Shoe insole, in particular a customized and / or orthopaedic shoe insole

Abstract

Shoe insole (10), in particular individualized and / or orthopaedic shoe insole, which is manufactured from at least a first and a second material (2-8) in an additive manufacturing process, wherein at least one area, in particular an individualized area, of the shoe insole (10) comprises the first material and the second material (2-8), wherein the first and the second material have at least one different property, wherein the at least one area, in particular the at least one individualized area, has sharp transitions (SE) between the first and the second material (2-8), wherein the sharp transitions (SE) are produced by adding the first and second material (2-8) in a single-material manner during the additive manufacturing process.

Description

Technical field

[0001] The application concerns a shoe insole, in particular an individualized and / or orthopaedic shoe insole, a manufacturing device and an operating device. background

[0002] German patent DE102013224142A1 describes an insole with a shape adapted to the user's foot, which contains or is made of at least one polymer material. Furthermore, a method for manufacturing an insole is described, comprising the following steps: determining the user's foot shape, determining and digitizing the shape of the insole, calculating production data, and outputting the production data to an additive manufacturing process.

[0003] German patent DE102016124724A1 describes an individualized orthopedic shoe insole with a base component manufactured using an additive manufacturing process. The base component comprises a support section, a cushioning section, and a receiving section. An insert can be placed into the receiving section for individualized therapy.

[0004] The purpose of the application is to create an improved shoe insole and an improved manufacturing process for an individualized orthopaedic shoe insole.

[0005] This problem is solved by a shoe insole, in particular an individualized and / or orthopedic shoe insole, with the features of claim 1, by a method with the features of claim 9, and by a computer program product with the features of claim 17. Embodiments are specified in the dependent claims. Overview

[0006] A shoe insole is manufactured from at least one primary and one secondary material using an additive manufacturing process. The shoe insole can be, for example, a customized shoe insole, an orthopedic shoe insole, or a customized orthopedic shoe insole. At least one area, particularly a customized area, of the shoe insole contains both the primary and secondary materials. The primary and secondary materials each possess at least one different property.

[0007] The shoe insole may contain additional materials. Areas of the shoe insole containing these additional materials may also be manufactured using additive manufacturing processes.

[0008] An orthotic insole serves medical purposes in the treatment of deformities and / or diseases of the musculoskeletal system. A customized insole is individually manufactured for a user, specifically tailored to the user's unique foot shape and functional requirements. The shape of the insole, in combination with the chosen materials, is customized, meaning it is specifically designed for an individual, particularly the future user of the insole. This customization is primarily achieved through individualized areas within the insole. A customized orthotic insole is manufactured specifically for the user, taking into account their foot shape and in accordance with the medical findings and treatment objectives.Individualization relates to the individual orthopedic medical treatment purpose, the individual foot shape, as well as further possible individual adjustments, e.g., regarding color.

[0009] A generative manufacturing process is an automated process for producing three-dimensional physical objects from a production data set, such as a 3D CAD data set. It is based on the layer-by-layer principle and can be performed without component-specific tooling. The technical implementation is based on layers and is therefore also referred to as layer-based technology or layer-oriented technology. Generative manufacturing processes include, for example, additive manufacturing processes and / or processes that utilize layer-based technologies. 3D printing, such as FDM (Fused Deposition Modeling), can be used as an example of a generative manufacturing process.As an additive manufacturing process, injection molding can also be used, in which layers are added additively by injection molding. The injection mold is also independent of the component and can be determined from the production data set during manufacturing and provided by the manufacturing device using this data set. Molding processes can be used in this case, for example, where molds are filled with foam, e.g., by foaming.

[0010] The first and second materials exhibit at least one different property. The other materials also exhibit different properties from each other and from the first and second materials. The different property(ies) of the first and second materials and the different properties of the other materials can be achieved through the additive manufacturing process and / or through at least one property of a starting material used in the additive manufacturing process. The properties of the different materials can therefore be achieved through the use of the starting material for the additive manufacturing process, e.g., by choosing a different plastic or other material as the starting material, and / or through the additive manufacturing process itself.In additive manufacturing, various properties can be achieved, particularly through the creation of cavities or similar features. A starting material is processed by the manufacturing process to build the insert. During this build-up process, the starting material's properties can change; for example, the density and / or strength can be altered by creating cavities. These cavities can form either an open or closed cell structure.

