Patent ID: 12254989

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.1shows a network environment including a treatment and analysis 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 network140may 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 and analysis module100may be, or be part of, a personal care system. The treatment and analysis module100may 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 system120and/or user devices130.

The treatment and analysis module100may include one or more sensors102to monitor and generate data regarding user skin characteristics. In some embodiments, the one or more sensors102may 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 or more sensors102may 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 or more sensors102may also or alternatively include an accelerometer to assess movements and activities of the patient. In some embodiments, the one or more sensors102may also or alternatively include a pH sensor to determine the pH level of the user's body surface region. In some embodiments, the one or more sensors102may 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 or more sensors102may 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 and analysis module100is mounted. The example sensors102described herein are illustrative only, and are not intended to be limiting, required, or exhaustive of the sensors102that may be included in a treatment and analysis module100. In some embodiments, one treatment and analysis module100may be configured for use with a particular type of suture site or other wound, and may include a particular set of one or more sensors102that 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 and analysis module100may include a processor104, such as a system on a chip (“SOC”) or other microprocessor to process data and commands. In some embodiments, the processor104may process data from one or more sensors102and/or the data store106, execute one or more analysis or detection algorithms, receive and execute commands from other devices via a network interface108, or the like. In some embodiments, the data store106may be a substantially persistent data store, such as flash memory, hard disk, or the like. The network interface108may 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 and analysis module100may 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 a fluid treatment storage112, and dispensation of the fluid treatment may be performed using a treatment dispenser110. In some embodiments, the fluid treatment storage112may be a fluid-tight container in fluid communication with the treatment dispenser110. The treatment dispenser110may include an aperture through which fluid from the fluid treatment storage112can be dispensed onto a body surface region of a user. In some embodiments, the treatment dispenser110may 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. The treatment dispenser110for such treatments may include corresponding emission devices, such as ultraviolet light emitting diodes (“LEDs”) and/or ultrasonic transducers.

In some embodiments, the treatment and analysis module100may 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 and analysis module100instead 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 and analysis module100may 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/or network interface108may be integrated into or coupled to a circuit board. In this configuration, the circuit board assembly and other components of the module100may 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 and analysis module100may be a removable component of a personal wound care device, such as a bandage or cast. The treatment and analysis module100may 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 and analysis module100is 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 and analysis module100may 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 and analysis module100is to be placed. In some embodiments, a treatment and analysis module100may be sized, shaped, or otherwise configured for robotic placement. For example, a treatment and analysis module100may 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 and analysis module100or 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 and analysis module100come into physical content with a region of a user's body surface (e.g., a wound, dental enamel, or oral mucosa), the treatment and analysis module100as a whole may be limited use. As another example, components of the portions of the treatment and analysis module100that 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 and analysis module100, such as the fluid treatment storage112, may include exhaustible resources. Such portions may be refillable or replaceable. Examples and details of limited-use treatment and analysis modules100or components thereof are shown inFIG.2and described in greater detail below.

The management system120may include various components for providing the features described herein. Illustratively, the management system120may include an analysis component122to process data received from the treatment and analysis module100(e.g., sensor data, treatment data, etc.), determine treatment instructions, and the like. The management system120may also include a portal server124that 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 system120may also include a data store126that maintains data regarding treatments, results, users, and the like. The example components and data stores of the management system120shown inFIG.1are illustrative only, and are not intended to be limiting, required, or exhaustive. In some embodiments, a management system120may have fewer, additional, and/or alternative components and data stores.

The management system120may be implemented on one or more physical server computing devices that provide computing services and resources to treatment and analysis modules100and 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 system120may include any number of such hosts.

In some embodiments, the features and services provided by the management system120may 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 devices130may 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 device130may be used to access data generated by a treatment and analysis module100or management system120, to provide data and/or instructions to a treatment and analysis module100or management system120, etc.

The treatment and analysis 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 device130to interact with the treatment and analysis 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 device130to interact with the treatment and analysis module100and/or the management system120. In some embodiments, application software to interact with the treatment and analysis module100and/or management system120may be provided to the user device130over 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 and analysis module100may include an application programming interface (“API”). The API can be implemented within or called by the user device130using the software application. It will be appreciated that the module100, user device130, and/or management system120may communicate with each other via the network140using 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 device130may implement aspects of the API related to generating user interfaces that display images captured by the module100, while a management system120may implement aspects of the API that employ one or more machine learning models to analyze images provided to the management system120by the module100or 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 device130may 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 the module100, management system120, or user device130can provide any or all of following functionalities: power on or off the module100; take before and after images via a camera sensor of the module100; instruct the user through the user device130on 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 the module100; 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 the module100; and/or provide detailed images to the management system120or another user device130for evaluation.

The management system120and/or user device130can process images from a camera of the module100. In some arrangements, an API can be used for capturing an image with a camera sensor102. The camera sensor102can 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 device130can allow a user to program or control the operation of the module100via an API. The module100can 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, the module100includes a camera sensor with zoom-in functionality that increases the magnification of the camera.

In some embodiments, the module100includes 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, the module100includes 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.

The module100may generate digital photographs that one or more user devices130or the management system120can 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 a data store106of the module100or a data store126of 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 the module100or a health care professional can cause the module100to take a “before” image before treating a body surface region, then cause dispensation of treatment to the body surface region via the treatment dispenser110, and then cause the module to take an “after” image of the body surface region. In this way, the module100and remote access to images captured by the module100can 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 the module100to 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, the module100can 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 and analysis module100will be described. In some embodiments, as shown, a portion of the treatment and analysis module100can be implemented as a limited use component202. For example, the limited use component202may 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 and analysis module100, such as one or more of the sensors102or a treatment 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 component202may be or include a reservoir for an exhaustible resource, such as a fluid 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 component202can be replaced with a new component202that has a fresh supply of the exhaustible resource.

