医用碳/碳复合材料表面改性及其生物医学应用研究
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摘要
碳/碳复合材料是材料领域中重点发展的一种新型材料，作为医用植入物的研究已经有30多年的历史了，生物相容性较好、力学参数与人骨接近，有良好的应用前景，但是到目前为止还没有真正在临床中应用。本文围绕碳/碳复合材料应用中的基本问题，着重研究了医用碳/碳复合材料的制备及生物相容性、表面改性、耐磨性能提高、个体化人工骨制备以及在放射治疗中对剂量的影响。
本文针对碳/碳复合材料杂质甚至有毒元素含量偏高的现状，提出了延长高温（2800～3200℃）石墨化处理时间以降低碳/碳复合材料杂质（有毒元素）含量，按照中华人民共和国国家医疗器械标准要求，对其进行生物安全性研究，认为经过12h高温处理后，碳/碳复合材料是符合国家医疗器械生物安全标准要求的。研究了不同工艺制备的碳/碳复合材料对成骨细胞生长的影响，对影响细胞生长的因素进行了分析；同时也研究了成骨细胞在碳/碳复合材料表面的粘附特性，对其粘附机制进行了探讨和解释。
通过梯度化学气相沉积法（CVD）改变医用碳/碳复合材料表面热解碳的结构分布来提高摩擦性能，得到了梯度CVD法制备医用碳/碳复合材料涂层的工艺流程，解决了医用碳/碳复合材料易磨损的问题，同时借助扫描电镜（SEM）、X射线衍射（XRD）、摩擦实验机等测试手段分析了梯度CVD法制备的医用碳/碳复合材料涂层耐摩擦的机制。
在等离子喷涂的基础上，发展了一种制备羟基磷灰石涂层的新工艺—用等离子体预处理碳/碳复合材料，再进行等离子喷涂，涂层的结合强度得到改善。借助扫描电镜（SEM）、X射线衍射（XRD）、红外光谱（FT-IR）、划痕仪等分析手段，探讨等离子体预处理碳/碳复合材料等离子喷涂涂层的形成机理，发现在等离子体预处理后，碳/碳复合材料表面出现活性基团，亦可去除碳纤维周围热解碳表面的缺陷并形成刻蚀凹坑，这些因素有利于提高涂层的结合强度。
对碳/碳复合材料表面等离子喷涂羟基磷灰石涂层进行体内外生物学性能研究，羟基磷灰石涂层能在体内和体外诱导沉积出新的类骨磷灰石涂层，并可进一步诱导新生骨组织的形成。在体外，成骨细胞在涂层表面生长良好。动物实验证明，羟基磷灰石涂层能诱导新生骨组织的快速生长，同时借助扫描电镜（SEM）和病理切片对涂层界面处骨组织的修复进行了系统的研究。通过血常规、生化指标等检查分析，发现羟基磷灰石涂层和碳/碳复合材料生物安全性好。
对碳/碳复合材料植入物在放射治疗的应用前景进行了研究，与金属植入物相比，碳/碳复合材料植入物在放射治疗各个步骤中都有不可比拟的优势，借助蒙特卡罗方法详细分析了植入物对射线入射面和出射面的剂量影响及在实际计划设计中植入物对剂量的影响,得到使用碳/碳复合材料植入物不会引起射线入射面剂量增加，也不会引起射线出射面剂量急剧减少的结论。对吸收了一定放射治疗剂量的碳/碳复合材料植入物进行力学性能测试，认为放射治疗的剂量不会对碳/碳复合材料力学性能产生影响，适合做需要放射治疗植入物的材料。
发展了一种快速制备个体化碳/碳复合材料人工骨的新方法，该方法把DICOM格式的骨骼模型转换为机械加工软件可识别的非均匀有理B样条格式，借助手术效果可视化评估的新方法指导人工骨的轮廓的勾画，通过数控加工中心加工出个体化碳/碳复合材料人工骨。
Carbon/carbon composites is a developed material in material science. It has been studied for30yearsas a medical implant. With good biological compatibility, chemical stability, good mechanicalproperties and elastic modulus similar to human bones, carbon/carbon composites have good prospectfor application. But so far, they have not being actually clinically used. This dissertation mainlystudies carbon/carbon composites preparation, biological compatibility, surface modification，theimprovement of wear resistance，the preparation of individual artificial bone and the effect on thedosage in radiotherapy.
In this dissertation, according to the present situation that carbon/carbon composites has shortcomingsfor the use in the field of medicine such as the impurities or even high content of toxic elements, wepropose that the high temperature (2800-3200℃) processing time be extended to reducecarbon/carbon composite material impurity (toxicity) content. Research on biological safety has beencarried out according to the National Standards for Medical Equipment of the People's Republic ofChina. We believe that the carbon/carbon composite material which is processed at2800-3200℃for12h is in line with the national standards of medical devices. We studied the effects on osteoblastgrowth with carbon/carbon composite by different preparation processes, and analyzed the cell growthfactors.We also studied adhesion characteristics of osteoblastic cells on carbon/carbon compositesurface, discussed and explained adhesion mechanism.