[0011] In various embodiments of the shoe insole, the properties of the first and second materials differ with regard to appearance, strength, stiffness, hardness, density, and / or electrical conductivity. Strength describes the load-bearing capacity against mechanical stresses, i.e., the property that describes how strongly something holds or breaks under the influence of forces. Stiffness describes the resistance to deformation under mechanical stresses. Hardness describes a material's resistance to local penetration.

[0012] In terms of appearance, different materials can vary, particularly in color. Furthermore, the materials may also exhibit ESD (electrostatic discharge) properties, which is especially important for insoles used in occupational safety.

[0013] At least one area, particularly the customized area, can exhibit sharp transitions between the first and second materials. These sharp transitions are created by adding the first and second materials separately during the additive manufacturing process. In this single-material addition, the first and second materials are added, i.e., applied, separately from each other. Mixing of the materials only occurs during the application process itself, when newly applied single-material material comes into contact with a previously applied material.

[0014] In embodiments of the shoe insole, the transitions between the first and second materials can be open-cell. Open-cell and closed-cell, in particular, characterize plastics that have a cellular structure with cellular cavities. Closed-cell characterizes a structure with closed cells, i.e., a structure where the walls between the individual cells are completely closed. The structure is open-cell when the cell walls are not closed. Therefore, in the transition areas, the first and second materials can exhibit open-cell structures. In the described shoe insole, sharp transitions between different materials can be achieved through additive manufacturing processes using at least the first and second materials, even with open-cell structures.The sharply defined transitions can be designed so that they are imperceptible, which can improve comfort and the therapeutic effect. At the same time, this ensures that the insole stays firmly in place at the transitions and does not fall apart.

[0015] The shoe insole can be designed in such a way that the first and second materials cannot be separated from each other without destruction. This means that the two materials can only be separated by destroying the shoe insole.

[0016] In one embodiment of the shoe insole, at least one individualized area features characters made of the first material, which are embedded in the second material. These characters allow for inscriptions on the insole, such as names, barcodes, or information required for medical devices. The properties of the materials involved, particularly their color, can be selected to ensure good legibility, especially in terms of contrast. The sharp transitions between the materials contribute to the legibility of the characters.

[0017] At least one individualized area can be designed for individualized therapy through the shape and arrangement of the first and second materials. This individualized area is specifically designed for medical therapy, which can be carried out using shoe inserts, also called insoles, orthotics, or foot orthotics. The clearly defined transitions allow for precisely defined properties, particularly a precisely defined hardness, to be achieved at the interfaces of the areas intended for therapy.

[0018] The individualized area for individual therapy can differ from the previously described individualized area with written symbols. The shoe insole can feature this individualized area for individual therapy in addition to, or as an alternative to, the individualized area with written symbols. The clearly defined transitions allow for, for example, good legibility of the written symbols and / or precisely defined properties, particularly a precisely defined hardness, at the transitions of the areas designated for therapy.

[0019] In various embodiments, the shoe insole can have three or more different materials. For example, the shoe insole can have a first area, which can be customized, with lettering, and which consists of two materials. Additionally, the shoe insole can have a second area, which can also be customized, with two materials for therapeutic purposes.

[0020] For therapeutic purposes, the shoe insole can be equipped with stiffening elements, which are manufactured, for example, using additive manufacturing processes. Stiffening elements can also be added in separate manufacturing steps. Furthermore, it is possible to equip the shoe insole with additional inserts, such as for pressure measurement and / or other sensors like pedometers. These inserts can also include, for example, RFID chips and / or other technical and / or electronic components.

