SYSTEM FOR DETERMINING THE ALIGNMENT OF BODY SEGMENTS

DE502018016064D1Active Publication Date: 2025-09-11OTTOBOCK SE & CO KGAA
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Patent Information

Application Number
DE502018016064
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Priority Date
2017-05-17
Filing Date
2018-03-16
Publication Date
2025-09-11
Estimated Expiration
2038-03-16

AI Technical Summary

Technical Problem

Existing prosthetic alignment methods, particularly dynamic alignment, rely heavily on subjective data and lack objective measurement due to challenges in sensor orientation and alignment during movement, leading to inefficient and error-prone prosthetic construction.

Method used

A system comprising sensors attached to body segments via holders, which transmit measurement data and identifiers to an electronic data processing device that automatically determines and assigns the sensor's location, ensuring precise orientation and alignment, thereby providing objective data for dynamic prosthetic design.

Benefits of technology

Enables objective and efficient prosthetic construction by accurately assigning sensor data to body segments, reducing the need for multiple sensors and minimizing errors, thus improving the quality and safety of prosthetic fittings.

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Description

[0001] The invention relates to a system comprising at least one sensor which can be fastened to the body segment by means of a holder, and an electronic data processing device, wherein the sensor is configured to send signals containing measurement data and an individual sensor identifier to the electronic data processing device.

[0002] The construction of a prosthesis, especially a leg prosthesis, must be carefully executed and individually adapted to each patient. This applies both to transfemoral amputees and to transtibial amputees who still have a natural knee joint in the leg being treated. Of course, this also applies to all other prostheses. The prosthesis must be constructed in such a way that, for example, the gait is as natural as possible, so that the wearer of the prosthesis does not have to make uncomfortable, unusual, or unnatural movements to control the prosthesis. At the same time, it must be ensured that the prosthesis provides the wearer with the greatest possible safety in as many situations as possible.

[0003] Traditionally, a static alignment is performed on a standing patient, and a dynamic alignment is performed while the patient is walking. While systems and platforms exist for static alignment that provide objective measurement data to the prosthetist performing the alignment, dynamic alignment is often still performed based on highly subjective data that the prosthetist determines for themselves, for example, by observing the patient's gait. This is particularly disadvantageous when, for example, due to limited space, the prosthetist cannot obtain the necessary perspectives and, for example, cannot view the patient from the side while walking.

[0004] To improve the quality of dynamic prosthetic assembly, it would be advantageous to be able to provide a system in which different sensors, capable of recording the required measurements, could be attached to different parts of the patient's body and / or to different positions on the prosthesis. These sensors could, for example, measure inertial data such as absolute or relative angles, e.g., a knee angle, acceleration, or speed, which provide objective information about the gait pattern and the existing prosthetic assembly. To generate reliable data, however, it is necessary to know the orientation of the sensor on the body or prosthesis as precisely as possible and to ensure that this orientation and / or alignment changes as little as possible, preferably not at all, during walking and the dynamic analysis.

[0005] DE 10 2008 024 746 A1 describes an orthopedic device for the lower extremities in which precisely this orientation and alignment of a sensor on the prosthesis is to be determined. To do this, the system must first be put into a learning mode, in which specific data can be recorded and evaluated in such a way that any errors and inaccuracies in the alignment and / or positioning of the sensors can be detected and calculated from the measured data. Only then can the system switch to the actual operating mode, in which the sensors determine the required values.

[0006] However, checking the orientation and / or alignment of the sensors is not possible in this way unless the learn mode is re-entered at different times. This is time-consuming and not done in practice.

[0007] US 2008 / 0164979 A1, considered the closest prior art, discloses a system comprising several wireless sensors that communicate with an electrical controller. The sensors are attached to different positions on a person and used, for example, during exercise training to measure and track body parameters such as movement, temperature, or skin resistance. Each sensor is assigned an identifier that is used in the electrical controller to distinguish the data transmitted by the sensors.

[0008] The invention is therefore based on the object of proposing a system with which a dynamic prosthesis construction can be carried out simply, reliably and objectively.

[0009] The invention solves the stated problem by a system having at least one sensor that can be attached to the body segment by means of a holder, and an electronic data processing device, wherein the sensor is configured to send signals containing measurement data and an individual sensor identifier to the electronic data processing device, which is characterized in that the at least one sensor takes information about the body segment from the holder and the electronic data processing device is configured to determine the body segment and to assign the measurement data of the at least one sensor to the body segment.This allows a method to be implemented in which at least one sensor is attached to a body segment of a human, the at least one sensor sends signals containing measurement data and an individual sensor identifier to an electronic data processing device, and the electronic data processing device determines the body segment on which the sensor is or is to be arranged and assigns the measurement data of the at least one sensor to the body segment. This assignment preferably occurs automatically. For this purpose, the electronic data processing device preferably recognizes the individual sensor identifier.

[0010] In this context, a body segment is understood to be both a natural body part of a person and a component of an orthosis or prosthesis that the person wears.

[0011] The method assigns the signals emitted by the sensor, which in particular contain the measurement data, to the correct body segment where the sensor is located. This achieves objective measurement data acquisition, which allows for objective dynamic prosthesis design and thus leads to improved quality of the various prostheses. Furthermore, the at least one sensor can be assigned to different body segments, which can be recognized or determined by the electronic data processing device, so that the respective sensor can be used on different body segments for different patients.Particularly in cases where multiple sensors are to be arranged on different body segments, this eliminates the need to maintain a large number of sensors for each individual body segment, as well as a complicated and time-consuming process that would have to be used to ensure that a corresponding sensor is always attached to the intended body segment. This is both time-consuming and impractical for the orthopedic technician and prone to errors. These disadvantages are avoided by the method according to the invention.