The limited use component202may be removably attached to a reusable substrate for use. In some embodiments, the treatment and analysis module100may include a reusable component200to which the limited use component202may be removably attached. The reusable component may include additional components of the treatment and analysis module100that are not included in the limited use component202or 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 and analysis module100, such as the processor104, data store106, and network interface108. One or more sensors102may 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 or more sensors102that 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 component202due 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 component202may include a protected exposure portion, such as a sealed window or filtered aperture, through which the sensor of the reusable component200may gain exposure to a body surface region of the user.

In certain arrangements, the reusable component200or the treatment and analysis module100as a whole can be waterproof or water-resistant, allowing the reusable component200or module100to be submerged or brought into contact with water without damage. For example, the module100can be adapted to allow a user to use the module100in a shower or a bathtub. The housing of the module100can form a water-tight seal that prevents water from entering the internal space of the module100, thereby protecting the internal electronics of the module100from being contacted by water. The housing of the module100can form a water-tight seal with the personal care device to which the module is attached.

FIG.3illustrates a treatment and analysis module100with 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 region300is obtained, showing surface portions of interest302and304. 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 of interest302. 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, the module100and/or the camera sensor102may 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.4is a flow diagram of an illustrative process400that may be executed to use and/or manage the operation of a treatment and analysis module100. The process400or portions thereof may be executed by a user device130and/or management system120, individually or in combination. Advantageously, execution of the process400allows for remote access to data generated by a treatment and analysis module100, and remote control of operations of the treatment and analysis module100. For example, the process400allows for implementation and analysis of a monitoring regimen in which sensor data is generated for analysis. As another example, the process400allows for implementation of a treatment regimen in which a treatment is administered to a wearer of the module100. The wearer of the module100may also be referred to as a “subject” of the sensor data generated by and/or treatment administered by the module100.

Portions of the process400will be described with further reference to the illustrative data flows and interactions between the treatment and analysis module100, management system120, clinician user device130A, and patient user device130B shown inFIG.5.

The process400begins at block402. The process400may begin in response to an event, such as when a clinician device130A connects to the management system120to initiate a regimen for use of the treatment and analysis module100. In some embodiments, process400or 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. The module100may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120or a user device130may request the output data from the module100. In some embodiments, process400or portions thereof may be performed on-demand, such as when a user interacts with the module100, a clinician device130A, or a patient device130B. In this way, process400may produce real time or substantially real time implementation and analysis. When the process400is 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 process400or portions thereof may be implemented on multiple processors, serially or in parallel.

At block404, the system executing the process400may determine a regimen for use of the module100. In one embodiment, a regimen may specify a treatment to be administered by the module100. For example, the module100may 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 system120or 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 the module100or 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 process400may send regimen instructions to the module100. 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.5illustrates an example in which a clinician device130A generates and transmits regimen instructions to the management system120at [1]. The management system120then provides the regimen instructions to the treatment and analysis module100. As shown, the treatment and analysis module100may be positioned on a subject via a module mount500, such as a bandage, cast, strap, or other wearable medical article to which the module100is coupled. For example, the mount500may be worn such that the module100, 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 device130may 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 the module100itself, 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 system120may maintain communication data that specifies where or how communications are to be sent to the module100identified 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 the module100or patient device130B. Using this communication data, the management system120may transmit the regimen instructions. Instructions may be transmitted directly to the module100if 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 the module100, such as the patient device130B, indicated as [1′]. A communication path between the patient device130B and module100can be established to provide the regimen instructions, or data derived therefrom, to the module100.

Returning toFIG.4, at block408the system executing the process400may obtain data from the module100. The data may include sensor data, data regarding a treatment administered by the module100, 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 the module100, 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 system120or 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 the module100. The request may be sent to the management system120, which may provide the request to the module100directly or via an intermediary such as the patient device130B, in a manner similar to that described with respect to providing regimen instructions. The module100may generate, access, or otherwise obtain the requested data and provide it to the requesting device. For example, as shown inFIG.5, the module100may 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 process400may 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 system120via 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 and analysis module100is first configured for the patient, or when data is received for analysis. The management system120may select, based on the specified surgery or wound type, a model or set of models to use to analyze sensor data from the treatment and analysis 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 system120may maintain data that maps surgery/wound types to models, sensor data, and the like.

At decision block412, the management system120or a user device130may determine whether to continue an existing regimen. If so, the process400may return to block408for 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 process400may 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 system120for use in determining and monitoring a treatment regimen.

At decision block414, the management system120or a user device130may determine whether to change the regimen that is to be performed by the module100. If so, the process400may return to block404, where the new regimen or change to existing regimen is determined. Otherwise, if treatment is not to continue, the process400may 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.6is a flow diagram of an illustrative process600that may be executed to analyze image(s) obtained from the module100. 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 system120via 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 and analysis module100is first configured for the patient, or when data is received for analysis. The management system120may 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 and analysis 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 system120may maintain data that maps surgery/wound types to models.

The process600or portions thereof may be executed by a user device130and/or management system120, individually or in combination. For example, process600may be performed to analyze module output data from the module100, such as during block410of process400. Portions of the process600will be described with further reference to the illustrative image analysis model system700shown inFIG.7.

