METHOD FOR SETTING UP AN ORTHOPEDIC DEVICE

Description

[0001] The invention relates to a method for the computer-based setup of an orthotic device worn on the body of a patient equipped with it. The invention also relates to a computer program for this purpose.

[0002] Orthopedic devices, as defined in the present invention, are in particular orthoses, prostheses, exoskeletons, and, where applicable, wheelchairs, as well as the associated seat shells and seat cushions, which are individually adapted to the user. Orthoses are products that support, protect, or restrict the movement of a part of the patient's body, for example, a joint, in order to prevent overuse. Prostheses, on the other hand, replace missing or no longer present parts of the patient's body. Exoskeletons are, in particular, mechanical support structures designed to support, protect, or stabilize the patient's main musculoskeletal system.

[0003] In the following, the term "patient" refers to any user of the orthotic device. Therefore, it refers to the wearer of the orthotic device.

[0004] An orthotic device is typically attached to a part of the patient's body. It does not necessarily have to be in direct contact with the patient's skin. Orthoses and exoskeletons, for example, are often worn over clothing, so that the clothing, such as trousers, is positioned between the orthotic device and the patient's skin. Nevertheless, a knee brace, for instance, is attached to the patient's knee or leg. A prosthesis always has an interface element that connects to an amputation stump or another body part and is attached to that part. For example, a prosthetic socket is used for a leg prosthesis, forming the interface between the prosthesis and the amputation stump. In this case, the amputation stump would be the patient's body part.A liner is usually used between the skin surface of the patient's amputation stump and the prosthetic socket to reduce shear forces acting on the skin.

[0005] A prosthetic socket for an amputation stump is typically made of a rigid (virtually non-deformable) material, such as fiber-reinforced plastic, and forms an important part of the interface between the amputation stump and the prosthesis, which is attached to the socket. Such prosthetic sockets have long been used, particularly for leg prostheses intended for use on an amputation stump, such as a thigh stump.

[0006] Prosthetic sockets for leg amputees are subject to particular stresses in daily use. When walking, the patient's entire weight rests on the prosthetic socket, and thus especially on the residual limb, which is positioned within the socket. It is therefore of utmost importance to adapt the prosthetic socket as optimally as possible to the individual characteristics and needs of the patient, particularly to the shape and geometry of the affected body part, taking into account the different movement situations such as walking, standing, and sitting down.

[0007] Both during the setup and adjustment of an orthotic device, the patient is supported by a specialist, usually a technically trained professional, such as an orthotist. With their knowledge and experience, the orthotist can make the necessary adjustments to ensure the orthotic device fits optimally and promotes a comfortable and natural gait.

[0008] From EP 2 153 370 B1, a system for aligning prostheses is known in which both movement data of the person equipped with the prosthesis and prosthesis alignment errors are determined from a movement database. These are compared with each other to determine whether the prosthesis corresponds to a target value or needs further adjustment.

[0009] From DE 10 2012 009 507 A1 a method and a device for determining malpositions in the construction of prostheses of the lower extremities are known, wherein inertial measurement data are determined over at least one gait cycle and compared with target values.

[0010] German patent application DE 10 2018 128 514 B4 discloses a method for performing a static prosthesis assembly, in which several components are arranged next to each other. The actual position and orientation of the arranged components relative to each other are determined based on recorded positions and orientations of markings and compared with corresponding target values. Only the components themselves are compared, without taking the individual patient's situation into account.

[0011] When setting up an orthotic device, which includes the assembly and selection of an orthotic device, the adaptation of an existing orthotic device, and the adjustment of its parameters, it must be ensured that the orthotic device is set up in such a way that no negative effects occur on other parts of the body or the body as a whole. The setup may also include the automatic adaptation and / or creation of individualized manufacturing data for the orthotic device, for example, for subsequent additive manufacturing.

