Mobile documentation device for detecting skin lesions

EP4666287A1Pending Publication Date: 2025-12-24CUREVISION GMBH
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Patent Information

Application Number
EP2024705459
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-02-14
Filing Date
2024-02-14
Publication Date
2025-12-24

AI Technical Summary

Technical Problem

Conventional two-dimensional image documentation systems for wounds are unreliable due to measurement inaccuracies, especially for large lesions, as recordings can vary with lighting, recording angle, and ruler position, making them unsuitable for precise assessment of wound healing.

Method used

A mobile documentation device with multiple recording modules, including optical, thermal, and hyperspectral cameras, and sensors, capable of three-dimensional imaging and data acquisition, which provides reproducible lighting and precise data storage for detailed wound analysis, allowing for simultaneous recording of crucial parameters like wound size, tissue vitality, and healing progress.

Benefits of technology

Enables reliable, precise, and efficient documentation of wound healing processes, facilitating timely and effective wound care by providing accurate, reproducible 3D models and real-time monitoring of wound parameters, reducing patient strain and healthcare costs while supporting objective assessment of treatment efficacy.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a mobile documentation device (100) for acquiring data relative to skin lesions, for example wounds, the device comprising a plurality of capturing modules (101a, 101b, 101c). Each capturing module (101a, 101b, 101c) comprises at least one camera (103) for detection and at least one light source (105) for illumination of the skin lesion. The capturing modules (101a, 101b, 101c) are and / or the mobile documentation device (100) is interconnected in a structure the periphery of which is closed, i.e. not as a ring, ellipsis, rectangle, each having a central opening or the like. The invention also relates to a system.
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Description

[0001] Description

[0002] Mobile documentation device for the recording of skin lesions

[0003] The present invention relates to a mobile documentation device according to claim 1 as well as a system according to claim 34 and a method according to claim 38 or according to the preambles or generic terms of these claims.

[0004] When documenting healing-specific parameters of wounds or skin lesions, a two-dimensional image of the wound or skin lesion is typically taken with a conventional digital camera. A ruler held over the image is intended to enable an objective assessment of the wound size.

[0005] Wound care for a patient is often performed by a variety of different medical professionals and / or over extended periods of time. Therefore, the course of treatment must be documented as accurately as possible so that all individuals or professionals involved can reliably assess whether the treatment measures taken so far are / were successful or whether complications have arisen.

[0006] The object of the present invention may be to provide a further documentation device that enables reliable and accurate documentation of the healing process of wounds and other skin lesions. Furthermore, a system and a method are to be proposed. The object of the invention is achieved by a mobile documentation device having the features of claim 1, as well as by a system having the features of claim 34 and a method having the features of claim 38.

[0007] The present invention relates to a mobile documentation device for the detection, data acquisition, evaluation, three-dimensional imaging and / or documentation of skin lesions, for example wounds.

[0008] The mobile documentation device (hereinafter also referred to as documentation device) has or is one or more recording modules (or exactly one such module), which in turn each comprise either at least one, usually optical, camera and optionally at least one light source and / or light source in the UV / IR range, or optionally at least one thermal imaging camera, a hyperspectral camera and / or an IR camera.

[0009] The light source, if present, serves to illuminate the wound or skin lesion (hereinafter referred to as "wound"), preferably without shadows. This allows images to be obtained independently of ambient lighting conditions and / or under reproducible lighting conditions, for example, using the optional optical camera(s).

[0010] The recording modules, or their housings, of the mobile documentation device are optionally connected to one another in an articulated manner by means of one or more joints, e.g. in order to be able to assume a completely or substantially arcuate arrangement. In this case, the recording modules or the housings receiving them are not connected to one another in a circumferentially closed structure, i.e. they are not connected to one another in the form of a ring, an ellipse, a polygon, each with a central opening, or the like. Alternatively, the recording modules, or their housings, are not connected to one another in an articulated manner.

[0011] Optionally, the mobile documentation device does not have a circumferentially closed structure.

[0012] In use, the mobile documentation device is placed over the affected wound of the patient, for example, it is set up, or it is held by the user over the affected area.

[0013] According to the invention, a system is further proposed which has one or more mobile documentation devices, preferably according to the invention.

[0014] In addition to the at least one mobile documentation device, the system has a data storage device for storing images or image data of wounds of one or more patients. The images and / or other patient data can be recorded using the same mobile documentation device or different ones, which are preferably identical in design.

[0015] The system also includes a computer unit for processing images or image data or other information captured by the documentation device. The computer unit can be or include a control device, such as that disclosed herein. Furthermore, the system includes an output device, wherein a device of the system, e.g., the control device, is programmed to output information relating to the captured images.

[0016] The method according to the invention relates to the use of a documentation device or system according to the invention when recording data on a skin lesion or wound.

[0017] Embodiments of the invention may comprise some, some, or all of the following features in any combination, unless this is recognizably technically impossible for a person skilled in the art. Advantageous developments of the present invention are also the subject of the dependent claims and embodiments.

[0018] In all the following statements, the use of the expression "may be" or "may have" etc. is to be understood as synonymous with "is preferably" or "preferably has" etc. and is intended to explain embodiments of the invention.

[0019] Whenever numerical words are mentioned herein, the person skilled in the art will understand this as indicating a numerical lower limit. Unless this leads to a contradiction recognizable to the person skilled in the art, the person skilled in the art will therefore always read the term "a" or "an" as meaning "at least one" or "at least one". This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one", wherever this is recognizably technically possible to the person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein. Advantageous further developments of the present invention are each the subject of dependent claims and embodiments.

[0020] When an embodiment is mentioned herein, this represents an exemplary embodiment according to the invention.

[0021] If it is disclosed herein that the subject matter according to the invention has one or more features in a particular embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g., by way of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, for example, formulated as a negation, is also disclosed.

[0022] Whenever reference is made to "programmed" or "configured" herein, it is also disclosed that these terms are interchangeable.

[0023] In some embodiments, moreover, no connectors are provided or no other provisions are made to provide the receiving modules or the housings receiving them in a closed arrangement along the circumference of the mobile documentation device.

[0024] In some versions, the mobile

[0025] Documentation device a user interface

[0026] (GUI / graphical user interface) or a display. In certain embodiments, the user interface (GUI) or the display can be embedded or incorporated into the outer circumference of the arcuate or trapezoidal housing. The user interface or the display can be connected to an optional evaluation device, one or more of which can be present therein, and / or the recording modules and / or sensors and / or light sources and / or other components in the inner circumference of the housing so that measurements, data, images, etc. can be shown on the display and / or all components can be controlled, preferably via the user interface.

[0027] In some embodiments, the GUI serves to operate or control the mobile documentation device and / or to input required information. One, some, or all of the functionalities of the mobile documentation device described below can be implemented using the user interface or GUI, with the necessary devices, programming, etc., being available, for example, on the mobile documentation device or elsewhere in the system according to the invention.

[0028] In some embodiments, the mobile documentation device comprises multiple cameras, optionally one or more light sources, and optionally one or more distance sensors. All of these can optionally be provided in a common housing.

