技术领域technical field
本发明涉及一种头骨替代装置及其制备方法，具体涉及一种3D打印的头骨替代装置及其制备方法。The invention relates to a skull replacement device and a preparation method thereof, in particular to a 3D printed skull replacement device and a preparation method thereof.
背景技术Background technique
头盖骨作为传递外部冲击到大脑的介质，对于维持人的生命安全具有重要的作用。头盖骨受到外物挤压及撞击造成的损伤是临床医疗中常见的颅骨外伤疾病。全世界范围内，每年由于车辆碰撞和运动行为导致的创伤性脑损伤事故达数百万。头盖骨受到损伤后不可恢复，因此对头盖骨替代物的研究至关重要。As a medium for transmitting external shocks to the brain, the skull plays an important role in maintaining the safety of human life. Injury caused by extrusion and impact of foreign objects on the skull is a common cranial trauma disease in clinical medicine. Worldwide, traumatic brain injury accidents due to vehicle crashes and sports activities account for millions of accidents each year. The cranium cannot be restored after injury, so research on cranial replacements is of paramount importance.
现有的头盖骨替代物无法满足患者缺损部位的精细化要求，使大脑组织得不到充分保护，存在经常因为不匹配导致功能障碍的问题。Existing cranial replacements cannot meet the detailed requirements of the patient's defect site, so that the brain tissue is not fully protected, and there are often problems of dysfunction due to mismatch.
发明内容Contents of the invention
本发明的目的是为了解决现有的头盖骨替代物无法满足患者缺损部位的精细化要求，使大脑组织得不到充分保护，存在经常因为不匹配导致功能障碍的问题，进而提供一种3D打印的头骨替代装置及其制备方法。The purpose of the present invention is to solve the problem that the existing skull substitutes cannot meet the refinement requirements of the patient's defect site, so that the brain tissue is not fully protected, and there are often dysfunctions caused by mismatch, and then provide a 3D printed Skull replacement device and method of making same.
本发明的技术方案是：它包括固定片、密质层一、密质层二和过渡层，固定片与密质层一由上至下依次位于过渡层的上方，密质层二位于过渡层下方且密质层一与密质层二通过过渡层连接，密质层一、过渡层和密质层二与缺损头骨的形状相同，过渡层为微观桁架结构。The technical scheme of the present invention is: it comprises fixed sheet, dense layer 1, dense layer 2 and transition layer, fixed sheet and dense layer 1 are positioned at the top of transition layer successively from top to bottom, dense layer 2 is positioned at transition layer The lower part and dense layer 1 and dense layer 2 are connected by a transition layer. The shape of dense layer 1, transition layer and dense layer 2 is the same as that of the defective skull, and the transition layer is a microscopic truss structure.
本发明还提供了制造一种3D打印的头骨替代装置的方法，该方法包括以下步骤：The present invention also provides a method for manufacturing a 3D printed skull replacement device, the method comprising the following steps:
步骤一：对受损的头骨进行3D成像，从而确定头骨的几何尺寸及参数，得到需要替代头骨原始数据；Step 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data that needs to be replaced;
步骤二：设计头盖骨替代结构的三维模型，打印设计模型；Step 2: Design a 3D model of the skull replacement structure and print the design model;
将影像中的头骨资料转换成立体模型，设计出解剖形状、结构以及力学性能与缺损头骨完全匹配的模型，导入3D打印计算机程序中，利用快速成型设备，将打印材料进行逐层堆积粘结，按照由下至上依次为密质层二、过渡层、密质层一、固定片的顺序叠加成型，固定片的外沿大于密质层一的外沿，用于开设多个螺纹孔；Convert the skull data in the image into a three-dimensional model, design a model that completely matches the anatomical shape, structure and mechanical properties of the defective skull, import it into a 3D printing computer program, and use rapid prototyping equipment to build up and bond the printed materials layer by layer. According to the order of dense layer 2, transition layer, dense layer 1, and fixed sheet from bottom to top, the outer edge of the fixed sheet is larger than the outer edge of dense layer 1, and is used to open multiple threaded holes;
步骤三：向密质层一、密质层二和过渡层的表面进行表面改性，至此，完成对头骨替代装置的3D打印。Step 3: Perform surface modification on the surface of the dense layer 1, the dense layer 2, and the transition layer. So far, the 3D printing of the skull replacement device is completed.
本发明与现有技术相比具有以下效果：Compared with the prior art, the present invention has the following effects:
方法优势：Method advantages:
1、制备快速，可以在3-5h内成型，成型时间较其他的制备方法短。1. The preparation is fast, and it can be molded within 3-5 hours, and the molding time is shorter than other preparation methods.