[0012] In a preferred embodiment, the at least one sensor transmits the individual sensor identifier only upon request. This request is preferably made via a corresponding control signal that is transmitted by the electronic data processing device and detected by the at least one sensor. If multiple sensors are used, the control signal preferably contains information about which sensor is being addressed and should transmit its individual sensor identifier.

[0013] Alternatively, the at least one sensor can also have an actuating device, for example, a push button. When the actuating device is actuated, the sensor transmits its individual sensor identifier, which is detected by the electronic data processing device.

[0014] InIn a preferred embodiment of the method, at least one detector is assigned to the electronic data processing device, which is configured to detect at least some of the signals from the sensor, wherein the electronic data processing device is configured to determine the body segment from the detected signals, in particular from a direction or position from which the individual special recognition is sent, or from a temporal course of the measurement data.

[0015] The sensor identifier can be emitted, for example, via visible light. This can advantageously be seen via at least one LED, preferably several LEDs, which particularly preferably emit light of different colors. The individual sensor identifier can contain combinations of flashing frequency, colors, intensity and / or pattern, a specific sequence, or a code comprising one or more of these parameters. If the individual sensor identifier is emitted by a sensor, it can be detected by a corresponding detector assigned to the data processing device, which in the aforementioned embodiment can be a camera. Other light-sensitive sensors are of course also conceivable. Alternatively or additionally, the sensor identifier can also contain invisible electromagnetic radiation, for example in the infrared range, and / or audible and / or inaudible acoustic signals, for example in the ultrasound range.Accordingly, the detector must be capable of detecting at least part of this individual sensor identifier, which allows the electronic data processing device to identify the sensor based on the detected parts of the individual sensor identifier. Advantageously, the at least one detector is capable of detecting the complete sensor identifier.

[0016] The at least one detector assigned to the data processing device can advantageously detect not only the individual sensor identifier, but also further information from which the position of the transmitting sensor can be determined. This can, for example, be the direction from which the transmitter identifier is transmitted, so that the electronic data processing device is able to determine the body segment on which the sensor is arranged. The electronic data processing device then assigns the individual sensor identifier of the transmitting sensor, preferably to the respective body segment, so that when the sensor is used, the transmitted measurement data can also be identified as coming from this sensor and assigned to the respective body segment.

[0017] Advantageously, the individual sensor identifier is transmitted to the respective sensor before it is attached to the body segment. Alternatively, the identifier can also be transmitted to the transmitter if the transmitter has already been attached to a body segment of the person. The at least one sensor advantageously receives its individual identifier from a transmitting device connected to the electronic data processing device for this purpose and can preferably transmit an acknowledgment to the electronic data processing device via a suitable communication protocol. From this acknowledgment, which advantageously contains the individual sensor identifier, or from the otherwise transmitted signals, the electronic data processing device can advantageously infer the position and / or direction in which the sensor is located and thus the body segment of the person.

[0018] Alternatively or in addition to this procedure, the electronic data processing device can also use the detected signals, for example, the temporal progression of the measurement data, to determine the body segment where the sensor is located. For this purpose, it is advantageous if the electronic data processing device stores information about the movement sequence to which the detected temporal progression of the measurement data belongs, for example, walking on a level surface, walking on an inclined surface, climbing stairs, sitting down, running, or standing up. By comparing the detected temporal progression of the measurement data with the stored temporal progression of the measurement data, the electronic data processing device can determine the body segment where the sensor, to which the detected measurement data belongs, is located.

[0019] Alternatively, or in addition to comparing with stored temporal histories of measurement data, other classification algorithms can also be used. This could, for example, be a simple sorting based on threshold values ​​or involve a complex, autonomously deciding neural network.

[0020] The sensor signals preferably also contain information about the body segment to which the sensor is attached. This information can be set or determined in a variety of ways. In a particularly preferred embodiment, the sensor or a housing in which the sensor is located has an adjustment device, for example a rotary or slide control. By adjusting this adjustment device, the information about the body segment contained in the sensor signals is encoded. The individual adjustment options, for example of a slide or rotary control, are assigned to the various body segments of the person, so that the person who has or is attaching the sensor to the body segment adjusts the adjustment device accordingly. Alternatively or additionally, the sensor can be attached to the body segment by means of a holder which influences the signals sent by the sensor.The holder is preferably adapted to the respective body segment of the person. A holder for a sensor that is to be arranged on the human torso, for example, is naturally designed differently than a holder for a sensor that is to be arranged on the upper arm, wrist, or knee. Since different holders must be used for the different body segments, the signal emitted by the sensor can be adapted to the body segment in the holder, for example via an electrical circuit or an RFID chip. In this case, it may be advantageous to provide a switch or setting device on the holder that can be used to code whether the holder is arranged on a left or right body segment.

[0021] In a particularly simple embodiment, the sensor according to the invention can extract the information about the body segment from the respective holder.

[0022] The holder is preferably configured to determine the body segment to which it is attached. This can be done, for example, by measuring the circumference of the body segment. If the holder has, for example, an extendable or length-adjustable strap, the type of body segment can be determined from the length of the strap required to grasp and / or enclose the body segment. In this case, for example, it would only have to be additionally determined whether, if the body segment is present multiple times, it is a right or left version of the body segment, for example a leg or an arm. Alternatively, printed barcodes or other codes, orientation markers, glyphs or other elements can be used.

