Methods for non-invasive capture of the temporal evolution of the state of tissue structures - Patents.com

Abstract

In the method for non-invasive capture of the temporal evolution of the state of tissue structures, first measurement data of a body region (1) are non-invasively recorded and first image data are generated from the recorded measurement data. This first image data is pre-processed locally with the aid of a first local terminal device (100.1) and transmitted together with first identification data from the first local terminal device (100.1) to a server (10) for storage. The stored image data is then retrieved from the server (10) using the second identification data and displayed on a second local terminal device (100.2). This is followed by non-invasive recording of second measurement data of the body region (1) and second image data is generated.

Description

[Technical field]

[0001] The present invention relates to a method for the non-invasive capture of the temporal evolution of the state of tissue structures.The invention further relates to a system and a computer program for carrying out said method. [Background technology]

[0002] In the context of medical diagnostics, it is often useful to track the evolution of the state of tissue structures over time in order to obtain basic information for the diagnosis and to ensure that therapeutic measures are taken in a timely manner while avoiding unnecessary measures.

[0003] For example, in the case of possible acute compartment syndrome (often called Loge syndrome), one or more compartments in question should be monitored after a traumatic impact. For this purpose, a series of examinations are performed at intervals of several hours. The results of each examination and their evolution over time are used as the basis for the diagnosis and for the decision regarding surgical treatment. Various techniques for the examination are known. The simplest is manual palpation to capture the elastic properties of the compartment. Here, the examining physician mainly relies on his own experience, which means that different experts reach different conclusions. Greater reliability can be achieved by pressure measurements directly in the compartment, but these examinations are invasive and therefore painful and generally involve a risk of infection.

[0004] Therefore, in WO 2019 / 106535 (U. Baumann, V. Baumann), inter alia, a combination of a pressure measuring device with an ultrasound measuring unit was proposed in order to systematically and non-invasively capture the elastic properties of the compartments. Such a combination is also suitable for obtaining basic information for the diagnosis of compartment syndrome.

[0005] When examinations of tissue structures are performed at different times by different specialists, there is a risk that different examination modalities, e.g. examination locations or corresponding parameters, may differ and lead to different results. This makes it particularly difficult to compare several examination results on the same tissue structure, e.g. to obtain trend information. Particularly in non-invasive examinations, e.g. examinations performed using handheld devices, systematic differences in positioning may occur. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2019 / 106535 Summary of the Invention [Problem to be solved by the invention]

[0007] The object of the present invention is therefore to create a method belonging to the initially mentioned technical field for non-invasive capture of the temporal evolution of the state of tissue structures, which provides improved basic information for diagnostic purposes based on several time-offset examinations. [Means for solving the problem]

[0008] The solution to the problem is defined by the features of claim 1. According to the invention, a method for non-invasive capture of the time evolution of the state of tissue structures comprises: a. non-invasively recording first measurement data of a body area to be examined and generating first image data from the recorded measurement data; b. local pre-processing of the first image data using a first local terminal device; c. transmitting the pre-processed first image data and the first identification data from the first local terminal device to a server for storage; d. At a later point in time, retrieving the stored image data from the server with a second local terminal device using the second identification data; e. displaying the retrieved image data on a second local terminal device; f. non-invasively recording second measurement data of the body region to generate second image data; Includes.

[0009] This procedure is particularly suitable for humans, but may also be used in veterinary medicine.

[0010] Non-invasive capture or non-invasive recording of measurement data includes steps that are performed without incision and without inserting a device or catheter into the body, i.e. purely externally. In particular, this includes measurements that are performed outside the body or using appropriate fields or radiation (e.g. sonography, X-ray examination, MRI, OCT, etc.).

[0011] The identification information is, for example, a number or an alphanumeric string, but can also be, for example, image data. Preferably, the identification data does not allow any conclusions to be drawn about the patient's identity (e.g., name, insurance number or the like). In this way, particularly sensitive patient information can be protected and the assignment can only be made locally and not based on data transmitted or stored by a server.

[0012] The first and second image data are in particular cross-sectional images, for example in a plane that is at an angle of 60° to 120° with respect to a tangent plane to the body surface at the measurement location. However, three-dimensional images can also be generated as the first and second image data. The first and second image data can each include one or more images.

[0013] During the local pre-processing of the first and second image data, in particular filters are applied to the image data, for example to enhance contrast, reduce image noise or enhance contours. For example, the well-known HAF filter (Histogram Adaptive Fuzzy Filter) can be used. Also, image sections can be automatically selected. Additional information, for example intensity curves and / or histograms, can be obtained from the image data during pre-processing. The image data can also be compressed, for example. Depending on the criteria with which the first image data was obtained and the format in which it is available, more or fewer steps are required during pre-processing.

[0014] The transmission of the preprocessed first image data and the first identification data from the first local terminal device to the server can be done directly via a data network to which both the first local terminal device and the server are connected, or a gateway is used that is local to the first local terminal device, with which the first local terminal device communicates and which takes over the data transmission between the servers for all local terminal devices. In particular, the data is transmitted via a secure Internet connection (for example using Transport Layer Security (TLS)). For example, the local terminal device is wirelessly connected to the router via a (also protected) WLAN connection. However, transmission via a mobile network is also possible, for example. If a gateway is used, the data to be transmitted can be temporarily stored locally. However, since the image data is not necessarily retrieved later using the same terminal device, and since a different gateway may also be used (for example if the patient moves to another department or hospital), the data should be transmitted to the server within a maximum time period so that it can be retrieved at a later point in time.

[0015] Local intermediate storage may also take place on the first local terminal device itself, especially if transmission to a gateway or server is temporarily not possible. In some cases, for example if the connection is interrupted for a longer period of time, data required for the second and subsequent measurements (e.g. the first image data) may be used from the local cache, provided that the same local terminal device is used again.

