US20220399123A1 - Connected body surface care module - Google Patents

Abstract

A wearable treatment and analysis module is provided. The module is positioned on or near a body surface region of interest. The module provides remote access to sensor data, treatment administration, and/or other health care regimens via a network connection with a user device and/or management system.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims priority to U.S. Provisional Patent Application No. 63/202,506, filed on Jun. 14, 2021 and titled “CONNECTED BODY SURFACE CARE MODULE,” U.S. Provisional Patent Application No. 63/266,392, filed on Jan. 4, 2022 and titled “CONNECTED BODY SURFACE CARE MODULE,” and U.S. Provisional Patent Application No. 63/267,475, filed on Feb. 2, 2022 and titled “CONNECTED BODY SURFACE CARE MODULE.” Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference and made part of this specification under 37 C.F.R. § 1.57.
BACKGROUNDField
• This application relates, in general, to a body care device with a sensor device, and in one arrangement, to a wearable body surface care device with a camera.
Description of the Related Art
• There exist various body surface care devices. For example, some devices are used for analysis of skin, such as devices that provide monitoring through imaging and volume measurements.
BRIEF DESCRIPTION OF THE DRAWINGS
• Embodiments of various inventive features will now be described with reference to the following drawings. Throughout the drawings, reference numbers may be re-used to indicate correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the disclosure.
• FIG.1 is a diagram of a network environment including a treatment and analysis module, a management system, and one or more user devices according to some embodiments.
• FIG.2 is a diagram of a treatment and analysis module with a reusable component and a limited use component according to some embodiments.
• FIG.3 is a diagram of a treatment and analysis module with a camera sensor configured to move from a low-profile state, in which a first view is obtained for presentation on a user device, to a raised-profile state, in which a second view is obtained for presentation on the user device.
• FIG.4 is a flow diagram of an illustrative process for analyzing treatment and sensor data and implementing regimens according to some embodiments.
• FIG.5 is a diagram of illustrative data flows and interactions between user devices, a management system, and a treatment and analysis module according to some embodiments.
• FIG.6 is a flow diagram of an illustrative process for analyzing sensor data and contextual data according to some embodiments.
• FIG.7 is a diagram of an illustrative model system for analyzing sensor data and contextual data according to some embodiments.
• FIG.8 is a flow diagram of an illustrative process for analyzing changes in sensor data and contextual data according to some embodiments.
• FIG.9 is a perspective, exploded view of an embodiment of the module and an associated fitted wrap.
• FIG.10 is a perspective view of another embodiment of the module attached to a patient by an adhesive pad.
• FIG.11 is a perspective view of the module embodiment ofFIG.9, shown fully assembled and attached to a patient with conventional bandages and gauze.
• FIG.12 is a perspective view of the module embodiment ofFIG.9, shown fully assembled and attached to a patient with a conventional wrap.
• FIG.13A is a top plan view of another embodiment of the treatment and analysis module that comprises a housing forming a receptacle.
• FIG.13B is a cross-section view through the module inFIG.13A showing a camera sensor and a battery disposed in the receptacle of the housing.
• FIG.14A is a left isometric view of the module fromFIG.13A showing a platform of the housing configured to be secured relative to a patient.
• FIG.14B is a right isometric view of the module fromFIG.13A.
• FIG.15A is a back isometric view of the module fromFIG.13A showing an aperture in a cover aligned with a camera lens of the camera sensor.
• FIG.15B is a back isometric view similar toFIG.15A except the cover is opaque.
• FIG.16A is another back isometric view of the module fromFIG.13A.
• FIG.16B is another back isometric of the module fromFIG.13A.
• FIG.17 is an exploded view of the module fromFIG.13A showing the sensor module and the battery removed from the receptacle.
• FIG.18 is another exploded view of the module fromFIG.13A showing the sensor module and the battery removed from the receptacle.
• FIG.19A is a back plan view of the module fromFIG.13A showing the aperture in the cover aligned with the camera lens of the sensor module.
• FIG.19B is a back plan view similar toFIG.19A except the cover is opaque.
• FIG.20 is a schematic view of the module fromFIG.13A.
• FIG.21A is a plan top view of the PCB fromFIG.13A.
• FIG.21B is a back side view of the PCB fromFIG.21A.
• FIG.22A is a perspective view of the PCB fromFIG.13A.
• FIG.22B is a front plan view of the PCB fromFIG.13A.
• FIG.22C is a side view of the PCB fromFIG.22B.
• FIG.22D is an upper plan view of the PCB fromFIG.13A.
• FIG.23A is a top plan view of another embodiment of the treatment and analysis module that is similar to the module ofFIG.13A except the housing comprises one or more legs in an extended configuration.
• FIG.23B is a cross-section view through the module inFIG.23A showing the one or more legs in the extended configuration.
• FIG.24A is a top plan view of the module fromFIG.23A showing the one or more legs in the extended configuration.
• FIG.24B is a top plan view similar toFIG.24A except the one or more legs are in the retracted configuration.
• FIG.25A is a back plan view of the module fromFIG.23A showing the one or more legs extending beyond an outer perimeter of the platform when in the extended configuration.
• FIG.25B is a back plan view similar toFIG.25A except the one or more legs are in the retracted configuration hidden behind the platform.
• FIG.26A is a left isometric view of the module fromFIG.23A showing the one or more legs in the extended configuration.
• FIG.26B is a right isometric view of the module fromFIG.23A showing the one or more legs in the extended configuration.
• FIG.27A is a top plan view of another embodiment of the treatment and analysis module that is similar to the module ofFIG.23A except the one or more legs extend from the housing at a location below the platform.
• FIG.27B is a cross-section view through the module inFIG.27A showing the one or more legs in the extended configuration.
• FIG.28A is a back plan view of the module fromFIG.27A showing the one or more legs in the extended configuration.
• FIG.28B is a back plan view similar toFIG.28A except the one or more legs are in the retracted configuration.
• FIG.29A is a left isometric view of the module fromFIG.27A showing the one or more legs in the extended configuration.
• FIG.29B is a right isometric view of the module fromFIG.27A showing the one or more legs in the extended configuration.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
• The present disclosure is directed to a wearable treatment and analysis module that is positioned on or near a body surface region of interest. The module provides remote access to sensor data, treatment administration, and/or other health care regimens via a network connection with a user device and/or management system.
• Some conventional systems use sensors to measure aspects of body surface regions. Other conventional systems facilitate administration of treatment to body surfaces. However, such systems may not be remotely accessible and/or controllable. Moreover, use of wearable medical articles such as bandages, casts, and the like may inhibit use of such sensor systems and treatment systems.
• Some aspects of the present disclosure address one or more of the issues noted above, among others, by providing a treatment and analysis module configured to be mounted to a bandage, wrap, cast, or other wearable medical article and positioned in proximity to a body surface region of interest, such as a wound (e.g., from an injury, disease, or surgery). The treatment and analysis module is remotely accessible to facilitate access to sensor data, treatment instructions, and the like. Thus, the treatment and analysis module aids health care professionals in monitoring and managing the treatment for post-surgical patients or patients with wounds or other skin conditions without removing the bandage, wrap, or cast. The remote monitoring and treatment management provided by the treatment and analysis module also allows for accelerated patient discharge from medical facilities.
• Additional aspects of the present disclosure provide automated analysis of sensor data to detect body surface conditions. In some embodiments, machine learning models may be trained and used to detect body surface conditions (e.g., wounds, diseases, etc.), to determine the severity of the conditions, and/or to evaluate the change in the body surface conditions over time. For example, image analysis models may be used to classify images as depicting various body surface conditions. As another example, scoring models may be used to grade the degree and/or severity of the body surface conditions. In some embodiments, different machine learning models may be trained and targeted for use in classifying or otherwise evaluating different types of wounds, such as wounds from different types of injuries and/or surgeries. For example, sensor data from a particular treatment and analysis module regarding a particular type of wound may be evaluated using one machine learning model or set of models, while sensor data from a different treatment and analysis module regarding a different type of wound may be evaluated using a different machine learning model or set of models.
• Further aspects of the present disclosure provide wearable medical articles and/or treatment and analysis modules configured for particular types of wounds or other applications. In some embodiments, a treatment and analysis module configured for a particular type of wound may include a particular set of one or more sensors that provide data that is advantageous in monitoring and/or treating the particular type of wound. A treatment and analysis module configured for a different type of wound may include a different set of sensors that provide data advantageous in monitoring and/or treating the different type of wound. The sets of sensors may be different such that one set of sensors may include additional, fewer, and/or alterative sensors or sensor configurations than the other set of sensors. Differences between different wearable medical articles and/or treatment and analysis modules are not necessarily limited to different sensor configurations. In some embodiments, a wearable medical article and/or treatment and analysis module may be sized and/or shaped to target or be suitable for a particular type of wound. In some embodiments, a wearable medical article and/or treatment and analysis module may be sized, shaped, or otherwise configured for robotic placement. For example, a treatment and analysis module may include features such as structural registration points, alignment aids, or the like to facilitate being held, manipulated, and placed by a medical robot onto or near a wound.
• Various aspects of the disclosure will now be described with regard to certain examples and embodiments, which are intended to illustrate but not limit the disclosure. Although the examples and embodiments described herein will focus, for the purpose of illustration, on specific devices, data, treatments, and algorithms, one of skill in the art will appreciate the examples are illustrative only, and are not intended to be limiting, essential, or exhaustive. In addition, any feature, process, device, or component of any embodiment described and/or illustrated in this specification can be used by itself, or with or instead of any other feature, process, device, or component of any other embodiment described and/or illustrated in this specification.
Example Network Environment for Remote Access to Treatment and Analysis Module
• FIG.1 shows a network environment including a treatment andanalysis module100, a management system120, and one or more user devices130. The individual devices may communicate via one or more communication networks140.
• A communication network140—also referred to simply as a “network”—may be a publicly accessible network of linked networks, possibly operated by various distinct parties, such as the internet. In other embodiments, a network140 may include a private network, personal area network, local area network, wide area network, cable network, satellite network, cellular telephone network, etc. or a combination thereof, some or all of which may or may not have access to and/or from the internet.
• The treatment andanalysis module100 may be, or be part of, a personal care system. The treatment andanalysis module100 may include various modules, components, and data stores to implement monitoring of characteristics of a user tissue or other body surface region (e.g., epidermis, oral mucosa, dental enamel, etc.), application of treatments (e.g., topical fluids, ozone, ultraviolet light, negative pressure wound therapy, etc.), and communication of monitoring and treatment information to and/or from other devices and systems, such as the management system120 and/or user devices130.
• The treatment andanalysis module100 may include one ormore sensors102 to monitor and generate data regarding user skin characteristics. In some embodiments, the one ormore sensors102 may include a visualization element, such as a camera sensor, to capture images and/or generate other visualization data regarding the skin of a user. Such visualization data may be used to monitor a wound or other skin aspect over time, to diagnose a skin condition, to determine a treatment for a skin condition, and/or to monitor the treatment of a skin condition over time. In some embodiments, the one ormore sensors102 may also or alternatively include a temperature sensor to determine the temperature of the user's body surface region and/or the ambient temperature. In some embodiments, the one ormore sensors102 may also or alternatively include an accelerometer to assess movements and activities of the patient. In some embodiments, the one ormore sensors102 may also or alternatively include a pH sensor to determine the pH level of the user's body surface region. In some embodiments, the one ormore sensors102 may also or alternatively include a moisture sensor to determine the moisture content of the user's body surface region and/or the ambient moisture around a location of the user's body surface region. In some embodiments, the one ormore sensors102 may also or alternatively include a pressure sensor to determine the pressure, such as pressure within a cast, bandage, or other enclosure to which the treatment andanalysis module100 is mounted. Theexample sensors102 described herein are illustrative only, and are not intended to be limiting, required, or exhaustive of thesensors102 that may be included in a treatment andanalysis module100. In some embodiments, one treatment andanalysis module100 may be configured for use with a particular type of suture site or other wound, and may include a particular set of one ormore sensors102 that provide data that is advantageous in monitoring and/or treating the particular type of wound. Another treatment and analysis module configured for a different type of suture site or other wound may include a different set of sensors (e.g., additional, fewer, and/or alterative sensors or sensor configurations).
• The treatment andanalysis module100 may include aprocessor104, such as a system on a chip (“SOC”) or other microprocessor to process data and commands. In some embodiments, theprocessor104 may process data from one ormore sensors102 and/or thedata store106, execute one or more analysis or detection algorithms, receive and execute commands from other devices via anetwork interface108, or the like. In some embodiments, thedata store106 may be a substantially persistent data store, such as flash memory, hard disk, or the like. Thenetwork interface108 may be a wired or wireless network interface, such as a network adapter card and/or a wireless antenna (e.g., a Wi-Fi antenna, a Bluetooth® antenna, etc.).
• The treatment andanalysis module100 may include components to store and administer treatment to the body surface region of a user. For example, treatment may be a topical fluid, such as a spray, lotion, ointment, or gas. The fluid treatment may be stored in afluid treatment storage112, and dispensation of the fluid treatment may be performed using atreatment dispenser110. In some embodiments, thefluid treatment storage112 may be a fluid-tight container in fluid communication with thetreatment dispenser110. Thetreatment dispenser110 may include an aperture through which fluid from thefluid treatment storage112 can be dispensed onto a body surface region of a user. In some embodiments, thetreatment dispenser110 may include or be controlled by a mechanical actuator to actively expel fluid treatment (e.g., to urge fluid from a nozzle) or to permit the release of pressurized fluid treatment (e.g., to open a valve to allow fluid to pass). As another example, treatment may include waveform-based treatments, such as ultraviolet light or ultrasound. Thetreatment dispenser110 for such treatments may include corresponding emission devices, such as ultraviolet light emitting diodes (“LEDs”) and/or ultrasonic transducers.
• In some embodiments, the treatment andanalysis module100 may be a removable component of a home-use hand-held personal care device such as, for example, a facial beauty device or hair apparatus. With reference to an illustrative embodiment of such a home-use hand-held personal care device (disclosed in U.S. Patent Application Publication No. 2020/0280680, which is incorporated by reference herein and forms part of this disclosure), the personal care device may include a platform that allows for application of a various modules. The platform may be adapted to incorporate aspects of the present disclosure, such as permitting application of the treatment andanalysis module100 instead of, or in addition to, a separate camera, and/or a second treatment dispenser for other treatments (e.g., a brush, an energy-delivery applicator, etc.). A user can attach a module to the personal care device at the platform, analyze and/or treat skin or other body surface region with the personal care device using the attached module, remove the module from the platform, attach a second module at the platform, etc. In some embodiments, the treatment andanalysis module100 may be configured for permanent or semi-permanent incorporation within an exterior housing of personal care devices. For example, the sensor(s)102,processor104,data store106, and/ornetwork interface108 may be integrated into or coupled to a circuit board. In this configuration, the circuit board assembly and other components of themodule100 may be installed within the housing of a personal care device, such as a negative pressure wound therapy device, optical coherence tomography device, or micro-elastography device.