[0023] Preferably, the mount is configured to detect the type of sensor attached to it. Thus, information about body segments and / or sensors can be determined by the mount and sent either from the mount itself to the electronic data processing device or via the sensor.

[0024] Preferably, the sensor has an adjustment device for adjusting the information about the body segment. This can be a manually operable element, such as a rotary or slide control. Depending on the body segment on which the sensor is positioned, these adjustment elements are moved to a specific position and / or orientation, thereby adjusting the information about the body segment, which contains this position of the sensor.

[0025] Preferably, the at least one sensor is configured to transmit the signals to the electronic data processing device only when it has received a corresponding query signal. This ensures that the electronic data processing device only receives signals from a single sensor, preventing multiple signals from different sensors attached to different body segments from overlapping and potentially being unable to be evaluated.

[0026] Preferably, the system comprises at least two sensors which are configured to be attached to different body segments.

[0027] In a preferred embodiment, these at least two sensors are configured to determine information about distances between each pair of these sensors and to transmit this information to the electronic data processing device in the transmitted signals. In this case, the electronic data processing device can use stored patterns of distances to infer the individual positions and body segments to which the sensors are attached.

[0028] In order to determine information about distances between two sensors, it is advantageous if at least one, preferably all of the sensors are capable of emitting corresponding test signals, for example in the form of vibrations, electromagnetic radiation or sound, which can be detected by the other sensors. It has proven advantageous if the sensors that receive corresponding test signals emit a corresponding response signal. The propagation times of the test signal and the corresponding response signal can be used to determine the distances between the various sensors and thus the arrangement of the sensors relative to one another. Since the possible body segments to which sensors can be attached are known, this information can be used to determine which sensor is arranged on which body segment.In addition, if the test signal is sent from the originally transmitting sensor in a specific direction or in a specific spatial area, a distinction can also be made between right and left body segments, for example legs or arms.

[0029] Alternatively or additionally, the sensors can emit test signals that are detected by other sensors. Information about the signals thus detected, in particular the detection times, can then either be transmitted from the detecting sensors to the electronic data processing device or transmitted in the form of response signals to the emitting sensor. Preferably, they are received alternatively or additionally by the electronic data processing device.

[0030] Advantageously, the sensors can determine a distance from another object, for example the ground. This can be done, for example, using ultrasonic signals that are emitted towards the ground. The reflected ultrasonic signals can be detected, and the distance from the ground can be determined from the resulting travel time and the known speed of sound. In this way, it can be determined, for example, whether a sensor is located on a knee, a thigh, or a shoulder. Of course, other body segments can also be detected, as long as they are at different distances from the ground. Alternatively or additionally, a precise positioning system, for example a Global Positioning System (GPS), can be used to determine the position of the individual sensors as precisely as possible and thus establish on which body segment the sensors are located.

[0031] To determine the positions of the individual sensors relative to each other or relative to a specific point on the wearer's body, body signals emitted by the human body can also be used. For example, pulse rate, heart rate, corresponding blood pressure, and / or ECG can be used to determine the distance of the sensor from the human heart. Of course, all other biosignals emitted by the body that allow for location and / or distance determination can also be used alone or in combination with other signals listed here.

[0032] The invention further achieves the stated object by a method in which at least one sensor is attached to a body segment of a human, the at least one sensor sends signals containing measurement data to an electronic data processing device, the electronic data processing device sends a control signal to the at least one sensor, and the at least one sensor sends a response signal detectable by a human in response to the control signal. This response signal, for example an audio signal, a haptic signal, and / or an optical signal, is detected by a human, for example an orthopedic technician, who then preferably communicates the position of the corresponding sensor to the electronic data processing device. For this purpose, the electronic data processing device has an interface through which a human can enter corresponding data into the data processing device.

[0033] The invention also solves the stated problem by a system having at least one sensor and an electronic data processing device, which is configured to carry out such a method.

[0034] The at least one sensor must, of course, be attached to a prosthesis or orthosis. These elements then preferably form a system comprising an orthosis and / or a prosthesis and a mount for attaching a sensor to an object. The mount has at least two fastening elements for attaching the mount to the object, which are spaced apart from each other by at least one spacer element, and at least one sensor fastening element for attaching the sensor to the mount. The at least one spacer element has a lower flexural rigidity in a first direction than in a second direction perpendicular to the first direction.

[0035] Such a system represents a standalone invention or can be used in combination with other features described herein. This also applies to a mount for such a system.

[0036] Traditionally, sensors are attached to a body part or prosthetic part, for example, using a strap that is wrapped around the body part or prosthetic part. This often results in rotation of the sensor relative to the body part, such as a thigh, which must be detected and quantified for optimal evaluation of the measurement data acquired by the sensor. Furthermore, vibrations and accelerations that occur when walking can cause the sensors to shift or slip relative to the body part or prosthetic part.

[0037] In this context, a body segment is understood to be both a natural body part of a person and a component of an orthosis or prosthesis that the person wears.

[0038] The orientation of the spacer element located between the two fastening elements is determined by the two fastening elements provided according to the invention, which can be in the form of two straps, for example, that are placed around the respective body part or prosthetic part. Rotation or displacement of this element relative to the body part or prosthetic part, for example relative to the thigh, is only possible to a very limited extent, and preferably not at all. The orientation of at least the spacer element relative to the object, i.e. in particular relative to the body part or prosthetic part, is thus determined and cannot be changed, or can only be changed insignificantly. The sensor itself is attached to the holder, particularly preferably to the spacer element, via the sensor fastening element.For example, markings provided on the sensor or on the sensor housing in which the sensor is located allow the relative orientation of the sensor housing or the sensor relative to the spacer element to be easily read and advantageously adjusted. In this way, the alignment and orientation of the sensor relative to this object can be determined and specified as soon as the sensor is attached to the object, preferably to the body part or prosthetic part.