[0016] The pre-processed first image data, or further processed image data obtained therefrom, is linked to the first identification data after storage.

[0017] The first local terminal device and the second local terminal device can be two devices or the same device, depending for example on whether the patient is examined at the same location and / or by the same person during examinations at different times. The data storage in the server ensures that the second measurement data can be obtained accurately and reliably in the same way in both cases. The same applies to any other local terminal devices used to examine the patient over time.

[0018] If the first and second identification data are unique numeric or alphanumeric data, this data can be used to directly retrieve the stored image data. If the information is of a different type, for example image data, the first and second identification data are generally not identical. In this case, a comparison operation is performed on the server to assign the first identification data to the second identification data. The stored image data can be preprocessed first image data previously transmitted by the first local terminal device, or image data further processed on the server. In addition to the image data, further information linked to the first identification data can be retrieved.

[0019] The display of the retrieved image data on the second local terminal device facilitates the acquisition of the second measurement data in that the user can easily ensure using this image data to perform the second examination at the same examination site and with the same examination parameters, for example with regard to the orientation of the cross sections, regardless of whether the user performed the first examination himself or herself. This image data can thus serve as a navigation aid during the second examination to ensure that the same tissue structures are examined and the same image sections are generated. In addition to the image data, further information can be stored in the server and retrieved by the second terminal device to ensure reproducibility of the measurements, for example distance information regarding the body surface, photographs of the measurement site and / or video sequences documenting the measurement process during the first examination.

[0020] Thus, the same local terminal device and devices integrated therein or connected thereto, i.e. devices for recording measurement data, can be used to carry out successive examinations on the same patient or on different patients, whereby the correct assignment of image data and measurement data is always guaranteed.

[0021] This method is particularly advantageous for series of examinations, which include several examinations of the same type of the same body area, spaced apart by minutes to hours.The method is also particularly advantageous for examinations performed using handheld devices, since in these cases it can be particularly difficult to guarantee the same framework conditions for several alternating examinations without imaging support.

[0022] The method according to the invention is not limited to performing two measurements, but three or more measurements may be performed in the same manner, at respective time intervals, on the same two or more local terminal devices.

[0023] Preferably, when the second measurement data is recorded, the second image data is displayed on the second local terminal device in real time, in particular simultaneously with the retrieved image data.

[0024] This allows a particularly precise monitoring of the recording of the second measurement data and in particular an increased visual accuracy during the measurement process. This increases the inter- and intra-observer reliability of the procedure. For example, the operator can immediately recognize whether essentially the same tissue structures are being examined in the same image sections. In general, deviations in the examination parameters can also be easily recognized on the basis of the generated and displayed images. Due to the real-time display, adjustments made by the operator have immediate effect, resulting in an intuitive and smooth operation.

[0025] In a preferred embodiment of the method according to the invention, the non-invasive recording of the first measurement data comprises a sonographic measurement process.

[0026] Such measurements can be performed on virtually all patients, including fetuses, without any anticipated adverse consequences. Such measurements are suitable for examining a variety of tissue structures, including sensitive ones, and can be performed using relatively inexpensive techniques and compact devices. Furthermore, serial repeat imaging can be easily performed, which allows for individualized, risk-based, and reliable monitoring of the examination process.

[0027] Instead of or in addition to sonographic measurements, other measurement procedures may be performed that can provide measurement data suitable for obtaining image data of the tissue structure to be examined, including, for example, X-ray examination (CT), magnetic resonance imaging (MRI), optical coherence tomography (OCT), etc.

[0028] Advantageously, the pre-processed first image data can be displayed on a local terminal device and further first measurement data can be recorded based on the display.

[0029] If the other first measurement data are based on a different measurement principle, the display of the image data allows in particular a precise positioning of the corresponding measuring device. It is particularly preferred that the image data is displayed in quasi-real time, as is easily possible, for example, on the basis of sonography.

[0030] The first image data may be pre-processed for display on the local terminal device in the same or different manner and for transmission to the server. It is also possible to generate differently pre-processed image data and transmit both to the server for storage. For example, the first pre-processed image data may be later retrieved and displayed on a second local terminal device, and the second pre-processed image data may be stored on the server for reference or diagnostic purposes and is not required for recording the second measurement data.

[0031] The non-invasive recording of the first measurement data may in particular include a measurement of the contact pressure.

[0032] The value of the contact force is another first measurement data mentioned above. For example, the contact force exerted essentially perpendicular to the body surface can be used to determine the elastic properties of the tissue structure under investigation.

[0033] Other measurement data may also be acquired and linked to the first measurement data used to acquire the image data, including, for example, information regarding heart rate, blood pressure, blood oxygen saturation, body temperature, etc., possibly related to the location of the respective examination.

[0034] To obtain information regarding the elastic state of the tissue structure, dimensions may be determined in both the first image data and the second image data, each involving at least two different contact pressure forces.

[0035] Depending on the purpose of application and the available image data, the dimension can be a point position, a length, an area or a volume. Ratio sizes are also possible, for example corresponding to the eccentricity of an ellipsoid, or the ratio of the lengths of two parallel lines or lines at a particular angle.

[0036] By comparing the dimensions obtained from different contact forces, a direct measure of the elasticity (or stiffness) of the tissue structure under investigation can be obtained. For example, strong compression of a tissue structure by the application of a force usually means that the tissue structure has a high overall elasticity, while low compression indicates low elasticity (or high stiffness). If the tissue structure includes compartments, low elasticity can indicate high internal pressures in particular within these compartments. In this context, a compartment is understood to be a closed cavity or containment space within the body, where a certain pressure prevails, which may be fundamentally different from the pressure in the surrounding tissue. Of interest here are compartments that can be elastically deformed by the application of an external force. Such compartments include, in particular, muscle tissue, blood vessels and compartments of organs (e.g., liver or brain).

