Ti-Ni形状记忆合金人工食管的研究
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摘要
食管癌是我国常见病,食管癌最有效的治疗方法仍是用外科手术切除病变食管,同时进行食管的重建。论文从生物相容性及力学相容性二个角度,系统深入研究了Ti-Ni形状记忆合金人工食管,提出了“带减张连接环的记忆合金人工食管”设计理念,从人工食管的构思和材料的选用二个方面,完成了“带减张连接环的记忆合金人工食管”的结构设计和制造工艺,并以实验猪为对象,建立了动物模型,开展动物实验研究,解决了不断蠕动的食管断端与外来的植入体之间连接的可靠性以及术后吻合口瘘和新生食管狭窄二个技术上的核心难题,为Ti-Ni形状记忆合金人工食管的临床应用进入实施,提供理论基础和切实可行的技术路线。
论文主要结论是:
1.研究表明,TiNi形状记忆合金无论在抗蚀性、细胞毒性和遗传毒性表现出良好特性,具有优异的生物相容性。但鉴于人体环境的复杂性,TiNi形状记忆合金植入人体后,周围环境不断地进行新陈代谢,其浸蚀介质也就不断地发生改变,在人工食管中使用该合金时,有必要进一步作体内实验与临床研究,以确保长期使用的安全性。
2.从生物相容性及力学相容性二个角度,提出了“带减张连接环的记忆合金人工食管”设计理念,申请了国家发明专利“新型人造腔管代用品”,获得了授权(专利号ZL01107515.5)。并从人工食管的构思和材料的选用二个方面,完成了“带减张连接环的记忆合金人工食管”的结构设计和制造。
3.以小型香猪为实验动物,针对‘带减张连接环的记忆合金人工食管’,通过手术方法建立动物实验模型,开展系统的动物实验,实验证实了:
用带涤纶连接环镍钛合金组合式人工食管替代胸段食管术后吻合口瘘发生率为0,而不带涤沦连接环的第一代镍钛合金组合式人工食管在替代胸段食管术后,吻合口瘘发生率达33.3%,二者之间有显著性差异。
替代胸段食管术后,脱管时间在66-200天之间,是不带涤纶连接环的人工食管的脱管时间的5倍。涤纶连接环的设计使人工食管与正常食管之间的连接变得更有效、可靠。
涤纶连接环的设计发挥了两个重要的作用:一是使人工食管与正常食管之间达到有效的连接,明显降低了缝合处张力和正常食管段蠕动对缝合处剪切力。二是在“新生食管”形成之前提供了足够三维空间支持的时间,使缝合口与“新生食管”之间得到充分愈合,长牢而不易撕裂。减张涤纶连接环的设计应用,有效地防止了镍钛合金组合式人工食管替代胸段食管术后,吻合口漏,早期脱管严重并发症的发生。
4,通过手术方法建立的‘带减张连接环的记忆合金人工食管’动物模型的系列实验,发现了依附在带减张连接环的记忆合金人工食管生长的“新生食管”,并观察到它的生长过程中的组织变化。
5,“新生食管”是包裹在植入的人工食管外壁周围的纤维结缔组织,形成的一条与两端吻合口正常食管组织相连续的密闭管道。新生食管的组织结构,其本质是一条通过纤维结缔组织修复为主,能再生出复层黏膜上皮、黏膜下肌层和腺体,肌层为瘢痕修复纤维结缔组织填充形成,没有收缩功能的瘢痕管道。
6,由于“新生食管”组织缺乏正常食管粘膜下层结构,“新生食管”中央狭窄部分疤痕组织萎缩,而内腔又没有人工食管管体的支撑,是新生食管发生狭窄的原因。新生食管狭窄往往发生在人工食管管体过早脱管的情况下。当新生食管在人工食管管体的支撑下的生长时间大于3个月,“新生食管”的管体结构由完整复层鳞状上皮覆盖的黏膜层,较丰富的变性粘膜下肌层和纤维外膜层组成。随着脱管时间的延长(大于三个月以上),新生食管的狭窄越来越轻,直至扩张。食管黏膜也变得接近正常。
7,人工食管(植入体)在原位停留时间2-3个月对形成一条具有通道功能的新生食管是必要的,停留时间越长,对形成具有通道功能的新生食管越有利。超过3个月发生人工食管脱落,新生食管已形成具有通道功能的管道,对进食影响不大,实验动物都能长期生存。
总之,近百年来,医学家和科学家都在百折不饶的研究开发人工食管,作为食管重建材料,人工食管的研究成果已成为食管癌的治疗这世界性技术难题的重要进展,我们的工作只是其中的一小部分。相信在医学家和科学家的共同努力下,人工食管的研究一定会获得成功,并将应用于各种原因导致的食管通道重建中。到那时,人类的食管癌的治疗、食管损伤的修复等方面就有了新的重大突破。
The esophageal cancer is a commonly encountered disease in China. The most effective remedy is the resection of the pathological esophagus and rebuilding a new esophagus. In the paper the research of artificial esophagus of TiNi SMA alloy from both of the biocompatibility and dynamic compatibility was carried out and the conception of the artificial esophagus of TiNi SMA alloy with connect collar was presented. Moreover, the artificial esophagus of TiNi SMA alloy with connect collar was designed and manufactured. With pigs the animal mould was built and a series of experimental animal researches were carried out. In the researches the technical puzzles, in which there are the link-reliability between the creeping esophagus and the allochthonous implant and the key problem about the anastomotic leakage and the stricture of‘newborn esophagus’after the esophageal manipulation, were solved. The research results offer a foundation and feasible technical program for the clinic application of the artifical esophagus of TiNi SMA alloy with connect collar.
