CN119258334A

CN119258334A - Liquid delivery cap with alignment confirmation

Info

Publication number: CN119258334A
Application number: CN202411552314.2A
Authority: CN
Inventors: A·J·利文斯顿; G·克罗索尔; J·M·约翰逊
Original assignee: Patients Pending Ltd
Current assignee: Patients Pending Ltd
Priority date: 2019-06-20
Filing date: 2020-06-19
Publication date: 2025-01-07
Also published as: AU2020298273A1; CA3144322A1; CN114206415B; US20220305210A1; WO2020255085A1; CN114206415A; EP3986508A1

Abstract

A cover device (100) for a liquid delivery device (200), when the liquid delivery device is inserted into the cover device and rotated relative to the cover device, the cover device operates to detect the position of the liquid delivery device relative to the cover device. The cover device includes one or more sensors (120), and the one or more sensors are configured to detect the position of the liquid delivery device relative to the cover device. The position of the liquid delivery device can be used to determine whether the liquid delivery device is inserted and arranged in an appropriate axial and/or radial position relative to the cover device, so that the cover device can accurately detect the state of the liquid delivery device.

Description

Liquid delivery cap with alignment verification

The application is a divisional application of patent application with application number 202080056655.4, application number 'liquid delivery cap with alignment confirmation', which is the application of the year 2020, 6 and 19.

Technical Field

Devices, systems, and methods are described herein in connection with a cap device of a liquid delivery device, e.g., configured to detect a plunger of the liquid delivery device.

Background

Liquid delivery systems are commonly used to deliver measured amounts of a drug to a patient. For example, pen injector delivery devices have been used to deliver measured amounts of medication and include a delivery end that passes through a closure for storage between uses, and a plunger that is movable within a reservoir and that can dispense measured doses. The cap device may protect the delivery end from damage during storage and may be used to display information to the user, such as the duration of time since the cap was last removed during previous use of the injection device or information about the contents of the delivery device.

Disclosure of Invention

Some embodiments described herein include cap devices, systems, and methods configured to detect a position (e.g., a radial orientation or an axial position) of a liquid delivery device relative to the cap device, a status of the liquid delivery device, and/or output dose information based at least in part on the detected status. For example, a liquid delivery system may include a liquid delivery device having a reservoir and a movable plunger that causes liquid to flow from the reservoir, and a cover device configured to cover at least a delivery end of the liquid delivery device. The cap device includes one or more sensors configured to detect a position of the liquid delivery device relative to the cap device and/or to detect a condition of the liquid delivery device. For example, the position of the liquid delivery device may be used to determine whether the liquid delivery device is inserted and arranged at a suitable axial and/or radial position with respect to the cap device, such that the cap device may accurately detect the state of the liquid delivery device. Alternatively or additionally, the detected position information may be used during a subsequent determination of the status of the liquid delivery device. The status of the liquid delivery device may include the position of the plunger, which may be used to determine the volume of liquid within the reservoir, dose information (e.g., previously delivered dose volume), and/or other information related to the liquid delivery device and its operation. In an exemplary embodiment, detecting proper axial and/or radial alignment facilitates detecting accurate and reliable liquid volume and dose information.

In some examples, the cap device is configured to axially receive at least a portion of the liquid delivery device in the cap device such that the liquid delivery device is at least partially rotatable relative to the cap device. In some embodiments, the cap device is configured to axially receive the liquid delivery device in a plurality of possible orientations and provide feedback, such as mechanical (e.g., click/click feel), visual and/or audible feedback, to indicate that the liquid delivery device is inserted into a predetermined axial position. Alternatively or additionally, the cap device is configured to detect whether the liquid delivery device is axially inserted into the cap device (e.g., engaged with the cap device) and/or to detect an axially aligned position of the liquid delivery device relative to the cap device. Further, in some embodiments, the cap device may be configured to detect a radial position of the liquid delivery device and determine whether the liquid delivery device is rotated to a predetermined radial position (e.g., a radial alignment position) relative to the cap device (e.g., when a user rotates the liquid delivery device relative to the cap device). For example, the cover device monitors changes in sensor signals generated by the one or more sensors and detects a predetermined characteristic of the liquid delivery device based on the changes in sensor signals when the liquid delivery device has been rotated to a predetermined orientation. Additionally, the cap device may be configured to provide feedback, such as mechanical (e.g., click/click feel), visual and/or audible feedback, to ensure that the liquid delivery device is rotated to a predetermined radial position and/or that the liquid delivery device is not rotated beyond a predetermined radial position. The radial alignment position may be a single radial position or a plurality of radial positions, each providing a suitable line of sight for accurate plunger detection. Similarly, the axially aligned position may include one or more axial positions that allow the liquid delivery device to rotate to the radially aligned position, and/or one or more axial positions at which the liquid delivery device engages the cap device.

Some example cap devices may include one or more mechanical feedback structures, such as user-perceivable snaps, and other mechanical interactions, that generate physical feedback (e.g., a clicking feel) when the liquid delivery device is engaged with the cap device in an axial direction and/or when the liquid delivery device is in a predetermined radial position.

Some example cap devices may provide one or more outputs related to the relative positions of the cap device and the liquid delivery device. For example, the cap device comprises one or more output devices that output information indicative of the axial and/or radial position of the liquid delivery device relative to the cap device. In addition, the cap device may present information to prompt and/or assist a user in inserting and aligning the liquid delivery device into the cap device. The information may be presented in various forms, such as visual, audible, and/or tactile forms. In some embodiments, the output device includes a display device configured to display symbols (e.g., signs, text, letters, numbers, colors, animations, etc.) that indicate the position of the liquid delivery device relative to the body, e.g., whether the liquid delivery device is in an axially aligned position and/or a radially aligned position. Such a symbological display may be used to facilitate the correct insertion and arrangement of the liquid delivery device in the cap device by the user for accurate and reliable measurement.

In some embodiments, the cover device optionally includes a body and a sensor bracket movably located within the body. At least one of the sensors configured to detect the radial position of the liquid delivery device relative to the cover device may be mounted on the sensor carriage. Alternatively or additionally, one or more of the sensors may be fixedly positioned relative to the body of the cap device, the sensor being configured to detect a radial position of the liquid delivery device relative to the cap device.

The sensor is operable to output a sensor signal. The sensor signals may vary based on characteristics of the liquid delivery device encountered by the one or more sensors. For example, the sensor signal may be different depending on the axial and/or radial positioning of the liquid delivery device relative to the cap device. Further, the sensor signal may vary based on the plunger or liquid, transparent or opaque features, numbers/letters, graduation markings, etc. within the reservoir. In some embodiments, the sensor carriage is movable between the first and second positions without user operation, or is movable by positioning the cover device on the liquid delivery device without additional user operation.

Some example cap devices may facilitate placement of the liquid delivery device in an axial and/or radial position relative to the cap device, allowing for accurate and repeatable detection of the plunger position of the liquid delivery device. For example, the plunger position may be used to determine the volume of a previously delivered dose or the volume remaining in the reservoir. Alternatively or additionally, some embodiments facilitate accurate and repeatable measurements by reducing manual manipulation during detection. For example, the sensor carriage may be movable between the first and second positions when the liquid delivery device is at least partially received in the cap device, and no additional manual operation by the user is required other than the operation of engaging the liquid delivery device with the cap device.

Some example cap devices may determine that the liquid delivery device is not radially aligned with the cap device at a first time and then determine that the liquid delivery device is radially aligned with the cap device at a second, later time. The radial alignment at the second time allows the cap device to obtain an accurate measurement of the state of the liquid delivery device (e.g., plunger position, amount of liquid remaining in the liquid delivery device, etc.), while the radial misalignment may result in an inaccurate measurement of the state of the liquid delivery device. For example, after axially inserting the cap device over the liquid delivery device, the user may ignore placing the cap device and the liquid delivery device in a predetermined radial alignment. If the user subsequently removes the cap device from the liquid delivery device (e.g., for a subsequent liquid injection) before the cap device and the liquid delivery device are not in a predetermined radial alignment, then at a later time, subsequently replaces the cap device onto the liquid delivery device in a predetermined radial alignment, the cap may determine an approximate state of the liquid delivery device (e.g., plunger position, amount of liquid remaining in the liquid delivery device, etc.) at the previous and subsequent times. The cap device may determine an approximate state of the liquid delivery device at a previous time (when the cap device is in radial misalignment) based on, for example, the user's glycemic response, the user's historical dose, the user's therapeutic parameters, or any other information that may approximate conditions.

Particular embodiments described herein include a cover device for a liquid delivery device. The cover device may include a body and a first sensor. The body defines a cavity configured to at least partially receive the liquid delivery device. The first sensor is configured to output a sensor signal indicative of a radially aligned position of the liquid delivery device relative to the body when the liquid delivery device is at least partially received within the cavity of the body.

In some embodiments, the cover device optionally includes one or more of the following features.

The cap device may include a second sensor configured to output a sensor signal indicative of a plunger of the liquid delivery device, and a processor configured to determine that the liquid delivery device is not in a radially aligned position at a first time, determine that the liquid delivery device is in a radially aligned position at a second time that is later than the first time, determine a position of the plunger at the second time using the second sensor, and calculate an approximate position of the plunger at the first time based at least in part on the position of the plunger at the second time. The approximate position of the plunger at the first time may also be based on at least one of a user's glycemic response, a user's historical dose, and a user's therapeutic parameters.

The cover device may comprise a processor configured to detect a radial alignment position of the liquid delivery device based on the sensor signal of the first sensor.

The first sensor may be configured to output a sensor signal indicative of the radial alignment position when the first sensor is located at a predetermined axial position along the liquid delivery device.

The cover means may comprise a sensor carriage movable between a first position and a second position within the cavity when the liquid delivery means is in a fixed position relative to the cavity. The first sensor may be located on the sensor carriage. Alternatively, the first sensor may be fixedly mounted to the body.

The cover device may comprise a second sensor. The second sensor may be located on the sensor carriage. The second sensor may be configured to output a sensor signal indicative of a plunger of the liquid delivery device when the sensor carriage moves between the first position and the second position.

The cover device may include a motor configured to move the sensor carriage between the first position and the second position.

The processor may be configured to determine a state associated with the liquid delivery device based on the sensor signals of the first sensor and the sensor signals of the second sensor.

The processor may be configured to record a first time at which the liquid delivery device is axially received in the cavity of the body and a second time at which the liquid delivery device is moved to the radially aligned position. The processor may determine a state associated with the liquid delivery device based on the sensor signal of the first sensor, the sensor signal of the second sensor, the first time, and the second time.

The first sensor may include a first optical transmitter and a first optical receiver. An optical path may be defined between the first optical transmitter and the first optical receiver. The first sensor is operable to detect a physical characteristic of the liquid delivery device by outputting a sensor signal indicative of the physical characteristic.

The second sensor may include a second optical transmitter and a second optical receiver. An optical path may be defined between the second optical transmitter and the second optical receiver. The second sensor is operable to detect a physical characteristic of the liquid delivery device by outputting a sensor signal indicative of the physical characteristic.

The cover device may include a position sensor configured to detect an axial position of the sensor carrier within the body. The physical feature of the liquid delivery device may include a plunger of the liquid delivery device. The processor is operable to detect a plunger of the liquid delivery device based on the change in the sensor signal and to determine a corresponding position of the plunger based on the sensor signal output by the position sensor.

The status associated with the liquid delivery device may include at least one of a volume of a dose delivered by the liquid delivery device, a total volume of liquid remaining within the liquid delivery device, a number of doses remaining within the liquid delivery device, a duration remaining before the liquid delivery device is emptied, and a time of a previous dose, a time elapsed since a last dose.

The cap means may comprise axial position means configured to engage a liquid delivery means axially inserted into the cavity of the body. The axial position device may generate a first mechanical feedback when the liquid delivery device is engaged with the axial position device.

The axial position device may include a sensor configured to generate a sensor signal indicative of engagement of the liquid delivery device with the axial position device.

The body of the cap device is configured to axially receive at least a portion of the liquid delivery device in the cavity. The liquid delivery device is at least partially rotatable relative to the body when at least a portion of the liquid delivery device is within the cavity.

The sensor bracket may mount a first sensor. The motor is operable to move the sensor carriage to a predetermined axial position where the first sensor is arranged to detect a radially aligned position of the liquid delivery device.

The cap device may comprise a radial holding structure configured to generate a second mechanical feedback when a radial alignment position of the liquid delivery device is detected.

The cover device may include a display device configured to output information indicative of a position of the liquid delivery device relative to the body.

The cap device may comprise a sleeve configured to receive at least a portion of the liquid delivery device. The sensor carriage may be configured to move along the outside of the sleeve.

Particular embodiments described herein include a method for operating a cap device of a liquid delivery device. The method includes detecting a radial position of the liquid delivery device relative to a body of the cap device when the liquid delivery device is at least partially within the cap device, and outputting information related to the radial position of the liquid delivery device.

In some embodiments, the method optionally includes one or more of the following features.

The method may comprise detecting engagement of the liquid delivery device with the cap device prior to detecting the radial position. The liquid delivery device is rotatable relative to the body of the cap device.

The information may indicate whether the radial position of the liquid delivery device is moved to a predetermined radial alignment position.

The method may further include determining that the liquid delivery device is not radially aligned with the body of the cap device at a first time, determining that the liquid delivery device is radially aligned with the body of the cap device at a second time that is later than the first time, determining a position of the plunger at the second time, and calculating an approximate position of the plunger at the first time based at least in part on the position of the plunger at the second time. The approximate position of the plunger at the first time may also be based on at least one of a user's glycemic response, a user's historical dose, and a user's therapeutic parameters.