• In some embodiments, the treatment andanalysis module100 may be a removable component of a personal wound care device, such as a bandage or cast. The treatment andanalysis module100 may be removably integrated with, mounted to, or otherwise attached to the personal wound care device and positioned on or near a region of interest, such as a suture site or other wound. The position may be selected to facilitate visualization of the region of interest (e.g., via a camera sensor), monitor other aspects of the region of interest (e.g., via other sensors such as a temperature and/or moisture sensor), and/or apply fluid treatment to the region of interest. Examples of personal wound care devices are described below.
• In some embodiments, treatment and analysis module100 (or a wearable medical article to which the treatment andanalysis module100 is coupled) may be sized and/or shaped to target a particular type of wound. For example, one or more dimensions (e.g., length, width, height) of the treatment andanalysis module100 may be configured based on one or more dimensions of, or the severity or type of wound present on, the body surface region on which the treatment andanalysis module100 is to be placed. In some embodiments, a treatment andanalysis module100 may be sized, shaped, or otherwise configured for robotic placement. For example, a treatment andanalysis module100 may include features such as structural registration points, alignment aids, or the like to facilitate being held, manipulated, and placed by a robotic surgical system onto a body surface region.
• In some embodiments, the treatment andanalysis module100 or components thereof may be designed for a single use or otherwise for a limited quantity or duration of use. For example, if portions of the treatment andanalysis module100 come into physical content with a region of a user's body surface (e.g., a wound, dental enamel, or oral mucosa), the treatment andanalysis module100 as a whole may be limited use. As another example, components of the portions of the treatment andanalysis module100 that contact the body surface region may be limited use, while other portions of the treatment and analysis module may be reusable. As a further example, portions of the treatment andanalysis module100, such as thefluid treatment storage112, may include exhaustible resources. Such portions may be refillable or replaceable. Examples and details of limited-use treatment andanalysis modules100 or components thereof are shown inFIG.2 and described in greater detail below.
• The management system120 may include various components for providing the features described herein. Illustratively, the management system120 may include an analysis component122 to process data received from the treatment and analysis module100 (e.g., sensor data, treatment data, etc.), determine treatment instructions, and the like. The management system120 may also include a portal server124 that may be configured to provide access to results generated by the analysis component122, receive instructions or other input regarding the analysis or treatments, and the like. The management system120 may also include a data store126 that maintains data regarding treatments, results, users, and the like. The example components and data stores of the management system120 shown inFIG.1 are illustrative only, and are not intended to be limiting, required, or exhaustive. In some embodiments, a management system120 may have fewer, additional, and/or alternative components and data stores.
• The management system120 may be implemented on one or more physical server computing devices that provide computing services and resources to treatment andanalysis modules100 and user devices130. In some embodiments, the management system120 (or individual components thereof, such as the analysis component122, portal server124, data store126, etc.) may be implemented on one or more host devices, such as blade servers, midrange computing devices, mainframe computers, desktop computers, or any other computing device configured to provide computing services and resources. For example, a single host device may execute one or more analysis components122, one or more portal servers124, one or more data stores126, some combination thereof, etc. The management system120 may include any number of such hosts.
• In some embodiments, the features and services provided by the management system120 may be implemented as web services consumable via communication network140. In further embodiments, the management system120 (or individual components thereof) is provided by one or more virtual machines implemented in a hosted computing environment. The hosted computing environment may include one or more rapidly provisioned and released computing resources, such as computing devices, networking devices, and/or storage devices. A hosted computing environment may also be referred to as a “cloud” computing environment.
• The individual user devices130 may be any of a wide variety of computing devices, including personal computing devices, terminal computing devices, laptop computing devices, tablet computing devices, electronic reader devices, wearable computing devices, mobile devices (e.g., smart phones, media players, handheld gaming devices, etc.), and various other electronic devices and appliances. A user device130 may be used to access data generated by a treatment andanalysis module100 or management system120, to provide data and/or instructions to a treatment andanalysis module100 or management system120, etc.
• The treatment andanalysis module100, also referred to herein as a “wearable module” or “module,” can be controlled or monitored by application software executing on a user device130. In some embodiments, an individual who is wearing or operating a treatment and analysis module100 (e.g., as part of a hand-held personal care device or a personal wound care device) may use a user device130 to interact with the treatment andanalysis module100. In some embodiments, an individual who is remotely managing or operating a treatment and analysis module100 (e.g., a health care professional monitoring and managing the care of a patient wearing a personal wound care device or operating a hand-held personal care device) may use a user device130 to interact with the treatment andanalysis module100 and/or the management system120. In some embodiments, application software to interact with the treatment andanalysis module100 and/or management system120 may be provided to the user device130 over a network connection. For example, a user may enter a code or scan an encoded image (e.g., a barcode, quick response or “QR” code, or the like) and be directed to a network resource (e.g., a server on the internet or an intranet) from which the application software may be downloaded. As another example, a user may manually access a network resource and download the application software.
• With reference to an illustrative embodiment, the treatment andanalysis module100 may include an application programming interface (“API”). The API can be implemented within or called by the user device130 using the software application. It will be appreciated that themodule100, user device130, and/or management system120 may communicate with each other via the network140 using specialized API calls that enable one of the modules, devices, or systems to request that another module, device, or system generate responsive data to be returned via an API response. It will be further appreciated that particular aspects or functionality of the API described herein may be implemented at different modules, devices, or systems illustrated inFIG.1. For example, the user device130 may implement aspects of the API related to generating user interfaces that display images captured by themodule100, while a management system120 may implement aspects of the API that employ one or more machine learning models to analyze images provided to the management system120 by themodule100 or user device130. The particular module, device, or system that implements particular functionality described herein, such as functionality or features described herein as being provided by the API, may depend on the processing capabilities of the given device in the given embodiment. For example, a user device130 may be configured to execute image analysis locally or to request that such image analysis be performed remotely at the management system120, depending on the configuration of the management system120, or on the processing capabilities of a particular user device130 (e.g., desktop computer, mobile phone) on which the application is operating.
• In some embodiments, an API and/or application software executing on one or more of themodule100, management system120, or user device130 can provide any or all of following functionalities: power on or off themodule100; take before and after images via a camera sensor of themodule100; instruct the user through the user device130 on how to perform functions of the module100 (e.g., take images, store or access image files, schedule treatment regimens); display images on the user device130, singularly or side-by-side, captured by a camera sensor of themodule100; calculate and monitor measurements of aspects of a region of a user's body surface (e.g., wound area, wound volume, lesion area, lesion volume, wrinkle depth, fine line frequency, epidermal layer exfoliation, skin hydration) based on data provided by one or more sensors of themodule100; and/or provide detailed images to the management system120 or another user device130 for evaluation.
• The management system120 and/or user device130 can process images from a camera of themodule100. In some arrangements, an API can be used for capturing an image with acamera sensor102. Thecamera sensor102 can use the API to provide image data via Wi-Fi or Bluetooth to the management system120, a user device130, other devices, or some combination thereof. For example, application software executing on a user device130 can allow a user to program or control the operation of themodule100 via an API. Themodule100 can provide for acquisition of a digital image of a region of a user's body surface at an increased magnification, such as at a magnification of about: 2×, 10×, 50×, 400×, and various intermediate values. In some embodiments, as described in greater detail below with respect toFIG.3, themodule100 includes a camera sensor with zoom-in functionality that increases the magnification of the camera.
• In some embodiments, themodule100 includes a holographic high-resolution camera sensor configured to provide non-line-of-sight (“NLoS”) imaging. For example, the camera sensor may use synthetic wavelength holography in which light is indirectly scattered onto objects, including objects that may not be imaged using a conventional camera sensor due to being partially or completely obstructed by tissue (e.g., skin, bone, muscle) or other objects. Scattered light captured by a holographic camera sensor may be used to construct an image that exposes partially or completely obscured regions of interest.
• In some embodiments, themodule100 includes a three-dimensional wound assessment monitor (“3D-WAM”) camera sensor. Advantageously, such a camera sensor is able to measure wound size in three dimensions. A laser, such as a vertical-cavity surface-emitting laser (“VCSEL”), works in the near-infrared spectroscopy (“NIR”) range (e.g., 940 nm) to generate 2D and 3D data in one shot with a multipart image, incorporating range, intensity and confidence maps.
• Themodule100 may generate digital photographs that one or more user devices130 or the management system120 can analyze to determine information relating to a condition of the skin, such as, for example, wound size, wound shape, wound depth, wound color, debris in the wound, etc. Storage of images (e.g., in adata store106 of themodule100 or a data store126 of the management system120) can enable presentation of “before-and-after” visual results via a user interface displayed by a user device130. For example, a user such as a wearer of themodule100 or a health care professional can cause themodule100 to take a “before” image before treating a body surface region, then cause dispensation of treatment to the body surface region via thetreatment dispenser110, and then cause the module to take an “after” image of the body surface region. In this way, themodule100 and remote access to images captured by themodule100 can be used to provide a recovery tracker that allows a user to evaluate a treatment administered to a body surface region. For example, a user can use themodule100 to take a series of images of the body surface region over the course of time (e.g., over days, weeks, months) and compare the images to one another to evaluate whether a treatment regimen applied to the body surface region is effective at improving a condition (e.g., wound healing). In some embodiments, themodule100 can allow a user to watch live digital image and/or video feed on a user device130.
Example Treatment and Analysis Module
• With reference toFIG.2, illustrative embodiments of a treatment andanalysis module100 will be described. In some embodiments, as shown, a portion of the treatment andanalysis module100 can be implemented as a limited use component202. For example, the limited use component202 may be configured to contact or otherwise be exposed an oral surface of a user (e.g., dental enamel, dentin, oral mucosa), a wound of a user, or some other body surface region. Such exposure may be advantageous for the operation of certain components of the treatment andanalysis module100, such as one or more of thesensors102 or atreatment dispenser110. By implementing such components as (or as a part of) a limited use component202, contamination via exposure to a region of a user's body surface can be minimized through limited use of the content(s). As another example, the limited use component202 may be or include a reservoir for an exhaustible resource, such as afluid treatment storage112. By implementing such components as (or as a part of) a limited use component202, mechanisms to replenish the exhaustible resource do not need to be incorporated. Rather, the limited use component202 can be replaced with a new component202 that has a fresh supply of the exhaustible resource.
• The limited use component202 may be removably attached to a reusable substrate for use. In some embodiments, the treatment andanalysis module100 may include areusable component200 to which the limited use component202 may be removably attached. The reusable component may include additional components of the treatment andanalysis module100 that are not included in the limited use component202 or that may be alternatives to components of the limited use component202. For example, the reusable component may include more durable and/or expensive components of the treatment andanalysis module100, such as theprocessor104,data store106, andnetwork interface108. One ormore sensors102 may also be included, such as those that do not need direct contact or exposure to the body surface region of the user (e.g., a motion sensor, an ambient moisture sensor, an ambient temperature sensor). In some embodiments, one ormore sensors102 that do require exposure to the body surface region of the user may be included in the reusable component202. For example, a camera sensor may be included the reusable component202 due to the expense, complexity, and/or other characteristics of the camera for which limited use and replacement may not be desirable. In these arrangements, the limited use component202 may include a protected exposure portion, such as a sealed window or filtered aperture, through which the sensor of thereusable component200 may gain exposure to a body surface region of the user.
• In certain arrangements, thereusable component200 or the treatment andanalysis module100 as a whole can be waterproof or water-resistant, allowing thereusable component200 ormodule100 to be submerged or brought into contact with water without damage. For example, themodule100 can be adapted to allow a user to use themodule100 in a shower or a bathtub. The housing of themodule100 can form a water-tight seal that prevents water from entering the internal space of themodule100, thereby protecting the internal electronics of themodule100 from being contacted by water. The housing of themodule100 can form a water-tight seal with the personal care device to which the module is attached.
• FIG.3 illustrates a treatment andanalysis module100 with a camera sensor102A configured to move from a low-profile state to a raised-profile state. In the low-profile state, shown in the upper half of the diagram, a first view of a body surface region300 is obtained, showing surface portions ofinterest302 and304. In the raised-profile state, shown in the lower half of the diagram, a second view is obtained showing a zoomed-in view of portion ofinterest302. In some embodiments, the first view may be a wider-angle view than the second view due to the optical configuration of the camera sensor102A. For example, the camera sensor102A may be configured to transition from the low-profile state to the raised profile state in order to zoom in on a particular subregion of the body surface region300. The transition may be caused by manual application of force (e.g., a user turns a zoom ring, applies pressure, etc.). In some embodiments, themodule100 and/or thecamera sensor102 may include a motorized subsystem for transitioning from the low-profile state to the raised-profile state and vice versa. Images captured in the different states may show wide-angle and zoomed-in views, respectively, on a user device130.
Example Process for Use and Management of Operation of Module
