst may be formed, including glucose oxidase, glucose dehydrogenase, lactate oxidase, or laccase (laccase), respectively, and an electron transfer agent that promotes electrooxidation of glucose, lactate, or oxygen, respectively. As described above, a protein switch may be employed that provides an indirect mechanism for detecting an analyte of interest by converting the binding of the analyte to a binding partner into a change in the activity of an enzyme.
In other embodiments, the sensing region is not deposited directly on the working electrode. Alternatively, the sensing region 508 (fig. 15) may be spaced apart from the working electrode, for example, and separated from the working electrode by a separation layer, for example. The separation layer may comprise one or more membranes or films or physical distances. In addition to separating the working electrode from the sensing region, the separation layer may also act as a mass transport limiting layer (mass transport limiting layer) and/or an interference cancellation layer and/or a biocompatible layer.
In some embodiments including more than one working electrode, one or more of the working electrodes may not have a corresponding sensing region, or may have a sensing region that does not contain one or more components (e.g., an electron transfer agent and/or a catalyst) required to electrolyze the analyte. Thus, the signal at this working electrode may correspond to a background signal that may be removed from the analyte signal obtained from one or more other working electrodes associated with a fully functional sensing region by, for example, subtracting the signal.
In some embodiments, the sensing region comprises one or more electron transfer agents. Electron transfer agents that can be employed are electrically reducible and oxidizable ions or molecules with redox potentials hundreds of millivolts higher or lower than that of Standard Calomel Electrodes (SCEs). The electron transfer agent may be organic, organometallic or inorganic. Examples of organic redox species are quinones and species having a quinone structure in their oxidized state, such as nile blue and indoxyl. Examples of organometallic redox species are metallocenes, including ferrocenes. Examples of inorganic redox species are hexacyanoferrate (III), ruthenium hexahexanol, and the like. Additional examples include those described in U.S. patent nos. 6,736,957, 7,501,053, and 7,754,093, the disclosures of each of which are incorporated herein by reference in their entirety.
In some embodiments, the electron transfer agent has a structure or charge that prevents or substantially reduces diffusion loss of the electron transfer agent during the period of time that the sample is being analyzed. For example, electron transfer agents include, but are not limited to, redox species bonded to, for example, a polymer, which may in turn be disposed on or near the working electrode. The bond between the redox species and the polymer may be covalent, synergistic or ionic. While any organic, organometallic, or inorganic redox species can be bonded to the polymer and used as an electron transfer agent, in some embodiments, the redox species is a transition metal compound or complex, for example, osmium, ruthenium, iron, and cobalt compounds or complexes. It will be appreciated that many of the redox species described as being used with the polymer component may also be used without the polymer component.
Embodiments of the polymeric electron transfer agent can comprise a redox species covalently bonded in the polymeric composition. An example of this type of mediator is poly (vinylferrocene). Another type of electron transfer agent comprises an ionically bonded redox species. This type of mediator may include a charged polymer coupled to an oppositely charged redox species. Examples of this type of mediator include negatively charged polymers coupled to positively charged redox species such as osmium or ruthenium polypyridine cations. Another example of an ionically-bonded mediator is a positively-charged polymer, including quaternized poly (4-vinylpyridine) or poly (1-vinylimidazole), which is coupled to a negatively-charged redox species (such as ferricyanide or ferrocyanide). In other embodiments, the electron transfer agent comprises a redox species that is synergistically bonded to the polymer. For example, the mediator may be formed by the coordination of an osmium or cobalt 2,2' -bipyridyl complex with poly (1-vinylimidazole) or poly (4-vinylpyridine).
Suitable electron transfer agents are osmium transition metal complexes having one or more ligands, each ligand having a nitrogen-containing heterocycle, such as 2,2' -bipyridine, 1, 10-phenanthroline, 1-methyl, 2-pyridyldiimidazole, or derivatives thereof. The electron transfer agent may also have one or more ligands covalently bonded in the polymer, each ligand having at least one nitrogen-containing heterocycle, such as pyridine, imidazole, or derivatives thereof. One example of an electron transfer agent includes (a) a polymer or copolymer having pyridine or imidazole functionality, and (b) an osmium cation complexed with two ligands, each ligand comprising 2,2' -bipyridine, 1, 10-phenanthroline, or a derivative thereof, the two ligands not necessarily being the same. Some derivatives of 2,2 '-bipyridine useful for complexation with osmium cations include, but are not limited to, 4' -dimethyl-2, 2 '-bipyridine and mono-, di-, and polyalkoxy-2, 2' -bipyridines, including 4,4 '-dimethoxy-2, 2' -bipyridine. Derivatives of 1, 10-phenanthroline for complexation with the osmium cation include, but are not limited to, 4, 7-dimethyl-1, 10-phenanthroline and mono-, di-and polyalkoxy-1, 10-phenanthrolines, such as 4, 7-dimethoxy-1, 10-phenanthroline. Polymers useful for complexing with osmium cations include, but are not limited to, polymers and copolymers of poly (1-vinylimidazole) (referred to as "PVI") and poly (4-vinylpyridine) (referred to as "PVP"). Suitable copolymer substituents for poly (1-vinylimidazole) include acrylonitrile, acrylamide, and substituted or quaternized N-vinylimidazoles, such as electron transfer agents having osmium complexed with a polymer or copolymer of poly (1-vinylimidazole).
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