[0039] The special design of the spacer element with its anisotropic flexural rigidity ensures that an optimal orientation for the sensor is maintained while still allowing movement in a different direction. A sensor can, for example, be an acceleration sensor or an angle sensor, which should be aligned with a known, fixed longitudinal axis on the sensor, for example parallel to the object, such as a thigh, in order to obtain optimal measurement data. This is easily possible with a holder according to the invention. The two fastening elements are fixed at two positions on the thigh that are spaced apart from one another by the spacer element. This ensures that the spacer element extends parallel to the thigh, for example to the femur.The sensor, which is preferably already attached to the holder or can be subsequently attached to it, therefore has a previously known, preferably adjustable orientation relative to the spacer element and thus relative to the thigh. The imaginary longitudinal axis of the thigh and the corresponding direction of the sensor to be determined run parallel and therefore span a plane. The spacer element now has different flexural rigidities in two different directions, which are advantageously positioned such that the flexural rigidity is particularly high for bends of the spacer element that move the predetermined sensor direction out of the plane spanned by the axis of symmetry of the thigh, so that such a movement, which would change the orientation and thus reduce the quality of the measurement data, is difficult or preferably not possible at all. Ina direction perpendicular to it, which advantageously does not lead the predetermined direction of the sensor out of the plane spanned by the axis of symmetry of the thigh, is, however, much easier to achieve, since the flexural rigidity is reduced here.

[0040] This is of course not limited to embodiments in which a sensor is attached to a person's thigh.

[0041] Preferably, the at least one spacer element is a compressive force transmission element. This ensures that the two fastening elements always have the same distance and that the spacer element is compressively rigid.

[0042] InIn a preferred embodiment, the at least one spacer element comprises at least two adjacent individual elements, in particular webs, braces, rods, or tubes. This makes it particularly easy to achieve the different flexural rigidities, since the individual elements themselves can have isotropic flexural rigidity, i.e., the same in all directions, and the desired different flexural rigidities of the spacer element are achieved simply by positioning the different individual elements next to one another.

[0043] It has proven particularly advantageous if the individual elements are formed integrally with one another. Particularly preferably, the entire spacer element, and particularly preferably the entire holder, is formed integrally. It can, for example, be a plastic element that has been cut, sawn, or punched out of a plastic sheet. Alternatively, 3D-printed components or metallic components can also be used. In a preferred embodiment, the individual elements are made of a plastic or a fiber composite material, in particular a carbon fiber composite material or a glass fiber composite material. This is particularly advantageous if the individual elements and the spacer element are not formed integrally.In this case, carbon fiber rods or fiberglass rods can be used, which are easy to manufacture, have high flexural rigidity and yet have a low weight.

[0044] Preferably, the at least one sensor fastening element is arranged on the at least one spacer element. It has proven particularly preferred if the sensor fastening element is arranged in the middle between the two fastening elements.

[0045] Advantageously, the sensor fastening element is detachably arranged on the at least one spacer element, preferably clamped or clipped on. In this way, for example, the sensor used can be particularly easily replaced if this is necessary due to the required measurement data or for maintenance and / or repair of the sensor. Furthermore, the sensor fastening element can be arranged displaceably along the longitudinal extent of the spacer element, so that the position of the sensor on the object, for example, on the body part or on the prosthetic part, can be subsequently adjusted and brought to the optimal position. At the same time, the orientation of the at least one sensor is not affected.

[0046] The object preferably has a longitudinal direction and is in particular a prosthetic component, an orthotic component or a segment of a human body. The holder is preferably designed such that a direction in which the at least two fastening elements are spaced from one another corresponds to the longitudinal direction or runs parallel to it when the holder is arranged on the object. This direction advantageously corresponds to an extension direction of the spacer element. If the holder is arranged, for example, on a prosthetic component or a segment of a human body, this ensures that the orientation of the holder and thus preferably also the orientation of the sensor relative to the object is fixed, such that incorrect operations and the resulting inaccurate or incorrect measured values ​​are prevented or at least reduced.

[0047] The at least one sensor preferably comprises an inertial sensor, in particular an electromagnetic spatial position sensor, an angle sensor, an acceleration sensor, a sensor for detecting biosignals of the human body, for example ECG, blood pressure, pulse or the like, and / or an electromagnetic tracker.

[0048] A system comprising such a holder and a sensor fastened to the at least one sensor fastening element also constitutes an independent invention that can also be used in combination with other features described here. Advantageously, the at least one sensor fastening element and the at least one sensor are designed such that the sensor can be fastened to the sensor fastening element in only a few, preferably two, particularly preferably only one orientation. This ensures that the sensor can only be fastened in certain orientations, so that the orientation of the sensor relative to the holder and thus relative to the spacer element or the sensor fastening element does not have to be detected, checked, and possibly adjusted, and furthermore is not a source of measurement errors or other inaccuracies.

[0049] If the prosthetic structure is to be examined dynamically, it is advantageous to be able to arrange sensors at different locations and body segments of a person. An electronic data processing device is then preferably capable of assigning measurement data and signals, which in particular also include an individual sensor identifier, to the body segment to which the respective sensor is attached.

