A 3D printing manufacturing method for personalized custom auricle orthosis

Abstract

The present invention relates to the technical field of medical devices, and discloses a 3D printing manufacturing method for a personalized auricle orthosis, which collects data from the patient's ear to make an electronic model, and then uses 3D printing to print the auricle orthosis. The present invention uses 3D printing technology to print the auricle orthosis in one piece, abandoning the method of assembling multiple parts in the prior art, avoiding the complexity and time-consuming problems of parts assembly. In addition, the process of making the auricle orthosis in the present application does not require the production of a mold, which reduces the cost of auricle orthosis production, and the manufacturing process is simple and low in difficulty, which is suitable for industrial production.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a 3D printing manufacturing method for a personalized customized auricle orthosis. Background Art

[0002] In recent years, the incidence of auricular deformity in newborns in China has reached 43.5%. After one year old, 16.1% of the ear deformities still cannot return to normal and need treatment, otherwise the deformity will accompany them for life. There are two treatment methods: surgery and orthotics. Surgery is expensive and will cause pain to patients, while orthotics are low-cost and less painful. Therefore, orthotics have become the first choice for most patients. Most of the existing correctors on the market are mass-produced using traditional injection molding methods. They are not targeted, uncomfortable to wear, and the treatment effect is not ideal. In recent years, a few auricular orthotics have been produced using 3D printing technology, but there are also some problems.

[0003] For example, the patent "An auricle orthosis and its preparation method" with publication number CN108371576A, the auricle orthosis prepared therein is assembled from multiple parts, not an integrated molding structure, and the assembly steps are relatively complicated; the patent "An auricle morphology orthosis and its preparation method" with publication number CN111067684A directly obtains the mold through 3D printing, and the orthosis needs to be made through the mold. Therefore, the orthosis product cannot be directly obtained through 3D printing.

[0004] Therefore, in view of the shortcomings of the existing technology, it is necessary to provide a 3D printing manufacturing method for a personalized customized auricle orthosis to overcome the shortcomings of the existing technology. Summary of the invention

[0005] In view of the deficiencies in the production process of the existing auricle orthosis mentioned in the background technology, the present invention provides a 3D printing manufacturing method for a personalized customized auricle orthosis, which has the advantages of one-piece molding and customized production, and solves the problems raised in the above background technology.

[0006] The present invention provides the following technical solution: a 3D printing manufacturing method for a personalized auricle orthosis, characterized in that it comprises the following steps:

[0007] Step 1: Use a high-precision 3D scanner to collect 3D data of the patient's auricle and generate a 3D model;

[0008] Step 2: Transfer the model to Magics and use the model repair function of Magics to partially repair defects such as incomplete reverse triangles, bad edges, wrong contours, gaps, holes, shells, and interfering shells;

[0009] Step 3: Based on the above model and combined with the treatment goal, UG NX10.0 was used to establish a target ear model, and an orthosis model with an ear cavity was generated by intersection and Boolean subtraction with the target ear model;

[0010] Step 4: Import the designed orthosis model into the software of the FORM3 printer, and select medical transparent flexible photosensitive resin material for 3D printing;

[0011] Step 5: The printed auricle orthosis is first cleaned with anhydrous ethanol, then supported and shaped using an orthosis support, and then cured under ultraviolet light;

[0012] Step 6: Polish the support of the orthosis, and the surface roughness Ra value should be ≤0.5μm.

[0013] Preferably, the three-dimensional scanner in step 1 should have an error of ≤1 micron, and should rotate around the ear to scan and collect complete auricle data.

[0014] Preferably, the medical transparent flexible photosensitive resin in step 4 should have a hardness of ≥90HA and a light transmittance of ≥80%.

[0015] Preferably, the 3D printing parameters in step 4 are: layer thickness 25-100 μm, laser power 250 mW, spot size ≤85 μm, and model placement angle 45°.

[0016] Preferably, the duration of the anhydrous ethanol cleaning in step 5 is 3 to 5 minutes, and the duration of the ultraviolet curing is 20 to 30 minutes.

[0017] The present invention has the following beneficial effects:

[0018] 1. The present invention uses 3D printing technology to print the auricle orthosis in one piece, abandoning the method of assembling multiple parts in the prior art, avoiding the complexity and time-consuming problems of parts assembly. In addition, the process of making the auricle orthosis in the present application does not require the production of a mold, which reduces the cost of producing the auricle orthosis, and the manufacturing process is simple and low in difficulty, which is suitable for industrial production.

