Wearable electronic devices, systems, and methods for collecting patient motion data and assessing patient activity

Abstract

A wearable electronic device includes a light sensor configured to sense ambient light, a timer providing a time indicator, a motion sensing unit that senses motion and outputs motion data in dependence on the sensed motion, and a data storage that receives and stores the motion data or other data derived therefrom in association with the time indicator. The timer starts providing the time indicator and the motion sensing unit starts sensing motion after ambient light is sensed by the light sensor.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Application No. 63 / 018,012, filed April 30, 2020, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention relates to assessing patient activity, and more specifically, to objectively assessing patient activity using patient motion data. Background Technology

[0004] Physicians frequently prescribe pain interventions for patients to manage pain, such as pain associated with chronic diseases or post-operative care. To assess the effectiveness of pain interventions, physicians often rely on patient feedback. However, patient feedback is subjective and can therefore be an unreliable and / or inaccurate indicator of the effectiveness of pain interventions. Summary of the Invention

[0005] This article discloses implementations of wearable electronic devices, systems, and methods for assessing patient activity.

[0006] In one embodiment, a wearable electronic device is provided for collecting motion data from a patient to assess their activity. The wearable electronic device typically includes a motion sensing unit, a data storage device, a communication interface, a power supply, and an electronic device housing. The motion sensing unit senses motion and outputs motion data based on the sensed motion. The data storage device receives and stores the motion data. The communication interface is used to transmit motion data from the data storage device. The electronic device housing is configured to be worn by the patient. To transmit motion data from the data storage device or to physically access one or more of the power supplies, the electronic device housing must be permanently deformed.

[0007] In one embodiment, a wearable electronic device is provided for collecting motion data from a patient. The wearable electronic device typically includes a motion sensing unit, a data storage device, a communication interface, a controller, and a power supply. The motion sensing unit includes one or more sensors for sensing motion and outputting motion data based on the sensed motion. The data storage device receives and stores the motion data. The communication interface is used to transmit motion data from the data storage device. The controller operates the motion sensing unit and the data storage device. The wearable electronic device does not include any output device through which the patient can directly observe the output of the wearable electronic device, nor does it include any input device through which the patient can directly provide conscious input to the wearable electronic device.

[0008] In one embodiment, a method for assessing the activities of multiple patients is provided. The method includes: (1) distributing one or more wearable electronic devices from a plurality of wearable electronic devices to each of the one or more patients for wear; (2) collecting motion data of the patient through each of the plurality of wearable electronic devices while the wearable electronic devices are being worn; (3) receiving each of the plurality of wearable electronic devices from the patient at a processing facility; and (4) transmitting the motion data from each of the plurality of wearable electronic devices through a computer data system associated with the processing facility.

[0009] In one embodiment, a wearable electronic device includes: a light sensor configured to sense ambient light; a timer providing a time indicator; a motion sensing unit that senses motion and outputs motion data based on the sensed motion; and a data storage device that receives and stores the motion data or other data derived therefrom in association with the time indicator. After ambient light is sensed by the light sensor, the timer begins to provide a time indicator, and the motion sensing unit begins to sense motion.

[0010] After light is detected by the light sensor, the timer can continue to provide a time indicator until data is subsequently transferred between the data storage device and the computing device. The wearable electronic device may also include a proximity sensor, which can begin operating to sense a patient wearing the wearable electronic device after ambient light is detected by the light sensor. After a patient wearing the wearable electronic device is detected, a motion sensing unit can begin sensing motion. The proximity sensor can begin operating to sense a patient wearing the wearable electronic device in response to ambient light being detected by the light sensor. The motion sensing unit can begin sensing motion in response to the detection of a patient wearing the wearable electronic device. Recording motion data can stop in response to the light sensor not detecting ambient light and the motion sensing unit not detecting motion. The wearable electronic device may include a power source, which can begin supplying power to the motion sensing unit after ambient light is detected by the light sensor. The power source can begin supplying power to the proximity sensor after ambient light is detected by the light sensor. The wearable electronic device may include a controller that includes a timer. The wearable electronic device may include a proximity sensor, and a controller may activate a motion sensing unit to begin sensing motion when a patient wearing the wearable electronic device is detected by the proximity sensor. The wearable electronic device may include a light source that outputs light at 10 lumens or less. The wearable electronic device may include a communication interface through which motion data can be transferred from a data storage device to a computing device. The data storage device may store additional data, namely the root mean square of motion data from each of the three axes of the motion sensing unit. The wearable electronic device may include a housing and flexible circuitry to which a light sensor, a timer, a motion sensing unit, a data storage device, and a proximity sensor are coupled. The flexible circuitry may include two peripheral portions forming electrodes for the proximity sensor, which may be a capacitive sensor, and / or extending around a large portion of the circumference of the inner surface of the housing via the two peripheral portions cooperating with each other, positioning the flexible circuitry within the housing. The housing may be cylindrical. Ambient light can pass through the housing to reach the light sensor.

[0011] In one embodiment, a system may include a wearable electronic device and a package in which the wearable electronic device is positioned, the package being opaque and preventing light from reaching a light sensor. When the wearable electronic device is removed from the package, the light sensor senses ambient light, after which a timer may begin providing a time indicator and a motion sensing unit begins sensing motion. Attached Figure Description

[0012] The invention can be best understood from the following detailed description when read in conjunction with the accompanying drawings. It should be emphasized that, as is customary, the various features in the drawings are not to scale. Instead, for clarity, the dimensions of the various features may be arbitrarily enlarged or reduced.

[0013] Figure 1A This is a side elevation view of a wearable electronic device with hidden components depicted in dashed lines.

[0014] Figure 1B yes Figure 1A A top view of a wearable electronic device.

[0015] Figure 1C It is along Figure 1A The line 1C-1C in the middle is intercepted and is in the first state. Figure 1A A cross-sectional view of a wearable electronic device.

[0016] Figure 1D It is along Figure 1A The line 1D-1D intercepted and in the second state. Figure 1A A cross-sectional view of a wearable electronic device.

[0017] Figure 1E This is a side view of another embodiment of a wearable electronic device.

[0018] Figure 2A yes Figure 1A A schematic diagram of a wearable electronic device.

[0019] Figure 2B This is a schematic diagram of another embodiment of a wearable electronic device.

[0020] Figure 2C yes Figure 2B A schematic diagram of a flexible circuit board for wearable electronic devices.

[0021] Figure 2D It is a 2D-2D section along the line and includes Figure 2C Flexible circuit boards Figure 1E A cross-sectional view of a wearable electronic device.

[0022] Figure 3 yes Figure 1A A schematic diagram of an example controller for a wearable electronic device.

[0023] Figure 4A yes Figure 1A A top view of the wearable electronic device in the packaging.

[0024] Figure 4B It is a section with removable covering taken along line 1C-1C. Figure 1AA cross-sectional view of a wearable electronic device.

[0025] Figure 5 This is a flowchart of the first method for collecting patient motion data.

[0026] Figure 6 This is a schematic diagram of a system used to assess the activities of multiple patients.

[0027] Figure 7 This is a flowchart of a method for assessing the activities of multiple patients. Detailed Implementation

[0028] This document discloses devices, systems, and methods for collecting physiological data. Among other uses, these devices, systems, and methods can provide objective indicators, used alone or in combination with other indicators, to assess the efficacy of pain interventions. In particular, theoretically, patient activity can indicate the efficacy of pain interventions; for example, a higher level of activity indicates better efficacy of the pain intervention. Patient activity can be assessed based on motion data measured using an accelerometer.

[0029] In one embodiment, the device can be configured as a wearable electronic device that collects motion data and is dispensed to a patient according to a prescription for a specified period of wear. The device can also be configured as a time-limited (e.g., disposable) device, limited by the period the patient wears it for, and this limitation can be imposed by restricting power capacity, data storage capacity, and / or the way the patient interacts with the device (e.g., the patient cannot transmit or otherwise access motion data). The patient delivers the device to a processing facility, which processes the device to transmit and evaluate the collected motion data, generates an assessment of the activity based on the motion data, and sends it to the prescriber. In some embodiments, the processing facility can also restore the device's electronics for reuse in the same or another device. Processing facilities can be centrally or regionally located to ensure short transport times.

[0030] As discussed in further detail below, wearable electronic devices can be configured to avoid affecting patient behavior and can be configured to present few and / or very low barriers to use for patients and prescribers (e.g., physicians) (e.g., few user commands, no electronic interaction, and / or no additional equipment). To avoid affecting patient behavior, for example, wearable electronic devices can be configured to receive little or no patient input, provide little or no output to the patient, and be physically compact and lightweight. To present few or very low barriers to use, for example, wearable electronic devices can be configured to require only minimal or no maintenance from the patient or prescriber (e.g., by not requiring charging, not requiring electronic interaction for updates, and / or being set as single-use devices), and require only minimal or no electronic interaction from the patient or prescriber (e.g., by not requiring electronic equipment to initiate the recording, transmission, or processing of motion data).

[0031] As discussed in further detail below, systems and methods are provided for collecting motion data from one or more patients using one or more wearable electronic devices. The systems and methods are configured to present few and / or very low barriers to use for both patients and prescribers, while also providing a low-cost system for collecting motion data from multiple different patients (e.g., thousands of patients) and assessing the activity of multiple different patients. In addition to the aspects described above, various electronic components of the wearable electronic devices can be configured to be reusable, and the systems and methods can include processing facilities for processing these wearable electronic devices to assess motion data. Furthermore, in some embodiments, the systems and methods can be used to create new single-use devices from electronics from other wearable electronic devices within these wearable electronic devices.

[0032] refer to Figure 1A As shown in Figure 2, the wearable electronic device 100 typically includes a body 110 and electronics 120 coupled to the body 110. The body 110 is configured to be worn by a patient, for example, on the patient's wrist, and the body 110 typically includes a housing portion 112 and a coupling portion 114. The electronics 120 is configured to collect the patient's physiological data, such as motion data. Figure 2A As schematically illustrated, electronic device 120 includes, for example, one or more motion sensing units 230, a controller 240, a data storage device 250, a power supply 260, and a communication interface 280, which can be coupled to substrate 290 and form an electronic device module. In some embodiments, electronic device 120 may also include other components, such as proximity sensor 270.

[0033] The body 110 is configured to be worn by a patient, for example, on the patient's wrist, so that the electronics 120 moves with the patient to sense the patient's movement. The body 110 typically includes a housing portion 112 and a connecting portion 114.

[0034] The housing portion 112 is coupled to the electronic device 120. For example, the housing portion 112 may include or form an electronic device housing 112a that defines a chamber for receiving the electronic device 120 and may also be sealed to prevent water from reaching the electronic device 120. The electronic device housing 112a may have a greater thickness and / or a greater width than the coupling portion 114 to receive the electronic device 120 placed therein.

[0035] Wearable electronic device 100 can be configured as a wrist-worn device (e.g., a strap), in which case the connecting portion 114 is elongated and extends from the housing portion 112 around the patient's wrist. As shown, the length of the body 110 can be adjustable, and the connecting portion 114 has two strap portions 114a, 114b that extend from each side of the housing portion 112 and can be connected to each other (e.g., by a snap or other suitable connecting mechanism). Alternatively, the connecting portion 114 can be continuous, only elastically adjustable to the size of the patient's wrist.

[0036] In another alternative, the wearable electronic device 100 may be configured to connect to the user in other ways, in which case the connection portion 114 may be configured as a hook or clip (e.g., attached to the user's clothing) or an adhesive (e.g., attached to the user's skin or clothing).

[0037] Body 110 is configured to conform to the patient. Body 110 may be flexible and elastic to hold electronics 120 in a position very close to the user and to provide a comfortable wearing experience for the user. For example, housing portion 112 may include a flexible material layer and / or an elastic (e.g., compressible) material layer, such as an elastomeric material (e.g., silicone), disposed between electronics 120 (e.g., a module of electronics 120) and the patient, and may conform to the patient by bending around the patient and / or by compression. The two strap portions 114a, 114b of connecting portion 114 may be formed of flexible and / or elastic materials, such as an elastomeric material (e.g., silicone), which may conform to the patient by bending around the patient and / or by elastic extension (e.g., when the patient moves their wrist). The housing portion 112, including the electronic device housing 112a, and the connecting portion 114 (e.g., two strip portions 114a, 114b) can be integrally formed with each other (e.g., formed from the same polymeric compound, such as an elastomer (e.g., silicone)). Alternatively, the electronic device housing 112a can be formed from a different material (e.g., plastic), which can be further surrounded (e.g., encapsulated) by the elastomeric material of the housing portion 112, which can be integrally formed with the connecting portion 114.