• FIG.4 is a flow diagram of an illustrative process400 that may be executed to use and/or manage the operation of a treatment andanalysis module100. The process400 or portions thereof may be executed by a user device130 and/or management system120, individually or in combination. Advantageously, execution of the process400 allows for remote access to data generated by a treatment andanalysis module100, and remote control of operations of the treatment andanalysis module100. For example, the process400 allows for implementation and analysis of a monitoring regimen in which sensor data is generated for analysis. As another example, the process400 allows for implementation of a treatment regimen in which a treatment is administered to a wearer of themodule100. The wearer of themodule100 may also be referred to as a “subject” of the sensor data generated by and/or treatment administered by themodule100.
• Portions of the process400 will be described with further reference to the illustrative data flows and interactions between the treatment andanalysis module100, management system120, clinician user device130A, and patient user device130B shown inFIG.5.
• The process400 begins at block402. The process400 may begin in response to an event, such as when a clinician device130A connects to the management system120 to initiate a regimen for use of the treatment andanalysis module100. In some embodiments, process400 or portions thereof may be performed on a predetermined or dynamically-determined schedule. For example, output data from the module100 (images and/or other sensor data) may be obtained periodically, such as hourly, daily, or weekly. Themodule100 may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120 or a user device130 may request the output data from themodule100. In some embodiments, process400 or portions thereof may be performed on-demand, such as when a user interacts with themodule100, a clinician device130A, or a patient device130B. In this way, process400 may produce real time or substantially real time implementation and analysis. When the process400 is initiated, a set of executable program instructions stored on one or more non-transitory computer-readable media (e.g., hard drive, flash memory, removable media, etc.) may be loaded into memory (e.g., random access memory or “RAM”) of a computing device, such as a computing device of management system120. In some embodiments, the process400 or portions thereof may be implemented on multiple processors, serially or in parallel.
• At block404, the system executing the process400 may determine a regimen for use of themodule100. In one embodiment, a regimen may specify a treatment to be administered by themodule100. For example, themodule100 may be configured to administer a topical fluid, such as a spray, lotion, or ointment. Administration of the treatment may be a one-time on-demand administration, or it may be scheduled for one or more future times according to a predetermined or dynamically determined schedule. In another embodiment, a regimen may specify sensor data to be generated, stored, and/or transmitted to a separate system such as the management system120 or user device130. For example, the regimen may specify a set of one or more sensor data items to be generated and transmitted. Generation and transmission of the set of sensor data items may be specified as a one-time on-demand process, or may be scheduled for one or more future times according to a predetermined or dynamically determined schedule.
• Determination of the regimen may be based on a selection or other input from a user, such as a wearer of themodule100 or a health care professional. For example, a user device130 (e.g., a clinician device130A or a patient device130B) may present regimen options that can be selected and implemented. A user may activate an option, and the activation may indicate determination of the particular regimen to be implemented.
• In some embodiments, the regimen may be automatically generated or suggested using a recommendation algorithm. The recommendation algorithm may take input, such as information regarding the subject (e.g., demographic information, information regarding the current state of the user's body surface region being monitored and/or treated, etc.) and/or information regarding treatments used by the subject. For example, the recommendation algorithm may be a collaborative filtering algorithm, a content-based filtering algorithm, or a combination of algorithms.
• In a collaborative filtering implementation, a model may be trained to generate recommendations of treatments or other regimens that were effective for similar subjects. The model may be used to evaluate information about the subject, such as features derived from the subject's demographic information and/or information regarding the current state of the user's body surface region being treated. The model may then output a recommendation of a treatment or other regimen that was effective for other subjects with same or similar features.
• In a content-based filtering implementation, a model may be trained to generate recommendations of treatments or other regimens that are similar to treatments or other regimens used by the subject. The model may be used to evaluate information about the subject, such as features derived from the subject's prior treatment history (e.g., treatments that were effective) or the subject's stated treatment preferences. The model may then output a recommendation of a treatment or other regimen with the same or similar features.
• At block406, the system executing the process400 may send regimen instructions to themodule100. In some embodiments, regimen instructions may be sent in the form of an executable function call and/or data identifying the regimen. For example, the data may represent a treatment identifier, treatment quantity, scheduled treatment time(s), sensor identifier, scheduled sensor data recording/transmission time(s), etc.
• FIG.5 illustrates an example in which a clinician device130A generates and transmits regimen instructions to the management system120 at [1]. The management system120 then provides the regimen instructions to the treatment andanalysis module100. As shown, the treatment andanalysis module100 may be positioned on a subject via a module mount500, such as a bandage, cast, strap, or other wearable medical article to which themodule100 is coupled. For example, the mount500 may be worn such that themodule100, or individual sensors thereof (e.g., a camera sensor), is positioned over a particular body surface region of interest, such as a wound.
• In some embodiments, the regimen instructions generated by the clinician device130 may reference, include, or otherwise be associated with an identifier of a destination for the regimen instructions. For example, a unique account identifier of a user account of the wearer of the module100 (e.g., a user account of a patient under the care of a clinician operating the clinician device130A), or a unique identifier of themodule100 itself, may be selected or otherwise specified by the operator of the clinician device130A. In some embodiments, the unique identifier may be numeric, or alpha-numeric. The management system120 may maintain communication data that specifies where or how communications are to be sent to themodule100 identified in connection with the regimen instructions. For example, communication data associated with the identifier of the destination for the regimen instructions may be an internet protocol (“IP”) address of a recipient, such as themodule100 or patient device130B. Using this communication data, the management system120 may transmit the regimen instructions. Instructions may be transmitted directly to themodule100 if the module is configured with network communication capabilities and is accessible to the management system120. In some implementations, instructions may be transmitted to an intermediary device that is in communication with themodule100, such as the patient device130B, indicated as [1′]. A communication path between the patient device130B andmodule100 can be established to provide the regimen instructions, or data derived therefrom, to themodule100.
• Returning toFIG.4, at block408 the system executing the process400 may obtain data from themodule100. The data may include sensor data, data regarding a treatment administered by themodule100, other data, or some combination thereof. In some embodiments, sensor data may be or include an image of a body surface region of the wearer of themodule100, a temperature of the body surface region, an ambient temperature, a measurement of moisture of the body surface region, a measurement of ambient moisture, a measurement of pH of the body surface region, other measurements, or some combination thereof. In some embodiments, treatment data may represent a confirmation of application of the treatment, a quantity of treatment administered, or the like.
• The system executing the process400 (e.g., management system120 or a user device130) may obtain the data automatically, on demand, or in response to an event. For example, a clinician device130A may request output data from themodule100. The request may be sent to the management system120, which may provide the request to themodule100 directly or via an intermediary such as the patient device130B, in a manner similar to that described with respect to providing regimen instructions. Themodule100 may generate, access, or otherwise obtain the requested data and provide it to the requesting device. For example, as shown inFIG.5, themodule100 may generate and provide output data (e.g., an image) at [2] to a clinician device130A, directly or via the management system120. As another example, the module may generate and provide output data at [2′] to a patient device130B, which may or may not send the output data to the clinician device130A, directly or via the management system120.
• At block410, the system executing the process400 may analyze the module output data. Analysis of the module output data may be performed (e.g., at the management system or a user device130) using one or more models to determine one or more metrics, conditions, states, and/or recommendations. In some embodiments, an image analysis model system may be used to determine a current state of a body surface region or a change over time of the body surface region, as described in greater detail below. Data regarding the current state and/or change over time of the body surface region may in some embodiments be used to generate a recommendation such as a recommendation regarding a treatment to be administered.
• In some embodiments, different machine learning models may be trained and targeted for use in classifying or otherwise evaluating different types of wounds, such as wounds from different types of injuries and/or surgeries. For example, a clinician may access the management system120 via clinician device130A and specify a type of surgery that was performed and/or a type of wound being analyzed. The clinician may do so at various times, such as when the treatment andanalysis module100 is first configured for the patient, or when data is received for analysis. The management system120 may select, based on the specified surgery or wound type, a model or set of models to use to analyze sensor data from the treatment andanalysis module100. Other surgeries and/or wounds may result in selection of different models, and in some cases may result in evaluation of different sensor data. To facilitate automated and consistent use of models targeted for particular surgeries or wounds, the management system120 may maintain data that maps surgery/wound types to models, sensor data, and the like.
• At decision block412, the management system120 or a user device130 may determine whether to continue an existing regimen. If so, the process400 may return to block408 for acquisition and analysis of further module output data, such as after administration of another treatment, after passage of a period of time, etc. Otherwise, if the existing regimen is not to continue, the process400 may proceed to decision block414.
• In some embodiments, a decision of whether to continue an existing regimen may be based on a recommendation for a treatment or other aspect of the regimen, such as a recommendation (e.g., generated as described in greater detail above with respect to block404). If the recommended treatment and/or other aspect of the regimen is the same, the existing regimen may continue. In some embodiments, a decision of whether to continue an existing regimen may be based on a classification and/or a score representing the current state of the subject's body surface region, such as a classification and/or score generated as described in greater detail below. In some embodiments, the decision may be based on a change in classification and/or score representing the current state of the subject surface region over time. An example process for determining such a change is described in greater detail below.
• The decision of whether to continue an existing regimen may be interactive. For example, classification data, scoring data, and/or treatment recommendations may be generated and displayed on an interface of a clinician device130A or patient device130B. A user of the device displaying the information may determine whether to continue the existing regimen, and activate a user interface control representing the decision (e.g., a button to continue or a button to stop the current regimen). Depending upon the selected option, the current regimen may be continued or stopped.
• In some embodiments, as shown inFIG.5, the clinician device130A may communicate with the patient device130B at [3]. The communications may include text, video, and/or audio interactions between users of the devices130A and130B. For example, a user of a clinician device130A may communicate with the subject using the patient device130B to discuss an analysis of module output data, treatment regimens, or the like. Based on these communications, the user of the clinician device130A and/or the subject using patient device130B may determine whether or not to continue an existing regimen, and may indicate the determination on a user interface of the respective device130A or130B. In some embodiments, the clinician device130A and/or patient device130B may prompt for or otherwise receive input regarding post-operative pain (e.g., a pain score), range of motion, swelling, total blood loss, pre- and post-operative hematocrit level differences, or the like. Such input may be stored at the clinician device130A, patient device130B, and/or management system120 for use in determining and monitoring a treatment regimen.
• At decision block414, the management system120 or a user device130 may determine whether to change the regimen that is to be performed by themodule100. If so, the process400 may return to block404, where the new regimen or change to existing regimen is determined. Otherwise, if treatment is not to continue, the process400 may terminate at block416.
• In some embodiments, a decision of whether to change an existing regimen may be based on a classification and/or a score representing the current state of the subject's body surface region, or on a change in such classification and/or score, as described above. In some embodiments, the decision of whether to continue an existing regimen may be interactive, as described above. For example, the determination may be made based on classification, scoring, or other analysis results generated and displayed on an interface of a clinician device130A or patient device130B, communications between a clinician device130A and patient device130B, etc. Based on the displayed data and/or communications, the user of the clinician device130A and/or the patient device130B may determine whether or not to change the existing regimen or stop the regimen.
Example Process for Image Analysis and Scoring
• FIG.6 is a flow diagram of an illustrative process600 that may be executed to analyze image(s) obtained from themodule100. Analysis of an image of a patient body surface may include a comparison of the image to a database of images of “normal” results and “concerning” results, and/or use of a model trained based on such images. In some embodiments, a concerning result may cause generation of a message to the patient to submit images and analytics to a clinician (e.g., a doctor or other medical practitioner). In some embodiments, a concerning result may cause generation of a message to a clinician (e.g., rather than instructing the patient to do so).
• In some embodiments, different machine learning models may be trained and targeted for use in classifying or otherwise evaluating different types of wounds, such as wounds from different types of injuries and/or surgeries. For example, a clinician may access the management system120 via clinician device130A and specify a type of surgery that was performed and/or a type of wound being analyzed. The clinician may do so at various times, such as when the treatment andanalysis module100 is first configured for the patient, or when data is received for analysis. The management system120 may select, based on the specified surgery or wound type, a model or set of models to use to analyze images (and, in some cases, other sensor data) from the treatment andanalysis module100. Other surgeries and/or wounds may result in selection of different models. To facilitate automated and consistent use of models targeted for particular surgeries or wounds, the management system120 may maintain data that maps surgery/wound types to models.
• The process600 or portions thereof may be executed by a user device130 and/or management system120, individually or in combination. For example, process600 may be performed to analyze module output data from themodule100, such as during block410 of process400. Portions of the process600 will be described with further reference to the illustrative imageanalysis model system700 shown inFIG.7.
• The process600 begins at block602. The process600 may begin in response to an event, such as when the management system120 obtains an image captured by themodule100, when a user device130 connects to the management system120 to initiate analysis of an image (or set of images) captured by themodule100, or on a predetermined or dynamically-determined schedule. In some embodiments, process600 or portions thereof may be performed on a predetermined or dynamically-determined schedule. For example, output data from the module100 (images and/or other sensor data) may be obtained periodically, such as hourly, daily, or weekly. Themodule100 may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120 or a user device130 may request the output data from themodule100. In some embodiments, process600 or portions thereof may be performed on-demand, such as when a user interacts with themodule100, a clinician device130A, or a patient device130B. In this way, process600 may produce real time or substantially real time analysis. When the process600 is initiated, a set of executable program instructions stored on one or more non-transitory computer-readable media (e.g., hard drive, flash memory, removable media, etc.) may be loaded into memory (e.g., random access memory or “RAM”) of a computing device, such as a computing device of management system120. In some embodiments, the process600 or portions thereof may be implemented on multiple processors, serially or in parallel.
