技术领域technical field
本发明涉及生物陶瓷技术领域，尤其涉及一种生物医用陶瓷人工椎骨植入物。The invention relates to the technical field of bioceramics, in particular to a biomedical ceramic artificial vertebral implant.
背景技术Background technique
人体椎体发生骨折和压缩性骨折，或者受到脊柱结核，及肿瘤侵袭椎体等带来的椎骨破坏时，一般的治疗方法是以自体骨移植和填充骨粉的方式来进行治疗，但自体骨的来源有限，而填充骨粉又存在没有骨支撑及外溢出骨缺损区域的不足。Fractures and compression fractures of the human vertebral body, or vertebral damage caused by spinal tuberculosis and tumor invasion of the vertebral body, the general treatment method is to treat with autologous bone transplantation and bone powder filling, but the autologous bone The source is limited, and there is no bone support and overflow bone defect area to fill the bone powder.
现代的手术治疗方法是完全切除整段病损椎体，并连带去掉两侧之椎间盘，再以椎体融合的形式来治疗患者。而代替这些椎体的人工假体多数是以生物相容性钛金属，这种材料对于人体来说，很明显的缺点就是它无法被人体吸收，也无法诱导骨细胞再生。The modern surgical treatment method is to completely resect the entire damaged vertebral body, remove the intervertebral discs on both sides, and then treat the patient in the form of vertebral body fusion. Most of the artificial prostheses that replace these vertebral bodies are made of biocompatible titanium metal. For the human body, the obvious disadvantage of this material is that it cannot be absorbed by the human body, nor can it induce bone cell regeneration.
因此，现有技术还有待进一步发展。Therefore, prior art still needs further development.
发明内容Contents of the invention
针对上述技术问题，本发明实施例提供了一种生物医用陶瓷人工椎骨植入物，其能够修补人体椎骨并快速增生愈合。In view of the above technical problems, the embodiment of the present invention provides a biomedical ceramic artificial vertebral implant, which can repair human vertebrae and rapidly proliferate and heal.
一种生物医用陶瓷人工椎骨植入物，其中，所述生物医用陶瓷人工椎骨植入物主体由若干微结构单元组成，相邻的微结构单元之间相互连接，使得植入物主体表面和内部形成可供成骨细胞附着及增殖的孔洞结构。A biomedical ceramic artificial vertebral implant, wherein the main body of the biomedical ceramic artificial vertebral implant is composed of several microstructural units, and adjacent microstructural units are connected to each other, so that the surface and interior of the implant main body Form a hole structure for osteoblast attachment and proliferation.
所述的生物医用陶瓷人工椎骨植入物，其中，若干相同微结构单元空间上以三维立体阵列形式均匀排布。In the biomedical ceramic artificial vertebral implant, several identical microstructure units are uniformly arranged in a three-dimensional array in space.
所述的生物医用陶瓷人工椎骨植入物，其中，所述微结构单元整体为三维十字结构，是由六根相同的支柱通过一连接交汇点正交连接而成。The biomedical ceramic artificial vertebral implant, wherein, the microstructure unit as a whole is a three-dimensional cross structure, which is formed by orthogonally connecting six identical pillars through a connecting intersection point.
所述的生物医用陶瓷人工椎骨植入物，其中，所述微结构单元整体边长为300-1000微米。In the biomedical ceramic artificial vertebral implant, the overall side length of the microstructure unit is 300-1000 microns.
所述的生物医用陶瓷人工椎骨植入物，其中，所述生物医用陶瓷人工椎骨植入物主体外周设置有用于维持植入物主体形态稳定的支架。The biomedical ceramic artificial vertebral implant, wherein, the outer periphery of the biomedical ceramic artificial vertebral implant body is provided with a bracket for maintaining the shape stability of the implant body.
所述的生物医用陶瓷人工椎骨植入物，其中，所述支架由实心支撑条连接而成，各支撑条分别对应生物医用陶瓷人工椎骨植入物主体各边沿位置分布。The biomedical ceramic artificial vertebra implant, wherein, the bracket is formed by connecting solid support bars, and each support bar is distributed corresponding to the edge positions of the main body of the biomedical ceramic artificial vertebra implant.
