A porous personalized implant and a method of manufacturing the same

Abstract

This invention discloses a porous personalized implant and its manufacturing method. The porous personalized implant includes an abutment and an implant body. The abutment is disposed on top of the implant body and connected to it via a neck. A threaded, porous layer is formed directly on the outer surface of the implant body. The porous layer is helical and has a non-uniform curved surface structure, resulting in an uneven surface. A porous support region is also provided on the outer surface of the neck, passing through the neck and communicating with the porous layer on the outer surface of the implant body. The porous personalized implant of this invention is integrally molded. The porous structure adopts the G-surface structure of the three-period minimal surface, solving the stress shielding and stress concentration problems of existing dental implants. Furthermore, it shortens the surgical cycle while reducing damage to the surface treatment layer during implantation, improving the osseointegration performance of the implant and meeting the needs of different patients.

Description

Technical Field

[0001] This invention relates to the field of dental implant technology, specifically to a porous personalized implant. Background Technology

[0002] Traditional implants employ a two-segment structure, resulting in long surgical cycles and the need for multiple surgeries. Their elastic modulus is much greater than that of natural human bone, which can easily cause "stress shielding" and "stress concentration" problems after implantation, ultimately leading to implantation failure. Making them hollow or porous can improve this problem to some extent. However, ordinary porous structures, such as square porous structures, cannot flexibly change their porosity and pore size, failing to meet the needs of different patients. Furthermore, the threaded structure used in current implant technology has a pitch of approximately 0.6 mm, which is relatively small and can damage the surface treatment layer during implantation, reducing bone integration. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention aims to provide an integrated, porous, personalized implant with a G-curved porous structure and a large pitch.

[0004] A porous personalized implant includes an abutment and an implant body. The abutment is located on top of the implant body and connected to it via a neck. The outer surface of the implant body has threads and a porous layer. The porous layer is directly generated on the surface of the implant body and is spiral-shaped. The width of the porous layer is 1 mm. The porous layer has a non-uniform curved surface structure and is uneven on the surface of the implant body. A porous support area is also provided on the outer surface of the neck. This porous support area passes through the neck and is connected to the porous layer on the outer surface of the implant body. The porous personalized implant body is integrally formed. The porous structure of the porous layer and the porous support area both adopt the G-surface structure of the three-period minimal surface.

[0005] Furthermore, the base is truncated cone-shaped, with a height of 4-6 mm, a diameter of 3-5 mm on the end face of the base near the top of the neck, and a diameter of 2-4 mm on the end face of the base away from the top of the neck.

[0006] Furthermore, the neck is formed by two truncated cones joined together at the bottom. The height of the neck is 2.3-3.3 mm. The central diameter of the neck is larger than the diameter of the end face of the abutment near the top of the neck and the diameter of the end face of the implant near the bottom of the neck. The central diameter of the neck is 4-6 mm. There is a smooth transition between the abutment and the neck.

[0007] Furthermore, the implant is cylindrical with a smooth transition between the implant and the neck. The diameter of the implant is 3-5 mm, the length is 8-12 mm, and the overall length of the implant is 14.3-21.3 mm.

[0008] Furthermore, the shape of the porous support area is an approximate hexagon with the middle dimension being larger than the dimensions at both ends. The maximum width of the middle area is 1.3-1.8mm, the width at both ends is 1-1.5mm, and the distance between the top and bottom ends is 2-3mm. Alternatively, the shape of the porous support area is a rectangle with a length of 2-3mm and a width of 1.3-1.8mm.

[0009] Furthermore, the implicit function expression formula for the G-surface structure is F. Gyroid =

[0010] sin(ax)cos(ay)+sin(ay)cos(az)+sin(az)cos(ax), where, F Gyroid G is the surface function; x, y, z are the x, y, z axis coordinates corresponding to the rectangular coordinate system; a is a constant that controls the period of the surface; by adjusting the parameter a in the formula, the period of the single structure can be adjusted, thereby controlling the pore size and porosity of the porous structure, and thus controlling the overall elastic modulus of the porous personalized implant.

[0011] Furthermore, the average pore size of both the porous layer and the porous support region is 600-800 μm, and the porosity is 63-77%.