• At block604, the system executing the process600 may obtain one or more images of a body surface region. The image may be captured by themodule100 and provided to a user device130 and/or the management system120. For example, an image of a region of a patient's skin may be captured, such as an image of a wound or skin condition. As another example, an image of a region of a patient's mouth may be captured, such as an image of an enamel surface or oral mucosa. In some embodiments, the images may be captured on demand, such as in response to a request from a clinician device130A or patient device130B, or in response to a direct user interaction with themodule100. The images may be obtained in the form of digital image files, such as bitmap images, tag image file format (“TIFF”) images, Joint Photographic Experts Group (“JPEG”) images, or the like.
• At block606, the system executing the process600 may evaluate an image using an image analysis model or system of models, such as a machine learning model or system of such models trained to perform particular evaluations using images.FIG.7 illustrates anexample model system700 that may be used to evaluate an image. In some embodiments, as shown, themodel system700 includes aclassification model702 and a regression model704. Themodels702 and704 may be implemented as artificial neural networks. For example, theclassification model702 may be implemented as a convolutional neural network (“CNN”) trained to classify images in any number of classes, and the regression model704 may be implemented as a deep neural network (“DNN”) trained to generate scores.
• Theclassification model702 may be trained to classify an image as depicting one of a set of conditions or condition severities. For example, theclassification model702 may be trained to classify an image as depicting a wound infection, a wound of a particular volume, a lesion that is a candidate for debridement, a skin abnormality, or the like. As another example, theclassification model702 may be trained to classify an image into one of a set of severity classes, such as wound severity, degree of acne, or other body surface condition severities. The set of severity classes may include a “normal” class, a “moderate” class, and a “severe” class. The training of the model may be performed using supervised or unsupervised methods. In one specific, non-limiting embodiment, theclassification model702 may be a ResNet-152 model.
• The management system120 or an external computing system may obtain training data input including a set of labeled training images (e.g., hundreds, thousands, or more individual labeled images). Various subsets of the set of labeled training images may depict body surface regions with the various conditions and/or condition severities that the model is to be trained to detect. Additional subsets of the set of labeled training images may depict body surface regions with no such conditions. The management system120 may train theclassification model702 using the training data input, and the resulting trainedclassification model702 may be deployed for use in analyzing and classifying images. In some embodiments, the set of labeled training images may be separated into two or more subsets, including one subset used to train the model, and another subset of images not used to train the model, but rather used to test the ability of the model to accurately classify. Segmenting the training data in this way can help to avoid overfitting the model to the training data. In some embodiments, the training data may be separated into k segments, or “folds” (where k is an integer greater than two) and a cross-validation procedure such as k-fold cross-validation, may be used to train and test the model.
• In the embodiment illustrated inFIG.7, theclassification model702 includes an image input layer720 at whichimage data710 is accepted (e.g., an image file, a vector derived from the image file, or some other representation of an image to be evaluated), one or more hidden layers722 (e.g., convolutional layers, max pooling layers, fully connected layers, etc.), an embedding layer724 (e.g., a last fully-connected layer before an output layer), and a classification output layer726 (e.g., a layer of nodes at which sigmoid functions are evaluated to produce classification scores). The data generated at the embedding layer724 may be structured as a vector representation of the features generated by themodel702 from the image input data. This vector representation may serve as an image embedding730 that may be input to other models of themodel system700 for evaluation and production of output other than the classification output that theclassification model702 is trained to generate. For example, the image embedding730 may be one input to the regression model704.
• In some embodiments, evaluation of an image of a patient body surface may include a comparison of the image to a database of images of “normal” results, a database of images of specific skin/wound conditions or otherwise “concerning” results, or to individual images that have been previously classified as “normal,” indicative of specific skin or wound conditions, or otherwise “concerning.” Similarity scores or other indicia of similarity may be generated as a result of comparing an image (or set of images) of a patient body surface region to previously classified images.
• Returning toFIG.6, at block608 the system executing the process600 may generate classification output based on evaluation of the image. In some embodiments, output produced by the output layer726 of theclassification model702 may include one or more classification determinations, such as data indicating the particular class, of the classes for which themodel702 is trained to make classifications, in which the current image input data is most likely properly classified. For example, a classification determination may indicate the presence or absence of a body surface condition (e.g., a wound, a disease, etc.), or the severity of the body surface condition. As another example, the classification determination may indicate the volume or severity of a wound. As yet another example, the classification determination may indicate whether a body surface region is a candidate for debridement.
• At block610, the system executing the process600 may obtain contextual data associated with the image being analyzed. The contextual data may represent one or more contextual data items regarding the subject whose body surface region is depicted in the image being analyzed, the location of the subject, and/or various other data that can be used to evaluate the confidence of the image classification. In some embodiments, the contextual data may include, but is not limited to: sensor data from one ormore sensors102 of themodule100, demographic data regarding the subject whose body surface region is depicted in an image (e.g., age, gender), skin tone data regarding the skin tone of the subject, location data representing the geographic location of the subject, weather data regarding the weather (e.g., temperature, humidity, UV index, wind conditions, etc.) at the geographic location of the subject, treatment data representing any treatment that the subject is using on the body surface region, subject-provided data (e.g., information provided by the subject regarding their activities, subjective evaluations, etc.), other contextual data, or some combination thereof. The example contextual data items described herein are illustrative only, and are not intended to be limiting, required, or exhaustive.
• At block612, the system executing the process600 may obtain embedding data representing the image being analyzed. For example, the embedding data may be generated during evaluation of the image by theclassification model702, as described in greater detail above.
• At block614, the system executing the process600 may evaluate the embedding data and contextual data using a scoring model or system of models, such as a machine learning model or system of such models trained to perform particular evaluations using images.
• In one specific, non-limiting embodiment, the regression model704 of themodel system700 shown inFIG.7 may be trained to generate a score representative of a state of a body surface region, such as a state of health. Such a score may be referred to as a “state score” to distinguish it from other scores (e.g., scores representative of a confidence in a classification generated by the classification model702). The training of the model may be performed using supervised or unsupervised methods. For example, the management system120 or an external computing system may obtain labeled training data input including a set of image embeddings to user in a supervised training method. Each image embedding may be associated with a set of contextual data, such as the contextual data described above. Labels applied to the training data input items represent the scores to be generated for labeled training data input items by the trained model704. The management system120 may train the regression model704 using the training data input, and the resulting trained regression model704 may be deployed for use in analyzing images and additional data to generate state scores.
• In the embodiment illustrated inFIG.7, the regression model704 includes an image embedding and contextual data input layer740 at which an image embedding730 andcontextual input data732 are accepted, one or more hidden layers742, and a scoring output layer744. The scoring output layer744 may generate one or more scores, such a score in a range between a minimum and maximum value (e.g., 0-100). For example, the score may represent current state of health of a body surface region, where a higher score indicates a higher state of health. As another example, the score may represent current degree of severity of a health condition of a body surface region, where a higher score indicates a higher degree of severity.
• Returning toFIG.6, at block616 the system executing the process600 may generate scoring output based on evaluation of the image embedding and contextual data using the scoring model. For example, output produced by the output layer744 of the regression model704 may include one or more scores, as described above.
Example Process for State Change Analysis
• FIG.8 is a flow diagram of an illustrative process800 that may be executed to analyze image(s) obtained from themodule100 and determine a change in state of a body surface region over time. The process800 or portions thereof may be executed by a user device130 and/or management system120, individually or in combination. For example, process800 may be performed to analyze module output data from themodule100, such as during block410 of process400.
• The process800 begins at block802. The process800 may begin in response to an event, such as when the management system120 obtains an image captured by themodule100, when a user device130 connects to the management system120 to initiate analysis of an image (or set of images) captured by themodule100, or on a predetermined or dynamically-determined schedule. In some embodiments, process800 or portions thereof may be performed on a predetermined or dynamically-determined schedule. For example, output data from the module100 (images and/or other sensor data) may be obtained periodically, such as hourly, daily, or weekly. Themodule100 may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120 or a user device130 may request the output data from themodule100. In some embodiments, process800 or portions thereof may be performed on-demand, such as when a user interacts with themodule100, a clinician device130A, or a patient device130B. In this way, process800 may produce real time or substantially real time analysis. When the process800 is initiated, a set of executable program instructions stored on one or more non-transitory computer-readable media (e.g., hard drive, flash memory, removable media, etc.) may be loaded into memory (e.g., random access memory or “RAM”) of a computing device, such as a computing device of management system120. In some embodiments, the process800 or portions thereof may be implemented on multiple processors, serially or in parallel.
• At block804, the system executing the process800 may obtain an image of a body surface region. The image may be captured by themodule100 and provided to a user device130 and/or the management system120. For example, an image of a region of a patient's skin may be captured, such as an image of a wound or skin condition. As another example, an image of a region of a patient's mouth may be captured, such as an image of an enamel surface or oral mucosa. In some embodiments, the images may be captured on demand, such as in response to a request from a clinician device130A or patient device130B, or in response to a direct user interaction with themodule100. The images may be obtained in the form of digital image files.
• At block806, the system executing the process800 may generate an encoded version of the image, such as a hash. The encoded version may be stored for later use in comparison operations with prior or subsequent images of the same body surface region to determine whether there has been a change in the condition of the body surface region.
• In some embodiments, the encoded version may be an average hash. For example, the image may be converted to grayscale and scaled to a standard size, such as an image that is 255×255 pixels. An average of pixel values may be calculated, and individual pixels or subsets thereof may be compared to the average. If the pixels are darker than average, a particular value (e.g., 1) may be added to the hash for the pixel location, and if the pixels are lighter than average, a different value (e.g., 0) may be added to the hash for the pixel location.
• In some embodiments, the encoded version may be a distance hash. For example, the image may be converted to grayscale and scaled to a standard size. For each row, each pixel value may be compared to the value of an adjacent pixel, such as the pixel to the immediate right. If the current pixel value is darker than the value of the adjacent pixel, a particular value (e.g., 1) may be added to the hash for the pixel location, and if lighter than the adjacent pixel, a different value (e.g., 0) may be added to the hash for the pixel location.
• In some embodiments, the encoded version may be an embedding. For example, an embedding generated during the classification and scoring process and illustrated inFIG.7 may be stored for use in subsequent comparisons and other analyses.
• The example image encoding methods and formats described herein are illustrative only, and are not intended to be limiting, required, or exhaustive.
• At block808, the system executing the process800 may determine a classification and/or a score for the image. In some embodiments, the classification and/or score may be generated as described in greater detail above and illustrated inFIG.7.
• At decision block810, the system executing the process800 may determine whether a time interval for comparison has expired. If so, the process800 may proceed to block812. Otherwise, if the time interval for comparison has not expired, the process800 may terminate at block814. The time interval for comparison may be predetermined or dynamically determined. For example, the time interval may be set such that the process800 proceeds to block812 on a daily, weekly, or monthly basis.
• At block812, the system executing the process800 may determine the change in the subject's body surface region over the time interval. The change may be determined using the encoded representations of images for the current image and an image preceding the time interval, classification data generated for the respective images, scoring data generated for the respective images, other data, or some combination thereof.
• In some embodiments, encoded representations of the current image and a prior image may be compared to determine the difference between the encoded representations. For example, a Manhattan distance or a Euclidian distance between two encoded representations may be determined. Output may be generated indicating the degree to which the encoded representations differ based on the determined distances.
• In some embodiments, the scores of the current image and a prior image may be compared to determine the difference between the encoded representations. For example, the score for the current image may be subtracted from the score for a prior image, or vice versa. The difference may represent the degree to which the condition of the body surface region has changed. Illustratively, the degree may correspond to a degree of healing of a wound, a degree of improvement or deterioration of a condition, or the like.
• In some embodiments, the classifications of the current image and a prior image may be compared to determine the difference between the encoded representations. For example, each classification may be assigned a numerical value in increasing or decreasing degree of severity. The numerical value for the classification of the current image may be subtracted from the numerical value for the classification of the prior image, or vice versa. The difference may represent the degree to which the condition of the body surface region has changed. Illustratively, the degree may correspond to a degree of healing of a wound, a degree of improvement or deterioration of a condition, or the like.
• The change(s) determined at block812 may be presented to a user (e.g., via a user interface of a user device130) and/or stored for future analysis, reporting, or the like (e.g., stored on a user device130 or at the management system120).
Example of Wearable Treatment and Analysis Module for Wounds and Other Skin Conditions