[0019] 2. The present invention controls the 3D printing parameters of the auricle orthosis by designing an electronic version of the mold, and there is no physical mold. Therefore, auricle orthosis that matches the ear shapes of different patients can be designed to increase the accuracy of the auricle orthosis, thereby improving the correction effect of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Attached Figure 1 This is a schematic diagram of the 3D printing model arrangement of the present invention. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] The medical transparent flexible photosensitive resin used in the embodiment of the present invention has a hardness of 90HA, a light transmittance of 80%, and a required laser wavelength of 405nm.

[0023] Embodiment 1:

[0024] The obtained 3D printed customized auricle orthosis has one-piece molding, good flexibility, dimensional accuracy up to 0.2%, and surface roughness Ra of 0.12μm.

[0025] The preparation process includes the following steps:

[0026] Step 1: Use a high-precision 3D scanner to collect 3D data of the patient's auricle and generate a 3D model;

[0027] Step 2: Transfer the model to Magics and use the model repair function of Magics to partially repair defects such as incomplete reverse triangles, bad edges, wrong contours, gaps, holes, shells, and interfering shells;

[0028] Step 3: Based on the above model and combined with the treatment goal, use UG NX10.0 to establish a target ear model, and generate an orthosis model with an ear cavity by intersecting and Boolean subtracting the target ear model.

[0029] Step 4: Import the designed orthosis model into the software of the FORM3 printer and perform 3D printing with the following parameters: layer thickness 25μm, laser power 250mW, spot size 85μm, model placement angle 45°, and medical transparent flexible photosensitive resin as the material;

[0030] Step 5: The printed auricle orthosis is first cleaned with anhydrous ethanol for 3 minutes, then supported with an orthosis support, and finally cured in ultraviolet light for 20 minutes;

[0031] Step 6: Polish the support of the orthosis, and the surface roughness Ra value is 0.12μm.

[0032] Embodiment 2:

[0033] A 3D printed customized auricle orthosis was obtained, which was integrally formed, had good flexibility, a dimensional accuracy of up to 0.3%, and a surface roughness Ra of 0.18 μm.

[0034] The preparation process includes the following steps:

[0035] Step 1: Use a high-precision 3D scanner to collect 3D data of the patient's auricle and generate a 3D model;

[0036] Step 2: Transfer the model to Magics and use the model repair function of Magics to partially repair defects such as incomplete reverse triangles, bad edges, wrong contours, gaps, holes, shells, and interfering shells;

[0037] Step 3: Based on the above model and combined with the treatment goal, use UG NX10.0 to establish a target ear model, and generate an orthosis model with an ear cavity by intersecting and Boolean subtracting the target ear model.

[0038] Step 4: Import the designed orthosis model into the software of the FORM3 printer and perform 3D printing with the following parameters: layer thickness 100μm, laser power 250mW, spot size 85μm, model placement angle 45°, and medical transparent flexible photosensitive resin as the material;

[0039] Step 5: The printed auricle orthosis is first cleaned with anhydrous ethanol for 5 minutes, then removed from the support, and finally cured in ultraviolet light for 30 minutes;

[0040] Step 6: Polish the support of the orthosis, and the surface roughness Ra value is 0.18μm.

[0041] At room temperature, the average breaking strength and elongation of the 3D printed customized auricle orthosis are 16.15 MPa and 219.5%, respectively. In addition, the surface roughness, hardness, bending, compression performance and transparency all meet the technical requirements of T / CAMDI068-2021 "Additive Manufacturing Ear Pressure Orthosis".

[0042] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0043] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A 3D printing manufacturing method for a personalized auricle orthosis, characterized in that: The following steps are involved: Step 1: Use a high-precision 3D scanner to collect 3D data of the patient's auricle and generate a 3D model; Step 2: Transfer the model to Magics and use the model repair function of Magics to partially repair the incomplete reverse triangles, bad edges, wrong contours, gaps, holes, shells, and interfering shell defects; Step 3: Based on the above model and the treatment goal, UG NX10.0 was used to establish a target ear model, and an orthosis model with an ear cavity was generated by intersection and Boolean subtraction with the target ear model; Step 4: Import the designed orthosis model into the software of the FORM3 printer, and select medical transparent flexible photosensitive resin material for 3D printing; Step 5: The printed auricle orthosis is first cleaned with anhydrous ethanol, then supported and shaped using an orthosis support, and then cured under ultraviolet light; Step 6: Polish the support of the orthosis to a surface roughness of Ra ≤ 0.5 μm.

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