所述的生物医用陶瓷人工椎骨植入物，其中，所述支架的形状由椎体病损区域形状决定，所述支架形状为方形、圆柱形、或半圆锥形。The biomedical ceramic artificial vertebral implant, wherein the shape of the bracket is determined by the shape of the vertebral lesion area, and the shape of the bracket is square, cylindrical, or semi-conical.
所述的生物医用陶瓷人工椎骨植入物，其中，制备微结构单元和支架的材料均采用生物医疗陶瓷，该材料由氧化锆陶瓷、氧化铝陶瓷、生物活性玻璃、羟基磷灰石陶瓷、磷酸三钙、硫酸钙陶瓷中的一种或多种混合而成。The biomedical ceramic artificial vertebral implant, wherein, the materials for preparing the microstructure unit and the support are all biomedical ceramics, and the materials are composed of zirconia ceramics, alumina ceramics, bioactive glass, hydroxyapatite ceramics, phosphoric acid One or more of tricalcium and calcium sulfate ceramics are mixed.
所述的生物医用陶瓷人工椎骨植入物，其中，所述生物医用陶瓷人工椎骨植入物通过3D打印设备制造。The biomedical ceramic artificial vertebral implant, wherein, the biomedical ceramic artificial vertebral implant is manufactured by 3D printing equipment.
本发明的生物医用陶瓷人工椎骨植入物，具备多微孔结构，且采用生物医疗陶瓷材料制备，在修补人体椎骨的同时能够诱导骨细胞快速增生愈合，加之本发明植入物具有被人体吸收的效果，从而真正实现人体椎体疾患的彻底治愈。另外本发明人工椎骨植入物采用3D打印技术制造，可为患者进行定制设计，降低了植入物加工制造难度，也降低了制造成本。The biomedical ceramic artificial vertebral implant of the present invention has a microporous structure and is made of biomedical ceramic materials. It can induce rapid proliferation and healing of bone cells while repairing human vertebrae. In addition, the implant of the present invention has the ability to be absorbed by the human body. The effect, so as to truly realize the complete cure of human vertebral body diseases. In addition, the artificial vertebral implant of the present invention is manufactured by 3D printing technology, which can be customized for patients, reduces the difficulty of implant processing and manufacturing, and also reduces manufacturing costs.
附图说明Description of drawings
图1为本发明具体实施例中生物医用陶瓷人工椎骨植入物的结构示意图。Fig. 1 is a schematic structural view of a biomedical ceramic artificial vertebra implant in a specific embodiment of the present invention.
图2为本发明具体实施例中生物医用陶瓷人工椎骨植入物的微结构单元结构示意图。Fig. 2 is a schematic diagram of the microstructure unit structure of the biomedical ceramic artificial vertebral implant in a specific embodiment of the present invention.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts fall within the protection scope of the present invention.
需要说明的是，当元件被表述“固定于”另一个元件，它可以直接在另一个元件上、或者其间可以存在一个或多个居中的元件。当一个元件被表述“连接”另一个元件，它可以是直接连接到另一个元件、或者其间可以存在一个或多个居中的元件。本说明书所使用的术语“垂直的”、“水平的”、“左”、“右”、“上”、“下”、“内”、“外”、“底部”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。It should be noted that when an element is said to be "fixed" to another element, it may be directly on the other element, or there may be one or more intervening elements therebetween. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or one or more intervening elements may be present therebetween. The terms "vertical", "horizontal", "left", "right", "upper", "lower", "inner", "outer", "bottom", etc. used in this specification indicate orientation or positional relationship Based on the orientation or positional relationship shown in the drawings, it is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a limitation of the invention. In addition, the terms "first", "second", etc. are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.
除非另有定义，本说明书所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本说明书中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是用于限制本发明。本说明书所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terminology used in the description of the present invention in this specification is only for the purpose of describing specific embodiments, and is not used to limit the present invention. The term "and/or" used in this specification includes any and all combinations of one or more of the associated listed items. In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as there is no conflict with each other.
如图1所示的一种生物医用陶瓷人工椎骨植入物，其中，所述生物医用陶瓷人工椎骨植入物主体100由若干微结构单元110组成，相邻的微结构单元之间相互连接，使得植入物主体表面和内部形成可供成骨细胞附着及增殖的孔洞结构。A biomedical ceramic artificial vertebral implant as shown in Figure 1, wherein the biomedical ceramic artificial vertebral implant body 100 is composed of several microstructure units 110, and adjacent microstructure units are connected to each other, A hole structure for osteoblast attachment and proliferation is formed on the surface and inside of the main body of the implant.
