Prefabricated patient-customized implant and manufacturing method thereof

Abstract

The present invention relates to a prefabricated patient-customized implant inserted into and fixed to a bone defect site, wherein one end of the bone defect site is formed in a joint. The prefabricated patient-customized implant comprises: a joint connection part having an external shape corresponding to a first defect end of the one end of the bone defect site; and a fixing part integrally formed with the joint connection part and detachably coupled to a part connected to a second defect end of the other end of the bone defect site.

Description

Prefabricated patient-specific implant and method for manufacturing the same

[0001] Research related to this patent was conducted with the support of the National Cancer Center (Research Project Name: Public Interest Cancer Research Project, Project Name: Development of 3D Printing-Based Assembly Implant (II), Project Unique Number: 2410600) under the auspices of the Ministry of Health and Welfare.

[0002] The present invention relates to a prefabricated patient-specific implant and a method for manufacturing the same.

[0003] In general, implants are developed to minimize inconvenience in human life by replacing human bones or teeth with artificial ones.

[0004] Bone defects can occur due to trauma such as traffic accidents or industrial accidents, or due to diseases such as tumors, congenital malformations, and osteomyelitis. Recently, efforts to actively reconstruct bone defects after removing bone tumors have been increasing.

[0005] Previously, to treat these bone defects, bones from cadaveric donors were used, or prefabricated implants were used.

[0006] However, existing methods utilizing cadaveric donor bone have long-term strength issues, and prefabricated, modular implants can damage joints adjacent to bone defects. While customized implants have recently been utilized, their non-prefabricated nature increases the size of the implant insertion surgery, and even revision surgeries often require complete replacement of the entire implant.

[0007] The purpose of the present invention is to provide a prefabricated patient-specific implant and a method for manufacturing the same.

[0008] The present invention relates to a prefabricated patient-specific implant that is inserted and fixed into a bone defect site, wherein one end of the bone defect site is formed in a joint, and includes a joint connecting portion having an outer shape corresponding to a first defect end of one end of the bone defect site; and a fixing portion that is formed integrally with the joint connecting portion and is detachably connected to a part that is connected to a second defect end of the other end of the bone defect site.

[0009] The above fixed portion is extended in one direction, and the cross-sectional area of ​​the joint connection portion in the vertical direction of the one direction may be larger than the cross-sectional area of ​​the fixed portion.

[0010] The above joint connection portion may have a receiving space formed surrounding the joint, and a plurality of fastening holes may be formed in at least a portion of the joint connection portion for screw fastening with the first defective end portion.

[0011] The connection between the above part and the above fixed part can be made by at least one of forced fitting and screw fastening.

[0012] The connection between the above part and the fixing part is made by screw fastening, and the fixing part may include a fitting groove for fitting with the part; and a guide groove having threads formed on upper and lower surfaces so as to be coupled with the part via the screw.

[0013] The above-mentioned fitting groove accommodates the end of the part and is formed long in a direction perpendicular to the one direction, thereby limiting the movement of the part in the extension direction of the guide groove.

[0014] The above guide groove is formed in a direction perpendicular to the above one direction, and the extension direction of the guide groove and the extension direction of the fitting groove can be perpendicular.

[0015] The above implant is made of a titanium alloy material and is formed through 3D printing processing based on an image of the bone defect area, and the 3D printing processing can be performed using at least one of a laser and an electron beam.

[0016] The present invention relates to a method for manufacturing a patient-specific implant that is inserted and fixed into a bone defect site, the method including a step of forming an implant that is combined with a bone defect site through 3D printing based on an image of the bone defect site, wherein the implant comprises: a joint connecting portion having an outer shape corresponding to a first defect end of one end of the bone defect site, one end of the bone defect site being formed in a joint; and a fixing portion that is formed integrally with the joint connecting portion and is detachably connected to a part that is connected to a second defect end of the other end of the bone defect site.

