Development of nitinol-based stent-graft for the treatment of aortic aneurysms : with special reference to a thin and flexible stent-graft system.

开发用于治疗主动脉瘤的镍钛合金支架移植物：特别是薄而灵活的支架移植物系统。

• 批准号: 11670875
• 负责人: MATSUI Osamu
• 金额: $ 2.43万
• 依托单位: Kanazawa University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 1999
• 资助国家: 日本
• 起止时间: 1999 至 2000
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-11670875/
• 关键词: Metallic stent; Stent-graft; Nitinol; Percutaneous transluminal angioplasty; Aortic aneurysm; Artificial blood vessel; Endovascular surgery; International angiography; ステント; 血管拡張術; 血管造影

The purpose of this study was to develop a thin and flexible stent-graft system with homogeneous attachment to the entire aortic wall. According to our previous experimental study, we constructed a new type of nitinol based mesh type stent made of one nitinol (0.30mm wire, distances between each wires was 4-5mm in 20-30mm diameter stent) wire covered with thin polyester membrane (0.1mm thickness, porosity 500-1000, woven type). This stent-graft was examined in vivo and it was well tolerated by strength and vibration tests (almost the same radial force as that of Z stent, slight erosion of the wires was seen in vibration test comparable to more than 8 years heart beats counts). In vitro examination in aorta of the dogs revealed good patency of the aorta and blockade of its branches. After these basic tests, this new type of stent- graft was used for the inoperable emergent cases of aortic aneurysms after intense informed consent. Until March 2001, around 30 cases of inonerable emergent cases of aortic aneurysm were treated by this system. No definite system-related complications were seen. This flexible stent-graft system well fitted the tortuous aortas. Final exclusion of the aortic aneurysm was seen around 90% of cases. Further evaluation of these cases is now undergoing. In addition, the basic evaluation of this system in vivo and in animals is also being performed for further improvement of this system and for the development of more advanced system.

本研究的目的是开发一种薄且柔性的覆膜支架系统，其均匀附着于整个主动脉壁。根据我们以前的实验研究，我们构建了一种新型的镍钛合金网状支架，该支架由一根镍钛合金（0.30mm金属丝，直径20- 30 mm支架中每根金属丝之间的距离为4- 5 mm）金属丝覆盖薄聚酯膜（0.1mm厚，孔隙率500-1000，编织型）制成。对该覆膜支架进行了体内检查，通过强度和振动试验，其耐受性良好（径向力几乎与Z支架相同，在振动试验中观察到金属丝轻微腐蚀，与8年以上的心跳计数相当）。离体犬主动脉检查显示主动脉通畅，分支阻断。经过这些基本的测试，这种新型的覆膜支架在严格的知情同意后被用于无法手术的主动脉瘤急诊病例。截至2001年3月，该系统已治疗了约30例难以治愈的主动脉瘤急诊病例。未观察到明确的系统相关并发症。这种柔性覆膜支架系统与迂曲的动脉吻合良好。约90%的病例最终排除了主动脉瘤。目前正在对这些案件作进一步评估。此外，该系统在体内和动物中的基本评价也正在进行，以进一步改进该系统和开发更先进的系统。

项目成果

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Matsuoka T.：“血管内移植的实验研究 - 特别参考主动脉壁流动性 Wallstent、螺旋 Z 型支架和覆盖支架放置的变化。”J.Juzen Med Soc.. 106. 721-735 (1997)

Sanada J, Matsui O,Yoshikawa J,et al.: "An experimental study of endovascular stenting with special reference to the effects on the aortic vasa vasorum."Cadiovasc.Intervent.Radiol.. 21(1). 45-49 (1998)

Sanada J、Matsui O、Yoshikawa J 等人：“血管内支架置入术的实验研究，特别是对主动脉血管滋养管的影响。”Cadiovasc.Intervent.Radiol.. 21(1)。

Yoshikawa S.Matsui O. et al: "Interventional Radiology"Transcatheter management of hepatic tumors. Combined treatment and other modifications. Han. Ch, Park 5H,eds. Ilchekak, Seoul, Korea. 776 (1999)

Yoshikawa S.Matsui O.等人：“介入放射学”肝肿瘤的经导管治疗。

Yamauchi T, Furui S, Matsui O et al.: "Saline-jet aspiration thrombectomy catheter : clinical results in patients with venous thrombosis"Acta Radiologica. 40. 207-210 (1999)

Yamauchi T、Furui S、Matsui O 等人：“盐水喷射抽吸血栓切除导管：静脉血栓形成患者的临床结果”Acta Radiologica。

Nomura M,Kida S,Yamashita T, et al.: "Percutaneous transluminal angioplasty and stent placement for subclavian and brachiocephalic artery stenosis in aortitis syndrome."Cardiovasc.Intervent.Radiol.. 22. 427-432 (1999)

Nomura M、Kida S、Yamashita T 等人：“主动脉炎综合征中锁骨下动脉和头臂动脉狭窄的经皮腔内血管成形术和支架置入术。”Cardiovasc.Intervent.Radiol.. 22. 427-432 (1999)