[0037] A manual marking process may be performed on the displayed first and second image data to determine the dimensions.

[0038] During the manual marking process, the operator, in particular via a user interface of the first local terminal device and / or the second local terminal device, defines one or more points, lines, areas and / or volumes in the displayed image data, which results, either directly or by arithmetic operations, in length, area or volume values, or other geometric values ​​such as angles or eccentricities.

[0039] To support the manual marking process, a representation of an intensity curve of the first image data or the second image data along the line is displayed.

[0040] Such a representation has been shown to be particularly useful when defining a position, or a distance determined by two positions, since it improves the reproducibility of the marking process. The intensity curve itself can be displayed, which is often advantageous if this is smoothed by an appropriate algorithm, for example a binning process.

[0041] Advantageously, suggestions for markings to be made during the marking process are automatically generated based on the first image data or the second image data.

[0042] The proposal serves as a starting point for manual marking by the operator, thus facilitating the marking process. Nevertheless, the responsibility for marking still rests entirely with the operator.

[0043] The proposal is generated with the aid of common image processing methods, in particular for example recognizing edges, but it can also be based on (supervised) machine learning processes, for example with the aid of artificial neural networks, whereby previous markings and corresponding image data made by the same or other operators serve as training data for training and improving the model.

[0044] The dimensions may also be determined automatically based on the first image data or the second image data.

[0045] The determination of the dimensions, like the generation of the suggestions, can in particular be based on general image processing methods and / or machine learning processes. It is also possible to initially provide a manual marking process in the overall system for carrying out the method according to the invention, and to enable an automatic decision for a particular measurement process only when the adjustments made by the operator to the automatically generated suggestions are statistically below a predefined level.

[0046] The location of the measurement to be performed can be determined by the operator, for example by a corresponding marking process on the image data, but can also be determined automatically. In a preferred embodiment, the location is specified by the operator during the first measurement and then determined automatically during the subsequent measurement using the image information, for example by aligning the latest image data with the first image data using an alignment process and transferring the location of the measurement from the first image data to the latest image data. Thus, especially in the case of subsequent measurements, the measurement and any subsequent steps can be performed fully automatically as soon as the corresponding measurement data can be recorded, for example as soon as the measuring head of the measuring unit is appropriately positioned. This positioning can be supported by the system, for example by displaying the measurement location for the measuring head with the aid of markings projected on the body surface or with the aid of augmented reality techniques.

[0047] In a preferred embodiment, a first value for the elastic state of the tissue structure is determined from the determined dimensions at different contact forces based on the first measurement data, and a second value for the elastic state of the tissue structure is determined from the determined dimensions at different contact forces based on the second measurement data, the first value and the second value representing measures of the deformability of the tissue structure.

[0048] The value for the elastic state of the tissue structure may be a value that is a measure of the elasticity of the examined tissue or a value that is a measure of the stiffness of the examined tissue.

[0049] It is particularly preferred to use an ultrasonic measuring head with an integrated pressure measuring device, such as that known from EP 3716842 (Veinpress GmbH), to simultaneously generate and display an image of the tissue structure to be examined and to measure the applied contact pressure corresponding to a certain contact pressure. As soon as the required pressure is generated, the dimensions can be determined on the basis of the image. In the case of manual marking, this can be supported by immediately generating a still image of the current ultrasonic image when a predefined pressure value is reached and displaying it for the subsequent marking process. If the dimensions are determined automatically, the image at the corresponding pressure value can be used directly as a reference.

[0050] The generation or automatic evaluation of the still images can be repeated for several predefined pressure values. In this case, the operator only has to position the measuring head at a point corresponding to the tissue structure to be examined, slowly increase the contact pressure manually, for example for a few seconds, and then reduce the contact pressure again. The still images generated at the specified pressure values ​​are then displayed and the dimensions can be determined.

[0051] One possible definition of a value for the elastic state of a tissue structure is the so-called "CP score", defined as follows:

number

[0052] A CP score of 0% corresponds to (theoretical) complete compression along the stated line, i.e. high elasticity (or low stiffness). A CP score of 100% corresponds to no compression along the stated line, i.e. low elasticity (or no elasticity) (or maximum stiffness).

[0053] In principle, a comparison between the compressed and uncompressed (i.e., no contact pressure) state would be of interest, but here a lower, lower pressure is suggested, since a certain minimum pressure of the ultrasound probe on the body surface is required to obtain a usable ultrasound image.

[0054] The CP scores at different time points provide valuable basic information for the diagnosis of compartment syndrome. Their absolute values ​​can be compared with thresholds and / or the time course, especially the time gradient of the CP score, can be taken into account to draw conclusions. The definition as a ratio allows systematic errors to be excluded from the outset.

[0055] For example, modified CP scores are possible to characterize other tissue structures whose dimensions are determined at other specified pressure values. The scale can also be generalized to take into account measurements at more than two pressure values.

[0056] The method according to the invention can in particular be used to obtain information about the elastic state of a compartment. Such information is of great value with regard to the detection of signs of diseases related to the compartment. In particular, the method can provide basic information for the diagnosis of compartment syndrome (or Rowe's syndrome). In addition to information about the elastic state, including in particular the above-mentioned values ​​about the elastic state of the tissue structure, other measurement data can also be collected and processed, for example about the blood oxygen content in the area of ​​the examined tissue structure.

[0057] The body areas to be examined are therefore those in which compartment syndrome may occur, for example. This includes the forearm and leg areas as well as the abdomen. However, the procedure may also be used in other areas of the body at risk and in conjunction with other clinical pictures.

[0058] Preferably, the time information is transmitted to a server for storage together with the pre-processed first image data and the first identification data.

[0059] The time information is linked to the image data and the identification data on the server. In addition to the mentioned information, further data, for example measurement parameters or identification data related to the person taking the measurement, may be transmitted to the server for storage.