[0050] The construction and / or adjustment of an orthosis and / or prosthesis is of great importance for comfort and functionality. It is therefore advantageous to check the adjustment. This is achieved by a method for adjusting a prosthesis or orthosis or for determining malpositions in the construction of a prosthesis or orthosis of the lower extremity, comprising the steps of a) recording first measurement data from at least one sensor that is attached to a body segment of a human, wherein the first measurement data are assigned to a first movement state of the human, b) recording second measurement data from at least one sensor that is attached to a body segment of the human, wherein the second measurement data are assigned to a second movement state of the human, and c) evaluating the first and second measurement data.

[0051] This method is an independent invention or can be used in combination with other features described herein.

[0052] This method is based on the realization that optimal prosthetic design often requires recording and simultaneously evaluating sensor data in different movement states. Therefore, the first movement state and the second movement state are different from each other. This method provides information that cannot be obtained by simply evaluating the measurement data from only one of the two movement states. Of course, this requires that the two movement states be different from each other.

[0053] The method can be carried out entirely by a computer or an electronic data processing device, provided that the computer has access to the recorded first and second measurement data. These are transmitted by the respective at least one sensor to the electronic data processing device and advantageously stored in an electronic data storage device.

[0054] In a preferred embodiment, the second movement state is selected based on the first measurement data. Preferably, the first measurement data are evaluated first. This allows indications of existing misalignments to be identified, which can then be verified, confirmed, or refuted by measurements in a second movement state. It is therefore often advantageous to first select the first measurement data in order to select the optimal second movement state, so that the second measurement data can be used to resolve any remaining uncertainties and / or ambiguities from the first measurement data.

[0055] Alternatively, it is of course also possible to assign a fixed second movement state to a selected first movement state. For example, if the first movement state is climbing stairs, it may be useful to assign it climbing stairs down or walking on an inclined plane, i.e. an upward or downward incline. Using such a fixed assignment, a multitude of different misalignments can be determined from the measured data. The fixed assignment is useful when only a single second movement state can be assigned to a first movement state. As soon as ambiguities arise and different second movement states can result for different evaluation results from the evaluation of the first measurement data, such a fixed assignment is no longer useful.

[0056] For certain prostheses and / or patients, it is also useful to use more than two motion states and to record separate measurement data in each of these multiple motion states. In this case, it is advantageous to choose a fixed order for the different motion states and to assign the recorded measurement data to the current motion state.

[0057] Preferably, the selected second movement state is displayed via a communication device, in particular by an audio signal and / or a haptic signal and / or a visual signal. A device with which the method can be carried out therefore has a communication device, for example a display or a display device, which can be in the form of differently colored LEDs, lamps, or other display elements. Of course, a loudspeaker can also be provided, via which audio signals, for example spoken words, can be emitted. Preferably, the communication device also has a microphone, so that voice input of commands or instructions is possible.After the first measurement data has been evaluated and the second movement state has been determined on the basis of this evaluation, a user of the device, for example an orthotist, is informed via the communication device which movement state this is. The patient is then prompted, for example by the communication device or by an orthotist, to assume the next movement state and, for example, to climb stairs, walk faster or slower, stand up or sit down. It should be noted, however, that the method can be carried out regardless of whether the person actually performs the different movement states. The measurement data determined following a request from the communication device are assigned to the second movement state regardless of whether the second movement state was actually assumed and correctly performed or not.As already explained, the method can be carried out entirely by a computer that has access to the measurement data recorded by at least one sensor.

[0058] Advantageously, the first movement state is identified from the first measurement data and / or the second movement state is identified from the second measurement data. This can be done, for example, by storing certain measurement data patterns, such as a knee angle pattern while walking, in an electronic data storage device. The recorded measurement data is then compared with a series of these different movement patterns and data patterns until a match is found. The corresponding movement state is identified as the first movement state or second movement state and assigned accordingly to the measurement data.

[0059] Preferably, after evaluating the first and second measurement data, a corrective measure is determined and preferably output via the communication device. This corrective measure relates to the prosthetic structure and can, for example, consist of a displacement of the foot relative to the lower leg and / or the knee, or a different positioning of the individual components of the prosthesis relative to one another. However, the corrective measure can at least also or only consist of exchanging a component used in the orthosis or prosthesis for another component and thus, for example, exchanging a prosthetic foot used in a leg prosthesis for a different prosthetic foot. This can ensure that the wearer of the prosthesis or orthosis receives and can use not only an optimally constructed prosthesis or orthosis, but also a prosthesis or orthosis consisting of the most optimal combination of individual components.

[0060] Preferably, the corrective measure is transmitted by the communication device to a component of the prosthesis or orthosis. This can be done wired or wirelessly, for example via radio, Wi-Fi, or Bluetooth. The component of the orthosis or prosthesis is preferably configured to convert the corresponding signals and implement the corrective measure contained therein in response to the received signals. This can be done, for example, by increasing or reducing flexion resistance, changing the position of a component, or adjusting damping. Safety-relevant changes and / or corrective measures should preferably be confirmed by a human, for example, an orthotist.

[0061] The corrective measure should preferably be as specific as possible so that it can be easily implemented by an orthotist. For example, it can include instructions on which screw or adjustment mechanism should be turned, how far, and in which direction, or in what manner.

[0062] In addition to or as an alternative to a corrective measure, a training recommendation can also be given to teach the person how to optimally use the prosthesis or orthosis.