进一步的，若干相同微结构单元空间上以三维立体阵列形式均匀排布。Further, several identical microstructure units are uniformly arranged in a three-dimensional array in space.
较佳的是，所述生物医用陶瓷人工椎骨植入物通过3D打印设备制造。这样在打印模型构建时，生物医用陶瓷人工椎骨植入物主体可由一个微结构单元通过三维立体阵列构成：单个微结构单元向三维空间的X轴方向阵列若干数量，以满足X轴长度的要求。单个微结构单元向三维空间的Y轴方向阵列若干数量，以满足Y轴长度的要求。单个微结构单元向三维空间的Z轴方向阵列若干数量，以满足Z轴长度的要求。X、Y、Z方向三维立体阵列组合构成，其阵列数量由椎骨植入物的宏观尺寸所决定。Preferably, the biomedical ceramic artificial vertebral implant is manufactured by 3D printing equipment. In this way, when the printing model is constructed, the main body of the biomedical ceramic artificial vertebral implant can be composed of a microstructure unit through a three-dimensional array: a single microstructure unit is arrayed in a certain number in the X-axis direction of the three-dimensional space to meet the X-axis length requirement. A certain number of individual microstructure units are arrayed in the direction of the Y-axis in the three-dimensional space to meet the requirement of the length of the Y-axis. A certain number of individual microstructure units are arrayed in the direction of the Z-axis in the three-dimensional space to meet the requirement of the length of the Z-axis. The three-dimensional arrays in the X, Y, and Z directions are composed of three-dimensional arrays, and the number of arrays is determined by the macroscopic size of the vertebral implant.
基于3D打印，人工椎骨植入物由多层材料依次堆叠而成。每一层材料可用液体状、粉末状或片状材料依次逐层的列印出来，再将各层材料通过粘合的方式粘接起来即可制造成人工椎骨植入物的实体结构，3D打印后即得到了预成型模型(Green Part)。上述所描述3D打印增材技术不限于熔融沉积制造工艺(FDM)、立体平板印刷(SLA)、数字光处理(DLP)、选择性激光烧结(SLS)、选择性热烧结(SHS)等3D打印增材技术。Based on 3D printing, the artificial vertebral implant consists of multiple layers of materials stacked one after the other. Each layer of material can be printed layer by layer with liquid, powder or sheet materials, and then the layers of materials can be bonded together to manufacture the solid structure of the artificial vertebral implant. 3D printing After that, the preformed model (Green Part) is obtained. The 3D printing additive technology described above is not limited to fused deposition manufacturing (FDM), stereolithography (SLA), digital light processing (DLP), selective laser sintering (SLS), selective thermal sintering (SHS) and other 3D printing Additive technology.
优选实施例中，所述微结构单元整体边长为300-1000微米。In a preferred embodiment, the overall side length of the microstructure unit is 300-1000 microns.
如图2所示的优选实施例中，所述微结构单元整体为三维十字结构，是由六根相同的支柱111通过一连接交汇点正交连接而成。每根立柱呈两端粗中间窄的哑铃状，这结构能够确保相邻的微结构单元具有较大的连接面，确保连接牢固性，从而提升植入物整体结构强度，三维十字结构的微结构单元能够使得植入物主体的表面和内部遍布孔洞，从而为骨生长提供空间。In the preferred embodiment shown in FIG. 2 , the overall microstructure unit is a three-dimensional cross structure, which is formed by orthogonally connecting six identical pillars 111 through a connecting intersection point. Each column is in the shape of a dumbbell with thick ends and a narrow middle. This structure can ensure that the adjacent microstructure units have a larger connection surface and ensure the firmness of the connection, thereby improving the overall structural strength of the implant. The microstructure of the three-dimensional cross structure The cells enable porosity throughout the surface and interior of the implant body, providing room for bone growth.