[0029] In some embodiments, the mobile documentation device comprises at least one light source for some or for each camera on both sides thereof, e.g. in front of and behind it, or to the left and right of it, which counteracts the formation of shadows and can contribute to better recording or model quality.

[0030] In some embodiments, the central housing section, also referred to herein as the body of the housing, has one, two or more of the cameras mentioned herein and optionally one or more sensors such as a distance sensor.

[0031] Cameras, distance sensors and / or other sensors can each be directed towards the same side of the mobile documentation device, for example towards the underside of the mobile documentation device and preferably towards the wound.

[0032] In some embodiments, a battery is provided to operate the mobile documentation device. Alternatively, a rechargeable battery is provided, which has a charging option known from the prior art. The battery or rechargeable battery can be embedded in the housing.

[0033] In some embodiments, the mobile documentation device has at least one handle with which the mobile documentation device can be held over the wound for use. Alternatively or additionally, finger grips, finger recesses, and / or the like can be provided.

[0034] Recesses or handles for holding the mobile documentation device as described herein can be provided in some embodiments and / or be suitable for enabling holding and / or operation of the mobile documentation device with just one hand. The recesses described herein can advantageously allow this. The second, free hand can be used to operate the mobile documentation device, e.g. to trigger the recording by the cameras. Gesture control can be used here, which can counteract or prevent blurring of the recordings caused by actuations e.g. on the mobile device itself to trigger the recording.

[0035] A storage device, if provided, may be part of the mobile documentation device or part of the system comprising the documentation device.

[0036] The storage device and the control device can be in signal communication with each other in a wired or wireless manner, at least during use of the documentation device, or can be prepared for this purpose.

[0037] When reference is made here to a signal or communication connection between two components, this can be understood as a connection that is already in use. It can also be understood as preparation for such a signal connection (wired, wireless, or implemented in another way), for example, by coupling the two components, such as by pairing, etc.

[0038] Pairing is a process that occurs in computer networks to establish an initial connection between computer units for the purpose of communication. The best-known example of this is establishing a Bluetooth connection, which connects various devices (e.g., smartphones, headphones) to one another. Pairing is sometimes also referred to as bonding.

[0039] In a further embodiment, the images captured by the recording modules and the measured / collected parameters are stored; a dedicated and prepared data storage device is provided in such embodiments. The data storage device can be part of the mobile documentation device or the system.

[0040] In some embodiments, the mobile documentation device according to the invention has at least one switching device by means of which the recording modules or their cameras and / or sensors are actuated. The switching device can be an actuating device and can also be referred to as such.

[0041] The recording modules or their cameras and / or sensors can be activated simultaneously, in particular; the control device can be programmed accordingly. Alternatively, the present invention also encompasses a successive actuation or activation of the individual recording modules or cameras and / or sensors, with or without a predetermined sequence, i.e., in any sequence or in a predetermined sequence.

[0042] In some embodiments, at least one of the recording modules has at least one thermal imaging camera. This can be provided in addition to or as an alternative to the optical camera disclosed herein and / or other cameras.

[0043] In some embodiments, at least one of the recording modules further comprises at least one sensor, in particular a temperature sensor, an IR sensor, one or more UV cameras or sensors and / or a color sensor.

[0044] In certain embodiments, the sensors are designed to determine or detect additional parameters that provide an indication of the healing process in the wound under consideration. These parameters can include qualitative or quantitative statements regarding the presence of histological observations such as fibrin, granulation tissue, necrotic tissue, etc.

[0045] According to the invention, the mobile documentation device can have more than one type of sensors in order to be able to make more precise statements.

[0046] For example, a temperature increase measured by means of an optional temperature sensor, for example over different examination times in which the documentation device according to the invention was used, can be an indication of a complication of the wound (inflammation or infection); alternatively, it can also be an indication of revascularization of the tissue that is favorable for healing if ischemia (reduced blood flow) was previously present.

[0047] Additional sensors, such as IR sensors or color sensors, can be provided according to the invention to supply further information and, for example, to expand or supplement the information received from the temperature sensor(s) in such a way that the clinical value of the temperature change can be determined more precisely. The values ​​determined by the sensors can provide indications of the development of the healing process (also documented over longer periods of time), e.g. with regard to the formation of granulation tissue or epithelialization of the wound surface, or indicate the development of complications such as infection(ies), inadequate blood circulation, or in the worst case, necrosis, etc.

[0048] In some embodiments, at least one of the recording modules and / or another section of the documentation device has at least one distance sensor, in others exactly one, in still others exactly or at least two distance sensors.

[0049] In some embodiments, the distance sensor can determine the correct positioning of the mobile documentation device, for example, so that it is always placed in the same location on the patient during successive measurements. The control device can be designed and / or programmed accordingly for this purpose.

[0050] In further embodiments, the distance sensor or distance sensors can be used or exclusively used to create or contribute to creating, for example, true-to-life 3D images of the wound, for example by determining the depth of the wound or by enabling correct reconstruction of the wound, e.g. in a 3D data model, since their sensor values ​​can allow conclusions to be drawn about the position of the cameras in space or in relation to one another at the moment the image is taken. An algorithm used, e.g. in the optional evaluation device, can use the distance values, for example when creating 3D models, views, evaluations or other activities. The same can apply to the optional inclination sensor(s) mentioned below.

[0051] In some embodiments, at least one of the recording modules and / or another section of the mobile documentation device has at least one inclination sensor. Inclination sensors can be provided to provide the user with information about how the mobile documentation device is being held at any given moment when holding it. A comparable principle is known from spirit levels. One or two inclination sensors indicate whether the spirit level is aligned "in the water" in one or two spatial directions. A mobile documentation device with inclination sensors can prompt the user through optical or other feedback to hold the documentation device straight or at the same inclination at different times, at least during each wound examination.The mobile documentation device, which is always held identically or at least comparable in at least one or more spatial directions, allows images to be taken at different times, which enables reconstruction or the creation of 3D models with comparatively less computing effort. This is all the more true if the height of the mobile documentation device above the wound at the moment the respective image was taken is known based on data from the distance sensor, or if the mobile documentation device is held according to the specifications of the distance sensor or the information determined by it.

[0052] In further embodiments, recording modules can be combined, i.e., they can have different camera and / or sensor types. In some embodiments, the mobile documentation device or its recording modules have a control device or are in signal communication with it during use.

[0053] In further embodiments, the control device is configured for automatic or manual control or regulation of the function of the camera(s) or the sensor(s).

[0054] In some embodiments, the control device is configured to automatically or manually calibrate cameras and / or sensors of the mobile documentation device and / or to adjust, influence and / or change setting parameters of the cameras and / or sensors, such as angular positions, for example relative to the wound or relative to each other.

[0055] In some embodiments, the control device is configured, for example, to adapt an angular setting of the camera(s) and / or the sensor(s) to the corresponding position on the body of a patient or to the specific area and depth of the wound with the aim of ensuring the best possible camera images or measured values ​​from the sensor(s).

[0056] In further embodiments, the control device can adjust the light source(s) so that the wound is illuminated essentially without shadows.

