Method, computer program, and system for adjusting an orthopaedic device

EP4548361A1Pending Publication Date: 2025-05-07OTTO BOCK HEALTHCARE PROD GMBH
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Patent Information

Application Number
EP2023737969
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-07-01
Filing Date
2023-06-30
Publication Date
2025-05-07

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Abstract

The invention relates to a method for adjusting a microprocessor-controlled orthopaedic device worn on the body of a patient fitted therewith, which influences movement by microprocessor-controlled actuation of actuators, the method comprising the following computer-implemented steps: - a digital communications connection is provided from a mobile terminal to an adjustment database in which at least one adjustment value for at least one parameter of the respective microprocessor-controlled actuation as well as accompanying patient data relating to a patient fitted with the respective orthopaedic device are stored for each of a plurality of microprocessor-controlled orthopaedic devices; - at least one adjustment value for at least one parameter of the microprocessor-controlled actuation of the patient's orthopaedic device is calculated based on data relating to the patient whose microprocessor-controlled orthopaedic device should be adjusted and / or the adjustment values and accompanying patient data stored in the adjustment database; - the at least one calculated adjustment value is displayed on the mobile terminal in order to adjust the microprocessor-controlled orthopaedic device.
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Description

[0001] Method, computer program and system for adjusting an orthopaedic device

[0002] The invention relates to a method, a computer program and a system for adjusting a microprocessor-controlled orthopaedic device which is worn on the body of a patient equipped therewith and which influences the movement sequence by a microprocessor-controlled control of actuators.

[0003] For the purposes of the present invention, orthopedic devices (also referred to as orthopedic devices or equipment) include, in particular, orthoses, prostheses, exoskeletons, and possibly also wheelchairs. Orthoses are products that support, assist, protect, or restrict the movement of a patient's body part, such as a joint, in order to prevent excessive strain. Prostheses, on the other hand, do not replace, or no longer replace, the patient's body parts. Exoskeletons are, in particular, mechanical support structures designed to support, assist, or protect the patient's main musculoskeletal system.

[0004] In the following, a patient is defined as any user of the orthopedic device. This is therefore the provider of the orthopedic device.

[0005] Orthopedic devices such as orthoses, prostheses, or even cuffs, wheelchairs, exoskeletons, and the like are used individually. Orthopedic devices can have drives, locks, brakes, and / or dampers that are activated or deactivated via a correspondingly configured control device. The control device can be connected to one or more sensors to change the behavior of the orthopedic device based on sensor data. Based on the sensor data and the settings used to configure (adjust) the orthopedic device, the actuators of the orthopedic device are then controlled by the microprocessor-controlled control device to achieve the desired behavior of the orthopedic device.

[0006] US Pat. No. 6,679,920 B2 discloses a device and method for remote maintenance of an electronically controllable prosthesis. The prosthesis is a prosthetic leg equipped with a prosthetic socket, a prosthetic knee joint, a lower leg section, and a prosthetic foot. A hydraulic damper is arranged between the prosthetic socket and the lower leg section, which adjusts the damping of the hydraulic damper based, for example, on forces or accelerations. A separate maintenance device or docking station can be connected to the control unit of the prosthesis. The maintenance device collects the control and movement data of the prosthesis, evaluates it, processes it, and, if necessary, provides the control unit of the prosthesis with an updated data set. Data transmission can be wireless via a data network or a telephone line.

[0007] US 10,015,840 B2 relates to a device and method in which sensor data from a separate wearable unit is collected and compared with a movement model. If the model does not match the sensor data, correction commands are transmitted. Once a sufficient correction is available, the correction is terminated.