The process600begins at block602. The process600may begin in response to an event, such as when the management system120obtains an image captured by the module100, when a user device130connects to the management system120to initiate analysis of an image (or set of images) captured by the module100, or on a predetermined or dynamically-determined schedule. In some embodiments, process600or 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. The module100may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120or a user device130may request the output data from the module100. In some embodiments, process600or portions thereof may be performed on-demand, such as when a user interacts with the module100, a clinician device130A, or a patient device130B. In this way, process600may produce real time or substantially real time analysis. When the process600is 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 process600or portions thereof may be implemented on multiple processors, serially or in parallel.

At block604, the system executing the process600may obtain one or more images of a body surface region. The image may be captured by the module100and provided to a user device130and/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 the module100. 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 process600may 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.7illustrates an example model system700that may be used to evaluate an image. In some embodiments, as shown, the model system700includes a classification model702and a regression model704. The models702and704may be implemented as artificial neural networks. For example, the classification model702may be implemented as a convolutional neural network (“CNN”) trained to classify images in any number of classes, and the regression model704may be implemented as a deep neural network (“DNN”) trained to generate scores.

The classification model702may be trained to classify an image as depicting one of a set of conditions or condition severities. For example, the classification model702may 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, the classification model702may 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, the classification model702may be a ResNet-152 model.

The management system120or 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 system120may train the classification model702using the training data input, and the resulting trained classification model702may 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, the classification model702includes an image input layer720at which image data710is 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 layer724may be structured as a vector representation of the features generated by the model702from the image input data. This vector representation may serve as an image embedding730that may be input to other models of the model system700for evaluation and production of output other than the classification output that the classification model702is trained to generate. For example, the image embedding730may 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 block608the system executing the process600may generate classification output based on evaluation of the image. In some embodiments, output produced by the output layer726of the classification model702may include one or more classification determinations, such as data indicating the particular class, of the classes for which the model702is 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 process600may 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 or more sensors102of the module100, 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 process600may obtain embedding data representing the image being analyzed. For example, the embedding data may be generated during evaluation of the image by the classification model702, as described in greater detail above.

At block614, the system executing the process600may 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 model704of the model system700shown inFIG.7may 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 system120or 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 system120may train the regression model704using the training data input, and the resulting trained regression model704may be deployed for use in analyzing images and additional data to generate state scores.

In the embodiment illustrated inFIG.7, the regression model704includes an image embedding and contextual data input layer740at which an image embedding730and contextual input data732are accepted, one or more hidden layers742, and a scoring output layer744. The scoring output layer744may 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 block616the system executing the process600may generate scoring output based on evaluation of the image embedding and contextual data using the scoring model. For example, output produced by the output layer744of the regression model704may include one or more scores, as described above.

Example Process for State Change Analysis

FIG.8is a flow diagram of an illustrative process800that may be executed to analyze image(s) obtained from the module100and determine a change in state of a body surface region over time. The process800or portions thereof may be executed by a user device130and/or management system120, individually or in combination. For example, process800may be performed to analyze module output data from the module100, such as during block410of process400.

The process800begins at block802. The process800may begin in response to an event, such as when the management system120obtains an image captured by the module100, when a user device130connects to the management system120to initiate analysis of an image (or set of images) captured by the module100, or on a predetermined or dynamically-determined schedule. In some embodiments, process800or 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. The module100may be programmed to initiate the capture and/or transfer of the output data, or another system such as the management system120or a user device130may request the output data from the module100. In some embodiments, process800or portions thereof may be performed on-demand, such as when a user interacts with the module100, a clinician device130A, or a patient device130B. In this way, process800may produce real time or substantially real time analysis. When the process800is 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 process800or portions thereof may be implemented on multiple processors, serially or in parallel.

At block804, the system executing the process800may obtain an image of a body surface region. The image may be captured by the module100and provided to a user device130and/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 the module100. The images may be obtained in the form of digital image files.

At block806, the system executing the process800may 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.7may 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 process800may 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 process800may determine whether a time interval for comparison has expired. If so, the process800may proceed to block812. Otherwise, if the time interval for comparison has not expired, the process800may 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 process800proceeds to block812on a daily, weekly, or monthly basis.

At block812, the system executing the process800may 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 block812may 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 device130or 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 and analysis module100includes a housing902, a circuit board904, and onboard battery906. The housing902as shown generally has an oval shape formed by a lower base908and an upper 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 the housing902can be removed, and in other embodiments, two or more side-by-side components can define part or all of the housing902. Additionally, the coupling between the base908and the lid910(or between other components that define the housing902) can be releasable or permanent.

In the illustrated embodiment, the lower base908has lower surface912with a concave shape that generally approximates a surface of the patient's body against which it will rest. The lower surface912preferably 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 base908to facilitate attachment of the module100to 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 the module100or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.).

With the lid910attached to the base908, the housing902defines 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 the module100. The space, however, should be minimized so as to provide the housing902with a slim profile and to be more form fitting. As such, the module100can 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 the module100to 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 the housing902has 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 the housing902can 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 the module100can 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, the lower surface912of the housing902supports a series of optical 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 other optical elements914that 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/processor104on the circuit board904controls the LEDs, and the battery powers the LEDs. Alternatively, the circuit board904can support the LEDs with the LEDs aligning with apertures in the bottom surface912of the housing902.

Each lens of the module100can be auto-focusing, rotatable or otherwise movable, and/or able to zoom in or out. These features allow the user—or controller104if 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 controller104control each lens with the battery906supplying power thereto. In other embodiments, the lens can be fix. Additional filters (either physical or software) can be used to enhance the images.

The lower surface912of the housing902also can include one or more apertures. Such apertures can form part of the treatment dispenser110to 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 the bottom surface912of the module housing902are drawn through the aperture(s) to reduce the pressure within that space.