[0060] Preferably, medically relevant time points, especially times of traumatic impacts, are captured and transmitted to a server for storage.

[0061] If information is known about the typical course of symptoms caused by a traumatic impact, such as acute compartment syndrome, it can be extremely informative if the time of the traumatic impact is known and included in the diagnostic assessment. The time of the traumatic impact is therefore an important additional basic information for the subsequent diagnosis.

[0062] If measurement data is already available, it can be compared with a typical course, taking into account the captured time of the traumatic impact, which can be used, for example, to generate corresponding improved measures for characterizing the state of tissue structures.

[0063] In the case of an impending but not yet diagnosed acute compartment syndrome, consideration of the traumatic impact may allow for more certain or earlier recognition of the progression or innocuous course leading to acute compartment syndrome. In the case of chronic compartment syndrome, the first time pain occurs during sporting activities or as part of a standard testing protocol may be equated with the traumatic impact for the purposes of analysis.

[0064] A recommendation may also be generated as to when to capture the second measurement data, taking into account the medically relevant time points captured.

[0065] For example, in the typical course of a disease, there are time periods when a thorough examination is indicated, while in other periods frequent examinations would provide little insight. Thus, the generated recommendations can be used to ensure that necessary information is captured early on while avoiding unnecessary effort and unnecessary stress for the patient.

[0066] Preferably, the body area to be examined is provided with an individual marking before the first measurement data are recorded, this marking is read by a first reading device and the first identification data is generated on the basis of the read marking, before the stored image data is retrieved the marking is read again using a second reading device and the second identification data is generated using the read marking.

[0067] The marking ensures the correct assignment of several measurement data recorded at different times to the same patient or to the same body area. It can generally specify the body area to be examined, for example a limb. In this case, the subsequent examination is based on further information, for example physiological information. However, the marking can also be placed directly at the site of the examination to be performed, so that the site to be examined is immediately identified.

[0068] The markings may be universally unique, for example by including a centrally assigned unique identification number, but sufficiently statistically unique so that individual patients or body parts to be examined at a treatment location (e.g., hospital) can be distinguished with near certainty, with further information available if necessary.

[0069] The identification information, for example a number or an alphanumeric string, in particular corresponds to the content or part of the content of the marking, although depending on the marking it can also be, for example, image data.

[0070] The first reading device and the second reading device may be two devices or the same device, depending, for example, on whether the patient is tested at the same location and / or by the same person during spaced tests.

[0071] Thus, a particular patient may be examined several times with the same or different instruments based on the individual markings without the need for an operator to make a manual assignment.

[0072] Preferably, a tag having a unique identification is attached, in particular affixed, to the body area to be examined for individual marking.

[0073] In particular, the tag may contain optically readable information (eg, a bar code or dot matrix code) and / or electrically readable information (eg, using RFID technology).

[0074] As an alternative to such tags, it is also possible to mark the body area using, for example, a stamp or a "random" felt-tip pen pattern. Multiple identifications can also be made using the patient's face (facial recognition), or possibly an optical image of the body area itself, but this raises questions regarding the anonymization of the data. It is also possible to use other biometric features of the patient (e.g. fingerprints).

[0075] Preferably, the first reading device and the second reading device are optical reading devices, in particular cameras.

[0076] The reading device may be integrated into a measurement head, e.g. an ultrasound head, for recording the first or second measurement data. However, the reading device may also be integrated into the first or local terminal device or may be a stand-alone device. For capturing standardized codes, e.g. bar codes or dot matrix codes, a dedicated reading device may be used instead of a camera.

[0077] In a further embodiment, the first and second reading devices comprise transponders for interacting with RFID transponders in the corresponding tags, in which case the reading devices are particularly easy to integrate into the measuring head.

[0078] In principle, the reading device can also be a keyboard or a touch screen. If the individual marking contains, in addition to the machine-readable information, in particular optically directly detectable information such as numbers or character strings, this can be read and entered by an operator. Nevertheless, the presence of machine-readable information is advantageous, since it minimizes the risk of errors.

[0079] Instead of being based on an individual marking on the body area to be examined, the identification data may also be obtained from other information or documents, for example, by reading or entering information on a wristband, a label attached to another body area, or on a patient file or patient sheet.

[0080] A system for carrying out the method according to the invention comprises: a. a measuring device for non-invasive recording of measurement data of the body area to be examined during the measurement process; b. at least one local terminal device having a display device; c. A server for storing and forwarding the received data; and thereby at least one local terminal device and a server are set up for mutual exchange of data; at least one local terminal device is set up to receive measurement data from the measurement device and to generate and display image data from the received measurement data; at least one local terminal device is set up to transmit identification data and image data to a server; - at least one local terminal device is set up to retrieve stored image data from the server based on the identification data transmitted to the server and to display said retrieved image data during the measurement process.

[0081] When examining a patient, the same terminal device can always be used over time, or different devices can be used, each of which can generate first and second measurement data as needed. Preferably, the identification data is used to automatically recognize whether stored image data is already available and whether it should be retrieved and displayed. For example, the identification data is always sent to a server, which then returns either the stored image data and / or information about the presence of previous measurements or image data.

[0082] A preferred embodiment of the system according to the invention further comprises at least one reading device for reading individual markings on the body area to be examined and generating corresponding marking data, and at least one local terminal device is set up to receive the marking data from the reading device and to generate the identification data from this marking data.

[0083] Again, the same reading device may always be used over time, or different devices may be used.

[0084] A computer program suitable for controlling a local terminal device of a system according to the invention is provided which, when executed by a computer, causes the computer to: a. receiving first measurement data from a measurement device, generating first image data from the received first measurement data, and displaying the first image data on a display device; b. transmitting the identification data and the first image data to a server; c. sending the second identification data to the server; d. receiving the stored image data from the server using the transmitted second identification data; e. displaying the received image data on a display device; f. receiving second measurement data from the measurement device, generating second image data from the received second measurement data, and displaying the second image data on the display device; The instruction to execute the command is included.

