编织结构生物可降解神经再生导管的制造及性能研究
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摘要
周围神经缺损后的再生和功能恢复一直是神经科学领域的热门问题。由于周围神经结构和功能上的特殊性，其再生能力较差，大多数神经缺损无法采用直接端端吻合方法修复。自体神经移植是目前用于修复周围神经缺损的最常用、最有效的方法。然而，自体神经移植必然伴随着供区的功能受损，且可供移植的神经来源有限。异体神经移植虽然来源充足、各种类型的神经段都可以得到，但存在着较强的免疫排斥反应。因此，人们一直在探寻一种更为理想的方法来取代自体神经移植。
近年来，由医学、生物学、材料学和工程学等综合而成的组织工程学发展迅速，人们研究的重点已着眼于使用神经导管代替自体神经移植来促进神经再生，以达到神经快速生长、功能完全恢复的理想目标。
通过对生物材料的筛选和评价，本文采用生物可降解材料聚乙丙交酯(PGLA)长丝在二维锭子式编织机上织造出管状编织物，再经壳聚糖浸泡涂层和热定型处理研制出具有一定机械强度和弹性的编织结构复合材料神经再生导管。该生物可降解神经再生导管具有良好的生物相容性和安全性。
在进行实际编织神经导管之前，首先对管状编织物的上机编织工艺进行实验研究和理论分析。为了获得形状稳定、表面均匀的导管，本文采用带芯编织方法。在现有型号编织机的实验条件下，通过改变携纱器的安装方法和从角齿轮螺栓中心的通孔引入轴纱，神经导管的编织选用菱形结构、规则结构和三向结构等三种组织结构。除了组织结构，编织角也是影响神经导管性能的一个重要结构参数。在带芯编织的条件下，最终制得的神经导管的编织角近似地等于编织过程中的编织工艺角。在编织过程中，编织工艺角是通过改变编织机上变化齿轮的齿数使牵引轮的牵拉速度与携纱器的转动速度相匹配来进行控制的。然而，编织工艺角的最大值和最小值分别是由携纱器有效的纱线储藏量、编织机的尺寸决定的。
采用侧向压缩方式，在专门制造的径向压缩仪上对编织结构神经导管进行径向压缩试验，以考察编织结构神经导管的径向压缩特性，分析组织结构、编织角等结构参数对编织结构神经导管的径向压缩性能以及因压缩引起的神经导管使用性能(横截面积)变化的影响。采用改进的夹持装置夹持试样对编织结构神经导管进行轴向拉伸试验，以考察编织结构神经导管的轴向拉伸特性，分析组织结构和编织角等结构参数对编织结构神经导管的轴向拉伸性能以及在初始很小拉伸力作用下神经导管使用性能(长度、横截面积和纱线覆盖率)变化的影响。通过试验与分析，作者发现改进组织结构和优化结构参数可以提高编织结构神经导管的径向抗压能力和轴向抗拉能力，以更好地满足桥接周围神经缺损的性能要求。
对编织结构神经导管进行体外模拟降解试验，以探讨编织结构神经导管的径向压缩性能、质量损耗以及形貌在降解过程中的变化规律，分析原料组分配比、组织结构和涂层处理等制造工艺参数对神经导管性能在降解过程中变化的影响。采用壳聚糖涂层并预置入引导纤维的三向结构神经导管分别桥接大鼠坐骨神经缺损和犬胫神经缺损的动物实验表明，该神经导管具有良好的生物相容性和安全性，可以有效地桥接周围神经缺损。
本课题的研究工作对优化编织结构神经导管的选材、制造工艺，探讨结构参数与神经导管性能之间的关系以及神经导管性能在体外降解过程中的变化规律等方面进行了有益的尝试，为进一步改进和优化编织结构神经导管的结构与性能提供了一定的依据。同时，也将会促进和推动生物医用纺织品的进一步发展。
Peripheral nerve defects continue to be one of the most challenging problems to surgeons. The ability to regeneration of peripheral nerve is very poor because of its unique structure and function, thus most of the peripheral nerve defects are not permit to repair by direct tensionless suture. In such situation, grafting with a segment of autologous nerve is a usual and effective clinical practice, but has drawbacks such as donor site morbidity, and incomplete recovery of function. In addition, grafting with allograft nerves has strong immunological rejection in spite of their abundant source. With the development of tissue engineering, recent approaches have been developed in which a nerve regeneration conduit may be used to replace the need for nerve grafting. Thanks to the use of artificial nerve regeneration conduits, much progress has been made in the repairs of peripheral nerve defects.