The method may include generating a first mechanical feedback when the liquid delivery device is moved to a predetermined axially aligned position.

The method may include generating a second mechanical feedback when the radial position of the liquid delivery device moves to a predetermined radial alignment position.

The method may include activating the cap device when the liquid delivery device is moved to a predetermined axially aligned position.

The method may include detecting a first time at which the liquid delivery device is axially engaged in the cavity of the body, detecting a second time at which the liquid delivery device is in a predetermined radially aligned position, detecting a feature associated with the liquid delivery device using the sensor, and determining a status associated with the liquid delivery device based on the feature, the first time, and the second time.

Detecting the radial position of the liquid delivery device may include receiving a sensor signal from a first sensor indicative of a radial alignment position of the liquid delivery device relative to the body of the cap device.

The method may include driving a sensor carriage including a first sensor to a predetermined axial position within the cover device. The first sensor may be configured to generate a sensor signal indicative of the radial alignment position when the sensor carriage is arranged at the predetermined axial position.

The method may comprise driving a sensor carriage comprising a second sensor between a first position and a second position within the body of the cap device upon detecting the radial position of the liquid delivery device. The method may further include detecting a physical characteristic of the liquid delivery device as the sensor carriage moves between the first position and the second position.

Detecting a physical characteristic of the liquid delivery device may include receiving a sensor signal from a second sensor indicative of a plunger of the liquid delivery device as the sensor carriage moves between the first position and the second position.

Particular embodiments described herein include a cover device. The cover device may include a body and a sensor. The body may be configured to at least partially receive the liquid delivery device. The sensor may be configured to output a sensor signal indicative of a radial position of the liquid delivery device relative to the body.

Particular embodiments described herein include a cover device. The cap device may comprise means for at least partially receiving the liquid delivery device, and means for detecting a radial position of the liquid delivery device.

The devices, systems, and techniques described herein can provide one or more of the following advantages. First, some embodiments described herein include a cover device that may facilitate placement of a liquid delivery device in a position relative to the cover device, thereby facilitating accurate, reliable, and repeatable measurements associated with the liquid delivery device. For example, the cap device includes one or more sensors that detect the axial and/or radial position of the liquid delivery device relative to the cap device and determine whether the liquid delivery device is in a predetermined axial and/or radial alignment relative to the cap device to facilitate accurate, reliable, and repeatable monitoring and determination of a status associated with the liquid delivery device, such as a volume of liquid within the reservoir, dose information (e.g., a volume of a previously delivered dose and an amount of drug remaining in the liquid delivery device), and/or other information related to the liquid delivery device and its operation.

Second, some embodiments described herein include a cap device that can assist a user in properly positioning the cap device on the liquid delivery device. For example, the cap device may generate feedback to a user to facilitate axial and/or radial alignment of the liquid delivery device relative to the cap device. Such feedback may include outputting information indicative of a current position of the liquid delivery system, and/or outputting information indicative of one or more actions required to arrange the liquid delivery system in a predetermined alignment with the cap device (e.g., relative rotation of the cap device and the liquid delivery device). Feedback may be provided in different forms, such as audible feedback, tactile feedback, or other visual or physical feedback. In various exemplary embodiments, the cover device may generate an output based on one or more sensor signals. Alternatively or additionally, the output may include user-perceivable snap-ins, mechanical interactions, etc., indicating proper axial alignment, radial alignment, etc.

Third, some embodiments described herein include a cap device that can perform one or more tasks based on radial alignment of the liquid delivery device relative to the cap device. For example, the cap device may detect a plunger position or other condition of the liquid delivery device based at least in part on information related to a radial position of the liquid delivery device. After the fluid delivery device is in a predetermined radial alignment, the plunger position or other condition of the fluid delivery device may be detected. Alternatively or additionally, information about the radial alignment of the liquid delivery device may be used to determine the status of the liquid delivery device.

Fourth, some embodiments described herein may facilitate dose detection at different times than dose delivery. For example, the cap device may be configured to detect a plunger position or other state of the liquid delivery device at a time when the liquid delivery device is in proper radial alignment with respect to the cap device, which may occur over a period of time after a priming dose and/or a preliminary capping of the liquid delivery device. In other words, the detection may occur independently of the time of dosing.

Fifth, some embodiments described herein can track changes in the state of the liquid delivery device over time and update dose information related to doses delivered at previous times as appropriate. For example, the cap device may be operable to measure/calculate a dose of liquid from the liquid delivery device (e.g., whether or not the liquid delivery device is in a particular predetermined alignment with the cap device, such as when the liquid delivery device is only axially inserted into the cap device and not rotated to a predetermined radial position relative to the cap device). The cap device is operable to identify when the liquid delivery device is moved into a predetermined alignment with the cap device and is further operable to measure/calculate a dose of liquid delivered from the liquid delivery device at a previous time. Such features may help track and output accurate information associated with the liquid delivery device over a period of time.

Sixth, some embodiments described herein include a sensor carriage that carries a sensor assembly (and/or the sensor assembly may be moved with limited or no manual user operation) that can facilitate consistent travel speeds and/or accelerations, thereby facilitating consistent and predictable sensor signals. User impact on sensor carriage dynamics may be reduced and manufacturing design tolerances that may lead to gaps or other unintended movement of the sensor carriage during sensor carriage operation may be reduced.

Seventh, some embodiments described herein may facilitate accurate and repeatable measurements related to liquid delivery devices by using a combination of sensor types. In some embodiments, the cover device includes one or more optical sensors and a position sensor, such as a linear potentiometer, optical encoder, rotary encoder, magneto potentiometer, membrane potentiometer, load cell, or the like. The combination of such sensor types facilitates accurate assessment of the relative positions of various features of the liquid delivery device and/or changes in the positions of various features during subsequent scans of the liquid delivery device.

Eighth, the cover device may facilitate efficient and cost-effective manufacturing and assembly processes by including relatively few sensors. In some embodiments, the cap device includes one or two liquid delivery device sensors (e.g., plunger sensors), such as one or two optical sensors, and a position sensor, such as a linear potentiometer, optical encoder, rotary encoder, magnetic potentiometer, membrane potentiometer, or the like. Thus, such configurations include relatively few sensors and reduce the number of assembly and/or calibration steps that might otherwise be applicable when multiple sensors are incorporated into a cover device.

Ninth, various embodiments described herein may include a cap device that is compatible with various liquid delivery device types. For example, the cover device may facilitate accurate and repeatable measurements, even when used with different liquid delivery device types, which may have different shapes, sizes, and features that interact differently with the sensors and other features of the cover device. The one or more optical sensors of the sensor carriage may be oriented to obtain a predetermined line of sight that may facilitate reliable plunger detection for a variety of different liquid delivery device types. For example, the optical sensors may be arranged such that at least one optical sensor is positioned to detect the plunger, even if the other optical sensor is blocked by a feature of the liquid delivery device in certain situations.

Tenth, some cap devices described herein improve the user experience of the liquid delivery system by automating some of the operations related to dose measurement and management. For example, the cap device may deliver an output informing the user of the previously delivered liquid dose, the duration since the previous dose, the number of doses remaining, the volume of liquid remaining, the expected remaining useful life of the liquid delivery device.

Eleventh, in some alternative embodiments, the cap devices described herein may improve the user experience of the liquid delivery system by facilitating semi-automated or automated operations. For example, little or no manual manipulation may be required in addition to engaging the cap device with the liquid delivery device. In some alternative embodiments including a movable sensor carriage, the sensor carriage may be placed in the first position by engaging the cover device to the liquid delivery device, and the sensor carriage may be automatically released such that the sensor carriage may be moved from the first position to the second position while operating to scan the liquid delivery device.

Twelfth, some embodiments described herein facilitate a durable cap device that may be operated for extended periods of time and/or may be used with many liquid delivery devices. For example, a single cap device may be reused with many disposable liquid delivery devices. The sensors of the cover device, such as one or more alignment sensors, one or more plunger sensors, and position sensors, such as one or more optical sensors, load sensors, linear potentiometers, optical encoders, rotary encoders, magneto-potentiometer, membrane potentiometer, etc., may be configured to have a consistent and/or predictable output over the operational life of the cover device.

Thirteenth, some embodiments described herein provide controlled sensor movement that can provide reliable and repeatable detection. For example, the motorized drive system may drive the sensor carriage substantially independently of manual input or movement. In some embodiments, the motorized drive system may drive the sensor carriage at different speeds, multiple directions, etc. to improve detection. Alternatively or additionally, after engagement between the cap device and the liquid delivery device, movement of the sensor carriage may be delayed for a predetermined period of time to facilitate measurement with little or no movement or external force to the system.

The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.

Brief description of the drawings

Fig. 1 is an exploded perspective view of an exemplary liquid delivery system.

FIG. 2A is a partial cross-sectional perspective view of the liquid delivery system with the sensor carriage in a first position.

FIG. 2B is a partial cross-sectional perspective view of the liquid delivery system with the sensor carriage in an intermediate position.

FIG. 2C is a partial cross-sectional perspective view of the liquid delivery system with the sensor carriage in a second position.

Fig. 3 is a partial cross-sectional perspective view of the liquid delivery system with the liquid delivery device disengaged from the cap device.

FIG. 4 is a flow chart of an exemplary method of detecting alignment and status of a liquid delivery device.

FIG. 5 is a flow chart of an exemplary method of detecting engagement and/or alignment of a liquid delivery device with respect to a cap device.

Fig. 6A schematically illustrates an exemplary position of the liquid delivery device relative to the cover device, and an exemplary display interface of the cover device.

Fig. 6B schematically illustrates another exemplary position of the liquid delivery device relative to the cover device, and another exemplary display interface of the cover device.

FIG. 7 is a partial cross-sectional perspective view of the cap device and the liquid delivery device showing predetermined features of the liquid delivery device detected by the sensor of the cap device when the liquid delivery device is engaged with the cap device in a predetermined alignment position.

FIG. 8 is a cross-sectional perspective view of a cap device and a liquid delivery device illustrating an exemplary feedback structure for generating mechanical feedback indicative of radial alignment of the liquid delivery device relative to the cap device.

Fig. 9 is a flow chart of an exemplary method for displaying information on a cover device.

Detailed Description

Referring to fig. 1 and 2A-C, an exemplary liquid delivery system 10 is shown that may be used to store and deliver liquid and output dosage information to a user. The liquid delivery system 10 includes a cap device 100 and a liquid delivery device 200. The cover device 100 may be positioned over at least a portion of the liquid delivery device 200 for storing the liquid delivery device 200 between uses. In an exemplary embodiment, the cap device 100 includes one or more sensors configured to detect the position of the liquid delivery device 200 and/or the status of the liquid delivery device 200 (e.g., the position of its plunger). The cover device 100 may also include one or more output devices, such as a display, a communication system, etc., configured to output information related to the location of the liquid delivery device 200 and/or the status of the liquid delivery device 200.

The liquid delivery device 200 may be configured to deliver a measured dose of liquid to a subject for treating a medical condition. For example, the fluid delivery device 200 may be a pen-type injector that is used to deliver a fluid (e.g., insulin) to manage diabetes. In the exemplary embodiment, liquid delivery device 200 includes a reservoir 201, a delivery end 202, a plunger 205, and a dial 206. The reservoir 201 contains a liquid that can be injected at the delivery end 202. Delivery end 202 provides a portion on which cap device 100 may be placed to store liquid delivery device 200 between uses. The delivery end 202 of the liquid delivery device 200 includes a septum 203 and an injection needle 204. The plunger 205 is operable to deliver a dose of liquid through the delivery end 202 with the reservoir 201. For example, a desired dose may be measured by operating dial 206 (e.g., by manually rotating dial 206) and delivered by advancing plunger 205. The plunger 205 is advanced via a rod (not shown) pushing a measured dose of liquid from the reservoir 201 through the delivery end 202 into the subject. In the exemplary embodiment, plunger 205 is advanced a particular distance such that a corresponding volume of liquid is dispensed from liquid delivery device 200.

The cover device 100 may include a body 110, one or more sensors 120, an interface assembly 130, a sensor bracket 140, a sleeve 150, and a motorized drive system 160.

The body 110 is configured to house various components of the cover device. The body 110 defines a cavity 111, the cavity 111 being configured to receive at least a portion of the liquid delivery device 200, such as at least a portion of the delivery end 202 and/or the reservoir 201. The cap device 100 may be positioned over the delivery end 202 and may hold the liquid delivery device 200 (e.g., between periods of use). The cap device 100 may protect the delivery end 202 from damage or contamination from the external environment and include an injection needle 204. The liquid delivery device 200 may be removed from the cavity 111 of the cap device 100 before each use and subsequently engaged with the cap device 100 after a dose has been delivered. Thus, the cap device 100 can be removed from the liquid delivery device 200 and replaced onto the liquid delivery device 200 multiple times. After the contents of a particular liquid delivery device 200 are discharged, the liquid delivery device 200 may be discarded and the cap device 100 may be used with a new liquid delivery device. In some exemplary embodiments, the liquid delivery device 200 may be discarded when the available contents of the liquid delivery device 200 are discharged, and the cap device 100 may be reused with multiple liquid delivery devices 200. In other exemplary embodiments, the cap device 100 may be associated with a particular liquid delivery device 200, and the cap device 100 and liquid delivery device 200 may be discarded as the contents of the reservoir 201 are discharged. In other exemplary embodiments, the cap device 100 may be associated with a particular liquid delivery device 200 and may refill the liquid delivery device 200 when the contents of the reservoir 201 are discharged or the reservoir 201 is replaced.