[0085] In a preferred variant, the computer program comprises: - receiving first marking data from a reading device and generating first identification data from the first marking data; - receiving second marking data from the reading device and generating second identification data from the second marking data; The method further includes instructions for executing the method.

[0086] Further advantageous embodiments and feature combinations of the invention emerge from the entirety of the following detailed description and the claims.

[0087] The drawings used to illustrate example embodiments show: [Brief description of the drawings]

[0088] [Figure 1] FIG. 1 is a schematic diagram illustrating one embodiment of a system according to the present invention. [Diagram 2] 3 is a schematic representation of data exchange during execution of the method according to the invention; [Diagram 3] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 4] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Diagram 5] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 6] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 7] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 8] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 9] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 10] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 11] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 12] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 13] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 14] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 15] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 16] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 17] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; [Figure 18] 3 is a representation of a user interface of a terminal device of the system according to the invention when performing a method according to the invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0089] As a rule, identical parts are marked with identical reference numbers in the figures.

[0090] 1 is a schematic diagram illustrating an embodiment of the system according to the invention. The system comprises a server 10, which is a general computer system suitable for server operation. Among other things, the system comprises a central processing unit 12, as well as a database 14 and a communication interface 16 connected to the central processing unit 12. The computer system is connected to a data network, in particular the Internet, and is protected against unauthorized access locally and from outside using measures known as such. The storage of the database 14 or corresponding data can be realized locally at the server 10 or in the cloud.

[0091] The server 10 communicates with several local terminal devices 100.1, 100.2. These are especially designed as tablets and include communication interfaces 102.1, 102.2, touch screens 104.1, 104.2 and cameras 106.1, 106.2. The communication with the server 10 is carried out via the communication interfaces 102.1, 102.2 via a secure Internet connection (for example secured with TLS). In particular, a valid certificate is used to guarantee that the data arriving at the server 10 originates from a local terminal device 100.1, 100.2.

[0092] The connection between the local terminal devices 100.1, 100.2 and the server 10 can be established directly or a gateway server with which the local terminal devices communicate is located close to the local terminal devices 100.1, 100.2, which then communicates with the server 10. The local terminal devices 100.1, 100.2 are connected to the data network or to the gateway server wirelessly, in particular via WLAN, a cellular connection or Bluetooth.

[0093] The system also includes measurement heads 110.1, 110.2 connected to local terminal devices 100.1, 100.2 via cables 112.1, 112.2. The measurement heads 110.1, 110.2 are supplied with electrical energy via the cables 112.1, 112.2, which are also used to exchange data with the local terminal devices 100.1, 100.2. Alternatively, embodiments are also possible in which the measurement heads comprise a local energy storage device, in particular a rechargeable battery, and the data communication with the local terminal devices is wireless, for example via a Bluetooth connection.

[0094] In the illustrated embodiment example, each of the measuring heads 110.1, 110.2 is equipped with an ultrasound measuring unit and a pressure measuring unit, as described, for example, in EP 3716842 (Veinpress GmbH), i.e. ultrasound data can be generated for imaging and while the ultrasound data is being recorded, the contact pressure between the measuring heads 110.1, 110.2 on the body surface can be determined and output simultaneously. In this case, the ultrasound frequency is about 10 MHz, resulting in a resolution of about 0.07 mm. The required penetration depth is 5-10 cm. The contact pressure is determined via force measurement, for example using (MEMS) strain gauges, capacitive measuring cells or piezoelectric measuring cells. The measurement range is, for example, 0-100 mmHg. From a minimum pressure of 5 mmHg a measurement accuracy of 2-5% is required.

[0095] The corresponding measurement data are transmitted in real time from the measurement heads 110.1, 110.2 to the respective local terminal devices 100.1, 100.2 and synchronized with each other. Ideally, the transmission (and display) of the measurement data occurs at a frequency of 20 frames / s or higher to provide a continuous display for the operator.

[0096] As described below, in particular the following features: - guiding the user through a corresponding user interface (GUI); -capturing and processing user input; - taking a photograph and determining identification data based on the photograph taken; - power supply for the measuring head, - control of the measuring heads 110.1, 110.2, - 110.1, 110.2 Receiving and processing ultrasonic data received by the measuring head, - 110.1, 110.2 Receiving and processing pressure data received from the measuring head, - Presenting the processed results, including ultrasound images and pressure data; and - Two-way communication with server 10 are provided in the local terminal devices 100.1, 100.2 and are controlled by corresponding software.

[0097] In the system according to the invention, an adhesive tag 120 is used. The adhesive tag contains a dot matrix code, for example a QR code, and can be attached to the skin surface in this area to mark the body area. The adhesive used is selected so that the tag 120 remains on the skin surface for a few hours to a few days. At the same time, skin irritation is avoided as far as possible and the tag 120 can be essentially painlessly removed as soon as it is no longer needed. For each body area, several tags 120 with the same code are provided. As mentioned above, one of the tags 120 can be attached to the body area and another one can be attached, for example, to the patient file.

[0098] This embodiment is illustrated using an application example in which the anterior compartment of a patient's left leg 1 is to be examined for possible compartment syndrome (Lowes Syndrome).

[0099] 2 is a schematic representation of the data exchange during the execution of the method according to the invention. The most important data inputs and transmissions between the measuring head 110, the local terminal device 100, the local gateway 20 and the server 10 are shown along the time axis 30, starting from the traumatic impact (time 31). The local gateway 20 is used here only to forward data received from the server 10 to the local terminal device 100 (which may be one of several local terminal devices) or vice versa. The gateway function is therefore not mentioned further below. As already mentioned, the system may also be implemented without the gateway 20, in which case communication takes place directly between the local terminal device 100 and the server 10.