[0012] Furthermore, the thread is designed on the implant with a pitch of 2mm, 3.75 turns, a thread height of 0.5mm, and the direction of the thread is clockwise or counterclockwise. The shape of the thread is a reverse support shape, and the direction and angle of the thread are consistent with those of the porous layer.

[0013] Furthermore, the bottom of the porous personalized implant has rounded corners with a radius of 1mm.

[0014] Furthermore, the porous personalized implants are made of Ti6Al4V or pure titanium.

[0015] Furthermore, the manufacturing method of porous personalized implants adopts 3D printing technology for one-piece molding.

[0016] A method for manufacturing porous personalized implants, used to manufacture the aforementioned implants, comprises the following steps:

[0017] S1: Use CT scanning to scan the mandible in the oral cavity to obtain the corresponding CT data, and determine the implant parameters based on the obtained CT data scan results;

[0018] S2: Based on the implant parameters in S1, a three-dimensional model of the implant is created using three-dimensional modeling software;

[0019] S3: Use the parametric modeling module in 3D modeling software to create the G-surface model of TPMS;

[0020] S4: Using 3D printing modeling software, the G-surface model in S3 is set in the implant 3D model in S2 to complete the model building of the porous personalized implant.

[0021] S5: Mesh the 3D model of the porous personalized implant designed in S4 using finite element analysis software;

[0022] S6: Use finite element analysis software to perform finite element analysis on the three-dimensional model of the porous personalized implant designed in S5. Add material properties to the three-dimensional finite element model of the porous personalized implant in sequence, set the analysis steps, set the load and boundary conditions according to the actual situation, and finally calculate and analyze the biomechanical properties of the porous implant. According to the simulated structure of the finite element analysis, the designed porous personalized implant can meet the usage requirements by adjusting the various parameters of the implant or the period of the G-surface element structure.

[0023] S7: Using 3D printing technology, the finished product of the porous personalized implant is printed, and then subjected to acid washing, powder removal, surface treatment and disinfection.

[0024] The beneficial effects of this invention are as follows:

[0025] 1) The structure of alternating threads and porous layers is adopted to increase the pitch and reduce the number of thread layers. This allows the implant to reduce the friction between the threads and the natural bone during implantation, thereby retaining more surface treatment layers and further improving the bone integration performance of the implant.

[0026] 2) The multi-porous personalized implant is a one-piece structure, that is, a one-piece implant. Compared with the two-piece implant, the one-piece implant can be implanted in only one surgery, which can effectively shorten the implantation surgery cycle and reduce the risks caused by the need for multiple surgeries.

[0027] 3) The threads of the multi-hole personalized implant are reverse support threads. Compared with commonly used V-shaped threads, rectangular threads, support threads, etc., the reverse support threads can make the stress distribution more uniform when the implant is under force. In addition, the reverse support threads have a horizontal top, which can resist stronger tensile forces and improve the initial stability of implantation.

[0028] 4) The porous structure of the porous layer adopts the G-surface structure in the three-period minimal surface. Due to the structural characteristics of the G-surface, it has a better ability to promote bone growth. At the same time, the porous layer can reduce the overall elastic modulus of the implant. By adjusting the porosity and pore size of the porous structure, the elastic modulus of the implant can be changed to meet the needs of different patients, thus achieving the effect of personalized implants. It also reduces implantation failure caused by "stress shielding" and further improves the success rate of the implant in this invention.

[0029] 5) A porous support area is set in the neck and connected to the porous layer, which facilitates the removal of residual powder from 3D printing. This reduces stress concentration in the implant neck and also solves the problem of powder accumulation during 3D printing of implants. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the external structure of the implant of the present invention;

[0031] Figure 2 This is a cross-sectional view of the implant of the present invention;

[0032] Figure 3 This is a schematic diagram of the G-surface structure;

[0033] Figure 4 This is a schematic diagram of the D-surface structure;

[0034] Figure 5 This is a schematic diagram of the P-surface structure;

[0035] Figure 6 Schematic diagrams of cross-sections of V-shaped, rectangular, support-shaped, and anti-support-shaped thread shapes;

[0036] In the figure: 1. Abutment; 2. Implant; 3. Thread; 4. Porous layer; 5. Rounded corner; 6. Porous support area; 7. Neck; 8. G-surface structure; 9. D-surface structure; 10. P-surface structure; 11. V-shaped thread structure; 12. Rectangular thread structure; 13. Support-shaped thread structure; 14. Anti-support-shaped thread structure. Detailed Implementation

[0037] The present invention will be further described below with reference to specific embodiments. The embodiments described in this specification are merely supplementary explanations of the inventive concept and are intended to help those skilled in the art to further understand the invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the inventive concept, and these all fall within the protection scope of the present invention.