[0038] The body 110 and housing portion 112, particularly housing portion 112, can be constructed in different ways for different functions associated with the electronics 120, for example, to operate the power supply 260, provide physical access for retrieving motion data from the data storage device 250 and / or access the power supply 260, and / or remove the electronics 120 for reuse in another wearable electronic device 100. In each case, the electronics 120 can be sealed within the electronics housing 112a of housing portion 112 to protect the electronics 120 from water.

[0039] refer to Figure 1C The housing portion 112 can be configured to allow airflow to the power source 260, which can be configured as a metal-air battery that requires air during operation (e.g., to support a reduction reaction). In this case, the housing portion 112 includes a membrane 112b that is waterproof and seals the chamber formed by the electronic device housing 112a, but the membrane 112b is breathable.

[0040] Membrane 112b can be formed in different ways. Membrane 112b may be clearly distinguishable from other parts of body 110, or it may not be distinguishable from other parts of body 110. Membrane 112b may be disposed on the inner surface adjacent to the patient (as shown in the figure) or at any other location.

[0041] In one example, the membrane 112b is integrally formed with the electronic device housing 112a of the housing portion 112, for example, by forming the housing portion 112 (i.e., both the electronic device housing 112a and the membrane 112b) with an elastomer (e.g., silicone resin) through a molding process, thereby housing the electronic device 120 therein. In this case, the housing portion 112 itself may form the membrane 112b. In another example, the membrane 112b is formed separately from the electronic device housing 112a, and the membrane 112b is attached to the electronic device housing 112a, for example, to a sheet or other component (e.g., a component formed of polytetrafluoroethylene) of the electronic device housing 112a (e.g., molded therein or attached thereto with an adhesive). In another example, the membrane 112b is formed on the electronic device housing 112a, for example, by coating and curing silicone resin on the electronic device housing 112a to form the membrane 112b and seal the chamber of the electronic device housing 112a.

[0042] In other examples, the power source 260 could be another type of battery or capacitor that does not require air during operation. In this case, membrane 112b is not required, although the electronic device housing 112a may still be formed of a breathable material (e.g., silicone).

[0043] Instead of being configured to allow airflow to the power supply 260, the housing portion 112 may also provide physical access to the electronics 120 (e.g., the power supply 260) and / or the communication interface 280. See also... Figure 1D In this case, the housing portion 112 may include a removable portion 112c, which opens the opening 112d when the removable portion 112c is removed. Figure 1D (Not shown separately), the opening 112d provides physical access to the electronics 120 (particularly to the power supply 260) and / or the communication interface 280. Physical access to the power supply 260 allows for replacement (e.g., if the power supply 260 is a primary battery) or recharging (e.g., if the power supply 260 is a secondary battery). Physical access to the communication interface 280 allows for connection to the communication interface 280 using physical (e.g., conductive) connections, such as using a dedicated or standardized interface.

[0044] The removable portion 112c can be constructed in various different ways. In one example, the wearable electronic device 100 is a reusable device, while the removable portion 112c is disposable, so that the removable portion 112c cannot reseal the opening 112d of the housing portion 112. In one example, the removable portion 112c may be formed of silicone resin that is formed together with or coated and cured onto the electronic device housing 112a. The removable portion 112c is removed by permanent deformation, for example by tearing the removable portion 112c off the housing portion 112. Because the removable portion 112c requires permanent deformation to remove, the wearable electronic device 100 can be considered a single-use device. The removable portion 112c and the housing portion 112 can be configured to cooperate with each other to allow the removable portion 112c to be removed without damaging the housing portion 112. For example, the removable portion 112c may be formed of a weaker and / or thinner material, and / or an intermediate member (e.g., a more rigid material component defining the opening 112d) may be arranged between the removable portion 112c and the housing portion 112. In another example, the removable portion 112c may be a separate component attached to the housing portion 112 (e.g., a removable cover), for example by an adhesive (e.g., a glue) or a cap (e.g., mechanically attached to the housing portion 112, for example by a press fit, threaded connection, and / or clamping). The removable portion 112c may form a membrane 112b.

[0045] Instead of being configured to allow airflow to power source 260 and / or provide physical access to electronics 120, housing portion 112 may be configured to allow removal of electronics 120 from body 110. For example, wearable electronics 100 may be configured as a single-use device worn by a patient for a limited time. Body 110 may be a disposable component, while electronics 120 is configured as a reusable module that can subsequently be incorporated into another wearable electronics 100 having a new body 110. Body 110 may be formed, for example, by molding a polymer compound (e.g., an elastomer, such as silicone) or a plastic (e.g., ABS) to form housing portion 112 surrounding electronics 120. Body 110 is configured to allow removal of electronics 120 if permanent deformation (e.g., irreversible damage) of housing portion 112 of body 110 is required, for example by cutting and / or tearing off the material forming housing portion 112 of body 110. The body 110 and the electronics 120 may be configured to facilitate the removal of the electronics 120 from the body 110 of a different wearable electronic device 100 in a repeatable manner and / or without damaging the removed electronics 120. For example, the housing portion 112 may be formed of a material that is weaker and / or thinner than the surrounding material, or the housing portion 112 may include separate weakened regions (e.g., thinned regions). Alternatively or additionally, the electronics 120 may include mechanical features that facilitate cutting and / or tearing off the housing portion 112, such as sharp edges (e.g., formed by its circuit board).

[0046] The body 110 may also include a machine- and / or human-readable tag 116. For example, the tag 116 may include a unique identifier, such as a serial number having human-readable alphanumeric characters and / or a machine-readable barcode. The human-readable identifier may allow a prescriber to associate a specific wearable electronic device 100 of the wearable electronic devices 100 with a specific patient (e.g., in a medical health record). This human-readable identifier may be printed on or formed in the material forming the body 110, or it may be printed on or formed on a printed label affixed to the body 110. The machine-readable identifier allows a system (e.g., at a processing facility) to identify a specific wearable electronic device 100 of the wearable electronic devices 100 for processing operations. The tag 116 may also include a machine-readable orientation indicator that allows a system (e.g., at a processing facility) to locate and orient the wearable electronic device 100 for subsequent processing (e.g., data transfer, restoration, disassembly, and / or recycling).

[0047] Any suitable combination of the various features of the aforementioned body 110 can be made. In a first preferred example, the body 110 includes a single integral polymeric component forming a housing portion 112, wherein the electronic device 120 is completely sealed by the housing portion 112 (e.g., molded therein). The connecting portion 114 may also be integrally formed with the housing portion 112. In a first preferred example, the body 110 may be configured as a single-use component, configured such that the body 110 needs to be permanently deformed to access the communication interface 280 or otherwise access or remove the electronic device 120. In a first preferred example, the polymer of the housing portion 112 may form a film 112b. The polymer compound may be an elastomer, such as silicone, or a plastic (e.g., ABS plastic).

[0048] In a second preferred embodiment, the body 110 includes a polymer component forming a single integral portion of the housing portion 112, and a membrane 112b formed separately from and coupled to the housing portion 112 to seal the electronic device 120 (e.g., molded therein) within the housing portion 112. The coupling portion 114 may also be integrally formed with the housing portion 112. In the second preferred embodiment, the body 110 may be configured as a single-use component, designed to require permanent deformation of the body 110 to access the communication interface 280 or otherwise access or remove the electronic device 120. The polymer may be an elastomer, such as silicone, or a plastic (e.g., ABS plastic).

[0049] In a third preferred example, the body 110 includes a single, integral polymer component forming an electronics housing 112a and a connecting portion 114 of a housing portion 112, wherein the electronics housing 112a includes an opening 112d sealed by a removable portion 112c to seal the electronics 120 within the housing portion 112. In the third preferred example, the body 110 may be a reusable component (e.g., for use by different patients). The removable portion 112c may be formed in any of the above-described manner. The polymer may be an elastomer, such as silicone, or a plastic (e.g., ABS plastic).

[0050] refer to Figure 1EWearable electronic device 100A is a variant of wearable electronic device 100 and typically includes a housing portion 112 and a connecting portion 114 that are separately formed and connected to each other. As shown, housing portion 112 may be configured as a housing (e.g., a container) containing electronic device 120, while connecting portion 114 is configured as a strap connected to housing portion 112. For example, housing portion 112 may be configured as a sealed can (e.g., a substantially cylindrical can) or a container with another suitable shape (e.g., a straight container or other box with an ultrasonically welded lid).

[0051] The connecting portion 114 is configured as a strap (e.g., a band) that can be sufficiently elastic to stretch beyond the user's hand, thereby holding the housing portion 112 very close to the user's wrist, or the strap can be non-stretchable (e.g., insufficient to stretch beyond the user's hand) but releasably coupled to the housing portion 112 for wearing around the user's wrist. The housing portion 112 may include a female component 113 (e.g., a hook) at its end, which receives and engages with the end of the connecting portion 114 (e.g., the end of the band). For example, the female component 113 may be smaller than the nominal size (e.g., diameter) of the connecting portion 114 to receive and press the connecting portion 114 therein, thereby holding the connecting portion therein. The housing portion 112 can be made from any suitable material according to any suitable manufacturing method, such as polyethylene terephthalate (PETG) or other polymers by injection molding, extrusion, and / or additive manufacturing. The housing portion 112 in which the electronic device 120 is housed can be sealed in any suitable manner, for example, by ultrasonic welding or by sealing a cover or cap (not shown) attached thereto in other ways.

[0052] refer to Figure 2A As described above, the electronic device 120 includes one or more motion sensing units 230, a controller 240, a data storage device 250, a power supply 260, and a communication interface 280, which can be coupled to the substrate 290 to form an electronic device module. In some embodiments, the electronic device 120 may also include a proximity sensor 270. As described above, the electronic device 120 is coupled to the body 110, for example, configured as a module encapsulated by the body 110 (e.g., sealed within a housing portion 112 of the body 110). Furthermore, as described below, the electronic device 120 or its module may be configured to conform to the patient when the wearable electronic device 100 is worn.

[0053] The motion sensing unit 230 is configured to sense the patient's movements, such as the movement of the wrist of a patient wearing the wearable electronic device 100, and output motion data based on the patient's movements. The motion sensing unit 230 can sense motion when the wearable electronic device 100 is operating in a motion data collection mode. As will be discussed in further detail below, the motion sensing unit 230 can begin sensing motion when the power is turned on 260 (e.g., when the metal-air battery is exposed to air), when ambient light is detected (e.g., via the light sensor 292, which will be discussed in further detail below), and / or when the wearable electronic device is detected to be worn (e.g., by detecting a patient via the proximity sensor 270).

[0054] The motion sensing unit 230 includes one or more sensors for sensing motion, which may be referred to as motion sensor 232. The term "motion" is considered to include acceleration and velocity, such as linear acceleration, linear velocity, rotational acceleration, and rotational velocity. Motion can be measured directly, for example, by a motion sensor that measures linear acceleration (i.e., an accelerometer) or rotational velocity (i.e., a gyroscope). Alternatively, motion can be calculated from other measurements, such as deriving linear velocity or cumulative displacement from measured linear acceleration, or deriving linear acceleration and / or linear velocity from measured position.

[0055] As discussed in further detail below, the motion sensing unit 230 can be configured to measure different types of motion (e.g., linear acceleration and / or rotational speed) and environmental conditions that may affect motion measurements. However, for a compact, lightweight, and low-cost wearable electronic device 100, it may be particularly advantageous for the wearable electronic device 100 (i.e., the motion sensing unit 230) to perform only one or more types of motion measurements (e.g., linear acceleration along one or more axes) and not other types of motion measurements (e.g., rotational speed) or position measurements (e.g., local or global positioning) that can be calculated from the motion. As a result, by performing only one type of motion measurement, the number and cumulative size of the motion sensing unit 230 and its motion sensors can be reduced compared to performing additional types of motion or position measurements, and power consumption and associated power requirements can also be reduced.