[0012] US Patent 2021 / 069984 A1 discloses the creation of an orthotic device. This process begins with the provision of patient data, from which a patient model is then determined or generated. Patient parameters are derived from this model, and based on these parameters, a virtual representation of the orthotic device is created using device parameters. Patient or device parameters can then be adjusted to observe the effect of the change on the visual representation. These changes are made by a user, such as an orthotist, and the corresponding orthotic device is then manufactured based on the completed model.

[0013] From GIORGIO COLOMBO ET AL: "A digital patient for computer-aided prosthesis design", INTERFACE FOCUS, Vol. 3, No. 2, April 6, 2013 (2013-04-06), page 20120082, x9055671164, GB ISSN: 2042-8898, DOI: 10.1098 / rsfs.2012.0082, the computer-aided creation of a prosthesis is known. For this purpose, a digital patient is first created based on patient data, which is represented by an avatar for visualization. Using appropriate models, the residual limb to be fitted is also created. With the help of a model framework, a corresponding prosthesis model is then created, taking the modeled residual limb into account. Among other things, the prosthesis socket is also automatically generated.

[0014] Patent KR20200013157A discloses the production of a customized ankle or foot orthosis. First, the shape and size of the patient's leg are measured. Then, an orthosis adapted to this leg is modeled, and the patient's gait is simulated. Based on this gait simulation, pressure points are identified, where additional padding is then added. The orthosis can then be manufactured using a 3D printer.

[0015] US patent 2018 / 0243155 A1 discloses the creation of an exoskeleton. First, a body scan of the patient who will wear the exoskeleton is performed. Then, based on the body scan, a complete 3D surface model of the patient is created. This surface model is then used to adapt the exoskeleton to it, or to create a corresponding exoskeleton adapted to this surface model.

[0016] Finally, US2017 / 360578 A1 also reveals the creation of a prosthesis or an orthosis, whereby a body model is created first.

[0017] Against this background, the object of the present invention is to propose an improved method for setting up an orthopaedic device.

[0018] The problem is solved by the method for setting up an orthopaedic device according to claim 1, as described in the invention. Advantageous embodiments of the invention are described in the corresponding dependent claims.

[0019] According to claim 1, a method for computer-based setup of an orthopaedic device worn on the body of a patient equipped therewith is proposed, wherein the method comprises the following steps performed or executable by a data processing system: Providing a digital body model; providing body-related patient parameters for the provision of an orthotic device to the patient; providing a digital orthotic treatment proposal that includes the provision of an orthotic device to the patient and related treatment parameters; simulating the provision of an orthotic device to the patient on the body model with the orthotic treatment proposal, taking into account the provided body-related patient parameters, using a simulation device, whereby an interaction between the body model and the orthotic treatment proposal is determined based on the simulation using an evaluation unit;and determining an optimized orthotic and prosthetic treatment proposal based on the already provided orthotic and prosthetic treatment proposal, depending on the determined interaction, using the evaluation unit.

[0020] According to the invention, it is proposed that the orthotic fitting of the patient is simulated on the provided digital body model using the provided orthotic fitting proposal, whereby the provided body-related patient parameters are taken into account during the simulation of the orthotic fitting proposal. The simulation determines an interaction between the body model and the fitting proposal and can thus determine the effects of the provided fitting proposal on the digital body model. This allows it to be determined, even before the patient is fitted with the fitting proposal, what effects the fitting proposal with the proposed setting parameters could or will have on the patient.

[0021] Based on the identified interaction between the digital body model and the digital treatment proposal, the evaluation unit of the data processing system now generates an optimized orthotic treatment proposal. This optimized proposal is determined, for example, by adapting or modifying the original treatment proposal. The optimized orthotic treatment proposal includes, in particular, measures for setting up the physical orthotic device in such a way that the treatment goal is achieved in the best possible way, while also minimizing, reducing, or completely avoiding negative effects on the patient's body.

[0022] Once the evaluation unit has determined an optimized orthotic and prosthetic treatment proposal, it can be displayed on a screen of the data processing system. The specialist can then, if necessary, initiate another simulation run until a maximally optimized orthotic and prosthetic treatment proposal is achieved from the specialist's perspective.