[0021] In a method for manufacturing a shoe insole, in particular an individualized and / or orthopedic shoe insole, with at least one area, in particular an individualized area, comprising at least one first and one second material, the shoe insole is manufactured from the first and the second material using an additive manufacturing process. In this process, both the first and the second material are added to the shoe insole by the additive manufacturing process, wherein the shoe insole has areas that contain the first and the second material and are manufactured in a particularly individualized manner for the respective foot shape and according to the medical findings and the treatment purpose by the additive manufacturing process.

[0022] In one embodiment of the method, sharp transitions of at least one area, which can be customized, are produced by adding the first and second materials separately during the additive manufacturing process. During this single-material addition, the first and second materials are added, i.e., applied, separately from each other. Mixing of the materials only occurs during the application itself, when newly applied single-material material comes into contact with previously applied, different material.

[0023] It is proposed that the first material be added (i.e., applied) by a first dispensing device of a production machine, and the second material be added (i.e., applied) by a second dispensing device of the production machine. The first and second dispensing devices can be controlled by a common control unit of the production machine. Further materials can be applied by additional dispensing devices of the production machine. These additional dispensing devices can also be controlled by the control unit of the production machine.

[0024] The dispensing devices can be, for example, nozzles from which the material used for additive manufacturing is applied. By using such dispensing devices, each dedicated to a specific material, the materials used are not mixed before application. This prevents unwanted mixtures of materials with unknown properties in the insert. As a result, a high degree of repeatability in production can be achieved according to specifications.

[0025] The process may further include the following steps: A) Collection of individual data, in particular patient data, medical history, indications, shoe type, intended use B) Automatic determination of properties of at least one area, in particular an individualized area, of the shoe insole using the individual data, C) Generation of a production data set and transmission of the production data set to the manufacturing device, D) Manufacturing the shoe insole using the additive manufacturing process through the manufacturing device using the production data set.

[0026] Additionally, the individual data collected in step A can be automatically checked for plausibility and / or completeness. The production data set includes the data required by the manufacturing equipment to produce the shoe insole.

[0027] In one embodiment of the method, the properties determined in step B are displayed on an operating device, and changes to these properties can be received via the operating device. Optionally, the changes received via the operating device can be automatically checked for plausibility and / or completeness.

[0028] This process enables the precise, repeatable production of shoe insoles with the desired therapeutic effect, depending on the indication and patient history. The ability to generate text using this method facilitates compliance with legal requirements, particularly in the medical field. Examples include the ability to place labels, markings, serial numbers, and designations such as "medical device" on the shoe insole and to verify their completeness and / or plausibility. While adhering to data protection regulations, the marking can be limited to the legally required data. Through automated plausibility checks and data verification, the accuracy of the production data set can be verified before the shoe insole is manufactured, also while maintaining data protection. In the event of a manufacturing error, the product can be remanufactured after error detection and optional correction, e.g.,...A correct insole can be manufactured by repeating one or more of steps A to D.

[0029] Various steps of the process can be carried out spatially separated from one another by different parties.

[0030] A computer program product contains instructions which, when the program is executed by one or more data processing devices, in particular the control unit and / or the operating device, cause one or more data processing devices to execute the steps of the method for manufacturing a shoe insole, in particular a customized and / or orthopaedic shoe insole. List of characters

[0031] Examples of implementation are shown in the drawing and are explained in more detail in the following description.

[0032] They show Fig. 1 a schematic representation of a top view from below of a first embodiment of a shoe insole, Fig. 2 a schematic representation of a top view from below of a second embodiment of the shoe insole, Fig. 3 a schematic representation of a top view from below of a third embodiment of the shoe insole, Fig. 4 a schematic representation of a structure and a top view of the first embodiment of the shoe insole, Fig. 5 a schematic representation of a structure and a top view of the sagittal plane of the first embodiment of the shoe insole, Fig. 6 a schematic representation of the structure and a top view of the sagittal plane of the second embodiment of the shoe insole, Fig. 7 a schematic representation of a structure and a top view of the frontal plane of the first embodiment of the shoe insole, Fig. 8 a schematic representation of a structure and a top view of the frontal plane of the second embodiment of the shoe insole, Fig. 9 a schematic representation of a method for manufacturing such a shoe insole and Fig. 10 a schematic representation of a user interface of an operating device.