[0056] The motion sensing unit 230 or its motion sensor can be configured to measure motion at any frequency suitable for assessing patient activity. For example, the motion sensor can measure motion more or less at frequencies between 1 Hz and 60 Hz, such as between 10 Hz and 30 Hz (e.g., 10 Hz). Furthermore, the motion sensing unit 230 can be configured to measure motion during the sensing period at regular sensing time intervals (e.g., periods), such as measuring motion over a period between 2 seconds and 30 seconds at sensing time intervals between 30 seconds and 10 minutes (e.g., measuring 10 seconds every 1 minute).

[0057] Furthermore, the motion sensing unit 230 or its motion sensor may be considered to include additional features or components suitable for outputting the measured motion in the form of motion data, such as power management, analog filters, analog-to-digital converters, digital filters, control logic, and / or input / output (I / O).

[0058] In a first preferred example, the motion sensing unit 230 includes one or more motion sensors that measure linear acceleration along one or more axes, which may be referred to as accelerometers. For example, the motion sensing unit 230 measures linear acceleration along three axes; for instance, the motion sensing unit 230 is or includes a triaxial accelerometer. Alternatively, the motion sensing unit 230 may measure acceleration along fewer than three axes, such as one or two axes. For example, the accelerometer may be a microelectromechanical system (MEMS) triaxial accelerometer, which may be configured as a single device (e.g., a chip) or multiple devices (e.g., separate chips that each measure acceleration along only one axis).

[0059] In a first preferred embodiment, the motion sensing unit 230 may further include one or more additional sensors for measuring one or more environmental conditions that affect the motion sensor measurements, and / or the one or more additional sensors may have other purposes. Such additional sensors may be referred to as environmental sensors. The environmental sensor of the motion sensing unit 230 may be or include a temperature sensor. In a specific example, the motion sensing unit 230 is or includes a combination of an accelerometer (e.g., a triaxial accelerometer) and a temperature sensor, which are configured cooperatively as a single device (e.g., a chip).

[0060] In a first preferred example, the wearable electronic device 100 and its motion sensing unit 230 measure only the linear acceleration of motion and are configured to not measure other motions, or the wearable electronic device 100 and its motion sensing unit 230 determine motion in a manner that does not measure linear acceleration. That is, the wearable electronic device 100 and the motion sensing unit 230 include motion sensors consisting only of accelerometers, excluding other types of motion sensors (e.g., gyroscopes) or position sensors (e.g., local or global positioning sensors) from which motion data can be derived.

[0061] In a second preferred example, in addition to measuring linear acceleration, the motion sensing unit 230 includes one or more motion sensors that measure rotational speed about one or more axes and may be referred to as gyroscopes. In a specific example, the motion sensing unit 230 measures rotational speed about three axes, for example, it is or includes a three-axis gyroscope. Alternatively, the motion sensing unit 230 may measure rotational speed about fewer than three axes (e.g., one or two axes). For example, the gyroscope may be a microelectromechanical system (MEMS) three-axis gyroscope, which may be configured as a single device with an accelerometer (e.g., an inertial measurement unit, such as a single chip), a single device without an accelerometer (e.g., another chip), or multiple devices (e.g., separate chips, each measuring rotational speed about only one axis).

[0062] In a second preferred example, the motion sensing unit 230 may include an environmental sensor, such as a temperature sensor as described above.

[0063] In a second preferred example, the wearable electronic device 100 and its motion sensing unit 230 measure linear acceleration and rotational speed, and are configured to determine motion without measuring other motions, or in any other way without measuring linear acceleration or rotational speed. That is, the wearable electronic device 100 and its motion sensing unit 230 include motion sensors consisting only of accelerometers and gyroscopes, excluding other types of motion sensors or position sensors (e.g., local or global positioning sensors) from which motion data can be derived.

[0064] In a further example, the wearable electronic device 100 and the motion sensing unit 230 may include an accelerometer, a gyroscope, and / or other sensors that directly measure motion or position from which motion can be derived.

[0065] refer to Figure 3The controller 240 is typically configured to control one or more operations of the electronics 120 of the wearable electronic device 100. For example, the controller 240 may activate the motion sensing unit 230 or collect motion data when the power is turned on 260, when a patient is detected by the proximity sensor 270, and / or when some other criterion is detected (e.g., the measured motion meets a threshold criterion, light exceeds a threshold criterion by a light sensor (e.g., an ambient light sensor, such as light sensor 292, which is discussed in further detail below), or based on a time criterion).

[0066] In a non-limiting example, controller 240 typically includes a processing unit 342, a memory 344, a storage device 346, a communication interface 348, and a bus 349 through which other components of controller 240 are communicatively connected to each other. Processing unit 342 can be any suitable processing unit that executes instructions, such as a central processing unit. Memory 344 is short-term volatile memory, such as random access memory (RAM). Storage device 346 is long-term non-volatile storage device, such as a solid-state storage medium. For example, storage device 346 can be a computer-readable medium including instructions that are executed by processing unit 342 to implement the devices, systems, and methods described herein. Communication interface 348 is configured to send and / or receive signals, for example, for operating various other electronic components and / or receiving information therefrom.

[0067] The controller 240 can be configured in any suitable form, including but not limited to a microcontroller, an application-specific integrated circuit (ASIC), a field-programmable gate array (FGPA), or as a separate component. The controller 240 can also be configured as an integrated unit together with the motion sensing unit 230, for example, configured as a system-on-a-chip (SoC) together with the motion sensing unit 230.

[0068] Data storage device 250 is configured to store motion data output from motion sensing unit 230 and its motion sensors. Data storage device 250 is a non-volatile long-term storage device, such as a solid-state storage device. Data storage device 250 stores motion data (e.g., accelerometer readings) in association with a time indicator, provided, for example, by a timer (e.g., a clock, timestamp counter) of controller 240. The time indicator may include a known date and time or may be another digital indicator that associates the date and time with the collected motion data. In some embodiments, for example, the motion data may be slightly processed to reduce the amount of stored motion data (e.g., by compressing, filtering, and / or averaging the data).

[0069] Exercise data can be stored in one or more secure and / or private ways. For example, exercise data can be stored in encrypted formats and / or other formats that require a security key to access the exercise data (e.g., when transferring exercise data from data storage device 250). Furthermore, exercise data can be stored anonymously; for example, the data storage device does not store patient identifiers (e.g., patient identification number or name), and / or the wearable electronic device 100 can be configured to not receive any patient identification information from the patient and / or prescriber (e.g., configured to not transmit data through devices associated with the patient and / or prescriber). Instead, the wearable electronic device may include device identifiers (e.g., serial numbers) associated with the patient identifier stored by the prescriber and / or distributor, such that only the prescriber and / or distributor can associate the exercise data or its assessment with the patient.

[0070] Data storage device 250 can have any suitable capacity to record time indicators and motion data, as described in further detail below, taking into account different operating modes and different stages of the wearable electronic device 100's lifespan. For example, the capacity of data storage device 250 can be more or less between 1MB and 4GB, such as between 400MB and 4GB. In an illustrative, non-limiting example, if motion data from three accelerometers (e.g., from a triaxial accelerometer) is stored in 16-bit format at a frequency of 30Hz over a minimum four-week wear period, the motion data would require approximately 400MB of data storage device 250. In another illustrative, non-limiting example, if motion data from three accelerometers is stored in 8-bit format at a frequency of 1Hz over a 14-day period, the motion data would require approximately 4MB of data storage device 250.

[0071] The data storage device 250 may be the storage device 346 of the controller 240, a separate component, or configured as an integrated unit together with the motion sensing unit 230, for example, configured as a system on chip (SOC) together with the motion sensing unit 230.

[0072] Power source 260 is configured to provide power for operating the electronics 120 of the wearable electronic device 100. In one example, power source 260 is a primary battery (i.e., a non-rechargeable battery), such as a metal-air battery (e.g., a zinc-air, lithium-air, aluminum-air, or magnesium-air battery) or other types of primary batteries (e.g., lithium, alkaline, or zinc-carbon batteries). Compared to secondary batteries (i.e., rechargeable batteries), primary batteries have the advantages of lower cost and / or higher power density, thus allowing for a smaller size while maintaining the same power capacity. Alternatively, power source 260 may be replaced by or include a secondary battery (i.e., a rechargeable battery), a battery with an exchangeable electrolyte (i.e., refillable), a capacitor, a supercapacitor, and / or an energy harvester.

[0073] The power source 260 can be configured in any suitable form. In one example, the power source 260 is a coin cell, which has the advantages of a relatively small form factor (e.g., low height), easy availability, and relatively low cost.

[0074] The power supply 260 has a suitable capacity to enable the wearable electronic device 100 to operate throughout its lifespan and in different operating modes.

[0075] In the case where the power source 260 is a metal-air battery, the body 110 and / or housing portion 112 and the power source 260 are configured to allow sufficient air to reach the metal-air battery to support its operation (e.g., through membrane 112b) or otherwise make its materials sufficiently permeable.

[0076] Furthermore, the wearable electronic device 100 can be configured such that the metal-air battery is not activated until an event associated with the patient wearing the wearable electronic device 100 occurs. For example, the wearable electronic device 100 can be housed in a package 402 that prevents air from reaching the metal-air battery (e.g., before it is opened). Figure 4A As shown in the diagram, or the wearable electronic device 100 may be provided with a removable airtight barrier 404 that prevents air from reaching the metal-air battery (e.g., as shown in the diagram) before it is removed. Figure 4B(as shown in the diagram). In each case, the packaging 402 or the removable, airtight barrier 404 may include printed instructions to advise against opening the packaging or removing the barrier before wearing the wearable device, and / or against wearing the device if the packaging has been opened or the barrier has been removed. The packaging 402 may also contain oxygen-absorbing material to protect the power supply 260 and / or absorbent material. Alternatively, as discussed below, the packaging 402 may be opaque when the wearable electronics 100 may include a light sensor 292. When the wearable electronics 100 is removed, the light sensor 292 receives light from the environment (e.g., ambient light) and activates the wearable electronics to detect the patient and / or their movement.

[0077] In other configurations, power supply 260 may operate before wearable electronics 100 is worn to detect a patient (e.g., via proximity sensor 270, as discussed below), or it may be activated upon the occurrence of a physical trigger associated with a patient wearing the device (e.g., activating proximity sensor 270 and / or motion detector 130 after the trigger). For example, power supply 260 may include a permanent switch that closes when the device is worn, for example, via an electrically insulating member that is removed from electrical contacts of power supply 260 and other electronics 120 to close the circuit between them when body 110 is stretched or bent around a patient's wrist. Such physical (e.g., mechanical) triggering may include cutting wires, connecting or disconnecting coupling portion 114 of body 110, magnetic switches, and / or removing clips, pins, or adhesives. As previously described, optical triggering (e.g., removing wearable electronics 100 from an opaque package) may be used instead of physical triggering to activate wearable electronics 100.

[0078] Wearable electronic device 100 and / or electronic device 120 may be configured to replace power source 260. For example, wearable electronic device 100 and / or electronic device 120 may have spring contacts that conductively and mechanically releasably engage power source 260. Alternatively, power source 260 may be configured to be reusable by replacing its electrolyte or by electrically connecting it to a power source (e.g., via a wired connection to conductive contacts or a wireless connection to a remote sensing coil) for regular recharging. As previously described, body 110 (e.g., housing portion 112) may include an opening 112d sealed by a removable portion 112c, but which provides physical access to power source 260 for replacement or recharging, or electronic device 120 may be completely removed from body 110 to provide physical access to power source 260. In some embodiments, wearable electronic device 100 and / or electronic device 120 are configured not to recharge power source 260 (e.g., excluding contacts or coils that can transfer power to power source 260).

[0079] In some embodiments, the wearable electronic device 100 may include a proximity sensor 270. The proximity sensor 270 may be used to determine whether the motion sensing unit 230 is activated to collect motion data (e.g., by determining whether the wearable electronic device 100 is being worn, or by determining its proxy indicative, such as battery capacity exceeding a threshold). For example, battery capacity data may be recorded for prescribers to assess patient compliance with prescriber instructions. As discussed in further detail below, the proximity sensor 270 may operate in a patient detection mode and also in a motion data collection mode.