• As seen inFIG.9, an illustrated embodiment of the wearable treatment andanalysis module100 includes ahousing902, acircuit board904, andonboard battery906. Thehousing902 as shown generally has an oval shape formed by alower base908 and anupper lid910. The shape and structure of the housing, however, can differ and preferably will be suited for specific applications. For example, in some embodiments, only a portion of an upper portion of thehousing902 can be removed, and in other embodiments, two or more side-by-side components can define part or all of thehousing902. Additionally, the coupling between the base908 and the lid910 (or between other components that define the housing902) can be releasable or permanent.
• In the illustrated embodiment, thelower base908 haslower surface912 with a concave shape that generally approximates a surface of the patient's body against which it will rest. Thelower surface912 preferably has a sufficient size to extend over and beyond the margins of the patient's wound that it's designed to cover. A flange or similar mounting structure (not shown inFIG.9) can extend from a lower portion of the base908 to facilitate attachment of themodule100 to the patient. For example, a flange may be mounted to or embedded within a surgical foam pad that is sized and/or shaped to cover or substantially cover a wound and, in some cases, the body surface around or adjacent to the wound. The surgical foam pad may have an aperture to provide would access to themodule100 or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.).
• With thelid910 attached to thebase908, thehousing902 defines an internal space. That space preferably is sufficiently large to house the printed circuit board904 (with all its components as described below) and to provide the field depth needed for any optical elements (e.g., camera sensor102) of themodule100. The space, however, should be minimized so as to provide thehousing902 with a slim profile and to be more form fitting. As such, themodule100 can be lighter in weight and lower in profile as it sits over the patient's wound area so as to minimize discomfort and skin irritation. The minimized profile and size also allow themodule100 to be placed within bandages, casts and the like for a wide range of wearables, including but not limited to compression bandages, negative pressure wound therapy devices, optical coherence tomography devices, and micro-elastography devices.
• While in the illustrated embodiment thehousing902 has a fixed profile, in other embodiments the profile can be increase before application or can be temporally increased during application to the patient. In one form, telescoping components of thehousing902 can provide for increased height to enlarge the field of view or coverage for one or more components of the module100 (e.g., for a camera sensor102). A user (e.g., a healthcare provider) can increase the housing's profile manually or themodule100 can include an actuating system—for example, having one or more electric or pneumatic actuators—to move the telescoping components or to move the camera sensor102 (or other components within the housing902 (e.g., the circuit board904)) relative to the patient's wound or skin.
• As illustrated inFIG.9, thelower surface912 of thehousing902 supports a series ofoptical elements914, for example, LEDs and lens(es). The LEDs can be used to illuminate the skin or wound to enhance imaging, for light therapy to help improve or heal the skin condition or wound, or both. LEDs or otheroptical elements914 that emit light to improve or heal a skin condition or wound may be configured to emit light in one or more wavelengths, such as visible light, infrared light, or other wavelengths. A controller/processor104 on thecircuit board904 controls the LEDs, and the battery powers the LEDs. Alternatively, thecircuit board904 can support the LEDs with the LEDs aligning with apertures in thebottom surface912 of thehousing902.
• Each lens of themodule100 can be auto-focusing, rotatable or otherwise movable, and/or able to zoom in or out. These features allow the user—orcontroller104 if automated—to capture images of all or substantially all of the affected area (e.g., the wound) or targeted skin area, as well as to image segments of the affected or targeted area (e.g., the wound's margins and healed boundaries). For these purposes, thecontroller104 control each lens with thebattery906 supplying power thereto. In other embodiments, the lens can be fix. Additional filters (either physical or software) can be used to enhance the images.
• Thelower surface912 of thehousing902 also can include one or more apertures. Such apertures can form part of thetreatment dispenser110 to apply a treatment agent (e.g., a therapeutic, topical fluids, ozone, etc.) to the patient's skin/wound. In some embodiments, the aperture(s) can also form part of the negative pressure wound therapy; fluids within a space between the wound and thebottom surface912 of themodule housing902 are drawn through the aperture(s) to reduce the pressure within that space.
• Moreover, as noted above, themodule100 can also or alternatively provide waveform-based treatments, such as ultraviolet light or ultrasound. Thetreatment dispenser110 for such treatments may include corresponding emission devices, such as ultraviolet light emitting diodes (as part of an array of LEDs supported by thecircuit board904 or thebottom surface912 of the housing902) and/or ultrasonic transducers. The ultrasonic transducers can extend through or be supported on thelower surface912 of themodule housing902.
• The printedcircuit board904 can be rigid but preferably is flexible, and supports and interconnects a plurality of the module's components including the controller/processor104,sensors102,data storage106, andnetwork interface108. In some embodiments, thecircuit board904 also can support and interconnect at least some components of thetreatment dispenser110 and/or thefluid treatment storage112. For example, in some embodiments, thetreatment dispenser110 can include a dispensing medicant pump or the like that draws fluid from thefluid treatment storage112 when operated by thecontroller104.
• At least some of thesensors102 are positioned on the printedcircuit board904 to correspond to the apertures and lens(es) supported by thelower surface912 of thehousing902. For example, thecamera sensor102 is located on the printedcircuit board904 such that it aligns with a lens or aperture on thelower surface912 of thehousing base908 when the printedcircuit board904 is positioned and secured in thehousing902. In some embodiments, this position lies generally at the center of thelower surface912.
• Thebattery906 supplies power to the components on the printedcircuit board904 and to the LEDs on thelower surface912 of thehousing902, and is attached to these components by one or more detachable leads. Thebattery906 preferably is rechargeable either by an external port on thehousing902 or by induction. The size of the battery preferably allows themodule100 to operate for at least one day before requiring charging, but is not too large to dramatically increase the module's profile. In some embodiments, thebattery906 can be replaced while themodule100 is attached to the patient by removing the housingupper lid910 and disconnecting and replacing thebattery906.
• In some embodiments such as the one shown inFIG.9, themodule100 also can include a digital screen displace916 (e.g., a touch screen) on the upper surface of the module, for example on theupper lid910. Indicator lights (not shown) can also or alternatively be used to provide information to the user, for example to indicate a low battery condition. Themodule100 can operate a similar UI/UX to the that used with a user device to provide controls for the module and/or to communicate data (e.g., an image of the covered wound). Themodule100 will also include a screen driver and additional processing software or firmware for this purpose. As seen inFIG.9, the module also can include an on-off button918 positioned on itsupper lid910
• While in the illustrated embodiment ofFIG.9 thebattery906 and all of the components attached to the printedcircuit board904 are located within themodule housing902, in other embodiments, such as seen inFIG.10, certain components of themodule100 can be located in aseparate device1002 that is attached to themodule100. For example, some or all of the battery, processor, data storage, network interface can be located in theseparate device1002 and attached to themodule100 by acable1004. This approach allows themodule100 to be slimmer and more form fitting; allows themodule100 to be fully enclosed/wrapped and controlled without taking off bandages; and reduces the profile and weight over the patients' wound area. Theseparate device1002 can be similarly worn by the patient at a location remote from the wound or be attached to theworn module100 when gathering data (e.g., when imaging).
• Themodule100 can be attached to the patient in a variety of ways including being fitted within bandages (including elastic compression bandages such as those used after total knee replacement and other joint replacement surgeries), wraps, and casts. For example, asFIG.9 illustrates, themodule100 can be form fit on and worn outside an associatedwrap920. Thewrap920 includes anaperture922 sized to receive at least thelower surface912 of themodule100. Interconnecting structures operate between themodule housing902 and thewrap920 to secure themodule100 to thewrap920. In some embodiments, themodule100 can be released from thewrap920, in others its permanently affixed. Thewrap920 preferably is formed of a biocompatible, breathable, skin-friendly material at least on its underside (that is, the side in contact with the patient's skin) and has a relatively largecentral portion924 to support themodule100 on the patient. In the illustrated embodiment, thewrap920 includes two pairs oflegs926,928 that extend from thecentral section924. Eachleg parings926,928 interconnects using a hook-and-loop fastener (e.g., Velcro®). That is, oneleg926,928 includes the loop portion and othercorresponding leg926,928 includes the hook portion. Eachleg pairings926,928 can be wrapped around the patient—for example, around the patient's forearm—and attached to each other. In this manner, thewrap920 secures themodule100 onto the patient's skin. Thewrap920 additionally can include an adhesive layer on its lower surface in some applications.
• By way of additional examples,FIG.11 illustrates themodule100 attached to a patient using standardadhesive coverings1102. In this example,gauze1104 is located between portions of themodule100 and patient's skin, beneath thecoverings1102.FIG.12 illustrates another example with themodule100 attached beneath or embedded within a wearable medical article such as awrap1202. In some embodiments, themodule100 can be placed on a patient and then encased in a cast (e.g., arm cast) or other protective shell. In other embodiments, the module can be sutured to the skin, although this is less preferred.
• In some embodiments, thehousing902 of themodule100 may be form, in whole or in part, from a material configured to permit wireless communication from anetwork interface108 within the housing. If thenetwork interface108 is or includes a high-speed wireless antenna, such as a 5G antenna, thehousing902 may be formed of material that does not interface, or does not substantially interfere, with communications to and/or from thenetwork interface108. For example, thehousing902 may be formed of or include any of the following materials from DuPont®: Crastin polybutylene terephthalate (PBT); Zytel HTN range of high-temperature polyamides; or Hytrel thermoplastic polyester elastomer.
Example of Wearable Treatment and Analysis Module for Wounds and Other Skin Conditions
• FIG.13A is a top plan view of another embodiment of the treatment andanalysis module100.FIG.13B is a cross-section view through themodule100 inFIG.13A. In the illustrated embodiment, themodule100 comprises ahousing1302 forming areceptacle1308. In the illustrated embodiment, an outer surface of thehousing1302 has a generally tapering oval shape. Of course, the shape of thehousing1302 is not limited to the illustrated shape and can instead have any other shape. For example, the shape and structure of thehousing1302 can differ and preferably will be suited for specific applications. While in the illustrated embodiment thehousing1302 has a fixed profile, in other embodiments disclosed herein the profile can be increase before application or can be temporally increased during application to the patient.
• In certain embodiments, themodule100 includes the network interface108 (FIG.20). Thenetwork interface108 allows themodule100 to transmit and receive data. Thenetwork interface108 can be a wired or wireless interface, such as a network adapter card and/or a wireless antenna (e.g., a Wi-Fi antenna, a Bluetooth® antenna, etc.). Similarly, the power interface109 (FIG.20) can be a wired or wireless interface, such as a receiver configured to receive power via a time-varying electromagnetic field (e.g., inductive coupling, resonant inductive coupling, capacitive coupling, magneto dynamic coupling, microwaves, and light waves, etc.) and convert the power back to an electric current. While illustrated as having a continuous outer surface inFIG.13A, in certain embodiments, thenetwork interface108 and/or thepower interface109 can include one or more connectors accessible through thehousing1302. Of course, in embodiments that wirelessly transmit and receive data and/or receive wireless power, themodule100 need not include accessible connectors accessible through thehousing1302.
• In certain embodiments, thehousing1302 comprises aflange1303. In certain embodiments, theflange1303 extends in an outward direction from a lower opening (FIG.17) into thereceptacle1308. In the illustrated embodiment, a distance theflange1303 extends away from the lower opening varies around the perimeter of the lower opening.
• In certain embodiments, a surgical foam pad may be sized and/or shaped to cover or substantially cover a wound and, in some cases, the body surface around or adjacent to the wound. The surgical foam pad may have an aperture to provide would access to themodule100 or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.). Theflange1303 may be mounted to or embedded within the surgical foam pad.
• In certain embodiments, themodule100 comprises aplatform1320. In certain embodiments, theplatform1320 is configured to be secured, directly or indirectly, to the patient. In the illustrated embodiment, theplatform1320 has a generally oval planar shape. Of course, theplatform1320 can have any shape. In the illustrated embodiment, at least a portion of theplatform1320 extends beyond an outer perimeter of theflange1303 to increase a contact area between themodule100 and the patient. In certain embodiments, a lower surface of theplatform1320 has a concave shape that generally approximates a surface of the patient's body against which it will rest. In certain embodiments, the lower surface of theplatform1320 has a sufficient size to extend over and beyond the margins of the patient's wound that it is designed to cover. In certain embodiments, theplatform1320 has a higher degree of flexibility than thehousing1302 to allow theplatform1320 to more easily bend so as to, for example, wrap about a limb or follow the curvature of a torso of the patient. In certain embodiments, a wrap or similar mounting structure (not shown inFIG.13A) attaches to theplatform1320 for facilitating attachment of themodule100 to the patient. In certain embodiments, theplatform1320 includes an adhesive for adhering themodule100 to the patient.
• In certain embodiment, thehousing1302 and theplatform1320 are manufactured as separate structures before being assembled together. In certain embodiments, thehousing1302 and theplatform1320 are assembled using an adhesive or other coupling structure known to a person having ordinary skill in the art. In certain embodiment, thehousing1302 and theplatform1320 are manufactured as a unitary structure. In certain embodiments that do not include theplatform1320, theflange1303 of thehousing1302 can instead be sized and shaped to be secured, directly or indirectly, to the patient.
• In the illustrated embodiment, theplatform1320 comprises anopening1322 aligned with the lower opening into thereceptacle1308. In this way, theplatform1320 does not block access to thereceptacle1308 when thehousing1302 is coupled to theplatform1320.
• In certain embodiments, one or more sensors/components are located in thereceptacle1308. In certain embodiments, the one or more sensors/components comprise any of the sensors/components described with respect toFIGS.1,2, and20. For example, in certain embodiments, the one or more sensors/components comprise acamera sensor1301 and abattery1306. As is explained below, in certain embodiments, thecamera sensor1301 and thebattery1306 are configured to be separately removable from thereceptacle1308 for ease of recycling.
• In the illustrated embodiment, thecamera sensor1301 is disposed on a printed circuit board (“PCB”)1304. In embodiments that include thePCB1304, thePCB1304 can be rigid but preferably is flexible, and supports and interconnects a plurality of the one or more sensors/components. For example, in certain embodiments, thePCB1304 supports not only thecamera sensor1301 but also additional sensors/components. In certain embodiments, thecamera sensor1301 is configured as a standalone device disposed in thereceptacle1308 along with thebattery1306. In certain embodiments, noPCB1304 is employed.
• In certain embodiments, themodule100 comprises acover1310. In certain embodiments, thecover1310 is sized and shaped to releasably secure in the lower opening into thereceptacle1308. When thecover1310 is attached to thehousing1302, thereceptacle1308 is defined therebetween. In certain embodiments, thereceptacle1308 is sufficiently large to house the one or more sensors/components. In embodiments that include thePCB1304 supporting the one or more sensors/components, thereceptacle1308 is sized to house the PCB1304 (with all its sensors/components). In certain embodiments, a depth of thereceptacle1308 is selected to provide the field depth needed for thecamera sensor1301 or any other optical elements (e.g., for fluorescence imaging, light therapy, etc.) of themodule100. A size of thereceptacle1308 can be minimized so as to provide thehousing1302 with a slim profile and to be more form fitting. As such, themodule100 can be lighter in weight and lower in profile as it sits over the patient's wound area so as to minimize discomfort and skin irritation. The minimized profile and size also allow themodule100 to be placed within bandages, casts and the like for a wide range of wearables, including but not limited to negative pressure wound therapy devices, optical coherence tomography devices, and micro-elastography devices.