[0057] In some versions of the mobile

[0058] In the documentation device, the intensity and / or the orientation and / or the dimensions (size and shape parameters) of the light cone of the light source can be adjusted manually or automatically.

[0059] In some embodiments, the mobile documentation device has an evaluation device or is connected to an evaluation device. In some embodiments, the evaluation device is located elsewhere in the system, but not on the mobile documentation device.

[0060] The evaluation device is preferably configured or programmed to determine or collect data, to convert the data thus determined into images and / or to compare these images with other images which were calculated in particular based on earlier data.

[0061] In some embodiments, the evaluation device is configured to create three-dimensional models of wounds based on the data obtained by the mobile documentation device.

[0062] The model created by the evaluation device can, for example, represent physical parameters of the wound, such as area and depth, and / or physiopathological characteristics of the wound, such as temperature, discoloration, signs of tissue vitality, etc., which can be represented on the model, for example, as numbers or color codes.

[0063] 3D models (or their mathematical descriptions, their images, etc.) captured or generated on different days are stored in some embodiments. In some embodiments, they are compared with each other at the user's request or automatically, for example, to create a chronological documentation of the wound's progression.

[0064] An "ascertainment" or determination, especially of data and / or values, can be or include an investigation of existence or non-existence, a recording, a recording, a measuring, a collecting, an evaluation, a processing, a comparison, an estimation, an assessment or estimation, an inference, a calculation, a preservation, an attainment and / or a recognition.

[0065] In some embodiments, the evaluation device can make prognostic statements regarding the course of the healing process or can trigger an alarm if signs of a complication in wound healing have occurred. This can be done, for example, by comparing with stored reference data, reference courses, reference images, by using reference databases, using artificial intelligence, etc.

[0066] In some embodiments, the evaluation device can be configured as a user interface, be connected to such a interface—preferably wirelessly or wired—or have such a interface by means of which the cameras, sensors, light sources, and / or control devices of the recording modules can be controlled. In some embodiments, it can also comprise the switching device or be in signal communication with it. In some embodiments, the evaluation device can be controlled by voice and / or gestures and can be configured or programmed accordingly.

[0067] In some embodiments of the mobile documentation device, the evaluation device is integrated into at least one of the recording modules or into the housing of the mobile documentation device.

[0068] In some embodiments, at least the evaluation device has a display for data reproduction and / or for controlling the mobile documentation device and / or as a user interface for inputting control signals for controlling the mobile documentation device.

[0069] In some versions the display is a touchscreen.

[0070] In some embodiments, the at least one evaluation device is physically separate from the mobile documentation device, is in wireless signal communication with it, or is prepared for this purpose. Optionally, the evaluation device is configured to remotely control the documentation device.

[0071] In some embodiments, the evaluation device can exchange data with remote computer systems and be prepared or programmed accordingly and / or be in signal communication or prepared for this purpose, for example to enable remote diagnostics.

[0072] In some embodiments, the evaluation device is part of the inventive set or system. It can be located on the documentation device or externally.

[0073] In some embodiments, the mobile documentation device can be sterilized or disinfected.

[0074] In some embodiments, the evaluation device is programmed to cause both the first camera to take a 3D image and the second camera to take a 2D image.

[0075] In some embodiments, the 3D image is or results in a point cloud.

[0076] In some embodiments, the evaluation device is programmed to trigger both recordings, i.e. the 3D and the 2D recording, after the user has activated only one triggering device, for example after pressing only one trigger button, or when the user performs only one gesture.

[0077] In some embodiments, the evaluation device is programmed to take both images, i.e. the 3D and the 2D image, simultaneously or at least with an overlap in time.

[0078] By triggering the 2D and 3D cameras simultaneously, it can be ensured that the wound detected in the 2D image and the 3D model from the 3D image match. In this way, a high level of accuracy of the system can be achieved. In some embodiments, the evaluation device is programmed to determine a mask from the 2D image or the information underlying it, in particular image information, which mask corresponds to a section of the wound, preferably the edge of the wound, in the 2D image or is or will be assigned to this, wherein an inner region of the mask is in turn identical to this surface.

[0079] In some embodiments, the mask is a binary mask (black / white; 0 / 1; etc.). In this case, the assignment can be performed using binary segmentation, e.g., wound = white, non-wound = black.

[0080] In some embodiments, the mask is a contour or boundary, e.g., having a width, depth, or thickness of one pixel.

[0081] In some embodiments, the mask has a circumferentially closed structure that can define an interior region of the mask.

[0082] The mask can be obtained by morphological erosion and subtraction from the source image or original.

[0083] In some embodiments, the evaluation device is programmed to define a region of the 3D image which, after or by means of projection of the mask onto the 3D image, is assigned to the edge or its course or the interior of the mask, or lies within the contour or boundary of the mask or is assigned to this, possibly circumferentially closed, region. In some embodiments, the evaluation device is programmed to extract the previously defined region of the 3D image, or a region defined by the contour or boundary, from the 3D image.

[0084] In some embodiments, the evaluation device is programmed to evaluate the extracted area.

[0085] In some embodiments, the evaluating is or includes defining a plane in the 3D image that includes the defined edge, or at least three pixels that lie on or at the edge.

[0086] In some embodiments, methods or algorithms can be used to determine the shape or orientation of points from a point cloud and, based on this, to calculate a plane in which most of these points lie. Such

[0087] Methods / algorithms are known to those skilled in the art. Reference should also be made to the least error method or least squares method.

[0088] In some embodiments, this plane can be a wound entry plane within the 3D image.

[0089] In some embodiments, the evaluation is or includes determining the distances from a plurality of pixels of the 3D image to the plane encompassing the edge.

[0090] In some embodiments, these distances may be color-coded. In some embodiments, this may be used to generate a depth map.

[0091] Methods for calculating distances between individual points, here for example the base of the wound, and a surface, here for example the wound entry area, are known to the person skilled in the art.

[0092] In some embodiments, the evaluation is or includes determining the area of ​​the wound bed underlying the surface using the determined distances.

[0093] In some embodiments, the evaluating is or includes measuring the extracted area.

[0094] In some embodiments of the mobile documentation device or the system according to the invention, the output information is or contains information about at least one dimension of the wound, such as depth, width, length, area, number of pixels, pixel content, etc.

[0095] In some embodiments of the mobile documentation device or system, the information is or contains details about at least one, in particular histological, finding of the wound, such as the presence and / or proportion of tissue types or cell types, their quality or quantity, or the like.

[0096] In some embodiments, the system's computer unit has or uses algorithms for image processing and / or image comparison, in particular those based on artificial intelligence. In some embodiments, the computer unit is or comprises the at least one evaluation device mentioned herein, and the converse case, in which the at least one evaluation device is or includes the computer unit, is also encompassed by the present invention.

[0097] In some embodiments, the control device is the evaluation device mentioned herein, and / or vice versa.

[0098] In some embodiments, the mobile documentation device or system includes a user authentication function.

[0099] In some embodiments, the mobile documentation device or system includes a function for identifying or assigning the patient.