进一步的，所述生物医用陶瓷人工椎骨植入物主体外周设置有用于维持植入物主体形态稳定的支架200。支架能够保证人工椎骨植入物的物理强度，分散对于多孔微结构的外力作用，确保人工椎骨植入物在术中使用前的形态稳定。具体的，所述支架由实心支撑条连接而成，各支撑条分别对应生物医用陶瓷人工椎骨植入物主体各边沿位置分布。所述支架的形状由椎体病损区域形状决定，所述支架形状为方形、圆柱形、或半圆锥形。Further, the outer periphery of the main body of the biomedical ceramic artificial vertebra implant is provided with a bracket 200 for maintaining the shape stability of the main body of the implant. The bracket can ensure the physical strength of the artificial vertebral implant, disperse the external force on the porous microstructure, and ensure the shape stability of the artificial vertebral implant before use in the operation. Specifically, the bracket is formed by connecting solid support bars, and each support bar is distributed corresponding to each edge position of the main body of the biomedical ceramic artificial vertebral implant. The shape of the bracket is determined by the shape of the lesion area of the vertebral body, and the shape of the bracket is square, cylindrical, or semi-conical.
制备微结构单元和支架的材料均采用生物医疗陶瓷，起为和骨组织一致的无机物材料成分，该材料具体由氧化锆陶瓷、氧化铝陶瓷、生物活性玻璃、羟基磷灰石陶瓷、磷酸三钙、硫酸钙陶瓷中的一种或多种混合而成。The materials for the preparation of microstructure units and scaffolds are all made of biomedical ceramics, which are composed of inorganic materials consistent with bone tissue. The materials are specifically composed of zirconia ceramics, alumina ceramics, bioactive glass, hydroxyapatite ceramics, triphosphate One or more of calcium and calcium sulfate ceramics are mixed.
下面通过实施例进一步阐述本发明生物医用陶瓷人工椎骨植入物的3D打印制造过程：The 3D printing manufacturing process of the biomedical ceramic artificial vertebral implant of the present invention is further set forth below through the examples:
通过电子计算机断层扫描设备对患者病损椎骨CT扫描，以获得患者病损区域的数字化医学图像CT数据。CT scanning of the patient's lesioned vertebrae by computerized tomography equipment to obtain digital medical image CT data of the patient's lesion area.
将数字化医学图像CT数据导入医学图像设计软件(如MINICS，3D slicer等)，对患者病损目标组织解剖结构，进行3D重建为3D虚拟实体。然后依据患者病损椎骨范围和大小进行个体化人工椎骨植入物建模设计。Import digital medical image CT data into medical image design software (such as MINICS, 3D slicer, etc.), and perform 3D reconstruction of the anatomical structure of the patient's lesion target tissue into a 3D virtual entity. Then, according to the range and size of the patient's damaged vertebrae, the modeling and design of individual artificial vertebral implants is carried out.
在本实例中，人工椎骨植入物医疗模型的形状为方形，尺寸为7.2mm×6.9mm×3.0mm。In this example, the artificial vertebral implant medical model has a square shape and a size of 7.2mm x 6.9mm x 3.0mm.
上步设计过程，已经知晓患者病损椎骨范围和大小，以此为依据，可以知晓设计多孔微结构的数量及各个方向阵列的长度。In the previous design process, the range and size of the affected vertebrae of the patient have been known. Based on this, the number of designed porous microstructures and the length of the array in each direction can be known.
在本实例中，多孔微结构单个微结构单元的尺寸为300微米。In this example, the size of a single microstructure unit of the porous microstructure is 300 microns.
单个微结构单元向三维空间的X轴方向阵列若干数量，以满足X轴长度为7.2mm的要求。单个微结构单元向三维空间的Y轴方向阵列若干数量，以满足Y轴长度为6.9mm的要求。单个微结构单元向三维空间的Z轴方向阵列若干数量，以满足Z轴长度为3.0mm的要求。A certain number of individual microstructure units are arrayed in the direction of the X-axis in the three-dimensional space to meet the requirement that the length of the X-axis is 7.2 mm. A certain number of individual microstructure units are arrayed in the direction of the Y axis in the three-dimensional space to meet the requirement that the length of the Y axis is 6.9 mm. A certain number of individual microstructure units are arrayed in the Z-axis direction of the three-dimensional space to meet the requirement that the Z-axis length is 3.0mm.
围绕多孔微结构的周围设计支架。保证人工椎骨植入物的物理强度，分散对于多孔微结构的外力作用，确保人工椎骨植入物在术中使用前的形态稳定。在本实例中，支架依据病损椎骨范围和大小设计方形，其方形的八个边上设计八个截面为正方形的方条连接，其截面方形尺寸为边长是4.2mm。Scaffolds are designed around the perimeter of the porous microstructure. Ensure the physical strength of the artificial vertebral implant, disperse the external force on the porous microstructure, and ensure the shape stability of the artificial vertebral implant before use in the operation. In this example, the bracket is designed in a square shape according to the range and size of the damaged vertebrae, and eight square bars are designed on the eight sides of the square to connect, and the square size of the cross section is 4.2 mm in length.
