JPWO2020070952A1 - Orthosis, orthosis manufacturing equipment, orthosis surface treatment equipment, and orthosis manufacturing system - Google Patents

Abstract

It is an orthosis worn on the human body and has a surface roughness of 15 μm to 300 μm. Such roughness is the arithmetic mean roughness (Ra). In the orthosis, the value of the surface roughness of the part that comes into contact with the human body is smaller than the value of the surface roughness of the part that does not come into contact with the human body. The orthosis is an ankle foot orthosis using resin, and the part that comes into contact with the human body is the inner surface of the ankle foot orthosis.

Description

The present invention relates to an orthosis, an orthosis manufacturing apparatus, an orthosis surface treatment apparatus, and an orthosis manufacturing system.

There is known an "orthosis" that is attached to a part of the human body to correct, support or fix the part of the human body. Orthoses are mainly used to compensate for the reduced function and to protect and support the affected area by limiting the movement of the joints of the human body when the function of a part of the human body deteriorates due to illness or injury. It is attached to.

This type of orthosis is generally manufactured according to the shape of a part of the human body to be worn (for example, a foot, an elbow, a wrist, a leg, and a knee) (hereinafter, referred to as a “brace wearing part”). On the other hand, unlike a cast made of plaster or the like, this type of orthosis is required to allow the orthosis attachment part to move freely to some extent while limiting the movement of the joints of the human body, so that the shape and expansion and contraction are required. In terms of sex, etc., a high degree of compatibility with the patient's orthosis attachment site is required. In addition, since this type of orthosis is worn on a daily basis, comfort and strength are also required.

On the other hand, since the patient's orthosis wearing site and the patient's physical disability mode (for example, fracture mode) are different for each patient, the completed form of each orthosis varies greatly from individual to individual.

Conventionally, prosthetists have been manufactured by doctors and specialists (hereinafter referred to as "prosthetists") to suit each patient. As an example of a specific manufacturing method of a conventional ankle foot orthosis (AFO: Ankle Foot Orthosis, also called "sole orthosis"), a hand as described in the following steps (1) to (7). It is a process of work.
(1) Wrap a protective film around the patient's foot.
(2) Mark the palpation result on the protective film.
(3) Create a foot-shaped negative model using a cast.
(4) A positive model of the foot type is created by pouring plaster into the negative model of the foot type and hardening it.
(5) Processing is performed based on the marking transferred to gypsum.
(6) A thermoplastic resin film (or sheet) is pressed against a positive model of the foot shape, and the film is cured to form an orthosis suitable for the foot shape.
(7) The orthosis orthosis performs post-processing (for example, shape adjustment using a heat gun as shown in FIG. 1) according to the patient on the orthosis formed above, and prepares the final orthosis.

On the other hand, with the recent increase in accuracy of measuring devices and three-dimensional modeling devices, a method of three-dimensionally modeling an orthosis using a three-dimensional modeling device such as a 3D printer has also been studied (see, for example, Patent Document 1).

Special Table 2013-530757

By the way, in the conventional method based on the above steps (1) to (7), there is a problem that the quality is liable to vary because it is easily influenced by the knowledge and technical differences based on the individual experience of the orthotist and the like. Further, in the conventional method, the orthosis is designed or redesigned each time according to the specific symptom of the patient and the like, and is not manufactured by using the detailed design drawing. Therefore, for example, even if the orthosis is damaged, or if you want to have an additional spare part of the orthosis in case of damage or loss, the same as the original orthosis is manufactured. Was difficult.

In view of such a problem, the present inventors 3D scan the shape (position information in the three-dimensional space) of the orthosis using a 3D scanner, and use the acquired digital data of the three-dimensional shape as a storage medium. Attempts were made to preserve the original shape of the brace by storing it. That is, by storing the digital data of the original three-dimensional shape of the orthosis and inputting the digital data into a three-dimensional modeling device such as a 3D printer to form the orthosis in three dimensions, a substantially same one as the original orthosis is manufactured ( It is thought that it can be reproduced). In addition, from the viewpoint of reproducing the original shape of the orthosis quickly and with high accuracy, a non-contact type 3D that measures the three-dimensional shape by irradiating the object to be measured (that is, the orthosis) with laser light during 3D scanning. It is considered preferable to perform the measurement using a scanner.

However, when an attempt is made to optically measure the three-dimensional shape of the orthosis using a non-contact type 3D scanner, the reflection state of the laser beam emitted from the scanner is not good, and the three-dimensional shape data of the orthosis cannot be obtained well. It has been found. It was also found that when the surface of the orthosis is processed so that optical measurement with a 3D scanner can be performed, the wearer of the orthosis (patient's skin, etc.) is affected depending on the degree of processing.

After conducting various experiments to improve the conventional orthosis, the present inventors support the optical measurement of the three-dimensional shape and thus the production of a duplicate, that is, the orthosis of the same shape, while ensuring the wearability of the wearer. We have come up with a new configuration of possible orthoses and devised the present invention.

An object of the present invention is to provide an orthosis, an orthosis manufacturing apparatus, an orthosis surface treatment apparatus, and an orthosis manufacturing system capable of ensuring both wearability of a wearer and measurement of a three-dimensional shape by a scanner.

The orthosis according to the present invention
An orthosis worn on the human body
The surface has a roughness of 15 μm to 300 μm.

The orthosis manufacturing apparatus according to the present invention
An orthosis manufacturing device that manufactures orthoses worn on the human body.
A three-dimensional modeling portion for three-dimensionally modeling the orthosis so that the surface has a roughness of 15 μm to 300 μm is provided.

The brace surface treatment device according to the present invention is
A device that processes the surface of equipment worn on the human body.
The orthosis is surface-treated so that the surface has a roughness of 15 μm to 300 μm.

The orthosis manufacturing system according to the present invention
A data generator for orthosis modeling that generates modeling shape data related to the shape of the orthosis attached to the human body,
Based on the modeling shape data, the orthosis modeling portion that three-dimensionally models the orthosis so that the surface has a roughness of 15 μm to 300 μm,
To be equipped.

According to the present invention, both the wearability of the wearer and the measurement of the three-dimensional shape by the scanner can be ensured.

It is a figure which shows an example of the mode of post-processing performed by a prosthetist or the like at the time of the conventional manual manufacturing of a prosthetist. It is a figure which shows an example of the whole structure of the equipment manufacturing system which concerns on one Embodiment. It is a figure which shows an example of the measuring apparatus which concerns on one Embodiment. It is a figure which shows an example of the data which the data generation part for orthosis modeling which concerns on one Embodiment refers to. It is a flowchart which shows an example of the operation of the data generation part for orthosis modeling which concerns on one Embodiment. It is a figure which shows an example of the three-dimensional modeling apparatus which concerns on one Embodiment. It is a flowchart which shows an example of the operation of the brace molding part which concerns on one Embodiment. It is a flowchart which shows an example of the operation of the brace shape measuring part which concerns on one Embodiment. It is a figure which shows an example of the data item stored in the management DB. It is a table which shows the list of the experimental results about the surface roughness of the brace.

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the present specification and the drawings, components having substantially the same functional configuration are designated by the same reference numerals, so that duplicate description will be omitted.