[0038] Example 1

[0039] This embodiment provides a porous personalized implant, such as Figures 1-2As shown, the implant includes a base 1 and an implant body 2. The base 1 is positioned on top of the implant body and connected to the implant body 2 via a neck 7. The outer surface of the implant body 2 has threads 3 and a porous layer 4. The porous layer 4 is directly formed on the surface of the implant body 2, with a width of 1 mm. The porous layer 4 has a non-uniform curved surface structure and is uneven on the surface of the implant body 2. A porous support region 6 is also provided on the outer surface of the neck 7. This porous support region 6 passes through the neck 7 and connects to the porous layer 4 on the outer surface of the implant body 2. The porous personalized implant is integrally formed. The porous structure of both the porous layer and the porous support region adopts the G-surface structure of a three-period minimal surface.

[0040] The abutment 1 is shaped like a frustum, with a height of 4-6 mm. The diameter of the end face of the abutment 1 near the top of the neck 7 is 3-5 mm, and the diameter of the end face of the abutment 1 away from the top of the neck 7 is 2-4 mm. The neck 7 is formed by two frustums joined together at the bottom, with a height of 2.3-3.3 mm. The center diameter of the neck 7 is larger than the diameter of the end face of the abutment 1 near the top of the neck 7 and the diameter of the end face of the implant 2 near the bottom of the neck 7. The center diameter of the neck 7 is 4-6 mm. There is a smooth transition between the abutment 1 and the neck 7. The implant 2 is cylindrical, with a smooth transition between the implant 2 and the neck 7. The diameter of the implant 2 is 3-5 mm, and the length is 8-12 mm. The overall length of the implant is 14.3-21.3 mm.

[0041] The porous support region 6 is approximately hexagonal in shape, with a central dimension larger than the two end dimensions. The maximum width of the central region is 1.3-1.8 mm, the width of the two end regions is 1-1.5 mm, and the distance between the top and bottom ends is 2-3 mm. The average pore size of the porous support region 6 is 600-800 μm, and the porosity is 63-77%. The porous structure of the porous support region 6 is composed of several Triple Periodic Minimal Surface (TPMS) monolithic structures arranged and combined. A Triple Periodic Minimal Surface refers to a minimal surface that extends infinitely in three independent directions in space. The average curvature at any point on the minimal surface is zero. There are various types of Triple Periodic Minimal Surfaces, including G (Gyroid), D (Diamond), and P (Primitive) surface structures, such as... Figures 3-5 As shown, different surface structures have different properties.

[0042] The porous structure constituting the porous layer 4 is also composed of several TPMS monomer structures arranged and combined. Since the G-curved surface structure has a smoother connection, which is suitable for the growth and adhesion of tissue cells, in this invention, the TPMS monomer structures constituting the porous layer 4 and the porous scaffold region 6 are both G-curved surface structures to ensure the connectivity of the pore channels. Furthermore, the average pore size of the porous layer 4 and the porous scaffold region 6 are both 600-800 μm, and the porosity is both 63-77%.

[0043] Among them, such as Figure 3 As shown, since the structural characteristics of TPMS are not easily expressed in the form of explicit functions (i.e., Y = F(x)), they are usually expressed in the form of implicit functions (i.e., F(x,y,z) = 0). The implicit function expression formula for the G-surface structure is F... Gyroid =sin(ax)cos(ay)+sin(ay)cos(az)+sin(az)cos(ax), where, F Gyroid Let G be the surface function; x, y, z are the x, y, z axis coordinates corresponding to the rectangular coordinate system; a is a constant that controls the period of the surface. By adjusting the parameter a in the formula, the period of the monolithic structure can be adjusted, thereby controlling the pore size and porosity of the porous structure. In turn, the overall elastic modulus of the porous personalized implant can be controlled to meet the needs of different patients. Ordinary monolithic scaffold structures are not conducive to controlling their porosity and cannot be suitable for the needs of patients in different situations.