[0017] The image of the above bone defect area is obtained through computed tomography (CT) and / or magnetic resonance imaging (MRI), and the 3D printing process can be performed using at least one of a laser and an electron beam.

[0018] The above joint connecting portion and the first defective end portion are connected by screw fastening, and the screw fastening can be performed through a plurality of fastening holes formed in at least a portion of the joint connecting portion.

[0019] The above-mentioned fixed part may include a fitting groove for fitting with the part and a guide groove having screw threads formed on upper and lower surfaces to be fitted with the part.

[0020] When forming the screw thread, the screw-joining direction formed by the screw thread is parallel to the stacking direction during the 3D printing process, and among the two surfaces of the screw thread formed by the 3D printing process, the lower surface screw thread may be formed first, and then the upper surface screw thread may be formed.

[0021] When forming the above screw thread, the beam speed of the laser may be 100 mm / s to 2400 mm / s, and the beam power of the laser may be 10 W to 340 W.

[0022] When forming the above screw thread, the diameter of the tip circle formed by the upper screw thread and the lower screw thread may be 0.05 to 0.4 mm.

[0023] According to the present invention, a prefabricated patient-specific implant and a method for manufacturing the same are provided.

[0024] Figure 1 shows the bone defect area.

[0025] Figure 2a is a perspective view of an implant according to one embodiment of the present invention.

[0026] Figure 2b is a cross-sectional perspective view of an implant according to one embodiment of the present invention;

[0027] Figures 3a and 3b illustrate a combined form of an implant and parts according to one embodiment of the present invention.

[0028] Figure 3c illustrates a screw thread formed in a guide groove of an implant according to one embodiment of the present invention.

[0029] Figure 4 shows a state in which an implant according to one embodiment of the present invention is combined with a part and applied (inserted and fixed) to a bone defect area.

[0030] Figure 5 shows a state in which the joint connection part of an implant according to one embodiment of the present invention is applied (screw-fastened) as a patient-tailored fit to the first defect end of one end of a bone defect area.

[0031] Figure 6 is a flowchart showing a method for manufacturing an implant according to one embodiment of the present invention.

[0032] Figures 7a to 7d show normally formed screw threads in an example of manufacturing an implant.

[0033] Figures 8a to 8d illustrate abnormally formed screw threads in an example of manufacturing an implant.

[0034] Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings.

[0035] The attached drawings are merely examples intended to further illustrate the technical concepts of the present invention, and therefore, the scope of the present invention is not limited to the attached drawings. For the purposes of illustration, the thickness and length of each part in the attached drawings may be exaggerated.

[0036] In this specification, relative terms such as below, above, upper, lower, horizontal, or vertical may be used to describe the relationship of one component, layer, or region to another component, layer, or region as depicted in the drawings. These terms encompass not only the directions indicated in the drawings but also other directions of the device.

[0037] Hereinafter, embodiments of the present invention will be described with reference to drawings schematically illustrating ideal embodiments. In these drawings, for example, the sizes and shapes of components may be exaggerated for convenience and clarity of explanation, and variations in the illustrated shapes may be expected during actual implementation. Therefore, embodiments of the present invention are not limited to the specific shapes of the regions illustrated in this specification.

[0038] Referring to the drawings, an implant (100) according to one embodiment of the present invention is configured to be inserted into a bone defect area (10) caused by bone necrosis or surgical bone removal due to a traffic accident, congenital malformation, osteomyelitis, tumor, etc.

[0039] Each component of an implant (100) according to an embodiment of the present invention will be described in detail with reference to FIGS. 1 to 3a, 3b, and 3c.

[0040] FIG. 1 shows a bone defect area, specifically, a bone defect area of ​​the femur adjacent to the knee joint, FIGS. 2a and 2b are perspective views of an implant according to an embodiment of the present invention, FIGS. 3a and 3b show a form in which an implant and parts are combined according to an embodiment of the present invention, and FIG. 3c shows a screw thread formed in a guide groove of an implant according to an embodiment of the present invention.