[0100] In some embodiments, the mobile documentation device or system includes the option of selecting the wound to be documented, in particular whether and, if so, optionally when the wound was previously documented. This is done in particular so that the images or models of one and the same wound obtained at different times can subsequently be correlated and compared. Thus, wound healing can be documented in detail.

[0101] In some embodiments, the mobile documentation device or the system includes an option for entering wound details (score, genesis, etc.) and / or wound treatment measures. Such inputs can refer to, for example, a classification of the wound, which can subsequently reduce the need for computing power. In this way, measures taken on the wound (e.g., dressings, medication, etc.) could be documented in detail and their effectiveness assessed. A measure that has proven effective can thus be stored, preferably in a retrievable manner, for example in the system's data memory, and then issued, for example, as a treatment recommendation, particularly for similar wounds in other patients.

[0102] The individual components of the system can be prepared or configured, in any combination, to be in signal communication with one another.

[0103] In some embodiments, a camera preview can be displayed on the GUI or elsewhere, which can be advantageously used to orient the user when positioning the mobile documentation device over the wound.

[0104] In some versions, a shutter button for taking a camera picture is implemented in the GUI.

[0105] In some embodiments, the captured image (e.g., from the main camera, or a 3D model, or the like) of the wound can be displayed on the GUI or elsewhere in the documentation device or system for review by the user. The user can then check the image, for example, for errors or blurriness.

[0106] In certain embodiments, this check can be performed or supported by the mobile documentation device or the system. For example, if the image quality of the recording is inadequate, which can be determined objectively or subjectively, such as through comparison or key figures, it may be planned to repeat the recording at this point. The user can receive appropriate information on this matter, supported by the mobile documentation device.

[0107] In some embodiments, the optional input of additional documentation parameters via the GUI may be provided. The documentation parameters are or include, for example, information on wound type, wound classification, undermining, wound odor, wound infection, wound pain, wound location, exudate, wound edge, wound perioperative area, comments on previous history, treatment, and diagnostics, and / or the like.

[0108] In some embodiments, the GUI can also be used to access the hardware elements to control or operate them. This can, in particular, enable one, several, or all of the following controls:

[0109] - Control of the individual camera modules (image recording and communication with the master board), for example, in order to trigger the existing cameras synchronously (in particular simultaneously, within a predetermined period of time or at predetermined intervals) and then store the captured images in the data memory

[0110] - Control of the main camera and the image parameters necessary for reproducible image recordings ( e . g . white balance, exposure, etc . )

[0111] - Scanning the distance sensors to determine and store a distance value

[0112] - Communication with the backend, i.e. for example with the system server, the data storage for recorded images, a cloud, etc. In some embodiments, the software of the mobile documentation device or the system for evaluating the recorded images by means of the documentation device includes algorithms and analysis techniques ("advanced analytics") based on artificial intelligence (AI), in particular radiomics, neural networks, mathematical functions and / or the like. These can include, among other things, evaluations of recorded images using statistical and / or learning methods.

[0113] The term "advanced analytics" can encompass the semi-automatic or automatic analysis of data. This involves the use of sophisticated, state-of-the-art methods and tools, e.g., regression, clustering, cohort analysis, recommendation algorithms, optimization, such as Bayesian optimization, gradient boosting (e.g., the XGBoost library), (decision) tree algorithms, preferably directed and / or non-cyclic, influence diagrams, graphical probability models, or the like.

[0114] In some embodiments, the term "advanced analytics" particularly encompasses methods that enable the derivation of models based on empirically collected data, which then enable assessments and predictions to be made.

[0115] Alternatively or in addition, various data mining methods can fall under the term “advanced analytics”. The term “data mining” includes semi-automatic or automatic

[0116] Evaluation of large amounts of data (e.g. from

[0117] patient collectives) to determine occurring regularities, laws and hidden connections, from which conclusions can be drawn about an expected development, here the

[0118] Wound healing, let it go. The term "data mining" can itself be encompassed by the broader process of knowledge discovery in databases (KDD).

[0119] In some embodiments, the "advanced analytics" include algorithms based on neural networks and / or machine learning, in particular "deep learning" and / or "reinforcement learning".

[0120] Neural network architectures may include convolutional neural networks (CNNs), long-short-term memory networks (LNS), recurrent neural networks (RNNs), or other types of neural networks commonly used for optimization or classification problems and known in the art.

[0121] In some embodiments, the computing unit is configured to assign a diagnostic and / or prognostic value to the input data in an optional additional evaluation step. The input data can be or include, for example, the results of an examination or diagnosis of the respective wound by the user or automatically, individual physiological patient data, systemic diseases such as diabetes mellitus and / or drug data relating to the previous treatment of the respective wound (medications, dressings, etc.). Alternatively, the computing unit is configured to assign a diagnostic and / or prognostic value to the input data as a whole, also in the evaluation step.

[0122] The diagnostic and / or prognostic value may be the probability of a particular outcome, for example, a time of complete healing of a wound, a time for a particular treatment procedure, a time at which deterioration of the patient's condition is to be expected, or the like. The value may be or include a risk assessment, an objective medical judgment, etc. Likewise, this value may, alternatively or additionally, indicate deterioration, an emergency, or the like.

[0123] For example, an image of a wound taken using a mobile documentation device can be awarded three out of five possible points. Five points would mean that the wound is in perfect condition, while zero points would mean that the wound, and in particular the condition of the blood vessels within the wound, is in the worst imaginable state.

[0124] Likewise, again for example, clinical staff can assess the wound with the naked eye and also assign a number of points (e.g., up to a maximum of five possible points). In some embodiments, it may also be possible to enter this score via the mobile documentation device, for example, via its display. Similarly, a corresponding value can be assigned to any other datum determined from the wound scan or by user input.

[0125] Alternatively, or in addition, a value can generally be assigned to an input. This value may be comprised of, or be derived from, an algorithm that considers multiple values ​​(one, for example, from the assessment of medical personnel, another, for example, from the analysis of the acquired image, etc.), or it may be obtained in another way, taking into account all available data.

[0126] In some embodiments, the software of the mobile documentation device or system includes, or the methods used include, binary segmentation, multiclass segmentation, and / or depth measurement. These can be used, for example, to distinguish between different tissue types in the wound area or to detect the progress of wound healing.

[0127] In some embodiments, the computer unit is part of the mobile documentation device; in others, it is part of the system, but not part of the mobile documentation device. The calculation or evaluation of the captured images and the information obtained therefrom can thus, in some embodiments, take place on the mobile documentation device; in others, it takes place elsewhere in the system.

[0128] An optional preprocessing of the recorded images or image data on the computer unit can result in the camera section actually including the image of a wound, preferably completely, or not.

[0129] An optional processing on the computer unit, for example an evaluation of the recorded images or image data, for example by AI, can be or include a classification of the wound based on scores, previous images, histological observations, such as the qualitative and, if applicable, quantitative presence of predetermined tissue types such as fibrin, granulation tissue, necrotic tissue, etc. This classification can in some

[0130] Embodiments can, for example, provide information about the expected further course of wound healing and / or help assess the necessity of a treatment measure, for example the need for medication, wound care, surgery and / or the like.