[0023] Based on an optimized orthotic device proposal determined by the process, the patient's orthotic device is now set up so that it can be worn on the patient's body. The patient's orthotic device is therefore set up as suggested by the optimized orthotic device proposal from the simulation.

[0024] This makes it possible for the first time to determine negative effects on the patient's body when setting up an orthotic device without the patient, so that the patient can be fitted with an optimally configured orthotic device.

[0025] The provided digital body model can be a generic body model that is individualized by the patient's body-related parameters. In particular, the body model can be a digital (standardized) anatomical body model.

[0026] According to one embodiment, the optimized orthotic treatment proposal is used as the basis for a renewed simulation of the orthotic treatment.

[0027] The optimized treatment plan identified through the simulation is then used as the basis for a subsequent simulation. This involves applying the measures for setting up the orthotic device contained in the optimized plan to the previously provided treatment plan that formed the basis of the simulation. This allows the simulation to iteratively approach an optimum (global or local) and deliver the best possible result.

[0028] According to one embodiment, the provided orthopaedic supply proposal is automatically generated beforehand using a computing unit, depending on at least some of the patient's body-related parameters.

[0029] Based on patient parameters, which may also include pathological information, the processing unit can automatically generate an orthotic and prosthetic recommendation, for example, using the patient's biometric data previously provided to the unit. Thus, for instance, with knowledge of relevant amputation information, a recommendation for a suitable prosthesis can be generated, tailored to the patient's biometric parameters and the information they contain.

[0030] A database or machine learning system can contain predefined treatment proposals for various combinations of patient parameters. Based on specific patient parameters, one of these predefined treatment proposals is selected and used as the basis for the simulation. The system can also be configured to adjust the predefined treatment proposal based on the patient parameters before the simulation.

[0031] According to one embodiment, the digital body model is designed to model at least a part of the human skeletal system, and if necessary, at least one joint function thereof.

[0032] It may be planned that, in addition to simulating joint function, a simulation of the muscles, tendons and ligaments is also carried out, and if necessary, their control by the nerves, which may be particularly relevant due to medical limitations.

[0033] According to one embodiment, the digital body model is adapted to the patient depending on at least some of the patient's body-related parameters and / or the digital body model is individualized based on measurement data from a previously performed measurement of the patient's physical body.

[0034] The digital body model can be provided as a generic model and adapted to the patient's specific characteristics using their body-related parameters. Alternatively, the digital body model can be individually customized based on measurement data from a previously performed survey, allowing for an even more accurate representation of the patient in the simulation. This survey can consist of taking individual measurements from the patient or a partial or complete 3D scan. Ideally, as much information as possible should be provided, even beyond the area being treated, such as information about body parts not directly affected by the proposed treatment (e.g., adjacent joints).

[0035] According to one embodiment, determining an optimized orthopaedic supply proposal includes changing the supply parameters of the orthopaedic supply model and / or selecting the orthopaedic supply model.

[0036] The treatment proposal can therefore include measures that modify the treatment proposal underlying the simulation in such a way as to minimize, reduce, or completely avoid negative interactions on specific body parts or the patient's entire body, while simultaneously achieving the treatment goal in the best possible way. Such measures can, for example, involve adjusting specific parameters with which the orthotic device can be configured. In the case of (microprocessor-controlled) prostheses, this includes, for example, specific damping properties, angular positions, or similar measures. The more complex the prosthesis, the more parameters can typically be modified, which, particularly with microprocessor-controlled prostheses, can also be automated by the software.

[0037] However, the optimized treatment proposal may also include measures involving the selection of a specific orthotic device model. For example, based on the simulated interactions and their resulting impact on the patient's body, it may be necessary to change the underlying orthotic device model and replace it with a different model, such as one of a different type.

[0038] According to one embodiment, it is provided that a static load case is simulated with the simulated orthopaedic device, whereby pressure points, contact points, contact surfaces and / or deviations of the overall structure from a predetermined structure of the orthopaedic device are determined as an interaction between the body model and the orthopaedic device proposal.