[0100] Generally, the captured data is first temporarily stored on the local terminal device 100. As soon as a connection to the server 10 is established, the data is stored on the server (or a corresponding cloud service). The data is automatically deleted on the local terminal device 100, usually two weeks after the last access. In exceptional cases, when the local memory is no longer sufficient, the data is deleted starting from the oldest data before this period expires. If necessary, the data is retrieved from the server.

[0101] The data will also remain stored in the database or cloud for a specified, longer period of time unless manually deleted at the request of an authorized person.

[0102] The data stored in the database or in the cloud includes, in particular, for each measurement carried out, the following information: -time, - the ID of the measurement, - ID of the tag (patient / body area), - the location of the local terminal device used (via GPS or IP address), - image data of two images having different print values, - Calibration and measurement parameters, -Result value (e.g. CP score, see below) Includes.

[0103] 3 to 18 are examples of user interfaces of a terminal device of the system according to the invention during the implementation of the method according to the invention. It should be noted that not all steps are illustrated, but only the most important ones.

[0104] The user interface is displayed on the touch screen 104.1, 104.2 of the local terminal device 100.1, 100.2. This is also used for user input, which may be performed in a manner known per se by interaction of one or more fingers and / or a pen of the user with the surface of the touch screen 104.1, 104.2. Further input means may be provided, e.g. buttons. The touch screen may be set up to capture pressure-dependent inputs and / or provide tactile feedback. The user interface is shown in greyscale in figures 3 to 17, although user guidance is supported by colours.

[0105] First, a tag 120 is attached (time 32) to the body area to be examined, in this case the lower leg, i.e. below the knee. Now, the camera of the local terminal device 100 is used to capture the affixed tag (Fig. 3), which decodes the corresponding dot matrix code to obtain a unique identification string (ID string). The local terminal device 100 sends this ID string (data 201.1, 201.2) to the server 10 to check whether data linked to this ID string is already available. If this is the case, data 202.2 is transferred from the server to the local terminal device. If not, a response is sent that the data is not yet available and a new local data record is created on the local terminal device to which the ID string is assigned (data 202.1). In the following, it is assumed that no data was yet available on the server 10, i.e. an initial measurement is performed.

[0106] As shown in Figure 4, in the next display, an ID column 151 is now displayed. The operator is asked to enter information about the body area to be examined. In this case, the operator selects the leg to be examined (in this case the left leg) from the schematic body diagram 152. The compartments of this limb that can be examined are then displayed in a selection list 153, and the operator selects the corresponding compartment (in this case the anterior compartment of the lower leg). By pressing the now available button 154, the operator can start the measurement (time 33).

[0107] This is done with the aid of the measuring head 110, whereby the image data and print data generated by the measuring head 110 are transmitted in real time to the local terminal device 100 (data 203.1, 203.2). Now the local terminal device 100 checks whether the measuring head 110 is correctly coupled to it. If this is not the case, a request is made to connect the measuring head or to check it. As soon as the measuring head 110 is present, the operator is prompted to place the measuring head on the body part to be examined. As soon as ultrasound data that can be used for imaging are captured, an ultrasound image 155 is displayed in the user interface (FIG. 5). The ultrasound image 155 is a normal two-dimensional B-scan. In the corresponding display, the operator also has the option to set the penetration depth and therefore also the depth (depth) of the displayed image using a controller 156 and to set the overall amplification (gain) using a further controller 157. Now the operator is also requested to reduce the contact pressure to below 10 mmHg to start the actual measurement process. The contact pressure is shown on a scale 158 running from top to bottom at the right edge of the image. The ultrasound image 155 also shows a centerline 159 along the main detection direction of the ultrasound measurement head, and a depth scale 160 at the left edge of the image.

[0108] Thus, the operator locates the area to be examined and then reduces the contact pressure. As soon as the contact pressure is reduced below 10 mmHg, as shown in FIG. 6, the measurement begins. Now the operator increases the contact pressure continuously, whereby the increase should be made within a time frame of about 1-3 seconds. As soon as the pressure corresponds to 10 mmHg, a first image is automatically saved and displayed in a corresponding image window 161 on the left side of the user interface (FIG. 7). The operator further increases the contact pressure. As soon as the pressure corresponds to 80 mmHg, a second image is automatically saved and displayed in another image window 162 below the first image window 161 (FIG. 8). The measurement process is now completed, which is confirmed to the operator in the user interface.

[0109] The values ​​of the lower and upper contact pressures can be changed manually via a local terminal device if necessary. It is also possible to specify different combinations of values ​​in the system for different compartments in order to capture the elastic properties in the best possible way.

[0110] The two images are then displayed side-by-side in the user interface, with the left image window 163 showing the image at a contact pressure of 10 mmHg and the right image window 164 showing the image at a contact pressure of 80 mmHg. The user can now select one of the image windows 163, 164 in which to mark the distance by pressing the corresponding button 165, 166 ("Set Distance") (FIG. 9).

[0111] FIG. 10 shows how the distance is marked in the left image window 163, where a line 170 along the centerline 159 is provided with two crosshairs 171, 172. These can be moved upwards (towards the body surface) or downwards (away from the body surface) along the centerline 159 using the touch screen until their location coincides with the boundary of the compartment to be examined. The distance between the two crosshairs 171, 172 is shown in the display area 173 and is here 26.1 mm. The same procedure is repeated for the second image in the right image window 164. There, in a situation where the contact pressure is 80 mmHg, the distance is only 22.1 mm (see FIG. 11).

