CN112274699A - 小口径组织改良复合型人工血管 - Google Patents

小口径组织改良复合型人工血管 Download PDF

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CN112274699A
CN112274699A CN201910672525.2A CN201910672525A CN112274699A CN 112274699 A CN112274699 A CN 112274699A CN 201910672525 A CN201910672525 A CN 201910672525A CN 112274699 A CN112274699 A CN 112274699A
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tissue
blood vessel
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artificial blood
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史珂慧
王丽
刘华
何荃
王萌
孙凌霜
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First Affiliated Hospital of Medical College of Xian Jiaotong University
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Abstract

本发明公开了小口径组织改良复合型人工血管，包括外层组织、内层组织和胶联组织，所述的外层组织由混纺层、微米颗粒孔和主动脉弹力层组成，所述的内层组织由去细胞心内膜、内膜增生层和抗血栓药物层组成，所述的胶联组织由N‑羟基琥珀酰亚胺和碳二亚胺组成，首先通过微孔结构，达到利于血管内皮细胞增殖作用，其次通过天然脱细胞基质材料，从而具有很好顺应性和细胞相容性，能够促进细胞的黏附、增殖和分化、铺展，完成血管的再内皮化；外层为丝素蛋白、羧基化细菌纤维素和明胶的混纺层，增加血管的力学性能，有利于平滑肌等细胞的侵入；内层的内侧可以用不同的药物修饰，如药物肝素，提高人工血管抗血栓和促进血管内膜形成，最终利于血管的重建。