[0033] The same reference symbols are used in the figures for identical or similar elements. The representation in the figures does not need to be to scale. Character description

[0034] Fig. Figure 1 shows a schematic representation of the structure of a first embodiment of an individualized orthopedic shoe insole 10. The shoe insole 10 comprises various materials 2, 3, 6, 8. These different materials 2, 3, 6, 8 have different properties, which can be achieved, for example, through different starting materials in the production process and / or through the production process itself, e.g., through shaping. A text field 1 is provided, which can display characters made of a material 8. The area of ​​the text field 1 can be individualized, in particular, by means of characters made of material 8. The shoe insole 10 can have an individual identifier through these characters. The shape of the text field 1 is freely selectable. The area containing the text field 1 can be individualized by a specific choice of characters. Fig. In the example shown, material 8 borders either material 2 and / or material 3, depending on the choice of the position of the characters. Material 8 is preferably chosen so that the contrast to the adjacent materials 2 and 3 is high enough to ensure that the characters are legible.

[0035] In exemplary embodiments, the title block can also be made of a separate material, which differs from the other materials 2-8, particularly with regard to color. In such exemplary embodiments, the characters made of material 8 would then border the title block's own material, forming sharply defined transitions UE. Such a design of the title block is possible for all exemplary embodiments in all figures.

[0036] Material 3, for example, is a loosely structured material used to define the hardness of the shoe insole 10 and to adjust its weight. This loose structure can be achieved, for instance, during the manufacturing process of the insole 10 by incorporating cavities, or multiple cavities, and / or larger cavities. These cavities can be structured as either open-cell or closed-cell structures. During manufacturing, particularly through additive manufacturing, the cells can be created, for example, by constructing walls around the cavities, i.e., gas-filled areas. The size of the cells also influences the structure. Larger cavities enclosed by cells, for example, can result in a looser structure.

[0037] Material 2 is a compact, dense material used to reinforce the shoe insole 10, for example, in the outer area of ​​the insole 10. The compact structure can be achieved, for example, during the manufacturing of the insole 10 by incorporating few or no cavities. The transitions UE from material 2 to other materials can therefore be closed and have walls. The in Fig. The illustrated embodiment 1 features an inlay made of material 6. Material 6 has, for example, a different hardness than material 3 and / or material 2. By appropriately selecting, for example, the hardness of material 6, a therapeutic effect can be achieved through the inlay.

[0038] An inlay is a section incorporated into the shoe insole, in any shape, such as round, oval, elliptical, square, or triangular. The material of the inlay can, for example, have cavities and thus a loose structure. Such an inlay can achieve, for example, medical-orthopedic effects. The inlay can also be made of a hard material. In particular, the hardness of the inlay can be individually tailored to the user. The hardness of the inlay can also be adapted to orthopedic needs.

[0039] The shoe insole 10 can exhibit sharply defined transitions UE between the respective different materials 2, 3, 6, and 8. A sharply defined transition UE, as used here, means that two different materials are applied to the insole 10 during its manufacture without prior mixing. When one material is applied to another during the addition process, the two materials can merge at the edges, i.e., in the transition area between the two materials. These areas are so small compared to the insole 10 that they are described as sharply defined. This has the advantage that mixing of the materials remains minimal at the transitions UE, so that well-defined, known material properties can be assigned to individual areas of the insole 10. There is no mixing of materials to which no defined property can then be assigned.This is particularly important for medical devices, for example. Furthermore, it is possible to implement the design in such a way that no boundaries or separations are perceptible at the transitions between the sub-units. This can be observed, for example, when pressing on the transition with a finger.

[0040] It is also possible to integrate various elements into the orthopedic and / or customized insole / shoe insert. These can include sensors, actuators, heating elements, batteries, electronic circuit boards, and similar components. Designated spaces can be provided for later installation, or these components can be directly and permanently integrated into the insole. This can also be achieved by selecting and positioning them within the production data set.

