With the development of the economy and technological progress,more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement.Owing to the complexity of their structure and production process,these animal-derived meshes still face several challenges in practical applications,such as insufficient mechanical strength,rapid degradation rates,and the detection of harmful leachable substances.Among these challenges,the production process is a key factor affecting product quality.This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China,offering new insights for the quality control and regulatory oversight of such products.

The effect and mechanism of type III recombinant humanized collagen (hCOLIII) on human vascular endothelial EA.hy926 cells at the cellular and molecular levels were investigated. The impact of hCOLIII on the proliferation of EA.hy926 cells was detected by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromid assay, the effect of hCOLIII on cell migration was investigated by scratch assay, the impact of hCOLIII on cell cycle and apoptosis was detected by flow cytometry, the ability of hCOLIII to induce angiogenesis of EA.hy926 cells was evaluated by angiogenesis assay, and the effect of hCOLIII on vascular endothelial growth factor (VEGF) expression was detected by real-time reverse transcription-polymerase chain reaction analysis. The hCOLIII at concentrations of 0.5, 0.25, and 0.125 mg/mL all showed specific effects on the proliferation and migration of human vascular endothelial cells. It could also affect the cell cycle, increase the proliferation index, and increase the expression level of VEGF in human vascular endothelial cells. In the meantime, hCOLIII at the concentration of 0.5 mg/mL also showed a promoting effect on vessel formation. hCOLIII can potentially promote the endothelization process of blood vessels, mainly by affecting the proliferation, migration, and vascular-like structure of human endothelial cells. At the same time, hCOLIII can promote the expression of VEGF. This collagen demonstrated its potential as a raw material for cardiovascular implants.

Cardiovascular disease has become one of the main causes of death. It is the common goal of researchers worldwide to develop small-diameter vascular grafts to meet clinical needs. Collagen is a valuable biomaterial that has been used in the preparation of vascular grafts and has shown good results. Recombinant humanized collagen (RHC) has the advantages of clear chemical structure, batch stability, no virus hazard and low immunogenicity compared with animal-derived collagen, which can be developed as vascular materials. In this study, Poly (l-lactide- ε-caprolactone) with l-lactide/ε-caprolactone (PLCL) and type III recombinant humanized collagen (hCOLIII) were selected as raw materials to prepare vascular grafts, which were prepared by the same-nozzle electrospinning apparatus. Meanwhile, procyanidin (PC), a plant polyphenol, was used to cross-link the vascular grafts. The physicochemical properties and biocompatibility of the fabricated vascular grafts were investigated by comparing with glutaraldehyde (GA) crosslinked vascular grafts and pure PLCL grafts. Finally, the performance of PC cross-linked PLCL-hCOLIII vascular grafts were evaluated by rabbit carotid artery transplantation model. The results indicate that the artificial vascular grafts have good cell compatibility, blood compatibility, and anti-calcification performance, and can remain unobstructed after 30 days carotid artery transplantation in rabbits. The grafts also showed inhibitory effects on the proliferation of SMCs and intimal hyperplasia, demonstrating its excellent performance as small diameter vascular grafts.

随着经济发展和技术进步,医疗美容的需求大幅增加,医用生物材料大量应用,其有效性和安全性的评价有必要进一步提高.目前,国内所采用的是理化性质及生物学评价,然而临床上的有效性是一个多方面的评价,无统一标准,大多主要采用客观指标量化分析,主观感受属于次要标准.本文对目前主要的面部填充物及其理化性能评价方法进行综述.

目的 探讨新型"瓣中瓣"技术——经导管瓣中瓣对治疗"二次瓣膜病变"患者的有效性.方法 以人体真实血流流量波形为基准,构建体外循环流动系统,采用粒子图像测速技术对人工心脏瓣膜下游血管内流场进行重构,在获取运动学信息的基础上引入时间平均壁面剪切应力、震荡剪切指数、相对停留时间等动力学参数,对经导管瓣中瓣以及经导管瓣膜的性能进行评估.结果 分析心脏收缩早期、收缩峰值期、收缩晚期以及舒张早期四个特征状态,在流量较大时,经导管瓣中瓣会因诱发返流而导致一定程度的流动不稳定,但其性能总体上与经导管瓣膜相同,可在宽流量范围内正常使用.结论 本文建立了一套有效的瓣膜下游流场动力学参数瓣膜性能体外评估体系,可对新型经导管瓣中瓣结构的适用性提供实验依据.