• In certain embodiments, a film or foam dressing (e.g., surgical foam) is employed. For example, in certain embodiments, the dressing can cover the wound or area of interest on the patient. In certain embodiments, the dressing can be used to attach themodule100 to the patient. In certain embodiments, the dressing can comprise a foam with hydrophilic properties and an outer layer of hydrophobic properties with adhesive borders. For dressings that are not transparent, a hole can be cut in the dressing over the wound before attaching themodule100. In this way, the wound or area of interest on the patient is viewable by thecamera sensor1301.
• In certain embodiments, a thickness of the dressing placed between the skin of the patient and theplatform1320 is selected to achieve a desirable spacing between thehousing1302 and the skin of the patient. For example, in certain embodiments, thicker (or multiple layers) dressing can be selected to increase a distance between thehousing1302 and the skin of the patent. In this way thehousing1302 can move from a low-profile state to a raised-profile state. This adjustability can be advantageous since it changes a field of view of thecamera sensor1301. In some embodiments, a first view may be a wider-angle view than a second view due to the optical configuration of thecamera sensor1301. For example, thecamera sensor1301 may be configured to transition from the low-profile state to the raised profile state in order to zoom in on a particular subregion of the skin of the patient. In addition to or in lieu of changing a thickness of the dressing, the adjustability may be obtained by manual application of force (e.g., a user turns a zoom ring, applies pressure, etc.). In some embodiments, themodule100 and/or thecamera sensor1301 may include a motorized subsystem for transitioning from the low-profile state to the raised-profile state and vice versa. Images captured in the different states may show wide-angle and zoomed-in views, respectively. In certain embodiments, as disclosed herein, one or more structures telescope from themodule100 to transitioning themodule100 from the low-profile state to the raised-profile state and vice versa.
• FIG.14A is a left isometric view of themodule100 fromFIG.13A showing theplatform1320 of thehousing1302 configured to be secured relative to the patient.FIG.14B is a right isometric view of themodule100 fromFIG.13A. In certain embodiments such as the one shown inFIGS.14A-B, themodule100 also can include an on-off button1318. In certain embodiments, themodule100 comprises a display (not shown) and/or one ormore indicator lights1344 on an upper surface of thehousing1302. In certain embodiments, the display and/orindicator lights1344 provide information to the healthcare worker or patient, for example, to indicate a low battery condition. In certain embodiments, the flashing of the indicator light1344 can be seen through a bandage or an audio sound can be heard by the patient to inform the patient of operational status. In certain embodiments, the information can be shared with the user devices130. Themodule100 can operate a similar UI/UX to the that used with the user device130 to provide controls for the module and/or to communicate data (e.g., an image of the covered wound). Themodule100 can include a screen driver and additional processing software or firmware for this purpose.
• FIG.15A is a back isometric view of themodule100 fromFIG.13A showing anaperture1312 in thecover1310 aligned with acamera lens1324 of thecamera sensor1301.FIG.15B is a back isometric view similar toFIG.15A except thecover1310 is opaque.FIGS.16A and16B are back isometric views of themodule100 fromFIG.13A.
• As is illustrated inFIGS.15A and16A, thecamera sensor1301 is supported by thePCB1304. In the illustrated embodiment, thecamera sensor1301 is positioned on thePCB1304 to correspond to theaperture1312 in thecover1310. In this way, thecamera lens1324 has an unobstructed view of the wound or area of the patient's skin. In certain embodiments, thecover1310 need not comprise theaperture1312. For example, in certain embodiment, a portion of thecover1310 that is aligned with thecamera lens1324 is transparent allowing thecamera lens1324 to have an unobstructed view of the wound or area of the patient's skin.
• In certain embodiments, the camera module1301 (and or PCB1304) is secured within thereceptacle1308 by one ormore fasteners1334 so as to inhibit undesirable movement of thecamera sensor1301 relative to themodule100. For example, thecamera sensor1301 can be located on thePCB1304 such that thecamera sensor1301 aligns with theaperture1312 in thecover1310 when thePCB1304 is positioned and secured in thehousing1302 and thecover1310 is secured to the opening into thereceptacle1308. In some embodiments, this position lies generally at the center of thecover1310. In certain embodiments, theaperture1312 is sized so as to provide a close fit with a perimeter of thecamera sensor1301. In this way, theaperture1312 can further inhibit undesirable movement of thecamera sensor1301 relative to themodule100.
• In certain embodiments, thecover1310 comprises anouter portion1326 and aninner portion1328. In certain embodiments, theouter portion1326 has a generally planar shape. In certain embodiments, theinner portion1328 is sized and shaped to connect an inner edge of theouter portion1326 with theaperture1312. In certain embodiments, theinner portion1328 forms a recess or concave shape in the back of thehousing1302. In certain embodiments, by recessing theaperture1312 within thehousing1302, thecamera sensor1301 is supported above the patient's skin when thecover1310 is secured to the opening in thereceptacle1308. In certain embodiments, by raising thecamera lens1324 away from the patient's skin, thecamera sensor1301 achieves a desirable field of view. As explained above, themodule100 can comprises additional structures (dressing thickness and/or manual application of force) to further move or adjust thecamera sensor1301 between a low-profile state and a raised profile state.
• FIG.17 is an exploded view of themodule100 fromFIG.13A showing thePCB1304 and thebattery1306 removed from thereceptacle1308.FIG.18 is another exploded view of themodule100 fromFIG.13A showing thePCB1304 and thebattery1306 removed from thereceptacle1308. In the illustrated embodiment, thecamera sensor1301 is disposed on thePCB1304. ThePCB1304 can support one or more sensors/components including thecamera sensor1301. In certain embodiments, the one or more sensors/components comprise any of the sensors/components described with respect toFIGS.1,2 and20 (e.g., controller/processor104,sensors102,optical elements1314, led indicators1338,battery safety circuit1340,data storage106,power interface109, and/ornetwork interface108, etc.). In certain embodiments, thePCB1304 also can support and interconnect at least some components of thetreatment dispenser110 and/or thefluid treatment storage112. For example, in some embodiments, thetreatment dispenser110 can include a dispensing medicant pump or the like that draws fluid from thefluid treatment storage112 when operated by thecontroller104.
• In certain embodiments, thereceptacle1308 comprises a mounting structure for connecting to components (e.g.,PCB1304,battery1306, cover1310) of themodule100. In certain embodiments, the components secure to thehousing1302 via one or more complementary engagement structures including, for example, adhesives, fasteners, detents, projections, guide walls, recesses, or other known securement structures. For example, in certain embodiments, the back side of thereceptacle1308 comprises one ormore receptacles1330 and/or guidewalls1332. The one ormore receptacles1330 are configured to receive one ormore fasteners1334 so as to connect the components to thehousing1302. For example, in certain embodiments, afastener1334 secures thePCB1304 to thehousing1302. In certain embodiments, thebattery1306 is located between the one ormore guide walls1332 while also being sandwiched between thePCB1304 and the back wall of thereceptacle1308. In this way, once thefastener1334 securing thePCB1304 to thehousing1302 is removed, thePCB1304 and thebattery1306 are easily removed from thereceptacle1308.
• FIG.19A is a back plan view of themodule100 fromFIG.13A showing theaperture1312 in thecover1310 aligned with thecamera lens1324 of thecamera sensor1301.FIG.19B is a back plan view similar toFIG.19A except thecover1310 is opaque. In certain embodiments, a portion of thecover1310 is press fit into thehousing1302 securing thecover1310 to thehousing1302. In the illustrated embodiment, thecover1310 comprises one ormore apertures1336 for receiving the one or more fasteners1334 (not shown). In certain embodiments, once the one ormore fasteners1334 are disengaged from the one ormore receptacles1330, thecover1310 can be removed to then lift out components from thereceptacle1308, separate, and separately recycled without further disassembly. For example, in certain embodiments, a healthcare provider at a hospital can place the disassembled components in their recycling program since, for example, thebattery1306 and other components meet requirements for disposal in a landfill. In other embodiments, themodule100 is reusable. For example, thereusable module100 can be configured for removal and replacement of thebattery1306 along with the healthcare provider being able to change an electronic identifier of themodule100 for the new patient.
• FIG.20 is a schematic view of themodule100 fromFIG.13A. The treatment andanalysis module100 may include one ormore sensors102 to monitor and generate data regarding user skin characteristics. In certain embodiments, the one ormore sensors102 may include a visualization element, such as thecamera sensor1301, to capture images and/or generate other visualization data regarding the skin of the user. Such visualization data may be used to monitor a wound or other skin aspect over time, to diagnose a skin condition, to determine a treatment for a skin condition, and/or to monitor the treatment of a skin condition over time. In certain embodiments, the one ormore sensors102 may also or alternatively include a temperature sensor to determine the temperature of the user's body surface region and/or the ambient temperature. In certain embodiments, the one ormore sensors102 may also or alternatively include an accelerometer to assess movements and activities of the patient. In certain embodiments, the one ormore sensors102 may also or alternatively include a pH sensor to determine the pH level of the user's body surface region. In some embodiments, the one ormore sensors102 may also or alternatively include a moisture sensor to determine the moisture content of the user's body surface region and/or the ambient moisture around a location of the user's body surface region. Theexample sensors102 described herein are illustrative only, and are not intended to be limiting, required, or exhaustive of thesensors102 that may be included in a treatment andanalysis module100.
• The treatment andanalysis module100 may include the processor/controller104, such as a system on a chip (“SOC”) or other microprocessor to process data and commands. In some embodiments, theprocessor104 may process data from the one ormore sensors102 and/or adata store106, execute one or more analysis or detection algorithms, receive and execute commands from other devices via thenetwork interface108, or the like. In some embodiments, thedata store106 may be a substantially persistent data store, such as flash memory, hard disk, or the like.
• Thenetwork interface108 may be a wired or wireless network interface, such as a network adapter card and/or a wireless antenna (e.g., a Wi-Fi antenna, a Bluetooth® antenna, etc.). For example, thenetwork interface108 can utilize RF, infrared or other wireless circuitry (receiver or transmitter, or transceiver) to communicate with a remote device. In certain embodiments, thenetwork interface108 is implemented as a Wi-Fi module and/or a cellular module. In certain embodiments, thenetwork interface108 comprises an antenna.
• In the illustrated embodiment, thenetwork interface108 is on thesame PCB1304 as other electronics and located within thehousing1302. In certain embodiments, the Wi-Fi module connects the components of thePCB1304 to a LAN via a Wi-Fi connection. In certain embodiments,multiple modules100 withmultiple network interfaces108 connect to a single LAN.
• In certain embodiments, thenetwork interface108 comprises a cellular module. In certain embodiments, the cellular module communicates to the Internet via a mobile carrier's network. Depending on the location and carrier, various standards, such as GPRS, GSM, and CDMA, and the like may apply.
• In certain embodiments, a lower surface of the module100 (e.g., cover1310) supports a series ofoptical elements1314, for example, LEDs and lasers. Theoptical elements1314 can be used to illuminate the skin or wound to enhance imaging, for light therapy to help improve or heal the skin condition or wound, or both. In certain embodiments, theoptical elements1314 provide waveform-based treatments, such as ultraviolet light or ultrasound. In certain embodiments, theoptical elements1314 emit UV light (e.g., UVA (315-400 nm), UVB (280-315 nm), and/or UVC (200-280 nm)). Exemplary indications of use for light therapy include using ultraviolet light to treat disorders of the skin (e.g., psoriasis, acne vulgaris, eczema and neonatal jaundice, etc.). For example, theoptical elements1314 can emit UVC to kill pathogens without unacceptable damage to host tissue of the patient. UVB can stimulate wound healing. UV sources can include light-emitting diodes, lasers, and microwave-generated UV plasma. In certain embodiments, theoptical elements1314 emit low level laser therapy for treatment of the wound. In certain embodiments, microwave-generated ultraviolet plasma may be used therapeutically.
• In certain embodiments, theoptical elements1314 are configured for fluorescence imaging (e.g., near-infrared fluorescence imaging). In certain embodiments, data obtained from fluorescence imaging visualizes bacteria to assist wound treatment by the healthcare provider. For example, theoptical elements1314 can detect bacterial loads and location with respect to the wound. The bacterial loads can be used by the physician to assess or reassess clinical treatment of the wound.
• In certain embodiments, the processor/controller104 on thePCB1304 can control theoptical elements1314 while thebattery1306 powers theoptical elements1314. Alternatively, thePCB1304 can support theoptical elements1314 with theoptical elements1314 aligned with apertures in thecover1310 of thehousing1302 or employ atransparent cover1310 without the need for apertures.
• In certain embodiments, thebattery1306 supplies power to the one or more sensors/components of themodule100. In certain embodiments, thebattery1306 attaches to the components by one or more detachable leads. Thebattery1306 can be rechargeable either by an external port on thehousing1302 or by inductive charging (i.e., wireless) as explained above. In certain embodiments, thebattery1306 is a rechargeable lithium ion battery with a voltage of3.7. Of course, the type and capacity of thebattery1306 are not limited to the listed type and value and instead can be any other type ofbattery1306 having any other capacity or value. In certain embodiments, thebattery1306 is about 4.5 mm thick, 52.5 mm long, and 20.7 mm wide. The dimensions of thebattery1306 can be selected to be similar to the dimensions of the PCB1304 (e.g.,PCB1304—4.87 mm thick, 52.33 mm long, and 21.05 mm wide) for theexemplary battery1306 dimensions provided above. The size of thebattery1306 can be selected to allow themodule100 to operate for at least one day before requiring charging. In certain embodiments, thebattery1306 can be recharged while themodule100 is attached to the patient wirelessly or via a wired connection.
• In certain embodiments, themodule100 includes abattery safety circuit1340. For example, in certain embodiments, thebattery safety circuit1340 is configured so that themodule100 complies with International Electrotechnical Commission (“IEC”) 62133 (Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications). In this way, the dimensions of thebattery1306 and its re-chargeable characteristics comply with the standard. In certain embodiments, thebattery safety circuit1340 allows safe inductive charging of thebattery1306. In certain embodiments, thebattery safety circuit1340 is incorporated on thePCB1304.
• In certain embodiments, themodule100 includes thecamera lens1324. In certain embodiments, thecamera lens1324 can be auto-focusing, rotatable or otherwise movable, and/or able to zoom in or out. In certain embodiments, themodule100 includes a manual slide control for angle and viewing. In certain embodiments, the manual slide control is located on a side of thehousing1302 to allow the healthcare provider to adjust thelens1324 to cover the best viewing distance and angle. In certain embodiments, themodule100 includes a motor slide control for angle and viewing. In certain embodiments, the motor slide control can be controlled remotely. These features allow the user (orcontroller104 if automated) to capture images of all or substantially all of the affected area (e.g., the wound) or targeted skin area, as well as to image segments of the affected or targeted area (e.g., the wound's margins and healed boundaries). For these purposes, the processor/controller104 can control thecamera lens1324 with thebattery1306 supplying power thereto. In other embodiments, thelens1324 can be fix. Additional filters (either physical or software) can be used to enhance the images.
• In certain embodiments, themodule100 includes thetreatment dispenser110 and/or thefluid treatment storage112. For example, in some embodiments, thetreatment dispenser110 can include a dispensing medicant pump or the like that draws fluid from thefluid treatment storage112 when operated by theprocessor104. A lower surface of themodule100 can include one or more apertures. Such apertures can form part of thetreatment dispenser110 to apply a treatment agent (e.g., a therapeutic, topical fluids, ozone, etc.) to the patient's skin/wound.