[0041] The insole 10 can have different areas, which can be customized. Customized areas can include, for example, cushioning elements such as inlays or stiffening elements such as a rigid spring. These are manufactured using additive manufacturing, for example, from different and distinct base materials. Through this manufacturing process, properties can be further influenced in the same way as for the rest of the insole 10. Stiffening elements can be designed, for example, as a rigid spring, detorsion stiffener, sole stiffener, and / or rearfoot stiffener, or similar. A rigid spring is a stiffening element used for the therapeutic treatment of hallux rigidus. The insole 10 is therefore an orthopedic insole 10.

[0042] Fig. Figure 2 shows a second embodiment of the individualized orthopedic shoe insole 10. The insole 10 is made of Fig. 2 features a stiffening element, e.g., a rigid spring, made of material 4. Material 4 is a firmer material with few or no cavities. The transitions UE from material 4 to other materials can therefore be closed and have walls. The insert 10 can be customized and / or adapted to orthopedic needs through the area made of material 4.

[0043] The in Fig. The shoe insole shown in Figure 2 (10) therefore has different materials (2, 3, 4, 8). The transitions (UE) of material 4 to the other materials (3, 2) are also clearly defined.

[0044] The insole 10 features a writing field 1, which can display characters made of material 8 for an individual identifier of the shoe insole 10. This allows the insole 10 to be personalized. The shape of the writing field 1 is freely selectable. Fig. In the example shown, material 8 borders – depending on the choice of the position of the characters – either material 2, material 3, and / or material 4. Material 8 is preferably chosen such that the contrast to the adjacent materials 2, 3, and 4 is high enough to ensure that the characters are legible.

[0045] Fig. Figure 3 shows a top view from below of an embodiment of the shoe insole 10. The underside of the insole 10 has a shape that depends on the shoe in which the insole 10 is to be used. At the bottom, i.e., on the side facing away from the user's foot when the shoe insole 10 is worn in a shoe, the insole 10 has a lower cover layer made of a material 7. The lower cover layer is in the Fig. The lower cover layer is closed in the embodiment shown in section 3. The lower cover layer can also be open. An open lower cover layer leaves areas exposed, so that, for example, material 2 or 3 can be seen from below in the open areas. Fig. In section 3, the writing area 1 is visible. Characters in this area are visible as Material 8 within Material 7. The transition area UE is so sharply defined that the characters are easily legible. At the same time, Materials 7 and 8 are connected in such a way that the writing cannot be removed and / or altered without destroying the insert 10.

[0046] The examples of implementation shown in Fig. 1 and Fig. The two shown do not have a lower top layer. Optionally, the ones shown in Fig. 1 and Fig. The two embodiments shown have an open or closed lower cover layer.

[0047] Fig. Figure 4 shows a schematic top view of a structure in the interior area I of the shoe insole 10 and a top view of an exterior area O of the first embodiment of the shoe insole 10. At the top, i.e., on the side facing the user's foot when the shoe insole 10 is worn in a shoe, the insole 10 has an upper cover layer made of a material 5. The upper cover layer is in the Fig. In the embodiment shown in Figure 4, the upper cover layer is closed. The upper cover layer can also be open. An open upper cover layer leaves areas exposed, so that, for example, material 2 or 3 is visible from above in these open areas. The upper cover layer made of material 5 can be manufactured using additive manufacturing. Optionally, a covering can be applied to the upper cover layer (not shown). The covering can be made of, for example, textile, microfiber, or leather. In the case of an open upper cover layer, the covering is then in contact with materials other than material 5, such as material 2 or 3, in the open areas.

[0048] In the embodiment of Fig. In section 4, material 3 is shown in a loose, lightweight version, as well as the inlay made of material 6. At the edges, the inlay 10 has a compact, dense material 2 for reinforcement. The inlay 10 has sharply defined transitions UE, e.g., between materials 2, 3, 5, and 6.

[0049] In all illustrated embodiments, the upper and lower cover layers are optional.

[0050] Fig. Figure 5 shows a schematic representation of the structure in the sagittal plane of the shoe insole 10 in the inner region I, as well as a top view of the sagittal plane of the shoe insole 10 in the outer region O. The shoe insole 10 has an inlay made of material 6 in the area where it meets material 3. Materials 3 and 6 have a sharply defined transition UE. In the outer region O, the reinforcement made of material 2 and the upper cover layer made of material 5 are shown on the top surface.