2、能够成型与病人缺损头骨形状和力学性能相匹配的替代物。2. It is possible to form a substitute that matches the shape and mechanical properties of the patient's defective skull.
3、此方法可以制作任意形状的替代物，制作出的替代物具有较强的适用性，可以替代人头盖骨的任意部位，适应于任意形状和大小的头骨损伤，可以适用于较大范围的人群。3. This method can produce substitutes of any shape. The produced substitutes have strong applicability and can replace any part of the human skull. It is suitable for skull injuries of any shape and size, and can be applied to a wide range of people. .
4、在此微观点阵结构的表面沉积羟基磷灰石，工艺简单，成本低，涂层厚度及形貌可控。4. Hydroxyapatite is deposited on the surface of the micro-array structure, the process is simple, the cost is low, and the thickness and shape of the coating are controllable.
装置优势：Device advantages:
1、替代材料与头骨的弹性模量一致，避免了替代材料在应力作用下与头骨产生不同的应变，从而在金属与骨的接触界面处出现相对位移，造成界面处的松动，影响植入器件的功能；或是造成应力屏蔽，引起骨组织的功能退化或吸收。1. The elastic modulus of the replacement material is consistent with that of the skull, which avoids the different strains of the replacement material and the skull under the action of stress, resulting in relative displacement at the contact interface between the metal and the bone, resulting in loosening of the interface and affecting the implanted device function; or cause stress shielding, causing functional degradation or absorption of bone tissue.
2、该类植入物带有可供骨头长入的孔隙，本发明的微观桁架结构层为相邻骨头在生长的过程中会进入孔隙，使真骨与假骨之间结成一体。2. This type of implant has pores for bone to grow into. The microscopic truss structure layer of the present invention allows adjacent bones to enter the pores during the growth process, so that the real bone and the false bone are integrated.
3、羟基磷灰石涂层与骨骼有相似的结构和成分，具有良好的生物相容性和活性。金属基体表面沉积的羟基磷灰石涂层，既保留了金属基体的力学性能，又兼顾了涂层的相容性和生物活性。有利于组织细胞的附着生长，促进骨整合。3. The hydroxyapatite coating has a similar structure and composition to bone, and has good biocompatibility and activity. The hydroxyapatite coating deposited on the surface of the metal substrate not only retains the mechanical properties of the metal substrate, but also takes into account the compatibility and biological activity of the coating. It is conducive to the attachment and growth of tissue cells and promotes osseointegration.
附图说明Description of drawings
图1是采用本发明的方法待制造的受损头骨结构示意图；图2是本发明的结构示意图；图3是图2的仰视图；图4是图2在A处的放大图。Fig. 1 is a schematic diagram of the damaged skull structure to be manufactured by the method of the present invention; Fig. 2 is a schematic diagram of the structure of the present invention; Fig. 3 is a bottom view of Fig. 2; Fig. 4 is an enlarged view of Fig. 2 at A.
具体实施方式Detailed ways
具体实施方式一：结合图1至图4说明本实施方式，本实施方式的一种3D打印的头骨替代装置，包括固定片4、密质层一1、密质层二2和过渡层3，固定片4与密质层一1由上至下依次位于过渡层3的上方，密质层二2位于过渡层3下方且密质层一1与密质层二2通过过渡层3连接，密质层一1、过渡层3和密质层二2与缺损头骨的形状相同，过渡层3为微观桁架结构。Specific Embodiment 1: This embodiment is described with reference to FIGS. 1 to 4 . A 3D printed skull replacement device in this embodiment includes a fixation piece 4 , a dense layer 1 , a dense layer 2 , and a transition layer 3 . The fixed sheet 4 and the compact layer 1 are located above the transition layer 3 from top to bottom, the compact layer 2 is located below the transition layer 3 and the compact layer 1 and the compact layer 2 are connected through the transition layer 3, and the compact layer 2 is located below the transition layer 3. Strain layer 1, transition layer 3, and compact layer 2 2 have the same shape as the defective skull, and transition layer 3 is a microscopic truss structure.
本实施方式在使用时与头骨之间的连接是通过多个螺栓安装在固定片4的外周的，以此来实现头骨与本实施方式之间的连接。The connection between the present embodiment and the skull during use is installed on the outer periphery of the fixing piece 4 through a plurality of bolts, so as to realize the connection between the skull and the present embodiment.