[Overall configuration of equipment manufacturing system]
FIG. 2 is a diagram showing an example of the overall configuration of the orthosis manufacturing system A according to the present embodiment.

The orthosis manufacturing system A according to the present embodiment includes a human body shape measuring unit 1, an orthosis modeling data generation unit 2, an orthosis modeling unit 3, an orthosis shape measuring unit 4, a management DB 5, and an orthosis surface processing unit 6. The outline (function, etc.) of each of these parts will be described below.

The human body shape measuring unit 1 measures the shape of the orthosis mounting portion of the human body using a measuring device, and generates three-dimensional shape data (hereinafter, also referred to as “human body shape data”) D1 of the human body.

The orthosis modeling data generation unit 2 generates the orthosis modeling shape data D4 based on the human body shape data D1, the orthosis model shape data D2, and the manufacturing history data D3 related to other orthoses manufactured in the past. Generate.

The orthosis modeling unit 3 is provided with a three-dimensional modeling device such as a 3D printer, which will be described later, and three-dimensionally models the orthosis based on the modeling shape data D4.

The orthosis shape measuring unit 4 irradiates the orthosis with light to measure the three-dimensional shape of the orthosis (3D scanning), and the three-dimensional shape measurement data of the orthosis based on the measurement result (hereinafter referred to as "orthosis shape measurement data"). ) D5 is generated, and the generated orthosis shape measurement data D5 is stored in the management DB5. In one specific example, a projector-type 3D scanning device using blue light or white light is used as the orthosis shape measuring unit 4. In this 3D scanning device, laser light is generated using various light sources, the generated laser light is irradiated to an object (that is, a device), the laser light reflected from the device is identified by a sensor, and the distance to the device is measured. By doing so, the orthosis shape measurement data D5 is generated.

The management DB 5 stores model shape data D2 that defines the base shape of the orthosis and manufacturing history data D3 that registers the shape and the like of the orthosis manufactured in the past. The management DB 5 acquires the orthosis shape measurement data D5 from the orthosis shape measurement unit 4, associates it with the human body shape data D1 and the modeling shape data D4 of the corresponding orthosis, and stores it as manufacturing history data D3 (see FIG. 4 described later). ).

The brace surface treatment unit 6 mainly uses the surface of a brace (hereinafter referred to as “conventional product”) manufactured by conventional manual work (see steps (1) to (7) described above) as described later. Process so that the roughness of the numerical range is obtained. Further, when the orthosis surface processing unit 6 cannot generate the orthosis shape measurement data D5 when measuring the three-dimensional shape of the orthosis by the orthosis shape measuring unit 4, the surface of the orthosis is roughened in a numerical range as described later. Process so that it becomes.

The human body shape measurement unit 1, the equipment modeling data generation unit 2, the equipment modeling unit 3, the equipment shape measurement unit 4, the management DB 5, and the equipment surface processing unit 6 are, for example, a CPU (Central Processing Unit) and a ROM, respectively. (Read Only Memory), RAM (Random Access Memory), operation input unit (keyboard, mouse, etc.), display unit (liquid crystal display, etc.), input port, output port, etc. Each function of the human body shape measuring unit 1, the orthosis modeling data generation unit 2, the orthosis modeling unit 3, the orthosis shape measuring unit 4, and the orthosis surface processing unit 6 is, for example, a control program in which the CPU is stored in a ROM, RAM, or the like. It is realized by referring to various data.

In FIG. 2, the arrow indicates a manufacturing flow when manufacturing the orthosis M. In the manufacturing flow of the orthosis manufacturing system A, a step of manually post-processing the orthosis by an orthotist or the like in parallel with the surface treatment step performed by the orthosis surface treatment unit 6 (indicated by T in FIG. 2). May be added arbitrarily.

The manufacturing flow when manufacturing the brace M is as follows: (01) when manufacturing the brace M for a new patient, (02) when manufacturing a duplicate of the brace M manufactured in the past by this system, (03) conventional When producing a duplicate of a product, it may differ from.

The manufacturing flow in the case of the above (01) is a step of measuring the shape (human body shape data D1) of the orthosis wearing portion of the patient by the human body shape measuring unit 1, and the orthosis shape data D4 of the orthosis M by the orthosis modeling data generation unit 2. The step of forming the brace M by the brace modeling unit 3, the step of acquiring the brace shape measurement data D5 of the brace M by the brace shape measuring unit 4, and so on are executed in order. Further, prior to the measurement of the three-dimensional shape of the orthosis M by the orthosis shape measuring unit 4, a step of manually post-processing the orthosis (indicated by T in FIG. 2) can be arbitrarily executed by a prosthetist or the like. ..

The manufacturing flow in the case of (02) is a step of measuring the shape of the orthosis mounting portion of the human body by the human body shape measuring unit 1 and a step of manually post-processing the orthosis by an orthotist or the like among the above steps. Can be omitted.

In the manufacturing flow in the case of (03) above, the step of roughening the surface of the brace M by the brace surface treatment unit 6 and the step of acquiring the brace shape measurement data D5 of the brace M by the brace shape measuring unit 4 are executed in order. It will be.

In each of the above cases (01) to (03), the surface treatment of the orthosis by the orthosis surface treatment unit 6 depends on the result of the three-dimensional shape measurement processing by the orthosis shape measurement unit 4, that is, the orthosis shape measurement of the orthosis M. It can be repeatedly executed until the data D5 can be acquired.

By such a manufacturing flow, one orthosis M that secures the wearability of the wearer (patient) and the optical measurableness of the three-dimensional shape is completed, and the manufacturing history data D3 related to the orthosis M is accumulated.

In the present embodiment, the brace M is integrally formed of one material (for example, a thermoplastic resin), but the structure of the brace M can be variously modified.

For example, the orthosis M may be manufactured by connecting a plurality of parts. Further, the orthosis M does not have to be formed of only one homogeneous material, and the component of the material or the like may be changed according to the portion of the orthosis M. Further, the brace M may have a pad or the like for making the raised portion of the bone flexible. Further, the orthosis M may have a hole in a predetermined area for the purpose of enhancing breathability and flexibility. On the other hand, from the viewpoint of simplifying or facilitating manual work by an orthotist or the like, surface processing by the orthosis surface treatment unit 6, and 3D scanning by the orthosis shape measurement unit 4, the configuration is as simple as possible (simple shape, etc.). It is better to say. Further, when performing 3D scanning by the device shape measuring unit 4 or surface processing by the device surface treatment unit 6, it is preferable to remove the accessory of the device M (band Mt in the example shown in FIG. 2) as appropriate. ..

More preferably, a thermoplastic resin is used as the material constituting the brace M. As the thermoplastic resin, for example, polypropylene resin, polyethylene resin, vinyl chloride resin, polycarbonate resin, ABS resin, polyamide resin (particularly nylon 6, nylon 11, nylon 12), methacrylic resin and the like are particularly useful. The thermoplastic resin is lightweight and has high strength, and also has good biocompatibility. Further, by using a thermoplastic resin, powder sintering and lamination type three-dimensional modeling is possible.

As the material constituting the brace M, a UV curable resin or a thermosetting resin may be used instead of the above-mentioned thermoplastic resin. As the UV curable resin or the thermosetting resin, for example, a polyurethane resin, an epoxy resin, a silicone resin, an acrylic resin, or the like is useful.