Moreover, as noted above, the module100can also or alternatively provide waveform-based treatments, such as ultraviolet light or ultrasound. The treatment dispenser110for such treatments may include corresponding emission devices, such as ultraviolet light emitting diodes (as part of an array of LEDs supported by the circuit board904or the bottom surface912of the housing902) and/or ultrasonic transducers. The ultrasonic transducers can extend through or be supported on the lower surface912of the module housing902.

The printed circuit board904can be rigid but preferably is flexible, and supports and interconnects a plurality of the module's components including the controller/processor104, sensors102, data storage106, and network interface108. In some embodiments, the circuit board904also can support and interconnect at least some components of the treatment dispenser110and/or the fluid treatment storage112. For example, in some embodiments, the treatment dispenser110can include a dispensing medicant pump or the like that draws fluid from the fluid treatment storage112when operated by the controller104.

At least some of the sensors102are positioned on the printed circuit board904to correspond to the apertures and lens(es) supported by the lower surface912of the housing902. For example, the camera sensor102is located on the printed circuit board904such that it aligns with a lens or aperture on the lower surface912of the housing base908when the printed circuit board904is positioned and secured in the housing902. In some embodiments, this position lies generally at the center of the lower surface912.

The battery906supplies power to the components on the printed circuit board904and to the LEDs on the lower surface912of the housing902, and is attached to these components by one or more detachable leads. The battery906preferably is rechargeable either by an external port on the housing902or by induction. The size of the battery preferably allows the module100to operate for at least one day before requiring charging, but is not too large to dramatically increase the module's profile. In some embodiments, the battery906can be replaced while the module100is attached to the patient by removing the housing upper lid910and disconnecting and replacing the battery906.

In some embodiments such as the one shown inFIG.9, the module100also can include a digital screen displace916(e.g., a touch screen) on the upper surface of the module, for example on the upper 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. The module100can 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). The module100will 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 button918positioned on its upper lid910

While in the illustrated embodiment ofFIG.9the battery906and all of the components attached to the printed circuit board904are located within the module housing902, in other embodiments, such as seen inFIG.10, certain components of the module100can be located in a separate device1002that is attached to the module100. For example, some or all of the battery, processor, data storage, network interface can be located in the separate device1002and attached to the module100by a cable1004. This approach allows the module100to be slimmer and more form fitting; allows the module100to be fully enclosed/wrapped and controlled without taking off bandages; and reduces the profile and weight over the patients' wound area. The separate device1002can be similarly worn by the patient at a location remote from the wound or be attached to the worn module100when gathering data (e.g., when imaging).

The module100can 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.9illustrates, the module100can be form fit on and worn outside an associated wrap920. The wrap920includes an aperture922sized to receive at least the lower surface912of the module100. Interconnecting structures operate between the module housing902and the wrap920to secure the module100to the wrap920. In some embodiments, the module100can be released from the wrap920, in others its permanently affixed. The wrap920preferably 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 large central portion924to support the module100on the patient. In the illustrated embodiment, the wrap920includes two pairs of legs926,928that extend from the central section924. Each leg parings926,928interconnects using a hook-and-loop fastener (e.g., Velcro®). That is, one leg926,928includes the loop portion and other corresponding leg926,928includes the hook portion. Each leg pairings926,928can be wrapped around the patient—for example, around the patient's forearm—and attached to each other. In this manner, the wrap920secures the module100onto the patient's skin. The wrap920additionally can include an adhesive layer on its lower surface in some applications.

By way of additional examples,FIG.11illustrates the module100attached to a patient using standard adhesive coverings1102. In this example, gauze1104is located between portions of the module100and patient's skin, beneath the coverings1102.FIG.12illustrates another example with the module100attached beneath or embedded within a wearable medical article such as a wrap1202. In some embodiments, the module100can 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, the housing902of the module100may be form, in whole or in part, from a material configured to permit wireless communication from a network interface108within the housing. If the network interface108is or includes a high-speed wireless antenna, such as a 5G antenna, the housing902may be formed of material that does not interface, or does not substantially interfere, with communications to and/or from the network interface108. For example, the housing902may 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.13Ais a top plan view of another embodiment of the treatment and analysis module100.FIG.13Bis a cross-section view through the module100inFIG.13A. In the illustrated embodiment, the module100comprises a housing1302forming a receptacle1308. In the illustrated embodiment, an outer surface of the housing1302has a generally tapering oval shape. Of course, the shape of the housing1302is not limited to the illustrated shape and can instead have any other shape. For example, the shape and structure of the housing1302can differ and preferably will be suited for specific applications. While in the illustrated embodiment the housing1302has 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, the module100includes the network interface108(FIG.20). The network interface108allows the module100to transmit and receive data. The network interface108can 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, the network interface108and/or the power interface109can include one or more connectors accessible through the housing1302. Of course, in embodiments that wirelessly transmit and receive data and/or receive wireless power, the module100need not include accessible connectors accessible through the housing1302.

In certain embodiments, the housing1302comprises a flange1303. In certain embodiments, the flange1303extends in an outward direction from a lower opening (FIG.17) into the receptacle1308. In the illustrated embodiment, a distance the flange1303extends 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 the module100or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.). The flange1303may be mounted to or embedded within the surgical foam pad.