In various exemplary embodiments, the body 110 is a molded body, such as molded plastic. The body 110 may include a plurality of body portions, such as a body portion 110a and a cover portion 110b, assembled to form the body 110. In other exemplary embodiments, the body 110 may be made as a single piece defining the cavity 111.

One or more of the sensors 120 in the cover device 100 are configured to detect the position of the liquid delivery device 200 within the cover device 100. In an exemplary embodiment, the cap device 100 includes one or more sensors that output sensor signals that can be evaluated to detect the axial and/or radial position of the liquid delivery device 200 relative to the cap device 100. For example, the sensor may be used to determine that the liquid delivery device 200 is engaged at a predetermined axial and/or radial position relative to the cap device 100, thereby allowing for accurate measurement of the state of the liquid delivery device 200.

In addition, one or more of the sensors 120 may also detect the status of the liquid delivery device 200. In an exemplary embodiment, the cap device 100 includes one or more sensors 120 that output sensor signals that can be evaluated to detect the plunger 205, the position of the plunger 205, a change in position of the plunger 205 between successive engagements with the cap device 100 (e.g., a change in position after a dose is delivered), and/or other states of the liquid delivery device 200. The position of the plunger 205 and/or the change in position of the plunger 205 may be used to monitor the volume of the dose delivered by the liquid delivery device 200, the total volume of liquid remaining in the reservoir 201, the number of doses remaining in the reservoir 201, the duration of time remaining before the reservoir 201 is emptied, and/or other information related to the liquid delivery device 200.

In some embodiments, at least one of the sensors for detecting the status of the liquid delivery device 200 may be configured to further detect the position of the liquid delivery device 200. In other embodiments, the sensor for detecting the state of the liquid delivery device 200 may be different from the sensor for detecting the position of the liquid delivery device 200. For example, the sensor 120 may include a plurality of sensors, such as a first sensor 142 and a second sensor 143. In some embodiments, the first sensor 142 is used to detect a position (e.g., a radial position) of the liquid delivery device 200, and the second sensor 143 is used to detect a state of the liquid delivery device 200. In some embodiments, the first sensor 142 is used to detect a position (e.g., a radial position) of the liquid delivery device 200, and the first sensor 142 and/or the second sensor 143 may be used to detect a state of the liquid delivery device 200. For example, either the first sensor 142 or the second sensor 143 may be used to detect the status of the liquid delivery device 200, depending on which sensor is positioned along a predetermined line of sight based on the radial position of the liquid delivery device 200. Alternatively or additionally, both the first sensor 142 and the second sensor 143 may be used together to mutually verify and facilitate reliable determination of the status of the liquid delivery device 200. In some embodiments, the status of the liquid delivery device 200 may be detected only when the liquid delivery device 200 is detected to be disposed in a predetermined position (e.g., axially and/or radially aligned). For example, the state of the liquid transporting apparatus 200 is not detected using the sensor until it is detected that the liquid transporting apparatus 200 is disposed at a predetermined position. In other embodiments, the status of the liquid delivery device 200 may be detected before the liquid delivery device 200 is disposed in a predetermined position (e.g., axially and/or radially aligned) or whether or not the liquid delivery device is disposed in a predetermined position.

The sensor that detects the axial position (e.g., axial alignment) may be a sensor that detects engagement with the snap-in feature, or a sensor type that detects whether the cap device is secured to the liquid delivery device. As described below, the cap device may include a mechanical feedback device (e.g., a spring-biased axial post 302 configured to provide a clicking or snap-in feel upon engagement) and a sensor (e.g., a mechanical switch or other type of sensor configured to detect when the spring-biased axial post is engaged by the liquid delivery device) coupled to the mechanical feedback device. Examples of sensors for axial position detection are further described in U.S. patent No. 8,743,662 and U.S. provisional application No. 62/667,085, the disclosures of which are incorporated herein in their entirety to the appropriate extent.

The sensor that detects the radial position (e.g., radial alignment) may be a sensor that detects engagement with a snap-in feature that allows the liquid delivery device to snap into the cap device at a predetermined radial position. As described below, the cap device may include a mechanical structure (e.g., radial retention structure 800 with detents (detents) 802) configured to radially secure the liquid delivery device and generate mechanical feedback (e.g., a clicking or clicking feel upon engagement). Further, the cover device may include a sensor, such as a mechanical switch or other type of sensor, configured to detect when the mechanical structure is properly engaged by the liquid delivery device.

The sensor detecting the axial position and/or the radial position may be of various types, such as an optical sensor, a mechanical switch or other suitable type determining such a position of the liquid delivery device relative to the cover device.

In various exemplary embodiments, the first sensor 142 and the second sensor 143 are the same type of sensor. In some exemplary embodiments, the first sensor 142 differs from the second sensor 143 in one or more characteristics. For example, the first sensor 142 may have a different sensor resolution or accuracy than the second sensor 142. For example, the first sensor 142 for detecting the position of the liquid delivery device 200 may have a lower sensor resolution or accuracy than the second sensor 143 for detecting the state of the liquid delivery device 200. For example, lower resolution or accuracy may help reduce the overall cost of the cover device 100 and/or increase calibration efficiency. In some embodiments, either the first sensor 142 or the second sensor 143 (or both) may be used to detect the position and status of the liquid delivery device 200.

At least one of the sensors 120 may be supported by a sensor bracket 140 movably arranged in the cover device 100. For example, when the position sensor 145 is fixedly arranged within the cover device 100, the first sensor 142 and the second sensor 143 are carried by and movable with the sensor carriage 140. The position sensor 145 may be configured to detect an axial position or distance of the sensor carrier 140 relative to the cover device 100.

The sensors 120, such as the first sensor 142 and the second sensor 143, are configured to output sensor signals indicative of characteristics of the liquid delivery device 200. The output signal from the sensor may vary depending on the physical characteristics of the liquid delivery device 200 encountered by the sensor, and thus the output signal may be different at different axial and/or radial positions relative to the liquid delivery device 200. For example, as the liquid delivery device 200 rotates relative to the cap device 100 (e.g., as the user positions the cap device 100 on the liquid delivery device 200), a change in the output signal of the sensor (e.g., sensor 142) may be evaluated to determine one or more predetermined features of the liquid delivery device 200 (e.g., a distal edge or chamfer of the reservoir window) that may indicate that the liquid delivery device 200 is in a predetermined position (e.g., a predetermined radial alignment). Further, as sensor carriage 140 moves relative to liquid delivery device 200, changes in the output signals of sensors (e.g., sensor 142 and/or sensor 143) may be evaluated to determine a leading edge of a leading end of reservoir 201 (e.g., at delivery end 202), a leading end of plunger 205, a trailing end of plunger 205, and/or other properties of liquid delivery device 200. The detected change in position between a series of doses, e.g., a change in position of the plunger 205 before a dose has been delivered and after a dose has been delivered, may be used to evaluate the volume of dose delivered by the liquid delivery device 200, the total volume of liquid remaining in the reservoir 201, the number of doses remaining in the reservoir 201, the duration of time remaining before the reservoir 201 is emptied, the time of previous doses (e.g., the time of replacement of the cap device 100 onto the liquid delivery device 200), the time elapsed since the last dose (e.g., the time elapsed since replacement of the cap device 100 onto the liquid delivery device 200), and/or other information related to the liquid delivery device 200. Alternatively or additionally, the relative position of one or more of these detected features, or the distance between one or more of these detected features, may be used to evaluate dose information related to the liquid delivery device 200.

In the exemplary embodiment, sensor 142 includes a transmitter 142a and a receiver 142b, such as a light transmitter 142a and a light receiver 142b. The light emitter 142a emits radiation that can be detected by the light receiver 142b, and in some embodiments the light emitter 142a can include an LED or a laser diode. The sensor 142 may output a sensor signal related to an amount of radiation received by the light receiver 142b (e.g., an amount of radiation received from the light emitter 142 a). Thus, the sensor signal may depend on the characteristics of the liquid delivery device 200 present in the path 142C (e.g., fig. 2A-2C) between the optical transmitter 142A and the optical receiver 142b. Thus, for example, the amount of radiation received by the light receiver may be relatively low when there are different structures, plungers, or other solid structures in the path 142c, and relatively high when only the transparent wall of the reservoir and its liquid contents are present in the path 142 c.

The emitter 142a and the receiver 142b may be arranged in alignment with each other such that the optical path 142c between the emitter 142a and the receiver 142b extends perpendicular (e.g., substantially perpendicular, within 10 ° of a precisely perpendicular direction) to the central longitudinal axis a of the cavity 111. In some embodiments, the emitter 142a is configured to generate a narrow beam of light with limited spread outside the optical path 142c, such as by the emitter 142a emitting a narrow beam of light and/or by a collimating structure configured to focus the output of the emitter 142a along the path 142 c. In various exemplary embodiments, the radiation emitted by emitter 142a may be in the visible wavelength and/or the invisible wavelength range.

In some exemplary embodiments, the sensor 142 may be a reflective sensor that detects reflected light. The reflective sensor 142 may detect a color transition indicative of the plunger 205, e.g., a transition from a relatively higher transparency and/or light color of the liquid and/or reservoir 201 to a relatively lower transparency and/or dark color (e.g., red, orange, black, etc.) of the plunger 205.

In an exemplary embodiment, the configuration of sensor 143 is similar to sensor 142, including a transmitter 143a and a receiver 143b defining a path 143 c.

Still referring to fig. 1, the interface component 130 of the cover device 100 includes various components that can calculate, display, store, and/or communicate sensor signals output by the sensors 120. In an exemplary embodiment, interface assembly 130 includes a display 121, a user input device 122, a communication interface 123, a memory 124, a processor 125, a speaker 126, and a vibrator 128. One or more components may be in electrical communication with one or more other components via the circuit board 127. The processor 125 may be configured with logic that controls the operation of one or more components and processes sensor signals received from the sensors 120 of the cover device 100. At least one of the interface component and other components may be housed in the housing 110.

In some embodiments, the display 121 provides visual output to a user related to the position of the liquid delivery device 200 relative to the cap device 100 and/or the status of the liquid delivery device 200 and/or the status of the cap device 100. For example, the display 121 may be an LED or LCD display. In some embodiments, the display 121 may provide a visual indication related to the axial and/or radial position of the liquid delivery device 200 relative to the cap device 100. Further, the display 121 may provide visual indications relating to the volume of the dose delivered by the liquid delivery device 200, the total volume of liquid remaining in the reservoir 201, the number of doses remaining in the reservoir 201, the duration of time remaining before the reservoir 201 is emptied, the time of the previous dose (e.g., the time of replacement of the cap device 100 onto the liquid delivery device 200), the time elapsed since the last dose (e.g., the time elapsed since replacement of the cap device 100 onto the liquid delivery device 200), and/or other information relating to the liquid delivery device 200.

Alternatively or additionally, the cap device 100 may comprise an audio and/or vibration alert related to the position of the liquid delivery device 200 relative to the cap device 100 and/or the status of the cap device 100 and/or the liquid delivery device 200. The processor 125 may control the audio output of the speaker 126 to output an audible alert, or the vibrator 128 to output a vibratory alert, which may be considered an indication of the axial and/or radial position of the liquid delivery device 200 relative to the cap device 100. Further, such audible or vibratory alarms may be used to provide an indication of the volume of the dose delivered by the liquid delivery device 200, the total volume of liquid remaining in the reservoir 201, the number of doses remaining in the reservoir 201, the duration of time remaining before the reservoir 201 is emptied, the time of previous doses (e.g., the time of replacement of the cap device 100 onto the liquid delivery device 200), the time elapsed since the last dose (e.g., the time elapsed since replacement of the cap device 100 onto the liquid delivery device 200), and/or other information related to the liquid delivery device 200. Alternatively or additionally, vibrator 128 may impart vibration to liquid delivery device 200. Vibrator 128 may be activated to promote mixing of the contents of liquid delivery device 200 and/or to reduce formation or accumulation of sediment (e.g., on the front surface of the plunger and/or the surface of reservoir 201).

The user input device 122 is configured to facilitate user interaction with the cover device 100. In an exemplary embodiment, the user input 122 includes one or more buttons, switches, or other control interfaces operable to control the cover device 100. For example, the user input device 122 may be operated by a user to activate the cover device 100 and/or select information to be displayed by the display 121. As described herein, in some embodiments, the cap device 100 may be automatically activated by engagement with the liquid delivery device 102. Alternatively or additionally, the user input device 122 may be operable to reset the settings of the cap device 100 and/or the memory 124, for example, when the cap device 100 is engaged with a new liquid delivery device 200. In some exemplary embodiments, the cover device 100 does not include the user input device 122. The cover device 100, which does not include a user input device, may facilitate perception of the fully automatic cover device 100 and/or improve user operability.

The cap device 100 may communicate with one or more other components of the liquid delivery system to deliver and/or receive information related to the position of the liquid delivery device 200 relative to the cap device 100 and/or the status of the cap device 100 and/or the liquid delivery device 200. For example, the communication device 123 of the cover device 100 is configured to communicate with one or more components remote from the cover device 100. The communication device 123 may include a wireless communication printed circuit component configured for wireless communication via, for example, short wavelength UHF radio frequency, RF communication, WI-FI, bluetooth, ZIGBEE, or the like. Alternatively or additionally, the communication device 123 may include an electrical port for wired communication with another electronic device. In various exemplary embodiments, the communication device 123 is configured for two-way communication, such as with a mobile device having software configured to transmit and receive communications with the cover device 100. Alternatively, the cover device 100 may be configured for unidirectional communication, such as uploading information only to the mobile device, or receiving information only from the mobile device.