[0051] In anatomy, the sagittal plane is a plane that extends from top to bottom and from back to front. The sagittal plane divides a body into a right and a left part.

[0052] In Fig. Figure 6 shows the structure of the insert 10 in the inner region I in the sagittal plane. The outer region O shows a top view of the sagittal plane of the insert 10. The second embodiment of the insert 10 shown has a stiffening element, e.g., a rigid spring, made of material 4. The stiffening element made of material 4 has sharply defined transitions UE to material 3 and to material 2.

[0053] Fig. Figure 7 shows a schematic representation of the structure of the first embodiment of the insole 10 in the inner area I in a top view of the frontal plane of the shoe insole 10, as well as a top view of the frontal plane in the outer area O of the shoe insole 10. In this representation, the inscription field 1 and the inlay made of material 6 are shown. The area made of material 3 and the reinforcement made of material 2 are also shown. The shoe insole 10 has an upper cover layer made of material 5.

[0054] Fig. Figure 8 shows a schematic representation of the structure in the inner area I in a view of the frontal plane of the shoe insole 10, as well as a top view of the frontal plane of the shoe insole 10 in the outer area O. In the second embodiment shown, a stiffening element, e.g., a rigid spring, is provided, made of material 4. Also shown are the labeling area 1 and the area made of material 3. Reinforcements made of material 2 are provided in the outer areas O. The insole 10 also has the upper cover layer made of material 5. The transitions UE between the different materials are also shown.

[0055] Fig. Figure 9 shows a schematic representation of a method for manufacturing such a shoe insole.

[0056] In step A, the individual data is recorded. This recording is done, for example, via an operating device 100 using a user interface, such as the example shown in Fig. Figure 10 illustrates this. Data collection can be carried out, for example, by a user such as doctors, physiotherapists, healthcare professionals, orthopaedic shoemakers and / or shoe technicians.

[0057] In step A1, the foot shape is captured. This can be done, for example, using a 3D scanner, a 2D scanner, foam impression material, or a photograph.

[0058] In step A2, user data, such as patient data, is recorded. This can be done, for example, via the user interface of a control unit 100. Information such as the patient's medical history and / or indications, shoe type, and intended use can be recorded. A warning is also issued if required data is missing. Optionally, the materials for the shoe insole 10 can be selected in this step. The material selection for the lettering can be restricted to high-contrast options that ensure high visibility.

[0059] In step B, properties of at least one individualized area of ​​the shoe insole 10 are automatically determined using the individual data.

[0060] The selection of materials can, for example, be automated in step B based on data already collected in step A. The automated selection can also be displayed via the control unit 100 and optionally modified by the operator. These modifications can also be automatically checked for validity and / or plausibility.

[0061] In step B, a design proposal for the orthotic insole is generated based on the patient's medical history. This can be done in real time, for example. This proposal can then be displayed to the operator via control unit 100. The operator can review the proposal and modify it if necessary. These modifications can also be automatically checked for feasibility and / or plausibility.

[0062] In step C, the production data set is automatically generated and transmitted to the manufacturing device.

[0063] Steps B and C can also be performed together in one step.

[0064] In step D, the insert 10 is manufactured using the production data set by the manufacturing device.

[0065] Step E involves final tasks, such as optionally covering the insole 10 with the cover and delivery to the user for whom the insole 10 was individually manufactured.

[0066] The individual steps are location-independent and can even be performed in separate locations. In particular, at least parts of the process can also be executed in the cloud. Data is then linked using suitable methods, such as cryptographic methods.

[0067] This process allows for the traceability of all manufacturing steps of the shoe insole 10, which is particularly important for medical devices. A shoe insole 10 manufactured using this process is reproducible even if the production data record is lost. The production data record can be regenerated from the user's individualized data.

[0068] It is also possible for different actors to carry out steps in the process. Besides spatial separation, this allows for the decentralization of steps and thus location-independent care for the user, e.g., patients. This can be important, for example, when traveling.