By the way, as described above, in the conventional method, the orthosis M is designed or redesigned each time according to the specific symptom of the patient, and is manufactured by using a detailed design drawing. There wasn't. Therefore, for example, even if the orthosis M is damaged, or if it is desired to prepare a spare part of the orthosis M in case of damage or loss, the same as the original orthosis M is manufactured. Was difficult.

In addition, generally called "plastic orthosis", orthosis using various resins as described above is widely used because it has many advantages such as light weight, stain resistance, and no noise during use. On the other hand, there are also weaknesses such as being unable to repair if damaged and having a shorter service life than equipment with metal columns. For this reason, especially in the case of the resin orthosis M, there is a potential demand for users who want to acquire spare replicas at low cost.

In general, conventional devices and systems for manufacturing the orthosis M do not have the viewpoint or idea of reproducing the same shape as the completed original orthosis M (that is, manufacturing a replica). Behind the fact that the idea of "reproduction of the same shape" was not born, the body shape of the patient may change over time, and the post-processing work by hand in order to finally complete the orthosis M (Fig. 2). It is considered that the fact that the process (indicated by T) is inevitably required has a considerable influence.

In view of such a conventional problem, the present inventors have obtained the completed orthosis M by 3D scanning its shape (position information in three-dimensional space) using a non-contact type 3D scanner. By storing the shape data (3D digital data) in the storage medium, an attempt was made to save the original three-dimensional shape of the orthosis M. That is, by storing the digital data of the original three-dimensional shape of the orthosis M and inputting the digital data into the three-dimensional modeling device (orthosis modeling unit 3) to three-dimensionally model the orthosis M, it is completely or abbreviated as the original orthosis M. It was thought that it would be possible to manufacture duplicates of the same shape, and as a result, the manual post-processing work could be omitted or greatly simplified. By realizing the omission or simplification of the post-processing work, the burden on the prosthetist and the like is greatly reduced, and the difference in the skills of the individual prosthetists and the like in the post-processing work is less likely to be affected. It is considered that the occurrence of quality variation is suppressed as compared with the above, and by extension, a duplicate of the prosthetist M can be manufactured at low cost.

However, when an attempt is made to measure the three-dimensional shape of the orthosis M using a non-contact type 3D scanner, the reflected state of the laser beam emitted from the scanner is not good, and the data of the target three-dimensional shape cannot be obtained well. It has been found.

As a result of investigating the cause and conducting various experiments, the present inventors have obtained the following findings.

When an attempt is made to measure the three-dimensional shape of the device M using a non-contact type 3D scanner, the amount of light transmitted through the device M among the laser light emitted from the scanner increases, and a sufficient amount of reflected light can be obtained. However, it was found that many missing parts occurred in the acquired data, making it impossible to capture the data. As a result of diligent studies by the present inventor, it has been confirmed that the main cause of such poor reflection state is closely related to the surface roughness of the orthosis M.

Specifically, in general, the surface of the conventional orthosis M is formed to be as flat (smooth surface) as possible in order to prevent friction with the human body. When the present inventors measured the surface roughness of the conventional orthosis (plastic ankle foot orthosis), the value of Ra 1μ was calculated by the arithmetic mean roughness. The arithmetic mean roughness (Ra) was in accordance with the definition of JIS B0601 (2001), and a white interferometer (WYKOHD3000) manufactured by Veeco was used for this measurement. Specifically, the area of 1 cm × 1 cm of the orthosis M, which is the object to be measured, was arbitrarily measured at 10 places, and the average value was calculated.

On the other hand, in the conventional brace M having such a smooth surface, as described above, when measuring the three-dimensional shape of the brace M using a non-contact type 3D scanner, the laser beam emitted to the brace M The reflection state became worse, and many missing parts were generated, making it impossible to capture data. In response to this phenomenon, the present inventors conducted an experiment in which the surface of a conventional brace was subjected to various processing and the three-dimensional shape of the brace M was measured by a non-contact type 3D scanner. As a result, when the surface roughness of the brace M is made rougher than the above-mentioned normal value (general value), the amount of reflected light of the laser beam radiated to the brace M increases, and a defect portion also occurs. We have come to the knowledge that it will become difficult and data can be imported. Further, it was found that the rougher the surface roughness of the orthosis M is than the above-mentioned normal value (general value), the less likely it is that a defective portion is generated, and the shorter the time required for data acquisition.

On the other hand, the rougher the surface roughness of the brace M than the above-mentioned normal value (general value), the more likely it is that the patient (human body) wearing the brace M will be injured such as skin damage. It turned out that.

In addition, patients who wear the orthosis often have paralyzed sensations such as pain at the site where the orthosis is worn. For example, ankle foot orthoses are often used mainly in patients with central nervous system diseases, especially those with stroke hemiplegia. In such a case, the patient wearing the ankle foot orthosis (orthosis M) having a rough surface may not notice the injury such as an abrasion due to the rough surface, and then the injury becomes large and bleeding. It is possible that you will not notice it visually until such a situation occurs.

In general, the surface roughness of the brace M is in a trade-off relationship from the viewpoint of ease of measurement by a non-contact 3D scanner (laser scanning) and ensuring the safety of the wearer. It turns out that it is necessary to set a suitable value to satisfy.

In view of the above problems, in the present embodiment, the surface roughness of the orthosis M is designed or set in the range of 15 μm to 300 μm. Here, a value of 15 μm to 300 μm is the arithmetic mean roughness (Ra).

According to the orthosis M having a surface roughness in such a numerical range, the patient (the skin of the human body to be worn, etc.) is protected from injury, etc., and the reflected light of the light emitted by the non-contact scanner is transmitted. It is possible to realize both of receiving light and measuring the three-dimensional shape. In other words, the device M having an arithmetic mean roughness of the surface of less than Ra 15 μm cannot be scanned (data captured) by a non-contact 3D scanner. On the other hand, if the orthosis M has an arithmetic mean roughness of the surface exceeding Ra 300 μm, there is a risk of injury to the patient's human body. Therefore, the lower limit of the surface roughness of the orthosis M is Ra 15 μm, and the upper limit is 300 μm.

More detailed contents (critical significance, etc.) regarding the above lower limit value and upper limit value will be described later together with the details of the experimental results conducted by the present inventors.

Hereinafter, each configuration of the orthosis manufacturing system A according to the present embodiment will be described. In the following, as an example, a plastic ankle foot orthosis (hereinafter, simply referred to as an orthosis M) is manufactured by the orthosis manufacturing system A (or by a conventional method), and then a duplicate of the orthosis M is manufactured according to a user's request. A mode of manufacturing will be described. Here, the band Mt (see the completed form of FIG. 2) for fixing the orthosis M to the patient's foot is a general-purpose product and is not subject to manufacturing by this system A.

[Human body shape measurement unit]
The human body shape measuring unit 1 measures the shape of the orthosis mounting portion of the human body using the measuring device, and generates the three-dimensional shape data D1 of the human body.

FIG. 3 is a diagram showing an example of a measuring device.

The measuring device includes, for example, a plurality of camera devices 11a to 11f arranged so that the target object can be imaged from different directions.