The communication device 123 may be configured to communicate with an electronic device configured with diabetes management software. For example, the communication device 123 may transmit information related to the liquid delivery device 200, which may be further processed by the electronic device. In this manner, the cap device 100 may facilitate review of information collected by its sensors by a remote user or healthcare provider, provide alerts associated with the liquid delivery system 200 via electronic means (e.g., associated with a planned time of injection, an almost empty liquid delivery device, etc.), and/or facilitate additional processing and analysis of information collected by the cap device 100.

The cover device 100 may include a power source 170. In an exemplary embodiment, the power source 170 includes one or more batteries, such as alkaline batteries, nickel cadmium batteries, lithium ion batteries, and the like. In some embodiments, the power source 170 is associated with an axial position device 300 configured to be activated when engaged with a portion of the axial insertion of the liquid delivery device 200 into the cap device 100. When activated, the axial position device 300 is operable to switch the cover device 100 between an inactive or low power state and an active or operational state in which the sensor of the cover device 100 is in an active state. In other embodiments, the power source 170 may be associated with a micro-switch configured to switch the cover device between an inactive or low power state and an active or operational state. Alternatively or additionally, sensor signals from one or more sensors (e.g., one or more position sensors) of the cover device 100 may provide an alert to the processor 125 to switch the cover device to an active or operational state.

Still referring to fig. 1, the sensor bracket 140 of the cover device 100 is configured to carry one or more sensors 120 and is movably positioned within the cavity 111 of the body 110. In some embodiments, the sensor carriage 140 is configured to travel axially along at least a portion of the liquid delivery device 200 within the cavity 111. The cavity 111 may be sized to accommodate the size of the liquid delivery device 200 and the path of the sensor carriage 140.

The sensor bracket 140 facilitates detection of a characteristic, such as a position and/or status of the liquid delivery device 200, by carrying one or more sensors along the liquid delivery device 200 between a first position and a second position. In an exemplary embodiment, the sensor bracket 140 is movable relative to the cavity 111 between a first position and a second position when the liquid delivery device 200 is held in a fixed position relative to the cavity 111 (e.g., the sensor bracket 140 is movable when the liquid delivery device 200 is in fixed engagement with the cover device 100). Such exemplary movable positions of the sensor carriage 140 are shown and described in more detail with reference to fig. 2-4 below.

The sensor bracket 140 may include a plurality of sensors, such as a first optical sensor 142 and a second optical sensor 143. In some embodiments, one of the plurality of sensors (e.g., one of the first optical sensor 142 and the second optical sensor 143) may be used to detect a radial position of the liquid delivery device relative to the cap device. For example, as described above, the first sensor 142 is configured to detect a radial position of the liquid delivery device, and the second sensor 143 is configured to detect a state of the liquid delivery device (e.g., plunger position).

The first optical sensor 142 includes a first transmitter 142a and a first receiver 142b, and the second optical sensor 143 includes a second transmitter 143a and a second receiver 143b. The first emitter 142a may be aligned with the first receiver 142b and the second emitter 143a aligned with the second receiver 143b (e.g., such that the first receiver 142b receives radiation primarily or exclusively from the first emitter 142a and the second receiver 143b receives radiation primarily or exclusively from the second emitter 143 a). For example, the first emitter 142a and the second receiver 143b and the second emitter 143a and the first receiver 142b are misaligned and do not define an optical path perpendicular to the longitudinal axis of the cavity 111. Alternatively, the first transmitter 142a may be aligned with the second receiver 142b for sensing and/or the second transmitter 143a may be aligned with the first receiver 143b for sensing. In an exemplary embodiment, the first and second transmitters 142a and 143a and the first and second receivers 142b and 143b are spaced 90 ° apart from each other around the circumference of the sensor bracket 140. Accordingly, the first and second sensors 142 and 143 may define first and second paths 142c and 143c perpendicular to each other. In some embodiments, the first path 142c and/or the second path 143c do not intersect the central longitudinal axis of the cavity 111 or the central longitudinal axis of the liquid delivery device 200. The first path 142c and/or the second path 143c that do not intersect the central axis may facilitate detection of the rear surface 205b of the plunger 205 by avoiding rod blocking of the plunger. Although the first sensor 142 and the second sensor 143 are mainly described as optical sensors, one or both of them may be other types of sensors. For example, the first sensor 142 may be configured to detect a radial position of the liquid delivery device, and the first sensor 142 may be configured as a mechanical switch that may be used to determine whether the liquid delivery device is snapped into a predetermined radial position within the cap device.

In various exemplary embodiments, the relative radial position of the sensor 142 relative to the liquid delivery device 200 may determine whether there is an appropriate line of sight through the reservoir 201, thereby determining an accurate determination of the position of the plunger 205, which may be used to determine the amount of liquid remaining in the liquid delivery device. Some embodiments of the cap device are configured to be compatible with various types of liquid delivery devices, where each liquid delivery device has various features (e.g., frames, indicia, bumps, numbers, hash lines, and other barriers) at different locations. Depending on the radial position of the liquid delivery device relative to the cap device, the position of such features may block or distort light from the emitter 142a such that the forward and/or rearward edges of the plunger 205 are obscured or difficult to determine, thereby affecting the reliability of the determination of the amount of liquid remaining in the liquid delivery device 200 and/or the reliability of the determination of the dosage of liquid in the liquid delivery device 200. The radial alignment position may be determined such that such features of each liquid delivery device neither block the sensor from detecting the plunger nor distort the view of the plunger. The radially aligned position of the liquid delivery means relative to the cap means provides an optimal optical path across the reservoir along its entire length so that the plunger can be viewed and detected at any location along the length of the reservoir.

In some embodiments where there are multiple optical sensors 142, 143, each emitter 142a, 143a may emit a different wavelength, and the receivers 142b, 143b may likewise be wavelength specific, such as by including a bandpass filter. Alternatively or additionally, each sensor may transmit and detect radiation pulses at different time periods of the cycle (e.g., using time division multiplexing). In some embodiments, the sampling rate may be greater than 100Hz, greater than 1000Hz, or higher.

Alternatively or additionally, the sensor carrier 140 may further comprise a position sensor 145 as the sensors 142, 143, the position sensor 145 being configured to output a sensor signal indicative of the position or distance. In an exemplary embodiment, the cap device 100 includes a position sensor 145, the position sensor 145 outputting a sensor signal indicative of the position of the sensor carriage and/or the distance the sensor carriage travels between the first position and the second position (e.g., when the sensor carriage 140 moves along the liquid delivery device 200 or between subsequent dosing of the liquid delivery device 200). In an exemplary embodiment, the position sensor 145 comprises a linear potentiometer. The resistive element is positioned at least partially along the length of the cavity 111, such as at a sidewall of the body 110 or sleeve 150. The wiper blade may be located on the sensor carrier 140.

The position sensor 145 may output a sensor signal (e.g., a voltage) that varies depending on the position of the wiper along the resistive element (e.g., and the position of the sensor bracket 140 along the cavity 111). For example, a particular voltage may be associated with a particular location along the resistive element, and each time the wiper travels along the resistive element, the voltage may be consistent and repeatable. The sensor 145 may have a unique voltage output characteristic for each position of the blade and may be calibrated to achieve high accuracy and repeatable measurements.

Alternatively or additionally, as a linear potentiometer, the position sensor 145 may include one or more other sensor types that provide an indication of a position that may be related to the sensor signal output by the sensor 142 and/or the sensor 143. For example, the position sensor 1145 may include a linear encoder, a rotary encoder, a magneto-potentiometer, a membrane potentiometer, a load cell, and the like.

Still referring to fig. 1, the sleeve 150 of the cap device 100 is configured to be at least partially disposed within the cavity 111 of the body 110 and to receive at least a portion of the liquid delivery device 200. The sleeve 150 may include a main wall 152 and a front wall 154, the front wall 154 extending axially from the main wall 152 and configured to receive a delivery end 202 and/or an injection needle 204 of the liquid delivery device 200. The sleeve 150 at least partially encloses the needle 204 (e.g., proximate the front of the cap device 100) and the reservoir 201 between the needle 204 and the opening 114 of the body 110. The sensor bracket 140 may be movable between the sleeve 150 and the inner wall of the body 110, and during operation of the sensor bracket 140, the sleeve 150 may be located between the liquid delivery device 200 and the sensor bracket 140.

Alternatively or additionally, the sleeve 150 may include one or more retention features that engage the liquid delivery device 200 and limit axial and/or radial movement of the liquid delivery device 200 relative to the body 110 of the cap device 100. As described herein, embodiments of the retention feature may include the axial position device 300, a portion of the sleeve 150 (e.g., the flange wall 158 thereof), and the radial retention structure 800.

In some embodiments, the sleeve 150 includes a track 156, the track 156 configured to guide and/or limit movement of the sensor carriage 140. In an exemplary embodiment, the track 156 is configured as one or more rails that engage with complementary features (e.g., axial grooves) of the sensor carrier 140. In the illustrated embodiment, the track 156 includes two rails that extend axially along at least a portion of the length of the sleeve 150 and are oppositely disposed outside of the sleeve 150. The track 156 defines a path along which the sensor carriage 140 travels, such as in a longitudinal direction between a first position proximate the front wall 112 of the body 110 and a second position closer to the opening 114 of the body 110.

The motorized drive system 160 operates to drive the sensor bracket 140 along a longitudinal axis of the cover device 100, such as along a longitudinal axis extending centrally through the front wall 112 and the opening 114 of the body 110. For example, the electric drive system 160 includes a motor 161 and a lead screw 162 directly or indirectly connected to a drive shaft of the motor 161. The motor 161 may be mounted to a motor mounting block 172, the motor mounting block 172 being located in the cavity 111 proximate the front wall 112 of the body 110. Rotation of the lead screw 162 caused by operation of the motor 161 causes the sensor bracket 140 to move axially. Rotation of the motor 161 in a first direction causes the sensor bracket 140 to move toward the opening 114 of the cavity 111, and rotation of the motor 161 in a second, opposite direction causes the sensor bracket 140 to move toward the front wall 112 of the body 110. In an exemplary embodiment, the motorized drive system 160 may thus drive the sensor carriage 140 between any number of discrete points along the lead screw 162.

Although primarily depicted and described herein with respect to operating the cover device 100 using the electric drive system 160, it should be appreciated that the principles and configurations disclosed herein are equally applicable to other types of cover devices, such as non-electric cover devices.

Referring now to fig. 2A, 2B and 2C, the movable sensor carrier 140 is shown in a first position (fig. 2A), an intermediate position (fig. 2B) and a second position (fig. 2C). When the liquid delivery device 200 is at least partially received within the body 110, the sensor carriage 140 may be moved to any position from the first position to the second position, or vice versa. In some embodiments, the sensor bracket 140 is movable between a first position and a second position while the liquid delivery device 200 remains in a fixed position relative to the body 110 of the cap device 100. Movement of the sensor carriage 140 between the first and second positions facilitates detection of characteristics of the liquid delivery device 200 at a plurality of positions of the liquid delivery device 200. The sensors 142 and 143 may generate output signals continuously or at a relatively high frequency (e.g., between 0.1kHz and 100kHz, between 5kHz and 50kHz, or about 30 kHz) as the sensor carriage 140 moves between the first and second positions. In some embodiments, operation of the sensors 142 and 143 may be described as generating a scan of a portion of the liquid delivery device 200 as the sensor carriage 140 travels between the first and second positions, and output signals from the sensors 142 and 143 (e.g., alone or in combination with one or more sensors, such as the position sensor 145) may be evaluated to determine the position of the plunger 205 within the reservoir 201, a change in the position of the plunger 205 within the reservoir 201, and/or other conditions of the liquid delivery device 200.

Additionally or alternatively, the sensor bracket 140 may be movable to a predetermined position (i.e., a radial alignment detection position) at which the sensor 142 of the sensor bracket 140 is configured to detect the radial position of the liquid delivery device 200 engaged with the cap device 100. As described herein, when the sensor bracket 140 is disposed in a radial alignment detection position between the first and second positions, the sensor 142 of the sensor bracket 140 is operable to detect a predetermined feature of the liquid delivery device 200 (e.g., one of the opposing axial tips, edges, and/or other features of the window 220 formed in the reservoir 201) to determine that the liquid delivery device 200 is in a desired radial position (i.e., a radial alignment position) relative to the cap device 100.

In some embodiments, the radial alignment detection position of the sensor carrier 140 is disposed near the first position (fig. 2A). In other embodiments, the radial alignment detection position is the same as the first position. In yet other embodiments, the radial alignment detection position is disposed near or the same as the second position (fig. 2C). In yet other embodiments, the radial alignment detection position may be any position between the first position and the second position.

In different embodiments, the sensor bracket 140 may be configured to be initially disposed in different positions. In an exemplary embodiment, the sensor bracket 140 may be configured to be disposed in a first position as a default position and return to the first position after one or more operations of a different position. Alternatively or additionally, the sensor carrier 140 may be configured to be arranged in the radial alignment detection position as a default position and to return to the radial alignment detection position after one or more operations of the different positions. In some embodiments, the sensor bracket 140 may be configured to be disposed in the second position as a default position and return to the second position after one or more operations of the different positions. In yet other embodiments, other positions of the sensor bracket 140 may be used as default positions.

The sensor bracket 140 may return to its default position at any time, such as shortly after the liquid delivery device 200 is engaged with the cap device 100, after one or more predetermined processes (e.g., a scanning process in which the sensor bracket 140 moves between the first and second positions to detect the position of the plunger 205) are completed, and/or shortly after the liquid delivery device 200 is removed from the cap device 100.

In the first position shown in fig. 2A, the sensor bracket 140 is positioned proximate the front wall 112 of the body 110. In some embodiments, the sensor bracket 140 may be introduced into the first position by an operation of inserting the liquid delivery device 200 within the cavity 111. In other embodiments, the sensor bracket 140 may be arranged in the first position by default prior to inserting the liquid delivery device 200 into the cavity 111.