[0041] Referring to Fig. 1, the bone defect area (10) includes a first defect end (11) formed adjacent to the joint and a second defect end (12) formed in the defective bone other than the joint area.

[0042] In the following description, the bone defect area (10) refers to an area that is caused by bone necrosis or removal due to a traffic accident, congenital deformity, osteomyelitis, tumor, etc.

[0043] The first defective end (11) and the second defective end (12) have different shapes and sizes depending on the object and / or the cut shape.

[0044] The implant (100) includes a joint connection part (110) and a fixing part (120).

[0045] In one embodiment of the present invention, the implant (100) is formed in a form in which a portion is solid and another portion is porous, but is not limited thereto. In another embodiment, the implant (100) may be formed in a form without an internal empty space, and in yet another embodiment, the implant (100) may be formed in a form in which a portion of the internal space is empty.

[0046] Referring to FIGS. 2a and 2b, the joint connection portion (110) can have an outer shape corresponding to the first defect end (11) of the bone defect portion (10), and as a result, can be formed into a patient-customized design.

[0047] The fixed part (120) is elongated in one direction, and the cross-sectional area of ​​the joint connection part (110) in the one-way vertical direction is formed to be larger than the cross-sectional area of ​​the fixed part (120). Here, 'one-way' means the extension direction of the fixed part (120). In addition, the fixed part (120) may have a standardized shape that can be complementarily combined with the part (200).

[0048] The joint connection part (110) is formed with a plurality of fastening holes (111) that can be gripped by a bone adjacent to the joint.

[0049] A receiving space surrounding the joint is formed in the joint connection portion (110), and the receiving space is formed as a space large enough to sufficiently surround the joint depending on the size and shape of the first defective end portion (11).

[0050] The joint connection part (110) is screw-connected to the first defective end part (11) through the fastening hole (111).

[0051] The fixed part (120) is formed integrally with the joint connection part (110) and is detachably connected to a part (200) that is connected to the second defective end (12) of the other end of the bone defect area (10).

[0052] In the following description, one end of the 'part (200)' is connected to a fixed part (120), and the other end is fixed to the second defective end (12), and in one example, may be inserted and fixed. In addition, the other end of the part (200) is connected to an additional part (210), and the additional part (210) may be fixed to the second defective end (12).

[0053] The connection between the part (200) and the fixed part (120) can be achieved by either forced fitting (direct impact pressure connection) or screw fastening, and in one embodiment of the present invention, the part (200) and the fixed part (120) are connected by screw fastening.

[0054] In one embodiment of the present invention, the part (200) utilizes a commercially available ready-made product, but is not limited thereto. In another embodiment, it may be custom-made according to the shape of the patient's bone defect area (10).

[0055] The fixed part (120) includes a fitting groove (121) and a guide groove (122).

[0056] Referring to FIGS. 3a and 3b, the fitting groove (121) is fitted with the part (200), accommodates the protruding end of the part (200), and is formed to be long in one direction and in the vertical direction, thereby restricting movement in the extension direction of the guide groove (122) of the part (200) and rotational movement with one direction as the central axis.

[0057] The guide groove (122) has screw threads formed with upper and lower surfaces so as to be coupled with the part (200) via a screw. Here, the 'upper and lower screw threads' mean, among the screw threads with two surfaces formed in the stacking direction of the 3D printing process during the manufacturing of the implant (100) described later, an upper screw thread formed in which the shape of the cross-section being stacked gradually decreases in size compared to the cross-section stacked immediately before when considering the stacking direction, and a lower screw thread formed in which the size of the cross-section newly stacked thereafter increases.

[0058] In this embodiment, the guide groove (122) is formed in one direction and in a vertical direction, and the extension direction of the guide groove (122) and the extension direction of the fitting groove (121) are vertical, but are not limited thereto. In another embodiment, the guide groove (122) may be formed in one direction and in a horizontal direction.