[0069] Fig. Figure 10 shows a schematic representation of the user interface of the operating device 100. The operator can then use this user interface to enter individualized data that is to be recorded for the therapy of the user, e.g., patients.

[0070] Field 101 can be used to enter, for example, an order number or MD SN number, or—if automatically generated by the process—to display it for the operator's information. The user's shoe size for insole 10 can be entered in field 102. Field 103 allows the entry of user data such as name and / or date of birth. This data can also be used to link to previous orders / productions by the same user. Field 116 can be configured as a date field, in which, for example, the date of data entry and / or the planned completion and / or delivery date can be entered.

[0071] Fields 104 and 105 allow you to select colors for materials 2 through 8 and any additional materials. An automatic check ensures sufficient contrast, particularly for the color selection of characters from material 8. This color selection can also be used to achieve a distinctive color scheme, for example, according to company guidelines.

[0072] Area 107 displays the automatically generated proposal for the design of the insole 10, featuring individualized therapy zones based on the individualized data on complaints / indications collected via the anamnesis 111, 112. The placement of the various zones, e.g., hardening areas, inlays, and stiffening, is visualized in field 107. Area 107 can be edited via control panel 106 to make manual modifications to supplement the automatically generated proposal.

[0073] Field 108 allows you to manually enter text related to the patient's medical history. Field 109 allows you to manually enter text regarding the design of the insole 10. Field 110 displays an automatically generated recommendation text, e.g., for further therapeutic measures, which can be manually edited. Further therapeutic measures may include, for example, shoe-related adjustments, recommendations to consult a physiotherapist and / or physician, etc.

[0074] Using the anamnesis tool 112, complaints and / or indications, which may have been determined through a conversation with the user, can be selected via a point selection. These points allow for the targeted selection of painful areas and misalignments, i.e., indications. The control panel 111 allows for the selection of the intensity and / or severity of the complaints and / or indications for the left and right sides. Different values ​​can be set for the left and right sides.

[0075] Based on the selected complaints in the anamnesis tool 112, suggestions for the design of the insole 10 are generated and displayed in area 107. A warning can be issued after manual modification. This prevents accidental changes.

[0076] Field 113 allows you to enter the reference for insole 10. Field 114 allows you to specify or select the type of insole 10. The type of insole can be, for example, a cushioning insole, a supportive insole, a corrective insole, and / or a shell insole. Field 115 allows you to specify the shoe style. Shoe styles can be, for example, athletic shoes, casual shoes, dress shoes, health shoes, or orthopedic shoes.

[0077] Using the individualized data captured via the user interface in step A2, the design of the insole for therapy is determined in step B. This is displayed in area 107 of the user interface to allow the user to make changes. Then, in conjunction with the data from the digital image of the foot captured in step A1, the design of insole 10 for therapy, including the individualized areas, is adapted to the user's foot. The correct placement of the individualized areas to be manufactured with a different material also takes place here. In this step, insole 10 thus assumes its final shape using the data from steps A1 and A2. Similarly, the placement of the labeling using materials 1 and 8 occurs in step B. The labeling is generally freely selectable, but must comply with legal regulations, especially for a medical device.

[0078] In step C, the production data set is then generated. This is used by the manufacturing device to produce the orthopedic shoe insole 10. Data, such as machine code and / or a CAD model, which the machine needs for production, is generated and sent to the manufacturing machine.

[0079] The process also includes control mechanisms to verify the transfer of the production data set to the manufacturing machine. For example, the data can be checked to ensure it contains the minimum required information or is complete. After the insole 10 has been manufactured, a further control loop verifies its success. In the event of a manufacturing defect, for example, the orthopedic shoe insole 10 can be manufactured again.