The sensor carriage 140 is movable from a first position toward a second position by an electric drive system 160. The sensor 142 of the sensor carriage 140 may output a sensor signal as the sensor carriage 140 travels along the liquid delivery device 200 between the first position and the second position. In the first position shown in fig. 2A, a field of view 142c (e.g., or optical path or line of sight) between the emitter 142A and the receiver 142b intersects the delivery end 202 of the liquid delivery device 200 or a portion of the liquid delivery device 200 near the delivery end 202. The sensor signal may be evaluated (e.g., by the processor 125) to detect the presence of the front end of the reservoir 201. In some embodiments, a particular amplitude of the sensor signal or an increase in the amplitude of the sensor signal may thus provide an indication of the front end of the reservoir 201.

Fig. 2B shows the sensor carriage 140 in an intermediate position between the first position and the second position. The field of view 142c between the emitter 142a and the receiver 142b passes through an intermediate location of the reservoir 201. The walls of reservoir 201 and the liquid within reservoir 201 may provide relatively low opacity for radiation transmission between emitter 142a and receiver 142b such that the sensor signal is relatively high in the intermediate position.

Fig. 2C shows the sensor carriage 140 in a second position in which the sensor carriage 140 is positioned proximate the opening 114 of the cavity 111. In the second position, the sensor carriage 140 has traveled beyond the front surface 205a of the plunger 205 such that the field of view 142c intersects the plunger 205. The presence of the front surface 205a may be detected by sensor signal changes at the location where the field of view 142c encounters the front surface 205 a. For example, since the plunger 205 is present in the path 142c, the amplitude of the radiation received by the receiver 142b may be reduced or decreased.

After traveling beyond the front surface 205a of the plunger 205, the sensor 142 may continue to detect characteristics of the liquid delivery device 200. For example, the rear surface 205b may be detected based on a change in sensor output at a location where the rear surface 205b intersects the path 142 c. For example, since there is no plunger 205 intersecting path 142c, the amplitude of the radiation received by receiver 142b may be increased or enhanced. The length of the plunger 205 between the front surface 205a and the rear surface 205b is fixed, and thus the front surface 205a or the rear surface 205b may be used to evaluate the position of the plunger 205. Detecting the front surface 205a and the rear surface 205b of the plunger 205 may improve the accuracy of evaluating the plunger 205. For example, the position of the plunger 205 may be accurately located even if another feature (e.g., a frame, a marker, etc.) of the liquid delivery device 200 blocks either the front surface 205a or the rear surface 205b.

The position of the plunger 205 or the change in position of the plunger 205 may be estimated in conjunction with the sensor signal output by the position sensor 145. In an exemplary embodiment, the sensor signal generated by the position sensor 145 changes in a predictable manner as the sensor carriage 140 moves between the first position and the second position. For example, the sensor signal for a location sensor 145 of a particular location may be associated with the sensor signal from a sensor 142 of the particular location. The change in position of the plunger 205 before the dose has been delivered and after the dose has been delivered may be detected, as well as the volume of the delivered dose calculated based on the change in position. Alternatively or additionally, the distance between locations associated with various output signals from the sensor 142, such as the distance between the front end of the reservoir 201 and the front surface 205a of the plunger 205, and the remaining volume of the reservoir 201 calculated based on the distance, may be evaluated.

Referring to fig. 3, an exemplary axial position device 300 is shown when the liquid delivery device 200 is not located within the body 110 of the cap device 100. The axial position device 300 is configured to engage a portion of the liquid delivery device 200 when the liquid delivery device 200 is axially inserted into the cap device 100. The axial position device 300 is configured to provide mechanical feedback when the liquid delivery device 200 is inserted into a predetermined axial position within the cavity 111 of the body 110. For example, the sleeve 150 includes a flange wall 158, the flange wall 158 being formed between the main wall 152 and the front wall 154 and configured to engage a front end 208 (e.g., delivery end 202) of the liquid delivery device 200 to limit axial movement of the liquid delivery device 200 within the cavity 111 of the body 110. The axial position device 300 is configured to provide mechanical feedback to a user grasping the liquid delivery device 200 and/or the cap device 100 when the front end of the liquid delivery device 200 is about to engage the flange wall 158 of the sleeve 150.

In some embodiments, the axial position device 300 may include a longitudinal post 302 movably mounted to the motor mounting block 172. A spring 304 may be engaged between a rear portion of post 302 and a portion of motor mounting block 172 to bias post 302 toward motor mounting block 172 (i.e., toward cavity 111 or sleeve 150 in a direction opposite to the direction of insertion of liquid delivery device 200). The distal end 306 of the post 302 extends through the flange wall 158 of the sleeve 150 and into the space surrounded by the main wall 152 of the sleeve 150. Thus, front end 208 of fluid delivery device 200 contacts distal end 306 of post 302 and pushes post 302 against the biasing force of spring 304. In some embodiments, post 302 may be pushed back against spring 304 until front end 208 of liquid delivery device 200 abuts flange wall 158 of sleeve 150.

Additionally or alternatively, the axial position device 300 is configured to detect axial engagement of the liquid delivery device 200 with the cap device 100. For example, the axial position device 300 includes one or more switches or sensors configured to detect the post 302 being pushed by the liquid delivery device 200 and to generate a sensor signal indicative of the axial engagement of the liquid delivery device 200 relative to the cap device 100 (e.g., sleeve 150). In response, the cap device 100 may be activated/energized and/or initiate one or more operations, such as detecting a radial position of the liquid delivery device 200.

Various exemplary cap devices described herein can facilitate efficient and repeatable techniques for assessing the position (e.g., alignment) and/or status of a liquid delivery device. Referring to fig. 4, a flow chart of an exemplary method 400 of detecting alignment and status of a liquid delivery device is shown. The method 400 includes an operation 402 of receiving at least a portion of a liquid delivery device within a cavity of a cap device. In various exemplary embodiments, the liquid delivery device may have similar features and characteristics as the liquid delivery device 200 described herein, and may be a pen injector device for administering a dose of insulin. The cover device may have similar features and characteristics as the cover device 100 described herein.

Operation 402 may include axially inserting into the cavity of the cap device and/or radially rotating the liquid delivery device relative to the cap device until the liquid delivery device is axially engaged/aligned and/or radially aligned (e.g., aligning a central longitudinal axis of the liquid delivery device with a central longitudinal axis of the cap device cavity), and/or aligning a radial position of the liquid delivery device relative to the cap device cavity. Alternatively or additionally, the liquid delivery device may be aligned with the cap device into one or more discrete axial and/or radial alignment positions. For example, the liquid delivery device and/or the cap device may have asymmetric features, non-circular shapes, and/or other mechanical/geometric features that facilitate receiving the liquid delivery device at one or more discrete locations (e.g., selected based on a predetermined location of one or more sensors within the cap device). Alignment of the liquid delivery device with the cap device in a particular orientation may facilitate desired interaction between one or more sensors of the cap device and the liquid delivery device by reducing interference or blocking of frames, indicia, opaque regions, and/or other features.

In an exemplary embodiment, operation 402 of receiving the liquid delivery device using the cavity of the cap device may include fixedly engaging the cap device with the liquid delivery device. For example, after operation 402, relative movement between the liquid delivery device and the cap device may be limited such that the liquid delivery device is non-rotatable within the cavity and/or the liquid delivery device is non-longitudinally movable within the cavity.

The method 400 includes an operation 404 of detecting alignment of the liquid delivery device. Operation 404 may include detecting rotation of the liquid delivery device relative to the cap device to a predetermined radial position (e.g., a radial alignment position). The predetermined radial position may be one or more positions that facilitate accurate detection of the position and movement of the plunger in the liquid delivery device by a sensor of a sensor bracket in the cap device. Alternatively or additionally, in some embodiments, operation 404 may include determining that the liquid delivery device is inserted into the cap device and placed in a predetermined axial position (i.e., an axially aligned position). For example, the cap device comprises one or more sensors that generate sensor signals when the liquid delivery device is engaged with the cap device at such predetermined axial positions. The predetermined axial position may be a position allowing the liquid delivery device to enter a predetermined radial position when the predetermined axial position is rotated. In other embodiments, operation 404 does not include detecting the liquid delivery device entering the predetermined axial position. The cap device may be configured to provide mechanical feedback (e.g., axial resistance) when the liquid delivery device approaches the predetermined axial position, and/or to provide an axial structure that prevents axial movement of the liquid delivery device at the predetermined axial position when the liquid delivery device is axially inserted into the cap device.

The liquid delivery device remains in fixed engagement with the cap device when the liquid delivery device is in the predetermined alignment position. The relative movement between the liquid delivery device and the cap device may be limited such that the liquid delivery device is non-rotatable within the cavity and/or the liquid delivery device is non-longitudinally movable within the cavity. Exemplary operations 404 are further described herein, such as with reference to fig. 5.

In some embodiments, the radial alignment position may include a plurality of radial alignment positions, each radial alignment position providing a predetermined line of sight for accurate plunger detection. In other embodiments, the radial alignment position may be a single radial alignment position that provides such a predetermined line of sight for accurate plunger detection. Where multiple sensors are used, such multiple sensors (e.g., first sensor 142 and second sensor 143) are used to detect one or more of a plurality of radially aligned positions.

The method 400 includes an operation 406 of providing a user guide to assist a user in engaging the liquid delivery device with the cap device in a predetermined alignment position (e.g., an axial and/or radial alignment position). In some embodiments, the cover device includes an output device, such as a display screen, that presents one or more symbols (e.g., symbols, text, letters, numbers, etc.) that indicate the status of the position of the liquid delivery device relative to the body. For example, the cover device may display symbols representing steps of engaging the liquid delivery device with the cover device into a predetermined alignment position. In some embodiments, the cover device displays such symbols until the liquid delivery device is detected at such predetermined alignment positions. The steps may include first inserting the liquid delivery device at least partially axially into the cap device until the liquid delivery device is disposed in a predetermined axial position (e.g., placing the cap device 100 over the liquid delivery device 200 such that they snap together), and then rotating the liquid delivery device relative to the cap device until the liquid delivery device is detected at the predetermined radial position. For example, there may be corresponding snap-in features in the cap device 100 and the liquid delivery device 200 such that when a user rotates the cap device 200 relative to the liquid delivery device 200 toward a predetermined radial alignment, the cap device 100 and the liquid delivery device 200 snap into the predetermined radial alignment. Exemplary operation 406 is further described herein, for example, with reference to fig. 9.

In some embodiments, operation 406 may include determining that the liquid delivery device is disposed at a predetermined position relative to the cap device (e.g., a position that enables accurate monitoring of the plunger position, thereby allowing accurate determination of the amount of content remaining in the liquid delivery device), and providing guidance based on such determination. For example, operation 406 may include actively monitoring the position of the liquid delivery device relative to the cap device over time or at regular intervals, and determining whether the liquid delivery device is in axial and/or radial alignment relative to the cap device.

The method 400 may include an operation 408 of driving a sensor carriage including one or more sensors (e.g., the sensor 142). Operation 404 may include driving the sensor carriage by an electric drive system including an electric motor. For example, an electric drive system may drive the sensor carriage from a first position to a second position, or vice versa. One or more sensor signals located on the sensor carriage operate to output sensor signals indicative of one or more characteristics of the liquid delivery device as the sensor carriage moves between the first and second positions.

In some exemplary embodiments, operation 408 is performed in a state in which the liquid delivery device is in a predetermined alignment position relative to the cap device as determined in operation 404. Alternatively or additionally, even if the liquid delivery device is not determined to be in a predetermined radial alignment position relative to the cap device, but rather in a predetermined axial position, operation 408 may be performed to determine if the plunger position can be detected, even if the determination is less accurate than if the liquid delivery device were in the predetermined radial alignment. In some embodiments, operation 408 may be performed before determining that the liquid delivery device is in the predetermined radial alignment position relative to the cap device and after again determining that the liquid delivery device is in the predetermined radial alignment position. In some cases, operation 408 may be delayed in time after the liquid delivery device is placed in the predetermined axial position, providing the user with enough time to rotate the liquid delivery device 200 relative to the cap device 100 to achieve the predetermined radial alignment, but even if the cap device 100 is not in the predetermined radial alignment, operation 408 may be performed after a predetermined amount of time after the liquid delivery device is placed in the predetermined axial position. If the user then rotates the cap device 100 relative to the liquid delivery device 200 to achieve the predetermined radial alignment, the cap device 100 may again perform operation 408 to determine the position of the plunger and the amount of liquid remaining in the liquid delivery device 200. The subsequent results from operation 408 after the predetermined radial alignment is achieved may be compared to earlier results outside of the predetermined radial alignment and/or used to correct, verify, update, replace, etc. the earlier results.

In some exemplary embodiments, operation 408 of driving the sensor carriage may be initiated without additional manual operations. For example, the cap device may detect engagement with the liquid delivery device (e.g., by a sensor) and initiate operation of the electric drive system upon detection of the liquid delivery device.

Operation 408 may optionally include driving the sensor carriage in a plurality of directions. For example, an electric drive system may drive the sensor carriage in one or more back and forth movements in order to obtain a plurality of measurements at one or more specific locations. For example, the sensor carriage may be driven by an electric drive system in a direction including a back and forth direction, while the liquid delivery device remains in a fixed position relative to the cover device, and/or without additional manual intervention.