[0131] Post-processing, which optionally runs on the computer unit, in turn uses the information obtained from the recorded image and / or the results of the data processing carried out up to that point, in particular by using mathematical algorithms, to generate results that can be used by the user (e.g. length of the wound, width, wound healing process, etc.) and / or treatment suggestions (e.g. medication, care, operation, etc.). These results, as well as all other results of the information and findings obtained by the computer unit, can be brought to the user’s attention, e.g. in words or graphics, in particular graphically, or in another way. The control device can be programmed to make these available by means of the output device, which can be a display, a printer and / or the like.Programming for issuing therapy recommendations via the mobile documentation device or the system is also provided in some embodiments.

[0132] In some embodiments, a recording module is, in the simplest case, a camera. In other embodiments, a recording module is a combination of mostly electronic components such as a camera, sensor, etc., in particular as disclosed herein. The combination can be provided on a carrier material such as a circuit board, a stencil, an insert, etc., which is why in such cases the term recording module can refer to the carrier material equipped with the components. The carrier material extends in a main extension plane. If two adjacent recording modules or their main extension planes are at an angle (other than 0°) to one another, this can refer, for example, to the center lines of their camera angles, which are then not parallel to one another, or to the main extension planes, which are then not parallel to one another.

[0133] In some embodiments, the mobile documentation device does not have a marking device for marking the skin. A marking device can be a device for leaving a mark on the skin even after images have been taken. Non-directional or temporary illumination of the wound or the skin surrounding it does not count as a marking here. However, the application of stamps, colors, grids, etc. does. Devices for applying markings, e.g. by spray, printing or the like, count as marking devices. In some embodiments, a control device of the mobile documentation device is not programmed to control such a marking device when using the mobile documentation device to take images or recordings.

[0134] In some embodiments, the center line of the camera angle is understood to be an optical axis.

[0135] In some embodiments, the housing of the mobile documentation device is in two parts. In some embodiments, it has one, or exactly one, continuous upper shell and one, or exactly one, continuous lower shell. This has proven advantageous for sealing the mobile documentation device against the ingress of liquids, e.g., during sterilization. The requirements for labyrinth seals, etc., can be lower.

[0136] In some embodiments, the mobile documentation device is not an oral scanner.

[0137] In some embodiments, the mobile documentation device does not have any colored light sources and / or any light sources of different light qualities.

[0138] In some embodiments, no sequences of images taken by the same camera are used for analysis, for creating a 3D model, etc.

[0139] Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and / or below.

[0140] Conventional documentation systems based on two-dimensional images do not allow for reliable documentation of wound progression or wound healing due to unavoidable measurement inaccuracies, especially in large lesions. These images are not suitable as the sole source of assessment. The significance of such images can vary depending on the lighting, angle, and position of the ruler.

[0141] One advantage of the present invention may be that, due to its compact, mobile design, it is quickly available at a site of use. In some embodiments, it is approximately the size of an iPad mini or a tablet. Due to its low weight, for example, less than 1.0 kg in some embodiments, it can be used directly during on-site patient examinations. This saves the patient a trip to an examination device. This facilitates outpatient examinations.

[0142] A further advantage of the invention may be that many critical wound parameters can be recorded simultaneously. Furthermore, a complete 3D model of the wound can be created from the recorded parameters. In certain embodiments, this model, using color tone, wound edge, moisture, and / or tissue type analysis, can document not only the size or extent (area / depth) of the wound, but also data on vitality, blood flow, inflammation, wound healing, and / or the like. This can help the treating physician to arrange for the correct wound care.

[0143] Using the present invention, a patient's wound can be recorded and examined within a very short space of time. This advantageously helps to save time and costs and also does not place unnecessary strain on the patient. A further advantage of the invention can be its user-friendliness. In certain embodiments, intuitive LEDs indicate the correct positioning, for example by glowing green, and the triggering process itself takes approximately 0.1 seconds in certain embodiments. After approximately 30 seconds, the results can be displayed both on the display built into the device and on the treating physician's computer, in some cases even sooner. Therapists under great time pressure can advantageously use the resulting free time, for example, for analysis and therapy planning.

[0144] The ability to disinfect the invention enables the use of the invention in clinical operation and may represent a further advantage .

[0145] Furthermore, the reliable, detailed recording of wound parameters can also be advantageous, even when the patient is moving. This can be particularly beneficial in the treatment of chronic wounds. Chronic wounds often occur as a concomitant symptom of other illnesses that make it impossible for the patient to remain still for a longer recording time, for example due to tremor. With the invention, all parameters are recorded simultaneously within 0.1 seconds and the quality of all images is always equally good, even if the patient is shaking during this time or the image is reproduced from a different camera angle.

[0146] Since the integrated software can automatically record the most important characteristics of the wound (such as diameter, depth, redness, blood flow status, vitality, temperature, inflammation, exudate and / or the presence of specific tissue types, particularly at the wound edge, such as swelling, potential necrosis, etc.) in a very short time, the present invention can also be easily used to observe the wound over time. Since medical standards require the documentation of chronic wounds at regular intervals, the present invention can also support the treating physician in this regard. In particular, the present invention can be helpful in the time-efficient and objective assessment of therapeutic success.

[0147] In addition, the invention can offer additional benefits, such as providing prognoses based on the temporal course of the healing process. In addition or alternatively, it can send warnings, for example, if there are indications of impending or developing complications, such as the development of an infection or reduced tissue perfusion. Such indications can, in turn, be used as a decision-making aid during treatment, for example, to determine when a physician should be involved in the treatment.

[0148] The present invention is described below purely by way of example with reference to the accompanying drawings. In the figures, identical reference numerals designate identical or similar components. The following applies:

[0149] Fig. 1 shows a mobile documentation device in an exemplary embodiment;

[0150] Fig. 2 shows the embodiment of Fig. 1 in a perspective view obliquely from above; Fig. 3a shows the mobile documentation device of Fig. 1 tilted upwards by 90° from the side;

[0151] Fig. 3b shows the mobile documentation device of Fig. 1 tilted 90° to the right from the side;

[0152] Fig. 3c shows the mobile documentation device of Fig. 1 tilted 90° to the left from the side;

[0153] Fig. 4 shows the mobile documentation device of the preceding figures with a view of the underside;

[0154] Fig. 5 shows an exemplary mask with an interior region; and

[0155] Fig. 6 shows a simplified schematic representation of an embodiment of a system according to the invention.

[0156] Fig. 1 shows a mobile documentation device 100 according to the invention in a first embodiment.

[0157] In the example of Fig. 1, the housing 150 can be seen, in which at least one receiving module 101 can be accommodated. The housing can, for example, have the dimensions 211.89 mm (width B) by 133.57 mm (length L); other dimensions are also included.

[0158] The recording module 101 can have at least a first

[0159] Camera 103 (not shown in Fig. 1, see Fig. 3a and Fig. 4), which may be a 3-dimensional camera, and at least one display 117. The display 117 may serve for data reproduction and / or for control and / or as a user interface for inputting control signals for controlling the mobile documentation device 100.