[0044] In this embodiment, thread 3 is provided on the implant 2 with a pitch of 2mm, 3.75 turns, and a thread height of 0.5mm. The direction of thread 3 is clockwise. Figure 6 As shown, the commonly used implant thread types at present are mainly V-shaped threads 11, rectangular threads 12, support threads 13, and reverse support threads 14. The implant thread 3 in this invention is reverse support shaped. The reverse support thread structure can make the stress distribution of the implant more uniform and increase the initial stability of implantation. Among them, referring to Figure 1 As shown, in this embodiment, the spiral direction and angle of the thread and the porous layer are consistent.

[0045] In addition, such as Figure 1 As shown, in this embodiment, the bottom of the implant 2 is provided with a rounded corner 5, wherein the radius of the rounded corner 5 is 1mm. By setting the rounded corner 5, soft tissue can be cut and the implant can be inserted. The porous personalized implant is made of Ti6Al4V and is integrally formed using 3D printing technology.

[0046] Example 2

[0047] The porous personalized implant in this invention provides another option based on the one described in Example 1.

[0048] The porous support area 6 is rectangular in shape, with a length of 2-3 mm and a width of 1.3-1.8 mm. The thread 3 is counterclockwise. The porous personalized implant is made of pure titanium.

[0049] Example 3

[0050] This embodiment three provides a method for manufacturing porous personalized implants, used to manufacture the described implants, with the following specific steps:

[0051] S1: Use CT scanning to scan the mandible in the oral cavity to obtain the corresponding CT data, and determine the implant parameters based on the obtained CT data scan results;

[0052] S2: Based on the implant parameters in S1, a three-dimensional model of the implant is created using three-dimensional modeling software;

[0053] S3: Use the parametric modeling module in 3D modeling software to create the G-surface model of TPMS;

[0054] S4: Using 3D printing modeling software, the G-surface model in S3 is set in the implant 3D model in S2 to complete the model building of the porous personalized implant.

[0055] S5: Mesh the 3D model of the porous personalized implant designed in S4 using finite element analysis software;

[0056] S6: Use finite element analysis software to perform finite element analysis on the three-dimensional model of the porous personalized implant designed in S5. Add material properties to the three-dimensional finite element model of the porous personalized implant in sequence, set the analysis steps, set the load and boundary conditions according to the actual situation, and finally calculate and analyze the biomechanical properties of the porous implant. According to the simulated structure of the finite element analysis, the designed porous personalized implant can meet the usage requirements by adjusting the various parameters of the implant or the period of the G-surface element structure.

[0057] S7: Using 3D printing technology, the finished product of the porous personalized implant is printed, and then subjected to acid washing, powder removal, surface treatment and disinfection.

[0058] The porous personalized implant of this invention achieves a reduction in the overall elastic modulus of the implant and the neck region by setting a continuous porous layer on the outer surface of the implant and setting a porous scaffold region on the outer surface of the neck region, which is connected to the porous layer on the outer surface of the implant through the neck. This makes the elastic modulus of the implant match that of the natural human bone, reducing the effects of "stress shielding" and "stress concentration" and improving the mechanical properties of the implant. Furthermore, the porous structure adopts a G-curve structure, and the overall elastic modulus of the implant can be adjusted by adjusting the parameters in the formula to meet the needs of different patients. At the same time, the connection between the porous scaffold region and the porous layer can effectively solve the problem of powder accumulation in the porous scaffold region inside the implant caused by additive manufacturing technology.

[0059] The porous personalized implant of this invention is an integrated structure, namely a one-piece implant. The implant part is designed with an alternating spiral structure of threads and porous layers, with a large pitch and few thread turns. This can reduce the damage to the surface treatment layer during implantation while ensuring good initial stability of the implant, thus giving it better bone integration performance.

[0060] The porous personalized implant of this invention can effectively improve the mechanical properties of the implant to meet the needs of different patients, accelerate the bone integration speed, shorten the implantation surgery cycle of the implant of this invention, and thus improve the implantation success rate.