[0008] US 2005 / 107726 A1 relates to a method for remote monitoring of an orthosis. A healthcare professional is in audiovisual contact with an orthosis user who is using the orthosis to perform exercises after an injury or similar. At the same time, data from the orthosis, such as angle or force sensors, is transmitted to the healthcare professional. This serves to monitor correct execution of the exercises. Patient data, which is decoupled from personal data, is entered into a database in order to then compare the effectiveness of a therapeutic approach in several similar cases and, if necessary, improve it. US 2008 / 103506 A1 relates to a wearable unit in the form of an orthosis, which is also used in recovery after a stroke or similar condition. Sensors record conditions, which are then sent to a computer or a network-based device.This is used to detect a movement that deviates from the intended movement sequence and to then provide the user with corrective instructions.

[0009] EP 2 153 370 B1 discloses a system for aligning prostheses, in which both movement data of the person fitted with the prosthesis and prosthesis alignment errors are determined from a movement database. These are compared to determine whether the prosthesis corresponds to a target value or requires further adjustment.

[0010] From DE 10 2012 009 507 A1 a method and a device for determining malpositions in the construction of prostheses of the lower extremities is known, wherein inertial measurement data are determined over at least one gait cycle and compared with target values.

[0011] DE 10 2018 128 514 B4 discloses a method for performing a static prosthesis assembly, wherein several components are arranged next to one another. The actual position and actual orientation of the arranged components relative to one another are determined based on recorded positions and orientations of markings and compared with corresponding target values.

[0012] The adjustment of microprocessor-controlled orthopedic devices with the corresponding settings, which ensure optimal adaptation and provision of the patient with the necessary orthopedic device, is generally based on the experience of the orthopedic technician in order to maintain a high quality of care. The best possible setting is sought in an iterative process. After each adjustment by the orthopedic technician, the patient uses the orthopedic device in everyday life and reports this back to the orthopedic technician. This adjustment process is very time-consuming and costly, especially for orthopedic technicians with little experience. The object of the present invention is therefore to provide an improved method for adjusting an orthopedic device.

[0013] The object is achieved according to the invention with the method of the type mentioned above by the features of patent claim 1. Advantageous embodiments of the invention can then be found in the corresponding subclaims.

[0014] According to claim 1, a method for adjusting a microprocessor-controlled orthopaedic device which is worn on the body of a patient equipped therewith and which influences the movement sequence by a microprocessor-controlled control of actuators is proposed, the method comprising the following computer-implemented steps:

[0015] - Providing a digital communication connection from a mobile terminal to a setting database in which at least one setting value for at least one parameter of the respective microprocessor-controlled control system as well as associated patient data of a patient equipped with the respective orthopaedic device are stored for a plurality of microprocessor-controlled orthopaedic devices,

[0016] - Calculating at least one setting value of at least one parameter of the microprocessor-controlled control of the patient's orthopaedic device depending on patient data of the patient whose microprocessor-controlled orthopaedic device is to be adjusted and / or the setting values ​​and associated patient data stored in the setting database,

[0017] - Displaying at least one calculated setting value on the mobile device in order to adjust the microprocessor-controlled orthopaedic device.

[0018] The method according to the invention initially comprises providing a digital communication connection from a mobile device to a settings database. The mobile device can be, for example, a smartphone, tablet, laptop, or PC. The digital communication connection is preferably provided using a standardized interface, for example, via a wired and / or wireless communication connection (TCP / IP, GSM, UMTS, LTE, etc.), and is in particular a network-based communication connection.

[0019] The settings database contains at least one setting value for at least one parameter for the microprocessor-controlled control of a variety of microprocessor-controlled orthopedic devices, along with the corresponding patient data of the patient equipped with the specific orthopedic device. Thus, for a specific orthopedic device, the patient data and the settings of the orthopedic device for its control are stored in the database.

[0020] The mobile device can access this settings database using the digital communication connection via a communication interface in the mobile device.

[0021] If a specific orthopaedic device is to be set for a specific patient, the optimal setting values ​​for at least one parameter of the microprocessor-controlled control of the orthopaedic device to be set are determined from the setting database depending on the patient data of this patient and the orthopaedic device used.