[0160] The display 117 of the mobile documentation device 100 can, for example, include or be a 5-inch, 6-inch, 7-inch, or 8-inch screen, or larger, or a size with any value between any two of the above inch values. For example, the width BD of the display 117 can be 160.9 mm and the height HD of the display 117 can be 96.00 mm; other dimensions are also included.

[0161] In some embodiments, the recording module 101 may comprise the evaluation device 115 (not shown in Fig. 1).

[0162] The housing 150 of the mobile documentation device 100 further comprises a left holding section 151 and a right holding section 153, which are provided and suitable for the user to hold the mobile documentation device 100. However, both the left holding section 151 and the right holding section 153 are optional.

[0163] In the example of Fig. 1, the left holding section 151 and the right holding section 153 are connected to the housing 150 or to each other by means of a central housing section 150m.

[0164] In the illustrated embodiment, the length L of the left holding section 151 and / or the right holding section 153 is optionally not longer than the width B of the mobile documentation device 100. The affected

[0165] Holding section 151, 153 thus advantageously does not protrude beyond the width B of the mobile documentation device 100.

[0166] The mobile documentation device 100 may have a power supply module, which is a battery or a rechargeable battery or the like, or may additionally or alternatively have the necessary connections to be connected to a voltage source, e.g. the mains voltage.

[0167] If rechargeable batteries are used, they can be charged using systems known from the prior art. Such charging stations can be provided, for example, as part of a set that is also encompassed by the present invention and already includes a mobile documentation device 100 according to the invention. The set can be part of the system according to the invention.

[0168] Fig. 2 shows the embodiment of the mobile documentation device 100 of Fig. 1 in a perspective view obliquely from above.

[0169] Reference is made to the explanations for Fig. 1. The exact design of the left holding section 151 and / or the right holding section 153 is explained in more detail in Fig. 18a.

[0170] Fig. 3a shows the mobile documentation device 100 of Fig. 1 tilted upwards by 90° from the side. In the side view of the example of Fig. 3a, it has, optionally and roughly simplified, the shape of a large tubular bone, a double T, or an "H" due to the protrusion of the left holding section 151 and / or the right holding section 153, optionally both upwards and downwards. This embodiment will be described in more detail below.

[0171] In some embodiments, the mobile documentation device 100 has a second camera 103a, which may be a two-dimensional (2D) camera. The first and second cameras can be arranged arbitrarily on the housing, in particular on its underside facing away from the user and / or on the left holding section 151 and / or on the right holding section 153, in particular on its inner sides 151i, 153i.

[0172] In some embodiments, the mobile documentation device 100 or its recording module 101 comprises at least one light source 105 for illuminating the skin lesion of interest (not shown in Fig. 3a). What is stated herein for the position(s) of the first and / or second cameras 103, 103a may also apply to the position(s) of the optional light source(s) 105.

[0173] The intensity and / or the orientation, or the dimensions of the light cone of the at least one light source 105 can be adjusted manually or automatically. A switch, or a push-button switch, of any desired configuration can be provided, e.g., operable by finger or thumb, e.g., on the left holding section 151 and / or the right holding section 153.

[0174] In some embodiments, the mobile documentation device 100 or its recording module 101 comprises at least one thermal imaging camera (not shown in Fig. 3a). What is stated herein for the position(s) of the first and second camera(s) 103, 103a and / or the light source(s) 105 may also apply to the position(s) of the thermal imaging camera(s).

[0175] In some embodiments, the recording module 101 of the mobile documentation device 100 has at least one sensor 111, in particular a temperature sensor, an IR sensor, a UV camera, and / or a color sensor (not shown in Fig. 3a). What is stated herein for the position(s) of the first and second camera(s) 103, 103a, the light source(s) 105, and / or the thermal imaging camera(s) may also apply to the position(s) of the sensor(s) 111.

[0176] In some embodiments, the mobile documentation device 100 further comprises at least one distance sensor 109. What is stated herein for the position(s) of the first and second camera(s) 103, 103a, the light source(s) 105, the thermal imaging camera(s), and / or the sensor(s) 111 may also apply to the position(s) of the distance sensor(s) 109.

[0177] Light sources as used herein may be sources of a visible light spectrum, alternatively or additionally sources of radiation in the UV / IR range.

[0178] It can be seen from the example in Fig. 3a that the left holding section 151 and / or the right holding section 153 can optionally be fixed, here by means of an optional upper

[0179] Projection 151o, 153o projects towards the user, for example over a surface, top side or plane facing the user during use, which closes off the display 117. This can be, for example, the glass surface of the display 117, its touchscreen surface, etc. Alternatively or additionally, the left holding section 151 and / or the right holding section 153 projects over the middle housing section 150m by means of an optional upper projection 151o, 153o, which connects the left holding section 151 to the right holding section 153 or to other sections of the housing 150. This projection of the left holding section 151 and / or the right holding section 153 by means of an upper projection 151o, 153o can in particular be 1.5 cm or more. It is used in particular to form a grip, or part thereof, for the user's hand.

[0180] It can be further seen from the example in Fig. 3a that the left holding section 151 and / or the right

[0181] Holding section 153 optionally projects away from the user by means of an optional lower overhang 151u, 153u, for example over a surface, lower surface, underside or plane facing away from the user during use, which closes off the housing 150 or the recording module 101 at the bottom. This can be, for example, a plane in which cameras, sensors or light sources are located, etc. Alternatively or additionally, the left holding section 151 and / or the right holding section 153 projects over the middle housing section 150m by means of a lower overhang 151u, 153u, which connects the left holding section 151 to the right holding section 153 or to other sections of the housing 150. This projection of the left holding section 151 and / or the right holding section 153 by means of a lower projection 151u, 153u can in particular be 1.5 cm or more.It is used in particular to form a grip, or part thereof, for the user's hand.

[0182] The left holding section 151 and / or the right holding section 153 can have a rechargeable battery or a battery as a power source for the mobile documentation device 100. Arranging a rechargeable battery or a battery in one or both of the optional holding sections 151, 153 can help save installation space or provide an additional power source for extended mobile use.

[0183] Furthermore, the left holding section 151 and / or the right holding section 153, in particular at its upper optional projection 151o, 153o and / or at its lower

[0184] Projection 151u, 153u may comprise at least one switching device (not shown) for the user to control the mobile documentation device 100, e.g. to trigger, start or stop a recording by means of at least one of the cameras 103, 103a, to vary a lighting intensity, etc.

[0185] Such a switching device for the user can be, for example, a soft key, a push button switch, a slide switch, a toggle switch or the like.

[0186] Such a switching device for the user can be arranged or provided on a top side, bottom side and / or inside side 151i, 153i of the left holding section 151 and / or the right holding section 153, in particular on its upper optional projection 151o, 153o and / or on its lower projection 151u, 153u. From the example in Fig. 3a it can further be seen that the upper projection 151o of the left holding section and the upper projection 153o of the right holding section are designed differently than the respective lower projections 151u, 153u, which leads to respective different distances B1, B2 between the upper projections 151o, 153o and the lower projections 151u and 153u.The lower projections 151u, 153u can be more prominent or occupy more volume than the corresponding upper projection 151o, 153o, which serves to form a shape of a handle with which the mobile documentation device 100 can be held well and securely, in particular with one hand.