[0039] In a static load case, the orthotic device is subjected to stress while remaining stationary, experiencing a static force. This is particularly relevant when standing, sitting, or lying down. Simulating a static load case allows for the identification of interactions between the body model and the proposed static treatment plan, such as pressure points and contact points that could cause the patient pain. Based on this analysis, an optimized treatment plan can be developed, incorporating measures to alleviate these pressure points and contact points, thereby increasing patient comfort or correcting existing joint misalignments. This is also crucial to prevent compensatory postures.

[0040] According to one embodiment, the simulation involves simulating a dynamic load case with the simulated orthotic device, in which a specific movement or sequence of movements is simulated using the orthotic device, whereby the interaction between the body model and the orthotic device proposal determines the load on the affected joints, the range of motion and / or the deviation between the simulated movement and a predetermined optimal movement or between the simulated sequence of movements and a predetermined optimal sequence of movements.

[0041] In the dynamic load case, a movement or movement sequence is simulated, and the interaction between the body model and the proposed treatment plan is determined. This particularly concerns the load on the affected joints, the range of motion, and deviations from an optimal movement pattern. Based on the interactions identified and their negative effects on the patient's body, a corresponding, optimized treatment plan can then be developed, including measures to mitigate or prevent these negative effects.

[0042] According to the invention, it is provided that, as an interaction between the body model and the orthopaedic treatment proposal, an effect of a static or dynamic load case with the simulated orthopaedic treatment on at least one joint is determined, which is different from the directly treated joint and / or which is provided within a load case-related joint chain of the body model.

[0043] The interaction between the body model and the treatment proposal therefore considers not only the directly treated joint, but also those joints that are different from it or that are part of a load-related joint chain. For example, when simulating a knee orthosis, it may be necessary to also consider the effects on the hip joint or the spine if an optimized treatment proposal is to be developed. Joints in a joint chain are those joints that, starting from the treated or replaced joint, are significantly involved in and necessary for the movement sequence.

[0044] In addition to load-related interactions between the orthotic device and the body model, other interactions can also be considered, such as the controllability of the device by the remaining muscle strength. Particularly with EMG-controlled prostheses or orthoses, the interaction between muscle signals from the model and the sensors of the device can be examined in order to optimally align the sensors.

[0045] According to one embodiment, the optimized orthopaedic treatment proposal includes at least one measure on a body part and / or joint other than the one directly being treated.

[0046] The optimized orthotic treatment proposal may therefore also include measures relating to other body parts or joints in order to mitigate or prevent the negative effects on the patient's body resulting from the simulated interaction between the body model and the treatment proposal.

[0047] In another embodiment, it is conceivable to compare a generic body model without parameterization by patient parameters with a generic body model with parameterization by patient parameters. In this process, a simulation is performed using the provided orthotic treatment proposal with respect to the generic body model without parameterization, and a simulation is performed using the provided orthotic treatment proposal with respect to the generic body model with parameterization. Both simulations are then compared, and the interaction is determined based on this comparison in order to identify an optimized orthotic treatment proposal.

[0048] The invention is explained by way of example with reference to the attached figures. They show: Figure 1: Schematic representation of the method in relation to the executing data processing system; Figure 2: Schematic representation of a generic body model in the form of an avatar; Figure 3: Schematic representation of a static simulation in a first embodiment; Figure 4: Schematic representation of a static simulation in a second embodiment; Figure 5: Schematic representation of a dynamic simulation.

[0049] Figure 1 Figure 1 shows a highly simplified schematic representation of a data processing system 10, which has a simulation unit 11 and an evaluation unit 12. The simulation unit 11 and the evaluation unit 12 can represent software modules that run on the data processing system 10 and interact with each other to execute the procedure described above.

[0050] The data processing system 10 is first provided with a digital body model 20, which can, for example, be a generic body model. Furthermore, corresponding body-related patient parameters 21 are provided to the data processing system 10, relating to specific physical characteristics of the patient. The generic digital body model 20 can then be supplemented with the provided body-related patient parameters 21 so that, in conjunction with the patient parameters, the body model represents the patient's body.