The mean results in the paper were shown as following:
1. No matter what in anticorrosion, genetic toxicity and cytotoxicity TiNi SMA alloy presents good behaviors. It has excellent biocompatibility. However, since the complex of the human body ambient, it has to make the experiments of clinical toxicology in order to check the security in life-time service when the artificial esophagus uses the TiNi SMA alloy.
2. The conception of the artificial esophagus of TiNi SMA alloy with connect collar was presented from both of the biocompatibility and dynamic compatibility and the patented invention‘a new substitute of the artificial hose’has been authorized (the patent number is ZL01107515.5). And the product of the artificial esophagus of TiNi SMA alloy with connect collar was designed and manufactured.
3. With pigs the animal mould was built and a series of experimental animal researches were carried out. The results show as follows:
Using the artificial esophagus of TiNi SMA alloy with connect collar, the ratio of the anastomotic leakage after the esophageal manipulation is zero, but without the connect collar the ratio of that is about 33.3%. The difference between the two ratios of the anastomotic leakage is significant.
The time of the breaking off of the allochthonous implant after the esophageal manipulation with the artificial esophagus of TiNi SMA alloy with connect collar is at 66-220 days, which is about 5 times longer than that after the esophageal manipulation with the artificial esophagus of TiNi SMA alloy without connect collar. The design of the artificial esophagus of TiNi SMA alloy with connect collar makes the link-reliability between the creeping esophagus and the allochthonous implant more effective and reliable.
The use of the artificial esophagus of TiNi SMA alloy with connect collar effectively avoid the anastomotic leakage and the prerelease of the allochthonous implant after the esophageal manipulation.
4. The‘newborn esophagus’grown adherent to the surface of the artificial esophagus of TiNi SMA alloy with connect collar after the esophageal manipulation was discovered in a series of experimental animal researches with pigs as the animal mould .
5. The microstructure of the‘newborn esophagus’is a fibrous connective tissue encapsulated the artificial esophagus, which forms an enclosed anastomotic vessel linked with the normal esophagus. The‘newborn esophagus’essentially is a cicatrix hose filled up with the fibrous connective tissue which is without pinch-dilation effect.
6. Since the microstructure of the‘newborn esophagus’lacks the mucous membrane in the normal esophagus, the microstructure at the center of the‘newborn esophagus’can be atrophic scar. If in the entocoele of the‘newborn esophagus’does not fasten with a hose of the artificial esophagus, the stricture of‘newborn esophagus’after the esophageal manipulation will occur. So the stricture of‘newborn esophagus’after the esophageal manipulation appears at the case of the prerelease of the allochthonous implant after the esophageal manipulation. When growth time of the‘newborn esophagus’under poling of the hose of the artificial esophagus is greater than 3 months, the microstructure of the‘newborn esophagus’build up with a mucous layer covered the squamous epithelium layers completely, a more prolific degenerative mucous muscle layer and fibrous membrane. The longer the time of the breaking off of the allochthonous implant after the esophageal manipulation is (> 3 months), the more slight the stricture of‘newborn esophagus’after the esophageal manipulation is. And the structure of the mucous membrane in the‘newborn esophagus’becomes normal structure with elongation of the breaking off of the allochthonous implant.
7. It is necessary that the stay time at the original position for the artificial esophagus (the allochthonous implant) is about 2-3 months in order to form a‘newborn esophagus’which is as a channels passing foodstuff. The longer the time of the breaking off of the allochthonous implant after the esophageal manipulation is, the better the‘newborn esophagus’which is as a channel passing foodstuff grows. When the time of the breaking off of the allochthonous implant after the esophageal manipulation is greater than 3 months the‘newborn esophagus’will form as a channels which can be trouble-free passed for foodstuff. Thus the experimental animal will exist for long-time without any doubt.