[0112] The crosshairs are positioned with pixel accuracy, meaning an accuracy of about 0.1 mm, which corresponds substantially to the resolution of the ultrasound image. Positioning may be supported by additional display and / or control elements, in particular by line curvature representing the approximate averaged image intensity along the centerline 159 and / or buttons that allow shifting the crosshair position up or down one pixel at a time. Depending on the requirements, the available resolution and the image area to be displayed, a zoom function may also be useful, with which an area in the area of ​​the crosshairs may be enlarged.

[0113] Based on the distance, a so-called "CP score" is now calculated as follows:

number

[0114] If the process is to be completed, the operator is given the opportunity to capture further information regarding the medical history for storage on the server. To this end, the user interface shown in FIG. 13 is displayed, in which: - first selection element 178: type of traumatic injury (open wound, contusion, fracture); - second selection element 179: palpation result (soft, elastic, hard); -Third choice factor 180: general health condition (scale of 1 to 10); - Button 181: Indication that the patient is unresponsive; - 4th option element 182: Drug information can be captured simply and systematically.

[0115] The operator has the option to save the captured data (button 183) or to skip this step entirely ("Skip") (button 184).

[0116] The measurements are now shown in an overview diagram according to FIG. 14. The values ​​of the CP score 175 are represented by data points in a line diagram 185 complemented by a date and time indication 186. Further information regarding the medical history can also be seen in this display. Based on this display, the operator has the option to link a new date to the measurement (or series of measurements) (button 187), to export the data (button 188) or to perform another measurement (button 189).

[0117] The user interface for linking a new tag is shown in Figure 15. A previous tag can be captured by scanning the tag (e.g., in a patient file) or by entering the corresponding tag number.

[0118] The complete data 204.1, 204.2 of the measurements listed above are sent to the server 10 after they are completed.

[0119] Further measurements at the same location at later times 34, 35 are performed in the same manner as the first measurement, using the same or a different terminal device. After scanning the tag, the information is retrieved from the server. Exceptionally, if the same terminal device is used as for the previous measurements at this body part, and if a connection to the server cannot be established, the information stored locally in the terminal device is used. The acquisition of the ultrasound image at the specified pressure value is supported by displaying one of the images of the previous measurement process on the touch screen of the local terminal device as a reference, including the center line and the measurement distance (crosshairs); see FIG. 16, on the left side the image of the previous measurement process is displayed, and on the right side the current view is displayed. Thus, the operator can easily and accurately align the position of the current measurement with the position of the previous measurement.

[0120] After several measurements have been taken, an overview display appears as shown in FIG. 17, where several data points in a line diagram 185 represent the CP scores of several measurements M1 to M5. They are connected by lines and the measurements (except the first one) are complemented by trend indications 190 resulting from a comparison of each measurement with the previous one. Possible deterioration of the compartment status corresponding to an increase in the CP score is highlighted by solid arrows. Thus, the evolution of the CP score can be intuitively captured at a glance.

[0121] The same local terminal device can be used to examine several compartments and / or patients alternately and / or consecutively, so that the terminal device and the server ultimately contain measurements from different people. These can be displayed on the terminal device in a list, as shown in Figure 18, where the CP score of the latest measurement is displayed with a trend indication. The operator receives more detailed information on the corresponding compartment by selecting the corresponding line.

[0122] A local terminal device and corresponding software are not necessarily required to access the information stored in the database 14 of the server 10. This is also possible, with appropriate authorization, via a secure web interface or an application programming interface (API). The API can be used to automatically transfer data to an electronic patient record. It may also be possible to supplement the information stored in the database 14 via the API.

[0123] The web interface allows various operations related to the stored data, in particular: - Displaying data in various formats; - Export data in various export formats; Repeat distance measurements to determine CP score, -Manual deletion of stored data, - Managing users and devices; -Billing function, -Generating and outputting usage statistics; - Managing and installing software and firmware updates; - Check out the tutorials, -Get user support This makes it possible.

[0124] Some of these features may only be used via a special administrator interface or with appropriate access permissions.

[0125] Access to the server via a web or programming interface, whether or not made on a local terminal device, may be recorded in an electronic logbook. The corresponding entries may include, for example, the user, the terminal device, the time viewed and / or a data record. In particular, the logbook may be stored on the server. The logbook may be used, for example, to generate statistics or to perform case-specific clarifications.

[0126] The invention is not limited to the illustrated embodiment: for example, additional data may be captured and processed, such as data regarding the time of the traumatic impact or other information regarding the medical history or photographic or video data to document the examination process.

[0127] The distribution of the capture, processing and output functions to the various system components can be chosen differently: for example, the tags can be captured using a reading device or a camera located in the measurement head, rather than using a camera of a local terminal device.

[0128] The particular characteristics and operating parameters of the measurement head components may be selected differently depending on the application, e.g., the resolution and penetration depth of the ultrasound system, and the pressure range to be captured by the pressure measurement device.

[0129] As explained above, some procedural steps may be automated or supported with the help of automated processes. In this context, the article by A. Crimi et al., "Automatic Measurement of Venous Pressure Using B-Mode Ultrasound", IEE Transactions on Biomedical Engineering, Vol.X, No.X, July 2015, describes a method for detecting tissue structures (specifically veins) and determining their internal pressure by collapsing them using a variable externally applied force. In particular, the image processing and image recognition methods mentioned in this publication may also be used in the context of the present invention.

[0130] As explained above, repeated identification of the patient can also be performed in another way, for example using a separate machine-readable or non-machine-readable data carrier located within the area of ​​the body region to be examined or outside this body region of the patient, or provided independently of this.