Claims

1. A porous personalized implant, characterized in that, The porous personalized implant is integrally formed, including an abutment (1) and an implant (2). The abutment (1) is set on the top of the implant (2) and connected to the implant (2) through a neck (7). The outer surface of the implant (2) is provided with threads (3) and a porous layer (4). The porous layer (4) is directly generated on the surface of the implant (2) and is spiral. The threads (3) and the porous layer (4) are alternately arranged, and the spiral direction and angle of the threads (3) and the porous layer (4) are consistent. The base (1) and the neck (7) are provided with a porous support area (6). The porous support area (6) passes through the neck (7) and is connected to the porous layer (4) on the outer surface of the implant (2). The porous structure of the porous layer (4) and the porous support area (6) both adopt the G-surface structure (8) in the three-period minimal surface. The implicit function expression formula for the G-surface structure is F. Gyroid = sin(ax)cos(ay)+ sin(ay)cos(az) +sin(az)cos(ax) , where, F Gyroid G is the surface function; x, y, z are the x, y, z axis coordinates corresponding to the rectangular coordinate system; a is a constant that controls the period of the surface; by adjusting the parameter a in the formula, the period of the single structure can be adjusted, thereby controlling the pore size and porosity of the porous structure, and thus controlling the overall elastic modulus of the porous personalized implant.

2. The porous personalized implant according to claim 1, characterized in that: The base (1) is truncated cone-shaped, with a height of 4-6 mm. The diameter of the end face of the base (1) near the top of the neck (7) is 3-5 mm, and the diameter of the end face of the base (1) away from the top of the neck (7) is 2-4 mm.

3. The porous personalized implant according to claim 1, characterized in that: The neck (7) is formed by splicing two truncated cones on the bottom surface. The height of the neck (7) is 2.3-3.3 mm. The central diameter of the neck (7) is greater than the diameter of the end face of the abutment (1) near the top of the neck (7) and the diameter of the end face of the implant (2) near the bottom of the neck (7). The central diameter of the neck (7) is 4-6 mm. The abutment (1) and the neck (7) are smoothly transitioned.

4. The porous personalized implant according to claim 1, characterized in that: The implant (2) is cylindrical, with a smooth transition between the implant (2) and the neck (7). The diameter of the implant (2) is 3-5 mm, the length is 8-12 mm, and the overall length of the implant is 14.3-21.3 mm.

5. A porous personalized implant according to claim 1, characterized in that: The middle dimension of the porous support area (6) is larger than the dimensions at both ends. The maximum width of the middle area is 1.3-1.8mm, the width at both ends is 1-1.5mm, and the distance between the upper and lower ends is 2-3mm. Alternatively, the porous support area (6) may be rectangular in shape, with a length of 2-3mm and a width of 1.3-1.8mm.

6. A porous personalized implant according to claim 1, characterized in that: The average pore size of the porous layer (4) and the porous support region (6) is 600-800µm, and the porosity is 63-77%.

7. A porous personalized implant according to claim 1, characterized in that: The thread (3) is set on the implant (2) with a pitch of 2mm, the number of turns is 3.75, the height of the thread (3) is 0.5mm, the direction of the thread (3) is clockwise or counterclockwise, and the shape of the thread (3) is a reverse support thread structure.

8. A porous personalized implant according to claim 1, characterized in that: The bottom of the implant (2) is rounded (5).

9. A method for manufacturing porous personalized implants, characterized in that, The specific steps for manufacturing the porous personalized implant as described in any one of claims 1-8 are as follows: S1: Use CT scanning to scan the mandible in the oral cavity to obtain the corresponding CT data, and determine the implant parameters based on the obtained CT data scan results; S2: Based on the implant parameters in S1, a three-dimensional model of the implant is created using three-dimensional modeling software; S3: Use the parametric modeling module in 3D modeling software to create the G-surface model of TPMS; S4: Using 3D printing modeling software, the G-surface model in S3 is set in the implant 3D model in S2 to complete the model building of the porous personalized implant. S5: Mesh the 3D model of the porous personalized implant designed in S4 using finite element analysis software; S6: Use finite element analysis software to perform finite element analysis on the three-dimensional model of the porous personalized implant designed in S5. Add material properties to the three-dimensional finite element model of the porous personalized implant in sequence, set the analysis steps, set the load and boundary conditions according to the actual situation, and finally calculate and analyze the biomechanical properties of the porous personalized implant. Based on the simulated structure of the finite element analysis, adjust the various parameters of the implant or the period of the G-surface element structure to make the designed porous personalized implant meet the usage requirements. S7: Using 3D printing technology, the finished product of the porous personalized implant is printed, and then subjected to acid washing, powder removal, surface treatment and disinfection.

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