[0022] For this purpose, the settings of other orthopedic devices that match the orthopedic device to be configured are first determined from the settings database, along with the associated patient data. Based on the patient data of the patient whose orthopedic device is now to be configured, the optimal settings for the parameters of the orthopedic device to be configured are calculated from the settings determined from the settings database and the associated patient data. This can be done algorithmically, for example, or with the help of a previously trained knowledge database (e.g., a KL). The settings for the orthopedic device can be calculated, for example, using the settings database.The settings database comprises a data processing system that, in addition to the actual database containing the settings and patient data, also performs the calculation of the settings for the orthopedic device being adjusted. Data capacity can be saved, particularly with wireless transmission, although the execution speed on a central data processing system may be more optimal than on a low-performance device.

[0023] It is also conceivable that the settings and the associated patient data are transferred from the settings database to the mobile device, with only those patient data settings that are also used for the calculation being transmitted. Therefore, the entire contents of the database do not need to be transferred. Based on the transferred settings and patient data, the calculations are then performed on the mobile device to calculate the settings for at least one parameter for the orthopedic device to be configured.

[0024] Preferably, at least one setting value is calculated for a plurality of parameters of the microprocessor-controlled control of the orthopedic device to be adjusted. It can also be provided that multiple setting values ​​are calculated for one parameter of the microprocessor-controlled control, for example, to specify an optimal range within which the setting values ​​are all considered optimal or to specify alternative settings of the orthopedic device in conjunction with other setting values.

[0025] A setting of the orthopaedic supply comprises in particular one or more parameters, each with at least one setting value.

[0026] After the setting values ​​for the patient's orthopedic device have been calculated, the setting values ​​are displayed on the mobile device. These previously calculated setting values ​​are then used to adjust the microprocessor-controlled orthopedic device for the corresponding patient. The present invention has the advantage of making the adjustment process more time-saving and efficient, even if the orthotist has little experience. This shortens the interaction steps, thus increasing patient comfort. Furthermore, the full potential of the experience of other orthotists can be utilized, since the setting values ​​stored in the database are derived from this.

[0027] A further advantage of the present invention is that the setting values ​​become increasingly precise, like a self-learning system, as the setting values ​​individually adjusted for each patient are transferred back to the setting database. Over time, an ever-increasing number of individual setting values ​​is created in connection with the respective patient data, which are linked to the respective setting values, so that the setting values ​​for a specific patient can be calculated with increasing precision. The calculation is thus carried out as a function of time and the number of incoming parameters.

[0028] It is conceivable that not only orthopedic devices on one side of the body are considered, but also orthopedic devices on both sides. The settings for the orthopedic device on the first half of the body can influence the settings for the orthopedic device on the second half of the body to achieve an optimal result. This means that when determining the settings for the first half of the body, the settings for the second half of the body are also taken into account in patients with bilateral devices.

[0029] According to one embodiment, the patient data of the patient whose microprocessor-controlled orthopedic device is to be adjusted is transmitted from the mobile terminal to the adjustment database, wherein the at least one adjustment value of the at least one parameter is calculated by the adjustment database. According to one embodiment, the at least one adjustment value is calculated depending on those stored adjustment values ​​that relate to the same microprocessor-controlled orthopedic device or at least to the same type or kind of device.

[0030] In this way, the data stored in the settings database can be filtered to those data that relate to the orthopaedic device to be adjusted and whose parameters, for which the setting values ​​are stored in the database, correspond to those of the orthopaedic device to be adjusted.

[0031] According to one embodiment, it is provided that the at least one setting value is calculated as a function of those stored setting values ​​that are not older than a predetermined date.

[0032] In this embodiment, only setting values ​​are taken into account which, starting from the current date, are not older than a certain period of time, so that only setting values ​​are taken into account which have a certain up-to-dateness or whose first configuration is not older than the specified date.