[0131] In summary, the present invention provides a method for the non-invasive capture of the temporal evolution of tissue structures, providing improved basic information for diagnostic purposes based on several examinations at different times. [Explanation of symbols]

[0132] 1 Lower Leg 10 Server 12 Central Processing Unit 14 Database 16 Communication Interface 20. Gateway 30 Timeline 31 hours 32 hours 33 hours 34 hours 35 hours 102.1, 102.2 Communication Interface 104.1, 104.2 Touchscreen 106.1, 106.2 Camera 112.1, 112.2 Cable 100, 100.1, 100.2 terminal devices 110, 110.1, 110.2 Measuring head 120 days 151 ID column 152 Body Diagram 153 Selection List 154 Buttons 155 Ultrasound Images 156 Controller 157 Controller 158 scale 159 Center line 160 Depth Scale 161 Image Window 162 Image Window 163 Image Window 164 Image Windows 165 Buttons 166 Buttons 170 lines 171 Crosshairs 172 Crosshairs 173 Display Area 175 Value 176 Buttons 177 Button 178 Selection Elements 179 Selection Elements 180 Selection Elements 181 Button 182 Selection Elements 183 Button 184 Buttons 185 Diagram 186 Date 187 Button 188 Buttons 189 Button 190 Trend indication 201.1, 201.2 Data 202.1, 202.2 Data 203.1, 203.2 Data 204.1, 204.2 Data

Claims

1. A method for non-invasive capture of the temporal evolution of the state of a tissue structure, comprising: a. non-invasively recording first measurement data of a body region to be examined and generating first image data from the recorded measurement data; b. locally preprocessing the first image data using a first local terminal device; c. transmitting the preprocessed first image data and first identification data from the first local terminal device to a server for storage; d. at a later time, retrieving the image data stored on the server using a second local terminal device based on second identification data; e. displaying the retrieved image data on the second local terminal device; f. non-invasively recording second measurement data of the body region for generating second image data. A method as claimed in claim 1.

2. The method according to claim 1, characterized in that when the second measurement data is recorded, the second image data is displayed in real time on the second local terminal device, in particular simultaneously with the retrieved image data.

3. The method according to claim 1 or 2, characterized in that the non-invasive recording of the first measurement data includes a sonographic measurement process.

4. The method according to claim 1, characterized in that the preprocessed first image data is displayed on the local terminal device, and further first measurement data can be recorded based on the display.

5. The method according to claim 1, characterized in that the non-invasive recording of the first measurement data includes measured values of contact pressure.

6. The method according to claim 5, characterized in that in order to obtain information regarding the elastic state of the tissue structure, dimensions are determined in both the first image data and the second image data in each case by forces with at least two different contact pressures.

7. The method according to claim 6, characterized in that a manual marking process is performed on the displayed first image data and second image data to determine the dimensions.

8. The method according to claim 7, characterized in that a representation of the intensity curve of the first image data or the second image data along a line is displayed to support the manual marking process. Claim 9 The method according to claim 7 or 8, characterized in that a proposal for a marking to be performed during the marking process is automatically generated based on the first image data or the second image data. Claim 10 The method according to claim 6, characterized in that the dimension is automatically determined based on the first image data or the second image data. Claim 11 The method according to claim 6, characterized in that a first value for the elastic state of the tissue structure is determined from the determined dimensions at different contact forces based on the first measurement data, a second value for the elastic state of the tissue structure is determined from the determined dimensions at the different contact forces based on the second measurement data, and the first value and the second value represent a measure of the deformability of the tissue structure. Claim 12 The method according to claim 1, characterized in that time information is transmitted to the server for storage together with the preprocessed first image data and the first identification data. Claim 13 The method according to claim 1, characterized in that a medically relevant point in time, in particular the point in time of a traumatic influence, is captured and transmitted to the server for storage. Claim 14 The method according to claim 13, characterized in that a recommendation is generated for the time at which the second measurement data is captured, and the captured medically relevant point in time is taken into account for generating the recommendation. Claim 15 The method according to claim 1, characterized in that an individual marking is applied to the body region to be examined before the first measurement data is recorded, the marking is read by a first reading device, the first identification data is generated based on the read marking, the marking is read again by a second reading device before the stored image data is retrieved, and the second identification data is generated based on the read marking. Claim 16 The method according to claim 15, characterized in that a tag having a unique identification is attached, in particular affixed, to the body region to be examined for applying the individual marking. Claim 17 The method according to claim 15 or 16, characterized in that the first reading device and the second reading device are optical reading devices, in particular cameras.

18. Use of the method according to claim 1 for obtaining information on the elastic state of a compartment.

19. A system for performing the method according to claim 1, comprising: a. A measuring device for non-invasive recording of measurement data of a body region to be examined during a measurement process; b. At least one local terminal device equipped with a display device; c. A server for storing and forwarding the received data, such that the at least one local terminal device and the server are set up for mutual data exchange; the at least one local terminal device is set up to receive measurement data from the measuring device and to generate and display image data from the received measurement data; the at least one local terminal device is set up to transmit identification data and the image data to the server; the at least one local terminal device is set up to retrieve image data stored in the server based on the identification data transmitted to the server and to display the retrieved image data during the measurement process.

20. The system according to claim 19, further comprising at least one reading device for reading an individual marking on the body region to be examined and generating corresponding marking data, wherein the at least one local terminal device is set up to receive the marking data from the reading device and to generate the identification data from the marking data.

21. A computer program comprising instructions which, when the program is executed by a computer, cause the computer to: a. Receive first measurement data from a measuring device, generate first image data from the received first measurement data, and display the first image data on a display device; b. Transmit identification data and the first image data to a server; c. Transmit second identification data to the server. d. receiving, from the server, the image data stored using the second transmitted identification data; e. displaying the received image data on the display device; f. receiving second measurement data from the measurement device, generating second image data from the received second measurement data, and displaying the second image data on the display device A computer program for causing the above to be executed. **Claim 22** When the program is executed by the computer, the computer is caused to receive first marking data from a reading device and generate the first identification data from the first marking data; and receive second marking data from the reading device and generate the second identification data from the second marking data The computer program according to claim 21, further comprising an instruction for causing the above to be executed.

Images