[0063] When evaluating the first and second measurement data, technical properties and / or limitations of the orthosis or prosthesis and / or ranges of motion and / or limitations of the person are preferably taken into account. If, for example, a prosthetic knee joint in use cannot allow stance phase flexion, this is taken into account when evaluating the measurement data. In this case, it is obviously not sensible to attempt to achieve stance phase flexion through corrective measures. If it is nevertheless considered advantageous and / or necessary, the corrective measure instead involves replacing the knee joint. Movement restrictions of the person, such as restricted ranges of motion, are also preferably taken into account in order to achieve the most optimal and individually determined design of the prosthesis or orthosis through the process.This data is preferably stored in a database and can, for example, be entered manually. It is understood that the electronic data processing device has access to this database.

[0064] Such limitations of the components used or the patient are preferably queried before performing the procedure and stored in a database accessible by the electronic data processing device. Alternatively, they can also be imported and stored via data transmission, for example, from a storage medium or online.

[0065] It is advantageous if a biomechanical model of the human with orthosis or prosthesis is stored and parameterized based on the first measurement data and / or the second measurement data, which is then used to calculate kinetic data from kinematic data.

[0066] Advantageously, the first measurement data and / or the second measurement data originate at least also from sensors that are attached to an untreated extremity of the person. Preferably, a portion of the healthy, i.e. untreated, body segments of the person are attached, while another portion is attached to treated body segments, i.e. to the prosthesis itself. Preferably, a symmetry of the gait pattern is determined from the first measurement data and the second measurement data. A sensor that is arranged on a prosthesis is also considered to be attached to a body segment of the person within the scope of the present invention. A body segment is understood here to mean both a natural body part of a person and a component of an orthosis or prosthesis that the person wears.

[0067] Suitable sensors include angle sensors, inertial sensors, pressure sensors, force and / or torque sensors, video sensors, or image sensors. Combining data from different sensors and / or different motion states yields new insights that would not be possible without this combination. Data from different sources is preferably fused.

[0068] In this way, measurement data from both the treated and untreated extremities can be recorded and compared. This is particularly advantageous for symmetry analyses and measurements. This applies, for example, to the measurement of stride length or double stride length, as well as stride duration or double stride duration. Gait speed, the maximum knee angle during the stance phase, or the maximum knee angle during the swing phase can also be determined for both extremities in this way and compared for symmetries. If asymmetries are detected, this can indicate appropriate corrective measures.Other variables that can be determined by the at least one sensor include, for example, the type of circumduction performed by the patient, the maximum ground clearance in the swing phase of a step, the minimum knee angle in the stance phase, and the percentage share of the stance phase and / or the swing phase in the gait cycle, with particular attention being paid to the temporal duration. Of course, cadence, distance and other parameters, such as knee angular velocities, can also be determined. During the evaluation of the measured data, further derived variables, in particular time derivatives or relative angles, can be determined from the original measured data obtained in this way, which come directly from the sensors. All of this data and measured data are preferably used as the basis for the evaluation in order to ensure the most optimal prosthetic design possible.

[0069] Preferably, the first movement state or the second movement state is standing, slow walking, fast walking, climbing or descending stairs, walking up or down an incline, standing or sitting, standing up or sitting down, or tiptoeing on the spot (alternately lifting the legs). Acceleration is also such a movement state. Advantageously, the first movement state and the second movement state also differ or only differ in the condition of the floor. The movement of the first movement state, for example walking on level ground, is performed on a different floor surface than the movement of the second movement state. The movements can be performed, for example, on hard floors, such as stone, concrete or wood, or on soft floors, such as sand, forest floor, grass or carpet.

[0070] When evaluating the first and second measurement data, these are preferably compared with stored reference data, which is preferably stored in an electronic data storage device. This may be data from other people, for example, other patients with the same illness or disability and / or the same orthosis or prosthesis.

[0071] For such a method, a system is preferably used with at least one sensor for attachment to a body segment of a human and an electronic data processing device configured to carry out a method described here. The system preferably has a communication device, which is designed in particular as a display. Here, too, a sensor arranged on a prosthesis or a component of the prosthesis is considered a sensor on a body segment of the human.

[0072] The electronic data processing device is preferably configured to independently determine and perform a suitable functional test. Common tests include a "timed up and go test (TUG)," a "functional reach test (FRT)," a "2-minute walk test (2MWT)," or a "four-square step test (FSST)."

[0073] From measurement data collected during walking, which constitutes the first movement state, and during tripping, which constitutes the second movement state, the parallelism of the feet (position of the feet relative to each other) as well as the symmetry of step length and the symmetry of the stance phase duration can be determined. If all of these parameters are known, which cannot all be obtained from data from just one movement state, flexion contracture, for example, can be assessed.

[0074] In order to assess swing phase extension and / or swing phase flexion, measurement data are preferably recorded during slow walking (first movement condition) and during acceleration (second movement condition).

[0075] If it is determined during a first movement state that the person is trying to compensate for misalignments through other movements, the second movement state can also consist of a "relaxed" execution of the same movement, for example walking.

[0076] The task is solved by a procedure in which a. at least one sensor is attached to a body segment of a human, b. the at least one sensor sends signals containing measurement data and an individual sensor identifier to an electronic data processing device, and c. the electronic data processing device determines the body segment on which the sensor is or is to be arranged and assigns the measurement data of the at least one sensor to the body segment.

[0077] This method is preferably characterized in that at least one detector is assigned to the electronic data processing device, which detector detects at least part of the signals of the sensor, wherein the electronic data processing device determines the body segment from the detected signals, in particular from a direction or position from which the individual transmitter identification is sent or from a temporal course of the measurement data.

[0078] Alternatively or additionally, the method is characterized by the fact that the sensor signals contain additional information about the body segment.