In certain embodiments, the module100comprises a platform1320. In certain embodiments, the platform1320is configured to be secured, directly or indirectly, to the patient. In the illustrated embodiment, the platform1320has a generally oval planar shape. Of course, the platform1320can have any shape. In the illustrated embodiment, at least a portion of the platform1320extends beyond an outer perimeter of the flange1303to increase a contact area between the module100and the patient. In certain embodiments, a lower surface of the platform1320has 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 the platform1320has a sufficient size to extend over and beyond the margins of the patient's wound that it is designed to cover. In certain embodiments, the platform1320has a higher degree of flexibility than the housing1302to allow the platform1320to 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 the platform1320for facilitating attachment of the module100to the patient. In certain embodiments, the platform1320includes an adhesive for adhering the module100to the patient.

In certain embodiment, the housing1302and the platform1320are manufactured as separate structures before being assembled together. In certain embodiments, the housing1302and the platform1320are assembled using an adhesive or other coupling structure known to a person having ordinary skill in the art. In certain embodiment, the housing1302and the platform1320are manufactured as a unitary structure. In certain embodiments that do not include the platform1320, the flange1303of the housing1302can instead be sized and shaped to be secured, directly or indirectly, to the patient.

In the illustrated embodiment, the platform1320comprises an opening1322aligned with the lower opening into the receptacle1308. In this way, the platform1320does not block access to the receptacle1308when the housing1302is coupled to the platform1320.

In certain embodiments, one or more sensors/components are located in the receptacle1308. 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 a camera sensor1301and a battery1306. As is explained below, in certain embodiments, the camera sensor1301and the battery1306are configured to be separately removable from the receptacle1308for ease of recycling.

In the illustrated embodiment, the camera sensor1301is disposed on a printed circuit board (“PCB”)1304. In embodiments that include the PCB1304, the PCB1304can be rigid but preferably is flexible, and supports and interconnects a plurality of the one or more sensors/components. For example, in certain embodiments, the PCB1304supports not only the camera sensor1301but also additional sensors/components. In certain embodiments, the camera sensor1301is configured as a standalone device disposed in the receptacle1308along with the battery1306. In certain embodiments, no PCB1304is employed.

In certain embodiments, the module100comprises a cover1310. In certain embodiments, the cover1310is sized and shaped to releasably secure in the lower opening into the receptacle1308. When the cover1310is attached to the housing1302, the receptacle1308is defined therebetween. In certain embodiments, the receptacle1308is sufficiently large to house the one or more sensors/components. In embodiments that include the PCB1304supporting the one or more sensors/components, the receptacle1308is sized to house the PCB1304(with all its sensors/components). In certain embodiments, a depth of the receptacle1308is selected to provide the field depth needed for the camera sensor1301or any other optical elements (e.g., for fluorescence imaging, light therapy, etc.) of the module100. A size of the receptacle1308can be minimized so as to provide the housing1302with a slim profile and to be more form fitting. As such, the module100can 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 the module100to 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 the module100to 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 the module100. In this way, the wound or area of interest on the patient is viewable by the camera sensor1301.

In certain embodiments, a thickness of the dressing placed between the skin of the patient and the platform1320is selected to achieve a desirable spacing between the housing1302and the skin of the patient. For example, in certain embodiments, thicker (or multiple layers) dressing can be selected to increase a distance between the housing1302and the skin of the patent. In this way the housing1302can move from a low-profile state to a raised-profile state. This adjustability can be advantageous since it changes a field of view of the camera sensor1301. In some embodiments, a first view may be a wider-angle view than a second view due to the optical configuration of the camera sensor1301. For example, the camera sensor1301may 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, the module100and/or the camera sensor1301may 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 the module100to transitioning the module100from the low-profile state to the raised-profile state and vice versa.

FIG.14Ais a left isometric view of the module100fromFIG.13Ashowing the platform1320of the housing1302configured to be secured relative to the patient.FIG.14Bis a right isometric view of the module100fromFIG.13A. In certain embodiments such as the one shown inFIGS.14A-B, the module100also can include an on-off button1318. In certain embodiments, the module100comprises a display (not shown) and/or one or more indicator lights1344on an upper surface of the housing1302. In certain embodiments, the display and/or indicator lights1344provide information to the healthcare worker or patient, for example, to indicate a low battery condition. In certain embodiments, the flashing of the indicator light1344can 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. The module100can operate a similar UI/UX to the that used with the user device130to provide controls for the module and/or to communicate data (e.g., an image of the covered wound). The module100can include a screen driver and additional processing software or firmware for this purpose.

FIG.15Ais a back isometric view of the module100fromFIG.13Ashowing an aperture1312in the cover1310aligned with a camera lens1324of the camera sensor1301.FIG.15Bis a back isometric view similar toFIG.15Aexcept the cover1310is opaque.FIGS.16A and16Bare back isometric views of the module100fromFIG.13A.

As is illustrated inFIGS.15A and16A, the camera sensor1301is supported by the PCB1304. In the illustrated embodiment, the camera sensor1301is positioned on the PCB1304to correspond to the aperture1312in the cover1310. In this way, the camera lens1324has an unobstructed view of the wound or area of the patient's skin. In certain embodiments, the cover1310need not comprise the aperture1312. For example, in certain embodiment, a portion of the cover1310that is aligned with the camera lens1324is transparent allowing the camera lens1324to 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 the receptacle1308by one or more fasteners1334so as to inhibit undesirable movement of the camera sensor1301relative to the module100. For example, the camera sensor1301can be located on the PCB1304such that the camera sensor1301aligns with the aperture1312in the cover1310when the PCB1304is positioned and secured in the housing1302and the cover1310is secured to the opening into the receptacle1308. In some embodiments, this position lies generally at the center of the cover1310. In certain embodiments, the aperture1312is sized so as to provide a close fit with a perimeter of the camera sensor1301. In this way, the aperture1312can further inhibit undesirable movement of the camera sensor1301relative to the module100.