The human body shape measuring unit 1 uses a plurality of camera devices 11a to 11f to take an image of a portion of the human body to which the brace is attached. The human body shape measuring unit 1 estimates the three-dimensional shape of the orthosis mounting portion from a plurality of camera images generated by the plurality of camera devices 11a to 11f according to the principle of triangulation (also referred to as photogrammetry). .. The method for estimating the three-dimensional shape is the same as the known method, and detailed description thereof will be omitted here.

When imaging the orthosis-mounted portion of the human body, more preferably, the image is taken with the mark as shown in 12 m in FIG. 3 attached to the surface of the human body. As a result, the surface contour of the human body can be clarified, and the alignment when joining the camera images becomes possible.

However, the human body shape measuring unit 1 may use a plurality of 3D scanner devices instead of the plurality of camera devices 11a to 11f as the measuring device. In this case, the 3D scanner device that irradiates and receives the laser beam for measurement may be arranged at the positions of the camera devices 11a to 11f, or more 3D scanner devices may be arranged.

[Data generation unit for orthosis modeling]
The orthosis modeling data generation unit 2 models the orthosis M based on the three-dimensional shape data D1 of the human body, the model shape data D2 of the orthosis, and the manufacturing history data D3 related to other orthoses manufactured in the past. Shape data D4 is generated (see FIG. 2).

FIG. 4 is a diagram showing an example of data referred to by the orthosis modeling data generation unit 2.

The "model shape data D2" is data that defines the base shape of the orthosis M. The model shape data D2 is, for example, a material for forming an orthosis for each region (for example, a ridged region of the foot, a base region of the toes, etc.) of the orthosis wearing portion of the human body with reference to the average human body. Specifies the thickness and shape of. The model shape data D2 is stored in, for example, the management DB5.

The “modeling shape data D4” is design data (for example, CAD (computer-aided design) data) that defines the shape (including values of thickness and surface roughness) of each part of the orthosis M. The modeling shape data D4 is generated by the orthosis modeling data generation unit 2. The modeling shape data D4 is used as reference data or input data when the orthosis modeling unit 3 three-dimensionally models the orthosis M.

The orthosis modeling data generation unit 2 adapts to the orthosis mounting site of the human body (individual patient) by applying the three-dimensional shape data D1 of the human body of the orthosis wearing target (patient) to the model shape data D2. The modeling shape data D4 is generated. The orthosis modeling data generation unit 2 recognizes the shape of each region of the orthosis mounting portion of the human body from the three-dimensional shape data D1 by using, for example, known template matching or the like, and the orthosis modeling data generation unit 2 recognizes the shape of each region of the orthosis mounting portion of the human body. By applying the shape to the model shape data D2, the modeling shape data D4 of the orthosis M is generated.

In the present embodiment, the surface roughness value included in the modeling shape data D4 is defined as a value in the range of 15 μm to 300 μm as described above. Here, the value of the surface roughness defined does not have to be constant over the entire device M, and depends on the part of the device M from the viewpoint of three-dimensional shape measurement by 3D scanning described later and safety aspects such as skin. May be changed as appropriate. In one example, the value of the surface roughness of the inner surface of the orthosis M, that is, the portion that is in contact with the human body is set to be smaller than the value of the surface roughness of the outer surface of the orthosis M, that is, the portion that is not in contact with the human body. With such a configuration, it is possible to further reduce the risk of injury such as scratches while ensuring the readability of the three-dimensional shape data by 3D scanning.

Further, the orthosis modeling data generation unit 2 is a manufactured orthosis data D3 (for example, a manufactured orthosis similar to the orthosis M to be manufactured) related to the orthosis M manufactured in the past (hereinafter, also referred to as “manufactured orthosis Ma”). By using Ma's manufacturing history data D3) as reference information, the mode of post-processing performed in the past by a prosthetist or the like is reflected in the modeling shape data D4.

Further, in the present embodiment, when the orthosis modeling data generation unit 2 manufactures a duplicate of the "manufactured orthosis Ma", the orthosis modeling data generation unit 2 uses the manufacturing history data D3 (orthosis shape measurement data D5) of the manufactured orthosis Ma as it is. It can be used as modeling shape data D4. In this case, the roughness of the surface of each part of the original product and the mode of post-processing performed in the past (that is, with respect to the original product) by a prosthetist or the like are reflected in the modeling shape data D4 of the duplicate product. It will be.

The “manufacturing history data D3” is the manufacturing history data related to the manufactured orthosis Ma accumulated in the management DB5. The manufacturing history data D3 is, for example, a human body shape data D1 of a patient who wears the manufactured orthosis Ma by assigning an identification number (see A, B, C in FIG. 4) to each orthosis Ma manufactured in the past. , Modeling shape data D4 input to the orthosis modeling unit 3, equipment shape measurement data D5 indicating the final completed shape of the manufactured orthosis Ma measured by the orthosis shape measuring unit 4, and the like are stored in association with each other. ..

Among the manufacturing history data D3, the orthosis shape measurement data D5 indicating the completed shape of the orthosis M is, for example, the amount of processing for each part performed on the manufactured orthosis Ma and the post-processing of the manufactured orthosis Ma. Data such as the difference between the front and rear shapes may be included. For example, in the case of ankle foot equipment, a plurality of parts corresponding to the lateral foot, the fibula head, the lateral malleolus, the fifth metatarsal head, the fifth finger bone head, the medial medial malleolus of the foot, the boat-shaped head, and the first phalange. Data of shape (bending condition, etc.), surface roughness (Ra), presence / absence of deformation of thickness, and amount of deformation may be registered for each of these parts.

FIG. 5 is a flowchart showing an example of the operation of the orthosis modeling data generation unit 2. The flowchart shown in FIG. 5 is a process executed by the CPU of the orthosis modeling data generation unit 2 according to, for example, a computer program.

In step S1, the orthosis modeling data generation unit 2 first acquires the three-dimensional shape data D1 of the human body to which the orthosis is attached from the human body shape measurement unit 1.

In step S2, the orthosis modeling data generation unit 2 acquires the model shape data D2 of the orthosis M from the management DB 5, and applies, for example, the three-dimensional shape data D1 of the human body to the model shape data D2. Then, the above-mentioned modeling shape data D4 of the orthosis M is generated.

In step S3, the orthosis modeling data generation unit 2 extracts the manufacturing history data D3 of the manufactured orthosis Ma similar to the manufacturing target orthosis M from the manufacturing history data D3 stored in the management DB 5.

In addition, when extracting using this similarity or the like, the extraction work may be performed using machine learning (deep learning or the like).

In this step S3, the orthosis modeling data generation unit 2 compares the orthosis shape data D4 generated in step S2 with the orthosis shape measurement data D5 of the manufactured orthosis Ma by, for example, a known method such as template matching. Then, the manufacturing history data D3 (orthosis shape measurement data D5) of the manufactured orthosis Ma having a high degree of shape similarity is extracted. More preferably, the orthosis modeling data generation unit 2 extracts the orthosis shape measurement data D5 of the manufactured orthosis Ma having the highest degree of similarity.

In step S4, the orthosis modeling data generation unit 2 corrects the modeling shape data D4 to be manufactured based on the orthosis shape measurement data D5 in the manufacturing history data D3 extracted in step S3.