[0079] Preferably, the method is characterized in that the sensor is attached to the body segment by means of a holder which influences the signals sent by the sensor.

[0080] Preferably, the method is characterized in that the sensor extracts the information about the body segment from the holder.

[0081] Preferably, the method is characterized in that the holder determines the body segment to which it is attached.

[0082] Preferably, the method is characterized in that the sensor has an adjustment device by which the information about the body segment is adjusted.

[0083] Preferably, the method is characterized in that the at least one sensor only sends the signals to the electronic data processing device when it has received a query signal.

[0084] Preferably, the method is characterized in that at least two sensors are attached to different body segments.

[0085] Preferably, the method is characterized in that the sensors are configured to determine information about distances between two sensors and to send this information in the transmitted signals to the electronic data processing device.

[0086] Preferably, the method is characterized in that the sensors emit test signals which are detected by other sensors and information about the signals thus detected, in particular detection times, is transmitted from the sensors to the electronic data processing device.

[0087] The task is solved by a method in which a. at least one sensor is attached to a body segment of a human, b. the at least one sensor sends signals containing measurement data to an electronic data processing device, and c. the electronic data processing device sends a control signal to the at least one sensor, and the at least one sensor sends a human-detectable response signal in response to the control signal.

[0088] With the aid of the accompanying drawings, exemplary embodiments of the present invention are explained in more detail below. They show: Figure 1- a system with several sensors that can record information about movements, positions and / or orientations, according to a first embodiment of the present invention, Figure 2- the schematic representation of another system, Figure 3- the schematic representation of a leg with two holders according to an embodiment of the present invention, Figure 4- the representation of a holder according to an embodiment of the present invention, Figure 5- the representation of a holder, Figures 6 and 7- schematic details of the holder from Figure 5 , Figures 8 and 9- schematic representations of fastening elements, Figure 10- the schematic representation of a further holder and Figure 11 the schematic representation of a method.

[0089] Figure 1shows a person 2 to whose body a plurality of sensors 4 are attached. The sensors 4 determine measured values, for example absolute angles, relative angles, speeds or accelerations and can advantageously transmit these wirelessly to an electronic data processing device 6. In order for the measured values ​​determined by the sensors 4 to be correctly evaluated in the electronic data processing device 6, the sensor must first be assigned to a body segment 8. For the sake of clarity, only one body segment 8 is shown, namely the one shown in Figure 1 The upper arm of person 2 shown on the left is marked.

[0090] In order to be able to assign the sensors 4 to the different body segments 8, the electronic data processing device 6 in the embodiment shown sends a signal 10 with which the sensor 4 arranged on the body segment 8 is stimulated to send out a sensor signal, or response signal.

[0091] Figure 2 shows another embodiment in which the person 2 has sensors 4 only in the area of ​​the arms. In particular, the sensors on the upper and lower arms can be arranged on the upper arms and lower arms by means of holders according to the embodiment of the present invention, which are described in more detail below. Figure 2Sensor 4, shown at the top right of the upper arm, transmits signals 10 that can be detected by the other sensors 4. By determining travel times, distances between the sensors 4 can be determined, and thus, by comparing them with predetermined, calculated, or measured patterns, the arrangements of the individual sensors 4 on the body segments 8 can be determined.

[0092] Figure 3 shows schematically a leg 12 on which two sensors 4 are arranged. This is done via holders 14, which can be designed according to the invention and in Figure 3 are only shown schematically.

[0093] Figure 4 shows such a holder 14. It has two fastening elements 16, which are separated from each other by a spacer element 18. The two fastening elements 16 have slots 20 through which, for example, a fastening strap can be passed, so that the holder 14 can be attached to the respective body segment 8.

[0094] In the illustrated embodiment, the spacer element 18 comprises two individual elements 22 arranged side by side. This ensures that the flexural rigidity of the spacer element 18 in a first direction is significantly lower than the flexural rigidity in a second direction.

[0095] Figure 5 shows another embodiment of the holder 14. It also has two fastening elements 16, between which is the spacer element 18, which again has two individual elements 22. On these individual elements 22 is a sensor fastening element 24, which in the illustrated embodiment is designed to be displaceable along the individual elements 22 and thus along the spacer element 18.

[0096] Figure 6shows an enlarged view from a different perspective of one of the fastening elements 16. Two openings 26 can be seen into which the individual elements 22 are inserted. On the fastening element 16 there is a strap 28 which can be placed around a body part. In the exemplary embodiment shown, at the free end of the strap 28 there is a hook and loop fastener element 30 which can be attached to an outer side 32 of the strap 28 so that the strap 28 is closed and the fastening element 16 is arranged on the body segment 8. In the exemplary embodiment shown, on a side of the fastening element 16 facing the body segment 8 there is an anti-slip coating 34 which is intended to prevent the fastening element 16 and thus the holder 14 from slipping relative to the body segment 8.

[0097] Figure 7shows the sensor fastening element 24 and the individual elements 22, which are only shown in dashed lines. The sensor fastening element 24 has two clamping arms 36, which at least partially encompass the individual elements 22, as shown, and thus fasten the sensor fastening element 24 to the individual elements 22. In the exemplary embodiment shown, an anti-slip coating 34 is located between the individual elements 22 and the clamping arms 36 of the sensor fastening element 24, which prevents accidental displacement and slipping of the sensor fastening element 24 relative to the spacer element 18 and its individual elements 22.

