COMPUTER-IMPLEMENTED METHOD AND SYSTEM FOR PRODUCING AN ORTHOPEDIC DEVICE

Abstract

The invention relates to a computer-implemented method for producing an orthopedic device. The method includes receiving at least one data set with patient data, processing the patient data in order to create a patient model, using the patient model to determine patient parameters, and generating a virtual representation of the orthopedic device while using the patient parameters and device parameters. The method further includes receiving at least one input from at least one user, modifying at least one of the patient parameters or device parameters on the basis of the input, and physically creating the orthopedic device.

Claims

1-12. (canceled)

13. A method for producing an orthopedic device, in particular, an orthosis or prosthesis, comprising: receiving at least one data set with patient data; processing the patient data in order to create a patient model; using the patient model to determine patient parameters; generating a virtual representation of the orthopedic device using the patient parameters and device parameters; receiving at least one input from at least one user; modifying at least one of the patient parameters or the device parameters on the basis of the input; and physically creating the orthopedic device making use of at least one of the device parameters, the patient parameters, or a model of the orthopedic device that is generated on the basis of the patient parameters.

14. The method of claim 13, wherein: physically creating the orthopedic device makes use of the device parameters, the patient parameters, and a model of the orthopedic device that is generated on the basis of the patient parameters.

15. The method of claim 13, wherein: modifying at least one of the patient parameters or the device parameters comprises controlling at least one production machine, in particular at least one 3D printer.

16. The method of claim 13, further comprising: generating a virtual representation of the patient model, and wherein, in generating the virtual representation of the orthopedic device, the orthopedic device is represented together with the patient model, in particular making use of a web server.

17. The method of claim 13, further comprising: aligning a virtual representation of the patient model relative to the virtual representation of the orthopedic device.

18. The method of claim 13, wherein: the patient parameters comprise parameters that specify at least one of a neck circumference or a shoulder width.

19. The method of claim 13, wherein: the device parameters comprise at least one design parameter or at least one functional parameter, the at least one functional parameter including a material thickness or a material flexibility, and the at least one design parameter including a color of the orthopedic device.

20. The method of claim 13, wherein the step of receiving at least one input from at least one user comprises receiving at least one first input from a first user, in particular, a doctor or a prosthetist/orthotist, and further comprising modifying at least one of the patient model or at least one of the patient parameters on the basis of the at least one first input.

21. The method of claim 20, wherein the step of receiving at least one input from at least one user further comprises receiving at least one second input from a second user, in particular, a patient, and further comprising modifying at least one of the device parameters on the basis of the second input.

22. The method of claim 13, further comprising at least one of: authenticating a first user before reception of a first input of the first user; or authenticating a second user before reception of a second input of the second user.

23. The method of claim 21, further comprising: searching in an authorization database as to which of the device parameters are amendable by the second user; and displaying, for modification, only the device parameters that are amendable by the second user according to the authorization database.

24. The method of claim 21, wherein the patient data comprises contact data of a patient, the method further including: electronically transmitting a message with a uniform resource locator (URL) to the patient, making use of the contact data; and authenticating the patient, making use of at least one of the contact data or the patient parameters, such that the patient can undertake at least one input as a user, in particular as the second user.

25. A non-transitory computer-readable medium embodying a computer program, the computer program comprising computer readable program code that when executed causes at least one computer unit to: receive at least one data set with patient data; process the patient data in order to create a patient model; use the patient model to determine patient parameters; generate a virtual representation of an orthopedic device using the patient parameters and device parameters; receive at least one input from at least one user; modify at least one of the patient parameters or the device parameters on the basis of the input; and physically create the orthopedic device making use of at least one of the device parameters, the patient parameters, or a model of the orthopedic device that is generated on the basis of the patient parameters.

26. A system for producing an orthopedic device, in particular, an orthosis or prosthesis, comprising: a design server that comprises: at least one digital interface for receiving a data record with patient data; at least one database with training data for creating a patient model on the basis of the patient data and the training data; at least one computer unit for generating 3D data of the orthopedic device; and a visualization apparatus, in particular a web server, that is configured to display the 3D data as a virtual representation of the orthopedic device and to receive at least one input from at least one user, wherein the computer unit uses the input in order to: modify at least one of device parameters or patient parameters, and on the basis of the device parameters and the patient parameters, generate production data for physical creation of the orthopedic device.

