非均质镍钛合金超弹性三尖瓣成型环的长期动物实验研究

doi:10.3969/j.issn.0258-8021.2025.04.008

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摘要通过长期体内观察实验,验证一种以镍钛合金为基体的3D结构的三尖瓣成型环在植入小尾寒羊体内后能否长时间有效工作以及了解其生物相容性。为实现这一目的,在体外循环辅助下将12枚实验品和9枚对照品植入21只小尾寒羊体内。于术前、术后90和180 d时测量体重评估动物生长情况;采集血液进行血常规、生化和游离血红蛋白检测,监测动物有无感染和观察成型环与血液间的相互作用;采用经胸超声心动图方法评估动物三尖瓣功能、心脏结构改变、及血栓形成情况。按计划完成检查后安乐死动物,采用大体病理、组织病理和显微电镜方法观察实验品和对照品的结构完整性、局部病理学改变,评估成型环假体局部炎症反应水平和表面内皮化程度。成型环假体植入后两组动物体重均持续增长,术后180 d时分别达到(51.7±4.5)kg和(55.5±5.2)kg。血液学结果表明,整个实验过程中两组动物未发生感染,所有成形环假体在与血液长时间接触过程中均未引发溶血,未造成血细胞和肝肾功能发生异常改变。超声发现整个实验过程中两组动物三尖瓣跨瓣压差(TVPG)均低于5 mmHg,三尖瓣能正常工作,瓣膜表面未探及血栓。病理结果表明,在两个观察终点所有成形环假体结构完整,与受体三尖瓣环贴合紧密,未发生折断、开裂和变形,表面均已形成完整的纤维囊,术后180 d时两组动物周围局部炎症反应评分分别为4.7±1.5和5.4±2.2、内皮化率分别为74%±38% 和82%±29%。实验结果提示,该非均质镍钛合金超弹性三尖瓣成型环在植入小尾寒羊体内后能够长时间维持三尖瓣正常结构,三尖瓣可正常发挥作用,具有较好的血液相容性和生物相容性。

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	贾六军
	岳广新
	贺婷
	姜昕
	张琪
	范珺莹
	宋江平

关键词 ：三尖瓣成型环, 钛镍合金, 生物相容性, 安全性, 动物实验

Abstract：To evaluate whether a heterogeneous 3D tricuspid annuloplasty ring made of a hyperelastic nitinol can work effectively for a long time after implantation and to reveal its biocompatibility, 12 experimental samples (PerMed rings) and 9 control samples (Edward MC3 rings) were implanted into 21 small tailed Han sheep under circulation bypass. Pre-implantation, and at post implantation day (PID) 90 and PID 180, body weight was taken to assess animal growth, blood was collected for complete blood count, blood chemistries and free hemoglobin test to monitor infection and observe the interaction between the “rings” and blood, and the tricuspid valve function, cardiac structural changes, and thrombus formation was evaluated through transthoracic echocardiography (TTE). Then the animals were euthanized according to the plan, the integrity and local pathological changes, the local inflammatory response level and endothelialization of the prosthesis were evaluated by autopsy, histopathology, and SEM. Animals of both groups had good weight gain after surgery, with BW reaching (51.7±4.5) kg and (55.5±5.2) kg at post implantation day 180. Complete blood count showed there was no infection. Both types of prostheses did not cause hematolysis, abnormal changes in blood cells or hepatic/nephric dysfunction. TTE revealed that TVPG of animals from each group below 5 mmHg throughout the experiment, the tricuspid valves all worked normally, and no thrombus was detected. The pathology results showed all prostheses remained intact structures, closely adhered to the recipient tricuspid annulus, and did not break, crack, or deform, both types of rings had intact fibrous sacs on their surfaces. The local inflammatory response scores were (4.7±1.5) and (5.4±2.2) and the endothelialization rates were (74%±38%) and (82%±29%), respectively at post implantation day 180. The above results indicated that the heterogeneous tricuspid annuloplasty ring made of a hyperelastic Nitinol maintained tricuspid valve function safely and effectively for a long time, and with good blood compatibility and biocompatibility after being implanted into the small tailed Han sheep.

Key words： tricuspid annuloplasty ring nitinol biocompatibility safety animal experiments

收稿日期: 2024-04-25

PACS:

R318

基金资助:心血管植入材料临床前研究评价北京市重点实验室主任基金(ZR03)

通讯作者: ^*E-mail:fwsongjiangping@126.com

引用本文:

贾六军, 岳广新, 贺婷, 姜昕, 张琪, 范珺莹, 宋江平. 非均质镍钛合金超弹性三尖瓣成型环的长期动物实验研究[J]. 中国生物医学工程学报, 2025, 44(4): 457-464.
Jia Liujun, Yue Guangxin, He Ting, Jiang Xin, Zhang Qi, Fan Junying, Song Jiangping. Long Term Animal Experimental Study on a Heterogeneous Tricuspid Annuloplasty Ring Madeof a Hyperelastic Nitinol. Chinese Journal of Biomedical Engineering, 2025, 44(4): 457-464.

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http://cjbme.csbme.org/CN/10.3969/j.issn.0258-8021.2025.04.008 或 http://cjbme.csbme.org/CN/Y2025/V44/I4/457

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