In certain embodiments, the cover1310comprises an outer portion1326and an inner portion1328. In certain embodiments, the outer portion1326has a generally planar shape. In certain embodiments, the inner portion1328is sized and shaped to connect an inner edge of the outer portion1326with the aperture1312. In certain embodiments, the inner portion1328forms a recess or concave shape in the back of the housing1302. In certain embodiments, by recessing the aperture1312within the housing1302, the camera sensor1301is supported above the patient's skin when the cover1310is secured to the opening in the receptacle1308. In certain embodiments, by raising the camera lens1324away from the patient's skin, the camera sensor1301achieves a desirable field of view. As explained above, the module100can comprises additional structures (dressing thickness and/or manual application of force) to further move or adjust the camera sensor1301between a low-profile state and a raised profile state.

FIG.17is an exploded view of the module100fromFIG.13Ashowing the PCB1304and the battery1306removed from the receptacle1308.FIG.18is another exploded view of the module100fromFIG.13Ashowing the PCB1304and the battery1306removed from the receptacle1308. In the illustrated embodiment, the camera sensor1301is disposed on the PCB1304. The PCB1304can support one or more sensors/components including the camera sensor1301. In certain embodiments, the one or more sensors/components comprise any of the sensors/components described with respect toFIGS.1,2and20(e.g., controller/processor104, sensors102, optical elements1314, led indicators1338, battery safety circuit1340, data storage106, power interface109, and/or network interface108, etc.). In certain embodiments, the PCB1304also can support and interconnect at least some components of the treatment dispenser110and/or the fluid treatment storage112. For example, in some embodiments, the treatment dispenser110can include a dispensing medicant pump or the like that draws fluid from the fluid treatment storage112when operated by the controller104.

In certain embodiments, the receptacle1308comprises a mounting structure for connecting to components (e.g., PCB1304, battery1306, cover1310) of the module100. In certain embodiments, the components secure to the housing1302via 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 the receptacle1308comprises one or more receptacles1330and/or guide walls1332. The one or more receptacles1330are configured to receive one or more fasteners1334so as to connect the components to the housing1302. For example, in certain embodiments, a fastener1334secures the PCB1304to the housing1302. In certain embodiments, the battery1306is located between the one or more guide walls1332while also being sandwiched between the PCB1304and the back wall of the receptacle1308. In this way, once the fastener1334securing the PCB1304to the housing1302is removed, the PCB1304and the battery1306are easily removed from the receptacle1308.

FIG.19Ais a back plan view of the module100fromFIG.13Ashowing the aperture1312in the cover1310aligned with the camera lens1324of the camera sensor1301.FIG.19Bis a back plan view similar toFIG.19Aexcept the cover1310is opaque. In certain embodiments, a portion of the cover1310is press fit into the housing1302securing the cover1310to the housing1302. In the illustrated embodiment, the cover1310comprises one or more apertures1336for receiving the one or more fasteners1334(not shown). In certain embodiments, once the one or more fasteners1334are disengaged from the one or more receptacles1330, the cover1310can be removed to then lift out components from the receptacle1308, 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, the battery1306and other components meet requirements for disposal in a landfill. In other embodiments, the module100is reusable. For example, the reusable module100can be configured for removal and replacement of the battery1306along with the healthcare provider being able to change an electronic identifier of the module100for the new patient.

FIG.20is a schematic view of the module100fromFIG.13A. The treatment and analysis module100may include one or more sensors102to monitor and generate data regarding user skin characteristics. In certain embodiments, the one or more sensors102may include a visualization element, such as the camera 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 or more sensors102may 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 or more sensors102may also or alternatively include an accelerometer to assess movements and activities of the patient. In certain embodiments, the one or more sensors102may also or alternatively include a pH sensor to determine the pH level of the user's body surface region. In some embodiments, the one or more sensors102may 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. The example sensors102described herein are illustrative only, and are not intended to be limiting, required, or exhaustive of the sensors102that may be included in a treatment and analysis module100.

The treatment and analysis module100may include the processor/controller104, such as a system on a chip (“SOC”) or other microprocessor to process data and commands. In some embodiments, the processor104may process data from the one or more sensors102and/or a data store106, execute one or more analysis or detection algorithms, receive and execute commands from other devices via the network interface108, or the like. In some embodiments, the data store106may be a substantially persistent data store, such as flash memory, hard disk, or the like.

The network interface108may 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, the network interface108can utilize RF, infrared or other wireless circuitry (receiver or transmitter, or transceiver) to communicate with a remote device. In certain embodiments, the network interface108is implemented as a Wi-Fi module and/or a cellular module. In certain embodiments, the network interface108comprises an antenna.

In the illustrated embodiment, the network interface108is on the same PCB1304as other electronics and located within the housing1302. In certain embodiments, the Wi-Fi module connects the components of the PCB1304to a LAN via a Wi-Fi connection. In certain embodiments, multiple modules100with multiple network interfaces108connect to a single LAN.

In certain embodiments, the network interface108comprises 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 of optical elements1314, for example, LEDs and lasers. The optical elements1314can 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, the optical elements1314provide waveform-based treatments, such as ultraviolet light or ultrasound. In certain embodiments, the optical elements1314emit UV light (e.g., UVA (315-400 nm), UVB (2800-315 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, the optical elements1314can 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, the optical elements1314emit low level laser therapy for treatment of the wound. In certain embodiments, microwave-generated ultraviolet plasma may be used therapeutically.

In certain embodiments, the optical elements1314are 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, the optical elements1314can 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/controller104on the PCB1304can control the optical elements1314while the battery1306powers the optical elements1314. Alternatively, the PCB1304can support the optical elements1314with the optical elements1314aligned with apertures in the cover1310of the housing1302or employ a transparent cover1310without the need for apertures.