[0033] According to one embodiment, it is provided that at least one correlation parameter is calculated by means of the setting database and transmitted to the mobile terminal, wherein even without an existing communication connection, at least one setting value is calculated depending on the patient data and the at least one correlation parameter.

[0034] The at least one correlation parameter (preferably multiple correlation parameters) is a weighting of individual parameters that are used in the calculation of the individual setting values. The correlation parameter(s) are stored on the mobile device and are updated whenever a new communication connection is established. According to one embodiment, the at least one setting value is calculated based on those stored setting values ​​for which a change was made by an orthopedic specialist that is no older than a specified change date.

[0035] In this embodiment, only setting values ​​that have been changed in the recent past by an orthopaedic technician are taken into account, so that here too only current setting values ​​or changed setting values ​​are taken into account.

[0036] By selecting the appropriate date, and ensuring that the adjustment values ​​are no older than this, the patient's current orthotic device can also be taken into account. Wearing an orthotic device typically results in changes to the patient's physical parameters in the area of ​​the orthotic device, necessitating a new adjustment. This can be taken into account by appropriately filtering the data from the adjustment database.

[0037] It is therefore also part of the core idea of ​​the present invention that only those setting values ​​from the setting database are taken into account for the calculation which are older than a predetermined date, in order to filter data which are optimally adapted to this even if the orthopaedic device has already been worn for a longer period of time.

[0038] According to one embodiment, it is provided that the at least one setting value is calculated as a function of those stored setting values ​​which relate to a microprocessor-controlled orthopaedic device which has performed a certain number of movements.

[0039] This ensures that only settings that have proven beneficial for the respective patient through a large number of movements are taken into account. Settings that record only a small number of movements of the associated orthopedic device are often perceived as disturbing by the patient, leading to adjustments and thus overwriting of the values. According to one embodiment, after the patient's microprocessor-controlled orthopedic device has been adjusted, the current settings are transmitted from the mobile device to the settings database.

[0040] This allows the newly calculated and / or slightly adjusted settings, along with the patient data of the patient whose orthopedic device is to be adjusted, to be entered into the database so that they can be taken into account in the calculations for other patients. This keeps the database up-to-date over time and approaches an optimum for the respective patient with the corresponding patient data.

[0041] According to one embodiment, the setting of the microprocessor-controlled orthopaedic device for the patient with current setting values ​​is carried out by means of the mobile terminal, which establishes a communication connection to the microprocessor-controlled orthopaedic device for this purpose.

[0042] The calculated setting values, which are displayed on the mobile device and may have been slightly adjusted by the orthotist, are then transferred to the microprocessor-controlled orthotist via a communication connection. The entire adjustment process can thus be carried out using the mobile device, starting from the provided communication connection to the adjustment database, through the calculation of the setting values, to the communication connection with the orthotist, and finally the adjustment of the device, without any media disruption during the entire adjustment process.

[0043] According to one embodiment, it is provided that a machine learning system (as part of the settings database) is provided which has learned a correlation of patient data from patients and information about their respective microprocessor-controlled orthopedic devices as input data with relevant setting values ​​of at least one parameter as output data, wherein in order to calculate the at least one setting value for setting the microprocessor-controlled orthopedic device of the patient, the patient data of the patient and information about his microprocessor-controlled orthopedic device are entered into the machine learning system as input data and then at least one calculated setting value is received as output data.

[0044] Preferably, such a machine learning system is an artificial neural network.

[0045] The machine learning system has learned a correlation between the patient's patient data and information about their orthopedic device, along with settings for this orthopedic device. The machine learning system is part of the settings database and part of the calculation.

[0046] The training data originates from the settings stored in the settings database, along with the associated patient data and information about the orthopedic device to which the settings and patient data belong. A training dataset thus comprises information about the orthopedic device and a selection of patient data (e.g., age, weight, duration of treatment, etc.), as well as the specific settings for this orthopedic device. Such a training dataset is created for each patient who is provided with an orthopedic device, so that across all patients, a large number of such training datasets are available, which can then be used to train the machine learning system in a known manner.