The method 400 may also include an operation 410 of evaluating an output of the one or more sensors, the output being indicative of a presence of a characteristic of the liquid delivery device. For example, the cap device may include a processor configured to evaluate sensor signals from one or more sensors (e.g., a change in sensor signals indicative of a plunger) and determine a corresponding position. In some embodiments, operation 410 may include storing the corresponding locations and comparing the corresponding locations during a subsequent capping event. Evaluating the sensor signal may include evaluating the change in position to determine a volume of a previous dose delivery (e.g., by evaluating a distance traveled by the plunger), a volume remaining within the liquid delivery device, or other characteristics of the liquid delivery device.

In some embodiments, the method 400 may include an operation 412 of outputting information related to the plunger position. The information may be output by the cover device and/or transmitted to one or more remote devices. For example, operation 412 may include displaying the previously delivered dose. Alternatively or additionally, operation 412 may include displaying dose information related to a total volume of liquid remaining in the reservoir of the liquid delivery device, dose information related to a number of doses remaining in the reservoir of the liquid delivery device, dose information related to a duration remaining before the reservoir of the liquid delivery device is emptied, dose information related to a time of a previous dose (e.g., a time of receiving operation 402 of the liquid delivery device in the cavity), dose information related to a time elapsed since a last dose (e.g., a time elapsed since receiving operation 402 of the liquid delivery device in the cavity), and/or dose information related to other information related to the liquid delivery device.

In the exemplary embodiment shown, operations 408, 410, and 412 are shown as being performed after at least one of operations 404 and 406. For example, the cap device may detect a physical feature (e.g., plunger) of the liquid delivery device when the liquid delivery device is in proper radial alignment relative to the cap device. When the user has axially inserted the liquid delivery device but fails to rotate it to the radially aligned position (e.g., forgets to do so, is positioned out of alignment, etc.) (e.g., at time a), the cap device may wait until the liquid delivery device is subsequently rotated to the radially aligned position (e.g., at time B) and operate to detect a condition associated with the liquid delivery device. In various exemplary embodiments, the cover device may output information/indicators (e.g., just prior to time B) to prompt the user to move the liquid delivery device to the radially aligned position. For example, the cap device may output information/indicators to prompt the user to move the liquid delivery device to the radially aligned position, even if the cap delivery device engages the liquid delivery device in a misaligned position a few minutes, hours, or days ago, and/or if the display is subsequently turned off (e.g., turned off between time a and time B).

Alternatively, at least one of operations 408, 410, and 412 may be performed before or during at least one of operations 404 and 406. For example, when the liquid delivery device is not radially aligned, the cap device may still be operable to detect a physical feature of the liquid delivery device and then re-run the detection process when the liquid delivery device is rotated to the radially aligned position, thereby updating the previous detection. For example, information related to the state of the liquid delivery device determined at a previous time (e.g., volume of liquid within the reservoir, dose information, volume of previously delivered dose, other information related to the liquid delivery device and its operation) may be updated. In some exemplary embodiments, the cap device may output more information and/or participate in subsequent operations, such as output information related to active insulin determination, recommended correction doses, etc.

In some embodiments, the cap device is operable to record the time of a measurement, detection or other event associated with the liquid delivery device. For example, the cover device may record the time at which the plunger position was detected. In another embodiment, the cap device may record the time before, at the time of and/or after the liquid delivery device is moved to the axially and/or radially aligned position relative to the cap device.

With reference to fig. 5, 6A, and 6B, an exemplary method 500 of detecting engagement and/or alignment of a liquid delivery device with respect to a cap device is described. The method 500 may be used to perform the operation 404 described in fig. 4.

Referring to fig. 5, some embodiments of a method 500 may include an operation 502 of detecting an axially aligned position of an axial insertion of a liquid delivery device into a cap device. In some embodiments, the axially aligned position may be the distal-most end that is insertable into a cavity of a cap device of a liquid delivery device (or in a sleeve 150 (fig. 3) of the cap device). For example, the distal-most wall (e.g., flange wall 158 in fig. 3) may limit axial insertion of the liquid delivery device and define an axially aligned position of the liquid delivery device. In other embodiments, the axially aligned position may be another position within the cap device cavity, such as one or more axial positions between the distal-most end and the opposite open end of the cavity (or in the sleeve 150 (fig. 3) of the cap device).

In operation 502, detecting axial alignment of the liquid delivery device may include detecting axial insertion and securing of the cap device to the liquid delivery device, regardless of whether the cap device is radially aligned.

In other embodiments, operation 502 may be optional and the cap device is not operated to detect an axial position of the liquid delivery device relative to the cap device.

The method 500 may include an operation 504 of activating the cover device. In some embodiments, the cap device automatically switches from an inactive or low power state to an active or operational state when the liquid delivery device is engaged with the cap device and/or the liquid delivery device is disposed in a predetermined axially aligned position. Engagement between the liquid delivery device and the cap device and/or activation of the cap device based on the engagement may serve as an indicator that the liquid delivery device is in an axially aligned position. The cap device may be configured to activate automatically when the liquid delivery device is at least partially inserted into the cap device, regardless of the axial and/or radial position of the liquid delivery device. In some embodiments, the cap device is automatically activated upon determining that the liquid delivery device is disposed in the axially and radially aligned positions. Alternatively or additionally, the cover device is manually activated by a user via a user input device (e.g., a power button).

The method 500 may include an operation 506 of providing a first feedback to indicate that the liquid delivery device is in the axially aligned position. For example, the first feedback may be mechanical feedback generated by a resistive spring force from the axial position device. The axial position means may be a spring biased in a direction opposite to the direction of insertion of the liquid delivery means and configured to engage a portion of the liquid delivery means when the liquid delivery means is axially inserted into the cap means. After the liquid delivery device first interacts with (e.g., contacts) the axial position device, the liquid delivery device may be further inserted to push against the biasing force of the axial position device to a point (e.g., to a predetermined axial alignment position). Such interaction may cause mechanical feedback (e.g., a clicking feel) through the liquid delivery device and/or the cap device, and the feedback may be felt by a user holding the liquid delivery device and/or the cap device, e.g., by a finger. Examples of detecting axial position and providing feedback are described in U.S. patent No. 8,743,662 and U.S. provisional application No. 62/667,085, the disclosures of which are incorporated herein in their entirety to the appropriate extent.

Alternatively or additionally, the first feedback may be generated in other ways. The first feedback is electronically generated and output in various formats (e.g., visual and/or audible formats), for example, via a display device and/or speaker in the cover device.

The method 500 may include an operation 508 of detecting a radial position of the liquid delivery device relative to the cap device. As shown in fig. 6A and 6B, the liquid delivery device may be arranged in a radially aligned position with respect to the cap device in two steps. For example, the liquid delivery device may be axially inserted into an axially aligned position relative to the cap device (step 1 in fig. 6A) and then at least partially rotated relative to the cap device (step 2 in fig. 6B). The cap device may include one or more sensors for detecting when the cap device is in a predetermined radial alignment and determining whether the liquid delivery device is in a radially aligned position relative to the cap device. In some embodiments, this detection may be accomplished by one or more sensors supported by the sensor bracket and configured to detect a state of the liquid delivery device, such as the position and movement of a plunger in the liquid delivery device. In other embodiments, the cover device may be provided with other sensors located at fixed positions on the cover device body and/or dedicated to radial position detection. Additionally, sensors in the cap device may be used to track the radial position of the liquid delivery device. Embodiments of operation 508 are further described below with reference to fig. 6A and 6B.

The method 500 may include an operation 510 of determining whether the liquid delivery device is in a radially aligned position. If the fluid delivery device is determined to be in a radially aligned position ("yes") (e.g., at one or more predetermined radially aligned positions, ranges or locations, etc.), the method 500 may proceed to operation 512. Otherwise ("no"), the method 500 may continue with operation 516 described below.

The method 500 may include an operation 512 of providing a second feedback to indicate that the liquid delivery device is in the radially aligned position. The second feedback may be mechanical feedback generated by a mechanical structure provided by the liquid delivery device and/or the cap device. Such mechanical structures may include mechanical detents, snaps, and other suitable mechanical interactions. For example, the cap means comprises one or more detents formed in the sleeve which are engageable with one or more corresponding projections formed in the liquid delivery device when the liquid delivery device is rotated to the radially aligned position. When the liquid delivery device is rotated to the radially aligned position, the protruding member of the liquid delivery device slides into the catch of the cap device. When the protrusion of the liquid delivery device is inserted (e.g., snapped into) the catch of the cap device, a mechanical feedback (e.g., clicking feel) is generated and the mechanical feedback passes through the cap device and/or the liquid delivery device. The feedback may be felt by a user holding the liquid delivery device and/or the cover device, e.g. by fingers. An exemplary configuration for generating the second feedback is further detailed and described below with reference to fig. 8.

Alternatively or additionally, the second feedback may comprise other feedback. The second feedback is electronically generated and output in various formats (e.g., visual and/or audible formats), for example, via a display device and/or speaker in the cover device.

The method 500 may include an operation 514 of presenting information indicative of the liquid delivery device being in a radially aligned position. Such information may be presented to indicate to a user that the liquid delivery device is properly engaged with the cap device (e.g., for storage, subsequent operation, etc.). Information may be output in various formats. In some embodiments, the display device of the cap device may display one or more symbols (e.g., symbols, text, letters, numbers, etc.) that indicate that the liquid delivery device is radially aligned with the cap device. For example, as shown in fig. 6B, a check mark may be displayed to confirm radial alignment of the liquid delivery device. For example, other formats for outputting information may include audible output via a speaker in the cover device or tactile output via a vibrator in the cover device.

The method 500 may include an operation 516 of presenting information indicative of a radial misalignment of the liquid delivery device. Such information may be used to assist the user in taking steps to remedy the misalignment, such as further rotating the liquid delivery device radially with respect to the cap device until the information disappears or until the user identifies a second feedback indicating the radial alignment position.

In some embodiments, in operation 516, if the radial misalignment remains beyond a threshold period of time, the cap device may be configured to attempt to detect the position of the plunger. For example, when determining radial misalignment in order to continue to detect the radial position of the cap device, the cap device may measure the position at which the plunger is located to see if it is able to determine the amount of dose or the amount of remaining content, even though this may be inaccurate. As described herein, such potentially inaccurate measurements may be updated when the cap device is later determined to be in radial alignment where accurate measurements may be obtained.

In operation 516, the information may be presented in various formats. In some embodiments, the display device of the cover device may display one or more symbols (e.g., signs, text, letters, numbers, etc.) designed to indicate a misalignment state of the liquid delivery device. For example, as shown in fig. 6A, one or two arrow marks may be displayed to indicate the steps taken to place the liquid delivery device in an aligned position relative to the cap device. Other formats are possible for outputting the information, such as audible output via a speaker in the cover device or tactile output via a vibrator in the cover device.

Referring now to fig. 6A and 6B, in some embodiments, the liquid delivery device may be inserted and placed in an aligned position in a series of steps (e.g., two steps). In a first step (step a) (fig. 6A), the liquid delivery device 200 may be at least partially axially inserted into the cap device 100 in any orientation. In a second step (step B) (fig. 6B), the liquid delivery device 200 may be rotated until the liquid delivery device 200 is in a radially aligned position.

In step a, in some embodiments, the cap device 100 includes structure (e.g., the axial position device 300) that provides feedback (e.g., a mechanical click feel) when the liquid delivery device 200 is inserted into a predetermined axial position. The predetermined axial position may be a position where the liquid delivery device 200 is fully inserted into the cap device (e.g., at least partially inserted into the cap device as allowed by the structure of the liquid delivery device and/or the cap device). For example, as shown in fig. 3, the sleeve 150 of the cap device 100 includes a flange wall 158, the flange wall 158 being configured to engage the front end 208 of the liquid delivery device 200 and limit axial movement of the liquid delivery device 200 within the cap device 100. The feedback may confirm that the liquid delivery device 100 is in the proper axial position (e.g., fully inserted) and that the liquid delivery device is ready to be rotated to the radially aligned position in step B.

In step a, the liquid delivery device 100 may be axially inserted in any radial orientation. The liquid delivery device 100 that has been axially inserted into the cap device is not in the radially aligned position unless the liquid delivery device 100 is directed to the radially aligned position relative to the cap device just prior to the axial insertion.

In some embodiments, the cover device 200 may be automatically switched from an inactive or power saving state to an active or powered state when the liquid delivery device 100 is in the axially aligned position. In other embodiments, the cap device 200 may be manually accessed regardless of the axial and/or radial position with the liquid delivery device 100.

In step B, the liquid delivery device 200 may be radially rotated until a radially aligned position is reached. In some embodiments, the cap device 100 includes structure (e.g., detent and protrusion arrangement) that provides feedback (e.g., a mechanical click feel) when the liquid delivery device 200 is in a predetermined radial position. The predetermined radial position may be an orientation of the liquid delivery device relative to the cap device that does not obstruct the view from the sensor in the cap device, thereby facilitating the sensor to clearly detect the state of the liquid delivery device, such as the position and/or movement of the plunger of the liquid delivery device. As shown in fig. 8, cap device 100 includes one or more detents 802 radially disposed on an inner surface of sleeve 150, and liquid delivery device 200 includes one or more protrusions 804 radially disposed on an exterior of liquid delivery device 200 and configured to complement detents 802 of cap device 100. When the liquid delivery device 200 is inserted into an axially aligned position relative to the cap device 100, the detents 802 and the protrusions 804 are arranged in axial alignment. When detents 802 and protrusions 804 are axially aligned and not radially engaged, this means that liquid delivery device 200 is not radially aligned at the time of axial alignment, and liquid delivery device 200 may be rotated until protrusions 804 of liquid delivery device 200 engage detents 802 of cap device 100, thereby maintaining liquid delivery device 200 in a radially aligned position.