In certain embodiments, the battery1306supplies power to the one or more sensors/components of the module100. In certain embodiments, the battery1306attaches to the components by one or more detachable leads. The battery1306can be rechargeable either by an external port on the housing1302or by inductive charging (i.e., wireless) as explained above. In certain embodiments, the battery1306is a rechargeable lithium ion battery with a voltage of 3.7. Of course, the type and capacity of the battery1306are not limited to the listed type and value and instead can be any other type of battery1306having any other capacity or value. In certain embodiments, the battery1306is about 4.5 mm thick, 52.5 mm long, and 20.7 mm wide. The dimensions of the battery1306can 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 the exemplary battery1306dimensions provided above. The size of the battery1306can be selected to allow the module100to operate for at least one day before requiring charging. In certain embodiments, the battery1306can be recharged while the module100is attached to the patient wirelessly or via a wired connection.

In certain embodiments, the module100includes a battery safety circuit1340. For example, in certain embodiments, the battery safety circuit1340is configured so that the module100complies 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 the battery1306and its re-chargeable characteristics comply with the standard. In certain embodiments, the battery safety circuit1340allows safe inductive charging of the battery1306. In certain embodiments, the battery safety circuit1340is incorporated on the PCB1304.

In certain embodiments, the module100includes the camera lens1324. In certain embodiments, the camera lens1324can be auto-focusing, rotatable or otherwise movable, and/or able to zoom in or out. In certain embodiments, the module100includes a manual slide control for angle and viewing. In certain embodiments, the manual slide control is located on a side of the housing1302to allow the healthcare provider to adjust the lens1324to cover the best viewing distance and angle. In certain embodiments, the module100includes a motor slide control for angle and viewing. In certain embodiments, the motor slide control can be controlled remotely. These features allow the user (or controller104if 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/controller104can control the camera lens1324with the battery1306supplying power thereto. In other embodiments, the lens1324can be fix. Additional filters (either physical or software) can be used to enhance the images.

In certain embodiments, the module100includes the treatment dispenser110and/or the fluid treatment storage112. For example, in some embodiments, the treatment dispenser110can include a dispensing medicant pump or the like that draws fluid from the fluid treatment storage112when operated by the processor104. A lower surface of the module100can include one or more apertures. Such apertures can form part of the treatment dispenser110to 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 pressure wound therapy module1342. For example, in certain embodiments, the negative pressure wound therapy module1342can draw fluids from within a space between the wound and the lower surface of the module100to reduce the pressure within that space. In certain embodiments, the negative pressure wound therapy module1342comprises 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.21Ais a plan top view of an exemplary embodiment of the PCB1304(e.g., including camera sensor1301) fromFIG.13A.FIG.21Bis a back side view of the PCB1304fromFIG.21A.FIGS.21A-Billustrate certain of the one or more sensors/components of the module100but are not intended to limit the number of components that can be carried by the PCB1304to those illustrated. One or more of any of the components disclosed herein can be carried by the PCB1304(or multiple PCBs1304) and/or module100.

In certain embodiments, the PCB1304comprises an antenna1348. In certain embodiments, the antenna1348is configured as a planar inverted-F antenna (PIFA). In certain embodiments, the network interface108of the PCB1304comprises a wireless chip. In certain embodiments, the wireless chip is configured as a Wi-Fi and/or Bluetooth chip. In certain embodiments, the network interface108of the PCB1304comprises a port for data transmission. In certain embodiments, the port is configured as a serial peripheral interface (SPI) port. In certain embodiments, the antenna1348and the port are employed by the network interface108to receive and send data by the module100. The network interface108may 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, the PCB1304comprises one or more buttons1346for controlling/programming the components disposed on the PCB1304. In certain embodiments, the PCB1304comprises one or more LED indicators1344.

In certain embodiments, the power interface109can 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, the power interface109is configured as a USB port. Of course, the power interface109need not be configured as a USB port and instead can be configured as any other type of port for receiving power. In certain embodiments, the power interface109supplies power to all of the components of the PCB1304. In certain embodiments, the data store106may be a substantially persistent data store, such as flash memory, hard disk, or the like.

FIG.22Ais a perspective view of the PCB1304fromFIG.13A.FIG.22Bis a front plan view of the PCB1304fromFIG.22A.FIG.22Cis a side view of the PCB1304fromFIG.22B.FIG.22Dis an upper plan view of the PCB1304fromFIG.22A. The dimensions disclosed inFIGS.22A-Dare only exemplary and are not intended to limit the size of the PCB1304in any way. As explained above, in certain embodiments, the dimensions of the battery1306can 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 the exemplary battery1306dimensions provided above.

FIG.23Ais a top plan view of another embodiment of the treatment and analysis module100that is similar to the module100ofFIG.13Aexcept the housing1402comprises one or more legs1404which telescope from the housing1402. In certain embodiments, the one or more legs1404are movable between extended and retracted configurations. In certain embodiments, the one or more legs1404are fixed in the extended configuration.

In certain embodiments, the one or more legs1404can extend from the module100at a location above or below the platform1320. For example, the one or more legs1404inFIGS.23A to26Bextend from the housing1402at a location that is above the platform1320while the one or more legs1404inFIGS.27A to29Bextend from the housing1502at a location that is below the platform1320. In certain embodiments that include multiple legs1404, the multiple legs1404can be internally linked so that the multiple legs1404move in unison when any one of the legs1404is moved between the extended and retracted configurations.