• In certain embodiments, the aperture(s) can also form part of a negative pressurewound therapy module1342. For example, in certain embodiments, the negative pressurewound therapy module1342 can draw fluids from within a space between the wound and the lower surface of themodule100 to reduce the pressure within that space. In certain embodiments, the negative pressurewound therapy module1342 comprises the space (e.g., a fluid collection container) and a vacuum pump. One or more tubes can channel fluid between the wound dressing, the fluid collection container, and the vacuum pump.
• FIG.21A is a plan top view of an exemplary embodiment of the PCB1304 (e.g., including camera sensor1301) fromFIG.13A.FIG.21B is a back side view of thePCB1304 fromFIG.21A.FIGS.21A-B illustrate certain of the one or more sensors/components of themodule100 but are not intended to limit the number of components that can be carried by thePCB1304 to those illustrated. One or more of any of the components disclosed herein can be carried by the PCB1304 (or multiple PCBs1304) and/ormodule100.
• In certain embodiments, thePCB1304 comprises anantenna1348. In certain embodiments, theantenna1348 is configured as a planar inverted-F antenna (PIFA). In certain embodiments, thenetwork interface108 of thePCB1304 comprises a wireless chip. In certain embodiments, the wireless chip is configured as a Wi-Fi and/or Bluetooth chip. In certain embodiments, thenetwork interface108 of thePCB1304 comprises a port for data transmission. In certain embodiments, the port is configured as a serial peripheral interface (SPI) port. In certain embodiments, theantenna1348 and the port are employed by thenetwork interface108 to receive and send data by themodule100. Thenetwork interface108 may be a wired or wireless network interface, such as a network adapter card and/or a wireless antenna (e.g., a Wi-Fi antenna, a Bluetooth® antenna, etc.).
• In certain embodiments, thePCB1304 comprises one ormore buttons1346 for controlling/programming the components disposed on thePCB1304. In certain embodiments, thePCB1304 comprises one ormore LED indicators1344.
• In certain embodiments, thepower interface109 can be a wired or wireless interface, such as a receiver configured to receive power via a time-varying electromagnetic field (e.g., inductive coupling, resonant inductive coupling, capacitive coupling, magneto dynamic coupling, microwaves, and light waves, etc.) and convert the power back to an electric current. In the illustrated embodiment, thepower interface109 is configured as a USB port. Of course, thepower interface109 need not be configured as a USB port and instead can be configured as any other type of port for receiving power. In certain embodiments, thepower interface109 supplies power to all of the components of thePCB1304. In certain embodiments, thedata store106 may be a substantially persistent data store, such as flash memory, hard disk, or the like.
• FIG.22A is a perspective view of thePCB1304 fromFIG.13A.FIG.22B is a front plan view of thePCB1304 fromFIG.22A.FIG.22C is a side view of thePCB1304 fromFIG.22B.FIG.22D is an upper plan view of thePCB1304 fromFIG.22A. The dimensions disclosed inFIGS.22A-D are only exemplary and are not intended to limit the size of thePCB1304 in any way. As explained above, in certain embodiments, the dimensions of thebattery1306 can be selected to be similar to the dimensions of the PCB1304 (e.g.,PCB1304—4.87 mm thick, 52.33 mm long, and 21.05 mm wide) for theexemplary battery1306 dimensions provided above.
• FIG.23A is a top plan view of another embodiment of the treatment andanalysis module100 that is similar to themodule100 ofFIG.13A except thehousing1402 comprises one ormore legs1404 which telescope from thehousing1402. In certain embodiments, the one ormore legs1404 are movable between extended and retracted configurations. In certain embodiments, the one ormore legs1404 are fixed in the extended configuration.
• In certain embodiments, the one ormore legs1404 can extend from themodule100 at a location above or below theplatform1320. For example, the one ormore legs1404 inFIGS.23A to26B extend from thehousing1402 at a location that is above theplatform1320 while the one ormore legs1404 inFIGS.27A to29B extend from thehousing1502 at a location that is below theplatform1320. In certain embodiments that includemultiple legs1404, themultiple legs1404 can be internally linked so that themultiple legs1404 move in unison when any one of thelegs1404 is moved between the extended and retracted configurations.
• When in the extended configuration, themodule100 can be placed over larger wound areas than when the one ormore legs1404 are in the retracted configuration. In certain embodiments, the one ormore legs1404 allow for themodule100 to be centered or placed in any location on the patient with the one ormore legs1404 extending beyond an outer perimeter of theplatform1320. In certain embodiments, the one ormore legs1404 extend to a dressing encircling the wound. In certain embodiments, the one ormore legs1404 are affixed in place by, for example, surgical/medical tape, or a foam riser that is affixed to the skin of the patient.
• In certain embodiments, a surgical foam pad may be sized and/or shaped to cover or substantially cover a wound and, in some cases, the body surface around or adjacent to the wound. The surgical foam pad may have an aperture to provide would access to themodule100 or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.). One ormore legs1404 may extend to maintain themodule100 at a height above the body surface and/or to be embedded within the surgical foam pad.
• In certain embodiments, the one ormore legs1404 provide for increased height to enlarge the field of view or coverage for one or more components of the module100 (e.g., for the camera sensor1301). In this way, the user (e.g., a healthcare provider) can increase the housing's profile manually by extending the one ormore legs1404. In certain embodiments, themodule100 can include an actuating system (e.g., one or more electric or pneumatic actuators) to extend the one ormore legs1404 or to move the camera sensor1301 (or other components within the housing1402 (e.g., the PCB1304)) relative to the patient's wound or skin.
• The one ormore legs1404 inFIG.23A are in the extended configuration. The illustrated embodiment comprises fourlegs1404. However, themodule100 can comprise more orfewer legs1404 than is illustrated inFIG.23A.FIG.23B is a cross-section view through themodule100 inFIG.23A showing the one ormore legs1404 in the extended configuration. In the illustrated embodiment, eachleg1404 comprises arod1406 having adistal end1408. In certain embodiments, therod1406 and thedistal end1408 comprise different materials. For example, in certain embodiments, therod1406 comprises stainless steel while thedistal end1408 is an over molded plastic to therod1406. Of course the material of therod1406 need not be stainless steel and instead can be any other material.
• As is illustrated inFIG.23A, anouter portion1412 of thedistal end1408 can have a generally U-shape as viewed inFIG.23A. As also illustrated inFIG.23A, aninner portion1414 of thedistal end1408 can have a surface that matches apad1416 on an outer surface of thehousing1402. In certain embodiments, theinner portion1414 contacts thepad1416 when theleg1404 is in the retracted configuration. Of course the shapes of theinner portion1414 andpad1416 are not limited to the illustrated shapes.
• FIG.24A is a top plan view of themodule100 fromFIG.23A showing the one ormore legs1404 in the extended configuration.FIG.24B is a top plan view similar toFIG.24A except the one ormore legs1404 are in the retracted configuration.FIG.25A is a back plan view of themodule100 fromFIG.23A showing the one ormore legs1404 extending beyond an outer perimeter of theplatform1320 when in the extended configuration.FIG.25B is a back plan view similar toFIG.25A except the one ormore legs1404 are in the retracted configuration hidden behind theplatform1320. In certain embodiments, thedistal end1408 is sized larger than therod1406. In this way, thedistal end1408 comprises acontact surface1410 that has a width greater than a width of therod1406. In certain embodiments, thecontact surface1410 provides sufficient stability to themodule100 when thecontact surface1410 is secured relative to the patient.
• FIG.26A is a left isometric view of themodule100 fromFIG.23A showing the one ormore legs1404 in the extended configuration.FIG.26B is a right isometric view of themodule100 fromFIG.23A showing the one ormore legs1404 in the extended configuration.
• FIG.27A is a top plan view of another embodiment of the treatment andanalysis module100 that is similar to themodule100 ofFIG.23A except the one ormore legs1404 extend from thehousing1502 at a location below theplatform1320. In the illustrated embodiment, the one ormore legs1404 extend from thecover1510.FIG.27B is a cross-section view through themodule100 inFIG.27A showing the one ormore legs1404 in the extended configuration.
• In certain embodiments, the one ormore legs1404 are movable between extended and retracted configurations. In certain embodiments that includemultiple legs1404, themultiple legs1404 can be internally linked so that themultiple legs1404 move in unison when any one of thelegs1404 is moved between the extended and retracted configurations.
• FIG.28A is a back plan view of themodule100 fromFIG.27A showing the one ormore legs1404 extending from thecover1510 and in the extended configuration.FIG.28B is a back plan view similar toFIG.28A except the one ormore legs1404 are in the retracted configuration. In certain embodiments, the one ormore legs1404 provide for increased height to enlarge the field of view or coverage for one or more components of the module100 (e.g., for the camera sensor1301). In this way, the user (e.g., a healthcare provider) can increase the housing's profile manually by extending the one ormore legs1404. In certain embodiments, themodule100 can include an actuating system (e.g., one or more electric or pneumatic actuators) to extend the one ormore legs1404 or to move the camera sensor1301 (or other components within the housing1302 (e.g., the PCB1304)) relative to the patient's wound or skin.
• The illustrated embodiment comprises fourlegs1404. However, thehousing1510 can comprise more orfewer legs1404 than is illustrated inFIG.28A. In the illustrated embodiment, eachleg1404 comprises arod1406 having adistal end1408. In certain embodiments, therod1406 and thedistal end1408 comprise different materials. For example, in certain embodiments, therod1406 comprises stainless steel while thedistal end1408 is over molded plastic to therod1406. Of course the material of therod1406 need not be stainless steel and instead can be any other material.
• As is illustrated inFIG.28A, anouter portion1412 of thedistal end1408 can have a general arc shape as viewed inFIG.28A. As also illustrated inFIG.28A, thecover1510 can comprise achannel1512 sized and shaped to receive thedistal end1408 when the one ormore legs1404 are in the retracted configuration. In certain embodiments, thedistal end1408 is sized and shaped to match thechannel1512 in thecover1510. Of course the shapes of thedistal end1408 and thechannel1512 are not limited to the illustrated shapes.
• FIG.29A is a left isometric view of themodule100 fromFIG.27A showing the one ormore legs1404 in the extended configuration.FIG.29B is a right isometric view of themodule100 fromFIG.27A showing the one ormore legs1404 in the extended configuration. In certain embodiments, thedistal end1408 is sized larger than therod1406. In this way, thedistal end1408 comprises acontact surface1410 that has a width greater than a width of therod1406. In certain embodiments, thecontact surface1410 provides stability to themodule100 when thecontact surface1410 is secured relative to the patient.
• In some embodiments, one ormore legs1404 may be integrated with a bracket (not shown) that is placed over or near the body tissue region of interest. In this configuration, the one ormore legs1404 may provide vertical height adjustment for aseparate module100 that is coupled to (e.g., securely snapped into place on) the bracket. Fixed-length or adjustable-length horizontal supports may extend from the bracket to facilitate securement of the bracket to a wearable medical article (e.g., medical foam) that surrounds or is near the body surface region of interest.
• Although some examples and embodiments described herein relate to use of amodule100 with a wearable medical article, the examples are illustrative only and are not intended to be limiting. In some embodiments, themodule100 may be used during a procedure to help surgeons and/or robotic operators carry out delicate maneuvers and avert damage to adjacent tissues and organs. The module can provide intra-operative imaging and/or other sensor data for intelligent instrumentation that facilitates real-time surgical navigation of critical structures. In orthopedics, surgeons may experience reduced complexity, reduced operating room time, increased operating room turnover, all within a footprint that is designed to serve both ambulatory surgical centers and specialty hospital settings.
• The materials used in the embodiments disclosed herein can be any suitable types of materials. For example, the materials can be selected such that the module materials are suitable for repeated exposures to body and treatment fluids. The module materials can be suitable for repeated exposure to autoclave or other clinically utilized sterilization processes. In some of the disclosed embodiments, replaceable components of the module can be suitable for one-time exposure to body and treatment fluids. Those materials can be suitable for exposure to gamma sterilization or any other suitable sterilization process.
Terminology
• Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described operations, sequencing, or events are necessary for the practice of the algorithm). Moreover, in certain embodiments, operations or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.
• The various illustrative logical blocks, modules, routines, and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware, or combinations of electronic hardware and computer software. To clearly illustrate this interchangeability, various illustrative components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware, or as software that runs on hardware, depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure.
• Moreover, the various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a computer processor device, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A computer processor device can be a microprocessor, but in the alternative, the processor device can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor device can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor device includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor device can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor device may also include primarily analog components. For example, some or all of the algorithms described herein may be implemented in analog circuitry or mixed analog and digital circuitry. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.
• The elements of a method, process, routine, or algorithm described in connection with the embodiments disclosed herein can be embodied directly in hardware, in a software module executed by a processor device, or in a combination of the two. A software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of a non-transitory computer-readable storage medium. An exemplary storage medium can be coupled to the processor device such that the processor device can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor device. The processor device and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal. In the alternative, the processor device and the storage medium can reside as discrete components in a user terminal.
• Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
• Disjunctive language such as the phrase “at least one of X, Y, Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and/or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.
• Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.
• While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it can be understood that various omissions, substitutions, and changes in the form and details of the devices or algorithms illustrated can be made without departing from the spirit of the disclosure. As can be recognized, certain embodiments described herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others.
• Reference throughout this specification to “some embodiments” or “an embodiment” means that a particular feature, structure, element, act, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in some embodiments” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment and may refer to one or more of the same or different embodiments. Furthermore, the particular features, structures, elements, acts, or characteristics may be combined in any suitable manner (including differently than shown or described) in other embodiments. Further, in various embodiments, features, structures, elements, acts, or characteristics can be combined, merged, rearranged, reordered, or left out altogether. Thus, no single feature, structure, element, act, or characteristic or group of features, structures, elements, acts, or characteristics is necessary or required for each embodiment. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure.
• Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Rather, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
• The foregoing description sets forth various example embodiments and other illustrative, but non-limiting, embodiments of the inventions disclosed herein. The description provides details regarding combinations, modes, and uses of the disclosed inventions. Other variations, combinations, modifications, equivalents, modes, uses, implementations, and/or applications of the disclosed features and aspects of the embodiments are also within the scope of this disclosure, including those that become apparent to those of skill in the art upon reading this specification. Additionally, certain objects and advantages of the inventions are described herein. It is to be understood that not necessarily all such objects or advantages may be achieved in any particular embodiment. Thus, for example, those skilled in the art will recognize that the inventions may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. Also, in any method or process disclosed herein, the acts or operations making up the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence.