Description

IN THE DRAWINGS

[0047] FIG. 1 individual components of a system for producing an orthopedic device;

[0048] FIG. 2 elements of the production server of FIG. 1;

[0049] FIG. 3 individual method steps for producing an orthopedic device;

[0050] FIG. 4 example of a foot prosthesis obtained according to the invention; and

[0051] FIG. 5 visualization according to the invention of the foot prosthesis of FIG. 4.

DETAILED DESCRIPTION

[0052] In the following description, the same reference signs will be used for the same and similarly acting parts.

[0053] FIG. 1 shows some of the components that communicate with one another in the course of the production method according to the invention. This involves a CPO computer 10, a patient computer 100, a production server 50 and a design server 20. All of these components can communicate via a network, connected to one another in the described exemplary embodiment via the internet 1.

[0054] The CPO computer 10 comprises an optical scanner 12 for acquisition of the surface structure of a patient. This results in raw data (ScanData).

[0055] In the described exemplary embodiment, the production server 50 has a 3D printer 52 and thus can produce any desired orthosis, insofar as the necessary data is provided by the design server 20.

[0056] The individual components of the design server 20 will now be described in greater detail by reference to FIG. 2. The design server 20 has a computer unit 24, which at least partially implements the method described below. In addition, a design interface 23 is provided for communication with the already described CPO computer 10 and the patient computer 100. In a preferred exemplary embodiment, this communication takes place via a web server 40, so that the computers 10, 100 do not need any software of their own for communication with the design server 20. Thus, the services provided by the design server 20 can be accessed by means of a web browser.

[0057] In addition, a database 25 is provided. This database 25 can supply necessary model data so that the design server 20 can produce models of the orthosis. Furthermore, templates or parameters which enable an individual patient model to be made can be saved in the database 25. The database 25 can further contain authentication information in order to administer access to the design server 20, in particular, to the services offered thereby.

[0058] As can be seen from FIG. 3, the design server 20 receives the raw data acquired by the certified prosthetist/orthotist by means of a CPO computer 10. This raw data ScanData can be provided, for example, in the DICOM format. In a pre-processing step 210, a surface network of the patient MeshData and bone data SkelData are obtained from the raw data. The surface network MeshDataMeshcan be generated as a triangular network, for example, in STL format. In order to obtain the surface network MeshData, surface points are extracted from the raw data ScanData, and the point cloud obtained is embedded in a corresponding network.

[0059] In the case of the bone data SkelData, a modelling as a triangular network is also possible according to the invention. Preferably, however, joints and joint connections are modeled, for example, by means of vectors and included in a suitable data structure. Furthermore, for each joint, the usual degrees of freedom with regard to rotational and/or translational movements are stored.

[0060] The surface network MeshData and the bone data SkelData can be optimized and validated in a subsequent data validation and optimization step 220. In one exemplary embodiment, a displaying of the data takes place in step 220, wherein corrections are undertaken automatically or computer-assisted. On the basis of the corrections made, a corrected surface network MeshData results. The correction can comprise an alignment of the bone data SkelData according to a pre-defined, possibly standardized alignment, wherein the corrected surface network MeshData is deformed according to the alignment of the bone data SkelData.

[0061] The corrected surface network MeshData and the bone data SkelData are processed in a patient parameter extraction step 240. Preferably, in this step 240, with the aid of the database 25, a patient model is obtained. On the basis of this patient model, patient parameters P1, P2 are derived. These patient parameters P1, P2 can be used in the step of orthosis model creation 260 in order to generate a model of the orthosis. Preferably, some device parameters V1, V2 which provide parameters of the orthosis are already available. The orthosis model and possibly also the patient model can be visualized in a visualization step 220.

[0062] In one exemplary embodiment, the visualization can be used to adapt some of the parameters, for example, the device parameter V1 and the patient parameter P2. A corresponding adaptation can be carried out by the certified prosthetist/orthotist or, where relevant, by the patient. The adaptation can be performed in one step or in separate steps. After a change of the parameters, in a new orthosis model creation 260, an updated model of the orthosis can be created, for example, using the modified device parameter V1 and the modified patient parameter P2. This results in orthosis model data OrthData, which, if met with the approval of the user after a renewed visualization 280, is passed to the production server 50 in order to initiate an orthosis production 290.

[0063] In one exemplary embodiment, the data validation and optimization step 220 comprises an alignment correction, for example, according to a particular standardized specification.

[0064] In order to correct the position of a scan, the surface network MeshData and the bone data SkelData are needed. Bone data SkelData can be, as described, a simplified bone framework which lies in the interior of the acquired object and thus within the surface network MeshData. In one exemplary embodiment, data which models the interaction between the bone data SkelData and the surface network MeshData is available.