In this step S4, the orthosis data generation unit 2 is, for example, in the case of each part of the orthosis data D4 to be manufactured (for example, in the case of the ankle foot orthosis (sole orthosis), the foot portion of the orthosis data D4 to be manufactured. From the shape and thickness of the lateral, peroneal head, lateral malleolus, 5th metatarsal head, 5th phalangeal head, medial foot medial malleolus, boat-shaped head, and 1st phalange, etc. On the other hand, the amount of post-processing performed is added or subtracted. These parts, especially in the ankle prosthetist, are the parts that require more detailed adjustments in order to be worn comfortably by the subject who wears the orthosis, and are the parts that the orthotist or the like makes many adjustments. It is also an important item for this. For these reasons, it may also be used as a weight when performing machine learning (deep learning, etc.).

By such processing, the modeling shape data D4 of the object to be three-dimensionally modeled is generated. After the orthosis modeling data generation unit 2 generates the modeling shape data D4, the manufacturing history data of the orthosis M to be manufactured this time (three-dimensional shape data D1 of the human body, the corrected modeling shape data D4) is sent to the management DB 5. ) Is transmitted, and these data are stored in the management DB 5 with the identification number of the device M and the like. At this point, the shape measurement data (D5) of the orthosis M manufactured this time is blank.

The method by which the orthosis modeling data generation unit 2 extracts the manufacturing history data D3 can be changed in various ways. For example, the orthosis modeling data generation unit 2 may extract the manufacturing history data D3 relating to the orthosis having a high degree of shape similarity based on the three-dimensional shape data D1 of the human body without using the model shape data D2. .. On the other hand, at this time, the orthosis modeling data generation unit 2 may refer to the manufacturing history data D3 arbitrarily selected by the user.

Further, when manufacturing a duplicate of the orthosis Ma manufactured in the past, the orthosis modeling data generation unit 2 does not perform the above-mentioned processes of steps S1 to S4, and simply manufactures the orthosis Ma manufacturing history data D3 (for example, the orthosis). The shape measurement data D5) may be extracted, and the extracted data may be registered as the modeling shape data D4 used by the orthosis modeling unit 3.

[Orthosis modeling department]
The orthosis modeling unit 3 three-dimensionally models the orthosis M using the three-dimensional modeling device 30 based on the modeling shape data D4 generated by the orthosis modeling data generation unit 2.

FIG. 6 is a diagram showing an example of a three-dimensional modeling device 30 connected to a computer of the orthosis modeling unit 3.

The three-dimensional modeling device 30 shown in FIG. 6 is a powder sintering laminated type three-dimensional modeling device. The powder sintering lamination type three-dimensional modeling apparatus 30 is suitable in that three-dimensional modeling of a thermoplastic resin is relatively easy, and in addition, a complicated shape can be relatively easily formed.

The three-dimensional modeling apparatus 30 irradiates the modeling stage 31 arranged in the opening, the powder layer forming portion 32 for forming the powder layer on the modeling stage 31, and the modeling area of the powder layer with laser light to form the modeling. A laser irradiation unit 33 or the like for forming a modeling layer by sintering or melting and solidifying the powder material in the region is provided.

FIG. 7 is a flowchart showing an example of the operation of the orthosis modeling unit 3 according to the present embodiment. The flowchart shown in FIG. 7 is a process executed by the CPU of the orthosis modeling unit 3 according to, for example, a computer program.

In step S11, the orthosis modeling unit 3 creates slice data for setting the modeling area to be formed in each powder layer from the modeling shape data D4 input from the orthosis modeling data generation unit 2.

In addition, when the orthosis modeling unit 3 creates slice data, if there is a portion where the above-mentioned surface roughness value included in the input modeling shape data D4 is out of the range of 15 μm to 300 μm, the slice data You may stop the creation of and display a warning that the modeling shape data D4 should be re-entered. In this case, the CPU, the display unit, and the like of the orthosis modeling unit 3 function as a warning unit to warn when the above-mentioned surface roughness value included in the modeling shape data D4 is out of the range of 15 μm to 300 μm. ..

On the other hand, if the surface roughness value defined in the modeling shape data D4 is in the range of 15 μm to 300 μm in all the portions, the orthosis modeling unit 3 creates slice data and performs the process of step S12.

In step S12, the orthosis modeling unit 3 drives the powder layer forming unit 32 of the three-dimensional modeling device 30 to correspond to the nth layer (the nth layer (bottom layer) defined by the slice data) on the modeling stage 31. ) Form a powder layer. At this time, in the fixture molding unit 3, the surface roughness (arithmetic mean roughness) of the powder layer after the laser melting by the subsequent laser light irradiation (step S13) is a value (Ra 15 μm to 300 μm) specified in the modeling shape data D4. The powder layer forming portion 32 is driven and controlled so as to have a powder layer having a surface roughness in anticipation of becoming (range of). This is in consideration of the fact that the powder layer is melted when the powder layer is irradiated with the laser beam.

In step S13, the orthosis modeling unit 3 drives the laser irradiation unit 33 to irradiate the powder layer formed in step S12 with laser light to sinter or melt and solidify the powder in the modeling region to form the modeling layer. To form.

In step S14, the orthosis modeling unit 3 determines whether the formed modeling layer is the final layer. Then, when the formed modeling layer is not the final layer (step S14: NO), the orthosis modeling unit 3 lowers the modeling stage 31 and again lays a new powder layer on the modeling layer in the process of step S12. Then, the process of step S13 of irradiating the laser to further form the modeling layer is executed. The orthosis modeling unit 3 repeats such a process to model a three-dimensional modeled object. Then, when the formed modeling layer is the final layer (step S14: YES), the orthosis modeling unit 3 ends a series of processes in the flowchart.

By such a flow, the orthosis M having a surface (outer surface and inner surface in contact with the human body) having a roughness of 15 μm to 300 μm is three-dimensionally formed.

In addition, the equipment modeling unit 3 is a stereolithography type three-dimensional modeling device that irradiates a liquid resin with ultraviolet rays to cure it and sequentially laminates it, instead of a powder sintering lamination type three-dimensional modeling device, and sequentially injects a liquefied material. An inkjet type three-dimensional modeling device for laminating, a heat-melting laminating type three-dimensional modeling device for melting a thermoplastic resin at a high temperature and sequentially laminating them, a sheet laminating type three-dimensional modeling device for laminating sheets to form a shape, and the like may be used. Further, as the three-dimensional modeling apparatus, a cutting method such as cutting may be used instead of the laminating method. In any of the three-dimensional modeling devices, the three-dimensional modeling device M is operated so that the surface roughness (arithmetic mean roughness) is in the range of Ra 15 μm to 300 μm.

[Post-processing]
The orthosis M, which has been three-dimensionally modeled by the orthosis modeling unit 3, is post-processed by a prosthetist or the like, if necessary. In the manufacturing method by the conventional method (steps (1) to (7)), as described above in FIG. 1, a prosthetist or the like plastically deforms the orthosis M using a heat gun to post-process the shape or thickness of the orthosis M. Was often done.

On the other hand, in the present embodiment, the shape data (modeling shape data D4) generated by the orthosis modeling data generation unit 2 and input to the three-dimensional modeling apparatus 30 is manually performed by an orthotist or the like. The amount of processing deformation can be included in advance. Therefore, according to the present embodiment, the required correction amount can be made smaller than before. Therefore, the burden on the orthotist and the like and the working time can be reduced, and the variation in cost and quality can be suppressed. In addition, skilled prosthetists and the like can focus on modifying finer or more important parts.

