5 Developing a novel stent concept in the management of bifurcation disease
5 Developing a novel stent concept in the management of bifurcation disease
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5 开发治疗分叉疾病的新型支架概念
DOI：
10.1136/heartjnl-2016-309588.5
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发表时间：
2016
期刊：
影响因子：
5.7
通讯作者：
Banning A
中科院分区：
文献类型：
--
作者：
Banning A
简介临时支架置入术是公认的分叉疾病治疗方法，但针对 1:1:1 疾病的技术和支架可能会产生次优结果。我们开发了一种新颖的支架，旨在将球囊原位修改为任何分叉角度，而支架材料不会进入主管或侧支管腔。方法通过以下设计讨论以及与我们的非商业行业合作伙伴进行的广泛有限元分析研究，两个原型（ST04 和 ST05）由钴铬激光切割而成。体外测试包括对 2 个形状（λ、Y）和 3 个角度（45o、60o、75o）、n = 36 的硅胶分叉模型进行详细的定量 Micro-CT 和视频评估。对原型的抗压性能进行了评估。结果两个原型都显示出成功的纵向缩短（图 1）。在 λ-60o 范围内，从支架支柱到血管壁的平均距离为 0.11+/-0.04 毫米（ST04）、0.09+/-0.02 毫米（ST05），表明对置良好，没有突出到任一管腔中。可延展部分的抗压强度低于标准部分（例如：ST04可延展端= 0.13+/-0.01N/mm；常规部分=0.32+/-0.01N/mm p < 0.001）。结论结果表明具有可延展端的支架可以与侧分支口良好贴合。这可能会转化为双支架策略在真正的分叉病变中的更好结果。
IntroductionsProvisional stenting is the accepted treatment for bifurcation disease, but techniques and stents for 1:1:1 disease can give sub-optimal results. We have developed a novel stent designed to be balloon modified in-situ to any bifurcation angle with no ingression of stent material into the main or side-branch lumen.MethodsFollowing design discussions, and extensive Finite Element Analysis studies with our non-commercial Industry partner two prototype (ST04 and ST05) were laser cut from cobalt chromium. In-vitro testing included detailed quantitative Micro-CT and video evaluation in silicone bifurcation models of 2 shapes (λ, Y) and 3 angles (45o, 60o,75o), n = 36. Prototypes were assessed for crush resistance.ResultsBoth prototypes showed successful longitudinally shortening (Figure 1). Mean distance from stent strut to vessel wall was 0.11+/-0.04mm (ST04), 0.09+/-0.02mm (ST05) in λ-60o indicating excellent apposition, with no protrusion into either lumen. Crush resistance in the malleable part was lower than the standard section (eg: ST04 malleable end = 0.13+/-0.01N/mm; regular part=0.32+/-0.01N/mm p < 0.001).ConclusionsThe results show proof-of-concept that a stent with a malleable end can be conformed to the side branch ostium with good apposition. This may translate into better outcomes for two-stent strategies in true bifurcation lesions.