After selection and evaluation of the constituent biological materials, a tubular braid was fabricated from biodegradable poly (glycolide-co-L-lactide) (PGLA) on a conventional 2-D tubular braiding machine. The braided composite nerve regeneration conduits with adequate mechanical strength and elasticity were made by coating and heat setting methods. This biodegradable braided nerve regeneration conduit possesses excellent biocompatibility and bioactive properties.
Before braiding the nerve conduits, the author investigated the braiding process of tubular braids by experimental work and theoretical analysis. In order to prevent the tubular braids from being flattened due to taking-up operation and to get desired inner diameter, a cylindrical metal mandrel was adopted during braiding. Three kinds of braided structures, diamond, regular and triaixal were used by adjusting the arrangement of carriers and introducing the axial yarns through stationary guide eyes. Besides the braided structure, the braiding angle is another important geometric parameter of tubular braids. In the case of braiding with a cylindrical mandrel, the braiding process angle is considered approximately as the braiding angle of tubular braids. The braiding process angle is controlled by changing the teeth number of gear which accomplishes the matching of the velocities of both the traction wheel and the carriers. However, the maximum and minimum values of the braiding process angles were determined respectively by the effective yarn reserve of carriers and the dimension of braiding machine.
The radial compressive tests of lateral compression of braided conduits were carried out on custom-built compression device to examine their radial compressive behaviors. The effects of braided structure and braiding angle on the compressive properties and the change of cross-sectional area of braided conduits caused by radial compression are analyzed. The axial tensile tests of braided conduits were carried out by clamping the samples with modified clamping device to examine their axial tensile behaviors. The effects of braided structure and braiding angle on the tensile properties and the changes of length, cross-sectional area and yarn cover factor of braided conduits caused by primary small axial tension are analyzed. The author finds that changing braiding structure and optimizing structure parameters can raise the radial compressive and axial tensional resistances to meet the requirements for the repair of peripheral nerve defects.
Basic information about the changes of radial compressive property, mass loss and appearance of braided conduits were obtained through simulation in vitro degradation tests. The effects of the composition of polymeric materials, braided structure and coating on the changes of the properties of braided conduits during the degradation were analyzed. The animal tests were made by repairing rat sciatic nerve defects and dog tibial nerve defects with triaixal braided nerve conduit coated with chitosan and filled with a guide-fiber. The testing results have show that triaixal braided PGLA conduits coated with chitosan and filled with a guide-fiber offer a possible substitute for the repair of peripheral nerve defects.
Achievements obtained from this research work could be used as a valuable reference which provides a certain foundation for the investigation of braided biodegradable nerve regeneration conduits and promote the development of textile products used in medical field.
近年来，由医学、生物学、材料学和工程学等综合而成的组织工程学发展迅速，人们研究的重点已着眼于使用神经导管代替自体神经移植来促进神经再生，以达到神经快速生长、功能完全恢复的理想目标。
通过对生物材料的筛选和评价，本文采用生物可降解材料聚乙丙交酯(PGLA)长丝在二维锭子式编织机上织造出管状编织物，再经壳聚糖浸泡涂层和热定型处理研制出具有一定机械强度和弹性的编织结构复合材料神经再生导管。该生物可降解神经再生导管具有良好的生物相容性和安全性。
在进行实际编织神经导管之前，首先对管状编织物的上机编织工艺进行实验研究和理论分析。为了获得形状稳定、表面均匀的导管，本文采用带芯编织方法。在现有型号编织机的实验条件下，通过改变携纱器的安装方法和从角齿轮螺栓中心的通孔引入轴纱，神经导管的编织选用菱形结构、规则结构和三向结构等三种组织结构。除了组织结构，编织角也是影响神经导管性能的一个重要结构参数。在带芯编织的条件下，最终制得的神经导管的编织角近似地等于编织过程中的编织工艺角。在编织过程中，编织工艺角是通过改变编织机上变化齿轮的齿数使牵引轮的牵拉速度与携纱器的转动速度相匹配来进行控制的。然而，编织工艺角的最大值和最小值分别是由携纱器有效的纱线储藏量、编织机的尺寸决定的。
采用侧向压缩方式，在专门制造的径向压缩仪上对编织结构神经导管进行径向压缩试验，以考察编织结构神经导管的径向压缩特性，分析组织结构、编织角等结构参数对编织结构神经导管的径向压缩性能以及因压缩引起的神经导管使用性能(横截面积)变化的影响。采用改进的夹持装置夹持试样对编织结构神经导管进行轴向拉伸试验，以考察编织结构神经导管的轴向拉伸特性，分析组织结构和编织角等结构参数对编织结构神经导管的轴向拉伸性能以及在初始很小拉伸力作用下神经导管使用性能(长度、横截面积和纱线覆盖率)变化的影响。通过试验与分析，作者发现改进组织结构和优化结构参数可以提高编织结构神经导管的径向抗压能力和轴向抗拉能力，以更好地满足桥接周围神经缺损的性能要求。
对编织结构神经导管进行体外模拟降解试验，以探讨编织结构神经导管的径向压缩性能、质量损耗以及形貌在降解过程中的变化规律，分析原料组分配比、组织结构和涂层处理等制造工艺参数对神经导管性能在降解过程中变化的影响。采用壳聚糖涂层并预置入引导纤维的三向结构神经导管分别桥接大鼠坐骨神经缺损和犬胫神经缺损的动物实验表明，该神经导管具有良好的生物相容性和安全性，可以有效地桥接周围神经缺损。