[Orthosis surface treatment unit 6]
Further, as another aspect of the post-processing described above, in the case of making a replica of the orthosis (conventional product) manufactured by the above-mentioned conventional methods (steps (1) to (7)), the surface of the conventional product is subjected to the above-mentioned surface. It is processed by the orthosis surface treatment unit 6 so that the roughness is within the above range.

As the surface treatment method (that is, the roughening method) in the orthosis surface treatment unit 6, any method of mechanical, physical, electrochemical, or chemical treatment may be used. Mechanical methods include blasting and polishing, and physical methods include plasma and laser treatment. Further, as an electrochemical method, there is an alumite treatment, and as a chemical method, there is a wet etching method and the like.

In the present embodiment, the brace surface treatment unit 6 uses an automatic blasting machine (not shown). There are various types of automatic blasting machines, but in one specific example, a work (“orthosis” in this embodiment) is put into a barrel basket, and the work is mixed by the rotation of the barrel basket and polished with a fixed gun. A barrel cage type air blasting device that injects material together with air to perform blasting can be used. By applying such surface processing to the conventional product, it becomes possible to acquire data on the outer shape (three-dimensional shape) of a general orthosis with a 3D scanner, and by extension, a replica of the conventional product can be manufactured at low cost. Can be done.

When using the automatic blasting machine as described above, the degree and state of the surface roughness of the brace M can be variously changed by changing the settings (user settings) such as the processing time and the injection intensity. .. Further, it is considered that the optimum value or the optimum value of the processing time and the injection intensity is different depending on the orthosis M. Therefore, for example, when the surface treatment is completed, the orthosis surface treatment unit 6 transmits setting information such as the treatment time and the injection intensity together with the identification number of the orthosis M, and stores the setting information as the manufacturing history data D3 in the management DB 5. Good (see "Surface Treatment Information" in FIG. 9 described later). With such a configuration, it can be used as reference information when the three-dimensional shape data described later cannot be acquired.

[Brace shape measuring unit 4]
The orthosis shape measuring unit 4 is a conventional orthosis M formed by the orthosis modeling unit 3 (three-dimensional modeling apparatus 30) using a measuring device (3D scanner) or a conventional orthosis M that has been roughened. Measure the shape. In the present embodiment, the surface condition of the brace M is inspected in this step, and when the three-dimensional shape cannot be measured to the extent that a duplicate can be manufactured (when the brace shape measurement data D5 cannot be obtained), the above-mentioned surface treatment is performed. Try to execute the (roughening) process (redo).

Further, in the present embodiment, it is also possible to measure the amount of post-processing performed by a prosthetist or the like based on the step of measuring the three-dimensional shape of the prosthetist M by the prosthetist shape measuring unit 4.

FIG. 8 is a flowchart showing an example of the operation of the orthosis shape measuring unit 4. The flowchart shown in FIG. 8 is a process executed by the CPU of the orthosis shape measuring unit 4 according to, for example, a computer program. Further, FIG. 9 is a diagram illustrating an example of data items stored in the management DB 5 as the device shape measuring unit 4 operates.

In step S21, the orthosis shape measuring unit 4 measures the three-dimensional shape of the orthosis M by using the measuring device. In the present embodiment, the measuring device used by the orthosis shape measuring unit 4 is the plurality of 3D scanners described above with reference to FIG. Although not shown, each 3D scanner is based on a light emitting unit that generates and emits laser light, a sensor unit that receives (receives) reflected waves of the emitted laser light, and light received by the sensor unit. It is equipped with a calculation unit such as a CPU that calculates the distance to the object. In one example, a plurality of 3D scanners having such a configuration are arranged so as to surround the device M (see FIG. 3 and the like). Then, each 3D scanner irradiates the equipment M with the laser light from the light emitting unit, identifies the laser light reflected from the equipment M by the sensor unit, and follows the principle of triangular measurement, and follows the object (equipment M). The distance to the surface) is measured, and the measured distance (hereinafter referred to as “measurement distance”) is output to the orthosis shape measuring unit 4.

In step S22, the orthosis shape measuring unit 4 determines whether or not the shape data of the orthosis M can be acquired (acquired) without the occurrence of a defective portion. In one specific example, this determination is whether or not the measurement distance (that is, the three-dimensional position data of the point cloud constituting the measurement surface of the equipment M assigned to each 3D scanner) is received from all the 3D scanners. Is the standard.

Here, when the brace shape measuring unit 4 receives the measurement distances from all the 3D scanners arranged around the brace M, the brace shape measuring unit 4 can capture the shape data of the brace M without causing a defect (step S22, YES). ), And the process of step S26 described later is executed.

On the other hand, when the measurement distance cannot be received from any one or more 3D scanners arranged around the orthosis M, the orthosis shape measuring unit 4 determines that a defective part has occurred (steps S22, NO), and steps S23. Executes the processing of.

In step S23, the orthosis shape measuring unit 4 determines whether or not the defective portion can be interpolated. In one specific example, the orthosis shape measuring unit 4 applies a preset interpolation program (for example, a program that applies a surface model and a solid model to a polygon having a defective portion to create a 3D mesh of the defective portion). Execute to determine whether or not all the missing parts have been automatically interpolated. During execution of such an interpolation program, the orthosis shape measuring unit 4 may refer to the modeling shape data D4 in the management DB 5, the three-dimensional shape data in the manufacturing history data D3, or the model shape data D2.

Here, when all the defective portions can be automatically interpolated (step S23, YES), the orthosis shape measuring unit 4 generates the three-dimensional shape data of the entire orthosis M by interpolating the shape data of the defective portions (step S24). ), The process proceeds to step S26. In this case, the equipment shape measuring unit 4 (CPU) is a data complementing unit that generates three-dimensional shape data of the entire equipment M by interpolating the shape of the defective portion when a defective portion is generated in the measurement of any of the 3D scanners. Functions as.

On the other hand, when any of the defective parts cannot be interpolated (step S23, NO), the orthosis shape measuring unit 4 identifies the corresponding part of the corresponding 3D scanner and the equipment M, and the shape data is obtained at the part of the defective part. An error indicating that the data could not be obtained is displayed (step S25), and a series of processes is terminated. In this case, the orthosis shape measuring unit 4 (CPU and display unit) interpolates the shape of the display unit that identifies and displays the portion of the orthosis M corresponding to the defective portion when the defective portion occurs, and the shape of the defective portion. It functions as an error display unit that displays an error when it cannot be done. Further, the orthosis shape measuring unit 4 may transmit the information of the corresponding parts of the 3D scanner and the orthosis M that could not be interpolated together with the identification number of the orthosis M and store the information in the management DB 5 as the manufacturing history data D3 (FIG. 9). See "Missing Site Information").

When the defective portion cannot be interpolated as described above, the brace M is returned to the above-described roughening step and then subjected to the measurement flow of the three-dimensional shape of FIG. 8 (step S21) again. NS. According to the present embodiment, since the portion (part) of the orthosis M whose defective portion could not be interpolated is specified (displayed), the roughening step here is replaced with the blasting process described above. Alternatively, the relevant portion of the brace may be manually surface-processed using, for example, a grinder or sandpaper (not shown).