[0051] Finally, a digital orthopaedic supply proposal 22 is provided to the data processing system 10, which is to be simulated in connection with the body model and the patient parameters.

[0052] The body model 20, the patient parameters 21 and the care proposal 22 can also be provided to the data processing system 10 via a database in which the individual data are stored.

[0053] Using the simulation device 11, the provided orthotic treatment proposal 22 is simulated on the body model 20 with the parameterized patient parameters 21, whereby both a static and a dynamic load case can be simulated. Based on this simulation, the evaluation unit 12 then determines an interaction between the body model and the treatment proposal in order to determine an optimized orthotic treatment proposal 23.

[0054] Figure 2Figure 1 shows a schematic representation of a digital body model 20, depicted in a side view on the left and a frontal view on the right. The digital body model 20 is in Figure 2 The digital body model is represented in the form of a generic body model and specifically includes the joints and body parts necessary for movement. The digital body model 20 is implemented in such a way that it has corresponding movement restrictions for each joint in order to model human movement.

[0055] Figure 3 Figure 1 shows an example of how an orthotic treatment proposal is determined based on the simulation. The body model 30, which is parameterized according to the patient's parameters, is shown on the left.

[0056] The patient suffers from both a left bowleg and a leg length discrepancy. This patient data, in the form of patient parameters, is fed into the generic body model 20 in order to determine that the Figure 3 To create a visible patient-specific body model 30 (left illustration). It can be seen that corresponding symptoms occur in the left knee, the left hip joint, and the cervical spine during a simulation.

[0057] The central view shows the body model 30, which is equipped with a treatment proposal 31 for the treatment of bowlegs. This combination of patient-specific body model 30 and the treatment proposal 31 equipped with it is now simulated using static simulation in order to determine the interaction of this treatment proposal 31 with the rest of the patient's body.

[0058] This is characterized in the middle view by the fact that the patient is likely to continue experiencing discomfort in both the left hip joint and the cervical spine area even with the proposed treatment option 31.

[0059] Through the simulation and the associated evaluation of the simulation, the evaluation unit determines that the treatment proposal 31 has indeed resolved the complaints in the left knee, but not the complaints in the left hip joint and in the cervical spine area resulting from the leg length discrepancy.

[0060] The resulting optimized orthotic treatment plan therefore includes measures to compensate for the leg length discrepancy. Specifically, the optimized treatment plan recommends using size 32 insoles to alleviate the patient's symptoms.

[0061] The optimized orthotic treatment proposal therefore provides to replace the knee orthosis 31 with insoles 32 in order to address both the O-leg-related malposition of the left knee and the complaints in the left hip joint and in the cervical spine area.

[0062] Figure 4Figure 1 shows an exemplary embodiment in which the body model 30 on the left side has again been parameterized with the patient parameters. In the middle view, the patient was simulated on the body model with a treatment proposal 31, showing the patient once in a side view and once in a top view. The simulation shows that while the static load cases are unremarkable, a compensatory movement of the hip and spine occurs in the dynamic load case. In the case shown here, the orthosis's simulation of the toe push-off leads to hyperextension of the knee. The hip is rotated posteriorly on the affected side as a compensatory movement. This further leads to an unwanted rotation in the spine and potential long-term damage to the intervertebral bodies.This is hardly noticeable, if at all, when examining the affected area locally and would therefore lead to unfavorable care for the patient.

[0063] The optimized orthotic treatment proposal can then involve adjusting treatment proposal 31 accordingly so that the existing compensatory movement of the hip and spine no longer occurs. For this purpose, appropriate parameters can be set on the simulated orthotic device, which then alleviates the symptoms. In the present example, a slight flexion of the lower leg could be set, reducing the corrective effect of the orthosis and preventing overcorrection. Alternatively, the heel of the orthosis could be raised. Another alternative would be the use of a softer or shorter footplate, which would shorten the anterior lever arm and positively influence the dynamics. The system can compare the different alternatives and also test them in further simulation rounds.For example, it could be determined that while adjusting sales volume further improves the static case, it does not provide a solution for the problems in the dynamic case and should therefore be rejected.