[0098] The Figures 8 and 9show a fastening element 16 in the form of a belt 28. It has an adjustment device 38 with a rotary control 40. The rotary control can be adjusted depending on the body segment 8 on which a sensor with this fastening element 16 is arranged. The corresponding identifier is shown on a small display 42. In the illustrated embodiment, a slide control 44 can also be used to adjust whether a sensor 4, which is arranged on a holder 14 equipped with such a fastening element 16, is arranged on the right or left side of the body.

[0099] By adjusting the rotary control 40 and the slide control 44, for example, a signal that is sent by the respective sensor 4 can be converted to a request signal 10, as is the case, for example, in Figure 1is schematically shown. In this way, identical sensors can be used for, for example, different patients at different locations and body segments 8 without the need to adjust the sensors or the electronic data processing device.

[0100] Figure 10shows a further embodiment of a fastening element 16, which again has a strap 28. In addition, the spacer element 18 is shown in a side view, which in the exemplary embodiment shown is designed such that the sensor 4 can be arranged directly on the spacer element 18. Both the spacer element 18 and the sensor 4 have an electronic assembly 46, which are brought into electrical contact by arranging the sensor 4 on the spacer element 18. In this way, a signal that the sensor 4 sends to an electronic data processing device 6 is modified, so that the electronic data processing device can derive information from the signal about the type of sensor 4 and / or the position and orientation of the sensor 4, i.e. in particular the body segment 8.

[0101] Figure 11shows the schematic process for setting up a prosthesis or orthosis, or for determining misalignments in the construction of a prosthesis or orthosis. The present procedure is intended to check whether a prosthetic foot is correctly positioned in the anterior-posterior direction or whether it needs to be moved in the anterior or posterior direction. For this purpose, the first measurement data is recorded in the first step of the procedure, labeled "slow walking." This is preferably the knee angle, i.e., the angle between the thigh and the lower leg. This can be done, for example, using two inertial angle sensors that measure the angle of the thigh relative to the vertical and the angle of the lower leg relative to the vertical. The vertical is the direction along the force of gravity. The initial measurement data thus recorded are then evaluated to determine whether stance phase flexion is present.If this is not the case, the second measurement data is recorded in a subsequent process step, labeled "fast walking." Fast walking constitutes the second movement state. Slow walking and fast walking are not initially restricted to specific walking speed ranges. The designations simply indicate that the first movement state, "slow walking," has a lower forward speed than the second movement state, "fast walking." The walking itself takes place on a plane that is preferably perpendicular to the vertical, i.e., along the horizontal. This plane advantageously does not exhibit an incline.

[0102] The second measurement data recorded in this way are also examined to determine whether stance phase flexion is present. Stance phase flexion is a flexion of the knee during the first half of the stance phase of a gait cycle. After heel strike, there is a brief reduction in the knee angle, i.e., a flexion of the knee. If this is not present in either movement state, i.e., in either recorded measurement data, it is recommended to move the prosthetic foot in a posterior direction. Plantar flexion should then be adjusted in a static setup. However, if stance phase flexion can be detected from the first measurement data and / or the second measurement data, it must be checked whether it is occurring within an appropriate speed range and is of sufficient strength.Stance phase flexion that is too rapid or excessive is also due to misalignments in the prosthetic assembly that must be corrected. To do this, it is suggested to shift the foot anteriorly and then, preferably, to statically adjust the plantar flexion. This procedure is repeated until the flexion criterion is met and the anterior-posterior alignment of the prosthetic foot is sufficiently determined. This procedure is preferably performed on transtibial amputees who therefore have a natural knee. List of reference symbols

[0103] 2 Person 4 Sensor 6 Electronic data processing device 8 Body segment 10 Signal 12 Leg 14 Bracket 16 Fastening element 18 Spacer element 20 Slot 22 Single element 24 Sensor fastening element 26 Opening 28 Strap 30 Hook and loop fastener 32 Outer surface 34 Anti-slip coating 36 Clamp arm 38 Adjustment device 40 Dial 42 Display 44 Slider 46 Electronic assembly

Claims

1. A system with at least one sensor (4), which can be fixed to a body segment (8) by means of a mount (14), and an electronic data processing device (6), wherein the sensor (4) is configured to send signals containing measurement data and an individual sensor identification to the electronic data processing device (6), characterised in that the at least one sensor (4) draws information from the mount (14) about the body segment (8) and that the electronic data processing device is configured to determine the body segment (8) and to allocate the measurement data of the at least one sensor (4) to the body segment (8).

2. The system according to claim 1, characterised in that at least one detector is allocated to the electronic data processing device (6), said detector being configured to detect at least one part of the signals of the sensor (4), wherein the electronic data processing device (6) is configured to determine the body segment (8) from the detected signals, in particular from a direction or position from which the individual transmitter identification is transmitted or from a time course of the measurement data.

3. The system according to claim 1 or 2, characterised in that the mount (14) is configured to determine the body segment (8) to which it is fixed.

4. The system according to one of the preceding claims, characterised in that the sensor has an adjustment device by means of which the information about the body segment (8) is adjusted.

5. The system according to one of the preceding claims, characterised in that the at least one sensor (4) is configured to only transmit the signals to the electronic data processing device (6) when it has received a request signal.

6. The system according to one of the preceding claims, characterised in that the system comprises at least two sensors (4) that are configured to be fixed to different body segments (8).

7. The system according to claim 6, characterised in that the sensors (4) are configured to determine information about distances between two sensors (4) and to send said information in the transmitted signals to the electronic data processing device (6).

8. The system according to claim 7, characterised in that the sensors (4) are configured to emit test signals which are detected by other sensors (4) and by means of which information about the signals detected in this manner, especially detection times, is transmitted from the sensors (4) to the electronic data processing device (6).