以上多孔微结构和支架做医疗软件中的布尔运算功能进行2个三维实体相加，合成一个三维立体模型，即为所需要的医疗人工椎骨植入物模型。The above porous microstructure and bracket are used as Boolean operation function in the medical software to add two three-dimensional entities to synthesize a three-dimensional model, which is the required medical artificial vertebral implant model.
在本实例中，所选用的生物医疗陶瓷配方为羟基磷灰石陶瓷(HA)、磷酸三钙(β-TCP)外加混合一些光敏分散剂，以便3D打印成型。In this example, the selected biomedical ceramic formula is hydroxyapatite ceramics (HA), tricalcium phosphate (β-TCP) plus some photosensitive dispersants for 3D printing.
对于本实施例中具有复杂结构的人工椎骨植入物而言，这种层层堆叠的结构使得其制造起来更为容易，本实施例所采用的是SLA增材成型技术。For the artificial vertebral implant with a complex structure in this embodiment, this layered structure makes it easier to manufacture, and the SLA additive molding technology is used in this embodiment.
3D打印得到了预成型模型(Green Part)成型之后，再经过一次高温烧结，把光敏分散剂非生物医疗陶瓷高温烧结掉，最后剩下所需要的生物医疗陶瓷人工椎骨植入物模型。After the preformed model (Green Part) is formed by 3D printing, it is sintered at a high temperature to sinter the photosensitive dispersant non-biological medical ceramics at high temperature, and finally the required biomedical ceramic artificial vertebral implant model is left.
本发明的生物医用陶瓷人工椎骨植入物，具备多微孔结构，且采用生物医疗陶瓷材料制备，在修补人体椎骨的同时能够诱导骨细胞快速增生愈合，加之本发明植入物具有被人体吸收的效果，从而真正实现人体椎体疾患的彻底治愈。另外本发明人工椎骨植入物采用3D打印技术制造，可为患者进行定制设计，降低了植入物加工制造难度，也降低了制造成本。The biomedical ceramic artificial vertebral implant of the present invention has a microporous structure and is made of biomedical ceramic materials. It can induce rapid proliferation and healing of bone cells while repairing human vertebrae. In addition, the implant of the present invention has the ability to be absorbed by the human body. The effect, so as to truly realize the complete cure of human vertebral body diseases. In addition, the artificial vertebral implant of the present invention is manufactured by 3D printing technology, which can be customized for patients, reduces the difficulty of implant processing and manufacturing, and also reduces manufacturing costs.
可以理解的是，对本领域普通技术人员来说，可以根据本发明的技术方案及本发明构思加以等同替换或改变，而所有这些改变或替换都应属于本发明所附的权利要求的保护范围。It can be understood that those skilled in the art can make equivalent replacements or changes according to the technical solutions of the present invention and the concept of the present invention, and all these changes or replacements should belong to the protection scope of the appended claims of the present invention.
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| CN201810258310.1ACN108420573A (en) | 2018-03-27 | 2018-03-27 | A kind of artificial vertebral implant of biomedical ceramics |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810258310.1ACN108420573A (en) | 2018-03-27 | 2018-03-27 | A kind of artificial vertebral implant of biomedical ceramics |
| Publication Number | Publication Date |
|---|---|
| CN108420573Atrue CN108420573A (en) | 2018-08-21 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810258310.1APendingCN108420573A (en) | 2018-03-27 | 2018-03-27 | A kind of artificial vertebral implant of biomedical ceramics |
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| CN (1) | CN108420573A (en) |
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| CN113631121A (en)* | 2019-03-29 | 2021-11-09 | 卡尔·莱宾格医疗技术有限责任两合公司 | Implant consisting of base material infiltrated with biologically active donor material and method of making the same |
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| CN208677653U (en)* | 2018-03-27 | 2019-04-02 | 深圳德智达科技有限公司 | A kind of artificial vertebral implant of biomedical ceramics |
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| Date | Code | Title | Description |
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| SE01 | Entry into force of request for substantive examination | ||
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| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication | Application publication date:20180821 |