[0047] The inventive concept also encompasses a computer program with program code means configured to carry out the method described above when the computer program is executed on a data processing system.

[0048] The inventive concept also encompasses a system comprising a settings database and one or more mobile terminals, wherein the system is configured to carry out the method described above. A data processing system can be provided on which the settings database is executed. The calculation for specific setting values ​​can also be performed on this data processing system, as can, if necessary, the machine learning system, which performs a K1-based calculation.

[0049] The invention is explained by way of example with reference to the attached figure. It shows:

[0050] Figure 1 schematic representation of the system and method according to the invention

[0051] Figure 1 shows, in a highly simplified schematic representation, an orthopedic technician 10 or an orthopedic technician operating a mobile terminal 11 to adjust a microprocessor-controlled orthopedic device 100. This orthopedic device 100 corresponds to an orthopedic device for a patient (not shown).

[0052] Patient data of the patient who is to use the orthopedic device 100 is stored on the terminal device 11. Such patient data can be stored locally on the terminal device 11 or, if necessary, on network-capable databases (cloud). Furthermore, information about the orthopedic device 100 is stored on the terminal device 11 in order to distinguish it with regard to its use, type, and production series.

[0053] The patient data can include, for example, the patient's height and weight, as well as the impairment to be addressed with the orthopedic device 100. The patient data can also include the patient's age and, if applicable, a movement profile, i.e., whether the patient is very active in sports or tends to be less active. Clinical patterns and the history of the impairment or other diseases can also be part of the patient data, which are taken into account when determining the settings for the orthopedic device 100.

[0054] Both the patient data and the information about the orthopaedic technical supply 100 are now transmitted by the orthopaedic technician 10 by means of the terminal 11 to a data processing system 20 accessible via a communication connection 12 of a network.

[0055] The data processing system has a settings database 21 and a calculation unit 22. Using the patient data and the information about the orthopedic device 100 whose parameters are to be adjusted, the settings values ​​corresponding to the orthopedic device 100 are determined from the settings database 21. This means that only those data from the settings database are taken into account whose settings and patient data belong to an orthopedic device that corresponds to the orthopedic device 100 to be adjusted.

[0056] In the exemplary embodiment of Figure 1, a knee prosthesis is to be adjusted as an orthopedic device 100, in which an artificial knee is provided, the behavior of which can be adjusted using corresponding adjustment parameters. Furthermore, only those adjustment values ​​are determined from the database 21 that also relate to a knee prosthesis with an artificial knee of the intended type.

[0057] Additional filter parameters can be specified, such as the date of initial configuration and / or the date of the last change. This ensures that the most up-to-date data is always used.

[0058] From these setting values ​​determined from the setting database 21 for various orthopedic devices in the field, a setting value is now determined for at least one parameter of the orthopedic device 100, taking into account the patient data of the patient to be treated and the patient data in the database that belong to the setting values. Preferably, however, several parameters are determined for the orthopedic device 100.

[0059] The calculation of the setting values ​​for the orthopedic supply 100 is carried out with the aid of the calculation unit 22. In one embodiment, the calculation unit 22 can form a common unit integral with the setting database 21, in which a machine learning system (for example a KL) is provided in which both the calculation and the data storage form an integral unit.

[0060] By entering the information about the orthopedic device 100 and the patient data, the setting values ​​can then be determined based on the learned correlation for one or more parameters of the orthopedic device 100. It can be provided that a separate machine learning system is provided for each type of orthopedic device.

[0061] The setting values ​​thus determined by the data processing system 20 are then transmitted to the terminal device 11, where they are displayed. These setting values ​​shown on the display are then used to adjust the orthopedic device 100 accordingly.

[0062] For this purpose, it can be provided that a further communication connection 13 is established from the mobile terminal 11 to the orthopaedic device 100 in order to electronically transmit the setting values ​​determined and, if necessary, adjusted by the orthopaedic technician 10 to the orthopaedic device 100.