In brief, for the passed near a hundred years the artificial esophagus as the esophagus allochthonous implant has being exploited and developed indomitably by the doctors and scientists in the world. The research results including our research have been the important advance in the solusion of the worldwide puzzle about the treatment of the esophagus cancer. It is sure that the research of the artificial esophagus as the esophagus allochthonous implant will be success and the achievement will be used in the rebuilding of the esophagus since various reasons. And the prevention against to the esophagus cancer and esophagus injury will have a great progress.
论文主要结论是:
1.研究表明,TiNi形状记忆合金无论在抗蚀性、细胞毒性和遗传毒性表现出良好特性,具有优异的生物相容性。但鉴于人体环境的复杂性,TiNi形状记忆合金植入人体后,周围环境不断地进行新陈代谢,其浸蚀介质也就不断地发生改变,在人工食管中使用该合金时,有必要进一步作体内实验与临床研究,以确保长期使用的安全性。
2.从生物相容性及力学相容性二个角度,提出了“带减张连接环的记忆合金人工食管”设计理念,申请了国家发明专利“新型人造腔管代用品”,获得了授权(专利号ZL01107515.5)。并从人工食管的构思和材料的选用二个方面,完成了“带减张连接环的记忆合金人工食管”的结构设计和制造。
3.以小型香猪为实验动物,针对‘带减张连接环的记忆合金人工食管’,通过手术方法建立动物实验模型,开展系统的动物实验,实验证实了:
用带涤纶连接环镍钛合金组合式人工食管替代胸段食管术后吻合口瘘发生率为0,而不带涤沦连接环的第一代镍钛合金组合式人工食管在替代胸段食管术后,吻合口瘘发生率达33.3%,二者之间有显著性差异。
替代胸段食管术后,脱管时间在66-200天之间,是不带涤纶连接环的人工食管的脱管时间的5倍。涤纶连接环的设计使人工食管与正常食管之间的连接变得更有效、可靠。
涤纶连接环的设计发挥了两个重要的作用:一是使人工食管与正常食管之间达到有效的连接,明显降低了缝合处张力和正常食管段蠕动对缝合处剪切力。二是在“新生食管”形成之前提供了足够三维空间支持的时间,使缝合口与“新生食管”之间得到充分愈合,长牢而不易撕裂。减张涤纶连接环的设计应用,有效地防止了镍钛合金组合式人工食管替代胸段食管术后,吻合口漏,早期脱管严重并发症的发生。
4,通过手术方法建立的‘带减张连接环的记忆合金人工食管’动物模型的系列实验,发现了依附在带减张连接环的记忆合金人工食管生长的“新生食管”,并观察到它的生长过程中的组织变化。
5,“新生食管”是包裹在植入的人工食管外壁周围的纤维结缔组织,形成的一条与两端吻合口正常食管组织相连续的密闭管道。新生食管的组织结构,其本质是一条通过纤维结缔组织修复为主,能再生出复层黏膜上皮、黏膜下肌层和腺体,肌层为瘢痕修复纤维结缔组织填充形成,没有收缩功能的瘢痕管道。
6,由于“新生食管”组织缺乏正常食管粘膜下层结构,“新生食管”中央狭窄部分疤痕组织萎缩,而内腔又没有人工食管管体的支撑,是新生食管发生狭窄的原因。新生食管狭窄往往发生在人工食管管体过早脱管的情况下。当新生食管在人工食管管体的支撑下的生长时间大于3个月,“新生食管”的管体结构由完整复层鳞状上皮覆盖的黏膜层,较丰富的变性粘膜下肌层和纤维外膜层组成。随着脱管时间的延长(大于三个月以上),新生食管的狭窄越来越轻,直至扩张。食管黏膜也变得接近正常。
7,人工食管(植入体)在原位停留时间2-3个月对形成一条具有通道功能的新生食管是必要的,停留时间越长,对形成具有通道功能的新生食管越有利。超过3个月发生人工食管脱落,新生食管已形成具有通道功能的管道,对进食影响不大,实验动物都能长期生存。
总之,近百年来,医学家和科学家都在百折不饶的研究开发人工食管,作为食管重建材料,人工食管的研究成果已成为食管癌的治疗这世界性技术难题的重要进展,我们的工作只是其中的一小部分。相信在医学家和科学家的共同努力下,人工食管的研究一定会获得成功,并将应用于各种原因导致的食管通道重建中。到那时,人类的食管癌的治疗、食管损伤的修复等方面就有了新的重大突破。
The esophageal cancer is a commonly encountered disease in China. The most effective remedy is the resection of the pathological esophagus and rebuilding a new esophagus. In the paper the research of artificial esophagus of TiNi SMA alloy from both of the biocompatibility and dynamic compatibility was carried out and the conception of the artificial esophagus of TiNi SMA alloy with connect collar was presented. Moreover, the artificial esophagus of TiNi SMA alloy with connect collar was designed and manufactured. With pigs the animal mould was built and a series of experimental animal researches were carried out. In the researches the technical puzzles, in which there are the link-reliability between the creeping esophagus and the allochthonous implant and the key problem about the anastomotic leakage and the stricture of‘newborn esophagus’after the esophageal manipulation, were solved. The research results offer a foundation and feasible technical program for the clinic application of the artifical esophagus of TiNi SMA alloy with connect collar.