具体实施方式二：结合图2至图4说明本实施方式，本实施方式它还包括活性涂层5，活性涂层5沉积于密质层一1、密质层二2和过渡层3的外表面上。如此设置，既保留了金属基体的力学性能，又兼顾了涂层的相容性和生物活性其它组成和连接关系与具体实施方式一相同。Specific embodiment two: this embodiment is described in conjunction with Fig. 2 to Fig. 4, and present embodiment it also comprises active coating 5, and active coating 5 is deposited on the outside of tight layer one 1, dense layer two 2 and transition layer 3 On the surface. Such setting not only preserves the mechanical properties of the metal matrix, but also takes into account the compatibility and biological activity of the coating. The other composition and connection relationship are the same as those in the first embodiment.
具体实施方式三：结合图2说明本实施方式，本实施方式的活性涂层5为羟基磷灰石涂层。如此设置，有利于组织细胞的附着生长，促进骨整合。其它组成和连接关系与具体实施方式二相同。Specific Embodiment 3: This embodiment is described with reference to FIG. 2 . The active coating 5 of this embodiment is a hydroxyapatite coating. Such setting is conducive to the attachment and growth of tissue cells and promotes osseointegration. Other compositions and connections are the same as those in the second embodiment.
具体实施方式四：结合图2说明本实施方式，本实施方式的活性涂层5的厚度为30-50μm。如此设置，可以诱导骨组织迅速向其生长使种植体与周围骨组织形成化学键结合。其它组成和连接关系与具体实施方式二或三相同。Specific Embodiment 4: This embodiment is described with reference to FIG. 2 . The thickness of the active coating 5 in this embodiment is 30-50 μm. Such setting can induce bone tissue to rapidly grow toward it so that the implant and the surrounding bone tissue form chemical bonds. Other compositions and connections are the same as those in Embodiment 2 or 3.
具体实施方式五：结合图2至图3说明本实施方式，本实施方式的固定片4的外沿设有多个螺纹孔6。如此设置，便于与人体其他骨头连接。其它组成和连接关系与具体实施方式四相同。Embodiment 5: This embodiment is described with reference to FIG. 2 to FIG. 3 . In this embodiment, a plurality of threaded holes 6 are provided on the outer edge of the fixing piece 4 . Such setting facilitates connection with other bones of the human body. Other compositions and connections are the same as in Embodiment 4.
具体实施方式六：结合图2至图4说明本实施方式，本实施方式的固定片4的面积大于头骨的面积，且固定片4为曲面固定片。如此设置，便于与其他骨头对接。其它组成和连接关系与具体实施方式五相同。Embodiment 6: This embodiment is described with reference to FIGS. 2 to 4 . The area of the fixing piece 4 in this embodiment is larger than that of the skull, and the fixing piece 4 is a curved surface fixing piece. Such setting facilitates docking with other bones. Other compositions and connections are the same as those in Embodiment 5.
具体实施方式七：结合图1至图4说明本实施方式，本实施方式的一种制造3D打印的头骨替代装置的方法，该方法包括以下步骤：Specific Embodiment 7: This embodiment is described in conjunction with Fig. 1 to Fig. 4, a method for manufacturing a 3D printed skull replacement device in this embodiment, the method includes the following steps:
步骤一：对受损的头骨进行3D成像，从而确定头骨的几何尺寸及参数，得到需要替代头骨原始数据；Step 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data that needs to be replaced;
步骤二：设计头盖骨替代结构的三维模型，打印设计模型；Step 2: Design a 3D model of the skull replacement structure and print the design model;
将影像中的头骨资料转换成立体模型，设计出解剖形状、结构以及力学性能与缺损头骨完全匹配的模型，导入3D打印计算机程序中，利用快速成型设备，将打印材料进行逐层堆积粘结，按照由下至上依次为密质层二2、过渡层3、密质层一1、固定片4的顺序叠加成型，固定片4的外沿大于密质层一1的外沿，用于开设多个螺纹孔6；Convert the skull data in the image into a three-dimensional model, design a model that completely matches the anatomical shape, structure and mechanical properties of the defective skull, import it into a 3D printing computer program, and use rapid prototyping equipment to build up and bond the printed materials layer by layer. According to the order of dense layer 2 2, transition layer 3, dense layer 1, and fixed sheet 4 from bottom to top, the outer edge of fixed sheet 4 is larger than the outer edge of dense layer 1, and is used to set up multiple layers. 6 threaded holes;
步骤三：向密质层一1与密质层二2和过渡层3的表面进行表面改性，至此，完成对头骨替代装置的3D打印。Step 3: Carry out surface modification to the surfaces of dense layer 1, dense layer 2 2, and transition layer 3. So far, the 3D printing of the skull replacement device is completed.
表面改性(在试样表面沉积一层仿生层——羟基磷灰石)：Surface modification (deposition of a biomimetic layer - hydroxyapatite on the surface of the sample):
(1)在氩气气氛中，50℃温度下，用37％HCl溶液中浸泡90min；再在40℃下浸泡60min。(1) In an argon atmosphere, soak in 37% HCl solution for 90 minutes at 50°C; then soak for 60 minutes at 40°C.