In step S26, the orthosis shape measuring unit 4 transmits the data of the entire three-dimensional shape of the orthosis M (orthosis shape measurement data D5) to the management DB 5 together with the identification number of the orthosis M, and stores it in the management DB 5 as manufacturing history data D3. (See FIGS. 4 and 9).

After that, the manufacturing history data D3 (the above-mentioned "equipment shape measurement data D5") stored in the management DB 5 is input to the orthosis modeling unit 3 as the modeling shape data (D4), and the orthosis M is three-dimensionally modeled by the three-dimensional modeling device 30. By doing so, the orthosis M as a reproduction product that reproduces the three-dimensional shape of the original orthosis M as faithfully as possible is manufactured. Here, the prosthetist M as a replica manufactured by the orthosis modeling unit 3 (three-dimensional modeling apparatus 30) is a minimum of post-processing work performed by an orthotist or the like, such as attaching a band Mt (see FIG. 2). It can be reduced to, and can be manufactured quickly and at low cost.

Further, in the present embodiment, since the management DB 5 stores the information on the three-dimensional shape of the original orthosis M, the orthosis M as a replica is measured by the orthosis shape measuring unit 4 or the like. The process may not be performed, and in this case, the production of the brace M can be further speeded up and the cost can be reduced. On the other hand, from the viewpoint of confirming the accuracy of shape reproduction of the duplicated product (correcting the shaped shape data (D4) input to the orthosis modeling unit 3 in some cases), the orthosis shape is measured for the orthosis M as the duplicated product. A step such as shape measurement by the part 4 may be executed.

Further, when the shape of the orthosis M is finely modified (see the conventional step T in FIG. 1) by post-processing by a manual (orthotist or the like), the three-dimensional shape measurement by the orthosis shape measuring unit 4 (in some cases, the surface treatment described above). ), Then, the work of finely modifying the shape by hand is performed, and the three-dimensional shape is measured again by the orthosis shape measuring unit 4. In this case, the equipment shape measuring unit 4 determines the three-dimensional shape data (D5) of the equipment M acquired in the first three-dimensional shape measurement and the equipment M acquired in the second three-dimensional shape measurement (that is, after the shape is slightly modified). The three-dimensional shape data and the three-dimensional shape data are registered as manufacturing history data D3, respectively (see "equipment shape measurement data D5" and "equipment shape remeasurement data (post-processed)" in FIG. 9).

Further, the orthosis shape measuring unit 4 is based on the three-dimensional shape data of the orthosis M after the post-processing (“equipment shape remeasurement data (post-processed)” in FIG. 9), and the orthosis before the post-processing. By subtracting the three-dimensional shape data of M (“orthosis shape measurement data D5” in the figure), the processing amount for each part in the post-processing is calculated. Subsequently, the orthosis shape measuring unit 4 transmits the data of the processing amount to the management DB 5 together with the identification number of the orthosis M, and stores the data in the management DB 5 as the manufacturing history data D3 (“post-processing data” in FIG. 9). reference).

By performing such processing, in the orthosis manufacturing system A, the history of the processing amount when the orthosis technician or the like post-processes the orthosis M can be sequentially accumulated as the manufacturing history data D3.

As described above, according to the equipment manufacturing system A of the present embodiment in which the equipment M having a surface roughness within a predetermined value is used (manufacturing, surface treatment, shape measurement, etc.), the safety of the wearer and the three-dimensional shape can be determined. Optical measurableness can be ensured and the production of duplicates can be supported.

In the above-described embodiment, an example in which most of the orthosis M is automatically three-dimensionally modeled and manufactured has been described. On the other hand, the brace M of the present embodiment can be manufactured by various other methods. As another example, as described in the step (6) of the conventional example, a film or sheet of a thermoplastic resin (hereinafter, simply referred to as “resin plate”) is pressed against the positive model of the foot type. A method of forming an orthosis M suitable for a foot shape by curing such a resin plate can be mentioned. In this case, a step of surface-processing the surface of the resin plate to a roughness in the numerical range as described above may be added. This surface processing step may be either before or after curing the resin plate.

According to the orthosis manufacturing system A of the present embodiment, when the orthosis M of a certain patient is manufactured, the mode of post-processing performed in the manufactured orthosis Ma based on the manufacturing history data D3 of the manufactured orthosis Ma is determined in advance. The modeling shape data D4 can be generated so as to be reflected. Further, according to the orthosis manufacturing system A of the present embodiment, the amount of post-processing work required by a prosthetist or the like when remanufacturing (reproducing) the orthosis M manufactured in the past of the patient is minimized. can do.

(Other embodiments)
The present invention is not limited to the above embodiment, and various modifications can be considered.

In the above embodiment, an ankle foot orthosis (sole orthosis) is shown as an example of the orthosis M to be manufactured. On the other hand, the orthosis manufacturing system A of the present embodiment includes a crotch orthosis, a long leg orthosis, a knee orthosis, a congenital orthosis, a shoulder orthosis, an elbow orthosis, a long confrontation orthosis, a short confrontation orthosis, a gripping orthosis, a dorsiflexion orthosis, and an MP. Of course, it can be applied to any kind of orthosis such as an extension flexion orthosis and a finger orthosis.

(Experimental result)
The present inventors have produced test products 1 to 17 of orthoses (orthoses with ankle foot limbs) having various surface roughness values by the various manufacturing methods described above, and for each test product, when taking a picture with a 3D scanner. We conducted experiments on data acquisition and whether or not human body damage would occur. The contents and results of this experiment are shown in the table of FIG. 10, and a supplementary explanation will be given below.

The test products 1 to 15 were manufactured by the above-mentioned conventional method, and only the test product 1 was not subjected to post-processing for roughening the surface. The surface roughness (calculated average value, the same applies hereinafter) of the test product 1 without such post-processing was 1 Raμm. On the other hand, the test products 2 to 15 were subjected to the above-mentioned blast treatment and post-processed so that the surface roughness had a value of 10 to 350 Raμm (see the table).

The test product 16 was manufactured by using the above-mentioned manufacturing method of 3D modeling and setting the surface roughness to a value of 200 Raμm (see the table) at the time of 3D modeling.

For the test product 17, the above-mentioned resin plate was cured, and the cured resin plate was surface-treated to produce an orthosis M suitable for the last shape. The surface roughness of the manufactured test product 17 was 200 Raμm.

(Experiment of 3D scanner photography)
In the 3D scanner imaging experiment for the test products 1 to 17, imaging (3D scanning) was performed using a 3D scanner "iSense" manufactured by 3D Systems, and the possibility of data capture and the time required for imaging were tested.

In the table, "◎" in the "Data acquisition" column is an example in which sufficient data can be imported. Specifically, data of 95% or more of the entire measurement site (100% area). Here is an example of how we were able to capture. "○" in the same column is a case where there was a slight defect but there was no practical problem, and it was possible to capture data in an area of 90% or more and less than 95% of the entire measurement site. An example is shown. “Δ” in the same column indicates a case where a defective portion has occurred and the captured data can be used by performing image processing and interpolating the defective portion. Specifically, "Δ" indicates a case in which data in an area of 80% or more and less than 90% of the entire measurement site could be captured. Further, "x" in the same column is an example in which the captured data could not be used because a large number of defective portions were generated and data could not be captured to the extent that the defective portions could be interpolated. Specifically, "x" indicates a case where data can be captured in an area of less than 80% of the entire measurement site.