[0064] Figure 5 Figure 1 shows an embodiment in which a dynamic load case is simulated on a parameterized body model 30 with a treatment proposal 31. The left view shows that the provided treatment proposal 31, with its set parameters, overcorrects, resulting in discomfort in the knee, hip joint, and spine.

[0065] On the right side, an optimized treatment proposal 31 can be seen, which no longer shows any negative interactions in the dynamic load case. The optimized orthotic treatment proposal may include measures that recommend correcting the set parameters of treatment proposal 31 in order to mitigate overcorrection. Reference symbol list

[0066] 10 Data processing system 11 Simulation device 12 Evaluation unit 20 Digital body model 21 Patient parameters 22 Provided digital orthotic treatment proposal 23 Optimized orthotic treatment proposal 30 Parameterized body model 31 Digital treatment proposal

Claims

1. A method for computer-based setup of an orthopedic device wearing on the body of a patient equipped with it, the method comprising the following computer-implemented steps: - providing a digital body model (20); - providing body-related patient parameters (21) for the care of the patient with an orthopedic device; - providing a digital orthopedic care proposal (22) comprising an orthopedic care model and care parameters related thereto for the care of the patient; - simulating orthopedic care for the patient on the body model (20) with the orthopedic care proposal (22), taking into account the provided patient-related body parameters (21), using a simulation device (11), - wherein, based on the simulation, an interaction between the body model (20) and the orthopedic care proposal (22) is determined using an evaluation unit (12), and - determining an optimized orthopedic care proposal (23) based on the orthopedic care proposal (22) already provided, depending on the interaction determined by means of the evaluation unit (12), characterized in that the interaction between the body model and the orthopedic care proposal (22) is determined as the effect of a static or dynamic load case with the simulated orthopedic care on at least one joint which is different from a directly cared joint and / or which is provided within a load case-related joint chain of the body model (20).

2. Method according to claim 1, characterized in that the optimized orthopedic care proposal (23) is used as the basis for a new simulation of the orthopedic care.

3. Method according to claim 1 or 2, characterized in that the provided orthopedic care proposal (22) is automatically generated in advance as a function of at least one part of the body-related patient parameters (21) by means of a computing unit.

4. Method according to one of the preceding claims, characterized in that the digital body model (20) models at least a part of the human skeletal system, and, if necessary, at least one joint function thereof.

5. Method according to one of the preceding claims, characterized in that the digital body model (20) is or becomes adapted to the patient depending on at least a part of the body-related patient parameters (21) and / or that the digital body model (20) is or becomes individualized on the basis of measurement data from a previously performed measurement of the physical patient body.

6. Method according to one of the preceding claims, characterized in that determining an optimized orthopedic care proposal (23) comprises changing the care parameters of the orthopedic care model and / or selecting the orthopedic care model.

7. Method according to one of the preceding claims, characterized in that during the simulation, a static load case is simulated with the simulated orthopedic care, whereby the interaction between the body model and the orthopedic care proposal (22) is determined as pressure points, contact points, contact surfaces, and / or deviations of the overall structure from a predetermined structure of the orthopedic care.

8. Method according to one of the preceding claims, characterized in that during the simulation, a dynamic load case is simulated with the simulated orthopedic care, in which a specific movement or a specific sequence of movements is simulated with the orthopedic care, whereby the interaction between the body model (20) and the orthopedic care proposal (22) is determined as a load on the affected joints, a range of motion, and / or a deviation between the simulated movement and a specified optimal movement or between the simulated movement sequence and a specified optimal movement sequence.

9. Method according to one of the preceding claims, characterized in that the optimized orthopedic care proposal (23) contains at least one measure on a body part and / or joint other than the one directly cared.

10. Computer program with program code means set up to carry out the method according to one of the preceding claims when the computer program is executed on a data processing system (10).