Radiopaque Shape Memory Polymers for Neurovascular Embolotherapy Applications

用于神经血管栓塞治疗应用的不透射线形状记忆聚合物

• 批准号: 10258642
• 负责人: STEPHEN GOODRICH
• 金额: $ 12.36万
• 依托单位: ENDOSHAPE, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258642
• 关键词: Address; Aneurysm; Biohazardous Substance; Blood Vessels; Brain Aneurysms; C10; Caliber; Catheters; Cessation of life; Crosslinker; Devices; Disadvantaged; Evaluation; Fluoroscopy; Formulation; Generations; Heating; High Pressure Liquid Chromatography; Hour; Hydrogen Peroxide; Hydrolysis; Image; Image-Guided Surgery; In Vitro; Incidence; Intervention; Iodine; Isopropanol; Magnetic Resonance Imaging; Medical Device; Memory; Metals; Methods; Monitor; Morphologic artifacts; Neurologic Deficit; Operative Surgical Procedures; Pathway interactions; Patient Care; Performance; Peripheral; Phase; Phosphate Buffer; Platinum; Polymers; Procedures; Property; Recovery; Risk; Rupture; Safety; Shapes; Side; Small Business Innovation Research Grant; Specimen; Stainless Steel; Surgeon; Technology; Testing; Therapeutic Embolization; Thick; Vacuum; Variant; Weight; X-Ray Computed Tomography; arm; base; biomaterial compatibility; c new; cost; cytotoxicity test; density; experience; follow-up; improved; in vitro Model; in vivo; mechanical properties; minimally invasive; monomer; mortality; neurovascular; next generation; oxidation; radiologist

Radiopaque Shape Memory Polymers for Neurovascular Embolotherapy Applications Project Summary / Abstract This Phase I project involves a major improvement in neurovascular embolotherapy. Aneurysms contribute significantly to annual mortality: an estimated 6.5 million people in the US (~1 in 50) have an unruptured brain aneurysm, with an annual rupture rate of about 8 to 10 in 100,000 people (about 30,000 annually in the US), with fatality in 50% of the rupture cases and an incidence of permanent neurological deficit in 66% of the surviving cases, and nearly 500,000 deaths worldwide annually. The major minimally invasive surgical intervention involves the use of metal-based embolic coils to fill aneurysms. However, metal-based coils impart major artifacts in MRI and CT imaging, and also impart a biohazard heating risk in MRI imaging, complicating critical follow-up post-surgical examinations. Radiopaque shape-memory polymers (SMPs) developed at EndoShape, Inc. were incorporated as coils in the multi-coil MedusaTM first-generation peripheral vascular embolotherapy device. The MedusaTM device, deployed using a large 0.074” catheter, had the required fluoroscopic visibility during deployment because of the multiple radiopaque polymer coils traversing and emerging from the catheter simultaneously as deployed. Leveraging a decision by the FDA in 2006 to re-classify embolic coils as class II devices, the 510(k) clearance of the MedusaTM multi-coil device for peripheral vascular interventions was achieved in 2014, and opened a pathway to 510(k) clearance of next-generation neurovascular devices with radiopaque SMP coils. The radiopaque SMPs used in the MedusaTM device were not sufficiently radiopaque for single-coil devices in the smaller coil wire diameter range that is required for neurovascular applications. Now a new radiopaque monomer, used in combination with more efficient crosslinkers that impart required mechanical properties at lower incorporation, allowing higher incorporation levels of the radiopaque monomer, has enabled required radiopacity to be achieved in a wire diameter range that is estimated to be 0.010”-0.021” while retaining required performance properties, biodurability and biocompatibility. EndoShape is on the verge of being able to apply radiopaque SMPs to neurovascular devices with the advantages first provided to surgeons by the use of the MedusaTM device. The materials-based advantages of EndoShape SMPs obviate the disadvantages of metal coils, including in addition to the improvements in the safety and efficacy of MRI and CT imaging in post-surgical examinations and a reduction in surgical expense due to the lower-cost materials comprising EndoShape polymer-based coils. From 2020-2025 the total embolotherapy device market is forecasted to increase from $1.26 to $1.64 billion (+30.2%), and the market that EndoShape can address with its radiopaque polymer based SMP coils is expected to increase from $0.89 to $1.17 billion (+31.5%); highlighting the impact EndoShape polymer-based coils are capable of exerting in medical device markets and in improved embolotherapy patient care.

放射线形状的记忆聚合物 神经血管栓塞疗法 项目摘要 /摘要 该阶段I项目涉及神经血管栓塞疗法的重大改善。动脉瘤有贡献 大量死亡率：估计在美国有650万人（50分之一）的大脑未破裂 动脉瘤，年破裂率约为100,000人（每年约30,000人），大约8至10 在50％的破裂病例中死亡，有66％存活的永久神经缺陷的事件 案件，每年近50万人死亡。 主要的最低侵入性手术干预涉及使用金属栓塞线圈来填充 动脉瘤。但是，金属线圈在MRI和CT成像中授予主要伪像，并且也赋予 MRI成像中的生物危害加热风险，使手术后检查的关键随访。 在Endoshape，Inc。开发的Radiopaque Shape-Memory聚合物（SMP）作为线圈合并为 在多层甲状腺素第一代外周血血管栓塞装置中。 Medusatm设备， 使用大型0.074”导管部署，在部署过程中具有所需的荧光镜可见性 在部署时，多个辐射聚合物线圈绕过导管并从导管中出现。 利用FDA在2006年的决定将栓塞线圈重新分类为II类设备，510（k） 在2014年实现了用于周围血管干预措施的Medusatm多线圈设备的清除，并且 开辟了通往带有Radiopaque SMP线圈的下一代神经血管设备510（k）的途径。 在Medusatm设备中使用的Radiopaque SMP不足以用于单线装置 在神经血管应用所需的较小线圈线直径范围内。现在是一个新的radiopaque 单体，与更有效的交联链结合使用，这些交联仪赋予需要机械性能 下层成型，允许较高的放射线型单体水平启用 放射线在估计为0.010英寸-0.021英寸的电线直径范围内实现 所需的性能特性，可生物可行性和生物相容性。 Endoshape即将有能力 将Radiopaque SMP应用于神经血管设备，并首先通过使用给外科医生提供优势 Medusatm设备的。 Endoshape SMP的基于材料的优势消除了金属线圈的缺点，包括 除了改善手术后检查中MRI和CT成像的安全性和效率 由于较低的成本材料完成了基于Endoshape聚合物的线圈，因此手术费用的减少。 从2020年至2025年，预计总体疗法设备市场将从1.26美元增加到16.4亿美元 （+30.2％），预计Endoshape可以使用其Radiopaque聚合物线圈来解决的市场 从0.89美元增加到11.7亿美元（+31.5％）；突出构造基于Endoshape聚合物的线圈是 能够在医疗器械市场上施加工作，并在改善的栓塞疗法患者护理中进行。