One or more characteristics of the liquid delivery device 200 may be detected to determine that the liquid delivery device 200 is in a radially aligned position relative to the cap device 100. In some embodiments, as depicted in fig. 6A and 6B, the liquid delivery device 200 has one or more windows 220 formed on the reservoir 201. In an exemplary embodiment, the liquid delivery device 200 has two windows 220 disposed on opposite sides of the reservoir 201. Window 220 may extend longitudinally along reservoir 201, having opposite axial edges 222 and 224. For example, the distal edge 222 of the window 220 (or a chamfer formed at the distal edge 222) may be used as a reference feature that a sensor in the cap device 100 should detect to verify the radial alignment of the liquid delivery device 200 relative to the cap device 100. As shown in fig. 6A, when the liquid delivery device 200 is axially inserted, the distal edge 222 of the window 220 is not within the field of view of the sensor 142 of the cap device 100, and thus the sensor 142 generates a sensor signal indicative of misalignment between the distal edge 222 and the field of view of the sensor 142. However, as shown in fig. 6B, when the liquid delivery device 200 is rotated radially and the distal edge 222 falls within the field of view of the sensor 142, the sensor signal generated from the sensor 142 changes (e.g., signal drops), which indicates that the distal edge 222 is aligned with the field of view of the sensor 142. If the fluid delivery device 200 is rotated further beyond the radial alignment position, the sensor signal from the sensor 142 will change back to the same or similar signal as that generated when the sensor 142 is not aligned with the distal edge 222 of the window 220, as shown in FIG. 6A.

Fig. 7 is a partial cross-sectional view of the cap device 100 and the liquid delivery device 200, showing predetermined features of the liquid delivery device 200 detected by the cap device sensor when the liquid delivery device 200 is engaged with the cap device 100 in an aligned position. In this figure, the sensor 142 of the cap device 100 detects the distal edge 222 of the window 220 of the liquid delivery device 20, which indicates that the liquid delivery device 200 is in radial alignment with respect to the cap device 100. For example, a distal edge 222 of a window 220 formed in the reservoir 201 of the liquid delivery device 200 is aligned with the field of view 142c of the sensor 142 such that the sensor signal generated by the sensor 142 (e.g., signal drop) is different from the sensor signal generated by the sensor 142 when other features are located within the field of view 142c of the sensor 142 (e.g., outside of the reservoir 201 and not the window 220).

Other types of sensors 142 may be used to detect the radial alignment of the liquid delivery device. In an exemplary embodiment, the sensor may be an Infrared (IR) reflected beam sensor configured to reflect an IR beam to a position proximate the surface to detect a chamfer on the distal edge 222 of the window 220 when the liquid delivery device is in the proper radial position. The sensor includes a transmitter and a receiver disposed on the same side relative to the reservoir. The emitter emits an IR light beam that passes through the reservoir and then reflects from a mirror disposed on the other side of the emitter, and the receiver receives the reflected light beam that returns through the reservoir. Signal distortion due to the window may indicate proper alignment of the fluid delivery device.

Additionally or alternatively, the sensor may be an IR end beam sensor. The emitter of the sensor may inject an IR beam into the distal end of the liquid delivery device and the receiver detects the energy emitted from the chamfer of the reservoir window. The receiver may use geometric filtering to discriminate the signals.

Additionally or alternatively, the sensor is arranged to utilize a window recess. For example, the emitter of the sensor emits a penetrating beam IR signal near the tangent of the reservoir barrel. When the liquid delivery device is in a proper radial alignment, the window of the reservoir provides a recess having a predetermined width that can provide a discernable signal.

Additionally or alternatively, the sensor is configured to scan the reservoir and/or other portion of the liquid delivery device. For example, sensors are used to perform a half scan to detect different features, such as text, markings, window frames, etc., that may indicate misalignment of the liquid delivery device. If a misalignment feature is detected by scanning, the user may be required to rotate the liquid delivery device until the liquid delivery device snaps into place. Such rotation may be detected by an accelerometer or similar component in the cover device, and the half scan may be run again to confirm that no misalignment feature is detected.

Additionally or alternatively, the cap means comprises a flexible member which is interactable with the reservoir outer surface of the liquid delivery device. The flexibility of the component will cause the component to change its shape in accordance with the portion of the reservoir with which the component interacts. The flexible member may be associated with a physical switch that operates to detect different movements and/or shapes of the member relative to the reservoir of the liquid delivery device.

Additionally or alternatively, the sensor has an emitter configured to emit an IR beam at a low angle onto the reservoir or other portion of the liquid delivery device. When the liquid delivery device rotates inside and outside the window area, the reflection will transition from plastic to glass, or vice versa, with the surface of the liquid delivery device. Only the light beam reflected by the glass reaches the receiver of the sensor.

Fig. 8 is a partial cross-sectional view of the cap device 100 and the liquid delivery device 200, showing an exemplary radial retention structure 800 that removably retains the liquid delivery device 200 and/or generates mechanical feedback to confirm radial alignment of the liquid delivery device 200 relative to the cap device 100. Referring to fig. 3 and 8, in some embodiments, a portion of the radial retention structure 800 is disposed in the sleeve 150. The radial retention structure 800 may include one or more detents 802 formed on an inner surface of the sleeve 150. In some embodiments, sleeve 150 has detents 802 that provide a single radial alignment for liquid delivery device 200. In other embodiments, a plurality of detents 802 may be radially disposed on the inner surface of sleeve 150 to provide a plurality of radially aligned positions for liquid delivery device 200. The plurality of detents 802 may be equally spaced (i.e., at the same angular distance) along the circumference of the inner surface of the sleeve 150. In other embodiments, at least one of the plurality of detents 802 may be spaced apart at different angular distances.

The radial retention structure 800 may also include one or more protrusions 804 formed on the liquid delivery device 200. The liquid delivery device 200 includes one or more protrusions 804, which one or more protrusions 804 are configured to embed (e.g., snap into) the detents 802 of the cap device 100 when the liquid delivery device 200 is at least partially received in the cap device 100. Catch 802 and/or projection 804 are arranged to engage one another when liquid delivery device 200 is in an aligned position (e.g., an axial and/or radial aligned position) relative to cap device 100.

In an exemplary embodiment, the liquid delivery device 200 includes two protruding members 804, each protruding member 804 being disposed on an outer surface of the reservoir 201. For example, each tab 804 extends from an outer surface of the reservoir 201 proximate the proximal edge 224 of the window 220 and is axially aligned with the distal edge 222 of the window 220. In other embodiments, the protrusion 804 may be in other locations.

The sleeve 150 is sized to axially receive the liquid delivery device 200 in any orientation. In some embodiments, the sleeve 150 is sized to accommodate at least the reservoir 201 of the liquid delivery device 200. For example, the Inner Diameter (ID) of sleeve 150 is sized to be substantially the same as (with appropriate clearance from) or greater than the Outer Diameter (OD) of reservoir 201 containing protrusion 804. Thus, the sleeve 150 may receive the reservoir 201 of the liquid delivery device 200 in any orientation.

The cover device 100 may include one or more ridges (or ramps) 806 formed on the inner surface of the sleeve 150. The ridges 806 provide a portion that protrudes from the Inner Diameter (ID) of the sleeve 150 so that detents 802 may be formed in the ridges 806. The ridges 806 allow detents 802 to be formed in the inner surface of the sleeve 150 while having an Inner Diameter (ID) of the sleeve 150 sufficient to accommodate an Outer Diameter (OD) of the reservoir 201 of the liquid delivery device 200 inserted axially in an orientation in which the protrusions 804 are disposed out of alignment with the ridges 806.

When the protruding member 804 begins to engage the ridge 806 by rotating the liquid delivery device 200 relative to the cap device 100, the ridge 806 (or the portion of the sleeve 150 that includes the ridge 806) and/or the protruding member 804 (or the portion of the liquid delivery device 200 that includes the protruding member 804) may flex, which allows the protruding member 804 to slide along the ridge 806 until the protruding member 804 enters the catch 802.

Radial retention structure 800 may also include one or more axial stops 808 that prevent projection 804 from inadvertently disengaging catch 802. Axial stop 808 may include a flange formed in catch 802 and configured to engage protrusion 804 and prevent protrusion 804 from sliding axially off catch 802 (in an axial direction opposite the direction in which liquid delivery device 200 is inserted into cap device 100) in the absence of an axial force sufficient to pull liquid delivery device 200 out of cap device 100 (e.g., a force exceeding a predetermined threshold force value).

Cover device 100 may also include one or more axial openings 810 extending from catch 802 to allow projection 804 to axially disengage catch 802. Axial opening 810 is formed to extend from catch 802 in an axial direction opposite to the direction in which liquid delivery device 200 is inserted into cap device 100. Axial opening 810 is configured to allow protrusion 804 to slide out of catch 802 when liquid delivery device 200 is pulled axially from cap device 100 with a force exceeding a predetermined threshold force value. Axial stop 808 may be disposed between detent 802 and axial opening 810 and function as a tab in the process from detent 802 to axial opening 810.

In some cases, axial opening 810 may serve as an entrance for projection 804 into detent 802 when liquid delivery device 200 is oriented (or intentionally oriented) just prior to insertion of cap device 100 such that projection 804 is aligned with detent 802 of sleeve 150. In this case, the axial force pushing on the liquid delivery device 200 may overcome the resistance from the axial stop 808 and the protrusion 804 may enter the catch 802 without rotating the liquid delivery device 200 relative to the cap device 100. Axial stop 808 may create a mechanical feedback (e.g., a clicking feel) when protrusion 804 is pushed axially into detent 802.

Referring again to fig. 6A and 6B, the display device 121 of the cover device 100 may display various information (e.g., as symbols) to indicate different states of the liquid delivery device 200 and/or the cover device 100. In some embodiments, the display interface 600 of the display device 121 provides a liquid delivery device position description 602 and a liquid delivery device position indicator 604 (including 604A, 604B, and 604C). As shown in fig. 6B, the display interface 600 may further provide battery status 606 and status 608 associated with the liquid delivery device, such as a volume of the dose delivered by the liquid delivery device, a total volume of liquid remaining in the reservoir, a number of doses remaining in the reservoir, a duration of time remaining before the reservoir is emptied, a time of a previous dose (e.g., a time of replacement of the cap device onto the liquid delivery device), a time elapsed since a last dose (e.g., a time elapsed since replacement of the cap device onto the liquid delivery device), and/or other information related to the liquid delivery device.

For example, in a first scenario, where the liquid delivery device 200 remains received in the cap device 100, the display device 121 may display the liquid delivery device state 608 (e.g., the time elapsed since the last dose ("elapsed 3 hours 10 minutes since the last dose" in fig. 6B).

In a second scenario, when the user removes the liquid delivery device 200 from the cap device 100, the display device 121 may change and display the liquid delivery device position description 602 to indicate that the liquid delivery device has been removed (e.g., "cap off pen" in fig. 6A). The display device 121 may further display a first liquid delivery device position indicator and a second liquid delivery device position indicator, such as straight arrow 604A and curved arrow 604B, to guide the step of engaging the liquid delivery device with the cap device in a predetermined alignment position (e.g., axial and/or radial alignment position).

In a third scenario, when the user axially inserts the liquid delivery device 200 and continues to radially rotate the liquid delivery device 200 to a predetermined alignment position (e.g., inserts and rotates the liquid delivery device within a predetermined period of time, such as within 0.5 seconds), the display device 121 may change the display interface 600 to delete the previous description 602 (e.g., "cap off pen") and previous indicators (e.g., straight arrow 604A and curved arrow 604B) and display a third liquid delivery device position indicator, such as check mark 604C, that represents a confirmation that the liquid delivery device 200 is in the predetermined alignment position. The display device 121 may further display the liquid delivery device status 608.

In a fourth scenario, when the user axially inserts the liquid delivery device 200 but does not rotate it to the predetermined alignment position (e.g., inserts the liquid delivery device but forgets to rotate it within a predetermined period of time, such as forgets to rotate it within 0.5 seconds), the display device 121 may continue to display the previous description 602 (e.g., "cap off pen") and/or the first and second indicators, such as the straight arrow 604A and the curved arrow 604B, for a predetermined period of time (e.g., 30 seconds) that has elapsed since the liquid delivery device was axially inserted. After the predetermined period of time, the display device 121 may change the display interface 600 to display another description 602 (e.g., "spin pen") instead of the previous description (e.g., "cap away pen"). The display interface 600 may be further modified to remove the first indicator (e.g., straight arrow) 604A and continue to display the second indicator (e.g., curved arrow) 604B, informing the user that the liquid delivery device still needs to be rotated. When the user rotates the liquid delivery device to the aligned position, the description 602 (e.g., a "rotating pen") disappears and the second indicator (e.g., a curved arrow) 604B is replaced with a third indicator (e.g., a check mark) 604C.

The display scenario described above may be further illustrated in fig. 9, which is a flowchart of an exemplary method 900 for displaying information on the cover device 100. Method 900 is also described with reference to fig. 6A and 6B. The method 900 may be performed at least in part by the cover device 100. The method 900 may include an operation 902 of determining whether the liquid delivery device is at least partially inserted into the cap device. If it is determined that the liquid delivery device is not inserted into the cap device ("NO"), the method 900 proceeds to operation 904. If it is determined that the liquid delivery device is inserted into the cap device ("yes"), the method 900 continues with operation 906.

The method 900 may include an operation 904 of presenting first information indicating that the liquid delivery device has been removed. As described in the second scenario above, the first information may include a description indicating that the liquid delivery device has been removed (e.g., "cap off pen" in fig. 6A). The first information may also include a first indicator and a second indicator, such as straight arrow 604A and curved arrow 604B in fig. 6A, to inform two steps (e.g., insertion and rotation) required to engage the liquid delivery device with the cap device in a predetermined alignment position.