[0059] Referring to Fig. 3c, the formation of screw threads is performed through a layered manufacturing method using laser processing, or by performing separate post-processing on an implant (100) formed through a layered manufacturing method. For example, in one embodiment of the present invention, screw threads may be formed using a laser printer using selective laser melting, but the present invention is not limited thereto.

[0060] In each of the configurations described above, the material of the implant (100) may be a titanium alloy. More specifically, the material of the implant (100) may be Ti6A14V, but is not limited thereto.

[0061] Hereinafter, with reference to FIGS. 4 and 5, the method of using the implant (100) of the present invention and the combination and function of each component will be described.

[0062] FIG. 4 shows a state in which an implant according to one embodiment of the present invention is applied (inserted and fixed) to a bone defect site by being combined with a part, and FIG. 5 shows a state in which an articular joint of an implant according to one embodiment of the present invention is applied (screw-fastened) to a first defect end of a bone defect site as a patient-tailored fit.

[0063] First, the soft tissues of the skin and muscles on both ends, including the bone defect area (10), are incised so that the first defect end (11) and the second defect end (12) can be exposed completely so that the patient's bone defect area (10) can be fully exposed.

[0064] In one embodiment of the present invention, the first defect end (11) is fixed in a patient-specific manner, and the second defect end (12) is fixed in a standardized manner using a commercially available product as a part (200), but this is not limited thereto. In another embodiment, the first defect end (11) and the second defect end (12) may be fixed in a patient-specific manner depending on the shape or location of the bone defect area (10).

[0065] The ends of the first defect end (11) and the second defect end (12) are usually blocked by bone marrow and cancellous bone and may be subject to bone atrophy. After peeling off the soft tissue and periosteum from the cross-section of the first defect end (11) and the second defect end (12), the cross-sections of the bone and joint areas are cleaned.

[0066] To ensure smooth connection between the ends of the first defective end (11) and the second defective end (12) and the joint connecting part (110) and the part (200), a portion of the cortical bone is ground or removed.

[0067] Thereafter, as shown in Fig. 4, an additional part (210) is combined with the part (200), and the additional part (210) is inserted into the bone marrow of the second defective end (12) and fixed. Here, the additional part (210) is inserted into the bone marrow by applying pressure using a hammer, but is not limited thereto.

[0068] Next, as shown in Fig. 5, the joint connection part (110) and the first defective part (11) are connected through screw fastening. Screw fastening is performed by surrounding the joint through the receiving space of the joint connection part (110) and then inserting screws into a plurality of fastening holes formed in the joint connection part (110).

[0069] Thereafter, the implant (100) and the part (200) are connected by screw fastening. Specifically, the part (200) is connected by screw fastening with a fitting groove (121) formed in the fixing part (120), and is tightly connected to the fixing part (120) by screw fastening with a guide groove (122) formed with screw threads having upper and lower surfaces.

[0070] In the present invention, the part (200) and the additional part (210) are first connected to the second defective end (12), and the implant (100) is connected to the first defective end (11), and then the implant (100) and the part (200) are connected through screw fastening, but this is not limited thereto.

[0071] In another embodiment, the implant (100) and the first defect end (11) may be connected first, and then the part (200) connected to the additional part (210) may be inserted into the second defect end (12), and then the implant (100) and the part (200) may be connected. The order of mutual connection between the implant (100), the part (200), and the bone defect end (11, 12) is not limited.

[0072] Hereinafter, a method for manufacturing an implant according to an embodiment of the present invention will be described with reference to FIGS. 6 to 8a, 8b, 8c, and 8d. FIG. 6 is a flowchart showing a method for manufacturing an implant according to an embodiment of the present invention, FIGS. 7a to 7d show normally formed screw threads in an example of manufacturing an implant, and FIGS. 8a to 8d show abnormally formed screw threads in an example of manufacturing an implant.