Claims (20)

The following is claimed:

1. A system comprising:

a wearable medical article;

a module configured to be mounted to the wearable medical article, wherein the module comprises:

one or more sensors configured to generate sensor data regarding a body surface region of a wearer of the wearable medical article;

a treatment dispenser configured to administer a treatment to the body surface region; and

a wireless network interface configured to transmit the sensor data; and

a computing system comprising one or more computer processors and executable instructions, wherein the computing system is configured to:

receive the sensor data;

receive contextual data associated with the wearer; and

evaluate the sensor data and contextual data using a machine learning model to generate a score representing a current state of the body surface region.

2. The system ofclaim 1, wherein a sensor of the one or more sensors comprises: a camera sensor, a temperature sensor, a moisture sensor, a pH sensor, or a pressure sensor.

3. The system ofclaim 1, wherein the computing system is further configured to train the machine learning model using training data comprising training sensor data and training contextual data, wherein the training data is associated with one or more body surface region classifications to be generated by the machine learning model.

4. The system ofclaim 1, wherein the computing system is further configured to train the machine learning model using training data comprising training sensor data and training contextual data, wherein the training data is associated with one or more state scores to be generated by the machine learning model.

5. The system ofclaim 1, wherein the module is configured to transition from a first low-profile state to a second raised-profile state.

6. The system ofclaim 1, wherein the computing system is further configured to generate output data based at least partly on the score, wherein the output data represents at least one of: a treatment instruction, a sensor instruction, or a body surface region classification.

7. The system ofclaim 6, wherein the computing system is further configured to transmit the output data to at least one of: the module, or a computing device in communication with the module.

8. A system comprising:

a wearable medical article;

a module configured to be mounted to the wearable medical article, wherein the module comprises:

one or more sensors configured to generate sensor data regarding a body surface region of a wearer of the wearable medical article; and

a wireless network interface configured to transmit the sensor data; and

a computing system comprising one or more computer processors and executable instructions, wherein the computing system is configured to:

receive the sensor data;

receive contextual data associated with the wearer; and

evaluate the sensor data and contextual data using a machine learning model to generate a score representing a current state of the body surface region.

9. A wearable medical module for placement over a wound, comprising:

a housing forming a receptacle having a lower opening configured to face the wound;

a camera sensor and battery sized and shaped to be disposed in the receptacle; and

a cover disposed over the lower opening and having an aperture aligned with the camera sensor so that the camera sensor has a field of view of the wound through the aperture.

10. The module ofclaim 9, further comprising a PCB supporting the camera sensor.

11. The module ofclaim 9, wherein the battery is configured to be wirelessly charged.

12. The module ofclaim 9, further comprising one or more optical element configured to apply light therapy to the wound.

13. The module ofclaim 9, further comprising one or more optical element configured for fluorescence imaging.

14. The module ofclaim 9, wherein the module is configured to transition from a first low-profile state to a second raised-profile state.

15. The module ofclaim 9, further comprising one or more legs configured to move between retracted and extended configurations.

16. The module ofclaim 15, wherein the one or more legs extend from a lower surface of the module.

17. The module ofclaim 15, wherein the one or more legs extend from an upper surface of the module.

18. The module ofclaim 9, further comprising a battery safety circuit configured to monitor wireless charging of the battery.

19. The module ofclaim 9, further comprising a negative pressure wound therapy module configured to draw fluids from within a space between the wound and a lower surface of the module to reduce pressure within the space.

20. The module ofclaim 9, further comprising a platform coupled to the housing and being configured to be secured relative to the wound.

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