[0187] Fig. 3b and Fig. 3c show the mobile documentation device 100 of Fig. 1 tilted 90° to the right and left, respectively, from the side.

[0188] It can be seen here that between the upper overhang 1510, 151u and / or at the lower overhang 151u, 153u of the left holding section 151 and / or the right holding section 153 there is in each case a middle section 151m, 153m which closes off the mobile documentation device 100 at its end assigned to the left holding section 151 and / or the right holding section 153, i.e. forms the respective left or right edge. H1 denotes the height of the middle section 151m and the height H2 the height of the mobile documentation device 100. H1 can be exemplary, e.g. In the present example, 31.28 mm, H2 51.38 mm, generally speaking between 15 mm and 40 mm for H1 and / or between 30 mm and 65 mm for H2. Fig. 4 shows the mobile documentation device 100 of the preceding figures with a view of its underside in an exemplary embodiment.

[0189] In the example of Fig. 4, the first camera 103, preferably a 3D camera, and the second camera 103a, preferably a 2D camera, are arranged on the underside of the mobile documentation device 100. An optional third camera 111, which may be, for example, an infrared, hyperspectral, and / or thermal imaging camera, is also provided on the underside. In some embodiments, this camera may also be configured as a sensor or replaced by one.

[0190] The cameras can optionally be triggered to take a picture by means of the evaluation device 115 by the user activating only one triggering device, such as a trigger button, or by the user performing only one gesture. Thus, in some embodiments, these recordings can be taken simultaneously or at least overlapping in time.

[0191] The number, mode of operation, and position of the cameras 103, 103a, and 111 are purely exemplary and not to be understood as limiting. Any other arrangement of one or more suitable cameras is also encompassed by the present invention.

[0192] A circular light source 105 is arranged around the cameras in order to illuminate the increasing area as completely as possible. The shape and position of the light source 105 are purely exemplary and should not be understood as limiting. Any other arrangement of one or more suitable light sources is also encompassed by the present invention.

[0193] The components 103, 103a, 105, 111 can be provided in any combination, for example as a camera with a light source, sensors with different or identical modes of operation, etc., in any order and / or arrangement, for example camera-sensor-camera or camera-sensor-sensor, etc., and / or in any number, as far as technically possible, in or on the mobile documentation device 100, preferably on its underside. This is also encompassed by the present invention.

[0194] In addition to the cameras 103, 103a, 111, sensors of various types of operation can also be arranged in the mobile documentation device 100, for example distance, IR, color and / or temperature sensors as already explained herein. The sensors can in some

[0195] Embodiments can be arranged next to or around the cameras 103, 103a, 111 in the mobile documentation device 100.

[0196] In the example of Fig. 4, the light source 105 is shown separately from the cameras 103, 103a, 111. In other

[0197] In some embodiments, the light source 105 can be integrated into at least one of the cameras 103, 103a, 111 and / or arranged in a ring around the lens of the corresponding camera 103, 103a, 111.

[0198] As can be further seen from the example in Fig. 4, the mobile documentation device 100 in each embodiment can be of a size in which it can be easily operated with two hands. A control device 113 and / or an evaluation device 115 are indicated purely by way of example within the housing 150 in the example in Fig. 4. The size and position of these devices are purely exemplary and should not be understood as limiting. In some embodiments, they can also be located outside the housing and have a signal connection with the mobile documentation device 100.

[0199] The evaluation device 115 can be configured and / or programmed to collect data and / or to process and / or compare images. Additionally, it can create three-dimensional models of wounds based on the data recorded or measured by the mobile documentation device or its components.

[0200] The evaluation device 115 can create a chronological documentation that reflects the course of the wound healing process. It can provide prognostic statements about this course and / or issue warnings if, for example, indications of a complication in the healing process are detected, such as indications of infection, impaired wound healing, tissue hypoxia, etc.

[0201] In further embodiments, the evaluation device 115 can preferably be additionally configured to control cameras / sensors 103, 103a, 109, 111, light sources 105 and / or, in some embodiments, control devices 113 of the mobile

[0202] Documentation device 100 to control. Fig. 5 shows an exemplary mask 190 with an inner region I. The pixels of the inner region I have the pixel value 0 or white, all others have the pixel value 1 or black. The edge of the mask 190 can be the outermost row of white pixels or the innermost row of black pixels. The shape of the inner region I corresponds to the area identified as the wound area in the 2D image.

[0203] Fig. 6 shows a simplified schematic view of a system according to the invention in one embodiment with a mobile documentation device 100, a data memory 170 for storing images or image data of wounds of one or more patients, a computer unit 180 for processing images or image data taken by means of the mobile documentation device 100, and with an output device 119.

[0204]

[0205] 100 mobile documentation devices

[0206] 101 Recording module with integrated evaluation device, main module

[0207] 103 first camera

[0208] 103a second camera

[0209] 105 Light source

[0210] 109 Sensor (distance)

[0211] 111 third camera or sensor (temperature, IR or color sensor)

[0212] 113 Control device

[0213] 115 Evaluation device

[0214] 117 Display, User Interface (GUI),

[0215] touchscreen

[0216] 119 Dispensing device

[0217] 150 housings

[0218] 150m middle housing section

[0219] 151 left stopping section

[0220] 1510 upper overhang

[0221] 151m middle housing section of the left

[0222] stopping section

[0223] 151u lower overhang

[0224] 1511 Inside of the lower left overhang

[0225] 153 right stopping section

[0226] 1530 upper overhang

[0227] 153m middle housing section of the right

[0228] stopping section

[0229] 153u lower overhang

[0230] 1531 Inside of the lower right overhang

[0231] 170 Data storage 180 Computer unit

[0232] 190 Mask

[0233] B Width of the housing

[0234] BD Width of the display

[0235] Bl Distance between the upper projections

[0236] B2 Distance between the lower projections

[0237] Hl Height of the middle section

[0238] H2 Height of the mobile documentation device

[0239] HD display height

[0240] I Inside the mask

[0241] L Length of the housing

Claims

Claims 1. A mobile documentation device (100) for data acquisition of skin lesions, for example wounds, comprising: a housing (150); precisely or at least one recording module (101) accommodated in the housing (150) or a part thereof, which comprises: at least one first camera (103); and at least one display (117) for data reproduction and / or for control and / or as a user interface for inputting control signals for controlling the mobile documentation device (100).

2. Mobile documentation device (100) according to claim 1, wherein the first camera (103) is a 3-dimensional (3D) camera.

3. Mobile documentation device (100) according to one of the preceding claims, wherein the mobile documentation device (100) has a second Camera (103a) which is a 2-dimensional (2D) camera.

4. Mobile documentation device (100) according to one of the preceding claims comprising or connected to at least one evaluation device (115), configured for collecting data and / or for image processing and comparison in order to create three-dimensional image models or models of wounds based on the data which were recorded or measured by the mobile documentation device (100), in particular configured to control the cameras (103, 103a), sensors (109, 111), light sources (105) and / or control devices (113) of the mobile documentation device (100).