[0063] List of reference symbols

[0064] 10 orthopedic technicians

[0065] 11 mobile device 12 communication connection with the database

[0066] 13 Communication link with the orthopaedic technical supply

[0067] 20 data processing system

[0068] 21 Settings database

[0069] 22 Calculation unit 100 orthopaedic technical supplies

Claims

Patent claims 1. A method for adjusting a microprocessor-controlled orthopaedic device (100) which is worn on the body of a patient equipped therewith and which influences the movement sequence by a microprocessor-controlled control of actuators, the method comprising the following computer-implemented steps: - Providing a digital communication connection (12) from a mobile terminal (11) to a setting database (21) in which at least one setting value for at least one parameter of the respective microprocessor-controlled control and associated patient data of a patient equipped with the respective orthopaedic supply (100) are stored for a plurality of microprocessor-controlled orthopaedic supplies (100), - Calculating at least one setting value of at least one parameter of the microprocessor-controlled control of the patient's orthopaedic device (100) as a function of patient data of the patient whose microprocessor-controlled orthopaedic device (100) is to be adjusted and / or the setting values ​​and associated patient data stored in the setting database (21), - Displaying the at least one calculated setting value on the mobile terminal (11) in order to adjust the microprocessor-controlled orthopaedic device (100).

2. Method according to claim 1, characterized in that the patient data of the patient whose microprocessor-controlled orthopaedic supply (100) is to be adjusted are transmitted from the mobile terminal (11) to the adjustment database (21), wherein the at least one adjustment value of the at least one parameter is calculated by the adjustment database (21). Method according to claim 1 or 2, characterized in that the at least one setting value is calculated as a function of those stored setting values ​​that relate to the same microprocessor-controlled orthopedic device (100) or at least to the same type or kind of device. Method according to one of the preceding claims, characterized in that the at least one setting value is calculated as a function of those stored setting values ​​that are not older than a predetermined date. Method according to one of the preceding claims, characterized in that the at least one setting value is calculated as a function of those stored setting values ​​that relate to a microprocessor-controlled orthopedic device (100) that has performed a certain number of movements.Method according to one of the preceding claims, characterized in that the at least one setting value is calculated as a function of those stored setting values ​​for which a change was made by an orthopedic specialist and which is not older than a predetermined date. Method according to one of the preceding claims, characterized in that at least one correlation parameter is calculated by means of the setting database (21) and transmitted to the mobile terminal (11), wherein at least one setting value is calculated as a function of the patient data and the at least one correlation parameter even without an existing communication connection (12). Method according to one of the preceding claims, characterized in that after the microprocessor-controlled orthopedic device (100) of the patient has been adjusted, the current setting values ​​are transmitted from the mobile terminal (11) to the setting database (21).Method according to one of the preceding claims, characterized in that the microprocessor-controlled orthopaedic supply (100) of the patient is set with current setting values ​​by means of the mobile terminal (11), which for this purpose establishes a communication connection (13) to the microprocessor-controlled orthopaedic supply (100).Method according to one of the preceding claims, characterized in that a machine learning system is provided which has learned a correlation of patient data and information about their respective microprocessor-controlled orthopedic devices (100) as input data with corresponding setting values ​​of at least one parameter as output data, wherein, in order to calculate the at least one setting value for adjusting the patient's microprocessor-controlled orthopedic device (100), the patient data of the patient and information about their microprocessor-controlled orthopedic device (100) are entered into the machine learning system as input data, and then at least one calculated setting value is obtained as output data. Method according to claim 10, characterized in that the machine learning system is an artificial neural network.A computer program with program code means configured to carry out the method according to one of the preceding claims when the computer program is executed on a data processing system (20). A system comprising a settings database (21) and one or more mobile terminals (11), the system being configured to carry out the method according to one of claims 1 to 11.