Pyrolytic carbon structure distribution of medical carbon/carbon composites surface modified bygradient chemical vapor deposition（CVD）can improve the surface wear resistance and obtain thetechniques for preparing medical carbon/carbon composite coating by gradient CVD was obtained.This technique can solve the problem of easy abrasion of medical carbon/carbon composite. Also themechanism of friction resistance by gradient CVD was explored by scanning electron microscope(SEM), X ray diffraction (XRD), friction test machine.
A novel technology of plasma pre-treatment was developed for preparation of hydroxyapatite coatingon carbon/carbon composite by plasma spraying.This technique provides improved adhesive coating.By scanning electron microscope (SEM), X ray diffraction (XRD), infrared spectroscopy(FT-IR) and scratch test analysis, we found active groups and pyrolytic carbon defects removed oncarbon/carbon composite surface after plasma pretreatment. These factors are beneficial for theimprovement of the bond strength of the coatings.
The research of biological properties was carried out in vivo and in vitro. New apatite layer can bedeposited on the hydroxyapatite coatings in vivo and in vitro. These new apatite coating can inducenew bone formation. In vitro, the growth of osteoblasts on the surface of the coating is good. Animalexperiment proved that hydroxyapatite coatings can induce the rapid growth of new bone tissue.At thesame time, systematic research has been done about the bone tissue repair at the interface of coatingusing scanning electron microscope (SEM) and pathological sections. From the routine bloodexamination and biochemical examination analysis, we found that hydroxyapatite coating andcarbon/carbon composite material have good biological safety
We studied the prospect of the carbon/carbon composite implants in radiation therapy. Compared withmetal implants, the carbon/carbon composite implants have incomparable superiority in radiotherapyfor the treatment of various steps. With Monte Carlo simulation, we analyzed in detail the incidentsurface dose and the exit surface dose of implant. We also study the dose effect of implants in theactual plan design. The mechanical properties of carbon/carbon composite implants after absorbingdifferent radiation therapy dose were tested.That radiation therapy dose does not have impact onmechanical properties of carbon/carbon composites.Therefore, they are more suitable to patients inneed of radiotherapy.It is found that carbon plates will neither increase the incident surface dose, norlead to the sharp decrease of exit surface dose (the effect of a second build-up). Carbon fiberorthopedic implants have a good prospect for radiotherapy patients because they have minimalperturbation effects on the radiotherapy dose distribution.
Finally, a novel method that can rapidly prepare individual artificial bone of carbon/carbon compositewas developed.The DICOM format of the skeletal model is converted to non-uniform rational B-spineformat that can be identified by mechanical processing software. Individual artificial bone contourwas sketched with the help of visual operation effect. Individual artificial bone of carbon/carboncomposite was prepared through the CNC Machining Center.
本文针对碳/碳复合材料杂质甚至有毒元素含量偏高的现状，提出了延长高温（2800～3200℃）石墨化处理时间以降低碳/碳复合材料杂质（有毒元素）含量，按照中华人民共和国国家医疗器械标准要求，对其进行生物安全性研究，认为经过12h高温处理后，碳/碳复合材料是符合国家医疗器械生物安全标准要求的。研究了不同工艺制备的碳/碳复合材料对成骨细胞生长的影响，对影响细胞生长的因素进行了分析；同时也研究了成骨细胞在碳/碳复合材料表面的粘附特性，对其粘附机制进行了探讨和解释。
通过梯度化学气相沉积法（CVD）改变医用碳/碳复合材料表面热解碳的结构分布来提高摩擦性能，得到了梯度CVD法制备医用碳/碳复合材料涂层的工艺流程，解决了医用碳/碳复合材料易磨损的问题，同时借助扫描电镜（SEM）、X射线衍射（XRD）、摩擦实验机等测试手段分析了梯度CVD法制备的医用碳/碳复合材料涂层耐摩擦的机制。
在等离子喷涂的基础上，发展了一种制备羟基磷灰石涂层的新工艺—用等离子体预处理碳/碳复合材料，再进行等离子喷涂，涂层的结合强度得到改善。借助扫描电镜（SEM）、X射线衍射（XRD）、红外光谱（FT-IR）、划痕仪等分析手段，探讨等离子体预处理碳/碳复合材料等离子喷涂涂层的形成机理，发现在等离子体预处理后，碳/碳复合材料表面出现活性基团，亦可去除碳纤维周围热解碳表面的缺陷并形成刻蚀凹坑，这些因素有利于提高涂层的结合强度。
对碳/碳复合材料表面等离子喷涂羟基磷灰石涂层进行体内外生物学性能研究，羟基磷灰石涂层能在体内和体外诱导沉积出新的类骨磷灰石涂层，并可进一步诱导新生骨组织的形成。在体外，成骨细胞在涂层表面生长良好。动物实验证明，羟基磷灰石涂层能诱导新生骨组织的快速生长，同时借助扫描电镜（SEM）和病理切片对涂层界面处骨组织的修复进行了系统的研究。通过血常规、生化指标等检查分析，发现羟基磷灰石涂层和碳/碳复合材料生物安全性好。
对碳/碳复合材料植入物在放射治疗的应用前景进行了研究，与金属植入物相比，碳/碳复合材料植入物在放射治疗各个步骤中都有不可比拟的优势，借助蒙特卡罗方法详细分析了植入物对射线入射面和出射面的剂量影响及在实际计划设计中植入物对剂量的影响,得到使用碳/碳复合材料植入物不会引起射线入射面剂量增加，也不会引起射线出射面剂量急剧减少的结论。对吸收了一定放射治疗剂量的碳/碳复合材料植入物进行力学性能测试，认为放射治疗的剂量不会对碳/碳复合材料力学性能产生影响，适合做需要放射治疗植入物的材料。
发展了一种快速制备个体化碳/碳复合材料人工骨的新方法，该方法把DICOM格式的骨骼模型转换为机械加工软件可识别的非均匀有理B样条格式，借助手术效果可视化评估的新方法指导人工骨的轮廓的勾画，通过数控加工中心加工出个体化碳/碳复合材料人工骨。