本课题的研究工作对优化编织结构神经导管的选材、制造工艺，探讨结构参数与神经导管性能之间的关系以及神经导管性能在体外降解过程中的变化规律等方面进行了有益的尝试，为进一步改进和优化编织结构神经导管的结构与性能提供了一定的依据。同时，也将会促进和推动生物医用纺织品的进一步发展。
Peripheral nerve defects continue to be one of the most challenging problems to surgeons. The ability to regeneration of peripheral nerve is very poor because of its unique structure and function, thus most of the peripheral nerve defects are not permit to repair by direct tensionless suture. In such situation, grafting with a segment of autologous nerve is a usual and effective clinical practice, but has drawbacks such as donor site morbidity, and incomplete recovery of function. In addition, grafting with allograft nerves has strong immunological rejection in spite of their abundant source. With the development of tissue engineering, recent approaches have been developed in which a nerve regeneration conduit may be used to replace the need for nerve grafting. Thanks to the use of artificial nerve regeneration conduits, much progress has been made in the repairs of peripheral nerve defects.
After selection and evaluation of the constituent biological materials, a tubular braid was fabricated from biodegradable poly (glycolide-co-L-lactide) (PGLA) on a conventional 2-D tubular braiding machine. The braided composite nerve regeneration conduits with adequate mechanical strength and elasticity were made by coating and heat setting methods. This biodegradable braided nerve regeneration conduit possesses excellent biocompatibility and bioactive properties.
Before braiding the nerve conduits, the author investigated the braiding process of tubular braids by experimental work and theoretical analysis. In order to prevent the tubular braids from being flattened due to taking-up operation and to get desired inner diameter, a cylindrical metal mandrel was adopted during braiding. Three kinds of braided structures, diamond, regular and triaixal were used by adjusting the arrangement of carriers and introducing the axial yarns through stationary guide eyes. Besides the braided structure, the braiding angle is another important geometric parameter of tubular braids. In the case of braiding with a cylindrical mandrel, the braiding process angle is considered approximately as the braiding angle of tubular braids. The braiding process angle is controlled by changing the teeth number of gear which accomplishes the matching of the velocities of both the traction wheel and the carriers. However, the maximum and minimum values of the braiding process angles were determined respectively by the effective yarn reserve of carriers and the dimension of braiding machine.
The radial compressive tests of lateral compression of braided conduits were carried out on custom-built compression device to examine their radial compressive behaviors. The effects of braided structure and braiding angle on the compressive properties and the change of cross-sectional area of braided conduits caused by radial compression are analyzed. The axial tensile tests of braided conduits were carried out by clamping the samples with modified clamping device to examine their axial tensile behaviors. The effects of braided structure and braiding angle on the tensile properties and the changes of length, cross-sectional area and yarn cover factor of braided conduits caused by primary small axial tension are analyzed. The author finds that changing braiding structure and optimizing structure parameters can raise the radial compressive and axial tensional resistances to meet the requirements for the repair of peripheral nerve defects.
Basic information about the changes of radial compressive property, mass loss and appearance of braided conduits were obtained through simulation in vitro degradation tests. The effects of the composition of polymeric materials, braided structure and coating on the changes of the properties of braided conduits during the degradation were analyzed. The animal tests were made by repairing rat sciatic nerve defects and dog tibial nerve defects with triaixal braided nerve conduit coated with chitosan and filled with a guide-fiber. The testing results have show that triaixal braided PGLA conduits coated with chitosan and filled with a guide-fiber offer a possible substitute for the repair of peripheral nerve defects.
Achievements obtained from this research work could be used as a valuable reference which provides a certain foundation for the investigation of braided biodegradable nerve regeneration conduits and promote the development of textile products used in medical field.
引文
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