Description

小口径组织改良复合型人工血管
技术领域
本发明涉及复合型人工小血管，尤其涉及小口径组织改良复合型人工血管。
背景技术
随着患心血管疾病(Coronary artery disease，CAD)的人数不断上升，人工血管移植需求量逐年增加。在临床上，大口径血管已经得到了很好的应用，但使用相同的材料制得的小口径血管(直径<6mm)却容易发生血栓形成问题，其原因可能与移植物材料本身性能相关。自体血管被认为是临床上使用的金标准，但是自体血管采取对患者存在巨大创伤且可取的数量有限，因此找到与人体自身血管性能类似，生物相容性好并且其来源丰富的血管材料显得尤为重要。
脱细胞血管除去了异种细胞可有效地减少排异反应，同时保留了胞外基质，主要为胶原和弹性纤维，这些物质在哺乳动物中有很高的同源性，种属差异小，这种血管由于源于天然血管，所以具有很好的顺应性和细胞相容性，能够促进细胞的黏附、增殖和分化、铺展，完成血管的再内皮化。但是血管材料在经过脱细胞处理后，血管内壁的内皮细胞被去除，内膜下胶原暴露，可以激活凝血系统，因而如果将脱细胞血管直接用作替代材料植入体内，易引发血栓，其通畅率不高，而且经脱细胞处理后血管力学性能降低、弹力蛋白的降解加速等，从而导致动脉瘤的形成。鉴于此，有必要设计小口径组织改良复合型人工血管来解决上述问题。
发明内容
本发明所要解决的技术问题在于：提供小口径组织改良复合型人工血管，来解决目前人工血管抗血栓效果差，且无法达到很好力学性能的问题。
为解决上述技术问题，本发明的技术方案是：小口径组织改良复合型人工血管，包括外层组织、内层组织和胶联组织，所述的外层组织由混纺层、微米颗粒孔和主动脉弹力层组成，所述的内层组织由去细胞心内膜、内膜增生层和抗血栓药物层组成，所述的胶联组织由N-羟基琥珀酰亚胺和碳二亚胺组成，所述的内层组织通过胶联组织固设于外层组织内部，所述的微米颗粒孔数量为若干件，所述的微米颗粒孔均匀分布于混纺层内部，所述的主动脉弹力层复合于混纺层内侧，所述的内膜增生层固设于去细胞心内膜内侧，所述的抗血栓药物层固设于内膜增生层内侧。
进一步，所述的混纺层由羧基化细菌纤维素、明胶和丝素蛋白组成，所述的羧基化细菌纤维素、明胶和蚕丝蛋白的质量比为，羧基化细菌纤维素:明胶:蚕丝蛋白＝1:0.5:8.5。
进一步，所述的所述羧基化细菌纤维素的羧基含量大于20％，所述的羧基化细菌纤维素的羧基含量为20％-50％。
进一步，所述的丝素蛋白为蚕丝中提取的天然高分子纤维蛋白，所述的天然高分子纤维蛋白内含丝氨酸和苏氨酸。
进一步，所述的微米颗粒孔孔径为20～70μm，孔隙度为65％。
进一步，所述的主动脉弹力层由天然脱细胞基质材料、蚕丝丝素和蚕丝蛋白溶液组成，所述的然脱细胞基质材料、蚕丝丝素和蚕丝蛋白溶液的质量比为，天然脱细胞基质材料:蚕丝丝素:蚕丝蛋白溶液＝2.3:7:0.7。
进一步，所述的天然脱细胞基质材料是用胰酶脱细胞后，再用RNA酶、DNA酶和脂肪酶去除核酸和脂肪，得到保留血管胶原纤维和弹力纤维的天然脱细胞基质材料。
进一步，所述的内膜增生层由弹力纤维和蚕丝蛋白组成，所述的弹力纤维和蚕丝蛋白的质量比为，弹力纤维:蚕丝蛋白＝4:6。
进一步，所述的抗血栓药物层为药物肝素和明胶混合组成，所述的药物肝素和明胶的质量比为，药物肝素:明胶＝3:7，所述的肝素由葡萄糖胺，L-艾杜糖醛苷、N-乙酰葡萄糖胺和D-葡萄糖醛酸交替组成的黏多糖硫酸脂，平均分子量为15KD，呈强酸性。
与现有技术相比，该小口径组织改良复合型人工血管，能够达到以下效果；1、利于血管内皮细胞增殖的功能；2、具备很好的顺应性和细胞相容性，促进细胞的黏附、增殖和分化、铺展，完成血管的再内皮化；3、增加血管的力学性能，有利于平滑肌等细胞的侵入；4、提高人工血管抗血栓和促进血管内膜形成。
附图说明
图1是小口径组织改良复合型人工血管的立体图；
图2是小口径组织改良复合型人工血管的主视图；
图3是小口径组织改良复合型人工血管的局部放大图；
图4是外层组织的立体图；
图5是内层组织的立体图；
图6是胶联组织的立体图。
外层组织 1、 内层组织 2、
胶联组织 3、 混纺层 11、
微米颗粒孔 12、 主动脉弹力层 13、
去细胞心内膜 21、 内膜增生层 22、
抗血栓药物层 23、 N-羟基琥珀酰亚胺 31、
碳二亚胺 32。
如下具体实施方式将结合上述附图进一步说明。
具体实施方式
在下文中，阐述了多种特定细节，以便提供对构成所描述实施例基础的概念的透彻理解，然而，对本领域的技术人员来说，很显然所描述的实施例可以在没有这些特定细节中的一些或者全部的情况下来实践，在其他情况下，没有具体描述众所周知的处理步骤。
如图1、图2、图3、图4、图5、图6所示，包括外层组织1、内层组织2和胶联组织3，所述的外层组织1由混纺层11、微米颗粒孔12和主动脉弹力层13组成，所述的内层组织2由去细胞心内膜21、内膜增生层22和抗血栓药物层23组成，所述的胶联组织3由N-羟基琥珀酰亚胺31和碳二亚胺32组成，所述的内层组织2通过胶联组织3固设于外层组织1内部，所述的微米颗粒孔12数量为若干件，所述的微米颗粒孔12均匀分布于混纺层11内部，所述的主动脉弹力层13复合于混纺层11内侧，所述的内膜增生层22固设于去细胞心内膜21内侧，所述的抗血栓药物层23固设于内膜增生层22内侧，使用时：首先外层组织1混纺层11中的若干数量微米颗粒孔12作用，从而能够达到利于血管内皮细胞增殖的效果，且通过主动脉弹力层13的辅助作用，提高了抗拉伸强度、弹性摸量和可弯曲能力；其次由内层组织2中的去细胞心内膜21和内膜增生层22相互配合作用，具有很好的顺应性和细胞相容性，能够促进细胞的黏附、增殖和分化；同时配合抗血栓药物层23，能够提高人工血管抗血栓和促进血管内膜形成，最后通过胶联组织3中的N-羟基琥珀酰亚胺31和碳二亚胺32配合作用，继而能够实现外层组织1和内层组织2的连接复合，使其二者效果功能互补，大大加强了人工血管在临床实际的应用，促进了血管重塑与成熟；
所述的混纺层11由羧基化细菌纤维素、明胶和丝素蛋白组成，所述的羧基化细菌纤维素、明胶和蚕丝蛋白的质量比为，羧基化细菌纤维素:明胶:蚕丝蛋白＝1:0.5:8.5，所述的所述羧基化细菌纤维素的羧基含量大于20％，所述的羧基化细菌纤维素的羧基含量为20％-50％，所述的丝素蛋白为蚕丝中提取的天然高分子纤维蛋白，所述的天然高分子纤维蛋白内含丝氨酸和苏氨酸；需要说明的是羧基化细菌纤维素的制成是将细菌纤维素膜放入磷酸盐缓冲液中，接着加入TEMPO、NaClO2和NaClO在55-70℃下反应，最终获得羧基化细菌纤维素，通过羧基化细菌纤维素和丝素蛋白交联复合，不仅提高复合材料的血液相容性，且改善复合材料的弹性和表面性能，解决了人工小口径血管血液相容性较差、堵塞率较高等问题；
所述的微米颗粒孔12孔径为20～70μm，孔隙度为65％，需要说明的是通过20～70μm的孔径作用，能够便于血管内皮细胞增殖；
所述的主动脉弹力层13由天然脱细胞基质材料、蚕丝丝素和蚕丝蛋白溶液组成，所述的然脱细胞基质材料、蚕丝丝素和蚕丝蛋白溶液的质量比为，天然脱细胞基质材料:蚕丝丝素:蚕丝蛋白溶液＝2.3:7:0.7，所述的天然脱细胞基质材料是用胰酶脱细胞后，再用RNA酶、DNA酶和脂肪酶去除核酸和脂肪，得到保留血管胶原纤维和弹力纤维的天然脱细胞基质材料，需要说明的是通过高效温和的脱细胞方法，有效脱去细胞，并通过酶法有效去除DNA、RNA等免疫原性成分，因此保留了血管的弹力纤维、胶原纤维等细胞外基质的活性和功能；
所述的内膜增生层22由弹力纤维和蚕丝蛋白组成，所述的弹力纤维和蚕丝蛋白的质量比为，弹力纤维:蚕丝蛋白＝4:6；
所述的抗血栓药物层23为药物肝素和明胶混合组成，所述的药物肝素和明胶的质量比为，药物肝素:明胶＝3:7，所述的肝素由葡萄糖胺，L-艾杜糖醛苷、N-乙酰葡萄糖胺和D-葡萄糖醛酸交替组成的黏多糖硫酸脂，平均分子量为15KD，呈强酸性；需要说明的是肝素通过明胶修饰于内膜增生层22内侧，即借助肝素作用，来达到抗血栓目的；
综上，首先通过微孔结构的小口径，达到利于血管内皮细胞增殖的功能，其次通过天然脱细胞基质材料，从而具有很好的顺应性和细胞相容性，能够促进细胞的黏附、增殖和分化、铺展，完成血管的再内皮化；外层为丝素蛋白、羧基化细菌纤维素和明胶的混纺层，增加血管的力学性能，有利于平滑肌等细胞的侵入；内层的内表面可以用不同的药物修饰，如药物肝素，提高人工血管抗血栓和促进血管内膜形成，最终利于血管的重建。