目的 随着之前植入外科人工生物心脏瓣膜患者瓣膜毁损的病例增加,介入瓣膜瓣中瓣越来越多地被用于临床.由于其临床应用时间不长,目前没有长期临床数据可以参考,故实验采用体外加速方法,对一种介入瓣膜瓣中瓣耐久性能进行测试及评价.方法 将23 mm、27 mm、29 mrm 3个规格(牛心包材质)介入瓣膜作为瓣中瓣分别安装在23 mm、27 mm、29 mm对应规格外科生物心脏瓣膜中,通过预扩达到相同的内径后进行体外加速疲劳耐久性能测试,每5000万次对其脉动流性能进行测试.2.0亿次疲劳测试后,对瓣叶进行热力学分析、双光子共聚焦显微镜下观察瓣叶胶原纤维结构.结果 经过2.0亿次耐久性能测试,介入瓣膜瓣中瓣平均跨瓣压差无显著变化[23 mm:1.92～1.98 kPa(14.4～14.9 mmHg);27 mm:0.92～1.64 kPa(6.9～12.3 mmHg);29 mm:0.72～1.02 kPa(5.4～7.4 mmHg)],有效瓣口面积基本一致(23 mm:1.45～1.66 cm2;27 mm:1.88～ 2.17 cm2;29 mm:2.24～2.54 cm2),反流百分比减小(23mm:7.2％～3.3 ％;27 mm:14.9％～3.3 ％;29 mm:14.7％～3.9％),脉动流性能满足YY/T 1449.3-2016标准的要求,具有良好的脉动流性能.瓣叶材料的热力学变性温度降低,从(105.4±0.9)℃变为(98.1±0.5)℃(P＜0.05).瓣叶材料中胶原纤维形状发生变化,由疲劳测试前卷曲的立体结构变为疲劳测试后波浪形线状结构.结论 经过模拟临床使用5年(2.0亿次)体外疲劳测试后,虽然介入瓣膜瓣中瓣瓣叶材料发生蠕变,胶原蛋白纤维结构发生变化,热变性温度降低,但瓣膜整体仍具有良好的流体力学性能.

随着生物技术的发展,近年来出现了通过覆盖钙结合位点的牛心包处理技术,并以此为瓣叶材料制备出干性生物瓣膜.由于干性生物瓣膜临床应用时间短,尚缺少长期耐久性数据.本研究采用体外加速方法,对一种干性生物瓣膜耐久性能进行测试及评价.选取23和32 mm这两个规格干性生物瓣膜进行体外耐久性能测试.通过瓣膜脉动流实验、瓣叶热力学分析和显微镜下胶原纤维观察,对其耐久性能进行评价.经过2亿次循环(模拟临床使用5年),干性生物瓣膜流体力学性能无明显变化,其中23 mm规格干性生物瓣膜平均跨瓣压差有所升高,但仍处于同规格生物瓣膜较低水平;32 mm规格干性生物瓣膜平均跨瓣压差几乎没有变化.有效瓣口面积基本一致,返流百分比无明显变化,说明干性生物瓣膜未发生明显的狭窄和返流,能量损失无明显变化,说明瓣膜的效能无明显降低.瓣叶材料的热力学变性温度由96.6℃降至91.2℃;在双光子共聚焦显微镜下观察,同样测试条件下亮度变暗,但胶原纤维形状未发生变化,仍是卷曲的立体结构,说明胶原纤维含量降低,化学键部分丢失,与热变性温度表现一致.干性生物瓣膜耐久性能实验后,微观结构发生一定变化,但仍具有良好的流体力学性能.

介绍可降解血管支架不溶性微粒的危害及来源,列举可降解血管支架不溶性微粒的评价方法,并分析可降解血管支架的不溶性微粒评价的发展趋势.

Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.

目的:建立可吸收支架耐疲劳测试的评价体系,为可吸收冠脉支架的安全性和有效性评价提供测试手段.方法:模拟人体血管内的受力、温度和腐蚀环境,在1.2 Hz频率下,对可吸收冠脉支架进行18662400次脉动的疲劳实验,相当于植入人体6个月.实验结束后对支架的整体情况和微观形态进行观测.结果:支架在疲劳实验后,未出现移位、弯曲、塌陷或裂缝等问题.支架药物涂层表面总体完整性较好,无分层、剥落、翘起、支架基体裸露等现象.结论:通过研究初步建立了可吸收冠脉支架耐疲劳性能的评价体系,评价方法对可吸收冠脉支架的安全性和有效性提供了合理的检测手段.

目的:针对经导管植入式人工心脏瓣膜特殊的植入方式和固定方式引入的新风险,设计体外脉动流测试,对经导管瓣膜临床使用过程中的风险进行评估.方法:选择自膨式经导管主动脉瓣膜,在脉动条件下,经模拟血管系统将瓣膜植入脉动流测试腔,在非圆型测试腔中测试返流百分比、跨瓣压差、有效瓣口面积参数,增大反向压力,测试瓣膜移位量.结果:测试瓣膜均可以顺利完成模拟植入试验,准确释放在主动脉瓣膜测试腔中.脉动流性能试验中,随着瓣膜尺寸的增大,返流百分比增大,瓣膜跨瓣压差减小,有效开口面积增大.在180 mmHg反向压力下,测试瓣膜发生微小移位.结论:研究建立的经导管瓣膜体外脉动流测试方法,模拟了经导管瓣膜临床使用条件,对经导管瓣膜体外脉动流性能进行了更加全面的评价,可以作为经导管瓣膜临床前体外评价的参考.