[0080] The proximity sensor 270 can be any suitable type of sensor for detecting whether a patient is approaching. In one example, the proximity sensor 270 is a capacitive sensor. The proximity sensor 270 can be arranged on the underside of the substrate 290 such that the substrate 290 is not located between the patient and the proximity sensor 270 when the patient wears the wearable electronics 100. In a preferred example, a physical barrier is arranged between the proximity sensor 270 and the patient detected by it, which may include a portion of the body 110 (e.g., housing portion 112).

[0081] When the wearable electronic device is not worn by the patient, the proximity sensor 270 is configured to operate in a manner that consumes relatively little power. For example, the proximity sensor 270 can be configured to operate in short durations (e.g., between one-tenth of a second and ten seconds) spaced at large intervals (e.g., between 5 minutes and 4 hours, or, for example, between 10 minutes and 20 minutes), which may be referred to as the patient detection duration and the patient detection interval. The patient detection interval can be configured relative to the possible wearing period, such that motion data is collected for the majority of the period during which the patient wears the wearable electronic device 100 (e.g., no motion data may be collected for periods at most equal to the patient detection interval). For example, the prescriber may specify that the wearable electronic device 100 be worn for a week, with the patient detection interval being several hours. While collecting motion data, the proximity sensor 270 can be configured to continue operating at the patient detection interval to confirm that the patient is still wearing the wearable electronic device 100 and to allow the wearable electronic device 100 to continue operating to collect motion data. If the proximity sensor 270 does not detect the patient, the wearable electronic device 100 stops collecting motion data until the proximity sensor 270 detects the patient again (e.g., operating in patient detection mode instead of motion data collection mode).

[0082] The communication interface 280 of the wearable electronic device 100 allows data to be transferred between the wearable electronic device 100 and another computing device (e.g., a computing device of a processing facility, as discussed in further detail below). For example, the communication interface 280 enables motion data to be transmitted from the wearable electronic device 100 after the patient has worn it. The communication interface 280 also enables the wearable electronic device 100 to receive data, such as sending signals to initiate the transmission of motion data and / or to provide data to the wearable electronic device 100 (e.g., updated software programming, through which the controller 240 operates the wearable electronic device 100) (e.g., may include encryption keys).

[0083] The communication interface 280 can take any suitable form for transmitting data from the wearable electronic device 100. In a preferred example, the communication interface 280 provides wired data transmission by including conductive contacts configured to be electrically coupled to corresponding conductive contacts of a paired communication interface of another computing device, for example, directly from data storage device 250 (e.g., a bus connected to data storage device 250). In another example, the communication interface 280 is configured for wireless communication and includes appropriate hardware (e.g., coils, antennas, or semiconductors) for transmitting and / or receiving data according to any suitable protocol (e.g., Bluetooth), and such hardware may also serve to harvest energy (e.g., RF energy) to supplement power source 260 or another power source. In some embodiments, the wearable electronic device 100, the electronics 120, and its communication interface 280 are configured to transmit motion data without wireless means (e.g., excluding antennas or other devices capable of wirelessly transmitting data).

[0084] The communication interface 280 may be encapsulated by the body 110, regardless of whether it is configured for wired or wireless data transmission. For example, the body 110 may include a removable portion 112c that, when removed, opens an opening 112d to provide physical access to the communication interface 280. In another example, the body 110 is configured to allow the electronic device 120 to be removed from the body 110 (e.g., cut or torn). In each case, physical access to the communication interface 280 may require the body 110 to be permanently deformed and / or prevent patients and prescribers from accessing the communication interface 280.

[0085] Electronic device 120 can be configured as a single unit, for example, by being coupled to substrate 290, such as a circuit board, through which power and / or signals can be transmitted between different electronic components. Substrate 290 and electronic device 120 coupled thereto can be referred to as a cooperating electronic device module.

[0086] The substrate 290 and / or electronic module can be configured to conform to the patient in a radial direction relative to the patient (e.g., radially inward and outward relative to the patient's wrist) and / or in a tangential direction relative to the patient (e.g., along the patient's wrist surface). For radial conformation, in a preferred example, the substrate 290 is a flexible circuit board, which may also be referred to as a flex plate. In this case, the substrate 290 conforms radially by bending around the patient's wrist. Instead of or in addition to the substrate 290 being a flexible circuit board, a compressible material (not shown; e.g., a foam pad with better compressibility than the substrate 290 and / or the housing portion 112 formed around the substrate 290) is disposed between the patient and the substrate, and the substrate 290 may also be covered by the material forming the body 110. In another embodiment, the body 110 (e.g., its electronic device housing 112a) can function as a substrate 290, for example, in which various electronic components are embedded and supported, and in which conductive pathways are formed between the various electronic components (e.g., silver, graphene, graphite, copper, or graphene-impregnated silicone resin), for example, by additive manufacturing processes or other suitable manufacturing processes.

[0087] In some embodiments, the electronic device module can be physically separated from the material of the housing portion 112 forming the body 110, for example by arranging sheets between them, which allows for shearing motion between the electronic device module and the body 110 when the strip is stretched. Alternatively or additionally, various components of the electronic device 120 can be encapsulated (e.g., encapsulated in epoxy resin) to fill the gaps between these electronic components that would otherwise be filled by the material of the body 110 molded around it, and / or to form a smooth surface that allows the electronic device module to be more easily removed from the body 110.

[0088] refer to Figure 2BIn addition to the previously described motion sensing unit 230, controller 240, data storage device 250, power supply 260, and communication interface 280, electronic device 120 may also include a light sensor 292. For example, the light sensor 292 may be a photodiode or phototransistor that can change its output (e.g., current and / or voltage) based on the ambient light it receives. As discussed in further detail below, the light sensor 292 may be used as a trigger or to otherwise determine when to change the mode and / or operation of different sensors, such as initiating operation of the proximity sensor 270 (e.g., for detecting a patient), initiating operation of the motion sensing unit 230 (e.g., via the proximity sensor 270), initiating recording of a time indicator, initiating recording of motion data, stopping and / or restarting operation of the proximity sensor 270, stopping and / or restarting operation of the motion sensing unit 230, and / or stopping and / or restarting recording of motion data. As used herein, when the term "start" is used in conjunction with the operation of various sensors and / or different modes, "start" generally refers to the first time such an operation is performed after the wearable electronic device 100 has been manufactured and removed from its packaging 402 (e.g., after a patient wears the wearable electronic device 100). The term "restart" generally refers to such an operation occurring subsequently after it has ended.

[0089] In one example, controller 240 operates in a low-power state, and light sensor 292 outputs a signal to controller 240 (e.g., its processor 342) that acts as a trigger or interrupt to start controller 240 (e.g., its processor 342), and controller 240 begins to operate as a timer or clock (i.e., providing a time indicator), and controller 240 may also begin to activate proximity sensor 270 to detect a patient wearing wearable electronics 100 (e.g., if the battery capacity exceeds a threshold) and / or may also begin to activate motion sensing unit 230 to detect patient movement and / or detect the patient (e.g., based on the detected movement). For example, controller 240 may cause power source 260 to provide power to proximity sensor 270 and / or motion sensing unit 230 to enable them to operate. Therefore, after the light sensor detects ambient light or in response to the light sensor detecting ambient light, a timer starts providing a time indicator, and one or more motion sensing units in the motion sensing unit begin sensing motion, proximity sensing begins to operate to sense the patient, and motion data (or other data derived from it) is stored in association with the time indicator. The motion data can also be processed to provide other data (e.g., processed motion data), such as root mean square processing of motion data along three axes (e.g., accelerations along three vertical axes).

[0090] The timer can continue to provide a time indicator until subsequent data transfer occurs between the data storage device and the computing device. For example, when the timer starts providing a time indicator after the light sensor detects ambient light, this time indicator is not associated with specific data and time. Therefore, allowing the timer to continue operating until subsequent data transfer allows the time indicator to be associated with a known date and time by transmitting a known date and time to store it in association with the time indicator on the wearable electronic device 100, or by transmitting motion data or other data derived from it to the computing device to store it in association with a known date and time.

[0091] The light sensor 292 and / or motion sensing unit 230 can also be used to determine when to stop and / or restart various operations. For example, after ambient light is not detected (e.g., above a threshold) and motion is not detected (e.g., above a threshold) and / or in response to the inability to detect ambient light and motion, such as when the wearable electronic device 100 is placed in a return package, the controller 240 may stop recording motion data and / or stop or otherwise slow down the operation of the motion sensing unit (e.g., by operating less frequently and / or at a lower frequency) to save power.

[0092] The light sensor 292 can also function as a signal receiver (e.g., in place of or in addition to the communication interface 280), for example, receiving instructions and / or programming from an external source (e.g., during manufacturing and / or when the wearable electronic device 100 is processed to extract motion data therefrom).

[0093] Electronic device 120 may also include a light source 294, which may be configured to provide the patient with a visual indication that the wearable electronic device 100 is functioning normally. For example, the light source 294 may be an intermittently operating light-emitting diode, for example, turning on once or multiple times at an indicator frequency (e.g., flashing or blinking), such as once per minute. Alternatively or additionally, the light source 294 may respond to shaking of the wearable electronic device 100 (e.g., measured by motion sensor unit 230 or motion sensor 232) by emitting light. In conjunction with housing portion 112, the light source 294 may be configured to not disturb the patient, for example, by emitting a low level of light. For example, the light source 294 may output light at 10 lumens, 8 lumens, 5 lumens, 2 lumens, or less.

[0094] The light source 294 can also function as a signal transmitter (e.g., replacing or replacing the communication interface 280), for example, transmitting motion data during processing. In this case, the light source 294 can be referred to as a signal transmitter, either directly or indirectly. When transmitting signals, such as motion data signals, the light source 294 may consume relatively more power compared to when it functions as an indicator and receives power from an external power source. The light sensor 292 and the light source 294 can cooperate to function as and replace the communication interface 280.

[0095] It should be noted that housing portion 112 or its sub-portions may also be configured to allow light to pass through them (e.g., be translucent or transparent), allowing ambient light to reach light sensor 292, for example, to activate wearable electronic device 100 and / or to allow light from light source 294 to pass through them to reach the environment. As mentioned, wearable electronic device 100 may be provided to a patient in an opaque package (e.g., a system having an opaque package and the wearable electronic device being housed within it), such that removing wearable electronic device 100 causes light to reach light sensor 292, activating wearable electronic device 100 (e.g., changing its operating mode to begin detecting the patient and / or movement). For example, the opaque package (e.g., package 402) may be made of polyester film or other opaque polymer, which may be metallized and also acts as a Faraday cage, preventing proximity sensor 270 (e.g., capacitive sensor) from detecting objects outside the package. The package may contain wearable electronic device 100. Alternatively, an opaque cover may be attached to and removed from the housing portion 112, which prevents ambient light from reaching the light sensor 292.

[0096] refer to Figure 2C and Figure 2D Electronic device 120 can be disposed on substrate 290, which can be configured to be folded, rolled up and / or otherwise shaped to be accommodated within housing portion 112 (e.g., as shown in the image). Figure 1E and Figure 2D The flexible circuit board (e.g., flexible circuit) of the tube or can shown. The substrate 290 typically includes a central portion 290a and two peripheral portions 290b (e.g., wings) extending outward from the central portion 290a. The central portion 290a includes any suitable combination of a motion sensor 232, a controller 240, a data storage device 250, a power supply 260, a communication interface 280, a light sensor 292, and / or a light source 294 connected thereto. The two peripheral portions 290b form portions of a proximity sensor 270, for example, forming electrodes of a capacitive sensor.

[0097] The substrate 290 is contracted and housed within the housing portion 112, for example, by sealing it at the end of the housing portion 112. For example, the substrate 290 may be inserted into the housing portion, with the peripheral portion 290b located adjacent to the inner side of the housing portion 112, such that the peripheral portion 290b extends around a large portion of the inner circumferential surface of the housing portion 112, for example, at least 50%, 60%, 75%, 80%, or more of the inner circumferential surface. That is, the total width of the peripheral portion 290b, or, in the case where an electrode is formed by one peripheral portion 290b, the width of a single peripheral portion 290b, is greater than 50%, 60%, 75%, 80%, or more of the inner circumferential surface of the housing portion 112. A central portion 290a may be arranged between the two peripheral portions 290b. For example, the substrate 290 may be folded into the shape of the letter "W" or "Z" (e.g., having a W-shaped fold or a Z-shaped fold, respectively).

