Improving outcomes in endovascular treatment of intracranial aneurysms: Combining additive manufacturing, in-silico modeling, and shape memory polymers

改善颅内动脉瘤血管内治疗的效果：结合增材制造、计算机建模和形状记忆聚合物

基本信息

批准号：
10685325
负责人：
Chung-Hao Lee
金额：
$ 66.03万
依托单位：
UNIVERSITY OF OKLAHOMA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-23 至 2027-06-30
项目状态：
未结题

项目摘要

Project Summary/Abstract Subarachnoid hemorrhage (SAH) is a devasting acute neurological disease that remains a major cause of premature mortality. SAH is most caused by incidental rupture of an intracranial aneurysm (ICA). The mortality rate of aneurysm rupture can reach as high as 40% within the first week of incidence. Even if the aneurysm is treated in a timely manner, the chance of moderate to severe brain damage is 20-35%. Endovascular coil embolization is the current gold-standard, minimally invasive therapy of ICAs; however, emerging clinical challenges of coil embolization are unsatisfactory aneurysm recurrence rates: ~44% by 5-6 years after the initial coil therapy (of which more than 50% requiring re-treatment), and suboptimal complete occlusion, especially for treating wide-necked ICAs and/or aneurysms with a complex 3D geometry. Thus, there is a need for a durable device to treat unruptured ICAs that targets patient-specific aneurysms and intra-aneurysmal circulation and provides long-lasting complete occlusion. Our research objectives of this project are to: 1) design and fabricate personalized embolic devices for treating saccular, bifurcated IACs using additive manufacturing and a combined experimental/biomechanical approach, and 2) provide a holistic biomechanical and hemodynamic comparison between our device and other selected endovascular embolic techniques. This proposal builds upon the assembled preliminary data, and leverages Dr. Lee’s experience with tissue biomechanics and in-silico modeling, in collaboration with polymer science and additive manufacturing researchers at the University of Oklahoma, clinical and neurosurgical expertise of clinicians at Indiana University – Medicine, and micro-device and catheter expert at Purdue. Specifically, we propose to design, develop, and evaluate patient-specific SMP embolic devices using 3D printing-based polymer fabrication. Our embolic devices are designated to target personalized aneurysm filling and maximize the rate of long-lasting complete occlusion. Next, through in-vitro flow loop testbed and in-vivo small animal studies, the efficacy and aneurysm occlusion of our personalized embolic devices will be systematically evaluated in comparison to the clinical gold standard as well as three other contemporary embolic methods. The endpoint of this project will be a cutting-edge solution for ICA embolization, that uses fundamental information on aneurysms based on holistic biomechanical and hemodynamic analyses – allowing individual-optimized aneurysm filling to achieve immediate & long-term complete occlusion and reduce aneurysm recurrence. Collectively, our developments will serve as a logical first step toward attaining our long- term goal to advance the state of the art in translational medicine by facilitating personalized, preventive management of unruptured ICAs and reduce aneurysm rupture-induced hemorrhagic strokes.

项目概要/摘要蛛网膜下腔出血 (SAH) 是一种毁灭性的急性神经系统疾病，仍然是导致 SAH 的过早死亡主要是由颅内动脉瘤 (ICA) 意外破裂引起。即使动脉瘤在发病第一周内破裂，其破裂率也高达40%。如果治疗及时，血管内弹簧圈造成中度至重度脑损伤的几率为20-35%。栓塞是当前 ICA 的金标准、微创治疗，然而，新兴的临床治疗；弹簧圈栓塞的挑战是动脉瘤复发率不令人满意：初始治疗后 5-6 年约 44% 弹簧圈治疗（其中超过 50% 需要重新治疗）和次优完全闭塞，尤其是对于治疗具有复杂 3D 几何形状的宽颈 ICA 和/或动脉瘤因此，需要一种耐用的。治疗未破裂 ICA 的装置，针对患者特定的动脉瘤和动脉瘤内循环，以及提供持久的完全咬合。我们该项目的研究目标是：1）设计和制造。使用增材制造和组合技术治疗囊状、分叉 IAC 的个性化栓塞装置实验/生物力学方法，2) 提供整体生物力学和血流动力学比较我们的设备和其他选定的血管内栓塞技术之间的关系。收集初步数据，并利用李博士在组织生物力学和计算机模拟方面的经验与大学的聚合物科学和增材制造研究人员合作进行建模俄克拉荷马州印第安纳大学专家的临床和神经外科专业知识 - 医学和微型设备具体而言，我们建议设计、开发和评估患者特异性 SMP。使用基于 3D 打印的聚合物制造的栓塞装置我们的栓塞装置旨在瞄准目标。接下来，通过体外技术，个性化动脉瘤充填并最大限度地提高持久完全闭塞率。流动循环试验台和体内小动物研究，我们个性化的功效和动脉瘤闭塞栓塞装置将与临床金标准以及其他三个标准进行比较进行系统评估该项目的终点将是 ICA 栓塞的尖端解决方案，使用基于整体生物力学和血流动力学分析的动脉瘤基本信息 – 允许个体优化的动脉瘤充填以实现即时和长期的完全闭塞并减少总的来说，我们的发展将成为实现我们长期目标的合理的第一步。术语目标是通过促进个性化、预防性的促进转化医学的最先进水平管理未破裂的 ICA 并减少动脉瘤破裂引起的出血性中风。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A Bayesian constitutive model selection framework for biaxial mechanical testing of planar soft tissues: Application to porcine aortic valves.

用于平面软组织双轴机械测试的贝叶斯本构模型选择框架：在猪主动脉瓣上的应用。

DOI：
发表时间：
2023-02
期刊：
影响因子：
0
作者：
Aggarwal, Ankush;Hudson, Luke T;Laurence, Devin W;Lee, Chung;Pant, Sanjay
通讯作者：
Pant, Sanjay

Modulation of Smooth Muscle Cell Phenotype for Translation of Tissue-Engineered Vascular Grafts.

调节平滑肌细胞表型以翻译组织工程血管移植物。

DOI：
发表时间：
2023-10
期刊：
影响因子：
0
作者：
Pineda;Acar, Handan;Detamore, Michael S;Holzapfel, Gerhard A;Lee, Chung
通讯作者：
Lee, Chung

Linking the region-specific tissue microstructure to the biaxial mechanical properties of the porcine left anterior descending artery.

将区域特异性组织微观结构与猪左前降支的双轴机械特性联系起来。

DOI：
10.2139/ssrn.4065268
发表时间：
2022-07-01
期刊：
Acta biomaterialia
影响因子：
9.7
作者：
Sergio A. Pineda;Santiago Aparicio;M. Burns;Devin W. Laurence;Elizabeth Bradshaw;Tingting Gu;G. Holzapfel;Chung
通讯作者：
Chung

An investigation of how specimen dimensions affect biaxial mechanical characterizations with CellScale BioTester and constitutive modeling of porcine tricuspid valve leaflets.

使用 CellScale BioTester 和猪三尖瓣小叶的本构模型研究样本尺寸如何影响双轴机械特性。

DOI：
发表时间：
2023-10-05
期刊：
影响因子：
2.4
作者：
Laurence, Devin W;Wang, Shuodao;Xiao, Rui;Qian, Jin;Mir, Arshid;Burkhart, Harold M;Holzapfel, Gerhard A;Lee, Chung
通讯作者：
Lee, Chung

Strain energy density as a Gaussian process and its utilization in stochastic finite element analysis: application to planar soft tissues.

作为高斯过程的应变能量密度及其在随机有限元分析中的应用：在平面软组织中的应用。