Carbon/carbon composites is a developed material in material science. It has been studied for30yearsas a medical implant. With good biological compatibility, chemical stability, good mechanicalproperties and elastic modulus similar to human bones, carbon/carbon composites have good prospectfor application. But so far, they have not being actually clinically used. This dissertation mainlystudies carbon/carbon composites preparation, biological compatibility, surface modification，theimprovement of wear resistance，the preparation of individual artificial bone and the effect on thedosage in radiotherapy.
In this dissertation, according to the present situation that carbon/carbon composites has shortcomingsfor the use in the field of medicine such as the impurities or even high content of toxic elements, wepropose that the high temperature (2800-3200℃) processing time be extended to reducecarbon/carbon composite material impurity (toxicity) content. Research on biological safety has beencarried out according to the National Standards for Medical Equipment of the People's Republic ofChina. We believe that the carbon/carbon composite material which is processed at2800-3200℃for12h is in line with the national standards of medical devices. We studied the effects on osteoblastgrowth with carbon/carbon composite by different preparation processes, and analyzed the cell growthfactors.We also studied adhesion characteristics of osteoblastic cells on carbon/carbon compositesurface, discussed and explained adhesion mechanism.
Pyrolytic carbon structure distribution of medical carbon/carbon composites surface modified bygradient chemical vapor deposition（CVD）can improve the surface wear resistance and obtain thetechniques for preparing medical carbon/carbon composite coating by gradient CVD was obtained.This technique can solve the problem of easy abrasion of medical carbon/carbon composite. Also themechanism of friction resistance by gradient CVD was explored by scanning electron microscope(SEM), X ray diffraction (XRD), friction test machine.
A novel technology of plasma pre-treatment was developed for preparation of hydroxyapatite coatingon carbon/carbon composite by plasma spraying.This technique provides improved adhesive coating.By scanning electron microscope (SEM), X ray diffraction (XRD), infrared spectroscopy(FT-IR) and scratch test analysis, we found active groups and pyrolytic carbon defects removed oncarbon/carbon composite surface after plasma pretreatment. These factors are beneficial for theimprovement of the bond strength of the coatings.
The research of biological properties was carried out in vivo and in vitro. New apatite layer can bedeposited on the hydroxyapatite coatings in vivo and in vitro. These new apatite coating can inducenew bone formation. In vitro, the growth of osteoblasts on the surface of the coating is good. Animalexperiment proved that hydroxyapatite coatings can induce the rapid growth of new bone tissue.At thesame time, systematic research has been done about the bone tissue repair at the interface of coatingusing scanning electron microscope (SEM) and pathological sections. From the routine bloodexamination and biochemical examination analysis, we found that hydroxyapatite coating andcarbon/carbon composite material have good biological safety
We studied the prospect of the carbon/carbon composite implants in radiation therapy. Compared withmetal implants, the carbon/carbon composite implants have incomparable superiority in radiotherapyfor the treatment of various steps. With Monte Carlo simulation, we analyzed in detail the incidentsurface dose and the exit surface dose of implant. We also study the dose effect of implants in theactual plan design. The mechanical properties of carbon/carbon composite implants after absorbingdifferent radiation therapy dose were tested.That radiation therapy dose does not have impact onmechanical properties of carbon/carbon composites.Therefore, they are more suitable to patients inneed of radiotherapy.It is found that carbon plates will neither increase the incident surface dose, norlead to the sharp decrease of exit surface dose (the effect of a second build-up). Carbon fiberorthopedic implants have a good prospect for radiotherapy patients because they have minimalperturbation effects on the radiotherapy dose distribution.
Finally, a novel method that can rapidly prepare individual artificial bone of carbon/carbon compositewas developed.The DICOM format of the skeletal model is converted to non-uniform rational B-spineformat that can be identified by mechanical processing software. Individual artificial bone contourwas sketched with the help of visual operation effect. Individual artificial bone of carbon/carboncomposite was prepared through the CNC Machining Center.
引文
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