[0073] First, an image of the bone defect area (10) is acquired. (S100) The image of the bone defect area (10) is determined based on a patient image obtained through computed tomography (CT) and / or magnetic resonance imaging (MRI) to determine the area to be resected or trimmed, thereby confirming the final bone defect area (10).

[0074] Next, based on the obtained image, an implant (100) is formed through 3D printing processing to have an outer shape corresponding to the bone defect area (10). (S200)

[0075] At this point, the areas that will require patient-specific fixation and those that will require standardized fixation are determined. For the standardized fixation, pre-made parts are selected and reverse-engineered. Some of the fixation parts can include patient-specific features, and both ends can be machined to provide a patient-specific form.

[0076] In one embodiment of the present invention, the formation of the implant (100) is performed through 3D printing processing using a laser, but is not limited thereto. In another embodiment, the formation of the implant (100) may be performed through 3D printing processing using an electron beam. In yet another embodiment, the implant (100) may be formed through post-processing after 3D printing processing, and in this case, the post-processing may be performed through a cutting processing method for precise processing of detailed portions of the implant (100).

[0077] Specifically, the implant (100) is manufactured as a single unit through 3D printing, including a joint connection (110) that connects to the first defective end (11) and a fixing part (120) that connects to a part (200) that is inserted and fixed to the second defective end (12).

[0078] An upper screw thread and a lower screw thread are formed in the guide groove (120) within the fixed portion (120). Here, the screw thread is formed as continuous 3D printing processing is performed based on the stacking direction during the manufacturing of the implant (100), and includes an upper screw thread formed as the shape of the cross-section being stacked in the screw thread having two faces gradually decreases in size compared to the cross-section that was stacked immediately before, and a lower screw thread formed as the cross-section that is newly stacked thereafter increases in size.

[0079] In one embodiment of the present invention, the screw thread forming direction is shown as being parallel to the stacking direction, but this is not limited thereto. The stacking direction in which the screw thread is formed is maintained as parallel as possible to prevent distortion during manufacturing.

[0080] The shape and size of the upper and lower threads vary depending on the laser's energy concentration, which is determined by the laser's beam speed and beam power output. The energy concentration can be obtained using the following formula:

[0081]

[0082] In the above formula, ED is the energy directivity of the laser (J / mm 3 ) , BS (Beam Speed) represents beam speed (mm / s) and BP (Beam Power) represents beam power (W).

[0083] Specifically, the laser energy concentration during thread formation is 10 to 80 J / mm2, 15 to 75 J / mm2, 20 to 70 J / mm2, 25 to 65 J / mm2, or 30 to 60 J / mm2.

[0084] The beam speed of the laser for thread formation is 100 mm / s to 2400 mm / s, 200 mm / s to 2300 mm / s, 300 mm / s to 2200 mm / s, 400 mm / s to 2100 mm / s or 500 mm / s to 2000 mm / s, and the beam power of the laser is 10 W to 340 W, 20 W to 330 W, 30 W to 320 W, 40 W to 310 W or 50 W to 300 W.

[0085] The diameter of the circle of the thread tip created by the thread formation is 0.05 mm to 0.4 mm, 0.1 mm to 0.3 mm, 0.15 mm to 0.35 mm or 0.2 mm to 0.3 mm. Here, the thread tip means the tip created by the upper thread and the lower thread.

[0086] Hereinafter, with reference to FIGS. 7a to 7d and FIGS. 8a to 8d, the formation of screw threads according to laser output conditions will be described in detail through specific experimental examples.

[0087] Example 1

[0088] We used a selective laser melting laser printer, the Dpert M200, a SLM method printer released by Daegun Tech in Korea, and used the titanium alloy Ti6A14V as the raw material. At this time, the laser output conditions for thread formation were set to 1,000 mm / s, the laser beam speed to 100 W, and the laser beam power to 100 W, so that thread processing was performed under a laser energy concentration of 55.56 J / mm2.