The mean results in the paper were shown as following:
1. No matter what in anticorrosion, genetic toxicity and cytotoxicity TiNi SMA alloy presents good behaviors. It has excellent biocompatibility. However, since the complex of the human body ambient, it has to make the experiments of clinical toxicology in order to check the security in life-time service when the artificial esophagus uses the TiNi SMA alloy.
2. The conception of the artificial esophagus of TiNi SMA alloy with connect collar was presented from both of the biocompatibility and dynamic compatibility and the patented invention‘a new substitute of the artificial hose’has been authorized (the patent number is ZL01107515.5). And the product of the artificial esophagus of TiNi SMA alloy with connect collar was designed and manufactured.
3. With pigs the animal mould was built and a series of experimental animal researches were carried out. The results show as follows:
Using the artificial esophagus of TiNi SMA alloy with connect collar, the ratio of the anastomotic leakage after the esophageal manipulation is zero, but without the connect collar the ratio of that is about 33.3%. The difference between the two ratios of the anastomotic leakage is significant.
The time of the breaking off of the allochthonous implant after the esophageal manipulation with the artificial esophagus of TiNi SMA alloy with connect collar is at 66-220 days, which is about 5 times longer than that after the esophageal manipulation with the artificial esophagus of TiNi SMA alloy without connect collar. The design of the artificial esophagus of TiNi SMA alloy with connect collar makes the link-reliability between the creeping esophagus and the allochthonous implant more effective and reliable.
The use of the artificial esophagus of TiNi SMA alloy with connect collar effectively avoid the anastomotic leakage and the prerelease of the allochthonous implant after the esophageal manipulation.
4. The‘newborn esophagus’grown adherent to the surface of the artificial esophagus of TiNi SMA alloy with connect collar after the esophageal manipulation was discovered in a series of experimental animal researches with pigs as the animal mould .
5. The microstructure of the‘newborn esophagus’is a fibrous connective tissue encapsulated the artificial esophagus, which forms an enclosed anastomotic vessel linked with the normal esophagus. The‘newborn esophagus’essentially is a cicatrix hose filled up with the fibrous connective tissue which is without pinch-dilation effect.
6. Since the microstructure of the‘newborn esophagus’lacks the mucous membrane in the normal esophagus, the microstructure at the center of the‘newborn esophagus’can be atrophic scar. If in the entocoele of the‘newborn esophagus’does not fasten with a hose of the artificial esophagus, the stricture of‘newborn esophagus’after the esophageal manipulation will occur. So the stricture of‘newborn esophagus’after the esophageal manipulation appears at the case of the prerelease of the allochthonous implant after the esophageal manipulation. When growth time of the‘newborn esophagus’under poling of the hose of the artificial esophagus is greater than 3 months, the microstructure of the‘newborn esophagus’build up with a mucous layer covered the squamous epithelium layers completely, a more prolific degenerative mucous muscle layer and fibrous membrane. The longer the time of the breaking off of the allochthonous implant after the esophageal manipulation is (> 3 months), the more slight the stricture of‘newborn esophagus’after the esophageal manipulation is. And the structure of the mucous membrane in the‘newborn esophagus’becomes normal structure with elongation of the breaking off of the allochthonous implant.
7. It is necessary that the stay time at the original position for the artificial esophagus (the allochthonous implant) is about 2-3 months in order to form a‘newborn esophagus’which is as a channels passing foodstuff. The longer the time of the breaking off of the allochthonous implant after the esophageal manipulation is, the better the‘newborn esophagus’which is as a channel passing foodstuff grows. When the time of the breaking off of the allochthonous implant after the esophageal manipulation is greater than 3 months the‘newborn esophagus’will form as a channels which can be trouble-free passed for foodstuff. Thus the experimental animal will exist for long-time without any doubt.
In brief, for the passed near a hundred years the artificial esophagus as the esophagus allochthonous implant has being exploited and developed indomitably by the doctors and scientists in the world. The research results including our research have been the important advance in the solusion of the worldwide puzzle about the treatment of the esophagus cancer. It is sure that the research of the artificial esophagus as the esophagus allochthonous implant will be success and the achievement will be used in the rebuilding of the esophagus since various reasons. And the prevention against to the esophagus cancer and esophagus injury will have a great progress.
引文
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