The method 900 may include an operation 906 of determining whether the liquid delivery device is disposed in a predetermined axial position (e.g., an axially aligned position). In some cases, determining whether the liquid delivery device is disposed in the predetermined axial position may be determining whether to use a snap fit between the cap device 100 and the liquid delivery device 200 to properly snap the cap device 100 to the liquid delivery device 200. If it is determined that the liquid delivery device is not disposed at the predetermined axial position ("NO"), the method 900 proceeds to operation 908. Otherwise ("yes"), method 900 continues with operation 910.

The method 900 may include an operation 908 of presenting second information requesting axial and radial movement of the liquid delivery device relative to the cap device. Operation 908 may be performed if the liquid delivery device has not been fully inserted into the cap device, if the liquid delivery device has not been fully inserted to be in the predetermined axial position, or if the liquid delivery device is being inserted but has not been disposed in the predetermined axial position. The second information of operation 908 may include a description of the misalignment of the liquid delivery device (e.g., "cap off pen" in fig. 6A) and/or a first indicator that shows that two steps (e.g., insertion and rotation) are still required, as well as a second indicator, such as straight arrow 604A and curved arrow 604B in fig. 6A.

The method 900 may include an operation 910 of determining whether the liquid delivery device is disposed at a predetermined radial position (e.g., a radial alignment position). If it is determined that the liquid delivery device is not disposed at the predetermined radial position ("NO"), the method 900 proceeds to operation 912. Otherwise ("yes"), method 900 continues to operation 914.

The method 900 may include an operation 912 of presenting third information requesting radial movement of the liquid delivery device relative to the cap device. Operation 912 may be performed if the liquid delivery device has been inserted into a predetermined axial position relative to the cap device but has not been rotated to a predetermined radial position. As described in the fourth scenario above, the third information may include a description 602 requesting rotation of the liquid delivery device (e.g., a "spin pen") and/or a second indicator 604B informing the user to rotate the liquid delivery device relative to the cap device (e.g., a curved arrow).

The method 900 may include an operation 914 of presenting fourth information indicating proper alignment of the liquid delivery device. Operation 914 may be performed if the liquid delivery device has been inserted into a predetermined axial position and rotated to a predetermined radial position. As described in the third scenario above, the fourth information represents a third identifier 604C (e.g., a confirmation check mark) that confirms that the liquid delivery device 200 is in the predetermined alignment position.

In some embodiments, the cap device 100 operates to facilitate dose detection that is not concurrent with dose delivery. The cap device may be configured to detect a condition of the liquid delivery device, such as a plunger position, when the liquid delivery device is in proper radial alignment with respect to the cap device. When the user has axially inserted the liquid delivery device but fails to rotate it to the radially aligned position (e.g., forgets to do so, is positioned out of alignment, etc.) (e.g., at time a), the cap device may wait until the liquid delivery device is subsequently rotated to the radially aligned position (e.g., at time B) and operate to detect a condition associated with the liquid delivery device. In various exemplary embodiments, the cover device may output information/indicators (e.g., just prior to time B) to prompt the user to move the liquid delivery device to the radially aligned position. For example, the cap device may output information/indicators to prompt the user to move the liquid delivery device to the radially aligned position, even if the cap delivery device is engaged with the liquid delivery device in a misaligned position a few minutes, hours, or days ago, and/or if the display is subsequently turned off (e.g., turned off between time a and time B).

Alternatively, the cap means may still be operable to detect the condition of the liquid delivery device when the liquid delivery device is not radially aligned and to re-run the detection process when the liquid delivery device is rotated to the radially aligned position, thereby updating the previous detection. For example, information related to the state of the liquid delivery device determined at a previous time (e.g., volume of liquid within the reservoir, dose information, volume of previously delivered dose, other information related to the liquid delivery device and its operation) may be updated. In some exemplary embodiments, the cap device may output more information and/or participate in subsequent operations, such as output information related to active insulin determination, recommended correction doses, etc.

In some embodiments, the cap device is operable to record a time when the liquid device is axially engaged with the cap device (e.g., also referred to as a misalignment time or an axial alignment time), and a time when the liquid device is radially aligned with respect to the cap device (e.g., also referred to as an alignment time or a radial alignment time). The recorded time may be used to calculate and/or update an accurate determination of a status associated with the liquid delivery device. For example, the cap device may be operable to measure/calculate a liquid dose from the liquid delivery device and record a time (e.g., a misalignment time) when the liquid delivery device is only axially inserted into the cap device but not rotated to a predetermined radial position relative to the cap device. The cap device is operable to identify when the liquid delivery device is moved into a predetermined alignment with the cap device (e.g., an alignment time), and is further operable to measure/calculate a liquid dose delivered from the liquid delivery device at a previous time and to provide updated, accurate dose information. Such features may help track and output accurate information associated with the liquid delivery device over a period of time.

For example, in some cases, after axial alignment is achieved at time X, the user may ignore placing the cap device 100 and the liquid delivery device 200 in a predetermined radial alignment despite a radial misalignment (e.g., the presence of operation 516 in fig. 5). If a user subsequently removes the cap device 100 from the liquid delivery device 200 (e.g., for subsequent liquid injection) without the cap device 100 and the liquid delivery device 200 being in a predetermined radial alignment, then replaces the cap device 100 onto the liquid delivery device 200 at a time Y in a predetermined axial and radial alignment, the methods, systems, and devices provided herein may determine an approximation of each amount of liquid remaining in the liquid delivery device 200 at times X and Y. In some cases, if the cap device 100 performs a status detection operation (e.g., one or more of operations 408, 410, and 412) after the cap device 100 and the liquid delivery device 200 are out of a predetermined radial alignment at time X, a potentially inaccurate estimate of the amount of liquid remaining may be used within time X. If no status detection operations (e.g., operations 408, 410, and 412) are used between times X and Y, or if no approximation can be made, the method, system, and apparatus may determine the position of the plunger at time Y and infer the position of the plunger at time X based on the user's glycemic response at times before and after times X and Y, based on the user's historical dose at times X and Y, based on the user's therapeutic parameters, or any other information that may be approaching the dose. In some cases, the methods, systems, and devices provided herein can query the user for the amount of dose at time X.

While this specification contains many specifics of specific embodiments, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In some cases, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, but rather, it should be understood that the described program components and systems can be generally integrated together in a single software product or packaged into multiple software products.

Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the acts recited in the claims can be performed in a different order and still achieve desirable results. Additionally, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain embodiments, multitasking and parallel processing may be advantageous.

Claims

1. A cover device for a liquid delivery device, characterized in that the cover device comprises:

a body defining a cavity configured to at least partially receive a fluid delivery device; and

A first sensor is configured to output a sensor signal indicative of a radially aligned position of the fluid delivery device relative to the body when the fluid delivery device is at least partially received within the cavity of the body.

2. The cover device according to claim 1, characterized in that the cover device further comprises:

a second sensor configured to output a sensor signal indicative of a plunger of the fluid delivery device; and

A processor configured to:

determining that the fluid delivery device is not in the radially aligned position at a first time;

determining that the fluid delivery device is in the radially aligned position at a second time later than the first time;

determining a position of the plunger at the second time using the second sensor; and

Based at least in part on the position of the plunger at the second time, an approximate position of the plunger at the first time is calculated.

3. The cap device of claim 2, wherein the approximate position of the plunger at the first time is further based on at least one of a user's glycemic response, a user's historical dosing, and a user's therapeutic parameters.

4. The cover device according to any one of claims 1 to 3, characterized in that the cover device further comprises a processor, the processor being configured to detect the radial alignment position of the liquid delivery device based on the sensor signal of the first sensor, and

A sensor bracket is movable between a first position and a second position within the cavity when the fluid delivery device is in a fixed position relative to the cavity.

5. The cap device of claim 1, wherein the first sensor is configured to output a sensor signal indicative of a radial alignment position when the first sensor is located at a predetermined axial position along the liquid delivery device.

6. The cover device of claim 4, wherein the first sensor is located on the sensor bracket.

7. The cover device according to any one of claims 4 to 6, characterized in that the cover device further comprises a second sensor, and the second sensor is located on the sensor bracket.

8. The cap device according to claim 7, characterized in that the second sensor is configured to output a sensor signal indicative of the plunger of the liquid delivery device during movement of the sensor bracket between the first position and the second position, and/or

The cover device further comprises a motor configured to move the sensor bracket between the first position and the second position, wherein the sensor bracket mounts the first sensor, and wherein the motor operates to move the sensor bracket to a predetermined axial position, wherein the first sensor is arranged to detect a radially aligned position of the liquid delivery device, and/or

wherein the processor is configured to determine a state associated with the liquid delivery device based on the sensor signal of the first sensor and the sensor signal of the second sensor, wherein the state associated with the liquid delivery device comprises at least one of: a dose volume delivered by the liquid delivery device, a total volume of liquid remaining in the liquid delivery device, a number of doses remaining in the liquid delivery device, a duration remaining before the liquid delivery device is emptied, and a time of a previous dose, a time elapsed since a previous dose, and/or

The processor is configured to record a first time when the liquid delivery device is axially received in the cavity of the body and a second time when the liquid delivery device is moved to the radially aligned position, and determine a state associated with the liquid delivery device based on the sensor signal of the first sensor, the sensor signal of the second sensor, the first time, and the second time, and/or

The second sensor includes a second light emitter and a second light receiver defining an optical path therebetween, wherein the second sensor is operative to detect the physical characteristic of the fluid delivery device by outputting a sensor signal indicative of the physical characteristic.

9. The cap device of claim 4, wherein the first sensor comprises a first light emitter and a first light receiver, a light path being defined between the first light emitter and the first light receiver, wherein the first sensor operates to detect the physical characteristic of the liquid delivery device by outputting a sensor signal indicative of the physical characteristic,

The cover device further comprises a position sensor configured to detect an axial position of the sensor bracket within the body,

The physical feature of the fluid delivery device includes a plunger of the fluid delivery device, and wherein the processor is operative to detect the plunger of the fluid delivery device based on a change in the sensor signal and to determine a corresponding position of the plunger based on the sensor signal output by the position sensor.

10. The cover device according to any one of claims 1 to 9, characterized in that the cover device further comprises:

An axial position device is configured to engage the fluid delivery device axially inserted into the cavity of the body and generate a first mechanical feedback when the fluid delivery device engages the axial position device.

11. The cap device of claim 10, wherein the axial position device comprises a sensor configured to generate a sensor signal indicative of engagement of the liquid delivery device with the axial position device.

12. The cover device according to any one of claims 1-11 is characterized in that the main body is configured to axially receive at least a portion of the liquid delivery device in the cavity, and the liquid delivery device can at least partially rotate relative to the main body while at least a portion of the liquid delivery device is in the cavity.

13. The cap device of claim 4, further comprising a sleeve configured to receive at least a portion of the liquid delivery device, wherein the sensor bracket is configured to move along an outer side of the sleeve.

14. The cover device according to any one of claims 1 to 13, characterized in that the first sensor is fixedly mounted on the main body.

15. A method for operating a cover device of a liquid delivery device, characterized in that the method comprises:

detecting a radial position of the liquid delivery device relative to a body of the cover device while the liquid delivery device is at least partially within the cover device; and

Information related to the radial position of the fluid delivery device is output.

16. The method according to claim 15, characterized in that the method further comprises:

Prior to detecting the radial position, detecting engagement of the liquid delivery device with the cover device, the liquid delivery device being rotatable relative to a body of the cover device, and

activating the cover means when the liquid delivery means moves to a predetermined axial alignment position, and/or

The information indicates whether the radial position of the liquid delivery device is moved to the predetermined radial alignment position,

The method further comprises:

generating a second mechanical feedback when the radial position of the fluid delivery device moves to the predetermined radial alignment position,

detecting a first time that the fluid delivery device is axially engaged within the cavity of the body;

detecting a second time when the liquid delivery device is in the predetermined radial alignment position;

detecting a characteristic associated with the fluid delivery device using a sensor; and

determining a state associated with the fluid delivery device based on the characteristic, the first time, and the second time, and/or

The method further comprises:

A first mechanical feedback is generated when the fluid delivery device moves to a predetermined axial alignment position.

17. The method according to claim 15, characterized in that the method further comprises:

determining that the liquid delivery device is not radially aligned with the body of the cap device at a first time;

determining that the liquid delivery device is radially aligned with the body of the cap device at a second time later than the first time;

determining a position of the plunger at the second time; and

calculating an approximate position of the plunger at the first time based at least in part on the position of the plunger at the second time,

Wherein the approximate position of the plunger at the first time is further based on at least one of a user's glycemic response, a user's historical dosage, and a user's treatment parameter.

18. The method according to any one of claims 15 to 17, wherein detecting the radial position of the liquid delivery device comprises:

receiving a sensor signal from a first sensor indicative of a radially aligned position of the liquid delivery device relative to a body of the cap device,

The method further comprises:

A sensor carrier including the first sensor is driven to a predetermined axial position within the cover device, wherein the first sensor is configured to generate a sensor signal indicative of the radial alignment position when the sensor carrier is arranged at the predetermined axial position.

19. The method according to claim 18, characterized in that the method further comprises:

driving a sensor bracket including a second sensor between a first position and a second position within the body of the cap device when detecting the radial position of the liquid delivery device; and

detecting a physical characteristic of the fluid delivery device while the sensor holder moves between the first position and the second position,

Wherein, detecting the physical characteristics of the liquid delivery device includes:

A sensor signal indicative of a plunger of the fluid delivery device is received from the second sensor during movement of the sensor bracket between the first position and the second position.