目的:比较相同工艺下异体真皮补片和牛心包补片的力学性能,为相关行业的产品研发和临床使用提供参考.方法:使用力学实验设备对A和B厂家的牛心包补片,以及C和D厂家的异体真皮补片的拉伸强度、断裂伸长率、缝合强度进行测试和统计学分析.结果:A和B厂家牛心包补片的拉伸强度、断裂伸长率、缝合强度均无显著性差异(P＞0.05),样本总体的均值分别为23.18MPa、32.84％和11.46 N,标准偏差分别为2.85、5.08、1.46.C和D厂家异体真皮补片的拉伸强度、断裂伸长率、缝合强度均无显著性差异(P＞0.05),样本总体的均值分别为8.91 MPa、65.64％和22.71 N,标准偏差分别为0.77、4.84、2.78.牛心包补片和异体真皮补片之间的力学性能有极显著差异(P＜0.01).结论:实验结果显示,相较于异体真皮补片,牛心包补片在拉伸强度方面表现更好,而断裂伸长率和缝合强度方面异体真皮补片表现更优.

目的 比较同种异体和动物源性补片的力学性能,为相关行业的产品研发和临床使用提供参考.方法 使用力学实验设备对同种异体补片、猪源性补片、牛源性补片的拉伸强度、断裂伸长率、缝合强度进行测试及统计学分析.结果 力学测试结果显示,猪源性补片在拉伸强度和缝合强度两个方面与同种异体补片差异无统计学意义(分别为9.31 MPa vs 9.37 MPa,P>0.05;24.48 N vs 22.18 N,P>0.05),而牛源性补片的拉伸强度较高(22.73 MPa,P<0.01),缝合强度较低(11.97 N,P<0.01),在断裂伸长率方面同种异体补片明显高于猪源性补片和牛源性补片(68.49％vs 40.18％vs 31.61％,P<0.01).结论 猪源性补片与同种异体补片具有部分的力学相近性,但同种异体补片在断裂伸长率方面与动物源性补片的差异具有统计学意义.

心血管介入治疗技术是治疗心血管疾病的重要手段,永久金属支架虽然可以为冠脉狭窄提供支撑,但其在血管内长期存留可引起血管的慢性损伤,后期可造成血管中层萎缩、动脉瘤形成以及反应性内膜增生,最终导致血管再狭窄.随着科学技术的发展和实验的探索,生物可吸收支架正在逐步替代金属永久支架,成为冠状动脉介入治疗发展的新方向.国产冠脉支架的发展经历了模仿、改进、创新的漫长历程,目前新型的生物可吸收冠状动脉支架已经取得了可喜的阶段性研究成果.本文综述了几种国产新型生物可吸收支架的发展情况,归纳其各自的特点和临床试验结果,分析了当前的问题,并对未来的发展做了展望.

目的:通过橡胶外科手套不透水性试验能力验证计划,了解医疗器械检验机构检验能力,提高橡胶外科手套质量检测水平.方法:按照CNAS批准的能力验证方案,通过制备样品,经过稳定性和均匀性检验合格,作为能力验证样品.采用随机编号发样给参加单位,并附作业指导书.参加实验室在规定时限提交检验报告和原始记录复印件,判定准则采取专家公议,针孔漏检率:≤25％,表明"满意",25％35％,表明"不满意".结果:共有34个实验室参加本次能力验证项目,其中提交满意结果的实验室有32个,占总参加机构的94.1％,不满意的实验室有2个,占5.9％.结论:医疗器械检验机构在橡胶外科手套不透水性检验能力较高,实施能力验证计划能够反映实验室的检测水平.

目的:评估聚氨酯人工血管的综合物理性能.方法:参照行业标准YY0500-2004《心血管植入物人工血管》中的方法,测试聚氨酯人工血管的轴向拉伸强度、周向拉伸强度、薄膜加压破裂强度、缝线牵拉强度、反复穿刺后强度、渗透性以及扩张内径.结果:试验得到样品各测试项目的均值分别为轴向拉伸强度770.81 N、周向拉伸强度6.71 N·mm-1、薄膜加压破裂强度294.78 kPa、缝线牵拉强度34.89N、反复穿刺后强度2264mmHg、渗透性为0 mL·min-1、扩张内径2.20％.结论:加强型聚氨酯材料人工血管有较好的综合物理性能,具有较高的临床应用价值.

钛合金材料因为其优异的生物相容性和力学相容性而被大量的研究开发,成为骨科植入物的主要原材料.制备与人体组织有更好的相容性、更接近于人体的弹性模量的新型低模量钛合金已经成为该领域研究的热点.本文从新型低模量钛合金材料设计、研究现状及其骨科植入临床前研究几个方面进行了综述,总结了近几年国内外低模量钛合金骨科植入物材料的最新进展,展望了未来发展趋势及待解决的问题.