[0098] The substrate 290 may also include conductive contacts (e.g., positive and negative contacts) near the end of the housing portion 112, which are configured to receive power from an external source. For example, during handling of the wearable electronic device 100, a seal at the end of the housing portion 112 may be punctured, thereby mechanically deforming it to transmit motion data stored by the wearable electronic device 100 through corresponding conductive contacts that provide power to the electronics 120, for example, to the light source 294 and / or the communication interface 280.

[0099] Instead of preventing air from reaching the power source 260 (i.e., in the case where the power source 260 is a metal-air battery), the package 402 can be configured to provide further functionality, such as being configured to be resealable and include a return tag and / or include a marking 406 for easy handling. When configured as a Faraday can, the package 402 can be formed of a metallized material that prevents electromagnetic interference to the wearable electronic device 100 (e.g., its electronics 120, such as proximity sensor 270). The package 402 can also be configured to allow a patient to deliver the wearable electronic device 100 to a processing facility; for example, the package 402 is resealable (e.g., having an embedded adhesive layer) and / or includes a shipping tag (e.g., a prepaid shipping tag). In the case where the power source 260 is a metal-air battery, the package 402 can be configured to allow air to reach the power source 260 when the package 402 is resealable. Package 402 may also include a label 406, which may be affixed to a shipping label or otherwise provided to facilitate handling of the wearable electronic device 100. Label 406 may be machine-readable to orient package 402 for physical handling (e.g., opening and removing the wearable electronic device 100) and / or to identify the wearable electronic device 100 (e.g., including a unique identifier associated with the wearable electronic device 100, such as a serial number, shipping tracking number, and / or a barcode or other QR code associated with it).

[0100] As described above, the wearable electronic device 100 can be configured to avoid affecting the patient's behavior, present few and / or very low barriers to use, and be relatively inexpensive. To achieve these objectives, the wearable electronic device 100 may exclude various types of electronic components, restrict the operation of such components, or prevent or otherwise limit interaction with such components (if included). Such excluded or restricted electronic components may be output components, input components, and / or electronic interface components.

[0101] The wearable electronic device 100 may not include an output device or may limit its operation; otherwise, the output device would provide an output that the patient can directly perceive from the wearable electronic device 100, which may draw the patient's attention to the wearable electronic device 100 and thus affect the patient's behavior.

[0102] Output devices can generally be categorized as visual output devices, audio output devices, or tactile output devices, each of which is an output device that can be selectively activated to provide an output. For example, wearable electronic device 100 may not include a display screen, may not include a light, may include neither a display screen nor a light, or may not include any visual output device; otherwise, the visual output device will be selectively activated to provide an output that the patient can perceive visually. Alternatively or in addition to omitting a visual output device, wearable electronic device 100 may not include a speaker, may not include a buzzer, may not include neither a speaker nor a buzzer, or may not include any audio output device; otherwise, the audio output device will be selectively activated to provide an output that the patient can perceive audibly. Alternatively or in addition to omitting visual and / or audio output devices, wearable electronic device 100 may not include any tactile output device; otherwise, the tactile output device will be selectively activated to provide an output that the patient can perceive tactilely.

[0103] In one embodiment, wearable electronic device 100 may include a simplified visual output device (e.g., a light source 294) but not other visual output devices. The simplified visual output device includes three or fewer lights (e.g., one LED light) that flash to provide one or more binary indicators (e.g., whether motion data is being collected, whether power supply 250 has reached a low power threshold, and / or whether data storage device 260 has reached a data storage threshold).

[0104] In other embodiments, the wearable electronic device 100 may include one or more of a visual output device, an audio output device, or a tactile output device, and may be configured to output limited information or to operate selectively in limited circumstances. For example, the wearable electronic device 100 may be configured to not output any indication of patient activity (e.g., an indication that motion data collection has started, is being collected, and / or has stopped, or the state of power supply 260). In another example, the wearable electronic device 100 may be configured to provide a limited type of output, such as being associated only with one or more of the following: power supply or operation of the wearable electronic device 100 (e.g., confirmation that the device is powered on), recording of motion data (e.g., at its start, during, and / or completion), power supply (e.g., an indicator of remaining power), transmission of motion data (e.g., at its start, during, and upon completion), or time (e.g., moment and / or time of data).

[0105] By excluding any direct output devices, excluding certain types of direct output devices, not providing activity-related outputs, or only providing outputs related to a limited range of types, wearable electronic devices can limit the circumstances that might otherwise affect a patient's behavior in order to attract their attention. Furthermore, by excluding various or any direct output devices, the weight, size, and cost of the wearable electronic device 100 can be reduced compared to including such direct output devices.

[0106] Wearable electronic device 100 may not include various direct input devices or may restrict its operation, as these direct input devices would otherwise allow or require conscious user input from the patient. Otherwise, requiring or allowing such input from the patient may draw the patient's attention or invite the patient to interact, thereby influencing the patient's behavior. Furthermore, requiring input from the patient or prescriber may increase real or perceived barriers to using wearable electronic device 100.

[0107] Input devices can generally be categorized as optical input devices, audio input devices, or physical input devices, each of which is configured to receive conscious input directly from a human. Conscious input is distinct from passive behavior that is intentionally observed (e.g., patient movement). For example, wearable electronic device 100 may not include any optical input device, which would otherwise be configured to receive optical input (e.g., gestures) from a patient or prescriber. Instead of or in addition to omitting optical input devices, wearable electronic device 100 may not include audio input devices (e.g., microphones), which would otherwise be configured to receive audio input (e.g., voice commands) from a patient or prescriber. Instead of or in addition to omitting optical or auditory input devices, wearable electronic device 100 may not include any physical input devices, which would otherwise be configured to receive conscious physical input that is physically detected (e.g., pressing a button, or swiping or other gestures). It should be noted that, in the context of the use of the detection described herein to indicate the amount of capacitance being worn by a patient, the proximity sensor 270 is not considered a physical input device, as the sensed capacitance is associated with the passive behavior of the patient wearing the wearable electronic device 100, rather than conscious user input.

[0108] In other embodiments, the wearable electronic device 100 may include one or more of an optical input device, an audio input device, or a physical input device, which are configured to not receive conscious input from the patient.

[0109] By excluding any direct input devices, or by receiving only direct input relevant to limited situations requiring or inviting patient interaction, the wearable electronic device 100 can limit situations that would otherwise affect patient behavior or present a barrier to use for the patient or prescriber. Furthermore, by excluding various or any direct input devices, the weight, size, and cost of the wearable electronic device 100 can be reduced compared to including such output devices.

[0110] Wearable electronic device 100 may not require electronic interaction between the patient or prescribing user and the wearable electronic device 100 (e.g., transmitting power and / or data, or any other electronic input or output), such as via power source 260 (e.g., charging or replacing a battery) and / or communication interface 280 (e.g., operating the wearable electronic device 100, retrieving, processing, or viewing motion data, or providing other conscious input to the wearable electronic device 100). Furthermore, wearable electronic device 100 may be configured to prevent the patient or prescribing user from electronically interacting with it via another electronic device.

[0111] As will be described in further detail below, power source 260 is configured to provide sufficient capacity to the wearable electronic device 100 to supply power throughout the lifespan of the wearable electronic device 100. Therefore, no patient, prescriber, or other custodian (e.g., the distributor of the wearable electronic device 100) is required to maintain or replace power source 260. Furthermore, as previously mentioned, physical access to power source 260 may be hindered by the need to damage the main body 110 or remove disposable parts to gain physical access to it. Therefore, maintaining power source 260 does not present any obstacle to use for the patient, prescriber, or other custodian.

[0112] Regarding communication interface 280, the wearable electronic device can be configured to prevent or eliminate the need for electronic interaction with communication interface 280, or to provide limited electronic interaction with communication interface 280. In one example, the wearable electronic device prevents or substantially impedes data transmission with communication interface 280 physically (e.g., by preventing physical access to power source 260 or by using a dedicated data connector, as described above) or electronically (e.g., by requiring access passwords or encryption keys to transmit and / or read motion data). Furthermore, interaction with communication interface 290 to initiate motion data collection may not be required (e.g., instead of collecting motion data when other triggers inherent to the use of wearable electronic device 100 are activated, such as when powered by a metal-air battery, detected by proximity sensor 270, or when the use of wearable electronic device 100 is triggered) or the wearable electronic device 100 may be otherwise configured for use (e.g., the patient, prescriber, or custodian does not provide data, such as patient or prescriber identification information, to wearable electronic device 100).

[0113] In another example, wearable electronic device 100 is configured to send and / or receive signals and data from another electronic device (e.g., wirelessly sent and / or received via communication interface 280). For example, wearable electronic device 100 may be configured to output motion data to an electronic device associated with the patient and / or may be configured to receive input from the user (e.g., subjective input of pain experienced by the patient) via other electronic devices, such as a smartphone or docking station (e.g., the smartphone or docking station may also charge power supply 260).

[0114] As described above, the wearable electronic device 100, (particularly) the electronic device 120, and their operation can be constructed according to their lifespan, which can be considered to generally include the wear period, the pre-wear period, and the post-wear period. The wear period is the period during which a patient wears or should wear (e.g., is prescribed to wear) the wearable electronic device 100. The pre-wear period is the period before the patient first wears the wearable electronic device 100. The post-wear period is the period after the patient has completed wearing the wearable electronic device 100. Various aspects of the wearable electronic device 100 can be constructed according to the pre-wear period, the wear period, and the post-wear period (e.g., ensuring that the wearable electronic device can operate during these periods). That is, the pre-wear period, the wear period, and the post-wear period are the basis for design. The wearable electronic device 100 can operate in various different modes, which generally correspond to the characteristics of different wear periods, but the wearable electronic device does not necessarily need to explicitly determine whether it will be worn during these periods.

[0115] The wear period is the time during which a patient wears the wearable electronic device 100 and enables the electronics to collect motion data. Collecting motion data is considered to include sensing motion via the motion sensing unit 230 and storing motion data via the data storage device 250. The wear period can be specified by the prescriber or determined in other ways (e.g., by the patient's actual wearing). For example, the wear period can be three days, one week, one month, or three months. For instance, the prescriber may provide the patient with four wearable electronic devices 100s specified for wear over a consecutive week.

[0116] The prescriber may specify the wear period within the minimum wear period of the wearable electronic device 100. The wearable electronic device 100 may be constructed based on the minimum wear period, which is a predetermined minimum amount of time during which the wearable electronic device 100 is configured to collect motion data. For example, the minimum wear period may be between one week and four months, such as approximately one week, two weeks, four weeks, or approximately eight weeks, or other suitable periods that take into account the anticipated differences in the wear period desired by the prescriber.

[0117] The minimum wear period is a design value, which may be exceeded during use. However, this minimum wear period is limited by the capacity of the power supply 260 or the data storage device 250, as well as the operation of other electronic components 120 and other factors. These other factors include, in particular, the operation of various sensors, the rate of motion data collection (e.g., frequency, number of sensors, and storage format), programming operations (e.g., stopping motion data collection after a predetermined period or when the battery is low), and environmental characteristics (e.g., temperature). The capacity of the power supply 260 and the capacity of the data storage device 250 will be discussed in further detail below with respect to the first and second embodiments of the electronic components 120 of the wearable electronic device 100.

[0118] The pre-wearing period is the period before the patient begins wearing the wearable electronic device 100 and typically after the wearable electronic device 100 has been manufactured. During the pre-wearing period, the wearable electronic device 100 can fill the data storage device 250 and consume power at a relatively low rate compared to the wearing period. For example, the wearable electronic device 100 can be configured to disable the motion sensing unit 230 and / or prevent it from collecting motion data during the pre-wearing period, for example by not turning on the power 260 (e.g., enabling the proximity sensor 270 and / or motion sensor 232 to be disabled) or by requiring the patient to be detected by the proximity sensor 270 in the first place.

[0119] The wearable electronic device 100 can be constructed based on a minimum pre-wear period, which is a predetermined minimum amount of time (e.g., shelf life) after which the wearable electronic device 100 is constructed to collect motion data for at least the minimum wear period. For example, the minimum pre-wear period can be more or less between one and three years. The wearable electronic device 100 may be provided with an indicator of the minimum pre-wear period, for example, in packaging that includes a printed expiration date or shelf life.