[0065] For example, vectors can specify distances or support sites within the surface network. Corresponding vectors can be obtained based upon templates that are stored in the database 25.

[0066] A movement of the bones for the alignment correction leads to a deformation of the modeled 3D object and thus to an amended surface network.

[0067] According to the invention, the anatomical conditions can be taken into account. In one exemplary embodiment, making use of the template, the bone data SkelData is adapted to the surface network obtained and is improved by means of further process steps in order to be able to model the most realistic possible deformation. The resulting corrected surface network MeshData can be used for the extraction of patient parameters.

[0068] For example, in the production of a patient-customized ankle-foot orthosis (AFO), a lower leg scan can be examined. According to the invention, in step 220, the scan or the associated raw data ScanData can be brought into a corrected position. For this purpose, in a first step, the orientation of the foot is identified and brought into a defined orientation.

[0069] In order to be able to assess the position during the scan, angles of the bone modelbone data SkelDataare investigated together with further biometric axes and planes. If these angles deviate from a selected measurement, the bone data SkelData is adapted/aligned, so that the scan is also changed (corrected surface network MeshData).

[0070] According to the invention, the following steps are carried out, for example: [0071] creating a patient model based upon the bone data SkelData and the surface data MeshData; [0072] finding the foot in the patient model; [0073] using the existing data in order to determine a support plane; [0074] modifying a model based upon the bone data SkelData until the support plane is oriented parallel to a virtual base surface, for example, rotation about the ankle (first alignment correction); [0075] modifying the model until the angle of a knee joint takes a pre-determined value (second alignment correction); [0076] modifying the surface data MeshData on the basis of the first and second alignment correction to obtain the corrected surface data MeshData.

[0077] The alignment correction described can enable an extraction of patient data or can significantly improve the result.

[0078] In one exemplary embodiment, the patient parameter extraction step 240 follows the scheme below.

[0079] For the construction of a patient-customized ankle-foot orthosis (AFO), for example, different length and circumference measurements of the foot and lower leg (patient parameters) are needed. In order to extract these from the raw data ScanData, it is possible to proceed as follows:

[0080] The surface data MeshData of the patient is aligned and brought into a reference system from which it can be concluded which part of the scan represents the foot and which part the leg. A simplified foot model is then placed in the surface data MeshData.

[0081] This foot model, which is possibly stored in the database 25, is known and can be amended on the basis of its degrees of freedome.g. length, scaling, rotation of subcomponents, etc.

[0082] In an optimization process, the degrees of freedom of the foot model are adapted to surface data MeshData until the correlation of MeshData and the foot model is optimized (with the smallest possible deviation). In an exemplary embodiment, the process continues accordingly with the Significant Points Model (SPM), which is used for the extraction of the measurements.

[0083] The SPM consists of points and planes between which measurements are extracted. The measurement extraction points from the SPM are projected onto the surface data MeshData or the corrected surface data MeshData. This takes place differently according to the measurement type. Circumference measurements require a sectional plane but length measurements need only points.

[0084] The dimensions are extracted between these projected points or along the sectional planes. They can be entered, for example, into a measurement sheet. In one exemplary embodiment, the visualization step 220 comprises the creation of a 3D image of the orthosis. In another exemplary embodiment, for the visualization of patient data, a measurement sheet which is similar or identical to that shown in FIG. 5 is displayed and/or printed out.

[0085] A production method and a system for producing an orthosis have been described above. Using the essential features of the invention, a prosthesis, for example a foot prosthesis as shown in FIG. 4, can also be produced without difficulty.

[0086] The production of endoprostheses or preventive orthoses (protectors for rehabilitation and sport) with the same method is also conceivable.

REFERENCE SIGNS

[0087] 1 Internet [0088] 10 CPO computer [0089] 12 Scanner [0090] 20 Design server [0091] 23 Design server interface [0092] 24 Computer unit [0093] 25 Database [0094] 40 Web server [0095] 50 Production server [0096] 52 3D printing [0097] 100 Patient computer [0098] 210 Pre-processing (e.g. bone data extraction) [0099] 220 Data validation and optimization [0100] 240 Patient parameter extraction [0101] 260 Orthosis model creation [0102] 280 Visualization [0103] 290 Orthosis production [0104] ScanData Raw data [0105] MeshData Surface network [0106] MeshData Corrected surface network [0107] OrthData 3D orthosis model data [0108] SkelData Bone data [0109] P1, P2, P2 Patient parameters [0110] V1, V2, V1 Orthosis parameters