Claims (9)

1.小口径组织改良复合型人工血管，其特征在于包括外层组织、内层组织和胶联组织，所述的外层组织由混纺层、微米颗粒孔和主动脉弹力层组成，所述的内层组织由去细胞心内膜、内膜增生层和抗血栓药物层组成，所述的胶联组织由N-羟基琥珀酰亚胺和碳二亚胺组成，所述的内层组织通过胶联组织固设于外层组织内部，所述的微米颗粒孔数量为若干件，所述的微米颗粒孔均匀分布于混纺层内部，所述的主动脉弹力层复合于混纺层内侧，所述的内膜增生层固设于去细胞心内膜内侧，所述的抗血栓药物层固设于内膜增生层内侧。
2.如权利要求1所述的小口径组织改良复合型人工血管，其特征在于所述的混纺层由羧基化细菌纤维素、明胶和丝素蛋白组成。
3.如权利要求2所述的小口径组织改良复合型人工血管，其特征在于所述的所述羧基化细菌纤维素的羧基含量大于20％。
4.如权利要求2所述的小口径组织改良复合型人工血管，其特征在于所述的丝素蛋白为蚕丝中提取的天然高分子纤维蛋白。
5.如权利要求1所述的小口径组织改良复合型人工血管，其特征在于所述的微米颗粒孔孔径为20～70μm，孔隙度为65％。
6.如权利要求1所述的小口径组织改良复合型人工血管，其特征在于所述的所述的主动脉弹力层由天然脱细胞基质材料、蚕丝丝素和蚕丝蛋白溶液组成。
7.如权利要求6所述的小口径组织改良复合型人工血管，其特征在于所述的天然脱细胞基质材料是用胰酶脱细胞后，再用RNA酶、DNA酶和脂肪酶去除核酸和脂肪，得到保留血管胶原纤维和弹力纤维的天然脱细胞基质材料。
8.如权利要求1所述的小口径组织改良复合型人工血管，其特征在于所述的内膜增生层由弹力纤维和蚕丝蛋白组成。
9.如权利要求1所述的小口径组织改良复合型人工血管，其特征在于所述的抗血栓药物层为药物肝素和明胶混合组成。
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