[0120] The post-wear period is the period after the patient puts on the wearable electronic device 100 and typically before and / or until the wearable electronic device 100 is remanufactured. In some implementations, depending on the configuration of the wearable electronic device 100, the collection of motion data and power consumption may be reduced during or part of the post-wear period compared to the wear period.

[0121] Wearable electronic device 100 can be constructed based on a minimum post-wear period, which is a predetermined minimum amount of time sufficient to sustain various operations. The minimum post-wear period typically takes into account the time between the user-worn device and subsequent processing equipment, and may include transportation time to the processing facility (e.g., for transport), delays between the user-worn device and the transport equipment, and any delays or times in subsequent processing. For example, the minimum post-wear period can range from one week to two months, such as more or less than one month.

[0122] Further reference Figure 5 The wearable electronic device 100 can be configured to implement a method 500 for collecting motion data from a patient. The wearable electronic device 100 is configured to collect motion data when the power supply 260 is operational or when one, the other, or both patients are detected by the proximity sensor 270.

[0123] Before any patient wears the wearable electronic device 100, the wearable electronic device 100 operates in one or both of a power-off mode or a patient detection mode, which typically corresponds to the pre-wearing period. In the power-off mode (also referred to as a power-off state), the power supply 260 is not activated, causing various other components of the electronics 120 to cease operation. The timer is not activated in the power-off mode. The power supply 260 may initially operate in various ways as described above, including exposing the metal-air battery to air (e.g., when removing the wearable electronic device 100 from an airtight package or removing an airtight cover from the wearable electronic device 100), when light is detected by the light sensor 292, or when a physical event associated with the patient's first wearing of the wearable electronic device 100 occurs (e.g., closing a permanent or repeatable switch accompanying the movement of the wearable electronic device 100).

[0124] In patient detection mode, a timer (e.g., a time step counter) operates, and proximity sensor 270 operates at patient detection intervals to assess whether wearable electronics 100 is being worn by a patient. In patient detection mode, motion sensing unit 230 may not operate and may not collect motion data, or alternatively, motion sensing unit 230 may operate at spaced intervals (e.g., patient detection intervals) and / or may record motion data as an alternative or auxiliary indicator of whether the wearable electronics 100 is being worn by a patient. In some embodiments, proximity data may be stored in association with a time indicator. If no patient is detected, proximity sensor 270 continues to operate at patient detection intervals to assess whether wearable electronics 100 is being worn by a patient. If a patient is detected (e.g., as determined by proximity sensor 270), wearable electronics 100 begins operating in motion data collection mode. It should be noted that before activating the proximity sensor 270 and switching the wearable electronics 100 to operate in motion data collection mode, the wearable electronics 100 may be worn by the patient for a period of time, which may be as long as the patient detection interval. The wearable electronics 100 may be packaged and / or otherwise constructed to prevent unintentional detection of the patient, for example, through packaging that can physically prevent false positives and / or having a higher sensing threshold that can detect the patient more definitively.

[0125] As described above, the wearable electronic device 100 can be configured to initially operate in one, the other, or both of a power-off mode or a patient detection mode. If configured to initially operate in a power-off mode instead of a patient detection mode, for example, if the wearable electronic device 100 does not include a proximity sensor 270, then when power 260 is activated, the wearable electronic device 100 begins operating in a motion data collection mode. In this case, the timer is not associated with a known date and time. Initially operating in a power-off mode (e.g., setting to a power-off state) allows for an extended pre-wearing period (e.g., shelf life) before the wearable electronic device 100 is used, but it may be necessary to continue operating the timer during the post-wearing period to subsequently associate motion data with a known date and time.

[0126] If configured to operate in a patient detection mode instead of initially operating in a power-off mode, the wearable electronic device 100 initially operates in a patient detection mode (e.g., typically during the manufacture of the wearable electronic device 100) and subsequently operates in a motion data collection mode when a patient is detected. In this case, a timer is associated with a known date and time, which allows motion data to be stored initially associated with a known date and time, and also allows the wearable electronic device 100 to be in a power-off mode during the period after being worn.

[0127] If configured to initially operate in a power-off mode and a patient detection mode, the wearable electronic device 100 initially operates in a power-off mode, then in a patient detection mode when power 260 is activated, and then in a motion data collection mode when a patient is detected. In this case, the timer is not associated with a known date and time, which may require the timer to continue operating for a period after wearing in order to subsequently associate the motion data with a known date and time.

[0128] In motion data collection mode, a timer is activated, and motion data is collected in association with a time indicator (e.g., a counter value and / or a known date and time). The time when the patient is first detected by the near sensor 270 typically corresponds to the start of the wearing period. In motion data collection mode, motion is sensed at an appropriate sensing frequency (e.g., more or less between 0.01 Hz and 60 Hz, such as 0.1 to 30 Hz). Motion data is output from the motion sensor 232 for storage by the data storage device 250.

[0129] If not configured to operate in patient detection mode, the wearable electronic device 100 operates in motion data collection mode until motion data is transmitted from it. Because the time indicator does not include known date and time information, the time indicator is recorded until motion data is transmitted and the known date and time can be associated with the last recorded time indicator, allowing for reverse calculation of the time indicator and previously recorded motion data using the known date and time. Therefore, motion data collection continues regardless of whether the patient is wearing the wearable electronic device 100.

[0130] As an alternative to operating in motion data collection mode until motion data is transmitted, the wearable electronic device 100 may operate in motion data collection mode until an operating threshold is reached, such as a time threshold (e.g., a predetermined duration for collecting motion data, such as during minimum wear), a data threshold (e.g., the cumulative amount of collected motion data or the remaining amount of data storage capacity, which may include reaching the total capacity of the data storage device), or a power threshold (e.g., remaining battery life, which may include exhausting all available power from power source 260).

[0131] After reaching the operating threshold, the wearable electronic device 100 operates in a low-power mode, in which the timer continues to operate while the motion sensing unit 230 is inactive and does not collect motion data. The operating threshold typically corresponds to the minimum wear period, and the subsequent period typically corresponds to the post-wear period. However, it should be understood that by not sensing whether the wearable electronic device 100 is worn, the wearable electronic device 100 operates in a motion data collection mode and a low-power mode regardless of whether it is worn.

[0132] If configured to operate in patient detection mode, the wearable electronic device 100 can be configured to return to patient detection mode when the proximity sensor 270 does not detect a patient or the motion sensor 232 does not detect motion. In one example, when in motion data collection mode, the proximity sensor 270 can continue to operate at patient detection intervals, and if a patient is detected again, the wearable electronic device 100 continues to operate in motion data collection mode, or if no patient is detected, the wearable electronic device 100 returns to patient detection mode. In another example, if the proximity sensor 270 is not operating in motion data collection mode, the wearable electronic device 100 can return to patient detection mode based on motion sensed by the motion sensing unit 230. For example, if very little motion is detected or no motion is detected within a predetermined amount of time (e.g., patient detection interval), the wearable electronic device 100 returns to patient detection mode, in which the proximity sensor 270 is again operated at patient detection intervals.

[0133] As an alternative to returning to patient detection mode, wearable electronic device 100 can be configured to operate in a motion data collection mode until motion data is transmitted therefrom (e.g., as described above), or until either the transmission of motion data therefrom or an operating threshold is reached, at which point wearable electronic device 100 operates in a low-power mode (as described above), in which proximity sensor 270 may also be inactive. In these configurations of wearable electronic device 100 where a timer is associated with a known date and time, the operating threshold may be residual power (e.g., turning off wearable electronic device 100).

[0134] The power supply 260 and data storage device 250 are configured to have sufficient capacity to operate in a power-off mode, a patient detection mode, a motion data collection mode, and a low-power mode. The wearable electronic device 100 is configured to operate in these modes. The capacity of the power supply 260 takes into account the operation of the power-off mode and any subsequent self-discharge and / or patient detection mode (e.g., sufficient power during the period before minimum wear), the power draw of the motion data collection mode and subsequent electronic devices (e.g., sufficient power to operate the motion sensing unit 230 and controller 240, and proximity sensor 270 (if so configured) during the period of minimum wear), and the power draw of the low-power mode and subsequent electronic devices 120 (e.g., sufficient power for reduced operation, such as operating a timer, during the period after minimum wear). The capacity of the data storage device 270 takes into account the patient detection pattern and the subsequent data storage (e.g., sufficient storage capacity for time indicators during the period before minimum wear), as well as the motion data collection pattern and the subsequent data storage (e.g., sufficient storage capacity for time indicators and motion data during the period of minimum wear).

[0135] Still referencing Figure 5 A method 500 for operating a wearable electronic device (e.g., wearable electronic device 100) is provided. Method 500 typically includes: initiating power delivery 510; activating a timer 520; sensing a patient 530; collecting motion data of the patient 540; evaluating an operating threshold 550; and reducing power consumption 560. In some embodiments of method 500, the sensing of the patient 530 may be omitted, the sensing of the patient 530 may be repeated after the collection of motion data 540, the evaluation of the operating threshold 550 may be omitted, and / or the reduction of power consumption 560 may be omitted.

[0136] The startup power delivery 510 includes first supplying power from a power source (e.g., power source 260) to electronic devices, which include motion sensors (e.g., motion sensing unit 230) and controllers (e.g., controller 240), and may also include proximity sensors, such as proximity sensor 270.

[0137] The wearable electronic device 100 can be provided to the patient in a power-off mode, in which case the startup power delivery 510 can be performed by supplying air to the metal-air battery forming the power source 260 (e.g., when the patient opens the airtight packaging containing the wearable electronic device 100, or removes the airtight cover from the wearable electronic device 100), by switching the power source 260 to supply power to other components of the electronics 120 (e.g., starting from an action typically associated with the first wearing of the wearable electronic device 100), or by employing other physical, mechanical, and / or optically controlled methods as previously described (e.g., based on the light sensor 292). In the case of providing the wearable electronic device 100 in a patient detection mode, the startup power delivery 510 is performed during the manufacture of the wearable electronic device 100 (e.g., when providing or connecting a power source).

[0138] The activation of timer 520 is performed by a controller (e.g., controller 240 (e.g., the clock of controller 240)), for example, by initiating power delivery 510. If the wearable electronic device is provided to the patient in a power-off mode, the timer is not associated with a known date and time (e.g., it operates as a counter). If the wearable electronic device is provided to the patient in a patient-wearing mode, the timer is associated with a known date and time due to the manufacturing process. The timer continues to operate during subsequent operations (e.g., until motion data is transmitted from the wearable electronic device, or until the power supply is depleted or otherwise prevented from supplying power to the controller).

[0139] Sensing of a patient 530 is performed using a proximity sensor (e.g., proximity sensor 270 (e.g., a capacitance sensor)) and a controller. If no patient is detected (e.g., if the capacitance does not exceed a threshold), sensing of the patient 530 is repeated at spaced intervals (e.g., the patient detection interval described above).

[0140] The sensing patient 530 may also include sensing motion via a motion sensing unit (e.g., motion sensing unit 230). For example, the motion sensing unit may operate at spaced intervals (e.g., in combination with a proximity sensor), and motion data combined with proximity data may be used to determine whether the patient is wearing a wearable electronic device.

[0141] If no patient is detected, the patient sensing is repeated at intervals 530. If a patient is detected, the collection of the patient's motion data begins 540.

[0142] As operated by a controller, the collection of patient motion data 540 is performed via one or more motion sensors (e.g., motion sensors of motion sensing unit 230) and a data storage device (e.g., data storage device 250). The collection of motion data 540 typically includes sensing the patient's motion 540A via the motion sensors and storing the motion data 540B in the data storage device in association with a time indicator output by a timer. Sensing motion 540A and storing motion data 540B can be performed continuously (e.g., at intervals completely different from those at intervals) at a suitable sensing frequency (e.g., more or less between 0.01Hz and 60Hz, such as between 0.1Hz and 30Hz, such as 30Hz, or 10Hz), or at a frequency such as between 2 seconds and 30 seconds, such as 10 seconds, within a motion sensing period (e.g., between 30 seconds and 10 minutes, such as every minute) at motion sensing intervals (e.g., between 30 seconds and 10 minutes, such as every minute). Between collecting and storing motion data, the motion data can also be processed, for example, by calculating the root mean square of the acceleration measured on each of the three axes and then storing that root mean square.