In the table, "◎" in the "shooting time" column indicates a case where the shooting time was less than 3 minutes. “○” in the same column indicates a case where the shooting time was 3 minutes or more and less than 5 minutes. “Δ” in the same column indicates a case where the shooting time was 5 minutes or more. "-" In the same column indicates a case where data could not be imported.

As shown in the table, in the test products 1 to 5 having a surface roughness of 14 Raμm or less, a large number of defective parts were generated in the data acquired during 3D scanning, and the data could not be captured. On the other hand, in the test product 6 having a surface roughness of 15 Raμm, it took 5 minutes or more to take a picture, but it was possible to take a picture, and by performing image processing and interpolating the defect, the captured data became usable. .. Further, in the test product 7 having a surface roughness of 50 Raμm, although the imaging time took 5 minutes or more, good capture data could be obtained. With the test product 8 having a surface roughness of 100 Raμm, good capture data could be obtained in a certain imaging time. Further, in the test products 9 to 17 having a surface roughness of 200 Raμm or more, sufficient data acquisition could be obtained in a short time. In general, it was found that the better the surface condition of the test product (in this case, "coarse"), the shorter the imaging time can be. Further, it was found that the surface roughness of the test product needs to be 15 Raμm (lower limit value) or more in order to acquire the shape data of the test product by 3D scanning.

(Test for human body damage)
The tests for human body damage of each test product (1 to 17) were carried out as follows. A test product (foot model) is attached to the plantar dorsiflexion repeat tester, and both plantar flexion and dorsiflexion are bent at an angle of 15 °, and such flexion is performed 10,000 times each for plantar flexion and dorsiflexion for testing. The degree of damage to the later foot model was evaluated. In the table, "◎" in the "human body injury" column indicates a case in which the foot model is not damaged and is considered to have no effect on the human body. "○" in the same column indicates a case in which the foot model was slightly damaged, but it is considered that there is no effect on the human body. “△” in the same column indicates a case in which the foot model was slightly damaged, but it is considered that there is no effect on the human body. The "x" in the same column indicates a case where the foot model is severely damaged to the extent that it is considered to have an effect on the human body.

As shown in the table, in the test products 14 and 15 having a surface roughness of 301 Raμm or more, the degree of damage to the foot model is large, and there is a risk of injury when worn on the human body (patient). Was damaged. On the other hand, in the test product 13 having a surface roughness of 300 Raμm, the foot model was damaged, but the damage was such that the risk of injury or the like when worn on the human body is considered to be extremely small. Further, in the test product 11 having a surface roughness of 299 Raμm, the foot model was slightly damaged, but the damage was such that there is no possibility of injury or the like when the foot model is attached to the human body. In addition, in the test products 1 to 10 having a surface roughness of 1 to 250 Raμm, no damage was observed in the foot model, and good results were obtained.

From the above experimental results, it was found that the lower limit of the surface roughness of the orthosis is 15 Raμm and the upper limit is 300 Raμm. That is, in the case of an orthosis having a surface roughness of 15 Raμm to 300 Raμm, the orthosis or the component parts of the orthosis (including the state before completion, hereinafter referred to as “orthosis”) is irradiated with light to obtain the contour of the orthosis. At the time of optical measurement for measuring the position on the three axes for defining, the reflected light of the irradiated light can be measured, and the risk of damaging the skin of the human body to which the orthosis is attached is minimized. be able to.

Although specific examples of the present invention have been described in detail above, these are merely examples and do not limit the scope of claims. The techniques described in the claims include various modifications and modifications of the specific examples illustrated above.

The disclosures of the specifications, drawings and abstracts contained in the Japanese application of Japanese Patent Application No. 2018-188446 filed on October 3, 2018 are all incorporated herein by reference.

1 Human body shape measurement unit 2 Data generation unit for orthosis modeling 3 Orthosis modeling unit (warning unit)
4 Orthosis shape measurement unit (data complement unit, display unit, error display unit)
5 Management DB
6 Orthosis surface treatment unit (orthosis surface treatment device)
30 Three-dimensional modeling device A Orthosis manufacturing system M Orthosis (short leg orthosis)

Claims (15)

An orthosis worn on the human body
The surface has a roughness of 15 μm to 300 μm,
Orthosis. The roughness is an arithmetic mean roughness (Ra).
The orthosis according to claim 1. In the orthosis, the value of the surface roughness of the portion in contact with the human body is smaller than the value of the surface roughness of the portion in contact with the human body.
The orthosis according to claim 1 or 2. The orthosis is an ankle foot orthosis using resin.
The part that comes into contact with the human body is the inner surface of the ankle foot orthosis.
The orthosis according to claim 3. An orthosis manufacturing device that manufactures orthoses worn on the human body.
A three-dimensional modeling portion for three-dimensionally modeling the orthosis so that the surface has a roughness of 15 μm to 300 μm is provided.
Orthosis manufacturing equipment. The three-dimensional modeling unit shapes the orthosis three-dimensionally based on the input modeling shape data.
The modeling shape data includes a value of surface roughness.
The orthosis manufacturing apparatus according to claim 5. A warning unit is provided to warn when the surface roughness value included in the modeling shape data is out of the range of 15 μm to 300 μm.
The orthosis manufacturing apparatus according to claim 6. A device that processes the surface of equipment worn on the human body.
The orthosis is surface-treated so that the surface has a roughness of 15 μm to 300 μm.
Orthosis surface treatment device. The surface treatment is a blast treatment.
The brace surface treatment apparatus according to claim 8. A modeling shape data acquisition unit that acquires modeling shape data related to the shape of the orthosis attached to the human body,
Based on the modeling shape data, the orthosis modeling portion that three-dimensionally models the orthosis so that the surface has a roughness of 15 μm to 300 μm,
To prepare
Orthosis manufacturing system. An orthosis shape measuring unit that irradiates the orthosis that has been three-dimensionally shaped and then subjected to post-processing with light to measure the three-dimensional shape of the orthosis and generate three-dimensional shape data.
A processing amount data generation unit that compares the modeling shape data with the three-dimensional shape data and generates processing amount data related to the difference between the two.
The orthosis manufacturing system according to claim 10. The orthosis shape measuring unit
A 3D scanner that measures the three-dimensional shape of the orthosis to be measured,
When a defect occurs in the measurement of the 3D scanner, a data complement unit that interpolates the shape of the defect and generates three-dimensional shape data.
To prepare
The orthosis manufacturing system according to claim 11. A display unit is provided that identifies and displays the portion of the orthosis corresponding to the defect when the defect occurs.
The orthosis manufacturing system according to claim 12. An error display unit for displaying an error when the shape of the defective portion cannot be interpolated by the data complement unit is provided.
The brace manufacturing system according to claim 12 or 13. The orthosis surface treatment portion for treating the surface of the orthosis so as to have a surface roughness of 15 μm to 300 μm is provided.
The brace manufacturing system according to any one of claims 10 to 14.

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