When in the extended configuration, the module100can be placed over larger wound areas than when the one or more legs1404are in the retracted configuration. In certain embodiments, the one or more legs1404allow for the module100to be centered or placed in any location on the patient with the one or more legs1404extending beyond an outer perimeter of the platform1320. In certain embodiments, the one or more legs1404extend to a dressing encircling the wound. In certain embodiments, the one or more legs1404are 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 the module100or components thereof (e.g., optical access for a camera sensor; environmental access for a temperature or moisture sensor, etc.). One or more legs1404may extend to maintain the module100at a height above the body surface and/or to be embedded within the surgical foam pad.

In certain embodiments, the one or more legs1404provide 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 or more legs1404. In certain embodiments, the module100can include an actuating system (e.g., one or more electric or pneumatic actuators) to extend the one or more legs1404or 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 or more legs1404inFIG.23Aare in the extended configuration. The illustrated embodiment comprises four legs1404. However, the module100can comprise more or fewer legs1404than is illustrated inFIG.23A.FIG.23Bis a cross-section view through the module100inFIG.23Ashowing the one or more legs1404in the extended configuration. In the illustrated embodiment, each leg1404comprises a rod1406having a distal end1408. In certain embodiments, the rod1406and the distal end1408comprise different materials. For example, in certain embodiments, the rod1406comprises stainless steel while the distal end1408is an over molded plastic to the rod1406. Of course the material of the rod1406need not be stainless steel and instead can be any other material.

As is illustrated inFIG.23A, an outer portion1412of the distal end1408can have a generally U-shape as viewed inFIG.23A. As also illustrated inFIG.23A, an inner portion1414of the distal end1408can have a surface that matches a pad1416on an outer surface of the housing1402. In certain embodiments, the inner portion1414contacts the pad1416when the leg1404is in the retracted configuration. Of course the shapes of the inner portion1414and pad1416are not limited to the illustrated shapes.

FIG.24Ais a top plan view of the module100fromFIG.23Ashowing the one or more legs1404in the extended configuration.FIG.24Bis a top plan view similar toFIG.24Aexcept the one or more legs1404are in the retracted configuration.FIG.25Ais a back plan view of the module100fromFIG.23Ashowing the one or more legs1404extending beyond an outer perimeter of the platform1320when in the extended configuration.FIG.25Bis a back plan view similar toFIG.25Aexcept the one or more legs1404are in the retracted configuration hidden behind the platform1320. In certain embodiments, the distal end1408is sized larger than the rod1406. In this way, the distal end1408comprises a contact surface1410that has a width greater than a width of the rod1406. In certain embodiments, the contact surface1410provides sufficient stability to the module100when the contact surface1410is secured relative to the patient.

FIG.26Ais a left isometric view of the module100fromFIG.23Ashowing the one or more legs1404in the extended configuration.FIG.26Bis a right isometric view of the module100fromFIG.23Ashowing the one or more legs1404in the extended configuration.

FIG.27Ais a top plan view of another embodiment of the treatment and analysis module100that is similar to the module100ofFIG.23Aexcept the one or more legs1404extend from the housing1502at a location below the platform1320. In the illustrated embodiment, the one or more legs1404extend from the cover1510.FIG.27Bis a cross-section view through the module100inFIG.27Ashowing the one or more legs1404in the extended configuration.

In certain embodiments, the one or more legs1404are movable between extended and retracted configurations. In certain embodiments that include multiple legs1404, the multiple legs1404can be internally linked so that the multiple legs1404move in unison when any one of the legs1404is moved between the extended and retracted configurations.

FIG.28Ais a back plan view of the module100fromFIG.27Ashowing the one or more legs1404extending from the cover1510and in the extended configuration.FIG.28Bis a back plan view similar toFIG.28Aexcept the one or more legs1404are in the retracted configuration. In certain embodiments, the one or more legs1404provide 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 or more legs1404. In certain embodiments, the module100can include an actuating system (e.g., one or more electric or pneumatic actuators) to extend the one or more legs1404or 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 four legs1404. However, the housing1510can comprise more or fewer legs1404than is illustrated inFIG.28A. In the illustrated embodiment, each leg1404comprises a rod1406having a distal end1408. In certain embodiments, the rod1406and the distal end1408comprise different materials. For example, in certain embodiments, the rod1406comprises stainless steel while the distal end1408is over molded plastic to the rod1406. Of course the material of the rod1406need not be stainless steel and instead can be any other material.

As is illustrated inFIG.28A, an outer portion1412of the distal end1408can have a general arc shape as viewed inFIG.28A. As also illustrated inFIG.28A, the cover1510can comprise a channel1512sized and shaped to receive the distal end1408when the one or more legs1404are in the retracted configuration. In certain embodiments, the distal end1408is sized and shaped to match the channel1512in the cover1510. Of course the shapes of the distal end1408and the channel1512are not limited to the illustrated shapes.

FIG.29Ais a left isometric view of the module100fromFIG.27Ashowing the one or more legs1404in the extended configuration.FIG.29Bis a right isometric view of the module100fromFIG.27Ashowing the one or more legs1404in the extended configuration. In certain embodiments, the distal end1408is sized larger than the rod1406. In this way, the distal end1408comprises a contact surface1410that has a width greater than a width of the rod1406. In certain embodiments, the contact surface1410provides stability to the module100when the contact surface1410is secured relative to the patient.

In some embodiments, one or more legs1404may be integrated with a bracket (not shown) that is placed over or near the body tissue region of interest. In this configuration, the one or more legs1404may provide vertical height adjustment for a separate module100that 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 a module100with a wearable medical article, the examples are illustrative only and are not intended to be limiting. In some embodiments, the module100may 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.