[0089] Example 2

[0090] The same laser printer and raw materials as in Example 1 were used, and the laser beam speed was set to 1,500 mm / s, the laser beam power was set to 100 W, and the screw processing was performed with the laser energy concentration being 37.04 J / ㎣.

[0091] Example 3

[0092] The same laser printer and raw materials as in Example 1 were used, and the laser beam speed was set to 1,500 mm / s, the laser beam power was set to 150 W, and the screw processing was performed with the laser energy concentration being 55.56 J / mm2.

[0093] Comparative Example 1

[0094] The same laser printer and raw materials as in Example 1 were used, and the laser beam speed was set to 1,750 mm / s, the laser beam power was set to 100 W, and the screw processing was performed with the laser energy concentration at 31.75 J / ㎣.

[0095] Comparative Example 2

[0096] The same laser printer and raw materials as in Example 1 were used, and the laser beam speed was set to 750 mm / s, the laser beam power was set to 150 W, and the screw processing was performed with the laser energy concentration being 111.11 J / mm2.

[0097] Comparative Example 3

[0098] The same laser printer and raw materials as in Example 1 were used, and the laser beam speed was set to 500 mm / s, the laser beam power was set to 200 W, and the screw processing was performed with the laser energy concentration being 222.22 J / mm2.

[0099] Experimental example

[0100] The shapes of the upper and lower screw threads generated by the examples and comparative examples were confirmed. In addition, the diameter of the circle at the tip of the screw thread formed by the upper and lower screw threads was measured.

[0101] The measurement results are shown in Table 1 below.

[0102] Whether or not normal upper threads are formed Whether or not normal lower threads are formed Diameter of the tip circle (mm) Example 1 OO0.35 Example 2 OO0.2 Example 3 OO0.3 Comparative Example 1 OX0.5 Comparative Example 2 OX0.6 Comparative Example 3 OX1.0

[0103] As described in Table 1, it was confirmed that upper and lower screw threads were normally formed in the screw processing according to the laser conditions of Examples 1 to 3. Hereinafter, a “normally formed screw thread” means that the two faces of the formed screw thread are straight, forming a sharp tip. On the other hand, an “abnormally formed screw thread” means that at least one of the two faces of the formed screw thread is not straight, or is uneven (has a protruding portion), failing to form a sharp tip.

[0104] In contrast, in Comparative Examples 1 to 3, it can be confirmed that the upper threads were formed normally, while the lower threads were formed abnormally. In other words, it can be seen that the formation of abnormal lower threads is the main cause of the failure of overall thread formation, and that controlling the process conditions for forming them is more important.

[0105] Looking at Figures 7a to 7c, when thread processing is performed under conditions where the laser beam speed is 1,000 mm / s to 1,500 mm / s and the laser beam power is 100 W to 150 W, both the upper thread and the lower thread are formed normally. In addition, as shown in Figure 7d, when the lower thread is formed normally, it can be confirmed that the diameter of the circle of the thread tip formed by the upper thread and the lower thread is 0.4 mm or less, and the tip is formed sharply.

[0106] On the other hand, when thread processing is performed under conditions where the laser beam speed exceeds 1,000 mm / s to 1,500 mm / s or the laser beam power exceeds 100 W to 150 W, as shown in FIGS. 8a to 8c, it can be seen that the downward thread is formed abnormally. In addition, as shown in FIG. 8d, when the downward thread is formed abnormally as above, it can be confirmed that the diameter of the circle of the thread tip formed by the upper thread and the downward thread is 0.4 mm or more, and the tip is not formed sharply.

[0107] The above-described examples serve as illustrative examples of the present invention and are not intended to limit the scope of the present invention. Those skilled in the art will readily appreciate the potential for various modifications and implementations of the present invention. Therefore, the technical scope of the present invention should be defined by the appended claims.