5. Mobile documentation device (100) according to claim 4, wherein the recording module (101) comprises the evaluation device (115).

6. Mobile documentation device (100) according to one of the two preceding claims, wherein the evaluation device (115) or the recording module (101) or its control is programmed to determine a depth of the wound or lesion to be documented based on data from the first camera (103) and to forward the result of this determination, e.g., to have it displayed on the display (117).

7. Mobile documentation device (100) according to one of claims 4 to 6, wherein the evaluation device (115) is physically separate from other components of the mobile documentation device (100), is in wireless signal connection with at least one of these or is prepared for this purpose and / or remotely controls them.

8. Mobile documentation device (100) according to one of the preceding claims, wherein the mobile documentation device (100) is sterilizable.

9. Mobile documentation device (100) according to one of claims 4 to 8, wherein the evaluation device (115) or another device, e.g. the control device (113), is programmed to initiate both a 3D recording by means of the first camera (103) and a 2D recording by means of the second camera (103a).

10. Mobile documentation device (100) according to the preceding claim, wherein the evaluation device (115) or another device, e.g. the control device (113), is programmed to initiate both recordings after the user has actuated only one triggering device, such as only one trigger button, or when the user performs only one gesture.

11. Mobile documentation device (100) according to one of the two preceding claims, wherein the evaluation device (115) or another device, e.g., the control device (113), is programmed to cause both images to be taken simultaneously or at least with an overlap in time by actuating the triggering device.

12. Mobile documentation device (100) according to one of claims 4 to 11, wherein the evaluation device (115) or another device, e.g., the control device (113), is programmed to Determining a mask (190) from the 2D image which corresponds to the wound in the 2D image or is or will be assigned, wherein the mask (190) has an inner region (I).

13. Mobile documentation device (100) according to claim 12, wherein the evaluation device (115) is programmed to - defining a region of the 3D image which is assigned to the inner region (I) of the mask (190) after, or by means of, projection of the mask (190) onto the 3D image, or to an edge or circumferentially closed edge of a region.

14. Mobile documentation device (100) according to claim 13, wherein the evaluation device (115) or another device, e.g., the control device (113), is programmed to - Extract the specified area, or the edge thereof, of the 3D image from the 3D image.

15. Mobile documentation device (100) according to claim 13 or 14, wherein the evaluation device (115) or another device, e.g., the control device (113), is programmed to - Evaluate the extracted area.

16. Mobile documentation device (100) according to claim 15, wherein the evaluation is or comprises: Defining a plane in the 3D image that encompasses the specified edge, or at least three pixels that lie on or near the edge.

17. Mobile documentation device (100) according to one of claims 15 to 16, wherein the evaluation is or comprises: - Determining the distances from a plurality of pixels of the 3D image to the plane encompassing the edge.

18. Mobile documentation device (100) according to one of claims 15 to 17, wherein the evaluation is or comprises: - Determine the surface area of ​​the wound bed underneath the surface using the determined distances.

19. Mobile documentation device (100) according to one of claims 15 to 18, wherein the evaluation is or comprises: - Measuring the extracted area.

20. Mobile documentation device (100) according to one of the preceding claims, wherein the mobile documentation device (100) has at least one light source (105) for illuminating the skin lesion.

21. Mobile documentation device (100) according to one of the preceding claims, wherein the mobile Documentation device (100) or its Recording module (101) has at least one thermal imaging camera.

22. Mobile documentation device (100) according to one of the preceding claims, wherein the recording module (101) further comprises at least one sensor (111), in particular a temperature sensor, a UV camera, an IR sensor and / or a color sensor.

23. Mobile documentation device (100) according to one of the preceding claims, further comprising at least one distance sensor (109).

24. Mobile documentation device (100) according to one of the preceding claims, wherein the housing (150) has a left holding section (151) and / or a right holding section (153) for holding the mobile documentation device (100) by the user.

25. Mobile documentation device (100) according to claim 8, wherein the left holding section (151) and / or the right holding section (153) has a rechargeable battery or a battery as a voltage source for the mobile documentation device (100).

26. Mobile documentation device (100) according to one of claims 24 to 25, wherein the left holding section (151) and / or the right holding section (153) is / are projecting by means of a lower projection (151u, 153u) over a surface or plane facing away from the user during use and terminating at least one of the cameras (103, 103a) in the direction of User away, or over one, the left Holding section (151) with the right holding section (153) or with further sections of the housing (150) connecting the housing section (150m), in particular by 1.5 cm or more.

27. Mobile documentation device (100) according to one of claims 24 to 26, wherein the left holding section (151) and / or the right holding section (153), in particular on its upper projection (151o, 153o) and / or on its lower projection (151u, 153u), have at least one switching device for the user to control the mobile documentation device (100), e.g. for triggering, starting or stopping a recording by means of at least one of the cameras (103, 103a).

28. Mobile documentation device (100) according to claim 27, wherein the switching device for the user can be a soft key, a push switch, a slide switch, a toggle switch or the like.

29. Mobile documentation device (100) according to one of claims 24 to 28, wherein the switching device for the user on a top side, bottom side and / or inside side (151i, 153i) of the left holding section (151) and / or the right holding section (153), in particular on its upper projection (151o, 151o) and / or on its lower projection (151u, 153u) have at least one switching device for the user for controlling the mobile documentation device (100), e.g. for triggering, starting or stopping a recording by means of at least one of the cameras (103, 103a).

30. Mobile documentation device (100) according to one of claims 24 to 29, wherein the left holding section (151) and / or the right holding section (153) are each no longer than the width of the mobile documentation device (100).

31. Mobile documentation device (100) according to one of claims 24 to 30, wherein between the upper projection (1510, 151u) and / or at the lower projection (151u, 153u) of the left holding section (151) and / or the right holding section (153) there is a middle section (151m, 153m) which closes off the mobile documentation device (100) to its end associated with the left holding section (151) and / or the right holding section (153).

32. Mobile documentation device (100) according to one of the preceding claims, wherein the display (117) is or comprises a 5-inch, a 6-inch, a 7-inch or an 8-inch screen.

33. Mobile documentation device (100) according to one of the preceding claims, wherein the intensity and / or the orientation, or the dimensions of the light cone of the light source (105) are manually or automatically adjustable.

34. System comprising: a mobile documentation device (100) according to one of claims 1 to 33; a data memory (170) for storing in particular images or image data of wounds of one or more patients; - a computer unit (180) for processing images or image data taken by means of the mobile documentation device (100); - an output device (119), wherein a device of the system, e.g. the control device (113), is programmed to output information concerning the recorded images.

35. The system of claim 34, wherein the output information is or includes information about at least one dimension of the wound.

36. System according to claim 34 or 35, wherein the information is or contains details about at least one, in particular histological, finding of the wound.

37. System according to one of claims 34 to 36, wherein the computer unit has or uses algorithms for image processing and / or image comparison, in particular those based on artificial intelligence.

38. A method for mobile detection of skin lesions, for example wounds, which comprises using a documentation device (100) according to one of claims 1 to 33 and / or using a system according to one of claims 34 to 37.