(2)蒸馏水超声波清洗去除表面氧化物，清洗温度为40℃，清洗时间50min(2) Ultrasonic cleaning with distilled water to remove surface oxides, the cleaning temperature is 40°C, and the cleaning time is 50 minutes
(3)在10mol/L的NaOH溶液浸泡24h，温度控制在60℃，(3) Soak in 10mol/L NaOH solution for 24h, the temperature is controlled at 60°C,
(4)用蒸馏水清洗试样，在100℃下干燥。(4) The sample was washed with distilled water and dried at 100°C.
试样干燥后浸入SBF溶液中，37℃水浴保温，每隔2d更换一次溶液，浸泡培养21d后取出，用蒸馏水清洗并在烘箱中干燥。After drying, the samples were immersed in SBF solution, kept at 37°C in a water bath, and the solution was replaced every 2 days. After soaking and culturing for 21 days, they were taken out, washed with distilled water and dried in an oven.
装置表面生成羟基磷灰石涂层的方法不仅限于上述方法，可以是溶胶凝胶法，微弧氧化法等。表面改性不仅限于羟基磷灰石涂层，可以是其他涂层。The method for forming the hydroxyapatite coating on the surface of the device is not limited to the above-mentioned methods, and may be a sol-gel method, a micro-arc oxidation method, and the like. Surface modification is not limited to hydroxyapatite coatings but can be other coatings.
打印过程：Printing process:
采用德国EOS公司的金属3D打印机M270，使用过程中的参数为：Using the metal 3D printer M270 of German EOS company, the parameters during use are:
工艺参数：激光功率170W，扫描速度为1250mm/s，光斑大小为100μm，氧含量<0.1，层厚为30μm，扫描间距为60μmProcess parameters: laser power 170W, scanning speed 1250mm/s, spot size 100μm, oxygen content <0.1, layer thickness 30μm, scanning distance 60μm
加工出的样品后处理：在氩保护气氛中循环热处理以释放热应力(680℃高温下热处理4h,然后冷却)；用异丙醇对样品表面进行超声清洗，然后用双蒸馏水清洗并在空气中晾干。Post-treatment of the processed sample: cyclic heat treatment in an argon protective atmosphere to release thermal stress (heat treatment at 680°C for 4 hours, then cooling); ultrasonically clean the surface of the sample with isopropanol, then clean it with double distilled water and dry it in air to dry.
具体实施方式八：结合图1至图4说明本实施方式，本实施方式的步骤二中的打印材料为钛合金粉末、金属粉末、陶瓷粉末，塑料和细胞组织。如此设置，可以具有良好的生物相容性，且具有良好的力学性能。其它组成和连接关系与具体实施方式七相同。Embodiment 8: This embodiment is described with reference to FIG. 1 to FIG. 4 . The printing materials in Step 2 of this embodiment are titanium alloy powder, metal powder, ceramic powder, plastic and cell tissue. Such setting can have good biocompatibility and good mechanical properties. Other compositions and connections are the same as those in Embodiment 7.
具体实施方式九：结合图1至图4说明本实施方式，本实施方式的步骤二中的过渡层3为微观点阵桁架结构层。在实际使用过程中，可选用金字塔结构、镂空多面体结构、极小曲面结构等其他微观结构，如此设置，便于相邻骨头在生长的过程中会进入孔隙，使真骨与假骨之间结成一体，患者骨骼能尽快康复。其它组成和连接关系与具体实施方式八相同。Ninth specific embodiment: This embodiment will be described with reference to FIG. 1 to FIG. 4 . The transition layer 3 in step 2 of this embodiment is a micro-array truss structure layer. In the actual use process, other microstructures such as pyramid structure, hollow polyhedron structure, and extremely small curved surface structure can be used, so that the adjacent bones will enter the pores during the growth process, so that the real bone and the false bone will form. One body, the patient's bones can recover as soon as possible. Other compositions and connections are the same as those in Embodiment 8.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510566870.XACN105105872A (en) | 2015-09-08 | 2015-09-08 | Skull replacing apparatus of 3D print and manufacturing method thereof |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510566870.XACN105105872A (en) | 2015-09-08 | 2015-09-08 | Skull replacing apparatus of 3D print and manufacturing method thereof |
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| CN105105872Atrue CN105105872A (en) | 2015-12-02 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201510566870.XAPendingCN105105872A (en) | 2015-09-08 | 2015-09-08 | Skull replacing apparatus of 3D print and manufacturing method thereof |
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| CN (1) | CN105105872A (en) |
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