Claims

1. In a prefabricated patient-customized implant that is inserted and fixed into a bone defect area, One end of the above bone defect portion is formed in a joint, and the joint connection portion has an outer shape corresponding to the first defect end of the one end of the above bone defect portion; and A patient-specific implant comprising a fixing part that is formed integrally with the joint connection part and detachably connected to a part connected to the second defective end of the other end of the bone defect area; 2. In paragraph 1, The above fixed part is extended in one direction, A prefabricated patient-customized implant in which the cross-sectional area of ​​the joint connection portion in the vertical direction of the above one direction is larger than the cross-sectional area of ​​the fixing portion.

3. In paragraph 2, The above joint connection part has a receiving space formed surrounding the joint, A prefabricated patient-specific implant having a plurality of fastening holes formed in at least a portion of the above joint connection portion for screw fastening with the first defective end portion.

4. In paragraph 1, A patient-customized, prefabricated implant in which the above-mentioned parts and the above-mentioned fixing part are joined by at least one of forced fitting and screw fastening.

5. In paragraph 4, The connection between the above part and the above fixed part is made by screw fastening, The above fixed part, A fitting groove for fitting with the above part; and A patient-customized implant comprising a guide groove having upper and lower surfaces formed with screw threads to be coupled with the part through the screw.

6. In paragraph 5, A prefabricated patient-customized implant in which the above-mentioned insert bone accommodates the end of the above-mentioned part and is formed long in a direction perpendicular to the above-mentioned one direction, thereby restricting the movement of the above-mentioned part in the extension direction of the above-mentioned guide groove.

7. In paragraph 5, The above guide home is formed in the direction perpendicular to the above one direction, A prefabricated patient-customized implant in which the extension direction of the above guide groove and the extension direction of the above fitting bone are perpendicular.

8. In paragraph 1, The above implant is made of titanium alloy, It is formed through 3D printing processing based on the image of the above bone defect area. The above 3D printing process is a prefabricated patient-specific implant performed using at least one of a laser and an electron beam.

9. A method for manufacturing a patient-specific implant that is inserted and fixed into a bone defect area, It includes a step of forming an implant that is combined with the bone defect area based on an image of the bone defect area through 3D printing processing, The above implant, A method for manufacturing an assembly-type patient-tailored implant, comprising: a joint connecting portion having an outer shape corresponding to a first defect end of one end of the bone defect portion, wherein one end of the bone defect portion is formed in a joint; and a fixing portion that is formed integrally with the joint connecting portion and detachably connected to a part connected to a second defect end of the other end of the bone defect portion.

10. In paragraph 9, Images of the above bone defect area are obtained through computed tomography (CT) and / or magnetic resonance imaging (MRI). A method for manufacturing a patient-specific implant, wherein the above 3D printing process is performed using at least one of a laser and an electron beam.

11. In paragraph 9, The above joint connection portion and the first defective end portion are connected by screw fastening, A method for manufacturing a patient-specific implant, wherein the screw fastening is performed through a plurality of fastening holes formed in at least a portion of the above joint connection part.

12. In paragraph 9, The above fixed part, A method for manufacturing a prefabricated patient-customized implant, comprising a guide groove having screw threads formed on upper and lower surfaces to be coupled with the above-mentioned part and a fitting groove for fitting with the above-mentioned part.

13. In paragraph 12, When forming the above screw thread, The screw-joining direction formed by the above screw thread is parallel to the stacking direction during the 3D printing process, A method for manufacturing a custom-made implant for a patient, wherein among the two surfaces of the screw thread formed by the above 3D printing process, the lower screw thread is formed first and then the upper screw thread is formed.

14. In paragraph 10, When forming the above screw thread, The beam speed of the above laser is 100 mm / s to 2400 mm / s, A method for manufacturing a prefabricated patient-specific implant having a beam power of 10 W to 340 W of the laser.

15. In paragraph 14, When forming the above screw thread, A method for manufacturing a custom-made implant having a diameter of a tip formed by the upper screw thread and the lower screw thread of 0.05 to 0.4 mm.

Images