[0143] In the case where method 500 includes the operation of sensing patient 530, motion data collection 540 can be performed simultaneously with sensing patient 530. In this case, when no patient is detected and / or when no motion is detected, motion data collection 540 can be stopped, and then sensing patient motion 530 can be repeated.

[0144] Where method 500 includes or excludes sensing the patient 530, method 500 may further include evaluating an operational threshold 550, which is performed by a controller at any suitable frequency. For example, the controller may compare operational parameters (e.g., elapsed time, stored data, remaining power) with an operational threshold, which may be a time threshold (e.g., the time for collecting motion data), a data storage threshold (e.g., accumulated stored data or remaining storage capacity), or a power threshold (e.g., remaining power). If the threshold is not met, the wearable electronic device continues collecting motion data 540. If the threshold is still not met, the wearable electronic device reduces power consumption 560.

[0145] Reducing power consumption 560 includes reducing the power consumption rate of electronic devices (e.g., electronic device 120), for example, through a controller. Reducing power consumption 560 may include stopping the power consumption of the motion sensor by causing the electronic devices to operate in a low-power mode (as described above) by ceasing the collection of motion data 540. The timer resumes operation after reducing power consumption 560.

[0146] Alternatively, motion data collection 540 can be performed until the power supply is exhausted or the motion data is transferred from the data storage device.

[0147] refer to Figure 6 and Figure 7 A patient activity assessment system 600 and method 700 are provided for distributing and processing multiple wearable electronic devices 100 (e.g., thousands of wearable electronic devices 100). The patient activity assessment system 600 and method 700 are configured to distribute the wearable electronic devices 100, including manufacturing (or remanufacturing) the wearable electronic devices 100 and providing them to a patient. Processing the wearable electronic devices 100 includes transmitting motion data, processing motion data, and providing motion data reports to a prescriber (e.g., a physician), and may also include manufacturing or remanufacturing additional wearable electronic devices 100 from those already processed (e.g., reusing electronics 120 and possibly reusing or recycling the body 110). In some embodiments of the patient activity assessment system 600 and method 700, each of the wearable electronic devices 100 is configured as a limited-use (e.g., disposable) device, which is worn by only one user for a limited period (e.g., up to a minimum wear period).

[0148] The patient activity assessment system 600 typically includes a wearable electronic device 100, a manufacturing system 610, a receiving system 620, and a data system 630. The patient activity assessment system 600 may be located at one or more processing facilities 640 where a patient delivers a worn wearable electronic device 100. Various functions of the manufacturing system 610, receiving system 620, and / or data system 630 may be performed manually and / or automatically. The manufacturing system 610 is configured to manufacture the wearable electronic device 100, which may include restoring the electronics 120 of a previously worn wearable electronic device 100 for use by another patient. The receiving system 620 is configured to receive and mechanically process the wearable electronic device 100, and may include, for example, automated or manually executed processing for physically preparing the wearable electronic device 100 to transmit motion data from the wearable electronic device 100 or to recreate another wearable electronic device 100 (e.g., removing the electronics 120 from the body 110, or physically accessing the electronics 120 by removing the removable portion 112c from the body 110). The data system 630 is configured to transmit motion data, process motion data, and output analyzed motion data.

[0149] As previously described, manufacturing system 610 is configured to manufacture wearable electronic device 100, which may include manufacturing wearable electronic device 100 with new components and / or restoring the electronics 120 of a previously worn wearable electronic device 100 for use by another patient. In the case of manufacturing with new components, manufacturing system 610 may be located at the same or different processing facility 640 as receiving system 620 and data system 630. In the case of restoring electronics 120, manufacturing system may be located at the same processing facility 640 as receiving system 620. Restoring the electronics 120 may include restoring the power source 260 (e.g., by replacing, recharging, or refilling the battery that forms the power source), restoring the data storage device 250 (e.g., by deleting previously stored motion data, mapping defects therein, writing encryption keys shared with the data system 630, and / or encoding new unique identifiers or serial numbers), and resealing the electronics 120 in the body 110 (e.g., by replacing the removable portion 112c in the existing body 110, or by molding the electronics 120 into a new body 110 (e.g., molding it into the housing portion 112 of the new body 110)). In the case where the power source 260 is a metal-air battery, the power source 260 is also sealed to prevent contact with air, for example, by sealing the wearable electronics 100 in an airtight package or by applying a removable airtight seal to the wearable electronics 100. The manufacturing system 610 may also individually package each of the wearable electronic devices 100 in a package 402, which may include printing a date related to the lifespan of the wearable electronic device 100 (e.g., an expiry date or validity period, or a manufacturing date and an expiry date or validity period), printing a unique identifier associated with a particular wearable electronic device 100, and / or providing return mail packaging, labels, or instructions (i.e., for the patient to subsequently deliver the wearable electronic device to the processing facility 640).

[0150] The restoration of electronic device 120 may also include various inspections and / or tests of the electronic device, such as testing of data storage device 250, testing and / or calibration of various sensors (e.g., motion sensor of motion sensing unit 230 and / or proximity sensor 270), and testing of power supply 260 (e.g., battery).

[0151] The manufacturing system 610 can also process the body 110, for example, for reuse (e.g., sterilization and / or cleaning) or recycling (e.g., grinding the material that forms the body 110).

[0152] After manufacturing, the wearable electronic device 100 is provided to patients by a distributor. A prescriber (e.g., a physician) may prescribe for the patient to wear one wearable electronic device 100 for a specified wearing period (e.g., less than a minimum wearing period, such as a specified week or other desired duration), or for the patient to wear multiple wearable electronic devices over several consecutive specified wearing periods (e.g., four consecutive weeks). As specified by the prescriber, the distributor provides one or more wearable electronic devices 100 to each patient. The distributor may be a prescriber (e.g., a physician or licensed physician), who may be referred to as a prescription distributor, or through another distributor (e.g., a pharmacy), who may be referred to as an over-the-counter distributor. The distributor may associate a device identifier (e.g., a serial number) with a patient identifier (e.g., the patient's name identification number) and a prescriber identifier (e.g., the physician or licensed physician's identification number, username, or given name). For example, a distributor can associate a wearable electronic device with a patient by recording a device identifier in the patient's record (e.g., a medical record), which allows the prescriber to subsequently associate motion data from the wearable electronic device 100 with the patient wearing the wearable electronic device 100. Alternatively, a distributor can associate a wearable electronic device with a prescriber by providing both a device identifier and a prescriber identifier to a data system 630, such as via a simple message (e.g., email) or a dedicated portal (e.g., a computer). This allows the data system 630 to provide motion data to the prescriber or to allow the prescriber to access the motion data or its assessment (e.g., an activity assessment).

[0153] The receiving system 620 is configured to receive and prepare the wearable electronic device 100 for data transmission and / or for data restoration. The receiving system 620 may include various automated and / or manually performed operations, including physically preparing the wearable electronic device 100 for subsequent physical connection to the data system 630 for data transmission. This may include removing the electronics 120 from the body 110, removing the removable portion 112c, or inserting a conductive probe through the body 110 into the communication interface 280, each of which can permanently deform the body 110. In the case of removing the electronics 120 from the body 110, the material of the body 110 can be recycled and used to form a new body 110.

[0154] For example, the receiving system 620 may include one or more optical readers for reading a unique identifier on the packaging 402 of the wearable electronic device 100 and / or reading an orientation mark on the packaging 402. The receiving system 620 may also include an orientation system and an opening system, the orientation system being configured to orient the packaging 402 according to the orientation mark to facilitate the opening system opening the packaging 402 and removing the wearable electronic device. The receiving system 620 may also include one or more additional optical readers and / or one or more orientation devices for reading the orientation mark on the wearable electronic device 100, and the orientation devices for orienting the wearable electronic device 100 to facilitate the data system 630 connecting to the wearable electronic device 100, and / or to facilitate the disconnection system removing the body 110 from the electronic device 120.

[0155] Data system 630 includes one or more computer systems, each configured to perform one or more of the following: transmitting motion data from a wearable electronic device, processing motion data, or outputting processed motion data (e.g., patient activity assessment) to a prescriber. In a simplified example, a single computing device 632 is described herein, and this single computing device 632 includes a communication interface 632a for transmitting data (e.g., from data storage device 250 and outputting to a prescriber) and performing data transmission, processing, and output functions. However, it should be understood that multiple different computers may be used to perform one or more of these functions (e.g., multiple computers each performing all three functions, or multiple computers each performing one or both of these functions).

[0156] The computing device 632 includes a communication interface 632a that connects to the communication interface 280 of the wearable electronic device 100 to transmit motion data from the wearable electronic device 100. The communication interface 632a of the computing device 632 can be physically (e.g., electrically) or wirelessly connected to the communication interface 280 of the wearable electronic device 100. As described above, the wearable electronic device 100 may store motion data in encrypted and / or compressed formats, or require a security key to transmit motion data, and the data system 630 is configured to provide or otherwise utilize the security key to transmit and / or decrypt motion data of the wearable electronic device.

[0157] Data system 630, together with computing device 632, processes motion data transmitted from wearable electronic device 100, including analyzing the motion data to generate a patient activity assessment for each patient. As described above, motion data may include measurements of motion sensed by motion sensors, but not further analysis performed by wearable electronic device 100. Motion data processing can be performed in any suitable manner to quantitatively describe the patient's activity over time, for example, using common activity metrics (e.g., steps) or uniquely determined activity metrics with suitable algorithms. If motion data is recorded in association with time indicators that do not include date and time, processing may include associating motion data with specific dates and times based on the association of one of the time indicators with known dates and times (i.e., the current date and time) during motion data processing. Motion data processing may also include identifying times when wearable electronic device 100 is worn by the patient and times when it is not worn (e.g., identifying motion patterns associated with patient wear by comparing them to motion patterns associated with processing or transporting the wearable electronic device).

[0158] The data system 630, equipped with computing device 632, can output the analyzed motion data to the prescriber in any suitable manner, such as via email with a static report or via an interface (e.g., a portal) that allows manipulation of the analyzed motion data. The assessed motion data can be output as a patient activity assessment, which may include a quantification of the patient's activity relative to time. Motion data can be output anonymously, for example, by associating it with an identifier (e.g., a serial number) of the wearable electronic device 100.

[0159] As described above, after transmitting motion data from the data storage device 250, the electronic device can be restored for reuse by another patient in the wearable electronic device 100, or incorporated into a new wearable electronic device 100 (e.g., by molding a new body 110 around the electronic device 120 to form a new wearable electronic device 100).

[0160] refer to Figure 7A method 700 for assessing the activity of multiple patients is provided. Method 700 typically includes: manufacturing a plurality of wearable electronic devices 710; distributing one or more of the plurality of wearable electronic devices to each of a plurality of patients 720; collecting motion data through the plurality of wearable electronic devices 730; receiving the plurality of wearable electronic devices from the patients 740; physically processing the wearable electronic devices 750; transmitting motion data from the wearable electronic devices 760; processing the motion data 770; and outputting the assessed motion data to a prescriber 780; and may further include 790: repeating operations 710 to 780 on additional plurality of wearable electronic devices for additional patients.

[0161] Manufacturing multiple wearable electronic devices (e.g., wearable electronic device 100) 710 is performed using a manufacturing system (e.g., manufacturing system 610). The manufacturing operation 710 can be repeated for additional wearable electronic devices by replicating the electronics 120 and / or body 110 of the wearable electronic devices in earlier multiple wearable electronic devices (e.g., from previously worn wearable electronic devices).

[0162] Distributing one or more electronic devices 720 to each of one or more patients includes providing the patient with a wearable electronic device specified by the prescriber. The prescriber may be a distributor (e.g., a prescription distributor) or another distributor (e.g., an over-the-counter distributor). The distributor associates the electronic device provided to the patient with the patient (e.g., via an identifier as previously described). The distributor may also associate the wearable electronic device with the prescriber, so the distribution operation 720 may also include providing the previously described data system 630 with information received from the prescriber.

[0163] The collection of motion data 730 is performed using a wearable electronic device. For example, depending on the configuration of the wearable electronic device, the collection of motion data 730 can be performed using the wearable electronic device according to method 500 or any other suitable method.