[0080] Throughout the entire process, the user, e.g., an orthopaedic shoemaker / technician, can see, for example, via an additional user interface on the operating device, which stage of the production process is currently in. The production process is thus traceable. This also allows for documentation that is legally required for medical devices, such as specifying which batch of which material was used to manufacture orthopaedic shoe insole 10. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 102013224142A1

[0002] DE 102016124724A1

[0003]

Claims

[1] Shoe insole (10), in particular individualized and / or orthopaedic shoe insole, which is manufactured from at least a first and a second material (2-8) in an additive manufacturing process, wherein at least one area, in particular an individualized area, of the shoe insole (10) comprises the first material and the second material (2-8), wherein the first and the second material have at least one different property, wherein the at least one area, in particular the at least one individualized area, has sharp transitions (SE) between the first and the second material (2-8), wherein the sharp transitions (SE) are produced by adding the first and second material (2-8) in a single-material manner during the additive manufacturing process. [2] Shoe insole according to claim 1, wherein the at least one different property of the first and the second material (2-8) is achieved by the additive manufacturing process and / or by at least one property of a starting material used by the additive manufacturing process. [3] Shoe insole according to claim 2, wherein at least one property of the first and the second material (2-8) differs from each other with regard to colour, strength, stiffness, hardness, density and / or electrical conductivity. [4] Shoe insole according to one of the preceding claims, wherein the at least one area, in particular the at least one individualized area, has transitions (UE) between the first and the second material (2-8) which are open-cell. [5] Shoe insole according to one of the preceding claims, wherein the first and the second material (2-8) can only be separated from each other by destroying the shoe insole (10). [6] Shoe insole according to one of the preceding claims, wherein the at least one individualized area has at least one character made of the first material (8) which is embedded in the second material (2-7). [7] Shoe insole according to one of the preceding claims, wherein the at least one individualized area is formed by a shape and arrangement of first and second material (2-8) for individual therapy. [8] Manufacturing device for producing a shoe insole (10), in particular an individualized and / or orthopaedic shoe insole, wherein the manufacturing device is configured to produce the shoe insole (10) from at least a first and a second material (2-8) by means of an additive manufacturing process, wherein the shoe insole (10) has at least one area, in particular an individualized area, with the first material and the second material (2-8), and wherein the manufacturing device is configured to produce sharp transitions (UE) between the first and the second material (2-8) by adding the first and second material (2-8) in a single-material manner during the additive manufacturing process. [9] Manufacturing device according to claim 8, wherein the manufacturing device is configured to add the first material (2-8) through a first dispensing device of the manufacturing device and to add the second material (2-8) through a second dispensing device of the manufacturing device, wherein the dispensing devices are in particular controllable by a common control unit of the manufacturing device. [10] Manufacturing device according to claim 9, wherein each further material can be added by a further dispensing device of the manufacturing device, wherein the dispensing devices can in particular be controlled by a common control unit of the manufacturing device. [11] Manufacturing apparatus according to claim 8, 9 or 10, wherein the manufacturing apparatus is further configured as follows: to receive a production data set to produce the shoe insole (10) using the generative process with the production data set, wherein the production data set includes the data required by the manufacturing device to produce the shoe insole (10) and wherein properties of at least one individualized area of ​​the shoe insole (10) were automatically determined using individual data. [12] Operating device (100), which is set up, to collect individual data to automatically determine the properties of at least one individualized area of ​​a shoe insole (10) using the individual data, to generate a production data set and transmit it to a manufacturing device, wherein the manufacturing device is configured to produce the shoe insole from at least one first and one second material (2-8) by means of an additive manufacturing process, wherein the shoe insole (10) has the at least one individualized area with the first material and the second material (2-8), and wherein the manufacturing device is configured to produce sharp transitions (UE) between the first and the second material by adding the first and second material (2-8) in a single-material manner during the additive manufacturing process, wherein the production data set includes the data required by the manufacturing device to produce the shoe insole (10) and wherein properties of at least one individualized area of ​​the shoe insole (10) were automatically determined using the individual data. [13] Operating device (100) according to claim 12, wherein the operating device is further configured to check the recorded individual data for plausibility and / or completeness. [14] Control device (100) according to claim 12 or 13, wherein the determined properties can be displayed on the control device (100) and changes in the properties can be received via the control device (100). [15] Operating device (100) according to claim 14, wherein the operating device is further configured to automatically check the received changes for plausibility and / or completeness.

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