[0164] Receiving multiple wearable electronic devices 740 is performed via a receiving system (e.g., receiving system 620) of a processing facility (e.g., processing facility 640). The receiving operation 740 includes receiving wearable electronic devices 740 from a patient via a package or other means of transport for individual wearable electronic devices.

[0165] For example, physical processing 750 of the wearable electronic device may be performed via a receiving operation or via another processing system. Physical processing operation 750 includes processing the wearable electronic device to provide physical access to the electronics of the wearable electronic device for connecting to a communication interface of the wearable electronic device to transmit motion data therefrom and restoring its electronics for subsequent use by the wearable electronic device. Therefore, physical processing operation 750 includes either removing electronics from the strap of the wearable electronic device (e.g., the body 110, for example, from the housing portion 112 on the body 110) or removing a removable cover (e.g., a removable portion 112c) from the strap. Physical processing operation 750 may also include removing and / or discarding power, such as power supply 260, from the electronics. Physical processing operation 750 may include permanently deforming the strap or housing portion of the wearable electronic device to provide physical access to the electronics.

[0166] For wearable electronic devices that wirelessly transmit data and / or power, physical processing operations 750 can be omitted.

[0167] The transmission of motion data 760 includes a communication interface connected to the wearable electronic device via a computing system (e.g., data system 630), such as a communication interface of the computing device of data system 630 (e.g., communication interface 632a of computing device 632). Depending on the configuration of the wearable electronic device, a physical connection (e.g., via conductive contacts) or a wireless connection may be made. The transmission operation 760 may also include providing a security key to the wearable electronic device, which may be required to retrieve or otherwise access the motion data of each wearable electronic device.

[0168] Processing motion data 770 includes processing motion data to assess patient activity. For example, motion data may be processed over time to quantify activity (e.g., steps per hour or per day, or other suitable quantification of activity). Processing motion data 770 is performed by a data system and its computing devices, such as the computing device performing transmission operation 760 or another computing device receiving motion data from that computing device. Processing motion data may also include associating motion data with dates and times, for example, by retrospectively analyzing a time indicator (e.g., a counter) associated with the motion data based on a known (e.g., current) date and time. Processing motion data 770 may also include identifying motion data corresponding to the patient's movement while wearing the wearable electronic device by comparing it to other movements of the wearable electronic device (e.g., during transport). Processing operation 770 may also include decrypting motion data from each wearable electronic device. Processing operation 770 may include generating a patient activity assessment report that includes quantifications of patient activity.

[0169] Outputting assessed motion data 780 includes sending, otherwise outputting processed motion data (e.g., quantification of patient activity), or providing access to the processed motion data to the prescriber. The prescriber's information is received by the data system as part of the distribution wearable electronic device 720. Output operation 780 is performed by the data system, such as a computing device of the data system, which may be the same as or different from the computing device that performs the transmission of motion data 760 and the processing of motion data 770. Output operation 780 may be anonymized for the patient; for example, neither the data system nor the wearable electronic device receives the patient's identification information. Instead, the prescriber may associate the assessed motion data with the patient. Alternatively, output operation 780 may include providing the assessed motion data associated with a patient identifier.

[0170] Repeated operation 790 includes repeating operations 710 to 780 on subsequent multiple wearable electronic devices (e.g., a second, third, fourth, and more). In some embodiments, manufacturing operation 710 may include restoring the electronics of the wearable electronic device prepared during the physical processing operation 750 of the wearable electronic device in the earlier multiple wearable electronic devices, which may include restoring the power supply (e.g., replacing the battery) and restoring the data storage device (e.g., by removing motion data from a previous patient). Repeated manufacturing operation 710 includes resealing the electronics, for example, by resealing it in an existing electronic device housing (e.g., by providing a new removable seal, such as by applying a new silicone or other seal) or by forming a new strip around the electronics (e.g., molding a new strip of silicone around the electronics to fit the electronics into the electronic device housing portion). In the case where the power source is a metal-air battery, manufacturing operation 710 also includes preventing air from reaching the battery, for example by sealing the wearable electronic device in an airtight package or attaching a removable airtight cover (e.g., adhesive).

[0171] In addition to and / or consistent with the foregoing description, the present invention covers the following embodiments:

[0172] 1. A wearable electronic device, comprising:

[0173] A motion sensing unit that senses motion and outputs motion data based on the sensed motion;

[0174] A data storage device that receives and stores motion data;

[0175] A communication interface for transmitting the motion data from the data storage device;

[0176] A power supply, wherein the power supply provides power to the motion sensing unit, the data storage device, and the communication interface; and

[0177] An electronic device housing configured to be worn by a patient and connected to the motion sensing unit, the data storage device, the communication interface, and the power supply, wherein the electronic device housing must be permanently deformed in order to transmit motion data from the data storage device or physically access one or more of the power supply.

[0178] 2. The wearable electronic device according to Example 1 includes a band formed of a polymeric compound and connectable to a patient.

[0179] 3. The wearable electronic device according to Example 2, wherein the polymer compound is an elastomer and is integrally formed around the motion sensing unit, the data storage device and the communication interface in a molding process.

[0180] 4. The wearable electronic device according to Embodiment 3, wherein the motion sensing unit, the data storage device, and the communication interface are sealed together with the electronic device housing via the elastomer.

[0181] 5. The wearable electronic device according to embodiment 2, wherein the band includes an elongated portion configured to connect the wearable electronic device to the patient's wrist, wherein the elongated portion and the electronic device housing are integrally formed with the elastomer.

[0182] 6. The wearable electronic device according to Embodiment 1 further includes a power source that is a primary battery.

[0183] 7. The wearable electronic device according to Embodiment 6, wherein the housing of the electronic device must be permanently deformed in order to physically access the power source.

[0184] 8. The wearable electronic device according to Embodiment 7, wherein the motion sensing unit, the data storage device, the communication interface and the primary battery are sealed in the electronic device housing formed of an elastomer.

[0185] 9. The wearable electronic device according to embodiment 6, wherein the motion sensing unit, the data storage device, and the communication interface were previously used in another wearable electronic device, and the power supply was not used in another wearable electronic device.

[0186] 10. The wearable electronic device according to embodiment 6, wherein the primary battery is a metal-air battery, and wherein the wearable electronic device is configured to be sealed in an airtight package to prevent air from reaching the metal-air battery or to have a removable airtight cover to prevent air from reaching the metal-air battery.

[0187] 11. The wearable electronic device according to Embodiment 1, wherein, in order to transmit the motion data from the data storage device, the housing of the electronic device must be permanently deformed to physically access the communication interface.

[0188] 12. A wearable electronic device for collecting motion data from a patient, comprising:

[0189] A motion sensing unit having one or more sensors for sensing motion and outputting motion data based on the sensed motion;

[0190] A data storage device for receiving and storing the motion data;

[0191] A communication interface for transmitting the motion data from the data storage device;

[0192] A controller, the controller being used to operate the motion sensing unit and the data storage device; and

[0193] power supply;

[0194] The wearable electronic device does not include any output device through which the patient can directly observe the output of the wearable electronic device, nor does it include any input device through which the patient can provide conscious input to the wearable electronic device.

[0195] 13. The wearable electronic device according to embodiment 12, wherein the wearable electronic device is configured to not provide any electronic output to any electronic device of the patient, and to not receive any electronic input from any electronic device of the patient.

[0196] 14. The wearable electronic device according to embodiment 13, wherein the wearable electronic device is configured to not provide any electronic output to any electronic device of the prescriber of the wearable electronic device of the patient, and to not receive any electronic input from any electronic device of the prescriber of the wearable electronic device of the patient.

[0197] 15. A method for assessing the activities of multiple patients, comprising:

[0198] Distribute one or more wearable electronic devices from a plurality of wearable electronic devices to each of one or more patients for them to wear;

[0199] When the wearable electronic device is being worn, the patient's motion data is collected by each of the plurality of wearable electronic devices;

[0200] Receive each of the plurality of wearable electronic devices from the patient at the treatment facility; and

[0201] Motion data is transmitted from each of the plurality of wearable electronic devices via a computer data system associated with the processing facility.

[0202] 16. The method according to embodiment 15 further includes processing the motion data via the computer data system to assess the activity of each of the patients.

[0203] 17. The method according to embodiment 16 further includes outputting evaluated activity data to the prescriber of each of the wearable electronic devices via the computer data system.

[0204] 18. The method according to embodiment 15, wherein the receiving includes receiving a wearable electronic device from the patient in a manner that allows for the transport of an individual wearable electronic device among the plurality of wearable electronic devices.

[0205] 19. The method according to embodiment 15 further includes: after receiving, physically processing each of the plurality of wearable electronic devices by permanently deforming the wearable electronic device to provide access to a communication interface of the wearable electronic device, through which the motion data is transmitted from the data storage device of the motion data.

[0206] 20. The method according to embodiment 19, wherein each wearable electronic device includes an electronic component, the electronic component including one or more motion sensors for sensing motion and outputting motion data based on the sensed motion, a data storage device for receiving and storing the motion data, and the communication interface, and the processing includes restoring the electronic component of each wearable electronic device for use in another wearable electronic device among a plurality of other wearable electronic devices.

[0207] 21. The method according to embodiment 20, wherein each of the electronic devices in each wearable electronic device further includes a primary battery, and the restoration includes replacing the primary battery.

[0208] 22. The method according to embodiment 21 further includes distributing one or more wearable electronic devices from a plurality of other wearable electronic devices to one or more different patients.

[0209] 23. According to the method of embodiment 15, after transmitting the motion data from each of the plurality of wearable electronic devices, the method further includes: discarding all electronic components of each wearable electronic device or restoring the data storage device of each wearable electronic device by storing a new unique identifier in the data storage device.

[0210] While the invention has been described in conjunction with certain embodiments, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, consistent with the broadest interpretation to include all such modifications and equivalent structures permitted by law.

Claims

1. A wearable electronic device, comprising: A trigger for activating the wearable electronic device, the trigger being either a physical trigger or an optical trigger; A timer that provides a time indicator; A motion sensing unit that senses motion and outputs motion data based on the sensed motion; as well as A data storage device that receives and stores the motion data or other data derived from the motion data in association with the time indicator; A communication interface through which the motion data or other data, as well as the time indicator, are transmitted from the data storage device to the computing device; An electronic device housing, wherein the communication interface is located within the electronic device housing; wherein, when the wearable electronic device is activated by the trigger, the timer begins to provide the time indicator, and the motion sensing unit begins to operate to sense the motion; The timer continues to provide the time indicator until subsequent data is transferred between the data storage device and the computing device; and The electronic device housing must undergo permanent deformation to transmit the motion data from the wearable electronic device with the communication interface to the computing device.

2. The wearable electronic device according to claim 1, further comprising: power supply; The timer, the motion sensing unit, the data storage device, the communication interface, and the power supply are located within the housing portion; wherein, physical access to the communication interface requires permanent deformation of the housing portion. The trigger activates the wearable electronic device by causing the power source to begin supplying power to the motion sensing unit; and The trigger is a physical trigger and is configured as an electrically insulating element that can move between electrical contacts to shut off the circuit therebetween.

3. The wearable electronic device according to claim 1, wherein, The trigger is the optical trigger and is configured as a light sensor that activates the wearable electronic device after sensing ambient light.

4. The wearable electronic device according to claim 1, wherein, The trigger is the physical trigger and is configured as an electrically insulating element that can move between electrical contacts to shut off the circuit therebetween.

5. The wearable electronic device according to claim 1, wherein, The timer continuously provides the time indicator in order to associate it with the time of day.

6. The wearable electronic device according to claim 1, wherein, The timer, the motion sensing unit, and the data storage device are located within the housing portion.

7. The wearable electronic device according to claim 1, wherein, The housing portion includes removable segments that require permanent deformation of the housing portion to provide physical access to the communication interface.

8. The wearable electronic device of claim 1 further includes a removable segment, the removable segment being removable from the housing portion to provide physical access to the communication interface, the removable segment being a separate element attached to the housing portion.

9. The wearable electronic device according to claim 1, 3 or 4 further includes a power supply, wherein, The trigger activates the wearable electronic device by causing the power source to begin supplying power to the motion sensing unit.

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